Skye Bioscience, Inc. ((SKYE)) has held its Q2 earnings call. Read on for the main highlights of the call.
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Skye Bioscience’s recent earnings call conveyed a generally positive sentiment, highlighting significant strides in clinical development, a robust financial position, and strategic team growth. Despite challenges such as increased R&D expenses and a higher net loss, the company’s positive developments and strategic plans appear to outweigh these concerns.
Advanced Clinical Progress of Nimacimab
The Phase IIa CBeyond study for nimacimab is progressing as planned, both on budget and ahead of schedule. Enrollment was completed in February, and the 26-week visit for the last patient is anticipated soon. The study has undergone four reviews by the Data Safety Monitoring Committee, all without any recommendations for changes, underscoring its smooth advancement.
Nimacimab’s Potential in Obesity Treatment
Nimacimab has shown promising results in obesity treatment, demonstrating a 44% vehicle-adjusted weight loss when combined with a suboptimal dose of tirzepatide. This combination outperformed either agent alone, suggesting nimacimab’s potential as a maintenance therapy to sustain weight loss with improved tolerability.
Strong Financial Position
Skye Bioscience concluded the second quarter with $48.6 million in cash and cash equivalents, a financial cushion expected to support operations through at least the first quarter of 2027. This strong financial footing provides a solid foundation for ongoing and future projects.
Positive Preclinical Findings
In preclinical studies, nimacimab demonstrated superior durability of weight loss compared to incretin therapy, maintaining post-treatment weight for approximately 20 days. These findings further bolster its potential in therapeutic applications.
Strategic Team Expansion
The company has expanded its team to 20 employees, making strategic hires in regulatory affairs, quality, clinical operations, and CMC. This expansion is intended to support the advancement of development activities, ensuring the company is well-equipped to meet its ambitious goals.
Increased Research and Development Expenses
R&D expenses rose significantly to $14.3 million for the quarter, up from $4.1 million in the same period in 2024. This increase was primarily driven by contract manufacturing and clinical trial costs, reflecting the company’s commitment to advancing its clinical programs.
Net Loss Increase
Skye Bioscience reported a net loss of $17.6 million for the quarter, up from $7.9 million in the same period in 2024. While this increase is notable, it is aligned with the company’s expanded research and development activities.
Extension Study Enrollment Delays
Approximately 50% of patients from the original study are eligible for the extension study, with delays in planning and some early terminations impacting enrollment. Despite these challenges, the extension study is underway, contributing to the comprehensive evaluation of nimacimab.
Forward-Looking Guidance
Skye Bioscience provided detailed guidance during the call, emphasizing the advancement of the Phase IIa CBeyond study ahead of schedule and on budget. The company is on track to deliver top-line results by late Q3 or early Q4 2025. Financially, Skye maintains a cash flow guidance to fund operations through at least Q1 2027. Upcoming milestones include a KOL event on September 4, a presentation at EASD on September 19, and multiple investor conferences in the fall. The company aims to finalize the Phase IIb protocol and advance CMC activities following the top-line data readout.
In summary, Skye Bioscience’s earnings call highlighted a positive trajectory, with significant clinical progress and a strong financial position. Despite increased expenses and net loss, the company’s strategic plans and promising developments in nimacimab’s clinical trials suggest a bright future. Investors and stakeholders can look forward to upcoming milestones and continued advancements in the company’s pipeline.