BioVie Inc. issued the following letter to shareholders that the company has made tremendous progress since last wrote in December, and the totality of the data have shared lead to be increasingly excited and optimistic about what hope to see when Phase 3 trial for NE3107 in Alzheimer's Disease (AD) reads out later this year. The company has prepared this letter to shareholders to provide an update that synthesizes all the information that have released and presented at recent medical conferences. 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 probable Alzheimer's disease (NCT04669028).

Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker lev els 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 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. patients treated with levodopa alone, and no drug-related adverse events.

In liver disease, the Company's Orphan drug candidate BV201 (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. BV201 is administered as a patent-pending liquid formulation. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.