ACHV
Achieve Life Sciences, Inc.4.3800
-0.1100-2.45%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
233.16MP/E (TTM)
-Basic EPS (TTM)
-1.35Dividend Yield
0%Recent Filings
10-Q
8-K
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.
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