PROSPECTUS
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Filed
Pursuant to Rule 424(b)(3)
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Registration
No. 333-168298
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ABOUT
THIS PROSPECTUS
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ii
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PROSPECTUS
SUMMARY
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1 | |||
THE
OFFERING
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5 | |||
RISK
FACTORS
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6 | |||
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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19 | |||
USE
OF PROCEEDS
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21 | |||
MARKET
PRICE OF AND DIVIDENDS ON OUR COMMON STOCK
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AND
RELATED STOCKHOLDER MATTERS
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21 | |||
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
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FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
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22 | |||
DESCRIPTION
OF BUSINESS
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36 | |||
MANAGEMENT
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56 | |||
EXECUTIVE
COMPENSATION
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60 | |||
STOCK
OWNERSHIP
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68 | |||
SELLING
STOCKHOLDERS
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70 | |||
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
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71 | |||
DESCRIPTION
OF OUR CAPITAL STOCK
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71 | |||
SHARES
ELIGIBLE FOR FUTURE SALE
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76 | |||
PLAN
OF DISTRIBUTION
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77 | |||
LEGAL
MATTERS
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79 | |||
EXPERTS
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79 | |||
INTERESTS
OF NAMED EXPERTS AND COUNSEL
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79 | |||
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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79 | |||
INDEX
TO FINANCIAL STATEMENTS
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F-1 |
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; commenced in March 2010 (with patient dosing commencing
in June 2010).
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Cervical
Cancer
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Phase II Company
sponsored study anticipated to commence in July-August 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 has agreed to conduct a
study which we expect will commence in late 2010.
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Head
& Neck Cancer
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Phase I The Cancer
Research UK (CRUK) is funding a study of up to 45 patients at 3 UK
facilities that we expect will commence in October
2010.
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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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·
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senior
to our common stock and any other class or series of preferred stock
(other than Series A preferred stock or any class or series of preferred
stock that we intend to cause to be listed for trading or quoted on
Nasdaq, NYSE Amex or the New York Stock
Exchange);
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·
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pari passu with any
outstanding shares of our Series A preferred stock (none of which are
issued and outstanding as of the date hereof);
and
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·
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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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·
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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 requirements under the Securities Exchange Act of 1934, as
amended, in order to maintain such
listing;
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·
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either
(i) we have a current, valid and effective registration statement covering
the resale of all warrant shares or (ii) all warrant shares are eligible
for resale without limitation under Rule 144 (assuming cashless exercise
of the warrant);
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·
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there
must not be any material adverse effect with respect to our company since
the date of the Series B purchase agreement, other than losses incurred in
the ordinary course of business;
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·
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we
must not be in default under any material
agreement;
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·
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certain
lock-up agreements 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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·
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there
must not be any legal restraint prohibiting the transactions contemplated
by the Series B purchase agreement;
and
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·
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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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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 46,818,000 shares of our common stock (1)
consisting of:
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·
3,500,000 shares of our common stock issued to Numoda Capital as
payment for certain services rendered by one of its affiliates to
us;
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·
2,818,000 shares of our common stock underlying a warrant issued to
an affiliate of Optimus in connection with a tranche closing of our Series
A preferred equity financing; and
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·
40,500,000 shares of our common stock underlying a warrant issued
to an affiliate of Optimus in our Series B preferred equity
financing.
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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. Furthermore, we will not
receive cash proceeds from the exercise of the warrants held by the
affiliate of Optimus to the extent they are exercised by a promissory
note, as permitted by the terms of such warrants.
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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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·
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competition
from companies that have substantially greater assets and financial
resources than we have;
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·
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need
for acceptance of products;
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·
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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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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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·
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dependence
upon key personnel including key independent consultants and
advisors.
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·
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competition
from companies that have substantially greater assets and financial
resources than we have;
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·
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need
for acceptance of products;
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·
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ability
to anticipate and adapt to a competitive market and rapid technological
developments;
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·
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amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
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·
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need
to rely on multiple levels of outside funding due to the length of the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry;
and
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·
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dependence
upon key personnel including key independent consultants and
advisors.
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Preclinical
study results that may show the product to be less effective than desired
(e.g., the study failed to meet its primary objectives) or to have harmful
or problematic side effects;
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·
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Failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by
slow enrollment in clinical studies, length of time to achieve study
endpoints, additional time requirements for data analysis, or Biologics
License Application preparation, discussions with the FDA, an FDA request
for additional preclinical or clinical data, or unexpected safety or
manufacturing issues;
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·
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Manufacturing
costs, formulation issues, pricing or reimbursement issues, or other
factors that make the product uneconomical;
and
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The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
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significant
time and effort from our management
team;
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coordination
of our research and development programs with the research and development
priorities of our collaborators;
and
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·
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effective
allocation of our resources to multiple
projects.
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decreased
demand for our product candidates;
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damage
to our reputation;
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withdrawal
of clinical trial participants;
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costs
of related litigation;
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substantial
monetary awards to patients or other
claimants;
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loss
of revenues;
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·
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the
inability to commercialize product candidates;
and
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·
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increased
difficulty in raising required additional funds in the private and public
capital markets.
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price
and volume fluctuations in the overall stock market from time to
time;
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·
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fluctuations
in stock market prices and trading volumes of similar
companies;
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·
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actual
or anticipated changes in our net loss or fluctuations in our operating
results or in the expectations of securities
analysts;
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·
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the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Series B purchase
agreement;
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·
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general
economic conditions and trends;
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major
catastrophic events;
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sales
of large blocks of our stock;
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·
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significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
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·
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departures
of key personnel;
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·
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changes
in the regulatory status of our product candidates, including results of
our clinical trials;
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·
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events
affecting Penn or any future
collaborators;
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·
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announcements
of new products or technologies, commercial relationships or other events
by us or our competitors;
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regulatory
developments in the U.S. and other
countries;
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·
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failure
of our common stock to be listed or quoted on the Nasdaq Stock Market,
NYSE Amex Equities or other national market
system;
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·
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changes
in accounting principles; and
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discussion
of us or our stock price by the financial and scientific press and in
online investor communities.
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with
a price of less than $5.00 per
share;
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·
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that
are neither traded on a “recognized” national exchange nor listed on an
automated quotation system sponsored by a registered national securities
association meeting certain minimum initial listing standards;
and
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of
issuers with net tangible assets less than $2.0 million (if the issuer has
been in continuous operation for at least three years) or $5.0 million (if
in continuous operation for less than three years), or with average
revenue of less than $6.0 million for the last three
years.
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obtain
from the investor information about his or her financial situation,
investment experience and investment
objectives;
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reasonably
determine, based on that information, that transactions in penny stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions;
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provide
the investor with a written statement setting forth the basis on which the
broker-dealer made his or her determination;
and
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receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment
objectives.
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the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Series B 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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·
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competitive
developments, including announcements by competitors of new products or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
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variations
in quarterly operating results;
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change
in financial estimates by securities
analysts;
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the
depth and liquidity of the market for our common
stock;
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investor
perceptions of our company and the technologies industries generally;
and
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general
economic and other national
conditions.
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statements
as to the anticipated timing of clinical studies and other business
developments;
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statements
as to the development of new
products;
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expectations
as to the adequacy of our cash balances to support our operations for
specified periods of time and as to the nature and level of cash
expenditures; and
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expectations
as to the market opportunities for our products, as well as our ability to
take advantage of those
opportunities.
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Our
limited operating history and ability to continue as a going
concern;
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Our
ability to successfully develop and commercialize products based on our
therapies and the Listeria System;
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A
lengthy approval process and the uncertainty of FDA and other government
regulatory requirements may have a material adverse effect on our ability
to commercialize our applications;
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·
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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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·
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The
degree and nature of our
competition;
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·
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Our
ability to employ and retain qualified employees;
and
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·
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The
other factors referenced in this prospectus, including, without
limitation, under the sections titled “Risk Factors,” “Management’s
Discussion and Analysis and Results of Operations,” and “Description of
our Business.”
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Fiscal 2010
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Fiscal 2009
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Fiscal 2008
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||||||||||||||||||||||
High
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Low
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High
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Low
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High
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Low
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|||||||||||||||||||
First
Quarter (November 1-January 31)
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$ | 0.18 | $ | 0.11 | $ | 0.06 | $ | 0.01 | $ | 0.20 | $ | 0.13 | ||||||||||||
Second
Quarter (February 1- April 30)
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$ | 0.23 | $ | 0.14 | $ | 0.05 | $ | 0.02 | $ | 0.15 | $ | 0.09 | ||||||||||||
Third
Quarter (May 1 - July 31)
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$ | 0.17 |
(1)
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$ | 0.24 |
(1)
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$ | 0.21 | $ | 0.04 | $ | 0.135 | $ | 0.058 | ||||||||||
Fourth
Quarter (August 1 - October 31)
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$ | - | $ | - | $ | 0.19 | $ | 0.06 | $ | 0.07 | $ | 0.03 |
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senior
to our common stock and any other class or series of preferred stock
(other than Series A preferred stock or any class or series of preferred
stock that we intend to cause to be listed for trading or quoted on
Nasdaq, NYSE Amex or the New York Stock
Exchange);
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·
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pari passu with any
outstanding shares of our Series A preferred stock (none of which are
issued and outstanding as of the date hereof);
and
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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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·
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Continue
to raise funding to recruit patients in our U.S. based Phase II clinical
study of ADXS11-001 in the therapeutic treatment of CIN and our Indian
based Phase II study in late stage cervical
cancer;
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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 Lm vaccine to deliver
two different antigen-adjuvant
proteins.
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·
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Continue
to focus on our collaboration with the Gynecologic Oncology Group, which
we refer to as the GOG, to carry out our Phase II clinical trial of our
ADXS11-001 candidate in the treatment of cervical cancer largely
underwritten by the National Cancer Institute, which we refer to as the
NCI;
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·
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Continue
to focus on our collaboration with the CRUK to carry out our Phase II
clinical trial of our ADXS11-001 candidate in the treatment of head and
neck cancer largely underwritten by the
CRUK;
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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.
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·
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Cost
incurred to date: approximately $1.1
million
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·
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Estimated
future clinical costs: $7.7 million to $8.0
million
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·
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Anticipated
Timing: commenced in March 2010 (with patient dosing commencing in June
2010); completion August 2012 or
beyond
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·
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The
FDA (or relevant foreign regulatory authority) may place the project on
clinical hold or stop the project;
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·
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One
or more serious adverse events in otherwise healthy patients enrolled in
the trial;
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·
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Difficulty
in recruiting patients;
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·
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Delays
in the program;
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·
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Material
cash flows; and
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·
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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.
|
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·
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Cost
incurred to date: approximately
$101,650
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|
·
|
Estimated
future clinical costs: $2.7 million to $3.3
million
|
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·
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Anticipated
Timing: start July-August; completion August 2012 or
beyond
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·
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One
or more serious adverse events in these late stage cancer patients
enrolled in the trial; and
|
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·
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Difficulty
in recruiting patients especially in a new
country.
|
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·
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Cost
incurred to date: less than $10,000
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·
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Estimated
future clinical costs: $500,000 (Government absorbed cost $2.5 million to
$3.0 million)
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·
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Anticipated
Timing: The GOG of the NCI has agreed to conduct a study which we expect
will commence in late 2010
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·
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Unknown
timing in recruiting patients and conducting the study based on GOG/NCI
controlled study;
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·
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Delays
in the program; and
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·
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Given
the economic environment the trial may not get
funded.
|
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·
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Cost
incurred to date: less than $15,000
|
|
·
|
Estimated
future clinical costs: expected to be greater than $50,000 (CRUK to
absorbe cost $2.5 million to $3.0
million)
|
|
·
|
Anticipated
Timing: The CRUK is funding a study of up to 45 patients at 3 UK
facilities that we expect will commence in October
2010.
|
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·
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Unknown
timing in recruiting patients and conducting the study based on CRUK
controlled study;
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·
|
Delays
in the program; and
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·
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Given
the economic environment the trial may not get
funded.
|
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·
|
Cost
incurred to date: approximately
$200,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
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New
agent; and
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·
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FDA
(or foreign regulatory authority) may not approve the
study.
|
|
·
|
Cost
incurred to date: $450,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Clinical
trial expenses increased by $750,511, to $751,242 from $731, due to our
clinical trial activity initiated during the first fiscal quarter of
2010.
|
|
·
|
Wages,
including stock-based compensation approximately $64,000, or 28% to
$291,649 from $227,456, primarily as a result of increased salaries
(including an executive bonus) and increased stock-based compensation
resulting from the 2009 stock option
plan.
|
|
·
|
Legal
expenses increased approximately $16,000, which was more than offset by
consulting costs which decreased by about
$27,000.
|
|
·
|
Salaries
and employee benefits increased by approximately $170,000, or 90% to
$357,785 from $188,094 a year ago, due to higher salaries and health
insurance premiums.
|
|
·
|
Stock-based
compensation increased by $40,629, to $50,028 from $9,399 a year ago, due
to the issuance of new options under the 2009 stock option
plan.
|
|
·
|
Legal
and accounting fees increased by $125,226, to $180,675 from $55,449,
primarily as a result of increased legal fees of $83,634 and increased
accounting fees of $41,492, which were more than offset by a decrease in
offering expenses of $47,393 due to the application of financing costs to
additional paid-in capital.
|
|
·
|
Interest Expense. For
the Current Three-Month Period, interest expense increased by $1,626,411,
to $1,647,069 from $20,658 in the Prior Three-Month Period primarily due
to the sale of senior and junior bridge notes during the third and fourth
fiscal quarters of 2009 and the six months ended April 30, 2010.
Additionally warrant liabilities and embedded derivatives related to the
senior and junior bridge notes are recorded as a liability on the balance
sheet and are amortized to interest expense over the life of the senior
and junior bridge notes.
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|
·
|
Changes in Fair Values.
The change in fair value of the common stock warrant liability and
embedded derivative liability increased expense by approximately $5.8
million in the Current Three-Month Period, compared to $0 in the Prior
Three-Month Period. Of the $5.8 million in expense, $5.4 million related
to the change in fair value of the warrant liability and $0.4 million
related to the change in fair value of the embedded derivative liability.
This change in fair value, using the BSM model, measures the value of the
warrant liability and embedded derivative liability at each reporting
period. Any change in fair value of the liability from the prior period is
recorded in the statement of operations as income if the value of the
liability decreases and expense if the value of the liability
increases.
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|
·
|
Clinical
trial expenses increased by $1,482,907, to $1,484,676 from $1,769,
primarily due to our clinical trial activity initiated during the first
fiscal quarter of 2010.
|
|
·
|
Salaries,
including stock-based compensation, increased by approximately $70,000,
primarily as a result of increased stock-based compensation expense and
salaries. Additionally, in the Current Six-Month Period, a bonus accrual
was reversed, lowering expenses by approximately $122,000 in that
period.
|
|
·
|
Consulting
expenses decreased by $49,960, or 92%, to $4,500 in the Current Six-Month
Period from $54,460, due to a decline in the number of consultants we used
and no stock-based compensation in the Prior Six-Month
Period.
|
|
·
|
Salaries
and related expenses increased by approximately $144,000, or 35% to
$556,123 from $411,653 due to wages and benefits increasing by
approximately $119,000 from higher salaries and increased health insurance
premiums partially offset by lower 401K expenses of approximately $9,000.
Additionally, in the Current Six-Month Period, a bonus accrual was
reversed, lowering expenses by approximately $36,000 in that
period.
|
|
·
|
Stock-based
compensation increased $112,181, to $157,873 from $45,692 a year ago, due
to the issuance of new options under the 2009 stock option
plan.
|
|
·
|
Legal
and accounting fees increased by approximately $190,000, primarily as a
result of higher legal fees of approximately $148,000 and higher
accounting fees of approximately $43,000 due to increased utilization of
temporary professionals and outside auditor fees in the Current Six-Month
Period, which were more than offset by a decrease in offering expenses of
approximately $142,000 due to the application of financing costs to
additional paid-in capital.
|
|
·
|
Patent
expenses decreased approximately $77,000 due to lower amounts paid to Penn
under our licensing agreement, offset by higher regulatory costs of
approximately $10,000.
|
|
·
|
Interest Expense. In
the Current Six-Month Period interest expense increased by $3,277,156 to
$3,313,208 from $36,052 in the Prior Six-Month Period primarily due to the
sale of senior and junior bridge notes during the third and fourth fiscal
quarters of 2009 and the six months ended April 30, 2010. Additionally,
the debt discount on warrant liabilities and embedded derivatives related
to the senior and junior bridge notes are recorded as a liability on the
balance sheet and are amortized to interest expense over the life of the
senior and junior bridge notes.
|
|
·
|
Changes in Fair Values.
The change in fair value of the common stock warrant liability and
embedded derivative liability increased expense by $6,875,371 in the
Current Six-Month Period, compared to $0 in the Prior Six-Month Period. Of
the $6.9 million in expense, $7.3 million related to the change in fair
value of the warrant liability and ($0.4) million related to the change in
fair value of the embedded derivative liability. This change in fair
value, using the BSM model, measures the value of the warrant liability
and embedded derivative liability at each reporting period. Any change in
fair value of the liability from the prior period is recorded in the
statement of operations as income if the value of the liability decreases
and expense if the value of the liability
increases.
|
|
·
|
Clinical
trial expenses increased by $866,111, or 304%, to $1,150,880 from $284,769
primarily due to the close out of our Phase I trial in the Fiscal 2008
Period which was offset by the start-up costs of our Phase II cervical
cancer study in India and CIN study in the US both in the Fiscal 2009
Period.
|
|
·
|
Wages,
options and lab costs decreased by $215,180 or 18% to $969,639 from
$1,184,819 principally due to the recording of the full year’s bonus
accrual in Fiscal 2008 that was reversed in Fiscal 2009 Period or
$279,558. No bonus accrual was recorded nor paid in Fiscal 2009 Period.
Overall the lab costs were lower by $80,387 due to the priority given to
the lower cost of grant and publication writing. These lower costs were
partially offset by $120,182 in higher option expense relating to new
grants in Fiscal 2009 Period and $24,583 in wages primarily due to the new
hire of the Executive Director, Product Development in March
2008.
|
|
·
|
Consulting
expenses decreased by $25,195, or 18%, to $114,970 from $140,165,
principally due to higher option expense of $54,903 recorded in Fiscal
2009 Period relating to the true-up of unvested options at higher stock
prices compared to a credit to option expense of $42,307 due to the true
up of unvested option expense recorded in prior fiscal periods at lower
stock prices. This increase of option expense which was offset in part by
the lower effort required to prepare the IND filing for the FDA or $80,098
in the Fiscal 2009 Period compared to the same period last
year.
|
|
·
|
Subcontracted
research expenses decreased by $172,473, or 100%, to $0 from $172,473
reflecting the completion of the project prior to Fiscal 2009 Period
performed by Dr. Paterson at Penn, pursuant to a sponsored research
agreement ongoing in the Fiscal 2008
Period.
|
|
·
|
Manufacturing
expenses decreased by $592,907, to $80,067 from $672,974, or 88% resulting
from the completion of our clinical supply program for the upcoming phase
II trials prior to Fiscal 2009 Period compared to the manufacturing
program in the Fiscal 2008 Period.
|
|
·
|
Toxicology
study expenses decreased by $26,640, to $0 or 100% due the completion in
Fiscal 2008 Period of our toxicology study by Pharm Olam in connection
with our ADXS111-001 product candidates in anticipation of clinical
studies in 2008.
|
|
·
|
Wages,
Options and benefit expenses decreased by $40,953, or 3% to $1,169,227
from $1,210,180 principally due to the reversal of a twelve month bonus
accrual in Fiscal 2009 Period or $89,877 that was recorded as expense in
Fiscal 2008 Period (no bonus accrual was recorded nor paid in Fiscal 2009
Period) and less stock was issued in Fiscal 2009 Period compared to
$43,030 worth of stock was issued primarily to the CEO per his employment
agreement in Fiscal 2008 Period. These lower expenses were partially
offset by higher option expense of $77,949 primarily due to new stock
options granted in Fiscal 2009 Period and $14,005 in overall higher wages
and related fees in the Fiscal 2009 Period than Fiscal 2008
Period.
|
|
·
|
Consulting
fees decreased by $350,136, or 82%, to $77,783 from $427,919. This
decrease was primarily attributed to a one-time payment in settlement of
Mr. Appel’s (our previous President & CEO) employment agreement of
$144,615 recorded in the Fiscal 2008 Period. In addition, consulting
expenses were sharply down by $255,521 due to no financial advisor fees in
Fiscal 2009 Period compared to $256,571 recorded in the Fiscal 2008 Period
attributed to the close of the October 17, 2007 offering. These lower fees
were partially offset by $50,000 fees recorded for the Sage Group
(Business Development Consultants) in Fiscal 2009 Period for seeking
corporate partnerships that didn’t occur in Fiscal 2008
Period.
|
|
·
|
Offering
expenses increased by $396,128 to $449,646 from $53,518. The $396,128
increase in offering expenses recorded in Fiscal 2009 Period consists of
legal costs in preparation for financial raises and SEC filings that
didn’t occur in Fiscal 2008 Period, partially offset by non-cash warrants
expense.
|
|
·
|
Increases
in legal, accounting, professional and public relations expenses of
$77,389, or 14%, to $643,032 from $565,643, primarily as a result of a
higher overall legal, patent expenses and filing fees of $107,870
partially offset by lower public relations and tax preparation fees in
Fiscal 2009 Period than in the Fiscal 2008
Period.
|
|
·
|
Amortization
of intangibles and depreciation of fixed assets decreased by $86,189, or
44%, to $111,156 from $197,345 primarily due to a $91,453 write-off of our
trademarks in the Fiscal 2008 Period partially offset by an increase in
fixed assets and intangibles in the Fiscal 2009 Period compared to the
Fiscal 2008 Period.
|
|
·
|
Analysis
Research cost decreased by $101,949 or 100%, to $0 from $101,949 due to a
one time report and business analysis report in the Fiscal 2008 Period not
repeated in Fiscal 2009 Period.
|
|
·
|
Recruiting
fees for the Executive Director of Product Development in Fiscal 2008
Period was $63,395 and there was no such expense in Fiscal 2009
Period.
|
|
·
|
Overall
occupancy and conference related expenses decreased by $165,442 or 40% to
$250,290 from $415,732. Conference and dues and subscription expenses have
decreased by $145,396 in the Fiscal 2009 Period due to lower participation
in cancer conferences. In addition lower travel related to the reduced
conferences attendance, taxes and other miscellaneous expenses amounted to
a decrease of $20,046 in the Fiscal 2009 Period than incurred in Fiscal
2008 Period.
|
|
·
|
It
requires assumption to be made that were uncertain at the time the
estimate was made, and
|
|
·
|
Changes
in the estimate of difference estimates that could have been selected
could have material impact in our results of operations or financial
condition.
|
Indication
|
Stage
|
|||
ADXS11-001
|
Cervical
Cancer
|
Phase I Company
sponsored & completed in 2007.
|
||
Cervical
Intraepithelial Neoplasia
|
Phase II Company
sponsored study; commenced in March 2010 (with patient dosing commencing
in June 2010).
|
|||
Cervical
Cancer
|
Phase II Company
sponsored study anticipated to commence in July-August 2010 in India. 110
Patients with advanced cervical cancer.
|
|||
Cervical
Cancer
|
Phase II The Gynecologic
Oncology Group of the National Cancer Institute has agreed to conduct a
study which we expect will commence in late 2010.
|
|||
Head
& Neck Cancer
|
Phase I The Cancer
Research UK (CRUK) is funding a study of up to 45 patients at 3 UK
facilities that we expect will commence in October
2010.
|
|||
ADXS31-142
|
Prostate
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
|
Breast
Cancer
|
|
Phase I Company
sponsored (timing to be
determined).
|
|
1.
|
Very
strong innate immune response
|
|
2.
|
Stimulates
inordinately strong killer Tregs
response
|
|
3.
|
Stimulates
helper Tregs
|
|
Stimulates
release of and/or up-regulates immuno-stimulatory cytokines, chemokines,
co-stimulatory molecules
|
|
5.
|
Adjuvant
activity creates a local tumor environment that supports anti-tumor
efficacy
|
|
6.
|
Minimizes
inhibitory Tregs and inhibitory cytokines and shifts to Th-17
pathway
|
|
7.
|
Stimulates
the development and maturation of all Antigen Presenting Cells and
effector Tregs & reduces immature myeloid
cells
|
|
8.
|
Eliminates
sources of endogenous inhibition present within tumors that suppress
activated immune cells and prevent them from working within
tumors
|
|
9.
|
Effecting
non-immune systems that support the immune response, like the vascular
system, the marrow, and the maturation of cells in the blood
stream
|
|
10.
|
Enables
epitope spreading to increase the number of antigens attacked by the
immune system.
|
|
·
|
Who
must be recruited as qualified participants and who is to be
excluded;
|
|
·
|
how
often, and how to administer the drug and at what
dose(s);
|
|
·
|
what
tests to perform on the participants;
and
|
|
·
|
what
evaluations are to be made and how the data will be
assessed.
|
Name
|
Age
|
Position
|
||
Thomas
A. Moore
|
59
|
Chief
Executive Officer and Chairman of our Board of
Directors
|
||
Dr.
James Patton
|
51
|
Director
|
||
Roni
A. Appel
|
42
|
Director
|
||
Dr.
Thomas McKearn
|
60
|
Director
|
||
Richard
Berman
|
67
|
Director
|
||
John
Rothman, Ph.D.
|
61
|
Executive
Vice President of Clinical and Scientific Operations
|
||
Mark
J. Rosenblum
|
56
|
Chief
Financial Officer, Senior Vice President and
Secretary
|
|
·
|
recommending
the engagement of auditors to the full board of
directors;
|
|
·
|
reviewing
the results of the audit engagement with the independent registered public
accounting firm;
|
|
·
|
identifying
irregularities in the management of our business in consultation with our
independent accountants, and suggesting an appropriate course of
action;
|
|
·
|
reviewing
the adequacy, scope, and results of the internal accounting controls and
procedures;
|
|
·
|
reviewing
the degree of independence of the auditors, as well as the nature and
scope of our relationship with our independent registered public
accounting firm;
|
|
·
|
reviewing
the auditors’ fees; and
|
|
·
|
recommending
the engagement of auditors to the full board of
directors.
|
|
·
|
identifying
and recommending to the board of directors individuals qualified to serve
as members of our board of directors and on the committees of the
board;
|
|
·
|
advising
the board with respect to matters of board composition, procedures and
committees;
|
|
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally
including review of possible conflicts and transactions with persons
affiliated with directors or members of management;
and
|
|
·
|
overseeing
the annual evaluation of the board and our
management.
|
|
·
|
The
name, age, business address and residence address of the
person;
|
|
·
|
The
principal occupation or employment of the
person;
|
|
·
|
The
number of shares of our common stock which the person owns beneficially or
of record; and
|
|
·
|
Any
other information relating to the person that must be disclosed in a proxy
statement or other filings required to be made in connection with
solicitations of proxies for election of directors under Section 14 of the
Exchange Act and its rules and
regulations.
|
|
·
|
The
stockholder’s name and record
address;
|
|
·
|
The
number of shares of our common stock that the stockholder owns
beneficially or of record;
|
|
·
|
A
description of all arrangements or understandings between the stockholder
and each proposed nominee and any other person or persons, including their
names, pursuant to which the nomination is to be
made;
|
|
·
|
A
representation that the stockholder intends to appear in person
or by proxy at the annual meeting to nominate the person or persons named
in such stockholder’s notice; and
|
|
·
|
Any
other information about the stockholder that must be disclosed in a proxy
statement or other filings required to be made in connection with
solicitations of proxies for election of directors under Section 14 of the
Exchange Act and its rules and
regulations.
|
Name and
Principal
Position
|
Fiscal Year
|
Salary
|
Bonus
|
Stock
Award(s)
(1)
|
Option
Award(s)
(1)
|
All Other
Compensation
|
Total
|
|||||||||||||||||||
|
|
|||||||||||||||||||||||||
Thomas
A. Moore,
|
2009
|
$ | 350,000 | $ | — | $ | 71,250 | (2) | $ | 115,089 | $ | 17,582 | (3) | $ | 553,919 | |||||||||||
CEO
and Chairman
|
2008
|
352,692 | — | — | 156,364 | 27,626 | (4) | 536.682 | ||||||||||||||||||
Dr.
John Rothman,
|
2009
|
250,000 | — | 11,550 | (5) | 82,911 | 23,797 | (6) | 368,258 | |||||||||||||||||
Executive
VP of Science
&
Operations
|
2008
|
255,000 | 55,000 | 23,378 | (5) | 25,092 | 27,862 | (6) | 386,332 | |||||||||||||||||
Fredrick
D. Cobb,
|
2009
|
180,000 | — | 29,167 | (7) | 55,117 | 7,685 | (6) | 271,968 | |||||||||||||||||
VP
Finance
|
2008
|
182,923 | 40,000 | 15,585 | (8) | 19,977 | 7,136 | (6) | 265,621 |
(1)
|
The
amounts shown in this column represent the compensation expense incurred
by us for the fiscal year in accordance with FAS 123(R) using the
assumptions described under “ Share-Based Compensation
Expense ” in Note 2 to our financial statements included elsewhere
in this prospectus.
|
(2)
|
Represents
750,000 shares of our common stock granted to Mr. Moore based on the
financial raise milestone in his employment agreement valued at the market
close price on April 4, 2008.
|
(3)
|
Based
on our cost of Mr. Moore’s coverage for health
care.
|
(4)
|
Based
on our cost of Mr. Moore’s coverage for health care and interest received
for the Moore Notes.
|
(5)
|
Represents:
(i) $30,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 150,000 shares earned, but not issued, in 2009 and 196,339 shares
earned, but not issued, in 2008.
|
(6)
|
Based
on our cost of his coverage for health care and the 401K company match he
received.
|
(7)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the daily average closing stock price per month
retrospectively to January 1, 2008, and (ii) the compensation expense
incurred in connection with 704,342 shares earned, but not
issued.
|
(8)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 130,893 shares earned, but not
issued.
|
Option
Awards
|
Stock
Awards
|
|||||||||||||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Equity
Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)
|
Market Value
of Shares or
Units of Stock
That Have
Not Vested ($)
|
Equity Incentive
Plan Awards:
Number of
Unearned
Shares, Units or
Other Rights
That Have Not
Vested (#)
|
Equity Incentive
Plan Awards:
Market or Payout
Value of
Unearned Shares,
Units or Other
Rights That Have
Not
Vested
($)
|
|||||||||||||||||||
Thomas
A. Moore
|
833,333
|
1,666,667
|
(1)
|
—
|
0.100
|
7/21/19
|
—
|
$
|
—
|
—
|
—
|
|||||||||||||||||
2,400,000
|
—
|
—
|
0.143
|
12/15/16
|
750,000
|
(2)
|
97,500
|
(3)
|
—
|
—
|
||||||||||||||||||
Dr.
John Rothman
|
583,333
|
1,166,667
|
(4)
|
—
|
0.100
|
7/21/19
|
—
|
—
|
—
|
—
|
||||||||||||||||||
360,000
|
—
|
—
|
0.287
|
3/1/15
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
131,250
|
18,750
|
(5)
|
—
|
0.260
|
3/29/16
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
187,500
|
131,250
|
(6)
|
—
|
0.165
|
2/15/17
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
Fredrick
D. Cobb
|
333,333
|
666,667
|
(7)
|
—
|
0.100
|
7/21/19
|
—
|
—
|
—
|
—
|
||||||||||||||||||
131,250
|
18,750
|
(8)
|
—
|
0.265
|
2/20/16
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
112,500
|
37,500
|
(9)
|
—
|
0.160
|
9/21/16
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
93,750
|
56,250
|
(10)
|
—
|
0.165
|
2/15/17
|
—
|
—
|
—
|
—
|
(1)
|
Of
these options, approximately 833,333 became exercisable on July 21, 2010
and approximately 833,333 will become exercisable on July 21,
2011.
|
(2)
|
In
connection with our hiring of Mr. Moore, we agreed to grant Mr. Moore up
to 1,500,000 shares of our common stock, of which 750,000 shares were
issued on April 4, 2008 upon our successful raise of $4.0 million and
750,000 shares were issued on June 29, 2010 upon our successful raise of
an additional $6.0 million (which condition was satisfied in January
2010).
|
(3)
|
Based
on the closing sale price of $0.13 per share of common stock on October
31, 2009 (the last day of our fiscal
year).
|
(4)
|
Of
these options, approximately 583,333 became exercisable on July 21, 2010
and approximately 583,333 will become exercisable on July 21,
2011.
|
(5)
|
Of
these options, 9,375 became exercisable on each of December 29, 2009 and
March 29, 2010.
|
(6)
|
Of
these options, 18,750 became exercisable on each of November 15, 2009,
February 15, 2010 and May 15, 2010, and 18,750 will become exercisable on
August 15, 2010, November 15, 2010 and February 15,
2011.
|
(7)
|
Of
these options, none will become exercisable as Mr. Cobb is no longer
employed by our company.
|
(8)
|
Of
these options, 9,375 became exercisable on each of November 20, 2009 and
February 20, 2010.
|
(9)
|
Of
these options, 9,375 became exercisable on each of December 21, 2009 and
March 21, 2010. The remaining 18,750 options will not be exercisable as
Mr. Cobb is no longer employed by our
company.
|
(10)
|
Of
these options, 9,375 became exercisable on each of November 15, 2009 and
February 15, 2010. The remaining 37,500 options will not be exercisable as
Mr. Cobb is no longer employed by our
company.
|
Name
|
Fees
Earned
or Paid
in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)(1)
|
All other
Compensation
($)
|
Total
($)
|
|||||||||||||||
Roni
A. Appel
|
$ | 7,500 | $ | 1,848 | (2) | $ | 12,464 | (3) | — | $ | 21,812 | |||||||||
Dr.
James Patton
|
11,250 | 1,848 | (2) | 12,464 | (3) | — | 25,562 | |||||||||||||
Dr.
Thomas McKearn
|
10,500 | 1,848 | (2) | 23,518 | (4) | — | 35,866 | |||||||||||||
Richard
Berman
|
3,750 | 31,840 | (5) | 21,972 | (6) | — | 57,563 |
(1)
|
The
amounts shown in this column represent the compensation expense incurred
by us for the fiscal year in accordance with FAS 123(R) using
the assumptions described under “Share –Based Compensation Expense” in
Note 2 to our financial statements included elsewhere in this
prospectus.
|
(2)
|
Represents
6,000 shares a quarter earned (but not paid or issued) if the member
attends at least 75% of the meetings
annually.
|
(3)
|
Based
on the vesting of 350,000 options of our common stock granted on July 21,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant
date.
|
(4)
|
Based
on the vesting of 500,000 options of our common stock granted on July 21,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant date. Based on
the vesting of 150,000 options of our common stock granted on March 29,
2006 at a market price of $0.261 share. Vests quarterly over a
three year period at a fair value of $0.1434 share value Black Scholes
Model at grant date.
|
(5)
|
Based
on the average monthly closing prices of our common stock for the $2,000
monthly compensation. The total shares earned but not issued in fiscal
year 2009 was 325,765.
|
(6)
|
Based
on the vesting of 500,000 options of our common stock granted on July 23,
2009 at a market price of $0.10 share. Vests at a rate of one-third on the
anniversary date of grant and one-third over the next two years at a fair
value of $0.09 share value (Black Scholes Model) at grant
date. Based on the vesting of 400,000 options of our common
stock granted at $0.287 per share on February 1, 2005. These
options vested quarterly over the next four
years.
|
|
·
|
each
person who is known by us to be the beneficial owner of more than 5% of
our outstanding common stock;
|
|
·
|
each
of our directors;
|
|
·
|
each
of our named executive officers;
and
|
|
·
|
all
of our directors and executive officers as a
group.
|
Name and Address
of Beneficial Owner
|
Number of
Shares of our Common
Stock
Beneficially Owned
|
Percentage
of Class
Beneficially Owned
|
||||||
Thomas
A. Moore
|
9,418,838 | (1) | 5.4 | % | ||||
Roni
A. Appel
|
6,784,558 | (2) | 3.9 | % | ||||
Richard
Berman
|
1,890,078 | (3) | 1.1 | % | ||||
Dr.
James Patton
|
3,211,163 | (4) | 1.9 | % | ||||
Dr.
Thomas McKearn
|
829,387 | (5) | * | |||||
Dr.
John Rothman
|
3,411,987 | (6) | 2.0 | % | ||||
Fredrick
Cobb**
|
1,569,561 | (7) | * | |||||
Mark
J. Rosenblum
|
333,333 | (8) | * | |||||
All
Current Directors and Executive Officers as a Group (7
people)
|
25,879,344 | (9) | 14.1 | % |
(1)
|
Represents
5,352,171 issued shares of our common stock and options to purchase
4,066,667 shares of our common stock exercisable within 60
days. However, it excludes warrants to purchase 4,889,760
shares of our common stock, limited by a 4.99% beneficial ownership
provision in the warrants that would prohibit him from exercising any of
such warrants to the extent that upon such exercise he, together with his
affiliates, would beneficially own more than 4.99% of the total number of
shares of our common stock then issued and outstanding (unless Mr. Moore
provides us with 61 days' notice of the holders waiver of such
provisions).
|
(2)
|
Represents
4,130,134 issued shares of our common stock, options to purchase 2,612,424
shares of our common stock exercisable within 60 days and 42,000 shares of
our common stock earned but not yet
issued.
|
(3)
|
Represents
760,624 issued shares of our common stock, options to purchase 733,334
shares of our common stock exercisable within 60 days and 396,120 shares
of our common stock earned but not yet
issued.
|
(4)
|
Represents
2,820,576 issued shares of our common stock, options to purchase 306,587
shares of our common stock exercisable within 60 days and 84,000 shares
earned but not yet issued.
|
(5)
|
Represents
179,290 issued shares of our common stock, options to purchase 566,097
shares of our common stock exercisable within 60 days and 84,000 shares of
our common stock earned but not yet
issued.
|
(6)
|
Represents
275,775 issued shares of our common stock, options to purchase 1,920,416
shares of our common stock exercisable within 60 days and 1,215,796 shares
of our common stock earned but not yet
issued.
|
(7)
|
Represents
90,336 issued shares of our common stock, options to purchase 727,083
shares of our common stock exercisable within 60 days and
752,142 shares of our common stock earned but not yet
issued.
|
(8)
|
Represents
options to purchase 333,333 shares of our common stock exercisable within
60 days.
|
(9)
|
Represents
an aggregate of 13,518,570 shares of our common stock, options to purchase
10,538,858 shares of our common stock exercisable within 60 days, and
1,821,916 shares of our common stock earned but not yet
issued.
|
Selling Stockholder
|
Shares
Beneficially
Owned
Before
Offering (1)
|
Shares
Being
Offered (2)
|
Shares to be
Beneficially
Owned After
Offering
|
Percentage
to be
Beneficially
Owned After
Offering
|
||||||||||||
Numoda
Capital Innovations, LLC (3)
|
3,500,000 | 3,500,000 | — | — | ||||||||||||
Optimus
CG II, Ltd. (4)
|
2,818,000 | 43,318,000 | — | — |
(1)
|
Except
as otherwise indicated in the footnotes to this table, the number and
percentage of shares beneficially owned is determined in accordance with
Rule 13d-3 of the Exchange Act, and the information is not necessarily
indicative of beneficial ownership for any other purpose. Under such rule,
beneficial ownership includes any shares as to which the selling
stockholder has sole or shared voting power or investment power and also
any shares, which the selling stockholder has the right to acquire within
60 days.
|
(2)
|
Except
as otherwise described herein, shares being offered consists of shares of
our common stock underlying warrants issued in connection with our 2007
private placement (including additional shares of common stock issuable
upon those warrants as a result of certain anti dilution protection
provisions contained therein).
|
(3)
|
Numoda
Capital Innovations, LLC is an affiliate of the Numoda
Corporation. Voting and dispositive power with respect to these
securities is exercised by Mary Schaheen, the Chairman of Numoda Capital
Innovations, LLC and the chief executive officer of the Numoda
Corporation. For a description of our relationship with the
Numoda Corporation, please see, “Description of Business — Partnerships
and Agreements — Numoda
Corporation.”
|
(4)
|
Consists
of warrants to purchase 2,818,000 shares of our common
stock. The sole stockholder of the holder is Optimus Capital
Partners, LLC, d/b/a Optimus Life Sciences Capital Partners, LLC. Voting
and dispositive power with respect to these securities is exercised by
Terry Peizer, the Managing Director of Optimus Life Sciences Capital
Partners, LLC, who acts as investment advisor to the holder. The holder is
not a registered broker-dealer or an affiliate of a registered
broker-dealer. On July 19, 2010, we issued to Optimus
CG II, Ltd., pursuant to the Series B purchase agreement, a
three-year warrant to purchase up to 40,500,000 shares of our common
stock, at an initial exercise price of $0.25 per share, subject to
adjustment as provided elsewhere in this prospectus. The warrant will
become exercisable upon the effectiveness of the registration statement of
which this prospectus forms a part. For a description of our
relationship with Optimus, please see, “Management’s Discussion and
Analysis and Results of Operations — Liquidity and Capital Resources,”
“Description of Our Capital Stock — Preferred Stock” and “Description of
Our Capital Stock — Warrants.”
|
|
·
|
senior
to our common stock and any other class or series of preferred stock
(other than Series A preferred stock or any class or series of preferred
stock that we intend to cause to be listed for trading or quoted on
Nasdaq, NYSE Amex or the New York Stock
Exchange);
|
|
·
|
pari passu with any
outstanding shares of our Series A preferred stock (none of which are
issued and outstanding as of the date hereof);
and
|
|
·
|
junior
to all of our existing and future indebtedness and any class or series of
preferred stock that we intend to cause to be listed for trading or quoted
on Nasdaq, NYSE Amex or the New York Stock
Exchange.
|
|
·
|
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 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 warrant shares or (ii) all warrant shares 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 our company since
the date of the Series B purchase agreement, other than losses incurred in
the ordinary course of business;
|
|
·
|
we
must not be in default under any material
agreement;
|
|
·
|
certain
lock-up agreements 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 Series B purchase agreement;
and
|
|
·
|
the
aggregate of all shares of our common stock beneficially owned by Optimus
and its affiliates must not exceed 9.99% of our outstanding common
stock.
|
|
·
|
1%
of the number of shares of our common stock then outstanding, which
equaled 1,705,858 shares as of July 1, 2010,
or
|
|
·
|
the
average weekly trading volume of our common stock on the OTC Bulletin
Board during the four calendar weeks preceding the filing of a notice on
Form 144 with respect to that sale.
|
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
|
·
|
broker-dealers
may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per
share;
|
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
|
·
|
a
combination of any such methods of sale;
or
|
|
·
|
any
other method permitted pursuant to applicable
law.
|
Page
|
|
Audited
Financial Statements
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Report
of Independent Registered Public Accounting Firm
|
F-3
|
Balance
Sheets as of October 31, 2009 and 2008
|
F-4
|
Statements
of Operations for the years ended October 31, 2009 and 2008 and the period
from March 1, 2002 (Inception) to October 31, 2009
|
F-5
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to October 31, 2009
|
F-6
|
Statements
of Cash Flows for the years ended October 31, 2009 and 2008 and the period
from March 1, 2002 (Inception) to October 31, 2009
|
F-7
|
Notes
to Financial Statements
|
F-9
|
Unaudited
Interim Financial Statements
|
|
Balance
Sheets as of April 30, 2010 (unaudited) and October 31,
2009
|
F-30
|
Statements
of Operations for the three and six month periods ended April 30, 2010 and
2009 and the period from March 1, 2002 (Inception) to April 30, 2010
(unaudited)
|
F-31
|
Statements
of Cash Flow for the six month periods ended April 30, 2010 and 2009 and
the period from March 1, 2002 (Inception) to April 30, 2010
(unaudited)
|
F-32
|
Supplemental
Schedule of Noncash Investing and Financing Schedules
|
F-33
|
Notes
to Unaudited Financial Statements
|
F-34
|
October 31,
2009
|
October 31,
2008
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 659,822 | $ | 59,738 | ||||
Prepaid
expenses
|
36,445 | 38,862 | ||||||
Total
Current Assets
|
696,267 | 98,600 | ||||||
Deferred
expenses
|
288,544 | — | ||||||
Property
and Equipment (net of accumulated depreciation)
|
54,499 | 91,147 | ||||||
Intangible
Assets (net of accumulated amortization)
|
1,371,638 | 1,137,397 | ||||||
Deferred
Financing Cost
|
299,493 | |||||||
Other
Assets
|
3,876 | 3,876 | ||||||
TOTAL
ASSETS
|
$ | 2,714,317 | $ | 1,331,020 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 2,368,716 | $ | 998,856 | ||||
Accrued
expenses
|
917,250 | 603,345 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
2,078,851 | — | ||||||
Notes
payable – current portion, including interest payable
|
1,121,094 | 563,317 | ||||||
Total
Current Liabilities
|
6,485,911 | 2,165,518 | ||||||
Common
Stock Warrant
|
11,961,734 | — | ||||||
Notes
payable - net of current portion
|
— | 4,813 | ||||||
Total
Liabilities
|
$ | 18,447,645 | $ | 2,170,331 | ||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and
outstanding
|
— | — | ||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 115,638,243 in 2009 and 109,319,520 in 2008
|
115,638 | 109,319 | ||||||
Additional
Paid-In Capital
|
754,834 | 16,584,414 | ||||||
Deficit
accumulated during the development stage
|
(16,603,800 | ) | (17,533,044 | ) | ||||
Total
Shareholders' Deficiency
|
(15,733,328 | ) | (839,311 | ) | ||||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$ | 2,714,317 | $ | 1,331,020 |
Year Ended
October 31,
|
Year Ended
October 31,
|
Period from
March 1, 2002
(Inception) to
October 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Revenue
|
$ | 29,690 | $ | 65,736 | $ | 1,354,862 | ||||||
Research
& Development Expenses
|
2,315,557 | 2,481,840 | 10,173,541 | |||||||||
General
& Administrative Expenses
|
2,701,133 | 3,035,680 | 12,709,700 | |||||||||
Total
Operating expenses
|
5,016,690 | 5,517,520 | 22,883,243 | |||||||||
Loss
from Operations
|
(4,987,000 | ) | (5,451,784 | ) | (21,528,379 | ) | ||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(851,008 | ) | (11,263 | ) | (1,935,491 | ) | ||||||
Other
Income
|
46,629 | 246,457 | ||||||||||
Gain
on note retirement
|
— | — | 1,532,477 | |||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
5,845,229 | — | 4,202,997 | |||||||||
Net
Income/( Loss) before income tax benefit
|
7,221 | (5,416,418 | ) | (17,481,939 | ) | |||||||
Income
Tax Benefit
|
922,023 | — | 922,023 | |||||||||
Net
Income/( Loss)
|
929,244 | (5,416,418 | ) | (16,559,916 | ) | |||||||
Dividends
attributable to preferred shares
|
— | — | 43,884 | |||||||||
Net
Income/( Loss) applicable to Common Stock
|
$ | 929,244 | $ | (5,416,418 | ) | $ | (16,603,800 | ) | ||||
Net
Income/(Loss) per share, basic
|
$ | 0.01 | $ | (0.05 | ) | |||||||
Net
Income/(Loss) per share, diluted
|
$ | 0.01 | (0.05 | ) | ||||||||
Weighted
average number of shares outstanding, basic
|
113,365,584 | 108,715,875 | ||||||||||
Weighted
average number of shares outstanding, diluted
|
118,264,246 | 108,715,875 |
Preferred Stock
|
Common Stock
|
Deficit
|
||||||||||||||||||||||||||
Number of
Shares of
Outstanding
|
Amount
|
Number of shares
of outstanding
|
Amount
|
Additional Paid-in Capital
|
Accumulated
During the
Development Stage
|
Shareholders’
Equity (Deficiency)
|
||||||||||||||||||||||
Preferred
stock issued
|
3,418
|
$
|
235,000
|
$
|
235,000
|
|||||||||||||||||||||||
Common
Stock Issued
|
40,000
|
$
|
40
|
$
|
(40
|
)
|
||||||||||||||||||||||
Options
granted to consultants & professionals
|
10,493
|
$
|
10,493
|
|||||||||||||||||||||||||
Net
Loss
|
(166,936
|
)
|
$
|
(166,936
|
)
|
|||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(3,481
|
)
|
(235,000
|
)
|
15,557,723
|
15,558
|
219,442
|
|||||||||||||||||||||
Balance
at December 31, 2002
|
15,597,723
|
$
|
15,598
|
$
|
229,895
|
$
|
(166,936
|
)
|
$
|
78,557
|
||||||||||||||||||
Note
payable converted into preferred stock
|
232
|
15,969
|
$
|
15,969
|
||||||||||||||||||||||||
Options
granted to consultants and professionals
|
8,484
|
$
|
8,484
|
|||||||||||||||||||||||||
Net
loss
|
(909,745
|
)
|
$
|
(909,745
|
)
|
|||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(232
|
)
|
(15,969
|
)
|
15,969
|
|||||||||||||||||||||||
Balance
at December 31, 2003
|
15,597,723
|
$
|
15,598
|
$
|
254,348
|
$
|
(1,076,681
|
)
|
$
|
(806,735
|
)
|
|||||||||||||||||
Stock
dividend on preferred stock
|
638
|
43,884
|
(43,884
|
)
|
||||||||||||||||||||||||
Net
loss
|
(538,076
|
)
|
$
|
(538,076
|
)
|
|||||||||||||||||||||||
Options
granted to consultants and professionals
|
5,315
|
5,315
|
||||||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(638
|
)
|
(43,884
|
)
|
43,884
|
|||||||||||||||||||||||
Balance
at October 31, 2004
|
15,597,723
|
$
|
15,598
|
$
|
303,547
|
$
|
(1,658,641
|
)
|
$
|
(1,339,496
|
)
|
|||||||||||||||||
Common
Stock issued to Placement Agent on re-capitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||||||||
Effect
of re-capitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||||||||
Options
granted to consultants and professionals
|
64,924
|
64,924
|
||||||||||||||||||||||||||
Conversion
of Note payable to Common Stock
|
2,136,441
|
2,136
|
611,022
|
613,158
|
||||||||||||||||||||||||
Issuance
of Common Stock for cash, net of shares to Placement Agent
|
17,450,693
|
17,451
|
4,335,549
|
4,353,000
|
||||||||||||||||||||||||
Issuance
of common stock to consultants
|
586,970
|
587
|
166,190
|
166,777
|
||||||||||||||||||||||||
Issuance
of common stock in connection with the registration
statement
|
409,401
|
408
|
117,090
|
117,498
|
||||||||||||||||||||||||
Issuance
costs
|
(329,673
|
)
|
(329,673
|
)
|
||||||||||||||||||||||||
Net
loss
|
(1,805,789
|
)
|
(1,805,789
|
)
|
||||||||||||||||||||||||
Restatement
to reflect re- capitalization on Nov. 12, 2004 including cash paid of
$44,940
|
(88,824
|
)
|
(88,824
|
)
|
||||||||||||||||||||||||
Balance
at October 31, 2005
|
37,686,428
|
$
|
37,686
|
$
|
5,178,319
|
$
|
(3,464,430
|
)
|
$
|
1,751,575
|
||||||||||||||||||
Options
granted to consultants and professionals
|
172,831
|
172,831
|
||||||||||||||||||||||||||
Options
granted to employees and directors
|
71,667
|
71,667
|
||||||||||||||||||||||||||
Conversion
of debenture to Common Stock
|
1,766,902
|
1,767
|
298,233
|
300,000
|
||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
229,422
|
229
|
54,629
|
54,858
|
||||||||||||||||||||||||
Issuance
of common stock to consultants
|
556,240
|
557
|
139,114
|
139,674
|
||||||||||||||||||||||||
Net
loss
|
(6,197,744
|
)
|
(6,197,744
|
)
|
||||||||||||||||||||||||
Balance
at October 31, 2006
|
40,238,992
|
40,239
|
5,914,793
|
(9,662,173
|
)
|
(3,707,141
|
)
|
|||||||||||||||||||||
Common
Stock issued
|
59,228,334
|
59,228
|
9,321,674
|
9,380,902
|
||||||||||||||||||||||||
Offering
Expenses
|
(2,243,535
|
)
|
(2,243,535
|
)
|
||||||||||||||||||||||||
Options
granted to consultants and professionals
|
268,577
|
268,577
|
||||||||||||||||||||||||||
Options
granted to employees and directors
|
222,501
|
222,501
|
||||||||||||||||||||||||||
Conversion
of debenture to Common Stock
|
6,974,202
|
6,974
|
993,026
|
1,000,010
|
||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
416,448
|
416
|
73,384
|
73,800
|
||||||||||||||||||||||||
Issuance
of common stock to consultants
|
1,100,001
|
1,100
|
220,678
|
221,778
|
||||||||||||||||||||||||
Warrants
issued on conjunction with issuance of common stock
|
1,505,550
|
1,505,550
|
||||||||||||||||||||||||||
Net
loss
|
(2,454,453
|
)
|
(2,454,453
|
)
|
||||||||||||||||||||||||
Balance
at October 31, 2007
|
107,957,977
|
$
|
107,957
|
$
|
16,276,648
|
$
|
(12,116,626
|
)
|
$
|
4,267,979
|
||||||||||||||||||
Common
Stock Penalty Shares
|
211,853
|
212
|
31,566
|
—
|
31,778
|
|||||||||||||||||||||||
Offering
Expenses
|
(78,013
|
)
|
(78,013
|
)
|
||||||||||||||||||||||||
Options
granted to consultants and professionals
|
(42,306
|
)
|
(42,306
|
)
|
||||||||||||||||||||||||
Options
granted to employees and directors
|
257,854
|
257,854
|
||||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
995,844
|
996
|
85,005
|
86,001
|
||||||||||||||||||||||||
Issuance
of common stock to consultants
|
153,846
|
154
|
14,462
|
14,616
|
||||||||||||||||||||||||
Warrants
issued to consultant
|
39,198
|
39,198
|
||||||||||||||||||||||||||
Net
loss
|
(5,416,418
|
)
|
(5,416,418
|
)
|
||||||||||||||||||||||||
Balance
at October 31, 2008
|
109,319,520
|
$
|
109,319
|
$
|
16,584,414
|
$
|
(17,533,044
|
)
|
$
|
(839,311
|
)
|
|||||||||||||||||
Common
stock issued upon exercise of warrants
|
3,299,999
|
3,300
|
(3,300
|
)
|
0
|
|||||||||||||||||||||||
Warrants
classified as a liability
|
(12,785,695
|
)
|
(12,785,695
|
)
|
||||||||||||||||||||||||
Issuance
of common Stock Warrants
|
(3,587,625
|
) |
(3,587,625)
|
|||||||||||||||||||||||||
Options
granted to professionals and consultants
|
12,596
|
12,596
|
||||||||||||||||||||||||||
Options
granted to employees and directors
|
0
|
467,304
|
467,304
|
|||||||||||||||||||||||||
Issuance
of common stock to employees and directors
|
422,780
|
423
|
17,757
|
18,180
|
||||||||||||||||||||||||
Issuance
of common stock to consultants
|
2,595,944
|
2,596
|
49,383
|
51,979
|
||||||||||||||||||||||||
Net
Income/ (Loss)
|
|
|
929,244
|
929,244
|
||||||||||||||||||||||||
Balance
at October 31, 2009
|
115,638,243
|
$
|
115,638
|
$
|
754,834
|
$
|
(16,603,800
|
)
|
$
|
(15,733,328
|
)
|
|
Period from
|
|||||||||||
March 1
|
||||||||||||
2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
Income (Loss)
|
$
|
929,244
|
$
|
(5,416,418
|
)
|
$
|
(16,559,916
|
)
|
||||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
|
|||||||||||
Non-cash
charges to consultants and employees for options and stock
|
571,525
|
355,364
|
2,424,755
|
|||||||||
Amortization
of deferred financing costs
|
—
|
—
|
260,000
|
|||||||||
Amortization of deferred expenses | 61,456 |
—
|
61,456 | |||||||||
Amortization
of discount on Bridge Loans
|
123,846
|
123,846
|
|
|||||||||
Non-cash
interest expense
|
698,650
|
7,907
|
1,216,835
|
|||||||||
(Gain)
Loss on change in value of warrants and embedded
derivative
|
(5,845,229
|
)
|
—
|
(4,202,997
|
) | |||||||
Value
of penalty shares issued
|
—
|
31,778
|
149,276
|
|||||||||
Depreciation
expense
|
36,648
|
36,137
|
128,738
|
|||||||||
Amortization
expense of intangibles
|
74,508
|
161,208
|
388,019
|
|||||||||
Gain
on note retirement
|
—
|
—
|
(1,532,477
|
)
|
||||||||
(Increase)
decrease in prepaid expenses
|
2,417
|
161,055
|
(36,445
|
)
|
||||||||
Decrease
(increase) in other assets
|
—
|
—
|
(3,876
|
)
|
||||||||
Increase
in accounts payable
|
1,421,838
|
211,559
|
2,857,900
|
|||||||||
(Decrease)
increase in accrued expenses
|
(109,540
|
)
|
298,322
|
477,618
|
||||||||
(Decrease)
increase in interest payable
|
—
|
—
|
18,291
|
|||||||||
Net
cash used in operating activities
|
(2,034,636
|
)
|
(4,153,088
|
)
|
(14,228,977
|
)
|
||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
—
|
—
|
(44,940
|
)
|
||||||||
Purchase
of property and equipment
|
—
|
(10,842
|
)
|
(137,657
|
)
|
|||||||
Cost
of intangible assets
|
(308,749
|
)
|
(200,470
|
)
|
(1,834,609
|
)
|
||||||
Net
cash used in Investing Activities
|
(308,749
|
)
|
(211,312
|
)
|
(2,017,206
|
)
|
||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from (repayment of) convertible secured debenture
|
—
|
—
|
960,000
|
|||||||||
Cash
paid for deferred financing costs
|
(299,493
|
)
|
—
|
(559,493
|
)
|
|||||||
Proceeds
from notes payable
|
3,259,635
|
475,000
|
5,005,860
|
|||||||||
Payment
on notes payable
|
(16,672
|
)
|
(14,832
|
)
|
(123,591
|
)
|
||||||
Net
proceeds of issuance of Preferred Stock
|
—
|
—
|
235,000
|
|||||||||
Payment
on cancellation of Warrants
|
—
|
—
|
(600,000
|
)
|
||||||||
Net
proceeds of issuance of Common Stock
|
—
|
(78,014
|
)
|
11,988,230
|
||||||||
Net
cash provided by Financing Activities
|
2,943,469
|
382,154
|
16,906,005
|
|||||||||
Net
increase in cash
|
600,084
|
(3,982,246
|
)
|
659,822
|
||||||||
Cash
at beginning of period
|
59,738
|
4,041,984
|
—
|
|||||||||
Cash
at end of period
|
$
|
659,822
|
$
|
59,738
|
$
|
659,822
|
Period from
|
||||||||||||
March 1, 2002
|
||||||||||||
Year ended
|
Year ended
|
(Inception) to
|
||||||||||
October 31,
|
October 31,
|
October 31,
|
||||||||||
2009
|
2008
|
2008
|
||||||||||
Equipment
acquired under notes payable
|
$
|
$
|
—
|
$
|
45,580
|
|||||||
Common
Stock issued to Founders
|
$
|
$
|
—
|
$
|
40
|
|||||||
Notes
payable and accrued interest converted to Preferred Stock
|
$
|
$
|
—
|
$
|
15,969
|
|||||||
Stock
dividend on Preferred Stock
|
$
|
$
|
—
|
$
|
43,884
|
|||||||
Accounts
payable from consultants settled with common stock
|
51,978
|
—
|
51,978
|
|||||||||
Notes
payable and accrued interest converted to Common
Stock
|
$
|
$
|
—
|
$
|
2,513,158
|
|||||||
Intangible
assets acquired with notes payable
|
$
|
$
|
—
|
$
|
360,000
|
|||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$
|
1,579,646
|
$
|
—
|
$
|
2,082,442
|
||||||
Allocation
of the original secured convertible debentures to warrants
|
$
|
$
|
—
|
$
|
214,950
|
|||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$
|
940,511
|
—
|
$
|
940,511
|
|||||||
Warrants
issued in connection with issuance of Common Stock
|
$
|
$
|
—
|
$
|
1,505,550
|
|||||||
Warrants
issued in connection with issuance of Preferred Stock
|
$
|
3,587,625
|
$
|
—
|
$
|
3,587,625
|
1.
|
PRINCIPAL BUSINESS ACTIVITY AND
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES:
|
October 31, 2009
|
October 31, 2008
|
|||||||
Warrants
|
127,456,301 | 97,187,400 | ||||||
Stock
Options
|
7,881,591 | 8,812,841 | ||||||
Convertible Debt (using the if-converted method) | 49,749,280 | — | ||||||
Total
|
185,087,172 | 106,000,241 |
March 1, 2002
(date of
inception) to
October 31,
2009
|
||||
Net
Loss as reported
|
$
|
(16,559,916
|
)
|
|
Add:
Stock based option expense included in recorded net loss
|
89,217
|
|||
Deduct
stock option compensation expense determined under fair value based
method
|
(328,176
|
)
|
||
Adjusted
Net Loss
|
$
|
(16,798,875
|
)
|
Year Ended
|
Year Ended
|
|||||||
October 31,
2009
|
October 31,
2008
|
|||||||
Expected
volatility
|
170.2
|
%
|
110.1
|
%
|
||||
Expected
Life
|
6.0
years
|
5.9
years
|
||||||
Dividend
yield
|
0
|
0
|
||||||
Risk-free
interest rate
|
3.5
|
%
|
3.6
|
%
|
Warrants
Outstanding – October 31, 2008
|
97,187,400 | |||
Issued
New Warrants
|
40,716,625 | |||
Exercised
|
-3,333,333 | |||
Change
in Ratchet Calculation
|
-7,114,391 | |||
Warrants
Outstanding – October 31, 2009
|
127,456,301 | |||
October 31,
2009
|
October
31,
2008
|
|||||||
License
|
$
|
571,275
|
$
|
$529,915
|
||||
Patents
|
1,080,299
|
812,910
|
||||||
Total
intangibles
|
1,651,574
|
1,342,825
|
||||||
Accumulated
Amortization and impairments
|
279,936
|
205,428
|
||||||
Intangible
Assets
|
$
|
1,371,638
|
$
|
1,137,397
|
October 31,
2009
|
October 31,
2008
|
|||||||
Salaries
and other compensation
|
$ | 768,552 | $ | 430,256 | ||||
Sponsored
Research Agreement
|
119,698 | 119,698 | ||||||
Consultants
|
29,000 | 24,000 | ||||||
Warrants
|
— | 16,340 | ||||||
Clinical
Research Organization
|
— | 11,166 | ||||||
Other
|
— | 1,885 | ||||||
$ | 917,250 | $ | 603,345 |
Description
|
Principal
|
Purchase
Price
|
Original Issue
Discount
|
Maturity Date
|
||||||||||
Tranche
I-June 18, 2009
|
$ | 1,131,353 | $ | 961,650 | $ | 169,703 |
December
31, 2009
|
|||||||
Tranche
II-October 26, 2009
|
1,617,647 | 1,375,000 | 242,647 |
April
30, 2010
|
||||||||||
Tranche
III-October 30, 2009
|
529,412 | 450,000 | 79,412 |
April
30, 2010
|
||||||||||
Total
Bridge Notes
|
$ | 3,278,412 | $ | 2,786,650 | $ | 491,762 |
Bridge
Notes – Principal Value
|
$ | 3,278,412 | ||
Original
Issue Discount, net of accreted interest
|
(367,916 | ) | ||
Fair
Value of Attached Warrants at issuance
|
(940,512 | ) | ||
Fair
Value of Embedded Derivatives at issuance
|
(1,579,646 | ) | ||
Accreted
interest on embedded derivative and warrant liabilities
|
601,999 | |||
Convertible
Bridge Notes- as of October 31, 2009
|
$ | 922,337 | ||
Embedded
Derivatives Liability at October 31, 2009
|
1,086,514 | |||
Convertible Bridge
Notes and fair value of embedded derivative
|
$ | 2,078,851 |
Description
|
Principal
|
Original
Issue
Discount
|
Warrant
Liability
|
Embedded
Derivative
Liability
|
||||||||||||
Bridge
Note I-June 18, 2009
|
$ | 1,131,353 | $ | 169,703 | $ | 250,392 | $ | 711,258 | ||||||||
Bridge
Note II & III-October 26 & 30, 2009
|
2,147,059 | 322,059 | 690,119 | 868,388 | ||||||||||||
Optimus
September 24, 2009
|
— | — | 3,587,625 | — | ||||||||||||
Other
outstanding warrants
|
— | — | 12,785,695 | — | ||||||||||||
Total
Valuation at Origination
|
$ | 3,278,412 | $ | 491,762 | $ | 17,313,831 | $ | 1,579,646 | ||||||||
Change
in fair value
|
— | — | (5,352,697 | ) | (493,132 | ) | ||||||||||
Accreted
interest
|
— | (123,846 | ) | — | — | |||||||||||
Total
Valuation as of October 31, 2009
|
$ | 3,278,412 | $ | 367,916 | $ | 11,961,734 | $ | 1,086,514 |
(i)
|
$0.20
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 319.25%, Life 145 to 1825 days, warrants outstanding
89,143,801.
|
(ii)
|
$0.135
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 319.25%, Life 145 to 1825 days warrants outstanding
123,269,393
|
(iii)
|
$0.055
exercise price, market price $0.11, risk free interest 1.00% to 2.86%,
volatility 170.16% to 191.53%, Life 620 to 1825 days, warrants outstanding
202,416,414
|
(i)
|
$0.20
exercise price, market price $0.13, risk free interest 0.01% to 2.3%,
volatility 89.7% to 211.6%, Life 10 to 1690 days warrants outstanding
86,739,676.
|
(ii)
|
$0.135
exercise price, market price $0.13, risk free interest 0.01% to 2.3%,
volatility 89.7% to 211.6%, Life 10 to 1690 days, warrants outstanding
120,865,268
|
(iii)
|
The
third assumption used at June 18, 2009 is no longer being used
given the events that could have triggered this assumption, in managements
estimation, are no longer probable.
|
·
|
$0.20/share
at a 50% conversion divided into $1,131,353 equals 11,313,530 shares plus
warrant & share dilution (1).
|
·
|
$0.10/share
at a 50% conversion divided into $1,131,353 equals 22,627,060 shares plus
warrant & share dilution (1).
|
·
|
$0.05/share
at a 50% conversion divided into $1,131,353 or 45,254,120 shares plus
warrant and share dilution (1).
|
·
|
$0.01/share
at a 50% conversion divided into $1,131,353 or 226,270,600 shares plus
warrant and share dilution (1).
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Life In
Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding
as of October 31, 2007
|
8,512,841 | $ | 0.22 | 7.8 | 167,572 | |||||||||||
Granted
|
300,000 | $ | 0.09 | — | — | |||||||||||
Cancelled
or Expired
|
— | $ | — | — | ||||||||||||
Outstanding
as of October 31, 2008
|
8,812,841 | $ | 0.22 | 6.3 | 167,572 | |||||||||||
Granted
|
10,150,000 | $ | 0.10 | 9.8 | 294,500 | |||||||||||
Exercised
|
— | — | — | — | ||||||||||||
Cancelled
or Expired
|
(631,250 | ) | 0.13 | 7.5 | (15,000 | ) | ||||||||||
Outstanding
as of October 31, 2009
|
18,331,591 | 0.16 | 6.0 | $ | 306,500 | |||||||||||
Vested
& Exercisable at October 31, 2009
|
11,611,174 | $ | 0.18 | 6.0 | $ | 102,667 |
|
Options Outstanding
|
Options Exercisable
|
||||||||||||||||||||||||||||
Range of
Exercise
Prices
|
Number
Outstanding
(000’s)
|
Weighted-
Average
Remaining
Contractual
Life (in Years)
|
Weighted-
Average
Exercise
Price per
Share
|
Aggregate
Intrinsic
Value
|
Number
Exercisable
(000’s)
|
Weighted-
Average
Exercise
Price per
Share
|
Aggregate
Intrinsic
Value
|
|||||||||||||||||||||||
$ | 0.09-0.11 | 9,950 | 9.3 | 0.10 | $ | 306,500 | 3,496 | $ | 0.10 | $ | 102,667 | |||||||||||||||||||
0.14-0.17 | 3,115 | 6.2 | $ | 0.15 | 0 | 2,906 | 0.15 | 0 | ||||||||||||||||||||||
0.18-0.21 | 1,739 | 4.0 | 0.21 | 0 | 1,720 | 0.21 | 0 | |||||||||||||||||||||||
0.22-0.25 | 296 | 4.3 | 0.24 | 0 | 213 | 0.24 | 0 | |||||||||||||||||||||||
0.26-0.29 | 2,992 | 5.1 | 0.28 | 0 | 2,954 | 0.28 | 0 | |||||||||||||||||||||||
0.30-0.43 | 322 | 3.3 | 0.37 | 322 | 0.37 | 0 | ||||||||||||||||||||||||
Total
|
18,332 | 6.0 | $ | 0.16 | $ | 306,500 | 11,611 | $ | 0.18 | $ | 102,667 |
A summary of the status of the Company’s nonvested shares as
of October 31, 2007, and changes during the years ended
|
Number of
Shares
|
Weighted
Average
Exercise
Price at
Grant
Date
|
Weighted Average
Remaining
Contractual Term
(in years)
|
|||||||||
Non-vested
shares at October 31, 2007
|
3,080,305
|
$
|
0.19
|
8.5
|
||||||||
Options
granted
|
300,000
|
$
|
0.09
|
9.4
|
||||||||
Options
vested
|
(1,967,027
|
)
|
$
|
0.18
|
7.5
|
|||||||
Non-vested
shares at October 31, 2008
|
1,413,278
|
$
|
0.18
|
7.5
|
||||||||
Options
granted
|
6,766,667
|
$
|
0.10
|
9.3
|
||||||||
Options
vested
|
(1,459,528
|
)
|
$
|
0.19
|
6.0
|
|||||||
Non-vested
shares at October 31, 2009
|
6,720,417
|
$
|
0.10
|
8.7
|
2009
|
2008
|
|||||||
Net
operating loss carryforwards-federal
|
$
|
7,786,507
|
6,452,027
|
|||||
Stock
based compensation
|
990,700
|
217,334
|
||||||
Research
and development tax credits
|
216,134
|
|||||||
Less
valuation allowance
|
(8,993,341
|
)
|
(6,669,360
|
)
|
||||
Deferred
tax asset
|
$
|
—
|
$
|
—
|
Year ended
October 31,
2009
|
Year ended
October 31,
2008
|
Period from
March 1, 2002
(inception) to
October 31,
2009
|
||||||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
||||||
—
|
%
|
—
|
%
|
—
|
%
|
April 30,
2010
|
October 31,
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 227,245 | $ | 659,822 | ||||
Prepaid
expenses
|
65,003 | 36,445 | ||||||
Total
Current Assets
|
292,248 | 696,267 | ||||||
Deferred
expenses
|
206,528 | 288,544 | ||||||
Property
and Equipment (net of accumulated depreciation)
|
45,439 | 54,499 | ||||||
Intangible
Assets (net of accumulated amortization)
|
1,486,336 | 1,371,638 | ||||||
Deferred
Financing Cost
|
- | 299,493 | ||||||
Other
Assets
|
20,685 | 3,876 | ||||||
Total
Assets
|
$ | 2,051,236 | $ | 2,714,317 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 1,782,895 | $ | 2,368,716 | ||||
Accrued
expenses
|
748,492 | 917,250 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
4,073,716 | 2,078,851 | ||||||
Notes
payable – including interest payable
|
940,653 | 1,121,094 | ||||||
Total
Current Liabilities
|
7,545,756 | 6,485,911 | ||||||
Common
Stock Warrant
|
16,467,800 | 11,961,734 | ||||||
Total
Liabilities
|
$ | 24,013,556 | $ | 18,447,645 | ||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; issued and
outstanding 361 at April 30, 2010 and 0 at October 31,
2009
|
||||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 142,781,243 at April 30, 2010 and 115,638,243 at October 31,
2009
|
142,780 | 115,638 | ||||||
Additional
Paid-In Capital
|
12,572,129 | 754,834 | ||||||
Stock
subscription receivable
|
(4,881,710 | ) | - | |||||
Deficit
accumulated during the development stage
|
(29,795,519 | ) | (16,603,800 | ) | ||||
Total
Shareholders' Deficiency
|
$ | (21,962,320 | ) | $ | (15,733,328 | ) | ||
Total
Liabilities and stockholders’ deficiency
|
$ | 2,051,236 | $ | 2,714,317 |
Three Months Ended
April 30,
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to
April 30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Revenue
|
$
|
87,234
|
$
|
$
|
87,234
|
$
|
$
|
1,442,096
|
||||||||||||
Research
& Development Expenses
|
1,084,703
|
283,812
|
2,082,038
|
462,986
|
12,255,579
|
|||||||||||||||
General
& Administrative Expenses
|
779,463
|
488,468
|
1,368,478
|
1,033,922
|
14,078,178
|
|||||||||||||||
Total
Operating expenses
|
1,864,166
|
772,280
|
3,450,516
|
1,496,908
|
26,333,757
|
|||||||||||||||
Loss
from Operations
|
(1,776,932
|
)
|
(772,280
|
)
|
(3,363,282
|
)
|
(1,496,908
|
)
|
(24,891,661
|
)
|
||||||||||
Other
Income (expense):
|
||||||||||||||||||||
Interest
expense
|
(1,647,069
|
)
|
(20,658
|
)
|
(3,313,208
|
)
|
(36,052
|
)
|
(5,248,699
|
)
|
||||||||||
Other
Income
|
14,539
|
-
|
16,810
|
-
|
263,267
|
|||||||||||||||
Gain
on note retirement
|
64,354
|
-
|
64,354
|
-
|
1,596,831
|
|||||||||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
(5,785,257
|
)
|
-
|
(6,875,371
|
)
|
-
|
(2,672,374
|
)
|
||||||||||||
Net
(Loss) before benefit for income taxes
|
(9,130,365
|
)
|
(792,938
|
)
|
(13,470,697
|
)
|
(1,532,960
|
)
|
(30,952,636
|
)
|
||||||||||
Income
tax benefit
|
-
|
-
|
278,978
|
922,020
|
1,201,001
|
|||||||||||||||
Net
(Loss)
|
(9,130,365
|
)
|
(792,938
|
)
|
(13,191,719
|
)
|
(610,940
|
)
|
(29,751,635
|
)
|
||||||||||
Dividends
attributable to preferred shares
|
-
|
-
|
-
|
-
|
(43,884
|
)
|
||||||||||||||
Net
(Loss) applicable to Common Stock
|
$
|
(9,130,365
|
)
|
$
|
(792,938
|
)
|
$
|
(13,191,719
|
)
|
$
|
(610,940
|
)
|
$
|
(29,795,519
|
)
|
|||||
Net
(Loss) per share, basic
|
$
|
(.07
|
)
|
$
|
(0.01
|
)
|
$
|
(.11
|
)
|
$
|
(0.01
|
)
|
||||||||
Net
(Loss) per share, diluted
|
$
|
(.07
|
)
|
$
|
(0.01
|
)
|
$
|
(.11
|
)
|
$
|
(0.01
|
)
|
||||||||
Weighted
average number of shares outstanding, basic
|
133,124,164
|
112,319,454
|
125,577,856
|
111,255,809
|
||||||||||||||||
Weighted
average number of shares, diluted
|
133,124,164
|
112,319,454
|
125,577,856
|
111,255,809
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to
April 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$
|
(13,191,719
|
)
|
$
|
(610,940
|
)
|
$
|
(29,751,635
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in
|
||||||||||||
operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and
stock
|
268,696
|
94,943
|
2,693,451
|
|||||||||
Amortization
of deferred financing costs
|
-
|
-
|
260,000
|
|||||||||
Amortization
of deferred expenses
|
82,016
|
-
|
143,472
|
|||||||||
Amortization
of discount on Bridge Loans
|
480,730
|
604,576
|
||||||||||
Impairment
of intangible assets
|
-
|
26,087
|
||||||||||
Non-cash
interest expense
|
2,818,711
|
31,676
|
4,035,547
|
|||||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
6,875,371
|
-
|
2,672,374
|
|||||||||
Value
of penalty shares issued
|
-
|
-
|
149,276
|
|||||||||
Depreciation
expense
|
19,075
|
18,324
|
147,813
|
|||||||||
Amortization
expense of intangibles
|
43,522
|
35,434
|
405,454
|
|||||||||
Gain
on note retirement
|
(64,354
|
)
|
(1,596,831
|
)
|
||||||||
Decrease
(Increase) in prepaid expenses
|
(28,558
|
) |
(13,520
|
)
|
(65,002
|
)
|
||||||
Increase
in other assets
|
(14,538
|
)
|
-
|
(18,415
|
)
|
|||||||
(Decrease)
increase in accounts payable
|
(460,987
|
)
|
107,250
|
2,396,912
|
||||||||
(Decrease)
Increase in accrued expenses
|
(168,758
|
)
|
(18,825
|
308,860
|
||||||||
(Decrease)
in interest payable
|
(161,200
|
)
|
-
|
(142,909
|
)
|
|||||||
Net
cash used in operating activities
|
(3,501,993
|
)
|
(355,658
|
)
|
(17,730,970
|
)
|
||||||
INVESTING ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
(44,940
|
)
|
|||||||||
Purchase
of property and equipment
|
(10,014
|
)
|
-
|
(147,671
|
)
|
|||||||
Cost
of intangible assets
|
(158,220
|
)
|
(117,764
|
)
|
(1,992,829
|
)
|
||||||
Net
cash used in Investing Activities
|
(168,234
|
)
|
(117,764
|
)
|
(2,185,440
|
)
|
||||||
FINANCING ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
-
|
960,000
|
||||||||||
Cash
paid for deferred financing costs
|
-
|
-
|
(559,493
|
)
|
||||||||
Principal
payment on notes payable
|
(1,150,177
|
)
|
(4,813
|
)
|
(1,273,768
|
)
|
||||||
Proceeds
from notes payable
|
1,015,000
|
-
|
6,020,859
|
|||||||||
Payment
on notes payable
|
-
|
449,985
|
||||||||||
Net
proceeds of issuance of Preferred Stock
|
3,202,827
|
-
|
3,437,827
|
|||||||||
Cancellation
of warrants
|
-
|
-
|
(600,000
|
)
|
||||||||
Proceeds
from exercise of warrants
|
170,000
|
170,000
|
||||||||||
Proceeds
from issuance of common stock
|
-
|
-
|
11,988,230
|
|||||||||
Net
cash provided by financing Activities
|
3,237,650
|
445,172
|
20,143,655
|
|||||||||
Net
(Decrease) increase in cash
|
(432,577
|
)
|
(28,250
|
)
|
227,245
|
|||||||
Cash
at beginning of period
|
659,822
|
59,738
|
-
|
|||||||||
Cash
at end of period
|
$
|
227,245
|
$
|
31,488
|
$
|
227,245
|
Six Months Ended
April 30,
|
Period from
March 1, 2002
(Inception) to April
30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
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 | ||||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$ | 539,354 | - | $ | 2,621,796 | |||||||
Allocation
of the original secured convertible debentures to warrants
|
- | - | $ | 214,950 | ||||||||
Allocation
of the warrants on Bridge Notes as debt discount
|
$ | 639,735 | - | $ | 1,580,246 | |||||||
Note
receivable in connection with exercise of warrants
|
$ | 4,881,710 | - | $ | 4,881,710 | |||||||
Warrants
Issued in connection with issuance of Common Stock
|
- | - | $ | 1,505,550 | ||||||||
Warrants
issued in connection with issuances of Preferred stock
|
- | - | $ | 3,587,625 |
As of April 30,
|
||||||||
2010
|
2009
|
|||||||
Warrants
|
85,043,407 | 89,417,733 | ||||||
Stock
Options
|
18,119,090 | 8,812,841 | ||||||
Total
|
103,162,497 | 98,230,574 |
April 30,
2010
|
October 31,
2009
|
|||||||
License
|
$
|
651,992
|
$
|
571,275
|
||||
Patents
|
1,157,802
|
1,080,299
|
||||||
Total
intangibles
|
1,809,794
|
1,651,574
|
||||||
Accumulated
Amortization
|
(323,458
|
)
|
(279,936
|
)
|
||||
Intangible
Assets
|
$
|
1,486,336
|
$
|
1,371,638
|
Bridge
Note – Principal Value - Issued
|
$ |
4,474,601
|
||
Principal
payments on Bridge Notes
|
(1,040,177
|
)
|
||
Original
Issue Discount, net of accreted interest
|
(68,375
|
)
|
||
Fair
Value of Attached Warrants at issuance
|
(1,580,248)
|
|||
Fair
Value of Embedded Derivatives at issuance
|
(2,430,858
|
)
|
||
Accreted
interest on embedded derivative and warrant liabilities
|
3,641,114
|
|||
Convertible
Bridge Notes- as of April 30, 2010
|
$
|
2,996,057
|
||
Embedded
Derivatives Liability at April 30, 2010
|
1,077,659
|
|||
Convertible Bridge
Notes and fair value of embedded derivative
|
$
|
4,073,716
|
Description
|
Principal
|
Original
Issue
Discount
|
Warrant
Liability
|
Embedded
Derivative
Liability
|
||||||||||||
Bridge
Note I-June 18, 2009
|
$
|
1,131,353
|
$
|
169,703
|
$
|
250,392
|
$
|
711,258
|
||||||||
Bridge
Note II & III-October 26 & 30, 2009
|
2,147,059
|
322,059
|
690,119
|
868,388
|
||||||||||||
Optimus
September 24, 2009
|
-
|
-
|
3,587,625
|
-
|
||||||||||||
Other
outstanding warrants
|
-
|
-
|
12,785,695
|
-
|
||||||||||||
Total
Valuation at Origination
|
$
|
3,278,412
|
$
|
491,762
|
$
|
17,313,831
|
$
|
1,579,646
|
||||||||
Change
in fair value
|
-
|
-
|
(5,352,097
|
)
|
(493,132
|
)
|
||||||||||
Accreted
interest
|
-
|
(123,846
|
)
|
-
|
-
|
|||||||||||
Total
Valuation as of October 31, 2009
|
$
|
3,278,412
|
$
|
367,916
|
$
|
11,961,734
|
$
|
1,086,514
|
||||||||
Bridge
Notes IV – December 1, 2009 through January 31, 2010
|
555,882
|
83,382
|
207,617
|
164,400
|
||||||||||||
Bridge
Note I- Extension of Maturity Date
|
202,500
|
103,400
|
||||||||||||||
Change
in fair value
|
1,995,372
|
(905,259)
|
||||||||||||||
Accreted interest
|
(225,321)
|
|||||||||||||||
Exercise
of Common Stock Warrants
|
(1,702,073)
|
|||||||||||||||
Total Valuation
as of January 31, 2010
|
$
|
3,834,294
|
$
|
225,977
|
$
|
12,665,150
|
$
|
449,055
|
||||||||
Bridge
Note V
|
640,307
|
97,807
|
229,619
|
271,554
|
||||||||||||
Change
in fair value
|
5,363,854
|
421,404
|
||||||||||||||
Accreted
interest
|
(251,188
|
)
|
||||||||||||||
Exercise
of common stock warrants
|
(1,790,823
|
)
|
||||||||||||||
Note
Payoffs
|
(1,040,177
|
)
|
(4,222
|
)
|
(64,354
|
)
|
||||||||||
Total
Valuation as of April 30, 2010
|
$
|
3,434,424
|
$
|
68,374
|
$
|
16,467,800
|
$
|
1,077,659
|
As of April 30,
|
||||||||
2010
|
2009
|
|||||||
Research
and development
|
$
|
29,042
|
$
|
31,074
|
||||
General
and Administrative
|
61,225
|
45,692
|
||||||
Total
stock compensation expense recognized
|
$
|
90,267
|
$
|
76,766
|