Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 22

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 22
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 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 and believes that it is not exposed to any significant
credit risk in cash and cash equivalents. Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse
developments that affect financial institutions, or concerns or rumors about such events, may lead to liquidity constraints. In 2023,
certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity
concerns, which caused general heightened uncertainties in financial markets. While previous bank failures have not had a material direct
impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial
institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements
may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, all of which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our Common Stock.

We are, and may in the future become, subject
to various legal proceedings and claims that arise in or outside the ordinary course of business. For example, On January 19, 2024, a
purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the