CervoMed (CRVO) Corporate presentation summary

Strategic positioning and pipeline

• Advancing neflamapimod as a first-in-class oral therapy for dementia with Lewy bodies (DLB), with robust clinical proof-of-concept and a well-defined safety profile.

• Pipeline includes additional programs in non-fluent variant primary progressive aphasia (nfvPPA), recovery after stroke (RAS), and amyotrophic lateral sclerosis (ALS), with key data readouts expected in 2026–2027.

• Engaged with FDA on Phase 3 trial design for DLB, targeting patients without Alzheimer’s disease (AD) co-pathology.

• High unmet need and large market opportunity in DLB without AD co-pathology, representing about half of all DLB cases.

• Experienced leadership and scientific advisory team with backgrounds in neurology, pharmaceuticals, and clinical development.

Clinical trial results and drug profile

• Phase 2b study showed neflamapimod DP Batch B achieved targeted plasma concentrations, resulting in significant and durable improvements in CDR-SB and reduction in plasma GFAP, a biomarker of neurodegeneration.

• DP Batch B demonstrated a 117% reduction in mean change in CDR-SB, 75% reduction in risk of clinical progression, and 50% reduction in GFAP compared to placebo.

• Clinical effects were durable out to 32 weeks, with a 65% reduction in CDR-SB change and a hazard ratio of 0.46 for progression-free survival.

• PK/PD analysis established a Ctrough threshold of 4 ng/mL for clinical activity, with planned Phase 3 dosing (50mg TID) expected to achieve this in 80–90% of participants.

• New stable crystal form of neflamapimod supports consistent plasma exposure for future trials.

Market and regulatory outlook

• DLB without AD co-pathology is a substantial, untapped specialty market with high commercial potential in the US, EU, and Japan.

• No approved therapies currently target the underlying disease process in DLB.

• Planned Phase 3 trial will enroll approximately 300 patients at over 60 sites, using change in CDR-SB as the primary endpoint.

• Enrichment strategy using plasma pTau181 < 21 pg/mL validated to select patients without AD co-pathology, optimizing trial population.

• Strategic partnerships and/or additional funding are prerequisites for Phase 3 trial initiation.