Mineralys Terapéutica, Inc. - S-1/A - Registration Statement - February 2, 2023 (2023)

As filed with the Securities and Exchange Commission on February 2, 2023

Registration number 333-269282

US

SECURITY AND REPLACEMENT COMMITTEE

Washington, D.C. 20549

AMENDMENT #1

PRO

FORMULAR S-1

REGISTRATION STATEMENT

SOB

THE SECURITIES ACT OF 1933

MINERALYS THERAPEUTICS, INC.

(Exact name of the registrant according to its statutes)

150 N. Radnor Chester Road, Suite F200

Radnor, PA 19087

888-378-6240

(Address, including zip code and telephone number, including area code, of the applicant's main office)

Jon Congleton

chairman

Mineralys Therapeutics, Inc.

150 N. Radnor Chester Road, Suite F200

Radnor, PA 19087

(888) 378-6240

(Name, address including postal code and telephone number including area code of the service provider)

Copies to:

Approximate date of commencement of offering for sale to the public:As soon as reasonably practicable after this Registration Statement is declared effective.

If any of the securities listed on this form are being offered on a delayed or continuous basis under Rule 415 of the Securities Act of 1933, please check the box below. ☐

If this form is being submitted to register additional securities in an offering pursuant to Rule 462(b) under the Securities Act, please check the box below and provide the Securities Act Registration Statement number from the registration statement of the previous effective order for the same offering at. ☐ ___________

If this form is a retrospective amendment filed under Rule 462(c) of the Securities Act, please check the box below and provide the Securities Act Registration Statement Number from the previous effective registration statement for the same offering. ☐ ___________

If this form is a retrospective amendment filed under Rule 462(d) of the Securities Act, please check the box below and include the Securities Act Registration Statement Number from the previous effective registration statement for the same offering. ☐ ___________

Tick ​​to indicate if the registrant is a large expedited submitter, expedited submitter, non-expedited submitter, smaller reporting company, or emerging growth company. See definitions of "large accelerated filer", "accelerated filer", "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

If this is an emerging growth company, indicate with a tick whether the registrant has elected not to use the extended transition period to comply with new or revised accounting standards required under Section 7(a)(2)(B ) of the Securities Act. ☐

Registrant hereby amends this Registration Statement as of the date or dates necessary to defer the Effective Date until Registrant files an additional amendment expressly stating that this Registration Statement is subject to Section 8(a) of the Securities Act of 1933, as amended, or until the Declaration of Registration becomes effective on such date as the Commission may determine in accordance with Section 8(a) referred to.

The information contained in this preliminary prospectus is not exhaustive and is subject to change. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission becomes effective. This Prospectus does not constitute an offer to sell these securities and does not solicit an offer to buy these securities in any jurisdiction in which the offering or sale is not permitted.

Subject to completion

Preliminary Prospectus dated February 2, 2023

P R O S P E K T U S

10.000.000Actions

Common stock

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This is the IPO of Mineralys Therapeutics, Inc. We are selling 10,000,000 common shares.

We anticipate that the public offering price of our common shares will be between $14.00 and $16.00 per share. There is currently no public market for our common stock. We are seeking approval to list our common stock on the Nasdaq Global Market under the symbol "MLYS" and this offering is conditioned on our obtaining such approval.

We are an Emerging Growth Company and a Minor Reporting Company under the federal securities laws and are subject to reduced public company disclosure standards. See the section entitled "Summary of the Prospectus - Implications if it is an Emerging Growth Company and a Smaller Reporting Company".

Investing in our common stock involves risks, which are described in the “Risk Factors” section at the top of this page.12dieses Prospectus.

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(1)We have referred you to “Underwriting” for more information on underwriting.

Subscribers may also exercise their option to purchase up to 1,500,000 additional common shares from us at the initial issue price less the subscription discount within 30 days of the date of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or determined the accuracy or completeness of this prospectus. Any statement to the contrary is punishable.

The shares will be ready for delivery around 2023.

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The date of this prospectus is 2023.

INDEX

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Neither we nor the Underwriters authorize anyone to provide you with any information other than that contained in this Prospectus or any free written prospectus prepared by us or on our behalf or to which we refer you. Neither we nor the subscribers accept liability and cannot make any guarantees as to the reliability of any other information that others may make available to you. We and the underwriters are only making offers for sale and soliciting offers to buy shares of our common stock in jurisdictions where offers and sales are permitted. The information contained in this prospectus or any draft prospectus is accurate only as of its date, regardless of its delivery date or any sale of any portion of our common stock. Our business, financial condition, results of operations and outlook may have changed since that date.

For Investors Outside the United States: We and the Underwriters have not taken any action to permit this offering, possession or distribution of this Prospectus in any jurisdiction where appropriate action is required, other than the United States. Persons outside of the United States who receive this Prospectus should inform themselves of and observe any restrictions relating to the offering of Common Stock and the distribution of this Prospectus outside of the United States.

RISK FACTORS

Investing in our common stock involves a high level of risk. You should carefully consider the risks and uncertainties described below together with all other information in this Prospectus, including our financial statements and related notes contained elsewhere in this Prospectus and in “Management's Discussion and Review of Financial Condition and Results of Operations”. Before you do this make an investment decision. Other risks and uncertainties that we do not currently consider material or of which we are currently unaware could become important factors affecting our future financial condition and financial performance. If any of these or the following risks materialize, our business, financial condition, results of operations and prospects could be materially and adversely affected. In this event, the trading price of our common stock may decrease and you may lose all or part of your investment.

Risks related to our limited operating history, financial condition and capital requirements

We have limited operating history, have suffered significant operating losses since inception and expect to incur significant losses for the foreseeable future. We may never generate revenue or become profitable, or if we achieve profitability we may not be able to sustain it.

Biopharmaceutical development is a highly speculative endeavor and involves significant risk. We are a clinical-stage biopharmaceutical company with limited operating history upon which to evaluate our business and prospects. We started our business in 2019 and so far our focus has been on organizing and staffing our business, business planning, raising capital, licensing our product candidate lorundrostat, building our intellectual property portfolio and conducting research, pre-clinical studies and clinical studies concentrated. We have not yet completed critical clinical trials, received regulatory approvals, manufactured any product on a commercial scale or engaged a third party to do so on our behalf, or engaged in any sales and marketing activities necessary for the successful commercialization of the product. As a result, any predictions about our future success or profitability may not be as accurate as they could be if we had a successful track record of developing and commercializing biopharmaceuticals.

We have suffered significant operating losses since inception and expect to incur significant losses for the foreseeable future. We have no approved products for sale and we have not made any revenue to begin with. Unless lorundrostat is successfully developed, approved, and commercialized, we may never see significant revenue, if any. Our net losses were $19.4 million and $20.7 million for the year ended December 31, 2021 and the nine months ended September 30, 2022, respectively. As of December 31, 2021 and September 30, 2022 we had an accumulated deficit of $23.0 million and $43.7 million, respectively. Substantially all of our losses result from expenses incurred in connection with the licensing of lorundrostat-related intellectual property and the development of lorundrostat, as well as general and administrative expenses associated with our operations. Lorundrostat and any future product candidates will require significant additional development time and resources before we can apply for or receive regulatory approvals and begin generating revenue from product sales. We expect to continue to incur losses for the foreseeable future and expect these losses to increase significantly as we continue our development, obtain regulatory approval and potentially commercialize lorundrostat, seek related licensed intellectual property identify, evaluate, acquire or develop additional product candidates and become a public company.

In order to become and remain profitable, we must develop products, obtain regulatory approvals, and ultimately commercialize products that generate significant revenue. This requires us to be successful in a number of challenging activities, including completing clinical trials and pre-clinical studies for lorundrostat and all future product candidates, acquiring additional product candidates, obtaining regulatory approval for lorundrostat and all future product and manufacturing candidates, Marketing and selling products for which we may obtain regulatory approval. We are only in the early stages of most of these activities. We may never be successful in these activities, and even if we do, we may never generate sufficient revenue to reach profitability. In addition, we have yet to demonstrate the ability to successfully navigate many of the risks and uncertainties that companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry, often face. Because of the many risks and uncertainties associated with the development of biopharmaceuticals, we cannot accurately predict the timing or amount of increased spending, or when or if we will be able to do so

achieve profitability. Even if we achieve profitability, we may not be able to maintain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could adversely affect the value of our company and affect our ability to raise capital, grow our business, sustain our research and development efforts, diversify our product candidates, achieve our strategic goals, or even to continue our operations. A decline in the value of our company could also result in you losing all or part of your investment.

We will require significant additional capital to fund our objectives, and failure to raise this necessary capital when needed, on acceptable terms, or at all, could force us to delay, curtail, reduce or reduce our development programs, commercialization efforts or other operations to end.

The development of biopharmaceutical product candidates is capital intensive. We expect our expenses to increase significantly relative to our ongoing operations, particularly as we conduct our ongoing and planned clinical trials for lorundrostat and potentially seek regulatory approval for lorundrostat and any future product candidates we may develop and a public one become a company. Additionally, if we succeed in advancing lorundrostat through development and commercialization, we will have to pay milestone and royalties to Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe), from which we have licensed intellectual property related to lorundrostat. If we receive regulatory approval for lorundrostat or a future product candidate, we also anticipate significant business expenses associated with manufacturing, marketing, selling and distributing the product. Because the outcome of any clinical study or pre-clinical study is highly uncertain, we cannot reliably estimate the actual amount of funding that will be required to successfully complete the development and commercialization of lorundrostat or any future product candidate. In addition, upon completion of this offering, we anticipate additional costs associated with operating as a public company. As a result, we need to source significant additional resources related to our ongoing operations. If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce or halt our research and development programs or future commercialization efforts.

Based on our current plan of operations, we believe that the net proceeds from this offering, together with our cash, cash equivalents and marketable securities, will enable us to fund our operations for at least 18 months from the date of this prospectus. We base these estimates on assumptions that may be incorrect and we may deplete our capital resources sooner than we currently expect. Our operating plans and other cash requirements are subject to change due to many factors that are currently unknown to us and we may need to seek additional resources ahead of schedule. The net proceeds from this offering, combined with our existing cash and earmarked cash, may not be sufficient to complete the development of lorundrostat or future product candidates, and post this offering we will require significant capital to advance lorundrostat and any future product candidates through clinical trials, regulatory approval and commercialization. As a result, we need to source significant additional resources related to our ongoing operations. Our ability to raise additional funds may be hampered by the potential for deteriorating global economic conditions and disruptions and volatility in financial and credit markets in the United States and around the world resulting from factors such as, but not limited to , Inflation, conflicts between Russia and Russia result in Ukraine and other factors, lower liquidity and credit availability, falling consumer confidence, declining economic growth, rising unemployment rates and uncertainty about economic stability. If equity and credit markets deteriorate, it could make necessary debt or equity financing more difficult, expensive and dilutive. If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, scale back or halt our research and development programs or future commercialization efforts, or even cease operations. We anticipate that we will meet our liquidity needs through public or private equity or debt financing or other sources of capital, including possible collaborations, licensing and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even when we believe we have adequate resources for our current or future operating plans. Attempting to obtain additional funding could distract our management from our day-to-day activities, which could impact our ability to develop lorundrostat and future product candidates.

Our future capital needs will depend on many factors including but not limited to:

•Initiation, nature, number, scope, progress, extensions, results, costs and timing of clinical trials and pre-clinical trials of lorundrostat and any future product candidates that we may pursue,

including any changes to clinical development plans based on feedback we may receive from regulatory authorities;

•the cost and time to manufacture lorundrostat or any prospective product candidate, including commercial manufacturing on a sufficient scale if a product candidate is approved, including as a result of inflation, supply chain issues or component shortages;

•regulatory requirements in additional jurisdictions in which we are seeking regulatory approval for lorundrostat and future product candidates and our anticipated timeline for filing in those jurisdictions;

•the cost, timing and outcome of regulatory meetings and reviews of lorundrostat or future product candidates;

•delays and cost increases that may result from COVID-19 or any future pandemic;

•the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights;

•our efforts to improve operating systems and hire additional staff to meet our obligations as a public company, including improved internal controls over financial reporting;

•the costs associated with hiring additional staff and consultants as our business grows, including additional directors and clinical development, regulatory, CMC quality and commercial staff;

•the term and amount of any milestone payments, royalties or other payments we are required to make to Mitsubishi Tanabe, from which we license Lorundrostat, or to prospective licensors;

•the cost and time of establishing or securing sales and marketing capabilities if lorundrostat or a future product candidate is approved;

•our ability to achieve sufficient market acceptance, coverage and reimbursement from third-party payers, and market share and revenue for approved products;

•our ability and strategic decision to develop future product candidates beyond lorundrostat and the timing of such development, if any;

•the willingness of patients to pay for approved products out-of-pocket in the absence of adequate coverage and/or reimbursement from third-party payers;

•the conditions for establishing and maintaining collaborations, licenses and other similar agreements; And

•Costs related to products or technology that we may license or acquire.

Conducting clinical and pre-clinical studies and potentially identifying future product candidates is a time-consuming, expensive and uncertain process that takes years, and we may never generate the data or results necessary to obtain regulatory approval and commercialization of lorundrostat or other future product candidates are required. If approved, lorundrostat and any future product candidates may not be commercially successful. Our commercial income, if any, will initially come from the sale of lorundrostat, which we do not expect to be commercially available for many years, if ever. As such, we will continue to rely on additional funds to achieve our business goals. Appropriate additional financing may not be available to us on acceptable terms or at all.

Raising additional capital may result in dilution for our shareholders, including purchasers of common stock in this offering, restrict our operations, or require us to relinquish rights in our candidate technologies or products.

If we are able to generate significant product revenue to date, we expect to be able to meet our liquidity needs through equity offerings, debt financing or other sources of capital, including potential collaborations, licensing and other similar arrangements. We have no set external funding source. To the extent that we raise additional capital through the sale of stock or convertible debt securities, your interest in ownership may be diluted and the terms of such securities may involve liquidation or other preferences that affect your rights as a common shareholder. Debt financing and preferred stock financing, when available, may include agreements that contain provisions that restrict or restrict our ability to take certain actions, such as: B. taking on additional debt, investing or declaring dividends. Such restrictions could affect our ability to conduct our business and implement our business plan.

If we raise additional funds through future collaborations, licenses and other similar agreements, we may have to relinquish valuable rights in our future revenue streams, product candidates, research programs, intellectual property or proprietary technology, or license on terms that may not be favorable to us and/or decrease the value of our common stock. If we are unable to raise additional funds through equity or debt financing or other arrangements as needed or on terms acceptable to us, we must delay, limit, reduce or terminate our future product development or commercialization efforts, or grant development rights and product candidates commercialize that we would otherwise prefer to develop and commercialize ourselves, or on less favorable terms than we would choose.

Risks related to the development and regulatory approval of our product candidates

We are currently fully dependent on the success of our only product candidate, lorundrostat. If we are unable to advance lorundrostat to clinical development, receive regulatory approval, and ultimately commercialize lorundrostat, or experience significant delays in doing so, our business will be materially hurt.

We currently have only one product candidate, lorundrostat, whose intellectual property we are in-licensing and is in Phase 2 clinical development. Our business currently depends entirely on our ability to successfully develop lorundrostat, receive regulatory approval and commercialize it in a timely manner. This may make an investment in our company more risky than comparable companies that have multiple product candidates in active development and may be better able to absorb the delay or failure of a key product candidate. In addition, our assumptions about the development potential of lorundrostat are based in part on data obtained from pre-clinical studies and clinical studies conducted by our licensor, and we may observe significantly and adversely different results as we continue our clinical studies. The success of lorundrostat depends on several factors, including the following:

•successful initiation and registration of clinical trials and completion of clinical trials with favorable results;

•acceptance of regulatory submissions by the FDA or similar foreign regulatory authorities to conduct pre-clinical studies and clinical studies of lorundrostat and our proposed design of planned clinical studies and clinical studies of lorundrostat;

•the frequency and severity of adverse events in pre-clinical and clinical studies;

•Maintaining relationships with pre-clinical providers to ensure the successful completion of pre-clinical studies with favorable outcomes, including toxicology and other studies designed to comply with good laboratory practice (GLP);

•Maintaining and developing relationships with Contract Research Organizations (CROs) and clinical centers for the clinical development of lorundrostat and the ability of such CROs and clinical centers to comply with clinical study protocols, current good clinical practices (cGCPs) and other applicable requirements;

•demonstrate the safety and efficacy of lorundrostat to the satisfaction of the relevant regulatory authorities, including the establishment of a safety database of sufficient size for the regulatory authorities;

•Obtaining and maintaining marketing authorizations from relevant regulatory authorities for initial and additional indications;

•maintain relationships with our third party manufacturers and their ability to comply with current Good Manufacturing Practices (cGMPs) and enter into agreements with our third party manufacturers or build our own commercial manufacturing capabilities at a price and scale sufficient to support commercialization;

•Establishing sales, marketing and distribution capabilities and initiating commercial sales of lorundrostat, if and when authorized, alone or in collaboration with others;

•obtaining, establishing, maintaining and enforcing patents and potential trade secret or governmental exclusivity protection for lorundrostat;

•maintaining an acceptable safety profile of lorundrostat following regulatory approval, if any;

•maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell lorundrostat; And

•Acceptance of our products, where approved, by patients, the medical community, and third-party payers.

If we are unable to develop, obtain regulatory approval, and successfully commercialize lorundrostat, or if we experience delays due to any of the factors above or otherwise, our business will be materially harmed.

Clinical and pre-clinical development involves a time-consuming and expensive process with uncertain timeframes and results, and the results of previous clinical trials and studies of lorundrostat are not necessarily predictive of future results. Lorundrostat may not achieve favorable results in our non-clinical studies or clinical trials, or receive regulatory approval in a timely manner, if at all.

Clinical and pre-clinical development is expensive and can take many years, and its outcome is inherently uncertain. We cannot guarantee that clinical trials or pre-clinical studies will be conducted as planned or completed on time, if at all, and failure can occur at any time during the trial or study process. Despite promising preclinical or clinical results, any product candidate may fail unexpectedly at any stage of clinical development. The historical failure rate for product candidates in our industry is high, especially in the early stages of development.

The results of pre-clinical studies or clinical studies of a product candidate or a competitor's product candidate in the same class may not be predictive of the results of further clinical studies of our product candidate, and the interim, main or preliminary results of a clinical study are not necessarily indicative of the final results Clues. Product candidates in later stages of clinical trials may not have the desired safety and efficacy characteristics, despite advances in preclinical studies and early clinical trials. For example, although we completed the Target-HTN Phase 2 clinical trial of lorundrostat with 200 patients who completed eight weeks of treatment or discontinued the study, this population represents a small sample size compared to our targeted enrollment into our planned clinics. As a result, we do not know how lorundrostat will perform in future clinical trials. It is not uncommon to see unexpected results in clinical trials based on previous clinical trials and pre-clinical studies, and many product candidates fail in clinical trials despite very promising initial results. Several companies in the biopharmaceutical and biotechnology industry have suffered significant setbacks in clinical development, even after showing promising results in previous studies. Such mishaps have occurred and may occur for a variety of reasons, including but not limited to: clinical sites and investigators may deviate from clinical trial protocols, whether due to lack of training or other reasons, and we may not be able to identify such deviations in a timely manner ; Patients may not comply with required clinical study procedures, including post-treatment follow-up requirements; our product candidates may not demonstrate efficacy or safety in certain patients

Subpopulations not observed in previous studies due to limited sample size, lack of analysis, or other reasons; or our clinical studies may not adequately represent the patient populations we wish to treat, whether due to limitations in our study design or for other reasons, e.g. B. when a subgroup of patients is over-represented in the clinical study. There's no guarantee we won't experience similar setbacks, despite the data we've seen in previous or ongoing studies. Based on negative or inconclusive results, we or a prospective collaborator may decide, or regulatory authorities may require us to conduct additional pre-clinical studies or clinical studies, which would result in additional operating costs and delays and may not be sufficient to support regulatory approval in time or at all.

Therefore, we cannot be certain that our ongoing and planned clinical trials and preclinical studies will be successful. Any safety concerns identified in any of our clinical trials in our specific indications could limit lorundrostat's prospects for regulatory approval in these and other indications, which could have a material adverse effect on our business, financial condition, results of operations and prospects .

Any difficulties or delays in initiating or completing, or terminating or suspending, our ongoing or planned clinical trials or pre-clinical trials could result in increased costs for us, delay or limit our ability to generate revenue, or adversely affect our business prospects.

Before we receive marketing approval from regulatory authorities to sell lorundrostat or any future product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans. Before we can begin clinical studies for future product candidates, we must submit the results of preclinical studies along with other information, including information about the chemistry, manufacturing and controls of the product candidate and our proposed clinical trial protocol to the FDA or similar foreign regulatory agency, as part a new drug application (IND) or similar regulatory submission. The FDA or similar foreign regulatory agency may require us to conduct additional preclinical studies for any candidate product before we can begin clinical studies as part of an IND or similar regulatory filing, which may cause delays and increase our program costs. In addition, even when we initiate clinical trials, issues may arise that may cause regulatory authorities to suspend or terminate such clinical trials. Any delays in the initiation or completion, termination or suspension of our ongoing and planned clinical or pre-clinical studies for lorundrostat and any future product candidate could materially impact our product development plans and product development costs.

We do not know if our planned clinical trials and pre-clinical trials will start on time or, if at all, will be completed on time. The initiation, data reading, and completion of clinical and preclinical studies may be delayed for a variety of reasons, including delays related to:

•inability to obtain animals or materials to initiate and generate sufficient pre-clinical, toxicological or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

•obtain permission from regulators to initiate a test or to reach consensus with regulators on the test design;

•the FDA or similar foreign regulators disagree about the design or conduct of our clinical trials;

•any failure or delay in reaching an agreement with CROs and clinical study sites, the terms of which may be subject to extensive negotiation and may vary significantly between different CROs and study sites;

•delays in identifying, recruiting and training appropriate clinical investigators;

•Obtaining approval from one or more institutional review boards (IRBs) or ethical committees (ECs) at clinical trial sites;

•IRBs/CBs who refuse to approve, suspend or terminate the study at a site, prevent enrollment of additional participants, or revoke their approval of the study;

•major changes or additions to the clinical study protocol;

•clinical centers that deviate from the study protocol or discontinue a study;

•failure of our CROs to comply with cGCP requirements or applicable regulatory guidelines in other countries;

•sourcing raw materials to manufacture sufficient quantities of lorundrostat or sourcing sufficient quantities of combination therapies or other materials needed for use in clinical and preclinical studies;

•procurement of suitable materials for packaging material for clinical trials;

•expiry of clinical material for use in clinical trials prior to enrollment in any of our clinical trials;

•Individuals who have not enrolled or remained in our studies at the frequency we expect, or who have not returned for post-treatment follow-up, including individuals who are not in ours due to mobility limitations, medical conditions, or other reasons arising therefrom Studies have remained COVID-19 pandemic or future public health issues;

•individuals who choose an alternative product for the indications for which we are developing lorundrostat or future product candidates, or who participate in competing clinical trials;

•lack of sufficient funding to continue clinical trials, preclinical studies or manufacturing or incur higher than anticipated costs;

•Individuals experiencing serious or unexpected serious drug-related side effects;

•occurrence of serious adverse events in studies of agents of the same class conducted by other companies that may be considered similar to lorundrostat or a future product candidate;

•selection of clinical parameters that require longer clinical observation times or extensive analysis of the resulting data;

•relocation of manufacturing processes to large-scale facilities operated by a contract manufacturing organization (CMO), delays or failure by our CMOs or us to make necessary changes to such manufacturing process, or failure by our CMOs to manufacture test materials in accordance with cGMP regulations or other applicable requirements; And

•Third parties who do not want to or are unable to fulfill their contractual obligations towards us on time.

In addition, disruptions caused by the COVID-19 pandemic may increase the likelihood that we will encounter such difficulties or delays in initiating, registering, conducting or completing our planned and ongoing clinical trials.

Clinical trials must be conducted in accordance with the legal requirements, regulations, or guidelines of the FDA and other applicable regulatory agencies, and are subject to oversight by those governmental agencies and ECs or IRBs in the medical facilities where clinical trials are conducted. Delays may also occur if a clinical trial is suspended or terminated by us, the IRBs of the institutions where such trials are being conducted, by a privacy oversight body for that trial, or by the FDA or similar foreign regulators. These authorities may impose such a suspension or termination due to a variety of factors, including failure to conduct the clinical trial in accordance with the GCP and other regulatory requirements or our clinical protocols, inspection of the clinical trial operations or study site by the FDA, or a equivalent regulatory authorities foreign authorities that result in the imposition of a clinical suspension, unexpected safety issues or adverse reactions, failure to demonstrate benefit from use of a drug, changes in government regulation or administrative action, or lack of adequate funding to continue the clinical trial. For example, for the Phase 2 clinical trial of lorundrostat, the IRB closed one of the clinical sites due to non-compliance with the study protocol and GCP. In addition, regulatory requirements and guidelines may change, and we may need to change clinical study protocols to comply with them

these changes. Changes may result in us resubmitting our clinical trial protocols to the IRBs for re-examination, which may impact the cost, timing or successful completion of a clinical trial.

In addition, conducting clinical trials abroad, such as those conducted for lorundrostat and to be conducted in the future for lorundrostat or any future product candidate, poses additional risks that may delay the completion of our clinical trials. These risks include the failure of participants enrolled abroad to adhere to clinical protocols due to differences in healthcare services or cultural customs, dealing with additional administrative burdens associated with foreign regulatory regimes, and political and economic risks, including war, relevant to this are abroad.

In addition, principal investigators of our clinical trials may, from time to time, act as scientific advisors or consultants to us and receive remuneration in connection with such services. We may be required to report some of these relationships to the FDA or similar foreign regulators. The FDA or similar foreign regulatory agency may determine that a financial relationship between us and a principal investigator created a conflict of interest or influenced the interpretation of the study. As a result, the FDA or a similar foreign regulatory agency may question the integrity of the data generated at each clinical trial site and the usefulness of the clinical trial itself may be compromised. This could result in a delay in the approval or rejection of our regulatory submissions by the FDA or similar foreign regulatory agency, as the case may be, and could result in the denial of marketing approval for one or more of our candidate products.

In addition, many of the factors that cause or result in the termination or suspension or delay in commencement or completion of clinical trials may also ultimately result in the denial of regulatory approval for a product candidate. We may make changes to the formulation or manufacture of lorundrostat or future product candidates; In this case, we may need to conduct additional pre-clinical studies or clinical trials to link our modified product candidates to previous versions. Resulting delays in our clinical trials could shorten the time that we may have the exclusive right to commercialize our candidate products. In these cases, our competitors may bring products to market ahead of us, and the marketability of lorundrostat or other future product candidates may be significantly limited. Any of these events could adversely affect our business, financial condition and prospects.

We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays in enrolling patients into our clinical trials, our clinical development activities may be delayed or adversely affected.

For the successful and timely completion of clinical trials, we must identify and enroll a specific number of patients for each of our clinical trials. We may not be able to initiate or continue clinical trials for lorundrostat or any future product candidate if we are unable to identify and enroll a sufficient number of eligible patients to participate in those trials, as directed by the FDA or similar regulatory bodies outside of the United States required states. Subject enrollment, a key factor at the time of clinical trials, is influenced by many factors, including the size and characteristics of the patient population, proximity of patients to clinical centers, study eligibility and exclusion criteria, and clinical study design, the ability to obtain and maintain informed consent, the risk that enrolled patients will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate skills and experience and competing clinical trials, and physician and patient perceptions of the potential benefits and risks of testing the candidate product versus other available therapies, including any new products that will be approved for the indications we are investigating and any candidate products in development. We must identify and enroll a sufficient number of patients for each of our clinical trials and adequately monitor these patients during and after treatment. Potential patients for planned clinical trials may not be properly diagnosed or identified with the diseases we are targeting, which may adversely affect the results of our trials and raise safety concerns for potential patients. Potential patients for planned clinical trials may also not meet eligibility criteria for such trials.

Additionally, other pharmaceutical companies targeting the same diseases are recruiting patients for clinical trials in these patient populations, which could make it difficult for us to fully enroll our clinical trials. We may not be able to initiate or continue clinical trials if we are unable to find a sufficient number of eligible patients to participate in clinical trials as required by the FDA or similar foreign regulatory authorities. In addition, the process of finding and recruiting patients can be expensive. The timing of our clinical trials depends in part on this

Speed ​​with which we can recruit patients to participate in our studies and conduct necessary follow-up periods. The eligibility criteria for our clinical trials, once determined, may further limit the pool of available participants. If patients are unwilling or unable to participate in our studies for any reason, including the existence of concurrent clinical trials for similar target populations, the availability of approved or licensed therapies, the impact of the COVID-19 pandemic, or the fact that the Enrollment in our studies may prevent patients from taking another product or otherwise have difficulty recruiting a sufficient number of patients, and the timelines for recruiting patients, conducting studies and obtaining regulatory approvals for our product candidates may be delayed . Our inability to enroll a certain number of patients in any of our future clinical trials would result in significant delays or result in our discontinuing one or more clinical trials altogether. Additionally, we have, and will continue to, rely on CROs and clinical trial centers to ensure the proper and timely conduct of our clinical trials and pre-clinical studies. Although we have agreements in place that govern your Services, we have limited control over their actual performance.

We cannot guarantee that our assumptions used to determine expected clinical trial timelines are correct or that we will not experience registration delays or difficulties or be requested by the FDA or any other regulatory body to increase our registration resulting in a delay in Completion would result in testing beyond our expected deadlines.

The use of lorundrostat or any prospective product candidate may be associated with adverse effects, adverse events, or other properties or safety risks that may delay or prevent regulatory approval, cause us to suspend or cancel clinical trials, abandon a product candidate, limit the marketing profile of an approved one Labels or result in other material adverse consequences that could seriously affect our business, prospects, results of operations and financial condition.

As with biopharmaceuticals in general, side effects are likely to be associated with lorundrostat or the use of future product candidates. The results of our clinical studies may indicate an unacceptably high severity and prevalence of expected or unexpected side effects or unexpected features. Adverse reactions caused by our product candidates, when used alone or in combination with approved or investigational drugs, may result in our or regulatory authorities stopping, delaying, or suspending clinical trials and may result in more restrictive labeling or a Delays or refusals of regulatory approvals result, for example, from the FDA or comparable foreign regulatory authorities. Drug-related adverse events may affect patient recruitment or the ability of enrolled patients to complete the study, or lead to potential product liability claims. Any of these events could seriously affect our business, prospects, results of operations and financial condition.

Additionally, if lorundrostat or future product candidates are associated with adverse events in clinical trials or exhibit unexpected properties, we may decide to discontinue their development or limit their development to narrower applications or subpopulations where the adverse events or other properties are less common , less severe or more acceptable from a risk-benefit perspective, which may limit commercial expectations for the candidate product if approved. We may also need to change our development plans and clinical trials based on the results of our ongoing clinical trials. Many compounds that initially showed promise in early testing were later found to cause side effects that prevented further development of the compounds.

It is possible that more illnesses and injuries will occur as we test lorundrostat or future product candidates in larger, longer, and more extensive clinical trials, including with different dosing regimens, or as use of these product candidates becomes more widespread following regulatory approval, disorders, and other undesirable effects Events observed in previous studies, as well as new conditions that have not occurred or been identified in previous studies, can be discovered. If such side effects become known later in development or post-approval, such discoveries could materially adversely affect our business, financial condition and prospects.

If lorundrostat or a prospective product candidate receives marketing approval and we or others later discover undesirable side effects caused by such a product, there could be a number of potentially significant adverse consequences, including:

•Regulatory authorities may revoke, suspend or limit approvals for such a product or seek an injunction against its manufacture or sale;

•we may need to recall a product or change the way that product is given to patients;

•Regulatory authorities may require additional warnings on the label, e.g. B. A “black box” warning or contraindication;

•We may need to change the way a product is distributed or administered, conduct additional clinical trials or change a product's labeling, or conduct additional post-marketing or surveillance studies;

•we could be sued and held liable for harm done to patients;

•Product sales may decrease significantly or the product may become less competitive; And

•our reputation could suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of a particular product candidate, if approved, and could materially adversely affect our business, results of operations and prospects.

Our efforts to investigate lorundrostat in other indications may not be successful. We may expend our limited resources to pursue, acquire or license a new product candidate or specific indication for lorundrostat and fail to take advantage of candidates or product indications that may be more viable or have a greater likelihood of success.

Due to our limited financial and administrative resources, we have focused on specific indications for lorundrostat. We may fail to generate additional clinical development opportunities for lorundrostat for a number of reasons, including the fact that lorundrostat in the indications we are pursuing or may be pursuing in the future may show adverse side effects in additional studies that limited to no efficacy, or other characteristics indicating that it is unlikely to receive marketing authorization and acceptance in such additional potential indications. Our resource allocation and other decisions may result in our failure to identify and exploit viable potential product candidates or additional indications for lorundrostat. Our current and future research and development program spending on new product candidates or additional leads on existing product candidates may not result in commercially viable product candidates or leads. If we do not accurately assess the commercial potential or target market for a particular product candidate or candidate, we may not be able to develop that product candidate or candidate or relinquish valuable rights in that product candidate through collaborations, licensing and other similar agreements if it were the case have been more advantageous to us than ideal to retain exclusive development and commercialization rights to such indications or product candidates, or to negotiate less favorable terms for such agreements.

In addition, we may pursue additional licenses or acquisitions of development-stage assets or programs, which pose additional risks to us. The identification, selection and acquisition of promising product candidates requires technical, financial and human know-how. Efforts to do so may not result in actual acquisition or licensing of a particular product candidate, potentially diverting our administrative time and consuming our resources without benefit. For example, if we are unable to identify programs that result in approved products, we may direct significant amounts of our capital and other resources to evaluating, sourcing and developing products that ultimately do not provide a return on our investment.

We intend to conduct some of our clinical trials for lorundrostat outside of the United States. However, the FDA and other foreign equivalents may not accept data from such tests, delaying our development plans and potentially causing significant damage to our business.

We intend to conduct one or more of our clinical trials for our lorundrostat product candidate outside of the United States. Acceptance of study data from clinical trials conducted outside the United States or other jurisdictions by the FDA or similar foreign regulatory agency may be subject to certain conditions or may not be accepted at all. In cases where foreign clinical trial data is intended to serve as the sole basis for marketing approval in the United States, the FDA generally will not approve the application based solely on foreign data unless (i) the data is US-based applicable. US Population and Medical Practice; (ii) the tests were performed by clinical investigators of recognized competence and in accordance with GCP regulations; and (iii) the data may be deemed valid without requiring an on-site inspection by FDA, or if FDA deems such inspection necessary, FDA may validate the data through on-site inspection or other appropriate means. Even if the data from foreign studies are not intended to serve as the sole basis for approval, the FDA will not accept the data in support of a marketing authorization application unless the study is well designed and well conducted according to GCP requirements. The FDA can Validate study data through an on-site inspection, if necessary. We are currently planning to conduct part of the future clinical program for lorundrostat in the European Union. While data from clinical trial sites in these countries does not serve as the sole basis for FDA approval, any foreign data that we use as part of an NDA submission is subject to previous FDA requirements and standards. Many foreign regulators have similar licensing requirements. There is no guarantee that the FDA or any comparable foreign regulatory agency will accept data from studies conducted outside of the United States or applicable jurisdiction. Failure by the FDA or similar foreign regulatory agency to accept such data would result in the need for additional testing, which can be expensive and time-consuming, and may result in current or future product candidates that we may develop not receiving approval for placing on the market in the relevant jurisdiction. . In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions in which the studies are being conducted, which may increase the cost or time required to complete the clinical study.

Conducting clinical trials outside of the United States also exposes us to additional risks, including risks related to:

•additional foreign regulatory requirements;

•currency fluctuations;

•Compliance with foreign manufacturing, customs, shipping and storage regulations;

•inconsistent standards for reporting and assessing clinical data and adverse events;

•COVID-19 or any other pandemic or future public health issue;

•reduced intellectual property protection in some countries; And

•political instability, civil unrest, war or similar events that could affect our ability to initiate, conduct or complete a clinical trial and evaluate the resulting data.

Interim, main and preliminary data from our clinical and pre-clinical studies that we announce or publish from time to time may change as more patient data becomes available and are subject to review and verification processes that result in material changes to the final data being able to lead.

From time to time, we may release interim, main or preliminary data from our clinical trials and preclinical studies based on a preliminary analysis of the data then available, and the results and associated findings and conclusions may change following a more comprehensive review of data related to the specific study or study. We also make assumptions, estimates, calculations and conclusions as part of our data analysis, and we may not have received all of the data or have not had an opportunity to fully and carefully evaluate all of the data. As a result, the interim, main, or preliminary results we report may differ from future results from the same studies or trials, or

different conclusions or considerations may put such results into perspective once additional data has been received and fully evaluated. Key and interim dates continue to be subject to testing and verification processes, which may result in final dates differing materially from interim or interim dates that we have previously released. Therefore, core and preliminary data should be viewed with caution until definitive data are available.

The preliminary clinical trial data that we are able to complete is still subject to the risk that one or more of the clinical outcomes could change materially as patient enrollment continues and more patient data becomes available. Unfavorable differences between interim, key or preliminary data and final data could materially affect our business prospects. In addition, the release of preliminary data by us or our competitors could cause the price of our common stock to fluctuate.

In addition, others, including regulators, may not accept or agree with our assumptions, estimates, calculations, conclusions or analysis, or may otherwise interpret or weigh the meaning of the data, which may affect the value, approval or marketing of the relevant program the specific product or candidate and our company in general. In addition, the information we publicly disclose about a particular study or clinical trial is typically large-scale and you or others may not agree with what we believe is appropriate material or information to be included in our disclosure and so on Information that we do not wish to disclose may be deemed material in connection with future decisions, conclusions, opinions, activities or otherwise relating to a particular drug, product candidate or our business. If the interim, key or preliminary data we report differs from actual results, or if others, including regulatory authorities, disagree with the conclusions drawn, our ability to receive approval and commercialize lorundrostat and any future product candidates could be affected , which could harm our business, results of operations, prospects or financial condition.

Changes in manufacturing methods or formulations of candidate products may result in additional costs or delays.

As product candidates progress from clinical trials to market and commercial approval, it is common for various aspects of the development program, such as manufacturing and formulation methods, to be modified over time to optimize safety, efficacy, throughput, and manufacturing batch size while minimizing costs and achieve consistent quality and results. For example, the manufacturing process used to produce clinical material for our planned clinical trials differs from that used in previous lorundrostat trials. There is no guarantee that such changes will achieve the intended goals. These changes, and any future changes we may make to lorundrostat or future product candidates, may also cause those candidates to behave differently and affect the results of future clinical trials conducted with the changed materials. Such changes or associated adverse clinical trial results may delay the initiation or completion of additional clinical trials, require interim studies or clinical trials to be conducted, or repeat one or more trials or clinical trials, increase development costs, delay or prevent potential market approval, and compromise our ability to commercialize and generate revenue for lorundrostat or any future product candidate, if approved.

Disruptions to the FDA and other government agencies caused by funding constraints or global health issues could affect their ability to hire, retain or deploy key executives and other personnel or prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could have a negative impact on our business.

The ability of the FDA and other government agencies to review and approve new products can be affected by a variety of factors, including state budgets and funding levels, legislative, regulatory and policy changes, a government agency's ability to hire and retain and accept staff payment of user fees and other events that may affect the government agency's ability to perform routine tasks. As a result, average review times at the FDA and other government agencies have fluctuated over the years. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions to the FDA and other agencies could also delay the time required for new drugs or changes to approved drugs to be reviewed and/or approved by the necessary government agencies, which would adversely affect our business. For example, the US government has shut down several times in recent years, and certain regulatory agencies, such as the FDA, have had to lay off key employees and halt key activities.

Separately, in response to the COVID-19 pandemic, the FDA has postponed most inspections of domestic and foreign manufacturing facilities at various locations. While the FDA has resumed standard home facility inspection operations where possible, the FDA has continued to monitor and implement changes to its inspection activities to ensure the safety of its employees and the businesses it regulates while adapting to the evolving environment, and any resurgence of the virus or emergence of new variants could cause further delays in inspections. Regulatory authorities outside of the United States may impose similar restrictions or other policy measures in response to the COVID-19 pandemic. If there is an extended government shutdown, or if global health concerns continue to prevent the FDA or other regulators from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the FDA's or other regulators' ability to review and process our regulatory submissions could have a material adverse effect on our business.

Risks related to our dependence on third parties

We rely heavily on our exclusive license with Mitsubishi Tanabe to provide us with intellectual property rights to develop and commercialize lorundrostat. If this license is terminated, we will lose our rights to develop and commercialize lorundrostat.

Pursuant to our license with Mitsubishi Tanabe (the Mitsubishi License), we have received, among other things, an exclusive license with royalties from Mitsubishi Tanabe under certain patents and know-how related to lorundrostat to commercialize lorundrostat worldwide for prevention, treatment and diagnosis , detection, monitoring or testing for predisposition in relation to indications, diseases and conditions in humans (the specialty). The Mitsubishi License will terminate country by country and product by product upon expiration of the applicable license term in respect of each product in each country, as applicable, or in its entirety upon expiration of the license term in respect of the last marketed product country, unless terminated earlier . We may revoke the Mitsubishi License in its entirety on a product-by-product or country-by-country basis, at our discretion, with (i) 90 days written notice to Mitsubishi Tanabe in respect of any country for which there is no license, terminate Regulatory Authority Approved Product and (ii) one hundred and eighty day written notice to Mitsubishi Tanabe in respect of each country for which a Regulatory Authority Approved Product exists. We and Mitsubishi Tanabe may terminate the Mitsubishi License upon the other party's bankruptcy or upon prior written notice within a specified period of time for the other party's unremedied material breach. Mitsubishi Tanabe may terminate the Mitsubishi license altogether if (i) we contest any licensed patents or assist a third party to contest such patents; or (ii) have not initiated regulatory consultations for the initial global clinical trials of lorundrostat in at least one major market country within a specified period of time. If regulatory milestones or other cash payments are due under the terms of the Mitsubishi License and we do not have sufficient funds to meet our obligations, Mitsubishi Tanabe has the right to terminate the Mitsubishi License in the event of unresolved failure. Mitsubishi Tanabe to pay. If Mitsubishi's license is terminated, we would lose our rights to develop and commercialize lorundrostat, which in turn would have a material adverse effect on our business, financial condition, results of operations and prospects, including without limitation the termination of our license to this extent we are unable to develop any further product candidates at the time of termination.

If, pursuant to the license agreement with Mitsubishi Tanabe, we decide to sublicense our rights under the Mitsubishi license to a third party in relation to the use of lorundrostat or any lorundrostat product in certain countries in Asia, we also agree to sublicense that sublicense first negotiate, for a specified period of time, with Mitsubishi Tanabe if Mitsubishi Tanabe notifies us that it wishes to acquire such a sublicense. We also agree not to market any competing product for a period of three years after the first commercial sale of the first Lorundrostat product in any country without Mitsubishi Tanabe's prior consent. If Mitsubishi Tanabe is interested in acquiring rights to any non-lorundrostat product or compound in the area that we may develop in the future, we have a good faith obligation to cooperate with Mitsubishi Tanabe for a period of to negotiate time to grant him a non-exclusive license with royalty payments under certain of our know-how and patents to use this product or compound on terms to be agreed upon by the parties in their sole discretion. Consequently, we may need to enter into collaborations with Mitsubishi Tanabe in the future, even if we prefer another counterparty for strategic or other reasons, we need to license some of our future product candidates (if any), even if we prefer to retain the use of that intellectual property and we cannot market competing products for a period of time, even if we believe there is a commercial advantage to doing so

Opportunity. For more information on the Mitsubishi license, see "Business - License Agreement with Mitsubishi Tanabe".

We have and intend to continue to rely on third parties to conduct, oversee and monitor our clinical trials and pre-clinical studies. If these third parties do not successfully fulfill their contractual obligations, meet applicable regulatory requirements, or meet the expected timeline, our development programs and our ability to apply for or receive regulatory approval for lorundrostat and any future product candidates, or to commercialize them, may be delayed or are subject to increased costs, each of which could adversely affect our business and prospects.

We rely on third parties to conduct our clinical trials and preclinical studies. In particular, we have and intend to continue to rely on medical institutions, clinical investigators, CROs and consultants to conduct pre-clinical studies and clinical trials, all in accordance with our clinical protocols and regulatory requirements. These CROs, investigators and other third parties play an important role in the conduct and timing of these studies and the subsequent data collection and analysis. While we hope to carefully manage our relationships with our CROs, investigators and other third parties, we cannot guarantee that we will not experience challenges or delays in the future or that such delays or challenges will not have a material adverse effect on our business or finances become state and prospects. In addition, while we have and do have contracts governing the activities of our third party contractors, we have only limited control over their actual performance. However, we have a responsibility to ensure that each of our clinical trials is conducted in accordance with applicable protocols and legal, regulatory and scientific standards and requirements, and our reliance on our CROs and other third parties does not relieve us of our responsibility. In addition, we and our CROs must comply with GLP and GCP requirements, which are regulations and guidelines used by the FDA and similar foreign regulatory agencies for lorundrostat and any future product candidates in clinical development. Regulatory agencies enforce these GCPs through regular inspections of study sponsors, principal investigators, and study sites. If we or any of our CROs or testing sites do not meet applicable GLP or GCP or other requirements, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or similar foreign regulatory agency may require us to perform additional clinical investigations Conduct testing before approving our marketing requests. For example, the conduct of the Phase 2 clinical trial of lorundrostat at one of our clinical sites was terminated by the IRB after we reported to the IRB a non-compliance with the GCP at that site, which we found during one of our routine clinical inspections. Additionally, our clinical trials must be conducted with products manufactured under cGMP regulations. Failure to comply with these regulations may result in us having to repeat clinical trials, which would delay the regulatory approval process.

There is no guarantee that any of our CROs, investigators or third parties will commit reasonable time and resources to such testing or study or act as contractually required. If any of these third parties fail to meet expected timelines, fail to comply with our clinical protocols or regulatory requirements, or otherwise behave substandard, our clinical trials may be extended, postponed or terminated. In addition, many of the third parties with whom we contract may also have relationships with other business entities, including our competitors, for whom they may also conduct clinical trials or other development activities that could harm our competitive position. In addition, the principal investigators of our clinical trials are expected to act as scientific advisers or consultants to us from time to time and may receive cash or stock compensation in connection with such services. If these relationships and related compensation create perceived or actual conflicts of interest, or if the FDA determines that the financial relationship may have affected the interpretation of the study, the integrity of the data generated at the particular clinical study site may into question and the usefulness of the clinical trial itself may be compromised, which may result in the FDA delaying or denying an NDA that we have submitted. Any delay or denial could prevent us from obtaining regulatory approval or commercializing lorundrostat and any future product candidates.

Our CROs have the right to terminate their contracts with us in the event of an unresolved material breach and in other specified circumstances. If any of our relationships with these third parties end, we may not be able to enter into agreements with alternative third parties on commercially reasonable terms, in a timely manner, or at all. Changing or adding additional CROs, investigators and other third parties involves additional costs and requires time and focus from our management. Also, there is a natural transition period when a new CRO starts work. As a result, delays are occurring that may significantly affect our ability to meet desired clinical development schedules. As we work to strengthen our relationships with our CROs, investigators and

Third parties, there are no guarantees that we will not experience challenges or delays in the future or that such delays or challenges will not have a material adverse effect on our business, financial condition or prospects.

We currently rely on third parties to manufacture lorundrostat for clinical development and expect to continue to rely on third parties for the foreseeable future. This dependence on third parties increases the risk that we may not have sufficient quantities of lorundrostat, or such quantities at an acceptable cost, which could delay, hamper or hinder our development or potential commercialization efforts.

We do not own or operate any manufacturing facilities and have no plans to develop our own clinical or commercial scale manufacturing capabilities. We rely on third parties for the manufacture of lorundrostat and related raw materials for clinical development and commercial manufacturing and expect to continue to rely on third parties when lorundrostat or a future product candidate receives marketing approval. Facilities used by third-party manufacturers to manufacture lorundrostat must be approved by the FDA and any equivalent foreign regulatory agency pursuant to inspections conducted after we provide the FDA with an NDA or equivalent foreign regulatory agency submission. We do not control the manufacturing process and are entirely dependent on third party manufacturers to comply with cGMP requirements for manufacturing products. If these third-party manufacturers cannot successfully manufacture materials that meet our specifications and the stringent regulatory requirements of the FDA or similar foreign regulator, they cannot secure and/or maintain regulatory approval for their manufacturing facilities. Additionally, we have no control over the ability of third party manufacturers to maintain adequate quality control, quality assurance, and qualified personnel. If the FDA or a similar foreign regulatory agency does not approve these facilities for the manufacture of lorundrostat, or withdraws an approval in the future, we may need to find alternative manufacturing facilities, which would materially impact our ability to develop, obtain, or commercialize lorundrostat, if so approved. Our failure or the failure of our third-party manufacturers to comply with applicable regulations may result in sanctions being imposed on us, including clinical suspensions, fines, injunctions, civil penalties, delays, suspension or revocation of approvals, seizures or recalls of lorundrostat or products, Operating restrictions and law enforcement that could materially and adversely affect the delivery of our products.

Failure by us or third parties to meet our manufacturing requirements on commercially reasonable terms, in a timely manner and in accordance with cGMP or other regulatory requirements could affect our business in a number of ways, including:

•an inability to initiate or continue clinical trials of lorundrostat or future product candidates;

•delays in receiving regulatory submissions or marketing approvals for lorundrostat or a future product candidate;

•subject third-party manufacturing facilities or our potential future manufacturing facilities to additional inspections by regulatory authorities;

•requests to discontinue development or recall lots of lorundrostat or future product candidates; And

•in the event of market approval and commercialization of lorundrostat or a future product candidate, failure to meet commercial demand for lorundrostat or a future product candidate.

In addition, we have no long-term commitments or supply contracts with third-party manufacturers. We may not be able to secure long-term supply agreements with third-party manufacturers or on acceptable terms, increasing the risk of not obtaining sufficient quantities of lorundrostat, or such quantities at acceptable costs. Although we have agreements with third-party manufacturers, dependence on third-party manufacturers poses additional risks, including:

•failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

•breach of the Manufacturing Agreement by a third party;

•failure to manufacture our product to our specifications;

•inability to obtain adequate raw materials and other materials needed for manufacture;

•failure to manufacture our product on our schedule or at all;

•failure to successfully increase production capacity when needed;

•Misuse of our proprietary information, including potential trade secrets and know-how; And

•Termination or non-renewal of the contract by the third party at a time that is costly or inconvenient for us.

Any non-performance by our existing or prospective manufacturers could delay clinical development or market approval, or affect our ability to initiate or continue commercialization of lorundrostat or any future product candidate, and any associated corrective actions may be expensive or time-consuming to implement. We currently have no provision for redundant supply or a second source for all necessary raw materials used in the manufacture of our candidate products. If our existing or prospective third party manufacturers are unable to function as agreed, we may need to replace those manufacturers and we may not be able to replace them in a timely manner or at all. Also, without additional suppliers of the necessary raw materials, we may not be able to meet the business needs of a commercial launch of a future product candidate.

In addition, our current and anticipated future reliance on third parties for the manufacture of lorundrostat and future product candidates could adversely affect our future profit margins and our ability to timely and competitively commercialize any products that receive regulatory approval.

Our reliance on third parties requires that we share potential trade secrets, which increases the likelihood that a competitor or other third party will discover them, or that potential trade secrets will be misused or disclosed.

Because we currently rely on third parties to manufacture lorundrostat and perform quality testing, we sometimes need to share our proprietary technology and confidential information, including potential trade secrets, with them. We seek to protect, in part, our proprietary technology by entering into confidentiality agreements and, where appropriate, material transfer agreements, research collaboration agreements, consulting agreements, or other similar agreements with our employees, directors, employees, and consultants before we begin research and disclosure of proprietary information. These agreements generally limit the rights of third parties to use or disclose our confidential information, including potential trade secrets. Despite contractual provisions when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets will become known to our competitors or other third parties, incorporated into third party technology, intentionally or accidentally, or disclosed or in violation of them agreements are used. Because our proprietary position is based in part on our know-how, and despite our best efforts to protect potential trade secrets, the discovery of our proprietary technology and confidential information by a competitor or other third party, or other unauthorized use or disclosure of such technology or information, could adversely affect our competitive position and could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may attempt to enter into collaborations, licensing agreements and other similar agreements and may not be successful in doing so, and even if we do, we could give up valuable rights and not realize the benefits of such relationships, and our collaborations would be subject to other risks that relationships with third parties, including the inability to prevent or control actions taken or not taken by such third parties that could adversely affect us.

We may attempt to enter into collaborations, joint ventures, licensing agreements and other similar arrangements for the development or commercialization of lorundrostat and future candidate products because of capital costs required to develop or commercialize the candidate product or because of manufacturing limitations. We may not be successful

in our efforts to establish or maintain such collaborations, as our research and development pipeline may be inadequate, lorundrostat or future product candidates may be considered too early in a development phase for a collaboration, or third parties may not believe that our product candidates have potential , which is necessary to demonstrate safety and efficacy or a significant commercial opportunity. In addition, we face significant competition in finding suitable strategic partners and the negotiation process can be time-consuming and complex. Even if we are successful in our efforts to establish such collaborations, the terms we agree to may not be favorable to us. For example, under such an agreement we may have to relinquish valuable rights in our future revenue streams, research programs, intellectual property or product candidates, or grant licenses on terms that may not be favorable to us, and such agreements may limit us from entering into additional agreements with other potential ones employees. Additionally, when we enter into such collaborations, we have limited control over the amount and time of resources our employees dedicate to developing or commercializing our product candidates. Our ability to generate revenue from these agreements depends on the ability of all prospective employees to successfully perform their assigned roles in these agreements. We cannot be certain that, following any collaboration, license or strategic transaction, we will achieve any economic benefit justifying such a transaction.

In addition, we may not be able to maintain such collaborations if, for example, development or approval of a product candidate is delayed, the safety of a product candidate is questioned, or sales of an approved product candidate are unsatisfactory.

Collaborations with lorundrostat or future product candidates would pose significant risks for us, including the following:

•Contributors have significant discretion in determining the effort and resources they will expend on these collaborations;

•Employees cannot meet their obligations as expected or at all;

•we may grant our employees exclusive rights that would prevent us from working with others;

•Contributors may not pursue the development and commercialization of candidate products that receive regulatory approval, or choose not to continue or renew development or commercialization programs based on clinical trial results, changes in staff strategic focus, available funding, or external factors , such as an acquisition that diverts resources or creates competing priorities;

•Associates may delay clinical trials, provide insufficient funding to a clinical trials program, halt a clinical trial or abandon a product candidate, repeat or re-run clinical trials, or request a new formulation of a product candidate for clinical testing;

•Employees may independently or with third parties develop products that compete directly or indirectly with our product candidates when employees believe that competing products are more likely to be successfully developed or commercialized on more commercially attractive terms than ours;

•Product candidates discovered in collaboration with us may be viewed by our employees as competing with their own product or drug candidates, which may result in employees committing resources to commercializing our product candidates;

•an employee with marketing and sales rights to a product candidate that receives regulatory approval may not devote sufficient resources to the marketing and sales of such products;

•an employee's sales and marketing activities or other operations may not comply with applicable laws, resulting in civil or criminal penalties;

•Disagreements with employees, including disagreements about ownership rights, contract interpretation, or preferred course of development, may result in delay or termination of the contract

Research, development or commercialization of Candidate Products could result in additional liability for us with respect to Candidate Products or result in litigation or arbitration, each of which would be time-consuming and costly;

•Employees cannot adequately enforce, maintain or defend our intellectual property rights or use our proprietary information or your information in a way that could result in litigation that could jeopardize or invalidate that intellectual property or proprietary information, or expose us to potential litigation ;

•Employees may infringe, misuse, or otherwise violate the intellectual property rights of others, which may expose us to litigation and potential liability;

•Employees may not provide us with timely and accurate information regarding the status or results of development, regulation or commercialization, which could affect our ability to manage our own development efforts, accurately predict financial results, or provide timely information to our shareholders about our licensed product candidates ;

•we may be required to invest resources and attention in such collaboration, which may distract from other business objectives;

•Disputes may arise between Contributors and us over ownership or other intellectual property rights that arise in the course of the collaboration;

•Collaboration agreements may not result in the development or commercialization of candidate products in the most efficient manner, or at all;

•If an employee of ours is involved in a business combination, further pursuit and emphasis of our product development or commercialization program may be delayed, reduced or terminated; And

•Collaborations may be terminated before or after the agreed term, including at the discretion of the employee, and termination may make it more difficult for us to enter into future collaborations or may require raising additional capital to continue development or commercialization of suitable product candidates.

Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to lorundrostat or future product candidates, could delay the development and commercialization of our product candidates and reduce their competitiveness when they reach the market, which could have material adverse effects have an impact on our business, our financial position, results of operations and prospects.

Risks associated with the commercialization of lorundrostat and future product candidates

Even if we receive regulatory approval for lorundrostat or a future product candidate, we are subject to ongoing regulatory obligations and ongoing regulatory reviews, which could result in significant additional costs. In addition, lorundrostat and any future product candidates, if approved, may be subject to labeling and other marketing or withdrawal restrictions, and we may be subject to penalties if we fail to meet regulatory requirements or if we have unforeseen issues with our candidate products, when and if one of them is allowed.

Any regulatory approvals we may receive for lorundrostat or future product candidates may require reporting to regulatory authorities, are subject to vigilance on our part to monitor product safety and efficacy, may have significant limitations in terms of age restrictions of use, warnings, precautions or contain contraindications and may involve costly post-approval studies or risk management requirements. For example, the FDA may require a risk assessment and mitigation strategy as a condition of approval of lorundrostat or any future product candidate, which may include requirements for a drug memorandum, plans for communicating with physicians, or additional elements to ensure safe use, such as: restricted distribution methods, patient registries and other risk reduction tools. If the FDA or similar foreign regulatory agency approves lorundrostat or a future product candidate, the manufacturing processes, labeling, packaging,

Distribution, adverse event reporting, storage, advertising, promotion, import, export and record keeping of our products are subject to extensive and ongoing regulatory requirements. These requirements include submission of safety and other post-marketing information and reporting, registration, and ongoing compliance with cGMP and cGCP requirements for all post-approval clinical trials we conduct. Manufacturers of approved products and their facilities are subject to ongoing review and periodic unannounced inspections by the FDA and other regulatory agencies for compliance and cGMP standards. Failure to comply with legal requirements or subsequent discovery of previously unknown issues with our products, including adverse events of unanticipated severity or frequency, or with our third party manufacturers or manufacturing processes, may result in, among other things:

•restrictions on the marketing or manufacture of our products, product withdrawals from the market, or voluntary or mandatory product recalls;

•restrictions on distribution or use of the product or requirements to conduct post-marketing studies or clinical trials;

•limitations on our ability to conduct clinical trials, including full or partial clinical suspensions in ongoing or planned trials;

•penalties, refunds, refunds of profits or proceeds, warning letters, unnamed letters, adverse publicity requirements, or clinical trial withholdings;

•refusal by the FDA or other regulatory authorities to approve pending applications or amendments to approved applications submitted by us, or suspension or revocation of approvals;

•confiscation or detention of any products or refusal to permit the import or export of our products; And

•Injunctions and imposition of civil or criminal penalties.

The occurrence of any of the events or penalties described above may affect our ability to commercialize and generate revenue for Lorundrostat or a future product candidate and may require us to invest significant time and resources to respond and generate negative publicity.

The guidelines of the FDA and other regulatory agencies may change, and additional government regulations may be issued that may prevent, limit or delay market approval of product candidates developed by us. We also cannot predict the likelihood, nature or extent of any governmental regulation that may result from any future law or administrative action, whether in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the introduction of new requirements or policies, or if we are unable to maintain regulatory compliance, we may be subject to enforcement action and may not achieve profitability or maintain.

The FDA and other regulatory agencies actively enforce laws and regulations prohibiting the promotion of off-label uses.

The FDA and other regulatory agencies strictly regulate the advertising claims that can be made about prescription products like lorundrostat or future product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or other regulatory agency, as indicated in the approved product labeling. If we get marketing approval for lorundrostat, or a future product candidate, doctors may prescribe it to their patients in a way that doesn't match the approved label. If we are found to be promoting such off-label uses, we could be subject to significant liability. The US federal government has imposed substantial civil and criminal fines on companies alleged to have inappropriately advertised off-label use, and has banned several companies from engaging in off-label advertising. The government has also required companies to enter into consent ordinances or permanent injunctions that modify or restrict certain advertising efforts. If we are unable to successfully manage the promotion of lorundrostat or any future product candidates, we could be subject to significant liability, which would adversely affect our business and financial condition.

The commercial success of lorundrostat or future product candidates depends on the level of market acceptance of such product candidates by healthcare providers, product recipients, healthcare payers and others in the medical community. If lorundrostat or a future product candidate does not achieve the broad level of acceptance in the medical community required for commercial success, our results of operations and financial condition will be adversely affected, which could delay, hinder or limit our ability to generate revenue and continue our business.

Lorundrostat and any future product candidates may not be commercially successful. Even if lorundrostat or future product candidates receive regulatory approval, they may not gain market acceptance from healthcare professionals, individuals in our target audience, healthcare payers, or the medical community. The commercial success of lorundrostat, or any future product candidate, will depend largely on the widespread adoption and use of the resulting product by these individuals and organizations for approved indications. The level of market acceptance of our products depends on a number of factors, including:

•Proof of clinical effectiveness and safety, also in comparison to more established products;

•the indications for which our product candidates are approved;

•the limitation of our target patient population and other limitations or warnings contained in any FDA-approved label;

•acceptance of a new drug for the appropriate indication by healthcare professionals and their patients;

•the price and economics of our products and the cost of treatment with our products compared to alternative treatments and therapies;

•our ability to obtain and maintain adequate third-party coverage and appropriate reimbursement from government healthcare programs, including Medicare and Medicaid, private health insurers and other third-party payers;

•the willingness of patients to bear all or part of the direct costs associated with our products in the absence of adequate third-party coverage and adequate reimbursement;

•any restrictions on the use of our products and the prevalence and severity of side effects;

•potential product liability claims;

•the timing of our products' launch and the availability, safety and effectiveness of competing medicines;

•the effectiveness of our sales and marketing strategies to prospective or potential employees; And

•unfavorable advertising for the product.

If lorundrostat or a future product candidate is approved but does not achieve adequate acceptance by physicians, hospitals, payers or patients, we may not generate sufficient revenue from that product and become or remain profitable. Our efforts to educate the medical community and third-party payers about the benefits of our products may require significant resources and may never be successful.

Successful commercialization of lorundrostat, or a future product candidate if approved, will depend in part on the extent to which government agencies and health insurers establish coverage, appropriate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain adequate coverage and reimbursement for our products may limit our ability to market those products and reduce our ability to generate revenue.

The availability of coverage and appropriate reimbursement from government healthcare programs such as Medicare and Medicaid, private health insurers, and other third-party payers is essential for most patients to be able to afford prescription drugs such as lorundrostat and any future product candidates. if approved. Our

The ability to obtain coverage and acceptable reimbursement rates for our products from third-party payers will affect our ability to successfully market those products. Therefore, we must successfully implement a coverage and reimbursement strategy for all approved product candidates. Even if we receive coverage for a particular product through a third-party payer, the resulting reimbursement rates may not be reasonable or require co-payments that patients find unacceptably high.

When we participate in the Medicaid Drug Rebate Program or other government pricing programs, under certain circumstances our products are subject to price caps set by those programs, which may reduce the revenue we can earn from those products. Participation in such programs would also expose us to significant civil penalties, penalties and penalties for breaching applicable obligations.

Products administered under medical supervision can be particularly difficult to obtain adequate coverage and reimbursement due to the higher prices generally associated with these drugs. In addition, separate reimbursement may not be available for the product itself or for the treatment or procedure in which the product is used, which may impact physician use. We cannot be certain that coverage and reimbursement will be available or to an acceptable level in the United States, European Union, or elsewhere for any product we develop, and any reimbursement that may be provided may be in the United States, the European Union or elsewhere may be reduced or eliminated in the future. Future.

Third-party payers are increasingly challenging the pricing of biopharmaceutical products and services, and many third-party payers may refuse coverage and reimbursement for certain drugs when an equivalent generic or cheaper therapy is available. It is possible for a third party payer to consider our products interchangeable and only reimburse patients for the cheaper product. Even if we are able to demonstrate greater efficacy or easier administration with our products, the price of existing medications may limit the amount we can charge for our products. These payers may refuse or revoke refund status for a particular product, or may price new or existing marketed products at levels too low to allow us to receive a reasonable return on our product development investments. If cashback is unavailable or has limited availability, we may not be able to successfully market our products and we may not be able to earn a satisfactory financial return on the products we develop.

There is significant uncertainty surrounding third-party payer coverage and reimbursement for newly approved products. In the United States, third-party payers, including private and government payers such as Medicare and Medicaid, play an important role in determining the extent to which new drugs are covered. Some third-party payers may require pre-approval of coverage for new or innovative devices or drug therapies before reimbursing healthcare providers who use such therapies. At this time, it is difficult to predict how third-party payers will make decisions regarding coverage and reimbursement for lorundrostat and future product candidates.

Obtaining and maintaining reimbursement status is time consuming, expensive and uncertain. Medicare and Medicaid programs are increasingly being used as models for how private payers and other government payers develop their drug coverage and reimbursement policies. However, there is no consistent product coverage and refund policy among third-party payers in the United States. As such, product coverage and reimbursement can vary significantly from payer to payer. Because of this, determining coverage is often a time-consuming and expensive process that requires us to provide scientific and clinical support for the use of our products to each payer separately, with no guarantee that appropriate coverage and reimbursement will be applied consistently or received in the first instance. In addition, refund rules and regulations change frequently, sometimes at short notice, and we believe changes to these rules and regulations are likely.

Outside of the United States, international businesses are generally subject to extensive government price controls and other market regulations, and we believe that the increasing emphasis on cost containment initiatives in Europe and elsewhere has pressured and will continue to pressure the price and use of our candidate products if in permitted in these jurisdictions. In many countries, the prices of medical devices are subject to price fluctuations.

Control mechanisms as part of national health systems. In other countries, companies can set their own prices for medicinal products but monitor and control the company's profits. Additional foreign price controls or other changes in pricing regulations may limit the amount we can charge for our products. As a result, in markets outside of the United States, refunds on our products may be reduced compared to the United States and may not be sufficient to generate commercially reasonable revenue and profits.

In addition, increasing efforts by federal and external payers in the United States and abroad to limit or reduce health care costs may result in these organizations limiting coverage and reimbursement levels for newly approved products and therefore may not provide coverage or make reasonable payment for our products. Due to the managed care trend, the growing influence of healthcare organizations and additional legislative changes, we anticipate price pressure related to the sale of our products. The downward pressure on health care costs in general and on prescription drugs, surgery and other treatments in particular has become very strong. As a result, ever higher market entry barriers for new products are being erected.

We face significant competition, and when our competitors develop and commercialize technologies or product candidates faster than we can, or when their technologies or product candidates are more potent, safer, or less expensive than lorundrostat and any future product candidates they develop, our business and ability to Developing and marketing products successfully is impaired.

The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing or may develop products, product candidates and processes that compete with lorundrostat. Lorundrostat and any future product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. Our competitors include larger and better funded pharmaceutical, biopharmaceutical, biotechnology and therapeutic companies. In addition, we may also compete with universities and other research institutions that may be conducting research in our target indications and are in direct competition with us. We also compete with these organizations for hiring managers, scientists and clinical development personnel, and our inability to compete successfully could affect our expertise and ability to execute our business plan. We will also compete in establishing clinical trial sites, registering clinical trial individuals and identifying and licensing intellectual property related to new product candidates, as well as entering into collaborations, joint ventures, licensing agreements and other similar agreements . Smaller or young companies can also become important competitors, especially through cooperation agreements with large, established companies.

We believe that our current and future competition for resources and ultimately customers can be divided into three broad categories:

•companies developing aldosterone synthase inhibitors including Boehringer Ingelheim, CinCor, Damian Pharma and PhaseBio;

•companies with product candidates with different mechanisms of action, including Idorsia, Quantum Genomics, IONIS, Alnylam, Sihuan Pharmaceutical Holdings Group and KBP BioSciences; And

•Companies that market commodity antihypertensives such as ACE inhibitors, ARBs, thiazide diuretics and calcium channel blockers, many of which are available generically at very low prices, including AstraZeneca, Johnson & Johnson, Merck, Novartis and Pfizer.

Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and procurement resources or experience than we do. If we receive approval for lorundrostat, or any future product candidate, we will face competition based on many different factors, including the safety and effectiveness of our products, the ease with which our products can be administered, the timing and scope of the Regulatory requirements for these products, availability and manufacturing costs, marketing and distribution opportunities, pricing, reimbursement coverage, and patent status. Competing products may offer superior treatment alternatives because they are marketed and sold more effectively, safely, conveniently, cost-effectively, or efficiently than any products we may develop. Competing products may render lorundrostat or future product candidates we are developing obsolete or

are not competitive before we recover the cost of developing and commercializing our product candidates. If we are unable to compete effectively, our ability to generate revenue from sales of our products, which we may develop if approved, could be impacted.

We do not currently have a marketing and sales organization or experience as a business marketing products, and we may need to invest significant resources to develop these skills. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product sales.

We have no internal sales, marketing or distribution capabilities, nor do we market any product. If lorundrostat or any future product candidate receives regulatory approval, we will need to build a marketing and sales organization with the technical expertise and supporting sales resources to commercialize each of these products in key markets, which will be expensive and time consuming, or work with third parties to do that we have established direct sales and distribution systems, either to augment our own sales force and distribution systems or in place of our own sales force and distribution systems. As a company, we have no experience in the marketing, sale or distribution of biopharmaceuticals, and building and managing a sales organization involves significant risks, including our ability to hire, retain and develop qualified individuals, generate sufficient sales contacts and appropriate training provide sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of these products. We may not be able to enter into partnerships or hire outside consultants or service providers to assist us with sales, marketing and distribution functions on acceptable financial terms or at all. In addition, our revenue from products and our profitability, if any, may be less when we rely on third parties for these functions than when we market, sell and distribute products that we develop ourselves. We are likely to have little control over these third parties, and one of them may fail to devote the resources and attention necessary to effectively sell and market our products. If we are not successful in marketing our products, either alone or through arrangements with one or more third parties, we may not be able to generate future product sales and may incur significant additional losses.

If the market opportunity for lorundrostat and future product candidates is less than we believe, our revenues could be adversely affected and our business could suffer.

The exact incidence and prevalence of all diseases that we plan to address with lorundrostat or a future product candidate is unknown. Our projections of the number of people with these conditions, and the subset of people with these conditions who may benefit from treatment with our candidate products, are based on various internal and third-party estimates. These estimates come from a variety of sources, including academic literature, clinical surveys, patient foundations or market research, and may prove to be incorrect. In addition, new studies may change the estimated incidence or prevalence of these indications. Although we believe our assumptions and data on which our estimates are based are reasonable, we have not independently verified the accuracy of the third-party data on which we base our assumptions and estimates, and such assumptions and estimates may not be accurate and the conditions that support them Our assumptions or estimates are subject to change at any time, including as a result of factors beyond our control, which reduce the predictive accuracy of those underlying factors. The overall addressable market across all potential indications for lorundrostat and any future product candidates will ultimately depend on, among other things, the diagnostic criteria included on the final label for each product candidate that receives marketing approval for those indications, the availability of alternative treatments, and safety , convenience, cost and effectiveness of such candidate products in relation to such alternative treatments, acceptance by the medical community and patient access, pricing and reimbursement of drugs. Patient enrollments in the United States and other major markets and elsewhere may be lower than anticipated, patients may not be accessible for treatment with our product candidates, or it may become increasingly difficult to identify or access new patients, all of which may have an adverse impact would our business, financial and earnings position.

Our future growth may depend in part on our ability to operate in foreign markets where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future growth may depend in part on our ability to develop and commercialize lorundrostat and any future product candidates in foreign markets. We are not permitted to market or promote any candidate product until we have received regulatory approvals from the appropriate regulatory authorities in foreign markets, and we may never receive such regulatory approvals for lorundrostat or any future product candidate. In order to receive separate regulatory approval in many other countries, we must meet various and varied regulatory requirements related to safety and efficacy, including managing clinical trials, commercial sales, pricing and distribution of lorundrostat and any future product candidates. Approval processes can be more cumbersome than in the United States and may require additional preclinical studies or clinical trials to be conducted. As we receive regulatory approvals for candidate products and ultimately commercialize our products in foreign markets, we will face additional risks and uncertainties, including:

•different regulatory requirements for drug approvals abroad;

•limited protection of intellectual property rights;

•the existence of additional third-party patent rights that may be relevant to our business;

•unexpected changes in tariffs, trade barriers and regulatory requirements;

•economic weakness, including inflation, or political instability in certain foreign economies and markets;

•compliance with export and import control laws and regulations;

•Compliance with tax, labor, immigration and employment laws for employees who live or travel abroad;

•Fluctuations in currency exchange rates, which may result in increased operating costs and reduced revenues, and other obligations arising from doing business in another country;

•foreign refunds, prices and insurance regulations;

•worker insecurity in countries where labor unrest is common;

•different regulatory requirements for manufacturing products;

•production bottlenecks due to events affecting the supply of raw materials or production capacities abroad;

•business disruptions due to geopolitical events, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires; And

•Disruptions due to the impact of public health pandemics or epidemics (including, for example, the current COVID-19 pandemic).

Risks related to our business and our sector

Our results of operations can vary significantly, which makes it difficult to predict our future results of operations and could cause our results of operations to fall short of expectations or our projections.

Our quarterly and annual results of operations can vary significantly, making it difficult for us to predict our future results of operations. These fluctuations can occur due to a variety of factors, many of which are beyond our control, including but not limited to:

•the timing, cost and level of investment in research, development, regulatory approval and commercialization activities related to lorundrostat or future product candidates, from time to time;

•timing and success or failure of preclinical or clinical trials for lorundrostat or future product candidates or competing product candidates or other changes in the competitive landscape of our industry, including consolidation among our competitors or partners;

•coverage and reimbursement policies related to lorundrostat or future product candidates, if approved, and possible future drugs that compete with our products;

•expenses we may incur to acquire, develop or commercialize additional products and technologies;

•the level of demand for approved products, which can vary significantly;

•future accounting pronouncements or changes in our accounting policies;

•the duration and amount of any milestones, royalties or other payments due from us or us under any collaborative, licensing or other similar agreements; And

•Changes in general market and economic conditions.

The cumulative effects of these factors could cause our quarterly and annual results of operations to be highly volatile and unpredictable. Therefore, a comparison of our results of operations from period to period may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

Such fluctuations and unpredictability may also mean that we are unable to meet the expectations of industry or financial analysts or investors at any given time. If our revenues or results of operations fall below analysts' or investors' expectations or below any forecasts we provide to the market, or when any forecasts we provide to the market fall below analysts' or investors' expectations, the price of our Common stocks decline decline. This share price decline may occur even if we have not achieved any of the foregoing income or earnings projections that we may make.

We depend on the services of our management and other clinical and scientific staff, and if we are unable to retain these individuals or recruit additional management or clinical and scientific staff, our business will suffer.

Our success depends in part on our continued ability to attract, retain and motivate high quality administrative, clinical and scientific staff. We are highly dependent on our senior management, as well as our senior scientists and other members of our management team. The loss of services by any of these individuals could delay or prevent the successful development of lorundrostat or any future product candidate, the initiation or completion of our clinical and preclinical studies, regulatory approvals, or the commercialization of lorundrostat or any of our product candidates. Although we have signed employment contracts with every member of our senior management team, these contracts are subject to termination at our discretion with or without notice and as a result we may not be able to maintain your services as expected. We do not currently have "key person" life insurance for our officers or any of our employees. This lack of insurance means we may not have adequate compensation for the loss of the services of these people.

Additionally, job seekers and existing employees often consider the value of stock awards they receive in connection with their employment. If the perceived benefits of our stock awards diminish, whether because we are a public company or for other reasons, it could affect our ability to hire and retain highly qualified employees. Our employees are more likely to leave us when their stock has increased significantly compared to the original purchase prices for the stock, or when the exercise prices of options they hold are significantly below the market price of our common stock, particularly after the expiration of the lock described herein -up agreements.

We must expand and effectively manage our managerial, operational, financial and other resources to successfully continue our clinical development and commercialization efforts. Due to intense competition for qualified personnel among biopharmaceutical, biotechnology and other companies, we may not be able to sustain our unique corporate culture and continue to attract or retain qualified management, scientific and clinical personnel. Our industry has experienced a high turnover rate of administrative staff in recent years. If we are unable to attract, onboard, retain and motivate the people needed to achieve our business goals, we could face limitations that limit our ability to achieve our development goals, our ability to raise additional capital, and our ability to execute our strategy will be materially adverse to business .

We will need to continue to develop and expand our organization and we may find it difficult to successfully manage our growth and expand our operations, which could disrupt our operations.

As of December 15, 2022, we have 12 full-time employees, eight of whom are mainly involved in research and development. As we continue development and pursue the potential commercialization of lorundrostat and future product candidates and the transition to public company operations, we need to expand our finance, accounting, development, regulatory, manufacturing, information technology, marketing and sales functions or contract with third parties to accommodate us provide these functions. As our business expands, we anticipate that we will need to maintain additional relationships with various strategic partners, suppliers and other third parties, and we may not be successful in doing so. Our future financial performance and our ability to develop and commercialize lorundrostat and any future product candidates and compete effectively will depend in part on our ability to effectively manage future growth.

We are subject to various US federal, state and foreign health care laws and regulations that may increase compliance costs, and our failure to comply with these laws and regulations could adversely affect our results of operations and financial condition.

Our current and future operations and agreements with investigators, healthcare professionals, consultants, third-party payers, patient organizations and customers expose us to extensive foreign, state and federal fraud and abuse and other healthcare laws and regulations. These laws may restrict the business or financial arrangements and relationships through which we conduct our business, including how we research, market, sell and distribute products for which we receive regulatory approvals. These laws include:

•the federal Anti-Bribery Act, which prohibits, among other things, any person or entity from knowingly and voluntarily soliciting, offering, receiving, or giving compensation (including kickbacks, bribes, or certain rebates), directly or indirectly, openly or secretly, in exchange for cash or anything in kind for the recommendation of any person or the purchase, lease or order, agreement or recommendation to purchase, lease or order any goods, facilities, items or services for which payment may be made in whole or in part under a government healthcare program such as Medicare and Medicaid. An individual or entity need not have actual knowledge of, or a specific intent to violate, the federal anti-kickback statute in order to commit a violation;

•Federal false claims laws, including the Civil False Claims Act, and civil penalties laws, which prohibit, among other things, any individual or entity from knowingly submitting, or having submitted to the federal government, any payment or authorization claim, false or fraudulent, knowingly making, using or making or causing to be used, make or cause a false registration or material claim for a false or fraudulent claim, or knowingly make or cause a false claim to avoid, mitigate or disguise an obligation to pay any money to the federal government. Also the government

allege that a claim, including for any item or service, arising out of a violation of the federal anti-bribery statute constitutes a false or fraudulent claim under the Civil False Claims Act;

•the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prescribes criminal and civil liability for, among other things, knowingly and intentionally executing or attempting to execute a program to defraud a health benefits program or knowingly and intentionally misrepresenting it. conceal or cover up any material fact or make a material misstatement in connection with the provision or payment of any benefit, healthcare or service. Similar to the federal anti-kickback law, a person or entity need not have actual knowledge of the law or a specific intent to violate it in order to commit a violation;

•the state Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics, and medical supplies eligible for payment under Medicare, Medicaid, or the Children's Health Insurance Program (with certain exceptions) to pay the Centers for Medicare to report annually & Medicaid Services (CMS), information on payments and other “transfers of value” to physicians (defined as physicians, dentists, optometrists, podiatrists and chiropractors), certain non-medical professionals (physician assistants, nurses, clinical nurse). practitioners, anesthesiologists, anesthesiology assistants and midwives) and teaching hospitals and other healthcare providers, and interests and equity interests held by such healthcare professionals and their immediate family members; And

•analogous federal and foreign laws and regulations, such as B. State anti-kickback and false claims laws that may apply to sales or marketing agreements and claims related to healthcare items or services reimbursed by non-state third-party payers, including private insurers; Certain state laws require biotechnology companies to comply with voluntary biotechnology industry compliance guidelines and relevant federal government compliance guidelines, and may require drug manufacturers to report information about payments and other transfers of value to physicians and other healthcare or marketing expenses; certain state laws that require biotechnology companies to provide information about the price of certain drugs; and certain state and local laws requiring registration or pharmaceutical sales representatives.

Efforts to ensure that our current and future business relationships with third parties comply with applicable health and privacy laws and regulations will have significant ongoing costs. Government authorities may determine that our business practices may not comply with current or future laws, regulations or jurisprudence relating to fraud and abuse or other healthcare laws and regulations. If our operations violate any of these laws or other governmental regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, restitution, imprisonment, disqualification from participation government healthcare programs -funded expenditures such as Medicare and Medicaid, integrity oversight and reporting requirements, contractual damages, reputational damage, reduced profits and future revenues, and downsizing or restructuring of our operations. Defending against such actions can be costly, time-consuming and require significant financial and human resources. Therefore, even if we can successfully defend ourselves against such claims made against us, our business could be harmed. In addition, if any of the physicians or other healthcare providers or entities with whom we anticipate doing business fail to comply with applicable laws or regulations, they may be subject to significant criminal, civil or administrative penalties, including disqualification from sponsored healthcare.

Recent legislation, future legislation and healthcare reform policies may increase the difficulty and cost for us to obtain regulatory approval and commercialize lorundrostat and any future product candidates and may affect the prices we may set.

In the United States and certain foreign jurisdictions, there have been, and we expect to continue to be, a number of legislative and regulatory changes in the healthcare system, including cost-containment measures that reduce or limit coverage and reimbursement for newly admitted patients can affect drugs and affect our ability to profitably sell product candidates for which we have received marketing approval. In particular, they existed and continue to exist

At the federal and state levels in the United States, there are a number of initiatives aimed at reducing healthcare costs and improving the quality of healthcare.

For example, in March 2010, the ACA was enacted in the United States. The ACA has established a non-deductible annual fee for any company that manufactures or imports branded prescription drugs and biologics; expanded Medicaid reimbursement responsibility of manufacturers for Covered Drugs dispensed to individuals enrolled in Medicaid managed care organizations; expanded eligibility criteria for Medicaid programs; advanced units eligible for 340B drug pricing program discounts; increasing the statutory minimum rebates that a manufacturer must pay under the Medicaid Drug Rebate Program; Establishing and funding a new patient-centred outcomes research institute to monitor, prioritize and conduct comparative clinical efficacy research; and establishes a Center for Medicare & Medicaid Innovation at CMS to test innovative payment and service delivery models to reduce Medicare and Medicaid spending.

Since its passage, certain aspects of the ACA have been challenged by the executive branch, the judiciary, and Congress, and on June 17, 2021, the U.S. Supreme Court dismissed the most recent court challenge to the ACA filed by several states without specifically addressing the Constitutionality to decide .by the Court of Auditors. Prior to the Supreme Court ruling, President Biden issued an executive order to begin a special enrollment period from February 15, 2021 through August 15, 2021 to receive health insurance coverage through the ACA marketplace. The executive order also directed certain government agencies to review and reconsider their existing policies and rules that restrict access to health care, including but not limited to reviewing Medicaid demonstration projects and waiver programs that include labor requirements and policies that are unnecessary Barriers create access to Medicaid or ACA health coverage. It is unclear how the healthcare reform measures will affect our business.

In addition, further legislative changes have been proposed and passed since the Court of Auditors came into force. On March 11, 2021, the American Rescue Plan Act of 2021 was enacted, removing the statutory cap on the Medicaid drug rebate, which is currently set at 100% of a drug's AMP, effective January 1, 2021. 2024. In addition, with the cost of prescription drugs rising, the government in the United States has increased scrutiny over drug pricing practices. Such scrutiny has led to several recent congressional investigations and proposed and enacted federal and state legislation aimed, among other things, at making product pricing more transparent, reviewing the relationship between pricing and manufacturers' patient care programs, and reimbursement from government programs for products to reform. More recently, the Inflation Reduction Act of 2022, or IRA, encompassed a number of significant drug pricing reforms, including the establishment of a drug price negotiation program at the U.S. Department of Health and Human Services, or HHS (beginning in 2026), requiring manufacturers to negotiate a "maximum fair price." ' on certain select drugs or pay an excise tax for non-compliance, set requirements for rebate payments to manufacturers under Medicare Parts B and D to penalize price increases that exceed inflation (first due in 2023), and a redesign of the Part D benefit, under which manufacturers are required to offer discounts on Part D drugs (from 2025). The IRA allows the HHS registrar to implement many of these provisions through guidance rather than regulation in the early years. Further price proposals for medicines may be included in future legislation. In addition, it is possible that additional government measures will be taken in response to the COVID-19 pandemic.

At the state level, legislators have increasingly enacted laws and regulations to control drug and biologics prices, including price or reimbursement restrictions, rebates, restrictions on access to certain products, and disclosure of marketing costs and safety measures. in some cases to encourage imports from other countries and bulk purchases. Statutory price controls on third-party payment amounts or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional health authorities and individual hospitals are increasingly using competitive bidding processes to determine which drugs and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce ultimate demand for lorundrostat and any future product candidates, if approved, or depress the price of our products, which could adversely affect our business, results of operations, financial condition and prospects.

It is our hope that these new laws and other healthcare reform measures that may be passed in the future may result in additional cuts in Medicare and other healthcare funding, tighter coverage criteria, and new ones

Payment methods and additional downward pressure on the price we receive for eligible products. Any reduction in reimbursement from Medicare or other government programs could result in a similar reduction in payments for private payers. The implementation of cost containment measures or other healthcare reforms could prevent us from generating revenue, becoming profitable or commercializing lorundrostat and any future product candidates, if approved.

If product liability proceedings are instituted against us, we may incur significant liability and may be forced to restrict, delay or stop marketing our products.

As a result of the clinical trials of lorundrostat and future product candidates, we face an inherent risk of product liability, and we will face an even greater risk if we commercialize our product candidates, particularly if our products are prescribed for off-label uses (even if we do not encourage such uses). For example, we may be prosecuted if our product candidates are said to cause injury or are found to be inappropriate in the testing, manufacturing, marketing or sale of the product. Any product liability claims may include claims for manufacturing defects, design defects, failure to warn of inherent hazards of the Candidate Product, negligence, strict liability, and breach of warranties. Complaints may be brought against us by clinical trial participants, patients or others who use, administer or sell products that may be approved in the future. Claims can also be asserted under state consumer protection laws.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liability or be forced to limit, delay, or stop marketing our products. Even a successful defense would require significant financial and administrative resources. Regardless of the merit or possible outcome, liability claims may result in:

•decreased demand for our products;

•damage to our reputation and significant negative media attention;

•exclusion of participants from clinical trials;

•costs of defending related litigation;

•a distraction of our administration's time and resources;

•significant cash prizes for test takers or product recipients;

•product recalls, recalls, or labeling, marketing, or promotional restrictions;

•significant adverse financial impact;

•the inability to commercialize lorundrostat or any future product candidate; And

•a decline in our share price.

We currently have approximately $10.0 million in total product liability insurance. We may need to increase our coverage as we expand our clinical trials or as we begin commercializing lorundrostat or a future product candidate. Insurance protection is becoming more and more expensive. Our inability to obtain and maintain adequate product liability insurance at a reasonable cost to protect against potential product liability claims may prevent or hinder the commercialization of lorundrostat or any future product candidate. Although we maintain such insurance, any claim brought against us may result in a court judgment or settlement for an amount not covered in whole or in part by our insurance or in excess of the limits of our coverage. Our insurance policies also have various exclusions and we may be subject to a product liability claim for which we have no cover. We may be required to pay amounts awarded or settled by a court that exceed our coverage limits or are not covered by our insurance, and we may not have or be unable to raise sufficient funds to pay such amounts.

Our insurance policies are expensive and only protect us against certain business risks that expose us to significant uninsured liabilities.

We do not have insurance for every category of risk that our business may be exposed to. Some of the policies we currently maintain include property, general liability, social security liability, commercial motor vehicle, workers compensation, product liability, malicious intrusion into our electronic systems and directors' and officers' insurance, and labor practices. However, we do not know if we can maintain the insurance with sufficient coverage. There can be no guarantee that an insurer will not attempt to cancel or refuse coverage after a claim has arisen. Any significant uninsured liability could require us to pay substantial amounts, which could adversely affect our financial condition and results of operations.

We and all of our prospective future employees have an obligation to report to regulatory authorities if any of our approved products causes or contributes to an adverse medical event and any failure to do so would result in sanctions that would cause significant harm to our business.

If we or any of our potential future employees are successful in marketing our products, the FDA and foreign regulatory authorities will require us and those employees to report certain information about adverse medical events when those products may have caused or contributed to those adverse events . The timing of our reporting obligation would trigger the date we learn about the adverse event and the nature of the event. We and any of our potential future contributors or CROs cannot report adverse events within the prescribed timeframe. If we or any of our prospective future employees or CROs fail to comply with these reporting requirements, the FDA or a foreign regulatory agency may take action, including criminal prosecution, imposition of civil penalties, seizure of our products, or delay in the approval or release of future products.

We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations that may increase compliance costs, and our actual or perceived failure to comply with those laws and obligations may subject us to liability, fines or penalties and harm our business.

We and our service providers maintain and maintain much confidential information, including confidential business and patient health information, in connection with our pre-clinical studies and clinical trials, and are subject to laws and regulations that govern the privacy and security of such information. The global data protection landscape is evolving rapidly, and we and our service providers may be affected or subject to new, amended or existing laws and regulations in the future, even as our business continues to expand or when we operate in foreign jurisdictions. These laws and regulations can be interpreted in different ways, which increases the complexity of the processing of personal data. Guidelines on implementation practices and compliance are frequently updated or revised. This may create uncertainties in our business, affect our ability to operate in certain jurisdictions or otherwise collect, store, transfer, use, share and process personal information, require acceptance of more onerous obligations in our contracts , give rise to liability or impose costs on us . The cost of complying with these laws, regulations and standards is high and likely to increase in the future. Any perceived failure or omission by us to comply with any federal, state or foreign law or regulation, our internal policies and procedures, or our contracts governing our processing of personal information may result in negative publicity, governmental investigations and enforcement actions by third parties, claims for damages, and reputational damage that could have a material adverse effect on our business, financial condition, results of operations and prospects.

As our operations and business grow, we may be subject to or affected by new or additional data protection laws and regulations and may face increased scrutiny or attention from regulatory authorities. In the United States, various federal and state laws and regulations, including health privacy laws, data breach notification laws, and consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), govern the collection, use, storage, transfer, disclosure, Protection and other processing of health-related information and other personal data may relate to our operations or the operations of our employees and third parties. In addition, we may receive health information from third parties (including research organizations from which we receive clinical trial data) that are subject to HIPAA privacy and security requirements. Depending on the facts and circumstances, we could face significant penalties for violating HIPAA.

In addition, certain state laws govern the privacy and security of personally identifiable and health-related information in certain circumstances, some of which may be stricter, broader, or provide greater individual rights with respect to protected health information than HIPAA, many of which may differ from one another, thereby Compliance efforts become more difficult. These laws are evolving rapidly and can differ significantly from one another and may not have the same effect, complicating compliance efforts. Such laws and regulations are subject to interpretation by various courts and other governmental agencies, creating potentially complex compliance issues for us and our prospective customers and strategic partners. Failure to comply with these laws may result in the imposition of significant civil and/or criminal penalties and private litigation. For example, the California Consumer Privacy Act (CCPA), which went into effect on January 1, 2020, gives California residents individual privacy rights to access and delete their personal information, opt-out of the sharing of certain personal information, and receive detailed information about, how your personal data is used. The CCPA provides civil penalties for violations, as well as a private right of action for data breaches that are expected to result in data breach litigation. The CCPA can increase our compliance costs and potential liability, and many similar laws have been proposed at the federal and state levels. In addition, the California Privacy Rights Act (CPRA) was recently passed in California. The CPRA will impose additional data protection obligations on affected companies, including additional consumer rights processes, limitations on data use, new audit requirements for high-risk data, and disabling certain uses of sensitive data. It will also create a new California data protection agency with the power to make substantive regulations and may lead to stronger enforcement of privacy and information security. Most provisions of the CPRA come into effect on January 1, 2023, and additional investments in compliance and possible changes to business processes may be required. Other states are investigating their own laws, which may or may not be similar to the CCPA or CPRA. If we are subject to or affected by HIPAA, CCPA, CPRA or other national data protection laws, any liability arising from our failure to comply with the requirements of those laws could adversely affect our financial condition.

There are also a variety of data protection laws in other countries that may affect our business now or in the future. For example, the General Data Protection Regulation (GDPR) in Europe imposes strict requirements on the collection, use, disclosure, storage, transfer or other processing of personal data from individuals in the European Economic Area (EEA), including the provision of information to individuals in connection with data processing activities, Implementing safeguards to protect the security and confidentiality of personal data, reporting data breaches and taking specific steps when engaging third party processors. Organizations required to comply with the GDPR face greater compliance obligations and risks, including stricter regulatory enforcement of data protection requirements and potential fines for non-compliance of up to €20 million or 4% of the non-compliant organization's global annual revenue, depending on the case , which is the case larger. The GDPR may also give data subjects and consumer organizations the right to private proceedings to lodge complaints with supervisory authorities, seek legal remedies and obtain damages for violations of the GDPR. Among other things, the GDPR requires the establishment of a legal basis for the processing of data, requirements for consent from individuals to whom the personal data relates, including detailed notices for subjects and clinical trial investigators, and requirements for security of personal data and reporting of data processing obligations to competent national data processing authorities. In addition, the GDPR strengthens scrutiny of transfers of personal data from the EEA to the United States and other jurisdictions that the European Commission does not recognize as “adequate” data protection laws. Recent legal developments in Europe have created complexity and uncertainty regarding transfers of personal information from the EEA to the United States. For example, on July 16, 2020, the Court of Justice of the European Union (CJEU) invalidated the EU-US Privacy Shield Framework (Privacy Shield), under which personal data could be transferred from the EEA to US companies that register themselves under the Privacy Shield scheme certified. While confirming the adequacy of standard contractual clauses (a standard contractual form approved by the European Commission as an appropriate mechanism for transfers of personal data and a potential alternative to the Privacy Shield), the ECJ clarified that standard contractual clauses alone may not necessarily be sufficient in all circumstances. The use of standard contractual clauses must now be assessed on a case-by-case basis, taking into account the applicable legal order in the country of destination, in particular the applicable surveillance laws and the rights of the individual, additional measures and/or provisions may be necessary to carry out contractual measures, however the nature of these additional Measures currently unclear. On June 4, 2021, the European Commission issued revised Standard Contractual Clauses to reflect the decision of the ECJ and the recommendations of the European Data Protection Board. Revised Standard Contractual Clauses will be used for new data transfers relevant and in place as of September 27, 2021

Standard Contractual Clauses must be migrated to the revised Standard Contractual Clauses by December 27, 2022. The new Standard Contractual Clauses only apply to transfers of personal data outside of the EEA and not the UK; The UK Information Commissioner's Office launched a public consultation on its draft revised data transfer mechanisms in August 2021 and the UK Standard Contractual Clauses entered into force in March 2022 with a grace period of two years. There is some uncertainty as to whether the revised clauses can be used for all types of data transfers, in particular whether they can be used for data transfers to non-EEA entities subject to the GDPR. As regulators issue more guidance on mechanisms for exporting Personal Data, including situations where Standard Contractual Clauses cannot be used, and/or begin to take enforcement action, we may incur additional costs, claims and/or regulatory investigations or fines and/ or if we are otherwise unable to transfer personal data between countries and regions in which we operate, this could be due to the way we provide our services, the geographic location or the separation of our relevant systems and operations affect and adversely affect our financial results.

In addition, following the UK's withdrawal from the European Union and EEA and the end of the transition period, from 1 January 2021 we will need to comply with the GDPR and separately with the GDPR implemented in the UK, which together with the UK Data Protection Act 2018 amended, it retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR and can impose fines of up to €20m/£17m or 4% of global turnover. The relationship between the UK and the European Union and EEA in relation to certain aspects of data protection law remains unclear and it is unclear how UK data protection laws and regulations will evolve in the medium to long term. The European Commission has issued an adequacy decision in favor of the UK, allowing the transfer of data from EU Member States to the UK without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission evaluates and renews or extends that decision, which may impact our transfers of personal data.

Enforcement actions and the consequences of non-compliance are increasing in many jurisdictions. In the United States, this includes enforcement actions in response to rules and regulations made under the authority of federal agencies and prosecutors, consumer protection agencies, and legislatures. In addition, privacy advocates and industry groups have regularly proposed, and may in the future may propose, self-regulatory standards that may be legally or contractually applicable to us. If we fail to follow these security standards, we could be subject to significant fines or significant increases in costs, even if no personal information is compromised. Many state legislatures have enacted laws governing how businesses operate online, including measures related to privacy, data security, and data breaches. Laws in every US state require businesses to notify customers whose personal information has been disclosed as a result of a data breach. Laws are not consistent and compliance in the event of a widespread data breach is costly.

Compliance with U.S. and international data protection laws and regulations may require us to have stricter obligations in our contracts, limit our ability to collect, store, use, transfer, disclose and otherwise process information, our policies and update privacy and data security practices, or in some cases affect our ability to operate in certain jurisdictions. Failure by us or our employees and service providers to comply with U.S. and international data protection laws and regulations may result in governmental enforcement action (which may include civil or criminal penalties), private litigation, and/or adverse publicity, and may adversely affect our results and business operations. In addition, clinical trial subjects about whom we or our prospective collaborators receive information, and vendors who share that information with us, may contractually restrict our ability to use and disclose that information. Allegations that we violate the privacy rights of individuals, fail to comply with data protection laws, or breach our contractual obligations can be costly and time-consuming to defend even if we are not held accountable, can result in negative publicity, and adversely affect our business, financial condition, results of operations and Outlook. Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our internal information technology systems or those of any of our service providers could fail or experience security breaches, loss or leakage of data and other disruptions that could result in material disruption to our product development programs, contain confidential information related to our business, or prevent us from accessing critical information, which may expose us to liability or adversely affect our business.

We are increasingly dependent on IT systems, infrastructure and data to run our business. In the normal course of business, we collect, store and transmit confidential information (including but not limited to intellectual property, proprietary business information and personal information). It is vital that we do so securely to maintain the confidentiality and integrity of such confidential information.

Attacks on IT systems are increasing in frequency, persistence, sophistication and intensity, and are being carried out by sophisticated and organized groups and individuals with a wide range of motives and expertise. These attacks can pose significant risks to our business operations, data and information. As a result of the COVID-19 pandemic, we may also be exposed to increased cybersecurity risks due to our reliance on internet technology and the number of our employees working remotely, which could provide cybercriminals with additional opportunities to exploit vulnerabilities. Because the techniques used to gain unauthorized access or sabotage systems change frequently and often remain undetected until used against a target, we may not be able to predict these techniques or take appropriate countermeasures . We can also experience security breaches that may go undetected for an extended period of time. Even if we are identified, we may not be able to properly investigate or remediate incidents or breaches as attackers increasingly use tools and techniques designed to bypass controls, avoid detection, and remove forensic evidence or to disguise. It is not possible to prevent all cybersecurity threats to our information and technology systems and those of our third parties, over which we have less control, and any controls we have in place to that end may prove ineffective.

The occurrence of a security breach or other incident, real or perceived, could adversely affect our reputation and/or business, incur significant costs, including legal costs, damage customer confidence, impede our expansion into new markets, cause us to take remedial action or the loss of existing customers. For example, the loss of clinical trial data could delay our regulatory approval efforts and significantly increase our cost of retrieving or reproducing the data. We also rely on third parties to manufacture lorundrostat and similar events involving their computer systems could also have a material adverse effect on our business. To the extent an actual or perceived disruption or security breach affects our systems (or those of our third party employees, service providers, contractors or consultants) or results in loss or accidental, illegal or unauthorized access, use, disclosure or other processing of Personal Data or damage to our data or applications or improper disclosure of confidential or proprietary information, we may be subject to liability, further development and commercialization of lorundrostat or any future product candidate may be delayed, and we may be subject to significant fines, penalties, or liability for violations of certain privacy and security laws.

In addition, despite the implementation of security measures, our internal technology systems (including infrastructure) and those of our current and future CROs and other contractors, consultants and employees are susceptible to failure or other damage or disruption due to service interruptions, system malfunctions, viruses, cybersecurity threats (such as ransomware attacks, denial of service attacks, cyber attacks or Internet cyber intrusions, hacking, phishing and other social engineering attacks), unauthorized access or use, natural disasters, terrorism, war and telecommunications, and power outages. These information technology systems are also susceptible to security incidents resulting from the unintentional or intentional actions of our employees, contractors, consultants or other third parties. We and some of our service providers are occasionally subject to cyber attacks and security incidents and have experienced security incidents in the past and may experience security incidents in the future. If a significant systems failure, accident, or security breach occurs, it could result in disruption to our operations, or result in unauthorized disclosure of, or access to, personal information or individually identifiable health information and material disruption to our services, development programs, and our business operations, whether due to the loss of potential trade secrets or other similar disruptions. Although we currently have cyber security insurance, costs associated with any significant security breach or disruption could be significant and cause us to incur significant expenses.

We also outsource elements of our IT infrastructure and as a result various third parties may or may have access to our confidential information. If our third party service providers fail to protect their information technology systems and our confidential and proprietary information, we could be vulnerable to service disruptions, unauthorized access to our confidential or proprietary information, and liability and reputational damage. If the information technology systems of our third-party vendors and other contractors and consultants experience disruptions or security breaches, we may not have adequate recourse against those third-party vendors and may need to expend significant resources to mitigate the impact of such an event and to develop and implement safeguards to address future ones prevent events of this kind. Some of the requirements of federal, state, and foreign governments include obligations for companies to notify individuals of security breaches affecting certain categories of personal information that may result from breaches to which we or our suppliers, contractors, or organizations are exposed with whom we enter into strategic relationships.

Our business, operational and clinical development schedules and plans are subject to risks arising from the COVID-19 pandemic and other epidemic diseases.

The global COVID-19 pandemic has brought significant economic and public health challenges, affecting our employees, patients, physicians and other healthcare professionals, communities and businesses, and the U.S. and global economy and financial markets. U.S. and international government agencies in affected regions have taken and may take additional action in the future to slow the spread of COVID-19 and virus variants, including issuing various forms of stay-at-home orders and confinement of business functions outside the home. To date we have had no significant disruptions to our business operations. Although it is not possible at this time to estimate the impact that COVID-19 may have on our business in the future, particularly as we progress lorundrostat through clinical development, the ongoing spread of COVID-19 and the measures taken by government authorities and future outbreaks Epidemics or pandemics may disrupt the supply chain and manufacturing or shipment of drug substances and finished drugs for lorundrostat for use in our clinical trials and research and preclinical studies and may delay, limit or prevent our employees and CROs from continuing our research and development activities Impeding the initiation and recruitment of clinical trials and the ability of patients to participate in clinical trials, including due to measures taken that limit social interaction or the reopening of transmissions in environments mi t prevent high risk, testing, monitoring, data collection and analysis, and other related activities, any of which could delay our preclinical testing studies and clinical trials and increase our development costs, in addition to having a material adverse effect on our business, financial condition and results of operations . The COVID-19 pandemic and any future outbreaks of epidemics or pandemics may also further impact the business of the FDA, EMA or other regulatory agencies, which may result in delays in meetings related to our planned clinical trials. The COVID-19 pandemic and containment measures have and may continue to occur, and any future outbreaks of an epidemic may adversely affect global economic conditions, which could adversely affect our business and financial condition, including affecting our ability to raise money to earn capital when needed. The extent of the impact of the COVID-19 pandemic on our results will depend on future developments that are highly uncertain and unpredictable, including new information emerging about the severity of the virus, including the identification of new variants, the rate of vaccination management and measures to limit its effects.

Our business can be affected by litigation, government investigations and enforcement actions.

We currently operate in a highly regulated industry in multiple jurisdictions and may be the subject of litigation, regulatory investigations and enforcement actions on a variety of matters in the United States or in foreign jurisdictions, including but not limited to intellectual property, regulation and product liability, Environmental, whistleblower, false allegations, privacy, anti-kickback, anti-bribery, securities, commercial, labor and other claims and legal proceedings that may arise from conducting our business. Any determination that our operations or activities are not in compliance with any applicable law or regulation may be subject to the imposition of fines, civil and criminal penalties, reasonable remedies, including restitution, injunctive relief and/or other sanctions against us, and redress discoveries could adversely affect our business operations.

Litigation, regulatory investigations and enforcement actions can be costly and time-consuming. An adverse outcome that may result from any such proceeding, investigation or enforcement action

result in significant damages, fines, penalties, exclusion from government healthcare programs, deprivation of medical care, injunctive relief, product recalls, damage to our reputation, and changes in our business practices that could have a material adverse effect on our business and results of operations. Even if such a proceeding, investigation or enforcement action is decided in our favor, the investigation and defense may require significant financial and administrative resources.

Our employees and independent contractors, including lead investigators, CROs, consultants and suppliers, may engage in wrongdoing or other improper activities, including failure to comply with government standards and requirements and insider trading, that could harm our business, financial condition and operating results.

We face the risk that our employees and independent contractors, including principal investigators, CROs, consultants and suppliers, may engage in wrongdoing or other illegal activities. Misconduct by these parties may include willful, reckless and/or negligent conduct or disclosure of unauthorized activities to us in violation of: (i) FDA laws and regulations and other similar regulatory requirements, including laws that restrict reporting of truthful, complete and accurate information required by such authorities, (ii) manufacturing standards, including cGMP requirements, (iii) privacy, security, federal and state fraud and abuse laws, and other health care laws and regulations in the United States and abroad, (iv) Laws requiring truthful, complete and accurate reporting of financial information or data, or (v) laws prohibiting insider trading. Activities subject to these laws also include misusing or misrepresenting information obtained to us during clinical trials, creating fraudulent data in our pre-clinical trials or clinical trials, or illegally misappropriating any drug leading to regulatory penalties and can seriously damage our reputation. It is not always possible to detect and prevent wrongdoing by employees and other third parties, and the precautions we take to detect and prevent such activity may not be effective in controlling unknown or unmanaged risk or loss or protect ourselves from government investigations or other actions. or legal action arising from failure to comply with such laws or regulations. In addition, we are subject to the risk of any person or government alleging such fraud or other wrongdoing even where none has occurred. If such lawsuits are brought against us and we fail to defend ourselves or enforce our rights, those lawsuits could have a material impact on our business and financial results, including, without limitation, the imposition of substantial civil, criminal, and administrative penalties, damages, fines, restitution, possible disqualification from participation in Medicare, Medicaid and other government healthcare programs, incarceration, contractual damages, damage to reputation, reduced profits and future earnings, additional reporting and oversight obligations if we are subject to a business integrity agreement or similar agreement to address allegations of failure to comply with these laws and restrictions on our operations that could affect our ability to conduct our business and our results of operations.

We may engage in strategic transactions that increase our capital needs, dilute our shareholders, may cause us to incur debt or contingent liabilities, expose us to other risks, impair our liquidity, increase our spending and significantly distract management.

Although we currently have no agreements or obligations to enter into, and are not involved in, any such transactions, we may from time to time enter into strategic transactions such as business acquisitions, asset purchases, and external or internal licensing of any intellectual property, product, or technology. Other potential transactions that we may consider in the future include a variety of commercial arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. We may not be able to find suitable partners or acquisition candidates and we may not be able to complete such transactions on terms that may be favorable. Any future transactions may increase our short-term and long-term expenses, result in potentially dilutive issuance of our stock, including our common stock, or create debt, contingent liabilities, amortization charges or costs incurred in the research and development process that may affect our financial condition, could affect liquidity and earnings. Future acquisitions may also require us to obtain additional financing that may not be available on favorable terms or at all. These transactions may never be successful and may require significant time and attention from our management. In addition, the integration of companies we acquire in the future could be disruptive to our existing businesses and be a complex, risky and expensive endeavor from which we may never derive full benefit. In addition, we may suffer losses related to investments in other companies, including as a result of the failure to achieve anticipated benefits or the materialization of unanticipated liabilities or risks, which could have a material adverse effect on our results of operations and financial condition. So there is no guarantee that we will make

or successfully complete additional transactions of the type described above, any additional transactions that we enter into could have a material adverse effect on our business, results of operations, financial condition and prospects.

Our ability to use net operating losses and other tax attributes may be limited in connection with this offering or other changes of ownership.

We have suffered significant losses throughout our history, we do not expect to become profitable any time soon and we may never reach profitability. To the extent that we continue to earn taxable losses, any unused losses will be offset against future taxable income (subject to restrictions) until such unused losses expire (if any). As of December 31, 2021, we had net operating losses (NOL) of approximately $4.2 million for federal income tax purposes and $0.2 million for state income tax purposes. Our federal tax losses do not expire, but generally can only be used to offset 80% of taxable income, which may result in us having to pay federal income taxes in future years even though we generated federal tax losses in prior years. Our government NOL provisions begin to expire in varying amounts in 2041.

In addition, our NOL offsets and other tax attributes are subject to review and possible adjustment by the Internal Revenue Service (IRS) and state tax authorities. In addition, pursuant to Section 382 of the United States Internal Revenue Code of 1986, as amended (the Code), our state transfers of NOL generally may be or may be subject to an annual limit if we have had or may have in the future a "Change of Ownership". For these purposes, a “change of ownership” generally occurs when one or more shareholders or groups of shareholders who own at least 5% of a company's shares increase their holding by more than 50 percentage points from their lowest holding in any period. of three consecutive years. Period. Similar rules may apply under state tax laws. We have not yet determined the value of the cumulative change in our ownership resulting from this offering or any other transaction, or any resulting limitations on our ability to use our NOL offsets and other tax attributes. However, we believe that changes in ownership, including any changes related to this offering, may limit our ability to use our tax losses and other tax assets to meet future taxable income or tax liabilities. If we earn taxable income, such restrictions could result in increased future income taxes for us and our future cash flows could be adversely affected. We record a full allowance in respect of our tax loss carryforwards and other deferred tax assets because the ultimate realization of future benefits from these assets is uncertain.

Inflation could adversely affect our business and results of operations.

Although inflation in the United States has been relatively low in recent years, the US economy faced significant levels of inflation in 2021 and 2022. The impact of COVID-19, geopolitical developments such as the Russia-Ukraine conflict and global supply chain disruptions continue to add to uncertainty around the outlook for short- and long-term economic activity, including whether and how long inflation will persist which tariff. Rises in inflation increase our costs of raw materials, labor, materials and services and other costs necessary to grow and operate our business, and failure to secure these costs on reasonable terms could adversely affect our financial condition. Furthermore, increases in inflation along with the uncertainties surrounding COVID-19, geopolitical developments and global supply chain disruptions have resulted in and may potentially cause future global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, expensive or dilutive for us to secure additional funding. If we do not adequately respond to these risks, we could have a material adverse effect on our financial condition, results of operations or cash flows.

Risks related to our intellectual property

If we are unable to obtain, maintain and enforce any patent or other intellectual property protection for Lorundrostat or any future product or technology candidate, or if the scope of the patent or other intellectual property protection obtained is not broad enough our competitors or other third parties are developing and marketing products that are similar or identical to ours and our ability to successfully commercialize lorundrostat or future product candidates could be adversely affected.

We rely on a combination of patents, trademarks and intellectual property licenses to protect intellectual property related to lorundrostat and any future product candidates and technologies to prevent third parties from doing so

Parties copy and surpass our achievements and undermine our competitive position in our marketplace. These legal remedies provide only limited protection, and competitors or others may gain access to or use our intellectual property and proprietary information. Our success depends in large part on our ability to obtain, maintain, expand, enforce and enforce the level of our intellectual property protections in the United States and other countries relating to our product candidates and other proprietary technologies that we may develop To defend. We generally attempt to partially protect our proprietary position by filing US and foreign patent applications relating to lorundrostat and any future product candidates, manufacturing processes and methods of use. We license from Mitsubishi Tanabe a number of patents and patent applications relating to lorundrostat and structurally related compounds, the manufacture of lorundrostat and structurally related compounds, and methods of using lorundrostat. In addition to patents and patent applications licensed from Mitsubishi Tanabe, our portfolio includes pending patent applications owned exclusively by us and pending patent applications commonly owned by Mitsubishi Tanabe. If we or Mitsubishi Tanabe are unable to obtain, maintain or enforce patent protection, our business, financial condition, results of operations and prospects could be materially adversely affected.

Changes in patent laws or their interpretation in the United States and other jurisdictions may affect our or our licensor's ability to protect our intellectual property, obtain, maintain and enforce our intellectual property rights, and more generally, affect the value of our protected intellectual property or limit the scope of our protection. We cannot predict whether any patent applications we receive or license, now or in the future, will be granted as patents in any particular jurisdiction and will provide adequate protection from competitors or other third parties or, if those patents are challenged by our competitors, will do so shall be deemed invalid, unenforceable or not violated.

The patent processing process is expensive, time-consuming and complex, and we or our licensors may not be able to file, process, maintain, enforce or license all necessary or desirable patent applications or reissue applications at a reasonable cost or in a timely manner or in all jurisdictions . We may also not be able to identify patentable aspects of our research and development results in time to obtain patent protection before publication. Although we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development results, such as Any of these parties may breach agreements and disclose such results prior to filing a patent application, thereby affecting our or our licensors' ability to obtain patent protection. As a result, we may not be able to prevent third parties from using our publicly available technologies to compete with lorundrostat and future product candidates or technologies. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable in light of the prior art. In addition, disclosures of discoveries in the scientific literature often lag behind actual discoveries, and patent applications in the United States and other jurisdictions are typically not published for 18 months after filing or, in some cases, not at all. Therefore, we cannot be certain that we or our licensors were the first to invent the inventions claimed in any of our licensed patents or pending patent applications, or that we or our licensors were the first to make the inventions claimed in those patents have licensed or pending patent applications, or that we or our licensors were the first to seek patent protection for such inventions. If a third party can demonstrate that we or our licensors were not the first to manufacture or apply for patent protection for such inventions, our own or licensed patents and patent applications may not be granted as patents, and even if granted, are challenged and for declared invalid or unenforceable.

Compound patents for pharmaceutical product candidates often provide a strong form of intellectual property protection for these types of products, as such patents provide protection regardless of any type of use. We cannot be certain that claims in our pending patent applications, which relate to compositions of matter of our lorundrostat or any future product candidates, will be considered patentable by the United States Patent and Trademark Office (USPTO) or patent offices in other countries The claims in any of our issued or newly issued patents will be declared valid and enforceable by courts in the United States and other countries. Process patents protect the use of a product for the specified process. This type of patent does not prevent a competitor from manufacturing and marketing an identical product to ours for an indication outside the scope of the patented process. Even if competitors are not actively promoting their products for our specific indications, physicians can prescribe these products off-label. Off-label recipes may violate or contribute to this

Infringing method-of-use patents is a common practice, and such infringement is difficult to prevent or prosecute.

The patent position of biotechnology and pharmaceutical companies is often highly uncertain, involves complex legal and factual issues, and has been the subject of numerous litigations in recent years. Therefore, the grant, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being granted. Granted patents may not provide adequate protection for our product candidates or their intended uses from competitors, and no assurance can be given that granted patents will not infringe, design, invalidate by third parties, or effectively prevent others from commercializing competing technologies, products or products candidates. In addition, even if granted, these patents can be difficult to enforce. Obtaining and maintaining our patent protection depends on our compliance with various procedures, filing documents, paying fees and other requirements imposed by government patent authorities, and our patent protection may be reduced or revoked if we fail to comply with these requirements. If we experience non-compliance incidents that cannot be corrected and we lose our patent rights, competitors could enter the market, which would have a material adverse effect on our business. In addition, any issued patents that we may license or own that cover our lorundrostat or future product candidates may be limited or declared invalid or unenforceable if challenged in court or before governmental agencies in the United States or other countries, including the USPTO. In addition, patent terms, including any extensions or adaptations that may or may not be available to us, may not be sufficient to protect our competitive position in our product candidates for a reasonable period of time, and we may be subject to lawsuits challenging the patent, validity, Enforceability of our patents and/or other intellectual property. Changes in US patent laws or the laws of other countries may decrease the value of patents in general, thereby affecting our ability to protect our candidate products. In addition, if we experience delays in our clinical trials or delays in obtaining regulatory approvals, it would reduce the period in which we could commercialize our candidate products under patent protection. Accordingly, the patents we own and license may not give us a material competitive advantage.

In addition, the claims coverage in a patent application can be significantly reduced before the corresponding patent is granted. Even if our own or licensed patent applications are granted as patents, they must not be granted in a manner that gives us any useful protection, prevents competitors or third parties from competing with us, or gives us a competitive advantage. Any patents arising out of our patent applications may be challenged, limited, circumvented, or invalidated by third parties. Our competitors or other third parties may benefit from safe harbors under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) to conduct research and clinical trials. Consequently, we do not know whether lorundrostat or any of our future product candidates and other proprietary technologies will be or remain protected by valid and enforceable patents. Even if a patent is granted, our competitors or other third parties may circumvent the patent by developing similar or alternative technologies or products in a non-infringing manner, which could adversely affect our business, financial condition, results of operations and prospects. In addition, due to the time required for development, testing and regulatory review of our future candidate products, patents protecting candidate products may expire before or shortly after those candidate products are commercially available. As a result, our intellectual property may not give us sufficient rights to prevent others from marketing similar or identical products to ours.

The grant of a patent is not conclusive as to its invention, scope, validity or applicability, and our patent rights may be challenged in courts or patent offices in the United States and abroad. We may be filed by a third party with the United States Patent and Trademark Office (USPTO) after the prior art has been granted, in order to challenge the validity of one or more claims of our licensed patents or patents that we may have in the future , to contest. Such filings may also occur prior to the issuance of a patent, preventing the issuance of a patent based on one of our licensed or our own pending patent applications. A third party may also claim that our patent rights are invalid or unenforceable in litigation. The outcome of legal claims for nullity and unenforceability is not foreseeable. In addition, we may participate in objection, derivation, revocation, reexamination, reissuance, post-grant and inter partes review or inter partes review or inter partes proceedings and other similar proceedings in foreign jurisdictions that challenge the validity, priority or other patentability features of our patent rights. An adverse determination in a filing, lawsuit, or litigation could reduce the scope, invalidate or render unenforceable our patent rights, allow third parties to commercialize our product candidates and other proprietary technologies we may commercialize

develop and compete directly with us without payment to us, or result in our inability to manufacture or market our products without infringing on the patent rights of others. Such adverse decisions may also force us to stop using the related technology or attempt to license the rights to the prevailing party. Such procedures can also incur significant costs and consume a great deal of time from our scientists and management, even if the end result is in our favour. Any of these could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, some of our patent rights are and may in the future be co-owned by third parties, including Mitsubishi Tanabe. In the United States, each co-owner is free to license and use the technology. If we are unable to obtain an exclusive license to participate from such co-owners of such patent rights, those co-owners may license their rights to third parties, including our competitors, and our competitors may market competing products and technologies. In addition, we may need the cooperation of such co-owners of such patent rights to enforce such patent rights against third parties, and such cooperation may not be granted to us. All of these could have material adverse effects on our competitive position, business, financial condition, results of operations and prospects.

We may not be able to protect our intellectual property and proprietary rights around the world.

Filing, processing, maintaining, enforcing and defending patents on lorundrostat and any future product candidates in any country in the world is expensive, and the laws of other countries may not protect our intellectual property rights to the same extent as the laws of the United States of America. The processing of patent applications is generally a longer process and patents can be issued at a later date and with a shorter deadline than in the United States. Patentability requirements differ in certain jurisdictions and countries. In addition, the patent laws of some countries do not protect intellectual property to the same extent as United States laws. For example, patent law in most European countries and many other jurisdictions, in contrast to patent law in the United States, prevents the patentability of methods of treating and diagnosing the human body. Other countries may narrow the scope of the claims significantly and limit patent protection to specifically disclosed modalities. As a result, we may not be able to prevent others from practicing our inventions or those of our licensors in any country outside of the United States, or from selling or importing products made using our intellectual property in the United States or other jurisdictions became. Competitors may use our intellectual property or the intellectual property of our licensors in jurisdictions where we or our licensors do not seek and obtain patent protection to develop their own products, and may also export infringing products into territories where we do have patent protection but Enforcement is not as strong as in the United States. These products may compete with our products, and our owned and licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries, particularly some developing countries, do not favor the use of patents, trade secrets and other intellectual property rights, particularly those relating to biotechnology products, which may make it difficult for us to prevent infringement of our patents or our marketing of competing products under Violation of our intellectual property and general property rights. In addition, some jurisdictions such as Europe, Japan and China may have higher patentability standards than the United States, including, for example, requiring literal claims in the original patent application and restricting the use of supporting data that are not in the original patent application. Because of these increased patentability requirements, we may not be able to obtain adequate patent protection in certain jurisdictions, although the same or similar patent protection is guaranteed in the United States and other jurisdictions.

Litigation to enforce our intellectual property and proprietary rights in foreign jurisdictions can result in significant costs and divert our efforts and attention from other aspects of our business, expose our patents to risk of invalidation or narrow interpretation, and put our patent applications at risk of non-grant and may result in third parties asserting claims against us. We or our licensors cannot enforce any action brought by us or our licensors, and any claim for damages or other relief that may be granted may not be of commercial interest. As a result, our efforts to enforce our intellectual property and proprietary rights worldwide may be insufficient to obtain significant commercial benefit from the intellectual property we develop.

Many countries have compulsory licensing laws that may require the owner of a patent to license it to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited resources, which can significantly reduce the value of that patent. If we or one of our licensors are forced to license a third party with respect to patents relevant to our business, our competitive position could be adversely affected and our business, financial condition, results of operations and prospects could be adversely affected.

Obtaining and maintaining our patent protection depends on our compliance with various processes, filing documents, paying fees and other requirements imposed by government patent authorities, and our patent protection may be reduced or revoked in the event of failure to comply with these requirements.

The USPTO and many non-US government agencies require compliance with various procedural, documentation, fee payment, and similar requirements during the patent application process. In certain circumstances, we rely on our licensors to take steps to comply with these requirements in relation to our licensed intellectual property. For example, periodic maintenance fees, renewal fees, annual fees, and various other government patent and application fees must be paid to the USPTO and various government patent agencies outside the United States during the term of our own or licensed patents and applications or other patents and applications that we may have in own the future. In certain circumstances, we rely on our licensors to pay these fees to US and non-US patent authorities. In some cases, the involuntary default can be cured by paying a late fee or otherwise in accordance with applicable regulations. However, there are situations where non-compliance may result in the abandonment or lapse of the patent or patent application, resulting in a partial or total loss of patent rights in the relevant jurisdiction. In this case, potential competitors could enter the market with similar or identical products or technologies, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

The USPTO and several non-US government agencies require compliance with certain foreign registration requirements during the patent application process. For example, some countries, including the United States, China, India, and some European countries, require a foreign application license before certain patent applications can be filed. The requirements for foreign application licenses vary from country to country and depend on a number of factors, including the place where the inventive step took place, the citizenship status of the inventor, the residence of the inventor and the owner of the invention, the place of business of the owner of the invention and the nature of the matter (e.g., articles related to national security or national defense). In some cases, a foreign warehousing license can be purchased retrospectively, in accordance with applicable regulations. However, there are situations where non-compliance may result in the abandonment of a pending patent application or be grounds for revocation or invalidation of a granted patent, resulting in the loss of patent rights in the relevant jurisdiction. In this case, potential competitors could enter relevant markets with similar or identical products or technologies, which could have a material adverse effect on our business, financial condition, results of operations and prospects. We also rely on our licensors to take steps to comply with these requirements in relation to our licensed intellectual property.

The COVID-19 pandemic may affect our ability and that of our licensors to comply with these procedures, the submission of documents, the payment of fees and other requirements imposed by government patent authorities, which could materially and adversely affect our ability to obtain or maintain patent protection could for our products and product candidates.

Changes in patent laws or their interpretation can reduce the value of patents in general, thereby affecting our ability to protect our products.

Changes in patent laws or the interpretation of patent laws in the United States may increase the uncertainties and costs associated with processing patent applications and enforcing or defending granted patents. Assuming other patentability requirements are met, prior to March 2013 in the United States, the first inventor of the claimed invention was entitled to the patent, while outside the United States, whoever first filed a patent application was entitled to the patent. After March 2013, pursuant to the Leahy-Smith America Invents Act (the America Invents Act), enacted in September 2011, the United States transitioned to a first-inventor-to-file system where, provided other patentability requirements are met, the first inventor to become a patent application

Right to a patent for an invention, regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application with the USPTO after March 2013 but before us or our licensors could therefore be granted a patent covering an invention made by us or our licensors, even if we made the invention before the third party made it Page. This requires us to be aware from the invention to the filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period after filing or until issuance, we cannot be certain that we or our licensors were the first to (i) file patent applications relating to lorundrostat or others our product candidates and other proprietary technologies we may develop, or (ii) invent any of the inventions claimed in our patents or patent applications.

The America Invents Act also includes a number of significant changes that affect the processing of patent applications and may also affect patent litigation. This includes allowing third-party protests and filing prior art with the USPTO during the patent process, as well as additional procedures for challenging the validity of a patent through post-grant processes administered by the USPTO, including post-grant review, Inter -Partes review, and derivation. Because of a lower standard of proof in USPTO litigation compared to the standard of proof in US federal courts required to invalidate a patent claim, a third party in a USPTO litigation could present sufficient evidence for the USPTO to invalidate a claim even if the the same evidence would not be sufficient to invalidate the claim if presented for the first time in a complaint in a district court. Consequently, a third party may attempt to use USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court proceeding. As a result, the America Invents Act and its implementation could increase the uncertainties and costs associated with processing our patent applications and enforcing or defending patents issued out of those patent applications, which could materially adversely affect our business, financial condition and results of operations could affect operations and prospects.

In addition, the patent positions of companies involved in the development and marketing of drugs are particularly uncertain. Recent decisions by the US Supreme Court have narrowed the scope of patent protection available in certain circumstances and weakened patent owners' rights in certain situations. We cannot predict how decisions by the courts, the US Congress or the USPTO may affect the value of our patent rights. This combination of events created uncertainty as to the validity and enforceability of patents once granted. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations regarding patents may change unpredictably, which could have a material adverse effect on our existing patent portfolio and our ability to protect and apply our intellectual property in the future. Likewise, changes in patent laws and regulations in other countries or jurisdictions, or changes in the organs of governmental agencies that apply them, or changes in the manner in which the relevant governmental agency applies patent laws or regulations, may weaken our ability to obtain or obtain new patents Apply for patents that we have licensed to use or that we may obtain in the future.

Patents granted for our candidate products may be deemed invalid or unenforceable if challenged in court or before administrative agencies in the United States or abroad.

Our patent rights may be the subject of priority, validity, invention and enforceability disputes. Legal processes related to intellectual property claims, whether valid or unfounded, are unpredictable and generally expensive and time-consuming, and are likely to divert significant resources from our core business, including distracting our management and scientific staff from their normal duties and generally damaging ours business . If we or our licensors are unsuccessful in any of these proceedings, such patents and patent applications may be limited, invalid or declared unenforceable, we may need to obtain licenses from third parties which may not be on commercially reasonable terms or in or we may need to develop , manufacture and commercialize lorundrostat or future product candidates. Any of these could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we or our licensors take legal action against a third party to enforce a patent for lorundrostat or one of our future product candidates, the defendant may claim that that patent is invalid or unenforceable. In US patent litigation, counterclaims by defendants alleging invalidity or unenforceability are common. Grounds for a validity challenge may include an alleged failure to meet a number of legal requirements, including lack of novelty, obviousness, lack of eligibility, lack of sufficient written description, non-claim of patentable subject matter, or a duplicate patent of the wisdom of type. Reasons for a

the claim of unenforceability may be a claim that someone associated with the patent process withheld relevant information from the USPTO or made a misleading statement during the process. Third parties may have claims challenging the validity or enforceability of a patent before administrative authorities in the United States or abroad, including outside the context of litigation. These mechanisms include review, post-grant review, adversarial review, intervention procedures, derivation procedures, and equivalent procedures in foreign jurisdictions (eg, opposition procedures). Such proceedings may result in the revocation, cancellation or modification of our patent rights so that they no longer cover our candidate products or prevent others from competing with our candidate products. The outcome of legal claims for nullity and unenforceability is not foreseeable. With regard to the question of validity, for example, we cannot be sure that there is no prior art invalidation of which we or our license partners and the patent examiner were unaware during the proceedings. If a third party were to assert a legal claim of invalidity or unenforceability, we would lose patent protection for lorundrostat and all future product candidates, at least in part and perhaps in full. Such loss of patent protection would have a material adverse effect on our business, financial condition, results of operations and prospects.

We cannot guarantee that patent rights relating to inventions described and claimed in our pending patent applications will be granted or that patents based on our patent applications will be unchallenged and held invalid and/or unenforceable.

We have pending US and foreign patent applications in our portfolio; However, we cannot predict:

•whether and when patents may be granted based on our patent applications;

•the scope of patent issues based on our patent applications;

•whether the patent claims based on our patent applications provide protection from competitors;

•whether third parties will find ways to invalidate or circumvent our patent rights;

•whether other patents will be obtained that claim aspects similar to those covered by our patents and patent applications;

•whether we will have to take any legal or administrative action to enforce and/or defend our patent rights, which will be costly, win or lose; and or

•whether patent applications we own or license will result in patents being issued with claims covering lorundrostat or any of our future product candidates or uses thereof in the United States or other countries.

Claims in our pending patent applications directed to lorundrostat and any of our future product and/or technology candidates may not be considered patentable by the USPTO or patent offices in other countries. Such patent applications cannot be issued as granted patents. One aspect of determining the patentability of our inventions depends on the scope and content of the "prior art," information that was available or believed to be available to a person skilled in the art prior to the priority date of the claimed invention. There may be prior art of which we are not aware that could affect the patentability of our claims or, if granted, affect the validity or enforceability of a claim. Even if patents are granted based on our patent applications, third parties may challenge their validity, enforceability, or scope, which may result in limitation, invalidity, or unenforceability of such patents. In addition, the patents in our portfolio, even if uncontested, may not sufficiently preclude others from practicing the relevant technology or prevent others from using our claims. If the breadth or strength of our intellectual property position related to our candidate products is threatened, this could discourage companies from working with us to commercialize our candidate products and jeopardize our ability. In the event of a litigation or administrative proceeding, any court in the United States or other countries may find that claims under any of our issued patents are invalid.

Patent terms may not be sufficient to protect the competitive position of our candidate products for a reasonable period of time.

Patents have a limited shelf life. In the United States, if all maintenance fees are paid on time, the natural expiration of a patent is generally 20 years from the earliest filing date of the US non-provisional or international patent. Various renewals may be available, but the duration of a patent and the protection it affords are limited. Even if patents are acquired that cover our product candidates, we may be vulnerable to competing products, including generics, after the patent expires. Given the time required for the development, testing and regulatory review of new product candidates, patents protecting these product candidates may expire before or shortly after these candidates are commercially available. As a result, our proprietary and licensed patent portfolio may not provide us with sufficient rights to prevent third parties from marketing similar or identical products to ours. If we do not have enough patents to protect our products, our business, financial condition, results of operations and prospects will be adversely affected.

Failure to obtain patent renewals and equivalent renewals outside of the United States for our candidate products could cause significant harm to our business.

Depending on the timing, length and specifics of any FDA approval of lorundrostat or any future product candidates we may develop, one or more of our licensed US patents or issued US patents that we may hold in the future may be eligible Patent Term Extension under the Hatch-Waxman Amendments. The Hatch-Waxman amendments allow for a patent term extension of up to 5 years to compensate for the missed patent term during the FDA's regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of fourteen (14) years from the date of product approval, only 1 patent can be extended and only claims to the approved drug, a method of its use, or a Procedure for whereby it can be extended. Similar patent term restoration provisions to compensate for the delay in commercialization caused by regulatory review are also available in certain foreign jurisdictions, for example in Europe under the Supplementary Protection Certificate. However, we may not receive an extension for a variety of reasons, including failure to exercise due diligence during the testing or regulatory review process, failure to apply within applicable time limits, failure to apply before relevant patents expire, or failure to comply with other applicable requirements. In addition, the applicable period or scope of granted patent protection may be less than required by us. In addition, to the extent that we wish to apply for a patent term extension based on a patent that we license from a third party, we may require the cooperation of that third party. If we are unable to obtain the patent term extension or the foreign equivalent, or if the term of such an extension is shorter than that requested by us, our competitors could, after our patent expires, and our business, financial and business results and prospects could be significantly affected).

We may be subject to lawsuits challenging the invention of our patents and other intellectual property.

We or our licensors may be subject to claims that former employees, consultants, employees or other third parties have an interest in our patent rights, potential trade secrets or other intellectual property as inventors, co-inventors or owners of potential trade secrets. For example, we may have inventory disputes arising from the conflicting obligations of consultants or others involved in the development of our product candidates and other proprietary technologies we may develop. Legal proceedings may be necessary to defend against these and other claims challenging the invention or our patent rights, potential trade secrets, or other intellectual property. In addition to paying monetary damages, if we or our licensors fail to defend such claims, we may also lose valuable intellectual property rights on how we can develop. Even when we successfully defend against such claims, litigation can result in significant costs and distraction for our management and other employees. Any of these could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we are unable to maintain the confidentiality of potential trade secrets, our business and competitive position will be damaged.

In addition to seeking patent protection for our proprietary product and technology candidates, we may also rely on trade secret protections and non-disclosure agreements to protect our unpatented know-how, technology and other proprietary information and to maintain our competitive position. We strive to protect some potential trade secrets and other proprietary technologies by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as B. our employees, contractors, CROs, contract manufacturers, consultants, consultants and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Trade secrets and know-how can be difficult to protect. We cannot guarantee that we have applicable agreements in place with every party that has or has had access to potential trade secrets or proprietary technologies and processes. Despite these efforts, there may be occasions when one of these parties breaches agreements and discloses our proprietary information, including potential trade secrets, and we may not be able to obtain adequate remedies for such breaches. Controlling unauthorized uses and disclosures is difficult, and we do not know if the measures we take to protect our proprietary technologies will be effective. We cannot guarantee that potential trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not have access to potential trade secrets. Enforcing a claim that a party has unlawfully disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our potential trade secrets have been obtained legally or have been independently developed by a competitor or other third party, we have no right to prevent them from using that technology or information to compete with us.

In addition, others can independently discover potential trade secrets and proprietary information. If any of our potential trade secrets have been legally acquired or independently developed by a competitor or other third party, we have no right to prevent them, or those to whom they share it, from using that technology or information to compete with us. If any of our potential trade secrets were disclosed or misused, or if such information were independently developed by a competitor or other third party, our competitive position would be significantly and adversely damaged.

We may be subject to claims that third parties have an proprietary interest in potential trade secrets. For example, we may have disputes arising from conflicting obligations of our employees, consultants or others involved in the development of our product candidate. Legal proceedings may be necessary to defend against these and other claims challenging ownership of potential trade secrets. If we fail to defend such claims, in addition to paying damages, we could also lose valuable trade secret rights, such as Such an outcome could have a material adverse effect on our business. Even when we successfully defend against such claims, litigation can result in significant costs and distraction for our management and other employees. Any of these could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may not identify relevant third-party patents or misinterpret the relevance, scope, or expiration of a third-party patent, which could affect our ability to develop and commercialize our products and product candidates.

We cannot guarantee that any patent search or review performed by us or our licensors, including the identification of relevant patents, the scope of patent claims, or the expiration of relevant patents, is complete or thorough, nor can we be assured that we or our licensors have any Identified third party patents and pending US and foreign patent applications relevant or necessary to the commercialization of our current and future products and candidate products in all jurisdictions. Patent applications in the United States and elsewhere are not published until about 18 months after the earliest filing for which priority is claimed, which earliest filing date is commonly referred to as the priority date. Therefore, patent applications for our candidate products may have been filed by others without our knowledge. In addition, published pending patent applications may be subsequently modified to cover product candidates or use of our product candidates, subject to certain limitations. The scope of a patent claim is determined by the

Legal interpretation, the wording of a patent claim, the written disclosure in a patent and the history of patent processing. Our interpretation of the relevance or scope of a patent or pending patent application may be incorrect, which could adversely affect our ability to market our products. We may incorrectly determine that our products or product candidates are not covered by a third-party patent, or we may incorrectly predict whether a pending third-party patent application will make relevant claims. Our determination of the expiration date of US or foreign patents that we believe to be essential may be incorrect, and we may erroneously conclude that a third-party patent is invalid and unenforceable. Our failure to correctly identify and interpret relevant patents could affect our ability to develop and commercialize our products and product candidates. If we fail to identify and properly interpret the relevant patents, we may be subject to claims of infringement. In addition, because the claims of published patent applications may change between publication and issuance of the patent, published patent applications may give rise to claims that we infringe. As the number of competitors in the market and the number of patents granted in this area grow, the possibility of patent infringement claims increases. Additionally, in recent years individuals and groups that are not practicing entities, commonly referred to as "patent trolls," have acquired patents and other intellectual property assets to pursue infringement claims and settlements to achieve. From time to time, we may receive threatening letters, warnings, or "invitations to license" or we may become the subject of complaints that our products and business activities infringe or infringe on the intellectual property rights of others. We cannot guarantee that we will be able to successfully resolve or otherwise resolve such infringement claims. If we fail in such a dispute, in addition to the obligation to pay damages, we may be barred, temporarily or permanently, from marketing any of our Candidate Products that are found to be infringing. We may also, where possible, be required to redesign candidate products or services so that we no longer infringe the intellectual property rights of others. Any of these events, even if we were to win, could require us to divert significant financial and administrative resources that we could otherwise devote to our business.

We may be subject to claims alleging that our employees, consultants or advisors misappropriated or disclosed alleged trade secrets of their current or former employers, or claims alleging ownership of what we consider our intellectual property.

Some of our employees, consultants and consultants are or have been employed by universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. While we try to ensure that our employees, consultants and consultants do not use the proprietary information or know-how of third parties in their work for us, we may be subject to claims that we or those individuals use or disclose intellectual property, including trade secrets, owned by others Protected information. , a person's current or former employer. Legal proceedings may be required to defend against these claims. If we fail to defend such claims, in addition to paying damages, we may also lose valuable intellectual or personal property rights. Even if we successfully defend against such claims, litigation could result in significant costs and distract our management.

Although it is our policy to require our employees and contractors who may be involved in the creation or development of intellectual property to sign agreements that transfer that intellectual property to us, we may not be able to enter into such an agreement sign with any party who actually designs or develops intellectual property that we consider our own. The assignment of intellectual property rights may not be self-enforcing, or assignment agreements may be violated, and we may be forced to make claims against third parties or defend claims they make against us to determine ownership of what we do hold for our intellectual property property. Such complaints could have a material adverse effect on our business, financial condition, results of operations and prospects.

Third-party claims for intellectual property infringement, misappropriation, or other violations against us or our contributors can be costly and time-consuming and can prevent or delay the development and commercialization of our product candidates.

Our success in business depends in part on our ability to avoid infringing, misappropriating or otherwise infringing on the patents and other intellectual property rights of others. There is a significant body of complex litigation relating to patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings to challenge patents, including intervention, derivation and review proceedings before the USPTO or opposition and other similar proceedings in foreign jurisdictions. Such

Disputes may result in loss of exclusivity or freedom of operation, or in the limitation, invalidation, or determination of unenforceability of any patent claim, in whole or in part, which may limit our ability to prevent others from using similar or identical products and techniques without them or to market or limit the duration of patent protection for our technology. As discussed above, recent changes in US law known as patent reform have also introduced new procedures, including inter-party examination and post-grant examination. As mentioned above, this reform adds uncertainty to the possibility of challenging our patent rights in the future.

There are numerous issued US and foreign patents and pending third-party patent applications in areas in which we market or plan to market lorundrostat. As the biotechnology and pharmaceutical industries expand and more patents are granted, and as we gain visibility and market presence as a public company, there is an increased risk that lorundrostat or future product candidates and commercialization activities will result in claims of patent infringement rights of third parties. We cannot guarantee that lorundrostat or any future product candidates we develop will not infringe existing or future patents of third parties. We may not be aware of any patents that have already been granted, which we have received from third parties, e.g. B. could accuse a competitor in the areas in which we are developing lorundrostat or our future product candidates. It is also possible that patents owned by third parties that we know but do not believe have been infringed, or who we believe have valid objections to claims of patent infringement, could be infringed by us. It is not uncommon for corresponding patents granted in different countries to have different scopes of protection, so that in one country a third-party patent does not pose a material risk, but in another country a corresponding third-party patent may pose a material risk to lorundrostat and any future product candidates. Therefore, we monitor third party patents in relevant pharmaceutical markets. In addition, because patent applications can take many years to be granted, there may be pending patent applications that may later lead to the issuance of patents that we may infringe.

In the event that third parties claim that we have infringed on their patents or that we are using their proprietary technology without authorization and commence legal action against us, even if we believe such claims are unfounded, a court of competent jurisdiction may find such patents valid , enforceable and violated by us. Defending claims of infringement, regardless of their merit, would result in significant litigation costs and would divert management and other employees' resources from our business and damage our reputation. If an infringement claim against us is successful, we may be prevented from developing or commercializing the infringing products or technologies. In addition, we may be required to pay substantial damages, including treble damages and attorneys' fees for willful infringement, obtain one or more third-party licenses, pay royalties, and/or modify our infringing products or technology, which may be impossible or require significant investment of time and money . These licenses may not be available on commercially reasonable terms, or at all. Even if we are able to obtain a license, the license is likely to require us to pay royalties or royalties, or both, and the rights granted to us may not be exclusive, which could result in our competitors accessing the same intellectual property . If we are unable to obtain a required license for a third-party patent on commercially reasonable terms, or at all, we may not be able to commercialize the infringing products or technology, or such commercialization efforts may be significantly delayed, which in turn significantly harm our business. In addition, we may pursue patent litigation relating to third party patents in the future, including as a defense against prior claims of infringement. The outcome of such challenges is unpredictable.

Even if decided in our favor, the above procedure can be very expensive and time consuming, especially for a company of our size. Such lawsuits could significantly increase our operating losses and reduce the resources available for development activities or future sales, marketing or distribution activities. We may not have sufficient financial or other resources to properly conduct such procedures. Some of our competitors may be better able to bear the costs of legal or administrative proceedings than we are because of greater financial resources. Such procedures can also consume a lot of time for our technical and administrative staff and distract them from their normal duties. Uncertainties resulting from such proceedings can affect our ability to compete in the market. In addition, there may be public announcements of the results of hearings, motions or other preliminary proceedings or developments, and if securities analysts or investors perceive such results to be adverse, the price of our common stock could be materially adversely affected. The occurrence of any of the above situations could have a material adverse effect on our business, financial condition or results of operations.

We may be involved in legal action to protect or enforce our patent and other intellectual property rights, which can be costly, time-consuming and unsuccessful.

third parties, such as B. a competitor, may infringe our patent rights. In an infringement proceeding, a court may decide that a patent owned or licensed to us is invalid or unenforceable, or may refuse to prevent the other party from using the invention in question because the patent does not cover the technology in question . In addition, our patent rights or those of our licensors may be involved in patent, priority or validity disputes. Defeating or defending against such claims can be costly and time-consuming. An adverse outcome to litigation could expose our patent rights to the risk of being invalidated, declared unenforceable, or interpreted restrictively. In addition, due to the significant amount of disclosure required in connection with intellectual property litigation and litigation, there is a risk that some of our confidential information could be compromised through disclosure during such litigation and litigation.

Even if they are decided in our favor, litigation or other legal proceedings related to intellectual property claims can cause us significant costs and distract our employees from their normal duties. In addition, there may be public announcements of the results of hearings, motions or other preliminary proceedings or developments, and if securities analysts or investors perceive such results to be adverse, the price of our common stock could be materially adversely affected. Such litigation or proceedings could significantly increase our operating losses and reduce the resources available for development activities or future sales, marketing or distribution activities. We may not have sufficient financial or other resources to properly conduct such litigation or proceeding. Some of our competitors may be able to bear the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties arising from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

If our trademarks and trade names are not adequately protected, we may not be able to establish recognition for our names in our markets of interest and our business could be harmed.

Our trademarks or trade names, registered or unregistered, may be challenged, infringed, diluted, circumvented, declared generic, or intended to infringe, abuse, or violate other marks. We may not be able to protect our rights in these trademarks and trade names, which we need to be known to potential partners or customers in the markets of interest. During the trademark registration process, we may receive rejections of our applications from the USPTO or other foreign jurisdictions. While we have the ability to respond to such rejections, we may not be able to overcome them. If our trademarks are successfully challenged, we may be forced to rebrand our products, which can result in a loss of brand awareness and may require us to devote resources to promoting and marketing new brands. In addition, third parties have the opportunity to object to pending trademark applications and request cancellation of registered trademarks from the USPTO and similar authorities in many foreign jurisdictions. Opposition or cancellation proceedings may be instituted against our trademarks, which may not survive such proceedings. In addition, any name we propose for use with lorundrostat or any future product candidate in the United States, whether we have registered it as a trademark or have applied for registration, must be approved by the FDA. Similar requirements exist in Europe. The FDA typically conducts a review of proposed product names, including an assessment of the potential for confusion with other product names. If the FDA or equivalent governing body in a foreign jurisdiction objects to one of our proposed trademarked product names, we may need to expend significant additional resources to find a suitable replacement name that falls under trademark laws. will not infringe, abuse, or otherwise violate the existing rights of any third party and are acceptable to the FDA. Additionally, in many jurisdictions, owning and maintaining a trademark registration may not provide an adequate defense against a later infringement claim by a prior trademark owner.

We may not be able to obtain, protect or enforce our rights in these trademarks and trade names, which we need to establish ourselves with potential partners or customers in our markets of interest. From time to time, competitors or other third parties may adopt trade names or trademarks similar to ours, hindering our ability to build brand identity and potentially creating confusion in the marketplace. In addition, there may be potential trade name or trademark infringement, misappropriation, dilution or other claims by owners of other registered trademarks or trademarks that include variations of our registered or unregistered trademarks or trade names. about

If we are unable to build long-term recognition based on our brands and trade names, we may not be able to compete effectively and our business could be adversely affected. Our efforts to obtain, enforce or protect our proprietary rights in trademarks, trade names, domain names or other intellectual property may be ineffective and result in significant costs and the diversion of resources and adversely affect our business, financial condition, results of operations and prospects .

Intellectual property rights do not necessarily cover all potential threats.

The level of future protection afforded by our intellectual property rights is uncertain because intellectual property rights are subject to limitations and may not adequately protect our business or allow us to maintain our competitive advantage. For example:

•others may manufacture products similar to lorundrostat or future product candidates or use similar technology not covered by patent claims we license or own;

•we or our licensors may not have been the first to make the inventions covered by our current or future patent applications;

•We or our licensors may not have been the first to file patent applications covering our or your inventions;

•others may independently develop similar or alternative technologies or duplicate our technologies or those of our licensors without infringing on our intellectual property rights;

•Our current or future patent applications from our licensors may not result in patents being granted;

•any patent issued by our licensors of our current or future patent applications may be deemed invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;

•Others may have access to the same intellectual property rights licensed for future use on a non-exclusive basis;

•our competitors or other third parties may conduct research and development activities in countries where we or our licensors do not have patent rights and then use the information obtained from those activities to develop competitive products for sale in our major commercial markets;

•we may not develop additional proprietary technology that is patentable;

•the patents or other intellectual property rights of others could harm our business; And

•We may choose not to seek patent protection to protect certain trade secrets or know-how, and a third party may subsequently file a patent application covering that intellectual property.

Should any of the above occur, it could adversely affect our business, financial condition, results of operations and prospects.

We are partially dependent on licensed intellectual property owned by third parties and our licensors may not always act in our best interests. If we fail to perform our obligations under our intellectual property licenses, if the licenses are terminated, or if disputes arise regarding those licenses, we could lose significant rights that are important to our business.

We are part of the Mitsubishi license under which we receive intellectual property rights important to lorundrostat and our business and may enter into additional license agreements with other third parties in the future. The Mitsubishi License imposes on us various development, regulatory and/or commercial due diligence, milestone and/or license fee payments and other obligations, and we expect that any future license agreements in which we license intellectual property impose on us. We may have to spend significant time and attention ensuring that we meet our obligations under such agreements, which may divert management's time and attention from our research and development programs or other day-to-day activities. If we fail to perform our obligations under those contracts or are subject to bankruptcy proceedings

litigation, the licensor may have the right to terminate the license, in which case we may not be able to develop or market products covered by the license, or we may be prosecuted for breach of these agreements.

If we or our licensors do not adequately protect our licensed intellectual property, our ability to commercialize lorundrostat or future product candidates could be adversely affected. We do not have complete control over the maintenance, prosecution and litigation of our licensed patents and patent applications, and we may have limited control over future intellectual property that may be licensed. For example, we cannot be assured that activities such as maintenance and processing by our licensors have been or will be performed in accordance with applicable laws and regulations or will give rise to valid and enforceable patents and other intellectual property rights. Our licensors' infringement proceedings or defense activities may be less vigorous than if we had conducted them ourselves, or they may not be conducted in our best interests.

In addition, the agreements under which we license intellectual property or technology from third parties are complex, and certain provisions of those agreements are subject to multiple interpretations. Resolving any disagreements over the interpretation of the Contract may limit the scope of our rights to the relevant patents, know-how and proprietary technology, or increase our financial or other obligations under the Contract. Disputes that may arise between us and our licensors in relation to intellectual property subject to a license agreement may include disputes relating to:

•the scope of the rights granted under the license agreement and other matters of interpretation;

•whether and to what extent our technologies and processes infringe any intellectual property of the licensor that is not the subject of the license agreement;

•our right to sublicense patents and other rights to third parties in collaborative development relationships;

•our due diligence requirements in relation to the use of the Licensed Technology in connection with our development and commercialization of lorundrostat or future product candidates and what activities satisfy those due diligence requirements; And

•Ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us and our licensors.

If disputes over the intellectual property we license prevent or impair our ability to maintain our current license agreements on acceptable terms, we may not be able to successfully develop and commercialize the affected technology or lorundrostat or future product candidates. As a result, any termination or dispute over our intellectual property licenses could result in our loss of our ability to develop and commercialize lorundrostat or any future product candidate, or we could lose other significant rights, any of which could have a material adverse effect on our business , our financial condition, our results of operations and our prospects.

For example, our agreements with some of our third party research partners state that enhancements developed over the course of our relationship may be owned solely by us or our third party research partner, or jointly between us and the third party. If we determine that rights to such improvements owned exclusively by a research partner or other third party with whom we work are necessary to commercialize lorundrostat or a future product candidate, or to maintain our competitive advantage, we may need to obtain a license from that third party to do so, use improvements and further develop, manufacture or commercialize lorundrostat or future product candidates. We may not be able to obtain such a license exclusively, on commercially reasonable terms, or in any way that could prevent us from commercializing lorundrostat or any future product candidate, or allow our competitors or others an opportunity to exploit technologies access that are important to our business. We may also need the cooperation of co-owners of our intellectual property to enforce that intellectual property against third parties, and such cooperation may not be granted to us.

We may not acquire or maintain the necessary rights to product components and processes for our development pipeline through acquisitions and licenses.

The growth of our business may depend in part on our ability to acquire, license or use the intellectual property and proprietary rights of others. For example, lorundrostat or future product candidates may require specific formulations to work effectively and efficiently, we may develop product candidates that incorporate our compounds and existing pharmaceutical compounds, or we may be required by the FDA or similar foreign regulatory agency to provide a supplemental diagnostic test or testing of our product candidates, for which we may need to obtain intellectual property rights from third parties. In addition, with respect to patents or other intellectual property rights that we may have in common with third parties, we may seek licenses from such co-owners of such patents. We may not be able to acquire or license from third parties compositions, methods of use, processes or other intellectual property that we believe are necessary or important to our business operations. In addition, we may not be able to obtain such licenses at a reasonable cost or on reasonable terms. In this case, we may need to stop using the compositions or methods covered by those third party intellectual property rights and may need to seek to develop alternative approaches that do not infringe, abuse or violate those intellectual property rights, which may incur additional costs and Development delays even if we are able to develop such alternatives that may not be feasible. Even if we are able to obtain a license, it may be non-exclusive, meaning our competitors may also have access to the same technologies licensed to us. In this case, we may have to spend significant time and resources developing or licensing replacement technologies.

In addition, we may work with academic institutions to accelerate our research or pre-clinical development through written agreements with those institutions. In certain cases, these institutions offer us the opportunity to negotiate a license for the institution's technology rights resulting from the collaboration. Even if we have such an option, we may not be able to negotiate a license from the Institution within the timeframe stated or on terms acceptable to us. If we are unable to do so, the institution may assign the intellectual property rights to a third party, which may prevent us from proceeding with our program.

The licensing and acquisition of third party intellectual property rights is an area of ​​competition, and companies that may be more established or resourced than us may also pursue strategies to license or acquire third party intellectual property rights that we deem necessary or attractive. to commercialize lorundrostat or a future product candidate. Established companies may have a competitive advantage over us because of their size, financial resources and greater capacity for clinical development and commercialization. In addition, companies that see us as competitors may be reluctant to assign or license rights to us. There is no guarantee that we will be able to successfully complete these types of negotiations and ultimately acquire the intellectual property rights related to additional product candidates that we intend to develop or commercialize. If we are unable to obtain necessary third-party intellectual property rights or maintain existing intellectual property rights that we own, we may have to discontinue development of certain programs and our financial condition, results of operations and prospects may be adversely affected.

Our intellectual property licensed from third parties may be subject to proprietary rights.

Our current or prospective licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for non-commercial research and academic purposes, to publish general scientific research related to the technology, and customary scientific and scholarly Make Disclosures Related Information The Technology. It is difficult to monitor whether our licensors restrict use of the technology to these purposes, and if misused, we may incur significant costs to enforce our rights in our licensed technology.

Government agencies may provide funding, facilities, personnel, or other support related to the development of intellectual property owned or licensed to us. These government agencies may have withheld rights to this intellectual property. For example, the United States federal government retains certain rights in inventions made with its financial support under the Patent and Trademark Act Amendments Act or the Bayh-Dole Act; this includes the right to grant, or require from us, compulsory licenses or sublicenses of such intellectual property to third parties in certain circumstances, including where necessary to comply with health requirements

and safety requirements that we do not adequately meet, or when necessary to meet public use requirements set forth by federal regulations or to manufacture products in the United States. Any exercise of these rights, including with respect to any required sublicenses of these licenses, may result in the loss of material rights and affect our ability to market Licensed Products. While it is our policy not to involve our university partners in projects where there is a risk of government funds being confused, we cannot be certain that jointly developed intellectual property is free from government rights. If in the future we co-own or license technology that is critical to our business and that was developed in whole or in part with government funds that are subject to certain government laws, our ability to patent or otherwise use such technology may be affected become .

Risks Associated with Our Common Stock and This Offering

There was no public market for our common stock. An active, liquid and orderly market for our common stock may not develop, or we may not meet the Nasdaq requirements for continued listing in the future, and our stock may be delisted and you may not be able to resell your common stock at the IPO price or at all.

Prior to this offering, there was no public market for our common stock. Although we have applied to list our common stock on the Nasdaq Global Market (Nasdaq), an active trading market for our common stock may never develop or be sustained following such offering. We and the agents of the underwriters will negotiate the IPO price of our common stock. This price does not necessarily reflect the price at which market investors will be willing to buy and sell our shares following this offering. In addition, it is possible that an active trading market will not develop or, if it does, not be maintained after the consummation of this Offer. The lack of an active market could prevent you from selling your shares when you wish or at a price you think is fair. An inactive market could also affect our ability to raise capital by selling shares and could affect our ability to acquire other companies or technologies using our shares as consideration, which in turn could adversely affect our business.

If, after listing, we fail to meet Nasdaq's ongoing listing requirements, such as For example, corporate governance requirements or the minimum closing offer price requirement, Nasdaq may take action to delist our common stock. Such delisting would likely adversely affect the price of our common stock and affect your ability to sell or buy our common stock at will. In the event of a de-registration, we cannot assure you that any action taken by us to restore listing compliance would allow our common stock to be re-listed, would stabilize the market price or improve the liquidity of our common stock, would prevent our common stock from selling the shares below the minimum bid price requirement of Nasdaq fall or avoid future non-compliance with Nasdaq listing requirements.

The trading price of our common stock can be very volatile and buyers of our common stock could incur significant losses.

Our share price is likely to be volatile. The stock market in general, and the stock market for biopharmaceutical companies in particular, has experienced extreme volatility that is often unrelated to the operational performance of specific companies. Because of this volatility, investors may not be able to sell their common shares at or above the initial issue price. The market price of our common stock may be affected by the factors discussed in this Risk Factors section and many others, including:

•results of our clinical and pre-clinical studies and results of studies by our competitors or others in our industry;

•our ability to enroll subjects in our future clinical trials;

•our ability to obtain and maintain regulatory approvals for lorundrostat or future product candidates, or additional indications therefor, or limitations on certain label indications or patient populations for their use, or changes or delays in the regulatory review process;

•regulatory or legal developments in the United States and other countries;

•changes in the structure of health insurance systems;

•the success or failure of our efforts to identify, develop, acquire or license additional product candidates;

•innovations, clinical trial results, product approvals and other developments by our competitors;

•Announcements by us or our competitors regarding significant acquisitions, strategic partnerships, joint ventures or capital commitments;

•the level and rate of medical and market acceptance of any of our current and future product candidates;

•delays or shortages in manufacture, supply or distribution, including our inability to obtain reasonable supplies of Products at reasonable prices or otherwise;

•changes in our relationship with manufacturers, suppliers, employees or other strategic partners;

•achieving anticipated product sales and profitability;

•changes in our financial results or those of companies that appear to be similar to us, including changes in securities analysts' or investors' expectations;

•market conditions in the biopharmaceutical industry and securities analyst reports or recommendations;

•trading volume of our common stock;

•inability to obtain additional financing or financing on unattractive terms;

•sales of our stock by us, our insiders or our shareholders and anticipation of lock-up releases;

•general economic, industry and market conditions, other events or factors, many of which are beyond our control;

•actual or anticipated fluctuations in our financial condition and results of operations;

•Issuing press releases from other companies in our industry and particularly direct competitors, including regarding adverse developments related to the safety, efficacy, accuracy and usability of their products, reputational issues, reimbursement coverage, regulatory compliance and product recalls;

•announcement or course of geopolitical events (including those related to the conflict between Russia and Ukraine);

•additions or departures of executives or key personnel;

•intellectual property, product liability or other litigation against us or our inability to enforce our intellectual property;

•Changes in our capital structure, such as B. future bond issuance and raising of additional debt; And

•Changes in accounting standards, policies, guidelines, interpretations or principles.

In addition, stockholders have in the past filed class action lawsuits against biopharmaceutical companies after periods of fluctuation in the market prices of those companies' shares. If such litigation were brought against us, we could incur significant costs, divert the attention and resources of our management, and cause harm.

our reputation, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We have broad discretion in using the net proceeds from this offering and may use them ineffectively, in a way you and other shareholders do not agree with, or in a way that does not add value to your investment.

Our management will use the net proceeds from this offering at its sole discretion, including for any of the purposes described under "Use of Proceeds." Due to the number and variability of the factors that determine our use of the net proceeds from this offering, your final use may differ materially from your current intended use. Our management may not use our cash in ways that add value to your investment, in an ineffective manner, or in a way that you do not approve of, and our management's failure to use those funds effectively could harm our business. Depending on usage, we may invest the net proceeds of this offering in short and medium-term interest-bearing notes, investment-grade instruments, certificates of deposit, or direct or guaranteed US Treasury bonds. These investments may not provide favorable returns for our shareholders. If we do not invest or use the net proceeds from this offering in a way that enhances shareholder value, we may not achieve the results anticipated, which could result in a decrease in our share price.

You will experience an immediate and significant dilution of the net tangible book value of the common shares purchased pursuant to this offering.

The IPO price of our common shares is substantially higher than the pro forma adjusted tangible net book value per share of our outstanding common shares immediately following the closing of this offering. Purchasers of common shares in this offering will experience immediate dilution of approximately $8.21 per share assuming an IPO price of $15.00 per share, which is the midpoint of the price range disclosed on the cover of this prospectus. In the past, we have issued options to purchase common stock at prices well below the initial public offering price. If these outstanding options are eventually exercised, investors who purchase common shares in this offering will experience additional dilution. A more detailed description of the dilution, which you will find out immediately after this offer, can be found under “Dilution”.

Pursuant to this offering, our officers, directors and principal shareholders, if they choose to act collectively, will continue to have the ability to significantly influence any matter submitted for shareholder approval and may prevent new investors from making important company decisions to influence.

Upon the closing of this offering, our officers, directors and greater than 5% of shareholders will collectively own approximately 61.9% of our outstanding common shares (assuming the underwriters' option to purchase additional shares is unexercised and no exercise options are outstanding and without effecting potential purchases by such persons in this offer). As a result, these individuals collectively have the ability to exercise significant influence on any matter submitted to our Board of Directors or our shareholders for approval, including the appointment of our management, the election and removal of directors, and the approval of all major transactions., as well as our management and business, which could prevent new investors from influencing some or all of the above. This concentration of ownership could result in delaying, deferring or preventing a change of control, preventing a merger, consolidation, acquisition or other business combination in which we are involved, or preventing a prospective acquirer from making a public offering or otherwise acquiring attempt to gain control of our business, even if such a transaction benefits other shareholders.

We do not currently intend to pay dividends on our common stock and accordingly your ability to obtain a return on your investment is dependent on the appreciation in the value of our common stock, if any.

We never declare or pay cash dividends on our common stock. We currently assume that we will retain future earnings in order to develop, operate and expand our business and we do not expect to pay any cash dividends in the foreseeable future. In addition, future debt agreements may prevent us from paying dividends. For the foreseeable future, therefore, any return to shareholders will be limited to the increase in the value of their shares. There is no guarantee that our common stock will match or match the price at which stockholders purchased their stock.

The sale of a significant number of our common shares by our existing shareholders in the public market could result in a decline in the price of our shares.

The sale of a significant number of our common stocks in the public market, or the expectation that such sales might occur, could materially decrease the market price of our common stock and impair our ability to raise adequate capital by selling additional stocks or units. linked titles.

Based on our common shares outstanding as of September 30, 2022, at the closing of this offering, we will have an aggregate of 37,056,653 common shares outstanding, subject to exercise of the underwriters' option to purchase additional shares and no exercise of outstanding stock options or warrants. Of these shares, only the 10,000,000 common shares sold by us in this offering, plus any shares sold upon exercise of the underwriters' option to purchase additional shares, will be freely tradable in the public market immediately following this offering. unless they are purchased by one of our subsidiaries.

Our directors and officers and holders of substantially all of our outstanding securities have entered into lock-up agreements with underwriters under which, with limited exceptions, they may not offer or sell or our for a period of 180 days from the date of this Prospectus Otherwise transfer or dispose of securities without the prior written consent of BofA, Evercore and Stifel. Underwriters may permit our officers, directors and other holders of securities subject to blocking agreements to sell shares at any time in their sole discretion prior to the expiration of the blocking agreements. See "Subscription". The sale of these shares, or the expectation that they will be sold, could cause the trading price of our common stock to decrease. Upon expiration of the lock-up agreements, up to 27,056,653 additional common shares will be admitted for sale in the public market, of which 22,935,128 shares will be held by directors, officers and other affiliated companies and are subject to the volume restrictions of Rule 144 of the Securities Act of 1933, as amended (the Securities Act), each based on the common shares outstanding as of September 30, 2022 and without effect of any potential purchases by such persons in this offering.

In addition, effective September 30, 2022, 1,320,932 common shares subject to outstanding options under our employee benefit plans will be admitted for sale on the public market, to the extent permitted under the terms of various vesting schedules. Up Agreements and Rule144 and Rule701 of the Securities Act. If these additional common shares are, or are expected to be, sold in the public market, the trading price of our common stock may decrease.

Pursuant to this offering, holders of 20,637,415 common shares outstanding, or approximately 55.7% of our total outstanding common shares, based on shares outstanding as of September 30, 2022, will have rights with respect to registration of their shares under the Securities Act, subject to the following Provisions Vesting and the 180-day lock-up agreements described above. See “Description of Share Capital – Registration Rights”. Registration of these shares under the Securities Act would result in the free trading of the shares without restriction under the Securities Act except for shares held by affiliated companies as defined in Rule 144 of the Securities Act. Any sale of securities by these shareholders could have a material adverse effect on the trading price of our common stock.

We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.

We are an Emerging Growth Company as defined by the JOBS Act and may remain an Emerging Growth Company through the last day of the financial year following the fifth anniversary of the completion of this Offering. However, if certain events occur before the end of that five-year period, including if we become a grand accelerated filer under the Securities Exchange Act of 1934, as amended (the Securities Exchange Act), our income will be equal to the annual gross debt of $1.235 billion $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company before the end of that five-year period. As long as we remain a growing, emerging company, we may and intend to rely on exceptions to certain disclosures.

Requirements applicable to public companies that are not Emerging Growth Companies. These exceptions include:

•permission to provide audited annual financial statements of only two years in addition to any required unaudited interim financial statements, with corresponding reduced disclosure of management's "discussion and review of financial condition and results of operations" in connection with offerings of registered securities;

•in assessing our internal control over financial reporting under the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley), not being required to meet the certification requirements for public accountants;

•not required to comply with requirements adopted by the Accounting Oversight Board of Listed Companies relating to the mandatory rotation of the audit firm or the supplementation of the auditor's report with additional information about the audit and the financial statements, unless the U.S. Securities and Exchange Commission (SEC) Finds New Rules Necessary to Protect Public;

•reduced disclosure requirements related to executive compensation; And

•Exceptions to the requirement to hold a non-binding consultative vote on executive compensation and shareholder approval of previously unauthorized Golden Parachute payments.

We take advantage of the reporting fee reduction in this prospectus. In particular, we only present audited financial statements for two years in this Prospectus and do not include all the information relating to executive compensation that would be required if we were not an emerging and growing company. We cannot predict that relying on these exceptions will make investors find our common stock less attractive. If this makes our common stock less attractive to some investors, there may be a less active trading market for our common stock and the price of our common stock may decline or be more volatile. In addition, the JOBS Act provides that an emerging and growing company may use an extended grace period to comply with new or revised accounting standards. This allows an emerging and growing company to defer adoption of these accounting standards until they apply to private companies. We have irrevocably elected to avail ourselves of this exception and as such may not be subject to the same new or revised accounting standards as other publicly traded companies that are not emerging growth companies. We intend to rely on other exceptions provided by the JOBS Act, including but not limited to failure to meet the certification requirements for public accountants under Section 404(b) of Sarbanes-Oxley.

We are also a minor reporting entity for the purposes of the Securities Markets Act. We can continue to be a smaller reporting company even though we are no longer an emerging growth company. We may use some of the sizing available to smaller reporting companies, and we may use those sizing as long as our voting and non-voting common stock held by unaffiliated companies is less than $250.0 million as measured on the last business day of our second fiscal quarter, or our annual income is less than $100.0 million during the most recently ended fiscal year and our unaffiliated voting and non-voting common stock is less than $700.0 million as of the last business day of our second fiscal quarter.

Provisions in our articles of incorporation and under Delaware law can discourage acquisitions that shareholders find favorable and lead to management entrenchment.

Our Amended and Restated Memorandum of Incorporation and Articles of Association, effective immediately prior to the consummation of this Offering, contain provisions that could materially decrease the value of our shares to a prospective acquirer or delay or prevent a change of control or changes in our Company Management without the approval of our board of directors. The provisions in our charter documents include the following:

•an orderly board of directors with staggered three-year terms, which may delay the ability of shareholders to change the composition of the majority of our board of directors;

•there is no cumulative voting in director elections, which limits the ability of minority shareholders to elect nominees for directors;

•the exclusive right of our board of directors, unless the board of directors grants the shareholders such a right to elect a director to fill a vacancy arising out of an enlargement of the board of directors or the resignation, death or removal of a Director has emerged, which precludes these shareholders from filling vacancies on our Board;

•requiring the approval of at least 66-2/3% of the voting shares to remove a director for cause and prohibiting the removal of directors without cause;

•the ability of our Board of Directors to authorize the issuance of preferred stock and to determine the price and other terms of such stock, including preferred and voting rights, without stockholder approval, which could be used to materially dilute ownership of an anti-corporate acquirer;

•the ability of our board of directors to change our amended and restated articles of association without obtaining shareholder approval;

•the required approval of not less than 66-2/3% of the voting shares to adopt, amend or rescind our amended and restated Articles of Incorporation or to repeal the provisions of our amended and restated Instrument of Incorporation relating to the election and removal of directors;

•a prohibition on shareholder action by written consent, requiring shareholder action to be taken at an annual or special meeting of our shareholders;

•an exclusive venue provision providing that the Delaware State Court of Chancery shall have exclusive jurisdiction over certain claims and proceedings;

•the requirement that an extraordinary meeting of shareholders be convened only by the board of directors, which may delay our shareholders' ability to compel consideration of any proposal or take any action, including the removal of directors; And

•Advance notice procedures that shareholders are required to follow to nominate candidates for our board of directors or to propose matters for consideration at a shareholders meeting, which may discourage or prevent a prospective acquirer from submitting a proxy request to elect the acquirer's representative establish their own list of directors or otherwise attempt to gain control of us.

We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporate Law. Section 203 generally prohibits a company from entering into a business combination with a holder of 15% or more of its common stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.

Our current amended and updated Articles of Incorporation provide, and our amended and updated Articles of Incorporation provides, that the Delaware State Court of Chancery will be the exclusive forum for substantially all disputes between us and our shareholders and that the federal district will be the exclusive forum for the resolution of claims alleging a cause of action under the Securities Act, which may limit our shareholders' ability to obtain a favorable forum for a dispute with us or our directors, officers or employees, or with the underwriters, or any offering of such claim justified.

Our current amended and updated Articles of Incorporation and our amended and updated Articles of Incorporation effective immediately prior to the consummation of this Offer provide that the Delaware State Court of Chancery shall be the exclusive forum for any derivative action or proceeding instituted on our behalf, any action, alleging a breach of fiduciary duty, any suit alleging a claim against us arising under the Delaware General Corporate Law, our amended and restated Instrument of Incorporation, or our amended and restated Articles of Association, or any action alleging a claim claims against us that it is governed by the doctrine of internal affairs; provided that this provision does not apply to actions to enforce an obligation or liability created by the Stock Exchange Act. In addition, where this is not the case, it will also be stated in our amended and updated Articles of Incorporation

written consent to the election of alternate venue, the federal district courts of the United States shall be exclusive venue for the resolution of any claim arising out of any cause of action arising out of the Securities Act. These choice of forum provisions may limit a shareholder's ability to bring a claim in a court of his or her convenience, regardless of any dispute arising between us or our directors, officers or other employees, arising out of such claims against us and our directors , Executives and others can discourage employees and lead to increased costs for investors to file a claim. However, by agreeing to this provision, shareholders will not be deemed to waive our compliance with the federal securities laws and their rules and regulations. In addition, the applicability of similar jurisdiction clauses in the articles of incorporation of other companies has been challenged in court proceedings, and it is possible that a court may find these types of clauses inapplicable or unenforceable. If a court decides that the jurisdiction clauses in our Amended and Consolidated Instrument of Incorporation are unenforceable or unenforceable in a lawsuit, we may incur additional costs associated with resolving such lawsuit in other jurisdictions, adversely affecting our business and financial health can affect .

General risk factors

As a result of being a public company, we will incur significant cost increases and our management will have to devote significant time to new compliance initiatives.

As a public company, we incur significant legal, accounting and other costs that we do not incur as a private company. We are subject to the reporting requirements of the Exchange Act, which requires, among other things, that we file annual, quarterly and current reports with the SEC regarding our business and financial condition. In addition, Sarbanes-Oxley, and later rules adopted by the SEC and Nasdaq to implement the Sarbanes-Oxley regulations, place significant requirements on publicly traded companies, including the requirement to establish and maintain effective disclosure and financial controls and certain corporate governance practices and practices. Additionally, under the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the SEC has passed additional rules and regulations in these areas, such as being an emerging and growing company. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may result in significant new regulations and disclosure requirements that may result in additional compliance costs and impact the way we anticipate conducting our business.

We anticipate that the rules and regulations applicable to public companies will significantly increase our legal and financial compliance costs and make some activities more time consuming and expensive. Increasing costs will reduce our net income or increase our net loss and could force us to reduce spending in other areas of our business or increase the prices of our products, if approved. For example, we anticipate that these rules and regulations will make it more difficult and expensive for us to obtain directors' and officers' liability insurance, and we could incur significant costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of any additional costs we may incur to comply with these requirements. The impact of these requirements may also make it difficult for us to attract and retain qualified individuals on our boards of directors, board committees or as executive officers. If these requirements divert the attention of our management and employees from other business matters, they could have a material adverse effect on our business, financial condition and results of operations.

We are subject to certain U.S. and foreign export and import controls, sanctions, embargoes, anti-corruption and money laundering laws and regulations. Compliance with these legal regulations could impair our competitiveness on national and international markets. We may be subject to criminal liability and other serious consequences for violations that could harm our business.

We are subject to export and import control laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs Regulations and various economic and trade sanctions regulations issued by the U.S. Office of Foreign Assets Controls. Department of the Treasury and Anti-Corruption and administers money laundering laws and regulations, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, of the U.S. Domestic Bribery Act in 18 U.S.C. Section 201, USA Travel Act, USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries where we do business. Anti-corruption laws are interpreted broadly and prohibit corporations and their employees, agents, CROs, contractors and other employees

and prevent partners from directly or indirectly authorizing, promising, offering, providing, soliciting, or receiving any improper payment or other thing of value to recipients in the public or private sector. We may contract with third parties for clinical trials outside of the United States, sell our products abroad if and when we enter a commercialization phase, and/or obtain authorizations, licenses, patent applications and other necessary regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or hospitals, universities and other government-related organizations. We may be held liable for corruption or other unlawful activities by our employees, agents, CROs, contractors and other employees and partners, even if we do not expressly authorize or have actual knowledge of such activities and training or compliance programs or other initiatives we undertake us to avoid such activities which may not be effective. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, loss of export or import privileges, foreclosures, tax reassessments, breach of contract and fraud proceedings, damage to reputation, and other consequences.

In addition, US export control laws and economic sanctions prohibit the supply of certain products and services to US-sanctioned countries, governments and individuals. US sanctions that have been or may be imposed in other countries due to military conflicts may affect our ability to continue our activities at future clinical trial sites in regions affected by such sanctions. If we fail to comply with export and import regulations and such economic sanctions, penalties, including fines and/or denial of certain export privileges, may be imposed. These export and import controls and economic sanctions could also adversely affect our supply chain.

Our manufacturers or third party suppliers may use strong chemical agents and hazardous materials and any complaint related to improper handling, storage or disposal of these materials can be time consuming or costly.

Our third party manufacturers or suppliers use and potential future employees will use biological materials, strong chemical agents and potentially hazardous materials, including chemicals and biological agents and compounds that may be hazardous to human health and environmental safety. The operations of our third party manufacturers and suppliers also produce hazardous waste. Federal, state, and local laws and regulations govern the use, generation, manufacture, storage, handling, and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations can be costly, and current or future environmental laws and regulations may hamper our product development efforts. In addition, our third-party manufacturers and suppliers cannot eliminate the risk of accidental injury or contamination from these materials or waste. We do not have specific insurance coverage for biological or hazardous waste, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines resulting from contact with or contamination with biological or hazardous waste. In the event of contamination or injury at our manufacturers' or suppliers' facilities, we may be liable for damages or fines that exceed our resources, and our clinical trials or regulatory approvals may be suspended. Although we maintain workers' compensation insurance to cover certain costs and expenses that we may incur as a result of work-related injuries suffered by our employees, this insurance may not provide adequate protection against potential liabilities. We do not maintain insurance for civil liability claims that may be brought against us in connection with the storage or disposal of biological, hazardous or radioactive materials by our third party manufacturers and suppliers.

In addition, our third-party manufacturers and suppliers may incur significant costs to comply with current or future environmental, health and safety laws and regulations, which are likely to become more stringent over time, which may increase the cost of their services. for us. These current or future laws and regulations could harm our research, development, or manufacturing efforts. Failure to comply with these laws and regulations could also subject our third-party manufacturers and suppliers to significant fines, penalties or other sanctions or liabilities, which in turn could adversely affect our business, financial condition, results of operations and prospects. To the extent that we develop our own manufacturing operations in the future, we may incur significant costs to ensure compliance with these laws, and all of the foregoing risks apply to us as well.

Business disruptions could seriously affect our future revenues and financial condition and increase our costs and expenses.

Our operations and the operations of our suppliers, CROs, CMOs, and clinical facilities may be subject to earthquakes, power outages, telecommunications or infrastructure failures, cybersecurity incidents, and physical damage

Security breaches, water shortages, floods, hurricanes, typhoons, snowstorms and other extreme weather conditions, fires, public health pandemics or epidemics (including, for example, the COVID-19 pandemic) and other natural or man-made disasters and business interruptions, for which we mostly insure ourselves are. We rely on third-party manufacturers or suppliers to manufacture lorundrostat and its components, CROs and clinical sites to conduct our clinical studies, and we do not have a redundant source of supply for all components of our candidate product. Our ability to receive clinical or, if approved, commercial supplies of lorundrostat or a future product candidate could be disrupted if the operations of those suppliers are adversely affected by a natural or man-made disaster or other business disruption, and our ability to initiate or The timely completion of our clinical trials could be impacted by any of the above. The occurrence of any of these business disruptions could seriously affect our operations and financial condition and increase our costs and expenses.

Unstable economic and market conditions could have serious adverse consequences for our business, financial condition and stock price.

Global financial and credit markets have recently experienced extreme volatility and disruption, including sharply reduced liquidity and credit availability, falling consumer confidence, slowing economic growth, rising unemployment rates and uncertainty about economic stability. Financial markets and the global economy could also be adversely affected by the current or anticipated effects of a military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events. Sanctions imposed by the United States and other countries in response to such conflicts, including Ukraine, could also adversely affect financial markets and the global economy, and any economic countermeasures by affected countries or others could exacerbate market and economic instability . There is no guarantee that financial and credit markets and confidence in economic conditions will not deteriorate further. Our overall business strategy could be adversely affected by an economic downturn, a volatile business environment, or unpredictable and unstable market conditions. If current equity and credit markets deteriorate, it could make necessary debt or equity financing more difficult, expensive and dilutive. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price, and could force us to delay, limit, reduce or discontinue our product development or future commercialization efforts or rights to develop and commercialize our product candidates, even if we prefer to develop and commercialize such candidates ourselves or on terms less favorable than those chosen by us. Additionally, if one or more of our current service providers, manufacturers and other partners fail to survive an economic downturn, this could directly impact our ability to meet our clinical development goals on schedule and within budget.

Changes in tax laws could adversely affect our financial condition, results of operations and cash flows, or affect the value of an investment in our common stock.

Any new income, sales, use or other law, statute, rule, regulation or ordinance may be enacted or interpreted, changed, modified or adversely applied to us at any time which could adversely affect our business operations and financial performance. We encourage our investors to consult their legal and tax advisors regarding any changes in tax laws and the potential tax consequences of an investment in our common stock.

If securities or industry analysts do not publish analysis or reports, or publish unfavorable analysis or reports about our business, our stock price and trading volume could decrease.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us, our business, our market or our competitors. We are currently unable and never will be able to obtain research reports from securities and industry analysts. If no securities or industry analysts initiate coverage of our company, the trading price of our stock will be adversely affected. In the event that securities or industry analysts report on us, if one or more of the analysts covering us downgrades our stock, or if we fail to meet the expectations of one or more of those analysts, our stock price is likely to fall. If one or more of these analysts stops covering us or issuing regular reports about us, interest in our stock could decrease, which could cause our share price or trading volume to decrease.

If we do not maintain adequate and effective internal control over financial reporting, our ability to prepare accurate and timely financial reports could be impaired, investors could lose confidence in our financial reporting, and the trading price of our common stock could decrease.

Section 404 of Sarbanes-Oxley requires our management to report on the effectiveness of our internal control over financial reporting beginning with the annual report for our year ended December 31, 2024. If we qualify as our “emerging growth company” rather than “small reporting company” with annual sales of less than $100 million, our independent registered public accounting firm must certify the effectiveness of our internal control over financial reporting. The rules for the standards that our management must meet to assess our internal control over financial reporting are complex and require extensive documentation, testing and possible correction. In order to meet reporting company requirements under the Stock Exchange Act, we may need to update our information technology systems; implement additional financial and managerial controls, reporting systems and procedures; and hire additional accounting and finance staff. If we, or if required, our auditors are unable to conclude that our internal control over financial reporting is effective, investors could lose confidence in our financial reporting and the trading price of our common stock could decrease.

We cannot assure you that there will be no material weaknesses or material deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could seriously affect our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent audit firm determines that we have a material weakness or deficiency in our internal control over financial reporting, after this company has commenced its Section 404 review, investors could lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the Nasdaq, SEC or other regulatory authorities. Failure to address significant weaknesses in our internal control over financial reporting or to implement or maintain other effective controls required of publicly traded companies could also limit our future access to capital markets.

We may be the subject of securities class actions.

In the past, securities class actions have often been brought against a company after the market price of its securities has fallen. This risk is particularly relevant to us as biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years. If we are faced with such litigation, even if it is decided in our favor, it could result in significant costs and a distraction of our management's attention and resources, which could harm our business.

SPECIAL NOTICE REGARDING FORWARD STATEMENTS

This prospectus contains forward-looking statements about us and our industry. All statements, other than historical facts, contained in this prospectus, including statements about our future results of operations and financial position, business strategy, research and development plans, anticipated timing, costs, design and conduct of our ongoing preclinical studies and planned clinical studies for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates if approved, the impact of the COVID-19 pandemic on our business, the pricing and reimbursement of our product candidates if approved, the potential for developing future product candidates, the potential benefits of strategic collaborations and our intent to enter into strategic agreements, the timing and likelihood of success performance and management's plans and objectives, future operations and future results from anticipated product development efforts are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by using words such as "may", "will", "should", "expect", "plan", "anticipate", "could", "intend", "target", "projected". , "considers," "believes," "estimates," "anticipates," "enables," or "continues," or the negative of such terms, or other similar expressions. The forward-looking statements contained in this prospectus are only predictions. We base these forward-looking statements largely on our current expectations and projections about future events, financial and other trends that we believe could affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Prospectus and are subject to various risks, uncertainties and assumptions, which are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections and elsewhere in this Prospectus. Because forward-looking statements inherently involve risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not materialize or occur, and actual results may differ materially from those projected in the forward-looking statements. In addition, we operate in an evolving environment. New risk factors and uncertainties may arise from time to time and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise. However, you should review the factors and risks, which we describe in reports we periodically file with the SEC after the date of this prospectus. See the Where to Find More Information section.

In addition, "believe" statements and similar qualifying statements reflect our beliefs and opinions on the matter at hand. These statements are based on information available to us as of the date of this Prospectus and while we believe this information provides a reasonable basis for such statements, such information may be limited or incomplete and our statements should not be read as such that this is the case, a thorough investigation or review of all potentially available relevant information is carried out. These statements are inherently uncertain and you are cautioned not to place undue reliance on them.

MARKET AND INDUSTRY DATA

We obtained the industry, market and competitive positioning data used in this prospectus from our own estimates and internal research, as well as from independent market research, general and industry-specific publications and research, government agencies and publicly available information, and surveys, surveys and studies conducted by third parties. The content of these third party sources, except to the extent expressly provided in this Prospectus, does not form part of this Prospectus and is not included herein. Internal estimates are derived from publicly available information published by industry analysts and third party sources, our internal research and industry experience, and are based on assumptions we have made based on that data and what we believe to be our knowledge of our industry and market to be reasonable. In some cases, we do not explicitly identify the sources from which this data came. Accordingly, where we refer in a paragraph to one or more sources of that type of data, you must assume that other data of that type appearing in the same paragraph comes from the same sources, unless expressly stated otherwise or the context otherwise requires .

While we are responsible for all disclosures contained in this prospectus and believe that the industry, market and competitive position data contained in this prospectus is reliable and based on reasonable assumptions, such data involves risks and uncertainties and is subject to change based on various factors, including , discussed in the “Risk Factors” and “Special Note Regarding Forward-Looking Statements” sections. These and other factors could cause results to differ materially from estimates made by independent parties or by us. Certain monetary amounts, percentages and other amounts included elsewhere in this Prospectus have been subject to rounding adjustments. Therefore, values ​​presented as totals in certain tables or charts may not be the arithmetic sum of the numbers preceding them, and values ​​expressed as percentages in the text may not add up to 100% or, as the case may, when aggregated, may not be the arithmetic sum of the percentages that precede them.

USE OF PROCESSES

We estimate that the net proceeds from this offering will be approximately $136.2 million (or approximately $157.1 million if the underwriters exercise their option to purchase additional shares in full), assuming an initial public offering price of $15.00 per share at the midpoint of the price range shown on the cover of this prospectus and after deduction of estimated underwriting discounts and commissions and estimated offering costs payable by us.

Any increase or decrease of $1.00 in the estimated initial issue price of $15.00 per share, which is the midpoint of the estimated price range disclosed on the cover of this prospectus, would increase or decrease the net proceeds to us from approximately $9.3 million in this offering, assuming that the number of shares we are offering as set forth on the cover of this prospectus remains the same and after deduction of estimated offering discounts and commissions and estimated Quotation costs to be paid by us. An increase or decrease in the number of common shares we are offering by 1.0 million shares would increase or decrease the net proceeds to us from this offering, after deducting estimated subscription discounts and fees and estimated offering costs from the costs to be paid by us, at approximately $14.0 million, assuming assumed IPO price remains the same. The information discussed above is for illustrative purposes only and will be adjusted based on the actual IPO price and other terms of this offering set out in the pricing.

We estimate that as of December 31, 2022 we had cash, cash equivalents and marketable securities of approximately $110.4 million. This estimate was made by management in good faith based on internal reporting, is preliminary and unaudited, and is subject to revision due to management's further review of our results as of and for the year ended 31 December 2022. We have not yet completed our normal audit procedures as of and for the year ended December 31, 2022.

The primary purpose of this offering is to raise additional capital to support our operations, create a public market for our common stock, and facilitate our future access to public stock markets. We intend to use approximately $122 million of the net proceeds from this offering, along with our existing cash, cash equivalents and marketable securities, to fund research and development of lorundrostat and the balance for working capital and general corporate purposes.

We may also use a portion of the remaining net proceeds and our existing cash, cash equivalents and marketable securities to license, acquire or invest in complementary companies, technologies, products or assets. However, we currently have no commitments or commitments in this regard.

Based on our current plan of operations, we believe that the net proceeds from this offering, together with our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operations for at least 18 months from the date of this prospectus. In particular, we expect that the net proceeds from this offering, together with our existing cash, cash equivalents and marketable securities, will allow us to report key data from our planned Phase 2 study evaluating lorundrostat for the treatment of uHTN and rHTN, if used as add-on therapy to background antihypertensive medications and our planned phase 2 study evaluating lorundrostat for the treatment of uHTN and rHTN in a population with CKD. We base these estimates on assumptions that may be incorrect and we may deplete our capital resources sooner than we currently expect. In addition, our anticipated use of existing cash, cash equivalents and marketable securities and our net proceeds from this offering represent our intentions based on our current business plans and conditions, which may change in the future as our plans and business conditions evolve. The amount and timing of our actual expenditures may vary significantly depending on a number of factors, including the progress and costs of our development activities, the status and results of clinical trials and pre-clinical studies, and any collaborations we may enter into with third parties for lorundrostat and any future product candidates, and the amount of cash to be used in our operations and any unforeseen cash requirements, as well as other factors described in the sections of this prospectus entitled “Risk Factors”, “Management's Discussion and Analysis” and Financial and results of operations" and "Special note on forward-looking statements". We require significant capital to advance Lorundrosta and any future product candidates through clinical trials, regulatory approvals and commercialization. Until then, if ever

Because we can generate significant revenue from products, we expect to meet our liquidity needs through equity offerings, debt financing or other sources of capital, including potential collaborations, licensing and other similar arrangements. However, we may not be able to raise additional funds or enter into such arrangements on favorable terms or at all, as appropriate.

Our management will use its discretion in allocating the net proceeds of this offering and investors will rely on our management's judgment in allocating such net proceeds. The timing and amount of our actual expenditures are based on many factors, including cash flows from operations and anticipated growth of our business. Depending on the intended uses outlined above, we plan to invest the net proceeds in a variety of capital preservation vehicles, including short-term interest-bearing notes, investment-grade instruments, certificates of deposit, and US direct or guaranteed bonds.

DIVIDEND POLICY

We never declare or pay cash dividends on our share capital. We currently intend to retain any future profits to fund our operations and we do not expect to be able to distribute any cash dividends on our common stock in the foreseeable future. All future decisions regarding our dividend policy will be made at the discretion of our Board of Directors after consideration of our financial condition, results of operations, current and anticipated capital requirements, business prospects and other factors that our Board of Directors believes to be relevant and subject to applicable laws and the restrictions contained in future financing instruments.

CAPITALIZATION

The following table shows our cash, cash equivalents and marketable securities and capitalization as of September 30, 2022:

•on an actual basis;

•on a pro forma basis, to (i) the automatic conversion of all outstanding shares of our convertible preferred stock into 20,637,415 shares of our common stock and the related reclassification of the carrying amount of the convertible preferred stock to permanent equity immediately prior to the closing of this offering and (ii ) the filing and effectiveness of our Amended and Consolidated Memorandum of Incorporation immediately prior to the closing of this Offering; And

•on a pro forma basis, adjusted to give more effect to our issuance and sale of 10,000,000 common shares in this offering at a deemed offering price of $15.00 per share, the midpoint of the price range disclosed on the front page of this prospectus, less estimated subscription discounts and fees and estimated offering costs payable by us.

The pro forma and pro forma information adjusted below is for illustrative purposes only and our cash, cash equivalents and marketable securities and capitalization upon the closing of this offering will be adjusted based on the actual offering price and other terms of this offering set forth in became prizes. You should read this information in conjunction with our financial statements and related notes contained in this Prospectus and the section entitled “Disclosure and Analysis of Management's Financial Condition and Results of Operations” and other financial information contained in this Prospectus.

___________________

(1)Any increase or decrease of $1.00 in the prospective IPO price of $15.00 per share, which is the midpoint of the price range shown on the cover of this prospectus, would increase or decrease the form as an adjusted value of each of our Cash, cash equivalents and marketable securities, additional paid-up capital, total equity (deficit) and total capitalization at approximately $9.3 million, assuming the number of shares we are offering as set out on the front page of this document The prospectus remains after deducting estimated underwriting discounts and fees and estimated offering costs payable by us. Each 1.0 million share increase or decrease in the number of shares we are offering at the deemed IPO price of $15.00 per share would increase or decrease the pro forma adjusted value of each of our cash, cash equivalents and marketable securities

Securities, additional paid-up capital, total equity (deficit) and total capitalization of approximately $14.0 million, after deducting estimated subscription discounts and fees and estimated issuing costs payable by us.

If the underwriters' option to purchase additional shares is exercised in full, our pro forma value of adjusted cash, cash equivalents and marketable securities, additional paid-up capital, total equity (deficit) and total capitalization as of September 30, 2022 would be US$278.2 million -dollars, $316.1 million, $272.4 million and $272.4 million, respectively.

The number of common shares outstanding pursuant to this offering described above is based on the 27,056,653 common shares outstanding as of September 30, 2022, including 1,228,075 shares subject to forfeiture or our right of repurchase after the automatic conversion of all shares outstanding to our Preferred Shares convertible into 20,637,415 Common Shares immediately prior to the closing of this Offering and excludes:

•1,320,932 common shares to be issued upon exercise of stock options outstanding on September 30, 2022 at a weighted average exercise price of $0.91 per share;

•1,071,935 shares of our common stock issuable upon exercise of the IPO concessions related to this offering under the 2023 Plan, which becomes effective in connection with this offering, to certain of our employees and directors at an exercise price equal to the IPO price in this offering;

•4,650,000 common shares reserved for future issuance under the 2023 Plan (this number including the IPO grants but excluding potential multi-year increases under the terms of the 2023 Plan); And

•400,000 common shares reserved for future issuance pursuant to our 2023 Employee Stock Purchase Plan (the ESPP), which becomes effective in connection with this offering (this figure excluding potential multi-year increases under the terms of the ESPP).

DILUTION

If you invest in our common stock pursuant to this offering, your equity interest will be immediately and substantially diluted by the difference between the per share IPO price and the pro forma adjusted net book value per share of our common stock immediately thereafter such offering.

As of September 30, 2022, our historical tangible net book value (deficit) was $(43.4) million or ($6.76) per share of our common stock based on 6,419,238 issued and outstanding common shares on that date, inclusive 1,228,075 shares are subject to expiry or our right of repurchase from this date. Our historical tangible net book value (deficit) per share represents total tangible assets less total liabilities and convertible preferred stock not included in permanent equity divided by the number of common shares outstanding as of September 30, 2022.

On a pro forma basis, upon completion of the automatic conversion of all outstanding shares of our convertible preferred stock into 20,637,415 shares of our common stock and related reclassification of the carrying amount of the convertible preferred stock to permanent equity immediately prior to the closing of the Under Post Offering, our substantive Pro forma net book value (deficit) as of September 30, 2022 was approximately $115.2 million, or approximately $4.26 per share of our common stock.

Upon completion of the sale of 10,000,000 common shares pursuant to this offering at an assumed IPO price of $15.00 per share, being the midpoint of the price range set forth on the cover of this prospectus, and after deduction and estimated subscription fees and estimated fees payable by us Offering costs, our pro forma tangible net book value as of September 30, 2022 would have been approximately $251.4 million, or approximately $6.79 per share. This amount represents an immediate increase in pro forma tangible net book value of approximately $11.02 per share for our existing shareholders and an immediate dilution of pro forma tangible net book value of approximately $8.21 per share for new investors who are Purchase common shares in this offering.

Per-share dilution for new investors will be determined by subtracting the pro forma adjusted net book value per share following this offering from the per-share IPO price paid by new investors. The table below illustrates this dilution (without the subscribers exercising their option to purchase additional shares):

Any increase or decrease of $1.00 in the deemed IPO price of $15.00 per share, which is the midpoint of the price range disclosed on the cover of this prospectus, would increase the pro forma pro forma book value thereafter adjusted as per share or reduce the offering to approximately $0.25 per share and pro forma dilution as adjusted tangible net book value per share to new investors to approximately $0.75 per share, assuming the number of shares we are offering as on the front page stated in this Prospectus remains the same after deducting any estimated underwriting discounts and fees and estimated offering costs payable by us. Each increase or decrease in the number of common shares we are offering by 1.0 million shares would increase or decrease our pro forma adjusted tangible net book value per share after this offering by approximately $0.20 per share and dilution for the an Investors participating in this offering decrease or increase by approximately $0.20 per share, assuming the assumed offering price of $15.00 per share remains in place

the same and less the estimated subscription discounts and commissions and the estimated cost of gifts payable by us.

If the underwriters exercise in full their option to purchase additional shares of our common stock in this offering, the post-offering adjusted pro forma tangible book value per share would be approximately $7.06 per share, the pro forma increase in adjusted tangible net book value per share for existing shareholders would be approximately $13.83 per share and per share dilution for investors in this offering would be $2.80 per share, each assuming an IPO price of $15.00 per share, which is the midpoint of the stated price range cover sheet of this prospectus.

The above dilution information is for illustrative purposes only. Our adjusted pro forma net book value upon closing of this offering will depend on the actual IPO price and other terms of this offering set out in the pricing.

The following table summarizes, on a pro forma basis as described above, as of September 30, 2022, the differences between the number of shares we have purchased, the total cash consideration paid to us and the average price per share paid by existing shareholders. for shares issued prior to this offering and the price to be paid by new investors under this offering. The calculations below are based on an assumed IPO price of $15.00 per share, the midpoint of the price range stated on the cover of this Prospectus, gross of any estimated offering rebates and fees and estimated offering costs payable by us.

If subscribers exercise their option to purchase additional shares of our common stock in full:

•the percentage of common shares held by existing shareholders following this offering will decrease to approximately 70% of the total number of common shares outstanding; And

•The number of shares held by new investors participating in this offering will increase to 11,500,000 shares, or approximately 30% of the total number of common shares outstanding following this offering.

The above tables and calculations (excluding historical calculations of tangible net book value) are based on 27,056,653 common shares outstanding as of September 30, 2022, including 1,228,075 shares that are subject to expiry or our right of repurchase after the automatic conversion of all outstanding shares to Shares of our convertible preferred stock 20,637,415 common shares became effective immediately prior to the closing of this offering and excluding:

•1,320,932 common shares to be issued upon exercise of stock options outstanding on September 30, 2022 at a weighted average exercise price of $0.91 per share;

•1,071,935 shares of our common stock issuable upon exercise of the IPO concessions related to this offering under the 2023 Plan, which becomes effective in connection with this offering, to certain of our employees and directors at an exercise price equal to the IPO price in this offering;

•4,650,000 common shares reserved for future issuance pursuant to the 2023 plan, which becomes effective in connection with this offering (this number includes the IPO grants but excludes potential multi-year increases under the terms of the 2023 plan); And

•400,000 common shares reserved for future issuance under the ESPP, which becomes effective in connection with this offering (this number not including potential multi-year increases under the terms of the ESPP).

To the extent that outstanding options are exercised, new options or other stock awards are issued under our stock incentive programs, or we issue additional shares or convertible debentures in the future, there will be further dilution for new investors participating in this offering.

MANAGEMENT MEETING AND ANALYSIS OF THE FINANCIAL AND EARNINGS SITUATION

overview

We are a clinical-stage biopharmaceutical company focused on developing drugs to treat diseases caused by abnormally elevated aldosterone. Our product candidate lorundrostat is a highly selective, orally administered aldosterone synthase inhibitor (ASI) that we are initially developing for the treatment of patients with uncontrolled (uHTN) or resistant (rHTN) hypertension. There are more than 115 million patients with sustained hypertension (BP), or hypertension, in the United States, and more than half of this population is unable to meet their blood pressure goals, defined as blood pressure below 130/80 mmHg, using the Resources currently available drugs. There are more than 30 million treated patients who do not reach their blood pressure goal, of whom approximately 20 million have systolic blood pressure readings above 140 mmHg. Patients with high blood pressure that persists despite taking two or more medications are 1.8 and 2.5 times more likely to die from cardiovascular disease and stroke, respectively. In a phase 2 clinical study in 200 subjects with uHTN and rHTN (Target-HTN), lorundrostat demonstrated clinically and statistically significant reductions in blood pressure with once-daily dosing and was well tolerated. In addition to hypertension, we intend to develop lorundrostat for the treatment of chronic kidney disease (CKD) and believe that our product candidate promises to be an innovative solution to the growing unmet need in various cardiovascular diseases.

We plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in the first half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to baseline treatment of two or three antihypertensive drugs in up to about 240 adults. Key data from this study is expected in the first half of 2024. We also plan to initiate a phase 3, randomized, double-blind, placebo-controlled study in the second half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to background treatment with two or more antihypertensive drugs in up to about 1,000 adults. The study is expected to have a similar design to the planned Phase 2 study. Main data from this study are expected in mid-2025.

Lorundrostat was designed to normalize aldosterone production and we believe this mechanism could be applied to other indications where abnormal aldosterone biology plays a role. We plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN in a population with CKD, with pivotal data expected from this study in the first half of 2024 .

Uninhibited aldosterone is known to play a critical role in the progression of CKD, which affects more than 23 million people in the United States. In addition, we can expand the development of lorundrostat to other cardio-renal indications.

We commenced operations in May 2019 and so far essentially all of our resources have been devoted to organizing and commissioning our business, business planning, raising capital, licensing our product candidate Lorundrostat, building our intellectual property portfolio, conducting research, preliminary testing, etc .expended clinical trials and provided other general and administrative support to our operations. As of September 30, 2022, we had cash, cash equivalents and marketable securities of $121.0 million. From inception through September 30, 2022, we have received aggregate gross proceeds of approximately $158 million from the issuance of convertible debentures (the "Convertible Debentures") and convertible preferred stock.

We have no products approved for sale, we generate no revenue and we have suffered a net loss to begin with. Our previous activities were limited to business planning, raising capital, licensing and development of lorundrostat, conducting clinical trials and other research and development activities. Our net losses for the years ended December 31, 2020 and 2021 were $3.4 million and $19.4 million, and $12.3 million and $20.7 million for the nine months, respectively as of September 30, 2021 and 2022. As of December 31, 2021 and September 30, 2022, we had an accumulated deficit of $23.0 million and $43.7 million, respectively. Our net losses can vary significantly from quarter to quarter and from year to year depending on the timing of our clinical development and other research and development activities. We hope our spending

and operating losses will increase significantly as we conduct our ongoing and planned clinical trials for lorundrostat, potentially obtain regulatory approval for lorundrostat and any future product candidates we develop, expand our clinical, regulatory, qualitative, manufacturing and commercialization activities, maintain, protect and enforce our intellectual property, expand our general and administrative support functions, including hiring additional staff, and additional costs associated with operating as a public company.

Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities, together with the estimated net proceeds from this offering, will be sufficient to support our anticipated cash needs for at least the next 18 months. We have never generated any revenue and do not anticipate any revenue from product sales unless we have successfully completed development and received regulatory approval for lorundrostat, which will take several years, if at all. Therefore, until such time as we are able to generate significant proceeds from the sale of Lorundrostat, we expect to meet our liquidity needs through equity offerings, debt financing or other sources of capital, including potential collaborations, in-licensing and other similar arrangements. However, we may not be able to raise additional funds or enter into such arrangements on favorable terms or at all, as appropriate. Our failure to raise capital when needed or to enter into such arrangements would adversely affect our financial condition and could force us to delay, limit, reduce or discontinue our future product development or commercialization efforts or be granted rights to develop and commercialize candidate products grant. that we would otherwise prefer to develop and market. For more information, see "liquidity and capital resources.”

The global COVID-19 pandemic is evolving and we will continue to closely monitor the COVID-19 situation. We have not experienced any significant impact from the COVID-19 pandemic to date; However, the extent of the impact of the COVID-19 pandemic on our business, operations and clinical development schedules and plans remains uncertain and will depend on certain developments, including their impact on our clinical trial enrollment, study sites, manufacturers, CROs and other third parties with whom we do business and their impact on regulators and our key scientific and administrative staff. The ultimate impact of the COVID-19 pandemic, including the impact of new variants of the virus that causes COVID-19 or any similar public health pandemic, is highly uncertain and subject to change. Where possible, we are continuing our business as usual, with necessary or advisable changes to employee travel and the majority of our employees working from home. We will continue to actively monitor the evolving situation related to COVID-19 and may take other actions that alter the way we operate our business, including those required by federal, state, or local authorities or that we, in our sole discretion, consider to be in the best interests of our employees lie and other third parties with whom we do business. At this time, the extent to which the COVID-19 pandemic may affect our business, operational and development plans and plans, including the resulting impact on our spending and capital requirements, remains uncertain and is subject to change.

License agreement with Mitsubishi Tanabe

In July 2020, we entered into a license agreement (the Mitsubishi License) with Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe), under which Mitsubishi Tanabe granted us an exclusive, worldwide, royalty-free, sublicensable license under Mitsubishi Tanabe's patent and other intellectual Proprietary rights to use products containing Lorundrostat (formerly MT-4129) (Lorundrostat Products) for the prevention, treatment, diagnosis, detection, monitoring or predisposition testing of any indication, disease or condition in humans. We are paying Mitsubishi Tanabe an initial fee of US$1.0 million and are required to make development milestone payments of up to Mitsubishi Tanabe$9.0 milliontotal and commercial milestone payments of up to$155.0 millionaggregated upon first commercial sale and upon achievement of certain annual sales targets and additional commercial milestone payments of up to$10.0 millionfor a second appointment. In addition, we have to pay increasing royalties to Mitsubishi Tanabe in the mid-single-digit percentage rangeten percent(10%) of the aggregate net sales of each Lorundrostat Product in a Lorundrostat Product by Lorundrostat Product and country by country, until the last of (i) expiry of Mitsubishi Tanabe's last valid patent claim covering a Lorundrostat Product, (ii) ten years upon first commercial sale of a Lorundrostat product or (iii) expiration of regulatory exclusivity in that country. These royalties can be reduced under certain conditions, including lack of patent coverage and generic competition.

We are committed to using commercially reasonable efforts to undertake and complete development activities and seek regulatory approval for at least one lorundrostat product in a country with an important market

consider in good faith to develop at least one lorundrostat product in a country with a non-large market. If we sub-license our rights under the Mitsubishi license to use Lorundrostat or a Lorundrostat product in certain countries in Asia to a third party, Mitsubishi Tanabe will have the right of first sale for a specified period of time. We also agree not to market any competing product for a period of three years after the first commercial sale of the first Lorundrostat product in any country without Mitsubishi Tanabe's prior consent. For more information on the Mitsubishi License, including termination provisions, see "Business - Intellectual Property - License Agreement with Mitsubishi Tanabe".

Main components of the earnings situation

operating cost

Research and Development

Research and development costs consist primarily of external and internal costs related to the development of lorundrostat. Research and development costs are recognized when incurred and payments made before goods or services are received for use in research and development are capitalized until the goods or services are received.

Research and development costs include:

•salaries, bonuses, employee benefits and stock-based compensation for individuals involved in research and development efforts;

•external research and development costs incurred under arrangements with contract research organizations (CROs) and consultants to conduct and support our lorundrostat clinical trials and payments under the Mitsubishi license; And

•Costs associated with manufacturing lorundrostat for our clinical trials.

We plan to significantly increase our research and development costs for the foreseeable future as we continue to develop lorundrostat. We cannot with certainty determine the timing of initiation, duration, or cost of completion of current or future clinical and preclinical studies of lorundrostat or future product candidates due to the unpredictable nature of clinical and preclinical development. Clinical and preclinical development times, probabilities of success and development costs can deviate significantly from expectations. In addition, we cannot predict whether lorundrostat or future product candidates will be the subject of future collaborations, when such agreements may be entered into, and how such agreements would affect our development plans and capital requirements.

Our future development costs may vary significantly based on factors such as:

•the initiation, nature, number, scope, progress, extensions, results, costs and timing of clinical and preclinical studies of lorundrostat and any future product candidates we may select, including any changes to clinical development plans based on feedback we may receive from regulatory authorities;

•our ability and strategic decision to develop future product candidates beyond lorundrostat and the timing of such development, if any;

•our ability to receive timely regulatory approvals for lorundrostat, any future product candidates and additional indications for lorundrostat and any future product candidates in the jurisdictions in which we or prospective partners are seeking such approvals;

•the cost and time to manufacture lorundrostat or future product candidates for use in our studies, including as a result of inflation, supply chain issues or component shortages;

•any additional jurisdictions in which we are seeking regulatory approval for lorundrostat and any future product candidates and the timing of filing for regulatory approval in those jurisdictions;

•patient dropout or dropout rates from clinical trials;

•potential additional security monitoring requested by regulatory authorities;

•length of patient participation in studies and follow-up;

•the development phase of the product candidate;

•the impact of any disruption to our operations or the operations of third parties we work with due to the ongoing COVID-19 pandemic;

•the efficacy and safety profile of each product candidate; And

•the extent to which we have entered into strategic collaborations or other agreements.

General and administrative expenses

General and administrative expenses consist primarily of personnel-related costs, including employee salaries, bonuses, benefits and stock-based compensation, for personnel in managerial and administrative functions. Other significant general and administrative expenses include intellectual property and corporate attorneys' fees, accounting, tax and consulting fees, and insurance costs. We anticipate that our general and administrative expenses will increase for the foreseeable future to support our growing research and development activities, manufacturing activities and increased costs associated with operating as a public company. These increased costs are likely to include increased expenses associated with hiring additional personnel, auditing, legal, regulatory and tax services related to maintaining compliance with the Stock Exchange listing and the Securities and Exchange Commission (SEC) requirements and requirements of Sarbanes-Oxley include 2002 (SOX), insurance costs for directors and officers, and public relations and investor costs.

Other income (expense), net

Interest income (expense)

Interest income in 2022 is associated with our investments in money market funds and US Treasuries. Interest expense in 2021 consisted of interest on our outstanding convertible debentures, described below, prior to their conversion into shares of our Series A convertible preferred stock in February 2021.

Change in fair value of convertible bonds

We issued convertible bonds in 2019 and 2020 for which we elected the fair value option. We adjust the carrying amount of our convertible bonds to their estimated fair value at each balance sheet date, with any change in the fair value of the convertible bonds being accounted for as an increase or decrease in the change in fair value of the convertible bonds in our financial statements of operations. All outstanding convertible debentures and related interest accrued were converted into shares of our Series A Convertible Preferred Stock in February 2021.

operating results

Comparison of the fiscal years ended December 31, 2020 and 2021

research and development costs

Research and development expenses increased by $13.9 million for the year ended December 31, 2021 compared to the year ended December 31, 2020 primarily due to an increase of $11.6 million in related pre-clinical and clinical costs with research and development of lorundrostat, a US$1.7 million increase in personnel costs on hiring additional employees in 2021 to support research and development, and a US$1.6 million increase in clinical supplies, manufacturing and regulation Dollar.

We acquired the licensed rights to lorundrostat in July 2020 and initiated a Phase 2 proof-of-concept clinical trial in the United States in 2021. Costs associated with conducting our clinical trial in 2021 were the primary reason for the increase in our R&D expenses in 2021. This increase was partially offset by $1.0 million in royalties from an upfront payment in 2020 in connection with the Mitsubishi license.

General and administrative expenses

General and administrative expenses increased $1.9 million for the year ended December 31, 2021 compared to the year ended December 31, 2020. The increase was primarily due to an increase in fees of $0.9 million related to accounting and legal support and compensation expenses of $0.8 million related to additional employees hired in early 2021 , and $0.2 million in other general expenses.

Other total expenses, net

Total other net expense increased $0.2 million for the year ended December 31, 2021 compared to the year ended December 31, 2020 and was related to our convertible debentures, which were converted into Series A Convertible Preferred Stock in February 2021. Specifically, during the year ended December 31, 2021, costs related to the change in fair value of the convertible bonds increased $0.3 million compared to the year ended December 31, 2020, partially offset by a decrease in interest expense of $0 $.1 million was offset for the brief period in 2021 that the convertible debentures were outstanding prior to their conversion in February 2021.

operating results

Comparison of the nine months ended September 30, 2021 and 2022

research and development costs

Research and development expenses increased $8.7 million for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 primarily due to a $6.8 million increase in preclinical and clinical costs -Dollars related to research and development of lorundrostat, including $1.4 million in clinical consumables, manufacturing and regulatory costs, and $0.5 million in personnel expenses for additional staff to support research and development.

We began a proof-of-concept phase 2 clinical trial in the United States in 2021. Costs related to conducting our clinical study were the main reason for the increase in our research and development expenses.

General and administrative expenses

General and administrative expenses increased $1.1 million for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The increase was primarily due to higher US compensation expenses of $0.6 million related to additional staff and fees of $0.4 million for accounting, legal and other support.

Total other income (expenses), net

Total other net income increased $1.4 million for the nine months ended September 30, 2022 compared to total other net expense for the nine months ended September 30, 2021 and was primarily due to a 0.7% increase in interest income $0.7 million related to interest income related to investments in money market funds and U.S. Treasuries for the nine months ended September 30, 2022 and $0.7 million to expenses for fair value changes on our convertible bonds for the nine months ended September 30, 2021. The convertible debentures were converted into Series One Convertible Preferred Stock in February 2021 and no change in fair value was recorded after that date.

liquidity and capital resources

We have experienced net losses and negative cash flows from operations since inception and expect to continue to incur net losses and negative cash flows from operations for the foreseeable future as we continue development, obtain regulatory approval and potentially commercialize lorundrostat, seek to identify, evaluate, acquire and license relevant intellectual property or develop additional product candidates and become a public company. From inception through September 30, 2022, we have received approximately $158 million in aggregate gross proceeds from the issuance of convertible debentures and convertible preferred stock. As of September 30, 2022, we had cash, cash equivalents and marketable securities of $121.0 million.

funding needs

Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities, together with the estimated net proceeds from this offering, will be sufficient to support our anticipated cash needs for at least the next 18 months. However, our prediction of the period during which our financial resources will be sufficient to support our business is a forward-looking statement that involves risks and uncertainties, and actual results could differ materially. We are basing this estimate on assumptions that may be incorrect and we may exhaust our capital resources sooner than expected. In addition, the process of testing product candidates in clinical trials is expensive, and the timing of progress and expenditure in these trials is uncertain.

Our future capital needs will depend on many factors including but not limited to:

•the initiation, nature, number, scope, progress, extensions, results, costs and timing of clinical and preclinical studies of lorundrostat and any future product candidates we may select, including any changes to clinical development plans based on feedback we may receive from regulatory authorities;

•our ability and strategic decision to develop future product candidates beyond lorundrostat and the timing of such development, if any;

•our ability to receive timely regulatory approvals for lorundrostat, any future product candidates and additional indications for lorundrostat and any future product candidates in the jurisdictions in which we or prospective partners are seeking such approvals;

•the cost and time to manufacture lorundrostat or any prospective product candidate, including commercial manufacturing on a sufficient scale if a product candidate is approved, including as a result of inflation, supply chain issues or component shortages;

•any additional jurisdictions in which we are seeking regulatory approval for lorundrostat and any future product candidates and the timing of filing for regulatory approval in those jurisdictions;

•the cost, timing and outcome of regulatory meetings and reviews of lorundrostat or future product candidates;

•delays and cost increases that may result from COVID-19 or any future pandemic;

•the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights;

•our efforts to improve operating systems and hire additional staff to meet our obligations as a public company, including improved internal controls over financial reporting;

•the costs associated with hiring additional staff and consultants as our business grows, including additional managerial and clinical, regulatory, CMC, quality and commercial development staff;

•the term and amount of any milestone payments, royalties or other payments we are required to make to Mitsubishi Tanabe, from which we license Lorundrostat, or to prospective licensors;

•the cost and time of establishing or securing sales and marketing capabilities if lorundrostat or a future product candidate is approved;

•our ability to achieve sufficient market acceptance, coverage and reimbursement from third-party payers, and market share and revenue for approved products;

•the willingness of patients to pay for approved products out-of-pocket in the absence of adequate coverage and/or reimbursement from third-party payers;

•the conditions for establishing and maintaining collaborations, licenses and other similar agreements;

•costs related to any products or technology we may license or acquire; And

•the other risks and uncertainties described under "Risk Factors", "Special Cautionary Note Regarding Forward-Looking Statements" and elsewhere in this Prospectus.

If we are able to generate significant product revenue to date, we expect to be able to meet our liquidity needs through equity offerings, debt financing or other sources of capital, including potential collaborations, licensing and other similar arrangements. We have no set external funding source. To the extent that we raise additional capital through the sale of stock or convertible debt securities, our shareholders' ownership interests may be diluted and the terms of those securities may involve liquidation or other preferences that adversely affect the rights of our common shareholders. Debt financing and equity financing, where available, may include arrangements that contain provisions that restrict or limit our ability to take certain actions, such as: B. taking on additional debt, investing or declaring dividends. Our ability to raise additional funds may be hampered by the potential for deteriorating global economic conditions and disruptions and volatility in financial and credit markets in the United States and around the world resulting from factors such as, but not limited to , inflation, conflicts between Russia and Russia arise Ukraine and other factors reducing liquidity and availability of credit decrease

Consumer confidence, slowing economic growth, rising unemployment rate and uncertainty about economic stability. If equity and credit markets deteriorate, it could make necessary debt or equity financing more difficult, expensive and dilutive. If we raise additional funds through future collaborations, licenses, or other similar arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, product candidates, intellectual property from research programs, or proprietary technology, or grant licenses on terms that may be unfavorable to us and/or may decrease the value of our common stock. If we are unable to raise additional funds through equity or debt financing or other arrangements when needed or on terms acceptable to us, we may have to delay, limit, reduce or terminate our future product development or commercialization efforts, or grant development rights and our Commercialize product candidates, even if we prefer to develop and commercialize such product candidates ourselves or on less favorable terms than we would choose.

Cashflows

Comparison of the fiscal years ended December 31, 2020 and 2021

Since inception, we have used our cash primarily to fund expenses related to the licensing and development of lorundrostat. The following table provides a summary of cash flows for the periods presented:

operational activities

Net cash used in operations for the year ended December 31, 2021 increased to $14.6 million compared to $2.5 million for the year ended December 31, 2020 primarily due to an increase in Cash used to support our operations, including but not limited to the cost of developing lorundrostat and related clinical trials, personnel and compensation costs, and general working capital requirements. The $12.1 million increase in cash employed was also due to a $16.0 million increase in net loss, partially offset by the net effect of changes in working capital of $3.6 million and an increase offsetting $0.3 million of non-cash operating expenses.

Financial Activities

Net cash provided by financing activities of $23.8 million for the year ended December 31, 2021 increased $20.0 million from $3.8 million for the year ended December 31, 2020. In 2021 we have $23.8 million in net proceeds from the issuance and sale of our Series A Convertible Preferred Stock. In 2020, we had net proceeds of approximately $3.9 million from the sale of convertible debentures.

Comparison of the nine months ended September 30, 2021 and 2022

The following table provides a summary of cash flows for the periods presented:

operational activities

Net cash used in operations for the nine months ended September 30, 2022 increased to $19.0 million compared to $9.7 million for the nine months ended September 30, 2021 primarily due to an increase in was due to cash used to support our operations. including but not limited to the development of lorundrostat and related clinical trial expenses, personnel and compensation expenses, attorney and consulting fees in support of our operations and general capital requirements. The $9.4 million increase in cash employed was due to an $8.4 million increase in net loss, a $0.8 million decrease in noncash operating expenses and the net effect of changes in stock turnover $0.2 million attributed.

investment activities

Net cash used in investing activities of $71.8 million for the nine months ended September 30, 2022 increased from zero for the nine months ended September 30, 2021 reflecting our investments in money market funds and US Government Bonds during the nine months ended September 30, 2022 upon receipt of cash proceeds from the issuance of Series A and B convertible preferred stock in 2022.

Financial Activities

Net cash provided by financing activities of $129.1 million for the nine months ended September 30, 2022 increased compared to $23.8 million for the nine months ended September 30, 2021. For the months ended September 2022, we received an aggregate of $129.6 million in net proceeds from the issuance of our Series A and B convertible preferred stock and made payments of $0.6 million for honoraria and other costs associated with this offering. For the nine months ended September 30, 2021, we received $23.8 million in net proceeds from the issuance and sale of our Series A convertible preferred stock.

Contractual Obligations and Commitments

Under the Mitsubishi License, we have milestone payment obligations that are contingent on the achievement of certain development milestones and certain product sales, and we are obligated to pay certain royalties in connection with sales of products developed under the agreement. We are currently unable to estimate the timing or likelihood of achieving any milestones or future product sales. See above and Note 4. “Commitments and Contingencies” to our Financial Statements included elsewhere in this Prospectus for additional information on the Mitsubishi License. For more information on Mitsubishi License, see Business - Intellectual Property - License Agreement with Mitsubishi Tanabe.

We contract for contract research, contract manufacturing, professional services and other services and products in the ordinary course of business. These contracts usually provide for termination after a period of notice and are therefore cancellable contracts.

Critical Accounting Policies and Significant Judgments and Estimates

We have prepared the financial statements in accordance with generally accepted accounting principles in the United States of America. The preparation of these financial statements requires that we make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the financial statements and the reported amounts of expenses during the period. Management continually evaluates its critical estimates, including those related to research and development expenses. We base our estimates on our historical experience and assumptions that we believe to be reasonable; however, actual results could differ materially from these estimates under different assumptions or conditions.

See Note 2 for information on our significant accounting policies.”Summary of Significant Accounting Policies' of the notes to our financial statements in this prospectus.

Prepaid and Accrued Research and Development Costs

In the process of preparing our financial statements, we are required to estimate our prepaid and accrued research and development costs. This process includes reviewing open contracts and purchase orders, communicating with our employees to identify services performed on our behalf and estimating the level of service provided and the associated costs incurred for the service, if we are still no invoice was issued or otherwise informed of the actual cost. Most of our service providers provide us with overdue monthly invoices for services rendered. We estimate our prepaid and accrued research and development costs at each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We confirm the accuracy of the estimates with service providers and make adjustments where necessary. Examples of prepaid and accrued estimated research and development expenses include expenses for:

•CROs associated with clinical trials;

•research sites related to clinical trials;

•providers in connection with pre-clinical development activities; And

•Suppliers related to product manufacturing, development and distribution of clinical materials.

Prepaid and accrued expenses related to clinical trials are based on our estimates of services received and effort expended under contracts with various research organizations and CROs that conduct and manage clinical trials on our behalf. The financial terms of these agreements vary from contract to contract and can result in uneven cash flows. Payments for some of these contracts are dependent on factors such as patient enrollment and the completion of clinical trial milestones. When accumulating costs, we estimate the period over which the services will be provided and the effort that must be expended in each period based on patient registration, clinical site activation or information provided to us by our providers about the actual costs incurred. Any estimates as to the extent of services provided or the cost of those services may differ from actual results.

To date, we have not identified any material changes in our estimates of cumulative research and development expenses after a reporting period. However, due to the nature of the estimates, we cannot guarantee that we will not change our estimates in the future if we become aware of additional information regarding the status or conduct of our clinical trials and other research activities.

Fair value option for convertible bonds

We have elected to account for our convertible bonds at fair value in order to measure these liabilities at amounts that more accurately reflect the current economic environment in which the Company operates. We recognize the convertible debentures at fair value on the date of each issuance, with changes in fair value recognized in profit or loss each reporting period until they are converted into Series A Convertible Preferred Stock in February 2021. The fair value of the convertible bonds was determined using a valuation model based on the transaction method. The key assumptions used to determine the fair value of the put option include the estimated probability of the put option being exercised and the discount rate used to calculate the fair value. The estimated probability of exercise is

based on management's expectation for future equity financing transactions. The discount rate is based on the weighted average effective yield on bonds previously issued by the Company adjusted for changes in market yields on CCC rated biotech bonds.

Determining the fair value of our common stock

Because there was no public market for our common stock, we have historically had to estimate the fair value of the common stock underlying our stock awards when performing fair value calculations for all periods prior to this offering. The fair value of the common stock underlying our share awards was determined at each grant date by our Board of Directors using management information and independent third party valuation analysis. All options to purchase our common stock must be granted at a per-share exercise price no less than the per-share fair value of our common stock underlying those options at the grant date, based on information known to us at the grant date . Prior to receiving the license from Mitsubishi in July 2020, the fair value of our common stock was nominal as we were insufficiently capitalized and had no assets that could be used to generate future revenue. After receiving a license from Mitsubishi, we consider a number of objective and subjective factors to determine the fair value of our common stock, including:

•valuations of our common stock conducted with the assistance of independent independent valuation professionals;

•our stage of development and business strategy, including the status of lorundrostat research and development efforts and material risks related to our business and industry;

•our results of operations and financial condition, including our available capital resources;

•the evaluation of public companies in the life sciences and biotechnology sectors and recent mergers and acquisitions of similar companies;

•failure to market our common stock as a private company;

•the prices of our convertible preferred stock sold to investors in separate transactions and the rights, preferences and privileges of our convertible preferred stock over those of our common stock; And

•the likelihood of a liquidity event affecting holders of our common stock, such as an IPO or sale of our business, taking into account prevailing market conditions.

Significant judgment and estimates are involved in determining the fair value of our common stock. These judgments and estimates include making assumptions about our future operating performance, the time to completion of an IPO or other liquidity event and determining appropriate valuation techniques. If we had made different assumptions, our net loss and net loss per common share could have been significantly different.

Upon completion of this offering, the fair value of our common stock will be based on the reported closing price on the grant date on the principal stock exchange on which our common stock is traded.

Share-based Compensation Expense

Stock-based compensation expense represents the fair value cost of the stock awards at grant date, which is recognized over the required service period of the awards (generally the vesting period) on a straight-line basis, with forfeiture recognized when they occur. We have not recognized any material amount of stock-based compensation and we have no material amount of unrecognized stock-based compensation related to these awards.

We estimate the fair value of option grants using the Black-Scholes option pricing model. Estimating the grant date fair value of stock awards using valuation models such as the Black-Scholes option pricing model is influenced by assumptions about a number of variables, including the risk-free rate and expectancy

stock price volatility, the expected life of the stock options, the expected dividend yield and the fair value of the underlying common stock at the grant date. Changes in assumptions could materially affect fair value and ultimately how much stock-based payment expense is recognized. These entries are subjective and often require significant analysis and judgment to develop. See note 2.”Summary of Significant Accounting Policies” of the notes to our financial statements in this prospectus for information about some of the specific assumptions we use in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in 2021 and 2022.

The intrinsic value of all options outstanding as of September 30, 2022 was $18.6 million based on an assumed IPO price of $15.00 per share (the midpoint of the specified price range on the cover of this prospectus), of which approximately 3 $.1 million related to vested options and approximately $15.5 million related to unvested options.

In December 2022, we granted options to purchase an aggregate of approximately 44,510 common shares at an exercise price of $3.03 per share, generally vesting over a four-year mandatory service period. The exercise prices of the stock options we granted in December 2022 were equal to the fair value of one share of our common stock at the grant date, as determined by our Board of Directors at the grant date. Given the progress in completing an IPO and the information we received in estimating our IPO price range, we have determined the fair value of the December concessions for financial reporting purposes based on a linear interpolation from the November 2022 valuation to the midpoint of the initial price range for this offering to determine the appropriate stock-based compensation expense. Therefore, while we have not yet prepared financial statements for the fourth quarter and full year 2022, for financial reporting purposes only, we anticipate stock-based compensation expense for December 2022 awards of approximately $0.5 million, or 0.1 US$ millions per year on an annualized basis over the required four years of service. The amount of the stock-based compensation expense related to these options is based on our estimates and is subject to change as events and circumstances change.

JOBS Act and Minor Reporting Company Status

As an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the JOBS Act), we may use an extended grace period to comply with new or revised accounting standards. This allows an emerging and growing company to defer the adoption of certain accounting standards until those standards apply to private companies. We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and as a result of this decision our financial statements may not be comparable to those of companies that comply with the reporting dates of publicly traded companies. We intend to rely on other exceptions provided by the JOBS Act, including but not limited to failure to meet the certification requirements for public accountants under Section 404(b) of Sarbanes-Oxley.

We will remain an emerging growth company through (i) the last day of the fiscal year following the fifth anniversary of the consummation of this Offering, (ii) the last day of the fiscal year in which we have aggregate annual gross sales of at least $1.235 billion, (iii) the last Date of the financial year in which we are considered a "large accelerated filer" within the meaning of Rule 12b-2 of the Securities Exchange Act, which would occur if, among other things, the market value of our common stock held by unaffiliated companies increased on the last business day of exceed $700.0 million in the second fiscal quarter of this year (subject to certain conditions), or (iv) the date we issue more than $1.0 billion in non-convertible debt securities in the previous three-year period.

We are also a minor reporting entity for the purposes of the Securities Markets Act. We can continue to be a smaller reporting company even though we are no longer an emerging growth company. We may use some of the sizing available to smaller reporting companies, and we may use those sizing as long as our unaffiliated voting and non-voting common stock is less than $250.0 million as of the last business day of our second fiscal quarter or our annual income is less than $100.0 million during the most recently ended fiscal year and our voting and non-voting common stock held by unaffiliated companies is less than $700.0 million as of the last business day of our second fiscal quarter.

Current accounting pronouncements

We have reviewed all recently issued accounting pronouncements and have concluded that, except as noted elsewhere in this prospectus, these standards do not have a material impact on our financial statements or are otherwise applicable to our business.

Quantitative and qualitative information on market risk

They are dangerous

We are exposed to market risk relating to changes in interest rates on our investment portfolio of cash and marketable securities. As of September 30, 2022, our cash equivalents and marketable securities consisted of money market funds and US Treasury bills. As of December 31, 2020 and 2021, we had no cash equivalents or marketable securities. Our primary market risk is sensitivity to interest income, which is affected by changes in the general level of US interest rates. The fair value of our short-term cash equivalents and marketable securities is subject to change due to potential changes in market interest rates, including changes due to the impact of the COVID-19 pandemic. Because of the nature of our cash equivalents and marketable securities, we believe that a hypothetical instantaneous 10% change in interest rates would not have a material impact on our results of operations for the periods presented.

Risk Cambiales

We are exposed to market risks related to changes in exchange rates. We contract with suppliers located outside the United States and some invoices are denominated in foreign currencies. In connection with these agreements, we are subject to exchange rate fluctuations. To date, these fluctuations have not been significant and we have no formal currency hedging program. We believe that a hypothetical immediate 10% change in foreign exchange rates over the periods presented would not have a material impact on our results of operations.

Impact of Inflation

Inflation generally affects us by increasing our labor costs and the cost of research and development contracts. Although we do not believe that inflation has had a material impact on our financial condition or results of operations at this time, in the foreseeable future (particularly if inflation rates continue to rise) we could have some impact due to an impact on the cost of conducting clinical trials, labor costs to recruit and retention of qualified personnel and other operating costs. Inflationary costs could adversely affect our business, financial position and results of operations.

PURSUE

Business Overview

We are a clinical-stage biopharmaceutical company focused on developing drugs to treat diseases caused by abnormally elevated aldosterone. Our product candidate, lorundrostat, is a highly selective, orally administered aldosterone synthase inhibitor (ASI) that we are initially developing for the treatment of patients with uncontrolled hypertension (uHTN), defined as individuals who cannot achieve blood pressure below 130/80 mmHg despite taking two or more antihypertensive drugs or resistant hypertension (rHTN), defined as individuals who cannot achieve blood pressure below 130/80 mmHg despite taking three or more antihypertensive drugs, typically including a diuretic. There are more than 115 million patients with hypertension (BP) or hypertension in the United States, and more than half of this population is unable to meet their blood pressure goals, defined as blood pressure of 130/80 mmHg, with currently available medications . There are more than 30 million treated patients who do not reach their blood pressure goal, of whom approximately 20 million have systolic blood pressure readings above 140 mmHg. Patients with high blood pressure that persists despite taking two or more medications are 1.8 and 2.5 times more likely to die from cardiovascular disease and stroke, respectively. In a phase 2 clinical study in 200 subjects with uHTN and rHTN (Target-HTN), lorundrostat demonstrated clinically and statistically significant reductions in blood pressure with once-daily dosing and was well tolerated. In addition to hypertension, we intend to develop lorundrostat for the treatment of chronic kidney disease (CKD) and believe that our product candidate promises to be an innovative solution to the growing unmet need in various cardiovascular diseases.

Hypertension is one of the most common diseases worldwide, affecting approximately 1.3 billion people and resulting in an estimated average annual economic burden of US$130 billion between 2003 and 2014 in the United States alone. Despite the availability of various treatment options, including thiazide diuretics, B. angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, beta blockers, and mineralocorticoid receptor antagonists (MRAs), the prevalence of uHTN continues to increase increasing, which is being exacerbated by rapidly increasing obesity. More than 30 million hypertensive patients in the United States are unable to reach their blood pressure goal despite treatment. Within this population there are approximately 10.3 million patients suffering from rHTN. Several large studies have shown that patients who do not reach their blood pressure goal have a significantly increased risk of developing heart disease, stroke and kidney disease (Wright JT Jr., et al. A randomized trial of intensive versus standard blood pressure control N Engl J Med.2015;373(22):2103-2116;and Zhou, et al., Uncontrolled hypertension increases risk of all-cause mortality and cardiovascular disease in US adults: the NHANES-linked mortality study III Scientific Reports, 2018;8 (1):1-7). Patients with rHTN have a 1.5 and 2.3 times greater risk of composite cardiovascular events and end-stage renal disease, respectively, than normotensive patients. Despite this significant and growing unmet need, there has been a paucity of new therapies for high blood pressure approved by the US Food and Drug Administration (FDA), and no new class of antihypertensive treatments have been approved in the past fifteen years.

Abnormally elevated aldosterone levels are a key factor in hypertension in approximately 25% of hypertensive patients. Given the close homology between the enzymes that regulate aldosterone and cortisol synthesis, as well as the role of aldosterone in potassium regulation, the development of an effective hypertensive therapy that targets aldosterone synthase remains a major challenge. Several large pharmaceutical companies have attempted to develop ASIs, but their efforts have been hampered by insufficient selectivity for aldosterone, leading to off-target toxicities associated with cortisol inhibition. These challenges have led to the discontinuation of many ASIs that are in development to date.

Our product candidate lorundrostat

Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective ASI designed to lower aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. We licensed lorundrostat from Mitsubishi Tanabe Pharmaceutical Company (Mitsubishi Tanabe), who discovered the compound and did the initial pioneering work, including demonstrating the selectivity of lorundrostat and advancing the compound through Phase 1 clinical development. We closed the target HTN -Study ab, a phase 2 proof-of-concept study for lorundrostat in the treatment of uHTN and rHTN in 2022. Given that hypertension and abnormalities

Because aldosterone can lead to cardiovascular disease, we intend to further develop lorundrostat in other indications such as the treatment of chronic kidney disease.

*The first human phase 1 clinical trial of lorundrostat was conducted by Mitsubishi Tanabe. See “Results of the phase 1 clinical study” starting on page 109 for further details on this study.

We can rely on data from the completed Phase 1 study of lorundrostat in healthy volunteers and intend to use observations from this study and the Phase 2 study of uHTN and rHTN to guide the development of lorundrostat for the treatment of CKD to inform.

Target-HTN was a randomized, double-blind, placebo-controlled study conducted in the United States in 200 subjects on uHTN and rHTN to evaluate the efficacy of lorundrostat at various doses once or twice daily. All subjects had to remain on background medication.

Key Clinical Outcomes of Target-HTN

*Repeated measures mixed effects (MMRM) model results for 100 mg QD Part 1 and 50 mg QD were -7.8 mmHg and -9.6 mmHg, respectively. Observed means include only those with observations at visit eight without imputation of missing values, while MMRM imputes missing values. Observed mean and MMRM values ​​may vary slightly.

**Results of post-hoc sensitivity analysis reflecting subjects who passed quality control criteria and had baseline AOBP and ABPM > 130 mmHg.

The results of the Target HTN study demonstrated a clinically significant and placebo-adjusted statistically significant reduction in systolic blood pressure as measured by automated office blood pressure (AOBP) of 9.6 mmHg (p<0.01) and 7.8 mmHg (p< 0.04) in the 50 mg and 100 mg once daily (QD) cohorts, respectively. A p-value is the probability that the reported outcome occurred purely by chance, i.e. a p-value less than or equal to 0.05

means that the difference between the control group and the treatment group is purely coincidental with a probability of less than or equal to 5%. A p-value of 0.05 or less typically represents a statistically significant result. The FDA's standard of proof when evaluating clinical trial results is generally based on a p-value less than or equal to 0.05. A meta-analysis of 147 randomized trials showed that a 10 mmHg reduction in systolic blood pressure or a 5 mmHg reduction in diastolic blood pressure reduced the risk of stroke by 41% and the risk of coronary artery disease by 22%. The reduction in systolic blood pressure as measured by AOBP was validated and corroborated by comparable reductions in systolic blood pressure with lorundrostat as measured by 24-hour mean ambulatory blood pressure (ABPM). ABPM data also demonstrated the benefits of lorundrostat in reducing central and nocturnal blood pressure, which have been strongly associated with cardiovascular health risks. The study results also highlighted that patients with a body mass index (BMI) greater than 30 or obese patients at high risk for cardiovascular disease experienced a placebo-adjusted reduction in systolic blood pressure of 12.3 or 16.7 mmHg a 100 mg QD dose and a 50 mg QD dose, respectively. Treatment-emergent serious adverse events (SAEs) were reported in three subjects, one of which was considered possibly related to lorundrostat in a subject with pre-existing, worsening hyponatraemia that resolved upon discontinuation. The two active once-daily doses resulted in a slight increase in potassium levels in the cohorts of 0.25 mmol/L at the 50 mg daily dose and 0.29 mmol/L at the 100 mg daily dose. Six subjects experienced transient elevations of serum potassium greater than 6.0 mmol/L, none of which were considered SAEs, and all resolved rapidly after discontinuation or dose adjustment, consistent with the short half-life of lorundrostat. One of the events was evaluated as incorrect due to incorrect processing of the sample. As predicted and similar to ACE inhibitors and ARBs, the antihypertensive effect of lorundrostat resulted in a beneficial and reversible dose-dependent reduction in estimated glomerular filtration rate (eGFR), a measure of kidney function. Finally, the selectivity of lorundrostat for the inhibition of aldosterone was confirmed, since cortisol levels were not inhibited over the entire dose range.

In November 2022, we held an end-of-phase 2 meeting with the FDA to (i) review the results of the Target-HTN study and (ii) discuss our plans for a foundational hypertension treatment program. Based on the Phase 2 results and FDA feedback, we plan to initiate the lorundrostat flagship program below starting in 2023.

We plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in the first half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to baseline treatment of two or three antihypertensive drugs in up to about 240 adults. Patients will be randomized into three cohorts and treated for 12 weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and then titrated to 100 mg QD at week four or placebo. The primary endpoint of the study will be change in systolic blood pressure compared to placebo. Key data from this study is expected in the first half of 2024. We also plan to initiate a phase 3, randomized, double-blind, placebo-controlled study in the second half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to background treatment with two or more antihypertensive drugs in up to about 1,000 adults. The study is expected to be similar in design to the planned Phase 2 study described above. Primary data from this study are expected in mid-2025. We also plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN a CKD Population with pivotal data from this study is expected in the first half of 2024. The pivotal program will include an open-label extension study open to all participants in the above studies.

Our strategy

Our strategy is to develop and commercialize lorundrostat for the treatment of diseases caused by abnormally elevated aldosterone, initially focusing on hypertension with the aim of eventually expanding to other cardiovascular diseases. Key elements of our strategy include:

•Advancement of lorundrostat, our ASI product candidate, through clinical development for the treatment of uHTN and rHTN.uHTN and rHTN represent a significant unmet need among the 115 million patients in the United States who suffer from hypertension. More than half of hypertensive patients fail to reach their blood pressure goals despite treatment, and approximately 20 million treated patients have systolic blood pressure greater than 140 mmHg. Data from our Phase 2 Target-HTN study showed that lorundrostat reduced systolic blood pressure in patients with uHTN and rHTN by clinically and statistically significant levels, with a placebo-adjusted mean reduction in systolic blood pressure of 9.6 or 7.8 mmHg at 50 or 100mg

QD dose. In addition, treatment with lorundrostat has demonstrated a robust effect in obese patients, who studies have shown to be prone to abnormal aldosterone biology. We believe our approach to normalizing aldosterone levels may provide an effective and more targeted approach to treating hypertension. We plan to further advance the development of lorundrostat in hypertension and expect to initiate two clinical trials evaluating the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN in 2023, as well as an open-label extension study.

•Expanding development of lorundrostat into additional indications where abnormally elevated aldosterone is a critical factor in disease pathology, including CKD and potentially other cardio-renal indications.Lorundrostat was designed to normalize aldosterone production and we believe this mechanism could be applied to other indications where abnormal aldosterone biology plays a role. We plan to begin a Phase 2 uHTN and rHTN trial in a CKD population in mid-2023. Uninhibited aldosterone is known to play a critical role in the progression of CKD, which affects more than 23 million people in the United States. In addition, we can expand the development of lorundrostat to other cardio-renal indications.

•Evaluate strategic partnerships opportunistically to maximize the value of lorundrostat.We have worldwide rights to develop and commercialize lorundrostat. Given the potential of aldosterone inhibition to treat various cardio-renal diseases, we may explore partnerships with other biopharmaceutical companies that can provide expertise and resources to expand the development and commercialization of lorundrostat.

•Continue to explore opportunities to selectively expand our pipeline beyond lorundrostat.Our team has experience in various aspects of drug discovery, clinical development, business development and commercialization. We will continue to leverage our team's expertise to selectively evaluate potential strategic partnerships, collaborations, in-licensing and acquisitions to expand our pipeline, particularly in cardio-renal indications.

history of hypertension

In healthy individuals, normal blood pressure, also known as peripheral blood pressure, is less than 130 over 80, meaning the pressure measured is less than 130 mmHg when the heart is contracting (systolic blood pressure) and equal to or less than 80 mmHg when when the heart is relaxed (diastolic blood pressure). High or persistent high blood pressure or hypertension can lead to an increased risk of life-threatening complications such as heart disease, stroke or kidney disease, among other things.

The prevalence of hypertension has increased in recent decades. A comprehensive study published in The Lancetjournal shows that the total number of cases of high blood pressure in patients aged 30 to 79 almost doubled worldwide from 1990 to 2019. In addition, obesity, particularly associated with increased visceral obesity, is a major cause of hypertension, accounting for 65% to 75% of the risk of developing primary (essential) hypertension in humans. Although hypertension is one of the most common preventable risk factors for premature death, approximately 1.3 billion people worldwide have hypertension, with hypertension being a leading cause of or contributing to more than 670,000 deaths in the United States alone in 2020. The costs of high blood pressure and health problems are a major burden on already overburdened healthcare systems, with an estimated average annual economic burden of $130 billion in the United States alone between 2003 and 2014. available, most of which are generic and affordable, more than half of all hypertensive patients treated do not reach their blood pressure goal.

The current standard of care for patients with newly diagnosed hypertension is based on a set of guidelines established by the American College of Cardiology and the American Heart Association. The target BP of a hypertensive patient is defined as below 130/80 mmHg. Depending on baseline blood pressure levels, these guidelines recommend that the patient typically begin with lifestyle changes and then, if blood pressure does not reach the desired target level, begin treatment with antihypertensive agents selected primarily from the following five classes of drugs, which can later be combined with each other if the patient's target blood pressure is not successfully achieved with the initial therapy:

•thiazide diuretics, which increase fluid excretion by the kidneys by blocking the reabsorption of sodium and chloride in the nephron;

•ACE inhibitors, which inhibit the renin-angiotensin-aldosterone system axis and block the action of ACE in the lungs, which converts angiotensin I to angiotensin II;

•ARBs that block the action of angiotensin II at the level of angiotensin receptors;

•calcium channel blockers, which slow heart contractions and relax arteries and prevent calcium from entering heart cells and arteries; And

•Beta-blockers, which make the heart beat slower and less vigorously, which lowers blood pressure.

Despite the many treatment options available, most hypertensive patients require multiple therapies to reach their goal blood pressure. There is evidence that the addition of a second or third line antihypertensive drug generally results in an additional 6 to 7 mmHg reduction in systolic blood pressure. However, the incremental reduction in systolic blood pressure achieved through successive lines of treatment does not always allow patients to adequately meet their blood pressure goal. As a result, many patients require three, four, or more antihypertensive drugs to reach goal blood pressure. Additionally, although hypertension is an asymptomatic condition, many of the currently available treatments have side effects and tolerability issues that may limit their use. For example, patients taking ACE inhibitors often develop a chronic cough, and those taking beta-blockers often experience lethargy.

A meta-analysis of 147 randomized trials showed that a 10 mmHg reduction in systolic blood pressure or a 5 mmHg reduction in diastolic blood pressure reduced the risk of stroke by 41% and the risk of coronary artery disease by 22%. The Systolic BP Intervention Trial (SPRINT) further showed that in adults with hypertension but without diabetes, lowering systolic blood pressure below 120 mmHg reduced cardiovascular events by 25% and the risk of all-cause death by 27% compared to those with systolic blood pressure of 140 mmHg or higher. The importance of nocturnal blood pressure as a predictor of cardiovascular risk is increasingly recognized. There is evidence that higher nocturnal systolic blood pressure is strongly associated with increased cardiovascular risk. The study results emphasize the importance of targeting a reduction in nocturnal systolic blood pressure when considering treatment approaches.

More than 30 million hypertensive patients in the United States are unable to reach their blood pressure goal despite treatment, and within this population 10.3 million have rHTN. Treatment options for patients with rHTN are limited, and the current standard of care is to add an MRA agent that blocks the action of aldosterone to their existing antihypertensive regimen.

Background of aldosterone and its role in hypertension

Aldosterone is a mineralocorticoid steroid hormone produced primarily in the outer layer of the adrenal gland, the adrenal cortex, which plays an important role in controlling water and salt balance, maintaining sodium, and releasing potassium from the body. This maintenance of homeostasis ensures that the body can maintain normal blood pressure.

In a healthy person, homeostatic balance is maintained by a feedback loop called the renin-angiotensin-aldosterone system (RAAS). Renin is a key enzyme released by the kidneys when they sense changes in blood pressure to control aldosterone production and help the kidneys regulate water and salt levels in the body. In a normal physiological state, aldosterone production increases when blood pressure is very low and decreases when blood pressure is very high. Because of the link between renin levels and aldosterone production, this is considered renin-dependent hypertension.

Besides the self-regulated RAAS, there are other pathways that drive aldosterone production. New information on the hormonal regulation of visceral adipocytes and the adrenal gland supports the hypothesis that adipokines, particularly elevated leptin and reduced adiponectin, can affect aldosterone and renin, respectively. The end result is an increase in aldosterone and prevention of renin's normal feedback inhibition. This is considered renin-independent aldosterone production and is due to the dysregulated systems biology often prevalent in an obese population.

Overview of renin-dependent and renin-independent aldosterone production

Elevated aldosterone also causes insulin resistance, inflammation and fibrosis of the heart, fibrosis and remodeling of blood vessels, and tubulointerstitial fibrosis and glomerular damage in the kidney. Excess aldosterone is believed to lead to an increased risk of stroke, kidney damage, congestive heart failure, and heart attack compared to high blood pressure alone. Many of these symptoms are often comorbidities in an obese population.

Many of the therapies used to treat hypertension, such as ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics, were developed and introduced several decades ago, when the incidence of obesity was less than 20% and abnormal aldosterone production was less than 10% affected. the US population. The increasing prevalence of obesity and hypertension, driven by the renin-independent axis, has resulted in a higher incidence of uHTN and rHTN. Currently available therapies are generally effective in treating renin-dependent hypertension; However, they do not adequately address the changing biology of hypertension today. For example, ACE inhibitors and ARAs indirectly lower aldosterone levels, but up to 40% of treated patients experience an 'aldosterone breakthrough', in which their aldosterone levels return to normal or higher, leading to elevated blood pressure.

Increasing obesity epidemic correlates with increased hyperaldosteronism

MRAs, first introduced in the 1950s, are thought to work by blocking the renin-independent or renin-dependent action of aldosterone on the mineralocorticoid receptor (MR), but not by inhibiting aldosterone production. There are two well-known MRAs available in the United States to treat high blood pressure, spironolactone and eplerenone, both of which are available generically. ARMs are known to be effective in lowering blood pressure; However, they have shown side effects that have limited their use. In particular, spironolactone, the most commonly prescribed MRA, is known to induce hyperkalemia as well as gynecomastia in men and fertility problems in women. In addition, when aldosterone binding to MR is blocked, circulating aldosterone levels increase two to threefold and can cause other adverse effects in the body unrelated to MR.

More recently, several pharmaceutical companies have attempted to develop ASIs. The approach of blocking aldosterone synthesis and reducing plasma aldosterone levels is considered a preferable approach to using MRAs, which block the effects of aldosterone on MRI. However, the task of creating a secure and effective ASI has proven to be technically challenging. The key enzymes in the synthesis of aldosterone and cortisol share a high degree of amino acid sequence similarity. Therefore, an ASI must be very selective in inhibiting aldosterone synthesis without affecting cortisol synthesis. Initial attempts to develop ASIs failed in preclinical or clinical development due to their inability to selectively inhibit aldosterone, resulting in such ASIs inhibiting cortisol levels and associated adverse effects.

Our product candidate lorundrostat

Our product candidate, lorundrostat, is a highly selective, orally administered ASI that aims to lower aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. We are initially developing lorundrostat for the treatment of hypertension and recently completed Target-HTN, our first Phase 2 proof-of-concept clinical trial. In this study, lorundrostat was well tolerated and demonstrated compelling clinical results and unparalleled dosing flexibility. Day. The observed half-life of 10 to 12 hours of lorundrostat has the potential to normalize aldosterone levels to achieve clinically meaningful reductions in blood pressure and flexibly manage the challenges of elevated serum potassium. Some of the key differentiators we have seen so far for lorundrostat compared to the originally developed ASIs are:

•Attractive clinical results:Target-HTN demonstrated a statistically significant reduction in systolic blood pressure of 9.6 mmHg and 7.8 mmHg in the 50 mg and 100 mg QD cohorts, respectively, which we believe is clinically significant. The reduction in systolic blood pressure was validated and confirmed by 24-hour mean ABPM, further demonstrating that lorundrostat causes central and nocturnal blood pressure reduction;

•High selectivity:Phase 1 and phase 2 clinical data showed high selectivity for aldosterone without cortisol suppression, as expected based on the 374 to 1 inhibitory effect on the CYP11B2 enzyme compared to the CYP11B1 enzyme responsible for cortisol synthesis;

•Ideal half-life:Most participants in our clinical study maintained serum potassium within the normal range. There have been minor cases of hyperkalemia requiring dose adjustment or discontinuation. Six subjects experienced transient elevations of serum potassium greater than 6.0 mmol/L, none of which were considered SAEs and all resolved rapidly upon discontinuation or dose adjustment. One of the events was evaluated as incorrect due to incorrect processing of the sample. the observed half-life of 10 to 12 hours for lorundrostat may be considered by physicians to be more favorable compared to compounds with longer half-lives, which may have a greater risk of sustained potassium elevation; And

•Convenient and well-tolerated dosage:Target-HTN has shown clinically significant results when dosed once daily. In addition, lorundrostat was well tolerated.

We plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in the first half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to baseline treatment of two or three antihypertensive drugs in up to about 240 adults. Patients will be randomized into three cohorts and treated for 12 weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and then titrated to 100 mg QD at week four or placebo. The primary endpoint of the study will be change in systolic blood pressure compared to placebo. Key data from this test are expected in the first half of 2024. We plan that too

Initiate a phase 3, randomized, double-blind, placebo-controlled study in the second half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to the background treatment of two or more antihypertensive drugs at up to to about 1000 adults. The study is expected to be similar in design to the planned Phase 2 study described above. Primary data from this study are expected in mid-2025. We also plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN a CKD Population with core data from this study expected in the first half of 2024. The core program will include an open-label extension open to all participants in the above studies.

Phase 2 clinical trial with target HTN

Target-HTN was a Phase 2, multi-center, randomized, double-blind, placebo-controlled, two-part study to evaluate the safety, efficacy, and tolerability of oral lorundrostat for the treatment of uHTN and rHTN when used as an add-on therapy to a stable background regimen of two or more Antihypertensive drugs in 200 men and women. The trial took place in the United States.

The objectives of the Target-HTN study were as follows:

•Proof of concept for the use of lorundrostat in patients with uHTN and rHTN;

•Establish a dosing range and treatment regimen for late-stage development;

•Determine if clinical results support a once-daily dosing regimen;

•Assess hypothetical predictors of clinical response, particularly obesity and plasma renin activity, as potentially useful strategies to prioritize the use of lorundrostat as a targeted therapy for hypertension;

•characterization of safety and preparation of an initial assessment of the risk-benefit profile; And

•Evaluation of exploratory results that may predict the future utility of lorundrostat in associated cardio-renal indications such as congestive heart failure and CKD.

The process was held in two parts. In Part 1, subjects were initially preselected for up to two weeks with the requirement that their systolic/diastolic blood pressure should be greater than 130/80 mmHg using two or more underlying medications indicated for hypertension such as ACE inhibitors, ARAs, calcium channel blockers, or diuretics. Study participants in Part 1 were also required to have low-grade renin hypertension, defined as hypertension with a plasma renin activity level of 1.0 ng/mL/h or less. Subjects were excluded if they were taking a sodium channel blocker or MRA. After subjects met prescreening criteria, they were followed for two weeks during a placebo-blind period during which their elevated blood pressure was reconfirmed as compatible with background medication and placebo. If patients were on baseline medication and maintained blood pressure greater than 130/80 mmHg, patients were randomized into five active cohorts and one placebo cohort. Subjects received one dose for eight weeks and were followed for an additional four weeks after study drug discontinuation.

Baseline demographics of patients enrolled in Target-HTN Part 1 - Complete Analysis Set (FAS).

We performed a preplanned interim analysis for Part 1 of the study when approximately one-third (65 subjects) of the planned enrollment completed at least 4 weeks of treatment, corresponding to approximately 10-12 subjects per cohort. To preserve the blinded nature of the study, the interim analysis was performed by a small team not involved in the operational aspects of the study, and no analysis results were shared with the operational staff at the clinical study sites. The primary objective of the interim analysis was to assess whether the chosen dose range appears to adequately span the subtherapeutic to maximal therapeutic response range as determined by the change in systolic blood pressure at week four compared to baseline. As a result of the interim review, we discontinued enrollment in two of the lower dose cohorts (12.5 mg QD and 12.5 mg BID) due to modest efficacy and the projected benefit-risk ratio and started Part 2 of the study.

Part 2 was designed to examine the effect of lorundrostat in patients with normal to high renin levels and we chose 100 mg QD as the dose to study based on its efficacy and safety as demonstrated in the interim analysis. Subjects enrolled in Part 2 were randomized to receive lorundrostat 100 mg once daily (n=31) or placebo (n=6) to maintain blinded study randomization. Part 2 subjects followed the same study approach as Part 1 subjects, except for the follow-up period, which was reduced from four weeks to two weeks.

The primary endpoint of Target-HTN was the change in pre-dose morning sitting systolic blood pressure at week 8 compared to baseline as measured by AOBP. The pre-planned analysis of the primary endpoint was an MMRM. Between Part 1 and Part 2, 100 mg QD, the pre-planned comparison of the primary endpoint was an unpaired two-tailed t-test using observed change from baseline to week 8. Secondary endpoints included change in ABPM from 24 hours per week 8 from baseline, change in diastolic blood pressure at week 8 from baseline, and proportion of subjects who met the blood pressure goal at week 8. To assess safety, results from the 100 mg QD cohorts of Parts 1 and 2 were pooled.

Phase 2 HTN-Targeted Clinical Trial Design

BID = twice daily; EOT = end of treatment; FU=aftercare; PRA = plasma renin activity; QD = once a day

efficiency

The results of the phase 2 proof-of-concept study of lorundrostat, as shown in the graph below, demonstrated efficacy across defined endpoints and were well tolerated at once-daily dosing.

The primary endpoint for Part 1 of Target-HTN was change from baseline in systolic blood pressure at week 8. As indicated in the table below, in an intention-to-treat analysis, lorundrostat showed a dose-dependent, statistically significant reduction in systolic blood pressure, which we consider to be clinically significant. Lorundrostat 50 mg and 100 mg once daily showed comparable reductions in systolic blood pressure compared to lorundrostat 12.5 mg or lorundrostat 25 mg twice daily. The higher once-daily and twice-daily doses of lorundrostat also resulted in a reduction in diastolic blood pressure over the course of the study, which we believe is clinically significant.

Target HTN efficacy data measured by AOBP

In Part 2, 31 patients with normal or elevated renin were treated with lorundrostat 100 mg once daily and assessed similarly to Part 1. The reduction in systolic blood pressure in Part 2 of this study was not statistically different from the reduction observed in Part 1 (see figure below). As a result, we believe lorundrostat has the potential to be effective across the full range of renin levels.

Individual blood pressure change in week 8

*N = subjects with baseline and week 8 data, mean modeled using FAS.

Another predefined objective of this study was to assess potential predictors of clinical response to lorundrostat. No consistent differences in clinical response to lorundrostat based on gender, race, age, or number of baseline antihypertensive drugs were observed. Our analysis of clinical outcomes showed that the following determinants are positively correlated with clinical response:

•Obesity. Hypertensive subjects with a BMI ≥ 30 kg/m2 showed a significant reduction in systolic blood pressure in part 1 of the study with a placebo-adjusted reduction of 16.7 mmHg at 50 mg QD and a reduction of 12.3 mmHg at 100 mg QD. In particular, the discovery of obesity supports our hypothesis of a link between the obesity-leptin-aldosterone axis and hypertension; And

•use of diuretics. Subjects taking a diuretic as part of their background therapy demonstrated a significant reduction in systolic blood pressure in Part 1 of the study with a placebo-adjusted reduction of 12.9 mmHg at 50 mg QD, 10.0 mmHg at 100 mg QD.

Placebo-adjusted improvement in systolic blood pressure by response determinant

During two study periods, the week before randomization and the last week of treatment with the study drug, the subjects had to wear a device that recorded blood pressure values ​​several times per hour for a period of 24 hours. This measurement provides a more complete picture of a patient's hypertension status than in-office measurements and eliminates the effects of the phenomenon known as "white coat hypertension," which occurs when blood pressure readings are higher in a healthcare professional's office than in other settings, z the home. The change in 24-hour systolic ABPM from baseline to week 7 or 8 for the 100 mg QD cohort of Part 1 showed an observed mean placebo-adjusted reduction in systolic blood pressure of 8.1 mmHg. The ABPM response to the 50 mg QD was complicated by evidence of "white coat" hypertension, but after elimination of data from subjects who were not hypertensive on ABPM, there was evidence of an observed mean reduction in placebo-corrected systolic blood pressure um 10.5 mmHg blood pressure in hypertensive subjects measured by ABPM (ABPM Hypertensive Set 50 mg QD). The mean overnight BP reduction in the 100 mg QD cohort was a placebo-adjusted mean observed reduction of 8.0 mmHg, and in the 50 mg QD group with hypertensive ABPM there was a placebo-adjusted mean observed reduction of 4.1 mmHg.

The also observed reduction in nocturnal blood pressure and restoration of sag are of potential relevance to the goal of reducing uHTN morbidity and mortality, since the association between elevated nocturnal blood pressure and cardiovascular risk has long been established in the medical literature.

A single subject in part 1 of target HTN demonstrated a reduction in mean 24-hour BP

The above reflects a treatment-responsive patient in Part 1 who received lorundrostat 100 mg QD (purple curve) from baseline (light blue curve), demonstrating a mean 24-hour BP reduction and restoration of normal nocturnal immersion pattern. Gaps in the traces represent missing measurements, which for technical reasons such as e.g. B. Cuff

Slide. Although not all patients have similar results, we believe the above data indicate one patient who responded positively to lorundrostat.

Central blood pressure is the pressure in the aorta, the large artery that carries blood from the heart throughout the body. Many experts believe that central blood pressure is a useful measure because central blood pressure can be a more accurate way of predicting whether a person will develop heart disease or a stroke. The central blood pressure reading in this test was acquired using the 24-hour ABPM through an integrated software package that measures the pulse waveform and thus obtains the central blood pressure measurements. As indicated below, lorundrostat at doses of 100 mg and 50 mg once daily demonstrated relevant reductions in central blood pressure that we consider clinically significant, with placebo-adjusted central systolic blood pressure reductions of 10.0 mmHg for 100 mg QD and 10.4 mmHg for ABPM kit for hypertensive QD 50 mg. The placebo-corrected reductions in central diastolic blood pressure were 5.9 mmHg for the 100 mg QD and 4.2 mmHg for the 50 mg QD hypertensive ABPM set.

Effect of lorundrostat on systolic and central systolic blood pressure

*Post hoc sensitivity analysis results relate to subjects who met quality control criteria and had both AOBP and ABPM > 130 mmHg.

eGFR measures how well a person's kidneys filter waste and extra water from the body through urine. In hypertensive patients, eGFR gradually decreases and individuals may begin to show signs and symptoms of chronic kidney disease at eGFR levels below 45 mL/min/1.73 m2. As shown in previous studies of antihypertensive drugs such as ACE inhibitors and ARBs, an initial reduction in eGFR in treated hypertensive patients may represent a positive benefit as it indicates a relieving of pressure in the glomerulus and potentially slows or halts progression to CKD. A dose-dependent reduction in eGFR was demonstrated in this study, which we believe is clinically significant and has the potential to provide a renal protective benefit that we plan to evaluate in future clinical trials.

security

Lorundrostat was found to be well tolerated, particularly with respect to four key factors that we believe are of particular interest when assessing the safety of lorundrostat:

•Cortisol Inhibition:As shown in the graph below, there was no clinically relevant suppression of cortisol production in either the serum cortisol test or the ACTH stimulation test. A slight increase in cortisol was observed in all cohorts, including placebo, but showed no trend above normal physiological levels;

No significant cortisol inhibition was observed on target HTN

Serum-Cortisol

•Hypotension (sitting systolic blood pressure < 100 mmHg):Hypotension and orthostatic hypotension were observed in three and three subjects, respectively, and were reversible, probably to be expected in relation to the study medication and based on the mechanism of action of lorundrostat;

•Hyponatraemia (Serum Sodium < 135 mmol/l):Severe hyponatraemia, possibly related to study drug, was observed in a patient with pre-existing hyponatraemia and was reversible upon drug discontinuation; And

•Hyperkalemia (Serum potassium > 5.1 mmol/L):There was an expected dose-dependent increase in serum potassium, although most subjects maintained serum potassium within the normal range. The two active once-daily doses resulted in a slight increase in potassium levels in the cohorts of 0.25 mmol/L at the 50 mg daily dose and 0.29 mmol/L at the 100 mg daily dose. Six subjects in the five active dose cohorts experienced one isolated case of elevated potassium greater than 6 mmol/L (two considered an artificial reading, three aggravated pre-existing hyperkalemia, and one was a confirmed episode of hyperkalemia). Consistent with the short terminal elimination half-life of lorundrostat, all episodes were rapidly reversible following protocol-performing dose reduction, temporary withdrawal of study drug, or discontinuation of treatment. An independent data safety monitoring panel raised no concerns about the effect of lorundrostat on serum potassium in the target HTN study.

Based on the totality of available data, there were no safety concerns that would result in changes to the BI or protocol. Three SAEs including one chest pain event, one peritoneal metastatic event and one hyponatraemia event were reported and treatment was discontinued. Hyponatraemia was assessed as possibly related to study drug. The other two events were assessed as unrelated to study drug. To date, the most frequently reported non-serious AEs, defined as events affecting five or more affected subjects, including the placebo group, were related to hyperkalemia - all determinations were above the upper limit of normal of 5.1 mmol/L (23.3%) , decreased glomerular filtration (6.8%), urinary tract infections (5.3%) and hypertension (3.8%). For some of the hyperkalemia events, study treatment was temporarily adjusted or permanently discontinued according to protocol safety guidelines.

pharmacokinetics

The 24-hour exposure/response ratio for systolic blood pressure at week 8 in all treatment groups suggests QD dosing up to 100 mg. The study results suggest a minimum effective dose of lorundrostat between 12.5 mg/24 hours and 25 mg/24 hours (12.5 mg BID) and a maximum effective dose of 50 mg to 100 mg once daily. All doses above 12.5 mg QD are active doses, which is to be expected. Given the relatively short half-life of lorundrostat, mean group exposure was similar in the 25 mg BID and 50 mg QD cohorts, indicating low drug accumulation. The comparable efficacy of the 25 mg BID and 50 mg QD cohorts suggests that once-daily dosing is sufficient to achieve maximal blood pressure reduction.

Exposure versus change in systolic blood pressure

Phase 1 clinical study results

The Lorundrostat Phase 1 program consisted of a randomized, double-blind, placebo-controlled, human-first study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses (MAD) of lorundrostat in healthy volunteers, including the impact of Gender and age on the pharmacokinetics of a single dose of lorundrostat in healthy volunteers. This study was conducted by Mitsubishi Tanabe in the Netherlands and the data from the study were used to support our open-label IND, which is part of our current lorundrostat development program. We introduced the IND in February 2021, which was cleared by the FDA in March 2021.

Lorundrostat was well tolerated in single and multiple doses in the first human study. No deaths or other SAEs were observed. One subject in the MAD Part 2 study, 360 mg dose group, discontinued treatment due to a treatment-emergent AE of sinus tachycardia. Across all cohorts, 9 of 87 (10.3%) lorundrostat-treated patients reported postural dizziness/dizziness compared to 1 of 29 (3.4%) placebo-treated patients.

The high selectivity of lorundrostat was demonstrated in the single ascending dose (SAD) and MAP portions of this study. Lorundrostat has been shown to reduce plasma aldosterone concentration in a dose-dependent manner in the SAD portion of the study, with a 36-77% reduction in 24-hour serum aldosterone over doses ranging from 5 mg to 800 mg. This finding was further validated in the MAD portion of the study with 40 mg, 120 mg and 360 mg reducing 24-hour serum aldosterone in a dose-dependent manner. In the SAD study, lorundrostat did not inhibit cortisol production across the dose range, and in the MAD study, cortisol was not inhibited even when cortisol was stimulated with adrenocorticotropic hormone (ACTH) on day 6. The results of this study demonstrated selectivity for aldosterone synthase with lorundrostat.

The effects on age and gender were also evaluated in the phase 1 program for lorundrostat. It was shown that none of these subgroups had differential exposure to lorundrostat.

A Phase 1, open-label, randomized, 2-sequence study evaluating the effect of food on the pharmacokinetics of lorundrostat in healthy volunteers has been completed. Based on the results of this study, lorundrostat can be administered with or without food in all ongoing and future clinical trials and post-approval in hypertensive patients.

We have also completed interaction studies of lorundrostat with metformin and esomeprazole. The metformin study was terminated due to a possible inhibition of the MATE1 pathway by lorundrostat. MATE1 is one of four metformin pathways. This study showed that lorundrostat had little effect on metformin and based on the minimal increases in metformin concentrations, lorundrostat would not be expected to be considered even a weak metformin inhibitor according to FDA definitions. The DDI study of esomeprazole was designed to evaluate the effect of varying gastric pH on lorundrostat absorption and availability. As predicted for lorundrostat, which is a weak base, there was reduced absorption in the alkaline gastric environment created by proton pump inhibitors (PPIs). Further studies are being conducted to provide labeling guidelines for meal timing or dose adjustment of lorundrostat for people using a PPI.

preclinical data

The pharmacological profile of lorundrostat was evaluated by in vitro pharmacological studies, which showed a selectivity ratio that was 374 times more selective for aldosterone inhibition than for cortisol inhibition. Lorundrostat inhibited hCYP11B2, the aldosterone pathway, and hCYP11B1, the cortisol pathway, with constant inhibitory values ​​of 1.27 nmol/L and 475 nmol/L, respectively.

Single-dose oral administration of lorundrostat significantly reduced plasma aldosterone concentration (PAC) in a non-human primate model of sodium deficiency. However, single-dose oral administration of lorundrostat did not affect CAPs in ACTH-loaded nonhuman primates, even at a dose 100-fold higher than the dose required to reduce CAP. These results indicate that lorundrostat inhibits CYP11B2 with greater selectivity over CYP11B1, an enzyme responsible for the production of cortisol.

Future clinical development plans

In November 2022, we held an end-of-phase 2 meeting with the FDA to (i) review the results of the Target-HTN study and (ii) discuss our plans for a foundational hypertension treatment program. The FDA agreed that the preclinical and clinical pharmacology plan supports an NDA, that the target HTN data support the main study program, and that the proposed dosing and clinical study designs would support an indication for hypertension. Based on the Phase 2 results and FDA feedback, we plan to initiate the lorundrostat flagship program below starting in 2023.

We plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in the first half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to baseline treatment of two or three antihypertensive drugs in up to about 240 adults. Patients will be randomized into three cohorts and treated for 12 weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and then titrated to 100 mg QD at week four or placebo. The primary endpoint of the study will be change in systolic blood pressure compared to placebo. Key data from this study is expected in the first half of 2024. We also plan to initiate a phase 3, randomized, double-blind, placebo-controlled study in the second half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN when used as add-on therapy to background treatment with two or more antihypertensive drugs in up to about 1,000 adults. The study is expected to be similar in design to the planned Phase 2 study described above. Primary data from this study are expected in mid-2025. We also plan to initiate a phase 2, randomized, double-blind, placebo-controlled study in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN a CKD Population with pivotal data from this study is expected in the first half of 2024. The pivotal program will include an open-label extension study open to all participants in the above studies.

Additional information

We also plan to expand development of lorundrostat into additional indications where abnormally elevated aldosterone is a key factor in disease pathology, including CKD. Uninhibited aldosterone is known to play a critical role in the progression of CKD, which affects more than 23 million people in the United States. We plan to initiate a phase 2 study in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN in a CKD population, with pivotal data from this study expected in the first half of 2024 become. Extension to other cardio-renal indications caused by abnormally elevated aldosterone.

Our team and investors

Founded in 2019 by Catalys Pacific, we are led by an experienced management team from diverse backgrounds with extensive experience in drug discovery, development and business building. Our management team consists of industry veterans with extensive experience at pharmaceutical companies such as Amgen, Aventis, Cephalon, Novartis, ProQR, Sanifit, Teva and Vertex. Collectively, our team has a proven track record of discovering, developing and commercializing a variety of approved therapeutics.

Since our inception, we have raised approximately $158 million in capital from various investors.

Mineralys license agreement with Mitsubishi Tanabe Pharma Corporation

In July 2020, we entered into a license agreement (the Mitsubishi License) with Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe), under which Mitsubishi Tanabe granted us an exclusive, worldwide, royalty-free, sublicensable license under Mitsubishi Tanabe's patent and other intellectual Proprietary rights to use products containing Lorundrostat (formerly MT-4129) (Lorundrostat Products) for the prevention, treatment, diagnosis, detection, monitoring or screening for predisposition to any indication, disease or condition in humans (the Territory). We will pay Mitsubishi Tanabe an initial royalty of $1.0 million and are obligated to pay Mitsubishi Tanabe development milestone payments totaling up to $9.0 million and commercial milestone payments totaling up to $155.0 million make first commercial sale and meet certain annual sales targets and additional commercial milestone payments of up to $10.0 million for a second referral. In addition, we are obligated to pay tiered royalties to Mitsubishi Tanabe in percentages ranging in the mid-single-digit percentage range up to ten percent (10%) of the total net sales of each lorundrostat product by lorundrostat product by lorundrostat product and country by country , up to (i) the expiration of Mitsubishi Tanabe's last valid patent claim for a Lorundrostat product, (ii) ten years from the first commercial sale of a Lorundrostat product, or (iii) the expiration of regulatory exclusivity in that country. These royalties can be reduced under certain conditions, including lack of patent coverage and generic competition.

We are committed to using commercially reasonable efforts to conduct and complete development activities and to seek regulatory approval for at least one lorundrostat product in a major market country and to consider in good faith the development of at least one lorundrostat product in a non-major market country to pull . If we sub-license our rights under the Mitsubishi license to use Lorundrostat or a Lorundrostat product in certain countries in Asia to a third party, Mitsubishi Tanabe will have the right of first sale for a specified period of time. We also agree not to market any competing product for a period of three years after the first commercial sale of the first Lorundrostat product in any country without Mitsubishi Tanabe's prior consent.

Unless terminated earlier, the Mitsubishi License will expire on expiry of all our royalty obligations to Mitsubishi Tanabe. We may terminate Mitsubishi's license without cause by giving 90 or 180 days' written notice to Mitsubishi Tanabe, depending on whether the Lorundrostat product has received regulatory approval. Mitsubishi Tanabe may terminate the Mitsubishi license if we fail to initiate regulatory consultation for the first global clinical trials of lorundrostat in at least one major market country within a specified period of time, or if we or our affiliates or sub-licensees initiate a patent rights challenge of Mitsubishi Tanabe licensed to us. In addition, either party may terminate the Mitsubishi License in the event of an unremedied material breach or bankruptcy of the other party, subject to certain notice and healing periods, or in the event of the other party's bankruptcy or insolvency.

manufacturing

We do not own or operate any manufacturing facilities for the manufacture of lorundrostat, nor do we have any plans to develop our own manufacturing facilities in the foreseeable future. We currently rely on external contract manufacturers for the raw materials we need, APIs and finished product candidates for our clinical trials. We currently have no contractual arrangements to manufacture commercial supplies of lorundrostat. We currently employ internal resources and outside consultants to manage our manufacturing suppliers.

sales and marketing

We have not yet determined our sales, marketing or product distribution strategy for lorundrostat as it is still in clinical development. Our commercial strategy may involve the use of strategic partners, distributors, contracted sales force or the establishment of our own sales force. We plan to continue evaluating these alternatives as we move closer to approval of lorundrostat, if available.

contest

The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary and novel products and product candidates. If approved, lorundrostat could serve multiple markets. Ultimately, the diseases that lorundrostat targets and for which it may receive marketing approval will determine our competition. There are competing programs being developed by other companies for our initial hypertension indication. If lorundrostat is approved, it must compete with existing therapies and new therapies that may become available in the future. We face potential competition from many different sources, including larger and better funded pharmaceutical, biopharmaceutical, biotechnology and therapeutic companies. In many cases, companies with competing programs have access to greater financial, technical, manufacturing, marketing, sales and supply resources, have more expertise and experience than we do, and may be more advanced in those programs. In addition, we may also compete with universities and other research institutions that may be conducting research in our target indications and are in direct competition with us. Smaller or young companies can also become important competitors, especially through cooperation agreements with large, established companies.

We believe our current and future competition can be divided into three broad categories:

•companies working to develop ASIs including Boehringer Ingelheim, CinCor, Damian Pharma and PhaseBio;

•companies with product candidates with different mechanisms of action, including Alnylam, Idorsia, Ionis, KBP BioSciences, Sihuan Pharmaceutical Holdings Group and Quantum Genomics; And

•Companies that market commodity antihypertensive drugs such as ACE inhibitors, ARBs, thiazide diuretics and calcium channel blockers, many of which are available generically at very low prices, including AstraZeneca, Johnson & Johnson, Merck, Novartis and Pfizer.

If we receive approval for lorundrostat or a future product candidate, we believe that the key competitive factors affecting the success of lorundrostat will be efficacy, safety, tolerability, convenience, price and the availability of government and other third country reimbursements . party pays for such competing products. Our business opportunity may be reduced or eliminated if your competitors have superior products in one or more of these categories.

Intellectual property

Intellectual property, including patents, trade secrets, trademarks and copyrights, is important to our business. Our commercial success depends in part on our ability to obtain and maintain proprietary intellectual property protection for our clinical-stage product candidate lorundrostat, as well as for future product candidates and new discoveries, product development technologies and know-how. Our business success also depends in part on our ability to act without infringing on the property rights of others and preventing others from doing so

violation of our property rights. Our policy is to develop and maintain protection of our proprietary position, including by licensing or filing US and foreign patents and applications relating to our candidate products, technologies, inventions and improvements important to the development and execution of our business are .

Our patent portfolio is constructed with the aim of providing broad protection, encompassing claims relating to the composition of matter, pharmaceutical compositions or formulations, methods of synthesis and methods of treatment using such compositions or pharmaceutical formulations, generally for the product candidate compound. We are seeking patent protection in the United States and in key foreign jurisdictions where we intend to commercialize lorundrostat. Our patent portfolio includes a combination of patents and patent applications owned exclusively by us, patents and pending patent applications licensed from Mitsubishi Tanabe Pharma Corporation or Mitsubishi Tanabe, and patent applications commonly owned by Mitsubishi Tanabe. As of December 2, 2022, our patent portfolio includes 9 different patent families protecting our technology related to lorundrostat and its synthetic intermediates, methods to synthesize lorundrostat and related compounds, various formulations of lorundrostat products, as well as methods to treat diseases with lorundrostat related composite products. As of December 2, 2022, our portfolio of exclusively licensed patents and pending patent applications consisted of four U.S. issued patents; a European patent that is registered in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Turkey and the United Kingdom has been validated; a European patent granted and validated in France, Germany, Italy, Spain and the United Kingdom; a pending European application; four issued Japanese patents; a granted Canadian patent; a granted Australian patent; a pending Brazilian order; a granted Chinese patent; a Granted Indian Patent; a granted Indonesian patent; a granted Korean patent; a granted Malaysian patent; one granted a Mexican patent; two Russian patents granted; a granted Singapore patent; a granted Taiwan patent; a pending Thai order; a granted Vietnamese patent; and a pending international PCT application.

Our portfolio of pending proprietary patent applications consists of one pending PCT international application and three pending US provisional patent applications.

Our portfolio of co-owned pending patent applications consists of one pending PCT international application and two pending US provisional patent applications.

The issued patents and pending applications in our portfolio of exclusively licensed patents and pending patent applications, if granted, have nominal expiration dates in the range of 2035 to about 2042, without accounting for any available patent term adjustments or extensions. Pending applications in our portfolio of pending wholly owned and jointly owned patent applications have nominal expiration dates in the range of 2041 to approximately 2042, without accounting for any available patent term adjustments or extensions. When patent applications are filed and subsequently granted claiming priority for pending US provisional applications in our portfolio of pending wholly and jointly owned patent applications, they have due dates in the range of 2042 to 2043, without considering any adjustments or extensions to available patent terms.

The term of individual patents in our portfolio depends on the legal term of the patents in the countries in which they were acquired. In most countries where we file applications, including the United States, the patent term is 20 years from the first filing date of a non-provisional patent application. In the United States, the term of a patent may be eligible for a patent term adjustment, which allows for a restoration of the patent term to compensate for delays experienced by the USPTO during the patent prosecution process. In addition, for patents covering an FDA-approved drug, the Drug Price Competition and Patent Term Restoration Act of 1984 or the Hatch-Waxman Act allows the patent term to be extended by up to five years after the patent expires. Although the length of the patent term extension is related to the length of time the drug is under regulatory review, the patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, but can only be limited to one year of patent per approved drug after the Hatch Waxman Act to be extended. Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent covering an approved drug. If our products receive FDA approval in the future, we look forward to applying for patent term extensions for those products. We plan to pursue any available patent term extensions for any issued patents that we may receive in any jurisdiction where such extensions are available; However, there is no guarantee that the relevant authorities, including the FDA, will

United States, will agree with our assessment as to whether such extensions should be granted and, if granted, the duration of such extensions.

The patent positions of companies like ours are generally uncertain and involve complex legal and factual issues. Relevant patent laws and their interpretation outside the United States are also uncertain. Changes in patent laws or their interpretation in the United States and other countries may limit our ability to protect our technology or candidate products and affect the value of that intellectual property. In particular, our ability to prevent third parties from making, using, selling, offering for sale, or importing products that infringe our intellectual property depends in part on our success in obtaining and enforcing patent claims covering our technology, inventions and cover improvements. We cannot guarantee that any patents will be granted in connection with any of our pending patent applications or in connection with any patent applications that we may file in the future, nor can we be assured that any patents that may be granted to us in the future will be granted will be commercially useful to protect our products, the methods of use, or the manufacture of those products. Furthermore, the granted patents do not guarantee the right to apply our technology in relation to the commercialization of our products. Granted patents only enable us to prevent potential competitors from practicing the inventions claimed in the granted patents.

In addition, patents and other intellectual property rights in the pharmaceutical and biotechnology fields are evolving and involve many risks and uncertainties. For example, third parties may have blocking patents that could be used to prevent us from commercializing our candidate products and practicing our proprietary technology, and our granted patents could be challenged, invalidated, or circumvented, which could limit our ability to compete with competitors prevent marketing. related products or may limit the duration of patent protection that might otherwise exist for our candidate products. In addition, the scope of rights granted under granted patents may not give us protection or a competitive advantage over competitors with similar technology. In addition, our competitors may independently develop similar technologies that fall outside the scope of rights granted under granted patents. For these reasons, we may face competition in relation to our product candidates. In addition, due to the long time required for the development, testing and regulatory review of a potential product, it is possible that patent protection for that product will expire or remain in effect before a particular product candidate can be commercialized for only a short period of time. Post-commercialization period, reducing the commercial benefit the patent provides.

We may also rely on trade secrets related to our discovery programs and product candidates and seek to protect and maintain the confidentiality of proprietary information to protect aspects of our business that are not patentable or that we do not deem appropriate. It is our policy to require our employees, consultants, external research associates, funded researchers and other advisors to sign non-disclosure agreements at the beginning of any employment or consulting contract with us, and for employees and consultants to enter into invention transfer agreements with us. These agreements provide that any confidential information developed or shared over the course of the individual's relationship with us is kept confidential and may only be disclosed to third parties in certain limited circumstances. The Agreements may provide that any inventions to which the Individual has contributed as inventor shall be transferred to us and as such become our property. However, there is no guarantee that these agreements will provide reasonable protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.

In addition, we seek and will continue to seek trademark protection for our company name and brand. As of December 27, 2022, we own four trademarks in the United States and other jurisdictions relating to the "MINERALYS" trademark.

Government Regulation

Government agencies in the United States, at the federal, state and local levels and in other countries extensively regulate, among other things, research, development, testing, manufacturing, quality control, licensing, labeling, packaging, storage, record keeping and advertising, advertising, sales, marketing and exporting and importing products like those we develop. A new drug must be approved by the FDA through the New Drug Application (NDA) process before it can be legally marketed in the United States.

Drug development process in the United States

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. The process of obtaining regulatory approvals and then complying with applicable federal, state, and local laws and regulations requires the investment of significant time and financial resources. The process required by the FDA before a drug can be marketed in the United States typically includes the following:

•Completion of pre-clinical laboratory testing, animal testing and formulation studies in accordance with Good Laboratory Practices (GLPs) and other applicable regulations;

•Submission of an IND to the FDA, which must be effective before human clinical trials can begin;

•Approval by an independent institutional review board (IRB) or ethics committee at each clinical site before each study can begin;

•Conducting appropriate and well-controlled human clinical trials in accordance with Good Clinical Practices (GCPs) to evaluate the safety and efficacy of the candidate product for its intended use;

•Submission of an NDA to the FDA upon completion of all pivotal studies;

•satisfactory completion of a review by an FDA Advisory Committee, if applicable;

•Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is manufactured to assess compliance with current Good Manufacturing Practices (cGMPs) requirements to ensure facilities, methods, and controls are adequate to verify identity, drug strength and quality and purity and possible inspection of selected clinical trial sites to assess compliance with GCPs; And

•FDA review and NDA clearance to allow commercialization of the product for certain indications in the United States.

Once a product candidate has been identified for development, it enters the pre-clinical testing phase. Preclinical testing includes laboratory evaluations of product chemistry, toxicity, and formulation, as well as animal testing. An IND sponsor is required to submit pre-clinical test results along with manufacturing information and analytical data to the FDA as part of an IND. An IND is an FDA application for approval to administer an investigational drug to humans. An IND also includes a protocol that includes, among other things, the objectives of the clinical study, the parameters to be used to monitor safety, and the efficacy criteria to be assessed if the study includes an efficacy assessment. Some pre-clinical testing may continue even after the IND has been submitted. The IND will automatically take effect 30 days after receipt by the FDA, unless the FDA suspends the clinical trial within the 30-day period. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical suspensions may also be imposed by the FDA at any time prior to or during clinical trials due to safety concerns about ongoing or planned clinical trials or non-compliance with specific FDA requirements, and trials may not begin or continue until FDA notifies the sponsor of the suspension was repealed.

All clinical trials must be conducted under the supervision of one or more investigators who are qualified under the GCPs, which include a requirement that all research participants provide written informed consent for their participation in any clinical trial. Clinical trials must be conducted according to protocols detailing the study objectives, dosing procedures, subject selection and exclusion criteria, and the safety and efficacy criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND, and a separate submission to the existing IND must be made for each successive clinical study conducted during product development and any subsequent protocol changes. Progress reports summarizing, among other things, the results of clinical studies and non-clinical studies conducted since the last progress report must be submitted while the IND is active

Submit to the FDA at least annually, and written IND safety reports must be submitted to the FDA and investigators for suspected unexpected and serious adverse events, findings from other studies that indicate a significant risk to people exposed to the same or similar drugs, findings from Animals are presented or in vitro tests suggesting a significant risk to humans and any clinically relevant increased incidence of a suspected serious adverse reaction compared to that listed in the investigator's protocol or package insert.

In addition, an independent IRB at each institution participating in the clinical trial must review and approve each protocol prior to the start of the clinical trial at that institution, and also approve the study information and consent form that must be provided to each study participant. or its legal representative, to accompany the study to completion and comply with IRB regulations. The FDA or sponsor may suspend a clinical trial at any time for a variety of reasons, including determining that subjects or patients are at an unacceptable risk to health. Likewise, an IRB may suspend or terminate approval of a clinical trial at its facility if the clinical trial is not being conducted in accordance with the requirements of the IRB or if the drug is associated with unexpected serious harm to patients. In addition, some clinical trials are monitored by an independent group of qualified experts organized by the sponsor and known as the Data Safety Monitoring Board or Committee. Depending on its bylaws, this group can determine whether a test can proceed based on access to specific test data at specific checkpoints. There are also requirements for reporting ongoing clinical trials and clinical trial results to public registries, including Clinicaltrials.gov.

Human clinical trials are typically conducted in three sequential phases, which may overlap or combine:

•Phase 1:The candidate product will first be introduced in healthy people and tested for safety, dose tolerance, absorption, metabolism, distribution and excretion and, where possible, to provide an early indication of its efficacy.

•Level 2:The candidate product will be administered to a limited population of patients with a specific disease or condition to identify potential side effects and safety issues, to preliminarily evaluate the candidate product's efficacy for specific target diseases, and to determine dosing tolerance and appropriate dosing.

•Phase 3:The candidate product will be administered to an expanded patient population to better assess dosing, provide substantial evidence of efficacy and improve assay safety, often across multiple geographically dispersed clinical trial sites. These clinical studies are designed to determine the overall benefit-risk balance of the candidate product and to provide an appropriate basis for product labeling.

Post-approval studies, sometimes referred to as phase 4 studies, can be conducted after initial marketing approval. These assays are used to gain additional experience in treating patients in the intended therapeutic indication. In certain cases, the FDA may require Phase 4 clinical trials to be conducted as a condition for approval of an NDA.

During the development of a new drug, sponsors have the opportunity to meet with the FDA at specific times. These points may be prior to filing an IND, at the end of Phase 2, and prior to filing an NDA. Appointments at other times can be requested. These meetings may provide an opportunity for the sponsor to share information about the data collected to date, provide advice to the FDA, and reach agreement between the sponsor and FDA on the next phase of development.

In parallel to clinical trials, companies often conduct additional animal testing and also need to develop additional information about the chemical and physical properties of the drug and complete a process to manufacture the product in commercial quantities according to cGMPs. The manufacturing process must be able to produce consistently high quality batches of candidate products and the manufacturer must develop methods to test the identity, strength, quality and purity of the final drug, among other things. In addition, appropriate packaging must be selected and tested, and stability studies must be performed to demonstrate that the candidate product will not undergo unacceptable deterioration during its shelf life.

US Review and Approval Process

The results of product development, pre-clinical and other non-clinical studies, and clinical studies, along with descriptions of the manufacturing process, analytical drug chemistry testing, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA for approval to market the product. Submitting an NDA is subject to the payment of significant user fees; a waiver of these fees may be obtained in certain limited circumstances.

The FDA conducts a preliminary review of all NDAs within the first 60 days of submission before accepting them for submission to determine whether they are complete enough to permit a substantive review. The FDA may request additional information instead of accepting an NDA for submission. In this case, the NDA must be resubmitted with the additional information. The resubmitted application will also be reviewed before the FDA accepts it for submission. After submission, the FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacture is cGMP compliant to ensure and preserve the product's identity, strength, quality, and purity. Under current Prescription Drug User Fee Act (PDUFA) guidance, the FDA has a 10-month target from the “registration date” of a standard NDA for a new molecular entity to review and respond to the submission. This review typically takes twelve months from the date the NDA is submitted to the FDA, as the FDA has approximately two months to make a "filing" decision after the application is submitted.

The FDA can refer an application for a new drug to an advisory committee. An Advisory Committee is a panel of independent experts, including physicians and other scientific experts, who review, evaluate and make recommendations as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but carefully considers those recommendations when making decisions. Before approving an NDA, the FDA typically inspects the facility or facilities where the product is manufactured. Additionally, prior to approving an NDA, the FDA may inspect one or more clinical trial sites to ensure compliance with GCPs.

After the FDA has evaluated an NDA and conducted inspections of the manufacturing facilities where the investigational device and/or its API are manufactured, the FDA may issue a letter of approval or a Complete Response Letter (CRL). A letter of approval authorizes commercial marketing of the drug with prescribing information for specific indications. A CRL indicates that the application review cycle is complete and the application is not approved in its current form. A CRL usually describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as: B. an additional clinical study or other significant and time-consuming requirements related to clinical studies, non-clinical studies or manufacturing. If a CRL is issued, the sponsor must either resubmit the NDA to correct any deficiencies identified in the letter or withdraw the application. Even if this data and information is presented, the FDA may decide that the NDA does not meet the approval criteria.

When a product receives regulatory approval, approval can be significantly restricted to specific diseases, dosages, or indications, which can limit the commercial value of the product. In addition, the FDA may require a sponsor to conduct Phase 4 trials, which are clinical trials to further evaluate a drug's safety and efficacy after NDA approval, and may establish testing and surveillance programs to monitor safety approved products have been marketed. The FDA may also impose other conditions on approval, including requiring a risk assessment and mitigation strategy (REMS) to ensure safe use of the drug. If the FDA concludes that a REMS is required, the NDA sponsor must submit a REMS proposal. If necessary, the FDA will not approve the NDA without an approved REMS. A REMS may include medication guides, physician communication plans, or elements to ensure safe use such as: E.g. restricted distribution methods, patient records and other risk reduction tools. Any of these licensing or marketing restrictions may restrict the commercial advertising, distribution, prescription, or distribution of products.

In addition, the Pediatric Research Equity Act (PREA) requires a sponsor to conduct pediatric clinical trials for most drugs for a new drug, indication, dosage form, dosing regimen, or route of administration. Under the PREA, original NDAs and supplements must include a pediatric evaluation unless the sponsor has received a deferral or waiver. The required evaluation should evaluate the safety and effectiveness of

the product for the claimed indications in all relevant pediatric subpopulations and supportive dosing and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA may request that pediatric clinical trials be deferred for some or all pediatric subpopulations. A delay may be granted for a variety of reasons, including determining that the drug is ready for approval for use in adults before pediatric clinical trials are complete, or that additional safety or efficacy data need to be collected before pediatric clinical trials begin. FDA is required to send a non-compliance letter to any sponsor who fails to submit the required evaluation, maintains a current deferral, or fails to submit an application for approval of a pediatric formulation.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA can grant orphan status to a drug intended to treat a rare disease or condition, d the United States there is no reasonable expectation that the cost of developing and delivering a drug in the United States for that type of disease or condition can be recouped through the sale of the product. Deportation as an orphan must be requested prior to filing an NDA. After the FDA grants orphan status, the identity of the therapeutic and its potential use as an orphan are publicly announced by the FDA. The orphan designation brings no advantage or shortens the duration of the regulatory review and approval process.

If an orphan-designated product subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA will not accept any further marketing applications for can approve orphan status. the same drug for the same disease or condition for seven years, except in certain circumstances, such as Such drug labeling also entitles you to financial incentives such as B. Funding Opportunities for Clinical Trial Costs, Tax Benefits, and User Fee Waiver. However, competitors may receive approval for different products for the indication for which the orphan product is exclusive, or they may receive approval for the same product but for a different indication for which the orphan product is exclusive. Orphan exclusivity may also block a competing product's approval for seven years if a competitor receives approval of "same drug," as defined by the FDA, or if a candidate product is found to be included in the competitor's product for the same disease it's on. In addition, if an orphan-designated product receives marketing authorization for a broader indication than that designated, it may not qualify for orphan exclusivity.

Accelerated development and review programs

The FDA has developed a number of programs to expedite the development or review of a new drug application. For example, the Fast Track Designation Program is designed to expedite or facilitate the process of developing and reviewing candidate products that meet certain criteria. In particular, investigational medicinal products are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and have the potential to address an unmet medical need for the disease or condition. The sponsor of a fast-track product candidate has an opportunity for more frequent interactions with the appropriate FDA review team during product development, and once an NDA is submitted, the product candidate may be eligible for priority review. With respect to a fast-track product candidate, the FDA may review the NDA review sections on an ongoing basis prior to submitting the full application if the sponsor provides a timeline for NDA section submission, the FDA agrees to accept sections of the NDA, and to determine that the schedule is acceptable and that Sponsor will pay any required usage fees upon filing Section One of the Non-Disclosure Agreement.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for a breakthrough therapy designation to expedite its development and testing. A product candidate may receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, will provide a substantial improvement over existing therapies in one or more clinically significant endpoints, such as: e.g. substantial treatment, can be observed early in clinical development. The appointment includes all of the features of the Fast Track program, as well as increased FDA interaction and consultation beginning as early as Phase 1, and an organizational commitment to accelerate the development and review of the product candidate, including senior executive involvement.

Any product candidate submitted to the FDA for approval, including a product candidate with a rapid or breakthrough designation, may also be eligible for other types of FDA programs designed to expedite development and review, such as: B. Priority Review and Accelerated Approval. An NDA is eligible for priority review if the candidate product is designed to treat a serious medical condition and, if approved, will provide a significant improvement in safety or efficacy compared to marketed products. The FDA will seek to allocate additional resources to the evaluation of a new drug application for priority review to facilitate review. The FDA aims to review applications with priority review designations within six months of the submission date, compared to 10 months for reviewing new NDAs for molecular agents under their current PDUFA review goals.

In addition, a product candidate may be eligible for accelerated approval. Drugs used to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval if the candidate product is determined to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint which can measure progression of irreversible morbidity or mortality that, taking into account the severity, rarity or prevalence of the disease and the availability or lack of alternative treatments, can predict with reasonable probability an impact on irreversible morbidity or mortality or other clinical benefit. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval conduct adequate and well-controlled confirmatory clinical trials. Drugs that receive accelerated approval may be subject to accelerated withdrawal procedures if the sponsor fails to conduct the required confirmatory studies in a timely manner or if such studies do not confirm the expected clinical benefit. In addition, the FDA currently requires pre-approval of promotional materials as a condition of expedited approval, which may adversely affect the timing of the product's commercial release.

Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval do not change approval standards but may expedite the development or approval process. Even if a candidate product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the eligibility requirements or decide that the period for FDA review or approval will not be reduced.

Post-Approval Requirements

All products manufactured or distributed pursuant to FDA approvals are subject to comprehensive and ongoing FDA regulations, including but not limited to record keeping, reporting of adverse experiences, periodic reporting, sampling and the Distribution of products and advertising and product promotion. Post approval, most changes to the approved product, such as the addition of new indications, certain manufacturing changes, and additional labeling claims, are subject to further review and approval by the FDA. Drug manufacturers and other facilities involved in the manufacture and distribution of approved medicines are required to register their facilities with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs and other laws and regulations. regulations . Changes to the manufacturing process are tightly regulated and, depending on the significance of the change, may require prior FDA approval before being implemented. As a result, manufacturers must continue to invest time, money and effort in the area of ​​production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

The FDA can withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems arise after the product is on the market. Subsequent discovery of previously unknown issues with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or non-compliance with regulatory requirements may result in revisions to approved labeling to add new safety information; Make requirements for post-marketing studies or clinical studies to evaluate new safety risks; or the imposition of any distribution restrictions or other restrictions under any REMS program. Other possible consequences include:

•restrictions on the sale or manufacture of the product, total withdrawal of the product from the market or recall of the product;

•Fines, warnings or untitled letters;

•clinical retentions in clinical trials;

•FDA refusal to approve pending applications or amendments to approved applications, or suspension or revocation of product approvals;

•confiscation or detention of any Products or refusal to import or export any Products;

•Consent Orders, Business Integrity Agreements, Exclusion or Exclusion from Federal Healthcare Programs;

•mandatory modification of promotional materials and labeling and issuance of correction information;

•issuing safety alerts, letters to honorable healthcare professionals, press releases and other communications containing warnings or other safety information about the product; or

•injunctions or the imposition of civil or criminal penalties.

In addition, the FDA strictly regulates the marketing, labeling, advertising, and promotion of drugs. A company may only make claims of safety and efficacy that have been approved by the FDA and are in compliance with approved labeling regulations. The FDA and other agencies actively enforce laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements may result in, among other things, negative publicity, warning letters, corrective publicity, and possible civil and criminal penalties. Physicians may prescribe legally available products for uses not described in product labeling that differ from those we have tested and FDA approved. These off-label uses are common across all medical specialties. Doctors may believe that such off-label uses are the best treatment for many patients in different circumstances. The FDA does not regulate the conduct of physicians in selecting treatments. However, the FDA restricts manufacturers' communication about the off-label use of their products.

Marketing exclusivity

Market exclusivity provisions under the FDCA may delay the submission or approval of certain marketing requests. The FDCA grants a five-year period of U.S. patent-free data exclusivity to the first applicant to receive approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved another new drug containing the same active ingredient, which is the molecule or ion responsible for the active ingredient's action. During the exclusivity period, the FDA may not accept for review an abbreviated application for marketing authorization (ANDA) or NDA submitted under Section 505(b)(2) (505(b)(2) NDA) by another company based on the same active part, regardless of whether the medicinal product is intended for the same indication as the original innovative medicinal product or for a different indication, if the applicant does not have the legal right to refer to all the data required for the authorisation. However, a request may be filed after four years if it includes certification of patent invalidity or non-infringement by the Innovator NDA holder of any of the FDA-listed patents.

The FDCA alternatively grants a three-year marketing exclusivity for an NDA or an addendum to an existing NDA if further clinical investigations in addition to bioavailability studies conducted or sponsored by the applicant are deemed by the FDA to be essential for approval of the drug application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug has been approved based on new clinical trials and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active ingredient for the original indication or contain the original condition of use. The five and three year exclusivity will not delay filing or approval of a full NDA. However, an applicant submitting a full NDA would need to conduct, or be granted the right to refer to, all preclinical studies and appropriate, well-controlled clinical studies needed to demonstrate safety and efficacy.

Pediatric exclusivity is another type of marketing exclusivity available in the United States. The pediatric exclusivity provides for an additional six months of marketing exclusivity tied to a different exclusivity period if

a sponsor is conducting clinical trials in children upon written request from the FDA. The issuance of a written application does not obligate the sponsor to conduct the clinical trials described.

Other Health Laws

Pharmaceutical companies are subject to additional health regulations and oversight by the federal government and by agencies in the states and foreign jurisdictions in which they conduct business and may limit the financial arrangements and relationships through which we research and sell, market and distribute any products, for which we receive market approval. These laws include, but are not limited to, federal and state laws against bribery, fraud and abuse, false claims, privacy and security, and transparency laws and regulations for physicians and other healthcare professionals. If our significant operations violate any of these laws or other applicable governmental regulations, they may be subject to penalties, including but not limited to administrative, civil and criminal penalties, damages, fines, restitution, reduction or restructuring of operations, surveillance integrity and reporting requirements, disqualification from participation in federal and state health programs, and imprisonment.

Coverage and Refund

The sale of a product is dependent in part on the extent to which that product is covered by third-party payers, such as federal, state, and foreign healthcare programs, commercial insurance, and managed healthcare organizations, and the level of reimbursement for that product from third-party payers. Decisions about the scope of coverage and the amount of reimbursement to be made are made on a plan-by-plan basis. The process of determining coverage is often a time-consuming and expensive process that requires us to provide scientific and clinical support for the use of our products to each payer separately, with no guarantee that adequate coverage and reimbursement will be achieved. These third-party payers are increasingly reducing reimbursements for medical products, drugs and services. In addition, the US, state and foreign governments continued to implement cost containment programs, including price controls, coverage and reimbursement limitations, and generic substitution requirements. The imposition of price controls and cost containment measures, as well as the imposition of more restrictive policies in jurisdictions with existing controls and measures, may further limit the sale of products. A decrease in third-party reimbursement for a product, or a decision by a third-party payer not to cover a product, could reduce physician use of the product and patient demand for the product, and also have a material adverse effect on sales.

healthcare reform

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act, each as amended, collectively known as the ACA, was enacted, which regulates the way healthcare is funded by government and private insurers , has fundamentally changed. , and significantly impacted the pharmaceutical industry. The ACA contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments, and changes to fraud and abuse laws. For example the AKA:

•increased the minimum amount of Medicaid rebates payable by branded drug manufacturers from 15.1% to 23.1% of the average manufacturer price;

•mandatory collection of drug rebates paid by Medicaid managed care organizations;

•Manufacturers are required to participate in a coverage gap rebate program, under which they must agree to offer eligible beneficiaries a 70% discount at the point of sale on the negotiated prices of the relevant branded drugs during the coverage gap period Part D to be covered; And

•imposed a nondeductible annual fee on pharmaceutical manufacturers or importers who sell "branded prescription drugs" to certain federal government programs.

Since the ACA was enacted, other legislative changes have been proposed and adopted in the United States. On March 11, 2021, the American Rescue Plan Act of 2021 was enacted, eliminating the statutory Medicaid drug rebate cap, currently set at 100% of a drug's average manufacturer price, or AMP, effective January 1, 2024. More recently On August 16, 2022, the Inflation Reduction Act of 2022 or IRA came into effect. Among other things, the IRA requires manufacturers of certain drugs to negotiate prices with Medicare (from 2026), with a cap on the negotiable prices; imposes rebates on Medicare Part B and Medicare Part D to penalize rate increases that exceed inflation (first due in 2023); and replaces the coverage gap rebate program in Part D with a new rebate program (coming in 2025). The IRA allows the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance rather than regulation for the first few years. For this and other reasons, it is currently unclear how the IRA will be affected.

Additionally, of late, the manner in which manufacturers set the prices of their marketed products has come under increased government scrutiny, leading to multiple investigations by Congress, proposed and enacted legislation, and executive orders issued by the President that, among other things, aim to bring more transparency to product pricing, review the relationship between pricing and manufacturers' patient programs, and reform reimbursement methods for government drug programs. It is also possible that additional government measures will be taken in response to the COVID-19 pandemic. Individual states in the United States have also become increasingly active in enforcing regulations controlling the price of pharmaceutical products, including patient price or reimbursement restrictions, rebates, restrictions on access to certain products, and disclosure of marketing costs and activities. in some cases to encourage imports from other countries and bulk purchases.

Employees

As of December 15, 2022, we have 12 full-time employees, eight of whom are mainly involved in research and development. None of our employees are represented by a union and we consider our employee relations to be good.

Legal Actions

We are not currently involved in any relevant proceedings. From time to time, we may become involved in legal proceedings arising out of our normal course of business. Regardless of the outcome, litigation could adversely affect us due to defense and settlement costs, diversion of administrative resources, negative publicity, reputational damage and other factors.

company information

We were incorporated in May 2019 as Catalys SC1, Inc. under the laws of the State of Delaware. and subsequently changed our name to Mineralys Therapeutics, Inc. Our mailing address is 150 N. Radnor Chester Rd, Suite F200, Radnor, PA 19087 and our telephone number is 888-378-6240. We also maintain a website at www.mineralystx.com. The information contained on or accessible through our website does not form part of this prospectus. We only include our website address as an inactive text notice.

MANAGEMENT

Executive Directors and Advisors

The following table shows the name, age and title of each of our officers and directors as of February 1, 2023:

__________________

(1)Member of the Compensation Committee.

(2)Member of the Audit Committee.

(3)Mitglied des Nominating and Governance Committee.

Managing Director

Jon Congletonhas been our Chief Executive Officer and a member of our Board of Directors since November 2020. Before joining us, Mr. Congleton was CEO of Impel NeuroPharma, Inc. from September 2017 to May 2020. Prior to that he was CEO and Director of Nivalis Therapeutics, Inc. from January 2015 to February 2017. Mr. Congleton previously worked at Teva Pharmaceutical Industries, Ltd. (Teva), where he held general management and global strategic marketing positions for more than 18 years, including Senior Vice President, Global Central Nervous System Disorders at Teva from April 2013 to December 2014, Senior Vice President, Global Medicine Group from November 2011 to April 2013 and Managing Director of Teva Neuroscience, Inc. in the United States. Prior to joining Teva, Mr. Congleton spent ten years in various commercial positions at Sanofi's predecessor companies. Congleton earned a B.S. in Marketing from Kansas State University. Mr. Congleton's knowledge of our business and his extensive leadership experience at various biopharmaceutical companies contributed to our board's conclusion that he should serve as a director of our company.

Adam Levyhas been our Chief Financial Officer and Chief Business Officer since March 2022 and Secretary since January 2023. Before joining Mineralys, he was Chief Financial Officer for Sanifit Therapeutics until the company was acquired by Vifor Pharma in 2022. Adam previously served as Chief Business Officer for Brickell Biotech from 2019 to 2020, leading the transition of the organization's financial operations when it became a public company on Nasdaq. Prior to that, he served as Chief Business Officer for miRagen Therapeutics from 2016 to 2019, where he was responsible for a variety of roles including financial strategy, investor relations, business development, legal affairs, intellectual property, project and program management, and human resources. . Between 2000 and 2016 Mr. Levy has held various investment banking positions at Merrill Lynch, Jefferies Group and Wedbush Securities. Mr. Levy received a B.S. in Business Administration and Marketing from Cornell University.

David Rodman, MDhas been our Chief Medical Officer since January 2021. Previously Dr. Rodman has held various roles at miRagen, Vertex Pharmaceuticals Inc. and Novartis Institute for BioMedical Research. The doctor. Rodman was elected to the American Society for Clinical Investigation and was named an Established Investigator and Fellow of the American Heart Association. The doctor. Rodman earned a medical degree from the University of

Pennsylvania and was later certified by the University of Colorado in internal medicine, pulmonary medicine, and critical care medicine.

Non-Employee Directors

Brian Taylor „BT“ Slingsby, MD, Ph.D., MPHfounded Mineralys on May 31, 2019 and has been a member of our Board of Directors since thenthen andas executive chairman. Physician Slingsby is the founder and managing partner of Catalys Pacific, a life sciences venture capital firm. dr Slingsby was founding CEO of Pathalys Pharma, Inc., Kirilys Therapeutics, Inc. and Aculys Pharma, KK. Prior to Catalys Pacific, he founded the Global Health Innovative Technology Fund, the world's first public-private fund focused on developing new medicines for low- and middle-income countries. Slingsby graduated from Brown University with honors, earned his M.P.H. and Ph.D. from Kyoto University and the University of Tokyo and received his M.D. with honors from George Washington University. The investment experience of Dr. Slingsby's history in the biopharmaceutical industry, along with his academic background and experience on various boards of public and private companies, contributed to our board's conclusion that he should serve as a director of our company.

Srinivas Akkaraju, MD, Ph.D. has been a member of our board ever sinceFebruary 2021. The doctor. Akkaraju has been a general partner of Samsara BioCapital, a venture capital firm, since the firm's inception in 2017. From April 2013 to March 2017, Dr. Akkaraju was General Partner and then Senior Consultant at Sofinnova Ventures, a venture capital firm focused on the life sciences industry. From January 2009 to April 2013, Dr. Akkaraju was the managing director of New Leaf Venture Partners, an investment firm focused on the healthcare technology sector. From 2006 to 2008 Dr. Akkaraju was the managing director of Panorama Capital, a venture capital firm he co-founded with other members of J.P. Morgan Partners, a private equity division of JPMorgan Chase & Co. Prior to co-founding Panorama Capital, Dr. Akkaraju worked at J.P. Morgan Partners, where he joined in 2001 and became a partner in 2005. From 1998 to 2001 Dr. Akkaraju worked in business and corporate development at Genentech, Inc. (now a member of the Roche Group), a biotechnology company. Doctor Akkaraju has been a director of publicly traded biopharmaceutical companies Intercept Pharmaceuticals, Jiya Acquisition Corp. since October 2012. (where he also serves as President) since November 2020 and Syros Pharmaceuticals, Inc. on the board of directors of several private companies. In the past five years, Dr. Akkaraju was previously a director of Aravive, Inc. (formerly Versartis, Inc.), Tyr Pharma, Inc., Principia Biopharma Inc. and Seattle Genetics, Inc. (now Seagen Inc.). Doctor Akkaraju received his M.D. and a Ph.D. in Immunology from Stanford University and BA in Biochemistry and Computer Science from Rice University. The extensive investment experience of Dr. Akkaraju's background in the biopharmaceutical industry, as well as his scientific background and experience on various boards of public and private companies contributed to our board's conclusion that he should serve as a director of our company.

Alexander Asam, Ph.D. has been a member of our board ever sinceFebruary 2021. Since 2007 dr. Asam is an investment advisor at HBM Partners and brings over 20 years of life sciences and private equity experience to the table. From 2001 to 2007 he was a former managing director and partner of Deutsche Venture Capital / Deutsche Bank and held various positions at Hoechst AG, Aventis S.A. (now: Sanofi) and LION Bioscience AG as well as member of the IPO Core Team (double list Germany and USA). He is a board member of 1000Farmacia Research and board observer for Swixx Biopharma and Aculys. Asam served on the board of directors of publicly traded Arcutis Biotherapeutics from October 2019 to October 2020. dr and Ph.D. in chemistry from the University of Heidelberg. The great experience of Dr. Asam in the life sciences industry, including as an investor and board member, contributed to our board's conclusion that he should serve as a director of our company.

Derek DiRocco, Ph.D. has been a member of our board ever sinceJune 2022. The doctor. DiRocco has been a partner at RA Capital Management, L.P., a tiered investment manager dedicated to evidence-based investments in healthcare and life sciences companies developing drugs, medical devices and diagnostics, since December 2020 and was previously a Director from December 2017 to December 2020, an Analyst from June 2015 to December 2017 and Associate from July 2013 to June 2015. Dr. DiRocco served on the board of directors of

Iteos Therapeutics, Inc. as of March 2020 and 89bio, Inc. as of April 2018, each of which are public biotechnology companies. Physician DiRocco also serves on the boards of directors of several private biotechnology companies. Doctor DiRocco has a B.A. in Biology from the College of the Holy Cross and a Ph.D. in Pharmacology from the University of Washington. He was a postdoctoral researcher at Brigham and Women's Hospital/Harvard Medical School. The many years of investment experience of Dr. DiRocco's background in biopharmaceutical companies, coupled with his academic background and experience serving on the boards of public companies, contributed to our board's conclusion that he should serve as a director of our company.

Olivier Litzka, Ph.D. has been a member of our board since June2022. The doctor. Litzka has been a partner at Andera Partners, a venture capital firm, since 2006 and began his commercial career in 1998 at Mercer Management Consulting. In 2000 he joined 3i Group plc with a focus on investments in biopharmaceuticals and medical devices. Doctor Litzka currently serves on the boards of directors at MMI Microsystems, T-Knife, Allecra Therapeutics, HighLife Medical, MedLumics, Tricares and JenaValve. He was also a board member of Corvidia, Sapiens, Endosense, Novexel, Supersonic Imagine and Arvelle Therapeutics prior to their respective acquisitions. Doctor Litzka has a Ph.D. in molecular microbiology at the Institute for Genetics and Microbiology in Munich. The extensive investment experience of Dr. Litzka in the biopharmaceutical industry contributed to our board's conclusion that he should serve as a director of our company.

Takeshi Takahashi, MBA has been a member of our board ever sinceMay 2020. Mr. Takahashi is a managing partner at Catalys Pacific, a position he has held ever since2019. Prior to Catalys Pacific, he was an investment banker at Morgan Stanley for 12 years. Before joining Morgan Stanley, he worked in the wealth management division of Merrill Lynch. Mr. Takahashi received a BA from Waseda University in Political Science and Economics and an MBA from the Kellogg School of Management at Northwestern University. Mr. Takahashi in the biopharmaceutical industry contributed to our board's conclusion that he should serve as a director of our company.

family relationships

There are no family ties between our officers or directors.

Composition of the board and election of the board

Independence of the director

Our board currently consists of seven members. Our Board of Directors has determined that all of our officers, with the exception of Mr. Congleton, are independent directors under the listing requirements of the Nasdaq Global Market (Nasdaq). The Nasdaq definition of independence includes a number of objective tests, including that the director is not one of our employees and has not been for at least three years, and that neither the director nor his family members have had any involvement with us. In addition, as required by Nasdaq Rules, our Board of Directors has determined subjectively for each independent director that there are no relationships that, in the opinion of our Board of Directors, would interfere with the exercise of independent judgment in the exercise of the director's responsibilities. In making these determinations, our Board of Directors reviewed and discussed information provided by the Directors and us regarding each Director's business and personal activities and relationships that may relate to us and our management. There are no family ties between our directors or officers.

Classified board

Pursuant to the terms of our Amended and Consolidated Articles of Incorporation, effective immediately prior to the closing of this Offering, our Board of Directors will be divided into three classes with staggered three-year terms. At each annual general meeting of shareholders, directors whose term of office is about to expire may be re-elected until the third annual meeting after re-election. At the conclusion of this offer, our consultants are divided into the following three classes:

•The Class I directors will be Mr. Asam, Mr. Congleton and Mr. Takahashi, and their term of office will expire at our first annual general meeting following this offer;

•The Class II directors will be Mr. DiRocco and Mr. Litzka and their term will expire at our second annual general meeting following this offering; And

•Class III principals will be Dr. Akkaraju and Dr. Slingsby, and its term will expire at our third annual shareholders' meeting following this offering.

Our Amended and Consolidated Articles of Incorporation, effective immediately prior to the closing of this Offering, provide that the authorized number of directors may be changed only by resolution of the Board of Directors. Any additional directorships resulting from an increase in the number of Directors will be distributed among the three classes so that, to the extent possible, each class will consist of one-third of the Directors. Dividing our Board of Directors into three classes with staggered three-year terms could delay or prevent a change in our Board of Directors or a change in control of our business. Our directors may only be removed for cause by the affirmative vote of holders of at least two-thirds of our voting stock, who are then entitled to vote at a directors' election.

Management structure of the Board of Directors

Our Board of Directors is currently led by Dr. Slingsby. Our Board recognizes the importance of determining an optimal board governance structure to ensure independent oversight of management as the Company continues to grow. We have separated the roles of CEO and Chairman of the Board, recognizing the differences between the two roles. The Chief Executive Officer is responsible for setting our company's strategic direction and for the day-to-day leadership and performance of our company, while the Chief Executive Officer guides the Chief Executive Officer and chairs board meetings. We believe this separation of responsibilities provides a balanced approach to leading the Board and overseeing our business. Our Board of Directors has concluded that our current governance structure is appropriate at this time. However, our Board will continue to regularly review our governance structure and make any changes it deems appropriate going forward.

Role of the board of directors in the risk oversight process

Our Board of Directors is responsible for overseeing our risk management processes and, as a whole or through its committees, regularly discusses with management our key risks, their potential impact on our business and the actions we have taken to address them. The risk oversight process includes receiving regular reports from board committees and senior management to enable our board to review our risk identification, risk management and risk mitigation strategies in relation to areas of potential material risk, including operational, financial, legal, regulatory, strategic and reputational risk.

The Audit Committee reviews liquidity and operational information and oversees our financial risk management. The Audit Committee regularly reviews our policies related to risk assessment, risk management, loss prevention and regulatory compliance. The Audit Committee's oversight includes communicating directly with our external auditors and discussing with management about significant risks and the actions taken by management to limit, monitor or control such risks. The Compensation Committee is responsible for assessing whether any of our compensation policies or programs have the potential to encourage excessive risk-taking. The Nominating and Corporate Governance Committee manages risks related to the independence of the Board of Directors, the Company's disclosure practices and potential conflicts of interest. While each committee is responsible for evaluating specific risks and overseeing the management of those risks, the full Board is regularly informed of those risks through committee reports. Matters of significant strategic risk are reviewed by our Board as a whole.

Board and Independence Committees

Our Board of Directors has established three standing committees – Audit, Compensation and Nominating and Corporate Governance – each of which operates in accordance with the Articles of Association approved by our Board of Directors.

financial advice

The primary responsibility of the Audit Committee is to oversee our accounting and financial reporting processes and the audits of our financial statements. The tasks of this committee include:

•Identify our independent registered accounting firm;

•evaluating the qualifications, independence and performance of our independent accounting firm;

•Approval of audit and non-audit services to be performed by our independent accounting firm;

•review the design, implementation, adequacy and effectiveness of our internal accounting controls and our critical accounting policies;

•discuss with management and the registered independent accounting firm the results of our annual audit and review of our unaudited quarterly financial statements;

•review, oversee and monitor the integrity of our financial statements and our compliance with legal and regulatory requirements relating to financial statements or accounting matters;

•review each investment policy periodically or as appropriate and recommend changes to that investment policy to our board of directors;

•review with management and our auditors all earnings reports and other public disclosures relating to the results of our operations;

•prepare the report required by the SEC in our annual proxy statement;

•Review and approve all related party transactions and review and monitor compliance with our Code of Business Conduct and Ethics; And

•review and evaluate at least annually the performance of the Audit Committee and its members, including the Audit Committee's compliance with its charter.

The members of our audit committee are Mr. DiRocco, Mr. Litzka and Dr. Asam. Mr. DiRocco serves as the chair of the committee. All members of our Audit Committee meet the financial competency requirements of applicable SEC and Nasdaq rules and regulations. Our Board of Directors has determined that Mr. Litzka is an Audit Committee Financial Expert for the purposes of applicable SEC rules and has the requisite financial experience as defined by applicable Nasdaq listing standards. Our board of directors has decided that Mr. DiRocco, Mr. Litzka and Dr. Asam is independent under applicable SEC and Nasdaq rules. Upon the listing of our common stock on the Nasdaq, the Audit Committee will operate under written charter that conforms to applicable SEC and Nasdaq standards.

Compensation Committee

Our Compensation Committee approves policies regarding the compensation and performance of our directors and employees. The Compensation Committee approves the relevant corporate objectives and objectives for the compensation of our Chief Executive Officer and other senior executives, evaluates the performance of those directors in light of those objectives and objectives, and approves those directors' compensation based on those assessments. The Compensation Committee also approves the issuance of stock options and other awards under our stock plans. The Compensation Committee reviews and evaluates at least annually the performance of the Compensation Committee and its members, including the Compensation Committee's compliance with its charter.

The members of our Compensation Committee are Dr. Akkaraju, Takahashi-san and DiRocco-san. The doctor. Akkaraju serves as the chairman of the committee. Our Board of Directors has decided that Dr. Akkaraju and Mr. Takahashi is independent and “not employees” under applicable Nasdaq listing standards.

Director” within the meaning of Rule 16b-3 of the Stock Exchange Act. Upon the listing of our common stock on the Nasdaq, the Compensation Committee will operate under a written charter, which the Compensation Committee will review and evaluate at least annually.

Nominating and Corporate Governance Committee

The Nominating and Corporate Governance Committee is responsible for assisting our Board of Directors in fulfilling the duties of the Board of Directors related to identifying qualified candidates for membership of the Board, selecting candidates for election as directors of our annual shareholders' meetings (or extraordinary shareholders' meetings at which directors are elected) and the selection of candidates to fill vacancies on our board and committees. In addition, the Nominating and Corporate Governance Committee is responsible for overseeing our corporate governance policies, reporting to our Board of Directors and making recommendations on governance matters, reviewing the Board and assisting it in the oversight of matters related to environmental, social and governance issues related to the company and overseeing the assessment of our Board of Directors. The members of our Nominating and Corporate Governance Committee are Dr. Slingsby, Sr. Asam and Dr. Akkaraju. The doctor. Slingsby serves as chairman of the committee. Our Board of Directors has determined that each of Dr. Slingsby, Mr. Asam and Dr. Akkaraju is independent under applicable Nasdaq listing standards. Upon the listing of our common stock on the Nasdaq, the Nominating and Corporate Governance Committee will operate under a written charter, which the Nominating and Corporate Governance Committee will review and evaluate at least annually.

Compensation and privileged participation committee locks

None of the members of our Compensation Committee have ever been one of our directors or employees. None of our officers currently serve or have served on the board or compensation committee of any company that has one or more officers serving on our board or compensation committee.

board variety

Upon completion of this offering, our Nominating and Corporate Governance Committee will be responsible for reviewing annually with the Board the appropriate qualities, skills and experience required of the Board as a whole and its individual members. In evaluating the suitability of individual candidates (both new candidates and current members) for election or appointment, the Nominating and Corporate Governance Committee and the Board will consider many factors, including the following:

•integrity, ethics and personal and professional values;

•experience in corporate management, as a director or former director of a public company;

•experience as a director or officer of another public company;

•strong experience in finance;

•Diversity of expertise and experience on material matters affecting our business compared to other Board members;

•diversity of backgrounds and perspectives, including but not limited to age, gender, race, location and professional experience;

•industry-relevant experience with relevant socio-political issues; And

•relevant academic experience or other knowledge in an area of ​​our business.

Our Board is currently evaluating each individual in the context of the Board as a whole, with the goal of forming a group that can do the best, following the completion of this offering

Maximize the success of the company and represent the interests of shareholders by drawing on their diverse experience in these different areas with good judgment.

Code of Business Conduct and Ethics

We have adopted a written Code of Business Conduct and Ethics applicable to our directors, officers and employees, including our chief executive officer, chief financial officer, chief financial officer or controller or anyone holding a similar role, which is effective upon the completion of in This offer comes into force. After this offer expires, our Code of Conduct and Ethics in Corporate Governance will be available on our website atwww.mineralystx.com. In addition, we intend to make any disclosures required by law or Nasdaq listing standards regarding changes to or waivers of provisions of the Code on our website. We include our website address in this prospectus as an inactive text reference only. Reference to our website address does not constitute an incorporation by reference of any information contained on or available through our website and you should not consider it a part of this Prospectus.

EXECUTIVE AND DIRECTORS' COMPENSATION

overview

Our 2022 Executive Director nominees, made up of each person who served as our Chief Executive Officer in 2022 and our next two highest paid Executive Directors in 2022, were:

•Jon Congleton, CEO;

•Adam Levy, CFO, commercial director and secretary; And

•David Rodman, MD, Chief Medical Officer.

This discussion may contain forward-looking statements that are based on our current plans, considerations, expectations and decisions regarding future compensation programs. The actual compensation programs that we have adopted after the closing of this offering could differ materially from the currently planned programs summarized in this discussion.

The following table provides information on the compensation earned by our appointed officers in connection with the fiscal years ended December 31, 2022 and 2021.

Summary table of remuneration 2022

__________________

(1)The amounts for FY 2021 reflect one-time bonuses granted to our appointed Executive Directors under the terms of their offer letters to the Company.

(2)Amounts reported in the “Option Awards” column represent the aggregate grant date fair value of stock options granted during the relevant year, calculated in accordance with the Financial Accounting Standards Board or FASB, Accounting Standards Codification or ASC, Topic 718. The Assumptions , used in the grant date fair value calculation of the awards reported in this column are set out in the notes2e8to our audited financial statements, which are included elsewhere in this prospectus. The amounts reported in this column reflect the book cost of the stock options and do not reflect the actual economic value realized by the executive in acquiring the stock options, exercising the stock options, or selling common stock underlying such awards. See “—Summary of Salary Schedule—Equity Based Incentives”.

(3)The amounts reported in the “Holdings in shares” column represent the aggregate grant date fair value of the restricted stock awards granted during the relevant year, calculated in accordance with FASB ASC Topic 718. The assumptions used in calculating these amounts are included in Note 5 to our Combined Financial Statements, which appears elsewhere in this Prospectus. The assumptions used in the calculation of the grant date fair value of the awards disclosed in this column are set out in Notes 2 and 8 to our audited financial statements, which are included elsewhere in this Prospectus. The amounts reported in this column reflect the accounting expense for the restricted stock awards and do not reflect the actual economic value realized by the executive in acquiring the restricted stock awards or in selling the common stock underlying those awards. See “—Summary of Salary Schedule—Equity Based Incentives”.

(4)Fiscal year 2021 figures reflect performance bonuses earned by each executive in 2021 and paid in early 2022.

(5)The amounts reflect the company's corresponding contributions to a 401(k) savings plan.

(6)Bonus amounts for 2022 are not calculable as of the date of this prospectus. Bonus amounts for 2022 are expected to be determined in Q1 2023 when the Company discloses those bonus amounts.

(7)From March 1st, 2022 Mr. Congleton increased from $400,000 to $420,000.

(8)Mr. Levy joined us as Chief Financial Officer and Chief Business Officer in March 2022 and therefore the base salary amount shown in the table above reflects the amount he earned during the portion of 2022 that he was with us . Mr. Levy's annual base salary as of 2022 was $415,000.

(9)From March 1st, 2022, Dr. Rodman raised from $395,000 to $414,750.

Narration for the summary compensation table

Annual Base Salary

The compensation of our appointed executive officers is generally determined and approved by our Board of Directors. In 2021 Mr. Congleton as our CEO and Dr. Rodman to serve as our medical director was $400,000 and $395,000, respectively, which increased to $420,000 and $414,750, respectively, effective March 1. , 2022. In 2022, Mr. Dues for service as our Chief Financial Officer and Chief Business Officer was $415,000.

annual bonus

In addition to base salaries, our appointed officers are eligible for annual performance-related cash awards, which are designed to provide appropriate incentives for our executives to achieve defined annual corporate goals and to reward our executives for the individual achievement of those goals. The annual performance bonus to which each nominated Executive Director is entitled is generally based on the extent to which we meet the corporate objectives that our Board of Directors sets each year. At the end of the year, our Board of Directors reviews our performance against each corporate objective and determines the extent to which we have achieved each of our corporate objectives.

Our Board of Directors will generally consider each appointed Executive Officer's individual contribution to the achievement of our annual corporate objectives. For 2022 Mr. Congleton and Dr. Rodman were eligible to receive an annual target bonus for 2022 equal to 25% of their respective annual base salaries. For 2022 Mr. Levy was entitled to an annual target bonus for 2022 equal to 40% of his annual base salary.

The corporate goals set by the Board of Directors for 2022 related to clinical, non-clinical, regulatory, drug and product manufacturing, business development and funding milestones. The bonuses for the respective year are generally determined and paid out in the first quarter of the following year. Accordingly, as of the filing date of this Prospectus, the 2022 Executive Bonus Compensation has not yet been determined.

Equity-Based Incentive Awards

Our stock-based incentive awards are designed to align our interests and those of our shareholders with those of our employees, including our officers. The Board of Directors, or a committee authorized by it, is responsible for approving capital grants.

Prior to this offering, we granted stock options and issued restricted stock under our 2020 amended and restated stock incentive plan (the 2020 Plan). Following this offering, we will award stock awards in accordance with our 2023 Plan. The terms of our stock plans are described in the “Stock Incentive Plans” subsection below.

In March 2022, our Board of Directors granted 172,444 restricted shares to Mr. Elevate under our 2020 Plan. Restricted shares will vest in respect of 25% of the shares on the first anniversary of commencement on March 10, 2022 and the remaining shares will vest in substantially equal monthly installments for 36 months, subject to Mr. Levy's continued service with us from each date of purchase.

In July 2022, our Board of Directors granted 575,270 and 172,117 restricted shares under our 2020 Plan to Mr. Congleton and Mr. Levi, respectively. The restricted shares were originally scheduled to vest in respect of 25% of the shares on the one-year anniversary of the exercise dates of July 12, 2022 and 10 March 2022 and the remaining shares were originally intended to be acquired in substantially equal installments for 36 months thereafter, subject to the continuation of the relevant executive offer agreed with us from each acquisition date.

In July 2022, our Board of Directors granted Dr. Rodman. The option has an exercise price of $1.08 per share, which is the market value as of the grant date as determined by our Board of Directors. The option that Dr. Rodman can be exercised in advance. The option will become exercisable in respect of 25% of the shares on the one year anniversary of the fiscal year beginning on July 12, 2022 and

the remaining shares will vest in substantially equal monthly installments for 36 months, subject to Dr. Rodman with us from each acquisition date.

In connection with this offering, our Board of Directors approved the grant of stock options under the 2023 Plan to our executives, effective as of the price date of this offering, as follows: Mr. Congleton, 250,046 options; Doctor Rodman, 104,186 options; and Mr. levy, 97,518 options. These stock options will have an exercise price equal to the initial offering price for this offering and will vest in respect of 25% of the shares on the one year anniversary of the grant date and the remaining shares will vest at substantially the same rate monthly thereafter for 36 months, subject to the continued operation of the Manager with us from every acquisition date. As a condition of receiving the above option awards, Mr. Congleton and Mr. Levy have consented to an amendment to their Restricted Shares dated July 2022 to amend the allocation of such award such that the portion of that award which is due on or before the 10th June 10, 2024 vested on June 10, 2024 and 3/48ºthe shares (or a lesser number of shares available for purchase on an applicable exercise date) subject to such grant will be granted in quarterly installments on July 10, October 10, January 10 and April 10, respectively, until the restriction of such shares is fully invested, subject to the officer's continued service with us from each acquisition date.

Both Restricted Stock Awards that Mr. Levy will vest upon a Change of Control (as defined in the 2020 Plan). Each of the awards presented to our nominee officers is also subject to potential vesting acceleration in connection with a qualifying termination of employment, including in connection with a change of control, as described below in the subsection entitled “Employment Agreements With Our Directors.”

Outstanding stock awards at the end of fiscal year 2022

The following table provides information on the options to purchase outstanding shares and restricted shares held by each of our appointed Executive Officers as of December 31, 2022.

__________________

(1)Market value is calculated by multiplying the number of unrestricted shares outstanding as part of the award by $3.03, which corresponds to the fair market value of our common stock as of November 30, 2022 based on an independent valuation dated November 3, 2022.

(2)On October 9, 2020, our Board of Directors granted Mr. Congleton 463,048 shares that are restricted under our 2020 Plan, with 25% of those shares vested on the first anniversary of the date Mr. Congleton joined us full-time (November 1, 2020) , and the remaining shares will vest in equal monthly installments over the next 36 months, subject to Mr. Congleton as service provider until each date of purchase.

(3)These awards are subject to potential acceleration of vesting in connection with a qualifying termination of employment, including in connection with a change of control, as described below in the subsection entitled “Employment Agreements With Our Executive Directors”. The stock option of Dr. Rodman, granted on March 12, 2021, and Mr. Levies, granted on March 10, 2022 and July 10, 2022, are subject to an accelerated award in connection with a change of control as described in the “Stock-Based Incentive” subsection above.

(4)On March 12, 2021, our Board of Directors granted options to Mr. Congleton and Dr. Rodman pursuant to our 2020 plan to purchase 24,082 shares and 240,827 shares, respectively, with 25% of such shares on the first anniversary of the 1 next 36 months, subject to the continued status of the relevant executive director appointed as service provider up to each vesting date. The Dr. Congleton has a morning exercise function, Mr. Congleton exercises the option while not owned and receives restricted shares of our common stock, which expire until the vesting requirement is met. Our 2020 Plan specifically authorizes this concept of early vesting and specifies that employees who exercise options without exercising will receive restricted shares with a grace period equal to the grace period remaining in the exercised option. Due to this early exercise characteristic, these options are reflected in the “Exercisable” column as of December 31, 2022.

(5)As a condition for receiving the Dr. Congleton and Mr. Levy in connection with this Offering, as described above, each officer has agreed to amend their July 2022 restricted stock award to amend the vesting of such award so that the portion of that award awarded on or before June 2024 would have vested in June October 10, 2024 and 3/48 of the shares (or a lesser number of shares available for purchase as of an applicable exercise date) subject to such award will vest in quarterly installments every 10th of October 2024 July 10, October 10, January 10 and April 10 vest thereafter until such restricted shares vest in full, subject to the executive's continued service with us from each exercise date.

(6)On July 12, 2022, our board of directors appointed Dr. Rodman an option under our 2020 plan to purchase 304,730 shares, with 25% of those shares vesting on the first anniversary of the exercise date on July 12, 2022 and the remaining shares vesting in equal monthly installments for the next 36 months, subject to dr. Rodman as service provider through each date of purchase. This stock option, which Dr. Rodman has a morning exercise function that allows Dr. Rodman will exercise the option pending exercise and receive restricted shares of our common stock, which will expire until the vesting requirement is met. Due to this early exercise characteristic, these options are reflected in the “Exercisable” column as of December 31, 2022.

Employment contracts with our Executive Directors

We have concluded amended employment contracts with each of the gentlemen. Congleton, Dr. Rodmann and Mr. Levy, whose agreements will become effective upon the consummation of this Offer. According to the employment letter, each of Messrs. Congleton, Dr. Rodmann and Mr. Levy are entitled to an annual base salary of $420,000, $414,750 and $415,000, respectively, and an annual bonus of 25%, 25% and 40%, respectively, based on the achievement of performance targets set by our Board of Directors become.

Regardless of how an officer's employment ends, an officer is entitled to receive amounts previously earned during his or her employment, including unpaid salary, reimbursement of expenses owed and time off accrued but unpaid, and any continued benefit payments required by law. In addition, each officer is entitled to certain severance benefits under their employment agreement (as described below), subject to signing a indemnification and fulfilling the post-termination obligations set forth in their proprietary Information and Invention Release Agreement.

Labor letters provide severance benefits for certain terminations that occur during and outside of a change of control period. In the event of wrongful termination or resignation for cause outside of a Change of Control Period (as defined below), each officer will be entitled to (i) his or her base salary for 12 months (for Mr. Congleton) or 9 months (for Dr. Rodman and Mr. Levy ) after the termination date, the amount of which will be paid in a lump sum (for Mr. Levy) or in accordance with our usual payroll practices during the applicable notice period (to Mr. Congleton and Dr. Rodman). , (ii) a fixed cash award equal to the executive's annual target bonus pro rata based on the total number of days elapsed in the calendar year since the executive's termination date, (iii) accelerated allocation of such number of the executive's non-carrying equity awards, that vest based on the passage of time as they would have vested if the Executive had remained with us during the notice period set forth in clause (i) above, and (iv) payments or refunds o COBRA Awards to the Executive and their elected eligible dependents or, if COBRA is not available under our group health insurance plan, a cash amount equal to such payments or reimbursements by (a) the last day of the notice period specified in clause (i) above or (b) the first day) the date, on which the manager is entitled to comparable health insurance coverage under a future employer's group health insurance plan. If terminated without notice or resigning for cause within three months before or 12 months after a change of control (such period being the change of control period), each officer is entitled to (i) his or her base salary for 18 months (for Mr. Congleton ) or 12 months (for both for both Dr. Rodman and Mr. Levy) after the date of termination paid as a lump sum (for Mr. Levy) or in accordance with our payroll standard over the applicable termination period (e.g. Mr. Congleton and Dr. Rodman), (ii) a fixed monetary amount of the executive's annual target bonus (amount equal to 150% of his target annual bonus to Mr. Congleton), (iii) accelerated vesting of all unvested stock stock awards that vest based on the passage of time (provided that stock awards granted to Mr. Congleton and Dr Rodman prior to this Offer, such expedited acquisition only upon termination review occurs within 12 months of a credit modification); and (iv) payers or refunds of COBRA awards for the executive and their eligible dependents, or if COBRA insurance is not available under our group health insurance plan, a cash amount equal to such payments or refunds up to (a) the last day of the notice period referred to in clause (i) above, or (b) the date on which the manager becomes eligible for comparable health insurance coverage under a group health insurance plan of a subsequent employer. Earning of performance stock awards is subject to the applicable grant agreement.

To the extent that payments or benefits received in connection with a change of control are subject to an excise tax under Section 4999 of the Internal Revenue Code, such payments and/or benefits are also subject to an "enhanced salary cap." Reduction if such reduction results in a greater net after-tax benefit to the executive than receiving the full amount of those payments.

Each Executive Director has entered into our standard Disclosure of Proprietary Information and Invention Agreement, which includes a one-year non-solicitation clause upon termination.

For modified employment letters with our senior executives:

“Cause” means (i) the commission of any fraudulent, embezzling or dishonest act or the commission of any other illegal act which has a demonstrable adverse effect on us or any successor or Affiliate; (ii) a conviction or plea of ​​“guilty” or “pled not guilty” to a felony or a felony involving fraud, dishonesty, or moral defamation under the laws of the United States or any other state; (iii) any intentional and unauthorized use or disclosure by the officer of any confidential information or trade secrets of us or any successor or affiliate; (iv) gross negligence, disobedience or material breach of any duty of loyalty to us or any successor or affiliate or any other demonstrable material misconduct on the part of the officer; (v) the officer's continued and repeated failure or refusal to perform or neglect of the officer's duties under his offer letter or continued and repeated failure to comply with or refusal to follow instructions given to him by our board of directors, which does not last the compliance, refusal or negligence 15 days after receipt of written notice from our Board of Directors specifically stating the nature of such default, refusal or negligence; or (vi) willful and material violation of any of our material policies or a material provision of the executive's offer letter or agreement to release proprietary information and inventions.

“Change of Control” has the meaning given to that term in the 2023 Plan.

“reasonable cause” means the following without the written consent of the manager: (i) a material reduction in authority, duty or responsibility; (ii) a material reduction (i.e., a reduction of 10% or more) in base salary or target bonus opportunity, whether such reduction is attributable to a single reduction or a series of reductions in base salary, unless such reduction occurs generally imposed on our senior management; (iii) a material change in the geographic location in which the manager is expected to carry out his or her duties; or (iv) any other act or omission by us or any successor or affiliate that constitutes a material breach of the officer's duties under his letter of employment, provided that in each case an officer has no good cause unless : (a) the Executive gives written notice of the occurrence of any of the foregoing events or conditions without their written consent within 60 days of the occurrence of such event; (b) we or any successor or affiliate fails to cure such condition within 30 days of receipt of written notice of such event from the officer; and (c) the Executive's resignation for such cause shall be effective 30 days after the expiration of our 30-day grace period.

healthcare and pension and retirement provision; privileges

All of our currently appointed officers are eligible to participate in our employee benefit plans, including medical, dental, vision, disability and life insurance plans, in each case in the same way as all of our other employees. We generally do not grant personal privileges or benefits to our appointed officers, except in certain circumstances. Our Board of Directors may decide to introduce qualifying or non-qualifying benefit plans in the future if it determines it is in our best interests to do so.

Plano 401 (k)

Our nominated officers are eligible to participate in a defined contribution pension plan that offers eligible employees the opportunity to save for retirement based on tax benefits. Eligible employees may defer eligible compensation before tax or after tax (Roth) up to the statutory annual contribution limits under the Code. Contributions are allocated to each participant's individual account and then applied to investment alternatives selected according to participants' policies. The 401(k) Plan is intended to qualify under Section 401(a) of the Code, with the trust associated with the 401(k) Plan being intended to be exempt under Section 501(a) of the Code. As a tax-advantaged retirement plan, contributions to the 401(k) plan (excluding Roth contributions) and income from those contributions are not taxable until distributed

of the 401(k) plan. Our Board of Directors may decide to introduce qualifying or non-qualifying benefit plans in the future if they determine it is in our best interests to do so.

Compensation and Change of Control Benefits

Our officers may be entitled to certain benefits or additional benefits upon termination of qualifying employment, including in connection with a change of control, pursuant to their offer letters. In addition, certain stock option agreements with Dr. Rodman and the Restricted Stock Agreements with Mr. Levy anticipates the accelerated acquisition of all outstanding shares following a change of control. See “—Equity Based Incentives” and “—Employment Agreements with our Executive Directors” above for further discussion.

Capital Incentive Plans

The key features of our equity participation plans are summarized below. These summaries are qualified in their entirety by reference to the actual wording of the applicable plan, each of which is or will be filed as an annex to the Registration Statement of which this Prospectus forms a part.

2023 Incentive Rewards Plan

In connection with this offering, our board of directors adopted and our shareholders approved the 2023 Plan, under which we may award cash awards and stock incentives to qualifying service providers to attract, motivate and retain the talent we compete for. The key terms of the 2023 Plan are summarized below. The 2023 Plan is effective the day before the first public trading day of our common stock.

Licensing and Administration.Our employees, consultants and directors and employees and consultants of our subsidiaries are eligible to receive awards under the 2023 Plan. Post our IPO, the 2023 Plan will generally be administered by our Board of Directors in relation to non-director employee awards and by our Compensation Committee in relation to other participants, each of whom delegates their roles and responsibilities to committees of our directors and/or officers may (collectively referred to as the Plan Administrators), subject to certain restrictions imposed by the 2023 Plan, Section 16 of the Stock Exchange Act and/or Stock Exchange Rules, as applicable. The Plan Administrator shall have the authority to make all determinations and interpretations, prescribe all forms for use and issue rules for the administration of the 2023 Plan, subject to its express terms and conditions. The Plan Administrator also determines the terms of all awards in the 2023 Plan, including any vesting conditions and the acceleration of vesting.

Limitation on Available Prizes and Shares.The number of shares initially available for issuance under awards granted under the 2023 Plan is equal to the aggregate of (1) 4,650,000 shares plus (2) all shares outstanding under awards under the 2020 Plan as of the Plan 2023 Effective Date are subject thereafter to be available for issuance under the terms of the 2023 Plan. The number of shares initially available for issuance will be increased on January 1 of each calendar year beginning in 2024 and ending in 2033 by an amount equal to the lesser of (a) 4% of the common shares outstanding on the last day the immediately preceding calendar year and (b) fewer shares as determined by our Board of Directors. No more than 100,000,000 common shares may be issued upon exercise of incentive stock options under the 2023 Plan. Shares issued under the 2023 Plan may be authorized but unissued shares acquired on the open market, or own shares.

If an award under the 2023 Plan or the 2020 Plan expires, lapses or is cancelled, exchanged or settled for cash, redeemed, repurchased, canceled without full exercise or forfeited, in each case in a manner which results in the acquisition of shares of the award covered price at a price no more than the price paid by the participant for those shares, or does not issue any shares covered by the award, all shares subject to such award will become available for further allocations, as the case may be, or are again available under the 2023 Plan. under the 2023 Plan upon acceptance or replacement of awards approved or outstanding under a qualifying stock plan operated by a company with which we are entering into a merger or similar corporate transaction are not reducing the shares available for grant under the 2023 Plan.

Prices.The 2023 Plan provides for the granting of stock options, including incentive stock options or ISOs as defined in Section 422 of the Code, and non-qualifying stock options or NSOs; limited inventory; dividend equivalents; restricted stock units or RSUs; Stock Appreciation Rights or SARs; and other stock or cash prices. Certain awards under the 2023 Plan may constitute or provide for a deferral of compensation, subject to Section 409A of the Code, which may impose additional requirements on the terms of such awards. All awards under the 2023 Plan will be set forth in award agreements, which will set out the terms of the awards, including any applicable vesting and payment terms and post-termination vesting restrictions. Awards other than cash awards are generally settled in shares of our common stock, but the Plan Administrator may arrange for a cash settlement for any award. A brief description of each type of award follows.

•stock options. Stock options provide for the purchase of common stock in the future at an exercise price specified on the grant date. Unlike NSOs, ISOs can grant their holders tax deferral beyond exercise and favorable capital gains tax treatment if certain retention periods and other Code requirements are met. The exercise price of a stock option is not less than 100% of the market value of the underlying stock on the grant date (or 110% in the case of ISOs granted to certain significant shareholders), except with respect to certain options granted in connection with a corporate transaction. The term of a stock option may not exceed ten years (or five years in the case of ISOs granted to certain significant shareholders). Vesting conditions determined by the Plan Administrator may apply to stock options and may include continued service, performance and/or other conditions. In general, ISOs can only be awarded to our employees and, if applicable, employees of our parent or subsidiary companies.

•SARs.SARs entitle their holder, at the time of exercise, to receive from us an amount equal to the appreciation in the value of the shares to which the grant relates between the grant date and the exercise date. The exercise price of a SAR will not be less than 100% of the fair market value of the underlying stock on the grant date (except with respect to certain replacement SARs granted in connection with a corporate transaction), and the term of a SAR cannot be over ten years. Vesting conditions set by the Plan Administrator may apply to SARs and may include continued service, performance and/or other conditions.

•Limited inventory and RSUs. Restricted shares are a nontransferable allocation of shares of our common stock that lapse if and until certain conditions are met, and may be subject to a purchase price. RSUs are contractual promises of future delivery of shares of our common stock that may also remain irrevocable if and until certain conditions are met. Delivery of the shares underlying the RSUs may be deferred pursuant to the terms of the grant or at the participant's election if the Plan Administrator permits such deferral. Conditions applicable to restricted shares and RSUs may be based on continued service, achievement of performance targets and/or other conditions as the Plan Administrator may determine.

•Other stock or cash prices. Other stock or cash awards include cash awards, fully-allocated shares of our common stock, and other awards measured in whole or in part by reference or otherwise to shares of our common stock. Other stock or cash awards may be awarded to participants and may also be available as a payment in the settlement of other awards, as stand-alone payments, and as a payment in lieu of base salary, bonuses, fees, or other cash compensation otherwise payable to an individual who entitled to receive prizes. The Plan Administrator determines the terms of other stock or cash awards, which may include vesting conditions based on continuity of service, performance and/or other conditions.

•Dividend Equivalents. RSUs or other equity and cash-based awards may come with the right to receive the equivalent amount of dividends paid in shares of our common stock prior to delivery of the underlying shares. Such matching dividends will only be paid to the extent that any vesting conditions are subsequently satisfied, unless otherwise determined by the Plan Administrator. No corresponding dividends are paid on stock options or SARs.

performance bonuses.Performance Awards include any of the foregoing awards, which are subject to vesting and/or payment based on the achievement of specified performance targets or other criteria that the Plan Administrator may determine which may be objectively determinable. The performance criteria, on the basis of which performance targets are determined by the Plan Administrator, may include: net gains or losses (before or after one or more interest, taxes, depreciation, amortization and non-cash stock-based compensation); gross or net sales or revenue or sales or revenue growth; net income (before or after taxes) or adjusted net income; profits (including but not limited to gross profits, net profits, profit growth, net operating profits or economic profits), earnings yield ratios or operating margin; budget or operating profits (either before or after taxes or before or after allocation of overheads and bonuses); cash flow (including operating cash flow and free cash flow or cash flow return on equity); return on investment; return on capital or invested capital; capital costs; return on equity; total shareholder return; sales results; costs, cost reductions and cost control measures; Costs; working capital; earnings or loss per share; adjusted earnings or loss per share; price per share or dividends per share (or increasing or maintaining such price or dividends); regulatory or compliance services; Implementation, completion or achievement of goals related to research, development, regulatory, commercial or strategic milestones or developments; market share; models of economic value or economic added value; financial goals of the division, group or company; customer satisfaction/growth; Customer service; employee satisfaction; recruitment and maintenance of personnel; human capital management (including diversity and inclusion); monitoring litigation and other legal matters; strategic partnerships and transactions; financial metrics (including those measuring liquidity, activity, profitability or leverage); debt level or reduction; sales-related goals; financing and other fundraising operations; Cash on hand; procurement activity; Investment sourcing activities; and marketing initiatives, each of which can be measured in absolute terms or against an incremental increase or decrease. Such performance targets may also be based solely on our performance or the performance of a subsidiary, division, business segment or business unit, or based on performance in comparison to the performance of other companies, or on comparisons of relevant performance data of indicators to the performance of other companies.

Director's Salary.The 2023 Plan provides that the Plan Administrator may from time to time determine compensation for non-employee directors, subject to the restrictions of the 2023 Plan. In connection with this offering, our shareholders have approved the original terms of our non-employee director compensation program, which are set out below as described under the heading "Compensation of the members of the Management Board". Our Board of Directors or its authorized committee may, from time to time, in the exercise of its business judgment, amend the non-employee director compensation program taking into account factors, circumstances and considerations that it deems relevant from time to time, provided that the total of cash or other consideration and the fair value (as determined in accordance with FASB ASC 718 or any successor thereof) at the grant date of stock awards made as compensation for non-employee director services during a calendar year may not exceed $750,000, increased to $1,500,000 in the calendar year in which a Non-Employee Director serves as a Non-Employee Director or in which a Non-Employee Director serves as Chairman of our Board of Directors or Principal Independent Director (where the limits do not apply for the remuneration of ni Any non-employee director acting in any capacity any role other than that of a non-employee director for which he or she receives additional personal remuneration or remuneration paid to a non-employee director prior to the calendar year following the calendar year , in which this offer takes place). The Plan Administrator may, in exceptional circumstances, make exceptions to this limit for individual non-employee directors, as determined by the Plan Administrator in its sole discretion, provided that the non-employee director receiving such additional compensation is not involved in the decision to award such additional compensation compensation or in other contemporary compensation decisions involving non-employee directors.

Certain Transactions.In connection with certain transactions and events affecting our common stock, including a change of control (as defined below) or a change in applicable law or accounting standard, the Plan Administrator has broad powers to take action under the 2023 Plan to add dilution or appreciation prevent intended benefits, facilitate such a transaction or event, or implement any such change in applicable law or accounting standard. This includes the forfeiture of prizes in exchange for a sum of money or other property of a value equal to the value obtained upon the exercise or liquidation of the vested portion of such prize or the realization of Entrant's rights under the vested portion of such prize would be awards, accelerating the vesting of awards, acquiring or replacing awards with a successor entity, adjusting the number and type of shares available, replacing awards with other rights or ownership, or terminating awards under the 2023 Plan.

Change of Control If the acquirer does not assume awards granted under the 2023 Plan, awards issued under the 2023 Plan will be subject to accelerated vesting such that 100% of the awards will vest and be vested or payable. In addition, in the event of certain non-reciprocal transactions with our shareholders (an equity restructuring), the Plan Administrator will make appropriate adjustments to the 2023 Plan and outstanding awards as it deems appropriate to reflect the equity restructuring.

For purposes of the 2023 Plan, a “change of control” means and includes the following:

•a transaction or series of transactions involving a related “person” or “group” of “persons” (as such terms are used in Sections 13(d) and 14(d)(2) of the Stock Exchange Act) (except our or our affiliates, or an employee benefit plan maintained by us, or any of our affiliates, or any "person" who directly or indirectly controls, is controlled by, or is under common control with us prior to any such transaction) directly or indirectly acquires property (in within the meaning of Rule 13d-3 of the Stock Exchange Act) in our securities by immediately after such acquisition holding more than 50% of the total combined voting rights of our outstanding securities; or

•during any two consecutive year period, persons who form our Board of Directors at the beginning of that period, together with any new directors (other than a director who has been appointed by a person who has entered into an agreement with us to effect a change in the Controlling Transaction) whose election by our Board of Directors or nomination for election by our shareholders by a majority vote of at least two-thirds of the incumbent Directors who were Directors at the beginning of the biennium, confirmed or elected or nominated for election election was previously authorized without a majority for any reason; or

•the consummation (directly or indirectly) of (x) any merger, consolidation, reorganization or business combination by us, or (y) any sale or other disposal of all or substantially all of our assets in a single transaction or series of related transactions, or (e.g ) the acquisition of assets or shares of another entity, each with the exception of one transaction:

•that results in our voting securities outstanding immediately prior to the transaction either remaining outstanding or converted into voting securities of the company or person that directly or indirectly controls the company as a result of the transaction, directly or indirectly all or substantially all of our assets or are otherwise successful, directly or indirectly, in our business, at least a majority of the combined voting rights of the assignee's outstanding voting securities immediately after the transaction; And

•no person or group owns voting securities representing 50% or more of the combined voting rights of the successor entity; provided, however, that no person or group will be treated as having 50% or more of the combined voting rights of the successor company solely by virtue of the voting rights held by our company prior to the consummation of the transaction.

Foreign Entrants, Refund Policy, Transferability and Entrant Payments.With respect to overseas participants, the Plan Administrator may change the grant terms, establish sub-plans and/or adjust other grant terms, subject to the quota limits described above. All prizes are subject to the terms of any refund policy implemented by our company and to the extent set out in that refund policy or the applicable prize agreement. With limited exceptions for estate planning, domestic relationship arrangements, certain nominations of beneficiaries, and rights of descent and distribution, pre-vesting 2023 Plan awards are generally non-transferable and exercisable only by the participant. With respect to withholding tax obligations arising from awards under the 2023 Plan and exercise price obligations arising from the exercise of stock options or SARs under the 2023 Plan, the Plan Administrator may, at its sole discretion, redeem shares in cash, by wire, or by check accept our common stock that satisfies certain conditions (a market sell order), or any other consideration you deem appropriate, or a combination of the foregoing.

Modification and Termination of the Plan.Our Board of Directors may amend, suspend or terminate the 2023 Plan at any time; However, except for certain changes in our capital structure, shareholder approval is required

required for any amendment that increases the number of shares available in the 2023 Plan The Plan Administrator has the authority, without the approval of our shareholders, to amend outstanding stock options or SARs to reduce their exercise price per share. Awards under the 2023 Plan may no longer be awarded after the tenth anniversary of the date our Board of Directors approved the 2023 Plan.

Kapitalanreizplan 2020

On July 7, 2020, our Board of Directors and shareholders approved adoption of the 2020 Capital Incentive Plan, as amended and updated effective June 1, 2022.

As of December 31, 2022, a total of 3,445,626 common shares were reserved for issuance under the 2020 Plan. As of December 31, 2022, 1,199,135 shares of our common stock were subject to the grant of outstanding restricted shares under the 2020 Plan, 1,365,442 options were granted to purchase our common stock under the 2020 Plan, and 291,432 shares of our common stock remained for future issuance under the 2020 Plan accessible.

No additional awards will be awarded under the 2020 Plan after the Effective Date of the 2023 Plan, however, the 2020 Plan will continue to govern the terms of any outstanding awards awarded under the Plan. Shares of our common stock that are subject to awards granted under the 2020 Plan and that expire, expire, or are cancelled, exchanged for cash, redeemed, repurchased, or forfeited after the effective date of the 2020 Plan are eligible for issuance under the 2023 Plan Agree with your terms and conditions.

Administration.Our Board of Directors administers the 2020 Plan, unless they delegate authority to administer the Plan. Subject to the terms and conditions of the 2020 Plan, the Trustee shall have the power to select the individuals to be awarded the awards, to determine the type or types of awards to be awarded to each person and to determine the number of awards to be awarded to determine the number of shares, subject to such awards and to determine the terms of such awards and to make all other determinations and decisions and take all other actions necessary or advisable for the administration of the 2020 Plan, subject to certain limitations of the Rules related to the administration of the 2020 Plan set up, accept, change or revise.

Authorization.The awards of the 2020 Plan may be made to individuals who are our employees, consultants and members of our Board of Directors and our subsidiaries. Only employees can receive ISOs.

Prices.The 2020 Plan provides that our trustee may grant or issue stock options (including NSOs and ISOs), restricted stock, RSUs, other stock-based awards, or a combination thereof. Each award will be set forth in a separate agreement with the individual receiving the award, specifying the nature, terms and conditions of the award.

Certain Transactions.The Plan Administrator has broad discretion to make appropriate adjustments to the terms of the 2020 Plan and the terms of any existing and future awards, including with respect to the total number and type of shares subject to the 2020 Plan and awards granted under the 2020 Plan, to avoid dilution or magnification of intended benefits and/or to facilitate necessary or desirable changes in certain transactions and events affecting our common stock, such as B. Stock dividends, stock splits, mergers, acquisitions, consolidations and other corporate transactions. The Plan Administrator may also cause awards to be accelerated, withdrawn, terminated, assumed, substituted or converted in the event of a change of control or other unusual or one-off event or transaction. In addition, in the event of certain non-reciprocal transactions with our shareholders or an "equity reorganization," the Plan Administrator will make appropriate adjustments to the 2020 Plan and outstanding awards as it deems appropriate to reflect the equity reorganization.

In the event of a change of control in which awards granted under the 2020 Plan are discontinued, converted, assumed or replaced, the Plan Administrator may elect that awards granted under the 2020 Plan to individuals who did not experience termination of service will be subject to the Provisions are for accelerated vesting so that 100% of the awards vest and become exercisable or payable immediately prior to the change of control. For purposes of the 2020 Plan, a change of control is generally defined as: (1) a merger or consolidation of our business with or into another company, entity or person; (2) a sale, lease, barter or other transfer in one transaction or series of related transactions all or substantially all of our business assets; or (3) any other transaction, including a sale by us of new shares of our common stock or a transfer of existing shares of our common stock

As a result, immediately prior to any such transaction, a third party unaffiliated with us or our shareholders (or a group of third parties unaffiliated with us or our shareholders) will acquire or hold share capital representing a majority of our outstanding voting capital immediately after such transaction; provided that the following events do not constitute a “change of control” under the 2020 Plan: (a) a transaction (other than the sale of all or substantially all of our assets) in which the holders of our securities immediately prior to the amalgamation or amalgamation immediately after the amalgamation or amalgamation directly or indirectly hold at least the majority of the voting shares in the successor company or its parent company; (b) a sale, lease, barter or other transaction in a transaction or series of related transactions of all or substantially all of our assets to an affiliate of ours; (c) an initial public offering of any of our securities or other transaction primarily for the purpose of bona fide equity financing; (d) a new incorporation solely to change our jurisdiction; or (e) a transaction entered into for the primary purpose of forming a holding company that will be owned in substantially equal proportion by the persons who held our securities immediately prior to such transaction.

Modification and Termination of the Plan. Our Board of Directors may terminate, suspend or amend the 2020 Plan; provided that no change to the 2020 Plan could adversely affect any Award outstanding at the time of the change without the consent of the Awardee. However, any amendment to the 2020 Plan will require shareholder approval to the extent necessary and desirable to comply with any applicable law, regulation or stock exchange rule.

Employee share purchase plan 2023

In connection with this offering, our Board of Directors has approved the ESPP and our shareholders have approved it. The key terms of the ESPP are summarized below. The ESPP becomes effective the day before the first public trading day of our common stock.

The ESPP consists of two distinct components to provide more flexibility in granting stock options under the ESPP to US and non-US employees. Specifically, the ESPP authorizes (1) the granting of options to US employees intended to qualify for favorable US federal tax treatment under Section 423 of the Code (part of Section 423) and (2) the granting of options that it does not intend are eligible to tax under Section 423 of the Code to facilitate the participation of non-US employees who do not benefit from favorable US federal tax treatment and to provide flexibility to comply with non-US laws and other considerations (non-US Section 423 component). Where permitted by local law and custom, we expect that the non-Section 423 component will generally operate and be managed on terms similar to those of the Section 423 component.

Shares Available for Allocation; Administration.A total of 400,000 of our common shares will initially be reserved for issuance under the ESPP. In addition, the number of Shares available for issuance under the ESPP will increase annually on January 1 of each calendar year beginning in 2024 and ending in 2033 by an amount equal to the lesser of (A) 1% of the shares outstanding as of the last day of the immediately preceding calendar year and (B) such smaller number of shares as may be determined by our Board of Directors provided that no more than 15,000,000 of our common shares are outstanding under the ESPP ( may be issued in whole or in part) which may be issued under component of section 423). Our Board of Directors, or a committee of our Board of Directors, manages and has the authority to interpret the terms of the ESPP and to determine the eligibility of participants. We believe that the Compensation Committee is the original administrator of the ESPP (hereinafter referred to as the Plan Administrator).

Authorization. We expect all of our employees to be eligible to participate in the ESPP. However, an employee may not receive stock rights under the ESPP if, immediately after the grant, the employee owns (directly or by attribution) stock representing 5% or more of the total voting rights or value of all grades of our stock.

Grant of Rights.Shares will be offered during the offering periods under the ESPP. The duration of the offer periods under the ESPP is determined by the Plan Administrator and can be up to twenty-seven months. Employee payroll deductions are used to purchase stock on each purchase date during an offering period. Offer Days for each Offer Period are the Last Dealing Day in the Offer Period. Offer periods in

ESPP begins when determined by the plan administrator. The Plan Administrator, in its sole discretion, may change the terms of any future offer period. In jurisdictions outside the United States where participation in the ESPP through deductions from salary is prohibited, the Plan Administrator may determine that an Eligible Employee may qualify for participation by making contributions to the participant's ESPP account in a manner acceptable to the Plan Administrator in lieu of or in addition to wage deductions.

The ESPP allows participants to purchase common stock through payroll deductions up to a percentage of their eligible compensation. The Plan Administrator will determine a maximum number of Shares that a Participant may purchase during any Offering Period. In addition, no employee may acquire the right to purchase stock under Component of Section 423 at a price in excess of $25,000 in any calendar year in which such right to purchase is outstanding (based on the market price at fair value). ). for ordinary shares from the first day of the offer period).

On the first trading day of each offering period, each participant will automatically receive an option to purchase our common shares. The option will expire at the end of the applicable offering period and will be exercised at that time up to the limit of salary deductions accrued during the offering period. Unless otherwise stated, the purchase price for the shares is 85% of the lower of the fair value of our common shares on the first trading day of the offer period or on the date of acquisition. Participants may voluntarily terminate their participation in the ESPP at any time during a specified period prior to the end of the applicable offering period and will receive their accrued deductions from salaries that have not yet been used to purchase common stock. Participation ends automatically with the termination of a participant's employment.

A participant may not transfer the rights granted by the ESPP other than by will or under the law of descent and distribution, and such rights are generally exercisable only by the participant.

Certain Transactions. In the event of certain non-reciprocal transactions or events affecting our common stock, the plan administrator will make appropriate adjustments to the ESPP and outstanding claims. In the event of certain unusual or one-off events or transactions, including a change of control, the Plan Administrator may cause (1) to replace pending rights with other rights or property, or to terminate pending rights for cash, (2) to obtain or replace any outstanding rights with the successor or the surviving company or parent or subsidiary, if any, (3) the adjustment of the number and type of shares subject to outstanding rights, (4) the use of accrued salary deductions from participant shares on a new purchase date prior to the next scheduled one purchase date and terminate all rights during current offer periods or (5) terminate all outstanding rights.

change of plan.The Plan Admin may change, suspend or terminate the ESPP at any time. However, shareholder approval will be obtained for any changes that increase the total number or change the type of shares that may be sold under the ESPP rights, or change the companies or classes of companies whose employees are eligible to participate in the ESPP.

Compensation for non-employee directors

We have not granted any cash, equity or other compensation to our non-employee directors for the year ended 31 December 2022. We have a policy to reimburse all of our non-employee directors for their reasonable out-of-pocket expenses in connection with attending board meetings of management and committees.

Post-IPO Directors' Compensation Scheme

In connection with this offering, our Board of Directors and our shareholders approved the original terms of our non-employee director compensation program. The relevant terms of the Non-Employee Director's Compensation Scheme are summarized below.

The Non-Employee Director Compensation Program provides our non-employee directors with annual holding fees and/or long-term stock awards. We expect each non-employee director to receive an annual advance of $40,000. A non-employee director serving as chairman or senior independent director will receive an additional annual fee of US$30,000. Non-Employee Directors Acting as Audit Chairs Remuneration

and the nominating and corporate governance committees receive additional annual compensation of $15,000, $10,000 and $8,000, respectively. Non-employee directors who serve as members of the Audit, Compensation and Nominating and Corporate Governance Committees receive additional annual withholding taxes of $7,500, $5,000 and $4,000, respectively. Each non-employee director serving on the Board at the time of this offering and each non-employee director first appointed or elected to the Board after the date of this offering will receive an initial grant of options to purchase 44,000 common shares representing the monthly over a period of three years. Non-employee directors will also receive annual grants of options to purchase 22,000 common shares on the date of each annual meeting of our stockholders subsequent to the closing of this offering, purchasing in substantially equal monthly installments for the 12 months following the grant date (or, if the next annual meeting of our stockholders prior to the first anniversary of the grant date, any remaining unvested portion of the annual award will vest on the date of that annual meeting of our shareholders). All options granted to our non-employee directors will have an exercise price equal to the fair market value of our common stock at the grant date (as defined in the 2023 Plan), which for the options to be granted in connection with this offering will be the IPO price in this be offer. Awards for our non-employee directors also vest upon termination of service due to death or disability and in the event of a change of control (as defined in the 2023 Plan).

Compensation for our non-employee director compensation program is subject to the annual non-employee director compensation caps set forth in the 2023 Plan, as described above. Our Board of Directors or its authorized committee may amend the Non-Employee Director Compensation Program from time to time in the exercise of its business judgment taking into account such factors, circumstances and considerations as it deems relevant from time to time, subject to those set out in the 2023 Plan established annual cap on the remuneration of non-employee directors (these limits do not apply to non-employee directors who serve in an additional capacity in the company for which he or she receives remuneration or remuneration paid to another) employee Director prior to the calendar year following the calendar year in which this offering occurs). As contemplated by the 2023 Plan, our Board of Directors or its authorized committee may, in exceptional circumstances, make exceptions to this limit for non-employee individual directors, as the Board of Directors or its authorized committee may determine in its sole discretion, provided that this is not the The case is - employed directors who receive such additional compensation shall not participate in the decision to award such compensation or in any other compensation decision involving non-employed directors.

CERTAIN RELATED PARTY RELATIONSHIPS AND TRANSACTIONS

The following is a summary of transactions since inception in May 2019 in which we are involved where the amount involved has exceeded or will exceed the lesser of $120,000 and one percent of the average of our total assets as of December 31. 2020 and 2021, and in which any of our directors, officers or, to the best of our knowledge, beneficial owners of more than 5% of our share capital or a member of the immediate family of any of the above has had or will have a direct material or indirect interest, except capital and other awards, terminations, changes of control and other arrangements described in the “Remuneration of Officers and Directors” section. We also describe below certain other transactions with our directors, officers and shareholders.

Convertible Notes

Between May 2019 and July 2020 we raised a total of approx$4.0 millionin convertible bonds to Catalys Pacific Fund, LP (Catalys Pacific), a beneficial owner of more than 5% of our share capital. The Notes bear interest at 6% per annum. The convertible debentures were automatically converted into 10,868,432 shares of our Series A Preferred Stock in February 2021 as part of the Series A Preferred Stock Financing described below.

Preferred Stock Financing

Funding of Series A Convertible Preferred Stock.In February 2021, we entered into an agreement to purchase Series A Preferred Stock, as amended April 2021, pursuant to which we will sell to investors at initial closing in February 2021 and subsequent closings in April 2021 and January 2021. 2022 in private placements a total of 86,332,216 Series A Convertible Preferred Stock, including the conversion of the convertible debentures described above. The purchase price per share was $0.477 and we received gross proceeds of approximately $40.0 million which included the conversion of the convertible debentures described above at a reduced price of $0.3816 per share.

Funding of Series B Convertible Preferred Stock.In June 2022, we entered into a Series B Preferred Stock Purchase Agreement pursuant to which we sold a total of 136,510,868 convertible Series B Preferred Stock to investors in June 2022 in private placements. Purchase per share was $0.8644 and we received gross proceeds of approximately $118.0 million.

The table below shows the total number of shares purchased by directors, officers or holders of more than 5% of our share capital or their affiliates. Each outstanding share of Convertible Preferred Stock, including the shares identified in the table below, will convert into common stock on a one-for-one basis.10.798immediately before this offer expires.

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(1)Further details of these shareholders and their ownership interests are set out under “Significant Shareholders”.

(2)Represents securities issued by RA Capital Healthcare Fund, L.P. were purchased and RA Capital Nexus Fund III, L.P.

(3)Vertreter der Namensgeber von Adams Street 2016 Direct Venture/Growth Fund LP, Adams Street 2017 Direct Venture/Growth Fund LP, Adams Street 2018 Direct Venture/Growth Fund LP, Adams Street 2019 Direct Venture/Growth Fund LP, Adams Street 2020 Direct Venture/ Growth Fund LP, Adams Street 2021 Direct Venture/Growth Fund LP und Adams Street Growth Equity Fund VII LP.

Participation rights in the public offering

In June 2022, we entered into charter agreements with Catalys Pacific, Samsara BioCapital, L.P., HBM Healthcare Investments (Cayman) Ltd., BioDiscovery 6 FPCI, affiliates of RA Capital Management, L.P. and affiliates of Adams Street Partners, LLC, each holding more than 5% of our common stock. The Letter Agreements grant each such investor an interest right to purchase a specified percentage of common shares in this offering at the offering price, subject to compliance with applicable securities laws. The Consent also provides that in certain circumstances, if an investor is unable to participate in this offering, we will be required to offer shares of our common stock to those investors in a separate private placement concurrent with this offering.

Investor Rights Agreement

We entered into an Investor Rights Agreement, as amended and restated in June 2022 (the Investor Rights Agreement), in February 2021 with holders of our convertible preferred stock and certain holders of our common stock, including holders of more than 5% of our common stock, with the above capital and companies, with which some of our directors are associated. This Agreement provides certain rights relating to the registration of your common stock issued upon the conversion of your convertible preferred stock and certain additional covenants we have entered into. Except for registration rights (including related provisions, under which we agree to indemnify the parties to the Investor Rights Agreement), all rights under this Agreement will terminate upon the closing of this Offering. Registration rights remain after this offer and expire five years after the end of this offer. Please refer to the “Description of Share Capital – Registration Rights” section for more information on these registration rights.

voting agreement

We entered into a voting rights agreement, as amended and restated in June 2022 (the Voting Rights Agreement) above, and companies, with to which some of our Directors are affiliated, pursuant to which the following Directors have been elected and continue to serve as members of our Board of Directors as at the date of this Prospectus: Srinivas Akkaraju , MD , Ph.D., Alexander Asam, Ph.D., Jon Congleton , Derek DiRocco, Ph.D., Olivier Litzka, Ph.D., Brian Taylor Slingsby, MD, Ph.D., MPH, and Takeshi Takahashi, MBA Pursuant to the voting rights agreement, Mr. Congleton, as our Chief Executive Officer, serves on our Board of Directors as Chief Executive Officer. Mr. Takahashi was originally appointed as a representative of our common stockholders, Dr. Akkaraju, Dr. Asam and Dr. Slingsby were originally appointed as agents for the holders of our Series A Convertible Preferred Stock and Dr. Dirocco and Dr. Litzka and were originally elected to our Board of Directors as representatives of the holders of our Series B Convertible Preferred Stock.

The voting agreement will expire upon the closing of this Offering and members previously elected to our Board pursuant to this agreement will continue to serve as directors until they resign, are removed or their successors are duly elected by the holders of our common shares. The composition of our Board of Directors following this Offer is more fully described in the Management - Board Composition and Board Election section.

Right of Refusal and Cosale Agreement

We entered into a first refusal and buy-along agreement in February 2021, as amended and restated in June 2022 (the ROFR Agreement) with holders of our common stock affiliated with our officers and Catalys Pacific, whose companies are referred to in ROFR as Key holders and certain other holders of convertible preferred stock, including holders of more than 5% of our share capital listed above. Pursuant to the ROFR Agreement, we have first refusal rights to certain transfers of our stock by principal holders, holders of our convertible preferred stock have a secondary right of first refusal to such transfers, and such convertible preferred stock holders have call-along rights with respect to transfers. The ROFR agreement ends upon the completion of this offer.

Capital grants for executives and directors

We grant stock options and restricted stock awards to certain of our officers and non-employee directors, as more fully described in the “Remuneration of Officers and Directors” section.

working conditions

We conclude employment contracts with our managerial employees. For more information on these letters of agreement with our officers, see the section entitled “Officers' and Directors' Compensation - Employment Agreements With Our Officers”.

Director's and Director's Remuneration

We have indemnification agreements in place with each of our directors and officers. These agreements require or will require, among other things, that we indemnify each director (and in certain cases their respective venture capital funds) and officers to the maximum extent permitted by Delaware law, including reimbursement of expenses such as attorneys' fees, judgments, fines and settlement amounts arising out of the director or officer in any claim or proceeding, including any claim or proceeding brought by us or under our law, arising out of the person's service as a director or officer.

Our amended and restated Memorandum of Association and Articles of Association provide that we indemnify each of our directors and officers to the maximum extent permitted by Delaware General Corporate Law. In addition, we have purchased directors' and officers' liability insurance, which protects our directors and officers from the costs of defense, settlement or the payment of a judgment in certain circumstances. See “Officials and Directors Compensation – Restrictions and Compensation Issues” for more information.

Policies and Procedures for Transactions with Connected Persons

Our Board of Directors will adopt a written Related Person Transactions Policy, effective upon the closing of this Offering, which will establish the policies and procedures for the review and approval or confirmation of Related Person Transactions. This Policy covers, with certain exceptions set forth in Section 404 of Regulation S-K of the Securities Act, any transaction, arrangement or relationship, or any series of similar transactions, arrangement or relationship, to which we have been or will be a party where the the amount in question exceeds $120,000 or one percent of the average of our total year-end assets for the last two full fiscal years and a related party had or will have a material direct or indirect interest, including but not limited to the purchase of goods or services from or from related persons or organizations in which the related person has a significant interest, indebtedness, debt guarantees and employment of a related person by us. In considering and approving such transactions, our Audit Committee is tasked with considering all relevant facts and circumstances, including but not limited to whether the transaction is on terms comparable to those obtained in a transaction under normal circumstances could increase the interest of the loved one in the operation. All transactions described in this section occurred prior to the adoption of this policy.

MAJOR SHAREHOLDERS

The following table provides information regarding the effective ownership of our common stock as of November 30, 2022, and adjusted to reflect the sale of common stock in connection with this offering, by:

•our appointed officers;

•each of our directors;

•all of our officers and directors as a group; And

•any individual or group of related individuals known to us who beneficially owns more than 5% of our common stock.

The number of participating shares held by each shareholder is determined by rules issued by the SEC. Under these rules, beneficial ownership includes any interest over which a person has sole or joint voting rights or investment power. The applicable percentage ownership is based on 27,056,653 shares of common stock outstanding as of November 30, 2022, effective the automatic conversion of all outstanding shares of our convertible preferred stock into 20,637,415 common shares immediately prior to the closing of this offering, and includes 1,189,488 shares of forfeiture or repurchase rights reserved. In calculating the number of beneficial shares held by an individual and the percentage owned by that individual, common stock subject to options or other rights held by that individual and currently exercisable or becoming exercisable or otherwise within 60 days of November 30th 2022 are deemed to be outstanding, although such shares are not deemed to be outstanding for purposes of calculating percentage ownership by other persons.The table below excludes all potential purchases in this offering by the beneficial owners identified in the table below.

Unless otherwise noted, the address of all beneficiaries listed below is c/o Mineralys Therapeutics, Inc., 150 N. Radnor Chester Road, Suite F200, Radnor, Pennsylvania 19087. We believe, based on the information provided to us, that each The Shareholders listed below have exclusive voting and investment powers in relation to the Shares held by the Shareholder, unless otherwise specified, subject to community property laws, where applicable.

__________________

*Less than 1%.

(1)The General Partner of Catalys Pacific Fund, LP is Catalys Pacific Fund GP, LP. Brian Taylor Slingsby is a Managing Member of Catalys Pacific, LLC, General Partner's General Partner. Catalys Pacific Fund GP, LP and Brian Taylor Slingsby are believed to have voting and investment powers over the shares registered by Catalys Pacific Fund, LP. Catalys Pacific Fund GP, LP and Brian Taylor Slingsby disclaim beneficial ownership of these shares except to the extent of a financial interest therein. The address of the entity listed above is PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands.

(2)Samsara BioCapital GP, LLC (Samsara LLC) is the general partner of Samsara BioCapital, L.P. (Samsara LP) and may be considered the beneficial owner of the shares held by Samsara LP. The doctor. Akkaraju has voting and investment power over the shares held by Samsara LP and can therefore be considered the beneficial owner of the shares held by Samsara LP. Samsara LLC and Dr. Akkaraju waives actual ownership of those shares except to the extent of their respective financial interests therein.

(3)Voting and investment rights over HBM Healthcare Investments (Cayman) Ltd. (HBM Healthcare) is exercised by the Board of Directors of HBM Healthcare. The Board of Directors of HBM Healthcare Investments (Cayman) Ltd. consists of Jean Marc Lesieur, Sophia Harris, Richard Coles, Dr. Andreas Wicki, Paul Woodhouse and Dr. Mark Kronenfeld, neither of whom has individual voting or investment powers in relation to the shares.

(4)Includes 182,538 common shares owned by Adams Street 2016 Direct Venture/Growth Fund LP, 236,138 common shares owned by Adams Street 2017 Direct Venture/Growth Fund LP, 352,646 common shares owned by Adams Street 2018 Direct Venture/Growth Fund LP, 198,101 common shares owned Adams Street 2019 Direct Venture/Growth Fund LP, 211,244 common shares owned by Adams Street 2020 Direct Venture/Growth Fund LP, 204,934 common shares owned by Adams Street 2021 Direct Venture/Growth Fund LP and 877,650 common shares owned by Adams Street Growth Equity Fund VII LP are held. Thomas S. Bremner, Jeffrey T. Diehl, Elisha P. Gould III, Robin P. Murray, and Fred Wang, each of whom is a partner in Adams Street Partners, LLC (or an affiliate thereof), may be considered shareholders with voting and investment rights about stocks. Adams Street Partners, LLC and Thomas Bremner, Jeffrey Diehl, Elisha P. Gould III, Robin Murray and Fred Wang disclaim beneficial ownership of the shares except to the extent of their financial interest therein. The address of Adams Street Partners, LLC is One North Wacker Drive, Suite 2700, Chicago, Illinois 60606.

(5)BioDiscovery 6 FPCI is administered by its management company, Andera Partners. The managing partners of Andera Partners are Raphaël Wisniewski and Laurent Tourtois, neither of whom have individual voting or investment powers in relation to the shares.

(6)Includes 192,847 common shares owned by RA Capital Healthcare Fund, L.P. (RA Healthcare) and 1,735,629 common shares held by RA Capital Nexus Fund III, L.P. (Nexus II). RA Capital Management, L.P. is the investment manager for RA Healthcare and Nexus II. General Partner of RA Capital Management L.P. is RA Capital Management GP, LLC, from which Peter Kolchinsky, Ph.D. and Rajeev Shah are the executive directors. RA Capital Management, LP, RA Capital Management GP, LLC, Peter Kolchinsky, Ph.D. and Rajeev Shah are believed to have voting and investment powers over the shares registered by RA Healthcare and Nexus II. RA Capital Management, LP, RA Capital Management GP, LLC, Peter Kolchinsky, Ph.D. and Rajeev Shah deny actual ownership of those shares except to the extent that they have a financial interest therein. The address of the companies listed above is 200 Berkeley Street, 18th Floor, Boston, Massachusetts 02116.

(7)Includes 787,500 shares repurchaseable by us within 60 days of November 30, 2022 and 11,037 common shares issuable upon exercise of options within 60 days of November 30, 2022.

(8)Includes 120,413 common shares issued upon exercise of options within 60 days of November 30, 2022.

(9)Alexander Asam is an investment advisor at HBM Partners AG. HBM Partners AG acts as investment advisor to HBM Healthcare Investments (Cayman) Ltd. The doctor. Asam has no voting or investment power over HBM Healthcare Investments (Cayman) Ltd. shares held. for HBM Partners Ltd. HBM Partners AG acts as investment advisor to HBM Healthcare Investments (Cayman) Ltd. The doctor. Asam has no voting or investment power over HBM Healthcare Investments (Cayman) Ltd. shares held. and disclaims actual ownership of such shares.

(10)Includes the measures described in notes 7 and 8 above. It also includes 344,561 common shares owned by Adam Levy, our Chief Financial Officer, Chief Business Officer and Secretary, all of which are redeemable within 60 days of November 30, 2022.

DESCRIPTION OF SHARE CAPITAL

General

The following description summarizes some of the terms of our amended and updated Memorandum of Association and Articles of Association effective upon the closing of this Offering, our Investor Rights Agreement and the Delaware General Corporation Law. As this is a summary only, it does not contain all the information that may be important to you. A full description is contained in our Amended and Restated Memorandum of Association, Amended and Restated Articles of Incorporation and Investor Rights Agreement, copies of which are attached to the Registration Statement, of which this Prospectus forms an integral part.

Upon the closing of this offering, our authorized share capital will be 500,000,000 common shares with a par value of $0.0001 per share and 50,000,000 preferred shares with a par value of $0.0001 per share.

Common stock

As of September 30, 2022, 27,056,653 common shares were outstanding and registered by 35 shareholders, including 1,228,075 blocked common shares subject to expiry or our right of repurchase after all outstanding shares of our preferred stock, which are convertible into 20,637,415, were automatically converted Common Shares, which will occur automatically immediately prior to the closing of this Offering. Based on the number of common shares outstanding as of September 30, 2022, and assuming we issue an additional 10,000,000 common shares in this offering, there will be 37,056,653 common shares outstanding at the end of this offering. Holders of our common stock are entitled to one vote for each share held on all matters subject to a shareholder vote, including the election of directors, and are not entitled to cumulative voting rights. Accordingly, holders of a majority of the outstanding common shares entitled to vote in an election of directors may elect any director who is a candidate for election if they so choose, except for directors who are holders of preferred stock which we may issue entitled to vote . Subject to an absolute majority of votes for some matters, other matters will be decided by the affirmative vote of our stockholders with a majority of the stockholders present or represented voting on that matter. Our amended and updated Memorandum of Association and Articles of Association also provide that our directors may be removed only for cause and only by the consent of holders of at least two-thirds of the voting rights of the outstanding shares in the stock capital entitled to vote for him . In addition, the consent of holders of at least two-thirds of the voting rights of the outstanding shares of the voting share capital is required to vary or revoke several of the provisions of our Amended Certificate or to adopt any provision that is inconsistent with our Incorporation and Consolidation. See “—Anti-Takeover Effects of Delaware Law and Our Memorandum and Bylaws—Amendment of Articles of Incorporation” below.

Subject to any preference that may apply to preferred stock then outstanding, holders of common stock will be entitled to receive pro rata dividends, if any, as declared by the Board of Directors, from funds available at law. In the event of our liquidation, dissolution or liquidation, the holders of common stock will be entitled to a proportionate interest in any assets lawfully available for distribution to shareholders upon payment or discharge of all of our debts and other liabilities, subject to the foregoing rights of any action preferably then in circulation. Holders of common stock have no right of first refusal, conversion or other subscription right, and there are no redemption or redemption provisions for common stock. All of the outstanding common shares are and the common shares outstanding at the closing of this offering will be duly authorized, validly issued, paid up and non-rateable. The rights, preferences and privileges of holders of common stock are governed by, and may be affected by, the rights of holders of stock of any series of preferred stock that we may determine and issue in the future.

preferential actions

Upon completion of this offering, all of our previously outstanding convertible preferred stock will have been converted into common stock, there will be no authorized shares of our previously outstanding convertible preferred stock and we will have no outstanding preferred stock. Pursuant to the terms of our Amended and Consolidated Articles of Incorporation, effective immediately prior to the closing of this Offering, our Board of Directors has the authority to issue, without further action from our shareholders, until

50,000,000 shares of preferred stock in one or more series to determine from time to time the number of shares to be included in each such series in order to fully unissue the dividend, voting rights and other rights, preferences and privileges of the shares in each series and any qualifications, limitations or restrictions to increase or decrease the number of shares in such series, but not less than the number of shares then outstanding in that series.

Our Board of Directors may authorize the issuance of preferred stock carrying voting or conversion rights that may affect the voting or other rights of common stockholders. While the issuance of preferred stock provides flexibility with respect to potential acquisitions and other corporate purposes, it could, among other things, delay, prevent or prevent a change in our control and could adversely affect the market price of common stock, voting and other rights the holder of common shares. We currently have no plans to issue preferred stock.

options

As of September 30, 2022, 1,320,932 options to purchase our common shares were outstanding, of which 270,919 were vested and exercisable at that date. For more information on the terms of our 2020 Plan, see “Officials and Directors Compensation – Equity Incentive Plans – Equity Incentive Plan 2020”.

Registration Rights

Effective September 30, 2022, following the closing of this Offering, holders of 20,637,415 Common Shares, including any Common Shares issued upon automatic conversion into convertible preferred stock immediately prior to the closing of this Offering, will be entitled to the following registration rights those shares for public resale under the Securities Act pursuant to an investor rights agreement between us and certain investors. The registration of common stock as a result of the exercise of the following rights would permit the holders to deal in such common stock without restriction under the Securities Act when the applicable registration statement is declared effective.

Registration rights required

Formulate S-1. Should the holders of at least sixty percent (60%) of the registrable securities, at any time after six months from the effective date of the registration statement of which this Prospectus is a part, request in writing that we make a registration in respect of at least forty percent ( 40%) of the then outstanding registrable securities, we may be required to notify all holders of registrable securities of such application and provide them with an opportunity to participate in such registration and to use commercially reasonable efforts to complete such registration; provided, however, that we are not required to make such registration if, among other things, we have already made two registrations for holders of registrable securities in the previous 12 months in response to such request registration rights.

Formulate S-3. If at any time we are authorized under the Securities Act to register our stock on Form S-3 and holders of at least twenty percent (20%) of the registerable securities request in writing that we make a registration with respect to all or any portion of the outstanding registrable securities if the anticipated aggregate offering price, excluding fees, is at least US$4.0 million, we may be required to notify all holders of registrable securities of such application and offer them an opportunity to participate in such registration and use commercially reasonable efforts to solicit carry out such registration; provided, however, that we are not required to make such registration if, among other things, we have already made two filings on Form S-3 for holders of registrable securities in the preceding 12 months.

If the Holders applying for registration intend to market their Shares through an offering, the subscriber to such offering will have the right to limit the number of Shares to be subscribed for reasons relating to dealings in Shares in accordance with the investor's regulations Right Agreements.

Ride Registration Rights

If at any time after the closing of this offering we propose to register common stock under the Securities Act, subject to certain exceptions, holders of registerable securities have the right to so notify

register and record their interests in registrable securities. If our proposed registration involves an underwritten offering, the issuer administering such offering has the right to limit the number of shares to be subscribed for reasons related to the trading of the shares under the terms of the Investor Reduction Agreement.

Damage payment

Our Investor Rights Agreement contains standard mutual indemnification provisions under which we are obliged to indemnify holders of registerable securities for material errors or omissions in a registration statement attributable to us and they are obliged to compensate for relevant errors or omissions attributable to them to compensate.

Cost

In addition to subscription discounts and fees, we must pay any costs we incur in connection with any registration made pursuant to the exercise of those registration rights. These costs may include all registration and filing fees, printing costs, our attorneys' fees and expenses, reasonable fees and expenses of an attorney for deed holders, Blue Sky's fees and expenses and the cost of special audits of the register.

Termination of Registration Rights

Registration rights will expire (i) five years after the closing of this Offering, or (ii) with respect to a particular holder if Rule 144 or other similar exemption under the Securities Act applies to the sale of all Shares to that holder without restriction during such time a Deadline of three months without registration.

Anti-Acquisition Effects of Delaware Law and Our Charter and Articles of Incorporation

Certain provisions of the Delaware statute, our amended and updated Memorandum of Association, and our amended and updated Articles of Association contain provisions that may make the following transactions more difficult: an acquisition by us through a public offering; an acquisition by us through a proxy contest or otherwise; or the removal of our officers and acting directors. These provisions may complicate or prevent transactions that shareholders believe are in their best interests or in our best interests, including transactions that involve the payment of a premium above the market price of our shares.

These provisions, summarized below, are intended to prevent forced takeover practices and improper takeover bids. These provisions are also intended to encourage those who wish to gain control of us to first negotiate with our Board of Directors. We believe that the benefits of greater protection of our potential ability to negotiate with the proponent of a hostile or unsolicited proposal to acquire or reorganize us outweigh the disadvantages of rejecting such proposals as negotiations for such proposals lead to an improvement of their terms.

Preference shares not designated

The ability of our Board of Directors to issue, without stockholder action, up to 50,000,000 shares of Preferred Stock carrying no voting rights or other rights or preferences, as determined by our Board of Directors, could make any attempt to change control of us successful , affect. These and other provisions could delay hostile takeovers or delay changes in control or governance of our business.

general meetings

Our amended and restated Articles of Association provide that an extraordinary meeting of shareholders may only be convened by our Chairman, Executive Officer or President or by a majority vote of our Board of Directors.

Requirements for advance notice of nominations and shareholder proposals

Our Amended and Consolidated Articles of Association provide for prior notice procedures in relation to shareholder proposals to be presented at a shareholders meeting and the nomination of candidates for election as directors, except for nominations made by or at the direction of the Board of Directors or a committee of the Board of Directors.

Cancellation of Shareholder's Interest by Written Consent

Our amended and updated Memorandum of Association and Articles of Association repeal the right of stockholders to act by written consent without a meeting.

tiered board

Our amended and restated Articles of Association provide for our Board of Directors to be divided into three classes. The directors of each class will serve a three-year term, with one class being elected by our shareholders each year. For more information on the ranking of the Board of Directors, see Management - Board Composition and Board Election. This system of electing directors may deter third parties from trying to gain control of us as it generally makes it more difficult for shareholders to replace a majority of directors.

Removal of Directors

Our Amended and Consolidated Articles of Incorporation provide that no member of our Board of Directors may be removed from office except for cause and in addition to any other votes required by law upon the approval of at least two-thirds of the total votes cast of all of our voting shares then entitled to vote in the election of directors.

Shareholders without accumulated voting rights

Our amended and consolidated Articles of Incorporation do not allow shareholders to pool their votes in electing directors. As a result, holders of a majority of the outstanding shares of our common stock who are entitled to vote in an election of directors may elect any directors running for election if they so choose, except for directors to whom holders of our preferred stock may right have. choose.

Delaware Anti-Acquisition Law

We are subject to Section 203 of the Delaware General Corporate Law, which prohibits persons who are considered "prospective stockholders" from entering into a "business combination" with a publicly traded Delaware corporation for three years from the date such persons become prospective stockholders, it unless the business combination or transaction in which the person became a prospective shareholder has been approved in a required manner or another required exception applies. Generally, a “prospective shareholder” is a person who, together with affiliates and associates, owns 15% or more of the voting stock of a corporation or within three years prior to the determination of prospective shareholder status. Generally, a “merger” includes a merger, sale of assets or stock, or other transaction that results in a financial benefit to the proposed shareholder. The existence of this provision may have an anti-takeover effect in relation to transactions not previously approved by the Board of Directors.

forum choice

Our amended and updated Articles of Incorporation provide that the Delaware State Court of Chancery (the "Court of Chancery") shall be the sole and exclusive forum for the following types of suit or proceeding, unless we consent in writing to the selection of an alternative form hereunder Delaware statute or common law: (i) derivative claims or proceedings brought on our behalf; (ii) any claim alleging breach of fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents against us or our stockholders, creditors or other constituents; (iii) any cause of action to bring any claim against us arising out of any provision of the Delaware General Corporate Law or our amended and updated Memorandum of Association or Articles of Association; (iv) any act of interpretation, application, enforcement or determination of the validity of our instrument of incorporation or articles of incorporation; or (v) any claim alleging a claim governed by the Doctrine of Internal Affairs, in all cases

to the extent permitted by law. The provision does not apply to actions to enforce a duty or liability created by the Stock Exchange Act. In addition, our Amended and Consolidated Instrument of Incorporation provides that the federal district courts of the United States shall be the exclusive forum for the resolution of any claim establishing a cause or causes, unless we consent in writing to the election of an alternate forum of claims brought arising out of the Securities Act, including any causes of action brought against a defendant of any such claim. For the avoidance of doubt, this provision is intended to benefit and be enforceable for the benefit of us, our officers and directors, the insurers of offers giving rise to such a claim, and any other professional body whose profession warrants such a statement to any person or entity making a created or certified some of the documents on which the offer is based. In no event will shareholders be deemed to have waived our compliance with the federal securities laws and their rules and regulations. The applicability of similar jurisdiction clauses in the articles of incorporation of other companies has been challenged in court cases, and it is possible that a court has found these types of clauses to be inapplicable or unenforceable. Our amended and updated Articles of Incorporation also provide that any person or entity who purchases or acquires an interest in our common stock will be deemed to have given notice of and consented to such choice of venue.

Amendment of the Articles of Incorporation

Changing any of the above provisions, except for the provision allowing our Board of Directors to issue preferred stock, would require the approval of holders of at least two-thirds of the aggregate voting power of all of our outstanding voting shares.

Provisions of Delaware statutes, our amended and updated Articles of Incorporation, and our amended and updated Articles of Association may act to discourage others from attempting hostile takeovers and, as a result, may also prevent temporary fluctuations in the market price of our common stock that often result from actual or perceived hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of our board of directors and management. It is possible that these provisions may make it difficult to carry out transactions which shareholders might otherwise consider to be in their best interests.

Transfer Agent and Registrar

The transfer and registrar agent for our common stock will be American Stock Transfer & Trust Company LLC. The transfer and registrar address is 6201 15th Avenue, Brooklyn, New York 11219.

Nasdaq Global Market Listing

We are applying to list our common stock on the Nasdaq Global Market under the symbol "MLYS."

Limitations of Liability and Indemnity Issues

For a discussion of liability and indemnification, see Officers' and Directors' Compensation - Limitations and Indemnification Issues.

SHARES ELIGIBLE FOR FUTURE SALE

Immediately prior to this offering, there was no public market for our common stock. Future sales of significant quantities of our common stock in the public market, or the expectation that such sales might occur, could adversely affect the market price of our common stock. Although we have applied to list our common stock on the Nasdaq, we cannot assure you that there will be an active public market for our common stock.

Based on the number of common shares outstanding as of September 30, 2022 and assuming (i) the issuance of 10,000,000 shares pursuant to this offering, (ii) the automatic conversion of all of our outstanding convertible preferred shares into 20,637,415 common shares and the related reclassification of the carrying amount of preferred shares convertible into perpetual equity upon the closing of this offering, (iii) no exercise of the underwriters' option to purchase additional common shares, and (iv) no exercise of outstanding options that we will have a total of 37,056,653 outstanding common shares after completion of this offer.

Of those shares being sold in this offering, all of the shares being sold in this offering are freely transferable without restriction or further registration under the Securities Act, except for shares held by our “affiliates” as defined therein term in Rule 144 of the Securities Act. Shares purchased from our affiliates would be subject to the Rule 144 resale restrictions described below in addition to the hold period requirement.

The remaining 27,056,653 common shares will be restricted securities, as that term is defined in Rule 144 of the Securities Act. These restricted securities are only eligible for public sale if they are registered under the Securities Act or qualify for an exemption from registration under Rule 144 or Rule 701 of the Securities Act, each of which is summarized below. We anticipate that substantially all of these lawsuits will be subject to the 180-day hold period pursuant to the hold agreements described below.

lock contracts

We, our officers, directors and holders of substantially all of our securities agree with the Underwriters that for a period of 180 days from the date of this Prospectus, we or they will not, among other things and subject to certain exceptions, offer to: pledge, sell, contract of sale, sale of options or contract of sale, purchase of options or contract of sale, grant of any option, right or interest to sell or dispose of or transfer any common stock or convertible security exercisable or exchangeable for common stock require or require that we make a Filing a registration statement with respect to our common stock, or entering into an exchange or other agreement that transfers, directly or indirectly, the economic consequences of ownership of the common stock, in whole or in part, to another, or publicly declare an intention to do any of the above to take action. After the lockup period has expired, some of our shareholders are entitled to require us to register their shares under the Securities Act. See “—Registration Rights” below and “Description of Share Capital—Registration Rights”.

BofA Securities, Inc., Evercore Group L.L.C. and Stifel, Nicolaus & Company, Incorporated may, in their sole discretion, release all or any portion of the Restricted Securities at any time or from time to time before the end of the Restriction Period, in certain cases without public notice. There are no existing agreements between the underwriters and any of our shareholders to sign a blocking agreement agreeing to the sale of shares prior to the end of the blocking period.

Upon expiration of the blocking period, substantially all shares subject to such blocking restrictions will be admitted for sale, subject to the restrictions discussed above.

Rule 10b5-1 Commercial Plans

Upon the closing of this Offering, certain of our officers, directors and significant stockholders may enter into written plans, known as Rule 10b5-1 dealing plans, under which they will appoint a brokerage firm to buy or sell shares of our common stock for a specified period of time, to diversify your wealth and investments. Under these 10b5-1 trading plans, a broker may execute trades in accordance with parameters set by the director, director or shareholder upon entry into the plan without further direction from that director, director or shareholder. Not such sales

commences upon termination of any applicable lock-up agreements entered into by such officer, director or shareholder in connection with this Offering.

Rule 144

Affiliate Resellers of Restricted Titles

Generally, pursuant to Rule 144 currently in force, beginning 90 days after the effective date of the registration statement to which this Prospectus relates, a person who is an affiliate of ours or at any time during the 90 days prior to a sale and the common stock of our common stock for at least six months would have the right to sell in "broker transactions" or certain "risk-free capital transactions" or to market makers a specified number of shares every three one-month periods not to exceed the greater of the following :

•1% of the then outstanding common shares, which will equal approximately 370,567 shares immediately following this offering, assuming the underwriters' option to purchase additional shares is not exercised; or

•the average weekly trading volume of our common stock on the Nasdaq during the four weeks prior to the filing of a Form 144 notice relating to this sale.

An “Affiliate” is a person who controls, is controlled by, or is under common control with an issuer, directly or indirectly through one or more intermediaries. Affiliate resellers under Rule 144 are also subject to the availability of current public information about us. If the number of shares sold by an affiliate under Rule 144 during a three-month period exceeds 5,000 shares or has a total sale price greater than $50,000, the seller must also file a Form 144 notice with the SEC and the Nasdaq simultaneously with placing a sell order with the broker or executing a sell directly with a market maker.

Unaffiliated Resellers of Restricted Titles

Generally, under current Rule 144, beginning 90 days from the effective date of the registration statement to which this Prospectus relates, a person who is not an affiliate of us at the time of sale and was not an affiliate at the time of sale at any time during the three months prior to a sale, and anyone who has owned shares of our common stock for at least six months but less than one year may sell such shares only subject to the availability of current public information about us. If such a person holds our shares for at least one year, that person may resell under Rule 144(b)(1) without regard to Rule 144 restrictions, including the 90-day requirement for public companies and the current information requirement.

Unaffiliated Resellers are not subject to the form of sale, quantity limitation, or notification requirements of Rule 144.

Rule 701

Generally, under Rule 701 currently in force, any employee, director, officer, consultant or director of an issuer who purchases stock of the issuer in connection with a compensatory measure or stock option plan or other written agreement prior to the effective date of a declaration registration after the Securities Act have the right to sell these shares 90 days after the Rule 144 Effective Date. An affiliate of the issuer may resell shares under Rule 144 without having to comply with the hold period requirement, and non-affiliated companies of the issuer may resell shares under rule 144 without having to comply with current public information and hold requirements. However, substantially all Rule 701 stock is subject to the blocking covenants described above and will not be admitted for sale under Rule 144 until the restrictions set forth in those covenants have expired.

The SEC has indicated that Rule 701 applies to typical options granted by an issuer before they are subject to reporting requirements under the Exchange Act, along with stocks acquired upon the exercise of such options, including exercises after an issuer becomes reportable Stock Exchange Act Requirements.

stock plans

We intend to file one or more registration statements on Form S-8 under the Securities Act to register all common stock subject to outstanding stock options and common stock issued or to be issued under our stock incentive plans and employee stock purchase plan. We expect to file the registration statement for the shares offered under these share plans shortly after the date of this Prospectus, which will permit resale of these shares by unaffiliated companies in the public market without restriction under the Securities Act and sale by affiliated companies Businesses in the public market, subject to compliance with the resale provisions of Rule 144.

Registration Rights

Upon completion of this Offering, holders of 20,637,415 Common Shares, including any Common Shares issued upon automatic conversion of our Preferred Stock, which may be converted into Common Stock immediately prior to the closing of this Offering, will be entitled to various rights with respect to the registration of such shares Shares pursuant to the Securities Act as of the closing of this offering. Registration of such shares under the Securities Act would result in such shares becoming freely tradable without restriction under the Securities Act immediately upon the effective date of registration, except for shares purchased by our affiliates. See "Description of Share Capital - Registration Rights" for more information. The Shares which are the subject of the Registration Statement will be admitted to public sale upon the expiration or waiver of the terms of the lock-up agreements described above.

US FEDERAL INCOME TAX CONSEQUENCES FOR NON-US OWNERS

The following discussion is a summary of the major US federal income tax implications for non-Americans. Holders (as defined below) are purchasing, owning and disposing of our common stock issued pursuant to this offering, but it is not intended to be a complete analysis of all possible tax effects. The effects of other US federal tax laws, such as B. Inheritance and gift tax laws, and applicable state, local or non-US tax laws are not discussed. This discussion is based on the United States Internal Revenue Code of 1986, as amended (the Code), treasury regulations made thereunder, court decisions and published administrative decisions and pronouncements of the United States Internal Revenue Service (the IRS), from time to time. Case applies from this date. These powers are subject to change or different interpretations. Any change or different interpretation may apply retrospectively in a way that could adversely affect a non-US country. Support. We are not, and will not, seek a ruling from the IRS on any of the matters discussed below. There can be no assurance that the IRS or any court will not take a different position as described below with respect to the tax consequences of the purchase, holding and disposal of our common stock.

This discussion is limited to outside the US. Holders who hold our common stock as “equity” within the meaning of Section 1221 of the Code (generally property held for investment). This discussion does not address all relevant U.S. federal income tax consequences for a foreigner. The holder's special circumstances, including the impact of the Medicare contribution tax on net investment income and the alternative minimum tax. Additionally, it does not address consequences relevant outside of the United States. Holders subject to special rules including but not limited to:

•American expatriates and former citizens or long-term residents of the United States;

•Persons who hold our common stock as part of a hedging, straddling or other risk mitigation strategy or as part of a conversion transaction or other integrated investment;

•banks, insurance companies and other financial institutions;

•securities brokers, dealers or dealers;

•"controlled foreign corporations," "passive foreign investment corporations," and corporations that accumulate profits to avoid US federal income tax;

•partnerships or other entities or arrangements treated as partnerships for US federal income tax purposes (and their investors);

•tax-exempt organizations or governmental organizations;

•persons who are believed to be selling our common stock in accordance with the provisions of the Constructive Selling Code;

•Individuals who hold or receive our common stock as compensation as a result of the exercise of an employee stock option or otherwise;

•tax-advantaged retirement plans; And

•“qualifying foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all interests of which are held by qualifying foreign pension funds.

If a corporation or arrangement treated as a partnership for U.S. federal income tax purposes owns our common stock, the tax treatment of a partner in the partnership depends on the status of the partner, the activities of the partnership, and certain determinations made at the partner level. . Accordingly, partnerships that own our common stock and partners in such partnerships should consult their tax advisors regarding their US federal income tax implications.

THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT A REVIEW COMMITTEE. INVESTORS SHOULD CONSULT THEIR TAX ADVISERS REGARDING THE APPLICATION OF THE US FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AND ANY TAX CONSEQUENCES OF THE PURCHASE, OWNERSHIP AND SUPPLY OF OUR

COMMON CLAIMS ARISING OUT OF US FEDERAL TAX LAWS OR THE LAWS OF ANY STATE, LOCAL OR NON-US STATE. TAX JURISDICTION OR UNDER APPLICABLE INCOME TAX TREATIES.

Discontinuation outside of US support

For purposes of this discussion, a “non-U.S. Holder” means any beneficial owner of our common stock that is not a “US person” or an entity treated as a partnership for US federal income tax purposes. A US person is a person subject to, is, or will be subject to US federal income tax for US tax purposes:

•a person who is a citizen or resident of the United States;

•a corporation incorporated or organized under the laws of the United States, a state thereof, or the District of Columbia;

•an estate, the income of which is subject to US federal income tax regardless of source; or

•a Fund that is (i) subject to the primary supervision of a US court and the control of one or more “United States persons” (as defined in Section 7701(a)(30) of the Code), or (ii) has a valid election to be treated as a United States citizen for US federal income tax purposes.

distributions

As described in the Dividend Policy section, we do not expect to declare or pay cash dividends to the holders of our common stock in the foreseeable future. However, if we make cash distributions or capital distributions on our common stock, those distributions constitute dividends for U.S. federal income tax purposes to the extent paid out of our current or retained earnings and profits, as determined under U.S. federal income tax rules. Amounts that are not treated as dividends for US federal income tax purposes constitute a return of capital and will first be allocated and reduced to a non-US investor. The holder's adjusted tax base on its common stock, but not below zero. Any excess will be treated as a capital gain and treated as described under “—Sale or Other Chargeable Disposal” below.

Subject to the discussion below regarding effectively connected income, dividends paid to non-US holders are subject to US federal withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate under a US tax treaty). applicable income tax, provided the non-US holder provides a valid IRS Form W-8BEN or W-8BEN-E (or other applicable documentation) showing eligibility for the lower treaty fee). If a non-U.S. holder holds the shares through a financial institution or other intermediary, the non-U.S. The holder must submit the relevant documents to the intermediary, who must then submit a certificate, directly or through other intermediaries, to the competent withholding authority. A non-US owner who fails to provide timely documentation but is eligible for a reduced contract fee may receive a refund of any excess amounts withheld by filing a timely refund application with the IRS. Non-US owners should consult their tax advisors regarding their entitlement to benefits under an applicable income tax treaty.

When dividends paid to a non-US holder are effectively connected to the non-US holder. Trade or business conduct of a non-US Holder in the United States (and, if required by an applicable income tax treaty, the non-US Holder maintains a permanent establishment or fixed base in the United States from which such dividends are attributable), the Non -US holder Non US. The holder will be exempt from the US federal withholding tax described above. To claim the exception, the non-U.S. The holder must provide the appropriate withholding authority with a valid IRS Form W-8ECI stating that the dividends are effectively connected to the country outside the United States. Conduct of the owner of a trade or business within the United States.

All effectively related dividends are subject to US federal income tax based on net income at regular rates. A non-US corporate holder may also be subject to income tax at a rate of 30% (or such lower rate as may be set by an applicable income tax treaty) on such effectively related dividends adjusted for certain items . Outside the United States, holders should consult their tax advisors regarding applicable tax treaties, which may set different rules.

Sale or other chargeable disposal

Subject to the discussion below regarding withholding and withholding taxes under FATCA (defined below), a holder is not subject to U.S. federal income tax on gains realized on a sale or other taxable disposition of our common stock unless:

•the gain is effective with the non-U.S. Conduct of a trade or business owner in the United States (and, if required under an applicable income tax treaty, the non-US owner maintains a permanent establishment or fixed base in the United States from which such gain is attributable);

•Non-US Holder is a non-resident alien individual who resides in the United States for at least 183 days during the tax year of disposal and meets certain other requirements; or

•Our common stock constitutes an interest in US real estate (USRPI) by virtue of our status as a corporation holding US real estate (USRPHC) for US federal income tax purposes.

The profit described in the first item above is generally subject to US federal income tax based on net income at regular rates. A non-US holder that is a corporation may also be subject to branch profits tax at a rate of 30% (or such lower rate as may be set by an applicable income tax treaty) on such effectively connected profits, which is adjusted for certain items.

A non-U.S. holder described in the second bullet above is subject to U.S. federal income tax at the rate of 30% (or the lower rate established by an applicable federal income tax treaty) on the gain realized from the sale or other taxable disposal Income from our common stock that can be offset against US source capital losses from non-US companies. Owner (even if the individual is not considered a resident of the United States), provided that the individual is not a resident of the United States. The holder timely filed US federal income tax returns related to such losses.

With respect to the third point above, we believe that we are not currently a USRPHC and do not intend to become a USRPHC. However, because determining whether we are a USRPHC depends on the fair market value of our USRPIs relative to the fair market value of our non-US real estate holdings and our other business assets, there can be no assurance that we are not currently a USRPHC or will be in not become one in the future. Even if we are or become a USRPHC, gains from the sale or other taxable disposition of our common stock by a non-US holder are not subject to US federal income tax if our common stock is "regularly traded" as defined in applicable Treasury Regulations, in an established securities market, and such securities outside of the United States. The holder actually owned and believed to own 5% or less of our common stock during the five-year period ending on the date of sale or other taxable disposal or the date of sale outside the United States, whichever is shorter. detention of the holder.

Outside the United States, holders should consult their tax advisors regarding potentially applicable income tax treaties that may set different rules.

Backup Information and Retention Reports

Dividend payments on our common stock are not subject to withholding tax unless the applicable withholding tax authority has actual knowledge or reason to believe that the holder is a U.S. citizen and the holder certifies that he is not a U.S. citizen., such as by providing a valid IRS Form W-8BEN, W-8BEN-E, or W-8ECI or otherwise establish an exemption. However, informational returns are required to be filed with the IRS in connection with distributions of our common stock to non-US investors. regardless of whether these distributions are dividends or whether any tax has actually been withheld. In addition, proceeds from the sale or other taxable disposition of our common stock in the United States or through certain affiliated U.S. brokers are generally subject to withholding or reporting of information unless the applicable withholding agent obtains the certification described above and does not have actual Knowledge or reason to know that such holder is a United States citizen, or the holder otherwise establishes an exemption. Proceeds from a sale of our common stock made through a non-US branch of a non-US broker are generally not subject to security withholding or disclosure.

Copies of information statements filed with the IRS may also be provided under the terms of any treaty or agreement applicable to the tax authorities of the country in which the foreign holder resides or is domiciled.

Withholding tax is not an additional tax. Any amounts withheld under security withholding rules may be allowed as a refund or credit against a foreigner. The holder's US federal income tax liability, provided the required information is provided to the IRS in a timely manner.

Additional withholding tax on payments to foreign accounts

Withholding taxes may be levied on certain types of payments to non-US financial institutions and other non-US entities under Sections 1471 through 1474 of the Code (these sections are commonly referred to as the Foreign Accounts Tax Compliance Act (FATCA)). American . Specifically, a 30% withholding tax may be imposed on dividends, or subject to the proposed Treasury Regulations discussed below, gross proceeds from the sale or other disposition of our common stock paid to a "foreign financial institution" or "non-financial foreign financial institution" (each as defined in the Code), unless (i) the FFI assumes certain due diligence and reporting requirements, (ii) the non-financial foreign entity certifies that it has no “substantial U.S. owner” (as defined in the Code). Code) or provide identifying information about each significant U.S. owner, or (iii) the FFI or non-financial entity is eligible for an exception to these rules. If the beneficiary is an FFI and is subject to the due diligence and reporting requirements of clause (i) above, it must enter into an agreement with the U.S. Treasury Department requiring, among other things, it to identify accounts held by certain "specified US persons” or “United States-owned foreign entities” (each as defined in the Code), annually report certain information about those accounts, and withhold 30% on certain payments to noncompliant FFIs and other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the United States on FATCA may be subject to different rules.

In accordance with applicable Treasury Department regulations and administrative policies, FATCA withholding tax generally applies to dividend payments on our common stock. While FATCA withholding tax would also apply to gross proceeds payments from the sale or other disposal of Shares effective January 1, 2019, the proposed Treasury Regulations eliminate FATCA withholding tax on gross proceeds entirely. Taxpayers (including applicable withholding tax agents) can generally rely on these proposed Treasury Regulations until the final Treasury Regulations are issued. There is no guarantee that the final financial regulations will provide an exemption from FATCA withholding on gross income.

Prospective investors should consult their tax advisors regarding the possible application of FATCA withholding tax to their investment in our common stock.

INSURANCE

BofA Securities, Inc., Evercore Group L.L.C. and Stifel, Nicolaus & Company, Incorporated are acting as agents for each of the Underwriters listed below. Subject to the terms set forth in a subscription agreement between us and the underwriters, we have agreed to sell to the underwriters and each of the underwriters has agreed, individually and not collectively, to purchase from us the number of shares of Common Stock listed below are listed next to your name.

Subject to the terms set forth in the Subscription Agreement, the Underwriters have individually, and not collectively, agreed to purchase all Shares sold under the Subscription Agreement, should such Shares be purchased. In the case of a defaulting Subscriber, the subscription agreement provides that the defaulting Subscriber's purchase commitments may be increased or the subscription agreement may be terminated.

We agree to indemnify the various underwriters against certain liabilities, including obligations under the Securities Act, or to share in any payments the underwriters may have to make in connection with such liabilities.

The Underwriters are offering the Shares subject to prior sale if, how and if issued and accepted by them, subject to the approval of legal matters by their counsel, including the validity of the Shares and other terms contained in the Subscription Agreement, such as receipt of certificates and legal opinions by the underwriters. Subscribers reserve the right to withdraw, cancel or amend any public offer, and to refuse any order, in whole or in part.

Commissions and Rebates

Representatives have informed us that the underwriters initially propose to offer the shares to the public at the public offering price shown on the cover of this prospectus and to dealers at that price less a concession of not more than $ per share. After the initial offering, the public offering price, concession or other terms of the offering may be changed.

The following table shows the public offer price, the purchase discount and the result before costs for us. The information assumes that the underwriters will not, or fully, exercise their option to purchase additional shares.

The offering cost without subscription discount is estimated at $3.3 million and will have to be paid by us. We also agree to reimburse the underwriters for their costs related to the settlement of this offering with the Financial Sector Regulatory Authority or FINRA. worth up to $40,000.

Option to purchase additional shares

We are granting underwriters an option, exercisable 30 days after the date of this prospectus, to purchase up to 1,500,000 additional shares at the public offering price less the subscription discount. If the subscribers exercise this option, they must, subject to the terms contained in the Subscription Agreement, purchase a number of additional Shares proportional to the subscriber's starting value as set out in the table above.

No sale of similar titles

We, our officers and directors and our other existing security holders agree not to sell or transfer any common stock or securities convertible, exchangeable or exercisable into common stock (collectively, the Lock-Up securities). without the prior written consent of BofA Securities, Inc., Evercore Group L.L.C. and Stifel, Nicolaus & Company, Incorporated. In particular, with certain limited exceptions, we and such other persons do not agree, directly or indirectly:

•offering, pledging, selling or contracting for the sale of common stock;

•sell an option or contract to purchase common stock;

•purchase an option or contract to sell common stock;

•granting of options, rights or guarantees for the sale of common stock;

•lend, sell or transfer common stock;

•require or require us to file or file in confidence a registration statement relating to the Common Stock;

•enter into any swap or other arrangement that transfers, in whole or in part, the economic consequence of ownership of common stock, whether such swap or transaction is settled by delivery of stock or other securities, in cash or otherwise; or

•publicly announce the intention to do any of the foregoing.

This lock-up clause applies to all Lock-Up Securities now held or subsequently acquired or controlled by or subsequently acquired by the Subscriber. BofA Securities, Inc., Evercore Group L.L.C. and Stifel, Nicolaus & Company, Incorporated may, in its sole discretion, release the common stock and other securities subject to the lock-up agreements described above, in whole or in part, at any time with or without notice.

Nasdaq Global Market Listing

We are applying to list our common stock on the Nasdaq Global Market under the symbol "MLYS."

Prior to this offering, there was no public market for our common stock. The IPO price will be determined by negotiation between us and the nominees. In addition to prevailing market conditions, the factors to consider when determining the IPO price are:

•the valuation multiples of publicly traded companies that representatives believe are comparable to ours;

•our financial information;

•the history and prospects of our company and the industry in which we compete;

•an evaluation of our management, its past and present operations and the prospects and timing of our future earnings;

•the current status of our development; And

•the above factors relating to market values ​​and various valuation measures of other companies engaged in activities similar to ours.

An active trading market for the stock may not develop. It is also possible that the shares will not trade at or above the IPO price on the public market after the offering.

The underwriters do not expect to sell more than 5% of the shares to accounts over which they exercise discretionary powers.

Price stabilization, short positions and penalty bidding

Until the distribution of shares is complete, SEC regulations may prevent underwriters and distribution group members from offering and purchasing our common stock. However, agents may participate in transactions that stabilize the price of common stock, such as B. Offers or purchases to establish, set or maintain that price.

In connection with the Offering, underwriters may buy and sell our common stock on the open market. These transactions may include short sales, open market purchases to cover positions created by short sales and stabilization transactions. In short sales, underwriters sell more shares than they have to buy in the offering. "Covered" short sales are sales for an amount no greater than the underwriters' option to purchase additional shares described above. Underwriters may close covered short positions by exercising their option to purchase additional shares or by purchasing shares on the open market. In determining the source of shares to close out the covered short position, the underwriters will consider, among other things, the price of shares available for purchase on the open market compared to the price at which they can purchase shares through the option granted to them. "Naked" short selling is overselling such an option. Underwriters must close out any short positions by buying shares on the open market. An outright short position is more likely to be established if underwriters are concerned that the price of our common stock may come under pressure after open market pricing, which could adversely affect investors participating in the offering. Stabilization transactions consist of multiple offerings or purchases of common stock made by underwriters in the open market prior to the closing of the offering.

Subscribers can also impose a penalty offer. This occurs when a particular underwriter reimburses the underwriters for a portion of the underwriting rebate that that underwriter received as a result of agents repurchasing shares sold by or for the account of that underwriter in stabilization or short hedging transactions.

Similar to other purchase transactions, underwriter purchases to cover underwriter short sales may cause the market price of our common stock to increase or maintain, or prevent or delay a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that would otherwise exist in the open market. Underwriters may conduct these transactions on the Nasdaq Global Market, over the counter or otherwise.

Neither we nor any of the underwriters make any representations or predictions as to the direction or extent of any impact that the transactions described above may have on the price of our common stock. Furthermore, neither we nor any of the underwriters make any representations that agents will participate in these transactions or that, once initiated, these transactions will not be terminated without notice.

Electronic distribution

In connection with the Offering, some of the underwriters or stockbrokers may distribute prospectuses by electronic means, such as email.

other relationships

The Underwriters and their respective affiliates are full-service financial institutions engaged in a variety of activities, including sales and trading, commercial and investment banking, consulting, investment management, investment research, investing, hedging, market making, broking and other financial activities and

non-financial activities and services. Some of the Underwriters and their affiliates have, in the ordinary course of business, engaged in investment banking and other commercial transactions with us or our affiliates and may do so in the future. You received, or may in the future receive, customary fees and commissions for these transactions.

In addition, underwriters and their affiliates may, in the ordinary course of their business, make or maintain a wide range of investments and actively trade in debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own .-account and for its customers' accounts. Such securities investments and activities may involve securities and/or instruments of us or our affiliated companies. Underwriters and their affiliates may also make investment recommendations and/or publish or provide independent research opinions relating to such securities or financial instruments and may hold or recommend clients to take long and/or short positions in such securities and instruments.

Notice to prospective investors in the European Economic Area

With respect to any member state of the European Economic Area (each a Relevant State), prior to the publication of a prospectus in relation to the Shares, no Shares pursuant to this Offering have been or will be publicly offered in such relevant State or have been approved by the competent authority of such relevant State or, as the case may be, in a other Relevant Jurisdiction and notified to the competent authority of that Relevant Jurisdiction, all in accordance with the Prospectus Regulation), except that offers of Shares may be made public in that Relevant Jurisdiction at any time subject to the following exceptions in accordance with the Prospectus Regulation:

liketo any legal entity that is a qualified investor within the meaning of the Prospectus Regulation;

B.to fewer than 150 individuals or entities (who are not qualified investors within the meaning of the Prospectus Regulations), subject to the prior approval of the agents for such an offer; or

c.in any other circumstances covered by Article 1(4) of the Prospectus Regulation,

provided that such offering of shares shall not oblige the Company or any applicant to publish a prospectus in accordance with Article 3 of the Prospectus Regulation or to supplement a prospectus in accordance with Article 23 of the Prospectus Regulation.

Any person in a Relevant Jurisdiction who initially purchases Shares or to whom an offer is made will be deemed to have represented, acknowledged and agreed to the Company and the Underwriters that he is a Qualified Investor within the meaning of the Prospectus Regulations.

In the event that Shares are offered to a financial intermediary, as that term is used in Article 5(1) of the Prospectus Regulations, each such financial intermediary will be deemed to have declared, acknowledged and agreed that the Shares acquired by it in the offering were not acquired on a non-discretionary basis on behalf of any person, nor were they acquired with intent to offer or resell them to any person in circumstances which would result in a public offering, other than their offering or resale in a Relevant Jurisdiction to qualified investors in circumstances under which the prior consent of the representatives has been obtained for any offer or resale proposal.

The Company, the Underwriters and their respective affiliates rely on the truth and accuracy of the foregoing representations, confirmations and agreements.

For the purposes of this provision, the term "public offering" in relation to Shares in a Relevant Jurisdiction means the transmission, in any form and by any means, of sufficient information about the terms of the offering and any Shares being offered to enable an investor to decision to purchase or subscribe for Shares, the term “Prospectus Regulation” means Regulation (EU) No. 2017/1129.

The above selling restriction is in addition to any other selling restrictions listed below.

Notice to prospective UK investors

In relation to the United Kingdom (UK), no Shares pursuant to this offering have been and will not be offered to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom pursuant to the Regulations of the UK Prospectuses and the FSMA, except that offers of Shares may be made to the public in the UK at any time subject to the following exceptions under the UK Prospectus Regulations and the FSMA:

liketo any body corporate which is a qualifying investor within the meaning of the UK Prospectus Regulations;

B.to fewer than 150 individuals or entities (other than qualifying investors within the meaning of the UK Prospectus Regulations), subject to the prior consent of the Agents to any such offer; or

c.at any time in other circumstances falling within Section 86 of FSMA,

provided that no offer of Shares will require the Company or any Underwriter to publish a prospectus in accordance with Section 85 of the FSMA or Article 3 of the UK Prospectus Regulations or to amend a prospectus in accordance with Article 23 of the UK Prospectus Regulations.

Any UK person initially purchasing Shares or to whom an offer is made will be deemed to have represented, acknowledged and agreed to the Company and the Underwriters that they are a qualifying investor within the meaning of the UK Prospectus Regulations.

In the event that Shares are offered to a financial intermediary, as that term is used in Article 5(1) of the UK Prospectus Regulations, each such financial intermediary will be deemed to have declared, acknowledged and agreed that the Shares it has purchased are included in the offering was not acquired on a non-discretionary basis on behalf of or with a view to offering or reselling it to any person in circumstances that would result in a public offering other than its offering or resale in the United States to qualified investors in circumstances in which prior approval of agents has been obtained for any proposed offer or resale.

The Company, the Underwriters and their respective affiliates rely on the truth and accuracy of the foregoing representations, confirmations and agreements.

For the purposes of this provision, the term “public offering” in relation to UK Shares means the giving of, in any form and by any means, sufficient information about the terms of the offering and any Shares to be offered to enable an investor to register for the purchase or decide to subscribe for Shares, the term “UK Prospectus Regulation” means Regulation (EU) 2017/1129 as it forms part of the national enforcement of the European Union (Withdrawal) Act 2018 and the term “FSMA” means the Financial Services and Markets Act 2000.