GlobeNewswire·Aug 11, 2026, 8:30 AM ET

Achieve Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Updates

ACHV

Achieve Life Sciences closed a private placement of up to $354 million, consisting of $180 million upfront & up to $174 million from warrants exercisable prior to & up to 20 trading days following FDA approval.
The company anticipates potential FDA approval for cytisinicline in the first half of 2027, followed by a U.S. commercial launch.
On June 20, 2026, the FDA issued a Complete Response Letter citing cGMP observations from a prior third-party facility & incomplete labeling, while noting no deficiencies in clinical efficacy or safety.
Manufacturing transition for finished drug products is moving to U.S.-based Adare Pharma Solutions, with plans to resubmit the NDA in the fourth quarter of 2026.
Leadership changes include Andrew D. Goldberg joining as Chief Executive Officer & six new Board appointments bringing expertise in healthcare investing, finance, & clinical leadership.
Commercial buildout includes Mark Zappia as Senior Vice President, Commercial & Jim Willis as Vice President of Sales & Sales Enablement.
Senior CMC & quality appointments include Ronald Dadino as Senior Vice President, CMC & Supply Chain & Gloria Cosgrove as Senior Vice President, Global Quality.
52-week safety data from the ORCA-OL study showed no new safety signals among 475 participants.
Analysis of Phase 3 trials in participants with a cancer history showed cytisinicline was well tolerated with higher abstinence rates (24.4%) versus placebo (15.8%).
Proceeds from the capital raise will fund the ORCA-V2 Phase 3 trial, commercialization efforts, working capital, & general corporate purposes.
As of June 30, 2026, cash & equivalents totaled $187.3 million, while total operating expenses for the quarter were $18.4 million.
The company reported a net loss of $74.8 million for the quarter, including a $48.7 million non-cash charge related to warrant liability fair value changes.