BioVie Inc. reported topline results from its Phase 2 SUNRISE-PD trial of oral bezisterim in early-stage Parkinson’s disease patients who had not received carbidopa/levodopa. The multicenter, randomized, double-blind, placebo-controlled study met prespecified endpoints focused on inflammatory biomarkers and exploratory clinical outcomes.
Patients treated with bezisterim showed statistically significant improvements versus placebo on motor and non-motor symptoms measured by MDS-UPDRS Parts I–III and the EPNIC-15 composite, as well as broad shifts in proteomic and neuroinflammatory biomarkers. Biomarker and proteomic endpoints are described as exploratory, and bezisterim’s potential impact on disease progression will require confirmation in future trials, including a potentially pivotal Phase 3 study. Bezisterim was reported to be well tolerated with an adverse event profile comparable to placebo. BioVie plans a conference call on August 12, 2026, to discuss the results.
BioVie Inc. filed a shelf registration to offer up to $300,000,000 of securities, including Class A common stock, preferred stock, warrants, debt securities, rights and units. The shelf permits multiple offerings in one or more transactions with terms to be provided in prospectus supplements.
The prospectus states Nasdaq listing under the symbol BIVI, a June 11, 2026 closing price of $1.66, and an aggregate market value of common stock held by non-affiliates of $12,542,929 as of June 8, 2026 (based on 7,292,401 non-affiliate shares at $1.72 per share). Net proceeds are intended for working capital and general corporate purposes.
BioVie Inc.'s President and CEO, Cuong Do, has filed a Schedule 13D reporting beneficial ownership of 399,018 shares of the company’s Class A common stock, representing 5.03% of the class. The filing aggregates shares, warrants and stock options held directly and through Do & Rickles Investments, LLC.
The percentage is based on 7,541,539 shares outstanding as of March 23, 2026, plus 388,119 shares issuable upon exercise of warrants and options exercisable within 60 days. The securities were acquired with personal funds and as equity compensation and are described as a long-term investment, though the reporting persons may buy or sell in the future.
BioVie Inc. is a clinical-stage biotech reporting a net loss of about $6.1M for the quarter and $11.2M for the six months ended December 31, 2025, both slightly improved versus the prior year as research and administrative costs declined.
The company ended the period with cash and cash equivalents of $20.5M, working capital of roughly $18.8M, and stockholders’ equity of about $19.3M, but its accumulated deficit reached approximately $363.3M. Management states there is substantial doubt about its ability to continue as a going concern without additional financing.
BioVie is advancing bezisterim (NE3107) for Parkinson’s disease, long COVID and Alzheimer’s disease, and BIV201 for cirrhosis and ascites. A Phase 2b Parkinson’s study completed enrollment of 60 patients with topline data expected in the first half of 2026, and a DOD-funded long COVID Phase 2 trial is underway. The Alzheimer’s Phase 3 trial was left underpowered after excluding patients from sites with protocol and cGCP issues. The company also formed Option Therapeutics for a potential spin-off of its liver program and filed an S-1 for a possible IPO.