Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
_______________
FORM
10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
FOR THE
QUARTERLY PERIOD ENDED MARCH 31, 2009
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
Transition Period from __________________ to
_________________________
Commission
File Number 0-10909
NEOSTEM,
INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
22-2343568
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
|
|
420
LEXINGTON AVE, SUITE 450 NEW YORK, NEW
YORK
|
10170
|
(Address
of principal executive offices)
|
(zip
code)
|
Registrant’s
telephone number, including area code: 212-584-4180
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes o No
o
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large accelerated filer
o
|
Accelerated filer o
|
|
|
Non-accelerated
filer o (Do
not check if a smaller reporting company)
|
Smaller reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No x
7,949,476 SHARES,
$.001 PAR VALUE, AS OF MAY 13, 2009
(Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date)
I
N D E X
|
|
Page No.
|
Part
I - Financial Information:
|
|
|
|
|
Item
1.
|
Consolidated
Financial Statements (Unaudited):
|
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
At
March 31, 2009 and December 31, 2008
|
3
|
|
|
|
|
Consolidated
Statements of Operations
|
|
|
for
the three months
|
|
|
ended
March 31, 2009 and 2008
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
|
|
for
the three months ended March 31, 2009 and 2008
|
5
|
|
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6-14
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
15-19
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About
|
19
|
|
Market
Risk
|
|
|
|
|
Item
4T.
|
Controls
and Procedures
|
19
|
|
|
|
Part
II - Other Information:
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
20
|
|
|
|
Item
1A.
|
Risk
Factors
|
20
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
|
|
|
Proceeds
|
20
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
21
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Securityholders
|
21
|
|
|
|
Item
5.
|
Other
Information
|
21
|
|
|
|
Item
6.
|
Exhibits
|
21
|
|
|
|
|
Signatures
|
22
|
PART
I. FINANCIAL INFORMATION
Item
1. Consolidated Financial Statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
ASSETS
|
|
March
31,
2009
|
|
|
December
31,
2008
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
392,791 |
|
|
$ |
430,786 |
|
Accounts
receivable
|
|
|
12,109 |
|
|
|
7,193 |
|
Prepaid
expenses and other current assets
|
|
|
136,274 |
|
|
|
92,444 |
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
541,174 |
|
|
|
530,423 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
84,428 |
|
|
|
99,490 |
|
Goodwill
|
|
|
558,169 |
|
|
|
558,169 |
|
Intangible
Asset
|
|
|
624,986 |
|
|
|
633,789 |
|
Other
assets
|
|
|
2,112 |
|
|
|
2,445 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,810,869 |
|
|
$ |
1,824,316 |
|
LIABILITIES
AND STOCKHOLDERS’ (DEFICIT)/EQUITY
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
742,580 |
|
|
$ |
508,798 |
|
Accrued
liabilities
|
|
|
612,759 |
|
|
|
427,767 |
|
Note
payable, due related party
|
|
|
1,150,000 |
|
|
|
- |
|
Notes
payable
|
|
|
77,880 |
|
|
|
- |
|
Unearned
revenues
|
|
|
24,527 |
|
|
|
9,849 |
|
Capitalized
lease obligations – current portion
|
|
|
7,546 |
|
|
|
14,726 |
|
Total
current liabilities
|
|
|
2,615,292 |
|
|
|
961,140 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
|
2,615,292 |
|
|
|
961,140 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
(Deficit)/Equity:
|
|
|
|
|
|
|
|
|
Preferred
stock; authorized, 5,000,000 shares
|
|
|
|
|
|
|
|
|
Series
B convertible redeemable preferred stock,
|
|
|
|
|
|
|
|
|
liquidation
value 10 shares of common stock per
share;
$0.01 par value; authorized, 825,000 shares;
issued
and outstanding, 10,000 shares
|
|
|
100 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
Common
stock, $.001 par value; authorized,
|
|
|
|
|
|
|
|
|
500,000,000
shares; issued and outstanding,
|
|
|
|
|
|
|
|
|
7,917,406
March 31, 2009 and
|
|
|
|
|
|
|
|
|
7,715,006
December 31, 2008
|
|
|
7,917 |
|
|
|
7,715 |
|
Additional
paid-in capital
|
|
|
41,049,112 |
|
|
|
40,849,670 |
|
Accumulated
deficit
|
|
|
(41,861,552 |
) |
|
|
(39,994,309 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders’ (deficit) equity
|
|
|
(804,423 |
) |
|
|
863,176 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,810,869 |
|
|
$ |
1,824,316 |
|
See
accompanying notes to consolidated financial statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended March 31,
|
|
|
|
2009
|
|
|
2008
|
|
Earned
revenues
|
|
$ |
45,138 |
|
|
$ |
693 |
|
Direct
costs
|
|
|
23,550 |
|
|
|
- |
|
Gross
profit
|
|
|
21,588 |
|
|
|
693 |
|
Selling,
general and administrative
|
|
|
1,878,536 |
|
|
|
2,524,331 |
|
Operating
loss
|
|
|
(1,856,948 |
) |
|
|
(2,523,638 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
304 |
|
|
|
- |
|
Interest
expense
|
|
|
(10,599 |
) |
|
|
(3,551 |
) |
Net
loss
|
|
$ |
(1,867,243 |
) |
|
$ |
(2,527,199 |
) |
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
|
|
|
|
|
|
Net
loss per share
|
|
$ |
(.24 |
) |
|
$ |
(.52 |
) |
Weighted
average
|
|
|
|
|
|
|
|
|
shares
outstanding
|
|
|
7,802,894 |
|
|
|
4,904,542 |
|
See
accompanying notes to consolidated financial statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Three Months Ended March
31,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,867,243 |
) |
|
$ |
(2,527,189 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net
loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
shares issued and stock options granted for services
rendered
|
|
|
199,643 |
|
|
|
1,325,289 |
|
Depreciation
and amortization
|
|
|
29,893 |
|
|
|
16,225 |
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(4,916 |
) |
|
|
(2,262 |
) |
Prepaid
expenses and other current assets
|
|
|
(43,830 |
) |
|
|
(86,582 |
) |
Unearned
revenues
|
|
|
14,678 |
|
|
|
(693 |
) |
Accounts
payable, accrued expenses, and other current liabilities
|
|
|
418,777 |
|
|
|
(126,527 |
) |
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(1,252,999 |
) |
|
|
(1,401,739 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Acquisition
of equipment
|
|
|
(5,695 |
) |
|
|
(2,379 |
) |
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(5,695 |
) |
|
|
(2,379 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from advances on notes payable
|
|
|
1,283,720 |
|
|
|
126,993 |
|
Payments
of capitalized lease obligations
|
|
|
(7,180 |
) |
|
|
(5,886 |
) |
Repayments
of notes payable
|
|
|
(55,841 |
) |
|
|
(51,440 |
) |
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
1,220,699 |
|
|
|
69,667 |
|
|
|
|
|
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
|
(37,995 |
) |
|
|
(1,334,451 |
) |
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of period
|
|
|
430,786 |
|
|
|
2,304,227 |
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
$ |
392,791 |
|
|
$ |
969,776 |
|
|
|
Three Months Ended March
31,
|
|
|
|
2009
|
|
|
2008
|
|
Supplemental Disclosure
of Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period
for:
|
|
|
|
|
|
|
Interest
|
|
$ |
10,599 |
|
|
$ |
3,167 |
|
Supplemental Schedule of Non-cash
Financing Activities:
|
|
|
|
|
|
|
|
|
Issuance of restricted common
stock for services
|
|
$ |
104,850 |
|
|
$ |
72,800 |
|
Issuance of common stock for
services rendered
|
|
$ |
51,079 |
|
|
$ |
264,352 |
|
Issuance of common stock for
compensation
|
|
$ |
- |
|
|
$ |
66,515 |
|
Issuance of warrants for
services
|
|
$ |
42,918 |
|
|
$ |
23,808 |
|
Issuance of common stock for
payment of debt
|
|
$ |
- |
|
|
$ |
5,646 |
|
Compensatory element of stock
options
|
|
$ |
59,770 |
|
|
$ |
645,421 |
|
Vesting of restricted common stock
during period
|
|
$ |
45,876 |
|
|
$ |
319,547 |
|
See
accompanying notes to consolidated financial statements.
NEOSTEM,
INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NeoStem,
Inc. (“NeoStem” or the “Company”) was incorporated under the
laws of the State of Delaware in September 1980 under the name Fidelity
Medical Services, Inc. Our corporate headquarters is located at 420
Lexington Avenue, Suite 450, New York, NY 10170, our telephone number is
(212) 584-4180 and our website address is www.neostem.com.
|
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors which can then be accessed for their own future medical
treatment. We are managing a network of adult stem cell collection centers
in major metropolitan areas of the United States. We have also
entered the research and development arenas, through the acquisition of a
worldwide exclusive license to an early-stage technology to identify and isolate
rare stem cells from adult human bone marrow, called VSEL (very small
embryonic-like) stem cells. VSELs have many physical characteristics typically
found in embryonic stem cells, including the ability to differentiate into
specialized cells found in substantially all the different types of cells and
tissue that make up the body. On January 19, 2006, we consummated the
acquisition of the assets of NS California, Inc., a California corporation (“NS
California”) relating to NS California’s business of collecting and storing
adult stem cells. Effective with the acquisition, the business of NS
California became our principal business, rather than our historic business of
providing capital and business guidance to companies in the healthcare and life
science industries. The Company provides adult stem cell processing,
collection and banking services with the goal of making stem cell collection and
storage widely available, so that the general population will have the
opportunity to store their own stem cells for future healthcare needs. The
Company is also pursuing other technologies to advance its position in the field
of stem cell tissue regeneration.
On
August 9, 2007, the Company’s Common Stock commenced trading on the American
Stock Exchange (now NYSE Amex) under the symbol “NBS.”
Note 2 - Summary of
Significant Accounting Policies
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America for interim financial information and with the instructions for Form
10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by accounting principles generally
accepted in the United States of America for complete financial statements. In
the opinion of management, the statements contain all adjustments (consisting
only of normal recurring accruals) necessary to present fairly the financial
position as of March 31, 2009 and December 31, 2008, the results of operations
for the three months ended March 31, 2009 and 2008 and the cash flows for the
three months ended March 31, 2009 and 2008. The results of operations
for the three months ended March 31, 2009 are not necessarily indicative of the
results to be expected for the full year.
The
December 31, 2008 consolidated balance sheet has been derived from the audited
consolidated financial statements at that date included in the Company's Annual
Report on Form 10-K. These unaudited consolidated financial statements should be
read in conjunction with the consolidated financial statements and notes thereto
included in the Company's Annual Report on Form 10-K.
Principles of Consolidation:
The consolidated financial statements include the accounts of NeoStem, Inc. (a
Delaware corporation) and its wholly-owned subsidiaries, NeoStem Therapies, Inc.
and Stem Cell Technologies, Inc. All intercompany transactions and balances have
been eliminated.
Use of Estimates: The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts and disclosures.
Accordingly, actual results could differ from those estimates.
Cash Equivalents: Short-term
cash investments, which have a maturity of ninety days or less when purchased,
are considered cash equivalents in the consolidated statement of cash
flows.
Concentrations of
Credit-Risk: Financial instruments that potentially subject the Company
to significant concentrations of credit risk consist principally of cash. The
Company places its cash accounts with high credit quality financial
institutions, which at times may be in excess of the FDIC insurance
limit.
Allowance for Doubtful Accounts:
The Company establishes an allowance for doubtful accounts to provide for
accounts receivable that may not be collectible. In establishing the allowance
for doubtful accounts, the Company analyzes the collectability of individual
large or past due accounts customer-by-customer and establishes reserves for
accounts that it determines to be doubtful of collection. There was no allowance
for doubtful accounts necessary at March 31, 2009 and December 31,
2008.
Property and Equipment: The
cost of property and equipment is depreciated over the estimated useful lives of
the related assets of 3 to 5 years. The cost of computer software programs are
amortized over their estimated useful lives of five years. Depreciation is
computed on the straight-line method. Repairs and maintenance expenditures that
do not extend original asset lives are charged to expense as
incurred.
Income Taxes: The Company, in
accordance with SFAS 109, “Accounting for Income Taxes,” recognizes (a) the
amount of taxes payable or refundable for the current year and (b) deferred tax
liabilities and assets for the future tax consequences of events that have been
recognized in an enterprise’s financial statement or tax returns.
Comprehensive Income (Loss):
Refers to revenue, expenses, gains and losses that under generally
accepted accounting principles are included in comprehensive income but are
excluded from net income as these amounts are recorded directly as an adjustment
to stockholders’ equity. At March 31, 2009 and December 31, 2008
there were no such adjustments required.
Goodwill: Goodwill represents
the excess of the purchase price over the fair value of the net assets acquired
in a business combination. The Company reviews recorded goodwill for potential
impairment annually or upon the occurrence of an impairment indicator. The
Company performed its annual impairment tests as of December 31, 2008 and
determined no impairment exists. The Company will perform its future annual
impairment as of the end of each fiscal year.
Intangible Asset: SFAS No.
142 requires purchased intangible assets other than goodwill to be amortized
over their useful lives unless those lives are determined to be indefinite.
Purchased intangible assets are carried at cost less accumulated amortization.
Definite-lived intangible assets, which consists of patents and rights
associated with the Very Small Embryonic Like (“VSEL”) Stem Cells which
constitutes the principal assets acquired in the acquisition of Stem Cell
Technologies, Inc., have been assigned a useful life and are amortized on a
straight-line basis over a period of twenty years.
Impairment of Long-lived
Assets: We
review long-lived assets and certain identifiable intangibles to be held and
used for impairment on an annual basis and whenever events or changes in
circumstances indicate that the carrying amount of an asset exceeds the fair
value of the asset. If other events or changes in circumstances indicate that
the carrying amount of an asset that we expect to hold and use may not be
recoverable, we will estimate the undiscounted future cash flows expected to
result from the use of the asset or its eventual disposition, and recognize an
impairment loss. The impairment loss, if determined to be necessary, would be
measured as the amount by which the carrying amount of the assets exceeds the
fair value of the assets.
Accounting for Stock Based
Compensation: In December 2004, the FASB issued SFAS No. 123(R),
"Share-Based Payment" ("SFAS No. 123(R)"). SFAS No. 123(R) establishes standards
for the accounting for transactions in which an entity exchanges its equity
instruments for goods or services. This statement focuses primarily on
accounting for transactions in which an entity obtains employee services in
share-based payment transactions. SFAS No. 123(R) requires that the fair value
of such equity instruments be recognized as an expense in the historical
financial statements as services are performed. Prior to SFAS No. 123(R), only
certain pro forma disclosures of fair value were required. The Company has
adopted SFAS No. l23(R) effective January 1, 2006. The Company determines value
of stock options by the Black-Scholes option pricing model. The value of options
issued during 2008, 2007 and 2006 or that were unvested at January 1, 2006 are
being recognized as an operating expense ratably on a monthly basis over the
vesting period of each option. There were no options issued during the three
months ended March 31, 2009. With regard to stock options and warrants issued to
non-employees the Company has adopted EITF 96-18 “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring or in
Conjunction with Selling Goods and Services.”
Earnings Per Share: Basic
(loss)/earnings per share is based on the weighted effect of all common shares
issued and outstanding, and is calculated by dividing net (loss)/income
available to common stockholders by the weighted average shares outstanding
during the period. Diluted (loss)/earnings per share, which is calculated by
dividing net (loss)/income available to common stockholders by the weighted
average number of common shares used in the basic earnings per share calculation
plus the number of common shares that would be issued assuming conversion of all
potentially dilutive securities outstanding, is not presented as it is
anti-dilutive in all periods presented. For the three months ended March 31 2009
and 2008 the Company incurred net losses and therefore no common stock
equivalents were utilized in the calculation of earnings per share. At March 31,
2009 and 2008 the company had common stock equivalents outstanding as
follows:
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
Stock
Options
|
|
|
1,718,300 |
|
|
|
1,826,800 |
|
Warrants
|
|
|
5,305,692 |
|
|
|
2,107,688 |
|
Advertising Policy: All
expenditures for advertising are charged against operations as
incurred.
Revenue Recognition: The
Company initiated the collection and banking of autologous adult stem cells in
the fourth quarter of 2006. The Company recognizes revenue related to the
collection and cryopreservation of autologous adult stem cells when the
cryopreservation process is completed which is generally twenty four hours after
cells have been collected. Revenue related to advance payments of storage fees
is recognized ratably over the period covered by the advanced payments. The
Company also earns revenue, in the form of start up fees, from physicians
seeking to establish autologous adult stem cell collection centers. These fees
are in consideration of the Company establishing a service territory for the
physician. Start up fees are recognized once the agreement has been signed and
the physician has been qualified by the Company’s credentialing
committee.
Note 3 – Recent Accounting
Pronouncements
In April
2009, the FASB issued FSP FAS 141(R)- 1 “Accounting for Assets Acquired and
Liabilities Assumed in a Business Combination That Arise from
Contingencies”. This FSP amends the guidance in FASB Statement
No. 141(R) and is effective for the first annual reporting period beginning on
or after December 15, 2008. We are currently evaluating the
requirements of this pronouncement on our proposed merger with China
Biopharmaceuticals Holdings, Inc. but do not anticipate this will have an impact
on the merger or our financial position if the merger is approved by
shareholders.
In June 2008, FASB ratified EITF No. 07-5, "Determining Whether
an Instrument (or an Embedded Feature) Is Indexed to an Entity's Own Stock"
("EITF 07-5"). EITF 07-5
provides that an entity should use a two-step approach to evaluate whether an
equity-linked financial instrument (or embedded feature) is indexed to its own
stock, including evaluating the instrument's contingent exercise and settlement
provisions. EITF 07-5 is effective for financial statements issued for fiscal
years beginning after December 15, 2008. Early application is not
permitted. At the present
time we do not have any such equity instruments but we are assessing the potential impact of
this EITF on our future
financial condition and
results of operations.
Note 4 - Notes
Payable
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed Merger and Share Exchange
transactions, other initiatives in China as well as other ongoing obligations of
the Company, on February 25, 2009 and March 6, 2009, respectively, the Company
issued promissory notes to RimAsia Capital Partners,L.P. (“RimAsia”), a
principal stockholder of the Company, in the principal amounts of $400,000 and
$750,000, respectively. The notes bear interest at the rate of 10%
per annum and are due and payable on October 31, 2009, except that all principal
and accrued interest on the Notes shall be immediately due and payable in the
event the Company raises over $10 million in equity financing prior to October
31, 2009. The notes contain standard events of default and in the
event of a default that is not subsequently cured or waived, the interest rate
will increase to a rate of 15% per annum and, at the option of RimAsia and upon
notice, the entire unpaid principal balance together with all accrued interest
thereon will be immediately due and payable. The notes or any portion
thereof may be prepaid at any time and from time to time at the discretion of
the Company without premium or penalty. On April 9, 2009 these notes and the
related accrued interest were repaid from the proceeds of an $11 million
offering of units consisting of shares of the Company’s Series D Convertible
Redeemable Preferred Stock and warrants to purchase shares of Common Stock (See
Note 8 - Subsequent Events).
The
Company has financed certain insurance polices and has notes payable at March
31, 2009 in the amount of $77,880 related to these policies. These notes require
monthly payments and mature in less than one year.
Note 5 - Stockholders’
Equity
Common
Stock:
In
January 2009, the Company entered into an agreement with a physician who was
retained as a consultant. The term of this agreement is January 2009
through December 31, 2011. As part of the consideration for providing
services, the physician is to receive $24,000 annually, by the issuance of
shares of the Company’s Common Stock under the 2003 EPP in equal monthly
installments of $2,000 on the last day of each month during the term of the
agreement at a per share purchase price equal to the closing price of the Common
Stock on the last day of each month, which payment shall be made in cash in the
event shares under the 2003 EPP are unavailable. During the three
months ended March 31, 2009, 7,984 shares of Common Stock, with a value of
$6,000, were issued to the physician pursuant to this agreement.
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relation services to the Company since 2005, pursuant to
which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The stock issued to this consultant had a
value of $27,600 of which $16,560 was recognized as an operating expense in the
three months ended March 31, 2009 based on the vesting of the Common
Stock. The issuance of such securities is subject to the approval of
the NYSE Amex.
In
January 2009, the Company issued to its grant consultant, 20,000 shares of
restricted Common Stock, with a value of $13,800 as a bonus under the
consultant’s Consulting Agreement with the Company dated February 8, 2008, in
consideration for such consultant being instrumental in securing the Company’s
inclusion in the Department of Defense Fiscal Year 2009 Appropriations Bill in
the net amount of approximately $680,000. The issuance of such
securities was subject to the approval of the NYSE Amex, which approval was
obtained in January 2009. The Company has entered into a new
consulting agreement with such grant consultant for a one-year term commencing
as of January 1, 2009. In consideration for services, the consultant
will be issued shares of the Company’s restricted Common Stock equal to a value
of $60,000 based on the closing price of the Company’s Common Stock on the date
of execution of the agreement, which has been determined to be 67,416 shares, to
vest as to one-half of such shares on June 30, 2009 and the remaining one-half
of such shares on December 31, 2009. The issuance of such securities are
subject to the approval of the NYSE Amex. For the three months ended March 31,
2009 the Company has recognized $15,000 as an operating expense relating to
these shares.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock, with a value of $8,280, pursuant to the terms of a
three month consulting agreement entered into in October 2008, scheduled to vest
pursuant to the agreement as to 4,000 shares at the end of each 30 day period
during the term. The issuance of such securities was subject to the
approval of the NYSE Amex, which approval was obtained in January
2009.
In
January 2009, the Company issued to a member of its Scientific Advisory Board
20,000 shares of Common Stock under the 2003 EPP, with a value of $15,000, in
consideration of this individual’s contribution to a special project related to
the design of a cardiac stem cell clinical trial for end stage cardiomiopathy
anticipated to be conducted in the People’s Republic of China.
In
February 2009, the Company entered into a consulting agreement with a one year
term commencing March 1, 2009, with a physician to provide services to the
Company including providing medical expertise in the areas of apheresis and
laboratory medicine and to serve (as needed) as medical director for centers in
the Company’s stem cell collection center network as well as other related
activities, in partial consideration for which the physician is to receive a
one-time payment of 10,000 shares of Common Stock under the 2003 EPP, which
shares were issued as of February 2009. Such shares had a value of
$8,000.
In March
2009, the Company entered into an agreement with a consultant which has been
providing financial market related services to the Company since 2008, pursuant
to which this consultant was retained to provide additional financial market
related services for a three month period. In partial consideration
for providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, with a
value of $17,250, to vest as to one-third of the shares at the end of each
monthly period during the term. Based on these vesting terms, the Company has
recognized $5,750 as an operating expense in the three months ended March 31,
2009. This consultant was also issued a five year warrant to purchase
25,000 shares of restricted Common Stock at a per share exercise price of $1.00,
with a value of $16,867. (See Warrants below). The issuance of such
securities is subject to the approval of the NYSE Amex.
Warrants:
The
Company has issued common stock purchase warrants from time to time to investors
in private placements, certain vendors, underwriters, and directors and officers
of the Company. A total of 5,305,692 shares of common stock are reserved for
issuance upon exercise of outstanding warrants as of March 31, 2009 at prices
ranging from $.78 to $8.00 and expiring through March 2014.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of Common Stock at a purchase price of $1.40 per share,
with a value of $3,338. This warrant was issued in consideration of services
rendered after the expiration of an October 2007 consulting agreement with the
Company pursuant to which this consultant was engaged to create marketing
materials for our sales and marketing staff. The issuance of this warrant was
subject to the approval of the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant to provide
financial market related services for a three month period beginning March
2009. As partial consideration for providing services under this
agreement, the Company agreed to issue to the consultant a five year warrant to
purchase 25,000 shares of restricted Common Stock at a per share exercise price
of $1.00, with a value of $16,867, vesting in its entirety at the end of the
term; for the three months ended March 31, 2009 the Company recognized $5,622 as
an operating expense. The issuance of this warrant is subject to the
approval of the NYSE Amex.
In the Company’s August 2007 public
offering, units were issued comprised of shares of the Company’s Common Stock, and Class A warrants to purchase
an aggregate of 635,000 shares of Common Stock. The Company also
issued to its underwriter group warrants (the “Underwriter Warrants”) to
purchase an aggregate of 95,250 shares of Common Stock. The Class A
Warrants were issued pursuant to the terms of a Restated Warrant Agreement made
as of August 14, 2007 between the Company and the Class A Warrant
agent. The Underwriter Warrants were issued individually to each
member of the underwriting group. The Underwriter Warrants had
a higher exercise price ($6.50) than that of the Class A Warrants, and
unlike the Class A Warrants, could not be exercised for a period of one year
from the date of issuance and contained provisions for cashless exercise.
In September, 2008 the Company made the determination that certain of the
Underwriter Warrants totaling 86,865 shares of Common Stock, should be accounted
for as a derivative liability and reported on our balance sheet as such. Upon
the closing of our August 2007 public offering the fair value and thus the
derivative liability value of these certain Underwriter Warrants was $195,551.
At December 31, 2008 the derivative liability value associated with these
certain Underwriter Warrants was $0 and at March 31, 2009 the derivative
liability value of these Underwriter Warrants was $32,514 and has been reflected
as an accrued liability as of March 31, 2009.
At March 31, 2009, the outstanding
warrants by range of exercise prices are as follows:
|
|
|
|
|
Number
Outstanding
|
|
|
Weighted
Average
Remaining
|
|
|
Number
Exercisable
|
|
Exercise Price
|
|
|
March 31, 2009
|
|
|
Contractual Life (years)
|
|
|
March 31, 2009
|
|
$ |
0.78
to |
|
$ |
3.02 |
|
|
|
3,295,709 |
|
|
|
4.36 |
|
|
|
2,504,045 |
|
$ |
3.02
to |
|
$ |
5.27 |
|
|
|
184,250 |
|
|
|
2.91 |
|
|
|
184,250 |
|
$ |
5.27
to |
|
$ |
7.51 |
|
|
|
802,761 |
|
|
|
3.43 |
|
|
|
802,761 |
|
$ |
7.51
to |
|
$ |
8.00 |
|
|
|
1,022,972 |
|
|
|
3.36 |
|
|
|
1,022,972 |
|
|
|
|
|
|
|
|
|
5,305,692 |
|
|
|
|
|
|
|
4,514,028 |
|
Options:
The Company’s 2003 Equity Participation Plan (the “2003 EPP”) permits the grant of share options and
shares to its employees, directors, consultants and advisors for
up to 2,500,000
shares of Common Stock as stock
compensation. All stock options under the 2003 EPP are generally granted at the fair
market value of the Common Stock at the grant date. Employee stock
options vest ratably over a period determined at time of grant, or upon the accomplishment of
specified business milestones, and generally expire 10 years from the
grant date.
Effective January 1, 2006, the Company’s
2003 EPP is accounted for in accordance with the
recognition and measurement provisions of Statement of Financial Accounting
Standards ("FAS") No. 123 (revised 2004), Share-Based Payment ("FAS 123(R)"),
which replaces FAS No. 123, Accounting for Stock-Based Compensation, and
supersedes Accounting Principles Board Opinion ("APB") No. 25, Accounting for
Stock Issued to Employees, and related interpretations. FAS 123 (R) requires
compensation costs related to share-based payment transactions, including
employee stock options, to be recognized in the financial statements. In
addition, the Company adheres to the guidance set forth within Securities and
Exchange Commission ("SEC") Staff Accounting Bulletin ("SAB") No. 107, which
provides the Staff's views regarding the interaction between SFAS No. 123(R) and
certain SEC rules and regulations and provides interpretations with respect to
the valuation of share-based payments for public companies.
The Company's results included share-based compensation
expense of $59,770 and
$645,421 for the three months ended March 31, 2009 and 2008,
respectively. Such amounts
have been included in the consolidated statements of operations within general and administrative
expenses.
Stock option compensation expense is the
estimated fair value of options granted amortized on a straight-line basis over
the requisite service period for the entire portion of the award and those options that
vested upon the accomplishment of business milestones. Options vesting on the
accomplishment of business milestones will not be recognized for compensation
purposes until such milestones are accomplished. At March 31, 2009 there were
options to purchase 265,000 shares outstanding that will vest on the
accomplishment of certain business milestones.
The
weighted average estimated fair value of stock options granted in the three
months ended March 31, 2009 and 2008 were $0 and $1.48, respectively. The fair
value of options at the date of grant was estimated using the Black-Scholes
option pricing model. During the three months ended March 31, 2009 and the years
ended 2008, 2007 and 2006, the Company took into consideration the guidance
under SFAS 123(R) and SAB No. 107 when reviewing and updating assumptions. The
expected volatility is based upon historical volatility of our stock and other
contributing factors. The expected term is based upon observation of actual time
elapsed between date of grant and exercise of options for all
employees. Previously such assumptions were determined based on
historical data.
The range of assumptions made in calculating the fair
values of options are as follows:
|
|
|
|
|
|
Three
Months Ended March 31,
|
|
|
2009
|
|
2008
|
|
Expected
term (in years)
|
None
Issued
|
|
10
|
|
|
|
|
|
|
Expected
volatility
|
None
Issued
|
|
119%
to 121%
|
|
|
|
|
|
|
Expected
dividend yield
|
None
Issued
|
|
0%
|
|
|
|
|
|
|
Risk-free
interest rate
|
None
Issued
|
|
3.64%
to 3.85%
|
|
Stock
option activity under the 2003 Equity Participation Plan is as
follows:
|
|
Number of Shares
(1)
|
|
|
Range of Exercise
Price
|
|
|
Weighted Average Exercise
Price
|
|
|
Weighted Average Remaining
Contractual Term
|
|
|
Aggregate Intrinsic
Value
|
|
Balance December 31,
2008
|
|
|
1,725,300 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
3.96 |
|
|
|
|
|
|
|
Granted
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(2,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(5,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance March 31,
2009
|
|
|
1,718,300 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
3.96 |
|
|
|
7.78 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Exercisable at March
31, 2009
|
|
|
1,389,300 |
|
|
|
|
|
|
$ |
4.10 |
|
|
|
7.56 |
|
|
$ |
- |
|
(1)
|
-- All options are exercisable for
a period of ten years.
|
|
|
|
|
|
Number
Outstanding
|
|
|
Weighted
Average
Remaining
|
|
|
Number
Exercisable
|
|
Exercise Price
|
|
|
March 31, 2009
|
|
|
Contractual Life (years)
|
|
|
March 31, 2009
|
|
$ |
0.71 to |
|
$ |
4.17 |
|
|
|
827,000 |
|
|
|
8.82 |
|
|
|
663,000 |
|
$ |
4.17 to |
|
$ |
7.63 |
|
|
|
800,200 |
|
|
|
7.86 |
|
|
|
639,200 |
|
$ |
7.63 to |
|
$ |
11.08 |
|
|
|
50,000 |
|
|
|
6.70 |
|
|
|
46,000 |
|
$ |
11.08 to |
|
$ |
14.54 |
|
|
|
3,000 |
|
|
|
4.92 |
|
|
|
3,000 |
|
$ |
14.54 to |
|
$ |
25.00 |
|
|
|
38,100 |
|
|
|
6.27 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
1,718,300 |
|
|
|
|
|
|
|
1,389,300 |
|
Options
are usually granted at an exercise price at least equal to the fair value of the
Common Stock at the grant date and may be granted to employees, Directors,
consultants and advisors of the Company.
As of
March 31, 2009, there was approximately $1,086,300 of total unrecognized
compensation costs related to unvested stock option awards of which $92,500 of
unrecognized compensation expense is related to stock options that vest over a
weighted average life of .25 years. The balance of $993,800 of unrecognized
compensation costs is related to stock options that vest based on the
accomplishment of business milestones.
|
|
Options
|
|
|
Weighted Average Grant Date Fair
Value
|
|
Non-Vested at December 31,
2008
|
|
|
435,250 |
|
|
$ |
2.93 |
|
Issued
|
|
|
- |
|
|
|
|
|
Expired
|
|
|
(2,000 |
) |
|
|
|
|
Canceled
|
|
|
(5,000 |
) |
|
|
2.81 |
|
Vested
|
|
|
(99,250 |
) |
|
|
1.68 |
|
Exercised
|
|
|
- |
|
|
|
|
|
Non-Vested at March 31,
2009
|
|
|
329,000 |
|
|
$ |
3.35 |
|
The total
value of shares vested during the three months ended March 31, 2009 was $59,770.
Note 6 - Segment
Information
To date,
the Company’s operations have been conducted in only one geographical segment
and since March 31, 2007 the Company has realized revenue only from the banking
of adult autologous stem cells.
Note 7 - Related Party
Transactions
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed Merger and Share Exchange
transactions and other ongoing obligations of the Company, on February 25, 2009
and March 6, 2009, respectively, the Company issued promissory notes to RimAsia,
a principal stockholder of the Company in the principal amounts of $400,000 and
$750,000, respectively. The notes bear interest at the rate of 10%
per annum and are due and payable on October 31, 2009, except that all principal
and accrued interest on the notes shall be immediately due and payable in the
event the Company raises over $10 million in equity financing prior to October
31, 2009. The notes contain standard events of default and in the
event of a default that is not subsequently cured or waived, the interest rate
will increase to a rate of 15% per annum and, at the option of RimAsia and upon
notice, the entire unpaid principal balance together with all accrued interest
thereon will be immediately due and payable. The notes or any portion
thereof may be prepaid at any time and from time to time at the discretion of
the Company without premium or penalty. On April 9, 2009 these notes and the
related accrued interest were repaid from the proceeds of an $11 million
offering of preferred stock in which RimAsia purchased $5 million of Company
securities. (See Note 8 - Subsequent Events).
Note 8 - Subsequent
Events
On April
9, 2009, the Company completed a private placement financing totaling $11
million from three Asia-based investors. The financing consisted of
the issuance of 880,000 units priced at $12.50 per unit, with each unit
consisting of one share of the Company’s Series D Convertible Redeemable
Preferred Stock (“Series D Stock”) (convertible, subject to shareholder approval
as described below, into ten shares of Common Stock) and ten warrants with each
warrant to purchase one share of Common Stock.
Upon the
affirmative vote of holders of a majority of the voting power of the Company’s
Common Stock required pursuant to the Company’s Amended and Restated By-Laws and
the NYSE Amex, each share of Series D Stock will automatically be converted into
ten (10) shares of Common Stock at an initial conversion price of $1.25 per
share based on an original issue price of $12.50 per share; provided that if by
October 31, 2009 such affirmative vote is not achieved, the Company must redeem
all shares of Series D Stock at a redemption price per share of $12.50 plus the
accrued dividends as of such date. The Series D Stock has an accruing
dividend of ten percent (10%) per annum, payable (i) annually in cash on each
anniversary of the issue date, provided that the shares of Series D Stock remain
outstanding on such date or (ii) upon a liquidation, dissolution or winding up
of the Company. The Series D Stock (i) ranks senior to all of the
Company’s capital stock with respect to the payment of dividends and to the
distribution of assets upon liquidation, dissolution or winding up, (ii) does
not have any voting rights, (iii) does not have any anti-dilution protection,
and (iv) does not have any preemptive rights.
The warrants have a per share exercise price equal to
$2.50 and are callable by the Company if the Common Stock trades at a price
equal to a minimum of $3.50 for a specified period of time. Subject
to the affirmative vote of the Company’s shareholders and the rules of the NYSE
Amex, the warrants will become exercisable for a period of five years. The
securities sold were sold without registration under the Securities Act of 1933,
as amended (the " Securities Act") pursuant to Regulation S and Regulation D,
each promulgated under the Securities Act and may not be resold in the United
States or to U.S. persons unless registered under the Securities Act or pursuant
to an exemption from registration under the Securities Act.
The
investing firms were RimAsia Capital Partners, L,P, (“RimAsia”), a pan-Asia
private equity firm operating in partnership with a regional network of
strategic investors drawn from leading Asian families and companies, investing
$5 million for 400,000 units; Enhance Biomedical Holding Corporation based in
Shanghai, also investing $5 million for 400,000 units and Elancrest Investments
Ltd., a Singapore-based firm, investing $1 million for 80,000
units. RimAsia previously invested $1.25 million in NeoStem, as was
announced on September 3, 2008. The funds will be used to support the
development of NeoStem’s VSEL (very small embryonic-like stem cells) technology
licensed from the University of Louisville and help advance NeoStem’s expansion
activities in China, including those relating to recent licenses acquired, its
pending acquisitions and medical tourism – defined as travel to a foreign
country by people whose primary and explicit purpose is to receive advanced
medical therapies - relating to wounds, orthopedics and regenerative
medicine. NeoStem hopes to be a part of the growing medical tourism
industry through its connections with leading physicians in China and the U.S.
NeoStem plans to connect U.S. citizens with advanced therapies not yet available
in the U.S., and to attract people from other countries to seek safe and
effective regenerative therapies as they become available here. A portion of the
funds also will be used to expand U.S.-based operations including for general
corporate purposes. In addition, a portion of the proceeds were used to
repay $1,150,000 in bridge financing (see Note 4 - Notes
Payable) received from RimAsia in February and March
2009, plus $12,014 in interest on the bridge financing and other
costs recently advanced by RimAsia in connection with the Company’s expansion
activities in China totaling $472,559.09. The notes issued in the
bridge financing provided that all principal and accrued interest on the notes
would be immediately due and payable in the event the Company raised over $10
million in equity financing prior to October 31, 2009. As a result of
the private placement financing, such amounts became due and have been paid as
described above.
The
Company has entered into an agreement for the lease of executive office space
from SLG Graybar Sublease LLC (the “Landlord”) at Suite 450, 420 Lexington
Avenue, New York, with a lease term effective April 1, 2009 through June 30,
2013 (the “Lease”). Rental and utility payments are currently in the
aggregate approximate monthly amount of $20,100. To help defray the
cost of the Lease, the Company has licensed to third parties the right to occupy
certain of the offices in Suite 450 and use certain business
services. Such license payments currently total approximately $13,860
per month and the license agreements are for periods of one year or
less. The CEO of one such licensee, Promethean Corporation, is in an
exclusive relationship with the Company’s CEO. The Lease was entered into
pursuant to an assignment and assumption of the original lease from the original
lessor thereof, DCI Master LDC (the lead investor in a private placement by the
Company in June 2006) and affiliates of DCI Master LDC and Duncan Capital Group
LLC (a former financial advisor to and an investor in the Company), for which
original lease a principal of such entities acted as guarantor (the
“Guarantor”), a consent to such assignment from the Landlord and a lease
modification agreement between the Company and the Landlord, such documents
being dated April 13, 2009 with effective delivery April 17,
2009. The Company was credited with an amount remaining as a security
deposit with the Landlord from such original lessor (the “Security Deposit
Credit”), was required to deposit an additional amount with the Landlord to
replenish the original amount of security for the Lease and pay an amount equal
to the Security Deposit Credit to the Guarantor of the original
lease. The total payments made by the Company for such security
deposit and payment of the Security Deposit Credit to the Guarantor were in the
approximate aggregate amount of $157,100. Richard Berman, a director of the
Company, utilizes an office in Suite 450 in his capacity as Chairman of the
Company’s Audit, Compensation and Nominating Committees and for other business
purposes.
In order to advance our regenerative
medicine business abroad and expand our expertise into a new area, on April 13,
2009, the Company entered into a License Agreement (the “License
Agreement”) with Regenerative Sciences, LLC (“RSI”) with an effective
date of March 3, 2009 pursuant to which the Company acquired an exclusive,
royalty bearing, perpetual and irrevocable license, with the right to
sublicense, for the Asia territory, to use an innovative process that rapidly
grows a patient’s own adult stem cells to treat a variety of musculoskeletal
diseases. The licensed procedure has been developed by RSI, a
Colorado-based company focused on developing a medical procedure for the
treatment of chronic orthopedic conditions. The licensed intellectual
property consists of two issued patents, seven pending patent applications and
know-how and improvements relating thereto all as set forth in the License
Agreement. The License Agreement provides for a specified percentage
of royalties to be paid to RSI by the Company and certain diligence obligations
of the Company.
On May 1,
2009, the Company and RSI entered into a three year consulting agreement
effective March 3, 2009 whereby RSI will provide to the Company consulting
services in the area of stem cell therapy in orthopedics for the development of
business in Asia in return for which the Company has agreed to pay to the
consultant an annual cash fee, payable monthly, and certain stated equity over
the term of the agreement.
On April 23, 2009, the Company entered into
a License Agreement with Vincent Falanga, M.D., pursuant to which the Company
acquired a world-wide, exclusive, royalty bearing license, with the right
to sublicense, to certain innovative stem cell technology and
applications for wound healing. The term of the License Agreement
continues until the later of ten years from the first commercial sale or the
last to expire patent claim. The licensed intellectual property
consists of a pending patent application and know-how, copyrights and
trademarks, and improvements relating thereto. Dr. Falanga retained a
royalty-free license to use the licensed intellectual property for professional
use in his established medical practice and for doing medical research. The
License Agreement provides for a specified percentage of royalties to be paid to
Dr. Falanga by the Company and certain diligence obligations of the Company. The
license agreement also calls for certain annual payments commencing with the
execution of the agreement, creditable against royalties otherwise due and
payable under the agreement.
On April 30, 2009 the Company entered
into a License and Referral Agreement with Promethean Corporation (“Promethean”)
through its subsidiary Ceres Living, Inc. (“Ceres”) to use certain Company marks
and publications in connection with certain sales and marketing activities
relating to its nutritional supplement known as AIO Premium Cellular (the
“Product”); and in connection with the license, Ceres will pay to the Company or
the Stem for Life Foundation specified fees for each unit
of the Product sold; and Ceres shall engage in a referral service with respect
to the Company’s adult stem cell collection and storage activities. Ceres will receive a specified fee from
the Company for each client
referred who completes and
pays for a stem cell collection. The term of the agreement is three years with
each party having the right to renew annually, thereafter. The CEO of Promethean
is in an exclusive relationship with the CEO of the Company.
On April
9, 2009, the Company’s Board of Directors adopted and on May 8, 2009 the
Company’s stockholders approved, the 2009 Equity Compensation Plan (the “2009
Plan”). The general purpose of the 2009 Plan is to provide an incentive to our
employees, directors, consultants and advisors by enabling them to share in the
future growth of our business. The 2009 Plan will be administered by
the Compensation Committee of our Board of Directors. Pursuant to the
2009 Plan, the Compensation Committee may grant options to purchase shares of
our Common Stock, stock appreciation rights and restricted stock units payable
in shares of our Common Stock, as well as restricted or unrestricted shares of
our Common Stock. The aggregate number of shares of Common Stock
available for issuance in connection with options and awards granted under the
2009 Plan will be 3,800,000, subject to customary adjustments for stock splits,
stock dividends or similar transactions. The Company intends to file
with the Securities and Exchange Commission a Registration Statement on Form S-8
to register the shares of Common Stock underlying awards to be granted under the
2009 Plan. The 2009 Plan is subject to the approval of the NYSE
Amex.
As of May
8, 2009, the Compensation Committee of the Board of Directors approved, subject
to the filing of a Registration Statement on Form S-8 with the SEC to register
the issuance of the shares issuable under the Company’s 2009 Plan and the
approval of the NYSE Amex of the listing of the shares issuable under the
Company’s 2009 Plan, the making of certain awards under a Board of Directors
Compensation Plan. Accordingly, the Compensation Committee approved
the issuance to members of the Board acting in their capacity as Board members
and to the Board Secretary, options to be issued under the 2009 Plan to purchase
an aggregate of 575,000 shares of Common Stock. The options
will be exercisable at an exercise price equal to the fair market value of the
common stock on the date of grant and will be fully exercisable upon
grant. Additionally, Chairs of the Board and Board Committees were
authorized to be issued for each Chair they hold, either $25,000 or 25,000
shares of fully vested Common Stock. Accordingly, an aggregate of
$50,000 was paid and 50,000 shares of Common Stock will be awarded upon the
satisfaction of the foregoing described conditions. Additionally,
options to purchase an aggregate of 175,000 shares of Common Stock exercisable
at an exercise price equal to the fair market value of the Common Stock on the
date of grant, vesting as to 100,000 ratably over a two year period and as to
75,000 immediately upon grant were authorized to be issued to members of the
Company’s Scientific Advisory Board upon the satisfaction of the foregoing
described conditions.
On April 23, 2009, the Company entered into a three
year consulting
agreement pursuant to which a consultant is providing consulting services to the
Company in the area of business development, strategic planning and government
affairs in the healthcare industry in the People’s Republic of China (“PRC”),
engaging in such activities as requested by the Company from time to time
including, but not limited to the introduction to hospitals and medical
practices for the advancement of strategic relationships of the Company in
return for which the Company has agreed to pay to the consultant an annual cash
fee, payable monthly, and certain stated equity over the term of the
agreement.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
FORWARD
LOOKING STATEMENTS
General
This
Quarterly Report on Form 10-Q and the documents incorporated herein contain
"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 the Company, 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
Quarterly Report, statements that are not statements of current 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 statements. Additionally, statements concerning our ability to
successfully develop the adult stem cell business at home and abroad, 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 role of VSELs in
that future, and the potential revenue growth of such business are
forward-looking statements. Our future operating results are
dependent upon many factors, and the Company's further development is highly
dependent on future medical and research developments and market acceptance,
which is outside its control. Forward-looking statements may not be
realized due to a variety of factors, including, without limitation, (i) the
Company’s ability to manage the business despite continuing operating losses and
cash outflows; (ii) the Company’s ability to obtain sufficient capital or a
strategic business arrangement to fund its operations and expansion plans,
including meeting its financial obligations under various licensing and
other strategic arrangements and the successful commercialization of the
relevant technology; (iii) the Company’s ability to build the management and
human resources and infrastructure necessary to support the growth of the
business; (iv) competitive factors and developments beyond the
Company’s control; (v) scientific and medical developments beyond the
Company’s control; (vi) the Company’s inability to obtain appropriate
governmental licenses or any other adverse effect or limitations caused by
government regulation of the business; (vii) whether any of the Company’s
current or future patent applications result in issued patents and the Company’s
ability to obtain and maintain other rights to technology required or desirable
for the conduct of its business; (viii) whether any potential strategic benefits
of various licensing transactions will be realized and whether any potential
benefits from the acquisition of these new licensed technologies will be
realized; (ix) whether the Company can obtain the consents it may require to
sublicensing arrangements from technology licensors in connection with
technology development; (x) the Company’s ability to maintain its NYSE Amex
listing; and (xi) the other factors discussed in Item 1A, “Risk Factors”
contained in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2008 (the “Form 10-K”) and in other reports that we file with the
SEC.
Proposed
Merger; Share Exchange Agreement; Other China Initiatives
Additional
risks and uncertainties relate to (i) the Company’s proposed merger transaction
(“Merger”) pursuant to an Agreement and Plan of Merger with China
Biopharmaceuticals Holdings, Inc., a Delaware corporation ("CBH"), China
Biopharmaceuticals Corp., a British Virgin Islands corporation and wholly-owned
subsidiary of CBH, and CBH Acquisition LLC, a Delaware limited liability company
and wholly-owned subsidiary of NeoStem to acquire a 51% ownership interest in
Suzhou Erye Pharmaceuticals Company Ltd., a Sino-foreign joint venture with
limited liability organized under the laws of the People’s Republic of China;
(ii) the Company’s proposed share exchange transaction (“Share Exchange”)
pursuant to a Share Exchange Agreement to acquire through a series of
contractual arrangements certain benefits from Shandong New Medicine Research
Institute of Integrated Traditional and Western Medicine Limited Liability
Company, a China limited liability company; and (iii) the Company’s other
initiatives in China, that may cause actual future experience and results to
differ materially from those discussed in these forward-looking statements.
Important factors (i) related to the proposed Merger that might cause such a
difference include, but are not limited to, (a) costs related to the Merger; (b)
failure of the Company's or CBH’s stockholders to approve the Merger; (c) the
Company's or CBH's inability to satisfy the conditions of the Merger; (d) the
Company's inability to maintain its NYSE Amex listing; (e) the inability to
integrate the Company’s and CBH's businesses successfully and grow such merged
businesses as anticipated; (f) the need for outside financing to meet capital
requirements; (g) failure to have an effective Joint Venture Agreement
satisfactory to the parties and regulatory authorities; (ii) related to the
Share Exchange that might cause such a difference include, but are not limited
to, (a) costs related to the Share Exchange; (b) failure of the Company’s
stockholders to approve the Share Exchange; (c) an inability to satisfy the
conditions of the Share Exchange; (d) the Company's inability to maintain its
NYSE Amex listing; (e) the successful application of the variable interest
entity to a prohibited business in China; (f) the inability to integrate the
Company’s and Shandong's businesses successfully and grow such merged businesses
as anticipated; and (g) the need for outside financing to meet capital
requirements; (iii) related to the Company’s other initiatives in China that
might cause such a difference include, but are not limited to, (a) costs related
to funding these initiatives; (b) the successful application under Chinese law
of the variable interest entity structure to a prohibited business in China; (c)
the inability to integrate the Company and the business operations in China
successfully and grow such merged businesses as anticipated; and (d) the need
for outside financing to meet capital requirements; and (iv) related to each of
the Merger, the Share Exchange and the Company’s other initiatives in China,
respectively, the other events and factors disclosed in the Company’s Current
Reports on Form 8-K dated November 2, 2008 relating to the Merger and the Share
Exchange, and other risk factors discussed in Item 1A, “Risk Factors” contained
in the Company’s Form 10-K and in other periodic Company filings with the SEC
and to be disclosed in the Proxy Statement/Registration Statement on Form S-4
anticipated to be filed in connection with the Merger and the Share Exchange.
The Company’s filings with the Securities and Exchange Commission are available
for review at www.sec.gov under “Search for Company Filings.” Readers are
cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the Company
undertakes no obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
GENERAL
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors which can then be accessed for their own future medical
treatment. We are managing a network of adult stem cell collection centers
in major metropolitan areas of the United States. We have also entered the
research and development arenas, through the acquisition of a worldwide
exclusive license to an early-stage technology to identify and isolate rare stem
cells from adult human bone marrow, called VSEL (very small embryonic-like) stem
cells. VSELs have many physical characteristics typically found in embryonic
stem cells, including the ability to differentiate into specialized cells found
in substantially all the different types of cells and tissue that make up the
body. Additionally, we are pursuing other technologies to advance our position
in the field of stem cell tissue regeneration.
The adult
stem cell industry is a field independent of embryonic stem cell research which
NeoStem believes is more likely to be burdened by regulatory, legal, ethical and
technical issues than adult stem cell research. Embryonic stem cell research is
also burdened with the issues of tissue compatibility. Medical
researchers, scientists, medical institutions, physicians, pharmaceutical
companies and biotechnology companies are currently developing therapies for the
treatment of disease using adult stem cells. As these adult stem cell
therapies obtain necessary regulatory approvals and become standard of care,
patients will need a service to collect, process and bank their stem cells.
NeoStem intends to provide this service.
Initial
participants in our collection center network have been single physician
practices who opened collection centers in California, Pennsylvania and Nevada.
Revenues generated by these early adopters have not been significant and are not
expected to become significant. However, these centers have served as a platform
for the development of NeoStem’s business model and today NeoStem is focusing on
multi-physician and multi-specialty practices joining its network in major
metropolitan areas but continues to align with physicians that have a client
base who have indicated a particular interest in stem cell collection and
storage. Toward this end, NeoStem signed an agreement in June 2008
for a New York City stem cell collection center to be opened by Bruce Yaffe,
M.D., of Yaffe, Ruden and Associates, which facility became operational in
November 2008. In July 2008, NeoStem signed an agreement for a Santa Monica,
California based stem cell collection center to be opened by Stem Collect of
Santa Monica LLC at The Hall Center. This facility became operational
in the fall of 2008. Additionally, NeoStem signed an agreement with Celvida LLC
pursuant to which a Southern Florida stem cell collection center located in
Coral Gables, a suburb of Miami, became operational in September
2008. In March 2009, the Company signed an agreement to open a
collection center with the Giampapa Institute for Anti-Aging Medical Therapy in
Montclair, New Jersey. In addition, in May 2009 the Company entered into a
collection agreement with Primary Care of Malibu in California.
During
2008, parallel to growing the platform business and the efforts we undertook in
that regard to establish a network of collection centers in certain major
metropolitan areas of the United States to drive growth, we recognized the need
to acquire a revenue generating business in the United States or abroad and
began exploring acquisition opportunities of revenue generating
businesses. In November 2008, NeoStem entered into the Merger
Agreement with China Biopharmaceuticals Holdings, Inc. (“CBH”) to acquire the
51% interest in Suzhou Erye Pharmaceuticals Company Ltd. (“Erye”) a Sino-foreign
limited liability joint venture organized under the laws of the PRC, which has
been in business for more than 50 years and currently manufactures over 100
drugs on seven Good Manufacturing Practices (GMP) lines, including small
molecule drugs. Erye specializes in research and development, production and
sales of pharmaceutical products, as well as chemicals used in pharmaceutical
products. Also in November 2008, NeoStem entered into the Share Exchange
Agreement to obtain benefits from Shandong New Medicine Research Institute of
Integrated Traditional and Western Medicine Limited Liability Company, a China
limited liability company, which is engaged in the business of research,
development, popularization and transference of regenerative medicine technology
(except for those items for which it does not have special approval) in the
PRC. Subject to the fulfillment of various closing conditions
(including stockholder approval), the Merger and the Share Exchange are
currently anticipated to close in the third quarter of 2009.
The
Company has begun other initiatives to expand its operations into China
including with respect to technology licensing, establishment of stem cell
processing and storage capabilities and research and clinical
development. RimAsia, a principal stockholder of the Company, has
been facilitating certain of these efforts and has paid certain expenses that
the Company has agreed to reimburse (approximately $473,000 of which was
reimbursed out of the proceeds of the private placement financing of preferred
stock and warrants in April 2009 which raised gross proceeds of $11 million,
described below). The Company is taking steps to establish a separate
wholly foreign owned enterprise (a “WFOE”) and one or more limited liability
companies and put in place separate variable interest entity documents with
respect to these activities. The Company is exploring the possibility
of these expansion activities and other activities being a substitute for its
moving forward with closing the transactions under the Share Exchange
Agreement.
In
February and March 2009, in order to move forward certain research and
development activities, strategic relationships in various clinical and
therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, the Company issued promissory notes (the “RimAsia Notes”) totaling
$1,150,000 to RimAsia, which notes bore interest at a rate equal to 10% per
annum and mature on October 31, 2009 except that they matured earlier in the
case of an equity financing by the Company that raised in excess of
$10,000,000. The RimAsia Notes plus accrued interest were paid in April
2009 (as described below).
The
acquisition of the VSEL technology was made through our acquisition of our
subsidiary Stem Cell Technologies, Inc. (“SCTI”) in a stock-for-stock
exchange. Although the funds obtained through the acquisition of SCTI
funded certain early obligations under NeoStem’s agreements relating to the VSEL
technology, substantial additional funds will be needed and additional research
and development capacity will be required to meet its development obligations
under the License Agreement and develop the VSEL
technology. NeoStem has applied for Small Business Innovation
Research (SBIR) grants and may also seek to obtain funds through applications
for other State and Federal grants, grants abroad, direct investments, strategic
arrangements as well as other funding sources to help offset all or a portion of
these costs.
During
the quarter ended March 31, 2009 the Company took steps to improve its
cryopreservation operations and reduce its fixed overhead by entering into a
four year agreement with Progenitor Cell Therapy LLC (“PCT”) to outsource
cryopreservation operations to PCT. Prior to commencing these services, PCT
agrees to provide certain preliminary services consisting of technology transfer
and protocol review and revision to ensure that the processing and storage
services are cGMP compliant. The agreement sets forth agreed upon
fees for the delivery of the services as well as providing for a one-time
payment of $35,000 for the preliminary services associated with the transfer of
the Company’s cryopreservation process and standard operating
practices to PCT’s laboratory and incorporation into PCT’s existing
standard operating practices. An initial payment of $20,000 was paid
upon commencement of services during the quarter ended March 31,
2009. The transfer of cryopreservation operations was completed in
April 2009, the final $15,000 was paid and the Company’s laboratory in Los
Angeles is being closed. The Company does not anticipate any significant losses
as a result of closing this laboratory. In addition, the Company believes the
shifting of our cryopreservation activities from a fixed cost to a variable cost
will allow the Company to utilize its cash in a more strategic
fashion.
In March
2009, the Company and PCT expanded PCT’s services to include its developing a
plan to set up a stem cell processing and manufacturing operation in Beijing,
China that the Company would pursue in partnership with an off-shore
entity. This plan would support research and cell therapy development
and manufacturing operations. The plan will include a conceptual
architectural design, cost estimates for construction, facility validation to
meet cGMP standards, equipment requirements and estimated costs of equipment
procurement, and other related matters. PCT’s fees for this work will
be $100,000 (of which $50,000 was paid in March 2009) plus
expenses.
In order to advance our regenerative
medicine business here and abroad, in February 2009, the
Company entered into a
License Agreement with Vincent Giampapa, M.D., F.A.C.S pursuant to which the Company
acquired a world-wide, exclusive, royalty bearing, perpetual and
irrevocable license, with the right to sublicense, to certain innovative
stem cell technology and applications for cosmetic facial and body procedures
and skin rejuvenation. In addition, in January 2009, the Company and Dr.
Giampapa entered into a three year consulting agreement whereby Dr. Giampapa
will provide consulting services in the anti-aging area.
In order to advance our regenerative
medicine business abroad and expand our expertise into a new area, effective
March 2009, the Company entered into a License Agreement with
Regenerative Sciences, LLC (“RSI”), pursuant to which the Company
acquired an exclusive, royalty bearing, perpetual and irrevocable license,
with the right to sublicense, for the Asia territory, to use an innovative
process that rapidly grows a patient’s own adult stem cells to treat a variety
of musculoskeletal diseases. The licensed procedure has been
developed by RSI, a Colorado-based company focused on developing a medical
procedure for the treatment of chronic orthopedic conditions. In
addition, effective March 2009, the Company and RSI entered into a three
year consulting agreement whereby RSI will provide to the Company consulting
services in the area of stem cell therapy in orthopedics for the development of
business in Asia.
In April 2009, the Company entered into a
License Agreement with Vincent Falanga, M.D., pursuant to which the Company
acquired a world-wide, exclusive, royalty bearing license, with the right
to sublicense, to certain innovative stem cell technology and
applications for wound healing, continuing until the later of ten years from the
first commercial sale or the last to expire patent claim.
All of
the activities above are designed to broaden the scope of the Company’s
operations and to enter into the arena of advanced stem cell and regenerative
medicine therapies in the United States and China. While the Company continues
to pursue its platform business of operating a commercial autologous adult stem
cell bank, it has made a determination that the platform business will be
enhanced if the Company acquires and develops advanced stem cell regenerative
medicine therapies.
RESULTS
OF OPERATIONS
Three
Months Ended March 31, 2009 Compared to Three Months Ended March 31,
2008
For the
three months ended March 31, 2009, total revenues were $45,100 compared to $700
for the three months ended March 31, 2008. The revenues generated in
the three months ended March 31, 2009 were a combination of stem cell collection
fees and monthly stem cell storage fees and the revenues generated in the three
months ended March 31, 2008 were from monthly stem cell storage fees in the
period.
Selling,
general and administrative expenses for the three months ended March 31, 2009
have decreased by $645,800 or 26% over the three months ended March 31, 2008,
from $2,524,300 to $1,878,500. This decrease in expense is the result of
management decisions to reduce various expenses to conserve cash and reduce our
operating expenses. During the last two years the Company has used a variety of
equity instruments to pay for services in an effort to minimize its use of cash
to incentivize staff, consultants and other service providers and in the quarter
ending March 31, 2009 the reduced use of equity instruments was the primary
source of decrease in operating expenses. The reduced use of equity instruments
to pay for staff compensation, director fees, marketing activities, investor
relations and other activities decreased our operating expenses by $1,093,400.
Operating expenses funded by cash were $1,671,000 for the three months ended
March 31, 2009 compared with $1,199,000 in cash funded expenses for the three
months ended March 31, 2008, an increase of $447,000. The increase in cash
expenses was primarily related to an increase in legal and professional
services, of $284,600, utilized to prepare for public filings and shareholder
approval of our proposed merger with CBH and our expansion into China, payments
of $66,000 to the University of Louisville in connection with our obligations
for the VSEL technology licensed in November 2007, payments totaling $70,000 to
plan the establishment of stem cell collection cryopreservation operations
in China and to outsource our US stem cell cryopreservation operations to
Progenitor Cell Therapy, an increase in consulting fees of $78,900, expenses
totaling $45,000 associated with the filing of an additional shares
listing application with the NYSE Amex for additional shares being listed by the
Company in connection with the adoption of the 2009 Plan, an increase in
depreciation and amortization of $30,200 due primarily to amortization of
intangible assets, an increase in legal fees of $29,800 associated with
corporate governance and other matters and prepaid computer licenses and an
increase in occupancy cost of $8,800. These increases were offset by reductions
in salary and benefits of $52,700 as a result of staff reductions, a reduction
in marketing expense of $84,300 due to concentrating our efforts on recruiting
clients in the New York and Southern California areas, a reduction in investor
relations and communications of $22,800 and a reduction in other expenses
netting $6,600.
Interest
expense increased by $7,000 as a result of the RimAsia Notes issued in February
and March 2009 to RimAsia totaling $1,150,000.
For the
reasons cited above the net loss for the three months ended March 31, 2009 was
reduced to $1,867,200 from $2,527,000 for the three months ended March 31,
2008.
LIQUIDITY
AND CAPITAL RESOURCES
General
At March
31, 2009, the Company had negative working capital of $2,074,000. The
Company generates revenues from its adult stem cell collection activities,
however, our revenues generated from such activities have not been
significant. During the first quarter 2009, the Company issued
promissory notes to RimAsia (the “RimAsia Notes”), a principal stockholder of
the Company, which aggregated $1,150,000 (see Note 4 - Notes Payable). On April
9, 2009, Company completed a private placement financing totaling $11 million
from three Asia-based investors, including RimAsia. The financing
consisted of the issuance of 880,000 units priced at $12.50 per unit, with each
unit consisting of one share of the Company’s Series D Convertible Redeemable
Preferred Stock (“Series D Stock”) (convertible into 10 shares of Common Stock)
and ten warrants each to purchase one share of common stock. The conversion of
the Series D Stock and the exercise of warrants is subject to shareholder
approval and the rules of NYSE Amex as described in Note 8 – Subsequent Events.
If by October 31, 2009 such shareholder approval of the conversion of Series D
Stock is not achieved, the Company must redeem all shares of Series D Stock at a
redemption price per share of $12.50 plus the accrued dividends as of such
date. The Series D Stock has an accruing dividend of ten percent
(10%) per annum, payable (i) annually in cash on each anniversary of the issue
date so long as the Series D Stock remains outstanding or (ii) upon a
liquidation, dissolution or winding up of the Company. The Series D
Stock ranks senior to all of the Company’s capital stock with respect to the
payment of dividends and to the distribution of assets upon liquidation,
dissolution or winding up. The warrants will be exercisable for 5
years and have a per share exercise price equal to $2.50 and are
callable by the Company if the Common Stock trades at a price equal to a minimum
of $3.50 for a specified period of time.
As a
result of NeoStem exploring acquisition opportunities of revenue generating
businesses, in November 2008 NeoStem entered into the Merger Agreement with CBH
to acquire the 51% ownership interest in Erye, which manufactures over 100 drugs
on seven cGMP lines and the Share Exchange Agreement with respect to Shandong
which is engaged in the business of research, development, popularization and
transference of regenerative medicine technology (except for those items for
which it does not have special approval) in the PRC. The Company is
also engaged in other initiatives to expand its operations into China including
with respect to technology licensing, establishment of stem cell processing and
storage capacities and research and clinical development. The Company
has incurred and expects to continue to incur substantial expenses in connection
with these China activities. The acquisition transactions are not
expected to close before the third quarter of 2009 and in any event neither the
acquisition transactions nor the Company’s other initiatives in China are
expected to generate sufficient excess cash flow to support NeoStem’s platform
business or its initiatives in China in the near term. The Company is
exploring the possibility of its other initiatives in China being a substitute
for its moving forward with closing the transactions under the Share Exchange
Agreement.
The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period
indicated:
|
|
Three
Months Ended
|
|
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
Cash
used in Operating activities
|
|
$ |
(1,253,000 |
) |
|
$ |
(1,401,700 |
) |
Cash
used in investing activities
|
|
$ |
(5,700 |
)
)) |
|
$ |
(2,400 |
) |
Cash
provided by financing activities
|
|
$ |
1,220,700
|
|
|
$ |
69,700
|
|
At March
31, 2009 the Company had a cash balance of $392,800, negative working capital of
$2,074,000 and a negative stockholders’ equity of $804,400. The Company incurred
a net loss of $1,867,200 for the three months ended March 31,
2009. Our cash used for operating activities in the three months
ended March 31, 2009 totaled $1,253,000 which reflects adjustments of
our net loss of $1,867,200 for non-cash items, including common stock, common
stock option and common stock purchase warrant issuances related to services
rendered of $199,600 and depreciation and amortization of $29,900; an adjustment
for cash retained within the Company as a result of increases
in various accounts payable, notes payable, accrued liabilities and
unearned revenue totaling $433,500 and an adjustment for cash
required for our operating activities reflected in increases in prepaid
insurance expenses and accounts receivable of $48,700.
The
Company relied on the RimAsia Notes issued to RimAsia for $1,150,000 and its
existing cash balances to meet its cash requirement for the three months ended
March 31, 2009. In April the Company completed a private placement financing
totaling $11 million which will be used to fund current
operations. Approximately $1,162,000 of such gross proceeds was
utilized to repay the RimAsia Notes plus accrued interest and approximately
$473,000 was utilized to reimburse RimAsia for certain costs advanced by RimAsia
in connection with the Company’s expansion activities into China. The Company
believes that it will need to raise additional capital to fund its expansion
into advanced technologies and therapies in the US and China including with
respect to its VSEL technology licensed from the University of Louisville and
its other regenerative technologies, including relating to anti-aging of skin,
wound healing and orthopedic applications. It currently intends to
accomplish this through additional financing activities, acquisitions of revenue
generating businesses and ultimately the growth of its revenue generating
activities in China. In addition the Company will seek grants for scientific and
clinical studies from the National Institutes of Health and other funding
agencies but there is no assurance that we will be successful in obtaining such
grants. It also anticipates that certain of its recent collaborative marketing
efforts will drive revenues particularly in its stem cell collection business.
The Company’s history of losses and liquidity problems may make it difficult to
raise additional funds. There can be no assurance that the Company will be
successful in obtaining additional funding on terms acceptable to the Company or
otherwise generating additional capital or revenue. Any equity financing may be
dilutive to stockholders and debt financing, if available, may involve
significant restrictive covenants.
SEASONALITY
NeoStem
does not believe that its operations are seasonal in nature.
OFF-BALANCE
SHEET ARRANGEMENTS
NeoStem
does not have any off-balance sheet arrangements.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
Not
applicable to smaller reporting companies.
ITEM
4T. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Disclosure
controls and procedures are the Company’s controls and other procedures that are
designed to ensure that information required to be disclosed in the reports that
the Company files or submits under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) is recorded, processed, summarized and reported in
a complete, accurate and appropriate manner, within the time periods specified
in the Securities and Exchange Commission’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in the reports that the Company
files under the Exchange Act is accumulated and communicated to management,
including the Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required disclosure. As of the
end of the Company’s first fiscal quarter ended March 31, 2009
covered by this report, the Company carried out an evaluation, with the
participation of the Company's management, including the Company's Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the
Company's disclosure controls and procedures pursuant to Rule 13a-15 of the
Exchange Act. Based on that evaluation, the Company's Chief Executive Officer
and Chief Financial Officer concluded that the Company's disclosure controls and
procedures were effective to reasonably ensure that information required to be
disclosed by the Company in the reports that it files or submits under the
Securities Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the SEC's rules and forms and is accumulated and
communicated to management, including the Chief Executive Officer and Chief
Financial Officer, as appropriate to allow timely decisions regarding required
disclosure. Due to the inherent limitations of control systems,
not all misstatements may be detected. These inherent limitations include the
realities that judgments in decision-making can be faulty and the breakdowns can
occur because of a simple error or mistake. Additionally, controls can be
circumvented by the individual acts of some persons, by collusion of two or more
people, or by management override of the control. Our controls and procedures
can only provide reasonable, not absolute, assurance that the above objectives
have been met.
Changes
in Internal Controls Over Financial Reporting
There
have been no changes in the Company's internal controls over financial
reporting, as such term is defined in Exchange Act Rule 13a-15, that occurred
during the quarter ended March 31, 2009 that have materially affected, or are
reasonably likely to materially affect, the Company's internal control over
financial reporting.
NEOSTEM,
INC.
PART
II
OTHER
INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Previously
reported on the Company’s Annual Report on Form 10-K for the year ended December
31, 2008.
ITEM
1A. RISK FACTORS
Not
applicable to smaller reporting companies.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
Previously
reported on the Company’s Current Report on Form 8-K dated April 13, 2009, and
as follows:
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relation services to the Company since 2005, pursuant to
which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The issuance of such securities is
subject to the approval of the NYSE Amex.
In
January 2009, the Company issued to its grant consultant 20,000 shares of
restricted Common Stock as a bonus under the consultant’s Consulting Agreement
with the Company dated February 8, 2008, in consideration for such consultant
being instrumental in securing the Company’s inclusion in the Department of
Defense Fiscal Year 2009 Appropriations Bill in the net amount of approximately
$680,000. The issuance of such securities was subject to the approval
of the NYSE Amex, which approval was obtained in January 2009. The
Company has entered into a new consulting agreement with such grant consultant
for a one-year term commencing as of January 1, 2009, pursuant to which it will
provide assistance to the Company in the following areas: (i) with
regard to negotiation, drafting and finalization of contracts; (ii) in the
development of strategic plans; (iii) with regard to funding from various
agencies of the State of New Jersey and Federal government; and (iv) with other
assignments it may receive from time to time. In consideration for
such services, the consultant will be issued shares of the Company’s restricted
Common Stock equal to a value of $60,000 based on the closing price of the
Company’s Common Stock on the date of execution of the agreement, which has been
determined to be 67,416 shares, to vest as to one-half of such shares on June
30, 2009 and the remaining one-half of such shares on December 31,
2009. The issuance of such securities is subject to the approval of
the NYSE Amex.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock pursuant to the terms of a three month consulting
agreement entered into in October 2008, scheduled to vest pursuant to the
agreement as to 4,000 shares at the end of each 30 day period during the
term. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in January 2009.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of restricted Common Stock at a purchase price of $1.40
per share. This warrant was issued in consideration of services rendered after
the expiration of an October 2007 consulting agreement with the Company pursuant
to which this consultant was engaged to create marketing materials for our sales
and marketing staff. The issuance of this warrant was subject to the approval of
the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant which has been
providing financial market related services to the Company since 2008, pursuant
to which this consultant was retained to provide additional financial market
related services for a three month period. In partial consideration
for providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, to vest as
to one-third of the shares at the end of each monthly period during the term and
a five year warrant to purchase 25,000 shares of restricted Common Stock at a
per share exercise price of $1.00, vesting in its entirety at the end of the
term. The issuance of such securities is subject to the approval of the
NYSE Amex.
On May 1,
2009, the Company entered into a three year consulting agreement effective March
3, 2009 (the “Effective Date”) whereby the consultant will provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia. Pursuant to this agreement, as
partial compensation for such services, the Company agreed to issue to this
consultant a warrant to purchase up to an aggregate of 24,000 shares of Common
Stock at an exercise price of $0.50 (the closing price of the Common Stock on
the Effective Date) which shall vest and become exercisable as to one-third of
such shares on each of the first, second and third anniversaries of the
Effective Date. The issuance of such securities is subject to the
approval of the NYSE Amex.
The offer
and sale by the Company of the securities described above were made in reliance
upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended (the “Securities Act”), for transactions by
an issuer not involving a public offering. The offer and sale of such securities
were made without general solicitation or advertising to “accredited investors,”
as such term is defined in Rule 501(a) of Regulation D promulgated
under the Securities Act.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM
5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
(a) Exhibits
4.1
Certificate of Designations for Series D Preferred Stock (1)
4.2
Form of Warrant issued in connection with April 2009 private placement
(1)
4.3
Form of subscription agreement (1)
10.1
Amendment No. 1 to Sponsored Research Agreement between NeoStem, Inc. and the
University of Louisville Research Foundation, Inc.*
10.2
Amendment No. 1 to Exclusive License Agreement between Stem Cell Technologies,
Inc. and the University of Louisville Research Foundation, Inc.*
31.1
Certification of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
31.2
Certification of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
32.1
Certification of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.**
32.2
Certification of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.**
|
(1)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated April 13, 2009, which exhibit is incorporated
here by reference.
|
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 thereunto
duly authorized.
|
NEOSTEM, INC.
(Registrant) |
|
|
|
|
|
|
By:
|
/s/ Robin
Smith M.D. |
|
|
|
Robin
Smith M.D., Chief Executive Officer |
|
|
|
|
|
|
Date:
May 15, 2009 |
|
|
By:
|
/s/ Larry
A. May |
|
|
|
Larry
A. May, Chief Financial Officer |
|
|
|
|
|
|
Date:
May 15, 2009 |
|
University
of Louisville Research Foundation
Amendment
No. 1 to
Sponsored
Research Agreement
THIS
Amendment No. 1 (“Amendment”) is made and effective as of the last date of
signature below (“Effective Date”), by and between the University of Louisville
Research Foundation, Inc. (hereinafter “ULRF”) a Kentucky non-profit corporation
having an office at MedCenter One, 501 E. Broadway, Suite 200, Louisville, KY
40202-1798 as the agent of the University of Louisville (hereinafter "UofL") for
receiving grants and research agreements from external funding sources and which
owns and controls intellectual property on behalf of UofL (collectively
“Institution”) and NeoStem, Inc. with a principal place of business at 420
Lexington Avenue, Suite 450, New York, NY 10170 (hereinafter
“SPONSOR”).
WHEREAS,
ULRF and SPONSOR entered into that certain Sponsored Research Agreement as of
November 13, 2007 (the “Original Agreement”); and
WHEREAS,
ULRF and SPONSOR wish to amend the Original Agreement to amend the research
program set forth therein to provide for certain additional research in return
for receiving certain rights in the research results and to provide for support
related to such additional research.
NOW,
THEREFORE, the parties hereto agree as follows:
Unless
otherwise set forth herein, initially capitalized terms not otherwise defined
herein shall have the meaning ascribed to them in the Original
Agreement.
The
Research Plan is hereby amended to provide that the research set forth in
Appendix A-1 hereto (“Pre-Aim 1”) shall become part of the Original Agreement
and Pre-Aim 1 shall be conducted prior to the conduct of the Research set forth
in the Original Agreement. SPONSOR will use its best reasonable
efforts to provide to Principal Investigator no later than October 17, 2008 the
de-identified samples required for Institution’s performance of its portion on
Pre-Aim 1. Institution will use its best reasonable efforts to
complete its portion of Pre-Aim 1 within a period of two (2) months from the
date of receipt of such necessary samples from SPONSOR.
Sponsor
has been advised by Institution that the Pre-Aim 1 protocol titled “Isolation of
Very Small Embryonic like Stem Cells (VSELS) from Peripheral Blood after G-CSF
mobilization”, IRB tracking # 08.0255, was determined by the University of
Louisville Institutional Review Board (IRB) to be an Exempt study as defined by
the IRB and unless said protocol is modified, no further continuing review
and/or approvals are required for the research study under Pre-Aim
1. Institution acknowledges that, upon receipt of the apheresis
product referred to in Pre-Aim 1, Pre-Aim 1 shall commence
promptly.
4.1 In
consideration of ULRF’s performance hereunder and under the Original Agreement,
SPONSOR agrees to support costs incurred in performance of the Research in the
aggregate amount of Three Hundred Ninety-Nine Thousand Five Hundred Twelve U.S.
Dollars (US$399,512), inclusive of applicable Facilities & Administrative
Costs calculated at Institution’s rate in effect as of the Effective Date of the
Original Agreement on the terms set forth herein and therein. It is
acknowledged that of this amount, $375,000 relates to the Research under the
Original Agreement and $24,512 relates to Pre-Aim 1. As of the date
of this Amendment, no amounts are payable under the Original Agreement;
provided, however, that on April 3, 2008, SPONSOR prepaid $50,000 under the
Original Agreement. ULRF and
SPONSOR
agree that the this $50,000 prepayment shall be credited to the $24,512 payable
for the conduct of Pre-Aim 1 of the Additional Research on the date that Pre-Aim
1 commences.
NO OTHER CHANGES
Except as
set forth in this Amendment, the terms of the Original Agreement shall remain
unchanged and the rights and obligations of the parties under the Original
Agreement shall apply equally to the conduct of Pre-Aim 1 provided for
hereby.
[remainder
of page left blank intentionally]
IN WITNESS WHEREOF, the
parties hereto have executed this Agreement as of the date first above
written.
THE
UNIVERSITY OF LOUISVILLE
|
|
NEOSTEM,
INC.
|
RESEARCH
FOUNDATION, INC.
|
|
|
|
|
|
|
|
|
Signature:
|
/s/
David D. King
|
|
Signature:
|
/s/
Robin Smith
|
|
|
|
|
|
Printed
Name:
|
David
D. King
|
|
Printed
Name:
|
Robin
Smith
|
|
|
|
|
|
Title:
|
Director,
Office of Industry Contracts
|
|
Title:
|
CEO
|
|
|
|
|
|
Date:
|
10/7/2008
|
|
Date:
|
10/3/08
|
Principal
Investigator, while not a party to this Agreement, by his/her signature
acknowledges that he/she: (1) has read and agrees to abide by the terms and
conditions that apply to the Principal Investigator, (2) agrees to
conduct/perform the research as outlined in the Research Statement of Work, and
(3) if applicable, will see that the work within the scope of this agreement is
performed in accordance with an approved University/Institution management
plan.1
Name:
|
Mariusz
Z. Ratajczak, M.D., Ph.D.
|
|
|
|
|
Signature:
|
/s/
Mariusz Z. Ratajczak
|
|
|
|
|
Title:
|
Professor,
Medical Oncology
|
|
|
|
|
Date:
|
10/7/08
|
|
1 “Management
Plan" means a written plan for the management, reduction or elimination
of a potential financial conflict of interest relating to research. It relies
upon, and is therefore limited by, good faith disclosures about significant
financial interests made, and other information provided by, a covered
individual to the University.
AMENDMENT
NO. 1 TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
UNIVERSITY
OF LOUISVILLE RESEARCH FOUNDATION, INC.
AND
STEM
CELL TECHNOLOGIES, INC.
This
Amendment No. 1 (the “Amendment”) is entered into this 27th day of February 2009
to that exclusive license agreement (the "Original Agreement") entered into the
12th day of November 2007 by and between the University of Louisville Research
Foundation, Inc. ("ULRF"), a Kentucky 501 (c) 3 non-profit
corporation having an office at Med Center Three, 201 E. Jefferson Street, Suite
215, Louisville, KY 40202 as the agent of the University of Louisville ( “UofL”)
and Stem Cell Technologies, Inc. (“LICENSEE”), a Florida corporation and
wholly-owned subsidiary of NeoStem, Inc., a Delaware corporation, each with its
principal place of business located at 420 Lexington Avenue, Suite 450, New
York, New York 10021.
RECITALS
|
WHEREAS,
ULRF and Licensee entered into the Original Agreement whereby Licensee
licensed the rights to the Licensed Technology for the commercial
development, use and sale of the Licensed
Technology.
|
|
WHEREAS,
ULRF and Licensee after discussion desire to amend certain terms of the
Original Agreement as hereinafter
described;
|
|
WHEREAS,
in consideration of the mutual promises contained herein and other good
and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged.
|
NOW, THEREFORE, ULRF and
LICENSEE hereby agree as follows:
|
1.
|
Section
5.1 of the Original Agreement is hereby amended to read in its entirety as
follows:
|
“5.1 License
Issue Fee. LICENSEE shall pay to ULRF a non-creditable,
non-refundable License Issue Fee of forty six thousand dollars
($46,000). Said License Issue Fee shall be payable no later than five
(5) business days after the full execution of this Amendment.”
|
2.
|
Section
6.1.2.2 of the Original Agreement is hereby amended to read in its
entirety as follows:
|
“6.1.2 .2 Prepayment of Future Patent
Office Expenses. No later than five (5) business days after
the full execution of this Amendment, Licensee shall pay a non-refundable twenty
thousand dollars ($20,000), which shall be creditable against the first twenty
thousand ($20,000) of patent expenses incurred after the Effective Date of this
Agreement.”
|
3.
|
“Section
3.3 – Development Plan” shall be amended to read in its entirety as
follows:
|
3.3 Development
Plan. Upon execution of this Agreement, LICENSEE shall submit
an initial Development Plan outlining work to be completed during the first two
and one-half (2.5) years of the Research Period (as defined in the Sponsored
Research Agreement described in Section 3.6 herein), which shall also serve as
the research plan of the Sponsored Research Agreement. No later than
December 31, 2010, LICENSEE shall provide ULRF with a list of its desired,
specific fields of use of the Licensed Technology and the definition of Field of
Use set forth in 1.1.3 shall be deemed amended accordingly. No later than June
30, 2011, LICENSEE will provide ULRF with a draft Development Plan written in
the format set forth in Exhibit D for each specific field of use of the Licensed
Technology included on the aforementioned list, satisfactory to ULRF, in its
reasonable discretion and describing the steps it intends to take which it
believes in good faith will result in allowing the inventions of the Licensed
Patents to be utilized to provide Licensed Products for sale in the commercial
market, which shall further include those steps taken, or to be taken, by
Affiliates and sublicensees, as it may have been advised by Affiliates and
sublicensees. For each specified field of use included on the
aforementioned list for which ULRF does not receive a timely Development Plan
from LICENSEE satisfactory to ULRF in its reasonable discretion, ULRF may
withdraw that field of use from this Agreement the definition of Field of Use in
1.1.3 shall again be deemed amended to reflect the narrowed fields of use and
ULRF may license such use to a third party, subject to prior notice to Licensee
and an opportunity to cure as set forth in Section
12.1.1.1. For each new field of use desired by LICENSEE but not
included on the list submitted to ULRF by LICENSEE, LICENSEE may request the
addition of the new field(s) of use and its corresponding Development Plan to
this Agreement in accordance with Section 13.3 of this Agreement.
Except as set forth herein, the
Original Agreement shall remain unchanged. Initially capitalized
terms not otherwise described herein shall have the meaning set forth in the
Original Agreement.
THEREFORE,
the parties have executed this Agreement in duplicate originals by their duly
authorized officers or representatives.
UNIVERSITY
OF LOUISVILLE
RESEARCH
FOUNDATION, INC.
/s/ James R.
Zanewicz
James
R. Zanewicz, Director
Date
3/4/09
|
Stem
Cell Technologies Inc.
/s/ Robin
Smith
Robin Smith, President
Date 2/28/2009
|
Exhibit
31.1
CERTIFICATION
I, Robin
Smith, M.D., certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b)
Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date:
May 15, 2009
/s/ Robin Smith,
M.D.
Name:
Robin Smith, M.D.
Title:
Chief Executive Officer of NeoStem, Inc.
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
31.2
CERTIFICATION
I, Larry
A. May, certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b)
Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date: May
15, 2009
/s/ Larry A.
May
Name:
Larry A. May
Title:
Chief Financial Officer of NeoStem, Inc.
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report
of NeoStem, Inc. (the “Company”) on Form 10-Q for the period ended March 31,
2009 filed with the Securities and Exchange Commission on the date hereof (the
“Report”), I, Robin Smith, M.D., Chief Executive Officer of the Company,
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002, that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: May
15, 2009
/s/ Robin Smith,
M.D.
Robin
Smith, M.D.
Chief
Executive Officer
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report
of NeoStem, Inc. (the “Company”) on Form 10-Q for the period ended March 31,
2009 filed with the Securities and Exchange Commission on the date hereof (the
“Report”), I, Larry A. May, Chief Financial Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended ;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: May
15, 2009
/s/ Larry A.
May
Larry A.
May
Chief
Financial Officer
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.