Mineralys Therapeutics, Inc. 10-K

Item 9A. Controls and Procedures Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Annual Report. Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Annual Report on Internal Control Over Financial Reporting Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13(a)-15(f) and 15(d)-15(f) under the Exchange Act. Management assessed our internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Management’s assessment included evaluation of elements such as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment. Based on this assessment, management has concluded that our internal control over financial reporting was effective as of the end of the fiscal year to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external reporting purposes in accordance with U.S. GAAP. We reviewed the results of management’s assessment with the audit committee of our board of directors. Our auditors will not be required to formally opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer an “emerging growth company” as defined in the JOBS Act. Changes in Internal Control Over Financial Reporting There have been no changes in our internal control over financial reporting during the three months ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. – 106 – Item 9B. Other Information During the three months ended December 31, 2023, two of our officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any non-Rule 10b5-1 trading arrangement (as defined in the SEC’s rules). The material terms of these Rule 10b5-1 trading arrangements are described below: Name and Title Action Taken Type of Trading Arrangement Nature of Trading Arrangement Duration of Trading Arrangement Number of Securities David Rodman, M.D. , Chief Medical Officer Adoption 11/14/2023 Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c) Sale of the Company’s common stock pursuant to the terms of the plan 2/8/24 - 12/31/2024 (1) Adam Levy , Chief Financial Officer Adoption 11/14/2023 Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c) Sale of the Company’s common stock pursuant to the terms of the plan 6/11/2024 - 1/30/2026 (2) ________ (1) The executive’s Rule 10b5-1 trading arrangement provides for the sale of up to (i) 10,034 shares of common stock and (ii) 45,436 shares of common stock subject to a stock option award granted to Dr. Rodman that vests ratably over time. (2) The executive’s Rule 10b5-1 trading arrangement provides for the sale of up to 172,117 shares of common stock subject to a restricted stock award granted to Mr. Levy that vests ratably over time. Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections Not Applicable. – 107 – Part III Item 10. Directors, Executive Officers and Corporate Governance The information required by this item is incorporated by reference to our 2024 Proxy Statement. Our Board has adopted a written code of business conduct and ethics that applies to our directors, officers, and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. Our code of business conduct and ethics is available under the Corporate Governance section of our website at www.mineralystx.com . In addition, we intend to post on our website all disclosures that are required by law or the listing standards of Nasdaq concerning any amendments to, or waivers from, any provision of the code. We have included our website address in this Annual Report solely as an inactive textual reference. The reference to our website address does not constitute incorporation by reference of the information contained at or available through our website, and you should not consider it to be a part of this Annual Report. Item 11. Executive Compensation The information required by this item is incorporated by reference to our 2024 Proxy Statement. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this item is incorporated by reference to our 2024 Proxy Statement. Item 13. Certain Relationships and Related Transactions, and Director Independence The information required by this item is incorporated by reference to our 2024 Proxy Statement. Item 14. Principal Accountant Fees and Services The information required by this item is incorporated by reference to our 2024 Proxy Statement. – 108 – Part IV Item 15. Exhibit and Financial Statement Schedules 1. Financial Statements The financial statements of Mineralys Therapeutics, Inc., together with the report thereon of Ernst & Young LLP, an independent registered public accounting firm (PCAOB ID No. 42), are included in this Annual Report contained in Part II, Item 8. Financial Statements and Supplementary Data. 2. Finance Statement Schedules All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto. 3. Exhibits A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this Annual Report and is incorporated herein by reference. Item 16. Form 10-K Summary None. EXHIBIT INDEX Exhibit Number Incorporated by Reference Filed Herewith Exhibit Description Form Date Number 3.1 Amended and Restated Certificate of Incorporation 8-K 2/14/23 3.1 3.2 Amended and Restated Bylaws 8-K 2/14/23 3.2 4.1 Specimen stock certificate evidencing the shares of common stock S-1/A 2/2/23 4.1 4.2 Amended and Restated Investors’ Rights Agreement, dated June 1, 2022, by and among the Registrant and certain of its stockholders S-1/A 2/2/23 4.2 4.3 Form of Pre-Funded Warrant 8-K 2/8/24 4.1 4.4 Description of Registered Securities x 10.1# Mineralys Therapeutics, Inc. Amended and Restated 2020 Equity Incentive Plan and form of stock option agreement and form of restricted stock agreement thereunder S-1/A 2/2/23 10.1 10.2# Mineralys Therapeutics, Inc. 2023 Incentive Award Plan and form of stock option agreement and form of restricted stock unit agreement thereunder S-1/A 2/2/23 10.2 10.3# Mineralys Therapeutics, Inc. 2023 Employee Stock Purchase Plan S-1/A 2/2/23 10.3 10.4# Non-Employee Director Compensation Policy S-1/A 2/2/23 10.4 10.5#† Amended and Restated Employment Letter Agreement, dated February 1, 2023, by and between Jon Congleton and the Registrant S-1/A 2/2/23 10.5 10.6#† Amended and Restated Employment Letter Agreement, dated February 1, 2023, by and between David Rodman, M.D. and the Registrant S-1/A 2/2/23 10.6 10.7#† Amended and Restated Employment Letter Agreement, dated February 1, 2023, by and between Adam Levy and the Registrant S-1/A 2/2/23 10.7 – 109 – 10.8# Form of Indemnification Agreement for Directors and Officers S-1 1/18/23 10.8 10.9† License Agreement, dated July 9, 2020, between the Registrant and Mitsubishi Tanabe Pharmaceutical Corporation S-1 1/18/23 10.9 10.10 Securities Purchase Agreement, dated February 7, 2024, by and between the Registrant and each of the purchasers party thereto 8-K 2/8/24 10.1 23.1 Consent of Ernst & Young LLP, independent registered public accounting firm x 31.1 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 x 31.2 Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 x 32.1* Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 x 32.2* Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 x 97.1 Mineralys Therapeutics, Inc. Policy for Recovery of Erroneously Awarded Compensation x 101.INS XBRL Instance Document x 101.SCH XBRL Taxonomy Extension Schema Document x 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document x 101.DEF XBRL Taxonomy Extension Definition Linkbase Document x 101.LAB XBRL Taxonomy Extension Label Linkbase Document x 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document x 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) x __________________ # Indicates management contract or compensatory plan. † Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601 of Regulation S-K because it is both not material and is the type that the registrant treats as private or confidential. * This certification is deemed not filed for purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. – 110 – SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. MINERALYS THERAPEUTICS, INC. Date: March 21, 2024 By: /s/ Jon Congleton Jon Congleton Chief Executive Officer – 111 – Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities held on the dates indicated. Signature Title Date /s/ Jon Congleton Chief Executive Officer (principal executive officer) March 21, 2024 Jon Congleton /s/ Adam Levy Chief Financial Officer and Secretary (principal financial and accounting officer) March 21, 2024 Adam Levy /s/ Brian Taylor Slingsby Executive Chairman March 21, 2024 Brian Taylor Slingsby, M.D., Ph.D., M.P.H. /s/ Srinivas Akkaraju Director March 21, 2024 Srinivas Akkaraju, M.D., Ph.D. /s/ Alexander Asam Director March 21, 2024 Alexander Asam, Ph.D. /s/ Derek DiRocco Director March 21, 2024 Derek DiRocco, Ph.D. /s/ Olivier Litzka Director March 21, 2024 Olivier Litzka, Ph.D. /s/ Daphne Karydas Director March 21, 2024 Daphne Karydas /s/ Glenn Sblendorio Director March 21, 2024 Glenn Sblendorio – 112 –