Company: BIVIW
Filing Date: 2025-10-06
Form Type: POS AM
Source: 0001520138-25-000294
Chunk: 5

Company: BIOVIE INC.
Filing Date: 2025-10-06
Form: POS AM
Chunk 5
---
 does not contain all of the information that you should consider before making an investment decision. For a more complete understanding of the Company, you should read and consider carefully the more detailed information included in this prospectus and in the documents incorporated by reference herein, including the factors described under the heading “Risk Factors” on page 7 of this prospectus and in the documents incorporated by reference herein, before making an investment decision.

Overview of the Company

We are a clinical-stage company developing innovative
drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

Neurodegenerative Disease Program

The Company acquired the biopharmaceutical assets
of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021.
The acquired assets included NE3107 (or “bezisterim”). Bezisterim, the approved generic name for NE3107 is an investigational,
novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory
cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play
fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”),
and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach
to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD , 1 million Americans suffering
from PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide.

In neurodegenerative disease, the Company’s
drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, and anti-inflammatory agent that
is an insulin-sensitizer. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim inhibits activation
of inflammatory extracellular single regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B
cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory
pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFκB activation and
TNF-α production bezisterim does not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical