Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 37

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 37
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 carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric
activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

To extend this Phase 2 data in progressed patients,
the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset
PD. In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with
the study. The trial commenced in April 2025.

Long COVID Program

In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed
Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development
Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating
neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence in May 2025.

Liver Disease Program

In liver disease, our investigational drug candidate BIV201 (continuous
infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated as
a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by
non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was refractory ascites. These patients
suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50%
mortality rate within 6 to 12 months.

After receiving guidance from the FDA regarding the
design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a
broader ascites patient population. The Company is currently finalizing the protocol design for the