BioVie Inc. Files 2024 10-K Report

TL;DR

BioVie filed its 2024 10-K. Check financials for FY24.

AI Summary

BioVie Inc. filed its 10-K for the fiscal year ending June 30, 2024, 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 details its business address in Carson City, NV, and provides financial data for the fiscal years 2022, 2023, and 2024.

Why It Matters

This 10-K filing provides investors and stakeholders with a comprehensive overview of BioVie Inc.'s financial health and operational performance for the fiscal year 2024, crucial for investment decisions.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, BioVie Inc. is subject to significant regulatory, clinical trial, and market risks inherent in drug development and commercialization.

Key Numbers

• FY 2024 — Fiscal Year End (Reporting period for the 10-K)
• 0630 — Fiscal Year End Date (Indicates the end of the fiscal year)
• 2023-07-01 — Fiscal Year Start Date (Beginning of the reporting period)
• 2024-06-30 — Fiscal Year End Date (End of the reporting period)
• 2022-07-01 — Prior Fiscal Year Start Date (Beginning of the previous reporting period)

Key Players & Entities

• BIOVIE INC. (company) — Filer of the 10-K
• NANOANTIBIOTICS, INC. (company) — Former name of BioVie Inc.
• 20240630 (date) — Conformed period of report
• 20240930 (date) — Filed as of date
• 775-888-3162 (phone_number) — Business phone number

FAQ

Key Financial Figures

• $0.0001 — hich registered Class A Common Stock, $0.0001 par value per share BIVI The NASDAQ S
• $13.1 million — rant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense ("D
• $12.6 million — r the Company to receive the additional $12.6 million of the aggregate $13.1 million in grant

Filing Documents

• bivi-20240630_10k.htm (10-K) — 1294KB
• bivi-20240630_10kex23z1.htm (EX-23.1) — 2KB
• bivi-20240630_10kex31z1.htm (EX-31.1) — 10KB
• bivi-20240630_10kex31z2.htm (EX-31.2) — 10KB
• bivi-20240630_10kex32z1.htm (EX-32.1) — 4KB
• bivi-20240630_10kex32z2.htm (EX-32.2) — 4KB
• image_01.jpg (GRAPHIC) — 37KB
• 0001520138-24-000324.txt ( ) — 6242KB
• bivi-20240630_lab.xml (EX-101.LAB) — 410KB
• bivi-20240630_pre.xml (EX-101.PRE) — 334KB
• bivi-20240630.xsd (EX-101.SCH) — 53KB
• bivi-20240630_cal.xml (EX-101.CAL) — 54KB
• bivi-20240630_def.xml (EX-101.DEF) — 165KB
• bivi-20240630_10k_htm.xml (XML) — 810KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 12 Item 1B. Unresolved Staff Comments 38 Item 1C. Cybersecurity 38 Item 2.

Properties

Properties 38 Item 3.

Legal Proceedings

Legal Proceedings 39 Item 4. Mine Safety Disclosures 39 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 40 Item 6. [Reserved] 40 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 40 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 44 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 44 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 44 Item 9A

Controls and Procedures

Controls and Procedures 44 Item 9B. Other Information 45 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 45 PART III Item 10. Directors, Executive Officers and Corporate Governance 46 Item 11.

Executive Compensation

Executive Compensation 46 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 46 Item 13. Certain Relationships and Related Transactions, and Director Independence 46 Item 14. Principal Accountant Fees and Services 46 PART IV Item 15. Exhibits and Financial Statement Schedules 47 Item 16. Form 10-K Summary (i) 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, 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 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. All statements other than statements of historical fact are statements that could be

forward-looking statements, except as required by law. When used in this report, the terms "BioVie", "Company",

forward-looking statements, except as required by law. When used in this report, the terms "BioVie", "Company", "we", "our", and "us" refer to BioVie, Inc. (ii) PART I ITEM 1.

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. In April 2024, the Company announced that the United States Adopted Names Council, and the World Health Organization International Nonproprietary Names expert committee had approved "bezisterim" as the non-proprietary (generic) name for NE3107. Bezisterim (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 (NE3107) could, if approved by 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 and 1 million Americans suffering from PD. In neurodegenerative disease, bezisterim (NE3107) inhibits activation of inflammatory extracellular signal-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. Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD. About Inf

View Full Filing

View this 10-K filing on SEC EDGAR