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): August 30, 2006
NEOSTEM,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-10909
|
22-2343568
|
|
(State
Or Other Jurisdiction Of Incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
|
420
Lexington Avenue, Suite 450
|
|
|
New
York, New York
|
10170
|
|
(Address
of principal executive offices)
|
(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):
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
3.02. Unregistered
Sales of Equity Securities.
NeoStem,
Inc., formerly known as Phase III Medical, Inc. (the “Company”), has made the
following unregistered sales of equity securities:
On
August
27, 2006, the Company issued a warrant to purchase 100,000 shares of the
Company’s common stock, par value $0.001 per share (the “Common Stock”) at $.08
per share to a consultant as payment pursuant to an advisory agreement. The
warrant vests as to 20,000 shares per month, and expires July 30,
2009.
On
August
27, 2006, the Company issued a warrant to purchase 1,625,000 shares of Common
Stock at $.08 per share to a consultant as payment pursuant to an advisory
agreement.
On
August
27, 2006, the Company issued a warrant to purchase 75,000 shares of Common
Stock
at $.08 per share to a consultant for services rendered.
On
August
27, 2006, the Company issued a warrant to purchase 275,000 shares of Common
Stock at $.08 per share to a consultant for services rendered.
On
August
27, 2006, the Company issued 416,666 shares of Common Stock to BlausenLisi,
L.P.
as partial payment for services rendered.
On
August
28, 2006, the Company issued to two investors an aggregate of 568,180 shares
of
Common Stock for conversion of an aggregate amount of $25,000 of convertible
promissory notes. The Company also issued, in connection with such conversions,
an aggregate of 113,636 shares of Common Stock to such investors. The Company
also issued warrants to purchase up to, in the aggregate, 416,666 shares
of
Common Stock, at $.08 per share and reduced the exercise price of warrants
to
purchase an aggregate of 416,666 shares of Common Stock from $.12 to $.08
per
share.
On
August
30, 2006, the Company sold an aggregate of 27,172,709 shares of its Common
Stock
at a price of $0.044 per share, and sold warrants to purchase an aggregate
of
13,586,342 shares of Common Stock at an exercise price of $0.08 per share,
for a
total aggregate purchase price of $1,195,600.
All
issuances of Common Stock and warrants described in this current report on
Form
8-K were made by the Company prior to the effectiveness of a one-for-10 reverse
stock split of the Common Stock, effective August 31, 2006.
The
Company believes that none of the above transactions involved a public offering,
and the Company believes that each transaction was exempt from the registration
requirements of the Securities Act of 1933, as amended, by virtue of Rule
506 of
Regulation D and/or Section 4(2) of the Securities Act. The securities granted
in these transactions are restricted and may not be resold unless they are
subsequently registered under the Securities Act or resold pursuant to an
applicable exemption therefrom.
Item
7.01. Regulation
FD Disclosure.
The
Company is furnishing presentation materials, included as Exhibit 99.1 to this
current report and incorporated into this item by reference, which presentation
is to be used by the Company to present at future meetings with potential
investors.
Item
8.01. Other
Events.
On
September 6, 2006, the Company issued a press release announcing the Company’s
completion of a private financing of $1,750,000. A copy of the press release
announcing the financing is attached as Exhibit 99.2.
Item
9.01. Financial
Statements and Exhibits.
(d)
Exhibits.
Exhibit
99.1 Presentation
to Investors
Exhibit
99.2 Press
Release dated September 6, 2006
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.
| PHASE III MEDICAL, INC. | ||
|
By:
|
/s/ Robin L. Smith | |
| Robin L. Smith | ||
| Chief Executive Officer | ||
Dated:
September 6, 2006
Exhibit
99.1
 neostem
Your Cells your use www.neostem.com
|
NeoStem A subsidiary of Phase III Medical, Inc. |
 |
FORWARD LOOKING STATEMENT S 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 CONFIDENTIAL PRESENTATION, STATEMENTS THAT ARE NOT STATEMENTS OF CURRENT OR HISTORICAL FACT MAY BE DEEMED TO BE FORWARDLOOKING 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 THOSE SET FORTH IN THE COMPANY"S SEC FILINGS. RECIPIENTS OF THIS PRESENTATION ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE HEREOF. |
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Medical researchers, scientists, institutions, physicians, pharmaceutical companies, and biotechnology companies are racing to develop treatments of many diseases using stem cells |
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NeoStem is the first company that specializes in thecollection, processing, and long-term storage of adult stemcells for autologous use (Your cells for Your use) Two patent applications filed on collection and storage process Multiple use Unique biobank being developed |
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Disease Treatable with Stem Cells TODAY o Leukemias o Lymphoma o Multiple Myeloma o Radiation Sickness o Autoimmune Dx o Tissue Repair & Burns o Breast & Ovarian Cancer FUTURE POSSIBILITIES o Diabetes o Cardiovascular Dx o Spinal Cord Injuries o Skin Rejuvenation o Rheumatologic o Orthopaedic oStroke |
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Stem Cell Origination o Controversial o Embryo o Fetal Tissue o Non-Controversial o Umbilical Cord Blood o Bone Marrow o Adult Peripheral Blood (NeoStem) |
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Who should bank their stem cells? o Health conscious individuals o Individuals with family histories of heart disease, diabetes or cancer o Individuals diagnosed with cancer o Individuals that are exposed to radiation or harmful toxins because of their jobs o "First Responders," who may be exposed to lethal levels of radiation (firemen, policemen, military personnel andhomeland security personnel, etc.) |
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Stem Cells and Pluripotency Stem Cell -PRIMITIVE AND THUS UNSPECIALIZED IVEAN S UN ALI -SELF-RENEWING -CAN DIFFERENTIATE INTO CELLS -CAN FF AT N ES WITH SPECIFIC FUNCTIONS SPE I IONS EctodermEctoderm Skin Hair Brain Nerves Etc. SkinHairBrainNervesEtc. Mesoderm Mesoderm Endoderm Endoderm Cardiac Skeletal Renal Muscle Blood Etc. Cardiac Skeletal Renal Muscle Blood Etc. Lung Gut Thyroid Pancreas Etc. LungGutThyroidPancreasEtc. |
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Autologous vs. Allogeneic Stem Cells Autologous Allogeneic Tissue Matching Not Required Required Rejection No Yes Graft v. Host No Yes Engraftment Faster Slower Immune Recon. Faster Slower HIV, Hepatitis etc. from Donor None Possible |
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Appeal to Insurance Companies -$avings Autologous Allogeneic Hospitalization Short (<5 days) Long (>30 days) Time to Tx 1-2 days 90 days (avg.) Cost of Cells ~$6,000 >$22,000 Total Cost of Tx ~$50,000 $300 -$500 K Minority Avail. With Storage Very Low Match Avail. Not Applicable <50% Post -Tx Drugs None ~$4,000/ yr. |
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Intellectual Property o NeoStem has two pending U.S. patent applications describing key aspects of our process. Theseapplications are: - Elective Collection and Banking of Autologous Peripheral Blood Stem Cells. Publication Number 20040258673, Application Number 10/819,342, Priority Date April 2003 o This pending patent application addresses the process by which NeoStem prepares and stores stem cells collected from the peripheral blood by an apheresis process o Our methodology to separate primary stem cells and store them innumerous aliquots in order to be used for individual disease-related therapies o 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 inmultiple doses of stem cells |
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Intellectual Property (Cont.) - System Capable of Treating and Defining Various Disease States Using Stem Cells. Publication Number 20040265281, Application Number 10/819,398 Priority Date April 2003 o 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 o The establishment of a broad bank of stem cells will allow the Company to capitalize on the information contained within these cells that can be sold to pharmaceutical companies to in connection with pre-clinical research and discovery o Each client is asked to donate a small number of cells to this data bank There can be no assumption that either of these pending U.S. patent applications will ultimately issue as patents |
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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 Cell for autologous use critical to First Responders, Military, etc. |
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Hernigou P et al. J Bone & Joint Surg 87A: 1430, 2005 FractureFractureN o n u n i o n No n u n i o n 1 m p o s t B M S C 1 mpo s t BMSC2 m p o s t B M S C 2 mpo s t BMSC3 m p o s t B M S C 3 mpo s t BMSCPercutaneous Autologous Bone Marrow Grafting for Nonunions |
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Chronic Heart Disease o 5 million people in U.S. have chronic heart disease - 550K new diagnoses each year o Until now no effective therapy o Adult stem cells are being used to repair heart muscle o American Heart Association ranks restoration of failing hearts by adult stem cells among top 10 lifesaving advances of 2004 |
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A. Direct intramyocardial through the epicardium B. Direct intramyocardial via the endocardium C. Intracoronary D. Retroperfusion via the cardiac veins A.Direct intramyocardial through the epicardiumB.Direct intramyocardial via the endocardiumC.IntracoronaryD.Retroperfusion via the cardiac veins A B C D CATHETER From: Mathur, A and Martin, JF Lancet 364: 183, 2004 Potential Routes of Direct Delivery of Stem cells to Heart |
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University
of Pittsburgh School of Medicine • 20 patients w/ severe chronic heart
disease - NY Heart Assoc Classification III & IV - 35% ejection
fraction (55% normal adult) • 10 patients received by-pass surgery &
adult stem cells during surgery • 10 patients received by-pass surgery
only • At six month follow-up average ejection fractions were: - 46.1 %
adult stem cell therapy (83% of normal) - patients cured - 37.2 %
w/o
adult stem cell therapy (67% of normal) - patients continue to suffer
from
severe chronic heart disease
|
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Texas Heart Institute o Post-AMI Trial o 14 patients with an average age of 56 received the stem cell therapy o 7 patients served as a control group o At 4 months, the treated patients had a sustained improvement in pumping power and ability to supplyblood to the body o FDA Approved Trial in US March 2004 |
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From: Evangelos V. Badiavas and Vincent Falanga Arch.Dermatol. 139:510, 2003 |
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Comp Table Capital Raised in 2005 Net 52 last 12 2005 Income/ Current Week 52 Week Market Shares Months Revenues (Loss) Company Smbl Price Hi Low Cap (Mil) O/S (Mil) (Mil) (000) (000) Celgene Corp CELG $42.5 $49.4 $22.6 $14,903.0 350.7 $30.0 $536,941.0 $63,660.0 Geron Corp GERN $7.0 $12.2 $6.0 $463.1 66.2 $4.0 $6,158.0 ($33,528.0) BioStem, Inc. BTEM $2.7 $7.0 $0.3 $464.3 175.2 $0.0 $1,085.1 ($940.0) ViaCell Inc VIAC $4.0 $7.1 $3.6 $154.5 38.6 $0.0 $44,443.0 ($14,667.0) StemCells Inc STEM $2.3 $6.2 $1.8 $179.7 77.7 $35.8 $205.9 ($11,738.0) Aastrom BioScience ASTM $1.2 $2.9 $1.1 $142.0 119.3 $25.5 $909.0 ($11,811.0) Cytori Therapeutics CYTX $5.0 $9.6 $4.1 $87.7 17.5 $16.8 $6,005.0 ($26,538.0) CryoCell, Inc CCEL $2.6 $4.0 $2.1 $30.1 11.6 $0.0 $14,450.3 $1,033.0 Cord Blood America CBAI $0.1 $0.4 $0.1 $4.1 40.5 $5.0 $2,277.5 ($6,126.1) |
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Management/Directors/Staff o Robin Smith, M.D., MBA, NeoStem Chairman of the Board and CEO, Chairman Advisory Board of China Biopharmaceuticals (OTC BB: CHBP), Chairman of NYU-Hospital for Joint Diseases o Mark Weinreb, NeoStem Director and President, Former Owner, Bio Health Laboratories o Larry A. May, NeoStem Chief Financial Officer, Former Treasurer, Amgen (NASDAQ: AMGN) o 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 o 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 o George Smith, M.D., NeoStem Medical Director Laboratory Operations in California. Among his many distinguished career accomplishments, Dr Smith is cofounder of UCLA Bone Marrow Transplant Center o Catherine M. Vaczy, NeoStem VP & General Counsel, Former VP and Associate General Counsel, ImClone (NASDAQ: IMCL) o Joseph Zuckerman, M.D., NeoStem Director, Chairman of NYU-Hospital for Joint Diseases, Department of Orthopaedic Surgery |
Contact
Information NeoStem, Inc. 420 Lexington Avenue Suite 450 New York, NY 10170
Main
Phone: (212) 584-4180 Fax: (646) 514-7787 Web Site: www.neostem.com
EXHIBIT
99.2
| CONTACTS | ||
| Robin Smith | Stanley Wunderlich/Daniel Stepanek | |
| CEO, NeoStem, Inc. | Consulting for Strategic Growth 1 | |
| 420 Lexington Ave, Suite 450 | 800 Second Avenue | |
| NYC, NY 10170 | New York, NY 10017 | |
| Tel: (212) 581-5150 | Tel: (800) 625-2236/ (212) 896-1206 | |
| Fax: (646) 514-7787 | Fax: (212) 337-8089 | |
| E-mail: rsmith@neostem.com | Emails: info@cfsg1.com | |
| Web site: www.neostem.com |
|
dstepanek@cfsg1.com |
| Web site: www.cfsg1.com | ||
FOR
IMMEDIATE
RELEASE
NEOSTEM,
INC. COMPLETES FINANCING OF $1.75 MILLION
NEW
YORK, September 6, 2006 -NeoStem, Inc. (OTCBB:NEOI),
a
company pioneering autologous Adult Stem Cell (ASC) collection and banking
service for the general population for long-term storage for multiple
therapeutic uses, today announced
it
has completed a private financing in the amount of $1,750,000.
This
is
the second important financing the Company has completed in less than three
months. On June 12, 2006, the Company, then operating as Phase III Medical,
Inc.
(OTCBB:PHSM), announced a financing in the amount of $2,079,000, with DC
Associates, LLC acting as the principal investor.
On
August
30, 2006, following shareholders’ approval of a corporate name change from Phase
III Medical, Inc. to NeoStem, Inc., the Company entered into a Securities
Purchase Agreement with a group of sophisticated individual accredited
investors, including Richard Berman, former CEO and Chairman of ICCA and
currently CEO of NexMed, Inc.; Michael Gardner, founder, President and CEO,
Baytree Capital; and Dan Wassong former Chairman, President and CEO of Del
Laboratories. Additionally, 80% of the note holders from the Convertible
Promissory Note representing $400,000 issued by the Company at the end of
December 2005 and January 2006 elected to extend or convert into common shares
of stock.
The
money
raised will be used to further develop the Company’s intellectual property -
including its proprietary methodology for processing and long-term storage
of
peripheral blood stem cells - operations, marketing and to build partnerships
with medical institutions, physicians and pharmaceutical companies. The Company
has moved its corporate office from Melville, Long Island to New York City
to be
closer to the financial community and academic institutions.
The
shareholders at the Company’s Annual Meeting held on August 29, 2006 approved
the change of the Company’s name to NeoStem, Inc. and approved a reverse split
of the Company’s Common Stock at a ratio of one-for-ten shares. The name change
and reverse stock split became effective on August 31, 2006 and the stock
has
begun to trade under its new trading symbol: OTCBB:NEOI. For more information,
please visit the Company’s Web site: www.neostem.com
Robin
L.
Smith, MD, MBA, Chairman and CEO of NeoStem, said, “We are extremely pleased
with the support we have received from our investors. we value and appreciate
their knowledge about the opportunities available for NeoStem in addressing
the
rapidly advancing applications of adult stem cells in potentially treating
disease and other critical health problems. NeoStem’s proprietary methodologies
allow adults to have their stem cells safely collected and conveniently banked
for future personal use. We believe investors know the importance of emerging
developments in these fields and recognize the key role of NeoStem’s services in
enabling clients to access their stem cells when needed.”
About
NeoStem, Inc.
NeoStem,
Inc. (OTCBB:NEOI), formerly Phase III Medical, Inc. (OTCBB:PHSM), is an
innovative, publicly traded company positioned to become a leader in the
adult
stem cell field and to capitalize on the increasing importance adult stem
cells
are expected to play in the future of regenerative medicine.
Using
its
proprietary process, NeoStem provides the infrastructure, methods and systems
that allow adults to have their stem cells safely collected and conveniently
banked for future therapeutic use, as needed, in the treatment of such
life-threatening diseases as diabetes, heart disease and radiation sickness
that
may result from a bio-terrorist attack. Adult stem cell therapy has also
been
used for many years in treating blood cancer. Further potential uses include
regenerative therapies for wound healing, autoimmune diseases such as multiple
sclerosis and lupus, and age-related degenerative musculoskeletal diseases
.
NeoStem
uses the least invasive form of collection called apheresis, a well known
safe
procedure that extracts stem cells from an adult’s peripheral blood. Once
collected, NeoStem’s storage process allows the cells to be cryo-preserved
during an individual’s lifetime for use when needed. The management, Board of
Directors and Advisors of NeoStem collectively have significant technical,
medical and scientific expertise as well as substantial experience in life
science marketing and business development.
######
Certain
statements in this press release constitute “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995, including
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 NeoStem’s business. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors, which may
cause the actual results, performance or achievements of the Company, or
industry results, to be materially different from any future results,
performance, or achievements expressed or implied by such 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; (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.”
Pursuant
to a July 1, 2006 agreement, Consulting For Strategic Growth I, Ltd. ("CFSG1")
provides the Company with consulting, business advisory, investor relations,
public relations and corporate development services, for which CFSG1 receives
a
fixed monthly fee for the duration of the agreement. Independent of CFSG1's
receipt of cash or other compensation from the Company, CFSG1 may choose
to
purchase the common stock of the Company and thereafter sell those shares
at any
time it deems appropriate to do so. For more information, please visit
www.cfsg1.com