Achieve Life Sciences (ACHV) Q4 2024 earnings summary

Executive summary

• Preparing to submit NDA for cytisinicline as a smoking cessation treatment by end of Q2 2025, with commercial launch targeted for Q3 2026.

• Achieved key milestones in 2024, including completion of long-term safety trial enrollment and breakthrough therapy designation for vaping cessation.

• Transitioning from a clinical-stage to a commercial-stage company, with all resources focused on NDA submission and launch readiness.

• Positive safety reviews from DSMC and new leadership appointments support commercialization strategy.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $34.4 million as of December 31, 2024, up from $15.6 million a year prior.

• Operating expenses for Q4 and full year 2024 were $12.2 million and $39.1 million, respectively.

• Net loss for Q4 and full year 2024 was $12.4 million and $39.8 million, respectively.

• Basic and diluted net loss per share was $(0.36) for Q4 2024 and $(1.24) for the year.

• 34,685,072 shares outstanding as of March 11, 2025.

Outlook and guidance

• NDA submission for cytisinicline on track for end of Q2 2025; commercial launch planned for Q3 2026.

• Phase 3 trial for vaping cessation (ORCA-V2) expected to initiate in first half of 2026, contingent on financing.

• Anticipates a gradual sales ramp post-launch due to time required for access and awareness.

• FDA granted Breakthrough Therapy designation for cytisinicline in vaping cessation.