Achieve Life Sciences Inc 2025年度报告

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF1934 Commission File Number 033-80623 Achieve Life Sciences, Inc.(Exact name of the registrant as specified in its charter)Delaware95-4343413(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.)22722 29th Drive SE, Suite 100, Bothell, WA 980211040 West Georgia Street, Suite 1030, Vancouver, B.C. V6E 4H1(Address of principal executive offices, including zip code)(604) 210-2217(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Title of Each ClassTradingSymbol(s)Name of Exchange on Which RegisteredCommon Stock, par value $0.001 per shareACHVThe Nasdaq Stock Market LLCSecurities registered pursuant to Section 12(g) of the Act:None Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementsfor the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” inRule 12b-2 of the Exchange Act. Large accelerated filer Non-accelerated filer If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal controlover financial reporting under Section 404(b) of the Sarbanes Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued itsaudit report.☐If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.).Yes☐No☒ As of June 30, 2025, the aggregate market value of the registrant’s Common Stock held by non-affiliates of the registrant was $103,958,994 computed withreference to the price at which the Common Stock was last sold on June 30, 2025. As of March 24, 2026, 53,239,988 shares of the registrant’s Common Stock wereoutstanding.DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant’s Definitive Proxy Statement for its 2026 Annual Meeting of Stockholders, to be filed within 120 days of the Registrant’s fiscalyear ended December 31, 2025, is incorporated by reference into Part III of this Annual Report on Form 10-K. Auditor Firm ID: 271 Auditor Name: PricewaterhouseCoopers LLP Auditor Location: Vancouver, Canada Achieve Life Sciences, Inc. Table of Contents PART I2ITEM 1.BUSINESS5ITEM 1A.RISK FACTORS21ITEM 1B.UNRESOLVED STAFF COMMENTS54ITEM 1C.CYBERSECURITY54ITEM 2.PROPERTIES55ITEM 3.LEGAL PROCEEDINGS55ITEM 4.MINE SAFETY DISCLOSURE55PART II56ITEM 5.MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDERMATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES56ITEM 6.RESERVED56ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTSOF OPERATIONS57ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK66ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA67ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING ANDFINANCIAL DISCLOSURE98ITEM 9A.CONTROLS AND PROCEDURES98ITEM 9B.OTHER INFORMATION98ITEM 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS98PART III99ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE99ITEM 11.EXECUTIVE COMPENSATION99ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT ANDRELATED STOCKHOLDER MATTERS99ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTORINDEPENDENCE99ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES99PART IV100ITEM 1