SEATTLE, Wash and VANCOUVER, British Columbia, November 12, 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 third quarter 2020 financial results and provided an update on the cytisinicline clinical development program.

Recent Events & Highlights

  • Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
  • Promoted John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President
  • Presented successful results from the RAUORA, head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix® (varenicline), at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting
  • Presented mechanism of action data comparing 5-HT3receptor activity of cytisinicline vs. Chantix at SRNT-E, providing rationale for differentiated side effect profile of smoking cessation treatments
  • Announced smoking cessation Key Opinion Leader Virtual Roundtable to be held on November 17, 2020

“With the initiation of the Phase 3 ORCA-2 trial and the breakthrough evidence, both mechanistically and clinically, in support of cytisinicline in comparison to Chantix, the third quarter of 2020 has undeniably been the most pivotal in the history of our company,” commented John Bencich, Chief Executive Officer of Achieve. “Our primary focus in the coming months will be enrollment and execution of ORCA-2, while continuing to explore opportunities for commercialization and expansion into new therapeutic indications, digital health technologies, and audiences who may benefit from cytisinicline, specifically, users of vapes or e-cigarettes.”

Phase 3 ORCA-2 Trial Initiation
Achieve’s first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo.  Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.

Management Team Update
In September, the Company announced the promotion of John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President. Mr. Bencich has been serving as Achieve’s Chief Financial and Operating Officer since 2017 and will join the Boa