BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions. 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 2 study for the treatment of refractory ascites with top-line results expected in early 2022. It is administered as a patent-pending liquid formulation. The active agent is approved in about 40 countries for related complications of advanced liver cirrhosis but is not available in the US or Japan. In neuro-degenerative disease, BioVie recently acquired the assets of NeurMedix Inc., including NE3107, an ERK inhibitor that selectively reduces neuroinflammation and insulin resistance. Both are drivers of Alzheimer’s and Parkinson’s diseases. It was recently authorized by the FDA to commence a potentially pivotal US Phase 3 clinical trial. NE3107 and related compounds are globally patented first-in-class small molecules with additional potential to treat certain cancers.

Liver Cirrhosis: BIV201 is being developed as a future treatment option for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is 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 – 12 months. The FDA has never approved any drugs to treat refractory ascites.

A Phase 2a clinical trial of BIV201 was successfully completed in 2019, and a multi-center, randomized and controlled Phase 2b trial is currently underway at prestigious medical centers including the Mayo Clinic, Vanderbilt University and University of Pennsylvania. Top-line results are expected early next year, to be followed by a single pivotal Phase 3 trial beginning in 2022.

Neurodegenerative Disease: The FDA has authorized a potentially pivotal Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer's disease (NCT04669028). An estimated six million Americans suffer from Alzheimer’s. BioVie is planning to initiate this trial in mid-2021 and targeting primary completion in late 2022. In addition to Alzheimer's disease, the Company plans to advance NE3107 in Parkinson’s based on promising results from preclinical studies. Inflammation-driven insulin resistance is implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer, which will be explored in the coming months using NE3107 or related compounds acquired from NeurMedix.

BioVie is led by a highly experienced and effective management team, including majority shareholder and Chairman Terren Peizer who has founded and successfully commercialized several healthcare companies, and CEO Cuong Do, former Chief Strategy Officer at Merck. They are complemented by an accomplished board that includes Jim Lang, CEO of Eversana; Steve Gorlin, co-founder of several highly successful biotech companies; Robert Hariri MD, PhD, CEO of Celularity, Inc.; Sig Rogich, CEO of Rogich Communications Group, Michael Sherman, former managing director at Barclays and Lehman Brothers, and Richard Berman, former Chairman of National Investment Managers.