Cytisinicline

New Directors Bring Extensive Leadership Experience in Corporate Strategy and Commercialization SEATTLE and VANCOUVER, British Columbia, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Kristen Slaoui, Ph.D., and Nancy Phelan will join its Board of Directors. Achieve also announced that current Board member, Vaughn Himes, Ph.D., has retired and resigned from the Board. He will continue to provide consulting services to the company. “We are delighted to welcome Kristen and Nancy to our Board of Directors,” said Tom King, Executive Chairman of Achieve’s Board of Directors. “Their wealth of knowledge and experience in strategic transactions, product commercialization and healthcare innovation will be instrumental as we approach the first NDA submission for cytisinicline for smoking cessation. Additionally, I want to express my gratitude to Vaughn for his years of dedication to Achieve and contributions to our progress.” Kristen B. Slaoui, Ph.D., has served as the Chief Corporate Development Officer at Galderma, a leading global dermatology company, since 2020, and serves on the board of directors of Kinaset Therapeutics and the board of advisors of Advancing Innovation in Dermatology, Inc. In her current role, she led a number of significant transactions, including the 2021 acquisition of Alastin Skincare. Prior to joining Galderma, Dr. Slaoui spent 20 years at GSK, contributing to groundbreaking pulmonary disease research and the development of several approved medicines, and held various roles of increasing seniority in Business Development teams, executing over $30 billion in deals, including major acquisitions like Stiefel Laboratories and Tesaro. Dr. Slaoui holds a B.S. in biology and classical studies from Gettysburg College, a Ph.D. in physiology from The Johns Hopkins University Bloomberg School of Public Health and completed a post-doctoral fellowship in pharmacology at the University of Washington School of Medicine. “Joining the Board of Achieve is an extraordinary opportunity to contribute to a company addressing one of the world’s most urgent health challenges,” stated Dr. Slaoui. “With my broad experience in corporate strategy and development, I am excited to support Achieve in its efforts to address the global smoking and nicotine dependence epidemic and deliver lasting impact for both patients and investors.” Nancy R. Phelan brings over 25 years of executive leadership in the biopharma and service industries. Currently, Nancy serves as Senior Vice President at Trinity Life Sciences and on the boards of directors of Medexus Pharmaceuticals and FemmePharma. In her current role at Trinity Life Sciences, Nancy has launched and heads a new Center of Excellence dedicated to data and analytics driven digital transformation and innovative customer engagement solutions with a focus on cutting-edge technology and AI. Nancy’s extensive pharmaceutical business model transformation and customer engagement commercialization expertise spans prescription and over-the-counter drugs. Prior to Trinity Life Sciences, Nancy was a Senior Vice President, Omnichannel Activation at Indegene and also held leadership roles at global pharmaceutical companies Novartis, Bristol Myers Squibb, and Pfizer. Throughout her career, Nancy has spearheaded new commercialization strategies and numerous launches resulting in significant revenue growth and market expansion. She has received many industry awards including MM+M Woman of Distinction, DTC Hall of Fame, PM 360 ELITE Digital Crusader, Working Mother Cover Mom and Pharmaceutical Executive 40 under 40. Ms. Phelan holds a B.A. with Honors in history from Franklin & Marshall College. “I’m very excited to join the Board at such an important time for the company and for cytisinicline's development,” said Ms. Phelan. “Achieve’s mission to combat nicotine dependence resonates with me personally, and I’m excited to contribute to its success. By leveraging my expertise in data-driven insights, digital innovation and digital-first marketing, I look forward to working with the company on optimizing commercialization strategies, driving efficiency and unlocking new growth opportunities, while staying ahead in a rapidly evolving market.” About Achieve Life Sciences, Inc. Achieve Life Sciences is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in Q2 2025. Achieve has conducted a successful end-of-Phase 2 meeting with the FDA for the vaping indication and expects to initiate its single Phase 3 clinical study in vaping later in 2025. About Cytisinicline There are approximately 29 million adults who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is 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 over 11 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 to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking 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 an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration 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, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, 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 and vaping cessation landscapes 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. Achieve Contact Nicole Jones ir@achievelifesciences.com 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. 4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 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 Released January 10, 2025