By Jason Napodano, CFA

We are initiating coverage of Neuralstem Inc. (CUR) with an Outperform rating and $3.00 price target. We believe the companys dual-technology platform focused on cell therapy and traditional pharmaceutical products provides investors with the best of both worlds an early-stage investment in a potentially revolutionary pipeline in regenerative medicine and an attractive and under-valued small molecule pipeline sure to attract interest from larger pharmaceutical partners given the novel mechanism of action and broadapplication potential into multiple indications.

Neuralstems cell therapy technology enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain and spinal cord. Neuralstems technology was created to assist the body in producing new cells to replace malfunctioning or dead cells as a way to treat disease and injury. The companys preclinical research shows these cells both help create new circuitry (neurogenesis) and express factors that protect existing cells (neuroprotective). We believe this platform may be useful in treating many diseases and conditions of the central nervous system (CNS) and neurodegenerative disorders. The lead development programs are currently focused on amyotrophic lateral sclerosis (ALS) and spinal cord injuries (SCI).

Preliminary data from the companys phase 1 clinical trial in ALS (abstract / poster) shows encouraging trends in both safety and efficacy. In this trial, the company is injecting human spinal stem cells (HSSC) directly into the gray matter of the spinal cord. This is no easy task. Management licensed a floating injection platform technology from the Cleveland Clinic that allows the injection of the cells into the spinal cord without risk of trauma. Neuralstems Spinal Cord Delivery Platform and Floating Cannula are being utilized in the current phase 1 ALS program, but have the potential for use in additional clinical applications where injection directly into the cord is needed or advantageous, including spinal cord injury. We believe the Floating Cannula technology alone nearly supports the current market value of only $55 million. Now that safety and feasibility have been demonstrated, if Neuralstem were to spin-out this technology into a separate company, we think given the potential to out-license or commercialize with other companies looking to do direct injections into the spine, it would be worth $25 to $50 million in value.

The phase 1 trial is now progressing into the next six patients, all of which will have direct injections into the cervical spine. The previous twelve patients all had injections into the lumbar spine. The FDA wanted to make sure that the safety and adverse event profile was acceptable before progressing into areas of the spine that affect breathing and upper limb function. So far, three patients have been dosed in the cervical spine with no serious complications. We are excited to see the first efficacy data points in approximately six months.

Neuralstem and the FDA are currently in discussions on potentially expanding the phase 1 program, right now capped at 18 patients, into an additional 9 patients bringing the total to 27 that will include reinjecting patients from previous cohorts and increasing the number of cells per injection from 100,000 to 200,000 or 300,000. We think the more data the company can amass from this phase 1 / 2 program, the better chance the FDA will allow movement into a registration program in 2014. The FDA has already granted Neuralstem Orphan Drug designation for ALS. The FDA allowing Neuralstem to move into phase 3 in 2014 is comparable to Fast Track development status. We see the ALS market as wide open. If successful, Neuralstems HSSC for ALS would be a very attractive treatment option for patients with little hope to date.

We have built a sales model for HSSC in ALS that assumes a U.S. filing in 2016 and approval in 2017. Depending on the magnitude of the efficacy, we think Neuralstems HSSC could capture 15% to 20% market share of the vastly underserved 30,000 U.S. ALS population. We think as many as 50% of these patients could be eligible for Neuralstems HSSC treatment. Our model assumes that Neuralstem commercializes HSSC on its own at a price of approximately $100,000 per treatment. With 20% market share, we see the opportunity for Neuralstem at approximately $300 million (30,000 x 50% x 20% x $100,000).

Given the current market capitalization at only $55 million, we think there is little to no value being assigned to the companys novel oral small molecule platform. Neuralstem has developed the ability to screen and test small molecules on living human neurons in vitro. The companys research into hippocampal atrophy as it relates to neurodegenerative diseases such as major depressive disorder (MDD) and Alzheimers disease (AD) has allowed the company to be granted patents on four first-in-class chemical entities.

The first of these oral small molecule compounds to enter human clinical testing is NSI-189. Preclinical data suggests that NSI-189 significantly stimulates the generation of new neurons (neurogenesis) in vitro and in animal models. The data demonstrates clear evidence of increased hippocampal volume in animals with a model of depression. Neuralstem believes NSI-189 has the potential to reverse the hippocampal atrophy associated with major depressive disorder and other related disorders, and to restore fundamental brain physiology. NSI-189 has the potential to address directly the pathology of the disease itself. This is a major paradigm shift from the traditional oral serotonin or norepinephrine molecules currently approved to treat depression and bipolar disorder.

We think if positive, Neuralstem will seek to strike a development and commercialization partnership on NSI-189 in 2013. We believe that management will be seeking enough cash from partnering NSI-189, and additional hippocampal neurogenesis / neuroprotectant molecules can be brought into the clinic. We expect that milestones on the development of NSI-189 will help fund the pivotal registration trials in ALS or SCI in the companys stem cell pipeline. This is a unique opportunity that many of Neuralstems competitors are lacking the ability to self-fund a potentially revolutionary breakthrough in stem cell technology through the advancement of a traditional small molecule platform.

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CUR – Initiating Coverage of Neuralstem, Inc.

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today reported that the cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration.

The study was conducted as part of the European Commission’s Seventh Framework Program (FP7) in collaboration with Prof. Doctor Carsten Tschope and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany.

Dr. Tschope said, “Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction. This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies.”

Diabetes was induced in thirty-six mice resulting in the development of diastolic heart failure. After seven days, the animals received either PLX cells from two separate batches or placebo (12 subjects in each of the three groups). Ten mice were not treated (controls).

After three weeks, several cardiac parameters were assessed and found to be significantly improved following the treatment with PLX cells. Important measurements included the cardiac ejection fraction and the left ventricular (LV) relaxation time constant, believed to be the best index of LV diastolic function and a determination of the stiffness of the ventricle. Cardiac ejection fraction improved 19%, the left ventricular relaxation time constant fell 16% and stiffness of the ventricle fell 19%.

Administration of either batch of PLX cells also resulted in a significant anti-inflammatory effect.

Pluristem chairman and CEO Zami Alberman said, “As we demonstrated last week with the announcement that our cells successfully treated the seven year old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a “first-line of defense” for diastolic dysfunction.”

Pluristem’s share price jumped 5.6% in pre-market trading on Nasdaq to $3.01, giving a market cap of $126.33 million. The share rose 10.6% on the TASE today to NIS 11.50.

Published by Globes [online], Israel business news – www.globes-online.com – on May 15, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem trial finds stem cells improve cardiac dysfunction

What if your very own bone marrow stem cells, upgraded with more immune cells, could be used to increase your chances of survival after a heart attack? Sounds like the stuff of science fiction, but according to a study done by Timothy Henry, MD of the Minneapolis Heart Institute and colleagues, it may in fact be possible. The findings, which were presented at the Society for Cardiovascular Angiography, are considered preliminary until they are published in a peer-reviewed journal, but they are definitely promising.

“With stem cells, we’ve been successful with processes that improve blood flow,” Henry told MedPage Today, and added that there is a significant number of class III heart failure patients who don’t do well on medications or with devices.

“A therapy that would delay heart failure progression would be a major step forward,” he said. “This small trial proved the intervention is safe and all the trends were in the right direction.”

The next phase of the trial will begin in the summer. Stay tuned!

Link:
Stem Cells May Help Heart Patients

CARLSBAD, Calif.–(BUSINESS WIRE)–International Stem Cell Corporation (OTCBB: ISCO) (www.internationalstemcell.com) today announced that several of its leading scientists will present experimental results from three of ISCOs pre-clinical therapeutic programs.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

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International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene …

BRIDGEWATER, N.J.–(BUSINESS WIRE)–

Senesco Technologies, Inc. (Senesco or the Company) (NYSE Amex: SNT), announced today that an oral presentation will be delivered at the 15th Annual Meeting of the American Society of Gene & Cell Therapy. The conference will be held May 16-19th, 2012 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The Company will present during the Cancer-Targeted Gene & Cell Therapy Oral Abstract Session, which will begin Thursday, May 17, at 1:15 P.M. Eastern Time. The oral presentation, entitled SNS01-T, an eIF5A-Based Gene Therapy Nanoparticle Designed for the Treatment of Multiple Myeloma, has Anti-Tumoral Activity in Lymphoma, will describe the effectiveness of SNS01-T in B-cell cancers, which is designed to selectively induce programmed cell death. The talk will be delivered by Catherine Taylor who is from Senesco CSO John Thompsons research laboratory at the University of Waterloo in Ontario, Canada.

About Multiple Myeloma

Multiple myeloma is an incurable cancer of plasma cells, a type of white blood cell derived from B-lymphocytes, normally responsible for the production of antibodies, in which abnormal cells accumulate in the bone marrow leading to bone lesions and interfering with the production of normal blood cells. Senesco was previously granted orphan drug status for SNS01-T, the Companys lead drug candidate for treatment of multiple myeloma.

About Senesco Technologies, Inc.

Senesco, a leader in eIF5A technology, is running a clinical study in multiple myeloma with its lead therapeutic candidate SNS01-T, which targets B-cell cancers by selectively inducing apoptosis by modulating eukaryotic translation initiation factor 5A (eIF5A), which is believed to be an important regulator of cell growth and cell death. Accelerating apoptosis may have applications in treating cancer, while delaying apoptosis may have applications in treating certain inflammatory and ischemic diseases. Senesco has already partnered with leading-edge companies engaged in agricultural biotechnology and is entitled to earn research and development milestones and royalties if its gene-regulating platform technology is incorporated into its partners products. www.senesco.com

Forward-Looking Statements

Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the ability of the Company to consummate additional financings; the Companys ability to recruit and enroll patients for its clinical trial;the development of the Companys gene technology; the approval of the Companys patent applications; the successful implementation of the Companys research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Companys products; the timing and success of the Companys preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance, the Companys ability to comply with the continued listing standards of the NYSE Amex, as well as other factors expressed from time to time in the Companys periodic filings with the Securities and Exchange Commission (the “SEC”). As a result, this press release should be read in conjunction with the Companys periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

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Senesco to Present SNS01-T, an eIF5A-based Nanoparticle in a Phase 1b/2a Trial to Treat Multiple Myeloma, is Effective …

NEW YORK–(BUSINESS WIRE)–

Pfizer Inc announced today that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib. Although PFS was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm. Adverse events in this study were consistent with the known safety profiles for both drugs. Full efficacy and safety data from this study will be presented at an upcoming major medical congress.

Approximately 270,000 people worldwide are diagnosed with renal cell cancer every year with about 20 percent having advanced disease at the time of diagnosis.1 Between 40 and 65 percent of patients in the U.S. who progress following first-line therapy go on to receive a second-line treatment.2,3,4

This trial advances our knowledge about TORISEL in RCC. TORISEL remains an important drug for treatment of advanced kidney cancer based on its pivotal study in first-line patients with poor prognostic risk, said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizers Oncology Business Unit. TORISEL continues to be an important part of Pfizers portfolio of therapies for advanced kidney cancer.

About TORISEL (temsirolimus)

TORISEL is approved in the US and other countries for the treatment of advanced RCC. TORISEL is approved in the European Union for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. In a pivotal Phase 3 study, TORISEL demonstrated median overall survival (OS) in previously untreated patients of 10.9 months in patients with advanced RCC with poor prognostic risk, compared with 7.3 months for interferon-alpha (IFN-).

TORISEL is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced RCC. TORISEL remains the only treatment to show a significant improvement in OS in treatment-nave poor risk patients with advanced RCC.5

Based on preclinical studies, TORISEL inhibits the activity of mTOR, an intracellular protein implicated in multiple growth-related cellular functions including proliferation, growth and survival. The inhibition of mTOR also reduces levels of certain growth factors, such as vascular endothelial growth factor (VEGF), which are overexpressed in solid tumors like kidney cancer and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, nutrients and oxygen needed for growth.

Important TORISEL (temsirolimus) Safety Information

TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1 1.5 x ULN or AST > ULN but bilirubin ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin > 1.5 x ULN.

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Pfizer Provides Topline Results From Phase 3 Study Of Torisel® As Second-Line Treatment In Advanced Renal Cell …

SEBASTIAN Toby, a 6-year-old golden retriever, loves to run and play catch. And Oreo, a 12-year-old border collie mix, also is a bundle of energy.

Movement for both dogs got easier about a month ago when they received a revolutionary stem cell treatment at the Highlands Animal Hospital.

Veterinarian Marcus Kramer performed the successful transplant procedures, which were developed by Kentucky-based MediVet-America.

Both dogs had been in significant pain with a restricted range of motion, as shown on X-rays.

“It’s made a big difference,” said Kramer. “The really amazing thing is that they both healed so quickly. Both dogs had problems with their hips and were suffering from osteoarthritis. Just 30-days later, they are able to walk and run again.”

Adult animal stem cell technology uses the pet’s own regenerative healing power to treat dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries. Under anesthesia, Kramer removed about 40 grams of fat from each dog and separated the stem cells from the fat. He then activated the stem cells under an LED light, and injected them back into the dogs.

Stem cell therapy allows an animal to get off pain and anti-inflammatory drugs, Kramer said. MediVet-America’s therapy is done entirely at the animal hospital in about three hours, and costs about $1,800 for dogs and $2,400 for horses. That compares to thousands of dollars that pet owners could expect to pay for medication over a pet’s lifetime.

Erica Kent, a spokesman for MediVet-America, said using the LED light is integral to the patented-process, because the light helps to awaken stem cells and makes them more active. The three-color light stimulates millions of dormant cells to initiate repair from the moment the cells are injected into the animal’s body, according to the MediVet-America website.

The company is also offering a program that allows pet owners to bank stem cells when animals are younger to use if their pet develops illnesses like arthritis in old age.

STEM CELL THERAPY

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Sebastian veterinarian performs stem cell treatment for pets

SOUTH SAN FRANCISCO, CA–(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company’s 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model — to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective — is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission — “putting humans first” — bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

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VistaGen CEO Issues Update Letter to Stockholders

DENVER, May 14, 2012 /PRNewswire/ — Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences’ clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences’ Regenexx procedures utilize a patient’s own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

“We are proud of our accomplishments in the field of regenerative interventional orthopedics and it’s exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist,” said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. “Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use.”

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor’s degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master’s degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

Contact:

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

DUBLIN–(BUSINESS WIRE)–

Research and Markets (http://www.researchandmarkets.com/research/lffnp7/stem_cell_research) has announced the addition of the “Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)” report to their offering.

Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into any mature cell type. Several broad categories of stem cells exist, including embryonic stem cells, derived from blastocysts; fetal stem cells, obtained from aborted fetuses; adult stem cells, found in adult tissues; cord blood stem cells, isolated from umbilical tissue; dental stem cells, derived from deciduous teeth; cancer stem cells, which give rise to clonal populations of cells that form tumors or disperse in the body; and animal stem cells, derived from non-human sources.

In a developing embryo, stem cells can differentiate into all of the specialized embryonic tissues. In adult organisms, stem and progenitor cells act as a repair system for the body, replenishing specialized cells. Of interest to researchers is the potential for use of stem cells in regenerative medicine to treat conditions ranging from diabetes, to cardiovascular disease and neurological disorders. Additionally, the ability to use stem cells to improve drug target validation and toxicology screening is of intense interest to pharmaceutical companies. Stem cells are also being studied for their ability to improve both the understanding and treatment of birth disorders.

To facilitate research resulting from interest in these far-ranging applications, a large and growing stem cells research products market has emerged. Large companies selling stem cell research products include Life Technologies, BD Biosciences, Thermo Fisher Scientific, and Millipore, although dozens of other suppliers exist as well. Products offered by these companies include: antibodies to stem cell antigens, bead-based stem cell separation systems, stem cell protein purification and analysis tools, tools for DNA and RNA-based characterization of stem cells, stem cell culture and media reagents, stem cell specific growth factors and cytokines, tools for stem cell gene regulation, a range of stem cell services, tools for in vivo and in vitro stem cell tracking, and stem cell lines.

This report explores current market conditions and provides guidance for companies interested in developing strategically positioned stem cell product lines.

Featured elements of this report include:

– What are novel stem cells research products that can be developed?

– What stem cells types are most frequently used by research scientists?

– Which species of stem cells do scientists prefer and what are the factors driving this preference (access, pricing, funding, handling advantages)?

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Research and Markets: Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)

LEUVEN, BELGIUM–(Marketwire -05/15/12)- TiGenix NV (TIG) a leader in the field of cell therapy, today gave a business update and announced the financial results for the first quarter ending March 31, 2012.

Business highlights

Financial highlights

“In the first quarter 2012 we continued to aggressively push our commercial efforts forward,” said Eduardo Bravo, CEO of TiGenix. “As a result sales of ChondroCelect are developing in line with the improved traction we observed in the second part of last year. At the same time we are moving ahead of schedule with most of our clinical adipose stem cell programs. We closed the quarter with almost EUR 17 million cash on hand, which is sufficient to execute on our business plan and reach key inflection points.”

Business update

ChondroCelect sales increase continues apaceThe Company reports net sales growth for the quarter of 123% compared with the same period of last year, and of 62% compared to Q4, 2011, a positive trend reflecting the uptake in Belgium, where we benefit from national reimbursement. In the Netherlands one of the leading private healthcare insurance companies has made treatment with ChondroCelect compulsory for its insured, and no longer reimburses non-ATMP treatments. Similarly, one of the large private insurers in the UK has expressed its intention to routinely reimburse ChondroCelect going forward. Discussions to obtain full national reimbursement keep advancing in the Netherlands, France, Spain and Germany.

Positive outcome of ChondroCelect compassionate use program published in leading journalPositive outcome data from the ChondroCelect compassionate use program (CUP), involving 43 orthopedic centers in 7 European countries, treating 370 patients with ChondroCelect over the span of four years, were published in advance online in Cartilage, the official journal of the International Cartilage Repair Society. The data show that the implantation of ChondroCelect results in a positive benefit/risk ratio when used in an unselected, heterogeneous population, irrespective of the follow-up period, lesion size and type of lesion treated. In addition, the CUP study significantly expands the data set used to obtain approval for ChondroCelect from the European Medicines Agency in 2009, increasing eight-fold, from 43 to 334, the number of patients with long-term follow up data. To date almost 700 patients have been treated with ChondroCelect.

ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule The ADMIRE-CD (Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulizing Crohn’s Disease) Phase III protocol was submitted to Ethics Committees or Health Authorities in all 8 participating countries, and to date approvals have been received in four of those countries already.

Cx611 Phase IIa in RA passes last safety hurdleOn April 17, upon review of the safety data of the first three patients of the third cohort of the company’s Phase IIa clinical trial in rheumatoid arthritis (Cx611), TiGenix received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort. This fact is of major importance. In RA it ensures that the product will not be held back by any dose-limiting factors and that we will be able to move forward with the optimal treatment dose. Of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013.

Last patient treated in Cx621 Phase I clinical trialAll 10 healthy volunteers have been recruited and treated in the Phase I study of Cx621. Cx621 investigates the safety and feasibility of intra-lymphatic administration of stem cells. Intra-lymphatic administration of (all) stem cells is patented by TiGenix. The final report of this trial will be available at the end of June.

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TiGenix Reports Business & Financial Results for the First Quarter 2012

JERUSALEM–(BUSINESS WIRE)–

Gamida Cell announced today that it has closed an internal E financing round of $10 million. All major shareholders participated.

The financing will be used to support the global commercialization of the companys lead cell therapy product, StemEx, in development as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor. The company is currently seeking a strategic partner to join in the global commercialization of StemEx.

The financing will also support the continued development of the companys pipeline of products, primarily the NiCord clinical trial for sickle cell disease and thalassemia.

Mr. Reuven Krupik, chairman of the board of Gamida Cell said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.

The international, multi-center, pivotal registration, Phase III clinical trial of StemEx completed enrollment in February 2012. Clinical outcome is expected in Q4/2012. The market launch of StemEx is planned for 2013. StemEx is likely to be the first allogeneic stem cell product in the market. StemEx is being developed by the Gamida Cell-TEVA joint venture.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, With the continued support of our shareholders and the analysis of the clinical results of the StemEx trial just around the corner, we are now focused on submitting the BLA.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit. Competing products in development use two units. As the average cost of a cord blood unit in the U.S. is $40K, StemEx is expected to be a significantly less expensive treatment option. StemEx is also expected to be available in the market several years before any of the competing products.

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: www.gamida-cell.com.

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Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s …

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