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Skye Bioscience to Present Expanded Preclinical CB1 Antibody Data at the American Diabetes Association’s 85th Scientific Sessions

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Skye Bioscience (NASDAQ: SKYE) will present new preclinical data for its CB1 inhibitor nimacimab at the American Diabetes Association's 85th Scientific Sessions from June 20-23, 2025, in Chicago. The company will showcase its research through multiple presentations including an Evercore panel, an Innovation Hub symposium, and a poster presentation. The symposium will focus on nimacimab's mechanism of action in weight loss and metabolic regulation, highlighting its potential as a non-incretin-based therapeutic option. The poster presentation will demonstrate nimacimab's effects on metabolic homeostasis in diet-induced obesity mouse models, showing promising results in weight loss, hormonal regulation, and inflammatory biomarker reduction. The research emphasizes peripheral CB1 inhibition as a safe approach to modulate metabolic parameters.
Skye Bioscience (NASDAQ: SKYE) presenterà nuovi dati preclinici sul suo inibitore CB1, nimacimab, durante la 85ª Sessione Scientifica dell'American Diabetes Association, che si terrà dal 20 al 23 giugno 2025 a Chicago. L'azienda illustrerà le sue ricerche attraverso diverse presentazioni, tra cui un panel Evercore, un simposio dell'Innovation Hub e una presentazione poster. Il simposio si concentrerà sul meccanismo d'azione di nimacimab nella perdita di peso e nella regolazione metabolica, evidenziando il suo potenziale come opzione terapeutica non basata su incretine. La presentazione poster mostrerà gli effetti di nimacimab sull'omeostasi metabolica in modelli murini di obesità indotta da dieta, evidenziando risultati promettenti nella perdita di peso, nella regolazione ormonale e nella riduzione di biomarcatori infiammatori. La ricerca sottolinea l'inibizione periferica del CB1 come un approccio sicuro per modulare i parametri metabolici.
Skye Bioscience (NASDAQ: SKYE) presentará nuevos datos preclínicos de su inhibidor CB1, nimacimab, en las 85ª Sesiones Científicas de la American Diabetes Association, que se celebrarán del 20 al 23 de junio de 2025 en Chicago. La compañía mostrará su investigación mediante múltiples presentaciones, incluyendo un panel de Evercore, un simposio del Innovation Hub y una presentación de póster. El simposio se centrará en el mecanismo de acción de nimacimab en la pérdida de peso y la regulación metabólica, destacando su potencial como una opción terapéutica no basada en incretinas. La presentación de póster demostrará los efectos de nimacimab sobre la homeostasis metabólica en modelos murinos de obesidad inducida por dieta, mostrando resultados prometedores en la pérdida de peso, regulación hormonal y reducción de biomarcadores inflamatorios. La investigación enfatiza la inhibición periférica del CB1 como un enfoque seguro para modular los parámetros metabólicos.
Skye Bioscience(NASDAQ: SKYE)는 2025년 6월 20일부터 23일까지 시카고에서 열리는 미국 당뇨병 학회(ADA) 제85회 학술회의에서 CB1 억제제인 니마시맙(nimacimab)의 새로운 전임상 데이터를 발표할 예정입니다. 회사는 Evercore 패널, Innovation Hub 심포지엄, 포스터 발표 등 다양한 세션을 통해 연구 결과를 선보일 것입니다. 심포지엄에서는 니마시맙의 체중 감량 및 대사 조절 메커니즘에 초점을 맞추어, 인크레틴 기반이 아닌 치료 옵션으로서의 잠재력을 강조합니다. 포스터 발표에서는 식이 유도 비만 마우스 모델에서 니마시맙이 대사 항상성에 미치는 영향을 보여주며, 체중 감소, 호르몬 조절, 염증성 바이오마커 감소에서 유망한 결과를 제시합니다. 이 연구는 대사 지표 조절에 있어 안전한 접근법으로서 말초 CB1 억제를 강조합니다.
Skye Bioscience (NASDAQ : SKYE) présentera de nouvelles données précliniques sur son inhibiteur CB1, nimacimab, lors des 85èmes Sessions Scientifiques de l'American Diabetes Association, qui se tiendront du 20 au 23 juin 2025 à Chicago. La société exposera ses recherches à travers plusieurs présentations, notamment un panel Evercore, un symposium Innovation Hub et une présentation par affiche. Le symposium mettra l'accent sur le mécanisme d'action de nimacimab dans la perte de poids et la régulation métabolique, soulignant son potentiel en tant qu'option thérapeutique non basée sur les incrétines. La présentation par affiche démontrera les effets de nimacimab sur l'homéostasie métabolique dans des modèles murins d'obésité induite par l'alimentation, montrant des résultats prometteurs en matière de perte de poids, de régulation hormonale et de réduction des biomarqueurs inflammatoires. La recherche met en avant l'inhibition périphérique du CB1 comme une approche sûre pour moduler les paramètres métaboliques.
Skye Bioscience (NASDAQ: SKYE) wird neue präklinische Daten zu seinem CB1-Inhibitor Nimacimab auf den 85. Wissenschaftlichen Sitzungen der American Diabetes Association vom 20. bis 23. Juni 2025 in Chicago vorstellen. Das Unternehmen präsentiert seine Forschung in mehreren Beiträgen, darunter ein Evercore-Panel, ein Innovation Hub-Symposium und eine Posterpräsentation. Das Symposium konzentriert sich auf den Wirkmechanismus von Nimacimab bei Gewichtsverlust und metabolischer Regulation und hebt dessen Potenzial als nicht-incretinbasierte Therapieoption hervor. Die Posterpräsentation zeigt die Auswirkungen von Nimacimab auf die metabolische Homöostase in diätinduzierten Adipositas-Mausmodellen und präsentiert vielversprechende Ergebnisse bei Gewichtsreduktion, Hormonregulation und Reduktion inflammatorischer Biomarker. Die Forschung betont die periphere CB1-Hemmung als sicheren Ansatz zur Modulation metabolischer Parameter.
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SAN DIEGO, June 17, 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 that it was selected to present new nimacimab data in its expanded preclinical model at the upcoming American Diabetes Association’s (ADA) 85th Scientific Sessions. Skye will present in multiple forums at the ADA conference, which is being held June 20th – 23rd, 2025, at the McCormick Place Convention Center in Chicago, Illinois.

ADA Event Highlights:

  • Evercore Panel - Evercore hosted ADA panel participant (by invite-only)
  • Innovation Hub Symposium Presentation – “Mechanistic Insights into Weight Loss and Metabolic Regulation of Obese Mice Treated with Nimacimab, a Peripherally Restricted CB1 Inhibitor”
  • Poster Presentation – “Nimacimab, a Peripherally Restricted CB1 Inhibitor, Promotes Metabolic Homeostasis in a Diet-Induced Obesity (DIO) Mouse Model as Demonstrated by Weight Loss, Restored Hormonal Regulation, and Reduced Inflammatory Biomarkers”

These ADA presentations will all be available June 22nd, 2025.   

Summaries of ADA presentations:

Evercore Panel Presentation

Skye’s CEO, CMO and CSO will be a featured panel session speakers at Evercore’s invitation-only event being held in conjunction with ADA.

Symposium Presentation

Abstract Title: Mechanistic Insights into Weight Loss and Metabolic Regulation of Obese Mice Treated with Nimacimab, a Peripherally-restricted CB1 Inhibitor
   
Presenter: Chris Twitty, PhD, Skye Bioscience, Chief Scientific Officer
Location: Innovation Hub inside Exhibit   Hall, McCormick Place, Chicago
Date & Time: Sunday, June 22, 2025, 11:30-11:50am CT.
   

Summary: Non-incretin-based therapeutics represent an important clinical option for patients with obesity and other metabolic disorders. CB1 is a clinically validated G protein-coupled receptor target that plays a key role in energy homeostasis. There is growing consensus that peripheral inhibition of CB1 can safely modulate metabolic parameters, leading to meaningful weight loss. This presentation will highlight recent preclinical data that underscores key mechanisms supporting the therapeutic potential of Skye’s antibody-based peripherally- restricted CB1 inhibitor, nimacimab, including in vitro systems and in vivo diet-induced obesity models, both alone and in combination with incretin-based drugs like tirzepatide.

Poster Presentation

Title:   Nimacimab, a Peripherally Restricted CB1 Inhibitor, Promotes Metabolic Homeostasis in a Diet-Induced Obesity (DIO) Mouse Model as Demonstrated by Weight Loss, Restored Hormonal Regulation, and Reduced Inflammatory Biomarkers
   
Presenter:
 Shawn A. Morales, Skye Bioscience, Senior Clinical Research Scientist
Location:
 Presentation hall number 1716-P in category 23-A, Obesity—Animal.
Time:  Monday, Jun 23, 2025, 12:30 PM - 1:30 PM CT.
   

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 2 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” or the negative of these terms or other comparable terminology. 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.


FAQ

What will Skye Bioscience (SKYE) present at the ADA Scientific Sessions 2025?

Skye will present new preclinical data for nimacimab, their peripherally restricted CB1 inhibitor, through an Evercore panel, Innovation Hub symposium, and poster presentation focusing on weight loss and metabolic regulation in obesity models.

When and where will Skye Bioscience's ADA presentations take place?

The presentations will take place on June 22-23, 2025, at the McCormick Place Convention Center in Chicago, during the ADA's 85th Scientific Sessions.

What are the key findings from SKYE's nimacimab preclinical studies?

The studies show that nimacimab promotes metabolic homeostasis in diet-induced obesity mouse models, demonstrating weight loss, restored hormonal regulation, and reduced inflammatory biomarkers.

How does Skye Bioscience's nimacimab work for weight loss?

Nimacimab works as a peripherally restricted CB1 inhibitor that safely modulates metabolic parameters, targeting the CB1 receptor which plays a key role in energy homeostasis.

What makes SKYE's nimacimab different from other weight loss treatments?

Nimacimab represents a non-incretin-based therapeutic approach, offering a different mechanism of action through peripheral CB1 inhibition, and can be used alone or in combination with incretin-based drugs like tirzepatide.
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