Skye Bioscience Inc
NASDAQ:SKYE
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Skye Bioscience Inc
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Skye Bioscience Inc
Skye Bioscience, Inc. is a biopharmaceutical company, which engages in the discovery, development and commercialization of cannabinoid-based therapeutics. The company is headquartered in San Diego, California and currently employs 9 full-time employees. The company went IPO on 2014-02-24. The Company’s products programs include THCVHS and CBDVHS. The firm's lead candidate, THCVHS, is a prodrug of tetrahydrocannabinol (THC), is a topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT). The company chemically modifies THC to create a unique synthetic molecule with the intent to realize the known positive effects of THC. Its molecule enables enhanced local delivery in the eye, reduced systemic side effects, and the potential for neuroprotection for the treatment of ocular diseases. CBDVHS is a proprietary analog of cannabidiol (CBD) that has demonstrated biological activity that is both pharmacologically and therapeutically distinct from CBD in various preclinical models.
Skye Bioscience, Inc. is a biopharmaceutical company, which engages in the discovery, development and commercialization of cannabinoid-based therapeutics. The company is headquartered in San Diego, California and currently employs 9 full-time employees. The company went IPO on 2014-02-24. The Company’s products programs include THCVHS and CBDVHS. The firm's lead candidate, THCVHS, is a prodrug of tetrahydrocannabinol (THC), is a topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT). The company chemically modifies THC to create a unique synthetic molecule with the intent to realize the known positive effects of THC. Its molecule enables enhanced local delivery in the eye, reduced systemic side effects, and the potential for neuroprotection for the treatment of ocular diseases. CBDVHS is a proprietary analog of cannabidiol (CBD) that has demonstrated biological activity that is both pharmacologically and therapeutically distinct from CBD in various preclinical models.
Signal: Nimacimab plus semaglutide produced additive weight loss vs semaglutide alone (3% incremental at 26 weeks) and reached 22.3% mean weight loss in the 52-week combination extension.
Dosing issue: Management says the modest monotherapy result at 200 mg weekly is an exposure problem, not a mechanism failure — 200 mg yields ~7x IC90 in serum but underexposes peripheral tissues.
Dose response plan: CBeyond Part C will add 400 mg IV and 600 mg IV weekly cohorts (randomized 3:1, 16 weeks) to rapidly generate higher-exposure PK and safety data to inform Phase IIb dose selection.
CNS safety: Biodistribution and nonclinical translation indicate minimal brain exposure (brain:serum ~0.01%), and no nimacimab-associated neuropsychiatric signal through 52 weeks in the current data.
Subcutaneous path: Company is developing a high-concentration formulation (up to 200 mg/mL) and collaborating with Halozyme (ENHANZE) to enable high-volume subcutaneous dosing; ENHANZE mix-and-deliver expected for Phase IIb.
Durability signal: Off-treatment follow-up shows the combination group regained 17.8% of weight over 13 weeks versus 38.7% for semaglutide alone, with fat-mass loss largely maintained in the combination arm.
Platform upside: Early antibody–peptide conjugate (APC) data show unimolecular constructs can reproduce combination-like efficacy, supporting a longer-term multi-mechanism biologics platform.
Runway and milestones: Cash was $25.7 million at year-end 2025 and management expects runway into Q4 2026; top-line data from the expansion study and Phase IIb design expected by Q4 2026.
