Subjects in the Cytisinicline Arm Were 55% More Likely to Quit Smoking at 6 Months Compared to Subjects Who Received Varenicline

Significantly Fewer Overall Adverse Events Were Reported in Cytisinicline-Treated Subjects (p<0.001)

Cytisinicline U.S. Phase 3 Trial Expected to Begin in Fourth Quarter 2020

SEATTLE, Wash and VANCOUVER, British Columbia, September 18, 2020 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced presentation of final results from the RAUORA trial, led by Dr. Natalie Walker, Associate Professor at the University of Auckland. RAUORA evaluated the effectiveness and safety of cytisinicline compared to varenicline as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family, (337 in the cytisinicline arm, 342 in the varenicline arm). Results were presented today at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting.

The primary endpoint of the non-inferiority trial was to demonstrate that cytisinicline quit rates would be no less than 10% lower than the quit rates for varenicline. Results showed that cytisinicline met the pre-specified non-inferiority endpoint and was trending towards superior