x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
ADVAXIS, INC.
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
02-0563870
|
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
The Technology Centre of New Jersey, 675 Route 1,
Suite 119, North Brunswick, NJ 08902
|
(Address
of principal executive offices)
|
(732) 545-1590
|
(Registrant’s
telephone number)
|
|
(Former
name, former address and former fiscal year, if changed since last
report)
|
Large accelerated filer
¨
|
Accelerated filer
¨
|
Non-accelerated filer
¨
|
Smaller Reporting Company
x
|
Page
No.
|
||
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements
|
|
Balance
Sheet at April 30, 2010 (unaudited) and October 31, 2009
|
2
|
|
Statements
of Operations for the three and six month periods ended April 30, 2010 and
2009 and the period March 1, 2002 (inception) to April 30, 2010
(unaudited)
|
3
|
|
Statements
of Cash Flow for the six month periods ended April 30, 2010 and 2009 and
the period March 1, 2002 (inception) to April 30, 2010
(unaudited)
|
4
|
|
Supplemental
Schedule of Noncash Investing and Financing Schedules
|
5
|
|
Notes
to Financial Statements
|
6
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
21
|
Item
4T.
|
Controls
and Procedures
|
21
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
22
|
Item
1A.
|
Risk
Factors
|
22
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
22
|
Item
6.
|
Exhibits
|
22
|
SIGNATURES
|
23
|
April 30,
2010
|
October 31,
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 227,245 | $ | 659,822 | ||||
Prepaid
expenses
|
65,003 | 36,445 | ||||||
Total
Current Assets
|
292,248 | 696,267 | ||||||
Deferred
expenses
|
206,528 | 288,544 | ||||||
Property
and Equipment (net of accumulated depreciation)
|
45,439 | 54,499 | ||||||
Intangible
Assets (net of accumulated amortization)
|
1,486,336 | 1,371,638 | ||||||
Deferred
Financing Cost
|
- | 299,493 | ||||||
Other
Assets
|
20,685 | 3,876 | ||||||
Total
Assets
|
$ | 2,051,236 | $ | 2,714,317 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 1,782,895 | $ | 2,368,716 | ||||
Accrued
expenses
|
748,492 | 917,250 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
4,073,716 | 2,078,851 | ||||||
Notes
payable – including interest payable
|
940,653 | 1,121,094 | ||||||
Total
Current Liabilities
|
7,545,756 | 6,485,911 | ||||||
Common
Stock Warrant
|
16,467,800 | 11,961,734 | ||||||
Total
Liabilities
|
$ | 24,013,556 | $ | 18,447,645 | ||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; issued and
outstanding 361 at April 30, 2010 and 0 at October 31,
2009
|
||||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 142,781,243 at April 30, 2010 and 115,638,243 at October 31,
2009
|
142,780 | 115,638 | ||||||
Additional
Paid-In Capital
|
12,572,129 | 754,834 | ||||||
Stock
subscription receivable
|
(4,881,710 | ) | - | |||||
Deficit
accumulated during the development stage
|
(29,795,519 | ) | (16,603,800 | ) | ||||
Total
Shareholders' Deficiency
|
$ | (21,962,320 | ) | $ | (15,733,328 | ) | ||
Total
Liabilities and stockholders’ deficiency
|
$ | 2,051,236 | $ | 2,714,317 |
Three Months Ended
April 30,
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to
April 30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Revenue
|
$
|
87,234
|
$
|
$
|
87,234
|
$
|
$
|
1,442,096
|
||||||||||||
Research
& Development Expenses
|
1,084,703
|
283,812
|
2,082,038
|
462,986
|
12,255,579
|
|||||||||||||||
General
& Administrative Expenses
|
779,463
|
488,468
|
1,368,478
|
1,033,922
|
14,078,178
|
|||||||||||||||
Total
Operating expenses
|
1,864,166
|
772,280
|
3,450,516
|
1,496,908
|
26,333,757
|
|||||||||||||||
Loss
from Operations
|
(1,776,932
|
)
|
(772,280
|
)
|
(3,363,282
|
)
|
(1,496,908
|
)
|
(24,891,661
|
)
|
||||||||||
Other
Income (expense):
|
||||||||||||||||||||
Interest
expense
|
(1,647,069
|
)
|
(20,658
|
)
|
(3,313,208
|
)
|
(36,052
|
)
|
(5,248,699
|
)
|
||||||||||
Other
Income
|
14,539
|
-
|
16,810
|
-
|
263,267
|
|||||||||||||||
Gain
on note retirement
|
64,354
|
-
|
64,354
|
-
|
1,596,831
|
|||||||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
(5,785,257
|
)
|
-
|
(6,875,371
|
)
|
-
|
(2,672,374
|
)
|
||||||||||||
Net
(Loss) before benefit for income taxes
|
(9,130,365
|
)
|
(792,938
|
)
|
(13,470,697
|
)
|
(1,532,960
|
)
|
(30,952,636
|
)
|
||||||||||
Income
tax benefit
|
-
|
-
|
278,978
|
922,020
|
1,201,001
|
|||||||||||||||
Net
(Loss)
|
(9,130,365
|
)
|
(792,938
|
)
|
(13,191,719
|
)
|
(610,940
|
)
|
(29,751,635
|
)
|
||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
(43,884
|
)
|
||||||||||||||
Net
(Loss) applicable to Common Stock
|
$
|
(9,130,365
|
)
|
$
|
(792,938
|
)
|
$
|
(13,191,719
|
)
|
$
|
(610,940
|
)
|
$
|
(29,795,519
|
)
|
|||||
Net
(Loss) per share, basic
|
$
|
(.07
|
)
|
$
|
(0.01
|
)
|
$
|
(.11
|
)
|
$
|
(0.01
|
)
|
||||||||
Net
(Loss) per share, diluted
|
$
|
(.07
|
)
|
$
|
(0.01
|
)
|
$
|
(.11
|
)
|
$
|
(0.01
|
)
|
||||||||
Weighted
average number of shares outstanding, basic
|
133,124,164
|
112,319,454
|
125,577,856
|
111,255,809
|
||||||||||||||||
Weighted
average number of shares, diluted
|
133,124,164
|
112,319,454
|
125,577,856
|
111,255,809
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to
April 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$
|
(13,191,719
|
)
|
$
|
(610,940
|
)
|
$
|
(29,751,635
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in
|
||||||||||||
operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and
stock
|
268,696
|
94,943
|
2,693,451
|
|||||||||
Amortization
of deferred financing costs
|
-
|
-
|
260,000
|
|||||||||
Amortization
of deferred expenses
|
82,016
|
-
|
143,472
|
|||||||||
Amortization
of discount on Bridge Loans
|
480,730
|
604,576
|
||||||||||
Impairment
of intangible assets
|
-
|
26,087
|
||||||||||
Non-cash
interest expense
|
2,818,711
|
31,676
|
4,035,547
|
|||||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
6,875,371
|
-
|
2,672,374
|
|||||||||
Value
of penalty shares issued
|
-
|
-
|
149,276
|
|||||||||
Depreciation
expense
|
19,075
|
18,324
|
147,813
|
|||||||||
Amortization
expense of intangibles
|
43,522
|
35,434
|
405,454
|
|||||||||
Gain
on note retirement
|
(64,354
|
)
|
(1,596,831
|
)
|
||||||||
Decrease
(Increase) in prepaid expenses
|
(28,558
|
) |
(13,520
|
)
|
(65,002
|
)
|
||||||
Increase
in other assets
|
(14,538
|
)
|
-
|
(18,415
|
)
|
|||||||
(Decrease)
increase in accounts payable
|
(460,987
|
)
|
107,250
|
2,396,912
|
||||||||
(Decrease)
Increase in accrued expenses
|
(168,758
|
)
|
(18,825
|
308,860
|
||||||||
(Decrease)
in interest payable
|
(161,200
|
)
|
-
|
(142,909
|
)
|
|||||||
Net
cash used in operating activities
|
(3,501,993
|
)
|
(355,658
|
)
|
(17,730,970
|
)
|
||||||
INVESTING ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
(44,940
|
)
|
|||||||||
Purchase
of property and equipment
|
(10,014
|
)
|
-
|
(147,671
|
)
|
|||||||
Cost
of intangible assets
|
(158,220
|
)
|
(117,764
|
)
|
(1,992,829
|
)
|
||||||
Net
cash used in Investing Activities
|
(168,234
|
)
|
(117,764
|
)
|
(2,185,440
|
)
|
||||||
FINANCING ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
-
|
960,000
|
||||||||||
Cash
paid for deferred financing costs
|
-
|
-
|
(559,493
|
)
|
||||||||
Principal
payment on notes payable
|
(1,150,177
|
)
|
(4,813
|
)
|
(1,273,768
|
)
|
||||||
Proceeds
from notes payable
|
1,015,000
|
-
|
6,020,859
|
|||||||||
Payment
on notes payable
|
-
|
449,985
|
||||||||||
Net
proceeds of issuance of Preferred Stock
|
3,202,827
|
-
|
3,437,827
|
|||||||||
Cancellation
of warrants
|
-
|
-
|
(600,000
|
)
|
||||||||
Proceeds
from exercise of warrants
|
170,000
|
170,000
|
||||||||||
Proceeds
from issuance of common stock
|
-
|
-
|
11,988,230
|
|||||||||
Net
cash provided by financing Activities
|
3,237,650
|
445,172
|
20,143,655
|
|||||||||
Net
(Decrease) increase in cash
|
(432,577
|
)
|
(28,250
|
)
|
227,245
|
|||||||
Cash
at beginning of period
|
659,822
|
59,738
|
-
|
|||||||||
Cash
at end of period
|
$
|
227,245
|
$
|
31,488
|
$
|
227,245
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to April
30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Equipment
acquired under capital lease
|
- | - | $ | 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 | ||||||||
Accounts
payable from consultants settled with Common Stock
|
- | $ | 51,978 | $ | 51,978 | |||||||
Notes
payable and accrued interest converted to Common Stock
|
- | - | $ | 2,513,158 | ||||||||
Intangible
assets acquired with notes payable
|
- | - | $ | 360,000 | ||||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$ | 539,354 | - | $ | 2,621,796 | |||||||
Allocation
of the original secured convertible debentures to warrants
|
- | - | $ | 214,950 | ||||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$ | 639,735 | - | $ | 1,580,246 | |||||||
Note
receivable in connection with exercise of warrants
|
$ | 4,881,710 | - | $ | 4,881,710 | |||||||
Warrants
Issued in connection with issuance of Common Stock
|
- | - | $ | 1,505,550 | ||||||||
Warrants
issued in connection with issuances of Preferred stock
|
- | - | $ | 3,587,625 |
April 30,
2010
|
October 31,
2009
|
|||||||
License
|
$
|
651,992
|
$
|
571,275
|
||||
Patents
|
1,157,802
|
1,080,299
|
||||||
Total
intangibles
|
1,809,794
|
1,651,574
|
||||||
Accumulated
Amortization
|
(323,458
|
)
|
(279,936
|
)
|
||||
Intangible
Assets
|
$
|
1,486,336
|
$
|
1,371,638
|
Bridge
Note – Principal Value - Issued
|
$ |
4,474,601
|
||
Principal
payments on Bridge Notes
|
(1,040,177
|
)
|
||
Original
Issue Discount, net of accreted interest
|
(68,375
|
)
|
||
Fair
Value of Attached Warrants at issuance
|
(1,580,248)
|
|||
Fair
Value of Embedded Derivatives at issuance
|
(2,430,858
|
)
|
||
Accreted
interest on embedded derivative and warrant liabilities
|
3,641,114
|
|||
Convertible
Bridge Notes- as of April 30, 2010
|
$
|
2,996,057
|
||
Embedded
Derivatives Liability at April 30, 2010
|
1,077,659
|
|||
Convertible Bridge
Notes and fair value of embedded derivative
|
$
|
4,073,716
|
Description
|
Principal
|
Original
Issue
Discount
|
Warrant
Liability
|
Embedded
Derivative
Liability
|
||||||||||||
Bridge
Note I-June 18, 2009
|
$
|
1,131,353
|
$
|
169,703
|
$
|
250,392
|
$
|
711,258
|
||||||||
Bridge
Note II & III-October 26 & 30, 2009
|
2,147,059
|
322,059
|
690,119
|
868,388
|
||||||||||||
Optimus
September 24, 2009
|
-
|
-
|
3,587,625
|
-
|
||||||||||||
Other
outstanding warrants
|
-
|
-
|
12,785,695
|
-
|
||||||||||||
Total
Valuation at Origination
|
$
|
3,278,412
|
$
|
491,762
|
$
|
17,313,831
|
$
|
1,579,646
|
||||||||
Change
in fair value
|
-
|
-
|
(5,352,097
|
)
|
(493,132
|
)
|
||||||||||
Accreted
interest
|
-
|
(123,846
|
)
|
-
|
-
|
|||||||||||
Total
Valuation as of October 31, 2009
|
$
|
3,278,412
|
$
|
367,916
|
$
|
11,961,734
|
$
|
1,086,514
|
||||||||
Bridge
Notes IV – December 1, 2009 through January 31, 2010
|
555,882
|
83,382
|
207,617
|
164,400
|
||||||||||||
Bridge
Note I- Extension of Maturity Date
|
202,500
|
103,400
|
||||||||||||||
Change
in fair value
|
1,995,372
|
(905,259)
|
||||||||||||||
Accreted interest
|
(225,321)
|
|||||||||||||||
Exercise
of Common Stock Warrants
|
(1,702,073)
|
|||||||||||||||
Total Valuation
as of January 31, 2010
|
$
|
3,834,294
|
$
|
225,977
|
$
|
12,665,150
|
$
|
449,055
|
||||||||
Bridge
Note V
|
640,307
|
97,807
|
229,619
|
271,554
|
||||||||||||
Change
in fair value
|
5,363,854
|
421,404
|
||||||||||||||
Accreted
interest
|
(251,188
|
)
|
||||||||||||||
Exercise
of common stock warrants
|
(1,790,823
|
)
|
||||||||||||||
Note
Payoffs
|
(1,040,177
|
)
|
(4,222
|
)
|
(64,354
|
)
|
||||||||||
Total
Valuation as of April 30, 2010
|
$
|
3,434,424
|
$
|
68,374
|
$
|
16,467,800
|
$
|
1,077,659
|
As of April 30,
|
||||||||
2010
|
2009
|
|||||||
Research
and development
|
$
|
29,042
|
$
|
31,074
|
||||
General
and Administrative
|
61,225
|
45,692
|
||||||
Total
stock compensation expense recognized
|
$
|
90,267
|
$
|
76,766
|
|
·
|
Clinical trial expenses increased
by $750,511, to $751,242 from $731, due to our clinical trial activity
initiated during the first fiscal quarter of
2010.
|
|
·
|
Wages, including stock-based
compensation approximately $64,000, or 28% to $291,649 from $227,456,
primarily as a result of increased salaries (including an executive bonus)
and increased stock-based compensation resulting from the 2009 stock
option plan.
|
|
·
|
Legal expenses increased
approximately $16,000, which was more than offset by consulting costs
which decreased by about
$27,000.
|
|
·
|
Salaries and employee benefits
increased by approximately $170,000, or 90% to $357,785 from $188,094 a
year ago, due to higher salaries and health insurance
premiums.
|
|
·
|
Stock-based
compensation increased by $40,629, to $50,028 from $9,399 a year ago, due
to the issuance of new options under the 2009 stock option
plan.
|
|
·
|
Legal
and accounting fees increased by $125,226, to $180,675 from $55,449,
primarily as a result of increased legal fees of $83,634
and increased accounting fees of $41,492, which were more than offset
by a decrease in offering expenses of $47,393 due to the application of
financing costs to additional paid-in
capital.
|
|
·
|
Clinical trial expenses increased
by $1,482,907, to $1,484,676 from $1,769, primarily due to our clinical
trial activity initiated during the first fiscal quarter of
2010.
|
|
·
|
Salaries, including stock-based
compensation, increased by approximately $70,000, primarily as a result of
increased stock-based compensation expense and salaries. Additionally, in
the six months ended April 30, 2009, a bonus accrual was reversed,
lowering expenses by approximately $122,000 in that
period.
|
|
·
|
Consulting expenses decreased by
$49,960, or 92%, to $4,500 from $54,460, due to a decline in the number of
consultants utilized by Advaxis and no stock-based compensation compared
to a year ago.
|
|
·
|
Salaries
and related expenses increased by approximately $144,000, or 35% to
$556,123 from $411,653 due to wages and benefits increasing by
approximately $119,000 from higher salaries and increased health insurance
premiums partially offset by lower 401K expenses of approximately $9,000.
Additionally, in the six months ended April 30, 2009, a bonus accrual was
reversed, lowering expenses by approximately $36,000 in that
period.
|
|
·
|
Stock-based compensation
increased $112,181, to $157,873 from $45,692 a year ago, due to the
issuance of new options under the 2009 stock option
plan.
|
|
·
|
Legal and accounting fees
increased by approximately $190,000, primarily as a result of higher legal
fees of approximately $148,000 and higher accounting fees of approximately
$43,000 due to increased utilization of temporary professionals and
outside auditor fees in the Fiscal 2010, which were more than offset by a
decrease in offering expenses of approximately $142,000 due to the
application of financing costs to additional paid-in
capital.
|
|
·
|
Patent expenses decreased
approximately $77,000 due to lower amounts paid to University of
Pennsylvania under our licensing agreement, offset by higher regulatory
costs of approximately
$10,000.
|
|
·
|
It requires assumptions to be
made that were uncertain at the time the estimate was made,
and
|
|
·
|
Changes in the estimate of
difference estimates that could have been selected could have an material
impact on our results of operations or financial
condition.
|
10.1
|
Second
Amendment to the Amended and Restated Patent License Agreement between the
registrant and the University of Pennsylvania dated as of May 10,
2010
|
|
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
|
ADVAXIS, INC.
Registrant
|
||
Date: June 1, 2010
|
By:
|
/s/ Thomas Moore
|
Thomas Moore
Chief Executive Officer and Chairman of the Board
|
||
By:
|
/s/ Mark J. Rosenblum
|
|
Mark J. Rosenblum
Chief Financial Officer, Senior Vice President and Secretary
|
1)
|
Attachment
1- List of Intellectual Property is deleted in its entirety and replaced
with Exhibit 1 to this Second Amendment, which includes the Additional
Penn Dockets.
|
2)
|
On
the Effective Date of this Second Amendment Company shall pay to Penn,
solely at Penn’s option, i) a non-refundable, non-assessable option
exercise fee of $10,000 per Additional Docket ($70,000 total) in cash or
ii) $140,000 in stock, or iii) a mix of cash and stock of which the stock
component will be no less than twenty-five percent (25%) of the
total. The number of shares of stock to be issue to Penn will
be calculated as follows: the percentage of the option exercise fee to be
paid in stock multiplied by $140,000. The product of that calculation is
then divided by the price per share of the most recently completed
financing round to determine the number of shares of stock to be issued to
Penn. Penn will be entitled to receive the same class of shares as the
most recent round of financing. The issuance to Penn will entitle Penn to
the same rights, preferences, warrant and/or option coverage, conversion
privileges, etc. as granted to the participants in the most recent round
of financing.
|
3)
|
Company
agrees to reimburse Penn for all outstanding expenses, associated with the
Agreement and the First Amendment and the Sponsored Research Agreement
(“SRA”), by wire transfer of immediately available funds, as
follows:
|
a)
|
Sixty-five
thousand dollars ($65,000) on or before the first day of each month
beginning May 1, 2010 and ending on September 1, 2010, inclusive. And
fifty-four thousand seventy-nine dollars ($54,079) on or before September
30, 2010.
|
4)
|
Company
agrees to pay all historical patent expenses associated with this Second
Amendment that adds Additional Dockets. These expenses include, but are
not limited to, all historically accrued patent and licensing expenses,
attorney’s fees, official fees and all other charges incident to the
preparation, prosecution and maintenance of the Penn Patent Rights that
were incurred and docketed by Penn relating to the Additional Penn Dockets
on or before the Effective Date of this Second
Amendment. Company shall pay such expenses to Penn, in cash, in
the following amounts:
|
|
a)
|
at
least twenty percent (20%) of any amount of funding raised on or after
April 1, 2010 (whether or not the funding has been drawn), regardless of
the form. Such payments will be paid to Penn within ten (10) days after
the completion of each tranche of funding regardless of the form of the
funding or the type of security and regardless of whether Company has
drawn down funds. Notwithstanding the foregoing, Company is not precluded
from paying a higher percentage of funding raised towards these
obligations or paying the obligations in full at any
time.
|
5)
|
This
section reaffirms Company’s obligations to reimburse Penn for all
documented attorneys fees, expenses, official fees and other charges
incident to the preparation, prosecution, maintenance and licensing of
Penn Patent Rights pursuant to the terms of the Agreement, as
amended.
|
6)
|
Except
as specifically modified or amended hereby, the Agreement, as amended by
the First Amendment, shall remain in full force and
effect.
|
7)
|
No
provision of this Amendment may be modified or amended except expressly in
a writing signed by all parties nor shall any term be waived except
expressly in a writing signed by the party charged
therewith.
|
8)
|
This
Second Amendment may be executed in two or more counterparts, each of
which shall be deemed an original but all of which taken constitute one
and the same
instrument.
|
THE
TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
|
||
By:
|
/s/ Michael J. Cleare, PhD | |
Name: Michael
J. Cleare, PhD
|
||
Title: Executive
Director
|
||
Date:
|
5/11/2010 | |
ADVAXIS,
INC.
|
||
By:
|
/s/ Thomas A. Moore | |
Name:
|
Thomas A. Moore | |
Title:
|
Chairman and CEO | |
Date:
|
May 7, 2010 |
D751
|
Live, Recombinant Listeria
Monocytogenes Vaccines and Production of Cytotoxic T-Cell
Response
|
H1219
|
Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine
Vector
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
2,204,666
|
Canada
|
11/03/1995
|
National
Phase
|
Filed
|
||
PCT/US1995/014741
|
World Patent
Org
|
11/03/1995
|
PCT
|
Expired
|
||
2007-125462
|
Japan
|
05/10/2007
|
National
Phase
|
Filed
|
||
95939926.2
|
0790835
|
Switzerland
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
United
Kingdom
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
Belgium
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
Ireland
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
Germany
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
France
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
Liechtenstein
|
08/04/2004
|
11/03/1995
|
EPO
|
Issued
|
95939926.2
|
0790835
|
European Patent
Office
|
08/04/2004
|
11/03/1995
|
National
Phase
|
Issued
|
515534/96
|
3995712
|
Japan
|
08/10/2007
|
11/03/1995
|
National
Phase
|
Filed
|
08/336,372
|
6,051,237
|
United
States
|
04/18/2000
|
11/08/1994
|
Utility
|
Issued
|
10/441,851
|
7,135,188
|
United
States
|
11/14/2006
|
05/20/2003
|
Continuation
|
Filed
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
09/535,212
|
6,565,852
|
United
States
|
05/20/2003
|
03/27/2000
|
CIP
|
Issued
|
J1598
|
Immunogenic Compositions
Comprising DAL/DAT Double Mutant, Auxotrophic Attenuated
Strains of Listeria and Their
Methods of
Use
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
12/216,806
|
United
States
|
07/10/2008
|
Continuation
|
Filed
|
||
98957980.0
|
Germany
|
11/13/1998
|
EPO
|
Issued
|
||
98957980.0
|
United
Kingdom
|
11/13/1998
|
EPO
|
Issued
|
||
98957980.0
|
France
|
11/13/1998
|
EPO
|
Issued
|
||
2,309,790
|
05083948
|
Canada
|
07/06/2000
|
11/13/1998
|
National
Phase
|
Filed
|
98957980.0
|
1032417
|
European Patent
Office
|
6-Jan-10
|
11/13/1998
|
National
Phase
|
Issued
|
08/972,902
|
6,099,848
|
United
States
|
08/08/2000
|
11/18/1997
|
Utility
|
Issued
|
14108/99
|
730296
|
Australia
|
13-Nov-98
|
11/13/1998
|
National
Phase
|
Issued
|
Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of $I(Listeria) Expressing
Heterologous
Antigens
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
PCT/US1998/024357
|
World Patent
Org
|
11/13/1998
|
PCT
|
Expired
|
A Bacterial Vaccine Vector and
Methods of Use Thereof
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
10/660,194
|
7,488,487
|
United
States
|
02/10/2009
|
09/11/2003
|
Continuation
|
Issued
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
09/520,207
|
6,504,020
|
United
States
|
01/07/2003
|
03/07/2000
|
Divisional
|
Issued
|
10/136,253
|
6,635,749
|
United
States
|
10/21/2003
|
05/01/2002
|
Divisional
|
Issued
|
L2134
|
Compositions, Methods and Kits for
Enhancing the Immunogenicity of a Bacterial Vaccine
Vector
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
151942
|
151942
|
Israel
|
10/21/2009
|
03/26/2001
|
National
Phase
|
Issued
|
2,404,164
|
Canada
|
National
Phase
|
Abandoned
|
|||
01928324.1
|
European Patent
Office
|
03/26/2001
|
EPO
|
Filed
|
||
01928324.1
|
Germany
|
03/26/2001
|
EPO
|
In
Preparation
|
||
01928324.1
|
France
|
03/26/2001
|
EPO
|
In
Preparation
|
||
2001-570290
|
Japan
|
03/26/2001
|
National
Phase
|
Filed
|
||
01928324.1
|
United
Kingdom
|
03/26/2001
|
EPO
|
In
Preparation
|
||
PCT/US2001/009736
|
World Patent
Org
|
03/25/2001
|
PCT
|
Expired
|
||
09/735,450
|
6,767,542
|
United
States
|
07/27/2004
|
12/13/2000
|
CIP
|
Issued
|
Fusion of Non-hemolytic, Truncated
Form of Listeriolysin O to Antigens to Enhance
Immunogenicity
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
10/239,703
|
7,635,479
|
United
States
|
12/22/2009
|
03/26/2001
|
National
Phase
|
Issued
|
11/376,572
|
United
States
|
03/16/2006
|
Divisional
|
Filed
|
||
11/376,564
|
United
States
|
03/16/2006
|
Divisional
|
Filed
|
||
09/537,642
|
6,855,320
|
United
States
|
02/15/2005
|
03/29/2000
|
Utility
|
Issued
|
10/835,662
|
7,588,930
|
United
States
|
09/15/2009
|
04/30/2004
|
CIP
|
Issued
|
O2876
|
Compositions and Methods for
Enhancing the Immunogenicity of
Antigens
|
Q3610
|
Antibiotic Resistance Free DNA
Vaccines
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
60/601,493
|
United
States
|
08/13/2004
|
Provisional
|
Expired
|
||
05810446.4
|
European Patent
Office
|
08/15/2005
|
EPO
|
Filed
|
||
2,577,270
|
Canada
|
08/15/2005
|
National
Phase
|
Filed
|
||
11/203,408
|
United
States
|
08/15/2005
|
Utility
|
Filed
|
||
2005271247
|
Australia
|
08/15/2005
|
National
Phase
|
Abandoned
|
||
PCT/US2005/028896
|
World Patent
Org
|
08/15/2005
|
PCT
|
Expired
|
||
2007-525862
|
Japan
|
08/15/2005
|
National
Phase
|
Filed
|
Q3614
|
Methods for Constructing
Antibiotic Resistance Free
Vaccines
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
11/203,415
|
United
States
|
08/15/2005
|
Utility
|
Filed
|
||
11/785,249
|
United
States
|
04/16/2007
|
CIP
|
Filed
|
||
11/818,965
|
United
States
|
04/27/2007
|
CIP
|
Filed
|
||
2,577,306
|
Canada
|
08/15/2005
|
National
Phase
|
Filed
|
||
05808671.1
|
European Patent
Office
|
08/15/2005
|
EPO
|
Filed
|
||
PCT/US2005/028895
|
World Patent
Org
|
08/15/2005
|
PCT
|
Expired
|
||
2007-525861
|
Japan
|
08/15/2005
|
National
Phase
|
Filed
|
||
60/601,492
|
United
States
|
08/13/2004
|
Provisional
|
Expired
|
||
2005271246
|
Australia
|
08/15/2005
|
National
Phase
|
Abandoned
|
||
PCT/US08/04861
|
World Patent
Org
|
04/15/2008
|
PCT
|
Expired
|
||
TBD
|
Japan
|
04/15/2008
|
National
Phase
|
In
Preparation
|
||
60/924,033
|
United
States
|
04/27/2007
|
Provisional
|
Unknown
|
||
08742912.2
|
European Patent
Office
|
04/15/2008
|
National
Phase
|
Filed
|
R3702
|
Listeria-Based and Llo-Based
Vaccines
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
05811815.9
|
European Patent
Office
|
09/14/2005
|
EPO
|
Filed
|
||
2005289957
|
Australia
|
09/14/2005
|
National
Phase
|
Abandoned
|
||
2007-533537
|
Japan
|
09/14/2005
|
National
Phase
|
Filed
|
||
2,581,331
|
Canada
|
09/14/2005
|
National
Phase
|
Filed
|
||
PCT/US2005/032682
|
World Patent
Org
|
09/14/2005
|
PCT
|
Expired
|
||
10/949,667
|
United
States
|
09/24/2004
|
CIP
|
Filed
|
||
PCT/US06/43987
|
World Patent
Org
|
11/13/2006
|
PCT
|
Expired
|
||
60/735,184
|
United
States
|
11/10/2005
|
Provisional
|
Expired
|
||
12/084,829
|
United
States
|
11/13/2006
|
National
Phase
|
Abandoned
|
||
11/223,945
|
United
States
|
09/13/2005
|
CIP
|
Filed
|
S4225
|
Compositions and Methods for
Enhancing the Immunogenicity of
Antigens
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
08726578.1
|
European Patent
Office
|
03/07/2008
|
EPO
|
Filed
|
||
PCT/US2008/03067
|
United
States
|
03/07/2008
|
PCT
|
Expired
|
||
TBD
|
Japan
|
03/07/2008
|
National
Phase
|
Filed
|
||
PCT/US2007/10635
|
World Patent
Org
|
05/02/2007
|
PCT
|
Expired
|
||
11/715,497
|
United
States
|
03/08/2007
|
CIP
|
Filed
|
||
11/415,271
|
United
States
|
05/02/2006
|
CIP
|
Filed
|
S4243
|
Methods and Compositions for
Treating IgE-Mediated
Diseases
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
2009-523812
|
Japan
|
08/06/2007
|
National
Phase
|
Filed
|
||
11/882,782
|
United
States
|
08/06/2007
|
Utility
|
Abandoned
|
||
60/835,420
|
United
States
|
08/04/2006
|
Provisional
|
Expired
|
||
PCT/US2007/017479
|
World Patent
Org
|
08/06/2007
|
PCT
|
Expired
|
||
078111120.0
|
European Patent
Office
|
08/06/2007
|
National
Phase
|
Filed
|
U4810
|
A
listeria monocytogenes-based bacterial vaccine vector expressing mouse
VEGFR2/Flk-1 for cancer
therapy
|
Serial No.
|
Patent No.
|
Country
|
Issue Date
|
File Date
|
App Type
|
Status
|
61/157,367
|
United
States
|
3/4/2009
|
Provisional
|
Filed
|
1.
|
I have reviewed this report on
Form 10-Q for the quarter ended April 30, 2010 of Advaxis,
Inc.;
|
2.
|
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;
|
3.
|
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 registrant as of, and for, the
periods presented in this
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 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
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
|
|
(d)
|
Disclosed in this 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.
|
June
1, 2010
|
/s/ Thomas
Moore
|
Name:
Thomas Moore
|
Title:
Chief Executive Officer
|
1.
|
I have reviewed this report on
Form 10-Q for the quarter ended April 30, 2010 of Advaxis,
Inc.;
|
2.
|
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;
|
3.
|
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 registrant as of, and for, the
periods presented in this
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)7 and
15d-15(e)7 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 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
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
|
|
(d)
|
Disclosed in this 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.
|
June1,
2010
|
/s
/ Mark J. Rosenblum
|
Name:
Mark J. Rosenblum
|
Title:
Chief Financial Officer
|
(1)
|
Fully complies with the
requirements of section 13(a) or 15(d) of the Securities Exchange Act
of 1934, as amended; and
|
(2)
|
Fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
June
1, 2010
|
/s/ Thomas
Moore
|
Thomas
Moore
|
Chief
Executive Officer
|
(1)
|
Fully complies with the
requirements of section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended; and
|
(2)
|
Fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
June
1, 2010
|
/s/ Mark
J. Rosenblum
|
Mark
J. Rosenblum
|
Chief
Financial Officer
|