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OMB
APPROVAL
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OMB
Number: 3235-0416
Expires:
January 31, 2007
Estimated
Average burden
Hours
per response
136
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x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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Delaware
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841521955
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification No.)
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Page
No.
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|||
PART
I - FINANCIAL INFORMATION
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|||
Item
1. Condensed Financial Statements
|
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|||
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|||
Balance
Sheet at April 30, 2007 (unaudited)
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3
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|||
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|||
Statements
of Operations for the three and six month periods ended April 30,
2007 and
2006 (unaudited), and the period March 1, 2002 (inception) to
April 30, 2007 (unaudited)
|
4
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|||
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|||
Statement
of Cash Flows Statements for the six month periods ended April 30,
2007
and 2006 and the period March 1, 2002 (inception) to April 30, 2007
(unaudited)
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5
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|||
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|||
Notes
to Condensed Financial Statements
|
7
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|||
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|||
Item
2. Management’s Discussion and Analysis
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12
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|||
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|||
Item
3. Controls and Procedures
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16
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|||
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PART
II - OTHER INFORMATION
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|||
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|||
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
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16
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|||
Item
6. Exhibits and Reports on Form 8-K
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17
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|||
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SIGNATURES
|
18
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|||
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|||
CERTIFICATIONS
|
|
April
30,
2007
|
|||
ASSETS
|
||||
Current
Assets:
|
||||
Cash
|
$
|
889,397
|
||
Prepaid
expenses
|
49,880
|
|||
Total Current Assets
|
939,277
|
|||
|
||||
Property
and Equipment (net of accumulated depreciation of $39,070)
|
128,566
|
|||
Intangible
Assets (net of accumulated amortization of $123,433)
|
813,967
|
|||
Deferred
Financing Costs (net of accumulated amortization of
$162,285)
|
97,715
|
|||
Other
Assets
|
3,875
|
|||
|
||||
Total
Assets
|
1,983,400
|
|||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
604,818
|
|||
Accrued
expenses
|
490,474
|
|||
Notes
payable - current portion
|
72,704
|
|||
Total
Current Liabilities
|
1,167,996
|
|||
|
||||
Interest
payable
|
194,408
|
|||
Notes
payable - net of current portion
|
115,125
|
|||
Convertible
Secured Debentures and fair value of embedded derivative
|
4,559,669
|
|||
Common
Stock Warrants
|
1,215,150
|
|||
Total
Liabilities
|
7,252,348
|
|||
|
||||
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 45,677,046 shares
|
45,677 | |||
Additional
Paid-In Capital
|
7,520,122
|
|||
Deficit
accumulated during the development stage
|
(12,834,747
|
) | ||
Total
Shareholders' Deficiency
|
(5,268,948
|
) | ||
Total
Liabilities and Shareholders’ Deficiency
|
$
|
1,983,400
|
3
Months Ended April 30,
2007 |
3
Months Ended April 30,
2006 |
6
Months Ended April 30,
2007 |
6
Months Ended April 30,
2006 |
Period
from
March
1, 2002 (Inception) to
April
30,
2007 |
||||||||||||
Revenue
|
$
|
7,894
|
$
|
67,384
|
$
|
154,201
|
$
|
397,312
|
$
|
1,259,436
|
||||||
|
||||||||||||||||
Research
& Development Expenses
|
530,492
|
450,826
|
1,024,599
|
835,933
|
4,272,647
|
|||||||||||
General
& Administrative Expenses
|
1,002,829
|
603,688
|
1,847,901
|
1,017,571
|
6,191,694
|
|||||||||||
Total
Operating expenses
|
1,533,321
|
1,054,514
|
2,872,500
|
1,853,504
|
10,464,341
|
|||||||||||
Loss
from Operations
|
(1,525,427
|
)
|
(987,130
|
)
|
(2,718,299
|
)
|
(1,456,192
|
)
|
(9,204,905
|
)
|
||||||
Other
Income (expense):
|
||||||||||||||||
Interest
expense
|
(212,181
|
)
|
(113,001
|
)
|
(365,536
|
)
|
(114,009
|
)
|
(831,563
|
)
|
||||||
Other
Income
|
11,646
|
23,431
|
37,972
|
35,362
|
174,394
|
|||||||||||
Gain on note retirement | 319,967 | 319,967 | 319,967 | |||||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
(1,729,549
|
)
|
(229,923
|
)
|
(446,678
|
) |
(229,923
|
)
|
(3,248,756
|
)
|
||||||
Net
loss
|
(3,135,544
|
)
|
(1,306,623
|
)
|
(3,172,574
|
)
|
(1,764,762
|
)
|
(12,790,863
|
)
|
||||||
|
||||||||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
43,884
|
|||||||||||
|
||||||||||||||||
Net
loss applicable to Common Stock
|
$
|
(3,135,544
|
)
|
$
|
(1,306,623
|
)
|
$
|
(3,172,574
|
)
|
$
|
(1,764,762
|
)
|
$
|
(12,834,749
|
)
|
|
|
||||||||||||||||
Net
loss per share, basic and diluted
|
$
|
(0.07
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.05
|
)
|
||||
Weighted
average number of shares outstanding basic and diluted
|
43,714,807
|
38,259,006
|
42,385,001
|
38,000,975
|
6
Months ended
April
30,
|
|
|
6
Months ended
April
30,
|
|
|
Period
from March 1, 2002 (Inception) to April 30,
|
|
|||
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(3,172,574
|
)
|
$
|
(1,764,762
|
)
|
$
|
(12,790,864
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
net cash used in operating activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
999,931
|
275,536
|
1,711,141
|
|||||||
Amortization
of deferred financing costs
|
79,972
|
17,042
|
162,285
|
|||||||
Non-cash
interest expense
|
206,681
|
60,651
|
436,899
|
|||||||
Accrued
interest on notes payable
|
76,457
|
36,257
|
212,699
|
|||||||
Loss
on change in value of warrants and embedded derivative
|
446,678
|
|
229,923
|
3,248,756
|
||||||
Value
of penalty shares issued
|
-
|
-
|
117,498
|
|||||||
Depreciation
expense
|
14,629
|
8,289
|
39,070
|
|||||||
Amortization
expense of intangibles
|
28,878
|
|
20,719
|
126,604
|
||||||
Gain
on note retirement
|
(319,967
|
) |
-
|
(319,967
|
) | |||||
Decrease
(increase) in prepaid expenses
|
(11,780
|
)
|
(28,862
|
)
|
(49,880
|
)
|
||||
Decrease
(increase) in other assets
|
725
|
(2,090
|
)
|
(3,874
|
)
|
|||||
Increase
(decrease) in accounts payable
|
(83,403
|
) |
(45,309
|
)
|
1,042,024
|
|||||
Decrease
(increase) in accrued expenses
|
(31,993
|
)
|
214,777
|
474,285
|
||||||
Increase
(decrease) in deferred revenue
|
(20,350
|
)
|
-
|
-
|
||||||
Net
cash used in operating activities
|
(1,786,116
|
)
|
(977,829
|
)
|
(5,593,324
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(32,873
|
)
|
(5,072
|
)
|
(122,056
|
)
|
||||
Cost
of intangible assets
|
(48,469
|
)
|
(64,060
|
)
|
(1,015,523
|
)
|
||||
Net
cash used in investing Activities
|
(81,342
|
)
|
(69,132
|
)
|
(1,182,519
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
-
|
3,000,000
|
3,000,000
|
|||||||
Cash
paid for deferred financing costs
|
-
|
(260,000
|
)
|
(260,000
|
)
|
|||||
Payment
on notes payable
|
(4,311
|
)
|
-
|
(4,311
|
)
|
|||||
Proceeds
from notes payable
|
-
|
-
|
671,224
|
|||||||
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
|
(4,311
|
)
|
2,740,000
|
7,665,240
|
||||||
Net
(Decrease) increase in cash
|
(1,871,769
|
)
|
1,693,039
|
889,397
|
||||||
Cash
at beginning of period
|
2,761,166
|
2,075,206
|
||||||||
Cash
at end of period
|
$ |
889,397
|
$
|
3,768,245
|
$ |
889,397
|
6
Months ended
April
30,
|
|
|
6
Months ended
April
30,
|
|
|
Period
from March 1, 2002
(Inception)
to
|
|
|||
|
|
|
2007
|
|
|
2006
|
|
|
April
30, 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
|
$
|
610,836
|
-
|
$
|
1,523,994
|
|||||
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
|
1. |
Business
description
|
|
October
31, 2006
|
April
30, 2007
|
Increase/Decrease
|
|||||||
Trademark
|
$
|
74,948
|
$
|
84,299
|
$
|
9,351
|
||||
License
|
485,123
|
496,127
|
11,004
|
|
||||||
Patents
|
490,893
|
356,973
|
(133,920
|
)
|
||||||
Total
intangibles
|
1,050,964
|
937,399
|
(113,565
|
)
|
||||||
Accumulated
Amortization
|
(94,555
|
)
|
(123,433
|
)
|
(28,878
|
)
|
||||
Intangible
Assets
|
$
|
956,409
|
$
|
813,966
|
$
|
(142,443
|
)
|
|
April
30, 2007
|
|||
Warrants
|
25,009,220
|
|||
Stock
Options
|
8,512,841
|
|||
Convertible
Debt (1)
|
7,279,317
|
|||
Total
All
|
40,801,378
|
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 April 30,
2007
|
$
|
436,900
|
||
Conversion
of Debenture
|
$
|
(910,836
|
)
|
|
Convertible
Secured Debenture Liability as of April 30, 2007
|
$
|
1,798,249
|
||
Embedded
Derivative Liability
|
2,761,421
|
|||
Convertible
Secured Debentures and Fair Value of Embedded Derivative
Liability
|
$
|
4,559,670
|
Date
of
Conversion
|
Amount
of
Conversion
|
Number
of
Shares
|
Conversion
Share
Price
|
|||||||
February
1, 2007
|
$
|
25,000
|
166,445
|
$
|
.1502
|
|||||
March
5, 2007
|
$
|
50,000
|
343,407
|
$
|
.1456
|
|||||
March
29, 2007
|
$
|
250,000
|
1,717,033
|
$
|
.1456
|
|||||
April
24, 2007
|
$
|
135,836
|
827,763
|
$
|
.1641
|
|||||
Total
|
$
|
460,836
|
3,054,648
|
|||||||
Inception
to date
|
$
|
910,836
|
5,880,276
|
·
|
Clinical
trial expenses decreased $92,953, or 36%, to $162,493 from $255,446
due to
the start-up expenses of our clinical trial in the second quarter
of
Fiscal 2006.
|
·
|
Wages,
salaries and related costs increased $15,923, or 11%, to $154,986
from
$139,063 principally due to expanded research and development
staffing.
|
·
|
Subcontracted
and consulting expenses increased by $121,761, or 738%, to $138,261
from
$16,500, primarily due to:
|
- $79,697
higher stock option expenses due to the revaluation required under
the
FASB 123R due to increases in the FMV.
|
|
- $22,190
higher outside research cost
|
|
- $19,874
higher IND consulting expense for a planned FDA
submission.
|
|
·
|
Toxicology
study expenses increased $37,640 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
and benefit expenses increased by $117,546, or 151% to $195,385 from
$77,839 due to hiring key administrative staff in the second quarter
Fiscal 2006 and a Chief Executive Officer in December
2006.
|
·
|
Consulting
fees and expenses increased by $320,708, or 201%, to $480,157 from
$159,449. This increase was due to the revaluation of options granted
to
Mr. Appel, Director, in connection with services to be performed
by his
affiliate, (LVEP) resulting in an increase of $406,657 in option
expense
required under the FASB 123R due to increases in the FMV partially
offset
by his bonus accrual recorded in Fiscal 2006 Quarter that was not
required
in Fiscal 2007 Quarter and a reduction of $60,917 in other consulting
expense due to fewer consultants in Fiscal 2007
Quarter.
|
·
|
A
decrease in legal fees and investment banking fees of $38,790, or
27%, to
$103,484 from $142,274 primarily resulted from lesser delegation
to
outside counsel of tasks related to SEC filings.
|
·
|
Clinical
trial expenses increased $3,472, or 1%, to $284,957 in Fiscal 2007
from
$281,485 due to the start-up of our clinical trial which did not
commence
until the second quarter of Fiscal 2006.
|
·
|
Wages,
salaries and related costs increased $119,103, or 47%, to $371,759
in
Fiscal 2007 from $252,656 principally due to our expanded research
and
development staff and bonus accrual.
|
·
|
Subcontract
and consulting expenses increased by $53,485, or 28%, to $245,742
in
Fiscal 2007 from $192,256 the higher option expense and wages due
to
additional research staff and IND consulting partially offset by
the
reduced subcontract work performed by Dr. Paterson at
Penn.
|
·
|
Wages
and benefit expenses increased by $208,625, or $162% to $337,806
in Fiscal
2007 from $129,181 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 $564,862, or 138%, to $975,166 in
Fiscal
2007 from $410,304. 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 $566,566 of option expense
of
which $159,890 vested during Fiscal 2007, $406,676 due to revaluation
due
to changes in FMV, (ii) an increase of his bonus by $16,635; and
(iii)
$200,000 due to the issuance to him of 1,000,000 shares of common
stock of
the Company compared to $90,603 recorded in Fiscal 2006, partially
offset
by a reduction of $143,922 in other consulting
expenses.
|
Higher overall expenses of $94,338 for insurance costs of $21,709, option expenses of $23,696, depreciation and amortization expenses of $14,499 and overall operating expenses of $34,434. | |
A
decrease in legal expenses of $39,992, or 21%, to $151,013 from $191,005,
primarily the result of lesser delegation to outside counsel of tasks
related to SEC filings.
|
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
|
32.2
|
Certification
of Principal Financial Officer pursuant to section 906 of the
Sarbanes-Oxley Act of 2002
|
ADVAXIS,
INC.
Registrant
|
||
|
|
|
Date: June 14, 2007 | By: | /s/ Thomas Moore |
Thomas Moore |
||
Chief
Executive Officer and Chairman of the
Board
|
|
|
|
By: | /s/ Fredrick Cobb | |
Fredrick Cobb |
||
Vice
President Finance, Principal Financial
Officer
|