Organovo Holdings, Inc. (NYSE MKT:ONVO) Q2 2019 Earnings Conference Call Transcript

Nov 08, 2018 • 05:00 pm ET

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Organovo Holdings, Inc. (NYSE MKT:ONVO) Q2 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good afternoon, and welcome to the Organovo Holdings, Inc. Fiscal Second Quarter 2019 Earnings Conference Call. (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 Steve Kunszabo, Head of IR. Please go ahead.

Executive
Steve Kunszabo

Good afternoon, and thanks for joining us. I would like to welcome you to our fiscal second quarter 2019 earnings call. Joining me on the call this afternoon, our CEO, Taylor Crouch; our CFO, Craig Kussman; and our Chief Medical Officer, Steven Hughes. Today's call will begin with the discussion of the 2019 fiscal second quarter results, followed by Q&A.

(Forward-Looking Cautionary Statements)

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.

Executive
Taylor Crouch

Thanks, Steve, and good afternoon, everyone. I'll begin by highlighting that we're on track to achieve the key clinical development and operating goals that we've outlined through calendar 2020. We're moving ahead with additional relevant pre-clinical studies to broaden our proof-of-concept data across the range of disease conditions. We're also engaging with trusted advisers expertise in liver disease, surgical techniques and regenerative medicine regulatory strategies to fine-tune our fastest-effective path to the clinic.

Our aim is clear, treating a spectrum of pediatric and adult liver diseases with our 3D bioprinted human liver tissue patches. We are targeting rare and often life-threatening conditions, which currently have limited treatment options and the shortage of organs available for full liver transplants leaves many patients in desperate need of new potential therapies. To start, we focused on animal models of single mutation inborn errors of metabolism, including Alpha-1-antitrypsin deficiency, A1AT, and Type 1 Tyrosinemia. Our objective in implanting a healthy tissue is to restore function or offset the deficiency of a specific enzyme abnormality. Ultimately, by conducting successful future studies, we also hope to show that our liver therapeutic tissue would delay or reduce the need for a transplant.

As I look ahead to our planned first IND filing in calendar 2020, there are several interim milestones along the way to map our progress. We believe that our development of a healthy therapeutic liver tissue patch can create -- can treat a broad range of rare disease indications. To that end, we're pursuing a second orphan drug designation with the FDA. We expect news on this additional orphan designation in the first half of calendar 2019. We also expect to hold a pre-IND meeting with the FDA in calendar 2019 to focus on the final steps that enable human clinical trials in A1AT patients and others awaiting transplant.

And finally, we intend to start our IND-enabling toxicity study to support multiple indications, including Alpha-1-antitrypsin deficiency in the second half of calendar 2019. In addition, we will continue to conduct