Company: BIVIW
Filing Date: 2025-05-15
Form Type: DRS
Source: 0001520138-25-000149
Chunk: 6

Company: BIOVIE INC.
Filing Date: 2025-05-15
Form: DRS
Chunk 6
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 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, insulin-sensitizer that is also
anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim inhibits activation
of inflammatory action 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 and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
improvements in several disease indications, including PD, AD and long COVID.

BioVie has conducted and reported efficacy data
on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who
have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bez