Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 10

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 10
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2024, U.S. Army Medical Research and Development Command, Office of Human Research Oversight
(“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated
with long COVID. and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim allowing the Company
to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms associated with long covid.

The Phase 2 ADDRESS-LC study, which is fully funded
by a grant from the DOD, is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability
of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. Individuals who have been diagnosed
with long COVID and have neurocognitive dysfunction and self-reported fatigue may meet qualification criteria and can visit www.addressLC.com
to learn more.

<div align='center'>3</div>

The trial commenced in May 2025. As of April 2025, the Company was
reimbursed approximately $2.9 million for trial costs incurred for the nine months ended March 31, 2025.

C. 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 bezisterim in the treatment of mild
to moderate AD. The study had 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 bezisterim 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