Skye Bioscience Q2 2024 Financial Results and Highlights

Advancement of clinical and regulatory steps enable the expected initiation of Phase 2 obesity clinical trial for nimacimab peripheral CB1 inhibitor in Q3 2024

SAN DIEGO, Aug. 09, 2024 - Skye Bioscience, Inc. (NASDAQ: SKYE), a clinical-stage biopharmaceutical company dedicated to novel treatments for metabolic health, has released its second-quarter financial results for the period ending June 30, 2024, along with recent corporate milestones.

According to CEO Punit Dhillon, the acquisition of nimacimab in August 2023 has significantly bolstered Skye's presence in the metabolic health sector. The second quarter saw the unveiling of their CBeyond™ Phase 2 clinical trial design for nimacimab during the "Metabolic Rewiring with CB1 Inhibition" event. The company has also enhanced its metabolic focus by appointing new experts to its Board of Directors and establishing a clinical and scientific advisory board. Dhillon emphasized that Skye's NASDAQ uplisting and solid cash reserves lay a strong foundation for the forthcoming Phase 2 obesity clinical trial.

Key Corporate and Clinical Program Highlights

Phase 2 Obesity Trial Scheduled for Q3 2024

Nimacimab, a pioneering humanized monoclonal antibody, functions as a negative allosteric modulator to inhibit CB1 signaling peripherally. Skye disclosed its CBeyond™ Phase 2 clinical trial design for nimacimab aiming to treat obesity. This 120-participant trial is set to begin screening in the third quarter of 2024, with interim and final results expected in the second and fourth quarters of 2025, respectively. The trial's primary goal is to measure weight loss using nimacimab versus a placebo. Secondary objectives include assessing safety and tolerability, neuropsychiatric and cognitive impacts, changes in body composition via DEXA scans, and shifts in key metabolic biomarkers like triglycerides, insulin, and leptin sensitivity.

The trial will also explore the combination of nimacimab with a GLP-1 agonist, Wegovy®, evaluating differences in weight loss, body composition, and sleep quality. To complement the CBeyond™ trial, Skye has partnered with Beacon Biosignals. Since obesity can adversely affect sleep quality, Beacon Biosignals' FDA-cleared Dreem Headband will be used to collect and analyze sleep data in 40 trial participants as an exploratory endpoint.

Completion of Glaucoma Study

Skye has concluded a Phase 2a double-masked, randomized, placebo-controlled trial of SBI-100 Ophthalmic Emulsion (SBI-100 OE) in 56 patients with primary open-angle glaucoma or ocular hypertension. The primary goal was to measure diurnal intraocular pressure (IOP) changes. The study did not demonstrate a statistically significant IOP reduction over the placebo. Consequently, Skye has ceased all clinical and R&D activities related to SBI-100 OE, redirecting resources to its metabolic program.

Corporate Developments

Skye has recently appointed Karen Smith, MD, Ph.D., MBA, LLM, to its Board of Directors. Dr. Smith brings extensive global biotech and biopharma leadership experience, including over a decade of board and advisory roles. Additionally, Skye has formed a new Clinical and Scientific Advisory Board to guide nimacimab development. Advisors include Lee Kaplan, MD, Ph.D., Louis Aronne, MD, Rekha Kumar, MD, M.S., Marcus DaSilva Goncalves, MD, Ph.D., Beverly Tchang, MD, Eduardo Muñoz, MD, Ph.D., and Giovanni Appendino, Ph.D.

The company has successfully transitioned to the NASDAQ Global Market® from the OTCQB and has been added to the Russell 2000® and Russell 3000® indexes as of July 1, 2024. In August, Skye's convertible debt of $5 million was converted into 968,973 shares of common stock.

Second Quarter 2024 Financial Summary

Cash and cash equivalents stood at $74.1 million as of June 30, 2024, excluding $9.1 million in restricted cash. The company estimates its current funds will support operations until at least the first half of 2027. Skye's research and development expenses for Q2 2024 were $4.1 million, up from $1.8 million in Q2 2023, primarily due to costs related to the concluded glaucoma trial and preparations for the obesity Phase 2 trial. General and administrative expenses increased to $4.3 million from $1.2 million in the same period, driven by stock-based compensation, professional fees, and costs associated with NASDAQ uplisting. The net loss for Q2 2024 amounted to $7.9 million, compared to $3.1 million in Q2 2023.