Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled $36.4 million [22] - Total operating expenses for Q4 2025 were $14.7 million, and for the full year, they were $54.9 million, reflecting ongoing investments in regulatory, clinical, and commercial activities [22] - The total net loss for Q4 2025 was $14.7 million, and for the full year, it was $54.7 million [22] Business Line Data and Key Metrics Changes - The NDA submission in June 2025 marked a transition for the company from clinical development to a commercially focused enterprise [4] - The company aims to make cytisinicline available to 25 million smokers and nearly 18 million vapers in the U.S. [4] - The ORCA-OL long-term exposure trial demonstrated cytisinicline's safety profile, showing strong tolerability and excellent patient satisfaction [6] Market Data and Key Metrics Changes - Approximately 25 million adults in the U.S. smoked cigarettes in 2024, with over 15 million attempting to quit annually [10] - There are 6 million COPD smokers in the U.S. with limited options to help them quit, highlighting the need for effective treatments [6] Company Strategy and Development Direction - The company is focused on launching cytisinicline as the first FDA-approved treatment for nicotine dependence in 20 years [5] - Achieve Life Sciences is building a scalable, data-driven commercial model to effectively target physicians and patients [7] - The partnership with Adare Pharma Solutions aims to secure the supply chain and reduce risks associated with international pharmaceutical importation [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory progress and the potential for cytisinicline to deliver a new treatment option for nicotine dependence [16] - The company is committed to addressing the public health crisis of nicotine dependence and is actively building for the product launch [24] - The management emphasized the importance of a controlled and successful launch, ensuring all processes are in place [32] Other Important Information - The company received the FDA Commissioner's National Priority Voucher for vaping cessation, which provides an expedited review timeline [16] - The Willpower awareness campaign was launched to reframe the conversation around nicotine dependence as a medical condition [11] Q&A Session Summary Question: Can you talk about the critical path between a late June NDA approval and a first half launch? - The company needs to ensure drug availability in the supply chain before market entry, with all trade and distribution processes ready upon drug availability [27][28] Question: Did you imply that the manufacturer in the NDA will not be supplying commercial product, rather Adare will? - The company confirmed that the PDUFA date remains unchanged, and the decision to transfer manufacturing to the U.S. was made to ensure supply chain security [33] Question: Can you talk about healthcare provider awareness and additional work in 2026? - The company has been conservative in spreading awareness prior to product availability but plans to ramp up educational efforts as the launch approaches [38] Question: What is the status of the FDA dialogue on the vaping indication since receiving the CMPV? - Discussions with the FDA have focused on protocol approval, with site selection for the ORCA-V2 phase III trial already underway [40][41] Question: How robust is the raw plant material supply chain? - The company has been stockpiling starting material and expects to have more than three years' supply by the time of launch [56] Question: What is the cytisinicline dosing schedule and potential compliance concerns? - High adherence rates were reported in trials, with participants finding the dosing schedule manageable and effective in addressing cravings [58][59] Question: What are the pricing considerations for cytisinicline? - The company is not ready to comment on pricing but acknowledges the substantial unmet need highlighted in the ICER report [62][65]

Core Insights - Achieve Life Sciences has received a Commissioner's National Priority Voucher from the FDA for cytisinicline, aimed at treating nicotine dependence specifically for e-cigarette or vaping cessation, marking it as one of only nine therapies in the inaugural year of the program [1][4] - Cytisinicline is positioned as a first-in-class pharmacotherapy for a significant unmet medical need, with around 60% of the 17 million adult e-cigarette users in the U.S. wanting to quit [2][9] - The FDA has granted Breakthrough Therapy designation to cytisinicline, which demonstrated clinical efficacy in the Phase 2 ORCA-V1 trial, showing participants were 2.6 times more likely to quit using nicotine e-cigarettes compared to placebo [3][9] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline to address nicotine dependence and has submitted a New Drug Application (NDA) for smoking cessation, with a target action date of June 20, 2026 [5][6] - The company aims to pioneer the first FDA-approved treatment for vaping cessation, addressing a critical gap in treatment options for nicotine dependence [3][4] Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over 8 million deaths globally [7][8] - The vaping market is also significant, with around 17 million adults in the U.S. using e-cigarettes, and no FDA-approved treatments currently available for vaping cessation [9][10]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $23.2 million [19] - Total operating expenses for Q1 2025 were $12.9 million, resulting in a net loss of $12.8 million [19] 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 [6][12] - The ORCA-OL open label study has over 100 patients with one year of exposure to cytisinicline, demonstrating strong tolerability [10][14] 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 [7] - Cytisinicline is positioned to be the first new nicotine dependence drug in nearly 20 years, addressing a significant unmet need in the market [8][17] Company Strategy and Development Direction - The primary focus is on treating nicotine dependence and addressing comorbidities associated with smoking, such as COPD [21][22] - The company aims to build a foundation for long-term growth and create lasting value for stockholders through prudent cash management and resource allocation [19][20] 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 [6][66] - The company anticipates a 12-month timeline for NDA approval following submission, with a potential commercial launch in 2026 [20][66] Other Important Information - The ORCA-three clinical trial results were published in JAMA Internal Medicine, reaffirming cytisinicline's efficacy and tolerability [15][16] - The company convened a Scientific Advisory Board meeting with experts in nicotine and tobacco cessation research, highlighting the excitement surrounding cytisinicline [15][31] Q&A Session Summary Question: How long before we see the full safety data from the long-term study? - The full safety data will be compiled after the NDA submission and presented at a conference later this year or next year [27] Question: What were some key takeaways from the SAB meeting? - The SAB meeting discussed the applications of cytisinicline treatment and the enthusiasm of key opinion leaders regarding its efficacy and tolerability [29][31] Question: What are the plans for pre-commercial efforts to increase awareness of cytisinicline? - The company is focusing on awareness, availability, and access, ensuring the drug is ready for sale and working on pricing and payer strategies [35][36] Question: What is the status of any partnership discussions for non-dilutive capital? - The company is specifying what it wants from potential partnerships, particularly in the COPD space, and is in discussions with several candidates [41][43] Question: Have there been any changes in interactions with the FDA? - There have been no significant changes; interactions have remained responsive as the NDA submission approaches [47] Question: How are pricing discussions with payers going? - Initial conversations have occurred, but strong perspectives will emerge once pricing is set and further exchanges take place [52] Question: Will the company rely on external partners for commercialization? - The company will heavily rely on agency partners to implement its strategy and build a digital launch roadmap [59]