Skye Bioscience Earnings Call: Mixed Signals with Promising Results

Skye Bioscience, Inc. ((SKYE)) has held its Q3 earnings call. Read on for the main highlights of the call.

The recent earnings call from Skye Bioscience, Inc. painted a mixed picture for investors and stakeholders. While the company demonstrated strong financial health and promising results from their Phase 2a study, challenges such as increased R&D expenses and concerns about monotherapy efficacy were also highlighted. The sentiment was cautiously optimistic, with a focus on the potential of Nimazumab in combination therapies.

Strong Financial Position

Skye Bioscience ended the third quarter with a robust financial standing, boasting cash and cash equivalents totaling $35.3 million. This financial cushion is expected to support the company’s operations and key clinical milestones well into 2027, providing a solid foundation for future endeavors.

Successful Phase 2a Study Results

The Phase 2a CBEYOND study yielded encouraging results, showcasing the synergistic efficacy of Nimazumab when combined with semaglutide. The combination achieved approximately 3% additional weight loss at 26 weeks, with a statistically significant p-value of 0.0372, marking nearly a 30% improvement over semaglutide alone.

Positive Safety Profile

Nimazumab demonstrated a favorable safety profile, with no neuropsychiatric signals or additional gastrointestinal burden reported. This positive safety signal is crucial for the ongoing development and potential approval of the drug.

Durability of Weight Loss

In a 12-week post-treatment follow-up, the combination of Nimazumab and semaglutide showed significantly less weight regain compared to semaglutide alone, with only 18% weight regain versus 50%, and a p-value of 0.006. This durability of weight loss is a promising aspect for long-term treatment efficacy.

Encouraging KOL Feedback

Feedback from key opinion leaders has been positive, particularly regarding the potential for dosing holidays without significant weight regain. This feedback underscores the potential flexibility and appeal of the combination therapy.

Increased R&D Expenses

R&D expenses saw a significant increase, rising to $9.4 million in Q3 2025 from $4.9 million in Q3 2024. This increase is primarily attributed to contract manufacturing and clinical trial costs, reflecting the company’s commitment to advancing its clinical programs.

Net Loss Increase

The company reported a net loss of $12.8 million for Q3 2025, a notable increase from $3.9 million in Q3 2024. This increase is partly due to non-cash share-based compensation expenses, highlighting the financial challenges accompanying their ambitious R&D efforts.

Monotherapy Efficacy Concerns

Concerns were raised regarding the efficacy of Nimazumab as a monotherapy. The Phase 2a study indicated that patients were underdosed at 200 mg, suggesting that higher doses are necessary to achieve the desired efficacy in monotherapy settings.

Limited Patient Enrollment in Extension Study

The extension study faced challenges with limited patient enrollment, with only 43 patients participating. This raises concerns about the ability to draw statistically significant insights from the study, potentially impacting the robustness of the findings.

Forward-Looking Guidance

Looking ahead, Skye Bioscience provided detailed guidance on its financial and clinical development milestones. The company plans to continue advancing its clinical trials, particularly focusing on Nimazumab’s dose concentration strategy and evaluating higher doses in future studies. With a strong cash position, the company is well-positioned to pursue these goals while maintaining scalability and patient convenience as priorities.

In summary, Skye Bioscience’s earnings call reflected a cautiously optimistic outlook. While the company faces challenges such as increased expenses and efficacy concerns, its strong financial position and promising clinical results provide a solid foundation for future growth. Investors and stakeholders will be keenly watching how the company navigates these challenges and capitalizes on its opportunities.