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Ray Dirks has been a respected analyst on Wall Street for decades. Ray has written two books,” The Great Wall Street Scandal” and “Heads You Win, Tails You Win”, published by McGraw-Hill and Bantam Books respectively. Dirks opened his own securities analysis firm after gaining much attention in... More
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  • Pluristem Chosen For Accelerated Marketing Approval In Europe

    Potent game-changing medicine is what makes Pluristem Therapeutics (NASDAQ:PSTI) a home run stock in the biotech sector, and they are now recognized by a European regulatory powerhouse that will propel them closer to marketing approval.

    Just this week, Pluristem was selected by the European Medicines Agency (EMA) in its new Adaptive Pathways pilot project for fast-tracking placental-derived PLX cells in critical limb ischemia (CLI), or leg artery blockage often leading to amputation and death. Adaptive Pathways, much like the FDA's Breakthrough Designation, would allow drugs to get to market sooner than lengthy, expensive and big Phase III trials. Pluristem finished a Phase I trial in CLI with good results. With the EMA program, approval to sell PLX cells could come as early as the end of a Phase II study.

    CLI is a huge market - $12 billion globally. According to experts at SAGE Group, three million Europeans have CLI. Driven by an aging population, this number is projected to grow to four million by 2030. That's almost 35% in just 15 years! No wonder the EMA wants an answer to this pervasive problem.

    Based on research conducted by my team, getting into Adaptive Pathways makes Pluristem ahead of other cell therapy companies and first in line to get Europe's regulatory green light. A gigantic win for Pluristem, putting them in the lead of regenerative medicine while altering the landscape of biotechnology itself.

    Looking back, an April 1st Reuters article by European pharmaceuticals, biotechnology and healthcare correspondent Ben Hirschler stated that 58 drugs had been submitted to the EMA for the Adaptive Pathways project and only eight were selected for a second stage of screening. Reuters' Hirschler writes that, "The EMA declined to identify specific drugs or companies involved but an official said the first stage II meeting on April 7 would concern an advanced therapy product, meaning it is a medicine based on genes, cells or tissue engineering." We think the April 7 meeting was favoring Pluristem and the EMA clearly liked what they saw. Now this is confirmed!

    As an 'off-the-shelf' product, PLX cells offer huge advantages over other cell therapies in the works developed by large and small drug companies alike. They come from the human placenta, usually discarded after a healthy, full born birth. Pluristem's patented, fully automated cell expansion methods at its state-of-the art manufacturing facility are capable of very cost-effectively producing 150,000 doses of PLX cells annually. Better yet, Pluristem's cells do not cause an autoimmune reaction and can be given to anyone. The cells treat different diseases by sensing where the body needs repair, and then healing through a systemic effect. After all of our years of research, we believe Pluristem has the perfect cell therapy.

    Japan, one of the largest consumers of pharmaceuticals and world-renowned for interest in cell therapy, has a fast-track approval process in place - the Accelerated Pathway for Regenerative Medicine - and Pluristem's PLX cells are a part of it. That makes two important medical territories the company can sell into quickly.

    Acceptance of PLX cells into the Adaptive Pathways for CLI makes Pluristem a hugely desirable partner. Pluristem already has partnerships in place, including United Therapeutics (NASDAQ:UTHR) with an $8 billion market cap, but Pluristem's dance card if far from full. On the other hand, with $42 million in cash and equivalents on its balance sheet, Pluristem is very well positioned to go this alone and pay for a Phase II trial with its own funds.

    Investors should remember, Pluristem's success in early trials has led it to conduct a Phase II in intermittent claudication, a disease that often leads to CLI, with clinical sites all over the world. PLX cells have also shown strong efficacy in a Phase I/II muscle injury trial that concluded in Germany in 2013, with more studies planned.

    The impact of this latest news is big for Pluristem, its investors and its pharma partners. Beyond the potential benefit to patients, trends toward accelerated approvals will shift the valuation of innovative biotechs like Pluristem who have a pipeline of drugs that Big Pharma needs and constantly hunts for. Being just one successful trial away from commercialization should completely change Pluristem's ridiculously low valuation of under $200 million (the current market cap) now, and propel the company to newer heights of not only value, but recognition as the worldwide premier cell therapy company that it is.

    RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

    May 19 3:37 PM | Link | Comment!
  • The Next Big Players In Mobile Health: Apple Watch And Dario

    The market for mobile health monitoring and diagnostics is projected to reach $8 billion by 2019. Two key players in this market are Apple (Ticker:AAPL) with its Apple Watch and LabStyle Innovations (Ticker: DRIO), maker of the Dario Diabetes Management System. This emerging market for small, sleek and often wearable devices that function as mobile healthcare diagnostic devices was estimated at a mere $650 million in 2012. It has been dominated by cardiac monitors that work in conjunction with smart phones. According to Transparency Market Research, the market is expected to grow at a CAGR of 43%, led by growth in the mobile glucose monitoring segment. This is where LabStyle comes in with the Dario.

    Although the market may appear to be small for a giant like Apple, the technology innovator may be looking at the wider $3 trillion U.S. healthcare market and strategizing how to serve part of this market through the data that the Apple Watch is now capable of gathering. Diabetes is one disease that is on Apple's list, according VP of Operations, Jeff Williams. Diabetes is one of the largest patient-generated data sets, lending itself to benefit from the potential of mobile health devices.

    Apple Watch comes with a heart sensor, accelerometer, and activity monitor, all designed to promote health. Apple is not yet claiming that the Watch will play a part in monitoring, diagnosing, or treating serious diseases, however, the company appears to be making moves in that direction.

    On April 14, Apple announced the availability of ResearchKit™, a software framework designed for medical and health research that helps doctors, scientists and other researchers gather data more frequently and more accurately from participants using mobile devices. Apps already available on ReserachKit study Parkinson's, diabetes, heart disease and asthma among others. Massachusetts General Hospital, Stanford University, and the Dana-Farber Cancer Institute are among the organizations that have played a role in developing these apps. ResearchKit follows Apple's launch last year of HealthKit, a software platform that collects and merges data from different health and fitness apps.

    While stand-alone apps for diseases including diabetes exist, LabSytle Innovations' Dario Diabetes Management System is the only one that combines an all-in-one blood glucose meter, smart phone application for Apple and Android devices, and website application with treatment tools to support more proactive and better informed decisions by patients, doctors and healthcare systems. Dario provides patients, caregivers and clinicians both real-time and historic patient data resulting in better patient performance and improved health.

    The Dario is about to transform the daily management of diabetes. Further integrating the Dario with the Apple Watch seems to be an obvious opportunity for Apple and LabStyle to gather even more data that can help diabetics better and more independently self-manage the disease. The global blood glucose monitoring market is expected to reach $12 billion by 2017. More self-management may lead to fewer hospital visits and put a dent in the cost of diabetes management in the U.S., which was $245 billion in 2012.

    The Dario is currently awaiting FDA approval, expected in 2015. It has already been approved and launched in Europe, the UK, and Australia. According to the International Diabetes Federation, every seven seconds a person dies from diabetes. Technology from companies like Apple and LabStyle may play a role in improving and prolonging the lives of people living with the disease.

    RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

    May 10 5:25 PM | Link | Comment!
  • CEL-SCI Is A Rare Value Opportunity In Cancer Immunotherapy Stocks

    Cancer immunotherapy is scorching hot. At no time in medical history has a new cancer treatment been so widely researched and highly paid for. Over the last 50 years, the only medicine for cancer has been radiation and chemotherapy, and a few monoclonal antibodies with side effects not much better, barbaric compared to this new wave of ways to combat the disease.

    Leading this charge is CEL-SCI Corporation (NYSEMKT:CVM), far above competitors, in Phase III clinical trials with Multikine, a potent cocktail of immune system activators for head and neck cancer (and other infectious diseases). After a misstep with an incompetent contract research organization (CRO) to run studies, the company regrouped and hired two global oncology experts - Aptiv Solutions and Ergomed, the latter which, also serving multi-billion dollar Sanofi (NYSE:SNY), will contribute up to $10 million to the development of Multikine for its cancer indication in exchange for a very small royalty payment when the drug is approved and on the market. I credit the savvy of Cel-Sci's CEO, Geert Kersten, long-time advocate of the technology, for inking this terrific deal.

    Ergomed, true to a unique model for filling clinical trial beds, helped Cel-Sci report its third consecutive month of record patient enrollment so far this year in the head and neck cancer study, bringing the total to over 400. Cel-Sci's goal is 880 subjects and looks on track to complete this number by year end. The latest clinical center to join the trial is Aintree University Hospital in the UK, led by a specialist in head and neck cancer from a prestigious facility in Liverpool, bringing on board another country very close to the company's goal of 100 clinical sites in 25 countries.(click to enlarge)

    Investors should be impressed. The Multikine Phase III study is aimed at patients with advanced head and neck cancer, but not yet treated, a more difficult pool to choose from. Head and neck cancer, a horribly disfiguring disease, inflicts 600,000 new people worldwide every year and accounts for almost 10% of new cancer cases in the US. Globally, the market size is $3.2 billion. There is a clear need for alternatives to scarring surgery, not to mention the devastating effects of standard chemotherapy.

    Multikine's clinical trial endpoint is a 10% improvement in overall survival with subjects treated with the drug versus standard of care, not a hard hurdle to meet. When accomplished, approval applications for Multikine can be made in all the countries where clinical trials are held, giving Cel-Sci a wide global reach for upcoming sales.

    With a market cap of just $85 million, CEL-SCI is blatantly undervalued as a Phase III cancer immunotherapy company. Look at recent transactions for cancer immunotherapy: Cellectis SA (Pending:CLLS), an IPO backed by high-powered underwriters, recently raised nearly $230 million and stands with a market cap of $1.1 billion, spurred to new heights with an up-front payment from Pfizer, Inc. (NYSE:PFE) of $80 million.

    Juno Therapeutics (NASDAQ:JUNO), another newcomer in cancer immunotherapy barely out of Phase I, took investors for $265 million last year. Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), in early trials went public at $140 million with a current value of $681 million. Kite Pharma, Inc. (NASDAQ:KITE), another recent public offering, trades at a $2.8 billion market capitalization, based solely on an early-stage cancer immunotherapy hopeful, in head and neck cancer.

    A close peer to Cel-Sci, Inovio Pharmaceuticals (NASDAQ:INO) doing studies in head and neck cancer caused by human papilloma virus (HPV) and only in Phase I/IIa boasts a valuation of $609 million. ImmunoGen, Inc. (NASDAQ:IMGN), early in Phase I for head and neck with a cancer immunotherapy, has investors paying $10 per share with a market cap of $871 million. Transgene SA (TNG.PA:Paris) is enrolling for Phase II in HPV-induced cancer, developing a vaccine for head and neck - market cap is $230 million.

    ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP) is in Phase II with immunotherapy for solid cancers with a value of $1.2 billion. Puma Biotechnology (NYSE:PBYI), in various stages of clinical trials with one drug, PB272 for breast cancer, is valued by investors at $7.4 billion. Celldex Therapeutics (NASDAQ:CLDX), in mid-stage trials for brain cancer using immunotherapy would, if successful, sell to a market much smaller than Cel-Sci's yet is valued at $2.4 billion.

    Big Pharma is throwing big dollars around for cancer immunotherapy. Bristol-Myers Squibb (NYSE:BMY) pays $800 million for privately-held Flexus Biosciences with milestones leading up to $1.25 billion, and struck a deal with Rigel Pharmaceuticals (NASDAQ:RIGL) for exclusive rights to develop drugs from Rigel's technology to inhibit tumor growth, costing Bristol around $340 million. AbbVie Inc. (NYSE:ABBV), spun off from Abbott Laboratories (NYSE:ABT) agreed to buy Pharmacyclics Inc. (NASDAQ:PCYC) for a stake in their new cancer immunotherapy drug Imbruvica, at an astounding $21 billion.

    Multinational giant Johnson & Johnson (NYSE:JNJ), the Band-Aid and Tylenol company, and Novartis AG (NYSE:NVS), known best for its diabetes products, both backed cancer immunotherapy purveyor Aduro Biotech (Pending:ADRO) for a recent IPO that sent the stock soaring at its opening, priced at $17 and opening at $32.

    Cel-Sci has been unfairly ignored in this race for cancer immunotherapy drugs. This stock has seen momentum and I expect more. In early March, shares jumped when the company announced record patient enrollment in February, with volume 200% above average trading. Cel-Sci's news keeps getting better. Besides head and neck cancer, Multikine drew attention from the US Naval Medical Center in San Diego resulting in a deal under the government's coveted CRADA (Cooperative Research and Development Agreement) to study the drug for sexually transmitted disease - apparently a big problem in the armed forces. The University of Maryland also investigates these conditions for Cel-Sci in a Phase I trial. All said, this company has a broad reach for its potential to work with the body's immune system to attack tumors.

    Success in any of Cel-Sci's clinical trials for Multikine, a pivotal-stage cancer immunotherapy drug, could reward the stock with a huge jump in hundreds of millions of dollars in valuation.

    RAY DIRKS suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

    Apr 23 1:38 AM | Link | Comment!
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