Achieve DSMC finds no safety concerns in ORCA-OL; NDA on track for Q2 2025

ACHIEVE LIFE SCIENCES, INC.

DSMC completed second independent review of ORCA-OL trial; no unexpected treatment-related adverse events identified.
Participants' adherence to cytisinicline was excellent; study continues as planned without modifications.
Achieve reiterates planned New Drug Application submission for cytisinicline in Q2 2025.
ORCA-OL enrolled 479 participants across 29 US sites; 300+ completed six months of cumulative cytisinicline treatment.

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