Skye Bioscience (SKYE) Corporate presentation summary

Strategic positioning and market opportunity

• Nimacimab is positioned as a complementary, scalable add-on to GLP-1 therapies, targeting patients who need deeper or more durable weight loss or are intolerant to current treatments.

• The obesity market is rapidly expanding, with significant unmet needs among GLP-1 experienced patients who do not achieve sufficient weight loss or cannot tolerate existing drugs.

• Patent expirations for semaglutide in major markets from 2026 create opportunities for affordable combination therapies with nimacimab.

• Pricing strategy aims for a competitive out-of-pocket cost ($274/month) and a total combination cost with generic semaglutide under $300/month.

Clinical development and efficacy

• Nimacimab is a peripherally-restricted CB1-inhibiting antibody, designed to avoid neuropsychiatric side effects seen with small-molecule CB1 inhibitors.

• Combination of nimacimab and semaglutide in the CBeyond Phase 2a trial showed 22.3% mean weight loss at 52 weeks, with no plateau and improved body composition.

• The combination achieved a 3.0% incremental weight loss over semaglutide alone at 26 weeks and demonstrated favorable tolerability.

• No neuropsychiatric signals or additive GI burden were observed in the combination arm.

• Higher-dose expansion studies are underway to optimize exposure and efficacy.

Mechanism of action and differentiation

• Nimacimab acts as a negative allosteric modulator of peripheral CB1, improving energy metabolism, glycemic control, lipid metabolism, and reducing inflammation.

• Demonstrates minimal brain penetration, supporting a wide safety margin compared to small-molecule CB1 inhibitors.

• Maintains potency in the presence of endogenous agonists and shows similar or better efficacy than small molecules in preclinical assays.