An Update from Dr. Robin Smith, Chairman and CEO

Business Meeting

Greetings from NeoStem where we have recently filed our Company’s 2013 Annual Report on form 10-k, which can be found here, with the SEC and made it available to shareholders, providing a great opportunity to update our investors and the public on NeoStem’s business by looking back at 2013 and ahead to our outlook for 2014.

This year, NeoStem is significantly transforming its therapeutic product pipeline.  We have announced the expansion of our clinical development for both our CD34 Cell Program (focusing on ischemic repair) and our T Regulatory (Treg) Cell Program (focusing on immune modulation). We plan to advance these programs in clinical studies including chronic heart failure, type 1 diabetes and steroid resistant asthma. Of significance, later this year we will also be announcing data results for both our PreSERVE AMI Phase 2 clinical trial, and our collaborator, Dr. Jeffrey Bluestone’s Treg Phase 1 type 1 diabetes trial.

Additionally, PCT, our wholly owned contract manufacturing business, is continuing to advance the regenerative medicine industry by utilizing its newly formed Engineering & Innovation Center to help its clients prepare for successful commercial-scale manufacturing.  The Engineering & Innovation Center develops innovative solutions for PCT’s manufacturing clients by accelerating the use of automation, integration, closed processing and other strategies to address the important issues of scale up, cost of goods, quality control and robustness of the manufacturing process.

Taking a look back at 2013, NeoStem significantly advanced its leadership position in the cell therapy industry, with highlights including:

  • Positive Data Safety Monitoring Board outcomes for the 12 and 18 month data and safety reviews for our PreSERVE AMI Phase 2 clinical trial evaluating AMR-001 for the preservation of heart function after a severe heart attack;
  • Full enrollment of 160 patients in the Phase 2 PreSERVE AMI trial by December 2013;
  • Expansion of CD34 cell intellectual property coverage globally;
  • Establishment of relationship with University of California, San Francisco and Dr. Jeffrey Bluestone resulting in the license of three patent families, Phase 1 data and related IND  to advance the Treg Program in type 1 diabetes;
  • Completion of enrollment in Dr. Bluestone’s Phase 1 trial for type 1 diabetes trial using Treg cells;
  • Expansion of PCT clean rooms  to include a Class 1,000 suite compliant with EU production standards;
  • Continued growth in processing and storage services including additional transplant center client;
  • Receipt of National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) financial support for VSEL™ Technology research;
  • Recruitment of additional seasoned management raising the Company’s profile in the industry and increasing its knowledge, skill base and competitiveness;
  • Listing on NASDAQ Capital Market;
  • During the 2013 calendar year, the market capitalization of the Company increased by 89%; and
  • Raised $62 million from equity financings.

I am pleased to present the following 2014 Outlook and Company milestones for the year ahead:

Therapeutic Product Pipeline   

  • Release of data from PreSERVE AMI Phase 2 trial in 2H 2014;
  • Initiate a Phase 2 chronic heart failure trial in our CD34 Cell Program;
  • Data from the Treg Phase 1 trial in type 1 diabetes presented at the American Diabetes Association Scientific Sessions in June 2014;
  • Advance Treg Program to initiate Phase 2 trial in type 1 diabetes;
  • Initiate proof-of-concept study to determine if Treg cells can be used to treat steroid resistant asthma; and
  • Advance VSELTM research through preclinical studies.

Contract Manufacturing Business

  • Drive further growth in revenues through product and service expansion transaction(s);
  • Advance initiatives in Engineering & Innovation Center to lower cost of goods and improve robustness and efficiency of the manufacturing process in anticipation of commercial production; and
  • Expand manufacturing capabilities internationally.

Strategic Transactions

  • Explore strategic acquisitions and business development transactions to increase shareholder value.

Thank you for your confidence in our company and for your continued support.  I, as well as other executive team members from NeoStem, look forward to updating you further as more exciting and significant developments occur.

Warm regards,

Robin L. Smith

Chairman and CEO

NeoStem, Inc.


Forward Looking Statements

This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this blog, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company's other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.

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