SAN DIEGO, Feb. 07, 2019 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today affirmed its key clinical development goals and reported its fiscal third-quarter 2019 financial results.
“We remain on track to submit our first IND in calendar 2020,” said Taylor J. Crouch, CEO, Organovo. “While this is our most important clinical development goal over the next two years, we’re taking a number of important steps along the way to support that milestone. In calendar 2019, we expect to hold a pre-IND meeting with the FDA on our lead program, and plan to begin our IND-enabling toxicity study. To facilitate these important objectives and to ensure our readiness for first-in-human trials, we’re conducting proof-of-concept studies in multiple disease areas, running dose ranging studies and enhancing our tissue design.”
Crouch continued, “We also continue to generate favorable preclinical results in our liver therapeutic tissue program as we focus increasingly on end-stage liver disease and a select group of inborn errors of metabolism. At industry meetings over the last several months, we’ve presented data on the performance of our tissues in animal models for Alpha-1-antitrypsin deficiency (“A1AT”) and hereditary tyrosinemia Type 1 (“HTT1”). For both rare diseases, our tissues demonstrated engraftment, retention and functionality post-implantation, while reducing disease hallmarks in the A1AT animal studies and improving the median survival rate for treated animals in the HTT1 studies. Our objective in implanting a healthy tissue patch is to restore function or offset the deficiencies related to a specific condition. We hope to serve as a ‘bridge to transplant’ for these patients with limited treatment options, with an ultimate goal of delaying or reducing the overall need for transplant.”
Crouch concluded, “We’re also building upon our cell and in vitro tissue platform, and through our partners at UC San Diego, recently presented data on the ongoing development of our non-alcoholic steatohepatitis (“NASH”) liver tissue model at the NASH-TAG 2019 Conference. Dr. David Brenner, vice chancellor for health sciences at the University of California, San Diego, presented important findings from a series of studies that showed disease induction in our 3D bioprinted liver tissue model, treatment with two clinical compounds, and a reduced disease phenotype in the treated tissues. We also continue to work with our clients on several custom projects for our liver tissue research services including the exploration of drug combination studies in our NASH disease model.”
Key Clinical Development Goals & Outlook
Fiscal Third-Quarter 2019 Highlights
Definitions & Supplemental Financial Measures
Conference Call Information
As previously announced, the Company will host a conference call to discuss its results at 5:00 p.m. ET on Thursday, February 7, 2019. Callers should dial (888) 317-6003 (U.S. only) or (412) 317-6061 (from outside the U.S.) to access the call. The conference call ID is 4962923. The conference call will also be simultaneously webcast on Organovo’s Investor Relations webpage at www.organovo.com. A replay of the conference call will be available beginning Thursday, February 7, 2019 through Thursday, February 14, 2019 at Organovo’s Investor Relations webpage. Callers can also dial (877) 344-7529 (U.S. only) or (412) 317-0088, Access Code 10127492, for an audio replay of the conference call.
About Organovo Holdings, Inc.
Organovo is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality. The Company is pursuing multiple IND-track programs to develop its NovoTissues® to address a number of serious unmet medical needs in adult and pediatric populations, initially focusing on liver disease. Organovo’s first IND-track program for Alpha-1-antitrypsin deficiency recently received orphan drug designation from the FDA, and the Company expects to file its first IND in 2020. In order to support its plan to initiate multiple IND-track programs, the Company is providing access to its ExVive™ in vitro tissue disease modeling platform to facilitate high value drug discovery and development collaborations. Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the Company and its clients with high quality human liver and kidney cells for research applications. Organovo is changing the shape of life science research and transforming medical care. Learn more at www.organovo.com.
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 benefits and therapeutic uses of the Company’s therapeutic liver tissue, including the benefits of an orphan designation; the Company’s expectations regarding the FDA regulatory pathway and anticipated timelines for its regulatory filings; the Company’s ability to successfully complete additional preclinical studies; the Company’s ability to meet market demand; and customer demand for and acceptance of its disease modeling and other in vitro tissue platforms. 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 possibility that 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; the Company may not be able to obtain sufficient raw materials to meet market demand for its therapeutic products; risks that competitive products may adversely impact the market opportunity for the Company’s therapeutic tissue candidates; 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 execute framework agreements involving multi-year commitments and routine use on a timely basis, or at all; 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 ability to raise sufficient funds to support its business plan and ongoing operations; 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; and the Company’s ability to meet its fiscal-year 2019 goals and 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 May 31, 2018. 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.
Organovo Holdings, Inc. Condensed Consolidated Balance Sheets (in thousands except for share data) December 31, 2018 March 31, 2018 (Unaudited) Assets Current Assets Cash and cash equivalents $ 35,224 $ 43,726 Accounts receivable 547 883 Grant receivable 124 145 Inventory, net 1,049 842 Prepaid expenses and other current assets 527 1,164 Total current assets 37,471 46,760 Fixed assets, net 1,946 2,788 Restricted cash 127 127 Other assets, net 141 152 Total assets $ 39,685 $ 49,827 Liabilities and Stockholders’ Equity Current Liabilities Accounts payable $ 647 $ 464 Accrued expenses 2,156 3,341 Deferred revenue 580 668 Deferred rent 27 185 Total current liabilities 3,410 4,658 Deferred revenue, net of current portion - 19 Deferred rent, net of current portion 600 564 Total liabilities 4,010 5,241 Commitments and Contingencies Stockholders’ Equity Common stock, $0.001 par value; 200,000,000 shares authorized,
Organovo Holdings, Inc. Unaudited Condensed Consolidated Statements of Cash Flows (in thousands) Nine Months Ended Nine Months Ended December 31, 2018 December 31, 2017 Cash Flows From Operating Activities Net loss $ (19,652) $ (27,354) Adjustments to reconcile net loss to net cash used in operating activities: (Gain) loss on disposal of fixed assets 63 — Depreciation and amortization 824 962 Stock-based compensation 3,911 5,600 Increase (decrease) in cash resulting from changes in: Accounts receivable 336 (527) Grants receivable 21 (260) Inventory (207) (55) Prepaid expenses and other assets 637 253 Accounts payable 183 (719) Accrued expenses (1,185) (1,293) Deferred revenue (107) 260 Deferred rent (122) (113) Net cash used in operating activities (15,298) (23,246) Cash Flows From Investing Activities Purchases of fixed assets (37) (90) Proceeds from disposals of fixed assets 3 — Purchases of intangible assets — (70) Net cash used in investing activities (34) (160) Cash Flows From Financing Activities Proceeds from issuance of common stock and exercise of warrants, net 6,916 7,243 Employee taxes paid related to net share settlement of equity awards (136) (74) Proceeds from exercise of stock options 50 826 Net cash provided by financing activities 6,830 7,995 Effect of currency exchange rate changes on cash and cash equivalents - (2) Net decrease in cash, cash equivalents, and restricted cash (8,502) (15,413) Cash, cash equivalents, and restricted cash at beginning of period 43,853 62,878 Cash, cash equivalents, and restricted cash at end of period $ 35,351 $ 47,465 Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets Cash and cash equivalents $ 35,224 $ 47,338 Restricted cash 127 127 Total cash, cash equivalent and restricted cash $ 35,351 $ 47,465 Supplemental Disclosure of Cash Flow Information: Income taxes paid $ 3 $ 23