Achieve Life Sciences, Inc. Q4 FY2024 earnings call

Rick Stewart noted Achieve expects to submit the NDA for cytisinicline as a smoking cessation treatment to the FDA by the end of next quarter. Key 2024 milestones included completing ORCA Open Label trial enrollment, Breakthrough Therapy designation for vaping cessation, Phase 2 meeting with FDA on vaping cessation, leadership team strengthening, and commercial readiness advancement. Cindy Jacobs discussed NDA submission progress, finalizing safety/efficacy docs, ORCA Open Label trial details, and FDA agreement on Phase 3 vaping study design. Jaime Xinos outlined commercial readiness efforts: product label development, packaging finalization, 3PL partner selection, launch readiness priorities (awareness, access, availability), payer engagement, and patient/prescriber segmentation refinement. Mark Oki reviewed financials: cash at $34.4M as of Dec 31, 2024; Q4 and annual operating expenses at $12.2M and $39.1M, respectively; net losses at $12.4M and $39.8M.

Achieve expects to submit the NDA for cytisinicline as a smoking cessation treatment to the FDA by the end of Q2 2025. Plan to initiate Phase 3 ORCA-V2 clinical trial for vaping cessation within the first half of 2026 dependent on financing. Confident in filing the NDA as planned and bringing cytisinicline to market.

Q: Regarding the NDA for smoking cessation to be filed at end of 2Q, what still needs to be done prior to submission, CMC status, and external help?

A: Rick Stewart mentioned focus on NDA execution, Cindy Jacobs noted finalizing efficacy and safety summary documents, CMC sections almost done, and external consultants used.

Q: On commercial side, access for cytisinicline, PA/step edits, specialty pharmacy?

A: Jaime Xinos discussed considering specialty pharmacy, preparing for payer contracting, and addressing barriers to access.

Q: Closer to partner for comorbid indication, potential partnerships?

A: Rick Stewart stated focus on NDA submission, but interested parties in COPD impact, and evaluating partnerships on merits.

Q: Future DSMC reviews for open label safety, CMC mock reviews with Sopharma, G&A costs?

A: Cindy Jacobs said one more DSMC review for one year safety data, Richard Stewart mentioned using resources for NDA quality, Mark Oki said 4.9 G&A is a good starting point.

Q: Sales ramp, partnership, physician/patient segmentation?

A: Cindy Jacobs said slow ramp due to access/awareness, focus on high volume prescribers and motivated quitters, Rick Stewart mentioned commercialization strategy includes digital first.

Q: Exclusivity, generics barrier, drug derivation from plant extraction?

A: Richard Stewart said plant extraction and IP estate create barriers for generics.

Q: Patient/physician conversion, commercial approach for vaping?

A: Cindy Jacobs and Richard Stewart discussed patient success with cytisinicline, digital first commercial approach for both smoking and vaping.

Q: JAMA articles on smoking during pregnancy, vaping ineffectiveness, Sopharma manufacturing, product name?

A: Cindy Jacobs and Richard Stewart discussed expanded opportunity with pregnancy, vaping ineffectiveness aligns with focus on nicotine cessation, Sopharma manufacturing planned in anticipation, product name precondition approved but not shared yet.

Q: Vaping study placebo effect, Phase 3 study power?

A: Cindy Jacobs said Phase 3 study is powered to accommodate higher placebo rates, estimated 800 subjects with 400 per arm.