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 |
As of April 30,
|
||||||||
2010
|
2009
|
|||||||
Warrants
|
85,043,407 | 89,417,733 | ||||||
Stock
Options
|
18,119,090 | 8,812,841 | ||||||
Total
|
103,162,497 | 98,230,574 |
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
|