Organovo Reports Fiscal First-Quarter 2019 Results; Company Outlines and Expands Key Clinical Development Goals

Organovo (NASDAQ:ONVO) a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today reported its fiscal first-quarter 2019 financial results.

As quoted in the press release:

“During the fiscal first quarter, we refined our operating and scientific goals,” said Taylor J. Crouch, CEO, Organovo.  “We have concentrated our financial resources around supporting our healthy liver therapeutic tissue development, which has the potential to address a number of serious unmet medical needs, encompassing an addressable peak worldwide sales opportunity greater than $4 billion.”

Crouch continued, “On July 31^st, we held a pre-pre-IND meeting with the FDA to review our IND planning for our lead program in A1AT.  In light of this meeting’s outcome, we intend to submit our pre-IND meeting package to the FDA in calendar 2019.  Based on anticipated study designs for our IND-enabling work, we continue to target calendar 2020 for filing our IND, with the possibility of commencing human trials that same year.”

Crouch concluded, “We’ll also continue to opportunistically generate revenue to support our therapeutics program by leveraging our cell and in vitro tissue platform including providing funded access to our developmental non-alcoholic steatohepatitis (“NASH”) platform to clients for their own R&D programs.”

Click here to read the full press release.