CervoMed (CRVO) 7th Annual HCW Neuro Perspectives Hybrid Conference summary

Company Overview and Strategic Direction

• Developing neflamapimod, an oral drug targeting neurodegenerative disorders, with a focus on dementia with Lewy bodies (DLB); positive phase IIa and IIb data support advancement to phase III, pending financing.

• Recently closed a $10.5 million private placement, extending cash runway into Q2 2027 and enabling continued clinical development and partnership pursuits.

• Strategic partnership is prioritized to fund phase III in DLB and potentially other indications, aiming to minimize dilution and maximize shareholder value.

• All regulatory requirements for phase III initiation are met, including CMC, non-clinical, and toxicology studies, with a new 50 mg dose formulation ready.

• The management and board comprise experienced industry leaders with backgrounds in neurology, pharmaceuticals, and clinical development.

Clinical Development and Pipeline Progress

• Phase III trial in DLB is designed as a single, 300-patient study with CDR Sum of Boxes as the primary endpoint, agreed upon by FDA, EMA, and MHRA.

• The trial targets pure DLB patients, using a blood test to exclude Alzheimer’s co-pathology, enhancing outcome quality and pricing leverage.

• Additional clinical catalysts include a biomarker and clinical endpoint readout in non-fluent primary progressive aphasia (PPA), with robust enrollment nearing completion.

• ALS study initiation is planned by year-end, leveraging the same dosing regimen as DLB phase III, based on mechanistic rationale and recent publications.

• Data presentations are anticipated at major neurology meetings in the fall, potentially providing early biomarker results from the PPA study.

Key Clinical Findings and Drug Development Progress

• Neflamapimod demonstrated proof-of-concept efficacy in DLB patients, with significant reductions in clinical progression and neurodegeneration biomarkers compared to placebo.

• Statistically significant improvements in CDR-SB and ADCS-CGIC were observed with DP Batch B, with effects durable out to 32 weeks.

• Targeted plasma drug concentrations were achieved with DP Batch B, supporting the planned Phase 3 dosing strategy.

• Lowering plasma pTau181 cut-off enriches for DLB patients without AD co-pathology, optimizing patient selection for future trials.

• Engagement with the FDA on Phase 3 trial design and ongoing activities to improve drug formulation and secure partnerships.