Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 17

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 17
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 exercise price equal to 125% of the offering price of our Common Stock.                            |

<div align='center'>9

Risk Factors</div>

Investing in shares of our Common Stock involves a high degree of risk. Before deciding whether to invest in shares of our Common Stock, you should consider carefully the risks and uncertainties discussed in this prospectus and any prospectus supplement and any free writing prospectus that we may authorize. Please also read carefully the section titled “Cautionary Note Regarding Forward-Looking Statements.”

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