Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 105

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 105
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 fiduciary duty, unjust enrichment,
abuse of control, and waste of corporate assets 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

Other than as described below, there have been no material changes
to the Risk Factors previously disclosed in our Annual Report on Form 10-K filed with the SEC on September 30, 2024 (the “2024 Form
10-K”), our quarterly report for the period ended September 30, 2024 (the “Q1 2025 10-Q”) and our quarterly report for
the period ended December 31, 2024 (the “Q2 2025 10-Q”). The risks described in our 2024 Form 10-K, our Q1 2025 10-Q, our
Q2 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 course of our clinical trials,
and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring that each of our
studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our
reliance on third parties does not relieve the Company of our regulatory responsibilities. We and these third parties are required to
comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct
of clinical trials on