CervoMed (CRVO) H.C. Wainwright 27th Annual Global Investment Conference summary

Clinical focus and patient population

• Targeting pure dementia with Lewy bodies (DLB) patients without Alzheimer's disease (AD) pathology, using a blood test as a surrogate for PET scans.

• Estimated 175,000 diagnosed pure DLB patients in the U.S., representing a high unmet medical need with no approved therapies.

• Current symptomatic therapies do not address the underlying disease, highlighting a significant commercial opportunity.

Drug mechanism and scientific rationale

• The drug inhibits p38 alpha MAP kinase, linking alpha-synuclein pathology and neuroinflammation to cholinergic neuron loss.

• Alpha-synuclein triggers disease pathogenesis, leading to synaptic dysfunction and loss of acetylcholine-producing neurons.

• Preclinical studies show full reversal of cholinergic deficits; findings published in major scientific journals.

Clinical trial results and interpretation

• Phase 2a and 2b studies demonstrated efficacy in cognition, dementia severity, and motor function, especially in patients without AD co-pathology.

• Initial phase 2b results were confounded by a manufacturing issue with drug capsules, leading to subtherapeutic dosing.

• Extension study with corrected dosing showed significant improvement in clinical progression and multiple endpoints.

• Kaplan-Meier analysis revealed a 65–74% reduction in risk of progression for the target population at therapeutic drug levels.

• Biomarker data supported clinical findings, showing a profound reduction in disease progression markers.