Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 73

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 2
Chunk 73
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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 (“LC”) affects approximately 20 million adults in the US, and millions more worldwide.

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.g., insulin signaling and neuron growth and survival). Both
inflammation and insulin resistance are drivers of AD and PD.

Chronic neuroinflammation, insulin resistance,
and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and
Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential
anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated
inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s
work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada,
Europe and South Korea.

Parkinson’s Disease 

PD is driven in large part by neuroinflammation
and activation of brain microglia