What Management Said
Read the full Q2 2025 transcript ↗A replay will be available later today using the information in the earnings press release or by visiting the Achieve website. Thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval.
Thirdly, our investors for their continued support, guidance, and belief in our mission. This precision-targeted approach not only enhances effectiveness, it also improves efficiency and return on investment, ensuring that every dollar spent contributes to measurable outcomes and long-term value creation.
What went well
- Achieve submitted its New Drug Application (NDA) for cytisinicline as a treatment for nicotine dependence (smoking-cessation indication) to the FDA in June 2025, starting the regulatory clock; management called the quarter a defining moment toward the first new smoking-cessation treatment in nearly 20 years.
- The NDA is a comprehensive, well-supported application incorporating non-clinical, manufacturing, and clinical data from the two phase III trials ORCA-2 and ORCA-3 plus long-term safety exposure from ORCA-OL, backed by data from over 2,000 clinical trial participants, including over 300 with at least six months of cumulative cytisinicline treatment.
- Achieve entered a strategic commercial partnership with Omnicom, bringing together seven specialized agencies operating as a single unified team across brand, provider/patient initiatives, market access, PR, media, and marketing technology, giving a lean internal team the scale of a much larger organization.
- The company completed a $45 million underwritten public offering in June (common stock plus warrants) with strong support from existing and new institutional and retail investors, and underwriters later partially exercised the over-allotment for an additional $4.3 million gross (CEO characterized the raise as roughly $49 million), strengthening the balance sheet.
- ORCA-OL passed the FDA's second major safety milestone: as of the end of July, 290 participants had completed one year of cumulative cytisinicline treatment (well beyond the FDA's request for 100+), with the last participant projected to complete treatment by early October.
- Early ORCA-OL exit-survey responses (from 40% of the 290) were encouraging: 98% of respondents believed cytisinicline contributed to their ability to stop or reduce nicotine dependence (fewer cravings, less-intense withdrawal, few/manageable side effects) and 99% would recommend it to a friend or family member.
- Commercial launch preparation advanced across three pillars (availability, access, awareness): Achieve contracted third-party logistics provider Fourth 3PL (named in the NDA) with implementation planned for Q4, submitted its home-state licensing application, hired a new VP of Market Access, and engaged a best-in-class access agency.
What went wrong
- Operating expenses and net loss rose year-over-year as the company increased investment in regulatory, quality, and pre-commercial planning ahead of a potential 2026 launch; net loss was $12.7 million for the quarter.
- Cash of $55.4 million funds operations only into the second half of 2026, implying the pre-revenue company will need additional capital to reach and fund a potential late-2026 launch.
- Management does not view an FDA priority review as a likely outcome and anticipates a standard review; a request for the new Commissioner's National Priority Voucher (CNPV) was submitted but is also not viewed as a likely possibility.
- As a first-time, small-company launch, management acknowledged launching a drug is often seen as a high-risk endeavor, which is why it is leaning heavily on external partners such as Omnicom.
Guidance Changes
| Metric | Period | Current guidance |
|---|---|---|
| FDA Day 74 NDA acceptance letter (with target review completion / PDUFA dates) | Sept 2025 | Expected in mid-September 2025; acceptance defines the PDUFA date and begins the official countdown to a potential approval decision |
| 120-day safety update submission (100+ subjects with one year of exposure) | Oct 2025 | To be submitted in October 2025 during the NDA review period |
| ORCA-OL final database lock | End of 2025 | Company plans to complete all trial activities and lock the final study database by the end of 2025; publications/presentations targeted for 2026 (not required for approval) |
| Potential product approval and commercial launch | Late 2026 | Prepared to launch cytisinicline in late 2026 should it receive FDA approval |
| Cash runway | Into H2 2026 | $55.4M in cash, equivalents, and marketable securities expected to support operations into the second half of 2026 |
| Commercial spending ramp | FY2026 | Incremental and disciplined; a not-excessive ramp begins after NDA acceptance, with a larger increase upon approval |
Performance Breakdown
| Metric | YoY | Note |
|---|---|---|
| Cash, cash equivalents & marketable securities | $55.4M at June 30, 2025 | Strengthened by the June $45M public offering (plus $4.3M over-allotment); expected to fund operations into H2 2026. |
| Total operating expenses | $12.6M (Q2); $25.5M (H1) | Consistent with expectations as the company increased investment in regulatory, quality, and pre-commercial planning ahead of a potential launch. |
| Net loss | $12.7M (Q2); $25.5M (H1) | Reflects continued clinical-stage, pre-revenue operating spend on regulatory and early-commercial initiatives. |
| Financing / capital raised | $45M offering + $4.3M over-allotment (~$49M gross) | June underwritten public offering of common stock and warrants met with strong support from existing and new investors. |
| NDA regulatory progress | Submitted June 2025 | First indication (smoking cessation); Day 74 acceptance letter expected mid-September, with a 120-day safety update to follow in October. |
| ORCA-OL long-term safety milestone | 290 completed 1 year (end of July) | Exceeded FDA's 100+ one-year-exposure request; safety profile consistent with six-month/one-year expectations per the Data Safety Monitoring Committee, with no new or unique signals. |
Earnings Call Themes & Trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Regulatory pathway (NDA / PDUFA / priority review / CNPV voucher) | — | NDA submitted in June; normal back-and-forth with the FDA underway; Day 74 acceptance letter expected mid-September to set the PDUFA date; standard review anticipated, with priority review and the new Commissioner's National Priority Voucher both requested but not viewed as likely. | — |
| Commercial launch readiness with Omnicom (availability, access, awareness) | — | All seven Omnicom agencies engaged and operational; building a launch roadmap and AI-enabled commercial platform; contracted Fourth 3PL, submitted home-state licensing, hired a VP of Market Access, and plans a Q4 pre-approval information exchange with payers ahead of a potential 2026 launch. | — |
| Reframing nicotine dependence as a treatable medical condition | — | Management aims to change the narrative to treat nicotine dependence as a medical condition (analogous to how GLP-1s reframed obesity), noting 29 million Americans smoke, over 15 million try to quit each year with poor success, and more than $600 billion in annual U.S. costs. | — |
| Pricing strategy | — | Cytisinicline is positioned as a branded product at a premium price relative to generic Chantix, differentiated by its profile; payers so far are not in disagreement with that positioning. | — |
| ORCA-OL open-label data value | — | Database lock targeted by year-end with publications/conference presentations in 2026; management sees strong value in one-year tolerability data (in line with phase III) and is keenly interested in the long-term efficacy secondary endpoint. | — |
| Synthetic cytisinicline and partnering / comorbidity expansion | — | Work on a synthetic version and potential partnering (including comorbid conditions such as COPD) continues but was deprioritized behind the NDA submission; management expects to advance those discussions now that the NDA is filed, with a platform that can also target specialists ('the ifs') beyond primary care. | — |
Q&A Summary
Thomas Flaten (Lake Street Capital) asked Cindy Jacobs whether the 120-day safety update would include only 100 patients or the full ~290 now available.
Jacobs said Achieve will submit all subjects from the database cut that occurred in June — more than 100, but not the full 290 (or the 200+) currently available.
Thomas Flaten (Lake Street Capital) asked Rick Stewart how to think about the commercial-spending ramp ahead of a late-2026 launch — whether it is fully approval-dependent or begins in the first half of next year.
Stewart said the ramp will be incremental and disciplined: pre-commercial investment must occur before approval, spending will increase over the coming quarters once the NDA is accepted (but not excessively), with a larger increase upon approval.
Thomas Flaten (Lake Street Capital) asked Jaime Xinos whether a premium price relative to generic Chantix is achievable or whether pricing should be closer to the generic.
Xinos said Achieve views cytisinicline as a branded product warranting a premium price given its differentiated profile, and that payers they have engaged are not in disagreement with that positioning.
John Vandermosten (Zacks) asked Jaime Xinos to walk through the initial provider-contact methods (email, social) and how outreach would escalate based on response.
Xinos said the channel mix is still to be determined and will be tailored to individual physician needs — meeting them where they are across social, email, in-person reps where access is strong, and virtual reps — informed by the ongoing targeting exercise.
Gary Nachman (Raymond James) asked Cindy Jacobs whether the 12-month safety profile for the 290 patients is consistent with the six-month data, how it will be released, and whether there is FDA back-and-forth before the Day 74 acceptance letter, plus the odds of priority review.
Jacobs said the 120-day update will be submitted in October; the Data Safety Monitoring Committee has seen no different or unique safety signals and the data are consistent with six-month/one-year expectations; back-and-forth with the FDA is normal and ongoing; a standard review is anticipated, though priority review and the new Commissioner's National Priority Voucher have both been requested (neither viewed as likely).
Gary Nachman (Raymond James) asked Jaime Xinos what work is underway with Omnicom now and whether unbranded marketing to physicians makes sense pre-approval.
Xinos said all seven Omnicom agencies are engaged and operational, building the launch roadmap and AI-enabled commercial platform; early awareness efforts focus on restarting and elevating the conversation and reframing nicotine dependence as a medical condition, with product-specific work reserved for closer to launch so spend can be tied to prescribing.
Gary Nachman (Raymond James) asked Rick Stewart for updates on the synthetic version of cytisinicline and any partnership discussions, including comorbid conditions like COPD.
Stewart said work on the synthetic continues but focus has been on a successful NDA submission; the same applies to partnering, and now that the NDA is filed the company can begin to advance those discussions further.
Justin Walsh (Jones Trading) asked whether the Omnicom partnership would affect potential discussions with more traditional pharma partners.
Stewart said it is complementary — Omnicom sits at the center while other, more traditional routes can be built out, and the company will keep flexibility to deploy the right resources at the right time; Xinos added that Omnicom's track record (100+ launches over three years with Merck, J&J, Novartis, AbbVie and others) adds credibility that Achieve will have a complete launch package.
Boris Tolkachev (Freedom) asked whether to expect clinical development roadmap updates before year-end and whether Achieve would share interim ORCA-OL results ahead of full publication.
Jacobs said the full ORCA-OL database will be completed by the end of this year (it is the only ongoing trial), with publications and conference presentations targeted for 2026 (potentially by Q2); Stewart added that the one-year open-label data show strong tolerability in line with the phase III trials, and management is very interested in the long-term efficacy secondary endpoint.
More on Achieve Life Sciences, Inc.
Reported 2025-08-07 · figures from the Achieve Life Sciences, Inc. Q2 2025 earnings call.
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