Skye Bioscience, Inc. - SKYE STOCK NEWS

Skye Bioscience (OTCQB: SKYE) announces a delay in the production of its Phase 1 clinical trial material for SBI-100 Ophthalmic Emulsion due to a recently resolved cyber-attack and planned CMO maintenance. Production is rescheduled for early September, with Phase 1 study enrollment now expected in Q4 2022 and preliminary data in Q1 2023. Despite this delay, the company is advancing its Phase 2 clinical development plan, with the FDA allowing nonclinical toxicology data for IND application, which is not contingent on Phase 1 results. Phase 2 data could be reported by year-end 2023.

Skye Bioscience (OTCQB: SKYE) has announced new research collaborations with the University of Eastern Piedmont (UPO) in Italy and the Spanish Research Council (CSIC) to develop a library of cannabinoid derivatives aimed at modulating the endocannabinoid system. These partnerships focus on creating up to 100 novel molecules in the first year, targeting ophthalmic disorders. Skye aims to leverage these collaborations to strengthen its Cannabinoid Pharmaceutical Innovation Program and advance its lead drug candidate, SBI-100 Ophthalmic Emulsion, for treating glaucoma.

Skye Bioscience (OTCQB: SKYE) has announced a definitive agreement to acquire Emerald Health Therapeutics (CSE: EMH; OTCQB: EMHTF) through a share-for-share transaction expected to close in Q3 2022. Skye anticipates that this acquisition will enhance its funding for a Phase 2 clinical study of its lead therapeutic, SBI-100 Ophthalmic Emulsion, targeting glaucoma, planned for Q4 2022. Current Skye shareholders will own approximately 54% of the combined company, while former Emerald shareholders will own about 46%. The transaction requires shareholder and court approval.

Skye Bioscience announced promising preclinical results for its glaucoma treatment SBI-100, demonstrating superior efficacy over the standard care in a study published in the International Journal of Pharmaceutics. Formulated as a nanoemulsion with Carbopol® 940, SBI-100 showed a greater and longer-lasting reduction in intraocular pressure (IOP) than both latanoprost and timolol. With a maximum drop of 4.5 mmHg at 60 minutes and sustained effects for at least 480 minutes, this new formulation is aimed at transitioning to human trials soon. CEO Punit Dhillon expressed optimism for its clinical potential.

Skye Bioscience (OTCQB: SKYE) is advancing its lead product, SBI-100 Ophthalmic Emulsion, aimed at treating glaucoma. The company has partnered with CMAX Clinical Research to conduct a Phase 1 study, focusing on safety and pharmacokinetics in healthy volunteers. The trial will occur in Adelaide, Australia, with data expected by Q4 2022. SBI-100 OE shows promising results in preclinical studies, highlighting its potential to effectively lower intraocular pressure, a significant factor in glaucoma progression.

Skye Bioscience (OTCQB: SKYE) has partnered with Novotech Health Holdings to conduct a Phase 1 clinical study for its SBI-100 drug candidate aimed at treating glaucoma. This collaboration is expected to facilitate timely and cost-effective execution of the trial in Australia. The Phase 1 study is scheduled to begin in Q2 2022, with results anticipated in the latter half of the year. SBI-100 is a synthetic cannabinoid derivative designed to lower intraocular pressure, showing promising preclinical results—superior to existing glaucoma treatments.

Skye Bioscience (OTCQB: SKYE) announced the completion of a GLP nonclinical toxicology study for its SBI-100 ophthalmic nanoemulsion, a potential treatment for glaucoma. The study assessed ocular toxicity in rabbits, finding no adverse effects or histological changes. This positive outcome allows Skye to submit a clinical trial application to the Human Research Ethics Committee in Australia, aiming to initiate Phase 1 clinical trials in Q2 2022. SBI-100 is designed to provide a safer, localized delivery of cannabinoid therapy to reduce intraocular pressure, mitigating the risk of vision loss.

Skye Bioscience (OTCQB: SKYE) announced promising results from a preclinical study of its SBI-100 ophthalmic nanoemulsion, which suggests improved neuroprotective effects on retinal ganglion cells (RGCs) in glaucoma treatment. The study indicated a trend of better RGC function in treated rats compared to controls. While the structural evaluations showed no significant differences, the functional improvements warrant further investigation. Skye plans to begin its first-in-human study of SBI-100 in Q2 2022, focusing on addressing glaucoma's underlying neurodegenerative issues beyond intraocular pressure.

Skye Bioscience (OTCQB: SKYE) announced significant progress in developing its cannabinoid-based compound, SBI-100, targeting glaucoma. The company strengthened its leadership team and completed vital preclinical studies, demonstrating SBI-100's safety and efficacy. With a $7 million financing boost and a robust cash position of $11.1 million, Skye aims to commence its first-in-human Phase I study in H1 2022, expecting topline data by Q3 and a Phase II study by the end of the year. 2022 is set to be transformative as Skye advances its ophthalmology pipeline.