BIVI News & Events

BioVie completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim on motor and non-motor symptoms in individuals with early-stage Parkinson's disease who have not been treated with carbidopa/levodopa. SUNRISE-PD explores whether bezisterim can affect the progression of Parkinson's symptoms in patients diagnosed with PD within the past four years who need treatment for their symptoms. The trial uses a hybrid, decentralized Phase 2 trial designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care. The study's flexible design allows participants to complete their study visits either at home or in a clinic, improving access and flexibility while maintaining rigorous data quality and centralized oversight

The deal priced below last closing price of $2.91. ThinkEquity is acting as sole book running manager for the offering.

BioVie presented "Bezisterim Decreases Biological Age Acceleration in Alzheimer's Disease" at the 2nd World Conference on Aging and Gerentology, WCAG-2025, in Rome, Italy July 14-15, 2025. Bezisterim modulates TNFalpha-driven inflammation and is believed to help reestablish homeostasis and small changes in many genes at the same time. An analysis of the Company's Phase 3 NM101 study evaluating bezisterim in patients with mild-to-moderate probable Alzheimer's Disease assessed 33 blood samples of patients treated with bezisterim and placebo revealed: Biological aging. After 30 weeks of treatment, bezisterim-treated patients experienced significant age deceleration compared to placebo-treated patients on all biological clocks assessed; Inflammatory gene expression. Bezisterim appeared to modulate gene expression of dozens of genes in the inflammatory cascade, resulting in reduced expression of inflammatory cytokines, including TNFalpha, IL-6, and IL-17. Aging and Alzheimer's Disease. Bezisterim appeared to have potentially beneficial modulation of many of the genes associated with aging and AD pathophysiology as identified by the National Institute on Aging's Accelerating Medicines Partnership in Alzheimer's Disease (AMP-AD) Consortium. Metabolic and inflammatory biomarkers. Bezisterim appeared to modulate many genes associated with carbohydrate metabolism, glycolysis, and Type 2 diabetes. Bezisterim-treated patients also experienced significant improvements from baseline on metabolic and inflammatory biomarkers compared to those treated with placebo.