In This Article:
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Cash, Cash Equivalents, and Marketable Securities: $23.2 million as of March 31, 2025.
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Total Operating Expenses: $12.9 million for the first quarter of 2025.
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Net Loss: $12.8 million for the first quarter of 2025.
Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Achieve Life Sciences Inc (NASDAQ:ACHV) is on track to submit the NDA for cytisinicline next month, marking a significant milestone.
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Cytisinicline has shown excellent efficacy and tolerability in helping patients quit smoking and vaping, with promising results from the ORCA-3 clinical trial published in JAMA Internal Medicine.
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The ORCA-OL open-label study has over 100 patients with the FDA's required 1-year exposure to cytisinicline, demonstrating strong patient retention and tolerability.
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The company has convened a Scientific Advisory Board with leading experts, highlighting the excitement and potential of cytisinicline in treating nicotine dependence.
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Achieve Life Sciences Inc (NASDAQ:ACHV) has a strong cash position of $23.2 million as of March 31, 2025, and is committed to financial discipline to support key priorities.
Negative Points
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Achieve Life Sciences Inc (NASDAQ:ACHV) reported a net loss of $12.8 million for the first quarter of 2025, reflecting high operating expenses.
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The company faces the challenge of launching cytisinicline in a market that has not seen a new nicotine dependence drug in nearly 20 years.
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There is uncertainty regarding the exact timing of the commercial launch post-NDA approval, which could impact revenue projections.
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Achieve Life Sciences Inc (NASDAQ:ACHV) is still in the process of finalizing its pricing and payer strategy, which could affect market access and reimbursement.
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The company has not yet secured strategic partnerships for potential comorbid COPD studies, which could provide additional non-dilutive capital.
Q & A Highlights
Q: How long before we see the full safety data from the long-term study, and how will it be presented? Also, what were some key takeaways from the Scientific Advisory Board (SAB) meeting? A: Cindy Jacobs, President and Chief Medical Officer, stated that most subjects in the open-label study will have completed over 6 months of treatment by June to September. The data will be compiled and presented after the NDA submission and the 120-day safety data submission in October. The SAB meeting highlighted potential applications for cytisinicline, including hospital settings, due to its lack of nausea side effects. Richard Stewart, CEO, noted the enthusiasm from key opinion leaders about the drug's potential impact on nicotine dependence.