|
OMB
APPROVAL
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OMB
Number: 3235-0416
Expires:
April 30, 2010
Estimated
Average burden
Hours
per response
182
|
x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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Delaware
|
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02-0563870
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(State
or other jurisdiction of incorporation or organization)
|
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(IRS
Employer Identification No.)
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Page
No.
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Item
1. Condensed Financial Statements
|
|
|
|
Balance
Sheet at April 30, 2008 (unaudited)
|
3
|
|
|
Statements
of Operations for the three and six month periods ended April 30,
2008 and
2007 (unaudited), and the period March 1, 2002 (inception) to April
30,
2008 (unaudited)
|
4
|
|
|
Statement
of Cash Flows Statements for the six month periods ended April 30,
2008
and 2007 and the period March 1, 2002 (inception) to April 30, 2008
(unaudited)
|
5
|
|
|
Notes
to Condensed Financial Statements
|
7
|
|
|
Item
2. Management’s Discussion and Analysis
|
9
|
|
|
Item
3. Controls and Procedures
|
13
|
|
|
|
|
|
|
13
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|
|
|
13
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|
|
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14
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CERTIFICATIONS
|
|
|
April
30,
2008
|
|||
Current
Assets:
|
||||
Cash
|
$
|
1,295,708
|
||
Prepaid
expenses
|
135,975
|
|||
Total Current Assets
|
1,431,683
|
|||
|
||||
Property
and Equipment (net of accumulated depreciation of $73,789)
|
108,527
|
|||
Intangible
Assets (net of accumulated amortization of $183,476)
|
1,182,938
|
|||
Other
Assets
|
3,876
|
|||
|
||||
Total
Assets
|
$
|
2,727,024
|
||
LIABILITIES
& SHAREHOLDERS’ EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
802,045
|
||
Accrued
expenses
|
324,028
|
|||
Deferred
revenue
|
34,641
|
|||
Interest
payable
|
14,568
|
|||
Notes
payable - current portion
|
67,835
|
|||
Total
Current Liabilities
|
1,243,117
|
|||
|
||||
Notes
payable - net of current portion
|
12,446
|
|||
Total
Liabilities
|
1,255,563
|
|||
Shareholders’
Equity:
|
||||
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 109,073,676 shares
|
109,073
|
|||
Additional
Paid-In Capital
|
16,489,917
|
|||
Deficit
accumulated during the development stage
|
(15,127,529
|
)
|
||
Total
Shareholders' Equity
|
1,471,461
|
|||
Total
Liabilities and Shareholders’ Equity
|
$
|
2,727,024
|
|
3 Months
Ended
April 30,
2008
|
3 Months
Ended
April 30,
2007
|
6 Months
Ended
April 30,
2008
|
6 Months
Ended
April 30,
2007
|
Period from
March 1, 2002
(Inception) to
April 30,
2008
|
|||||||||||
Revenue
|
$
|
17,956
|
$
|
7,894
|
$
|
40,359
|
$
|
154,201
|
$
|
1,299,795
|
||||||
|
||||||||||||||||
Research
& Development Expenses
|
664,875
|
530,492
|
1,347,038
|
1,024,599
|
6,723,182
|
|||||||||||
General
& Administrative Expenses
|
971,530
|
1,002,829
|
1,744,120
|
1,847,901
|
8,717,007
|
|||||||||||
Total
Operating expenses
|
1,636,405
|
1,533,321
|
3,091,158
|
2,872,500
|
15,440,189
|
|||||||||||
|
||||||||||||||||
Loss
from Operations
|
(1,618,449
|
)
|
(1,525,427
|
)
|
(3,050,799
|
)
|
(2,718,299
|
)
|
(14,140,394
|
)
|
||||||
|
||||||||||||||||
Other
Income (expense):
|
||||||||||||||||
Interest
expense
|
(1,945
|
)
|
(212,181
|
)
|
(3,931
|
)
|
(365,536
|
)
|
(1,077,151
|
)
|
||||||
Other
Income
|
11,114
|
11,646
|
43,827
|
37,972
|
243,656
|
|||||||||||
Gain
on note retirement
|
-
|
319,967
|
-
|
319,967
|
1,532,477
|
|||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
-
|
(1,729,549
|
)
|
(446,678
|
)
|
(1,642,232
|
)
|
|||||||||
Net
loss
|
(1,609,280
|
)
|
(3,135,544
|
)
|
(3,010,903
|
)
|
(3,172,574
|
)
|
(15,083,645
|
)
|
||||||
|
||||||||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
43,884
|
|||||||||||
|
||||||||||||||||
Net
loss applicable to Common Stock
|
$
|
(1,609,280
|
)
|
$
|
(3,135,544
|
)
|
$
|
(3,010,903
|
)
|
$
|
(3,172,574
|
)
|
$
|
(15,127,529
|
)
|
|
|
||||||||||||||||
Net
loss per share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.07
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
||||
|
||||||||||||||||
Weighted
average number of shares outstanding, basic and diluted
|
108,428,587
|
43,714,807
|
108,190,696
|
42,385,001
|
6
Months
ended
April
30,
|
6
Months
ended
April
30,
|
Period
from
March 1, 2002
(Inception) to
April 30,
|
||||||||
2008
|
2007
|
2008
|
||||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(3,010,903
|
)
|
$
|
(3,172,574
|
)
|
$
|
(15,083,645
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
net cash used in operating activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
260,620
|
999,931
|
1,758,486
|
|||||||
Amortization
of deferred financing costs
|
-
|
79,972
|
260,000
|
|||||||
Non-cash
interest expense
|
1,994
|
206,681
|
512,272
|
|||||||
Accrued
interest on notes payable
|
-
|
76,457
|
-
|
|||||||
Loss
on change in value of warrants and embedded derivative
|
-
|
446,678
|
1,642,232
|
|||||||
Value
of penalty shares issued
|
31,778
|
-
|
149,276
|
|||||||
Depreciation
expense
|
17,836
|
14,629
|
73,789
|
|||||||
Amortization
expense of intangibles
|
34,344
|
28,878
|
186,647
|
|||||||
Gain
on note retirement
|
-
|
(319,967
|
)
|
(1,532,477
|
)
|
|||||
Decrease
(Increase) in prepaid expenses
|
63,942
|
(11,780
|
)
|
(135,975
|
)
|
|||||
Decrease
(Increase) in other assets
|
-
|
725
|
(3,876
|
)
|
||||||
Increase
(Decrease) in accounts payable
|
14,748
|
(83,403
|
)
|
1,239,251
|
||||||
(Decrease)
Increase in accrued expenses
|
19,005
|
(31,993
|
)
|
307,841
|
||||||
Increase
in interest payable
|
-
|
-
|
18,291
|
|||||||
Increase
(Decrease) in deferred revenue
|
34,641
|
(20,350
|
)
|
34,641
|
||||||
Net
cash used in operating activities
|
(2,531,995
|
)
|
(1,786,116
|
)
|
(10,573,247
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(9,921
|
)
|
(32,873
|
)
|
(136,736
|
)
|
||||
Cost
of intangible assets
|
(119,147
|
)
|
(48,469
|
)
|
(1,444,537
|
)
|
||||
Net
cash used in investing Activities
|
(129,068
|
)
|
(81,342
|
)
|
(1,626,213
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
-
|
-
|
960,000
|
|||||||
Cash
paid for deferred financing costs
|
-
|
-
|
(260,000
|
)
|
||||||
Principal
payment on notes payable
|
(7,200
|
)
|
-
|
(99,287
|
)
|
|||||
Proceeds
from notes payable
|
-
|
(4,311
|
)
|
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
|
(78,013
|
)
|
-
|
11,988,231
|
||||||
Net
cash provided by (used in) financing Activities
|
(85,213
|
)
|
(4,311
|
)
|
13,495,168
|
|||||
Net
(Decrease) increase in cash
|
(2,746,276
|
)
|
(1,871,769
|
)
|
1,295,708
|
|||||
Cash
at beginning of period
|
4,041,984
|
2,761,166
|
-
|
|||||||
Cash
at end of period
|
$
|
1,295,708
|
$
|
889,397
|
$
|
1,295,708
|
|
6 Months
ended
April 30,
|
6 Months
ended
April 30,
|
Period from
March 1, 2002
(Inception) to
|
|||||||
|
2008
|
2007
|
April 30, 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
|
-
|
$
|
610,836
|
$
|
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 issuances of common stock
|
-
|
-
|
1,505,550
|
1.
|
Business
description
|
|
Intangible
Assets:
|
|
October 31, 2007
|
|
April 30, 2008
|
|
Increase (Decrease)
|
|||||
Trademark
|
$
|
87,857
|
$
|
94,912
|
$
|
7,055
|
||||
License
|
496,127
|
529,915
|
33,788
|
|||||||
Patents
|
663,283
|
741,587
|
78,304
|
|||||||
Total
intangibles
|
1,247,267
|
1,366,414
|
119,147
|
|||||||
Accumulated
Amortization
|
(149,132
|
)
|
(183,476
|
)
|
(34,344
|
)
|
||||
Intangible
Assets
|
$
|
1,098,135
|
$
|
1,182,938
|
$
|
84,803
|
|
Loss
Per Share:
|
As of
April 30, 2007
|
|
As of
April 30, 2008
|
|||||
Warrants
|
25,009,220
|
87,883,769
|
|||||
Stock
Options
|
8,512,841
|
8,812,841
|
|||||
Convertible
Debt (1)
|
7,861,189
|
-
|
|||||
Total
All
|
41,383,250
|
96,696,610
|
|
Uncertain
Tax Provisions:
|
|
Secured
Convertible Debenture:
|
·
|
Clinical
trial expenses decreased by $128,370, or 79%, to $34,123 from $162,493
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 $96,054, or 50% to $288,152 from
$192,098 principally due to our expanded research & development
efforts, the hiring of an Executive Director of Product Development,
a
wage increase on November 1, 2007 and a small increase in
bonus.
|
·
|
Consulting
expenses decreased by $68,959, or 59%, to $47,112 from $116,071,
primarily
reflecting lower stock option expenses in Fiscal 2008 Quarter compared
to
higher stock prices and option expenses in the same period last
year.
|
·
|
Subcontracted
research expenses increased by $17,710, or 80%, to $39,900 from $22,190,
primarily reflecting the increased subcontract work performed by
Dr.
Paterson at Penn, pursuant to the our sponsored research agreement
in the
second quarter Fiscal 2008 Quarter compared to the same period last
year.
|
·
|
Manufacturing
expenses increased by $255,588, to $255,588 from $0; the result of
the
ongoing clinical supply program for our upcoming Phase II trial in
the
Fiscal 2008 Quarter compared to no manufacturing program in the Fiscal
2007 Quarter.
|
·
|
Toxicology
study expenses decreased by $37,640, to $0 due to expenses incurred
in the
Fiscal 2007 Quarter as a result of a 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
2008 Quarter.
|
·
|
Wages,
Options and benefit expenses increased by $102,566, or 41% to $355,407
from $252,841 primarily due to the increase of the Chief Executive
Officer’s (“CEO”) base pay ($25,000) and stock compensation ($71,250) per
his employment agreement and overall higher wages for employees due
to a
wage increase on November 1, 2007.
|
·
|
Consulting
fees and expenses decreased by $284,901, or 58%, to $206,590 from
$491,491. This decrease was primarily attributed to an amendment to
Mr. Appel’s (LVEP Management, LLC (“LVEP”)) consulting agreement in the
Fiscal 2007 Quarter partially offset by a settlement agreement in
the
Fiscal 2008 Quarter which resulted in: (i) a decrease of $406,657
in
option expense recorded in the Fiscal 2007 Quarter primarily due
to an
amendment of Mr. Appel’s (LVEP) consulting agreement compared to no option
expense recorded in the Fiscal Quarter 2008, (ii) a net decease of
$78,125
in of Mr. Appel’s consulting expenses recorded in the Fiscal 2008 Quarter
and compared to those recorded in the Fiscal 2007 Quarter, partially
offset by (iii) his $130,000 settlement payment in the Fiscal 2008
Quarter
in cash and $14,615 in shares of common stock of the Company as part
of a
settlement agreement in the Fiscal 2008 Quarter. Mr. Appel’s net decreases
(i-iii) were also partially offset by increases in other consulting
expenses due to higher financial advisor fees of $66,600 recorded
in the
Fiscal 2008 Quarter verses the fees for other consultants in the
Fiscal
2007 Quarter.
|
·
|
Legal,
accounting, professional and public relations expenses decreased
by
$49,097, or 30%, to $116,368 from $165,465, due to higher patent
and
accounting expenses offset by fewer security filings in the Fiscal
2008
Quarter versus the Fiscal 2007 Quarter.
|
·
|
Recruiting
fees for the Executive Director of Product Development in the Fiscal
2008
Quarter increased by $62,295 to $63,395 versus $1,100 compared to
the
Fiscal 2007 Quarter.
|
·
|
Analysis
research cost increased by $97,750 to $97,990 from $240. This increase
consists of $55,240 in warrant expense recorded based on the Black-Scholes
calculation with the balance being payments for fees and printing
for the
Crystal Research Report.
|
·
|
Overall
occupancy, investor conference and related travel expenses in Fiscal
2008
Quarter increased by $36,493 or 54% from $67,759 to $104,252 primarily
due
to higher attendance at scientific and investor conferences compared
to
the Fiscal 2007 Quarter.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $3,596,
or
15%, to $27,528 from $23,932 primarily due to an increase in fixed
assets
and intangibles in the Fiscal 2008 Quarter compared to the Fiscal
2007
Quarter.
|
·
|
Clinical
trial expenses decreased by $191,651, or 66%, to $100,744 from $292,395
due to our higher clinical trial activity in the Fiscal 2007 Period
compared to the close out phase in the Fiscal 2008
Period.
|
·
|
Wages,
options and lab costs increased by $124,774, or 28% to $572,010 from
$447,236 principally due to our expanded research & development
efforts, the hiring of an Executive Director of Product Development,
a
wage increase on November 1, 2007 and an increase in
bonuses.
|
·
|
Consulting
expenses decreased by $45,160, or 34%, to $86,523 from $131,683,
primarily
reflecting lower stock option expenses in the Fiscal 2008 Period
compared
to higher stock prices and option expense in the same period last
year
partially offset by higher IND consulting expenses in the Fiscal
2008
Period as compared to the same period last year.
|
·
|
Subcontracted
research expenses decreased by $32,935, or 29%, to $81,124 from $114,059,
primarily reflecting the decreased subcontract work performed by
Dr.
Paterson at Penn, pursuant to our sponsored research agreement in
the
Fiscal 2008 Period compared to the same period last
year.
|
·
|
Manufacturing
expenses increased by $478,410 to $479,995 from $1,585 as a result
of the
ongoing clinical supply program for our upcoming Phase II trial compared
to no manufacturing program in the Fiscal 2007 Period.
|
·
|
Toxicology
study expenses decreased by $11,000, or 29% to $26,640 from $37,640
due to
expenses incurred in the Fiscal 2007 Period as a result of a 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 2008 Period.
|
·
|
Wages,
Options and benefit expenses increased by $240,724, or 58% to $657,221
from $416,497 primarily due to the increase of the CEO’s base pay
($50,000) and stock compensation ($71,250) per his employment agreement
and overall higher wages for employees due to a wage increase on
November
1, 2007.
|
·
|
Consulting
fees and expenses decreased by $642,929, or 66%, to $332,237 from
$975,166. This decrease was primarily attributed to an amendment to
Mr. Appel’s (LVEP) consulting agreement in the Fiscal 2007 Period
partially offset by a settlement agreement in the Fiscal 2008 Period
which
resulted in: (i) a decrease of $566,566 in option expense recorded
primarily due to an amendment of Mr. Appel’s consulting agreement compared
to no option expense recorded in the Fiscal 2008 Period; (ii) a decrease
of $200,000 primarily due to the issuance to Mr. Appel of 2 million
shares
in the Fiscal 2007 Period also due to the amendment, (iii) a net
decrease
of $100,497 in Mr. Appel’s consulting expenses recorded in the Fiscal 2008
Period compared to the Fiscal 2007 Period and (iv) a decrease of
$41,667
in Mr. Appel’s bonus accrual in the Fiscal 2007 Period partially offset by
(v) his $130,000 settlement payment in cash in the Fiscal 2008 Period
along with a $14,615 payment in shares of the Company. Mr. Appel’s net
decreases (i-v) were partially offset by the increase in other consulting
expenses due to higher financial advisor fees of $137,371 recorded
in the
Fiscal 2008 Periods verses the fees for other consultants in the
Fiscal
2007 Period.
|
·
|
Legal,
accounting, professional and public relations expenses increased
by
$7,142, or 3%, to $287,573 from $280,431, primarily as a result of
higher
patent and accounting expense partially offset by fewer security
filings
in the Fiscal 2008 Period versus the Fiscal 2007
Period.
|
·
|
Recruiting
fees for the Executive Director of Product Development in the Fiscal
2008
Period increased by $62,295 to $63,395 versus $1,100 compared to
the same
period last year.
|
·
|
Analysis
research cost increased during the Fiscal 2008 Period by $117,750
to
$117,990 from $240. This increase consists of $55,240 in warrant
expense
recorded based on the Black-Scholes calculation with the balance
in fees
and printing expense.
|
·
|
Penalty
expense increased during the Fiscal 2008 Period by $31,778 to $31,778.
This expense was recorded due to the delay of effectiveness of the
registration statement on Form SB-2, File No. 333-147752.
|
·
|
Overall
occupancy costs, investor conference expenses and related travel
expenses
in the Fiscal 2008 Period increased by $70,789 or 54% to $201,747
to
$130,958 primarily due to increased attendance at scientific and
investor
conferences compared to the Fiscal 2007
Period.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $8,673,
or
20%, to $52,180 from $43,507 primarily due to an increase in fixed
assets
and intangibles in the Fiscal 2008 Period compared to the Fiscal
2007
Period.
|
|
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
|
|
ADVAXIS,
INC.
Registrant
|
|||
Date: June
13, 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
|