Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 29

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 29
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dt has already gained FDA approval for its product, lyophilized terlipressin acetate
for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022. PharmaIN Corporation received
Orphan Drug Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer. In addition, Ferring
Pharmaceuticals Inc. received Orphan Drug designation in 1986 for terlipressin for the treatment of bleeding esophageal varices. If one
of those or any other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives
FDA approval 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.

<div align='center'>13</div>

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