CervoMed (CRVO) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Executive overview

• Focus on developing neflamapimod as a targeted therapy for dementia with Lewy bodies (DLB), with additional programs in primary progressive aphasia (PPA) and ALS.

• Positive phase II data in DLB and a clear phase III registration path agreed with FDA and global regulators.

• Expansion into new indications, including non-fluent PPA and ALS, with near-term data readouts and trial initiations.

• High unmet need in DLB, with no approved therapies and significant commercial opportunity in the U.S., Europe, and Japan.

• Strategic partnership and/or financing for phase III are key value-creating events in the next 12–18 months.

Disease and market insights

• DLB is characterized by cognitive decline, executive dysfunction, and unique symptoms like hallucinations and sleep disorders.

• Pure DLB patients, identified via blood-based pTau181 testing, represent about half of diagnosed cases and have less neurodegeneration than those with AD co-pathology.

• U.S. market size for pure DLB is estimated at 150,000–175,000 diagnosed patients, with similar or higher prevalence in Europe and Japan.

• No current therapies exist, creating strong pricing leverage and demand for targeted treatments.

Clinical development and data

• Neflamapimod inhibits p38α, targeting neuroinflammation and alpha-synuclein pathology central to DLB.

• Phase II-A showed significant slowing of clinical progression; phase II-B confirmed dose-dependent effects when adequate drug levels were achieved.

• Biomarker data (GFAP) and MRI results support clinical efficacy and disease modification.

• Phase III will enroll 300 patients, using CDR Sum of Boxes as the primary endpoint, with high statistical power and regulatory alignment.