[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)

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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-35996 ORGANOVO HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (IRS Employer Identificat ...

Financial Performance - Total revenue for the three months ended December 31, 2019, was $0.3 million, a decrease of $0.5 million, or 62%, compared to the same period in 2018[119] - Total revenue for the nine months ended December 31, 2019, was $2.2 million, a decrease of $0.2 million, or 9%, compared to the same period in 2018[125] - Product and service revenues increased by 20% to approximately $2.1 million for the nine months ended December 31, 2019, driven by a $0.4 million increase in sales of primary human liver cells[125] - The company recorded other income of $1.9 million for the three months ended December 31, 2019, an increase of 1,368% compared to the prior year[118] - Other income for the nine months ended December 31, 2019, was approximately $2.6 million, a significant increase of 461% compared to $0.5 million in the prior year[129] Expenses - Research and development expenses for the three months ended December 31, 2019, were approximately $0.1 million, a decrease of $3.6 million, or 96%, from the prior year period[121] - Research and development expenses decreased by $4.9 million, or 48%, to approximately $5.4 million for the nine months ended December 31, 2019, due to a reduction in nearly all R&D activities[127] - Selling, general and administrative expenses for the three months ended December 31, 2019, were approximately $5.4 million, an increase of $2.0 million, or 59%, over the prior year period[122] - Selling, general and administrative expenses increased by $3.2 million, or 27%, to approximately $15.0 million for the nine months ended December 31, 2019, primarily due to severance costs and legal expenses related to the proposed merger[128] Merger and Acquisition - The merger with Tarveda is expected to result in Tarveda securityholders owning approximately 75% of the combined company on a fully diluted basis[111] - The merger is anticipated to be completed in the fiscal fourth quarter of 2020, subject to customary closing conditions[112] - If the net cash balance at the closing of the merger is below $22 million, the exchange ratio for Tarveda's capital stock will be adjusted to increase the number of shares issued to former Tarveda securityholders[111] - The company anticipates incurring approximately $4.2 million in transaction-related costs and $3.5 million in severance-related costs to complete the merger with Tarveda[137] Cash and Assets - As of December 31, 2019, the company had cash and cash equivalents of approximately $30.5 million and an accumulated deficit of $276.7 million[131] - The company had total current assets of approximately $31.1 million and current liabilities of approximately $2.4 million, resulting in working capital of $28.7 million as of December 31, 2019[132] - Net cash used in operating activities was approximately $11.7 million for the nine months ended December 31, 2019, a decrease from $15.3 million in the prior year[133] Stock and Equity - The 2008 Equity Incentive Plan allows for the issuance of up to 896,256 shares of common stock, while the 2012 Equity Incentive Plan permits up to 28,553,986 shares, with 6,547,442 options and 7,015,674 restricted stock units remaining outstanding as of December 31, 2019[144] - A total of 158,830,354 shares of common stock are issued and outstanding, out of the 200,000,000 shares authorized for issuance as of December 31, 2019[144] - There are 1,188,718 shares of common stock available for issuance under the 2016 Employee Stock Purchase Plan as of December 31, 2019[144] - The company has issued inducement awards for up to 3,098,473 shares of common stock under the Incentive Award Agreements[144] - The total number of shares available for issuance under the 2008 and 2012 Equity Incentive Plans and the 2016 Employee Stock Purchase Plan is 10,482,484 shares as of December 31, 2019[144] Other Information - The company has no off-balance sheet arrangements that could materially affect its financial condition or results of operations[145] - The company does not expect to receive significant proceeds from the exercise of outstanding warrants and options unless the underlying securities are registered and trading prices exceed applicable exercise prices[145] - The company has no unrecorded derivative instruments that could impact its financial condition[145] - The company is classified as a smaller reporting company and is not required to disclose quantitative and qualitative market risk[146] Staffing - The average full-time research and development staff decreased from 44 employees in the prior year to zero employees in the current year[121] - The company sold certain equipment and inventory to LifeNet for $1.5 million in cash[113] - The company sold 6,087,382 shares of common stock in at-the-market offerings, generating net proceeds of approximately $5.0 million during the nine months ended December 31, 2019[138]

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, 2019 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, 2019 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, 2019 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) (State or other jurisdiction of incorporation or organ ...

Organovo Holdings, Inc. (NASDAQ:ONVO) Q4 2019 Earnings Conference Call May 22, 2019 5:00 PM ET Company Participants Steve Kunszabo - Investor Relations Taylor Crouch - CEO Craig Kussman - CFO Conference Call Participants Ed Arce - H.C. Wainwright Matthew Cross - JonesTrading Operator Good day, and welcome to Organovo Holdings, Inc. Fiscal Fourth Quarter 2019 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now ...

Financial Data and Key Metrics Changes - The company reported a fiscal third quarter net loss of $6.4 million, a 22% improvement compared to the $7.8 million net loss in the same quarter last year [30] - Net cash utilization improved to $4 million from $6.5 million in the prior year period, attributed to a 19% reduction in total costs and expenses [30] - Cash and cash equivalents at the end of December stood at $35.2 million, including net proceeds of $1.9 million from the issuance of shares [31] Business Line Data and Key Metrics Changes - Research and development expenses were $3.8 million, a 6% year-over-year decrease due to lower employee costs [34] - Selling, general and administrative expenses were $3.4 million, a 30% year-over-year reduction primarily due to lower employee expenses [34] - Total revenue for the fiscal third quarter was $0.8 million, a 32% decline from the prior year, mainly due to lower grant revenue and fewer active contracts [36] Market Data and Key Metrics Changes - The company continues to explore opportunities in the orphan disease, pediatric disease, and regenerative medicine spaces, leveraging regulatory incentives [14] - The company is actively pursuing revenue-generating projects that utilize its 3D bioprinted technology, including custom service agreements and grants [22] Company Strategy and Development Direction - The company aims to file its first IND in calendar 2020, with several interim milestones planned, including a pre-IND meeting with the FDA [11] - The strategy includes a "basket approach" to test the capabilities of its tissue across a broad range of patients with end-stage liver disease [42] - The company is scaling up its liver tissue patches in anticipation of human dosing requirements and is advancing operational capabilities for clinical scale manufacturing [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting clinical development milestones over the next 12 to 18 months, with a focus on IND filing and preclinical studies [27] - The management highlighted the importance of healthy functioning patches to potentially signal healthier regeneration in the host liver [51] - The company remains optimistic about the potential of its liver therapeutic tissue to address a broad range of indications [15] Other Important Information - The company received its first clinical-grade liver tissue through a partnership with the International Institute for the Advancement of Medicine [21] - The company is collaborating with clients on various custom projects, including drug toxicity evaluations and liver disease modeling applications [23] Q&A Session Summary Question: Update on IND filing and basket approach - Management confirmed the basket approach is promising, focusing on patients with end-stage liver disease from various conditions [42][44] Question: Scaling up and optimization of tissue design - Management stated they are scaling up tissue patches for human use and have engaged with transplant professionals to ensure effective implementation [45][46] Question: Variability in bioprinting and NASH partnerships - Management emphasized the regenerative nature of the liver and the importance of exploring regeneration in human models [51] - They noted ongoing interest from clients in custom versions of their NASH model [55] Question: Clinical sourcing agreement with IIAM - Management explained the strategic partnership with IIAM for sourcing organs for research, enhancing their tissue design and scaling efforts [88][90]

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, 2018 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 ...