Company: BIVIW
Filing Date: 2025-05-15
Form Type: DRS
Source: 0001520138-25-000149
Chunk: 13

Company: BIOVIE INC.
Filing Date: 2025-05-15
Form: DRS
Chunk 13
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 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.

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.

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Recent Developments

On May 9, 2025, the Company filed a preliminary
proxy statement for purposes of calling a special meeting of the Company's stockholders to seek approval of a proposal to grant the Board
of Directors of the Company authority, in its sole discretion, prior to the one-year anniversary of such special meeting, to effect a
reverse stock split of the outstanding shares of Common Stock, at a ratio between 1-for-5 and 1-for-10. The special meeting will be held
on June 23,