Achieve Life Sciences, Inc. Q1 FY2025 earnings call

• Rick Stewart stated Achieve is on track to submit the NDA for cytisinicline next month, with internal resources focused on a successful submission, acceptance, and approval. The potential of cytisinicline in treating nicotine dependence was highlighted, with over 29 million US adults smoking and 11 million vaping, and cytisinicline having excellent efficacy and tolerability.
• Cindy Jacobs discussed progress in the ORCA-OL open label study, including reaching milestones like 300 participants with 6 months of safety data and 100 participants with 1 year of safety data, positive Data Safety Monitoring Committee reviews, and the Scientific Advisory Board meeting. The Phase 3 ORCA-3 trial results were published in JAMA Internal Medicine, reaffirming cytisinicline's efficacy and tolerability.
• Mark Oki reviewed financials, emphasizing cash management and prudent spending to support key priorities like getting cytisinicline to market.
• Rick Stewart highlighted cytisinicline's potential impact on comorbidities like COPD and asthma, with smokers with COPD showing higher quit rates on cytisinicline.

No specific product segment financial performance details provided. Total operating expenses for the first quarter of 2025 were $12.9 million, net loss was $12.8 million, and cash, cash equivalents, and marketable securities were $23.2 million as of March 31, 2025.

• On track to submit the NDA for cytisinicline next month.
• Anticipate receiving a 74 day letter from the FDA acknowledging NDA submission, with NDA approval expected in approximately 12 months from submission date.
• Cash management is a priority to extend cash runway and keep focus on the NDA.

Q: How long before we see the full safety data from the long-term study? How will you present that? What will it be after you update the NDA with the one year data? And when you say 75% of the enrolled patients remain on treatment in the long-term study, what's the average duration for patients getting cytisinicline? And is that reflective of how it will be used in a real world setting? And then what were some of the key takeaways from the SAB meeting and how did that inform you for your filing and also for your commercial plans?

A: Cindy Jacobs responded about the open label study timeline, SAB meeting insights on cytisinicline's applications.

Q: I'd love to hear if you notice any changes in your interactions with the FDA.

A: Cindy Jacobs stated no real changes in FDA interactions, with responsive communication as usual.

Q: On the last call, you mentioned that you'd be discussing pricing with payers. I'm not sure if that happened yet. But if they have, have those conversations gone? And are there any products that they're using as comparison to determine pricing? And then also on that same topic, are there any pharmacoeconomic elements guiding the discussion?

A: Jaime Xinos responded about payer conversations, pricing comparators, and pharmacoeconomic elements in the discussion