CervoMed (CRVO) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Company overview and lead asset

• Focuses on CNS therapeutics with lead oral drug neflamapimod targeting dementia with Lewy bodies (DLB), the third most common age-related brain disease.

• Neflamapimod is the only drug with positive phase II clinical activity in DLB and is currently in phase IIb studies.

• The drug inhibits p38 alpha MAP kinase, reducing neuroinflammation and improving synaptic function in the basal forebrain's cholinergic neurons.

• Animal models show neflamapimod fully reverses disease processes in the targeted brain region.

Disease context and market opportunity

• DLB affects 700,000 patients in the U.S., with a distinct clinical profile and faster progression than Alzheimer's disease.

• Early and mid-stage DLB patients experience worse quality of life and faster decline, but less neuronal loss than Alzheimer's, offering greater drug impact potential.

• No approved therapies exist for DLB; current treatments are only symptomatic and not disease-modifying.

• Early-stage DLB, defined by less neuronal loss, represents about half of DLB patients and is now identifiable via blood tests like p-tau181.

Clinical development and biomarker strategy

• Phase IIa and IIb trials focus on early-stage DLB, leveraging p-tau181 to exclude advanced cases and maximize treatment effect.

• Neflamapimod showed early separation from placebo on cognitive and functional endpoints, with effects visible as soon as four weeks.

• GFAP biomarker analysis revealed significant reductions in treated patients, correlating with clinical improvement and suggesting reversal of neurodegeneration.

• All biomarker and clinical data support the hypothesis that neflamapimod modifies disease in early DLB.