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Achieve Life Sciences Reports Second Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program
GlobeNewswire News Room· 2025-08-07 11:30
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]
Achieve Life Sciences to Announce Second Quarter Financial Results and Host Conference Call and Webcast on August 7, 2025
Globenewswire· 2025-07-24 12:30
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 vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide annually [4] - There are about 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 that cytisinicline aims to address [5] Market Context - The smoking and vaping cessation market is significant, with a large population of nicotine-dependent individuals and a lack of effective treatments currently available [5] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA, indicating its potential importance in addressing nicotine dependence [5] - The company is positioned to capitalize on the growing awareness and need for effective smoking cessation therapies as public health initiatives continue to combat tobacco use [4][5]
Achieve Life Sciences to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 12:30
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 and one Phase 2 study related to cytisinicline for smoking and vaping cessation [3] - Achieve plans to submit its new drug application for smoking cessation in June 2025 and has conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide 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 - Rick Stewart, CEO of Achieve, will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 5:30 PM EDT, with a live webcast available on the company's Investor Relations website [2]
Achieve Life Sciences to Announce First Quarter 2025 Financial Results and Host Conference Call and Webcast on May 13, 2025
GlobeNewswire News Room· 2025-05-06 12:30
Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence and smoking cessation [3] - The company has completed two Phase 3 studies and one Phase 2 study related to cytisinicline, with plans to submit a new drug application in June 2025 [3] 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 [5] - The product has received Breakthrough Therapy designation from the FDA, highlighting its potential to address the significant need for effective smoking and vaping cessation treatments [4][5] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [4] - There are over 11 million adults in the U.S. who use e-cigarettes, and no FDA-approved treatments specifically for e-cigarette cessation currently exist [4] Upcoming Events - Achieve Life Sciences will report its first quarter 2025 financial results and provide updates on the cytisinicline development program on May 13, 2025, at 8:30 AM EDT [1]
Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2024 and Provides Update on the Cytisinicline Development Program
Globenewswire· 2025-03-11 11:30
Core Viewpoint - Achieve Life Sciences is on track to submit its new drug application (NDA) for cytisinicline, a treatment for nicotine dependence, by the end of Q2 2025, following significant progress in clinical trials and corporate governance [1][3][4]. Company Developments - The company has completed enrollment in the ORCA-OL clinical trial with 479 participants across 29 U.S. sites, focusing on the long-term safety of a 3 mg cytisinicline regimen for smoking and vaping cessation [4]. - Achieve received two positive reviews from the Data Safety Monitoring Committee (DSMC) for the ORCA-OL trial, confirming no unexpected treatment-related adverse events and excellent participant adherence [5]. - The company appointed Dr. Kristen Slaoui and Nancy Phelan to its Board of Directors, enhancing its expertise in corporate strategy and commercialization [6]. - Mark Oki was appointed as Chief Financial Officer in December 2024, bringing over 25 years of experience in financial leadership within the biotechnology and pharmaceutical sectors [7]. Clinical Trial Progress - The ORCA-OL trial met the requirement of at least 300 participants completing six months of treatment, which is essential for the NDA submission [4][8]. - An End-of-Phase 2 meeting with the FDA confirmed that one well-controlled Phase 3 trial (ORCA-V2) would be sufficient for a vaping cessation indication, with plans to initiate this trial in the first half of 2026, depending on funding availability [9]. Financial Overview - As of December 31, 2024, Achieve reported cash, cash equivalents, and marketable securities totaling $34.4 million, with total operating expenses of $39.1 million for the year [10][20]. - The net loss for the fourth quarter and the year ended December 31, 2024, was $12.4 million and $39.8 million, respectively, with a basic and diluted net loss per share of $0.36 and $1.24 [10][20]. Market Context - There are approximately 29 million adults who smoke combustible cigarettes in the U.S., with tobacco use being the leading cause of preventable death [13]. - Over 11 million adults in the U.S. use e-cigarettes, highlighting a significant market opportunity for cytisinicline, which has received Breakthrough Therapy designation from the FDA for vaping cessation [14][15].
Achieve Life Sciences to Announce Fourth Quarter and Year-End 2024 Financial Results and Host Conference Call and Webcast on March 11, 2025
Globenewswire· 2025-03-06 13:30
Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence and smoking cessation [3] - The company has 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] 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, with tobacco use being the leading cause of preventable death, resulting in over 8 million deaths globally and nearly 500,000 deaths annually in the U.S. [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 for cytisinicline [5] Upcoming Events - Achieve Life Sciences will report its fourth quarter and year-end 2024 financial results and provide an update on the cytisinicline development program on March 11, 2025, at 8:30 AM EDT [1]