Achieve Life Sciences, Inc. filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission for the quarterly period ended June 30, 2026, with the filing dated August 11, 2026.

Key Highlights

  • Shares outstanding: As of August 11, 2026, there were 102,902,490 shares of common stock, $0.001 par value per share, outstanding.
  • Sole product candidate: Cytisinicline is disclosed as the company's only product candidate, according to the filing.
  • NDA resubmission pending: The company disclosed that its planned New Drug Application resubmission follows a Complete Response Letter from the FDA citing deficiencies at a third-party manufacturing facility.
  • Going concern risk: The filing notes that failure to obtain additional financing may leave the company unable to complete development, regulatory approval, and commercialization of its product candidate.
  • Filer status: The company is classified as a non-accelerated filer and a smaller reporting company.

Achieve Life Sciences Discloses NDA Resubmission Risks and Financial Dependence on Future Funding

Achieve Life Sciences, Inc. (NASDAQ:ACHV), a Delaware-incorporated company headquartered in Bothell, Washington, with offices also in Vancouver, British Columbia, Canada, filed its quarterly report for the period ended June 30, 2026. As of August 11, 2026, the company reported 102,902,490 shares of its common stock outstanding. The filing covers the three and six months ended June 30, 2026, and includes consolidated financial statements, management's discussion and analysis, and an updated risk factor section.

According to the filing, cytisinicline is the company's sole product candidate. The company disclosed that its planned NDA resubmission follows receipt of a Complete Response Letter from the FDA, which cited deficiencies at a third-party manufacturing facility. The filing states that the resubmission "may be delayed, may not adequately address the FDA's concerns, or may not result in approval on the timeline" anticipated. The company also noted that third-party manufacturers must receive and maintain FDA approval and provide sufficient supply of cytisinicline in a timely manner.

The filing identifies several key risk areas, including the company's need for additional financing to continue development and commercialization efforts, and its existing debt obligations. The company stated that it "has incurred debt, which could impair our flexibility and access to capital and adversely affect our financial position." Forward-looking statements in the filing are expressly qualified by the company's cautionary language and are subject to risks and uncertainties described in its Risk Factors section. The company noted it operates in a "competitive and rapidly changing environment" and does not undertake an obligation to update forward-looking statements except as required by applicable U.S. securities law.

What Was Disclosed

Achieve Life Sciences filed its Form 10-Q for Q2 2026 reporting 102,902,490 shares outstanding, ongoing NDA resubmission activities following an FDA Complete Response Letter, and risks related to financing needs and its sole product candidate, cytisinicline.