Welcome to our dedicated page for Skye Bioscience news (Ticker: SKYE), a resource for investors and traders seeking the latest updates and insights on Skye Bioscience stock.
Skye Bioscience, Inc. (Nasdaq: SKYE) is a cutting-edge, clinical-stage biopharmaceutical company based in San Diego, California. Focused on the development of innovative therapies, Skye leverages the endocannabinoid system to address diseases characterized by metabolic, inflammatory, and fibrotic processes.
The company's prominent clinical candidates include nimacimab and SBI-100 Ophthalmic Emulsion (SBI-100 OE). Nimacimab is a groundbreaking humanized monoclonal antibody that functions as a negative allosteric modulator of the cannabinoid 1 receptor (CB1). By targeting CB1 in peripheral tissues, nimacimab aims to treat diseases like obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH) without the central nervous system (CNS) side effects that plagued earlier CB1 inhibitors. Currently, Skye is gearing up for a Phase 2 clinical trial of nimacimab in patients with obesity and chronic kidney disease, expected to begin in mid-2024.
Meanwhile, SBI-100 OE is under investigation for its potential to lower intraocular pressure in patients suffering from glaucoma and ocular hypertension. Although the Phase 2a trial did not meet its primary endpoint for reducing intraocular pressure, the drug demonstrated a favorable safety profile, paving the way for further research and development.
Recent news highlights Skye's strategic focus and financial stability. As of June 2024, the company announced the discontinuation of clinical development for SBI-100 OE, allowing Skye to redirect resources fully towards its metabolic program, extending its operational runway into 2027. Backed by leading life science venture investors, including Perceptive Advisors and 5AM Ventures, Skye successfully raised $90.25 million through two private placements in the first quarter of 2024, ensuring robust financial resources to support its ambitious clinical development plans.
For more information, please visit the company's website at www.skyebioscience.com.
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.
Skye Bioscience (OTCQB: SKYE), a biopharmaceutical firm, announced its participation in the virtual H.C. Wainwright BIOCONNECT Conference from January 10-13, 2022. CEO Punit Dhillon will present an on-demand overview on January 10 at 7 AM ET, accessible via a webcast. Virtual one-on-one meetings will also be available for institutional investors. Skye's lead program is focused on developing cannabinoid-derived treatments for glaucoma.
Skye Bioscience has appointed Keith W. Ward, PhD to its board of directors and promoted Tu Diep, MSc to Chief Development Officer. This leadership change aims to enhance the company's direction in developing cannabinoid-based therapies targeting significant unmet medical needs, particularly in treating glaucoma. Dr. Ward brings over 25 years of industry experience, while Mr. Diep, previously Senior VP of Development, has over 15 years in drug development. The company emphasizes its focus on advancing therapies in a challenging therapeutic landscape.
Skye Bioscience (OTCQB: SKYE) announced that researchers from the University of Mississippi presented two studies at the AAPS PharmSci 360 meeting. The studies focused on the effects of THCVHS, a synthetic cannabinoid, on lowering intraocular pressure (IOP) in glaucoma treatment. Findings revealed that THC-VHS nanoemulsion formulations showed better IOP reduction compared to standard treatments. The company is advancing its clinical strategy, with human trials expected to start in Q2-22, focusing on safety and efficacy for glaucoma treatment.
Skye Bioscience (OTCQB: SKYE) has signed an exclusive research agreement with Emerald Health Biotechnology Espana SLU to develop cannabinoid-derived molecules for therapeutic purposes. This agreement, dubbed the Cannabinoid Pharmaceutical Innovation Program (CPIP), aims to enhance signaling pathways in the endocannabinoid system. Skye will finance the projects and retain rights to all resulting data and intellectual property. The initiative aims to create a portfolio of proprietary products that focus on treating diseases with significant unmet needs, particularly in ophthalmology.
Skye Bioscience (OTCQB: SKYE) has appointed Rhea Williams, MPH, as Head of Regulatory Affairs & Quality Assurance and Varun Khurana, PhD, as Senior Director of Research & Development. Williams has over 25 years of experience in drug development across multiple disease areas. Khurana brings over seven years of expertise in drug formulation and development, having previously worked at GlaxoSmithKline. The company aims to initiate its first-in-human trial for glaucoma, signaling an important phase in its growth strategy.
Skye Bioscience, Inc. (OTCQB: SKYE) has appointed Kaitlyn Arsenault, CPA, as its new Chief Financial Officer. With over 14 years of experience in financial reporting and operations, Arsenault previously served as an independent consultant for emerging companies, including Skye. CEO Punit Dhillon highlighted her expertise in financial controls and reporting as crucial for the company's clinical development and growth objectives. Arsenault expressed commitment to advancing Skye's financial priorities and stakeholder commitments.
Skye Bioscience (SKYE) has successfully closed a registered direct offering, selling 77,777,779 shares of common stock and warrants at an effective price of $0.09 per share, grossing approximately $7 million. The proceeds will support general corporate purposes, including working capital and potential acquisitions. The warrants are exercisable immediately and expire in five years. CEO Punit Dhillon emphasizes that this financing positions the company to advance its drug candidate for glaucoma and enhance its pharmaceutical cannabinoid R&D initiatives, aiming to build shareholder value.
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