The Mission Report

The MissionIR Report - February 2013

In-depth analysis, timely updates, latest market news

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Market News

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Consumer Sentiment Gains on Fiscal Deal Optimism

Consumer sentiment unexpectedly improved in January as Americans felt Washington's deal to avert the "fiscal cliff" at the beginning of the year boded well for the economy, a survey released on Friday showed.

The Thomson Reuters/University of Michigan's final reading on the overall index of consumer sentiment rose to 73.8 from 72.9 in December, topping economists' forecasts for 71.5.

It also marked an improvement from early January's 71.3 preliminary figure, which had been the lowest level in over a year. Survey interviews were done before data earlier this week showed the economy contracted in the fourth quarter.

The agreement reached in Washington earlier in January averted the full brunt of tax increases and spending cuts that had been set to come into effect. But taxes did increase for some Americans, and a 2 percent reduction in payroll taxes came to an end.

"The payroll tax increase has had a significant impact on spending among lower income households," survey director Richard Curtin said in a statement.

Politicians still face a round of budget decisions in the first half of the year, including large automatic federal spending cuts that are looming as of March.

While the recent negative gross domestic product reading is unlikely to cause a significant downturn among consumers, the spending cuts that are set for next month are "a more plausible candidate," said Curtin.

Consumers were nearly equally split on the economy's prospects in 2013, with 28 percent expecting it to improve and 24 percent expecting it to worsen.

The barometer of current economic conditions eased to 85 from 87, while the gauge of consumer expectations climbed to 66.6 from 63.8.

One-year inflation expectations edged up to 3.3 percent from 3.2 percent, while the survey's five-to-10-year inflation outlook held steady at 2.9 percent.

Unemployment Rate Points to a Steady U.S. Economy

Employment grew modestly in January and gains in the prior two months were bigger than initially reported, supporting views the economy's sluggish recovery was on track despite a surprise contraction in output in the final three months of 2012.

Other data on Friday also suggested the recovery was intact, with factory activity hitting a nine-month high in January on strong new order growth. Consumer confidence perked.

Employers added 157,000 jobs to their payrolls last month and there were 127,000 more jobs created in November and December than previously reported, the Labor Department said.

The closely watched report showed an increase in hourly earnings and solid gains in construction and retail employment. The unemployment rate, however, edged up 0.1 percentage point to 7.9 percent.

"This is actually a really good number when you take into account the net upward revision," said Terry Sheehan, an economic analyst at Stone & McCarthy Research Associates in Princeton, New Jersey.

The Institute for Supply Management said its index of national factory activity rose to 53.1 last month, the highest level since April, from 50.2 in December. That offered hope manufacturing will continue to support the economy.

Coming on the heels of data on Wednesday showing a surprise contraction in gross domestic product in the fourth quarter, the reports should ease any worries the economy was at risk of recession, even though the unemployment rate ticked up.

GDP contracted at a 0.1 percent annual rate in the fourth quarter, largely because of a sharp slowdown in the pace of inventory accumulation and a plunge in defense spending.

A monster storm that hit the East Coast in late October also weighed on output, a drag that should lift this quarter.

"This shows that underneath the surface, the fourth-quarter economy was really pretty good despite all the defense cuts. I think the private sector is leading the way," said Jack Ablin, chief investment officer at BMO Private Bank in Chicago.

Fed officials said on Wednesday that economic activity had "paused," but they signaled optimism the recovery would regain speed with continued monetary policy support. The Fed left in place a monthly $85 billion bond-buying stimulus plan.

Economists polled by Reuters had expected employers to add 160,000 jobs and the unemployment rate to hold steady at 7.8 percent last month.

The Labor Department also published benchmark revisions to payrolls data going back to 2008. It said the employment level in March 2012 was 422,000 higher on a seasonally adjusted basis than previously reported. Average job growth in 2012 was raised to 181,000 a month from 153,000.

Economists say employment gains in excess of 250,000 a month over a sustained period are needed to significantly reduce unemployment.

The share of the working age population with a job has been below 60 percent for almost four years.

All the job gains in January were in the private sector, where hiring was as broad-based as it was in December and declines in public sector employment remained moderate.

Steady job gains could help the economy weather the headwinds of higher taxes and government spending cuts. A payroll tax cut expired on January 1 and big automatic spending cuts are set to take hold in March unless Congress acts.

The goods-producing sector showed a third month of solid gains, with manufacturing employment advancing for a fourth straight month. Construction payrolls increased 28,000, adding to December's healthy 30,000 gain.

Construction jobs are expected to rise further as the housing market recovery gains momentum. Housing is expected to support the economy this year, taking over the baton from manufacturing.

Within the vast private services sector, retail jobs increased by a solid 32,600 jobs after rising 11,200 in December. Retail employment has now risen for seven straight months.

Education and health payrolls added 25,000 jobs in January after employment grew by the most in 10 months in December.

Government payrolls dropped by 9,000 last month after falling 6,000 in December. The pace is moderating as local government layoffs, outside education, subside.

A False Start to Tax Season

The fiscal cliff is still causing headaches for some taxpayers. Technically, the IRS kicked off tax season Wednesday — a week later than expected, as a result of Congress’s 12th-hour deal — but tax pros say it could be weeks before many Americans can actually file their returns.

The various changes to the tax code forced payroll departments to hold off their end-of-year accounting. A fair number of taxpayers still haven’t received their W2s, experts say. Those who need to file Form 8863 to claim credits for higher education won’t be able to file until the middle of February, after the IRS finishes updating its processing systems, officials said Monday. And people claiming residential energy credits, depreciation of property, or general business credits will have to wait even longer — until the end of February at least.

The delays generally mean that early-bird filers who would normally collect tax refunds in January — $3,000 on average — won’t be getting their checks until at least mid-February, says John Hewitt, chief executive of Liberty Tax Service.

Refunds are typically issued within three weeks from the date a return is filed, but some taxpayers will have to wait longer because of an effort by the IRS to crack down on identity theft. The agency says it has more filters in place to help spot possible fraud, and some returns will be getting a closer look, further pushing back the delivery date of those refunds.

And the shorter time frame also means taxpayers getting professional help will find themselves competing for their accountant’s attention. “They’re requiring us to do more work in a shorter period of time,” says Harlan Rose, president of the National Society of Accountants. Normally, Rose is able to prepare some simple tax returns in January before his busiest weeks kick off in February, but this year he lost that calm period — and his clients are already grumbling about the delays, he says.

To be sure, the IRS says the majority of taxpayers, or 120 million households, can start filing now. And 70% of Americans qualify to file free returns, according to the Free File Alliance, a coalition between the IRS and tax-software companies. The IRS is also offering relief to some taxpayers: Farmers and fishermen, for example, won’t be penalized if they can’t file and pay their 2012 taxes by March 1, because of the delay. The famous April 15 deadline, however, isn’t budging.

Cardium Therapeutics, Inc. (CXM)

Cardium Therapeutics announced its Chief Scientific Officer, Gabor M. Rubanyi, M.D., Ph.D., delivered a presentation at the 2013 Phacilitate Annual Cell & Gene Therapy Forum in Washington, DC. The presentation, titled “Optimizing Phase III Trial Design for Generx® (Ad5FGF-4),” outlined the current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis, and the lessons learned during the past decade of the company’s Generx clinical development program.

If you would like to view the presentation, visit http://www.cardiumthx.com/generx.html.

"The presentation yesterday reviewed new techniques that have been implemented to optimize our international Phase 3 ASPIRE clinical study for the Company’s Generx® (Ad5FGF-4) DNA-based angiogenic growth factor drug candidate, including: (1) diagnostic identification of patients likely to be more responsive to angiogenic therapy; (2) new balloon catheter-based delivery methods designed to boost adenovector gene delivery and enhance angiogenic growth factor efficiency; and (3) selection of relevant clinical endpoints which may be useful in future clinical studies and help advance the field of therapeutic angiogenesis,” stated Christopher J. Reinhard, Cardium’s Chairman and CEO.

About Cardium Therapeutics, Inc. (CXM)

Cardium Therapeutics, Inc. is a health sciences and regenerative medicine company focused on acquiring and strategically developing new and innovative products and businesses to address significant unmet medical needs. Comprised of large-market opportunities with definable pathways to commercialization, partnering, and other economic monetizations, Cardium's current portfolio includes the Tissue Repair Company, Cardium Biologics, and the company's in-house MedPodium Health Sciences healthy lifestyle product platform.

The company's lead commercial product Excellagen® topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. In addition to plans to advance the product's commercialization in the U.S. and internationally via strategic partnerships, the company plans to develop new product extensions for additional wound healing applications and is working towards securing approval for marketing and sale in South Korea and through the CE Mark application process in the European Union.

Generx®, Cardium's lead clinical development product candidate, is a DNA-based angiogenic biologic designed to treat patients with myocardial ischemia due to coronary artery disease. Cardium recently initiated its Generx Phase 3 / registration study in Russia. Consistent with its capital-efficient business model.

Cardium is also actively evaluating new technologies and business opportunities. The company utilizes its team's skills in late-stage product development to bridge the critical gap between promising new technologies and product opportunities that are ready for commercialization. Cardium is dedicated to building on its core products and product candidates to continually create new opportunities for greater success. Leveraging the advantages of its capital-efficient, asset-based business strategy, the company provides a diversified and more balanced portfolio of risk/return opportunities with the chief objective of providing long-term shareholder value.

Chanticleer Holdings, Inc. (HOTR)

Chanticleer Holdings recently provided a corporate update on its business, operational initiatives, and roll-out plan. The past two years have been very eventful for Chanticleer Holdings. For 2013, the company is focused on achieving same store sales growth, increasing consolidated gross margin to 62% from 58.2%, increasing overall profitability, and expanding its number of Hooters® restaurants.

The company plans to increase the number of restaurants operating in 2013 to a total of 10 restaurants as compared to 6 total restaurants operating at 2012 year-end. It is expected management will secure a long-awaited site in Rio de Janeiro, Brazil, very soon, as well as open a restaurant in Pretoria, South Africa, in the first half of 2013. To view the full update, visit http://dtg.fm/X6Wn.

About Chanticleer Holdings, Inc. (HOTR)

Chanticleer Holdings, Inc. owns and operates Hooters® branded restaurants in emerging international markets. As one of the most well-known restaurant brands in the world, Hooters has a menu that consists of moderately-priced American bar food and the world-famous Hooters girls. The company has ownership interests in the parent company of the Hooters brand, Hooters of America (HOA), four Hooters restaurants in South Africa, one restaurant in Hungary, one Hooters restaurant in Australia, and the exclusive franchise rights to develop and operate Hooters restaurants in three of the most populous states of Brazil: Rio De Janeiro, Minas Gerais, and Espirito Santo.

The first Hooters® restaurant opened October 4, 1983, in Clearwater, Florida. Today there are more than 430 Hooters restaurants in 28 countries. During its history, Hooters has continued to rank high amongst the industry's growth leaders. The Hooters concept has stayed true to its roots with its beach-themed concept, logo, uniform, menu and ambiance being similar to what existed in its original store, and has proven successful in small-town America, major metropolitan areas, and internationally.

In 2011, Chanticleer (NASDAQ: HOTR; HOTRW), together with a group of major private equity investors, acquired Hooters of America (HOA) and its largest franchisee Texas Wings, Inc. Today HOA is the Atlanta-based operator and the franchisor of over 430 restaurants in 28 countries. Chanticleer has rights to develop and operate restaurants in South Africa, Hungary, and parts of Brazil, and has joint ventured with the current franchisee in Australia, while evaluating several additional opportunities.

Chanticleer's core growth strategy involves expanding the Hooters® brand in emerging markets and other rapidly developing global economies. The rising number of middle class consumers in emerging markets is driving the demand for recognized international brands. Targeting underpenetrated international markets with proven market success, the company aims to achieve consistent, above-average growth rates and favorable financial returns for its shareholders.

VistaGen Therapeutics, Inc.
(VSTA)

VistaGen Therapeutics reported the successful completion of its final Phase 1 safety study of AV-101, a novel orally available prodrug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain. AV-101 has been found to be safe and well tolerated, with favorable bioavailability and pharmacokinetics.

“This important confirmation of AV-101’s safety is the final step in our Phase 1 program for AV-101,” stated Shawn K. Singh, JD, VistaGen’s Chief Executive Officer. “With $8.8 million of funding from the National Institutes of Health (NIH) and outstanding strategic development and regulatory support from Cato Research Ltd., we have successfully completed the required studies enabling Phase 2 clinical development of AV-101 for multiple large market neurological diseases and conditions. In addition, recent data from the NIH suggest that the same neural pathway modified by AV-101 may be useful for treating depression. Launching a broad strategic collaboration to advance development and commercialization of AV-101 is among our key goals in 2013.”

About VistaGen Therapeutics, Inc. (VSTA)

VistaGen Therapeutics 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 once-promising drug candidates that have been discontinued during late-stage preclinical development 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 predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested on humans.

By more closely approximating human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development, VistaGen's human stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development by identifying product failures earlier in the cost curve. According to the Food and Drug Administration even only a ten percent improvement in predicting failure before clinical trials could save $100 million in development costs, which savings ultimately could be passed on to patients.

Using mature human heart cells produced from stem cells, VistaGen has developed and internally validated CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. VistaGen is now focused on using CardioSafe 3D™ to generate up to two new, safer small molecule drug rescue variants every twelve to eighteen months. VistaGen anticipates that these drug rescue variants will be modified versions of once-promising new drug candidates that have been discontinued by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite substantial prior investment and positive efficacy data demonstrating their potential therapeutic and commercial benefits.

 
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