Achieve Life Sciences Inc 2025年季度报告

EXCHANGE ACT OF 1934FOR THE QUARTERLY PERIOD ENDEDMarch 31,2025 orTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number033-80623Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of(I.R.S. EmployerIncorporation or Organization)Identification Number) 1040 West Georgia Street,Suite 1030,Vancouver,British Columbia,CanadaV6E 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:Title of each classTrading SymbolName of exchange on which registeredCommon Stock, par value $0.001 per shareACHVTheNasdaqCapital Market LLCIndicate 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 to “emerging growth company” in Rule 12b-2 of the Exchange Act.☐Accelerated filer Non-accelerated filer☒Smaller reporting companyEmerging growth company with 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☒ Notes to Consolidated Financial Statements (unaudited) Management’s Discussion and Analysis of Financial Condition and Results of OperationsControls and ProceduresPart II.Other InformationItem 1A.Risk FactorsExhibits 2 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 those include, but are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions,costs and expenses, interest rates, outcome of contingencies, financial condition, results of operations, liquidity, business strategies,cost savings, objectives of management and other statements that are not historical facts. You can find many of these statements bylooking for words like “believes,” “expects,” “anticipates,” “estimates,” “may,” “should,” “will,” “could,” “plan,” “intend” orsimilar expressions in this Quarterly Report on Form 10-Q or in documents incorporated by reference into this Quarterly Report on requirements or additional future clinical trials;•our ability to raise additional capital as needed to fund our planned development and commercialization efforts and repay our existing debt;•the potential benefits and differentiated profile, FDA approval, commercialization and commercial market for •the performance of, and our ability to obtain sufficient supply of cytisinicline in a timely manner from, third-partysuppliers and manufacturers; and geopolitical conflict, and their potentially material adverse impact on our business and the execution of ourpreclinical studies and clinical trials. 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 inaccurate or unknown risks or uncertainties materialize, actualresults may differ materially from current expectations and projections. Factors that might cause such a difference include those cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report All subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expresslyqualified in their entirety by the cautionary statements contained or referred to in this section. We do not undertake any obligation Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events, except as may be required under applicableU.S. securities law. If we do update one or more forward-looking statements, no inference should be drawn that we will makeadditional updates with respect to those or other forward-looking statements. An investment in our common stock involves various risks, and prospective investors are urged to carefully consider the mattersdiscussed in the section titled “Risk Factors” prior to making an investment in our common stock. These risks include, but are notlimited to, the following:•Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a go