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Skye is limitless

Unlocking new therapeutic pathways for metabolic health

Nasdaq: SKYE

We are a biotechnology company developing next-generation drugs to treat obesity and other metabolic diseases.

Our focus is on advancing first-in-class molecules that modulate G-protein coupled receptors with the potential to provide enhanced health outcomes for diseases with significant prevalence and unmet needs.

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Obesity & CB1 Inhibition

The obesity landscape awaits differentiated therapeutic mechanisms to help patients achieve healthier, sustainable weight loss and improve related metabolic conditions

Current anti-obesity therapeutics are spotlighting the need for solutions to achieve persistent weight loss outcomes, improved body composition and better drug tolerability. Peripheral CB1 inhibition, an alternative mechanism that is complementary to other weight loss therapeutic mechanisms, directly affects metabolic processes that can increase energy expenditure and burn stored fat, improve leptin sensitivity and modulate peripheral signaling that influences appetite and feelings of fullness. CB1 inhibition has been previously clinically validated and approved for use in obesity in Europe. It represents a promising path to potentially broaden achievable therapeutic outcomes to serve the large and heterogeneous obesity market.

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Pipeline

MOA Disease
R&D Phase 01 Phase 02
CB1 Receptor Inhibitor Obesity
R&D Phase 01 Phase 02
Started P2 Aug 2024
Nimacimab
Data readout 2025
Phase 2: Nimacimab 01

01 Nimacimab is a first-in-class peripheral CB1-inhibiting antibody being developed to realize the differentiated mechanism of action and clinical outcomes that would position CB1 inhibition as an anti-obesity therapeutic that is complementary to current approved drugs. Targeting the CB1 receptor in peripheral tissue including adipose, liver, and muscle, with an extremely limited presence in the CNS, nimacimab offers the prospect of directly increasing energy expenditure to cause fat breakdown with better gastrointestinal tolerability and muscle preservation, and a more sustainable weight loss result. Nimacimab achieved a positive tolerability and Phase 1 safety profile, with no neuropsychiatric adverse events. Its unique binding to the CB1 receptor may result in a broader therapeutic window and it offers the potential for once-a-week to once-a-month drug administration, a positive for patient adherence. Skye started its CBeyondTM obesity Phase 2 study in August 2024, with data readouts in 2025.

News and Media

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Skye Bioscience Reports Topline CBeyond™ Phase 2a Data from Nimacimab Monotherapy and Combination Clinical Trial
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Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting
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Skye’s CB1 Inhibitor, Nimacimab, Demonstrates Superior Weight Loss and Differentiated Mechanisms from Monlunabant, and Continues to Show Enhanced Combination with Tirzepatide with Durable Post-Treatment Weight Maintenance in DIO Model
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Skye Completes 26-week Treatment Phase in Phase 2a CBeyond™ Study
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Skye Bioscience to Host Virtual KOL Event and Provide Perspectives on Upcoming CBeyond™ Phase 2a Topline Clinical Data Readout
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Skye Bioscience to Participate in Upcoming Investment and Medical Conferences
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Skye Bioscience Reports Second Quarter 2025 Financial Results and Business Update
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Skye Bioscience to Announce Second Quarter 2025 Financial Results and Business Update on August 7, 2025
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Skye Bioscience Shares Nimacimab “Anatomy of Progress” Video Series and Highlights Preclinical CB1 Antibody Data Presented at the American Diabetes Association’s 85th Scientific Sessions
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