Achieve Life Sciences (ACHV) Q1 2026 earnings summary

Executive summary

• Appointed a new CEO with deep clinical and commercial experience, expanded the board, and reorganized commercial leadership to position for late-stage development and commercialization of cytisinicline for nicotine dependence.

• Mission focused on addressing the unmet need in nicotine dependence, with cytisinicline as a potential first-in-class therapy for both smoking and vaping cessation.

• No approved products or revenue to date; FDA accepted NDA for cytisinicline for smoking cessation, with Breakthrough Therapy designation and National Priority Voucher for vaping cessation.

• Acknowledgement of prior leadership and recent board expansion to strengthen governance and commercial execution.

Significant events and developments

• Closed a transformational private placement, raising $180 million upfront with up to $174 million in milestone-based warrants, totaling up to $354 million to fund clinical trials, commercialization, and general purposes.

• Leadership transition with new CEO and board appointments, and reorganization of commercial leadership for upcoming product launch.

• Transitioned manufacturing to U.S.-based Adare Pharma Solutions, completing technology transfer and first engineering batch to mitigate international supply risks.

• FDA manufacturing inspection issues led to anticipated NDA delay and planned resubmission.

• Published new scientific and clinical data supporting cytisinicline’s mechanism, efficacy, and tolerability.

Financial highlights

• Secured $180 million in upfront capital from private placement, with potential for an additional $174 million upon milestone achievements, netting $168.6 million in April 2026.

• Cash, cash equivalents, and marketable securities totaled $29.3 million as of March 31, 2026, before the April financing.

• Net loss for Q1 2026 was $10.2 million, improved from $12.8 million in Q1 2025.

• Basic and diluted net loss per share was $(0.19) in Q1 2026, compared to $(0.37) in Q1 2025.