Thu, Mar 20, 8:10 PM (31 days ago)
Skye Bioscience, Inc. (SKYE) is a clinical-stage biotechnology company focused on developing next-generation molecules that modulate G-protein-coupled receptors (GPCRs) to treat obesity, overweight, and related conditions. The company's lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 (CB1), which is administered as a subcutaneous injectable for the treatment of obesity and overweight. Skye Bioscience commenced a Phase 2a clinical trial, CBeyond™, for nimacimab in August 2024, which includes 136 patients and 16 clinical trial sites, with an exploratory combination arm with a GLP-1 receptor agonist. The trial is 100% enrolled, and the company expects to provide topline data near the end of the third quarter or the beginning of the fourth quarter of 2025. The company's financial performance for the year ended December 31, 2024, showed a net loss of $26,567,123 and an accumulated deficit of $130,949,672. Research and development expenses were $18,701,694, primarily related to the Phase 2a clinical trial of nimacimab for obesity and manufacturing activities. General and administrative expenses were $17,725,741, driven by increased headcount, stock-based compensation, and legal and professional fees. The company's cash and cash equivalents as of December 31, 2024, were $68,415,741, with a cash runway that excludes the Phase 2b clinical study or manufacturing activities necessary to supply a Phase 3 clinical study. Skye Bioscience has a strategic overview focused on advancing nimacimab through clinical development, expanding its clinical utility, evaluating combination approaches, pursuing strategic partnerships, and developing next-generation GPCR-targeting molecules. The company faces several risk factors, including dependence on third-party manufacturers, limited operating history, substantial additional financing requirements, and the inherent risks of clinical drug development. The company's future outlook is contingent on the success of its clinical trials, regulatory approvals, and strategic partnerships.