Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 27

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 27
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 and Orphan Drug Exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked
for seven years by the other company’s Orphan Exclusivity and they may obtain a competitive advantage even after the exclusivity
period expires associated with being the first to market.

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We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms, which could have a materially adverse effect on our business.

Developing biopharmaceutical products, including
conducting pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires substantial funding. Additional
financing will be required to fund the research and development of our product candidates. We have not generated any product revenues,
and do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the
FDA and other regulatory authorities for our product candidates.

We may not have the resources to complete the
development and commercialization of any of our proposed product candidates. We will require additional financing to further the clinical
development of our product candidates. In the event that we cannot obtain the required financing, we will be unable to complete the development
necessary to file an NDA with the FDA for BIV201 or bezisterim (NE3107). This will delay or require termination of research and development
programs, preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own
laboratory or a search for third party marketing partners to market our products for us, which could have a materially adverse effect
on our business.

The amount of capital we may need will depend
on many factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of
our preclinical studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to
establish our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market
developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative,
licensing and other commercial relationships that we may establish.

Until we can generate a sufficient amount of product
revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings, or corporate collaboration
and licensing arrangements. Additional funds