Cleveland-based Athersys (NYSE:ATHX) has a full plate as it continues to advance its “off the shelf” stem cell therapy, MultiStem, through clinical trials in several indications. That means shareholders can expect more R&D spending and potential new partnerships this year as the company continues developing MultiStem and its 5HT2C agonist program.
Athersys CEO Gil Van Bokkelen and B.J. Lehmann, its chief operating officer, reported in a financial results conference call a few things shareholders might expect in 2013:
- Top-line data from the phase 2 study of MultiStem in 130 patients with ulcerative colitis being conducted by Pfizer. Originally, enrollment in this study was set to be completed by late last year, but Van Bokkelen said it’s now expected to wrap up within the next several months and will put the company in a position to have top-line results in the second half of the year.
- More R&D spending than in 2012, as a reflection of more clinical activity, Lehmann said.
- Feedback from the U.S Food and Drug Administration on Athersys’ proposed clinical plan for a phase 2/3 study of MultiStem for treating graft-versus-host disease in patients with leukemia and other blood cancers who have undergone chemotherapy. “I think we’re going to hear back from them relatively soon,” Van Bokkelen said, although he added that it will likely be more than the usual 45 days for the FDA to return thoughts and questions because of the atypical design of the trial.
- No data just yet from a phase 2 study of the company’s lead program using MultiStem in patients with stroke. Athersys has touted its stroke program as one that may be able to extend the time window for administering treatments after stroke from a few hours with thrombolytics to one to two days with MultiStem. During the third quarter of last year, Athersys began enrolling the third and final cohort of patients into its phase 2 study and intends to complete that enrollment in the first quarter of next year, with initial results delivered in the second half of 2014.
- A collaborative study with a transplant group at University of Regensburg in Germany exploring the use of MultiStem in patients after liver transplant. “We will provide limited financial support for this investigator-sponsored phase 1 study and provide clinical-grade products to conduct a trial.”
- A potential partnership. “We remain in active discussions and diligence activities with multiple companies regarding potential partnerships and collaborations including for our 5HT2C agonist program for the treatment of obesity, schizophrenia, or both, and for the development of MultiStem for multiple indications,” Van Bokkelen said. “We intend to enter into one or more business programs to advance these programs.” Athersys has been conducting pilot studies with prospective partners in specific areas that are of mutual interest, he added.
- Continued preclinical development of MultiStem in traumatic brain injury, spinal cord injury, multiple sclerosis, peripheral vascular disease and congestive heart failure.
Athersys reported lower revenue of $8.7 million in 2012, down from $10.3 million in 2011. The company ended the year with $25.5 million in cash and cash equivalents.