Skye Bioscience, Inc. Q2 FY2025 earnings call

• Clinical Progress: Phase IIa CBeyond study advancing as planned, enrollment completed in February ahead of schedule, 26-week visit for last patient imminent, 26-week extension study underway with ~50% of original study patients eligible. Data Safety Monitoring Committee reviewed study 4 times with no recommendations. Top line results expected in late Q3/early Q4.
• R&D Foundation: Nimacimab is a peripherally restricted CB1 antibody with negligible brain penetration, allosteric noncompetitive inhibition. Preclinical data shows benefits in caloric restriction, glycemic control, lipid metabolism, and obesity-induced inflammation. New preclinical data shows nimacimab enhances tirzepatide efficacy, has durable weight loss post-treatment, and acts as maintenance therapy post-incretin treatment.
• Positioning in Obesity Landscape: Market opportunities in monotherapy for non-responsive/intolerant patients, combination partner to amplify efficacy/reduce incretin dose, and maintenance therapy for sustained weight loss with better tolerability. Addresses gaps in incretin-based therapies like high discontinuation rates, lean mass loss, and GI side effects.

In the second quarter ended June 30, 2025, research and development expenses were $14.3 million compared to $4.1 million for the same period in 2024. Cash and cash equivalents and short-term investments totaled $48.6 million. The increase in R&D expenses was primarily due to contract manufacturing, clinical trial costs for nimacimab, discovery research, and salaries/stock-based compensation. General and administrative expenses were $3.9 million in Q2 2025 vs $4.3 million in 2024, with decreases in general business and legal fees offset by increases in salaries, consulting, and investor relations costs.

• Top line clinical readout from CBeyond expected in late Q3/early Q4, including data from monotherapy and combo arms on placebo-adjusted weight loss, safety, body composition, and mechanistic biomarkers.
• Present Phase I SAD/MAD NAFLD data at EASD on September 19.
• Finalize Phase IIb protocol, advance CMC, initiate regulatory engagement and external planning for next phase studies post top line data.

Forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially, including risks related to clinical trial outcomes, regulatory approvals, and market acceptance of nimacimab.

Q: Regarding the independent board overseeing the trial, what's the protocol?

A: DMC meets quarterly, receives complete safety data including adverse events, serious adverse events, and AESIs; 4 reviews completed with no significant issues.

Q: Will the extension study have follow-up for durability? When will data be available?

A: Yes, will have 13-week follow-up; data from this part expected in first half of 2026