Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 193

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 193
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(unaudited)</div>

| 1. | Background Information |

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.

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 beziisterim
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 and 1 million Americans suffering from PD.

Neurodegenerative Disease Program

In neurodegenerative disease, the Company’s drug candidate bezisterim
(NE3107) inhibits activation of inflammatory actions 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. Bezisterim (NE3107) does not interfere with their
homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of
AD and PD.

Parkinson’s Disease

To extend the Phase 2 data in progressed patients
from the previous Phase 2 study that completed in December 2022, the Company designed a new Phase 2 study of bezisterim (NE3107) as a
potential first line therapy to treat patients with new onset PD. In July 2024, the Company submitted the new protocol and received a
response from the FDA which permitted the Company to proceed with the study. The trial commenced in April 2025.

The previous Phase 2 study of bezisterim (NE3107)
for the treatment of PD