CervoMed (NasdaqCM:CRVO) FY Conference Transcript

Summary of CervoMed FY Conference Call (September 08, 2025) Company Overview - Company: CervoMed (NasdaqCM:CRVO) - Focus: Development of therapies for dementia with Lewy bodies (DLB) Industry Context - Unmet Medical Need: High unmet medical need for DLB with no approved therapies available, only symptomatic treatments that do not address the underlying disease process [2][3] - Patient Population: Approximately 175,000 patients diagnosed with pure DLB in the U.S. [1] Core Drug Mechanism and Clinical Evidence - Drug Mechanism: The drug is an inhibitor of P38 alpha MAP kinase, which is linked to neuroinflammation and cholinergic neuron dysfunction in DLB [3][4] - Clinical Proof of Concept: The drug has demonstrated efficacy against significant clinical endpoints, particularly in cognition and dementia severity [3][5] - Phase IIa Study Results: Showed translatable effects on cognition and dementia severity in humans, with a focus on patients without Alzheimer's disease (AD) co-pathology [5][6] Recent Clinical Trials - Phase IIb Study (REWIND LB): Focused on patients with DLB, using a blood test to enrich for those without AD co-pathology [5][6] - Initial Results: The first sixteen-week placebo-controlled phase did not show an effect due to issues with a specific batch of capsules [6][7] - Subsequent Analysis: A new batch of capsules was introduced, leading to effective dosing and significant clinical effects observed in later phases [8][11] Key Findings from Clinical Trials - Dementia Rating Scale (CDR Sum of Boxes): The primary endpoint showed significant improvement when therapeutic blood concentrations were achieved [10][11] - Statistical Significance: The results indicated a 65% reduction in the risk of progression against placebo, with a 74% reduction observed with the effective drug batch [15][16] - Biomarker Evidence: Plasma biomarkers indicated a significant clinical progression reduction, supporting the efficacy of the drug [16] Future Plans and Financial Considerations - Regulatory Strategy: Plans to present trial data to regulatory agencies, aiming for a 24-week clinical trial with approximately 300 patients [17] - Financial Outlook: The company is financed through Q3 of the following year, with an estimated $50 million to $75 million needed for the Phase III trial, likely closer to $70 million to $75 million [19][20] Conclusion - Next Milestone: The company is on track to meet with the FDA for feedback in Q4 of this year, which will inform the next steps in their clinical development program [17][18]