Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 38

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 38
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 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 (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period.

 22 

Comparison of the three months ended March 31, 2025 to the three months
ended March 31, 2024

Net loss

The net loss for the three months ended March
31, 2025 was approximately $2.8 million as compared to the net loss of $8.1 million for the three months ended March 31, 2024. The net
decrease of $5.3 million is due to a decrease in research and development expenses of $4.4 million, decrease in selling, general and administrative
expenses of approximately $388,000, and a decline in other expense of approximately $536,000.

Total operating expenses for the three months
ended March 31, 2025 were approximately $3.0 million