x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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ADVAXIS,
INC.
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(Exact
name of small business issuer as specified in its
charter)
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Delaware
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02-0563870
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification
No.)
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The
Technology Centre of New Jersey, 675 Route 1, Suite 119, North Brunswick,
NJ 08902
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(Address
of principal executive
offices)
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(732)
545-1590
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(Issuer’s
telephone number)
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(Former
name, former address and former fiscal year, if changed since last
report)
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Large accelerated filer
o
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Accelerated
filer o
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Non-accelerated filer
o
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Smaller Reporting Company
x
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Page
No.
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PART
I
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FINANCIAL
INFORMATION
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Item
1.
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Financial
Statements
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Balance
Sheet at January 31, 2009 (unaudited) and October 31, 2008
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3
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Statements
of Operations for the three month periods ended January 31, 2009 and 2008
and the period March 1, 2002 (inception) to January 31, 2009
(unaudited)
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4
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Statements
of Cash Flow for the three month periods ended January 31, 2009 and 2008
and the period March 1, 2002 (inception) to January 31, 2009
(unaudited)
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5
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|
Notes
to Financial Statements
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7
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|
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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11
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Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk
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16
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Item
4.
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Controls
and Procedures
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16
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PART
II
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OTHER
INFORMATION
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Item
1.
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Legal
Proceedings
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17
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Item
1A.
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Risk
Factors
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17
|
|
||
Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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18
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|
||
Item
6.
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Exhibits
|
18
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SIGNATURES
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19
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January 31, 2009
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October 31, 2008
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|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 199,783 | $ | 59,738 | ||||
Prepaid
expenses
|
27,364 | 38,862 | ||||||
Total
Current Assets
|
227,147 | 98,600 | ||||||
Property
and Equipment, net
|
81,985 | 91,147 | ||||||
Intangible
Assets, net
|
1,210,183 | 1,137,397 | ||||||
Other
Assets
|
3,876 | 3,876 | ||||||
Total
Assets
|
$ | 1,523,191 | $ | 1,331,020 | ||||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 1,008,652 | $ | 998,856 | ||||
Accrued
expenses
|
538,331 | 603,345 | ||||||
Notes
payable - current portion including interest payable
|
528,042 | 563,317 | ||||||
Total
Current Liabilities
|
2,075,025 | 2,165,518 | ||||||
Notes
payable - net of current portion
|
826 | 4,813 | ||||||
Total
Liabilities
|
2,075,851 | $ | 2,170,331 | |||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and
outstanding
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- | - | ||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 111,915,464 as of January 31, 2009; and 109,319,520 as of
October 31, 2008
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111,914 | 109,319 | ||||||
Additional
Paid-In Capital
|
16,686,472 | 16,584,414 | ||||||
Deficit
accumulated during the development stage
|
(17,351,046 | ) | (17,533,044 | ) | ||||
Total
Shareholders' Deficiency
|
$ | (552,660 | ) | $ | (839,311 | ) | ||
Total Liabilities
& Shareholders’ Deficiency
|
$ | 1,523,191 | $ | 1,331,020 |
3 Months
Ended
January 31,
|
3 Months
Ended
January 31,
|
Period from
March 1, 2002
(Inception) to
January 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Revenue
|
$ | - | $ | 22,403 | $ | 1,325,172 | ||||||
Research
& Development Expenses
|
179,174 | 682,163 | 8,037,158 | |||||||||
General
& Administrative Expenses
|
545,454 | 772,590 | 10,554,021 | |||||||||
Total
Operating expenses
|
724,628 | 1,454,752 | 18,591,179 | |||||||||
Loss
from Operations
|
(724,628 | ) | (1,432,350 | ) | (17,266,007 | ) | ||||||
Other
Income:
|
||||||||||||
Interest
expense
|
(15,396 | ) | (1,987 | ) | (1,099,879 | ) | ||||||
Other
Income
|
2 | 32,714 | 246,459 | |||||||||
Gain
on note retirement
|
- | - | 1,532,477 | |||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
- | - | (1,642,232 | ) | ||||||||
Net
(loss) before benefit for income taxes
|
(740,022 | ) | (1,401,623 | ) | (18,229,182 | ) | ||||||
Income
tax benefit
|
922,020 | - | 922,020 | |||||||||
Net
income (loss) after tax
|
181,998 | (1,401,623 | ) | (17,307,162 | ) | |||||||
Dividends
attributable to preferred shares
|
- | - | 43,884 | |||||||||
Net
income loss applicable to Common Stock
|
$ | 181,998 | $ | (1,401,623 | ) | $ | (17,351,046 | ) | ||||
Net
income (loss) per share, basic
|
$ | 0.00 | $ | (0.01 | ) | |||||||
Net
income (loss) per share, diluted
|
$ | 0.00 | $ | (0.01 | ) | |||||||
Weighted
average number of shares outstanding, basic
|
110,222,457 | 107,957,977 | ||||||||||
Weighted
average number of shares outstanding, diluted
|
110,222,457 | 107,957,977 |
3 Months ended
January 31,
|
3 Months ended
January 31,
|
Period from
March 1, 2002
(Inception) to
January 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
income (loss)
|
$ | 181,998 | $ | (1,401,623 | ) | $ | (17,307,162 | ) | ||||
Adjustments
to reconcile net income (loss) to net cash provided by (used in) operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and stock
|
52,676 | 51,889 | 1,905,906 | |||||||||
Amortization
of deferred financing costs
|
- | - | 260,000 | |||||||||
Impairment
of intangible assets
|
26,087 | - | 26,087 | |||||||||
Non-cash
interest expense
|
14,722 | 1,007 | 532,907 | |||||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
- | - | 1,642,232 | |||||||||
Value
of penalty shares issued
|
- | - | 149,276 | |||||||||
Depreciation
expense
|
9,162 | 8,794 | 101,252 | |||||||||
Amortization
expense of intangibles
|
17,349 | 15,858 | 330,860 | |||||||||
Gain
on note retirement
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- | (1,532,477 | ) | |||||||||
Decrease
(Increase) in prepaid expenses
|
11,498 | 52,044 | (27,364 | ) | ||||||||
Increase
in other assets
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- | - | (3,876 | ) | ||||||||
Increase
in accounts payable
|
61,774 | 14,043 | 1,497,836 | |||||||||
(Decrease)
Increase in accrued expenses
|
(65,014 | ) | 121,641 | 522,144 | ||||||||
Increase
in interest payable
|
- | - | 18,291 | |||||||||
Increase
(Decrease) in deferred revenue
|
- | 52,597 | - | |||||||||
Net
cash provided by (used in) operating activities
|
310,252 | (1,083,750 | ) | (11,884,088 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
- | - | (44,940 | ) | ||||||||
Purchase
of property and equipment
|
- | (6,969 | ) | (137,657 | ) | |||||||
Cost
of intangible assets
|
(116,222 | ) | (42,834 | ) | (1,642,082 | ) | ||||||
Net
cash used in Investing Activities
|
(116,222 | ) | (49,803 | ) | (1,824,679 | ) | ||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
960,000 | |||||||||||
Cash
paid for deferred financing costs
|
(260,000 | ) | ||||||||||
Principal
Payments on notes payable
|
(53,985 | ) | (3,546 | ) | (160,904 | ) | ||||||
Proceeds
from notes payable
|
1,746,224 | |||||||||||
Net
proceeds of issuance of Preferred Stock
|
235,000 | |||||||||||
Payment
on cancellation of Warrants
|
(600,000 | ) | ||||||||||
Proceeds
of issuance of Common Stock, net of issuance costs
|
(78,012 | ) | 11,988,230 | |||||||||
Net
cash (used in) provided by Financing Activities
|
(53,985 | ) | (81,558 | ) | 13,908,550 | |||||||
Net
increase (decrease) in cash
|
140,045 | (1,215,111 | ) | 199,783 | ||||||||
Cash
at beginning of period
|
59,738 | 4,041,984 | - | |||||||||
Cash
at end of period
|
$ | 199,783 | $ | 2,826,873 | $ | 199,783 |
3 Months ended
January 31,
|
3 Months ended
January 31,
|
Period from
March 1, 2002
(Inception) to
January 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Equipment
acquired under notes payable
|
- | - | $ | 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 converted to 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
|
- | - | $ | 512,865 | ||||||||
Allocation
of the original secured convertible debentures to warrants
|
- | - | $ | 214,950 | ||||||||
Warrants
Issued in connection with issuance of common stock
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- | - | $ | 1,505,550 |
1.
|
Nature
of Operations and Liquidity
|
2.
|
Basis
of Presentation
|
3.
|
Intangible
Assets:
|
October 31, 2008
|
January 31, 2009
|
Increase/(Decrease)
|
||||||||||
License
|
$ | 529,915 | $ | 570,275 | $ | 40,360 | ||||||
Patents
|
812,910 | 862,685 | 49,775 | |||||||||
Total
intangibles
|
1,342,825 | 1,432,960 | 90,135 | |||||||||
Accumulated
Amortization
|
(205,428 | ) | (222,777 | ) | 17,349 | |||||||
Intangible
Assets
|
$ | 1,137,397 | $ | 1,210,183 | $ | 72,786 |
4.
|
Net
Loss Per Share:
|
As of
January 31, 2008
|
As of
January 31, 2009
|
|||||||
Warrants
|
87,713,770 | 97,187,400 | ||||||
Stock
Options
|
8,512,841 | 8,812,841 | ||||||
Total
All
|
96,226,611 | 106,000,241 |
5.
|
Notes
Payable:
|
6.
|
Derivative
Instruments
|
7.
|
Accounting
for Stock-Based Compensation Plans
|
As
of
January
31, 2008
|
As
of
January
31, 2009
|
|||||||
Research
and development
|
(761 | ) | 16,382 | |||||
General
and Administrative
|
52,650 | 36,293 | ||||||
Total
stock compensation expense recognized
|
$ | 51,889 | $ | 52,675 |
8.
|
Commitments
and Contingencies
|
9.
|
Shareholders
Equity
|
·
|
Clinical
trial expenses decreased by $65,584, or 98%, to $1,038 from $66,622 due to
our close out of our phase I trial in the Fiscal 2008
Quarter.
|
·
|
Wages,
options and lab costs decreased by $160,317, or 56% to $123,541 from
$283,858 principally due to the recording of the full years bonus reversed
in Fiscal 2009 Quarter accrued for over the entire Fiscal 2008 Year. No
bonus accrual was recorded in Fiscal 2009 Quarter.
|
·
|
Consulting
expenses decreased by $7,841, or 20%, to $31,570 from $39,411, primarily
reflecting the lower effort required to prepare the Investigational New
Drug filing for the FDA in the Fiscal 2009 Quarter compared to the same
period last year, partially offset by higher option expense in Fiscal 2009
Quarter.
|
·
|
Subcontracted
research expenses decreased by $41,225, or 100%, to $0 from $41,225
reflecting the completion prior to Fiscal 2009 Quarter of subcontract work
performed by Dr. Paterson at Penn, pursuant to a sponsored research
agreement ongoing in the first quarter Fiscal 2008
Quarter.
|
·
|
Manufacturing
expenses decreased by $201,381, to $23,026 from $224,407, or 90% resulting
the completion of our clinical supply program for the upcoming CIN trial
prior to Fiscal 2009 Quarter compared to the manufacturing program in the
Fiscal 2008.
|
·
|
Toxicology
study expenses decreased by $26,640, to $0 or 100% due the completion in
Fiscal 2008 Quarter of our toxicology study by Pharm Olam in connection
with our ADXS111-001 product candidates in anticipation of clinical
studies in 2008.
|
·
|
Wages,
Options and benefit expenses decreased by $68,552, or 23% to $233,262 from
$301,814 principally due to the recording of the full years bonus reversed
in Fiscal 2009 Quarter accrued for over the entire Fiscal 2008 Year. No
bonus accrual was recorded in Fiscal 2009 Quarter. Option expense in
Fiscal 2009 Quarter was also lower then the prior period due to fewer
options vesting.
|
·
|
Consulting
fees decreased by $98,646, or 79%, to $27,000 from $125,646. This
decrease was primarily attributed to: (i) $46,875 decrease in
Mr. Appel’s (our previous President & CEO) consulting fees recorded in
the Fiscal 2008 Quarter and none recorded in the Fiscal 2009 Quarter.
These decreases in expenses also included lower consulting expenses due to
financial advisor fees of $51,771 recorded in the Fiscal 2008 Quarter
verses the fees for other consultants in the Fiscal 2009
Quarter.
|
·
|
Offering
expenses decreased by $9,697 or 31% to $22,081 from $31,778. A penalty
expense of $31,778 was recorded in the Fiscal 2008 Quarter due to the
delay of effectiveness of the registration statement on Form SB-2, File
No. 333-147752.
|
·
|
A
decrease in legal, accounting, professional and public relations expenses
of $22,320, or 12%, to $168,885 from $191,205, primarily as a result of a
$20,000 expense for the Crystal Investor Research article in Fiscal 2008
Quarter not repeated in Fiscal 2009. Overall the higher accounting and
legal expense in Fiscal 2008 Quarter due to the cost of filing a
registration statement not required in Fiscal 2009 Quarter was essentially
offset by the cost of writing off patent expenses that the company decided
to abandon in Fiscal 2009 Quarter.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $1,859, or
8%, to $26,511 from $24,652 primarily due to an increase in fixed assets
and intangibles in the Fiscal 2009 Quarter compared to the Fiscal 2008
Quarter.
|
·
|
Overall
occupancy and conference related expenses decreased by $29,778 or 31% to
$67,717 from $97,495. Overall conference expense has decreased by $24,940
in the Fiscal 2009 Quarter due to lower participation in cancer
conferences. Additional expenses for travel to Europe for the patent
hearing in Fiscal 2009 Quarter were partially offset by lower data
monitoring costs and Radford Compensation Survey director and officer’s
insurance costs amounting to $8,728 for the Fiscal 2008
Quarter.
|
|
·
|
It
requires assumption 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 material impact in our results of operations or financial
condition.
|
|
·
|
We
have a history of operating losses and we may never achieve profitability.
If we continue to incur losses or we fail to raise additional capital or
receive substantial cash inflows from our partners by May 2009, we may be
forced to cease operations.
|
|
·
|
We
may not be able to make the payments we owe to University of
Pennsylvania for our Licenses or patent
costs.
|
|
·
|
We
may not be able to make the payments we owe to our patent law firm Pearl
Cohen Zedek Latzer LLP
|
|
·
|
We
are highly dependent on the clinical success of our product
candidates.
|
|
·
|
We
are highly dependent upon collaborative partners to develop and
commercialize compounds using our
technology.
|
|
·
|
Our
collaborative partners control the clinical development of certain of our
drug candidates and may terminate their efforts at
will.
|
|
·
|
Our
product candidates are in various stages of development, and we cannot be
certain that any will be suitable for commercial
purposes.
|
|
·
|
Our
business will suffer if we cannot adequately protect our patent and
proprietary rights.
|
|
·
|
We
may be at risk of having to obtain a license from third parties making
proprietary improvements to our
technology.
|
|
·
|
We
are dependent on third parties to manufacture and make clinical
supplies.
|
|
·
|
We
are dependent on our key personnel and if we cannot recruit and retain
leaders in our research, development, manufacturing, and commercial
organizations, our business will be
harmed.
|
|
·
|
Our
future business success depends heavily upon regulatory approvals, which
can be difficult to obtain for a variety of reasons, including
cost.
|
|
·
|
We
may face product liability claims related to participation in clinical
trials for future products.
|
|
·
|
We
are subject to environmental, health and safety laws and regulations for
which we incur costs to comply.
|
|
·
|
We
face rapid technological change and intense
competition.
|
|
·
|
Provisions
of our corporate charter documents, Delaware law, our financing documents
and our stockholder rights plan may dissuade potential acquirers, prevent
the replacement or removal of our current management and members of our
Board of Directors and may thereby affect the price of our common
stock.
|
|
·
|
Our
stock price has been and may continue to be
volatile.
|
|
·
|
Future
sales of common stock or warrants, or the prospect of future sales, may
depress our stock price.
|
|
·
|
For
a more complete listing and description of these and other risks that the
Company faces, please see our Annual Report on Form 10-KSB as filed with
the Securities and Exchange Commission on January 30,
2009.
|
|
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
|
i.
|
Report
on Form 8-K filed December 19, 2008 relating to items: 1.01, 2.03, 8.01
and 9.01.
|
|
|
ii.
|
Report
on Form 8-K filed January 6, 2009 relating to items: 8.01 and
9.01.
|
iii
|
Report
on Form 8-K filed January 16, 2009 relating to items:
8.01.
|
|
iv
|
Report
on Form 8-K filed February 13, 2009 relating to items:
7.01
|
ADVAXIS,
INC.
Registrant
|
||
Date: March
13, 2009
|
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
|