Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 23

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 23
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 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 the timing and cost of clinical trials; and our ability to enter into favorable
alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and
distribution.

Even if we successfully develop and market BIV201
and/or bezisterim (NE3107), we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause
us to cease operations and cause you to lose all of your investment.

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

Once a NDA is approved, the product covered thereby
bec