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Organovo on Track to Commercialize Kidney Tissue; Company Signs First Customer Orders for Kidney Tissue Early Access Program
SAN DIEGO, July 20, 2016 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NYSE:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today announced that it is on track to commercialize its second tissue, the kidney proximal tubule, in the third calendar quarter of 2016. As part of its pre-commercialization activities, Organovo introduced an early access program for preferred partners and has signed the first customer orders to study the effects of drug exposure on the kidney proximal tubule. The Company has also actively engaged with additional biopharmaceutical companies, indicating strong interest in this program and its kidney tissue.
“The power and versatility of our technology platform allows us to create multiple tissues that address a number of different customer needs,” said Paul Gallant, general manager of commercial operations, Organovo. “Kidney is a natural expansion of our preclinical product and service portfolio, providing a better solution than traditional in vitro models for drug research. Our initial customers are using the kidney model to study key aspects of kidney pharmacology, including compound transport, metabolism and toxicity.”
Gallant continued, “With a robust sales footprint in place, and our ability to leverage the strong relationships we’ve built with core customers in the liver toxicology business, we’re confident that we’ve positioned ourselves for early success with the kidney tissue. We look forward to bringing this groundbreaking product to market in the coming months.”
Organovo Announces Release Date for Fiscal First-Quarter 2017 Financial Results
SAN DIEGO, July 14, 2016 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NYSE MKT:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, will host a conference call on Thursday, August 4, 2016 at 5:00 p.m. Eastern Time (ET) to discuss the Company's fiscal first-quarter 2017 financial results. In advance of the call on August 4, 2016, Organovo will issue its fiscal first-quarter 2017 earnings press release, which will be available at http://www.organovo.com. To participate in the teleconference, callers can dial the following numbers:
1-888-317-6003 (toll-free, U.S. callers only)
1-412-317-6061 (from outside the U.S.)
Conference Call ID: 2415344
To help ensure the conference call begins in a timely manner, please dial in five minutes prior to the scheduled start time. The conference call will also be simultaneously webcast at http://www.organovo.com.
For those unable to participate in the live call, a replay of the call will be available toll-free until August 11, 2016 at 1-877-344-7529 (U.S. callers only) or at 1-412-317-0088 (callers outside the U.S.). The passcode for the replay is: 2415344. An archived replay of the webcast will also be available at http://www.organovo.com.
Getting some good play on SA: Organovo's 3D liver tissues beats traditional preclinical tests in detecting dose-dependent toxicity of withdrawn antibiotic trovafloxacin; shares up 10% premarket
http://www.seekingalpha.com/news/3192475
Up on a down day with good volume! I like it!
Nice! Here's another YouTube video: http://organovo.com/webinar/. I listened into this webinar yesterday. A lot of geek spread, but still very impressive with just the right amount of marketing.
I'd like to see those numbers within 2 weeks, before my $4 options expire.
My bad! I should have read the entire article. It is basically a Motley Fool marketing tool.
New positive Motley Fool article out this morning: http://www.fool.com/investing/2016/06/30/why-organovo-holdings-inc-is-up-27-this-year.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2
The webinar is today at Noon EDT.
Register for Organovo's Live WebInar on the Use of Bioprinted 3D Human Tissues for the Assessment of Drug Toxicity to be presented by Sharon Pressnel, Ph.D., at https://attendee.gotowebinar.com/register/3575161389014318081?splash=false.
There are a lot of shares trading hands today.
Over $1MIL in shares purchased after the close! That's a very good sign to me given all that is going on with BREXIT.
I saw that ~210K shares traded for $680K at the open today. Wow!!!
Unfortunately the news about the collaboration with USCF is not being picked up by the major news feeds. For example, it's not showing up within my Schwab account.
Organovo Collaborates With UCSF Team to Develop 3D Bioprinted Tissues for Skeletal Disease Research
SAN DIEGO, SAN FRANCISCO and SPRINGFIELD, Va., June 13, 2016 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NYSE MKT:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today announced a collaboration with the University of California, San Francisco (“UCSF”) to develop 3D bioprinted tissues for skeletal disease research. The collaboration has been made possible by a generous gift from the Methuselah Foundation (“Methuselah”) as part of its ongoing University 3D Bioprinter Program.
Muscoskeletal diseases are the second leading cause of disabilities worldwide, while inherited skeletal disorders affect 2.4 out of every 10,000 births. A better understanding of bone formations and constructs is critical to in vitro modeling of bone disease to promote development of drugs for bone growth and repair.
“Partnerships with world-class institutions can accelerate groundbreaking work in finding cures for critical unmet disease needs and the development of implantable therapeutic tissues," said Keith Murphy, Chairman and CEO, Organovo. “This collaboration with UCSF, which combines their expertise with our own, is another important step in this direction. With the devoted support of the Methuselah foundation, leading researchers are able to leverage Organovo’s powerful technology platform to achieve significant breakthroughs.”
“When we study skeletal diseases, such as bone cancer or heterotopic ossification, most of the research occurs in a two-dimensional environment, such as a petri dish. That tells us a lot about how cells interact with other cells, but not how they function in a natural three-dimensional scaffold,” said Dr. Edward Hsiao, assistant professor, UCSF School of Medicine. “This type of 3D bioprinting creates better mechanisms for combining inorganic scaffolds with live cells and will likely have key implications for how we repair damaged skeletal tissues, as well as many other tissues in the body.”
The partnership also includes the UCSF labs of Tamara Alliston, Chelsea Bahney, Jeff Lotz and Robert Nissenson.
Under Methuselah's University 3D Bioprinter Program, Methuselah is donating at least $500,000 in direct funding to be divided among several institutions for Organovo bioprinter research projects. This funding will cover budgeted bioprinter costs and key aspects of project execution.
"We at the Methuselah Foundation have been a long-time supporter of academic and industry research in 3D bioprinting, regenerative medicine, and tissue engineering," said David Gobel, CEO, Methuselah Foundation. "Our University 3D Bioprinter Program puts Organovo’s breakthrough 3D bioprinting technology in the hands of the brightest scientists at tissue engineering centers of excellence."
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human disease models through internal development and in collaboration with pharmaceutical and academic partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. The Company recently launched its initial product of the planned exVive3D portfolio offering, the exVive3D Human Liver Tissue for use in toxicology and other preclinical drug testing. Additional products are in development, with the anticipated release of the exVive3D Human Kidney Tissue scheduled for the third quarter of calendar year 2016. The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications. In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous other media outlets. Organovo is changing the shape of life science research and transforming medical care. Learn more at www.organovo.com.
About University of California, San Francisco
UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises two top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospital San Francisco, and other partner and affiliated hospitals and healthcare providers throughout the Bay Area. Learn more at www.ucsf.edu/news.
About Methuselah Foundation
The Methuselah Foundation is a non-profit medical charity working to create a world where 90 year olds can have the health profile of 50 year olds, by 2030. By opportunistically leveraging resources, enabling partnerships, and awarding prizes and grants, we accelerate disruptive developments in biomedical engineering that will eradicate needless suffering and extend healthy human life. For more information please visit: www.methuselahfoundation.org and www.neworgan.org.
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. 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 market acceptance of the Company's products and services; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; the Company's ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings and secure additional contracted collaborative relationships. 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 9, 2016. 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. has added a news release to its Investor Relations website.
Title: Organovo Collaborates With UCSF Team to Develop 3D Bioprinted Tissues for Skeletal Disease Research
Date(s): 13-Jun-2016 8:06 AM
I hope the Longs over here go over & read the Yahoo ONVO message board. They are giddy with expectations of a short squeeze. I'm hopeful, but realistically hoping for a a 3-6% increase.
I noticed that too. I think it's great that SGLB is using social media to get the word out about what they bring to the Additive Manufacturing industry. They seem to be putting something out almost every day - showcasing interesting builds, news, etc.
I found that article on their Facebook page.
Not sure if this was posted yet: http://immijournal.springeropen.com/articles/10.1186/s40192-016-0052-5
Started to panic, but did not sell.
Appreciate that someone from the board is going. Thanks!
Hologic (NASDAQ:HOLX) is replacing Pepco Holdings (was just acquired by Exelon) - up in after hours!
Schwab is just as bad. All I can see is the number of shares I own & the market value as of COB on Wednesday. GRRRRR
My only concern at the moment is that we gap up at the open. I prefer steady moves up.
Here's the full press release:
Home»News»Press Releases»Press Releases Details
Organovo Subsidiary Samsara Sciences Launches Commercial Operations
01/13/2016
SAN DIEGO, Jan. 13, 2016 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NYSE MKT:ONVO) (“Organovo” or the “Company”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today announced that its wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), has launched commercial operations. Samsara’s core mission is the provision of high-quality primary human liver cells for a wide variety of in vivo and in vitro research applications.
Samsara is expected to serve as a key source of primary human liver cells for Organovo’s needs in the preclinical safety and therapeutic tissues markets, allowing the Company to optimize its supply chain and operating expenses related to cell sourcing and procurement. Organovo sought to establish Samsara as a cell provider in part to support the needs of high-quality cell supply for use in the research and development of bioprinted liver tissue as a potential therapeutic product. Samsara will also provide such cells to life science customers through typical commercial channels.
Samsara will offer a comprehensive selection of human hepatic stellate cells – a key cell type in the liver that plays a major role in the development of prevalent diseases such as fatty liver disease and fibrosis. In addition to receiving detailed culture and cryopreservation protocols with each lot of cells, Samsara’s customers will have access to a full portfolio of companion services including the provision of tissue sections, nucleic acids and gene expression data. Human hepatocytes will also be made available through established distribution channels. To achieve its goals, Samsara works closely with key collaborator and liver cell biology expert, Dr. Tatiana Kisseleva and her laboratory at the University of California, San Diego School of Medicine.
“The Samsara team shares a passion for cells and is dedicated to providing the high-quality, well-characterized cellular reagents that are required to support the future of biological research and tissue products," said Dr. Sharon Presnell, President, Samsara Sciences and Chief Technology Officer and Executive Vice President of Research & Development, Organovo. “Our ultimate vision is to supply a comprehensive portfolio of tissue-specific cells that are tailored for use in the production of the multi-cellular 3D tissues that are poised to change the landscape of drug discovery and regenerative medicine.”
“Cell supply and quality are critical to meeting Organovo’s goal to change the shape of medical research and practice, including our desire to create a bioprinted liver patch for transplant,” said Keith Murphy, CEO, Organovo. “I’m grateful to the team at Samsara and its key collaborators and scientific advisors for enabling us to develop this high-quality cell source, and to offer it to other researchers through Samsara’s commercial efforts.”
About Organovo Holdings Inc.
Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human disease models through internal development and in collaboration with pharmaceutical and academic partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. The Company recently launched its initial product of the planned exVive3DTM portfolio offering, the exVive3D Human Liver Tissue for use in toxicology and other preclinical drug testing. Additional products are in development, with the anticipated release of the exVive3D Human Kidney Tissue scheduled for the third quarter of calendar year 2016. The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications. In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous other media outlets. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.
About Samsara Sciences, Inc.
Samsara is dedicated to the provision of high-quality primary human liver cells for use in pharmaceutical and academic research focused on liver health and disease. The Company’s first products, primary human hepatic stellate cells are available now at www.samsarasciences.com. Primary human hepatocytes will be distributed by a third party distributor. Samsara is a wholly-owned subsidiary of Organovo Holdings, Inc.
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. 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 market acceptance of the Company's products and services; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; the Company's ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings; and Samsara’s ability to commercialize its products and Organovo’s ability to achieve the anticipated supply chain benefits. 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 9, 2015 and its Quarterly Report on Form 10-Q filed with the SEC on November 9, 2015. 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 Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 480-2411
jessica@litldog.com
Primary Logo
Source: Organovo Holdings, Inc.
There's a new press release from Organovo. Here's the link: http://ir.organovo.com/news/press-releases/press-releases-details/2016/Organovo-Subsidiary-Samsara-Sciences-Launches-Commercial-Operations/default.aspx.
Check out this update from Motley Fool that reiterates what we already know. But gives it a negative spin with the talk of ONVO selling more shares. Just sharing - I'm still an exasperated LONG.
--
Original Post: http://www.fool.com/investing/general/2016/01/08/this-trio-of-trouble-crushed-organovo-holdings-inc.aspx
And another Linked In post:
Sigma Labs has completed its first two PrintRite3D® installs in Europe. One on MetalFab1 at Additive Industries and the other on EOS M280 at Spartacus3D.
https://www.linkedin.com/hp/update/6084795537687658496
I'm in for the long run too, just a bit frustrated with the pace of progress. Buying more as I am able.
Organovo Announces Fiscal Second-Quarter Results; Company Affirms Full-Year Fiscal 2016 and Long-Range Outlook
11/09/2015
SAN DIEGO, Nov. 09, 2015 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NYSE MKT:ONVO) (“Organovo”), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, today reported financial results for the fiscal second quarter of 2016 and affirmed its full-year fiscal 2016 and long-range outlook. Net loss was $11.3 million, or $0.12 per share, for the fiscal second quarter of 2016, as compared to $8.9 million, or $0.11 per share, for the fiscal second quarter of 2015.
Organovo reported fiscal second-quarter total revenue of $0.3 million, which consisted of $0.2 million of products and services revenue and $0.1 million of collaborations and grants revenue. Total revenue increased 502 percent versus the comparable period of fiscal 2015. Products and services revenue, which primarily represents revenue from the exVive3DTM Human Liver Tissue research service and product, increased by $0.2 million from the year-ago period. The Company commercially released the exVive3D Human Liver Tissue in November 2014.
The Company also achieved its next milestone for its kidney program ahead of schedule. Functional validation of its kidney tissue, due to be achieved in December 2015, was completed in October 2015. The Company is preparing the data, which includes functional measurement of tissue performance, as well as characteristic toxic behavior of known molecules, for submission to a peer-reviewed journal. Organovo remains on schedule to initiate contracting for this product in the calendar third quarter of 2016.
“We affirmed our fiscal 2016 and long-range outlook across the board today and are pleased with our momentum through the fiscal second quarter,” said Keith Murphy, CEO, Organovo. “We participate in attractive and growing markets with critical unmet needs, benefit from favorable competitive dynamics that come with a first mover advantage, and own a leading technology with a strong IP portfolio. Taking all this together, we expect solid revenue growth through an expanding product and service platform.”
Murphy continued, “We’ve made progress in key strategic areas, by both aligning our sales, marketing and R&D functions to optimize our commercial execution and continuing to build the scientific data that supports the predictive power of our solutions in addressing the major gaps in pharmaceutical discovery. Our commercial in vitro tissue business has an expanded footprint, with dedicated business development resources in the U.S. and Europe driving these complex solutions sales. We’re also investing significantly in developing additional data sets to grow the preclinical safety market and increase customer penetration.”
Murphy concluded, “As we look to the second half of fiscal 2016, we’re focused on a few key targets including accelerated liver tissue revenue growth, ongoing development of our kidney tissue now that we’ve achieved functional validation, and business development initiatives in the drug discovery and therapeutic tissue spaces.”
Organovo Business Highlights
Revenue
Products and services revenue was $0.2 million, up from $0.0 million in the prior-year period, primarily driven by customer contracts for the Company’s exVive3D Human Liver Tissue research services.
Collaborations and grants revenue totaled $0.1 million, largely supported by existing partnerships and research funded by grants.
Operating Expenses
Selling, general and administrative expenses grew 19 percent year-over-year to $6.8 million, reflecting increased employee costs related to sales and administrative staffing.
Research and development expenses increased 47 percent from the prior-year period to $4.7 million, primarily due to increased employee related costs and lab supplies.
Liquidity & Capital Resources
The Company ended the fiscal second quarter with a cash and cash equivalents balance of $76.9 million. Organovo’s net cash utilization(1) during the period was $9.1 million. The Company’s net cash utilization for the six months ended September 30, 2015 was $16.5 million.
Working capital was $72.3 million to end the fiscal second quarter compared to $52.0 million in the prior-year quarter.
Fiscal-Year 2016 Outlook
The Company affirmed its full-year fiscal 2016 outlook for revenue recognized from previously disclosed contract bookings for its commercial liver tissue product and net cash utilization. The Company continues to expect:
In fiscal 2016, to recognize between $1.2 million and $1.4 million of its previously reported approximately $2 million in contract bookings for its exVive3D Human Liver Tissue for the period from April 1, 2014 to June 9, 2015. The Company had already recognized approximately $0.3 million from these contract bookings in fiscal 2015. Organovo anticipates that additional revenue from these contract bookings will be recognized in fiscal 2017. In addition, revenue from new contracts signed after June 9, 2015, as well as revenue from grants and collaborations, may also be recognized during the remainder of fiscal 2016.
Net cash utilization of between $32 million and $36 million for fiscal-year 2016. The Company had a cash and cash equivalents balance of $76.9 million for its fiscal second quarter ended September 30, 2015.
Fiscal-Year 2016 Outlook
(September 2015)
Fiscal-Year 2016 Outlook
(November 2015)
Total Revenue Recognized
From Previously Reported
Contract Bookings $1.2 million - $1.4 million Affirmed
Net Cash Utilization
$32 million - $36 million Affirmed
Long-Range Outlook
The Company affirmed its long-range outlook for potential revenue from its liver tissue product and initiation of commercial contracting for its kidney tissue product. The Company continues to expect:
As it penetrates the toxicology market, Organovo’s exVive3D Human Liver Tissue and service will grow into the tens of millions in annual revenue, and has $100 million+ revenue potential in the future (inside of a total addressable market of over $1 billion).
Initiation of commercial contracting for its kidney tissue product in the calendar third quarter of 2016.
Net Cash Utilization Definition
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 change in the amount of cash and cash equivalents at the beginning of the reporting period as compared to the end of the reporting period, excluding financing activities (which would include proceeds from the sale of common stock and the exercise of warrants and stock options). Net cash utilization is an operational measure that should be considered in addition to our results prepared in accordance with U.S. GAAP. This operational measure should not be considered as a substitute for, or superior to, 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 5:00 p.m. ET on Monday, November 9, 2015. 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 9182401. 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 Monday, November 9, 2015 through Monday, November 16, 2015 at Organovo’s Investor Relations webpage. Callers can also dial (877) 344-7529 (U.S. only) or (412) 317-0088, Access Code 9182401, for an audio replay of the conference call.
About Organovo Holdings Inc.
Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human disease models through internal development and in collaboration with pharmaceutical and academic partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. The Company recently launched its initial product of the planned exVive3D portfolio offering, the exVive3D Human Liver Tissue for use in toxicology and other preclinical drug testing. Additional products are in development, with the anticipated release of the exVive3D Human Kidney Tissue scheduled for the third quarter of calendar year 2016. The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications. In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous other media outlets. Organovo is changing the shape of medical research and practice. 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. 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 market acceptance of the Company's products and services; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; and the Company's ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings. 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 9, 2015 and its Quarterly Report on Form 10-Q filed with the SEC on November 9, 2015. 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)
September 30, 2015 March 31, 2015
Unaudited Audited
Assets
Current Assets
Cash and cash equivalents 76,863 50,142
Accounts receivable 180 -
Inventory 68 66
Prepaid expenses and other current assets 714 1,054
Total current assets 77,825 51,262
Fixed assets, net 3,633 2,042
Restricted cash 79 79
Other assets, net 139 106
Total assets $ 81,676 $ 53,489
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable $ 567 $ 1,387
Accrued expenses 2,421 2,257
Deferred rent 1,112 759
Deferred revenue 1,402 227
Current portion of capital lease - 5
Warrant liabilities 16 126
Total current liabilities 5,518 4,761
Deferred revenue, net of current portion 7 32
Total liabilities $ 5,525 $ 4,793
Commitments and Contingencies
Stockholders’ Equity
Common stock 92 82
Additional paid-in capital 218,102 170,909
Accumulated deficit (142,043 ) (122,295 )
Total stockholders’ equity 76,151 48,696
Total Liabilities and Stockholders’ Equity $ 81,676 $ 53,489
Organovo Holdings, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands)
Three Months Ended Three Months Ended Six Months Ended Six Months Ended
September 30, 2015 September 30, 2014 September 30, 2015 September 30, 2014
Revenues
Product and service $ 187 $ - $ 396 $ -
Collaborations 19 45 33 114
Grants 95 5 178 35
Total Revenues 301 50 607 149
Selling, general, and administrative expenses 6,846 5,777 11,468 9,472
Research and development expenses 4,739 3,229 8,881 6,043
Operating Expenses 11,585 9,006 20,349 15,515
Loss from Operations (11,284 ) (8,956 ) (19,742 ) (15,366 )
Other Income (Expense)
Change in fair value of warrant liabilities 9 94 (28 ) 64
Loss on disposals of fixed assets - (3 ) - (3 )
Interest income 18 7 25 14
Total Other Income (Expense) 27 98 (3 ) 75
Income Tax Expense - - (3 ) -
Net Loss $ (11,257 ) $ (8,858 ) $ (19,748 ) $ (15,291 )
Organovo Holdings, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
Six Months Ended Six Months Ended
September 30, 2015 September 30, 2014
Cash Flows From Operating Activities
Net loss $ (19,748 ) $ (15,291 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Loss on disposal of fixed assets - 3
Depreciation and amortization 324 208
Change in fair value of warrant liabilities 28 (64 )
Stock-based compensation 3,952 3,634
Amortization of warrants issued for services (105 ) 469
Increase (decrease) in cash resulting from changes in:
Accounts receivable (180 ) (30 )
Inventory (2 ) (7 )
Prepaid expenses and other assets 337 113
Accounts payable (820 ) 204
Accrued expenses 164 737
Deferred rent (21 ) 223
Deferred revenue 1,150 124
Net cash used in operating activities (14,921 ) (9,677 )
Cash Flows From Investing Activities
Purchases of fixed assets (1,550 ) (576 )
Proceeds from disposals of fixed assets 14 -
Purchases of intangible assets (35 ) -
Net cash used in investing activities (1,571 ) (576 )
Cash Flows From Financing Activities
Proceeds from issuance of common stock and exercise of warrants, net 43,137 16,291
Proceeds from exercise of stock options 81 188
Principal payments on capital lease obligations (5 ) (4 )
Net cash provided by financing activities 43,213 16,475
Net Increase (Decrease) in Cash and Cash Equivalents 26,721 6,222
Cash and Cash Equivalents at Beginning of Period 50,142 48,167
Cash and Cash Equivalents at End of Period $ 76,863 $ 54,389
Investor Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 480-2411
jessica@litldog.com
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Source: Organovo Holdings, Inc.
Organovo Holdings (NYSEMKT:ONVO): FQ2 EPS of -$0.12 misses by $0.02.
• Revenue of $0.3M in-line.
UniQuest Licenses Intellectual Property to Organovo for Kidney Toxicity Screening and Drug Development
10/13/2015
BRISBANE, Australia and SAN DIEGO, Oct. 13, 2015 (GLOBE NEWSWIRE) -- UniQuest, the main technology transfer and commercialisation company of The University of Queensland (UQ), has signed an exclusive worldwide licensing agreement with Organovo Holdings, Inc. (NYSE MKT:ONVO), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, to patent applications relating to methodology for producing kidney cells from induced pluripotent stem cells (iPSCs).
Professor Melissa Little and her team at UQ’s Institute for Molecular Bioscience developed a method of growing kidney tissue from iPSCs for potential use in drug screening, disease modelling and cell therapy.
The research, published last week in the prestigious scientific journal Nature, has shown that this method forms an organ with all the cell types normally present in the human kidney. Previously, Professor Little and her team grew a “mini-kidney” in a dish that contained two cell types, but the team have now gone one step further to develop the method of growing more complete kidney tissue, using iPSCs.
“The mini-kidney we have been able to grow is very complex and more like the real organ,” Professor Little said. “This is important for drug testing as we hope these mini-kidneys will respond to the drugs as a normal organ might.”
Organovo will further develop the intellectual property with the support of Professor Little and her team for commercial applications such as kidney disease modelling, nephrotoxicity screening and discovery of compounds which may improve renal function for patients with genetic kidney disease. Separately, Organovo is developing a kidney proximal tubule tissue product using its bioprinting technology scheduled for release in 2016; products that would incorporate the newly developed technology licensed from UniQuest to provide a complete kidney tissue would be expected to be launched later.
Organovo’s Chief Technology Officer, Sharon Presnell, Ph.D. commented, "We are excited to license this groundbreaking technology to enable the development of human kidney tissues that could change the landscape of drug testing and kidney research. Working with leading scientists such as Professor Little extends our leadership position in the generation and commercialization of tissues that better recreate in vivo human biology.”
UniQuest CEO Dr. Dean Moss said, “This deal is anchored in world-leading induced pluripotent stem cell research by Professor Melissa Little and follows a research collaboration between The University of Queensland and Organovo, facilitated by UniQuest. We are delighted to work with Organovo so that they can further develop and commercialise the technology to accelerate the drug discovery process and enable treatments to be developed faster and at lower cost.”
Under the terms of the agreement, Organovo is granted worldwide development and commercialization rights for in vitro applications. In addition to an upfront technology access fee, UniQuest is eligible to receive milestone and royalty payments. No specific terms of the deal were disclosed.
About Organovo Holdings Inc.Organovo designs and creates functional, three-dimensional human tissues for use in medical research and therapeutic applications. The Company develops 3D human disease models through internal development and in collaboration with pharmaceutical and academic partners. Organovo's 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. The Company recently launched its initial product of the planned exVive3D portfolio offering, the exVive3D Human Liver Tissue for use in toxicology and other preclinical drug testing. Additional products are in development. The Company also actively conducts early research on specific tissues for therapeutic use in direct surgical applications. In addition to numerous scientific publications, the Company's technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous other media outlets. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.
Forward-Looking StatementsAny 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. The factors that could cause the Company's actual future results to differ materially from current expectations include, but are not limited to, the risks and uncertainties 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 9, 2015 and its Quarterly Report on Form 10-Q filed with the SEC on August 10, 2015. 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 Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com
Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 480-2411
jessica@litldog.com
There's some related news: http://mobile.abc.net.au/news/2015-10-08/proto-kidney-grown-in-a-dish/6833882
Never buy (or sell) at market.
This was a good option's expiration Friday! Hope Monday follows suit. Go ONVO!
Nice ~124k share purchase right after the close today!
Nice ~124k share purchase right after the close today!