Advancing Leading Differentiated Obesity Medicines
Company Overview
Skye Bioscience (Nasdaq: SKYE) is dedicated to developing new treatments that help reduce excess body fat and improve metabolic health. While current weight loss medications have achieved important therapeutic outcomes, they don’t work well for everyone due to side effects and varying response rates—leaving significant gaps in care. Skye is working to address these challenges by targeting well-proven biological pathways in the body with strong evidence in humans. Its first-in-class therapeutic has potential to address unmet needs in obesity left by GLP-1 and incretin pharmaceuticals.
Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, its differentiated peripherally-restricted CB1 inhibitor. The study is assessing nimacimab as a monotherapy and also the combination of nimacimab with a GLP-1 receptor agonist (Wegovy®). Skye expects to report topline data in late Q3 or early Q4 2025.
Welcome to Skye Bioscience from CEO Punit Dhillon
Watch Video NowThe Big “Fat” Problem
The Growing Obesity Market – Obesity prevalence in the US was about 13% in the 1960s. In 2025, nearly 3 in 4 adults in the U.S. are dealing with overweight or obesity. Analysts have projected that the weight loss pharmaceutical market will exceed $100B in potential sales by 2030.
Weight is an Issue, but the Critical Problem is Excess Fat – Beyond the physical effects of excess weight and related social stigma, excess fat can cause important detrimental long-term biological effects. The body’s metabolic system involves chemical processes that turn food into energy and store unused energy as fat. Excess fat—especially around abdominal organs—triggers inflammation that can cascade into metabolic dysfunction, cardiovascular diseases, and other conditions. This makes fat reduction—not simply weight loss—critical to achieving longevity and health.
Available Treatments are Impactful but Imperfect – Today’s prominent approved weight loss drugs supplement the body’s natural GLP-1 hormone production to reduce hunger in order to burn fat. Typically, a key indicator of the effectiveness of these medicines is absolute weight loss. This metric alone ignores the fact that these drugs can also trigger gastrointestinal issues and excess muscle loss. Patients often drop off these drugs early and regain weight. Some patients don’t respond to this class of drug at all.
Ideally, new pharmaceutical approaches could complement and reduce the limitations of GLP-1 and incretin anti-obesity drugs through other mechanisms to achieve healthier, sustainable fat reduction and improved metabolic health. Skye’s novel CB1-inhibiting antibody is being developed to potentially provide an alternative treatment choice to doctors and patients.
Read: Empowering the Body’s Fat-Burning Potential via CB1 InhibitionEnhancing 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.
Read: The Unique Attributes of Skye’s CB1 InhibitorNimacimab’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.
Read: Skye FactsSkye 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.
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IR Contacts
Headquarters
Skye Bioscience, Inc.
11250 El Camino Real
Suite 100
San Diego, CA 92130
Investor Relations
SKYE Investor Relations
T: (858) 410-0266
ir@skyebioscience.com
Transfer Agent
Broadridge Corporate Issuer Solutions, LLC
P.O. Box 1342
Brentwood, NY 11717
T: 303-974-3386
shareholder@broadridge.com
https://www.shareholder.broadridge.com
Forward Looking Statements
The information above 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. Forward–looking statements may be identified by the use of words such as "estimate," "plan," "goal," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target," "opportunity" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward–looking statements include, but are not limited to: statements concerning Skye's future plans and prospects, any expectations regarding the safety, efficacy, tolerability or combinability of nimacimab, including based on preclinical and clinical information from the nimacimab Phase 1 study in NAFLD or from preclinical DIO studies, the timing of the receipt of final data from our clinical studies, the potential market opportunities, the timing and clinical strategy for nimacimab, the planned timing of Skye's anticipated milestones for nimacimab and the company's cash runway. Forward–looking statements are neither historical facts nor assurances of future performance. Although Skye believes the expectations reflected in such forward–looking statements are reasonable, Skye can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Skye's forward looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to completion of Skye's phase 2 study for nimacimab, Skye's ability to advance nimacimab, obtain regulatory approval of and ultimately commercialize nimacimab, competitive products or approaches limiting the commercial value of nimacimab, Skye's ability to fund development activities and achieve development goals, the impact of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on Skye's business, Skye's ability to protect its intellectual property and other risks and uncertainties described in Skye's most recent Annual Report on Form 10–K and future reports Skye may file with the Securities and Exchange Commission from time to time. All forward–looking statements contained in this presentation speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Skye undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.