SEATTLE and VANCOUVER, British Columbia, July 29, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that the company will participate in the BTIG Virtual Biotechnology Conference being held July 29-30, 2025. Rick Stewart, Chief Executive Officer of Achieve, will participate in a fireside chat wit ...

Core Viewpoint - Achieve Life Sciences, Inc. has successfully closed a public offering of 15 million shares of common stock, raising gross proceeds of $45 million to advance the development of cytisinicline for nicotine dependence treatment [1][2]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence, with a New Drug Application submitted to the FDA in June 2025 [5]. - The company has completed two Phase 3 studies and an open-label safety study for cytisinicline, and has also conducted a Phase 2 study for vaping cessation [5]. 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 derived from nicotine products [7]. - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally, with over 8 million deaths annually [6]. - There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [6]. Financial Details - The public offering included 15 million shares at a price of $3.00 per share, along with warrants to purchase up to 16,766,666 additional shares [1]. - Proceeds from the offering will be used for advancing cytisinicline towards FDA marketing approval and for general corporate purposes [2].

Core Viewpoint - Achieve Life Sciences, Inc. is conducting a public offering of 15 million shares of common stock and accompanying warrants at a price of $3.00 per share, aiming to raise approximately $45 million to support the development of cytisinicline for nicotine dependence treatment [1][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence and smoking cessation [7]. - The company submitted a New Drug Application to the FDA for cytisinicline in June 2025, based on successful Phase 3 studies and an open-label safety study [7]. Offering Details - The public offering includes 15 million shares and warrants, with an additional 2.25 million shares available for underwriters to purchase [1][3]. - Each common warrant can be exercised for common stock at $3.00 or for pre-funded warrants at $2.999, expiring five years from issuance [2]. Financial Aspects - The gross proceeds from the offering are expected to be around $45 million, which will be used for advancing cytisinicline towards FDA approval and for general corporate purposes [4]. - The offering is expected to close around June 30, 2025, pending customary closing conditions [3]. Market Context - There are approximately 29 million adult smokers in the U.S., with tobacco use being the leading cause of preventable death [8]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the need for effective treatments for nicotine e-cigarette cessation, as there are currently no FDA-approved options for this indication [9].

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 [5] - 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 [5] Offering Details - Achieve Life Sciences announced a proposed underwritten public offering to sell shares of its common stock and accompanying common warrants, with an option for underwriters to purchase an additional 15% of the shares [1][2] - The proceeds from the offering are intended to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital and general corporate purposes [2] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over eight million deaths globally and nearly half a million in the U.S. annually [6] - There are around 17 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 for effective solutions [7] 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 [8][9] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the urgent need for treatments for nicotine dependence [7]

Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) to the FDA for cytisinicline, marking the first new pharmacotherapy option for nicotine dependence in two decades [1][4] - Cytisinicline has shown efficacy and safety in two large Phase 3 trials, ORCA-2 and ORCA-3, demonstrating significantly higher abstinence rates compared to placebo [2][3] - The public health burden of smoking affects nearly 29 million adults in the U.S., with smoking-related illnesses causing nearly half a million deaths annually [2][5] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment [4] - The company has also completed a Phase 2 study for vaping cessation and has received Breakthrough Therapy designation from the FDA for cytisinicline [6][4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, potentially reducing nicotine cravings and satisfaction from nicotine products [7] - The NDA submission is supported by data from over 2,000 clinical trial participants, indicating a well-tolerated safety profile [1][2]

Core Insights - Achieve Life Sciences is presenting additional analyses from its Phase 3 ORCA-3 study on cytisinicline at the 2025 ATS International Conference, emphasizing its dual mechanism of action in treating nicotine dependence [1][8] - Cytisinicline has shown significant efficacy in reducing nicotine cravings and intake, even among smokers who do not completely quit, indicating its potential as a therapeutic option for smoking cessation [3][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation, having completed two Phase 3 studies and one Phase 2 study for vaping cessation [7] - The company plans to submit a New Drug Application for cytisinicline in June 2025, aiming to address the smoking health epidemic affecting millions [6][7] Clinical Findings - The ORCA-3 study demonstrated a significant reduction in craving scores (p=0.0001) and serum cotinine levels among participants treated with cytisinicline compared to placebo, with a reduction equivalent to nearly four times more in cotinine levels [4][5] - Cytisinicline's dual action as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor may help smokers reduce their nicotine intake while on the path to quitting [3][5] Market Context - There are approximately 29 million adult smokers in the U.S., with smoking being the leading cause of preventable death, highlighting the critical need for effective cessation treatments [9] - Cytisinicline has received Breakthrough Therapy designation from the FDA, indicating its potential to address the urgent need for effective nicotine cessation therapies [10][11]