Topline data from ORCA-1 trial expected in the Second Quarter of 2019

SEATTLE, Wash. and VANCOUVER, British Columbia, April 2, 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 announced that the Data Safety Monitoring Committee (DSMC) met on March 28, 2019 to conduct its second and final safety review of the ORCA-1 Trial.

The DSMC is an independent committee that advises on continuation or stopping of clinical trials based upon safety and study conduct considerations. The ORCA-1 DSMC has had the responsibility for safeguarding the interests of trial subjects by assessing the safety of the interventions and monitoring the conduct of the ORCA-1 trial. The committee has reviewed the ORCA-1 data twice during the conduct of the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues, and the trial should continue for completion as planned. ORCA-1 topline efficacy and safety data are expected to be announced by end of the second quarter of 2019.

“We are very pleased with the speed of enrollment and efficient conduct of the ORCA-1 trial, which is attributed to the commitment of the trial subjects, clinical investigators and their support teams,” said Dr. Cindy Jacobs, Chief Medical Officer at Achieve. “We look forward to sharing the data results in the near future.”

ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other addiction indications. ORCA-1 was initiated in October 2018 and enrolled 254 smokers at eight centers across the United States.

The Phase 2b trial is evaluating a 25-day treatment course of 1.5 mg or 3.0 mg doses of cytisinicline using either a declining titration schedule or three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is the overall reduction in the number of cigarettes smoked during the treatment period, with secondary analyses being conducted on smoking cessation rates, safety, and compliance. Smokers who are participating in the trial receive standardized behavioral support.

Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.