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) generates news primarily through its clinical and corporate progress in metabolic health, with a focus on obesity and overweight. The company regularly issues press releases on its Phase 2a CBeyond™ trial of nimacimab, a peripherally restricted CB1-inhibiting monoclonal antibody, and on related clinical, preclinical, and corporate milestones.
Readers of the SKYE news page can expect updates on topline and extension data from the CBeyond Phase 2a study, including weight loss outcomes, body composition findings, and analyses of rebound weight gain after treatment discontinuation. Skye’s releases have highlighted the performance of nimacimab as a monotherapy and in combination with semaglutide, reporting clinically meaningful additional weight loss, changes in waist circumference, and observations about safety, gastrointestinal tolerability, and neuropsychiatric events.
The company also publishes news on preclinical diet-induced obesity models, where nimacimab has been evaluated alone and with incretin-based therapies such as tirzepatide. These announcements describe weight loss effects, post-treatment weight maintenance, and modulation of metabolic and inflammatory pathways in animal studies. In addition, Skye reports on Phase 1b data in metabolic-associated steatotic liver disease, conference presentations at scientific and medical meetings, and participation in healthcare and investor conferences.
Corporate and regulatory news items include financial results, business updates, and collaboration agreements, such as Skye’s non-exclusive global collaboration and license agreement with Halozyme Therapeutics to use ENHANZE drug delivery technology for higher-dose subcutaneous administration of nimacimab. For investors and observers tracking developments in obesity therapeutics and CB1 inhibition, the SKYE news feed offers a centralized view of Skye’s reported clinical data, preclinical research, partnering activity, and financial disclosures over time.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on obesity and metabolic health disorders, has announced its participation in two upcoming investor conferences in February 2025.
The company will participate in the BIO CEO & Investor Conference in New York on February 10, where they will join a panel discussion on 'Obesity: Next Medicines with Impact' at 11:00 AM ET. Additionally, Skye will present a corporate overview at the virtual Oppenheimer 35th Healthcare Life Sciences Conference on February 12 at 12:00 PM ET. A webcast of the presentation will be available on Skye's website.
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company, has provided an outlook for 2025, highlighting key milestones and achievements. The company is focused on the development of nimacimab, a first-in-class CB1 inhibitor antibody aimed at treating obesity. Key milestones in 2025 include the completion of enrollment in the CBeyond™ Phase 2 obesity trial and the release of interim data in Q2, followed by topline weight loss data in Q4.
In 2024, Skye achieved several milestones, including the launch of the CBeyond™ Phase 2 trial, the first to assess a GLP-1/CB1 inhibitor combination, and the enrollment of 50% of patients by November 2024. Preclinical data showed significant dose-dependent weight loss and fat mass reduction with lean mass preservation. The company also raised $90M in equity financings and expanded its leadership team.
Skye plans to participate in major scientific conferences in 2025, including the European Congress on Obesity and the American Diabetes Association's 85th Scientific Sessions. They will also present at the 43rd annual J.P. Morgan Healthcare Conference on January 16, 2025.
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.
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