Delaware
|
2836
|
02-0563870
|
(State
or other jurisdiction
of
incorporation or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
No.)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨ (Do
not check if smaller reporting company)
|
Smaller
reporting company x
|
About
this Prospectus
|
i
|
Prospectus
Summary
|
1
|
The
Offering
|
8
|
Risk
Factors
|
9
|
Special
Note Regarding Forward-Looking Statements
|
23
|
Use
of Proceeds
|
24
|
Market
Price of and Dividends on Our Common Stock and Related Stockholder
Matters
|
24
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
25
|
Description
of Business
|
39
|
Management
|
59
|
Executive
Compensation
|
63
|
Stock
Ownership
|
70
|
Selling
Stockholders
|
72
|
Certain
Relationships and Related Transactions
|
76
|
Description
of Our Capital Stock
|
77
|
Shares
Eligible for Future Sale
|
81
|
Plan
of Distribution
|
83
|
Legal
Matters
|
85
|
Experts
|
85
|
Interests
of Named Experts and Counsel
|
85
|
Where
You Can Find Additional Information
|
85
|
Financial
Statements
|
F-1
|
Product
|
Indication
|
Stage
|
||
ADXS11-001
|
Cervical
Cancer
|
Phase I Company
sponsored & completed in 2007.
|
||
Cervical
Intraepithelial Neoplasia
|
Phase II Company
sponsored study anticipated to commence in January 2010.
|
|||
Cervical
Cancer
|
Phase II Company
sponsored study anticipated to commence in January 2010 in India. 110
Patients with advanced cervical cancer.
|
|||
Cervical
Cancer
|
Phase II The Gynecologic
Oncology Group of the National Cancer Institute may conduct a study
(timing to be determined).
|
|||
ADXS31-142
|
Prostate
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
Breast
Cancer
|
Phase I Company
sponsored (timing to be
determined).
|
|
·
|
senior
to our common stock and any other class or series of preferred stock
(other than a class or series of preferred stock that the we intend to
cause to be listed for trading or quoted on Nasdaq, NYSE Amex or the New
York Stock Exchange); and
|
|
·
|
junior
to all of our existing and future indebtedness and any class or series of
preferred stock that we intend to cause to be listed for trading or quoted
on Nasdaq, NYSE Amex or the New York Stock
Exchange.
|
|
·
|
our
common stock must be listed for trading or quoted on the OTC Bulletin
Board (or another eligible trading market), and we must be in compliance
with all reporting requirements under the Securities Exchange Act of 1934,
as amended, in order to maintain such
listing;
|
|
·
|
either
(i) we have a current, valid and effective registration statement covering
the resale of all shares underlying the warrant or (ii) all shares
underlying the warrant are eligible for resale without limitation under
Rule 144 (assuming cashless exercise of the
warrant);
|
|
·
|
there
must not be any material adverse effect with respect to the company since
the date we executed the Optimus purchase agreement, other than losses
incurred in the ordinary course of
business;
|
|
·
|
we
must not be in default under any material
agreement;
|
|
·
|
ten
trading day lock-up agreements, subject to certain extensions, with
our senior officers and directors and certain beneficial owners of
10% or more of our outstanding common stock must be
effective;
|
|
·
|
there
must not be any legal restraint prohibiting the transactions contemplated
by the Optimus 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.
|
Shares
of common stock offered by us
|
|
None
|
|
Shares
of common stock which may be sold by the selling
stockholders
|
A
total of 80,671,250 shares of our common stock consisting
of:
|
||
·
|
33,750,000
shares of our common stock underlying a warrant issued to an affiliate of
Optimus in our September 2009 preferred equity financing (1);
and
|
||
·
|
46,921,250
shares of our common stock underlying warrants issued in connection with
our October 2007 private placement.
|
||
Use
of proceeds
|
We
will not receive any proceeds from the resale of the shares of common
stock offered by the selling stockholders, as all of
such proceeds will be paid to the selling
stockholders. However, we will receive proceeds from the
exercise of the warrants held by the selling stockholders, if any, to the
extent they are not exercised on a cashless basis. We would receive
proceeds of approximately $16,134,250 from the cash
exercise of such warrants, which we expect we would use for general
corporate and working capital purposes.
|
||
Risk
factors
|
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.
|
||
OTC
Bulletin Board market symbol
|
ADXS.OB
|
(1)
|
These
shares represent 29.2% of our currently outstanding shares of common stock
(based on 115,638,243 shares of common stock outstanding as of October 1,
2009).
|
|
·
|
competition
from companies that have substantially greater assets and financial
resources than we have;
|
|
·
|
need
for acceptance of products;
|
|
·
|
ability
to anticipate and adapt to a competitive market and rapid technological
developments;
|
|
·
|
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
|
|
·
|
need
to rely on multiple levels of complex financing agreements with outside
funding due to the length of the product development cycles and
governmental approved protocols associated with the pharmaceutical
industry; and
|
|
·
|
dependence
upon key personnel including key independent consultants and
advisors.
|
|
·
|
competition
from companies that have substantially greater assets and financial
resources than we have;
|
|
·
|
need
for acceptance of products;
|
|
·
|
ability
to anticipate and adapt to a competitive market and rapid technological
developments;
|
|
·
|
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
|
|
·
|
need
to rely on multiple levels of outside funding due to the length of the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry;
and
|
|
·
|
dependence
upon key personnel including key independent consultants and
advisors.
|
|
·
|
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;
|
|
·
|
Failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by
slow enrollment in clinical studies, length of time to achieve study
endpoints, additional time requirements for data analysis,
or Biologics License Application preparation, discussions with
the FDA, an FDA request for additional preclinical or clinical data, or
unexpected safety or manufacturing
issues;
|
|
·
|
Manufacturing
costs, formulation issues, pricing or reimbursement issues, or other
factors that make the product uneconomical;
and
|
|
·
|
The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
|
·
|
significant
time and effort from our management
team;
|
|
·
|
coordination
of our research and development programs with the research and development
priorities of our collaborators;
and
|
|
·
|
effective
allocation of our resources to multiple
projects.
|
|
·
|
decreased
demand for our product candidates;
|
|
·
|
damage
to our reputation;
|
|
·
|
withdrawal
of clinical trial participants;
|
|
·
|
costs
of related litigation;
|
|
·
|
substantial
monetary awards to patients or other
claimants;
|
|
·
|
loss
of revenues;
|
|
·
|
the
inability to commercialize product candidates;
and
|
|
·
|
increased
difficulty in raising required additional funds in the private and public
capital markets.
|
|
·
|
price
and volume fluctuations in the overall stock market from time to
time;
|
|
·
|
fluctuations
in stock market prices and trading volumes of similar
companies;
|
|
·
|
actual
or anticipated changes in our net loss or fluctuations in our operating
results or in the expectations of securities analysts;
|
·
|
the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock pursuant to the Optimus purchase agreement; |
|
·
|
general
economic conditions and trends;
|
|
·
|
major
catastrophic events;
|
|
·
|
sales
of large blocks of our stock;
|
|
·
|
significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
|
|
·
|
departures
of key personnel;
|
|
·
|
changes
in the regulatory status of our product candidates, including results of
our clinical trials;
|
|
·
|
events
affecting Penn or any future
collaborators;
|
|
·
|
announcements
of new products or technologies, commercial relationships or other events
by us or our competitors;
|
|
·
|
regulatory
developments in the U.S. and other
countries;
|
|
·
|
failure
of our common stock to be listed or quoted on the Nasdaq Stock Market,
NYSE Amex Equities or other national market
system;
|
|
·
|
changes
in accounting principles; and
|
|
·
|
discussion
of us or our stock price by the financial and scientific press and in
online investor communities.
|
|
·
|
Inability
of the accounting professional to keep up with the complex rules resulting
from numerous financial
instruments.
|
|
·
|
with
a price of less than $5.00 per
share;
|
|
·
|
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
|
|
·
|
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.
|
|
·
|
obtain
from the investor information about his or her financial situation,
investment experience and investment
objectives;
|
|
·
|
reasonably
determine, based on that information, that transactions in penny stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions;
|
|
·
|
provide
the investor with a written statement setting forth the basis on which the
broker-dealer made his or her determination;
and
|
|
·
|
receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment
objectives.
|
|
·
|
the
issuance of new equity securities pursuant to a future offering, including
issuances of preferred stock pursuant to the Optimus purchase
agreement;
|
|
·
|
changes
in interest rates;
|
|
·
|
significant
dilution caused by the anti-dilutive clauses in our financial
agreements;
|
|
·
|
competitive
developments, including announcements by competitors of new products or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
|
|
·
|
variations
in quarterly operating results;
|
|
·
|
change
in financial estimates by securities
analysts;
|
|
·
|
the
depth and liquidity of the market for our common
stock;
|
|
·
|
investor
perceptions of our company and the technologies industries generally;
and
|
|
·
|
general
economic and other national
conditions.
|
|
·
|
statements
as to the anticipated timing of clinical studies and other business
developments;
|
|
·
|
statements
as to the development of new
products;
|
|
·
|
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
|
|
·
|
expectations
as to the market opportunities for our products, as well as our ability to
take advantage of those
opportunities.
|
|
·
|
Our
limited operating history and ability to continue as a going
concern;
|
|
·
|
Our
ability to successfully develop and commercialize products based on our
therapies and the Listeria
System;
|
|
·
|
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;
|
|
·
|
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;
|
|
·
|
The
degree and nature of our
competition;
|
|
·
|
Our
ability to employ and retain qualified employees;
and
|
|
·
|
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.”
|
Fiscal 2009
|
Fiscal 2008
|
Fiscal 2007
|
||||||||||||||||||||||
High
|
Low
|
High
|
Low
|
High
|
Low
|
|||||||||||||||||||
First
Quarter (November 1-January 31)
|
$ | 0.06 | $ | 0.01 | $ | 0.20 | $ | 0.13 | $ | 0.21 | $ | 0.14 | ||||||||||||
Second
Quarter (February 1- April 30)
|
$ | 0.05 | $ | 0.02 | $ | 0.15 | $ | 0.09 | $ | 0.54 | $ | 0.15 | ||||||||||||
Third
Quarter (May 1 - July 31)
|
$ | 0.21 | $ | 0.04 | $ | 0.135 | $ | 0.058 | $ | 0.36 | $ | 0.24 | ||||||||||||
Fourth
Quarter (August 1 - October 31)
|
$ | 0.19 |
|
$ | 0.06 |
|
$ | 0.07 | $ | 0.03 | $ | 0.27 | $ | 0.10 |
|
·
|
senior
to our common stock; and
|
|
·
|
junior
to all of our existing and future
indebtedness.
|
|
·
|
Raise
funding to pursue our U.S. based Phase II clinical study of ADXS11-001 in
the therapeutic treatment of CIN and our Indian based Phase II study in
late stage cervical cancer;
|
|
·
|
Continue
to execute our two Phase II clinical studies of ADXS11-001 in the
therapeutic treatment of CIN and late-stage cervical cancer managed by our
clinical partner Numoda;
|
|
·
|
Continue
to work on our grant from the NIH awarded in August 2009 for $210,000 to
develop a single bioengineered Listeria monocytogenes (Lm)
vaccine to deliver two different antigen-adjuvant
proteins.
|
|
·
|
Follow
up on the status of our grant applications with the NIH for $948,000 and
the U.S. Department of Defense Solicitation for up to $3.5
million.
|
|
·
|
Continue
to focus working with government funded or subsidized research in the U.S.
in the treatment of cervical
cancer;
|
|
·
|
Continue
to work with our strategic and development collaborations with academic
laboratories;
|
|
·
|
Continue
the development work necessary to bring ADXS31-142 in the therapeutic
treatment of prostate cancer into clinical trials, and initiate that trial
provided that funding is available;
|
|
·
|
Continue
the development work necessary to bring ADXS31-164 in the therapeutic
treatment of breast cancer into clinical trials, and initiate that trial
when and if funding is available;
and
|
|
·
|
Continue
the pre-clinical development of other product candidates, as well as
continue research to expand our technology
platform.
|
|
·
|
Cost
incurred to date: approximately $1.1
million
|
|
·
|
Estimated
future clinical costs: $5.7 million to $6.0
million
|
|
·
|
Anticipated
Timing: start January 2010; completion August 2012 or
beyond
|
|
·
|
The
FDA (or relevant foreign regulatory authority) may place the project on
clinical hold or stop the project;
|
|
·
|
One
or more serious adverse events in otherwise healthy patients enrolled in
the trial;
|
|
·
|
Difficulty
in recruiting patients;
|
|
·
|
Delays
in the program;
|
|
·
|
Material
cash flows; and
|
|
·
|
Anticipated
Timing: Unknown at this stage and dependent upon successful trials,
adequate fund raising, entering a licensing deal or pursuant to a
marketing collaboration subject to regulatory approval to market and sell
the product.
|
|
·
|
Cost
incurred to date: approximately
$101,650
|
|
·
|
Estimated
future clinical costs: $2.1 million to $2.3
million
|
|
·
|
Anticipated
Timing: start January 2010; completion August 2012 or
beyond
|
|
·
|
One
or more serious adverse events in these late stage cancer patients
enrolled in the trial; and
|
|
·
|
Difficulty
in recruiting patients especially in a new
country.
|
|
·
|
Cost
incurred to date: less than $10,000
|
|
·
|
Estimated
future clinical costs: $500,000 (Government absorbed cost $2.5 million to
$3.0 million)
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Unknown
timing in recruiting patients and conducting the study based on GOG/NCI
controlled study;
|
|
·
|
Delays
in the program; and
|
|
·
|
Given
the economic environment the trial may not get
funded.
|
|
·
|
Cost
incurred to date: approximately
$200,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
New
agent; and
|
|
·
|
FDA
(or foreign regulatory authority) may not approve the
study.
|
|
·
|
Cost
incurred to date: $450,000
|
|
·
|
Estimated
future costs: $3.0 million to $3.5
million
|
|
·
|
Anticipated
Timing: to be determined
|
|
·
|
Clinical
trial expenses decreased by $187,512, or 67%, to $94,013 from $281,525
primarily due to the close out of our Phase I trial in the Fiscal
2008 Period which more than off set the one-half month of start-up cost of
our Phase II cervical cancer study in India in the Fiscal 2009
Period.
|
|
·
|
Wages,
options and lab costs decreased by $171,571 or 19% to $718,850 from
$888,212 principally due to the recording of the full years bonus accrual
in Fiscal 2008 that was reversed in Fiscal 2009 Period or $242,385. No
bonus accrual was recorded nor paid in Fiscal 2009 Period. Overall the lab
costs were lower due to the priority given to the lower cost of grant and
publication writing. These lower costs were partially offset by $107,624
higher option expense relating to new grants in Fiscal 2009 Period and
$40,930 in wages primarily due to the new hire of the Executive Director,
Product Development in March
2008.
|
|
·
|
Consulting
expenses increased by $11,829, or 12%, to $107,709 from $95,880,
principally due to higher option expense of $30,835 recorded in Fiscal
2009 Period relating to new grants as compared to a credit to option
expense of $36,922 due to the true up of unvested option expense recorded
in prior Fiscal periods. This resulted in a $67,757 increase, overall, of
option expense which was offset in part by the lower effort required to
prepare the IND filing for the FDA or $56,928 in the Fiscal 2009 Period
compared to the same period last
year.
|
|
·
|
Subcontracted
research expenses decreased by $121,023, or 100%, to $0 from $121,023
reflecting the completion of the project prior to Fiscal 2009 Period
performed by Dr. Paterson at Penn, pursuant to a sponsored research
agreement ongoing in the Fiscal 2008
Period.
|
|
·
|
Manufacturing
expenses decreased by $547,208, to $41,626 from $588,834, or 93% resulting
from the completion of our clinical supply program for the upcoming CIN
trial prior to Fiscal 2009 Period compared to the manufacturing program in
the Fiscal 2008.
|
|
·
|
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 $113,876, or 12% to $828,290
from $942,166 principally due to the reversal of a nine month bonus
accrual in Fiscal 2009 Period or $79,039 that was recorded as expense in
Fiscal 2008 Period (no bonus accrual was recorded nor paid in Fiscal 2009
Period) and no stock was issued in Fiscal 2009 Period compared to $71,250
worth of stock was issued to the CEO per his employment agreement in
Fiscal 2008 Period. These lower expenses were partially offset
by higher option expense of $45,975 primarily due to new stock options
granted in Fiscal 2009 Period resulting in a $105,112 expense partially
offset by lower option expenses recorded in Fiscal 2009 Period due to the
nine months vesting of the CEO’s options in Fiscal 2008 Period compared to
two months of vesting of his options in the Fiscal 2009
Period.
|
|
·
|
Consulting
fees decreased by $272,769, or 73%, to $99,150 from $371,919. This
decrease was primarily attributed to a one-time payment in settlement of
Mr. Appel’s (our previous President & CEO) employment agreement of
$130,000 recorded in the Fiscal 2008 Period. The consulting expenses
were also $180,571 lower due to reduced financial advisor fees in Fiscal
2009 Period compared to $200,571 recorded in the Fiscal 2008 Period
primarily due to the close of the offering on October 17, 2007. These
lower fees were partially offset by $50,000 fees recorded for the Sage
Group in Fiscal 2009 Period for seeking corporate partnerships that did
not occur in Fiscal 2008 Period.
|
|
·
|
Offering
expenses increased by $302,505 to $335,633 from $33,128. The offering
expenses of $351,973 recorded included in Fiscal 2009 Period or an
increase of $318,845 consists of legal costs in preparation for financial
raises and SEC filings that did not occur in Fiscal 2008 Period, partially
offset by non-cash warrants
expense.
|
|
·
|
An
increase in legal, accounting, professional and public relations expenses
of $77,121, or 18%, to $516,521 from $439,400, primarily as a result of a
higher overall legal, patent expenses of $114,049 partially offset by
lower accounting, Public relations and tax preparation fees in Fiscal 2009
Period than in the Fiscal 2008
Period.
|
|
·
|
Amortization
of intangibles and depreciation of fixed assets increased by $3,090, or
4%, to $81,860 from $78,770 primarily due to an increase in fixed assets
and intangibles in the Fiscal 2009 Period compared to the Fiscal 2008
Period.
|
|
·
|
Analysis
Research cost decreased by $117,990 or 100%, to $0 from $117,990 due to a
one time report and business analysis report in the Fiscal 2008 Period not
repeated in Fiscal 2009 Period.
|
|
·
|
Recruiting
fees for the Executive Director of Product Development in Fiscal 2008
Period was $63,395 and there was no such expense in Fiscal 2009
Period.
|
|
·
|
Overall
occupancy and conference related expenses decreased by $123,110 or 41% to
$179,561 from $302,672. Conference and dues and subscription expenses have
decreased by $89,044 in the Fiscal 2009 Period due to lower participation
in cancer conferences. In addition lower travel related to the reduced
conferences attendance amounted to a decrease of $21,061 in the Fiscal
2009 Period than incurred in Fiscal 2008
Period.
|
|
·
|
It
requires assumption to be made that were uncertain at the time the
estimate was made, and
|
|
·
|
Changes
in the estimate of difference estimates that could have been selected
could have material impact in our results of operations or financial
condition.
|
Product
|
Indication
|
Stage
|
||
ADXS11-001
|
Cervical
Cancer
|
Phase I Company
sponsored & completed in 2007.
|
||
Cervical
Intraepithelial Neoplasia
|
Phase II Company
sponsored study anticipated to commence in January 2010.
|
|||
Cervical
Cancer
|
Phase II Company
sponsored study anticipated to commence in January 2010 in India. 110
Patients with advanced cervical cancer.
|
|||
Cervical
Cancer
|
Phase II The Gynecologic
Oncology Group of the National Cancer Institute may conduct a study
(timing to be determined).
|
|||
ADXS31-142
|
Prostate
Cancer
|
Phase I Company
sponsored (timing to be determined).
|
||
ADXS31-164
|
Breast
Cancer
|
Phase I Company
sponsored (timing to be
determined).
|
|
1.
|
Very
strong innate immune response
|
|
2.
|
Stimulates
inordinately strong killer Tregs
response
|
|
3.
|
Stimulates
helper Tregs
|
|
4.
|
Stimulates
release of and/or up-regulates immuno-stimulatory cytokines, chemokines,
co-stimulatory molecules
|
|
5.
|
Adjuvant
activity creates a local tumor environment that supports anti-tumor
efficacy
|
|
6.
|
Minimizes
inhibitory Tregs and inhibitory cytokines and shifts to Th-17
pathway
|
|
7.
|
Stimulates
the development and maturation of all Antigen Presenting Cells and
effector Tregs & reduces immature myeloid
cells
|
|
8.
|
Eliminates
sources of endogenous inhibition present within tumors that suppress
activated immune cells and prevent them from working within
tumors
|
|
9.
|
Effecting
non-immune systems that support the immune response, like the vascular
system, the marrow, and the maturation of cells in the blood
stream
|
|
10.
|
Enables
epitope spreading to increase the number of antigens attacked by the
immune system.
|
|
·
|
Who
must be recruited as qualified participants and who is to be
excluded;
|
|
·
|
how
often, and how to administer the drug and at what
dose(s);
|
|
·
|
what
tests to perform on the participants;
and
|
|
·
|
what
evaluations are to be made and how the data will be
assessed.
|
Name
|
Age
|
Position
|
||
Thomas
A. Moore
|
58
|
Chief
Executive Officer and Chairman of our Board of
Directors
|
||
Dr.
James Patton
|
51
|
Director
|
||
Roni
A. Appel
|
42
|
Director
|
||
Dr.
Thomas McKearn
|
60
|
Director
|
||
Richard
Berman
|
67
|
Director
|
||
John
Rothman, Ph.D.
|
61
|
Executive
Vice President of Clinical and Scientific Operations
|
||
Fredrick
D. Cobb
|
62
|
Vice
President, Finance and Principal Financial Officer
|
||
Christopher
C. Duignan
|
34
|
Senior
Vice President of
Finance
|
|
·
|
reviewing
the results of the audit engagement with the independent registered public
accounting firm;
|
|
·
|
identifying
irregularities in the management of our business in consultation with our
independent accountants, and suggesting an appropriate course of
action;
|
|
·
|
reviewing
the adequacy, scope, and results of the internal accounting controls and
procedures;
|
|
·
|
reviewing
the degree of independence of the auditors, as well as the nature and
scope of our relationship with our independent registered public
accounting firm;
|
|
·
|
reviewing
the auditors’ fees; and
|
|
·
|
recommending
the engagement of auditors to the full board of
directors.
|
|
·
|
identifying
and recommending to the board of directors individuals qualified to serve
as members of our board of directors and on the committees of the
board;
|
|
·
|
advising
the board with respect to matters of board composition, procedures and
committees;
|
|
·
|
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally
including review of possible conflicts and transactions with persons
affiliated with directors or members of management;
and
|
|
·
|
overseeing
the annual evaluation of the board and our
management.
|
Name and
Principal
Position
|
Fiscal Year
|
Salary
|
Bonus
|
Stock
Award(s)
(1)
|
Option
Award(s)
(1)
|
All Other
Compensation
|
Total
|
|||||||||||||||||||
Thomas A.
Moore,
|
2008
|
$ | 352,692 | $ | — | $ | — | $ | 156,364 | $ | 27,626 | (2) | $ | 536.682 | ||||||||||||
CEO
and Chairman
|
2007
|
220,769 | — | 172,500 | 129,813 | 23,976 | (2) | 547,058 | ||||||||||||||||||
Dr.
John Rothman,
|
2008
|
255,000 | 55,000 | 23,378 | (3) | 25,092 | 27,862 | (4) | 386,332 | |||||||||||||||||
Executive
VP of Science & Operations
|
2007
|
173,923 | 45,000 | 44,497 | (5) | 23,128 | 27,497 | (4) | 314,045 | |||||||||||||||||
Fredrick
D. Cobb,
|
2008
|
182,923 | 40,000 | 15,585 | (6) | 19,977 | 7,136 | (7) | 265,621 | |||||||||||||||||
VP
Finance
|
2007
|
144,731 | 28,000 | 22,353 | (8) | 13,863 | 9,358 | (7) | 218,305 |
(1)
|
The
amounts shown in this column represents the compensation expense incurred
by us for the fiscal year in accordance with FAS 123(R) using the
assumptions described under “Share-Based Compensation
Expense” in Note 2 to our financial statements included elsewhere
in this prospectus.
|
(2)
|
Based
on our cost of his coverage for health care and the payment of interest
earned on his loans to us.
|
(3)
|
Represents:
(i) $30,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 196,339 shares earned, but not
issued.
|
(4)
|
Based
on our cost of his coverage for health care and the 401K company match he
received.
|
(5)
|
Represents:
(i) $30,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 44,945 shares earned, but not
issued.
|
(6)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 130,893 shares earned, but not
issued.
|
(7)
|
Based
on our cost of the 401K company match he
received.
|
(8)
|
Represents:
(i) $20,000 of base salary paid in shares of our common stock in lieu of
cash, based on the average monthly stock price, with the minimum set at
$0.20 per share, and (ii) the compensation expense incurred in connection
with 29,964 shares earned, but not
issued.
|
Option Awards
|
Stock Awards
|
||||||||||||||||||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Equity
Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)
|
Market Value
of Shares or
Units of Stock
That Have
Not Vested ($)
|
Equity Incentive
Plan Awards:
Number of
Unearned
Shares, Units or
Other Rights
That Have Not
Vested (#)
|
Equity Incentive Plan
Awards: Market or
Payout Value of
Unearned Shares,
Units or Other Rights
That Have
Not Vested ($)
|
||||||||||||||||||||||||
Thomas
A. Moore
|
2,200,000 | 200,000 | (1) | — | 0.143 |
12/15/16
|
750,000 | (2) | $ | 30,000 | (3) | — | — | ||||||||||||||||||||
Dr.
John Rothman
|
315,000 | 45,000 | (3) | — | 0.287 |
3/1/15
|
— | — | — | — | |||||||||||||||||||||||
93,750 | 56,250 | (4) | — | 0.260 |
3/29/16
|
— | — | — | — | ||||||||||||||||||||||||
112,500 | 187,500 | (5) | — | 0.165 |
2/15/17
|
— | — | — | — | ||||||||||||||||||||||||
Fredrick
D. Cobb (5)
|
93,750 | 56,250 | (6) | — | 0.260 |
2/20/16
|
— | — | — | — | |||||||||||||||||||||||
75,000 | 75,000 | (7) | — | 0.160 |
9/21/16
|
— | — | — | — | ||||||||||||||||||||||||
56,250 | 93,750 | (8) | — | 0.165 |
2/15/17
|
— | — | — | — |
(1)
|
Of
these options, 100,000 became exercisable on each of November 15, 2008 and
December 15, 2008.
|
(2)
|
In
connection with our hiring of Mr. Moore, we agreed to grant Mr. Moore up
to 1,500,000 shares of our common stock, of which 750,000 shares were
issuable on November 1, 2007 upon our successful raise of $4.0 million and
750,000 shares are issuable upon our successful raise of an additional
$6.0 million.
|
(3)
|
Based
on the closing sale price of $0.04 per share of common stock on October
31, 2008 (the last day of our fiscal
year).
|
(4)
|
Of
these options, 22,500 became exercisable on each of December 1, 2008 and
March 1, 2009.
|
(5)
|
Of
these options, 9,375 became exercisable on each of December 29, 2008,
March 29, 2009, June 29, 2009 and September 29, 2009 and 9,375 become
exercisable on each of December 29, 2009 and March 29,
2010.
|
(6)
|
Of
these options, 18,750 became exercisable on each of November 15, 2008,
February 15, 2009, May 15, 2009 and August 15, 2009 and 18,750 become
exercisable on each November 15, February 15, May 15 and August 15 of each
year until February 15, 2011.
|
(7)
|
Of
these options, 9,375 became exercisable on each of November 20, 2008,
February 20, 2009, May 20, 2009 and August 20, 2009 and 9,375 become
exercisable on each of November 20, 2009 and February 20,
2010.
|
(8)
|
Of
these options, 9,375 became exercisable on each of December 21, 2008,
March 21, 2009, June 21, 2009 and September 21, 2009 and 9,375 become
exercisable on December 21, 2009, March 21, 2010, June 21, 2010 and
September 21, 2010.
|
(9)
|
Of
these options, 9,375 became exercisable on each November 15, 2008,
February 15, 2009, May 15, 2009 and August 15, 2009 and 9,375 become
exercisable on each November 15, February 15, May 15 and August 15 of each
year until February 15, 2011.
|
Name
|
Fees
Earned
or Paid
in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
All other
Compensation
($)
|
Total
($)
|
|||||||||||||||
Roni
A. Appel
|
$ | 1,500 | $ | 240 | $ | — | — | $ | 1,740 | |||||||||||
Dr.
James Patton
|
8,250 | 6,000 | (1) | — | — | 14,250 | ||||||||||||||
Dr.
Thomas McKearn
|
7,500 | 6,000 | (1) | 11,424 | (2) | — | 24,924 | |||||||||||||
Martin R.
Wade III*
|
- | 3,600 | (1) | 11,424 | (2) | — | 15,024 | |||||||||||||
Richard
Berman
|
2,250 | 27,247 | (3) | 10,000 | (4) | — | 39,497 |
|
(1)
|
Based
on the board of directors’ compensation plan subject to approval by
stockholders paying 6,000 shares a quarter if the member attends at least
75% of the meetings annually.
|
|
(2)
|
Based
on the vesting of 150,000 options of our common stock granted on March 29,
2006 at a market price of $0.261 share. Vests quarterly over a
three year period at a fair value of $0.1434 share value Black Scholes
Model at grant date. In 2006, based on vesting of 150,000
options of our common stock granted on October 1, 2003 at a market price
of $0.1952 share. Vests quarterly over a three year period at a
fair value of $0.14 per share (Black Scholes
Model).
|
|
(3)
|
Includes
a retroactive adjustment of shares based on the average monthly closing
prices of our common stock for the $2,000 monthly compensation as compared
to the $0.50 per share or 4,000 shares per month. The total
shares issued in fiscal year 2008 was 245,844 and the total shares earned
but not issued was 192,899.
|
|
(4)
|
Based
on the vesting of 400,000 options of our common stock granted at $0.287
per share on February 1, 2005. The option vests quarterly over
four years.
|
|
·
|
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
|
6,867,368 | (1) | 5.8 | % | ||||
Roni
A. Appel
|
6,751,419 | (2) | 5.6 | % | ||||
Richard
Berman
|
2,103,954 | (3) | 1.8 | % | ||||
Dr.
James Patton
|
3,355,394 | (4) | 2.9 | % | ||||
Dr.
Thomas McKearn
|
832,372 | (5) | * | |||||
Dr.
John Rothman
|
2,036,281 | (6) | 1.7 | % | ||||
Fredrick
Cobb
|
1,085,812 | (7) | * | |||||
All
Directors and Executive Officers as a Group (7 people)
|
23,032,600 | (8) | 18.1 | % |
(1)
|
Represents
3,425,700 shares of our common stock and options to purchase
3,441,668 shares of our common stock exercisable within 60
days. In addition, Mr. Moore owns warrants to purchase
4,511,790 shares of our common stock, limited by a 4.99% beneficial
ownership provision in the warrants that would prohibit him from
exercising any of such warrants to the extent that upon such exercise he,
together with his affiliates, would beneficially own more than
4.99% of the total number of shares of our common stock then issued and
outstanding (unless Mr. Moore provides us with 61 days' notice of the
holders waiver of such provisions).
|
(2)
|
Represents
4,130,134 shares of our common stock, options to purchase 2,524,923 shares
of our common stock exercisable within 60 days, warrants to purchase
72,362 shares of our common stock exercisable within 60 days and 24,000
shares of our common stock earned but not yet issued. In
addition, Mr. Appel owns warrants to purchase 648,094 shares of our common
stock, limited by a 4.99% beneficial ownership provision in the warrants
that would prohibit him from exercising any of such warrants to the
extent that upon such exercise he, together with his affiliates,
would beneficially own more than 4.99% of the total number of shares
of our common stock then issued and outstanding (unless Mr. Appel provides
us with 61 days' notice of the holders waiver of such provisions).
|
(3)
|
Represents
760,624 shares of our common stock, options to purchase 608,333 shares of
our common stock exercisable within 60 days and 734,997 shares of our
common stock earned but not yet
issued.
|
(4)
|
Represents
2,820,576 shares of our common stock, options to purchase 219,086 shares
of our common stock exercisable within 60 days, warrants to purchase
267,732 shares of our common stock exercisable within 60 days and 48,000
shares earned but not yet issued.
|
(5)
|
Represents
179,290 shares of our common stock, options to purchase 441,096 shares of
our common stock exercisable within 60 days, warrants to purchase 163,986
shares of our common stock exercisable within 60 days and 48,000 shares of
our common stock earned but not yet
issued.
|
(6)
|
Represents
275,775 shares of our common stock, options to purchase 1,426,667 shares
of our common stock exercisable within 60 days and 333,839 shares of
our common stock earned but not yet
issued.
|
(7)
|
Represents
90,336 shares of our common stock, options to purchase 772,917 shares of
our common stock exercisable within 60 days and 222,559
shares of our common stock earned but not yet
issued.
|
(8)
|
Represents
an aggregate of 11,682,435 shares of our common stock, options to purchase
9,434,690 shares of our common stock exercisable within 60 days, warrants
to purchase 504,080 shares of our common stock exercisable within 60 days
and 1,411,395 shares of our common stock earned but not yet
issued.
|
Selling
Stockholder
|
Shares Beneficially
Owned Before
Offering (1)
|
Shares Being
Offered
|
Shares to be Beneficially
Owned After
Offering
|
Percentage to be Beneficially
Owned After
Offering
|
|||||||||||
2056850
Ontario Inc.
|
1,168,924 | 500,000 | 668,924 |
*
|
|||||||||||
Alpha
Capital
|
1,250,000 | 1,250,000 | 0 |
—
|
|||||||||||
Andrew
Latos
|
592,909 | 275,000 | 317,909 |
*
|
|||||||||||
Anthony
G. Polak
|
250,000 | 250,000 | 0 |
—
|
|||||||||||
Ariel
Shatz and Talya Miron-Shatz
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Arthur
& Christine Handal
|
125,000 | 125,000 | 0 |
—
|
|||||||||||
Gerald
A. Brauser TTEE FBO Bernice Brauser
Irrevocable Trust
|
1,753,383 | 750,000 | 1,003,383 |
*
|
|||||||||||
Bridge
Ventures, Inc. (2)
|
950,678 | 150,000 | 800,678 |
*
|
|||||||||||
Brio
Capital LP
|
1,553,888 | 750,000 | 803,888 |
*
|
|||||||||||
CAMOFI
Master LDC (3)(4)
|
9,986,666 | 8,000,000 | 1,986,666 |
1.7%
|
|||||||||||
CAMHZN
Master LDC (4)(5)
|
2,496,667 | 2,000,000 | 496,667 |
*
|
|||||||||||
Carter
Management Group LLC (6)
|
606,194 | 375,000 | 231,194 |
*
|
|||||||||||
Cary
Fields
|
2,630,081 | 1,125,000 | 1,505,081 |
1.3%
|
|||||||||||
Castlerigg
Master Investments, Ltd.
|
4,975,000 | 4,975,000 | 0 |
—
|
|||||||||||
Chestnut
Ridge Partners LP
|
3,000,000 | 3,000,000 | 0 |
—
|
|||||||||||
Christopher
Kyriakides
|
807,500 | 757,500 | 50,000 |
*
|
|||||||||||
David
Ismailer
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Dr.
Philip and Maxine Patt
|
2,045,619 | 875,000 | 1,170,619 |
1.0%
|
|||||||||||
Emilio
DiSanluciano
|
250,000 | 250,000 | 0 |
—
|
|||||||||||
Endeavor
Asset Mgmt.
|
953,826 | 500,000 | 453,826 |
*
|
|||||||||||
Flavio
Sportelli
|
263,009 | 112,500 | 150,509 |
*
|
|||||||||||
Gerald
Cohen
|
350,678 | 150,000 | 200,678 |
*
|
|||||||||||
Gregory
William Eagan
|
350,678 | 150,000 | 200,678 |
*
|
|||||||||||
IRA
FBO Ronald M. Lazar
|
75,000 | 75,000 | 0 |
—
|
|||||||||||
Isaac
Cohen
|
116,893 | 50,000 | 66,893 |
*
|
|||||||||||
Jack
Erlanger
|
125,000 | 125,000 | 0 |
—
|
|||||||||||
John
Golfinos
|
1,168,926 | 500,000 | 668,926 |
*
|
|||||||||||
John
Lilly (7)
|
2,651,573 | 750,000 | 1,901,573 |
1.6%
|
|||||||||||
Joseph
Giamanco
|
375,000 | 375,000 | 0 |
—
|
|||||||||||
Julie
Arkin
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Keith
M Rosenbloom
|
292,232 | 125,000 | 167,232 |
*
|
|||||||||||
Leonard
Cohen
|
350,678 | 150,000 | 200,678 |
*
|
|||||||||||
Lipman
Capital Group Inc. Retirement Plan (6)
|
638,555 | 288,750 | 349,805 |
*
|
|||||||||||
Mary
Tagliaferri
|
116,893 | 50,000 | 66,893 |
*
|
|||||||||||
Michael
Freedman
|
125,000 | 125,000 | 0 |
—
|
|||||||||||
Michael
Miller
|
375,000 | 375,000 | 0 |
—
|
|||||||||||
Michael
Sobeck
|
62,500 | 62,500 | 0 |
—
|
|||||||||||
Micro
Capital Fund LP
|
1,130,081 | 1,125,000 | 5,081 |
*
|
|||||||||||
Micro
Capital Fund Ltd.
|
375,000 | 375,000 | 0 |
—
|
|||||||||||
Oppenheimer &
Co. Inc. (8)
|
375,000 | 375,000 | 0 |
—
|
|||||||||||
Optimus
CG II, Ltd. (9)
|
0 | 33,750,000 | 0 |
—
|
|||||||||||
Othon
Mourkakos
|
1,883,388 | 750,000 | 1,133,388 |
1.0%
|
|||||||||||
Pan
Brothers
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Peter
Latos, Esq.
|
400,000 | 400,000 | 0 |
—
|
|||||||||||
Peter
Malo
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Philip
DiPippo
|
444,463 | 250,000 | 194,463 |
*
|
|||||||||||
Phylis
Meier
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
Platinum
Long Term Growth VII
|
5,000,000 | 5,000,000 | 0 |
—
|
|||||||||||
Revach
|
509,463 | 250,000 | 259,463 |
*
|
|||||||||||
RL
Capital Partners (10)
|
125,000 | 125,000 | 0 |
—
|
|||||||||||
Robert
& Donna Goode
|
75,000 | 75,000 | 0 |
—
|
|||||||||||
Robert
Allen Papiri
|
848,442 | 275,000 | 573,442 |
*
|
|||||||||||
Robert
H. Cohen (11)
|
6,046,324 | 2,500,000 | 3,546,324 |
3.1%
|
|||||||||||
Spallino
Family Trust
|
292,232 | 125,000 | 167,232 |
*
|
|||||||||||
Steven
B. Gold IRA, Charles Schwab & Co., Inc.,
Custodian (12)
|
752,191 | 250,000 | 502,191 |
*
|
|||||||||||
Steven
J. Shankman
|
301,355 | 300,000 | 1,355 |
*
|
|||||||||||
Suzanne
Henry
|
584,463 | 250,000 | 334,463 |
*
|
|||||||||||
MLPF
CUST FBO Thomas A. Moore IRRA(13)
|
11,379,157 | 2,000,000 | 9,379,157 |
7.5%
|
|||||||||||
Whalehaven
Capital Fund Limited
|
1,250,000 | 1,250,000 | 0 |
—
|
|||||||||||
Zenith
Capital Corporation Money Purchase Pension Plan
|
375,000 | 375,000 | 0 |
—
|
(1)
|
Except
as otherwise indicated in the footnotes to this table, the number and
percentage of shares beneficially owned is determined in accordance with
Rule 13d-3 of the Exchange Act, and the information is not necessarily
indicative of beneficial ownership for any other purpose. Under such rule,
beneficial ownership includes any shares as to which the selling
stockholder has sole or shared voting power or investment power and also
any shares, which the selling stockholder has the right to acquire within
60 days.
|
(2)
|
Pursuant
to a consulting agreement between us and Bridge Ventures dated as of March
15, 2007, as amended on October 17, 2007, we granted Bridge Ventures
five-year warrants to purchase 800,000 shares of our common stock at $0.20
per share and agreed to pay Bridge Ventures an initial fee of $60,000 and
a monthly fee of $5,000 for six months, unless extended. The agreement
secured the consults services in overall strategic planning, business
opportunities and related services.
|
(3)
|
CAMOFI
holds warrants to purchase 9,986,666 shares of our common stock limited by
a 4.99% beneficial ownership provision that would prohibit CAMOFI from
exercising any of such warrants to the extent that upon such exercise,
CAMOFI , together with its affiliates, would beneficially own more
than 4.99% of the total number of shares of our common stock then issued
and outstanding, unless it provides us with 61 days’ notice of its waiver
of such provisions. CAMOFI is an affiliate of CAMHZN and each of them are
affiliates of our financial advisor,
Centrecourt.
|
(4)
|
Pursuant
to a consulting agreement between us and Centrecourt dated August 1, 2007,
we paid Centrecourt $328,000 in cash and issued to it 2,483,333 $0.20
warrants for strategic advisory services provided to us. Centrecourt
transferred the $0.20 warrants to CAMOFI and CAMHZN. Centrecourt disclaims
beneficial ownership of all of our
securities.
|
(5)
|
CAMHZN
holds warrants to purchase 2,496,667 shares of our common stock limited by
a 4.99% beneficial ownership provision that would prohibit CAMHZN from
exercising any of such warrants to the extent that upon such exercise,
CAMHZN, together with its affiliates, would beneficially own more
than 4.99% of the total number of shares of our common stock then issued
and outstanding, unless it provides us with 61 days’ notice of its
waiver of such provisions. CAMHZN is an affiliate of CAMOFI and each of
them are affiliates of Centrecourt. Centrecourt disclaims beneficial
ownership of all of our
securities.
|
(6)
|
John
C. Lipman is the managing and sole member of Carter Management Group LLC
and the owner of Lipman Capital Group, Inc. Retirement
Plan. Mr. Lipman is also the sole owner of Carter Securities
LLC, the placement agent in connection with our October 2007 private
placement. Pursuant to the related placement agency agreement,
Carter Securities, LLC received $354,439 in cash commissions,
reimbursement of expenses and warrants to purchase 2,949,333 shares of our
common stock with an exercise price of $0.20 per share. Each of
these entities has advised us that (i) it acquired the common stock and
warrants in the ordinary course of business and (ii) at the time of the
purchase of the common stock and warrants to be resold, it did not have
any agreement or understanding, directly or indirectly, to distribute the
shares of common stock and warrants offered hereunder. Mr.
Lipman is presently a managing director of EarlyBirdCapital, Inc., a FINRA
member.
|
(7)
|
In
connection with a bridge loan bearing interest at 12%, Mr. Lilly received
five-year warrants to purchase 37,500 shares of our common stock at $0.287
per share.
|
(8)
|
Oppenheimer
& Co. Inc. advised us that it is a registered broker-dealer.
Oppenheimer & Co. Inc. further advised us that (i) it acquired the
common stock and warrants in the ordinary course of business and (ii) at
the time of the purchase of the common stock and warrants to be resold, it
did not have any agreement or understanding, directly or indirectly, to
distribute the shares of common stock and warrants offered
hereunder.
|
(9)
|
The
sole stockholder of Optimus CG II, Ltd. is Optimus Capital Partners, LLC,
d/b/a Optimus Life Sciences Capital Partners, LLC. Voting and dispositive
power with respect to the shares held by Optimus CG II, Ltd. is exercised
by Terry Peizer, the Managing Director of Optimus Life Sciences Capital
Partners, LLC, who acts as investment advisor to Optimus CG II, Ltd.
Optimus CG II, Ltd. is not a registered broker-dealer or an affiliate of a
registered broker-dealer. On September 24, 2009, we issued to Optimus
CG II, Ltd., pursuant to the Optimus purchase agreement, a three-year
warrant to purchase up to 33,750,000 shares of our common stock, at an
initial exercise price of $0.20 per share, subject to adjustment as
provided in the warrant. The warrant will become exercisable upon the
effectiveness of the registration statement of which this prospectus forms
a part.
|
(10)
|
Ronald
Lazar and Anthony Polak are the Managing Members of RL Capital Management,
LLC, the General Partner of RL Capital
Partners.
|
(11)
|
Includes
warrants to purchase 2,500,000 shares of our common stock, which are
limited by a 4.99% beneficial ownership provision in the warrants that
would prohibit Mr. Cohen from exercising any of such warrants to the
extent that upon such exercise he, together with his affiliates, would
beneficially own more than 4.99% of the total number of shares of our
common stock then issued and outstanding (unless Mr. Cohen provides us
with 61 days' notice of the holders waiver of such
provisions).
|
(12)
|
In
connection with a bridge loan bearing interest at 12%, Mr. Gold received
five-year warrants to purchase 12,500 shares of our common stock at $0.287
per share.
|
(13)
|
Shares
held by MLPF&S CUST FBO Thomas A. Moore are for the benefit of Mr.
Moore, our chief executive officer and Chairman of the board of directors.
This number represents 3,425,700 shares of our common stock, options to
purchase 3,441,668 shares of our common stock exercisable within 60 days,
and warrants to purchase 4,511,790 shares of our common stock, which are
limited by a 4.99% beneficial ownership provision in the warrants that
would prohibit him from exercising any of such warrants to the extent
that upon such exercise he, together with his affiliates, would
beneficially own more than 4.99% of the total number of shares of our
common stock then issued and outstanding (unless Mr.
Moore provides us with 61 days' notice of the holders waiver of such
provisions).
|
|
·
|
senior
to our common stock and any other class or series of preferred stock
(other than a class or series of preferred stock that we intend to cause
to be listed for trading or quoted on Nasdaq, NYSE Amex or the New York
Stock Exchange); and
|
|
·
|
junior
to all of our existing and future indebtedness and any class or series of
preferred stock that we intend to cause to be listed for trading or quoted
on Nasdaq, NYSE Amex or the New York Stock
Exchange.
|
|
·
|
our
common stock must be listed for trading or quoted on the OTC Bulletin
Board (or another eligible trading market), and we must be in compliance
with all reporting requirements under the Securities Exchange Act of 1934,
as amended, in order to maintain such
listing;
|
|
·
|
either
(i) we have a current, valid and effective registration statement covering
the resale of all shares underlying the warrant or (ii) all shares
underlying the warrant are eligible for resale without limitation under
Rule 144 (assuming cashless exercise of the
warrant);
|
|
·
|
there
must not be any material adverse effect with respect to the company since
the date we executed the purchase agreement, other than losses incurred in
the ordinary course of business;
|
|
·
|
we
must not be in default under any material
agreement;
|
|
·
|
ten
trading day lock-up agreements, subject to certain extensions, with our
senior officers and directors and certain beneficial owners of 10% or more
of our outstanding common stock must be
effective;
|
|
·
|
there
must not be any legal restraint prohibiting the transactions contemplated
by the purchase agreement; and
|
|
·
|
the
aggregate of all shares of our common stock beneficially owned by Optimus
and its affiliates must not exceed 9.99% of our outstanding common
stock.
|
|
·
|
1%
of the number of shares of our common stock then outstanding, which
equaled 1,156,382 shares as of October 1, 2009,
or
|
|
·
|
the
average weekly trading volume of our common stock on the OTC Bulletin
Board during the four calendar weeks preceding the filing of a notice on
Form 144 with respect to that sale.
|
|
·
|
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, 2008 and 2007
|
F-4
|
Statements
of Operations for the years ended October 31, 2008 and 2007 and the period
from March 1, 2002 (Inception) to October 31, 2008
|
F-5
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to October 31, 2008
|
F-6
|
Statements
of Cash Flows for the years ended October 31, 2008 and 2007 and the period
from March 1, 2002 (Inception) to October 31, 2008
|
F-8
|
Notes
to Financial Statements
|
F-10
|
Unaudited
Interim Financial Statements
|
|
Balance
Sheets as of July 31, 2009 (unaudited) and October 31,
2008
|
F-29
|
Statements
of Operations for the three and nine month periods ended July 31, 2009 and
2008 and the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
F-30
|
Statements
of Cash Flow for the nine month periods ended July 31, 2009 and 2008 and
the period March 1, 2002 (inception) to July 31, 2009
(unaudited)
|
F-31
|
Notes
to Unaudited Financial Statements
|
F-33
|
October 31,
2008
|
October 31,
2007
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 59,738 | $ | 4,041,984 | ||||
Prepaid
expenses
|
38,862 | 199,917 | ||||||
Total
Current Assets
|
98,600 | 4,241,901 | ||||||
Property
and Equipment (net of accumulated depreciation of $92,090 at October 31,
2008 and $55,953 at October 31, 2007)
|
91,147 | 116,442 | ||||||
Intangible
Assets (net of accumulated amortization of $205,428 at October 31,
2008 and $149,132 at October 31, 2007)
|
1,137,397 | 1,098,135 | ||||||
Other
Assets
|
3,876 | 3,876 | ||||||
Total
Assets
|
$ | 1,331,020 | $ | 5,460,354 | ||||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 998,856 | $ | 787,297 | ||||
Accrued
expenses
|
603,345 | 305,023 | ||||||
Notes
payable – current portion including interest payable
|
563,317 | 80,409 | ||||||
Total
Current Liabilities
|
2,165,518 | 1,172,729 | ||||||
Notes
payable - net of current portion
|
4,813 | 19,646 | ||||||
Total
Liabilities
|
$ | 2,170,331 | $ | 1,192,375 | ||||
Shareholders’
Equity (Deficiency):
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and
outstanding
|
– | – | ||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 109,319,520 at October 31, 2008; and 107,957,777 at October
31, 2007
|
109,319 | 107,957 | ||||||
Additional
Paid-In Capital
|
16,584,414 | 16,276,648 | ||||||
Deficit
accumulated during the development stage
|
(17,533,044 | ) | (12,116,626 | ) | ||||
Total
Shareholders’ (Deficiency) Equity
|
(839,311 | ) | 4,267,979 | |||||
TOTAL
LIABILITIES & SHAREHOLDERS’ DEFICIENCY
|
$ | 1,331,020 | $ | 5,460,354 |
Year Ended
October 31, 2008
|
Year Ended
October 31, 2007
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
||||||||||
Revenue
|
$ | 65,736 | $ | 154,201 | $ | 1,325,172 | ||||||
Research
& Development Expenses
|
2,481,840 | 2,128,096 | 7,857,984 | |||||||||
General
& Administrative Expenses
|
3,035,680 | 2,629,094 | 10,008,567 | |||||||||
Total
Operating expenses
|
5,517,520 | 4,757,190 | 17,866,551 | |||||||||
Loss
from Operations
|
(5,451,784 | ) | (4,602,989 | ) | (16,541,379 | ) | ||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(11,263 | ) | (607,193 | ) | (1,084,483 | ) | ||||||
Other
Income
|
46,629 | 63,406 | 246,457 | |||||||||
Gain
on note retirement
|
– | 1,532,477 | 1,532,477 | |||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
– | 1,159,846 | (1,642,232 | ) | ||||||||
Net
loss
|
(5,416,418 | ) | (2,454,453 | ) | (17,489,160 | ) | ||||||
Dividends
attributable to preferred shares
|
– | – | 43,884 | |||||||||
Net
loss applicable to Common Stock
|
$ | (5,416,418 | ) | $ | (2,454,453 | ) | $ | (17,533,044 | ) | |||
Net
loss per share, basic and diluted
|
$ | (0.05 | ) | $ | (0.05 | ) | ||||||
Weighted
average number of shares outstanding, basic and diluted
|
108,715,875 | 46,682,291 |
Preferred Stock
|
Common Stock
|
|||||||||||||||||||||||||||
Number of
Shares
outstanding
|
Amount
|
Number of
Shares
outstanding
|
Amount
|
Paid-in
Additional
Capital
|
Deficit
Accumulated
During the
Development
Stage
|
Shareholders’
Equity
(Deficiency)
|
||||||||||||||||||||||
Preferred
stock issued
|
3,418 | $ | 235,000 | $ | 235,000 | |||||||||||||||||||||||
Common
Stock Issued
|
40,000 | $ | 40 | $ | (40 | ) | 0 | |||||||||||||||||||||
Options
granted to consultants & professionals
|
10,493 | 10,493 | ||||||||||||||||||||||||||
Net
Loss
|
(166,936 | ) | (166,936 | ) | ||||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov.12, 2004
|
(3,481 | ) | (235,000 | ) | 15,557,723 | 15,558 | 219,442 | – | ||||||||||||||||||||
Balance
at December 31, 2002
|
15,597,723 | $ | 15,598 | $ | 229,895 | $ | (166,936 | ) | $ | 78,557 | ||||||||||||||||||
Note
payable converted into preferred stock
|
232 | 15,969 | 15,969 | |||||||||||||||||||||||||
Options
granted to consultants and professionals
|
8,484 | 8,484 | ||||||||||||||||||||||||||
Net
loss
|
(909,745 | ) | (909,745 | ) | ||||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(232 | ) | (15,969 | ) | 15,969 | – | ||||||||||||||||||||||
Balance
at December 31, 2003
|
15,597,723 | $ | 15,598 | $ | 254,348 | $ | (1,076,681 | ) | $ | (806,735 | ) | |||||||||||||||||
Stock
dividend on preferred stock
|
638 | 43,884 | (43,884 | ) | – | |||||||||||||||||||||||
Net
loss
|
(538,076 | ) | (538,076 | ) | ||||||||||||||||||||||||
Options
granted to consultants and professionals
|
5,315 | 5,315 | ||||||||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov.12, 2004
|
(638 | ) | (43,884 | ) | 43,884 | – | ||||||||||||||||||||||
Balance
at October 31, 2004
|
15,597,723 | $ | 15,598 | $ | 303,547 | $ | (1,658,641 | ) | $ | (1,339,496 | ) | |||||||||||||||||
Common
Stock issued to Placement Agent on re-capitalization
|
752,600 | 753 | (753 | ) | – | |||||||||||||||||||||||
Effect
of re-capitalization
|
752,600 | 753 | (753 | ) | – | |||||||||||||||||||||||
Options
granted to consultants and professionals
|
64,924 | 64,924 | ||||||||||||||||||||||||||
Conversion
of Note payable to Common Stock
|
2,136,441 | 2,136 | 611,022 | 613,158 | ||||||||||||||||||||||||
Issuance
of Common Stock for cash, net of shares to Placement Agent
|
17,450,693 | 17,451 | 4,335,549 | 4,353,000 | ||||||||||||||||||||||||
Issuance
of common stock to consultant
|
586,970 | 587 | 166,190 | 166,777 | ||||||||||||||||||||||||
Issuance
of common stock in connection with the registration
statement
|
409,401 | 408 | 117,090 | 117,498 | ||||||||||||||||||||||||
Issuance
costs
|
(329,673 | ) | (329,673 | ) | ||||||||||||||||||||||||
Net
loss
|
(1,805,789 | ) | (1,805,789 | ) | ||||||||||||||||||||||||
Restatement
to reflect re- capitalization on Nov. 12, 2004 including cash paid of
$44,940
|
$ | (88,824 | ) | $ | (88,824 | ) | ||||||||||||||||||||||
Balance
at October 31, 2005
|
37,686,428 | $ | 37,686 | $ | 5,178,319 | $ | (3,464,430 | ) | $ | 1,751,575 | ||||||||||||||||||
Options
granted to consultants and professionals
|
172,831 | 172,831 | ||||||||||||||||||||||||||
Options
granted to employees and directors
|
71,667 | 71,667 | ||||||||||||||||||||||||||
Conversion
of debenture to Common Stock
|
1,766,902 | 1,767 | 298,233 | 300,000 |
Preferred Stock
|
Common Stock
|
|||||||||||||||||||||||||||
Number of
Shares
outstanding
|
Amount
|
Number of
Shares
outstanding
|
Amount
|
Paid-in
Additional
Capital
|
Deficit
Accumulated
During the
Development
Stage
|
Shareholders’
Equity
(Deficiency)
|
||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
229,422 | 229 | 54,629 | 54,858 | ||||||||||||||||||||||||
Issuance
of common stock to consultants
|
556,240 | 557 | 139,114 | 139,674 | ||||||||||||||||||||||||
Net
loss
|
(6,197,744 | ) | (6,197,744 | ) | ||||||||||||||||||||||||
40,238,992 | $ | 40,239 | $ | 5,914,793 | $ | (9,662,173 | ) | $ | (3,707,141 | ) | ||||||||||||||||||
Balance
at October 31, 2006
|
||||||||||||||||||||||||||||
Common
Stock issued
|
59,228,334 | 59,228 | 9,321,674 | 9,380,902 | ||||||||||||||||||||||||
Offering
Expenses
|
(2,243,535 | ) | (2,243,535 | ) | ||||||||||||||||||||||||
Options
granted to consultants and professionals
|
268,577 | 268,577 | ||||||||||||||||||||||||||
Options
granted to employees and directors
|
222,501 | 222,501 | ||||||||||||||||||||||||||
Conversion
of debenture to Common Stock
|
6,974,202 | 6,974 | 993,026 | 1,000,000 | ||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
416,448 | 416 | 73,384 | 73,800 | ||||||||||||||||||||||||
Issuance
of common stock to consultants
|
1,100,001 | 1,100 | 220,678 | 221,778 | ||||||||||||||||||||||||
Warrants
issued on conjunction with issuance of common stock
|
1,505,550 | 1,505,550 | ||||||||||||||||||||||||||
Net
loss
|
(2,454,453 | ) | (2,454,453 | ) | ||||||||||||||||||||||||
Balance
at October 31, 2007
|
107,957,977 | $ | 107,957 | $ | 16,276,648 | $ | (12,116,626 | ) | $ | 4,267,979 | ||||||||||||||||||
Common
Stock Penalty Shares
|
211,853 | 212 | 31,566 | 31,778 | ||||||||||||||||||||||||
Offering
Expenses
|
(78,013 | ) | (78,013 | ) | ||||||||||||||||||||||||
Options
granted to consultants and professionals
|
(42,306 | ) | (42,306 | ) | ||||||||||||||||||||||||
Options
granted to employees and directors
|
257,854 | 257,854 | ||||||||||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
995,844 | 996 | 85,005 | 86,001 | ||||||||||||||||||||||||
Issuance
of common stock to consultants
|
153,846 | 154 | 14,462 | 14,616 | ||||||||||||||||||||||||
Warrants
issued to consultant
|
39,198 | 39,198 | ||||||||||||||||||||||||||
Net
loss
|
||||||||||||||||||||||||||||
(5,416,418 | ) | (5,416,418 | ) | |||||||||||||||||||||||||
Balance
at October 31, 2008
|
109,319,520 | $ | 109,319 | $ | 16,584,414 | $ | (17,533,044 | ) | $ | (839,311 | ) |
Year Ended
October 31, 2008
|
Year Ended
October 31, 2007
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (5,416,418 | ) | $ | (2,454,453 | ) | $ | (17,489,160 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and stock
|
355,364 | 786,656 | 1,853,230 | |||||||||
Amortization
of deferred financing costs
|
- | 177,687 | 260,000 | |||||||||
Non-cash
interest expense
|
7,907 | 280,060 | 518,185 | |||||||||
(Gain)
Loss on charge in vale of warrants and embedded derivative
|
- | (1,159,846 | ) | 1,642,232 | ||||||||
Value
of penalty shares issued
|
31,778 | - | 149,276 | |||||||||
Depreciation
expense
|
36,137 | 31,512 | 92,090 | |||||||||
Amortization
expense of intangibles
|
161,208 | 54,577 | 313,511 | |||||||||
Gain
on note retirement
|
– | (1,532,477 | ) | (1,532,477 | ) | |||||||
(Increase)
decrease in prepaid expenses
|
161,055 | (161,817 | ) | (38,862 | ) | |||||||
Decrease
(increase) in other assets
|
- | 724 | (3,876 | ) | ||||||||
Increase
in accounts payable
|
211,559 | 99,076 | 1,436,062 | |||||||||
(Decrease)
increase in accrued expenses
|
298,322 | (217,444 | ) | 587,158 | ||||||||
(Decrease)
increase in interest payable
|
- | (117,951 | ) | 18,291 | ||||||||
(Decrease)
in Deferred Revenue
|
- | (20,350 | ) | - | ||||||||
Net
cash used in operating activities
|
(4,153,088 | ) | (4,234,046 | ) | (12,194,340 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
- | - | (44,940 | ) | ||||||||
Purchase
of property and equipment
|
(10,842 | ) | (37,632 | ) | (137,657 | ) | ||||||
Cost
of intangible assets
|
(200,470 | ) | (358,336 | ) | (1,525,860 | ) | ||||||
Net
cash used in Investing Activities
|
(211,312 | ) | (395,968 | ) | (1,708,457 | ) | ||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from (repayment of) convertible secured debenture
|
- | (2,040,000 | ) | 960,000 | ||||||||
Cash
paid for deferred financing costs
|
- | - | (260,000 | ) | ||||||||
Proceeds
from notes payable
|
475,000 | 600,000 | 1,746,224 | |||||||||
Payment
on notes payable
|
(14,832 | ) | (92,087 | ) | (106,919 | ) | ||||||
Net
proceeds of issuance of Preferred Stock
|
- | - | 235,000 | |||||||||
Payment
on notes payable
|
- | (600,000 | ) | (600,000 | ) | |||||||
Net
proceeds of issuance of Preferred Stock
|
(78,014 | ) | 8,042,917 | 11,988,230 | ||||||||
Net
cash provided by Financing Activities
|
382,154 | 5,910,830 | 13,962,535 | |||||||||
Net
increase in cash
|
(3,982,246 | ) | 1,280,816 | 59,738 | ||||||||
Cash
at beginning of period
|
4,041,984 | 2,761,166 | - | |||||||||
Cash
at end of period
|
$ | 59,738 | $ | 4,041,984 | $ | 59,738 |
Year Ended
October 31, 2008
|
Year Ended
October 31, 2007
|
Period from
March 1, 2002
(Inception) to
October 31, 2008
|
||||||||||
Equipment
acquired under notes payable
|
$ | - | $ | 45,580 | $ | 45,580 | ||||||
Common
Stock issued to Founders
|
$ | - | $ | $ | 40 | |||||||
Notes
payable and accrued interest converted to Preferred stock
|
$ | - | $ | $ | 15,969 | |||||||
Stock
dividend on Preferred Stock
|
$ | - | $ | $ | 43,884 | |||||||
Notes
payable and accrued interest converted to Common Stock
|
$ | - | $ | 1,600,000 | $ | 2,513,158 | ||||||
Intangible
assets acquired with notes payable
|
$ | - | $ | $ | 360,000 | |||||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$ | - | $ | $ | 512,865 | |||||||
Allocation
of the original secured convertible debentures to warrants
|
$ | - | $ | $ | 214,950 | |||||||
Warrants
issued in connection with issuance of Common Stock
|
$ | - | $ | 1,505,550 | $ | 1,505,550 |
1.
|
PRINCIPAL
BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES:
|
October 31, 2008
|
October 31, 2007
|
|||||||
Warrants
|
97,187,400 | 87,713,770 | ||||||
Stock
Options
|
8,812,841 | 8,512,841 | ||||||
Total
|
106,000,241 | 96,226,611 |
2.
|
SHARE-BASED
COMPENSATION EXPENSE
|
March 1, 2002
(date of inception)
to October 31,
2008
|
||||
Net
Loss as reported
|
$ | (17,489,160 | ) | |
Add:
Stock based option expense included in recorded net loss
|
89,217 | |||
Deduct
stock option compensation expense determined under fair value based
method
|
(328,176 | ) | ||
Adjusted
net Loss
|
$ | (17,728,119 | ) |
Year Ended
October 31,
2008
|
Year Ended
October 31,
2007
|
|||||||
Expected
volatility
|
110.1 | % | 119 | % | ||||
Expected
Life
|
5.9
years
|
7.0
years
|
||||||
Dividend
yield
|
0 | 0 | ||||||
Risk-free
interest rate
|
3.60 | % | 4.3 | % |
3.
|
INTANGIBLE
ASSETS:
|
October 31, 2008
|
October 31, 2007
|
||||||
Trademarks | - |
87,857
|
|||||
Patents
|
$ | 812,910 |
663,283
|
||||
License
|
529,915 |
496,127
|
|||||
Less:
Accumulated Amortization
|
(205,428 | ) |
(149,132
|
) | |||
$ | 1,137,397 | $ |
1,098,135
|
Year ending October 31,
|
||||
2009
|
$ | 70,000 | ||
2010
|
70,000 | |||
2011
|
70,000 | |||
2012
|
70,000 | |||
2013
|
70,000 |
4.
|
ACCRUED
EXPENSES:
|
October 31, 2008
|
October 31, 2007
|
||||||
Salaries
and other compensation
|
$ | 430,256 |
182,737
|
||||
Sponsored
Research Agreement
|
119,698 |
-
|
|||||
Consultants
|
24,000 |
84,619
|
|||||
Warrants
|
16,340 |
-
|
|||||
Clinical
Research Organization
|
11,166 |
37,667
|
|||||
Other
|
1,885 |
-
|
|||||
$ | 603,345 | $ |
305,023
|
5.
|
NOTES
PAYABLE:
|
October 31, 2008
|
October 31, 2007
|
||||||
Two
notes payable with interest at 8% per annum, due on December 17,
2008. The lender has served notice demanding repayment on the due
date pursuant to the November 2004 recapitalization and financing
agreement. The notes have not been paid as of January 29,
2009
|
$ | 69,588 |
65,577
|
||||
Notes
payable (Mr. Moore) with interest at 12% per annum compounded
quarterly
|
478,897 |
-
|
|||||
Installment
purchase agreement on equipment with interest at 11.75% per
annum
|
19,645 |
34,478
|
|||||
Total
|
568,130 |
100,055
|
|||||
Less
current portion
|
(563,317 | ) |
(80,409
|
) | |||
$ | 4,813 | $ |
19,646
|
6.
|
SECURED
CONVERTIBLE DEBENTURE:
|
Principal
$
|
Discount
$
|
Interest
$
|
Warrant
Liability
$
|
Embedded
Derivative
Liability
$
|
||||||||||||||||
Original
(Fiscal Year 2006)
|
3,000,000 | (727,815 | ) (1) | – | – | – | ||||||||||||||
Fiscal
year 2006
|
(300,000 | ) (2) | 230,218 | (3) | 119,934 | 714,600 | (4) | 2,815,293 | (4) | |||||||||||
Book
Value at October 31, 2006
|
2,700,000 | (497,597 | ) | 119,934 | 714,600 | 2,815,293 | ||||||||||||||
Fiscal
year 2007
|
(1,000,000 | ) (2) | 280,062 | (3) | 130,065 | 15,240 | (5) | (1,175,086 | ) (5) | |||||||||||
Cash
paid at October 17, 2007
|
(1,700,000 | ) | – | (249,999 | ) | (600,000 | ) | (340,000 | ) | |||||||||||
Gain
(Loss)
|
- | (217,535 | ) | – | 129,840 | 1,300,207 | ||||||||||||||
(1) Embedded
derivative’s warrant value at origination of debenture.
(2) Principal
converted into common stock.
(3) Amortized
discount to interest expense.
(4) Change
in fair value of the Company’s common stock warrants from inception
expensed to the statement of operations.
(5) Change
in fair value for fiscal 2007 until extinguishment.
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life In
Years
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
as of October 31, 2006
|
6,959,077 | $ | 0.25 | 8.1 | 18,867 | |||||||||||
Granted
|
2,910,001 | $ | 0.15 | - | ||||||||||||
Cancelled
or Expired
|
(1,356,237 | ) | $ | 0.22 | - | |||||||||||
Outstanding
as of October 31, 2007
|
8,512,841 | $ | 0.22 | 7.8 | 167,572 | |||||||||||
Granted
|
300,000 | $ | 0.09 | |||||||||||||
Exercised
|
- | - | - | |||||||||||||
Cancelled
or Expired
|
- | - | - | |||||||||||||
Outstanding
as of October 31, 2008
|
8,812,841 | $ | 0.22 | 6.3 | $ | - | ||||||||||
Vested
& Exercisable at October 31, 2008
|
7,399,563 | $ | 0.22 | 6.2 | $ | - |
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
|
|||||||||||||||||||||||
$ | 0.09-0.10 | 300 |
9.4
|
$ | 0.09 | $ | – | – | $ | – | $ | – | ||||||||||||||||||
0.14-0.17 | 3,150 |
8.1
|
0.15 | – | 2,519 | 0.15 | – | |||||||||||||||||||||||
0.18-0.21 | 1,739 |
5
|
0.21 | – | 1,705 | 0.21 | – | |||||||||||||||||||||||
0.22-0.25 | 310 |
7.5
|
0.25 | – | 173 | 0.24 | – | |||||||||||||||||||||||
0.26-0.29 | 2,992 |
6.6
|
0.28 | – | 2,681 | 0.28 | – | |||||||||||||||||||||||
0.30-0.43 | 322 |
4.3
|
0.37 | – | 322 | 0.37 | – | |||||||||||||||||||||||
Total | 8,813 |
6.3
|
$ | 0.22 | $ | – | 7,400 | $ | 0.22 | $ | – |
Number
of
Shares
|
Weighted
Average
Exercise
Price at
Grant
Date
|
Weighted
Average
Remaining
Contractual
Term
(in
years)
|
||||||||||
Non-vested
shares at October 31, 2006
|
3,203,167 | $ | 0.25 | 9.0 | ||||||||
Options
granted
|
2,910,001 | $ | 0.15 | 8.9 | ||||||||
Options
vested
|
(3,032,863 | ) | $ | 0.19 | 8.5 | |||||||
Non-vested
shares at October 31, 2007
|
3,080,305 | $ | 0.19 | 8.5 | ||||||||
Options
granted
|
300,000 | $ | 0.09 | 9.4 | ||||||||
Options
vested
|
(1,967,027 | ) | $ | 0.18 | 7.5 | |||||||
Non-vested
shares at October 31, 1008
|
1,413,278 | $ | 0.18 | 7.5 |
2008
|
2007
|
|||||||
Net
operating losses
|
$ | 6,611,401 |
3,736,212
|
|||||
Stock
based compensation
|
103,142 |
378,577
|
||||||
Less
valuation allowance
|
(6,714,543 | ) |
(4,114,729
|
) | ||||
Deferred
tax asset
|
$ | - |
-
|
Year ended
October 31,
2006
|
Year ended
October 31,
2007
|
Period from
March 1, 2002
(inception) to
October 31,
2008
|
||||||||||
Provision
at federal statutory rate
|
34 | % | 34 | % | 34 | % | ||||||
Valuation
allowance
|
(34 | ) | (34 | ) | (34 | ) | ||||||
- | % | - | % | - | % |
July
31, 2009
|
October
31,
|
|||||||
(unaudited)
|
2008
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
|
$ | 49,126 | $ | 59,738 | ||||
Prepaid
expenses
|
40,105 | 38,862 | ||||||
Total
Current Assets
|
89,231 | 98,600 | ||||||
Deferred
expenses
|
366,938 | – | ||||||
Property
and Equipment, net
|
63,661 | 91,147 | ||||||
Intangible
Assets, net
|
1,310,078 | 1,137,397 | ||||||
Other
Assets
|
3,876 | 3,876 | ||||||
Total
Assets
|
$ | 1,833,784 | $ | 1,331,020 | ||||
LIABILITIES
& SHAREHOLDERS’ DEFICIENCY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 1,362,832 | $ | 998,856 | ||||
Accrued
expenses
|
965,886 | 603,345 | ||||||
Convertible
Bridge Notes and fair value of embedded derivative
|
796,154 | – | ||||||
Notes
payable - current portion including interest payable
|
1,094,450 | 563,317 | ||||||
Total
Current Liabilities
|
4,219,322 | 2,165,518 | ||||||
Common
Stock Warrants
|
11,253,594 | – | ||||||
Notes
payable - net of current portion
|
- | 4,813 | ||||||
Total
Liabilities
|
$ | 15,472,916 | $ | 2,170,331 | ||||
Commitments
and Contingencies
|
||||||||
Shareholders’
Deficiency:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and
outstanding
|
– | – | ||||||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 115,638,243 as of July 31, 2009; and 109,319,520 as of October
31, 2008
|
115,637 | 109,319 | ||||||
Additional
Paid-In Capital
|
4,217,074 | 16,584,414 | ||||||
Deficit
accumulated during the development stage
|
(17,971,843 | ) | (17,533,044 | ) | ||||
Total
Shareholders’ Deficiency
|
$ | (13,639,132 | ) | $ | (839,311 | ) | ||
Total
Liabilities & Shareholders’ Deficiency
|
$ | 1,833,784 | $ | 1,331,020 |
|
9 Months
Ended
July 31,
2009
|
9 Months
Ended
July 31,
2008
|
Period from
March 1,
2002
(Inception)
to July 31,
2009
|
|||||||||
Revenue
|
$ | (5,369 | ) | $ | 68,404 | $ | 1,319,803 | |||||
Research
& Development Expenses
|
939,407 | 2,004,324 | 8,797,391 | |||||||||
General
& Administrative Expenses
|
2,019,648 | 2,349,439 | 12,028,215 | |||||||||
Total
Operating expenses
|
2,959,055 | 4,353,763 | 20,825,606 | |||||||||
Loss
from Operations
|
(2,964,424 | ) | (4,285,359 | ) | (19,505,803 | ) | ||||||
Other
Income (expense):
|
||||||||||||
Interest
expense
|
(410,615 | ) | (5,705 | ) | (1,495,098 | ) | ||||||
Other
Income
|
46,427 | 246,457 | ||||||||||
Gain
on note retirement
|
– | – | 1,532,477 | |||||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
2,014,220 | – | 371,988 | |||||||||
Net
income (loss) before benefit for income tax benefit
|
(1,360,819 | ) | (4,244,637 | ) | (18,849,979 | ) | ||||||
Income
tax benefit
|
922,020 | – | 922,020 | |||||||||
Net
income (loss)
|
(438,799 | ) | (4,244,637 | ) | (17,927,959 | ) | ||||||
Dividends
attributable to preferred shares
|
– | – | 43,884 | |||||||||
Net
income (loss) applicable to common Stock
|
$ | (438,799 | ) | $ | (4,244,637 | ) | $ | (17,971,843 | ) | |||
Net
income (loss) per share, basic
|
$ | 0.00 | $ | (0.04 | ) | |||||||
Net
income (loss) per share, diluted
|
$ | 0.00 | $ | (0.04 | ) | |||||||
Weighted
average number of shares outstanding, basic
|
112,599,706 | 108,513,191 | ||||||||||
Weighted
average number of shares outstanding, diluted
|
112,599,706 | 108,513,191 |
9
Months
ended
July 31,
2009
|
9
Months
ended
July 31,
2008
|
Period
from
March
1, 2002
(Inception)
to
July
31, 2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (438,799 | ) | $ | (4,244,637 | ) | $ | (17,927,959 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Non-cash
charges to consultants and employees for options and stock
|
372,695 | 311,806 | 2,225,925 | |||||||||
Amortization
of deferred financing costs
|
– | – | 260,000 | |||||||||
Amortization
of Discount on bridge Loan
|
37,231 | – | 37,321 | |||||||||
Non-cash
interest expense
|
345,044 | 3,002 | 863,229 | |||||||||
Change
in value of warrants and embedded derivative
|
(2,014,218 | ) | – | (371,988 | ) | |||||||
Value
of penalty shares issued
|
– | 31,778 | 149,276 | |||||||||
Depreciation
expense
|
27,486 | 26,975 | 119,576 | |||||||||
Amortization
expense of intangibles
|
54,374 | 51,795 | 367,885 | |||||||||
Gain
on note retirement
|
– | – | (1,532,477 | ) | ||||||||
(Increase)
Decrease in prepaid expenses
|
(1,243 | ) | 94,711 | (40,105 | ) | |||||||
Increase
in other assets
|
– | – | (3,876 | ) | ||||||||
Increase
in Deferred expenses
|
(116,938 | ) | – | (116,938 | ) | |||||||
Increase
in accounts payable
|
415,954 | 113,162 | 1,852,016 | |||||||||
Increase
in accrued expenses
|
112,541 | 101,781 | 699,699 | |||||||||
Accrued
interest on notes payable
|
– | – | 18,291 | |||||||||
Increase
in deferred revenue
|
– | 6,596 | – | |||||||||
Net
cash used in Operating Activities
|
(1,205,873 | ) | (3,503,031 | ) | (13,400,123 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Cash
paid on acquisition of Great Expectations
|
– | – | (44,940 | ) | ||||||||
Purchase
of property and equipment
|
– | (10,842 | ) | (137,657 | ) | |||||||
Cost
of intangible assets
|
(227,054 | ) | (178,542 | ) | (1,752,914 | ) | ||||||
Net
cash used in Investing Activities
|
(227,054 | ) | (189,384 | ) | (1,935,511 | ) | ||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from convertible secured debenture
|
– | – | 960,000 | |||||||||
Cash
paid for deferred financing costs
|
(260,000 | ) | ||||||||||
Principal
payment on notes payable
|
(12,320 | ) | (10,960 | ) | (119,239 | ) | ||||||
Proceeds
from notes payable
|
– | – | 1,271,224 | |||||||||
Proceeds
from notes payable
|
1,434,635 | – | 1,909,635 | |||||||||
Net
proceeds of issuance of Preferred Stock
|
– | – | 235,000 | |||||||||
Payment
on cancellation of warrants
|
– | – | (600,000 | ) | ||||||||
Proceeds
of issuance of Common Stock; net of issuance costs
|
– | (78,013 | ) | 11,988,230 | ||||||||
Net
cash provided by (used in) Financing Activities
|
$ | 1,422,315 | $ | (88,973 | ) | $ | 15,384,850 | |||||
Net
(Decrease) Increase in cash
|
(10,612 | ) | (3,781,388 | ) | 49,216 | |||||||
Cash
at beginning of period
|
59,738 | 4,041,984 | – | |||||||||
Cash
at end of period
|
$ | 49,126 | $ | 260,596 | $ | 49,216 |
9
Months
ended
July 31,
2009
|
9
Months
ended
July 31,
2008
|
Period
from
March
1, 2002
(Inception)
to
July
31, 2009
|
||||||||||
Equipment
acquired under capital lease
|
$ | – | $ | – | $ | 45,580 | ||||||
Common
Stock issued to Founders
|
$ | – | $ | – | $ | 40 | ||||||
Notes
payable and accrued interest converted to Preferred Stock
|
$ | – | $ | – | $ | 15,969 | ||||||
Stock
dividend on Preferred Stock
|
$ | – | $ | – | $ | 43,884 | ||||||
Accounts
payable from consultants settled with common stock
|
$ | 51,978 | $ | 51,978 | ||||||||
Notes
payable and accrued interest converted to Common Stock
|
$ | – | $ | – | $ | 2,513,158 | ||||||
Intangible
assets acquired with notes payable
|
$ | – | $ | – | $ | 360,000 | ||||||
D
Debt discount in connection with recording the original value of the
embedded derivative liability
|
$ | 1,023,116 | $ | – | $ | 1,535,912 | ||||||
Allocation
of the original secured convertible debentures to warrants
|
$ | – | $ | – | $ | 214,950 | ||||||
Allocation
of the Warrant on Bridge Loan as debt discount
|
$ | 250,392 | $ | 250,392 | ||||||||
Warrants
issued in connection with issuances of common stock
|
$ | – | $ | – | $ | 1,505,550 | ||||||
Warrants
recorded as a liability
|
$ | 12,785,695 | $ | – | $ | 12,785,695 |
July
31, 2009
|
October
31, 2008
|
Increase/
(Decrease)
|
||||||||||
License
|
$ | 571,275 | $ | 529,915 | $ | 41,360 | ||||||
Patents
|
998,605 | 812,910 | 185,695 | |||||||||
Total
intangibles
|
1,569,880 | 1,342,825 | 227,055 | |||||||||
Accumulated
Amortization
|
(259,802 | ) | (205,428 | ) | (54,374 | ) | ||||||
Intangible
Assets
|
$ | 1,310,078 | $ | 1,137,397 | $ | 172,681 |
As
of
July
31, 2009
|
As
of
July
31, 2008
|
|||||||
Warrants
|
89,143,801 | 94,149,587 | ||||||
Stock
Options
|
17,962,841 | 8,812,841 | ||||||
Total
All
|
107,106,642 | 102,962,428 |
6.
|
Derivative
Instruments
|
|
(i)
|
$0.20
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 312.32%, Life 145 to 1825 days, warrants outstanding
89,143,801.
|
|
(ii)
|
$0.135
exercise price, market price $0.11, risk free interest 0.28% to 2.86%,
volatility 170.16% to 312.32%, Life 145 to 1825 days warrants outstanding
123,269,393
|
|
(iii)
|
$0.055
exercise price, market price $0.11, risk free interest 1.00% to 2.86%,
volatility 170.16% to 312.32%, Life 620 to 1825 days, warrants outstanding
202,416,414
|
|
(i)
|
$0.20
exercise price, market price $0.09, risk free interest 0.18% to 2.53%,
volatility 170.16% to 294.68%, Life 102 to 1782 days warrants outstanding
89,143,801.
|
|
(ii)
|
$0.135
exercise price, market price $0.09, risk free interest 0.18% to 2.53%,
volatility 170.16% to 294.68%, Life 102 to 1782 days, warrants outstanding
123,269,393
|
|
(iii)
|
$0.055
exercise price, market price $0.09, risk free interest 0.8% to 2.53%,
volatility 170.16% to 294.68%, Life 579 to 1782 days warrants outstanding
244,073,417
|
|
·
|
$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) .
|
7.
|
Accounting
for Stock-Based Compensation Plans
|
For the nine
month period
ended July 31,
2009
|
For the nine
month period
ended July 31,
2008
|
|||||||
Research
and development
|
143,486 | 474 | ||||||
General
and Administrative
|
202,984 | 157,009 | ||||||
Total
stock compensation expense recognized
|
$ | 346,470 | $ | 157,483 |
8.
|
Commitments
and Contingencies
|
9.
|
Shareholders
Equity
|
Additional Paid-In Capital:
|
||||
Balance
as of October 31, 2008:
|
$ | 16,584,414 | ||
Warrants
converted into common stock
|
( 3,300 | ) | ||
Common
stock issued to consultants
|
67,140 | |||
Stock
options granted to employees and consultants
|
354,515 | |||
Warrant
Liability recorded at inception
|
(12,785,695 | ) | ||
Balance
as of July 31, 2009
|
$ | 4,217,074 |
10.
|
Subsequent
Events
|
SEC
registration fee
|
$ | 376.65 | ||
Blue
sky fees and expenses
|
2,000.00 | |||
Printing
and engraving expenses
|
6,000.00 | |||
Legal
fees and expenses
|
35,000.00 | |||
Accounting
fees and expenses
|
10,000.00 | |||
Transfer
agent and registrar’s fees and expenses
|
3,000.00 | |||
Miscellaneous
expense
|
623.35 | |||
Total
|
$ | 57,000.00 |
Exhibit
Number
|
Description of
Exhibit
|
|
2.1
|
Agreement
Plan and Merger of Advaxis, Inc. (a Colorado corporation) and Advaxis,
Inc. (a Delaware corporation). Incorporated by reference to
Annex B to DEF 14A Proxy Statement filed with the SEC on May 15,
2006.
|
|
3.1(i)
|
Amended
and Restated Articles of Incorporation. Incorporated by
reference to Annex C to DEF 14A Proxy Statement filed with the SEC on May
15, 2006.
|
|
3.1(ii)
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 10.4
to Quarterly Report on Form 10-QSB filed with the SEC on September 13,
2006.
|
|
4.1
|
Form
of common stock certificate. Incorporated by reference to
Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on October
23, 2007.
|
|
4.2
|
Form
of warrant to purchase shares of the registrant’s common stock at the
price of $0.20 per share (the “$0.20 Warrant”). Incorporated by
reference to Exhibit 4.2 to Current Report on Form 8-K filed with the SEC
on October 23, 2007.
|
|
4.3
|
Form
of warrant to purchase shares of the registrant’s common stock at the
price of $0.001 per share (the “$.001 Warrant”). Incorporated
by reference to Exhibit 4.3 to Current Report on Form 8-K filed with the
SEC on October 23, 2007.
|
|
4.4
|
Form
of warrant issued in the August 2007 financing. Incorporated by
reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC
on August 27, 2007.
|
|
4.5
|
Form
of note issued in the August 2007 financing. Incorporated by
reference to Exhibit 10.2 to Current Report on Form 8-K filed with the SEC
on August 27, 2007.
|
|
4.6
|
Form
of Common Stock Purchase Warrant. Incorporated by reference to Exhibit 4.1
to Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
4.7
|
Form
of Senior Secured Convertible Note. Incorporated by reference to Exhibit
4.2 to Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
4.8
|
Form
of Senior Promissory Note as Amended, between the registrant and Thomas
Moore. Incorporated by reference to Exhibit 4.3 to Current Report on Form
8-K filed with the SEC on June 19, 2009.
|
|
4.9
|
Certificate
of Designations of Preferences, Rights and Limitations of Series A
Preferred Stock of the registrant, dated September 24, 2009. Incorporated
by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the
SEC on September 25, 2009.
|
|
4.10 |
Promissory
Note issued to Biotechnology Greenhouse Corporation of Southeastern
Pennsylvania, dated November 10, 2003. Incorporated by
reference to Exhibit 10.53 to Annual Report on Form 10-KSB filed with the
SEC on January 29, 2009.
|
|
4.11 |
Promissory
Note issued to Biotechnology Greenhouse Corporation of Southeastern
Pennsylvania, dated December 17, 2003. Incorporated
by reference to Exhibit 10.54 to Annual Report on Form 10-KSB filed with
the SEC on January 29, 2009.
|
|
4.12**
|
Form
of Common Stock Purchase Warrant, issued in the October 2009 bridge
financing.
|
|
4.13**
|
Form
of Convertible Promissory Note, issued in the October 2009 bridge
financing.
|
|
5.1**
|
Opinion
of Greenberg Traurig, LLP.
|
|
10.1
|
Securities
Purchase Agreement between the registrant and the purchasers in the
private placement (the “SPA”), dated as of October 17, 2007, and
Disclosure Schedules thereto. Incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on October
23, 2007.
|
|
10.2
|
Securities
Purchase Agreement dated February 2, 2006 between the registrant and
Cornell Capital Partners, LP. Incorporated by reference to
Exhibit 10.01 to Report on Form 8-K filed with the SEC on February 8,
2006.
|
Exhibit
Number
|
Description of Exhibit
|
|
10.3
|
Registration
Rights Agreement between the registrant and the parties to the SPA, dated
as of October 17, 2007. Incorporated by reference to Exhibit
10.2 to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.4
|
Placement
Agency Agreement between the registrant and Carter Securities, LLC, dated
as of October 17, 2007. Incorporated by reference to Exhibit
10.3 to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.5
|
Engagement
Letter between the registrant and Carter Securities, LLC, dated August 15,
2007. Incorporated by reference to Exhibit 10.3(a) to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.6
|
Agreement
between the registrant and YA Global Investments, L.P. f/k/a Cornell
Capital Partners, L.P., dated August 23, 2007. Incorporated by
reference to Exhibit 10.4 to Current Report on Form 8-K filed with the SEC
on October 23, 2007.
|
|
10.7
|
Memorandum
of Agreement between the registrant and CAMHZN Master LDC and CAMOFI
Master LDC, purchasers of the Units consisting of common stock, $0.20
warrants, and $0.001 warrants, dated October 17,
2007. Incorporated by reference to Exhibit 10.5 to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.8
|
Advisory
Agreement between the registrant and Centrecourt Asset Management LLC,
dated August 1, 2007. Incorporated by reference to Exhibit 10.6
to Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
10.9
|
Share
Exchange and Reorganization Agreement, dated as of August 25, 2004, by and
among the registrant, Advaxis and the shareholders of
Advaxis. Incorporated by reference to Exhibit 10.1 to Current
Report on Form 8-K filed with the SEC on November 18,
2004.
|
|
10.10
|
Security
Agreement dated February 2, 2006 between the registrant and Cornell
Capital Partners, L.P. Incorporated by reference to Exhibit
10.06 to Current Report on Form 8-K filed with the SEC on February 8,
2006.
|
|
10.11
|
Investor
Registration Rights Agreement dated February 2, 2006 between the
registrant and Cornell Capital Partners, LP. Incorporated by
reference to Exhibit 10.05 to Current Report on Form 8-K filed with the
SEC on February 8, 2006.
|
|
10.12
|
2004
Stock Option Plan of the registrant. Incorporated by reference
to Exhibit 4.1 to Report on Form S-8 filed with the SEC on December 1,
2005.
|
|
10.13
|
2005
Stock Option Plan of the registrant. Incorporated by reference
to Annex A to DEF 14A Proxy Statement filed with the SEC on May 15,
2006.
|
|
10.14
|
License
Agreement, between University of Pennsylvania and the registrant dated as
of June 17, 2002, as Amended and Restated on February 13,
2007. Incorporated by reference to Exhibit 10.11 to Annual
Report on From 10-KSB filed with the SEC on February 13,
2007.
|
|
10.15
|
Sponsored
Research Agreement dated November 1, 2006 by and between University of
Pennsylvania (Dr. Paterson Principal Investigator) and the
registrant. Incorporated by reference to Exhibit 10.44 to
Annual Report on 10-KSB filed with the SEC on February 13,
2007.
|
|
10.16
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004, between The Regents of
the University of California and Advaxis, Inc. Incorporated by
reference to Exhibit 10.8 to Pre-Effective Amendment No. 2 filed on April
28, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
Number
|
Description of Exhibit
|
|
10.17
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the registrant. Incorporated by reference
to Exhibit 10.9 to Pre-Effective Amendment No. 2 filed on April 28, 2005
to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.18
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 10.27 to Annual Report on Form 10-KSB filed with the SEC on
January 25, 2006.
|
|
10.19
|
Second
Amendment dated October 31, 2005 to Consultancy Agreement between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 10.2 to Current Report on Form 8-K filed with the SEC on November
9, 2005.
|
|
10.20
|
Third
Amendment dated December 15, 2006 to Consultancy Agreement between LVEP
Management LLC and the registrant. Incorporated by reference to
Exhibit 9.01 to Current Report on Form 8-K filed with the SEC on December
15, 2006.
|
|
10.21
|
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. Incorporated by reference to Exhibit
10.12 to Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.22
|
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A. Cavagnaro
and Advaxis, Inc. Incorporated by reference to Exhibit 10.13 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.23
|
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc. Incorporated by reference to
Exhibit 10.15 to Pre-Effective Amendment No. 2 filed on April 28, 2005 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.24
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and Advaxis,
Inc. Incorporated by reference to Exhibit 10.16 to
Pre-Effective Amendment No. 4 filed on June 9, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.25
|
Securities
Purchase Agreement, dated as of January 12, 2005, by and between the
registrant and Harvest Advaxis LLC. Incorporated by reference
to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on
January 18, 2005.
|
|
10.26
|
Registration
Rights Agreement, dated as of January 12, 2005, by and between the
registrant and Harvest Advaxis LLC. Incorporated by reference
to Exhibit 10.2 to Current Report on Form 8-K filed with the SEC on
January 18, 2005.
|
|
10.27
|
Letter
Agreement, dated as of January 12, 2005 by and between the registrant and
Robert T. Harvey. Incorporated by reference to
Exhibit 10.3 to Current Report on Form 8-K filed with the SEC on January
18, 2005.
|
|
10.28
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David Filer
and the registrant. Incorporated by reference to Exhibit 10.20
to Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.29
|
Consulting
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the registrant. Incorporated by
reference to Exhibit 10.21 to Pre-Effective Amendment No. 2 filed on April
28, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.30
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman and the
registrant. Incorporated by reference to Exhibit 10.23 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.31
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and the
registrant. Incorporated by reference to Exhibit 10.24 to
Pre-Effective Amendment No. 2 filed on April 28, 2005 to Registration
Statement on Form SB-2 (File No.
333-122504).
|
Exhibit
Number
|
Description of Exhibit
|
|
10.32
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
registrant. Incorporated by reference to Exhibit 10.25 to
Pre-Effective Amendment No. 2 filed on April 8, 2005 to Registration
Statement on Form SB-2/A (File No. 333-122504).
|
|
10.33
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the registrant. Incorporated by
reference to Exhibit 10.26 to Pre-Effective Amendment No. 4 filed on June
9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.34
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the registrant. Incorporated by
reference to Exhibit 10.28 to Pre-Effective Amendment No. 4 filed on June
9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
10.35
|
Letter
Agreement between the registrant and Investors Relations Group Inc., dated
September 27, 2005. Incorporated by reference to Exhibit 10.31
to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.36
|
Consultancy
Agreement between the registrant and Freemind Group LLC, dated October 17,
2005. Incorporated by reference to Exhibit 10.32 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
10.37
|
Employment
Agreement dated August 21, 2007 between the registrant and Thomas
Moore. Incorporated by reference to Exhibit 10.3 to Current
Report on Form 8-K filed with the SEC on August 27,
2007.
|
|
10.38
|
Employment
Agreement dated February 9, 2006 between the registrant and Fred
Cobb. Incorporated by reference to Exhibit 10.35 to the
Registration Statement on Form SB-2 (File No. 333-132298) filed with the
SEC on March 9, 2006.
|
|
10.39
|
Termination
of Employment Agreement between J. Todd Derbin and the registrant dated
October 31, 2005. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on November 9,
2005.
|
|
10.40
|
Consulting
Agreement dated June 1, 2006 between the registrant and Biologics
Consulting Group Inc. Incorporated by reference to Exhibit
10.40 to Annual Report on Form 10-KSB field with the SEC on February 13,
2007.
|
|
10.41
|
Consulting
Agreement dated June 1, 2006 between the registrant and Biologics
Consulting Group Inc., as amended on June 1, 2007. Incorporated
by reference to Exhibit 10.42(i) to Annual Report on Form 10-KSB filed
with the SEC on January 16, 2008.
|
|
10.42
|
Master
Contract Service Agreement between the registrant and MediVector, Inc.
dated May 20, 2007. Incorporated by reference to Exhibit 10.44 to Annual
Report on Form 10-KSB filed with the SEC on January 16,
2008.
|
|
10.43
|
Letter
of Agreement, dated November 21, 2007, between Crystal Research
Associates, LLC and the registrant. Incorporated by reference to Exhibit
10.45 to Annual Report on Form 10-KSB filed with the SEC on January 16,
2008.
|
|
10.44
|
Service
Proposal O781, dated May 14, 2007, to the Strategic Collaboration and
Long Term Vaccine Supply Agreement, dated October 31, 2005, between the
registrant and Cobra Biomanufacturing Plc. Incorporated by reference to
Exhibit 10.46 to Annual Report on Form 10-KSB filed with the SEC on
January 16, 2008.
|
|
10.45
|
Service
Proposal, dated September 20, 2007, to the Strategic Collaboration
and Long Term Vaccine Supply Agreement, dated October 31, 2005, between
the registrant and Cobra Biomanufacturing Plc. Incorporated by reference
to Exhibit 10.47 to Annual Report on Form 10-KSB filed with the SEC on
January 16, 2008.
|
Exhibit
Number
|
Description of Exhibit
|
|
10.46
|
Consulting
Agreement, dated May 1, 2007 between the registrant and Bridge Ventures,
Inc. Incorporated by reference to Exhibit 10.48 to Annual Report on Form
10-KSB filed with the SEC on January 16, 2008.
|
|
10.47
|
Consulting
Agreement, dated August 1, 2007 between the Company and Dr. David Filer.
Incorporated by reference to Exhibit 10.49 to Annual Report on Form 10-KSB
filed with the SEC on January 16, 2008.
|
|
10.48
|
Employment
Agreement dated February 29, 2008 between the registrant and Christine
Chansky. Incorporated by reference to Exhibit 10.50 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.49
|
Note
Purchase Agreement, dated September 22, 2008 by and between Thomas A.
Moore and the registrant. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on September 30,
2008.
|
|
10.50
|
Lease
Extension Agreement dated June 1, 2008 by and between New Jersey Economic
Development Authority and the registrant. Incorporated by reference to
Exhibit 10.55 to Annual Report on Form 10-KSB filed with the SEC on
January 29, 2009.
|
|
10.51
|
Technical/Quality
Agreement dated May 6, 2008 by and between Vibalogics GmbH and the
registrant. Incorporated by reference to Exhibit 10.57 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.52
|
Master
Service Agreement dated April 7, 2008 by and between Vibalogics GmbH and
the registrant. Incorporated by reference to Exhibit 10.58 to Annual
Report on Form 10-KSB filed with the SEC on January 29,
2009.
|
|
10.53
|
Agreement,
dated as of December 8, 2008, by and between The Sage Group and the
registrant. Incorporated by reference to Exhibit 10.59 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.54
|
Service
Agreement dated January 1, 2009 by and between AlphaStaff, Inc. and the
registrant. Incorporated by reference to Exhibit 10.60 to Annual Report on
Form 10-KSB filed with the SEC on January 29,
2009.
|
Exhibit
Number
|
Description of
Exhibit
|
|
10.55
|
Letter
of Intent dated November 20, 2008 by and between Numoda Corporation and
the registrant. Incorporated by reference to Exhibit 10.61 to Annual
Report on Form 10-KSB filed with the SEC on January 29,
2009.
|
|
10.56
|
Consulting
Agreement dated December 1, 2008 by and between Conrad Mir and the
registrant. Incorporated by reference to Exhibit 10.62 to Annual Report on
Form 10-KSB filed with the SEC on January 29, 2009.
|
|
10.57
|
Form
of Note Purchase Agreement. Incorporated by reference to Exhibit 10.1 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.58
|
Form
of Security Agreement. Incorporated by reference to Exhibit 10.2 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.59
|
Form
of Subordination Agreement. Incorporated by reference to Exhibit 10.3 to
Current Report on Form 8-K filed with the SEC on June 19,
2009.
|
|
10.60
|
Preferred
Stock Purchase Agreement dated September 24, 2009 by and between Optimus
Capital Partners, LLC and the registrant. Incorporated by reference to
Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on September
25, 2009.
|
|
10.61**
|
Form
of Note Purchase Agreement, entered into in connection with the October
2009 bridge financing.
|
|
14.1
|
Code
of Business Conduct and Ethics dated November 12,
2004. Incorporated by reference to Exhibit 14.1 to Current
Report on Form 8-K filed with the SEC on November 18,
2004.
|
|
23.1*
|
Consent
of McGladrey & Pullen, LLP.
|
|
23.2*
|
Consent
of Goldstein Golub Kessler LLP
|
|
23.3
|
Consent
of Greenberg Traurig LLP (See Exhibit 5.1 above).
|
|
24.1
|
|
Power
of Attorney (Included in the signature page of the initial filing of this
Registration Statement on Form S-1, filed with the SEC on October 22,
2009).
|
ADVAXIS, INC. | ||
By:
|
/S/
THOMAS A. MOORE
|
|
|
Name:
Thomas A. Moore
|
|
|
Title:
Chief Executive Officer and Chairman of
the
Board of
Directors
|
Signature
|
Title
|
Date
|
||
/S/ THOMAS A. MOORE
|
Chief
Executive Officer and Chairman of
the
Board of Directors
|
November
6, 2009
|
||
Thomas
A. Moore
|
(Principal
Executive Officer)
|
|||
/S/ FREDRICK D. COBB
|
Vice
President, Finance
|
November
6, 2009
|
||
Fredrick
D. Cobb
|
(Principal
Financial and Accounting Officer)
|
|||
*
|
Director
|
November
6, 2009
|
||
Roni
A. Appel
|
||||
*
|
Director
|
November
6, 2009
|
||
Dr.
Thomas McKearn
|
||||
*
|
Director
|
November
6, 2009
|
||
Dr.
James Patton
|
||||
*
|
|
Director
|
|
November
6, 2009
|
Richard
Berman
|
/S/
THOMAS A. MOORE
|
|
Thomas
A. Moore
|