ONVO Organovo Holdings Inc

Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today announced that it will present new preclinical data showing the strong functionality of its liver therapeutic tissue in a second IND-track program for Type 1 Tyrosinemia.  This data will be presented at the World Advanced Therapies and Regenerative Medicine Congress in London on May 18, 2018 by Benjamin Shepherd, Ph.D., Senior Director of Therapeutics, at Organovo.

Type 1 Tyrosinemia is a rare disease characterized by a patient’s inability to metabolize the amino acid tyrosine due to a deficiency of the enzyme fumarylacetoacetate hydrolase.  This disorder frequently causes severe liver damage, with current treatment options often limited to organ transplantation.  Organovo recently studied the potential benefit of its NovoTissues® in an established animal model for Type 1 Tyrosinemia, and showed retention and sustained functionality post-implamantation.  Pathologic evaluation of the diseased animals receiving implanted bioprinted liver tissues also suggested an improvement in liver health and extended survival versus non-treated animals.

The Company will also summarize its ongoing progress in its first IND-track program for its NovoTissues treatment of alpha-1 antitrypsin deficiency (“A1AT”).  This indication, which received orphan drug designation from the U.S. Food & Drug Administration in 2017, similarly represents a patient population that is in desperate need of new treatment options.  Organovo previously disclosed the results of its preclinical studies in an established animal model for A1AT.  Serum and histopathologic evaluation of the implanted therapeutic tissue showed engraftment, retention and a high degree of disease clearing through 125 days post-implantation.  These results also demonstrated the sustained presence of key human liver proteins such as albumin and A1AT in the animal bloodstream.  Importantly, pathologic evaluation of diseased animals receiving implanted bioprinted liver tissues suggested a significant reduction in the pathologic hallmarks of the disease in the damaged region of the liver adjacent to the NovoTissues transplant.

“We’re encouraged that our 3D bioprinted liver tissues continue to show retention and functionality in a range of animal disease models, including two disease areas where there is critical unmet need and a significant impact on patient outcomes because of the dire shortage of liver transplants,” said Dr. Benjamin Shepherd, senior director of therapeutics, Organovo.  “In each case, our objective in implanting a healthy tissue patch is to restore function or offset the deficiency of a specific enzyme abnormality, with the ultimate goal of delaying or reducing the need for a transplant.”   

“We are delighted with the early readouts of these complementary therapeutics programs,” said Taylor J. Crouch, CEO, Organovo.  “The results in this second disease area within the orphan group of inborn errors of metabolism support the opportunity for a synergistic, second IND-track that we will likely pursue alongside our lead IND-track program for A1AT deficiency.  There is great utility in deploying a single implanted tissue to treat multiple diseases, all of which are life-threatening and have few alternative treatment options.”

About Organovo Holdings, Inc.Organovo is developing and commercializing a platform technology to produce and study living tissues that emulate key aspects of human biology and disease for use in drug discovery, clinical development, and therapeutic applications.  The Company develops tissue systems through internal research programs and in collaboration with pharmaceutical, academic and other partners.  Organovo's living tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization.  The Company’s ExViveTM Liver and Kidney Tissues are used in disease modeling for NASH and fibrosis, high-value drug profiling, target and marker discovery/validation, and other drug testing.  The Company is also advancing a preclinical program to develop its NovoTissues® liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases.  The Company has received orphan designation for its potential treatment of alpha-1-antityrpsin deficiency, its lead indication within the category of inborn errors of metabolism.  Organovo is changing the shape of life science research and transforming medical care.  Learn more at www.organovo.com.

Forward-Looking Statements Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties.  Forward-looking statements include, but are not limited to, statements regarding the potential for one or more customer’s electing to move toward framework agreements involving annual budgets, revenue commitments, and/or dedicated research plans, the expected costs, timing and operational benefits of the Company’s restructuring plan, the financial impact of the Company’s restructuring plan on its future operating costs and financial results, and statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue.  The factors that could cause the Company's actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company's products, services and technology; the Company’s ability to successfully complete studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; the Company’s ability to recognize deferred revenue; the final results of the Company's preclinical studies may be different from the Company's studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; and the Company’s ability to meet its fiscal year 2018 outlook. These and other factors are identified and described in more detail in the Company's filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 7, 2017. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

Investor & Press Contact:

Steve KunszaboOrganovo Holdings, Inc.+1 (858) 224-1092skunszabo@organovo.com