Skye Bioscience (SKYE) Stifel 2024 Healthcare Conference summary

Strategic pipeline and clinical development

• Focused on a comprehensive metabolic pipeline led by nimacimab, now in Phase 2 studies.

• Pipeline targets GPCR and biologic mechanisms, emphasizing differentiated CB1 inhibition in the non-incretin obesity space.

• Leadership team expanded with expertise in metabolic diseases, clinical development, and CMC.

• Product profile aims for less frequent dosing, with a goal to move from weekly to monthly injections.

• Aggressive clinical roadmap with interim data expected in Q2 2025 and top-line data to follow.

CB1 inhibition and safety differentiation

• Emphasis on peripheral CB1 inhibition to avoid neuropsychiatric side effects seen with central CB1 inhibitors like rimonabant.

• Nimacimab is a negative allosteric modulator antibody, designed to stay out of the brain and provide a large therapeutic window.

• Preclinical and clinical data support peripheral sufficiency for weight loss without central activity.

• Safety is prioritized, aiming to overcome historical limitations of CB1 inhibitors.

• Interim data will focus on safety and top-line weight loss outcomes.

Clinical trial design and expectations

• Current trial includes both monotherapy and combination arms with GLP-1, targeting anti-obesity medication-naive patients.

• Interim readout in Q2 2025 will include 26-week data from about 60 patients per arm, focusing on weight loss and safety.

• Expectation of additive benefit in combination therapy, with potential for improved tolerability and lean mass preservation.

• Interim data is anticipated to be a strong barometer for the full data set expected in Q4 2025.

• Additional follow-up data, including durability, will be available later in the year.