SEATTLE, Wash and VANCOUVER, British Columbia, August 8, 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 second quarter 2019 financial results.

Q2 2019 Highlights

  • Reported positive results from the Phase 2b ORCA-1 dose-selection trial evaluating cytisinicline in 254 smokers. Cytisinicline demonstrated a statistically significant improvement in quit rates for a simplified 3.0 mg, three times daily dose. Cytisinicline was well-tolerated with no serious adverse events reported.
  • Announced ORCA-1 data has been accepted for an oral presentation at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference to be held in Oslo, Sept. 12-14, 2019
  • Patent granted in the U.S. for new cytisinicline succinate salt formulation designed to enhance product stability and long-term potency
  • Received $4.2 million in proceeds from exercise of warrants

“It has been an exciting quarter with the release of the positive ORCA-1 Phase 2b trial results that demonstrated impressive smoking cessation efficacy, safety, and cytisinicline treatment adherence,” commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. “The data exceeded our expectations and provide a clear path forward for our future Phase 3 program.”

ORCA-1 Positive Study Results
The Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers demonstrated a statistically significant improvement in quit rates for the 3.0 mg, three times daily dosing (TID) schedule. In the 3.0 mg TID arm, a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) was observed. Continuous abstinence at weeks 5 through 8 was 30% for cytisinicline compared to 8% for placebo (p= 0.005). Adherence to study treatment was 98% in the 3.0 mg TID arm and cytisinicline was well-tolerated with no serious adverse events reported.

Cytisinicline Data Accepted for Presentation
Data from the Phase 2b ORCA-1 trial has been accepted for oral presentation at the SRNT-E Annual Conference, to be held in Oslo, September 12-1