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Organovo Holdings, Inc.
ORGANOVO REPORTS FISCAL FIRST-QUARTER 2019 RESULTS; COMPANY OUTLINES AND EXPANDS KEY CLINICAL DEVELOPMENT GOALS
SAN DIEGO - August 9, 2018 - 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 reported its fiscal first-quarter 2019 financial results.
"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 31st, 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."
Key Clinical Development Goals & Outlook
Fiscal First-Quarter 2019 Financial 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, August 9, 2018. 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 3834076. 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, August 9, 2018 through Thursday, August 16, 2018 at Organovo's Investor Relations webpage. Callers can also dial (877) 344-7529 (U.S. only) or (412) 317-0088, Access Code 10122205, 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.
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 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 potential market opportunity for the Company's therapeutic tissue candidates; and customer demand for and acceptance of our 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; 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 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.
Unaudited Condensed Consolidated Statements of Operations and Other Comprehensive Income (Loss)
| Three Months Ended | Three Months Ended | |||||||
| June 30, 2018 | June 30, 2017 | |||||||
| Revenues | ||||||||
| Products and services | $ | 546 | $ | 944 | ||||
| Collaborations and licenses | 43 | 46 | ||||||
| Grants | 100 | - | ||||||
| Total Revenues | 689 | 990 | ||||||
| Cost of revenues | 120 | 301 | ||||||
| Research and development expenses | 3,379 | 5,033 | ||||||
| Selling, general and administrative expenses | 4,767 | 5,856 | ||||||
| Total costs and expenses | 8,266 | 11,190 | ||||||
| Loss from Operations | (7,577 | ) | (10,200 | ) | ||||
| Other Income (Expense) | ||||||||
| Gain (loss) on fixed asset disposals | 2 | - | ||||||
| Interest income | 162 | 98 | ||||||
| Total Other Income (Expense) | 164 | 98 | ||||||
| Income Tax Expense | (3 | ) | - | |||||
| Net Loss | $ | (7,416 | ) | $ | (10,102 | ) | ||
| Currency Translation Adjustment | $ | - | $ | (11 | ) | |||
| Comprehensive Loss | $ | (7,416 | ) | $ | (10,113 | ) | ||
| Net loss per common share-basic and diluted | $ | (0.07 | ) | $ | (0.10 | ) | ||
| Weighted average shares used in computing net loss per common share-basic and diluted | 111,458,445 | 104,689,391 |
Organovo Holdings, Inc.
Consolidated Balance Sheets
| June 30, 2018 | March 31, 2018 | |||||||
| (Unaudited) | (Audited) | |||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 39,613 | $ | 43,726 | ||||
| Accounts receivable | 628 | 883 | ||||||
| Grant receivable | 100 | 145 | ||||||
| Inventory, net | 1,044 | 842 | ||||||
| Prepaid expenses and other current assets | 927 | 1,164 | ||||||
| Total current assets | 42,312 | 46,760 | ||||||
| Fixed assets, net | 2,504 | 2,788 | ||||||
| Restricted cash | 127 | 127 | ||||||
| Other assets, net | 149 | 152 | ||||||
| Total assets | $ | 45,092 | $ | 49,827 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 396 | $ | 464 | ||||
| Accrued expenses | 1,995 | 3,341 | ||||||
| Deferred revenue | 628 | 668 | ||||||
| Deferred rent | 191 | 185 | ||||||
| Total current liabilities | 3,210 | 4,658 | ||||||
| Deferred revenue, net of current portion | 10 | 19 | ||||||
| Deferred rent, net of current portion | 516 | 564 | ||||||
| Total liabilities | 3,736 | 5,241 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity | ||||||||
| Common stock, $0.001 par value; 150,000,000 shares authorized, 113,318,380 and 111,032,957 shares issued and outstanding at June 30, 2018 and March 31, 2018, respectively | 113 | 111 | ||||||
| Additional paid-in capital | 282,779 | 278,595 | ||||||
| Accumulated deficit | (241,536 | ) | (234,120 | ) | ||||
| Total stockholders' equity | 41,356 | 44,586 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 45,092 | $ | 49,827 |
Organovo Holdings, Inc.
Unaudited Consolidated Statements of Cash Flows
| Three Months Ended | Three Months Ended | |||||||
| June 30, 2018 | June 30, 2017 | |||||||
| Cash Flows From Operating Activities | ||||||||
| Net loss | $ | (7,416 | ) | $ | (10,102 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| (Gain) loss on disposal of fixed assets | (2 | ) | - | |||||
| Depreciation and amortization | 288 | 326 | ||||||
| Stock-based compensation | 1,279 | 2,052 | ||||||
| Increase (decrease) in cash resulting from changes in: | ||||||||
| Accounts receivable | 255 | (125 | ) | |||||
| Grants receivable | 45 | - | ||||||
| Inventory | (202 | ) | 89 | |||||
| Prepaid expenses and other assets | 236 | (518 | ) | |||||
| Accounts payable | (68 | ) | (613 | ) | ||||
| Accrued expenses | (1,346 | ) | (1,990 | ) | ||||
| Deferred rent | (42 | ) | (34 | ) | ||||
| Deferred revenue | (49 | ) | 262 | |||||
| Net cash used in operating activities | (7,022 | ) | (10,653 | ) | ||||
| Cash Flows From Investing Activities | ||||||||
| Purchases of fixed assets | - | (11 | ) | |||||
| Proceeds from disposals of fixed assets | 2 | - | ||||||
| Purchases of intangible assets | - | (70 | ) | |||||
| Net cash provided by investing activities | 2 | (81 | ) | |||||
| Cash Flows From Financing Activities | ||||||||
| Proceeds from issuance of common stock and exercise of warrants, net | 3,010 | 2,964 | ||||||
| Employee taxes paid related to net share settlement of equity awards | (103 | ) | (7 | ) | ||||
| Net cash provided by financing activities | 2,907 | 2,957 | ||||||
| Net increase (decrease) in cash, cash equivalents, and restricted cash | (4,113 | ) | (7,777 | ) | ||||
| Cash, cash equivalents, and restricted cash at beginning of period | 43,853 | 62,878 | ||||||
| Cash, cash equivalents, and restricted cash at end of period | $ | 39,740 | $ | 55,101 | ||||
| Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets | ||||||||
| Cash and cash equivalents | 39,613 | 54,974 | ||||||
| Restricted cash | 127 | 127 | ||||||
| Total cash, cash equivalent and restricted cash | 39,740 | 55,101 | ||||||
| Supplemental Disclosure of Cash Flow Information: | ||||||||
| Income taxes paid | $ | 3 | $ | - |