·
|
Up
to 37,099,457 of the shares outstanding as of February 28,
2006;
|
·
|
Up
to 43,341,513 shares underlying our Convertible Secured Debentures
due
February 1, 2009 sold in a February and March 2006 private
placement
|
·
|
Up
to 24,130,588 shares underlying warrants, including 4,500,000 shares
underlying warrants issued in the Debenture private
placement
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in early
2006*
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006*
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in early 2007
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical
|
||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
|
||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
· |
Initiate
and complete Phase I clinical study of Lovaxin C;
|
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and
|
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies.
|
Year
ended December
31,
|
Ten
Months Ended
October
31,
|
Year
Ended
October
31,
|
3
Months
Ended
January
31,
|
|||||||||||||||||||
Statement
of Operations Data:
|
2003
|
2003
|
2004
|
2004
|
2005
|
2005
|
2006
|
|||||||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||||||||||||
Revenue
|
$
|
4,000
|
$
|
3,600
|
$
|
116,406
|
$
|
116,806
|
$
|
552,868
|
$
|
---
|
$
|
329,928
|
||||||||
Total
operating expenses
|
$
|
897,076
|
$
|
821,725
|
$
|
650,310
|
$
|
715,754
|
$
|
2,395,328
|
$
|
245,126
|
$
|
798,990
|
||||||||
Interest
expense (income)
|
$
|
17,190
|
$
|
7,288
|
$
|
4,229
|
$
|
13,132
|
$
|
(36,671
|
)
|
$
|
2,968
|
$
|
1,008
|
|||||||
Other
income
|
$
|
521
|
$
|
106
|
$
|
57
|
$
|
72
|
$
|
--
|
$
|
2,739
|
$
|
11,931
|
||||||||
Provision
for income taxes
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
|||||||||||||||
Net
loss
|
$
|
(909,745
|
)
|
$
|
(825,907
|
)
|
$
|
(538,076
|
)
|
$
|
(655,892
|
)
|
$
|
(1,805,789
|
)
|
$
|
(245,355
|
)
|
$
|
(458,139
|
)
|
|
Loss
per Share Information:
|
||||||||||||||||||||||
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
Balance
Sheet Data:
|
December
31,
|
October
31,
|
October
31,
|
January
31
|
|||||||||
2003
|
2004
|
2005
|
2006
|
||||||||||
Cash
and cash equivalents
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
$
|
1,805,640
|
|||||
Intangible
assets
|
$
|
277,243
|
$
|
469,803
|
$
|
751,088
|
$
|
765,245
|
|||||
Total
assets
|
$
|
324,403
|
$
|
502,083
|
$
|
2,904,039
|
$
|
2,646,651
|
|||||
Total
liabilities
|
$
|
1,131,138
|
$
|
1,841,579
|
$
|
1,152,465
|
$
|
1,188,155
|
|||||
Stockholders’
equity (deficiency)
|
$
|
(806,735
|
)
|
$
|
(1,339,496
|
)
|
$
|
1,751,575
|
$
|
1,458,496
|
Common
stock offered by Selling Stockholders
|
73,564,540(1)
|
Common
stock outstanding as of January
31, 2006
|
38,167,028
shares (2)
|
Use
of proceeds
|
We
will not receive any proceeds from the sale of the common stock,
but we
will receive funds from the exercise of warrants by selling stockholders,
if exercised for cash.
|
“OTC
Bulletin Board Quote” as of March 2, 2006.
|
$.26
|
(1)
|
Represents
37,099,457 shares issued to Selling Stockholders, 24,130,588 shares
which
may be acquired upon exercise of warrants issued to Selling Stockholders,
and 12,334,495 shares which may be acquired upon conversion of
principal
and interest on our Debentures issued to a Selling Stockholder
in February
2006 at a fixed conversion price of $0.287 per share. Such price
is to be
revised downward if the “market price” as defined is lower at time of
conversion in which event the number of shares issued upon conversion
will
increase. Up to an additional 31,007,018 shares may be offered
for resale
by the Selling Stockholders pursuant to this Prospectus in the
event the
shares were acquired by the Selling Stockholders as a result of
conversions or dividend payments at a price less than $0.287 per
share.
|
(2)
|
The
number of shares of common stock outstanding as of January 31,
2006 listed
above excludes, in addition to the shares
offered,
|
· |
20,509,220
shares issuable upon exercise of the warrants with exercise prices
ranging
from $0.1952 to $0.40 per share;
|
· |
5,959,078 additional
shares of common stock issuable upon exercise of
options;
|
· |
Commitments
to issue stock, options or warrants.
|
· |
competition
from companies that have substantially greater assets and financial
resources than we have;
|
· |
need
for acceptance of products;
|
· |
ability
to anticipate and adapt to a competitive market and rapid technological
developments;
|
· |
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
|
· |
need
to rely on multiple levels of outside funding due to the length of
the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry;
and
|
· |
dependence
upon key personnel including key independent consultants and
advisors.
|
·
|
The
number of and the outcome of clinical studies we are planning to
conduct.
For example, our R&D expenses may increase based on the number of
late-stage clinical studies which we may be required to
conduct;
|
·
|
The
number of products entering into development from late-stage research.
For
example, there is no guarantee that internal research efforts will
succeed
in generating sufficient data for us to make a positive development
decision or that an external candidate will be available on terms
acceptable to us. Some promising candidates may not yield sufficiently
positive pre-clinical results to meet our stringent development
criteria;
|
·
|
In-licensing
activities, including the timing and amount of related development
funding
or milestone payments. For example, we may enter into agreements
requiring
us to pay a significant up-front fee for the purchase of in-process
research and development which we may record as an R&D
expense;
|
·
|
As
part of our strategy, we invest in R&D. R&D as a percent of future
potential revenues can fluctuate with the changes in future levels
of
revenue. Lower revenues can lead to more limited spending on R&D
efforts; and
|
·
|
Future
levels of revenue.
|
·
|
Pre-clinical
study results that may show the product to be less effective than
desired
(e.g., the study failed to meet its primary objectives) or to have
harmful
or problematic side effects;
|
·
|
Failure
to receive the necessary regulatory approvals or a delay in receiving
such
approvals. Among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study
endpoints,
additional time requirements for data analysis or BLA preparation,
discussions with the FDA, an FDA request for additional pre-clinical
or
clinical data, or unexpected safety or manufacturing
issues.
|
·
|
Manufacturing
costs, pricing or reimbursement issues, or other factors that make
the
product uneconomical; and
|
·
|
The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
· |
significant
time and effort from our management
team;
|
· |
coordination
of our research and development programs with the research and development
priorities of our collaborators;
and
|
· |
effective
allocation of our resources to multiple
projects.
|
· |
decreased
demand for our product candidates,
|
· |
injury
to our reputation,
|
· |
withdrawal
of clinical trial participants,
|
· |
costs
of related litigation,
|
· |
substantial
monetary awards to patients or other claimants,
|
· |
loss
of revenues,
|
· |
the
inability to commercialize product candidates,
and
|
· |
increased
difficulty in raising required additional funds in the private and
public
capital markets.
|
· |
price
and volume fluctuations in the overall stock market from time to
time;
|
· |
fluctuations
in stock market prices and trading volumes of similar companies;
|
· |
actual
or anticipated changes in our earnings or fluctuations in our operating
results or in the expectations of securities analysts;
|
· |
general
economic conditions and trends;
|
· |
major
catastrophic events;
|
· |
sales
of large blocks of our stock;
|
· |
departures
of key personnel;
|
· |
changes
in the regulatory status of our product candidates, including results
of
our clinical trials;
|
· |
events
affecting Penn or any future collaborators;
|
· |
announcements
of new products or technologies, commercial relationships or other
events
by us or our competitors;
|
· |
regulatory
developments in the United States and other countries;
|
· |
failure
of our common stock to be listed or quoted on the Nasdaq Small Cap
Market,
American Stock Exchange, OTC Bulletin Board or other national market
system;
|
· |
changes
in accounting principles; and
|
· |
discussion
of us or our stock price by the financial and scientific press and
in
online investor communities.
|
Conversion
Price
|
Number
of Shares Issuable
on Conversion of Debentures |
Percentage
of Issued
and Outstanding (1) |
$0.287
|
10,452,961
|
21.5%
|
$0.25
|
12,000,000
|
23.9%
|
$0.20
|
15,000,000
|
28.2%
|
$0.15
|
20,000,000
|
34.4%
|
$0.10
|
30,000,000
|
44.2%
|
(1) |
Assumes
38,167,028
shares outstanding immediately prior to
conversion.
|
· |
with
a price of less than $5.00 per share;
|
· |
that
are not traded on a “recognized” national exchange;
|
· |
whose
prices are not quoted on the NASDAQ automated quotation system; or
|
· |
of
issuers with net tangible assets less than $2,000,000 (if the issuer
has
been in continuous operation for at least three years) or $5,000,000
(if
in continuous operation for less than three years), or with average
revenue of less than $6,000,000 for the last three years.
|
· |
obtain
from the investor information about his or her financial situation,
investment experience and investment objectives;
|
· |
reasonably
determine, based on that information, that transactions in penny
stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions;
|
· |
provide
the investor with a written statement setting forth the basis on
which the
broker-dealer made his or her determination; and
|
· |
receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment objectives.
|
· |
The
issuance of new equity securities pursuant to a future
offering;
|
· |
Changes
in interest rates;
|
· |
Competitive
developments, including announcements by competitors of new products
or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
|
· |
Variations
in quarterly operating results;
|
· |
Change
in financial estimates by securities
analysts;
|
· |
The
depth and liquidity of the market for our common
stock;
|
· |
Investor
perceptions of our company and the technologies industries generally;
and
|
· |
General
economic and other national
conditions.
|
· |
statements
as to the anticipated timing of clinical studies and other business
developments;
|
· |
statements
as to the development of new
products;
|
· |
expectations
as to the adequacy of our cash balances to support our operations
for
specified periods of time and as to the nature and level of cash
expenditures; and
|
· |
expectations
as to the market opportunities for our products, as well as our ability
to
take advantage of those
opportunities.
|
· |
Our
limited operating history and ability to continue as a going
concern;
|
· |
Our
ability to successfully develop and commercialize products based
on our
therapies and the Listeria System;
|
· |
A
lengthy approval process and the uncertainty of FDA and other government
regulatory requirements may have a material adverse effect on our
ability
to commercialize our applications;
|
· |
Clinical
trials may fail to demonstrate the safety and effectiveness of our
applications or therapies, which could have a material adverse effect
on
our ability to obtain government regulatory
approval;
|
· |
The
degree and nature of our
competition;
|
· |
Our
ability to employ and retain qualified employees;
and
|
· |
The
other factors referenced in this prospectus, including, without
limitation, under the section entitled “Risk Factors”, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations
and Plan of Operations”, and
Business”.
|
Period
|
High
Bid
|
Low
Asked
|
7/29
- 9/30/05
|
$1.25
|
$0.15
|
10/1
- 12/31/05
|
$0.24
|
$0.20
|
1/1
- 2/28/06
|
$0.26
|
$0.18
|
January
31,
2005 |
||||
Indebtedness
|
||||
Secured
Convertible Debenture due 2/01/09
|
$
|
3,000,000
|
||
Notes
Payable*
|
443,000
|
|||
Total
indebtedness
|
$
|
3,443,000
|
||
Stockholders’
equity (deficit):
|
||||
Preferred
Stock, authorized 5,000,000
|
||||
outstanding
0 and 0
|
—
|
|||
Common
Stock, par value $.001
|
||||
authorized
500,000,000
|
||||
outstanding
38,167,028
|
38,167
|
|||
Additional
paid in capital
|
5,342,898
|
|||
Deficit
accumulated during development
|
(3,922,569
|
)
|
||
Stockholders’
Equity
|
1,458,496
|
|||
Total
capitalization
|
$
|
4,901,496
|
Year
ended
December
31,
|
Ten
Months Ended
October
31,
|
Year Ended
October
31,
|
3
Months
Ended
January
31,
|
|||||||||||||||||||
Statement
of Operations Data:
|
2003
|
2003
|
2004
|
2004
|
2005
|
2005
|
2006
|
|||||||||||||||
(unaudited)
|
(unaudited)
|
(unaudited
|
(unaudited
|
|||||||||||||||||||
Revenue
|
$
|
4,000
|
$
|
3,600
|
$
|
116,406
|
$
|
116,806
|
$
|
552,868
|
$
|
---
|
$
|
329,928
|
||||||||
Total
operating expenses
|
$
|
897,076
|
$
|
821,725
|
$
|
650,310
|
$
|
715,754
|
$
|
2,395,328
|
$
|
245,126
|
$
|
798,990
|
||||||||
Interest
expense (income)
|
$
|
17,190
|
$
|
7,288
|
$
|
4,229
|
$
|
13,132
|
$
|
(36,671
|
)
|
$
|
2,968
|
$
|
1,008
|
|||||||
Other
income
|
$
|
521
|
$
|
106
|
$
|
57
|
$
|
72
|
$
|
--
|
$
|
2,739
|
$
|
11,931
|
||||||||
Provision
for income taxes
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
|||||||||||||||
Net
loss
|
$
|
(909,745
|
)
|
$
|
(825,907
|
)
|
$
|
(538,076
|
)
|
$
|
(655,892
|
)
|
$
|
(1,805,789
|
)
|
$
|
(245,355
|
)
|
$
|
(458,139
|
)
|
|
Loss
per Share Information:
|
||||||||||||||||||||||
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
Balance
Sheet Data:
|
December
31,
|
October
31,
|
October
31,
|
January
31
|
|||||||||
2003
|
2004
|
2005
|
2006
|
||||||||||
Cash
and cash equivalents
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
$
|
1,805,640
|
|||||
Intangible
assets
|
$
|
277,243
|
$
|
469,803
|
$
|
751,088
|
$
|
765,245
|
|||||
Total
assets
|
$
|
324,403
|
$
|
502,083
|
$
|
2,904,039
|
$
|
2,646,651
|
|||||
Total
liabilities
|
$
|
1,131,138
|
$
|
1,841,579
|
$
|
1,152,465
|
$
|
1,188,155
|
|||||
Stockholders’
equity (deficiency)
|
$
|
(806,735
|
)
|
$
|
(1,339,496
|
)
|
$
|
1,751,575
|
$
|
1,458,496
|
· |
Initiate
and complete phase I clinical study of Lovaxin C;
|
· |
Continue
pre-clinical development of our
products;
|
· |
Continue
research to expand our technology
platform.
|
· |
Cost
incurred through January 31, 2006: approximately
$1,000,000
|
· |
Estimated
future costs: $700,000
|
· |
Anticipated
completion date: second quarter of fiscal
2006
|
· |
Risks
and uncertainties:
|
– |
the
FDA (or relevant foreign regulatory authority) may not approve the
study
|
– |
any
adverse event in a patient in the
trial
|
– |
difficulty
in recruiting patients
|
– |
delays
in the program
|
– |
strong
side effects in patients in the
trial
|
· |
Commencement
of material cash flows:
|
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to
a
marketing collaboration subject to regulatory approval to market
and sell
the product.
|
· |
Cost
incurred through January 31, 2006:
$300,000
|
· |
Estimated
future costs: $1,800,000
|
· |
Anticipate
completion dates: second quarter of fiscal
2007
|
· |
Risks
and uncertainties:
|
– |
Obtaining
favorable animal data
|
– |
Proving
low toxicity in animals and
obtaining favorable animal data
|
– |
Manufacturing
scale up to GMP level
|
– |
FDA
(or foreign regulatory authority) may not approve the
study
|
– |
The
occurrence of an adverse event in a
patient
|
– |
Delays
in the program
|
· |
Commencement
of material cash flows:
|
– |
Unknown
at this stage, upon a licensing deal or pursuant to a marketing
collaboration subject to regulatory approval to market and sell the
product.
|
· |
Cost
incurred through January 31, 2006:
$100,000
|
· |
Estimated
future costs: $1,500,000
|
· |
Anticipate
completion dates: third quarter of fiscal
2007
|
· |
Risks
and uncertainties:
|
– |
Obtaining
favorable animal data
|
– |
Proving
low toxicity in animals and obtaining favorable animal
data
|
– |
Manufacturing
scale up to GMP levels
|
– |
FDA
(or foreign regulatory authority) may not approve the study
initiation
|
– |
Adverse
event in a patient in the program
|
– |
Delays
in the program
|
· |
Commencement
of material cash flows:
|
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to
a
marketing collaboration subject to regulatory approval to market
and sell
the product.
|
· |
Cost
incurred through January 31, 2006:
$200,000
|
· |
Estimated
future costs: Unknown at this
stage.
|
· |
Anticipated
completion dates: Unknown at this
stage.
|
· |
Risks
and uncertainties:
|
– |
Obtaining
favorable animal data
|
– |
Proving
low toxicity in animals and obtaining favorable animal
data
|
– |
Manufacturing
scale up to GMP levels
|
– |
FDA
(or foreign regulatory authority) may not approve the
study
|
– |
The
occurrence of an adverse event in a patient in the
program
|
– |
Delays
in the program
|
· |
Commencement
of material cash flows:
|
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to
a
marketing collaboration subject to regulatory approval to market
and sell
the product.
|
·
|
Expenses
related to toxicology studies increased by $6,341 reflecting the
ongoing
toxicology studies by Pharm Olam in connection with our Lovaxin
C product
candidates.
|
·
|
Wages
and salaries for our research and development program were $113,592.
None
were incurred in the three months ended January 31, 2005 since
our R&D
management team was recruited in early
2005.
|
·
|
Outside
research fee expenses amounted to $208,191 reflecting the subcontract
work
performed by Dr. Paterson at Penn pursuant to certain grants; none
were
incurred in the prior year.
|
·
|
Clinical
trials expenses increased by $33,915 due to the initiation of studies
in
connection with our Lovaxin C product candidates, offset primarily
by a
decrease of $34,436 in development consulting
fees.
|
·
|
Expenses
for laboratory supplies, services and other fees increased by $17,927,
reflecting the cost of initiating new laboratory
facilities.
|
·
|
Employee
related expenses decreased by $10,049, or 16.4%, from $61,391 for
the
three months ended January 31, 2005 to $51,342 for the three months
ended
January 31, 2006 arising from the change of status on January 1,
2006 of
our then Chief Executive Officer to a consultant, partially offset
by the
cost of health insurance initiated in 2005;
|
·
|
Option
expense (non-cash payments) for employees and directors was $52,190
for
the three months ended January 31, 2006. None was incurred for
the three
months ended January 31, 2005;
|
·
|
All
other expenses increased by $15,992 primarily due to rent, insurance,
depreciation and amortization partially offset by lower travel
and
entertainment;
|
·
|
A
$329,575 increase in professional fees, primarily as a result of
increases
of:
|
-
|
$195,077
in legal fees due to a prior year reclassification of $51,087 of
legal
expense related to patents and trademarks assets, and a discount
of
$127,380 in legal fees plus $16,610 in additional expense in
2006.
|
-
|
$31,420
in public relations fees related to shareholder communication.
|
-
|
$96,003
in consulting fees, of which $63,023 was due to a non-cash payment
in
stock and the balance for additional required
resources.
|
Year
Ended October 31, 2005 Compared to the Year Ended October 31,
2004
|
·
|
An
increase in our related manufacturing expenses of $416,842, from
$(7,300)
to $409,542; such increase reflects the delay in the manufacturing
program
during 2004 because of delays in funding, and the manufacturing
of Lovaxin
C in 2005 for toxicology and clinical
trials;
|
·
|
Expenses
related to toxicology studies of $293,105; reflecting the initiation
of
toxicology studies by Pharm Olam in connection with our Lovaxin
C product
candidates, and the payment of deferred license fees to Penn; none
were
incurred in the prior year.
|
·
|
Wages
and salaries related to our research and development program of
$166,346,
reflecting the recruitment of our R&D management team in early 2005;
none were incurred in the prior
year.
|
·
|
Subcontracted
work of $141,366, reflecting the subcontract work performed by
Dr.
Paterson at Penn pursuant to certain grants; none were incurred
in the
prior year.
|
·
|
employee
related expenses increased by $123,157, or 56.4%, from $218,482
for the
year ended October 31, 2004 to $341,639 for the year ended October
31,
2005 arising from a bonus to Mr. Derbin, then Chief Executive Officer,
in
stock, an increase in his salary, and the cost of health insurance
initiated in 2005;
|
·
|
offering
expenses were $117,498 for the year ended October 31, 2005 arising
from
legal and banking expenses relating to the private placement closed
in
November 2004. None were incurred for the year ended October 31,
2004;
|
·
|
an
increase in professional fees from $231,686 for the year ended
October 31,
2004 to $460,691 for the year ended October 31, 2005, primarily
as a
result of an increase in legal fees, public relations fees, consulting
fees and accounting fees.
|
·
|
a
decrease in manufacturing expenses of $(8,504) to $228,452 from
$219,948
for the earlier ten month period; such decrease reflects the delay
in the
manufacturing program during 2004 because of delays in
funding;
|
·
|
a
decrease of $110,164 in our license fees to $(54,082); as a result
of the
reclassification of license fees from an R&D expense to an investment;
|
·
|
a
decrease in our outside research fees from $97,306 to $38,382;
such
decrease reflects the completion in the 2004 ten month period of
expenses
resulting from our sponsored research agreement with Penn;
and
|
·
|
development
consulting expenses increased 105.7% from $72,988 to $150,147;
this
increase reflects primarily increased success fees due to DNA Bridges
in
connection with two NIH grants awarded to the Company in
2004
|
·
|
employee
related expenses increased by $34,790, or 22.5%, to $189,302
from $154,512
for the ten months ended October 31, 2003 arising from a bonus
to Mr.
Derbin, the then Chief Executive Officer, in stock;
|
·
|
professional
fees increased by $14,368 to $218,514 from $204,145 for the ten
months
ended October 31, 2003 principally due to (a) an increase in
consulting
fees from $95,651 to $110,332, and (b) an increase in accounting
fees from
$350 to $23,070;
|
·
|
insurance
expense was increased by $8,028 to $9,929 from $1,901 for the
ten months
ended October 31, 2003; and
|
·
|
other
General and Administrative expenses increased by $66,701 to $81,545
from
$14,844 principally due to an increase in amortization expenses,
information technology and internet expenses, postage, telephone
and
travel expenses..
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in early
2006*
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006*
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in early 2007
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
|
||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
|
||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
· |
Initiate
and complete Phase I clinical study of Lovaxin C;
|
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and
|
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies.
|
· |
optimized
the Listeria strain to be used;
|
· |
identified
and contracted with a manufacturing partner for material manufactured
in
accordance with “good manufacturing practices” or “GMP” as established by
the FDA;
|
· |
identified
a principal investigator for the
trial;
|
· |
written
a protocol; and
|
· |
commenced
preparing an investigational new drug application, or IND, with an
external consulting group.
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in
2006*
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006**
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in early 2007
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
|
||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
|
||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
U.S.
Patents
|
|
U.S.
Patent No. 6,051,237, issued April 18, 2000. Patent Application No.
08/336,372, filed November 8, 1994 for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector.” Filed November 8,
1994. Expires April 18, 2017.
|
|
U.S.
Patent No. 6,565,852, issued May 20, 2003, Paterson, et al., CIP
Patent
Application No. 09/535,212, filed March 27, 2000 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector.” Filed March 27, 2000. Expires May 20, 2020.
|
|
U.S.
Patent No. 6,099,848, issued August 8, 2000. Frankel et al., Patent
Application No. 08/972,902 “Immunogenic Compositions Comprising DAL/DAT
Double-Mutant, Auxotrophic, Attentuated Strains of Listeria and Their
Methods of Use.” Filed November 18, 1997. Expires November 18,
2017.
|
|
U.S.
Patent No. 6,504,020, issued January 7, 2003 of Divisional Application
No.
09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL And DAT Genes”.
Filed March 7, 2000., Frankel et al. Expires March 7,
2020.
|
|
U.S.
Patent No. 6,635,749, issued October 21, 2003; Divisional U.S. Patent
Application No. 10/136,253 for “Isolated Nucleic Acids Comprising Listeria
DAL and DAT Genes.” Filed May 1, 2002, Frankel, et al. Filed May 1, 2022.
Expires November 18, 2017.
|
|
U.S.
Patent No. 5,830,702, issued November 3, 1998. Patent Application
No.
08/366,477, filed December 30, 1994 for “Live, Recombinant Listeria SSP
Vaccines and Productions of Cytotoxic T Cell Response” Portnoy, et al.
Filed December 30, 1997. Expires November 3, 2015.
|
|
US
Patent No. 6,767,542 issued July 27, 2004, Paterson, et al. Patent
Application No. 09/735,450 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed December 13, 2000. Expires March 29,
2020.
|
|
U.
S. Patent Applications
|
|
U.S.
Patent Application No. 10/441,851, “Methods And Compositions For
Immunotherapy of Cancer,” Filed May 20, 2003, Paterson et
al.
|
|
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, Paterson,
et al.
|
|
Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysis o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Paterson, et al.
|
|
U.S.
Patent Application No. 10/660,194, “Immunogenic Compositions Comprising
DAL/DAT Double Mutant, Auxotrophic Attenuated Strains Of Listeria
And
Their Methods Of Use,” Filed September 11, 2003, Frankel et
al.
|
International
Patents
|
|
Australian
Patent No. 730296, Patent Application No. 14108/99 for “Bacterial Vaccines
Comprising Auxotrophic, Attenuated Strains of Listeria Expressing
Heterologous Antigens.” Filed May 18, 2000. Frankel, et al. Expires
November 13, 2018.
|
|
International
Patent Applications
|
|
Canadian
Patent Application No. 2,204,666, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson et al.
|
|
Canadian
Patent Application No. 2,309,790 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al.
|
|
Canadian
Patent Application No. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
European
Patent Application No. 95939926.2, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson, et al.
|
|
European
Patent Application No. 01928324.1 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
European
Patent Application No. 98957980.0 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al.
|
|
Israel
Patent Application No. 151942 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
|
Japanese
Patent Application No. 515534/96, filed November 3, 1995 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector”, Paterson, et al.
|
|
Japanese
Patent Application No. 2001-570290 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
· |
who
must be recruited as qualified
participants;
|
· |
how
often to administer the drug;
|
· |
what
tests to perform on the participants;
and
|
· |
what
dosage of the drug to give to the
participants.
|
Name
|
Age
|
Position
|
||
J.
Todd Derbin (1) (4)
|
53
|
Chairman
of the Board of Directors
|
||
Roni
A. Appel(1) (4)
|
39
|
President,
Chief Executive Officer, Chief Financial Officer, Secretary and
Director
|
||
Dr.
James Patton(2)
|
48
|
Director
|
||
Dr.
Thomas McKearn(3)
|
56
|
Director
|
Richard
Berman (2) (3)
|
63
|
Director
|
||
Martin Wade |
56
|
Director |
(1) |
Member
of the Finance Committee
|
(2) |
Member
of the Audit Committee.
|
(3) |
Member
of the Compensation Committee.
|
(4) |
Member
of the Nominating and Corporate Governance Committee.
|
· |
reviewing
the
results of the audit engagement with the independent registered public
accounting firm;
|
· |
identifying
irregularities
in the management of our
business in consultation with our independent accountants, and suggesting
an appropriate course of action;
|
· |
reviewing
the
adequacy, scope, and results of the internal accounting controls
and
procedures;
|
· |
reviewing
the
degree of independence of the auditors, as well as the nature and
scope of
our relationship with our independent registered public accounting
firm;
|
· |
reviewing
the
auditors’ fees; and
|
· |
recommending
the
engagement of auditors to the full Board of
Directors.
|
· |
identifying
and recommending to the Board of Directors individuals qualified
to serve
as directors of the Company and on the committees of the board;
|
· |
advising
the board with respect to matters of board composition, procedures
and
committees;
|
· |
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally;
and
|
· |
overseeing
the annual evaluation of the board and our management.
|
· |
Honest
and ethical conduct, including the ethical handling of actual or
apparent
conflicts of interest between personal and professional
relationships;
|
· |
Full,
fair, accurate, timely and understandable disclosure in reports and
documents that a we file with, or submit to, the SEC and in other
public
communications made by us;
|
· |
Compliance
with applicable governmental laws, rules and
regulations;
|
· |
The
prompt internal reporting of violations of the code to an appropriate
person or persons identified in our code of ethics;
and
|
· |
Accountability
for adherence to our code of ethics.
|
Annual
Compensation
|
Long
Term
Compensation Awards |
||||||||||||||
Name
And Principal Position
|
|
|
Year
(1)
|
Salary($)
|
Bonus($)
|
Other*
|
Securities
Underlying
Options |
||||||||
J.
Todd Derbin
|
2005
|
$
|
225,000
|
$
|
45,000
|
(4)
|
684,473
|
(5)
|
|||||||
President,
Chief Executive Officer
|
2004
|
$
|
125,000
|
$
|
60,000
|
(4)
|
—
|
||||||||
2003
|
$
|
150,000
|
1,172,727
|
(5)
|
|||||||||||
Roni
Appel
|
2005
|
$
|
139,250
|
(2)
|
$
|
35,000
|
1,114,344
|
(2)
|
|||||||
Secretary, Chief Financial |
2004
|
$
|
50,000
|
(3)
|
35,218
|
||||||||||
Officer, and Director |
2003
|
$
|
60,000
|
(3)
|
42,262
|
||||||||||
Dr.
John Rothman
|
2005
|
$
|
141,667
|
(6)
|
360,000
|
||||||||||
Vice President – |
2004
|
—
|
|||||||||||||
Clinical Development (6) |
Individual
Grants
|
|||||||||||||||||||||||
|
|
Number
Of Securities Underlying Options
|
Percent
Of Total Options Granted To Employees In
Fiscal
|
Exercise
|
Expiration
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation
For
Option
Term($)
|
|||||||||||||||||
Name
|
|
|
Year
|
|
|
Granted
|
|
|
Year)
|
|
|
|
Price
|
|
|
Date
|
|
|
5%
|
|
10%
|
||
J.
Todd Derbin(1)
|
2005
|
427,796
|
13
|
%
|
$
|
0.29
|
2/1/2015
|
$
|
78,034
|
$
|
197,753
|
||||||||||||
President,
Chief Executive Officer, and Director
|
2004
|
—
|
|
—
|
—
|
—
|
—
|
||||||||||||||||
2003
|
928,441
|
86
|
%
|
0.195
|
11/1/2012
|
$
|
113,878
|
$
|
288,587
|
||||||||||||||
Roni
Appel
|
2005
|
1,114,344
|
(2)
|
34
|
%
|
$
|
0.29
|
3/31/2015
|
$
|
201,165
|
$
|
509,788
|
|||||||||||
Secretary, Chief Executive Officer, and Director |
2004
|
35,218
|
27
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
7,753
|
$
|
19,648
|
||||||||||||
2003
|
42,262
|
4
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
9,304
|
$
|
23,578
|
|||||||||||||
Dr.
John Rothman
|
2005
|
360,000
|
11
|
%
|
$
|
0.29
|
3/1/2015
|
$
|
64,988
|
$
|
164,692
|
(1) |
Under
the 2005 option plan, 684,473 options were granted to Mr. Derbin,
of which
256,677 options were surrendered pursuant to a termination
of employment
agreement. Under the 2004 plan (which replaced the 2003 plan)
1,172,767
options were granted to Mr. Derbin of which 244,326 options
were
surrendered pursuant to a termination of employment
agreement.
|
(2) |
Reflects
the grant to Mr. Appel equal to 3% of the outstanding shares
of the
company made in April 2005. Does not reflect a subsequent grant
increasing
the number of options to 5% of the shares and options of the
Company which
was made in the current fiscal
year.
|
Number
Of Securities
Underlying
Unexercised
Options
At Fiscal Year-End(1)
|
Value
Of Unexercised
In-The-Money
Options
At
Fiscal Year-End($)(2)
|
||||||||||||||||||||
Shares
Acquired
|
|||||||||||||||||||||
Name
|
Year
|
On
Exercise
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|||||||||||||||
J.
Todd Derbin
|
2005
|
0
|
1,273,135
|
83.101
|
$
|
47,033
|
$
|
4,017
|
|||||||||||||
|
2004
|
0
|
586,382
|
586,382
|
$
|
53,947
|
$
|
51,015
|
|||||||||||||
|
2003
|
0
|
293,191
|
879,575
|
$
|
26,974
|
$
|
80,921
|
|||||||||||||
Dr.
James Patton
|
2005
|
0
|
73,253
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||
|
2004
|
0
|
33,808
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||
|
2003
|
0
|
33,810
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||
Roni
Appel
|
2005
|
0
|
254,075
|
951,835
|
$
|
—
|
$
|
—
|
|||||||||||||
|
2004
|
0
|
91,567
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||
|
2003
|
0
|
49,305
|
—
|
$
|
—
|
$
|
—
|
|||||||||||||
Dr.
Vafa Shahabi
|
2005
|
0
|
0
|
150,000
|
$
|
—
|
$
|
—
|
|||||||||||||
Dr.
John Rothman
|
2005
|
0
|
0
|
360,000
|
$
|
—
|
$
|
—
|
(1) |
Certain
of the options are immediately exercisable for all the option
shares as of
the date of grant but any shares purchased are subject to repurchase
by us
at the original exercise price paid per share if the optionee
ceases
service with us before vesting in such shares.
|
(2) |
The
price at end of fiscal year 2005 is based on a price per share
of $0.25,
the highest-bid price on October 31, 2005 quoted on the OTCBB.
The price
for previous years is based on the fair market value of our common
stock
at fiscal year end of $0.195 per share prior to November 11,
2004, and
$0.287 per share post November 11, 2004, determined by the board
to be
equal to our Private Placement price per share less the exercise
price
payable for such shares.
|
· |
each
person
who is known by us to be the owner of record or beneficial owner
of more
than 5% of our
outstanding common stock;
|
· |
each
of
our directors and each of our executive officers;
|
· |
all
of
our directors and executive officers as
a group; and
|
· |
the
number
of
shares
of common stock beneficially
owned
by each such person and such group and the percentage of the outstanding
shares owned by each such person and such
group.
|
Name
and Address of Beneficial Owner
|
Number
of Shares
of Registrant Common Stock Beneficially Owned as of March 31, 2006 |
Percentage
of Class Beneficially
Owned
|
|||||
J.
Todd Derbin(1)(2)
|
2,195,034
|
(3)
|
5.47
|
%
|
|||
Roni
Appel(1)(2)
|
5,372,160
|
(4)
|
13.16
|
%
|
|||
Richard
Berman(1)
|
440,000
|
(6)
|
1.13
|
%
|
|||
Dr.
James Patton(1)
|
2,930,379
|
(7)
|
7.60
|
%
|
|||
Dr.
Thomas McKearn(1)
|
524,876
|
(8)
|
1.35
|
%
|
|||
Martin
Wade(1)
|
150,000
|
0.39
|
%
|
||||
Dr.
John Rothman(2)
|
590,000
|
1.52
|
%
|
||||
Dr. Vafa Shahabi(2) | 230,000 | 0.60 |
%
|
||||
Frederick Cobb(2) | 150,000 | 0.39 | % | ||||
Scott
Flamm(1)
|
2,914,989
|
(5)
|
7.53
|
%
|
|||
The
Trustees of the University of Pennsylvania
Center
for Technology
Transfer,
University of Pennsylvania
3160
Chestnut Street, Suite 200
Philadelphia,
PA 19104-6283
|
6,339,282
|
16.50
|
%
|
||||
Sunrise
Equity Partners, LP
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
|
(9)
|
4.78
|
%
|
|||
Level
Counter, LLC
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
|
(10)
|
4.78
|
%
|
|||
Marilyn
Adler
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
|
(11)
|
4.78
|
%
|
|||
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
3,343,019
|
(12)
|
8.70
|
%
|
|||
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
2,929,511
|
(13)
|
7.62
|
%
|
|||
Emigrant
Capital Corp.
6
East 43 Street, 8th Fl.
New
York, NY 10017
|
1,838,783
|
(14)
|
4.79
|
%
|
|||
Harvest
Advaxis LLC
30052
Aventura, Suite C
Rancho
Santa Margarita, CA 92688
|
—
|
(15)
|
—
|
||||
Cornell
Capital Partners LP
101
Hudson Street, Suite 3700
Jersey
City, New Jersey 07302
|
|
(16)
|
|
(16)
|
|||
All
Directors and Officers as a Group (9 people)
|
12,582,450
|
28.36
|
%
|
(1) |
Director,
Mr. Flamm had been a Director until his death in January
2006
|
(2) |
Officer
|
(3) |
Reflects
469,982 shares, 1,356,236 options and 368,815 warrants to purchase
shares.
|
(4) |
Represents
2,620,760 shares, 14,449 warrants and 2,231,943 options owned
by Mr. Appel
and 355,528 shares and 149,480 options and warrants beneficially
owned by
Carmel Ventures, Inc. of which Mr. Appel is a controlling person;
but does
not include 58,580 warrants and 55,580 options owned by Mr. Appel
and
355,528 warrants held by Carmel Ventures, Inc., because such
warrants and
options are not under the current circumstances, exercisable
within the 60
Day Period.
|
(5) |
Reflects
125,772 shares and 91,567 options and 31,184 warrants owned by
the estate
and 2,621,325 shares and 45,141 warrants beneficially owned by
Flamm
Family Partners LP, of which the estate is a partner, but does
not reflect
125,772 warrants because such warrants are not under the current
circumstances, exercisable within the 60 Day
Period.
|
(6) |
Reflects
40,000 shares and options to purchase
400,000shares.
|
(7) |
Reflects
2,820,576 shares, 73,253 options and 36,551 warrants but does
not reflect
147,716 warrants because such warrants are not under the current
circumstances, exercisable within the 60 Day
Period.
|
(8) |
Reflects
179,290 shares and 345,586 options and
warrants.
|
(9) |
Reflects
1,742,160 shares and 93,331 warrants held by Sunrise Equity Partners,
LP
("SEP"), but does not include 1,648,829 warrants held by SEP
because such
warrants are not exercisable within the 60 Day Period. The General
Partner of SEP is Level Counter, LLC (“LC”), the managers of which are
Nathan Low, Marilyn Adler and Amnon Mandelbaum (the
"Managers"). Decisions regarding voting and disposition require
the unanimous vote of all three managers. It also does not
include: (a) 34,843 shares issuable as a penalty; (b) 1,124,253
shares and 761,971 warrants directly owned by Nathan Low; (c)
1,094,020
shares and 672,538 warrants directly owned by Mr. Mandelbaum,
and (d)
shares held by limited partners of SEP or LC who may have a direct or
indirect pecuniary interest, but have no authority to vote or
dispose of
the shares of common stock held by SEP.
|
(10) |
Reflects
1,742,160 shares and 93,331 warrants held by SEP, but does not
include
34,843 shares issuable to SEP as a penalty and 1,648,829 warrants
held by
SEP because such warrants are not, under current circumstances,
exercisable within the 60 Day Period. LC is the general partner
of SEP and
as such, is deemed to have beneficial ownership of the securities
held by
SEP. However, LC disclaims beneficial interest in the shares
and warrants
except to the extent of its pecuniary interest therein.
|
(11) |
Reflects
1,742,160 shares held by SEP and 93,331 warrants held by LC but
does not
include 1,648,829 warrants held by SEP because such warrants
are not
exercisable under current circumstances within the 60 Day Period.
Does not
reflect the 34,843 shares issuable to SEP as a penalty. Ms.
Adler is a manager of LC, the general partner of SEP, and as
such, is
deemed to have beneficial ownership of the securities held by
SEP.
However, Ms. Adler disclaims beneficial interest in such shares
except to
the extent of her pecuniary interest
therein.
|
(12) |
Reflects
1,124,253 shares owned by Mr. Low, 1,742,160 shares and 93,331
warrants
held by SEP, but does not include 761,971 warrants held by
Mr. Low and
1,648,829 warrants held by SEP because such warrants are not,
under
current circumstances, exercisable within the 60 Day Period.
Also does not
reflect the 37,725 shares issuable to Mr. Low as a penalty
and 34,843
shares issuable to SEP as a penalty. Mr.
Low is a manager of LC, the general partner of SEP, and as
such, is deemed
to have beneficial ownership of the securities held by SEP.
However, Mr.
Low disclaims beneficial interest in such shares except to
the extent of
his pecuniary interest therein. Also includes 383,275 shares
held by
Sunrise Securities Corp., of which Mr. Low is sole stockholder
and
director, but does not include 672,539 warrants owned by Mr.
Mandelbaum
and 348,432 warrants held by Sunrise Securities Corp., because
such
warrants are not, under current circumstances, exercisable
within the 60
Day Period nor does it reflect 14,634 shares issuable to Sunrise
Securities Corp. as a penalty. Mr. Low’s beneficial ownership does not
also include shares held by Sunrise Foundation Trust, a charitable
trust
of which Mr. Low is a trustee. Mr. Low disclaims beneficial
ownership of
shares held by Sunrise Foundation
Trust.
|
(13) |
Reflects
1,094,020 shares owned by Mr. Mandelbaum and 1,742,160 shares
and 93,331
warrants held by SEP, but does not include 1,648,829 warrants
held by SEP
because such warrants are not, under the current circumstances,
exercisable within the 60 Day Period and the 34,843 shares
issuable to SEP
as a penalty. Mr.
Mandelbaum is a manager of LC, the general partner of SEP,
and as such, is
deemed to have beneficial ownership of the securities held
by SEP.
However, Mr. Mandelbaum disclaims beneficial interest in such
shares
except to the extent of his pecuniary interest therein.
|
(14) |
Reflects
1,742,160 shares and 96,623 warrants, but does not include
1,645,537
warrants because such warrants are not, under current circumstances,
exercisable within the 60 Day Period nor does it reflect 34,843
shares
issuable to Emigrant as a penalty. Mr. Howard Milstein is the
Chairman and
CEO and Mr. John Hart is the President of
Emigrant.
|
(15)
|
Does
not reflect 3,832,753 warrants because such warrants are not
currently
exercisable within the 60 Day Period. Mr. Robert Harvey is
the manager of
Harvest Advaxis LLC.
|
(16)
|
Cornell
Capital Partners LP (“Cornell”) acquired in February 2006, $3,000,000
principal amount of the Debentures along with 4,500,000 warrants.
Cornell
does not beneficially own any shares except through its ownership
of the
Debentures and warrants. The Debentures are convertible into
10,452,960
shares (assuming conversion at the Fixed Conversion Price of
$0.287 per
share or a larger number if converted at the “Market Conversion Price”).
Cornell has agreed that it will not exercise its conversion
and warrant
exercise rights to the extent it would result in Cornell and
its
affiliates owning in the aggregate more than 4.9% of the outstanding
voting shares.
|
·
|
37,099,457
shares of our common stock that were issued to Selling Stockholders
pursuant to transactions exempt from registration under the
Securities Act
of 1933 (the “Act”);
|
·
|
12,334,495
shares of common stock underlying our Secured Convertible Debenture
issued
to a Selling Stockholder pursuant to a transaction exempt from
registration under the Act. Up to 31,007,018 additional shares
may be
offered by the Selling Stockholder if the Debentures are converted
in
whole or in part at a price lower than the Fixed Conversion
Price of
$0.287 per share (see “February 2006 Private Placement”);
and
|
·
|
24,130,588
shares of common stock underlying warrants that were issued
to Selling
Stockholders pursuant to transactions exempt from registration
under the
Act, including 4,500,000 warrants issued in the private placement
of our
Debentures.
|
·
|
J.
Todd Derbin has served as our Chief Executive Officer until
December 31,
2005 and a director since November 12, 2004; our Chairman of
the Board of
Directors as of January 1, 2006. He will serve as a
consultant.
|
·
|
Roni
Appel has served as President and Chief Executive Officer since
January 1,
2006 and as our Chief Financial Officer and a director since
November 12,
2004; Carmel Ventures, Inc., of which Mr. Appel is the principal
stockholder has provided consulting services to us; LVEP by
which Mr.
Appel is employed, is providing consulting services to us and
pays his
compensation as our officer;
|
·
|
Scott
Flamm, who died in January 2006, had served as a director of
the Company
since November 12, 2004 and of LVEP, of which he was a principal
stockholder and an employee, and which provides consulting
services to us
and was a general partner of Flamm Family Partners,
L.P.
|
·
|
Thomas
McKearn has served as a director since November 12,
2004;
|
·
|
Dr.
James Patton has served as a director since November 12, 2004
and has
served as a consultant to us in the
past;
|
·
|
Dr.
Yvonne Patton has served as a
consultant;
|
·
|
The
Trustees of the University of Pennsylvania own the patents
which we have
an exclusive license;
|
·
|
Sunrise
Securities Corp. acted as placement agent in the November 2004
Private
Placement. Nathan Low, Amnon Mandelbaum, Marcia Kucher, Derek
Caldwell,
Richard Stone and David Goodfriend are all affiliated with
or employed by
Sunrise Securities Corp., the placement agent in the Private
Placement. Sunrise
Equity Partners, LP and Sunrise Foundation Trust are also affiliates
of
Sunrise Securities Corp.;
|
·
|
Dr.
David Filer is a consultant for us and provided consulting
services to the
Sunrise Securities Corp; and
|
·
|
Reitler
Brown Holdings, LLC is an affiliate of Reitler Brown & Rosenblatt LLC,
counsel to the Company.
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Adele
Pfenninger
12
Spring Brook Road
Annandale,
NJ 08801
|
79,600
(1)
|
70,790
(1)
|
0.21%
|
0.02%
|
AI
International Corporate (a) Holdings, Ltd.
c/o
FCIM Corp.
1
Rockefeller Plaza, Suite 1730
New
York, NY 10020
|
175,958
(2)
|
174,216
(2)
|
0.
46%
|
**
|
Alan
Gelband Company (b)
Defined
Contribution Pension Plan and Trust
30
Lincoln Plaza
New
York, NY 10023
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Alan
Kestenbaum
18
Clover Drive
Great
Neck, NY 11021
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Beretz
Family Partners LP (c)
48
South Drive
Great
Neck, NY 11021
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
**
|
Bridges
& Pipes, LLC (d)
830
Third Avenue
14th
Floor
New
York, NY 10022
|
1,407,665
(4)
|
1,393,728
(4)
|
3.62%
|
**
|
Bruce
Fogel
218
Everglade Avenue
Palm
Beach, FL 33480
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
C.
Leonard Gordon
551
Fifth Avenue
New
York, NY 10176
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
**
|
Carmel
Ventures, Inc* (e)
22
Ruth Lane
Demarest,
NJ 07627
|
860,537
(5)
|
711,057
(5)(a)
|
2.23%
|
0.41%
|
Catherine
Janus
4817
Creak Dr.
Western
Spring, IL 60558
|
118,832
(6)
|
105,767
(6)
|
0.31%
|
0.04%
|
Chaim
Cymerman
c/o
Tomer Cymerman
Paamoni
10, Apt. 19
Bavli,
Tel Aviv
Israel
|
196,371
(7)
|
174,593
(7)(a)
|
0.51%
|
0.06%
|
Charles
Kwon
834
Monror Street
Evanston,
Il 60202
|
494,717
(8)
|
482,322
(8)(a)
|
1.29%
|
0.02%
|
Cranshire
Capital, LP (f)
666
Dundee Road
Sute
1901
Northbrook,
IL 60602
|
1,055,749
(9)
|
1,045,296
(9)
|
2.73%
|
**
|
Crestwood
Holdings, LLC (g)
c/o
Ran Nizan
109
Boulevard Drive
Danbury,
CT 06810
|
360,253
(10)
|
337,978
(10)(a)
|
0.94%
|
0.06%
|
David
Stone
228
St. Charles Avenue,
Suite
1024
New
Orleans, LA 70130
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
David
Tendler
401
East 60th
Street
New
York, NY 10022
|
703,833
(11)
|
696,864
(11)
|
1.83%
|
**
|
Design
Investments, LTD (h)
9
Tanbark Circuit, Suite 1442
Werrington
Downs
NSW
2747
Australia
|
703,833
(11)
|
696,864
(11)
|
1.83%
|
**
|
Emigrant
Capital Corp. (i)
6
East 43rd
Street, 8th
Floor
New
York, NY 10017
|
3,519,163(12)
|
3,484,320
(12)
|
8.82%
|
**
|
Eugene
Mancino
Blau
Mancino
12
Roszel Road, Suite C-101
Princeton,
NJ 08540
|
355,099
(13)
|
212,544
(13)(a)
|
0.92%
|
0.39%
|
Fawdon
Investments Ltd. (j)
4
Ibn Shaprut Street
Jerusalem,
Israel 92478
|
1,407,665
(4)
|
1,393,728
(4)
|
3.62%
|
**
|
Flamm
Family Partners, LP.* (k)
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078
|
2,666,466
(14)
|
2,657,556
(14)(a)
|
6.98%
|
0.02%
|
Fred
Berdon Co, LP (l)
717
Post Road
Suite
105
Sacrsdale,
NY 10583
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Gina
Ferarri
36
Stone Run Road
Bedmingter,
NJ 07921
|
79,932
(15)
|
71,022
(15)(a)
|
0.21%
|
0.2%
|
Hal
H. Beretz
48
South Drive
Great
Neck, NY 11021
|
527,874
(16)
|
522,648
(16)
|
1.37%
|
**
|
Howard
Kaye Family Fund (m)
2
Mohican Trail
Scarsdale,
NY 10583
|
527,824
(16)
|
522,648
(16)
|
1.37%
|
**
|
IRA
FBO / Walter S. Grossman (n) Pershing LLC Custodian
277
North Ave.
Westport,
CT 06880
|
703,833
(11)
|
696,864
(11)
|
1.83%
|
**
|
Itai
Portnoi
26
Yakinton St.
Haifa,
Isreal 34406
|
157,608
(17)
|
140,186
(17)(a)
|
0.41%
|
0.05%
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
J.
Todd Derbin*
840
Pretty Brook Road
Princeton,
NJ 08540
|
1,837,348 (18)
|
591,532
(18)(a)
|
4.63%
|
3.24%
|
James
Patton*
1937
Swedesford
Malvern,
PA 19355
|
3,061,192
(19)
|
2,968,291(19)(a)
|
8.00%
|
0.25%
|
James
Paul
c/o
Fulwider Patton
Howard
Hughes Center
6060
Center Drive, 10th
Floor
Los
Angeles, CA 90045
|
39,215
(20)
|
34,861
(20)(a)
|
0.10%
|
0.01%
|
Jonas
Grossman
59
Huratio St.
New
York, NY 10014
|
80,640
(21)
|
71,731
(21)(a)
|
0.21%
|
0.02%
|
Kerry
Propper
59
Huratio St.
New
York, NY 10014
|
201,600
(22)
|
179,326
(22)(a)
|
0.53%
|
0.06%
|
Lilian
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078
|
197,328
(23)
|
197,328
(23)
|
0.52%
|
0.0%
|
Marilyn
Mendell
1203
River Road,
Apt.
Penthouse 4
Edgewater,
NJ 07020
|
284,500
(24)
|
253,316
(24)(a)
|
0.74%
|
0.08%
|
Mary
Ann Ryan Francis
1115
Beanaqt Ave.
Seaside
Park, NJ 08752
|
79,071
(25)
|
70,360
(25)(a)
|
0.21%
|
0.02%
|
MEA
Group, LLC (o)
145
Talmadge Road
Edison,
NJ 08817
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Mordechai
Mashiach
8
Shlomzion Hamalka
Haifa,
Isreal 34406
|
157,608
(17)
|
140,186
(17)(a)
|
0.41%
|
0.05%
|
New
Bank Ltd (p)
Levinstein
Tower #21st
23
Menahem Begin Road
Tel
Aviv, Israel
|
1,407,665
(4)
|
1,393,728
(4)
|
3.62%
|
**
|
Open
Ventures LLC (q)
127
West Chestnut Hill Ave.
Philadelphia,
PA 19118
|
17,422
|
17,422
|
0.05%
|
0.0%
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Peggy
Fern
1548
Herlong Court
Rock
Hill, SC 29732
|
79,712
(26)
|
70,081
(26)(a)
|
0.21%
|
0.02%
|
Penn
Footware Retirement Trust (r)
Line
& Grove Streets
PO
Box 87
Nanticoke,
PA 18634
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Richard
Yelovich
603
Milleson Lane
West
Chester, PA 19380
|
151,289
|
151,289
|
0.40%
|
0.0%
|
Roni
Appel*
22
Ruth Lane
Demarest,
NJ 07627
|
2,595,193 (27)
|
2,580,745
(27)(a)
|
6.80%
|
0.04%
|
RP
Capital, LLC (s)
10900
Wilshire Blvd., Suite 500
Los
Angeles, CA 90024
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
**
|
Scott
Flamm*
70
West Road
Short
Hills, NJ 07078
|
374,296
(28)
|
251,545
(28)(a)
|
0.97%
|
0.33%
|
Shai
Stern
43
Maple Aenue
Cedarhurst,
NY 11516
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
**
|
SRG
Capital, LLC (t)
120
Broadway, 40th
Floor
New
York, NY 10271
|
703,833
(11)
|
696,864
(11)
|
1.83%
|
**
|
Sunrise
Equity Partners, LP (u)
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
3,519,163(12)
|
3,484,320
(12)
|
8.82%
|
**
|
Thomas
McKearn*
6040
Lower Mountain Road
New
Hope, PA 18938
|
374,876
(29)
|
269,839
(29)(a)
|
0.93%
|
0.29%
|
Titan
Capital Management, LLC (v)
(TCMP3
Partners)
7
Centure Drive, Suite 201
Parsippany,
NJ 07054
|
703,833
(11)
|
696,864
(11)
|
1.83%
|
**
|
Tracy
Yun
90
LaSalle St., Apt. #13G
New
York, NY 10027
|
60,197
|
60,197
|
0.16%
|
0.0%
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Trinita,
LLC (w)
c/o
Morten Kielland
22
Painters Lane
Chesterbrook,
PA 19087
|
151,289
|
151,289
|
0.40%
|
0.0%
|
The
Trustees of the
University
of Pennsylvania *
Center
for Technology Transfer
University
of Pennsylvania
3160
Chestnut Street, Suite 200
Philadelphia,
PA 19104-6283
Attn:
Managing Director
|
6,339,282
|
6,339,282
|
16.61%
|
0.0%
|
William
Kahn
7903
Longmeadow Road
Baltimore,
MD 21208
|
151,517
|
151,517
|
0.40%
|
0.0%
|
Yair
Talmor
517
Old Chappaqua Road
Briarcliff
Manor, NY 10510
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
0.0%
|
Yoav
Millet
950
Third Avenue
New
York, NY 10022
|
175,958
(2)
|
174,216
(2)
|
0.46%
|
0.0%
|
Yvonne
Paterson
514
South 46 St.
Philadelphia,
PA 19143
|
873,412(30)
|
704,365
|
2.28%
|
0.46%
|
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
1,801,891
(31)
|
1,766,559
(31)
|
4.64%
|
**
|
David
Goodriend
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
198,077
(32)
|
194,193
(32)
|
0.52%
|
**
|
David
Filer*
165
East 32 Street
New
York, NY 10016
|
388,476
(33)
|
382,772
(33)
|
1.01%
|
**
|
Marcia
Kucher
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
4,223
(34)
|
4,140
(34)
|
0.01%
|
**
|
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
1,923,949
(35)
|
1,886,224
(35)
|
4.94%
|
**
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Derek
Caldwell
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
156,732
(36)
|
153,658
(36)
|
0.41%
|
**
|
Sunrise
Securities Corp.* (x)
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
746,341(37)
|
731,707
(37)
|
1.94%
|
**
|
Richard
Stone
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
313,463(38)
|
307,317(38)
|
0.82%
|
**
|
Sunrise
Foundation Trust (y)
c/o
Sunrise Securities Corp.
641
Lexington Avenue, 25th
Floor
New
York, NY 10022
|
72,927(38)(a)
|
71,497
|
0.20%
|
**
|
Martin
Trust Agreement
U/A/
DTD 11/05/01
Peter
L. Martin TTE
3757
Wedbster St, Apt 203
San
Francisco, CA 94123
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
A.
Heifetz Technologies Ltd. (z)
22
Kanfey Nesharim St
Jerusalem,
Israel 95464
|
351,916
(3)
|
348,432
(3)
|
0.92%
|
**
|
Balestra
Spectrum Partners, LLC (aa)
1185
Avenue of the Americas
32nd
Floor
New
York, NY 10036
|
1,055,749
(9)
|
1,045,296
(9)
|
2.73%
|
**
|
Reitler
Brown Holdings, LLC* (bb)
800
Third Avenue, 21st
Floor
New
York, NY 10022
|
60,000
(39)
|
60,000
(39)
|
0.20%
|
0.0%
|
Harvest
Advaxis LLC (cc)
30052
Aventura, Suite C
Rancho
Santa Margarita, CA 92688
|
7,742,161
|
7,665,506
|
20.28%
|
**
|
Miles
Wynn
P.O.
Box 440842
Aurora
, CO 80044
|
696,700
|
696,700
|
1.83%
|
0.0%
|
Teresa
Waz
3679
S. Dawson St.
Aurora,
CO 80444
|
26,900
|
26,900
|
0.07%
|
0.0%
|
Name
|
Total
Shares
Owned
Before
Offering
|
Shares
Registered
|
%
Before
Offering
|
%
After
Offering
|
Ormonde
Frew
19996
E. Greenwood Drive
Aurora
, CO 80013
|
12,000
|
12,000
|
0.03%
|
0.0%
|
Ralph
Grills
4042
S. Atchison Way
Aurora,
CO 80014
|
12,000
|
12,000
|
0.03%
|
0.0%
|
Daniel
Unrein
281
S. Leyden St.
Denver,
CO 80220
|
2,500
|
2,500
|
**
|
0.0%
|
Frederick
Malkhe
4105
E. Florida Ave., Suite 100
Denver,
CO 80222
|
2,500
|
2,500
|
**
|
0.0%
|
(1)
|
Reflects
35,395 shares of common stock 44,205 warrants to purchase
shares of common
stock.
|
(2)
|
Reflects
87,108 shares of common stock and 87,108 warrants to purchase
shares of
common stock.
|
(3)
|
Reflects
174,216 shares of common stock and 174,216 warrants to purchase
shares of
common stock.
|
(4)
|
Reflects
696,864 shares of common stock and 696,864 warrants to purchase
shares of
common stock.
|
(5)
|
Reflects
355,528 shares of common stock, 413,441 warrants to purchase
shares of
common stock and 91,567 options exercisable for shares of
common
stock.
|
(5)(a)
|
Reflects
355,528 shares of common stock and 355,528 warrants to purchase
shares of
common stock
|
(6)
|
Reflects
52,833 shares of common stock and 52.883 warrants to purchase
shares of
common stock.
|
(7)
|
Reflects
87,297 shares of common stock and 109,074 warrants to purchase
shares of
common stock.
|
(7)(a)
|
Reflects
87,297 shares of common stock and 87,297 warrants to purchase
shares of
common stock.
|
(8)
|
Reflects
271,260 shares of common stock and 219,973 warrants to purchase
shares of
common stock.
|
(8)(a)
|
Reflects
271,260 shares of common stock and 211,063 warrants to purchase
shares of
common stock.
|
(9)
|
Reflects
522,648 shares of common stock and 522,648 warrants to purchase
shares of
common stock.
|
(10)
|
Reflects
244,933 shares of common stock and 115,320 warrants to purchase
shares of
common stock.
|
(10)(a)
|
Reflects
244,933.shares of common stock and 93,046 warrants to purchase
shares of
common stock.
|
(11)
|
Reflects
348,432 shares of common stock and 348,432 warrants to purchase
shares of
common stock.
|
(12)
|
Reflects
1,742,160 shares of common stock and 1,742,160 warrants to
purchase shares
of common stock.
|
(13)
|
Reflects
106,272 shares of common stock and 248,827 warrants to purchase
shares of
common stock.
|
(13)(a)
|
Reflects
106,272 shares of common stock and 106,272 warrants to purchase
shares of
common stock.
|
(14)
|
Reflects
2,621,325 shares of common stock and 45,141 warrants to purchase
shares of
common stock.
|
(14)(a)
|
Reflects
2,621,325 shares of common stock and 36,231 warrants to purchase
shares of
common stock.
|
(15)
|
Reflects
35,511 shares of common stock and 44,421 warrants to purchase
shares of
common stock.
|
(15)(a)
|
Reflects
35,511 shares of common stock and 35,511 warrants to purchase
shares of
common stock.
|
(16)
|
Reflects
261,324 shares of common stock and 261,324 warrants to purchase
shares of
common stock.
|
(17)
|
Reflects
70,093 shares of common stock and 87,515 warrants to purchase
shares of
common stock.
|
(17)(a)
|
Reflects
70,093 shares of common stock and 70,093 warrants to purchase
shares of
common stock.
|
(18)
|
Reflects
295,766 shares of common stock and 1,172,767 options to purchase
shares of
common stock and 368,815 shares of common stock issuable
upon exercise of
warrants.
|
(18)(a)
|
Reflects
295,766 shares of common stock and 295,766 warrants to purchase
shares of
common stock.
|
(19)
|
Reflects
56,349 options and 36,551 warrants to purchase shares of
common stock and
2,820,576 shares of common stock but does not reflect 147,716
warrants to
purchase shares of common stock because such warrants are
not currently
exercisable within the next 60
days.
|
(19)(a)
|
Reflects
2,820,576 shares of common stock and 14,7716 warrants to
purchase shares
of common stock.
|
(20)
|
Reflects
17,430 shares of common stock and 21,785 warrants to purchase
shares of
common stock.
|
(20)(a)
|
Reflects
17,430 shares of common stock and 17,430 warrants to purchase
shares of
common stock.
|
(21)
|
Reflects
35,865 shares of common stock and 44,775 warrants to purchase
shares of
common stock.
|
(21)(a)
|
Reflects
35,865 shares of common stock and 35,865 warrants to purchase
shares of
common stock.
|
(22)
|
Reflects
89,663 shares of common stock and 111,937 warrants to purchase
shares of
common stock.
|
(22)(a)
|
Reflects
89,663 shares of common stock and 89,663 warrants to purchase
shares of
common stock.
|
(23)
|
Reflects
98,664 shares of common stock and 98,664 warrants to purchase
shares of
common stock.
|
(24)
|
Reflects
126,658 shares of common stock and 157,842 warrants to purchase
shares of
common stock.
|
(24)(a)
|
Reflects
126,658 shares of common stock and 126,658 warrants to purchase
shares of
common stock.
|
(25)
|
Reflects
35,180 shares of common stock and 43,981 warrants to purchase
shares of
common stock.
|
(25)(a)
|
Reflects
35,180 shares of common stock and 35,180 warrants to purchase
shares of
common stock.
|
(26)
|
Reflects
35,401 shares of common stock and 44,311 warrants to purchase
shares of
common stock.
|
(26)(a)
|
Reflects
35,401 shares of common stock and 35,401 warrants to purchase
shares of
common stock.
|
(27)
|
Reflects
2,522,164 shares of common stock and 73,029 warrants to purchase
shares of
common stock..
|
(27)(a)
|
Reflects
2,522,164 shares of common stock and 58,580 warrants to purchase
shares of
common stock
|
(28)
|
Reflects
125,772 shares of common stock, 156,956 warrants to purchase
shares of
common stock and 91,567 options.
|
(28)(a)
|
Reflects
125,772 shares of common stock and 125,772 warrants to purchase
shares of
common stock.
|
(29)
|
Reflects
179,290 shares of common stock, 82,763 options and 112,823
warrants to
purchase shares of common stock.
|
(29)(a)
|
Reflects
179,290 shares of common stock and 90,549 warrants to purchase
shares of
common stock.
|
(30)
|
Reflects
704,365 shares of common stock and 169,048 options to purchase
shares of
common stock.
|
(31)
|
Reflects
1,094,020 shares of common stock and warrants to purchase
672,539 shares
of common stock, all of which securities were received as
compensation in
the ordinary course of business of the
Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(32)
|
Reflects
119,466 shares of common stock and 74,727 warrants to purchase
shares of
common stock, all of which securities were received as compensation
in the
ordinary course of business of the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(33)
|
Reflects
97,561 shares of common stock and 97,561 warrants to purchase
shares of
common stock which securities were purchased in the private
placement. In
addition, includes 187,650 warrants to purchase common stock,
which
securities were received as compensation for consulting services
rendered
to Sunrise Securities Corp., the Company’s Placement Agent. Dr. Filer is a
consultant to Sunrise Securities
Corp.
|
(34)
|
Reflects
2,070 shares of common stock and 2,070 warrants to purchase
shares of
common stock, all of which securities were received as compensation
in the
ordinary course of business of the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(35)
|
Reflects
1,124,253 shares of common stock owned by Mr. Low and warrants
to purchase
761,971 shares of common stock owned by Mr. Low, all of which
securities
were received as compensation in the ordinary course of business
of the
Selling Stockholder’s employer, Sunrise Capital as Placement
Agent.
|
(36)
|
Reflects
80,488 shares of common stock and 73,170 warrants to purchase
shares of
common stock, all of which securities were received as compensation
in the
ordinary course of business of the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(37)
|
Reflects
383,275 shares of common stock and 348,432 warrants to purchase
shares of
common stock. Nathan Low is the sole director and stockholder,
with 100%
beneficial ownership and voting and disposition
rights.
|
(38)
|
Reflects
160,976 shares of common stock and 146,341 warrants to purchase
shares of
common stock, all of which securities were received as compensation
in the
ordinary course of business of the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(38)(a)
|
Sunrise
Foundation Trust is a charitable trust of which Nathan Low,
owner of
Sunrise Securities Corp., is a
trustee.
|
(39)
|
Reflects
60,000 warrants to purchase shares of common
stock.
|
Shares
Owned
|
||||
Name
|
Total
|
%
Before
Offering
|
%
After
Offering
|
Shares
Registered
|
Cornell
Capital Partners LP
101
Hudson Street, Suite 3700
Jersey
City, New Jersey 07302
|
1,966,547(1)
|
4.9%
|
0.0%
(2)
|
47,841,513
(3)
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits Investors;
|
·
|
block
trades in which the broker-dealer will attempt to sell the
shares as agent
but may position and resell a portion of the block as principal
to
facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer
for its
account;
|
·
|
an
exchange distribution in accordance with the rules of the
applicable
exchange;
|
·
|
privately
negotiated transactions;
|
·
|
short
sales provided that the Debenture is fully converted;
|
·
|
broker-dealers
may agree with the Selling Stockholders to sell a specified
number of such
shares at a stipulated price per
share;
|
·
|
a
combination of any such methods of sale;
and
|
·
|
any
other method permitted pursuant to applicable
law.
|
Condensed
Balance Sheet at January 31, 2006 (unaudited)
|
F-1
|
|
Condensed
Statement of Operations for three-month periods ended January 31,
2006
|
||
and
2005 and the period March 1, 2002 (inception) to January 31, 2006
(unaudited)
|
F-2
|
|
Condensed
Cash Flow Statements for three-month periods ended January 31,
2006
|
||
and
2005 and the period March 1, 2002 (inception) to January 31, 2006
(unaudited)
|
F-3
|
|
Notes
to Condensed Financial Statements
|
F-5
- F-11
|
|
Report
of Independent Registered Public Accounting Firm
|
F-12
|
|
Balance
Sheet as of October 31, 2005
|
F-13
|
|
Statement
of Operations for year ended December 31, 2003, ten month period
ended
October
31, 2004, year ended October 31, 2005 and period from March 1,
2002
(inception)
to October 31, 2005
|
F-14
|
|
Statement
of Shareholders' Equity (Deficiency) for period from March 1, 2002
(inception)
to October 31, 2005
|
F-15
|
|
Statement
of Cash Flows for year ended December 31, 2003, ten month period
ended
October
31, 2004, year ended October 31, 2005 and period from March 1,
2002
(inception)
to October 31, 2005
|
F-17
|
|
Notes
to Financial Statements
|
F-19
- F-28
|
January
31,
|
||||
2006
|
||||
(Unaudited)
|
||||
ASSETS
|
||||
Current
Asset - Cash
|
$
|
1,805,640
|
||
Property
and Equipment (net of accumulated depreciation of $11,513)
|
71,166
|
|||
Intangible
Assets (net of accumulated amortization of $62,817)
|
765,245
|
|||
Other
Assets
|
4,600
|
|||
TOTAL
ASSETS
|
$
|
2,646,651
|
||
LIABILITIES
& SHAREHOLDERS’ EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
Payable
|
$
|
686,570
|
||
Notes
Payable - current portion
|
58,585
|
|||
Total
Current Liabilities
|
745,155
|
|||
Notes
Payable - net of current portion
|
443,000
|
|||
|
||||
Total
Liabilities
|
1,188,155
|
|||
Shareholders’
Equity:
|
||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued
and
outstanding 38,167,028
|
38,167
|
|||
Additional
Paid-In Capital
|
5,342,898
|
|||
|
||||
Deficit
Accumulated During the Development Stage
|
(3,922,569
|
)
|
||
Total
Shareholders' Equity
|
1,458,496
|
|||
TOTAL
LIABILITIES & SHAREHOLDERS’ EQUITY
|
$
|
2,646,651
|
3
Months ended
January
31,
2006
|
3
Months ended
January
31,
2005
|
Period
from March 1
2002
(Inception) to January 31,
2006
|
||||||||
Revenue
|
$
|
329,928
|
$
|
0
|
$
|
1,003,202
|
||||
Research
& Development Expenses
|
385,107
|
218,951
|
2,228,991
|
|||||||
General
& Administrative Expenses
|
413,883
|
26,175
|
2,680,614
|
|||||||
Total
Operating Expenses
|
798,990
|
245,126
|
4,909,605
|
|||||||
Interest
Expense
|
1,008
|
2,968
|
29,736
|
|||||||
Other
Income
|
11,931
|
2,739
|
57,454
|
|||||||
Net
Loss
|
(458,139
|
)
|
(245,355
|
)
|
(3,878,685
|
)
|
||||
Dividends
Attributable to preferred shares
|
--
|
--
|
43,884
|
|||||||
Net
Loss Applicable to Common Stock
|
$
|
(458,139
|
)
|
$
|
(245,355
|
)
|
$
|
(3,922,569
|
)
|
|
Net
Loss per share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.18
|
)
|
|
Weighted
Average Number of Shares Outstanding basic and diluted
|
37,761,557
|
31,271,317
|
22,166,817
|
3
Months ended
January
31,
2006
|
3
Months ended
January
31,
2005
|
Period
from March 1, 2002
(Inception)
to January 31,
2006
|
||||||||
OPERATING
ACTIVITIES
|
||||||||||
Net
Loss
|
$
|
(458,139
|
)
|
$
|
(245,355
|
)
|
$
|
(3,878,685
|
)
|
|
Adjustments
to reconcile Net Loss
|
||||||||||
to
net cash used in operations:
|
||||||||||
Value
assigned to options given as payments to consultants and
employees
|
52,190
|
141,407
|
||||||||
Non-Cash
Charges
|
112,870
|
279,647
|
||||||||
Accrued
Interest on Notes Payable
|
1,008
|
7,968
|
13,316
|
|||||||
Value
of Penalty Shares Issued
|
117,498
|
|||||||||
Depreciation
Expense
|
4,081
|
11,513
|
||||||||
Amortization
expense
|
10,159
|
6,817
|
62,817
|
|||||||
Increase
in other assets
|
(2,450
|
)
|
(4,600
|
)
|
||||||
Increase
(Decrease) in Accounts Payable
|
34,683
|
(356,756
|
)
|
1,001,776
|
||||||
Net
cash used in Operating Activities
|
(243,148
|
)
|
(589,776
|
)
|
(2,255,311
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
(44,940
|
)
|
(44,940
|
)
|
||||||
Purchase
of Property and Equipment
|
(2,102
|
)
|
(82,679
|
)
|
||||||
Cost
of intangible assets
|
(24,316
|
)
|
(203,460
|
)
|
(740,981
|
)
|
||||
Net
cash used in Investing Activities
|
(26,418
|
)
|
(248,400
|
)
|
(868,600
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from Notes Payable
|
671,224
|
|||||||||
Net
Proceeds of Issuance of Preferred Stock
|
235,000
|
|||||||||
Net
Proceeds of Issuance of Common Stock
|
--
|
4,023,327
|
4,023,327
|
|||||||
Net
cash provided by Financing Activities
|
--
|
4,023,327
|
4,929,551
|
|||||||
Net
increase (decrease) in cash
|
(269,566
|
)
|
3,185,151
|
1,805,640
|
||||||
Cash
at beginning of period
|
2,075,206
|
32,279
|
||||||||
Cash
at end of period
|
$
|
1,805,640
|
$
|
3,217,430
|
$
|
1,805,640
|
SUPPLEMANTAL
SCHEDULE OF NONCASH INVESTING AND FINANCING
ACTIVITIES:
|
||||||||||
3
Months ended
January
31,
2006
|
3
Months ended
January
31,
2005
|
Period
from March 1, 2002
(Inception)
to
January
31, 2006
|
||||||||
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
|
$
|
613,158
|
$
|
613,158
|
||||||
Intangible
Assets Acquired with Notes Payable
|
$
|
360,000
|
1.
|
Business
description
|
2.
|
Stock-based
Employee Compensation
Expense
|
|
Three
months ended
January
31, 2005
|
|||
Net
loss, as reported
|
$
|
(245,355
|
)
|
|
Add:
Stock-based employee compensation expense included in reported
net
loss
|
0
|
|||
Deduct:
Total stock-based employee compensation expense determined
under fair
value based method for all awards
|
(18,573
|
)
|
||
Pro
forma net loss
|
$
|
(263,928
|
)
|
|
Net
loss per share amounts; basic and diluted:
|
|
|||
As
reported
|
$
|
(0.01
|
)
|
|
Pro
forma
|
$
|
(0.01
|
)
|
|
|
2006
|
Expected
volatility
|
|
30%
|
Expected
Life
|
|
9+
years
|
Dividend
yield
|
|
0
|
Risk-free
interest rate
|
|
4.39
|
Shares
|
Weighted
Average
Exercise
Price
|
Remaining
Life
Years
|
Aggregate
Intrinsic
Value
|
||||||||||
Balance
at beginning of period
|
4,842,539
|
$
|
0.27
|
|
|
||||||||
Granted
|
1,233,179
|
$
|
0.22
|
|
|
||||||||
Cancelled
or Expired
|
(116,641
|
)
|
$
|
0.37
|
|
|
|||||||
Exercised
|
—
|
—
|
|
|
|||||||||
Outstanding
at end of period
|
5,959,078
|
$
|
0.26
|
8
|
$
|
0
|
|
Number
of
Shares
|
Weighted-
Average
Fair
Value
at
Grant
Date
|
Weighted-
Average
Remaining
Contractual
Term
(in
years)
|
|||||||
Non-vested
shares at October 31, 2005
|
2,386,542
|
$
|
0.29
|
8.5
|
||||||
Options
granted
|
988,766
|
$
|
0.22
|
10.0
|
||||||
Options
vested
|
(316,448
|
)
|
$
|
0.25
|
8.5
|
|||||
Options
forfeited or expired
|
—
|
$
|
—
|
—
|
||||||
Non-vested
shares at January 31, 2006
|
3,058,860
|
$
|
0.26
|
8.6
|
3.
|
Subsequent
Event:
|
ADVAXIS,
INC.
|
||||
(a
development stage company)
|
||||
BALANCE
SHEET
|
||||
October
31,
|
||||
2005
|
||||
ASSETS
|
||||
Current
Asset - cash
|
$
|
2,075,206
|
||
Fixed
Assets (net of depreciation)
|
73,145
|
|||
Intangible
Assets (net of amortization)
|
751,088
|
|||
Other
Assets
|
4,600
|
|||
Total
Assets
|
$
|
2,904,039
|
||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
651,887
|
||
Notes
payable, current portion
|
57,577
|
|||
Total
current liabilities
|
709,464
|
|||
Notes
Payable, net of current portion
|
443,000
|
|||
Total
liabilities
|
1,152,464
|
|||
Commitments
and Contingencies
|
||||
Shareholders'
Equity (Deficiency):
|
||||
Common
stock - $0.001 par value; authorized 500,000,000
|
||||
shares,
issued and outstanding 37,686,427 shares at October
31, 2005
|
37,686
|
|||
Additional
paid-in capital
|
5,178,319
|
|||
Deficit
accumulated during the development stage
|
(3,464,430
|
)
|
||
|
||||
Shareholders'
equity
|
1,751,575
|
|||
Total
Liabilities and Shareholders' Equity
|
$
|
2,904,039
|
ADVAXIS,
INC.
|
|||||||||||||
(a
development stage company)
|
|||||||||||||
STATEMENT
OF OPERATIONS
|
|||||||||||||
Year
ended
December
31,
|
Ten
Month
Period
ended
October
31,
|
Year
ended
October
31,
|
Period
from
March
1,
2002
(inception)
to
October
31,
|
||||||||||
2003
|
2004
|
2005
|
2005
|
||||||||||
Revenue
|
$
|
4,000
|
$
|
116,406
|
$
|
552,868
|
$
|
674,297
|
|||||
Research
and development expenses
|
$
|
491,508
|
125,942
|
1,175,536
|
1,843,884
|
||||||||
General
and administrative expenses
|
405,568
|
524,368
|
1,219,792
|
2,266,731
|
|||||||||
Interest
Income (expense)
|
(17,190
|
)
|
(4,229
|
)
|
36,671
|
15,251
|
|||||||
Other
income
|
521
|
57
|
521
|
||||||||||
|
|||||||||||||
Net
loss
|
(909,745
|
)
|
(538,076
|
)
|
(1,805,789
|
)
|
(3,420,546
|
)
|
|||||
Dividends
attributed to preferred stock
|
43,884
|
43,884
|
|||||||||||
Net
loss applicable to common stock
|
$
|
(909,745
|
)
|
$
|
(581,960
|
)
|
$
|
(1,805,789
|
)
|
$
|
(3,464,430
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
($0.04
|
)
|
($0.05
|
)
|
||||||
Weighted-average
number of shares; basic and diluted
|
15,597,723
|
15,597,723
|
35,783,666
|
ADVAXIS,
INC.
|
||||||||||||||||||||||
(a
development stage company)
|
||||||||||||||||||||||
STATEMENT
OF SHAREHOLDERS' EQUITY (DEFICIENCY)
|
||||||||||||||||||||||
Period
from March 1, 2002 (inception) to October 31,
2005
|
||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in Capital
|
Deficit
Accumulated During the Development Stage
|
Shareholders'
Equity (Deficiency)
|
||||||||||||||||||
|
Number
of Shares Outstanding
|
Amount
|
Number
of shares outstanding
|
Amount
|
|
|
|
|||||||||||||||
Preferred
stock issued
|
3,418.18
|
$
|
235,000
|
$
|
235,000
|
|||||||||||||||||
Common
Stock Issued
|
40,000
|
40
|
(40
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
10,493
|
10,493
|
||||||||||||||||||||
Net
Loss
|
(166,936
|
)
|
(166,936
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect recapitalization on
November
12, 2004
|
(-3,418.18
|
)
|
(-235,000
|
)
|
15,557,723
|
15,558
|
219,442
|
|
||||||||||||||
Balance
at December 31, 2002
|
15,597,723
|
15,598
|
229,895
|
(166,936
|
)
|
78,557
|
||||||||||||||||
Note
payable converted into preferred stock
|
232.27
|
15,969
|
15,969
|
|||||||||||||||||||
Options
granted to consultants and professionals
|
8,484
|
8,484
|
||||||||||||||||||||
Net
loss
|
(909,745
|
)
|
(909,745
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect recapitalization on
November
12, 2004
|
(-232.27
|
)
|
(-15,969
|
)
|
|
|
15,969
|
|
|
|||||||||||||
Balance
at December 31, 2003
|
-
0 -
|
-
0 -
|
15,597,723
|
15,598
|
254,348
|
(1,076,681
|
)
|
(806,735
|
)
|
|||||||||||||
Stock
dividend on preferred stock
|
638.31
|
43,884
|
(43,884
|
)
|
||||||||||||||||||
Net
loss
|
(538,076
|
)
|
(538,076
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
5,315
|
5,315
|
||||||||||||||||||||
Retroactive
restatement to reflect recapitalization on
November
12, 2004
|
(638.31
|
)
|
(43,884
|
)
|
|
|
43,884
|
|
|
|||||||||||||
Balance
at October 31, 2004
|
-
0 -
|
-
0 -
|
15,597,723
|
15,598
|
303,547
|
(1,658,641
|
)
|
(1,339,496
|
)
|
ADVAXIS,
INC.
|
|||||||
(a
development stage company)
|
|||||||
STATEMENT
OF SHAREHOLDERS' EQUITY
(DEFICIENCY)
|
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in
Capital
|
Deficit
Accumulated
During
the Development
Stage
|
Shareholders'
Equity
(Deficiency)
|
||||||||||||||||||
Number
of
Shares
Outstanding
|
Amount
|
Number
of
shares
outstanding
|
Amount
|
|||||||||||||||||||
Common
Stock issued to
Placement
Agent on recapitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Effect
of recapitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Options
granted to consultants
and
professionals
|
64,924
|
64,924
|
||||||||||||||||||||
Conversion
of Note payable
to
Common Stock
|
2,136,441
|
2,136
|
611,022
|
613,158
|
||||||||||||||||||
Issuance
of Common Stock
for
cash, net of shares
to
Placement Agent
|
17,450,693
|
17,451
|
4,335,549
|
4,353,000
|
||||||||||||||||||
Issuance
of common stock
to
consultants
|
586,970
|
587
|
166,190
|
166,777
|
||||||||||||||||||
Issuance
of common stock
in
connection with the
registration
statement
|
409,401
|
408
|
117,090
|
117,498
|
||||||||||||||||||
Issuance
Costs
|
(329,673
|
)
|
(329,673
|
)
|
||||||||||||||||||
Net
loss
|
(1,805,789
|
)
|
(1,805,789
|
)
|
||||||||||||||||||
Restatement
to reflect
recapitalization
on
November
12, 2004
including
cash paid of $44,940
|
|
|
|
|
(88,824
|
)
|
|
(88,824
|
)
|
|||||||||||||
Balance
at October 31, 2005
|
$
|
-
0 -
|
$
|
-
0 -
|
37,686,428
|
37,686
|
5,178,319
|
(3,464,430
|
)
|
1,751,575
|
ADVAXIS,
INC.
|
|||||||||
(a
development stage company)
|
|||||||||
STATEMENT
OF CASH FLOWS
|
Year
ended
December
31, 2003 |
Tenth
Month
Period
ended
October
31,
2004
|
Year
ended
October
31,
2005
|
Period
from
March
1, 2002 (inception) to
October
31,
2005
|
||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net loss
|
$
|
(909,745
|
)
|
$
|
(538,076
|
)
|
$
|
(1,805,789
|
)
|
$
|
(3,420,546
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
|||||||||||||
Value
assigned to options given as payment to consultants and
professionals
|
8,484
|
5,315
|
64,924
|
89,217
|
|||||||||
Amortization
expense
|
3,171
|
15,818
|
33,669
|
52,658
|
|||||||||
Depreciation
expense
|
7,432
|
7,432
|
|||||||||||
Accrued
interest on Notes Payable
|
12,308
|
12,308
|
|||||||||||
Non
cash Charges
|
166,777
|
166,777
|
|||||||||||
Value
of Penalty Shares Issued
|
117,498
|
117,498
|
|||||||||||
Increase
in Other Assets
|
(4,600
|
)
|
(4,600
|
)
|
|||||||||
Increase
(decrease) in accounts payable
|
933,111
|
80,307
|
(132,149
|
)
|
967,093
|
||||||||
Net
cash provided by (used in) operating activities
|
35,021
|
(436,636
|
)
|
(1,539,930
|
)
|
(2,012,163
|
)
|
CASH FLOWS USED IN INVESTING ACTIVITIES: | |||||||||||||
Cash
paid on acquisition of Great Expectations
|
(44,940
|
)
|
(44,940
|
)
|
|||||||||
Cost
of Furniture & Equipment
|
(80,577
|
)
|
(80,577
|
)
|
|||||||||
Cost
of Intangible Assets
|
(277,243
|
)
|
(124,469
|
)
|
(314,953
|
)
|
(716,665
|
)
|
|||||
Net
cash used in Investing Activities
|
(277,243
|
)
|
(124,469
|
)
|
(440,470
|
)
|
(842,182
|
)
|
|||||
Cash
flows from financing activities:
|
|||||||||||||
Proceeds
from notes payable
|
85,000
|
546,224
|
671,224
|
||||||||||
Net
proceeds on issuance of preferred stock
|
235,000
|
||||||||||||
Net
Proceeds on Issuance of Common Stock
|
4,023,327
|
4,023,327
|
|||||||||||
Cash
provided by financing activities
|
85,000
|
546,224
|
4,023,327
|
4,896,732
|
|||||||||
Net
increase (decrease) in cash
|
(157,222
|
)
|
(14,881
|
)
|
2,042,927
|
2,075,206
|
|||||||
Cash
at beginning of period
|
204,382
|
47,160
|
32,279
|
||||||||||
|
|||||||||||||
Cash
at end of period
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
$
|
2,075,206
|
SUPPLEMENTAL
SCHEDULE OF NONCASH INVESTING
AND
FINANCING ACTIVITIES:
|
|||||||||||||
Common
Stock issued to founders
|
$
|
40
|
|||||||||||
Notes
Payable and Accrued Interest Converted to Preferred Stock
|
$
|
15,969
|
$
|
15,969
|
|||||||||
Stock
Dividend on Preferred Stock
|
$
|
43,884
|
$
|
43,884
|
|||||||||
Notes
Payable and Accrued Interest Converted to Common
|
$
|
613,158
|
$
|
613,158
|
|||||||||
Intangible
Assets Acquired with Notes Payable
|
$
|
360,000
|
$
|
360,000
|
1. PRINCIPAL
BUSINESS ACTIVITY
AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
|
Advaxis,
Inc. (the "Company") was incorporated in 2002 and is a biotechnology
company researching and developing new cancer-fighting techniques.
The
Company is in the development stage and its operations are subject
to all
of the risks inherent in an emerging business enterprise.
As
shown in the financial statements, the Company has incurred losses
from
operations, which raise doubt as to the ability of the Company
to continue
as a going concern. Although we believe that the net proceeds received
by
us from the Private Placement and the private offerings will be
sufficient
to finance our currently planned operations for approximately the
next 12
to 24 months, we do not believe that these amounts will be sufficient
to
meet our longer-term cash requirements or our cash requirements
for the
commercialization of any of our existing or future product candidates.
We
will be required to issue equity or debt securities or to enter
into other
financial arrangements, including relationships with corporate
and other
partners, in order to raise additional capital. Depending upon
market
conditions, we may not be successful in raising sufficient additional
capital for our long-term requirements. In such event, our business,
prospects, financial condition and results of operations could
be
materially adversely affected.
In
accordance with Securities and Exchange Commission (SEC) Staff
Accounting
Bulletin (SAB) No. 104, revenue from license fees and grants is
recognized
when the following criteria are met: persuasive evidence of an
arrangement
exists, services have been rendered, the contract price is fixed
or
determinable, and collectibility is reasonably assured. In licensing
arrangements, delivery does not occur for revenue recognition purposes
until the license term begins. Nonrefundable upfront fees received
in
exchange for products delivered or services performed that do not
represent the culmination of a separate earnings process will be
deferred
and recognized over the term of the agreement using the straightline
method or another method if it better represents the timing and
pattern of
performance. Since its inception and through October 31, 2005,
all of the
Company’s revenues have been from grants. For the year ended October 31,
2005, 77% and 13% of the Company’s revenues were received from two grants,
respectively. For the ten month period ended October 31, 2004,
all of the
Company’s revenue was received from one grant.
For
revenue contracts that contain multiple elements, the Company will
determine whether the contract includes multiple units of accounting
in
accordance with EITF No. 00-21, Revenue
Arrangements with Multiple Deliverables.
Under that guidance, revenue arrangements with multiple deliverables
are
divided into separate units of accounting if the delivered item
has value
to the customer on a standalone basis and there is objective and
reliable
evidence of the fair value of the undelivered item.
The
Company maintains its cash in bank deposit accounts which, at times,
may
exceed federally insured limits.
Intangible
assets, which consist primarily of legal costs in obtaining trademarks
and
patents, are being amortized on a straight-line basis over 20
years.
|
|
The
Company reviews long-lived assets for impairment whenever
events or
changes in circumstances indicate that the carrying amount
of an asset may
not be recoverable. An asset is considered to be impaired
when the sum of
the undiscounted future net cash flows expected to result
from the use of
the asset and its eventual disposition exceeds its carrying
amount. The
amount of impairment loss, if any, is measured as the difference
between
the net book value of the asset and its estimated fair value.
Basic
loss per share is computed by dividing net loss by the weighted-average
number of shares of common stock outstanding during the periods.
Diluted
earnings per share gives effect to dilutive options, warrants
and other
potential common stock outstanding during the period. Potential
common
stock has not been included in the computation of diluted
loss per share,
as the effect would be antidilutive.
Deferred
income taxes are provided for the differences between the
bases of assets
and liabilities for financial reporting and income tax purposes.
A
valuation allowance is established when necessary to reduce
deferred tax
assets to the amount expected to be realized.
The
preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America
requires the
use of estimates by management. Actual results could differ
from these
estimates.
The
estimated fair value of the notes payable approximates the
carrying amount
based on the rates available to the Company for similar debt.
Accounts
payable consists entirely of trade accounts payable.
Research
and development costs are charged to expense as incurred.
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 123R,
“Share-Based Payment,” which establishes standards for the Accounting for
transactions in which an entity exchanges its equity instruments
for goods
or services. A key provision of this statement is the requirement
of a
public entity to measure the cost of employee services received
in
exchange for an award of equity instruments, including stock
options,
based on the grant-Dale fair market value of the award. That
cost will be
recognized over a period during which an employee is required
to provide
services in exchange for the award. This standard becomes
effective in the
Company’s net fiscal quarter. The Company cannot estimate the future
impact on the financial statements from the implementation
SFAS No.
123R.
Management
does not believe that any other recently issued, but not
yet effective,
accounting standards if currently adopted would have a material
effect on
the accompanying financial statements.
The
Company has elected to apply APB Opinion No. 25 and related
interpretations in accounting for its stock options granted
to employees
and has adopted the disclosure-only provisions of SFAS No.
123. Had the
Company elected to recognize compensation cost based on the
fair value of
the options granted at the grant date as prescribed by SFAS
No. 123, the
Company's net loss would have been as follows:
|
Year
ended
December
31, 2003
|
10
months ended October 31, 2004
|
Year
ended
October
31
2005
|
March
1, 2002 (date of inception) to October 31, 2005
|
Net
Loss as reported
|
$
|
(909,745
|
)
|
$
|
(538,076
|
)
|
$
|
(1,805,789
|
)
|
$
|
(3,420,546
|
)
|
|
Add:
Stock based option expense included in recorded net income
|
8,484
|
5,315
|
64,924
|
89,217
|
|||||||||
Deduct
stock option compensation expense determined under fair value
based
method
|
(41,407
|
)
|
$
|
(75,334
|
)
|
$
|
(200,942
|
)
|
$
|
(328,176
|
)
|
||
Adjusted
Net Loss
|
$
|
(942,668
|
)
|
$
|
(608,095
|
)
|
($1,941,807
|
)
|
$
|
(3,659,505
|
)
|
||
Net
Loss per share as reported
|
$
|
(0.06
|
)
|
$
|
(0.04
|
)
|
($0.05
|
)
|
|||||
Net
Loss per share pro forma
|
$
|
(0.06
|
)
|
$
|
(0.04
|
)
|
($0.05
|
)
|
|
The
Company accounts for nonemployee stock-based awards in
which goods or
services are the consideration received for the equity
instruments issued
based on the fair value of the equity instruments in accordance
with the
guidance provided in the consensus opinion of the Emerging
Issues Task
Force ("EITF") Issue 96-18, Accounting
for Equity Instruments that Are Issued to Other than Employees
for
Acquiring, or in Conjunction With Selling Goods or
Services.
|
2. INTANGIBLE
ASSETS:
|
Intangible
assets consist of the following at October 31,
2005:
|
Trademarks
|
$
|
51,700
|
||
Patents
|
263,752
|
|||
License
|
485,123
|
|||
Less:
Accumulated Amortization
|
(49,487
|
)
|
||
$
|
751,088
|
|
Estimated
amortization expense is as
follows:
|
Year
ending October 31,
|
||||
2006
|
$
|
40,029
|
||
2007
|
40,029
|
|||
2008
|
40,029
|
|||
2009
|
40,029
|
|||
2010
|
40,029
|
|
Amortization
expense of intangibles amounted to $33,669 and $15,818
for the year ended
October 31, 2005 and the ten-month period ended October
31, 2004,
respectively.
|
3. NOTES
PAYABLE:
|
Notes
payable consist of the following at October 31,
2005:
|
Two
notes payable with interest at 8% per annum, due on December
17, 2008.
The
lender has served notice demanding payment pursuant to the November
2004
recapitalization and financing
|
57,577
|
|||
Note
payable with no interest payable at the time of the closing of
the
Company’s contemplated $5,000,000 equity financing.
|
75,000
|
|||
Note
payable with no interest payable at the time of the closing of
the
Company’s contemplated $5,000,000 equity financing.
|
8,000
|
|||
Note
payable with no interest payable at December 15, 2006, or at
the time of
the closing of the Company’s contemplated $5,000,000 equity
financing
|
130,000
|
|||
Note
payable with no interest payable at December 15, 2007 or at the
time of
the closing of the Company’s contemplated $8,000,000 equity financing
|
230,000
|
|||
500,577
|
||||
Less
current portion
|
57,577
|
|||
$
|
443,000
|
|
Aggregate
maturities of notes payable at October 31, 2005 are as
follows:
|
Year
ending December 31,
|
||||
2005
|
57,577
|
|||
2006
|
213,000
|
|||
2007
|
230,000
|
|||
$
|
500,577
|
4. STOCK
OPTIONS:
|
The
Company has adopted the Advaxis, Inc. 2002 Stock Option Plan (the
"Plan"),
which allows for grants up to 8,000 shares of the Company's common
stock.
This Plan was replaced by the Advaxis 2004 Option Plan, which allows
for
grants up to 2,381,525 shares of the Company's common stock. The
board of
directors adopted the 2005 stock option plan, which allows for
grants up
to 5,600,000 shares of the Company's common stock. The 2005 plan
is
subject to the approval of the Company’s shareholders. The 2004 plan is
and the 2005 plan is to be administered and interpreted by the
Company's
board of directors.
Stock
option activity during the periods indicated is as
follows:
|
2004
Plan
|
2005
Plan
|
Total
|
|||||||||||||||||
Options
Granted
Under
the
2004
Plan
|
Weighted
Average
Exercise
Price
|
Options
Granted
Under
the
2005
Plan
|
Weighted
Average
Exercise
Price
|
Options
Granted
|
Weighted
Average
Exercise
Price
|
||||||||||||||
January
1, 2003
|
1,172,767
|
$
|
0.20
|
1,172,767
|
$
|
0.20
|
|||||||||||||
Granted
|
1,084,085
|
1,084,085
|
|||||||||||||||||
Outstanding
at December 31, 2003
|
2,256,852
|
$
|
0.22
|
2,256,852
|
$
|
0.22
|
|||||||||||||
Granted
|
132,419
|
132,419
|
|||||||||||||||||
Outstanding
at October 31, 2004
|
2,389,271
|
$
|
0.23
|
2,389,271
|
$
|
0.23
|
|||||||||||||
Granted
|
283,730
|
$
|
0.20
|
2,958,817
|
$
|
0.29
|
3,242,547
|
$
|
0.29
|
||||||||||
Forfeited
|
532,602
|
$
|
0.20
|
256,677
|
$
|
0.29
|
789,279
|
$
|
0.23
|
||||||||||
Outstanding
at October 31, 2005
|
2,140,399
|
$
|
0.24
|
2,702,140
|
$
|
0.29
|
4,842,539
|
$
|
0.27
|
||||||||||
Vested
and exercisable at October 31, 2005
|
1,715,496
|
$
|
0.24
|
740,501
|
$
|
0.29
|
2,455,997
|
$
|
0.25
|
|
At
October 31, 2005, the weighted exercise prices and
weighted-average
remaining contractual life of outstanding options were
$0.25 and 9 years,
respectively.
The
fair value of each option is estimated on the date
of grant using the
Black-Scholes option-pricing model with the following
assumptions used for
grants in 2004, 2003 and 2002: dividend yield of 0%;
average risk-free
interest rates of 6%; volatility of 30%; and an expected
life of 10 years
in each year.
On
November 12, 2004, in connection with the recapitalization
(see Note 8),
the options granted under the 2003 option plan were
canceled, and
employees and consultants were granted options of Advaxis
under the 2004
plan. The cancellation and replacement had no accounting
consequence since
the aggregate intrinsic value of the options immediately
after the
cancellation and replacement was not greater than the
aggregate intrinsic
value immediately before the cancellation and replacement,
and the ratio
of the exercise price per share to the fair value per
share was not
reduced. Additionally, the original options were not
modified to
accelerate vesting or extend the life of the new options.
The table
provided in this Note 4 reflects the options on a post
recapitalization
basis.
|
5. SHAREHOLDERS'
EQUITY:
|
Prior
to the recapitalization (see Note 8), the Company had convertible
preferred stock with $.001 par value and 50,000 shares authorized.
6,000
of those shares were designated as Series A and 3,418.18, 3,650.45,
and
3.640.45 were issued and outstanding at December 31, 2002, December
31,
2003 and October 31, 2004, respectively. The Company also had 100,000
shares authorized of $.001
par value common stock with 40,000 shares issued and outstanding
at
December 31, 2002 and 2003, and at October 31, 2004.
The
preferred stock and common stock amounts were retroactively restated
to
reflect the effects of the recapitalization on November 12, 2004
(see Note
8).
|
6.
COMMITMENTS
AND CONTINGENCIES:
|
Pursuant
to multiple consulting agreements and a licensing agreement, the
Company
is contingently liable for the following:
The
Company is obligated to pay $75,000 to its former patent counsel
upon
receiving financing of $5,000,000 or greater.
The
Company is obligated to pay $8,000 to a consultant upon receiving
equity
financing of $5,000,000 or greater.
|
Under
a license agreement, the Company is obligated to pay (a) $525,000
in
aggregate, divided over a four-year period as a minimum royalty
after the
first commercial sale of a product. Such payments are not anticipated
within the next five years. (b) The Company is also obligated to
pay after
the 6th anniversary of the licensing agreement, annual license
maintenance
fees of $125,000 per year. (c) Upon the achievement of the first
sale of a
product in certain fields, the Company shall be obligated to pay
certain
milestone payments, as follows: $2,500,000 shall be due for first
commercial sale of the first product in the cancer field (of which
$1,000,000 shall be paid within forty-five (45) days of the date
of the
first commercial sale, $1,000,000 shall be paid on the first anniversary
of the first commercial sale; and $500,000 shall be paid on the
second
anniversary of the date of the first commercial sale). In addition,
$1,000,000 shall be due and payable within forty-five (45) days
following
the date of the first commercial sale of a product in any of the
following
fields (a) Infectious Disease, (b) Allergy, (c) Autoimmune Disease,
and
(d) any other therapeutic indications for which licensed products
are
developed. Therefore, the maximum total potential amount of milestone
payments is $6,500,000. Such milestone payments are not expected
prior to
obtaining a regulatory approval to market and sell the Company’s vaccines,
and such regulatory approval is not expected within the next 5
years.
Under
a consulting agreement with the Company’s scientific inventor, the Company
is obligated to pay $3,000 per month until the Company closes a
$3,000,000
equity financing, $5,000 per month pursuant to a $3,000,000 equity
financing, $7,000 per month pursuant to a $6,000,000 equity financing,
and
$9,000 per month pursuant to a $9,000,000 equity
financing.
|
|
Pursuant
to a Clinical Research Service Agreement, the Company is
obligated to pay
$430,000 to a vendor, of which $215,000 shall be paid pursuant
to
$5,000,000 equity financing.
The
Company is obligated under a noncancelable operating lease
for laboratory
and office space expiring in May 2006 with aggregate future
minimum
payments due amounting to $11,500.
J.
Todd Derbin, the President and Chief Executive Officer of the
Company,
have entered into a Termination of Employment Agreement effective
December
31, 2005 pursuant to which Mr. Derbin’s employment by the Company will end
on December 31, 2005. Pursuant to such agreement Mr. Derbin’s salary for
2005 is set at $225,000 plus a bonus for 2005 of $5,000 in
shares of
Common Stock of the Company priced at $0.287 per share. Following
his
resignation Mr. Derbin shall service as a consultant to the
Company for a
fee of $6,250 per month for 6 months ending June 30, 2006.
Mr. Derbin will
continue to serve as Chairman and a member of the Board of
directors of
the Company until at least September 30, 2006.
The
Company has entered into a consulting agreement with LVEP Management
LLC
(LVEP) dated as of January 19, 2005, and amended on April 15,
2005, and
October 31, 2005, pursuant to which Mr. Roni Appel will serve
as Chief
Executive Officer of the Company. LVEP is owned by Scott Flamm,
one of our
directors and a principal shareholder. LVEP employs Mr. Flamm
and Mr.
Appel. The initial term of the Consulting Agreement as amended
is until
December 31, 2007 and thereafter the term of the agreement
shall be
automatically extended for one year periods unless we notify
LVEP at least
60 days prior to the end of term of our intent not to extend.
In addition,
the Consulting Agreement may be terminated by the Company for
any reason
upon 60 days prior notice or by LVEP upon 45 days prior notice.
Upon such
notice all compensation and bonuses payable under the Consulting
Agreement
shall continue until the later to occur of the end of the term
or twelve
(12) months from such termination. Under the Consulting Agreement
as
amended LVEP shall receive compensation of $250,000 per year
payable at
the rate of $20,833.33 per month for the term of the agreement
plus
reimbursement of approved expenses in connection with providing
the
consulting services. LVEP intends to pay all such compensation
to Mr.
Appel. The Consultant will receive a bonus payment at the end
of 2005 not
to exceed $75,000. In subsequent years the bonus shall equal
40% of the
base consulting compensation. At the election of the Company
up to 50% and
at the election of Consultant up to 100% of the bonus may be
paid in
common stock of the Company. Additionally, LVEP shall receive
additional
options to purchase common stock of the Company bringing options
held by
LVEP to 5% of the outstanding shares and options of the Company
as of
December 31, 2005. The incremental options are to vest monthly
over four
years commencing in April, 2006. LVEP has assigned such options
to Mr.
Appel.
The
Company entered into an employment agreement with Dr. Vafa
Shahabit PhD to
become Head of Director of Science effective March 1, 2005,
terminable on
30 days notice. The compensation is $100,000 per annum with
a potential
bonus of $20,000. In addition, Dr. Shahabit will be granted
150,000
options.
|
7. INCOME
TAXES:
|
The
Company entered into an employment agreement with Dr. John Rothman,
PhD to
become Vice President of Clinical Development effective March
7, 2005 for
a term of one year ending February 28, 2006 and terminable on
30 days
notice. His compensation is $170,000 per annum, to increase to
$180,000
upon the closing of a $15 million equity financing. Upon meeting
incentives to be set by the Company, he will receive a bonus
of up to
$45,000. In addition, Dr. Rothman will be granted 360,000 stock
options.
The
Company is involved in various claims and legal actions arising
in the
ordinary course of business. Management is of the opinion that
the
ultimate outcome of these matters would not have a material adverse
impact
on the financial position of the Company or the results of its
operations.
The
Company has a net operating loss carryforward of approximately
$2,619,000
at October 31, 2005 available to offset taxable income through
2025.
The
tax effects of loss carry forwards give rise to a deferred tax
asset and a
related valuation allowance at October 31, 2005 as
follows:
|
Net
operating losses
|
$
|
1,047,593
|
||
Less
valuation allowance
|
(1,047,593
|
)
|
||
Deferred
tax asset
|
$
|
-
0 -
|
|
The
difference between income taxes computed at the statutory federal
rate of
34% and the provision for income taxes relates to the
following:
|
Ten-month
|
Twelve-month
|
Period
from
|
||||
Year
ended
|
period
ended
|
period
ended
|
March
1, 2002
|
|||
December
31,
|
October
31,
|
October
31,
|
(inception)
to
|
|||
2003
|
2004
|
2005
|
October
31,
|
|||
2005
|
||||||
Provision
at federal statutory rate
|
34%
|
34%
|
34%
|
34%
|
||
Valuation
allowance
|
(34)
|
(34)
|
(34)
|
(34)
|
||
-0-%
|
-0-%
|
-0-%
|
-0-%
|
8.
RECAPITALIZATION:
|
On
November 12, 2004, Great Expectations and Associates, Inc. ("Great
Expectations") acquired the Company through a share exchange and
reorganization (the "Recapitalization"), pursuant to which the
Company
became a wholly owned subsidiary of Great Expectations. Great Expectations
acquired (i) all of the issued and outstanding shares of common
stock of
the Company and the Series A preferred stock of the Company in
exchange
for an aggregate of 15,597,723 shares of authorized, but theretofore
unissued, shares of common stock, no par value, of Great Expectations;
(ii) all of the issued and outstanding warrants to purchase the
Company's
common stock, in exchange for warrants to purchase 584,885 shares
of Great
Expectations; and (iii) all of the issued and outstanding options
to
purchase the Company's common stock in exchange for an aggregate
of
2,381,525 options to purchase common stock of Great Expectations,
constituting approximately 96% of the common stock of Great Expectations
prior to the issuance of shares of common stock of Great Expectations
in
the private placement described below. Prior to the closing of
the
Recapitalization, Great Expectations performed a 200-for-1 reverse
stock
split, thus reducing the issued and outstanding shares of common
stock of
Great Expectations from 150,520,000 shares to 752,600 shares.
Additionally, 752,600 shares of common stock of Great Expectations
were
issued to the financial advisor in connection with the Recapitalization.
Pursuant to the Recapitalization, there were 17,102,923 common
shares
outstanding in Great Expectations.
As
a result of the transaction, the former shareholders of Advaxis
are the
controlling shareholders of the Company. Additionally, prior to
the
transaction, Great Expectations had no substantial assets. Accordingly,
the transaction is treated as a recapitalization, rather than a
business
combination. The historical financial statements of Advaxis are
now the
historical financial statements of the Company. Historical shareholders'
equity (deficiency) of Advaxis has been restated to reflect the
recapitalization, and include the shares received in the
transaction.
November
12, 2004, the Company completed an initial closing of a private
placement
offering (the “Private Placement”), whereby it sold an aggregate of $2.925
million worth
of units to accredited investors. Each unit was sold for $25,000
(the
“Unit Price”) and consisted of (a) 87,108 shares of common stock and (b) a
warrant to purchase, at any time prior to the fifth anniversary
following
the date of issuance of the warrant, to purchase 87,108 shares
of common
stock included at a price equal to $0.40 per share of common stock
(a
“Unit”). In consideration of the investment, the Company granted to each
investor certain registration rights and anti-dilution rights.
Also, in
November 2004, the Company converted approximately $618,000 of
aggregate
principal promissory notes and accrued interest outstanding into
Units.
On
December 8, 2004, the Company completed a second closing of the
Private
Placement, whereby it sold an aggregate of $200,000 of Units to
accredited
investors.
On
January 4, 2005, the Company completed a third and final closing
of the
Private Placement, whereby it sold an aggregate of $128,000 of
Units to
accredited investors.
|
|
Pursuant
to the terms of a investment banking agreement, dated March
19, 2004, by
and between the Company and Sunrise Securities, Corp. (the
“Placement
Agent”), the Company issued to the Placement Agent and its designees
an
aggregate of 2,283,445 shares of common stock and warrants
to purchase up
to an aggregate of 2,666,900 shares of common stock. The shares
were
issued as part consideration for the services of the Placement
Agent, as
placement agent for the Company in the Private Placement. In
addition, the
Company paid the Placement Agent a total cash fee of $50,530.
On
January 12, 2005, the Company completed a second private placement
offering whereby it sold an aggregate of $1,100,000 of units
to a single
investor. As with the Private Placement, each unit issued and
sold in this
subsequent private placement was sold at $25,000 per unit and
is comprised
of (i) 87,108 shares of common stock, and (ii) a five-year
warrant to
purchase 87,108 shares of our common stock at an exercise price
of $0.40
per share. Upon the closing of this second private placement
offering the
Company issued to the investor 3,832,753 shares of common stock
and
warrants to purchase up to an aggregate of 3,832,753 shares
of common
stock.
The
aggregate sale from the four private placements was $4,353,000,
which was
netted against transaction costs of $329,673 for net proceeds
of
$4,023,327.
|