What Skye Bioscience does

Skye Bioscience, Inc. is a clinical-stage biotechnology company developing therapeutics targeting the endocannabinoid system, with a primary focus on obesity and metabolic diseases. The company's lead asset is nimacimab, a first-in-class peripheral CB1-inhibiting monoclonal antibody that uses allosteric modulation and is designed with very limited CNS penetration to avoid the neuropsychiatric adverse events associated with earlier small-molecule CB1 inhibitors. The technology is supported by dual drug-delivery collaborations — with Halozyme (ENHANZE for subcutaneous high-volume delivery) and Arecor (Arestat for high-concentration auto-injector formulation) — intended to enable weekly or monthly subcutaneous dosing at the higher doses required for obesity treatment.

The company operates a sales-led go-to-market posture oriented toward endocrinologists, obesity medicine specialists, and key opinion leaders via medical conferences (ObesityWeek, ADA, ECO, GLP-1 Summit), peer-reviewed publications, and investor communications. As a clinical-stage company, Skye has no commercial products and no product revenue; its economics are driven entirely by R&D expenditure, with a 2025 net loss of $55.9 million against a cash position of $17.1 million as of March 31, 2026. The CBeyond Phase 2a trial in obesity reported positive combination data (nimacimab plus semaglutide achieving 22.3% mean weight loss at 52 weeks with limited rebound) but the 200mg monotherapy arm failed its primary endpoint due to under-exposure relative to preclinical predictions, prompting a higher-dose expansion study initiated in April 2026.

The business model is a standard clinical-stage biotech equity-financing model: capital is raised through public equity (NASDAQ: SKYE) and private placements, with future revenue contingent on regulatory approval and prescription pharmaceutical distribution. The company faces material near-term risks including a Nasdaq minimum bid price deficiency notice (compliance deadline September 14, 2026), multiple securities fraud class action lawsuits related to alleged misstatements about nimacimab's efficacy, an employee stock option repricing to $0.6150 per share, and a cash runway that requires additional financing within approximately two quarters at the current burn rate.

Name

Skye Bioscience

Legal name

Skye Bioscience, Inc.

Website

https://skyebioscience.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Skye Bioscience is a clinical-stage biotechnology company developing nimacimab, a first-in-class peripheral CB1-inhibiting monoclonal antibody for obesity and metabolic diseases, with no commercial products or revenue.

Ownership category

akta.pro rank

Product category

Obesity and Metabolic Disease Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Obesity therapeutics
• CB1 receptor inhibition
• Monoclonal antibody drugs
• Metabolic disease treatment
• Clinical-stage biotechnology

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Drug Sales: Skye Bioscience is a clinical-stage biotechnology company with no current commercial products or revenue. The company is developing nimacimab, a peripheral CB1-inhibiting antibody for obesity and metabolic diseases. If successfully developed and approved by regulatory authorities, the company would generate revenue through the sale of prescription pharmaceutical products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Skye Bioscience is a clinical-stage biotechnology company developing nimacimab, a first-in-class peripheral CB1-inhibiting monoclonal antibody for the treatment of obesity and metabolic diseases. The company is advancing the drug through Phase 2 clinical trials (CBeyond), both as monotherapy and in combination with GLP-1 receptor agonists such as semaglutide, with the intent of obtaining regulatory approval for prescription pharmaceutical sales.

Product overview

Skye Bioscience is a clinical-stage biotechnology company developing next-generation drugs to treat obesity and other metabolic diseases. The company's primary product is nimacimab, a peripherally-restricted CB1-inhibiting monoclonal antibody in Phase 2 clinical development for obesity. Nimacimab is being evaluated both as monotherapy and in combination with GLP-1 receptor agonists (semaglutide/Wegovy) in the CBeyond Phase 2a trial. The company focuses on first-in-class molecules that modulate G-protein coupled receptors, with an emphasis on addressing unmet needs in the obesity market where current GLP-1 therapies have limitations related to gastrointestinal side effects, muscle loss, and weight rebound after treatment discontinuation.

Differentiator

Problem solved

Functional benefit

Products and services

• Nimacimab Nimacimab is a potentially first-in-class peripheral CB1-inhibiting monoclonal antibody being developed for obesity and metabolic diseases. It targets CB1 receptors in peripheral tissues including adipose, liver, and muscle, with very limited accumulation in the CNS, offering weight loss through increased energy expenditure, improved leptin sensitivity, and appetite modulation with better gastrointestinal tolerability and muscle preservation compared to GLP-1 therapeutics.

Quantifiable outcome

• 22.3% mean weight loss at 52 weeks with nimacimab + semaglutide combination therapy
• +5 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core and supporting.

• Halozyme TherapeuticscoreTechnology or Integration · 1 December 2025Non-exclusive global collaboration and license agreement to develop a subcutaneous formulation of nimacimab for obesity treatment using Halozyme's ENHANZE drug delivery technology. Skye will make milestone payments tied to development and commercialization achievements, while Halozyme will receive mid-single digit royalties on net sales for at least 10 years. Skye plans to initiate a Phase 2b clinical trial for nimacimab with ENHANZE in mid-2026, which will also assess combination with a GLP-1R agonist.
• Lilly Catalyze360supportingStrategic or Co-development Partner · 1 December 2025Engagement with Lilly Catalyze360 for Phase 2b trial design advisory services. The partnership provides strategic consulting for clinical trial design and development strategy for nimacimab.
• Arecor TherapeuticssupportingTechnology or IntegrationPartnership focused on achieving higher-concentration nimacimab formulations using Arecor's Arestat technology to enable simple, low-viscosity subcutaneous auto-injector delivery. This technology complements the ENHANZE partnership to address high-dose delivery challenges for obesity treatment.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Altimmune: Clinical-stage biotech developing pemvidutide, a GLP-1/glucagon dual agonist for obesity. Highly comparable to Skye as a similarly-sized, single-asset, pre-revenue obesity company navigating Phase 2 development with strategic optionality around partnership or acquisition.
• Zealand Pharma: Clinical-stage peptide company developing amylin analogs (e.g., BI 456906 with Boehringer Ingelheim) and other metabolic-disease candidates. Comparable as a small-cap, single-mechanism challenger pursuing differentiated obesity mechanisms against the GLP-1 incumbents.
• Structure Therapeutics: Clinical-stage company developing oral GLP-1 agonists (GSBR-1290) and other metabolic candidates. Similar profile to Skye: small-cap, single-platform, Phase 2 obesity focus with mechanism differentiation (oral vs. injectable).
• Keros Therapeutics: Clinical-stage biotech developing therapeutics targeting TGF-beta superfamily for hematologic and metabolic disorders. Comparable as a small-cap, single-mechanism biotech with clinical-stage assets in metabolic disease areas.

Broad incumbents

• Amgen: Large-cap biotech developing MariTide (AMG 133), an obesity candidate in Phase 2/3. Directly competes with nimacimab in the cardiometabolic/obesity space and represents the type of strategic acquirer Skye would likely need for commercial success.
• Eli Lilly: Market leader in incretin-based obesity therapeutics (tirzepatide/Zepbound, retatrutide). The dominant competitor any CB1-inhibitor must position against and a potential strategic partner interested in complementary mechanisms to its GLP-1 franchise.
• Novo Nordisk: Developer of semaglutide (Wegovy/Ozempic), the incumbent GLP-1 agonist and Skye's combination partner in the CBeyond trial. Sets the efficacy benchmark nimacimab must beat or complement to gain commercial relevance.
• Pfizer: Major pharma developing oral GLP-1 candidates (danuglipron) for obesity and metabolic disease. A potential strategic partner for Skye and a competitor for share-of-voice with endocrinologists and obesity specialists.

Emerging players

• Aardvark Therapeutics: Emerging clinical-stage company developing ARD-101 for Prader-Willi syndrome and other metabolic indications. Comparable as a small, single-asset biotech pursuing differentiated metabolic mechanisms with similar regulatory and capital-raising challenges as Skye.
• Vivani Medical: Clinical-stage company developing miniature, long-acting implants for chronic conditions including obesity (NPM-115). Comparable as a small-cap, single-asset, pre-revenue company pursuing differentiated obesity mechanisms in a GLP-1-dominated market.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/skyebioscience
• Facebookfacebook.com/skyebioscience
• LinkedInlinkedin.com/company/emeraldbioscience

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds10 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A3 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Skye Bioscience