Company: CRVO
Filing Date: 2025-05-12
Form Type: 424B5
Source: 0001437749-25-016167
Chunk: 5

Company: CervoMed Inc.
Filing Date: 2025-05-12
Form: 424B5
Chunk 5
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 drug candidate of which we are aware that has shown statistically significant improvements compared to placebo in a Phase 2a clinical trial (our “AscenD-LB Trial”) and improved outcomes (p < 0.001) on the trial’s primary endpoint in a Phase 2b evaluation (16-week extension data from our ongoing RewinD-LB Trial). We are also the only company of which we are aware that is specifically targeting the treatment of DLB patients without Alzheimer’s disease (“AD”) co-pathology. Compared to patients with “pure” DLB – who may represent up to 50% of the total diagnosed DLB patient population at any given time – DLB patients with AD co-pathology have significant, irreversible neuronal loss in the hippocampus, which may be assessed via imaging or biomarker evidence of amyloid and/or tau pathology. DLB without AD co-pathology, however, is primarily a disease of reversible synaptic dysfunction in the basal forebrain cholinergic (“BFC”) system and, based on available preclinical and clinical data, we believe if neflamapimod is given in the early stages of certain degenerative diseases of the brain, it may reverse synaptic dysfunction, improve neuron health and function, and slow further progression by delaying synaptic dysfunction and neuronal death. We believe that targeting DLB patients without AD co-pathology enhances the alignment of our development path with neflamapimod’s mechanism of action, reduces the heterogeneity of our target patient population, and thereby has the potential to improve outcomes for patients.

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Our ongoing RewinD-LB Trial is a Phase 2b trial in 159 participants with DLB funded primarily by a $21.3 million grant from the NIA. Patients with AD co-pathology, as assessed by plasma phosphorylated tau at position 181 levels at screening, were excluded from the trial. Intended to confirm the efficacy findings from the AscenD-LB Trial, we announced 16-week results from the 32-week open-label extension phase (the “Extension”) of the RewinD-LB Trial in March 2025. In the first 16 weeks of the Extension, treatment with a batch of neflamapimod drug product capsules manufactured in March 2023 and administered for the majority of the RewinD-LB Trial Extension phase led to increased plasma drug concentrations and demonstrated improvement on the trial’s primary outcome measure, change from baseline in the Clinical Dementia Rating Sum of the