Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 22

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 22
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 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 July 10, 2025, 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 U.S. District Court for the District of Nevada,
naming the Company and certain of its officers as defendants. On February 22, 2024, a second