BIOVIE INC.

BioVie Inc.

Overview

BioVie Inc. is a clinical-stage biopharmaceutical company developing therapies for neurological and neurodegenerative disorders, long COVID–related neurocognitive symptoms, and advanced liver disease.

Lead development programs

Bezisterim (NE3107)

• Modality and mechanism: Orally administered small molecule believed to inhibit inflammation-driven insulin resistance and key inflammatory pathways (ERK, NF-κB, TNF signaling) with selective modulation to avoid homeostatic disruption.
• Indications pursued: Alzheimer’s disease (AD), Parkinson’s disease (PD), and long COVID–related neurocognition.
• Regulatory and clinical status:
  • Parkinson’s disease: Phase 2b SUNRISE-PD trial completed; topline results announced August 2026 for 57 early PD patients naïve to symptomatic dopaminergic therapy. The primary pharmacodynamic endpoint was reduction in a composite neuroinflammation biomarker panel. Bezisterim showed a statistically significant improvement on the composite neuroinflammation measure and favorable signals on the EPNIC-15 motor/non-motor endpoint; overall tolerability was similar to placebo. The FDA has not validated the biomarker endpoints used in the PD study as surrogate endpoints.
  • Alzheimer’s disease: Phase 3 NM101 study (mild–moderate AD) reported unblinded topline efficacy data in November 2023. After identifying protocol deviations at certain sites, the company excluded data from those sites, which led to an underpowered analysis. The company intends to use the remaining data to inform the design of a potential pivotal Phase 3 trial.
• Status summary: No approved product; clinical data are preliminary and derived from limited cohorts.

BIV201 (continuous infusion terlipressin)

• Formulation: Patent-pending liquid, room-temperature stable formulation designed for continuous infusion of terlipressin.

• Indications pursued: Life-threatening complications of liver cirrhosis, specifically ascites and related complications (including in the context of hepatorenal syndrome).

• Regulatory and clinical status:

  • FDA: Fast Track designation and Orphan Drug designation for ascites related to liver cirrhosis.
  • Phase 2 program: Open-label study of BIV201 plus standard of care in refractory ascites (initiated 2021; 15 patients treated); results suggested reductions in ascites accumulation during and after treatment.
  • Phase 3 planning: Finalizing a protocol that focuses on a composite primary endpoint of complications and disease progression in cirrhosis patients with ascites who recently recovered from acute kidney injury.
  • Market context: Terlipressin is used in other settings (for example, hepatorenal syndrome), and BIV201 aims to enable outpatient administration advantages. The FDA has not approved terlipressin specifically for ascites.

• Intellectual property and ownership: BIV201 is licensed and developed under LAT Pharma LLC lineage with patents granted in multiple jurisdictions and ongoing PCT filings; patent protection continues through the 2030s and 2040s across various families.

Intellectual property (selected highlights)

• NE3107/bezisterim family (as of July 31, 2026): 12 issued U.S. patents; 7 pending U.S. patent applications; 3 pending U.S. PCT applications; 4 issued foreign patents; and 9 pending foreign applications directed to NE3107 and related compounds/methods.
• BIV201 (terlipressin formulations and methods): Issued patents in the U.S., India, Chile, China, Australia, Mexico, and Japan. U.S. patents include 11,364,277 and 12,685,756; European patent EP3347032 is issued. Additional U.S. and European patents (examples: U.S. 12,156,898; 11,364,277; 12,685,756; European 3347032) have expiration windows roughly in the 2030s–2040s, depending on jurisdiction and patent family.

Corporate and operations

• Public status: U.S. reporting company with securities listed on the Nasdaq Capital Market.
• Employees: 13 full-time employees.
• Management (full-time): Cuong Do (CEO/President); Dr. Joseph M. Palumbo (Executive Vice President, Chief Medical Officer); Wendy Kim (Chief Financial Officer and Corporate Secretary).
• Headquarters and offices:
  • Headquarters: 680 W Nye Lane, Suite 201, Carson City, NV 89703.
  • San Diego office: 5090 Shoreham Place, Suite 206, San Diego, CA 92122 (lease amended February 12, 2024; larger space; 60-month term with annual 4% increases).
• Revenue and profitability: No products approved for commercial sale and no reported revenue to date.
• Manufacturing and partnerships: The company uses third-party contract research organizations and contract manufacturing organizations for clinical trials and product manufacturing.

Financial position and capital needs

The company expects it will require substantial additional capital to fund ongoing development. Potential sources include public or private equity, debt financings, and collaboration or licensing arrangements. Future equity financings and milestone-driven stock issuances could result in dilution to existing shareholders.

Regulatory and development context

• FDA pathway: Candidates must complete standard regulatory sequences (preclinical work, IND, Phase 1–3 studies, NDA/BLA review, facility inspections, and any post-approval requirements) prior to U.S. commercialization.
• Orphan Drug designation: BIV201 has been granted Orphan Drug designation in the U.S. for hepatorenal syndrome and for ascites (non-cancer etiologies), which can provide market exclusivity if approvals are obtained.
• Expedited pathways: The company may pursue Fast Track or other expedited FDA pathways where applicable.
• International considerations: The company has pursued international IP protection and may face country-specific regulatory and market challenges.

Risk factors

• Drug development carries high clinical and regulatory risk, including uncertain trial outcomes, enrollment challenges, and manufacturing or quality issues.
• The company faces securities litigation risk and derivative actions related to prior clinical program disclosures.
• Reliance on third-party CROs and CMOs introduces supply, compliance, and operational risks.

Summary

BioVie is a clinical-stage biotech company focused on two lead programs: bezisterim (NE3107) for neurodegenerative conditions and long COVID–related cognitive symptoms, and BIV201, a continuous infusion terlipressin formulation for cirrhosis-related ascites. The company employs 13 people, maintains executive leadership, and relies on external CRO and manufacturing partners while pursuing patent protection across multiple jurisdictions. Topline clinical data through 2026 show pharmacodynamic effects and clinical endpoint signals in PD and exploratory AD analyses, but the company has no approved products and has not generated revenue to date.