Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
84-1521955
(I.R.S.
Employer Identification No.)
|
Technology
Centre of New Jersey
675
US Highway One, Suite B113
North
Brunswick, New Jersey
|
08902
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code:
|
(732)
545-1590
|
Securities
registered pursuant to Section 12(b) of the Act:
|
Common
Stock - $.001 par value
The
Common Stock is listed on the Over-The-Counter Bulletin Board
(OTC:BB)
|
Securities
registered pursuant to Section 12(g) of the Act:
|
[None]
|
PART
I
|
||||
|
|
|
|
PAGE
|
Item
1.
|
Description
of Business
|
5
|
||
Item
2.
|
Description
of Properties
|
34
|
||
Item
3.
|
Legal
Proceedings
|
34
|
||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
34
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||
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||||
PART
II
|
||||
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||||
Item
5.
|
Market
for the Registrant’s Common Equity and Related Stockholder
Matters
|
35
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||
Item
6.
|
Management’s
Discussion and Analysis of Financial
|
35
|
||
Item
7.
|
Financial
Statements and Supplementary Data
|
45
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||
Item
8.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
67
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||
Item
8A.
|
Controls
and Procedures
|
67
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||
Item
8B
|
Other
Information
|
67
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||
PART
III
|
||||
Item
9.
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Directors,
Executive Officers, Promoters and Control Persons; Compliance
With
Section 16(a) of the Exchange Act.
|
68
|
||
Item
10.
|
Executive
Compensation
|
72
|
||
Item
11.
|
Security
Ownership of Certain Beneficial Owners and
Management and Related Stockholder
Matters
|
76
|
||
Item
12.
|
Certain
Relationships and Related Transactions
|
77
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||
Item
13.
|
Exhibits
|
78
|
||
Item
14.
|
Principal
Accountant Fees and Services.
|
83
|
Product
|
Indication
|
Stage
|
|||
Lovaxin
C
|
|
Cervical,
Head and Neck
|
|
Phase
I/II; Phase I anticipated to be complete in the fiscal second /third
quarter 2007. Phase II study in cervical cancer anticipated to commence
in
late 2007
|
|
|
|
|
|
|
|
Lovaxin
B
|
|
Breast
cancer
|
|
Preclinical;
Phase I study anticipated to commence in late fiscal 2007/early
2008
|
|
|
|
|
|
|
|
Lovaxin
P
|
|
Prostate
cancer
|
|
Preclinical;
Phase I study anticipated to commence in late fiscal 2008
|
|
|
|
|
|
|
|
Lovaxin
T
|
|
Cancer
through control of telomerase
|
|
Preclinical
|
|
· |
Complete
our Phase I clinical study of Lovaxin C to document the practicability
of
using this agent safely in the therapeutic treatment of cervical
cancer;
|
· | Initiate our Phase II clinical study of Lovaxin C in the therapeutic treatment of cancers. |
· | Initiate a Phase I/II clinical study of Lovaxin B in the therapeutic treatment of breast cancer. |
· | Initiate a Phase I/II clinical study of Lovaxin P in the therapeutic treatment of prostate cancer. |
· | 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. |
1.
|
Innate
immunity: the non-specific stimulation of all aspects of the immune
system
in response to a bacterial infection
|
2.
|
Exogenous
pathway: the stimulation of helper T cell function that stimulates
and
supports cytotoxic T cell function.
|
3.
|
Endogenous
pathway: the direct stimulation of cytotoxic T cells in an amplified
fashion due accelerated antigen fragment generation
|
4.
|
Lack
of Tregs: the stimulation of the facilitory aspects of an anti-tumoral
immune response without the inhibitory aspects as a result of the
LLO
antigen fusion protein
|
5.
|
Supportive
local tumor environment: the adjuvant stimulation of various chemical
factors within the tumor that support the anti-tumor effect of
the immune
system stimulated by the effective delivery of the specific
antigen.
|
Product
|
Indication
|
Stage
|
||
|
|
|
|
|
Lovaxin
C
|
|
Cervical,
Head and Neck
|
|
Phase
I/II; Phase I anticipated to be complete in the fiscal second /third
quarter 2007
Phase
II study in cervical cancer anticipated to commence in late fiscal
2007
|
Lovaxin
B
|
|
Breast
cancer
|
|
Preclinical;
Phase I study anticipated to commence in late fiscal 2007/early
2008
|
Lovaxin
P
|
|
Prostate
cancer
|
|
Preclinical;
Phase I study in late fiscal 2008
|
Lovaxin
T
|
|
Cancer
through control of telomerase
|
|
Preclinical
|
|
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 November 8,
2014.
|
|
|
|
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, Attenuated 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, Frankel et al. Divisional
Application No. 09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL
And DAT Genes”. Filed March 7, 2000, Expires November 18,
2017.
|
|
|
|
U.S.
Patent No. 6,635,749, issued October 21, 2003, Frankel, et
al. Divisional U.S. Patent Application No. 10/136,253 for “Isolated
Nucleic Acids Comprising Listeria DAL and DAT Genes.” Filed May 1,
2002, Filed May 1, 2022. Expires November 18,
2017.
|
|
|
U.S.
Patent No. 5,830,702, issued November 3, 1998, Portnoy, et al. Patent
Application No. 08/366,477, filed December 30, 1994 for “Live, Recombinant
Listeria SSP Vaccines and Productions of Cytotoxic T Cell Response” 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.
|
|
US
Patent No. 6,855,320 issued February 15, 2005, Paterson. Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysin o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Expires March 29, 2020.
|
|
US
Patent No. 7,135,188 issued November 14, 2006, Paterson, Patent
Application No. 10/441,851 for “Methods and compositions for immunotherapy
of cancer.” Filed May 20, 2003. Expires November 8,
2014.
|
|
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, 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.
|
U.S. Patent Application No. 10/835,662, “Compositions and methods for enhancing the immunogenicity of antigens,” Filed April 30, 2004, Paterson et al. | |
U.S.
Patent Application No. 10/949,667, “Methods and compositions for
immunotherapy of cancer,” Filed September 24, 2004, Paterson et
al.
|
|
U.S.
Patent Application No. 11/223,945, “Listeria-based and LLO-based
vaccines,” Filed September 13, 2005, Paterson et al.
|
|
U.S.
Patent Application No. 11/376,564, “Compositions and methods for enhancing
the immunogenicity of antigens,” Filed March 16, 2006, Paterson et
al.
|
|
U.S.
Patent Application No. 11/376,572, “Compositions and methods for enhancing
the immunogenicity of antigens,” Filed March 16, 2006, Paterson et
al.
|
|
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.
|
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.
|
|
|
|
|
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. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. 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.
|
PCT
International Patent Application No. PCT/US06/44681 for “Methods For
Producing, Growing, And Preserving Listeria
Vaccine Vectors.” Filed November 16, 2006, Rothman, et
al.
|
|
· who
must be recruited as qualified participants;
|
· how
often to administer the drug;
|
· what
tests to perform on the participants;
and
|
· |
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 will significantly 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 preclinical 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;
|
· |
Market
conditions. For example when we raise our next round of financing
the
market conditions may not provide adequate
funding.
|
· |
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.
|
· |
Preclinical
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 preclinical
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 quoted on the Nasdaq Small Cap Market,
American Stock Exchange or other national market
system;
|
· |
changes
in accounting principles; and
|
· |
discussion
of the company or our stock price by the financial and scientific
press
and in online investor communities.
|
· |
The
impact of the embedded conversion feature in the secured convertible
debenture.
|
· |
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.
|
|
Votes
For
|
Votes
Against
|
|||||
Election
of Directors:
|
|
|
|||||
J.
Todd Derbin
|
28,450,225
|
233,990
|
|||||
Roni
Appel
|
28,629,515
|
54,700
|
|||||
James
Patton
|
28,629,515
|
54,700
|
|||||
Thomas
McKearn
|
28,629,515
|
54,700
|
|||||
Martin
Wade
|
28,629,515
|
54,700
|
|||||
Richard
Berman
|
28,629,515
|
54,700
|
|
Votes
For
|
Votes
Against
|
Abstentions
|
Broker
Non-votes
|
|||||||||
Approved
and adopted the 2005 Stock Option Plan
|
18,543,773
|
66,200
|
6,374,683
|
|
|||||||||
Approved
the reincorporation of the Company from the state of Colorado to
the state
of Delaware
|
24,966,456
|
6,200
|
7,000
|
|
|||||||||
Ratified
the appointment by the Board of Directors of Goldstein Golub Kessler
LLP
as auditor of the Company’s financial statements for the year ending
October 31, 2006
|
22,320,326
|
1,200
|
6,362,688
|
|
Fiscal
2006
|
Fiscal
2005
|
||||||
High
|
Low
|
High
|
Low
|
||||
First
Quarter November 1-January 31
|
$0.27
|
$0.16
|
N/A
|
N/A
|
|||
Second
Quarter February 1- April 30………………………
|
$0.37
|
$0.21
|
N/A
|
N/A
|
|||
Third
Quarter…May 1 -July 31……………………
|
$0.30
|
$0.17
|
$1.25
|
$0.35
|
|||
Fourth
Quarter August 1, - October 31………………………………
|
$0.25
|
$0.13
|
$0.52
|
$0.15
|
· |
Complete
Phase I clinical study of Lovaxin C;
|
· |
Initiate
a Phase II clinical study of Lovaxin C Cervical
Cancer
|
· |
Initiate
Preclinical Studies and a Phase I study of Lovaxin B Breast
Cancer
|
· |
Initiate
Preclinical Studies and a Phase I study of Lovaxin P Prostate
Cancer
|
· |
Continue
preclinical development of Lovaxin T
|
· |
Continue
research to expand our technology
platform.
|
· |
Cost
incurred to date: approximately
$1,000,000
|
· |
Estimated
future costs: $500,000 Phase I and $2,500,000 - $4,000,000 Phase
II
|
· |
Anticipated
completion date: second/third quarter fiscal 2007 Phase I and Phase
II
2008 and beyond.
|
· |
Uncertainties:
|
- |
the
FDA (or relevant foreign regulatory authority) may not approve the
study
|
- |
One
or more serious adverse events in patients enrolled in the
trial
|
- |
difficulty
in recruiting patients
|
- |
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 to date: $300,000
|
· |
Estimated
future costs: $1,800,000
|
· |
Anticipate
completion dates: fourth quarter of fiscal 2008 or
beyond
|
· |
Risks
and uncertainties:
|
- |
Obtaining
favorable animal data
|
- |
Proving
low toxicity in animals
|
- |
Manufacturing
scale up to GMP level
|
- |
FDA
(or foreign regulatory authority) may not approve the
study
|
- |
The
occurrence of a severe or life threatening adverse event in a
patient
|
- |
Delays
in the program
|
- |
Commencement
of material cash flows:
|
- |
Unknown
at this stage, dependent upon a licensing deal or to a marketing
collaboration subject to regulatory approval to market and sell the
product.
|
· |
Cost
incurred to date: $100,000
|
· |
Estimated
future costs: $1,500,000
|
· |
Anticipate
completion dates: fourth quarter of fiscal 2008 or
beyond
|
· |
Risks
and uncertainties: See Lovaxin in B
(above)
|
· |
Clinical
trial expenses increased $328,389, or 351%, from $93,525 to $421,915
due
to the start-up of our clinical trial in March
2006.
|
· |
Wages,
salaries and related lab costs increased by $409,524, or 215%, from
$190,804 to $600,329 principally due to our expanded research and
development staffing in early 2006.
|
· |
Subcontracted
expenses increased by $107,949, or 76.3%, from $141,366 to $249,315
reflecting the additional subcontract work performed by Dr. Paterson
at
Penn, pursuant to certain grants.
|
· |
Manufacturing
expenses decreased $383,387, or 93.6%, from $409,542 to $26,155;
the
result of the fiscal 2005 manufacturing program in anticipation of
the
Lovaxin C for toxicology and clinical trials required in early
2006.
|
· |
Toxicology
study expenses decreased $259,548, or 88.6%, from $293,105 to $33,558;
principally as a result of the initiation in the earlier period of
toxicology studies by Pharm Olam in connection with our Lovaxin C
product
candidates in anticipation of the clinical studies in
2006.
|
· |
Consulting
fees and related expenses increased by $580,197, or 190%, from $305,153
for the twelve months ended October 31, 2005 to $885,349 for the
same
period in 2006 arising from a higher bonus expense, stock expense,
consulting fees and the fair value of options primarily for the Chief
Executive Officer(s) and consultants.
|
· |
An
increase in legal fees and public relations expenses of $391,611,
or 364%,
from $107,370 for the twelve-months ended October 31, 2005 to $498,611
for
the same period in 2006, primarily as a result of an increase in
the costs
arising from being publicly held.
|
· |
A
decrease in offering and analyst expenses of $132,498 incurred in
fiscal
2005 while none were incurred in
2006.
|
· |
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 in
2005 of
Lovaxin C in for toxicology and clinical
trials;
|
· |
Expenses
in fiscal 2005 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
twelve months ended October 31, 2004 to $341,639 for the twelve months
ended October 31, 2005 arising from a bonus to Mr. Derbin, the Chief
Executive Officer, in stock, an increase in the salary of Mr. Derbin,
and
the cost of health insurance initiated in 2005;
|
· |
offering
expenses increased by $117,498, or 100%, from $0 for the twelve months
ended October 31, 2004 to $117,498 for the twelve months ended October
31,
2005 arising from legal and banking expenses relating to the private
placement closed in November 2004;
|
· |
an
increase in professional fees from $231,686 for the twelve-months
ended
October 31, 2004 to $460,691 for the twelve months ended October
31, 2005,
primarily as a result of an increase in legal fees, public relations
fees,
consulting fees and accounting fees.
|
Advaxis,
Inc.
|
Page
|
Report
of Independent Registered Public Accounting Firm
|
46
|
Balance
Sheet as of October 31, 2006
|
47
|
Statements
of Operations for the years ended October 31, 2005 and 2006 and
the period
from
|
|
March
1, 2002 (Inception) to October 31, 2006
|
48
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to
|
|
October
31, 2006
|
49
|
Statements
of Cash Flows for the years ended October 31, 2005 and 2006 and
the period
from
|
|
March
1, 2002 (Inception) to October 31, 2006
|
52
|
Notes
to the Financial Statements
|
54
|
|
October
31, 2006
|
||||
ASSETS
|
|
|||
Current
Assets:
|
||||
Cash
|
$
|
2,761,166
|
||
Prepaid
expenses
|
38,100
|
|||
Total
Current Assets
|
2,799,266
|
|||
Property
and Equipment (net of accumulated depreciation of $24,441)
|
64,742
|
|||
Intangible
Assets (net of accumulated amortization of $94,555)
|
956,409
|
|||
Deferred
Financing Costs (net of accumulated amortization of
$82,313)
|
177,687
|
|||
Other
Assets
|
4,600
|
|||
TOTAL
ASSETS
|
$
|
4,002,704
|
||
|
|
|||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
|
|||
Current
Liabilities:
|
|
|||
Accounts
payable
|
$
|
810,221
|
||
Accrued
expenses
|
522,467
|
|||
Deferred
revenue
|
20,350
|
|||
Notes
payable - current portion
|
191,577
|
|||
Total
Current Liabilities
|
1,544,615
|
|||
|
||||
Interest
payable
|
119,934
|
|||
Notes
payable - net of current portion
|
313,000
|
|||
Convertible
Secured Debentures and fair value of embedded derivative
|
5,017,696
|
|||
Common
Stock Warrants
|
714,600
|
|||
Total
Liabilities
|
$
|
7,709,845
|
||
|
||||
Shareholders’
Deficiency:
|
||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 40,238,992
|
40,239
|
|||
Additional
Paid-In Capital
|
5,914,793
|
|||
Deficit
accumulated during the development stage
|
(9,662,173
|
)
|
||
Total
Shareholders' Deficiency
|
(3,707,141
|
)
|
||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$
|
4,002,704
|
Year
Ended
October
31,
|
Year
Ended
October
31,
|
Period
from
March
1, 2002 (Inception) to
October
31,
|
||||||||
2005
|
2006
|
2006
|
||||||||
Revenue
|
$
|
552,868
|
$
|
431,961
|
$
|
1,105,235
|
||||
Research
& Development Expenses
|
1,175,536
|
1,404,164
|
3,248,048
|
|||||||
General
& Administrative Expenses
|
1,219,792
|
2,077,062
|
4,343,793
|
|||||||
Total
Operating expenses
|
2,395,328
|
3,481,226
|
7,591,841
|
|||||||
Loss
from Operations
|
(1,842,460
|
)
|
(3,049,265
|
)
|
(6,486,606
|
)
|
||||
Other
Income (expense):
|
||||||||||
Interest
expense
|
(7,307
|
)
|
(437,299
|
)
|
(466,027
|
)
|
||||
Other
Income
|
43,978
|
90,899
|
136,422
|
|||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
-
|
(2,802,078
|
)
|
(2,802,078
|
)
|
|||||
Net
loss
|
(1,805,789
|
)
|
(6,197,744
|
)
|
(9,618,289
|
)
|
||||
Dividends
attributable to preferred shares
|
43,884
|
|||||||||
Net
loss applicable to Common Stock
|
$
|
(1,805,789
|
)
|
$
|
(6,197,744
|
)
|
$
|
(9,662,173
|
)
|
|
Net
loss per share, basic and diluted
|
$
|
(0.05
|
)
|
$
|
(0.16
|
)
|
||||
Weighted
average number of shares outstanding basic and diluted
|
35,783,666
|
38,646,769
|
Preferred
Stock
|
Common
Stock
|
|||||||||||||||||||||
Number
of Shares Outstanding
|
Amount
|
Number
of shares outstanding
|
Amount
|
Additional
Paid-in
Capital
|
Deficit
Accumulated During the Development Stage
|
Shareholders'
Equity (Deficiency)
|
||||||||||||||||
Preferred
stock issued
|
|
|||||||||||||||||||||
3,418
|
$
|
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 re-capitalization on November 12,
2004
|
||||||||||||||||||||||
(3,481
|
)
|
(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
|
15,969
|
15,969
|
||||||||||||||||||||
Options
granted to consultants and professionals
|
||||||||||||||||||||||
8,484
|
8,484
|
|||||||||||||||||||||
Net
loss
|
(909,745
|
)
|
(909,745
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on November 12,
2004
|
||||||||||||||||||||||
(232
|
)
|
(15,969
|
)
|
15,969
|
||||||||||||||||||
Balance
at December 31, 2003
|
||||||||||||||||||||||
15,597,723
|
$
|
15,598
|
$
|
254,348
|
$
|
(1,076,681
|
)
|
$
|
(806,735
|
)
|
Stock
dividend on preferred stock
|
||||||||||||||||||||||
638
|
43,884
|
(43,884
|
)
|
|||||||||||||||||||
Net
loss
|
(538,076
|
)
|
(538,076
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
||||||||||||||||||||||
5,315
|
5,315
|
|||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on November 12,
2004
|
||||||||||||||||||||||
(638
|
)
|
(43,884
|
)
|
43,884
|
||||||||||||||||||
Balance
at October 31, 2004
|
||||||||||||||||||||||
15,597,723
|
$
|
15,598
|
$
|
303,547
|
$
|
(1,658,641
|
)
|
$
|
(1,339,496
|
)
|
Common
Stock issued to Placement Agent on
re-capitalization
|
||||||||||||||||||||||
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Effect
of re-capitalization
|
||||||||||||||||||||||
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 re- capitalization on November 12, 2004 including cash
paid of
$44,940
|
(88,824
|
)
|
(88,824
|
)
|
||||||||||||||||||
Balance
at October 31, 2005
|
37,686,428
|
$
|
37,686
|
$
|
5,178,319
|
$
|
(3,464,430
|
)
|
$
|
1,751,575
|
Options
granted to consultants and professionals
|
172,831
|
172,831
|
||||||||||||||||||||
Options
granted to employees and directors
|
71,667
|
71,667
|
||||||||||||||||||||
Conversion
of debenture to Common Stock
|
1,766,902
|
1,767
|
298,233
|
300,000
|
||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
229,422
|
229
|
54,629
|
54,858
|
||||||||||||||||||
Issuance
of common stock to consultants
|
556,240
|
557
|
139,114
|
139,674
|
||||||||||||||||||
Net
loss
|
(6,197,744
|
)
|
(6,197,744
|
)
|
||||||||||||||||||
Balance
at October 31, 2006
|
40,238,992
|
$
|
40,239
|
$
|
5,914,793
|
$
|
(9,662,173
|
)
|
$
|
(3,707,141
|
)
|
|
|
|
|
|
Period
from
|
|
||||
|
|
|
|
|
|
March
1
|
|
|||
|
|
|
|
|
|
2002
|
|
|||
|
|
Year
ended
|
|
Year
ended
|
|
(Inception)
to
|
|
|||
|
|
October
31,
|
|
October
31,
|
|
October
31,
|
|
|||
|
|
2005
|
|
2006
|
|
2006
|
|
|||
OPERATING
ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(1,805,789
|
)
|
$
|
(6,197,744
|
)
|
$
|
(9,618,289
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
net cash used in operating activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
231,701
|
439,027
|
711,210
|
|||||||
Amortization
of deferred financing costs
|
82,313
|
82,313
|
||||||||
Non-cash
interest expense
|
230,218
|
230,218
|
||||||||
Accrued
interest on notes payable
|
12,308
|
123,934
|
136,242
|
|||||||
Loss
on change in value of warrants and embedded derivative
|
2,802,078
|
2,802,078
|
||||||||
Value
of penalty shares issued
|
117,498
|
117,498
|
||||||||
Depreciation
expense
|
7,432
|
17,009
|
24,441
|
|||||||
Amortization
expense of intangibles
|
33,669
|
45,068
|
97,726
|
|||||||
Increase
in prepaid expenses
|
(38,100
|
)
|
(38,100
|
)
|
||||||
Increase
in other assets
|
(4,600
|
)
|
(4,600
|
)
|
||||||
Increase
(decrease) in accounts payable
|
(132,149
|
)
|
158,335
|
1,125,427
|
||||||
Increase
in accrued expenses
|
-
|
522,467
|
506,278
|
|||||||
Deferred
Revenue
|
-
|
20,350
|
20,350
|
|||||||
Net
cash used in operating activities
|
(1,539,930
|
)
|
(1,795,045
|
)
|
(3,807,208
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
(44,940
|
)
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(80,577
|
)
|
(8,606
|
)
|
(89,183
|
)
|
||||
Cost
of intangible assets
|
(314,953
|
)
|
(250,389
|
)
|
(967,054
|
)
|
||||
Net
cash used in Investing Activities
|
(440,470
|
)
|
(258,995
|
)
|
(1,101,177
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from convertible secured debenture
|
3,000,000
|
3,000,000
|
||||||||
Cash
paid for deferred financing costs
|
(260,000
|
)
|
(260,000
|
)
|
||||||
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
|
2,740,000
|
7,669,551
|
|||||||
Net
increase in cash
|
2,042,927
|
685,960
|
2,761,166
|
|||||||
Cash
at beginning of period
|
32,279
|
2,075,206
|
||||||||
Cash
at end of period
|
$
|
2,075,206
|
$
|
2,761,166
|
$
|
2,761,166
|
Supplemental
Schedule of Noncash Investing and Financing Activities
|
||||||||||
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
Period
from
|
|
|
|
|
Year
ended
|
|
|
Year
ended
|
|
|
March
1, 2002
|
|
|
|
|
October 31,
|
|
|
October
31,
|
|
|
(Inception)
to
|
|
|
|
|
2005
|
|
|
2006
|
|
|
October
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
|
$
|
300,000
|
$
|
913,158
|
||||
Intangible
assets acquired with notes payable
|
$
|
360,000
|
||||||||
Debt
discount in connection with recording the original value of the
embedded derivative liability
|
$
|
$
|
512,865
|
$
|
512,865
|
|||||
Allocation
of the original secured convertible debentures to
warrants
|
$
|
$
|
214,950
|
$
|
214,950
|
1. | PRINCIPAL BUSINESS ACTIVITY AND |
SUMMARY OF SIGNIFICANT | |
ACCOUNTING POLICIES: |
October
31, 2006
|
||||
Warrants
|
25,009,220
|
|||
Stock
Options
|
6,959,077
|
|||
Convertible
Debt (1)
|
14,210,526
|
|||
Total
All
|
46,178,823
|
|
Year
ended October 31, 2005
|
March
1, 2002
(date
of inception)
to
October
31, 2006
|
|||||
|
|
||||||
Net
Loss as reported
|
$
|
(1,805,789
|
)
|
$
|
(9,618,289
|
)
|
|
Add:
Stock based option expense included in recorded net loss
|
64,924
|
89,217
|
|||||
Deduct
stock option compensation expense determined under fair value based
method
|
(200,942
|
)
|
(328,176
|
)
|
|||
Adjusted
Net Loss
|
$
|
(1,941,807
|
)
|
$
|
(9,379,330
|
)
|
|
Basic
and Diluted Net Loss per share as reported
|
$
|
(0.05
|
)
|
||||
Basic
and Diluted Net Loss per share pro forma
|
$
|
(0.05
|
)
|
|
Year
Ended
|
Year
Ended
|
|
|
October
31, 2005
|
October
31, 2006
|
|
Expected
volatility
|
30%
|
127.37%
|
|
Expected
Life
|
10
years
|
7.7
years
|
|
Dividend
yield
|
0
|
0
|
|
Risk-free
interest rate
|
4.5%-5.25%
|
4.6%
|
Trademarks
|
$
|
74,948
|
||
Patents
|
490,893
|
|||
License
|
485,123
|
|||
Less:
Accumulated Amortization
|
(94,555
|
)
|
||
|
||||
$
|
956,409
|
Year
ending October 31,
|
|
|||
2007
|
$
|
52,548
|
||
2008
|
52,548
|
|||
2009
|
52,548
|
|||
2010
|
52,548
|
|||
2011
|
52,548
|
Salaries
and other compensation
|
$
|
275,478
|
||
Consulting
|
185,683
|
|||
Other
(less than 5%)
|
61,306
|
|||
$
|
522,467
|
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 agreement
|
$
|
61,577
|
||
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
|
|||
Total
|
504,577
|
|||
Less
current portion
|
191,577
|
|||
|
$
|
313,000
|
Aggregate
maturities of notes payable at October 31, 2006 are as follows:
|
|
|||
Year
ending October 31,
|
|
|||
2007
|
191,577
|
|||
2008
|
313,000
|
|||
Total
|
$
|
504,577
|
Convertible
Secured Debentures due February 1, 2009: 6% per annum
|
$
|
3,000,000
|
||
Common
Stock Warrant liability
|
$ |
(214,950
|
)
|
|
Embedded
derivative liability
|
$ |
(512,865
|
)
|
|
Convertible
Debenture as the date of sale
|
$
|
2,272,185
|
||
Amortization
of discount on warrants & embedded feature as of October 31,
2006
|
$
|
230,218
|
||
Conversion
of Cornell Capital Partners LP
|
$ |
(300,000
|
)
|
|
Convertible
Secured Debenture Liability as of October 31, 2006
|
$
|
2,202,403
|
||
Embedded
Derivative Liability
|
2,815,293
|
|||
Convertible
Secured Debentures and Fair Value of Embedded Derivative
Liability
|
$
|
5,017,696
|
Date
of
Conversion
|
Amount
of
Conversion
|
Number
of
Shares
|
Conversion
Share
Price
|
|||
April
20, 2006
|
$50,000
|
212,947
|
.2348
|
|||
May
9, 2006
|
$50,000
|
212,947
|
.2348
|
|||
July
6, 2006
|
$25,000
|
112,918
|
.2214
|
|||
July
19, 2006
|
$25,000
|
139,198
|
.1796
|
|||
August
2, 2006
|
$25,000
|
160,051
|
.1562
|
|||
August
10, 2006
|
$25,000
|
183,959
|
.1359
|
|||
September
14, 2006
|
$25,000
|
186,567
|
.1340
|
|||
September
26, 2006
|
$25,000
|
186,567
|
.1340
|
|||
October
9, 2006
|
$25,000
|
185,874
|
.1345
|
|||
October
20, 2006
|
$25,000
|
185,874
|
.1345
|
|||
Total
|
$300,000
|
1,766,902
|
Date
of
Conversion
|
Amount
of
Conversion
|
Number
of
Shares
|
Conversion
Share
Price
|
|||
November
7, 2006
|
$25,000
|
177,305
|
$.1410
|
|||
November
17, 2006
|
$25,000
|
169,377
|
$.1476
|
|||
December
1, 2006
|
$25,000
|
160,979
|
$.1553
|
|||
December
18, 2006
|
$50,000
|
367,377
|
$.1361
|
|||
January
19, 2007
|
$25,000
|
183,688
|
$.1361
|
|||
February
1, 2007
|
$25,000
|
166,445
|
$.1502
|
|||
Total
|
$175,000
|
1,225,171
|
Shares
|
Weighted
Average Exercise Price
|
Remaining
Life
In Years
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
as of October 31, 2004
|
2,389,271
|
$
|
0.23
|
8.4
|
|||||||||
Granted
|
3,242,547
|
$
|
0.29
|
||||||||||
Cancelled
or Expired
|
789,279
|
$
|
0.23
|
||||||||||
Exercised
|
-
|
-
|
|||||||||||
Outstanding
as of October 31, 2005
|
4,842,539
|
$
|
0.27
|
8.1
|
6,867
|
||||||||
Granted
|
2,233,179
|
$
|
0.22
|
|
12,000
|
||||||||
Cancelled
or Expired
|
(116,641
|
)
|
$
|
0.37
|
|
|
|||||||
Exercised
|
—
|
—
|
|
|
|||||||||
Outstanding
as of October 31, 2006
|
6,959,077
|
$
|
0.25
|
7.7
|
$
|
18,867
|
|||||||
Vested
& Exercisable at October 31, 2006
|
3,755,910
|
$
|
0.25
|
7.3
|
$
|
6,867
|
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||||||
Range
of
Exercise
Prices
|
Number
Outstanding
|
Weighted-
Average
Remaining
Contractual
Life (in Years)
|
Weighted-
Average
Exercise
Price
per
Share
|
Aggregate
Intrinsic
Value
|
Number
Exercisable
|
Weighted-
Average
Exercise
Price
per
Share
|
Aggregate
Intrinsic
Value
|
||||||||||||||||
$
0.16-0.18
|
300
|
9.9
|
$
|
0.16
|
$
|
12,000
|
0
|
$
|
0.16
|
0
|
|||||||||||||
0.19-0.21
|
2,607
|
6.7
|
0.20
|
6,867
|
1,899
|
0.20
|
$
|
6,867
|
|||||||||||||||
0.24-0.26
|
760
|
9.4
|
0.26
|
0
|
50
|
0.26
|
0
|
||||||||||||||||
0.28-0.29
|
|
2,970
|
8.3
|
0.29
|
0
|
1,485
|
0.29
|
0
|
|||||||||||||||
0.35-0.43
|
322
|
6.3
|
0.37
|
322
|
0.37
|
||||||||||||||||||
|
|
|
|||||||||||||||||||||
Total
|
6,959
|
7.7
|
$
|
0.25
|
$
|
18,867
|
3,756
|
$
|
0.25
|
$
|
6,867
|
Number
of Shares
|
Weighted
Average Exercise Price 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
|
2,233,179
|
$
|
0.22
|
9.4
|
||||||
Options
vested
|
(1,416,554
|
)
|
$
|
0.25
|
7.8
|
|||||
Options
forfeited or expired
|
-
|
-
|
-
|
|||||||
Non-vested
shares at October 31, 2006
|
3,203,167
|
$
|
0.25
|
9.0
|
Net
operating losses
|
$
|
2,090,711
|
||
Stock
based compensation
|
182,086
|
|||
Less
valuation allowance
|
(2,272,797
|
)
|
||
Deferred
tax asset
|
$
|
-0-
|
Year
ended
October
31, 2005
|
Year
ended
October
31, 2006
|
Period
from
March
1, 2002
(inception)
to
October
31, 2006
|
||||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
||||
|
-0-
|
%
|
-0-
|
%
|
-0-
|
%
|
Name
|
Age
|
Position
|
||
|
|
|
||
Thomas
Moore (3)
|
55
|
Chief
Executive Officer and Chairman of the Board of
Directors
|
||
|
|
|
||
Dr.
James Patton (1)
|
48
|
Director
|
||
|
|
|
||
Roni
A. Appel (3) (4) (5)
|
39
|
Director
|
||
|
|
|
||
Dr.
Thomas McKearn (2)
|
56
|
Director
|
||
|
|
|
||
Richard
Berman (1) (2) (4)
|
63
|
Director
|
||
Martin
R. Wade III
|
56
|
Director
|
||
Dr.
John Rothman
|
58
|
Vice
President, Clinical Development
|
||
Fred
Cobb
|
59
|
Vice
President, Finance and Principal Financial
Officer
|
(1)
|
Member
of the Audit Committee.
|
||||
(2)
|
Member
of the Compensation Committee.
|
||||
(3)
|
Member
of the Nominating and Corporate Governance Committee.
|
||||
(4)
|
Member
of the Finance Committee
|
||||
(5)
|
Mr.
Appel resigned as President, Chief Executive Officer on December
15, 2006
|
·
|
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
including review of possible conflicts and transactions with persons
affiliated with Directors or members of management; 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
|
Salary($)
|
Bonus
($)
|
|
Other**
|
|
Securities
Underlying
Options
|
|||||||||||||||||||||
Thomas
Moore*
|
2006
|
|||||||||||||||||||||||||||
Roni Appel(1)
|
2006
|
$ | 243,042 |
(2)
|
$ | 320,000 |
(4)
|
$ | 53,774 |
(5)
|
1,173,179 |
(2)
|
||||||||||||||||
President, CEO, Secretary, Chief Financial Officer, |
2005
|
$ | 139,250 |
(2)
|
$
|
35,000
|
(3)
|
1,114,344 |
(2)
|
|||||||||||||||||||
and
Director
|
2004
|
$
|
50,000
|
(3)
|
|
|
|
|
|
|
|
|
|
35,218
|
|
|
||||||||||||
J. Todd Derbin(6) |
2006
|
$ | 73,200 | $ | 3,850 |
(7)
|
$
|
4,043
|
(8)
|
|||||||||||||||||||
President,
Chief Executive Officer, and Director
|
|
|
2005
|
|
$
|
225,000 | $ | 45,000 |
(7)
|
684,473 |
(9)
|
|||||||||||||||||
|
2004
|
$
|
125,000
|
$
|
60,000
|
(7)
|
|
|
|
|
|
--
|
|
|
||||||||||||||
Dr.
John Rothman
|
2006
|
$
|
201,538
|
(10)
|
|
$
|
10,000
|
|
$
|
23,320
|
(8)(17)
|
|
150,000
|
(11)
|
|
|||||||||||||
Vice President, Clinical |
2005
|
$
|
141,667
|
(13)
|
|
-- |
360,000
|
(12)
|
||||||||||||||||||||
Development
|
--
|
|||||||||||||||||||||||||||
Fred
Cobb
|
2006
|
$
|
93,195
|
(14)
|
|
--
|
|
--
|
|
300,000
|
(15)
|
|
||||||||||||||||
Vice
President Finance
|
||||||||||||||||||||||||||||
Dr.
Vafa Shahabi
|
|
|
2006
|
|
$
|
111,370 |
(14)
|
-- |
$
|
3,288
|
(17)
|
250,000 |
(18)
|
|||||||||||||||
|
2005
|
$
|
82,190
|
(16)
|
|
--
|
|
|
|
|
150,000
|
(19)
|
|
(1) |
Mr.
Appel served as consultant (LVEP) in the capacity of Secretary and
CFO in
2004 and 2005. He was appointed President and CEO on January 1, 2006.
He
resigned his position of President, CEO and Secretary on December
15, 2006
and resigned from his CFO position on September 7, 2006. Persuant
to the
consulting agreement, dated as of January 19, 2005, and amended on
April
15, 2005, October 31, 2005, and December 15, 2006, LVEP is to provide
various financial and strategic consulting services to
us.
|
(2) |
Mr.
Appel’s compensation in 2005 and 2006 was paid through our consulting
agreement with LVEP. The option awards were the result of grants
of
options at $0.217 per share in fiscal 2006 and 0.287 per share in
fiscal
2005.
|
(3) |
Represents
consulting fees of $50,000 in the ten months ended October 31, 2004
paid
to Carmel Ventures, Inc., of which he is a principal stockholder.
He
assigned $35,000 of such fees to Mr. Scott Flamm.
|
(4) |
Represents
2005 bonus of $70,000 ($20,000 cash and $50,000 in stock) paid in
2006, a
2006 bonus of $250,000 paid in cash January 2, 2007. It does not
include
the 1,000,000 shares of common stock awarded on December 15, 2006
and
issued on January 3, 2007
|
(5)
|
Other:
reimbursements for payroll taxes, healthcare cost, workers compensation,
401K match and employment related cost.
|
(6)
|
Mr.
Derbin resigned as President and CEO on December 31, 2005 and as
a
Director September 7, 2006.
|
(7)
|
Mr. Derbin’s 2003 bonus of $60,000 was paid in 2004 by the issuance of 307,377 shares of common Stock of the Company on the basis of a price of $0.1952 per share and was two-third’s of the maximum amount of $90,000 he could have been awarded. |
In determining Mr. Derbin’s bonus, the Board acted in part on a discretionary basis. His 2004 bonus of 45,000 was paid in 2005 by issuance of 156,794 shares of the company’s Common Stock based on $0.287 per share. His 2005 bonus of $3,850 was paid in 2006 by issuance of 17,422 shares of Company’s Common Stock based on $0.22 per share. |
(8) |
Health
care insurance
|
(9) |
Pursuant
to an employment agreement, only 928,441 of the options granted in
2003
had vested, and only 427,796 of the options granted in 2005 had vested
on
termination of the agreement on December 31, 2005. The balance of
the
options were cancelled.
|
(10) |
Included
in his base compensation is $25,000 payable in
stock.
|
(11) |
Options
granted at $0.26 share
|
(12) |
Options
granted at $0.287 per share.
|
(13) |
Dr.
Rothman entered employment on March 7, 2005 and included in his salary
was
in the issuance of 80,000 shares of common stock or
$14,800.
|
(14) |
Included
in base compensation is $6,667 payable in
stock.
|
(15) |
Includes
150,000 options at $0.26 plus shares as part of employment agreement
and
includes 150,000 options at $0.16 per share granted on September
21,
2006.
|
(16) |
Dr.
Shahabi entered employment on March 1, 2005 and included in her base
is
80,000 shares of common stock or
$14,800.
|
(17) |
Represents
401K match
|
(18) |
Represents
100,000 options granted at $0.24 per share and 150,000 options granted
at
$0.16 per share
|
(19) |
Represents
150,000 options granted at $0.287 per share as part of her employment
agreement
|
Name
|
|
Year
|
|
Number
Of Securities Underlying Options
Granted
|
|
Percent
Of Total Options Granted To Employees In
Fiscal Period
|
|
Exercise
Price
|
|
Expiration
Date
|
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation
For
Option
Term($)
|
||||||||||
5%
|
10%
|
|||||||||||||||||||||
Roni Appel | 2006 | 1,173,179 | (2) | 53 | % | $ | 0.217 | 12/31/2015 | $ | 160,113 | $ | 405,809 | ||||||||||
Secretary and Chief | 2005 | 1,114,344 | (3) | 34 | % | $ | 0.29 | 3/31/2015 | $ | 201,165 | $ | 509,788 | ||||||||||
Executive
Officer
|
2004
|
35,218
|
|
27
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
7,753
|
$
|
19,648
|
||||||||||
J. Todd Derbin(1) | 2006 | - | - | - | - | - | - | |||||||||||||||
President, Chief Executive Officer, | 2005 | 427,796 | (4) |
13
|
%
|
$ | 0.29 | 2/1/2015 | $ | 78,034 | $ | 197,753 | ||||||||||
and
Director
|
2004
|
-
|
|
|
-
|
-
|
-
|
-
|
||||||||||||||
Dr.
John Rothman
|
2006
|
150,000
|
7
|
%
|
$
|
.026
|
3/29/2016
|
$
|
24,528
|
$
|
62,167
|
|||||||||||
Vice
President Clinical
|
2005
|
360,000
|
11
|
%
|
$
|
0.29
|
3/1/2015
|
$
|
64,988
|
$
|
164,692
|
Fred
Cobb
|
2006
|
150,000
|
7
|
%
|
$
|
0.26
|
2/20/2016
|
$
|
19,811
|
$
|
50,212
|
|||||||||||
Vice
President Finance
|
2006 |
150,000
|
7
|
%
|
$
|
0.16
|
9/20/2016
|
$
|
15,094
|
$
|
38,257
|
|||||||||||
Dr. Vafa Shahabi | 2006 | 100,000 | 5 | % | $ | 0.24 | 7/1/2016 | $ | 15,094 | $ | 38,257 | |||||||||||
Director of Research & | 2006 | 150,000 | 7 | % | $ | 0.16 | 9/20/2016 | $ | 15,094 | $ | 38,257 | |||||||||||
Development
|
2005
|
150,000
|
5
|
%
|
$
|
0.29
|
3/1/2015
|
$
|
22,641
|
$
|
57,385
|
(1) |
As
of January 1, 2007, 1,356,237 previously granted and vested but
unexercised options were forfeited.
|
(2) |
Reflects
a grant in January 2006 post fiscal year end increasing the number
of
options to 5% of the outstanding shares and options of the Company
as of
December 31, 2005.
|
(3) |
Reflects
the grant in April 2005 equal to 3% of the outstanding shares and
other
options made.
|
(4) |
684,473
options were granted to Mr. Derbin under the 2005 option plan of
which
256,677 options were surrendered pursuant to a termination of employment
agreement.
|
Number
Of Securities
Underlying
Unexercised Options
At
Fiscal
Year-End(1)
|
Value
Of Unexercised
In-The-Money
Options
At
Fiscal Year-End($)(2)
|
||||||||||||||||||
Name
|
Year
|
Shares
Acquired On
Exercise
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|||||||||||||
Roni
Appel (3)
|
2006
|
0
|
997,045
|
1,382,045
|
$
|
-
|
$
|
-
|
|||||||||||
Secretary, Chief Financial |
2005
|
0 | 254,075 | 951,835 | $ |
-
|
$ | - | |||||||||||
Officer,
and Director
|
2004
|
0
|
91,567
|
- |
$
|
-
|
$
|
-
|
|||||||||||
J. Todd Derbin |
2006
|
|
0 | 1,356,236 |
(4)
|
- | $ | 4,445 | - | ||||||||||
President, Chief Executive Officer, and |
2005
|
0 | 1,273,135 | 83,101 | $ | 47,033 | $ | 4,017 | |||||||||||
Director
|
2004
|
0
|
586,382
|
586,382
|
$
|
53,947
|
$ |
51,015
|
|||||||||||
Dr. John Rothman
|
2006
|
0 | 135,000 | 375,000 | $ | - | $ | - | |||||||||||
VP
Clinical Development
|
2005
|
0
|
-
|
360,000
|
$
|
-
|
$
|
-
|
|||||||||||
Fred Cobb |
2006
|
0
|
-
|
300,000
|
$
|
-
|
$
|
6,000
|
|||||||||||
Vice
President Finance
|
|
|
|
|
|
|
|
|
|||||||||||
Dr. Vafa Shahabi |
2006
|
0 |
56,250
|
343,750 | $ | - | $ | 6,000 | |||||||||||
Head
Director of Science
|
2005
|
0
|
|
150,000
|
$
|
-
|
$
|
-
|
(1) | Certain of the options are immediately exercisable 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 ending October 31, 2006 is based on the
closing price of $0.20 per share. In 2005 the price is based on a
price
per share of $0.25, the highest-bid price on October 31, 2005 quoted
on
the OTC:BB. 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.
|
(3) |
As
of December 15, 2006 all Mr. Appel’s options become fully vested and are
exercisable until the end of the
contract.
|
(4) |
As
of January 1, 2007 all these options were unexercised and
forfeited.
|
· |
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
and each person who owns less than 5% but is significant
nonetheless;
|
· |
each
of our directors;
|
· |
our
chief executive officer and each of our executive officers;
and
|
· |
all
of
our directors and executive officers as
a group.
|
Name
and Address of Beneficial Owner
|
Number
of Shares of
Registrant
Common Stock
Beneficially
Owned as of
October
31, 2006
|
Percentage
of Class
Beneficially
Owned
|
|||||
J.
Todd Derbin(1)
|
2,195,033
(3
|
)
|
5.2
|
%
|
|||
Roni
Appel(1)(2)
|
6,355,378
(4
|
)
|
14.6
|
%
|
|||
Richard
Berman(1)
|
476,000
(5
|
)
|
1.2
|
%
|
|||
Dr.
James Patton(1)
|
2,893,829
(6
|
)
|
7.2
|
%
|
|||
Dr.
Thomas McKearn(1)
|
524,876
(7
|
)
|
1.3
|
%
|
|||
Martin
R. Wade III(1)
|
150,000
(8
|
)
|
0.4
|
%
|
|||
Dr.
John Rothman(2)
|
724,732
(9
|
)
|
1.8
|
%
|
|||
Fredrick
Cobb(2)
|
349,641
(10
|
)
|
0.9
|
%
|
|||
Estate
of Scott Flamm(1)
|
2,838,664
(11
|
)
|
7.0
|
%
|
|||
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
|
15.8
|
%
|
||||
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
2,728,526
(12
|
)
|
6.8
|
%
|
|||
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
2,315,018
(13
|
)
|
5.8
|
%
|
|||
Emigrant
Capital Corp.
6
East 43 Street, 8th Fl.
New
York, NY 10017
|
2,011,950
(14
|
)
|
5.0
|
%
|
|||
Harvest
Advaxis LLC
30052
Aventura, Suite C
Rancho
Santa Margarita, CA 92688
|
2,011,950
(15
|
)
|
4.8
|
%
|
|||
Cornell
Capital Partners LP
101
Hudson Street, Suite 3700
Jersey
City, New Jersey 07302
|
2,011,950
(16
|
)
|
4.8
|
%
|
|||
All
Directors and Officers as a Group (9 people)
|
16,508,153(17
|
)
|
41.0
|
%
|
(1)
|
Director,
except for Mr. Derbin who served as a Director until his resignation
on
September 6, 2006 and Mr. Flamm served as a Director until his
death in January 2006
|
(2) |
Officer,
Mr. Appel ceased to be an officer on December 15,
2006
|
(3) |
Reflects
469,982 shares, and 1,356,236 options and 368,815 warrants to purchase
shares. Mr. Derbin resigned from the board effective September 6,
2006 and
his unexercised options expired January 1,
2007.
|
(4) |
Represents
2,976,288 shares, and 2,379,090 options owned by Mr. Appel but
does not reflect 486,470 warrants because such warrants are not
exercisable within 60 days due to the ownership in 4.99% restriction
under
the current circumstances, exercisable within the 60 Day
Period.
Per the Third Amended LVEP Consulting agreement dated December 15,
2006
Mr. Appel was authorized to be issued 1,000,000 shares and all his
previously granted options unvested became fully vested and exercisable
for the remainder of their term.
|
(5) |
Reflects
52,000 shares issued, 24,000 shares earned and 400,000
options.
|
(6) |
Reflects
2,820,576 shares, and 73,253 options but does not reflect 184,267
warrants
because such warrants under the current circumstances due to the
ownership
in 4.99% restriction, are not exercisable within 60
days.
|
(7) |
Reflects
179,290 shares, 232,763 options and 112,823
warrants.
|
(8) |
Reflects
options
|
(9) |
Reflects
80,000 shares issued, 134,732 shares earned and 510,000
options
|
(10) |
Reflects
49,641 shares earned and 300,000
options
|
(11) |
Reflects
125,772 shares and 91,567 options and owned by the estate and 2,621,325
shares beneficially owned by Flamm Family Partners LP, of which the
estate
is a partner but does not reflect 202,097 warrants because such
warrants
under the current circumstances due to the ownership in 4.99% restriction,
are not exercisable within the 60 Day Period. It
also excludes 98,664 shares owned by a family
member.
|
(12) |
Reflects
1,124,253 shares owned by Mr. Low, 1,220,998 shares and held by SEP,
but
does not include 761,971 warrants held by Mr. Low and 1,742,160 warrants
held by SEP because such warrants are not, under current circumstances,
exercisable within the 60 Day Period due to the ownership in 4.99%
restriction. 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 636,370 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 due to the ownership in 4.99% restriction.
Mr.
Low’s beneficial ownership does not also include 71,497 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 1,220,998 shares held
by SEP,
but does not include 1,742,160 warrants held by SEP or 636,370
warrants
held by Mr. Mendelbaum because such warrants are not, under the
current
circumstances, exercisable within the 60 Day Period due to the
ownership
in 4.99% restriction. 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
1,777,003 shares and 234,947 warrants, but does not include 1,507,213
warrants because such warrants are not, under current circumstances,
exercisable within the 60 Day Period due to the ownership in 4.99%
restriction. Mr. Howard Milstein is the Chairman and CEO and Mr.
John Hart
is the President of Emigrant.
|
(15) |
Reflects
2,011,950 warrants but does not reflect 1,820,803 warrants because
such
warrants are not currently exercisable within the 60 Day Period
due to the
ownership in 4.99% restriction. Mr. Robert Harvey is the manager
of
Harvest Advaxis LLC.
|
(16) |
Reflects
185,874 shares in addition to 1,826,076 warrants but excludes 2,673,924
warrants which 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. But does not include shares issueable upon conversion
of
convertible debentures along with 4,500,000 warrants of which $450,000
were converted as of January 19, 2007 converted into 2,825,628
additional
shares at an average conversion price of $0.159 per share. Therefore
if
the outstanding balance of $2,550,000 is converted into shares
at the
average conversion price of $0.159 per share it could be converted
into
16,037,736 shares. If the market price decreases or increases the
actual
number of shares converted can change materially from the actual
average
price above.
|
(17) |
Includes
an aggregate of 7,182,920 options, warrants and earned but not
issued
shares.
|
EXHIBIT
NUMBER
|
|
DESCRIPTION
OF EXHIBIT
|
|
Exhibit
3.2
|
Bylaws.
Incorporated by reference to Exhibit 10.4 to Report on Form 10QSB
filed
with the SEC on September 13, 2006.
|
Exhibit
3.3
|
Amended
and restated Certificate of Incorporation of Advaxis. Incorporated
by
reference to Exhibit Annex C to report on Schedule DEF 14A Proxy
Statement
filed with the SEC on May 15,
2006.
|
Exhibit
4.1
|
Form
of common stock certificate incorporated
by reference to Exhibit 4.1 filed with the SEC on March 9, 2006 to
the Registration Statement on Form SB-2 (File No.
333-132298)
|
Exhibit
4.2
|
Form
of Secured Convertible Debenture issued in February 2006 to Cornell
Capital Partners, LP. Incorporated
by reference to Exhibit 10.2 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
4.3
|
Form
of Warrant issued in February 2006 to Cornell Capital Partners, LP
to
purchase 4,200,000 shares of common stock. Incorporated
by reference to Exhibit 10.3 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
4.4
|
Form
of Warrant issued in February 2006 to Cornell Capital Partners, LP
to
purchase 300,000 shares of common stock. Incorporated
by reference to Exhibit 10.4 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
4.5
|
Form
of Warrant issued to purchasers in the Private Placement. Incorporated
by reference to Exhibit 4.1 to Report on Form 8K filed with the SEC
on
November 18, 2004.
|
Exhibit
4.6
|
Form
of Warrant issued to November 2004 Private Placement Agent. Incorporated
by reference to Exhibit 4.2 to Report on Form 8K filed with the SEC
on
November 18, 2004.
|
Exhibit
10.1
|
Share
and Exchange Agreement, dated as of August 25, 2004, by and among
the
Company, Advaxis and the shareholders of Advaxis. Incorporated
by reference to Exhibit 10.1 to Report on Form 8K filed with the
SEC on
November 18, 2004.
|
Exhibit
10.2
|
Securities
Purchase Agreement dated February 2, 2006 between Company and Cornell
Capital Partners, LP. Incorporated
by reference to Exhibit 10.1 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
10.3
|
Security
Agreement dated February 2, 2006 between Company and Cornell Capital
Partners, LP. Incorporated
by reference to Exhibit 10.6 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
10.4
|
Security
Agreement dated February 2, 2006 between Advaxis, Inc., a Delaware
corporation (subsidiary of the Company) and Cornell Capital Partners,
LP.
Incorporated
by reference to Exhibit 10.7 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
10.5
|
Investor
Registration Rights Agreement dated February 2, 2006 between Company
and
Cornell Capital Partners, LP. Incorporated
by reference to Exhibit 10.5 to Report on Form 8K filed with the
SEC on
February 8, 2006.
|
Exhibit
10.6
|
Form
of Securities Purchase Agreement related to the November 2004 Private
Placement, by and among the Company and the purchasers listed as
signatories thereto. Incorporated by reference to Exhibit 10.2 to
Report
on Form 8K filed with the SEC on November 18,
2004.
|
Exhibit
10.7
|
Form
of Registration Rights Agreement related to the November 2004 Private
Placement, by and among the Company and the persons listed as signatories
thereto. Incorporated by reference to Exhibit 10.3 to Report on Form
8K
filed with the SEC on November 18,
2004.
|
Exhibit
10.8
|
Form
of Standstill Agreement, by and among the Company and persons listed
on
Schedule 1 attached thereto. Incorporated by reference to Exhibit
10.4 to
Report on Form 8K filed with the SEC on November 18,
2004.
|
Exhibit
10.9
|
Amended
and Restated Employment Agreement, dated December 20, 2004, by and
between
the Company and J.Todd Derbin. Incorporated by reference to Exhibit
10.1
to Report on Form 8K filed with the SEC on December 23,
2004.
|
Exhibit
10.10
|
2004
Stock Option Plan of the Company. Incorporated by reference to Exhibit
4.1
to Report on Form S-8 filed with the SEC on December 1,
2005.
|
Exhibit
10.11**(1)
|
License
Agreement, between University of Pennsylvania and the Company dated
as of June 17, 2002, as Amended and Restated on February 13,
2007.
|
Exhibit
10.12
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004, between The Regents
of
the University of California and Advaxis, Inc. Incorporated by reference
to Exhibit 10.8 to Post-Effective Amendment filed on January 5, 2006
to
Registration Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.13
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the Company. Incorporated by reference to Exhibit 10.9 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
Exhibit
10.14
|
Government
Funding Agreement, dated as of April 5, 2004, by and between David
Carpi
and Advaxis, Inc. Incorporated by reference to Exhibit 10.10 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.15
|
Amended
and Restated Consulting and Placement Agreement, dated as of May
28, 2003,
by and between David Carpi and Advaxis, Inc., as amended. Incorporated
by
reference to Exhibit 10.11 to Post-Effective Amendment filed on January
5,
2006 to Registration Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.16
|
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. Incorporated by reference to Exhibit 10.12
to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.17
|
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A.
Cavagnaro
and Advaxis, Inc. Incorporated by reference to Exhibit 10.13 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.18
|
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges,
Inc.
and Advaxis, Inc. Incorporated by reference to Exhibit 10.14 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.19
|
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc. Incorporated by reference to Exhibit
10.15
to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.20
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and
Advaxis,
Inc. Incorporated by reference to Exhibit 10.16 to the amendment
filed on
June 9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.21
|
Securities
Purchase Agreement, dated as of January 12, 2005, by and between
the
Company and Harvest Advaxis LLC. Incorporated by reference to Exhibit
10.1
to Report on Form 8K filed with the SEC on January 18,
2005.
|
Exhibit
10.22
|
Registration
Rights Agreement, dated as of January 12, 2005, by and between the
Company
and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.2
to
Report on Form 8K filed with the SEC on January 18,
2005.
|
Exhibit
10.23
|
Letter
Agreement, dated as of January 12, 2005 by and between the Company
and
Robert T. Harvey. Incorporated by reference to Exhibit 10.3 to Report
on
Form 8K filed with the SEC on January 18,
2005.
|
Exhibit
10.24
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David
Filer
and the Company. Incorporated by reference to Exhibit 10.20 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.25
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company. Incorporated by reference to
Exhibit
10.21 to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.26
|
Agreement,
dated February 1, 2004, by and between Strategic Growth International
Inc.
and the Company. Incorporated by reference to Exhibit 10.22 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.27
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman
and the
Company. Incorporated by reference to Exhibit 10.23 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on Form
SB-2
(File No. 333-122504).
|
Exhibit
10.28
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabit and
the
Company. Incorporated by reference to Exhibit 10.24 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on Form
SB-2
(File No. 333-122504).
|
Exhibit
10.29
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
Company. Incorporated by reference to Exhibit 10.25 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on Form
SB-2
(File No. 333-122504).
|
Exhibit
10.30
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company. Incorporated by reference to
Exhibit
10.26 to the amendment filed on June 9, 2005 to Registration Statement
on
Form SB-2 (File No. 333-122504).
|
Exhibit
10.30(a)
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the Company. Incorporated by reference to Exhibit
10.27
to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.30(b)
|
Second
Amendment dated October, 31, 2005 to Consultancy Agreement between
LVEP
Management LLC and the Company. Incorporated by reference to Exhibit
10.2
to Report on Form 8K filed with the SEC on November 9,
2005.
|
Exhibit
10.31
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the Company. Incorporated by reference
to
Exhibit 10.28 to Post-Effective Amendment filed on January 5, 2006
to
Registration Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.32
|
Letter
Agreement between the Company and Investors Relations Group Inc.,
dated
September 27, 2005. Incorporated by reference to Exhibit 10.31 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
10.33
|
Consultancy
Agreement between the Company and Freemind Group LLC, dated October
17,
2005. Incorporated by reference to Exhibit 10.32 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on Form
SB-2
(File No. 333-122504).
|
Exhibit
10.34
|
Strategic
Collaboration and Long Term Vaccine Supply Agreement between the
Company
and Colera BioManufacturing PLC, dated October 31, 2005. Incorporated
by
reference to Exhibit 10.33 to Post-Effective Amendment No. 2 to
Registration Statement on Form SB-2 (File No.
333-122504).*
|
Exhibit
10.35
|
Employment
Agreement dated February 9, 2006 between the Company and Frederick
D.
Cobb. Filed on March 9, 2006 with the initial filing of the Registration
Statement on Form SB-2 (File No. 333-132298)
|
Exhibit
10.36
|
Resignation
Agreement between J. Todd Derbin and the Company dated October 31,
2005.
Incorporated by reference to Exhibit 10.1 report on Form 8-K filed
with
the SEC on November 9, 2005.
|
Exhibit
10.37
|
Third
Amendment dated
December 15, 2006 to Consultancy between LVEP Management LLC and
Company
Incorporated by reference to Exhibit 9.01 reported on Form 8-K filed
with
the SEC December 15, 2006.
|
Exhibit
10.38
|
2005
Stock Option Plan of the Company. Incorporated by reference to Exhibit
Annex A to report on Schedule DEF 14A Proxy Statement filed with
the SEC
on May 15, 2006.
|
Exhibit
10.39
|
Agreement
and Plan of Merger dated March 29, 2006. Incorporated by reference
to
Exhibit Annex B to report on Schedule DEF 14A Proxy Statement filed
with
the SEC on May 15, 2006.
|
Exhibit
10.40**
|
Consulting
Agreement dated June 1, 2006 by and between The Biologics Consulting,
Inc.
and the Company.
|
Exhibit
10.41**
|
Consultancy
Agreement Change Order dated December 4, 2006 by and between Pharm-Olam
International Ltd. and the Company.
|
Exhibit
10.42**
|
Agreement
dated October 28, 2006 by and between Apothecaries Ltd. and the
Company
|
Exhibit
10.43**
|
Third
Lease Amendment Agreement dated October 1, 2006 by and between the
New
Jersey Economic Development Authority and the
Company.
|
Exhibit
10.44**
|
Sponsored
Research Agreement dated November 1, 2006 by and between University
of
Pennsylvania (Dr. Paterson Principal Investigator) and the
Company.
|
Exhibit
14.1
|
Code
of Ethics. Incorporated by reference to Exhibit 14.1 to Report on
Form 8K
filed with the SEC on November 18,
2004.
|
Exhibit
21.1
|
Advaxis,
Inc., a Delaware corporation. Incorporated by reference to Exhibit
21.1 to
post-effective amendment no. 1 to Form SB-2 filed with the SEC on
January
5, 2006
|
Exhibit
24.1
|
Power
of Attorney (Included on the signature
page)
|
Exhibit
31.1
|
|
Rule 13a-14(a)/15d-14(a)
Certification by the Chief Executive Officer (filed
herewith).
|
|
Exhibit
31.2
|
|
Rule 13a-14(a)/15d-14(a)
Certification by the Principal Financial Officer (filed
herewith).
|
|
Exhibit
32.1
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|
Certification
by the Chief Executive Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (filed herewith).
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Exhibit
32.2
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Certification
by the Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (filed herewith).
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Fiscal
Year 2006
|
Fiscal
year 2005
|
||||||
Audit
Fees
|
$
|
35,000
|
$
|
29,500
|
|||
Audit-Related
Fees
|
20,855
|
61,992
|
|||||
Tax
Fees
|
0
|
0
|
|||||
All
Other Fees
|
0
|
0
|
|||||
Total
|
$
|
55,855
|
$
|
91,492
|
ADVAXIS,
INC.
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||
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By: | /s/ Thomas Moore | |
Thomas
Moore, Chief
Executive Officer and Chairman of the Board
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SIGNATURE
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TITLE
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DATE
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/s/
Thomas Moore
Thomas
Moore
|
|
Chief
Executive Officer and Chairman of the Board
(Principal
Executive Officer)
|
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February
13, 2007
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|
/s/ Fredrick
Cobb
Fredrick
Cobb
|
|
Vice
President, Finance
(Principal
Financial and Accounting Officer)
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|
February
13, 2007
|
|
/s/ Roni
Appel
Roni
Appel
|
|
Director
|
|
February
13, 2007
|
|
/s/
Thomas McKearn
Thomas
McKearn
|
|
Director
|
|
February
13, 2007
|
|
/s/
James Patton
James
Patton
|
|
Director
|
|
February
13, 2007
|
|
/s/
Richard Berman
Richard
Berman
|
|
Director
|
|
February
13, 2007
|
|
/s/
Martin Wade
Martin
Wade
|
Director
|
February
13, 2007
|