Like buying Apple in 1997,buy Organovo today .....
HeinerMueller : @basia45: ...
basia45 : Hallo Heiner
wenn man die Zusammenhänge und die näheren Umstände nicht kennt,dann sollte man sich auch kein Urteil bilden .
Du glaubst wohl immer noch an den Weihnachtsmann und dass die Banken nur langweilig gemanagte Fonds unter die Leute bringen.bei denen man nicht allzuviel verlieren kann.
Aber wenn ich einen Totalverlust von 1000€ mit dem ich rechnen muss, erleide,tut es bestimmt nicht so weh, als wenn ich eine Summe von ca 150 000 € mit einem hochheiligen Sicherheitsversprechen verliere.
Die Rechtsprechung kann einem da auch nicht viel weiterhelfen,da ja der Anleger in der Beweispflicht ist.Und wie will man das schon beweisen???
Kein Berater wird vor Gericht aussagen,dass er nicht auf die entscheidenden Punkte hingewiesen hat.Ich habe auch keine Fragen gestellt,da ich mir einfach nicht vorstellen konnte,dass das für angelegte Geld von einem Tag zum anderen verloren sein könnte.
Das die Banken solche Produkte mit dem Zusatz der absoluten Sicherheit und unter Vorspiegelung falscher Tatsachen (falsche Grafiken usw) vertreiben war mir neu.
Also was sollte mir denn nun noch schlimmeres passieren ????
proinpro : Viel Spaß mit dem Bericht
Let's face it, we're getting older. Not just each of us individually, of course, but society as a whole. According to the Census Bureau, the median age in the US today is over 37 years, compared to about 29 years back in 1960. Thanks to advancements in medicine and a higher overall standard of living, the average person born in the US today can expect to live to about 79, according to the CDC, compared to 70 in 1960 and just 60 in 1930. The percentage of the US population aged 62 years and over is now 16.2%; it was less than 12% in 1980. Today, there are 40 million people in the US aged 65 and older, and this number is projected to more than double to 89 million by 2050. This is not just the case in the US. It's a firmly established trend taking place throughout the world. In 1970, the world's median age was 22.1. That figure has climbed nearly 30% in the past four decades to 28.4.
For those of us who enjoy life, this is, of course, good news. But it's not all roses, unfortunately. Modern medicine is doing a better job of keeping us alive. But as we age our organs tend to fail more.
Organ transplants have been around for more than half a century, and some have become quite routine. But the central problem with them has been the same for fifty years: the number of worthy recipients at any given time always far outstrips the number of willing donors. That is not likely to ever change. With our aging population, in fact, it's going to get worse. Over the last decade alone, the number of patients waiting for a transplant has more than doubled, while the actual number of transplants has remained relatively flat.
If donors and recipients were the only two parts of the equation, then nothing could be done. But technology doesn't sit on an imperfect solution. It moves on, in this case to regenerative medicine. [Ed. note: Summarizing the state of regenerative medicine is beyond the scope of this article, but a good source on the subject is this clip from Dr. Anthony Atala of Wake Forest University, presented at a TEDMED conference a few years ago.]
But regenerating organs is a difficult and complex process and requires a great deal of time for tissue to naturally grow. Is there an even better way? Well, maybe you can print them.
We've covered 3D printing in the past (September 12, 2011 and February 2, 2012), but fully functioning organs are a huge leap beyond plastic prototypes and even fully-dense metal final products. Dr. Atala is also very much involved in this cutting-edge science as well; but it's still very early stage – no one has received a printed kidney transplant yet.
Dr. Atala and his team are not the only players in the game, however. Organovo – a company at the cutting edge of this revolutionary technology known as "bioprinting" – has gone public in the past year, allowing ordinary investors to participate in arguably the most exciting and potentially profitable of all 3D printing technologies: to print human tissues and organs.
Organovo was founded in 2007, began operations in 2009, and became publicly traded over the counter under the symbol "ONVO" in February 2012. The company develops three-dimensional human-tissue printing technology to create tissue on demand for research and surgical applications. Its technology platform works across various tissue and cell types to serve physicians and researchers in the fields of cardiovascular medicine, medical research, and transplant medicine.
This technology, which has the potential to create fully functional tissues (and ultimately organs) cell by cell, is based on the fact that a cluster of human cells (what the team at Organovo calls "bio-ink") behaves just like a liquid. When placed next to one another, the bio-ink particles (each composed of between 10,000 and 30,000 cells) will flow together and fuse, forming layers or other shapes. To build 3D structures like organs, Organovo uses a printer to assemble the human cells into the desired shape. It's similar to how an inkjet printer produces words.
The company's NovoGen MMX Bioprinter works by first creating a sheet of cell-friendly bio-paper. Then it prints out the living cell clusters onto the paper drop by drop. Once in place, the bio-paper dissolves and nature takes over, as the cell clusters fuse to each other, creating more complex tissue structures. The scientists at Organovo cannot control every detail of the process, but it turns out they don't have to: the biological material by its fundamental nature is able to self-organize. As each layer is completed, another layer of cell clusters is added.
To date, the company has only printed small pieces of human tissue. But since cells from any organ can be put through this printing process, Organovo foresees using this technique to print complete organs for transplant. These organs would be printed from a patient's own cells, which would minimize the chance of rejection.
Exciting stuff. It's no wonder Organovo landed itself on the MIT Technology Review's 2012 list of the world's most innovative tech companies. Eventually, we may even get to the point where the printer can print the new organ right into the recipient's body. While 3D printing working human organs is most likely still at least a decade or more away, that has not prevented a couple of meteoric rises (and falls) in ONVO stock.
Just take look at ONVO's one-year price chart. (The chart shows daily closing prices.)
(Click on image to enlarge)
ONVO went public at $1.65 per share on February 14, 2012 and experienced some impressive momentum out of the gate, climbing to $3.01 (an 82% increase) by May 17. That's when things really went crazy. Just one month later, ONVO traded as high as $10.90 (a 560% increase from the close on its first trading day just four months prior) after some of the larger newsletter companies like Motley Fool wrote numerous positive articles about the company and helped propel it to a $500-million market cap (despite no change in fundamentals) virtually overnight.
Think about that for a second. ONVO was trading for half a billion dollars despite generating less than $1 million in revenue during the prior twelve-month period. Yes, that's a price-to-sales ratio of over 500. And it's not like the forward one- or even two-year revenue projections were calling for growth that could come close to justifying that valuation. The numbers just didn't make sense. When investors once again came to their senses and recognized this reality, the stock fell – hard. By mid-July 2012, ONVO was once again trading below $2.00 per share. Despite a brief pop above $3 per share in mid-October, the stock remained flat through mid-December.
But the stock has been on another big move over the past month. On December 18, the company announced that it had joined forces with researchers at Autodesk (ADSK), a leader in 3D design, engineering, and entertainment software, to create the first 3D design software for bioprinting. The company hopes that the software, which will be used to control Organovo's NovoGen MMX bioprinter, leads to advances in bioprinting – including both greater flexibility and throughput internally and the potential long-term ability for customers to design their own 3D tissues for production by Organovo.
The day before the company announced this news (December 17), ONVO closed at $2.10. On January 22, 2013, the stock closed at $5.91, reflecting a 181% increase (and a market capitalization of $346 million based on the current share count reported by S&P Capital IQ). At least the recent run-up coincided with one positive fundamental development for the company; i.e., the collaboration with Autodesk. But let's look at what that really is – an agreement with no terms, no numbers, nothing that's been done – just a press release from Organovo saying basically that "we're going to get together with these guys and do something." Not really earth-shattering news. Autodesk did not consider it important enough even to issue a press release.
What's really going on here, just like before, is hype. There have been some positive articles about Organovo circulating among the major financial news sites over the past couple weeks. That has sparked renewed interest in the stock and taken it to an outlandish valuation despite the underlying fundamentals of the situation. And in the past two days, in fact, we've seen reality start to set in again as shares of ONVO are down 34% from Monday's close to $3.89 as of this writing.
To be fair to the company and those caught up in the hype of the stock, however, I need to point out that I'm a long-term Organovo bull, but would only buy today at a much lower valuation. However, the possibility for significant, relatively near-term revenue is quite real. In other words, we won't have to wait until Organovo is printing fully functional human organs before the stock makes sense as a legitimate investment opportunity.
The immediate opportunity for the company is in tissue printing for drug makers. As you no doubt know, in order for biotech and pharma companies to market their drugs in the US, they first must receive FDA approval. I won't go into a lengthy description of that approval process here, but I will note that bringing a drug from the pre-clinical or discovery phase all the way to market can easily take more than a decade and cost significantly more than $1 billion. (Only about 1 in 10,000 compounds evaluated in the pre-clinical stage will ever successfully navigate the entire process.)
A big part of that pre-clinical phase involves assessing safety and biological activity in the laboratory – especially in animal studies. (It's difficult to access reliable figures, but it's safe to say that billions of dollars a year is spent on animal tests.) The problem with these animal models (without even touching on the various potential ethical issues involved) is that although they have historically been one of the most trusted tools in drug development, they are not actually all that predictive of the human situation. Not only do animal models fail to identify numerous drugs that are toxic to humans, they also derail drugs that would have been good treatments for patients.
Organovo's technology has the potential to help solve this problem. The company can fill the gap between animal models that are used today but often don't provide the best answer and clinical trials in humans – by creating this functional, living human tissue with a three-dimensional architecture that allows for doing drug testing there. As Organovo scientists have said, "If this tissue resembles an equivalent to a human liver, architecturally, structurally, and even functionally, then we could use it to test the drug… after successful or promising animal trials. Then move on to real human trials if those tissue tests prove successful."
This is something that pharma companies have never had access to before, and it has the potential to lead to safer and more effective drugs and to do so faster and cheaper (if it can reduce failure rates in clinical trials). We've already seen some progress here, as the company has entered into two separate research contract agreements with third parties (believed to be Pfizer and United Therapeutics), but there's still a long way to go.
So, to answer the question posed by this article: Organovo is both a good company and a lesson in hype. I'm extremely bullish on the company's long-term prospects, but there are some big risks in the meantime – including large mounting losses, very uncertain future revenues, and a relatively weak cash position that will necessitate shareholder dilution or taking on debt over the next year – that should keep the market valuation below a couple hundred million dollars over the short run.
Chalifmann3 : hi chilli
Chalifmann3 : hi proinpro
Es läuft gut,man muss garnicht viel streuen,eine breite Streuung bewirkt doch nur,dass man insgesamt immer plusminus 0 dasteht,das bringt doch nix !!
Chalifmann3 : es muss nicht immer alternativ sein
proinpro : @Chalifmann3
Bei deiner Aussage zur Solarenergie kann ich dir nicht zustimmen! Den Wert einiger deutscher, europaeischer oder generell westlicher Solarunternehmen zu nehmen und deren Entwicklung mit der Sonnenenergie im Allgemeinen zu vergleichen, das ist keine kompetente Aussage, nichts fuer Ungut! Dass viele westliche Solarunternehmen so darstehen wie heute, das liegt ja nicht an der Energiequelle an sich, wenn auch man mehr Sinn in ihrer Anwendung in sonnenreicheren Regionen sehen mag. Die Technologie schreitet auch hier voran, die Sonnenenergieausbeute steigt stetig, wenn auch in kleinen schritten..im uebrigen massgeblich (noch) durch die F&E Arbeiten einiger deutscher Unternehmen. Der Solarstrom wird immer konkurrenzfaehiger. Entscheidend ist aber, dass du einfach missachtest, dass die westlichen Solarunternehmen so schlecht darstehen, weil die mit dem Preisdruck aus Fernost kaum bis nicht mithalten koennen. Teils selbst verschuldet, weil man sich lange Zeit zufrieden mit der guten Entwicklung gab und die Reinvestitionen in F&E vergleichsweise ungenuegend waren und man so seinen Technologievorsprung schneller los war, als es den Unternehmen lieb sein konnte. Auch einige visionaere Firmenmitgruender von z.B. Solon oder QCells haben sich nicht blenden lassen und haben sehr wohl sehr frueh erkannt, dass man den Wettbewerb mit den Chinesen ueber lang nicht bestehen koennen wird und haben sich teilweise in neue unternehmerische Projekte gestuerzt, um die Entwicklung von EE, auch Solarenergie!, weiterhin zu unterstuetzen, bspw. in Forn von innovativen Speichertechnologien. Erste Projekte auf Inseln mit bis zu 100% EE und somit der Abkehr von Oel sind in der Umsetzung. Dort rechner sich das Zusammenspiel von Solaranlagen, Windkraft, Batteriespeichern und einem intelligenten Netz schon heute gegenueber dem Import des Oels.
proinpro : Beitrag
Ah, Grasshopper, so you are troubled by the changing value of your share in Organova Holdings, Inc. (ONVO.PK)? You say in June it was worth $10.90 and three weeks later it was worth $1.93. You say that throughout most of December, it was worth little more than $2.00, but Monday of this week it rose to $6.00 before falling Tuesday to as low as $4.00, and now you wonder about tomorrow? Sit down Grasshopper, stop pulling your hair, and listen to how a LTBH Zen Master waits for a butterfly to stop its fluttering and alight.
Transformative Technologies and the LTBH Investor
We are long-term, buy and hold ("LTBH") investors, you and I, and so we hold a mixture of value and growth equities. A subcategory of our growth equities is companies possessed with the potential of a transformative technology.
By transformative technology, we mean a unique, proprietary product with the potential to fundamentally change a significant aspect of the market.
Some of companies with transformative potential are large and established, like International Business Machines Corporation (IBM) with its big data and carbon nanotube technologies or ABB, Ltd. (ABB) with its direct current circuit breaker. These companies lumber across the earth with nary a sideways glance; there are no predators large enough to harm them, only choosing a wrong path leading to a barren landscape threatens their existence.
Others are smaller and fear predators; they scurry through the underbrush, eating smaller creatures but growing in confidence, companies like Nuance Communications, Inc. (NUAN) with voice-recognition technologies or Clean Energy Fuels Corp. (CLNE) providing natural gas fueling to truckers.
And still others are the smallest of all, tiny little companies just emerging from their nests or pupa, companies like Arcam AB (AMAVF.OB) selling a few dozen high end 3D printers annually to aerospace and medical companies, or Organova Holdings, Inc., developing the 3D printing of human tissue.
It is these babes that cause us such worries, Grasshopper. Like little ONVO, recently emerged and starting to flutter its wings. If we watch it too closely, we become dizzy with its ups and downs. The Zen of LTBH investing, Grasshopper, is to visualize the path and not watch the fluttering.
The LTBH Philosophy
Remember, Grasshopper, why we are LTBH investors and not day traders, mutual fund, or ETF investors:
Equity markets offer superior returns to many other investing options, so we ask not whether to invest in equities, we ask how to invest in equities
We know the path of frequent trading costs more in broker fees, capital gains taxes, time and energy
We know what we cannot know; professional traders have the edge in timeliness of information, speed of execution, and transaction costs
We know that, with discipline, we can win against mutual funds (because of their burden of fees and expenses and, in some cases, our ability to invest in smaller companies) and we can win against ETFs (because of their expenses and our ability to be more selective).
The LTBH Rationale for Investing in Organova
Remember, Grasshopper, the reasons why we invested in Organova. Its transformative technology is the 3D printing of human tissues for drug discovery and development, biological resources, and therapeutic implantation. It is conceivable that one day Organova machines could print entire human organs like a liver, a kidney or a heart to be therapeutically implanted into a person and save their life. This potential is the very embodiment of a transformative technology.
Yet we also know that Organova is still a delicate creature. It is a long way from having a proven product and it is incurring substantial operating losses. In the third quarter of 2012, according to its 10Q filing and an excellent Seeking Alpha article by PropThink, it had essentially three sources to its $469,238 operating revenue:
$298,800 in collaboration fees from United Therapeutics (UTHR)
$75,000 in collaboration fees from Pfizer (PFE). This collaboration expired in December 31, 2012 and is expected to be replaced with a new agreement, but no such agreement has yet been announced.
$95,500 from a National Institutes of Health grant
We know its expenses are running at 182% of revenues, comprised of selling, general and administrative expenses at $550,157 and research and development expenses at $304,251. But still the tiny company expresses confidence in its financial position. At September 30, 2012, they report having working capital of $7.2 million, "sufficient to fund our ongoing operations… for at least the next 12 months." In addition, Organova is in the process of resolving outstanding stock options that will remove a large liability from its balance sheet and position it to move from OTC to the NASDAQ capital markets in 2013.
What is Organova's Future Value?
We do not know what the future holds for Organova, only that it lies somewhere on a continuum between nothingness and becoming a multi-billion dollar behemoth. The possibilities are likely distributed on a bell-shaped curve with some outcome towards the middle as the most likely.
But with this knowledge, and some simple probability calculations, we can formulate an estimate of Organova's long-term value and thus find a Zen-like peace as the market flutters before us. Consider Organova's future as depending on two key issues: (1) proving great value in the 3D printing of human tissue and (2) establishing exclusivity or dominance with this technology. If both of these issues develop strongly in Organova's favor, it will become fabulously valuable. But there's a high degree of risk that one or both may not fully occur. There may be as yet undiscovered technical reasons why 3D printing is not feasible, or why it will be supplanted by another, superior method of creating human tissue. Another company may invent an alternative method for 3D printing of human tissue without violating Organova's intellectual property rights.
Using these two issues, we can project a range of potential outcomes for Organova and lay the basis for calculating an expected present value of the stock. As an example, I would propose that each of the following five scenarios are potential outcomes for Organova:
Scenario #1: Organova has minimal value (five year target share price $0 to $2). 3D printing of human tissue proves to have little value. Organova may go out of business, be acquired by someone else, or survive as a small company selling a limited number of 3D printers to research organizations.
Scenario #2: Organova has a value of $100 million to $500 million (five year target share price $2 to $10). Organova has annual earnings of $10 to $25 million a few hundred to a few thousand 3D printers annually, plus supplies and technical support, again to research organizations.
Scenario #3: Organova has a value of $500 million to $2 billion (five year target share price $10 to $40). 3D printing of human tissues becomes a standard mainstream research methodology and Organova is the premier provider of this technology. Many thousands of printers are sold annually. Organova trends towards annual earnings in the range of $50 to $100 million.
Scenario #4: Organova has a value of $2 to $5 billion (five year target share price $40 to $110). 3D printing of human tissues becomes an accepted therapeutic methodology for creating implants. There are competitors who have created alternatives around Organova's intellectual property protections. Organova shows the potential to generate eventual earnings in the hundreds of millions.
Scenario #5: Organova has a value of more than $5 billion (five year target share price more than $110). 3D printing of human tissues is an accepted therapeutic methodology and there are effectively no competitive alternatives. Organova has the potential to generate tens of billions in revenues and billions or more in earnings.
Don't Panic! Stay Calm. Ommmm…
So, Grasshopper, do you know that it's not the fluttering of the stock price that concerns us, it's the journey's end. If you agree with the assumptions I've described, we can assign probabilities to each, estimate what Organova's value might be if each scenario occurred, and then calculate an expected value. (If you don't agree with the assumptions I've described, it's a simple exercise to create your own). Look at this table I've drawn here in the sand:
Expected Organova Share Value
5Y Target NPV Prob. Value
Scenario #1 $0.00 $0.00 20% $0.00
Scenario #2 $2.00 $1.24 20% $0.25
Scenario #3 $10.00 $6.21 20% $1.24
Scenario #4 $40.00 $24.84 20% $4.97
Scenario #5 $110.00 $68.30 20% $13.66
In Scenario #2, for example, Organova shares would have an estimated value of $2.00 in five years. Discounting this by 10% per year, we calculate a Net Present Value of $1.24. We assume this scenario has a 20% chance of occurring, so the expected value of Scenario #2 is $0.24. By adding the expected value of all the outcomes we identified, we arrive at a share value today that reflects our expected returns: $20.12.
Meditate on this, Grasshopper, for this guides us to know where our "buy", "sell" and "hold" prices lie. If the price tomorrow hits $20.12, we should sell. We might even sell for a little bit less than this in order to grab a sure thing. But we aren't going to sell for, say, $12.00 what we think is worth $20.12.
To find our "buy" and "hold" points, we must reflect deeply on what our table of probabilities is telling us. One thing it tells us that there's a 60% chance that Organova isn't worth more than $6.21 today. The only reason we're not selling at $6.21 is because we're hoping that Scenario #4 or #5 will occur and Organova is a "home run" stock. Yet our assumptions say that, much as we might hope this will happen, the odds less than 50%.
So, Grasshopper, I would certainly not "buy" Organova at more than $6.21. In fact, being somewhat cautious, I would likely split the difference between the $6.21 and the $1.24 and use the resulting $3.72 as the most I would pay. My rationale is that $3.72 is the point where I have a 50% chance of getting at least a 10% return on my investment over the next five years. (Note, however, that if I get less than a 10% return, it will probably only be a little less; on the other hand, if I get more than a 10% return, I might get much, much more).
I believe, Grasshopper, that LTBH investors should have a small place for volatile small-cap stocks in their portfolios. Not just one, but several because the chances of any one being a home run is small, but the return from a home run will offset losses from the others which don't develop.
As we hold these stocks, we need to realize that there are others who trade using different philosophies. There will be great volatility in many small stocks. Don't let the fluttering of the butterfly become a fluttering in your stomach. Keep your eye on the prize, Grasshopper. We LTBH investors are not looking to sell at $4 or $6 or $10; while we continue to believe this stock can be a home run, we're holding. I find that doing this sometimes requires the patience of a Zen master.
proinpro : roter Tag für die 3D-Druckerpapiere
Chalifmann3 : seekingalpha aktuell ...
The company also has a division which aims to work directly with pharmaceutical companies who are looking for more efficient ways to test new drugs. One of the major problems that pharmaceutical companies can face when bringing new drugs to market are the drugs failing to meet FDA safety approvals after lots of money has already gone into early stage testing. Unfortunately for the drug companies it is unapparent to them that their drug candidates are going to fail until late stage testing. At this point millions of dollars have already gone into early and mid stage clinical testing. One of the major causes of failure for these drugs is that while the drugs worked well in tests using animal models, the success did not carry over to human tissues, inevitably causing the drugs to be unapproved by the FDA as a result.
"We can make any tissue and any disease model," states Dr. Eric David, Organovo's CSO. Dr. David feels this gives the company a tremendous power by giving them the ability to test drugs on both manufactured healthy tissues as well as manufactured diseased tissues which the company creates. Since most drug failures are encountered in late clinical testing phases, Organovo aims to give pharmaceutical companies the ability to test their products on living human tissue right from the start. This can give them much better and clinically predictive pre-clinical results on human tissue models. "This is something they have never had access to before," states Dr. Eric David. Pharmaceutical companies often hold numerous potential drugs of which to consider initiating testing for FDA approval on. Trying to figure out which of these drugs has the best potential for approval can often be like shooting craps. Organovo aims to enable these pharmaceutical companies to engage in pre-clinical testing using human tissues, which in turn will save them both time and money and can allow them to pick a drug that has a better chance of succeeding in the long run during clinical trials.
The final area of Organovo's business model I'd like to take a look at is the field of organ transplants. The companies ultimate goal in this area is to create organs derived from a patients own cells which can then be used for patients needing transplant surgeries. This appears to be one of the companies longer term thrusts and is a much needed area of medical necessity. If the company can pull this off then there is no telling where it could take them in the future. It would certainly hurt black market organ sales.
While Organovo's business ventures are certainly revolutionary in aim, I believe the stock should still be considered as highly speculative in nature as this is a newly emerging field with early stage developments in place. As well, since the concept of organ manufacturing seems to be in very preliminary stages I would consider this stock to be a longer term investment rather than short term. The company has not turned the corner to profitability thus far and predicting if or when the company will become profitable is not possible for me to say. What sets Organovo apart in my opinion as being one of the most distinct of the 3D plays is its niche market in the biotech space as well as its patents held. Being that the company has already inked out partnerships with Pfizer (PFE), United Therapeutics (UTHR) and Autodesk Inc. (ADSK) I feel that the exposure the company sits to grow with is quite large. Yet the final area that Organovo might wind up taking off in is as a buyout target for its partners or competitors alike. With 3D systems, Inc. alone taking over 16 companies in the field since early 2011, I cannot see how Organovo could not be on their radar list of potential acquisitions. In the event that a takeover is in Organovo's future, investors may find themselves cashing out much earlier than they'd hoped.
proinpro : Press Release
SAN DIEGO, Jan. 30, 2013 /PRNewswire/ -- Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, and the Knight Cancer Institute at Oregon Health & Science University (OHSU), a national leader in translational oncology research, have formed a collaboration to develop more clinically predictive in vitro three dimensional cancer models which will ultimately advance discovery of novel cancer therapeutics. New biological models that more accurately replicate human cancer and malignant disease are desperately needed to enhance our understanding of how cancer develops and migrates and to deliver better oncology therapies for patients.
"The OHSU Knight Cancer Institute is consistently on the leading edge of cancer research, delivering true therapeutic breakthroughs like Gleevec," said Keith Murphy, chairman and chief executive officer at Organovo. "The knowledge and experience of the team at OHSU will be critical as we work together to create advanced models of cancer and metastasis that more reliably predict the safety and effectiveness of new therapeutics."
Today, animal models and cancer cell lines are used to identify and test potential drug candidates, but these tools have known limitations in their ability to predict clinical outcomes. More accurate and representative human disease models have the potential to improve drug discovery and development for a number of diseases, including cancer. By applying breakthrough bioprinting technology, Organovo develops three-dimensional, architecturally correct, human disease models to improve the understanding of drug toxicity and efficacy earlier in the drug development process, enabling safer, more effective therapies.
"A major challenge in oncology research today is that animal models cannot accurately represent human physiology, and cell lines do not provide information on how cells act in a three-dimensional, native architecture," said renowned cancer researcher Joe W. Gray, Ph.D., director of the OHSU Center for Spatial Systems Biomedicine (OCSSB), Gordon Moore chair of Biomedical Engineering in the OHSU School of Medicine and associate director for translational research for the OHSU Knight Cancer Institute. "Using Organovo's bioprinting technologies, we plan to create new models to understand cancer disease mechanisms and metastatic progression, which can be used to discover and test new targeted therapies."
OHSU Knight Cancer Institute Director Brian Druker, M.D., added, "Better research models lead to a deeper understanding of disease mechanisms and more accurate information in the preclinical drug discovery and development process.
We believe new technologies, like bioprinting, are important for producing more relevant models of cancer and metastasis to ultimately support the discovery of new therapeutics."
About the OHSU Knight Cancer Institute
The Knight Cancer Institute at Oregon Health & Science University is a pioneer in personalized cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down cells that enable cancer to grow without harming healthy ones. This breakthrough has helped make once-fatal forms of the disease manageable and ushered in a new generation of targeted cancer therapies. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle—an honor earned only by the nation's top cancer centers. It offers the latest treatments and technologies as well as hundreds of research studies and clinical trials. For more information, visit www.ohsu.edu/knight-cancer-institute
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The company is collaborating with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. In addition to numerous scientific publications, their technology has been featured in The Wall Street Journal, Time Magazine, The Economist, and numerous others. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may 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 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 based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including our current report on Form 8-K/A filed on May 11, 2012. We do not undertake to update these forward-looking statements made by us.
SOURCE Organovo Holdings, Inc.
proinpro : Artikel v. seekingalpha zur Presseveröffentlichung
Knight Cancer Institute will be employing Organovo's NovoGen MMX bioprinter to stem biological models that accurately replicate human cancer to enhance understanding of the disease. These new models that imitate human cell structures are better representations than the current animal based models used to identify potential drug candidates. In turn, it is hoped that this will deliver better oncology therapies for patients by extracting more accurate information in the preclinical drug discovery & development process.
This partnership further validates the recent buzz circulating Organovo as this move demonstrates the company is committed to ensuing rewarding alliances which present minimal downside risk. Instead of selling bioprinters to just anyone, ONVO is strategically associating with educational institutions, like Knight Cancer Institute, or drug developers, such as the collaboration with United Therapeutics (UTHR), that will utilize the NovoGen MMX in a potential drug discovery process. In case of a breakthrough or a successful product that is commercialized, ONVO would receive sales-based royalties due to their contribution with NovoGen MMX. If applicable, this could add, yet again, additional revenue streams for ONVO on top of the payments originally negotiated. To boot, academic affiliations are a cheap method of advancing the technology as funding is provided from government bursaries or research firms (instead of Organovo). As more renowned researchers and academia realize the potential of the bioprinting technology, exposure will continue to spread, opening countless more doors for Organovo.
Organovo's strategy to include royalty clauses in their collaborations has the potential for great success by letting others use the bioprinting platform while limiting the downside risk. Regardless of the study's outcome, ONVO will receive the negotiated payments. If successful, however, vast royalty payments from commercialized products (potential new cancer treatment in this case) will propel the company to new heights. With such a tactic, Organovo takes the position of a broker, with limited risk standpoint yet infinite profit potentials.
A similar approach can be examined with the business model of credit card companies like Visa (V) and Mastercard (MA). Contrary to popular belief, neither Visa nor MasterCard actually issue credit cards themselves, nor do they extend credit to consumers. Neither company deals with consumers or merchants directly. Instead, financial institutions use credit card payment product platforms to develop credit card programs for consumers. These credit card companies make money by charging a fee to merchants for using their network to manage the exchange of information during a transaction. They create value for all stakeholders during the process. Cardholders' benefit because of convenience, security, and rewards associated with card payments. Merchants benefit from improved sales by offering payment method options to the customers. Banks get new revenue streams through card fees, and late payment interests. In other words, as the volume of credit card transactions increase, as do the profits of these companies. Their risk standpoint is minimal as the financial institution incurs the loss if a consumer defaults on debt, instead of the credit card companies which do not deal with debtors directly.
Organovo continues to add value to its shareholders with its recent collaborations that not only validate the bioprinting technology but also divulge favourable risk to reward compensation. Agreements with academia bodies or R&D labs to utilize their 3D bioprinting technology offer Organovo a limitless opportunity of potential with a controlled risk standpoint. Further, similar partnerships will reposition Organovo as a promising public 3D company to be listed in the same domain as current market leaders 3D Systems (DDD) and Stratasys (SSYS).
As the stock price continues to trade over $2.50, investors should keep an eye out for the announcement of remaining outstanding warrants (effects of exercised warrants explained here). Assuming the stock does not see a rapid decline, management should be able to file the warrant call by early February, falling within the next week. Such a scenario would allow management to inquire about up-listing without any evident issues and reward investors with a possible appearance on the NASDAQ CM exchange by Q3 2013.
proinpro : Kursverlauf der letzten Tage
Chalifmann3 : es geht vorwärts ....
In December 2010, Organovo entered into a $600,000 collaborative research agreement with Pfizer (PFE) to develop specific three-dimensional tissue based drug discovery assays in two therapeutic areas utilizing the NovoGen MMX Bioprinter technology. Pfizer has paid the company all $600,000 under the agreement, as Organovo delivered the constructs to Pfizer during the fourth quarter 2012. Constructs delivered by Organovo are currently being evaluated in Pfizer's laboratory. No specific timeframe has been given, but we suspect that Pfizer will come back to Organovo in the next six to twelve months. Ideally, Pfizer and Organovo will sign an additional agreement that expands the relationship at that time. We anticipate any new deal signed will provide an upfront payment, as well as the potential to earn development, regulatory, and sales-related milestones, as well as royalties on commercialized products.
In October 2011, Organovo entered into a $1,365,000 research agreement with United Therapeutics (UTHR) to establish and conduct a research program to discover treatments for pulmonary hypertension using the NovoGen MMX Bioprinter technology. The initial term of the collaboration was for 30 months. However, in November 2012, Organovo and United Therapeutics executed an amendment to the agreement adding additional research scope and providing for additional collaborative research funding. This new expansion of the agreement added $150,000 to the contract. To date, Organovo has recognized a total of $1,100,000 in payments from United Therapeutics. Based on the existing contract, $400,000 remains to be recognized in 2013.
In December 2012, Organovo announced it started working together with Autodesk, Inc (ADSK) to create the first 3D design software for bioprinting. The software, which will be used to control the company's NovoGen MMX bioprinter, aims to represent a major step forward in usability and functionality for designing three-dimensional human tissues, and has the potential to open up bioprinting to a broader group of users.
In January 2013, Organovo entered into a collaboration agreement with the Knight Cancer Institute at Oregon Health & Science University (OHSU), a national leader in translational oncology research, to develop more clinically predictive in vitro three dimensional cancer models which are ultimately expected to advance discovery of novel cancer therapeutics. We are very pleased to see Organovo collaborating with OHSU. The OHSU Knight Cancer Institute is one of the nation's top cancer research centers. The center's director is Dr. Brian Druker, who developed Gleevec for chronic myeloid leukemia at Novartis.
The goal of the collaboration is to marry Organovo's 3D bioprinting technology with KCI-OHSU's deep understanding of cancer and metastasis to develop new therapeutic candidates. Discoveries can then be out-licensed to larger pharmaceutical companies for clinical development. We believe Organovo's 3D bioprinting technology has the ability to improve on animal model and cancer cell lines currently being used to test drug candidates by providing a more representative model of human disease. New biological models that more accurately replicate human cancer and malignant disease could be an enormous opportunity for the company.
In February 2013, Organovo signed a partnership agreement with ZenBio Inc., a leading provider of advanced cell-based solutions and services for drug discovery and advanced tissue therapies. Under terms of the collaboration, ZenBio will provide unique and validated cellular inputs for use by Organovo with its NovoGen bioprinter. NovoGen creates living, three-dimensional tissues that reproduce the architectural and functional features of tissues inside the human body. By partnering with ZenBio, Organovo now has access to a validated supply of cells to build cell assay models for commercialization or for surgical therapies. Potential opportunities may be in creating 3D skin structure assays for cancer therapeutic or cosmetic testing.
Organovo's goal is to sign additional licensing and collaboration partnerships over the next several years, either with leading academic centers like KCI-OHSU that provide knowledge and driver knowhow, or with synergistic partners that can advance the potential to create cell assays or commercial products for Organovo.
…Making Progress With Cell Assay Products…
Organovo's NoveGen MMX bioprinter can produce highly specialized three-dimensional human tissues that can be utilized to model a specific tissue physiology or pathophysiology. The company has demonstrated the ability to create human blood vessel constructs, and to create fully human tissue containing capillary structures. This has the potential to broaden the scope and scale of 3D tissues that can be generated, and to facilitate the development of disease models in such areas as cardiovascular disease, oncology, and fibrosis.
But a more near-term opportunity for the company is in the development of cellular assays to facilitate biological research through absorption / distribution / metabolism / excretion (ADME) testing. ADME testing is used to determine which factors enhance or inhibit how a potential drug compound reaches the blood stream. Many companies perform ADME studies utilizing various cell-based assays or automated bioanalytical techniques. Drug metabolism and pharmacokinetics (DMPK) testing is a subset of ADME. Determining the DMPK properties of a drug helps the drug developer to understand its safety and efficacy. Finally, toxicology (TOX) testing is a further requirement to determine the detrimental effects of a particular drug on specific tissues.
The pharmaceutical industry spends over $50 billion per year on R&D, yet only produces some 30 new drugs that are approved by the U.S. FDA. Many drugs fail in preclinical or clinical testing due to a lack of understanding on physiology or pathophysiology or unforeseen toxicity. This is because currently drug therapy research and testing generally involves testing drug candidates and therapies on monolayer two dimensional cell cultures that attempt to mimic damaged or degenerating tissues. Organovo's technology creates three dimensional cellular structures which enhance and facilitate drug discovery.
We believe that the NovoGen MMX Bioprinter is positioned to deliver highly differentiated products for use in traditional cell-based ADME / TOX / DMPK studies. Products in this arena may replace or complement traditional cell-based assays that typically employ primary hepatocytes, intestinal cell lines, renal epithelial cells and cell lines grown in a traditional two-dimensional format. Organovo's technology may be particularly attractive area for testing liver toxicity, which can be difficult to model in cell culture assays because the cells flatten out resulting in altered gene expression / loss o phenotype. The cells essentially stop functioning as liver cells within 24 hours of culture, no longer producing liver enzymes or biomarkers of activity. A 3D living human tissue makes it possible to test the toxicity of an experimental compound in a way that more closely mimics the reaction within a living organism over a longer period of time.
Importantly, the combination of tissue-like three-dimensionality and human cellular components is believed to provide an advantage over non-human animal systems toward predicting in vivo human outcomes. There is an enormous opportunity for Organovo to launch a liver cell assay kit into the drug discovery market for things like ADME / TOX / DMPK studies. Organovo's 3D tissue-culture system is designed to bridge the gap between preclinical animal modeling and human clinical trials. The process provides a more dynamic and true representation of target drugs interactions in a natural biology.
We expect Organovo to present data on its first livery cell assay product in late April at the Experimental Biology conference. The company is planning multiple poster presentations designed to demonstrate liver histology and biomarker activity. If successful, we expect Organovo to be in position to launch its first products here - such as 48 or 96-well liver toxicology kits - in late 2014. We see this as a potential $20 to $30 million opportunity. Other applications include testing new medications for lung fibrosis and cancer (note the Knight Cancer Institute deal in January 2013), equally large or larger opportunities to the company.
…Balance Sheet Improved…
Net loss for 2012 totaled $43.1 million, or $1.01 per share. Loss included $34.2 million in non-cash derivative charges for increase in the outstanding warrant liability. Operating and investing cash burn in 2012 totaled only $10.1 million, driven by $3.4 million in R&D and $7.1 million in SG&A. Organovo exited 2012 with $14.8 million in cash and investments. The company secured an additional $2.3 million in cash during the first quarter from warrant exercises. The company has dramatically cleaned up its balance sheet. We find the current cash balance sufficient to fund operations into 2014.
…Seeking An Uplisting…
Management at Organovo has said in the past they seek to uplist from the OTCQB to a major exchange. The company even reiterated this goal in a press release on March 19, 2013.
Financial and liquidity listing requirements for the NASDAQ Capital Markets require stockholders equity of +$4.0 million, a market value of publicly held shares of $15.0 million, a market value of listed securities of $50.0 million, 1 million publicly held shares, and a bid or closing price above $2 per share if net tangible assets exceed $2 million and a three year operating history.
Below we look at how Organovo qualifies for listing on the NASDAQ-CM:
(click to enlarge)
Investors can see the company is still shy of the > $4 million Stockholders' Equity requirement by roughly $9.7 million. But this is based on year-end 2012 financials. A company can achieve an increase in Stockholders' Equity by either increasing assets, decreasing liabilities, or a combination of both.
Earlier in the first quarter 2013, the company announced a warrant tender to redeem an additional 2.9 million warrants at $1.00 per share. This redemption period expired on March 14, 2013, and the company announced it has secured an additional $2.3 million in cash. The company exited 2012 with approximately 11.4 million warrants outstanding. This equated to a non-cash warrant liability of $20.6 million. That's a $20.6 million non-cash hit to Stockholder's Equity.
As of March 1, 2013, the number of outstanding warrants have been reduced to 7.4 million. As of March 14, 2013, the number was reported to be 4.5 million. We estimate the outstanding warrant liability projected at the end of the first quarter 2013 will be less than $10.0 million. We forecast the cash position at the end of the first quarter 2013 will be around $15.0 million. Therefore, we suspect that the company will have a Stockholder's Equity on March 31, 2013 greater than the required $4.0 million to meet the NASDAQ-CM requirement. Clearly, Organovo has made enormous progress towards the goal of up-listing.
We see a significant opportunity for Organovo to create 3D cell assays and start introducing them to the market in 2014. We model the launch of one new major cell biology assay kit coming to market every year starting in 2014. We see each product as a potential $20 to $30 million opportunity for the company, and there are probably a dozen products within cell toxicology alone the company can create.
We expect the company's top-line to be lumpy, but eventually take off in a hockey-stick like ramp starting in 2015 or 2016 based on two revenues sources: firstly, early-stage collaborations should start progressing to where Organovo can earn developmental milestones, and second, the company should launch cell assay tests in 2014 and 2015.
We expect costs to remain low as management looks to partner with larger organizations and academic institutions. All this should make Organovo an attractive investment for long-term shareholders. We can justify a market value of $300 million given our estimating financial model. We would chase the stock here, but instead recommend investors use pull-backs to opportunistically establish a position.
Chalifmann3 : Alternative
diese meine Biotechaktie läuft übrigens auch ganz gut,nicht ganz so riskant wie Organovo:
proinpro : Am 22.4. präsentiert
"Organovo develops a platform technology that generates functional human tissues which can be employed in drug discovery, biological research, and as potential therapeutic treatment of damaged tissues. On April 4th, CEO Keith Murphy held a live webcast to update investors on the 3D bioprinting company's operations. Listeners were informed that the company was progressing exceptionally well as it hit evaluation targets with Pfizer (PFE) on the collaborative agreement the two had entered into at the end of 2010. Already having renewed its United Therapeutics (UTHR) contract, this successful Pfizer update indicates that another contract extension should be forthcoming for ONVO and, as a result, continued revenue streams from the partnership. Additionally, the call shed some light on the collaboration with Autodesk (ADSK). The software designer is working on a visual design software program that will make the NovoGen MMX Bioprinter more efficient for broader use. Instead of having to use coding, scientists will be able to employ visual design software (think AutoCAD). This adds a feature of convenience to the revolutionary technology which will open the door to greater expansion possibilities.
The main takeaways from the webcast, however, were regarding the liver cell assays ONVO is currently developing and the announced fiscal year change. Keith Murphy informed investors that major new data will be revealed at the Experimental Biology conference in Boston on April 22nd, when ONVO is scheduled to present. This will be the first public look at how ONVO's 3D printed liver cells are performing. Cell assays provide the company with a potential $500 million market opportunity by 2018 through building kits that can be sold for research. Organovo's printed cells are better indicators than the current conventional 2D gold standard method as they offer better behavior and liver cell function. Due to the CEO's excitement and publicized efforts, chances are the data will be encouraging. Otherwise the company would have been subtle about the upcoming conference. Positive results will validate the research thus far, and propel Organovo one step closer to launching its first product by the end of 2014.
Other exciting news announced was the fiscal year end change from December 31st to March 31st. Organovo's fiscal year will now begin on April 1st and end on March 31st the following year. This change was done in alignment with intentions for uplisting to a more reputable exchange at the earliest opportunity. ONVO can show audited financial statements for 12 months post its merger process, from April 1st 2012 - March 31st 2013. This adjusted timeframe includes the warrant calls that cleaned up the balance sheet, meaning ONVO can meet all financial requirements needed for listing on NASDAQ CM. The company must also add to its board of directors to get a majority independent board before submitting an application. Organovo expects to file an application of uplisting by mid 2013.
The above catalyst dates should prove to make the coming months exciting for Organovo as it continues to pursue the development of its platform technology and financial progress through uplisting."
proinpro : Organovo Describes...