Prospectus |
Filed
pursuant to Rule 424(b)(3)
|
Registration
No. 333-162632
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ABOUT
THIS PROSPECTUS
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ii
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PROSPECTUS
SUMMARY
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1
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THE
OFFERING
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5
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RISK
FACTORS
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6
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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19
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USE
OF PROCEEDS
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21
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MARKET
PRICE OF AND DIVIDENDS ON OUR COMMON STOCK AND RELATED STOCKHOLDER
MATTERS
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21
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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21
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DESCRIPTION
OF BUSINESS
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32
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MANAGEMENT
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51
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EXECUTIVE
COMPENSATION
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55
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STOCK
OWNERSHIP
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62
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SELLING
STOCKHOLDERS
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64
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CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
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68
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DESCRIPTION
OF OUR CAPITAL STOCK
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68
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SHARES
ELIGIBLE FOR FUTURE SALE
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72
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PLAN
OF DISTRIBUTION
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73
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LEGAL
MATTERS
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75
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EXPERTS
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75
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INTERESTS
OF NAMED EXPERTS AND COUNSEL
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75
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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75
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PROSPECTUS
SUMMARY
This
summary highlights some important information from this prospectus, and it
may not contain all of the information that is important to
you. You should read the following summary together with the
more detailed information regarding us and our common stock being sold in
this offering, including “Risk Factors” and our financial statements and
related notes, included elsewhere in this prospectus.
Our
Company
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, which we
refer to as 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 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 focused our initial development efforts upon therapeutic cancer
vaccines targeting cervical cancer, its predecessor condition, cervical
intraepithelial neoplasia, which we refer to as CIN, head and neck cancer,
breast cancer, prostate cancer, and other cancers. Our lead products in
development are as follows:
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Product
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Indication
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Stage
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ADXS11-001
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Cervical
Cancer
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Phase I Company
sponsored & completed in 2007.
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Cervical
Intraepithelial Neoplasia
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Phase II Company
sponsored study anticipated to commence in early 2010.
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Cervical
Cancer
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Phase II Company
sponsored study anticipated to commence in early 2010 in India. 110
Patients with advanced cervical cancer.
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Cervical
Cancer
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Phase II The Gynecologic
Oncology Group of the National Cancer Institute may conduct a study
(timing to be determined).
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Head
& Neck Cancer
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Phase I The Cancer
Research UK (CRUK) is conducting a study of up to 45 patients (timing to
be determined).
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ADXS31-142
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Prostate
Cancer
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Phase I Company
sponsored (timing to be determined).
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ADXS31-164
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Breast
Cancer
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Phase I Company
sponsored (timing to be determined).
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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, 2009,
we had an accumulated deficit of $16,603,800, and shareholders’ deficiency
of $15,733,328.
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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
United States Food and Drug Administration, which we refer to as the
FDA. 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 receive
FDA approval, become commercially viable or profitable as a result of
these expenditures.
We
intend to continue to devote a substantial portion of our resources to the
continued pre-clinical development and optimization of our technology so
as to develop it to its full potential and to find appropriate new drug
candidates. Specifically, we intend to conduct research
relating to developing our Listeria technology
using new tumor antigens, and to develop new strains of Listeria , which may
lead to additional cancer and infectious disease products, to improve the
Listeria platform
by developing new Listeria strains that
are more suitable as live vaccine vectors, and to continue to develop the
use of the Listeria virulence
factor LLO as a component of a fusion protein based
vaccine. 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.
Recent
Developments
Preferred
Equity Financing
Pursuant
to the terms of the preferred stock purchase agreement dated September 24,
2009 with Optimus, which we refer to as the Optimus purchase agreement, on
January 11, 2010, we issued and sold 145 shares of non-convertible,
redeemable Series A preferred stock, which we refer to as our Series A
preferred stock, to Optimus. The aggregate purchase price for
the Series A preferred stock was $1.45 million (less $130,000 representing
an administrative fee and the balance of a commitment fee due and owing to
Optimus under the Optimus purchase agreement). Under the terms
of the Optimus purchase agreement, Optimus remains obligated, from time to
time until September 24, 2012, to purchase up to an additional 355 shares
of Series A 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 Optimus purchase agreement.
In
connection with the foregoing transaction, an affiliate of Optimus was
granted 33,750,000 warrants on September 24, 2009 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, Optimus exercised warrants to purchase 11,563,000 shares of
common stock at an adjusted exercise price of $0.17 per
share. We agreed with Optimus to waive certain terms and
conditions in the Optimus purchase agreement and the warrant in order to
permit the affiliate of Optimus to exercise the warrants at such adjusted
exercise price 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 exercise. As permitted by the terms
of such warrants, the aggregate exercise price of $1,965,710 received by
us is payable pursuant to a four year full recourse promissory note
bearing interest at the rate of 2% per year.
Recent
Bridge Financings
On
June 18, 2009, we completed a private placement with certain accredited
investors pursuant to which we issued (i) senior convertible promissory
notes in the aggregate principal face amount of $1,131,353, for an
aggregate net purchase price of $961,650 and (ii) warrants to purchase
2,404,125 shares of our common stock at an exercise price of $0.20 per
share (subject to adjustment upon the occurrence of certain events). We
refer to this capital raise as the senior bridge financing and the notes
and warrants issued therein as the senior bridge notes and senior bridge
warrants, respectively. In consideration for the agreement of
the holders of the senior bridge notes to extend the maturity date of such
notes to periods into February and March 2010, we issued warrants to
purchase an additional 1,228,441 shares of our common stock. In
addition, as a result of the anti-dilution protection provisions in the
senior bridge warrants, we reduced the exercise price of the senior bridge
warrants to $0.17 per share (subject to further adjustment upon the
occurrence of certain events) and issued warrants to purchase an
additional 641,039 shares of our common stock at an exercise price of
$0.17 per share (subject to adjustment upon the occurrence of certain
events). As of January 27, 2010, approximately $300,000 of
senior bridge notes remains outstanding with a maturity date of March 16,
2010.
As
of February 16, 2010, we issued to certain accredited investors (i) junior
unsecured convertible promissory notes in the aggregate principal face
amount of $2,820,588, for an aggregate net purchase price of $2,397,500
and (ii) warrants to purchase 5,993,750 shares of our common stock at an
exercise price of $0.20 per share (subject to adjustment upon the
occurrence of certain events). We refer to this capital raise
as the junior bridge financing and the notes and warrants issued therein
as the junior bridge notes and junior bridge warrants,
respectively. As a result of the anti-dilution protection
provisions in the junior bridge warrants, we reduced the exercise price of
the junior bridge warrants to $0.17 per share (subject to further
adjustment upon the occurrence of certain events) and issued warrants to
purchase an additional 972,791 shares of our common stock at an exercise
price of $0.17 per share (subject to adjustment upon the occurrence of
certain events).
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Amendment
to Moore Notes
On
February 15, 2010, we agreed to amend the terms of the approximately
$950,000 aggregate principal amount of senior promissory notes issued to
our Chief Executive Officer, Thomas A. Moore, which we refer to as the
Moore Notes, such that (i) Mr. Moore may elect, at his option, to receive
accumulated interest thereon on or after March 17, 2010 (which we expect
will amount to approximately $130,000), (ii) we will 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 will retain $200,000 of the repayment amount for investment in
our next equity financing.
The
Moore Notes bear interest at a rate of 12% per annum, compounded
quarterly, and may be prepaid in whole or in part at our option without
penalty at any time prior to maturity. In consideration of Mr.
Moore’s original agreement to purchase the Moore Notes, we agreed that
concurrently with an equity financing resulting in gross proceeds to us of
at least $6.0 million, we will issue to Mr. Moore a warrant to purchase
our common stock, which will entitle Mr. Moore to purchase a number of
shares of our common stock equal to one share per $1.00 invested by Mr.
Moore in the purchase of the Moore Notes. The terms of these
warrants were subsequently modified by our board of directors based on the
terms of the senior bridge financing increasing the number of shares
underlying the warrant from one share per $1.00 invested to two and
one-half shares. The terms of these warrants were further
modified by our board of directors to increase the number of shares
underlying the warrant from two and one-half shares per $1.00 invested to
three shares. The final terms are anticipated to contain the
same terms and conditions as warrants issued to investors in the
subsequent financing (which are currently exercisable at $0.17 per
share). As of October 31, 2009, $947,985 in notes were
outstanding and payable to Mr. Moore.
Grants
and Other Developments
On
February 9, 2010, we announced that Cancer Research UK (CRUK), the UK
philanthropy dedicated to cancer research, has agreed to fund the cost of
a clinical trial to investigate the use of ADXS11-001, our lead human
papilloma virus (HPV)-directed 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, Royal
Marsden Hospital in London, and Cardiff Hospital at the University of
Wales. Patient enrollment is slated for the latter part 2010. At such
time, enrollment officials anticipate recruiting a maximum of forty-five
(45) patients.
On
January 15, 2010 we received $278,978 from the New Jersey Economic
Development Authority. Under the State of New Jersey 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.
Effective
as of January 5, 2010, Mark J. Rosenblum was hired as Senior Vice
President, Chief Financial Officer and Secretary of the
Company. Mr. Rosenblum’s base compensation is $225,000 per
annum, with a discretionary bonus of up to 30% of his base compensation
awarded annually in March beginning in 2011. In addition, on
January 5, 2010 Mr. Rosenblum was granted options to purchase 1,000,000
shares of our common stock with an exercise price equal to the closing bid
price on the date of grant. One third of these options vested
on the date of grant, one third vests on the first anniversary of the date
of grant, and one third vests on the second anniversary of the date of
grant. Mr. Rosenblum may be eligible for additional option
grants in one year.
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On
December 15, 2009, we announced our Phase II Trial Collaboration with the
National Cancer Institute Gynecologic Oncology Group to Study ADXS11-001
in Sixty-Patient Study. We will collaborate with the Gynecologic Oncology
Group, which we refer to as the GOG, a collaborative research group of the
National Cancer Institute, which we refer to as the NCI, 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 will be conducted by GOG
investigators and largely underwritten by the NCI. The study’s patient
population is a very sick and rapidly progressive patient 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.
Between
February and December of 2009 the US, 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.
On
December 15, 2009 the survival of the patients in our Phase I trial of the
agent were determined at the scheduled three month
interval. Two patients were still alive out of the 13 patients
who were available for efficacy analysis. At that time these
patients had survived for 1,104 and 1,053 days after their initial
dose. One patient who had been alive at the prior assessment
had passed away after 1,064 days. This Phase I safety study was
not designed to assess efficacy, however the response rate was greater
than that associated with historical controls and the long survival of
these patients is noteworthy.
Our
History
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 on June 18,
1998 under the name Great Expectations and Associates, Inc. In
1999, we became a reporting company under the Securities Exchange Act of
1934, as amended. 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, which we refer to as the Share
Exchange, by and among Advaxis, the stockholders of Advaxis and
us. As a result of the Share Exchange, 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 our company from Colorado to
Delaware by merging the Colorado entity into our wholly-owned Delaware
subsidiary.
Principal
Executive Offices
Our
principal executive offices are located at Technology Centre of New
Jersey, 675 US Highway One, North Brunswick, New Jersey 08902 and our
telephone number is (732) 545-1590. We maintain a website at
www.advaxis.com
which contains descriptions of our technology, our drugs and the trial
status of each drug. The information on our website is not
incorporated into this prospectus.
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THE
OFFERING
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Shares
of common stock offered by us
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None
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Shares
of common stock which may be sold by the selling
stockholders
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A
total of 77,388,531 shares of our common stock (1)
consisting of:
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· 22,187,000
shares of our common stock underlying a warrant issued to an affiliate of
Optimus in our September 2009 preferred equity financing;
and
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· 55,201,531
shares of our common stock underlying warrants issued in connection with
our October 2007 private placement, which amount includes 8,280,281 shares
of common stock issuable as a result of antidilution
provisions.
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Use
of proceeds
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We
will not receive any proceeds from the resale of the shares of common
stock offered by the selling stockholders, as all of
such proceeds will be paid to the selling
stockholders. However, we will receive proceeds from the
exercise of the warrants held by the selling stockholders, if any, to the
extent they are not exercised on a cashless basis. If all
such remaining warrants covered by this prospectus are exercised for cash
at the current exercise price, we would receive proceeds of approximately
$13.8 million from the cash exercise of such warrants (assuming the
remaining warrants issued to an affiliate of Optimus are exercised at the
pre-adjustment exercise price of $0.20 per share), which we expect we
would use for general corporate and working capital
purposes.
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Risk
factors
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The
purchase of our common stock involves a high degree of
risk. You should carefully review and consider the “Risk
Factors” section of this prospectus for a discussion of factors to
consider before deciding to invest in shares of our common
stock.
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OTC
Bulletin Board market symbol
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ADXS.OB
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(1)
These shares represent approximately 31.9% of our currently outstanding
shares of common stock (based on 242,661,879 shares of common stock
outstanding as of January 27, 2010 on a fully diluted basis).
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·
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competition
from companies that have substantially greater assets and financial
resources than we have;
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need
for acceptance of products;
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·
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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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·
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amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
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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
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dependence
upon key personnel including key independent consultants and
advisors.
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·
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competition
from companies that have substantially greater assets and financial
resources than we have;
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·
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need
for acceptance of products;
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·
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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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·
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amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
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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
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·
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dependence
upon key personnel including key independent consultants and
advisors.
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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;
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·
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Manufacturing
costs, formulation issues, pricing or reimbursement issues, or other
factors that make the product uneconomical;
and
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The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
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significant
time and effort from our management
team;
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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.
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decreased
demand for our product candidates;
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damage
to our reputation;
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withdrawal
of clinical trial participants;
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costs
of related litigation;
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substantial
monetary awards to patients or other
claimants;
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loss
of revenues;
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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.
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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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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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the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Optimus purchase
agreement;
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general
economic conditions and trends;
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major
catastrophic events;
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sales
of large blocks of our stock;
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significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
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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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announcements
of new products or technologies, commercial relationships or other events
by us or our competitors;
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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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changes
in accounting principles; and
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discussion
of us or our stock price by the financial and scientific press and in
online investor communities.
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Inability
of the accounting professional to keep up with the complex rules resulting
from numerous financial
instruments.
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with
a price of less than $5.00 per
share;
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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.
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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;
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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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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.
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the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Optimus purchase
agreement;
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changes
in interest rates;
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significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
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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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variations
in quarterly operating results;
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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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investor
perceptions of our company and the technologies industries generally;
and
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general
economic and other national
conditions.
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statements
as to the anticipated timing of clinical studies and other business
developments;
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statements
as to the development of new
products;
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·
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expectations
as to the adequacy of our cash balances to support our operations for
specified periods of time and as to the nature and level of cash
expenditures; and
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expectations
as to the market opportunities for our products, as well as our ability to
take advantage of those
opportunities.
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Our
limited operating history and ability to continue as a going
concern;
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Our
ability to successfully develop and commercialize products based on our
therapies and the Listeria System;
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A
lengthy approval process and the uncertainty of FDA and other government
regulatory requirements may have a material adverse effect on our ability
to commercialize our applications;
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Clinical
trials may fail to demonstrate the safety and effectiveness of our
applications or therapies, which could have a material adverse effect on
our ability to obtain government regulatory
approval;
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The
degree and nature of our
competition;
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Our
ability to employ and retain qualified employees;
and
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The
other factors referenced in this prospectus, including, without
limitation, under the sections titled “Risk Factors,” “Management’s
Discussion and Analysis and Results of Operations,” and “Description of
our Business.”
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Fiscal
2009
|
Fiscal
2008
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High
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Low
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High
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Low
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|||||||||||||
First
Quarter (November 1-January 31)
|
$ | 0.06 | $ | 0.01 | $ | 0.20 | $ | 0.13 | ||||||||
Second
Quarter (February 1- April 30)
|
$ | 0.05 | $ | 0.02 | $ | 0.15 | $ | 0.09 | ||||||||
Third
Quarter (May 1 - July 31)
|
$ | 0.21 | $ | 0.04 | $ | 0.135 | $ | 0.058 | ||||||||
Fourth
Quarter (August 1 - October 31)
|
$ | 0.19 | $ | 0.06 | $ | 0.07 | $ | 0.03 |
|
·
|
senior
to our common stock; and
|
|
·
|
junior
to all of our existing and future
indebtedness.
|
|
·
|
Continue
to raise funding to recruit patients in our U.S. based Phase II clinical
study of ADXS11-001 in the therapeutic treatment of CIN and our Indian
based Phase II study in late stage cervical
cancer;
|
|
·
|
Continue
to execute our two Phase II clinical studies of ADXS11-001 in the
therapeutic treatment of CIN and late-stage cervical cancer managed by our
clinical partner Numoda;
|
|
·
|
Continue
to work on our grant from the NIH awarded in August 2009 for $210,000 to
develop a single bioengineered Lm vaccine to deliver two different
antigen-adjuvant proteins;
|
|
·
|
Continue
to focus on our collaboration with the GOG to carry out our Phase II
clinical trial of our ADXS11-001 candidate in the treatment of cervical
cancer largely underwritten by the
NCI;
|
|
·
|
Continue
to focus on our collaboration with the CRUK to carry out our Phase II
clinical trial of our ADXS11-001 candidate in the treatment of head and
neck cancer largely underwritten by the
CRUK;
|
|
·
|
Continue
to work with our strategic and development collaborations with academic
laboratories;
|
|
·
|
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 cancer into clinical trials, and initiate that trial
when and if funding is available;
and
|
|
·
|
Continue
the pre-clinical development of other product candidates, as well as
continue research to expand our technology
platform.
|
|
·
|
Cost
incurred to date: approximately $1.1
million
|
|
·
|
Estimated
future clinical costs: $5.7 million to $6.0
million
|
|
·
|
Anticipated
Timing: start February 2010; completion August 2012 or
beyond
|
|
·
|
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.
|
|
·
|
Cost
incurred to date: approximately
$101,650
|
|
·
|
Estimated
future clinical costs: $2.1 million to $2.3
million
|
|
·
|
Anticipated
Timing: start February 2010; completion August 2012 or
beyond
|
|
·
|
One
or more serious adverse events in these late stage cancer patients
enrolled in the trial; and
|
|
·
|
Difficulty
in recruiting patients especially in a new
country.
|
|
·
|
Cost
incurred to date: less than $10,000
|
|
·
|
Estimated
future clinical costs: $500,000 (Government absorbed cost $2.5 million to
$3.0 million)
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Unknown
timing in recruiting patients and conducting the study based on GOG/NCI
controlled study;
|
|
·
|
Delays
in the program; and
|
|
·
|
Given
the economic environment the trial may not get
funded.
|
|
·
|
Cost
incurred to date: less than
$25,000
|
|
·
|
Estimated
future clinical costs: $500,000 (CRUK to absorbed cost $2.5 million to
$3.0 million)
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Unknown
timing in recruiting patients and conducting the study based on CRUK
controlled study;
|
|
·
|
Delays
in the program; and
|
|
·
|
Given
the economic environment the trial may not get
funded.
|
|
·
|
Cost
incurred to date: approximately
$200,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
New
agent; and
|
|
·
|
FDA
(or foreign regulatory authority) may not approve the
study.
|
|
·
|
Cost
incurred to date: $450,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Clinical
trial expenses increased by $866,111, or 304%, to $1,150,880 from $284,769
primarily due to the close out of our Phase I trial in the Fiscal 2008
Period which was offset by the start-up costs of our Phase II cervical
cancer study in India and CIN study in the US both in the Fiscal 2009
Period.
|
|
·
|
Wages,
options and lab costs decreased by $215,180 or 18% to $969,639 from
$1,184,819 principally due to the recording of the full year’s bonus
accrual in Fiscal 2008 that was reversed in Fiscal 2009 Period or
$279,558. No bonus accrual was recorded nor paid in Fiscal 2009 Period.
Overall the lab costs were lower by $80,387 due to the priority given to
the lower cost of grant and publication writing. These lower costs were
partially offset by $120,182 in higher option expense relating to new
grants in Fiscal 2009 Period and $24,583 in wages primarily due to the new
hire of the Executive Director, Product Development in March
2008.
|
|
·
|
Consulting
expenses decreased by $25,195, or 18%, to $114,970 from $140,165,
principally due to higher option expense of $54,903 recorded in Fiscal
2009 Period relating to the true-up of unvested options at higher stock
prices compared to a credit to option expense of $42,307 due to the true
up of unvested option expense recorded in prior fiscal periods at lower
stock prices. This increase of option expense which was offset in part by
the lower effort required to prepare the IND filing for the FDA or $80,098
in the Fiscal 2009 Period compared to the same period last
year.
|
|
·
|
Subcontracted
research expenses decreased by $172,473, or 100%, to $0 from $172,473
reflecting the completion of the project prior to Fiscal 2009 Period
performed by Dr. Paterson at Penn, pursuant to a sponsored research
agreement ongoing in the Fiscal 2008
Period.
|
|
·
|
Manufacturing
expenses decreased by $592,907, to $80,067 from $672,974, or 88% resulting
from the completion of our clinical supply program for the upcoming phase
II trials prior to Fiscal 2009 Period compared to the manufacturing
program in the Fiscal 2008 Period.
|
|
·
|
Toxicology
study expenses decreased by $26,640, to $0 or 100% due the completion in
Fiscal 2008 Period of our toxicology study by Pharm Olam in connection
with our ADXS111-001 product candidates in anticipation of clinical
studies in 2008.
|
|
·
|
Wages,
Options and benefit expenses decreased by $40,953, or 3% to $1,169,227
from $1,210,180 principally due to the reversal of a twelve month bonus
accrual in Fiscal 2009 Period or $89,877 that was recorded as expense in
Fiscal 2008 Period (no bonus accrual was recorded nor paid in Fiscal 2009
Period) and less stock was issued in Fiscal 2009 Period compared to
$43,030 worth of stock was issued primarily to the CEO per his employment
agreement in Fiscal 2008 Period. These lower expenses were
partially offset by higher option expense of $77,949 primarily due to new
stock options granted in Fiscal 2009 Period and $14,005 in overall higher
wages and related fees in the Fiscal 2009 Period than Fiscal 2008
Period.
|
|
·
|
Consulting
fees decreased by $350,136, or 82%, to $77,783 from $427,919. This
decrease was primarily attributed to a one-time payment in settlement of
Mr. Appel’s (our previous President & CEO) employment agreement of
$144,615 recorded in the Fiscal 2008 Period. In addition, consulting
expenses were sharply down by $255,521 due to no financial advisor fees in
Fiscal 2009 Period compared to $256,571 recorded in the Fiscal 2008 Period
attributed to the close of the October 17, 2007 offering. These lower fees
were partially offset by $50,000 fees recorded for the Sage Group
(Business Development Consultants) in Fiscal 2009 Period for seeking
corporate partnerships that didn’t occur in Fiscal 2008
Period.
|
|
·
|
Offering
expenses increased by $396,128 to $449,646 from $53,518. The $396,128
increase in offering expenses recorded in Fiscal 2009 Period consists of
legal costs in preparation for financial raises and SEC filings that
didn’t occur in Fiscal 2008 Period, partially offset by non-cash warrants
expense.
|
|
·
|
Increases
in legal, accounting, professional and public relations expenses of
$77,389, or 14%, to $643,032 from $565,643, primarily as a result of a
higher overall legal, patent expenses and filing fees of $107,870
partially offset by lower public relations and tax preparation fees in
Fiscal 2009 Period than in the Fiscal 2008
Period.
|
|
·
|
Amortization
of intangibles and depreciation of fixed assets decreased by $86,189, or
44%, to $111,156 from $197,345 primarily due to a $91,453 write-off of our
trademarks in the Fiscal 2008 Period partially offset by an increase in
fixed assets and intangibles in the Fiscal 2009 Period compared to the
Fiscal 2008 Period.
|
|
·
|
Analysis
Research cost decreased by $101,949 or 100%, to $0 from $101,949 due to a
one time report and business analysis report in the Fiscal 2008 Period not
repeated in Fiscal 2009 Period.
|
|
·
|
Recruiting
fees for the Executive Director of Product Development in Fiscal 2008
Period was $63,395 and there was no such expense in Fiscal 2009
Period.
|
|
·
|
Overall
occupancy and conference related expenses decreased by $165,442 or 40% to
$250,290 from $415,732. Conference and dues and subscription expenses have
decreased by $145,396 in the Fiscal 2009 Period due to lower participation
in cancer conferences. In addition lower travel related to the reduced
conferences attendance, taxes and other miscellaneous expenses amounted to
a decrease of $20,046 in the Fiscal 2009 Period than incurred in Fiscal
2008 Period.
|
|
·
|
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.
|
Product
|
Indication
|
Stage
|
||
ADXS11-001
|
Cervical
Cancer
|
Phase I Company
sponsored & completed in 2007.
|
||
Cervical
Intraepithelial Neoplasia
|
Phase II Company
sponsored study anticipated to commence in early 2010.
|
|||
Cervical
Cancer
|
Phase II Company
sponsored study anticipated to commence in early 2010 in India. 110
Patients with advanced cervical cancer.
|
|||
Cervical
Cancer
|
Phase II The Gynecologic
Oncology Group of the National Cancer Institute may conduct a study
(timing to be determined).
|
|||
Head
& Neck Cancer
|
Phase I The Cancer
Research UK (CRUK) is conducting a study of up to 45 patients (timing to
be determined).
|
|||
ADXS31-142
|
Prostate
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
Breast
Cancer
|
Phase I Company
sponsored (timing to be
determined).
|
|
1.
|
Very
strong innate immune response
|
|
2.
|
Stimulates
inordinately strong killer Tregs
response
|
|
3.
|
Stimulates
helper Tregs
|
|
4.
|
Stimulates
release of and/or up-regulates immuno-stimulatory cytokines, chemokines,
co-stimulatory molecules
|
|
5.
|
Adjuvant
activity creates a local tumor environment that supports anti-tumor
efficacy
|
|
6.
|
Minimizes
inhibitory Tregs and inhibitory cytokines and shifts to Th-17
pathway
|
|
7.
|
Stimulates
the development and maturation of all Antigen Presenting Cells and
effector Tregs & reduces immature myeloid
cells
|
|
8.
|
Eliminates
sources of endogenous inhibition present within tumors that suppress
activated immune cells and prevent them from working within
tumors
|
|
9.
|
Effecting
non-immune systems that support the immune response, like the vascular
system, the marrow, and the maturation of cells in the blood
stream
|
|
10.
|
Enables
epitope spreading to increase the number of antigens attacked by the
immune system.
|
|
·
|
Who
must be recruited as qualified participants and who is to be
excluded;
|
|
·
|
how
often, and how to administer the drug and at what
dose(s);
|
|
·
|
what
tests to perform on the participants;
and
|
|
·
|
what
evaluations are to be made and how the data will be
assessed.
|
Name
|
Age
|
Position
|
||
Thomas
A. Moore
|
59
|
Chief
Executive Officer and Chairman of our Board of
Directors
|
||
Dr.
James Patton
|
51
|
Director
|
||
Roni
A. Appel
|
42
|
Director
|
||
Dr.
Thomas McKearn
|
60
|
Director
|
||
Richard
Berman
|
67
|
Director
|
||
John
Rothman, Ph.D.
|
61
|
Executive
Vice President of Clinical and Scientific Operations
|
||
Mark
J. Rosenblum
|
56
|
Chief
Financial Officer, Senior Vice President and
Secretary
|
|
·
|
reviewing
the results of the audit engagement with the independent registered public
accounting firm;
|
|
·
|
identifying
irregularities in the management of our business in consultation with our
independent accountants, and suggesting an appropriate course of
action;
|
|
·
|
reviewing
the adequacy, scope, and results of the internal accounting controls and
procedures;
|
|
·
|
reviewing
the degree of independence of the auditors, as well as the nature and
scope of our relationship with our independent registered public
accounting firm;
|
|
·
|
reviewing
the auditors’ fees; and
|
|
·
|
recommending
the engagement of auditors to the full board of
directors.
|
|
·
|
identifying
and recommending to the board of directors individuals qualified to serve
as members of our board of directors and on the committees of the
board;
|
|
·
|
advising
the board with respect to matters of board composition, procedures and
committees;
|
|
·
|
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally
including review of possible conflicts and transactions with persons
affiliated with directors or members of management;
and
|
|
·
|
overseeing
the annual evaluation of the board and our
management.
|
Name and
Principal
Position
|
Fiscal Year
|
Salary
|
Bonus
|
Stock
Award(s)
(1)
|
Option
Award(s)
(1)
|
All Other
Compensation
|
Total
|
|||||||||||||||||||
Thomas A.
Moore,
|
2009
|
$ | 350,000 | $ | — | $ | 71,250 | (2) | $ | 115,089 | $ | 17,582 | (3) | $ | 553,919 | |||||||||||
CEO
and Chairman
|
2008
|
352,692 | — | — | 156,364 | 27,626 | (4) | 536.682 | ||||||||||||||||||
Dr.
John Rothman,
|
2009
|
250,000 | — | 11,550 | (5) | 82,911 | 23,797 | (6) | 368,258 | |||||||||||||||||
Executive
VP of Science
& Operations
|
2008
|
255,000 | 55,000 | 23,378 | (5) | 25,092 | 27,862 | (6) | 386,332 | |||||||||||||||||
Fredrick
D. Cobb,
|
2009
|
180,000 | — | 29,167 | (7) | 55,117 | 7,685 | (6) | 271,968 | |||||||||||||||||
VP
Finance
|
2008
|
182,923 | 40,000 | 15,585 | (8) | 19,977 | 7,136 | (6) | 265,621 |
(1)
|
The
amounts shown in this column represent the compensation expense incurred
by us for the fiscal year in accordance with FAS 123(R) using the
assumptions described under “ Share-Based Compensation
Expense ” in Note 2 to our financial statements included elsewhere
in this prospectus.
|
(2)
|
Represents
750,000 shares of our common stock granted to Mr. Moore based on the
financial raise milestone in his employment agreement valued at the market
close price on April 4, 2008.
|
(3)
|
Based
on our cost of Mr. Moore’s coverage for health
care.
|
(4)
|
Based
on our cost of Mr. Moore’s coverage for health care and interest received
for the Moore Notes.
|
(5)
|
Represents:
(i) $30,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 150,000 shares earned, but not issued, in 2009 and 196,339 shares
earned, but not issued, in 2008.
|
(6)
|
Based
on our cost of his coverage for health care and the 401K company match he
received.
|
(7)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the daily average closing stock price per month
retrospectively to January 1, 2008, and (ii) the compensation expense
incurred in connection with 704,342 shares earned, but not
issued.
|
(8)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 130,893 shares earned, but not
issued.
|
Option Awards
|
Stock Awards
|
||||||||||||||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Equity
Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)
|
Market Value
of Shares or
Units of Stock
That Have
Not Vested ($)
|
Equity Incentive
Plan Awards:
Number of
Unearned
Shares, Units or
Other Rights
That Have Not
Vested (#)
|
Equity Incentive
Plan
Awards: Market
or
Payout Value of
Unearned Shares,
Units or Other
Rights
That Have Not
Vested ($)
|
||||||||||||||||||||
Thomas
A. Moore
|
833,333
|
1,666,667
|
(1)
|
—
|
0.100
|
7/21/19
|
—
|
$
|
—
|
—
|
—
|
||||||||||||||||||
2,400,000
|
—
|
—
|
0.143
|
12/15/16
|
750,000
|
(2)
|
97,500
|
(3)
|
—
|
—
|
|||||||||||||||||||
Dr.
John Rothman
|
583,333
|
1,166,667
|
(4)
|
—
|
0.100
|
7/21/19
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
360,000
|
—
|
—
|
0.287
|
3/1/15
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
131,250
|
18,750
|
(5)
|
—
|
0.260
|
3/29/16
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
187,500
|
131,250
|
(6)
|
—
|
0.165
|
2/15/17
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Fredrick
D. Cobb
|
333,333
|
666,667
|
(7)
|
—
|
0.100
|
7/21/19
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
131,250
|
18,750
|
(8)
|
—
|
0.260
|
2/20/16
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
112,500
|
37,500
|
(9)
|
—
|
0.160
|
9/21/16
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
93,750
|
56,250
|
(10)
|
—
|
0.165
|
2/15/17
|
—
|
—
|
—
|
—
|
(1)
|
Of
these options, approximately 833,333 will become exercisable on each
anniversary date of July 21, 2010 and
2011.
|
(2)
|
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
issued on April 4, 2008 upon our successful raise of $4.0 million and
750,000 shares are issuable upon our successful raise of an additional
$6.0 million.
|
(3)
|
Based
on the closing sale price of $0.13 per share of common stock on October
31, 2009 (the last day of our fiscal
year).
|
(4)
|
Of
these options, approximately 583,333 will become exercisable on each
anniversary date of July 21, 2010 and
2011.
|
(5)
|
Of
these options, 9,375 became exercisable on December 29, 2009 and 9,375
will become exercisable on March 29,
2010.
|
(6)
|
Of
these options, 18,750 became exercisable on November 15, 2009, and 18,750
will become exercisable on each of February 15, May 15, August 15 and
November 15 of each year until February 15,
2011.
|
(7)
|
Of
these options, approximately 333,333 will become exercisable on each
anniversary date of July 21, 2010 and
2011.
|
(8)
|
Of
these options, 9,375 became exercisable on November 20, 2009 and 9,375
will become exercisable on February 20,
2010.
|
(9)
|
Of
these options, 9,375 became exercisable on December 21, 2009 and 9,375
will become exercisable on each of March 21, 2010, June 21, 2010 and
September 21, 2010.
|
(10)
|
Of
these options, 9,375 became exercisable on November 15, 2009 and 9,375
will become exercisable on each of February 15, May 15, August 15 and
November 15 of each year until February 15,
2011.
|
Name
|
Fees
Earned
or Paid
in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)(1)
|
All other
Compensation
($)
|
Total
($)
|
|||||||||||||||
Roni
A. Appel
|
$ | 7,500 | $ | 1,848 | (2 | ) | $ | 12,464 | (3 | ) | — | $ | 21,812 | |||||||
Dr.
James Patton
|
11,250 | 1,848 | (2 | ) | 12,464 | (3 | ) | — | 25,562 | |||||||||||
Dr.
Thomas McKearn
|
10,500 | 1,848 | (2 | ) | 23,518 | (4 | ) | — | 35,866 | |||||||||||
Richard
Berman
|
3,750 | 31,840 | (5 | ) | 21,972 | (6 | ) | — | 57,563 |
(1)
|
The
amounts shown in this column represents the compensation expense incurred
by us for the fiscal year in accordance with FAS 123(R) using
the assumptions described under “Share –Based Compensation Expense” in
Note 2 to our financial statements included elsewhere in this
prospectus.
|
(2)
|
Based
on the board of directors’ compensation plan subject to approval by
stockholders paying 6,000 shares a quarter if the member attends at least
75% of the meetings annually.
|
(3)
|
Based
on the vesting of 350,000 options of our common stock granted on July 21,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant
date.
|
(4)
|
Based
on the vesting of 500,000 options of our common stock granted on July 21,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant date. Based on
the vesting of 150,000 options of our common stock granted on March 29,
2006 at a market price of $0.261 share. Vests quarterly over a
three year period at a fair value of $0.1434 share value Black Scholes
Model at grant date.
|
(5)
|
Based
on the average monthly closing prices of our common stock for the $2,000
monthly compensation. The total shares earned but not issued in fiscal
year 2009 was 325,765.
|
(6)
|
Based
on the vesting of 500,000 options of our common stock granted on July 23,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant
date. Based on the vesting of 400,000 options of our common
stock granted at $0.287 per share on February 1, 2005. These
options vested quarterly over the next four
years.
|
|
·
|
each
person who is known by us to be the beneficial owner of more than 5% of
our outstanding common stock;
|
|
·
|
each
of our directors;
|
|
·
|
each
of our named executive officers;
and
|
|
·
|
all
of our directors and executive officers as a
group.
|
Name and Address
of Beneficial Owner
|
Number of
Shares of
our
Common Stock
Beneficially Owned
|
Percentage
of Class
Beneficially Owned
|
||||||
Optimus
CG II, Ltd.
|
12,592,923
|
(1)
|
9.0
|
%
|
||||
Thomas
A. Moore
|
7,409,034
|
(2)
|
5.6
|
%
|
||||
Roni
A. Appel
|
6,655,891
|
(3)
|
5.1
|
%
|
||||
Richard
Berman
|
1,653,056
|
(4)
|
1.3
|
%
|
||||
Dr.
James Patton
|
3,082,496
|
(5)
|
2.4
|
%
|
||||
Dr.
Thomas McKearn
|
650,720
|
(6)
|
*
|
|||||
Dr.
John Rothman
|
2,712,585
|
(7)
|
2.1
|
%
|
||||
Fredrick
Cobb**
|
1,569,320
|
(8)
|
1.2
|
%
|
||||
All
Directors and Executive Officers as a Group (8 people)
|
24,066,435
|
(9)
|
17.2
|
%
|
(1)
|
Represents
approximately 9.9% of our outstanding shares of common stock as of January
27, 2010 that may be acquired by the holder under a warrant exercisable
for up to 22,187,000 shares of common stock within 60 days of January 27,
2010. Such warrant is not fully exercisable within 60 days
thereof due to contractual limitations and a 9.9% ownership limitation
contained in the warrant for the holder and its affiliates. The
sole stockholder of the holder is Optimus Capital Partners, LLC, d/b/a
Optimus Life Sciences Capital Partners, LLC. Voting and
dispositive power with respect to these securities is exercised by Terry
Peizer, the Managing Director of Optimus Life Sciences Capital Partners,
LLC, who acts as investment advisor to the holder. The holder is not a
registered broker-dealer or an affiliate of a registered
broker-dealer. The address of the principal business office of
the holder is Cricket Square, Hutchins Drive, Grand Cayman, KY1-1111
Cayman Islands and the address of the principal business office of Optimus
Life Sciences Capital Partners, LLC is 11150 Santa Monica Boulevard, Suite
1500, Los Angeles, CA 90025.
|
(2)
|
Represents
3,425,700 issued shares of our common stock and options to purchase
3,233,334 shares of our common stock exercisable within 60
days. In addition, Mr. Moore owns warrants to purchase
4,889,760 shares of our common stock, limited by a 4.99% beneficial
ownership provision in the warrants that would prohibit him from
exercising any of such warrants to the extent that upon such exercise he,
together with his affiliates, would beneficially own more than 4.99% of
the total number of shares of our common stock then issued and outstanding
(unless Mr. Moore provides us with 61 days' notice of the holders waiver
of such provisions). In addition, Mr. Moore beneficially owns 750,000
shares of our common stock earned, but not
issued.
|
(3)
|
Represents
4,130,134 issued shares of our common stock, options to purchase 2,495,757
shares of our common stock exercisable within 60 days and 30,000 shares of
our common stock earned but not yet
issued.
|
(4)
|
Represents
760,624 issued shares of our common stock, options to purchase 566,667
shares of our common stock exercisable within 60 days and 325,765 shares
of our common stock earned but not yet
issued.
|
(5)
|
Represents
2,820,576 issued shares of our common stock, options to purchase 189,920
shares of our common stock exercisable within 60 days and 72,000 shares
earned but not yet issued.
|
(6)
|
Represents
179,290 issued shares of our common stock, options to purchase 399,430
shares of our common stock exercisable within 60 days and 72,000 shares of
our common stock earned but not yet
issued.
|
(7)
|
Represents
275,775 issued shares of our common stock, options to purchase 1,308,958
shares of our common stock exercisable within 60 days and 1,127,852 shares
of our common stock earned but not yet
issued.
|
(8)
|
Represents
90,336 issued shares of our common stock, options to purchase 727,083
shares of our common stock exercisable within 60 days and
751,901 shares of our common stock earned but not yet
issued.
|
(9)
|
Represents
an aggregate of 11,682,435 issued shares of our common stock, options to
purchase 9,254,482 shares of our common stock exercisable within 60 days,
and 3,129,518 shares of our common stock earned but not yet
issued.
|
Selling
Stockholder
|
Shares Beneficially
Owned Before
Offering (1)
|
Shares Being
Offered
(2)
|
Shares to be Beneficially
Owned After
Offering
|
Percentage to be
Beneficially
Owned After
Offering
|
||||||||||||
2056850
Ontario Inc.
|
588,236 | 588,236 | - | - | ||||||||||||
Alpha
Capital Austalt
|
1,470,589 | 1,470,589 | - | - | ||||||||||||
Andrew
Latos
|
323,530 | 323,530 | - | - | ||||||||||||
Anthony
G. Polak
|
147,060 | 147,060 | - | - | ||||||||||||
Anthony
G. Polak "s"
|
147,060 | 147,060 | - | - | ||||||||||||
Ariel
Shatz and Talya Miron-Shatz
|
628,582 | 294,119 | 334,463 | * | ||||||||||||
Arthur
& Christine Handal
|
147,060 | 147,060 | - | - | ||||||||||||
Bridge
Ventures, Inc.(3)
|
177,150 | 176,472 | 678 | * | ||||||||||||
Brio
Capital LP
|
1,885,742 | 882,354 | 1,003,388 | * | ||||||||||||
CAMHZN
Master LDC(4)
|
2,352,942 | 2,352,942 | - | - | ||||||||||||
CAMOFI
Master LDC(5)
|
9,411,766 | 9,411,766 | - | - | ||||||||||||
Carter
Management Group LLC(6)
|
441,177 | 441,177 | ||||||||||||||
Cary
Fields
|
1,323,530 | 1,323,530 | - | - | ||||||||||||
Castlerigg
Master Investments, Ltd.
|
5,852,942 | 5,852,942 | - | - | ||||||||||||
Chestnut
Ridge Partners LP
|
3,529,413 | 3,529,413 | - | - | ||||||||||||
Christopher
Kyriakides
|
891,177 | 891,177 | - | - | ||||||||||||
David
Ismailer
|
628,582 | 294,119 | 334,463 | * | ||||||||||||
Emilio
DiSanluciano
|
294,119 | 294,119 | - | - | ||||||||||||
Endeavor
Asset Management, L.P.
|
590,495 | 588,236 | 2,253 | * | ||||||||||||
Flavio
Sportelli
|
282,863 | 132,354 | 150,509 | * | ||||||||||||
Gerald
A Brauser TTEE FBO Bernice Brauser Irrevocable Trust
|
882,354 | 882,354 | * | |||||||||||||
Gerald
Cohen
|
377,150 | 176,472 | 200,678 | * | ||||||||||||
Gregory
William Eagan
|
377,150 | 176,472 | 200,678 | * | ||||||||||||
Isaac
Cohen
|
58,825 | 58,825 | - | - | ||||||||||||
Jack
Erlanger
|
147,060 | 147,060 | - | - | ||||||||||||
James
F. Spallino TTEE FBO Spallino Family Trust
|
314,292 | 147,060 | 167,232 | * | ||||||||||||
John
G. Golfinos
|
1,257,162 | 588,236 | 668,926 | * | ||||||||||||
John
Lilly Strategic Insight, LLC(7)
|
2,793,313 | 882,354 | 1,910,959 | 1.5 | % | |||||||||||
Joseph
Giamanco
|
441,177 | 441,177 | - | - | ||||||||||||
Julie
Arkin
|
294,119 | 294,119 | - | - | ||||||||||||
Keith
M Rosenbloom
|
314,292 | 147,060 | 167,232 | * | ||||||||||||
Leonard
Cohen
|
377,150 | 176,472 | 200,678 | * | ||||||||||||
Lipman
Capital Group Inc. Retirement Plan(6)
|
341,012 | 339,707 | 1,305 | * | ||||||||||||
Mary
Tagliaferri
|
58,825 | 58,825 | - | - | ||||||||||||
Michael
H. Freedman
|
147,060 | 147,060 | - | - | ||||||||||||
Michael
Miller
|
441,177 | 441,177 | - | - | ||||||||||||
Michael
Sobeck
|
73,530 | 73,530 | - | - | ||||||||||||
Micro
Capital Fund LP
|
1,328,611 | 1,323,530 | 5,081 | * | ||||||||||||
Micro
Capital Fund Ltd.
|
441,177 | 441,177 | - | - | ||||||||||||
Lawrence
Kaplan
|
441,177 | 441,177 | - | - | ||||||||||||
Optimus
CG II, Ltd. (8)
|
22,187,000 | 22,187,000 | - | - | ||||||||||||
Othon
Mourkakos
|
882,354 | 882,354 | - | - | ||||||||||||
Pan
Brothers Capital Management Group LLC
|
628,582 | 294,119 | 334,463 | * | ||||||||||||
Pershing
LLC Custodian FBO Ronald M. Lazar
|
88,236 | 88,236 | - | - | ||||||||||||
Peter
Latos
|
470,859 | 470,859 | - | - | ||||||||||||
Peter
Malo
|
294,119 | 294,119 | - | - | ||||||||||||
Philip
A. DiPippo
|
295,249 | 294,119 | 1,130 | * | ||||||||||||
Philip
Patt & Maxine Patt JTWROS
|
1,029,413 | 1,029,413 | - | - | ||||||||||||
Phylis
Meier
|
628,582 | 294,119 | 334,463 | * | ||||||||||||
Platinum
Long Term Growth VII
|
5,882,354 | 5,882,354 | - | - | ||||||||||||
Revach
|
294,119 | 294,119 | - | - | ||||||||||||
RL
Capital Partners(9)
|
147,060 | 147,060 | - | - | ||||||||||||
Robert
& Donna Goode
|
88,236 | 88,236 | - | - | ||||||||||||
Robert
Allen Papiri
|
803,772 | 323,530 | 480,242 | * | ||||||||||||
Robert
Henry Cohen(10)
|
6,487,501 | 2,941,177 | 3,546,324 | 2.7 | % | |||||||||||
Steven
B. Gold(11)
|
799,439 | 294,119 | 505,320 | * | ||||||||||||
Steven
J. Shankman
|
354,297 | 352,942 | 1,355 | * | ||||||||||||
Suzanne
Henry
|
628,582 | 294,119 | 334,463 | * | ||||||||||||
Thomas
A. Moore(12)
|
11,548,795 | 2,352,942 | 9,195,853 | 5.1 | % | |||||||||||
Whalehaven
Capital Fund Limited
|
1,470,589 | 1,470,589 | - | - | ||||||||||||
Zenith
Capital Corporation Money Purchase Pension Plan
|
441,177 | 441,177 | - | - |
(1)
|
Except
as otherwise indicated in the footnotes to this table, the number and
percentage of shares beneficially owned is determined in accordance with
Rule 13d-3 of the Exchange Act, and the information is not necessarily
indicative of beneficial ownership for any other purpose. Under such rule,
beneficial ownership includes any shares as to which the selling
stockholder has sole or shared voting power or investment power and also
any shares, which the selling stockholder has the right to acquire within
60 days.
|
(2)
|
Except
as otherwise described herein, shares being offered consists of shares of
our common stock underlying warrants issued in connection with our 2007
private placement (including additional shares of common stock issuable
upon those warrants as a result of certain anti dilution protection
provisions contained therein).
|
(3)
|
Pursuant
to a consulting agreement between us and Bridge Ventures dated as of March
15, 2007, as amended on October 17, 2007, we granted Bridge Ventures
five-year warrants to purchase 800,000 shares of our common stock at $0.20
per share (prior to anti-dilution adjustments) and agreed to pay Bridge
Ventures an initial fee of $60,000 and a monthly fee of $5,000 for six
months, unless extended. The agreement secured the consults services in
overall strategic planning, business opportunities and related
services.
|
(4)
|
CAMHZN
holds warrants to purchase 2,352,942 shares of our common stock limited by
a 4.99% beneficial ownership provision that would prohibit CAMHZN from
exercising any of such warrants to the extent that upon such exercise,
CAMHZN, together with its affiliates, would beneficially own more than
4.99% of the total number of shares of our common stock then issued and
outstanding, unless it provides us with 61 days’ notice of its waiver of
such provisions. CAMHZN is an affiliate of CAMOFI and each of them are
affiliates of Centrecourt. Centrecourt disclaims beneficial ownership of
all of our securities.
|
(5)
|
CAMOFI
holds warrants to purchase 9,411,766 shares of our common stock limited by
a 4.99% beneficial ownership provision that would prohibit CAMOFI from
exercising any of such warrants to the extent that upon such exercise,
CAMOFI, together with its affiliates, would beneficially own more than
4.99% of the total number of shares of our common stock then issued and
outstanding, unless it provides us with 61 days’ notice of its waiver of
such provisions. CAMOFI is an affiliate of CAMHZN and each of them are
affiliates of our financial advisor,
Centrecourt.
|
(6)
|
John
C. Lipman is the managing and sole member of Carter Management Group LLC
and the owner of Lipman Capital Group, Inc. Retirement
Plan. Mr. Lipman is also the sole owner of Carter Securities
LLC, the placement agent in connection with our October 2007 private
placement. Pursuant to the related placement agency agreement,
Carter Securities, LLC received $354,439 in cash commissions,
reimbursement of expenses and warrants to purchase 2,949,333 shares of our
common stock with an exercise price of $0.20 per share (prior to
anti-dilution adjustments). These warrants are not included in
the number displayed. Each of these entities has advised us that (i) it
acquired the common stock and warrants in the ordinary course of business
and (ii) at the time of the purchase of the common stock and warrants to
be resold, it did not have any agreement or understanding, directly or
indirectly, to distribute the shares of common stock and warrants offered
hereunder. Mr. Lipman is presently a managing director of
EarlyBirdCapital, Inc., a FINRA
member.
|
(7)
|
In
connection with a bridge loan bearing interest at 12%, Mr. Lilly received
five-year warrants to purchase 37,500 shares of our common stock at $0.287
per share (prior to anti-dilution
adjustments).
|
(8)
|
Optimus
CG II, Ltd. holds warrants to purchase 22,187,000 shares of our common
stock. However, the warrant is not fully exercisable within 60
days due to contractual limitations and a 9.9% ownership limitation
contained in the warrant for the holder and its affiliates. The
sole stockholder of the holder is Optimus Capital Partners, LLC, d/b/a
Optimus Life Sciences Capital Partners, LLC. Voting and dispositive power
with respect to these securities is exercised by Terry Peizer, the
Managing Director of Optimus Life Sciences Capital Partners, LLC, who acts
as investment advisor to the holder. The holder is not a registered
broker-dealer or an affiliate of a registered
broker-dealer.
|
(9)
|
Ronald
Lazar and Anthony Polak are the Managing Members of RL Capital Management,
LLC, the General Partner of RL Capital
Partners.
|
(10)
|
Includes
warrants to purchase 2,941,177 shares of our common stock, which are
limited by a 4.99% beneficial ownership provision in the warrants that
would prohibit Mr. Cohen from exercising any of such warrants to the
extent that upon such exercise he, together with his affiliates, would
beneficially own more than 4.99% of the total number of shares of our
common stock then issued and outstanding (unless Mr. Cohen provides us
with 61 days' notice of the holders waiver of such
provisions).
|
(11)
|
In
connection with a bridge loan bearing interest at 12%, Mr. Gold received
five-year warrants to purchase 12,500 shares of our common stock at $0.287
per share (prior to anti-dilution
adjustments).
|
(12)
|
Shares
held by MLPF&S CUST FBO Thomas A. Moore are for the benefit of Mr.
Moore, our chief executive officer and Chairman of the board of directors.
This number represents 3,425,700 shares of our common stock, options to
purchase 3,233,334 shares of our common stock exercisable within 60 days,
and warrants to purchase 4,889,760 shares of our common stock, which are
limited by a 4.99% beneficial ownership provision in the warrants that
would prohibit him from exercising any of such warrants to the extent that
upon such exercise he, together with his affiliates, would beneficially
own more than 4.99% of the total number of shares of our common stock then
issued and outstanding (unless Mr. Moore provides us with 61 days' notice
of the holders waiver of such
provisions).
|
|
·
|
senior
to our common stock and any other class or series of preferred stock
(other than a 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); 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.
|
|
·
|
our
common stock must be listed for trading or quoted on the OTC Bulletin
Board (or another eligible trading market), and we must be in compliance
with all reporting requirements under the Securities Exchange Act of 1934,
as amended, in order to maintain such
listing;
|
|
·
|
either
(i) we have a current, valid and effective registration statement covering
the resale of all shares underlying the warrant or (ii) all shares
underlying the warrant are eligible for resale without limitation under
Rule 144 (assuming cashless exercise of the
warrant);
|
|
·
|
there
must not be any material adverse effect with respect to the company since
the date we executed the purchase agreement, other than losses incurred in
the ordinary course of business;
|
|
·
|
we
must not be in default under any material
agreement;
|
|
·
|
ten
trading day lock-up agreements, subject to certain extensions, with our
senior officers and directors and certain beneficial owners of 10% or more
of our outstanding common stock must be
effective;
|
|
·
|
there
must not be any legal restraint prohibiting the transactions contemplated
by the purchase agreement; and
|
|
·
|
the
aggregate of all shares of our common stock beneficially owned by Optimus
and its affiliates must not exceed 9.99% of our outstanding common
stock.
|
|
·
|
1%
of the number of shares of our common stock then outstanding, which
equaled 1,272,012 shares as of January 27, 2010,
or
|
|
·
|
the
average weekly trading volume of our common stock on the OTC Bulletin
Board during the four calendar weeks preceding the filing of a notice on
Form 144 with respect to that sale.
|
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
|
·
|
broker-dealers
may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per
share;
|
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
|
·
|
a
combination of any such methods of sale;
or
|
|
·
|
any
other method permitted pursuant to applicable
law.
|
Page
|
|
Audited
Financial Statements
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Balance
Sheets as of October 31, 2009 and 2008
|
F-3
|
Statements
of Operations for the years ended October 31, 2009 and 2008 and the period
from March 1, 2002 (Inception) to October 31, 2009
|
F-4
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to October 31, 2009
|
F-5
|
Statements
of Cash Flows for the years ended October 31, 2009 and 2008 and the period
from March 1, 2002 (Inception) to October 31, 2009
|
F-6
|
Notes
to Financial Statements
|
F-8
|
October 31,
2009
|
October 31,
2008
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 659,822 | $ | 59,738 | ||||
Prepaid
expenses
|
36,445 | 38,862 | ||||||
Total
Current Assets
|
696,267 | 98,600 | ||||||
Deferred
expenses
|
288,544 | — | ||||||
Property
and Equipment (net of accumulated depreciation)
|
54,499 | 91,147 | ||||||
Intangible
Assets (net of accumulated amortization)
|
1,371,638 | 1,137,397 | ||||||
Deferred
Financing Cost
|
299,493 | |||||||
Other
Assets
|
3,876 | 3,876 | ||||||
TOTAL
ASSETS
|
$ | 2,714,317 | $ | 1,331,020 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 2,368,716 | $ | 998,856 | ||||
Accrued
expenses
|
917,250 | 603,345 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
2,078,851 | — | ||||||
Notes
payable – current portion, including interest payable
|
1,121,094 | 563,317 | ||||||
Total
Current Liabilities
|
6,485,911 | 2,165,518 | ||||||
Common
Stock Warrant
|
11,961,734 | — | ||||||
Notes
payable - net of current portion
|
— | 4,813 | ||||||
Total
Liabilities
|
$ | 18,447,645 | $ | 2,170,331 | ||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and
outstanding
|
— | — | ||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 115,638,243 in 2009 and 109,319,520 in 2008
|
115,638 | 109,319 | ||||||
Additional
Paid-In Capital
|
754,834 | 16,584,414 | ||||||
Deficit
accumulated during the development stage
|
(16,603,800 | ) | (17,533,044 | ) | ||||
Total
Shareholders' Deficiency
|
(15,733,328 | ) | (839,311 | ) | ||||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$ | 2,714,317 | $ | 1,331,020 |
Year Ended
October 31,
|
Year Ended
October 31,
|
Period from
March 1, 2002
(Inception) to
October 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Revenue
|
$ | 29,690 | $ | 65,736 | $ | 1,354,862 | ||||||
Research
& Development Expenses
|
2,315,557 | 2,481,840 | 10,173,541 | |||||||||
General
& Administrative Expenses
|
2,701,133 | 3,035,680 | 12,709,700 | |||||||||
Total
Operating expenses
|
5,016,690 | 5,517,520 | 22,883,243 | |||||||||
Loss
from Operations
|
(4,987,000 | ) | (5,451,784 | ) | (21,528,379 | ) | ||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(851,008 | ) | (11,263 | ) | (1,935,491 | ) | ||||||
Other
Income
|
46,629 | 246,457 | ||||||||||
Gain
on note retirement
|
— | — | 1,532,477 | |||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
5,845,229 | — | 4,202,997 | |||||||||
Net
Income/( Loss) before income tax benefit
|
7,221 | (5,416,418 | ) | (17,481,939 | ) | |||||||
Income
Tax Benefit
|
922,023 | — | 922,023 | |||||||||
Net
Income/( Loss)
|
929,244 | (5,416,418 | ) | (16,559,916 | ) | |||||||
Dividends
attributable to preferred shares
|
— | — | 43,884 | |||||||||
Net
Income/( Loss) applicable to Common Stock
|
$ | 929,244 | $ | (5,416,418 | ) | $ | (16,603,800 | ) | ||||
Net
Income/(Loss) per share, basic
|
$ | 0.01 | $ | (0.05 | ) | |||||||
Net
Income/(Loss) per share, diluted
|
$ | 0.01 | (0.05 | ) | ||||||||
Weighted
average number of shares outstanding, basic
|
113,365,584 | 108,715,875 | ||||||||||
Weighted
average number of shares outstanding, diluted
|
118,264,246 | 108,715,875 |
Preferred Stock
|
Common Stock
|
Deficit
|
||||||||||||||||||||||||||
Number of
Shares of
Outstanding
|
Amount
|
Number of shares
of outstanding
|
Amount
|
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
|
)
|
|
Period from
|
|||||||||||
March 1
|
||||||||||||
2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
Income (Loss)
|
$
|
929,244
|
$
|
(5,416,418
|
)
|
$
|
(16,559,916
|
)
|
||||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
|
|||||||||||
Non-cash
charges to consultants and employees for options and stock
|
571,525
|
355,364
|
2,424,755
|
|||||||||
Amortization
of deferred financing costs
|
—
|
—
|
260,000
|
|||||||||
Amortization of deferred expenses | 61,456 |
—
|
61,456 | |||||||||
Amortization
of discount on Bridge Loans
|
123,846
|
123,846
|
|
|||||||||
Non-cash
interest expense
|
698,650
|
7,907
|
1,216,835
|
|||||||||
(Gain)
Loss on change in value of warrants and embedded
derivative
|
(5,845,229
|
)
|
—
|
(4,202,997
|
) | |||||||
Value
of penalty shares issued
|
—
|
31,778
|
149,276
|
|||||||||
Depreciation
expense
|
36,648
|
36,137
|
128,738
|
|||||||||
Amortization
expense of intangibles
|
74,508
|
161,208
|
388,019
|
|||||||||
Gain
on note retirement
|
—
|
—
|
(1,532,477
|
)
|
||||||||
(Increase)
decrease in prepaid expenses
|
2,417
|
161,055
|
(36,445
|
)
|
||||||||
Decrease
(increase) in other assets
|
—
|
—
|
(3,876
|
)
|
||||||||
Increase
in accounts payable
|
1,421,838
|
211,559
|
2,857,900
|
|||||||||
(Decrease)
increase in accrued expenses
|
(109,540
|
)
|
298,322
|
477,618
|
||||||||
(Decrease)
increase in interest payable
|
—
|
—
|
18,291
|
|||||||||
Net
cash used in operating activities
|
(2,034,636
|
)
|
(4,153,088
|
)
|
(14,228,977
|
)
|
||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
—
|
—
|
(44,940
|
)
|
||||||||
Purchase
of property and equipment
|
—
|
(10,842
|
)
|
(137,657
|
)
|
|||||||
Cost
of intangible assets
|
(308,749
|
)
|
(200,470
|
)
|
(1,834,609
|
)
|
||||||
Net
cash used in Investing Activities
|
(308,749
|
)
|
(211,312
|
)
|
(2,017,206
|
)
|
||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from (repayment of) convertible secured debenture
|
—
|
—
|
960,000
|
|||||||||
Cash
paid for deferred financing costs
|
(299,493
|
)
|
—
|
(559,493
|
)
|
|||||||
Proceeds
from notes payable
|
3,259,635
|
475,000
|
5,005,860
|
|||||||||
Payment
on notes payable
|
(16,672
|
)
|
(14,832
|
)
|
(123,591
|
)
|
||||||
Net
proceeds of issuance of Preferred Stock
|
—
|
—
|
235,000
|
|||||||||
Payment
on cancellation of Warrants
|
—
|
—
|
(600,000
|
)
|
||||||||
Net
proceeds of issuance of Common Stock
|
—
|
(78,014
|
)
|
11,988,230
|
||||||||
Net
cash provided by Financing Activities
|
2,943,469
|
382,154
|
16,906,005
|
|||||||||
Net
increase in cash
|
600,084
|
(3,982,246
|
)
|
659,822
|
||||||||
Cash
at beginning of period
|
59,738
|
4,041,984
|
—
|
|||||||||
Cash
at end of period
|
$
|
659,822
|
$
|
59,738
|
$
|
659,822
|
Period from
|
||||||||||||
March 1, 2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2009
|
2008
|
2008
|
||||||||||
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 accrued interest converted to Common
Stock
|
$
|
$
|
—
|
$
|
2,513,158
|
|||||||
Intangible
assets acquired with notes payable
|
$
|
$
|
—
|
$
|
360,000
|
|||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$
|
1,579,646
|
$
|
—
|
$
|
2,082,442
|
||||||
Allocation
of the original secured convertible debentures to warrants
|
$
|
$
|
—
|
$
|
214,950
|
|||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$
|
940,511
|
—
|
$
|
940,511
|
|||||||
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
|
1.
|
PRINCIPAL BUSINESS ACTIVITY AND
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES:
|
October 31, 2009
|
October 31, 2008
|
|||||||
Warrants
|
127,456,301 | 97,187,400 | ||||||
Stock
Options
|
7,881,591 | 8,812,841 | ||||||
Convertible Debt (using the if-converted method) | 49,749,280 | — | ||||||
Total
|
185,087,172 | 106,000,241 |
March 1, 2002
(date of
inception) to
October 31,
2009
|
||||
Net
Loss as reported
|
$
|
(16,559,916
|
)
|
|
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
|
$
|
(16,798,875
|
)
|
Year Ended
|
Year Ended
|
|||||||
October 31,
2009
|
October 31,
2008
|
|||||||
Expected
volatility
|
170.2
|
%
|
110.1
|
%
|
||||
Expected
Life
|
6.0
years
|
5.9
years
|
||||||
Dividend
yield
|
0
|
0
|
||||||
Risk-free
interest rate
|
3.5
|
%
|
3.6
|
%
|
Warrants
Outstanding – October 31, 2008
|
97,187,400 | |||
Issued
New Warrants
|
40,716,625 | |||
Exercised
|
-3,333,333 | |||
Change
in Ratchet Calculation
|
-7,114,391 | |||
Warrants
Outstanding – October 31, 2009
|
127,456,301 | |||
October 31,
2009
|
October
31,
2008
|
|||||||
License
|
$
|
571,275
|
$
|
$529,915
|
||||
Patents
|
1,080,299
|
812,910
|
||||||
Total
intangibles
|
1,651,574
|
1,342,825
|
||||||
Accumulated
Amortization and impairments
|
279,936
|
205,428
|
||||||
Intangible
Assets
|
$
|
1,371,638
|
$
|
1,137,397
|
October 31,
2009
|
October 31,
2008
|
|||||||
Salaries
and other compensation
|
$ | 768,552 | $ | 430,256 | ||||
Sponsored
Research Agreement
|
119,698 | 119,698 | ||||||
Consultants
|
29,000 | 24,000 | ||||||
Warrants
|
— | 16,340 | ||||||
Clinical
Research Organization
|
— | 11,166 | ||||||
Other
|
— | 1,885 | ||||||
$ | 917,250 | $ | 603,345 |
Description
|
Principal
|
Purchase
Price
|
Original Issue
Discount
|
Maturity Date
|
||||||||||
Tranche
I-June 18, 2009
|
$ | 1,131,353 | $ | 961,650 | $ | 169,703 |
December
31, 2009
|
|||||||
Tranche
II-October 26, 2009
|
1,617,647 | 1,375,000 | 242,647 |
April
30, 2010
|
||||||||||
Tranche
III-October 30, 2009
|
529,412 | 450,000 | 79,412 |
April
30, 2010
|
||||||||||
Total
Bridge Notes
|
$ | 3,278,412 | $ | 2,786,650 | $ | 491,762 |
Bridge
Notes – Principal Value
|
$ | 3,278,412 | ||
Original
Issue Discount, net of accreted interest
|
(367,916 | ) | ||
Fair
Value of Attached Warrants at issuance
|
(940,512 | ) | ||
Fair
Value of Embedded Derivatives at issuance
|
(1,579,646 | ) | ||
Accreted
interest on embedded derivative and warrant liabilities
|
601,999 | |||
Convertible
Bridge Notes- as of October 31, 2009
|
$ | 922,337 | ||
Embedded
Derivatives Liability at October 31, 2009
|
1,086,514 | |||
Convertible Bridge
Notes and fair value of embedded derivative
|
$ | 2,078,851 |
Description
|
Principal
|
Original
Issue
Discount
|
Warrant
Liability
|
Embedded
Derivative
Liability
|
||||||||||||
Bridge
Note I-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 |
(i)
|
$0.20
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 319.25%, Life 145 to 1825 days, warrants outstanding
89,143,801.
|
(ii)
|
$0.135
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 319.25%, Life 145 to 1825 days warrants outstanding
123,269,393
|
(iii)
|
$0.055
exercise price, market price $0.11, risk free interest 1.00% to 2.86%,
volatility 170.16% to 191.53%, Life 620 to 1825 days, warrants outstanding
202,416,414
|
(i)
|
$0.20
exercise price, market price $0.13, risk free interest 0.01% to 2.3%,
volatility 89.7% to 211.6%, Life 10 to 1690 days warrants outstanding
86,739,676.
|
(ii)
|
$0.135
exercise price, market price $0.13, risk free interest 0.01% to 2.3%,
volatility 89.7% to 211.6%, Life 10 to 1690 days, warrants outstanding
120,865,268
|
(iii)
|
The
third assumption used at June 18, 2009 is no longer being used
given the events that could have triggered this assumption, in managements
estimation, are no longer probable.
|
·
|
$0.20/share
at a 50% conversion divided into $1,131,353 equals 11,313,530 shares plus
warrant & share dilution (1).
|
·
|
$0.10/share
at a 50% conversion divided into $1,131,353 equals 22,627,060 shares plus
warrant & share dilution (1).
|
·
|
$0.05/share
at a 50% conversion divided into $1,131,353 or 45,254,120 shares plus
warrant and share dilution (1).
|
·
|
$0.01/share
at a 50% conversion divided into $1,131,353 or 226,270,600 shares plus
warrant and share dilution (1).
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Life In
Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding
as of October 31, 2007
|
8,512,841 | $ | 0.22 | 7.8 | 167,572 | |||||||||||
Granted
|
300,000 | $ | 0.09 | — | — | |||||||||||
Cancelled
or Expired
|
— | $ | — | — | ||||||||||||
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 | |||||||||||
Vested
& Exercisable at October 31, 2009
|
11,611,174 | $ | 0.18 | 6.0 | $ | 102,667 |
|
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 | 9,950 | 9.3 | 0.10 | $ | 306,500 | 3,496 | $ | 0.10 | $ | 102,667 | |||||||||||||||||||
0.14-0.17 | 3,115 | 6.2 | $ | 0.15 | 0 | 2,906 | 0.15 | 0 | ||||||||||||||||||||||
0.18-0.21 | 1,739 | 4.0 | 0.21 | 0 | 1,720 | 0.21 | 0 | |||||||||||||||||||||||
0.22-0.25 | 296 | 4.3 | 0.24 | 0 | 213 | 0.24 | 0 | |||||||||||||||||||||||
0.26-0.29 | 2,992 | 5.1 | 0.28 | 0 | 2,954 | 0.28 | 0 | |||||||||||||||||||||||
0.30-0.43 | 322 | 3.3 | 0.37 | 322 | 0.37 | 0 | ||||||||||||||||||||||||
Total
|
18,332 | 6.0 | $ | 0.16 | $ | 306,500 | 11,611 | $ | 0.18 | $ | 102,667 |
A summary of the status of the Company’s nonvested shares as
of October 31, 2007, and changes during the years ended
|
Number of
Shares
|
Weighted
Average
Exercise
Price at
Grant
Date
|
Weighted Average
Remaining
Contractual Term
(in years)
|
|||||||||
Non-vested
shares at October 31, 2007
|
3,080,305
|
$
|
0.19
|
8.5
|
||||||||
Options
granted
|
300,000
|
$
|
0.09
|
9.4
|
||||||||
Options
vested
|
(1,967,027
|
)
|
$
|
0.18
|
7.5
|
|||||||
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
|
2009
|
2008
|
|||||||
Net
operating loss carryforwards-federal
|
$
|
7,786,507
|
6,452,027
|
|||||
Stock
based compensation
|
990,700
|
217,334
|
||||||
Research
and development tax credits
|
216,134
|
|||||||
Less
valuation allowance
|
(8,993,341
|
)
|
(6,669,360
|
)
|
||||
Deferred
tax asset
|
$
|
—
|
$
|
—
|
Year ended
October 31,
2009
|
Year ended
October 31,
2008
|
Period from
March 1, 2002
(inception) to
October 31,
2009
|
||||||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
||||||
—
|
%
|
—
|
%
|
—
|
%
|