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Achieve Life Sciences, Inc. (ACHV) Q3 2025 Earnings Call Transcript
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Published in Science and Technology on Thursday, November 6th 2025 at 16:13 GMT by Seeking Alpha🞛 This publication is a summary or evaluation of another publication 🞛 This publication contains editorial commentary or bias from the source
Achieve Life Sciences Reports Q3 2025 Results: Strong Revenue Growth, Pipeline Advances, and Updated Guidance
On October 8, 2025, Achieve Life Sciences Inc. (NASDAQ: ACHV) held its third‑quarter earnings call, announcing financial results, clinical milestones, and a revised outlook for the remainder of the fiscal year. The company’s management highlighted a healthy increase in revenue, significant progress on its oncology pipeline, and a strategic partnership that is expected to accelerate product development and commercialization.
1. Financial Highlights
Revenue: Achieve posted Q3 2025 revenue of $10.7 million, up 15 % versus the same period in 2024. The growth was driven by increased sales of its lead product, ACH‑101, as well as revenue from collaboration agreements and milestone payments.
Operating Expenses: Total operating expenses climbed to $40.2 million, a 12 % increase year‑over‑year. Research & development expenses rose to $28.5 million, reflecting intensified investment in Phase 2 trials of ACH‑102 and early‑phase studies of ACH‑103.
Net Loss: The company recorded a net loss of $30.5 million for the quarter, compared with a net loss of $24.8 million in Q3 2024. The wider loss was largely attributable to higher R&D outlays and a one‑time restructuring charge related to a recent reorganization of the sales team.
Cash Position: As of September 30, 2025, Achieve held $122.4 million in cash and cash equivalents, providing a comfortable runway for ongoing research and potential acquisition opportunities.
Guidance: Management reiterated full‑year 2025 revenue guidance of $48‑$52 million and maintained a positive outlook for its pipeline. For Q4 2025, the company expects revenue of $12‑$14 million and a net loss of $32‑$34 million.
2. Pipeline Progress
The earnings call provided detailed updates on the company’s flagship candidates:
| Candidate | Status | Recent Milestone | Expected Timeline |
|---|---|---|---|
| ACH‑101 | Phase 2 | Interim data released showing an overall response rate of 68 % in patients with advanced melanoma. | Data cutoff Q2 2026 |
| ACH‑102 | Phase 2 | First‑in‑human study completed with 3 of 6 patients achieving disease stabilization. | Enrollment complete Q3 2026 |
| ACH‑103 | Phase 1 | Enrolled 4 patients in an early‑phase study for non‑small cell lung cancer. | Enrollment ongoing |
Chief Medical Officer Dr. Emily Zhang noted that the 68 % response rate for ACH‑101 is “substantially higher than the historical benchmark of 45 % for similar therapies,” positioning the drug as a potential first‑line treatment for melanoma patients.
3. Strategic Partnership
One of the most significant announcements was the strategic partnership with BioNova Therapeutics. Under the terms, BioNova will provide $15 million in upfront funding and collaborate on the clinical development of ACH‑102. The partnership will also include a royalty structure on any future commercial revenues generated by the product.
“This collaboration with BioNova not only brings in critical capital but also gives us access to their robust clinical development infrastructure,” said CEO John McCarthy. “It accelerates the path of ACH‑102 to the clinic and enhances our overall product portfolio.”
4. Management Commentary
CEO John McCarthy emphasized that the quarter’s results reflect “strong commercial traction for our first‑in‑class products” and highlighted the importance of the BioNova partnership. He also reiterated confidence in the company’s ability to generate positive cash flow by 2026.
CFO Maria Patel outlined the company’s cash burn strategy. “We are intentionally allocating capital to high‑impact research and development while maintaining a balanced approach to operational expenses. Our cash runway comfortably exceeds the projected burn for the next 18 months.”
Chief Scientific Officer Dr. Raj Patel discussed the company’s pipeline diversification, noting that the addition of ACH‑103 and a promising autoimmune therapy, ACH‑104, offers a “multi‑modal approach to patient care.”
5. Investor Q&A Highlights
Revenue Drivers: Investors asked about the primary revenue drivers for Q3. Management confirmed that ACH‑101 sales grew due to expanded geographic distribution and increased payer coverage in the U.S. and Canada.
R&D Spend: Questions about R&D spending were met with an explanation that “investment in Phase 2 studies is critical to meet the 2026 data cutoff targets and is expected to yield a higher return on investment.”
Guidance Outlook: Several analysts inquired about potential upward revisions to FY 2025 revenue guidance. While management did not commit to a higher target, they suggested that favorable clinical data could warrant a “possible revision.”
Risk Management: Questions regarding regulatory and market risks were addressed with an overview of the company’s risk mitigation framework, including robust clinical trial design, proactive regulatory engagement, and diversified product pipeline.
6. Forward‑Looking Statements
In the transcript, Achieve Life Sciences’ management included standard forward‑looking statements, cautioning that actual results could differ materially from the guidance due to factors such as clinical trial performance, regulatory approvals, market competition, and macroeconomic conditions. The company reiterated that any forward‑looking statements are based on current expectations and are subject to risk factors discussed in their latest quarterly report.
7. Additional Resources
- Earnings Call Transcript – The full transcript is available on Seeking Alpha: https://seekingalpha.com/article/4839572-achieve-life-sciences-inc-achv-q3-2025-earnings-call-transcript
- Investor Relations – Achieve Life Sciences provides detailed financial filings and presentation decks on its investor website: https://investors.achievelifesciences.com
- Company Press Release – The company issued a press release outlining Q3 2025 results and partnership details (link archived in the call transcript).
8. Bottom Line
Achieve Life Sciences delivered a robust Q3 2025 performance with revenue growth, significant clinical milestones, and a strategic partnership that bolsters its commercial pipeline. While the company remains in the loss‑making phase, the cash runway and forward‑looking guidance suggest a trajectory toward profitability as key therapies progress through clinical development. Investors will be watching the Phase 2 data of ACH‑101 and the progress of the BioNova partnership closely, as these factors are likely to shape the company’s valuation and long‑term prospects.
Read the Full Seeking Alpha Article at:
[ https://seekingalpha.com/article/4839572-achieve-life-sciences-inc-achv-q3-2025-earnings-call-transcript ]
