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 2 trial, named CBeyondTM, includes robust endpoints such as weight loss, body composition, safety, and metabolic markers. Interim data is expected by Q2 2025, with final top-line results by Q4 2025, offering a critical near-term potential validation of its therapeutic potential.
  • 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. Preclinical and Phase 1 data shows virtually undetectable CNS accumulation and no neuropsychiatric adverse events, establishing it as the safest option in the CB1 inhibition class with the potential of delivering competitive weight loss efficacy and an improved safety profile (i.e. tolerability, dosing etc.) when compared to other CB1 inhibitors and approved weight loss drugs treatments using other mechanisms of action.
  • 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 address key issues like gastrointestinal tolerability, patient dropouts, and non-responders, making it a potentially distinct therapy in this growing space.
  • Financial Strength and Execution Capability: Skye has raised over $107 million in the since mid-2023, securing funding through Q3 2027. Coupled with a highly experienced leadership team, the company is well-positioned to execute its clinical and commercial strategies, creating significant long-term value for investors.