Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 38

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 38
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IV201
and bezisterim (NE3107), our product candidates, we have limited experience in conducting or supervising clinical trials that must be
performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for
drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine
safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including
the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such
trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be
approved for sale which could have a materially adverse effect on our business.

We depend upon our management and their loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business.

We currently depend upon the efforts and abilities
of our executive management team of Cuong Do, our Chief Executive Officer-President; Wendy Kim, our Chief Financial Officer; Dr Joseph
Palumbo, our Executive Vice President-Chief Medical Officer; Penelope Markham, our Senior Vice Ascites Programs & Strategic Initiatives-;
Chris Reading, our Senior Vice President-Alzheimer’s Disease Program; Clarence Ahlem, our Senior Vice President - Operations President-Operations,
Discovery and Parkinson’s Disease Program; ; and David Morse, our Senior Vice President-Chief Regulatory Officer; who all serve
the Company full-time. The loss or unavailability of the services of any of these individuals for any significant period of time could
have a material adverse effect on our business, prospects, financial condition and results of operations which may cause you to lose all
of your investment. We have not obtained, do not own, nor are we the beneficiary of key-person life insurance.

<div align='center'>17</div>

We may not be able to attract and retain highly skilled personnel, which could have a materially adverse effect on our business.

Our ability to attract and retain highly skilled
personnel is critical to our operations and expansion. We face competition for these types of personnel from other pharmaceutical companies
and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other
resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or