BioVie (BIVI) Investor Update summary

Clinical trial progress and timelines

• Parkinson's phase II trial enrollment has accelerated, with full enrollment projected by end of 2025 and top-line data expected in April or May 2026.

• Long COVID phase II trial is enrolling well, with further guidance on full enrollment expected within a month and data readout anticipated in mid-2025.

• Ascites phase III protocol was submitted to the FDA three weeks ago, with feedback expected soon; trial start is pending funding.

• Sufficient cash runway extends through the end of 2026, covering all major trial readouts.

Drug candidates and mechanisms

• Lead asset bezisterim modulates TNF-alpha, reducing inflammation and insulin resistance, and has shown improved muscle control in Parkinson's and cognitive function in Alzheimer's.

• BIV201 targets ascites, a condition with over 50% mortality in 12 months, and has shown a 50% reduction in ascites volume in phase II.

• Bezisterim blocks activation of ERK and NF-kappa B, preventing TNF-alpha production and its downstream effects.

Market potential and financial outlook

• Bezisterim for Parkinson's is estimated to have $3–5 billion annual U.S. sales potential at 10% market penetration.

• BIV201 for ascites could reach $1.6–2 billion in annual U.S. sales.

• Current market cap is $15 million, with significant upside if clinical milestones are met.