Welcome to our dedicated page for Achieve Life Sciences SEC filings (Ticker: ACHV), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Achieve Life Sciences SEC filings document current reports on operating results, cytisinicline development updates, governance matters, material agreements, and capital-structure disclosures. Recent Form 8-K filings include furnished financial-results releases and business updates tied to the company’s late-stage specialty pharmaceutical focus on cytisinicline for nicotine dependence.
The filing record also covers executive and board changes, compensatory arrangements, consulting and separation agreements, shareholder voting matters, security-structure disclosures, and clinical or regulatory disclosures related to the cytisinicline program. These filings provide formal records of the company’s corporate events, financial-condition updates, and governance actions as a public biotechnology issuer.
ACHIEVE LIFE SCIENCES, INC. director Martin Christopher Nathan filed an initial Form 3 indicating that he currently holds no beneficial ownership of the company’s securities. The filing simply establishes his starting ownership position as a director, confirming zero shares reported as of this disclosure.
Achieve Life Sciences, Inc. registers up to 99,037,138 shares of Common Stock for resale by certain selling stockholders pursuant to a Purchase Agreement dated April 15, 2026. The registration covers (i) 49,418,069 Shares, (ii) 100,500 Pre-Funded Warrant Shares, and (iii) 49,518,569 Common Warrant Shares.
The prospectus clarifies that the company will not receive proceeds from resale transactions, but will receive cash proceeds if the Pre-Funded Warrants or Common Warrants are exercised for cash. Shares outstanding were 102,659,057 as of April 24, 2026, and the prospectus discloses beneficial ownership exercise limits of 4.99%, 9.99% or 19.99% (holder election, capped at 19.99%).
Achieve Life Sciences, Inc. registers up to 99,037,138 shares of Common Stock for resale by certain selling stockholders pursuant to a Purchase Agreement dated April 15, 2026. The registration covers (i) 49,418,069 Shares, (ii) 100,500 Pre-Funded Warrant Shares, and (iii) 49,518,569 Common Warrant Shares.
The prospectus clarifies that the company will not receive proceeds from resale transactions, but will receive cash proceeds if the Pre-Funded Warrants or Common Warrants are exercised for cash. Shares outstanding were 102,659,057 as of April 24, 2026, and the prospectus discloses beneficial ownership exercise limits of 4.99%, 9.99% or 19.99% (holder election, capped at 19.99%).
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 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 first quarter 2026 results and highlighted a large financing and leadership changes as it advances cytisinicline toward potential approval. Cash, cash equivalents and marketable securities were $29.3 million as of March 31, 2026, excluding estimated net proceeds of about $168.6 million from an April 2026 private placement that totals up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants.
Total operating expenses for the quarter were $10.5 million, resulting in a net loss of $10.2 million or $0.19 per share. The company’s New Drug Application for cytisinicline has a Prescription Drug User Fee Act date of June 20, 2026.
The board appointed Christopher Martin as a director, with a pro-rated $40,000 annual retainer and options for 47,250 shares vesting over three years. Chairman Thomas King will resign effective June 8, 2026, with Lucian Iancovici, MD, becoming Chair, and Chief Commercial Officer Jaime Xinos will depart effective May 31, 2026.
Achieve Life Sciences reported first quarter 2026 results and highlighted a large financing and leadership changes as it advances cytisinicline toward potential approval. Cash, cash equivalents and marketable securities were $29.3 million as of March 31, 2026, excluding estimated net proceeds of about $168.6 million from an April 2026 private placement that totals up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants.
Total operating expenses for the quarter were $10.5 million, resulting in a net loss of $10.2 million or $0.19 per share. The company’s New Drug Application for cytisinicline has a Prescription Drug User Fee Act date of June 20, 2026.
The board appointed Christopher Martin as a director, with a pro-rated $40,000 annual retainer and options for 47,250 shares vesting over three years. Chairman Thomas King will resign effective June 8, 2026, with Lucian Iancovici, MD, becoming Chair, and Chief Commercial Officer Jaime Xinos will depart effective May 31, 2026.
Franklin Resources, Inc. and affiliated filers reported beneficial ownership of 6,369,252 shares of Achieve Life Sciences, Inc. common stock, representing 6.2% of the class. The filing is an Amendment No. 5 to a Schedule 13G/A and lists Franklin Advisers, Inc. as holding sole voting and dispositive power over the 6,369,252 shares. The disclosure notes includes 2,000,000 shares issuable upon exercise of warrants and states the shares are held for investment management clients of Franklin's investment management subsidiaries.
Achieve Life Sciences, Inc. filed an amended annual report to update Part III for the year ended December 31, 2025, adding current information on directors, executive compensation, ownership and governance because its proxy will not be filed within 120 days.
The filing reports 102,659,057 common shares outstanding as of April 20, 2026 and an aggregate non‑affiliate market value of $103,958,994 as of June 30, 2025. It details a largely independent, highly credentialed board, a pay‑for‑performance philosophy with options and performance stock units tied to cytisinicline NDA milestones, cash bonuses paid at 75% of 2025 corporate targets, and severance and change‑of‑control protections for senior executives. The amendment also updates major shareholders, with several institutions each holding more than 5% of the common stock.
venBio Global Strategic Fund V and its general partner report a new position in Achieve Life Sciences, beneficially owning 10,737,317 shares of common stock, or about 9.99% of the company. This reflects both purchased shares and shares underlying warrants from a recent private placement.
In the private placement, Fund V bought 5,914,720 shares of common stock and 5,914,720 common warrants for a total of $21,500,007.20, using its working capital. The common warrants have a $3.51 exercise price and are subject to ownership caps that limit how much of Achieve’s stock venBio can hold at any time.
As part of the investment, venBio gained the right to designate one director to Achieve’s board and selected Aaron Royston, who was appointed to the board. Achieve also agreed to register for resale the shares and warrant shares held by the investors under a registration rights agreement.
Achieve Life Sciences, Inc. director Royston Aaron filed an initial Form 3 indicating that he currently has no securities beneficially owned in the company. The filing lists total shares following the reported holdings entry as 0.0000, so this is a position disclosure rather than a buy or sell transaction.
Achieve Life Sciences, Inc. filing: Paradigm BioCapital Advisors and related reporting persons state beneficial ownership totaling 9,903,712 shares, or 9.2%, of Common Stock as of 04/17/2026. The filing breaks this down into the Fund's and an Account's direct holdings and associated warrants.
The Fund beneficially owns 4,343,768 shares and 4,343,768 shares underlying warrants exercisable within 60 days. The Account beneficially owns 608,088 shares and 608,088 shares underlying warrants exercisable within 60 days. The filing bases percentages on 53,239,988 shares outstanding as of 03/24/2026, plus an additional 49,418,069 shares issued on 04/17/2026 and 4,951,856 shares underlying warrants disclosed in the statement.
TPG-affiliated entities report beneficial ownership of 13,755,160 Achieve Life Sciences common shares, representing 12.6% of the company’s outstanding stock. The position consists of 6,877,580 shares and 6,877,580 shares issuable upon exercise of 6,877,580 warrants at an exercise price of $3.51 per share.
Through TPG LSI Rise Auriga L.P., TPG agreed to purchase 6,877,580 shares and 6,877,580 accompanying warrants in a private placement at $3.635 per share‑and‑warrant combination, for an aggregate purchase price of $25,000,003.30. The warrants are exercisable after closing and remain outstanding until a period linked to potential FDA approval of cytisinicline for smoking cessation, with a 19.99% ownership cap on warrant exercise.
In connection with the investment, TPG Auriga obtained registration rights for resale of the purchased shares and the warrant shares, and its designee, Lucian Iancovici, was appointed to Achieve Life Sciences’ board of directors, with nomination rights for future annual meetings while TPG Auriga holds at least 5% of the outstanding common stock.