SKYE SKYE BIOSCIENCE INC

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

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

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 4th 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 . The presentation and a replay of the call will also be available on the Company’s .

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 () 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: . Connect with us on and .

CONTACTS

Investor Relations



(858) 410-0266

LifeSci Advisors, Mike Moyer



(617) 308-4306

Media Inquiries

LifeSci Communications, Michael Fitzhugh



(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.



EN
27/08/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on SKYE BIOSCIENCE INC

 PRESS RELEASE

Skye Reports Positive CBeyond Phase 2a Extension Interim Study Results...

Skye Reports Positive CBeyond Phase 2a Extension Interim Study Results for Nimacimab in Combination With Semaglutide 22.3% total weight loss at 52 weeks with nimacimab (200 mg dose) + semaglutide (2.4 mg) combination — no plateau observed, suggesting potential for further efficacy beyond one year and at higher nimacimab dosesWeight regain during treatment interruption reduced by over 50% — nimacimab + semaglutide cohort regained only 17.8% of lost weight vs. 37.3% for semaglutide alone during 13-week off-therapy follow-up, demonstrating durability advantageStrong safety and tolerability pro...

 PRESS RELEASE

Skye Bioscience Highlights Attributes of its Peripherally-restricted C...

Skye Bioscience Highlights Attributes of its Peripherally-restricted CB1 Inhibitor Antibody at Keystone Obesity Conference SAN DIEGO, Jan. 29, 2026 (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 presented a poster titled "Investigating the Efficacy of Nimacimab Alone or in Combination with Tirzepatide, and as a Maintenance Therapy Post Tirzepatide Discontinuation in a Diet-Induced Obesity (DIO) Mouse Model" at Keystone’s conference...

 PRESS RELEASE

Skye Bioscience to Present Poster at Keystone Obesity Conference

Skye Bioscience to Present Poster at Keystone Obesity Conference SAN DIEGO, Jan. 21, 2026 (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 present a poster at Keystone’s conference, Obesity Therapeutics: Unlocking Benefits and Minimizing Side Effects. Skye’s presentation addresses the following questions regarding the ability of its peripherally-restricted CB1-inhibitor antibody: Can nimacimab enhance optimal and suboptimal doses of...

 PRESS RELEASE

Skye Provides 2026 Corporate Outlook

Skye Provides 2026 Corporate Outlook CBeyondTM Phase 2a 26-week extension data update and interim results expected Q1 2026. CBeyond Phase 2a Data Monitoring Committee (DMC) meeting on December 14, 2025, continued to demonstrate favorable safety profile.CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026. Phase 2b (CBeyond 2) plan to be finalized in Q1; trial launch targeted for Q3 2026. SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”) a clinical-stage biotechnology company focused on unl...

 PRESS RELEASE

Halozyme and Skye Bioscience Announce Global Collaboration and License...

Halozyme and Skye Bioscience Announce Global Collaboration and License Agreement to Evaluate Nimacimab Co-Formulated with ENHANZE® for Obesity Agreement supports development and commercialization of higher-dose, subcutaneous administration strategies for nimacimab SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Skye Bioscience, Inc. (Nasdaq: SKYE) today announced the companies entered into a non-exclusive global collaboration and license agreement in December 2025. Under the collaboration, Skye has licensed Halozyme's ENHANZE® drug delivery te...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch