Organovo Affirms Key Clinical Development Goals; Company Reports Fiscal Third-Quarter 2019 Results
- Pre-Investigational New Drug (“IND”) meeting with the
FDAexpected to be held in calendar 2019
- Submit first IND in calendar 2020
“We remain on track to submit our first IND in calendar 2020,” said
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.
Key Clinical Development Goals & Outlook
- The Company believes that development of its healthy therapeutic liver tissue patch can treat a broad range of liver disease indications.
Organovocontinues to conduct supportive proof-of-concept studies in multiple indications aimed at treating end-stage liver disease and inborn errors of metabolism. Organovoexpects to hold a pre-IND meeting with the FDAin calendar 2019 for its lead program.
- The Company plans to begin the IND-enabling toxicity study for its lead program in the second half of calendar 2019.
Organovoexpects to file for its first IND in calendar 2020.
- The Company will continue to opportunistically generate revenue to support its therapeutic research mission by leveraging its cell and in vitro tissue platform.
Organovoplans to continue expanding its global IP portfolio, which currently includes over 100 patents and pending applications.
- As of
December 31, 2018, the Company had a cash and cash equivalents balance of $35.2 million. Organovonow expects an improved net cash utilization(1) rate of $20.5 million to $21.5 millionin fiscal 2019, and believes it has sufficient funds to meet its operating and capital requirements through fiscal 2020.
Fiscal Third-Quarter 2019 Highlights
- Net loss was
$6.4 million, a $1.4 millionimprovement over the year-ago period, as total costs and expenses declined 19 percent to $7.3 million, primarily due to lower employee costs related to the Company’s organizational restructuring and prioritization of R&D projects.
- Net cash utilization was
$4.0 million, an improvement from $6.5 millionin the prior-year quarter.
- Total revenue was
$0.8 million, a 32 percent decrease from the year-ago period, primarily driven by lower grant revenue.
- During the fiscal third quarter, the Company generated net proceeds of approximately
$1.9 millionfrom the issuance of 1.8 million shares of common stock in at-the-market offerings at a weighted average price of $1.03per share.
November 2018, the Company entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine(“IIAM”). IIAM is one of the world’s leading organizations for the procurement of organs used in medical research and the development of therapeutic applications.
Definitions & Supplemental Financial Measures
- In addition to disclosing financial results that are determined in accordance with U.S. GAAP, the Company provides net cash utilization as a supplemental measure to help investors evaluate the Company’s fundamental operational performance. The Company defines net cash utilization as the net decrease in cash and cash equivalents during the reporting period less proceeds from the sale of common stock and the exercise of warrants and stock options during the reporting period. Net cash utilization is an operational measure that should be considered as additional financial information regarding our operations. This operational measure should not be considered without also considering our results prepared in accordance with U.S. GAAP, and should not be considered as a substitute for, or superior to, our U.S. GAAP results. The Company believes net cash utilization is a relevant and useful operational measure because it provides information regarding our cash utilization rate. Management uses net cash utilization to manage the business, including in preparing its annual operating budget, financial projections and compensation plans. The Company believes that net cash utilization is also useful to investors because similar measures are frequently used by securities analysts, investors and other interested parties in their evaluation of companies in similar industries. However, there is no standardized measurement of net cash utilization, and net cash utilization as the Company presents it may not be comparable with similarly titled operational measures used by other companies. Due to these limitations, the Company’s management does not view net cash utilization in isolation but also uses other measurements, such as cash used in operating activities and revenues to measure operating performance.
Conference Call Information
As previously announced, the Company will host a conference call to discuss its results at
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
|Organovo Holdings, Inc.|
|Unaudited Condensed Consolidated Statements of Operations and Other Comprehensive Loss|
|(in thousands except share and per share data)|
|Three Months Ended||Three Months Ended||Nine Months Ended||Nine Months Ended|
|December 31, 2018||December 31, 2017||December 31, 2018||December 31, 2017|
|Products and services||$||670||$||832||$||1,709||$||2,722|
|Collaborations and licenses||43||61||128||367|
|Cost of revenues||136||192||381||747|
|Research and development expenses||3,782||4,005||10,348||13,982|
|Selling, general and administrative expenses||3,387||4,865||11,794||16,457|
|Total costs and expenses||7,305||9,062||22,523||31,186|
|Loss from Operations||(6,526||)||(7,909||)||(20,112||)||(27,688||)|
|Other Income (Expense)|
|Gain (loss) on fixed asset disposals||(65||)||—||(63||)||—|
|Total Other Income||127||118||463||334|
|Income Tax Expense||—||—||(3||)||—|
|Currency Translation Adjustment||$||—||$||(2||)||$||—||$||(2||)|
|Net loss per common share—basic and diluted||$||(0.06||)||$||(0.07||)||$||(0.17||)||$||(0.26||)|
|Weighted average shares used in computing net loss per common share—basic and diluted||116,256,561||107,345,623||113,991,794||106,107,721|
|Organovo Holdings, Inc.|
|Condensed Consolidated Balance Sheets|
|(in thousands except for share data)|
|December 31, 2018||March 31, 2018|
|Cash and cash equivalents||$||35,224||$||43,726|
|Prepaid expenses and other current assets||527||1,164|
|Total current assets||37,471||46,760|
|Fixed assets, net||1,946||2,788|
|Other assets, net||141||152|
|Liabilities and Stockholders’ Equity|
|Total current liabilities||3,410||4,658|
|Deferred revenue, net of current portion||-||19|
|Deferred rent, net of current portion||600||564|
|Commitments and Contingencies|
|Common stock, $0.001 par value; 200,000,000 shares authorized,
117,769,919 and 111,032,957 shares issued and outstanding at
December 31, 2018 and March 31, 2018, respectively
|Additional paid-in capital||289,329||278,595|
|Total stockholders’ equity||35,675||44,586|
|Total Liabilities and Stockholders’ Equity||$||39,685||$||49,827|
|Organovo Holdings, Inc.|
|Unaudited Condensed Consolidated Statements of Cash Flows|
|Nine Months Ended||Nine Months Ended|
|December 31, 2018||December 31, 2017|
|Cash Flows From Operating Activities|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|(Gain) loss on disposal of fixed assets||63||—|
|Depreciation and amortization||824||962|
|Increase (decrease) in cash resulting from changes in:|
|Prepaid expenses and other assets||637||253|
|Net cash used in operating activities||(15,298||)||(23,246||)|
|Cash Flows From Investing Activities|
|Purchases of fixed assets||(37||)||(90||)|
|Proceeds from disposals of fixed assets||3||—|
|Purchases of intangible assets||—||(70||)|
|Net cash used in investing activities||(34||)||(160||)|
|Cash Flows From Financing Activities|
|Proceeds from issuance of common stock and exercise of warrants, net||6,916||7,243|
|Employee taxes paid related to net share settlement of equity awards||(136||)||(74||)|
|Proceeds from exercise of stock options||50||826|
|Net cash provided by financing activities||6,830||7,995|
|Effect of currency exchange rate changes on cash and cash equivalents||-||(2||)|
|Net decrease in cash, cash equivalents, and restricted cash||(8,502||)||(15,413||)|
|Cash, cash equivalents, and restricted cash at beginning of period||43,853||62,878|
|Cash, cash equivalents, and restricted cash at end of period||$||35,351||$||47,465|
|Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets|
|Cash and cash equivalents||$||35,224||$||47,338|
|Total cash, cash equivalent and restricted cash||$||35,351||$||47,465|
|Supplemental Disclosure of Cash Flow Information:|
|Income taxes paid||$||3||$||23|
Investor & Press Contact:
Steve Kunszabo Organovo Holdings, Inc.+1 (858) 224-1092 firstname.lastname@example.org