Achieve Life Sciences Inc. 2026年季度报告

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES FOR THE QUARTERLY PERIOD ENDED March 31, 2026or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIESEXCHANGE ACT OF 1934 Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware95-4343413(State or Other Jurisdiction of(I.R.S. EmployerIncorporation or Organization)Identification Number)22722 29th Drive SE, Suite 100, Bothell, WA 980211040 West Georgia Street, Suite 1030, Vancouver, British Columbia, Canada V6E 4H1(Address of Principal Executive Offices)(604) 210-2217(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: The NasdaqCapital Market LLC 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 ExchangeAct of 1934 during 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 requirements for 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 toRule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒ Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. As of May 12, 2026 there were 102,659,057 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding. Index to Form 10-Q Part I.Financial Information Item 1.Consolidated Financial Statements (unaudited)5Consolidated Balance Sheets as of March 31, 2026 (unaudited) and December 31, 20255Consolidated Statements of Loss and Comprehensive Loss (unaudited) for the three months ended March 31,2026 and March 31, 20256Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2026 and March 31,20257Consolidated Statements of Stockholders’ Equity (unaudited) for the three months ended March 31, 2026 andMarch 31, 20258Notes to Consolidated Financial Statements (unaudited)9Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations23Item 3.Quantitative and Qualitative Disclosures About Market Risk29Item 4.Controls and Procedures29 Part II.Other Information Item 1A.Risk Factors Item 6.Exhibits Items 1, 2, 3, 4 and 5 are not applicable and therefore have been omitted. Signatures INFORMATION REGARDING FORWARD LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities LitigationReform Act of 1995. These forward-looking statements involve a number of risks and uncertainties. We caution readers that anyforward-looking statement is not a guarantee of future performance and that actual results could differ materially from thosecontained in the forward-looking statement. These statements are based on current expectations of future events. We operate in acompetitive and rapidly changing environment, and new risks emerge from time to time. It is not possible to predict all risks, norcan we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may causeactual results to differ materially from those contained in any forward-looking statements we may make. Such statements include,but are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions, costs •anticipated regulatory filings and U.S. Food and Drug Administration, or FDA, responses, recommendations,requirements or additional future clinical trials;•the potential benefits and differentiated profile, FDA approval, commercialization and commercial market forcytisinicline;•the ability of our third-party manufacturers to receive and maintain FDA approval, and provide sufficient supply ofcytisinicline in a timely manner; These forward-looking statements are based on the current beliefs and expectations of our management and are subject tosignificant risks and uncertainties. If underlying assumptions prove