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Skye Bioscience Highlights Attributes of its Peripherally-restricted CB1 Inhibitor Antibody at Keystone Obesity Conference

Key Takeaway: Skye Bioscience presented findings on its peripherally-restricted CB1 inhibitor, nimacimab, at the Keystone Obesity Conference. The studies suggest that nimacimab combined with lower doses of incretin agonists could provide a safer and effective treatment for obesity. The company is conducting a Phase 2a trial to further evaluate nimacimab's efficacy and safety.

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POSITIVE FACTORS

  • Nimacimab shows potential for a favorable safety profile.
  • Combination therapy may enhance long-term treatment adherence.
  • First-in-class design aims to limit neuropsychiatric side effects.

CONCERNS & RISKS

  • Future clinical trials depend on capital resources.
  • Regulatory approval and commercialization remain uncertain.

Full Press Release Details

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, Obesity Therapeutics: Unlocking Benefits and Minimizing Side Effects.
Skye’s presentation addressed the following questions regarding the ability of its peripherally-restricted CB1-inhibitor antibody:
Key takeaways from the DIO studies:
Chris Twitty, PhD, Chief Scientific Officer of Skye, who presented the poster, commented: “These findings suggest that nimacimab, when combined with lower and more tolerable incretin agonist doses, may achieve a favorable safety profile while still driving meaningful efficacy. This approach may help support longer treatment adherence and provide a more sustainable option for long-term weight management.”
Click here to see theposter.

About Nimacimab

Nimacimab is a potential first-in-class, peripherally-restricted monoclonal antibody inhibitor of the CB1 receptor. Unlike previous CB1-targeting drugs, nimacimab is designed to avoid central nervous system penetration, potentially limiting neuropsychiatric side effects seen with small-molecule antagonists. As a non-incretin, non-peptide agent, nimacimab acts independently of the GLP-1 pathway and has also demonstrated additive or complementary effects in combination with incretin-based therapies in preclinical and clinical studies.

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 onXandLinkedIn.

CONTACTS

Investor Relationsir@skyebioscience.com(858) 410-0266LifeSci Advisors, Mike Moyermmoyer@lifesciadvisors.com(617) 308-4306

Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@lifescicomms.com(628) 234-3889

FORWARD-LOOKING STATEMENTS

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: Skye's future plans and prospects, any expectations regarding the efficacy and therapeutic potential of nimacimab, including based on DIO models. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital needed to run an additional Phase 2 clinical trial, program considerations and potentially other factors outside the Company’s control; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab, competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Frequently Asked Questions

What is nimacimab?

Nimacimab is a peripherally-restricted monoclonal antibody that inhibits the CB1 receptor.

What were the key findings from the DIO studies?

The studies suggest nimacimab may achieve a favorable safety profile and enhance treatment adherence.

How does nimacimab differ from other CB1-targeting drugs?

Nimacimab is designed to avoid central nervous system penetration, reducing neuropsychiatric side effects.

What is the current status of nimacimab's clinical trials?

Skye is conducting a Phase 2a clinical trial to assess nimacimab's efficacy in obesity.

Last updated: Jan 29, 2026