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 ...