Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 31

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 31
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 but they may not be able to successfully
develop any drugs. Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability to
develop products internally or to obtain rights to them from others on favorable terms; complete laboratory testing and human studies;
obtain and maintain necessary intellectual property rights to our products; successfully complete regulatory review to obtain requisite
governmental agency approvals; enter into arrangements with third parties to manufacture our products on our behalf; and enter into arrangements
with third parties to provide sales and marketing functions. If we are unable to achieve these objectives we will be forced to cease operations
and you will lose all of your investment.

Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. Consequently, we can provide no assurance that our product candidates will obtain regulatory approval, and if we are unsuccessful or fail to 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 asc