SKYE SKYE BIOSCIENCE INC

Skye Bioscience Establishes Partnership with Arecor Therapeutics to Develop Enhanced Formulation of Obesity Candidate Nimacimab

Skye Bioscience Establishes Partnership with Arecor Therapeutics to Develop Enhanced Formulation of Obesity Candidate Nimacimab

Proprietary formulation technology being applied to potentially enhance properties of nimacimab

SAN DIEGO, May 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 a formulation development collaboration with Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today’s therapies to enable healthier lives. The partnership aims to develop a higher concentration formulation of Skye’s CB1 inhibitor, nimacimab, using Arecor’s proprietary formulation technology platform, Arestat™.

Skye is evaluating nimacimab, a first-in-class CB1-inhibiting monoclonal antibody, in its Phase 2a CBeyond™ clinical trial in patients with obesity and overweight. Data from the initial 26-week treatment period is anticipated in late Q3 or early Q4 2025.

Under the terms of the agreement, Skye will fund Arecor’s development activities with the option to license rights to the new proprietary formulation of nimacimab and associated intellectual property to further develop and commercialize the product.

Sarah Howell, Chief Executive Officer of Arecor, said: “We are pleased to partner with Skye to support the development of a novel, enhanced formulation of nimacimab, a promising first-in-class candidate with the potential to address significant unmet needs in metabolic disease. This collaboration highlights the strength of our proprietary Arestat™ technology in enabling the development of enhanced therapeutic products that can improve patient outcomes and supports our strategy of bringing innovative medicines to market that address significant unmet patient needs in high-value markets.”

Tu Diep, Chief Operating Officer of Skye, said: “Approved weight loss drugs have issues with tolerability and adherence, while the small molecule CB1 inhibitors raise concerns about cumulative exposure-related neuropsychiatric toxicities. Nimacimab already has an advantageous pharmacokinetic profile and to date it does not pose these issues. It has a potentially best-in-class half-life of 18–21 days--substantially longer than GLP-1-based therapies--and is being evaluated in a Phase 2a study with once-weekly dosing. Serving our goal of continuous innovation, we are pleased to work with Arecor on the goal of further enhancing nimacimab to improve patient compliance and treatment outcomes.”

About Arecor

Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. For further details please see our website, .

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 therapeutic candidates 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 .

SKYE CONTACTS

Investor Relations



(858) 410-0266

LifeSci Advisors, Mike Moyer



(617) 308-4306

Media Inquiries

LifeSci Communications, Michael Fitzhugh



(628) 234-3889

ARECOR CONTACTS

Arecor Therapeutics plc
Dr Sarah Howell, Chief Executive OfficerTel: +44 (0) 1223 426060

Email:
David Ellam, Interim Chief Financial OfficerTel: +44 (0) 1223 426060

Email:
  
Singer Capital Markets Advisory LLP (NOMAD and Joint Broker) 
Phil Davies, Sam ButcherTel: +44 (0) 20 7496 3000
  
WG Partners LLP (Joint Broker) 
Nigel Barnes, Satheesh Nadarajah

David Wilson, Claes Spang
Tel: +44 (0) 20 3705 9321
  
ICR Healthcare 
Chris Gardner, David Daley, Lindsey NevilleTel: +44 (0) 20 3709 5700

Email:



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. These forward looking statements include, but are not limited to statements regarding the pharmacokinetic and pharmacodynamic profile of nimacimab and statements regarding the timing of receipt of final data from Skye’s Phase 2 obesity study of nimacimab. 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
19/05/2025

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