BioVie (BIVI) Corporate presentation summary

Lead assets and therapeutic focus

• Bezisterim (formerly NE3107) targets TNFα, reducing inflammation and insulin resistance, and shows promise in Parkinson's, Alzheimer's, and Long COVID clinical trials.

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

• Priorities include Parkinson's Phase 2b data, Long COVID Phase 2 topline results, and launching Phase 3 trials for ascites and Alzheimer's upon securing funding.

Clinical development highlights

• Bezisterim improved motor control and morning symptoms in Parkinson's, with a larger proportion of patients achieving >30% improvement compared to controls.

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

• In Alzheimer's, bezisterim showed cognitive and functional benefits comparable or superior to approved monoclonal antibodies, with a benign safety profile.

• BIV201 reduced ascites volume by 53% in patients completing treatment, compared to a 3.1% increase in standard of care.

Mechanism of action and scientific rationale

• Bezisterim is a first-in-class, orally bioavailable small molecule that crosses the blood-brain barrier and modulates ERK and NFκB pathways.

• Targets chronic low-grade inflammation, insulin resistance, and DNA methylation, all implicated in neurodegeneration and aging.

• Demonstrated reduction in DNA methylation and biological age in treated subjects, as measured by multiple epigenetic clocks.