Achieve Life Sciences Announces Changes in Executive Leadership and Board of Directors

Leadership Changes - Richard Stewart reassumes the role of Chief Executive Officer, replacing John Bencich who will serve as an advisor during the transition [1] - Thomas King is appointed as the Executive Chairman of the Board of Directors [1] - The leadership change is driven by the need for a CEO with substantial M&A and commercial experience to push the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline [2] Company Objectives and Progress - The company remains on track to meet its objectives for the year, including completing enrollment for the ORCA-OL study, meeting with the FDA for the End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation, and progressing towards the NDA submission expected in the first half of 2025 [2] - The company aims to bring forward a potentially life-changing treatment for nicotine dependence while optimizing shareholder value [2] Industry Context and Market Opportunity - Approximately 29 million adults in the United States smoke combustible cigarettes, contributing to over eight million deaths worldwide annually, with smoking being the leading cause of preventable death [3] - Over 11 million adults in the United States use e-cigarettes, and approximately 2.1 million middle and high school students reported using e-cigarettes in 2023 [3] - There are currently no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation, highlighting a significant unmet medical need [3] Product Overview - Cytisinicline is a plant-based alkaloid with high binding affinity to the nicotinic acetylcholine receptor, believed to aid in treating nicotine addiction by reducing withdrawal symptoms and the reward associated with nicotine products [4] - Cytisinicline is an investigational product candidate for nicotine addiction treatment and has not yet received FDA approval [4]