BioVie Inc. announced that a poster detailing the genetic basis for how its drug candidate NE3107 regulated specific genes in a manner significantly correlated with observed cognitive and biomarker improvements will be presented this weekend at the Alzheimer's Associate's International Conference (AAIC) to be held in Amsterdam July 16-20, 2023. In a poster presentation titled Treatment-Induced Epigenetic Modifications in MCI and Probable Alzheimer's (reading C, et al.), presenters will show how patients with clinical dementia treated with NE3107 for 3 months saw significant reductions in the level of DNA methylation, and that such reductions were significantly correlated with observed improvements in various cognitive measures (e.g., ADAS-Cog11, CDR, ADCOMS, QDRS) and biomarkers (including TNFa, CSF p-Tau/Ab42, precuneus glutathione). The new data to be presented details how NE3107 may potentially change or affect the degree of methylation of specific genes that are correlated with various markers of disease.

The Company is conducting a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer's Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer's. A Phase 2 study of NE3107 in Parkinson's disease (NCT05083260) has been completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in " morning on" symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs.

alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.