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NeoStem Announces Third Quarter 2013 Financial Results And Provides Corporate Update

NEW YORK, Nov. 7, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced its third quarter results and provided highlights of its recent activities.

Robin L. Smith, MD, MBA, Chairman and Chief Executive Officer of NeoStem, commented on the results, "The quarter was marked by excellent progress across several operational and clinical areas.  Our pipeline of proprietary cell therapy products continues to develop and we are on track to complete enrollment of our PreSERVE Phase 2 clinical trial with AMR-001 this year. We have expanded our senior management team with several key hires, strengthened our intellectual property portfolio and signed academic collaborations with the University of California, San Francisco (UCSF) and leading researchers relating to our human Regulatory T cells (Treg) platform." 

Dr. Smith added, "With the recent, highly successful public equity offering, NeoStem now has cash reserves in excess of $50 million to enable us to advance multiple pipeline projects, grow the contract development and manufacturing business of our wholly-owned subsidiary PCT and position the Company for strategic and business development partnerships.  In addition, PCT has reported 50% more Clinical Service active clients, compared to the same period last year.  Through Clinical Services, PCT offers its clients and NeoStem process development and clinical manufacturing capabilities on both the East and West Coasts of the U.S., and we expect to complete the expansion of both facilities by the first quarter of 2014."

Third Quarter Financial Highlights

  • Revenues from continuing operations for the three and nine months ended September 30, 2013 were $3.7 million and $10.6 million, respectively, compared to $4.4 million and $11.6 million for the same periods in 2012.  
  • For both the three and nine months ended September 30, 2013, revenues for Process Development decreased, principally as a result of our accounting policy for revenue recognition of those client services. Those revenues are only recognized at the time that a particular contract is completed. Process Development revenue is expected to continue to fluctuate from period to period because of this policy.
  • For the three and nine months ended September 30, 2013, net losses from continuing operations were $9.3 million and $26.8 million, respectively, compared to $8.5 million and $23.8 million for the same periods in 2012.  
  • For the nine months ended September 30, 2013, net loss from continuing operations excluding non-cash charges was $19.9 million (see reconciliation in the Appendix below).
  • NeoStem ended the third quarter with $16.9 million in cash. Subsequent to September 30, 2013, NeoStem completed a public equity offering and received gross proceeds of approximately $40.3 million, before offering expenses, and raised an additional $1.0 million in cash through warrant and option exercises.

Corporate Highlights for the Third Quarter and Recent Weeks

  • Continued enrollment in the PreSERVE Phase 2 clinical trial investigating NeoStem's most advanced product candidate, AMR-001, in preserving heart muscle function after a severe heart attack.  The data Safety Monitoring Board (DSMB) recommended continuing this trial following a third interim data and safety review.  Enrollment is on track for completion in 2013 and data read out is expected 6-8 months after the last patient is infused.
  • Executed agreements with UCSF 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 type 1 diabetes.
  • Continued the expansion of intellectual property including licensing 3 families of patents from UCSF related to the Company's Treg platform.
  • Appointed Stephen W. Potter as Executive Vice President.
  • Appointed Douglas W. Losordo, MD, FACC, FAHA, as Chief Medical Officer.  Dr. Losordo is a leader in cell therapy research and a renowned cardiologist.  
  • Appointed Robert Dickey IV as Chief Financial Officer. 
  • NeoStem subsidiary PCT entered into a collaboration with ATMI, Inc., a global technology company and leader in single-use bioprocess solutions. The two companies will collaborate on a non-exclusive basis enabling PCT and PCT's affiliates to offer to their respective clients access to the Integrity ® Xpansion™ technology platform from ATMI in order to develop cell therapies in a more cost effective and robust way.
  • Transferred listing of shares to NASDAQ from NYSE MKT
  • Effected a 1-for-10 reverse split of the Company's common stock.

Appendix

Use of Non-GAAP Financial Measures

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