Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 33

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 33
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 or drug product manufacturing for BIV201 and bezisterim (NE3107), we may
not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonably terms, or at all. If we are
unable to do so, we will need to develop our own commercial-scale manufacturing capabilities, which would: impact commercialization of
BIV201 and bezisterim (NE3107) in the U.S. and other countries where it may be approved; require a capital investment by us that could
be quite costly; and increase our operating expenses.

If our existing third-party manufacturers, or
the third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to
continue to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to
meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers. If for any reason we are
unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture
it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products. In addition, if we are
unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity
to which the product otherwise would be entitled.

We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.

We are an early stage development company with
limited resources. Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff
at this early stage of operations to sell products. We cannot generate sales without sales or marketing staff and must rely on others
to provide any sales or marketing services until such personnel are secured, if ever. If we fail to hire and retain the requisite expertise
in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff,
then we could be forced to cease operations and you could lose all of your investment.

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Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations, which could have a materially adverse effect on our business.

If we