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Frequently Asked Questions

When was Organovo founded?
Organovo, Inc. was incorporated in 2007 to advance bioprinting technology and began its operations in San Diego, California in January 2009. Read more about our history.
What is the relationship between Organovo Holdings, Inc. and Organovo, Inc.?
Organovo, Inc. has been an operating company in San Diego, California since 2009 and currently operates as a fully owned subsidiary of Organovo Holdings, Inc. As a vehicle to provide capital for Organovo, Inc.’s operations and to provide access to public markets for equity securities, Organovo, Inc. entered into a reverse merger with Organovo Holdings, Inc. in February 2012 concurrent with a private placement financing. Organovo Holdings, Inc. was a publicly traded shell company before completion of the reverse merger. Upon effectiveness of the reverse merger, former officers and directors of Organovo Holdings, Inc. resigned their positions and officers and directors associated with Organovo, Inc. assumed control of Organovo Holdings, Inc.
Who are Organovo’s customers?
Our customers span the globe including the U.S, Europe and Asia and we continue to penetrate the Top 25 global pharmaceutical companies. We also work with smaller enterprises and private venture-backed companies.
How does Organovo address critical unmet needs in pharmaceutical discovery and drug development? How do Organovo’s products and services compare to existing preclinical safety, disease modeling and efficacy solutions?
We believe our solutions enable better predictive, physiologically relevant in vitro modeling, with the potential to avoid up to $1 billion in development costs and major timeline delays for a single drug. We believe that cell models, 3D culture models and animal models do not adequately represent human biology in many cases, as evidenced by the fact that a large share of total pharma R&D spending is on drugs that fail in human trials. We address these significant gaps with our exVive3DTM Human Tissues and custom research tissues. For example, in comparison to 2D cell cultures of human liver, which is the common standard used in the industry today, our exVive3D Liver tissues last for 40+ days instead of 2 days, and demonstrates exceptional liver functional activity for that entire time. In addition, our tissues were able to detect liver toxicity for multiple products that were taken into human trials or marketed with FDA approval, and later failed. These results demonstrate that our tissue is able to detect drug-induced liver injury that existing methods often fail to predict. Organovo provides a high-content result targeted at a small number of compounds during lead selection, rather than higher throughput screening. We believe lower cost options such as 3D cell culture and spheroid methods provide a less biologically relevant result than we have demonstrated and expect to deliver to a customer, focusing instead on providing an upstream low cost high throughput option.
Does self-assembly alone create the features of Organovo’s tissues? Could the same results be achieved by simply allowing the cells to associate?
As has been discussed in publications of Organovo’s Scientific Founder, Gabor Forgacs, and in our investor presentation, while cellular self-assembly can allow formation of certain microstructures, it’s not possible for complex tissues or large architectural features to self-assemble. In Prof. Forgacs’ 2010 publication in Biofabrication, a multilayer vascular tube with smooth muscle and fibroblasts, having each layer in the 250-500 micron thickness range is demonstrated, with a distinct cell type in each layer. A mixture of those same cell types mixed 50:50 and bioprinted into a tube would not result in two layers, one of each cell type. Based on our scientific research, that architecture is impossible to achieve from self-assembly alone. In addition, our bioprinted breast cancer tumor model (investor presentation) has a 3D size and architecture that has not been obtainable by simple self-assembly, with epithelial cancer cells fully surrounded by multicellular stromal layer. In fact, as published literature shows, the natural “self-assembly” process of those same cells generally leads to the opposite structure, with the epithelial cancer cells coating the outside of the rest of the mass. If those cells were left to “self-assembly” alone, the cells at the core would be on the outside and the cells on the outside would be at the core. With our bioprinter, we can create an intact outer layer around the inside cells, forming the native tumor structure in a way superior to existing 3D tumor models. We have repeatedly demonstrated that the NovoGen MMX Bioprinter® can direct complex, defined architectures using bioprinting that are simply not attainable via self-assembly.
What published studies are there on Organovo’s scientific results?
As discussed in our press releases and SEC filings, we have conducted and intend to continue to conduct in-depth research studies. We won’t publish everything we do in our labs given the proprietary nature of our work, but we have published a significant number of these studies. Our 8-K filings and press releases have featured brief descriptions of these studies including our presentation of scientific results at various scientific and technical conferences. In addition, there are many peer-reviewed journal publications on our core technology, including one that was the most read publication of the year in 2010 in Biofabrication. We anticipate additional publications in the future. Please see Science & Technology Publications for a comprehensive list of publications and white papers on our science and technology.
Organovo has the ability to raise additional funds under its existing Form S-3s on file with the SEC. Does Organovo need capital now in order to deliver on its current operating plan?
Organovo had $70 million in cash for the period ended December 31, 2016. We believe we have sufficient capital, given our current net cash utilization rate, to deliver on our current operating plan for at least 12 months. However, we may seek to raise additional funds under certain circumstances, such as when market conditions are favorable, where we have the opportunity to accelerate execution of our current operating plan, acquire technologies or businesses, and/or where we have the opportunity to augment our current operating plan (such as to develop additional tissues not in our current plan, or build additional businesses based on our platform technology that we believe will create long-term shareholder value).
Where is Organovo located?
Our headquarters is located in San Diego, California and we have sales operations across the U.S. and in the United Kingdom.
How many employees does Organovo have?
As of December 31, 2016, we had approximately 115 full-time employees.
When did Organovo become publicly traded?
The common stock of Organovo Holdings, Inc. became publicly traded in the OTC market on February 14, 2012.
Where is Organovo traded and what is the ticker symbol?
Organovo’s common stock trades on the NASDAQ Stock Market under the ticker symbol ONVO.
What is Organovo’s CUSIP?
Our CUSIP is 68620A 10 4.
What is Organovo’s fiscal year-end? When does Organovo report earnings? How can I listen to the webcast for the earnings report?
Our fiscal year ends on March 31. Our quarters end on June 30, September 30, December 31 and March 31. We typically report earnings in connection with the filing of our Annual and Quarterly Reports (Form 10-K or Form 10-Q). In general, we are required to file a Quarterly Report on Form 10-Q within 40 days from December 31, June 30, and September 30, and an Annual Report on Form 10-K within 70 days of March 31 each year. You can find our earnings webcast in the Events and Quarterly Earnings sections of our website.
How can I receive Organovo’s annual and quarterly reports, proxy statements, earnings reports and other SEC filings?
Our annual and quarterly reports, proxy statements, earnings reports and other SEC filings are available for viewing and downloading in the SEC Filings and Quarterly Results sections of our website. These documents are also available at www.sec.gov. If you would like a hard copy of our investor kit or any of these documents, you can e-mail ir@organovo.com or fill out the request form at Contact Us.
When and where is the Organovo Annual Stockholders Meeting?
We generally hold our Annual Meeting of Stockholders in August. We will announce the date of our Annual Meeting of Stockholders in the proxy statement we provide to our stockholders and file with the SEC for the relevant year.
Can I purchase Organovo common stock directly from the Company?
No. Organovo does not have a direct stock purchase plan. You may purchase Organovo’s common stock through a registered brokerage or stock purchase service provider of your choice.
Does Organovo pay a cash dividend?
No. We have never declared or paid a cash dividend for our common stock, nor do we expect to pay any cash dividends for our common stock in the foreseeable future.
Who is Organovo’s transfer agent?
Continental Stock Transfer and Trust. They can be reached at http://www.continentalstock.com/ or 1-800-509-5586.
What is a transfer agent?
A transfer agent is a regulated organization that keeps track of registered stockholder records and information (including change of address, telephone number and name), canceling or issuing stock certificates and resolving problems related to lost, destroyed or stolen certificates. If your shares are held in street name (i.e. by your broker), you must contact your broker for these services.
Who is Organovo’s Independent Registered Public Accounting Firm?
Mayer Hoffman McCann P.C. serves as Organovo’s independent auditor.
Who is Organovo’s securities counsel?
Gunderson Dettmer, LLP serves as Organovo’s securities counsel.
Where can I find a list of Organovo’s Board of Directors?
Please see Board of Directors.
Can I tour Organovo’s facility?
Our introductory video provides representative exterior and interior views of our San Diego facility, and provides a view of our NovoGen MMX Bioprinter® in operation. The cleanroom environment in which our bioprinters operate renders tours impractical. In addition, access to our laboratories is limited to individuals with required safety and GLP training.