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Achieve Life Sciences (ACHV) investor relations material
Achieve Life Sciences Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary6 Nov, 2025
Executive summary
Achieved major regulatory milestones, including FDA acceptance of the NDA for cytisinicline for smoking cessation and receipt of the FDA Commissioner's National Priority Voucher (CNPV) for the vaping indication, expediting review timelines; PDUFA date set for June 20, 2026.
Cytisinicline positioned to become the first FDA-approved treatment for nicotine vaping dependence and a new option for smoking cessation after nearly 20 years without new FDA-approved therapies.
Advanced commercial preparations with a focus on availability, access, and awareness, leveraging AI-driven strategies, digital and field-based sales infrastructure, and partnerships to optimize launch and engagement.
Strengthened leadership team with key promotions and hires, including the appointment of a new Chief Legal Officer, to support regulatory and commercial execution.
No commercial products or revenue to date; net loss of $40.0 million for the nine months ended September 30, 2025.
Financial highlights
Ended Q3 2025 with $48.1 million in cash, cash equivalents, and marketable securities, up from $34.4 million at December 31, 2024.
Operating expenses were $14.7 million for Q3 2025 and $40.1 million for the nine months ended September 30, 2025.
Net loss was $14.4 million for Q3 2025 and $40.0 million for the nine months ended September 30, 2025.
R&D expenses for the nine months ended September 30, 2025 were $19.1 million; G&A expenses were $21.0 million.
Net cash used in operating activities was $31.5 million for the nine months ended September 30, 2025.
Outlook and guidance
PDUFA date for cytisinicline in smoking cessation set for June 20, 2026, with commercial launch targeted for Q3 or Q4 2026.
Vaping indication could launch 8 months earlier than standard review timelines due to CNPV, with phase 3 trial (Orca V2) initiation preparations underway.
Proactive payer engagement and access strategy to begin in Q1 2026, aiming for rapid and broad coverage at launch.
Current resources are insufficient to fund planned operations for the next 12 months; additional capital is required.
How to leverage COPD data for market penetration
How does AI strategy optimize launch ROI
Vaping study funding and acceleration strategy
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Next Achieve Life Sciences earnings date
Q4 202513 Mar, 2026
Next Achieve Life Sciences earnings date
Q4 202513 Mar, 2026
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Frequently asked questions
Achieve Life Sciences, Inc. is a biopharmaceutical company focused on the development and commercialization of therapies to aid in smoking cessation. The company’s lead product candidate is based on cytisinicline, a plant-based alkaloid that is being developed to help people quit smoking by reducing nicotine cravings and withdrawal symptoms. Achieve Life Sciences is engaged in clinical trials to advance its therapeutic offerings aimed at addressing nicotine addiction. The company is headquartered in Seattle, United States, and its shares are listed on the NASDAQ.
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