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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