SKYE SKYE BIOSCIENCE INC

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

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, 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:

  • Can nimacimab enhance optimal and suboptimal doses of incretin agonists?
  • How durable is nimacimab’s effect on weight loss after treatment discontinuation?
  • Can nimacimab be used as a maintenance therapy after tirzepatide discontinuation?
  • Is caloric-restriction the primary mechanism of nimacimab-driven weight loss?



Key takeaways from the DIO studies:

  • Nimacimab showed significant additive weight loss effects when combined with suboptimal or clinically active dose levels of tirzepatide (39% and 46% weight loss respectively).
  • Nimacimab weight loss was durable after treatment discontinuation.
  • Nimacimab treatment after tirzepatide discontinuation improved the weight rebound profile (regain blunted by ~80%).
  • Nimacimab weight loss was not primarily driven by caloric restriction.
  • Nimacimab enhanced weight loss induced by semaglutide.



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 the .

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 () 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 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 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.



EN
29/01/2026

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