Skye Bioscience's Q1 2025: Key Contradictions on Trial Extensions, Safety Issues, and Regulatory Interactions

Trial extension and data collection, safety and neuropsychiatric events, protocol amendment and FDA interaction, efficacy expectations and preclinical data confidence are the key contradictions discussed in Skye Bioscience's latest 2025Q1 earnings call.



Clinical Trial Progress and Data:
- Skye Biosciences completed enrollment in the Phase 2a CBeyond Trial ahead of schedule and extended the study to 52 weeks.
- The extension is expected to provide longer-term data on safety, tolerability, and efficacy, both as Monotherapy and in combination with GLP-1.
- This decision was driven by the need to collect more comprehensive data to support the potential of the drug's long-term weight loss benefits.

Preclinical Data and Mechanism Validation:
- Recent preclinical studies with nimacimab demonstrated significant weight loss in DIO models, surpassing 30% when combined with tirzepatide.
- This research highlighted the peripheral activity of nimacimab, differentiating it from small-molecule CB1 inhibitors and suggesting fewer neuropsychiatric side effects.
- The studies were aimed at validating nimacimab's unique mechanism as a CB1 inhibitor, which could lead to better clinical outcomes.

Financial and Operational Updates:
- Skye Biosciences reported $59.2 million in cash and cash equivalents as of March 31, 2025.
- The company's cash flow guidance remains intact, allowing for key clinical milestones through at least Q1 2027.
- This financial stability is attributed to disciplined execution and strategic planning, despite regulatory uncertainties.

Regulatory Strategy and Approval Planning:
- Skye aims to obtain FDA approval for nimacimab as a monotherapy, with potential future combination studies with incretins.
- The company is engaging with regulatory authorities to seek advice on a definitive dose-ranging Phase 2b study.
- This strategy is focused on refining the target product profile and ensuring nimacimab's potential as a viable treatment option in combination with other therapies.