Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 161

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 161
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 exclusion of so many patients has 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 of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic
change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test
was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation
data continues to be collected and analyzed.

Parkinson’s Disease (NCT05083260)

The Phase 2 study of bezisterim (NE3107) for the treatment
of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives:
1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the 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.

F-8

| 1. | Background Information (continued) |

Long COVID Program

In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the DOD, awarded through the Peer Reviewed
Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”). The award
can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107)