BioVie (BIVI) Corporate presentation summary

Lead assets and therapeutic focus

• Bezisterim (formerly NE3107) targets TNFα, showing reduced inflammation, improved motor control in Parkinson's, and cognitive benefits in Alzheimer's clinical trials.

• BIV201 addresses ascites in cirrhosis, reducing fluid buildup and aiming to be the first approved therapy for this high-mortality condition.

• Priorities include completing Parkinson's Phase 2b and Long Covid Phase 2 trials, and launching Phase 3 trials for ascites and Alzheimer's upon securing funding.

Clinical development and trial results

• Parkinson's Phase 2b topline data expected 2Q26; Long Covid Phase 2 topline data expected Summer '26.

• Bezisterim demonstrated promotoric activity similar to L-dopa in animal models and reduced L-dopa-induced dyskinesia.

• In Parkinson's Phase 2, bezisterim improved morning motor symptoms and a higher proportion of patients achieved >30% motor improvement.

• Alzheimer's Phase 3 trial showed cognitive and functional efficacy signals comparable to or better than approved monoclonal antibodies, with a benign safety profile.

• BIV201 Phase 2b in ascites showed a 53% reduction in ascites volume for completers versus 3% increase for standard of care.

Mechanism of action and scientific rationale

• Bezisterim is a small molecule, orally bioavailable, crosses the blood-brain barrier, and reduces ERK and NFκB activation, key drivers of inflammation.

• Insulin resistance is linked to neurodegeneration in Parkinson's; bezisterim targets this pathway.

• In Alzheimer's, bezisterim modulates central inflammation hubs, potentially reducing downstream neurodegenerative cascades.

• In Long Covid, bezisterim may counteract persistent inflammation driven by viral proteins activating TLR4 and NFκB/ERK pathways.