Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 86

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 86
---
 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
regarding the design and endpoints for definitive Phase 3 clinical testing of BIV201.

Our proprietary novel liquid formulation of terlipressin
is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute
the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled
syringe in storage for 2 years, with the potential for up two years stability. Room temperature storage presents a key product differentiation
versus terlipressin products in countries where the drug is approved. To the best of the Company’s knowledge, all other terlipressin
products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating
patients in these countries. BioVie has also filed a Patent Cooperation Treaty (“PCT”) application covering our novel liquid
formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have
been granted in the U.S. (Patent no. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68.965), China (Patent No. ZL 202080050758.X),
and Japan (7579811).

We believe BIV201 (continuous infusion terlipressin)
has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due
to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation