Skye Bioscience, Inc. Q1 FY2025 earnings call

• Completed enrollment in Phase 2a CBeyond Trial ahead of schedule and extended study to 52 weeks for longer-term safety, tolerability, and efficacy data. • Generated preclinical data validating Nimacimab as a weight loss therapy, showing potential for durable weight loss with fewer safety concerns. • CSO Chris Twitty discussed preclinical studies highlighting Nimacimab's differentiated mechanism vs small molecules, including allosteric binding and additive weight loss with incretin mimetics. • CFO Kaitlyn Arsenault discussed financials, tariff impacts on manufacturing, and monitoring supply chain developments.

As of March 31, 2025, cash and cash equivalents and short-term investments totaled $59.2 million. Research and development expenses for the quarter were $7.2 million compared to $1.9 million in the same period of 2024. General and administrative expenses were $4.6 million versus $4.2 million in the prior year. Net loss for the quarter was $11.1 million compared to $5 million in the same period of 2024.

• Expect to report top-line weight loss data from 26-week primary analysis of CBeyond in late Q3 or early Q4. • Confident in moving forward with next stages of Nimacimab's development despite regulatory uncertainty.

• Regulatory uncertainty with potential shifts in drug pricing policy and unclear federal healthcare leadership. • Tariff pressures on pharmaceutical manufacturing, monitoring impact on supply chain and raw materials. • FDA and NIH transitions raising questions about balancing innovation and regulatory oversight.

Q: In terms of preclinical data, what can we expect at ECO and ADA?

A: At ECO, will present data on peripheral vs central activity of CB1 inhibitors. At ADA, will show in-depth preclinical data including biomarker and combination data.

Q: Do investors now grasp the difference between Nimacimab and Monlunabant?

A: Believe Street is better equipped with information, and combination potential is evident from preclinical data.

Q: Findings from DIO model on body composition and lean muscle mass preservation?

A: Nimacimab shows significant fat mass reduction with lean mass preservation, additive effect with tirzepatide.

Q: Safety reviews and neuropsychiatric AEs?

A: DMC reviews quarterly with no safety concerns, neuropsychiatric events reported as adverse events of special interest.

Q: Incremental benefit of extending CBeyond study to 52 weeks?

A: Allows broader safety, tolerability data and helps refine PK/PD models for Phase 2b study.

Q: Discussions with FDA on protocol amendment?

A: Submitted amendment, FDA requested minor clarifications, expect to resolve and start rolling patients into extension.