Organovo (NASDAQ: ONVO) reported Q4 EPS of ($0.07), in-line with the analyst estimate of ($0.07). Revenue for the quarter came in at $1.1 million versus the consensus estimate of $1.32 million.

“Fiscal 2018 was an important transition year for us as we demonstrated preclinical safety and efficacy proof-of-concept data for our NovoTissues® liver implant in animal models of A1AT,” said Taylor J. Crouch, CEO, Organovo. “We concluded the year by achieving orphan drug designation from the FDA for this first IND-track program and we look forward to nominating a second IND program within fiscal 2019. Our healthy liver therapeutic tissue has the opportunity to address a number of rare, serious unmet medical needs which often lead to liver transplant, and as such, we’re planning to explore additional NovoTissues indications within the spectrum of inborn errors of metabolism, acute on chronic liver failure, and other debilitating liver diseases. We estimate that the unique benefits of bridging patients to transplant or even providing a therapeutic alternative to transplant has the potential to create an addressable peak worldwide sales opportunity in excess of $4 billion. Our first target indication of A1AT alone has the potential to approach $1 billion in peak sales.”

Crouch continued, “We’ll also continue to demonstrate the robust functionality of our tissues within our in vitro testing operations, where we’re creating a series of disease conditions that can subsequently be ‘treated’ with promising new drug candidates. In fiscal 2019, we aim to expand the scope of non-alcoholic steatohepatitis (“NASH”) conditions exhibiting the key components of the disease to support high value drug discovery and development. We believe our platform represents the only comprehensive, non-clinical way to investigate key aspects of drug efficacy and safety utilizing histology, which is the gold standard of diagnosing and measuring response in NASH.”

Crouch concluded, “As we continue to demonstrate the remarkable utility of our 3D bioprinted tissues, we are focused on critical advances to medicine that our platform may provide, spanning our current support of NASH R&D through to a range of potentially breakthrough clinical applications enabled by our NovoTissues platform. We believe our technology has the potential to transform the care of patients with debilitating and often fatal liver diseases.”

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