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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 Establishes Partnership with Arecor Therapeutics to Develop Enhanced Formulation of Obesity Candidate Nimacimab
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Skye Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
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Skye Bioscience Clinical Model Demonstrating Necessity of Peripheral CB1 Inhibition for Weight Loss Presented at European Congress on Obesity
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Skye Bioscience Reports First Quarter 2025 Results and Highlights Nimacimab Differentiation in Obesity
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Skye Bioscience to Announce 2025 First Quarter Financial Results on May 8th, 2025
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Skye Bioscience to Participate in May Investment and Medical Conferences
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Skye Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
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Skye Bioscience Demonstrates Over 30% Weight Loss with Nimacimab and Tirzepatide Combination in Preclinical Model
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Skye Bioscience to Conduct Meetings at Piper Sandler Conference
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