Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 9

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 9
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 patent-pending liquid formulation with patents issued in the U.S., China, Japan,
Chile and India to date. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid
in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. BIV201 is a continuous infusion of terlipressin, a drug
used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal varices)
that was approved in the U.S. in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function)
but is not approved in Japan. With its novel room temperature stable formulation in a pre-filled syringe, we believe BIV201 could potentially
provide a superior terlipressin drug delivery system throughout the world. The goal of BIV201 therapy is to target the pathophysiology
that contributes to ascites production, acute kidney injury and complications of cirrhosis that are associated with significant mortality.

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In June 2021, BioVie initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period. By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment
on May 8, 2023. In March 2023, enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to
show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.
The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment
with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment
initiation as compared to the three-month pre-treatment period. In June 2023 and December 2024, BioVie received guidance from the FDA
reg