The following is a summary of the Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript:
Financial Performance:
Achieve Life Sciences reported a net loss of $12.5 million for Q3 2024, compared to a net loss of $7.1 million in the same quarter the previous year.
The company's cash, cash equivalents, restricted cash, and short-term investments as of September 30, 2024, stood at $42.9 million, down from $61.3 million the previous quarter.
Achieve successfully completed a debt refinancing agreement with SVB, securing up to $20 million, split across three tranches, to support future activities including potential NDA submission.
Business Progress:
Achieve Life Sciences received FDA breakthrough therapy designation for cytisinicline for e-cigarette or vaping cessation.
The company is preparing for NDA submission for smoking cessation, targeting Q2 2025, and plans to commence a Phase 3 clinical trial for vaping cessation by Q3 2025.
Successfully enrolled 479 participants in the ORCA-OL safety trial for cytisinicline, completing enrollment ahead of expectations.
Achieve focuses on advancing cytisinicline as a promising treatment for nicotine dependence, supported by digital and innovative commercial strategies for market launch.
Opportunities:
Achieve Life Sciences is gearing up for the commercial launch of cytisinicline, capitalizing on the significant unmet need in smoking and vaping cessation.
The breakthrough therapy designation received for vaping cessation allows for enhanced interaction with FDA, potentially accelerating cytisinicline's approval and market entry.
Planned expansion into vaping cessation and exploration of adolescent and possibly nicotine pouch use cases provide multiple avenues for growth.
Risks:
The continued elevation of operating expenses as Achieve progresses with its ORCA-OL study and prepares for NDA submission and commercial rollout poses a financial strain.
The potential for high patient discontinuation rates in long-term trials could impact study outcomes and regulatory approval paths.
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