0001193125-26-218175
SEC filingAchieve Life Sciences reported Q1 2026 financial results, appointed new CEO and board members, and closed a $354 million private placement to fund cytisinicline development.
Achieve Life Sciences reported first quarter 2026 financial results, with total operating expenses of $10.5 million (down from $12.9 million in Q1 2025) and a net loss of $10.2 million ($0.19 per share) compared to a net loss of $12.8 million ($0.37 per share) in the prior year period. The reduction in expenses was driven by lower research and development costs ($3.3 million vs. $7.1 million), partially offset by higher general and administrative expenses ($7.2 million vs. $5.8 million). As of March 31, 2026, the company held $29.3 million in cash, cash equivalents, and marketable securities, not including approximately $168.6 million in net proceeds from the recently closed private placement.
The company highlighted several key developments. It closed a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone-based warrants exercisable upon FDA approval of cytisinicline. Proceeds will fund the ORCA-V2 Phase 3 trial for e-cigarette cessation, commercialization activities, and working capital. The company also appointed Andrew D. Goldberg as CEO and board member, and added three new directors: Christopher Martin (appointed May 11, 2026 per Frazier Life Sciences designation), Lucian Iancovici (who will become chairman on June 8, 2026), and Aaron E. Royston. Thomas King will resign as chairman effective June 8, 2026, and Jaime Xinos will depart as Chief Commercial Officer on May 31, 2026.
On the regulatory front, Achieve expects a Complete Response Letter from the FDA on or before June 20, 2026, due to manufacturing issues at a prior third-party facility. The company plans to resubmit its NDA in Q4 2026 with new manufacturing partner Adare Pharma Solutions, targeting a U.S. commercial launch in the first half of 2027. The company also presented positive data at SRNT 2026, including a pooled analysis showing 12-week cytisinicline significantly increased continuous abstinence versus placebo in patients who had failed prior therapies (32.4% vs. 6.0%; OR 7.5).