StemCells, Inc. Reports Fourth Quarter and Year End 2011 Financial Results and Provides Business Update

NEWARK, Calif., March 13, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the fourth quarter and year ended December 31, 2011 and provided a business update.

"The StemCells team made significant progress in 2011 with regard to two critical goals for the Company, namely accelerating and broadening our HuCNS-SC neural stem cell clinical trial agenda for diseases of, and injuries to, the central nervous system, while at the same time reducing our operating cash burn. We are now uniquely positioned as the only stem cell company pursuing clinical trials for disorders of all three organs of the CNS, the brain, spinal cord and eye," said Martin McGlynn, President and CEO of StemCells, Inc. "We have strong preclinical data underlying all our clinical trials, much of which has already been published in peer-reviewed journals, but we realize that the true test of our proprietary cell-based technology will be in the clinic. In this regard, I am pleased to confirm StemCells remains on track to report safety and efficacy data from our recently completed Phase I Pelizeaus-Merzbacher disease trial at the European Leukodystrophy Association meeting to be held in Paris, March 31-April 1. We are confident that executing our clinical trial agenda, while controlling our cash burn, is the best way to build lasting shareholder value."

Fourth Quarter and Recent Business Highlights

Therapeutic Product Development

Tools and Technologies Programs

Other Business Activities

Fourth Quarter 2011 Financial Results

For the fourth quarter of 2011, the Company reported a net loss of $7,212,000, or $(0.47) per share, compared with a net loss of $8,957,000, or $(0.70) per share, for the fourth quarter of 2010. Loss from operations in the fourth quarter of 2011 was $7,313,000, which was 5% lower when compared to the $7,706,000 loss from operations in the fourth quarter of 2010. Included in net loss and loss from operations in the fourth quarter of 2011 is a charge of $655,000 for the write-off of an acquired intangible asset.

Total revenue during the fourth quarter of 2011 was $541,000, compared to $699,000 in the same period of 2010. The decrease of 23% from 2010 to 2011 was due to both lower product sales and lower licensing and grant revenues. Total revenues in the fourth quarter of 2010 were higher due to a particularly strong quarter in our SC Proven business as well as the receipt of a milestone payment under a licensing agreement of approximately $438,000 in 2010.

Total operating expenses in the fourth quarter of 2011 were $7,807,000, compared to $8,341,000 in the fourth quarter of 2010. Excluding the impairment of the intangible asset, which is included as an operating expense, total operating expenses in the fourth quarter of 2011 were $7,152,000, or 14% lower than the same period in 2010. In the fourth quarter of 2011, research and development expenses totaled $4,834,000, or 18% less than in the same period of 2010, while selling, general and administrative expenses totaled $2,290,000, or 8% lower. The significant reduction in operating expenses was primarily attributable to the Company's cost containment efforts, including the reduction in force effected in May 2011.

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StemCells, Inc. Reports Fourth Quarter and Year End 2011 Financial Results and Provides Business Update

Newburgh Man Dies While Receiving Stem Cell Treatment in Florida

A homicide investigation in Florida has some far reaching ties to the Tri-State. A Newburgh man was there for stem cell treatment and died during the procedure. Richard Poling, 77, went to Florida for treatment of a lung disease he's battled for more than ten years, but he didn't make it through the procedure. Now the doctor he chose, Dr. Zannos Grekos, is at the heart of a homicide investigation. But his isn't the first story about Dr. Grekos that ends poorly. Barb Neuman's husband was diagnosed with a different lung disease, but went to the same doctor, in 2009. They mortgaged their home to afford more than $50,000 for the treatment. Unfortunately Neuman's husband died nine months later. But other patients speak highly of Dr. Grekos. Grekos' license had been restricted in 2011 for performing undisclosed stem cell research on a woman with breast cancer who later died. Neuman says she hopes her story can teach others a valuable lesson. No one has been arrested in the three deaths. The Florida State Surgeon General has issued an emergency suspension on Grekos' license, and Lee County Sheriff's Deputies are investigating the deaths.

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Newburgh Man Dies While Receiving Stem Cell Treatment in Florida

Patient dies during procedure

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

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Patient dies during procedure

Doctor accused of illegal stem cell therapy suspended

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

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Doctor accused of illegal stem cell therapy suspended

Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

Stem cell treatment tricks immune system into accepting donor organs, study shows

By Julie Steenhuysen

CHICAGO Scientists have found a way to trick the immune system into accepting organs from a mismatched, unrelated organ donor, a finding that could help patients avoid a lifetime of drugs to prevent rejection of the donated organ.

Of eight kidney transplant patients who have been treated with this new approach, five have managed to avoid taking anti-rejection drugs a year after their surgery, according to the study published on Wednesday in Science Translational Medicine.

And one patient, 47-year-old Lindsay Porter of Chicago, is completely free of anti-rejection drugs nearly two years after her kidney transplant.

This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients

I hear about the challenges recipients have to face with their medications and it is significant. Its almost surreal when I think about it because I feel so healthy and normal, she said in a statement.

With conventional organ transplants, recipients need to take pills to suppress their immune systems for the rest of their lives. These drugs can cause serious side effects, including high blood pressure, diabetes, infection, heart disease and cancer.

This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients, Dr. Suzanne Ildstad, director of the Institute of Cellular Therapeutics at the University of Louisville in Kentucky, who developed the new approach, said in a statement.

But some experts say the procedure, in which patients undergo a bone marrow transplant from an unmatched organ donor, is too risky, especially given the relative safety of kidney transplants.

We have to think about the risks and benefits. Since the current treatment is so stable, it really has to be safe, said Dr. Tatsuo Kawai, a transplant surgeon at Harvard Medical School, who wrote a commentary on the new approach in the journal.

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Stem cell treatment tricks immune system into accepting donor organs, study shows

Doctor's license suspended after patient's death

BONITA SPRINGS, FL -

The state Surgeon General has issued an emergency suspension of the license of Dr. Zannos Grekos for providing a stem cell treatment to a patient contrary to previous restrictions placed on his license. The patient died during the treatment.

According to the emergency suspension order, in February 2011 Dr. Grekos was ordered not to perform any stem cell treatments on patients.

On March 2, 2012, Grekos is accused of treating an elderly man with pulmonary hypertension and pulmonary fibrosis with stem cells.

The suspension order says Grekos harvested tissue from the patient's abdomen that commonly contains stem cells. That tissue was sent to a lab to have the stem cells concentrated.

Those concentrated stem cells were then injected into the patient's bloodstream, according to the order.

The patient died of cardiac arrest during the treatment.

Because the stem cell treatment violated previous restrictions on Grekos' license, the state requested the emergency suspension of his license.

One section of the emergency suspension order states, "Nothing short of the immediate suspension of Dr. Grekos' license to practice medicine would be sufficient to protect the public from the danger of harm presented by Dr. Grekos."

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Doctor's license suspended after patient's death

Florida suspends doctor accused of illegal stem cell therapy

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 1:34 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy treatment on an elderly patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Dr. Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and allegedly causing the death of an unnamed elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment earlier this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos's activities in 2009 and, at that time, he said he was using stem cell therapy for a company he called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he claimed would help heal crippling diseases, mostly associated with lung problems.

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Florida suspends doctor accused of illegal stem cell therapy

Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Wayzata HS student takes stem cell research to national competition

by Tom Crann, Minnesota Public Radio

March 7, 2012

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St. Paul, Minn. A Minnesota teen will be one of 40 high school students nationwide competing for a top prize of $100,000 at the annual Intel Science Talent Search in Washington D.C. Thursday.

Evan Chen, a student at Wayzata High School, focused his research on a type of stem cell that could help replace and regenerate muscle lost by people suffering from muscular dystrophy.

Chen told Tom Crann of All Things Considered that he was inspired to do the research after meeting three boys from Taiwan who were in Minnesota seeking treatment for the disease.

"They left after the experiment; the treatment didn't work," Chen said. "I was pushed not only by my experience with them, but also my fascination with stem cells."

The advanced research Chen envisioned couldn't be done in a high school laboratory, so Chen approached local scientists for help.

"Eventually one sat down with me and we talked about the research I wanted to do," Chen said. "He was like, 'Sure, you can use my lab for this.'"

Chen and the other students will be judged by a panel of scientists. Other projects in the contest include an inexpensive system to detect landmines and a light-activated cancer treatment drug.

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Wayzata HS student takes stem cell research to national competition