Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 24

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 24
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 possible cost to
us from this matter, as the pending lawsuit is currently at an early stage, and we cannot be certain how long it may take to resolve the
pending lawsuit or the possible amount of any damages that we may be required to pay. Monitoring, initiating and defending against legal
actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources
on our business activities. We could be forced to expend significant resources in the settlement or defense of the pending lawsuit and
any potential future lawsuits, and we may not prevail in such lawsuits.

Although we have insurance coverage that we believe
applies to these actions, the coverage is subject to a $2 million deductible. That means that we are responsible for the first $2 million
of 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;