BioVie (BIVI) Investor update summary

Pipeline and clinical trial updates

• Two imminent clinical data readouts expected: Parkinson's trial results in late July/early August and Long COVID trial results in late August/early September.

• Parkinson's trial has completed patient visits; data cleaning and biomarker analysis are underway.

• Long COVID trial is fully enrolled with 200 patients; last patient visit expected early to mid-August.

• Both trials are showing promising safety and early efficacy signals, with no severe drug-related adverse events reported.

• Positive results could lead to FDA discussions for accelerated approval or Emergency Use Authorization for Long COVID.

Drug mechanism and differentiation

• Lead asset bezisterim targets TNF-alpha, addressing inflammation and insulin resistance, key drivers in neurodegenerative diseases.

• Demonstrated ability to improve both motor and non-motor symptoms in Parkinson's and slow cognitive decline in Alzheimer's by 68% over six months.

• Distinct from amyloid- and tau-focused therapies, bezisterim blocks the master regulator of inflammation, potentially offering broader efficacy.

• Preclinical and clinical data suggest neuroprotective effects and improved neuronal health.

Market opportunity and financial status

• Estimated U.S. annual sales potential: $3–5 billion for Parkinson's, $10 billion for Long COVID, $1.5–2 billion for ascites, and $30 billion+ for Alzheimer's.

• Current market cap is $10 million, below cash balance; sufficient cash runway through year-end.

• Alzheimer's program on hold pending funding; two phase III trials would require $50–60 million.