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 (Nasdaq: SKYE), a clinical-stage biopharmaceutical company specializing in obesity and metabolic health disorders treatments, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company will deliver a corporate overview on Thursday, January 16, 2025, from 10:30 AM to 11:10 AM. Interested parties can access both live and archived versions of the presentation through Skye's website.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company specializing in metabolic health therapeutics, has announced its participation in three major healthcare investment conferences in December. The company will attend the Evercore HealthCONx Conference in Miami for a fireside chat on December 3 at 2:10 pm ET, the Citi Global Healthcare Conference in Miami on December 5 for one-on-one meetings, and the Piper Sandler Annual Healthcare Conference in New York City for a fireside chat on December 5 at 11:30 am ET. Webcasts of available sessions will be accessible through Skye's website.
Skye Bioscience has reached over 50% enrollment in its CBeyond™ Phase 2 clinical trial evaluating nimacimab, a CB1 inhibitor for obesity treatment. The study aims to enroll 120 patients across four treatment groups, with interim data expected in Q2 2025. The trial's primary endpoint will measure weight loss compared to placebo, with an exploratory endpoint assessing nimacimab combined with Wegovy®. Nimacimab is highlighted as the most peripherally restricted CB1 inhibitor, showing promising preclinical results with minimal brain accumulation and no neuropsychiatric adverse events in Phase 1 studies.
Skye Bioscience reported Q3 2024 financial results and highlighted the launch of its Phase 2 obesity clinical trial for nimacimab, a CB1-inhibiting monoclonal antibody. The company reported cash position of $76.5 million, including restricted cash of $9.1 million. R&D expenses increased to $4.9 million from $1.3 million year-over-year, while G&A expenses rose to $4.6 million from $2.2 million. Net loss decreased to $3.9 million compared to $24.9 million in Q3 2023. The Phase 2 trial started enrolling patients in August 2024, with interim data targeted for Q2 2025 and topline data for Q4 2025.
Skye Bioscience (Nasdaq: SKYE) announced preliminary data from a diet-induced obesity (DIO) model study of their CB1-inhibiting antibody, nimacimab. The study demonstrated significant dose-dependent weight loss of up to 16% compared to vehicle control. The experiment used transgenic mice expressing human CB1 receptor, treated with various doses of nimacimab over 35 days. Key findings included dose-dependent weight loss (4.5%, 11.4%, and 16.0%), significant fat mass reduction while preserving lean mass, and improved glucose tolerance. The data suggests peripheral CB1 inhibition drives weight loss without central inhibition's neuropsychiatric risks.
Skye Bioscience (Nasdaq: SKYE) has scheduled the release of its third quarter 2024 financial results for Thursday, November 7, 2024, after market close. The clinical-stage biopharmaceutical company, which focuses on metabolic health therapeutics, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. Investors can access the live webcast, earnings release, financial tables, and presentation through Skye's Investor Relations website, where a replay and transcript will be available afterward.
Skye Bioscience (Nasdaq: SKYE) has appointed independent director Paul Grayson as Chairman of the Board, effective October 25, 2024. Grayson, who serves on Skye's Audit, Compensation and Nominating and Corporate Governance Committees, replaces former Chairman Punit Dhillon, who remains CEO and board member. The move aims to increase board independence and enhance governance structures. Grayson currently serves as CEO of Radionetics Oncology and has previous experience as CEO of Tentarix Biotherapeutics, with founding roles at Fate Therapeutics, BirdRock Bio, Senomyx, and Aurora Biosciences.
Skye Bioscience (Nasdaq: SKYE) has commented on Novo Nordisk's Phase 2a top-line data for monlunabant, a small-molecule oral CB1 inverse agonist. The study met its primary endpoint, showing at least 6% placebo-adjusted weight loss at 16 weeks. However, dose-dependent neuropsychiatric side effects were observed.
Skye highlights the advantages of their large-molecule CB1 inhibitor, nimacimab, over small-molecule approaches. Nimacimab has shown minimal brain accumulation in preclinical studies and no neuropsychiatric adverse events in Phase 1 trials. Skye believes nimacimab offers a potential safety advantage due to its peripheral restriction.
Skye's Phase 2 trial of nimacimab in obesity, launched in August 2024, is expected to report interim weight loss data in Q2 2025 and top-line data in Q4 2025. The company remains confident in nimacimab's development plan and its potential for a wider therapeutic index compared to small-molecule CB1 inhibitors.
Skye Bioscience (Nasdaq: SKYE) has appointed Dr. Puneet S. Arora as Chief Medical Officer. Dr. Arora, a board-certified physician in endocrinology, diabetes, and metabolism, brings over 15 years of experience in clinical trial design and execution. His appointment comes as Skye initiates its Phase 2 CBeyond™ obesity clinical trial for nimacimab, a differentiated CB1 inhibitor.
Dr. Arora's expertise in metabolic diseases and his track record in drug development are expected to be valuable assets for Skye. The company aims to leverage his knowledge to advance treatments that can significantly improve health outcomes, particularly in the field of obesity therapeutics.
In connection with Dr. Arora's appointment, Skye granted him a stock option to purchase 225,000 shares of common stock under the company's 2024 Inducement Equity Incentive Plan.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on metabolic health, has announced its participation in three upcoming healthcare investment conferences in September 2024:
- Morgan Stanley conference on September 6 (1x1 meetings)
- Cantor Global Healthcare Conference on September 19 (presentation and 1x1 meetings)
- Bank of America World Medical Innovation Forum on September 24 (panel and 1x1 meetings)
These events provide Skye with opportunities to present its research and engage with investors. Webcasts of available presentations will be accessible on Skye's website, offering wider access to the company's updates and progress in the field of metabolic health therapeutics.
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