Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 19

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 19
---
 violates applicable federal,
state, or foreign laws and/or regulations, including but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims
laws, healthcare privacy and data security laws, or provide us or government agencies with inaccurate, misleading, or incomplete data.

Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

Product candidates that appear promising in the
early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show the product candidate
to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects.
Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things,
such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional time requirements
for data analysis; IND and later new drug application preparation; discussions with the FDA; an FDA request for additional pre-clinical
or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites deviating
from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements - which can render data from
those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary rights of others
and their competing products and technologies may also prevent the product from being commercialized.

<div align='center'>10</div>

Success in pre-clinical and early clinical studies
does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations
that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application
for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult
to predict. There can be no assurance that any of our products will develop successfully, and the failure to develop our products will
have a materially adverse effect on our business and will cause you to lose all of your investment.

The concentration of our assets within a certain financial institution could have a material adverse effect on its business, financial condition and results of operations.

As of the date of this prospectus, the Company
had cash deposited in a certain financial institution in excess of federally insured levels. The Company regularly monitors the financial
stability of these financial institutions