Achieve Life Sciences(US:ACHV)2025-05-13 13:30Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $23.2 million [16] - Total operating expenses for Q1 2025 were $12.9 million, resulting in a net loss of $12.8 million [16] Business Line Data and Key Metrics Changes - The company is focused on the NDA submission for cytisinicline, which is expected to be submitted in June 2025 [5][10] - The ORCA-OL open label study has over 100 patients with one year of exposure to cytisinicline, demonstrating strong tolerability [8][12] Market Data and Key Metrics Changes - In the U.S., over 29 million adults smoke cigarettes, and 11 million vape, with more than half wanting to quit but fewer than 10% succeeding due to inadequate tools [6] - Cytisinicline is positioned to be the first new nicotine dependence drug in nearly 20 years, addressing a significant unmet need in the market [7][15] Company Strategy and Development Direction - The company aims to change the perception of nicotine dependence as a serious medical condition that requires treatment, similar to how GLP-1 medications have reframed obesity treatment [7] - Achieve Life Sciences is preparing for a potential commercial launch in 2026, focusing on managing resources wisely to support this goal [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA submission process and the potential impact of cytisinicline on public health [19][60] - The company is optimistic about cytisinicline's ability to address comorbidities associated with smoking, particularly in COPD patients [18][19] Other Important Information - The ORCA-three clinical trial results were published in JAMA Internal Medicine, reaffirming cytisinicline's efficacy and tolerability [14] - The company is actively engaging with key opinion leaders to gather insights and support for the NDA filing and commercial plans [13][29] Q&A Session Summary Question: When will the full safety data from the long-term study be available? - The company plans to compile and present the safety data after the NDA submission and the 120-day safety update in October [24] Question: What were the key takeaways from the SAB meeting? - The SAB meeting highlighted the enthusiasm for cytisinicline and discussed its potential applications in various settings, including hospital environments [27][29] Question: What are the plans for pre-commercial efforts to increase awareness of cytisinicline? - The company is focusing on awareness, availability, and access, ensuring that physicians are informed about the new treatment option [33][34] Question: What is the status of partnership discussions for non-dilutive capital? - The company is specifying its needs for partnerships related to COPD and is in discussions with potential candidates [39] Question: Have there been any changes in interactions with the FDA? - There have been no significant changes; interactions have remained consistent as the company approaches the NDA submission [43] Question: How are pricing discussions with payers progressing? - Initial conversations with payers have occurred, but strong perspectives will emerge after pricing is set [48] Question: Will the company rely on external partners for commercialization? - The company plans to leverage agency partners for implementing its digital launch strategy [53] Question: When can the market expect first sales post-approval? - The company anticipates needing some time to establish the drug in the market following approval, aiming for a strong launch as soon as feasible [55]