Skye Bioscience Inc (SKYE) Q2 2025 Earnings Call Highlights: Promising Trial Progress Amid ...
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Skye Bioscience Inc (NASDAQ:SKYE) completed enrollment for its Phase 2A CBon trial ahead of schedule, with the 26-week visit for the last patient projected to occur soon.
The Data Safety Monitoring Committee has reviewed the study four times without recommending any changes, indicating a well-managed program.
Nemasimab, the company's CB1 antibody, shows negligible brain penetration, potentially reducing central toxicity and offering a broader therapeutic window.
Pre-clinical studies suggest Nemasimab can enhance the efficacy of sub-optimal doses of other treatments, offering potential for combination strategies.
Skye Bioscience Inc (NASDAQ:SKYE) ended the second quarter with $48.6 million in cash and equivalents, projected to fund operations through at least Q1 2027.
Negative Points
Research and development expenses increased significantly to $14.3 million in Q2 2025 from $4.1 million in the same period in 2024.
The net loss for Q2 2025 was $17.6 million, more than double the $7.9 million loss in Q2 2024.
Approximately 50% of patients from the original study are eligible for the extension study, potentially limiting the data set for long-term analysis.
The company faces a competitive landscape with high discontinuation rates for existing obesity treatments, which could impact market penetration.
The follow-up data for the extension study, including durability of weight loss, will not be available until the first half of 2026, delaying comprehensive results.
Q & A Highlights
Warning! GuruFocus has detected 4 Warning Signs with BOM:500114.
Q: Can you explain the increase in R&D expenses and the role of Arecor in the development of Nemasimab? A: (CEO) The increase in R&D expenses, which reached $14 million in Q2, was largely due to contract manufacturing costs for the phase 2A resupply and phase 2B trial preparations. Arecor is assisting in increasing the concentration of Nemasimab to potentially allow for less frequent dosing, which is part of our lifecycle management strategy and does not interfere with our current clinical development.
Q: What are your expectations for Nemasimab's weight loss efficacy in the phase 2A trial, and what other metrics are important? A: (CEO) We aim to demonstrate a clinically meaningful weight loss of 5-8% placebo-adjusted difference over 26 weeks. The study is designed to validate the mechanism, establish safety and tolerability, and set the stage for a phase 2B dose-ranging study. Key metrics include consistent weight loss, improved GI tolerability, and a strong safety profile without neuropsychiatric side effects.
Q: What are your expectations for patient discontinuation rates, and how does this compare to GLP-1 therapies? A: (CEO) We expect discontinuation rates similar to other obesity studies, around 25-30%. In the real world, GLP-1 therapies see about 50% discontinuation after one year. Nemasimab aims to capture patients who discontinue GLP-1 therapies by providing long-term sustainable weight loss without the GI side effects.
Q: How does the extension study enrollment work, and why is only 50% of the original study's patients eligible? A: (Chief Medical Officer) Patients who complete 26 weeks of dosing are eligible for the extension study. The 50% eligibility is due to the extension study being designed after the original study started, leading to some patients completing the study before the extension was available.
Q: What is the protocol for the independent board overseeing trial safety, and what types of adverse events do they report? A: (Chief Medical Officer) The Data Monitoring Committee meets quarterly and reviews all safety data, including adverse events and serious adverse events. They have access to unblinded information and can request clarifications or additional monitoring if needed. So far, they have not recommended any changes to the study.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
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