Market Opportunity and Unmet Needs - Achieve Life Sciences has a unique opportunity to address a market of up to 50 million Americans who use tobacco with Cytisinicline[6] - Nicotine dependence is a public health crisis costing billions of dollars[6] and there are ~29 million US smokers with few treatment options[12] - Approximately 60% of adult e-cigarette users want to quit[14], with ~17 million US adults reporting e-cigarette use[16] - An estimated $11 Billion Rx opportunity exists in the market[46] Cytisinicline's Potential and Clinical Data - Cytisinicline is presented as the first potential new nicotine dependence treatment option in nearly 20 years[6, 18] - ORCA-2 and ORCA-3 trials showed strong results in smoking cessation, demonstrating efficacy, tolerability, and craving reduction[22] - In the 12-week Cytisinicline Treatment, the quit rate is 32.6% compared to 7% in the placebo group[23] - In the 6-week Cytisinicline Treatment, the quit rate is 25.3% compared to 4.4% in the placebo group[23] - Phase 2 ORCA-V1 trial showed a 2.6x (p=0.035) increased likelihood of quitting vaping with cytisinicline[39] Commercialization Strategy - The company anticipates filing a Smoking cessation NDA with launch expected in 2H26[6] - A focused launch strategy will leverage innovative, data-driven solutions to drive adoption and future growth[7] - The company will focus on high-volume prescribers and engaged quitters[48] - The company will target the varenicline market share, which peaked at ~2.8M Rx (75% in U S market - $800M)[51]

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 has successfully completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation, with plans to submit a new drug application in Q2 2025 [3][6] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults smoke combustible cigarettes in the U.S., with tobacco use being the leading cause of preventable death, responsible for over 8 million deaths globally and nearly half a million in the U.S. annually [4] - There are over 11 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [5] Upcoming Events - Achieve Life Sciences will present at the Barclays 27th Annual Global Healthcare Conference from March 11-13, 2025, with CEO Rick Stewart scheduled to present on March 12, 2025 [1][2]