|
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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