Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 35

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 35
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 any forward-looking
statements contained in this report as a result of new information or future events or developments, except as required by law. Thus,
you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking
statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the
Securities and Exchange Commission (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other
factors that may affect our business. 

The following discussion of the Company’s financial
condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere
in this report. 

Management’s Discussion

BioVie Inc. (the “Company” or “we”
or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
neurological and neuro-degenerative disorders and 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. In April 2024, the Company announced that the United States Adopted Names Council, and the World
Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic)
name for NE3107. Bezisterim (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 AD and PD, and bezisterim (NE3107) could,
if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million
Americans suffering from AD and 1 million Americans suffering from PD.

In neurodegenerative disease, bezisterim (NE3107)
inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”)
(including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
Bezisterim (NE3107) does not interfere with their homeostatic functions (e