Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 31

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 31
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 in any one of our clinical trials
in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications.
We also do not know what the long-term effects of exposure to our product candidates will be. Furthermore, our product candidates may
be used in combination with other treatments and there can be no assurance that such use will not lead to unique or unexpected safety
issues.

Failure to complete clinical trials or to prove
that our product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require
us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.

We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited human capital and financial
resources, we focus on research programs and drug candidates that we identify for specific indications. As a result, we may forego or
delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our
spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially
viable drugs. If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish
valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have
been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

<div align='center'>15</div>

At any time and for any reason, we may determine
that one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to
warrant the allocation of resources toward such program or drug candidate. Accordingly, we may choose not to develop a potential drug
candidate or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates
or programs. For example, BIV201 has received Orphan Drug designation for HRS. On June 23, 2021, we announced that FDA has provided guidance
on our planned Phase 3 clinical trial of BIV201 in (HRS-AKI) and have since reached agreement on the key elements of the trial design.
There