Company: BIVIW
Filing Date: 2025-10-06
Form Type: POS AM
Source: 0001520138-25-000294
Chunk: 7

Company: BIOVIE INC.
Filing Date: 2025-10-06
Form: POS AM
Chunk 7
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 as LID, which is exacerbated by high dose levodopa. Although levodopa provides
symptomatic benefit, it does not slow PD progression.

| 2 |

The Company designed a new Phase 2b study of bezisterim
as a potential first line therapy to treat patients with new onset PD. This trial will be evaluating the safety and efficacy of bezisterim
on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa. The PD Phase 2b study comprises
a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial
screening phase to the safety follow up. In July 2024, the Company submitted the new protocol and received a response from the FDA permitting
the Company to proceed with the study. The trial commenced in April 2025.

The Phase 2 study of bezisterim for the treatment
of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
study in PD participants treated with carbidopa/levodopa and bezisterim. Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim 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
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.

B. Long COVID Program

About Long COVID

Long COVID is a condition in which symptoms of COVID-19,
the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more. Common symptoms
include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory
problems, muscle weakness, and neurologic issues have also been documented.

Approximately 20 million individuals in the U.S. currently
or previously have long COVID, with millions more impacted worldwide. Studies estimate that approximately 10-30% of individuals who contract
COVID-19 experience lingering symptoms