Achieve Life Sciences Reports Second Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program

Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) for cytisinicline to the FDA, marking a significant milestone in the development of a new treatment for nicotine dependence [4][12] - The company has established a partnership with Omnicom to create a data-driven commercialization strategy for the potential launch of cytisinicline in the U.S. [5] - Achieve completed a public offering raising $49.3 million to support the advancement of cytisinicline and general corporate purposes [6][7] Financial Performance - As of June 30, 2025, Achieve reported cash, cash equivalents, and marketable securities totaling $55.4 million [10] - Total operating expenses for the second quarter of 2025 were $12.6 million, with a net loss of $12.7 million for the quarter [10][19] - The company raised gross proceeds of $45 million from an underwritten public offering, which included 15 million shares of common stock and accompanying warrants [6] Clinical Development - The NDA submission is supported by positive results from Phase 3 ORCA-2 and ORCA-3 trials, which demonstrated significantly higher quit rates with cytisinicline compared to placebo [4] - Achieve has met the FDA's long-term safety requirements for cytisinicline, with over 300 participants completing at least six months of treatment [8] - The Phase 3 ORCA-3 trial results were published in JAMA Internal Medicine, confirming the efficacy and tolerability of cytisinicline for smoking cessation [9] Market Opportunity - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, with smoking being the leading cause of preventable death [13] - Cytisinicline has the potential to address a critical unmet public health need, especially given the nearly half a million smoking-related deaths annually in the U.S. [4][13] - The partnership with Omnicom aims to leverage a unified, AI-enabled launch platform to optimize the commercialization process for cytisinicline [5]