Skye Bioscience Establishes Metabolic Clinical and Scientific Advisory Board to Support Development of Nimacimab

SAN DIEGO, July 11, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel classes of therapeutic drugs that modulate the endocannabinoid system, today announced the formation of its clinical advisory board (CAB), gathering renowned academics and world-class metabolic disease experts, particularly in the field of obesity. The CAB will work closely with management to provide strategic and scientific counsel to support the development of the Company’s lead candidate, Nimacimab, a cannabinoid 1 (CB1) receptor inhibitor, which is expected to enter a Phase 2 trial in individuals with obesity in Q3 2024.

“We are honored to unite these world-class obesity experts as we continue to advance the clinical development of Nimacimab for the treatment of obesity,” said Punit Dhillon, Chief Executive Officer and Chairman of Skye. “Their extensive scientific and clinical expertise will be instrumental in providing strategic oversight to support Skye as we expand our operations. We look forward to leveraging their guidance as we prepare to progress Nimacimab into a Phase 2 trial this quarter.”

Members of the Clinical and Scientific Advisory Board include:

Lee Kaplan, MD, Ph.D., is a Professor of Medicine and Chief of the Division of Obesity Medicine at the Geisel School of Medicine at Dartmouth, and Director of the Dartmouth Weight and Wellness Center. He is the Chair of the U.S. Obesity Medicine Fellowship Council, Director of the Boston Course in Obesity Medicine, and Chairman Emeritus of the Campaign to End Obesity. He is a member of external advisory and steering committees for numerous academic, clinical and corporate obesity research and clinical programs. Dr. Kaplan has authored over 250 papers; his group pioneered the development of rodent models that contributed to our understanding of clinical, biological and genetic predictors of patient response to various obesity therapies.

Louis Aronne, MD, a leading authority on the treatment of obesity, is the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medical College. He directs the Center for Weight Management and Metabolic Clinical Research and is an adjunct appointment at Columbia University College of Physicians and Surgeons. Dr. Aronne is Founder and CEO of BMIQ, a weight control program. He has authored over 60 papers and book chapters on obesity and edited the National Institutes of Health Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.

Rekha Kumar, MD, M.S., is an Associate Professor of Clinical Medicine and attending Endocrinologist at the Weill Cornell Medical College, specializing in the diagnosis and treatment of various endocrine and metabolic disorders, including obesity/weight management, type 2 diabetes, polycystic ovarian syndrome (PCOS), thyroid disorders, and metabolic bone disease. She is also Chief Medical Officer of Found Health.

Marcus DaSilva Goncalves, MD, Ph.D., is an Associate Professor of Medicine and Director of Systemic Metabolism Research at NYU Langone Health. He is a physician-scientist with expertise in the systemic pathways that regulate body weight, muscle mass, and metabolism. His lab uses preclinical models and human samples to develop novel treatments for diseases like obesity, cachexia, and cancer. As a practicing endocrinologist, Dr. Goncalves regularly cares for patients with obesity, diabetes, and cancer experiencing endocrine complications, including cachexia and other metabolic diseases.

Beverly Tchang, MD, is a triple board-certified physician focusing on obesity medicine and an Assistant Professor of Clinical Medicine at Weill Cornell. Since 2018, she has treated patients and trained professionals in endocrinology and obesity. Dr. Tchang's nationally recognized expertise has led her to extend her knowledge and experience as an advisor to companies, entrepreneurs, and investors who want to learn about modern weight management.

Eduardo Muñoz, MD, Ph.D., is a Professor of Immunology in the Department of Cell Biology, Physiology, and Immunology of the University of Córdoba, Spain. He is also the director of the inflammation and cancer research group at the Institute Maimonides for Biomedical Research of Córdoba. He is an expert in the mechanisms of action of cannabinoids and endocannabinoids as well as the development of cannabinoid-based new chemical entities. Dr. Muñoz has authored nearly 200 articles, patents, and book chapters and belongs to the editorial board of several scientific journals.

Giovanni Appendino, Ph.D., is a Professor of Organic Chemistry in the Department of Pharmaceutical Sciences, University of Eastern Piedmont in Novara, Italy. His research of natural products lead to the discovery and isolation of over 200 novel compounds, including novel phytocannabinoids and chemistry for cannabinoid-derived molecules. Dr. Appendino has authored over 400 peer-reviewed articles, 15 book chapters, and 32 patents on natural products chemistry and bioactivity. He is Editor-in-Chief of the Journal Fitoterapia and editorial board member of multiple journals.

About Nimacimab

Nimacimab is a first-in-class humanized monoclonal antibody that acts as a negative allosteric modulator to inhibit CB1 signaling in the periphery. Inhibition of CB1 has shown anti-fibrotic, anti-inflammatory, and metabolic mechanisms of action with potential to address a broad range of diseases with notable unmet medical needs such as obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).

About Skye Bioscience

Skye is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with metabolic, inflammatory, and fibrotic processes. Backed by specialist life science investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Skye plans to start a Phase 2 clinical trial in obesity in Q3 2024 for Nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1, comparing monotherapy and combination arms of Nimacimab and a GLP-1R agonist. Please visit: https://www.skyebioscience.com.

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FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our product development, business strategy and the timing of clinical trials. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.