CervoMed (CRVO) investor relations material

Clinical focus and patient population

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

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

• DLB is managed by neurologists and presents a substantial commercial opportunity due to the lack of disease-modifying treatments.

Scientific rationale and drug mechanism

• The drug inhibits p38 alpha MAP kinase, a key link between alpha synuclein (the main component of Lewy bodies) and neuroinflammation.

• Preclinical studies showed reversal of cholinergic deficits and degeneration, with findings published in major scientific journals.

Clinical trial results and interpretation

• Phase 2a and 2b studies demonstrated that clinical efficacy is concentrated in patients without AD co-pathology, as identified by the blood test.

• An initial batch of capsules underperformed due to manufacturing issues, but subsequent batches achieved target blood concentrations and showed significant clinical effects.

• Achieving therapeutic drug levels led to reduced progression on the CDR Sum of Boxes and improvements across multiple endpoints, including cognition and motor function.

• Kaplan-Meier analysis showed a 65–74% reduction in risk of progression compared to placebo, with biomarker data supporting clinical findings.