Achieve Life Sciences ((ACHV)) has held its Q1 earnings call. Read on for the main highlights of the call.
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Achieve Life Sciences’ recent earnings call conveyed an optimistic sentiment, focusing on the company’s progress towards the New Drug Application (NDA) submission for cytisinicline. Despite reporting a net loss, the call highlighted significant milestones in clinical trials and robust financial management, with some caution regarding the timing of commercialization.
NDA Submission Imminent
Achieve Life Sciences is on the brink of a major milestone, with plans to submit the NDA for cytisinicline next month. This submission marks a crucial step forward for the company, underscoring its commitment to advancing its smoking cessation treatment.
ORCA-OL Trial Progress
The ORCA-OL trial has shown promising results, with over 100 patients having one-year exposure to cytisinicline, as required by the FDA. Impressively, 75% of participants remain on treatment, highlighting the drug’s tolerability and potential efficacy in aiding smoking cessation.
Publication and Recognition
The results of the ORCA-3 trial were published in JAMA Internal Medicine, bringing significant recognition to cytisinicline’s efficacy and tolerability. This publication is a testament to the drug’s potential impact on smoking cessation efforts.
Financial Management
Achieve ended the quarter with $23.2 million in cash, demonstrating strong financial discipline. This financial prudence is crucial as the company prepares for the NDA submission and potential future launch of cytisinicline.
Strong Advisory Support
A recent meeting with the Scientific Advisory Board, including experts from renowned institutions, showed significant enthusiasm for cytisinicline. This support is vital as Achieve moves closer to its NDA submission.
Net Loss Reported
Achieve reported a net loss of $12.8 million for the first quarter of 2025. While this is a notable figure, the company’s focus remains on advancing its clinical programs and preparing for future opportunities.
Uncertainty in Commercialization Timeline
While Achieve aims for a 2026 launch of cytisinicline, there remains uncertainty about the exact timing of commercialization post-approval. This uncertainty reflects the challenges inherent in bringing new treatments to market.
Forward-Looking Guidance
During the earnings call, Achieve Life Sciences provided key guidance on its progress, particularly emphasizing the upcoming NDA submission for cytisinicline, projected for June 2025. The company is targeting approval within 12 months post-submission. The ORCA-OL trial has shown encouraging results, with strong adherence among participants. Financially, Achieve is focused on managing resources efficiently to extend its cash runway while preparing for a potential commercial launch in 2026.
In summary, Achieve Life Sciences’ earnings call presented an optimistic outlook, highlighting significant progress towards the NDA submission for cytisinicline. Despite a reported net loss, the company’s strategic focus on clinical milestones and financial management positions it well for future success, albeit with some uncertainty regarding commercialization timing.