Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 97

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 97
---

BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis
caused by non-alcoholic steatohepatitis (NASH), hepatitis, 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 US, China, Japan, Chile
and India to date.

In June 2021, the Company 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 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