Achieve Life Sciences to Participate in the BTIG Virtual Biotechnology Conference

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [3] - The company submitted its New Drug Application to the FDA for cytisinicline in June 2025, based on two completed Phase 3 studies and a fully enrolled open-label safety study [3] - Achieve has also completed a Phase 2 study for cytisinicline in vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Industry Context - Approximately 29 million adults in the United States smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over 8 million deaths worldwide and nearly 500,000 deaths annually in the U.S. [4] - More than 87% of lung cancer deaths, 61% of pulmonary disease deaths, and 32% of coronary heart disease deaths are attributable to smoking and secondhand smoke exposure [4] - There are around 17 million adults in the U.S. who use e-cigarettes, with 1.6 million middle and high school students reporting e-cigarette use in 2024 [4] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors, believed to aid in treating nicotine addiction by reducing craving symptoms and the satisfaction associated with nicotine products [5] - Cytisinicline is currently an investigational product candidate and has not yet been approved by the FDA for any indication in the United States [5] - The FDA has granted Breakthrough Therapy designation to cytisinicline to address the critical need for treatments specifically aimed at nicotine e-cigarette cessation [4]