Company: BIVIW
Filing Date: 2025-02-11
Form Type: 10-Q
Source: 0001520138-25-000056
Chunk: 13

Company: BIOVIE INC.
Filing Date: 2025-02-11
Form: 10-Q
Item: Part I, Item 2
Chunk 13
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 and plaintiffs filed their opposition on October
21, 2024. The defendants’ reply brief was filed December 5, 2024. The defendants believe that the claims are without merit and intend
to defend vigorously against them, but there can be no assurances as to the outcome.

On December 30, 2024, a shareholder derivative lawsuit was filed in the
United States District Court for the District of Nevada by putative stockholder Andrew Hulm, allegedly on behalf of the Company, that
piggy-backs on the securities class action also pending in that court. The derivative complaint names certain current and former officers
and directors as defendants, and generally alleges that they breached their fiduciary duties by causing or failing to prevent the securities
violations alleged in the securities class action. The derivative complaint also alleges claims for unjust enrichment, waste of corporate
assets, gross mismanagement, and abuse of control as against all defendants. The defendants believe that the claims are without merit
and intend to defend vigorously against them, but there can be no assurances as to the outcome.

Item 1A. Risk Factors

There have been no material changes to the Risk Factors
previously disclosed in our 2024 Form 10-K and our quarterly report for the period ended September 30, 2024 (the “Q1 2025 10-Q”).
The risks described in our 2024 Form 10-K, our Q1 2025 10-Q and below are not the only risks facing our company. Additional risks and
uncertainties not currently known to the Company or that we currently deem to be immaterial also may materially adversely affect our business,
financial condition, and/or operating results.

Risks Relating to Our Business and Industry

We rely and will continue to rely on third parties
to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines
or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize
our product candidates.

We depend, and will continue to depend, on third parties,
including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial principal
investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including
those for our drug candidates bezisterim (NE3107) and BIV201. We rely heavily on these third parties over the