In August 2013, Dr. Douglas Losordo joined NeoStem as Chief Medical Officer to assist the Company in its pursuit of promising cell therapies, including a product candidate using CD34+ cells to repair ischemic tissue, and take NeoStem a step closer to true disease modification or reversal, instead of relegating patients to symptom palliation. Dr. Losordo is well regarded for his career-long efforts to develop novel therapeutics for patients with advanced cardiovascular diseases. As a scientist he obtained over $35 million in National Institutes of Health funding, discovering and developing new therapeutic concepts in the laboratory, providing the basis for clinical studies. He has led first in human studies in multiple gene and adult stem cell therapies in patients with cardiovascular diseases, including therapies now in phase 3 testing. He is a highly sought speaker, having given over 200 international lectures. In 2007, in recognition of his pioneering laboratory work, he gave the Thomas W. Smith Memorial lecture at the American Heart Association's annual scientific session. He is an associate editor of Circulation Research, the basic science journal of the American Heart Association, and serves on the editorial boards of a number of scientific journals. Dr. Losordo received his medical degree from the University of Vermont.
- Progenitor Cell Therapy ("PCT") -- In Q2 2013, PCT generated $4.4 million, a 73% increase in revenues from Q1 2013. PCT completed three process development contracts in Q2 2013, triggering higher revenue recognition. PCT also recently signed two new clients, including a large pharmaceutical company that is entering the cell therapy sector, and continues to build its business. PCT has provided services to over 100 clients in its more than 15-year history, and is the only contract manufacturing organization to have worked with a client's product through all of the phases of its clinical trials and ultimately to FDA approval. PCT offers its clients and NeoStem cell processing and development capabilities on both the East and West Coasts of the U.S. and is pursuing plans to expand internationally.
- Amorcyte – The Company continued enrollment in its PreSERVE Phase 2 clinical trial with 120 patients infused as of August 8, 2013 and is on track to complete patient enrollment for this trial in 2013 with data read out 6-8 months after the last patient is infused.
- Athelos – The Company continues to progress with its T-cell program with the goal of developing treatments for immune-mediated diseases, such as autoimmune disorders such as type 1 diabetes ("T1D") and inflammatory conditions such as steroid resistant asthma. On July 15 th, the Company announced that it has executed agreements with the University of California, San Francisco and the laboratories of Jeffrey Bluestone, PhD, and Qizhi Tang, PhD, to collaborate on the development of human Regulatory T cells ("Treg") for the treatment of T1D. This collaboration advances NeoStem's role in the development and commercialization of immunomodulatory cellular therapeutic products for the treatment of intractable diseases involving the immune system. This collaboration also advances NeoStem's Treg program towards a clinical Phase 2 trial to evaluate the efficacy of autologous Tregs in T1D. Under the agreements, NeoStem will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned Phase 2 trial to treat patients newly diagnosed with T1D and will also collaborate with Dr. Bluestone on allo-specific Tregs for organ transplant tolerance in another Phase 2 study. Additionally, NeoStem plans to sponsor a Phase 1b/2a study on the use of Tregs for the treatment of steroid resistant asthma. The collaboration includes the research effort to develop the next generation of Treg products for therapeutic use.
Use of Non-GAAP Financial Measures
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