BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company developing drug candidates for liver disease and neurological conditions. The company generates no product revenue, funding operations through equity issuances, including multiple common stock and warrant offerings as disclosed in its 10-K filed August 15, 2025. Its two lead programs are BIV201, a patent-pending liquid formulation being prepared for a Phase 3 study in patients with cirrhosis and ascites who have recently recovered from acute kidney injury, with patents issued in the US, China, Japan, Chile, and India as of the filing date, and bezisterim (NE3107), an oral small molecule that failed co-primary endpoints in a Phase 3 trial (NCT04669028) for mild to moderate Alzheimer's disease, results announced November 29, 2023. The company faces a consolidated securities class action, In re BioVie Inc. Securities Litigation (No. 3:24-cv-00035), filed in the U.S. District Court for the District of Nevada, alleging material misrepresentations related to the bezisterim trial. CEO is Cuong Do and CFO is Joanne Wendy Kim, as of August 15, 2025.

Revenue model

Pre-revenue. Operations are funded through equity capital raises, including issuances of common stock and warrants. No product sales or licensing revenue is disclosed in the 10-K filed August 15, 2025.

Products and services

BIV201: patent-pending liquid formulation in Phase 3 protocol development for cirrhosis and ascites patients recovering from acute kidney injury; patents issued in US, China, Japan, Chile, and India. Bezisterim (NE3107): oral small molecule that did not meet co-primary endpoints (ADAS-Cog 12 and CDR-SB) in a Phase 3 Alzheimer's disease trial (NCT04669028), results disclosed November 29, 2023.

Customers and end markets

No commercial customers. Target patient populations are adults with cirrhosis and ascites (particularly those recovering from acute kidney injury) and patients with mild to moderate Alzheimer's disease. End markets are hospital and specialty hepatology and neurology settings, subject to FDA approval.

Value-chain role

Clinical-stage drug developer with no internal commercial manufacturing. Relies on third-party contract manufacturers subject to FDA Good Manufacturing Practice regulations. Regulatory pathway runs through the FDA, with potential future international submissions.

Geographic exposure

Primary regulatory focus is the United States (FDA). BIV201 patents are issued in US, China, Japan, Chile, and India as of the filing date. International clinical and regulatory activity is noted as possible but not yet underway per the 10-K filed August 15, 2025.

Source: SEC 10-K, filed 2025-08-15

Industry: Pharmaceutical Preparations Peers: Akebia Therapeutics Inc AquaBounty Technologies Inc Unity Biotechnology, Inc. Disc Medicine Inc GT Biopharma Inc EOM Pharmaceutical Holdings, Inc. Palatin Technologies Inc Sensei Biotherapeutics Inc Solid Biosciences Inc