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 (SKYE) is a clinical-stage biopharmaceutical innovator developing targeted therapies through cannabinoid receptor modulation. This page serves as the definitive source for verified company announcements, research milestones, and financial updates.
Investors and researchers will find timely updates on clinical trials, regulatory developments, and strategic partnerships. Our curated collection includes earnings reports, pipeline progress for nimacimab (peripheral CB1 inhibitor), and scientific presentations - all organized for efficient due diligence.
Key focus areas include metabolic disorder therapeutics, antibody-based drug development, and clinical safety data. Content is rigorously verified to ensure compliance with financial disclosure standards while maintaining accessibility for both specialist and general audiences.
Bookmark this page for structured access to SKYE's evolving position in biopharmaceutical innovation, with particular emphasis on obesity treatment research and peripheral endocannabinoid system modulation.
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.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on metabolic health, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Board of Directors granted a non-qualified stock option award to purchase 40,000 shares of common stock to a new non-executive employee under its 2024 Inducement Equity Incentive Plan.
The stock options have an exercise price of $5.28 per share, equal to the closing price of Skye's common stock on August 22, 2024. The shares will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 monthly installments, subject to continued employment. This grant is part of Skye's strategy to attract new talent and align employee interests with company growth.
Skye Bioscience (Nasdaq: SKYE) has launched a Phase 2 clinical trial, CBeyond™, to evaluate its peripheral CB1 inhibitor, nimacimab, for weight loss in patients with obesity. The study will assess nimacimab's efficacy as a monotherapy and in combination with a GLP-1 receptor agonist (Wegovy®). Key aspects of the trial include:
- 120 patients across four treatment groups
- 26-week treatment period with 13-week follow-up
- Primary endpoint: weight loss comparison between nimacimab and placebo
- Secondary endpoints: safety, tolerability, and body composition changes
- Exploratory endpoints: metabolic parameters and sleep quality assessment
Skye aims to report interim data in Q2 2025 and final data in Q4 2025. The company believes nimacimab's unique biologic approach may offer improved safety and efficacy compared to small molecule CB1 inhibitors.
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