x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o
|
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
|
|
841521955
|
(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
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(Issuer’s
telephone number)
|
(Former
name, former address and former fiscal year, if changed since last
report)
|
|
Page
No.
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|
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2
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3
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4
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6
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8
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11
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11
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11
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12
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January
31, 2008
|
|||
ASSETS
|
||||
Current
Assets:
|
||||
Cash
|
$
|
2,826,873
|
||
Prepaid
expenses
|
147,873
|
|||
Total Current Assets
|
2,974,746
|
|||
|
||||
Property
and Equipment (net of accumulated depreciation of $64,747)
|
114,617
|
|||
Intangible
Assets (net of accumulated amortization of $164,990)
|
1,125,111
|
|||
Other
Assets
|
3,876
|
|||
Total Assets
|
$
|
4,218,350
|
||
LIABILITIES
& SHAREHOLDERS’ EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
801,340
|
||
Accrued
expenses
|
426,664
|
|||
Deferred
revenue
|
52,597
|
|||
Interest
payable
|
14,568
|
|||
Notes
payable - current portion
|
66,850
|
|||
Total
Current Liabilities
|
1,362,019
|
|||
|
||||
Notes
payable - net of current portion
|
16,098
|
|||
Total
Liabilities
|
$
|
1,378,117
|
||
|
||||
Shareholders’
Equity:
|
||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and oustanding | - | |||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 107,957,977
|
107,957
|
|||
Additional
Paid-In Capital
|
16,250,525
|
|||
Deficit
accumulated during the development stage
|
(13,518,249
|
)
|
||
Total
Shareholders' Equity
|
$
|
2,840,233
|
||
Total Liabilities & Shareholders’ Equity
|
$
|
4,218,350
|
|
3
Months
Ended
January
31,
|
3
Months
Ended
January
31,
|
Period
from
March
1, 2002 (Inception) to
January
31,
|
|||||||
|
2008
|
2007
|
2008
|
|||||||
Revenue
|
$
|
22,403
|
$
|
146,307
|
$
|
1,281,839
|
||||
|
||||||||||
Research
& Development Expenses
|
682,163
|
494,107
|
6,058,307
|
|||||||
General
& Administrative Expenses
|
772,590
|
845,072
|
7,745,477
|
|||||||
Total
Operating expenses
|
1,454,752
|
1,339,179
|
13,803,784
|
|||||||
|
||||||||||
Loss
from Operations
|
(1,432,350
|
)
|
(1,192,872
|
)
|
(12,521,944
|
)
|
||||
|
||||||||||
Other
Income (expense):
|
||||||||||
Interest
expense
|
(1,987
|
)
|
(153,355
|
)
|
(1,075,207
|
)
|
||||
Other
Income
|
32,714
|
26,326
|
232,542
|
|||||||
Gain
on note retirement
|
-
|
-
|
1,532,477
|
|||||||
Net
changes in fair value of common stock warrant
liability and embedded derivative liability
|
-
|
1,282,871
|
(1,642,232
|
)
|
||||||
Net
loss
|
(1,401,623
|
)
|
(37,030
|
)
|
(13,474,365
|
)
|
||||
|
||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
43,884
|
|||||||
|
||||||||||
Net
loss applicable to Common Stock
|
(1,401,623
|
)
|
$
|
(37,030
|
)
|
$
|
(13,518,249
|
)
|
||
|
||||||||||
Net
loss per share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
||||
|
||||||||||
Weighted
average number of shares outstanding basic and diluted
|
107,957,977
|
41,168,537
|
|
3
Months ended
January
31,
|
3
Months ended
January
31,
|
Period
from
March
1, 2002 (Inception)
to
January
31,
|
|||||||
|
2008
|
2007
|
2008
|
|||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(1,401,623
|
)
|
$
|
(37,030
|
)
|
$
|
(13,474,365
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
51,889
|
392,439
|
1,549,755
|
|||||||
Amortization
of deferred financing costs
|
-
|
29,606
|
260,000
|
|||||||
Non-cash
interest expense
|
1,007
|
82,399
|
511,285
|
|||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
-
|
(1,282,871
|
)
|
1,642,232
|
||||||
Value
of penalty shares issued
|
-
|
-
|
117,498
|
|||||||
Depreciation
expense
|
8,794
|
6,334
|
64,747
|
|||||||
Amortization
expense of intangibles
|
15,858
|
13,241
|
168,161
|
|||||||
Gain
on note retirement
|
-
|
-
|
(1,532,477
|
)
|
||||||
Decrease
(Increase) in prepaid expenses
|
52,044
|
21,382
|
(147,873
|
)
|
||||||
Decrease
(Increase) in other assets
|
-
|
724
|
(3,876
|
)
|
||||||
Increase
in accounts payable
|
14,043
|
3,447
|
1,238,546
|
|||||||
Increase
in accrued expenses
|
121,641
|
6,047
|
410,475
|
|||||||
Increase
in interest payable
|
-
|
40,518
|
18,291
|
|||||||
Increase
(Decrease) in deferred revenue
|
52,597
|
(12,456
|
)
|
52,597
|
||||||
Net
cash used in operating activities
|
(1,088,750
|
)
|
(736,220
|
)
|
(9,125,003
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(6,969
|
)
|
(29,400
|
)
|
(133,784
|
)
|
||||
Cost
of intangible assets
|
(42,834
|
)
|
(16,674
|
)
|
(1,368,223
|
)
|
||||
Net
cash used in Investing Activities
|
(49,803
|
)
|
(46,074
|
)
|
(1,546,947
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
960,000
|
|||||||||
Cash
paid for deferred financing costs
|
-
|
(260,000
|
)
|
|||||||
Principal
Payments on notes payable
|
(3,546
|
)
|
(1,063
|
)
|
(95,633
|
)
|
||||
Proceeds
from notes payable
|
-
|
1,271,224
|
)
|
|||||||
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
|
)
|
-
|
11,988,232
|
||||||
Net
cash (used in) provided by Financing Activities
|
(81,558
|
)
|
(1,063
|
)
|
13,498,823
|
|||||
Net
(Decrease) increase in cash
|
(1,215,111
|
)
|
(783,357
|
)
|
2,826,873
|
|||||
Cash
at beginning of period
|
4,041,984
|
2,761,166
|
-
|
|||||||
Cash
at end of period
|
$
|
2,826,873
|
$
|
1,977,809
|
$
|
2,826,873
|
|
3
Months ended
January
31,
|
3
Months ended
January
31,
|
Period
from
March
1, 2002
(Inception)
to
January
31,
|
|||||||
2008
|
2007
|
2008
|
||||||||
Equipment
acquired under capital lease
|
$
|
—
|
$
|
45,580
|
$
|
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
|
||||||
Notes
payable and accrued interest converted to Common Stock
|
$
|
$150,000
|
$
|
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
|
—
|
—
|
1,505,550
|
1.
|
Business
description
|
Intangible
Assets:
|
|
October
31, 2007
|
January 31, 2008
|
Increase/Decrease
|
|||||||
Trademark
|
$
|
87,857
|
$
|
90,714
|
$
|
2,857
|
||||
License
|
496,127
|
529,915
|
33,788
|
|||||||
Patents
|
663,283
|
669,472
|
6,189
|
|||||||
Total
intangibles
|
1,247,267
|
1,292,101
|
42,834
|
|||||||
Accumulated
Amortization
|
(149,132
|
)
|
(164,990
|
)
|
(15,858
|
)
|
||||
Intangible
Assets
|
$
|
1,098,135
|
$
|
1,125,111
|
$
|
26,976
|
Loss
Per Share:
|
As
of
January
31, 2007
|
As
of
January
31, 2008
|
||||||
Warrants
|
25,009,220
|
87,713,770
|
|||||
Stock
Options
|
8,126,123
|
8,512,841
|
|||||
Convertible
Debt (1)
|
17,317,487
|
||||||
Total
All
|
50,452,830
|
96,226,611
|
Uncertain
Tax Provisions:
|
|
Secured
Convertible Debenture:
|
·
|
Clinical
trial expenses decreased by $63,281, or 49%, to $66,621 from $129,902
due
to our higher clinical trial activity in the Fiscal 2007 Quarter
compared
to the close out phase in the Fiscal 2008 Quarter.
|
·
|
Wages,
options and lab costs increased by $28,720, or 11% to $283,858 from
$255,138 principally due to our expanded research & development
efforts and a wage increase on November 1, 2007.
|
·
|
Consulting
expenses increased by $23,799, or 152%, to $39,411 from $15,612,
primarily
reflecting the higher effort required to prepare the Investigational
New
Drug filing for the FDA in the Fiscal 2008 Quarter compared to the
same
period last year.
|
·
|
Subcontracted
research expenses decreased by $50,644, or 55%, to $41,225 from $91,869,
primarily reflecting the reduced subcontract work performed by Dr.
Paterson at Penn, pursuant to the NCI grants in the first quarter
Fiscal
2008 Quarter compared to the same period last year.
|
·
|
Manufacturing
expenses increased by $222,822, to $224,407 from $1,585; the result
of the
ongoing clinical supply program for our upcoming Phase II trial compared
to no manufacturing program in the Fiscal 2007 Quarter.
|
·
|
Toxicology
study expenses of $26,640, incurred in the Fiscal 2008 Quarter, are
a
result of an ongoing toxicology study by Pharm Olam in connection
with our
Lovaxin C product candidates in anticipation of clinical studies
in 2008,
no such expenses were incurred in the Fiscal 2007
Quarter.
|
·
|
Wages,
Options and benefit expenses increased by $138,158, or 84% to $301,814
from $163,656 due to the effect of hiring the Chief Executive Officer
(“CEO”)
midway
through the Fiscal 2007 Quarter compared to his employment for the
full
Fiscal 2008 Quarter. He also received an annual pay increase of $100,000
due to a successful milestone on October 17, 2007. Additionally there
were
other wage increases on November 1, 2007. An increase of option expense
of
$32,876 to $52,650, or 166% from $19,774 is primarily due to the
CEO’s
options granted as part of his employment agreement. In Fiscal 2008
Quarter the expense included three months of vesting versus one month
in
the Fiscal 2007 Quarter.
|
·
|
Consulting
fees and expenses decreased by $358,029, or 74%, to $125,646 from
$483,675. This decrease was primarily attributed to: (i) a decrease
of $159,909 in option expense recorded in the Fiscal 2007 Quarter
primarily due to an amendment of Mr. Appel’s (LVEP) consulting agreement
compared to no options recorded in the Fiscal Quarter 2008; (ii)
a
decrease of $204,852 primarily due to the issuance to Mr. Appel of
1,000,000 shares of common stock of the Company ($200,000) and (iii)
a
$41,667 decrease of Mr. Appel’s bonus recorded in the Fiscal 2007 Quarter
and none recorded in the Fiscal 2008 Quarter. These decreases in
expenses
were partially offset by the increase in other consulting expenses
due to
financial advisor fees of $48,399 recorded in the Fiscal 2008 Quarter
verses the fees for other consultants in the Fiscal 2007
Quarter.
|
·
|
Penalty expense
increased by $31,778 to $31,778. This expense 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.
|
·
|
An
increase in legal, accounting, professional and public relations
expenses
of $76,238, or 66%, to $191,205 from $114,967, primarily as a result
of
growth in the Company and additional cost of being a public
company.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $5,077,
or
26%, to $24,652 from $19,575 primarily due to an increase in fixed
assets
and intangibles in the Fiscal 2008 Quarter compared to the Fiscal
2007
Quarter.
|
·
|
Overall
occupancy and conference related expenses increased by $34,296 or
54% to
$97,495 from $63,199. Overall conference expense has increased by
$30,960
in the Fiscal 2008 Quarter due to the participation in several cancer
conferences. Additional expenses for publication material were partially
offset by lower director and officer’s insurance costs amounting to $8,728
for the Fiscal 2008 Quarter.
|
|
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 November 27, 2007 relating to items:4.01 and
9.01.
|
ADVAXIS,
INC.
Registrant
|
||
|
|
|
Date: March
17, 2008
|
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
|
||
1.
|
I
have reviewed this report on Form 10-QSB for the quarter ended January
31,
2008 of Advaxis, Inc.; (the “small business
issuer”);
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
small
business issuer as of, and for, the periods presented in this
report;
|
4.
|
The
small business issuer’s other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e) for the small
business issuer and have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the small business issuer,
including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
|
(b)
|
Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation;
and
|
(c)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business
issuer’s
most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the small business issuer’s internal control
over financial reporting; and
|
5.
|
The
small business issuer’s other certifying officer and I have disclosed,
based on our most recent evaluation of internal control over financial
reporting, to the small business issuer’s auditors and the audit committee
of the small business issuer’s board of directors (or persons performing
the equivalent functions):
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer’s ability
to record, process, summarize and report financial information;
and
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
|
|
|
|
|
March
17, 2008
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Thomas
Moore
|
|
|
|
Name:
Thomas Moore
|
|
|
|
Title:
Chief Executive Officer
|
|
|
|
1.
|
I
have reviewed this report on Form 10-QSB for the quarter ended January
31,
2008 of Advaxis, Inc.; (the “small business
issuer”);
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
small
business issuer as of, and for, the periods presented in this
report;
|
4.
|
The
small business issuer’s other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e) for the small
business issuer and have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the small business issuer,
including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
|
(b)
|
Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation;
and
|
(c)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business
issuer’s
most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the small business issuer’s internal control
over financial reporting; and
|
5.
|
The
small business issuer’s other certifying officer and I have disclosed,
based on our most recent evaluation of internal control over financial
reporting, to the small business issuer’s auditors and the audit committee
of the small business issuer’s board of directors (or persons performing
the equivalent functions):
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer’s ability
to record, process, summarize and report financial information;
and
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
|
March
17, 2008
|
|
|
|
|
|
|
|
|
|
|
|
/s
/ Fredrick Cobb
|
|
|
|
Name:
Fredrick Cobb
|
|
|
|
Title:
Vice President Finance, Principal Financial Officer
|
|
|
|
(1)
|
Fully
complies with the requirements of section 13 (a) or 15 (d) of the
Securities Exchange Act of 1934;
and
|
(2)
|
Fairly
presents, in all material respects, the financial condition and result
of
operations of the Company.
|
March
17, 2008
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Thomas
Moore
|
|
|
|
Thomas
Moore
|
|
|
|
Chief
Executive Officer
|
|
|
|
(1)
|
Fully
complies with the requirements of section 13 (a) or 15 (d) of the
Securities Exchange Act of 1934;
and
|
(2)
|
Fairly
presents, in all material respects, the financial condition and result
of
operations of the Company.
|
March
17, 2008
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Fredrick
Cobb
|
|
|
|
Fredrick
Cobb
|
|
|
|
Vice
President Finance, Principal Financial Officer
|
|
|
|