Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 33

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 33
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 if positive results are observed in clinical trials. In some instances,
there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due
to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations,
changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants. If the results of
our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical
endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates,
we may be delayed in obtaining marketing approval, if at all. Additionally, any safety concerns observed 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.

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At any time and for any