Company: BIVIW
Filing Date: 2025-10-06
Form Type: POS AM
Source: 0001520138-25-000294
Chunk: 8

Company: BIOVIE INC.
Filing Date: 2025-10-06
Form: POS AM
Chunk 8
---
 for months or even years, with fatigue, brain fog, and cognitive impairment significantly impacting
daily functioning and quality of life. Despite the growing recognition of long COVID as a serious condition, treatment options remain
limited, and many patients struggle to find effective relief for their symptoms. The loss in quality of life and earnings and increased
medical costs has an enormous economic impact estimated to be $3.7 trillion. To date there are no non-pharmacological or pharmacological
therapies proven effective for treatment of long COVID.

In April 2024, the Company was awarded a clinical
trial grant of $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research
Program of the Congressionally Directed Medical Research Programs. In August 2024, the FD&A and the U.S. Army Medical Research and
Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving
the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms
that are 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. The trial commenced in May 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 measuring cognitive impairment 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