Achieve Life Sciences (ACHV) Q2 2026 earnings summary

Executive summary

• Focused on developing and commercializing cytisinicline for nicotine dependence, with no approved products or revenue to date.

• Closed a private placement of up to $354 million, with $180 million upfront and up to $174 million from milestone-based warrants tied to FDA approval.

• Received FDA Complete Response Letter (CRL) in June 2026 due to manufacturing issues at a third-party facility, not related to clinical efficacy or safety.

• Transitioned manufacturing to Adare Pharma Solutions and plan to resubmit NDA in Q4 2026, targeting potential approval in H1 2027.

• Leadership transition: Andrew D. Goldberg, MD appointed CEO in April 2026, with new senior commercial, CMC, and quality leaders, and six new board members.

Financial highlights

• Net loss of $84.9 million for the six months ended June 30, 2026, including a $48.7 million non-cash charge from warrant liabilities.

• Operating expenses increased to $28.9 million for the six months ended June 30, 2026.

• Cash, cash equivalents, and marketable securities totaled $187.3 million as of June 30, 2026.

• April 2026 private placement raised $168.2 million net; June 2025 public offering raised $41.2 million net.

• Net loss was $74.8 million for Q2 2026.

Outlook and guidance

• NDA resubmission for cytisinicline planned for Q4 2026, with potential FDA approval and U.S. commercial launch in H1 2027.

• Proceeds from the private placement will fund the ORCA-V2 Phase 3 trial, commercialization, and general corporate purposes.

• Ongoing investment in commercial infrastructure and market research to support launch.

• Continued focus on expanding cytisinicline indications, including for vaping cessation.