Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 83

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 83
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 with millions more impacted worldwide.1,2 Studies estimate that approximately 10-30% of individuals
who contract COVID-19 experience lingering symptoms 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, 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.

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