Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting

Novel CB1 inhibitor Phase 1b data highlights lack of neuropsychiatric adverse events and favorable gastrointestinal tolerability

SAN DIEGO, Sept. 19, 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 presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.

The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts. Importantly, there were no serious adverse events, no discontinuations due to adverse events, and no evidence of neuropsychiatric safety signals. Gastrointestinal side effects were infrequent and mild, underscoring the potential differentiated tolerability profile of this peripheral CB1-inhibiting antibody.

“These Phase 1b results provide an early glimpse of the benchmark safety and tolerability profile that we believe sets nimacimab apart within the broader anti-obesity medicine landscape,” said Puneet Arora, MD, MS, FACE, Chief Medical Officer of Skye Bioscience. “Obesity is a multi-factorial disease with overlapping pathways across key organs including the liver, adipose tissue, and muscle. While our immediate focus is on the upcoming topline readout from our CBeyond™ Phase 2a obesity study, these favorable findings in an obese, diabetic MASLD population help establish nimacimab’s potential role in the treatment of metabolic diseases.”

This Phase 1b study was previously conducted by Bird Rock Bio, Inc., which Skye acquired in 2023.

The presentation, made in the oral category session called “New medications on the horizon?”, was titled “A multiple dose study to evaluate the safety and tolerability of nimacimab, a peripherally restricted, inhibitory CB1 receptor antibody in subjects with metabolic associated fatty liver disease (MAFLD).” The slides are available on Skye’s website on the Spotlight page.

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: 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,” “potential” or the negative of these terms or other comparable terminology. These forward looking statements include, but are not limited to: statements relating to any expectations regarding the efficacy and therapeutic potential of nimacimab as a monotherapy or in combination with a GLP-1 targeted drug or other incretin drugs, statements regarding the potential of CB1 inhibition to address certain unmet needs of patients on GLP-1 weight loss drugs, statements regarding the timing of receipt of data from Skye’s Phase 2a obesity study, including its extension study, statements regarding the ability of nimacimab to perform in humans in a manner consistent with preclinical DIO data, statements regarding the potential market opportunities of nimacimab and statements regarding nimacimab’s potential to have a superior safety and tolerability profile compared to the small molecules like monlunabant,. 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 that could cause our actual results to differ materially from those expressed or implied by such forward-looking statements. 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. Risks and uncertainties that may cause actual results to differ materially include, among others: that preclinical data are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trial of nimacimab, including the Phase 2a study of nimacimab, competition from third parties that are developing products for similar uses, Skye’s ability to obtain, maintain and protect its intellectual property, Skye’s dependence on third parties for development and manufacture of product candidates, Skye’s ability to manage expenses and to obtain additional funding when needed to support its business activities, as well as those risks more fully described in the section entitled “Risk Factors” 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.

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