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
Sheets at July 31, 2010 (unaudited) and October 31, 2009
|
2
|
||
Statements
of Operations for the three and nine month periods ended July 31, 2010 and
2009 and the period March 1, 2002 (inception) to July 31, 2010
(unaudited)
|
3
|
||
Statements
of Cash Flow for the nine month periods ended July 31, 2010 and 2009 and
the period March 1, 2002 (inception) to July 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
|
13
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
18
|
|
Item
4.
|
Controls
and Procedures
|
18
|
|
PART
II
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
19
|
|
Item
1A.
|
Risk
Factors
|
19
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
20
|
|
Item
6.
|
Exhibits
|
20
|
|
SIGNATURES
|
22
|
July 31,
2010
|
October 31,
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$
|
26,274
|
$
|
659,822
|
||||
Prepaid
expenses
|
55,985
|
36,445
|
||||||
Total
Current Assets
|
82,259
|
696,267
|
||||||
Deferred
expenses
|
364,200
|
288,544
|
||||||
Property
and Equipment (net of accumulated depreciation)
|
37,096
|
54,499
|
||||||
Intangible
Assets (net of accumulated amortization)
|
2,044,065
|
1,371,638
|
||||||
Deferred
Financing Cost
|
299,493
|
|||||||
Other
Assets
|
51,963
|
3,876
|
||||||
Total
Assets
|
$
|
2,579,583
|
$
|
2,714,317
|
||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
2,323,383
|
2,368,716
|
|||||
Accrued
expenses
|
565,507
|
917,250
|
||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
891,806
|
2,078,851
|
||||||
Notes
payable – including interest payable
|
597,509
|
1,121,094
|
||||||
Total
Current Liabilities
|
4,378,205
|
6,485,911
|
||||||
Common
Stock Warrant
|
17,982,187
|
11,961,734
|
||||||
Total
Liabilities
|
$
|
22,360,392
|
$
|
18,447,645
|
||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred
Stock; issued and outstanding 500 at July 31, 2010 and 0 at October 31,
2009. Series A Preferred Stock; issued and outstanding 0 at July 31,
2010 and 0 at October 31, 2009
|
||||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 170,585,758 at July 31, 2010 and 115,638,243 at October 31,
2009
|
170,585
|
115,638
|
||||||
Additional
Paid-In Capital
|
14,039,517
|
754,834
|
||||||
Stock
subscription receivable
|
(6,250,970
|
)
|
||||||
Deficit
accumulated during the development stage
|
(27,739,941
|
) |
(16,603,800
|
)
|
||||
Total
Shareholders' Deficiency
|
$
|
(19,780,809
|
)
|
$
|
(15,733,328
|
)
|
||
Total
Liabilities and Shareholders’ Deficiency
|
$
|
2,579,583
|
$
|
2,714,317
|
Three Months Ended
July 31,
|
Nine Months Ended
July 31,
|
Period from
March 1, 2002
(Inception) to
July 31,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Revenue
|
$
|
176,768
|
$
|
(5,369
|
)
|
$
|
264,002
|
$
|
(5,369
|
)
|
$
|
1,618,864
|
||||||||
Research
& Development Expenses
|
847,995
|
476,421
|
2,930,033
|
939,407
|
13,103,574
|
|||||||||||||||
General
& Administrative Expenses
|
1,128,952
|
985,726
|
2,496,873
|
2,019,648
|
15,206,582
|
|||||||||||||||
Total
Operating expenses
|
1,976,947
|
1,462,147
|
5,426,906
|
2,959,055
|
28,310,156
|
|||||||||||||||
Loss
from Operations
|
(1,800,179
|
)
|
(1,467,516
|
)
|
(5,162,904
|
)
|
(2,964,424
|
)
|
(26,691,292
|
)
|
||||||||||
-
|
||||||||||||||||||||
-
|
||||||||||||||||||||
Interest
expense
|
(316,385
|
)
|
(374,563
|
)
|
(3,629,592
|
)
|
(410,615
|
)
|
(5,565,084
|
)
|
||||||||||
Interest
Income
|
31,287
|
-
|
48,088
|
294,554
|
||||||||||||||||
Gain
on note retirement
|
12,664
|
-
|
77,018
|
-
|
1,609,495
|
|||||||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
4,127,643
|
2,014,220
|
(2,747,729
|
) |
2,014,220
|
1,455,269
|
||||||||||||||
Net
Income (Loss) before benefit for income taxes
|
2,055,030
|
172,141
|
(11,415,119
|
)
|
(1,360,819
|
)
|
(28,897,058
|
)
|
||||||||||||
Income
tax benefit
|
-
|
-
|
278,978
|
922,020
|
1,201,001
|
|||||||||||||||
Net
Income (Loss)
|
2,055,030
|
172,141
|
(11,136,141
|
)
|
(438,799
|
)
|
(27,696,057
|
)
|
||||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
(43,884
|
)
|
||||||||||||||
Net
Income (Loss) applicable to Common Stock
|
$
|
2,055,030
|
$
|
172,141
|
$
|
(11,136,141
|
)
|
$
|
(438,799
|
)
|
$
|
(27,739,941
|
)
|
|||||||
Net
(Loss) per share, basic
|
$
|
0.01
|
$
|
0.00
|
$
|
(0.08
|
)
|
$
|
0.00
|
|||||||||||
Net
(Loss) per share, diluted
|
$
|
0.01
|
$
|
0.00
|
$
|
(0.08
|
)
|
$
|
0.00
|
|||||||||||
Weighted
average number of shares outstanding, basic
|
166,101,987
|
115,243,678
|
139,132,168
|
112,599,706
|
||||||||||||||||
Weighted
average number of shares, diluted
|
185,016,037
|
115,243,678
|
139,132,168
|
112,599,706
|
Nine Months Ended
July 31,
|
Period from
March 1, 2002
(Inception) to
July 31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
(11,136,141 | ) | (438,799 | ) | (27,696,057 | ) | ||||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and stock
|
472,215 | 372,695 | 2,896,970 | |||||||||
Amortization
of deferred financing costs
|
- | - | 260,000 | |||||||||
Amortization
of deferred expenses
|
169,344 | - | 230,800 | |||||||||
Amortization
of discount on Bridge Loans
|
528,989 | 37,231 | 652,835 | |||||||||
Impairment
of intangible assets
|
- | - | 26,087 | |||||||||
Non-cash
interest expense
|
3,084,821 | 345,044 | 4,301,657 | |||||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
2,747,728 | (2,014,220 | ) | (1,455,269 | ) | |||||||
Value
of penalty shares issued
|
- | - | 149,276 | |||||||||
Depreciation
expense
|
28,771 | 27,486 | 157,509 | |||||||||
Amortization
expense of intangibles
|
69,794 | 54,374 | 431,726 | |||||||||
Gain
on note retirement
|
(77,018 | ) | - | (1,609,495 | ) | |||||||
Decrease
(Increase) in prepaid expenses
|
(19,540 | ) | (1,243 | ) | (55,984 | ) | ||||||
Increase
in other assets
|
(45,824 | ) | - | (49,701 | ) | |||||||
Increase
in Deferred Expenses
|
- | (116,938 | ) | - | ||||||||
(Decrease)
increase in accounts payable
|
121,021 | 415,954 | 2,978,920 | |||||||||
(Decrease)
Increase in accrued expenses
|
(11,745 | ) | 112,541 | 465,873 | ||||||||
(Decrease)
in interest payable
|
(171,200 | ) | - | (152,909 | ) | |||||||
Net
cash used in operating activities
|
(4,238,785 | ) | (1,205,873 | ) | (18,467,762 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
- | (44,940 | ) | |||||||||
Purchase
of property and equipment
|
(11,369 | ) | - | (149,026 | ) | |||||||
Cost
of intangible assets
|
(672,220 | ) | (227,054 | ) | (2,506,829 | ) | ||||||
Net
cash used in Investing Activities
|
(683,589 | ) | (227,054 | ) | (2,700,795 | ) | ||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
- | 960,000 | ||||||||||
Cash
paid for deferred financing costs
|
(559,493 | ) | ||||||||||
Principal
payment on notes payable
|
(1,384,001 | ) | (12,320 | ) | (1,507,592 | ) | ||||||
Proceeds
from notes payable
|
1,015,000 | 1,434,635 | 6,020,859 | |||||||||
Net
proceeds of issuance of Preferred Stock
|
4,487,827 | - | 4,722,827 | |||||||||
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
|
$ | 4,288,826 | $ | 1,422,315 | $ | 21,194,831 | ||||||
Net
(Decrease) increase in cash
|
(633,548 | ) | (10,612 | ) | 26,274 | |||||||
Cash
at beginning of period
|
659,822 | 59,738 | - | |||||||||
Cash
at end of period
|
$ | 26,274 | $ | 49,126 | $ | 26,274 |
Nine Months Ended
July 31,
|
Period from
March 1, 2002
(Inception)
to July 31
|
|||||||||||
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
|
-
|
$
|
||||||||||
Notes
payable and embedded derivative liabilities converted to Common
Stock
|
$
|
3,322,092
|
-
|
$
|
5,835,250
|
|||||||
Intangible
assets acquired with notes payable
|
-
|
-
|
$
|
360,000
|
||||||||
Intangible
assets acquired with Common Stock
|
$ |
70,000
|
-
|
70,000
|
||||||||
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
|
$
|
6,250,970
|
-
|
$
|
6,250,970
|
|||||||
Warrants
Issued in connection with issuance of Common Stock
|
-
|
$
|
1,505,550
|
|||||||||
Warrants
issued in connection with issuances of Preferred stock
|
-
|
$
|
3,587,625
|
As of July 31,
|
||||||||
2010
|
2009
|
|||||||
Warrants
|
40,550,218
|
89,143,801
|
||||||
Stock
Options
|
-
|
17,962,841
|
||||||
Total
|
40,550,218
|
107,106,642
|
July 31,
2010
|
October 31,
2009
|
|||||||
License
|
$
|
651,992
|
$
|
571,275
|
||||
Patents
|
1,741,803
|
1,080,299
|
||||||
Total
intangibles
|
2,393,795
|
1,651,574
|
||||||
Accumulated
Amortization
|
(349,730
|
) |
(279,936
|
) | ||||
Intangible
Assets
|
$
|
2,044,065
|
$
|
1,371,638
|
Bridge
Note – Principal Value - Issued
|
$
|
4,474,601
|
||
Principal
payments on Bridge Notes
|
(1,128,413
|
)
|
||
Bridge
Note Conversions
|
(2,420,373
|
)
|
||
Original
Issue Discount, net of accreted interest
|
(17,532
|
)
|
||
Fair
Value of Attached Warrants at issuance
|
(1,580,247
|
)
|
||
Fair
Value of Embedded Derivatives at issuance
|
(2,430,858
|
)
|
||
Accreted
interest on embedded derivative and warrant liabilities
|
3,892,195
|
|||
Convertible
Bridge Notes- as of July 31, 2010
|
$
|
789,373
|
||
Embedded
Derivatives Liability at July 31, 2010
|
102,433
|
|||
Convertible Bridge
Notes and fair value of embedded derivative
|
$
|
891,806
|
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
|
||||||||
Issuance
of Optimus Warrants
|
6,856,946
|
|||||||||||||||
Bridge
Note Conversions
|
(2,420,373
|
)
|
(701,718
|
)
|
||||||||||||
Change
in fair value
|
(3,866,801
|
)
|
(260,843
|
)
|
||||||||||||
Accreted
interest
|
(50,842
|
)
|
||||||||||||||
Exercise
of common stock warrants
|
(1,475,758
|
)
|
||||||||||||||
Note
Payoffs
|
(88,236
|
)
|
(12,665
|
)
|
||||||||||||
Total
Valuation as of July 31, 2010
|
$
|
925,815
|
$
|
17,532
|
$
|
17,982,187
|
$
|
102,433
|
Type
|
Exercise
Price
|
Amount
|
Expiration Date
|
Type of Financing
|
||||
Common
Stock Purchase Warrant
|
$0.17
– 0.287
|
65,049,197
|
February
2011 – October 2012
|
2007
Securities Purchase Agreement
|
||||
Common
Stock Purchase Warrant
|
$0.17
|
12,387,210
|
June
2014 – April 2015
|
Bridge
Notes
|
||||
Subtotal
|
77,436,407
|
|||||||
Common
Stock Purchase
Warrant
|
$0.18
|
2,818,000
|
September
2012
|
Optimus
Preferred Stock Agreement (9/24/2009)
|
||||
Common
Stock Purchase Warrant
|
TBD
(1)
|
40,500,000
|
July
2013
|
Optimus
Preferred Stock Agreement (7/19/2010)
|
||||
Grand
Total
|
120,754,407
|
For the nine months ending
July 31
|
||||||||
2010
|
2009
|
|||||||
Research
and development
|
$
|
115,285
|
$
|
143,486
|
||||
General
and Administrative
|
318,091
|
202,984
|
||||||
Total
stock compensation expense recognized
|
$
|
433,376
|
$
|
346,470
|
|
·
|
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.
|
3.1(i)
|
Amended
and Restated Certificate of Incorporation. Incorporated by reference to
Annex C to DEF 14A Proxy Statement filed with the SEC on May 15,
2006.
|
|
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 September 13,
2006.
|
|
10.1*
|
Separation
Agreement and General Release dated January 6, 2010 between the Company
and Fred Cobb.
|
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: September
14, 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
|