CervoMed Inc. (NASDAQ:CRVO) on Wednesday shared additional data from its Phase 2b RewinD-LB trial of neflamapimod for dementia with Lewy bodies (DLB).The results are based on the final analyses of the RewinD-LB trial, conducted after the August 2025 database lock for the full 48-week trial (16 weeks placebo-controlled (Initial Phase), followed by a 32-week neflamapimod-only extension (Extension Phase)).In the subset of participants whose plasma ptau181 levels were below 21 pg/mL at screening, results includ ...

Significant improvement relative to placebo on primary outcome measure, change in Clinical Dementia Rating Sum of Boxes (CDR-SB), demonstrated in a within-subject analysis in participants with low likelihood of having Alzheimer’s disease (AD) co-pathology Significant reduction in plasma levels of a well-established biomarker of neurodegeneration, plasma glial fibrillary acidic protein (GFAP), correlated to treatment response assessed by CDR-SB CervoMed anticipates U.S. Food and Drug Administration (FDA) fee ...

Expanding executive leadership team to prepare for late-stage development, strategic organizational growth, and market readinessBOSTON, Oct. 07, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced the appointment of Matthew Winton, Ph.D., as Chief Commercial and Business Officer. Dr. Winton joins CervoMed with nearly two decades of experience in the global biotechnolog ...

BOSTON, Oct. 02, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced that Company management will participate in a panel discussion and one-on-one meetings at the upcoming 4th Annual ROTH Healthcare Opportunities Conference being held in New York, NY, on Thursday, October 9, 2025. Panel DetailsTitle: “Small Firms Tackling Blockbuster Indications”Date: Thursday, October ...

Core Insights - CervoMed Inc. is advancing its clinical program for neflamapimod, targeting Dementia with Lewy Bodies (DLB), highlighted at the American Neurological Association conference [1][2] - The Phase 2b trial demonstrated a 74% risk reduction in clinically significant worsening of dementia symptoms compared to placebo in patients unlikely to have Alzheimer's disease co-pathology [2][4] - The company plans to initiate a Phase 3 trial in DLB patients, with alignment on trial design expected with the FDA in Q4 2025 [2] Company Overview - CervoMed is a clinical-stage company focused on treatments for age-related neurologic disorders, specifically developing neflamapimod, an investigational small molecule [5] - Neflamapimod targets synaptic dysfunction associated with neurodegenerative diseases, including DLB [5] Clinical Trial Details - The RewinD-LB Phase 2b trial was a randomized, double-blind, placebo-controlled study involving 159 DLB patients, assessing the efficacy of oral neflamapimod [4] - The trial was funded by a $21.3 million grant from the National Institutes of Health, with 43 sites across the U.S., U.K., and Netherlands [4] - The initial phase faced challenges in evaluating clinical activity due to issues with the drug formulation, but the Extension phase allowed for effective evaluation of the treatment [4]

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]

BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that Company management will participate in a fireside chat and one-on-one investor meetings at the CG 45 Annual Growth Conference being held in Boston, MA, on Tuesday, August 12 to Thursday, August 14, 2025. Investor Contact: PJ Kelleher LifeSci Advisors Investors@cervomed.com 617-430-7579 The webcast of the fireside chat wil ...

Core Insights - CervoMed Inc. presented 32-week data from the Extension phase of its Phase 2b RewinD-LB trial, focusing on oral neflamapimod for patients with Dementia with Lewy Bodies (DLB) [1][2] Group 1: Trial Results - The Extension phase demonstrated that neflamapimod continued to slow disease progression and positively affected a key plasma marker of neurodegeneration in DLB patients [2] - At Week 32, there was a statistically significant reduction in GFAP plasma levels in patients receiving New Capsules, with a mean change of -18.4±4.0 pg/mL for all participants (N=107) and -21.2±4.4 pg/mL for those with screening plasma ptau181 below 2.2 pg/mL (N=91) [4][5] - Placebo recipients in the initial phase showed a mean increase in GFAP levels of +1.1±3.0 pg/mL for all participants (N=74) and +1.1±3.3 pg/mL for the subset with screening plasma ptau181 below 2.2 pg/mL (N=65) [5] Group 2: Safety and Tolerability - Both Old and New Capsules exhibited comparable tolerability profiles, with no new safety signals identified during the Extension phase [5] - A lower incidence of falls was observed in participants with screening ptau181 < 2.2 pg/mL who received New Capsules compared to those receiving Old Capsules or placebo, with significant p-values indicating statistical relevance (p=0.025 vs. Old Capsules; p=0.007 vs. placebo) [5] Group 3: Market Reaction - Following the announcement of the trial results, CRVO stock increased by 29.4%, reaching $11.62 [6]

Group 1 - CervoMed Inc. (CRVO) shares increased by 11.6% to close at $8.98, with notable trading volume compared to typical sessions, and a 13.3% gain over the past four weeks [1][2] - The price rise is linked to growing investor optimism regarding the company's pipeline candidate, neflamapimod, aimed at treating Dementia with Lewy Bodies and other neurological disorders [2] - The company is expected to report a quarterly loss of $0.57 per share, reflecting a year-over-year change of -111.1%, with revenues projected at $1.11 million, down 66.3% from the previous year [2] Group 2 - The consensus EPS estimate for CervoMed has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] - CervoMed currently holds a Zacks Rank of 3 (Hold), while another company in the same industry, Qiagen, has a Zacks Rank of 2 (Buy) and closed 1.1% higher at $51.79 [5][6] - Qiagen's consensus EPS estimate for the upcoming report is $0.6, representing a +5.3% change from the previous year [6]

Summary of CervoMed Conference Call Company and Industry - **Company**: CervoMed - **Industry**: Neurology, specifically focusing on treatments for dementia with Lewy bodies (DLB) Core Points and Arguments 1. **Clinical Trial Results**: CervoMed announced 32-week data from the Phase 2b REWIND DLB trial, showing that neflamapimod has the potential to slow disease progression in DLB patients, building on previous 16-week results [3][15][23] 2. **Disease Overview**: DLB is a progressive brain disorder characterized by cognitive decline and movement problems, with no approved treatments in the US or EU, representing a significant unmet medical need [6][7][10] 3. **Mechanism of Action**: Neflamapimod targets the hyperactivation of P38 MAP kinase, which is linked to neuroinflammation and cognitive decline in DLB [10][11] 4. **Clinical Endpoint**: The primary endpoint for the REWIND LB trial is the CDR Sum of Boxes, with a clinically meaningful worsening defined as a 0.5 increase [13][19] 5. **Statistical Analysis**: A Kaplan Meier analysis showed a 54% reduction in the risk of clinical progression with new capsules compared to old capsules, with a 64% reduction in patients with low plasma pTau levels [19][20][23] 6. **Biomarker Data**: Plasma GFAP levels, a marker of neurodegeneration, decreased by approximately 18% in patients receiving new capsules, indicating a positive treatment effect [21][24] 7. **Regulatory Path**: CervoMed plans to meet with the FDA in 2025 to discuss the Phase III trial design, which is expected to be similar to the Phase IIb trial [26][29] Additional Important Information 1. **Patient Population**: The initial target population for neflamapimod is approximately 175,000 diagnosed patients with DLB, highlighting the market potential [9] 2. **Treatment Duration**: The Phase III trial is anticipated to last 24 weeks, compared to the 16-week duration of the Phase IIb trial [27] 3. **Market Potential**: The first disease-modifying therapy for DLB could have multibillion-dollar potential, given the high unmet need in this area [29] 4. **Compliance and Adherence**: Patient adherence to the treatment regimen has been reported as very good, with minimal missed doses [44] 5. **International Licensing**: CervoMed is open to regional licensing deals in Europe, Japan, or East Asia to maximize opportunities and potentially secure non-dilutive financing [48] This summary encapsulates the key points discussed during the CervoMed conference call, focusing on the company's advancements in treating DLB and the implications for future clinical trials and market opportunities.