Here are five overarching elements of an investment thesis for an investor to consider in reviewing Skye Bioscience: 

  • Validated Target, Clinical Pipeline and Market Position: Skye is at the forefront of GPCR-based antibody therapies, with a focus on metabolic diseases. With our flagship drug, nimacimab, a CB1 inhibitor, we aim to redefine obesity treatment through sustainable weight loss and metabolic restoration, targeting the significant unmet needs of the obesity market that have not been fulfilled by approved GLP-1 receptor agonists and other incretin treatments.

  • Key Clinical Milestones/Inflection Points: Nimacimab's Phase 2a trial, CBeyondTM, includes robust endpoints such as weight loss, body composition, safety, and metabolic markers. Topline results from the 26-week initial clinical trial period were reported in October 2025. As a monotherapy, nimacimab did not meet its primary endpoint for weight loss. In combination with semaglutide, nimacimab achieved meaningful additional weight loss and other positive outcomes, compared to semaglutide alone, which are detailed in the press release. Data from a continuing 26-week extension of the P2a study, which is intended to achieve 52-week data, is expected to be reported in 2026.

  • Clear Differentiation in Safety and Efficacy: CB1 inhibition has been validated by prior clinical studies of small-molecule drugs in this class, showing the ability to drive clinically meaningful weight loss. These molecules, however, have also generated neuropsychiatric adverse events. As a differentiated molecule, a monoclonal antibody, nimacimab avoids neuropsychiatric side effects by focusing on highly-restricted peripheral CB1 inhibition. In the Phase 2a study 26-week topline data, no neuropsychiatric concerns were observed, with no increase in anxiety, insomnia, or depression resulting from treatment with nimacimab 200 mg as a monotherapy or in combination with semaglutide. Nimacimab 200 mg also demonstrated a clean safety profile as a monotherapy, with placebo-like tolerability. When combined with semaglutide, no increase in gastrointestinal (GI) adverse events were observed. These data establish nimacimab 200 mg as a potentially safe option in the CB1 inhibition class to potentially be combined with a GLP1 therapeutic in order to achieve an improved weight loss/tolerability outcome. Further assessment of nimacimab as a mono or combination therapy is ongoing.

  • Substantial Market Opportunity: Analysts have projected the future obesity market to exceed $100B in sales potential, with substantial gaps in current treatment options and patient segments with different treatment needs. Nimacimab may help address key issues like gastrointestinal tolerability, patient dropouts, and non-responders, making it a potentially distinct therapy in this growing space.

  • Execution Capability: With a highly experienced leadership team, the company is well-positioned to execute its clinical and business strategy, which is focused on creating long-term value for investors.