Latest news with #Phase2A
Yahoo
08-08-2025
- Business
- Yahoo
Skye Bioscience Inc (SKYE) Q2 2025 Earnings Call Highlights: Promising Trial Progress Amid ...
Release Date: August 07, 2025 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. 擷取數據時發生錯誤 登入存取你的投資組合 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤
Time of India
18-05-2025
- Business
- Time of India
Terms unviable so pulled plug on Metro 3: Telecom operators
Mumbai: Amid rising commuter concerns over the sudden loss of mobile connectivity in Metro Line 3, telecom operators clarified that the disruption stemmed from unresolved commercial and operational issues with the Mumbai Metro Rail Corporation Ltd (MMRCL). In a statement issued by the Cellular Operators Association of India (COAI), the industry said it was fully committed to ensuring connectivity inside underground Metro stations but cited non-viable terms imposed by MMRCL and the exclusive involvement of a third-party vendor as key obstacles. COAI director general Lt Gen S P Kochhar said MMRCL's decision to route mobile services only through a neutral host provider, ACES, created a monopolistic setup, forcing telecom operators to operate under what they call "extortionate" conditions. "Mumbai Metro has denied direct Right of Way (RoW) to telecom service providers, which goes against provisions of the new Telecommunication Act and RoW rules," the association said. The operators added that services inside Metro 3 were being provided on a trial basis, pending final agreements. To avoid service disruption, they jointly proposed on April 7, to offer mobile coverage free of cost — without charging MMRCL or the third-party vendor — until commercial terms could be finalised. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like This game will kill your time! Only 3% can pass Level 8. Conquer the challenge now! Stormshot Play Now Undo This offer, they claim, went unanswered. Highlighting precedents from other major infrastructure sites — including the PWD tunnel at Pragati Maidan and the Central Vista project — COAI said TSPs deployed mobile infrastructure there without involving third-party intermediaries or facing similar commercial demands. The ongoing standoff affected all 16 operational underground stations on Metro Line 3, including Phase I (Aarey/JVLR to BKC) and the recently opened Phase 2A (BKC to Acharya Atre Chowk). Only Reliance Jio remains partially active, with service available at SEEPZ station. MMRCL earlier said that the necessary infrastructure was already installed to support telecom networks and expressed concern over the abrupt withdrawal of services by mobile operators. Vodafone resumed its services on May 17.
