Unassociated Document
Prospectus |
Filed
pursuant to Rule
424(b)(3)
|
Registration
No. 333-162632
ADVAXIS,
INC.
80,671,250
Shares
Common
Stock
This
prospectus relates to the resale of up to (i) 33,750,000 shares of our common
stock underlying a warrant issued to an affiliate of Optimus Capital Partners,
LLC, which we refer to as Optimus, in our September 2009 preferred equity
financing and (ii) 46,921,250 shares of our common stock underlying warrants
issued in connection with our October 2007 private placement. The
shares covered by this prospectus may be sold by the selling stockholders from
time to time in the over-the-counter market or other national securities
exchange or automated interdealer quotation system on which our common stock is
then listed or quoted, through negotiated transactions at negotiated prices or
otherwise at market prices prevailing at the time of sale.
Pursuant
to registration rights granted by us to the selling stockholders, we are
obligated to register the shares to be acquired upon exercise of warrants held
by these selling stockholders. The distribution of the shares by the
selling stockholders is not subject to any underwriting agreement. We
will receive none of the proceeds from the sale of shares by the selling
stockholders. The selling stockholders identified in this prospectus
will receive the proceeds from the sale of the shares. However, we
may receive the proceeds from the exercise of the warrants held by the selling
stockholders, if any, to the extent the warrants are not exercised on a cashless
basis. We will bear all expenses of registration incurred in
connection with this offering, but all selling and other expenses incurred by
the selling stockholders will be borne by them.
Our
common stock is quoted on the Over-The-Counter Bulletin Board, or OTC Bulletin
Board, under the symbol ADXS.OB. On November 3, 2009, the last
reported sale price per share for our common stock as reported by the OTC
Bulletin Board was $0.12.
Investing
in our common stock involves a high degree of risk. We urge you to
carefully consider the ‘‘Risk Factors’’ beginning on page 9.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of the prospectus. Any representation to the contrary is a
criminal offense.
The
date of this prospectus is November 6, 2009.
TABLE
OF CONTENTS
About
this Prospectus
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i
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Prospectus
Summary
|
1
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The
Offering
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8
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Risk
Factors
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9
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Special
Note Regarding Forward-Looking Statements
|
23
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Use
of Proceeds
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24
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Market
Price of and Dividends on Our Common Stock and Related Stockholder
Matters
|
24
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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25
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Description
of Business
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39
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Management
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59
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Executive
Compensation
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63
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Stock
Ownership
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70
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Selling
Stockholders
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72
|
Certain
Relationships and Related Transactions
|
76
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Description
of Our Capital Stock
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77
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Shares
Eligible for Future Sale
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81
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Plan
of Distribution
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83
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Legal
Matters
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85
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Experts
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85
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Interests
of Named Experts and Counsel
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85
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Where
You Can Find Additional Information
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85
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Financial
Statements
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F-1
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ABOUT
THIS PROSPECTUS
You
should only rely on the information contained in this prospectus. We
have not authorized anyone to give any information or make any representation
about this offering that differs from, or adds to, the information in this
prospectus or in its documents that are publicly filed with the
SEC. Therefore, if anyone does give you different or additional
information, you should not rely on it. The delivery of this
prospectus does not mean that there have not been any changes in our condition
since the date of this prospectus. If you are in a jurisdiction where
it is unlawful to offer the securities offered by this prospectus, or if you are
a person to whom it is unlawful to direct such activities, then the offer
presented by this prospectus does not extend to you. This prospectus
speaks only as of its date except where it indicates that another date
applies.
Market
data and certain industry forecasts used in this prospectus were obtained from
market research, publicly available information and industry publications. We
believe that these sources are generally reliable, but the accuracy and
completeness of such information is not guaranteed. We have not independently
verified this information, and we do not make any representation as to the
accuracy of such information.
In this
prospectus, the terms “we”, “us”, “our” and “our company” refer to Advaxis,
Inc., a Delaware corporation, resulting from the reincorporation of our company
from Colorado to Delaware described elsewhere in this prospectus (unless the
context references such entity prior to the June 20, 2006 reincorporation from
Colorado to Delaware, in which case it refers to the Colorado
entity).
The name
Advaxis is our trademark. Other trademarks and product names appearing in this
prospectus are the property of their respective owners.
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, breast cancer, prostate cancer, and other
cancers. Our lead products in development are as follows:
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 January 2010.
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Cervical
Cancer
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Phase II Company
sponsored study anticipated to commence in January 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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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,
2008 and July 31, 2009, we had an accumulated deficit of $17,533,044 and
$17,971,843, respectively, and shareholders’ deficiency of
$839,311 and $13,639,132, respectively.
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
On
September 24, 2009, we entered into a preferred stock purchase agreement with
Optimus, which we refer to as the Optimus purchase agreement, pursuant to which
Optimus has agreed to purchase, upon the terms and subject to the conditions set
forth therein and described below, up to $5.0 million of our newly authorized,
non-convertible, redeemable Series A preferred stock, which we refer to as our
Series A preferred stock, at a price of $10,000 per share.
Under the terms of the Optimus purchase agreement, from time to time
until September 24, 2012, in our sole discretion, we may present Optimus with a
notice to purchase a specified amount of Series A preferred stock, which Optimus
is obligated to purchase on the 10th trading day after the date of the notice,
subject to satisfaction of certain closing conditions. We will
determine, in our sole discretion, the timing and amount of Series A preferred
stock to be purchased by Optimus, and may sell such shares in multiple
tranches. Optimus will not be obligated to purchase the Series A
preferred stock upon our notice (i) in the event the closing price of our common
stock during the nine trading days following delivery of our notice falls below
75% of the closing price on the trading day prior to the date such notice is
delivered to Optimus or (ii) to the extent such purchase would result in Optimus
and its affiliates beneficially owning more than 9.99% of our outstanding common
stock.
The
Series A preferred stock is redeemable at our option on or after the fifth
anniversary of the date of its issuance. The Series A preferred stock also has a
liquidation preference per share equal to the original price per share thereof
plus all accrued dividends thereon, and is subject to repurchase by us at
Optimus’s election under certain circumstances, or following the consummation of
certain fundamental transactions by us, at the option of a majority of the
holders of the outstanding shares of our Series A preferred stock.
Holders
of Series A preferred stock will be entitled to receive dividends, which will
accrue in shares of Series A preferred stock on an annual basis at a rate equal
to 10% per annum from the issuance date. Accrued dividends will be payable upon
redemption of the Series A preferred stock. The Series A preferred stock ranks,
with respect to dividend rights and rights upon liquidation:
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senior
to our common stock and any other class or series of preferred stock
(other than a class or series of preferred stock that the we intend to
cause to be listed for trading or quoted on Nasdaq, NYSE Amex or the New
York Stock Exchange); and
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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.
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The
Optimus purchase agreement further provides that we will pay to Optimus a
non-refundable fee of up to $250,000, $125,000 of which was paid in cash on
October 28, 2009, and $125,000 of which shall be paid on the closing date
of the first tranche (by offset from the gross proceeds of such
tranche).
In
addition, at the time of execution of the Optimus purchase agreement, we issued
to an affiliate of Optimus a three-year warrant to purchase up to 33,750,000
shares of our common stock, at an initial exercise price of $0.20 per share,
subject to adjustment as provided in the warrant. The warrant will become
exercisable on the earlier of (i) the date on which a registration statement
registering for resale the shares of our common stock issuable upon exercise of
the warrant becomes effective and (ii) the first date on which such shares
underlying the warrant are eligible for resale without limitation under Rule 144
(assuming a cashless exercise of the warrant). The exercise price of the warrant
may be paid (at the option of Optimus) in cash or by Optimus’s issuance of a
four-year, full-recourse promissory note, bearing interest at 2% per annum, and
secured by specified portfolio of assets owned by Optimus. The warrant also
provides for cashless exercise if at any time a registration statement is not
effective (or the prospectus contained therein is not available for use) for the
resale of the shares underlying the warrant. If
Optimus fails to acquire and pay for the Series A preferred stock upon delivery
of our notice in accordance with the terms of the Optimus purchase agreement
(assuming the timely and full satisfaction of all of the conditions set forth
therein) and the warrant has not previously been exercised in full, we
have the right to demand surrender of the warrant (or any remaining portion
thereof) without compensation, and the warrant shall automatically be
cancelled.
Our right
to deliver a notice to Optimus requiring Optimus to make a purchase, and the
obligation of Optimus to accept a notice and to acquire and pay for the Series A
preferred stock subject to such notice at a tranche closing, are subject to the
satisfaction (or waiver) of certain conditions, which include, among
others:
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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;
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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);
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there
must not be any material adverse effect with respect to the company since
the date we executed the Optimus purchase agreement, other than losses
incurred in the ordinary course of
business;
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we
must not be in default under any material
agreement;
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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;
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there
must not be any legal restraint prohibiting the transactions contemplated
by the Optimus purchase agreement;
and
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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.
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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 adjustments upon the
occurrence of certain events. As of
November 3, 2009, we completed a private placement with certain accredited
investors pursuant to which we issued
(i) junior unsecured convertible promissory notes in the aggregate principal
face amount of $2,088,235, for an aggregate net purchase price of $1,775,000 and
(ii) warrants to purchase 4,437,500 shares of our common stock at an exercise
price of $0.20 per share, subject to adjustments upon the occurrence of certain
events. We refer to these capital raises as the June 2009
bridge financing and October 2009 bridge financing, respectively. We
refer to the notes and warrants issued in the June 2009 bridge financing as the
June 2009 bridge notes and June 2009 bridge warrants, respectively, and the
notes and warrants issued in the October 2009 bridge financing as the October
2009 bridge notes and October 2009 bridge warrants,
respectively.
Each
of the June 2009 bridge notes and October 2009 bridge notes were issued with an
original issue discount of 15% and are convertible into shares of our common
stock as described below. The June
2009 bridge notes mature on December 31, 2009. With
respect to the October 2009 bridge notes, $58,824 of the face amount matures on
the later of (i) March 31, 2010 and (ii) the repayment in full or conversion of
the June 2009 bridge notes (and any other senior indebtedness), and $2,029,412
of the face amount matures on the later of (i) April 30, 2010 and (ii)
the repayment in full or conversion of the June 2009 bridge notes (and any other
senior indebtedness). We may prepay the June 2009 bridge notes and
October 2009 bridge notes, in whole or in part, without penalty at any time
prior to the respective maturity date.
The
indebtedness represented by the October 2009 bridge notes is expressly
subordinate to our currently outstanding senior secured indebtedness (including
the June 2009 bridge notes), as well as any future senior indebtedness of any
kind. We will not make any payments to the holders of the October
2009 bridge notes until the earlier of the repayment in full or conversion of
the senior indebtedness.
Each of
the June 2009 bridge warrants and October 2009 bridge warrants may be exercised
on a cashless basis under certain circumstances.
In the
event we consummate an equity financing with aggregate gross proceeds of not
less than $2.0 million, which we refer to as a qualified equity financing, prior
to the second business day immediately preceding the maturity date of the June
2009 bridge notes or October 2009 bridge notes, as the case may be, then prior
to the respective maturity date, the holders will have the option to convert all
or a portion of the respective notes into the same securities sold in such
qualified equity financing at an effective per share conversion price equal to
90% of the per share purchase price of the securities issued in the qualified
equity financing. In the event we do not consummate a qualified
equity financing prior to the second business day immediately preceding the
respective maturity date, then the holders shall have the option to convert all
or a portion of the June 2009 bridge notes or October 2009 bridge notes, as the
case may be, into shares of common stock, at an effective per share conversion
price equal to 50% of the volume-weighted average price per share of our common
stock over the five consecutive trading days immediately preceding the third
business day prior to the maturity date. To the extent a holder does
not elect to convert its bridge notes as described above, the principal amount
of the bridge notes not so converted shall be payable in cash on the respective
maturity date.
Amendment
to Moore Notes
On
September 22, 2008, we entered into a note purchase agreement with our Chief
Executive Officer, Thomas A. Moore, pursuant to which we agreed to sell to Mr.
Moore, from time to time, one or more senior promissory notes, which we refer to
as the Moore Notes. On June 15, 2009, we amended the terms of the
Moore Notes to increase the amounts available from $800,000 to $950,000 and to
change the maturity date of the Moore Notes from June 15, 2009 to the earlier of
January 1, 2010 or our next equity financing resulting in gross proceeds to us
of at least $6.0 million.
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 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 June 2009 bridge financing increasing the number of shares underlying the
warrant from one share per $1.00 invested to two and one-half shares. The final
terms are anticipated to contain the same terms and conditions as warrants
issued to investors in the subsequent financing. As of July 31, 2009,
$947,985 in notes were outstanding and payable to Mr. Moore.
Grants
and Other Developments
As of
October 1, 2009, we updated survival data for our Phase I clinical trial of
ADXS11-001 in the treatment of advanced, metastatic cervix patients who have
failed first line cytotoxic therapy and three of the 13 evaluable patients
in the trial, approximately twenty-three percent (23%), are still alive at 1091
days, 1059 days and 960 days, respectively. The trial’s median patient survival
was 347 days. Of the 15 patients treated in the trial, eight patients (53%)
survived at least one year. These figures significantly exceed the median
survival rate established by the GOG. The GOG’s median survival rate varies
between 3.8 and 6.2 months in studies of patients who have failed prior
chemotherapy (GOG #127 protocol series) with a 1 year survival of approximately
5%.
On August
19, 2009, the National Institute of Health, which we refer to as the NIH,
awarded us a grant for $210,000 to develop a single bioengineered Lm vaccine to
deliver two different antigen-adjuvant proteins. This technology enables a
single vaccine to simultaneously attack two separate and distinct tumor targets
with a higher level of potency. Further investigational work is focusing on the
use of this dual delivery approach directed against a tumor cell surface marker
to kill tumor cells directly plus an anti-angiogenic target that would impair a
tumor’s ability to grow by simultaneously reducing its blood
supply.
On August
19, 2009, we announced our collaboration with investigators with the City of
Hope, which we refer to as the CoH. The CoH is a leading biomedical
research and treatment center in the development of a vaccine for the treatment
of certain forms of leukemia and lymphoma. This collaboration will involve the
investigation in the use of our proprietary, live Listeria vaccine technology
platform for Leukemia and Lymphoma. The CoH investigators are studying our
vaccine directed against the tumor associated antigen WT-1. This molecule is
observed to be over-expressed in certain cancers of the blood, such as
lymphoma, as well as some solid tumors such as breast, pancreas and brain
cancers, which makes it a potential target for a selective immune attack
delivered via a Listeria vector designed by
us. We also have research relationships with Roswell Park Research Institute for
the use of our WT-1 vaccine and with the University of Pittsburgh for the
development of vaccines that use the antigens HMW-MAA and
IL-13R2α.
In July
2009, we were notified that while our grant application filed with Cancer
Research-UK, a national philanthropy, for the use of ADXS11-001 in the treatment
of head and neck cancer in collaboration with investigators from Aintree
Hospital (Liverpool), The Royal Marsden Hospital (London), and at Cardiff
University, was well received by the New Agents Committee, it was not
prioritized for funding at the present time. With encouragement from CR-UK that
grant has been resubmitted and is currently pending.
On June
1, 2009, we received an FDA letter denying our request for Orphan Drug
Designation for the use of ADXS11-001 in invasive cervical cancer. The FDA
stated their market definition for invasive cervical cancer prevalence
(including all those who had been cured) is over the 200,000 person
cut-off. As part of our strategy to enhance our development efforts,
on July 31, 2009, we filed a request for Fast Track Drug Designation in cervical
cancer with the FDA. The FDA could not grant Fast Track Designation
based on our initial application but has provided guidance for
re-application. We are using this guidance to provide additional
information in order to re-apply.
In June
2009, we engaged Numoda Corporation, which we refer to as Numoda, a clinical
trial and logistics management company, to oversee Phase II clinical activity
with ADXS11-001 for the treatment of invasive cervix cancer in India and to
serve as the clinical research organization in our CIN trial in the U.S. Numoda
will integrate oversight and logistical functions with the contract
laboratories, academic laboratories and statistical groups involved both in the
U.S. as well as with the clinical research organization to be selected in
India. We estimate the cost of this agreement for both clinical
trials to be approximately $8.0 million through September 2011.
On May
20, 2009, we announced that we applied for a $2.0 million U.S. Bio-Defense
Grant, in collaboration with a healthcare company, to develop an oral
formulation of its live Listeria technology for the
prevention of influenza. In addition, on May 4, 2009, we announced
that we applied for nearly $5.0 million in Grants in Response to U.S. Department
of Defense Solicitation in three separate grant proposals. On April 27, 2009 we
announced that we applied for approximately $1.0 million worth of grants from
the NIH.
On
February 10, 2009 the PTO issued patent 7,488,487 “Methods of Inducing Immune response
Through the Administration of Auxotrophic Attenuated DAT/DAL Double Mutant
Listeria Strains”, assigned to Penn and licensed to us. This
intellectual property protects a unique strain of Listeria monocytogenes for use as a
vaccine vector. This new strain of Listeria is an improvement
over the strain currently in clinical testing as it is more attenuated, more
immunogenic, and does not have an antibiotic resistance gene
inserted. We believe that this technology will make our product more
effective and easier to obtain FDA regulatory approval.
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.
THE
OFFERING
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 80,671,250 shares of our common stock consisting
of:
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33,750,000
shares of our common stock underlying a warrant issued to an affiliate of
Optimus in our September 2009 preferred equity financing (1);
and
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46,921,250
shares of our common stock underlying warrants issued in connection with
our October 2007 private placement.
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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. We would receive
proceeds of approximately $16,134,250 from the cash
exercise of such warrants, 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)
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These
shares represent 29.2% of our currently outstanding shares of common stock
(based on 115,638,243 shares of common stock outstanding as of October 1,
2009).
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RISK
FACTORS
An
investment in our common stock is highly speculative, involves a high degree of
risk and should be made only by investors who can afford a complete loss of
their investment. You should carefully consider, together with the
other matters referred to in this prospectus, the following risk factors before
you decide whether to buy our common stock.
Risks
Related to our Business
We
are a development stage company.
We are an
early stage development stage company with a history of losses and can provide
no assurance as to future operating results. As a result of losses
which will continue throughout our development stage, we may exhaust our
financial resources and be unable to complete the development of our
production. Our deficit will continue to grow during our drug
development period.
We have
sustained losses from operations in each fiscal year since our inception, and we
expect losses to continue for the indefinite future, due to the substantial
investment in research and development. As of October 31, 2008 and
July 31, 2009, we had an accumulated deficit of $17,533,044 and $17,971,843,
respectively, and shareholders’ deficiency of $839,311 and
$13,639,132, respectively. We expect to spend substantial additional
sums on the continued administration and research and development of proprietary
products and technologies with no certainty that our products will become
commercially viable or profitable as a result of these
expenditures.
As
a result of our current lack of financial liquidity and negative stockholders
equity, our auditors have expressed substantial concern about our ability to
continue as a “going concern” .
Our
limited capital resources and operations to date have been funded primarily with
the proceeds from public and private equity and debt financings, NOL tax credit
and income earned on investments and grants. Based on our currently
available cash, we do not have adequate cash on hand to cover our anticipated
expenses for the next 12 months. If we fail to raise a significant
amount of capital, we may need to significantly curtail operations, cease
operations or seek federal bankruptcy protection in the near future. These
conditions have caused our auditors to raise substantial doubt about our ability
to continue as a going concern. Consequently, the audit report
prepared by our independent public accounting firm relating to our financial
statements for the year ended October 31, 2008 included a going concern
explanatory paragraph.
There
can be no assurance that we will receive funding from Optimus in connection with
the preferred equity financing.
We have entered into the Optimus
purchase agreement, pursuant to which Optimus has agreed to purchase up to $5.0
million of our Series A preferred stock from time to time, subject to our
ability to effect and maintain an effective registration statement for the
shares underlying the warrant issued to an affiliate of Optimus to purchase
33,750,000 shares of common stock, issued in connection with the
transaction. Additionally, the Optimus purchase
agreement provides that in order to require Optimus to purchase our Series
A preferred stock at any time: (i) we must be in compliance with our SEC
reporting obligations, (ii) our common stock must be quoted on the OTC
Bulletin Board or another eligible trading market, (iii) a material adverse
effect relating
to, among other things, our results of operations, assets, business or
financial condition must not have occurred since September 24, 2009,
other than losses incurred in the ordinary course of business, (iv) we must not
be in default under any material agreement, and (v) Optimus and its
affiliates must not own more than 9.99% of our outstanding common stock,
and (vi) we must comply with certain other requirements set forth in the Optimus
purchase agreement. If we fail to comply with any of these
requirements, Optimus will not be obligated to purchase our Series A preferred
stock and we will not receive any funding from Optimus. Moreover,
if we exercise our option to require Optimus to purchase our Series A preferred
stock, and our common stock has a closing price of less than $0.20 per share on
the trading day immediately preceding our delivery of the exercise notice, we
will trigger at closing certain anti-dilution protection provisions in certain
outstanding warrants that would result in an adjustment to the number and price
of certain outstanding warrants.
Our
business will require substantial additional investment that we have not yet
secured, and our failure to raise capital and/or pursue partnering opportunities
will materially adversely affect our business, financial condition and results
of operations.
We expect
to continue to spend substantial amounts on research and development, including
conducting clinical trials for our product candidates. However, we will not have
sufficient resources to develop fully any new products or technologies unless we
are able to raise substantial additional financing on acceptable terms, secure
funds from new partners or consummate a preferred equity financing under the
Optimus purchase agreement. We cannot be assured that financing will be
available at all. Our failure to raise a significant amount of
capital in the near future, will materially adversely affect our business,
financial condition and results of operations, and we may need to significantly
curtail operations, cease operations or seek federal bankruptcy protection in
the near future. Any additional investments or resources required
would be approached, to the extent appropriate in the circumstances, in an
incremental fashion to attempt to cause minimal disruption or
dilution. Any additional capital raised through the sale of equity or
convertible debt securities will result in dilution to our existing
stockholders. No assurances can be given, however, that we will be
able to achieve these goals or that we will be able to continue as a going
concern.
We
have significant indebtedness which may restrict our business and operations,
adversely affect our cash flow and restrict our future access to sufficient
funding to finance desired growth.
As of
July 31, 2009, the face value of our outstanding indebtedness notes was
approximately $2.1 million, of which $0.9 million is outstanding to our chief
executive officer. The total face value of the notes
outstanding as of July 31, 2009 is due on or before January 1,
2010. We dedicate a substantial portion of our cash to pay interest
and principal on our debt. If we are not able to service our debt, we would need
to refinance all or part of that debt, sell assets, borrow more money or sell
securities, which we may not be able to do on commercially reasonable terms, or
at all.
As of
July 31, 2009, $1.1 million of this indebtedness is secured by substantially all
of our assets. The terms of our notes include customary events of default and
covenants that restrict our ability to incur additional indebtedness. These
restrictions and covenants may prevent us from engaging in transactions that
might otherwise be considered beneficial to us. A breach
of the provisions of our indebtedness could result in an event of default under
our outstanding notes. If an event of default occurs under our notes
(after any applicable notice and cure periods), the holders would be entitled to
accelerate the repayment of amounts outstanding, plus accrued and unpaid
interest. In the event of a default under our senior
indebtedness, the holders could also foreclose against the assets securing such
obligations. In the event of a foreclosure on all or substantially
all of our assets, we may not be able to continue to operate as a going
concern.
Our
limited operating history does not afford investors a sufficient history on
which to base an investment decision.
We
commenced our Listeria
System vaccine development business in February 2002 and have existed as a
development stage company since such time. Prior thereto we conducted
no business. Accordingly, we have a limited operating
history. Investors must consider the risks and difficulties we have
encountered in the rapidly evolving vaccine and therapeutic biopharmaceutical
industry. Such risks include the following:
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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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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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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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We cannot
be certain that our strategy will be successful or that we will successfully
address these risks. In the event that we do not successfully address
these risks, our business, prospects, financial condition and results of
operations could be materially and adversely affected. We may be
required to reduce our staff, discontinue certain research or development
programs of our future products and cease to operate.
We
can provide no assurance of the successful and timely development of new
products.
Our
products are at various stages of research and development. Further
development and extensive testing will be required to determine their technical
feasibility and commercial viability. Our success will depend on our
ability to achieve scientific and technological advances and to translate such
advances into reliable, commercially competitive products on a timely
basis. Immunotherapy and vaccine products that we may develop are not
likely to be commercially available until five to ten or more
years. The proposed development schedules for our products may be
affected by a variety of factors, including technological difficulties,
proprietary technology of others, and changes in governmental regulation, many
of which will not be within our control. Any delay in the
development, introduction or marketing of our products could result either in
such products being marketed at a time when their cost and performance
characteristics would not be competitive in the marketplace or in the shortening
of their commercial lives. In light of the long-term nature of our
projects, the unproven technology involved and the other factors described
elsewhere in “Risk Factors,” there can be no assurance that we will be able to
successfully complete the development or marketing of any new
products.
Our
research and development expenses are subject to uncertainty.
Factors
affecting our research and development expenses include, but are not limited
to:
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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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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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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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dependence
upon key personnel including key independent consultants and
advisors.
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We
are subject to numerous risks inherent in conducting clinical
trials.
We
outsourced our clinical trials and entered into a contract with Numoda to manage
the execution of two Phase II trials for the assessment of our agent ADXS11-001
in the treatment of advanced cervix cancer in women who have failed prior
cytotoxic treatment, and in the treatment of CIN, the precursor condition to
cervix cancer. We expect to conduct the CIN trial in the U.S. and we
expect to conduct the cervix cancer trial in India in association with the
clinical research organization Max Neeman International These trials
are scheduled to begin on or about January 2010.
Agreements
with clinical investigators and medical institutions for clinical testing and
with other third parties for data management services, place substantial
responsibilities on these parties which, if unmet, could result in delays in, or
termination of, our clinical trials. For example, if any of our
clinical trial sites fail to comply with FDA-approved good clinical practices,
we may be unable to use the data gathered at those sites. If these
clinical investigators, medical institutions or other third parties do not carry
out their contractual duties or obligations or fail to meet expected deadlines,
or if the quality or accuracy of the clinical data they obtain is compromised
due to their failure to adhere to our clinical protocols or for other reasons,
our clinical trials may be extended, delayed or terminated, and we may be unable
to obtain regulatory approval for or successfully commercialize our agent
ADXS11-001. We are not certain that we will successfully recruit enough patients
to complete our clinical trials. Delays in recruitment and such
agreements would delay the initiation of the Phase II trials of
ADXS11-001.
We or our
regulators may suspend or terminate our clinical trials for a number of
reasons. We may voluntarily suspend or terminate our clinical trials
if at any time we believe they present an unacceptable risk to the patients
enrolled in our clinical trials. In addition, regulatory agencies may
order the temporary or permanent discontinuation of our clinical trials at any
time if they believe that the clinical trials are not being conducted in
accordance with applicable regulatory requirements or that they present an
unacceptable safety risk to the patients enrolled in our clinical
trials.
Our
clinical trial operations are subject to regulatory inspections at any
time. If regulatory inspectors conclude that we or our clinical trial
sites are not in compliance with applicable regulatory requirements for
conducting clinical trials, we may receive reports of observations or warning
letters detailing deficiencies, and we will be required to implement corrective
actions. If regulatory agencies deem our responses to be inadequate,
or are dissatisfied with the corrective actions we or our clinical trial sites
have implemented, our clinical trials may be temporarily or permanently
discontinued, we may be fined, we or our investigators may be precluded from
conducting any ongoing or any future clinical trials, the government may refuse
to approve our marketing applications or allow us to manufacture or market our
products, and we may be criminally prosecuted.
The
successful development of biopharmaceuticals is highly uncertain.
Successful
development of biopharmaceuticals is highly uncertain and is dependent on
numerous factors, many of which are beyond our control. Products that
appear promising in the early phases of development may fail to reach the market
for several reasons including:
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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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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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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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Success
in preclinical and early clinical studies does not ensure that large-scale
clinical studies will be successful. Clinical results are frequently
susceptible to varying interpretations that may delay, limit or prevent
regulatory approvals. The length of time necessary to complete
clinical studies and to submit an application for marketing approval for a final
decision by a regulatory authority varies significantly from one product to the
next, and may be difficult to predict.
We
must comply with significant government regulations.
The
research and development, manufacture and marketing of human therapeutic and
diagnostic products are subject to regulation, primarily by the FDA in the U.S.
and by comparable authorities in other countries. These national
agencies and other federal, state, local and foreign entities regulate, among
other things, research and development activities (including testing in animals
and in humans) and the testing, manufacturing, handling, labeling, storage,
record keeping, approval, advertising and promotion of the products that we are
developing. Noncompliance with applicable requirements can result in
various adverse consequences, including delay in approving or refusal to approve
product licenses or other applications, suspension or termination of clinical
investigations, revocation of approvals previously granted, fines, criminal
prosecution, recall or seizure of products, injunctions against shipping
products and total or partial suspension of production and/or refusal to allow a
company to enter into governmental supply contracts.
The
process of obtaining requisite FDA approval has historically been costly and
time-consuming. Current FDA requirements for a new human biological
product to be marketed in the U.S. include: (1) the successful conclusion of
preclinical laboratory and animal tests, if appropriate, to gain preliminary
information on the product’s safety; (2) filing with the FDA of an
Investigational New Drug Application, which we refer to as an IND, to conduct
human clinical trials for drugs or biologics; (3) the successful completion of
adequate and well-controlled human clinical investigations to establish the
safety and efficacy of the product for its recommended use; and (4) filing by a
company and acceptance and approval by the FDA of a Biologic License
Application, which we refer to as a BLA, for a biological product, to allow
commercial distribution of a biologic product. A delay in one or more
of the procedural steps outlined above could be harmful to us in terms of
getting our product candidates through clinical testing and to
market.
We
can provide no assurance that our products will obtain regulatory approval or
that the results of clinical studies will be favorable.
In
February 2006, we received permission from the appropriate governmental agencies
in Israel, Mexico and Serbia to conduct Phase I clinical testing of ADXS11-001,
our Listeria-based
cancer vaccine that targets cervical cancer in women in those
countries. The study was completed in the fiscal quarter ended
January 31, 2008. The next step was to test, market and manufacture
our product for sale or distribution in the U.S. which required a filing of an
IND with the FDA for our Phase II CIN trial. The filing was based on information
from the Phase I trial and other pre-clinical information. On January 6, 2009 we
received permission to conduct our clinical trial under this IND from the
FDA. However, even though we are allowed to conduct this trial, as
with any experimental agent, we are always at risk to be placed on clinical hold
by the FDA at any time as our product may have effects on humans are not fully
understood or documented. There can be delays in obtaining FDA or any
other necessary regulatory approvals of any proposed product and failure to
receive such approvals would have an adverse effect on the product’s potential
commercial success and on our business, prospects, financial condition and
results of operations. In addition, it is possible that a product may
be found to be ineffective or unsafe due to conditions or facts which arise
after development has been completed and regulatory approvals have been
obtained. In this event, we may be required to withdraw such product
from the market. To the extent that our success will depend on any
regulatory approvals from governmental authorities outside of the U.S. that
perform roles similar to that of the FDA, uncertainties similar to those stated
above will also exist.
We
rely upon patents to protect our technology. We may be unable to
protect our intellectual property rights and we may be liable for infringing the
intellectual property rights of others.
Our
ability to compete effectively will depend on our ability to maintain the
proprietary nature of our technologies, including the Listeria System, and the
proprietary technology of others with which we have entered into licensing
agreements. As of July 31, 2009 we have licensed 21 patents that
have been issued and licenses for 24 patents are pending from Penn filed in some
of the largest markets in the world. Further, we rely on a
combination of trade secrets and nondisclosure, and other contractual agreements
and technical measures to protect our rights in the technology. We
depend upon confidentiality agreements with our officers, employees,
consultants, and subcontractors to maintain the proprietary nature of the
technology. These measures may not afford us sufficient or complete
protection, and others may independently develop technology similar to ours,
otherwise avoid the confidentiality agreements, or produce patents that would
materially and adversely affect our business, prospects, financial condition,
and results of operations. Such competitive events, technologies and
patents may limit our ability to raise funds, prevent other companies from
collaborating with us, and in certain cases prevent us from further developing
our technology due to third party patent blocking rights.
We are
aware of a private company, Anza Therapeutics, Inc (formerly Cerus Corporation),
which is no longer in existence, but had been developing Listeria
vaccines. We believe that through our exclusive license with Penn we
have earliest known and dominant patent position in the U.S. for the use of
recombinant Listeria
monocytogenes expressing proteins or tumor antigens as a vaccine for the
treatment of infectious diseases and tumors. We successfully defended
our intellectual property by contesting a challenge made by Anza to our patent
position in Europe on a claim not available in the U.S. The European
Patent Office, which we refer to as the EPO, Board of Appeals in Munich, Germany
has ruled in favor of The Trustees of Penn and its exclusive licensee Advaxis
and reversed a patent ruling that revoked a technology patent that had resulted
from an opposition filed by Anza. The ruling of the EPO Board of
Appeals is final and can not be appealed. The granted claims, the
subject matter of which was discovered by Dr. Yvonne Paterson, scientific
founder of Advaxis, are directed to the method of preparation and composition of
matter of recombinant bacteria expressing tumor antigens for treatment of
patients with cancer. Based on searches of publicly available
databases, we do not believe that Anza or any other third party owns any
published Listeria
patents or has any issued patent claims that might materially and
adversely affect our ability to operate our business as currently
contemplated in the field of recombinant Listeria
monocytogenes. Additionally, our proprietary position that is the
issued patents and licenses for pending applications restricts anyone from using
plasmid based Listeria
constructs, or those that are bioengineered to deliver antigens fused to LLO,
ActA, or fragments of LLO or ActA.
We
are dependent upon our license agreement with Penn; if we fail to make payments
due and owing to Penn under our license agreement, our business will be
materially and adversely affected.
Although
we have obtained licenses with regard to the use of Penn’s patents as described
herein, we can provide no assurance that such licenses will not be terminated or
expire during critical periods, that we will be able to obtain licenses for
other rights which may be important to us, or, if obtained, that such licenses
will be obtained on commercially reasonable terms.
Pursuant
to an option contained in our existing license agreement with Penn, as amended,
we have been in negotiations with Penn since March 2007 to further amend and
restate the terms of the license agreement to acquire the rights to use an
additional 12 dockets (patentable research agents) under Penn’s ownership which,
as of July 31, 2009, have generated approximately 22 additional patent
applications for Listeria and LLO-based
vaccine dockets. As a
condition to our exercising this option and entering into an amendment, we must,
among other things, pay Penn a mutually agreeable option exercise fee and
reimburse Penn for all of its historically accrued patent and licensing expenses
relating to these patents (dockets), including their legal and filing
fees. As of July 31, 2009, such expenses totaled approximately
$447,000. Although the option exercise period formally expired in
June 2009, we remain in negotiations with Penn over the form of payment and
expect to reach a conclusion at the close of our next financial
raise. If we fail to acquire a license to use the additional dockets
and patent applications, our patent position may be materially and
adversely affected. In addition, as of July 31, 2009, approximately
$315,000 in fees and expense are due and owing to Penn by us under our existing
license agreement and other related agreements. While we consider our
relationship with Penn to be good, we are in frequent communications over
payment of past due invoices and other payables due to our lack of
cash. If we fail to reach a mutual agreement, Penn may issue a
default notice and we will have 60 days to cure the breach or be subject to the
termination of the agreement.
If we are
unable to maintain and/or obtain licenses, we may have to develop alternatives
to avoid infringing on the patents of others, potentially causing increased
costs and delays in product development and introduction or precluding the
development, manufacture, or sale of planned products. Some of our licenses
provide for limited periods of exclusivity that require minimum license fees and
payments and/or may be extended only with the consent of the licensor. We can
provide no assurance that we will be able to meet these minimum license fees in
the future or that these third parties will grant extensions on any or all such
licenses. This same restriction may be contained in licenses obtained in the
future. Additionally, we can provide no assurance that the patents underlying
any licenses will be valid and enforceable. Furthermore, in 2001, an issue arose
regarding the inventorship of U.S. Patent 6,565,852 and U.S. Patent Application
No. 09/537,642. These patent rights are included in the patent rights licensed
by us from Penn. GlaxoSmithKline plc, Penn and we expect that the issue will be
resolved through a correction of inventorship to add certain GSK inventors,
where necessary and appropriate, an assignment of GSK’s possible rights under
these patent rights to Penn, and a sublicense from us to GSK of certain subject
matter, which is not central to our business plan. To date, this arrangement has
not been finalized and we cannot assure that this issue will ultimately be
resolved in the manner described above. To the extent any products developed by
us are based on licensed technology, royalty payments on the licenses will
reduce our gross profit from such product sales and may render the sales of such
products uneconomical.
We
have no manufacturing, sales, marketing or distribution capability and we must
rely upon third parties for such.
We do not
intend to create facilities to manufacture our products and therefore are
dependent upon third parties to do so. We currently have an agreement
with Cobra Manufacturing for production of our immunotherapies and vaccines for
research and development and testing purposes. Our reliance on third
parties for the manufacture of our products creates a dependency that could
severely disrupt our research and development, our clinical testing, and
ultimately our sales and marketing efforts if the source of such supply proves
to be unreliable or unavailable. If the contracted manufacturing
source is unreliable or unavailable, we may not be able to replace the
development of our product candidates, our clinical testing program may not be
able to go forward and our entire business plan could fail.
If
we are unable to establish or manage strategic collaborations in the future, our
revenue and product development may be limited.
Our
strategy includes eventual substantial reliance upon strategic collaborations
for marketing and commercialization of ADXS11-001, and we may rely even more on
strategic collaborations for research, development, marketing and
commercialization of our other product candidates. To date, we have
not entered into any strategic collaborations with third parties capable of
providing these services although we have been heavily reliant upon third party
outsourcing for our clinical trials execution. In addition, we have
not yet marketed or sold any of our product candidates or entered into
successful collaborations for these services in order to ultimately
commercialize our product candidates. Establishing strategic
collaborations is difficult and time-consuming. Our discussion with
potential collaborators may not lead to the establishment of collaborations on
favorable terms, if at all. For example, potential collaborators may
reject collaborations based upon their assessment of our financial, regulatory
or intellectual property position. If we successfully establish new
collaborations, these relationships may never result in the successful
development or commercialization of our product candidates or the generation of
sales revenue. To the extent that we enter into co-promotion or other
collaborative arrangements, our product revenues are likely to be lower than if
we directly marketed and sold any products that we may develop.
Management
of our relationships with our collaborators will require:
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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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If we
continue to enter into research and development collaborations at the early
phases of product development, our success will in part depend on the
performance of our corporate collaborators. We will not directly
control the amount or timing of resources devoted by our corporate collaborators
to activities related to our product candidates. Our corporate
collaborators may not commit sufficient resources to our research and
development programs or the commercialization, marketing or distribution of our
product candidates. If any corporate collaborator fails to commit
sufficient resources, our preclinical or clinical development programs related
to this collaboration could be delayed or terminated. Also, our
collaborators may pursue existing or other development-stage products or
alternative technologies in preference to those being developed in collaboration
with us. Finally, if we fail to make required milestone or royalty
payments to our collaborators or to observe other obligations in our agreements
with them, our collaborators may have the right to terminate those
agreements.
We
may incur substantial liabilities from any product liability claims if our
insurance coverage for those claims is inadequate.
We face
an inherent risk of product liability exposure related to the testing of our
product candidates in human clinical trials, and will face an even greater risk
if the product candidates are sold commercially. An individual may
bring a liability claim against us if one of the product candidates causes, or
merely appears to have caused, an injury. If we cannot successfully
defend ourselves against the product liability claim, we will incur substantial
liabilities. Regardless of merit or eventual outcome, liability
claims may result in:
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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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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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We must
bind insurance coverage before our Phase II CIN and cervical cancer trials begin
for each clinical trial site. We do not have product liability
insurance because we do not have products on the market. We currently
are in the process of obtaining insurance coverage and to expand such coverage
to include the sale of commercial products if marketing approval is obtained for
any of our product candidates. However, insurance coverage is
increasingly expensive and we may not be able to maintain insurance coverage at
a reasonable cost and we may not be able to obtain insurance coverage that will
be adequate to satisfy any liability that may arise.
We
may incur significant costs complying with environmental laws and
regulations.
We and
our contracted third parties will use hazardous materials, including chemicals
and biological agents and compounds that could be dangerous to human health and
safety or the environment. As appropriate, we will store these
materials and wastes resulting from their use at our or our outsourced
laboratory facility pending their ultimate use or disposal. We will
contract with a third party to properly dispose of these materials and
wastes. We will be subject to a variety of federal, state and local
laws and regulations governing the use, generation, manufacture, storage,
handling and disposal of these materials and wastes. We may also
incur significant costs complying with environmental laws and regulations
adopted in the future.
If
we use biological and hazardous materials in a manner that causes injury, we may
be liable for damages.
Our
research and development and manufacturing activities will involve the use of
biological and hazardous materials. Although we believe our safety
procedures for handling and disposing of these materials will comply with
federal, state and local laws and regulations, we cannot entirely eliminate the
risk of accidental injury or contamination from the use, storage, handling or
disposal of these materials. We do not carry specific biological or
hazardous waste insurance coverage, workers compensation or property and
casualty and general liability insurance policies which include coverage for
damages and fines arising from biological or hazardous waste exposure or
contamination. Accordingly, in the event of contamination or injury,
we could be held liable for damages or penalized with fines in an amount
exceeding our resources, and our clinical trials or regulatory approvals could
be suspended or terminated.
We
need to attract and retain highly skilled personnel; we may be unable to
effectively manage growth with our limited resources.
As of
October 1, 2009, we had ten employees. We do not intend to
significantly expand our operations and staff unless we get adequate
financing. If funded then our new employees may include key
managerial, technical, financial, research and development and operations
personnel who will not have been fully integrated into our
operations. We will be required to expand our operational and
financial systems significantly and to expand, train and manage our work force
in order to manage the expansion of our operations. Our failure to
fully integrate any new employees into our operations could have a material
adverse effect on our business, prospects, financial condition and results of
operations.
As of
January 1, 2009, we operate under an agreement with AlphaStaff, a professional
employment organization that provides us with payroll and human resources
services. Our ability to attract and retain highly skilled personnel
is critical to our operations and expansion. We face competition for
these types of personnel from other technology companies and more established
organizations, many of which have significantly larger operations and greater
financial, technical, human and other resources than we have. We may
not be successful in attracting and retaining qualified personnel on a timely
basis, on competitive terms, or at all. If we are not successful in
attracting and retaining these personnel, our business, prospects, financial
condition and results of operations will be materially adversely
affected. In such circumstances we may be unable to conduct certain
research and development programs, unable to adequately manage our clinical
trials and other products, and unable to adequately address our
management needs. As of the pay period ending January 4, 2009 we
reduced the salary of the highly compensated employees to meet our economic
challenges and our cash flow needs. In addition, from time to time,
we are unable to make payroll due to our lack of cash.
We
depend upon our senior management and key consultants and their loss or
unavailability could put us at a competitive disadvantage.
We depend
upon the efforts and abilities of our senior executives, as well as the services
of several key consultants, including Yvonne Paterson, Ph.D. The loss
or unavailability of the services of any of these individuals for any
significant period of time could have a material adverse effect on our business,
prospects, financial condition and results of operations. We have not
obtained, do not own, nor are we the beneficiary of, key-person life
insurance.
Risks
Related to the Biotechnology / Biopharmaceutical Industry
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. We may
be unable to compete with more substantial enterprises.
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of
competition. Competition in the biopharmaceutical industry is based
significantly on scientific and technological factors. These factors
include the availability of patent and other protection for technology and
products, the ability to commercialize technological developments and the
ability to obtain governmental approval for testing, manufacturing and
marketing. We compete with specialized biopharmaceutical firms in the
U.S., Europe and elsewhere, as well as a growing number of large pharmaceutical
companies that are applying biotechnology to their operations. Many
biopharmaceutical companies have focused their development efforts in the human
therapeutics area, including cancer. Many major pharmaceutical
companies have developed or acquired internal biotechnology capabilities or made
commercial arrangements with other biopharmaceutical companies. These
companies, as well as academic institutions and governmental agencies and
private research organizations, also compete with us in recruiting and retaining
highly qualified scientific personnel and consultants. Our ability to
compete successfully with other companies in the pharmaceutical field will also
depend to a considerable degree on the continuing availability of capital to
us.
We are
aware of certain products under development or manufactured by competitors that
are used for the prevention, diagnosis, or treatment of certain diseases we have
targeted for product development. Various companies are developing
biopharmaceutical products that potentially directly compete with our product
candidates even though their approach to such treatment is
different. Several companies, such as Anza Therapeutics, Inc in
particular, as well as Cell Genesys Inc., Antigenics, Inc., Avi BioPharma, Inc.,
Biomira, Inc., Biovest International, Dendreon Corporation, Pharmexa-Epimmune,
Inc., Genzyme Corp., Progenics Pharmaceuticals, Inc., Vical
Incorporated, and other firms with more resources than we have are
currently developing or testing immune therapeutic agents in the same
indications we are targeting.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector with a superior technology that is both safer
and more effective than our competitors. Our competition will be
determined in part by the potential indications for which drugs are developed
and ultimately approved by regulatory authorities. Additionally, the
timing of market introduction of some of our potential products or of
competitors’ products may be an important competitive
factor. Accordingly, the relative speed with which we can develop
products, complete preclinical testing, clinical trials and approval processes
and supply commercial quantities to market is expected to be important
competitive factors. We expect that competition among products
approved for sale will be based on various factors, including product efficacy,
safety, reliability, availability, price and patent position.
Risks
Related to the Securities Markets and Investments in our Common
Stock
The
price of our common stock may be volatile.
The
trading price of our common stock may fluctuate substantially. The
price of our common stock that will prevail in the market after the sale of the
shares of common stock by the selling stockholders may be higher or lower than
the price you have paid, depending on many factors, some of which are beyond our
control and may not be related to our operating performance. These
fluctuations could cause you to lose part or all of your investment in our
common stock. Those factors that could cause fluctuations include,
but are not limited to, the following:
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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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In the
past, following periods of volatility in the market price of a company’s
securities, securities class action litigation has often been brought against
that company. Due to the potential volatility of our stock price, we
may therefore be the target of securities litigation in the
future. Securities litigation could result in substantial costs and
divert management’s attention and resources from our business.
You
may have difficulty selling our shares because they are deemed “penny
stocks.”
Our
common stock is deemed to be “penny stock” as that term is defined in Rule
3a51-1, promulgated under the Exchange Act. Penny stocks are,
generally, stocks:
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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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Section
15(g) of the Exchange Act and Rule 15g-2 promulgated thereunder require
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document before effecting any transaction in a
“penny stock” for the investor’s account. We urge potential investors
to obtain and read this disclosure carefully before purchasing any shares that
are deemed to be “penny stock.”
Rule
15g-9 promulgated under the Exchange Act requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any “penny stock” to that investor. This procedure requires
the broker-dealer to:
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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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Compliance
with these requirements may make it harder for investors in our common stock to
resell their shares to third parties. Accordingly, our common stock
should only be purchased by investors, who understand that such investment is a
long-term and illiquid investment, and are capable of and prepared to bear the
risk of holding our common stock for an indefinite period of
time.
A
limited public trading market may cause volatility in the price of our common
stock.
Our
common stock began trading on the OTC Bulletin Board on July 28, 2005 and is
quoted under the symbol ADXS.OB. The quotation of our common stock on
the OTC Bulletin Board does not assure that a meaningful, consistent and liquid
trading market currently exists, and in recent years such market has experienced
extreme price and volume fluctuations that have particularly affected the market
prices of many smaller companies like us. Our common stock is thus
subject to this volatility. Sales of substantial amounts of common
stock, or the perception that such sales might occur, could adversely affect
prevailing market prices of our common stock and our stock price may decline
substantially in a short time and our stockholders could suffer losses or be
unable to liquidate their holdings. Also there are large blocks of
restricted stock that have met the holding requirements under Rule 144 that can
be unrestricted and sold. Our stock is thinly traded due to the
limited number of shares available for trading on the market thus causing large
swings in price.
There
is no assurance of an established public trading market.
A regular
trading market for our common stock may not be sustained in the
future. The effect on the OTC Bulletin Board of these rule changes
and other proposed changes cannot be determined at this time. The OTC
Bulletin Board is an inter-dealer, over-the-counter market that provides
significantly less liquidity than the Nasdaq Stock Market. Quotes for
stocks included on the OTC Bulletin Board are not listed in the financial
sections of newspapers. As such, investors and potential investors may find it
difficult to obtain accurate stock price quotations, and holders of our common
stock may be unable to resell their securities at or near their original
offering price or at any price. Market prices for our common stock
will be influenced by a number of factors, including:
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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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We
may not be able to achieve secondary trading of our stock in certain states
because our common stock is not nationally traded.
Because
our common stock is not listed for trading on a national securities exchange,
our common stock is subject to the securities laws of the various states and
jurisdictions of the U.S. in addition to federal securities law. This
regulation covers any primary offering we might attempt and all secondary
trading by our stockholders. If we fail to take appropriate steps to
register our common stock or qualify for exemptions for our common stock in
certain states or jurisdictions of the U.S., the investors in those
jurisdictions where we have not taken such steps may not be allowed to purchase
our stock or those who presently hold our stock may not be able to resell their
shares without substantial effort and expense. These restrictions and
potential costs could be significant burdens on our
stockholders.
If
we fail to remain current on our reporting requirements, we could be removed
from the OTC Bulletin Board, which would limit the ability of broker-dealers to
sell our securities and the ability of stockholders to sell their securities in
the secondary market.
Companies
trading on the OTC Bulletin Board, such as us, must be reporting issuers under
Section 12 of the Exchange Act, as amended, and must be current in their reports
under Section 13, in order to maintain price quotation privileges on the OTC
Bulletin Board. For our third quarter 2009 we were unable to file our
quarterly report on Form 10-Q in a timely manner, but we were able to make the
filing and cure our compliance deficiency with the OTC Bulletin Board within the
grace period allowed by the OTC Bulletin Board. If we fail to remain
current on our reporting requirements, we could be removed from the OTC Bulletin
Board. As a result, the market liquidity for our securities could be
severely adversely affected by limiting the ability of broker-dealers to sell
our securities and the ability of stockholders to sell their securities in the
secondary market.
Our internal
control over financial reporting and our disclosure controls and procedures have
been ineffective, and failure to improve them could lead to errors in our
financial statements that could require a restatement or untimely filings, which
could cause investors to lose confidence in our reported financial information,
and a decline in our stock price.
Our chief
executive officer and chief financial officer, after evaluating the
effectiveness of our “disclosure controls and procedures”, as defined in the
Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e), as of the end of
the three month period ended July 31, 2009, concluded that as of July 31, 2009,
our internal controls over financial reporting were not effective to provide
reasonable assurance that information required to be disclosed in our reports
filed or submitted under the Securities Exchange Act of 1934 is recorded,
processed, summarized and reported within the time periods specified by the SEC,
and that material information relating to our company is made known to
management, including chief executive officer and chief financial officer,
particularly during the period when our periodic reports are being prepared, to
allow timely decisions regarding required disclosure.
In
addition, our management assessed the effectiveness of our internal control over
financial reporting as of July 31, 2009 on criteria for effective internal
control over financial reporting described in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this evaluation, management has determined that
as of July 31, 2009, there were material weaknesses in our internal control over
financial reporting. During the review of the financial statements
for the three month period ended July 31, 2009, it was determined that our
initial presentation and accounting of certain of our convertible debt and
warrants in our financial statements was not correct. In light of this material
weakness, we concluded that we did not maintain effective internal control over
financial reporting as of July 31, 2009. Our management is
responsible for establishing and maintaining adequate internal control over
financial reporting for us. As defined by the Public Company
Accounting Oversight Board Auditing Standard No. 5, a material weakness is a
deficiency or a combination of deficiencies, such that there is a reasonable
possibility that a material misstatement of the annual or interim financial
statements will not be prevented or detected. We
revised our financial statements for the three month period ended July 31, 2009,
prior to filing our quarterly report on Form 10-Q for the period ended July 31,
2009, but cannot offer assurances that we will not have additional material
weaknesses. While we have taken steps to improve our internal
controls and procedures, there may continue to be material weaknesses or
deficiencies in our internal controls or ineffectiveness of our disclosure
controls and procedures. As a
result of the material weakness in our internal controls and the ineffectiveness
of our disclosure controls and procedures as of July 31, 2009, current and
potential stockholders could lose confidence in our financial reporting, which
would harm our business and the trading price of our stock.
We
may be exposed to potential risks resulting from new requirements under
Section 404 of the Sarbanes-Oxley Act of 2002.
Pursuant
to Section 404 of the Sarbanes-Oxley Act of 2002, beginning with our fiscal year
ended October 31, 2008, we are required to include in our annual report our
assessment of the effectiveness of our internal control over financial
reporting. Furthermore, beginning with our fiscal year ending October
31, 2010, our independent registered public accounting firm will be required to
attest to whether our assessment of the effectiveness of our internal control
over financial reporting is fairly stated in all material respects and
separately report on whether it believes we have maintained, in all material
respects, effective internal control over financial reporting for our fiscal
year then ending and for each fiscal year thereafter. Although we
have completed our assessment of the effectiveness of our internal control over
financial reporting, we expect to incur additional expenses and diversion of
management’s time as a result of performing the system and process evaluation,
testing and remediation required in order for us and our auditors to comply with
the auditor attestation requirements.
Our
executive officers and directors can exert significant influence over us and may
make decisions that do not always coincide with the interests of other
stockholders.
Our
officers and directors, and their affiliates, in the aggregate, beneficially
own, as of October 1, 2009, 18.1% of the outstanding shares of our common
stock. As a result, such persons, acting together, have the ability
to substantially influence all matters submitted to our stockholders for
approval, including the election and removal of directors and any merger,
consolidation or sale of all or substantially all of our assets, and to control
our management and affairs. Accordingly, such concentration of
ownership may have the effect of delaying, deferring or preventing a change in
or discouraging a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our business, even if such a transaction would
be beneficial to other stockholders.
Sales
of additional equity securities may adversely affect the market price of our
common stock and your rights in us may be reduced.
We expect
to continue to incur product development and selling, general and administrative
costs, and to satisfy our funding requirements, we will need to sell additional
equity securities, which may be subject to registration rights and warrants with
anti-dilutive protective provisions. The sale or the proposed sale of
substantial amounts of our common stock in the public markets may adversely
affect the market price of our common stock and our stock price may decline
substantially. Our stockholders may experience substantial dilution
and a reduction in the price that they are able to obtain upon sale of their
shares. Also, new equity securities issued may have greater rights,
preferences or privileges than our existing common stock.
Additional
authorized shares of common stock available for issuance may adversely affect
the market.
We are
authorized to issue 500,000,000 shares of our common stock. As of
October 1, 2009, we had 115,638,243 shares of our common stock issued and
outstanding, excluding shares issuable upon exercise of our outstanding warrants
and options. As of July 31, 2009, we had outstanding options to
purchase 17,962,841 shares of our common stock at a weighted exercise price of
$0.16 per share and outstanding warrants to purchase 89,143,801 shares of our
common stock, with exercise prices ranging from $0.18 to $0.29 per
share. Pursuant to our 2004 Stock Option Plan, 2,381,525 shares of
common stock are reserved for issuance under the plan. Pursuant to
our 2005 Stock Option Plan, 5,600,000 shares of common stock are reserved for
issuance under the plan. As of October 1, 2009, the 2004 Stock Option Plan
and the 2005 Stock Option Plan have an aggregate of 170,083 shares of common
stock available for issuance. In addition, we have granted 11,151,399
options as non-plan options. To the extent the shares of common stock
are issued or options and warrants are exercised, holders of our common stock
will experience dilution. In addition, in the event of any future
financing of equity securities or securities convertible into or exchangeable
for, common stock, holders of our common stock may experience
dilution.
Shares
eligible for future sale may adversely affect the market.
Sales of
a significant number of shares of our common stock in the public market could
harm the market price of our common stock. This prospectus covers
80,671,250 shares of common stock issuable upon exercise of our outstanding
warrants, which represents approximately 36% of our outstanding shares of our
common stock as of October 1, 2009 on a fully diluted basis. As
additional shares of our common stock become available for resale in the public
market pursuant to this offering, and otherwise, the supply of our common stock
will increase, which could decrease its price. Some or all of the
shares of common stock may be offered from time to time in the open market
pursuant to Rule 144, and these sales may have a depressive effect on the market
for our shares of common stock. In general, under Rule 144 as
currently in effect, a non-affiliate of ours who has beneficially owned shares
of our common stock for at least six months is entitled to sell his or her
shares without any volume limitations, and an affiliate of ours can sell such
number of shares within any three-month period as does not exceed the greater of
1% of the number of shares of our common stock then outstanding, which equaled
1,156,382 shares as of October 1, 2009, 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. Sales under Rule 144 by our affiliates are also subject to
manner-of-sale provisions, notice requirements and the availability of current
public information about us.
We
are able to issue shares of preferred stock with rights superior to those of
holders of our common stock. Such issuances can dilute the tangible
net book value of shares of our common stock.
Our
Certification of Incorporation provides for the authorization of 5,000,000
shares of “blank check” preferred stock. Pursuant to our Certificate
of Incorporation, our board of directors is authorized to issue such “blank
check” preferred stock with rights that are superior to the rights of
stockholders of our common stock, at a purchase price then approved by our board
of directors, which purchase price may be substantially lower than the market
price of shares of our common stock, without stockholder
approval. Such issuances can dilute the tangible net book value of
shares of our common stock.
We
do not intend to pay dividends.
We have
never declared or paid any dividends on our securities. We currently
intend to retain our earnings for funding growth and, therefore, do not expect
to pay any dividends in the foreseeable future.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus contains forward-looking statements. We have based these
forward-looking statements on our current expectations and projections about
future events. These statements include, but are not limited
to:
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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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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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These
statements may be found in the sections of this prospectus titled “Prospectus
Summary,” “Risk Factors,” “Management’s Discussion and Analysis and Results of
Operations,” and “Description of our Business,” as well as in this prospectus
generally. Actual results could differ materially from those
anticipated in these forward-looking statements as a result of various factors,
including all the risks discussed in “Risk Factors” and elsewhere in this
prospectus.
In
addition, statements that use the terms “can,” “continue,” “could,” “may,”
“potential,” “predicts,” “should,” “will,” “believe,” “expect,” “plan,”
“intend,” “estimate,” “anticipate,” “scheduled” and similar expressions are
intended to identify forward-looking statements. All forward-looking
statements in this prospectus reflect our current views about future events and
are based on assumptions and are subject to risks and uncertainties that could
cause our actual results to differ materially from future results expressed or
implied by the forward-looking statements. Many of these factors are
beyond our ability to control or predict. Forward-looking statements
do not guarantee future performance and involve risks and
uncertainties. Actual results will differ, and may differ materially,
from projected results as a result of certain risks and
uncertainties. The risks and uncertainties include, without
limitation, those described under “Risk Factors” and those detailed from time to
time in our filings with the SEC, and include, among others, the
following:
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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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These
risks are not exhaustive. Other sections of this prospectus may
include additional factors which could adversely impact our business and
financial performance. Moreover, we operate in a very competitive and
rapidly changing environment. New risk factors emerge from time to
time and it is not possible for our management to predict all risk factors, nor
can we assess the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements. Given these risks and uncertainties, investors should not
place undue reliance on forward-looking statements as a prediction of actual
results. These forward-looking statements are made only as of the
date of this prospectus. Except for our ongoing obligation to
disclose material information as required by federal securities laws, we do not
intend to update you concerning any future revisions to any forward-looking
statements to reflect events or circumstances occurring after the date of this
prospectus.
USE
OF PROCEEDS
Other
than the cash exercise prices of the warrants, we will not receive any proceeds
from the sale of shares of common stock covered by this prospectus by the
selling stockholders. If all such warrants covered by this prospectus
are exercised for cash, we will receive gross proceeds of approximately
$16,134,250. We intend to use such proceeds for working capital and
general corporate purposes. No assurance can be given, however, as to
when, if ever, any or all of such warrants will be exercised.
MARKET
PRICE OF AND DIVIDENDS ON OUR COMMON STOCK
AND
RELATED STOCKHOLDER MATTERS
Since
July 28, 2005, our common stock has been quoted on the OTC Bulletin Board under
the symbol ADXS.OB. The following table shows, for the periods
indicated, the high and low bid prices per share of our common stock as reported
by the OTC Bulletin Board. These bid prices represent prices quoted
by broker-dealers on the OTC Bulletin Board. The quotations reflect
inter-dealer prices, without retail mark-up, mark-down or commissions, and may
not represent actual transactions.
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Fiscal 2009
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Fiscal 2008
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Fiscal 2007
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High
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Low
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High
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Low
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High
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Low
|
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First
Quarter (November 1-January 31)
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$ |
0.06 |
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|
$ |
0.01 |
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|
$ |
0.20 |
|
|
$ |
0.13 |
|
|
$ |
0.21 |
|
|
$ |
0.14 |
|
Second
Quarter (February 1- April 30)
|
|
$ |
0.05 |
|
|
$ |
0.02 |
|
|
$ |
0.15 |
|
|
$ |
0.09 |
|
|
$ |
0.54 |
|
|
$ |
0.15 |
|
Third
Quarter (May 1 - July 31)
|
|
$ |
0.21 |
|
|
$ |
0.04 |
|
|
$ |
0.135 |
|
|
$ |
0.058 |
|
|
$ |
0.36 |
|
|
$ |
0.24 |
|
Fourth
Quarter (August 1 - October 31)
|
|
$ |
0.19 |
|
|
$ |
0.06 |
|
|
$ |
0.07 |
|
|
$ |
0.03 |
|
|
$ |
0.27 |
|
|
$ |
0.10 |
|
__________________________
As
of October 1, 2009, there were approximately 100
stockholders of record. Because
shares of our common stock are held by depositaries, brokers and other nominees,
the number of beneficial holders of our shares is substantially larger than the
number of stockholders of record. Based on information available to us, we
believe there are approximately 1,700 non-objecting beneficial owners of our
shares of our common stock in addition to the stockholders of record. On
November 3, 2009, the last reported sale price per share for our common stock as
reported by the OTC Bulletin Board was $0.12.
We have
not declared or paid any cash dividends on our common stock, and we do not
anticipate declaring or paying cash dividends for the foreseeable future. We are
not subject to any legal restrictions respecting the payment of dividends,
except that we may not pay dividends if the payment would render us
insolvent. Any future determination as to the payment of dividends on
our common stock will be at our board of directors’ discretion and will depend
on our financial condition, operating results, capital requirements and other
factors that our board of directors considers to be relevant.
Holders
of Series A preferred stock will be entitled to receive dividends, which will
accrue in shares of Series A preferred stock on an annual basis at a rate equal
to 10% per annum from the issuance date. Accrued dividends will be payable upon
redemption of the Series A preferred stock. The Series A preferred stock ranks,
with respect to dividend rights and rights upon liquidation:
|
·
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senior
to our common stock; and
|
|
·
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junior
to all of our existing and future
indebtedness.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
This
Management’s Discussion and Analysis of Financial Conditions and Results of
Operations and other portions of this prospectus contain forward-looking
information that involves risks and uncertainties. Our actual results
could differ materially from those anticipated by the forward-looking
information. Factors that may cause such differences include, but are
not limited to, availability and cost of financial resources, product demand,
market acceptance and other factors discussed in this prospectus under the
heading “Risk Factors”. This Management’s Discussion and Analysis of
Financial Conditions and Results of Operations should be read in
conjunction with our financial statements and the related notes included
elsewhere in this prospectus.
Overview
Advaxis
is a development stage biotechnology company with the intent to develop safe and
effective cancer vaccines that utilize multiple mechanisms of immunity. We are
developing a live Listeria vaccine technology
under license from Penn which can be engineered to secrete a variety of
different protein sequences containing tumor-specific antigens
leading to the development of a variety of different products. We believe this
vaccine technology is capable of stimulating the body’s immune system to process
and recognize the antigen that has a therapeutic effect upon cancer. We believe
that this to be a broadly enabling platform technology that can be applied to
the treatment of many types of cancers, infectious diseases and auto-immune
disorders.
The
discoveries that underlie this innovative technology are based upon the work of
Yvonne Paterson, Ph.D., Professor of Microbiology at Penn. This
technology involves the creation of genetically engineered Listeria that stimulate the
innate immune system and induce an antigen-specific immune response involving
both arms of the adaptive immune system. In addition, this technology
supports, among other things, the immune response by altering tumors to make
them more susceptible to immune attack, stimulating the development of specific
blood cells that underlie a strong therapeutic immune response.
We have
no customers. Since our inception in 2002, we have focused our
development efforts upon understanding our technology and establishing a product
development pipeline that incorporates this technology in the therapeutic cancer
vaccines area targeting cervical, prostate, breast, and a pre cancerous
indication of CIN. Although no products have been commercialized to date,
research and development and investment continues to be placed behind the
pipeline and the advancement of this technology. Pipeline development and the
further exploration of the technology for advancement entail risk and expense.
We anticipate that our ongoing operational costs will increase significantly
when we begin several of our clinical trials.
The
following factors, among others, could cause actual results to differ from those
indicated in the above forward-looking statements: increased length and scope of
our clinical trials, failure to recruit patients, increased costs related to
intellectual property related expenses, increased cost of manufacturing and
higher consulting costs. These factors or additional risks and uncertainties not
known to us or that we currently deem immaterial may impair business operations
and may cause our actual results to differ materially from any forward-looking
statement.
Although
we believe the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance
or achievements.
We expect
our future sources of liquidity to be primarily debt and equity capital raised
from investors, as well as licensing fees and milestone payments in the event we
enter into licensing agreements with third parties, and research collaboration
fees in the event we enter into research collaborations with third parties. Of
the grants applied for, there is $5,809,571 still outstanding, which could net
us up to $4,662,860 in funding strategic research (the award of one grant will
exclude us from receiving a similar one that we’ve applied for) and clinical
programs, excluding the NIH grant that we were awarded in August 2009. In
addition, we have applied for the New Jersey NOL program for our tax losses in
fiscal year 2008 as well as the Research Tax Credit Program for the first time
this year.
If
additional capital were raised through the sale of equity or convertible debt
securities, the issuance of such securities would result in additional dilution
to our existing stockholders. If we fail to raise a significant amount of
capital, we may need to significantly curtail operations or cease operations in
the near future. Any sale of our common stock at its current price
will trigger a significant dilution due to the ratchets in the warrant
agreements, debt agreements and the security purchase agreement for the October
17, 2007 raise.
Plan
of Operations
If we are
successful in our financing plans we intend to use a significant portion of the
proceeds currently under way to conduct our two Phase II trials using
ADXS11-001, our lead product candidate in development using our Listeria
System. One will be a U.S. study in CIN, the other, the other, an
Indian study in cervical cancer. We also anticipate using the funds to further
our pre-clinical and clinical, research and development efforts in developing
product candidates and to maintain our preclinical capabilities and strategic
activities. Our corporate staff will be responsible for the general
and administrative activities.
During
the next 24 months, our strategic focus will be to achieve the following goals
and objectives:
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·
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Raise
funding to pursue 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;
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·
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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;
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·
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Continue
to work on our grant from the NIH awarded in August 2009 for $210,000 to
develop a single bioengineered Listeria monocytogenes (Lm)
vaccine to deliver two different antigen-adjuvant
proteins.
|
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·
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Follow
up on the status of our grant applications with the NIH for $948,000 and
the U.S. Department of Defense Solicitation for up to $3.5
million.
|
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·
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Continue
to focus working with government funded or subsidized research in the U.S.
in the treatment of cervical
cancer;
|
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·
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Continue
to work with our strategic and development collaborations with academic
laboratories;
|
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·
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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;
|
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·
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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
|
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·
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Continue
the pre-clinical development of other product candidates, as well as
continue research to expand our technology
platform.
|
Our
projected annual staff, overhead and preclinical expenses are estimated to be
approximately $4.1 million starting in fiscal year beginning November 1,
2009. The cost of our Phase II clinical studies in therapeutic
treatment of CIN and late stage cancer of the cervix is estimated to be
approximately $8.0 million over the estimated 30 month period of the
trial. Therefore we must raise additional funds in order to fund the
entire Phase II CIN trial. Our Phase II ADXS11-001 clinical studies
are anticipated to commence in January 2010. If we can raise
additional funds we intend to commence the clinical work in prostate cancer by
late 2010 or beyond and breast cancer by 2011 or beyond. The
timing and estimated costs of these projects are difficult to predict and
depends on factors such as our ability to raise funds and enter into a corporate
partnership.
Overall,
given the development stage of our business, our financial needs are driven, in
large part, by the progress of our clinical trials and those of the GOG as well
as preclinical programs. The cost of these clinical trial projects is
significant. As a result, we will are currently attempting
to raise additional debt or equity now and in the future. If the
clinical progress continues to be successful and the value of our company
increases, we may attempt to accelerate the timing of the required financing
and, conversely if the trial or trials are not successful we may slow our
spending and the timing of additional financing will be
deferred. While we will attempt to attract a corporate partnership
and grants, we have not assumed the receipt of any additional financial
resources in our cash planning.
We
anticipate that our research and development expenses will increase
significantly as a result of our expanded development and commercialization
efforts related to clinical trials, product development, and development of
strategic and other relationships required ultimately for the licensing,
manufacture and distribution of our product candidates. We regard
three of our product candidates as major research and development
projects. The timing, costs and uncertainties of those projects are
as follows:
ADXS11-001 - Phase II CIN
Trial Summary Information (U.S. 80 Patients)
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·
|
Cost
incurred to date: approximately $1.1
million
|
|
·
|
Estimated
future clinical costs: $5.7 million to $6.0
million
|
|
·
|
Anticipated
Timing: start January 2010; completion August 2012 or
beyond
|
Uncertainties:
|
·
|
The
FDA (or relevant foreign regulatory authority) may place the project on
clinical hold or stop the project;
|
|
·
|
One
or more serious adverse events in otherwise healthy patients enrolled in
the trial;
|
|
·
|
Difficulty
in recruiting patients;
|
|
·
|
Material
cash flows; and
|
|
·
|
Anticipated
Timing: Unknown at this stage and dependent upon successful trials,
adequate fund raising, entering a licensing deal or pursuant to a
marketing collaboration subject to regulatory approval to market and sell
the product.
|
ADXS11-001 - Phase II Cancer
of the Cervix Trial Summary Information (India: 110
Patients)
|
·
|
Cost
incurred to date: approximately
$101,650
|
|
·
|
Estimated
future clinical costs: $2.1 million to $2.3
million
|
|
·
|
Anticipated
Timing: start January 2010; completion August 2012 or
beyond
|
Additional
Uncertainties:
|
·
|
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.
|
ADXS11-001 - Phase II Cancer
of the Cervix Trial Summary Information (U.S. GOG/NCI: 63
Patients)
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·
|
Cost
incurred to date: less than $10,000
|
|
·
|
Estimated
future clinical costs: $500,000 (Government absorbed cost $2.5 million to
$3.0 million)
|
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·
|
Anticipated
Timing: to be determined
|
Additional
Uncertainties:
|
·
|
Unknown
timing in recruiting patients and conducting the study based on GOG/NCI
controlled study;
|
|
·
|
Delays
in the program; and
|
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·
|
Given
the economic environment the trial may not get
funded.
|
ADXS31-142 - Pre Clinical
and Phase I Trial Summary Information (TBD Prostate Cancer 30
Patients)
|
·
|
Cost
incurred to date: approximately
$200,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
Additional
Uncertainties:
|
·
|
FDA
(or foreign regulatory authority) may not approve the
study.
|
ADXS31-164 - Phase I trial
Summary Information (TBD Breast Cancer 24 Patients)
|
·
|
Cost
incurred to date: $450,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
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Anticipated
Timing: to be determined
|
Additional Uncertainties:
See ADXS31-164 (see prior Uncertainties)
Nine
months ended July 31, 2009 period compared to the nine months ended July 31,
2008
Revenue. Our revenue
decreased by $73,773, or over 100%, to a negative $5,369 for the nine months
ended July 31, 2009 (“Fiscal 2009 Period”) as compared with $68,404 for the nine
months ended July 31, 2008 (“Fiscal 2008 Period”) due to a grant from the
State of New Jersey received in the Fiscal 2008 Quarter not being repeated in
Fiscal 2009 Quarter combined with the State request to refund certain grant
money received on a prior grant.
Research and Development
Expenses. Research and development expenses decreased by $1,042,126 or
52%, to $962,198 for the Fiscal 2009 Period as compared with $2,004,324 for the
Fiscal 2008 Period, principally attributable to the following:
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·
|
Clinical
trial expenses decreased by $187,512, or 67%, to $94,013 from $281,525
primarily due to the close out of our Phase I trial in the Fiscal
2008 Period which more than off set the one-half month of start-up cost of
our Phase II cervical cancer study in India in the Fiscal 2009
Period.
|
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·
|
Wages,
options and lab costs decreased by $171,571 or 19% to $718,850 from
$888,212 principally due to the recording of the full years bonus accrual
in Fiscal 2008 that was reversed in Fiscal 2009 Period or $242,385. No
bonus accrual was recorded nor paid in Fiscal 2009 Period. Overall the lab
costs were lower due to the priority given to the lower cost of grant and
publication writing. These lower costs were partially offset by $107,624
higher option expense relating to new grants in Fiscal 2009 Period and
$40,930 in wages primarily due to the new hire of the Executive Director,
Product Development in March
2008.
|
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·
|
Consulting
expenses increased by $11,829, or 12%, to $107,709 from $95,880,
principally due to higher option expense of $30,835 recorded in Fiscal
2009 Period relating to new grants as compared to a credit to option
expense of $36,922 due to the true up of unvested option expense recorded
in prior Fiscal periods. This resulted in a $67,757 increase, overall, of
option expense which was offset in part by the lower effort required to
prepare the IND filing for the FDA or $56,928 in the Fiscal 2009 Period
compared to the same period last
year.
|
|
·
|
Subcontracted
research expenses decreased by $121,023, or 100%, to $0 from $121,023
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 $547,208, to $41,626 from $588,834, or 93% resulting
from the completion of our clinical supply program for the upcoming CIN
trial prior to Fiscal 2009 Period compared to the manufacturing program in
the Fiscal 2008.
|
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·
|
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.
|
General and Administrative
Expenses. General and administrative expenses decreased by $308,424, or
13%, to $2,041,016 for the Fiscal 2009 Period as compared with $2,349,439 for
the Fiscal 2008 Period primarily attributable to the following:
|
·
|
Wages,
Options and benefit expenses decreased by $113,876, or 12% to $828,290
from $942,166 principally due to the reversal of a nine month bonus
accrual in Fiscal 2009 Period or $79,039 that was recorded as expense in
Fiscal 2008 Period (no bonus accrual was recorded nor paid in Fiscal 2009
Period) and no stock was issued in Fiscal 2009 Period compared to $71,250
worth of stock was issued to the CEO per his employment agreement in
Fiscal 2008 Period. These lower expenses were partially offset
by higher option expense of $45,975 primarily due to new stock options
granted in Fiscal 2009 Period resulting in a $105,112 expense partially
offset by lower option expenses recorded in Fiscal 2009 Period due to the
nine months vesting of the CEO’s options in Fiscal 2008 Period compared to
two months of vesting of his options in the Fiscal 2009
Period.
|
|
·
|
Consulting
fees decreased by $272,769, or 73%, to $99,150 from $371,919. This
decrease was primarily attributed to a one-time payment in settlement of
Mr. Appel’s (our previous President & CEO) employment agreement of
$130,000 recorded in the Fiscal 2008 Period. The consulting expenses
were also $180,571 lower due to reduced financial advisor fees in Fiscal
2009 Period compared to $200,571 recorded in the Fiscal 2008 Period
primarily due to the close of the offering on October 17, 2007. These
lower fees were partially offset by $50,000 fees recorded for the Sage
Group in Fiscal 2009 Period for seeking corporate partnerships that did
not occur in Fiscal 2008 Period.
|
|
·
|
Offering
expenses increased by $302,505 to $335,633 from $33,128. The offering
expenses of $351,973 recorded included in Fiscal 2009 Period or an
increase of $318,845 consists of legal costs in preparation for financial
raises and SEC filings that did not occur in Fiscal 2008 Period, partially
offset by non-cash warrants
expense.
|
|
·
|
An
increase in legal, accounting, professional and public relations expenses
of $77,121, or 18%, to $516,521 from $439,400, primarily as a result of a
higher overall legal, patent expenses of $114,049 partially offset by
lower accounting, Public relations and tax preparation fees in Fiscal 2009
Period than in the Fiscal 2008
Period.
|
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $3,090, or
4%, to $81,860 from $78,770 primarily due to an increase in fixed assets
and intangibles in the Fiscal 2009 Period compared to the Fiscal 2008
Period.
|
|
·
|
Analysis
Research cost decreased by $117,990 or 100%, to $0 from $117,990 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 $123,110 or 41% to
$179,561 from $302,672. Conference and dues and subscription expenses have
decreased by $89,044 in the Fiscal 2009 Period due to lower participation
in cancer conferences. In addition lower travel related to the reduced
conferences attendance amounted to a decrease of $21,061 in the Fiscal
2009 Period than incurred in Fiscal 2008
Period.
|
Other Income (expense). Other
income increased by $1,562,883 to $1,603,605 in income for Fiscal 2009 Period
from income of $40,722 for the Fiscal 2008 Period. In Fiscal Period 2009
the Net change in fair value of common stock warrant liability and embedded
liability resulted in income of $2,014,220 due to a lower fair market value on
July 31, 2009 compared to June 18, 2009, while this transaction did not incur in
Fiscal Period 2008. During the Fiscal 2009 and the Fiscal 2008
Periods, we recorded interest expense of $410,615 and $5,705, respectively,
primarily related to interest accrued on our outstanding notes including
accreted interest on the of $316,623 on the value of the warrant and embedded
derivative liabilities. Interest earned on investments for the Fiscal 2009 and
Fiscal 2008 Periods amounted to $0 and $46,427, respectively
Income Tax . In the
Fiscal 2009 Period there was a net change of $922,020 recorded due to a gain
recorded from the receipt of a NOL tax credit received from the State of New
Jersey tax program. There was no comparable gain in Fiscal 2008 Period as this
was the first year we were awarded this NOL credit.
We
anticipate an increase in Research and Development expenses as a result of
expanded development and commercialization efforts related to clinical trials,
and product development, and expenses to be incurred in the development of
strategic and other relationships required ultimately if the licensing,
manufacture and distribution of our product candidates are
undertaken.
Fiscal
Year 2008 Compared to Fiscal Year 2007
Revenue. Our
revenue decreased by $88,465, or 57%, from $154,201 during the fiscal 2007
period to $65,736 as compared with the fiscal 2008 period primarily due to
the decreased grant money of $133,850 received from the NCI in the fiscal
2007 period not repeated in the fiscal 2008 period partially offset by the
increased grant money received from the State of New Jersey in the fiscal 2008
period as compared to the fiscal 2007 period.
Research and Development
Expenses. Research and development expenses increased by
$353,744, or 17%, from $2,128,096 for the fiscal 2007 period to $2,481,840 for
the fiscal 2008 period, principally attributable to the following:
Clinical
trial expenses decreased by $117,014, or 29%, from $401,783 to $284,769 due to
our higher clinical trial activity in the fiscal 2007 period compared to the
close out phase in the fiscal 2008 period.
Wages,
options and lab costs increased by $309,756, or 37%, from $832,757 to $1,142,513
principally due to our expanded research & development efforts, the hiring
of an Executive Director of Product Development, a wage increase on November 1,
2007 and an increase in bonuses.
IND
development consulting expenses increased by $7,512 or 4%, from $174,960 to
$182,472 primarily due to the submission cost of our IND in Fiscal 2008 period
compared to Fiscal period 2007.
Subcontracted
research expenses decreased by $128,062, or 43%, from $300,535 to $172,473
primarily reflecting the decreased subcontract work performed by Dr. Paterson at
Penn, pursuant to our sponsored research agreement in the fiscal 2008 period
compared to the same period last year.
Manufacturing
expenses increased by $319,194 or 90%, from $353,780 to $672,974 as a result of
the ongoing clinical supply program for our upcoming Phase II trial in fiscal
2008 period compared to the manufacturing program in the fiscal 2007
period.
Toxicology
study expenses decreased by $37,640, or 59%, from $64,280 to $26,640 due to
expenses incurred in the fiscal 2007 period as a result of a toxicology study by
Pharm Olam in connection with our ADXS11-001 product candidates in anticipation
of clinical studies in 2008.
We
anticipate a continued increase in research and development expenses as a result
of the start-up of our Phase II CIN trial and other
costs. Additionally, we expect expenses to be incurred in the
development of strategic and other relationships required if the licensing,
manufacture and distribution of our product candidates are ultimately
undertaken.
General and Administrative
Expenses. General and administrative expenses increased by
$406,586, or 15%, from $2,629,094 for the fiscal 2007 period to $3,035,680 for
the fiscal 2008 period, primarily attributable to the
following:
Wages,
Options and benefit expenses increased by $369,991, or 44%, from $835,935 to
$1,205,926 primarily due to the increase of our Chief Executive Officer’s base
pay by $100,000 and stock compensation of $71,250 per his employment agreement,
overall higher wages of $47,000 for employees, increased board compensation of
$45,000 and benefits due to a wage increase on November 1, 2007.
Consulting
fees and expenses decreased by $370,618, or 46%, from $798,536 to
$427,918. This decrease was primarily attributed to an amendment to
Mr. Appel’s (LVEP) consulting agreement in the fiscal 2007 period partially
offset by a settlement agreement in the fiscal 2008 period which resulted in:
(i) a decrease of $251,269 in option expense recorded primarily due to an
amendment of Mr. Appel’s consulting agreement compared to no option expense
recorded in the fiscal 2008 period; (ii) a decrease of $200,000 primarily due to
the issuance to Mr. Appel of two million shares in the fiscal 2007 period also
due to the amendment, (iii) a net decrease of $256,747 in Mr. Appel’s consulting
expenses recorded in the fiscal 2008 period compared to the fiscal 2007 period
and (iv) a decrease of $41,667 in Mr. Appel’s bonus accrual in the fiscal 2007
period partially offset by (v) his $130,000 settlement payment in cash in the
fiscal 2008 period along with a $14,615 payment in shares of our common
stock. Mr. Appel’s net decreases (i-v) were partially offset by the
increase in other consulting expenses due to higher financial advisor fees of
$234,450 recorded in the fiscal 2008 periods versus the fees for other
consultants in the fiscal 2007 period.
Legal,
accounting, professional, tax preparation and public relations expenses
increased by $46,555, or 9%, from $517,810 to $564,365, primarily as a result of
higher patent, tax preparation and accounting expenses partially offset by lower
legal and public relations costs due to fewer security filings in the fiscal
2008 period versus the fiscal 2007 period.
Recruiting
fees for the Executive Director of Product Development increased by $62,295 from
$1,100 in the fiscal 2007 period to $63,395 in the fiscal 2008
period.
Analyst
research cost increased by $101,708 from $240 in fiscal 2007 period to $101,948
in fiscal 2008 period. This increase primarily consists of $55,240 in
warrant expense recorded based on the Black-Scholes calculation with the balance
in cost for fees, cash payment of $40,000 and printing expense.
Offering
expense increased by $49,744 from $3,774 to $53,518 due primarily to penalty
expense of $31,778 paid in our common stock recorded during the fiscal 2008
period due to the delay of effectiveness of the registration statement on Form
SB-2, File No. 333-147752.
Overall
costs for occupancy, dues, subscriptions and travel in the fiscal 2008 period
increased by $26,718 or 11%, from $247,304 to $274,022 primarily due to
increased travel and related expense for scientific and investor conferences
compared to the fiscal 2007 period.
Amortization
of intangibles and depreciation of fixed assets increased by $111,256 or 129%,
from $86,089 to $197,345 primarily due to the companies decision to discontinue
our use of its Trademark and write-off if its intangible assets $91,453 and
increase in fixed assets and intangibles in the fiscal 2008 period compared to
the fiscal 2007 period.
Overall
conference expenses and investor conferences in fiscal 2008 period increased by
$8,938 or 6%, from $138,306 to $147,244.
Other Income
(expense). Other Income (expense) decreased by $2,113,170 from
income of $2,148,536 for the fiscal 2007 period to income of $35,366 income for
the fiscal 2008 period.
During
the years ended October 31, 2008 and 2007 we recorded interest expense $11,263
and $607,193, respectively. Interest expense, relates primarily to
our then outstanding secured convertible debenture commencing at the closing
dates of our Two Tranche Private Placement on February 2 and March 8, 2006
extinguished on October 17, 2007. During the years ended October 31,
2008 and 2007 we recorded interest income of $46,629 and $63,406, respectively,
earned on investments. During the years ended October 31, 2008 and
2007 we recorded changes due to the fair market value of common stock warrants
and embedded derivative as a $0 and $1,159,846 gain, respectively. As
of October 17, 2007, the extinguishment date, the changes due to the fair market
value of common stock warrants and embedded derivative was recorded as a
$1,159,846 gain. There were no gains or losses recorded as of October
31, 2008 due to the extinguishments in the fiscal 2007 period. Due to
the eliminations of the convertible debenture in the fiscal 2007 period, we also
recorded a gain on extinguishment of the Debenture of $1,212,510 in addition to
$319,967 gain on retirement of a note with Penn totaling
$1,532,477. There were no gains on retirement in the fiscal 2008
period.
Liquidity
and Capital Resources
Our
limited capital resources and operations to date have been funded primarily with
the proceeds from public and private equity and debt financings, NOL tax credit
and income earned on investments and grants. We have sustained losses
from operations in each fiscal year since our inception, and we expect losses to
continue for the indefinite future, due to the substantial investment in
research and development. As of October 31, 2008 and July 31, 2009,
we had an accumulated deficit of $17,533,044 and $17,971,843, respectively, and
shareholders’ deficiency of $839,311 and $13,639,132, respectively.
Based on
our currently available cash, we do not have adequate cash on hand to cover our
anticipated expenses for the next 12 months. If we
fail to raise a significant amount of capital, we may need to significantly
curtail or cease operations in the near future. These conditions have
caused our auditors to raise substantial doubt about our ability to continue as
a going concern. Consequently, the audit report prepared by our
independent public accounting firm relating to our financial statements for the
year ended October 31, 2008 included a going concern explanatory
paragraph.
Our
business will require substantial additional investment that we have not yet
secured, and our failure to raise capital and/or pursue partnering opportunities
will materially adversely affect our business, financial condition and results
of operations. We expect to spend substantial additional sums on the continued
administration and research and development of proprietary products and
technologies, including conducting clinical trials for our product candidates,
with no certainty that our products will become commercially viable or
profitable as a result of these expenditures. Further, we will not
have sufficient resources to develop fully any new products or technologies
unless we are able to raise substantial additional financing on acceptable terms
or secure funds from new partners. We cannot be assured that financing will be
available at all. Any additional investments or resources required would be
approached, to the extent appropriate in the circumstances, in an incremental
fashion to attempt to cause minimal disruption or dilution. Any
additional capital raised through the sale of equity or convertible debt
securities will result in dilution to our existing stockholders. No
assurances can be given, however, that we will be able to achieve these goals or
that we will be able to continue as a going concern.
Pursuant
to the Optimus purchase agreement, Optimus has agreed to purchase, upon the
terms and subject to the conditions set forth therein and described below, up to
$5.0 million of our newly authorized, non-convertible, redeemable Series A
preferred stock at a price of $10,000 per share. Under the terms of the purchase
agreement, from time to time until September 24, 2012, in our sole discretion,
we may present Optimus with a notice to purchase a specified amount of Series A
preferred stock, which Optimus is obligated to purchase on the 10th trading day
after the date of the notice, subject to satisfaction of certain closing
conditions (including our ability to effect and maintain an effective
registration statement for the shares underlying the warrant to purchase
33,750,000 shares of common stock, issued to an affiliate of Optimus in
connection with the transaction). We will determine, in our sole discretion, the
timing and amount of Series A preferred stock to be purchased by Optimus, and
may sell such shares in multiple tranches. Optimus will not be obligated to
purchase the Series A preferred stock upon our notice (i) in the event the
closing price of our common stock during the nine trading days following
delivery of our notice falls below 75% of the closing price on the trading day
prior to the date such notice is delivered to Optimus or (ii) to the extent such
purchase would result in Optimus and its affiliates beneficially owning more
than 9.99% of our outstanding common stock.
On June
18, 2009, we completed the June 2009 bridge financing. The June 2009
bridge financing was 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 adjustments upon the
occurrence of certain events. As of
November 3, 2009, we completed a private placement with certain accredited
investors pursuant to which we issued (i)
junior unsecured convertible promissory notes in the aggregate principal face
amount of $2,088,235, for an aggregate net purchase price of $1,775,000 and (ii)
warrants to purchase 4,437,500 shares of our common stock at an exercise price
of $0.20 per share, subject to adjustments upon the occurrence of certain
events.
Each
of the June 2009 bridge notes and October 2009 bridge notes were issued with an
original issue discount of 15% and are convertible into shares of our common
stock as described below. The June
2009 bridge notes mature on December 31, 2009. With
respect to the October 2009 bridge notes, $58,824 of the face amount matures on
the later of (i) March 31, 2010 and (ii) the repayment in full or conversion of
the June 2009 bridge notes (and any other senior indebtedness), and $2,029,412
of the face amount matures on the later of (i) April 30, 2010 and (ii)
the repayment in full or conversion of the June 2009 bridge notes (and any other
senior indebtedness). We may prepay the June 2009 bridge notes
and October 2009 bridge notes, in whole or in part, without penalty at any time
prior to the respective maturity date.
The
indebtedness represented by the October 2009 bridge notes is expressly
subordinate to our currently outstanding senior secured indebtedness (including
the June 2009 bridge notes), as well as any future senior indebtedness of any
kind. We will not make any payments to the holders of the October
2009 bridge notes until the earlier of the repayment in full or conversion of
the senior indebtedness.
Each of
the June 2009 bridge warrants and October 2009 bridge warrants may be exercised
on a cashless basis under certain circumstances.
In the
event we consummate an equity financing with aggregate gross proceeds of not
less than $2.0 million, which we refer to as a qualified equity financing, prior
to the second business day immediately preceding the maturity date of the June
2009 bridge notes or October 2009 bridge notes, as the case may be, then prior
to the respective maturity date, the holders will have the option to convert all
or a portion of the respective notes into the same securities sold in such
qualified equity financing at an effective per share conversion price equal to
90% of the per share purchase price of the securities issued in the qualified
equity financing. In the event we do not consummate a qualified
equity financing prior to the second business day immediately preceding the
respective maturity date, then the holders shall have the option to convert all
or a portion of the June 2009 bridge notes or October 2009 bridge notes, as the
case may be, into shares of common stock, at an effective per share conversion
price equal to 50% of the volume-weighted average price per share of our
common stock over the five consecutive trading days immediately preceding the
third business day prior to the maturity date. To the extent a holder
does not elect to convert its bridge notes as described above, the principal
amount of the bridge notes not so converted shall be payable in cash on the
respective maturity date.
In
connection with the June 2009 bridge financing, we entered into a Security
Agreement, dated as of June 18, 2009 with the investors in the June 2009 bridge
financing. The Security Agreement grants the investors a security
interest in all of our tangible and intangible assets, as further described on
Exhibit A to the Security Agreement. We also entered into a
Subordination Agreement, dated as of June 18, 2009 with the investors in the
June 2009 bridge financing and Mr. Moore. Pursuant to the
Subordination Agreement, Mr. Moore subordinated certain rights to payments under
the Moore Note to the right of payment in full in and in cash of all amounts
owed to the investors pursuant to the June 2009 bridge notes; provided, however,
that principal and interest of the Moore Note may be repaid prior to the full
payment of the investors in certain circumstances.
On
September 22, 2008, we entered into a note purchase agreement with our Chief
Executive Officer, Thomas A. Moore, pursuant to which we agreed to sell to Mr.
Moore, from time to time, Moore Notes. On June 15, 2009, we amended
the terms of the Moore Notes to increase the amounts available from $800,000 to
$950,000 and to change the maturity date of the Moore Notes from June 15, 2009
to the earlier of January 1, 2010 or our next equity financing resulting in
gross proceeds to us of at least $6.0 million.
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 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 the Board based on the terms of the June
2009 bridge financing increasing the number of warrants from one warrant per
dollar invested to two and one half (2 ½) warrants. The final terms are
anticipated to contain the same terms and conditions as warrants issued to
investors in the subsequent financing. As of July 31, 2009, $947,985
in notes were outstanding and payable to Mr. Moore.
On June
15, 2009, the Moore Notes were amended to increase the amounts available
pursuant to the Moore Agreement from $800,000 to $950,000 and change the
maturity date of the Notes from June 15, 2009 to the earlier of January 1, 2010
or our next equity financing resulting in gross proceeds to us of at least $6.0
million. Also the Moore Notes were amended as per the agreement to include the
same warrant provision per dollar invested as the subsequent bridge note
agreement or two and one-half (2½) warrants per one dollar invested instead of
one warrant.
On
October 17, 2007, we issued and sold to institutional and accredited investors
(i) 49,228,334 shares of our common stock and (ii) five-year warrants to
purchase 36,921,250 shares of our common stock exercisable at $0.20 per share,
which we refer to as the “$0.20 warrants”, in a private placement that resulted
in gross proceeds to us of $7,384,235. We refer to this private
placement as the “October 2007 private placement”. Pursuant to the
related placement agency agreement with Carter Securities, LLC, we paid the
placement agent $354,439 in cash commissions and reimbursement of expenses and
issued to it 2,949,333 warrants with an exercise price of $0.20. Our
offering expenses, including legal fees, amounted to $165,250.
Concurrently
with the closing of the October 2007 private placement, we issued and sold to
CAMOFI Master LDC and CAMHZN Master LDC (i) 10,000,000 shares of our common
stock, (ii) $0.20 warrants to purchase 10,000,000 shares of our common stock and
(iii) five-year warrants to purchase 3,333,333 shares of our common stock
exercisable at $0.001 per share, which we refer to as the $0.001 warrants, in a
private placement that resulted in gross proceeds to us of
$1,996,667. Neither the $0.20 warrants nor the $0.001 warrants may be
exercised if, following the exercise, the holder will be deemed to be the
beneficial owner of more than 4.99% of our outstanding shares of our common
stock (unless such holder provides us with 61 days' notice of the holders waiver
of such provisions). In May 2009 all of the 3,333,333 warrants that were
purchased for $0.149 per warrant with an exercise price of $0.001 were exercised
on a cashless basis and 3,299,999 common shares were issued.
Each of
CAMOFI Master LDC and CAMHZN Master LDC are affiliates of our financial advisor,
Centrecourt Asset Management, which we refer to as
Centrecourt. Pursuant to a consulting agreement between us and
Centrecourt dated August 1, 2007, we paid Centrecourt $328,000 in cash and
issued to it 2,483,333 warrants at an exercise price of $0.20, for strategic
advisory services provided to us. Centrecourt transferred the $0.20
warrants to CAMOFI Master LDC and CAMHZN Master LDC.
In
connection with the closing of the October 2007 private placement, we exercised
our right under an agreement dated August 23, 2007 with YA Global Investments,
L.P., which we refer to as Yorkville and f/k/a Cornell Capital Partners, L.P.,
to (i) redeem the outstanding $1.7 million principal amount of our secured
convertible debentures due February 1, 2009 held by Yorkville and (ii)
repurchase from Yorkville warrants to purchase an aggregate of 4,500,000 shares
of our common stock that would have expired on February 1, 2011. The
secured convertible debentures bore interest at 6% per annum and were
convertible into shares of our common stock at a price equal to the lesser of
(i) $0.287 per share or (ii) 95% of the lowest volume weighted average price of
our common stock, or VWAP, during the 30 trading days immediately preceding the
date of conversion. Of the warrants that we repurchased, 4,200,000 were
exercisable at $0.287 per share and 300,000 were exercisable at $0.344 per
share. We paid an aggregate of (i) $2,289,999 to redeem the secured
convertible debentures at the principal amount plus a 20% premium and accrued
and unpaid interest, and (ii) $600,000 to repurchase their
warrants.
On August
24, 2007, we issued and sold an aggregate of $600,000 in principal amount of
promissory notes bearing interest at a rate of 12% per annum and warrants to
purchase an aggregate of 150,000 shares of our common stock to three investors,
including Mr. Moore. Mr. Moore purchased notes in the aggregate
purchase amount of $400,000 and received warrants to purchase 100,000 shares of
our common stock. The promissory notes, and accrued but unpaid
interest thereon, are convertible at the option of the holders into shares of
our common stock upon the closing of a subsequent financing in which we raise
$3.0 million or more in gross proceeds. The conversion rate will be
the greater of the price at which the equity securities issued in the subsequent
financing are sold or the per share price of the last reported trade of our
common stock on the market on which our common stock is then listed, as quoted
by Bloomberg LP. The promissory notes may prepaid at any time prior
to conversion. Mr. Moore converted his $400,000 note into 2,665,667
shares of our common stock and warrants to purchase 2,000,000 shares of our
common stock at $0.20 per share based on the terms of the private placement that
closed on October 17, 2007. Mr. Moore received an interest payment of
$7,101 in cash. The other two note holders also converted the principal amount
of their notes into shares of common stock and received interest in cash. This
note was extinguished in full on October 17, 2007.
In a
letter dated November 13, 2008 from the New Jersey Economic Development
Authority we were notified that our application for the New Jersey Technology
Tax Certificate Transfer Program was approved. Through the State of
New Jersey Program for small businesses, we received a net cash amount of
$922,020 on December 12, 2008 from the sale of our state net operating losses
through December 31, 2007 of $1,084,729. We intend to apply for
additional benefits under the program including the sale of research tax
credits.
Off-Balance
Sheet Arrangements
As of
July 31, 2009, we had no off-balance sheet arrangements, other than our lease
for space. There were no changes in significant contractual obligations during
the nine months ended July 31, 2009.
Critical
Accounting Estimates
The
preparation of financial statements in accordance with GAAP accepted in the U.S.
requires management to make estimates and assumptions that affect the reported
amounts and related disclosures in the financial statements. Management
considers an accounting estimate to be critical if:
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·
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It
requires assumption to be made that were uncertain at the time the
estimate was made, and
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·
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Changes
in the estimate of difference estimates that could have been selected
could have material impact in our results of operations or financial
condition.
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Actual
results could differ from those estimates and the differences could be material.
The most significant estimates impact the following transactions or account
balances: stock compensation, warrant valuation, impairment of intangibles,
dilution caused by ratchets in the warrants and other agreements.
Share-Based
Payment. We record compensation expense associated with stock
options in accordance with SFAS No. 123R, “Share Based Payment,” which
is a revision of SFAS No. 123. We adopted the modified prospective transition
method provided under SFAS No. 123R. Under this transition method, compensation
expense associated with stock options recognized in the first quarter of fiscal
year 2007, and in subsequent quarters, includes expense related to the remaining
unvested portion of all stock option awards granted prior to April 1, 2006, the
estimated fair value of each option award granted was determined on the date of
grant using the Black-Scholes option valuation model, based on the grant date
fair value estimated in accordance with the original provisions of SFAS No.
123.
We
estimate the value of stock options awards on the date of grant using the
Black-Scholes-Merton option-pricing model. The determination of the fair value
of the share-based payment awards on the date of grant is affected by our stock
price as well as assumptions regarding a number of complex and subjective
variables. These variables include our expected stock price volatility over the
term of the awards, expected term, risk-free interest rate, expected dividends
and expected forfeiture rates. The forfeiture rate is estimated using historical
option cancellation information, adjusted for anticipated changes in expected
exercise and employment termination behavior. Our outstanding awards do not
contain market or performance conditions; therefore we have elected to recognize
share based employee compensation expense on a straight-line basis over the
requisite service period.
If
factors change and we employ different assumptions in the application of SFAS
123(R) in future periods, the compensation expense that we record under SFAS
123(R) relative to new grants may differ significantly from what we have
recorded in the current period. There is a high degree of subjectivity involved
when using option-pricing models to estimate share-based compensation under SFAS
123(R). Consequently, there is a risk that our estimates of the fair values of
our share-based compensation awards on the grant dates may bear little
resemblance to the actual values realized upon the exercise, expiration, early
termination or forfeiture of those share-based payments in the future. Employee
stock options may expire worthless or otherwise result in zero intrinsic value
as compared to the fair values originally estimated on the grant date and
reported in our financial statements. Alternatively, value may be realized from
these instruments that are significantly in excess of the fair values originally
estimated on the grant date and reported in our financial
statements.
Warrants
were issued in connection with various financings throughout our history. As of
July 31, 2009, we began estimating the fair value of these instruments using the
Black-Scholes model, which takes into account a variety of factors, including
historical stock price volatility, risk-free interest rates, remaining term and
the closing price of our common stock. Changes in assumptions used to estimate
the fair value of these derivative instruments could result in a material change
in the fair value of the instruments. We believe the assumptions outlined below
used to estimate the fair values of the warrants are reasonable. Accounting for
all outstanding warrants related to our determination that all of the
outstanding warrants were reclassified as liabilities due the fact that the
conversion feature on the June 2009 bridge notes could require us to issue
shares in excess of its authorized amount. All outstanding warrants
have been recorded as a liability effective June 18, 2009, based on their fair
value calculated using the Black-Scholes-Merton valuation model and the
following assumptions: First we estimated the probability of three different
outcomes (i) that we would be able to meet the QEF at the current warrant price
of $0.20 per share, (ii) the QEF price would be $0.15 per share and trigger a
10% discount and (iii) not meet the QEF (“Non-QEF Pricing”) and trigger an
effective per share conversion price equal to 50% of the VWAP per share of the
Common Stock over the five (5) consecutive trading days immediately preceding
the third business day prior to the Maturity Date. We estimated that there was
an equal probability for each scenario. The fair value of the warrant
liability under each outcome was determined and then averaged the outcomes to
estimate the warrant value of $13,036,087 at June 18, 2009.
In
accounting for the June 2009 bridge notes’ embedded conversion feature and
warrants described above we considered the guidance contained in EITF 00-19,
“Accounting for Derivative
Financial Instruments Indexed To, and Potentially Settled In, a Company’s Own
Common Stock,” and SFAS 133 “Accounting for Derivative
Instruments and Hedging Activities.” In accordance with the guidance
provided in EITF 05-2 in order to clarify provisions of EITF 00-19, we
determined that the conversion feature in the June 2009 bridge notes represented
an embedded derivative since the debenture is convertible into a variable number
of shares based upon a conversion formula which could require us to issue shares
in excess of its authorized amount. The convertible debentures are not
considered “conventional” convertible debt under EITF 00-19 and the embedded
conversion feature was bifurcated from the debt host and accounted for as a
derivative liability.
As of
July 31, 2009, we had outstanding warrants to purchase 89,143,801 shares of our
common stock (adjusted for anti-dilution provision to-date) with exercise prices
ranges from $0.187 to $0.287 per share (adjusted for anti-dilution provision
to-date). These warrants include 2,404,125 warrants issued to June
2009 bridge notes at an exercise price of $0.20 per warrant. Most of the
warrants include anti-dilutive provisions that can trigger an adjustment to the
number and price of the warrants outstanding resulting from certain future
equity transactions issued below their exercise price. The Moore Notes also
include warrants not issued but could be issued base on contingent conditions.
See Note 6 Derivative Instruments in the quarterly footnotes for a discussion on
warrants.
New
Accounting Pronouncements
In June
2008, the Financial Accounting Standards Board, or FASB, ratified Emerging
Issues Task Force (EITF) Issue No 07-5, “Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock” (EITF 07-5).
EITF 07-5 mandates a two-step process for evaluating whether an equity-linked
financial instrument or embedded feature indexed to the entities own stock. It
is effective for fiscal years beginning after December 15, 2008, and interim
periods within those fiscal years, which is our first quarter of fiscal 2010.
Many of the warrants issued by us contain a strike price adjustment feature,
which upon adoption of EITF 07-5, may result in the instruments no longer being
considered indexed to our own stock. Accordingly, adoption of EITF 07-5 may
change the current classification (from equity to liability) and the related
accounting for many warrants outstanding at that date, even though we now record
warrants and the embedded derivative as a liability under the guidance contained
in EITF 00-19, “Accounting for Derivative Financial
Instrument Indexed to and Potentially Settled In a Company’s Own Common
Stock,” and SFAS 133 “Accounting for Derivative
Instruments and Hedging Activities”. In accordance with the guidance
provided in EITF 05-2 in order to clarify provisions of EITF 00-19, we
determined that the conversion feature in the June 2009 bridge notes represented
an embedded derivative since the debenture is convertible into a variable number
of shares based upon a conversion formula which could require us to issue shares
in excess of its authorized amount. The convertible debentures are not
considered “conventional” convertible debt under EITF 00-19 and the embedded
conversion feature was bifurcated from the debt host and accounted for as a
derivative liability. We are currently evaluating the impact the adoption of
EITF 07-5 may have on our financial position, results of operation, or cash
flows.
In May
2009, FASB issued Statement of Financial Accounting Standards No. 165,
Subsequent Events (“SFAS 165”), which provides guidance to establish general
standards of accounting for and disclosures of events that occur after the
balance sheet date but before financial statements are issued or are available
to be issued. SFAS 165 also requires entities to disclose the date through which
subsequent events were evaluated as well as the rational as to why the date was
selected. SFAS 165 is effective for interim and annual periods ended after June
15, 2009. We have adopted the provisions of SFAS 165. We have evaluated
subsequent events through the date of issuance of the July 31, 2009 financial
statements, September 23, 2009, and updated their review through November
6, 2009.
In July
2009, FASB issued SFAS No. 168, “FASB Accounting Standards
Codification ™ and the Hierarchy of Generally Accepted Accounting
Principles” — a replacement of FASB Statement No. 162 (“SFAS 168”). With
the issuance of SFAS 168, the FASB Standards Codification, or the Codification,
becomes the single source of authoritative U.S. accounting and reporting
standards applicable for all non-governmental entities, with the exception of
guidance issued by the Securities and Exchange Commission. The Codification does
not change current U.S. GAAP, but changes the referencing of financial standards
and is intended to simplify user access to authoritative U.S. GAAP, by providing
all the authoritative literature related to a particular topic in one place. The
Codification is effective for interim and annual periods ended after September
15, 2009. At that time, all references made to U.S. GAAP will use the new
Codification numbering system prescribed by the FASB. The adoption of SFAS No.
168 will result in the change of disclosures to reflect the new codification
references, but otherwise we do not expect it to have any effect on its
financial statements.
Management
does not believe that any other recently issued, but not yet effective,
accounting standards if currently adopted would have a material effect on the
accompanying financial statements.
DESCRIPTION
OF BUSINESS
General
We are a
development stage biotechnology company with the intent to develop safe and
effective cancer vaccines that utilize multiple mechanisms of immunity. We are
developing a live Listeria vaccine technology
under license from 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, CIN, breast cancer,
prostate cancer, and other cancers. Our lead products in development are as
follows:
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 January 2010.
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Cervical
Cancer
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Phase II Company
sponsored study anticipated to commence in January 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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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, 2008 and
July 31, 2009, we had an accumulated deficit of $17,533,044 and $17,971,843,
respectively, and shareholders’ deficiency of $839,311 and $13,639,132,
respectively.
To date,
we have outsourced many functions of drug development including; manufacturing,
and clinical trials management. Accordingly, the expenses of these
outsourced services account for a significant amount of our accumulated
loss. We cannot predict when, if ever, any of our product candidates
will become commercially viable or approved by the FDA. We expect to
spend substantial additional sums on the continued administration and research
and development of proprietary products and technologies, including conducting
clinical trials for our product candidates, with no certainty that our products
will become commercially viable or profitable as a result of these
expenditures.
Strategy
During
the next 24 months, we intend to strategically focus on developing sufficient
human clinical data on ADXS11-001, our first Listeria construct, to
demonstrate the effectiveness of this technology. This technology is based on
attenuated Listeria
that secrete an antigen LLO fusion protein that can be an effective platform for
multiple therapies against cancer and infectious disease. Overall our clinical
trial plans outlined below are contingent on our ability to raise additional
capital or enter into partnerships. In the U.S., we plan on initiating the
single blind, placebo controlled Phase II clinical trial of ADXS11-001 with
three dosage arms in CIN, a pre cancerous indication. Following the conclusion
of the first arm, we expect to generate an interim assessment of efficacy
approximately 18 months following the start of the single blind, placebo
controlled Phase II Clinical Trial of ADXS11-001
In
parallel with the CIN trial, we also are targeting the development of
ADXS11-001, both in the U.S. and abroad, as a treatment of late stage cervical
cancer in women who have progressed after receiving cytotoxic therapy. We intend
to hold our first Phase II trial in the therapeutic area of cervical cancer in
India. In order to run a second trial in this patient population we are in
advanced discussions with the Gynecologic Oncology Group, which we refer to as
the GOG which receives support from the National Cancer Institute, which we
refer to as the NCI. We anticipate that this trial, with the same patient
population, will be underwritten, in part, by the NCI. Therefore, this Phase II
multi-center study in their network in cervical cancer, is expected to result in
a cost savings to us of approximately $2.5 million to $3.0 million in trial
expenses. Furthermore, once the above trials are underway, we expect to enter
our prostate construct ADXS31-142 (formerly called Lovaxin P) into human
clinical trials as funds or partnerships are secured.
In order
to implement our strategy, we will require substantial additional investment in
the near future. Our failure to raise capital or pursue partnering
opportunities will materially adversely affect both our ability to commence or
continue the clinical trials described above and our business, financial
condition and results of operations, and could force us to significantly curtail
or cease operations. Further, we will not have sufficient resources to develop
fully any new products or technologies unless we are able to raise substantial
additional financing over and above the preferred stock financing on acceptable
terms or secure funds from new partners.
Given our
expertise to genetically modify a host of Listeria vaccines, our longer
term strategy will be to license the commercial development of ADXS11-001 for
the indications of CIN and cervical cancer. On a global basis, these indications
are extremely large and will require one or more significant partners. We do not
intend to engage in commercial development beyond Phase II without entering into
one or more partnerships or a license agreement.
We intend
to continue to devote a substantial portion of our resources to 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. These
activities may require significant financial resources, as well as areas of
expertise beyond those readily available. In order to provide additional
resources and capital, we may enter into research, collaborative or commercial
partnerships, joint ventures, or other arrangements with competitive or
complementary companies, including major international pharmaceutical companies
or universities.
Background
Cancer
Cancer is
the second largest cause of death in the U.S., exceeded only by heart
disease. The cost of treating cancer patients in 2007 was estimated
to be $219.2 billion in healthcare costs and another $18.2 billion in indirect
costs resulting from morbidity and lost productivity (source: Facts &
Figures 2008, American Cancer Society). The American Cancer Society’s
most recent estimates for newly diagnosed cervical cancer in the U.S. in 2009
was 11,270 and numbers for newly diagnosed CIN are approximately about 250,000
patients per year based on 3.5 million abnormal Pap smears
(source: Jones HW, Cancer 1995:76:1914-18; Jones BA and Davey, Arch
Pathol Lab Med 2000; 124:672-81). Overall predicted incidence and
mortality rates for 2009 are set forth below:
Immune
System and Normal Antigen Processing
Living
creatures, including humans, are continually confronted with potentially
infectious agents. The immune system has evolved multiple mechanisms
that allow the body to recognize these agents as foreign, and to target a
variety of immunological responses, including innate, antibody, and cellular
immunity that mobilize the body’s natural defenses against these foreign agents
and will eliminate them.
Innate
Immunity:
Innate
immunity is the first step in the recognition of a foreign antigen, and
underlies an adaptive (antigen specific) response by
lymphocytes. This non-specific response by the immune system results
in the release of various soluble mediators of immune response such as
cytokines, chemokines and other molecules.
Exogenous
pathway of Adaptive Immunity (Class II pathway):
Proteins
and foreign molecules ingested by Antigen Processing Cells, or APCs, are broken
down inside digestive vacuoles into small pieces, called peptides, and the
pieces are combined with proteins called Class 2 MHC (for Major
Histocompatibility Complex) in a part of the cell called the endoplasmic
reticulum. The MHC-peptide, termed and MHC-2 complex from the Class 2
(or exogenous) pathway, is then pushed out to the cell surface where it
interacts with certain classes of lymphocytes (CD4+) called helper T-cells that
produce induce a proliferation of helper T cells that assist in the maturation
of cytotoxic T-lymphocytes. This system is called the exogenous
pathway, since it is the prototypical response to an exogenous antigen like
bacteria. (Listeria generated MHC-2
responses are directed at the activation of helper T cell activation, as Listeria tends not to
stimulate antibody formation.)
Endogenous
pathway of Adaptive Immunity (Class I pathway):
There
exists another adaptive immune pathway, called the endogenous
pathway. In this system, unusual proteins created within the
cytoplasm of the APC (as opposed to within he digestive phagosome), are broken
up into peptides in the cytoplasm and directed into the endoplasmic reticulum,
where it is incorporated into an MHC-1 protein and trafficked to the cell
surface. This signal then calls effector cells of the cellular immune
system, especially CD8+ cytotoxic T-lymphocytes, to come and kill the
cell. The endogenous pathway is needed for elimination of
virus-infected or cancerous cells.
Listeria based vaccines are
unique for many reasons, one of which is that unlike viral vectors, DNA or
peptide antigens or other vaccines, Listeria stimulates all of
the above mechanisms of immune action. We use a bioengineered form of
Listeria to activate
the immune system to treat cancer, infectious diseases, or allergic
syndromes. Our technology allows the body to recognize
tumor-associated or tumor-specific antigens as foreign, thus creating the immune
response needed to attack the cancer. It does this by utilizing a
number of biologic characteristics of the Listeria bacteria and Advaxis
proprietary antigen-fusion protein technology to stimulate multiple therapeutic
immune mechanisms simultaneously in an integrated and coordinated
manner.
Mechanism
of Action
Listeria monocytogenes (Lm) is a bacterium well
known to medical science because it can cause an infection in
humans. Listeria is a pathogen that
causes food poisoning, typically in the very old, the very young, people who are
either immunocompromised or who eat a large quantity of the microbe as can occur
in spoiled dairy products. It is not laterally transmitted from
person to person. As Lm is in the soil and thus found on leafy
vegetables, in meat and dairy products, and is a common microbe in our
environment we are exposed to it constantly. Most people ingest Listeria without being aware
of it, but in high quantities or in immune suppressed people Listeria can cause various
clinical conditions, including sepsis, meningitis and placental infections in
pregnant women. This is rare, and fortunately, many common
antibiotics can kill and sterilize Listeria.
Because
Listeria is a live
bacterium it stimulates the innate immune system, thereby priming the adaptive
immune system to better respond to the specific antigens that the Listeria carries, which
viruses and other vectors do not do. This is a non-specific
stimulation of the overall immune system that results when certain classes of
pathogens such as bacteria (but not viruses) are detected. It
provides some level of immune protection and also serves to prime the elements
of adaptive immunity to respond in a stronger way to the specific antigenic
stimulus. Listeria stimulates a strong
innate response which engenders a strong adaptive response.
APCs are
the scavengers in the body that circulate looking for foreign
invaders. When they find one they ingest it, break it down, and
provide the fragments as molecular targets for the immune system to
attack. In this way they are the cells that direct a specific immune
response, and Listeria
has the ability to infect them.
When
Listeria enters the
body, it is seen as foreign by the antigen processing cells and ingested into
cellular compartments called phagolysosomes, whose destructive enzymes kill most
of the bacteria. A certain percentage of these bacteria, however, are able to
break out of the phagolysosomes and enter into the cytoplasm of the cell, where
they are relatively safe from the immune system. The bacteria
multiply in the cell, and the Listeria is able to move to
its cell surface so it can push into neighboring cells and
spread.
Figs
1-7. When Listeria enters the body, it
is seen as foreign by the antigen processing cells and ingested into cellular
compartments called phagolysosomes, whose destructive enzymes kill most of the
bacteria, fragments of which are then presented to the immune system via the
exogenous pathway.
Figs
8-10. A certain percentage of bacteria are able to break out of the
lysosomes and enter into the cytoplasm of the cell, where they are safe from
lysosomal destruction. The bacteria multiply in the cell, and the
Listeria is able to
migrate into neighboring cells and spread without entering the extracellular
space. Antigen produced by these bacteria enter the Class I pathway
and directly stimulate a cytotoxic T cell response.
It is the
details of Listeria
intracellular activity that are important for understanding the Advaxis
technology. Inside the lysosome, Listeria produces
listeriolysin-O, or LLO, a protein that digests a hole in the membrane of the
lysosome that allows the bacteria to escape into the cytoplasm. Once
in the cytoplasm, however, LLO is also capable of digesting a hole in the outer
cell membrane. This would destroy the host cell, and spill the
bacteria back out into the intercellular space where it would be exposed to more
immune cell attacks and destruction. To prevent this, the body has
evolved a mechanism for recognizing enzymes with this capability based upon
their amino acid sequence. The sequence of approximately 30 amino
acids in LLO and similar molecules is called the PEST sequence (for the
predominant amino acids it contains) and it is used by normal cells to force the
termination of proteins that need only have a short life in the
cytoplasm. This PEST sequence serves as a routing tag that tells the
cells to route the LLO in the cytoplasm to the proteosome for digestion, which
terminates its action and provides fragments that then go to the endoplasmic
reticulum, where it is processed just like a protein antigen in the endogenous
pathway to generate MHC-1 complexes.
This
mechanism is used by Listeria to its benefit
because the actions of LLO enable the bacteria to avoid digestion in the
lysosome and escape to the cytosol where they can multiply and spread and then
be neutralized so that it does not kill the host cell. Advaxis is
using a technology that co-opts this mechanism by creating a protein that is
comprised of the cancer antigen fused to a non-hemolytic portion of the LLO
molecule that contains the PEST sequence. This serves to route the
molecule for accelerated proteolytic degradation which accelerates both the rate
of antigen breakdown and the amount of antigen fragments available for
incorporation in to MHC-1 complexes, thus increasing the stimulus to activate
cytotoxic T cells against a tumor specific antigen. Further, because LLO is a
primary virulence factor for Lm and thus is a molecule to
which humans have evolved a strong immune response, using a non-hemolytic
fragment of LLO (which is thus safe) fused to an antigen, Advaxis vaccines
secrete an antigen and an adjuvant in a single molecule.
Other
mechanisms that Advaxis vaccines employ include Listeria’s ability to increase the
synthesis of myeloid cells such as APCs and T cells, and to stimulate the
maturation of immature myeloid cells to increase the number of available
activated immune cells that underlie a cancer killing
response. Immature myeloid cells actually inhibit the immune system
and Listeria removes
this inhibition within the actual tumor. Also, Listeria and LLO both
stimulate the synthesis, release, and expression of various chemicals which
stimulate a therapeutic immune response. These chemicals are called
cytokines, chemokines and co-stimulatory molecules. By doing this,
not only are immune cells activated to kill cancers and clear them from the
body, but local environments within tumors are created that support and
facilitate a therapeutic response. In a manner that we believe to be
unique to Advaxis vaccines, our proprietary antigen-LLO fusion proteins, when
delivered by Listeria
reduce the number of cells within tumors called regulatory T cells, or Tregs,
which are known to inhibit a therapeutic anticancer response. This
does not occur when Listeria is engineered to
deliver only a tumor specific antigen. The ability to reduce the
effect of Tregs is currently under clinical investigation by other companies and
is believed to be a significant mechanism of achieving a therapeutic response.
Listeria has other
effects as well, such as facilitating the transit of activated immune cells from
the blood and into tumors.
The
ability to reduce the number of Tregs within tumors appears to be as important
as activating the immune system against an antigen. Advaxis live Listeria vaccines have many
diverse salutary effects, not the least of which is the ability to reduce
regulatory Tregs within tumors. Over the past few years it has become
known that the reason many previous immunologic cancer treatments have failed is
that although they were able to strongly activate the immune system, they were
rendered ineffective by endogenous sources of immune inhibition within the
tumors themselves. Tregs have the ability to turn off activated
immune cells so that they no longer function within the tumor. We
have published on 2 occasions that our live Listeria vaccines that
secrete a proprietary fusion protein comprised of a non-hemolytic fragment of
the Listeria virulence
factor LLO fused to a tumor specific antigen will reduce these inhibitory cells
within tumors. In this way, our vaccines not only strongly stimulate
the immune system, but also modify the tumor micro-environment in a manner that
allows the immune system to kill and clear tumor cells.
Advaxis
live Listeria vaccines
also have the ability to modify the function of vascular endothelial cells in a
way that facilitates the trafficking of activated immune cells out of the blood
and into the tumor, where they are therapeutically effective. One
property of cancer is the modification of vascular cells to prevent activated
immune cells from transiting into the tumor. Our vaccines appear to
overcome this source of anti-tumor inhibition.
Many of
the immune effector cells, such as dendritic cells, macrophages, mast cells,
Langerhans cells and others are myeloid cells. Our vaccines have the
ability to accelerate the synthesis and maturation of these cells, as well as
their antigen specific activation, to increase the power and efficiency of the
immune response.
It should
also be noted that the live Listeria vaccines Advaxis
creates are attenuated from 10,000 to 100,000 times in order that they will not
cause disease themselves.
Thus,
Listeria vaccines
stimulate every immune pathway simultaneously, and in an integrated
manner. It has long been recognized that cytotoxic T lymphocytes, or
CTL, are the elements of the immune system that kill and clear cancer
cells. The amplified CTL response to Listeria vaccines are
arguably the strongest stimulator of CTL yet developed, but just as important is
the ability Advaxis vaccines have to create a local tumor environment in which
these cells can be effective. This efficacy likely results in part
from the fusion of LLO to the secreted tumor antigen since many investigators
have shown that LLO is a very strong source of immune stimulation independent of
Listeria. By
fusing a molecule with strong adjuvant properties to a tumor antigen, and then
having it synthesized and secreted by live bacteria directly into the cytoplasm
of Antigen Presenting Cells, vascular endothelium and other relevant tissues an
unusually powerful and complete immune response is generated.
Recently
it has been shown that Lm-LLO vaccines can cause
epitope spreading. This means that these vaccines can stimulate the
immune system to respond to more antigens than the one they are designed to
attack. This happens when tumor cells are killed by the immune system
in response to the administered vaccine and portions of those killed cells are
then recognized by the immune system and they too become targets of an immune
attack. This broadens the immune attack and results in a more
therapeutic response.
Thus,
what makes Advaxis live Listeria vaccines so
effective are a combination of effects that stimulate multiple arms of the
immune system simultaneously in a manner that generates an integrated
physiologic response conducive to the killing and clearing of tumor
cells. These mechanisms include:
|
1.
|
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.
|
Research
and Development Program
Overview
We use
genetically engineered and highly attenuated Listeria monocytogenes as a
therapeutic agent. We start with an attenuated strain of Listeria , and then add to
this bacterium multiple copies of a plasmid that encodes a fusion protein
sequence that includes a fragment of the LLO molecule joined to the tumor
antigen of interest. This protein is secreted by the Listeria inside the antigen
processing cells, and other cells that Listeria infects which then
results in the immune response as discussed above.
We can
use different tumor, infectious disease, or other antigens in this
system. By varying the antigen, we create different therapeutic
agents. Our lead agent, ADXS11-001, uses a HPV derived antigen that
is present in cervical cancers. Lovaxin B uses Her2/neu, an antigen
found in many breast cancer and melanoma cells, to induce an immune response
that should be useful in treating these conditions.
Partnerships
and Agreements
University
of Pennsylvania
On July
1, 2002 we entered into a 20-year exclusive worldwide license, with Penn with
respect to the innovative work of Yvonne Paterson, Ph.D., Professor of
Microbiology in the area of innate immunity, or the immune response attributable
to immune cells, including dendritic cells, macrophages and natural killer
cells, that respond to pathogens non-specifically. This agreement has
been amended from time to time and has been amended and restated as of
February 13, 2007.
This
license, unless sooner terminated in accordance with its terms, terminates upon
the later (a) expiration of the last to expire Penn patent rights; or (b) twenty
years after the effective date of the license. The license provides
us with the exclusive commercial rights to the patent portfolio developed at
Penn as of the effective date of the license, in connection with Dr. Paterson
and requires us to raise capital, pay various milestone, legal, filing and
licensing payments to commercialize the technology. In exchange for
the license, Penn received shares of our common stock which currently represents
approximately 4.7% of our common stock outstanding on a fully-diluted
basis. In addition, Penn is entitled to receive a non-refundable
initial license fee, license fees, royalty payments and milestone payments based
on net sales and percentages of sublicense fees and certain commercial
milestones. Under the licensing agreement, Penn is entitled to
receive 1.5% royalties on net sales in all countries. Notwithstanding
these royalty rates, we have agreed to pay Penn a total of $525,000 over a
three-year period as an advance minimum royalty after the first commercial sale
of a product under each license (which we are not expecting to begin paying
within the next five years). In addition, under the license, we
are obligated to pay an annual maintenance fee on December 31, in 2008, 2009,
2010, 2011 and 2012 and each December 31st thereafter for the remainder of the
term of the agreement of $50,000, $70,000, $100,000, $100,000 and $100,000,
respectively until the first commercial sale of a Penn licensed
product. Overall the amended and restated agreement payment terms
reflect lower near term requirements but the savings are offset by higher long
term milestone payments for the initiation of a Phase III clinical trial and the
regulatory approval for the first Penn Licensed Product. We are
responsible for filing new patents and maintaining and defending the existing
patents licensed to use and we are obligated to reimburse Penn for all
attorneys fees, expenses, official fees and other charges incurred in the
preparation, prosecution and maintenance of the patents licensed from
Penn.
Furthermore,
upon the achievement of the first sale of a product in certain fields, Penn will
be entitled to certain milestone payments, as follows: $2.5 million will be due
for first commercial sale of the first product in the cancer
field. In addition, $1.0 million will be due upon the date of first
commercial sale of a product in each of the secondary strategic fields
sold.
As a
result of our payment obligations under the license assuming we have net sales
in the aggregate amount of $100.0 million from our cancer products, our total
payments to Penn over the next ten years could reach an aggregate of $5.4
million. If over the next 10 years our net sales total an aggregate
amount of only $10.0 million from our cancer products, total payments to Penn
could be $4.4 million.
Pursuant
to an option contained in our existing license agreement with Penn, as amended,
we have been in negotiations with Penn since March 2007 to further amend and
restate the terms of the license agreement to acquire the rights to use an
additional 12 dockets (patentable research agents) under Penn’s ownership which,
as of July 31, 2009, have generated approximately 22 additional patent
applications for Listeria
and LLO-based vaccine dockets. “Docket number” or “case
number” refers to a subject on which a patent application or applications are
filed. A docket number or case number can contain several applications, which
are usually related applications. Related applications are sometimes assigned to
more than one docket number, for example if the inventor list is not identical.
As a
condition to our exercising this option and entering into an amendment, we must,
among other things, pay Penn a mutually agreeable option exercise fee and
reimburse Penn for all of its historically accrued patent and licensing expenses
relating to these patents (dockets), including their legal and filing
fees. As of July 31, 2009, such expenses totaled approximately
$447,000. Although the option exercise period formally expired in
June 2009, we remain in negotiations with Penn over the form of payment and
expect to reach a conclusion at the close of our next financial
raise. If we fail to acquire a license to use the additional dockets
and patent applications, our patent position may be materially and adversely
affected. In addition, as of July 31, 2009, approximately $315,000 in
fees and expense are due and owing to Penn by us under our existing license
agreement and other related agreements. While we consider our relationship with
Penn to be good, we are in frequent communications over payment of past due
invoices and other payables due to our lack of cash. If we fail to
reach a mutual agreement, Penn may issue a default notice and we will have 60
days to cure the breach or be subject to the termination of the
agreement.
Strategically
we continue to enter into sponsored research agreements with Dr. Paterson and
Penn to generate new intellectual property and to exploit all existing
intellectual property covered by the license.
Penn is
not involved in the management of our company or in our decisions with respect
to exploitation of the patent portfolio, except that Dr. Paterson is the
Chairperson of our Scientific Advisory Board.
Dr.
Yvonne Paterson
Dr.
Paterson is a Professor in the Department of Microbiology at Penn and the
inventor of our licensed technology. She has been an invited speaker
at national and international health field conferences and leading academic
institutions. She has served on many federal advisory boards, such as
the NIH expert panel to review primate centers, the Office of AIDS Research
Planning Fiscal Workshop, and the Allergy and Immunology NIH Study
Section. She has written over one hundred and forth publications in
immunology (including a recently published book) with emphasis during the last
several years on the areas of HIV, AIDS and cancer research. Her
instruction and mentorship has trained over forty post-doctoral and doctoral
students in the fields of Biochemistry and Immunology. She was
recently elected a fellow of the American Association for the Advancement of
Science.
Dr.
Paterson is currently the principal investigator on several grants from the
federal government and charitable trusts and the program director of training
grants. Her research interests are broad, but her laboratory has been
focused for the past ten years on developing novel approaches for prophylactic
vaccines against infectious disease and immunotherapeutic approaches to
cancer. The approach of the laboratory is based on a long-standing
interest in the properties of proteins that render them immunogenic and how such
immunogenicity may be modulated within the body.
Consulting
Agreement. On January 28, 2005 we entered into a consulting
agreement with Dr. Paterson, which expired on January 31, 2009. We
are currently in the process of establishing a revised agreement to continue to
have access to Dr. Paterson’s consulting services for one full day per
week. There can be no assurance that we will be able to enter into a
new agreement with Dr. Paterson. Dr. Paterson has advised us on an
exclusive basis on various issues related to our technology, manufacturing
issues, establishing our lab, knowledge transfer, and our long-term research and
development program. Pursuant to the expired agreement, Dr. Paterson
received $7,000 per month. Upon the closing of an additional $9.0
million in equity capital, Dr. Paterson’s rates would have increased to $9,000
per month. Also, under the prior Agreement, on February 1, 2005, she
received options to purchase 400,000 shares of our common stock at an exercise
price of $0.287 per share which are now fully vested. In total she
holds 704,365 shares of our common stock and 569,048 fully vested options to
purchase shares of our common stock.
We intend
to enter into additional sponsored research agreements with Penn in the future
with respect to research and development on our product candidates.
We
believe that Dr. Paterson’s continuing research will serve as a source of
ongoing findings and data that both supports and strengthen the existing
patents. Her work will expand the claims of the patent portfolio
(potentially including adding claims for new tumor specific antigens, the
utilization of new vectors to deliver antigens, and applying the technology to
new disease conditions) and create the infrastructure for the future filing of
new patents.
Dr.
Paterson is also the Chairman of our Scientific Advisory Board.
The
Sage Group
On
January 7, 2009 we signed an Agreement with The Sage Group, which we refer to as
Sage, in a program to commercialize our vaccines. They are
health-care strategy consultants and are based in New Jersey. Their
Agreement is for $5,000 per month starting in January through April 2009 and
$10,000 per month from May 1 through February 2010 plus 5% of the deal, if
completed in the first 24 months, 2 1/2% in the twelve months
thereafter.
Dr.
David Filer
On
January 7, 2005 we entered into a consulting agreement with Dr. David Filer, a
biotech consultant. The Agreement provides that Dr. Filer spends
three days per month assisting us with our development efforts, reviewing our
scientific, technical and business data and materials and introducing us to
industry analysts, institutional investor collaborators and strategic
partners. In consideration for the consulting services we pay Dr.
Filer $2,000 per month. In addition, Dr. Filer received options to
purchase 40,000 shares of common stock which are currently
vested. As of October 1, 2007 we entered into a new two year
agreement at a monthly fee of $5,000 including 1,500,000 $0.20 warrants
exercisable at $0.20 per warrant as consideration for his assistance in the
raise on October 17, 2007 as well a his advisory services and
assistance. This agreement is cancelable with 90 days advance
notice.
Freemind
Group LLC
We have
entered into an agreement with Freemind Group LLC, which we refer to as
Freemind, to develop and manage our grant writing strategy and application
program with Advaxis to pay Freemind according to a fee structure based on
achievement of grants awarded to us at the rate of 6-7% of the grant
amount. Advaxis will also pay Freemind fixed consulting fees ranging
from $5,000-7,000 depending on the type of grant application
submitted. Freemind has extensive experience in accessing public
financing opportunities and the resources of the national SBIR and related
NIH/NCI programs. Freemind has assisted us in the past to file grant
applications with NIH covering the use of ADXS11-001 for cervical dysplasia. We
have paid Freemind as of October 31, 2008, fees aggregating
$29,500. We currently have no future plans to use Freemind and have
been successfully writing our own grants.
University
of California
On March
14, 2004 we entered into a nonexclusive license and bailment agreement with the
Regents of the UCLA to commercially develop products using the XFL7 strain of
Listeria monoctyogenes
in humans and animals. The agreement is effective for a period
of 15 years and is renewable by mutual consent of the
parties. Advaxis paid UCLA an initial licensee fee and continues to
pay annual maintenance fees for the use of the Listeria. We may
not sell products using the XFL7 strain Listeria other than agreed
upon products or sublicense the rights granted under the license agreement
without the prior written consent of UCLA.
Cobra
Biomanufacturing PLC
In July
2003, we entered into an agreement with Cobra Biomanufacturing PLC, which we
refer to as Cobra, for the purpose of manufacturing our cervical cancer vaccine
ADXS11-001. Cobra has extensive experience in manufacturing gene
therapy products for investigational studies. Cobra is a full service
manufacturing organization that manufactures and supplies DNA-based therapeutics
for the pharmaceutical and biotech industry. These services include
the Good Manufacturing Practices, or GMP, manufacturing of DNA, recombinant
protein, viruses, mammalian cell products and cell banking. Cobra’s
manufacturing plan for us involves several manufacturing stages, including
process development, manufacturing of non-GMP material for toxicology studies
and manufacturing of GMP material for the Phase I trial. The
agreement to manufacture expired in December 2005 upon the delivery and
completion of stability testing of the GMP material for the Phase I
trial. Cobra has agreed to surrender the right to $300,000 of its
outstanding fees for manufacturing in exchange for future royalties from the
sales of ADXS11-001 at the rate of 1.5% of net sales, with royalty payments not
to exceed $2.0 million.
In
November 2005, in order to secure production of ADXS11-001 on a
long-term basis as well as other drug candidates which we are developing, we
entered into a Strategic Collaboration and Long-Term Vaccine Supply Agreement
for Listeria Cancer
Vaccines, under which Cobra will manufacture experimental and commercial
supplies of our Listeria cancer vaccines,
beginning with ADXS11-001. This agreement leaves the existing
agreement in place with respect to the studies contemplated therein, and
supersedes a prior agreement and provides for mutual exclusivity, priority of
supply, collaboration on regulatory issues, research and development of
manufacturing processes that have already resulted in new intellectual property
owned by Advaxis, and the long-term supply of live Listeria based vaccines on a
discounted basis.
In
October 20, 2007 we entered into a production agreement with Cobra to
manufacture our Phase II clinical materials using a new methodology now required
by the United Kingdom, and likely to be required by other regulatory bodies in
the future. The contract is for £274,500 plus consumables and as of
October 31, 2008 we have we have recorded $543,620 in full excluding
consumables. In addition, we entered into a contract for £47,250 to
fill the Listeria in
vials and as of October 31, 2008, we have recorded $107,793 in full
payment. We also have several other small contracts to cover,
testing, stability and storage of our clinical supplies.
LVEP
Management, LLC
We
entered into a consulting agreement with LVEP Management, LLC, which we refer to
as LVEP, dated as of January 19, 2005, and amended on April 15, 2005, and
October 31, 2005, pursuant to which Mr. Appel served as our Chief Executive
Officer, Chief Financial Officer and Secretary and was compensated by consulting
fees paid to LVEP. LVEP is owned by the estate of Scott Flamm
(deceased January 2006) previously, one of our directors and a principal
stockholder. Pursuant to an amendment dated December 15,
2006. Mr. Appel resigned as our President and Chief Executive Officer
and Secretary as of December 15, 2006, but remains as a member of our board of
directors and remained as a consultant to us until December 15,
2007. The consulting agreement terminated on December 15,
2008. Mr. Appel devoted 50% of his time over the first twelve months
of the consulting period to support us. Also as a consultant, he was
paid at a rate of $22,500 per month in addition to benefits as provided to other
company officers. He received severance payments over an additional
twelve months at a rate of $10,416.67 per month and was reimbursed for family
health care. All his stock options became fully vested on December
15, 2006. Also, Mr. Appel was issued 1,000,000 shares of our common
stock on January 2, 2007. He received a $250,000 bonus with $100,000
paid on January 3, 2007 and the remainder was paid in October
2007.
On
February 11, 2008 we and LVEP agreed to satisfy the balances of the LVEP
Agreement with cash payments of $130,000 and $20,000 in our common stock
(153,846 shares). The cash payment was made on February 12, 2008 and
the shares were issued on April 4, 2008 and recorded at the market value of
$14,615.
Pharm-Olam
International Ltd.
In April
2005, we entered into a consulting agreement with Pharm-Olam International Ltd.,
which we refer to as POI, whereby POI is to execute and manage our Phase I
clinical trial in ADXS11-001 for a fee of $430,000 plus reimbursement of certain
expenses of $181,060. On December 13, 2006 we approved a change order
reflecting the changes to the protocol the cost of which is estimated at
$92,000 for a total contractual obligation of $522,000 excluding certain
pass through expenses. On February 20, 2008, we approved change order
2 reflecting changes in the study for $175,000 in additional service fees for a
total contractual service fee of $697,000. As of October 31, 2008 we
have paid $440,650 toward the $697,000 portion of the agreement. In
total the pass-through expenses ($119,346), patient cost ($135,272) and service
fees totaled $951,618.
The
Investor Relations Group, Inc.
We
entered into an agreement with The Investor Relations Group, Inc., which we
refer to as IRG, whereby IRG was retained to serve as an investor relations and
public relations consultant. In consideration for performing its
services, IRG was paid $10,000 per month plus out of pocket expenses, and
200,000 shares of our common stock. On December 1, 2008, we
terminated this agreement.
Biologics
Consulting Group, Inc.
On June
1, 2006 we entered into an agreement with Biologics Consulting Group, Inc.,
which we refer to as BCG, and on June 11, 2007, we entered into an amendment No.
1 to provide biologics regulatory consulting services to us, on an as needed
basis, in support of the IND submission to the FDA. The tasks to be performed
under this Agreement will be agreed to in advance by us and BCG. The
term of the amendment No. 1 was from June 1, 2007 to June 1, 2008. In
April 2009 we entered into Amendment No. 2 which set June 1, 2008 as the
effective date and amended the term from June 1, 2006 through June 1,
2010.
Numoda
Corporation
On June
19, 2009 we entered into a Master Agreement and on July 8, 2009 we entered into
a Project Agreement with Numoda, a leading clinical trial and logistics
management company, to oversee Phase II clinical activity with ADXS11-001 for
the treatment of invasive cervical cancer and CIN. Numoda will be
responsible for integrating oversight and logistical functions with the clinical
research organizations, contract laboratories, academic laboratories and
statistical groups involved. The scope of this agreement covers over
three years and is estimated to cost $8.0 million for both trials.
MediVector,
Inc.
In May
2007, we entered into a Master Service Agreement with MediVector, Inc., which we
refer to as MI, covering three projects to serve in clinical study planning,
management and execution for our upcoming Phase II clinical study. We
paid MI $71,000 for its services. In early 2008 we terminated all
agreements.
Patents
and Licenses
Dr.
Paterson and Penn have invested significant resources and time in developing a
broad base of intellectual property around the cancer vaccine platform
technology to which on July 1, 2002 we entered into a 20-year exclusive
worldwide license and a right to grant sublicenses pursuant to our license
agreement with Penn. As of July 31, 2009 Penn has 17 issued and
18 pending patents in the U.S. and other large countries including Japan, and
the European Union, through the Patent Cooperation Treaty system pursuant to
which we have an exclusive license to exploit the patents. While Penn
holds 10 additional patents and patent applications in smaller countries, we
have decided not to continue them for economic reasons. We believe
that these patents will allow us to take a lead in the U.S. in the field of
Listeria-based
therapy.
United
States
In 2001,
an issue arose regarding the inventorship of U.S. Patent 6,565,852 and U.S.
Patent Application No. 09/537,642. These patent rights are included
in the patent rights licensed by Advaxis from Penn. It is
contemplated by GlaxoSmithKline plc, which we refer to as GSK, Penn and us that
the issue will be resolved through: (1) a correction of inventorship to
add certain GSK inventors, (2) where necessary and appropriate, an assignment of
GSK’s possible rights under these patent rights to Penn, and (3) a sublicense
from us to GSK of certain subject matter, which is not central to our business
plan. To date, this arrangement has not been finalized and we cannot
assure that this issue will ultimately be resolved in the manner described
above.
Pursuant
to our existing license with Penn, we had an option to license from Penn
any new future invention conceived by either Dr. Yvonne Paterson or by Dr. Fred
Frankel in the vaccine area that expired on June 17, 2009. Under our
license agreement with Penn, we expanded our intellectual property base and
gained access to inventions. Although the option exercise period
formally expired in June 2009, we remain in negotiations with Penn to obtain
additional patent licenses. Further, our previous consulting agreement
with Dr. Paterson provided, among other things, that, to the extent that Dr.
Paterson’s consulting work resulted in new inventions, such inventions were
assigned to Penn, and we have access to those inventions under license
agreements to be negotiated. This agreement is currently being
revised as of October 1, 2009.
Our
approach to the intellectual property portfolio is to create significant
offensive and defensive patent protection for every product and technology
platform that we develop. We work closely with our patent counsel to
maintain a coherent and aggressive strategic approach to building our patent
portfolio with an emphasis in the field of cancer vaccines.
We are
aware of a private company, Anza Therapeutics, Inc (formerly Cerus Corporation),
which, is no longer in existence, but had been developing Listeria
vaccines. We believe that through our exclusive license with Penn we
have earliest known and dominant patent position in the U.S. for the use of
recombinant Listeria
monocytogenes expressing proteins or tumor antigens as a vaccine for the
treatment of infectious diseases and tumors. We successfully defended
our intellectual property by contesting a challenge made by Anza to our patent
position in Europe on a claim not available in the U.S. The EPO Board
of Appeals in Munich, Germany has ruled in favor of The Trustees of Penn and its
exclusive licensee Advaxis and reversed a patent ruling that revoked a
technology patent that had resulted from an opposition filed by
Anza. The ruling of the EPO Board of Appeals is final and can not be
appealed. The granted claims, the subject matter of which was
discovered by Dr. Yvonne Paterson, scientific founder of Advaxis, are directed
to the method of preparation and composition of matter of recombinant bacteria
expressing tumor antigens for treatment of patients with cancer.
Based on
searches of publicly available databases, we do not believe that Anza or any
other third party owns any published Listeria patents or has any
issued patent claims that might materially and adversely affect our ability
to operate our business as currently contemplated in the field of recombinant
Listeria monocytogenes.
Additionally, our proprietary position that is the issued patents and licenses
for pending applications restricts anyone from using plasmid based Listeria constructs, or those
that are bioengineered to deliver antigens fused to LLO, ActA, or fragments of
LLO or ActA.
On
January 7, 2009 we made the decision to discontinue our use of the Trademark
Lovaxin and write-off of our intangible assets for trademarks resulting in an
asset impairment of $91,453 as of October 31, 2008. We developed a
classic coding system for our constructs. The rationale for this
decision stemmed from several legal challenges to the Lovaxin name over the last
two years and certain rules in Title 21 of the Code of Federal Regulations which
do not allow companies to use names that are assigned to drugs in development
after marketing approval. We will therefore focus company resources
on product development and not the defense the Lovaxin name.
On May
26, 2009, the PTO approved our patent application “Compositions and Methods for
Enhancing the Immunogenicity of Antigencs”. This patent application
covers the use of Listeria monocytogenes (Lm)
protein ActA and fragments of this protein for use in the creation of antigen
fusion proteins. This intellectual property protects a unique strain
of Listeria monocytogenes for use as a
vaccine vector.
On
February 10, 2009 the U.S. PTO issued patent 7,488,487 “Methods of Inducing Immune response
Through the Administration of Auxotrophic Attenuated DAT/DAL Double Mutant
Listeria Strains”, assigned to Penn and licensed to us. This
intellectual property protects a unique strain of Listeria monocytogenes for use as a
vaccine vector. This new strain of Listeria is an improvement
over the strain currently in clinical testing as it is more attenuated, more
immunogenic, and does not have an antibiotic resistance gene
inserted. We believe that this technology will make our product more
effective and easier to obtain FDA regulatory approval.
Governmental
Regulation
The
Drug Development Process
The FDA
requires that pharmaceutical and certain other therapeutic products undergo
significant clinical experimentation and clinical testing prior to their
marketing or introduction to the general public. Clinical testing,
known as clinical trials or clinical studies, is either conducted internally by
pharmaceutical or biotechnology companies or is conducted on behalf of these
companies by contract research organizations.
The
process of conducting clinical studies is highly regulated by the FDA, as well
as by other governmental and professional bodies. Below, we describe
the principal framework in which clinical studies are conducted, as well as
describe a number of the parties involved in these studies.
Protocols. Before
commencing human clinical studies, the sponsor of a new drug must typically
receive governmental and institutional approval. In the U.S., Federal
approval is obtained by submitting an IND to the FDA and amending it for each
new proposed study. The clinical research plan is known in the industry as a
protocol. A
protocol is the blueprint for each drug study. The protocol sets
forth, among other things, the following:
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Who
must be recruited as qualified participants and who is to be
excluded;
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how
often, and how to administer the drug and at what
dose(s);
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what
tests to perform on the participants;
and
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what
evaluations are to be made and how the data will be
assessed.
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Institutional Review Board (Ethics
Committee). An institutional review board is an independent
committee of professionals and lay persons which reviews clinical research
studies involving human beings and is required to adhere to guidelines issued by
the FDA. The institutional review board does not report to the FDA and its
members are not appointed by the FDA, but its records are audited by the
FDA. All clinical studies must be approved by an institutional review
board. The institutional review board is convened by the institution
where the protocol will be conducted and its role is to protect the rights of
the participants in the clinical studies. It must approve the
protocols to be used, and then oversees the conduct of the study, including: the
communications which we or the contract research organization conducting the
study at that specific site proposes to use to recruit participants, and
the form of consent which the participants will be required to sign prior to
their participation in the clinical studies.
Clinical
Trials. Human clinical studies or testing of a potential
product prior to Federal approval are generally done in three stages known as
Phase I, Phase II, and Phase III testing. The names of the phases are
derived from the CFR 21 that regulates the FDA. Generally, there are multiple
studies conducted in each phase.
Phase I. Phase I
studies involve testing a drug or product on a limited number of
participants. Phase I studies determine a drug’s basic safety and how
the drug is absorbed by, and eliminated from, the body. This phase
lasts an average of six months to a year. Typically, cancer
therapeutics are initially tested on very late stage cancer
patients.
Phase II. Phase II
trials involve large numbers of participants at a time who may suffer from the
targeted disease or condition. Phase II testing typically lasts an
average of one to three years. In Phase II, the drug is tested to
determine its safety and effectiveness for treating a specific illness or
condition. Phase II testing also involves determining acceptable
dosage levels of the drug. If Phase II studies show that a new drug
has an acceptable range of safety risks and probable effectiveness, a company
will continue to review the substance in Phase III studies. It is
during Phase II that everything that goes into a Phase III test is
determined.
Phase III. Phase
III studies involve testing large numbers of participants, typically several
hundred to several thousand persons. The purpose is to verify
effectiveness and long-term safety on a large scale. These studies
generally last two to six years. Phase III studies are conducted at
multiple locations or sites. Like the other phases, Phase III
requires the site to keep detailed records of data collected and procedures
performed.
New Drug
Approval. The results of the clinical trials are submitted to
the FDA as part of an NDA or BLA. Following the completion of Phase
III studies, assuming the sponsor of a potential product in the U.S. believes it
has sufficient information to support the safety and effectiveness of its
product, it submits an NDA or BLA to the FDA requesting that the product be
approved for marketing. The application is a comprehensive,
multi-volume filing that includes the results of all preclinical and clinical
studies, information about the drug’s composition, and the sponsor’s plans for
producing, packaging, labeling and testing the product. The FDA’s
review of an application can take a few months to many years, with the average
review lasting 18 months. Once approved, drugs and other
products may be marketed in the U.S., subject to any conditions imposed by the
FDA.
The drug
approval process is time-consuming, involves substantial expenditures of
resources, and depends upon a number of factors, including the severity of the
illness in question, the availability of alternative treatments, and the risks
and benefits demonstrated in the clinical trials.
On
November 21, 1997, former President Clinton signed into law the FDA
Modernization Act. That act codified the FDA’s policy of granting
“Fast Track” approval for cancer therapies and other therapies intended to treat
serious or life threatening diseases and that demonstrate the potential to
address unmet medical needs. The Fast Track program emphasizes close,
early communications between the FDA and the sponsor to improve the efficiency
of preclinical and clinical development, and to reach agreement on the design of
the major clinical efficacy studies that will be needed to support
approval. Under the Fast Track program, a sponsor also has the option
to submit and receive review of parts of the NDA or BLA on a rolling schedule
approved by FDA, which expedites the review process.
The FDA’s
Guidelines for Industry Fast Track Development Programs require that a clinical
development program must continue to meet the criteria for Fast Track
designation for an application to be reviewed under the Fast Track
Program. Previously, the FDA approved cancer therapies primarily
based on patient survival rates or data on improved quality of
life. While the FDA could consider evidence of partial tumor
shrinkage, which is often part of the data relied on for approval, such
information alone was usually insufficient to warrant approval of a cancer
therapy, except in limited situations. Under the FDA’s new policy,
which became effective on February 19, 1998, Fast Track designation ordinarily
allows a product to be considered for accelerated approval through the use of
surrogate endpoints to demonstrate effectiveness. As a result of
these provisions, the FDA has broadened authority to consider evidence of
partial tumor shrinkage or other surrogate endpoints of clinical benefit for
approval. This new policy is intended to facilitate the study of
cancer therapies and shorten the total time for marketing
approvals. Under accelerated approval, the manufacturer must continue
with the clinical testing of the product after marketing approval to validate
that the surrogate endpoint did predict meaningful clinical
benefit. To the extent applicable we intend to take advantage of the
Fast Track programs to obtain accelerated approval on our future products,
however, it is too early to tell what effect, if any, these provisions may have
on the approval of our product candidates.
Other
Regulations
Various
Federal and state laws, regulations, and recommendations relating to safe
working conditions, laboratory practices, the experimental use of animals, and
the purchase, storage, movements, import, export, use, and disposal of hazardous
or potentially hazardous substances, including radioactive compounds and
infectious disease agents, are used in connection with our research or
applicable to our activities. They include, among others, the U.S.
Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational
Safety and Health Act, the National Environmental Policy Act, the Toxic
Substances Control Act, and Resources Conservation and Recovery Act, national
restrictions on technology transfer, import, export, and customs regulations,
and other present and possible future local, state, or federal
regulation. The extent of governmental regulation which might result
from future legislation or administrative action cannot be accurately
predicted.
There is
a series of international harmonization treaties, known as the ICH treaties that
enable drug development to be conducted on an international
basis. These treaties specify the manner in which clinical trials are
to be conducted, and if trials adhere to the specified requirements, then they
are accepted by the regulatory bodies of in the signatory
countries. In this way the Advaxis Phase I study conducted outside of
the U.S. is accepted by the FDA.
Manufacturing
The FDA
requires that any drug or formulation to be tested in humans be manufactured in
accordance with its GMP regulations. This has been extended to
include any drug which will be tested for safety in animals in support of human
testing. The GMPs set certain minimum requirements for procedures,
record-keeping, and the physical characteristics of the laboratories used in the
production of these drugs.
We have
entered into a Long Term Vaccine Supply Agreement with Cobra for the purpose of
manufacturing our vaccines. Cobra has extensive experience in
manufacturing gene therapy products for investigational
studies. Cobra is a full service manufacturing organization that
manufactures and supplies DNA-based therapeutics for the pharmaceutical and
biotech industry. These services include the GMP manufacturing of
DNA, recombinant protein, viruses, mammalian cells products and cell
banking. Cobra’s manufacturing plan for us calls for several
manufacturing stages, including process development, manufacturing of non-GMP
material for toxicology studies and manufacturing of GMP material for the Phase
I and Phase II trials.
We have
entered into a GMP compliant filing of ADXS11-001 agreement with Vibalogics
GmbH, Zeppelinstr. 2, 27472 Cuxhaven, Germany to fill up to 5,000
vials of our clinical supplies. This agreement was for €84,800 and is
near completion in preparation for our Phase II CIN trial.
Competition
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. As a
result, our actual or proposed products could become obsolete before we recoup
any portion of our related research and development and commercialization
expenses. The biotechnology and biopharmaceutical industries are
highly competitive, and this competition comes from both biotechnology firms and
from major pharmaceutical and chemical companies, including Antigenics, Inc.,
Avi BioPharma, Inc., Biomira, Inc., Cellgenesis Inc., Biovest International,
Cell Genesys, Inc., Dendreon Corporation, Pharmexa-Epimmune, Inc., Genzyme
Corp., Progenics Pharmaceuticals, Inc., and Vical Incorporated each of which is
pursuing cancer vaccines. Many of these companies have substantially
greater financial, marketing, and human resources than we do (including, in some
cases, substantially greater experience in clinical testing, manufacturing, and
marketing of pharmaceutical products). We also experience competition
in the development of our products from universities and other research
institutions and compete with others in acquiring technology from such
universities and institutions. In addition, certain of our products
may be subject to competition from products developed using other technologies,
some of which have completed numerous clinical trials.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector. Our competition will be determined
in part by the potential indications for which drugs are developed and
ultimately approved by regulatory authorities. Additionally, the
timing of market introduction of some of our potential products or of
competitors’ products may be an important competitive
factor. Accordingly, the speed with which we can develop products,
complete preclinical testing, clinical trials and approval processes and supply
commercial quantities to market are expected to be important competitive
factors. We expect that competition among products approved for sale
will be based on various factors, including product efficacy, safety,
reliability, availability, price and patent position.
Merck has
developed the drug Gardasil and GSK has developed the drug Cervarix which can
prevent cervical cancer by vaccinating women against the virus HPV, the cause of
the disease. Gardasil is directed against four HPV species while
Cervarix is directed against two. Neither of these agents have an
approved indication for women who have a prior exposure to the HPV strains that
they protect against, nor are women protected from other strains of HPV that the
drugs do not treat. It has been written that these are cancer
vaccines, which is not true. They are anti-virus vaccines intended to
protect against strains of the HPV virus.
The
presence of these agents in the market does not eliminate the market for a
therapeutic vaccine directed against invasive cervical cancer and CIN for a
number of reasons:
HPV is
the most common sexually treated disease in the U.S., and since prior exposure
to the virus renders these anti-viral agents ineffective they tend to be limited
to younger women and do not offer protection for women who are already
infected. This is estimated to be as much as (or more than) 25% of
the female population of the U.S.
There are
believed to be approximately 10 high risk species of HPV, but these agents only
protect against the most common 2-4 strains. If a woman contracts a
high risk HPV species that is not one of those the drugs will not
work.
Women
with HPV are typically infected for over twenty years or more before they
manifest cervical cancer. Thus, the true prophylactic effect of these
agents can only be inferred at this time. We believe that there
currently exists a significant population of young woman who have not received
these agents, or for whom they will not work, and who will manifest HPV related
cervical disease for the next 40+ years. We believe this population will
continue to grow until such time as a significant percentage of women who have
not been exposed to HPV are vaccinated; which we believe is not likely to occur
within the next decade or longer. We do not know at this time whether
a significant number of women will be vaccinated to have an effect on the
epidemiology of this disease. Currently, men are not
vaccinated.
With the
exception of the campaign to eradicate polio in which vaccination was mandatory
for all school age children, vaccination is a difficult model to accomplish
because it is virtually impossible to treat everyone in any given country, much
less the entire world. This is especially true for cervical cancer as
the incentive for men to be vaccinated is small, and infected men keep the
pathogen circulating in the population.
Taken
together, experts believe that there will be a cervical cancer and CIN market
for the foreseeable future.
Scientific
Advisory Board
We
maintain a Scientific Advisory Board consisting of internationally recognized
scientists who advise us on scientific and technical aspects of our
business. The Scientific Advisory Board meets on an as needed basis
to review specific projects and to assess the value of new technologies and
developments to us. In addition, individual members of the scientific
advisory board meet with us periodically to provide advice in particular areas
of expertise. The scientific advisory board consists of the following
members, information with respect to whom is set forth below: Yvonne Paterson,
Ph.D.; Carl June, M.D.; Pramod Srivastava, Ph.D.; Bennett Lorber, M.D.; David
Weiner, Ph.D.; and Mark Einstein, M.D.
Dr. Yvonne
Paterson. For a description of our relationship with Dr.
Paterson, please see “Partnerships and Agreements-Dr. Yvonne
Paterson.”
Carl June,
M.D. Dr. June is currently Facility Director, Human Immunology
Center and Professor, Pathology and Laboratory Medicine Translational Research
at the Abramson Cancer Center at Penn, and previously a Director of
Translational Research at the Center and Investigator of the Abramson Family
Cancer Research Institute. He is a graduate of the Naval Academy in
Annapolis, and Baylor College of Medicine in Houston. He had graduate
training in immunology and malaria with Dr. Paul-Henri Lambert at the World
Health Organization, Geneva, Switzerland from 1978 to 1979, and post-doctoral
training in transplantation biology with Dr. E. Donnell Thomas at the Fred
Hutchinson Cancer Research Center in Seattle from 1983 to 1986. He is
board certified in Internal Medicine and Medical Oncology. Dr. June
founded the Immune Cell Biology Program and was head of the Department of
Immunology at the Naval Medical Research Institute from 1990 to
1995. Dr. June rose to Professor in the Departments of Medicine and
Cell and Molecular Biology at the Uniformed Services University for the Health
Sciences in Bethesda, Maryland before assuming his current positions as of
February 1, 1999. Dr. June maintains a research laboratory that
studies various mechanisms of lymphocyte activation that relate to immune
tolerance and adoptive immunotherapy.
Pramod Srivastava, Ph.D. Dr.
Srivastava is Professor of Immunology at the University of Connecticut School of
Medicine, where he is also Director of the Center for Immunotherapy of Cancer
and Infectious Diseases. He holds the Physicians Health Services
Chair in Cancer Immunology at the University of Connecticut School of
Medicine. Professor Srivastava is the Scientific Founder of
Antigenics, Inc. He serves on the Scientific Advisory Council of the
Cancer Research Institute, New York, and was a member of the Experimental
Immunology Study Section of the National Institutes of Health of the U.S.
Government from 1994 to 1999. He serves presently on the board of
directors of two privately held companies: Ikonisys, in New Haven, Connecticut
and CambriaTech, Lugano, Switzerland. In 1997, he was inducted into
the Roll of Honor of the International Union Against Cancer and was listed in
Who’s Who in Science and Engineering. He is among the twenty founding
members of the Academy of Cancer Immunology, New York. Dr. Srivastava
obtained his bachelor’s degree in biology and chemistry and a master’s degree in
botany (paleontology) from the University of Allahabad, India. He then studied
yeast genetics at Osaka University, Japan. He completed his Ph.D. in
biochemistry at the Center for Cellular and Molecular Biology, Hyderabad, India,
where he began his work on tumor immunity, including identification of the first
proteins that can mediate tumor rejection. He trained at Yale
University and Sloan-Kettering Institute for Cancer Research. Dr.
Srivastava has held faculty positions at the Mount Sinai School of Medicine and
Fordham University in New York City.
Bennett Lorber,
M.D. Dr. Lorber attended Swarthmore College where he studied
zoology and art history. He graduated from the University of
Pennsylvania School of Medicine and did his residency in internal medicine and
fellowship in infectious diseases at Temple University, following which he
joined the Temple faculty. At Temple he rose through the ranks to
become Professor of Medicine and, in 1988, was named the first recipient of the
Thomas Durant Chair in Medicine. He is also a Professor of
Microbiology and Immunology and served as the Chief of the Section of Infectious
Diseases until 2006. He is a Fellow of the American College of
Physicians, a Fellow of the Infectious Diseases Society of America, and a Fellow
of the College of Physicians of Philadelphia where he serves as College
Secretary and as a member of the Board of Trustees. Dr. Lorber’s
major interest in infectious diseases is in human listeriosis, an area in which
he is regarded as an international authority. He has also been
interested in the impact of societal changes on infectious disease patterns as
well the relationship between infectious agents and chronic illness, and he has
authored papers exploring these associations. He has been repeatedly
honored for his teaching. Among his honors are 10 golden apples, the
Temple University Great Teacher Award, the Clinical Practice Award from the
Pennsylvania College of Internal Medicine, and the Bristol Award from the
Infectious Diseases Society of America. In 1996 he was the recipient
of an honorary Doctor of Science degree from Swarthmore College.
David B. Weiner,
Ph.D. Dr. David Weiner received his B.S in Biology from the
State University of New York and performed undergraduate research in the
Department of Microbiology, Chaired by Dr. Arnie Levine, at Stony Brook
University. He completed his MS and Ph.D. in Developmental
Biology/Immunology from the Children’s Hospital Research Foundation at the
University of Cincinnati in 1986. He completed his Post Doctoral
Fellowship in the Department of Pathology at Penn in 1989, under the direction
of Dr. Mark Greene. At that time he joined the Faculty at the Wistar
Institute in Philadelphia. He was recruited back to Penn in 1994. He
is currently an Associate Professor with Tenure in the Department of Pathology,
and he is the Associate Chair of the Gene Therapy and Vaccines Graduate Program
at Penn. Of relevance during his career he has worked extensively in
the areas of molecular immunology, the development of vaccines and vaccine
technology for infectious diseases and in the area of molecular oncology and
immune therapy. His laboratory is considered one of the founders of
the field of DNA vaccines as his group not only was the first to report on the
use of this technology for vaccines against HIV, but was also the first group to
advance DNA vaccine technology to clinical evaluation. In addition he
has worked on the identification of novel approaches to inhibit HIV infection by
targeting the accessory gene functions of the virus. Dr. Weiner has
authored over 260 articles in peer reviewed journals and is the author of over
28 awarded U.S. patents as well as their international
counterparts. He has served and still serves on many national and
international review boards and panels including the NIH Study section, WHO
advisory panels, the National Institute for Biological Standards and Control,
Department of Veterans Affairs Scientific Review Panel, as well as the FDA
Advisory panel - Center for Biologics Evaluation and Research, and Adult AIDS
Clinical Trial Group, among others. He also serves or has served in
an advisory capacity to several Biotechnology and Pharmaceutical
Companies. Dr. Weiner has, through training of young people in his
laboratory, advanced over 35 undergraduate scientists to Medical School or
Doctoral Programs and has trained 28 Post Doctoral Fellows and 7 Doctoral
Candidates as well as served on fourteen Doctoral Student
Committees.
Mark Einstein,
M.D. Dr. Einstein received his BS degree in Biology from the
University of Miami, where he also received his MD with Research Distinction in
Clinical Immunology. He also has an MS in Clinical Research Methods,
which he received with Distinction. Dr. Einstein completed his
residency in OB/GYN at Saint Barnabas Medical Center, and was a Galloway Fellow
in Gynecologic Oncology at the Sloan-Kettering Cancer Center. Dr.
Einstein has been at the Albert Einstein Cancer Center and Montefiore Medical
Center since 1999, where he has been an attending physician, Assistant Professor
of Gynecologic Oncology, and currently the Director of Clinical Research of the
Division of Gynecologic Oncology at the Albert Einstein College of Medicine and
Cancer Center, and at the Montefiore Medical Center. He is a Fellow
of the American College of Obstetrics and Gynecology and the American College of
Surgeons, as well as belonging to various research groups such as the American
Association for Cancer Research and the American Society for Clinical
Oncology. Dr. Einstein’s honors and awards include; American Cancer
Society Research Scholar, American Professors in Gynecology and Obstetrics
McNeil Faculty Award, ACOG/3M Research Award, ACOG/Solvay Research Award, Berlex
Oncology Foundation Scholar Award, and others. Dr. Einstein is a
member of the GOG Vaccine subcommittee, chairs the Gynecologic Cancer Foundation
National Cervical Cancer Education Campaign, sits on the Translational Research
Working Group Roundtable at NIH/NCI, the NHI AIDS malignancy Consortium, the
Gynecologic Cancer Foundation Task Force for Cervical Cancer Screening and
Prevention, as well as three separate committees for the Society of Gynecologic
Oncologists. Dr. Einstein is very active in the clinical assessment
of new immunological technologies for the treatment of gynecologic
cancers.
Employees
As of
November 1, 2009, we had nine full time employees. Of these
employees, eight employees hold the following degrees: one MD/JD, one
MD/PhD, two PhD’s, one MS & three BS’s, three serve in the research
area, two serve in the clinical/regulatory development area and four serve in
the general and administration area.
We do not
anticipate any significant increase in the number of employees in the clinical
area and the research and development area to support clinical requirements, and
in the general and administrative and business development areas over the next
two years.
Description
of Property
Our
corporate offices are currently located at a biotech industrial park located at
675 Route 1, North Brunswick, NJ 08902. Our current Lease Amendment
Agreement dated as of March 1, 2008 with the NJEDA will continue on a monthly
basis for two research and development laboratory units (total of 1,600 s.f.)
and one office (total of 655 s.f.). We believe our facility will be
sufficient for our near term purposes and the facility offers additional space
for the foreseeable future. Our monthly payment on this facility is
approximately $6,286 per month. In the event that our facility
should, for any reason, become unavailable, we believe that alternative
facilities are available at competitive rates.
Legal
Proceedings
As of the
date hereof, there are no material legal proceedings threatened against
us. In the ordinary course of our business we may become subject to
litigation regarding our products or our compliance with applicable laws, rules,
and regulations.
MANAGEMENT
Executive
Officers, Directors and Key Employees
The
following are our executive officers and directors and their respective ages and
positions as of October 1, 2009:
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
Thomas
A. Moore
|
|
58
|
|
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
|
Fredrick
D. Cobb
|
|
62
|
|
Vice
President, Finance and Principal Financial Officer
|
Christopher
C. Duignan
|
|
34
|
|
Senior
Vice President of
Finance
|
Thomas A.
Moore. Effective December 15, 2006, Mr. Moore was appointed
our Chairman and Chief Executive Officer. He is currently also a
director of MD Offices, an electronic medical records provider, and Opt-e-scrip,
Inc., which markets a clinical system to compare multiple drugs in the same
patient. He also serves as Chairman of the board of directors of
Mayan Pigments, Inc., which has developed and patented Mayan pigment
technology. Previously, from June 2002 to June 2004 Mr. Moore was
President and Chief Executive Officer of Biopure Corporation, a developer of
oxygen therapeutics that are intravenously administered to deliver oxygen to the
body’s tissues. From 1996 to November 2000 he was President and Chief
Executive Officer of Nelson Communications. Prior to 1996, Mr. Moore
had a 23-year career with the Procter & Gamble Company in multiple
managerial positions, including President of Health Care Products where he was
responsible for prescription and over-the-counter medications worldwide, and
Group Vice President of the Procter & Gamble Company.
Mr. Moore
is subject to a five year injunction, which came about because of a civil action
captioned Securities &
Exchange Commission v. Biopure Corp. et al., No. 05-11853-PBS (D. Mass.),
filed on September 14, 2005, which alleged that Mr. Moore made and approved
misleading public statements about the status of FDA regulatory proceedings
concerning a product manufactured by his former employer, Biopure
Corp. Mr. Moore vigorously defended the action. On
December 11, 2006, the SEC and Mr. Moore jointly sought a continuance of all
proceedings based upon a tentative agreement in principle to settle the SEC
action. The SEC’s Commissioners approved the terms of the settlement,
and the court formally adopted the settlement.
Dr. James
Patton. Dr. Patton has served as a member of our board of
directors since February 2002, as Chairman of our board of directors from
November 2004 until December 31, 2005 and as Advaxis’ Chief Executive Officer
from February 2002 to November 2002. Since February 1999, Dr. Patton
has been the Vice President of Millennium Oncology Management, Inc., which
provides management services for radiation oncology care to four
sites. In addition, he has been President of Comprehensive Oncology
Care, LLC since 1999, a company which owned and operated a cancer treatment
facility in Exton, Pennsylvania until its sale in 2008. From February
1999 to September 2003, Dr. Patton also served as a consultant to LibertyView
Equity Partners SBIC, LP, a venture capital fund based in Jersey City, New
Jersey. From July 2000 to December 2002, Dr. Patton served as a
director of Pinpoint Data Corp. From February 2000 to November 2000, Dr. Patton
served as a director of Healthware Solutions. From June 2000 to June
2003, Dr. Patton served as a director of LifeStar Response. He earned
his B.S. from the University of Michigan, his Medical Doctorate from Medical
College of Pennsylvania, and his M.B.A. from Penn’s Wharton
School. Dr. Patton was also a Robert Wood Johnson Foundation Clinical
Scholar. He has published papers regarding scientific research in
human genetics, diagnostic test performance and medical economic
analysis.
Roni A.
Appel. Mr. Appel has served as a member of our board of
directors since November 2004. He was President and Chief Executive
Officer from January 1, 2006 and Secretary and Chief Financial Officer from
November 2004, until he resigned as our Chief Financial Officer on September 7,
2006 and as our President, Chief Executive Officer and Secretary on December 15,
2006. He has provided consulting services to us through LVEP
Management, LLC, since January 19, 2005. From 1999 to 2004, he has
been a partner and managing director of LV Equity Partners (f/k/a LibertyView
Equity Partners). From 1998 until 1999, he was a director of business
development at Americana Financial Services, Inc. From 1994 to 1998
he was an attorney and completed his MBA at Columbia University.
Dr. Thomas
McKearn. Dr. McKearn has served as a member of our board of
directors since July 2002. He brings to us a 25 plus year experience
in the translation of biotechnology science into oncology
products. First as one of the founders of Cytogen Corporation, then
as an Executive Director of Strategic Science and Medicine at Bristol-Myers
Squibb and now as the VP of Strategic Medical Affairs at GPC-Biotech, he has
worked at bringing the most innovative laboratory findings into the clinic and
through the FDA regulatory process for the benefit of cancer patients who need
better ways to cope with their afflictions. Prior to entering the
biotechnology industry in 1981, Dr. McKearn did his medical, graduate and
post-graduate training at the University of Chicago and served on the faculty of
the Medical School at the University of Pennsylvania.
Richard
Berman. Mr. Berman has served as a member of our board of
directors since September 1, 2005. In the last five years, he served
as a professional director and/or officer of about a dozen public and private
companies. He is currently Chairman of NexMed, Inc., a public biotech
company, and National Investment Managers. Mr. Berman is a director
of six public companies: Broadcaster, Inc., Easy Link Services International,
Inc., NexMed, Inc., National Investment Managers, Advaxis, Inc., and NeoStem,
Inc. Previously, Mr. Berman worked at Goldman Sachs and was Senior
Vice President of Bankers Trust Company, where he started the M&A and
Leverage Buyout Departments. He is a past Director of the Stern
School of Business of New York University, where he earned a B.S. and an M.B.A.
He also has law degrees from Boston College and The Hague Academy of
International Law.
John Rothman,
Ph.D. Dr. Rothman joined our company in March 2005 as Vice
President of Clinical Development and as of December 12, 2008 he was appointed
to Executive Vice President of Clinical and Scientific
Operations. From 2002 to 2005, Dr. Rothman was Vice President and
Chief Technology Officer of Princeton Technology Partners. Prior to
that he was involved in the development of the first interferon at Schering
Inc., was director of a variety of clinical development sections at Hoffman
LaRoche, and the Senior Director of Clinical Data Management at
Roche. While at Roche his work in Kaposi’s Sarcoma became the
clinical basis for the first filed BLA which involved the treatment of AIDS
patients with interferon.
Fredrick D.
Cobb. Mr. Cobb joined our company in February 2006 as the Vice
President of Finance and on September 7, 2006 was appointed Principal Financial
Officer (PFO) and Assistant Secretary. He was the PFO and Corporate
Controller for Metaphore Pharmaceuticals Inc., a private company, from June 2004
to December 2005 and PFO and Corporate Controller at the public company
Emisphere Technologies, Inc. from 2001 until 2004. Prior thereto he
served as Vice President and Chief Financial Officer at MetaMorphix, Inc. from
1997 to 2000. Formerly Mr. Cobb served as Group Director of Bristol
Myers-Squibb Science and Technology Group, where he had a twelve-year career in
senior financial roles. Mr. Cobb received an M.S. in Accounting from
Seton Hall University in 1997 and holds a B.S. degree in Management from Cornell
University.
Christopher C.
Duignan. Mr. Duignan joined our company in September 2009 as the Senior
Vice President of Finance. He was the Chief Financial Officer of
Enliven Marketing Technologies Corporation from November 2006 until the company
was sold in October 2008. Mr. Duignan worked for Enliven Marketing
Technologies Corporation from January 2002 to November 2008, during which time
he served as Assistant Controller, Controller, Chief Accounting Officer, and
Chief Financial Officer. Prior to Enliven Marketing Technologies Corporation,
Mr. Duignan worked at PricewaterhouseCoopers LLP from September 1997 to October
2001 in their technology group within the audit practice. At
PricewaterhouseCoopers LLP, Mr. Duignan’s client base consisted of publicly
traded technology companies as well as start-ups. Mr. Duignan received a B.S. in
Accounting from Fairfield University in 1997 and is a Certified Public
Accountant.
Board
of Directors
Each
director is elected for a period of one year and serves until the next annual
meeting of stockholders, or until his or her successor is duly elected and
qualified. Officers are elected by, and serve at the discretion of, our board of
directors. The board of directors may also appoint additional directors up to
the maximum number permitted under our by-laws, which is currently
nine.
Committees
of the Board of Directors
Our board
of directors has three standing committees: the audit committee, the
compensation committee, and the nominating and corporate governance
committee.
Audit
Committee
The audit
committee of our board of directors consists of Mr. Berman and Dr. Patton with
Mr. Berman serving as the audit committee’s financial expert as defined under
Item 407 of Regulation S-K of the Securities Act of 1933, as amended, which we
refer to as the Securities Act. Our board of directors has determined that the
audit committee financial expert is independent as defined in (i) Rule
10A-3(b)(i)(ii) under the Exchange Act and (ii) under Section 121 B(2)(a) of the
NYSE Amex Equities Company Guide (although our securities are not listed on the
NYSE Amex Equities but are quoted on the OTC Bulletin Board).
The audit
committee is responsible for the following:
|
·
|
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.
|
Compensation
Committee
The
compensation committee of our board of directors consists of Mr. Berman and Dr.
McKearn. The compensation committee determines the salaries and
incentive compensation of our officers subject to applicable employment
agreements, and provides recommendations for the salaries and incentive
compensation of our other employees and consultants.
Nominating
and Corporate Governance Committee
The
nominating and corporate governance committee of our board of directors consists
of Mr. Berman and Mr. Moore. The functions of the nominating and corporate
governance committee include the following:
|
·
|
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.
|
The
nominating and corporate governance committee will be governed by a charter,
which we intend to adopt.
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The
following table sets forth the information as to compensation paid to or earned
by our Chief Executive Officer and our two other most highly compensated
executive officers during the fiscal years ended October 31, 2007 and
2008. These individuals are referred to in this prospectus as our
named executive officers. As none of our named executive officers
received non-equity incentive plan compensation or nonqualified deferred
compensation earnings during the fiscal years ended October 31, 2007 and 2008,
we have omitted those columns from the table.
Name and
Principal
Position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thomas A.
Moore,
|
|
2008
|
|
$ |
352,692 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
156,364 |
|
|
$ |
27,626 |
(2) |
|
$ |
536.682 |
|
CEO
and Chairman
|
|
2007
|
|
|
220,769 |
|
|
|
— |
|
|
|
172,500 |
|
|
|
129,813 |
|
|
|
23,976 |
(2) |
|
|
547,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
John Rothman,
|
|
2008
|
|
|
255,000 |
|
|
|
55,000 |
|
|
|
23,378 |
(3) |
|
|
25,092 |
|
|
|
27,862 |
(4) |
|
|
386,332 |
|
Executive
VP of Science & Operations
|
|
2007
|
|
|
173,923 |
|
|
|
45,000 |
|
|
|
44,497 |
(5) |
|
|
23,128 |
|
|
|
27,497 |
(4) |
|
|
314,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fredrick
D. Cobb,
|
|
2008
|
|
|
182,923 |
|
|
|
40,000 |
|
|
|
15,585 |
(6) |
|
|
19,977 |
|
|
|
7,136 |
(7) |
|
|
265,621 |
|
VP
Finance
|
|
2007
|
|
|
144,731 |
|
|
|
28,000 |
|
|
|
22,353 |
(8) |
|
|
13,863 |
|
|
|
9,358 |
(7) |
|
|
218,305 |
|
|
(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 our cost of his coverage for health care and the payment of interest
earned on his loans to us.
|
|
(3)
|
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 196,339 shares earned, but not
issued.
|
|
(4)
|
Based
on our cost of his coverage for health care and the 401K company match he
received.
|
|
(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 44,945 shares earned, but not
issued.
|
|
(6)
|
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.
|
|
(7)
|
Based
on our cost of the 401K company match he
received.
|
|
(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 29,964 shares earned, but not
issued.
|
Discussion
of Summary Compensation Table
We are
party to an employment agreement with each of our named executive officers who
is presently employed by us. Each employment agreement sets forth the
terms of that officer’s employment, including among other things, salary, bonus,
non-equity incentive plan and other compensation, and its material terms are
described below. In fiscal 2007 and fiscal 2008, we granted stock
options to our named executive officers to purchase shares of our common stock
and issued stock to our Chief Executive Officer. The material terms
of these grants are also described below.
Moore Employment Agreement and
Option Agreements. We are party to an employment agreement
with Mr. Moore, dated as of August 21, 2007 (memorializing an oral agreement
dated December 15, 2006), that provides that he will serve as our Chairman of
the Board and Chief Executive Officer for an initial term of two
years. For so long as Mr. Moore is employed by us, Mr. Moore is also
entitled to nominate one additional person to serve on our board of
directors. Following the initial term of employment, the agreement
was renewed for a one year term, and is automatically renewable for additional
successive one year terms, subject to our right and Mr. Moore’s right not to
renew the agreement upon at least 90 days’ written notice prior to the
expiration of any one year term.
Under the
terms of the agreement, Mr. Moore was entitled to receive a base salary of
$250,000 per year, subject to increase to $350,000 per year upon our successful
raise of at least $4.0 million (which condition was satisfied on November 1,
2007) and subject to annual review for increases by our board of directors in
its sole discretion. The agreement also provides that Mr. Moore is
entitled to receive family health insurance at no cost to him. Mr.
Moore’s employment agreement does not provide for the payment of a
bonus.
In
connection with our hiring of Mr. Moore, we agreed to grant Mr. Moore up to
1,500,000 shares of our common stock, of which 750,000 shares were issuable on
November 1, 2007 upon our successful raise of $4.0 million and 750,000 shares
are issuable upon our successful raise of an additional $6.0
million. As of November 6, 2009, we have raised approximately $5.4
million of this $6.0 million milestone. In addition, on December 15,
2006, we granted Mr. Moore options to purchase 2,400,000 shares of our common
stock. Each option is exercisable at $0.143 per share (which was
equal to the closing sale price of our common stock on December 15, 2006) and
expires on December 15, 2011. The options vest in 24 equal monthly
installments. We have also agreed to grant Mr. Moore options to
purchase an additional 1,500,000 shares of our common stock if the price of
common stock (adjusted for any splits) is equal to or greater than $0.40 for 40
consecutive business days. Pursuant to the terms of his employment
agreement, all options will be awarded and vested upon a merger of the company
which is a change of control or a sale of the company while Mr. Moore is
employed. In addition, if Mr. Moore’s employment is terminated by us,
Mr. Moore is entitled to receive severance payments equal to one year’s salary
at the then current compensation level.
Mr. Moore
has agreed to refrain from engaging in certain activities that are competitive
with us and our business during his employment and for a period of 12
months thereafter under certain circumstances. In addition, Mr. Moore
is subject to a non-solicitation provision for 12 months after termination of
his employment.
Rothman Employment Agreement and
Option Agreements. We previously entered into an employment
agreement with Dr. Rothman, Ph.D., dated as of March 7, 2005, that provided that
he would serve as our Vice President of Clinical Development for an initial
term of one year. Dr. Rothman’s current salary is $280,000,
consisting of $250,000 in cash and $30,000 in stock, payable in our common
stock, issued on a semi-annual basis, based on the average closing stock price
for such six month period, with a minimum price of $0.20. While the
employment agreement has expired and has not been formally renewed in accordance
with the agreement, Dr. Rothman remains employed by us and is currently our
Executive V.P. of Clinical and Scientific Operations.
In
addition, on March 1, 2005, we granted Dr. Rothman options to purchase 360,000
shares of our common stock. Each option is exercisable at $0.287 per
share (which was equal to the closing sale price of our common stock on March 1,
2005) and expires on March 1, 2015. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. On March
29, 2006, we granted Dr. Rothman options to purchase 150,000 shares of our
common stock. Each option is exercisable at $0.26 per share (which
was equal to the closing sale price of our common stock on March 29, 2006) and
expires on March 29, 2016. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. On February
15, 2007, we granted Dr. Rothman options to purchase 300,000 shares of our
common stock. Each option is exercisable at $0.165 per share (which
was equal to the closing sale price of our common stock on February 15, 2007)
and expires on February 15, 2017. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. Pursuant to
the terms of the 2005 plan, at least 75% of Dr. Rothman’s options will be vested
upon a merger of the company which is a change of control or a sale of the
company while Dr. Rothman is employed, unless the administrator of the plan
otherwise allows for all options to become vested.
Dr.
Rothman has agreed to refrain from engaging in certain activities that are
competitive with us and our business during his employment and for a period
of 18 months thereafter under certain circumstances. In
addition, Dr. Rothman is subject to a non-solicitation provision for 18
months after termination of his employment.
Cobb Employment Agreement and Option
Agreements. We entered into an employment agreement
with Mr. Cobb, dated as of February 20, 2006, that provided that he would serve
as our Vice President of Finance. Mr. Cobb’s current salary is
$200,000, consisting of $180,000 in cash and $20,000 in stock, payable in our
common stock, issued on a semi-annual basis, based on the average closing stock
price for such six month period, with a minimum price of $0.20.
In
addition, on February 20, 2006, we granted Mr. Cobb options to purchase 150,000
shares of our common stock. Each option is exercisable at $0.26 per share (which
was equal to the closing sale price of our common stock on February 20, 2006)
and expires on February 20, 2016. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. On September 21, 2006,
we granted Mr. Cobb options to purchase 150,000 shares of our common stock. Each
option is exercisable at $0.16 per share (which was equal to the closing sale
price of our common stock on September 21, 2006) and expires on September 21,
2016. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. On February 15, 2007,
we granted Mr. Cobb options to purchase 150,000 shares of our common
stock. Each option is exercisable at $0.165 per share (which was equal to
the closing sale price of our common stock on February 15, 2007) and expires on
February 15, 2017. One-fourth
of the these options vest on the first anniversary of the grant date, and the
remaining vest in 12 equal quarterly installments. Pursuant to the
terms of the 2005 plan, at least 75% of Mr. Cobb’s options will be vested upon a
merger of the company which is a change of control or a sale of the company
while Mr. Cobb is employed, unless the administrator of the plan otherwise
allows for all options to become vested.
Mr. Cobb
has agreed to refrain from engaging in certain activities that are competitive
with us and our business during his employment and for a period of 18 months
thereafter under certain circumstances. In addition, Mr. Cobb is subject to a
non-solicitation provision for 18 months after termination of his
employment.
Outstanding
Equity Awards at Fiscal Year-End
The
following table provides information about the number of outstanding equity
awards held by our named executive officers at October 31,
2008.
|
|
Option Awards
|
|
Stock Awards
|
|
Name
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
|
Equity
Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
|
|
Option
Exercise
Price ($)
|
|
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
|
|
|
2,200,000 |
|
|
|
200,000 |
(1) |
|
|
— |
|
|
|
0.143 |
|
12/15/16
|
|
|
750,000 |
(2) |
|
$ |
30,000 |
(3) |
|
|
— |
|
|
|
— |
|
Dr.
John Rothman
|
|
|
315,000 |
|
|
|
45,000 |
(3) |
|
|
— |
|
|
|
0.287 |
|
3/1/15
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
93,750 |
|
|
|
56,250 |
(4) |
|
|
— |
|
|
|
0.260 |
|
3/29/16
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
112,500 |
|
|
|
187,500 |
(5) |
|
|
— |
|
|
|
0.165 |
|
2/15/17
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Fredrick
D. Cobb (5)
|
|
|
93,750 |
|
|
|
56,250 |
(6) |
|
|
— |
|
|
|
0.260 |
|
2/20/16
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
75,000 |
|
|
|
75,000 |
(7) |
|
|
— |
|
|
|
0.160 |
|
9/21/16
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
56,250 |
|
|
|
93,750 |
(8) |
|
|
— |
|
|
|
0.165 |
|
2/15/17
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(1)
|
Of
these options, 100,000 became exercisable on each of November 15, 2008 and
December 15, 2008.
|
|
(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
issuable on November 1, 2007 upon our successful raise of $4.0 million and
750,000 shares are issuable upon our successful raise of an additional
$6.0 million.
|
|
(3)
|
Based
on the closing sale price of $0.04 per share of common stock on October
31, 2008 (the last day of our fiscal
year).
|
|
(4)
|
Of
these options, 22,500 became exercisable on each of December 1, 2008 and
March 1, 2009.
|
|
(5)
|
Of
these options, 9,375 became exercisable on each of December 29, 2008,
March 29, 2009, June 29, 2009 and September 29, 2009 and 9,375 become
exercisable on each of December 29, 2009 and March 29,
2010.
|
|
(6)
|
Of
these options, 18,750 became exercisable on each of November 15, 2008,
February 15, 2009, May 15, 2009 and August 15, 2009 and 18,750 become
exercisable on each November 15, February 15, May 15 and August 15 of each
year until February 15, 2011.
|
|
(7)
|
Of
these options, 9,375 became exercisable on each of November 20, 2008,
February 20, 2009, May 20, 2009 and August 20, 2009 and 9,375 become
exercisable on each of November 20, 2009 and February 20,
2010.
|
|
(8)
|
Of
these options, 9,375 became exercisable on each of December 21, 2008,
March 21, 2009, June 21, 2009 and September 21, 2009 and 9,375 become
exercisable on December 21, 2009, March 21, 2010, June 21, 2010 and
September 21, 2010.
|
|
(9)
|
Of
these options, 9,375 became exercisable on each November 15, 2008,
February 15, 2009, May 15, 2009 and August 15, 2009 and 9,375 become
exercisable on each November 15, February 15, May 15 and August 15 of each
year until February 15, 2011.
|
Director
Compensation
With the
exception of Mr. Berman, who receives $2,000 a month in shares of our common
stock based on the average closing price of our common stock for the preceding
month, none of our directors receive any compensation for his services as a
director other than options to purchase shares of our common stock and
reimbursement of expenses. Each director is granted options to
purchase shares of our common stock upon joining our board of directors and as
the compensation committee so directs.
All of
our other non-employee directors receive a combination of cash compensation and
awards of share of our common stock. Each non-employee directors
receives $2,000 for each board meeting attended in person and $750 for each
telephonic board meeting. In addition, each member of a committee of
our board of directors receives $2,000 per meeting attended in person held on
days other than board meeting days and $750 for each telephonic committee
meeting. This plan is contingent upon stockholder approval at our
next annual meeting.
The table
below summarizes the compensation that we paid to our non-employee directors for
the fiscal year ended October 31, 2008. As none of our non-employee
directors received non-equity incentive plan compensation or nonqualified
deferred compensation earnings during the fiscal year ended October 31, 2008, we
have omitted those columns from the table.
|
|
Fees
Earned
or Paid
in Cash
($)
|
|
|
Stock
Awards
($)
|
|
|
Option
Awards
($)
|
|
|
All other
Compensation
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Roni
A. Appel
|
|
$ |
1,500 |
|
|
$ |
240 |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
1,740 |
|
Dr.
James Patton
|
|
|
8,250 |
|
|
|
6,000 |
(1) |
|
|
— |
|
|
|
— |
|
|
|
14,250 |
|
Dr.
Thomas McKearn
|
|
|
7,500 |
|
|
|
6,000 |
(1) |
|
|
11,424 |
(2) |
|
|
— |
|
|
|
24,924 |
|
Martin R.
Wade III*
|
|
|
- |
|
|
|
3,600 |
(1) |
|
|
11,424 |
(2) |
|
|
— |
|
|
|
15,024 |
|
Richard
Berman
|
|
|
2,250 |
|
|
|
27,247 |
(3) |
|
|
10,000 |
(4) |
|
|
— |
|
|
|
39,497 |
|
*Resigned
from our board of directors on June 30, 2008.
|
(1)
|
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.
|
|
(2)
|
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. In 2006, based on vesting of 150,000
options of our common stock granted on October 1, 2003 at a market price
of $0.1952 share. Vests quarterly over a three year period at a
fair value of $0.14 per share (Black Scholes
Model).
|
|
(3)
|
Includes
a retroactive adjustment of shares based on the average monthly closing
prices of our common stock for the $2,000 monthly compensation as compared
to the $0.50 per share or 4,000 shares per month. The total
shares issued in fiscal year 2008 was 245,844 and the total shares earned
but not issued was 192,899.
|
|
(4)
|
Based
on the vesting of 400,000 options of our common stock granted at $0.287
per share on February 1, 2005. The option vests quarterly over
four years.
|
2004
Stock Option Plan
In
November 2004, our board of directors adopted and our stockholders approved the
2004 Stock Option Plan, which we refer to as the 2004 plan. The 2004
plan provides for the grant of options to purchase up to 2,381,525 shares of our
common stock to employees, officers, directors and
consultants. Options may be either “incentive stock options” or
non-qualified options under the Federal tax laws. Incentive stock
options may be granted only to our employees, while non-qualified options may be
issued, in addition to employees, to non-employee directors and
consultants.
The 2004
plan is administered by “disinterested members” of our board of directors or the
compensation committee, who determine, among other things, the individuals who
will receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market value per share of
common stock on the date the option is granted. The per share
exercise price of our common stock subject to a non-qualified option may be
established by our board of directors, but will not, however, be less than 85%
of the fair market value per share of common stock on the date the option is
granted. The aggregate fair market value of common stock for which
any person may be granted incentive stock options which first become exercisable
in any calendar year may not exceed $100,000 on the date of grant.
No stock
option may be transferred by an optionee other than by will or the laws of
descent and distribution, and, during the lifetime of an optionee, the option
will be exercisable only by the optionee. In the event of termination
of employment or engagement other than by death or disability, the optionee will
have no more than three months after such termination during which the optionee
will be entitled to exercise the option to the extent vested at termination,
unless otherwise determined by our board of directors. Upon
termination of employment or engagement of an optionee by reason of death or
permanent and total disability, the optionee’s options remain exercisable for
one year to the extent the options were exercisable on the date of such
termination. No similar limitation applies to non-qualified
options.
We must
grant options under the 2004 plan within ten years from the effective date of
the 2004 plan. The effective date of the 2004 plan was November 12,
2004. Subject to a number of exceptions, holders of incentive stock
options granted under the 2004 plan cannot exercise these options more than ten
years from the date of grant. Options granted under the 2004 plan
generally provide for the payment of the exercise price in cash and may provide
for the payment of the exercise price by delivery to us of shares of common
stock already owned by the optionee having a fair market value equal to the
exercise price of the options being exercised, or by a combination of these
methods. Therefore, if it is provided in an optionee’s options, the
optionee may be able to tender shares of common stock to purchase additional
shares of common stock and may theoretically exercise all of his stock options
with no additional investment other than the purchase of his original
shares.
Any
unexercised options that expire or that terminate upon an employee’s ceasing to
be employed by us become available again for issuance under the 2004
plan.
2005
Stock Option Plan
In June
2006 our board of directors adopted, and on June 6, 2006 our stockholders
approved, the 2005 Stock Option Plan, which we refer to as the 2005
plan.
The 2005
plan provides for the grant of options to purchase up to 5,600,000 shares of our
common stock to employees, officers, directors and
consultants. Options may be either “incentive stock options” or
non-qualified options under the Federal tax laws. Incentive stock
options may be granted only to our employees, while non-qualified options may be
issued to non-employee directors, consultants and others, as well as to our
employees.
The 2005
plan is administered by “disinterested members” of our board of directors or the
compensation committee, who determine, among other things, the individuals who
will receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market value per share of
common stock on the date the option is granted. The per share
exercise price of our common stock subject to a non-qualified option may be
established by our board of directors, but will not, however, be less than 85%
of the fair market value per share of common stock on the date the option is
granted. The aggregate fair market value of common stock for which
any person may be granted incentive stock options which first become exercisable
in any calendar year may not exceed $100,000 on the date of grant.
Except
when agreed to by our board of directors or the administrator of the 2005 plan,
no stock option may be transferred by an optionee other than by will or the laws
of descent and distribution, and, during the lifetime of an optionee, the option
will be exercisable only by the optionee. In the event of termination
of employment or engagement other than by death or disability, the optionee will
have no more than three months after such termination during which the optionee
will be entitled to exercise the option, unless otherwise determined by our
board of directors. Upon termination of employment or engagement of
an optionee by reason of death or permanent and total disability, the optionee’s
options remain exercisable for one year to the extent the options were
exercisable on the date of such termination. No similar limitation
applies to non-qualified options.
We must
grant options under the 2005 plan within ten years from the effective date of
the 2005 plan. The effective date of the 2005 plan was January 1,
2005. Subject to a number of exceptions, holders of incentive stock
options granted under the 2005 plan cannot exercise these options more than ten
years from the date of grant. Options granted under the 2005 plan
generally provide for the payment of the exercise price in cash and may provide
for the payment of the exercise price by delivery to us of shares of common
stock already owned by the optionee having a fair market value equal to the
exercise price of the options being exercised, or by a combination of these
methods. Therefore, if it is provided in an optionee’s options, the
optionee may be able to tender shares of common stock to purchase additional
shares of common stock and may theoretically exercise all of his stock options
with no additional investment other than the purchase of his original
shares.
Any
unexercised options that expire or that terminate upon an employee’s ceasing to
be employed by us become available again for issuance under the 2005
plan.
Additional
Option Issuances
There are
options to purchase 11,151,399 shares of common stock granted outside the
plans. As of October 1, 2009, approximately 4,051,399 of these
options have vested.
STOCK
OWNERSHIP
The
following table sets forth certain information with respect to the beneficial
ownership of our common stock as of October 1, 2009 of:
|
·
|
each
person who is known by us to be the beneficial owner of more than 5% of
our outstanding common stock;
|
|
·
|
each
of our named executive officers;
and
|
|
·
|
all
of our directors and executive officers as a
group.
|
As used
in the table below and elsewhere in this prospectus, the term beneficial
ownership with respect to our common stock consists of sole or shared voting
power (which includes the power to vote, or to direct the voting of shares of
our common stock) or sole or shared investment power (which includes the power
to dispose, or direct the disposition of, shares of our common stock) through
any contract, arrangement, understanding, relationship or otherwise, including a
right to acquire such power(s) during the 60 days following October 1,
2009.
Unless
otherwise indicated in the footnotes to this table, and subject to community
property laws where applicable, we believe each of the stockholders named in
this table has sole voting and investment power with respect to the shares
indicated as beneficially owned. Applicable percentages are based on
115,638,243 shares of common stock outstanding as of October 1, 2009, adjusted
as required by the rules promulgated by the SEC. Unless otherwise
indicated, the address for each of the individuals and entities listed in this
table is the Technology Centre of New Jersey, 675 Route One, North Brunswick,
New Jersey 08902.
Name and Address
of Beneficial Owner
|
|
Number of
Shares of
our Common Stock
Beneficially Owned
|
|
|
Percentage
of Class
Beneficially Owned
|
|
|
|
|
|
|
|
|
Thomas
A. Moore
|
|
|
6,867,368 |
(1) |
|
|
5.8 |
% |
Roni
A. Appel
|
|
|
6,751,419 |
(2) |
|
|
5.6 |
% |
Richard
Berman
|
|
|
2,103,954 |
(3) |
|
|
1.8 |
% |
Dr.
James Patton
|
|
|
3,355,394 |
(4) |
|
|
2.9 |
% |
Dr.
Thomas McKearn
|
|
|
832,372 |
(5) |
|
|
* |
|
Dr.
John Rothman
|
|
|
2,036,281 |
(6) |
|
|
1.7 |
% |
Fredrick
Cobb
|
|
|
1,085,812 |
(7) |
|
|
* |
|
All
Directors and Executive Officers as a Group (7 people)
|
|
|
23,032,600 |
(8) |
|
|
18.1 |
% |
* Less than 1%.
(1)
|
Represents
3,425,700 shares of our common stock and options to purchase
3,441,668 shares of our common stock exercisable within 60
days. In addition, Mr. Moore owns warrants to purchase
4,511,790 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).
|
(2)
|
Represents
4,130,134 shares of our common stock, options to purchase 2,524,923 shares
of our common stock exercisable within 60 days, warrants to purchase
72,362 shares of our common stock exercisable within 60 days and 24,000
shares of our common stock earned but not yet issued. In
addition, Mr. Appel owns warrants to purchase 648,094 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. Appel provides
us with 61 days' notice of the holders waiver of such provisions).
|
(3)
|
Represents
760,624 shares of our common stock, options to purchase 608,333 shares of
our common stock exercisable within 60 days and 734,997 shares of our
common stock earned but not yet
issued.
|
(4)
|
Represents
2,820,576 shares of our common stock, options to purchase 219,086 shares
of our common stock exercisable within 60 days, warrants to purchase
267,732 shares of our common stock exercisable within 60 days and 48,000
shares earned but not yet issued.
|
(5)
|
Represents
179,290 shares of our common stock, options to purchase 441,096 shares of
our common stock exercisable within 60 days, warrants to purchase 163,986
shares of our common stock exercisable within 60 days and 48,000 shares of
our common stock earned but not yet
issued.
|
(6)
|
Represents
275,775 shares of our common stock, options to purchase 1,426,667 shares
of our common stock exercisable within 60 days and 333,839 shares of
our common stock earned but not yet
issued.
|
(7)
|
Represents
90,336 shares of our common stock, options to purchase 772,917 shares of
our common stock exercisable within 60 days and 222,559
shares of our common stock earned but not yet
issued.
|
(8)
|
Represents
an aggregate of 11,682,435 shares of our common stock, options to purchase
9,434,690 shares of our common stock exercisable within 60 days, warrants
to purchase 504,080 shares of our common stock exercisable within 60 days
and 1,411,395 shares of our common stock earned but not yet
issued.
|
SELLING
STOCKHOLDERS
The
selling stockholders may offer and sell, from time to time, any or all of the
shares of common stock covered by this prospectus. The following table provides,
as of October 1, 2009, information regarding the beneficial ownership of our
common stock held by each selling stockholder (including holders of warrants for
shares being registered), the shares that may be sold by each selling
stockholder under this prospectus and the number of shares of common stock that
each selling stockholder will beneficially own after this offering.
The
information set forth in the table and related footnotes are prepared based on
our transfer agent’s records as of October 1, 2009 and information provided to
us by or on behalf of the selling stockholders. Applicable percentages are based
on 115,638,243 shares of common stock outstanding as of October 1, 2009,
adjusted as required by the rules promulgated by the SEC. Because the selling
stockholders may dispose of all, none or some portion of the shares, no estimate
can be given as to the number of shares that will be beneficially owned by the
selling stockholders upon termination of this offering. For purposes of the
table below, however, we have assumed that after termination of this offering
none of the shares covered by this prospectus will be beneficially owned by the
selling stockholders and further assumed that the selling stockholders will not
acquire beneficial ownership of any additional shares during the offering. In
addition, the selling stockholders may have sold, transferred or otherwise
disposed of, or may sell, transfer or otherwise dispose of, at any time and from
time to time, the shares of our common stock in transactions exempt from the
registration requirements of the Securities Act of 1933 after the date on which
the information in the table is presented.
We may
amend or supplement this prospectus from time to time in the future to update or
change this list of selling stockholders and shares that may be
resold.
Selling
Stockholder
|
|
Shares Beneficially
Owned Before
Offering (1)
|
|
|
Shares Being
Offered
|
|
|
Shares to be Beneficially
Owned After
Offering
|
|
|
Percentage to be Beneficially
Owned After
Offering
|
|
2056850
Ontario Inc.
|
|
|
1,168,924 |
|
|
|
500,000 |
|
|
|
668,924 |
|
|
*
|
|
Alpha
Capital
|
|
|
1,250,000 |
|
|
|
1,250,000 |
|
|
|
0 |
|
|
—
|
Andrew
Latos
|
|
|
592,909 |
|
|
|
275,000 |
|
|
|
317,909 |
|
|
*
|
|
Anthony
G. Polak
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
0 |
|
|
—
|
|
Ariel
Shatz and Talya Miron-Shatz
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Arthur
& Christine Handal
|
|
|
125,000 |
|
|
|
125,000 |
|
|
|
0 |
|
|
—
|
|
Gerald
A. Brauser TTEE FBO Bernice Brauser
Irrevocable Trust
|
|
|
1,753,383 |
|
|
|
750,000 |
|
|
|
1,003,383 |
|
|
*
|
|
Bridge
Ventures, Inc. (2)
|
|
|
950,678 |
|
|
|
150,000 |
|
|
|
800,678 |
|
|
*
|
|
Brio
Capital LP
|
|
|
1,553,888 |
|
|
|
750,000 |
|
|
|
803,888 |
|
|
*
|
|
CAMOFI
Master LDC (3)(4)
|
|
|
9,986,666 |
|
|
|
8,000,000 |
|
|
|
1,986,666 |
|
|
1.7%
|
|
CAMHZN
Master LDC (4)(5)
|
|
|
2,496,667 |
|
|
|
2,000,000 |
|
|
|
496,667 |
|
|
*
|
|
Carter
Management Group LLC (6)
|
|
|
606,194 |
|
|
|
375,000 |
|
|
|
231,194 |
|
|
*
|
|
Cary
Fields
|
|
|
2,630,081 |
|
|
|
1,125,000 |
|
|
|
1,505,081 |
|
|
1.3%
|
|
Castlerigg
Master Investments, Ltd.
|
|
|
4,975,000 |
|
|
|
4,975,000 |
|
|
|
0 |
|
|
—
|
|
Chestnut
Ridge Partners LP
|
|
|
3,000,000 |
|
|
|
3,000,000 |
|
|
|
0 |
|
|
—
|
|
Christopher
Kyriakides
|
|
|
807,500 |
|
|
|
757,500 |
|
|
|
50,000 |
|
|
*
|
|
David
Ismailer
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Dr.
Philip and Maxine Patt
|
|
|
2,045,619 |
|
|
|
875,000 |
|
|
|
1,170,619 |
|
|
1.0%
|
|
Emilio
DiSanluciano
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
0 |
|
|
—
|
|
Endeavor
Asset Mgmt.
|
|
|
953,826 |
|
|
|
500,000 |
|
|
|
453,826 |
|
|
*
|
|
Flavio
Sportelli
|
|
|
263,009 |
|
|
|
112,500 |
|
|
|
150,509 |
|
|
*
|
|
Gerald
Cohen
|
|
|
350,678 |
|
|
|
150,000 |
|
|
|
200,678 |
|
|
*
|
|
Gregory
William Eagan
|
|
|
350,678 |
|
|
|
150,000 |
|
|
|
200,678 |
|
|
*
|
|
IRA
FBO Ronald M. Lazar
|
|
|
75,000 |
|
|
|
75,000 |
|
|
|
0 |
|
|
—
|
|
Isaac
Cohen
|
|
|
116,893 |
|
|
|
50,000 |
|
|
|
66,893 |
|
|
*
|
|
Jack
Erlanger
|
|
|
125,000 |
|
|
|
125,000 |
|
|
|
0 |
|
|
—
|
|
John
Golfinos
|
|
|
1,168,926 |
|
|
|
500,000 |
|
|
|
668,926 |
|
|
*
|
|
John
Lilly (7)
|
|
|
2,651,573 |
|
|
|
750,000 |
|
|
|
1,901,573 |
|
|
1.6%
|
|
Joseph
Giamanco
|
|
|
375,000 |
|
|
|
375,000 |
|
|
|
0 |
|
|
—
|
|
Julie
Arkin
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Keith
M Rosenbloom
|
|
|
292,232 |
|
|
|
125,000 |
|
|
|
167,232 |
|
|
*
|
|
Leonard
Cohen
|
|
|
350,678 |
|
|
|
150,000 |
|
|
|
200,678 |
|
|
*
|
|
Lipman
Capital Group Inc. Retirement Plan (6)
|
|
|
638,555 |
|
|
|
288,750 |
|
|
|
349,805 |
|
|
*
|
|
Mary
Tagliaferri
|
|
|
116,893 |
|
|
|
50,000 |
|
|
|
66,893 |
|
|
*
|
|
Michael
Freedman
|
|
|
125,000 |
|
|
|
125,000 |
|
|
|
0 |
|
|
—
|
|
Michael
Miller
|
|
|
375,000 |
|
|
|
375,000 |
|
|
|
0 |
|
|
—
|
|
Michael
Sobeck
|
|
|
62,500 |
|
|
|
62,500 |
|
|
|
0 |
|
|
—
|
|
Micro
Capital Fund LP
|
|
|
1,130,081 |
|
|
|
1,125,000 |
|
|
|
5,081 |
|
|
*
|
|
Micro
Capital Fund Ltd.
|
|
|
375,000 |
|
|
|
375,000 |
|
|
|
0 |
|
|
—
|
|
Oppenheimer &
Co. Inc. (8)
|
|
|
375,000 |
|
|
|
375,000 |
|
|
|
0 |
|
|
—
|
|
Optimus
CG II, Ltd. (9)
|
|
|
0 |
|
|
|
33,750,000 |
|
|
|
0 |
|
|
—
|
|
Othon
Mourkakos
|
|
|
1,883,388 |
|
|
|
750,000 |
|
|
|
1,133,388 |
|
|
1.0%
|
|
Pan
Brothers
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Peter
Latos, Esq.
|
|
|
400,000 |
|
|
|
400,000 |
|
|
|
0 |
|
|
—
|
|
Peter
Malo
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Philip
DiPippo
|
|
|
444,463 |
|
|
|
250,000 |
|
|
|
194,463 |
|
|
*
|
|
Phylis
Meier
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
Platinum
Long Term Growth VII
|
|
|
5,000,000 |
|
|
|
5,000,000 |
|
|
|
0 |
|
|
—
|
|
Revach
|
|
|
509,463 |
|
|
|
250,000 |
|
|
|
259,463 |
|
|
*
|
|
RL
Capital Partners (10)
|
|
|
125,000 |
|
|
|
125,000 |
|
|
|
0 |
|
|
—
|
|
Robert
& Donna Goode
|
|
|
75,000 |
|
|
|
75,000 |
|
|
|
0 |
|
|
—
|
|
Robert
Allen Papiri
|
|
|
848,442 |
|
|
|
275,000 |
|
|
|
573,442 |
|
|
*
|
|
Robert
H. Cohen (11)
|
|
|
6,046,324 |
|
|
|
2,500,000 |
|
|
|
3,546,324 |
|
|
3.1%
|
|
Spallino
Family Trust
|
|
|
292,232 |
|
|
|
125,000 |
|
|
|
167,232 |
|
|
*
|
|
Steven
B. Gold IRA, Charles Schwab & Co., Inc.,
Custodian (12)
|
|
|
752,191 |
|
|
|
250,000 |
|
|
|
502,191 |
|
|
*
|
|
Steven
J. Shankman
|
|
|
301,355 |
|
|
|
300,000 |
|
|
|
1,355 |
|
|
*
|
|
Suzanne
Henry
|
|
|
584,463 |
|
|
|
250,000 |
|
|
|
334,463 |
|
|
*
|
|
MLPF
CUST FBO Thomas A. Moore IRRA(13)
|
|
|
11,379,157 |
|
|
|
2,000,000 |
|
|
|
9,379,157 |
|
|
7.5%
|
|
Whalehaven
Capital Fund Limited
|
|
|
1,250,000 |
|
|
|
1,250,000 |
|
|
|
0 |
|
|
—
|
|
Zenith
Capital Corporation Money Purchase Pension Plan
|
|
|
375,000 |
|
|
|
375,000 |
|
|
|
0 |
|
|
—
|
|
(Please see footnotes on the following
page.)
* Less
than 1%.
(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)
|
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 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.
|
(3)
|
CAMOFI
holds warrants to purchase 9,986,666 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.
|
(4)
|
Pursuant
to a consulting agreement between us and Centrecourt dated August 1, 2007,
we paid Centrecourt $328,000 in cash and issued to it 2,483,333 $0.20
warrants for strategic advisory services provided to us. Centrecourt
transferred the $0.20 warrants to CAMOFI and CAMHZN. Centrecourt disclaims
beneficial ownership of all of our
securities.
|
(5)
|
CAMHZN
holds warrants to purchase 2,496,667 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.
|
(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. 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.
|
(8)
|
Oppenheimer
& Co. Inc. advised us that it is a registered broker-dealer.
Oppenheimer & Co. Inc. further 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.
|
(9)
|
The
sole stockholder of Optimus CG II, Ltd. is Optimus Capital Partners, LLC,
d/b/a Optimus Life Sciences Capital Partners, LLC. Voting and dispositive
power with respect to the shares held by Optimus CG II, Ltd. is exercised
by Terry Peizer, the Managing Director of Optimus Life Sciences Capital
Partners, LLC, who acts as investment advisor to Optimus CG II, Ltd.
Optimus CG II, Ltd. is not a registered broker-dealer or an affiliate of a
registered broker-dealer. On September 24, 2009, we issued to Optimus
CG II, Ltd., pursuant to the Optimus purchase agreement, a three-year
warrant to purchase up to 33,750,000 shares of our common stock, at an
initial exercise price of $0.20 per share, subject to adjustment as
provided in the warrant. The warrant will become exercisable upon the
effectiveness of the registration statement of which this prospectus forms
a part.
|
(10)
|
Ronald
Lazar and Anthony Polak are the Managing Members of RL Capital Management,
LLC, the General Partner of RL Capital
Partners.
|
(11)
|
Includes
warrants to purchase 2,500,000 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).
|
(12)
|
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.
|
(13)
|
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 3,441,668 shares of our common stock exercisable within 60 days,
and warrants to purchase 4,511,790 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).
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Our
policy is to enter into transactions with related parties on terms that, on the
whole, are no more favorable, or no less favorable, than those available from
unaffiliated third parties. Based on our experience in the business
sectors in which we operate and the terms of our transactions with unaffiliated
third parties, we believe that all of the transactions described below met this
policy standard at the time they occurred.
We
entered into a consulting agreement with LVEP dated as of January 19, 2005, and
amended on April 15, 2005, and October 31, 2005, pursuant to which Mr. Appel
served as our Chief Executive Officer, Chief Financial Officer and Secretary and
was compensated by consulting fees paid to LVEP. LVEP is owned by the
estate of Scott Flamm (deceased January 2006) previously, one of our
directors. Pursuant to an amendment dated December 15,
2006. Mr. Appel resigned as our President and Chief Executive Officer
and Secretary as of December 15, 2006, but remains as a member of our board of
directors and remained as a consultant to us until December 15,
2007. The consulting agreement terminated on December 15,
2008. Mr. Appel devoted 50% of his time over the first twelve months
of the consulting period to support us. Also as a consultant, he was
paid at a rate of $22,500 per month in addition to benefits as provided to other
company officers. He received severance payments over an additional
twelve months at a rate of $10,416.67 per month and was reimbursed for family
health care. All his stock options became fully vested on December
15, 2006. Also, Mr. Appel was issued 1,000,000 shares of our common
stock on January 2, 2007. He received a $250,000 bonus with $100,000
paid on January 3, 2007 and the remainder was paid in October
2007. We and LVEP agreed to a one time payment of $130,000 and
$14,615.37 in our common stock (153,846 shares) in settlement of the final two
months compensation and the twelve months severance.
On August
24, 2007, we issued and sold an aggregate of $600,000 principal amount
promissory notes bearing interest at a rate of 12% per annum and warrants to
purchase an aggregate of 150,000 shares of our common stock to three investors
including Mr. Moore, our Chief Executive Officer. Mr. Moore invested
$400,000 and received warrants for the purchase of 100,000 shares of our common
stock. The promissory note and accrued but unpaid interest thereon
were convertible at the option of the holder into shares of our common stock
upon the closing by us of a sale of its equity securities aggregating $3.0
million or more in gross proceeds to us at a conversion rate which will be the
greater of a price at which such equity securities were sold or the price per
share of the last reported trade of our common stock on the market on which our
common stock is then listed, as quoted by Bloomberg LP. At any time
prior to conversion, we had the right to prepay the promissory notes and accrued
but unpaid interest thereon. Mr. Moore converted his $400,000 bridge
investment into 2,665,667 shares of common stock and 2,000,000 $0.20 warrants
based on the terms of the private placement. He was paid $7,101.37
interest in cash.
On
September 22, 2008, we entered into a note purchase agreement with our Chief
Executive Officer, Thomas A. Moore, pursuant to which we agreed to sell to Mr.
Moore, from time to time, one or more senior promissory notes, which we refer to
as the Moore Notes. On June 15, 2009, we amended the terms of the
Moore Notes to increase the amounts available from $800,000 to $950,000 and to
change the maturity date of the Moore Notes from June 15, 2009 to the earlier of
January 1, 2010 or our next equity financing resulting in gross proceeds to us
of at least $6.0 million.
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 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 June 2009 bridge financing increasing the number of shares underlying the
warrant from one share per $1.00 invested to two and one-half shares. The final
terms are anticipated to contain the same terms and conditions as warrants
issued to investors in the subsequent financing. As of July 31, 2009,
$947,985 in notes were outstanding and payable to Mr. Moore.
DESCRIPTION
OF OUR CAPITAL STOCK
General
At the
date hereof, we are authorized by our articles of incorporation to issue an
aggregate of 500,000,000 shares of common stock, par value $0.001 per share, and
5,000,000 shares of “blank check” preferred stock, par value $0.001 per
share. As of October 1, 2009, there were 115,638,243 shares of common
stock and no shares of preferred stock outstanding.
Common
Stock
Holders
of our common stock are entitled to one vote for each share held of record on
each matter submitted to a vote of stockholders. There is no
cumulative voting for the election of directors. Subject to the prior
rights of any class or series of preferred stock which may from time to time be
outstanding, if any, holders of our common stock are entitled to receive
ratably, dividends when, as, and if declared by our board of directors out of
funds legally available for that purpose and, upon our liquidation, dissolution,
or winding up, are entitled to share ratably in all assets remaining after
payment of liabilities and payment of accrued dividends and liquidation
preferences on the preferred stock, if any. Holders of our common
stock have no preemptive rights and have no rights to convert their common stock
into any other securities. The outstanding common stock is validly
authorized and issued, fully-paid and nonassessable.
The
shares of common stock offered in this prospectus have been fully paid and are
not liable for further call or assessment. Holders of our common
stock do not have cumulative voting rights, which means that the holders of more
than one half of the outstanding shares of common stock, subject to the rights
of the holders of the preferred stock, if any, can elect all of our directors,
if they choose to do so. In this event, the holders of the remaining
shares of common stock would not be able to elect any
directors. Except as otherwise required by Delaware law, and subject
to the rights of the holders of preferred stock, if any, all stockholder action
is taken by the vote of a majority of the outstanding shares of common stock
voting as a single class present at a meeting of stockholders at which a quorum
consisting of a majority of the outstanding shares of common stock is present in
person or proxy.
Preferred
Stock
We are
authorized to issue up to 5,000,000 shares of “blank check” preferred
stock. Preferred stock may be issued in one or more series and having
the rights, privileges and limitations, including voting rights, conversion
privileges and redemption rights, as may, from time to time, be determined by
our board of directors. Preferred stock may be issued in the future
in connection with acquisitions, financings, or other matters as our board of
directors deems appropriate. In the event that any shares of
preferred stock are to be issued, a certificate of designation containing the
rights, privileges and limitations of such series of preferred stock will be
filed with the Secretary of State of the State of Delaware. The
effect of such preferred stock is that, subject to Federal securities laws and
Delaware law, our board of directors alone, may be able to authorize the
issuance of preferred stock which could have the effect of delaying, deferring,
or preventing a change in control of us without further action by the
stockholders, and may adversely affect the voting and other rights of the
holders of our common stock. The issuance of preferred stock with
voting and conversion rights may also adversely affect the voting power of
holders of our common stock, including the loss of voting control to
others.
Pursuant
to the Optimus purchase agreement, Optimus has agreed to purchase, upon the
terms and subject to the conditions set forth therein and described below, up to
$5.0 million of our newly authorized, non-convertible, redeemable Series A
preferred stock at a price of $10,000 per share. Under
the terms of the purchase agreement, from time to time until September 24, 2012,
in our sole discretion, we may present Optimus with a notice to purchase a
specified amount of Series A preferred stock, which Optimus is obligated to
purchase on the 10th trading day after the date of the notice, subject to
satisfaction of certain closing conditions. We will determine, in our
sole discretion, the timing and amount of Series A preferred stock to be
purchased by Optimus, and may sell such shares in multiple
tranches. Optimus will not be obligated to purchase the Series A
preferred stock upon our notice (i) in the event the closing price of our common
stock during the nine trading days following delivery of our notice falls below
75% of the closing price on the trading day prior to the date such notice is
delivered to Optimus or (ii) to the extent such purchase would result in Optimus
and its affiliates beneficially owning more than 9.99% of our outstanding common
stock.
The
Series A preferred stock is redeemable at our option on or after the fifth
anniversary of the date of its issuance. The Series A preferred stock also has a
liquidation preference per share equal to the original price per share thereof
plus all accrued dividends thereon, and is subject to repurchase by us at
Optimus’s election under certain circumstances, or following the consummation of
certain fundamental transactions by us, at the option of a majority of the
holders of the outstanding shares of our Series A preferred stock.
Holders
of Series A preferred stock will be entitled to receive dividends, which will
accrue in shares of Series A preferred stock on an annual basis at a rate equal
to 10% per annum from the issuance date. Accrued dividends will be payable upon
redemption of the Series A preferred stock. The Series A preferred stock ranks,
with respect to dividend rights and rights upon liquidation:
|
·
|
senior
to our common stock and any other class or series of preferred stock
(other than 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.
|
The
Optimus purchase agreement further provides that we will pay to Optimus a
non-refundable fee of up to $250,000, $125,000 of which was paid in cash on
October 28, 2009, and $125,000 of which shall be paid on the closing
date of the first tranche (by offset from the gross proceeds of such
tranche).
Our right
to deliver a notice to Optimus requiring Optimus to make a purchase, and the
obligation of Optimus to accept a notice and to acquire and pay for the Series A
preferred stock subject to such notice at a tranche closing, are subject to the
satisfaction (or waiver) of certain conditions, which include, among
others:
|
·
|
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.
|
Stock
Symbol
Our
common stock is quoted on the OTC Bulletin Board under the symbol
ADXS.OB. On November 3, 2009, the last reported sale price per share
for our common stock as reported by the OTC Bulletin Board was
$0.12.
Warrants
At the
time of execution of the Optimus purchase agreement, we issued to an affiliate
of Optimus a three-year warrant to purchase up to 33,750,000 shares of our
common stock, at an initial exercise price of $0.20 per share, subject to
adjustment as provided in the warrant. The warrant will become exercisable on
the earlier of (i) the date on which a registration statement registering for
resale the shares of our common stock issuable upon exercise of the warrant
becomes effective and (ii) the first date on which such shares underlying the
warrant are eligible for resale without limitation under Rule 144 (assuming a
cashless exercise of the warrant). The exercise price of the warrant may be paid
(at the option of Optimus) in cash or by Optimus’s issuance of a four-year,
full-recourse promissory note, bearing interest at 2% per annum, and secured by
specified portfolio of assets owned by Optimus. The warrant also provides for
cashless exercise if at any time a registration statement is not effective (or
the prospectus contained therein is not available for use) for the resale of the
shares underlying the warrant. If
Optimus fails to acquire and pay for the Series A preferred stock upon delivery
of our notice in accordance with the terms of the Optimus purchase agreement
(assuming the timely and full satisfaction of all of the conditions set forth
therein) and the warrant has not previously been exercised in full, we
have the right to demand surrender of the warrant (or any remaining portion
thereof) without compensation, and the warrant shall automatically be
cancelled.
As part
of the October 17, 2007 private placement, investors were issued units
consisting of one share of common stock and ¾ of a five-year warrant to purchase
one share of common stock at an exercise price of $0.20 per share. The $0.20
warrants provide for adjustment of their exercise prices upon the occurrence of
certain events, such as payment of a stock dividend, a stock split, a reverse
split, a reclassification of shares, or any subsequent equity sale, rights
offering, pro rata distribution (full ratchet), or any fundamental transaction
such as a merger, sale of all of its assets, tender offer or exchange offer, or
reclassification of its common stock. If at any time after October
17, 2008 there is no effective registration statement registering, or no current
prospectus available for, the resale of the shares underlying the warrants by
the holder of such warrants, then the warrants may also be exercised at such
time by means of a “cashless exercise.” The $0.20 warrants provide that they may
not be exercised if, following the exercise, the holder will be deemed to be the
beneficial owner of more than 9.99% of our outstanding shares of common
stock.
In
connection with the June 2009 bridge financing and October 2009 bridge
financing, we issued five-year warrants to purchase an aggregate
of 6,841,625 shares of our common stock at an exercise price of $0.20 per
share. The June 2009 bridge warrants and October 2009 bridge warrants
provide for adjustment of their exercise prices upon the occurrence of certain
events, such as payment of a stock dividend, a stock split, a reverse split, a
reclassification of shares, or any subsequent equity sale, rights offering, pro
rata distribution (full ratchet), or any fundamental transaction such as a
merger, sale of all of its assets, tender offer or exchange offer, or
reclassification of its common stock. Each of the June 2009 bridge warrants and
October 2009 bridge warrants may be exercised on a cashless basis under certain
circumstances. Each of the June 2009 bridge warrants and October 2009
bridge warrants provide that they may not be exercised if, following the
exercise, the holder will be deemed to be the beneficial owner of more than
9.99% of our outstanding shares of common stock.
Registration
Rights
In
connection with our October 2007 private placement, we entered into a
registration rights agreement with the investors in that offering pursuant to
which we agreed to file a registration statement with the SEC within 45 days
after the final closing of the offering covering all of the shares of common
stock sold to the investors in the October 2007 private placement and all of the
shares of common stock underlying the warrants that were sold to the investors
in that offering. Accordingly,
we initially filed a registration statement on Form SB-2 with the SEC on
November 30, 2007 to register all of such shares of common stock. The
Form SB-2 registration statement was declared effective by the SEC on January
22, 2008. Under the terms of the registration rights agreement, we agreed to
keep the registration statement effective until the earlier of (i) the date on
which all of those shares of common stock may be resold without registration
under the Securities Act without regard to any volume limitations under Rule 144
under the Securities Act or (ii) the date on which all of those shares of common
stock have been resold pursuant to the registration statement or Rule 144 under
the Securities Act.
The
registration rights agreement provides that if, among other things, the
registration statement ceases for any reason to remain continuously effective,
or the selling stockholders are otherwise not permitted to use it to resell
their shares of common stock for more than 10 consecutive calendar days or more
than a total of twenty calendar days (which need not be consecutive calendar
days) during any 12-month period, then we are required to pay as partial
liquidated damages an amount equal to 1.5% of the aggregate purchase price paid
by the selling stockholder for such common stock, up to a maximum of 15% of such
purchase price. If we fail to pay any required partial liquidated
damages in full within seven days after the date payable, we are then required
to pay interest thereon at a rate of 15% per annum (or such lesser maximum
amount that is permitted to be paid by applicable law) to the selling
stockholder, accruing daily from the date such partial liquidated damages are
due until such amounts, plus all such interest thereon, are paid in
full.
We filed
a post-effective amendment on Form S-1 to our original registration statement on
Form SB-2 to, among other things, update the information included in the
original registration statement, convert the original registration statement to
a registration statement on Form S-1, and to deregister shares of our common
stock which were covered by the original registration statement, but are no
longer required to be registered under the terms of our registration rights
agreement with the selling stockholders named in this
prospectus. This prospectus forms a part of the registration
statement, as amended by the post-effective amendment.
Pursuant
to the terms of the Optimus purchase agreement, our right to deliver a notice to
Optimus requiring Optimus to acquire and pay for the Series A preferred stock
are subject to the Company having a current, valid and effective registration
statement covering the resale of all shares underlying the warrant unless all
shares underlying the warrant are eligible for resale without limitation under
Rule 144 (assuming cashless exercise of the warrant).
Certain
of the selling stockholders named in this prospectus have waived, among other
things, any right to receive any liquidated damages which may have accrued
pursuant to the registration rights agreement before the date of this
prospectus.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Securities Transfer
Corporation, 2591 Dallas Parkway, Suite 102, Frisco, TX 75034.
SHARES
ELIGIBLE FOR FUTURE SALE
As of
October 1, 2009, we had 115,638,243 shares of common stock outstanding, not
including shares issuable upon conversion of our Series A preferred stock or
shares issuable upon exercise of our warrants. All shares sold in
this offering will be freely tradable without restriction or further
registration under the Securities Act, unless they are purchased by our
“affiliates,” as that term is defined in Rule 144 promulgated under the
Securities Act.
The
outstanding shares of our common stock not included in this prospectus will be
available for sale in the public market as follows:
Public
Float
Of our
outstanding shares, 11,685,435 shares are beneficially owned by executive
officers, directors and affiliates (excluding shares of our common stock which
may be acquired upon exercise of stock options and warrants which are currently
exercisable or which become exercisable within 60 days of October 1,
2009). The remaining 103,955,808 shares constitute our public
float.
Rule
144
In
general, under Rule 144, as currently in effect, a person who has beneficially
owned shares of our common stock for at least six months, including the holding
period of prior owners other than affiliates, is entitled to sell his or her
shares without any volume limitations; an affiliate, however, can sell such
number of shares within any three-month period as does not exceed the greater
of:
|
·
|
1%
of the number of shares of our common stock then outstanding, which
equaled 1,156,382 shares as of October 1, 2009,
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.
|
Sales
under Rule 144 are also subject to manner-of-sale provisions, notice
requirements and the availability of current public information about
us. In order to effect a Rule 144 sale of our common stock, our
transfer agent will require an opinion from legal counsel. We may
charge a fee to persons requesting sales under Rule 144 to obtain the necessary
legal opinions.
As of
October 1, 2009, approximately 103,955,808 shares of our common stock were
available for sale by non-affiliates of ours under Rule 144.
Rule
701
Rule 701
permits our employees, officers or directors who purchased shares of our common
stock pursuant to a written compensatory plan or contract to resell such shares
in reliance upon Rule 144 but without compliance with specific
restrictions. Rule 701 provides that affiliates may sell their Rule
701 shares of common stock under Rule 144 without complying with the holding
period requirement and that non-affiliates may sell such shares in reliance on
Rule 144 without complying with the holding period, public information, volume
limitation or notice provisions of Rule 144.
Stock
Options
We have
registered by means of a registration statement on Form S-8 under the Securities
Act of the 1933 2,381,525 shares of common stock reserved for issuance under our
2004 Stock Option Plan. As of October 1, 2009, options to purchase
2,381,525 shares of common stock were granted under the 2004 Stock Option Plan,
of which options to purchase approximately 2,325,275 shares of common stock have
vested and have not been exercised. Shares of common stock issued
upon exercise of a share option and registered under registration statement on
Form S-8 will, subject to vesting provisions and Rule 144 volume limitations
applicable to our affiliates and the lock-up provision described below, be
available for sale in the open market immediately.
Our 2005
stock option plan was approved by the stockholders on June 6, 2006, for
5,600,000 shares of common stock reserved for issuance. As of October
1, 2009, options to purchase 5,429,917 shares of common stock were granted under
the 2005 Stock Option Plan of which options to purchase approximately 5,015,334
shares of common stock have vested and have not been
exercised. Shares of common stock issued upon exercise of a share
option may be eligible for sale, subject to vesting provisions, volume
limitations and other limitations of Rule 144.
There are
options to purchase 11,151,399 shares of common stock granted outside the
plans. As of October 1, 2009, approximately 4,051,399 of these
options have vested.
Lock
Up of Shares
We
entered into the Optimus stock purchase agreement pursuant to which Optimus
committed to purchase up to $5.0 million of the Series A preferred
stock. In order to induce Optimus to enter into the preferred stock
purchase agreement, our executive officers, directors and beneficial owners of
10% or more of our common stock agreed that, for a period of ten trading days
beginning on each date we deliver a notice exercising the put described in the
preferred stock purchase agreement to Optimus and ending on the closing date of
the put exercise, they will not, without the prior written consent of Optimus,
(a) sell, offer to sell, contract or agree to sell, hypothecate, pledge, grant
any option to purchase or otherwise dispose of or agree to dispose of, directly
or indirectly, in respect of, or establish or increase a put equivalent position
or liquidate or decrease a call equivalent position with respect to, any of our
common stock or any securities convertible into or exercisable or exchangeable
for our common Stock, or warrants or other rights to purchase our common stock
or any such securities, or any securities substantially similar to our common
stock, (b) enter into any swap or other arrangement that transfers to another,
in whole or in part, any of the economic consequences of ownership of our common
stock or any securities convertible into or exercisable or exchangeable for our
common stock or any such securities, or warrants or other rights to purchase our
common stock, whether any such transaction is to be settled by delivery of our
common stock or such other securities, in cash or otherwise or (c) publicly
announce an intention to effect any transaction specified in clause (a) or
(b).
PLAN OF
DISTRIBUTION
Each
selling stockholder of our common stock and any of their donees, pledgees,
transferees, assignees and other successors-in-interest may, from time to time,
sell, transfer or otherwise dispose of any or all of their shares of common
stock on the OTC Bulletin Board or any other stock exchange, market or trading
facility on which the shares are traded or in private
transactions. These sales may be at fixed or negotiated prices. A
selling stockholder may use any one or more of the following methods when
selling shares:
|
·
|
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.
|
The
selling stockholders may also sell shares under Rule 144 under the Securities
Act, if available, rather than under this prospectus.
Broker-dealers
engaged by any selling stockholder may arrange for other broker-dealers to
participate in sales. Broker-dealers may receive commissions or
discounts from the selling stockholders (or, if any broker-dealer acts as agent
for the purchaser of shares, from the purchaser) in amounts to be negotiated,
but, except as set forth in a supplement to this prospectus, in the case of an
agency transaction not in excess of a customary brokerage commission in
compliance with FINRA NASD Rule 2440; and in the case of a principal transaction
a markup or markdown in compliance with FINRA IM-2440.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of our common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions and to return borrowed shares in
connection with such short sales, or loan or pledge our common stock to
broker-dealers that in turn may sell these securities. The selling stockholders
may also enter into option or other transactions with broker-dealers or other
financial institutions or the creation of one or more derivative securities
which require the delivery to such broker-dealer or other financial institution
of shares offered by this prospectus, which shares such broker-dealer or other
financial institution may resell pursuant to this prospectus (as supplemented or
amended to reflect such transaction).
The
selling stockholders and any underwriters, broker-dealers or agents that
participate in the sale of our common stock or interests therein may be
considered “underwriters” within the meaning of Section 2(11) of the Securities
Act. In such event, any discounts, commissions, concessions or profit
they earn on any resale of the shares may be deemed to be underwriting discounts
and commissions under the Securities Act. Selling stockholders who
are “underwriters” within the meaning of Section 2(11) of the Securities Act
will be subject to the prospectus delivery requirements of the Securities
Act. Certain of the selling stockholders have advised us that it or
its affiliates are a registered broker-dealer. Each selling stockholder has
informed us that (i) it acquired our common stock and warrants in the ordinary
course of business and (ii) at the time of the purchase of our common stock and
warrants, it did not have any agreement or understanding, directly or
indirectly, to distribute the shares of common stock and warrants offered
hereunder. In no event shall any broker-dealer receive fees,
commissions and markups which, in the aggregate, would exceed eight percent
(8%).
We are
required to pay certain fees and expenses incurred by us incident to the
registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
The
selling stockholders may be subject to the prospectus delivery requirements of
the Securities Act including Rule 172 thereunder. In addition, any
securities covered by this prospectus which qualify for sale pursuant to Rule
144 under the Securities Act may be sold under Rule 144 rather than this
prospectus There is no underwriter or coordinating broker-dealer
acting in connection with the proposed sale of the resale shares by the selling
stockholders.
Under the
terms of the registration rights agreement entered into in connection with the
October 2007 private placement, we agreed to keep the registration statement
effective until the earlier of (i) the date on which all of those shares of
common stock may be resold without registration under the Securities Act without
regard to any volume limitations under Rule 144 under the Securities Act or (ii)
the date on which all of those shares of common stock have been resold pursuant
to the registration statement or Rule 144 under the Securities Act.
The
resale shares will be sold only through registered or licensed broker-dealers if
required under applicable state securities laws. In addition, in certain states,
the resale shares may not be sold unless they have been registered or qualified
for sale in the applicable state or an exemption from the registration or
qualification requirement is available and is complied with. As of
the date of this prospectus, we have not filed for registration or qualification
in any state.
Under
applicable rules and regulations under the Exchange Act, any person engaged in
the distribution of the resale shares may not simultaneously engage in market
making activities with respect to our common stock for the applicable restricted
period, as defined in Regulation M, prior to the commencement of the
distribution. In addition, the selling stockholders will be subject to
applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases and
sales of shares of our common stock by the selling stockholders or any other
person. We will make copies of this prospectus available to the selling
stockholders and have informed them of the need to deliver a copy of this
prospectus to each purchaser at or prior to the time of the sale (including by
compliance with Rule 172 under the Securities Act).
LEGAL
MATTERS
The
validity of the shares of common stock offered by the selling stockholders will
be passed upon for us by our counsel, Greenberg Traurig, LLP, New York, New
York. A shareholder of Greenberg Traurig, LLP owns 3,546,324 shares of our
common stock and warrants to purchase 2,500,000 shares of our common
stock.
EXPERTS
The
financial statements of Advaxis, Inc. as of October 31, 2008 and 2007, and for
the years then ended, and for the two years ended October 31, 2008 in the
cumulative period, from March 1, 2002 (inception) to October 31, 2008, appearing
in this prospectus have been audited by McGladrey & Pullen, LLP, independent
accountants (whose opinion includes a going concern explanatory paragraph), to
the extent and for the periods indicated in their report appearing elsewhere
herein, and are included in reliance upon such report and upon the authority of
such firms as experts in accounting and auditing.
The
financial statements of Advaxis, Inc. included in the cumulative column for the
period March 1, 2002 (inception) to October 31, 2006 appearing in this
prospectus have been audited by Goldstein Golub Kessler LLP, independent
accountants, to the extent and for the periods indicated in their report
appearing elsewhere herein, and are included in reliance upon such report and
upon the authority of such firms as experts in accounting and
auditing.
On
October 31, 2007, we were notified that certain of the partners of Goldstein
Golub Kessler LLP became partners of McGladrey & Pullen, LLP in a limited
asset purchase agreement and that Goldstein Golub Kessler LLP resigned as our
independent registered public accounting firm. At that time, McGladrey &
Pullen, LLP was appointed as our new independent registered public accounting
firm.
INTERESTS
OF NAMED EXPERTS AND COUNSEL
Except as
set forth above under the caption “Legal Matters,” no expert or counsel named in
this prospectus as having prepared or certified any part of this prospectus or
having given an opinion upon the validity of the securities being registered or
upon other legal matters in connection with the registration or offering of our
common stock was employed on a contingency basis or had, or is to receive, in
connection with the offering, a substantial interest, directly or indirectly, in
the registrant or any of its parents or subsidiaries. Nor was any such
person connected with the registrant or any of its parents, subsidiaries as a
promoter, managing or principal underwriter, voting trustee, director, officer
or employee.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
This
prospectus is part of a registration statement we have filed with the SEC.
We have not included in this prospectus all of the information contained in the
registration statement, and you should refer to the registration statement and
its exhibits for further information.
We file
annual, quarterly, and current reports, proxy statements, and other information
with the SEC. You may read and copy any materials we file at the SEC’s
Public Reference Room at 100 F Street, NE., Washington, DC 20549, on official
business days during the hours of 10 a.m. to 3 p.m. You may obtain
information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. The SEC maintains an Internet site that contains reports,
proxy and information statements, and other information regarding issuers that
file electronically with the SEC at http://www.sec.gov.
Our Web
site address is www.advaxis.com. The information on our web site is not
incorporated into this prospectus.
ADVAXIS,
INC.
INDEX
TO FINANCIAL STATEMENTS
|
Page
|
|
|
Audited
Financial Statements
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
|
Report
of Independent Registered Public Accounting Firm |
F-3
|
|
|
Balance
Sheets as of October 31, 2008 and 2007
|
F-4
|
|
|
Statements
of Operations for the years ended October 31, 2008 and 2007 and the period
from March 1, 2002 (Inception) to October 31, 2008
|
F-5
|
|
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to October 31, 2008
|
F-6
|
|
|
Statements
of Cash Flows for the years ended October 31, 2008 and 2007 and the period
from March 1, 2002 (Inception) to October 31, 2008
|
F-8
|
|
|
Notes
to Financial Statements
|
F-10
|
|
|
Unaudited
Interim Financial Statements
|
|
|
|
Balance
Sheets as of July 31, 2009 (unaudited) and October 31,
2008
|
F-29
|
|
|
Statements
of Operations for the three and nine month periods ended July 31, 2009 and
2008 and the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
F-30
|
|
|
Statements
of Cash Flow for the nine month periods ended July 31, 2009 and 2008 and
the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
F-31
|
|
|
Notes
to Unaudited Financial Statements
|
F-33
|
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Shareholders of
Advaxis,
Inc.
We have
audited the balance sheets of Advaxis, Inc. (a development stage company) as of
October 31, 2008 and 2007, and the related statements of operations,
shareholders’ equity (deficiency) and cash flows for the years then ended and
for each of the two years ended included in the cumulative period from March 1,
2002 (inception) to October 31, 2008. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audits. The financial
statements for the period from March 1, 2002 (inception) to October 31, 2006
were audited by other auditors and our opinion, insofar as it relates to
cumulative amounts included for such prior periods, is based solely on the
reports of such other auditors.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, based on our audits and the reports of other auditors, the financial
statements referred to above present fairly, in all material respects, the
financial position of Advaxis, Inc. as of October 31, 2008 and 2007 and the
results of its operations and its cash flows for years then ended and for the
amounts included in the cumulative period from March 1, 2002 (inception) to
October 31, 2008 in conformity with accounting principles generally accepted in
the U.S.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company’s products are being developed and have not generated
significant revenues. As a result, the Company has suffered recurring losses and
its liabilities exceed its assets. This raises substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
/s/
MCGLADREY & PULLEN, LLP
New York,
NY
January
29, 2009
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Shareholders of
Advaxis,
Inc.
We have
audited the accompanying statements of operations, shareholders' equity
(deficiency), and cash flows of Advaxis, Inc. (a development stage company) for
the period included in the cumulative columns from March 1, 2002 (inception) to
October 31, 2006. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the results of operations and cash flows of Advaxis, Inc. for
the period from March 1, 2002 (inception) to October 31, 2006 in conformity with
United States generally accepted accounting principles.
/S/
GOLDSTEIN GOLUB KESSLER LLP
New York,
New York
December
11, 2006
ADVAXIS,
INC.
(A
Development Stage Company)
Balance
Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
|
|
$ |
59,738 |
|
|
$ |
4,041,984 |
|
Prepaid
expenses
|
|
|
38,862 |
|
|
|
199,917 |
|
Total
Current Assets
|
|
|
98,600 |
|
|
|
4,241,901 |
|
|
|
|
|
|
|
|
|
|
Property
and Equipment (net of accumulated depreciation of $92,090 at October 31,
2008 and $55,953 at October 31, 2007)
|
|
|
91,147 |
|
|
|
116,442 |
|
Intangible
Assets (net of accumulated amortization of $205,428 at October 31,
2008 and $149,132 at October 31, 2007)
|
|
|
1,137,397 |
|
|
|
1,098,135 |
|
Other
Assets
|
|
|
3,876 |
|
|
|
3,876 |
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$ |
1,331,020 |
|
|
$ |
5,460,354 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
998,856 |
|
|
$ |
787,297 |
|
Accrued
expenses
|
|
|
603,345 |
|
|
|
305,023 |
|
Notes
payable – current portion including interest payable
|
|
|
563,317 |
|
|
|
80,409 |
|
Total
Current Liabilities
|
|
|
2,165,518 |
|
|
|
1,172,729 |
|
|
|
|
|
|
|
|
|
|
Notes
payable - net of current portion
|
|
|
4,813 |
|
|
|
19,646 |
|
Total
Liabilities
|
|
$ |
2,170,331 |
|
|
$ |
1,192,375 |
|
|
|
|
|
|
|
|
|
|
Shareholders’
Equity (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 109,319,520 at October 31, 2008; and 107,957,777 at October
31, 2007
|
|
|
109,319 |
|
|
|
107,957 |
|
Additional
Paid-In Capital
|
|
|
16,584,414 |
|
|
|
16,276,648 |
|
Deficit
accumulated during the development stage
|
|
|
(17,533,044 |
) |
|
|
(12,116,626 |
) |
Total
Shareholders’ (Deficiency) Equity
|
|
|
(839,311 |
) |
|
|
4,267,979 |
|
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
|
$ |
1,331,020 |
|
|
$ |
5,460,354 |
|
The
accompanying notes and the report of independent registered public accounting
firm
should be read in conjunction with
the financial statements.
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Operations
|
|
Year Ended
October 31, 2008
|
|
|
Year Ended
October 31, 2007
|
|
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$ |
65,736 |
|
|
$ |
154,201 |
|
|
$ |
1,325,172 |
|
Research
& Development Expenses
|
|
|
2,481,840 |
|
|
|
2,128,096 |
|
|
|
7,857,984 |
|
General
& Administrative Expenses
|
|
|
3,035,680 |
|
|
|
2,629,094 |
|
|
|
10,008,567 |
|
Total
Operating expenses
|
|
|
5,517,520 |
|
|
|
4,757,190 |
|
|
|
17,866,551 |
|
Loss
from Operations
|
|
|
(5,451,784 |
) |
|
|
(4,602,989 |
) |
|
|
(16,541,379 |
) |
Other
Income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(11,263 |
) |
|
|
(607,193 |
) |
|
|
(1,084,483 |
) |
Other
Income
|
|
|
46,629 |
|
|
|
63,406 |
|
|
|
246,457 |
|
Gain
on note retirement
|
|
|
– |
|
|
|
1,532,477 |
|
|
|
1,532,477 |
|
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
|
|
– |
|
|
|
1,159,846 |
|
|
|
(1,642,232 |
) |
Net
loss
|
|
|
(5,416,418 |
) |
|
|
(2,454,453 |
) |
|
|
(17,489,160 |
) |
Dividends
attributable to preferred shares
|
|
|
– |
|
|
|
– |
|
|
|
43,884 |
|
Net
loss applicable to Common Stock
|
|
$ |
(5,416,418 |
) |
|
$ |
(2,454,453 |
) |
|
$ |
(17,533,044 |
) |
Net
loss per share, basic and diluted
|
|
$ |
(0.05 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
Weighted
average number of shares outstanding, basic and diluted
|
|
|
108,715,875 |
|
|
|
46,682,291 |
|
|
|
|
|
The
accompanying notes and the report of independent registered public accounting
firm
should
be read in conjunction with the financial statements.
ADVAXIS,
INC.
(a
development stage company)
STATEMENT
OF SHAREHOLDERS’ EQUITY (DEFICIENCY)
Period
from March 1, 2002 (inception) to October 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Shares
outstanding
|
|
|
|
|
|
Number of
Shares
outstanding
|
|
|
|
|
|
Paid-in
Additional
Capital
|
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
|
Shareholders’
Equity
(Deficiency)
|
|
Preferred
stock issued
|
|
|
3,418 |
|
|
$ |
235,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
235,000 |
|
Common
Stock Issued
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
$ |
40 |
|
|
$ |
(40 |
) |
|
|
|
|
|
0 |
|
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 consultant
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Shares
outstanding
|
|
|
|
|
|
Number of
Shares
outstanding
|
|
|
|
|
|
Paid-in
Additional
Capital
|
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
|
Shareholders’
Equity
(Deficiency)
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
40,238,992 |
|
|
$ |
40,239 |
|
|
$ |
5,914,793 |
|
|
$ |
(9,662,173 |
) |
|
$ |
(3,707,141 |
) |
Balance
at October 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
1,000,000 |
|
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 |
) |
The
accompanying notes and the report of independent registered public accounting
firm
should
be read in conjunction with the financial statements.
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Cash Flows
|
|
Year Ended
October 31, 2008
|
|
|
Year Ended
October 31, 2007
|
|
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(5,416,418 |
) |
|
$ |
(2,454,453 |
) |
|
$ |
(17,489,160 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
charges to consultants and employees for options and stock
|
|
|
355,364 |
|
|
|
786,656 |
|
|
|
1,853,230 |
|
Amortization
of deferred financing costs
|
|
|
- |
|
|
|
177,687 |
|
|
|
260,000 |
|
Non-cash
interest expense
|
|
|
7,907 |
|
|
|
280,060 |
|
|
|
518,185 |
|
(Gain)
Loss on charge in vale of warrants and embedded derivative
|
|
|
- |
|
|
|
(1,159,846 |
) |
|
|
1,642,232 |
|
Value
of penalty shares issued
|
|
|
31,778 |
|
|
|
- |
|
|
|
149,276 |
|
Depreciation
expense
|
|
|
36,137 |
|
|
|
31,512 |
|
|
|
92,090 |
|
Amortization
expense of intangibles
|
|
|
161,208 |
|
|
|
54,577 |
|
|
|
313,511 |
|
Gain
on note retirement
|
|
|
– |
|
|
|
(1,532,477 |
) |
|
|
(1,532,477 |
) |
(Increase)
decrease in prepaid expenses
|
|
|
161,055 |
|
|
|
(161,817 |
) |
|
|
(38,862 |
) |
Decrease
(increase) in other assets
|
|
|
- |
|
|
|
724 |
|
|
|
(3,876 |
) |
Increase
in accounts payable
|
|
|
211,559 |
|
|
|
99,076 |
|
|
|
1,436,062 |
|
(Decrease)
increase in accrued expenses
|
|
|
298,322 |
|
|
|
(217,444 |
) |
|
|
587,158 |
|
(Decrease)
increase in interest payable
|
|
|
- |
|
|
|
(117,951 |
) |
|
|
18,291 |
|
(Decrease)
in Deferred Revenue
|
|
|
- |
|
|
|
(20,350 |
) |
|
|
- |
|
Net
cash used in operating activities
|
|
|
(4,153,088 |
) |
|
|
(4,234,046 |
) |
|
|
(12,194,340 |
) |
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid on acquisition of Great Expectations
|
|
|
- |
|
|
|
- |
|
|
|
(44,940 |
) |
Purchase
of property and equipment
|
|
|
(10,842 |
) |
|
|
(37,632 |
) |
|
|
(137,657 |
) |
Cost
of intangible assets
|
|
|
(200,470 |
) |
|
|
(358,336 |
) |
|
|
(1,525,860 |
) |
Net
cash used in Investing Activities
|
|
|
(211,312 |
) |
|
|
(395,968 |
) |
|
|
(1,708,457 |
) |
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from (repayment of) convertible secured debenture
|
|
|
- |
|
|
|
(2,040,000 |
) |
|
|
960,000 |
|
Cash
paid for deferred financing costs
|
|
|
- |
|
|
|
- |
|
|
|
(260,000 |
) |
Proceeds
from notes payable
|
|
|
475,000 |
|
|
|
600,000 |
|
|
|
1,746,224 |
|
Payment
on notes payable
|
|
|
(14,832 |
) |
|
|
(92,087 |
) |
|
|
(106,919 |
) |
Net
proceeds of issuance of Preferred Stock
|
|
|
- |
|
|
|
- |
|
|
|
235,000 |
|
Payment
on notes payable
|
|
|
- |
|
|
|
(600,000 |
) |
|
|
(600,000 |
) |
Net
proceeds of issuance of Preferred Stock
|
|
|
(78,014 |
) |
|
|
8,042,917 |
|
|
|
11,988,230 |
|
Net
cash provided by Financing Activities
|
|
|
382,154 |
|
|
|
5,910,830 |
|
|
|
13,962,535 |
|
Net
increase in cash
|
|
|
(3,982,246 |
) |
|
|
1,280,816 |
|
|
|
59,738 |
|
Cash
at beginning of period
|
|
|
4,041,984 |
|
|
|
2,761,166 |
|
|
|
- |
|
Cash
at end of period
|
|
$ |
59,738 |
|
|
$ |
4,041,984 |
|
|
$ |
59,738 |
|
The
accompanying notes and the report of independent registered public accounting
firm
should be read in conjunction with
the financial statements.
Supplemental Schedule of
Noncash Investing and Financing Activities
|
|
Year Ended
October 31, 2008
|
|
|
Year Ended
October 31, 2007
|
|
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
Equipment
acquired under notes payable
|
|
$ |
- |
|
|
$ |
45,580 |
|
|
$ |
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 |
|
Notes
payable and accrued interest converted to Common Stock
|
|
$ |
- |
|
|
$ |
1,600,000 |
|
|
$ |
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
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
512,865 |
|
Allocation
of the original secured convertible debentures to warrants
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
214,950 |
|
Warrants
issued in connection with issuance of Common Stock
|
|
$ |
- |
|
|
$ |
1,505,550 |
|
|
$ |
1,505,550 |
|
The
accompanying notes and the report of independent registered public accounting
firm
should
be read in conjunction with the financial statements.
ADVAXIS,
INC.
(a
development stage company)
NOTES
TO FINANCIAL STATEMENTS
1.
|
PRINCIPAL
BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES:
|
Advaxis,
Inc. (the “Company”) was incorporated in 2002 and is a biotechnology company
researching and developing new cancer-fighting techniques. The Company is in the
development stage and its operations are subject to all of the risks inherent in
an emerging business enterprise.
The
preparation of financial statements in accordance with GAAP involves the use of
estimates and assumptions that affect the recorded amounts of assets and
liabilities as of the date of the financial statements and the reported amounts
of revenue and expenses during the reporting period. Actual results may differ
substantially from these estimates. Significant estimates include the fair value
and recoverability of the carrying value of intangible assets (patents and
licenses) the fair value of options, the fair value of embedded conversion
features, warrants, recognition of on-going clinical trial, and related
disclosure of contingent assets and liabilities. On an on-going basis, the
Company evaluates its estimates, based on historical experience and on various
other assumptions that it believes to be reasonable under the circumstances.
Actual results may differ from these estimates under different assumptions or
conditions.
The
Company’s products are being developed and not generated significant revenues.
As a result, the Company has suffered recurring losses and it liabilities exceed
its assets. The Company expects these losses to continue for an extended period
of time. The Company is in default on two notes listed in notes payable. The
Company plans to obtain sufficient financing so it can develop and market its
products. On January 5, 2009, in a letter received from the United States Food
and Drug Administration (“FDA”), the Company was notified that it removed its
clinical hold on its Investigational New Drug Application (“IND”). The Company
will now be able to commence its Phase II cervical intraepithelial neoplasia
(“CIN”) trial. The net proceeds received by the Company from the: $425,000 in
Notes, $922,020 state net operating losses (“NOL”) provided by the New Jersey
Economic Development Administration (“NJEDA”) on December 12, 2008 (see
Note 11) along with are reduction of salaries of the Company’s highly
compensated employees effective as of January 4, 2009 is estimated to be
sufficient to finance operations to March 2009. The Company believes it can
raise $8,500,000 capital in 2009. If successful, these funds should meet
the Company’s financial needs over the next twelve to fifteen months allowing
time to perform one arm of its Phase II CIN trial and to access the potential
outcome of the trial. These events raise substantial doubt about its ability to
continue as a going concern. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
In
accordance with Securities and Exchange Commission (“SEC”) Staff Accounting
Bulletin (“SAB”) No. 104, revenue from license fees and grants is recognized
when the following criteria are met; persuasive evidence of an arrangement
exists, services have been rendered, the contract price is fixed or
determinable, and collectibility is reasonably assured. In licensing
arrangements, delivery does not occur for revenue recognition purposes until the
license term begins. Nonrefundable upfront fees received in exchange for
products delivered or services performed that do not represent the culmination
of a separate earnings process will be deferred and recognized over the term of
the agreement using the straight line method or another method if it better
represents the timing and pattern of performance. Since its inception and
through October 31, 2008 all of the Company’s revenues have been from grants.
For the year ended October 31, 2008 and 2007 all of the Company’s revenues were
received from one grant and two grants, respectively.
For
revenue contracts that contain multiple elements, the Company will determine
whether the contract includes multiple units of accounting in accordance with
EITF No. 00-21, Revenue
Arrangements with Multiple Deliverable . Under that guidance, revenue
arrangements with multiple deliverables are divided into separate units of
accounting if the delivered item has value to the customer on a standalone basis
and there is objective and reliable evidence of the fair value of the
undelivered item.
The
Company maintains its cash in bank deposit accounts (money market) that at times
exceed federally insured limits.
Property
and Equipment
Equipment
is stated at cost. Depreciation and amortization are provided for on a
straight-line basis over the estimated useful life of the asset ranging from 3
to 5 years. Expenditures for maintenance and repairs that do not materially
extend the useful lives of the respective assets are charged to expense as
incurred. The cost and accumulated depreciation or amortization of assets
retired or sold are removed from the respective accounts and any gain or loss is
recognized in operations.
Intangible
assets, which consist primarily of legal and filing costs in obtaining patents
and licenses and are being amortized on a straight-line basis over twenty
years.
Impairment
of Long-Lived Assets
In
accordance with Statement of Financial Accounting Standards No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets”, the Company reviews its
long-lived assets for impairment whenever events and circumstances indicate that
the carrying value of an asset might not be recoverable and its carrying amount
exceeds its fair value, which is based upon estimated undiscounted future cash
flows. For all periods presented, there have been no impairment losses
incurred.Net assets recorded on the balance sheet for patents and licenses
related to ADXS11-001, ADXS31-142, ADXS31-164 and other products are in
development. However, if a competitor were to gain FDA approval for a treatment
before the Company, or if future clinical trials fail to meet the targeted
endpoints, it would likely record an impairment related to these assets. In
addition, if an application is rejected or fails to be issued, the Company would
record an impairment of its estimated book value. In January 2009, the Company
decided to discontinue its use of the Trademark Lovaxin and write-off of its
intangible assets for trademarks resulting in an asset impairment of $91,453 as
of October 31, 2008.
Basic
loss per share is computed by dividing net loss by the weighted-average number
of shares of common stock outstanding during the periods. Diluted earnings per
share gives effect to dilutive options, warrants, convertible debt and
other potential common stock outstanding during the period. Therefore, the
impact of the potential common stock resulting from warrants and outstanding
stock options are not included in the computation of diluted loss per share, as
the effect would be anti-dilutive. The table sets forth the number of potential
shares of common stock that have been excluded from diluted net loss per
share.
|
|
|
|
|
|
|
Warrants
|
|
|
97,187,400 |
|
|
|
87,713,770 |
|
Stock
Options
|
|
|
8,812,841 |
|
|
|
8,512,841 |
|
Total
|
|
|
106,000,241 |
|
|
|
96,226,611 |
|
No
deferred income taxes are provided for the differences between the bases of
assets and liabilities for financial reporting and income tax purposes. Future
ownership changes may limit the future utilization of these net operating loss
and research and development tax credit carry-forwards as defined by the
Internal Revenue Code. The amount of any potential limitation is unknown. The
net deferred tax asset has been fully offset by a valuation allowance due to the
Company’s history of taxable losses and uncertainty regarding its ability to
generate sufficient taxable income in the future to utilize these deferred tax
assets.
The
estimated fair value of the notes payable approximates the principal amount
based on the rates available to the Company for similar debt.
Accounts
payable consists entirely of trade accounts payable.
Research
and development costs are charged to expense as incurred.
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurement. This
statement does not require any new fair value measurement, but it provides
guidance on how to measure fair value under other accounting pronouncements.
SFAS No. 157 also establishes a fair value hierarchy to classify the
source of information used in fair value measurements. The hierarchy prioritizes
the inputs to valuation techniques used to measure fair value into three broad
categories. This standard is effective for the Company beginning fiscal year
ending October 31, 2009. The Company is currently evaluating the impact of this
pronouncement on its financial statements.
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities. SFAS No. 159 permits
companies to choose to measure certain financial instruments and certain other
items at fair value. The election to measure the financial instrument at fair
value is made on an instrument-by-instrument basis for the entire instrument,
with few exceptions, and is irreversible. SFAS No. 159 is effective
for the fiscal year ending October 31, 2009. The Company is currently evaluating
the impact of this pronouncement on its financial statements.
In June,
2008, The FASB ratified Emerging Issues Task Force (EITF) Issue No 07-05, “Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock” (EITF 07-5).
EITF 07-5 mandates a two-step process for evaluating whether an equity-linked
financial instrument or embedded feature indexed to the entity’s own stock. It
is effective for fiscal years beginning after December 15, 2008, and interim
periods within those fiscal years, which is the Company’s first quarter of
fiscal 2010. Many of the warrants issued by the Company contain a strike price
adjustment feature, which upon adoption of EITF 07-5, will result in the
instruments no longer being considered indexed to the Company’s own stock.
Accordingly, adoption of EITF 07-5 will change the current classification (from
equity to liability) and the related accounting for many warrants outstanding at
that date. The Company is currently evaluating the impact the adoption of EITF
07-5 will have on its financial position, results of operation, or cash
flows.
Management
does not believe that any other recently issued, but not yet effective,
accounting standards if currently adopted would have a material effect on the
accompanying financial statements.
2.
|
SHARE-BASED
COMPENSATION EXPENSE
|
The
Company adopted SFAS 123(R) using the modified prospective transition method,
which requires the application of the accounting standard as of November 1,
2005, the first day of the Company’s fiscal year 2006. In accordance with the
modified prospective transition method, the Company’s Financial Statements for
prior periods were not restated to reflect, and do not include the impact of
SFAS 123(R). The Company began recognizing expense in an amount equal to
the fair value of share-based payments (stock option awards) on their date of
grant, over the requisite service period of the awards (usually the vesting
period). Under the modified prospective method, compensation expense for the
Company is recognized for all share based payments granted and vested on or
after November 1, 2005 and all awards granted to employees prior to
November 1, 2005 that were unvested on that date but vested in the period over
the requisite service periods in the Company’s Statement of Operations. Prior to
the adoption of the fair value method, the Company accounted for stock-based
compensation to employees under the intrinsic value method of accounting set
forth in Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to
Employees , and related interpretations. Therefore, compensation expense
related to employee stock options was not reflected in operating expenses in any
period prior to the fiscal year of 2006 and prior period results have not been
restated. Since the date of inception to October 31, 2005 had the Company
adopted the fair value based method of accounting for stock-based employee
compensation under the provisions of SFAS No. 123, Stock Option Expense
would have totaled $328,176 for the period March 1, 2002 (date of inception) to
October 31, 2008, and the effect on the Company’s net loss would have been as
follows:
|
|
March 1, 2002
(date of inception)
to October 31,
2008
|
|
Net
Loss as reported
|
|
$ |
(17,489,160 |
) |
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
|
|
$ |
(17,728,119 |
) |
The fair
value of each option granted from the Company’s stock option plans during the
years ended October 31, 2007 and 2008 was estimated on the date of grant using
the Black-Scholes option-pricing model. Using this model, fair value is
calculated based on assumptions with respect to (i) expected volatility of
the Company’s Common Stock price, (ii) the periods of time over which employees
and Board Directors are expected to hold their options prior to exercise
(expected lives), (iii) expected dividend yield on the Company’s Common
Stock, and (iv) risk-free interest rates, which are based on quoted U.S.
Treasury rates for securities with maturities approximating the options’
expected lives. Expected volatility for a development stage biotechnology
company is very difficult to estimate as such; the company considered several
factors in computing volatility. The company used their own historical
volatility in determining the volatility to be used. Expected lives are based on
contractual terms given the early stage of the business, lack of intrinsic value
and significant future dilution along typical of early stage biotech. The
expected dividend yield is zero as the Company has never paid dividends and does
not currently anticipate paying any in the foreseeable future.
|
|
Year Ended
October 31,
2008
|
|
|
Year Ended
October 31,
2007
|
|
Expected
volatility
|
|
|
110.1 |
% |
|
|
119 |
% |
Expected
Life
|
|
5.9
years
|
|
|
7.0
years
|
|
Dividend
yield
|
|
|
0 |
|
|
|
0 |
|
Risk-free
interest rate
|
|
|
3.60 |
% |
|
|
4.3 |
% |
Stock-based
compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that vested during the period. Stock-based
compensation expense for the fiscal year ended October 31, 2008 includes
compensation expense for share-based payment awards granted prior to, but not
yet vested as of October 31, 2005 based on the grant date fair value
estimated in accordance with the provisions of SFAS 123 and compensation expense
for the share-based payment awards granted subsequent to October 31, 2005 based
on the grant date fair value estimated in accordance with the provisions of SFAS
123(R). Compensation expense for all share-based payment awards to be recognized
using the straight line method over the requisite service period. As stock-based
compensation expense for the twelve months of 2007 and 2008 is based on awards
granted and vested, it has been reduced for estimated forfeitures (4.4%). SFAS
123(R) requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates. In the Company’s pro forma information required under SFAS 123 for
the periods prior to fiscal 2006, the Company accounted for forfeitures as they
occurred.
Warrant
Expense
Pursuant
to the November 21, 2007 Letter of Agreement between Crystal Research Associates
and Advaxis, Inc. the Company issued 400,000 warrants expiring in four years to
purchase Advaxis stock at $0.20 per share and $40,000 for providing a fee-based
research document. The Company recorded a fair value of $39,198 in Fiscal 2008.
In addition, the Company accrued for the 475,000 warrants earned but not be
issued from Mr. Moore’s Note of $475,000 per the terms and conditions of the
Note he earned one warrant for each $1.00 loaned. The fair market value recorded
in fiscal 2008 period of $16,340 was based on the Advaxis common stock closing
price as of October 31, 2008 or $0.04.
On or
about the October 17, 2007 (the closing date of the private placement) the
following transactions took place:
Pursuant
to the related Placement Agency Agreement with Carter Securities, LLC, the
Company paid the placement agent $354,439 in cash commissions and reimbursement
of expenses and issued to it 2,949,333 warrants exercisable at $0.20 per share.
The fair value of the warrants is estimated to be $574,235. The fair value of
the warrants was calculated using the black-scholes valuation model with the
following assumptions: 2,949,333 warrants, market price of common stock on the
date of sale of $0.23 per share October 17, 2007, exercise price of $0.20,
risk-free interest rate of 4.16%, expected volatility of 119% and expected life
of 5 years. The value of the warrants and cash are included in APIC as a
reduction to net proceeds from the October 2007 private placement.
In
accordance with a consulting agreement with Centrecourt Asset Management they
were paid $328,000 in cash commissions and issued 2,483,333 warrants exercisable
at $0.20 per share. The fair value of the warrants is estimated to be $483,505.
The fair value of the warrants was calculated using the black-scholes valuation
model with the following assumptions: 2,483,333 warrants, market price of common
stock on the date of sale of $0.23 per share on October 17, 2007, an exercise
price of $0.20, risk-free interest rate of 4.16%, expected volatility of 119%
and expected life of 5 years. The value of the warrants and one half of the cash
was included in APIC as a reduction to net proceeds from the October 2007
private placement. The other half of the cash was recorded as prepaid expense
for advisory consulting services to be amortized over the balance of the term of
the one- year agreement.
In
accordance with a consulting agreement with BridgeVentures they were paid
$51,427 in cash commissions and issued 800,000 warrants exercisable at $0.20 per
share. The fair value of the warrants is estimated to be $155,760. The fair
value of the warrants was calculated using the black-scholes valuation model
with the following assumptions: 800,000 warrants, market price of common stock
on the date of sale of $0.23 per share on October 17, 2007, an exercise price of
$0.20, risk-free interest rate of 4.16%, expected volatility of 119% and
expected life of 5 years. The value of the warrants and the cash was included in
APIC as a reduction to net proceeds from the October 2007 private placement. The
future consulting payments of cash will recorded as consulting expense for
advisory consulting services over the balance of the agreement.
In
accordance with a consulting agreement with Dr. Filer, he was issued 1,500,000
warrants exercisable at $0.20 per share. The fair value of the warrants is
estimated to be $292,050. The fair value of the warrants was calculated using
the black-scholes valuation model with the following assumptions: 1,500,000
warrants, market price of common stock on the date of sale of $0.23 per share on
October 17, 2007, an exercise price of $0.20, risk-free interest rate of 4.16%,
expected volatility of 119% and expected life of 5 years. The value of the
warrants was included in APIC as a reduction to net proceeds from the October
2007 private placement. He receives a monthly fee of $5,000 for consulting
recorded as consulting expense for advisory consulting services over the balance
of the agreement.
The
Company accounts for nonemployee stock-based awards in which goods or services
are the consideration received for the equity instruments issued based on the
fair value of the equity instruments in accordance with the guidance provided in
the consensus opinion of the Emerging Issues Task Force (“EITF”) Issue 96-18,
Accounting for Equity
Instruments that Are Issued to Other than Employees for Acquiring, or in
Conjunction With Selling Goods or Services.
Intangible
assets consist of legal and filing costs associated with obtaining patents, and
licenses which are amortized on a straight-line basis over their remaining
useful lives, which are estimated to be twenty years. Capitalized license costs
represent the value assigned to the Company’s twenty year exclusive worldwide
license with the Penn. The value of the license is based on management’s
assessment regarding the ultimate recoverability of the amounts paid and the
potential for alternative future uses. This license includes the exclusive right
to exploit twelve issued and 67 pending patents according to the signing of
Second Amendment and Restated Agreement payment. The Company exercised its
option under the Second Amended and Restated Patent License Agreement to license
a majority of these pending patents for a fee of $297,000. As of October
31, 2008, all gross capitalized costs associated with licenses, patents filed
and granted as well as costs associated with patents pending are $1,342,825 as
shown under license and patents on the table below. The $1,342,825 includes the
capitalized cost of the patents and licenses issued of $624,324 and the costs
associated with patents pending of $718,501. The expirations of the existing
patents issued range from 2014 to 2020. Capitalized costs associated with patent
applications that are abandoned are charged to expense when the determination is
made not to pursue the application. Amortization expense for licensed technology
and capitalized patent cost is included in general and administrative costs.
There have been no patent applications abandoned and charged to expense in the
current or prior year that were material in value. In January 2009 the company
made the decision to discontinue its use of Trademark Lovaxin and write-off of
its intangible assets for trademarks resulting in an asset impairment loss of
$91,453 as of October 31, 2008.
Under the
Amended and Restated Agreement the Company is billed actual legal and filing
costs as they are passed through from Penn. Intangible assets consist of the
following at:
|
|
October 31, 2008
|
|
October 31, 2007
|
|
Trademarks |
|
|
- |
|
|
87,857
|
|
Patents
|
|
$ |
812,910 |
|
|
663,283
|
|
License
|
|
|
529,915 |
|
|
496,127
|
|
Less:
Accumulated Amortization
|
|
|
(205,428 |
) |
|
(149,132
|
) |
|
|
$ |
1,137,397 |
|
$ |
1,098,135
|
|
Estimated
amortization expense is as follows:
Year ending October 31,
|
|
|
|
2009
|
|
$ |
70,000 |
|
2010
|
|
|
70,000 |
|
2011
|
|
|
70,000 |
|
2012
|
|
|
70,000 |
|
2013
|
|
|
70,000 |
|
Amortization
expense of intangibles amounted to $69,755 and $54,577 for the year ended
October 31, 2008 and 2007, respectively
The
following table represents the major components of accrued
expenses:
|
|
October 31, 2008
|
|
October 31, 2007
|
|
Salaries
and other compensation
|
|
$ |
430,256 |
|
|
182,737
|
|
Sponsored
Research Agreement
|
|
|
119,698 |
|
|
-
|
|
Consultants
|
|
|
24,000 |
|
|
84,619
|
|
Warrants
|
|
|
16,340 |
|
|
-
|
|
Clinical
Research Organization
|
|
|
11,166 |
|
|
37,667
|
|
Other
|
|
|
1,885 |
|
|
-
|
|
|
|
$ |
603,345 |
|
$ |
305,023
|
|
Notes
payable consist of the following at:
|
|
|
October 31, 2008
|
|
|
October 31, 2007
|
|
Two
notes payable with interest at 8% per annum, due on December 17,
2008. The lender has served notice demanding repayment on the due
date pursuant to the November 2004 recapitalization and financing
agreement. The notes have not been paid as of January 29,
2009
|
|
$ |
69,588 |
|
|
65,577
|
|
Notes
payable (Mr. Moore) with interest at 12% per annum compounded
quarterly
|
|
|
478,897 |
|
|
-
|
|
Installment
purchase agreement on equipment with interest at 11.75% per
annum
|
|
|
19,645 |
|
|
34,478
|
|
Total
|
|
|
568,130 |
|
|
100,055
|
|
Less
current portion
|
|
|
(563,317 |
) |
|
(80,409
|
) |
|
|
$ |
4,813 |
|
$ |
19,646
|
|
As of
October 31, 2008 and pursuant to the Agreement, Mr. Moore has loaned the Company
$475,000. Mr. Moore informed the Company that based on the funds generated by
the NOL received on December 12, 2008 (see Note 11) and personal considerations
that he may not make full funding. On December 15, 2008 the Board
approved an amendment of the Agreements repayment terms from February 15, 2009
to June 15, 2009. In consideration for revising the repayment term the Company
repaid Mr. Moore $50,000 from the $475,000 outstanding Notes thus reducing the
balance to $425,000.
6.
|
SECURED
CONVERTIBLE DEBENTURE:
|
Pursuant
to a Securities Purchase Agreement dated February 2, 2006 ($1,500,000 principal
amount) and March 8, 2006 ($1,500,000 principal amount) the Company issued to
Cornell Capital Partners, LP (“Cornell”) $3,000,000 principal amount of the
Company’s Secured Convertible Debentures due February 1, 2009 (the “Debentures”)
at face amount, and five year Warrants to purchase 4,200,000 shares of Common
Stock at the price of $0.287 per share and five year B Warrants to purchase
300,000 shares of Common Stock at a price of $0.3444 per share.
The
Debentures were convertible at a price equal to the lesser of (i) $0.287 per
share (“Fixed Conversion Price”), or (ii) 95% of the lowest volume weighted
average price of the Common Stock on the market on which the shares were listed
or traded during the 30 trading days immediately preceding the date of
conversion (“Market Conversion Price”). Interest was payable at maturity at the
rate of 6% per annum in cash or shares of Common Stock valued at the conversion
price then in effect.
Cornell
agreed that (i) it would not convert the Debenture or exercise the Warrants if
the effect of such conversion or exercise would result in its and its
affiliates’ holdings of more than 4.9% of the outstanding shares of Common
Stock, (ii) neither it nor its affiliates would maintain a short position or
effect short sales of the Common Stock while the Debentures are outstanding, and
(iii) no more than $300,000 principal amount of the Debenture could be converted
at the Market Conversion Price during a calendar month.
The
Company could call the Debentures for redemption at the Redemption Price at any
time or from time to time but not more than $500,000 principal amount could be
called during any 30 consecutive day period. The Redemption Price would be 120%
of the principal redeemed plus accrued interest. The Company also granted the
holder an eighteen-month right of first refusal assuming the Debentures were
still outstanding with respect to the Company’s issuance or sale of shares of
capital stock, options, warrants or other convertible securities. Pursuant to
Registration Rights Agreement, the Company registered at its expense under the
Securities Act for reoffering by the holders of the Debentures and of the
Warrants and B Warrants shares of Common Stock received upon conversion or
exercise.
The
Company granted the holders a first security interest on its assets as security
for payment of the Company’s obligations.
The
Company also agreed that as long as there was outstanding at least $500,000
principal amount of Debentures it would not, without the consent of the
Debenture holder, issue or sell any securities at a price or warrants, options
or convertible securities with an exercise or conversion price less than the bid
price, as defined, immediately prior to the issuance; grant a further security
interest in its assets or file a registration statement on Form
S-8.
In the
event of a Debenture default the Debenture would, at the holder’s election,
become immediately due and payable in cash or, at the holder’s option, could be
converted into shares of Common Stock. Events of default included failure to pay
principal when due or interest within five days following due date; failure to
cure breaches or defaults of covenants, agreements or warrants within 10 days
following written notice of such breach or default; the entry into a change of
control transaction meaning (A) the acquisition of effective control of more
than 50% of the outstanding voting securities by an individual or group (not
including the holder or its affiliates), or (B) the replacement of more than
one-half of the Directors not approved by a majority of the Company’s directors
as of February 2, 2006 or by directors appointed by such directors or (C) the
Company entering into an agreement to effect any of the foregoing; bankruptcy or
insolvency acts; breach or default which results in acceleration of the maturity
of other debentures, mortgages or credit facilities, indebtedness or factor
agreements involving outstanding principal of at least $100,000; breach of the
Registration Rights Agreement as to the maintaining effectiveness of the
registration statement which results in an inability to sell shares by holder
for a designated period; failure to maintain the eligibility of the Common Stock
to trade on at least the Over-the-Counter Bulletin Board, and failure to make
delivery within five trading days of certificates for shares to be issued upon
conversion or the date the Company publicly announced its intention not to
comply with requests for conversion in accordance with the Debenture
terms.
Debenture
Accounting
The
Debentures were settled in October 2007. In accounting for the Debentures and
the warrants described above the Company considered the guidance contained in
EITF 00-19, “Accounting for
Derivative Financial Instruments Indexed To, and Potentially Settled In, a
Company’s Own Common
Stock,” and SFAS 133 “Accounting for Derivative
Instruments and Hedging Activities.” In accordance with the guidance
provided in EITF 00-19, the Company determined that the conversion feature of
the convertible debentures represented an embedded derivative since the
debenture was convertible into a variable number of shares based upon the
conversion formula which could require the Company to issue shares in excess of
its authorized amount. The convertible debentures were not considered to be
“conventional” convertible debt under EITF 00-19 and thus the embedded
conversion feature must be bifurcated from the debt host and accounted for as a
derivative liability.
The
Company continued to measure the fair value of the warrants and embedded
conversion features at each reporting date using the Black-Scholes valuation
model based on the current assumptions at that point in time. This calculation
resulted in a fair market value significantly different than previous reporting
periods. The increase or decrease in the fair market value of the warrants and
embedded conversion feature at each period resulted in a non-cash income or loss
to the other income or loss line item in the Statement of Operations along with
a corresponding change in liability.
The
Company was required to measure the fair value of the warrants calculated using
the Black-Scholes valuation model on the date of each reporting period until the
debt was extinguished. On October 31, 2006 the fair value of the warrants was
calculated by using the Black-Scholes valuation model with the following
assumptions: (i) 4,200,000 warrants at market price of common stock on the date
of sale of $0.20 per share, exercise price of $0.287 and (ii) 300,000 warrants
at the market price of common stock of $0.20 per share, exercise price of
$0.3444 both at risk-free interest rate of 4.56%, expected volatility of 122%
and expected life of 4.33 years. The fair value of the warrants was $714,600 or
an increase of $499,650 over the $214,950 recorded at inception. This increase
of the fair value of the warrants was charged to the Statements of Operations as
expenses to Net Change in Fair Value of Common Stock Warrant and Embedded
Derivative Liability and credited to Balance Sheet: Common Stock Warrants
Liabilities. On October 17, 2007 the value of the warrants increased by $15,240
over the $714,600 fair value as of October 31, 2006 to a fair value of $729,840.
The Company purchased the warrants on October 17, 2007 for $600,000 and recorded
a gain on extinguishment of $129,840.
Likewise
the Company was also required to measure the fair value of the embedded
conversion feature allocated to the Debentures liability based upon the
Black-Scholes valuation model on the date of each reporting period. On October
31, 2006 the fair value of this feature was based on the following assumptions:
(i) the market price convertible at the price equal to 95% of the lowest volume
weighted average price of the Common Stock on the market on which the shares are
listed or traded during the 30 trading days immediately preceding the date of
conversion or $0.141 on October 31, 2006, (ii) the conversion price of $0.20,
(iii) the risk free interest rate of 4.62%, (iv) expected volatility of 127.37%
and (v) expected life of 2.333 years. The fair value of the embedded conversion
feature was $2,815,293 or an increase of $2,302,428 over the $512,865 recorded
at inception. This increase of the fair value of the embedded conversion feature
was charged to the Statements of Operations expensed as Net Change in Fair Value
of Common Stock Warrant and Embedded Derivative Liability and credited to
Balance Sheet was credited to the Embedded Derivative Liability. On October 17,
2007 the value of the embedded derivative decreased by $1,175,086 from the
$2,815,293 fair value as of October 31, 2006 to a fair value of $1,640,207. The
Company purchased the Debenture on October 17, 2007 for $340,000 Premium over
the principal but still recorded a gain on extinguishment of
$1,300,207.
The
Company was required to measure the fair value of the warrants and the embedded
conversion feature to be calculated using the Black-Scholes valuation model on
the date of each reporting period until the debt was extinguished. The Company
allocated the proceeds from the sale of the Debentures between the relative fair
values at the date of origination of the sale for the warrants, embedded
derivative and the debenture. The fair value of the warrants was calculated by
using the Black-Scholes valuation model with the following assumptions: (i)
4,200,000 warrants at market price of common stock on the date of sale of $0.21
per share, exercise price of $0.287 and (ii) 300,000 warrants at the market
price of common stock of $0.21 per share, exercise price of $0.3444 both at
risk-free interest rate of 4.5%, expected volatility of 25% and expected life of
five years. The initial fair value of the warrants of $214,950 was recorded as a
reduction to the Debenture liability and will be amortized over the loan period
and charged to interest expense. The portion of the fair value of the warrants
charged to interest expense since inception to October 17, 2007 (extinguishment)
was $122,803 the $92,147 balance partially offset gain on
extinguishment.
The fair
value of the embedded conversion feature allocated to the Debentures liability
was based on the Black-Scholes valuation model with the following
assumptions: (i) the market price convertible at the price equal to 95% of the
lowest volume weighted average price of the Common Stock on the market on which
the shares are listed or traded during the 30 trading days immediately preceding
the date of conversion or $0.2293 on the date of origination (most beneficial
conversion rate), (ii) the conversion price of $0.287, (iii) the risk free
interest rate of 4.5%, (iv) expected volatility of 30% and (v) expected life of
three years. The initial fair value of the embedded conversion feature of
$512,865 was recorded as a reduction to the Debenture liability and will be
amortized over the loan period and charged to interest expense. The portion of
the fair value of the embedded conversion feature charged to interest expense
since inception to October 17, 2007 (extinguishment) was $387,477. The $125,388
balance partially offsets the gain on extinguishments.
The
Company paid Yorkville Advisor, LLC a fee of 8% of the principal amount of the
Debentures sold or $240,000 and structuring and due diligence fees of $15,000
and $5,000, respectively. The amount paid to Yorkville Advisor, LLC in
connection with the Debentures was capitalized and charged to interest expense
over the three-year term of the Debentures since Yorkville is related to the
holders of the Debentures by virtue of common ownership. The amount charged as
interest since inception to October 17, 2007 was $196,272 however, the
balance was written off to interest due to early extinguishment of the debt
amounting to $260,000.
Debenture
Extinguishments
At the
closing of this private placement, the Company exercised its right under an
agreement dated August 23, 2007 with YA Global Investments, L.P. f/k/a Cornell
Capital Partners, L.P. (“Yorkville”), to redeem the outstanding $1,700,000
principal amount of the Company’s Secured Convertible Debentures due February 1,
2009 owned by Yorkville, and to acquire from Yorkville warrants expiring
February 1, 2011 to purchase an aggregate of 4,500,000 shares of the Company’s
common stock. The Company paid an aggregate of (i) $2,289,999 to redeem the
debentures at the principal amount plus a 20% premium of accrued and unpaid
interest, and (ii) $600,000 to repurchase the warrants.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embedded
Derivative
Liability
$
|
|
Original
(Fiscal Year 2006)
|
|
|
3,000,000 |
|
|
|
(727,815 |
)
(1) |
|
|
– |
|
|
|
– |
|
|
|
– |
|
Fiscal
year 2006
|
|
|
(300,000 |
)
(2) |
|
|
230,218 |
(3) |
|
|
119,934 |
|
|
|
714,600 |
(4) |
|
|
2,815,293 |
(4) |
Book
Value at October 31, 2006
|
|
|
2,700,000 |
|
|
|
(497,597 |
) |
|
|
119,934 |
|
|
|
714,600 |
|
|
|
2,815,293 |
|
Fiscal
year 2007
|
|
|
(1,000,000 |
)
(2) |
|
|
280,062 |
(3) |
|
|
130,065 |
|
|
|
15,240 |
(5) |
|
|
(1,175,086 |
)
(5) |
Cash
paid at October 17, 2007
|
|
|
(1,700,000 |
) |
|
|
– |
|
|
|
(249,999 |
) |
|
|
(600,000 |
) |
|
|
(340,000 |
) |
Gain
(Loss)
|
|
|
- |
|
|
|
(217,535 |
) |
|
|
– |
|
|
|
129,840 |
|
|
|
1,300,207 |
|
|
|
|
|
|
|
(1) Embedded
derivative’s warrant value at origination of debenture.
(2) Principal
converted into common stock.
(3) Amortized
discount to interest expense.
(4) Change
in fair value of the Company’s common stock warrants from inception
expensed to the statement of operations.
(5) Change
in fair value for fiscal 2007 until extinguishment.
|
|
The
$1,300,000 principal was converted into 8,741,105 shares of Advaxis, Inc. common
stock at an average value of $0.1487 per share.
As of
October 31, 2007, the Company reported a net gain on extinguishment of
$1,212,512 resulting from the elimination of the warrant liability of $729,840
and the embedded derivative liability of $1,640,207 less the premium paid for
the early extinguishment of $340,000 and $600,000 paid for the elimination of
all warrants and the write-off of the discount.
Penn and
the Company entered into the amended and restated license agreement on February
13, 2007 that eliminated the $482,000 obligation under the prior agreement. This
obligation was recorded in fiscal year 2005 as an intangible asset and as of
January 31, 2007 it remained as an intangible asset with the liabilities
recorded as: a notes payable-current portion $130,000, notes payable-net of
current portion $230,000 and the balance as accounts payable. As a result of
this transaction, $319,967 was recorded as a gain on note retirement and
was reflected in other income in fiscal 2007.
7. STOCK
OPTIONS:
2004 Stock Option
Plan
In
November 2004, the Company’s board of directors adopted and stockholders
approved the 2004 Stock Option Plan (“2004 Plan”). The 2004 Plan provides
for the grant of options to purchase up to 2,381,525 shares of its common stock
to employees, officers, directors and consultants. Options may be either
“incentive stock options” or non-qualified options under the Federal tax laws.
Incentive stock options may be granted only to its employees, while
non-qualified options may be issued, in addition to employees, to non-employee
directors, and consultants. Except as determined by the Administrator at the
time of the grant of the Options, a participant Options vest over four years,
twenty-five percent of the granted amount on or after the first year anniversary
of the date of the granting of an Options and the balance to vest an additional
one twelfth of the Options granted for each additional three-month period
following the first anniversary over a next three years.
The 2004
Plan is administered by “disinterested members” of the board of directors or the
Compensation Committee, who determine, among other things, the individuals who
shall receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market price value per
share of common stock on the date the option is granted. The per share exercise
price of the common stock subject to a non-qualified option may be established
by the board of directors, but shall not, however, be less than 85% of the fair
market value per share of common stock on the date the option is granted. The
aggregate fair market value of common stock for which any person may be granted
incentive stock options which first become exercisable in any calendar year may
not exceed $100,000 on the date of grant.
The
Company must grant options under the 2004 Plan within ten years from the
effective date of the 2004 Plan. The effective date of the Plan was November 12,
2004. Subject to a number of exceptions, holders of incentive stock options
granted under the Plan cannot exercise these options more than ten years from
the date of grant. Options granted under the 2004 Plan generally provide for the
payment of the exercise price in cash and may provide for the payment of the
exercise price by delivery to the Company of shares of common stock already
owned by the optionee having a fair market value equal to the exercise price of
the options being exercised, or by a combination of these methods. Therefore, if
it is provided in an optionee’s options, the optionee may be able to tender
shares of common stock to purchase additional shares of common stock and may
theoretically exercise all of his stock options with no additional investment
other than the purchase of his original shares. As of October 31, 2008 all
options were granted.
2005 Stock Option
Plan
In June
2006, the Company’s board of directors adopted and stockholders approved on June
6, 2006, the 2005 Stock Option Plan (“2005 Plan”).
The 2005
Plan provides for the grant of options to purchase up to 5,600,000 shares of the
Company’s common stock to employees, officers, directors and consultants.
Options may be either “incentive stock options” or non-qualified options under
the Federal tax laws. Incentive stock options may be granted only to the
Company’s employees, while non-qualified options may be issued to non-employee
directors, consultants and others, as well as to the Company’s
employees.
The 2005
Plan is administered by “disinterested members” of the board of directors or the
compensation committee, who determine, among other things, the individuals who
shall receive options, the time period during which the options may be partially
or fully exercised, the number of shares of common stock issuable upon the
exercise of each option and the option exercise price.
Subject
to a number of exceptions, the exercise price per share of common stock subject
to an incentive option may not be less than the fair market value per share of
common stock on the date the option is granted. The per share exercise price of
the common stock subject to a non-qualified option may be established by the
board of directors, but shall not, however, be less than 85% of the fair market
value per share of common stock on the date the option is granted. The aggregate
fair market value of common stock for which any person may be granted incentive
stock options which first become exercisable in any calendar year may not exceed
$100,000 on the date of grant.
The
Company must grant options under the 2005 Plan within ten years from the
effective date of the 2005 Plan. The effective date of the Plan was January 1,
2005. Subject to a number of exceptions, holders of incentive stock options
granted under the 2005 Plan cannot exercise these options more than ten years
from the date of grant. Options granted under the 2005 Plan generally provide
for the payment of the exercise price in cash and may provide for the payment of
the exercise price by delivery to the Company of shares of common stock already
owned by the optionee having a fair market value equal to the exercise price of
the options being exercised, or by a combination of these methods. Therefore, if
it is provided in an optionee’s options, the optionee may be able to tender
shares of common stock to purchase additional shares of common stock and may
theoretically exercise all of his stock options with no additional investment
other than the purchase of his original shares. As of October 31, 2008 there
were 170,083 options that were not granted.
On
November 12, 2004, in connection with the recapitalization (see Note 9), the
options granted under the 2002 option plan were canceled, and employees and
consultants were granted options of Advaxis under the 2004 plan. The
cancellation and replacement had no accounting consequence since the aggregate
intrinsic value of the options immediately after the cancellation and
replacement was not greater than the aggregate intrinsic value immediately
before the cancellation and replacement, and the ratio of the exercise price per
share to the fair value per share was not reduced. Additionally, the original
options were not modified to accelerate vesting or extend the life of the new
options. The table provided in this Note 6 reflects the options on a post
recapitalization basis.
A summary
of the grants, cancellations and expirations (none were exercised) of the
Company’s outstanding options for the periods starting with October 31, 2006
through October 31, 2008 is as follows:
|
|
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Life In
Years
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding
as of October 31, 2006
|
|
|
6,959,077 |
|
|
$ |
0.25 |
|
|
|
8.1 |
|
|
|
18,867 |
|
Granted
|
|
|
2,910,001 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
- |
|
Cancelled
or Expired
|
|
|
(1,356,237 |
) |
|
$ |
0.22 |
|
|
|
|
|
|
|
- |
|
Outstanding
as of October 31, 2007
|
|
|
8,512,841 |
|
|
$ |
0.22 |
|
|
|
7.8 |
|
|
|
167,572 |
|
Granted
|
|
|
300,000 |
|
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
Cancelled
or Expired
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
Outstanding
as of October 31, 2008
|
|
|
8,812,841 |
|
|
$ |
0.22 |
|
|
|
6.3 |
|
|
$ |
- |
|
Vested
& Exercisable at October 31, 2008
|
|
|
7,399,563 |
|
|
$ |
0.22 |
|
|
|
6.2 |
|
|
$ |
- |
|
The
fair value of options granted for the year ended October 31, 2008 amounted to
$25,650
The
following table summarizes significant ranges of outstanding and exercisable
options as of October 31, 2008 (number outstanding and exercisable in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
$ |
0.09-0.10 |
|
|
|
300 |
|
|
9.4
|
|
|
$ |
0.09 |
|
|
$ |
– |
|
|
|
– |
|
|
$ |
– |
|
|
$ |
– |
|
|
|
0.14-0.17 |
|
|
|
3,150 |
|
|
8.1
|
|
|
|
0.15 |
|
|
|
– |
|
|
|
2,519 |
|
|
|
0.15 |
|
|
|
– |
|
|
|
0.18-0.21 |
|
|
|
1,739 |
|
|
5
|
|
|
|
0.21 |
|
|
|
– |
|
|
|
1,705 |
|
|
|
0.21 |
|
|
|
– |
|
|
|
0.22-0.25 |
|
|
|
310 |
|
|
7.5
|
|
|
|
0.25 |
|
|
|
– |
|
|
|
173 |
|
|
|
0.24 |
|
|
|
– |
|
|
|
0.26-0.29 |
|
|
|
2,992 |
|
|
6.6
|
|
|
|
0.28 |
|
|
|
– |
|
|
|
2,681 |
|
|
|
0.28 |
|
|
|
– |
|
|
|
0.30-0.43 |
|
|
|
322 |
|
|
4.3
|
|
|
|
0.37 |
|
|
|
– |
|
|
|
322 |
|
|
|
0.37 |
|
|
|
– |
|
Total |
|
|
|
8,813 |
|
|
6.3
|
|
|
$ |
0.22 |
|
|
$ |
– |
|
|
|
7,400 |
|
|
$ |
0.22 |
|
|
$ |
– |
|
The
aggregate intrinsic value in the preceding table represents the total pretax
intrinsic value, based on options with an exercise price less than the Company’s
closing stock price of $0.04 as of October 31, 2008 which would have been
received by the option holders had those option holders exercised their options
as of that date.
A summary
of the status of the Company’s nonvested shares as of October 31, 2008, and
changes during the year ended October 31, 2008 are presented below:
|
|
|
|
|
Weighted
Average
Exercise
Price at
Grant
Date
|
|
|
Weighted
Average
Remaining
Contractual
Term
(in
years)
|
|
Non-vested
shares at October 31, 2006
|
|
|
3,203,167 |
|
|
$ |
0.25 |
|
|
|
9.0 |
|
Options
granted
|
|
|
2,910,001 |
|
|
$ |
0.15 |
|
|
|
8.9 |
|
Options
vested
|
|
|
(3,032,863 |
) |
|
$ |
0.19 |
|
|
|
8.5 |
|
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, 1008
|
|
|
1,413,278 |
|
|
$ |
0.18 |
|
|
|
7.5 |
|
As of
October 31, 2008, there was approximately $183,009 of unrecognized compensation
cost related to non-vested stock option awards, which is expected to be
recognized over a remaining average vesting period of 1.3 years.
8. COMMITMENTS
AND CONTINGENCIES:
Pursuant
to multiple consulting agreements and a licensing agreement, the Company is
contingently liable for the following:
Under an
amended and restated 20-year exclusive worldwide (July 1, 2002 effective date)
license agreement, the Company is obligated to pay (a) $525,000 in aggregate,
divided over a three-year period as a minimum royalty after the first commercial
sale of a product. Such payments are not anticipated within the next five years.
(b) On December 31, 2008 the Company is also obligated to pay annual license
maintenance fees of $50,000 increasing to a maximum of $100,000 per year until
the first commercial sale of a licensed product. As of the date of this filing
the Company did not pay this fee. (c) Upon the initiation of a Phase III
clinical trial and the regulatory approval for the first Licensor
product the Company is obligated to pay milestone payments of $400,000 and
$600,000, respectively. (d) Upon the achievement of the first sale of a product
in certain fields, the Company shall be obligated to pay certain milestone
payments, as follows: $2,500,000 shall be due for first commercial sale of the
first product in the cancer field (of which $1,000,000 shall be paid within
forty-five (45) days of the date of the first commercial sale, $1,000,000 shall
be paid on the first anniversary of the first commercial sale; and $500,000
shall be paid on the second anniversary of the date of the first commercial
sale). In addition, $1,000,000 shall be due and payable within forty-five (45)
days following the date of the first commercial sale of a product in each
of the following fields (a) infectious disease, (b) allergy, (c) autoimmune
disease, and (d) any other therapeutic indications for which licensed products
are developed. Therefore, the maximum total potential amount of milestone
payments is $3,500,000 in a cancer field. The milestone payments related to
first sales are not expected prior to obtaining a regulatory approval to market
and sell the Company’s vaccines, and such regulatory approval is not expected
within the next 5 years. In addition, the Licensor is entitled to receive a
non-refundable $157,134 payment of historical license costs. Under a licensing
agreement, the Licensor is also entitled to receive royalties of 1.5% on net
sales in all countries. In addition, the Company is obligated to
reimburse the Licensor for all attorneys fees, expenses, official fees and
other charges incurred in the preparation, prosecution and maintenance
of the patents licensed from the Licensor.
Also
pursuant to the Company’s restated and amended license agreement, the Company’s
option terms to license from the Licensor any new future invention conceived by
either Dr. Paterson or Dr. Fred Frankel in the vaccine area were extended until
June 17, 2009. The Company intends to expand its intellectual property base
by exercising this option and gaining access to such future inventions. Further,
its consulting agreement with Dr. Paterson provides, among other things, that,
to the extent that Dr. Paterson’s consulting work results in new inventions,
such inventions will be assigned to Licensor, and we will have access to those
inventions under license agreements to be negotiated. With each license (or
docket and, there can be several patents per docket) an initiation fee up to
$10,000 each can be negotiated. The Company exercised the option under this
agreement twice resulting in approximately 50 patent applications. The license
fees, legal expense, and other filing expenses for such applications cost
approximately $376,000.
Under a
consulting agreement with the Company’s scientific inventor, the Company is
obligated to pay $3,000 per month until the Company closes a $3,000,000 equity
financing, $5,000 per month pursuant to a $3,000,000 equity financing, $7,000
per month pursuant to a $6,000,000 equity financing, and $9,000 per month
pursuant to a $9,000,000 equity financing. Currently the scientific inventor is
earning $7,000 per month based on the agreement and milestones
achieved.
Pursuant
to a Clinical Research Service Agreement, the Company is obligated to pay
service fees totaling of $697,000. As of October 31, 2008, the Company paid
$440,650 toward the $697,000 portion of the agreement. In total the pass-through
expenses was $119,346 and patient cost ran $135,272 in addition to the $697,000
service fees for a total of $951,618.
The
Company is obligated under a non-cancelable operating lease for laboratory and
office space expiring in May 31, 2009 with aggregate future minimum
payments due amounting to $44,348.
The
Company has entered a consulting agreement with a biotech consultant. The
Agreement commenced on January 7, 2005 and has a six month term, which was
extended upon the agreement of both parties. The consultant provides three days
per month service during the term of the agreement with assistance on its
development efforts, reviewing the Company’s scientific technical and business
data and materials and introducing the Company to industry analysts,
institutional investor collaborators and strategic partners. As of October 1,
2007, the Company entered into a new two year agreement at a monthly fee of
$5,000 including 1,500,000 warrants exercisable at $0.20 per share as
consideration for his assistance in the equity raise on October 17, 2007 as well
his advisory services and assistance. This agreement is cancelable within 90
days notice.
The
Company has entered into a nonexclusive license and bailment agreement with the
Regents of UCLA to commercially develop products using the XFL7 strain of Listeria monoctyogenes in
humans and animals. The agreement is effective for a period of fifteen years and
is renewable by mutual consent of the parties. Advaxis is to pay UCLA an initial
license fee and annual maintenance fees for use of the Listeria. The Company may not
sell products using the XFL7 strain Listeria other than agreed
upon products or sublicense the rights granted under the license agreement
without the prior written consent of UCLA.
On
January 7, 2009 the Company entered into an Agreement with a business
development firm in a program to partner the Company’s vaccines. They do
licensing deals and are based in New Jersey. They have experience in
immunotherapies and similar to the Company’s vaccines. Their Agreement is for
$5,000 per month starting in January through April 2009 and $10,000 per month
from May 1 through February 2010 plus 5% of the deal, if completed in the first
24 months, 2 1/2% in the 12 months thereafter.
The
Company has entered into a GMP compliant filing of ADXS11-001 agreement with
German manufacturer to fill up to 5,000 vials of the Company’s clinical
supplies. This agreement was for €84,800 and is near completion in preparation
for the Company’s Phase II CIN trial.
The
Company has entered into a master service agreement with a firm in India on
September 20, 2006, a contract research organization for the purpose of
providing the Company with clinical trial management services in
the country of India in connection with the Company’s Phase I clinical
trial in ADXS11-001. Under the agreement, the Company will pay Apothecaries
amounts based on certain criteria detailed in the agreement such as clinical
sites qualified ($1,500 per site), submitting and obtaining regulatory approval
($17,000), and numbers of patients enrolled to the clinical trial ($7,500 for
each treated patient). If regulatory approval shall be obtained and 10 patients
shall be recruited and treated in 6 clinical sites, the Company shall pay
Apothecaries a total of $101,000. This project was placed on hold until the
Company’s next clinical trial.
The CEO
of the Company agreed to terms with the Company whereby he was named CEO
and Chairman effective December 15, 2006. He may also nominate one additional
Board Member of his choice subject to the By-Laws. Mr. Moore according to the
terms is to receive a salary annual salary of $250,000 to increase to $350,000,
subject to a successful sale by the Company of its securities for at lease
$4,000,000. He is also to receive 750,000 shares of the Company stock upon the
completion of sales or a sale of securities for gross proceeds of an additional
$4,000,000 to be issued based on the terms of his employment agreement and the
amount of the financial raise. He is eligible to receive an additional grant of
750,000 shares upon the raise of an additional $6,000,000. He will contribute up
to $500,000 personally to the raise. He received a grant of 2,400,000 options at
the price of $0.143 per share as of December 15, 2006 to vest monthly over 2
years. Mr. Moore is eligible to receive an additional grant of 1,500,000 shares
if the company stock is $0.40 per share or higher over 40 consecutive days. He
will receive a health care plan at no cost to him. In the event of a change of
control and his termination by the company, he will receive one-year severance
of $350,000.
The
Company entered into an employment agreement with Dr. Vafa Shahabi PhD to become
Head of Director of Science effective March 1, 2005, terminable on 30 days
notice. Her compensation is to be $115,000 per annum with a potential bonus of
$20,000.
The
Company entered into an employment agreement with Dr. John Rothman, PhD to
become Vice President of Clinical Development effective March 7, 2005 for a term
of one year ending February 28, 2006 and terminable on 30 days notice. His
compensation is currently $280,000 per annum, consisting of $250,000 in cash and
$30,000 in stock.
The
Company entered into an employment agreement with Fredrick D. Cobb to become
Vice President of Finance effective February 20, 2006 terminable on 30 days
notice. His compensation is currently $200,000 per annum, consisting of $180,000
in cash and $20,000 in stock. In fiscal year 2007, he was paid a $28,000
bonus.
The
Company is involved in various claims and legal actions arising in the ordinary
course of business. Management is of the opinion that the ultimate outcome of
these matters would not have a material adverse impact on the financial position
of the Company or the results of its operations.
9. INCOME
TAXES:
The
Company has a net operating loss carry forward of approximately $16,528,502 and
$9,340,529 at October 31, 2008 and 2007, respectively, available to offset
taxable income through 2028. Due to change in control provisions, the
Company’s utilization of these losses may be limited. The tax effects of loss
carry forwards give rise to a deferred tax asset and a related valuation
allowance at October 31, as follows:
|
|
|
2008
|
|
|
|
2007
|
|
Net
operating losses
|
|
$ |
6,611,401 |
|
|
|
3,736,212
|
|
Stock
based compensation
|
|
|
103,142 |
|
|
|
378,577
|
|
Less
valuation allowance
|
|
|
(6,714,543 |
) |
|
|
(4,114,729
|
) |
Deferred
tax asset
|
|
$ |
- |
|
|
|
-
|
|
The
difference between income taxes computed at the statutory federal rate of 34%
and the provision for income taxes relates to the following:
|
|
Year ended
October 31,
2006
|
|
|
Year ended
October 31,
2007
|
|
|
Period from
March 1, 2002
(inception) to
October 31,
2008
|
|
Provision
at federal statutory rate
|
|
|
34 |
% |
|
|
34 |
% |
|
|
34 |
% |
Valuation
allowance
|
|
|
(34 |
) |
|
|
(34 |
) |
|
|
(34 |
) |
|
|
|
- |
% |
|
|
- |
% |
|
|
- |
% |
The
Company adopted Financial Interpretation Number 48, “Accounting for Uncertain Tax
Positions” (“FIN 48”) on November 1, 2007. FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an enterprise’s
financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.”
FIN 48 prescribes a recognition threshold and measurement of a tax position
taken or expected to be taken in a tax return. The Company did not establish any
additional reserves for uncertain tax liabilities upon adoption of FIN 48. There
were no adjustments for uncertain tax positions in the current
year.
The
Company has not recognized any interest and penalties in the statement of
operations because its NOLs and tax credits are available to be carried
forward.
The
Company will account for interest and penalties related to uncertain tax
positions as part of its provision for federal and state income
taxes.
The
Company does not expect that the amounts of unrecognized benefits will change
significantly within the next 12 months.
The
Company is currently open to audit under the statute of limitations by the
Internal Revenue Service and state jurisdictions for various years from its
inception through 2007.
10. RECAPITALIZATION:
On
November 12, 2004, Great Expectations and Associates, Inc. (“Great
Expectations”) acquired the Company through a share exchange and reorganization
(the “Recapitalization”), pursuant to which the Company became a wholly owned
subsidiary of Great Expectations. Great Expectations acquired (i) all of the
issued and outstanding shares of common stock of the Company and the Series A
preferred stock of the Company in exchange for an aggregate of 15,597,723 shares
of authorized, but theretofore unissued, shares of common stock, no par value,
of Great Expectations; (ii) all of the issued and outstanding warrants to
purchase the Company’s common stock, in exchange for warrants to purchase
584,885 shares of Great Expectations; and (iii) all of the issued and
outstanding options to purchase the Company’s common stock in exchange for an
aggregate of 2,381,525 options to purchase common stock of Great Expectations,
constituting approximately 96% of the common stock of Great Expectations prior
to the issuance of shares of common stock of Great Expectations in the private
placement described below. Prior to the closing of the Recapitalization, Great
Expectations performed a 200-for-1 reverse stock split, thus reducing the issued
and outstanding shares of common stock of Great Expectations from 150,520,000
shares to 752,600 shares. Additionally, 752,600 shares of common stock of Great
Expectations were issued to the financial advisor in connection with the
Recapitalization. Pursuant to the Recapitalization, there were 17,102,923 common
shares outstanding in Great Expectations. As a result of the transaction, the
former shareholders of Advaxis are the controlling shareholders of the Company.
Additionally, prior to the transaction, Great Expectations had no substantial
assets. Accordingly, the transaction is treated as a recapitalization, rather
than a business combination. The historical financial statements of Advaxis are
now the historical financial statements of the Company. Historical shareholders’
equity (deficiency) of Advaxis has been restated to reflect the
recapitalization, and include the shares received in the
transaction.
On
November 12, 2004, the Company completed an initial closing of a private
placement offering (the “Private Placement”), whereby it sold an aggregate of
$2.925 million
worth of units to accredited investors. Each unit was sold for $25,000 (the
“Unit Price”) and consisted of (a) 87,108 shares of common stock and (b) a
warrant to purchase, at any time prior to the fifth anniversary following the
date of issuance of the warrant, to purchase 87,108 shares of common stock
included at a price equal to $0.40 per share of common stock (a “Unit”). In
consideration of the investment, the Company granted to each investor certain
registration rights and anti-dilution rights. Also, in November 2004, the
Company converted approximately $618,000 of aggregate principal promissory notes
and accrued interest outstanding into Units.
On
December 8, 2004, the Company completed a second closing of the Private
Placement, whereby it sold an aggregate of $200,000 of Units to accredited
investors.
On
January 4, 2005, the Company completed a third and final closing of the Private
Placement, whereby it sold an aggregate of $128,000 of Units to accredited
investors.
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by and
between the Company and Sunrise Securities, Corp. (the “Placement Agent”), the
Company issued to the Placement Agent and its designees an aggregate of
2,283,445 shares of common stock and warrants to purchase up to an aggregate of
2,666,900 shares of common stock. The shares were issued as part consideration
for the services of the Placement Agent, as placement agent for the Company in
the Private Placement. In addition, the Company paid the Placement Agent a total
cash fee of $50,530.
On
January 12, 2005, the Company completed a second private placement offering
whereby it sold an aggregate of $1,100,000 of units to a single investor. As
with the Private Placement, each unit issued and sold in this subsequent private
placement was sold at $25,000 per unit and is comprised of (i) 87,108 shares of
common stock, and (ii) a five-year warrant to purchase 87,108 shares of the
Company’s common stock at an exercise price of $0.40 per share. Upon the closing
of this second private placement offering the Company issued to the investor
3,832,753 shares of common stock and warrants to purchase up to an aggregate of
3,832,753 shares of common stock.
The
aggregate sale from the four private placements was $4,353,000, which was netted
against transaction costs of $329,673 for net proceeds of
$4,023,327.
Pursuant
to a Securities Purchase Agreement dated February 2, 2006 ($1,500,000 principal
amount) and March 8, 2006 ($1,500,000 principal amount) the Company issued to
Cornell Capital Partners, LP (“Cornell”) $3,000,000 principal amount of the
Company’s Secured Convertible Debentures due February 1, 2009 (the “Debentures”)
at face amount, and five year Warrants to purchase 4,200,000 shares of Common
Stock at the price of $0.287 per share and five year B Warrants to purchase
300,000 shares of Common Stock at a price of $0.3444 per share.
The
Debentures were convertible at a price equal to the lesser of (i) $0.287 per
share (“Fixed Conversion Price”), or (ii) 95% of the lowest volume weighted
average price of the Common Stock on the market on which the shares are listed
or traded during the 30 trading days immediately preceding the date of
conversion (“Market Conversion Price”). Interest was payable at maturity at the
rate of 6% per annum in cash or shares of Common Stock valued at the conversion
price then in effect.
Cornell
agreed that (i) it would not convert the Debenture or exercise the Warrants if
the effect of such conversion or exercise would result in its and its
affiliates’ holdings of more than 4.9% of the outstanding shares of Common
Stock, (ii) neither it nor its affiliates will maintain a short position or
effect short sales of the Common Stock while the Debentures are outstanding, and
(iii) no more than $300,000 principal amount of the Debenture could be converted
at the Market Conversion Price during a calendar month.
On August
24, 2007, the Company issued and sold an aggregate of $600,000 principal amount
promissory notes bearing interest at a rate of 12% per annum and warrants to
purchase an aggregate of 150,000 shares of its common stock to three investors
including Thomas A. Moore, the Company’s Chief Executive Officer. Mr. Moore
invested $400,000 and received warrants for the purchase of 100,000 shares of
Common Stock. The promissory note and accrued but unpaid interest thereon are
convertible at the option of the holder into shares of the Company’s common
stock upon the closing by the Company of a sale of its equity securities
aggregating $3,000,000 or more in gross proceeds to the Company at a conversion
rate which shall be the greater of a price at which such equity securities were
sold or the price per share of the last reported trade of the Company’s common
stock on the market on which the common stock is then listed, as quoted by
Bloomberg LP. At any time prior to conversion, the Company has the right to
prepay the promissory notes and accrued but unpaid interest thereon. Mr. Moore
converted his $400,000 bridge investment into 2,666,667 shares of common stock
and 2,000,000 $0.20 Warrants based on the terms of the Private Placement. He was
paid $7,101 interest in cash.
On
October 17, 2007, pursuant to a Securities Purchase Agreement, the Company
completed a private placement resulting in $7,384,235.10 in gross proceeds,
pursuant to which it sold 49,228,334 shares of common stock at a purchase price
of $0.15 per share solely to institutional and accredited investors. Each
investor received a five-year warrant to purchase an amount of shares of common
stock that equals 75% of the number of shares of common stock purchased by such
investor in the offering.
Concurrent
with the closing of the private placement, the Company sold for $1,996,700 to
CAMOFI Master LDC and CAMHZN Master LDC, affiliates of its financial advisor,
Centrecourt Asset Management (“Centrecourt”), an aggregate of
(i) 10,000,000 shares of Common Stock, (ii) 10,000,000 warrants
exercisable at $0.20 per share, and (iii) 5-year warrants to purchase an
additional 3,333,333 shares of Common Stock at a purchase price of $0.001 per
share (the “$0.001 Warrants”). The Company and the two purchasers agreed that
the purchasers would be bound by and entitled to the benefits of the Securities
Purchase Agreement as if they had been signatories thereto. The $0.20 Warrants
and $0.001 Warrants contain the same terms, except for the exercise price. Both
warrants provide that they may not be exercised if, following the exercise, the
holder will be deemed to be the beneficial owner of more than 9.99% of the
Company’s outstanding shares of Common Stock. Pursuant to a consulting agreement
dated August 1, 2007 with Centrecourt with respect to the anticipated financing,
in which Centrecourt was engaged to act as the Company’s financial advisor, the
Company paid Centrecourt $328,000 in cash and issued 2,483,333 warrants
exercisable at $0.20 per share to Centrecourt, which Centrecourt assigned to the
two affiliates.
All of
the $0.20 Warrants and $0.001 Warrants provide for adjustment of their exercise
prices upon the occurrence of certain events, such as payment of a stock
dividend, a stock split, a reverse split, a reclassification of shares, or any
subsequent equity sale, rights offering, pro rata distribution, or any
fundamental transaction such as a merger, sale of all of its assets, tender
offer or exchange offer, or reclassification of its common stock. If at any time
after October 17, 2008 there is no effective registration statement registering,
or no current prospectus available for, the resale of the shares underlying the
warrants by the holder of such warrants, then the warrants may also be exercised
at such time by means of a “cashless exercise.”
In
connection with the private placement, the Company entered into a registration
rights agreement with the purchasers of the securities pursuant to which the
Company agreed to file a registration statement with the Securities and Exchange
Commission with an effectiveness date within 90 days after the final closing of
the offering. The resale of 49,228,334 shares of common stock and 36,921,250
shares underlying the warrants is being registered in its prospectus. The
registration statement was declared effective on January 22, 2008. See Item 1
“Description of Business - Recent Developments.”
At the
closing of this private placement, the Company exercised its right under an
agreement dated August 23, 2007 with Yorkville, to redeem the outstanding
$1,700,000 principal amount of its Secured Convertible Debentures due February
1, 2009 owned by Yorkville, and to acquire from Yorkville warrants expiring
February 1, 2011 to purchase an aggregate of 4,500,000 shares of its common
stock. The Company paid an aggregate of (i) $2,289,999 to redeem the
debentures at the principal amount plus a 20% premium and accrued and unpaid
interest, and (ii) $600,000 to repurchase the warrants.
On
September 22, 2008, the Company entered into a Note Purchase Agreement (the
“Agreement”) with the Company’s Chief Executive Officer, Mr. Moore, pursuant to
which the Company agreed to sell to Mr. Moore, from time to time, one or more
senior promissory notes (each a “Note” and collectively the “Notes”) with an
aggregate principal amount of up to $800,000.
The
Agreement was reviewed and recommended to the Company’s Board of Directors (the
“Board”) by a special committee of the Board and was approved by a majority of
the disinterested members of the Board. The Note or Notes, if and when issued,
will bear interest at a rate of 12% per annum, compounded quarterly, and will be
due and payable on the earlier of the close of the Company’s next equity
financing resulting in gross proceeds to the Company of at least $5,000,000 (the
“Subsequent Equity Raise”) or February 15, 2009 (the “Maturity Date”). The
Note(s) may be prepaid in whole or in part at the option of the Company without
penalty or any time prior to the Maturity Date.
In
consideration of Mr. Moore’s agreement to purchase the Notes, the Company agreed
that concurrently with the Subsequent Equity Raise, the Company will issue to
Mr. Moore a warrant to purchase the Company’s common stock, which will entitle
Mr. Moore to purchase a number of shares of the Company’s common stock equal to
one share per $1.00 invested by Mr. Moore in the purchase of one or more Notes.
Such warrant would contain the same terms and conditions as warrants issued to
investors in the Subsequent Equity Raise.
As of
October 31, 2008 and pursuant to the Agreement, Mr. Moore has loaned the Company
$475,000. Mr. Moore informed the Company that based on the funds generated by
the NOL received on December 12, 2008 (see Note 11) and personal considerations
that he may not make full funding. On December 15, 2008
the Board approved an amendment of the Agreements repayment terms from February
15, 2009 to June 15, 2009. In consideration for revising the repayment term the
Company repaid Mr. Moore $50,000 from the $475,000 outstanding Notes thus
reducing the balance to $425,000.
11. SUBSEQUENT
EVENT:
In a
letter dated November 13, 2008 from the NJEDA, the Company was notified that its
application for the New Jersey Technology Tax Certificate Transfer Program was
preliminarily approved. Under the State of New Jersey Program for
small businesses, the Company received a net cash amount of $922,020 on December
12, 2008 from the sale of its State NOLs through December 31, 2007 of
$1,084,729.
ADVAXIS,
INC.
(A
Development Stage Company)
Balance
Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
|
|
$ |
49,126 |
|
|
$ |
59,738 |
|
Prepaid
expenses
|
|
|
40,105 |
|
|
|
38,862 |
|
Total
Current Assets
|
|
|
89,231 |
|
|
|
98,600 |
|
|
|
|
|
|
|
|
|
|
Deferred
expenses
|
|
|
366,938 |
|
|
|
– |
|
Property
and Equipment, net
|
|
|
63,661 |
|
|
|
91,147 |
|
Intangible
Assets, net
|
|
|
1,310,078 |
|
|
|
1,137,397 |
|
Other
Assets
|
|
|
3,876 |
|
|
|
3,876 |
|
Total
Assets
|
|
$ |
1,833,784 |
|
|
$ |
1,331,020 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,362,832 |
|
|
$ |
998,856 |
|
Accrued
expenses
|
|
|
965,886 |
|
|
|
603,345 |
|
Convertible
Bridge Notes and fair value of embedded derivative
|
|
|
796,154 |
|
|
|
– |
|
Notes
payable - current portion including interest payable
|
|
|
1,094,450 |
|
|
|
563,317 |
|
Total
Current Liabilities
|
|
|
4,219,322 |
|
|
|
2,165,518 |
|
|
|
|
|
|
|
|
|
|
Common
Stock Warrants
|
|
|
11,253,594 |
|
|
|
– |
|
Notes
payable - net of current portion
|
|
|
- |
|
|
|
4,813 |
|
Total
Liabilities
|
|
$ |
15,472,916 |
|
|
$ |
2,170,331 |
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
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 as of July 31, 2009; and 109,319,520 as of October
31, 2008
|
|
|
115,637 |
|
|
|
109,319 |
|
Additional
Paid-In Capital
|
|
|
4,217,074 |
|
|
|
16,584,414 |
|
Deficit
accumulated during the development stage
|
|
|
(17,971,843 |
) |
|
|
(17,533,044 |
) |
Total
Shareholders’ Deficiency
|
|
$ |
(13,639,132 |
) |
|
$ |
(839,311 |
) |
Total
Liabilities & Shareholders’ Deficiency
|
|
$ |
1,833,784 |
|
|
$ |
1,331,020 |
|
The
accompanying notes are an integral part of these financial
statements.
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Operations
(Unaudited)
|
|
9 Months
Ended
July 31,
2009
|
|
|
9 Months
Ended
July 31,
2008
|
|
|
Period from
March 1,
2002
(Inception)
to July 31,
2009
|
|
Revenue
|
|
$ |
(5,369 |
) |
|
$ |
68,404 |
|
|
$ |
1,319,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& Development Expenses
|
|
|
939,407 |
|
|
|
2,004,324 |
|
|
|
8,797,391 |
|
General
& Administrative Expenses
|
|
|
2,019,648 |
|
|
|
2,349,439 |
|
|
|
12,028,215 |
|
Total
Operating expenses
|
|
|
2,959,055 |
|
|
|
4,353,763 |
|
|
|
20,825,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from Operations
|
|
|
(2,964,424 |
) |
|
|
(4,285,359 |
) |
|
|
(19,505,803 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(410,615 |
) |
|
|
(5,705 |
) |
|
|
(1,495,098 |
) |
Other
Income
|
|
|
|
|
|
|
46,427 |
|
|
|
246,457 |
|
Gain
on note retirement
|
|
|
– |
|
|
|
– |
|
|
|
1,532,477 |
|
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
|
|
2,014,220 |
|
|
|
– |
|
|
|
371,988 |
|
Net
income (loss) before benefit for income tax benefit
|
|
|
(1,360,819 |
) |
|
|
(4,244,637 |
) |
|
|
(18,849,979 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax benefit
|
|
|
922,020 |
|
|
|
– |
|
|
|
922,020 |
|
Net
income (loss)
|
|
|
(438,799 |
) |
|
|
(4,244,637 |
) |
|
|
(17,927,959 |
) |
Dividends
attributable to preferred shares
|
|
|
– |
|
|
|
– |
|
|
|
43,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) applicable to common Stock
|
|
$ |
(438,799 |
) |
|
$ |
(4,244,637 |
) |
|
$ |
(17,971,843 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share, basic
|
|
$ |
0.00 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share, diluted
|
|
$ |
0.00 |
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares outstanding, basic
|
|
|
112,599,706 |
|
|
|
108,513,191 |
|
|
|
|
|
Weighted
average number of shares outstanding, diluted
|
|
|
112,599,706 |
|
|
|
108,513,191 |
|
|
|
|
|
The
accompanying notes are an integral part of these financial
statements.
ADVAXIS,
INC.
(A
Development Stage Company)
Statement
of Cash Flows
(Unaudited)
|
|
9
Months
ended
July 31,
2009
|
|
|
9
Months
ended
July 31,
2008
|
|
|
Period
from
March
1, 2002
(Inception)
to
July
31, 2009
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(438,799 |
) |
|
$ |
(4,244,637 |
) |
|
$ |
(17,927,959 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
charges to consultants and employees for options and stock
|
|
|
372,695 |
|
|
|
311,806 |
|
|
|
2,225,925 |
|
Amortization
of deferred financing costs
|
|
|
– |
|
|
|
– |
|
|
|
260,000 |
|
Amortization
of Discount on bridge Loan
|
|
|
37,231 |
|
|
|
– |
|
|
|
37,321 |
|
Non-cash
interest expense
|
|
|
345,044 |
|
|
|
3,002 |
|
|
|
863,229 |
|
Change
in value of warrants and embedded derivative
|
|
|
(2,014,218 |
) |
|
|
– |
|
|
|
(371,988 |
) |
Value
of penalty shares issued
|
|
|
– |
|
|
|
31,778 |
|
|
|
149,276 |
|
Depreciation
expense
|
|
|
27,486 |
|
|
|
26,975 |
|
|
|
119,576 |
|
Amortization
expense of intangibles
|
|
|
54,374 |
|
|
|
51,795 |
|
|
|
367,885 |
|
Gain
on note retirement
|
|
|
– |
|
|
|
– |
|
|
|
(1,532,477 |
) |
(Increase)
Decrease in prepaid expenses
|
|
|
(1,243 |
) |
|
|
94,711 |
|
|
|
(40,105 |
) |
Increase
in other assets
|
|
|
– |
|
|
|
– |
|
|
|
(3,876 |
) |
Increase
in Deferred expenses
|
|
|
(116,938 |
) |
|
|
– |
|
|
|
(116,938 |
) |
Increase
in accounts payable
|
|
|
415,954 |
|
|
|
113,162 |
|
|
|
1,852,016 |
|
Increase
in accrued expenses
|
|
|
112,541 |
|
|
|
101,781 |
|
|
|
699,699 |
|
Accrued
interest on notes payable
|
|
|
– |
|
|
|
– |
|
|
|
18,291 |
|
Increase
in deferred revenue
|
|
|
– |
|
|
|
6,596 |
|
|
|
– |
|
Net
cash used in Operating Activities
|
|
|
(1,205,873 |
) |
|
|
(3,503,031 |
) |
|
|
(13,400,123 |
) |
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid on acquisition of Great Expectations
|
|
|
– |
|
|
|
– |
|
|
|
(44,940 |
) |
Purchase
of property and equipment
|
|
|
– |
|
|
|
(10,842 |
) |
|
|
(137,657 |
) |
Cost
of intangible assets
|
|
|
(227,054 |
) |
|
|
(178,542 |
) |
|
|
(1,752,914 |
) |
Net
cash used in Investing Activities
|
|
|
(227,054 |
) |
|
|
(189,384 |
) |
|
|
(1,935,511 |
) |
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from convertible secured debenture
|
|
|
– |
|
|
|
– |
|
|
|
960,000 |
|
Cash
paid for deferred financing costs
|
|
|
|
|
|
|
|
|
|
|
(260,000 |
) |
Principal
payment on notes payable
|
|
|
(12,320 |
) |
|
|
(10,960 |
) |
|
|
(119,239 |
) |
Proceeds
from notes payable
|
|
|
– |
|
|
|
– |
|
|
|
1,271,224 |
|
Proceeds
from notes payable
|
|
|
1,434,635 |
|
|
|
– |
|
|
|
1,909,635 |
|
Net
proceeds of issuance of Preferred Stock
|
|
|
– |
|
|
|
– |
|
|
|
235,000 |
|
Payment
on cancellation of warrants
|
|
|
– |
|
|
|
– |
|
|
|
(600,000 |
) |
Proceeds
of issuance of Common Stock; net of issuance costs
|
|
|
– |
|
|
|
(78,013 |
) |
|
|
11,988,230 |
|
Net
cash provided by (used in) Financing Activities
|
|
$ |
1,422,315 |
|
|
$ |
(88,973 |
) |
|
$ |
15,384,850 |
|
Net
(Decrease) Increase in cash
|
|
|
(10,612 |
) |
|
|
(3,781,388 |
) |
|
|
49,216 |
|
Cash
at beginning of period
|
|
|
59,738 |
|
|
|
4,041,984 |
|
|
|
– |
|
Cash
at end of period
|
|
$ |
49,126 |
|
|
$ |
260,596 |
|
|
$ |
49,216 |
|
The
accompanying notes are an integral part of these financial
statements.
ADVAXIS,
INC.
(A
Development Stage Company)
(Unaudited) Supplemental
Schedule of Noncash Investing and Financing Activities
|
|
9
Months
ended
July 31,
2009
|
|
|
9
Months
ended
July 31,
2008
|
|
|
Period
from
March
1, 2002
(Inception)
to
July
31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
Equipment
acquired under capital lease
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
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 |
|
D
Debt discount in connection with recording the original value of the
embedded derivative liability
|
|
$ |
1,023,116 |
|
|
$ |
– |
|
|
$ |
1,535,912 |
|
Allocation
of the original secured convertible debentures to warrants
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
214,950 |
|
Allocation
of the Warrant on Bridge Loan as debt discount
|
|
$ |
250,392 |
|
|
|
|
|
|
$ |
250,392 |
|
Warrants
issued in connection with issuances of common stock
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
1,505,550 |
|
Warrants
recorded as a liability
|
|
$ |
12,785,695 |
|
|
$ |
– |
|
|
$ |
12,785,695 |
|
The
accompanying notes are an integral part of these financial
statements.
ADVAXIS,
INC.
(a
development stage company)
NOTES
TO FINANCIAL STATEMENTS (Unaudited)
1. NATURE
OF OPERATIONS AND LIQUIDITY
Advaxis,
Inc., (the “Company”) is a development stage biotechnology company with the
intent to develop safe and effective cancer vaccines that utilize multiple
mechanisms of immunity. We are developing a live Listeria vaccine technology
under license from the University of Pennsylvania (“Penn”) which secretes a
protein sequence containing a tumor-specific antigen. We believe this vaccine
technology is capable of stimulating the body’s immune system to process and
recognize the antigen as if it were foreign, generating an immune response able
to attack the cancer. We believe that 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.
Since our
inception in 2002 we have focused our research and development efforts upon
understanding our technology and establishing a product development pipeline
that incorporates this technology in the therapeutic cancer vaccines area
targeting cervical, prostate, breast and CIN, a pre cancerous indication.
Although no products have been commercialized to date, research and development
and investment continues to be placed behind the pipeline and the advancement of
this technology. Pipeline development and the further exploration of the
technology for advancement entail risk and expense. It is anticipated that
ongoing operational costs for the development stage company will increase
significantly as we expect to begin several clinical trials starting this fiscal
year.
As of
July 31, 2009, we had $49,126 in cash, a deficit of $4,130,091 in working
capital, $ 2,252,803 of principal and interest payable on our notes payable,
stockholders deficiency of $ 13,639,132 and an accumulated deficiency of
$17,971,843.
In a
letter dated November 13, 2008 from the New Jersey Economic Development
Authority we were notified that our application for the New Jersey Technology
Tax Certificate Transfer Program was preliminarily approved. Under the State of
New Jersey Program for small business we received a net cash amount of $922,020
on December 12, 2008 from the sale of our State Net Operating Losses (“NOL”)
through December 31, 2007 of $1,084,729.
Our net
loss for the nine months ended July 31, 2009 was $438,799 which includes
$922,020 of tax benefit received in this period from the New Jersey Technology
Tax Certificate Transfer Program and $2,014,220 for the net change in fair value
of common stock warrant and embedded derivative liabilities
Since our
inception until July 31, 2009, the Company has reported accumulated net losses
of $17,927,959 and recurring negative cash flows from operations. In order to
maintain sufficient cash and investments to fund future operations, we are
seeking to raise additional capital and reduce expenses over the August through
September 2009 time period through various financing alternatives. During the
fiscal year ended October 31, 2008 the Company received $475,000 from Notes
provided by our CEO, Thomas Moore (the “Moore Notes”). Although the
Company repaid Mr. Moore $50,000 in the three months ended January 31, 2009, as
of July 31, 2009 he has loaned an additional $522,985 for a total of
$947,985. In addition, the Company sold its Net operating loss
(“NOL”) to the New Jersey Economic Development Administration (”NJEDA”) for
$922,020 and has reduced the salaries of all its highly compensated employees
effective as of January 4, 2009. On June 18, 2009 we also entered
into a Note Purchase Agreement for $1,131,353 in senior secured bridge notes
issued at a 15% discount and received proceeds of $961,650 (the “Bridge
Notes”).
Since
inception through July 31, 2009, principally all of the Company’s revenue has
been from grants.
2. Basis
of Presentation
The
accompanying unaudited interim consolidated financial statements include all
adjustments (consisting only of those of a normal recurring nature) necessary
for a fair statement of the results of the interim period. These interim
Financial Statements should be read in conjunction with the Company’s Financial
Statements and Notes for the year ended October 31, 2008 filed on Form 10-KSB.
We believe these financial statements reflect all adjustments (consisting only
of normal, recurring adjustments) that are necessary for a fair presentation of
our financial position and results of operations for the periods presented.
Results of operations for the interim periods presented are not necessarily
indicative of results to be expected for the year.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. There is a working capital deficiency and
recurring losses that raise substantial doubt about its ability to continue as a
going concern. The financial statements do not include any adjustments to the
carrying amount and classification of recorded assets and liabilities should we
be unable to continue operations.
Management’s intends
to seek additional funding to assure the Company’s viability, through
private or public equity offering, and/or debt financing. There can be
no assurance that management will be successful in any of those
efforts.
Since
October 31, 2008 our short term financing plans through July 2009 consisted of
the Moore Notes the sale of the NOL provided by the NJEDA, the reduction in
salaries of all our highly compensated employees effective as of January 4, 2009
and the 2009 Bridge Notes. We plan on raising an additional $1,000,000 through
additional debt financing. We anticipate that this will be sufficient to finance
our currently planned operations to October 2009.
The
preparation of financial statements in conformity with generally accepted
accounting principles required management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosures of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates and the differences could be
material. The most significant estimates impact the following transactions or
account balances: stock compensation, liabilities, warrant & options
valuations, impairment of intangibles and fixed assets.
Recently
Issued Accounting Pronouncements
In June
2008, The FASB ratified Emerging Issues Task Force (EITF) Issue No 07-5,
“Determining Whether an Instrument (or Embedded Feature) is Indexed to an
Entity’s Own Stock” (EITF 07-5). EITF 07-5 mandates a two-step process for
evaluating whether an equity-linked financial instrument or embedded feature
indexed to the entities own stock. It is effective for fiscal years beginning
after December 15, 2008, and interim periods within those fiscal years, which is
our first quarter of fiscal 2010. Many of the warrants issued by the Company
contain a strike price adjustment feature, which upon adoption of EITF 07-5, may
result in the instruments no longer being considered indexed to the Company’s
own stock. Accordingly, adoption of EITF 07-5 may change the current
classification (from equity to liability) and the related accounting for many
warrants outstanding at that date. Even though the Company now
records warrants and the embedded derivative as a liability under the guidance
contained in EITF 00-19 “ Accounting for Derivative Financial Instrument Indexed
to and Potentially Settled In, a Company’s Own Common Stock,” and SFAS 133
“Accounting for Derivative Instruments and Hedging Activities. In accordance
with the guidance provided in EITF 05-2 in order to clarify provisions of EITF
00-19, the Company determined that the conversion feature in the Bridge Notes
represented an embedded derivative since the debenture is convertible into a
variable number of shares based upon a conversion formula which could require
the Company to issue shares in excess of its authorized amount. The convertible
debentures are not considered “conventional” convertible debt under EITF 00-19
and the embedded conversion feature was bifurcated from the debt host and
accounted for as a derivative liability. The Company is currently evaluating the
impact the adoption of EITF 07-5 may have on its financial position, results of
operation, or cash flows.
In
May 2009, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 165, Subsequent Events (“SFAS
165”), which provides guidance to establish general standards of accounting for
and disclosures of events that occur after the balance sheet date but before
financial statements are issued or are available to be issued. SFAS 165 also
requires entities to disclose the date through which subsequent events were
evaluated as well as the rational as to why the date was selected. SFAS 165 is
effective for interim and annual periods ended after June 15, 2009. The
Company has adopted the provisions of SFAS 165. The Company has evaluated
subsequent events through the date of issuance of the July 31,
2009 financial statements, September 23, 2009 and updated its review
through November 6, 2009.
In
July 2009, the FASB issued SFAS No. 168, FASB Accounting Standards
Codification ™ and the Hierarchy of Generally Accepted Accounting Principles — a
replacement of FASB Statement No. 162 (“SFAS 168”). With the issuance of
SFAS 168, the FASB Standards Codification (“Codification”) becomes the single
source of authoritative U.S. accounting and reporting standards applicable for
all non-governmental entities, with the exception of guidance issued by the
Securities and Exchange Commission. The Codification does not change current
U.S. GAAP, but changes the referencing of financial standards and is intended to
simplify user access to authoritative U.S. GAAP, by providing all the
authoritative literature related to a particular topic in one place. The
Codification is effective for interim and annual periods ended after
September 15, 2009. At that time, all references made to U.S. GAAP will use
the new Codification numbering system prescribed by the FASB. The adoption of
SFAS No. 168 will result in the change of disclosures to reflect the new
codification references, but otherwise the Company does not expect it to have
any effect on its financial statements.
Management
does not believe that any other recently issued, but not yet effective,
accounting standards if currently adopted would have a material effect on the
accompanying financial statements.
3. Intangible
Assets
Intangible
assets primarily consist of legal and filing costs associated with obtaining
patents and licenses. The license and patent costs capitalized primarily
represent the value assigned to the Company’s 20-year exclusive worldwide
license agreement with Penn which are amortized on a straight-line basis over
their remaining useful lives which are estimated to be twenty years from the
effective date of the Penn Agreement dated July 1, 2002. The value of the
license and patents is based on management’s assessment regarding the ultimate
recoverability of the amounts paid and the potential for alternative future
uses. This license now includes the exclusive right to strategically exploit 17
patents issued and 18 pending filed in some of the largest markets in the world
(excluding the patents issued and applied for that we are no longer pursing in
smaller markets). After careful review and analysis we decided not to
pursue 4 patents issued and 6 patent applications filed in smaller
countries.
This
license agreement has been amended, from time to time, and was amended and
restated on February 13, 2007. We have acquired and paid for the First
Amended and Restated Patent License Agreement. However, the Second
Amendment that we have been negotiating with Penn, to exercise our option to
license an additional 12 other dockets or approximately 22 or more
additional patent applications for Listeria and LLO-based
vaccine dockets was not finalized. In order to enter into this Second
Amendment as of July 31, 2009 we are contingently liable for $447,108
including the reimbursement of certain legal and filing costs. We
are still in negotiations with Penn over the form of payment, some
combination of stock or cash, and expect to reach a conclusion at the close of
our next financial raise. These fees are currently unpaid and are not
recorded in our financial statements as of the July 31, 2009. While
we consider our relationship with Penn good we are in frequent communications
over payment of past due invoices and other payables due to our lack of cash. If
we fail to reach a mutual agreement, Penn may issue a default notice and we will
have 60 days to cure the breach or be subject to the termination of the
agreement.
As of
July 31, 2009, all gross capitalized costs associated with the licenses and
patents filed and granted as well as costs associated with patents pending are
$1,569,880 as shown under license and patents on the table below, excluding the
Second Amendment costs. Out of the $1,569,880 capitalized cost the
cost of the patents and licenses issued is estimated to be $797,942 and cost of
the patents pending or in the process of filing is estimated to be $771,938. The
expirations of the existing patents range from 2014 to 2020 but the expirations
may be extended based on market approval if granted and/or based on existing
laws and regulations. Capitalized costs associated with patent applications that
are abandoned without future value or patents applications that are not issued
are charged to expense when the determination is made not to pursue the
application. Based on a review and analysis of its patents we determined that it
was no longer cost effective to pursue patents in other countries such as
Canada, Israel or Ireland. A review of the capitalized costs for
these countries resulted in the write-off of $26,087 as of July 31, 2009 of
capitalized cost since inception of the company and the elimination of a total
of ten patent and patent applications. No other additional patent
applications with future value were abandoned and charged to expense in the
current or prior year. Amortization expense for licensed technology and
capitalized patent cost is included in general and administrative
expenses.
Under the
amended and restated agreement we are billed actual patent expenses as they are
passed through from Penn and or billed directly from our patent attorney. The
following is a summary of the intangibles assets as of the following fiscal
periods:
|
|
|
|
|
|
|
|
|
|
License
|
|
$ |
571,275 |
|
|
$ |
529,915 |
|
|
$ |
41,360 |
|
Patents
|
|
|
998,605 |
|
|
|
812,910 |
|
|
|
185,695 |
|
Total
intangibles
|
|
|
1,569,880 |
|
|
|
1,342,825 |
|
|
|
227,055 |
|
Accumulated
Amortization
|
|
|
(259,802 |
) |
|
|
(205,428 |
) |
|
|
(54,374 |
) |
Intangible
Assets
|
|
$ |
1,310,078 |
|
|
$ |
1,137,397 |
|
|
$ |
172,681 |
|
The
Company reviews long-lived assets for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. An asset is considered to be impaired when the sum of the
undiscounted future net cash flows expected to result from the use of the asset
and its eventual disposition exceeds its carrying amount. The amount of
impairment loss, if any, is measured as the difference between the net book
value of the asset and its estimated fair value.
4. Net
Income (Loss) Per Share
In
accordance with the provisions of the Statement of Financial Accounting
Standards (“SFAS”) No. 128, “Earning per Share,” basic net income or basic net
loss per common share is computed by dividing net income available to common
shareholders by the weighted average number of common shares outstanding during
the periods. Diluted earnings per share give effect to dilutive options,
warrants, convertible debt and other potential common stock outstanding
during the period. Therefore, in the case of a net loss, the impact of the
potential common stock resulting anti-dilutive provisions in the investment
agreements that effect common stock, warrants, outstanding stock options and
convertible debt are not included in the computation of diluted loss per
share, as the effect would be anti-dilutive. In the case of net income the
impact of the potential common stock change resulting from these instruments
that have intrinsic value are included in the diluted earnings per share. The
table sets forth the number of potential shares of common stock that have been
excluded from diluted net loss per share. The warrants and certain common stock
include anti-dilutive provisions to adjust the number common stock and warrants
as well as the price of the warrants based on certain types of equity
transactions.
|
|
|
|
|
|
|
Warrants
|
|
|
89,143,801 |
|
|
|
94,149,587 |
|
Stock
Options
|
|
|
17,962,841 |
|
|
|
8,812,841 |
|
Total
All
|
|
|
107,106,642 |
|
|
|
102,962,428 |
|
5. Notes
Payable
On
September 22, 2008, Advaxis entered into an agreement (the “Moore Agreement”)
with the Company’s Chief Executive Officer, Thomas Moore, pursuant to which the
Company agreed to sell to Mr. Moore, from time to time, the Moore Notes. On June
15, 2009, Mr. Moore and the Company amended the Moore Notes to increase the
amounts available pursuant to the Moore Agreement from $800,000 to $950,000 and
change the maturity date of the Moore Notes from June 15, 2009 to the earlier of
January 1, 2010 (the “Maturity Date”) or the Company’s next equity financing
resulting in gross proceeds to the Company of at least $6 million (“Subsequent
Equity Raise”). The balance of the Moore Agreement is $947,985 as of July 31,
2009. The Moore Agreement was amended per the terms of the June 18, 2009 Note
Purchase Agreement (described below) retroactively to include the same warrant
provision provided to Investors in the Note Purchase Agreement.
Effective
June 18, 2009 we entered into a Note Purchase Agreement with each of accredited
and/or sophisticated investors, pursuant to which it completed a private
placement whereby the Investors acquired senior convertible promissory notes of
the Company in the aggregate principal face amount of $1,131,353, for an
aggregate net purchase price of $961,650. The Bridge Notes were
issued with an original issue discount of 15%. Each Investor paid
$0.85 for each $1.00 of principal amount of notes purchased at the
closing. The Bridge Notes are convertible into shares of the
Company’s common stock at an exercise price contingent on the completion of
equity financing as described below. For every dollar invested, each
Investor received warrants to purchase 2 ½ shares of common stock (the “Bridge
Warrants”) at an exercise price of $0.20 per share, subject to adjustments upon
the occurrence of certain events as more particularly described below and in the
form of Warrant. The Bridge Notes are to mature on December 31, 2009 if not
retired sooner. They may be prepaid in whole or in part at the option of the
Company without penalty at any time prior to the Maturity Date. The warrants may
be exercised on a cashless basis under certain circumstances.
In the
event the Company consummates an equity financing after August 1, 2009 and prior
to the second business day immediately preceding the Maturity Date, in which it
sells shares of its stock with aggregate gross proceeds of not less than
$2,000,000, then prior to the Maturity Date, the Investors shall have the option
to convert all or a portion of the Bridge Notes into the same securities sold in
the Qualified Equity Financing (“QEF”), at an effective per share conversion
price equal to 90% of the per share purchase price of the securities
issued in the QEF. In the event the Company does not consummate a QEF
from and after August 1, 2009 and prior to the second business day immediately
preceding the Maturity Date, then the Investors shall have the option to convert
all or a portion of the Bridge Notes into shares of common stock, at an
effective per share conversion price equal to 50% of the volume-weighted average
price (“VWAP”) per share of the common stock over the five (5) consecutive
trading days immediately preceding the third business day prior to the Maturity
Date. To the extent an Investor does not elect to convert its Bridge Note as
described above, the principal amount of the Bridge Note not so converted shall
be payable in cash on the Maturity Date.
In
connection with the bridge transaction, the Company entered into a Security
Agreement, dated as of June 18, 2009 with the Investors. The Security
Agreement grants the Investors a security interest in all of the Company’s
tangible and intangible assets, as further described in the Security Agreement.
The Company also entered into a Subordination Agreement, dated as of June 18,
2009 (the “Subordination Agreement”) with the Investors and Mr.
Moore. Pursuant to the Subordination Agreement, Mr. Moore
subordinated certain rights to payments under the Moore Notes to the right of
payment in full in cash of all amounts owed to the Investors pursuant to the
Notes; provided, however, that principal and interest of the Moore Notes may be
repaid prior to the full payment of the Investors under certain
circumstances.
The
Company issued a note for $10,000 dated November 13, 2003 and a note for $40,000
dated December 17, 2003 to BioAdvance Biotechnology Greenhouse of Southeastern
Pennsylvania Notes (“BioAdvance”) that were each due on their fifth anniversary
date thereof. On February 5, 2009, BioAdvance issued the Company a letter
demanding the payment of the loans and interest payable of $70,605. The
outstanding balance of these notes as of July 31, 2009 is $72,612. The Company
has agreed to make full payment on October 31, 2009. The terms of both notes
call for accrual of 8% interest per annum on the unpaid
principal.
6.
|
Derivative
Instruments
|
As of
July 31, 2009, there were outstanding warrants to purchase 89,143,801 shares of
our common stock (adjusted for anti-dilution provision to-date) with exercise
prices ranges from $0.183 to $0.287 per share (adjusted for anti-dilution
provisions to-date). These warrants include 2,404,125 warrants issued
to Bridge Notes holders at an exercise price of $0.20 per warrant. Most of the
warrants include anti-dilutive provisions that can trigger an adjustment to the
number and price of the warrants outstanding resulting from certain future
equity transactions issued below their exercise price.
The
warrants to purchase shares of common stock issued by the Company in connection
with our private placements consummated on October 17, 2007 (the “2007
Warrants”) contain “full-ratchet” anti-dilution provisions set at $0.20 with a
term of five years. Therefore, any future financial offering or
instrument issuance below $0.20 per share of the company’s common stock or
warrants will trigger the full-ratchet anti-dilution provisions in approximately
54,653,917 of the outstanding 2007 Warrants lowering the exercise price of such
2007 Warrants from $0.20 to an offering price and proportionately increasing the
number of shares that could be obtained upon the exercise of such
warrants. Additionally, the Company has 30,928,581 warrants
outstanding (the “Prior Warrants”) which a vast majority contain weighted
average anti-dilution provisions. As a result, an offering or
instrument issuance below $0.26 per share will trigger the weighted average
anti-dilution provisions in such outstanding Prior Warrants, substantially
lowering the exercise price of such Prior Warrants (in accordance with the terms
of the Prior Warrants) and proportionately increasing the number of shares that
could be obtained upon the exercise of such Prior Warrants. A
majority of these Prior Warrants expire on November 12, 2009 and most of the
balance will expire on or about December 31, 2009. There are also 3,561,303
warrants not included in the warrants above that are outstanding; 944,438 that
don’t include any anti-dilution provision and 2,616,865 that have some form of
anti-dilution provision.
In May
2009 all of the 3,333,333 warrants that were purchased for $0.149 per warrant
with an exercise price of $0.001 were exercised on a cashless basis and
3,299,999 common shares were issued.
The Bridge
Note entered into June 18, 2009 whereby the Investors acquired senior
convertible promissory notes of the Company in the aggregate principal face
amount of $1,131,353, for an aggregate net purchase price of $961,650. The
Bridge Notes were issued with an OID of 15%. Each Investor paid $0.85 for each
$1.00 of principal amount of notes purchased at the Bridge closing. The Bridge
Notes are convertible into shares of the Company’s common stock, as previously
described in the note 5 Notes Payable. For every dollar invested they
received warrants to purchase 2 ½ shares of common stock warrants at an exercise
price of $0.20 per share, subject to adjustment upon the occurrence of certain
events detailed below. The Bridge Notes are to mature on December 31, 2009 if
not retired sooner. The warrants may be exercised on a cashless basis
under certain circumstances.
In the
event the Company consummates an equity financing after August 1, 2009 and prior
to the second business say immediately preceding the Maturity Date, in which it
sells shares of its stock with aggregate gross proceeds of not less than
$2,000,000, then prior to the Maturity Date, the Investors shall have the option
to convert all or a portion of the New Notes into the same securities sold in
the QEF, at an effective per share conversion price equal to 90% of the per
share purchase price of the securities issued in the QEF. In
the event the Company does not consummate a QEF from and after August 1, 2009
and prior to the second business day immediately preceding the Maturity Date,
then the Investors shall have the option to convert all or a portion of the
Bridge Notes into shares of common stock, at an effective per share conversion
price equal to 50% of the volume-weighted average price per share of the Common
Stock over the five (5) consecutive trading days immediately preceding the third
business day prior to the Maturity Date.
In
accounting for the Bridge Note OID the Company is amortizing the discount
of $169,703 over the life of the note by increasing the note amount each
reporting period and charging the offset to interest expense.
In
accounting for the Bridge Note’s embedded conversion feature and
warrants described above the Company considered the guidance contained in
EITF 00-19, “Accounting for
Derivative Financial Instruments Indexed To, and Potentially Settled In, a
Company’s Own Common
Stock,” and SFAS 133 “Accounting for Derivative
Instruments and Hedging Activities.” In accordance with the guidance
provided in EITF 05-2 in order to clarify provisions of EITF 00-19, the Company
determined that the conversion feature in the Bridge Notes represented an
embedded derivative since the debenture is convertible into a variable number of
shares based upon a conversion formula which could require the Company to issue
shares in excess of its authorized amount. The convertible debentures are not
considered “conventional” convertible debt under EITF 00-19 and the embedded
conversion feature was bifurcated from the debt host and accounted for as a
derivative liability. The Company measured the fair value of the embedded
derivatives at the commitment date using the Black-Scholes valuation model based
on the following assumptions:
First we
estimated the probability of outcomes that the company would be able to meet the
QEF and trigger a 10% discount on the QEF share price (“QEF Pricing”) or
alternatively not meet the QEF (“Non-QEF Pricing”) and trigger an effective per
share conversion price equal to 50% of the VWAP per share of the Common Stock
over the five (5) consecutive trading days immediately preceding the third
business day prior to the Maturity Date. The Company estimated a 70% probability
that they would be able to meet the QEF Pricing at a price of $0.15 per share of
its common stock and 30% that they would meet the Non-QEF Pricing based on its
knowledge of the Company’s current business strategy and
position. The fair value of the embedded derivative under both
outcomes was determined and then factored for the 70% and 30% outcomes to
estimate the embedded derivative value of $1,023,116 as recorded upon
issuance.
The
Company is required to record the fair market value of the embedded derivatives
at the issuance of the Bridge Notes as an embedded derivative liability
partially offsetting the Bridge Note liability (Convertible Bridge Notes and
fair value of embedded derivative) and then to amortize the value of the
embedded liability over the life of the Note by charging interest expense in the
Statement of Operations and while increasing the value of the Convertible Bridge
Notes. The amount charged to interest expenses for the quarter ended
July 31, 2009 was $54,933. The Company shall also adjust each
reporting period for any changes in fair value of the embedded derivative
liability by recording the change to the Net changes in fair value of common
stock warrant liability and embedded derivative liability in the Statement of
Operations.
The
Black-Scholes valuation method was used based on the following factors. QEF
Pricing factors used at origin (June 18, 2009) was based on a stock closing
price $0.11 per share, exercise price $0.135 per share (10% discount to QEF
Pricing) risk free interest rate 0.34%, volatility 310.97% and life of 196 days.
On July 31, 2009 stock closing price $0.09 per share, exercise price $0.135 per
share, risk free interest rate .26%, volatility 271.13% and life of 153
days. This initial embedded derivative liability of $1,023,116,
will be adjusted to fair value at each reporting period based on the current
assumptions at that time. The increase or decrease in the fair market value of
the embedded conversion feature at each reporting period will result in a
non-cash income or expense which is recorded in other income (expense) in the
Statement of Operations along with corresponding changes in the fair value of
the liability. As of July 31, 2009, the fair value of the embedded
derivative was adjusted by $231,727 resulting in a reduction of the embedded
derivative liability and a corresponding amount to other income. The
balance for the embedded derivative liability was $791,389 at July 31,
2009.
Accounting
for all outstanding warrants related to the Company’s determination that all of
the outstanding warrants should be reclassified as liabilities due the fact that
the conversion feature on the Bridge Notes could require the Company to issue
shares in excess of its authorized amount. All outstanding warrants
have been recorded as a liability effective June 18, 2009, based on their fair
value calculated using the Black-Scholes-Merton valuation model and the
following assumptions: First the Company estimated the probability of
three different outcomes (i) that the Company would be able to meet the QEF at
the current warrant price of $0.20 per share, (ii) the QEF price would be $0.15
per share and trigger a 10% discount and (iii) not meet the QEF (“Non-QEF
Pricing”) and trigger an effective per share conversion price equal to 50% of
the VWAP per share of the Common Stock over the five (5) consecutive trading
days immediately preceding the third business day prior to the Maturity Date.
The Company’s estimated that there was and equal probability for each
scenario. The fair value of the warrant liability under each outcome
was determined and then averaged the outcomes to estimate the warrant value of
$13,036,087 at June 18, 2009.
This
initial warrant liability triggered by the Bridge Notes of $13,036,087 as an
reduction to the Bridge Notes liability of $250,392 for warrants issued in
connection with the bridge notes and a reduction to additional paid in capital
in the amount of $12,785,695 for all previously issued and outstanding warrants.
The Company will continue to measure the fair value of the warrants at each
reporting date using the Black-Scholes-Merton valuation model based on the
current assumptions at that point in time. The increase or decrease in the fair
market value of the warrants at each reporting period will result in a non-cash
income or expense which is recorded the Net changes in fair value of common
stock warrant liability and embedded derivative liability in the Statement of
Operations along with corresponding changes in fair value of the common stock
warrant liability. As of July 31, 2009, the fair value of the warrants was
calculated using the following assumptions:
The
Black-Scholes valuation method was used based on the following factors based on
the date of origin June 18, 2009:
|
(i)
|
$0.20
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 312.32%, 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 312.32%, 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 312.32%, Life 620 to 1825 days, warrants outstanding
202,416,414
|
The
Black-Scholes valuation method was used based on the following factors used as
of July 31,2009:
|
(i)
|
$0.20
exercise price, market price $0.09, risk free interest 0.18% to 2.53%,
volatility 170.16% to 294.68%, Life 102 to 1782 days warrants outstanding
89,143,801.
|
|
(ii)
|
$0.135
exercise price, market price $0.09, risk free interest 0.18% to 2.53%,
volatility 170.16% to 294.68%, Life 102 to 1782 days, warrants outstanding
123,269,393
|
|
(iii)
|
$0.055
exercise price, market price $0.09, risk free interest 0.8% to 2.53%,
volatility 170.16% to 294.68%, Life 579 to 1782 days warrants outstanding
244,073,417
|
The
convertible notes payable can not be converted under outcome number (iii) above
until three days prior to the due date of the notes of December 31,
2009. In this scenario, 31,375,845 warrants with expiration dates
expire prior to this date would expire worthless. These warrants do
not have a value in the valuation under outcome number (iii) above.
The
change in fair value of the warrants resulted in a reduction to the common stock
warrant liability and other income of $1,782,493 for the three-month period
ending July 31, 2009.
The
Company will continue to measure the fair value of the warrants and embedded
conversion features at each reporting date using the Black-Scholes-Merton
valuation model based on the current assumptions at that point in time. The
increase or decrease in the fair market value of the warrants and embedded
conversion feature at each reporting period will result in a non-cash income or
expense which is recorded in other income (expense) in the Statement of
Operations along with corresponding changes n fair value of the
liability.
We
believe the assumptions used to estimate the fair values of the warrants are
reasonable.
FAS 129
Disclosures about Segments of Enterprise and Related Information applies to
contingently convertible securities.
If in the
event the Company does not consummate a QEF from and after August 1, 2009 and
prior to the second business day immediately preceding the Maturity Date, then
the Investors shall have the option to convert all or a portion of the Bridge
Notes into shares of common stock, at an effective per share conversion price
equal to 50% of the VWAP per share of the Common Stock over the five (5)
consecutive trading days immediately preceding the third business day prior to
the Maturity Date then the following table provides a range of the
dilution:
If the
five-day VWAP per share the Common Stock at a 50% conversion feature
is:
|
·
|
$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) .
|
(1) Based
on the dilution effect of the ratchets in the Stock Purchase Agreement and
Warrants from the October 17, 2007 raise.
7.
|
Accounting
for Stock-Based Compensation Plans
|
The
Company records compensation expense associated with stock options in accordance
with SFAS No. 123R, “Share Based Payment,” which is a revision of SFAS No. 123.
The Company adopted the modified prospective transition method provided under
SFAS No. 123R. Under this transition method, compensation expense associated
with stock options recognized in the first quarter of fiscal year 2007, and in
subsequent quarters, includes expense related to the remaining unvested portion
of all stock option awards granted prior to April 1, 2006, the estimated fair
value of each option award granted was determined on the date of grant using the
Black-Scholes option valuation model, based on the grant date fair value
estimated in accordance with the original provisions of SFAS No.
123.
The table
below summarizes compensation expenses from share-based payment
awards:
|
|
For the nine
month period
ended July 31,
2009
|
|
|
For the nine
month period
ended July 31,
2008
|
|
Research
and development
|
|
|
143,486 |
|
|
|
474 |
|
General
and Administrative
|
|
|
202,984 |
|
|
|
157,009 |
|
Total
stock compensation expense recognized
|
|
$ |
346,470 |
|
|
$ |
157,483 |
|
Total
unrecognized estimated compensation expense related to non-vested stock options
granted and outstanding as of July 31, 2009 was $730,175, which is expected to
be recognized over a weighted-average period of twenty months.
No
options were exercised over the three months and nine months ended July 31, 2008
and 2009 periods, respectively. In July 2009 our Board of Directors (the
“Board”) approved a grant of 10,700,000 non-plan options at an exercise price of
$0.10 per share, with one-third vesting on July 21, 2009 and the balance to vest
equally over the anniversary of the next two years. The fair value of the grants
is approximately $637,720.
8.
|
Commitments
and Contingencies
|
In the
ordinary course of business, we enter into agreements with third parties that
include indemnification provisions which, in our judgment, are normal and
customary for companies in our industry sector. These agreements are typically
with business partners, clinical sites, and suppliers. In these agreements, we
generally agree to indemnify, hold harmless and reimburse indemnified parties
for losses suffered or incurred by the indemnified parties with respect to our
product candidates, use of such product candidates or other actions taken or
omitted by us. The maximum potential amount of future payments we could be
required to make under these indemnification provisions is unlimited. We have
not incurred material cost to defend lawsuits or settle claims related to these
indemnification provisions. As a result, we have no liabilities recorded for
these provisions. Accordingly, we have no liabilities recorded for these
provisions as of July 31, 2009.
In the
normal course of business, we may be confronted with issues or events that may
result in a contingent liability. These are generally related to lawsuits,
claims, environmental actions or the action of various regulatory agencies, if
necessary, management consults with counsel and other appropriate experts to
assess any matters that arise. If, in Management’s opinion, we have incurred a
probable loss as set forth by accounting principles generally accepted in the
U.S., an estimate is made of the loss and the appropriate accounting entries are
reflected in our financial statements. There are no currently pending or
threatened law suits or claims against the Company that could have a material
adverse effect on our financial position, results of operations or cash
flows.
The
Company issued to a vendor CME Acuity 2,595,944 share of common stock on
December 30, 2008 in full payment for its outstanding balance.. On February 3,
2009 we issued 422,780 shares of common stock to a board of directors member,
Richard Berman, per his compensation agreement. In May 2009 all or
3,333,333 of the warrants purchased for $0.149 per warrant in the October 17,
2007 raise with an exercise price of $0.001were exercised on a cashless basis
and 3,299,999 shares of common stock were issued. In the third
quarter ending July 31, 2009 we entered into agreements with Numoda Corporation,
Stonegate Inc. and others that allows the Company to make $805,800 payments in
the form of Company stock. This stock has not been issued as of July 31,
2009
In
accounting for the Bridge Note’s warrants described above the Company
considered the guidance contained in EITF 00-19, “Accounting for Derivative Financial
Instruments Indexed To, and Potentially Settled In, a Company’s Own Common Stock,” and SFAS
133 “Accounting for Derivative
Instruments and Hedging Activities.” In accordance with the guidance
provided in EITF 05-2 in order to clarify provisions of EITF 00-19, the Company
determined that the conversion feature in the Bridge Notes represented an
embedded derivative since the debenture is convertible into a variable number of
shares based upon a conversion formula which could require the Company to issue
shares in excess of its authorized amount. The convertible debentures are not
considered “conventional” convertible debt under EITF 00-19 and the embedded
conversion feature was bifurcated from the debt host and accounted for as a
derivative liability. Accordingly, the Company is also required to record the
fair value of all of its warrants outstanding as a liability. (See Note 6) The
Company measured the fair value of the warrants at the commitment date using the
Black-Scholes valuation resulting in a $12,785,695 reduction in Additional
Paid-In Capital as July 31, 2009.
Additional Paid-In Capital:
|
|
|
|
Balance
as of October 31, 2008:
|
|
$ |
16,584,414 |
|
Warrants
converted into common stock
|
|
|
(
3,300 |
) |
Common
stock issued to consultants
|
|
|
67,140 |
|
Stock
options granted to employees and consultants
|
|
|
354,515 |
|
Warrant
Liability recorded at inception
|
|
|
(12,785,695 |
) |
Balance
as of July 31, 2009
|
|
$ |
4,217,074 |
|
The
Company issued a note for $10,000 dated November 13, 2003 and a note for $40,000
dated December 17, 2003 to BioAdvance that were each due on their fifth
anniversary date thereof. On November 4, 2009 the Company
reached an agreement with BioAdvance to defer the payment of the $40,000 note
plus interest until the Company exercises its option to require Optimus to
purchase the Company’s Series A preferred stock, pursuant to the terms of the
purchase agreement the Company entered into with Optimus, and paid the $10,000
note plus interest in full on November 4, 2009.
As
of November 3, 2009, the Company completed a private placement with
certain accredited investors pursuant to which the Company issued (i) junior
unsecured convertible promissory notes in the aggregate principal face amount of
$2,088,235, for an aggregate net purchase price of $1,775,000 and (ii) warrants
to purchase 4,437,500 shares of our common stock at an exercise price of $0.20
per share, subject to adjustments upon the occurrence of certain
events. The Company refers to this capital raise as the
October 2009 bridge financing. The Company refers to the notes and
warrants issued in the October 2009 bridge financing as the October 2009 bridge
notes and October 2009 bridge warrants, respectively.
Each
of the October 2009 bridge notes were issued with an original issue discount of
15% and are convertible into shares of our common stock as described
below. $58,824
of the issued October 2009 bridge notes mature on the later of (i) March 31,
2010 and (ii) the repayment in full or conversion of the June 2009 bridge notes
(and any other senior indebtedness), and $2,029,412 of the issued October 2009
bridge notes mature on the later of (i) April 30, 2010 and (ii) the repayment in
full or conversion of the June 2009 bridge notes (and any other senior
indebtedness). The Company may prepay the October 2009 bridge
notes, in whole or in part, without penalty at any time prior to the respective
maturity date. The indebtedness represented by the October 2009
bridge notes is expressly subordinate to our currently outstanding senior
secured indebtedness (including the June 2009 bridge notes), as well as any
future senior indebtedness of any kind. The Company will not make any
payments to the holders of the October 2009 bridge notes until the earlier of
the repayment in full or conversion of the senior
indebtedness.
On
September 24, 2009, the Company entered into a Preferred Stock Purchase
Agreement (the “Purchase Agreement”), with an institutional investor (“the
Investor”) which provides that, the Investor is committed to purchase up to
$5,000,000 of the Company’s newly authorized, non-convertible, redeemable Series
A Preferred Stock, $0.001 par value per share (the “Series A Preferred Stock”),
at a price of $10,000 per share of Series A Preferred Stock. Under the terms of
the Purchase Agreement, from time to time until September 24, 2012, in the
Company’s sole discretion, the Company may present the Investor with a notice to
purchase a specified amount of Series A Preferred Stock (the “Notice”), which
the Investor is obligated to purchase on the 10th trading day after the Notice
date.
On August
19, 2009 the NIH awarded us a grant for $210,000 for the development of a Dual
Antigen Vaccine to develop a single bioengineered Lm vaccine to deliver two
different antigen-adjuvant proteins. This technology enables a single vaccine to
simultaneously attack two separate and distinct tumor targets with a higher
level of potency. Further investigational work is focusing on the use of this
dual delivery approach directed against a tumor cell surface marker to kill
tumor cells directly plus an anti-angiogenic target that would impair a tumor’s
ability to grow by simultaneously reducing its blood supply.
On August
19, 2009 we announced collaboration with investigators with the City of Hope.
The City of Hope is a leading biomedical research and treatment center in the
development of a vaccine for the treatment of certain forms of leukemia and
lymphoma. This collaboration will involve the investigation in the use of our
Live Listeria vaccine
proprietary Lm vaccine technology platform for Leukemia and Lymphoma. The City
of Hope investigators are studying our vaccine directed against the tumor
associated antigen WT-1. This molecule is observed to be over-expressed in
certain cancers of the blood as well as some solid tumors such as breast,
pancreas and brain cancers, which makes it a potential target for a selective
immune attack delivered via an Lm vector designed by the
Company.