Skye Bioscience Q3 2024 Financial Results and Highlights

SAN DIEGO, Nov. 07, 2024 - Skye Bioscience, Inc. (NASDAQ: SKYE), a clinical-stage biopharmaceutical firm spotlighting new therapeutic pathways for metabolic health, has announced its financial outcomes for the third quarter ending September 30, 2024. Additionally, the company highlighted significant recent achievements.

The third quarter of 2024 was transformative for Skye as it commenced its Phase 2 clinical trial targeting obesity with nimacimab. CEO Punit Dhillon emphasized the potential of nimacimab, a peripherally-restricted CB1 inhibitor, to offer unique benefits free from the neuropsychiatric side effects associated with central CB1 inhibition. This was underscored by new preclinical data showing significant weight loss in a diet-induced obesity (DIO) model in mice.

During the initial half of the year, Skye focused on strengthening its foundation through enhancements in personnel, capital, and systems. The company is now geared towards executing its clinical milestones in 2025, with interim Phase 2 data expected in Q2 2025.

Key Corporate and Clinical Highlights:

CBeyond Phase 2 Obesity Trial:
Skye began enrolling patients for its Phase 2 trial of nimacimab in August 2024. Nimacimab, a pioneering CB1-inhibiting monoclonal antibody, acts as both an inverse agonist and antagonist. The trial is designed to demonstrate an 8% difference in mean weight loss between nimacimab and placebo over 26 weeks, with a 13-week follow-up. Secondary and exploratory endpoints will assess safety, tolerability, neuropsychiatric outcomes, cognitive impact, and body composition changes via DEXA. The trial also evaluates the synergistic effects of combining nimacimab with semaglutide, a GLP-1 receptor agonist. Interim data from 50% of the planned 120 patients are anticipated in Q2 2025, with topline data expected by Q4 2025.

New Preclinical Data:
To further understand CB1 inhibition and the distinct aspects of nimacimab, Skye developed a novel DIO model. This model uses a transgenic mouse expressing the human CB1 receptor (hCB1R). The study revealed dose-dependent weight loss with nimacimab, achieving up to 16% weight loss compared to the vehicle. Additionally, significant fat mass reduction with lean mass preservation and improved glucose tolerance were noted. Preliminary results support the hypothesis that peripheral CB1 inhibition primarily drives weight loss, while central CB1 inhibition minimally contributes to efficacy but promotes neuropsychiatric adverse events.

Corporate Developments:
Skye appointed Dr. Puneet Arora, an endocrinologist with extensive metabolic experience, as Chief Medical Officer. Paul Grayson was named the new Chairman of the Board. Post-quarter, the United States Court of Appeals for the Ninth District vacated a judgment related to an outstanding litigation matter, allowing the company to recover $9 million in restricted cash, expected to be released by year-end.

Financial Highlights for Q3 2024:
Cash Position: Skye held $76.5 million in cash and equivalents, including $9.1 million in restricted cash, as of September 30, 2024. This capital is expected to fund operations through Q3 2027.
R&D Expenses: Research and development expenses rose to $4.9 million from $1.3 million in Q3 2023, mainly due to clinical and manufacturing costs linked to the Phase 2 trial for nimacimab, along with increased employee benefits, travel, and consulting fees driven by higher headcounts.
G&A Expenses: General and administrative expenses increased to $4.6 million from $2.2 million in Q3 2023, primarily due to non-cash incentive stock-based compensation, professional services, tax, audit, and legal fees for regulatory filings, financial advisory services, and patent prosecution for nimacimab IP. Litigation-related legal fees saw a period-over-period decrease.
Net Loss: The net loss for Q3 2024 was $3.9 million, with $1.9 million in non-cash share-based compensation expense, compared to $24.9 million in Q3 2023, which included $0.2 million in non-cash share-based compensation expense. The significant decrease was largely due to the $21.2 million expense for the acquisition of the nimacimab in-process research and development asset in Q3 2023. Additionally, Skye recognized $1 million in interest income and $4.6 million in income from the partial derecognition of liabilities and recovery of losses related to legal proceedings.

About Skye Bioscience:
Skye is dedicated to discovering novel therapeutic pathways for metabolic health through developing next-generation molecules that modulate G-protein-coupled receptors. The company's strategy focuses on utilizing biologic targets with significant human proof of mechanism to develop first-in-class therapeutics with clinical and commercial differentiation. Skye is currently conducting a Phase 2 clinical trial for nimacimab in obesity, which also examines the combination of nimacimab and a GLP-1R agonist (Wegovy®).