CervoMed (CRVO) investor relations material

Clinical program overview

• Lead asset neflamapimod targets dementia with Lewy bodies (DLB) and is entering phase 3 trials next year, with FDA feedback expected this quarter.

• DLB is a fast-progressing neurodegenerative disease with no approved therapies, representing a large, untapped market, especially for pure DLB patients.

• Neflamapimod is designed to reverse synaptic dysfunction in cholinergic neurons, targeting the underlying neurodegeneration in DLB.

• Patient segmentation for trials is enabled by a simple blood test, focusing on pure DLB, which comprises about 50% of the DLB population.

• Additional clinical programs include phase 2 studies in stroke recovery and frontotemporal dementia, with orphan drug designation for the latter.

Clinical data and trial design

• Preclinical and phase 2 data show neflamapimod reverses cholinergic neuron loss, improves behavioral outcomes, and positively impacts key biomarkers.

• Phase 2b trial used a stringent p-tau 181 blood test cutoff to enrich for pure DLB patients, with the CDR-Sum of Boxes as the primary endpoint.

• Batch B of the drug, achieving target plasma levels, showed significant clinical benefit: up to 82% reduction in disease progression in optimal patients.

• Clinical improvements were supported by reductions in neurodegeneration biomarkers (GFAP) and favorable safety profile with minimal adverse events.

• Phase 3 will be a 24-week, placebo-controlled study in about 300 pure DLB patients, leveraging the fast progression of DLB for efficient trial design.

Regulatory and strategic outlook

• Ongoing FDA discussions focus on confirming trial length, patient numbers, and use of CDR-Sum of Boxes as the primary endpoint.

• All briefing materials and data have been submitted to the FDA, with public updates planned after feedback.

• The company holds fast-track designation for DLB and sees high unmet need and multi-billion dollar market potential.

• Drug aims to treat both newly diagnosed and existing pure DLB patients, potentially extending treatment duration by slowing disease progression.

• Leadership is highly experienced in neurology and neurodegeneration, with recent hires motivated by strong clinical data and market opportunity.