SEATTLE, Wash. and VANCOUVER, British Columbia, October 24, 2019 — 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 that data from the Phase 2b ORCA-1 trial will be presented at the SRNT-O Inaugural Conference.

“Successful Smoking Abstinence with Cytisinicline in the ORCA-1 Trial: What Happens Next?” will be presented at the SRNT-O meeting by Achieve’s Chief Scientific Officer, Dr. Anthony Clarke, on Friday, October 25th in Sydney. The results of the ORCA-1 trial, to be discussed in the presentation, confirm that future Phase 3 clinical trials are expected to utilize 3.0 mg TID dosing of cytisinicline. The Company plans to extend dosing in the Phase 3 trials from 25 days to 42 days, or six weeks. The slightly longer dosing will allow for the primary endpoint of continuous abstinence over 4 weeks to be measured while subjects are still on treatment and potentially improve quit rates.

ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported earlier this year, demonstrated a 54% abstinence rate at week 4 in the 3.0 mg three times daily (TID) cytisinicline arm compared to 16% for placebo (p < 0.0001). Additionally for the 3.0 mg TID cytisinicline arm, a 4-week continuous abstinence rate, wee