BioVie files S-1 for stock offering, discloses Phase 2b Parkinson's topline timing

BioVie Inc. filed a Form S-1 registration statement with the SEC on July 17, 2026, for a "best efforts" offering of Class A Common Stock and pre-funded warrants. The company has engaged ThinkEquity LLC to act as placement agent, which agreed to use reasonable best efforts to arrange for the sale of the securities offered.¹ The offering will terminate on September 30, 2026, unless completed sooner or the company decides to terminate it earlier.¹ BioVie's Common Stock trades on Nasdaq under "BIVI," and closed at $1.77 per share on July 15, 2026.¹

The filing details BioVie's pipeline. The company is conducting a Phase 2b trial of bezisterim as a potential first-line therapy for newly diagnosed Parkinson's disease patients, designed as a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design spanning about 20 weeks per participant.¹ The trial began in April 2025 and completed enrollment of 60 patients in December 2025, with topline results currently expected in late summer 2026, though the company said the timing could change.¹

For Alzheimer's disease, upon unblinding its Phase 3 trial data, the company found significant protocol deviations and cGCP violations at 15 study sites, leading it to exclude those patients and refer the sites to the FDA's Office of Scientific Investigations; 81 patients remained in the Modified Intent to Treat population after exclusions.¹

The filing also discloses ongoing litigation. On June 5, 2026, the court granted plaintiffs leave to amend in the consolidated securities class action, and on June 18, 2026, granted class certification subject to defendants' reservation of rights; defendants answered the amended complaint on June 22, 2026.¹