Achieve Life Sciences submits cytisinicline NDA to FDA; cash position $55.4M

ACHIEVE LIFE SCIENCES, INC.

NDA submitted to FDA in June 2025 for cytisinicline as smoking cessation treatment in adults.
Raised $49.3M gross from underwritten public offering in June-July 2025; expects runway into H2 2026.
Partnered with Omnicom for integrated launch strategy, reducing internal commercial buildout costs.
ORCA-OL safety requirements met: >300 subjects with ≥6 months, >100 with ≥1 year cumulative exposure.
Q2 2025 net loss $12.7M; operating expenses $12.6M; cash & securities $55.4M as of June 30.

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