|
OMB
APPROVAL
|
OMB
Number: 3235-0416
Expires:
January 31, 2007
Estimated
Average burden
Hours
per response
136
|
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
Delaware
|
|
02-0563870
|
(State
or other jurisdiction of incorporation or organization)
|
|
(IRS
Employer Identification No.)
|
|
Page
No.
|
|
|
|
|
|
|
|
|
||
|
|
|
|
Item
1. Condensed Financial Statements
|
|
|
|
|
|
|
|
Balance
Sheet at July 31, 2007 (unaudited)
|
|
3
|
|
|
|
|
|
Statements
of Operations for the three and nine month periods ended July 31,
2007 and
2006 (unaudited), and the period March 1, 2002 (inception) to July
31,
2007 (unaudited)
|
|
4
|
|
|
|
|
|
Statement
of Cash Flows Statements for the nine month periods ended July 31,
2007
and 2006 and the period March 1, 2002 (inception) to July 31, 2007
(unaudited)
|
|
5
|
|
|
|
|
|
Notes
to Condensed Financial Statements
|
|
7
|
|
|
|
|
|
Item
2. Management’s Discussion and Analysis
|
|
12
|
|
|
|
|
|
Item
3. Controls and Procedures
|
|
16
|
|
|
|
|
|
|
|
||
|
|
|
|
|
16
|
|
|
|
|
|
|
|
17
|
|
|
|
|
|
|
|
18
|
|
|
|
|
|
|
CERTIFICATIONS
|
|
|
|
July
31,
2007
|
|||
|
||||
Current
Assets:
|
|
|||
Cash
|
$
|
115,361
|
||
Prepaid
expenses
|
43,915
|
|||
Total Current Assets
|
159,276
|
|||
|
||||
Property
and Equipment (net of accumulated depreciation of $47,452)
|
120,184
|
|||
Intangible
Assets (net of accumulated amortization of $134,632)
|
938,080
|
|||
Deferred
Financing Costs (net of accumulated amortization of
$179,435)
|
80,565
|
|||
Other
Assets
|
3,875
|
|||
|
||||
Total
Assets
|
1,301,980
|
|||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
1,117,122
|
|||
Accrued
expenses
|
309,345
|
|||
Notes
payable - current portion
|
70,367
|
|||
Total
Current Liabilities
|
1,496,834
|
|||
|
||||
Interest
payable
|
225,819
|
|||
Notes
payable - net of current portion
|
115,125
|
|||
Convertible
Secured Debentures and fair value of embedded derivative
|
2,878,023
|
|||
Common
Stock Warrants
|
821,010
|
|||
Total
Liabilities
|
5,536,811
|
|||
|
||||
Shareholders’
Deficiency:
|
||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued
and
outstanding
|
-
|
|||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 46,059,830 shares
|
46,060
|
|||
Additional
Paid-In Capital
|
7,435,742
|
|||
Deficit
accumulated during the development stage
|
(11,716,633
|
)
|
||
Total
Shareholders' Deficiency
|
(4,234,831
|
)
|
||
Total
Liabilities and Shareholders’ Deficiency
|
$
|
1,301,980
|
3
Months Ended July 31,
2007
|
3
Months Ended July 31,
2006
|
9
Months Ended July 31,
2007
|
9
Months Ended July 31,
2006
|
Period
from
March
1, 2002 (Inception) to
July
31,
2007
|
||||||||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
154,201
|
$
|
397,312
|
$
|
1,259,436
|
||||||
|
||||||||||||||||
Research
& Development Expenses
|
372,434
|
262,257
|
1,397,033
|
1,098,190
|
4,645,081
|
|||||||||||
General
& Administrative Expenses
|
448,492
|
426,497
|
2,296,393
|
1,444,068
|
6,640,186
|
|||||||||||
Total
Operating expenses
|
820,926
|
688,754
|
3,693,426
|
2,542,258
|
11,285,267
|
|||||||||||
|
||||||||||||||||
Loss
from Operations
|
(820,926
|
)
|
(688,754
|
)
|
(3,539,225
|
)
|
(2,144,946
|
)
|
(10,025,831
|
)
|
||||||
|
||||||||||||||||
Other
Income (expense):
|
||||||||||||||||
Interest
expense
|
(108,952
|
)
|
(151,100
|
)
|
(474,488
|
)
|
(265,109
|
)
|
(940,516
|
)
|
||||||
Other
Income
|
3,168
|
27,928
|
41,140
|
63,290
|
177,562
|
|||||||||||
Gain
on note retirement
|
-
|
-
|
319,967
|
-
|
319,967
|
|||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
2,044,825
|
128,652
|
1,598,147
|
(101,272
|
)
|
(1,203,931
|
)
|
|||||||||
Net
income (loss)
|
1,118,115
|
(683,274
|
)
|
(2,054,459
|
)
|
(2,448,036
|
)
|
(11,672,748
|
)
|
|||||||
|
||||||||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
43,884
|
|||||||||||
|
||||||||||||||||
Net
income (loss) applicable to Common Stock
|
$
|
1,118,115
|
$
|
(683,274
|
)
|
$
|
(2,054,459
|
)
|
$
|
(2,448,036
|
)
|
$
|
(11,716,633
|
)
|
||
|
||||||||||||||||
Net
income (loss) per share, basic
|
$
|
0.02
|
$
|
(0.02
|
)
|
$
|
(0.05
|
)
|
$
|
(0.06
|
)
|
|||||
Net
income (loss) per share, diluted
|
$
|
0.02
|
$
|
(0.02
|
)
|
$
|
(0.05
|
)
|
$
|
(0.06
|
)
|
|||||
Weighted
average number of shares outstanding, basic
|
45,825,888
|
38,880,998
|
43,568,150
|
38,294,316
|
||||||||||||
Weighted
average number of shares outstanding, diluted
|
54,773,193
|
38,880,998
|
43,568,150
|
38,294,316
|
9
Months ended
July
31,
|
9
Months ended
July
31,
|
Period
from March 1, 2002 (Inception) to July 31,
|
||||||||
|
2007
|
2006
|
2007
|
|||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(2,054,459
|
)
|
$
|
(2,448,036
|
)
|
$
|
(11,672,748
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
net cash used in operating activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
826,769
|
326,108
|
1,537,979
|
|||||||
Amortization
of deferred financing costs
|
97,122
|
39,019
|
179,435
|
|||||||
Non-cash
interest expense
|
264,886
|
144,614
|
495,102
|
|||||||
Accrued
interest on notes payable
|
107,868
|
81,028
|
244,110
|
|||||||
Loss
on change in value of warrants and embedded derivative
|
(1,598,147
|
)
|
101,271
|
1,203,931
|
||||||
Value
of penalty shares issued
|
-
|
-
|
117,498
|
|||||||
Depreciation
expense
|
23,011
|
12,605
|
47,452
|
|||||||
Amortization
expense of intangibles
|
40,077
|
32,311
|
137,803
|
|||||||
Gain
on note retirement
|
(319,967
|
)
|
-
|
(319,967
|
)
|
|||||
(Increase)
in prepaid expenses
|
(5,815
|
)
|
(34,973
|
)
|
(43,915
|
)
|
||||
Decrease
(increase) in other assets
|
725
|
(14,616
|
)
|
(3,875
|
)
|
|||||
Increase
(decrease) in accounts payable
|
428,901
|
148,654
|
1,554,328
|
|||||||
(Decrease)increase
in accrued expenses
|
(213,122
|
)
|
339,981
|
293,156
|
||||||
(Decrease)
in deferred revenue
|
(20,350
|
)
|
-
|
-
|
||||||
Net
cash used in operating activities
|
(2,422,503
|
)
|
(1,272,034
|
)
|
(6,229,711
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(32,873
|
)
|
(6,404
|
)
|
(122,056
|
)
|
||||
Cost
of intangible assets
|
(183,781
|
)
|
(189,546
|
)
|
(1,150,835
|
)
|
||||
Net
cash used in investing Activities
|
(216,654
|
)
|
(195,950
|
)
|
(1,317,831
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
-
|
3,000,000
|
3,000,000
|
|||||||
Cash
paid for deferred financing costs
|
-
|
(260,000
|
)
|
(260,000
|
)
|
|||||
Proceeds
from notes payable
|
-
|
-
|
671,224
|
|||||||
Payment
on notes payable
|
(6,648
|
)
|
-
|
(6,648
|
)
|
|||||
Net
proceeds of issuance of Preferred Stock
|
-
|
-
|
235,000
|
|||||||
Net
proceeds of issuance of Common Stock
|
-
|
-
|
4,023,327
|
|||||||
Net
cash provided by (used in) financing Activities
|
(6,648
|
)
|
2,740,000
|
7,662,903
|
||||||
Net
(Decrease) increase in cash
|
(2,645,805
|
)
|
1,272,016
|
115,361
|
||||||
Cash
at beginning of period
|
2,761,166
|
2,075,206
|
||||||||
Cash
at end of period
|
$
|
115,361
|
$
|
3,347,222
|
$
|
115,361
|
|
9
Months ended
July
31,
|
9
Months ended
July
31,
|
Period
from March 1, 2002
(Inception)
to
|
|||||||
|
2007
|
2006
|
July
31, 2007
|
|||||||
|
||||||||||
Equipment
acquired under capital lease
|
$
|
45,580
|
-
|
$
|
45,580
|
|||||
Common
Stock issued to Founders
|
-
|
-
|
$
|
40
|
||||||
Notes
payable and accrued interest
|
||||||||||
converted
to Preferred Stock
|
-
|
-
|
$
|
15,969
|
||||||
Stock
dividend on Preferred Stock
|
-
|
-
|
$
|
43,884
|
||||||
Notes
payable and accrued interest
|
||||||||||
converted
to Common Stock
|
$
|
700,000
|
$
|
150,000
|
$
|
1,613,158
|
||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
-
|
$
|
512,865
|
$
|
512,865
|
|||||
Allocation
of the original secured convertible debentures to warrants
|
-
|
$
|
214,950
|
$
|
214,950
|
Business
description
|
October
31, 2006
|
July 31, 2007
|
Increase/Decrease
|
||||||||
Trademark
|
$
|
74,948
|
$
|
86,414
|
$
|
11,466
|
||||
License
|
485,123
|
496,127
|
11,004
|
|||||||
Patents
|
490,893
|
490,171
|
(722
|
)
|
||||||
Total
intangibles
|
1,050,964
|
1,072,712
|
21,748
|
|||||||
Accumulated
Amortization
|
(94,555
|
)
|
(134,632
|
)
|
(40,077
|
)
|
||||
Intangible
Assets
|
$
|
956,409
|
$
|
938,080
|
$
|
(18,329
|
)
|
For
the three months ended
|
For
the nine months ended
|
||||||
July
31, 2007
|
July
31, 2007
|
||||||
24,514,999
|
25,009,220
|
||||||
Stock
Options
|
8,512,841
|
8,512,841
|
|||||
Convertible
Debt (1)
|
-
|
8,000,000
|
|||||
Total
All
|
33,027,840
|
41,522,061
|
|||||
2.
|
Secured
Convertible Debenture:
|
Convertible
Secured Debentures due February 1, 2009: 6% per annum
|
$
|
3,000,000
|
||
Common
Stock Warrant liability
|
$
|
(214,950
|
)
|
|
Embedded
derivative liability
|
$
|
(512,865
|
)
|
|
Convertible
Debenture as the date of sale
|
$
|
2,272,185
|
||
Amortization
of discount on warrants & embedded feature as of July 31,
2007
|
$
|
495,103
|
||
Conversion
of Debenture
|
$
|
(1,000,000
|
)
|
|
Convertible
Secured Debenture Liability as of July 31, 2007
|
$
|
1,767,288
|
||
Embedded
Derivative Liability
|
1,110,735
|
|||
Convertible
Secured Debentures and Fair Value of Embedded Derivative Liability
as of
July 31, 2007
|
$
|
2,878,023
|
Amount
of
Conversion
|
Number
of
Shares
|
Conversion
Share
Price
|
||||||||
|
|
|
|
|||||||
June
26, 2007
|
$
|
89,164
|
333,448
|
$
|
.2674
|
|||||
Total
|
$
|
89,164
|
333,448
|
|||||||
|
||||||||||
Inception
to date
|
$
|
1,000,000
|
6,213,725
|
3.
|
SUBSEQUENT
EVENT
|
·
|
Clinical
trial expenses decreased $39,422, or 49%, to $41,567 from $80,989
due to
the higher start-up expenses of our clinical trial in the third quarter
of
Fiscal 2006 compared with lower post recruitment cost in Fiscal
2007.
|
·
|
Manufacturing
expense increased by $75,684 to $77,147 in the Fiscal 2007 Quarter
as
compared with $1,463 incurred in the Fiscal 2006 Quarter due to testing
of
new formulations.
|
·
|
Wages,
salaries and related costs increased $35,811, or 29%, to $160,430
from
$124,619 principally due to expanded research and development
staffing.
|
|
|
·
|
Subcontracting,
lab supplies and consulting expenses increased by $11,244, or 20%,
to
$66,428 from $55,184, primarily due to:
|
|
|
|
·
$49,120
decreased stock option expenses due to the revaluation required
under the
FASB 123R due to decreases in the fair market value and lower consulting
expenses.
|
|
|
|
·
$14,735
increased outside research cost
|
|
|
|
|
|
|
|
·
$9,145
increased lab support and supplies
|
·
|
Toxicology
study expenses increased $26,640 in the Fiscal 2007 Quarter as a
result of
the initiation of toxicology studies to support our IND in 2007;
none were
incurred in the Fiscal 2006
Quarter.
|
·
|
Wages,
option and benefit expenses increased by $118,002, or 168% to $216,025
from $98,023 primarily due to hiring the Chief Executive Officer
in
December 2006.
|
|
|
·
|
Consulting
fees and expenses decreased by $293,354 to ($137,284) from
$156,070.
|
|
·
$242,825
decreased stock option expenses due primarily to the revaluation
required
under FASB 123B due to a decrease in the fair market value and
fewer
options expense in Fiscal Quarter 2007.
|
|
|
|
· $50,529
decreased overall consulting expenses due to fewer consultants
in Fiscal
Quarter 2007.
|
·
|
An
increase primarily from conference and public relations cost of $138,471,
or 374% to $175,471 from $37,000
|
|
|
·
|
An
increase in legal fees of $49,151, or 98%, to $96,677 from $47,526
primarily resulted from task assigned to outside counsel of tasks
related
to SEC filings and fund raising
documents.
|
·
|
Clinical
trial expenses decreased $35,950, or 10%, to $326,525 in Fiscal 2007 from
$362,475 due to higher start-up expenses of our clinical trial which
commenced in the second quarter of Fiscal 2006 compared with lower
post
recruitment expenses in Fiscal 2007.
|
|
|
·
|
Wages,
salaries and related costs increased $154,914, or 41%, to $532,189
in
Fiscal 2007 from $377,275 principally due to our expanded research
and
development staff and bonus accrual.
|
|
|
·
|
Subcontracting,
lab supplies and consulting expenses increased by $85,561, or 28%,
to
$395,306 in Fiscal 2007 from $309,745 primarily due to:
|
|
· $77,486
increased consulting expenses.
|
|
·
$79,396
decreased outside research costs related to supporting
grants.
|
|
· $57,495
increased IND consulting expenses in support of a planned FDA
filing.
|
|
· $29,976
increased lab support and supplies.
|
·
|
Toxicology
study expenses increased by $30,722 in Fiscal 2007 period as a result
of a
study to support our IND in 2007.
|
·
|
Manufacturing
expense increased by $63,595 in Fiscal 2007 period due to a study
of a new
formulation in 2007.
|
·
|
Wages,
options and benefit expenses increased by $382,126, or $154% to $629,717
in Fiscal 2007 from $247,591 due to additions to administrative staff
in
the second quarter Fiscal 2006 and hiring the employment of a Chief
Executive Officer in December 2006.
|
|
|
·
|
Consulting
fees and expenses increased by $239,705, or 40%, to $837,882 in Fiscal
2007 from $598,177. Such increase was primarily attributed to an
amendment
of the consulting agreement with LVEP, an affiliate of Mr. Appel,
A
Director, resulting in: (i) an increase of $295,320 of option expense
(ii)
decrease of his bonus by $4,615; partially offset by a reduction
of
$51,000 in other consulting expenses.
|
|
|
·
|
An
increase in overall expenses of $89,301 for insurance costs of $15,892,
taxes $10,953, depreciation and amortization expenses of $18,172
and
overall operating expenses of $44,284.
|
|
|
An
increase in legal expenses of $9,159, or 4%, to $247,690 from $238,531,
primarily the result of increased task assigned to outside counsel
related
to SEC filings and fund raising documents.
|
|
·
|
An
increase in conference and public relations costs of $132,034 or
118% to
$243,846 from $111,812 due to market studies and conference
attendance.
|
31.1
|
Certification
of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
31.2
|
Certification
of Principal 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
|
|
|
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32.2
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Certification
of Principal Financial Officer pursuant to section 906 of the
Sarbanes-Oxley Act of 2002
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ADVAXIS,
INC.
Registrant
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Date: September
14, 2007
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By:
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/s/ Thomas
Moore
Thomas
Moore
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Chief
Executive Officer and Chairman of the
Board
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By:
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/s/ Fredrick
Cobb
Fredrick
Cobb
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Vice
President Finance, Principal Financial
Officer
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1.
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I
have reviewed this report on Form 10-QSB for the quarter ended July
31,
2007 of Advaxis, Inc.; (the “small business
issuer”);
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2.
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Based
on my knowledge, this 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
report;
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3.
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Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
small
business issuer as of, and for, the periods presented in this
report;
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4.
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The
small business issuer’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) for the small
business issuer and have:
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(a)
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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 small business issuer,
including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
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(b)
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Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation;
and
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(c)
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Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business
issuer’s
most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the small business issuer’s internal control
over financial reporting; and
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5.
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The
small business issuer’s other certifying officer and I have disclosed,
based on our most recent evaluation of internal control over financial
reporting, to the small business issuer’s auditors and the audit committee
of the small business issuer’s board of directors (or persons performing
the equivalent functions):
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(a)
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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 small business issuer’s ability
to record, process, summarize and report financial information;
and
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(b)
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Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
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September
14, 2007
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/s/ Thomas
Moore
Name:
Thomas Moore
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Title:
Chief Executive Officer
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1.
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I
have reviewed this report on Form 10-QSB for the quarter ended July
31,
2007 of Advaxis, Inc.; (the “small business
issuer”);
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2.
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Based
on my knowledge, this 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
report;
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3.
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Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
small
business issuer as of, and for, the periods presented in this
report;
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4.
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The
small business issuer’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) for the small
business issuer and have:
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(a)
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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 small business issuer,
including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
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(b)
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Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation;
and
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(c)
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Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business
issuer’s
most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the small business issuer’s internal control
over financial reporting; and
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5.
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The
small business issuer’s other certifying officer and I have disclosed,
based on our most recent evaluation of internal control over financial
reporting, to the small business issuer’s auditors and the audit committee
of the small business issuer’s board of directors (or persons performing
the equivalent functions):
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(a)
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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 small business issuer’s ability
to record, process, summarize and report financial information;
and
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(b)
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Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
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September
14, 2007
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/s
/ Fredrick Cobb
Name:
Fredrick Cobb
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Title:
Vice President Finance, Principal Financial Officer
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(1)
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Fully
complies with the requirements of section 13 or 15 (d) of the Securities
Exchange Act of 1934; and
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(2)
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Fairly
presents, in all material respects, the financial condition and result
of
operations of the Company.
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September
14, 2007
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/s/ Thomas
Moore
Thomas
Moore
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Chief
Executive Officer
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(1)
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Fully
complies with the requirements of section 13 or 15 (d) of the Securities
Exchange Act of 1934; and
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(2)
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Fairly
presents, in all material respects, the financial condition and result
of
operations of the Company.
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September
14, 2007
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/s/ Fredrick
Cobb
Fredrick
Cobb
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Vice
President Finance, Principal Financial Officer
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