CervoMed Reports Third Quarter 2025 Financial Results and Provides Corporate Updates

Core Insights - CervoMed has aligned with the FDA on the design of a planned Phase 3 clinical trial for neflamapimod in patients with dementia with Lewy bodies (DLB), indicating progress in regulatory discussions and trial preparations [1][3] - The Phase 2b RewinD-LB trial results showed a 64% risk reduction in clinically significant worsening of DLB symptoms over 32 weeks, highlighting the drug's potential efficacy [2][3] - The company plans to initiate a global pivotal trial in the second half of 2026, with additional biomarker data from ongoing trials expected in 2026 [1][3] Clinical Development Updates - CervoMed reported that the 32-week treatment data from the RewinD-LB trial demonstrated a durable beneficial effect on clinical progression and significant reductions in plasma levels of a neurodegeneration biomarker [1][2] - The FDA's feedback on the trial design supports the proposed endpoints and patient enrichment strategy, which are crucial for a potential New Drug Application [3] - Initial biomarker data from a Phase 2a trial in frontotemporal dementia (FTD) and topline results from a recovery after stroke trial are anticipated in 2026 [1][3] Financial Performance - As of September 30, 2025, CervoMed had approximately $27.3 million in cash and equivalents, down from $38.9 million at the end of 2024, which is expected to fund operations into the third quarter of 2026 [5] - Grant revenue for the three months ended September 30, 2025, was approximately $0.3 million, a decrease from $1.9 million in the same period in 2024, attributed to the completion of the initial phase of the RewinD-LB trial [6] - Research and Development (R&D) expenses increased to approximately $6.0 million for the quarter, compared to $5.1 million in the same period in 2024, primarily due to higher personnel and consulting costs [7] Operational Highlights - CervoMed appointed Matthew Winton, Ph.D., as Chief Commercial and Business Officer and David Quigley to its Board of Directors in October 2025, indicating a strengthening of its leadership team [4] - The company’s lead drug candidate, neflamapimod, is designed to target neuroinflammation and neurodegeneration, with potential applications in DLB, recovery after ischemic stroke, and frontotemporal dementia [9][10]