CervoMed to Share New Data on Neflamapimod as a Treatment for Dementia with Lewy Bodies at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference

Late-breaking oral presentation by a leading global authority in Dementia with Lewy bodies (DLB) to highlight updated data from Phase 2b study on neflamapimod treatment for DLB

New data demonstrating the utility of neflamapimod and its effects on key neurodegeneration biomarkers in DLB will also be highlighted in poster session

BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that neflamapimod, an oral, small molecule, targeting critical disease processes underlying degenerative disorders of the brain, will be featured in two presentations at the 18 th Clinical Trials on Alzheimer's Disease (CTAD) Conference taking place December 1-4, 2025, in San Diego, California.

In a late-breaking oral session by John-Paul Taylor, MBBS(hons) MRCPsych PhD, Professor of Translational Dementia Research at Newcastle University, United Kingdom (UK) and Chief Investigator of the RewinD-LB study for the UK, the full results of the Phase 2b RewinD-LB trial, including new data on the effects of neflamapimod treatment at 32 weeks, will be presented.

In addition, a poster presentation will highlight important findings from the RewinD-LB study regarding the utility of, and the treatment effects of neflamapimod on widely used neurodegeneration biomarkers in the trial, including plasma glial fibrillary acidic protein (GFAP), plasma neurofilament light chain (NfL), and beta amyloid 42/40 ratio. The plasma samples in the RewinD-LB study were analyzed by the Neurochemistry Laboratory at the Amsterdam University Medical Center (location Vrije Universiteit) under the supervision of Professor Charlotte Teunissen, PhD.

DLB is the second most common progressive dementia after Alzheimer’s disease (AD), affecting millions worldwide, and has no approved treatments. DLB progresses more rapidly than AD, with average time from diagnosis to requiring nursing home care being two years.

Neflamapimod Scientific Sessions

Late-Breaking Oral Session

Title: Results of the Phase 2b Trial of Neflamapimod in Dementia with Lewy Bodies Session: LB31 Presenter: John-Paul Taylor Authors: John-Paul Taylor, Stephen N Gomperts, Lawrence S Honig, Niels D Prins, Amanda Gardner, Kelly Blackburn, John Alam, James E Galvin Date/Time: Thursday, December 4, 2:10 p.m. PT

Poster presentation

Title: Neflamapimod Significantly Lowers Plasma GFAP and Correlates with Clinical Benefit in Dementia with Lewy Bodies (DLB): Results from the RewinD-LB Trial Session: Poster 071 Authors: John Alam, Hui-May Chu, Amanda Gardner, Kelly Blackburn, Charlotte E Teunissen Date/Time: Monday, December 1 starting at 3:00 p.m. PT through Tuesday, December 2 at 5:30 p.m. PT

About the RewinD-LB Phase 2b Trial in Dementia with Lewy Bodies The initial phase of RewinD-LB was a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in 159 participants with DLB, followed by a 32-week neflamapimod-only treatment extension phase. Patients with AD co-pathology, as assessed by plasma ptau181 levels, were excluded from the trial. The primary endpoint in the trial is change in the CDR-SB, and secondary endpoints include the ADCS-CGIC, the Timed Up and Go test, and a cognitive test battery.

The RewinD-LB trial was funded primarily by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging, disbursed over the course of the trial as costs were incurred. The trial included 43 sites across in the United States, the United Kingdom, and the Netherlands.

About Dementia with Lewy Bodies DLB is the second most common progressive dementia after Alzheimer’s disease, affecting millions worldwide. Patients may experience a combination of decline in cognitive function, cognitive fluctuations, visual hallucinations, and sleep disorders, as well as motor symptoms similar to Parkinson’s disease. There are no approved treatments for DLB in the United States or European Union, and the current standard-of-care therapies only temporarily relieve symptoms.

About CervoMed CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral, small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in DLB patients who have a low likelihood of AD co-pathology, and the Company plans to initiate a global, pivotal Phase 3 trial in the same patient population in the second half of 2026.

About Neflamapimod Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood–brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and frontotemporal dementia.

In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients with “pure” DLB, those without AD co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders.

Forward-Looking Statements

This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the therapeutic potential of neflamapimod, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s announcement of additional data or any meeting or correspondence between the Company and the FDA or other regulatory bodies; any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the RewinD-LB trial will be replicated in later trials, including the Company’s planned Phase 3 clinical trial evaluating the efficacy and safety of neflamapimod in patients with DLB; the timing of the initiation of and the design and endpoints of, any potential future trials, including the Company’s planned Phase 3 clinical trial evaluating the efficacy and safety of neflamapimod in patients with DLB; the Company’s need to acquire sufficient funding for any Phase 3 trial of neflamapimod in DLB; expectations with respect to neflamapimod, including the timing of any regulatory submissions and potential approvals thereof, if any; the timing of the Company’s potential submission of an NDA, if any; and the potential market for any DLB treatment that may be approved in the future. . Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

Contacts

Media: Biongage Communications [email protected] 202-330-3431

Investor Relations: LifeSci Advisors PJ Kelleher Investors@cervomed.com 617-430-7579