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SKYE BIOSCIENCE INC (Nasdaq: SKYE) is a biotechnology company headquartered in San Diego, California. Established in 2011, SKYE focuses on developing peripherally-restricted CB1 receptor inhibitors for the treatment of obesity and related metabolic diseases. Its lead candidate, nimacimab, is being evaluated in Phase 2 clinical trials both as a monotherapy and in combination with a GLP-1 receptor agonist (Wegovy®).
Corporate Structure
SKYE BIOSCIENCE employs between 11 and 50 people, including executives with extensive life-science experience. President and Chief Executive Officer Punit Dhillon has led the company since 2020 and has over 20 years of industry and investment expertise. Under his leadership, SKYE completed the acquisition of its CB1 inhibitor and raised more than $500 million in capital as of the latest filings.
Biotechnology by Sangharsh Lohakare
Recent Developments and News
- On August 7, 2025, SKYE filed a Form 8-K (Items 2.02 and 9.01) with the U.S. Securities and Exchange Commission, reporting material events and corporate updates.
- On August 14, 2025, Schonfeld Strategic Advisors LLC amended its Schedule 13G/A, disclosing beneficial ownership of 1,115,939 shares, representing 3.60% of common stock as of June 30, 2025.
- At the European Association for the Study of Diabetes Annual Meeting on September 15, 2025, SKYE presented Phase 1b results indicating that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics with low immunogenicity in subjects with metabolic-associated steatotic liver disease.
- Preclinical studies reported on September 30, 2025, demonstrated that nimacimab reduced post-treatment weight rebound and provided weight-loss benefits in diet-induced obesity (DIO) models.
- SKYE continues its Phase 2 trial (ClinicalTrials.gov: NCT06577090), which began in August 2024. Topline data are expected in late Q3 or early Q4 2025.
Financial and Strategic Analysis
A summary of SKYE’s key financial metrics as of the market close on October 6, 2025:
| Metric | Value |
|---|---|
| Share Price | $2.01 |
| Daily Change | –57.68% |
| Volume | 326,150 |
| Market Capitalization (intraday) | $147.2 million |
| Enterprise Value | $90.9 million |
| Trailing EPS (TTM) | –$1.06 |
| Net Income (TTM) | –$42.4 million |
| Total Cash (MRQ) | $48.6 million |
| Total Debt/Equity (MRQ) | 0.84% |
SKYE is currently not profitable, which is consistent with its R&D-intensive pipeline. The company’s cash position is intended to support ongoing trials until the anticipated data readout. Strategically, nimacimab’s peripherally-restricted mechanism aims to address side effects associated with earlier CB1 inhibitors. The trial's combination arm with a GLP-1 agonist seeks to utilize complementary pathways for fat reduction and metabolic health.
Market Position and Industry Context
Obesity prevalence in the U.S. has increased from approximately 13% in the 1960s to nearly 75% of adults in 2025. Analysts project that the global weight-loss pharmaceutical market could exceed $100 billion by 2030. While GLP-1 receptor agonists have gained acceptance in treatment regimens, challenges remain due to side effects, variable patient responses, and concerns of muscle loss. CB1 receptor inhibition targets metabolic processes directly, potentially reducing fat storage, increasing energy expenditure, and lowering inflammation. SKYE’s nimacimab represents a novel approach by operating outside the blood-brain barrier, intending to complement existing therapies.
TL;DR
On October 6, 2025, SKYE BIOSCIENCE shares closed at $2.01, reflecting a decrease of 57.68%. The company expects Phase 2 nimacimab topline data in late Q3 or early Q4 2025. Recent SEC filings include an 8-K on August 7 and a Schedule 13G/A amendment on August 14 indicating a 3.60% stake by Schonfeld Strategic Advisors. Phase 1b results regarding metabolic-associated steatotic liver disease were presented on September 15, and preclinical DIO studies reported on September 30 support nimacimab’s benefits. The next key milestone is the Phase 2 data readout in the upcoming quarter.
