Colorado
(State
or other jurisdiction 0of
incorporation
or organization)
|
84-1521955
(I.R.S.
Employer Identification No.)
|
212
Carnegie Center
Suite
206
Princeton,
New Jersey
|
08540
|
(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 - $.01 par value
The
Common Stock is listed on the American Stock Exchange
|
Securities
registered pursuant to Section 12(g) of the Act:
|
[None]
|
PAGE
|
||||
Item
1.
|
Business
|
1
|
||
Item
2.
|
Properties
|
43
|
||
Item
3.
|
Legal
Proceedings
|
44
|
||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
45
|
||
PART
II
|
||||
Item
5.
|
Market
for the Registrant’s Common Equity and
|
|||
|
Related
Stockholder Matters
|
46
|
||
Item
6.
|
Management’s
Discussion and Analysis of Financial
|
47
|
||
Item
7.
|
Financial
Statements and Supplementary Data
|
59
|
||
Item
8.
|
Changes
in and Disagreements with Accountants
|
|||
|
on
Accounting and Financial Disclosure
|
80
|
||
Item
8A.
|
Controls
and Procedures
|
81
|
||
Item
8B
|
Other
Information
|
82
|
||
PART
III
|
||||
Item
9.
|
Directors
and Executive Officers of the Registrant
|
83
|
||
Item
10.
|
Executive
Compensation
|
88
|
||
Item
11.
|
Security
Ownership of Certain Beneficial Owners
|
|||
|
and
Management and Related Stockholder Matters
|
94
|
||
Item
12.
|
Certain
Relationships and Related Transactions
|
98
|
||
Item
13.
|
Exhibits
|
100
|
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 late 2006
|
|
Lovaxin
W
|
|
Wilms
tumor and leukemia
|
|
Pre-clinical;
|
|
Lovaxin
T
|
|
Cancer
through control of telomerase
|
|
Pre-clinical
|
|
Lovaxin
H
|
|
Prophylactic
vaccine for HIV (AIDS)
|
|
Pre-clinical
|
|
· |
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.
|
1 |
PEST
is a part of the LLO protein that is believed to facilitate rapid
degradation of LLO in the cytoplasm. It appears to facilitate movement
of
the protein into the endoplasmic reticulum of the cell. In Advaxis’
application, the PEST sequence enhances the cell-mediated response
to an
attached antigen, presumably by preferential movement of the antigen
sequence in to the intracellular protein processing system of antigen
processing cells such as macrophages and dendritic
cells.
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinincal;
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
|
Ovarian
melanoma and lung cancer
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical
|
||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clinical
|
||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clinical
|
||
|
|
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 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.
|
|
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.
|
· |
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 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.
|
· |
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.
|
Quarter ended | High | Low |
Fiscal Year ended October 31, 2005 | $ 1.25 | $ 0.12 |
December 31, 2005 | $ 0.25 | $ 0.15 |
· |
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 to date: approximately
$1,000,000
|
· |
Estimated
future costs: $700,000
|
· |
Anticipated
completion date: late 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 to date: $300,000
|
· |
Estimated
future costs: $1,800,000
|
· |
Anticipate
completion dates: second quarter of
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
collaberation 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: third quarter of
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 collaberation subject to regulatory approval to market
and sell
the product.
|
· |
Cost
incurred to date: $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 collaberation subject to regulatory approval to market
and sell
the product.
|
Year
Ended October 31, 2005 Compared to the Year Ended October 31,
2004
|
· |
an
increase in our related manufacturing expenses of $416,842 or 5,710%
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;
|
· |
an
increase in expenses related to toxicology studies from $0 to $293,105;
such increase reflects 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;
|
· |
an
increase in wages and salaries related to our research and development
program from $0 to $166,346; such increase reflects the recruitment
of our
R&D management team in early
2005.
|
· |
an
increase in subcontracted work of $141,366 or 100% from $0 to $141,366;
such increase reflects the subcontract work performed by Dr. Paterson
at
Penn, pursuant to certain grants.
|
· |
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.
|
· |
A
decrease in our manufacturing expenses of $228,452 or 103.9% from
$219,948
to $(8,504); such decrease reflects the delay in the manufacturing
program
during 2004 because of delays in
funding;
|
· |
A
decrease in our License Fees of $110,164 or 196.4% from $56,082 to
$(54,082); such decrease reflects 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 year 2004 of our expenses resulting
from our sponsored research agreement with Penn;
and
|
· |
Development
consulting expenses increased from $72,988 to $150,147 or 105.7%.
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%, from $154,512 for
the ten
months ended October 31, 2003 to $189,302 for the ten months ended
October
31, 2004 arising from a bonus to Mr. Derbin, the Chief Executive
Officer,
in stock;
|
· |
professional
fees increased by $14,368 from $204,145 for the ten months ended
October
31, 2003 to $218,514 for the ten months ended October 31, 2004 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 from $1,901 for the ten months ended October
31,
2003 to $9,929 for the ten months ended October 31, 2004;
and
|
· |
Other
General and Administrative expenses increased by $66,701 from $14,844
to
$81,545 principally due to an increase in amortization expenses,
information technology and internet expenses, postage, telephone
and
travel expenses.
|
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,
|
|
Tenth
Month
Period
ended
October
31
|
|
Year
ended
October
31,
|
|
Period
from March 1,
2002
(inception) to
October
31,
|
|
|
|
|
2003
|
|
2004
|
|
2005
|
|
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
|
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
|
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
|
)
|
$
|
(3,20,546
|
)
|
|
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
|
)
|
|
|
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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. |
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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. Both the 2004 plan
and the 2005 plan shall 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
|
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
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
a
$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 valued 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 shall 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 Shahabi
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. Shahabi will be granted 150,000
options.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
The
Company entered into an employment agreement with Dr. John Rothman,
Ph.D
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
7.
INCOME
TAXES:
|
The
Company has a net operating loss carry forward of approximately $2,619,000
at October 31, 2005 available to offset taxable income through 2025.
|
|
|
|
|
|
The
tax effects of loss carryforwards 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
|
1-Mar-02
|
|||||||||
|
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
|
Name
|
Age
|
Position
|
||
J.
Todd Derbin(3) (4)
|
53
|
Chairman
of the Board of Directors
|
||
Dr.
James Patton(1)
|
48
|
Director
|
||
Roni
A. Appel(3) (4)
|
39
|
President,
Chief Executive Officer, Chief Financial Officer, Secretary and
Director
|
||
Dr.
Thomas McKearn(2)
|
56
|
Director
|
||
Richard
Berman (4) (2) (1)
|
63
|
Director
|
(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
|
· |
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 suggest 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
|
Salary($)
|
Bonus($)
|
Securities
Underlying
Options
|
|||
J.
Todd Derbin
Director
(former CEO)
|
2005
2004(1)
2003
|
$225,000
$125,000
$150,000
|
$45,000
$60,000(4)
|
684,473
(6)
--
1,172,727
(6)
|
|||
Dr.
James Patton
Chairman
of the Board of Directors
|
2005
2004(1)
2003
|
--
$15,000(2)
$15,750(2)
|
--
--
--
|
28,175
33,810
|
|||
Roni
Appel
Secretary,
Chief Financial Officer, and Director
|
2005
2004(1)
2003
|
$139,250
(5)
$50,000(3)
$60,000(3)
|
$35,000
|
1,114,344
(5)
35,218
42,262
|
(1)
Information for 2004 reflects the ten month period ended October
31,
2004.
(2)
Dr. Patton was paid consulting fees by the Company of $18,000 in
2003 and
$15,750 in 2004. Dr. Patton’s compensation related to his consulting
agreement which was terminated on November 2004.
(3)
Mr. Appel was paid consulting fees of $60,000 in 2003 and consulting
fees
of $50,000 in the 10 months ended October 31, 2004 through his
beneficial
ownership of Carmel Ventures, Inc. $35,000 of such fees were assigned
to
Mr. Scott Flamm.
(4)
Mr. Derbin’s stock option award was based in his employment contract. His
2003 bonus of $60,000 was paid in 2004 in Common Stock of the Company
on
the basis of a price of $0.1952 per share and
was two-third’s of his maximum bonus of $90,000. The basis for this bonus
was the successful conclusion of several matters of great importance
to
the Company including:
- extending
the patent portfolio and moving it to the care of competent patent
counsel;
- creating
grant opportunities for the company;
- scaling
up manufacturing; and
- creating
certain collaboration opportunities.
In
determining Mr. Debin’s bonus, the Board acted in part on a discretionary
basis.
(5)
Mr. Appel’s compensation in year 2005 was paid through a consulting
agreement between the company and LVEP Management, LLC. See “Certain
Relationships and Related Party Transaction” at p.98.
(6)
Pursuant to a termination of employment agreement, only 928,441
options of
the 2004 grant vested, and only 427,796 options of the 2005 grant
vested.
The balance of the options were surrenderd to the
company.
|
|
|
Individual
Grants
|
|
||||
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation
For
|
||||||
|
Option
Term($)
|
||||||
Name
|
Year
|
Number
Of Securities Underlying Options
Granted
|
Percent
Of Total Options Granted To Employees In Fiscal
Year)
|
Exercise
Price
|
Expiration
Date
|
5%
|
10%
|
J.
Todd Derbin(1)
|
2005
|
684,473
|
100%
|
$0.29
|
12/15/2014
|
$
26,543.13
|
$142,486.07
|
Director
(former
CEO)
|
2004
|
--
|
0%
|
--
|
--
|
-
|
-
|
|
2003
|
--
|
0%
|
--
|
--
|
-
|
-
|
Dr.
James Patton
|
2005
|
5,635
|
8%
|
$0.35
|
11/1/2012
|
$
218.52
|
$
1,173.03
|
Chairman
of the Board of Directors
|
2004
|
28,175
|
42%
|
$0.35
|
11/1/2012
|
$
1,092.60
|
$
5,865.16
|
|
2003
|
33,810
|
50%
|
$0.35
|
11/1/2012
|
$
1,311.12
|
$
7,038.19
|
Roni
Appel
|
2005
|
1,114,344
|
93%
|
$0.29
|
3/31/2015
|
$
43,213.06
|
$231,971.89
|
Secretary,
Chief Financial Officer, and Director
|
2004
|
35,218
|
3%
|
$0.35
|
11/1/2012
|
$
1,365.72
|
$
7,331.30
|
|
2003
|
42,262
|
4%
|
$0.35
|
11/1/2012
|
$
1,638.87
|
$
8,797.64
|
|
|
|
|
Number
Of Securities
|
Value
Of Unexercised
|
||
Underlying
Unexercised Options
|
In-The-Money
Options
|
||||||
At
Fiscal Year-End(2)
|
At
Fiscal Year-End($)(3)
|
||||||
|
Shares
Acquired On
Exercise
|
|
|||||
|
|
||||||
|
|
|
|||||
Name
|
Year
|
Value
Realized(1)
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|
J.
Todd Derbin
|
2005
|
0
|
$
-
|
1,273,135
|
584,106
|
$
47,033
|
$
17,469
|
Director
(former CEO)
|
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
|
-
|
$
-
|
$
-
|
Chairman
of the Board of Directors
|
2004
|
0
|
$
-
|
29,583
|
-
|
$
-
|
$
-
|
|
2003
|
0
|
$
-
|
33,810
|
-
|
$
-
|
$
-
|
|
|
|
|
|
|
|
|
Roni
Appel
|
2005
|
0
|
$
-
|
254,075
|
951,835
|
$
-
|
$
-
|
Secretary,
Chief Financial
Officer,
and Director
|
2004
|
0
|
$
-
|
91,567
|
-
|
$
-
|
$
-
|
|
2003
|
0
|
$
-
|
49,305
|
-
|
$
-
|
$
-
|
(1) |
Based
on the fair market value of our common stock on the date of exercise,
less
the exercise price payable for such shares.
|
(2) |
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.
|
(3) |
The
price for end of fiscal year 2005 is based on a price per share of
$0.25.
The price for previous years is based on the fair market value of
our
common stock at fiscal year end of $0.25 per share, 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
|
Number
of Shares of Registrant
Common Stock Beneficially
Owned
|
Percentage
of Class Beneficially
Owned(1)
|
||
Name
and Address of Beneficial Owner
|
Shares
of Common Stock Beneficially Owned
|
Percentage
of Class Beneficially Owned
|
||
J.
Todd Derbin(1)(2)
|
2,204,390
(3)
|
5.59%
|
||
Roni
Appel(1)(2)
|
4,016,467
(4)
|
10.31%
|
||
Estate
of Scott Flamm(1)
|
2,914,989
(5)
|
7.72%
|
||
Richard
Berman (1)
|
400,000
(6)
|
1.05%
|
||
Dr.
James Patton(1)
|
2,913,476
(6a)
|
7.92%
|
||
Dr.
Thomas McKearn(1)
|
306,601
(7)
|
0.08%
|
||
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
|
17.2%
|
||
Sunrise
Equity Partners, LP
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
(8)
|
4.99%
|
||
Level
Counter, LLC
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
(9)
|
4.99%
|
||
Marilyn
Adler
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
1,835,491
(10)
|
4.99%
|
||
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
3,346,311
(11)
|
9.10%
|
||
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Ave-25fl
New
York, NY 10022
|
2,932,803
(12)
|
7.97%
|
||
Emigrant
Capital Corp.
6
East 43 Street, 8th Fl.
New
York, NY 10017
|
1,838,783
(13)
|
4.99%
|
||
Harvest
Advaxis LLC
30052
Aventura, Suite C
Rancho
Santa Margarita, CA 92688
|
(14)
|
|||
All
Directors and Officers as a Group (6 people)
|
13,215,699
|
35.07%
|
(1) |
Director
or former director
|
(2)
|
Officer
or former officer
|
(3)
|
Reflects
469,338 shares of Common Stock, 1,356,236 options to purchase shares
of
common stock and 368,815 warrants to purchase shares of Common
Stock.
|
(4)
|
Reflects
14,449 warrants to purchase shares of Common stock and 2,382,666
shares of
Common Stock owned by Mr. Appel and 1,114,344 options to purchase
shares
of Common Stock but does not reflect 58,580 warrants to purchase
shares of
Common Stock because such warrants are not under the current
circumstances, exercisable within the next 60 days. Also reflects
355,528
shares of common stock and 149,480 options and warrants to
purchase shares
of Common Stock beneficially owned by Carmel Ventures, Inc.
of which Mr.
Appel is a controlling person but does not reflect 355,538
warrants to
purchase shares of common stock owned by Carmel Ventures, Inc.
because
such warrants are not under the current circumstances exercisable
within
the next 60 days.
|
(5) |
Reflects
125,772 shares of common stock and 122,751 options and warrants to
purchase shares of Common Stock owned by Mr. Flamm but does not reflect
125,722 warrants to purchase shares of Common Stock because such
warrants
are not under the current circumstances, exercisable within the next
60
days. Also reflects 2,621,325 shares of Common Stock and 45,141 warrants
to purchase shares of Common Stock beneficially owned by Flamm Family
Partners LP of which Mr. Flamm is a
partner.
|
(6) |
Reflects
options to purchase shares of Common
Stock.
|
(6a) |
Reflects
56,349 options to purchase shares of common stock, 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 under the current circumstances, exercisable
within the next 60 days.
|
(7) |
Reflects195,586
options and warrants to purchase shares of common stock and 111,015
shares
of common stock.
|
(8) |
Reflects
1,742,160 shares of common stock held by Sunrise Equity Partners,
LP
("SEP") and warrants to purchase 93,331 shares of common stock, but
does
not include warrants to purchase 1,648,829 shares of common stock
issuable
upon exercise of warrants held by SEP because such warrants are not,
under
the current circumstances, exercisable within the next 60 days. 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. The 1,835,491 shares
of common stock beneficially held by SEP also does not
include: (1) 1,124,253 shares of common stock directly owned by
Nathan Low or warrants directly owned by Mr. Low to purchase up to
761,971
shares of common stock; (2) 1,094,020 shares of directly owned by
Amnon
Mandelbaum or warrants directly owned by Mr. Mandelbaum to purchase
up to
672,539 shares of common stock, and (3) shares of common stock 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. Does not reflect the 34,843 shares of
common
stock issuable as penalty shares.
|
(9) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. LC is the general partner of
SEP and
as such, is deemed to have beneficial ownership of the securities
held by
SEP for purposes of calculating percentage interest. Does not reflect
the
34,843 shares of common stock issuable to SEP as penalty
shares.
However, LC disclaims beneficial interest in such shares except to
the
extent of its pecuniary interest therein.
|
(10) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843
shares of
common stock issuable to SEP as penalty shares. 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
for
purposes of calculating percentage interest. However, Ms. Adler disclaims
beneficial interest in such shares except to the extent of her pecuniary
interest therein.
|
(11) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843
shares of
common stock issuable to SEP as Penalty Shares. 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 for purposes
of
calculating percentage interest. However, Mr. Low disclaims beneficial
interest in such shares except to the extent of his pecuniary interest
therein. Also reflects 1,124,253 shares of common stock owned by
Mr. Low
but does not reflect warrants to purchase 761,971 shares of common
stock
issuable upon exercise of such warrants because such warrants are
not,
under the circumstances, exercisable within the next 60 days nor
does it
reflect 37,725 shares of common stock issuable to Mr. Low as Penalty
Shares. Also includes 383,275 shares of common stock held by Sunrise
Securities Corp., a corporation of which Mr. Low is sole stockholder
and
director, but does not include warrants to purchase 348,432 shares
of
common stock held by Sunrise Securities Corp. because such warrants
are
not, under the circumstances, exercisable within the next 60 days
nor does
it reflect 14,634 shares of common stock issuable to Sunrise Securities
Corp. as penalty shares. Mr. Low’s beneficial ownership does not include
shares of common stock held by Sunrise Foundation Trust, a charitable
trust of which Mr. Low is a trustee. Mr. Low disclaims beneficial
ownership of such shares of common stock held by Sunrise Foundation
Trust.
|
(12) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843
shares of
common stock issuable to SEP as Penalty Shares. 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
for
purposes of calculating percentage interest. However, Mr. Mandelbaum
disclaims beneficial interest in such shares except to the extent
of his
pecuniary interest therein. Also reflects 1,094,020 shares of common
stock
owned by Mr. Mandelbaum but does not reflect warrants to purchase
672,539
shares of common stock issuable upon exercise of such warrants because
such warrants are not, under the circumstances, exercisable within
the
next 60 days nor does it reflect 35,332 shares of common stock issuable
to
Mr. Mandelbaum as penalty hares.
|
(13) |
Reflects
1,742,160 shares of common stock held by Emigrant Capital Corp.
(“Emigrant”) and warrants to purchase 16,623 shares of common stock, but
does not include warrants to purchase 1,645,537 shares of common
stock
issuable upon exercise of warrants held by Emigrant because such
warrants
are not, under the current circumstances, exercisable within the
next 60
days nor does it reflect 34,843 shares of common stock issuable to
Emigrant as penalty shares. Mr. Howard Milstein is the Chairman and
CEO
and Mr. John Hart is the President of
Emigrant.
|
(14) |
Does
not reflect warrants to purchase 3,832,753 shares of common stock
because
such warrants are not currently exercisable within the next 60 days.
Mr.
Robert Harvey is the manager of Harvest Advaxis LLC.
|
EXHIBIT
NUMBER
|
DESCRIPTION
OF EXHIBIT
|
||
|
|
||
Exhibit
3.1
|
Amended
and Restated Articles of Incorporation. Incorporated by reference
to
Exhibit 4.2 to Report on Form S-8 filed with the SEC on December
1, 2005.
|
||
|
|
||
Exhibit
3.2
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 3.1 to
Report on
Form 8K filed with the SEC on December 27, 2004.
|
||
|
|
||
Exhibit
4.1
|
Form
of Warrant issued to purchasers. Incorporated by reference to Exhibit
4.1
to Report on Form 8K filed with the SEC on November 18, 2004.
|
||
|
|
||
Exhibit
4.2
|
Form
of Warrant issued to 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
|
Form
of Securities Purchase Agreement, 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
10.3
|
Form
of Registration Rights Agreement, 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
10.4
|
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
10.5
|
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
10.6
|
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
10.7
|
License
Agreement, dated as of June 17, 2002, by and between Advaxis and
The
Trustees of the University of Pennsylvania. Incorporated by reference
to
Exhibit 10.7 to Post-Effective Amendment No. 1 to Form SB-2 filed
with the
SEC on January 5, 2006.*
|
||
|
|
||
Exhibit
10.8
|
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 No. 1 to Form SB-2 filed
with
the SEC on January 5, 2006.*
|
||
|
|
||
Exhibit
10.9
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.10
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
Exhibit
10.11
|
Amended
and Restated Consulting and Placement Agreement, dated as of May28,
2003,
by and between David Carpi and Advaxis, Inc., as amended. Incorporated
by
reference to Exhibit 10.11to Post-Effective Amendment No. 1 to Form
SB-2
filed with the SEC on January 5, 2006.*
|
||
|
|
||
Exhibit
10.12
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.13
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|||
Exhibit
10.14
|
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges,
Inc.
and Adavaxis, Inc. Incorporated by reference to Exhibit 10.14 to
Post-Effective Amendment No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.15
|
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 No. 1 to Form SB-2 filed with the SEC
on
January 5, 2006.*
|
||
|
|
||
Exhibit
10.16
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and
Advaxis,
Inc. Incorporated by reference to Exhibit 10.16 to Post-Effective
Amendment No. 1 to Form SB-2 filed with the SEC on January 5,
2006.*
|
||
|
|
||
Exhibit
10.17
|
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
10.18
|
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
10.19
|
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
10.20
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.21
|
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 No. 1 to Form SB-2 filed with the
SEC on
January 5, 2006.*
|
||
|
|
||
Exhibit
10.22
|
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 No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.23
|
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 No. 1 to Form SB-2 filed with the SEC on January 5,
2006.*
|
||
|
|
||
Exhibit
10.24
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and
the
Company. Incorporated by reference to Exhibit 10.24 to Post-Effective
Amendment No. 1 to Form SB-2 filed with the SEC on January 5, 2006.*
|
||
|
|
||
Exhibit
10.25
|
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 No. 1 to Form SB-2 filed with the SEC on January 5,
2006.*
|
||
|
|
||
Exhibit
10.26
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company. Incorporated by reference to
Exhibit
10.26 to Post-Effective Amendment No. 1 to Form SB-2 filed with the
SEC on
January 5, 2006.*
|
||
|
|
||
Exhibit
10.27
|
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 No. 1 to Form SB-2 filed with the SEC
on
January 5, 2006.*
|
||
|
|
||
Exhibit
10.28
|
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 No. 1 to Form SB-2 filed
with
the SEC on January 5, 2006.*
|
||
|
|
||
Exhibit
10.29
|
Resignation
Agreement between J. Todd Durbin and the Company, dated October 31,
2005. Incorporation by reference to Exhibit 10.1 to report on Form
8-K filed with the SEC on November 9, 2005. *
|
|
|
||
Exhibit
10.30
|
Second
Amendment to Consulting Agreement between the Company and LVEP Management
LLC, dated October 31, 2005. Incorporation by reference to Exhibit
10.2 to Report on Form 8-K filed with the SEC on November 9, 2005.
*
|
||
|
|
||
Exhibit
10.31
|
Letter
of Agreement between the Company and the Investor Relations Group
Inc.,
dated September 27, 2005. Incorporated by reference to Exhibit 10.31
to
Post-Effective Amendment No. 1 to Form SB-2 filed with the SEC on
January
5, 2006.*
|
||
|
|
||
Exhibit
10.32
|
Consulting
Agreement between the Company and Freemind Group, LLC dated October
17,
2005. Incorporated by reference to Exhibit 10.32 to Post-Effective
Amendment No. 1 to Form SB-2 filed with the SEC on January 5,
2006.
|
||
|
|
||
Exhibit
10.33
|
Strategic
Collaboration and Long Term Vaccine Supply Agreement between the
Company
and Cobra Bio-Manufacturing PLC dated October 31, 2005. Incorporated
by
reference to Exhibit 10.33 to Post-Effective Amendment No. 1 to Form
SB-2
filed with the SEC on January 5, 2006.*
|
||
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 and Chief Financial
Officer
(filed herewith).
|
||
Exhibit
32.1
|
Certification
by the Chief Executive Officer and Chief 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).
|
ADVAXIS,
INC.
|
||
|
|
|
By: | /s/ Roni Appel | |
Roni Appel, Chief Financial Officer and Chief Executive Officer |
||
SIGNATURE
|
TITLE
|
DATE
|
|||
/s/ Roni
Appel
Roni
Appel
|
Chief
Executive Officer and Director
(Principal
Executive Officer)
|
January
25, 2006
|
|||
/s/ Roni
Appel
Roni
Appel
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
January
25, 2006
|
|||
/s/
J. Todd Derbin
J.
Todd Derbin
|
Director
|
January
25, 2006
|
|||
/s/
Thomas McKearn
Thomas
McKearn
|
Director
|
January
25, 2006
|
|||
/s/
James Patton
James
Patton
|
Director
|
January
25, 2006
|
|||
/s/
Richard Berman
Richard
Berman
|
Director
|
January
25, 2006
|
EXHIBIT
NUMBER
|
DESCRIPTION
OF EXHIBIT
|
||
|
|
||
Exhibit
3.1
|
Amended
and Restated Articles of Incorporation. Incorporated by reference
to
Exhibit 4.2 to Report on Form S-8 filed with the SEC on December
1, 2005.
|
||
|
|
||
Exhibit
3.2
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 3.1 to
Report on
Form 8K filed with the SEC on December 27, 2004.
|
||
|
|
||
Exhibit
4.1
|
Form
of Warrant issued to purchasers. Incorporated by reference to Exhibit
4.1
to Report on Form 8K filed with the SEC on November 18, 2004.
|
||
|
|
||
Exhibit
4.2
|
Form
of Warrant issued to 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
|
Form
of Securities Purchase Agreement, 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
10.3
|
Form
of Registration Rights Agreement, 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
10.4
|
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
10.5
|
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
10.6
|
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
10.7
|
License
Agreement, dated as of June 17, 2002, by and between Advaxis
and The
Trustees of the University of Pennsylvania. (1)
|
||
|
|
||
Exhibit
10.8
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004, between The
Regents of
the University of California and Advaxis, Inc. (1)
|
||
|
|
||
Exhibit
10.9
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP
Management,
LLC. and the Company. (1)
|
||
|
|
||
Exhibit
10.10
|
Government
Funding Agreement, dated as of April 5, 2004, by and between
David Carpi
and Advaxis, Inc. (1)
|
Exhibit
10.11
|
Amended
and Restated Consulting and Placement Agreement, dated as of
May28, 2003,
by and between David Carpi and Advaxis, Inc., as amended.
(1)
|
||
|
|
||
Exhibit
10.12
|
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. (1)
|
||
|
|
||
Exhibit
10.13
|
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy
A. Cavagnaro
and Advaxis, Inc. (1)
|
||
|
|||
Exhibit
10.14
|
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges,
Inc.
and Adavaxis, Inc. (1)
|
||
|
|
||
Exhibit
10.15
|
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel
Consulting
Corporation and Advaxis, Inc. (1)
|
||
|
|
||
Exhibit
10.16
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC
and Advaxis,
Inc. (1)
|
||
|
|
||
Exhibit
10.17
|
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
10.18
|
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
10.19
|
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
10.20
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David
Filer
and the Company. (1)
|
||
|
|
||
Exhibit
10.21
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company. (1)
|
||
|
|
||
Exhibit
10.22
|
Agreement,
dated February 1, 2004, by and between Strategic Growth International
Inc.
and the Company. (1)
|
||
|
|
||
Exhibit
10.23
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman
and the
Company. (1)
|
||
|
|
||
Exhibit
10.24
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi
and the
Company. (1)
|
||
|
|
||
Exhibit
10.25
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and
the
Company. (1)
|
||
|
|
||
Exhibit
10.26
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company. (2)
|
||
|
|
||
Exhibit
10.27
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between
LVEP
Management LLC and the Company (filed herewith).
|
||
|
|
||
Exhibit
10.28
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the Company (2).
|
||
|
|
||
Exhibit
10.29
|
Resignation
Agreement between J. Todd Durbin and the Company, dated October
31,
2005. Incorporation by reference from report on Form 8-K filed
with the SEC on November 9, 2005.
|
|
|
||
Exhibit
10.30
|
Second
Amendment to Consulting Agreement between the Company and LVEP
Management
LLC, dated October 31, 2005. Incorporation by reference to Exhibit
10.2 to Report on Form 8-K filed with the SEC on November 9,
2005.
|
||
|
|
||
Exhibit
10.31
|
Letter
of Agreement between the Company and the Investor Relations Group
Inc.,
dated September 27, 2005. (3)
|
||
|
|
||
Exhibit
10.32
|
Consulting
Agreement between the Company and Freemind Group, LLC dated October
17,
2005. (3)
|
||
|
|
||
Exhibit
10.33
|
Strategic
Collaboration and Long Term Vaccine Supply Agreement between
the Company
and Cobra Bio-Manufacturing PLC dated October 31, 2005.
(3)
|
||
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
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 and Chief Financial
Officer
(filed herewith).
|
||
Exhibit
32.1
|
Certification
by the Chief Executive Officer and Chief 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).
|