Company: CRVO
Filing Date: 2025-05-12
Form Type: 424B5
Source: 0001437749-25-016167
Chunk: 6

Company: CervoMed Inc.
Filing Date: 2025-05-12
Form: 424B5
Chunk 6
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 Boxes test (p<0.001 vs. a batch of neflamapimod drug product capsules manufactured in October 2020 and administered for the initial phase of the RewinD-LB Trial, from which topline results were reported in December 2024 (the “Initial Phase”), and a portion of the Extension (the “Old Capsules”); p=0.003 vs. placebo), and the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, a secondary outcome measure in the trial (p=0.035 vs. Old Capsules; p=0.035 vs. placebo). We believe these results demonstrate proof-of-concept for neflamapimod as a potential treatment for DLB, and support our hypothesis that the failure of neflamapimod during the Initial Phase was the result of the Old Capsules delivering lower than expected drug concentrations and effectively underdosing participants. Additional data from the Extension were presented at the 19th International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurologic Disorders in April 2025, including that neflamapimod demonstrated improvements on endpoints measuring cognitive fluctuations and working memory. We expect to report 32-week results from the Extension in the second half of 2025 and we intend to meet with the U.S. Food and Drug Administration (the “FDA”) to discuss our Phase 3 plans following the availability of those data.

In addition to neflamapimod’s potential to treat DLB, we believe the benefit of targeting neuroinflammation-induced synaptic dysfunction in the BFC system can be applied to other neurologic indications in which treatment of BFC dysfunction and degeneration would be expected to be clinically beneficial, including as treatment for certain forms of frontotemporal dementia (“FTD”), for which the FDA granted neflamapimod Orphan Drug designation in November 2024, and promoting recovery after ischemic stroke. Based upon this potential, we initiated a Phase 2 trial evaluating neflamapimod in up to 90 participants recovering from ischemic stroke in the second quarter of 2025, and we intend to initiate a Phase 2a trial evaluating neflamapimod in up to 20 participants with the nonfluent/agrammatic variant of primary progressive aphasia, a subtype of FTD, in mid-2025.

Additional Information

For additional information related to our business and operations, please refer to the reports incorporated herein by reference, as described under the caption “Incorpor