Skye Bioscience Shares Nimacimab "Anatomy of Progress" Video Series and Highlights Preclinical CB1 Antibody Data Presented at the American Diabetes Association's 85th Scientific Sessions
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 Sessions held June 20-23, 2025, in Chicago, Illinois. The presentations are accessible at the following link.
Skye Video Series: "Anatomy of Progress"
In this four-part video series highlighted below, Skye discusses unmet needs in the obesity therapeutic space, advantages and benefits of its peripheral CB1-receptor-targeting antibody, which is designed to support healthy weight loss, and development progress of this novel CB1-inhibiting molecule.
Skye's Chief Executive Officer, Punit Dhillon, commented on the important mechanistic advantages of nimacimab versus other CB1 inhibitors highlighted in this video update series: "Obesity isn't just a public health crisis, it's a biologically defended state, one that resists traditional treatments requiring smarter and safer interventions.
"At Skye, we're developing nimacimab, a CB1 antibody that targets receptors in the periphery, while remaining greater than 99% excluded from the brain. Unlike the small molecule CB1 inhibitors currently in development, nimacimab's differentiating peripheral restriction has the potential to demonstrate the same weight loss and metabolic benefits previously seen in clinical trials by first-generation CB1 inhibitors, without the significant neuropsychiatric liabilities that continue to plague its small molecule counterparts. So nimacimab is not just another anti-obesity drug, it represents a new frontier in how we think about fat metabolism, safety and long-term care."
The Anatomy of Progress video series is comprised of:
- Overview – Highlights Skye's positioning and progress in the obesity landscape, noting the differentiation of its allosteric modulating antibody.
- Chapter 1: Nimacimab – A Differentiated CB1 Inhibitor for Obesity – A review of Skye's highly peripherally-restricted CB1 inhibitor and its potential advantages relative to the incretin class of anti-obesity drugs and small-molecule CB1 inhibitors, with recent preclinical data.
- Chapter 2: Nimacimab in the Clinic – Reviews Skye's current clinical activity and near-term Phase 2a clinical data readouts.
- Chapter 3: Market Opportunity for Nimacimab – Discusses input from obesity physicians that frames the distinct opportunity for a non-GLP1 obesity therapeutic with nimacimab's target product profile.
Evercore ISI Panel
Members of Skye's management team; Punit Dhillon, Puneet Arora, MD, FACE, and Chris Twitty, PhD participated in a non-incretin therapeutics panel at Evercore's concurrent investor-focused obesity event. Hosted by Evercore's equity research analysts, Liisa Bayko and Umer Raffat, the panel featured notable obesity physicians Helena Rodbard, MD, FACP, MACE, and Sean Wharton, MD, PharmD. The panel reviewed the clinical and preclinical experience with the CB1 pathway and nimacimab's peripheral CB1 blockade as well as the broader non-incretin toolkit supporting obesity care beyond the limits of the GLP-1 era.
ADA Innovation Hub
Title: Mechanistic Insights into Weight Loss and Metabolic Regulation of Obese Mice Treated with Nimacimab, a Peripherally-restricted CB1 Inhibitor
In this ADA symposium, Chris Twitty, PhD, CSO, reviewed the distinguishing characteristics of nimacimab, reiterated meaningful weight loss data from a pre-clinical diet-induced obesity model that underscores nimacimab's potential as a standalone obesity treatment and as a combination therapy, and introduced new biomarker data showing important reductions in obesity-induced inflammation and liver steatosis.
Poster
Title: Nimacimab, a Peripherally Restricted CB1 Inhibitor, Promotes Metabolic Homeostasis in a Diet-Induced Obesity (DIO) Mouse Model as Demonstrated by Weight Loss, Restored Hormonal Regulation, and Reduced Inflammatory Biomarkers
This poster highlighted nimacimab's ability to achieve weight reduction and deliver comprehensive metabolic improvements including enhanced body composition, restoration of metabolic homeostasis, and improved hormonal profiles.
These studies and presentations highlight that peripheral inhibition of CB1 using a monoclonal antibody that does not cross the blood-brain barrier is effective, and has differentiating yet complementary mechanisms that make it an ideal combination with incretin-based drugs. These presentations are accessible at the following link.
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) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.
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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. 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. These forward-looking statements include, but are not limited to: statements concerning Skye's future plans and prospects, any expectations regarding the safety, efficacy, tolerability or combinability of nimacimab, including based on preclinical diet induced obesity (DIO) studies and clinical studies, the timing of the receipt of final data from our clinical studies, the potential market opportunities, the timing and clinical strategy for nimacimab, the planned timing of Skye's anticipated milestones for nimacimab and the company's cash runway. 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. 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.
