CervoMed Reports Second Quarter 2025 Financial Results and Provides Corporate Updates

Core Insights - CervoMed Inc. reported significant findings from the Phase 2b RewinD-LB trial, indicating that neflamapimod treatment led to a 54% risk reduction in clinically significant worsening of Dementia with Lewy Bodies (DLB) at week 32 compared to the control group, with an improved 64% reduction among patients with minimal Alzheimer's disease co-pathology [1][3][9] - The company plans to engage with the U.S. Food and Drug Administration (FDA) in Q4 2025 to align on the design of the Phase 3 trial for DLB, with the trial expected to start in mid-2026, contingent on funding [1][3][5] Clinical Trial Results - The 32-week Extension phase of the Phase 2b RewinD-LB trial showed a statistically significant reduction in plasma levels of glial fibrillary acidic protein (GFAP) in patients treated with neflamapimod, with a mean change of -18.4±4.0 pg/mL for all participants and -21.2±4.4 pg/mL for those with ptau181 < 2.2 pg/mL [1][3][2] - The trial's primary endpoint was the Clinical Dementia Rating Sum of Boxes (CDR-SB), which demonstrated a significant reduction in clinical progression for patients receiving neflamapimod [3][9] Financial Overview - As of June 30, 2025, CervoMed had approximately $33.5 million in cash and cash equivalents, down from $38.9 million at the end of 2024, which is expected to fund operations into Q3 2026 [5][6] - Grant revenue for Q2 2025 was approximately $1.8 million, a decrease from $3.3 million in the same period in 2024, attributed to the transition from the initial double-blind phase to the Extension phase of the trial [6][8] - Research and Development (R&D) expenses increased to approximately $5.1 million in Q2 2025 from $3.8 million in Q2 2024, primarily due to rising costs associated with clinical trials and CMC activities [7][8] Corporate Developments - In June 2025, Marco Verwijs, PhD, joined CervoMed as Executive Vice President, Technical Operations, to oversee the Chemistry, Manufacturing, and Controls (CMC) division [3] - The company is also conducting Phase 2a trials of neflamapimod in patients recovering from acute stroke and in those with the nonfluent/agrammatic variant of primary progressive aphasia (PPA) [3][4]