Q1 net loss $12.8M; on track for cytisinicline NDA submission to FDA in June 2025

ACHIEVE LIFE SCIENCES, INC.

2025-Q1 EPS reported -$0.37

Cash, equivalents, and marketable securities totaled $23.2M; operating expenses $12.9M for Q1 2025.
Plans to submit NDA for cytisinicline to FDA in June 2025; ORCA-3 results published in JAMA Internal Medicine.
ORCA-OL long-term safety trial met FDA requirements: >300 patients with 6 months, >100 with 1 year treatment.
DSMC third safety review found no concerns; SAB meeting held in May 2025 with ten nicotine cessation experts.

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