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Achieve Life Sciences announced that the Company has issued an inducement grant of stock options to a new employee. Achieve's Board of Directors approved the new employment inducement grant to purchase 25,000 shares of Achieve's common stock with the grant awarded on March 14, 2023. Achieve granted the stock options as a material inducement to the new employee for entering into an employment agreement with Achieve in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options approved under the inducement grant were issued pursuant to a stock option agreement on terms substantially similar to Achieve's 2018 Equity Incentive Plan and have a per share exercise equal to the closing price of Achieve's common stock on March 14, 2023. The stock options vest over four years, with 25% vesting on the first anniversary of the employee's start date and 1/36TH of the remaining shares vesting monthly thereafter, subject to the employee's continued employment on each such date. The stock options have a 10-year term and are subject to the terms and conditions of the stock option agreements.

Achieve Life Sciences announced that the last study follow-up visit for the last subject enrolled in the Phase 2 ORCA-V1 trial has occurred. "We are excited to have reached this important milestone in the ORCA-V1 trial, bringing us one step closer to understanding the cessation potential of cytisinicline in users of nicotine e-cigarettes who desire to quit," stated John Bencich, Chief Executive Officer of Achieve. "We look forward to reporting topline results in the second quarter of this year from both the ORCA-V1 trial, and separately from ORCA-3, our second Phase 3 trial in smoking cessation."

Achieve Life Sciences announced data from the Phase 3 ORCA-2 trial will be presented at the Society for Research on Nicotine and Tobacco Annual Meeting, being held in San Antonio, TX, March 1-4, 2023. Additional findings from the ORCA-2 trial, that evaluated cytisinicline as a treatment for smoking cessation, will be included in the "Novel Treatments for Smoking Cessation" session held today, March 3, 2023, at 3:15 p.m. CST. The presentation will be given by ORCA-2 Principal Investigator, Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital. Topline results from the ORCA-2 trial were reported in April 2022, demonstrating 6-8 times increased likelihood of smoking abstinence with 3mg cytisinicline dosed 3 times daily for a period of 6-weeks or 12-weeks compared to placebo in 810 adult U.S. smokers. The study population was approximately 52 years in age, smoked a pack of cigarettes a day, and had made 5 to 6 prior quit attempts. Additional analyses being reported confirm that successful abstinence was observed in subgroups of smokers who received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. Subjects who received either 6 or 12-weeks of cytisinicline treatment experienced consistently higher rates of abstinence. The improvement was observed by the second week of treatment, maintained weekly throughout study treatment and during the 24- week follow-up period, compared to those who received placebo. Study compliance was high with 82% of subjects completing the 12 weeks of treatment. No treatment-related serious adverse events were reported and the majority of adverse events were mild in all subjects. Achieve is currently conducting the final FDA-registration enabling Phase 3 ORCA-3 trial for smoking cessation and the Phase 2 ORCA-V1 trial evaluating cytisinicline for e-cigarette cessation. The Company continues to expect topline data results for both trials to be announced in the second quarter of 2023.