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 superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), demonstrating a 4.29% improvement in quit rates in favor of cytisinicline. Specifically, continuous abstinence rates at 6 months, verified by exhaled carbon monoxide, were 12.1% for cytisinicline compared to 7.9% for varenicline. The Relative Risk was 1.55 on an intent-to-treat basis, indicating that subjects in the cytisinicline arm were approximately one and a half times more likely to have quit smoking at 6 months compared to subjects who received varenicline.

Additionally, significantly fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001). Notably, of the subjects who experienced adverse events (111 in the cytisinicline arm compared to 138 in the varenicline arm), there was significantly less nausea (22.5% vs. 39.1%) and vivid dreams (7.2% vs. 17.4%) respectively.

“In this trial, subjects who received cytisinicline were on average 55% more likely to quit smoking and about half as likely to experience adverse events,” said Cindy Jacobs, Chief Medical Officer of Achieve. “Adverse events can often lead to poor compliance, discontinuation of treatment, and worse quit rates. The safety profile in RAUORA confirms what we have seen historically, that cytisinicline continues to demonstrate lower AEs, in particular, reduced nausea, which is the most commonly reported AE for varenicline.”

“It has been over a decade since the launch of Chantix and there still remain over 34 million smokers in the U.S. alone. New, effective treatments, such as cytisinicline, that offer improved tolerability are desperately needed to help the millions of people who are addicted to nicotine,” commented Richard Stewart, Chairman and Chief Executive Officer of Achieve. “Importantly, the benefits observed in the RAUORA study were achieved using a lower dose of cytisinicli