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]

Financial Data and Key Metrics - The company's cash, cash equivalents, restricted cash, and short-term investments were $42.9 million as of September 30, 2024, compared to $61.3 million in the prior quarter [45] - Net loss for Q3 2024 was $12.5 million, compared to a net loss of $7.1 million in the same quarter of the prior year [46] - Net loss for the nine months ended September 30, 2024, increased to $27.5 million from $24.3 million in the same period in 2023 [46] - Operating expenses increased in Q3 due to the targeted enrollment in the ORCA-OL trial, with expectations of elevated expenses as the trial progresses [47] Business Line Data and Key Metrics - The ORCA-OL open-label safety trial for long-term cytisinicline exposure completed enrollment with 479 participants across 29 trial sites in the U.S. [19] - The trial aims to meet FDA requirements for safety data on at least 300 subjects treated with cytisinicline for six months and 100 subjects for one year [20] - The Data Safety Monitoring Committee reported no safety concerns, allowing the study to continue without modifications [21] Market Data and Key Metrics - The target population for nicotine dependence treatment includes over 40 million Americans and more than 1 billion people globally [10] - Approximately 29 million Americans smoke combustible cigarettes, and over 11 million adults in the U.S. vape nicotine [15] - 65% of smokers attempt to quit annually, with fewer than 10% succeeding [15] Company Strategy and Industry Competition - The company is transitioning from a clinical development focus to a more commercially focused strategy, with plans for NDA submission, acceptance, and approval [5][6] - Achieve is developing an innovative digital-first commercial strategy to target primary care physicians efficiently [11][12] - The company is exploring partnerships for COPD and asthma treatments, leveraging cytisinicline's potential in reducing smoking-related diseases [51] Management Commentary on Operating Environment and Future Outlook - Management emphasized the urgent need for new FDA-approved treatments for smoking cessation, highlighting the public health crisis caused by nicotine dependence [25][26] - The company is focused on executing its NDA submission plan, with a target submission date in Q2 2025 [22][23] - Achieve is optimistic about addressing future nicotine dependence crises, including tobacco pouches, after focusing on smoking and vaping cessation [52] Other Important Information - The FDA granted breakthrough therapy designation to cytisinicline for vaping cessation, providing access to FDA cross-disciplinary project management teams [26] - The company successfully refinanced its SVB loan, securing up to $20 million in availability, with tranches tied to NDA acceptance and FDA approval [43][44] Q&A Session Summary Question: Spike in G&A expenses in Q3 - The spike was due to one-time charges related to executive restructuring and severance costs [56] Question: ORCA-OL trial patient exposure - Approximately one-third of participants had prior exposure to cytisinicline for 12 weeks, one-third for 6 weeks, and one-third were in the placebo group [57] Question: ORCA-OL data disclosure - Data will not be presented before NDA submission; focus remains on safety data and NDA preparation [61] Question: Vaping cessation label expansion - Efforts are focused on smoking cessation first, with plans to expand into vaping cessation after establishing the commercial structure [63] Question: ORCA-OL enrollment reduction - Enrollment was capped at 479 due to low discontinuation rates, with retention programs in place to maintain participant engagement [83][84] Question: NDA review timeline - The NDA review process is expected to take 12 months from submission, with FDA acceptance within 74 days [86] Question: Non-dilutive financing for vaping study - The company is still considering leveraging NIH funding for the vaping study [87] Question: Synthetic cytisinicline development - Progress is ongoing, with updates to be provided as significant developments occur [78]