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].

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]

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]

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence [3] - The company has successfully completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation [3] - Achieve plans to submit its new drug application for smoking cessation in Q2 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 with a high binding affinity to the nicotinic acetylcholine receptor, aimed at treating nicotine addiction for both smoking and e-cigarette cessation [6] - The product is believed to reduce the severity of nicotine craving symptoms and the reward associated with nicotine products [6] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the critical need for e-cigarette cessation treatments [5] Market Context - Approximately 29 million adults smoke combustible cigarettes in the U.S., with tobacco use being 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 1.6 million middle and high school students reporting e-cigarette use in 2024 [5] - Currently, there are no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation [5]

Core Viewpoint - Achieve Life Sciences is progressing towards the submission of a New Drug Application (NDA) for cytisinicline, a treatment for nicotine dependence, following a positive safety review from the Data Safety Monitoring Committee (DSMC) [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for smoking cessation and nicotine dependence [7][8] - The company has completed two Phase 3 clinical trials involving over 1,600 subjects who smoke cigarettes and wish to quit [5] Clinical Trial Details - The ORCA-OL trial is an open-label study evaluating the long-term exposure of a 3 mg cytisinicline treatment regimen, dosed three times daily, in adults aged 18 and older who want to quit smoking or vaping [6] - The trial has enrolled 479 participants across 29 clinical sites in the United States, with a significant milestone achieved as at least 300 participants completed six months of treatment [3][4] Safety Review Findings - The DSMC's second independent review found no unexpected treatment-related adverse events, confirming the overall safety profile of cytisinicline consistent with previous trials [2][3] - The study can continue as planned without modifications, reinforcing confidence in the cytisinicline safety profile [2][3] Regulatory Pathway - Achieve plans to submit the NDA in Q2 2025, which will be the first new prescription treatment for nicotine dependence in nearly 20 years [4] - The FDA requires six-month safety exposure data from at least 300 participants and one-year cumulative exposure data from a minimum of 100 participants for NDA approval [4][6] Market Context - Approximately 29 million adults smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally [9][10] - 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 [10][11]

Core Insights - Achieve Life Sciences, Inc. has appointed Kristen Slaoui, Ph.D., and Nancy Phelan to its Board of Directors, bringing extensive experience in corporate strategy and commercialization to support the development of cytisinicline for smoking cessation [1][2][3] Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline, a treatment for smoking cessation and nicotine dependence [4] - The company has completed two Phase 3 studies for cytisinicline in smoking cessation and one Phase 2 study for vaping cessation, with plans to submit a new drug application in Q2 2025 [5] Industry Context - 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 in the U.S. annually [6] - 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 [7] - Cytisinicline has been granted Breakthrough Therapy designation to address the urgent need for effective treatments in this area [7][8]

Core Insights - Achieve Life Sciences has reached a significant milestone in its ORCA-OL clinical trial, with over 300 participants completing six months of cumulative treatment with cytisinicline, which is essential for the New Drug Application (NDA) submission [2][3][4] - The FDA has requested six-month safety exposure data for the NDA, and no safety concerns have been identified during the ongoing review [2][3] - The planned NDA submission for cytisinicline is on track for Q2 2025, aiming to address nicotine dependence and smoking cessation [2][4] Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, having completed two Phase 3 trials involving over 1,600 subjects [6][4] - The company has received Breakthrough Therapy designation for cytisinicline, highlighting its potential to meet an urgent public health need [8][9] - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors to help reduce nicotine cravings and dependence [9] Clinical Trial Details - The ORCA-OL trial is an open-label study evaluating the long-term safety of a 3 mg cytisinicline regimen taken three times daily, conducted at 29 clinical sites across the U.S. [5][4] - The trial aims to provide safety data from at least 300 participants for the NDA submission, with additional data from at least 100 subjects treated for a cumulative one-year period to be submitted prior to potential product approval [5][4] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [7][8] - There are over 11 million adults in the U.S. who use e-cigarettes, and currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation [8][9]

Core Insights - Achieve Life Sciences, Inc. is focused on developing and commercializing cytisinicline for nicotine dependence, with significant milestones expected in 2025 [1][5]. Company Overview - Achieve Life Sciences is a late-stage pharmaceutical company dedicated to addressing nicotine addiction through cytisinicline [5]. - The company has completed two Phase 3 clinical trials involving over 1,600 subjects for smoking cessation and one Phase 2 trial for vaping cessation [3][5]. Clinical Development - Achieve plans to submit a New Drug Application (NDA) for cytisinicline as a smoking cessation aid in Q2 2025 [3][5]. - A single Phase 3 clinical trial for vaping cessation is expected to commence in Q3 2025 [3][5]. Market Context - Approximately 29 million adults smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally, accounting for over 8 million deaths annually [6]. - 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 [7]. Product Mechanism - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aiming to reduce nicotine cravings and the satisfaction derived from nicotine products [8].

Core Insights - Achieve Life Sciences has successfully completed its End-of-Phase 2 meeting with the FDA, marking a significant milestone for the development of cytisinicline as a potential first-in-class treatment for nicotine e-cigarette cessation [1][4][6] - The FDA has agreed on the proposed Phase 3 study design for cytisinicline, which includes a well-controlled trial (ORCA-V2) and the use of safety data from an ongoing study for label expansion [2][4] Company Overview - Achieve Life Sciences is focused on developing and commercializing cytisinicline to address nicotine dependence, particularly in the context of e-cigarette and vaping cessation [1][8] - The company has received Breakthrough Therapy designation from the FDA, which has facilitated expedited interactions and feedback during the clinical development process [4][8] Clinical Development - The Phase 3 ORCA-V2 trial is set to evaluate the efficacy and safety of 3 mg cytisinicline administered three times daily for 12 weeks in approximately 800 adults who use e-cigarettes [5][6] - The primary objective of the ORCA-V2 trial is to measure weekly vaping abstinence with biochemical confirmation during the last four weeks of treatment [5] Market Context - There are approximately 11 million adults in the U.S. who use e-cigarettes, with about 60% expressing a desire to quit, highlighting a significant unmet need for effective cessation treatments [3][8] - Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation, positioning cytisinicline as a potential solution in a growing public health challenge [3][8]

Company Overview - Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline for treating nicotine dependence [1][3] - The company is participating in two upcoming investor conferences: Jefferies London Healthcare Conference on November 19-21, 2024, and Piper Sandler 36th Annual Healthcare Conference on December 3-5, 2024 [2] Industry Context - Tobacco use is the leading cause of preventable death, responsible for over 8 million deaths globally and nearly 500,000 deaths annually in the United States [3] - Approximately 29 million adults smoke combustible cigarettes, and over 11 million adults in the U.S. use e-cigarettes [3][4] - In 2024, around 1.6 million middle and high school students in the U.S. reported using e-cigarettes [3] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors, aimed at treating nicotine addiction by reducing cravings and satisfaction associated with nicotine products [4] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the critical need for e-cigarette cessation treatments [3][4]