Ayala Pharmaceuticals, Inc. - Annual Report: 2010 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
x ANNUAL REPORT
UNDER SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE FISCAL YEAR ENDED - OCTOBER 31, 2010
OR
¨
TRANSITION REPORT UNDER
SECTION 13 OR 15 (d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE TRANSITION PERIOD FROM ______ TO ______
COMMISSION FILE NUMBER 000-28489
ADVAXIS,
INC.
(Name
of Registrant in Its Charter)
Delaware
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
02-0563870
(I.R.S.
Employer Identification No.)
|
Technology
Centre of New Jersey
675
US Highway One
North
Brunswick, New Jersey
(Address
of Principal Executive Offices)
|
08902
(Zip
Code)
|
(732)
545-1590
(Issuer’s
Telephone Number)
|
|
Securities registered under Section 12(b) of the Exchange Act:
|
Common Stock - $.001 par value
The Common Stock is listed on the Over-The-Counter
Bulletin
Board (OTC:BB)
|
|
|
Securities registered under Section 12(g) of the Exchange Act:
|
[None]
|
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.
Yes
¨
No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.
Yes
¨
No
x
Check whether
the Registrant (1) filed all reports required to be filed by Section 13 or 15(d)
of the Exchange Act during the past 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of
this chapter) during the preceding 12 months (or such shorter period that the
registrant was required to submit and post such files). Yes ¨ No
¨
Check if
there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-K contained in this form, and no disclosure will be contained, to
the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer”, “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No x
As of
April 30, 2010, the aggregate market value of the voting common equity held by
non-affiliates was approximately $22,116,980 based on the closing bid price of
the registrant’s common stock on the Over the Counter Bulletin Board. (For
purposes of determining this amount, only directors, executive officers, and 10%
or greater stockholders and their respective affiliates have been deemed
affiliates).
The
registrant had 210,645,862 shares of Common Stock, par value $0.001 per share,
issued and outstanding as of January 27, 2011.
Table of
Contents
Form
10-K Index
PART
1
|
1
|
|
Item
1:
|
Business
|
1
|
Item
1A:
|
Risk
Factors
|
18
|
Item
2:
|
Properties
|
27
|
Item
3:
|
Legal
Proceedings
|
28
|
Item
4:
|
Removed
and Reserved
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28
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PART
II
|
28
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|
Item
5:
|
Market
For Our Common Stock and Related Stockholder Matters
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28
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Item
6:
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Selected
Financial Data
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29
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Item
7:
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
29
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Item
7A:
|
Quantitative
Qualitative Disclosures About Market Risk
|
35
|
Item
8:
|
Financial
Statements and Supplementary Data
|
35
|
Item
9:
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
35
|
Item
9A:
|
Assessment
of the Effectiveness of Internal Controls over Financial
Reporting
|
36
|
Item
9B:
|
Other
Information
|
36
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PART
III
|
36
|
|
Item
10:
|
Directors,
Executive Officers, Corporate Governance
|
36
|
Item
11:
|
Executive
Compensation
|
36
|
Item
12:
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
36
|
Item
13:
|
Certain
Relationships and Related Transactions, and Director
Independence
|
36
|
Item
14:
|
Principal
Accountant Fees and Services
|
36
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Part
IV
|
37
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Item
15:
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Exhibits,
Financial Statements Schedules
|
42
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I
PART
1
FORWARD
LOOKING STATEMENTS
This
Annual Report on Form 10-K contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or achievements of
the Company, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. When used in this Annual Report, statements that are
not statements of current or historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, the words “plan”, “intend”, “may,”
“will,” “expect,” “believe”, “could,” “anticipate,” “estimate,” or “continue” or
similar expressions or other variations or comparable terminology are intended
to identify such forward-looking statements. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date hereof. Except as required by law, the Company undertakes no obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
Item
1: Business.
General
We are a
development stage biotechnology company with the intent to develop safe and
effective cancer vaccines that utilize multiple mechanisms of immunity. We are
developing a live Listeria vaccine technology
under license from the University of Pennsylvania (“Penn”) which secretes a
protein sequence containing a tumor-specific antigen. We believe this vaccine
technology is capable of stimulating the body’s immune system to process and
recognize the antigen as if it were foreign, generating an immune response able
to attack the cancer. We believe this to be a broadly enabling platform
technology that can be applied to the treatment of many types of cancers
infectious diseases and auto-immune disorders.
The
discoveries that underlie this innovative technology are based upon the work of
Yvonne Paterson, Ph.D., Professor of Microbiology at Penn. This technology
involves the creation of genetically engineered Listeria that stimulate the
immune system to induce antigen-specific anti-tumor immune response involving
both innate and adaptive arms of the immune system. In addition, this
technology facilitates the immune response by altering tumors to make them more
susceptible to immune attack, and increasing the number and maturation of
development of specific cells that underlie a strong therapeutic immune
response.
We have
focused our initial development efforts upon therapeutic cancer vaccines
targeting cervical cancer, its predecessor condition, CIN, Head and Neck cancer,
breast cancer, prostate cancer, and other cancers. Our lead products in
development are as follows:
Product
|
Indication
|
Stage
|
||
ADXS11-001
|
Cervical
Cancer
|
Phase I Company
sponsored & completed in 2007.
|
||
Cervical
Intraepithelial Neoplasia (CIN)
|
Phase II Company
sponsored study, commenced in March 2010 (with patient dosing commencing
in June 2010).
|
|||
Cervical
Cancer
|
Phase II Company
sponsored study initiated in November 2010 in India. 110 Patients with
advanced cervical cancer.
|
|||
Cervical
Cancer
|
Phase II The Gynecologic
Oncology Group of the National Cancer Institute has agreed to conduct a
study which we expect will commence in early 2011.
|
|||
Head
& Neck Cancer
|
Phase I The Cancer
Research UK (CRUK) is funding a study of up to 45 patients at 3 UK
facilities that we expect will commence in early 2011.
|
|||
ADXS31-142
|
Prostate
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
Breast
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
Canine
Osteosarcoma
|
Phase
1 Company sponsored (timing to be
determined).
|
We
have sustained losses from operations in each fiscal year since our inception,
and we expect these losses to continue for the indefinite future, due to the
substantial investment in research and development. As of October 31, 2010,
we had an accumulated deficit of $27,416,000 and shareholders’ deficiency of
$14,802,631.
1
To date,
we have outsourced many functions of drug development including manufacturing,
and clinical trials management. Accordingly, the expenses of these
outsourced services account for a significant amount of our accumulated
loss. We cannot predict when, if ever, any of our product candidates will
become commercially viable or approved by the FDA. We expect to spend
substantial additional sums on the continued administration and research and
development of proprietary products and technologies, including conducting
clinical trials for our product candidates, with no certainty that our products
will become commercially viable or profitable as a result of these
expenditures.
History
of the Company
We were
originally incorporated in the State of Colorado on June 5, 1987 under the name
Great Expectations, Inc. We were administratively dissolved on January 1, 1997
and reinstated June 18, 1998 under the name Great Expectations and Associates,
Inc. In 1999, we became a reporting company under the Securities Exchange
of 1934 (the “Exchange Act’). We were a publicly-traded “shell” company without
any business until November 12, 2004 when we acquired Advaxis, Inc., a Delaware
corporation, through a Share Exchange and Reorganization Agreement, dated as of
August 25, 2004 (the “Share Exchange”), by and among Advaxis, the stockholders
of Advaxis and us. As a result of such acquisition, Advaxis become our
wholly-owned subsidiary and our sole operating company. On December 23, 2004, we
amended and restated our articles of incorporation and changed our name to
Advaxis, Inc. On June 6, 2006 our shareholders approved the reincorporation of
the company from the state of Colorado to the state of Delaware by merging the
Company into its wholly-owned subsidiary. As used herein, the words
“Company” and "Advaxis" refer to the current Delaware corporation only
unless the context references such entity prior to the June 26, 2006
reincorporation into Delaware (in which case it refers to the Colorado entity).
Our principal executive offices are located at Technology Centre of NJ, 675 US
Highway One, North Brunswick, NJ 08902 and our telephone number is (732)
545-1590.
On July
28, 2005 we began trading on the Over-The-Counter Bulletin Board (OTC:BB) under
the ticker symbol ADXS.
Recent
Developments
Series B
Preferred Equity Financing
Pursuant
to the terms of the preferred stock purchase agreement dated July 19, 2010,
which we refer to as the Series B purchase agreement, with Optimus Life Sciences
Capital Partners LLC, which we refer to as Optimus, as of January 27, 2011, we
had issued and sold 422 shares of non-convertible, redeemable Series B preferred
stock, which we refer to as our Series B preferred stock, to
Optimus. The aggregate purchase price for the Series B preferred
stock was $4.22 million. Under the terms of the Series B purchase
agreement, Optimus remains obligated, from time to time until July 19, 2013, to
purchase up to an additional 328 shares of Series B preferred stock at a
purchase price of $10,000 per share upon notice from us to Optimus, and subject
to the satisfaction of certain conditions, as set forth in the Series B purchase
agreement. Among these conditions, we must have a sufficient number
of registered shares underlying a warrant issued to an affiliate of
Optimus. We currently have 4,010,038 registered shares available
under our prospectus and will likely need to register additional warrant shares
in order to require Optimus to purchase the remaining shares of Series B
preferred stock.
2
In
connection with the foregoing transaction, an affiliate of Optimus was granted
warrants to purchase 40,500,000
shares of our common stock on July
19, 2010 at an exercise price of $0.25 to be adjusted in connection with the
draw down of each tranche. As of January 27, 2011, Optimus has exercised
warrants to purchase 36,489,962 shares of common stock at adjusted exercise
prices ranging from $0.15 to $0.17 per share. As permitted by the terms of such
warrants, the aggregate exercise price of $5,697,000 received by us is payable
pursuant to four year full recourse promissory notes bearing interest at the
rate of 2% per year.
On
December 30, 2010, immediately following the issuance by us of 72 shares of
Series B preferred stock pursuant to the Series B purchase agreement, we
redeemed 226 shares of Series B preferred stock held by Optimus for an aggregate
redemption price of $3,141,004 consisting of (i) cash in an amount of $76,622
and (ii) the cancellation of certain promissory notes issued by an affiliate of
Optimus to us in the aggregate amount of $3,064,382.
Recent
Bridge Financings
From
November 1, 2010 through November 10, 2010 we issued to certain accredited
investors (i) junior unsecured convertible promissory notes in the aggregate
principal face amount of $431,579, for an aggregate net purchase price of
$410,000 and (ii) warrants to purchase 1,025,000 shares of our common stock at
an exercise price of $0.17 per share, subject to adjustments upon the occurrence
of certain events. The bridge notes were issued with an original issue discount
of 5% (OID) and are convertible into shares of our common stock. These notes
mature in 60 days from their origination. From November 1, 2010 through November
5, 2010 we also issued to certain accredited investors (i) junior unsecured
convertible promissory notes in the aggregate principal face amount of $500,000,
for an aggregate net purchase price of $425,000 and (ii) warrants to purchase
2,062,500 shares of our common stock at an exercise price of $0.17 per share,
subject to adjustments upon the occurrence of certain events. The bridge notes
were issued with an original issue discount of 15% (OID) and are convertible
into shares of our common stock. These notes mature on or before August 31,
2011. The indebtedness represented by the bridge notes is expressly subordinate
to our currently outstanding senior secured indebtedness (including the June
2009 bridge notes), as well as any future senior indebtedness of any kind. We
will not make any payments to the holders of these bridge notes until the
earlier of the repayment in full or conversion of the senior
indebtedness.
3
During
November 2010 the Company repaid four bridge notes issued
during fiscal 2010 in the
principal amounts of $187,582. With respect to all bridge notes issued
from June, 2009 through January 27, 2011, an aggregate
principal amount of $1,874,100 remain outstanding.
On January 3,
2011, we issued to a certain accredited investor, one junior unsecured
convertible promissory note in the aggregate principal face amount of $352,941,
for an aggregate net purchase price of $300,000 and (ii) warrants to purchase
1,500,000 shares of our common stock at an exercise price of $0.15 per share,
subject to adjustments upon the occurrence of certain events. The bridge notes
were issued with an original issue discount of 15% (OID) and are convertible
into shares of our common stock. These notes mature in 9 months from their
origination.
We
maintain a website at www.advaxis.com which
contains descriptions of our technology, our drugs and the trial status of each
drug.
Strategy
During
the next 24 months, we will focus on developing sufficient human clinical data
on ADXS11-001, our first Listeria construct, to
demonstrate clinical effectiveness in cervical cancer and it's medical
predecessor condition, CIN. Beyond effectiveness specifically against HPV
oncogenes, we also want to demonstrate more broadly that attenuated Listeria that secretes
an antigen adjuvant fusion protein is an effective platform for multiple
therapies against cancer and infectious disease. In the U.S., we
have initiated a single blind, placebo controlled Phase II
clinical trial of ADXS11-001 with three dosage arms in Cervical
Intraepithelial Neoplasia (cervical dysplasia, CIN), a pre cancerous
condition. In India, we have launched a 110 patient Phase II trial in advanced
cervical cancer in women who have progressed after
receiving cytotoxic therapy.
Within
the next 3 months we will initiate in the U.S. another NCI-supported study in
late stage cervical cancer , and a head and neck cancer study with
CRUK in the UK. We have signed an agreement to collaborate in a clinical trial
with the Gynecologic Oncology Group (GOG), one of NIH’s clinical
research groups, which will underwrite the cost and whose members will execute
the trial. It is expected that this US Phase II multi-center
study will result in a cost avoidance benefit to Advaxis valued at
between $7 million to $8 million in trial expenses. The CRUK initial
study should be worth between $2.5 and 3.5 million.
The
Company has entered into a clinical trials agreement with the School of
Veterinary Medicine at Penn to investigate the use of its compound ADXS31-164
for the treatment of osteosarcoma in dogs. This disease is the leading
cancer killer of large dogs and is a model for the treatment of human
osteosarcoma, the leading fatal bone cancer in adolescents.
We have
also initiated the production of human grade production of two new vaccines for
which we expect to begin clinical development in 2011. Planning has begun
for Phase I trials for ADXS31-142 for the treatment of prostate cancer, and
ADXS 31-164 for the treatment of breast, brain and other
cancers.
4
Although
the company has been successful in obtaining clinical funding from the U.S. and
UK, in order to implement our strategy, we will require substantial additional
investment in the near future. Our failure to raise capital or pursue partnering
opportunities will materially and adversely affect both our ability to commence
or continue the clinical trials described above and our business, financial
condition and results of operations, and could force us to significantly curtail
or cease operations. Further, we will not have sufficient resources to develop
fully any new products or technologies unless we are able to raise substantial
additional financing over and above the preferred stock financing on acceptable
terms or secure funds from new partners.
Given our
expertise to genetically modify Listeria to create vaccines
for many different diseases, our longer term strategy will be to license the
commercial development of ADXS11-001 for the indications of CIN, cervical and
head and neck cancers, and other HPV related diseases. On a global basis, these
indications are extremely large and will require one or more significant
partners. We do not intend to engage in commercial development beyond Phase II
without entering into one or more partnerships or a license
agreement.
We intend
to continue to devote a substantial portion of our resources to basic science
and the continued pre-clinical development and optimization of our technology so
as to develop it to its full potential and to find additional new drug
candidates. These activities may require significant financial resources, as
well as areas of expertise beyond those readily available. In order to provide
additional resources and capital, we may enter into research, collaborative or
commercial partnerships, joint ventures, or other arrangements with competitive
or complementary companies, including major international pharmaceutical
companies or universities.
Background
Cancer
Cancer is
the second largest cause of death in the U.S., exceeded only by heart disease.
The cost of treating cancer patients in 2008 was estimated to be $228.1 billion
in healthcare costs and another $188 billion in indirect costs resulting from
morbidity and lost productivity (source: Facts & Figures 2009, American
Cancer Society). The American Cancer Society’s most recent estimates for newly
diagnosed cervical cancer in the U.S. in 2010 was 12,200 and numbers for newly
diagnosed CIN are approximately about 250,000 patients per year based on 3.5
million abnormal Pap smears (source: Jones HW, Cancer 1995:76:1914-18; Jones BA
and Davey, Arch Pathol Lab Med 2000; 124:672-81). Overall predicted incidence
and mortality rates for 2009 are set forth below
Percent
of U.S. deaths due to cancer in 2006
5
Immune
System and Normal Antigen Processing
People,
are continually confronted with potentially infectious agents. The immune system
has evolved multiple mechanisms to fight disease, including including innate
immunity, two forms of adaptive immunity humoral (antibody), and cellular
immunity that mobilize the body’s natural defenses against these foreign agents
to eliminate them.
Innate
Immunity:
Innate
immunity is the first step in the recognition of a foreign antigen. It is
a non-specific protective response that also underlies the generation of an
adaptive (antigen- specific) immune responses. It is characterized by the
release of various soluble mediators of immune response such as cytokines,
chemokines and other molecules.
Exogenous pathway of
Adaptive Immunity (Class II pathway):
Proteins
and foreign molecules ingested by Antigen Presenting Cells, or APCs, are broken
down inside digestive vacuoles into small pieces, and the pieces are combined
with proteins called Class 2 MHC (for Major Histocompatibility Complex) in a
part of the cell called the endoplasmic reticulum. The MHC-peptide, termed
and MHC-2 complex from the Class 2 (or exogenous) pathway, migrates to the cell
surface where it interacts with certain classes of lymphocytes (CD4+) called
helper T-cells that support the function of cytotoxic T-lymphocytes (killer T
cells). This interaction renders CD4+ cells
antigen specific, and they express their function whenever they encounter the
antigen to which they’ve been activated. This system is called the
exogenous pathway, since it is the prototypical response to an antigen from
outside of the cell, like bacteria.
Endogenous pathway of
Adaptive Immunity (Class I pathway):
The
endogenous pathway provides immune protection against antigens created within
the cytoplasm of the APC (as opposed exogenous molecules contained within he
digestive phagosome). These intracellular antigens are typically broken
down by within the cell and directed to the endoplasmic reticulum, where they
are incorporated into an MHC-1 protein and trafficked to the cell surface.
MHC-1 complexes activate CD8+ cytotoxic T-lymphocytes, which then kill cells
that express the specific antigen to which these cells are now activated.
The endogenous pathway is needed for elimination of virus-infected or cancerous
cells.
Listeria generated adaptive
immune responses are directed at the activation of T cells. Listeria tends not to
stimulate antibody formation.
6
Listeria based vaccines are
unique for many reasons, one of which is that unlike viral vectors, DNA or
peptide antigens or other vaccines, Listeria stimulates all of
the above mechanisms of immune action. We use a bioengineered form of Listeria to activate the
immune system to treat cancer, infectious diseases, or allergic syndromes.
Our technology allows the body to recognize tumor-associated or tumor-specific
antigens as foreign, thus creating the immune response needed to attack the
cancer. It does this by utilizing a number of biological characteristics
of the Listeria
bacteria and Advaxis proprietary antigen-fusion protein technology to stimulate
multiple therapeutic immune mechanisms simultaneously in an integrated and
coordinated manner.
Mechanism
of Action
Listeria monocytogenes (Lm) is a bacterium well
known to medical science because it can cause an infection in humans.
Listeria is a
rare, but serious, cause food poisoning, typically in the very old, the very
young, people who are either immunocompromised or who eat a large quantity of
the microbe as can occur in spoiled food. It is not laterally transmitted
from person to person. As Lm is in the soil and thus
found on leafy vegetables, in meat and dairy products, and is a common microbe
in our environment , we are exposed to it constantly. Most people ingest
Listeria without being
aware of it, but in high quantities or in immune suppressed people Listeria can cause various
clinical conditions, including sepsis, meningitis and placental infections in
pregnant women. This is rare, and fortunately, many common antibiotics can
kill and sterilize Listeria. Advaxis has a
number of strains of Listeira that are bioengineered for use as a human vaccine
vector. These vaccines are highly attenuated, which means they are much
less pathogenic. Advaxis vaccines are between 10,000 and 100,000 times
weaker (and less able to cause disease) than wild type Listeria.
Live
Listeria is one of the
strongest known stimulators of the innate immune system, thereby priming the
adaptive immune system to better respond to the specific antigens that the Listeria carries, which
viruses and other vectors do not do. This is a non-specific stimulation of
the overall immune system that results when certain classes of pathogens such as
bacteria are detected. It provides some level of immune protection and
also serves to prime the elements of adaptive immunity to respond in a stronger
way to the specific antigenic stimulus. Listeria stimulates a strong
innate response which engenders a strong adaptive response.
APCs are
scavenging cells in the body that circulate looking for foreign invaders.
When they find one, they ingest it, break it down, and provide the fragments as
molecular targets for the immune system to attack. In this way, they
are the cells that direct a specific immune response, and Listeria has the ability to
infect them. Because Listeria infects APC, and our
vaccines secrete biologically active molecules from within APC, our live
attenuated Lm vaccines
have the ability to direct an immune attack in a way no other therapy
can.
When
Listeria enters the
body, it is seen as foreign by the antigen presenting cells and ingested into
cellular compartments called phagolysosomes, whose destructive enzymes kill most
of the bacteria. A certain percentage of these bacteria, however, are able to
break out of the phagolysosomes and enter into the cytoplasm of the cell, where
they are relatively safe from the immune system. The bacteria multiply in
the cell, and the Listeria is able to move to
its cell surface so it can push into neighboring cells and
spread.
7
Figs 1-7.
When Listeria enters
the body, it is seen as foreign by the antigen presenting cells and ingested
into cellular compartments called phagolysosomes, whose destructive enzymes kill
most of the bacteria, fragments of which are then presented to the immune system
via the exogenous pathway.
Figs 8-10
A certain percentage of bacteria is able to break out of the lysosomes and enter
into the cytoplasm of the cell, where they are safe from lysosomal destruction.
The bacteria multiply in the cell, and the Listeria is able to migrate
into neighboring cells and spread without entering the extracellular space.
Antigens produced by these bacteria enter the Class I pathway and directly
stimulate a cytotoxic T cell response.
It is the
details of Listeria
intracellular activity that are important for understanding Advaxis technology.
Inside the lysosome, Listeria produces
listeriolysin-O (“LLO”), a protein that creates a hole in the membrane of the
lysosome that allows the bacteria to escape into the cytoplasm. Once in the
cytoplasm, however, LLO is also capable of creating a hole in the outer cell
membrane. This would destroy the host cell. To prevent this, the body has
evolved a mechanism for recognizing enzymes with this capability based upon
their amino acid sequence. The sequence of approximately 30 amino acids in LLO
and similar molecules is called the PEST sequence (for the predominant amino
acids it contains). When a PEST sequence is detected it is used by normal
cells to force the termination of proteins that need only have a short life in
the cytoplasm. This PEST sequence serves as a routing tag that tells the cells
to route the LLO in the cytoplasm to the proteosome for digestion, which
terminates its action and provides fragments that then go to the endoplasmic
reticulum, where it is processed just like a protein antigen in the endogenous
pathway to generate MHC-1 complexes.
This
mechanism is used by Listeria, to its benefit,
because the actions of LLO enable the bacteria to avoid digestion in the
lysosome and escape to the cytosol where they can multiply and spread and then
be neutralized so that it does not kill the host cell. Advaxis is using a
technology that co-opts this mechanism by creating a protein that is comprised
of the cancer antigen fused to a non-hemolytic portion of the LLO molecule that
contains the PEST sequence. This serves to route the molecule for accelerated
proteolytic degradation which accelerates both the rate of antigen breakdown and
the amount of antigen fragments available for incorporation in to MHC-1
complexes; thus increasing the stimulus to activate cytotoxic T cells against a
tumor-specific antigen. Moreover, LLO is a very strong adjuvant, which
means it is a strong stimulator of innate immunity.
8
Other
mechanisms that Advaxis vaccines employ include Listeria’s ability to
increase the synthesis of myeloid cells such as Antigen Presenting Cells (“APC”)
and macrophages, and to stimulate the maturation of immature myeloid cells to
increase the number of available activated immune cells that underlie a cancer-
killing response. Immature myeloid cells actually inhibit the immune system and
Listeria removes this
inhibition within the actual tumor. Also, Listeria and LLO both
stimulate the synthesis, release, and expression of various chemicals which
stimulate a therapeutic immune response. These chemicals are called cytokines,
chemokines and co-stimulatory molecules. By doing this, not only are immune
cells activated to kill cancers and clear them from the body, but local
environments within tumors are created that support and facilitate a therapeutic
response.
Finally,
in a manner that appears to be unique to Advaxis live attenuated Listeria vaccines: they can
reduce the number and function of immunosuppressive cells that tumors recruit to
protect them from therapeutic immune attack. Over the past few years it
has become known that the reason many previous immunologic cancer treatments
have failed is that although they were able to strongly activate the immune
system, they were rendered ineffective by endogenous sources of immune
inhibition within the tumors themselves. Advaxis has either published
scientific papers or presented data at scientific meetings about the ability of
our vaccines to reduce the number of regulatory T cells (Tregs) and Myeloid
Derived Suppressor Cells (MDSC); and that MDSC which remain are less
immunosuppressive. This renders tumors susceptible to immune attack. The
ability to reduce the effect of immunosuppressive cells within tumors is
currently under clinical investigation by other companies and is believed to be
a significant mechanism of achieving a therapeutic response.
Advaxis
live attenuated Listeria vaccines also have
the ability to modify the function of vascular endothelial cells in a way that
facilitates the trafficking of activated immune cells out of the blood and into
the tumor, where they are therapeutically effective. One property of
cancer is the modification of vascular cells to prevent activated immune cells
from transiting into the tumor. Our vaccines appear to overcome this
source of anti-tumor inhibition.
Many of
the immune effector cells, such as dendritic cells, macrophages, mast cells,
Langerhans cells and others are myeloid cells. Our vaccines have the
ability to accelerate the synthesis and maturation of these cells, as well as
their antigen specific activation, to increase the power and efficiency of the
immune response.
It should
also be noted that the live Listeria vaccines Advaxis
creates are attenuated from 10,000 to 100,000 times in order that they will not
cause disease themselves. The strains of Listeria that we use are
cleared by animals such as SCID mice or IFN-gamma knockout mice that lack
adaptive immune responses and are thus profoundly
immuno-compromised.
Thus,
Listeria vaccines
stimulate every immune pathway simultaneously, and in an integrated
manner. It has long been recognized that cytotoxic T lymphocytes, or CTL,
are the elements of the immune system that kill and clear cancer cells.
The amplified CTL response to Listeria vaccines are one of
the strongest stimulators of CTL yet developed, but just as important is the
ability Advaxis vaccines have to create a local tumor environment in which these
cells can be effective. This efficacy likely results in part from the
fusion of LLO to the secreted tumor antigen since many investigators have shown
that LLO is a very strong source of immune stimulation independent of Listeria. By fusing a
molecule with strong adjuvant properties to a tumor antigen, and then having it
synthesized and secreted by live bacteria directly into the cytoplasm of Antigen
Presenting Cells, vascular endothelium and other relevant tissues an unusually
powerful and complete immune response is generated.
9
Recently
we have shown that Lm
-LLO vaccines can cause epitope spreading. This means that these vaccines
can stimulate the immune system to respond to more antigens than the one they
are designed to attack. This happens when tumor cells are killed by the
immune system in response to the administered vaccine and portions of those
killed cells are then recognized by the immune system and they too become
targets of an immune attack. This broadens the immune attack and results
in a more therapeutic response.
Thus,
what makes Advaxis live Listeria vaccines so effective are a combination of
effects that stimulate multiple arms of the immune system simultaneously in a
manner that generates an integrated physiologic response conducive to the
killing and clearing of tumor cells. These mechanisms
include:
|
1.
|
One
of the strongest known stimulators of innate
immunity
|
|
a.
|
Lm-LLO
vaccines are cleared in SCID mice by innate immunity
alone
|
|
2.
|
Stimulate
a very strong adaptive immune
response
|
|
a.
|
High
titers of activated CD4+, CD8+, APC, and
TIL
|
|
3.
|
Alters
Tumor Microenvironment
|
|
a.
|
Reduces
both Tregs, MDSC & TAM in tumors but not in surrounding
tissue
|
|
4.
|
Stimulate
synthesis of new immune cells and maturation of existing
cells
|
|
a.
|
Marrow,
tissue and blood born effects
|
|
5.
|
Stimulates
chemotaxis and extravasation of activated immune
cells
|
|
a.
|
Chemokine
mediated effects and effects directly on vascular endothelium increase
TIL
|
|
6.
|
Lm
infects tumors with Intra-tumoral
effects
|
|
a.
|
Tumor
killing, chemotaxic focus, & local innate immune
effects
|
|
7.
|
Initiates
epitope spreading
|
|
a.
|
Vaccines
directed against one antigen result in immune activation against other
antigens
|
Importantly,
Advaxis live attenuated Listeria vaccines do not stimulate antibody formation,
which is important because other types of cancer vaccines such as those that use
viruses develop antibody responses which inactivate them and prevent them being
used repetitively in a vaccine regimen. These types of vaccines are
inactivated by antibody responses before they can effectively deliver their
immune payload which revents them from stimulating a therapeutic response.
Advaxis vaccines can be used effectively in a multidose vaccine regimen as they
are not inactivated by antibody responses.
Research
and Development Program
Overview
We use
genetically engineered and highly attenuated Listeria monocytogenes as a
therapeutic agent. We start with an attenuated strain of Listeria, and then
add to this bacterium multiple copies of a plasmid that encodes a fusion protein
sequence that includes a fragment of the LLO molecule joined to the tumor
antigen of interest. This protein is secreted by the Listeria inside the antigen
presenting cells, and other cells that Listeria infects which then
results in the immune response as discussed above.
We can
use different tumor, infectious disease, or other antigens in this system. By
varying the antigen, we create different therapeutic agents. Our lead agent,
ADX11-001uses a HPV derived antigen that is present in cervical cancers.
ADXS31-162 uses Her2/neu, an antigen found in many breast cancer and melanoma
cells, to induce an immune response that should be useful in treating these
conditions. ADXS31-142 is directed against PSA, and antigen of importance
in prostate cancer.
Partnerships
and Agreements
University
of Pennsylvania
On July
1, 2002 we entered into a 20-year exclusive worldwide license with Penn, with
respect to the innovative work of Yvonne Paterson, Ph.D., Professor of
Microbiology in the area of innate immunity, or the immune response attributed
to immune cells, including dendritic cells, macrophages and natural killer cells
that respond to pathogens non-specifically. This agreement has been
amended from time to time and has been amended and restated as of February
13, 2007.
10
This
license, unless sooner terminated in accordance with its terms, terminates upon
the later (a) expiration of the last to expire Penn patent rights; or (b) twenty
years after the effective date of the license. The license provides us
with the exclusive commercial rights to the patent portfolio developed at Penn
as of the effective date of the license, in connection with Dr. Paterson and
requires us to raise capital and pay various milestone, legal, filing and
licensing payments to commercialize the technology. In exchange for the
license, Penn received shares of our common stock which currently represents
approximately 0.2% of our common stock outstanding on a fully-diluted
basis. In addition, Penn is entitled to receive a non-refundable initial
license fee, license fees, royalty payments and milestone payments based on net
sales and percentages of sublicense fees and certain commercial
milestones. Under the licensing agreement, Penn is entitled to receive
1.5% royalties on net sales in all countries. Notwithstanding these
royalty rates, we have agreed to pay Penn a total of $525,000 over a three-year
period as an advance minimum royalty after the first commercial sale of a
product under each license (which we are not expecting to begin paying within
the next five years). In addition, under the license, we are obligated to
pay an annual maintenance fee of $100,000 on December 31, 2010, 2011 and 2012
and each December 31st thereafter for the remainder of the term of the agreement
until the first commercial sale of a Penn licensed product. Overall the
amended and restated agreement payment terms reflect lower near term
requirements but the savings are offset by higher long term milestone payments
for the initiation of a Phase III clinical trial and the regulatory approval for
the first Penn licensed product. We are responsible for filing new patents
and maintaining and defending the existing patents licensed to use and we are
obligated to reimburse Penn for all attorneys fees, expenses, official fees and
other charges incurred in the preparation, prosecution and maintenance of the
patents licensed from Penn.
Furthermore,
upon the achievement of the first sale of a product in certain fields, Penn will
be entitled to certain milestone payments, as follows: $2.5 million will be due
for first commercial sale of the first product in the cancer field. In
addition, $1.0 million will be due upon the date of first commercial sale of a
product in each of the secondary strategic fields sold.
As a
result of our payment obligations under the license, assuming we have net sales
in the aggregate amount of $100.0 million from our cancer products, our total
payments to Penn over the next ten years could reach an aggregate of $5.4
million. If over the next 10 years our net sales total an aggregate amount
of only $10.0 million from our cancer products, total payments to Penn could be
$4.4 million.
On May
10, 2010, we entered into a second amendment to the Penn license agreement
pursuant to which we acquired exclusive licenses for an additional 27 patent
applications related to our proprietary Listeria vaccine
technology. As per the terms of the second amendment, we acknowledged that
we owed Penn approximately $249,000 in patent expenses and $130,000 in sponsored
research agreement fees; such
fees being paid prior to October 31, 2010. As part of this
amendment we exercised our option for the rights to seven additional patent
dockets,
including 23 additional patent applications, at an
option exercise fee payable in the form of $35,000 in cash and $70,000 in our
common stock (approximately 388,889 shares of our common stock based on a price
of $0.18 per share) and at a
cost of approximately $462,000. As of
January 27, 2011, the Company had paid $250,000
and $212,000 remained outstanding.
Strategically
we intend to maintain our relationship with Dr. Paterson and Penn to generate
new intellectual property and to exploit all existing intellectual property
covered by the license.
Penn is
not involved in the management of our company or in our decisions with respect
to exploitation of the patent portfolio, except that Dr. Paterson is the
Chairperson of our Scientific Advisory Board.
Dr.
Yvonne Paterson
Dr.
Paterson is a Professor in the Department of Microbiology at Penn and the
inventor of our licensed technology. She is a fellow of the American
Academy for the Advancement of Science, and has been an invited speaker at
national and international health field conferences and leading academic
institutions. She has served on many federal advisory boards, such as the
NIH expert panel to review primate centers, the Office of AIDS Research Planning
Fiscal Workshop, and the Allergy and Immunology NIH Study Section. She has
written over one hundred publications in immunology with emphasis during the
last several years on the areas of HIV, AIDS and cancer research. She has
trained over forty post-doctoral and doctoral students in the fields of
Biochemistry and Immunology. Dr. Paterson is also the Chairman of our
Scientific Advisory Board.
Consulting Agreement.
On January 28, 2005 we entered into a consulting agreement with Dr. Paterson,
which expired on January 31, 2009. Dr. Paterson has advised us on
an exclusive basis on various issues related to our technology, manufacturing
issues, establishing our lab, knowledge transfer, and our long-term research and
development program. Pursuant to the expired agreement, Dr. Paterson
received $7,000 per month. Upon the closing of an additional $9.0 million
in equity capital, Dr. Paterson’s rates would have increased to $9,000 per
month. Also, under the prior Agreement, on February 1, 2005, she received
options to purchase 400,000 shares of our common stock at an exercise price of
$0.287 per share which are now fully vested. In total she holds 704,365
shares of our common stock and 569,048 fully vested options to purchase shares
of our common stock.
We
believe that Dr. Paterson’s continuing research will serve as a source of
ongoing findings and data that both supports and strengthens the existing
patents. We further believe that her work will expand the claims of the
patent portfolio (potentially including adding claims for new tumor specific
antigens, the utilization of new vectors to deliver antigens, and applying the
technology to new disease conditions) and create the infrastructure for the
future filing of new patents.
11
Cancer
Research UK
On February 9, 2010, we announced that
Cancer Research UK (CRUK), the UK organization dedicated to cancer research, has
agreed to fund the cost of a clinical trial to investigate the use of
ADXS11-001, our lead vaccine candidate, for the treatment of head and neck
cancer. This sponsored clinical trial will investigate the safety and efficacy
of ADXS11-001 in head and neck cancer patients who have previously failed
treatment with surgery, radiotherapy and chemotherapy – alone or in combination.
We will provide the vaccines, with all other associated costs to be funded by
CRUK. The study is to be conducted at Aintree Hospital at the University of
Liverpool, The Royal Marsden Hospital in London, and Cardiff Hospital at the
University of Wales. At such time, enrollment officials anticipate recruiting a
maximum of 45 patients.
National Cancer Institute
Gynecologic Oncology Group
On December 15, 2009, we announced our
Phase II Trial Collaboration with the National Cancer Institute Gynecologic
Oncology Group to study ADXS11-001 in a study of up to 63 patients. We will
collaborate in a multicenter, Phase II clinical trial of our lead drug
candidate, ADXS11-001, in the treatment of advanced cervix cancer in women who
have failed prior cytotoxic therapy. This Phase II trial is underwritten by GOG
and will be conducted by GOG investigators. The study’s patients are very sick
and rapidly progressing similar to the population that was treated in our Phase
I trial of ADXS11-001. Under this agreement we are responsible for covering the
costs of translational research and have agreed to pay a total of $8,003 per
patient, with the bulk of the costs of this study underwritten by
NCI.
On
November 1, 2010 the Vaccine Section of National Cancer Institute and Advaxis
have entered into a Collaborative Research and Development Agreement (CRADA) for
the development of live attenuated Listeria vaccines for
the treatment of cancer. Advaxis will provide all live Listeria vaccines. NCI
will use different in
vitro and in
vivo models to elucidate the effect of Advaxis live attenuated Listeria vaccines on
many different types of immune cells, and will investigate the mechanisms by
which live Listeria vaccines reduce
cancer induced immune inhibition that protects tumors from immune attack.
Advaxis and NCI will use the results of this work to enhance the anti-tumor
effects of live Listeria
vaccines as therapeutic agents for the treatment of cancer and as
therapeutic immune adjuvants that alter the tumor milieu which will enable
them to be used with other modalities of cancer treatment. The cost of the CRADA
is $150,000 annually and the length of the agreement is three
years.
University
of British Columbia (UBC)
Advaxis
entered into a structured collaboration with the laboratory of Dr. Tobias
Kollmann at the University of British Columbia (UBC) to develop live attenuated
Listeria vaccines for
the treatment of infectious disease and to develop new dosage forms of Listeria vaccines. The
same immune-stimulating properties that are under development at Advaxis to
develop live Listeria
vaccines as safe and effective therapies for the treatment of cancer, also may
have application for the treatment of infectious disease. Dr. Kollmann is an
immunologist and neonatal vaccinologist who has published extensively on the use
of Listeria vaccines as
potential therapeutic agents for the treatment of childhood diseases.
Under the terms of this collaboration, Dr. Kollmann will use Advaxis’
proprietary Listeria
vaccine vectors for the development of novel infectious disease
applications.
The
Sage Group
We are
party to a consulting agreement with The Sage Group, a health-care strategy
consultant assisting us with a program to commercialize our vaccines. The
initial agreement was entered into in January 2009 and subsequently amended on
July 22, 2009. Pursuant to the terms of agreement, as amended, we have
agreed to pay Sage (i) $5,000 per month (which we began paying in January 2009)
until an aggregate of $120,000 has been paid to Sage under the consulting
agreement and (ii) a 5% commission for certain transactions if completed in the
first 24 months of the term of the agreement, reduced to 2% if completed in the
12 months thereafter. The Sage Group has been paid $35,000 through October 31,
2010.
Recipharm
AB (formerly Cobra Biomanufacturing PLC)
In July
2003, we entered into an agreement with Cobra Biomanufacturing PLC, which has
recently been purchased by Recipharm AB, for the purpose of manufacturing
our cervical cancer vaccine ADXS11-001. Recipharm has extensive experience
in manufacturing gene therapy products for investigational studies.
Recipharm is a manufacturing organization that manufactures and supplies
biologic therapeutics for the pharmaceutical and biotech industry. These
services include the Good Manufacturing Practices, or GMP, manufacturing of DNA,
recombinant protein, viruses, mammalian cell products and cell banking.
Recipharm’s manufacturing plan for us involves several manufacturing stages,
including process development, manufacturing of non-GMP material for toxicology
studies and manufacturing of GMP material for the Phase I trial. The
agreement to manufacture expired in December 2005 upon the delivery and
completion of stability testing of the GMP material for the Phase I trial.
Recipharm has agreed to surrender the right to $300,000 of its outstanding fees
for manufacturing in exchange for future royalties from the sales of ADXS11-001
at the rate of 1.5% of net sales, with royalty payments not to exceed $2.0
million.
On
October 20, 2007, we entered into a production agreement with Cobra to
manufacture our Phase II clinical materials using a new methodology now required
by the UK, and likely to be required by other regulatory bodies in the
future. Currently the company has two agreements with Recipharm-Cobra; one
to conduct ongoing stability testing of the ADXS11-001 vaccine which they have
manufactured, and another to provide analytic services and certification
necessary to import ADXS11-001 for use in the UK head and neck study mentioned
above. For the year ending October 31, 2010, the company paid Cobra
approximately $33k under the agreement.
Vibalogics
GmbH
In April
of 2008, we entered into a series of agreements with Vibalogics GmbH in Cuxhaven
Germany to provide fill and finish services for our final clinical materials
that were made for the scheduled clinical trials described above. These
agreements cover the fill and finish operations as well as specific tests that
have to be performed in order to release the clinical materials for human
use. Advaxis has recently entered into agreements with Vibalogics to
produce two new vaccines, ADXS31-142 and ADXS31-164 for human use and clinical
development.
12
Numoda
Corporation
On June
19, 2009, we entered into a Master Agreement and on July 8, 2009 we entered into
a Project Agreement with Numoda, a leading clinical trial and logistics
management company, to oversee Phase II clinical activity with ADXS11-001 for
the multicenter Phase II U.S. trial of ADXS11-001 in CIN and to act as our U.S.
CRO for the multicenter phase 2 study of ADXS11-001 in progressive cervix cancer
being co inducted in India. The scope of this agreement covers over
three years and is estimated to cost $11.2 million for both trials. In May
2010, we issued 3,500,000 shares of common stock to Numoda Capital at a price
per share of $0.17 in satisfaction of $595,000 of services rendered to us by the
Numoda Corporation. During the year ending October 31, 2010, the company
paid Numoda approximately $3.2 million for clinical trial
activities.
Pharm-Olam
International Ltd. (“POI”)
In April
2005, we entered into a consulting agreement with POI, whereby POI is to execute
and manage our Phase I clinical trial in ADXS11-001 for a fee of $430,000 plus
reimbursement of certain expenses. As of October 31, 2010 the Company has an
outstanding balance due to POI of $223,619.
Patents
and Licenses
Dr.
Paterson and Penn have invested significant resources and time in developing a
broad base of intellectual property around the cancer vaccine platform
technology to which on July 1, 2002 we entered into a 20-year exclusive
worldwide license and a right to grant sublicenses pursuant to our license
agreement with Penn. As of October 31, 2010 Penn has 32 issued and 33
pending patents in the U.S. and other large countries including Japan, and the
European Union, through the Patent Cooperation Treaty system pursuant to which
we have an exclusive license to exploit the patents. This follows and
agreement dated May 10, 2010, in which we entered into a second amendment to the
20-year exclusive worldwide license agreement with Penn, which we refer to as
the Second Amendment Agreement. Pursuant to the Second Amendment Agreement, we
acquired exclusive licenses for additional patent applications
related to our proprietary Listeria vaccine technology
that were not included in the initial agreement. As of January 27, 2011,
we acknowledged that we owe Penn approximately $212,000 in patent expenses
pursuant to the Second Amendment Agreement.
Our
approach to the intellectual property portfolio is to create significant
offensive and defensive patent protection for every product and technology
platform that we develop. We work closely with our patent counsel to
maintain a coherent and aggressive strategic approach to building our patent
portfolio with an emphasis in the field of cancer vaccines.
We are
aware of a private company, Anza Therapeutics, Inc (formerly Cerus Corporation),
which, is no longer in existence, but had been developing Listeria vaccines. We
are also aware of Aduro Biotech, a company comprised in part of former Cerus and
Anza employees that has recently formed to investigate Listeria vaccines based upon
Anza’s technology. We believe that through our exclusive license with
Penn, we have the earliest known and dominant patent position in the U.S.
for the use of recombinant Listeria monocytogenes
expressing proteins or tumor antigens as a vaccine for the treatment of
infectious diseases and tumors. We successfully defended our intellectual
property by contesting a challenge made by Anza to our patent position in Europe
on a claim not available in the U.S. The European Patent Office ( EPO)
Board of Appeals in Munich, Germany has ruled in favor of The Trustees of Penn
and its exclusive licensee Advaxis and reversed a patent ruling that revoked a
technology patent that had resulted from an opposition filed by Anza. The
ruling of the EPO Board of Appeals is final and cannot be appealed. The
granted claims, the subject matter of which was discovered by Dr. Yvonne
Paterson, scientific founder of Advaxis, are directed to the method of
preparation and composition of matter of recombinant bacteria expressing tumor
antigens for treatment of patients with cancer.
Based on
searches of publicly available databases, we do not believe that Anza, Aduro or
any other third party owns any published Listeria patents or has any
issued patent claims that might materially and adversely affect our ability to
operate our business as currently contemplated in the field of recombinant Listeria monocytogenes.
Additionally, our proprietary position that is the issued patents and licenses
for pending applications restricts anyone from using plasmid based Listeria constructs, or those
that are bioengineered to deliver antigens fused to LLO, ActA, or fragments of
LLO or ActA.
On
January 7, 2009, we made the decision to discontinue our use of the Trademark
Lovaxin and write-off of our intangible assets for trademarks resulting in an
asset impairment of $91,453 as of October 31, 2008. We developed a classic
coding system for our constructs. The rationale for this decision stemmed
from several legal challenges to the Lovaxin name over the last two years and
certain rules in Title 21 of the Code of Federal Regulations, which we refer to
as the CFR, which do not allow companies to use names that are assigned to drugs
in development after marketing approval. We will therefore focus company
resources on product development and not the defense of the Lovaxin
name.
On May
26, 2009, the United States Patent and Trademark Office, which we refer to as
the PTO, approved our patent application “ Compositions and Methods for
Enhancing the Immunogenicity of Antigencs ”. This patent application
covers the use of Listeria monocytogenes protein ActA
and fragments of this protein for use in the creation of antigen fusion
proteins. This intellectual property protects a unique strain of Listeria monocytogenes for use as a
vaccine vector.
13
On
February 10, 2009 the PTO issued patent 7,488,487 “ Methods of Inducing Immune response
Through the Administration of Auxotrophic Attenuated DAT/DAL Double Mutant
Listeria Strains ”, assigned to Penn and licensed to us. This
intellectual property protects a unique strain of Listeria monocytogenes for use as a
vaccine vector. This new strain of Listeria is an improvement
over the strain currently in clinical testing as it is more attenuated, more
immunogenic, and does not have an antibiotic resistance gene inserted. We
believe that this technology will make our product more effective and easier to
obtain FDA regulatory approval.
Between
February and December of 2009 the U.S., Japanese, and European patent offices
have approved patents for a newly developed strain of Listeria that uses a novel
method of attenuation. This strain is attenuated by deleting genes that
are responsible for making a protein that is essential for the bacterial cell
wall, and by engineering back the ability to make this protein at a reduced
level. In developing this strain, the objective was to improve upon the
useful properties of Listeria while reducing
potential disease causing properties of the bacterium, and in preliminary
testing this strain of Listeria monocytogenes, which
we refer to as Lm ,
appears to be more immunogenic and less virulent that prior vaccine
strains.
Between
January and March of 2010, the USPTO issued two patents to Penn (each of which
are covered by the Penn license agreement) that cover the composition of matter,
uses and methods using the Lm protein Act A in antigen
fusion proteins. We are currently holding patents relating to two families
of antigen-adjuvant fusion proteins; one based on LLO and one based on
ActA.
Governmental
Regulation
The Drug
Development Process
The FDA
requires that pharmaceutical and certain other therapeutic products undergo
significant clinical experimentation and clinical testing prior to their
marketing or introduction to the general public. Clinical testing, known
as clinical trials or clinical studies, is either conducted internally by
pharmaceutical or biotechnology companies or is conducted on behalf of these
companies by Clinical Research Organizations (CRO).
The process of conducting clinical studies is
highly regulated by the FDA, as well as by other governmental and professional
bodies. Below, we describe the principal framework in which clinical
studies are conducted, as well as describe a number of the parties involved in
these studies. Protocols . Before commencing human clinical studies,
the sponsor of a new drug must typically receive governmental and institutional
approval. In the U.S., Federal approval is obtained by submitting an IND
to the FDA and amending it for each new proposed study. The clinical research
plan is known in the industry as a protocol . A protocol is the blueprint
for each drug study. The protocol sets forth, among other things, the
following:
·
|
Criteria
for participant inclusion/ exclusion;
|
||
|
·
|
Dosing
requirements and timing;
|
|
|
·
|
Tests
to be performed; and
|
|
|
·
|
Evaluations
and data assessment.
|
Institutional Review Board (Ethics
Committee). An institutional review board is an independent
committee of professionals and lay persons which reviews clinical research
studies involving human beings and is required to adhere to guidelines issued by
the FDA. The institutional review board does not report to the FDA and its
members are not appointed by the FDA, but its records are audited by the
FDA. All clinical studies must be approved by an institutional review
board. The institutional review board is convened by the institution where
the protocol will be conducted and its role is to protect the rights of the
participants in the clinical studies. It must approve the protocols to be
used, and then oversees the conduct of the study, including oversight
of the communications which we or the CRO conducting the study at that
specific site proposes to use to recruit participants, and the form of consent
which the participants will be required to sign prior to their participation in
the clinical studies.
Clinical Trials. Human
clinical studies or testing of a potential product prior to Federal approval are
generally done in three stages known as Phase I, Phase II, and Phase III
testing. The names of the phases are derived from the CFR 21 that
regulates the FDA. Generally, there are multiple studies conducted in each
phase.
Phase I. Phase I
studies involve testing a drug or product on a limited number of
participants. Phase I studies determine a drug’s basic safety and how the
drug is absorbed by, and eliminated from, the body. This phase lasts an
average of six months to a year. Typically, cancer therapies are initially
tested on late stage cancer patients.
Phase II. Phase II
trials involve larger numbers of participants at a time who suffer from the
targeted disease or condition. Phase II testing typically lasts an average
of one to three years. In Phase II, the drug is tested to determine its
safety and effectiveness for treating a specific illness or condition.
Phase II testing also involves determining acceptable dosage levels of the
drug. If Phase II studies show that a new drug has an acceptable range of
safety risks and probable effectiveness, a company will continue to review the
drug in Phase III studies.
14
Phase III. Phase III
studies involve testing even larger numbers of participants, typically several
hundred to several thousand persons. The purpose is to verify
effectiveness and long-term safety on a large scale. These studies
generally last two to six years. Phase III studies are conducted at
multiple locations or sites. Like the other phases, Phase III requires the
site to keep detailed records of data collected and procedures
performed.
Biologic License Application
(BLA). The results of the clinical trials using biologics are
submitted to the FDA as part of BLA. Following the completion of Phase III
studies, if the sponsor of a potential product in the U.S. believes it has
sufficient information to support the safety and effectiveness of their product,
the sponsor submits a BLA to the FDA requesting that the product be approved for
sale. The application is a comprehensive, multi-volume filing that
includes the results of all preclinical and clinical studies, information about
the drug’s composition, and the sponsor’s plans for producing, packaging,
labeling and testing the product. The FDA’s review of an application can
take a few months to many years, with the average review lasting 18
months. Once approved, drugs and other products may be marketed in the
U.S., subject to any conditions imposed by the FDA.
The drug
approval process is time-consuming, involves substantial expenditures of
resources, and depends upon a number of factors, including the severity of the
illness in question, the availability of alternative treatments, and the risks
and benefits demonstrated in the clinical trials.
On
November 21, 1997, former President Clinton signed into law the FDA
Modernization Act. That act codified the FDA’s policy of granting “Fast
Track” approval for cancer therapies and other therapies intended to treat
serious or life threatening diseases and that demonstrate the potential to
address unmet medical needs. The Fast Track program emphasizes close,
early communications between the FDA and the sponsor to improve the efficiency
of preclinical and clinical development, and to reach agreement on the design of
the major clinical efficacy studies that will be needed to support
approval. Under the Fast Track program, a sponsor also has the option to
submit and receive review of parts of the NDA or BLA on a rolling schedule
approved by FDA, which expedites the review process.
The FDA’s
Guidelines for Industry Fast Track Development Programs require that a clinical
development program must continue to meet the criteria for Fast Track
designation for an application to be reviewed under the Fast Track
Program. Previously, the FDA approved cancer therapies primarily based on
patient survival rates or data on improved quality of life. While the FDA
could consider evidence of partial tumor shrinkage, which is often part of the
data relied on for approval, such information alone was usually insufficient to
warrant approval of a cancer therapy, except in limited situations. Under
the FDA’s new policy, which became effective on February 19, 1998, Fast Track
designation ordinarily allows a product to be considered for accelerated
approval through the use of surrogate endpoints to demonstrate
effectiveness. As a result of these provisions, the FDA has broadened
authority to consider evidence of partial tumor shrinkage or other surrogate
endpoints of clinical benefit for approval. This new policy is intended to
facilitate the study of cancer therapies and shorten the total time for
marketing approvals. Under accelerated approval, the manufacturer must
continue with the clinical testing of the product after marketing approval to
validate that the surrogate endpoint did predict meaningful clinical
benefit. To the extent applicable, we intend to take advantage of the Fast
Track Program to obtain accelerated approval on our future products, however, it
is too early to tell what effect, if any, these provisions may have on the
approval of our product candidates.
Other
Regulations
Various
Federal and state laws, regulations, and recommendations relating to safe
working conditions, laboratory practices, the experimental use of animals, and
the purchase, storage, movement, import, export, use, and disposal of hazardous
or potentially hazardous substances, including radioactive compounds and
infectious disease agents, are used in connection with our research or
applicable to our activities. They include, among others, the U.S. Atomic
Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and
Health Act, the National Environmental Policy Act, the Toxic Substances Control
Act, and Resources Conservation and Recovery Act, national restrictions on
technology transfer, import, export, and customs regulations, and other present
and possible future local, state, or federal regulation. The extent of
governmental regulation which might result from future legislation or
administrative action cannot be accurately predicted.
There is
a series of international harmonization treaties, known as the ICH treaties that
enable drug development to be conducted on an international basis. These
treaties specify the manner in which clinical trials are to be conducted, and if
trials adhere to the specified requirements, then they are accepted by the
regulatory bodies in the signatory countries. In this way, the
Advaxis Phase I study conducted outside of the U.S. is accepted by the
FDA.
Manufacturing
The FDA
requires that any drug or formulation to be tested in humans be manufactured in
accordance with its GMP regulations. This has been extended to include any
drug which will be tested for safety in animals in support of human
testing. The GMPs set certain minimum requirements for procedures,
record-keeping, and the physical characteristics of the laboratories used in the
production of these drugs.
We have
entered into an agreement with Cobra Biomanufacturing (now Recipharm) for the
purpose of manufacturing our vaccines. Recipharm has extensive experience
in manufacturing gene therapy products for investigational studies.
Recipharm is a full service manufacturing organization that manufactures and
supplies biologic based therapeutics for the pharmaceutical and biotech
industry. These services include the GMP manufacturing of stability
testing, and cell banking. Recipharm’s manufacturing plan for us calls for
several manufacturing stages, including process development, manufacturing of
non-GMP material for toxicology studies and manufacturing of GMP material for
the Phase I and Phase II trials.
15
We have
entered into a GMP compliant filing of ADXS11-001 agreement with Vibalogics
GmbH, Zeppelinstr. 2,27472 Cuxhaven, Germany to fill up to 5,000 vials of
our clinical supplies.
Beginning
in April 2008, we entered into a number of Agreements with Vibalogics to
manufacture clinical grade material for two new vaccines to develop in the
clinic as new drugs; ADXS31-142, a vaccine for the treatment of prostate cancer,
and ADXS31-164, a vaccine for the treatment of breast, brain and other cancers.
Cobra’s manufacturing plan for us calls for GMP manufacturing in several stages,
including process development, manufacturing of non-GMP material for toxicology
studies and manufacturing of GMP material for the Phase I and Phase II trials,
filling, finishing, and the development of a storage stable, room temperature,
dried form of our vaccines.
Competition
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. As a result,
our actual or proposed products could become obsolete before we recoup any
portion of our related research and development and commercialization
expenses. The biotechnology and biopharmaceutical industries are highly
competitive, and this competition comes from both biotechnology firms and from
major pharmaceutical and chemical companies, including Aduro Biotech, Antigenics
Inc., Avi BioPharma, Inc., Biomura Inc., Biovest International, Biosante
Pharmaceuticals Inc., Dendreon Corporation, Pharmexa-Epimmune Inc. , Genzyme
Corp., Progenics Pharmaceuticals Inc. and Vical Incorporated each of which is
pursuing cancer vaccines. Many of these companies have substantially
greater financial, marketing, and human resources than we do (including, in some
cases, substantially greater experience in clinical testing, manufacturing, and
marketing of pharmaceutical products). We also experience competition in
the development of our products from universities and other research
institutions and compete with others in acquiring technology from such
universities and institutions. In addition, certain of our products may be
subject to competition from products developed using other technologies, some of
which have completed numerous clinical trials.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector. Our competition will be determined in
part by the potential indications for which drugs are developed and ultimately
approved by regulatory authorities. Additionally, the timing of market
introduction of some of our potential products or of competitors’ products may
be an important competitive factor. Accordingly, the speed with which we
can develop products, complete preclinical testing, clinical trials and approval
processes and supply commercial quantities to market are expected to be
important competitive factors. We expect that competition among products
approved for sale will be based on various factors, including product efficacy,
safety, reliability, availability, price and patent position.
Merck has
developed the drug Gardasil and GlaxoSmithKline,
which we refer to as GSK, has developed the drug Cervarix which can
prevent cervical cancer by vaccinating women against the virus HPV, the cause of
the disease. Gardasil is directed against four HPV strains while Cervarix
is directed against two. Neither of these agents has an approved
indication for women who have a prior exposure to the HPV strains that they
protect against, nor are women protected from other strains of HPV that the
drugs do not treat. It has been written that these are cancer vaccines,
which is not true. They are anti-virus vaccines intended to protect
against strains of the HPV virus.
The
presence of these agents in the market does not eliminate the market for a
therapeutic vaccine directed against invasive cervical cancer and CIN for a
number of reasons:
HPV is
the most common sexually treated disease in the U.S., and since prior exposure
to the virus renders these anti-viral agents ineffective they tend to be limited
to younger women and do not offer protection for women who are already
infected. The number of women who are already infected with HPV is
estimated to be as much as (or more than) 25% of the female population of the
U.S.
There are
approximately 10 high risk strains of HPV, but these agents only protect against
the most common 2-4 strains. If a woman contracts a high risk HPV species
that is not one of those, the drugs will not work.
Women
with HPV are typically infected for over twenty years or more before they
manifest cervical cancer. Thus, the true prophylactic effect of these
drugs can only be inferred at this time. We believe that there currently
exists a significant population of young woman who have not received these
agents, or for whom they will not work, and who will manifest HPV related
cervical disease for the next 40+ years. We believe this population will
continue to grow until such time as a significant percentage of women who have
not been exposed to HPV are vaccinated; which we believe is not likely to occur
within the next decade or longer. We do not know at this time whether a
significant number of women will be vaccinated to have an effect on the
epidemiology of this disease.
With the
exception of the campaign to eradicate polio in which vaccination was mandatory
for all school age children, vaccination is a difficult model to accomplish
because it is virtually impossible to treat everyone in any given country, much
less the entire world. This is especially true for cervical cancer, as the
incentive for men to be vaccinated is small, and infected men keep the pathogen
circulating in the population.
Taken
together, experts believe that there will be a cervical cancer and CIN market
for the foreseeable future.
16
Scientific
Advisory Board
We
maintain a Scientific Advisory Board consisting of internationally recognized
scientists who advise us on scientific and technical aspects of our
business. The Scientific Advisory Board (SAB) meets on an as needed basis
to review specific projects and to assess the value of new technologies and
developments to us. In addition, individual members of the SAB meet with
us periodically to provide advice in particular areas of expertise. The
scientific advisory board consists of the following members, information with
respect to whom is set forth below: Yvonne Paterson, Ph.D.; Pramod Srivastava,
Ph.D.; Bennett Lorber, M.D.; David Weiner, Ph.D.; and Mark Einstein,
M.D.
Dr. Yvonne Paterson.
For a description of our relationship with Dr. Paterson, please see
“Partnerships and Agreements-Dr. Yvonne Paterson.”
Pramod Srivastava, Ph.D. Dr.
Srivastava is Professor of Immunology at the University of Connecticut School of
Medicine, where he is also Director of the Center for Immunotherapy of Cancer
and Infectious Diseases. He holds the Physicians Health Services Chair in
Cancer Immunology at the University of Connecticut School of Medicine.
Professor Srivastava is the Scientific Founder of Antigenics, Inc. He
serves on the Scientific Advisory Council of the Cancer Research Institute, New
York, and was a member of the Experimental Immunology Study Section of the
National Institutes of Health of the U.S. Government from 1994 to 1999. He
serves presently on the board of directors of two privately held companies:
Ikonisys, in New Haven, Connecticut and CambriaTech, Lugano, Switzerland.
In 1997, he was inducted into the Roll of Honor of the International Union
Against Cancer and was listed in Who’s Who in Science and Engineering. He
is among the twenty founding members of the Academy of Cancer Immunology, New
York. Dr. Srivastava obtained his bachelor’s degree in biology and
chemistry and a master’s degree in botany (paleontology) from the University of
Allahabad, India. He then studied yeast genetics at Osaka University,
Japan. He completed his Ph.D. in biochemistry at the Center for Cellular
and Molecular Biology, Hyderabad, India, where he began his work on tumor
immunity, including identification of the first proteins that can mediate tumor
rejection. He trained at Yale University and Sloan-Kettering Institute for
Cancer Research. Dr. Srivastava has held faculty positions at the Mount
Sinai School of Medicine and Fordham University in New York City.
Bennett Lorber, M.D.
Dr. Lorber attended Swarthmore College where he studied zoology and art
history. He graduated from the University of Pennsylvania School of
Medicine and did his residency in internal medicine and fellowship in infectious
diseases at Temple University, following which he joined the Temple
faculty. At Temple he rose through the ranks to become Professor of
Medicine and, in 1988, was named the first recipient of the Thomas Durant Chair
in Medicine. He is also a Professor of Microbiology and Immunology and
served as the Chief of the Section of Infectious Diseases until 2006. He
is a Fellow of the American College of Physicians, a Fellow of the Infectious
Diseases Society of America, and a Fellow of the College of Physicians of
Philadelphia where he serves as College Secretary and as a member of the Board
of Trustees. Dr. Lorber’s major interest in infectious diseases is in
human listeriosis, an area in which he is regarded as an international
authority. He has also been interested in the impact of societal changes
on infectious disease patterns as well the relationship between infectious
agents and chronic illness, and he has authored papers exploring these
associations. He has been repeatedly honored for his teaching. Among
his honors are 10 golden apples, the Temple University Great Teacher Award, the
Clinical Practice Award from the Pennsylvania College of Internal Medicine, and
the Bristol Award from the Infectious Diseases Society of America. In 1996
he was the recipient of an honorary Doctor of Science degree from Swarthmore
College.
David B. Weiner, Ph.D.
Dr. David Weiner received his B.S in Biology from the State University of
New York and performed undergraduate research in the Department of Microbiology,
Chaired by Dr. Arnie Levine, at Stony Brook University. He completed his
MS and Ph.D. in Developmental Biology/Immunology from the Children’s Hospital
Research Foundation at the University of Cincinnati in 1986. He completed
his Post Doctoral Fellowship in the Department of Pathology at Penn in 1989,
under the direction of Dr. Mark Greene. At that time he joined the Faculty
at the Wistar Institute in Philadelphia. He was recruited back to Penn in
1994. He is currently an Associate Professor with Tenure in the Department
of Pathology, and he is the Associate Chair of the Gene Therapy and Vaccines
Graduate Program at Penn. Of relevance during his career he has worked
extensively in the areas of molecular immunology, the development of vaccines
and vaccine technology for infectious diseases and in the area of molecular
oncology and immune therapy. His laboratory is considered one of the
founders of the field of DNA vaccines as his group not only was the first to
report on the use of this technology for vaccines against HIV, but was also the
first group to advance DNA vaccine technology to clinical evaluation. In
addition he has worked on the identification of novel approaches to inhibit HIV
infection by targeting the accessory gene functions of the virus. Dr.
Weiner has authored over 260 articles in peer reviewed journals and is the
author of over 28 awarded U.S. patents as well as their international
counterparts. He has served and still serves on many national and
international review boards and panels including the NIH Study section, WHO
advisory panels, the National Institute for Biological Standards and Control,
Department of Veterans Affairs Scientific Review Panel, as well as the FDA
Advisory panel - Center for Biologics Evaluation and Research, and Adult AIDS
Clinical Trial Group, among others. He also serves or has served in an
advisory capacity to several Biotechnology and Pharmaceutical Companies.
Dr. Weiner has, through training of young people in his laboratory, advanced
over 35 undergraduate scientists to Medical School or Doctoral Programs and has
trained 28 Post Doctoral Fellows and 7 Doctoral Candidates as well as served on
fourteen Doctoral Student Committees.
17
Mark Einstein, M.D. Dr.
Einstein received his BS degree in Biology from the University of Miami, where
he also received his MD with Research Distinction in Clinical Immunology.
He also has an MS in Clinical Research Methods, which he received with
Distinction. Dr. Einstein completed his residency in OB/GYN at Saint
Barnabas Medical Center, and was a Galloway Fellow in Gynecologic Oncology at
the Sloan-Kettering Cancer Center. Dr. Einstein has been at the Albert
Einstein Cancer Center and Montefiore Medical Center since 1999, where he has
been an attending physician, Assistant Professor of Gynecologic Oncology, and
currently the Director of Clinical Research of the Division of Gynecologic
Oncology at the Albert Einstein College of Medicine and Cancer Center, and at
the Montefiore Medical Center. He is a Fellow of the American College of
Obstetrics and Gynecology and the American College of Surgeons, as well as
belonging to various research groups such as the American Association for Cancer
Research and the American Society for Clinical Oncology. Dr. Einstein’s
honors and awards include; American Cancer Society Research Scholar, American
Professors in Gynecology and Obstetrics McNeil Faculty Award, ACOG/3M Research
Award, ACOG/Solvay Research Award, Berlex Oncology Foundation Scholar Award, and
others. Dr. Einstein is a member of the GOG Vaccine subcommittee, chairs
the Gynecologic Cancer Foundation National Cervical Cancer Education Campaign,
sits on the Translational Research Working Group Roundtable at NIH/NCI, the NIH
AIDS Malignancy Consortium, the Gynecologic Cancer Foundation Task Force for
Cervical Cancer Screening and Prevention, as well as three separate committees
for the Society of Gynecologic Oncologists. Dr. Einstein is very active in
the clinical assessment of new immunological technologies for the treatment of
gynecologic cancers.
Item
1A: Risk Factors.
You
should carefully consider the risks described below as well as other information
provided to you in this annual report, including information in the section of
this document entitled “Forward-Looking Statements.” The risks and uncertainties
described below are not the only ones facing us. Additional risks and
uncertainties not presently known to us or that we currently believe are
immaterial may also impair our business operations. If any of the following
risks actually occur, our business, financial condition or results of operations
could be materially adversely affected, the value of our common stock could
decline, and you may lose all or part of your investment.
Risks
Related to our Business
We are a development stage
company.
We are an
early stage development stage company with a history of losses and can provide
no assurance as to future operating results. As a result of losses which
will continue throughout our development stage, we may exhaust our financial
resources and be unable to complete the development of our production. Our
deficit will continue to grow during our drug development period.
We have
sustained losses from operations in each fiscal year since our inception, and we
expect losses to continue for the indefinite future, due to the substantial
investment in research and development. As of October 31, 2010, we had an
accumulated deficit $27,416,000 and shareholders’ deficiency of
$14,802,631. We expect to spend substantial additional sums on the
continued administration and research and development of proprietary products
and technologies with no certainty that our products will become commercially
viable or profitable as a result of these expenditures.
As
a result of our current lack of financial liquidity and negative stockholders
equity, our auditors have expressed substantial concern about our ability to
continue as a “going concern”.
Our
limited capital resources and operations to date have been funded primarily with
the proceeds from public and private equity and debt financings, NOL and
Research tax credits and income earned on investments and grants. Based on our
currently available cash, we do not have adequate cash on hand to cover our
anticipated expenses for the next 12 months. If we fail to raise a significant
amount of capital, we may need to significantly curtail operations, cease
operations or seek federal bankruptcy protection in the near future. These
conditions have caused our auditors to raise substantial doubt about our ability
to continue as a going concern. Consequently, the audit report prepared by
our independent public accounting firm relating to our financial statements for
the year ended October 31, 2010 included a going concern explanatory
paragraph.
There
can be no assurance that we will receive funding from Optimus in connection with
the Series B preferred equity financing.
We have
entered into the Series B purchase agreement, pursuant to which Optimus has
agreed to purchase up to $7.5 million of our Series B preferred stock from time
to time, subject to our ability to effect and maintain an effective registration
statement for the shares underlying the warrant issued to an affiliate of
Optimus to purchase up to 40,500,000 shares of common stock, issued in
connection with the transaction. As of January 27, 2011, Optimus had
purchased an aggregate of 422 shares of Series B preferred stock and remains
obligated, from time to time until July 19, 2013, to purchase up to an
additional 328 shares of Series B preferred stock upon notice from us to
Optimus, if certain conditions set forth in the Series B purchase agreement are
satisfied, including among things that: (i) we must be in compliance with our
SEC reporting obligations, (ii) our common stock must be quoted on the OTC
Bulletin Board or another eligible trading market, (iii) a material adverse
effect relating to, among other things, our results of operations, assets,
business or financial condition must not have occurred since July 19, 2010,
other than losses incurred in the ordinary course of business, (iv) we must not
be in default under any material agreement, (v) Optimus and its affiliates must
not own more than 9.99% of our outstanding common stock, and (vi) we must comply
with certain other requirements set forth in the Series B purchase
agreement. If we fail to comply with any of these requirements, Optimus
will not be obligated to purchase our Series B preferred stock and we will not
receive any funding from Optimus. Moreover, if we exercise our option to require
Optimus to purchase our Series B preferred stock, and our common stock has a
closing price of less than $0.15 per share on the trading day immediately
preceding our delivery of the exercise notice, we may trigger at closing
certain anti-dilution protection provisions in certain outstanding warrants that
would result in an adjustment to the number and price of certain outstanding
warrants.
18
We
may not be able to require Optimus to purchase the entire $7.5 million of Series
B preferred stock issuable under the Series B purchase agreement.
In
connection with our Series B preferred equity financing, we issued to an
affiliate of Optimus a three-year warrant to purchase up to 40,500,000 shares of
our common stock, at an initial exercise price of $0.25 per share. As
of January 27, 2011, 4,010,038 warrants remain outstanding. The
warrant provides that on each tranche notice date under the Series B purchase
agreement, (i) that portion of the warrant equal to 135% of the tranche amount
will vest and become exercisable (and such vested portion may be exercised at
any time during the exercise period on or after such tranche notice date) and
(ii) the exercise price will be adjusted to the closing sale price of a share of
our common stock on such tranche notice date. We are not permitted to
deliver a tranche notice under the Series B purchase agreement if the number of
registered shares underlying the warrant is insufficient to cover the portion of
the warrant that will vest and become exercisable in connection with such
tranche notice. We currently have 4,010,038 registered shares
underlying the warrant available under our prospectus and will likely need to
register additional warrants shares in order to require Optimus to purchase the
remaining shares of Series B preferred stock. We cannot assure you
that we will be able to timely effect and maintain a registration statement for
any such additional warrant shares so as to permit us to require Optimus to
purchase the entire $7.5 million of Series B preferred stock under the Series B
purchase agreement.
Our
business will require substantial additional investment that we have not yet
secured, and our failure to raise capital and/or pursue partnering opportunities
will materially adversely affect our business, financial condition and results
of operations.
We expect
to continue to spend substantial amounts on research and development, including
conducting clinical trials for our product candidates. However, we will not have
sufficient resources to develop fully any new products or technologies unless we
are able to raise substantial additional financing on acceptable terms, secure
funds from new partners or consummate a preferred equity financing under the
Series B purchase agreement. We cannot be assured that financing will be
available at all. Our failure to raise a significant amount of capital in
the near future, will materially adversely affect our business, financial
condition and results of operations, and we may need to significantly curtail
operations, cease operations or seek federal bankruptcy protection in the near
future. Any additional investments or resources required would be
approached, to the extent appropriate in the circumstances, in an incremental
fashion to attempt to cause minimal disruption or dilution. Any additional
capital raised through the sale of equity or convertible debt securities will
result in dilution to our existing stockholders. No assurances can be
given, however, that we will be able to achieve these goals or that we will be
able to continue as a going concern.
We
have significant indebtedness which may restrict our business and operations,
adversely affect our cash flow and restrict our future access to sufficient
funding to finance desired growth.
As of
December 31, 2010, our total outstanding indebtedness was approximately $2.14
million, which included the face value of our outstanding bridge notes in the
amount of approximately $1.5 million, a note outstanding to BioAdvance in the
amount of $40,000 and the note outstanding to our chief executive officer in the
amount of approximately $0.6 million. The total face value of the notes
outstanding as of November 30, 2010 is due on or before August 31, 2011.
We dedicate a substantial portion of our cash to pay interest and principal on
our debt. If we are not able to service our debt, we would need to refinance all
or part of that debt, sell assets, borrow more money or sell securities, which
we may not be able to do on commercially reasonable terms, or at all. In
addition, our failure to timely repay (or extend) amounts due and owing under
our outstanding senior and junior bridge notes, may trigger the anti-dilution
protection provisions in substantially all of our warrants (other than the
warrants issued to the affiliate of Optimus), in which case holders of our
common stock will experience significant additional dilution. As of
December 31, 2010, approximately 73 million warrants would be subject to these
anti-dilution protection provisions.
The terms
of our notes include customary events of default and covenants that restrict our
ability to incur additional indebtedness. These restrictions and covenants may
prevent us from engaging in transactions that might otherwise be considered
beneficial to us. A breach of the provisions of our indebtedness could result in
an event of default under our outstanding notes. If an event of default
occurs under our notes (after any applicable notice and cure periods), the
holders would be entitled to accelerate the repayment of amounts outstanding,
plus accrued and unpaid interest. In the event of a default under
our senior indebtedness, the holders could also foreclose against the assets
securing such obligations. In the event of a foreclosure on all or
substantially all of our assets, we may not be able to continue to operate as a
going concern.
Our
Limited operating history does not afford investors a sufficient history on
which to base an investment decision.
We
commenced our Listeria
System vaccine development business in February 2002 and have existed as a
development stage company since such time. Prior thereto we conducted no
business. Accordingly, we have a limited operating history.
Investors must consider the risks and difficulties we have encountered in the
rapidly evolving vaccine and therapeutic biopharmaceutical industry. Such
risks include the following:
·
|
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 complex financing agreements with 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.
|
19
We cannot
be certain that our strategy will be successful or that we will successfully
address these risks. In the event that we do not successfully address
these risks, our business, prospects, financial condition and results of
operations could be materially and adversely affected. We may be required
to reduce our staff, discontinue certain research or development programs of our
future products and cease to operate.
We
can provide no assurance of the successful and timely development of new
products.
Our
products are at various stages of research and development. Further
development and extensive testing will be required to determine their technical
feasibility and commercial viability. Our success will depend on our
ability to achieve scientific and technological advances and to translate such
advances into reliable, commercially competitive products on a timely
basis. Immunotherapy and vaccine products that we may develop are not
likely to be commercially available until five to ten or more years. The
proposed development schedules for our products may be affected by a variety of
factors, including technological difficulties, proprietary technology of others,
and changes in governmental regulation, many of which will not be within our
control. Any delay in the development, introduction or marketing of our
products could result either in such products being marketed at a time when
their cost and performance characteristics would not be competitive in the
marketplace or in the shortening of their commercial lives. In light of
the long-term nature of our projects, the unproven technology involved and the
other factors described elsewhere in “Risk Factors,” there can be no assurance
that we will be able to successfully complete the development or marketing of
any new products.
Our
research and development expenses are subject to uncertainty.
Factors
affecting our research and development expenses include, but are not limited
to:
·
|
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.
|
We
are subject to numerous risks inherent in conducting clinical
trials.
We
outsource the management of our clinical trials to third parties.
Agreements with clinical investigators and medical institutions for clinical
testing and with other third parties for data management services, place
substantial responsibilities on these parties which, if unmet, could result in
delays in, or termination of, our clinical trials. For example, if any of
our clinical trial sites fail to comply with FDA-approved good clinical
practices, we may be unable to use the data gathered at those sites. If
these clinical investigators, medical institutions or other third parties do not
carry out their contractual duties or obligations or fail to meet expected
deadlines, or if the quality or accuracy of the clinical data they obtain is
compromised due to their failure to adhere to our clinical protocols or for
other reasons, our clinical trials may be extended, delayed or terminated, and
we may be unable to obtain regulatory approval for or successfully commercialize
our agent ADXS11-001. We are not certain that we will successfully recruit
enough patients to complete our clinical trials. Delays in recruitment and
such agreements would delay the initiation of the Phase II trials of
ADXS11-001.
We or our
regulators may suspend or terminate our clinical trials for a number of
reasons. We may voluntarily suspend or terminate our clinical trials if at
any time we believe they present an unacceptable risk to the patients enrolled
in our clinical trials. In addition, regulatory agencies may order the
temporary or permanent discontinuation of our clinical trials at any time if
they believe that the clinical trials are not being conducted in accordance with
applicable regulatory requirements or that they present an unacceptable safety
risk to the patients enrolled in our clinical trials.
Our
clinical trial operations are subject to regulatory inspections at any
time. If regulatory inspectors conclude that we or our clinical trial
sites are not in compliance with applicable regulatory requirements for
conducting clinical trials, we may receive reports of observations or warning
letters detailing deficiencies, and we will be required to implement corrective
actions. If regulatory agencies deem our responses to be inadequate, or
are dissatisfied with the corrective actions we or our clinical trial sites have
implemented, our clinical trials may be temporarily or permanently discontinued,
we may be fined, we or our investigators may be precluded from conducting any
ongoing or any future clinical trials, the government may refuse to approve our
marketing applications or allow us to manufacture or market our products, and we
may be criminally prosecuted.
The
successful development of biopharmaceuticals is highly uncertain.
Successful
development of biopharmaceuticals is highly uncertain and is dependent on
numerous factors, many of which are beyond our control. Products that
appear promising in the early phases of development may fail to reach the market
for several reasons including:
20
·
|
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;
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|
|
·
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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 Biologics License
Application preparation, discussions with the FDA, an FDA request for
additional preclinical or clinical data, or unexpected safety or
manufacturing issues;
|
|
·
|
Manufacturing
costs, formulation issues, 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.
|
Success
in preclinical and early clinical studies does not ensure that large-scale
clinical studies will be successful. Clinical results are frequently
susceptible to varying interpretations that may delay, limit or prevent
regulatory approvals. The length of time necessary to complete clinical studies
and to submit an application for marketing approval for a final decision by a
regulatory authority varies significantly from one product to the next, and may
be difficult to predict.
We
must comply with significant government regulations.
The
research and development, manufacture and marketing of human therapeutic and
diagnostic products are subject to regulation, primarily by the FDA in the U.S.
and by comparable authorities in other countries. These national agencies
and other federal, state, local and foreign entities regulate, among other
things, research and development activities (including testing in animals and in
humans) and the testing, manufacturing, handling, labeling, storage, record
keeping, approval, advertising and promotion of the products that we are
developing. Noncompliance with applicable requirements can result in
various adverse consequences, including delay in approving or refusal to approve
product licenses or other applications, suspension or termination of clinical
investigations, revocation of approvals previously granted, fines, criminal
prosecution, recall or seizure of products, injunctions against shipping
products and total or partial suspension of production and/or refusal to allow a
company to enter into governmental supply contracts.
The
process of obtaining requisite FDA approval has historically been costly and
time-consuming. Current FDA requirements for a new human biological
product to be marketed in the U.S. include: (1) the successful conclusion of
preclinical laboratory and animal tests, if appropriate, to gain preliminary
information on the product’s safety; (2) filing with the FDA of an
Investigational New Drug Application, which we refer to as an IND, to conduct
human clinical trials for drugs or biologics; (3) the successful completion of
adequate and well-controlled human clinical investigations to establish the
safety and efficacy of the product for its recommended use; and (4) filing by a
company and acceptance and approval by the FDA of a Biologic License
Application, which we refer to as a BLA, for a biological product, to allow
commercial distribution of a biologic product. A delay in one or more of
the procedural steps outlined above could be harmful to us in terms of getting
our product candidates through clinical testing and to market.
We
can provide no assurance that our products will obtain regulatory approval or
that the results of clinical studies will be favorable.
In
February 2006, we received permission from the appropriate governmental agencies
in Israel, Mexico and Serbia to conduct Phase I clinical testing in those
countries of ADXS11-001, our Listeria -based cancer
vaccine that targets cervical cancer in women. The study was completed in
the fiscal quarter ended January 31, 2008. The next step was to
manufacture and test our product for future sale or distribution in the U.S.
which required a filing of an IND with the FDA for our Phase II CIN trial. The
filing was based on information from the Phase I trial and other pre-clinical
information. On January 6, 2009 we received permission to conduct our clinical
trial under this IND from the FDA. However, even though we are allowed to
conduct this trial, as with any experimental agent, we are always at risk to be
placed on clinical hold by the FDA at any time as our product may have effects
on humans are not fully understood or documented. There can be delays in
obtaining FDA or any other necessary regulatory approvals of any proposed
product and failure to receive such approvals would have an adverse effect on
the product’s potential commercial success and on our business, prospects,
financial condition and results of operations. In addition, it is possible
that a product may be found to be ineffective or unsafe due to conditions or
facts which arise after development has been completed and regulatory approvals
have been obtained. In this event, we may be required to withdraw such
product from the market. To the extent that our success will depend on any
regulatory approvals from governmental authorities outside of the U.S. that
perform roles similar to that of the FDA, uncertainties similar to those stated
above will also exist.
We
rely upon patents to protect our technology. We may be unable to protect
our intellectual property rights and we may be liable for infringing the
intellectual property rights of others.
Our
ability to compete effectively will depend on our ability to maintain the
proprietary nature of our technologies, including the Listeria System, and the
proprietary technology of others with whom we have entered into licensing
agreements.
21
As of
December 31, 2010 we have 32 patents that have been issued and licenses for 33
patent applications that are pending (including the 23 patent applications
obtained in May 2010). We have licensed most of these patents and
applications from Penn and we have obtained the rights to all future patent
applications originating in the laboratories of Dr. Yvonne Paterson and Dr. Fred
Frankel. Further, we rely on a combination of trade secrets and
nondisclosure, and other contractual agreements and technical measures to
protect our rights in the technology. We depend upon confidentiality
agreements with our officers, employees, consultants, and subcontractors to
maintain the proprietary nature of the technology. These measures may not afford
us sufficient or complete protection, and others may independently develop
technology similar to ours, otherwise avoid the confidentiality agreements, or
produce patents that would materially and adversely affect our business,
prospects, financial condition, and results of operations. Such
competitive events, technologies and patents may limit our ability to raise
funds, prevent other companies from collaborating with us, and in certain cases
prevent us from further developing our technology due to third party patent
blocking rights.
We are
aware of a private company, Anza Therapeutics, Inc (formerly Cerus Corporation),
which is no longer in existence, but had been developing Listeria vaccines. We
are also aware of Aduro Biotech, a company comprised in part of former Cerus and
Anza employees that has recently formed to investigate Listeria vaccines. We
believe that through our exclusive license with Penn we have earliest known and
dominant patent position in the U.S. for the use of recombinant Listeria monocytogenes
expressing proteins or tumor antigens as a vaccine for the treatment of
infectious diseases and tumors. We successfully defended our intellectual
property by contesting a challenge made by Anza to our patent position in Europe
on a claim not available in the U.S. The European Patent Office, which we
refer to as the EPO, Board of Appeals in Munich, Germany has ruled in favor of
The Trustees of Penn and its exclusive licensee Advaxis and reversed a patent
ruling that revoked a technology patent that had resulted from an opposition
filed by Anza. The ruling of the EPO Board of Appeals is final and cannot
be appealed. The granted claims, the subject matter of which was
discovered by Dr. Yvonne Paterson, scientific founder of Advaxis, are directed
to the method of preparation and composition of matter of recombinant bacteria
expressing tumor antigens for treatment of patients with cancer. Based on
searches of publicly available databases, we do not believe that Anza, Aduro or
any other third party owns any published Listeria patents or has any
issued patent claims that might materially and adversely affect our ability to
operate our business as currently contemplated in the field of recombinant Listeria monocytogenes.
Additionally, our proprietary position that is the issued patents and licenses
for pending applications restricts anyone from using plasmid based Listeria constructs, or those
that are bioengineered to deliver antigens fused to LLO, ActA, or fragments of
LLO or ActA.
We
are dependent upon our license agreement with Penn; if we fail to make payments
due and owing to Penn under our license agreement, our business will be
materially and adversely affected.
Pursuant
to the terms of our Second Amendment Agreement with
Penn, as amended, we have acquired exclusive licenses for an additional 23
patent applications related to our proprietary Listeria vaccine
technology. However, as of January 27, 2011, we still owed Penn
approximately $212,000 in patent expenses and $0 in sponsored research agreement
fees.
If we are
unable to maintain and/or obtain licenses, we may have to develop alternatives
to avoid infringing on the patents of others, potentially causing increased
costs and delays in product development and introduction or precluding the
development, manufacture, or sale of planned products. Some of our licenses
provide for limited periods of exclusivity that require minimum license fees and
payments and/or may be extended only with the consent of the licensor. We can
provide no assurance that we will be able to meet these minimum license fees in
the future or that these third parties will grant extensions on any or all such
licenses. This same restriction may be contained in licenses obtained in the
future. Additionally, we can provide no assurance that the patents underlying
any licenses will be valid and enforceable. Furthermore, in 2001, an issue arose
regarding the inventorship of U.S. Patent 6,565,852 and U.S. Patent Application
No. 09/537,642. These patent rights are included in the patent rights licensed
by us from Penn. GSK, Penn and we expect that the issue will be resolved through
a correction of inventorship to add certain GSK inventors, where necessary and
appropriate, an assignment of GSK’s possible rights under these patent rights to
Penn, and a sublicense from us to GSK of certain subject matter, which is not
central to our business plan. To date, this arrangement has not been finalized
and we cannot assure that this issue will ultimately be resolved in the manner
described above. To the extent any products developed by us are based on
licensed technology, royalty payments on the licenses will reduce our gross
profit from such product sales and may render the sales of such products
uneconomical.
We
have no manufacturing, sales, marketing or distribution capability and we must
rely upon third parties for such.
We do not
intend to create facilities to manufacture our products and therefore are
dependent upon third parties to do so. We currently have an agreement with
Cobra Manufacturing for production of our immunotherapies and vaccines for
research and development and testing purposes. Our reliance on third
parties for the manufacture of our products creates a dependency that could
severely disrupt our research and development, our clinical testing, and
ultimately our sales and marketing efforts if the source of such supply proves
to be unreliable or unavailable. If the contracted manufacturing source is
unreliable or unavailable, we may not be able to replace the development of our
product candidates, our clinical testing program may not be able to go forward
and our entire business plan could fail.
If
we are unable to establish or manage strategic collaborations in the future, our
revenue and product development may be limited.
Our
strategy includes eventual substantial reliance upon strategic collaborations
for marketing and commercialization of ADXS11-001, and we may rely even more on
strategic collaborations for research, development, marketing and
commercialization of our other product candidates. To date, we have not
entered into any strategic collaborations with third parties capable of
providing these services although we have been heavily reliant upon third party
outsourcing for our clinical trials execution. In addition, we have not
yet marketed or sold any of our product candidates or entered into successful
collaborations for these services in order to ultimately commercialize our
product candidates. Establishing strategic collaborations is difficult and
time-consuming. Our discussion with potential collaborators may not lead
to the establishment of collaborations on favorable terms, if at all. For
example, potential collaborators may reject collaborations based upon their
assessment of our financial, regulatory or intellectual property position.
If we successfully establish new collaborations, these relationships may never
result in the successful development or commercialization of our product
candidates or the generation of sales revenue. To the extent that we enter
into co-promotion or other collaborative arrangements, our product revenues are
likely to be lower than if we directly marketed and sold any products that we
may develop.
22
Management
of our relationships with our collaborators will require:
·
|
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
|
|
·
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effective
allocation of our resources to multiple
projects.
|
If we
continue to enter into research and development collaborations at the early
phases of product development, our success will in part depend on the
performance of our corporate collaborators. We will not directly control
the amount or timing of resources devoted by our corporate collaborators to
activities related to our product candidates. Our corporate collaborators
may not commit sufficient resources to our research and development programs or
the commercialization, marketing or distribution of our product
candidates. If any corporate collaborator fails to commit sufficient
resources, our preclinical or clinical development programs related to this
collaboration could be delayed or terminated. Also, our collaborators may
pursue existing or other development-stage products or alternative technologies
in preference to those being developed in collaboration with us. Finally,
if we fail to make required milestone or royalty payments to our collaborators
or to observe other obligations in our agreements with them, our collaborators
may have the right to terminate those agreements.
We
may incur substantial liabilities from any product liability claims if our
insurance coverage for those claims is inadequate.
We face
an inherent risk of product liability exposure related to the testing of our
product candidates in human clinical trials, and will face an even greater risk
if the product candidates are sold commercially. An individual may bring a
liability claim against us if one of the product candidates causes, or merely
appears to have caused, an injury. If we cannot successfully defend
ourselves against the product liability claim, we will incur substantial
liabilities. Regardless of merit or eventual outcome, liability claims may
result in:
·
|
decreased
demand for our product candidates;
|
|
|
·
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damage
to our reputation;
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·
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withdrawal
of clinical trial participants;
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·
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costs
of related litigation;
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·
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substantial
monetary awards to patients or other claimants;
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·
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loss
of revenues;
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·
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the
inability of commercialize product candidates;
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·
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increased
difficulty in raising required additional funds in the private and public
capital markets;
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·
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substantial
monetary awards to patients or other claimants;
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·
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loss
of revenues;
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·
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the
inability to commercialize product candidates; and
|
|
·
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increased
difficulty in raising required additional funds in the private and public
capital markets.
|
We have
insurance coverage on our Phase II CIN and cervical cancer trials for each
clinical trial site. We do not have product liability insurance because we
do not have products on the market. We currently are in the process of
obtaining insurance coverage and to expand such coverage to include the sale of
commercial products if marketing approval is obtained for any of our product
candidates. However, insurance coverage is increasingly expensive and we
may not be able to maintain insurance coverage at a reasonable cost and we may
not be able to obtain insurance coverage that will be adequate to satisfy any
liability that may arise.
We
may incur significant costs complying with environmental laws and
regulations.
We and
our contracted third parties will use hazardous materials, including chemicals
and biological agents and compounds that could be dangerous to human health and
safety or the environment. As appropriate, we will store these materials
and wastes resulting from their use at our or our outsourced laboratory facility
pending their ultimate use or disposal. We will contract with a third
party to properly dispose of these materials and wastes. We will be
subject to a variety of federal, state and local laws and regulations governing
the use, generation, manufacture, storage, handling and disposal of these
materials and wastes. We may also incur significant costs complying with
environmental laws and regulations adopted in the future.
23
If
we use biological and hazardous materials in a manner that causes injury, we may
be liable for damages.
Our
research and development and manufacturing activities will involve the use of
biological and hazardous materials. Although we believe our safety
procedures for handling and disposing of these materials will comply with
federal, state and local laws and regulations, we cannot entirely eliminate the
risk of accidental injury or contamination from the use, storage, handling or
disposal of these materials. We do not carry specific biological or
hazardous waste insurance coverage, workers compensation or property and
casualty and general liability insurance policies which include coverage for
damages and fines arising from biological or hazardous waste exposure or
contamination. Accordingly, in the event of contamination or injury, we
could be held liable for damages or penalized with fines in an amount exceeding
our resources, and our clinical trials or regulatory approvals could be
suspended or terminated.
We
need to attract and retain highly skilled personnel; we may be unable to
effectively manage growth with our limited resources.
As of
October 31, 2010, we had eleven employees. We do not intend to
significantly expand our operations and staff unless we get adequate
financing. If we receive such funding then our new employees may
include key managerial, technical, financial, research and development and
operations personnel who will not have been fully integrated into our
operations. We will be required to expand our operational and financial
systems significantly and to expand, train and manage our work force in order to
manage the expansion of our operations. Our failure to fully integrate any
new employees into our operations could have a material adverse effect on our
business, prospects, financial condition and results of operations.
We
operate under an agreement with AlphaStaff, a professional employment
organization that provides us with payroll and human resources services.
Our ability to attract and retain highly skilled personnel is critical to our
operations and expansion. We face competition for these types of personnel
from other technology companies and more established organizations, many of
which have significantly larger operations and greater financial, technical,
human and other resources than we have. We may not be successful in
attracting and retaining qualified personnel on a timely basis, on competitive
terms, or at all. If we are not successful in attracting and retaining
these personnel, our business, prospects, financial condition and results of
operations will be materially adversely affected. In such circumstances we
may be unable to conduct certain research and development programs, unable to
adequately manage our clinical trials and other products, and unable to
adequately address our management needs. In addition, from time to time,
we are unable to make payroll due to our lack of cash.
We
depend upon our senior management and key consultants and their loss or
unavailability could put us at a competitive disadvantage.
We depend
upon the efforts and abilities of our senior executives, as well as the services
of several key consultants, including Yvonne Paterson, Ph.D. The loss or
unavailability of the services of any of these individuals for any significant
period of time could have a material adverse effect on our business, prospects,
financial condition and results of operations. We have not obtained, do
not own, nor are we the beneficiary of, key-person life insurance.
Risks
Related to the Biotechnology / Biopharmaceutical Industry
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. We may be
unable to compete with more substantial enterprises.
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. Competition
in the biopharmaceutical industry is based significantly on scientific and
technological factors. These factors include the availability of patent
and other protection for technology and products, the ability to commercialize
technological developments and the ability to obtain governmental approval for
testing, manufacturing and marketing. We compete with specialized
biopharmaceutical firms in the U.S., Europe and elsewhere, as well as a growing
number of large pharmaceutical companies that are applying biotechnology to
their operations. Many biopharmaceutical companies have focused their
development efforts in the human therapeutics area, including cancer. Many
major pharmaceutical companies have developed or acquired internal biotechnology
capabilities or made commercial arrangements with other biopharmaceutical
companies. These companies, as well as academic institutions and
governmental agencies and private research organizations, also compete with us
in recruiting and retaining highly qualified scientific personnel and
consultants. Our ability to compete successfully with other companies in
the pharmaceutical field will also depend to a considerable degree on the
continuing availability of capital to us.
We are
aware of certain products under development or manufactured by competitors that
are used for the prevention, diagnosis, or treatment of certain diseases we have
targeted for product development. Various companies are developing
biopharmaceutical products that potentially directly compete with our product
candidates even though their approach to such treatment is different. The
biotechnology and biopharmaceutical industries are highly competitive, and this
competition comes from both biotechnology firms and from major pharmaceutical
and chemical companies, including Aduro Biotech, Antigenics Inc., Avi BioPharma,
Inc., Biomura Inc., Biovest International, Biosante Pharmaceuticals Inc.,
Dendreon Corporation, Pharmexa-Epimmune Inc. , Genzyme Corp., Progenics
Pharmaceuticals Inc. and Vical Incorporated each of which is pursuing cancer
vaccines.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector with a superior technology that is both safer
and more effective than our competitors. Our competition will be
determined in part by the potential indications for which drugs are developed
and ultimately approved by regulatory authorities. Additionally, the
timing of market introduction of some of our potential products or of
competitors’ products may be an important competitive factor. Accordingly,
the relative speed with which we can develop products, complete preclinical
testing, clinical trials and approval processes and supply commercial quantities
to market is expected to be important competitive factors. We expect that
competition among products approved for sale will be based on various factors,
including product efficacy, safety, reliability, availability, price and patent
position.
24
Risks
Related to the Securities Markets and Investments in our Common
Stock
The
price of our common stock may be volatile.
The
trading price of our common stock may fluctuate substantially. The price
of our common stock that will prevail in the market after the sale of the shares
of common stock by certain selling stockholders may be higher or lower than
the price you have paid, depending on many factors, some of which are beyond our
control and may not be related to our operating performance. These
fluctuations could cause you to lose part or all of your investment in our
common stock. Those factors that could cause fluctuations include, but are
not limited to, the following:
·
|
price
and volume fluctuations in the overall stock market from time to
time;
|
|
·
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fluctuations
in stock market prices and trading volumes of similar
companies;
|
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·
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actual
or anticipated changes in our net loss or fluctuations in our operating
results or in the expectations of securities analysts;
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·
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the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Series B purchase
agreement;
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·
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general
economic conditions and trends;
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·
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major
catastrophic events;
|
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·
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sales
of large blocks of our stock;
|
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|
·
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significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
|
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·
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departures
of key personnel;
|
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·
|
changes
in the regulatory status of our product candidates, including results of
our clinical trials;
|
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·
|
events
affecting Penn or any future collaborators;
|
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·
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announcements
of new products or technologies, commercial relationships or other events
by us or our competitors;
|
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·
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regulatory
developments in the U.S. and other countries;
|
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·
|
failure
of our common stock to be listed or quoted on the Nasdaq Stock Market,
NYSE Amex Equities or other national market system;
|
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·
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changes
in accounting principles; and
|
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·
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discussion
of us or our stock price by the financial and scientific press and in
online investor communities.
|
In the
past, following periods of volatility in the market price of a company’s
securities, securities class action litigation has often been brought against
that company. Due to the potential volatility of our stock price, we may
therefore be the target of securities litigation in the future. Securities
litigation could result in substantial costs and divert management’s attention
and resources from our business.
You
may have difficulty selling our shares because they are deemed “penny
stocks.”
Our
common stock is deemed to be “penny stock” as that term is defined in Rule
3a51-1, promulgated under the Exchange Act. Penny stocks are, generally,
stocks:
·
|
with
a price of less than $5.00 per share;
|
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|
·
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that
are neither traded on a “recognized” national exchange nor listed on an
automated quotation system sponsored by a registered national securities
association meeting certain minimum initial listing standards;
and
|
|
·
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of
issuers with net tangible assets less than $2.0 million (if the issuer has
been in continuous operation for at least three years) or $5.0 million (if
in continuous operation for less than three years), or with average
revenue of less than $6.0 million for the last three
years.
|
Section
15(g) of the Exchange Act and Rule 15g-2 promulgated thereunder require
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document before effecting any transaction in a
“penny stock” for the investor’s account. We urge potential investors to
obtain and read this disclosure carefully before purchasing any shares that are
deemed to be “penny stock.”
Rule
15g-9 promulgated under the Exchange Act requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any “penny stock” to that investor. This procedure requires the
broker-dealer to:
·
|
obtain
from the investor information about his or her financial situation,
investment experience and investment objectives;
|
|
|
·
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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;
|
25
|
·
|
provide
the investor with a written statement setting forth the basis on which the
broker-dealer made his or her determination; and
|
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·
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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.
|
Compliance
with these requirements may make it harder for investors in our common stock to
resell their shares to third parties. Accordingly, our common stock should
only be purchased by investors, who understand that such investment is a
long-term and illiquid investment, and are capable of and prepared to bear the
risk of holding our common stock for an indefinite period of time.
A
limited public trading market may cause volatility in the price of our common
stock.
Our
common stock began trading on the OTC Bulletin Board on July 28, 2005 and is
quoted under the symbol ADXS.OB. The quotation of our common stock on the
OTC Bulletin Board does not assure that a meaningful, consistent and liquid
trading market currently exists, and in recent years such market has experienced
extreme price and volume fluctuations that have particularly affected the market
prices of many smaller companies like us. Our common stock is thus subject
to this volatility. Sales of substantial amounts of common stock, or the
perception that such sales might occur, could adversely affect prevailing market
prices of our common stock and our stock price may decline substantially in a
short time and our stockholders could suffer losses or be unable to liquidate
their holdings. Also there are large blocks of restricted stock that have
met the holding requirements under Rule 144 that can be unrestricted and
sold. Our stock is thinly traded due to the limited number of shares
available for trading on the market thus causing large swings in
price.
There
is no assurance of an established public trading market.
A regular
trading market for our common stock may not be sustained in the future.
The effect on the OTC Bulletin Board of these rule changes and other proposed
changes cannot be determined at this time. The OTC Bulletin Board is an
inter-dealer, over-the-counter market that provides significantly less liquidity
than the Nasdaq Stock Market. Quotes for stocks included on the OTC
Bulletin Board are not listed in the financial sections of newspapers. As such,
investors and potential investors may find it difficult to obtain accurate stock
price quotations, and holders of our common stock may be unable to resell their
securities at or near their original offering price or at any price.
Market prices for our common stock will be influenced by a number of factors,
including:
·
|
the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Series B purchase
agreement;
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·
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changes
in interest rates;
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·
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significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
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·
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competitive
developments, including announcements by competitors of new products or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital commitments;
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·
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variations
in quarterly operating results;
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·
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change
in financial estimates by securities analysts;
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the
depth and liquidity of the market for our common stock;
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·
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investor
perceptions of our company and the technologies industries generally;
and
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·
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general
economic and other national
conditions.
|
We
may not be able to achieve secondary trading of our stock in certain states
because our common stock is not nationally
traded.
Because
our common stock is not listed for trading on a national securities exchange,
our common stock is subject to the securities laws of the various states and
jurisdictions of the U.S. in addition to federal securities law. This
regulation covers any primary offering we might attempt and all secondary
trading by our stockholders. If we fail to take appropriate steps to
register our common stock or qualify for exemptions for our common stock in
certain states or jurisdictions of the U.S., the investors in those
jurisdictions where we have not taken such steps may not be allowed to purchase
our stock or those who presently hold our stock may not be able to resell their
shares without substantial effort and expense. These restrictions and
potential costs could be significant burdens on our stockholders.
If
we fail to remain current on our reporting requirements, we could be removed
from the OTC Bulletin Board, which would limit the ability of broker-dealers to
sell our securities and the ability of stockholders to sell their securities in
the secondary market.
Companies trading on the OTC Bulletin
Board, such as us, must be reporting issuers under Section 12 of the Exchange
Act, as amended, and must be current in their reports under Section 13, in order
to maintain price quotation privileges on the OTC Bulletin Board. For our
third quarter 2009 we were unable to file our quarterly report on Form 10-Q in a
timely manner, but we were able to make the filing and cure our compliance
deficiency with the OTC Bulletin Board within the grace period allowed by the
OTC Bulletin Board. In addition, for the year ending October 31, 2009 we
were unable to file our annual report on Form 10-K in a timely manner, but we
were able to make the filing and cure our compliance deficiency with the OTC
Bulletin Board within the grace period allowed by the OTC Bulletin Board.
If we fail to remain current on our reporting requirements, we could be removed
from the OTC Bulletin Board. As a result, the market liquidity for our
securities could be severely adversely affected by limiting the ability of
broker-dealers to sell our securities and the ability of stockholders to sell
their securities in the secondary market.
26
Our
internal control over financial reporting and our disclosure controls and
procedures have been ineffective in the past, and may be ineffective again in
the future, and failure to improve them at such time could lead to errors in our
financial statements that could require a restatement or untimely filings, which
could cause investors to lose confidence in our reported financial information,
and a decline in our stock price.
Our internal
control over financial reporting and our disclosure controls and procedures have
been ineffective in the past. We have taken steps to improve our
disclosure controls and procedures and our internal control over financial
reporting, and as of October 31, 2010, our chief executive officer and chief
financial officer concluded that our disclosure controls and procedures and
internal control over financial reporting were effective. However,
there is no assurance that our disclosure controls and procedures will remain
effective or that there will be no material weaknesses in our internal control
over financial reporting in the future. Additionally, as a result of
the historical material weaknesses in our internal control over financial
reporting and the historical ineffectiveness of our disclosure controls and
procedures, current and potential stockholders could lose confidence in our
financial reporting, which would harm our business and the trading price of our
stock.
Our
executive officers and directors can exert significant influence over us and may
make decisions that do not always coincide with the interests of other
stockholders.
As of
January 27, 2011, our officers and directors and their affiliates, in the
aggregate, beneficially own approximately 13.8% of the outstanding shares of our
common stock. As a result, such persons, acting together, have the ability to
substantially influence all matters submitted to our stockholders for approval,
including the election and removal of directors, any merger, consolidation or
sale of all or substantially all of our assets, an increase in the number of
shares authorized for issuance under our stock option plans, and to control our
management and affairs. Accordingly, such concentration of ownership may have
the effect of delaying, deferring or preventing a change in or discouraging a
potential acquirer from making a tender offer or otherwise attempting to obtain
control of our business, even if such a transaction would be beneficial to other
stockholders.
Sales
of additional equity securities may adversely affect the market price of our
common stock and your rights in us may be reduced.
We expect
to continue to incur product development and selling, general and administrative
costs, and to satisfy our funding requirements, we will need to sell additional
equity securities, which may be subject to registration rights and warrants with
anti-dilutive protective provisions. The sale or the proposed sale of
substantial amounts of our common stock in the public markets may adversely
affect the market price of our common stock and our stock price may decline
substantially. Our stockholders may experience substantial dilution and a
reduction in the price that they are able to obtain upon sale of their shares.
Also, new equity securities issued may have greater rights, preferences or
privileges than our existing common stock.
Additional
authorized shares of common stock available for issuance may adversely affect
the market.
We are
authorized to issue 500,000,000 shares of our common stock. As of January 27,
2011, we had 210,645,862 shares of our common stock issued and outstanding,
excluding shares issuable upon exercise of our outstanding warrants and options.
As of October 31, 2010, we had outstanding options to purchase 26,467,424 shares
of our common stock at a weighted average exercise price of approximately $0.16
per share and outstanding warrants to purchase 87,336,687 shares of our common
stock (excluding Optimus warrants in the amount of 15,802,941), with exercise
prices ranging from $0.15 to $0.29 per share. Pursuant to our 2004, 2005 and
2009 Stock Option Plans, we have 2,381,525, 5,600,000 and 20,000,000 shares of
common stock reserved respectively, for issuance under the plans. In addition,
as of January 27, 2011, we have 62,500, 505,333 and 640,268 of these options
available for issuance under the 2004, 2005 and 2009 Stock Option Plans,
respectively. To the extent the shares of common stock are issued or options and
warrants are exercised, holders of our common stock will experience dilution. In
addition, in the event of any future financing of equity securities or
securities convertible into or exchangeable for, common stock, holders of our
common stock may experience dilution. Moreover, the above-mentioned warrants to
purchase our common stock are subject to “full ratchet” anti-dilution protection
upon certain equity issuances below $0.15 per share (as may be further
adjusted).
We
are able to issue shares of preferred stock with rights superior to those of
holders of our common stock. Such issuances can dilute the tangible net book
value of shares of our common stock.
Our
Amended and Restated Certification of Incorporation provides for the
authorization of 5,000,000 shares of “blank check” preferred stock. Pursuant to
our Amended and Restated Certificate of Incorporation, our board of directors is
authorized to issue such “blank check” preferred stock with rights that are
superior to the rights of stockholders of our common stock, at a purchase price
then approved by our board of directors, which purchase price may be
substantially lower than the market price of shares of our common stock, without
stockholder approval. Such issuances can dilute the tangible net book value of
shares of our common stock.
We
do not intend to pay cash dividends.
We have
not declared or paid any cash dividends on our common stock, and we do not
anticipate declaring or paying cash dividends for the foreseeable future. Any
future determination as to the payment of cash dividends on our common stock
will be at our board of directors’ discretion and will depend on our financial
condition, operating results, capital requirements and other factors that our
board of directors considers to be relevant.
Item
2. Properties .
Our
corporate offices are currently located at a biotech industrial park located at
675 U.S. Highway One, North Brunswick, NJ 08902. Our current Lease
Amendment Agreement dated as of March 1, 2008 with the New Jersey Economic
Development Authority will continue on a monthly basis for two research and
development laboratory units (total of 1,600 s.f.) and one office (total of 655
s.f.). We believe our facility will be sufficient for our near term
purposes and the facility offers additional space for the foreseeable
future. Our monthly payment on this facility is approximately $6,300 per
month. In the event that our facility should, for any reason, become
unavailable, we believe that alternative facilities are available at competitive
prices.
27
Item 3. Legal
Proceedings.
As of the
date hereof, there are no material pending legal proceedings to which we are a
party or of which any of our property is the subject. In the ordinary
course of our business we may become subject to litigation regarding our
products or our compliance with applicable laws, rules, and
regulations.
Item
4. Removed and Reserved.
PART
II
Item
5. Market For Our Common Stock and Related Stockholder Matters.
Since
July 28, 2005, our common stock has been quoted on the OTC Bulletin Board under
the symbol ADXS.OB. The following table shows, for the periods indicated,
the high and low bid prices per share of our common stock as reported by the OTC
Bulletin Board. These bid prices represent prices quoted by broker-dealers
on the OTC Bulletin Board. The quotations reflect inter-dealer prices,
without retail mark-up, mark-down or commissions, and may not represent actual
transactions.
Fiscal 2010
|
Fiscal 2009
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
First
Quarter (November 1-January 31)
|
$
|
0.19
|
$
|
0.02
|
$
|
0.06
|
$
|
0.01
|
||||||||
Second
Quarter (February 1- April 30)
|
$
|
0.26
|
$
|
0.12
|
$
|
0.05
|
$
|
0.02
|
||||||||
Third
Quarter (May 1 - July 31)
|
$
|
0.25
|
$
|
0.17
|
$
|
0.21
|
$
|
0.04
|
||||||||
Fourth
Quarter (August 1 - October 31)
|
$
|
0.19
|
$
|
0.10
|
$
|
0.19
|
$
|
0.06
|
As of
January 27, 2011, there were approximately 87 stockholders of record. Because
shares of our common stock are held by depositaries, brokers and other nominees,
the number of beneficial holders of our shares is substantially larger than the
number of stockholders of record. Based on information available to us, we
believe there are approximately 3,500 beneficial owners of our shares of our
common stock in addition to the stockholders of record. On January 27, 2011, the
last reported sale price per share for our common stock as reported by the OTC
Bulletin Board was $0.15.
We have
not declared or paid any cash dividends on our common stock, and we do not
anticipate declaring or paying cash dividends for the foreseeable future. We are
not subject to any legal restrictions respecting the payment of dividends,
except that we may not pay dividends if the payment would render us insolvent.
Any future determination as to the payment of cash dividends on our common stock
will be at our board of directors’ discretion and will depend on our financial
condition, operating results, capital requirements and other factors that our
board of directors considers to be relevant.
Holders
of Series B preferred stock will be entitled to receive dividends, which will
accrue in shares of Series B preferred stock on an annual basis at a rate equal
to 10% per annum from the issuance date. Accrued dividends will be payable upon
redemption of the Series B preferred stock or upon the liquidation, dissolution
or winding up of our company. The Series B preferred stock ranks, with respect
to dividend rights and rights upon liquidation:
·
|
senior
to our common stock and any other class or series of preferred stock
(other than Series A preferred stock or any class or series of preferred
stock that we intend to cause to be listed for trading or quoted on
Nasdaq, NYSE Amex or the New York Stock Exchange);
|
|
·
|
pari
passu with any outstanding shares of our Series A preferred stock (none of
which are issued and outstanding as of the date hereof);
and
|
|
·
|
junior
to all of our existing and future indebtedness and any class or series of
preferred stock that we intend to cause to be listed for trading or quoted
on Nasdaq, NYSE Amex or the New York Stock
Exchange.
|
Equity
Compensation Plan Information
The
following table provides information regarding the status of our existing equity
compensation plans at October 31, 2010:
28
Plan category
|
Number of shares of
common stock to be
issued on exercise of
outstanding options,
warrants and rights
|
Weighted-
average
exercise price
of outstanding
options,
warrants and
rights
|
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in the
previous columns)
|
|||||||||
Equity
compensation plans approved by security holders
|
26,467,424
|
$
|
0.16
|
1,208,101
|
||||||||
Equity
compensation plans not approved by security holders
|
-
|
$
|
-
|
-
|
||||||||
Total
|
26,467,424
|
$
|
0.16
|
1,208,101
|
ITEM
6. Selected Financial Data.
Not
required.
ITEM
7. Management’s Discussion and Analysis of Financial Condition and Results of
Operations.
This
Management’s Discussion and Analysis of Financial Conditions and Results of
Operations and other portions of this report contain forward-looking information
that involves risks and uncertainties. Our actual results could differ
materially from those anticipated by the forward-looking information.
Factors that may cause such differences include, but are not limited to,
availability and cost of financial resources, product demand, market acceptance
and other factors discussed in this report under the heading “Risk
Factors”. This Management’s Discussion and Analysis of Financial
Conditions and Results of Operations should be read in conjunction with our
financial statements and the related notes included elsewhere in this
report.
Overview
Advaxis
is a development stage biotechnology company with the intent to develop safe and
effective cancer vaccines that utilize multiple mechanisms of immunity. We are
developing a live Listeria vaccine technology
under license from Penn which can be engineered to secrete a variety of
different protein sequences containing tumor-specific antigens leading to the
development of a variety of different products. We believe this vaccine
technology is capable of stimulating the body’s immune system to process and
recognize the antigen that has a therapeutic effect upon cancer. We believe this
to be a broadly enabling platform technology that can be applied to the
treatment of many types of cancers, infectious diseases and auto-immune
disorders.
The
discoveries that underlie this innovative technology are based upon the work of
Yvonne Paterson, Ph.D., Professor of Microbiology at Penn. This technology
involves the creation of genetically engineered Listeria that stimulate the
innate immune system and induce an antigen-specific immune response involving
both arms of the adaptive immune system. In addition, this technology supports,
among other things, the immune response by altering tumors to make them more
susceptible to immune attack, stimulating the development of specific blood
cells that underlie a strong therapeutic immune response.
We have
no customers. Since our inception in 2002, we have focused our development
efforts upon understanding our technology and establishing a product development
pipeline that incorporates this technology in the therapeutic cancer vaccines
area targeting cervical, head and neck, prostate, breast, and a pre cancerous
indication of CIN. Although no products have been commercialized to date,
research and development and investment continues to be placed behind the
pipeline and the advancement of this technology. Pipeline development and the
further exploration of the technology for advancement entail risk and expense.
We anticipate that our ongoing operational costs will increase significantly
when we begin several of our clinical trials.
29
The
following factors, among others, could cause actual results to differ from those
indicated in the above forward-looking statements: increased length and scope of
our clinical trials, failure to recruit patients, increased costs related to
intellectual property related expenses, increased cost of manufacturing and
higher consulting costs. These factors or additional risks and uncertainties not
known to us or that we currently deem immaterial may impair business operations
and may cause our actual results to differ materially from any forward-looking
statement.
Although
we believe the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance
or achievements.
We expect
our future sources of liquidity to be primarily debt and equity capital raised
from investors, as well as licensing fees and milestone payments in the event we
enter into licensing agreements with third parties, and research collaboration
fees in the event we enter into research collaborations with third parties. In
August 2009, we received an NIH grant for $210,739 for the development of a dual
vector capable of attacking two immunologic targets simultaneously. In
October 2010, we received notice that the company was awarded an IRS grant under
the Qualified Therapeutic Discovery Program for approximately $245,000. This
amount was included in grant revenue for the year ending October 31, 2010. The
company received the funds in November 2010.
On
January 15, 2010 we received $278,978 from the New Jersey Economic Development
Authority. Under the State of New Jersey NOL Transfer Program for small business
we received this cash amount from the sale of our State Net Operating Losses
through December 31, 2008 and our research tax credit for fiscal years 2007 and
2008. The company plans to sell is Net Operating Losses and research tax
credits for the 2009 fiscal year under the same State of New Jersey Program for
small business.
If
additional capital were raised through the sale of equity or convertible debt
securities, the issuance of such securities would result in additional dilution
to our existing stockholders. If we fail to raise a significant amount of
capital, we may need to significantly curtail operations or cease operations in
the near future. Any sale of our common stock or issuance of rights to acquire
our common stock below $0.15 per share (as may be further adjusted) will trigger
a significant dilution due to the anti-dilution protection provisions in certain
of our outstanding warrants and debt instruments.
Plan
of Operations
If we are
successful in our financing plans we intend to use the majority of the proceeds
to complete our two Phase II trials of ADXS11-001, our initial Listeria construct targeting
diseases caused by the Human Papilloma Virus (HPV). One is a 120 patient U.S.
study in CIN, the other, a 110 patient Indian study in highly advanced cervical
cancer. We also anticipate using the funds to further our preclinical and
clinical, research and development efforts in developing product candidates in
prostate cancer, breast and brain cancer and for general and administrative
activities.
During
the next 24 months, our strategic focus will be to achieve the following goals
and objectives:
·
|
Complete
our two Phase II clinical studies of ADXS11-001 in the therapeutic
treatment of CIN and late-stage cervical cancer;
|
|
|
·
|
Begin
an additional Phase II clinical trial of our ADXS11-001 candidate in the
treatment of advanced cervical cancer with the Gynecologic Oncology Group(
GOG), largely underwritten by the National Cancer
Institute(NCI);
|
|
·
|
Continue
to focus on our collaboration with the CRUK to carry out our Phase I/II
clinical trial of our ADXS11-001 candidate in the treatment of head and
neck cancer entirely underwritten by the CRUK;
|
|
·
|
Continue
to support our Collaborative Research and Development Agreement (CRADA)
with the US Department of Homeland Security to develop vaccines for the
protection of our food supply;
|
·
|
Continue
to execute our Canine Osteosarcoma Study with the University of
Pennsylvania with relevance to human adolescents;
|
|
·
|
To
support our new CRADA with the National Cancer Institute to understand the
mechanisms of action of attenuated Listeria vaccines, to
develop new vaccines, and to advance them to clinical
testing.
|
|
·
|
Continue
to further our structured collaboration with the University of British
Columbia on innovative uses of Listeria constructs in
infectious disease, parasitical disease and neonatal
immunity;
|
|
·
|
Continue
to develop strategic and development collaborations with academic
laboratories and potential commercial partners;
|
|
|
·
|
Continue
the development work necessary to bring ADXS31-142 in the therapeutic
treatment of prostate cancer into clinical trials, and initiate that trial
provided that funding is available;
|
|
·
|
Continue
the development work necessary to bring ADXS31-164 in the therapeutic
treatment of breast, brain, and other cancers into clinical trials, and
initiate that trial when and if funding is available;
and
|
|
·
|
Continue
the preclinical development of other product candidates, as well as
continue research to expand our technology
platform.
|
Our
projected annual staff, overhead, laboratory and nonclinical expenses are
estimated to be approximately $4.1 million starting in fiscal year beginning
November 1, 2010. The cost of our Phase II clinical studies in therapeutic
treatment of CIN and late stage cervical cancer is estimated to be
approximately $11.2 million over the estimated 30 month period of the trial.
While approximately $4 million has already been paid towards these costs, we
must raise additional funds in order to complete the Phase II trials. If we can
raise additional funds we intend to commence the clinical work in prostate
cancer by late 2011 and breast and brain cancer by late 2011. The timing and
estimated costs of these projects are difficult to predict.
30
If the
clinical progress continues to be successful and the value of our company
increases, we may attempt to accelerate the timing of the required financing
and, conversely, if the trial or trials are not successful we may slow our
spending and defer the timing of additional financing. While we will attempt to
attract a corporate partnership and grants, we have not assumed the receipt of
any additional financial resources in our cash planning.
We
anticipate that our research and development expenses will increase
significantly as a result of our expanded development and commercialization
efforts related to clinical trials, product development, and development of
strategic and other relationships required ultimately for the licensing,
manufacture and distribution of our product candidates. We regard three of our
product candidates as major research and development projects. The timing, costs
and uncertainties of those projects are as follows:
ADXS11-001
- Phase II CIN Trial Summary Information (U.S.: target enrollment: 120
Patients)
·
|
Cost
incurred through October 31, 2010: approximately $2.8
million;
|
|
|
·
|
Estimated
future clinical costs approximates $4.7 million:
|
|
·
|
Anticipated
Timing: commenced in March 2010 (with patient dosing commencing in June
2010); reporting of low dose portion in late 2011, completion August
2012 or beyond
|
Uncertainties:
·
|
The
FDA (or relevant foreign regulatory authority) may place the project on
clinical hold or stop the project;
|
|
·
|
One
or more serious adverse events in otherwise healthy patients enrolled in
the trial;
|
|
·
|
Difficulty
in recruiting patients;
|
|
|
·
|
Delays
in the program;
|
|
·
|
Material
cash flows; and
|
|
·
|
Anticipated
Timing: Unknown at this stage and dependent upon successful trials,
adequate fund raising, entering a licensing deal or pursuant to a
marketing collaboration subject to regulatory approval to market and sell
the product.
|
ADXS11-001 - Phase II
Cervical Cancer Trial Summary Information (India: target enrollment: 110
Patients)
·
|
Cost
incurred through October 31, 2010: approximately $1.4
million;
|
|
·
|
Estimated
future clinical costs: approximates $2.3;
|
|
|
·
|
Anticipated
Timing: start July-August; reporting of survival beginning in late summer
2011, completion August 2012 or
beyond.
|
Additional
Uncertainties:
·
|
One
or more serious adverse events in these late stage cancer patients
enrolled in the trial; and
|
ADXS11-001 - Phase II Cancer
of the Cervix Trial Summary Information (U.S. GOG/NCI: target enrollment:
up to 63 Patients)
·
|
Cost
incurred through October 31, 2010: Minimal;
|
|
|
·
|
Estimated
future clinical costs: $500,000 (NCI underwriting costs of $4.0 million to
$5.0 million);
|
|
·
|
Anticipated
Timing: The GOG of the NCI has agreed to conduct a study which we expect
will commence in 2011.
|
Additional
Uncertainties:
·
|
Unknown
timing in recruiting patients and conducting the study based on GOG/NCI
controlled study;
|
|
|
·
|
Delays
in the program; and
|
ADXS11-001 - Phase II Cancer
of the Head and Neck Trial Summary Information (U.K. CRUK: target enrollment: up
to 45 Patients)
·
|
Cost
incurred through October 31, 2010: Minimal;
|
|
|
·
|
Estimated
future clinical costs: Approximates $50,000 (CRUK to underwrite costs of
$3.0 million to $4.0 million);
|
|
·
|
Anticipated
Timing: The CRUK is funding a study of up to 45 patients at 3 UK
facilities that we expect will commence in
2011.
|
31
Additional
Uncertainties:
·
|
Unknown
timing in recruiting patients and conducting the study based on CRUK
controlling the study;
|
||
·
|
Delays
in the program; and
|
ADXS31-142
- GMP Production and Phase I Trial Summary Information ( Prostate Cancer: target
enrollment: 30 Patients)
·
|
Cost
incurred to date: Minimal
|
|
|
·
|
Estimated
future costs: $3.5 million;
|
|
·
|
Anticipated
Timing: to be determined.
|
Additional
Uncertainties:
·
|
FDA
(or foreign regulatory authority) may not approve the
study.
|
ADXS31-164 - Phase I trial
Summary Information (Breast or Brain Cancer: target enrollment: 24
Patients)
·
|
Cost
incurred to date: Minimal;
|
|
|
·
|
Estimated
future costs: To be determined;
|
|
·
|
Anticipated
Timing: To be determined.
|
Additional Uncertainties:
See ADXS31-164 (see prior Uncertainties)
Results
of Operations
Fiscal
Year 2010 Compared to Fiscal Year 2009
Revenue
Revenue
increased by approximately $478,791to $508,481for the year ended October 31,
2010 as compared with $29,690 for the same period a year ago, representing grant
revenue received by the company.
Research
and Development Expenses
Research
and development expenses increased by approximately $2,589,000 to $4,904,298
for the year ended October 31, 2010 as compared with $2,315,557 for the
same period a year ago. This is almost all attributable to clinical trial
expenses, which increased significantly in the current year due to our clinical
trial activity in the United States and India, initiated during the first
fiscal quarter of 2010.
We
anticipate a significant increase in R&D expenses as a result of expanded
development and commercialization efforts primarily related to clinical trials
and product development. In addition, expenses will be incurred in the
development of strategic and other relationships required to license manufacture
and distribute our product candidates.
General
and Administrative Expenses
General
and administrative expenses increased by approximately $829,000 or 22%, to
$3,530,198 for the year ended October 31, 2010 as compared with $2,701,133 for
the same period a year ago. This is primarily attributable to overall
compensation expense being higher in the current year resulting from additional
employees, costs related to a former employee and stock-based non cash
compensation resulting from the issuance of 750,000 shares of the company’s
common stock pursuant to an executive’s employment agreement with the
company. Overall professional fees also increased in the current year as a
result of higher recruiting, legal and accounting fees in 2010 compared with a
year ago. In addition, consulting and travel fees increased in the current
year primarily due to increased efforts by the Company to present its scientific
and business plans. The company also recognized approximately $206,000 in
non-cash warrant expense, vs. $0 in the prior year, as a result of additional
warrants that were issued to bridge note holders in September 2010. All of the
above increases were somewhat offset by higher offering expenses in 2009 that
did not repeat in the current year.
Interest
Expense/Income
In the
year ending October 31, 2010, net interest expense increased by approximately $3
million to $3,814,863 compared to $851,008 for the same period a year ago,
primarily due to the sale of Bridge Notes during the third and fourth fiscal
quarters of 2009 and in the year ending October 31, 2010. Additionally, the debt
discount, warrant liabilities and embedded derivatives related to the Bridge
Notes are recorded as a liability on the balance sheet and are amortized to
interest expense over the life of the Bridge Notes. Interest income of
approximately $80,000 was the result of interest earned from the Optimus notes
receivable. These notes are classified in the equity section of the balance
sheet as a stock subscription receivable.
32
Changes
in Fair Values
The
change in fair value of the common stock warrant liability and embedded
derivative liability increased income by approximately $446,000 for the year
ending October 31, 2010 compared to approximately $5.8 million the same period a
year ago. During the 2009 period the Company recorded income as the fair value
of its warrant and embedded derivative liability decreased primarily due to a
change in management’s assumptions used to calculate the fair value of its
warrants and embedded derivatives at October 31, 2009. This change in assumption
substantially decreased both the number of warrants and related BSM values used
in calculating the warrant liability, therefore decreasing the overall warrant
and embedded derivative liability at October 31, 2009. For the first nine months
of the year ending October 31, 2010, the BSM values associated with these
warrants and embedded derivatives increased resulting from the increase in the
price of Advaxis common stock, from $0.135 at October 31, 2009 to $0.17 at July
31, 2010. However, from July 31 to October 31, 2010, the number of outstanding
warrants increased due to a decrease in their exercise price and the BSM values
decreased due to a decline in the price of Advaxis common stock, resulting in
the Company recording income for the full year.
Potential
future increases or decreases in our stock price will result in increased or
decreased warrant and embedded derivative liabilities, respectively, on our
balance sheet and therefore increased expenses being recognized in our statement
of operations in future periods.
For the
year ending October 31, 2010, the Company recorded income of approximately
$124,000 on the non-cash gain on the early retirement of certain Bridge
Notes.
Income
Tax Benefit
For the
year ending October 31, 2010, other income decreased by approximately $643,000,
to approximately $279,000 in income from approximately $922,000 a year ago,
primarily due to the 2009 period NOL being the first time we received funds from
the program and covered all prior years NOLs from our inception whereas
Fiscal 2010 covered only the current year’s NOL and prior two years of the
research tax credit.
Liquidity
and Capital Resources
Our
limited capital resources and operations to date have been funded primarily with
the proceeds from public, private equity and debt financings, NOL tax sales and
income earned on investments and grants. We have sustained losses from
operations in each fiscal year since our inception, and we expect losses to
continue for the indefinite future, due to the substantial investment in
research and development. As of October 31, 2010 and 2009, we had an
accumulated deficit of $27,416,000 and $16,603,800, respectively, and
shareholders’ deficiency of $14,802,631 and $15,733,328 respectively. Based on
our available cash of approximately $108,000 on October 31, 2010, we do not have
adequate cash on hand to cover our anticipated expenses for the next 12 months.
If we fail to raise a significant amount of capital, we may need to
significantly curtail or cease operations in the near future. These
conditions have caused our auditors to raise substantial doubt about our ability
to continue as a going concern. Consequently, the audit report prepared by
our independent public accounting firm relating to our financial statements for
the year ended October 31, 2010 included a going concern explanatory
paragraph.
Our
business will require substantial additional investment that we have not yet
secured, and our failure to raise capital and/or pursue partnering opportunities
will materially adversely affect our business, financial condition and results
of operations. We expect to spend substantial additional sums on the continued
administration and research and development of proprietary products and
technologies, including conducting clinical trials for our product candidates,
with no certainty that our products will become commercially viable or
profitable as a result of these expenditures. Further, we will not have
sufficient resources to develop fully any new products or technologies unless we
are able to raise substantial additional financing on acceptable terms or secure
funds from new partners. We cannot be assured that financing will be available
at all. Any additional investments or resources required would be
approached, to the extent appropriate in the circumstances, in an incremental
fashion to attempt to cause minimal disruption or dilution. Any additional
capital raised through the sale of equity or convertible debt securities will
result in dilution to our existing stockholders. No assurances can be
given, however, that we will be able to achieve these goals or that we will be
able to continue as a going concern.
Pursuant
to the Series B purchase agreement, Optimus has agreed to purchase, upon the
terms and subject to the conditions set forth therein and described below, up to
$7.5 million of our newly authorized, non-convertible, redeemable Series B
preferred stock at a price of $10,000 per share. Under the terms of
the Series B purchase agreement we may from time to time until July 19, 2013,
present Optimus with a notice to purchase a specified amount of Series B
preferred stock. Subject to satisfaction of certain closing
conditions, Optimus is obligated to purchase such shares of Series B preferred
stock on the 10th trading day after the date of the notice. We will
determine, in our sole discretion, the timing and amount of Series B preferred
stock to be purchased by Optimus, and may sell such shares in multiple tranches.
Optimus will not be obligated to purchase the Series B preferred stock upon our
notice (i) in the event the closing price of our common stock during the nine
trading days following delivery of our notice falls below 75% of the closing
price on the trading day prior to the date such notice is delivered to Optimus
or (ii) to the extent such purchase would result in Optimus and its affiliates
beneficially owning more than 9.99% of our outstanding common
stock.
As of
October 31, 2010, we had issued and sold 289 shares of Series B preferred stock
to Optimus pursuant to the terms of the Series B purchase agreement. We received
net proceeds of $2,545,000 from this transaction. The aggregate purchase price
for the Series B preferred stock was $2.89 million. As of October 31,
2010, under the terms of the Series B purchase Agreement, Optimus remained
obligated, from time to time until July 19, 2013, to purchase up to an
additional 461 shares of Series B preferred stock at a purchase price of $10,000
per share upon notice from us to Optimus, if certain conditions set forth in the
Series B purchase agreement are satisfied. Among these conditions, we
must have a sufficient number of registered shares underlying a warrant issued
to an affiliate of Optimus. We will likely need to register
additional warrant shares in order to require Optimus to purchase the remaining
shares of Series B preferred stock.
In
connection with the Series B preferred equity financing, an affiliate of Optimus
was granted on July 19, 2010 a warrant to purchase up to 40,500,000 shares of
our common stock at an exercise price of $0.25 to be adjusted in connection with
the draw down of each tranche. On August 13, 2010, the draw down date
of the first tranche of Series B preferred stock, the affiliate of Optimus
exercised a portion of the warrant to purchase 9,847,059 shares of common stock
at an adjusted exercise price of $0.17 per share. On September 28,
2010, the draw down date of the second tranche of Series B preferred stock, the
affiliate of Optimus exercised a portion of the warrant to purchase 14,850,000
shares of common stock at an exercise price of $0.15 per share. As
permitted by the terms of such warrant, the aggregate exercise price of
$3,901,500 for the first tranche and second tranche, received by us is payable
pursuant to four year full recourse promissory notes each bearing interest at
the rate of 2% per year. As of October 31, 2010, 15,802,941
warrants remained outstanding.
On
September 24, 2009, we entered into a preferred stock purchase agreement with
Optimus, which we refer to as the Series A purchase agreement, pursuant to which
Optimus agreed to purchase, upon the terms and subject to the conditions set
forth therein, up to $5.0 million of Series A preferred stock at a price of
$10,000 per share. As of May 13, 2010, all 500 shares of Series A
preferred stock were issued and sold to Optimus. On July 19, 2010, we
issued 500 shares of Series B preferred stock to Optimus, which we refer to as
the Series B exchange shares, in exchange for the 500 shares of Series A
preferred stock so that all shares of our preferred stock held or subsequently
purchased by Optimus under the Series B purchase agreement would be redeemable
upon substantially identical terms. In connection with the Series A
preferred equity financing, an affiliate of Optimus was granted on September 24,
2009 a warrant to purchase up to 33,750,000 shares of our common stock at an
exercise price of $0.20 to be adjusted in connection with the draw down of each
tranche. On January 11, 2010, the draw down date of the first
tranche, the affiliate of Optimus exercised a portion of the warrant to purchase
11,563,000 shares of common stock at an adjusted exercise price of $0.17 per
share. On March 29, 2010, the draw down date of the second tranche,
the affiliate of Optimus exercised a portion of the warrant to purchase
14,580,000 shares of common stock at an exercise price of $0.20 per
share. On May 13, 2010, the draw down date of the final tranche, the
affiliate of Optimus exercised the remainder of the warrant to purchase
7,607,000 shares of common stock at an adjusted exercise price of $0.18 per
share. In each case, we agreed with Optimus and its affiliate to
waive certain terms and conditions in the Series A purchase agreement and the
warrant in order to permit the affiliate of Optimus to exercise the warrant at
such adjusted exercise prices prior to the closing of the purchase of the Series
A preferred stock and acquire beneficial ownership of more than 4.99% of our
common stock on the date of each exercise. As permitted by the terms
of such warrant, the aggregate exercise prices of $1,965,710, $2,916,000 and
$1,369,260 for the first tranche, second tranche and final tranche,
respectively, received by us is payable pursuant to three separate four year
full recourse promissory notes each bearing interest at the rate of 2% per
year. In addition, in connection with the draw down of the final
tranche, we issued an additional warrant to an affiliate of Optimus to purchase
up to 2,818,000 shares of common stock at an exercise price of $0.18 per share,
subject to customary anti-dilution adjustments (the exercise price of which may
also be paid at the option of the affiliate of Optimus in cash or by its
issuance of a promissory note on the same terms as the foregoing promissory
notes). The foregoing promissory notes are not due or payable at any
time that (a) we are in default of under the Series A preferred stock purchase
agreement, any loan agreement or other material agreement or (b) there are any
Series B exchange shares issued or outstanding.
On June 18,
2009, we completed the senior bridge financing. The senior bridge
financing was a private placement with certain accredited investors pursuant to
which we issued (i) senior bridge notes in the aggregate principal face amount
of $1,131,353, for an aggregate net purchase price of $961,650 and (ii) senior
bridge warrants to purchase 2,404,125 shares of our common stock at an exercise
price of $0.20 per share (prior to giving effect to anti-dilution adjustments
which have subsequently reduced the exercise price to $0.15 per share), subject
to adjustments upon the occurrence of certain events. Each of the
senior bridge notes were issued with an original issue discount of 15% and were
convertible into shares of our common stock in certain
circumstances. The senior bridge notes had an initial maturity date
of December 31, 2009. During January and February 2010, we repaid
$834,852 of the $1,131,353 in face value of our senior bridge
notes. In addition, holders of the remaining $296,501 of our senior
bridge notes agreed to extend the maturity dates from December 31, 2009 to
periods into February and March 2010. We have agreed to issue additional
consideration, including warrants to senior bridge note holders, all of whom
agreed to extend the maturity period beyond December 31, 2009. As of
October 31, 2010, approximately $89,000 remained outstanding under the senior
bridge notes.
During
the twelve months ended October 31, 2010, we issued to certain accredited
investors (i) junior unsecured convertible promissory notes in the aggregate
principal face amount of approximately $1,462,000 for an aggregate net purchase
price of approximately $1,255,000 and (ii) warrants to purchase 3,270,955 shares
of our common stock at original exercise prices ranging from $0.17 to $0.25 per
share, subject to adjustments upon the occurrence of certain events. The
bridge notes were issued with original issue discounts ranging from 6% to 18%
and are convertible into shares of our common stock. These notes mature on
or before May 31, 2011.
As a
result of anti-dilution provisions in the warrants issued in connection with the
equity financings completed in October 2007 triggered by the Optimus transaction
in September 2010, we agreed to issue an additional 616,136 warrants to the
above investors at an exercise price of $0.15 per share (formerly $0.17 to $0.25
per share).
33
During
the twelve months ended October 31, 2010, the company repaid a total of
approximately $1,542,000 in principal value of bridge notes and converted
$2,420,000 in principal value of bridge notes into 14,237,489 shares of our
common stock. At October 31, 2010, approximately $777,000 in principal
value of bridge notes remains and is classified as a current liability on the
balance sheet. The indebtedness represented by these bridge notes is
expressly subordinate to our currently outstanding senior secured indebtedness
(approximately $89,000 at October 31, 2010).
As a
result of anti-dilution protection provisions contained in certain of our
outstanding warrants, we (i) reduced the exercise price from $0.20 to $0.17 per
share in January 2010 and further reduced the exercise price from $0.17 to $0.15
per share in September 2010 with respect to substantially all the warrants to
purchase shares of our common stock and (ii) correspondingly adjusted the amount
of warrants shares issuable such that approximately 11.4 million additional
warrant shares are issuable related to the January 2010 repricing and
approximately 10.4 million additional warrant shares are issuable related to the
September 2010 repricing. As of October 31, 2010, approximately 87.3
million warrant shares are currently exercisable at $0.15 per
share.
On
September 22, 2008 we entered into a note purchase agreement with our Chief
Executive Officer, Thomas A. Moore, pursuant to which we agreed to sell to Mr.
Moore, from time to time, Moore Notes (“the Moore Agreement”). The Notes
have been amended from time to time. During 2010, we agreed to amend the
terms of the Moore Notes such that Mr. Moore may elect, at his option, to
receive accumulated interest thereon (of which we paid $130,000 on March 17,
2010) and that we will begin to make installment payments on the outstanding
principal beginning on April 15, 2010 (of which $250,000 was paid during the
year ended October 31, 2010); provided, however, that the balance of the
principal will be repaid in full as a result of either (i) consummation of our
next equity financing resulting in gross proceeds to the company of at least
$6.0 million or (ii) default by the company as defined under the terms of the
Moore Agreement. As of October 31, 2010, the company was not in default under
the terms of the Moore Agreement. Additionally, we agreed to retain $200,000 of
the repayment amount for investment in our next equity financing (Mr. Moore
exchanged debt with the principal amount of $200,000 into 1,176,471 shares of
the Company’s common stock in May 2010).
The Moore
Notes bear interest at a rate of 12% per annum and may be prepaid in whole or in
part at our option without penalty at any time prior to maturity. As of
October 31, 2010, approximately $600,000 in notes were outstanding and payable
to Mr. Moore.
In October
2010, we received an IRS grant under the Qualified Therapeutic Discovery Program
for approximately $245,000. The company plans to sell is Net Operating
Losses and research tax credits for the 2009 fiscal year under the same State of
New Jersey NOL Transfer Program for small business.
Off-Balance
Sheet Arrangements
As of
October 31, 2010, we had no off-balance sheet arrangements, other than our lease
for space. There were no changes in significant contractual obligations during
the year ended October 31, 2010.
Critical
Accounting Estimates
The
preparation of financial statements in accordance with GAAP accepted in the U.S.
requires management to make estimates and assumptions that affect the reported
amounts and related disclosures in the financial statements. Management
considers an accounting estimate to be critical if:
·
|
It
requires assumption to be made that were uncertain at the time the
estimate was made, and
|
·
|
Changes
in the estimate of difference estimates that could have been selected
could have material impact in our results of operations or financial
condition.
|
Actual
results could differ from those estimates and the differences could be material.
The most significant estimates impact the following transactions or account
balances: stock compensation, warrant valuation, impairment of intangibles,
dilution caused by ratchets in the warrants and other
agreements.
34
Share-Based Payment. We
record compensation expense associated with stock options in accordance with
Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
(“ASC”) Topic 718, Stock Compensation (formerly, FASB Statement 123R). We
adopted the modified prospective transition method provided under SFAS No. 123R.
Under this transition method, compensation expense associated with stock options
recognized in the first quarter of fiscal year 2007, and in subsequent quarters,
includes expense related to the remaining unvested portion of all stock option
awards granted prior to April 1, 2006, the estimated fair value of each option
award granted was determined on the date of grant using the Black-Scholes option
valuation model, based on the grant date fair value estimated in accordance with
the original provisions of SFAS No. 123.
We
estimate the value of stock options awards on the date of grant using the
Black-Scholes-Merton option-pricing model. The determination of the fair value
of the share-based payment awards on the date of grant is affected by our stock
price as well as assumptions regarding a number of complex and subjective
variables. These variables include our expected stock price volatility over the
term of the awards, expected term, risk-free interest rate, expected dividends
and expected forfeiture rates. The forfeiture rate is estimated using historical
option cancellation information, adjusted for anticipated changes in expected
exercise and employment termination behavior. Our outstanding awards do not
contain market or performance conditions; therefore we have elected to recognize
share based employee compensation expense on a straight-line basis over the
requisite service period.
If
factors change and we employ different assumptions in the application of ASC 718
in future periods, the compensation expense that we record under ASC 718
relative to new grants may differ significantly from what we have recorded in
the current period. There is a high degree of subjectivity involved when using
option-pricing models to estimate share-based compensation under ASC 718.
Consequently, there is a risk that our estimates of the fair values of our
share-based compensation awards on the grant dates may bear little resemblance
to the actual values realized upon the exercise, expiration, early termination
or forfeiture of those share-based payments in the future. Employee stock
options may expire worthless or otherwise result in zero intrinsic value as
compared to the fair values originally estimated on the grant date and reported
in our financial statements. Alternatively, value may be realized from these
instruments that are significantly in excess of the fair values originally
estimated on the grant date and reported in our financial
statements.
Warrants
Warrants
were issued in connection with the equity financings completed in October 2007,
the sale of preferred stock and our Bridge Notes issued from June 2009 through
November 2010. At October 31, 2010, we estimated the fair value of the
outstanding instruments using the Black-Scholes valuation model, which takes
into account a variety of factors, including historical stock price volatility,
risk-free interest rates, remaining term and the closing price of our common
stock. Changes in assumptions used to estimate the fair value of these
derivative instruments could result in a material change in the fair value of
the instruments. We believe the assumptions used to estimate the fair values of
the warrants are reasonable.
As of
October 31, 2010, we had outstanding warrants to purchase 103,139,628 shares of
our common stock (adjusted for anti-dilution provisions to-date) including
approximately 87 million warrants with an exercise price of $0.15 per
share. These warrants include 15,802,941 warrants owned by Optimus as part
of the Series B purchase agreement.
New
Accounting Pronouncements
In April
2010, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2010-17, Revenue Recognition—Milestone Method
(Topic 605) - Milestone Method of Revenue Recognition - a consensus of the FASB
Emerging Issues Task Force . This ASU provides guidance to vendors on the
criteria that should be met for determining whether the milestone method of
revenue recognition is appropriate. This guidance is effective prospectively for
revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Early adoption is permitted.
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.
Item
7A. Quantitative Qualitative Disclosures About Market Risk.
Not
Required
Item
8: Financial Statements and Supplementary Data.
The index
to Financial Statements appears on page F-1, the Report of the Independent
Registered Public Accounting Firm appears on page F-2, and the Financial
Statements and Notes to Financial Statements appear on pages F-3 to
F-22.
Item
9: Changes in and Disagreements with Accountants on Accounting and Financial
Disclosures.
None
35
Item
9A: Controls and Procedures.
As of the
end of the period covered by this report, we conducted an evaluation, under the
supervision and with the participation of our chief executive officer and chief
financial officer of our disclosure controls and procedures (as defined in Rule
13a-15(e) and Rule 15d-15(e) of the Exchange Act). Based upon this evaluation,
our chief executive officer and chief financial officer concluded that our
disclosure controls and procedures were effective to ensure that information
required to be disclosed by us in the reports that we file or submit under the
Exchange Act is: (1) accumulated and communicated to our management, including
our chief executive officer and chief financial officer, as appropriate to allow
timely decisions regarding required disclosure; and (2) recorded, processed,
summarized and reported, within the time periods specified in the SEC's rules
and forms.
Changes
in Internal Control Over Financial Reporting
During
the quarter ended October 31, 2010, the Company engaged the services of
additional professional accounting personnel and added procedures for the
purpose of improving internal controls over financial reporting.
Assessment
of the Effectiveness of Internal Controls over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Rules 13a-15(f)
under the Exchange Act. Our management assessed the effectiveness of
our internal control over financial reporting as of October 31, 2010 on criteria
for effective internal control over financial reporting described in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission. Based on this evaluation, management has
determined that as of October 31, 2010, there were no material weaknesses in our
internal control over financial reporting and that our internal control over
financial reporting was effective.
Attestation
Report of our Registered Public Accounting Firm
This
annual report does include an attestation report of our independent registered
public accounting firm regarding internal control over financial reporting. Our
management's report was not subject to attestation by our independent registered
public accounting firm pursuant to rules of the SEC that permit us to provide
only management's report in this annual report.
Item
9B: Other Information.
None
PART
III
Item
10: Directors, Executive Officers, Corporate Governance.
The
information required under this item will be set forth in the Company’s proxy
statement to be filed with the Securities and Exchange Commission on or before
February 28, 2011 and is incorporated herein by
reference.
Item
11: Executive Compensation.
The
information required under this item will be set forth in the Company’s proxy
statement to be filed with the Securities and Exchange Commission on or before
February 28, 2011 and is incorporated herein by
reference.
Item
12: Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters.
The
information required under this item will be set forth in the Company’s proxy
statement to be filed with the Securities and Exchange Commission on or before
February 28, 2011 and is incorporated herein by
reference.
Item
13: Certain Relationships and Related Transactions, and Director
Independence.
The
information required under this item will be set forth in the Company’s proxy
statement to be filed with the Securities and Exchange Commission on or before
February 28, 2011 and is incorporated herein by
reference.
Item
14: Principal Accountant Fees and Services.
The
information required under this item will be set forth in the Company’s proxy
statement to be filed with the Securities and Exchange Commission on or before
February 28, 2011 and is incorporated herein by reference.
36
PART
IV
Item
15: Exhibits, Financial Statements Schedules.
See Index
of Exhibits below. The Exhibits are filed with or incorporated by reference in
this report.
** Filed
herewith
(a) Exhibits.
The following
exhibits are included herein or incorporated herein by reference.
Exhibit
Number
|
Description
of Exhibit
|
|
2.1
|
Agreement
Plan and Merger of Advaxis, Inc. (a Colorado corporation) and Advaxis,
Inc. (a Delaware corporation). Incorporated by reference to
Annex B to DEF 14A Proxy Statement filed with the SEC on May 15,
2006.
|
|
3.1(i)
|
Amended
and Restated Certificate of Incorporation. Incorporated by
reference to Annex C to DEF 14A Proxy Statement filed with the SEC on May
15, 2006.
|
|
3.1(ii)
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 10.4
to Quarterly Report on Form 10-QSB filed with the SEC on September 13,
2006.
|
|
4.1
|
Form
of common stock certificate. Incorporated by reference to
Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on October
23, 2007.
|
|
4.2
|
Certificate
of Designations of Preferences, Rights and Limitations of Series A
Preferred Stock of the registrant, dated September 24, 2009. Incorporated
by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the
SEC on September 25, 2009.
|
|
4.3
|
Certificate
of Designations of Preferences, Rights and Limitations of Series B
Preferred Stock of the registrant, dated July 19, 2010. Incorporated by
reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC
on July 20, 2010.
|
|
4.4
|
Form
of warrant issued in the August 2007 financing. Incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC
on August 27, 2007.
|
|
4.5
|
Form
of warrant to purchase shares of the registrant’s common stock at the
price of $0.20 per share (the “$0.20 warrant”). Incorporated by
reference to Exhibit 4.2 to Current Report on Form 8-K filed with the SEC
on October 23, 2007.
|
|
4.6
|
Form
of warrant to purchase shares of the registrant’s common stock at the
price of $0.001 per share (the “$0.001 warrant”). Incorporated
by reference to Exhibit 4.3 to Current Report on Form 8-K filed with the
SEC on October 23, 2007.
|
|
4.7
|
Form
of Common Stock Purchase Warrant. Incorporated by reference to Exhibit 4.1
to Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
4.8
|
Form
of Warrant issued to Optimus CG II Ltd. pursuant to the Series A Preferred
Stock Purchase Agreement. Incorporated by reference to Exhibit
A to the Purchase Agreement included as Exhibit 10.1 to Current Report on
Form 8-K filed with the SEC on September 25, 2009.
|
|
4.9
|
Form
of Common Stock Purchase Warrant, issued in the junior bridge
financing. Incorporated by reference to Exhibit 4.12 to
Registration Statement on Form S-1 (File No. 333-162632) filed with the
SEC on October 22, 2009.
|
|
Form
of Amended and Restated Common Stock Purchase
Warrant. Incorporated by reference to Exhibit 4.2 to Current
Report on Form 8-K/A filed with the SEC on February 11,
2010.
|
||
4.11
|
Form
of Common Stock Purchase Warrant. Incorporated by reference to
Exhibit 4.3 to Current Report on Form 8-K/A filed with the SEC on February
11, 2010.
|
|
4.12
|
Form
of Additional Common Stock Purchase Warrant issued to Optimus CG II
Ltd. Incorporated by reference to Exhibit 4.1 to Current Report
on Form 8-K filed with the SEC on May 14, 2010.
|
|
4.13
|
Form
of Warrant issued to Optimus CG II Ltd. pursuant to the Series B Preferred
Stock Purchase Agreement. Incorporated by reference to Exhibit
A to the Purchase Agreement included as Exhibit 10.1 to Current Report on
Form 8-K filed with the SEC on July 20,
2010.
|
37
4.14
|
Form
of Common Stock Purchase Warrant. Incorporated by reference to
Exhibit 4.2 to Current Report on Form 8-K filed with the SEC on November
12, 2010.
|
|
10.1
|
Securities
Purchase Agreement between the registrant and the purchasers in the
private placement (the “SPA”), dated as of October 17, 2007, and
Disclosure Schedules thereto. Incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on October
23, 2007.
|
|
10.2
|
Securities
Purchase Agreement dated February 2, 2006 between the registrant and
Cornell Capital Partners, LP. Incorporated by reference to
Exhibit 10.01 to Report on Form 8-K filed with the SEC on February 8,
2006.
|
|
10.3
|
Registration
Rights Agreement between the registrant and the parties to the SPA, dated
as of October 17, 2007. Incorporated by reference to Exhibit
10.2 to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.4
|
Placement
Agency Agreement between the registrant and Carter Securities, LLC, dated
as of October 17, 2007. Incorporated by reference to Exhibit
10.3 to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.5
|
Engagement
Letter between the registrant and Carter Securities, LLC, dated August 15,
2007. Incorporated by reference to Exhibit 10.3(a) to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.6
|
Agreement
between the registrant and YA Global Investments, L.P. f/k/a Cornell
Capital Partners, L.P., dated August 23, 2007. Incorporated by
reference to Exhibit 10.4 to Current Report on Form 8-K filed with the SEC
on October 23, 2007.
|
|
10.7
|
Memorandum
of Agreement between the registrant and CAMHZN Master LDC and CAMOFI
Master LDC, purchasers of the Units consisting of common stock, $0.20
warrants, and $0.001 warrants, dated October 17,
2007. Incorporated by reference to Exhibit 10.5 to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.8
|
Advisory
Agreement between the registrant and Centrecourt Asset Management LLC,
dated August 1, 2007. Incorporated by reference to Exhibit 10.6
to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.9
|
Share
Exchange and Reorganization Agreement, dated as of August 25, 2004, by and
among the registrant, Advaxis and the shareholders of
Advaxis. Incorporated by reference to Exhibit 10.1 to Current
Report on Form 8-K filed with the SEC on November 18,
2004.
|
|
10.10
|
Security
Agreement dated February 2, 2006 between the registrant and Cornell
Capital Partners, L.P. Incorporated by reference to Exhibit
10.06 to Current Report on Form 8-K filed with the SEC on February 8,
2006.
|
|
10.11
|
Investor
Registration Rights Agreement dated February 2, 2006 between the
registrant and Cornell Capital Partners, LP. Incorporated by
reference to Exhibit 10.05 to Current Report on Form 8-K filed with the
SEC on February 8, 2006.
|
|
10.12
|
2004
Stock Option Plan of the registrant. Incorporated by reference
to Exhibit 4.1 to Report on Form S-8 filed with the SEC on December 1,
2005.
|
38
10.13
|
2005
Stock Option Plan of the registrant. Incorporated by reference
to Annex A to DEF 14A Proxy Statement filed with the SEC on May 15,
2006.
|
|
10.14
|
License
Agreement, between University of Pennsylvania and the registrant dated as
of June 17, 2002, as Amended and Restated on February 13,
2007. Incorporated by reference to Exhibit 10.11 to Annual
Report on Form 10-KSB filed with the SEC on February 13,
2007.
|
|
10.15
|
Sponsored
Research Agreement dated November 1, 2006 by and between University of
Pennsylvania (Dr. Paterson Principal Investigator) and the
registrant. Incorporated by reference to Exhibit 10.44 to
Annual Report on 10-KSB filed with the SEC on February 13,
2007.
|
|
10.16
|
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 Pre-Effective Amendment No. 2 filed on April
28, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.17
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the registrant. Incorporated by reference to Exhibit
10.9 to Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.18
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 10.27 to Annual Report on Form 10-KSB filed with the SEC on
January 25, 2006.
|
|
10.19
|
Second
Amendment dated October 31, 2005 to Consultancy Agreement between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 10.2 to Current Report on Form 8-K filed with the SEC on November
9, 2005.
|
|
10.20
|
Third
Amendment dated December 15, 2006 to Consultancy Agreement between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 9.01 to Current Report on Form 8-K filed with the SEC on December
15, 2006.
|
|
10.21
|
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 Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.22
|
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
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.23
|
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 Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.24
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and Advaxis,
Inc. Incorporated by reference to Exhibit 10.16 to Pre-Effective
Amendment No. 4 filed on June 9, 2005 to Registration Statement on Form
SB-2 (File No. 333-122504).
|
|
10.25
|
Securities
Purchase Agreement, dated as of January 12, 2005, by and between the
registrant and Harvest Advaxis LLC. Incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on January
18, 2005.
|
|
10.26
|
Registration
Rights Agreement, dated as of January 12, 2005, by and between the
registrant and Harvest Advaxis LLC. Incorporated by reference to
Exhibit 10.2 to Current Report on Form 8-K filed with the SEC on January
18, 2005.
|
|
10.27
|
Letter
Agreement, dated as of January 12, 2005 by and between the registrant and
Robert T. Harvey. Incorporated by reference to Exhibit 10.3 to
Current Report on Form 8-K filed with the SEC on January 18,
2005.
|
|
10.28
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David Filer
and the registrant. Incorporated by reference to Exhibit 10.20 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.29
|
Consulting
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the registrant. Incorporated by reference to
Exhibit 10.21 to Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
39
10.30
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman and the
registrant. Incorporated by reference to Exhibit 10.23 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.31
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and the
registrant. Incorporated by reference to Exhibit 10.24 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.32
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
registrant. Incorporated by reference to Exhibit 10.25 to
Pre-Effective Amendment No. 2 filed on April 8, 2005 to Registration
Statement on Form SB-2/A (File No. 333-122504).
|
|
10.33
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the registrant. Incorporated by
reference to Exhibit 10.26 to Pre-Effective Amendment No. 4 filed on June
9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.34
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the registrant. Incorporated by
reference to Exhibit 10.28 to Pre-Effective Amendment No. 4 filed on June
9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.35
|
Letter
Agreement between the registrant 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).
|
|
10.36
|
Consultancy
Agreement between the registrant 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).
|
|
10.37
|
Employment
Agreement dated August 21, 2007 between the registrant and Thomas
Moore. Incorporated by reference to Exhibit 10.3 to Current
Report on Form 8-K filed with the SEC on August 27,
2007.
|
|
10.38
|
Employment
Agreement dated February 9, 2006 between the registrant and Fred
Cobb. Incorporated by reference to Exhibit 10.35 to the
Registration Statement on Form SB-2 (File No. 333-132298) filed with the
SEC on March 9, 2006.
|
|
10.39
|
Termination
of Employment Agreement between J. Todd Derbin and the registrant dated
October 31, 2005. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on November 9,
2005.
|
|
10.40
|
Consulting
Agreement dated June 1, 2006 between the registrant and Biologics
Consulting Group Inc. Incorporated by reference to Exhibit
10.40 to Annual Report on Form 10-KSB field with the SEC on February 13,
2007.
|
|
10.41
|
Consulting
Agreement dated June 1, 2006 between the registrant and Biologics
Consulting Group Inc., as amended on June 1, 2007. Incorporated
by reference to Exhibit 10.42(i) to Annual Report on Form 10-KSB filed
with the SEC on January 16, 2008.
|
|
10.42
|
Master
Contract Service Agreement between the registrant and MediVector, Inc.
dated May 20, 2007. Incorporated by reference to Exhibit 10.44 to Annual
Report on Form 10-KSB filed with the SEC on January 16,
2008.
|
|
10.43
|
Form
of note issued in the August 2007 financing. Incorporated by
reference to Exhibit 10.2 to Current Report on Form 8-K filed with the SEC
on August 27, 2007.
|
|
10.44
|
Letter
of Agreement, dated November 21, 2007, between Crystal Research
Associates, LLC and the registrant. Incorporated by reference to Exhibit
10.45 to Annual Report on Form 10-KSB filed with the SEC on January 16,
2008.
|
|
10.45
|
Service
Proposal O781, dated May 14, 2007, to the Strategic Collaboration and
Long Term Vaccine Supply Agreement, dated October 31, 2005, between the
registrant and Cobra Biomanufacturing Plc. Incorporated by reference to
Exhibit 10.46 to Annual Report on Form 10-KSB filed with the SEC on
January 16, 2008.
|
|
10.46
|
Service
Proposal, dated September 20, 2007, to the Strategic Collaboration
and Long Term Vaccine Supply Agreement, dated October 31, 2005, between
the registrant and Cobra Biomanufacturing Plc. Incorporated by reference
to Exhibit 10.47 to Annual Report on Form 10-KSB filed with the SEC on
January 16, 2008.
|
|
10.47
|
Consulting
Agreement, dated May 1, 2007 between the registrant and Bridge Ventures,
Inc. Incorporated by reference to Exhibit 10.48 to Annual Report on Form
10-KSB filed with the SEC on January 16,
2008.
|
40
10.48
|
Consulting
Agreement, dated August 1, 2007 between the registrant and Dr. David
Filer. Incorporated by reference to Exhibit 10.49 to Annual Report on Form
10-KSB filed with the SEC on January 16, 2008.
|
|
10.49
|
Employment
Agreement dated February 29, 2008 between the registrant and Christine
Chansky. Incorporated by reference to Exhibit 10.50 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.50
|
Note
Purchase Agreement, dated September 22, 2008 by and between Thomas A.
Moore and the registrant. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on September 30,
2008.
|
|
10.51
|
Lease
Extension Agreement dated June 1, 2008 by and between New Jersey Economic
Development Authority and the registrant. Incorporated by reference to
Exhibit 10.55 to Annual Report on Form 10-KSB filed with the SEC on
January 29, 2009.
|
|
10.52
|
Technical/Quality
Agreement dated May 6, 2008 by and between Vibalogics GmbH and the
registrant. Incorporated by reference to Exhibit 10.57 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.53
|
Master
Service Agreement dated April 7, 2008 by and between Vibalogics GmbH and
the registrant. Incorporated by reference to Exhibit 10.58 to Annual
Report on Form 10-KSB filed with the SEC on January 29,
2009.
|
|
10.54
|
Agreement,
dated as of December 8, 2008, by and between The Sage Group and the
registrant. Incorporated by reference to Exhibit 10.59 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.55
|
Service
Agreement dated January 1, 2009 by and between AlphaStaff, Inc. and the
registrant. Incorporated by reference to Exhibit 10.60 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.56
|
Promissory
Note issued to Biotechnology Greenhouse Corporation of Southeastern
Pennsylvania, dated November 10, 2003. Incorporated by
reference to Exhibit 10.53 to Annual Report on Form 10-KSB filed with the
SEC on January 29, 2009.
|
|
10.57
|
Promissory
Note issued to Biotechnology Greenhouse Corporation of Southeastern
Pennsylvania, dated December 17, 2003. Incorporated
by reference to Exhibit 10.54 to Annual Report on Form 10-KSB filed with
the SEC on January 29, 2009.
|
|
10.58
|
Letter
of Intent dated November 20, 2008 by and between Numoda Corporation and
the registrant. Incorporated by reference to Exhibit 10.61 to Annual
Report on Form 10-KSB filed with the SEC on January 29,
2009.
|
|
10.59
|
Consulting
Agreement dated December 1, 2008 by and between Conrad Mir and the
registrant. Incorporated by reference to Exhibit 10.62 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.60
|
Form
of Note Purchase Agreement. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.61
|
Form
of Senior Secured Convertible Note. Incorporated by reference to Exhibit
4.2 to Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.62
|
Form
of Senior Promissory Note as amended, between the registrant and Thomas
Moore. Incorporated by reference to Exhibit 4.3 to Current Report on Form
8-K filed with the SEC on June 19, 2009.
|
|
10.63
|
Form
of Security Agreement. Incorporated by reference to Exhibit 10.2 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.64
|
Form
of Subordination Agreement. Incorporated by reference to Exhibit 10.3 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.65
|
Series
A Preferred Stock Purchase Agreement dated September 24, 2009 by and
between Optimus Capital Partners, LLC and the registrant. Incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC
on September 25, 2009.
|
|
10.66
|
Form
of Note Purchase Agreement, entered into in connection with the junior
bridge financing. Incorporated by reference to Exhibit 10.61 to
Registration Statement on Form S-1 (File No. 333-162632) filed with the
SEC on October 22, 2009.
|
|
10.67
|
Form
of Convertible Promissory Note, issued in the junior bridge
financing. Incorporated by reference to Exhibit 4.13 to
Registration Statement on Form S-1 (File No. 333-162632) filed with the
SEC on October 22, 2009.
|
|
10.68
|
Form
of Amended and Restated Senior Promissory Note, between the registrant and
Thomas Moore. Incorporated by reference to Exhibit 4.17 to
Annual Report on Form 10-K filed with the SEC on February 19,
2010.
|
|
10.69
|
Amendment
to Senior Promissory Note. Incorporated by reference to Exhibit
4.1 to Current Report on Form 8-K/A filed with the SEC on February 11,
2010.
|
|
10.70
|
Amended
and Restated 2009 Stock Option Plan of the
registrant. Incorporated by reference to Annex A to DEF 14A
Proxy Statement filed with the SEC on April 30, 2010.
|
|
10.71
|
Form
of Stock Purchase Agreement dated May 10, 2010 between the registrant and
Numoda Capital Innovations, LLC. Incorporated by reference to
Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on May 14,
2010.
|
|
10.72
|
Second
Amendment to the Amended and Restated Patent License Agreement between the
registrant and the University of Pennsylvania dated as of May 10,
2010. Incorporated by reference to Exhibit 10.1 to Quarterly
Report on Form 10-Q filed with the SEC on June 3, 2010.
|
|
10.73
|
Series
B Preferred Stock Purchase Agreement dated July 19, 2010 by and between
Optimus Capital Partners, LLC and the registrant. Incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC
on July 20, 2010.
|
|
10.74
|
Form
of Amended and Restated Promissory Note between Optimus CG II Ltd. and the
registrant. Incorporated by reference to Exhibit G to the Purchase
Agreement included as Exhibit 10.1 to Current Report on Form 8-K filed
with the SEC on July 20, 2010.
|
|
10.75
|
Form
of Security Agreement between Optimus CG II Ltd. and the registrant.
Incorporated by reference to Exhibit H to the Purchase Agreement included
as Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on July
20, 2010.
|
|
10.76
|
Separation
Agreement and General Release dated January 6, 2010 between the Company
and Fred Cobb. Incorporated by reference to Exhibit 10.1 to
Quarterly Report on Form 10-Q filed with the SEC on September 14,
2010.
|
|
10.77
|
Form
of Note Purchase Agreement. Incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on November
12, 2010.
|
|
10.78
|
Form
of Convertible Promissory Note. Incorporated by reference to
Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on November
12, 2010.
|
|
14.1
|
Code
of Business Conduct and Ethics dated November 12,
2004. Incorporated by reference to Exhibit 14.1 to Current
Report on Form 8-K filed with the SEC on November 18,
2004.
|
41
23.1**
|
Consent
of McGladrey & Pullen, LLP.
|
|
24.1
|
|
Power
of Attorney (Included in the signature page of this annual
report).
|
31.1**
|
Certification
of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002
|
|
31.2**
|
Certification
of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002
|
|
32.1**
|
Certification
of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley
Act of 2002
|
|
32.2**
|
Certification
of Chief Financial Officer pursuant to section 906 of the
Sarbanes-Oxley Act of
2002
|
42
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this Annual Report to be signed on its behalf by the undersigned,
thereunto duly authorized, in North Brunswick, Middlesex County, State of New
Jersey, on this 31st day of January, 2011.
|
ADVAXIS,
INC.
|
|
By:
|
/s/ Thomas Moore
|
|
Thomas Moore, Chief Executive Officer and Chairman
of the Board
|
KNOW ALL
PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Thomas Moore and Mark J. Rosenblum (with full power to
act alone), as his true and lawful attorneys-in-fact and agents, with full
powers of substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign any and all amendments to this Annual
Report on Form 10-K and to file the same, with all exhibits thereto, and other
documents in connection therewith, with the Securities and Exchange Commission,
granting unto said attorneys-in-fact and agents full power and authority to do
and perform each and every act and thing requisite or necessary to be done in
and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or their substitute or substitutes, lawfully do or
cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this
report has been signed by the following persons on behalf of the registrant and
in the capacities and on the dates indicated:
SIGNATURE
|
TITLE
|
DATE
|
||
/s/
Thomas Moore
|
Chief
Executive Officer and Chairman of the Board
|
January
31, 2011
|
||
Thomas
Moore
|
(Principal
Executive Officer)
|
|||
/s/ Mark
J. Rosenblum
|
Chief
Financial Officer, Senior Vice President and Secretary
|
January
31, 2011
|
||
Mark
J. Rosenblum
|
(Principal
Financial and Accounting Officer)
|
|||
/s/ John
M. Rothman
|
Executive
Vice President of Science and Operations
|
January
31, 2011
|
||
John
M. Rothman
|
(Chief
Operating Officer)
|
|||
/s/
Roni Appel
|
Director
|
January
31, 2011
|
||
Roni
Appel
|
||||
/s/
Thomas McKearn
|
Director
|
January
31, 2011
|
||
Thomas
McKearn
|
||||
/s/
James Patton
|
Director
|
January
31, 2011
|
||
James
Patton
|
||||
/s/
Richard Berman
|
Director
|
January
31, 2011
|
||
Richard
Berman
|
43
ADVAXIS,
INC.
FINANCIAL
STATEMENTS
INDEX
Page
|
||
Advaxis,
Inc.
|
|
|
Reports
of Independent Registered Public Accounting Firm
|
F-1
|
|
Balance
Sheets as of October 31, 2010 and 2009
|
F-2
|
|
Statements
of Operations for the years ended October 31, 2010 and 2009 and the period
from
|
||
March
1, 2002 (Inception) to October 31, 2010
|
F-3
|
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to
|
||
October
31, 2010
|
F-4
|
|
Statements
of Cash Flows for the years ended October 31, 2010 and 2009 and the period
from
|
||
March
1, 2002 (Inception) to October 31, 2010
|
F-5
|
|
Notes
to the Financial Statements
|
F-7
|
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Shareholders
Advaxis,
Inc.
North Brunswick, New Jersey
We have
audited the accompanying balance sheets of Advaxis, Inc. as of October 31, 2010
and 2009, and the related statements of operations, stockholders' equity
(deficiency), and cash flows for the years then ended and for the cumulative
period from March 1, 2002 (inception) to October 31, 2010. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform an audit of its internal
control over financial reporting. Our audit included consideration of
internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion.
An audit also includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements, assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Advaxis, Inc. as of October 31,
2010 and 2009, and the results of its operations and its cash flows for the
years then ended and the cumulative period from March 1, 2002 (inception) to
October 31, 2010 in conformity with U.S. generally accepted accounting
principles.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company’s products are being developed and have not generated
significant revenues. As a result, the Company has suffered recurring losses and
its liabilities exceed its assets. This raises substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
/s/ MCGLADREY & PULLEN, LLP
MCGLADREY
& PULLEN, LLP
New York,
New York
January
31, 2011
F-1
ADVAXIS,
INC.
(A
Development Stage Company)
Balance
Sheet
October 31,
2010
|
October 31,
2009
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 108,381 | $ | 659,822 | ||||
Grant
Receivable
|
244,479 | - | ||||||
Prepaid
expenses
|
38,511 | 36,445 | ||||||
Total
Current Assets
|
391,371 | 696,267 | ||||||
Deferred
expenses
|
233,322 | 288,544 | ||||||
Property
and Equipment (net of accumulated depreciation)
|
28,406 | 54,499 | ||||||
Intangible
Assets (net of accumulated amortization)
|
2,125,991 | 1,371,638 | ||||||
Deferred
Financing Cost
|
- | 299,493 | ||||||
Other
Assets
|
96,096 | 3,876 | ||||||
TOTAL
ASSETS
|
$ | 2,875,186 | $ | 2,714,317 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 2,586,008 | $ | 2,368,716 | ||||
Accrued
expenses
|
647,125 | 917,250 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
751,456 | 2,078,851 | ||||||
Notes
payable – current portion, including interest payable
|
687,034 | 1,121,094 | ||||||
Total
Current Liabilities
|
4,671,623 | 6,485,911 | ||||||
Common
Stock Warrant
|
13,006,194 | 11,961,734 | ||||||
Total
Liabilities
|
17,677,817 | 18,447,645 | ||||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred
Stock; issued and outstanding 789 at October 31, 2010 and 0 at October 31,
2009. Series A Preferred Stock; issued and outstanding 0 at October 31,
2010 and 0 at October 31, 2009
|
- | |||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 198,100,817 in 2010 and 115,638,243 in
2009
|
198,101 | 115,638 | ||||||
Additional
Paid-In Capital
|
23,074,978 | 754,834 | ||||||
Stock
Subscription Receivable
|
(10,659,710 | ) | ||||||
Deficit
accumulated during the development stage
|
(27,416,000 | ) | (16,603,800 | ) | ||||
Total
Shareholders’ Deficiency
|
(14,802,631 | ) | (15,733,328 | ) | ||||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$ | 2,875,186 | $ | 2,714,317 |
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial
statements.
F-2
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Operations
Year Ended
October 31,
|
Year Ended
October 31,
|
Period from
March 1, 2002
(Inception) to
October 31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
Revenue
|
$
|
508,481
|
$
|
29,690
|
$
|
1,863,343
|
||||||
Research
& Development Expenses
|
4,
904,298
|
2,315,557
|
15,077,839
|
|||||||||
General
& Administrative Expenses
|
3,530,198
|
2,701,133
|
16,239,898
|
|||||||||
Total
Operating expenses
|
8,434,496
|
5,016,690
|
31,317,737
|
|||||||||
Loss
from Operations
|
(7,926,015
|
)
|
(4,987,000
|
)
|
(29,454,394
|
)
|
||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(3,814,863
|
)
|
(851,008
|
)
|
(5,750,354
|
)
|
||||||
Other
Income
|
80,161
|
326,618
|
||||||||||
Gain
on note retirement
|
123,963
|
-
|
1,656,440
|
|||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
445,576
|
5,845,229
|
4,648,573
|
|||||||||
Net
Income/( Loss) before income tax benefit
|
(11,091,178
|
)
|
7,221
|
(28,573,117
|
)
|
|||||||
Income
Tax Benefit
|
278,978
|
922,023
|
1,201,001
|
|||||||||
Net
Income/( Loss)
|
(10,812,200
|
)
|
(929,244
|
)
|
(27,372,116
|
)
|
||||||
Dividends
attributable to preferred shares
|
-
|
-
|
43,884
|
|||||||||
Net
Income/( Loss) applicable to Common Stock
|
$
|
(10,812,200
|
)
|
$
|
(929,244
|
)
|
$
|
(27,416,000
|
)
|
|||
Net
Income/(Loss) per share, basic
|
$
|
(0.07
|
)
|
$
|
0.01
|
|||||||
Net
Income/(Loss) per share, diluted
|
$
|
(0.07
|
)
|
$
|
0.01
|
|||||||
Weighted
average number of shares outstanding, basic
|
150,928,808
|
113,365,584
|
||||||||||
Weighted
average number of shares outstanding, diluted
|
150,928,808
|
118,264,246
|
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial statements.
F-3
ADVAXIS,
INC.
(a
development stage company)
STATEMENT
OF SHAREHOLDERS’ EQUITY (DEFICIENCY)
Period
from March 1, 2002 (inception) to October 31, 2010
Preferred Stock
|
Common Stock
|
Deficit
|
||||||||||||||||||||||||||||||
Number of
Shares of
Outstanding
|
Amount
|
Number of shares
of outstanding
|
Amount
|
Stock
Subscription
Receivable
|
Additional Paid-
in Capital
|
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 & professionals
|
10,493 | $ | 10,493 | |||||||||||||||||||||||||||||
Net
Loss
|
(166,936 | ) | $ | (166,936 | ) | |||||||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 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 Nov. 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 Nov. 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 Nov. 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 | ) | |||||||||||||||||||||||||
Common
Stock issued
|
59,228,334 | 59,228 | 9,321,674 | 9,380,902 | ||||||||||||||||||||||||||||
Offering
Expenses
|
(2,243,535 | ) | (2,243,535 | ) | ||||||||||||||||||||||||||||
Options
granted to consultants and professionals
|
268,577 | 268,577 | ||||||||||||||||||||||||||||||
Options
granted to employees and directors
|
222,501 | 222,501 | ||||||||||||||||||||||||||||||
Conversion
of debenture to Common Stock
|
6,974,202 | 6,974 | 993,026 | 1,000,010 | ||||||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
416,448 | 416 | 73,384 | 73,800 | ||||||||||||||||||||||||||||
Issuance
of common stock to consultants
|
1,100,001 | 1,100 | 220,678 | 221,778 | ||||||||||||||||||||||||||||
Warrants
issued on conjunction with issuance of common stock
|
1,505,550 | 1,505,550 | ||||||||||||||||||||||||||||||
Net
loss
|
(2,454,453 | ) | (2,454,453 | ) | ||||||||||||||||||||||||||||
Balance
at October 31, 2007
|
107,957,977 | $ | 107,957 | $ | 16,276,648 | $ | (12,116,626 | ) | $ | 4,267,979 | ||||||||||||||||||||||
Common
Stock Penalty Shares
|
211,853 | 212 | 31,566 | - | 31,778 | |||||||||||||||||||||||||||
Offering
Expenses
|
(78,013 | ) | (78,013 | ) | ||||||||||||||||||||||||||||
Options
granted to consultants and professionals
|
(42,306 | ) | (42,306 | ) | ||||||||||||||||||||||||||||
Options
granted to employees and directors
|
257,854 | 257,854 | ||||||||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
995,844 | 996 | 85,005 | 86,001 | ||||||||||||||||||||||||||||
Issuance
of common stock to consultants
|
153,846 | 154 | 14,462 | 14,616 | ||||||||||||||||||||||||||||
Warrants
issued to consultant
|
39,198 | 39,198 | ||||||||||||||||||||||||||||||
Net
loss
|
(5,416,418 | ) | (5,416,418 | ) | ||||||||||||||||||||||||||||
Balance
at October 31, 2008
|
109,319,520 | $ | 109,319 | $ | 16,584,414 | $ | (17,533,044 | ) | $ | (839,311 | ) | |||||||||||||||||||||
Common
stock issued upon exercise of warrants
|
3,299,999 | 3,300 | (3,300 | ) | 0 | |||||||||||||||||||||||||||
Warrants
classified as a liability
|
(12,785,695 | ) | (12,785,695 | ) | ||||||||||||||||||||||||||||
Issuance
of common Stock Warrants
|
(3,587,625 | ) | (3,587,625 | ) | ||||||||||||||||||||||||||||
Options
granted to professionals and consultants
|
12,596 | 12,596 | ||||||||||||||||||||||||||||||
Options
granted to employees and directors
|
0 | 467,304 | 467,304 | |||||||||||||||||||||||||||||
Issuance
of common stock to employees and directors
|
422,780 | 423 | 17,757 | 18,180 | ||||||||||||||||||||||||||||
Issuance
of common stock to consultants
|
2,595,944 | 2,596 | 49,383 | 51,979 | ||||||||||||||||||||||||||||
Net
Income/ (Loss)
|
929,244 | 929,244 | ||||||||||||||||||||||||||||||
Balance
at October 31, 2009
|
115,638,243 | $ | 115,638 | $ | 754,834 | $ | (16,603,800 | ) | $ | (15,733,328 | ) | |||||||||||||||||||||
Preferred
Stock issued
|
789 | - | 6,828,293 | 6,828,293 | ||||||||||||||||||||||||||||
Common
stock issued upon exercise of warrants
|
62,265,059 | 62,265 | (10,659,710 | ) | 18,647,522 | 8,050,077 | ||||||||||||||||||||||||||
Options
granted to employees and directors
|
455,166 | 455,166 | ||||||||||||||||||||||||||||||
Common
stock issued upon conversion of Bridge Notes
|
15,413,960 | 15,414 | 3,306,677 | 3,322,091 | ||||||||||||||||||||||||||||
Common
stock issued to Numoda
|
3,500,000 | 3,500 | 591,500 | 595,000 | ||||||||||||||||||||||||||||
Common
stock issued to University of Pennsylvania
|
388,889 | 389 | 69,611 | 70,000 | ||||||||||||||||||||||||||||
Common
stock issued to employees and directors
|
750,000 | 750 | 114,750 | 115,500 | ||||||||||||||||||||||||||||
Common
stock issued to former employees
|
144,666 | 145 | (145 | ) | - | |||||||||||||||||||||||||||
Issuance
of common stock warrants
|
(7,693,230 | ) | (7,865,520 | ) | ||||||||||||||||||||||||||||
Net
Income/ (Loss)
|
(10,812,200 | ) | (10,812,200 | ) | ||||||||||||||||||||||||||||
Balance
at October 31, 2010
|
789 | - | 198,100,817 | $ | 198,101 | $ | (10,659,710 | ) | $ | 23,074,978 | $ | (27,416,000 | ) | $ | (14,802,631 | ) |
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial statements.
F-4
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Cash Flows
|
Period from
|
|||||||||||
March 1
|
||||||||||||
2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
Income (Loss)
|
$
|
(10,812,200
|
)
|
$
|
929,244
|
$
|
(27,372,116
|
)
|
||||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and stock
|
570,664
|
571,525
|
3,005,419
|
|||||||||
Amortization
of deferred financing costs
|
-
|
-
|
260,000
|
|||||||||
Amortization
of deferred expenses
|
212,952
|
61,456
|
274,408
|
|||||||||
Amortization
of discount on Bridge Loans
|
550,040
|
123,846
|
673,886
|
|||||||||
Impairment
of intangible assets
|
-
|
-
|
26,087
|
|||||||||
Non-cash
interest expense
|
3,238,054
|
698,650
|
4,464,520
|
|||||||||
(Gain)
Loss on change in value of warrants and embedded
derivative
|
(445,576
|
)
|
(5,845,229
|
)
|
.(4,648,573
|
)
|
||||||
Warrant
Expense
|
206,275
|
-
|
206,275
|
|||||||||
Value
of penalty shares issued
|
-
|
-
|
149,276
|
|||||||||
Depreciation
expense
|
38,528
|
36,648
|
167,266
|
|||||||||
Amortization
expense of intangibles
|
100,420
|
74,508
|
462,352
|
|||||||||
Gain
on note retirement
|
(123,963
|
)
|
-
|
(1,656,440
|
)
|
|||||||
(Increase)
decrease in prepaid expenses
|
(2,066
|
)
|
2,417
|
(38,510
|
)
|
|||||||
(Increase)
decrease in grant receivable
|
(244,479
|
)
|
-
|
(244,479
|
)
|
|||||||
Decrease
(increase) in other assets
|
(89,956
|
)
|
-
|
(93,833
|
)
|
|||||||
Increase
in accounts payable
|
388,924
|
1,421,838
|
3,167,193
|
|||||||||
(Decrease)
increase in accrued expenses
|
167,143
|
(109,540
|
)
|
634,761
|
||||||||
(Decrease)
increase in interest payable
|
(178,700
|
)
|
-
|
(160,409
|
)
|
|||||||
Net
cash used in operating activities
|
(6,423,940
|
)
|
(2,034,636
|
)
|
(20,722,917
|
)
|
||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||||
Purchase
of property and equipment
|
(12,436
|
)
|
-
|
(150,093
|
)
|
|||||||
Cost
of intangible assets
|
(854,773
|
)
|
(308,749
|
)
|
(2,619,382
|
)
|
||||||
Net
cash used in Investing Activities
|
(867,209
|
)
|
(308,749
|
)
|
(2,814,415
|
)
|
||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
80,000
|
-
|
1,040,000
|
|||||||||
Cash
paid for deferred financing costs
|
-
|
(299,493
|
)
|
(559,493
|
)
|
|||||||
Proceeds
from notes payable
|
1,255,000
|
3,259,635
|
6,260,859
|
|||||||||
Payment
on notes payable
|
(1,798,119
|
)
|
(16,672
|
)
|
(1,921,710
|
)
|
||||||
Net
proceeds of issuance of Preferred Stock
|
7,032,827
|
-
|
7,267,827
|
|||||||||
Payment
on cancellation of Warrants
|
-
|
-
|
(600,000
|
)
|
||||||||
Proceeds
from the exercise of warrants
|
170,000
|
-
|
170,000
|
|||||||||
Net
proceeds of issuance of Common Stock
|
-
|
-
|
11,988,230
|
|||||||||
Net
cash provided by Financing Activities
|
6,739,708
|
2,943,469
|
23,645,713
|
|||||||||
Net
increase in cash
|
(551,441)
|
600,084
|
108,381
|
|||||||||
Cash
at beginning of period
|
659,822
|
59,738
|
-
|
|||||||||
Cash
at end of period
|
$
|
108,381
|
$
|
659,822
|
$
|
108,381
|
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial
statements.
F-5
Supplemental Schedule of
Noncash Investing and Financing Activities
Period from
|
||||||||||||
March 1, 2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2010
|
2009
|
2010
|
||||||||||
Equipment
acquired under notes payable
|
$
|
$
|
-
|
$
|
45,580
|
|||||||
Common
Stock issued to Founders
|
$
|
$
|
-
|
$
|
40
|
|||||||
Notes
payable and accrued interest converted to Preferred Stock
|
$
|
$
|
-
|
$
|
15,969
|
|||||||
Stock
dividend on Preferred Stock
|
$
|
$
|
-
|
$
|
43,884
|
|||||||
Accounts
payable from consultants settled with common stock
|
$
|
$
|
51,978
|
$
|
51,978
|
|||||||
Notes
payable and embedded derivative liabilities converted to Common
Stock
|
$
|
3,322,092
|
$
|
-
|
$
|
5,835,250
|
||||||
Intangible
assets acquired with notes payable
|
$
|
$
|
-
|
$
|
360,000
|
|||||||
Intangible
assets acquired with common stock
|
$
|
70,000
|
$
|
$
|
70,000
|
|||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$
|
578,770
|
$
|
1,579,646
|
$
|
2,661,212
|
||||||
Allocation
of the original secured convertible debentures to warrants
|
$
|
$
|
-
|
$
|
214,950
|
|||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$
|
712,036
|
$ |
940,511
|
$
|
1,652,547
|
||||||
Note
Receivable in connection with the exercise of warrants
|
$
|
10,659,710
|
$
|
$
|
10,659,710
|
|||||||
Warrants
issued in connection with issuance of Common Stock
|
$
|
$
|
-
|
$
|
1,505,550
|
|||||||
Warrants
issued in connection with issuance of Preferred Stock
|
$
|
$
|
3,587,625
|
$
|
3,587,625
|
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial statements.
F-6
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.
The
preparation of financial statements in accordance with GAAP involves the use of
estimates and assumptions that affect the recorded amounts of assets and
liabilities as of the date of the financial statements and the reported amounts
of revenue and expenses during the reporting period. Actual results may differ
substantially from these estimates. Significant estimates include the fair value
and recoverability of the carrying value of intangible assets (patents and
licenses) the fair value of options, the fair value of embedded conversion
features, warrants, and related disclosure of contingent assets and liabilities.
On an on-going basis, we evaluate our estimates, based on historical experience
and on various other assumptions that we believe to be reasonable under the
circumstances. Actual results may differ from these estimates.
The
Company’s products are being developed and have not generated significant
revenues. As a result, the Company has suffered recurring losses and its
liabilities exceed its assets which raises substantial doubt about our ability
to continue as a going concern. These losses are expected to continue for an
extended period of time. The Company intends to continue raising funds through
the sale of both debt and equity in order to continue funding ongoing clinical
trials activity. The financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. There is a working capital deficiency
and recurring losses that raise substantial doubt about its ability to continue
as a going concern. The financial statement does not include any
adjustments to the carrying amount and classification of recorded assets and
liabilities should we be unable to continue operations.
F-7
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 collectability 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 straight line method or
another method if it better represents the timing and pattern of performance.
Since its inception and through October 31, 2010 all of the Company’s revenues
have been from grants. For the years ended October 31, 2010 and 2009, all of the
Company’s revenues were received from multiple grants.
For
revenue contracts that contain multiple elements, 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 (money market) that at times
exceed federally insured limits.
Equipment
is stated at cost. Depreciation and amortization are provided for on a
straight-line basis over the estimated useful life of the asset ranging from 3
to 5 years. Expenditures for maintenance and repairs that do not materially
extend the useful lives of the respective assets are charged to expense as
incurred. The cost and accumulated depreciation and/or amortization of assets
retired or sold are removed from the respective accounts and any gain or loss is
recognized in operations.
Intangible
assets, which consist primarily of legal and filing costs in obtaining patents
and licenses and are being amortized on a straight-line basis over 20
years.
We review
our long-lived assets for impairment whenever events and circumstances indicate
that the carrying value of an asset might not be recoverable and its carrying
amount exceeds its fair value, which is based upon estimated undiscounted future
cash flows. Net assets recorded on the balance sheet for patents and licenses
related to ADXS11-001, ADXS31-142, ADXS31-164 and other products are in
development. However, if a competitor were to gain FDA approval for a treatment
before us or if future clinical trials fail to meet the targeted endpoints, we
would likely record an impairment related to these assets. In addition, if an
application is rejected or fails to be issued we would record an impairment of
its estimated book value.
Net
Loss Per Share
Basic net
income or basic net loss per common share is computed by dividing net income
available to common shareholders by the weighted average number of common shares
outstanding during the periods. Diluted earnings per share give effect to
dilutive options, warrants, convertible debt and other potential common
stock outstanding during the period. Therefore, in the case of a net loss the
impact of the potential common stock resulting from warrants, outstanding stock
options and convertible debt are not included in the computation of diluted
loss per share, as the effect would be anti-dilutive. In the case of net income
the impact of the potential common stock resulting from these instruments that
have intrinsic value are included in the diluted earnings per share. The table
sets forth the number of potential shares of common stock that have been
excluded from diluted net loss per share. The warrants (excluding approximately
15.8 million warrants held by an affiliate of Optimus (as defined below) include
anti-dilutive provisions to adjust the number and price of the warrants based on
certain types of equity transactions.
As of October 31,
|
||||||||
2010
|
2009
|
|||||||
Warrants
|
103,139,628
|
127,456,301
|
||||||
Stock
Options
|
26,467,424
|
7,881,591
|
||||||
Convertible
Debt (using the if-converted method)
|
4,358,176
|
49,749,280
|
||||||
Total
|
133,965,228
|
185,087,172
|
Income
Taxes
Deferred
income taxes are provided for the differences between the bases of assets and
liabilities for financial reporting and income tax purposes. Future ownership
changes may limit the future utilization of these net operating loss and
research and development tax credit carry-forwards as defined by the Internal
Revenue Code. The amount of any potential limitation is unknown. The net
deferred tax asset has been fully offset by a valuation allowance due to our
history of taxable losses and uncertainty regarding our ability to generate
sufficient taxable income in the future to utilize these deferred tax
assets.
F-8
Accounts
payable consists entirely of trade accounts payable
Research
and Development Expenses
Research
and development expenses include, but are not limited to, payroll and personnel
expenses, lab expenses, clinical trial and related clinical manufacturing costs,
facilities and related overhead costs.
Accounting
for Stock-Based Compensation
Stock-based
compensation is estimated at the grant date based on the award’s fair value as
calculated by the Black-Scholes-Merton option-pricing model (hereinafter
referred to as the “BSM model”) and is recognized as expense over the requisite
service period. The BSM model requires various assumptions including volatility,
forfeiture rates and expected option life. If any of the assumptions used in the
BSM model change significantly, stock-based compensation expense may differ
materially in the future from that recorded in the current period. See Note 5
for information on stock-based compensation expense incurred in the years ending
October 31, 2010 and 2009.
Warrant
Liability/Embedded Derivative Liability
The
Company has outstanding Warrants and convertible features (Embedded Derivatives)
in its outstanding Senior and Junior Subordinated Promissory Notes. We
refer to all Senior Convertible Promissory Notes and Junior Subordinated
Convertible Promissory Notes as “Bridge Notes”. The Warrants and Embedded
Derivatives are recorded at their relative fair values at issuance and will
continue to be recorded at fair value each subsequent balance sheet date. Any
change in value between reporting periods will be recorded at each reporting
date. Both derivatives will continue to be reported until such time as they are
exercised, expire, or mature at which time these derivatives will be adjusted to
fair value and reclassified from liabilities to equity.
In
April 2010, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2010-17, Revenue Recognition—Milestone Method
(Topic 605) - Milestone Method of Revenue Recognition - a consensus of the FASB
Emerging Issues Task Force . This ASU provides guidance to vendors on the
criteria that should be met for determining whether the milestone method of
revenue recognition is appropriate. This guidance is effective prospectively for
revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Early adoption is permitted. The
Company has not yet begun to generate revenues that contain milestone payments,
as it is still a pre-revenue, development stage company. ASU 2010-17 will
be reviewed and implemented, if applicable to the company’s revenue
arrangements, in the fiscal year in which the company begins to generate
revenues.
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.
2.
SHARE-BASED COMPENSATION EXPENSE
The
Company adopted ASC 718 and uses the modified prospective transition
method, which requires the application of the accounting standard as of November
1, 2005, the first day of the Company’s fiscal year 2006. In accordance with the
modified prospective transition method, the Company’s Financial Statements for
prior periods were not restated to reflect, and do not include the impact of ASC
718. The Company began recognizing expense in an amount equal to the fair
value of share-based payments (stock option awards) on their date of grant, over
the requisite service period of the awards (usually the vesting period). Under
the modified prospective method, compensation expense for the Company is
recognized for all share based payments granted and vested on or after
November 1, 2005 and all awards granted to employees prior to November 1,
2005 that were unvested on that date but vested in the period over the requisite
service periods in the Company’s Statement of Operations. Prior to the adoption
of the fair value method, the Company accounted for stock-based compensation to
employees under the intrinsic value method of accounting set forth in Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to
Employees , and related interpretations. Therefore, compensation expense
related to employee stock options was not reflected in operating expenses in any
period prior to the fiscal year of 2006 and prior period results have not been
restated. Since the date of inception to October 31, 2005 had the Company
adopted the fair value based method of accounting for stock-based employee
compensation under the provisions of ASC 718, Stock Compensation expense would
have totaled $328,176 and the effect on the Company’s net loss would have been
as follows for the period March 1, 2002 (date of inception) to October 31,
2010:
F-9
March 1, 2002
(date of
inception) to
October 31,
2010
|
||||
Net
Loss as reported
|
$
|
(27,372,116
|
)
|
|
Add:
Stock based option expense included in recorded net loss
|
89,217
|
|||
Deduct
stock option compensation expense determined under fair value based
method
|
(328,176
|
)
|
||
Adjusted
Net Loss
|
$
|
(27,611,075
|
)
|
The fair
value of each option granted from the Company’s stock option plans during the
years ended October 31, 2010 and 2009 was estimated on the date of grant using
the Black-Scholes option-pricing model. Using this model, fair value is
calculated based on assumptions with respect to (i) expected volatility of
the Company’s Common Stock price, (ii) the periods of time over which employees
and Board Directors are expected to hold their options prior to exercise
(expected lives), (iii) expected dividend yield on the Company’s Common
Stock, and (iv) risk-free interest rates, which are based on quoted U.S.
Treasury rates for securities with maturities approximating the options’
expected lives. The company used their own historical volatility in
determining the volatility to be used. Expected lives are based on contractual
terms given the early stage of the business and lack of intrinsic value. The
expected dividend yield is zero as the Company has never paid dividends to
common shareholders and does not currently anticipate paying any in the
foreseeable future.
Year Ended
|
Year Ended
|
|||||||
October 31,
2010
|
October 31,
2009
|
|||||||
Expected
volatility
|
156.5% | 170.2% | ||||||
Expected
Life
|
10.0
years
|
6.0
years
|
||||||
Dividend
yield
|
0 | 0 | ||||||
Risk-free
interest rate
|
2.75% | 3.5% |
Stock-based
compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that vested during the period. Stock-based
compensation expense for the twelve months ended October 31, 2010 includes
compensation expense for share-based payment awards granted prior to, but not
yet vested as of October 31, 2005 based on the grant date fair value and
compensation expense for the share-based payment awards granted subsequent to
October 31, 2005 based on the grant date fair value estimated in accordance with
the provisions of ASC 718. Compensation expense for all share-based payment
awards to be recognized using the straight line method over the requisite
service period. As stock-based compensation expense for the fiscal years 2010
and 2009 is based on awards granted and vested, it has been reduced for
estimated forfeitures (4.4%). ASC 718 requires forfeitures to be estimated at
the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. In the Company’s pro forma information
required under SFAS 123 for the periods prior to fiscal 2006, the Company
accounted for forfeitures as they occurred.
The
Company accounts for nonemployee stock-based awards in which goods or services
are the consideration received for the equity instruments issued based on the
fair value of the equity instruments.
3.
INTANGIBLE ASSETS
Intangible
assets primarily consist of legal and filing costs associated with obtaining
patents and licenses. The license and patent costs capitalized primarily
represent the value assigned to the Company’s 20-year exclusive worldwide
license agreement with Penn which are amortized on a straight-line basis over
their remaining useful lives which are estimated to be twenty years from the
effective date of Penn Agreement dated July 1, 2002. The value of the license
and patents are based on management’s assessment regarding the ultimate
recoverability of the amounts paid and the potential for alternative future
uses. This license now includes the exclusive right to exploit 32 patents issued
and 33 patents pending and applied for in most of the largest markets in the
world.
As of
October 31, 2010, all gross capitalized costs associated with the licenses and
patents filed and granted as well as costs associated with patents pending are
$2,506,347 as shown under license and patents on the table below. The
expirations of the existing patents range from 2014 to 2023 but the expirations
can be extended based on market approval if granted and/or based on existing
laws and regulations. Capitalized costs associated with patent applications that
are abandoned without future value are charged to expense when the determination
is made not to pursue the application. No other patent applications with future
value were abandoned and charged to expense in the current or prior year.
Amortization expense for licensed technology and capitalized patent cost is
included in general and administrative expenses.
Under the
amended and restated agreement we are billed actual patent expenses as they are
passed through from Penn and or billed directly from our patent attorney. The
following is a summary of intangible assets as of the end of the following
fiscal periods:
F-10
October
31,
2010
|
October
31,
2009
|
|||||||
License
|
$
|
651,992
|
$
|
571,275
|
||||
Patents
|
1,854,355
|
1,080,299
|
||||||
Total
intangibles
|
2,506,347
|
1,651,574
|
||||||
Accumulated
Amortization
|
(380,356
|
)
|
(279,936
|
)
|
||||
Intangible
Assets
|
$
|
2,125,991
|
$
|
1,371,638
|
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.
4. ACCRUED
EXPENSES:
The
following table represents the major components of accrued
expenses:
October 31,
2010
|
October 31,
2009
|
|||||||
Salaries
and other compensation
|
$ | 500,927 | $ | 768,552 | ||||
Sponsored
Research Agreement
|
119,698 | 119,698 | ||||||
Consultants
|
18,000 | 29,000 | ||||||
Other
|
8,500 | - | ||||||
$ | 647,125 | $ | 917,250 |
5. NOTES
PAYABLE:
Moore
Notes
On
September 22, 2008, Advaxis entered into an agreement (the “Moore Agreement”)
with the Company’s Chief Executive Officer, Thomas Moore, pursuant to which the
Company agreed to sell senior promissory notes to Mr. Moore, from time to time
(“the Moore Notes”). On June 15, 2009, Mr. Moore and the Company amended the
Moore Notes to increase the amounts available pursuant to the Moore Agreement
from $800,000 to $950,000 and changed the maturity date of the Moore Notes from
June 15, 2009 to the earlier of (i) default under the terms of the Moore
Agreement or (ii) the Company’s next equity financing resulting in gross
proceeds to the Company of at least $6 million. The Moore Agreement was amended
per the terms of the June 18, 2009 Note Purchase Agreement (described below)
retroactively to include the same warrant provision provided to investors
purchasing notes under the Note Purchase Agreement.
On
February 15, 2010, we agreed to amend the terms of the Moore Notes such that (i)
Mr. Moore may elect, at his option, to receive accumulated interest thereon on
or after March 17, 2010, (ii) we would begin to make monthly installment
payments of $100,000 on the outstanding principal amount beginning on April 15,
2010; provided, however, that the balance of the principal will be repaid in
full on consummation of our next equity financing resulting in gross proceeds to
us of at least $6.0 million and (iii) we would retain $200,000 of the repayment
amount for investment in our next equity financing.
The
Company issued 1,176,471 shares in satisfaction of $200,000 of the aggregate
principal amount outstanding under the Moore Notes. For the twelve months ending
October 31,2010, the Company paid Mr. Moore $250,000 in principal and $130,000
in interest. As of October 31, 2010, the Company was not in default under
the terms of the Moore Agreement.
Senior
Convertible Promissory Notes
Effective
June 18, 2009, the Company entered into a Note Purchase Agreement with certain
accredited investors, pursuant to which such investors acquired senior
convertible promissory notes of the Company in the aggregate principal face
amount of $1,131,353, for an aggregate net purchase price of $961,650. At
October 31, 2010, the Company had repaid $1,042,529 of these notes and $88,824
in principal value remained outstanding.
Junior
Subordinated Convertible Promissory Notes
Additionally,
during October 2009, the company entered into Bridge Note agreements whereby
certain accredited investors acquired junior subordinated convertible promissory
in the aggregate face amounts of approximately $2.1 million for aggregate net
purchase prices of approximately $1.8 million. As of October 31, 2010, all
of these October 2009 Bridge Notes had been repaid or converted into the
Company’s common stock as described below.
F-11
During
the year ended October 31, 2010, we issued to certain accredited investors (i)
junior unsecured convertible promissory notes in the aggregate principal face
amount of approximately $1,462,000 for an aggregate net purchase price of
approximately $1,255,000 and (ii) warrants to purchase 3,270,955 shares of our
common stock at original exercise prices ranging from $0.17 to $0.25 per share,
subject to adjustments upon the occurrence of certain events. As a result
of the latest round of equity financing with Optimus in September 2010, under
the Series B Preferred Stock Purchase Agreement (see Note 11 – Shareholders’
Equity), the Company issued an additional 616,136 warrants to these bridge note
holders due to a decrease in the exercise price of their warrants, to $0.15 per
share. The company recognized non-cash warrant expense in the income statement
for all additional warrants issued to bridge note holders as a result of the
above equity financing (See Note 6 for additional information). The bridge notes
were issued with original issue discounts ranging from 6% to 18% and are
convertible into shares of our common stock. These notes mature on or
before May 31, 2011.
During
the twelve months ended October 31, 2010, the company repaid a total of
approximately $1,542,000 in principal value and converted $2,420,000 in
principal value into 14,237,489 shares of our common stock. At October 31,
2010, approximately $777,000 in principal value remains and is classified as a
current liability on the balance sheet. The indebtedness represented by
these bridge notes is expressly subordinate to our currently outstanding senior
secured indebtedness (approximately $89,000 at October 31, 2010).
As of
October 31, 2010, all Bridge Notes were originally issued with an original issue
discounts ranging from 6% to 18%. Each Investor paid between $0.82 and $.94 for
each $1.00 of principal amount of notes purchased at the closing. The bridge
notes are convertible into shares of the Company’s common stock at an exercise
price contingent on the completion of an equity financing. As a result of the
latest round of equity financing with Optimus in September 2010, under the
Series B Preferred Stock Purchase Agreement (see Note 11 – Shareholders’
Equity), all the outstanding bridge notes, at October 31, 2010, are convertible
into shares of the Company’s common stock at an exercise price of $0.15 per
share. For every dollar invested, each Investor received warrants to
purchase 2 ½ shares of common stock (the “Bridge Warrants”) subject to
adjustments upon the occurrence of certain events as more particularly described
below and in the form of Warrant. As of October 31, 2010 all Bridge Note
warrants have an exercise price of $.15 per share. The Bridge Notes may be
prepaid in whole or in part at the option of the Company without penalty at any
time prior to the Maturity Date. The warrants may be exercised on a cashless
basis under certain circumstances.
We refer
to all Senior Convertible Promissory Notes and Junior Subordinated Convertible
Promissory Notes as “Bridge Notes”. Activity
related to the Bridge Notes from issuance is as follows:
Bridge
Note – Principal Value - Issued
|
$
|
4,740,058
|
||
Principal
payments on Bridge Notes
|
(1,542,531
|
)
|
||
Bridge
Note Conversions
|
(2,420,373
|
)
|
||
Original
Issue Discount, net of accreted interest
|
(21,937
|
)
|
||
Fair
Value of Attached Warrants at issuance
|
(1,652,547
|
)
|
||
Fair
Value of Embedded Derivatives at issuance
|
(2,158,689
|
)
|
||
Accreted
interest on embedded derivative and warrant liabilities
|
3,726,446
|
|||
Convertible
Bridge Notes- as of October 31, 2010
|
$
|
670,428
|
||
Embedded
Derivatives Liability at October 31, 2010
|
81,028
|
|||
Convertible Bridge
Notes and fair value of embedded derivative
|
$
|
751,456
|
BioAdvance
Note
BioAdvance
Biotechnology Greenhouse of Southeastern Pennsylvania Notes (“BioAdvance”)
received notes from the Company for $10,000 dated November 13, 2003 and $40,000
dated December 17, 2003 that were each due on the fifth anniversary date
thereof. During November 2009, the Company paid $14,788 in full payment of the
November 13, 2003 note and BioAdvance agreed to extend the remaining note.
During the twelve months ending October 31, 2010, the Company paid $10,000 in
accrued interest on the remaining note. As of October 31, 2010, the Company owes
approximately $40,000 in principal and $11,000 in interest to BioAdvance. The
terms of the outstanding note calls for accrual of 8% interest per annum on the
unpaid principal.
F-12
6.
DERIVATIVES
The table
below lists the Company’s derivative instruments as of October 31,
2010:
Description
|
Principal
|
Original
Issue
Discount
|
Warrant
Liability
|
Embedded
Derivative
Liability
|
||||||||||||
Bridge
Note 1-June 18, 2009
|
$ | 1,131,353 | $ | 169,703 | $ | 250,392 | $ | 711,258 | ||||||||
Bridge
Note II & III-October 26 & 30, 2009
|
2,147,059 | 322,059 | 690,119 | 868,388 | ||||||||||||
Optimus
September 24, 2009
|
- | - | 3,587,625 | - | ||||||||||||
Other
outstanding warrants
|
- | - | 12,785,695 | - | ||||||||||||
Total Valuation at Origination
|
3,278,412 | 491,762 | 17,313,831 | 1,579,646 | ||||||||||||
Change
in fair value
|
- | - | (5,352,697 | ) | (493,132 | ) | ||||||||||
Accreted
interest
|
- | (123,846 | ) | - | - | |||||||||||
Total
Valuation as of October 31, 2009
|
$ | 3,278,412 | $ | 367,916 | $ | 11,961,734 | $ | 1,086,514 | ||||||||
Bridge
Notes IV-December 1, 2009 through January 31. 2010
|
555,882 | 83,382 | 207,617 | 164,400 | ||||||||||||
Bridge
Note I- Extension of Maturity Date
|
- | - | 202,500 | 103,400 | ||||||||||||
Change
in fair value
|
- | - | 1,995,372 | (905,259 | ) | |||||||||||
Accreted
interest
|
- | (225,321 | ) | - | - | |||||||||||
Exercise
of Common Stock Warrants
|
- | - | (1,702,073 | ) | - | |||||||||||
Total
Valuation as of January 31, 2010
|
$ | 3,834,294 | $ | 225,977 | $ | 12,665,150 | $ | 449,055 | ||||||||
Bridge
Note V
|
640,307 | 97,807 | 229,619 | 271,554 | ||||||||||||
Change
in fair value
|
- | - | 5,363,854 | 421,404 | ||||||||||||
Accreted
interest
|
- | (251,188 | ) | - | - | |||||||||||
Exercise
of common stock warrants
|
- | - | (1,790,823 | ) | - | |||||||||||
Note
Payoffs
|
(1,040,177 | ) | (4,222 | ) | - | (64,354 | ) | |||||||||
Total
Valuation as of April 30, 2010
|
3,434,424 | 68,374 | 16,467,800 | 1,077,659 | ||||||||||||
Issuance
of Optimus Warrants
|
- | - | 6,856,946 | - | ||||||||||||
Bridge
Note Conversions
|
(2,420,373 | ) | - | - | (701,718 | ) | ||||||||||
Change
in fair value
|
- | - | (3,866,801 | ) | (260,843 | ) | ||||||||||
Accreted
interest
|
- | (50,842 | ) | - | - | |||||||||||
Exercise
of common stock warrants
|
- | - | (1,475,758 | ) | - | |||||||||||
Note
Payoffs
|
(88,236 | ) | (12,665 | ) | ||||||||||||
Total
Valuation as of July 31, 2010
|
$ | 925,815 | $ | 17,532 | $ | 17,982,187 | $ | 102,433 | ||||||||
Bridge
Note VI
|
265,457 | 25,457 | 72,300 | 39,416 | ||||||||||||
Note
Payoff
|
(414,118 | ) | - | - | (46,945 | ) | ||||||||||
Issuance
of Warrants
|
- | - | 1,042,559 | - | ||||||||||||
Accreted
Interest
|
- | (21,052 | ) | - | - | |||||||||||
Exercise
of Warrants
|
- | - | (4,156,797 | ) | - | |||||||||||
Change
in FV
|
- | - | (1,934,055 | ) | (13,876 | ) | ||||||||||
Total
Valuation as of October 31, 2010
|
$ | 777,154 | $ | 21,937 | $ | 13,006,194 | $ | 81,028 |
Warrants
As of
October 31, 2010, there were outstanding warrants to purchase 103,139,628 shares
of our common stock with exercise prices ranging from $0.15 to $0.287 per share.
Information on the outstanding warrants is as follows:
Type
|
ExercisePrice
|
Amount
|
Expiration Date
|
Type
|
|||||||
Common
Stock Purchase Warrant
|
$ | 0.15 | 72,025,662 |
February
2011 – October 2012
|
2007
Securities Purchase Agreement
|
||||||
Common
Stock Purchase Warrant
|
$ | 0.15 | 14,813,851 |
June
2014 – August 2015
|
Bridge
Notes
|
||||||
Common
Stock Purchase Warrant
|
$0.1952 - $0.287 | 497,174 |
February
2011 – February 2012
|
Vendor
& Other
|
|||||||
Subtotal
|
87,336,687 | ||||||||||
Common
Stock Purchase Warrant
|
(1) | 15,802,941 |
July
2013
|
Optimus
Preferred Stock Purchase Agreement (7/19/2010)
|
|||||||
Grand
Total
|
103,139,628 |
F-13
(1)
For purposes of this warrant, exercise price means an amount per warrant
share equal to the closing sale price of a share of common stock on the
applicable tranche notice date.
Warrant
Liability/Embedded Derivative Liability
The fair
value of the Warrants and Embedded Derivatives are estimated using the BSM
model. The fair value of the Warrants and Embedded Derivatives are
estimated using an adjusted BSM model. The Company computes valuations, each
quarter, using the BSM model for each derivative instrument to account for the
various possibilities that could occur due to changes in the inputs to the BSM
model as a result of contractually-obligated changes (for example, changes in
strike price to account for down-round provisions). The Company effectively
weights each calculation based on the likelihood of occurrence to determine the
value of the derivative at the reporting date. As of October 31, 2010,
the fair value of the Warrants and Embedded Derivatives were determined to be
approximately $13.0 million and $81,000, respectively. As of October 31,
2009, the fair value of the Warrants and Embedded Derivatives were determined to
be approximately $12.0 million and $1.0 million, respectively We increased
income approximately $446,000 for net changes in the fair value of the common
stock warrant liability and embedded derivative liability for year ending
October 31, 2010. We increased income approximately $5.8 million for net
changes in the fair value of the common stock warrant liability and embedded
derivative liability for year ending October 31, 2009.
The
repricing (“ratchet effect”) of our warrants both in January and September 2010
also increased the company’s warrant liability for the year ending October 31,
2010. As a result of the increase in warrant liability due to the ratchet
effect, the company issued approximately 21.8 million additional warrants to
existing warrant holders. These warrants were recorded at their fair values at
issuance and will continue to be recorded at fair value each subsequent balance
sheet date. Any change in value between reporting periods will be recorded at
each reporting date. These warrants will continue to be reported until such time
as they are exercised, expire, or mature at which time these derivatives will be
adjusted to fair value and reclassified from liabilities to equity. Of the total
21.8 million additional warrants, approximately 3.6 million warrants were issued
to bridge note holders. The company recognized non-cash warrant expense of
approximately $206,000, for the year ending October 31, 2010, related to the
fair value of the additional warrants issued to bridge note holders because they
were not contractually obligated (no anti-dilution provisions in their warrant
agreements) to receive additional warrants due to ratchet effects.
7.
STOCK OPTIONS:
2004 Stock Option
Plan
In
November 2004, our board of directors adopted and stockholders approved the 2004
Stock Option Plan (“2004 Plan”). The 2004 Plan provides for the grant of
options to purchase up to 2,381,525 shares of our common stock to employees,
officers, directors and consultants. Options may be either “incentive stock
options” or non-qualified options under the Federal tax laws. Incentive stock
options may be granted only to our employees, while non-qualified options may be
issued, in addition to employees, to non-employee directors, and consultants.
Except as determined by the Administrator at the time of the grant of the
Options, a participant Options vest over four years, twenty-five percent of the
granted amount on or after the first year anniversary of the date of the
granting of an Options and the balance to vest an additional one twelfth of the
Options granted for each additional three-month period following the first
anniversary over a next three years.
The 2004
Plan is administered by “disinterested members” of the board of directors or the
Compensation Committee, who determine, among other things, the individuals who
shall receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market price value per
share of common stock on the date the option is granted. The per share exercise
price of the common stock subject to a non-qualified option may be established
by the board of directors, but shall not, however, be less than 85% of the fair
market value per share of common stock on the date the option is granted. The
aggregate fair market value of common stock for which any person may be granted
incentive stock options which first become exercisable in any calendar year may
not exceed $100,000 on the date of grant.
We must
grant options under the 2004 Plan within ten years from the effective date of
the 2004 Plan. The effective date of the Plan was November 12, 2004. Subject to
a number of exceptions, holders of incentive stock options granted under the
Plan cannot exercise these options more than ten years from the date of grant.
Options granted under the 2004 Plan generally provide for the payment of the
exercise price in cash and may provide for the payment of the exercise price by
delivery to us of shares of common stock already owned by the optionee having a
fair market value equal to the exercise price of the options being exercised, or
by a combination of these methods. Therefore, if it is provided in an optionee’s
options, the optionee may be able to tender shares of common stock to purchase
additional shares of common stock and may theoretically exercise all of his
stock options with no additional investment other than the purchase of his
original shares. As of October 31, 2010, 2,319,025 options were granted under
the 2004 plan.
F-14
2005 Stock Option
Plan
In June
2006, our board of directors adopted and stockholders approved on June 6, 2006,
the 2005 Stock Option Plan (“2005 Plan”).
The 2005
Plan provides for the grant of options to purchase up to 5,600,000 shares of our
common stock to employees, officers, directors and consultants. Options may be
either “incentive stock options” or non-qualified options under the Federal tax
laws. Incentive stock options may be granted only to our employees, while
non-qualified options may be issued to non-employee directors, consultants and
others, as well as to our employees.
The 2005
Plan is administered by “disinterested members” of the board of directors or the
compensation committee, who determine, among other things, the individuals who
shall receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market value per share of
common stock on the date the option is granted. The per share exercise price of
the common stock subject to a non-qualified option may be established by the
board of directors, but shall not, however, be less than 85% of the fair market
value per share of common stock on the date the option is granted. The aggregate
fair market value of common stock for which any person may be granted incentive
stock options which first become exercisable in any calendar year may not exceed
$100,000 on the date of grant.
We must
grant options under the 2005 Plan within ten years from the effective date of
the 2005 Plan. The effective date of the Plan was January 1, 2005. Subject to a
number of exceptions, holders of incentive stock options granted under the 2005
Plan cannot exercise these options more than ten years from the date of grant.
Options granted under the 2005 Plan generally provide for the payment of the
exercise price in cash and may provide for the payment of the exercise price by
delivery to us of shares of common stock already owned by the optionee having a
fair market value equal to the exercise price of the options being exercised, or
by a combination of these methods. Therefore, if it is provided in an optionee’s
options, the optionee may be able to tender shares of common stock to purchase
additional shares of common stock and may theoretically exercise all of his
stock options with no additional investment other than the purchase of his
original shares. As of October 31, 2010 there were 4,983,667 options granted
under the 2005 plan.
On November 12, 2004, in connection with the
recapitalization,(see Note 10), the options granted under the 2002 option plan
were canceled, and employees and consultants were granted options of Advaxis
under the 2004 plan. The cancellation and replacement had no accounting
consequence since the aggregate intrinsic value of the options immediately after
the cancellation and replacement was not greater than the aggregate intrinsic
value immediately before the cancellation and replacement, and the ratio of the
exercise price per share to the fair value per share was not reduced.
Additionally, the original options were not modified to accelerate vesting or
extend the life of the new options. The table provided in this Note 7
reflects the options on a post recapitalization basis.
2009 Stock Option
Plan
Our board
of directors adopted the 2009 Stock Option Plan (the “2009 Plan”), effective
July 21, 2009, and was approved by our shareholders in June 2010. An
aggregate of 20,000,000 shares (subject to adjustment by the compensation
committee) are reserved for issuance upon the exercise of options granted under
the plan. As of October 31, 2010, options to purchase 19,209,732
shares of our common stock have been granted under the 2009 Plan. The
purpose of this plan is to, among other things, (i) comply with certain
exclusions from the limitations of Section 162(m) of the Internal Revenue Code
of 1986, which we refer to as the Code, and (ii) comply with the incentive stock
options rules under Section 422 of the Code. The maximum number of shares
of common stock to which options may be granted to any one individual under the
2009 Plan is 6,000,000 (subject to adjustment by the compensation
committee).
A summary
of the grants, cancellations and expirations (none were exercised) of the
Company’s outstanding options for the periods starting with October 31, 2008
through October 31, 2010 is as follows:
Shares
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Life In
Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding
as of October 31, 2008
|
8,812,841
|
$
|
0.22
|
6.3
|
$
|
167,572
|
||||||||||
Granted
|
10,150,000
|
0.10
|
9.8
|
294,500
|
||||||||||||
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
Cancelled
or Expired
|
(631,250
|
)
|
0.13
|
7.5
|
(15,000
|
)
|
||||||||||
Outstanding
as of October 31, 2009
|
18,331,591
|
0.16
|
6.0
|
$
|
306,500
|
|||||||||||
Granted
|
11,075,000
|
0.16
|
9.8
|
42,500
|
||||||||||||
Exercised
|
(306,000
|
)
|
0.09
|
8.1
|
(16,860
|
)
|
||||||||||
Cancelled
or Expired
|
(2,633,167
|
)
|
0.12
|
8.6
|
(104,912
|
)
|
||||||||||
Outstanding
as of October 31, 2010
|
26,467,424
|
0.16
|
7.4
|
415,967
|
||||||||||||
Vested
& Exercisable at October 31, 2010
|
14,157,007
|
$
|
0.17
|
6.0
|
$
|
283,217
|
F-15
The fair
value of options granted for the year ended October 31, 2010 amounted to
$1,409,841
The
following table summarizes significant ranges of outstanding and exercisable
options as of October 31, 2010 (number outstanding and exercisable in
thousands):
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||||||||||||||
Range of
Exercise
Prices
|
Number
Outstanding
(000’s)
|
Weighted-
Average
Remaining
Contractual
Life (in Years)
|
Weighted-
Average
Exercise
Price per
Share
|
Aggregate
Intrinsic
Value
|
Number
Exercisable
(000’s)
|
Weighted-
Average
Exercise
Price per
Share
|
Aggregate
Intrinsic
Value
|
|||||||||||||||||||||||
$
|
0.09-0.11
|
8,133
|
8.3
|
0.10
|
$
|
356,667
|
5,283
|
$
|
0.10
|
$
|
260,833
|
|||||||||||||||||||
0.12-0.13
|
1,750
|
5.2
|
$
|
0.13
|
42,500
|
583
|
0.13
|
14,167
|
||||||||||||||||||||||
0.14-0.17
|
11,281
|
3.0
|
0.15
|
16,800
|
3,055
|
0.15
|
8,217
|
|||||||||||||||||||||||
0.18-0.21
|
606
|
3.3
|
0.19
|
0
|
539
|
0.19
|
0
|
|||||||||||||||||||||||
0.22-0.25
|
1,308
|
4.1
|
0.22
|
0
|
1,308
|
0.22
|
0
|
|||||||||||||||||||||||
0.26-0.29
|
3,067
|
4.0
|
0.28
|
0
|
3,067
|
0.28
|
0
|
|||||||||||||||||||||||
0.30-0.43
|
322
|
2.3
|
0.37
|
0
|
322
|
0.37
|
0
|
|||||||||||||||||||||||
Total
|
26,467
|
5.0
|
$
|
0.16
|
$
|
415,967
|
14,157
|
$
|
0.17
|
$
|
283,217
|
The
aggregate intrinsic value in the preceding table represents the total pretax
intrinsic value, based on options with an exercise price less than the Company’s
closing stock price of $0.15 as of October 31, 2010.
As of
October 31, 2010, there was approximately $1,150,000 of unrecognized
compensation cost related to non-vested stock option awards, which is expected
to be recognized over a remaining average vesting period of 2.3
years.
A summary of the status of the Company’s nonvested shares as
of October 31, 2007, and changes during the years ended
October 31, 2009 and 2008 are presented below:
|
Number of
Shares
|
Weighted
Average
Exercise
Price at
Grant
Date
|
Weighted Average
Remaining
Contractual Term
(in years)
|
|||||||||
Non-vested
shares at October 31, 2008
|
1,413,278 | $ | 0.18 | 7.5 | ||||||||
Options
granted
|
6,766,667 | $ | 0.10 | 9.3 | ||||||||
Options
vested
|
(1,459,528 | ) | $ | 0.19 | 6.0 | |||||||
Non-vested
shares at October 31, 2009
|
6,720,417 | $ | 0.10 | 8.7 | ||||||||
Options
Granted
|
10,108,333 |
$
|
0.14 | 2.8 | ||||||||
Options
Vested
|
(4,518,333 | ) |
$
|
0.10 | 1.0 | |||||||
Non-vested
shares at October 31, 2010
|
12,310,417 |
$
|
0.13 | 2.3 |
8. COMMITMENTS AND
CONTINGENCIES :
University
of Pennsylvania
On May
10, 2010, the Company and Penn entered into a second amendment (the “ Second Amendment
Agreement ”) to the 20-year exclusive worldwide license agreement.
Pursuant to the Second Amendment Agreement, the Company acquired exclusive
licenses for an additional 27 patents related to the Company’s proprietary Listeria vaccine technology,
some of which expire as late as 2023. As per the terms of the Second Amendment
Agreement, the Company acknowledgedthat it owes Penn approximately $249,000 in
patent expenses and $130,000 in sponsored research agreement fees. As of
October 31, 2010, all such payments had been made to Penn.
In addition, the Company has exercised an
option for the rights to seven additional patent dockets at an option exercise
fee of $10,000 per patent docket ($70,000 in the aggregate). Pursuant to the
terms of the Second Amendment Agreement, Penn has the option to receive the
option exercise fee in the form of a cash payment in the amount of $70,000,
shares of the Company common stock valued at $140,000 (based on a price per
share of the Company’s most recently completed financing round) or a combination
of cash and Company common stock (provided that the stock component is not less
than 25% of the total payment). Penn elected to receive payment of the option
exercise fee in the form of $35,000 in cash and $70,000 in company common stock
( 388,889 shares of common stock were issued at a price of $0.18 per
share).
F-16
During
the year ending October 31, 2010, the Company paid in aggregate $657,049 to Penn
under these agreements.
Numoda
On June
19, 2009 we entered into a Master Agreement and on July 8, 2009 we entered into
a Project Agreement with Numoda, a leading clinical trial and logistics
management company, to oversee Phase II clinical activity with ADXS11-001 for
the treatment of invasive cervical cancer and CIN. Numoda will be
responsible globally for integrating oversight and logistical functions with the
clinical research organizations, contract laboratories, academic laboratories
and statistical groups involved. The scope of this agreement covers over
three years and is estimated to cost approximately $11.2 million for both
trials. Per the agreement, the Company is permitted to pay a portion of
outstanding charges to Numoda in the form of the Company’s common stock and
during May 2010, the Company issued 3,500,000 shares of its common stock to an
affiliate of Numoda in satisfaction of $595,000 in services rendered by Numoda
to the Company under the Master Agreement. The Company has recorded deferred
expenses on the balance sheet for this amount as well as any cash payments made
to Numoda and amortizes this amount to expense over the life of the
agreement. For the year ending October 31, 2010 the company paid Numoda
approximately $3.2 million. At October 31, 2010, the balance in deferred
expenses was approximately $233,000.
Other
Pursuant
to a Clinical Research Service Agreement, the Company is obligated to pay
Pharm–Olam International for service fees related to our Phase I clinical trial.
As of October 31, 2010, the Company has an outstanding balance of $219,131 on
this agreement, which is included in Accounts Payable as of October 31,
2010.
We are party to a consulting agreement with
The Sage Group, a health-care strategy consultant assisting us with a program to
commercialize our vaccines. The initial agreement was entered into in
January 2009 and subsequently amended on July 22, 2009. Pursuant to the
terms of agreement, as amended, we have agreed to pay Sage (i) $5,000 per month
until an aggregate of $120,000 has been paid to Sage under the consulting
agreement and (ii) a 5% commission for certain transactions if completed in the
first 24 months of the term of the agreement, reduced to 2% if completed in the
12 months thereafter. The Sage Group has been paid approximately $56,000 through
October 31, 2010.
The
Company operates under a month to month lease for its laboratory and office
space. There are no aggregate future minimum payments due as of October 31,
2010.
Moore Employment Agreement and
Option Agreements. We are party to an employment agreement with Mr.
Moore, dated as of August 21, 2007 (memorializing an oral agreement dated
December 15, 2006), that provides that he will serve as our Chairman of the
Board and Chief Executive Officer for an initial term of two years. For so
long as Mr. Moore is employed by us, Mr. Moore is also entitled to nominate one
additional person to serve on our board of directors. Following the
initial term of employment, the agreement was renewed for a one year term, and
is automatically renewable for additional successive one year terms, subject to
our right and Mr. Moore’s right not to renew the agreement upon at least 90
days’ written notice prior to the expiration of any one year term.
Under the
terms of the agreement, Mr. Moore was entitled to receive a base salary of
$250,000 per year, subject to increase to $350,000 per year, his current salary,
upon our successful raise of at least $4.0 million (which condition was
satisfied on November 1, 2007) and subject to annual review for increases by our
board of directors in its sole discretion. The agreement also provides
that Mr. Moore is entitled to receive family health insurance at no cost to
him. Mr. Moore’s employment agreement does not provide for the payment of
a bonus.
In
connection with our hiring of Mr. Moore, we agreed to grant Mr. Moore up to
1,500,000 shares of our common stock, of which 750,000 shares were issuable on
November 1, 2007 upon our successful raise of $4.0 million and 750,000 shares
are issuable upon our successful raise of an additional $6.0 million (which
condition was satisfied in January 2010 and the shares were then issued in June
2010). In addition, on December 15, 2006, we granted Mr. Moore options to
purchase 2,400,000 shares of our common stock. Each option is exercisable
at $0.143 per share (which was equal to the closing sale price of our common
stock on December 15, 2006) and expires on December 15, 2016. The options
vest in 24 equal monthly installments. On July 21, 2009, we granted Mr.
Moore options to purchase 2,500,000 shares of our common stock. Each
option is exercisable at $0.10 per share (which was equal to the closing sale
price of our common stock on July 21, 2009) and expires on July 21, 2019.
One-third of these options vested on the grant date, and the remaining vest in
one third installments on the first and second anniversary of the grant. On
October 14, 2010, we granted Mr. Moore options to purchase 2,000,000 shares of
our common stock. Each option is exercisable at $0.15 per share. These options
vest over a three year period beginning one year from the grant
date.
We have
also agreed to grant Mr. Moore 1,500,000 shares of our common stock if the price
of common stock (adjusted for any splits) is equal to or greater than $0.40 for
40 consecutive business days. Pursuant to the terms of his employment
agreement, all options will be awarded and vested upon a merger of the company
which is a change of control or a sale of the company while Mr. Moore is
employed. In addition, if Mr. Moore’s employment is terminated by us, Mr.
Moore is entitled to receive severance payments equal to one year’s salary at
the then current compensation level.
F-17
Mr. Moore has agreed to
refrain from engaging in certain activities that are competitive with us and our
business during his employment and for a period of 12 months thereafter
under certain circumstances. In addition, Mr. Moore is subject to a
non-solicitation provision for 12 months after termination of his
employment.
Rothman Employment Agreement and
Option Agreements. We previously entered into an employment
agreement with Dr. Rothman, Ph.D., dated as of March 7, 2005, that provided that
he would serve as our Vice President of Clinical Development for an initial
term of one year. Dr. Rothman’s current salary is $305,000, consisting of
$275,000 in cash and $30,000 in stock, payable in our common stock, issued on a
semi-annual basis, based on the average closing stock price for such six month
period, with a minimum price of $0.20. While the employment agreement has
expired and has not been formally renewed in accordance with the agreement, Dr.
Rothman remains employed by us and is currently our Executive V.P. of
Clinical and Scientific Operations.
In
addition, on March 1, 2005, we granted Dr. Rothman options to purchase 360,000
shares of our common stock. Each option is exercisable at $0.287 per share
(which was equal to the closing sale price of our common stock on March 1, 2005)
and expires on March 1, 2015. All of these options have vested. On
March 29, 2006, we granted Dr. Rothman options to purchase 150,000 shares of our
common stock. Each option is exercisable at $0.26 per share (which was
equal to the closing sale price of our common stock on March 29, 2006) and
expires on March 29, 2016. One-fourth of these options vested on the first
anniversary of the grant date, and the remaining vest in 12 equal quarterly
installments. On February 15, 2007, we granted Dr. Rothman options to
purchase 300,000 shares of our common stock. Each option is exercisable at
$0.165 per share (which was equal to the closing sale price of our common stock
on February 15, 2007) and expires on February 15, 2017. One-fourth of
these options vested on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. Pursuant to the terms
of the 2005 plan, at least 75% of Dr. Rothman’s options will be vested upon a
merger of the company which is a change of control or a sale of the company
while Dr. Rothman is employed, unless the administrator of the plan otherwise
allows for all options to become vested. On July 21, 2009, we granted Mr.
Rothman options to purchase 1,750,000 shares of our common stock. Each option is
exercisable at $0.10 per share (which was equal to the closing sale price of our
common stock on July 21, 2009) and expires on July 21, 2019. One-third of
these options vested on the grant date, and the remaining vest, in one third
installments on the first and second anniversary of the grant. On
October 14, 2010, we granted Dr. Rothman options to purchase 2,250,000 shares of
our common stock. Each option is exercisable at $0.15 per share. These
options vest over a three year period beginning one year from the grant
date.
Dr.
Rothman has agreed to refrain from engaging in certain activities that are
competitive with us and our business during his employment and for a period
of 18 months thereafter under certain circumstances. In addition, Dr.
Rothman is subject to a non-solicitation provision for 18 months after
termination of his employment.
9.
INCOME TAXES:
The
Company has a net operating loss carry forward of approximately $20,095,366 and
$19,466,268 at October 31, 2010 and 2009, respectively, available to offset
taxable income through 2030. Due to change in control provisions, the
Company’s utilization of these losses may be limited. The tax effects of loss
carry forwards give rise to a deferred tax asset and a related valuation
allowance at October 31, as follows:
2010
|
2009
|
|||||||
Net
operating loss carryforwards-federal
|
$
|
8,038,146
|
$
|
7,786,507
|
||||
Stock
based compensation
|
1,202,168
|
990,700
|
||||||
Research
and development tax credits
|
-
|
216,134
|
||||||
Less
valuation allowance
|
(9,240,314
|
)
|
(8,993,341
|
)
|
||||
Deferred
tax asset
|
$
|
-
|
$
|
-
|
The
difference between income taxes computed at the statutory federal rate of 34%
and the provision for income taxes relates to the following:
Year ended
October 31,
2010
|
Year ended
October 31,
2009
|
Period from
March 1, 2002
(inception) to
October 31,
2010
|
||||||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
||||||
-
|
%
|
-
|
%
|
-
|
%
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In a
letter dated November 13, 2008 from the New Jersey Economic Development
Authority we were notified that our application for the New Jersey Technology
Tax Certificate Transfer Program was preliminarily approved. Under the State of
New Jersey NOL Transfer Program for small business we received a net cash amount
of $922,020 on December 12, 2008 from the sale of our State Net Operating Losses
(“NOL”) through December 31, 2007 of $1,084,729. In January 2010, the company
received a net cash amount of $278,978 from the sale of some of our State Net
Operating Losses (“NOL”) through December 31, 2008. The company plans to sell
its Net Operating Losses and research tax credits for the 2009 fiscal year under
the same State of New Jersey Program for small business.
F-18
We
adopted ASC 740, Income Taxes, formerly Financial Interpretation Number 48,
“Accounting for Uncertain Tax Positions” (“FIN 48”) on November 1, 2007.
ASC 740 clarifies the accounting for uncertainty in income taxes recognized in
an enterprise’s financial statements in accordance with FASB Statement
No. 109,” Accounting for Income Taxes.” ASC 740 prescribes a recognition
threshold and measurement of a tax position taken or expected to be taken in a
tax return. We did not establish any additional reserves for uncertain tax
liabilities upon adoption of ASC 740. There were no adjustments for uncertain
tax positions in the current year.
We will
account for interest and penalties related to uncertain tax positions, if any,
as part of our provision for federal and state income taxes.
We
do not expect that the amounts of unrecognized benefits will change
significantly within the next 12 months.
We
are no longer subject to audit under the statute of limitations by the Internal
Revenue Service and state jurisdictions for 2006 through 2009.
10.
CAPITALIZATION
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;. 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. 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.
On
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.
F-19
Pursuant
to a Securities Purchase Agreement dated February 2, 2006 ($1,500,000 principal
amount) and March 8, 2006 ($1,500,000 principal amount) we issued to Cornell
Capital Partners, LP (“Cornell”) $3,000,000 principal amount of the Company’s
Secured Convertible Debentures due February 1, 2009 (the “Debentures”) at face
amount, and five year Warrants to purchase 4,200,000 shares of Common Stock at
the price of $0.287 per share and five year B Warrants to purchase 300,000
shares of Common Stock at a price of $0.3444 per share.
The
Debentures were convertible at a price equal to the lesser of (i) $0.287 per
share (“Fixed Conversion Price”), or (ii) 95% of the lowest volume weighted
average price of the Common Stock on the market on which the shares are listed
or traded during the 30 trading days immediately preceding the date of
conversion (“Market Conversion Price”). Interest was payable at maturity at the
rate of 6% per annum in cash or shares of Common Stock valued at the conversion
price then in effect.
Cornell agreed that (i) it would not convert
the Debenture or exercise the Warrants if the effect of such conversion or
exercise would result in its and its affiliates’ holdings of more than 4.9% of
the outstanding shares of Common Stock, (ii) neither it nor its affiliates will
maintain a short position or effect short sales of the Common Stock while the
Debentures are outstanding, and (iii) no more than $300,000 principal amount of
the Debenture could be converted at the Market Conversion Price during a
calendar month.
On August
24, 2007, we issued and sold an aggregate of $600,000 principal amount
promissory notes bearing interest at a rate of 12% per annum and warrants to
purchase an aggregate of 150,000 shares of our common stock to three investors
including Thomas Moore, our Chief Executive Officer. Mr. Moore invested $400,000
and received warrants for the purchase of 100,000 shares of Common Stock. The
promissory note and accrued but unpaid interest thereon are convertible at the
option of the holder into shares of our common stock upon the closing by the
Company of a sale of its equity securities aggregating $3,000,000 or more in
gross proceeds to the Company at a conversion rate which shall be the greater of
a price at which such equity securities were sold or the price per share of the
last reported trade of our common stock on the market on which the common stock
is then listed, as quoted by Bloomberg LP. At any time prior to conversion, we
have the right to prepay the promissory notes and accrued but unpaid interest
thereon. Mr. Moore converted his $400,000 bridge investment into 2,666,667
shares of common stock and 2,000,000 $0.20 Warrants based on the terms of the
Private Placement. He was paid $7,101 interest in cash.
On
October 17, 2007, pursuant to a Securities Purchase Agreement, we completed a
private placement resulting in $7,384,235.10 in gross proceeds, pursuant to
which we sold 49,228,334 shares of common stock at a purchase price of $0.15 per
share solely to institutional and accredited investors. Each investor received a
five-year warrant to purchase an amount of shares of common stock that equals
75% of the number of shares of common stock purchased by such investor in the
offering.
Concurrent
with the closing of the private placement, the Company sold for $1,996,700 to
CAMOFI Master LDC and CAMHZN Master LDC, affiliates of its financial advisor,
Centrecourt Asset Management (“Centrecourt”), an aggregate of
(i) 10,000,000 shares of Common Stock, (ii) 10,000,000 warrants
exercisable at $0.20 (prior to anti-dilution adjustments) per share, and (iii)
5-year warrants to purchase an additional 3,333,333 shares of Common Stock at a
purchase price of $0.001 per share (the “$0.001 Warrants”). The Company and the
two purchasers agreed that the purchasers would be bound by and entitled to the
benefits of the Securities Purchase Agreement as if they had been signatories
thereto. The $0.20 (prior to anti-dilution adjustments) Warrants and $0.001
Warrants contain the same terms, except for the exercise price. Both warrants
provide that they may not be exercised if, following the exercise, the holder
will be deemed to be the beneficial owner of more than 9.99% of the Company’s
outstanding shares of Common Stock. Pursuant to a consulting agreement dated
August 1, 2007 with Centrecourt with respect to the anticipated financing, in
which Centrecourt was engaged to act as the Company’s financial advisor,
Registrant paid Centrecourt $328,000 in cash and issued 2,483,333 warrants
exercisable at $0.20 (prior to anti-dilution adjustments) per share to
Centrecourt, which Centrecourt assigned to the two affiliates.
All of
the $0.20 (prior to anti-dilution adjustments) Warrants and $0.001 Warrants
provide for adjustment of their exercise prices upon the occurrence of certain
events, such as payment of a stock dividend, a stock split, a reverse split, a
reclassification of shares, or any subsequent equity sale, rights offering,
pro rata distribution,
or any fundamental transaction such as a merger, sale of all of its assets,
tender offer or exchange offer, or reclassification of its common stock. If at
any time after October 17, 2008 there is no effective registration statement
registering, or no current prospectus available for, the resale of the shares
underlying the warrants by the holder of such warrants, then the warrants may
also be exercised at such time by means of a “cashless exercise.”
In connection with the private placement, we
entered into a registration rights agreement with the purchasers of the
securities pursuant to which we agreed to file a registration statement with the
Securities and Exchange Commission with an effectiveness date within 90 days
after the final closing of the offering. The registration statement was declared
effective on January 22, 2008.
At the
closing of this private placement, we exercised our right under an agreement
dated August 23, 2007 with YA Global Investments, L.P. f/k/a Cornell Capital
Partners, L.P. (“Yorkville”), to redeem the outstanding $1,700,000 principal
amount of our Secured Convertible Debentures due February 1, 2009 owned by
Yorkville, and to acquire from Yorkville warrants expiring February 1, 2011 to
purchase an aggregate of 4,500,000 shares of our common stock. We paid an
aggregate of (i) $2,289,999 to redeem the debentures at the principal
amount plus a 20% premium and accrued and unpaid interest, and
(ii) $600,000 to repurchase the warrants.
On
September 22, 2008, Advaxis, Inc. (the “Company”) entered into a Note Purchase
Agreement (the “Agreement”) with the Company’s Chief Executive Officer, Thomas
Moore, pursuant to which the Company agreed to sell to Mr. Moore, from time to
time, one or more senior promissory notes (each a “Note” and collectively the
“Notes”) with an aggregate principal amount of up to $800,000.
F-20
The
Agreement was reviewed and recommended to the Company’s Board of Directors (the
“Board”) by a special committee of the Board and was approved by a majority of
the disinterested members of the Board. The Note or Notes, if and when issued,
will bear interest at a rate of 12% per annum, compounded quarterly, and will be
due and payable on (i) the earlier of the close of the Company’s next equity
financing resulting in gross proceeds to the Company of at least $6,000,000 (the
“Subsequent Equity Raise”) or (ii) default under the terms of the Moore
Agreement (the “Maturity Date”). The Note(s) may be prepaid in whole or in part
at the option of the Company without penalty or any time prior to the Maturity
Date.
In
consideration of Mr. Moore’s agreement to purchase the Notes, the Company agreed
that concurrently with the Subsequent Equity Raise, the Company will issue to
Mr. Moore a warrant to purchase the Company’s common stock, which will entitle
Mr. Moore to purchase a number of shares of the Company’s common stock equal to
one share per $1.00 invested by Mr. Moore in the purchase of one or more Notes.
Such warrant would contain the same terms and conditions as warrants issued to
investors in the Subsequent Equity Raise. At October 31, 2010, with the
agreement of Mr. Moore, the company had not issued these warrants to
him.
11. SHAREHOLDERS’
EQUITY:
Series
A Preferred Stock Equity Financing
For the twelve months ended October 31,
2010, the Company issued and sold 500 shares of nonconvertible, redeemable
Series A Preferred Stock (“Series A Preferred Stock”) to Optimus Life Sciences
Capital Partners LLC (“the Investor”) pursuant to the terms of a Preferred Stock
Purchase Agreement between the Company and the Investor dated September 24, 2009
(the “Series A Purchase Agreement”). The aggregate purchase price for the
shares of Series A Preferred Stock was $5,000,000 (of which the Company received
approximately $4,488,000, net of registration statement costs, commitment and
legal fees of approximately $512,000). No more shares of Series A
Preferred Stock remain available under the Series A Purchase
Agreement.
In connection with the issuance by the
Company of Series A Preferred Stock, described above, an affiliate of the
Investor exercised warrants to purchase 36,568,000 shares of the Company’s
common stock at exercise prices ranging from $0.17 to $0.20 per share. The
Company, the affiliate and the Investor also agreed to waive certain terms and
conditions in the Series A Purchase Agreement and such warrants in order to
permit the affiliate of the Investor to exercise such warrants and acquire
beneficial ownership of more than 4.99% of the Company’s common stock on the
date of exercise. As permitted by the terms of such warrants, the
aggregate exercise price of approximately $6,758,000 to be received by the
Company is payable pursuant to 4 year full recourse promissory notes bearing
interest at the rate of 2% per annum.
Series
B Preferred Stock Financing
On July
19, 2010, the Company entered into a Series B Preferred Stock Purchase Agreement
with Optimus (the “Series B Purchase Agreement”), pursuant to which the Investor
agreed to purchase, upon the terms and subject to the conditions set forth
therein and described below, up to $7.5 million of the Company’s newly
authorized, non-convertible, redeemable Series B preferred stock (“Series B
Preferred Stock”) at a price of $10,000 per share. Under the terms of the
Series B Purchase Agreement, and after the SEC has declared effective a
registration statement relating to the Warrant Shares (as defined below), the
Company may from time to time until July 19, 2013, present Optimus with a notice
to purchase a specified amount of Series B Preferred Stock. Subject to
satisfaction of certain closing conditions, the Investor is obligated to
purchase such shares of Series B Preferred Stock on the 10th trading day after
the date of the notice. The Company will determine, in its sole discretion, the
timing and amount of Series B Preferred Stock to be purchased by the Investor,
and may sell such shares in multiple tranches. The Investor will not be
obligated to purchase the Series B Preferred Stock upon the Company’s notice (i)
in the event the average closing sale price of the Company’s common stock during
the nine trading days following delivery of such notice falls below 75% of the
closing sale price of the Company’s common stock on the trading day prior to the
date such notice is delivered to the Investor, or (ii) to the extent such
purchase would result in the Company and its affiliates beneficially owning more
than 9.99% of the Company’s outstanding common stock.
On July 19, 2010, the Company issued 500
shares of Series B Preferred Stock to the Investor (“Series B Exchange Shares”)
in exchange for the 500 shares of Series A Preferred Stock issued under the
Series A Purchase Agreement so that all shares of the Company’s preferred stock
held or subsequently purchased by the Investor under the Series B Purchase
Agreement would be redeemable upon substantially identical
terms.
F-21
Pursuant
to the Series B Purchase Agreement, on July 19, 2010, the Company issued to an
affiliate of the Investor a three-year warrant to purchase up to 40,500,000
shares of the Company’s common stock (the “Warrant Shares”), at an initial
exercise price of $0.25 per share, subject to adjustment as described
below. The warrant will become exercisable on the earlier of (i) the date
on which a registration statement registering for resale the shares of common
stock issuable upon exercise of the warrant becomes effective and (ii) the first
date on which such Warrant shares are eligible for resale without limitation
under Rule 144 (assuming a cashless exercise of the warrant). The warrant
consists of and is exercisable in tranches, with a separate tranche being
created upon each delivery of a tranche notice under the Series B Purchase
Agreement. On each tranche notice date, that portion of the warrant equal to
135% of the tranche amount will vest and become exercisable, and such vested
portion may be exercised at any time during the exercise period on or after such
tranche notice date. On and after the first tranche notice date and each
subsequent tranche notice date, the exercise price of the warrant will be
adjusted to the closing sale price of a share of the Company’s common stock on
the applicable tranche notice date. The exercise price of the warrant may be
paid (at the option of the affiliate of the Investor) in cash or by its issuance
of a four-year, full-recourse promissory note, bearing interest at 2% per annum,
and secured by a specified portfolio of assets. However, such promissory note is
not due or payable at any time that (a) the Company is in default of any
preferred stock purchase agreement for Series B Preferred Stock or any warrant
issued pursuant thereto, any loan agreement or other material agreement or (b)
there are any shares of the Series B Preferred Stock issued or
outstanding.
For the
period between July 19, 2010 and October 31, 2010 the Company issued and sold
289 shares of nonconvertible, redeemable Series B Preferred Stock (“Series B
Preferred Stock”) to Optimus Life Sciences Capital Partners LLC (“the Investor”)
pursuant to the terms of the Series B Agreement between the Company and the
Investor dated July 19, 2010. The aggregate purchase price for the shares
of Series B Preferred Stock was $2,890,000 (of which the company received
$2,545,000, net of commitment and legal fees of $345,000).
In
connection with the issuance by the Company of the Series B Preferred Stock
described above, an affiliate of the Investor exercised warrants to
purchase 24,697,059 shares of the Company’s common stock at exercise prices
ranging from $0.15 to $0.17 per share. The Company, the affiliate and the
Investor also agreed to waive certain terms and conditions in the Series B
Purchase Agreement and such warrants in order to permit the affiliate of the
Investor to exercise such warrants and acquire beneficial ownership of more than
4.99% of the Company’s common stock on the date of exercise. As permitted
by the terms of such warrants, the aggregate purchase price of approximately
$3,901,500 received by the Company is payable pursuant to four year, full
recourse promissory notes bearing interest at the rate of 2% per
annum.
On
September 28, 2010, Advaxis, Inc. (the “ Company ”) issued and
sold 165 shares of Series B preferred stock (part of the 289 preferred
shares sold between July 19, 2010 and October 31, 2010) to Optimus pursuant to
the terms of the Series B Purchase Agreement. The aggregate purchase price
for the shares of Series B Preferred Stock was $1.65 million (of which the
Company received $1.505 million. The Company has agreed to pay a fee of
$140,000 to the Investor in consideration of (i) the closing of the purchase of
the Series B Preferred Stock taking place prior to 10 trading days following the
delivery of the tranche notice as required by the Purchase Agreement, (ii) the
Investor allowing the Company to increase the amount of the original tranche
notice after it was originally delivered to the Investor and (iii) the
waiver by the Investor of a closing condition under the Purchase
Agreement. As of September 28, 2010, 461 shares of Series B Preferred
Stock remained available for sale under the Series B Purchase
Agreement.
In
connection with the September 28, 2010 issuance by the Company of the Series B
Preferred Stock described above, an affiliate of Optimus exercised a warrant to
purchase 14,850,000 shares of the Company’s common stock at an exercise price of
$0.15 per share. As permitted by the terms of these warrants, the
aggregate exercise price of approximately $2,227,500 received by the Company is
payable pursuant to four-year full recourse promissory notes bearing
interest at the rate of 2% per year.
Warrants
Almost
all of our warrants (except the warrants issued to an affiliate of Optimus)
contain “full-ratchet” anti-dilution provisions originally set at $0.20 with a
term of five years. The Optimus exercise of warrants on January 11, 2010
triggered the anti dilution provisions of the warrant agreements requiring a
reset of both the price of these warrants (from $.20 to $.17) and an increase in
amount of warrants. Subsequently, the Optimus exercise of warrants on
September 28, 2010 triggered the anti-dilution provisions of the warrant
agreements requiring a reset of both the price of these warrants (from $0.17 to
$0.15) and an increase in the amount of warrants. Therefore, any future
financial offering or instrument issuance below $0.15 per share of the Company’s
common stock or warrants (subject to certain exceptions) will cause further
anti-dilution and/or repricing provisions in the above mentioned
87.4 million outstanding warrants (see table in Note 5). During September 2010,
the company issued additional warrants to bridge note holders to mirror the
“ratchet effect” warrants and repricing of the 2007 Private Placement
transaction. In September 2010, the company issued approximately 1.9 million of
such warrants to bridge note holders, valued using the BSM model, at
approximately, $206,000.
F-22
12. Fair
Value
The
authoritative guidance for fair value measurements defines fair value as the
exchange price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or the most advantageous market for
the asset or liability in an orderly transaction between market participants on
the measurement date. Market participants are buyers and sellers in the
principal market that are (i) independent, (ii) knowledgeable, (iii) able to
transact, and (iv) willing to transact. The guidance describes a fair value
hierarchy based on the levels of inputs, of which the first two are considered
observable and the last unobservable, that may be used to measure fair value
which are the following:
|
·
|
Level
1 — Quoted prices in active markets for identical assets or
liabilities
|
|
·
|
Level
2— Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are
observable or corroborated by observable market data or substantially the
full term of the assets or
liabilities
|
|
·
|
Level
3 — Unobservable inputs that are supported by little or no market activity
and that are significant to the value of the assets or
liabilities
|
In
accordance with FASB ASC 820, “Fair Value Measurements and Disclosures”, the
following table represents the Company’s fair value hierarchy for its financial
liabilities measured at fair value on a recurring basis as of October 31,
2010:
Level
2
|
||||
2010
|
||||
Fair
Value of Embedded Derivative
|
$ | 81,028 | ||
Common
Stock Warrants
|
13,006,194 | |||
Total
|
$ | 13,087,222 |
The
derivative instruments were valued using the market approach, which is
considered Level 2 because it uses inputs other than quoted prices in active
markets that are either directly or indirectly observable. Accordingly, the
derivatives were valued using the Black-Scholes model as described in Note
6.
F-23
13.
SUBSEQUENT EVENTS
Series
B Preferred Equity Financing
On
November 15, 2010, Advaxis, Inc. (the “ Company ”) issued and
sold 61 shares of Series B preferred to Optimus pursuant to the terms of the
Series B Purchase Agreement. The aggregate purchase price for the shares
of Series B Preferred Stock was $610,000 (of which the Company received
$605,000. As of November 5, 2010, 400 shares of Series B Preferred Stock
remained available for sale under the Series B Purchase Agreement.
In
connection with the November 15, 2010 issuance by the Company of the Series B
Preferred Stock described above, an affiliate of Optimus exercised a warrant to
purchase 5,312,903 shares of the Company’s common stock at an exercise price of
$0.155 per share. As permitted by the terms of these warrants, the
aggregate exercise price of approximately $823,500 received by the Company is
payable pursuant to four-year full recourse promissory notes bearing
interest at the rate of 2% per year.
On
December 30, 2010, Advaxis, Inc. (the “ Company ”) issued and
sold 72 shares of Series B preferred to Optimus pursuant to the terms of the
Series B Purchase Agreement. The aggregate purchase price for the shares
of Series B Preferred Stock was $720,000. The company received approximately
$473,000 (net of $150,000 used to repay a short-term promissory note due
Optimus, approximately $20,000 in legal and early payment fees and approximately
$77,000 in redemption fees).
On
December 30, 2010, immediately following the closing of the above Transaction,
the Company redeemed two hundred twenty-six (226) shares of Series B Preferred
Stock held by the Investor for an aggregate redemption price of $3,141,004
consisting of (i) cash in an amount of $76,622 and (ii) cancellation of certain
promissory notes issued by an affiliate of the Investor to the Company in the
aggregate amount of $3,064,382. As of December 30, 2010, 328 shares of
Series B Preferred Stock remained available for sale under the Series B Purchase
Agreement.
In
connection with the December 30, 2010 issuance by the Company of the Series B
Preferred Stock described above, an affiliate of Optimus exercised a warrant to
purchase 6,480,000 shares of the Company’s common stock at an exercise price of
$0.15 per share. As permitted by the terms of these warrants, the
aggregate exercise price of approximately $972,000 received by the Company is
payable pursuant to four-year full recourse promissory notes bearing
interest at the rate of 2% per year.
Junior
Subordinated Convertible Promissory Notes
In
November 2010, the Company entered into Bridge Note agreements whereby certain
accredited investors acquired junior subordinated convertible promissory notes
of the Company in the aggregate face amounts of approximately $432,000 for
aggregate net purchase prices of $410,000. These junior subordinated convertible
promissory notes mature in 60 days from their origination, subject to certain
provisions in the note agreement. In addition, the Company also entered
into Bridge Note agreements whereby certain accredited investors acquired junior
subordinated convertible promissory notes of the Company in the aggregate face
amounts of approximately $500,000 for aggregate net purchase prices of
$425,000. These junior subordinated convertible promissory notes
mature on or before August 31, 2011, subject to certain provisions in the note
agreement.
In
November 2010, the Company repaid five junior bridge notes that were due during
fiscal 2010, in the principal amounts of $187,582. Approximately
$206,500 in unpaid principal, due prior to October 31, 2010, remains outstanding
as of January 24, 2011.
In
January 2011, the Company entered into one Bridge Note agreement whereby an
accredited investor acquired a junior subordinated convertible promissory note
of the Company in the aggregate face amounts of approximately $352,000 for an
aggregate net purchase price of $300,000. This junior subordinated convertible
promissory note matures 9 months from its origination, subject to certain
provisions in the note agreement.
F-24