Skye Bioscience Partners with Arecor Therapeutics to Enhance Nimacimab Formulation for Obesity Treatment

Skye Bioscience partners with Arecor to develop nimacimab's formulation for obesity treatment, enhancing efficacy and patient compliance.

Quiver AI Summary

Skye Bioscience, Inc. has announced a collaboration with Arecor Therapeutics plc to develop a higher concentration formulation of its CB1 inhibitor, nimacimab, utilizing Arecor's Arestat™ formulation technology. This initiative aims to improve nimacimab, which is currently being evaluated in a Phase 2a CBeyond™ clinical trial for obesity. The results from this study's initial treatment period are expected in late Q3 or early Q4 2025. Under the partnership, Skye will finance Arecor's development efforts and has the option to license the new formulation and related intellectual property for further development and commercialization. Both companies expressed optimism about the collaboration's potential to enhance patient compliance and address unmet needs in metabolic health.

Potential Positives

• Skye Bioscience announced a collaboration with Arecor Therapeutics to develop a higher concentration formulation of their CB1 inhibitor, nimacimab, potentially enhancing its therapeutic efficacy.
• The partnership leverages Arecor's proprietary formulation technology, Arestat™, which could lead to improved patient outcomes and increased market competitiveness for nimacimab.
• Nimacimab is currently being evaluated in a Phase 2a clinical trial targeting obesity, with initial data expected by late Q3 or early Q4 2025, indicating continued progress in clinical development.
• Skye aims to address significant unmet needs in metabolic health with nimacimab, which has been highlighted as a promising candidate due to its favorable pharmacokinetic profile and dosing schedule.

Potential Negatives

• The press release emphasizes the company's reliance on a partnership with Arecor Therapeutics, which may highlight a lack of in-house capabilities or confidence in developing the formulation independently.
• Forward-looking statements regarding the approval and efficacy of nimacimab carry inherent risks and uncertainties, which could negatively impact the company’s credibility and stock price if expectations are not met.
• The mention of potential issues with existing approved weight loss drugs may imply a challenging competitive landscape and the need for Skye to validate nimacimab's safety and effectiveness against these concerns.

FAQ

What is the purpose of Skye's collaboration with Arecor Therapeutics?

The collaboration aims to develop a higher concentration formulation of nimacimab using Arecor’s Arestat™ technology.

What is nimacimab and its significance?

Nimacimab is a first-in-class CB1-inhibiting monoclonal antibody being evaluated for obesity in Skye's Phase 2a CBeyond™ trial.

When is the data from the Phase 2a trial expected?

Data from the initial 26-week treatment period is anticipated in late Q3 or early Q4 2025.

How does nimacimab compare to other weight loss drugs?

Nimacimab has a favorable pharmacokinetic profile and does not exhibit neuropsychiatric toxicity concerns associated with small molecule CB1 inhibitors.

What are the potential benefits of the new formulation of nimacimab?

The enhanced formulation aims to improve patient compliance and treatment outcomes for obesity and metabolic health disorders.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$SKYE Insider Trading Activity

$SKYE insiders have traded $SKYE stock on the open market 4 times in the past 6 months. Of those trades, 0 have been purchases and 4 have been sales.

Here’s a breakdown of recent trading of $SKYE stock by insiders over the last 6 months:

• PAUL A. GRAYSON sold 86,244 shares for an estimated $430,357
• PUNIT DHILLON (Chief Executive Officer) sold 82,546 shares for an estimated $411,904
• KAITLYN ARSENAULT (Chief Financial Officer) sold 43,206 shares for an estimated $215,597
• TUAN TU DIEP (Chief Development Officer) sold 19,489 shares for an estimated $97,250

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• POINT72 ASSET MANAGEMENT, L.P. removed 416,424 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $1,178,479
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Full Release

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,


www.arecor.com


.

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 (


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


.

SKYE 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

ARECOR CONTACTS

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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.