UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR | Title of each class | Trading symbol | Name of Each Exchange on which registered | | --- | --- | --- | | Common Stock, $0.001 par value | ONVO | The Nasdaq Stock Market LLC | Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File No. 001-35996 ORGANOVO HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of in ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of incor ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File No. 001-35996 ORGANOVO HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of in ...

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2020 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35996 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of ...

[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%2E%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Organovo reported zero revenue and a **$2.8 million** net loss for Q2 2020, reflecting suspended operations and a strategic pivot towards a new drug discovery model Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | March 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $24,787 | $27,356 | | Total current assets | $25,501 | $28,318 | | Total assets | $25,621 | $28,441 | | Total current liabilities | $835 | $1,810 | | Total stockholders' equity | $24,786 | $26,631 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | | :--- | :--- | :--- | | Total Revenues | $0 | $668 | | Total costs and expenses | $2,786 | $7,189 | | Loss from Operations | $(2,786) | $(6,521) | | Net Loss | $(2,769) | $(6,323) | | Net loss per common share | $(0.02) | $(0.05) | Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,570) | $(5,935) | | Net cash provided by investing activities | $2 | $1 | | Net cash provided by (used in) financing activities | $(1) | $4,944 | | Net decrease in cash | $(2,569) | $(990) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the August 2019 program suspension, terminated Tarveda merger, and a July 2020 agreement proposing a new board and drug discovery focus, requiring future capital - In August 2019, the company suspended its lead liver therapeutic tissue program due to performance variability and extended timelines[22](index=22&type=chunk) - The proposed merger with Tarveda Therapeutics was terminated in April 2020 due to lack of stockholder approval[25](index=25&type=chunk) - On July 14, 2020, a Cooperation Agreement with Keith Murphy proposed a new board and a drug discovery business plan using 3D human tissues[26](index=26&type=chunk)[28](index=28&type=chunk) - New board approval would trigger a Change of Control, requiring approximately **$3.0 million** for severance and **$2.0 million** for D&O tail insurance[39](index=39&type=chunk)[101](index=101&type=chunk) - The company is cooperating with an SEC inquiry initiated in March 2020 concerning prior disclosures and operations[89](index=89&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes revenue and R&D declines to strategic halts, with cash decreasing by **$2.6 million**; additional capital is needed if the new drug discovery plan is approved [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Total revenues fell to zero and R&D expenses were eliminated due to strategic cessation of activities, while SG&A decreased by **16%** due to restructuring Comparison of Results of Operations (in thousands) | Line Item | Q2 2020 | Q2 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $668 | $(668) | (100%) | | Research and development | $0 | $3,823 | $(3,823) | (100%) | | Selling, general and administrative | $2,786 | $3,315 | $(529) | (16%) | - The **100%** decrease in R&D expenses resulted from eliminating all R&D activities, reducing personnel, lab supply, and facilities costs[125](index=125&type=chunk) [Financial Condition, Liquidity and Capital Resources](index=23&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) As of June 30, 2020, Organovo held **$24.8 million** in cash, with net cash used in operations at **$2.6 million**, but additional capital is needed for the new business plan - The company held approximately **$24.8 million** in cash and cash equivalents as of June 30, 2020[129](index=129&type=chunk) - Current cash is sufficient for the next 12 months, but additional capital will be required if the new drug discovery operations commence[136](index=136&type=chunk) - The company faces Nasdaq delisting for failing to maintain a **$1.00** minimum bid price and plans a reverse stock split to regain compliance by September 4, 2020[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Disclosure is not required for smaller reporting companies under Item 305(e) - Disclosure is not required for smaller reporting companies under Item 305(e)[143](index=143&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2020, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective as of the end of the quarterly period[145](index=145&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II%2E%20OTHER%20INFORMATION) [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is cooperating with an SEC inquiry from March 2020 and considers a January 2020 stockholder demand letter regarding S-4 disclosures moot and without merit - The company received an SEC inquiry letter on March 4, 2020, regarding prior disclosures and operations, and is cooperating with a subpoena[89](index=89&type=chunk) - A January 2020 stockholder demand letter regarding Form S-4 disclosures for the terminated Tarveda merger is considered moot and without merit[88](index=88&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from COVID-19, an unproven new business strategy requiring significant funding, historical program failures, operational challenges including potential dissolution, and intellectual property protection concerns [Risks Related to COVID-19](index=27&type=section&id=Risks%20Related%20to%20COVID-19) The COVID-19 pandemic introduces significant uncertainty, potentially impacting strategic alternatives, R&D advancement, and partner operations, with ultimate effects highly uncertain - The COVID-19 pandemic could adversely impact operations, strategic alternatives, and R&D advancement[152](index=152&type=chunk) [Risks Related to the Proposed Go Forward Business](index=27&type=section&id=Risks%20Related%20to%20the%20Proposed%20Go%20Forward%20Business) The proposed new business plan entails restarting as an early-stage company with an unproven drug discovery strategy, requiring substantial funding, key personnel, and new facilities amidst intense competition - Approval of the new business plan means recommencing as an early-stage company with an unproven strategy, potentially never achieving profitability[155](index=155&type=chunk)[156](index=156&type=chunk) - Substantial additional funding is required for the proposed business plan, which would dilute existing stockholders[167](index=167&type=chunk) - The new business plan necessitates hiring key scientific personnel, securing lab facilities, and establishing a reliable human cell supply[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) [Risks Related to our Historical Business](index=31&type=section&id=Risks%20Related%20to%20our%20Historical%20Business) Historical business risks include significant setbacks in developing bioprinted therapeutic tissues, particularly the liver candidate, due to performance variability, manufacturing issues, and technical challenges - Liver tissue candidate development was halted due to variability in biological performance and questions regarding durability and functionality[183](index=183&type=chunk) - Manufacturing issues, including technical and quality problems, contributed to the failure and cessation of the liver tissue candidate's development[184](index=184&type=chunk)[187](index=187&type=chunk) [Risks Related to Our Capital Requirements, Finances and Operations](index=37&type=section&id=Risks%20Related%20to%20Our%20Capital%20Requirements%2C%20Finances%20and%20Operations) Significant financial and operational risks include potential dissolution if a new strategy fails, a history of **$282.3 million** in accumulated losses, and challenges in retaining key personnel amidst a potential change of control - If the Advisory Proposal is not approved, the board may pursue dissolution and liquidation, with no assurance of cash distribution to stockholders[206](index=206&type=chunk) - The company has a history of operating losses, with a cumulative net loss of **$282.3 million** as of June 30, 2020, and anticipates further losses[212](index=212&type=chunk) [Risks Related to Our Common Stock and Liquidity Risks](index=39&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock%20and%20Liquidity%20Risks) Common stock faces Nasdaq delisting due to minimum bid price failure, with a planned reverse split; concentrated shareholder influence and high stock price volatility are also key risks - The company risks Nasdaq delisting for failing to meet the **$1** minimum bid price and plans a reverse stock split to regain compliance by September 4, 2020[216](index=216&type=chunk)[217](index=217&type=chunk) - The two largest shareholders, ARK Investment Management and Nikko Asset Management, collectively own approximately **30%** of outstanding stock, exerting significant influence[222](index=222&type=chunk) [Risks Related to Our Intellectual Property](index=42&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Intellectual property risks include challenges in obtaining and enforcing patents, potential for insufficient patent breadth, and dependence on crucial license agreements with universities, non-compliance with which could harm the business - Success depends on obtaining and maintaining adequate patent protection, though validity, enforceability, or breadth are not guaranteed[232](index=232&type=chunk)[235](index=235&type=chunk) - Crucial license agreements with the University of Missouri, Clemson, and UniQuest are vital, and their breach or termination could materially harm the business[245](index=245&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds to report - None[246](index=246&type=chunk) [Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities to report - None[247](index=247&type=chunk) [Mine Safety Disclosure](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) Mine safety disclosure is not applicable to the company's operations - Not applicable[248](index=248&type=chunk) [Other Information](index=44&type=section&id=Item%205.%20Other%20Information) No other information to report - None[249](index=249&type=chunk) [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including the terminated Tarveda Merger Agreement, the Cooperation Agreement with Keith Murphy, and officer/director certifications - Key exhibits include the terminated Merger Agreement with Tarveda Therapeutics, the Cooperation Agreement with Keith Murphy, and CEO/CFO certifications[251](index=251&type=chunk)