What Management Said

Read the full Q3 2025 transcript ↗

A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website. Having served as our Head of Medical Affairs since 2024, he brings a strong understanding of our programs, pipeline, and strategic objectives, along with real-world experience treating patients who are eager to quit nicotine. Furthermore, we were pleased to report that our last Orca OL participant completed the study in October, marking 334 participants who completed one full year of the trial.

Seeing participants stay committed for a full year truly underscores the tolerability and appeal of cytisinicline. We ended the third quarter with a strong balance sheet supported by our recent capital raise and continued financial discipline. We remain focused on disciplined capital allocation as we advance toward key regulatory and commercial milestones.

Does that change your commercial infrastructure outlook or how you're looking at sort of launching these two products in tandem?

What went well
  • The FDA accepted Achieve's new drug application (NDA) for cytisinicline in smoking cessation and set a PDUFA target action date of June 20, 2026; management said all interactions with the FDA remain normal and on track.
  • The FDA awarded Achieve a Commissioner's National Priority Voucher (CNPV) for the e-cigarette/vaping cessation indication - one of only nine therapies selected in the program's inaugural year - which management expects to compress the NDA review to 1-2 months (versus a standard 10-12 months) and enable a launch roughly eight months earlier than expected, positioning cytisinicline to potentially become the first and only FDA-approved treatment for the ~60% of U.S. e-cigarette users who want to quit.
  • The ORCA-OL open-label long-term exposure study delivered strong results: the last participant completed the study in October with 334 participants finishing a full year, the fourth and final DSMC safety review found adverse events mostly mild with no treatment-related serious adverse events, and the 120-day safety update included 411 individuals with at least six months and 214 with at least one year of cumulative cytisinicline exposure.
  • Exit-survey feedback from ORCA-OL was highly favorable, with over 97% of respondents believing cytisinicline helped them quit or reduce nicotine use and nearly all indicating they would recommend it to a friend or family member.
  • New post-hoc data from the ORCA-2 and ORCA-3 phase 3 trials published in Thorax showed cytisinicline significantly improved quit rates versus placebo in adults with COPD (odds ratio 5.3 with COPD versus 5.2 without), while COPD smokers on placebo essentially could not quit - supporting cytisinicline's potential in a hard-to-treat population of ~6 million U.S. COPD smokers.
  • Commercial launch preparation advanced across availability, access, and awareness: a third-party logistics (3PL) provider was selected for Q4 2025 implementation, the Washington State home-state licensing application was accepted, a Specialty Lite Hub partner was chosen, and payer segmentation plus pricing and contracting research were completed with the Omnicom partnership building a unified AI-enabled data ecosystem.
  • Achieve ended the quarter with a strengthened balance sheet of $48.1 million in cash following a recent capital raise, and made key leadership moves - Dr. Mark Rubinstein named interim CMO, Craig Donnelly promoted to COO, and Eric Atkinson hired as Chief Legal Officer.
What went wrong
  • Achieve remains pre-revenue and continued to post losses, with a net loss of $14.4 million for the quarter and $40 million for the nine months ended September 30, 2025.
  • The current $48.1 million cash runway funds operations only into the second half of 2026 and does not cover the planned ORCA vaping phase 3 trial; management confirmed additional capital will be required to complete the vaping study.
  • The ORCA vaping phase 3 (ORCA-V2) has not yet started - management is still finalizing the study protocol, selecting sites, and identifying a principal investigator, and intends to return to the FDA to seek trial-design streamlining under the CNPV before initiating.

Guidance Changes

MetricPeriodCurrent guidance
PDUFA target action date (smoking cessation NDA)2026June 20, 2026 (NDA accepted this quarter)
U.S. commercial launch (smoking cessation)2026Expected Q3 or Q4 2026
Cash runwayInto H2 2026Expected to fund operations into the second half of 2026 (excludes vaping trial, which needs additional capital)
Vaping indication launch timingPost-smoking launchEstimated ~12-14 months after the smoking cessation launch; CNPV expected to shorten NDA review to 1-2 months
ORCA-OL database lockYear-end 2025On track to lock by year-end, with presentations and further publications planned for 2026

Performance Breakdown

MetricYoYNote
Cash, cash equivalents and marketable securities $48.1M as of Sept 30, 2025 Supported by a recent capital raise and continued financial discipline; expected to fund operations into H2 2026.
Total operating expenses $14.7M (Q3); $40.1M (9 months) Reflects ongoing investment in regulatory, clinical, and pre-commercial activities.
Net loss $14.4M (Q3); $40.0M (9 months) Pre-revenue clinical-stage operations advancing toward key regulatory and commercial milestones.
NDA regulatory progress (smoking cessation) NDA accepted; PDUFA June 20, 2026 FDA accepted the NDA and 120-day safety update was submitted on time; all FDA interactions normal.
CNPV designation (vaping) Awarded Oct 2025 One of nine inaugural-year therapies; provides enhanced FDA engagement and a 1-2 month review timeline.
ORCA-OL long-term exposure 334 completed 1 year; 411 ≥6 mo / 214 ≥1 yr exposure Fourth/final DSMC review found no treatment-related serious adverse events; last participant completed in October.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Vaping/e-cigarette cessation opportunity (CNPV)—CNPV award reframes vaping as a major second value driver - potential first-ever FDA-approved treatment for the ~17 million U.S. adult e-cigarette users (~60% want to quit); ORCA-V2 phase 3 in start-up, though it requires additional capital and FDA design discussions.—
Smoking cessation market and unmet need—~29 million U.S. adults smoke and >15 million try to quit yearly; no new FDA-approved option in nearly 20 years; management estimates ~7 million highly motivated quitters as the initial target and frames nicotine dependence as a medical condition akin to obesity/GLP-1s.—
COPD subgroup—Thorax publication showed cytisinicline works as well in COPD smokers (odds ratio 5.3) as non-COPD (5.2) while placebo patients could not quit; ~6 million U.S. COPD smokers represent a distinct opportunity and possible respiratory-partner interest.—
AI-driven, data-led commercial platform—Achieve is building a lean, AI/ML-enabled omnichannel platform (unified HIPAA-compliant data warehouse, Omnicom MarTech partnership) for next-best-action targeting of HCPs, patients, and payers to minimize launch infrastructure cost.—
Competitive landscape (Chantix/varenicline)—On Pfizer reintroducing Chantix, management was skeptical of the ROI given generic varenicline dominance and emphasized cytisinicline's superior tolerability (~5x less nausea/vomiting, less than half other side effects) in an ~8 million-script annual market.—

Q&A Summary

Thomas Flatten (Lake Street) asked whether the selected specialty distributor meant a specialty-only route or whether a complementary retail strategy was also planned.
Rick Stewart (filling in for Jamie Xinos, who had stepped away) said there will be a complementary retail strategy as well; the specialty route is the quickest and optimal path in the initial stages, with build-out from there.
Thomas Flatten (Lake Street) asked Mark Oki to confirm that the cash runway into the second half of 2026 does not contemplate funding the vaping study.
Mark Oki confirmed that completing the vaping study will require raising additional capital.
Thomas Flatten (Lake Street) asked for detail on the anticipated vaping study protocol and endpoint, noting objective breath analysis is not possible for vapers.
Rick Stewart described a two-arm study very similar to the smoking-cessation trials - placebo versus cytisinicline 3 mg three times daily for 12 weeks, roughly 400 patients per arm, with vapers treated for 12 weeks only (they are viewed as more nicotine-dependent). Stewart and Dr. Mark Rubinstein said the primary endpoint is overall quit rates at the end of 12 weeks of treatment with a 24-week follow-up, and that biochemical confirmation will use blood and/or saliva testing for cotinine (a nicotine biomarker) rather than breath CO.
Gary Nachman (Raymond James) asked how Achieve could accelerate and potentially start the vaping phase 3 earlier, and whether the design would be the same as previously described.
Rick Stewart called the CNPV extremely valuable (accelerating launch and peak revenues by roughly eight to nine months) and said Achieve will return to the FDA to seek streamlining of the agreed trial design, reinforced by its existing breakthrough designation. Dr. Mark Rubinstein confirmed a 12-week trial of cytisinicline plus behavioral support versus placebo plus behavioral support, with follow-up at 12 and 24 weeks, biochemical confirmation via cotinine, and the same dosing as smoking cessation.
Gary Nachman (Raymond James) asked for more detail on the COPD benefit and whether Achieve is still in partner conversations for a study in that group.
Rick Stewart called the benefit in COPD smokers remarkable, noting they are highly nicotine-dependent and that smoking impairs their corticosteroid and anti-IL-33 treatments, so cytisinicline could make existing therapies more effective across ~6 million U.S. COPD smokers - a population respiratory companies should find interesting. Dr. Mark Rubinstein added that COPD patients were older, heavier smokers with higher dependence and depression, yet achieved quit rates similar to non-COPD patients (odds ratio 5.3 vs 5.2), while placebo patients essentially could not quit.
Gary Nachman (Raymond James) asked about Pfizer reportedly bringing Chantix back and its impact on the smoking-cessation market and pricing.
Rick Stewart questioned the ROI of promoting Chantix given generic varenicline has taken over the market, and argued cytisinicline is clearly differentiated on efficacy and a superior side-effect profile - about five times less nausea and vomiting and less than half the other side effects (sleep disturbances, abnormal dreams, headache). He sized the market at ~8 million annual smoking-cessation scripts (Chantix peaked near 2.8 million, ~75% U.S.) and did not view competition as a stumbling block.
Brandon Fox (HC Wainwright) asked about commercial-infrastructure overlap between smoking and vaping, whether an earlier vaping launch changes the go-to-market approach, and manufacturing readiness.
Rick Stewart said the vaping indication is estimated to launch roughly 12-14 months after smoking cessation, allowing lessons from the first launch to be applied. Vaping targets a much younger, more digitally inclined population (average age ~33-35, vaping 5-8 years) versus the ~55-year-old, ~30-year smoking cohort (with ~7 million of ~29 million smokers seen as highly motivated quitters), while the physician approach is unchanged. Manufacturing is identical - 3 mg three times daily - with vaping treated over 12 weeks only versus the 6- or 12-week flexibility in smoking cessation.

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Q3 2025 call
Reported 2025-11-06 · figures from the Achieve Life Sciences, Inc. Q3 2025 earnings call.

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