Organovo(ONVO)

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Organovo(ONVO) - 2020 Q4 - Annual Report
2020-05-28 20:06
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 ...
Organovo(ONVO) - 2020 Q3 - Quarterly Report
2020-02-10 21:06
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]
Organovo(ONVO) - 2020 Q2 - Quarterly Report
2019-11-07 21:06
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 ...
Organovo(ONVO) - 2020 Q1 - Quarterly Report
2019-08-08 20:07
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 ...
Organovo(ONVO) - 2019 Q4 - Annual Report
2019-06-03 20:06
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(ONVO) - 2019 Q4 - Earnings Call Transcript
2019-05-23 21:05
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 ...
Organovo(ONVO) - 2019 Q3 - Earnings Call Transcript
2019-02-08 01:47
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]
Organovo(ONVO) - 2019 Q3 - Quarterly Report
2019-02-07 21:33
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 ...