Skye Bioscience to Host Virtual KOL Event and Provide Perspectives on Upcoming CBeyond™ Phase 2a Topline Clinical Data Readout

Rhea-AI Summary

Skye Bioscience (NASDAQ:SKYE) has announced a virtual KOL event scheduled for September 4, 2025, at 8:00 AM ET. The event, titled "Expert Panel on Peripheral CB1 Inhibition as a Mechanism for Weight Loss," will focus on the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, their first-in-class peripheral CB1 antibody for obesity treatment.

The event will feature distinguished obesity experts including Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves. Key discussion topics will include success criteria for the Phase 2a study, mechanism of peripheral CB1 inhibition, new preclinical data, and safety considerations including gastrointestinal and neuropsychiatric outcomes. While no clinical results will be previewed, the event aims to provide context for interpreting the upcoming data readout and nimacimab's potential role in obesity treatment.

Insights

Biotechnology Investment Analyst

Skye's upcoming KOL event signals confidence ahead of critical Phase 2a obesity drug data that could validate their novel CB1 pathway.

Skye Bioscience is strategically positioning itself ahead of a critical Phase 2a data readout for nimacimab, their first-in-class peripheral CB1 antibody for obesity. The scheduled KOL event featuring obesity experts serves as an important pre-data educational session to set appropriate expectations for investors before the actual results are released.

The timing and structure of this event are particularly noteworthy. By hosting prominent experts to discuss what constitutes success in this proof-of-concept study, Skye is establishing the evaluation framework for their upcoming data. This suggests management has confidence in their program and wants to ensure the market properly understands how to interpret the results when released.

Nimacimab's mechanism - peripheral CB1 inhibition - represents a differentiated approach in the increasingly competitive obesity treatment landscape. Unlike GLP-1 agonists that dominate current obesity treatment, CB1 inhibition works through a completely different pathway. The emphasis on both safety parameters (gastrointestinal outcomes and neuropsychiatric considerations) highlights Skye's awareness of historical challenges with CB1 modulators while suggesting their peripheral-acting approach may overcome previous limitations.

The announcement of "newly generated preclinical data" to be shared indicates ongoing mechanistic validation work that could strengthen nimacimab's scientific foundation. Most importantly, CEO Dhillon's statement that this event will "outline the potential of nimacimab to advance into Phase 2b development" signals the company's forward-looking confidence while carefully managing expectations by explicitly stating they "are not previewing clinical results."

For investors, this event represents an important milestone that sets the stage for the actual data readout, which will be a binary event determining whether nimacimab advances to later-stage development in the lucrative obesity market.

Virtual KOL event will begin at 8:00 AM ET on Thursday, September 4, 2025

SAN DIEGO, Aug. 27, 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 virtual KOL event, titled “Expert Panel on Peripheral CB1 Inhibition as a Mechanism for Weight Loss,” on Thursday, September 4^th at 8:00 AM ET, to discuss expectations and details of upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, a first-in-class peripheral CB1 antibody for obesity.

Advanced Registration - Registration is required to participate in the webcast and can be completed by clicking here. The presentation and a replay of the call will also be available on the Company’s website.

KOL Event Highlights - The event will feature distinguished obesity key opinion leaders and will cover expectations and details of the upcoming Phase 2a CBeyond™ topline results readout including:

• What constitutes success in Skye’s Phase 2a proof-of-concept study
• Mechanism and potential role of peripheral CB1 inhibition as a differentiated and complementary anti-obesity therapeutic pathway to other mechanisms of action
• Highlights of newly generated preclinical data with nimacimab
• Q&A session.

Skye’s Chief Executive Officer, Punit Dhillon commented, “This KOL event is about clarity ahead of CBeyond’s Phase 2a topline data and we are delighted to feature a discussion between management and leading clinical and scientific experts. The dialogue will serve to frame what constitutes success in this proof-of-concept study, discuss the important considerations of safety and tolerability, notably gastrointestinal outcomes, which are an important benchmark in the obesity field, and neuropsychiatric considerations that are pertinent to the CB1 class, and highlight how we will read the data against nimacimab’s target product profile. We’ll also share new preclinical insights that inform our translational view. We are not previewing clinical results, however, together, these insights will outline the potential of nimacimab to advance into Phase 2b development and shape its role within the evolving obesity treatment landscape.”

Featured KOL Speakers

Kevin Cannon, MD, is a board-certified internist who earned his medical degree and completed his residency in internal medicine at the Medical College of Virginia. He has practiced as a hospitalist for more than 25 years and has been actively engaged in clinical research for 18 years. Dr. Cannon has served as principal investigator on 50+ metabolic studies — spanning obesity, diabetes, cachexia, and sarcopenia — and has partnered with more than 10 industry sponsors over the past decade in the metabolic space. His extensive inpatient experience gives him a deep, practical understanding of the cardiovascular and systemic consequences of obesity and metabolic syndrome and drives his commitment to help develop treatments that improve long-term patient outcomes.

Sean Wharton, MD, FRCPC, PharmD, has his doctorate in pharmacy and medicine from the University of Toronto in Canada. He practices internal medicine and is the director of the Wharton Medical Clinic, a community-based weight management and diabetes clinic. He is an assistant professor at the University of Toronto and adjunct professor at McMaster and York University. He is the lead author of the 2020 Canadian Obesity Guidelines, which has been recognized around the world, and has published many peer-reviewed articles in international medical journals.

Dr. Wharton is involved in advocacy to achieve health equity in medicine.

Marcus Goncalves, MD, PhD, 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.

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 2a 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: https://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. 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

When is Skye Bioscience (SKYE) hosting its KOL event for CBeyond Phase 2a results?

Skye Bioscience will host the virtual KOL event on Thursday, September 4, 2025, at 8:00 AM ET.

What is nimacimab and what is SKYE developing it for?

Nimacimab is a first-in-class peripheral CB1 antibody being developed by Skye Bioscience for the treatment of obesity.

Who are the key opinion leaders participating in SKYE's virtual event?

The event will feature Dr. Kevin Cannon (internist with 18+ years in clinical research), Dr. Sean Wharton (lead author of 2020 Canadian Obesity Guidelines), and Dr. Marcus Goncalves (Associate Professor at NYU Langone Health).

What topics will be covered in Skye Bioscience's KOL event?

The event will cover success criteria for the Phase 2a study, mechanism of peripheral CB1 inhibition, new preclinical data, safety considerations including gastrointestinal and neuropsychiatric outcomes, and nimacimab's potential role in obesity treatment.

How can investors attend SKYE's virtual KOL event?

Investors must register in advance to participate in the webcast. A presentation and replay will also be available on the company's website.