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June 2013
When well-loved theater and television performer Jack Klugman died in December of 2012 at age 90, few people remembered an important role that the actor played in the country’s drug development process. Klugman, who had gained television fame as Oscar Madison in The Odd Couple, and later as a medical examiner in the long running series Quincy, was one of the earliest stars to use his celebrity to effectively drive social causes.
In 1982, Klugman went to Washington and testified before Congress on behalf of the Orphan Drug Act. The idea was to provide various governmental supports to encourage pharmaceutical companies to invest in developing drugs for relatively small medical markets. Few people were aware of the need for such support until an episode of Quincy was broadcast in 1981, showing how many people suffered from diseases that went unresearched because they were considered unprofitable. Klugman was called to testify in support of the Act in 1982, and was instrumental in finally getting it passed in 1983.
Since the Act became law some 30 years ago, it has helped support the development of hundreds of drugs, drugs that have gone on to help countless people, and it continues to serve today. Most recently, Advaxis, a developer of immunotherapies for cancer and infectious diseases, applied for Orphan Drug Designation with the FDA Office of Orphan Products Development for the company’s ADXS-HPV drug.
ADXS-HPV is being developed for the treatment of human papillomavirus (HPV)-associated head and neck cancer. Although such cancers do not get the publicity or funding associated with more common diseases, it is still estimated that there are 50,000 new cases of head and neck cancer in the U.S. annually, with about 15,000 deaths. Situations such as this are exactly what the law was meant to address. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven-year market exclusivity period. The new Advaxis drug is good news for sufferers, with the company’s Chief Scientific Officer, Robert Petit, saying: “We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer.”
For additional information, visit www.Advaxis.com
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GRILLiT was founded on the concept of delivering a fast-casual dining experience with fresh, nutritious home-style cooking. Leveraging more than four decades of experience in the food industry, the founders of GRILLiT established this unique business model to satisfy the ever-increasing demand for delicious and healthy food while providing the perfect ambiance for guest to relax and enjoy great cuisine.
The company sources its ingredients from local and domestic farmers to ensure crisp, fresh produce and grain-fed Angus beef. The cooking techniques and low-sodium recipes employed result in uniquely healthy and delectable meal choices. Using the best possible ingredients, GRILLiT chefs have created an inspiring flavor profile using fresh herbs spices and all-natural marinades.
The management team executing GRILLiT’s business strategy has been carefully assembled to achieve rapid growth and profitability. One of the most recent additions, Rob Elliott, brings more than 25 years of experience in restaurant franchise system development, marketing, branding, and operations. Previously serving as Vice President of Marketing for Little Caesars Pizza, he was instrumental in expanding the number of store locations from 150 to 5,000.
GRILLiT is focused on expanding throughout the southeastern United States and offers nationwide franchising opportunities. Current locations operate in high-traffic shopping plazas and offer American, Asian Fusion, and Latin American food styles. The company’s growth strategy is based on a five-year plan to roll out a total of 79 stores in nine States: Florida, Kentucky, Ohio, New Jersey, New Hampshire, North Carolina, Tennessee, Georgia, and Pennsylvania.
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18
Tue
Tue
Tungsten Corp. (TUNG) High Concentration Tungsten Anomalies Detected at Cherry Creek in Nevada
Tungsten Corp., the domestically focused tungsten developer which has put together a nice land package between their 2.3k-acre Cherry Creek property in Nevada and a second project in Idaho, at the historically-producing Wildhorse Mine property, reported today that analysis of the most recent survey data on Cherry Creek has kicked up a bunch of new, heavily-mineralized areas.
A battery of rock, soil, and stream sediment sampling from the last work phase, parsed by Carlin Trend Mining Services Ltd., over in Elko, shows several targets with high concentrations of tungsten mineralization, and the company is already raring to go for another round of sampling. Plans are to get an even more comprehensive survey worked up during this next phase of field work, set to commence directly, with the primary emphasis being on up-stream or other analytics designed to pin-point the sources of the observed tungsten anomalies.
Concentrations well above the economic threshold of 5ppm detected up-stream of areas located by the survey are extremely encouraging to the company, and TUNG will be eager to expand the basis of their claim at Cherry Creek as sources are identified for the mineralization in what are essentially undocumented areas. There has been some tungsten development in the broader district, with operations stretching back to WW1, but it was all of limited scope and TUNG is sitting on prime territory in the heart of a 36 square mile chunk that has also seen a good deal of gold and silver mining, as well as the mining of some other base metals.
President of TUNG, Guy Martin, was excited by how the survey results show previously unknown and highly anomalous tungsten spikes and conveyed to markets how big the upside could be here. Everyone at the company seems fired up to get at the roughly four new areas during the upcoming work program, and this next phase should produce a much higher resolution image of the tungsten at Cherry Creek, as the sources are identified in much greater detail.
One of the chief anomalies is downstream from a known source and is a perfect case for there being multiple mineralized zones in this one particular area. Returns in the range of 24.0ppm to 31.8ppm from this area offer a solid portrait of the potential for more hot spots in the southeastern quadrant of the claim block and this area will likely be the first stop in the next leg of TUNG’s field work.
In the southwest of the block at Pinenut Canyon, which is virgin territory, from both sides of the canyon’s slopes we have tungsten concentrations in the 9.0ppm to 11.7ppm range, making this an extremely juicy target area with some relative blue sky potential that will have to be looked at closely in this next phase. Up north of Pinenut there is another area of similar grade, with results around 6.1ppm to 7.4ppm and again there are no known historical tungsten prospects or old workings to speak of, meaning the tungsten here is ripe for the picking. The final target on the list is a big basin just east of the claim block’s center that is up-slope from known sources. This last area, despite having no known tungsten mineralization, returned results in the neighborhood of 7.1ppm.
These are all economic grades and TUNG will no doubt be chomping at the bit to start the next phase of their work program at Cherry Creek, especially as mounting restrictions, in the form of trade practices by international suppliers, continue to comingle with attractive upturns in the value of tungsten. Tungsten Corp. knows the score on long-term tungsten market dynamics and is positioning shareholders to capture ROI as renewed interest in domestic production starts to heat up. Tungsten remains an indispensible component for an array of things, but chiefly cemented carbides or hardmetal tools, the backbone of shaping other metals and materials, or making up parts of heavy-duty mining and construction equipment.
To learn more, visit www.Tungsten-Corp.com
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18
Tue
Tue
International Stem Cell Corp. (ISCO) Stem Cell Technology a Game Changer for Regenerative Medicine
International Stem Cell Corp. is focused on treating diseases of the eye, nervous system, and liver by utilizing a new stem cell technology called parthenogenesis. The regenerative technology uses unfertilized eggs, sidestepping the controversial use of embryo stem cells, to address immune-rejection.
Stem cells not only have the ability to proliferate, but also to change (differentiate) into more specialized cells such as skin, liver, or blood cells. Because these “pluripotent” stem cells have the potential to become any cell in the body, they are considered the most powerful stem cells.
The first type of pluripotent stem cells to be studied were embryonic stem cells, though the process is of considerable ethical question because creating embryonic stem cells involves the destruction of a fertilized human embryo.
As an innovative alternative, ISCO has pioneered the development of human parthenogenetic stem cells (hpSCs), which are created by chemically stimulating unfertilized eggs (oocytes) to initiate division (proliferation). hpSCs are one of four of the most commonly used and described classes of stem cells: embryonic stem cells (embryonic SCs), induced pluripotent stem cells (iPS), and adult stem cells (adult SCs).
The parthenogenetic stem cells developed by ISCO are the only class of cells that meet all the criteria considered for therapeutic applications. The company has developed a UniStemCell bank, the life science industry’s first collection of non-embryonic histocompatible human stem cells available for research and commercial use. The company anticipates that in the medium term, revenue could be generated through the franchise of stem cell banks.
For more information, visit www.internationalstemcell.com
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EDAP is a global leader in
therapeutic ultrasound. The company markets its Ablatherm for high-intensity,
focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU
treatment of prostate cancer is shown to be a minimally invasive and effective
treatment option with a low occurrence of side effects.
The company announced today that it received CE Mark (European regulatory approval) for Focal.One, its new and innovative robotic HIFU device dedicated to focal therapy of prostate cancer while preserving patient quality of life. Utilizing a focal therapy approach to target the cancer cells within the prostate gland is gaining wider acceptance in the global urological community.
EDAP’s Focal.One is the first device fully dedicated to the focal approach to prostate cancer therapy. It combines the three essential components to efficiently perform a focal treatment: state-of-the-art imaging to localize tumors with the use of MRI technology combined with real-time ultrasound, utmost precision of HIFU treatment focused on identified cancer areas only, and immediate feedback on treatment efficacy utilizing contrast-enhanced ultrasound imaging.
The CE Mark positions the company’s Focal.One device for full commercialization in Europe and in many other countries. EDAP’s unique and exclusive range of HIFU products offers perhaps the widest array of treatment options to patients with prostate cancer. For additional information about EDAP TMS and its entire product line, please visit www.edap-tms.com or www.hifu-planet.com.
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The Professional Diversity Network, a developer and operator of online networks and job boards for culturally diverse professionals, announced that it has acquired Resunate, a developer of recruiting software designed to connect job seekers, colleges, universities, and job placement companies with specific job postings.
Ressunate’s mission has been to increase the number of successful job placements through candidate provision of insight into how best to present oneself and which opportunities are best suited to the candidate. Through the acquisition, the company has gained a résumé optimization tool that is currently used by job seekers and career services offices in over 150 countries. The resume tool has proven to double an applicant’s interview rate through the use of interactive feedback on how to best tailor a resume for respective positions.
“This technology is extremely effective at securing interviews for our members while at the same time providing our recruitment clients with applications that best fit their criteria,” commented Ayan Kishore, PDN Executive Vice President. “The Resunate platform was developed by top recruitment sector experts, holding graduate degrees from Carnegie Mellon and MIT. This acquisition demonstrates the level of PDN commitment to investing in order to bring career opportunity to millions of diverse Americans and enable employers to recruit diverse talent.”
PDN, as part of the acquisition, will gain immediate access to the intellectual property and technology team of Resunate, ensuring a seamless competitive advantage for its users. As such, PDN’s 2.5 million members and customers, comprised of job seekers, employers, and recruiters, will see a substantial improvement to results. The integration of the Resunate brand and its résumé optimization technology are expected to be merged within the PDN suite of sites by the end of this year.
“The PDN acquisition of Resunate reflects a shared vision and common goals — that of showcasing top talent, and increasing access to desirable jobs for diverse professionals,” stated Mike Hernandez, PDN Chief Marketing & Communications Officer. “We look forward to working with the Resunate team to improve the experience and engagement of our users, with a view toward putting many more talented Americans back to work.”
For more information on Professional Diversity Network, please visit www.prodivnet.com
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18
Tue
Tue
Registered Direct Offering of $12.0 Million Completed by Elephant Talk Communications Corp. (ETAK)
Yesterday, Elephant Talk Communications Corp. announced the completion of a registered direct public offering of an aggregate $12.0 million, which was led by a $4.5 million investment from company CEO Steven van der Velden, a $5.0 million investment from Crede CG III Ltd. (a wholly owned subsidiary of Crede Capital Group LLC) and investors placed by Dawson James Securities to purchase an additional $2.5 million. The company sold an aggregate of 17,425,638 shares of common stock, par value $0.00001 per share, and warrants for purchasing up to an aggregate of 7,841,537 shares of common stock.
The shares are being sold to non-affiliate investors at $0.682 per share and to the affiliated investor (van der Velden) at $0.70 per share. The warrants have an initial exercise price of $0.887 per warrant share for both the affiliated investor and the non-affiliated investors. NYSE MKT notified Elephant Talk Communications on June 13 of its acceptance of the company’s plan of compliance; this was one of the closing conditions of the offering.
The gross proceeds realized by Elephant Talk Communications in connection with the offering are $12.0 million, and the net proceeds are anticipated to be around $11.4 million after deducting the placement agent and estimated offering expenses. A portion of the net proceeds from the offering will be used by Elephant Talk Communications to pay all outstanding obligations of around $6.7 million, pursuant to certain purchase agreements with the holders of certain senior secured convertible notes that the company issued on March 29, 2012. The remaining net proceeds will be used for working capital and other general corporate purposes.
Following this successful closing of the registered public offering, Elephant Talk Communications’ management plans to focus on growing the company’s topline while diligently moving Elephant Talk Communications toward being consistently operational cash flow-positive.
“I believe that the recent fund raisings were an integral component of the NYSE MKT’s decision to accept the company’s plan to regain compliance,” CEO and Chairman van der Velden said. “Using the proceeds to repay existing debt strengthens the company’s financial position by providing liquidity and significantly lowering the company’s outstanding debt. In addition, the company’s recent milestones of nearly reaching a positive cash flow position in March and receiving an additional $1.5 million of funding in May provide very positive momentum moving forward.”
For more information, visit www.elephanttalk.com
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18
Tue
Tue
Cardium Therapeutics, Inc. (CXM) Builds Diverse Portfolio with Broad Commercialization Opportunities
It’s not something you’d expect to find in a regenerative medicine company’s portfolio, but Cardium Therapeutics’ To Go Brands healthy nutraceutical supplement business is complementary to the company’s overarching mission of meeting unmet medical needs as part of an individual’s overall health and wellness.
Cardium in October 2012 acquired the assets, business, and product portfolio of To Go Brands, which develops and markets more than 25 products including nutraceutical powder mixes, supplements, and chews to support healthy lifestyles.
The brand’s Healthy To Go product line offers a host of healthy product offerings distributed through mass food and drug channels at retailers such as Whole Foods, CVS, Kroger, GNC, Vitamin Shoppe, and more.
Within Cardium’s medical opportunities portfolio is its lead commercial product, Excellagen®, topical gel for wound care management. Excellagen is FDA-approved for the marketing and sale in the United States. In addition to its plans to advance Excellagen’s commercial reach in the U.S. and internationally, Cardium plans to develop new extensions for additional wound care applications, and its working to achieve regulatory approval for the marketing and sale of the product in South Korea and the European Union.
The company’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic designed to treat patients with myocardial ischemia due to coronary artery disease. Cardium recently initiated its phase 3 registration study for Generx in Russia.
For more information, visit www.cardiumthx.com or www.togobrands.com
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Indianapolis based franchisor of Noble Roman’s Pizza and Tuscano’s Italian Style Subs, Noble Roman, provided an update today on the continued expansion of its popular take-n-bake (TNB). The expansion currently targets grocery stores around the country as well as market growth of its stand-alone take-n-bake franchises.
The company has signed five new stand-alone TNB franchise agreements in the last two weeks alone, bringing the total number of take-n-bake franchises open or currently in development to 16 total. Of those, seven are currently in operation and open; the other nine are under construction and have tentative openings scheduled during the next several months.
Noble Roman will continue overall expansion efforts, including increasing the number of grocery stores offering Noble Roman’s Take-n-Bake pizza. As of today approximately 1,625 license agreements have been signed. Noble Roman has been steadily expanding its grocery network, promoting additional interest from grocery chains nationwide. Management is set to attend grocery trade shows in order to create awareness and identify market opportunities within the industry, including the International Dairy Deli Bakery Association trade show to take place in Orlando, Florida, this month.
Additionally, Noble Roman continues its steady growth in non-traditional venue areas, adding 22 non-traditional franchise/license agreements in 2013 thus far.
“Take-n-bake continues to be one of the fastest growing segments of the pizza industry,” stated Paul Mobley, Chairman and CEO, Noble Roman’s Inc. “And Noble Roman’s is at the forefront of this trend, methodically increasing our presence in grocery stores around the country and growing our stand-alone TNB franchises. We continue to grow our pipeline of franchise prospects for the stand-alone take-n-bake concept, and expect to have several others under development over the coming weeks. We have signed license agreements for approximately 1,625 grocery stores to carry our TNB product, and expect to add to our grocery network steadily in the coming months. Our new hot pizza by the slice offering has helped us to accelerate our penetration with grocery stores around the country. With our recognized brand and our reputation for great taste and high quality, we are poised to grow our revenues and profitability due to the popularity of the TNB concept.”
Noble Roman’s Take-n-Bake creations are anchored in the chain’s popular hand-tossed style pizzas. Some of those pizzas include Deep-Dish Sicilian and the SuperThin pizza. Noble Roman’s famous breadsticks with spicy cheese sauce are also a great draw. All items are in a convenient cook-at-home format. Additional menu offerings will include cinnamon rounds, fresh salads, cookie dough, bake-able pasta, cheesy sticks, and more.
The company’s current success comes from strategic grocery store licensing agreements to carry Noble Roman’s delicious take-n-bake pizzas. The Noble Roman stand-alone take-n-bake unit requires only 900 square feet with minimal equipment, resulting in a much lower investment cost. In addition the take-n-bake units require less labor and generate lower operating costs such as utilities, making it an affordable franchise for many to operate.
To learn more, visit www.nobleromans.com
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