Achieve Life Sciences Q3 net loss $12.5M; ORCA-OL enrollment complete, NDA on track for Q2 2025

ACHIEVE LIFE SCIENCES, INC.

2024-Q3 EPS reported -$0.88

Cash, equivalents and investments $42.9M as of Sep 30, 2024; operating expenses $12.5M for Q3.
Completed enrollment in Phase 3 ORCA-OL trial with 479 participants across 29 U.S. sites.
FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette (vaping) cessation.
Leadership: Richard Stewart named CEO, Thomas King Executive Chairman, Jaime Xinos Chief Commercial Officer.
Planned NDA submission in Q2 2025; Data Safety Monitoring Committee found no safety concerns.

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