NeoStem (NASDAQ: NBS) recently announced the completion of the enrollment phase for its Phase II trial. This 160 patient trial will determine the safety and effect for the company's most advanced therapy - AMR-001 - on patients with acute myocardial infarction. The recent announcement did not have a noticeable impact on the stock's performance, although it does signify that the company is on track to have the all-important top-line data release for AMR-001 in 2014.
Four 2014 Catalysts to wait for
There are a number of catalysts to look forward to in 2014. Here are four of the most important ones, and our estimates on when they should occur:
* June 2014 - Primary completion of Phase II AMI-001 trial in STEMI
* 3Q 2014 - Phase II data from Phase II AMI-001 trial in STEMI
* 1H 2014 - Phase I results for regulatory T-cell program in diabetes
* 2H 2014 - Initiation of Phase II for regulator T-cell program in diabetes
Of these events, investors may want to pay the most attention to the AMI-001 Phase II data since we believe this would probably have the most significant impact on share price. The indication being targeted is huge (>220,000 patients per year), and we believe that Neostem would see much more interest after their top cell therapy is validated with Phase II data.
AMR-001 is an autologous cell therapy made up of CD34+ and CXCR4+ cells. It has demonstrated the ability to improve patient perfusion rates in previous clinical trials. After Phase II data is released, we are expecting to see comparable benefit in a much larger patient population. This therapy Is being developed for the treatment of acute myocardial infarction (via the Phase II PreSERVE trial mentioned earlier). It will also be a possible treatment for congestive heart failure (Phase IB/IIA pending) and traumatic brain injury (preclinical).
NeoStem continues to generate substantial (~$3.7 M/quarter) revenue from its Progenitor Cell Therapy (PCT) division, and many investors see this as a way to support the company's clinical development programs in cardiovascular disease, autoimmune disorders and tissue regeneration.