Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 39

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 39
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The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to curtail or cease operations.

The biotechnology and biopharmaceutical industries
are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological
factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize
technological developments and the ability to obtain government approval for testing, manufacturing and marketing.

We compete with biopharmaceutical firms in the
United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to
their operations. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area. Many major pharmaceutical
companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical
companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete with
us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies
in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us.

Although there are not currently any therapies
approved by the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market
risk. Other companies, such as Ocelot Bio, are developing therapies for severe complications of advanced liver cirrhosis, which may in
the future be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our product candidate.
Similarly, other companies, such as Biogen and Eli Lilly, are developing treatments for AD and PD, which could compete indirectly or directly
with our product candidate. There may be other competitive development programs of which we are unaware. Even if our product candidates
are ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt them in favor of current ascites
treatment procedures such as diuretics and paracentesis with respect to BIV201 and AD and PD with respect to bezisterim (NE3107). These
competitive and market risks 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.

Our competition will be determined in part by
the potential indications for