Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 22

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 22
---
 loss arising from these actions, which includes both defense costs and damages, before any insurance coverage will apply. Furthermore,
our insurance coverage may be insufficient, and our assets may be insufficient to cover any amounts that exceed our insurance coverage,
and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claim. A decision adverse
to our interests in the pending lawsuit, or in similar or related litigation, could result in the payment of substantial damages, or possibly
fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial condition.
We have not established any reserve for any potential liability relating to the pending lawsuit or any potential future lawsuits. Any
such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, operating
results or financial condition. In addition, such lawsuits may make it more difficult to finance our operations and affect our ability
to make payments for damages.

<div align='center'>11</div>

We have no products approved for commercial sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.

We have no products approved for commercial sale
and, to date, we have not generated any revenue. Our ability to generate revenue depends heavily on (a) successful completion of one or
more development programs demonstrating in human clinical trials that BIV201 and bezisterim (NE3107), our product candidates, are safe
and effective; (b) our ability to seek and obtain regulatory approvals, including, without limitation, with respect to the indications
we are seeking; (c) successful commercialization of our product candidates; 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,