Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026
Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen
Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive aphasia trial, and initiation of EXPERTS-ALS trial in Amyotrophic Lateral Sclerosis
BOSTON, March 17, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. $(CRVO)$, a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided corporate updates.
"CervoMed made significant strides in 2025 and early 2026 with its lead neflamapimod program in dementia with Lewy bodies $(DLB)$. We reported positive and supportive Phase 2b RewinD-LB data at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, obtained alignment with the U.S. Food and Drug Administration (FDA) and other global regulators on the design of our planned Phase 3 trial design in patients with DLB, and selected the neflamapimod formulation, dose and dosing regimen that will be used in the planned Phase 3 trial," said John Alam, MD, Chief Executive Officer of CervoMed. "We are now looking ahead to a catalyst-driven 2026, including initiation of the planned Phase 3 trial evaluating neflamapimod in DLB in the second half of 2026, subject to available financing. In addition, we expect to report initial topline Phase 2a results from our other programs evaluating neflamapimod in both ischemic stroke recovery (RAS) and the non-fluent variant primary progressive aphasia (nfvPPA), along with initiation of the EXPERTS-ALS trial in amyotrophic lateral sclerosis (ALS), all during the second half of 2026 as well."
Fourth Quarter 2025 and Recent Program Highlights
Dementia with Lewy Bodies
-- CervoMed selected 50mg three times per day (TID) of a stable crystal form
of neflamapimod produced using a new, controlled manufacturing process as
the dose and dosing regimen that will be used for the Company's planned
Phase 3 trial in patients with DLB.
-- CervoMed obtained alignment with the FDA on a proposed Phase 3 trial
design to support a potential New Drug Application for neflamapimod in
DLB in November 2025 and with other global regulators during the first
quarter of 2026. Based on FDA feedback, CervoMed plans to initiate a
single, global, randomized, double-blind, placebo-controlled Phase 3
clinical trial evaluating the efficacy and safety of neflamapimod in
approximately 300 patients with DLB, subject to available funding. The
trial will exclude patients who have historical evidence of AD
co-pathology by brain imaging scan or cerebrospinal fluid sampling and
will be further enriched for participants who do not have AD co-pathology
by excluding patients with plasma ptau181 >= 21.0 pg/mL at screening.
Participants will be randomized 1:1 to receive either oral neflamapimod
or placebo for 32 weeks, followed by a neflamapimod only extension for 48
weeks. The primary endpoint will be worsening of global cognition and
function as measured by change in the Clinical Dementia Rating-Sum of
Boxes (CDR-SB). Secondary endpoints include the percentage of
participants who have a greater than 1.5-point increase in CDR-SB and
other well-established measures of cognitive and motor function.
Assessments of key biomarkers of the neurodegenerative process will also
be included.
-- In a late-breaking oral session at CTAD Conference, clinical
investigators shared the full results of the Phase 2b RewinD-LB trial
evaluating neflamapimod for the treatment of DLB. The results of the
trial demonstrated a significant and clinically meaningful effect on
multiple outcomes in DLB patients, including on the primary outcome
measure, change in CDR-SB, in the participants who received neflamapimod
drug product that achieved expected and targeted plasma drug
concentrations. These positive clinical outcomes were correlated with
observed reductions in established biomarkers of neurodegeneration,
supporting neflamapimod's mode of action targeting the underlying DLB
mechanism.
Amyotrophic Lateral Sclerosis (ALS)
-- Neflamapimod was recently selected for inclusion in the EXPERTS-ALS
platform in the United Kingdom (UK). EXPERTS-ALS facilitates rapid
testing of potential treatments for ALS to identify promising drug
candidates and potentially accelerate their path to regulatory approval.
EXPERTS-ALS, funded by the UK government and UK-based charities, will
conduct the clinical trial and CervoMed will provide drug product.
Corporate Updates
-- During the fourth quarter of 2025 and first quarter of 2026, multiple
patents related to neflamapimod were issued in Europe, Japan, and China,
strengthening CervoMed's global intellectual property portfolio
supporting the development of neflamapimod for neurodegenerative
disorders.
-- In October 2025, Matthew Winton, Ph.D., joined CervoMed as Chief
Commercial and Business Officer and David Quigley joined the Company's
Board of Directors.
Anticipated Milestones for 2026
-- DLB: CervoMed plans to initiate a Phase 3 trial evaluating neflamapimod
in patients with DLB in the second half of 2026, subject to obtaining
sufficient funding. The Company will present additional data supporting
its choice of patient population and dosing regimen for the trial at the
AD/PD 2026 Scientific Conference taking place March 17-21, 2026, in
Copenhagen, Denmark.
-- RAS: CervoMed expects to complete enrollment in its ongoing Phase 2a
RESTORE trial evaluating neflamapimod in patients recovering from acute
ischemic stroke in mid-2026 and to report topline data from the trial in
the second half of 2026.
-- nfvPPA: CervoMed expects to complete enrollment in its ongoing Phase 2a
trial evaluating neflamapimod in patients with nfvPPA in mid-2026. The
Company also expects to report initial biomarker data from the trial in
mid-2026 and initial topline clinical data from the trial in the second
half of 2026.
-- ALS: CervoMed expects initiation of the EXPERTS-ALS trial evaluating
neflamapimod in patients with ALS by the end of 2026.
Full Year 2025 Financial Results
Cash Position: As of December 31, 2025, CervoMed had approximately $20.9 million in cash, cash equivalents and marketable securities, as compared to $38.9 million as of December 31, 2024. Based on its current operating plan, CervoMed believes its cash, cash equivalents, and marketable securities on hand as of December 31, 2025, will enable the Company to fund its planned operating expenses and capital expenditure for approximately six months from the date of this release.
Grant Revenue: Grant revenue was approximately $4.0 million for the twelve months ended December 31, 2025, compared to approximately $9.7 million for the same period in 2024. The decrease in grant revenue was due to the completion of the randomized phase of the RewinD-LB Trial in late 2024, followed by the subsequent completion of the extension phase in mid-2025.
Research and Development (R&D) Expenses: R&D expenses for the twelve months ended December 31, 2025, were approximately $21.8 million, compared to approximately $18.8 million for the same period in 2024. The increase in R&D expenses was primarily due to increases in personnel and consulting costs, R&D- and CMC-related activities related to the batch issues identified during the RewinD-LB trial, implementation of the Company's pre-Phase 3 manufacturing improvements, and non-DLB clinical work for neflamapimod, including costs related to the RAS and nfvPPA clinical trials, which were both initiated during 2025.
General and Administrative (G&A) Expenses: G&A expenses were approximately $10.5 million during the twelve months ended December 31, 2025, compared to approximately $9.2 million for the same period in 2024. The increase in G&A expenses was primarily due to increases in personnel costs, insurance and taxes, and professional fees, partially offset by a decrease in stock-based compensation.
Net Loss: Net loss was approximately $27.0 million for the twelve months ended December 31, 2025, compared to approximately $16.2 million for the same period in 2024.
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 primary progressive aphasia.
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