Achieve Life Sciences, Inc. Q1 FY2026 earnings call

• Leadership Update

  • Dr. Andrew Goldberg, a physician with 20 years of clinical experience and 10 years of healthcare board and investment experience, has taken over as CEO, succeeding co-founder Rick Stewart who built the company through NDA acceptance.
  • Three new board members were appointed: Chris Martin (former CCO of Verona Pharma, with deep pulmonary launch experience), Dr. Lucian Iancovici (TPG Managing Director), and Dr. Aaron Royston (VenBio Managing Partner), all bringing scaling, FDA approval, and commercial execution expertise.
  • Two additional senior commercial leaders from Verona Pharma joined the team: Mark Zappia as SVP of Commercial and Jim Willis as VP of Sales and Enablement, who will lead the upcoming commercial launch field force.

• Financing

  • Achieve closed a transformational private placement financing, securing $180 million in upfront capital, plus up to $174 million in additional milestone-based warrants exercisable up to 20 trading days after FDA approval, from a syndicate of leading specialist healthcare investors. This provides sufficient capital to execute through commercial launch.

• Manufacturing and Regulatory Progress

  • The company transitioned primary commercial manufacturing to U.S.-based Adair Pharma Solutions to eliminate risks associated with international importation and tariffs. The first cytisinicline engineering batch was produced at Adair's facility in Q1 2026.
  • Achieve expects to receive a Complete Response Letter (CRL) from the FDA by the June 20, 2026 PDUFA date, due to an Official Action Indicated (OAI) classification at the prior third-party manufacturer. The CGMP observations are not specific to cytisinicline.
  • The company plans to resubmit the New Drug Application (NDA) for cytisinicline (for smoking cessation) in Q4 2026 with Adair named as the new primary manufacturer, targeting a commercial launch in H1 2027.

• Scientific and Clinical Updates

  • New mechanistic data published in Nicotine and Tobacco Research confirmed that cytisinicline selectively binds to the alpha-4, beta-2 nicotinic receptor with minimal interaction with the 5-HT3 serotonin receptor, explaining the low nausea rates observed in clinical trials.
  • A Phase III post-hoc analysis of over 1,600 participants presented at the Society for Research on Nicotine and Tobacco conference showed consistent efficacy across all patient subgroups, including those who had failed prior approved therapies (varenicline or bupropion). Among this treatment-refractory population, 32.4% of cytisinicline-treated patients achieved 12-week continuous abstinence, compared to 6% of placebo patients (odds ratio 7.5).

• Market Opportunity

  • There are nearly 50 million nicotine users in the U.S. (25 million smokers, 18 million vapers), and no new FDA-approved smoking cessation therapy has been launched in over 20 years, with no approved therapy ever for vaping cessation. Cytisinicline is positioned to fill this large unmet need.

No product segment financial performance data was reported in this Q1 2026 earnings call transcript, as Achieve Life Sciences remains in late-stage development and has not yet launched its lead candidate cytisinicline commercially.

• NDA resubmission for cytisinicline (smoking cessation) is still targeted for Q4 2026, following the planned transition to Adair Pharma Solutions as primary manufacturer.
• Commercial launch of cytisinicline in the U.S. is still projected for the first half of 2027, and management has not seen any issues to date that would change this timeline.
• The company hopes to initiate the ORCA-V2 Phase III trial for vaping cessation in 2026, and will provide further timeline updates as the trial design is finalized.
• New additional clinical data on cytisinicline, including 52-week safety and efficacy data and data on use among patients with cancer, is expected to be presented at scientific conferences later in 2026.

• The prior third-party manufacturer received an OAI classification for general CGMP issues not related to cytisinicline, which is expected to result in a CRL from the FDA at the June 2026 PDUFA date, requiring an NDA resubmission that has been scheduled for Q4 2026.
• There is inherent execution risk associated with the technology transfer of cytosinicline manufacturing to the new U.S.-based partner Adair Pharma Solutions, though management is confident the timeline will hold.
• Forward-looking statements regarding approval timelines, trial initiation, launch plans, and future performance are not guarantees, and actual results may differ materially due to regulatory outcomes, manufacturing delays, and other unforeseen risks.

Q: What is Achieve's 2026 commercial strategy to prepare for 2027 launch, and how is the company building awareness among prescribers of existing smoking cessation therapies? / A: Achieve plans to commercialize cytisinicline independently with its own dedicated field force, supported by the newly hired senior commercial leadership team with deep successful launch experience. Pre-approval regulatory rules limit the company's commercial communication, but the team will continue sharing existing and new clinical data via scientific conferences in 2026, and will expand the medical education team as launch approaches. The new financing provides sufficient capital to execute on this independent commercial strategy.

Q: What content will be included in the NDA resubmission, how is Adair's manufacturing progress going, and is Adair able to meet projected demand? / A: The CRL is expected to focus on the OAI classification of the prior third-party manufacturer, which is the reason for the transition to Adair. The first engineering batches have already been completed at Adair's FDA-registered facility, and the CEO personally visited the site early in his tenure to oversee progress. The team is prioritizing completing the tech transfer as fast as possible while maintaining quality, has the capital to ramp up resources if needed, and is confident Adair can meet demand.

Q: How much due diligence was done on cytisinicline's intellectual property, how confident is management in the current NDA resubmission and launch timeline, and what is the status of the vaping cessation Phase III trial? / A: Extensive IP due diligence was done by both the CEO and the new financing syndicate, and management is confident IP protection for cytisinicline extends through the late 2030s and into the 2040s. To date, no issues have been identified that would prevent the team from meeting the Q4 2026 NDA resubmission and H1 2027 launch timeline, and the company will provide transparent updates if any changes occur. The ORCA-V2 Phase III trial design for vaping cessation is being finalized, and the company hopes to initiate the trial in 2026.

Q: How does Achieve view the competitive landscape of new emerging smoking cessation approaches (GLP-1s, digital tools, flavored vapes, psilocybin), and what is cytisinicline's position? / A: Increased attention on nicotine cessation from new emerging approaches is helpful, as it brings more patient and provider attention to the unmet need. Achieve has a robust, late-stage program with completed Phase III trials, and cytisinicline is an easy-to-dose oral pill with no required titration or injections, and a well-established favorable tolerability profile, giving it a strong competitive position in this growing market.