Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 160

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 160
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 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.

Neurodengenerative Disease Program

In neurodegenerative disease, the Company’s
drug candidate 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. 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.

Alzheimer’s Disease (NCT05083260)

On November 29, 2023, the Company announced the analysis
of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive
sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
twice daily.

Upon trial completion, as the Company began the
process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices
(“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level
of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of
Scientific Investigations (“OSI”) for potential further action. After the patient exclusions, 81 patients remained in
the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial
and were verified to take study drug from pharmacokinetic data.

The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned