Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 87

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 87
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 for ascites
(due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet
medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early
readmissions. According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience
an average hospital stay lasting eight days incurring over $86,000 in medical costs. This translates into a total potentially addressable
ascites market size for BIV201 therapy exceeding $650 million based on Company estimates.

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The FDA has never approved any drug specifically
for treating ascites. After receiving guidance from FDA in 2023 and again in 2025, the Company is currently finalizing the protocol design
for a Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and
disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”).

The BIV201 development program was initiated by
LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns
all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,
between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales
of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant
to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will
be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,
and The Barrett Edge, Inc.

Intellectual Property

BIV201

BioVie relies on a combination of patent, trade
secret, other intellectual property laws (such as FDA data exclusivity), nondisclosure agreements, and other measures to protect our proposed
products. We require our employees, consultants, and advisors to execute confidentiality agreements and