BioVie Inc. Files 2025 10-K

TL;DR

BioVie Inc. dropped its 2025 10-K. Check financials for fiscal year ending June 30.

AI Summary

BioVie Inc. filed its 10-K for the fiscal year ending June 30, 2025, reporting on its operations and financial condition. The company, formerly known as NanoAntibiotics, Inc., is incorporated in Nevada and operates in the pharmaceutical preparations sector. The filing covers the period from July 1, 2024, to June 30, 2025, and includes financial data as of June 30, 2025, and June 30, 2024.

Why It Matters

This filing provides investors and stakeholders with a comprehensive overview of BioVie Inc.'s financial health and operational status for the past fiscal year, crucial for investment decisions.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, BioVie Inc. faces inherent risks related to drug development, regulatory approvals, and market competition, which are typically detailed in a 10-K filing.

Key Numbers

• FY 2025 — Fiscal Year End (The reporting period covered by the 10-K filing.)
• 0630 — Fiscal Year End Date (Indicates the end of the fiscal year for reporting.)

Key Players & Entities

• BIOVIE INC. (company) — Filer of the 10-K
• NANOANTIBIOTICS, INC. (company) — Former name of BioVie Inc.
• 20250630 (date) — Conformed period of report
• 20250815 (date) — Filed as of date
• 0001580149 (company) — Central Index Key for BioVie Inc.

FAQ

Key Financial Figures

• $0.0001 — hich registered Class A Common Stock, $0.0001 par value per share BIVI The NASDAQ S
• $3.7 — normous economic impact estimated to be $3.7 trillion. To date there are no non-phar
• $13.1 million — y was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense ("D
• $5 billion — ening complications, generate more than $5 billion in annual treatment costs, and have an
• $86,000 — stay lasting eight days incurring over $86,000 in medical costs. This translates into
• $650 million — arket size for BIV201 therapy exceeding $650 million based on Company estimates. The FDA ha

Filing Documents

• bivi-20250630_10k.htm (10-K) — 1136KB
• bivi-20250630_10kex3z9.htm (EX-3.9) — 73KB
• bivi-20250630_10kex19z1.htm (EX-19.1) — 34KB
• bivi-20250630_10kex23z1.htm (EX-23.1) — 2KB
• bivi-20250630_10kex31z1.htm (EX-31.1) — 10KB
• bivi-20250630_10kex31z2.htm (EX-31.2) — 10KB
• bivi-20250630_10kex32z1.htm (EX-32.1) — 4KB
• bivi-20250630_10kex32z2.htm (EX-32.2) — 4KB
• bivi-20250630_10kex97z1.htm (EX-97.1) — 32KB
• 0001520138-25-000268.txt ( ) — 5697KB
• bivi-20250630.xsd (EX-101.SCH) — 51KB
• bivi-20250630_cal.xml (EX-101.CAL) — 53KB
• bivi-20250630_def.xml (EX-101.DEF) — 179KB
• bivi-20250630_lab.xml (EX-101.LAB) — 358KB
• bivi-20250630_pre.xml (EX-101.PRE) — 290KB
• bivi-20250630_10k_htm.xml (XML) — 755KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 11 Item 1B. Unresolved Staff Comments 37 Item 1C. Cybersecurity 37 Item 2.

Properties

Properties 37 Item 3.

Legal Proceedings

Legal Proceedings 38 Item 4. Mine Safety Disclosures 38 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 39 Item 6. [Reserved] 39 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 39 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 46 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 46 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 46 Item 9A

Controls and Procedures

Controls and Procedures 46 Item 9B. Other Information 47 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 47 PART III Item 10. Directors, Executive Officers and Corporate Governance 48 Item 11.

Executive Compensation

Executive Compensation 48 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 48 Item 13. Certain Relationships and Related Transactions, and Director Independence 48 Item 14. Principal Accountant Fees and Services 48 PART IV Item 15. Exhibits and Financial Statement Schedules 49 Item 16. Form 10-K Summary BIOVIE INC.

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 as amended (the "Exchange Act"), and Section 27A of the Securities Act of 1933, as amended (the "Securities Act"). Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words "intends," "estimates," "predicts," "potential," "continues," "anticipates," "plans," "expects," "believes," "should," "could," "may," "will" or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the "Commission") that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. When used in this report, the terms "BioVie", "Compan

BUSINESS

BUSINESS Overview BioVie Inc. (the "Company" or "we" or "our") is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. Neurodegenerative Disease Program The Company acquired the biopharmaceutical assets of NeurMedix, Inc. ("NeurMedix") a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107 (or "bezisterim"). Bezisterim, the approved generic name for NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer's disease ("AD") and Parkinson's disease ("PD"), and bezisterim could, if approved by the U.S. Food and Drug Administration ("FDA"), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD , 1 million Americans suffering from PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide. In neurodegenerative disease, the Company's drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier ("BBB")-permeable, and anti-inflammatory agent that is an insulin-sensitizer. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim inhibits activation of inflammatory extracellular single regulated kinase ("ERK") and nuclear factor kappa-light-chain-enhancer of activated B cells ("NFB") (including interactions with tumor necrosis factor ("TNF") signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFB activation and TNF- productio

View Full Filing

View this 10-K filing on SEC EDGAR