Unassociated Document
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 4, 2012

NEOSTEM, INC.
(Exact Name of Registrant as Specified in Charter)


Delaware
(State or Other Jurisdiction
of Incorporation)
001-33650
(Commission
File Number)
22-2343568
(IRS Employer
Identification No.)


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):

o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 

 

Item 5.02.  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 (e)  Compensatory Arrangements
 
On January 4, 2012 the Compensation Committee of NeoStem, Inc. (“NeoStem” or the “Company”), after consultation with the Board, adopted the NeoStem 2012 Board of Directors Compensation Plan (the “Board of Directors Compensation Plan”), which provides that each Board member who is not an employee of NeoStem or one of its wholly-owned subsidiaries shall be authorized to receive, in such Board member’s sole discretion, either (i) options to purchase 120,000 shares of the Company’s common stock (“Common Stock”); or (ii) a stock award of 120,000 shares of our Common Stock, in either case issued under and subject to the terms of the 2009 Equity Compensation Plan (the “2009 Plan”), for his or her service as a Board member. These options and shares shall vest fully on the date of grant. The Board of Directors Compensation Plan further provides that the Chair of each Board Committee who is not an employee of the Company or any of its wholly-owned subsidiaries shall be authorized to additionally receive, in such Committee Chair’s sole discretion, either (i) options to purchase 50,000 shares of our Common Stock; or (ii) a stock award of 50,000 shares of our Common Stock, in either case issued under and subject to the terms of the 2009 Plan, for his or her service as a Committee Chair.   These options and shares shall vest fully on the date of grant.  In each case, the exercise price of options authorized pursuant to the Board of Directors Compensation Plan shall be equal to the closing price of a share of our Common Stock on the date of grant. The foregoing shall be issued on January 4th of each year during the term of the Board of Directors Compensation Plan, commencing January 4, 2012.  Directors who are not employees of NeoStem or its wholly-owned subsidiaries are also entitled to cash fees equal to $7,500 per calendar quarter commencing with the quarterly period ending March 31, 2012.  Notwithstanding the foregoing, the Compensation Committee shall have the discretion to renew or adjust, as appropriate, this Board of Directors Compensation Plan at the end of each calendar year, including with respect to whether to continue offering the choice under such plan between options and stock.  In accordance with the above, on January 4, 2012 the Company issued an aggregate of 410,000 options to purchase shares of our Common Stock at a per share exercise price of $0.52 and 580,000 shares of our Common Stock (120,000 of which were granted under the Company’s 2009 Non-U.S. Based Equity Compensation Plan (the “Non-US Plan”)).
 
On January 4, 2012, NeoStem granted under the 2009 Plan to certain employees, consultants and advisors options to purchase an aggregate of 3,116,552 shares of our Common Stock at a per share exercise price equal to $0.52 which was the closing price of the Common Stock on the date of grant.  In addition, 75,000 options were granted under the Non-US Plan.  Options to purchase a total of 1,841,400 shares were granted to executive officers. 

 
 
 

 

Item 7.01.   Regulation FD Disclosure.
     
NeoStem intends, from time to time, to utilize at various industry and other conferences two slide presentations. These slide presentations are accessible on NeoStem’s website at www.neostem.com and are being furnished as Exhibits 99.1 and 99.2 hereto. NeoStem undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 and 99.2.

The information under Item 7.01 in this Current Report on Form 8-K is being furnished pursuant to Item 7.01 of Form 8-K.  In accordance with General Instruction B.2 of Form 8-K, the information under Item 7.01 of this Current Report on Form 8-K, including, without limitation, Exhibits 99.1 and 99.2, shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.  The information in Item 7.01 of this Current Report on Form 8-K, including, without limitation, Exhibits 99.1 and 99.2, shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.

Item 8.01.  Other Events.

On January 3, 2012, NeoStem issued a press release that included a letter to the shareholders of the Company.  A copy of the press release is attached as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference.

The Company is taking steps to limit its adult stem cell therapy services business in China, including decreasing the number of employees, including members of senior management.

On January 6, 2012, pursuant to a letter agreement (the “Letter Agreement”) entered into with Catherine M. Vaczy,  the Vice President, Legal and General Counsel for the Company, the Company extended Ms. Vaczy’s employment agreement dated January 26, 2007, which employment agreement was amended on January 9, 2008, August 29, 2008, July 8, 2009 and July 7, 2010 (the “Original Agreement ”).  The Letter Agreement is effective as of January 6, 2012 (the “Effective Date”) and continues through December 31, 2012 (the “Term”).  In consideration for Ms. Vaczy’s services during the Term, Ms. Vaczy shall continue to receive her base salary of $232,500 through July 7, 2012 at which time such salary shall be increased by 10%.

Upon the Effective Date, Ms. Vaczy  received an option grant for 150,000 shares of Common Stock under the 2009 Plan with an exercise price equal to the closing price of the Common Stock on the date of grant, which option shall vest as to all shares upon the expiration of the Term.  Options granted to Ms. Vaczy shall remain exercisable for a period of two years following her termination of employment with the Company.  Under the Letter Agreement, Ms. Vaczy also agreed to accept $10,000 of the $30,000 portion of her 2011 bonus payable in shares of the Company’s Common Stock on a net basis, based on the closing price of the Company’s Common Stock on the Effective Date, and the vesting was accelerated for 50,000 unvested options held by her.
 
 
 

 

 
Forward-Looking Statements
 
This Current Report on Form 8-K, including Exhibits 99.1, 99.2 and 99.3 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's judgment regarding future events.  Although the Company believes that 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 statements of historical fact included in the 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.  

Item 9.01.   Financial Statements and Exhibits.

         (d) Exhibits.
     
Exhibit No.
 
Description
99.1
 
Investor Presentation of NeoStem, Inc. dated January 2012*
     
99.2
 
Cell Therapy Presentation of NeoStem, Inc. dated January 2012*
     
99.3
 
Press release of NeoStem, Inc., dated January 3, 2012

*Exhibits 99.1 and 99.2 are furnished as part of this Current Report on Form 8-K. 
 
 
 
 
 

 

 
 
SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, NeoStem has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


 
NEOSTEM, INC.
 
     
       
 
By:
/s/ Catherine M. Vaczy
 
 
 
Name: Catherine M. Vaczy
 
 
 
Title: Vice President and General Counsel
 




Date:  January 6, 2012
 
 
 

 

NeoStem, Inc. (“NBS”) Investor Presentation January 2012

 
 

2 Included in this presentation are “forward - looking” statements within the meaning of the Private Securities Litigation Reform Ac t of 1995, as well as historical information. Such forward - looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual resu lts, performance or achievements of NeoStem, Inc. and its subsidiaries (collectively, the “Company”), or industry results, to be materially different from antici pat ed results, performance or achievements expressed or implied by such forward - looking statements. When used in this presentation, statements that are not statements of c urrent or historical fact may be deemed to be forward - looking statements. Without limiting the foregoing, the words "plan," "intend," "may," "will," "expect," "believe, " "could," "anticipate," "estimate," or "continue" or similar expressions or other variations or comparable terminology are intended to identify such forward - looking st atements, although some forward looking statements are expressed differently. Additionally, statements regarding our ability to successfully develop, integrate and g row the businesses at home and abroad, including with regard to the Company’s research and development efforts in cellular therapy, its adult stem cell and umbilica l c ord blood collection, processing and storage business, contract manufacturing and process development of cellular based medicines, and the pharmaceuticals manufacturing o per ations conducted in China, the future of regenerative medicine and the role of stem cells in that future, the future use of stem cells as a treatment option and th e r ole of VSEL™ Technology in that future and the potential revenue growth of such businesses, are forward - looking statements. Our future operating results are dependent upo n many factors and our further development is highly dependent on future medical and research developments and market acceptance, which is outside our contr ol. Forward - looking statements, including with respect to the successful execution of the Company’s strategy, may not be realized due to a variety of factors an d we cannot guarantee their accuracy or that our expectations about future events will prove to be correct. Such factors include, without limitation, ( i ) our ability to manage the business despite operating losses and cash outflows; (ii) our ability to obtain sufficient capital or strategic business arrangements to fund our operations and ex pan sion plans, including meeting our financial obligations under various licensing and other strategic arrangements and the successful commercialization of the relev ant technology; (iii) our ability to build the management and human resources and infrastructure necessary to support the growth of the business; (iv) our ability to integr ate the Company’s acquired businesses successfully and grow such acquired businesses as anticipated; (v) whether a large global market is established for our cellu lar - based products and services and our ability to capture a share of this market; (vi) competitive factors and developments beyond our control; (vii) scientific and medical de velopments beyond our control; (viii) our ability to obtain appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regu lat ions or any other adverse effect or limitations caused by government regulation of the business; (ix) whether any of our current or future patent applications result in issu ed patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; (x) whether any potential strategi c b enefits of various licensing transactions will be realized and whether any potential benefits from the acquisition of these licensed technologies will be realized; (xi) the results of our development activities, including the timing, enrollment, outcome and/or results of any clinical trials; (xii) our ability to successfully divest our 51% ownership of our Erye subsidiary; (xiii) factors regarding our business and initiatives in China and, generally, regarding doing business in China, including through our variable interest entity structure, including (a) costs related to funding these initiatives, (b) the successful application under Chinese law of the variable interest entity structure to the Com pany’s business, which structure the Company is relying on to conduct its business in China, (c) the ability to integrate the Company and the business operations in China su ccessfully and grow such integrated businesses as anticipated, (d) the need for outside financing to meet capital requirements, and (e) the ability of the Company to realiz e o n its investment in Erye through distributions, divestiture or other strategic alternatives; and ( xiv) other risk factors disclosed in the Company’s definitive proxy statement filed September 16, 2011 and in the Company’s periodic filings with the Securities and Exchange Commission which are available for review at www.sec.gov under “Search for Company F ili ngs.” All forward - looking statements attributable to us are expressly qualified in their entirety by these and other factors. We under take no obligation to update or revise these forward - looking statements, whether to reflect events or circumstances after the date initially filed or published, to reflect t he occurrence of unanticipated events or otherwise, except to the extent required by federal securities laws. The contents of this PowerPoint presentation reflect the merger of Amorcyte , Inc., a clinical stage therapeutics company pursuing cell - based therapies for cardiovascular diseases, with and into a wholly - owned subsidiary of NeoStem, which closed on October 17, 2011. Forward - Looking Statements

 
 

3 Cell Therapy Pipeline Regenerative Medicine VSEL TM Technology Cardiovascular Amorcyte P1 Asset T - Reg Cells: Restoring Immune Balance Preclinical Asset VSELs™: Pluripotent Adult Stem Cells P2 Asset AMR - 001: Cardiovascular Disease Autoimmune Athelos NeoStem is a global cell therapy company with a strategic combination of revenues that is focused on transforming chronic disease through cell based medicine. We have a clinical philosophy based on traditional drug development with state of the art manufacturing and high level regulatory expertise NeoStem: A Leader in Cell Therapy

 
 

4 Commercial Scale Manufacturin g • Industry leader in commercial cell therapy manufacturing • 50,000 square feet of cGMP manufacturing capability located in North America and China • Manufactured 30,000+ cell therapy product procedures and delivered 6,000+ cell therapies to patients worldwide for over 100 clients • Cost - efficient cell therapy development platform • Diversified revenue stream from cell therapy manufacturing contracts

 
 

5 Progenitor Cell Therapy: Extensive Pipeline • PCT has experience with virtually every cell type including dendritic cells (7 years of manufacturing for Provenge ®) • Partnering relationships with a goal of commercial manufacturing • Active companies in the cell therapy space include: Preclinical I II III Mkt PCT has experience working at all developmental stages

 
 

6 • An autologous pharmaceutical grade product: purified and enriched natural cell population derived from patients’ bone marrow and intended to preserve heart muscle function and limit MACE following acute myocardial infarction • Clinical biologic dosing threshold established in clinical trial • Defined mechanism of action: CD34 + CXCR4 + homing & integration • Dominant IP position with both composition of matter and method patents • Pharmacoeconomic value

 
 

7 7 7 • Of the 800,000 annual AMI patients in U.S., 20% (160,000) are STEMI, and experience progressive deterioration in heart muscle function leading to: • Premature Death • Recurrent Myocardial Infarction • Congestive Heart Failure Clear Unmet Medical Need for AMI Patients References: American Heart Association Quyyumi AA et al 2011, American Heart Journal; 161(1) 98 - 105 • Inadequate perfusion ( microvascular insufficiency) leads to hibernating cardiomyocytes and progressive cardiomyocyte loss due to apoptosis

 
 

8 Cell Type: CD34⁺CXCR4 + Cells are a Natural Repair Mechanism • A distress signal (HIF) is induced by hypoxia in the peri - infarct zone • HIF induces synthesis of SDF and VEGF, which mobilize CD34 + CXCR4 + cells • The mobilized cells are trophic to the peri - infarct zone, preventing apoptosis through paracrine effects and effecting neoangiogenesis The body attempts to rescue damaged tissue to prevent ventricular remodeling: CD34+/CXCR4+ SDF Gradient CD34+ cell laying down new blood vessels AMR - 001: Highly purified (CD34 + ) and active (CXCR4 + ) cell population

 
 

9 PreSERVE AMI Trial for AMR - 001 • Patient presents with chest pain + STEMI • All enrolled patients receive a stent • If ejection fraction (EF) ≤ 48%, patient is enrolled in trial & randomized for treatment Day 1 Day 4 • Patient bone marrow harvested • CD34 + CXCR4 + isolated using proprietary technology • Intracoronary infusion of CD34 + CXCR4 + cell product (treatment arm) or media (control arm) Day 5 - 8 6 - 8 Hour Cell Separation Process Ventriculography 9 CMR Day 6 - 10 6 Months Follow - up : Cardiac function measures by SPECT MPI and MRI with MACE Follow - up Primary endpoint of RTSS and a host of secondary measures to assess the impact of AMR - 001 on infarct size and cardiac function. These will include left ventricular ejection fraction (LVEF), (preservation and change), end systolic and end diastolic volumes, regional myocardial str ain and regional wall motion. QOL will be measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Seattle Angina Questionnaire (SAQ) administered at baseline, 6 and 12 months post randomization. Clinical outcomes include major adverse cardiac events (MACE) and changes in NY HA classification at 6 months, one year, 18 months, two years and three years. MACE are defined as cardiac mortality, hospitalization for worsening hea rt failure and recurrent acute myocardial infarction (AMI). In addition, clinical events including ventricular arrhythmias requiring intervention, acute coronary syndrome (ACS), and revascularization (PCI, CABG) will be assessed at 6 months, one year, 18 months, two years and three years. All - cause mortal ity will be assessed as will be the number of days alive and out of the hospital at 6 and 12 months. Injection into the IRA

 
 

10 AMR - 001 Phase 1 Clinical Trial Protocol 10 Indication Post - AMI with LVEF ≤50% and wall motion abnormality in the myocardium of the IRA Primary Endpoint Safety in post - AMI patients Other Endpoints RTSS* (Perfusion); LVEF; ESV; SDF mobility Key Inclusion Criteria Confirmation of ST Elevation MI; Ejection fraction ≤ 50% Dosing Frequency Single dose Groups and Randomization 3 dose cohorts (5, 10, 15 million cells, randomized 1:1) Number of Subjects N=31 Number of Sites 4 Geography United States Trial Duration 6 months Quyyumi AA et al 2011, American Heart Journal; 161(1) 98 - 105 *RTSS: Resting Total Severity Score

 
 

11 11 11 Dose Response Established Y = Δ Infarct % LV Mass, X = Dose of SDF1 mobile CD34 cells Increasing doses of AMR - 001 reduced the size of the infarct region by CMR Increasing doses of AMR - 001 reduced RTSS ( hypoperfusion ), and improved perfusion Y= Δ RTSS, X = Dose of SDF1 mobile CD34 cells Quyyumi AA et al 2011, American Heart Journal; 161(1) 98 - 105

 
 

12 12 12 Threshold Dose for Efficacy Established RTSS ( Hypoperfusion ) Baseline correlates with infarct size Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 - 362.8 - 36.4 15M Cells 584.0 462.0 - 122.0 - 20.9 Patients dosed ≥ the threshold dose of 10 million cells showed significant improvement in perfusion DSMB determined that no adverse events were related to therapy Quyyumi AA et al 2011, American Heart Journal; 161(1) 98 - 105 RTSS: Resting Total Severity Score

 
 

13 13 13 Subgroup Analyses: Additional Cardiac Function Test Results RTSS ( Hypoperfusion ) 6 month Base Line 6 Mo. Δ % Δ Below Threshold 385.4 398.1 +12.6 +3.3 Above Threshold 814.3 558.6 - 255.8 - 31.4 (p=0.01)* * change in 10M/15M cells cohorts significant compared to 5M cells/Control cohorts Ejection Fraction 6 month BL 6 Mo. Δ % % Δ Below Threshold 51.0 51.8 0.7 +1.3 Above Threshold 48.2 52.7 +4.5 +9.4 End Systolic Volume 6 month BL 6 Mo. Δ ml % Δ Below Threshold 77.7 81.3 +3.6 +4.6 Above Threshold 94.1 88.4 - 5.7 - 6.1 The overall composite data and individual scores (EF) support potential best in class product Drop in Ejection Fraction 30% 40% Above Threshold Ejection Fraction [ Improvement +9.4% ] Quyyumi AA et al 2011, American Heart Journal; 161(1) 98 - 105

 
 

14 PreSERVE AMI Trial Phase 2 Clinical Plan 14 Indication Post - AMI Preservation of Cardiac Function Primary Endpoint Increased Cardiac Perfusion (RTSS) measured by SPECT Other Endpoints A composite of endpoints will be used to determine overall cardiac function (including preservation of LVEF and prevention of adverse remodeling) and Quality of Life (KCCQ & SAQ*) Safety Reduction in cumulative MACE and other adverse events at 6, 12, 18, 24, and 36 months Dosing Frequency Single dose Dosing and Randomization Minimum dose for release > 10m cells Randomized 1:1 treatment to sham placebo control Number of Subjects 160 patients Number of Sites 34 Geography United States Trial Duration Perfusion, cardiac function and QOL at approximately 18 months post first enrollment (12 months of enrollment and 6 months of treatment) * KCCQ: Kansas City Cardiomyopathy Questionnaire SAQ: Seattle Angina Questionnaire

 
 

15 15 15 Clinical Development Stage PII PII PI PI PII PII PII PI PII Field of Use AMI AMI AMI AMI AMI AMI HF HF CMI Defined Mechanism of Action x x x x x Autologous x x x x x x Potential Toxicities /Safety Signals x x x Centralized Manufacturing x x x x x x x x cGMP Defined Product x x x x x x x Threshold Dose x x x x x Cells Expanded x x x x Strong IP x AMI = Acute Myocardial Infarction HF = Heart Failure CMI = Chronic Myocardial Ischemia AMR - 001 Advantages in the Landscape AMR - 001 Advantages • Functionality of CD34 + CXCR4 + cells • Confirmed mechanism of action • cGMP processing and manufacturing that stabilizes the CD34 + CXCR4 + cells • Potency, viability, stability, sterility, and variability assays • Threshold dose is established at 10 million cells • Dominant IP • composition of matter • methods and processes • catheter delivery

 
 

16 16 16 Pharmacoeconomic Impact • Adverse left ventricular remodeling after STEMI results in an average medical burden of ≥ $50K per patient, per year of life • If the patient’s LVEF declines below 40%, then the cost per year escalates for the balance of the patient’s lifetime • AMR - 001 is designed to prevent a decline in LVEF, thereby limiting adverse left ventricular remodeling and its negative consequences • Pricing will allow strong commercial margins while significantly reducing costs to the health care system Therapy Stem Cell Product Acquisition Charge US International Total Cost of Therapy Bone Marrow $26,090 $41,555 $125 – 150,000 Peripheral Blood (PBSC) $25,620 $41,645 $85 - $125,000 Cord Blood Transplant $34,045 $43,025 $150 – 300,000 Provenge ® $93,000 (3Trt) Not Available AMR - 001 TBD TBD TBD

 
 

17 Additional Potential Indications for AMR - 001 • AMR - 001 platform can be applied to other conditions resulting from underlying ischemia • Chronic Myocardial Ischemia post - AMI • Cardiomyopathy : – Ischemic – Chemotherapy Induced • Congestive Heart Failure • Critical Limb Ischemia • Cryopreserved preparations of AMR - 001 AMR - 001 platform can be applied to other conditions resulting from underlying ischemia • AMR - 001: Composition of matter patent (2028) • NeoStem’s patent estate includes patents for Amorcyte , Athelos & VSELs™ Over 30 issued patents and over 90 pending patent applications, including composition of matter and methods claims. Geographic breadth of filings includes North America, Europe, Asia, Australia, Israel and South Africa

 
 

18 18 18 Athelos: T - reg Cells - Restoring Immune Balance • Partnership with Becton Dickinson which owns 20% of the Athelos subsidiary • Immune mediated diseases, such as GVHD, autoimmune diseases and allergic diseases, are a result of an imbalance between T - effector cells and T - regulatory cells (T - reg ) • T - reg therapy represents a novel approach for restoring immune balance by enhancing T - regulatory cell number and function • T - reg cells are collected by apheresis , isolated using surface markers (for example: CD4+, CD25+, FoxP3+), activated and expanded ex vivo approximately 500 fold in 20 days 1 • Phase 1 work is ongoing globally under several independent physician INDs, results of which will inform NeoStem’s future clinical direction 1) Chai, Jian - Guo et al, Journal of Immunology 2008; 180;858 - 869

 
 

19 19 19 VSEL™ Pluripotent Adult Stem Cells heart neuron pancreas VSEL™ • VSEL™ (Very Small Embryonic - Like) technology is NeoStem’s proprietary adult stem cell technology platform • Believed to be naturally pluripotent – no manipulation required • iPSCs (induced pluripotent stem cells) are recognized as manipulated and destroyed by the immune system (even as an autologous product) • VSELs™ have been shown in animal research to home to sites of injury, up - regulate angiogenesis, down - regulate inflammation (the “paracrine effect”), BUT, importantly, go one step further and differentiate into target cell types VSELs™ potentially represent the most powerful regenerative cell as they are pluripotent, autologous, “ natural,” powerful “paracrine” cells. Rodgerson DO, Harris AG, “A Comparison of Stem Cells for Therapeutic Use”, Stem Cell Rev. 2011 Mar 2.

 
 

20 20 20 Financial Highlights Key Metrics as of September 30, 2011 Revenue $56.0m (nine months ended 9/30/11) Cash Position $15.6m* Net Loss Excluding Non - Cash Charges $10.0m (nine months ended 9/30/11)* Total Stock and Equivalent Shares Common Shares 100.4m Options 17.7m Warrants 35.2m Series E Preferred Stock 4.7m *See Appendix for GAAP to Non - GAAP reconciliation

 
 

21 21 21 Key Executives Robin Smith, MD, MBA CEO & Chairman of the Board  MD – Yale; MBA – Wharton  Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management)  Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases (through November 2009) and Stem for Life Foundation Larry May Chief Financial Officer  BS Business Administration – University of Missouri  Formerly Treasurer & Controller at Amgen; SVP Finance & CFO at BioSource Intl  Extensive experience building accounting, finance and IT operations Jason Kolbert, MBA VP of Strategic Business Development  BS Chemistry – SUNY New Paltz, MBA - University of New Haven  17 years experience on Wall Street as Research Analyst in biotechnology in US and Asia  6 years in the pharmaceutical industry with Schering-Plough in Japan Andrew Pecora, MD, FACP Chief Medical Officer  MD – University of Medicine and Dentistry of New Jersey  Chief Innovations Officer, Professor and Vice President of Cancer Services at John Theurer Cancer Center at Hackensack University Medical Center Robert Preti, PhD President and Chief Scientific Officer of PCT  PhD and MS in Cellular Biology / Hematology - New York University  One of the country’s leading authorities on cell engineering and the principal investigator for a number of clinical trials relating to stem cell transplantation  10 years experience as Director of Hematopoietic Stem Cell Processing & Research Laboratory Jian Zhang General Manager, Suzhou Erye Pharmaceuticals Co., Ltd  Joined Erye in 2003; extensive experience in the Chinese pharmaceutical industry  Degree in Finance and Accounting from Central Television University  Certified Public Accountant in China

 
 

22 22 22 • First patient enrollment in PreSERVE AMI Phase 2 trial (Q1 2012 ) • Expansion of intellectual property beyond cardiovascular disease (Q1 2012) • Start of AMR - 001 trial in congestive heart failure (2012) • Athelos – data read - out from investigator sponsored P1 trials in GVHD, diabetes, solid organ transplant, and asthma (2012) • Presentation of VSEL TM Technology data at American Society of Hematology Annual Meeting by SAB member, Dec. 10 - 13, 2011 • Monetization of 51% ownership in Suzhou Erye (2012) • Data readouts for PreServe AMI Phase 2 Trial (Q3 2013) • Additional government research grants Recent and Expected Milestones

 
 

23 23 23 Questions

 
 

24 24 24 Board of Directors Robin Smith, MD, MBA CEO & Chairman of the Board  MD – Yale; MBA – Wharton  Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management)  Experience - Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases (through November 2009) and Stem for Life Foundation Richard Berman (Independent)  Over 35 years of venture capital, management, M&A experience  Experience – Current Board of Directors of Apricus Biosciences, Easylink Services International, Inc., Advaxis, Inc., Broadcaster, Inc., National Investment Managers Drew Bernstein, CPA (Independent)  BS – University of Maryland Business School  Licensed in State of New York; member AICPA, NYSSCPA and NSA  Experience – Bernstein & Pinchuk LLP (member of BDO Seidman Alliance); PRC auditing; 200+ real estate transactions with $3B+ aggregate value; accountant and business advisor Edward Geehr, MD (Independent)  BS – Yale University; MD – Duke University  Experience – Abraxis Bio-Science; Allez Spine; IPC-The Hospitalist Company Martyn Greenacre, MBA (Independent)  BA – Harvard College; MBA – Harvard Business School  Experience – Board and executive positions for multiple biopharmaceutical companies; Former CEO of Delsys Pharmaceutical Corporation and Zynaxis Inc; Chairman of the Board of BMP Sunstone Corporation Steven Myers (Independent)  BS Mathematics – Stanford University  Experience – Founder/Chairman/CEO SM&A (competition management services); career in aerospace and defense sectors supporting DoD & NASA programs Andrew Pecora, MD, FACP  MD — University of Medicine and Dentistry of New Jersey  Experience – Chief Innovations Officer, Professor and Vice President of Cancer Services at John Theurer Cancer Center at Hackensack University Medical Center, and Managing Partner of the Northern New Jersey Cancer Center Mingsheng Shi Chairman of the Board of Suzhou Erye Pharmaceutical  BSc Economics & Management – Party School of the Communist Party of China  Professional title of Senior Economist  Extensive experience in pharmaceutical industry in China Eric Wei Managing Partner, RimAsia Capital Partners  BS Mathematics & Economics – Amherst College; MBA – Wharton  Experience – Founder/Managing Partner of RimAsia Capital Partners (private equity); Peregrine Capital, Prudential Securities, Lazard Freres, Citibank; Gilbert Global Equity PartnersCrimson Asia Capital Partners NeoStem Board Members

 
 

25 25 25 Eugene Braunwald, MD, FRCP  Brigham & Women’s Hospital Bernard J. Gersh, MD, ChB, DPhil, FRCP  The Mayo Clinic Dean J. Kereiakes, MD, FACC  The Christ Hospital Heart of Greater Cincinnati Douglas L. Mann, MD, FACC  Washington University School of Medicine Andrew L. Pecora, MD, FACP, CPE  Chief Medical Officer, NeoStem  Hackensack University Medical Center Carl J. Pepine, MD  University of Florida College of Medicine Emerson C. Perin, MD, PhD, FACC  Texas Heart Institute Bertram Pitt, MD  University of Michigan School of Medicine Arshed Quyyumi, MD, FRCP, FACC  Principal Investigator, Phase II  Emory University School of Medicine Edmund K. Waller, MD, PhD, FACP  Emory University School of Medicine James T. Willerson, MD  University Texas Health Science Center Joseph Wu, MD, PhD  Stanford University School of Medicine Amorcyte Scientific Advisory Board

 
 

26 26 26 Athelos Scientific Advisory Board Robert A. Preti, PhD, Chairman  Progenitor Cell Therapy Bruce Blazar, MD  University of Michigan Masonic Cancer Center Jeffrey Bluestone, PhD  University of California, San Francisco, Diabetes Center David A. Horwitz, MD  University of Southern California Carl June, MD  Perelman School of Medicine, University of California Robert Korngold, PhD  Hackensack University Medical Center Wayne A. Marasco, MD, PhD  Dana-Farber Cancer Institute Robert S. Negrin, MD  Stanford University David Peritt, PhD  Hospira Camillo Recordi, MD  University of Miami Diabetes Research Institute Noel L. Warner, PhD  BD Biosciences

 
 

27 27 27 Appendix GAAP to Non-GAAP Reconciliations for the nine months ended September 30, 2011 Cash Position Reconciliation Cash & cash equivalents 11,713,338$ Short term investments 555 Restricted cash 1,427,827 Cash included in Other Assets 2,500,000 (represents cash held in escrow as security associated with Preferred Series E obligations, with maximum lock up through May 2013) Cash Position 15,641,720$ Net Loss Excluding Non-Cash Charges Reconciliation Net Loss (27,728,736)$ Non cash charge adjustments per Cash Flow Statement: Common stock, stock options and warrants issued 8,164,814 Depreciation and amortization 6,754,953 Amortization of preferred stock discount and issuance cost 1,903,703 Changes in fair value of derivative liability (1,661,049) Write off of acquired in-process research and development 1,150,000 Loss on disposal of assets 396,635 Non-cash interest expense 328,425 Contributions paid with common stock 607,363 Bad debt expense 50,024 Net Loss Excluding Non-Cash Charges (10,033,868)$

 

Alliance for Regenerative Medicine Robin Smith MD , MBA January 2012 Chairman & CEO A Paradigm Shift to Cell Therapy is Coming!

 
 

2 2 2 Capturing the Paradigm Shift to Cell Based Therapy

 
 

3 3 3 Cell Therapy Has Already Shown Promise Towards Unmet Therapeutic Needs • Provide exquisite control of glucose and insulin level (diabetes) • Immune tolerance regimens to combat autoimmunity • MS • Lupus • Osteoarthritis • GvHD • Solid organ rejection Reverse neurological damage Reset the immune system Central Nervous System Autoimmune Diseases • ALS • Spinal cord injury • Stroke • Neuro - degenerative Neo - vascularization and repair of damaged t issue Cardiovascular Disease • Prevent heart failure post STEMI • Restore failing heart function • Improve areas of vascular insufficiency • Disc repair • Cranial facial • Osteoporosis • Reconstruction post trauma Rebuild bone and repair cartilage Musculoskeletal 21,036 Cell Therapy Trials; 3,856 Stem Cell Therapy Trials; 1,065 Immunotherapy Trials* * Source: Clinicaltrials.gov What Does This Mean For Investors?

 
 

4 4 4 1980 1990 2000 1x 10x 100x 1000x 2010 Aggregate Industry Valuation Value Creation in the Biotechnology Industry Evolution of a Paradigm Shift Irrational Exuberance Reality Break - through Take Off First Recombinant Protein Therapeutic: Humulin ® First Recombinant Monoclonal Antibody: ORTHOCLONE ® First Recombinant Protein Centoxin ® Fails in Ph 3 EPOGEN ® Approved Neupogen ® Sales $1 bn REMICADE ® Approved 10 th Monoclonal Antibody Approved INFUSE ® Approved

 
 

5 Must Demonstrate Ability to Reduce Cost, Time and Risk of Cell Therapy Development • Autologous vs. Allogeneic • Patient - specific vs Multi - patient Use • Sources of cells: Bone marrow derived, adipose, IPS, Embryonic, etc. • Fresh vs Cryopreserved • Shelf - life from sourcing to therapy (logistics considerations) • Changes control through scale - ip (SOPs and Manufacturer) • Pharmacoeconomic studies These Variables Directly Effect: • Regulatory pathway • Time of development • Cost of clinical trials • Affordability / Cost of Goods • Reimbursement • Adoption by medical community

 
 

6 Cell Therapy : Opportunities & Challenges in 2012 • A paradigm s hift in cell t herapy is coming as evidenced by the number of products in later stage trials. • Hundreds of millions of dollars in federal funding has been allocated and distributed for regenerative medicine research (ARM, TATRC, CDMRP). • Aastrom , Athersys , Pluristem , Tengion , Immunocellular , NeoStem, Stem Cells Inc., and Coronado (just to name a few) have raised over $150 million collectively, but valuations are now low and the financing environment is tough. • Strategic Investments are Rising: Mesoblast & Cephalon , PluriStem and United Therapeutics, Athersys & Pfizer, Osiris & Genzyme, however pharmaceutical companies and large biotechs are becoming more risk adverse and want proof of principle from well designed clinical programs. • The key is to weather the storm and survivors will be those who understand how to leverage themselves to the environment, utilize resources, and be cost effective.

 
 

7 NeoStem’s Approach Therapeutics Development Services Division Manufacturing & Family Banking • Autologous Stem Cell based Therapeutic for Cardiovascular Disease ( Amorcyte ) • T - Regulatory Program for Auto - Immune Disorders and GVHD & Solid Organ Rejection ( Athelos ) • Regenerative Medicine Program U sing Autologous VSELs TM Revenues NeoStem is uniquely positioned for success with a strategic combination of revenues and a pipeline of cell based therapies focused on transforming chronic disease.

 

Unassociated Document
EXHIBIT 99.3
NeoStem’s CEO Letter to Shareholders

 
NEW YORK , Jan. 3, 2012 /PRNewswire/ --
 
 
Dear NeoStem Shareholders,
 
We would like to take a moment to both look back at 2011 - a transformative year for NeoStem (NYSE Amex: NBS) – and to look ahead to near term catalysts that we expect to move the company forward in 2012 and beyond.
 
·  We have closed two acquisitions - Progenitor Cell Therapy, LLC ("PCT") and Amorcyte, LLC ("Amorcyte").

·  We believe our therapeutic product development team is very close to accomplishing its aggressive goal of getting a first patient enrolled in our AMR-001 Phase 2 clinical trial for the treatment of AMI with the clinical sites beginning to open.  This brings us closer to achieving our goal of enrollment of the targeted 160 patients in the study over the next year or so with first data follow-up six months after the last patient is enrolled (roughly mid-2013).

·  Our cell therapy manufacturing business is growing and client satisfaction confirms our belief and excitement that we have unique skills and people (expertise, quality and work ethic) to serve as a platform to be a global leader in the cell therapy space.

·  We raised $16.5 million in gross proceeds in 2011 for working capital, including research and development of our cell therapeutic candidates.

·  We received awards of over $1.7 million in Department of Defense funding for development of our VSELTM Technology to treat osteoporosis and $245,176 from the National Institutes of Health (NIH) with Excell Therapeutics to progress our T regulatory program in Lupus. 

·  We co-hosted a spectacular international conference in partnership with the Vatican's Pontifical Council for Culture on Adult Stem Cells: Science and the Future of Man and Culture, moving forward the public discussion of adult stem cells and adult stem cell research.

·  Our cord blood banking enrollment more than doubled over the previous year.

·  We have been marketing our ownership in Suzhou Erye Pharmaceutical Co. Ltd. subsidiary for possible sale.

·  We have positioned our intellectual property portfolio to expand beyond the current indications and give us a strong position in the cell therapy arena.
 
 
 

 

 
·  We continue to make great headway in integrating IT systems, legal, finance, and marketing for our multiple entities to achieve cost savings and maximize efficiencies.

·  NeoStem gained a significant pharmaceutical partnership with Becton Dickinson through our co-ownership of Athelos, Inc. (80% NeoStem, 20% BD). We are actively pursuing additional strategic relationships with major pharmaceutical and biotechnology companies in 2012.
 
We look forward to keeping you updated and encourage your questions via the contact information below. I also encourage you to learn more by visiting our company websites, www.neostem.com, www.amorcyte.com, and www.progenitorcelltherapy.com, our social media outlets, and our company blog at thechairmansblog.com/robin-l-smith. Thank you for your continued support of NeoStem and our ongoing transformation.
 
 
Sincerely,
 
 
Dr. Robin L. Smith
Chairman and CEO
 
For more information, please contact:
   
Trout Group
NeoStem, Inc.
Gitanjali Jain Ogawa, Vice President
Robin Smith, CEO
Phone: +1-646-378-2949
Phone: +1-212-584-4174
Email: gogawa@troutgroup.com  
Email: rsmith@neostem.com
   
 
About NeoStem, Inc.
 
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, poised to commence enrollment of patients in a Phase 2 trial for the preservation of heart function after a heart attack.  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 is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today.
 
 
 

 
 
For more information on NeoStem, please visit www.neostem.com and thechairmansblog.com/robin-l-smith.
 
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 and its divestiture of its interest in Erye Pharmaceutical Co., 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.