Skye Bioscience (SKYE) UBS Global Healthcare Conference summary

Strategic focus and clinical development

• Lead asset is a peripherally restricted CB1-inhibiting antibody, nimacimab, in phase 2 for obesity, aiming to address gaps left by GLP-1s and other incretins.

• Nimacimab is designed to avoid neuropsychiatric side effects by not crossing the blood-brain barrier, differentiating it from earlier CB1-targeting drugs.

• The phase 2 trial includes monotherapy and combination arms with semaglutide (Wegovy), targeting 8% weight loss at 26 weeks and assessing lean mass preservation.

• Interim data readout is expected in Q2 2025, with robust enrollment across 18 U.S. sites and no anticipated delays.

• Manufacturing is being scaled to support future trials, with new drug supply and autoinjector units planned for 2025.

Mechanism of action and differentiation

• Nimacimab acts as a negative allosteric modulator, binding away from the orthosteric pocket, enabling a larger therapeutic window and peripheral selectivity.

• The antibody's Fc region is modified for enhanced peripheral restriction, making it more selective than small molecules.

• Preclinical and phase 1 data show peripheral CB1 inhibition drives weight loss and improves metabolic markers without neuropsychiatric adverse events.

• The mechanism supports lean mass preservation, addressing a key unmet need in the anti-obesity market.

• Combination with GLP-1s is expected to provide additive effects and potentially allow lower GLP-1 dosing.

Market positioning and future plans

• Nimacimab targets the non-incretin obesity space, aiming to complement existing therapies and fill safety and efficacy gaps.

• The trial is designed to answer key questions on efficacy, safety, and lean mass preservation, with a minimum efficacy threshold of 5% weight loss for further development.

• Dosing strategies are being optimized for monthly or bi-monthly administration, with ongoing evaluation of higher concentrations.

• The asset's IP extends to 2035/2036, with active life cycle management and exploration of multi-target combinations.

• Cash runway extends to mid-2027, supporting clinical and preclinical programs.