Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 29

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 29
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 timely develop new drugs, we could be forced to discontinue our operations.

Development and extensive testing will be required
to determine the technical feasibility and commercial viability of BIV201 and bezisterim (NE3107). Our success will depend on our ability
to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely
basis. Drugs that we may develop are not likely to be commercially available, at a minimum, for several years, if ever. Our drug product
candidate, BIV201 (continuous infusion terlipressin), was cleared by the FDA to undergo testing in a mid-stage (Phase 2b) clinical trial
for the treatment of refractory ascites due to cirrhosis. On June 24, 2021, we announced that the first patient has been enrolled in this
study. In March 2023, the open-label trial was stopped after 15 of the planned 30 patients were enrolled, and an evaluation of those completed
patients assessed. Encouraging data from these patients appeared to show that treatment with BIV201 plus SOC resulted in a reduction in
ascites fluid accumulation during treatment versus pre-treatment. In June 2023, the Company requested and subsequently received guidance
from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic
liver cirrhosis. Over three years since the initial enrollment of this clinical trial, the Company is continuing to finalize protocol
designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

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The proposed development schedules for our product
candidates may be affected by a variety of factors, including technological difficulties, proprietary technology of others, and changes
in government regulation, many of which will not be within our control. In June 2021, FDA approved the drug aducanumab for treatment of
Alzheimer’s despite a strong recommendation against approval from an FDA advisory committee. That FDA approval has generated significant
medical and political controversy, including a Congressional investigation, announced on June 25, 2021, into the basis for FDA’s
approval decision. That investigation, other potential investigations, and negative publicity of FDA’s approval decision could adversely
impact the agency’s oversight of our clinical development program, how the agency may view and act upon any NDA we may file for
bezisterim (NE3107