Skye Bioscience (SKYE) Corporate presentation summary

Executive summary

• Developed a combination strategy using nimacimab and semaglutide to enhance weight loss and durability for obesity treatment, with a favorable tolerability profile and commercial scalability.

• Nimacimab acts as a peripherally-restricted CB1-inhibiting antibody, offering additive efficacy to GLP-1 therapies and a differentiated mechanism in a crowded market.

• Target product profile aims for +5-8% weight loss on top of incretin therapy, minimal increase in GI burden, and minimal weight regain after discontinuation.

Mechanism and clinical data

• Nimacimab blocks peripheral CB1, potentially reversing metabolic dysfunction, inflammation, and fibrosis.

• Demonstrates long half-life, exclusion from the brain, and functions as both antagonist and inverse agonist, maintaining safety and efficacy.

• Four mechanistic pillars: appetite hormone modulation, improved glycemic control, enhanced lipid metabolism, and reduced inflammation.

Clinical trial results

• In Phase 2a, nimacimab + semaglutide achieved 13% weight loss at 26 weeks and 22.3% at 52 weeks, outperforming semaglutide alone and historical data.

• Combination therapy showed lower post-treatment rebound (17.8% vs. 37.3% for semaglutide alone) and improved body composition, with increased fat loss by 37%.

• Safety profile was favorable, with no additive GI burden or neuropsychiatric adverse events.