Achieve Life Sciences(ACHV)2024-11-09 12:32Financial Data and Key Metrics - The company's cash, cash equivalents, restricted cash, and short-term investments were 61.3 million in the prior quarter [45] - Net loss for Q3 2024 was 7.1 million in the same quarter of the prior year [46] - Net loss for the nine months ended September 30, 2024, increased to 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]