Organovo Holdings, Inc. (NYSE MKT:ONVO) Q3 2019 Earnings Conference Call - Final Transcript

Feb 07, 2019 • 05:00 pm ET


Organovo Holdings, Inc. (NYSE MKT:ONVO) Q3 2019 Earnings Conference Call - Final Transcript


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Good day and welcome to the Organovo Holdings Fiscal Third Quarter 2019 Earnings Conference Call. All participants will be in listen-only mode. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded.

I would now like to turn the conference over to Mr. Steve Kunszabo, Head of Investor Relations. Please go ahead.

Steve Kunszabo

Good afternoon, and thanks for joining us. I'd like to welcome you to our fiscal third quarter 2019 earnings call. Joining me on the call this afternoon, our CEO, Taylor Crouch; and our CFO, Craig Kussman. Today's call will begin with the discussion of the 2019 fiscal third quarter results, followed by Q&A. Before I turn things over to Taylor, I'd like to caution all participants that our call this afternoon may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts and include statements about our future expectations, plans and prospects. Such forward-looking statements are based upon our current beliefs and expectations and are subject to risks, which could cause actual results to differ from the forward-looking statements. Such risks are more fully discussed in our filings with the Securities and Exchange Commission.

Our remarks today should be considered in light of such risks. Any forward-looking statements represent our views only as of today and while we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our expectations or views change. During the call, we'll also be referring to certain supplemental financial measures. These supplemental financial measures are not prepared in accordance with generally-accepted accounting principles. Please refer to today's earnings release for definition of these supplemental financial measures.

With that, let me turn things over to Taylor.

Taylor Crouch

Thanks, Steve, and good afternoon, everyone. I'll start by noting that we are once again confirming our key clinical development and operating goals through calendar year 2020. We've also improved our cash -- net cash utilization for the 2019 fiscal year, which along with our cash on hand provides us with enough runway to meet our objectives through fiscal 2020. From an operating perspective, we're making excellent progress in executing the necessary steps for a successful IND and the start of clinical trials. This includes three additional proof-of-concept studies, dose ranging studies, and all the planning that goes along with chemistry manufacturing and control as well as good manufacturing practices preparation.

Our initial aim is to provide a bridge to transplant with our 3D bioprinted human liver tissue patches for patients with end-stage liver disease including a select group of patients with inborn errors of metabolism. By implanting our healthy tissue patch in these patients who often have limited treatment options, we want to restore function or offset the deficiencies and enzyme abnormalities related to a specific condition. Ultimately we hope to delay or reduce the overall -- for transplant in