Stem cell therapy developer Athersys (NSDQ:ATHX) and partner Pfizer (NYSE:PFE) have begun enrolling patients in a Phase II clinical trial for inflammatory bowel disease.
The trial marks an “important milestone” for Athersys because it’s the first time the company’s MultiStem treatment has advanced to a Phase II trial, CEO Gil Van Bokkelen said in a conference call with analysts to discuss the company’s quarterly financial numbers.
MultiStem is an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources. The cells have a drug-like effect that reduces inflammation, protects damaged tissue and forms new blood vessels. Athersys is pursuing several clinical applications for MultiStem, including heart attack, stroke, blood cancer and spinal injury.
Pfizer is bearing all the costs of the 126-patient inflammatory bowel disease study, Van Bokkelen said.
In addition to the clinical progress, another key benefit of working with Pfizer on the study is the opportunity for Athersys to forge future partnerships with the deep-pocketed pharmaceuticals giant, which posted $68 billion in revenue last year.
“That is certainly a possibility,” Van Bokkelen said when pressed by an analyst on future Pfizer collaborations. “I think Pfizer is excited by the work we’re doing together. I think the relationship is going extremely well.”
Athersys also announced plans to begin a Phase II trial of MultiStem for the treatment of acute myocardial infarction (heart attack) later this summer. The company is finalizing the study’s design and selecting a contract research organization to work with, Van Bokkelen said. Athersys is collaborating with Angiotech Pharmaceuticals on the heart attack application of MultiStem.
For a company with no products on the market like Athersys, clinical developments such as the Phase II trials always take precedence over earnings numbers. Nonetheless, the numbers did hold some positives for Athersys, primarily in the form of increased revenue thanks to the Pfizer collaboration and a similar deal with RTI Biologics to develop orthopedic implants.
Fourth-quarter revenue more than tripled to $3.3 million, while the company’s net loss for the quarter was $2.1 million, down from a $5 million loss in the year-ago quarter. More than $700,000 in federal grants from last year’s health reform legislation also provided a boost to revenue in the quarter.
For the full year, revenue quadrupled to $8.9 million, driven by the Pfizer and RTI deals. Athersys posted a net loss of $11.4 million compared with a loss of $15.4 million the prior year.
On. Dec 31, the company’s cash on hand stood at $15 million, though the number doesn’t take into account the proceeds of a $13 million stock sale in January. COO B.J. Lehmann declined to provide guidance on how long the cash would last Athersys when asked by an analyst.
