Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 25

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 25
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 and (d) market acceptance of our products. There are no assurances
that we will achieve any of the forgoing objectives. Furthermore, our product candidates are in the development stage, and have not been
fully evaluated in human clinical trials. If we do not successfully develop and commercialize our product candidates we will not achieve
revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may
be unable to continue our operations.

We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.

Although our Company was incorporated on April
10, 2013, we are a development stage biopharmaceutical company with potential therapies that have not been fully evaluated in clinical
trials, and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not
limited to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual
losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and limited
marketing experience, possible reliance on third parties for the development and commercialization of our proposed products, a competitive
environment characterized by numerous, well-established and well capitalized competitors and reliance on key personnel.

Since inception, we have not established any revenues
or operations that would provide financial stability in the long term, and there can be no assurance that we will realize our plans on
our projected timetable in order to reach sustainable or profitable operations.

Investors are subject to all the risks incident
to the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its
investment. Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern. We
have not emerged from the development stage, and may be unable to raise further equity. These factors raise substantial doubt about our
ability to continue as a going concern. The financial statements included elsewhere in this Form 10-K do not include any adjustments that
might result from the outcome of this uncertainty.

Because we are subject to these risks, you may
have a difficult time evaluating our business and your investment in our Company. Our ability to become profitable depends primarily on
our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research
and development (“R&D”) efforts, including