SEATTLE and VANCOUVER, British Columbia, Oct. 20, 2025 (GLOBE NEWSWIRE) --  Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced the appointment of Erik Atkisson as Chief Legal Officer. In his new role, Mr. Atkisson will oversee Achieve’s legal strategy, corporate governance, compliance, and risk management.

“Erik’s extensive legal, regulatory and M&A background in the biopharmaceutical sector provides valuable experience as we advance cytisinicline through regulatory review and prepare for a potential launch,” commented Rick Stewart, Chief Executive Officer of Achieve. “We are pleased to welcome Erik to our executive leadership team and are confident his expertise will greatly strengthen our work during this crucial growth period for Achieve.”

“I am honored to join Achieve during such a transformative time,” said Mr. Atkisson. “Nicotine dependence remains a significant public health challenge, and I am inspired by Achieve’s dedication to providing a new evidence-based treatment option to people who need it most. I look forward to supporting our team’s mission to address nicotine dependence as a medical condition and guiding the organization through the evolving regulatory landscape.”

Bringing over 25 years of experience in the pharmaceutical and biotechnology industries, Mr. Atkisson has held senior legal positions at multiple clinical- and commercial-stage biopharmaceutical companies. Mr. Atkisson recently served as General Counsel, Corporate Secretary, and Chief Compliance Officer at Rain Oncology, leading all legal matters including governance, IP, contracting, regulatory, privacy, and litigation. Earlier in his career, Mr. Atkisson served as General Counsel of Eiger BioPharmaceuticals and Chief Compliance Officer of Cytokinetics. He also held senior positions at Amneal Pharmaceuticals (formerly Impax Laboratories) and BioMarin Pharmaceutical. Mr. Atkisson holds a J.D. from Georgetown University Law Center, an M.Sc. from the University of Edinburgh, and a B.A. from Harvard University.

About Achieve Life Sciences, Inc.
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review.  The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026.  The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

About Cytisinicline
There are approximately 29 million adults in the United States who smoke combustible cigarettes.¹ Tobacco use is currently the leading cause of preventable death, responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually. 2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.³

In addition, there are approximately 17 million adults in the United States who use e-cigarettes, also known as vaping.⁴ In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.⁵ There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical unmet need.

Cytisinicline is a plant-derived alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine dependence for smoking cessation and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is a new investigational product candidate being developed for the treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to drive financial results and stockholder value, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including inflation, volatile interest rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Achieve Contact
Nicole Jones
Vice President, Strategic Communications and Stakeholder Relations
[email protected]
425-686-1510

References
¹VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
³U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
⁴Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025.
⁵Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.