BioVie (BIVI) Status update summary

Pipeline and clinical trial updates

• Bezisterim (NE3107) is in phase II trials for Parkinson's and long COVID, with top-line data expected in Q2 and late summer 2024, respectively.

• Parkinson's trial is fully enrolled; last patient visit expected by end of April, with data readout by May or June.

• Long COVID trial is rapidly enrolling at major academic centers, with last patient visit in July and data readout in August.

• BIV201 for ascites completed phase II trials, showing over 50% reduction in fluid buildup; phase III trial planning underway.

• FDA feedback received for BIV201; company exploring funding and potential spin-out to advance to phase III.

Drug mechanism and therapeutic focus

• Bezisterim modulates inflammation by blocking TNF-alpha via selective inhibition of inflammatory ERK, impacting insulin resistance and neurodegeneration.

• Demonstrated efficacy in preclinical and clinical studies for improving muscle control in Parkinson's and cognition in Alzheimer's.

• Combination of Bezisterim and Levodopa showed synergistic effects and neuroprotection in animal and human studies.

• BIV201 is a novel formulation of Terlipressin for ascites, delivered via continuous infusion to minimize side effects.

Market opportunity and strategic priorities

• Parkinson's market opportunity estimated at $3–$5 billion annually in the U.S.; long COVID market could be even larger due to high prevalence.

• BIV201 for ascites could reach $2 billion in annual U.S. sales.

• Strategic priority is Parkinson's, followed by long COVID, with flexibility to shift based on trial results and FDA guidance.

• Accelerated approval or emergency use authorization may be pursued for long COVID if phase II results are strong.