Business Context and Reporting Period
Company: BIOVIE INC. (BIVI)
Filing Type: Form 10-K (Annual Report)
Period Ended: June 30, 2026
Business Overview: BioVie is a clinical-stage biopharmaceutical company developing therapies for neurological/neurodegenerative disorders (Alzheimer's, Parkinson's, Long COVID) and advanced liver disease. The company has no approved products and has never generated revenue.
Key Financial Metrics
| Metric | Year Ended June 30, 2026 | Year Ended June 30, 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(22.1) million | $(17.5) million |
| Operating Expenses | $22.7 million | $18.1 million |
| Research & Development (R&D) | $14.0 million | $9.3 million |
| General & Administrative (G&A) | $8.5 million | $8.6 million |
| Cash and Cash Equivalents | $9.0 million | $17.5 million |
| Working Capital | $9.8 million | $18.4 million |
| Accumulated Deficit | $(374.3) million | $(352.1) million |
| Net Cash Used in Operating Activities | $(19.0) million | $(19.0) million |
Material Changes vs. Prior Period
- Increased Net Loss: Net loss increased by $4.6 million (26%) primarily due to a $4.7 million increase in R&D expenses.
- R&D Expense Drivers: The increase in R&D was driven by the completion of enrollment for the SUNRISE-PD Phase 2b study (Parkinson's) and the ADDRESS-LC Phase 2 study (Long COVID). Direct study costs increased by approximately $4.5 million.
- Grant Reimbursements: The company recognized $7.6 million in grant reimbursements from the U.S. Department of War (formerly Department of Defense) for the Long COVID study, offsetting a portion of the R&D spend.
- Capital Raise: In August 2025, the company closed an underwritten public offering raising approximately $10.5 million in net proceeds, which contributed to the cash balance at period end.
- Debt Repayment: The company paid off a $15 million loan commitment in December 2024, resulting in reduced interest expense in the current period.
Guidance, Outlook, Risks, and Unusual Items
Clinical Program Updates
- Parkinson's Disease (Bezisterim): In August 2026, the company announced positive topline results from the Phase 2b SUNRISE-PD trial. The study met its primary pharmacodynamic endpoint, showing a statistically significant reduction in neuroinflammation markers. The company plans to design a pivotal Phase 3 trial based on these results.
- Long COVID (Bezisterim): The Phase 2 ADDRESS-LC study completed enrollment in May 2026. Topline results are expected in late summer 2026.
- Alzheimer's Disease (Bezisterim): A previous Phase 3 trial was underpowered due to significant protocol deviations and cGCP violations at 15 study sites, leading to the exclusion of many patients. While the trial did not meet primary endpoints, exploratory data suggested a slowing of cognitive decline in the per-protocol population.
- Liver Cirrhosis (BIV201): The company is finalizing the protocol for a Phase 3 study of continuous infusion terlipressin for ascites, focusing on patients who recently recovered from acute kidney injury.
Risks and Contingencies
- Going Concern: The filing includes a "substantial doubt" warning regarding the company's ability to continue as a going concern due to recurring losses and negative cash flows. Future operations depend on securing additional financing.
- Legal Proceedings: The company is subject to a consolidated securities class action lawsuit (In re BioVie Inc. Securities Litigation) alleging misrepresentations regarding the Phase 3 Alzheimer's trial. The class was certified in June 2026. Additionally, three shareholder derivative lawsuits have been consolidated and stayed pending the resolution of the class action. The company has a $2 million deductible on its insurance coverage for these matters.
- Liquidity: As of June 30, 2026, cash and cash equivalents were $9.0 million. Management expects to raise additional capital through equity sales or loans to fund operations.
Investor Verification Checklist
- Cash Runway: Verify the current cash balance and burn rate to assess the timeline for the next capital raise, given the "substantial doubt" disclosure.
- Legal Exposure: Monitor the status of the certified securities class action and derivative lawsuits, specifically the potential liability exceeding the $2 million insurance deductible.
- Clinical Milestones: Track the release of the Long COVID (ADDRESS-LC) topline results expected in late summer 2026 and the design of the Parkinson's Phase 3 trial.
- Grant Funding: Confirm the status of the $13.1 million DOD grant for the Long COVID study and the timing of future reimbursements.
- Dilution Risk: Review the outstanding warrants (approx. 8.3 million shares) and options (approx. 2.8 million shares) which could significantly dilute existing shareholders upon exercise.