The Mission Report

The MissionIR Report - November 2011

In-depth analysis, timely updates, latest market news


Market News

Company Updates


No Bold Moves Expected from Fed as Economy Shows Gains

The message from the Federal Reserve when its two-day policy meeting ends will likely be "let's wait and see." Few expect any major new steps to be announced.

Fed policymakers likely want to gauge the impact of action they've taken recently to keep interest rates low. The Fed has breathing room because the economy and stock markets have strengthened enough to help relieve fears of another recession.

After their September meeting, the policymakers said they would shuffle the Fed's investment portfolio to try to further reduce long-term interest rates. And in their previous meeting in August, they had said they plan to keep short-term rates near zero until at least mid-2013 unless the economy improved.

"They know they are running out of tools, so they don't want to employ another one unless they have to," said David Wyss, former chief economist at Standard & Poor's.

At its last meeting, the Fed left open the possibility of taking additional action to try to help the economy. One option is to further explain the steps it has already taken and their purposes. Another would be to launch a third program of bond purchases.

But the Fed remains deeply divided over what, if any, action to take, which is another reason economists don't expect any major announcements this week.

The actions taken in August and September were adopted on 7-3 votes, the most dissents in nearly 20 years.

Three regional bank presidents -- Richard Fisher of Dallas, Charles Plosser of Philadelphia and Narayana Kocherlakota of Minneapolis -- all voted no. They have expressed concerns that the Fed's policies could lead to high inflation later.

On the other hand, four policymakers are worried that the Fed might not be doing enough. Vice Chair Janet Yellen, Governor Daniel Tarullo, Chicago Fed President Charles Evans and New York Fed President William Dudley have said the economy is at risk and might need more support.

"I have never seen the Fed more deeply divided than it is at this moment," said David Jones, head of DMJ Advisors and the author of books on the Fed.

At its meeting in September, the Fed stopped short of expanding its portfolio of investments. Instead, it opted to shuffle $400 billion of its investments to try to lower long-term rates.

But two officials pushed for bolder action, according to minutes of the meeting. The members discussed more bond-buying. Some said it should remain an option.

A brighter outlook for the economy has given the Fed more room to wait. The economy grew at an annual rate of 2.5 percent in the July-September period -- the best quarterly performance in a year.

That's strong enough to show that the economy isn't about to slide into recession. Still, growth would have to be nearly twice as high -- consistently -- to make a major dent in the unemployment rate, which has been stuck at 9.1 percent for three straight months.

Stocks have rallied of late. Even after a drop of nearly 2.5 percent Monday, the Standard & Poor's 500 stock index in October notched its best one-month showing since December 1991.

Many economists think the Fed will hold off on new action until its December meeting or early next year. The next step could be further clarity on its interest-rate policy.

The Best 5 Ways to Lose Money in the Market

Wall Street, blogger/advisor Josh Brown recently put out a list of mistakes that are surefire money losers that you don't need to make, "since he has made almost all of them" himself already. They're moves he describes as being destined to lose before you even embark. Here are his top 5 money losers.

(1) Holding the top spot on the list is: Buying Out of the Money, Naked Options. According to Brown, unless you are an "elite, professional trader" you have no business trying to move money from the pits of the CME to your account, especially since the vast majority of contracts expire worthless.

(2) Another certain money-loser, and a particularly timely one, is the mistake of allowing your politics to cloud your financial judgment. "This is the (mistake) that I see more people do than almost anything else," Brown says. "It is a guaranteed money-loser." It is probably one of the most difficult rules to follow given how Washington-centric and policy driven our markets and economy have become, but agree with basic premise that political approval/disapproval doesn't correlate with gains/losses in the market.

(3) A third costly trap is the ''gut trader" or what most people might call, talking heads. "You need to recognize that you're not listening to an expert on a stock per se," Brown says, adding that it's probably just someone who read something, has excellent recall, and is good at spitting it out. Following the generic ideas of other people is a money-loser.

(4) Brown also offers caution on following the generic timing advice of other people that is not suited to your particular needs and objectives. "Stay away from any of this wild stuff because truthfully, most of the game is just staying with it," Brown cautions. The time frame trap is particularly dangerous in the era of 24-hour media, where live broadcasts, blogs, tweets and other updates can occur in the blink of an eye, and the guru who you thought you were following, may have just changed their mind unbeknown to you. "They're not going to text message you and say, 'time to come out.'"

(5) And finally, don't always look to swim against the tide or to zig when the market zags. "Knee-jerk contrarianism" is a money-loser because most of the time "people are better off in the herd," Brown says. "Only at major turning points" does it pay to be contrarian. Simply taking the opposite side on every investment decision because you consider yourself a contrarian is a money-loser.

There are other tricks and traps to avoid, but if you were to come up with a simple guide to avoid other mistakes, it might be comprised of simply doing your own thinking, setting your own plans, and avoiding anything that you don't fully understand.

VistaGen Therapeutics, Inc. (VSTA) Holds Key Position in Pharmaceutical Marketplace

VistaGen Therapeutics is center stage in one of the most important developments in recent history for the pharmaceutical industry. The California biotechnology company is set to use stem cell technology to transform the way new drug candidates are developed by allowing preclinical drug testing on actual human cells, which is believed to be far more clinically relevant than the current animal testing paradigm.

VistaGen's revolutionary bioassay system can help pharmaceutical companies avoid spending years and millions of dollars developing and testing a new drug, only to find out in late-phase human tests that the drug is toxic to the heart and has to be discontinued. It's one of the industry's biggest fears, largely because it is such a common event. Approximately one third of potential new drugs fail in preclinical or clinical trials due to heart safety issues. It's a major concern for the rest of us as well, since it significantly slows the development and approval of new drugs.

VistaGen uses advanced stem cell technology to grow specialized mature human cells which can then be used to create novel bioassay systems for superior predictive toxicology. Companies and researchers can learn early on if a drug needs to be modified to reduce heart safety hazards, saving huge amounts of time and money, and giving the drug a solid chance of making it to market. In addition, past candidates that have been shelved for heart toxicity concerns can now be cost effectively re-evaluated in the lab, allowing the development of safer variants.

VistaGen's "human clinical trials in a test tube" technology gives the company many unique advantages in the marketplace:

  • Proprietary differentiation of human pluripotent stem cells into mature cells
  • Mature cells available for drug rescue, drug discovery, and cell therapy
  • Drug rescue leverages prior investment on shelved drugs
  • Opportunity to build a pipeline of drug rescue variants
  • Numerous cell therapies, including heart, liver, and cartilage repair

For additional information, visit the company's website at

Neoprobe Corp. (NEOP)

During the most recently ended quarter, Neoprobe sold its neoprobe® GDS line of gamma detection device systems to Devicor Medical Products, Inc. The company recorded a net gain of approximately $25 million (not including potential future royalties that could add up to an additional $20 million), ending the quarter with cash of $31.8 million. Proceeds from the sale provide Neoprobe with a strong balance sheet with which to execute its business plan and support future growth and development.

Other notable milestones achieved by Neoprobe so far this year include listing its common stock on the NYSE: Amex Stock Exchange, securing analyst coverage from several major Wall Street firms, completing a successful pre-investigational new drug meeting for RIGScan with the FDA, announcing top-line data from the NEO3-09 clinical study with all primary and secondary endpoints achieved, and initiating strategic repositioning and rebranding activities of the company as a pure-play radiopharmaceutical developer.

About Neoprobe Corp. (NEOP)

Neoprobe Corp. has quickly risen to dominate in ILM (intraoperative lymphatic mapping, a minimally invasive lymph node biopsy) cancer surgery markets as the only gamma detection systems developer which simultaneously is refining both its radiotracers and detection hardware. Additionally, the Company has a rapidly growing investigational initiative program focused on innovative radiotracing agents and ACT, or activated cellular therapies, under majority-owned subsidiary, Cira Biosciences, Inc.

Among the detection systems, probes and ancillary devices marketed by NEOP worldwide is a wide variety of wired/wireless options for what has become recognized as a vitally important procedure for cancer patients, where the lymph node tissues can be more easily examined for the spread of cancer. The Neoprobe® GDS gamma detection system is at the heart of the GDS Console developed by the Company as well, which was engineered from the ground up to deliver a zero-calibration, highly-customizable and easy to use all-in-one console, enabling speedy work by healthcare professionals. The GDS Console is able to display multiple radionuclide windows at the same time and is instantly user selectable so multiple users can use it without a problem or having to slow down.

Because solid tumor cancers most often spread via the lymphatic system to other tissues, the ILM procedure has become more and more a de facto standard approach. ILM involves using a tracing agent which is then detected, and because the Company has such a strong portfolio of competencies in detection technology, the tracing agents developed under the investigational initiative are finely tuned to the hardware used for detection, resulting in superior performance.

The Company's proprietary radioactive tracing agent Lymphoseek® is secured via an exclusive worldwide license agreement with UC San Diego and is ideally suited for ILM. Activated cellular therapy technology has wide ranging applications as well, with deep impact in patient-specific oncology and diseases of the autoimmune system, or with viral infections like HIV/AIDS or hepatitis. The Company's RIGScan CR system fuses a patented hand-held detection probe and proprietary radio-labeled targeting agents that are cancer-specific, thus allowing surgeons to achieve extremely thorough removal of cancer tissues and better patient results.

Ventrus Biosciences, Inc. (VTUS)

In most recent news, Ventrus Biosciences announced the launch of the first Phase III trial of VEN 309 for the treatment of hemorrhoids. Enrollment opened at 65 of the 70 sites that will participate. The Phase III trial of VEN 309 has been designed to include approximately 600 patients in a double-blind, 3-arm design.

"We are excited to begin the pivotal Phase III trial for VEN 309 for the treatment of hemorrhoids, as planned," stated Russell H. Ellison MD, Chairman and CEO of Ventrus, "particularly as this is the first Phase III trial in the U.S. for a drug treatment for patients with this condition, for whom there are currently no FDA-approved prescription drugs available."

About SEFE, Inc.

Ventrus Biosciences, Inc., a NY-based pharmaceutical developer, while still development stage, has assembled a strong portfolio of product candidates targeting the late-stage prescription market, specifically in the gastrointestinal disorder area. A massive, underserved market of some 12.5M people in the US alone suffer from symptomatic hemorrhoids, with another 7M fecal incontinence and 4M in the anal fissure category, yet no US FDA approved prescription treatments for these conditions appear in the market.

Ventrus Biosciences is working on three platforms to address this market. Iferanserin (VEN 309 – lead product), which is an NCE (new chemical entity) ointment in late stage development (Phase III), engineered for twice-daily topical treatment of hemorrhoids and highly selective, antagonistic targeting of the serotonin receptor associated with the disease (5-HT2A). Phenylephrine (VEN 308), a gel formulated to treat fecal incontinence, specifically that type associated with post colectomy surgeries involving an IPAA (ileal pouch anal anastomosis). Diltiazem (VEN 307), a topical cream for relief of the chronic pain associated with small, extremely painful tears in the tissue the lines the anus, which often require surgery.

In each category VTUS has devised a solution that is either superior to existing offerings out rightly or highly preferable to existing offerings, as in the case of Diltiazem, which has been used for decades in hypertension/angina to dilate blood vessels, where the only alternatives are either minimally effective or require surgery. The market potential in North America alone is substantial and with no FDA-approved competition on the horizon, VTUS stands poised to capture both the market momentum and territory.

VistaGen Therapeutics, Inc.

Vistagen Therapeutics recently announced the publication of original research funded by the company that identifies an antibody useful in the identification and purification of cardiac progenitors and cardiomyocytes. Through its long-standing collaboration with Dr. Gordon Keller, who is also Chairman of the Company's Scientific Advisory Board, and a license agreement with the University Health Network, VistaGen has exclusive worldwide rights to intellectual property arising from this research.

Dr. Ralph Snodgrass, President and Chief Scientific Officer of VistaGen, stated, "The identification and use of the SIRPA antibody permits us to select the very earliest human cardiac progenitors, as well as mature cardiomyocytes, and study the important role of non-cardiomyocytes in the function and maturation of cardiomyocytes. Using this antibody, we can produce human cardiomyocytes with greater than 95% purity, without genetically modifying the cells and without antibiotic selection, which is a significant step forward for our cardiotoxicity bioassay system, CardioSafe 3D™, and our cell therapy initiatives."

About VistaGen Therapeutics, Inc.

VistaGen Therapeutics, Inc. is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of promising drug candidates that have been discontinued during preclinical development ("put on the shelf") due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.

VistaGen's versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant indications, or predictions, of potential toxicity of new drug candidates before they are ever tested on humans. VistaGen's human pluripotent stem cell-based bioassays more closely approximate human biology than conventional animal studies and nonclinical in vitro techniques and technologies currently used in drug development.

Using mature human heart cells produced from pluripotent stem cells, VistaGen leveraged its Human Clinical Trials in a Test Tube™ platform to develop CardioSafe 3D™, a three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. The Company now plans to leverage CardioSafe 3D™ to build a pipeline of new, safer, variants of promising drug candidates that have been "put on the shelf" by pharmaceutical companies because of toxicity concerns, despite positive efficacy data signaling their potential therapeutic and commercial benefits.

VistaGen is also developing LiverSafe 3D™, a predictive liver toxicity and drug metabolism bioassay system, and is preparing to initiate pilot preclinical development of cell therapy programs focused on autologous bone marrow transplantation and heart, liver and cartilage repair. Each of these development programs is based on the proprietary human pluripotent stem cell differentiation and cell production capabilities of the Company's Human Clinical Trials in a Test Tube™ platform.


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