Achieve Life Sciences, Inc.
4.9500+0.17 (+3.56%)
Oct 29, 4:00:01 PM EDT · NasdaqCM · ACHV · USD
Key Stats
Market Cap
252.97MP/E (TTM)
-Basic EPS (TTM)
-1.48Dividend Yield
0%Recent Filings
8-K
CMO Jacobs resigns, consulting planned
Achieve Life Sciences' Chief Medical Officer and President, Dr. Cindy Jacobs, resigned effective October 6, 2025, after informing the board on September 5. The company is negotiating a consulting agreement to retain her advisory services. This shift maintains continuity in medical leadership amid ongoing operations.
8-K
NDA submitted for cytisinicline
Achieve Life Sciences submitted its NDA for cytisinicline to the FDA in June 2025, backed by Phase 3 trials showing superior quit rates over placebo and long-term safety data from over 300 participants. The company partnered with Omnicom for a streamlined U.S. launch and raised $49.3 million via public offering to fund advancement. Cash stood at $55.4 million as of June 30, 2025, supporting runway into late 2026. Yet regulatory approval remains uncertain.
10-Q
Q2 FY2025 results
Achieve Life Sciences posted a Q2 net loss of $12.7M, up 50% y/y from $8.5M, driven by R&D expenses climbing to $6.7M (31% y/y rise) for the ORCA-OL safety trial and G&A hitting $5.9M (77% y/y jump) amid launch prep and stock comp. YTD through June 30, 2025, losses widened to $25.5M from $15.0M last year, with operating expenses doubling to $25.5M on cytisinicline NDA submission in June. Diluted EPS fell to $(0.37) from $(0.25) y/y, confirmed against 34.7M weighted shares—no anti-dilution flagged. Cash swelled to $51.9M from a $41.2M public offering, plus $3.5M marketable securities, funding ops into H2 2026; $10M convertible debt matures 2027 at ~7% interest, secured sans IP. Sopharma supply dispute persists, with third-party makers now in the NDA. Yet cash burn eased q/q. FDA approval remains uncertain amid competition.
8-K
Priced $45M offering for FDA push
Achieve Life Sciences priced a $45 million public offering on June 26, 2025, selling 15 million shares and accompanying warrants at $3.00 each, with underwriters Citizens JMP and Raymond James granted a 30-day option for 2.25 million more. Net proceeds of $41.3 million will fund cytisinicline's push toward FDA approval and general purposes, bolstering the late-stage pharma's runway post-NDA submission. Warrants expire in five years, capped at 9.99% ownership. Closing hinges on customary conditions.
8-K
Annual meeting elects directors, rejects plan
Achieve Life Sciences held its annual stockholder meeting on June 4, 2025, electing seven directors—Stuart Duty, Bridget Martell, Thomas B. King, Thomas Sellig, Richard Stewart, Nancy R. Phelan, and Kristen Slaoui—to its board amid strong support, with votes for ranging from 12.96 million to 14.86 million shares. Shareholders ratified PricewaterhouseCoopers LLP as auditors for the fiscal year ending December 31, 2025, with 26.46 million votes in favor. Yet the amendment to boost shares in the 2023 Non-Employee Director Equity Incentive Plan failed, drawing 7.98 million against votes. This rejection signals investor caution on equity dilution.
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