CervoMed (CRVO) investor relations material

Company overview and strategic direction

• Developing neflamapimod, an oral drug targeting neurodegenerative disorders, with a focus on dementia with Lewy bodies (DLB); positive phase IIa and IIb data support advancement to phase III, pending financing.

• Recently closed a $10.5 million private placement, extending cash runway into Q2 2027 and enabling continued clinical development and partnership pursuits.

• Strategic partnership is prioritized to fund phase III in DLB and potentially other indications, aiming to minimize dilution and maximize shareholder value.

• All regulatory requirements for phase III initiation are met, including CMC, non-clinical, and toxicology studies, with a new 50 mg dose formulation ready.

• Internal resources are focused on advancing clinical programs and securing a partnership within the extended runway.

Clinical development and pipeline progress

• Phase III trial in DLB is designed as a single, 300-patient study with CDR Sum of Boxes as the primary endpoint, agreed upon by FDA, EMA, and MHRA.

• The trial targets pure DLB patients, using a blood test to exclude Alzheimer’s co-pathology, enhancing outcome quality and pricing leverage.

• Additional clinical catalysts include a biomarker and clinical endpoint readout in non-fluent primary progressive aphasia (PPA), with robust enrollment nearing completion.

• ALS study initiation is planned by year-end, leveraging the same dosing regimen as DLB phase III, based on mechanistic rationale and recent publications.

• Data presentations are anticipated at major neurology meetings in the fall, potentially providing early biomarker results from the PPA study.

Mechanism of action and clinical data

• Neflamapimod targets neuroinflammation, specifically interleukin-1 beta signaling, to protect cholinergic neurons in the basal forebrain, a key driver of DLB symptoms.

• MRI and biomarker data show stabilization and increased volume of basal forebrain cholinergic neurons, correlating with clinical improvements.

• Phase IIa and IIb studies demonstrate improvement in CDR Sum of Boxes for DLB patients without Alzheimer’s co-pathology, supporting the targeted mechanism.

• The drug’s effect is internally and externally consistent with current scientific understanding of DLB pathophysiology.

• Symptomatic therapies for AD provide limited benefit in DLB, while neflamapimod addresses the underlying disease process.