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NeoStem CEO's Letter To Shareholders

Stocks in this article: NBS

VSELā„¢ Technology Platform -

NeoStem's pipeline extends beyond cardiovascular diseases. The use of human VSELs TM for regenerative medicine presents the possibility of capturing the key advantages associated with embryonic stem cells without the ethical or moral dilemmas associated with their use, or the potential negative biological effects associated with embryonic stem cells, such as their propensity to form tumors. VSELs TM offer the advantage of using autologous stem cells (i.e., the patient's own cells) for therapy, as opposed to having to rely on donor cells that are susceptible to immune rejection. Our research has identified cells in human blood and bone marrow that have many of the key properties described for murine VSELs TM. This research includes evidence of primitivism, pluripotency and tri-lineage differentiation. These observations provide the groundwork for the development of VSEL TM therapies to regenerate or repair damaged or diseased tissues in human subjects. Initial experiments suggest that, in certain contexts, VSELs may have a regenerative "potency" that is orders of magnitude greater than mesenchymal stem cells.

We seek to pursue and commercialize therapeutic VSEL TM products in selected clinical applications and markets based on unmet medical needs. Largely through grant funding, we are exploring VSEL TM stem cell treatments for periodontitis, healing complex skin and soft tissue wounds, corneal regeneration and repair, age-related macular degeneration, nerve regeneration and acute radiation. We anticipate that a single clinical manufacturing process will be developed for these indications, collectively, and that the major pacing item will be the generation of preclinical data to support an IND application for a Phase 1 clinical trial. We expect to file an IND to commence human clinical studies treating periodontitis in late 2013 or early 2014.

Athelos -

Through our Athelos subsidiary (which is 20% owned by Becton-Dickinson), we are developing therapeutic products using a person's immune cells to treat disorders of the immune system. Many immune-mediated diseases are a result of an imbalance in the immune system whereby inflammatory cells go unchecked. Therapy using regulatory T cells (Treg) represents a novel approach to restoring immune balance by enhancing Treg cell number and function to inhibit pathogenic immune responses. Through exclusive world-wide licenses, Athelos has secured the rights to a broad patent estate within the Treg field, covering natural Tregs (nTregs), induced Tregs (iTregs) and methods of treating or preventing certain conditions and/or diseases. Both types of Tregs have been shown in pre-clinical studies to be important in modulating autoimmune and inflammatory diseases. Natural Tregs have been evaluated by others in early phase human clinical trials and shown to be safe with suggestions of clinical benefit in graft-versus-host disease. Both nTregs and iTregs have demonstrated the ability to treat conditions like diabetes, inflammatory bowel disease and organ transplant tolerance in animal models of disease.

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