ACHIEVE LIFE SCIENCES, INC.

e

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED June 30,2026

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM ______________ TO ____________.

Commission file number 033-80623

(Exact Name of Registrant as Specified in Its Charter)

22722 29th Drive SE, Suite 100, Bothell, WA 98021

1040 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)

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 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 Rule 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 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 an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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 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 August 11, 2026 there were 102,902,490 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

Index to Form 10-Q

INFORMATION REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties. We caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement. These statements are based on current expectations of future events. We operate in a competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual 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 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 by looking for words like “believes,” “expects,” “anticipates,” “estimates,” “may,” “should,” “will,” “could,” “plan,” “intend” or similar expressions in this Quarterly Report on Form 10-Q or in documents incorporated by reference into this Quarterly Report on Form 10-Q. Examples of these forward-looking statements include, but are not limited to:

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anticipated regulatory filings and U.S. Food and Drug Administration, or FDA, responses, recommendations, requirements or additional future clinical trials;

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anticipated timing and success of our New Drug Application, or NDA, resubmission following the Complete Response Letter, or CRL, from the FDA;

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the potential benefits and differentiated profile, FDA approval, commercialization and commercial market for cytisinicline;

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the ability of our third-party manufacturers to receive and maintain FDA approval, and provide sufficient supply of cytisinicline in a timely manner;

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progress and preliminary and future results of any clinical trials;

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timing and plans for the expansion of our focus to develop cytisinicline for additional methods of nicotine dependence beyond the initial proposed indication of smoking, including vaping;

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market acceptance, the estimated revenue of our product and the estimated potential size of these markets;

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our ability to raise additional capital as needed to fund our planned development and commercialization efforts and service our existing debt;

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timing and amount of future contractual payments, product revenue and operating expenses; and

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our expectations regarding the impact of the macroeconomic and geopolitical environment, including fluctuating inflation, interest and tariff rates, the impact of significant political, trade and regulatory developments, potential shutdowns of the U.S. government, increased volatility in the debt and equity markets, instability in the global banking system, global health crises and pandemics and geopolitical conflict, and their potentially material adverse impact on our business and the execution of our preclinical studies and clinical trials.

These forward-looking statements are based on the current beliefs and expectations of our management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results may differ materially from current expectations and projections. Factors that might cause such a difference include those discussed in Item 1A “Risk Factors,” as well as those discussed elsewhere in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q or, in the case of documents referred to or incorporated by reference, the date of those documents.

All written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We do not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events, except as may be required under applicable U.S. securities law. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

Summary of Risk Factors

An investment in our common stock involves various risks, and prospective investors are urged to carefully consider the matters discussed in the section titled “Risk Factors” prior to making an investment in our common stock. These risks include, but are not limited to, the following:

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If we fail to obtain additional financing when needed, we may be unable to complete the development, regulatory approval and commercialization of our product candidate.

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We have incurred debt, which could impair our flexibility and access to capital and adversely affect our financial position, and our business would be materially adversely affected if we are unable to service our debt obligations.

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Cytisinicline is currently our sole product candidate and there is no guarantee that we will be able to successfully obtain approval from the U.S. Food and Drug Administration, or FDA, or other regulatory agencies to commercialize cytisinicline.

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Our planned NDA resubmission, following our receipt of a CRL citing deficiencies at a third-party manufacturing facility, may be delayed, may not adequately address the FDA's concerns, or may not result in approval on the timeline we expect or at all.

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The development and commercialization of our product candidate is dependent upon securing sufficient quantities of cytisinicline from plant sources, which grow outside of the United States in a limited number of locations.

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We expect to continue to rely on third parties to manufacture cytisinicline. Our commercialization of cytisinicline could be stopped, delayed or made less profitable if our manufacturing partners fail to obtain approval of government regulators, fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices.

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We are currently involved in a dispute with Sopharma AD, or Sopharma, relating to cytisinicline. If we and Sopharma are unable to resolve this dispute, or if the arbitration is resolved unfavorably to us, our rights with respect to the potential commercialization of cytisinicline could be delayed, restricted, or otherwise adversely affected, which could harm our ability to generate value from cytisinicline.

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The FDA may not grant marketing approval of cytisinicline without additional clinical or nonclinical studies, or at all.

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If we do not obtain the necessary regulatory approvals in the United States and/or other countries, we will not be able to sell cytisinicline.

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Cytisinicline may cause undesirable side effects or have other properties that could delay or prevent regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.

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It is difficult to evaluate our current business, predict our prospects and forecast our financial performance and growth.

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We face substantial competition, and our competitors may discover, develop or commercialize products faster or more successfully than us.