BioVie (BIVI) Registration filing summary

Company overview and business model

• Clinical-stage company focused on developing drug therapies for neurological, neurodegenerative disorders, and advanced liver disease.

• Lead assets include bezisterim (NE3107) for Alzheimer's, Parkinson's, and Long COVID, and BIV201 (continuous infusion terlipressin) for liver cirrhosis complications.

• Bezisterim targets neuroinflammation and insulin resistance, with ongoing and completed Phase 2/3 trials in AD, PD, and Long COVID.

• BIV201 is positioned for ascites in liver cirrhosis, with FDA Fast Track and Orphan Drug designations.

Financial performance and metrics

• No revenues to date; net loss for the year ended June 30, 2025 was $17.5 million, down from $32.1 million in 2024.

• R&D expenses for the year ended June 30, 2025 were $9.3 million, a decrease from $23.1 million in 2024 due to completion of prior clinical trials.

• As of March 31, 2026, cash and cash equivalents were $13.1 million, with working capital of $15.2 million and accumulated deficit of $368.6 million.

• Company has not generated revenue and expects continued operating losses; substantial doubt exists about ability to continue as a going concern without additional financing.

Use of proceeds and capital allocation

• Estimated net proceeds from the offering are approximately $70.0 million, assuming full sale at $1.33 per share.

• Proceeds intended for working capital and general corporate purposes, including R&D, capital expenditures, and potential acquisitions.

• Management has broad discretion over use of funds; allocations may change based on business needs.