Skye Bioscience Stock Price, News & Analysis

Skye Bioscience (OTCQB: SKYE) announced the completion of SBI-100 Ophthalmic Emulsion production for its Phase 1 clinical trial, which focuses on treating glaucoma. The final product is expected to be clinically available in October, pending quality testing results. Clinical site initiation will occur in mid-October, followed by patient dosing starting in November. SBI-100 OE aims to effectively lower intraocular pressure (IOP) using a novel synthetic cannabinoid formulation, potentially offering a new treatment class for glaucoma, a leading cause of irreversible blindness.

Skye Bioscience, Inc. (OTCQB: SKYE) announced the filing of its definitive proxy statement ahead of a special meeting on September 30, 2022. This meeting will address a proposed business combination with Emerald Health Therapeutics, Inc. Stockholders as of August 29, 2022, will receive voting materials via mail or email. CEO Punit Dhillon expressed gratitude for Emerald's support and emphasized the importance of stockholder voting to secure valuable resources for their business plan. The definitive proxy statement is available for viewing online.

Skye Bioscience (OTCQB: SKYE) announces that 87.07% of Emerald Health Therapeutics shareholders approved the proposed merger plan. The next step involves Skye seeking shareholder approval in an upcoming meeting. Regulatory approval for Skye's Phase 1 clinical study has been granted, with enrollment expected to complete by early 2023. The company plans to submit its Investigational New Drug application to the FDA by year-end 2022 for a Phase II study on SBI-100 targeting glaucoma, a condition affecting over 70 million people worldwide.

Skye Bioscience has selected NextPharma as its contract manufacturing organization for the Phase 2 clinical trial of its proprietary synthetic cannabinoid, SBI-100 Ophthalmic Emulsion, aimed at treating glaucoma. Following a successful pre-IND meeting with the FDA, Skye plans to file for a US IND by Q4 2022 and commence the Phase 2 study in H1 2023, with results expected by year-end 2023. The development of SBI-100 OE may provide a new class of medicine for glaucoma, enhancing therapeutic efficacy in lowering intraocular pressure.

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.