NEW YORK, March 13, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company") today announced 2013 year end results and provided an update on its business.
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation.
"NeoStem is positioned for significant transformation in our product pipeline in 2014," commented Dr. Robin Smith, NeoStem's Chairman and CEO. "In addition to announcing clinical results for product candidates in both our CD34 Cell Program for ischemic repair and T Regulatory (Treg) Cell Program for immune modulation, we plan to advance these programs in studies that include type 1 diabetes, chronic heart failure and steroid resistant asthma. Additionally, our wholly owned contract manufacturing business, PCT, will continue to prepare for successful commercial-scale manufacturing through its newly formed Engineering & Innovation Center designed to support the manufacturing of high quality products with a reasonable cost of goods."2013 Business Highlights In 2013, NeoStem significantly advanced its leadership 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 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%;
- Raised $62 million from equity financings.
- Revenues for the year were $14.7 million compared to $14.3 million in 2012. PCT's clinical services revenues, representing the largest component of revenues, increased 14%. These revenues were impacted by the deferral of revenue on certain process development contracts, in accordance with our revenue recognition policy. The revenue increase was also partially offset by lower clinical service reimbursable revenue due changes in certain customer contractual terms. Overall, there were approximately 50% more active clients compared to 2012.
- Year-end cash balance was $46.1 million.
- Operating expenses were $38.5 million compared to $32.8 million in 2012. Research and development expenses increased $6.5 million in support of our Phase 2 PreSERVE AMI trial and the advancement of our Treg Program. Selling, general and administrative expenses decreased $0.7 million.
- Net loss from continuing operations was $39.5 million compared to $36.1 million in 2012.
- Net loss excluding non-cash charges was $28.7 million (see reconciliation in the Appendix below).