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
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Balance
Sheet at July 31, 2008 (unaudited)
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3
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Statements
of Operations for the three and nine month periods ended July 31,
2008 and
2007 (unaudited), and the period March 1, 2002 (inception) to July
31,
2008 (unaudited)
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4
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Statement
of Cash Flows Statements for the nine month periods ended July 31,
2008
and 2007 and the period March 1, 2002 (inception) to July 31, 2008
(unaudited)
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5
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Notes
to Condensed Financial Statements
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7
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Item
2. Management’s Discussion and Analysis
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9
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Item
3. Controls and Procedures
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14
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14
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||
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14
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15
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CERTIFICATIONS
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July 31,
2008
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|||
Current
Assets:
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||||
Cash
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$
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260,596
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||
Prepaid
expenses
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105,206
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|||
Total Current Assets
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365,802
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|||
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||||
Property
and Equipment (net of accumulated depreciation of $82,928)
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100,309
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|||
Intangible
Assets (net of accumulated amortization of $200,927)
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1,224,882
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|||
Other
Assets
|
3,876
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|||
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||||
Total
Assets
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$
|
1,694,869
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||
LIABILITIES
& SHAREHOLDERS’ EQUITY
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||||
Current
Liabilities:
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||||
Accounts
payable
|
$
|
900,459
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||
Accrued
expenses
|
406,804
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|||
Deferred
revenue
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6,596
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|||
Interest
payable
|
18,579
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|||
Notes
payable - current portion
|
64,832
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|||
Total
Current Liabilities
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1,397,270
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|||
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||||
Notes
payable - net of current portion
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8,685
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|||
Total
Liabilities
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1,405,955
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|||
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||||
Shareholders’
Equity:
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||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued
and
outstanding
|
-
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|||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 109,319,520 shares
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109,320
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|||
Additional
Paid-In Capital
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16,540,857
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|||
Deficit
accumulated during the development stage
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(16,361,263
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)
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||
Total
Shareholders' Equity
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288,914
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|||
Total
Liabilities and Shareholders’ Equity
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$
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1,694,869
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|
3 Months
Ended
July
31,
2008
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3 Months
Ended
July
31,
2007
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9 Months
Ended
July
31,
2008
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9 Months
Ended
July
31,
2007
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Period from
March 1, 2002
(Inception) to
July
31,
2008
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|||||||||||
Revenue
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$
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28,045
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$
|
-
|
$
|
68,404
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$
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154,201
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$
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1,327,840
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||||||
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||||||||||||||||
Research
& Development Expenses
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657,286
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372,434
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2,004,324
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1,397,033
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7,380,468
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|||||||||||
General
& Administrative Expenses
|
605,319
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448,492
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2,349,439
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2,296,393
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9,322,326
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|||||||||||
Total
Operating expenses
|
1,262,605
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820,926
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4,353,763
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3,693,426
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16,702,794
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|||||||||||
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||||||||||||||||
Loss
from Operations
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(1,234,560
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)
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(820,926
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)
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(4,285,359
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)
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(3,539,225
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)
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(15,374,954
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)
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||||||
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|||||||||||||||
Other
Income (expense):
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|||||||||||||||
Interest
expense
|
(1,773
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)
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(108,952
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)
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(5,705
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)
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(474,488
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)
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(1,078,924
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)
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||||||
Other
Income
|
2,599
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3,168
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46,427
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41,140
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246,255
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|||||||||||
Gain
on note retirement
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-
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-
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-
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319,967
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1,532,477
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|||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
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-
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2,044,825
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1,598,147
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(1,642,232
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)
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|||||||||||
Net
(loss) Income
|
(1,233,734
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)
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1,118,115
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(4,244,637
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)
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(2,054,459
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)
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(16,317,379
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)
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|||||||
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||||||||||||||||
Dividends
attributable to preferred shares
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-
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-
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-
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-
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43,884
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|||||||||||
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||||||||||||||||
Net
(loss) Income applicable to Common Stock
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$
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(1,233,734
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)
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$
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1,118,115
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$
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(4,244,637
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)
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$
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(2,054,459
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)
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$
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(16,361,263
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)
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||||||||||||||||
Net
(loss) Income per share, basic
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$
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(0.01
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)
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$
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0.02
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$
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(0.04
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)
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$
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(0.05
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)
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||||
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||||||||||||||||
Net
(loss) Income per share, diluted
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$
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(0.01
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)
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$
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0.02
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$
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(0.04
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)
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$
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(0.05
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)
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|||||
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|||||||||||||||
Weighted
average number of shares outstanding, basic
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109,157,170
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45,825,888
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108,513,191
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43,568,150
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||||||||||||
Weighted
average number of shares outstanding, diluted
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109,157,170
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54,773,193
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108,513,191
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43,568,150
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9 Months
ended
July 31,
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9 Months
ended
July 31,
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Period from
March 1, 2002
(Inception) to
July 31,
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|||||||
|
2008
|
2007
|
2008
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|||||||
OPERATING
ACTIVITIES
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||||||||||
Net
loss
|
$
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(4,244,637
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)
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$
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(2,054,459
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)
|
$
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(16,317,379
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)
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Adjustments
to reconcile net loss to net cash used in operating
activities:
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||||||||||
Non-cash
charges to consultants and employees for options and
stock
|
311,806
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826,769
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1,809,672
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|||||||
Amortization
of deferred financing costs
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-
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97,122
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260,000
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|||||||
Non-cash
interest expense
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3,002
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264,886
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513,280
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|||||||
Accrued
interest on notes payable
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107,868
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|||||||||
Loss
on change in value of warrants and embedded
derivative
|
-
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(1,598,147
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)
|
1,642,232
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||||||
Value
of penalty shares issued
|
31,778
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-
|
149,276
|
|||||||
Depreciation
expense
|
26,975
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23,011
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82,928
|
|||||||
Amortization
expense of intangibles
|
51,795
|
40,077
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204,098
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|||||||
Gain
on note retirement
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-
|
(319,967
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)
|
(1,532,477
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)
|
|||||
Decrease
(Increase) in prepaid expenses
|
94,711
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(5,815
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)
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(105,206
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)
|
|||||
Decrease
(Increase) in other assets
|
-
|
725
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(3,876
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)
|
||||||
Increase
in accounts payable
|
113,162
|
428,901
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1,337,665
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|||||||
Increase
(Decrease) in accrued expenses
|
101,781
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(213,122
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)
|
390,617
|
||||||
Increase
in interest payable
|
-
|
-
|
18,291
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|||||||
Increase
(Decrease) in deferred revenue
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6,596
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(20,350
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)
|
6,596
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||||||
Net
cash used in Operating Activities
|
(3,503,031
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)
|
(2,422,503
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)
|
(11,544,283
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)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(10,842
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)
|
(32,873
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)
|
(137,657
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)
|
||||
Cost
of intangible assets
|
(178,542
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)
|
(183,781
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)
|
(1,503,932
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)
|
||||
Net
cash used in Investing Activities
|
(189,384
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)
|
(216,654
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)
|
(1,686,529
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)
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||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
-
|
960,000
|
||||||||
Cash
paid for deferred financing costs
|
-
|
(260,000
|
)
|
|||||||
Principal
payment on notes payable
|
(10,960
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)
|
-
|
(103,047
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)
|
|||||
Proceeds
from notes payable
|
-
|
(6,648
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)
|
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 (used in) provided by Financing Activities
|
(88,973
|
)
|
(6,648
|
)
|
13,491,408
|
|||||
Net
(Decrease) Increase in cash
|
(3,781,388
|
)
|
(2,645,805
|
)
|
260,596
|
|||||
Cash
at beginning of period
|
4,041,984
|
2,761,166
|
-
|
|||||||
Cash
at end of period
|
$
|
260,596
|
$
|
115,361
|
$
|
260,596
|
|
9 Months
ended
July
31,
2008
|
9 Months
ended
July
31,
2008
|
Period from
March 1, 2002
(Inception) to
July
31, 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
|
-
|
$
|
700,000
|
$
|
2,602,322
|
|||||
Intangible
assets acquired with notes payable
|
-
|
-
|
$
|
360,000
|
||||||
D
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
|
July
31, 2008
|
Increase (Decrease)
|
|||||||
Trademark
|
$
|
87,857
|
$
|
98,316
|
$
|
10,459
|
||||
License
|
496,127
|
529,915
|
33,788
|
|||||||
Patents
|
663,283
|
797,578
|
134,295
|
|||||||
Total
intangibles
|
1,247,267
|
1,425,809
|
178,542
|
|||||||
Accumulated
Amortization
|
(149,132
|
)
|
(200,927
|
)
|
51,795
|
|||||
Intangible
Assets
|
$
|
1,098,135
|
$
|
1,224,882
|
$
|
126,747
|
|
Loss
Per Share:
|
As of
July
31, 2007
|
As of
July
31, 2008
|
||||||
Warrants
|
25,009,220
|
94,149,587
|
|||||
Stock
Options
|
8,512,841
|
8,812,841
|
|||||
Convertible
Debt (1)
|
8,000,000
|
-
|
|||||
Total
All
|
41,522,061
|
102,962,428
|
|
Uncertain
Tax Provisions:
|
|
Secured
Convertible Debenture:
|
·
|
Clinical
trial expenses increased by $139,214, or 335%, to $180,781 from $41,567
due to our higher clinical trial activity to close out the trial
in the Fiscal 2008 Quarter in preparation to file our
IND.
|
·
|
Wages,
options and lab costs increased by $125,008, or 65% to $318,411 from
$193,403 principally due to our expanded research and development
efforts,
the hiring of an Executive Director of Product Development, a wage
increase on November 1, 2007 and an increase in the bonus
accrual.
|
·
|
Consulting
expenses decreased by $10,024, or 52%, to $9,357 from $19,381, primarily
reflecting reduced outside support in Fiscal 2008 as a result of
hiring an
Executive Director of Product Development.
|
·
|
Subcontracted
research expenses increased by $25,605, or 179%, to $39,900 from
$14,295,
primarily reflecting the increased subcontract work performed by
Dr.
Paterson at Penn, pursuant to the our sponsored research agreement
in the
Fiscal 2008 Quarter compared to the same period last
year.
|
·
|
Manufacturing
expenses increased by $31,691, or 41% to $108,838 from $77,147; the
result
of the ongoing clinical supply program for our upcoming Phase II
trial in
the Fiscal 2008 Quarter compared to the start-up of a manufacturing
program in the Fiscal 2007 Quarter.
|
·
|
Toxicology
study expenses decreased by $26,640, 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 $67,814, or 31% to $284,945
from
$217,131 primarily due an increase in the Chief Executive Officer’s
(“CEO”) base pay ($25,000) per his employment agreement and overall higher
wages for employees due to a wage increase on November 1, 2007 with
a
corresponding increase in benefit costs.
|
·
|
Consulting
fees and expenses increased by $176,966 to $39,682 from a credit
of
$137,284. This increase was primarily attributed to an adjustment to
fair value of Mr. Appel’s (LVEP Management, LLC (“LVEP”)) stock options in
the Fiscal 2007 Quarter amounting to a credit of $204,451 partially
offset
by increases in other consulting expenses due to lower fees recorded
in
the Fiscal 2008 Quarter verses the fees for other consultants in
the
Fiscal 2007 Quarter.
|
·
|
Legal,
accounting, professional and public relations expenses increased
by
$3,149, or 2%, to $151,827 from $148,678, due to higher patent and
tax/accounting expenses offset by fewer security filings and public
relation expense in the Fiscal 2008 Quarter versus the Fiscal 2007
Quarter.
|
·
|
Overall
occupancy, investor conference and related travel expenses in Fiscal
2008
Quarter decreased by $49,117 or 33% to $100,926 from $150,043 primarily
due to lower attendance at scientific and investor conferences partially
offset by an increase in travel and entertainment and insurance cost
compared to the Fiscal 2007 Quarter.
|
·
|
Offering
expenses decreased by $48,994 to $1,350 from $50,344 due to the
preliminary services for the October 2007 raise in Fiscal 2007 Quarter
not
repeated in Fiscal 2008 Quarter.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $7,009,
or
36%, to $26,590 from $19,581 primarily due to an increase in intangibles
in the Fiscal 2008 Quarter compared to the Fiscal 2007
Quarter.
|
·
|
Clinical
trial expenses decreased by $52,437, or 16%, to $281,525 from $333,962
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 $249,782, or 39% to $890,421 from
$640,640 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 $55,184, or 37%, to $95,880 from $151,064,
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 $7,330, or 6%, to $121,024 from $128,354,
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 $510,102 to $588,834 from $78,732 as a result
of the
ongoing clinical supply program for our upcoming Phase II trial compared
to the manufacturing program in the Fiscal 2007 Period.
|
·
|
Toxicology
study expenses decreased by $37,640, or 59% to $26,640 from $64,280
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.
|
·
|
Wages,
Options and benefit expenses increased by $308,537, or 49% to $942,166
from $633,629 primarily due to the increase of the CEO’s base pay by
$75,000 and stock compensation of $71,250 per his employment agreement
and
overall higher wages and benefits for employees due to a wage increase
on
November 1, 2007.
|
·
|
Consulting
fees and expenses decreased by $465,963, or 56%, to $371,919 from
$837,882. 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 $362,115 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 $227,303 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
$10,291, or 2%, to $439,400 from $429,109, primarily as a result
of higher
patent and tax and accounting expense partially offset by fewer security
and public relations 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.
|
·
|
Offering
expense decreased by $17,216 to $33,128 from $50,344 due primarily
to
penalty expense of $3,778 recorded during the Fiscal 2008 Period
due to
the delay of effectiveness of the registration statement on Form
SB-2,
File No. 333-147752 versus $50,344 recorded in the Fiscal 2007 Period.
|
·
|
Overall
occupancy costs, investor conference expenses and related travel
expenses
in the Fiscal 2008 Period increased by $21,671 or 8% to $302,672
from
$281,001 primarily due to increased travel and related expense at
scientific and investor conferences compared to the Fiscal 2007
Period.
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $15,682,
or
25%, to $78,770 from $63.088 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: September
22, 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
|