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 January 31, 2010 (unaudited) and October 31, 2009
|
2
|
|
Statements
of Operations for the three month periods ended January 31, 2010 and 2009
and the period March 1, 2002 (inception) to January 31, 2010
(unaudited)
|
3
|
|
Statements
of Cash Flow for the three month periods ended January 31, 2010 and 2009
and the period March 1, 2002 (inception) to January 31, 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
|
12
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
18
|
Item
4T.
|
Controls
and Procedures
|
18
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
18
|
Item
1A.
|
Risk
Factors
|
18
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
18
|
Item
6.
|
Exhibits
|
19
|
SIGNATURES
|
20
|
January
31, 2010
|
October 31,
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$
|
1,113,956
|
$
|
659,822
|
||||
Prepaid
expenses
|
42,910
|
36,445
|
||||||
Total
Current Assets
|
1,156,866
|
696,267
|
||||||
Deferred
expenses
|
247,536
|
288,544
|
||||||
Property
and Equipment (net of accumulated depreciation)
|
55,101
|
54,499
|
||||||
Intangible
Assets (net of accumulated amortization)
|
1,449,870
|
1,371,638
|
||||||
Deferred
Financing Cost
|
-
|
299,493
|
||||||
Other
Assets
|
6,138
|
3,876
|
||||||
TOTAL
ASSETS
|
$
|
2,919,511
|
$
|
2,714,317
|
||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
2,659,522
|
$
|
2,368,716
|
||||
Accrued
expenses
|
673,017
|
917,250
|
||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
2,645,990
|
2,078,851
|
||||||
Notes
payable – including interest payable
|
1,155,757
|
1,121,094
|
||||||
Total
Current Liabilities
|
7,134,286
|
6,485,911
|
||||||
Common
Stock Warrant
|
12,665,150
|
11,961,734
|
||||||
Total
Liabilities
|
$
|
19,799,436
|
$
|
18,447,645
|
||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; 145 shares issued
and outstanding
|
-
|
|||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 127,201,243 at January 31, 2010 and 115,638,243 at October 31,
2009
|
127,200
|
115,638
|
||||||
Additional
Paid-In Capital
|
5,619,739
|
754,834
|
||||||
Stock
subscription receivable
|
(1,965,710
|
)
|
-
|
|||||
Deficit
accumulated during the development stage
|
(20,665,154
|
)
|
(16,603,800
|
)
|
||||
Total
Shareholders' Deficiency
|
(16,883,925
|
)
|
(15,733,328
|
)
|
||||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$
|
2,915,511
|
$
|
2,714,317
|
Three
Months
Ended
January
31,
|
Three
Months
Ended
January
31,
|
Period
from
March 1, 2002
(Inception) to
January
31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
Revenue
|
$
|
-
|
$
|
$
|
1,354,862
|
|||||||
Research
& Development Expenses
|
997,335
|
179,174
|
11,170,876
|
|||||||||
General
& Administrative Expenses
|
589,015
|
545,454
|
13,298,715
|
|||||||||
Total
Operating expenses
|
1,586,350
|
724,628
|
24,469,591
|
|||||||||
Loss
from Operations
|
(1,586,350
|
)
|
(724,628
|
)
|
(23,114,729
|
)
|
||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(1,666,139
|
)
|
(15,396
|
)
|
(3,601,630
|
)
|
||||||
Other
Income
|
2,271
|
2
|
248,728
|
|||||||||
Gain
on note retirement
|
-
|
-
|
1,532,477
|
|||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
(1,090,114
|
)
|
-
|
3,112,883
|
||||||||
Net
(Loss) before income tax benefit
|
(4,340,332
|
)
|
(740,022
|
)
|
(21,822,271
|
)
|
||||||
Income
tax benefit
|
278,978
|
922,020
|
1,201,001
|
|||||||||
Net
(Loss) Income
|
(4,061,354
|
)
|
181,998
|
(20,621,270
|
)
|
|||||||
Dividends
attributable to preferred shares
|
-
|
-
|
(43,884
|
)
|
||||||||
Net
Income (Loss) applicable to Common Stock
|
$
|
(4,061,354
|
)
|
$
|
181,998
|
$
|
(20,665,154
|
)
|
||||
Net
income (Loss) per share, basic
|
$
|
(.03
|
)
|
$
|
0.00
|
|||||||
Net
income (Loss) per share, diluted
|
$
|
(.03
|
)
|
$
|
0.00
|
|||||||
Weighted
average number of shares outstanding, basic
|
118,277,623
|
110,222,457
|
||||||||||
Weighted
average number of shares outstanding, diluted
|
118,277,623
|
110,222,457
|
Three
Months
Ended
January 31,
|
Three
Months
Ended
January 31,
|
Period from
March 1, 2002
(Inception) to
January 31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
income/(Loss)
|
$
|
(4,061,354
|
)
|
$
|
181,998
|
$
|
(20,621,270
|
)
|
||||
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
|
188,177
|
52,676
|
2,612,932
|
|||||||||
Amortization
of deferred financing costs
|
-
|
260,000
|
||||||||||
Amortization
of deferred expenses
|
41,008
|
102,464
|
||||||||||
Amortization
of discount on Bridge Loans
|
225,320
|
349,166
|
||||||||||
Impairment
of intangible assets
|
26,087
|
26,087
|
||||||||||
Non-cash
interest expense
|
1,433,436
|
14,722
|
2,650,272
|
|||||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
1,090,114
|
-
|
(3,112,883
|
)
|
||||||||
Value
of penalty shares issued
|
-
|
149,276
|
||||||||||
Depreciation
expense
|
9,412
|
9,162
|
138,150
|
|||||||||
Amortization
expense of intangibles
|
21,267
|
17,349
|
383,199
|
|||||||||
Gain
on note retirement
|
(1,532,477
|
)
|
||||||||||
Decrease
(Increase) in prepaid expenses
|
(6,464
|
)
|
11,498
|
(42,909
|
)
|
|||||||
Increase
in other assets
|
-
|
-
|
(3,876
|
)
|
||||||||
Increase
in accounts payable
|
441,848
|
61,774
|
3,299,748
|
|||||||||
(Decrease)
Increase in accrued expenses
|
(244,234
|
)
|
(65,014
|
)
|
233,384
|
|||||||
-
|
||||||||||||
(Decrease)
Increase in interest payable
|
-
|
-
|
18,291
|
|||||||||
Net
cash provided by (used in) operating activities
|
(861,470
|
)
|
310,252
|
(15,090,447
|
)
|
|||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||||
Purchase
of property and equipment
|
(10,014
|
)
|
-
|
(147,671
|
)
|
|||||||
Cost
of intangible assets
|
(99,500
|
)
|
(116,222
|
)
|
(1,934,109
|
)
|
||||||
Net
cash provided by (used in) Investing Activities
|
(109,514
|
)
|
(116,222
|
)
|
(2,126,720
|
)
|
||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from (repayment of) convertible secured debenture
|
-
|
-
|
960,000
|
|||||||||
Cash
paid for deferred financing costs
|
-
|
-
|
(559,493
|
)
|
||||||||
Principal
Payments on notes payable
|
(213,382
|
)
|
(53,985
|
)
|
(336,973
|
)
|
||||||
Proceeds
from notes payable
|
472,500
|
5,478,359
|
||||||||||
Payment
on notes payable
|
-
|
-
|
||||||||||
Net
proceeds of issuance of Preferred Stock
|
1,166,000
|
1,401,000
|
||||||||||
Cancellation
of Warrants
|
-
|
(600,000
|
)
|
|||||||||
Net
proceeds of issuance of Common Stock
|
-
|
11,988,230
|
||||||||||
Net
cash provided by Financing Activities
|
1,425,118
|
(53,985
|
)
|
18,331,124
|
||||||||
Net
increase (decrease) in cash
|
454,134
|
140,045
|
1,113,956
|
|||||||||
Cash
at beginning of period
|
659,822
|
59,738
|
||||||||||
Cash
at end of period
|
$
|
1,113,956
|
$
|
199,783
|
$
|
1,113,956
|
Three
Months
Ended
January 31,
|
Three
Months
Ended
January 31,
|
Period from
March 1, 2002
(Inception) to
January 31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
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 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
|
$
|
267,800
|
-
|
$
|
2,350,242
|
|||||||
Allocation
of the original secured convertible debentures to warrants
|
-
|
-
|
$
|
214,950
|
||||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$
|
410,116
|
-
|
$
|
1,350,627
|
|||||||
Note
receivable in connection with exercise of warrants
|
$
|
1,965,710
|
-
|
$
|
1,965,710
|
|||||||
Warrants
Issued in connection with issuance of Common Stock
|
-
|
-
|
$
|
1,505,550
|
||||||||
Warrants
Issued in connection with issuance of Preferred Stock
|
-
|
-
|
$
|
3,587,625
|
1.
|
Nature of Operations and
Liquidity
|
2.
|
Basis of
Presentation
|
3.
|
Intangible
Assets:
|
January
31,
2010
|
October
31,
2009
|
|||||||
License
|
$ | 641,274 | $ | 571,275 | ||||
Patents
|
1,109,798 | 1,080,299 | ||||||
Total
intangibles
|
1,751,073 | 1,651,574 | ||||||
Accumulated
Amortization
|
(301,203 | ) | (279,936 | ) | ||||
Intangible
Assets
|
$ | 1,449,870 | $ | 1,371,638 |
4.
|
Net Loss Per
Share:
|
As
of
January
31, 2010
|
As
of
January
31, 2009
|
|||||||
Warrants
|
98,267,159
|
97,187,400
|
||||||
Stock
Options
|
19,129,507
|
8,812,841
|
||||||
Total
|
117,396,666
|
106,000,241
|
5.
|
Notes Payable
and Derivative Instruments:
|
Bridge
Note – Principal Value - Issued
|
3,834,294
|
|||
Principal
payments on Bridge Notes
|
(203,382
|
)
|
||
Original
Issue Discount, net of accreted interest
|
(225,
977
|
)
|
||
Fair
Value of Attached Warrants at issuance
|
(1,350,629)
|
|||
Fair
Value of Embedded Derivatives at issuance
|
(2,159,304
|
)
|
||
Accreted
interest on embedded derivative and warrant liabilities
|
2,301,933
|
|||
Convertible
Bridge Notes- as of January 31, 2010
|
$
|
2,196,935
|
||
Embedded
Derivatives Liability at January 31, 2010
|
449,055
|
|||
Convertible Bridge
Notes and fair value of embedded derivative
|
$
|
2,645,990
|
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
|
Accounting for
Stock-Based Compensation
Plans
|
As
of
January
31,
2010
|
As
of
January
31,
2009
|
|||||||
Research
and development
|
$
|
22,790
|
$
|
16,382
|
||||
General
and Administrative
|
165,387
|
36,293
|
||||||
Total
stock compensation expense recognized
|
$
|
188,177
|
$
|
52,675
|
7.
|
Commitments
and Contingencies
|
Shareholders’
Equity
|
9.
|
Subsequent
Events
|
·
|
Clinical trial expenses increased
by $732,397, to $733,434 from $1,037, primarily due to our close out of
our phase I trial in the Fiscal 2008
Quarter.
|
·
|
Wages, options and lab costs
increased by $119,419, or 97% to $242,960 from $123,541, primarily as a
result of the recording of $122,747 reversal of a salary bonus accrued but
not paid in Fiscal 2009 Quarter. No bonus accrual was recorded nor paid in
Fiscal 2010 Quarter.
|
·
|
Consulting expenses decreased by
$24,557, or 78%, to $7,013 from $31,570, primarily resulting from the fact
that no fees were paid in the Fiscal 2010 Quarter compared to the same
period last year, for a consultant’s agreement expired and lower option
expense.
|
·
|
Manufacturing expenses decreased
by $9,098, or 40% to $13,928 from $23,026, primarily as a result of the
completion of our clinical supply program for the upcoming clinical trials
prior to Fiscal 2010 Quarter compared to the manufacturing program which
was ongoing in the Fiscal 2009
Quarter.
|
·
|
Wages, Options and benefit
expenses increased by $46,991, or 20% to $280,252 from $233,262
principally due to the recording higher option expense of $71,552 due to
issuance of new options in Fiscal 2009 third Quarter and an adjustment of
$35,932 to bonus expenses caused by reversal of accrued for but not paid
in Fiscal 2009 Quarter. No bonus was accrued for in Fiscal 2010
Year. These higher expenses were partially offset by lower
compensation expenses: $55,000 due to an adjustment in the prior Fiscal
2009 Quarter and lower 401K expenses of
$8,360.
|
·
|
Consulting fees decreased by
$27,000 or 100%, to $0from $27,000. This decrease was due to the
expiration of our financial advisor agreement in Fiscal 2009
Quarter.
|
·
|
Offering expenses increased by
$4,016 or 18% to $26,097 from $22,081 primarily due to higher activity in
Fiscal 2010 Quarter compared to the same period in the prior
year.
|
·
|
An increase in legal, accounting,
professional and public relations expenses of $8,515, or 5%, to $177,399
from $168,884, primarily as a result of higher legal fees of $63,833 due
to the ongoing financial raises partially offset by lower patent expenses
of $42,487 and public relations of $10,757 in Fiscal 2010 Quarter compared
to Fiscal 2009 Quarter Overall the higher legal expense in Fiscal 2010
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 we decided to abandon in Fiscal 2009
Quarter.
|
·
|
Amortization of intangibles and
depreciation of fixed assets increased by $4,168, or 16%, to $30,679 from
$26,511 primarily due to an increase in fixed assets and intangibles in
the Fiscal 2010 Quarter compared to the Fiscal 2009
Quarter.
|
·
|
Overall occupancy and conference
related expenses increased by $6,860 or 10% to $74,577 from $67,717.
Overall conference expense has increased by $6,415 in the Fiscal 2010
Quarter due to higher participation in cancer conferences. Additional
expenses required in connection with the patent hearing in Fiscal 2009
Quarter were more than offset by lower dues and office expenses in the
Fiscal 2010 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.
|
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: March
19, 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
|