Achieve Life Sciences reported a $12.11 million net loss
Achieve Life Sciences (ACHV) filed a 10-Q with the SEC on Nov 10, 2026, 4:12 pm ET. Source: the filing on SEC EDGAR.
Quarterly report, 5 new risk factors
- Form
- 10-Q
- Filed
- Importance
- Major
- Accession
- 0001193125-26-455463
- Net loss of $12.11 million for the three months ended Sep 30, 2026
- Diluted EPS of -$0.11 for the three months ended Sep 30, 2026
- Cash and equivalents of $59.74 million at Sep 30, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed since last quarter
5 new risk factors · 4 removed
Compared with the 10-Q for the period ended Jun 30, 2026.
| This filing | Previous | Change vs prior 10-Q | |
|---|---|---|---|
| Net income | −$12.11M | −$74.77M | +84% |
| Operating cash flow | −$8.36M | −$10.78M | +23% |
| Cash | $59.74M | $47.96M | +25% |
New risk factors (5)
- The FDA advised us that safety data on exposure beyond 12 weeks would be needed because it views smoking cessation drugs as products for chronic, repeated, and intermittent use. We reached agreement with the FDA that a single open-label study, ORCA-OL, would be sufficient to satisfy this requirement. ORCA-OL was…
- The FDA has also awarded us a CNPV for cytisinicline for vaping cessation. The CNPV is designed to provide enhanced communication with the FDA and an expedited review, but it must be used within two years of issuance. Based on our current development timeline, which includes completion of our Phase 3 ORCA-V2 trial…
- In April 2026, we appointed Andrew Goldberg, M.D. as our Chief Executive Officer and President, and in October 2026, we appointed Benjamin Halladay as our Chief Financial Officer. Any change in senior leadership inherently involves risks and uncertainties, including potential disruptions to our operations, strategic…
- Approval of a vaping cessation indication will depend substantially on the results of a single Phase 3 trial. We previously disclosed that the FDA had agreed on a Phase 3 trial design that, combined with our completed Phase 2 ORCA-V1 trial, would support a supplemental NDA for vaping cessation. As a result, if…
- • pricing cytisinicline at a sufficient price point, balancing a price that supports formulary and patient access against profitability;
Removed risk factors (4)
- The FDA advised us that long-term exposure data to assess for safety beyond 12 weeks would be needed to adequately assess safety risks given that the FDA views smoking cessation drugs as products for chronic, repeated, and intermittent use as patients may relapse and require subsequent courses of treatment over a…
- The FDA has also awarded us a CNPV for cytisinicline for vaping cessation. While the CNPV is designed to provide enhanced communications with the FDA and expedite its review of a therapy, we would still be required to commence the voucher process within the two-year time period set by the FDA, which will require…
- On April 18, 2026, we appointed Andrew Goldberg, MD as our new Chief Executive Officer and President, and as a member of our Board. While we believe this leadership change positions the Company for continued growth and execution of our strategic priorities, and while our former Chief Executive Officer will continue…
- • the inability to price cytisinicline at a sufficient price point to ensure appropriate insurance coverage and an attractive level of profitability;