Core Thesis - Achieve Life Sciences, Inc. (ACHV) is positioned for significant growth as it awaits FDA approval for cytisinicline, a non-nicotine therapy for smoking addiction, with a decision expected by June 20, 2026 [3] Company Overview - ACHV is a late-stage pharmaceutical company focused on developing and commercializing cytisinicline for nicotine independence in Canada, the U.S., and the U.K. [3] - The company has a market capitalization of approximately $250 million and aims to position cytisinicline as a best-in-class alternative to existing smoking cessation drugs [3] Product Efficacy and Safety - Cytisinicline has a long history of safe use in Europe and has shown strong efficacy and tolerability in the U.S., supported by two successful Phase 3 trials and a long-term safety study [4] - The treatment has not been associated with serious adverse events, enhancing its profile as a potential FDA-approved therapy [4] Market Opportunity - There are about 29 million smokers in the U.S., with over half attempting to quit each year, but fewer than 10% succeed, highlighting a significant unmet medical need for effective smoking cessation therapies [4] - ACHV is also pursuing approval for vaping cessation, where no FDA-approved therapies currently exist, and cytisinicline has received Breakthrough Therapy designation [5] Financial Position - As of Q3 2025, ACHV had $48 million in cash, providing sufficient runway through the FDA decision, although additional capital will likely be needed for commercialization [5] - If approved, cytisinicline could access a large, reimbursed market with limited competition, potentially leading to a significant re-rating of ACHV as it transitions to a commercial-stage company [5] Stock Performance - ACHV's stock price has appreciated approximately 56.55% since March 2025, driven by advancing FDA milestones and improving approval visibility [6]

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]