NeoStem CEO's Letter to Shareholders

Posted: Published on March 21st, 2013

This post was added by Dr. Richardson

NEW YORK, March 19, 2013 (GLOBE NEWSWIRE) --

Dear NeoStem Shareholders,

Regenerative medicine is the catalyst to radically change the practice of medicine from that of chronic treatment to that of cure. The shift is away from treating the symptoms with synthetic drugs towards treating the underlying cause of disease by using one's own natural cells. Cell therapy holds the promise of prolonging and, most importantly, enhancing quality of life. This is the future of medicine and it is our singular mission to lead the way.

NeoStem (NYSE MKT:NBS) is an integrative force in the cell therapy industry. By vertically integrating the collection, storage and processing of cellular material with the development, manufacture, distribution, and delivery of cell therapy products, we are positioned to capitalize on the emerging cell therapy industry. We provide such contract development and manufacturing services for clients and we also have a proprietary pipeline of cell therapy products in development designed to address unmet medical needs, including cardiovascular disease (MI and CHF), immune disorders (type 1 diabetes, steroid resistant asthma, organ rejection) and tissue repair (wounds, osteoporosis, macular degeneration, etc). Our most advanced cardiovascular asset, AMR-001, is very exciting (see video at http://www.neostem.com/videos.html) and is built upon a very strong intellectual property portfolio.

PreSERVE Phase 2 Clinical Trial --

Presently, with thirty two (32) clinical trial sites having enrolled over ninety (90) patients, Amorcyte has enrolled over half of the scheduled patients in its PreSERVE-AMI Phase 2 clinical trial. We are also pleased to report that an additional twenty (20) clinical trial sites are in the process of coming on board. In the PreSERVE trial, stem cells are collected from the patient's bone marrow and enriched, not expanded, to increase potency. These cells are stabilized and have a 72-hour shelf life. The cells are infused via the infarct-related artery 5 to 11 days following a stent placement -- the optimal time frame to prevent adverse ventricular remodeling. There, they are being tested to save damaged tissue that would otherwise die within days or weeks, consequently preserving cardiac function and potentially preventing clinical adverse events by releasing chemicals and proteins that grow blood vessels through a process called angiogenesis. We received six and twelve month evaluations of our trial by the Data Safety Monitoring Board confirming that there are no safety signals that would preclude the trial from continuing as planned and expect to complete enrollment in 2013 with data read out 6-8 months after the last patient is enrolled.

An initial assessment of enrollment data from the PreSERVE Phase 2 clinical trial found that one third of patients screened for enrollment who had suffered an ST segment elevation acute myocardial infarction (STEMI) have a persistent low ejection fraction 3-4 days post infarction. Based on this initial assessment of enrollment data and assuming that AMR-001 is ultimately approved by the FDA for use in the population NeoStem is studying and there are not further restrictions implemented in Phase 3 studies, the Company believes that there is a large eligible U.S. market for AMR-001 in the treatment of heart attack patients.

We also believe that the AMR-001 platform may be applicable to other conditions resulting from underlying ischemia and expect to file an IND in 2013 for the use of AMR-001 to arrest the progression of congestive heart failure.

Amorcyte Intellectual Property Portfolio --

AMR-001 now has the benefit of 3 (soon to be 4) U.S patents, 2 patents (soon to be 3) outside of the U.S. and 31 additional patents pending around the world. In brief, our granted U.S. patents are as follows:

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NeoStem CEO's Letter to Shareholders

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