SAN DIEGO, June 23, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced the debut of its “Anatomy of Progress” nimacimab development update video series and availability of presentations related to the development of its anti-obesity drug, nimacimab, presented in multiple forums at the American Diabetes Association’s (ADA) 85th Scientific ...

SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that it was selected to present new nimacimab data in its expanded preclinical model at the upcoming American Diabetes Association’s (ADA) 85th Scientific Sessions. Skye will present in multiple forums at the ADA conference, which is being held June 20th – 23rd, 2025, ...

Industry Overview - The obesity market is rapidly expanding, driven by the success of GLP-1 therapies Wegovy and Zepbound, and is projected to reach $100 billion by 2030 [1] - There is a growing interest in cannabinoid (CBD)-based therapies as companies seek to innovate beyond GLP-1s for weight management [2] - The cannabis industry is also experiencing significant growth, expected to surpass $200 billion by 2032, although direct investments in cannabis companies have been challenging due to regulatory issues [3] Company Analysis Novo Nordisk - Novo Nordisk is a leader in obesity treatments with its semaglutide products, Wegovy and Ozempic, but faces increasing competition from Eli Lilly [5] - The company entered the CBD space by acquiring Inversago Pharmaceuticals in 2023, adding monlunabant, an investigational oral cannabinoid drug for metabolic diseases [6] - A phase IIa study on monlunabant showed statistically significant weight loss compared to placebo, but higher doses had diminishing returns; a phase IIb study is planned to find an optimal dose [7] - EPS estimates for 2025 have increased from $3.81 to $3.84, while 2026 estimates have slightly decreased from $4.66 to $4.64; the stock has declined about 21% year to date due to competition and regulatory challenges [8] Corbus Pharmaceuticals - Corbus' lead CBD candidate, CRB-913, targets the same CB1 receptor as monlunabant and is currently in phase I studies, with results expected in Q3 2025 [9] - Preclinical data suggest CRB-913 may have advantages over previous therapies, with a significantly lower brain-to-plasma ratio, indicating reduced neuropsychiatric side effects [10] - Corbus is also developing two oncology drugs, CRB-701 and CRB-601, with CRB-701 in phase I/II studies [11] - Loss per share estimates for 2025 have increased from $5.47 to $6.34, and for 2026 from $5.30 to $5.39; the stock has declined 36% year to date, reflecting regulatory volatility [12][13] Skye Bioscience - Skye Bioscience is developing nimacimab, a monoclonal antibody targeting the CB1 pathway, currently in a phase II study evaluating its efficacy as a monotherapy and in combination with Wegovy [14] - Nimacimab is designed to minimize brain penetration while maintaining metabolic effects, with early studies showing no adverse psychiatric events [15] - Loss per share estimates for 2025 have widened from $1.27 to $1.31, and for 2026 from $1.48 to $1.52; the stock has lost 27% year to date due to financial concerns and lack of commercial revenues [16]

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that it will participate in the following upcoming healthcare conferences: Investment Conferences Jefferies Global Healthcare Conference (New York)   Presentation Thursday, June 5, 9:20 AM ET + 1x1 meetings Sachs European BioPharma Obesity Innovation Forum   Next Gen Th ...

Core Insights - Skye Bioscience is collaborating with Arecor Therapeutics to develop a higher concentration formulation of nimacimab, a CB1 inhibitor, utilizing Arecor's Arestat™ technology [1][2][3] - Nimacimab is currently being evaluated in a Phase 2a clinical trial for obesity, with initial data expected in late Q3 or early Q4 2025 [2][5] - The partnership allows Skye to fund Arecor's development activities and potentially license the new formulation and associated intellectual property [2][3] Company Overview - Skye Bioscience focuses on developing next-generation therapeutic pathways for metabolic health, particularly through G-protein coupled receptors [5] - The company is conducting a Phase 2a clinical trial for nimacimab, which is a negative allosteric modulating antibody that inhibits CB1 [5] - Arecor Therapeutics aims to enhance existing therapeutic products and has a proprietary technology platform, Arestat™, supported by a strong patent portfolio [4] Product Development - Nimacimab has a pharmacokinetic profile with a half-life of 18–21 days, which is significantly longer than GLP-1-based therapies, and is being evaluated for once-weekly dosing [3] - The collaboration aims to address issues related to tolerability and adherence seen in approved weight loss drugs, as well as concerns about neuropsychiatric toxicities associated with small molecule CB1 inhibitors [3]

Nimacimab in combination with tirzepatide improves weight loss effect over tirzepatide alone, and shows comparable weight loss to monlunabant and tirzepatide alone in preclinical diet-induced obesity modelIn vitro data reported from new preclinical study highlights superior potency of peripherally restricted CB1 inhibitor, nimacimab, versus monlunabant when tested under pathological levels of CB1 agonistsExpanded preclinical study data to be presented at ADA in June 2025Top-line data readout from CBeyond™ P ...

SAN DIEGO, May 07, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) ("Skye"), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, will host a conference call on Thursday, May 8th at 1:30 p.m. PT/4:30 p.m. ET to discuss its 2025 first quarter financial results. An earnings press release will be issued after the market close on May 8th. LifeSci Advisors, Mike Moyer mmoyer@lifesciadvisors.com (617) 308-4306 The live ...

Available webcasts will be accessible on Skye's website. About Skye Bioscience Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next- generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) i ...

Core Viewpoint - Skye Bioscience, Inc. announced promising preclinical data for its CB1 antibody, nimacimab, indicating significant weight loss in a murine diet-induced obesity model, suggesting potential as a treatment for obesity and metabolic disorders [1][2][5] Group 1: Preclinical Data and Efficacy - Nimacimab demonstrated effective weight loss in a diet-induced obesity model after 25 days of treatment, showing a 23.5% weight loss when used alone, comparable to monlunabant and tirzepatide [5] - When combined with tirzepatide, nimacimab achieved greater than 30% weight loss, indicating an additive effect [5] - The study highlighted that nimacimab's weight loss was associated with beneficial changes in key hormones, glycemic control, and inflammatory markers [1][5] Group 2: Mechanism of Action - Nimacimab employs a non-competitive allosteric binding mechanism to the CB1 receptor, which may provide advantages over small molecules like monlunabant that compete for the receptor's active site [3][7] - In vitro data showed that nimacimab's potency remained stable even at higher concentrations of CB1 agonists, while monlunabant's potency significantly decreased under similar conditions [6][9] - The differentiated mechanism of nimacimab aims to achieve weight loss benefits without the neuropsychiatric side effects associated with current small molecule CB1 inhibitors [7][10] Group 3: Future Developments - Skye anticipates initial data from its Phase 2a study in obesity to be available in late Q3 or early Q4 2025, which will further assess nimacimab's efficacy [2][5] - The company is conducting a Phase 2 clinical trial to evaluate nimacimab's effects both as a monotherapy and in combination with GLP-1 receptor agonists [10]

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [2] - The company aims to create first-in-class therapeutics by leveraging biologic targets with substantial human proof of mechanism [2] Clinical Development - Skye is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, specifically targeting obesity [2] - The trial is also assessing the combination of nimacimab with a GLP-1R agonist, Wegovy® [2] Upcoming Events - The executive team of Skye will be available for one-on-one meetings at the Piper Sandler Spring Biopharma Symposium on April 17th in Boston, MA [1]