Company: BIVIW
Filing Date: 2025-02-11
Form Type: 10-Q
Source: 0001520138-25-000056
Chunk: 14

Company: BIOVIE INC.
Filing Date: 2025-02-11
Form: 10-Q
Item: Part I, Item 2
Chunk 14
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 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 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.

Although we design the clinical trials for our product
candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects of our clinical development programs,
including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control, either
partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection,
management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees.
Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.
Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including
but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws,
or provide the Company or government agencies with inaccurate, misleading, or incomplete data.

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Risks Relating To Our Common Stock

You may experience future dilution as a result
of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

As of December 31, 2024, our Articles of Incorporation,
as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 18,478,307 shares of Common Stock