Organovo Holdings Files 2024 10-K

TL;DR

Organovo Holdings filed its 2024 10-K. Financials and R&D segment details inside.

AI Summary

Organovo Holdings, Inc. filed its 10-K for the fiscal year ending March 31, 2024. The company, formerly known as Real Estate Restoration & Rental, Inc., is focused on biological products. Key dates mentioned include the filing date of May 31, 2024, and the fiscal year end of March 31, 2024. The filing details various financial instruments and segment information, including a Research & Development segment.

Why It Matters

This filing provides a comprehensive overview of Organovo Holdings' financial health and operational status for the past fiscal year, crucial for investors and stakeholders to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — As a company in the biological products sector, Organovo Holdings likely faces inherent risks related to research, development, regulatory approvals, and market adoption.

Key Numbers

• 0331 — Fiscal Year End (Indicates the end of the reporting period for financial statements.)
• 20240531 — Filing Date (The date the 10-K was officially submitted to the SEC.)

Key Players & Entities

• ORGANOVO HOLDINGS, INC. (company) — Filer
• REAL ESTATE RESTORATION & RENTAL, INC. (company) — Former Company Name
• 20240331 (date) — Fiscal Year End
• 20240531 (date) — Filing Date
• SAN DIEGO, CA (location) — Business Address
• Clemson University (company) — Collaboration/Licensing Mention
• Salk Institute for Biological Studies (company) — Collaboration/Licensing Mention

FAQ

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share ONVO The Nasdaq Capital M
• $0.80 — at a combined public offering price of $0.80 per share and accompanying Common Warra
• $0.799 — at a combined public offering price of $0.799 per Pre-Funded Warrant and accompanying
• $0 — se price for the Pre-Funded Warrants is $0.001, subject to adjustment as provided
• $4.7 million — received net proceeds of approximately $4.7 million from the Offering, after deducting the

Filing Documents

• onvo-20240331.htm (10-K) — 1866KB
• onvo-ex4_3.htm (EX-4.3) — 45KB
• onvo-ex21_1.htm (EX-21.1) — 3KB
• onvo-ex23_1.htm (EX-23.1) — 4KB
• onvo-ex23_2.htm (EX-23.2) — 4KB
• onvo-ex31_1.htm (EX-31.1) — 12KB
• onvo-ex31_2.htm (EX-31.2) — 12KB
• onvo-ex32_1.htm (EX-32.1) — 9KB
• onvo-ex97.htm (EX-97) — 54KB
• img64643574_0.jpg (GRAPHIC) — 170KB
• 0000950170-24-067301.txt ( ) — 8912KB
• onvo-20240331.xsd (EX-101.SCH) — 1422KB
• onvo-20240331_htm.xml (XML) — 1270KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 7 Item 1B. Unresolved Staff Comments 27 Item 1C. Cybersecurity 27 Item 2.

Properties

Properties 27 Item 3.

Legal Proceedings

Legal Proceedings 27 Item 4. Mine Safety Disclosures 28 PART II 29 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 29 Item 6. [Reserved] 30 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 31 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 36 Item 8. Consolidated Financial Statements F- 1 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 37 Item 9A.

Controls and Procedures

Controls and Procedures 37 Item 9B. Other Information 37 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 38 PART III 39 Item 10. Directors, Executive Officers and Corporate Governance 39 Item 11.

Executive Compensation

Executive Compensation 39 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 39 Item 13. Certain Relationships and Related Transactions, and Director Independence 39 Item 14. Principal Accountant Fees and Services 39 PART IV 40 Item 15. Exhibits and Financial Statement Schedules 40 Important Information Regardi ng Forward-Looking Statements Portions of this Annual Report on Form 10-K (including information incorporated by reference) ("Annual Report") include "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, based on our current beliefs, expectations and projections regarding any strategic transaction process; the ability to advance our research and development activities and pursue development of any of our pipeline products; our technology; our product and service development opportunities and timelines; our business strategies; customer acceptance and the market potential of our technology; products and services; our future capital requirements; our future financial performance; and other matters. This includes, in particular, Item 1. "Business" and Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of this Annual Report, as well as other portions of this Annual Report. The words "believe," "expect," "anticipate," "project," "could," "would," and similar expressions, among others, generally identify "forward-looking statements," which speak only as of the date the statements were made. The matters discussed in these forward-looking statements are subject to risks, uncertainties and other factors that could cause our actual results to differ materially from those projected, anticipated or implied in the forward-looking statements. As a result, you should not place undue reliance on any forward-looking statements. The most significant of these risks, uncertainties and other facto

Bu siness

Item 1. Bu siness. Overview Organovo Holdings, Inc. ("Organovo," "we," "us," "our," the "Company" and "our Company") is a clinical stage biotechnology company that is focused on developing FXR314 in inflammatory bowel disease ("IBD"), including ulcerative colitis ("UC"), based on demonstration of clinical promise in three-dimensional ("3D") human tissues as well as strong preclinical data. FXR is a mediator of gastrointestinal and liver diseases. FXR agonism has been tested in a variety of preclinical models of IBD. FXR314 is the lead compound in our established FXR program containing two clinically tested compounds (including FXR314) and over 2,000 discovery or preclinical compounds. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in UC. Our current clinical focus is in advancing FXR314 in IBD, including UC and Crohn's disease ("CD"). We plan to start a Phase 2a clinical trial in UC in the calendar year 2024. We released Phase 2 data for FXR314 for the treatment of metabolic function-associated steatohepatitis ("MASH") in April 2024 that are supportive of ongoing development, and we believe FXR314 has a commercial opportunity in MASH, most likely in combination therapy. We are exploring the potential for combination therapies using FXR314 and currently approved mechanisms in preclinical animal studies and our IBD disease models. Our second focus is building high fidelity, 3D tissues that recapitulate key aspects of human disease. We use our proprietary technology to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. We believe these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs across multiple therapeutic areas. As with the clinical development program, we are initially focusin

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