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 small business issuer 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
|
(Issuer’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
|
3
|
Balance
Sheets at July 31, 2009 (unaudited) and October 31, 2008
|
3
|
|
Statements
of Operations for the three and nine month periods ended July 31, 2009 and
2008 and the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
4
|
|
Statements
of Cash Flow for the nine month periods ended July 31, 2009 and 2008 and
the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
5
|
|
Notes
to Financial Statements
|
7
|
|
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
23
|
Item 4.
|
Controls
and Procedures
|
23
|
PART II
|
OTHER
INFORMATION
|
|
Item 1.
|
Legal
Proceedings
|
23
|
Item 1A.
|
Risk
Factors
|
23
|
Item 6.
|
Exhibits
|
25
|
SIGNATURES
|
26
|
July
31, 2009
|
October 31, 2008
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$
|
49,126
|
$
|
59,738
|
||||
Prepaid
expenses
|
40,105
|
38,862
|
||||||
Total
Current Assets
|
89,231
|
98,600
|
||||||
Deferred
expenses
|
366,938
|
-
|
||||||
Property
and Equipment, net
|
63,661
|
91,147
|
||||||
Intangible
Assets, net
|
1,310,078
|
1,137,397
|
||||||
Other
Assets
|
3,876
|
3,876
|
||||||
Total
Assets
|
$
|
1,833,784
|
$
|
1,331,020
|
||||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
1,362,832
|
$
|
998,856
|
||||
Accrued
expenses
|
965,886
|
603,345
|
||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
796,154
|
-
|
||||||
Notes
payable - current portion including interest payable
|
1,094,450
|
563,317
|
||||||
Total
Current Liabilities
|
4,219,322
|
2,165,518
|
||||||
Common
Stock Warrants
|
11,253,594
|
-
|
||||||
Notes
payable - net of current portion
|
-
|
4,813
|
||||||
Total
Liabilities
|
$
|
15,472,916
|
$
|
2,170,331
|
||||
Commitments and
Contingencies
|
||||||||
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 115,638,243 as of July 31, 2009; and 109,319,520 as of October
31, 2008
|
115,637
|
109,319
|
||||||
Additional
Paid-In Capital
|
4,217,074
|
16,584,414
|
||||||
Deficit
accumulated during the development stage
|
(17,971,843
|
)
|
(17,533,044
|
)
|
||||
Total
Shareholders' Deficiency
|
$
|
(13,639,132
|
)
|
$
|
(839,311
|
)
|
||
Total Liabilities
& Shareholders’ Deficiency
|
$
|
1,833,784
|
$
|
1,331,020
|
3 Months
Ended
July
31,
2009
|
3 Months
Ended
July
31,
2008
|
9 Months
Ended
July
31,
2009
|
9 Months
Ended
July
31,
2008
|
Period from
March 1, 2002
(Inception) to
July
31,
2009
|
||||||||||||||||
Revenue
|
$ | (5,369 | ) | $ | 28,045 | $ | (5,369 | ) | $ | 68,404 | $ | 1,319,803 | ||||||||
Research
& Development Expenses
|
476,421 | 657,286 | 939,407 | 2,004,324 | 8,797,391 | |||||||||||||||
General
& Administrative Expenses
|
985,726 | 605,319 | 2,019,648 | 2,349,439 | 12,028,215 | |||||||||||||||
Total
Operating expenses
|
1,462,147 | 1,262,605 | 2,959,055 | 4,353,763 | 20,825,606 | |||||||||||||||
Loss
from Operations
|
(1,467,516 | ) | (1,234,560 | ) | (2,964,424 | ) | (4,285,359 | ) | (19,505,803 | ) | ||||||||||
Other
Income (expense):
|
||||||||||||||||||||
Interest
expense
|
(374,563 | ) | (1,773 | ) | (410,615 | ) | (5,705 | ) | (1,495,098 | ) | ||||||||||
Other
Income
|
- | 2,599 | 46,427 | 246,457 | ||||||||||||||||
Gain
on note retirement
|
- | - | - | - | 1,532,477 | |||||||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
2,014,220 | - | 2,014,220 | - | 371,988 | |||||||||||||||
Net
income (loss) before benefit for income tax benefit
|
172,141 | (1,233,734 | ) | (1,360,819 | ) | (4,244,637 | ) | (18,849,979 | ) | |||||||||||
Income
tax benefit
|
- | - | 922,020 | - | 922,020 | |||||||||||||||
Net
income (loss)
|
172,141 | (1,233,734 | ) | (438,799 | ) | - | (17,927,959 | ) | ||||||||||||
Dividends
attributable to preferred shares
|
- | - | - | - | 43,884 | |||||||||||||||
Net
income (loss) applicable to common Stock
|
$ | 172,141 | $ | (1,233,734 | ) | $ | (438,799 | ) | $ | (4,244,637 | ) | $ | (17,971,843 | ) | ||||||
Net
income (loss) per share, basic
|
$ | 0.00 | $ | (0.01 | ) | $ | 0.00 | $ | (0.04 | ) | ||||||||||
Net
income (loss) per share, diluted
|
$ | 0.00 | $ | (0.01 | ) | $ | 0.00 | $ | (0.04 | ) | ||||||||||
Weighted
average number of shares outstanding, basic
|
115,243,678 | 109,157,170 | 112,599,706 | 108,513,191 | ||||||||||||||||
Weighted
average number of shares outstanding, diluted
|
115,243,678 | 109,157,170 | 112,599,706 | 108,513,191 |
9
Months
ended
July
31,
|
9
Months
ended
July
31,
|
Period
from
March 1, 2002
(Inception) to
July
31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (438,799 | ) | $ | (4,244,637 | ) | $ | (17,927,959 | ) | |||
Adjustments
to reconcile net loss
|
||||||||||||
to
net cash used in operating activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and
stock
|
372,695 | 311,806 | 2,225,925 | |||||||||
Amortization
of deferred financing costs
|
- | - | 260,000 | |||||||||
Amortization
of Discount on bridge Loan
|
37,231 | - | 37,321 | |||||||||
Amortization
of Warrants on Bridge Notes
|
- | 53,851 | ||||||||||
Non-cash
interest expense
|
345,044 | 3,002 | 863,229 | |||||||||
Change
in value of warrants and embedded derivative
|
(2,014,220 | ) | - | (371,988 | ) | |||||||
Value
of penalty shares issued
|
- | 31,778 | 149,276 | |||||||||
Depreciation
expense
|
27,486 | 26,975 | 119,576 | |||||||||
Amortization
expense of intangibles
|
54,374 | 51,795 | 367,885 | |||||||||
Gain
on note retirement
|
- | - | (1,532,477 | ) | ||||||||
(Increase)
Decrease in prepaid expenses
|
(1,243 | ) | 94,711 | (40,105 | ) | |||||||
Increase
in other assets
|
- | - | (3,876 | ) | ||||||||
Increase
in Deferred expenses
|
(116,938 | ) | - | (116,938 | ) | |||||||
Increase
in accounts payable
|
415,954 | 113,162 | 1,852,016 | |||||||||
Increase
in accrued expenses
|
112,541 | 101,781 | 699,699 | |||||||||
Accrued
interest on notes payable
|
- | - | 18,291 | |||||||||
Increase
in deferred revenue
|
- | 6,596 | - | |||||||||
Net
cash used in Operating Activities
|
(1,205,873 | ) | (3,503,031 | ) | (13,400,213 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
- | - | (44,940 | ) | ||||||||
Purchase
of property and equipment
|
- | (10,842 | ) | (137,657 | ) | |||||||
Cost
of intangible assets
|
(227,054 | ) | (178,542 | ) | (1,752,914 | ) | ||||||
Net
cash used in Investing Activities
|
(227,054 | ) | (189,384 | ) | (1,935,511 | ) | ||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
- | - | 960,000 | |||||||||
Cash
paid for deferred financing costs
|
(260,000 | ) | ||||||||||
Principal
payment on notes payable
|
(12,320 | ) | (10,960 | ) | (119,239 | ) | ||||||
Proceeds
from notes payable
|
- | - | 1,271,224 | |||||||||
Proceeds
from notes payable
|
1,434,635 | - | 1,909,635 | |||||||||
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
|
- | (78,013 | ) | 11,988,230 | ||||||||
Net
cash provided by (used in) Financing Activities
|
$ | 1,422,315 | $ | (88,973 | ) | $ | 15,384,850 | |||||
Net
(Decrease) Increase in cash
|
(10,612 | ) | (3,781,388 | ) | 49,126 | |||||||
Cash
at beginning of period
|
59,738 | 4,041,984 | - | |||||||||
Cash
at end of period
|
$ | 49,126 | $ | 260,596 | $ | 49,126 |
9 Months
ended
July
31,
|
9 Months
ended
July
31,
|
Period from
March 1, 2002
(Inception) to
|
||||||||
2009
|
2008
|
July 31, 2009
|
||||||||
|
|
|||||||||
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
|
||||||
D
Debt discount in connection with recording the original value of the
embedded derivative liability
|
$
|
1,023,116
|
-
|
$
|
1,535,912
|
|||||
Allocation
of the original secured convertible debentures to warrants
|
-
|
-
|
$
|
214,950
|
||||||
Allocation
of the Warrant on Bridge Loan as debt discount
|
$
|
250,392
|
$
|
250,392
|
||||||
Warrants
issued in connection with issuances of common stock
|
-
|
-
|
$
|
1,505,550
|
||||||
Warrants
recorded as a liability
|
$
|
12,785,695
|
$
|
12,785,695
|
1.
|
Nature of
Operations and Liquidity
|
2.
|
Basis of
Presentation
|
3.
|
Intangible
Assets
|
October 31,
2008
|
July 31,
2009
|
Increase/(Decrease)
|
||||||||||
License
|
$
|
529,915
|
$
|
571,275
|
$
|
41,360
|
||||||
Patents
|
812,910
|
998,605
|
185,695
|
|||||||||
Total
intangibles
|
1,342,825
|
1,569,880
|
227,055
|
|||||||||
Accumulated
Amortization
|
(205,428
|
)
|
(259,802
|
)
|
(54,374
|
)
|
||||||
Intangible
Assets
|
$
|
1,137,397
|
$
|
1,310,078
|
$
|
172,681
|
4.
|
Net Income
(Loss) Per Share
|
As of
July 31, 2008
|
As of
July 31, 2009
|
|||||||
Warrants
|
94,149,587
|
89,143,801
|
||||||
Stock
Options
|
8,812,841
|
17,962,841
|
||||||
Total
All
|
102,962,428
|
107,106,642
|
5.
|
Notes
Payable
|
6.
|
Derivative
Instruments
|
|
(i)
|
$0.20
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 312.32%, Life 145 to 1825 days, warrants outstanding
89,143,801.
|
|
(ii)
|
$0.135
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 312.32%, Life 145 to 1825 days warrants outstanding
123,269,393
|
|
(iii)
|
$0.055
exercise price, market price $0.11, risk free interest 1.00% to 2.86%,
volatility 170.16% to 312.32%, Life 620 to 1825 days, warrants outstanding
202,416,414
|
|
(i)
|
$0.20 exercise price, market price $0.09, risk free interest 0.18% to 2.53%, volatility 170.16% to 294.68%, Life 102 to 1782 days warrants outstanding 89,143,801. |
|
(ii)
|
$0.135 exercise price, market price $0.09, risk free interest 0.18% to 2.53%, volatility 170.16% to 294.68%, Life 102 to 1782 days, warrants outstanding 123,269,393 |
|
(iii)
|
$0.055 exercise price, market price $0.09, risk free interest 0.8% to 2.53%, volatility 170.16% to 294.68%, Life 579 to 1782 days warrants outstanding 244,073,417 |
|
·
|
$0.20/share
at a 50% conversion divided into $1,131,353 equals 11,313,530 shares plus
warrant & share dilution (1).
|
|
·
|
$0.10/share
at a 50% conversion divided into $1,131,353 equals 22,627,060 shares plus
warrant & share dilution (1).
|
|
·
|
$0.05/share
at a 50% conversion divided into $1,131,353 or 45,254,120 shares plus
warrant and share dilution (1).
|
|
·
|
$0.01/share
at a 50% conversion divided into $1,131,353 or 226,270,600 shares plus
warrant and share dilution (1).
|
7.
|
Accounting for
Stock-Based Compensation
Plans
|
For the nine
month period
ended
July 31, 2008
|
For the nine
month period
ended
July 31, 2009
|
|||||||
Research
and development
|
474
|
143,486
|
||||||
General
and Administrative
|
157,009
|
202,984
|
||||||
Total
stock compensation expense recognized
|
$
|
157,483
|
$
|
346.470
|
8.
|
Commitments
and Contingencies
|
9.
|
Shareholders
Equity
|
Additional
Paid-In Capital:
|
||||
Balance
as of October 31, 2008:
|
$ | 16,584,414 | ||
Warrants
converted into common stock
|
( 3,300 | ) | ||
Common
stock issued to consultants
|
67,140 | |||
Stock
options granted to employees and consultants
|
354,515 | |||
Warrant
Liability recorded at inception
|
(12,785,695 | ) | ||
Balance
as of July 31, 2009
|
$ | 4,217,074 |
10.
|
Subsequent
Events
|
|
●
|
Clinical trial expenses decreased
by $88,536, or 49%, to $92,245 from $180,781 due to the close out billing
of our phase I trial in the first Fiscal 2008 Quarter which more than
off set the one-half month of start-up cost of our phase II cervical
cancer study in India in the Fiscal 2009
Quarter.
|
|
●
|
Wages, options and lab costs
increased by $35,236, or 11% to $353,647 from $318,411 principally due to
higher option expense of $105,069 relating to new grants partially offset
by lower compensation cost of $54,386 primarily due to no bonus accrual
recorded in Fiscal 2009 Quarter compared to a $43,858 accrual recorded in
Fiscal 2008 Quarter as well as lower overall lab costs due to the priority
given to grant and publication
writing.
|
|
●
|
Consulting expenses increased by
$34,162, or 365%, to $43,519 from $9,357, principally due to higher option
expense of $25,375 recorded in Fiscal 2009 Quarter relating to new grants
partially offset by lower stock prices in the Fiscal 2008 Quarter that
resulted in a credit to option expense of $28,550 due to the true up of
unvested option expense recorded in Fiscal 2008. This $53,925 increase,
overall, of option expense was offset in part by lower effort required to
prepare the Investigational New Drug filing for the FDA or $11,763 and
lower other consulting expense of $8,000 in Fiscal 2009 Quarter compared
to the same period last
year.
|
|
●
|
Subcontracted research expenses
decreased by $39,900, or 100%, to $0 from $39,900 reflecting its
completion prior to Fiscal 2009 Quarter of subcontract work performed by
Dr. Paterson at Penn, pursuant to a sponsored research agreement ongoing
in the same period last Fiscal 2008
Quarter.
|
|
●
|
Manufacturing expenses decreased
by $99,036, to $9,802 from $108,838, or 91% resulting from the completion
of our clinical supply program for the upcoming cervical cancer and CIN
trial prior to Fiscal 2009 Quarter compared to the manufacturing program
in the Fiscal 2008
Quarter.
|
|
●
|
Wages, Options and benefit
expenses increased by $85,429, or 30% to $370,374 from $284,945
principally due to higher option expense of $105,112 primarily due to new
stock option grants partially offset by lower compensation and benefit
cost of $19,683 in Fiscal 2009 Quarter compared to those expenses recorded
in Fiscal 2008 Quarter.
|
|
●
|
Consulting fees increased by
$11,685, or 29%, to $51,367 from $39,682. This increase was primarily
attributed to new stock options grants to consultants of $21,367 recorded
partially offset by lower consulting fees of $9,682 in Fiscal 2009 Quarter
compared to the Fiscal 2008
Quarter.
|
|
●
|
Offering expenses increased by
$268,212 to $269,562 from $1,350. The offering expenses of $308,596
consist of legal cost in preparation for financial raises and SEC filings,
partially offset by a reversal of a non-cash warrant expenses in Fiscal
2009 Quarter.
|
|
●
|
An increase in legal, accounting,
professional and public relations expenses of $78,968, or 52%, to $230,795
from $151,827, is primarily the result of higher legal ($105,447) and
filing fees ($4,215) off set in part by lower tax prep ($7,622), patent
expenses ($9,293) and public relations fees ($17,388) in Fiscal 2009
Quarter than in Fiscal 2008
Quarter
|
|
●
|
Amortization of intangibles and
depreciation of fixed assets increased by $1,512, or 6%, to $28,102 from
$26,590 primarily due to no increase in fixed assets and an increase in
intangibles in the Fiscal 2009 Quarter compared to the Fiscal 2008
Quarter.
|
|
●
|
Overall occupancy and conference
related expenses decreased by $44,032 or 44% to $56,894 from $100,926.
Overall conference expense decreased by $18,093 in the Fiscal 2009 Quarter
due to lower participation in cancer conferences as well as lower travel
expenses to the conferences of $13,504 than compared to Fiscal 2008
Quarter. The remaining decrease of $12,435 was primarily due lower patent
expense.
|
|
●
|
Clinical trial expenses decreased
by $187,512, or 67%, to $94,013 from $281,525 primarily due to the close
out of our phase I trial in the Fiscal 2008 Period which more than
off set the one-half month of start-up cost of our phase II cervical
cancer study in India in the Fiscal 2009
Period.
|
|
●
|
Wages, options and lab costs
decreased by $171,571or 19% to $718,850 from $888,212 principally due to
the recording of the full years bonus accrual in Fiscal 2008 that was
reversed in Fiscal 2009 Period or $242,385. No bonus accrual was recorded
nor paid in Fiscal 2009 Period. Overall the lab costs were lower due to
the priority given to the lower cost of grant and publication writing.
These lower costs were partially offset by $107,624 higher option expense
relating to new grants in Fiscal 2009 Period and $40,930 in wages
primarily due to the new hire of the Executive Director, Product
Development in March
2008.
|
|
●
|
Consulting expenses increased by
$11,829, or 12%, to $107,709 from $95,880, principally due to higher
option expense of $30,835 recorded in Fiscal 2009 Period relating to new
grants as compared to a credit to option expense of $36,922 due to the
true up of unvested option expense recorded in prior Fiscal periods. This
resulted in a $67,757 increase, overall, of option expense which was
offset in part by the lower effort required to prepare the Investigational
New Drug filing for the FDA or $56,928 in the Fiscal 2009 Period compared
to the same period last
year.
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●
|
Subcontracted research expenses
decreased by $121,023, or 100%, to $0 from $121,023 reflecting the
completion of the project prior to Fiscal 2009 Period performed by Dr.
Paterson at Penn, pursuant to a sponsored research agreement ongoing in
the Fiscal 2008 Period.
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●
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Manufacturing expenses decreased
by $547,208, to $41,626 from $588,834, or 93% resulting from the
completion of our clinical supply program for the upcoming CIN trial prior
to Fiscal 2009 Period compared to the manufacturing program in the Fiscal
2008.
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●
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Toxicology study expenses
decreased by $26,640, to $0 or 100% due the completion in Fiscal 2008
Period of our toxicology study by Pharm Olam in connection with our
ADXS111-001 product candidates in anticipation of clinical studies in
2008.
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●
|
Wages, Options and benefit
expenses decreased by $113,876, or 12% to $828,290 from $942,166
principally due to the reversal of a nine month bonus accrual in Fiscal
2009 Period or $79,039 that was recorded as expense in Fiscal 2008 Period
(no bonus accrual was recorded nor paid in Fiscal 2009 Period) and no
stock was issued in Fiscal 2009 Period compared to $71,250 worth of stock
was issued to the CEO per his employment agreement in Fiscal 2008
Period. These lower expenses were partially offset by higher
option expense of $45,975 primarily due to new stock options granted in
Fiscal 2009 Period resulting in a $105,112 expense partially offset by
lower option expenses recorded in Fiscal 2009 Period due to the nine
months vesting of the CEO’s options in Fiscal 2008 Period compared to two
months of vesting of his options in the Fiscal 2009
Period.
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●
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Consulting fees decreased by
$272,769, or 73%, to $99,150 from $371,919. This decrease was
primarily attributed to a one-time payment in settlement of Mr. Appel’s
(our previous President & CEO) employment agreement of $130,000
recorded in the Fiscal 2008 Period. The consulting expenses were also
$180,571 lower due to reduced financial advisor fees in Fiscal 2009 Period
compared to $200,571 recorded in the Fiscal 2008 Period primarily due to
the close of the offering on October 17, 2007. These lower fees were
partially offset by $50,000 fees recorded for the Sage Group in Fiscal
2009 Period for seeking corporate partnerships that didn’t occur in Fiscal
2008 Period.
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●
|
Offering expenses increased by
$302,505 to $335,633 from $33,128. The offering expenses of $351,973
recorded included in Fiscal 2009 Period or an increase of $318,845
consists of legal costs in preparation for financial raises and SEC
filings that didn’t occur in Fiscal 2008 Period, partially offset by
non-cash warrants expense.
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●
|
An increase in legal, accounting,
professional and public relations expenses of $77,121, or 18%, to $516,521
from $439,400, primarily as a result of a higher overall legal, patent
expenses of $114,049 partially offset by lower accounting, Public
relations and tax preparation fees in Fiscal 2009 Period than in the
Fiscal 2008 Period.
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●
|
Amortization of intangibles and
depreciation of fixed assets increased by $3,090, or 4%, to $81,860 from
$78,770 primarily due to an increase in fixed assets and intangibles in
the Fiscal 2009 Period compared to the Fiscal 2008
Period.
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|
●
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Analysis Research cost decreased
by $117,990 or 100%, to $0 from $117,990 due to a one time report and
business analysis report in the Fiscal 2008 Period not repeated in Fiscal
2009 Period.
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●
|
Recruiting fees for the Executive
Director of Product Development in Fiscal 2008 Period was $63,395 and
there was no such expense in Fiscal 2009
Period.
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●
|
Overall occupancy and conference
related expenses decreased by $123,110 or 41% to $179,561 from $302,672.
Conference and dues and subscription expenses have decreased by $89,044 in
the Fiscal 2009 Period due to lower participation in cancer conferences.
In addition lower travel related to the reduced conferences attendance
amounted to a decrease of $21,061 in the Fiscal 2009 Period than incurred
in Fiscal 2008
Period.
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●
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It requires assumption to be made
that were uncertain at the time the estimate was made,
and
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|
●
|
Changes in the estimate of
difference estimates that could have been selected could have material
impact in our results of operations or financial
condition.
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●
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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 investors by September 2009, we may be forced to
cease operations.
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●
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We may be forced into
bankruptcy.
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●
|
Our next raise may be at a stock
price that will trigger a significant dilution due to price and trigger
ratchets in the shares and
warrants.
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●
|
We may not be able to make back
payments we owe to Penn for our Licenses or patent
costs.
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●
|
We may not be able to make the
payments we owe to our patent law firm Pearl Cohen Zedek Latzer
LLP
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●
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We are highly dependent on the
clinical success of our product
candidates.
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●
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We are highly dependent upon
collaborative partners to develop and commercialize compounds using our
technology.
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●
|
Our collaborative partners
control the clinical development of certain of our drug candidates and may
terminate their efforts at
will.
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●
|
Our product candidates are in
various stages of development, and we cannot be certain that any will be
suitable for commercial
purposes.
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●
|
Our business will suffer if we
cannot adequately protect our patent and proprietary
rights.
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●
|
We may be at risk of having to
obtain a license from third parties making proprietary improvements to our
technology.
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●
|
We are dependent on third parties
to manufacture and make clinical
supplies.
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●
|
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.
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●
|
Our future business success
depends heavily upon regulatory approvals, which can be difficult to
obtain for a variety of reasons, including
cost.
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●
|
We may face product liability
claims related to participation in clinical trials for future
products.
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●
|
We are subject to environmental,
health and safety laws and regulations for which we incur costs to
comply.
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●
|
We face rapid technological
change and intense
competition.
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●
|
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.
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●
|
Our stock price has been and may
continue to be volatile.
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●
|
Future sales of common stock or
warrants, or the prospect of future sales, may depress our stock price by
trigger substantial dilution of our stock due the share price and or
ratchets in the warrants and the stock purchase
agreements.
|
3.1(i)
|
Amended
and Restated Articles of Incorporation. (Incorporated by reference to
Annex C to DEF 14A Proxy Statement filed with the SEC on May 15,
2006)
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|
3.1(ii)
|
Amended
and Restated Bylaws. (Incorporated by reference to Exhibit 10.4
to Quarterly Report on Form 10-QSB filed with the SEC on December 15,
2006)
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|
4.1
|
Form
of Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.1
to current report on Form 8-K filed with the SEC on June 19,
2009)
|
|
4.2
|
Form
of Senior Secured Convertible Note (Incorporated by reference to Exhibit
4.2 to current report on Form 8-K filed with the SEC on June 19,
2009)
|
|
4.3
|
Form
of Senior Promissory Note as Amended, between Advaxis, Inc. and Thomas
Moore (Incorporated by reference to Exhibit 4.3 to current report on Form
8-K filed with the SEC on June 19, 2009)
|
|
10.1
|
Form
of Note Purchase Agreement (Incorporated by reference to Exhibit 10.1 to
current report on Form 8-K filed with the SEC on June 19,
2009)
|
|
10.2
|
Form
of Security Agreement (Incorporated by reference to Exhibit 10.2 to
current report on Form 8-K filed with the SEC on June 19,
2009)
|
|
10.3
|
Form
of Subordination Agreement (Incorporated by reference to Exhibit 10.3 to
current report on Form 8-K filed with the SEC on June 19,
2009)
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|
31.1
|
Certification
of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002
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31.2
|
Certification
of Principal Financial Officer pursuant to section 302 of the
Sarbanes-Oxley Act of 2002
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|
32.1
|
Certification
of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley
Act of 2002
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32.2
|
Certification
of Principal Financial Officer pursuant to section 906 of the
Sarbanes-Oxley Act of
2002
|
ADVAXIS,
INC.
Registrant
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||
Date:
September 23, 2009
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By:
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/s/ Thomas Moore
|
Thomas
Moore
Chief
Executive Officer and Chairman of the Board
|
||
By:
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/s/ Fredrick Cobb
|
|
Fredrick
Cobb
Vice
President Finance, Principal Financial
Officer
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