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

Rhea-AI Summary

Skye Bioscience (NASDAQ: SKYE) has unveiled its 'Anatomy of Progress' video series and presented preclinical data for nimacimab, its novel anti-obesity drug, at the American Diabetes Association's 85th Scientific Sessions. Nimacimab is a peripherally-restricted CB1 receptor antibody that remains over 99% excluded from the brain, potentially offering the same weight loss benefits as first-generation CB1 inhibitors without their neuropsychiatric side effects. The four-part video series details the drug's development, market positioning, and clinical progress. Preclinical data demonstrated significant weight reduction, improved metabolic homeostasis, and reduced obesity-induced inflammation in diet-induced obesity mouse models. The company also participated in an Evercore ISI panel discussing non-incretin obesity treatments, highlighting nimacimab's potential as both a standalone therapy and in combination with incretin-based drugs.

Positive

• Nimacimab demonstrates peripheral restriction with >99% brain exclusion, potentially avoiding neuropsychiatric side effects
• Preclinical data shows promising weight loss results and metabolic improvements in mouse models
• Drug shows potential as both standalone treatment and combination therapy with incretin-based drugs
• Demonstrated ability to reduce obesity-induced inflammation and liver steatosis in preclinical studies

Negative

• Drug is still in early clinical stages with pending Phase 2a data readouts
• Will need to compete with established incretin-based therapies in the obesity market

Insights

Biotech Analyst

Skye's peripheral CB1 receptor antibody shows promising preclinical data for obesity treatment with potentially better safety than competitors.

Skye Bioscience has unveiled promising preclinical data for nimacimab, its peripheral CB1 receptor-targeting antibody for obesity treatment. The company presented this data at the American Diabetes Association's 85th Scientific Sessions alongside launching an educational video series called "Anatomy of Progress."

The key scientific differentiation for nimacimab appears to be its peripheral restriction, with the antibody remaining >99% excluded from the brain. This approach potentially overcomes the neuropsychiatric side effects that plagued earlier generations of CB1 inhibitors while maintaining efficacy. Preclinical data from diet-induced obesity mouse models demonstrated meaningful weight loss and improvements in metabolic parameters.

The preclinical results specifically showed nimacimab improved body composition, restored metabolic homeostasis, improved hormonal profiles, and reduced obesity-induced inflammation and liver steatosis. These comprehensive metabolic improvements suggest nimacimab could address multiple aspects of obesity beyond just weight loss.

Strategically, Skye is positioning nimacimab as both a standalone therapy and as a potential combination therapy with incretin-based drugs like GLP-1 agonists. The company emphasizes that nimacimab's mechanism is complementary to incretin approaches, potentially creating opportunities in the expanding obesity treatment market.

With Phase 2a clinical data readouts approaching, investors should monitor these upcoming results closely, as they will provide crucial insights into whether nimacimab's promising preclinical profile translates to human efficacy and safety. The participation of Skye's management in Evercore's obesity-focused event alongside prominent obesity physicians indicates growing industry interest in non-incretin approaches to obesity treatment.

Skye also participated in Evercore ISI obesity-focused event panel discussing CB1 and other non-incretin pathways

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) 85^th 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.

CONTACTS

Investor Relations
ir@skyebioscience.com
(858) 410-0266

LifeSci Advisors, Mike Moyer
mmoyer@lifesciadvisors.com
(617) 308-4306

Media Inquiries 
LifeSci Communications, Michael Fitzhugh 
mfitzhugh@lifescicomms.com
(628) 234-3889

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.

FAQ

What is nimacimab and how does it work for obesity treatment?

Nimacimab is a peripherally-restricted CB1 receptor antibody that targets receptors outside the brain to promote weight loss, while remaining >99% excluded from the brain to avoid neuropsychiatric side effects.

What are the key advantages of SKYE's nimacimab over other obesity treatments?

Nimacimab's main advantage is its peripheral restriction that avoids brain-related side effects while potentially offering similar weight loss benefits as first-generation CB1 inhibitors, and it can potentially be used alone or combined with incretin-based drugs.

What results did Skye Bioscience's preclinical trials show for nimacimab?

Preclinical trials in diet-induced obesity mouse models showed significant weight reduction, improved metabolic homeostasis, reduced inflammation, and improved hormonal profiles.

When will Skye Bioscience (SKYE) release Phase 2a clinical data for nimacimab?

The press release indicates Phase 2a clinical data readouts are upcoming but does not specify exact timing.

How does nimacimab differ from incretin-based obesity drugs?

Nimacimab works through CB1 receptor inhibition rather than the incretin pathway, offering a different mechanism of action that could complement existing incretin-based therapies.