10-Q · May 11, 2026
BioVie Inc. continues to struggle financially with increasing net losses and no revenue generation. The company's net loss increased to $5.3 million for Q1 2026, up from $2.8 million in Q1 2025, while R&D expenses…
Earnings analysis · 10-K
BIVI earnings analysis
Filed August 13, 2026 · Our reading of the company's report
The latest report
BioVie made clinical progress, including positive SUNRISE-PD Phase 2b topline results and completion of enrollment in the ADDRESS-LC study, while continuing to pursue bezisterim across Parkinson’s disease, Alzheimer’s…
Read full summary
BioVie made clinical progress, including positive SUNRISE-PD Phase 2b topline results and completion of enrollment in the ADDRESS-LC study, while continuing to pursue bezisterim across Parkinson’s disease, Alzheimer’s disease, and Long COVID and BIV201 in advanced liver disease. However, the company remains entirely pre-revenue, with FY2026 net loss rising to $22.073 million, operating cash use of $19.025 million, and cash of $8.977 million, creating substantial financing and going-concern risk. The newly certified securities class action and the underpowered Alzheimer’s Phase 3 trial add material legal and clinical uncertainty despite the recent Parkinson’s data.
Where revenue came from
The business segments reported by the company.
Shares of the segments disclosed in this filing, largest first.
How we read each report
Our analysis across the last few reports.
Our model's reading of each filing, not the share price or the market's reaction. Annual and quarterly reports each occupy one position.
Reported figures
- Earnings per share
- $-3.05
What stood out
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Positive SUNRISE-PD Phase 2b Results
BioVie reported positive topline results from the SUNRISE-PD Phase 2b trial in August 2026. The company said bezisterim met prespecified endpoints and that treated participants showed greater improvements than placebo across daily living, motor, and nonmotor clinical measures, supporting design of a potentially pivotal Phase 3 trial.
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Two Key Clinical Programs Enrolled
The company completed enrollment in both major active Phase 2 programs: SUNRISE-PD enrolled through December 2025 and the ADDRESS-LC Long COVID study completed enrollment in May 2026. BioVie expects to report ADDRESS-LC topline results in late summer 2026.
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Multi-Indication Bezisterim Strategy
BioVie is pursuing a multi-indication strategy for bezisterim across Parkinson’s disease, Alzheimer’s disease, and Long COVID, targeting estimated U.S. populations of 1 million, 6 million, and approximately 20 million adults, respectively.
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Grant-Funded Long COVID Program
The Long COVID program is supported by a $13.1 million U.S. Department of War grant. As of June 30, 2026, the company had incurred approximately $12.9 million of program costs, and approximately $7.6 million of reimbursements were recognized against R&D expense in FY2026.
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Clinical Investment Accelerated
The company expanded clinical investment, with R&D expense increasing to $13.962 million from $9.267 million in FY2025. Clinical studies expense rose to approximately $8.177 million from $3.660 million, primarily reflecting higher SUNRISE-PD and Long COVID activity.
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Regulatory and IP Positioning
BioVie’s pipeline has differentiated regulatory and intellectual-property positioning: BIV201 has FDA Fast Track and Orphan Drug designations for ascites, while bezisterim is patented in the United States, Australia, Canada, Europe, and South Korea.
What to watch
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Certified Securities Class Action
The securities class action materially advanced during FY2026: the court granted class certification on June 18, 2026, and the defendants answered the Second Amended Complaint on June 22, 2026. The company seeks unspecified monetary damages, has not established a reserve, and its insurance has a $2 million deductible covering the first $2 million of defense costs and damages.
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Going-Concern and Funding Risk
BioVie remains pre-revenue and reported a $22.073 million net loss, $19.025 million of operating cash use, and only $8.977 million of cash and cash equivalents at June 30, 2026. Management states that these circumstances raise substantial doubt about the company’s ability to continue as a going concern and that additional financing is required.
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Underpowered Alzheimer’s Trial
The Alzheimer’s Phase 3 trial remains a significant development risk: protocol deviations and cGCP violations at 15 study sites led to patient exclusions, leaving only 81 patients in the Modified Intent-to-Treat population and 57 in the Per-Protocol population versus an original design of 125 patients in each arm. The filing states that the trial was left underpowered for its primary endpoints.
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Material Equity Dilution Overhang
Future financing could substantially dilute shareholders. At June 30, 2026, 7.542638 million common shares were outstanding, alongside 7.902037 million warrants, 2.785363 million options, and 380,000 pre-funded warrants; the company is also obligated to issue up to 180,000 additional shares upon specified milestones.
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Third-Party Clinical Execution Risk
Clinical execution depends heavily on third parties, and the company cites prior failures at 15 study sites in its Alzheimer’s trial. BioVie relies on CROs, clinical sites, investigators, laboratories, IRBs, manufacturers, and suppliers for BIV201 and bezisterim, limiting direct control over trial conduct and data quality.
Management's outlook
No annual revenue or EPS guidance is provided. The company expects to report topline results from the ADDRESS-LC Long COVID Phase 2 study in late summer 2026 and intends to use SUNRISE-PD results to inform a potentially pivotal Phase 3 trial.
Earlier filings 4
10-K · August 15, 2025
BioVie is a clinical-stage biopharmaceutical company focused on two principal programs: bezisterim (NE3107) for neurodegenerative indications and long COVID, and BIV201 (continuous-infusion terlipressin) for…
10-Q · November 13, 2024
BioVie reported a materially smaller net loss for the three months ended September 30, 2024 of $(4,152,032) (net loss attributable to common stockholders $(4,477,073), $(0.70) per share) versus $(10,710,464) and $(2.92)…
10-Q · February 13, 2024
BioVie remains a pre-revenue clinical-stage biotech with improving quarterly operating performance but clear liquidity and clinical-development risks. For the three months ended December 31, 2023 the company narrowed…
This is our reading of a public filing, not the filing itself. Analysis can contain errors; check the source document for full context.