UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2012
NEOSTEM, INC.
(Exact Name of Registrant as Specified in Charter)
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Delaware
(State or Other Jurisdiction
of Incorporation)
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001-33650
(Commission
File Number)
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22-2343568
(IRS Employer
Identification No.)
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420 Lexington Avenue, Suite 450, New York, New York 10170
(Address of Principal Executive Offices)(Zip Code)
(212) 584-4180
Registrant's Telephone Number
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events
On January 10, 2012, Amorcyte, LLC, a wholly-owned subsidiary of NeoStem, Inc., a Delaware corporation (the “Company” or “NeoStem”), issued a press release relating to the expansion of its intellectual property protection around its lead product candidate, AMR-001. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.
Forward Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1 hereto, contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions, although some forward-looking statements are expressed differently. Forward-looking statements represent the Company’s management judgment regarding future events. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. All statements other than the statements of historical fact included in this Current Report on Form 8-K are forward-looking statements. The Company cannot guarantee the accuracy of the forward-looking statements, and you should be aware that the Company’s actual results could differ materially from those contained in the forward-looking statements due to a number of factors, including the statements under “Risk Factors” contained in the Company’s reports filed with the Securities and Exchange Commission (the “SEC”).
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit No.
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Description
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99.1
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Press Release dated January 10, 2012
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NEOSTEM, INC.
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By:
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/s/ Catherine M. Vaczy
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Name:
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Catherine M. Vaczy, Esq.
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Title:
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Vice President and General Counsel
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Dated: January 11, 2012
Exhibit 99.1
Amorcyte, a NeoStem Company, Announces Expansion of
Intellectual Property Coverage
NEW YORK , Jan. 10, 2012 /PRNewswire/ -- Amorcyte, Inc. ("Amorcyte"), a NeoStem, Inc. company (NYSE Amex: NBS) ("NeoStem" or the "Company"), today announced the expansion of intellectual property protection around its lead product candidate, AMR-001, with the grant of U.S. patent number 8,088,370 by the United States Patent and Trademark Office. Amorcyte's first issued patent (7,794,705) entitled "Compositions and Methods of Vascular Injury Repair," protects a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction (AMI). Newly granted patent 8,088,370 covers the use of AMR-001 in the repair of any vascular injury caused by vascular insufficiency, and effectively expands the breadth of the patented claims beyond the current target indications for AMR-001.
"By carefully defining the mechanism of action of AMR-001 -- the homing and integration of CD34+CXCR4+ cells to repair and re-vascularize ischemic tissue -- we have positioned Amorcyte to achieve broader indications beyond cardiovascular injury," said Dr. Andrew L. Pecora , Chief Medical Officer of NeoStem and founder of Amorcyte.
"This successful expansion of NeoStem's intellectual property through Amorcyte is another validation of the value and opportunity created through the 2011 acquisition of Amorcyte, which promises to be transformative for NeoStem," said Dr. Robin L. Smith , Chairman and CEO of NeoStem. "With patents for both composition of matter and methods of use, together with this recent expansion, we believe the protection around the IP for Amorcyte's therapy is strong and broad. We look forward to the start of enrollment of patients in the Phase 2 trial for AMR-001 for treatment of AMI as we seek to meet our 2012 goal of completing enrollment of approximately 160 patients."
For more information on the clinical trial please visit www.amorcyte.com or view the NeoStem corporate presentation at www.neostem.com/investor-relations/. To read the complete patent, please visit the USPTO website.
About NeoStem, Inc. and Amorcyte, Inc., a NeoStem company
NeoStem, Inc. ("NeoStem") is a leader in the development and manufacture of cell therapies. NeoStem has a strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT's core expertise in manufacturing and NeoStem's extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, Inc., also a NeoStem company, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and is poised to commence enrollment in a Phase 2 trial for the preservation of heart function after a heart attack. Amorcyte expects to begin a Phase 1 clinical trial in 2012 for AMR-001 for the treatment of patients with congestive heart failure. Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with our partner Becton-Dickinson. NeoStem's pre-clinical assets include its VSEL™ Technology platform for regenerative medicine, which NeoStem believes to be an endogenous, pluripotent, non-embryonic stem cell that has the potential to change the paradigm of cell therapy as we know it today.
For more information on NeoStem and Amorcyte, please visit www.neostem.com and www.amorcyte.com
Forward-Looking Statements
This press release 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 press release, and involve certain risks and uncertainties. Forward looking statements include statements herein with respect to the successful execution of the Company's business and medical strategy, including with respect to the development of AMR-001 and other cell therapies, about which no assurance can be given. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's definitive proxy statement filed with the Securities and Exchange Commission on September 16, 2011 and in the Company's periodic filings with the Securities and Exchange Commission. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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For more information, please contact:
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Trout Group
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NeoStem, Inc.
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Gitanjali Jain Ogawa, Vice President
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Robin Smith, CEO
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Phone: +1-646-378-2949
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Phone: +1-212-584-4174
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Email: gogawa@troutgroup.com
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Email: rsmith@neostem.com
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