BIOVIE INC. SEC 10-Q Report
BioVie Inc. has released its Form 10-Q report for Q3 2025, reporting a net loss of $5.1 million, an increase from the previous year. The company is advancing its neurodegenerative disease program with bezisterim, conducting clinical trials for Alzheimer's, Parkinson's, and long COVID. A Phase 2b study for Parkinson's has begun, and a $13.1 million grant has been received for long COVID research. The Phase 3 trial for Alzheimer's faced challenges but showed potential benefits. BioVie is also developing BIV201 for liver disease and is seeking additional financing for its programs.
BioVie Inc., a biopharmaceutical company focused on developing innovative therapies for liver disease and neurodegenerative disorders, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business developments during this period.
Financial Highlights
Net Loss: $5.1 million. The net loss for the three months ended September 30, 2025, increased by $0.9 million compared to the same period in 2024, primarily due to increased research and development expenses.
Net Loss Per Common Share - Basic: $(0.98). The basic net loss per common share decreased significantly from $(7.00) in the prior year period, reflecting the impact of increased shares outstanding.
Net Loss Per Common Share - Diluted: $(0.98). The diluted net loss per common share also decreased from $(7.00) in the prior year period, consistent with the basic net loss per share.
Business Highlights
Neurodegenerative Disease Program: BioVie Inc. is advancing its neurodegenerative disease program with bezisterim (NE3107), a novel small molecule targeting inflammation-driven insulin resistance. The company is conducting clinical trials for Alzheimer's disease (AD), Parkinson's disease (PD), and long COVID, aiming to address significant unmet medical needs.
Parkinson's Disease Clinical Trials: The company has initiated a new Phase 2b study of bezisterim as a potential first-line therapy for new onset PD. This trial, which began in April 2025, evaluates the safety and efficacy of bezisterim on motor and non-motor symptoms in patients who have not been treated with carbidopa/levodopa.
Long COVID Program: BioVie received a $13.1 million grant from the U.S. Department of Defense to evaluate bezisterim for treating neurological symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is underway, focusing on cognitive impairment and fatigue in long COVID patients.
Alzheimer's Disease Phase 3 Trial: The Phase 3 trial for bezisterim in mild to moderate AD faced challenges due to protocol deviations at several study sites, leading to patient exclusions. Despite being underpowered, the trial showed potential cognitive benefits and age deceleration in the Per-Protocol population.
Liver Disease Program: BioVie is developing BIV201 (continuous infusion terlipressin) for advanced liver cirrhosis complications. The company is finalizing a Phase 3 study protocol targeting a broader ascites patient population, with a focus on demonstrating clinical benefits in patients recovering from acute kidney injury.
Future Outlook: BioVie is focused on advancing its clinical programs for bezisterim and BIV201, with ongoing efforts to secure additional financing to support its development and commercialization activities. The company is exploring strategic transactions and equity sales to fund its operations.
SEC Filing: BIOVIE INC. [ BIVI ] - 10-Q - Nov. 10, 2025
