SEATTLE, Wash and VANCOUVER, British Columbia, July 22, 2021 — 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 it has been awarded a grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use.

This initial grant award, to commence on August 1, 2021, will be utilized to complete critical regulatory and clinical operational activities, such as protocol finalization, clinical trial site identification, and submission of a new IND to FDA for investigating cytisinicline in nicotine e-cigarette users. Upon completion of these milestones, as assessed by NIH, Achieve expects to receive the next stage of the grant award that will enable initiation of the Phase 2 ORCA-V1 clinical study evaluating cytisinicline in approximately 150 adult nicotine e-cigarette users in the United States. The Primary Investigators for the grant are Achieve’s Chief Medical Officer, Dr. Cindy Jacobs, and Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital.

The use of e-cigarettes continues to be widespread, with most recent reports from the Centers for Disease Control and Prevention indicating that there were nearly 11 million adult users in the United States alone in 2019. While e-cigarettes have been historically viewed as less harmful than combus