ACHV — Achieve Life Sciences, Inc.

Achieve Life Sciences Q3 2025 Earnings Call Summary

1. Key Financial Results and Metrics

• Cash Position: As of September 30, 2025, Achieve reported cash, cash equivalents, and marketable securities totaling $48.1 million.
• Operating Expenses: Total operating expenses for Q3 2025 were $14.7 million, with a total of $40.1 million for the first nine months of the year.
• Net Loss: The net loss for Q3 was $14.4 million, and $40 million for the year-to-date.
• Cash Runway: Current cash is expected to fund operations into the second half of 2026, but additional capital will be needed for the vaping study.

2. Strategic Updates and Business Highlights

• Regulatory Progress: The FDA accepted Achieve's New Drug Application (NDA) for cytisinicline for smoking cessation, with a PDUFA date set for June 20, 2026. The company also received a Commissioner's National Priority Voucher (CNPV) for vaping cessation, which could expedite the NDA review process.
• Clinical Trials: Cytisinicline showed promising results in COPD patients, with quit rates comparable to non-COPD smokers. The company is preparing to initiate the ORCA-V2 Phase III trial for vaping cessation.
• Commercial Strategy: Achieve is implementing a data-driven digital commercialization strategy utilizing AI for targeted marketing and engagement with healthcare professionals and patients.
• Leadership Changes: Dr. Mark Rubenstein was promoted to Interim Chief Medical Officer, and Eric Atkinson joined as Chief Legal Officer.

3. Forward Guidance and Outlook

• Achieve aims for a commercial launch of cytisinicline in the third or fourth quarter of 2026. The company is focused on securing broad access and awareness for the drug, with proactive engagement with payers starting in Q1 2026.
• The CNPV is expected to significantly enhance the timeline for launching the vaping indication, potentially leading to an earlier market entry.

4. Bad News, Challenges, or Points of Concern

• Funding Needs: Additional capital will be required to fund the vaping study, which poses a risk to maintaining operational momentum.
• Competitive Landscape: Pfizer is reintroducing CHANTIX, which could create competitive pressure in the smoking cessation market, although Achieve believes cytisinicline has a superior safety profile.
• Market Dynamics: The vaping cessation market is still evolving, and Achieve must navigate the complexities of targeting a younger demographic that may have different engagement needs compared to traditional smokers.

5. Notable Q&A Insights

• Commercial Strategy: Achieve confirmed that while a specialty distributor has been selected, there will also be a complementary retail strategy for cytisinicline.
• Vaping Study Protocol: The vaping study will mirror the smoking cessation trials with a 12-week treatment period, focusing on quit rates as the primary endpoint.
• COPD Patient Benefits: Cytisinicline demonstrated comparable quit rates in COPD patients despite their higher levels of dependence and comorbidities, highlighting its potential effectiveness in this challenging population.
• Market Positioning: Achieve maintains confidence in cytisinicline's differentiation from CHANTIX, citing a significantly lower incidence of side effects, which could enhance its adoption among patients.

Overall, Achieve Life Sciences is positioned for significant advancements in the nicotine dependence treatment space, with a strong focus on regulatory milestones and commercial strategies, despite facing funding and competitive challenges.