Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 196

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 196
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ognitive 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.

F-30

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 (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 exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing