Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 111

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part II, Item 1A
Chunk 111
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Except as described below, there have been no
material changes to the Risk Factors previously disclosed in our 2025 Form 10-K. The risks described in our 2025 Form 10-K and below are
not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial
also may materially adversely affect our business, financial condition, and/or operating results.

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Table of Contents 

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 us 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 product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic
inspections and for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the
Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory
requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical
trials to support our marketing applications, which would delay the regulatory approval process. For example, our drug product candidate
bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multic