Achieve Life Sciences outlines expedited FDA review for cytisinicline and targets Q3/Q4 2026 launch

Earnings Call Insights: Achieve Life Sciences (ACHV) Q3 2025

MANAGEMENT VIEW

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CEO Richard A. Stewart described the quarter as "another truly significant quarter for Achieve in our mission to get a new treatment for nicotine dependence into the hands of patients," highlighting the FDA's award of a Commissioner's National Priority Voucher (CNPV) for cytisinicline's vaping indication. Stewart emphasized, "The CMPV is designed to provide enhanced FDA communications and an expedited NDA review time line, reducing the potential NDA approval to 1 to 2 months from a standard 10 to 12 months... A rapid approval of the vaping indication means cytisinicline could be launched 8 months earlier than expected."

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Stewart noted the FDA acceptance of the new drug application (NDA) for cytisinicline for smoking cessation, with a set PDUFA date of June 20, 2026. He also referenced positive regulatory milestones, including timely submission of safety data and ongoing normal interactions with the FDA.

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Stewart announced management changes: Dr. Mark Rubenstein promoted to Interim Chief Medical Officer, Craig Donnelly to Chief Operations Officer, and Eric Atkinson joining as Chief Legal Officer.

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Stewart discussed the company's AI-driven commercial strategy, stating Achieve "leverages AI and machine learning to drive next best action orchestration, omnichannel marketing and audience activation across health care professionals, patients and payers," aiming for a scalable, cost-efficient model ahead of the anticipated launch.

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Chief Commercial Officer Jaime Xinos outlined commercial launch preparations, including "selected our third-party logistics provider and will begin the implementation process in Q4, well ahead of potential approval" and progress on licensing and distribution. Xinos described efforts to secure payer coverage, finalize pricing research, initiate payer engagement in Q1, and advance digital marketing infrastructure with Omnicom.

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Chief Financial Officer Mark Oki stated, "As of September 30, 2025, cash, cash equivalents and marketable securities totaled $48.1 million... our current cash runway is expected to fund operations into the second half of 2026." Oki reported total operating expenses for the quarter at $14.7 million and a net loss of $14.4 million.

OUTLOOK

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Stewart projected, "a launch in the third or fourth quarter of 2026" for cytisinicline, with the vaping indication potentially 8 months earlier than previously anticipated due to the CNPV.

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Dr. Rubenstein confirmed the regulatory process is on track, with the ORCA-OL database expected to lock by year-end and further presentations planned for 2026.

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Xinos affirmed, "As we look ahead to our potential launch in 2026, our path is clear. We are committed to delivering cytisinicline to the millions of Americans seeking a better path to quit nicotine."

FINANCIAL RESULTS

* Oki reported $48.1 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Total operating expenses for the quarter were $14.7 million, with a net loss of $14.4 million. The current cash runway is projected to last into the second half of 2026.

Q&A

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Thomas Flaten, Lake Street Capital Markets: Asked about the distribution strategy. Jerry Wan, VP of Finance, responded there will be a "complementary retail strategy in place as well. But the specialty route is one of the quickest and I think the optimal route at least in the initial stages, and then we'll build out from there."

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Flaten: Queried about cash runway and funding for the vaping study. CFO Oki confirmed, "to complete the vaping study, we'll need to raise additional capital."

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Flaten: Requested details on the vaping study protocol. Stewart replied, it will be a "2-arm study, placebo for 3 milligram 3 times daily for 12 weeks... roughly 400 patients in each arm," with differences in duration versus the smoking cessation trials due to higher nicotine dependence in vapers.

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Gary Nachman, Raymond James: Asked about acceleration for the vaping Phase III. Stewart explained, "the CNPV allows us a once 2 months of approval... we are going to go back to the agency because I think we need to take advantage of the benefits under the CNBV to see where we could streamline the agreed clinical trial design."

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Nachman: Sought details on cytisinicline's COPD patient data. Stewart and Dr. Rubenstein described quit rates in COPD smokers on cytisinicline as matching those without COPD and indicated placebo quit rates were negligible.

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Nachman: Asked about CHANTIX's reintroduction. Stewart compared side effect profiles and market dynamics, highlighting cytisinicline's advantage.

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Brandon Folkes, H.C. Wainwright: Queried about commercial overlap between smoking cessation and vaping indications. Stewart noted a staggered launch, with vaping following by 12-14 months and targeting a younger, more digitally engaged population.

SENTIMENT ANALYSIS

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Analysts focused on clarification of commercial strategy, regulatory acceleration, funding needs, and competitive positioning. Their tone was neutral with occasional positive notes, such as congratulating management on progress.

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Management maintained a confident and forward-looking tone throughout, repeatedly emphasizing execution and momentum, as well as the significance of regulatory milestones. Stewart stated, "We are energized and excited about the opportunities ahead and confident that our efforts will deliver meaningful benefits for patients and long-term value for our stockholders."

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Compared to the previous quarter, management's tone has become more assertive about timelines and the impact of regulatory developments, while analysts continue to probe on commercial and financial execution risks.

QUARTER-OVER-QUARTER COMPARISON

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The current quarter featured the award of the CNPV and a focus on expedited FDA review, which was not present last quarter. Management provided a firm PDUFA date and a more detailed launch timeline, while in the previous quarter, the expectation was for NDA acceptance and regulatory milestones still pending.

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Commercial strategy updates in the current quarter included concrete steps in logistics, payer research, and digital infrastructure, compared to earlier-stage preparations last quarter.

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Analysts' focus shifted toward the specifics of the vaping indication and funding for new trials, whereas last quarter they concentrated on safety data, NDA process, and initial commercial groundwork.

RISKS AND CONCERNS

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Management acknowledged the need for additional funding to complete the vaping study.

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The company is preparing for potential launch challenges, including building infrastructure, payer coverage, and targeting distinct patient populations.

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Analyst questions highlighted operational execution and competitive landscape as ongoing concerns.

FINAL TAKEAWAY

Achieve Life Sciences management underscored a transformative quarter marked by the FDA's CNPV award for cytisinicline's vaping indication, which is expected to expedite regulatory review and enable an earlier launch. With regulatory milestones advancing on schedule, a robust commercial strategy in place, and a strengthened leadership team, Achieve is preparing for a dual launch targeting both smoking and vaping cessation, supported by advanced AI-driven commercialization and a solid financial position projected to sustain operations into late 2026. The company is focused on executing its timelines, addressing funding requirements for new studies, and capitalizing on the recognized public health need for new nicotine dependence treatments.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/achv/earnings/transcripts]

MORE ON ACHIEVE LIFE SCIENCES

* Achieve Life Sciences, Inc. (ACHV) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4839572-achieve-life-sciences-inc-achv-q3-2025-earnings-call-transcript]
* Achieve: Expedited Review Of Cytisinicline Sets The Stage For Development Expansion [https://seekingalpha.com/article/4831084-achieve-life-sciences-stock-expedited-review-cytisinicline-development-expansion]
* Achieve Life Sciences: Promising Pipeline But High Risks Makes Me Hold For Now [https://seekingalpha.com/article/4826918-achieve-life-sciences-promising-pipeline-but-high-risks]
* Achieve Life Sciences Q3 2025 Earnings Preview [https://seekingalpha.com/news/4515917-achieve-life-sciences-q3-2025-earnings-preview]
* Achieve, Disc, Revolution among winners of initial FDA national priority vouchers [https://seekingalpha.com/news/4505159-achieve-disc-among-winners-fda-national-priority-vouchers]