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Enhancing the Body’s Fat-Burning Potential via CB1 Inhibition

Beyond Appetite: CB1 Inhibition Directly Leverages Metabolic Processes to Burn Fat - CB1 receptors are found in the brain and metabolically active tissues like fat, pancreas, liver, gut, and muscle. Think of CB1 as a "save energy" switch: it helped humans survive by making us hungry, storing unused energy from food as fat, and slowing how quickly we burned energy. Today, this survival system creates a perfect storm for weight gain.

Blocking the chemicals that activate CB1, CB1 inhibitors can directly improve metabolic processes that have become dysfunctional with obesity, reducing the storage of energy as fat, increasing energy use and fat breakdown, as well as lowering appetite. CB1 inhibitors also reduce inflammation that worsens obesity. Together, these effects help burn excess fat and improve long-term health. 

CB1 Inhibition: A Valuable Fat Loss Mechanism
Drug companies in the anti-obesity market are interested in new pharmaceutical mechanisms to complement GLP-1 drugs and have acquired or licensed multiple non-incretin (which encompass the GLP-1 mechanism) technologies. Since CB1 and GLP-1 are unique complementary receptors, CB1 inhibition has already been the target of a corporate acquisition. 

Skye’s CB1 Inhibitor is Distinct – The first CB1 inhibitors were small molecules with clinically-validated, significant weight loss that targeted fat over muscle. Because they have some exposure to the brain, in some cases they also affected the brain and caused unwanted mental health side effects.

Skye Bioscience’s nimacimab is unique in being a monoclonal antibody that works outside the brain. Nimacimab has shown notable weight and fat loss in preclinical studies and a favorable safety profile in a Phase 1 clinical trial.

Nimacimab’s Unique Attributes

Nimacimab is a monoclonal antibody that blocks CB1 receptors from the natural body chemicals that activate their role in the storage and consumption of fat, among other functions. Early CB1 inhibitors caused significant weight loss but entered the brain, risking mental health side effects. Nimacimab’s unique characteristics build on this mechanism with promising results to date. 

Monoclonal antibodies are too large to cross into the brain, and target only “peripheral” tissues like fat, the gut and the liver. Inhibiting CB1 in metabolically active tissues can reduce fat storage, boost fat use, and restore dysfunctional metabolic function. In preclinical testing, nimacimab alone drove 23.5% weight loss (mostly fat) and over 30% in combination with tirzepatide. Phase 1 revealed no safety issues.

Nimacimab is an injectable drug now being assessed using once-weekly administration; it has potential for monthly dosing. Nimacimab’s differentiation from GLP-1/incretin drugs such as Wegovy® and Zepbound® as well as early CB1 inhibitors uniquely position it as a product candidate for the obesity market.

Skye Executing on a Key Biotech Inflection Point, With Phase 2a Data Coming Soon – Skye completed enrollment for its 26-week Phase 2a trial of nimacimab ahead of schedule in February 2025. Topline data, expected in late Q3 or early Q4 2025, will assess efficacy for weight loss, body composition, and safety versus placebo, and also the first combination of a CB1 inhibitor with Wegovy®. This study has also been extended to 52 weeks of treatment in order to obtain longer-term insights.

Skye Facts

Novel Technology - Skye Bioscience stands apart in developing a novel antibody-based CB1 inhibitor to  complement and address certain shortcomings of GLP-1-based weight loss drugs. Skye is developing nimacimab for its potential as a standalone anti-obesity therapy or as a combination with a GLP-1-targeting therapeutic.

Team - Skye’s executive team has extensive biotech experience and is guided by a board of directors with deep pharmaceutical, biotechnology, entrepreneurial and venture capital expertise, as well as a clinical advisory board comprised of obesity specialists.  

Patents - We own patents granted in the U.S., Europe, Japan, Korea, China, and other jurisdictions that encompass compositions of matter for nimacimab and variant molecules, methods of treatment, and uses for treating obesity and related metabolic conditions. The current granted patents expire in  2035, excluding potential available patent term adjustments or extensions.

Key Investors – Specialist life science investors including 5AM Ventures and others have been integral in $107 million in capital raised by Skye since mid-2023.

Funding – Skye has an operating runway through at least Q1 2027.

History - Founded in 2014. Based in San Diego. Uplisted to NASDAQ in April 2024. Ticker symbol SKYE.