Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 85

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 85
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, and alcoholism. The initial target for BIV201 therapy was refractory ascites.
These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
an estimated 50% mortality rate within 6 to 12 months.

After receiving guidance from the FDA regarding
the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting
a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus
on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis
and ascites who have recently recovered from acute kidney injury (“AKI”). This patient population is not limited to those
having refractory ascites. BIV201 is administered as a 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.

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