SEATTLE, Wash and VANCOUVER, British Columbia, March 14, 2019 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today provided an update on the cytisinicline clinical development program and announced fourth quarter and year-end 2018 financial results.

Recent Highlights

  • Completion of enrollment in 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers
  • Presented final data from cytisinicline Phase 1/2 multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) study at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting
  • Initiated a trial to assess the maximum tolerated dose, or MTD, for a single administered oral dose of cytisinicline
  • Pediatric waiver agreed by the S. Food and Drug Administration (FDA)
  • Closed registered direct offering for gross proceeds of $5.6 million

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, “The cytisinicline development program continues to advance rapidly and we are well-poised for continued success in 2019. As demonstrated by the swift enrollment in our Phase 2b trial, new treatments are desperately needed to help the millions of people who desire to quit smoking.”

ORCA-1 Phase 2b Trial Fully Enrolled
In February, Achieve announced completion of enrollment of 254 smokers in a Phase 2b trial evaluating cytisinicline in both the 1.5 mg and 3.0 mg doses on a declining titration schedule as well as three times dai