Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 12

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 12
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 secondary objective was to determine if
preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives
were met.

Long COVID Program

In April 2024, the Company announced the grant of a clinical trial
award of up to $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 (NE3107) for the treatment
of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating
neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence in May 2025. The Company was reimbursed
approximately $2.5 million and $2.8 million for trial costs incurred during the three and nine months ended March 31, 2025, respectively.
Subsequent to March 31, 2025, additional reimbursements of approximately $141,000 were received for trial costs incurred through March
31, 2025.

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Alzheimer’s Disease 

On November 29, 2023, the Company announced the analysis of its unblinded,
topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) 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 (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 (virt