Every 10-Q that Achieve Life Sciences, Inc. (ACHV) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-Q covers the quarterly report filed between annual reports, so if you follow ACHV and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ACHV filings page.
Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence. For the three and six months ended June 30, 2026, it reported net losses of $74.8 million and $84.9 million, compared with $12.7 million and $25.5 million in the prior-year periods. The sharp increase was mainly driven by a non-cash $48.5 million loss from the change in fair value of newly issued warrant liabilities and $8.8 million of warrant issuance costs, along with higher general and administrative expenses and stock-based compensation.
Cash, cash equivalents and marketable securities rose to $187.3 million as of June 30, 2026 from $36.4 million at December 31, 2025, primarily reflecting a $168.2 million April 2026 private placement. Despite this, stockholders’ equity turned negative at $(14.7) million, largely due to recognizing a $182.7 million warrant liability. The company has an accumulated deficit of $345.2 million, no product revenue, and remains dependent on external financing, but management believes existing resources are sufficient to meet obligations for at least the next 12 months. Key risks include obtaining FDA approval for cytisinicline, reliance on third-party manufacturing and plant-derived supply, and an ongoing arbitration with Sopharma over supply arrangements.
Achieve Life Sciences reported a Q1 2026 net loss of $10.2M, narrower than the $12.8M loss a year earlier, as research and development spending declined after completing the ORCA-OL trial. Research and development expenses were $3.3M versus $7.1M in Q1 2025, while general and administrative costs rose to $7.2M from $5.8M on launch preparation and higher headcount.
At March 31, 2026, Achieve held $29.3M in cash, cash equivalents and marketable securities and positive working capital of $19.2M, against $15.0M of convertible debt. Liquidity strengthened significantly after quarter-end with an April 2026 private placement providing gross proceeds of about $180.0M (estimated net $168.6M).
The company develops cytisinicline for nicotine dependence and has an NDA under FDA review for smoking cessation with a PDUFA date of June 20, 2026. A third-party manufacturer received an FDA warning letter unrelated to cytisinicline, and Achieve expects a Complete Response Letter, plans to resubmit the NDA in Q4 2026 naming new partner Adare as manufacturer, and is targeting a U.S. commercial launch in the first half of 2027.
Achieve Life Sciences reported Q3 results marked by higher losses and added liquidity. Net loss was $14.4 million for the quarter and $40.0 million for the nine months ended September 30, 2025, driven by R&D of cytisinicline and rising G&A. Cash, cash equivalents, and marketable securities totaled $48.1 million as of September 30, 2025, up from $34.4 million at year-end, reflecting mid‑year financing.
Total assets were $52.0 million and stockholders’ equity was $33.6 million. Operating cash use was $31.5 million year‑to‑date. The company completed a June 2025 public offering of 15,000,000 shares and accompanying warrants, providing $41.2 million in net proceeds, with an additional $4.0 million from partial overallotment exercises. Convertible debt outstanding carried principal of $10.0 million at quarter‑end, with a subsequent $5.0 million tranche drawn in October 2025. Management disclosed substantial doubt about continuing as a going concern absent additional financing. Shares outstanding were 53,233,988 as of November 6, 2025.