UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 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): October 31, 2006
NEOSTEM,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
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0-10909
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22-2343568
|
|
(State
Or Other
|
(Commission
|
(IRS
Employer
|
|
Jurisdiction
Of
|
File
Number)
|
Identification
No.)
|
|
Incorporation)
|
|
420
Lexington Avenue, Suite 450
|
|
|
New
York, New York
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10170
|
|
(Address
of principal executive offices)
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(Zip
Code)
|
Registrant's
telephone number, including area code: (212)-584-4814
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):
[
] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[
] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[
] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item
7.01. Regulation
FD Disclosure.
NeoStem,
Inc. (the “Company”), is furnishing presentation materials, included as Exhibit
99.1 to this current report and incorporated into this item by reference, which
will be used by the Company at a healthcare conference on November 6,
2006.
Item
9.01. Financial Statements and
Exhibits.
(d)
Exhibits.
Exhibit
99.1 Presentation
to Investors
SIGNATURE
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.
| NEOSTEM, INC. | ||
| |
|
|
| By: | /s/ Catherine M. Vaczy | |
| Catherine M. Vaczy | ||
| Vice President and General Counsel | ||
Dated:
October 31, 2006
Exhibit
99.1
First
Long-Term Autologous Adult Stem Cell Storage Bank First Long-Term Autologous
Adult Stem Cell Storage Bank NEOI.OB
FORWARD
LOOKING STATEMENTS This presentation contains “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995.
Such
forward-looking statements involve known and unknown risks, uncertainties
and
other factors which may cause the actual results, performance or achievements
of
NeoStem, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. When used in this presentation, statements that
are
not statements of current or historical fact may be deemed to be forward-looking
statements. Additionally, statements concerning: the Company’s ability to
develop the adult stem cell business, the future of regenerative medicine
and
the role of adult stem cells in that future, the future use of adult stem
cells
as a treatment option and the potential revenue growth of such business are
forward-looking statements. The Company’s ability to enter the adult stem cell
arena and future operating results are dependent upon many factors including
but
not limited to (i) the Company’s ability to obtain sufficient capital or a
strategic business arrangement to fund its expansion plans; (ii) the Company’s
ability to build the management and human resources and infrastructure necessary
to support the growth of its business and obtain appropriate state and other
licenses; (iii) competitive factors and developments beyond the Company's
control; (iv) scientific and medical developments beyond the Company’s control
and (v) other risk factors discussed 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 Filings.” You are cautioned not to place undue
reliance on these forward looking statements, which speak only as of the
date
hereof.
Over
40 million Americans suffer from Congestive Heart failure, Coronary Artery
Disease, Diabetes, Osteoporosis, Rheumatoid Arthritis, and Systemic Lupus
Erythomatosis All of them should have their Stem Cells banked for future
therapeutic treatments!
NeoStem
Offers Adults: • The ability to collect their stem cells through a painless
non-invasive technique • The ability to keep them stored in packaging so that
there can be multiple uses later in life • The ability to have Stem Cells
immediately available for future therapies that they will not reject, because
they originate from themselves - no Graft vs. Host disease
This
is Bio-Insurance Be prepared for regenerative medicine…
Stem
Cell -PRIMITIVE AND THUS UNSPECIALIZED -SELF-RENEWING -CAN DIFFERENTIATE
INTO
CELLS WITH SPECIFIC FUNCTIONS Stem Cell -PRIMITIVE AND THUS UNSPECIALIZED
-SELF-RENEWING -CAN DIFFERENTIATE INTO CELLS WITH SPECIFIC FUNCTIONS Ectoderm
Ectoderm Mesoderm Mesoderm Endoderm Endoderm Cardiac Skeletal Renal Muscle
Blood
Etc. Cardiac Skeletal Renal Muscle Blood Etc. Lung Gut Thyroid Pancreas Etc.
Lung Gut Thyroid Pancreas Etc. Skin Hair Brain Nerves Etc. Skin Hair Brain
Nerves Etc. Stem Cells and Pluripotency Progenitor Cells Progenitor
Cells
Embryonic
Stem Cells Typically derived from 4-5 day old embryos and are a hollow
microscopic ball of cells called the Blastocyst No current therapeutic
uses
Adult
Stem Cells An Adult Stem Cell is an undifferentiated cell found among
differentiated cells in a tissue or organ The principal sources of Adult
Stem
Cells are: Cord Blood Bone Marrow Peripheral Blood Numerous current therapeutic
uses
Nature
418; 4 July 2002
Diseases
Treatable with Stem Cells TODAY • Leukemias • Lymphoma • Multiple Myeloma •
Coronary Heart Disease • Radiation Sickness • Anemia • Tissue Repair & Burns
FUTURE POSSIBILITIES • Spinal Cord Injuries • Stroke • Parkinson Disease • Lou
Gehrig’s Disease (ALS) • Breast and Ovarian Cancer • Diabetes • Osteoporosis •
Autoimmune Diseases - Multiple Sclerosis (MS) - Systemic Lupus Erythematosus
(SLE) - Rheumatoid Arthritis (RA) • Amyloidosis • Sickle Cell Anemia •
Orthopedics
Outside
the U.S. Japan: Treated babies with cardiac malformations with Adult Stem
Cells
Germany, Thailand, Switzerland, Russia & India: Treated heart disease with
Adult Stem Cells (Dr. Patel from the University of Pittsburg Medical Center
flew
overseas to treat singer Don Ho) Argentina: Treated Type 2 diabetes with
Adult
Stem Cells (66% were able to stop taking insulin and oral
drugs)
Companies
Focused on Adult Stem Cell Therapeutics Adult Stem Cells to treat Crohn’s
Disease Osiris Adult Stem Cells from bone marrow to treat patients with Sickle
Cell Cellerent Therapeutics Placental stem cells for wound healing Stemnion
Adult Stem Cells from testes are being reprogrammed to create human heart,
brain
and bone cartilage Prime Cell Therapeutics
Clinical
Trials • 549 Clinical Trials using Stem Cells • 162 Clinical Trials using
Autologous Stem Cells Source: www.clinicaltrials.gov
Acute
Myocardial Infarction Trials
Auto
Bone-Marrow Treatment for Severe Autoimmune Disease • Fassas (J. Neurol. 2002)
Rx 188 pts with MS including 99 pts 2nd progressive, 19 primary progressive,
41
relapsing forms - 34 % sustained improvement • Snowden (J. Rheumatol. 2004) All
78 pts with RA showed significant improvement, 10% remained drug free, 73%
easily controlled by drugs • Burt (JAMA 2006) Rx 48 pts with severe SLE, 5 year
survival 84%, disease-free 5 yr survival 50%
Autologous
bone-marrow derived cells were used in the treatment of 3 patients with
non-healing chronic wounds. ♦Complete closure and evidence of dermal rebuilding
♦Clinical and histologic evidence of reduced scarring Evangelos V. Badiavas
and
Vincent Falanga. Arch.Dermatol. 139:510, 2003
Treatment
of Chronic Wounds With Bone-Marrow Derived Cells Hernigou P et al. J Bone
&
Joint Surg 87A: 1430, 2005 Fracture Fracture N o n u n i o n N o n u n i
o n 1 m
p o s t B M S C 1 m p o s t B M S C 2 m p o s t B M S C 2 m p o s t B M S
C 3 m
p o s t B M S C 3 m p o s t B M S C Percutaneous Autologous Bone Marrow Grafting
for Nonunions
Radiation
Sickness (Hematopoietic Syndrome) At 3.5 Gy 50% will die within 60 days w/o
intervention Primary cause of death is infection Individuals exposed to 0.7
-
4.0 grays (Gy) will develop syndrome Rescue through Stem Cell transplant
-
treatment of choice Success rate very high when administered within 7-10
days
following exposure Banking Stem Cells for autologous use critical to First
Responders, Military, etc.
Autologous = Self Allogeneic = Non-Self • Odds of finding compatible Stem Cell donor match is 1 in 100,000 • 18% of those needing a match are able to find one from Bone Marrow Donor Registry
Stem
Cell Infusion (Transplant) Possible None HIV, Hepatitis etc. from Donor Slower
Faster Immune Recon. Slower Faster Engraftment Yes No Graft v. Host Yes No
Rejection Required Not Required Tissue Matching Autologous Autologous Allogeneic
Allogeneic Autologous vs. Allogeneic Stem Cells
NeoStem
• G-CSF (480 ug) Mobilization of Adult Stem Cells • Extracted using Apheresis -
Non-Invasive - Done in doctor’s office - Under 3 hours • Stored in controlled
rate freezer (liquid nitrogen) • Collection includes Stem Cells, Progenitor
Cells, Mononuclear Cells • Stored in containers that allow multiple future
uses
NeoStem
Cell Processing and Storage
Intellectual
Property NeoStem has two pending U.S. patent applications describing key
aspects
of our process. These applications are: 1. Elective Collection and Banking
of
Autologous Peripheral Blood Stem Cells. Publication Number 20040258673,
Application Number 10/819,342, Priority Date April 2003 • This pending patent
application addresses the process by which NeoStem prepares and stores stem
cells collected from the peripheral blood by an aphaeresis process • Our
methodology is to separate primary stem cells and store them in numerous
aliquots in order to be used for individual diseaserelated therapies • This
enables the client to maintain sufficient primary stem cells in the bank
for
future use without the need and possible complications of in vitro stem cell
expansion. As a result, each collection results in multiple doses of stem
cells
Intellectual
Property (Cont.) 2. System Capable of Treating and Defining Various Disease
States Using Stem Cells. Publication Number 20040265281, Application Number
10/819,398 Priority Date April 2003 • This pending application addresses the use
of stored stem cells to form the basis for a data set that will provide
statistical information on the etiology of disease • The establishment of a
broad bank of stem cells will allow the Company to capitalize on the information
contained within these cells, which can be sold to pharmaceutical companies
in
connection with pre-clinical research and discovery • Each client is asked to
donate a small number of cells to this data bank There can be no assurance
that
either of these pending U.S. patent applications will ultimately issue as
patents
~$4,000/
yr. None Post -Tx Drugs <50% Not Applicable Match Avail. Very Low With
Storage Minority Avail. $300 - $500 K ~$50,000 Total Cost of Tx >$22,000
~$6,000 Cost of Cells 90 days (avg.) 1-2 days Time to Tx Long (>30 days)
Short (<5 days) Hospitalization Autologous Autologous Allogeneic Allogeneic
Appeal to Health Care System - $avings
Comparison
of Different Sources of Adult Stem Cells (D) Schoemans et al Bone Marrow
Transplantation 38:83, 2006 (C) Zubair et al Transfusion 44:253, 2004 (B)
Zeiher
(Schachinger et al) J. Amer. Coll. Cardiology 44:1690, 2004 (A) Badiavas
&
Falanga, Arch. Derm 139:510, 2003 *Primarily Buffy Coat **Whole Blood
***Estimate, no known published data .025 x 109 MNC/kg .00017 x 109 CD34+/kg
.0037 x 109 .75 x 109 75 ml Cord Blood .18 x 109 .016 x 109 .005 x 109 4
x
109*** 4 x 109 100ml to 1.2 liters Stem Cells from Adipose Tissue .18 x 109
.016
x 109 .005 x 109 .005 x 109 1 x 109 300ml** Micro Collections of Stem Cells
.05
x 109 MNC/kg (C) .0012 x 109 CD34+/kg .016 x109 .005 x 109 .1x109 28 x 109
300ml
Adult/ NeoStem Immune Reconstitution (C) Cardiac Repair (B) Diabetic Foot
Ulcers
(A) CD34+ Stem Cells Total Nucleated Cells Gross* Volume Published Dosage
Information Typical Collection
Long-Term
Viability of Stored Stem Cells One study has shown no significant loss of cell
viability in Stem Cells stored for up to ten years McCullough J, Clay M, Wagner
JE. Cord blood stem cells. In Ball ED, Lister J, Law P, editors: Hematopoietic
Stem Cell Therapy. Philadelphia: Churchill Livingstone, 2000:
287-297.
Comparables
All Numbers in Millions of Dollars All Numbers in Millions of Dollars All
Numbers in Millions of Dollars (10/24/06* Market Cap/Revenue/Net Income)
Comparable Public Companies (*Source Yahoo! Finance) Profit/(Loss) Sales
Market
Value Symbol (15.7) 44.4 191.9 (VIAC) ViaCell, Inc. (6.1) 12.0 226.7 (KOOL)
Thermogenisis Corp (33.5) 6.2 499.5 (GREN) Geron Corporation (26.5) 5.6 72.9
(CYTX) Cytori Therapeutics, Inc. 1.0 14.5 26.8 (CCEL) Cryo-Cell International,
Inc. (4.0) 0.0 8.0 (SSS) Stem Cell Therapeutics (12.0) 0.0 10.6 (RENE) ReNeuron
Holding PLC (15.5) 0.0 44.9 (OPXA) Opexa Therapeutics (formerly Pharmafrontier)
63.7 536.9 1,500.9B (CELG) Celgene Corporation (5.0) 1.3 4.9 (CLBE) CalbaTech
0.0 0.0 0.4 (BMSN) BioMatrix (9.4) 0.4 21.4 (ACTC) Advanced Cell Technology,
Inc. (11.7) 0.2 220.9 (STEM) StemCells, Inc. (6.1) 2.3 5.1 (CBAI) Cord Blood
America, Inc. (16.5) 0.9 163.7 (ASTM) Aastrom BioScience, Inc. (1.7) 0.0
16.6
(NEOI) NeoStem, Inc.
Potential
Market and Opportunity Prevalence Disease 204,999 diagnosed new cases per
year
Breast Cancer 253,000 Spinal Cord Injury 20.8 million Diabetes 200,000 Sickle
Cell Anemia 388,571 Multiple Sclerosis 5 million (550,000 new cases per year)
Congestive Heart Failure 6 million Coronary Artery Disease 2.1 million
Rheumatoid Arthritis 500,000 Crohns 1.4 million Lupus 4.7 million stroke
survivors (500,000 new cases per year) Stroke 1.5 million Parkinson 10 million
Osteoporosis 53,000,000 Potential NeoStem Clients Total 192155 Lymphoma &
Multiple Myloma 208,080 Leukemia Cord Blood and Placenta Market 4.2 million
births in U.S. annually 21 cord/placenta banking companies $200
million-dollar-a-year business
NeoStem
Milestones Over the last 5 months: • Closed on just under 4 million dollars •
10:1 Reverse stock split • Sustained post split increase in stock price •
Received License of California Stem Cell Bank • Signed first Collection Center
Agreement • Hired a seasoned Sales and Marketing Director Over the next 13
months: • Continue to expand management team with prominent medical and business
leaders • Assemble Advisory Board of Therapeutic Experts • Build Board of
Directors • Establish strategic relationships with pharmaceutical companies •
Partner with academic institutions • Add collection centers to network • Market
to those educated in the value of stem cells • Target populations of individuals
at risk for disease and exposure (e.g. first responders) who would benefit
from
Stem Cell storage • Launch 1-888-StemBank call center
28,718,129
227,204 Shares required for Convertible Promissory Notes 6,117,219 Warrants
2,895,998 Stock Options 19,477,708 Common Stock Shares Capitalization Table
October 18, 2006 NeoStem, Inc. Comp Table
Management/Directors/Senior
Staff • Robin Smith, M.D., MBA, NeoStem Chairman of the Board and CEO. Chairman
of Advisory Board for China Biopharmaceuticals (OTC BB: CHBP), Chairman of
NYU-Hospital for Joint Diseases • Mark Weinreb, NeoStem Director and President.
Former Owner, Bio Health Laboratories • Larry A. May, NeoStem Chief Financial
Officer. Former Treasurer, Amgen (NASDAQ: AMGN) • Wayne A. Marasco, M.D., Ph.D.,
NeoStem Director, Senior Scientific Advisor. Associate Professor- Department
of
Cancer and Immunology, Dana-Farber Cancer Institute, Associate Professor of
Medicine, Harvard Medical School • Julio C. Guerra, M.D., ABP, NeoStem Director
of Sales & Marketing. Former Senior VP of Marketing and New Program
Development of Anthrogeneis, which was bought by Celgene; formerly with Gerber,
Ross Products and Mead Johnson • Denis Rodgerson, Ph.D., NeoStem Director of
Stem Cell Science. Founder of NeoStem, Former Founder of StemCyte, Former Head
of Clinical Chemistry and Toxicology and Clinical Laboratory Computing, UCLA
Medical Center • George Smith, M.D., NeoStem Medical Director of Laboratory
Operations in California. Among his many distinguished career accomplishments,
Dr Smith is cofounder of UCLA Bone Marrow Transplant Center • Catherine M.
Vaczy, NeoStem VP & General Counsel. Former VP and Associate General
Counsel, ImClone (NASDAQ: IMCL) • Joseph Zuckerman, M.D., NeoStem Director.
Chairman of NYU-Hospital for Joint Diseases, Department of Orthopaedic
Surgery