ADVAXIS,
INC.
NOTES
TO FINANCIAL STATEMENTS
1.
Business description
We
are a
development stage biotechnology company utilizing multiple mechanisms of
immunity with the intent to develop cancer vaccines that are more effective
and
safer than existing vaccines. To that end, we have licensed rights from the
University of Pennsylvania (“Penn”) to use a patented system to engineer a live
attenuated Listeria monocytogenes bacteria (the “Listeria System”) to secrete a
protein sequence containing a tumor-specific antigen. Using the Listeria
System,
we believe we will force the body’s immune system to process and recognize the
antigen as if it were foreign, creating the immune response needed to attack
the
cancer. Our licensed Listeria System, developed at Penn over the past 10
years,
provides a scientific basis for believing that this therapeutic approach
induces
a significant immune response to a tumor. Accordingly, we believe that the
Listeria System is a broadly enabling platform technology that can be applied
to
many types of cancers. In addition, we believe there may be useful applications
in infectious diseases and auto-immune disorders. The therapeutic approach
that
comprises the Listeria System is based upon the innovative work of Yvonne
Paterson, Ph.D., Professor of Microbiology at Penn, involving the creation
of
genetically engineered Listeria that stimulate the innate immune system and
induce an antigen-specific immune response involving humoral and cellular
components. We have obtained an exclusive 20-year license from Penn to exploit
the Listeria System, subject to meeting various royalty and other obligations
(the “Penn License”).
The
interim financial statements include all adjustments which, in the opinion
of
management, are necessary to make the financial statements not
misleading.
2.
Option
expenses
The
Company has elected to apply APB opinion No. 25 and related interpretations
in
accounting for its stock option granted to employees and has adopted the
disclosure only provisions of SFAS No. 123. Had the Company elected to recognize
compensation cost based on the fair value of the options granted at the grant
date as prescribed by SFAS No. 123, the Company’s net loss would have been as
follows:
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3
Months ended
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|
3
Months ended
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9
Months ended
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9
Months ended
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July
31,
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|
July
31,
|
|
July
31,
|
|
July
31,
|
|
|
|
2005
|
|
2004
|
|
2005
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss as reported
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|
$
|
(388,604
|
)
|
$
|
(163,962
|
)
|
$
|
(1,347,465
|
)
|
$
|
(574,202
|
)
|
Add:
Stock based compensation expense included in recorded net
income
|
|
|
20,748
|
|
|
|
|
|
42,527
|
|
|
8,484
|
|
Less:
Deduct stock option compensation expense determined under fair
value based
method
|
|
|
(52,701
|
)
|
|
(12,546
|
)
|
|
(136,702
|
)
|
|
(62,014
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted
Net Loss
|
|
|
(420,557
|
)
|
$
|
(176,508
|
)
|
$
|
(1,441,640
|
)
|
$
|
(627,732
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss per share as reported
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
Net
Loss per share pro forma
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
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The
Company accounts for non-employee stock based awards in which goods or services
are the consideration received for the equity instrument issued based on
the
fair value of the equity instrument in accordance with the guidance provided
in
the consensus opinion of the Emerging Issues Task Force (“EITF”) issue 96-18,
Accounting
for Equity Instruments that are Issued to Other than Employees for Acquiring,
or
in Conjunction with Selling Goods or Services.
3.
Recapitalization and financing
In
November 2004, we acquired 100% of the stock of Advaxis. Advaxis was organized
in 2002 to develop the Listeria System under patents licensed from Penn which
are described above under “General” and later in this prospectus under
“Business.”
We
acquired Advaxis through a share exchange and reorganization (the
“Recapitalization”), pursuant to which Advaxis became our wholly owned
subsidiary. We acquired (i) all of the issued and outstanding shares of
Advaxis’s common stock and Advaxis’s Series A preferred stock in exchange for an
aggregate of 15,597,723 shares of authorized, but theretofore unissued, shares
of our common stock, no par value, (ii) all of the issued and outstanding
warrants to purchase Advaxis’s common stock, in exchange for warrants to
purchase 584,885 of our shares; and (iii) all of the issued and outstanding
options to purchase the common stock of Advaxis in exchange for an aggregate
of
2,381,525 options to purchase our common stock, constituting approximately
96%
of our common stock prior to the issuance of shares of our common stock in
the
private placement described below. Prior to the closing of the Recapitalization,
we performed a 200-for-1 reverse stock split, thus reducing the issued and
outstanding shares of our common stock from 150,520,000 shares to 752,600
shares. Additionally, 752,600 shares of our common stock were issued to the
financial advisor in connection with the Recapitalization. Pursuant to the
Recapitalization, there are 17,102,923 of our common shares issued and
outstanding.
As
a
result of the transaction, the former shareholders of Advaxis are our
controlling shareholders. Additionally, prior to the transaction, we had
no
substantial assets. Accordingly, the transaction is treated as a reverse
acquisition of a public shell, and the transaction has been accounted for
as a
recapitalization of Advaxis, rather than a business combination. The historical
financial statements of Advaxis are now our historical financial statements.
Historical shareholders’ equity (deficiency) of Advaxis has been restated to
reflect the recapitalization, and include the shares received in the
transaction.
On
November 12, 2004, we completed an initial closing of a private placement
offering (the “Private Placement”), whereby we sold an aggregate of $2.925
million worth
of
units to accredited investors. Each unit was sold for $25,000 (the “Unit Price”)
and consisted of (a) 87,108 shares of common stock and (b) a warrant to
purchase, at any time prior to the fifth anniversary following the date of
issuance of the warrant, to purchase 87,108 shares of common stock included
at a
price equal to $0.40 per share of common stock (a “Unit”). In consideration of
the investment, we granted to each investor certain registration rights and
anti-dilution rights. Also, in November 2004, we converted approximately
$618,000 of aggregate principal promissory notes and accrued interest
outstanding into Units.
On
December 8, 2004, we completed a second closing of the Private Placement,
whereby we sold an aggregate of $200,000 of Units to accredited
investors.
On
January 4, 2005, we completed a third and final closing of the Private
Placement, whereby we sold an aggregate of $128,000 of Units to accredited
investors.
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by
and
between us and Sunrise Securities, Corp. (the “Placement Agent”), we issued to
the Placement Agent and its designees an aggregate of 2,283,445 shares of
common
stock and warrants to purchase up to an aggregate of 2,666,900 shares of
common
stock. The shares were issued as part consideration for the services of the
Placement Agent, as our placement agent in the Private Placement. In addition,
we paid the Placement Agent a total cash fee of $50,530.
On
January 12, 2005, we completed a second private placement offering whereby
we
sold an aggregate of $1,100,000 of units to a single investor. As with the
Private Placement, each unit issued and sold in this subsequent private
placement was sold at $25,000 per unit and is comprised of (i) 87,108 shares
of
our common stock, and (ii) a five-year warrant to purchase 87,108 shares
of our
common stock at an exercise price of $0.40 per share. Upon the closing of
this
second private placement offering we issued to the investor 3,832,753 shares
of
common stock and warrants to purchase up to an aggregate of 3,832,753 shares
of
common stock.
The
aggregate sale from the four private placements was $4,353,000, which was
netted
against transaction costs of $329,673 for net proceeds of
$4,023,327.
Between
February 1, 2005 and July 31, 2005 we issued 400,635 common shares in exchange
for services. In addition, we issued 156,794 common shares to our Chief
Executive Officer as a bonus for year 2004. We also issued 409,401 common
shares
to our investors as penalty shares pursuant to the terms of the Private
Placement.
As
a
result of these transactions the total number of issued and outstanding common
shares as of July 31, 2005 was 37,656,886.
We
are
obligated to issue, but have not yet issued, 14,000 shares to a consultant
for
services rendered in the period.
Item
2. Plan of Operations
The
Company has included in this Quarterly Report certain “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995 concerning the Company’s business, operations and financial condition.
“Forward-looking statements” consist of all non-historical information, and the
analysis of historical information, including the references in this Quarterly
Report to future revenue growth, collaborative agreements, future expense
growth, future credit exposure, earnings before interest, taxes, depreciation
and amortization, future profitability, anticipated cash resources, anticipated
capital expenditures, capital requirements, and the Company’s plans for future
periods. In addition, the words “could”, “expects”, “anticipates”, “objective”,
“plan”, “may affect”, “may depend”, “believes”, “estimates”, “projects” and
similar words and phrases are also intended to identify such forward-looking
statements.
Actual
results could differ materially from those projected in the Company’s
forward-looking statements due to numerous known and unknown risks and
uncertainties, including, among other things, unanticipated technological
difficulties, the length and scope of our clinical trials, costs related
to
intellectual property related expense, cost of manufacturing and higher
consulting costs, product demand, changes in domestic and foreign economic,
market and regulatory conditions, the inherent uncertainty of financial
estimates and projections, the uncertainties involved in certain legal
proceedings, instabilities arising from terrorist actions and responses thereto,
and other considerations described as “Risk Factors” in other filings by the
Company with the SEC. Such factors may also cause substantial volatility
in the
market price of the Company’s Common Stock. All such forward-looking statements
are current only as of the date on which such statements were made. The Company
does not undertake any obligation to publicly update any forward-looking
statement to reflect events or circumstances after the date on which any
such
statement is made or to reflect the occurrence of unanticipated
events.
Plan
of Operations
We
were
originally incorporated in the state of Colorado on June 5, 1987 under the
name
Great Expectations, Inc. We were administratively dissolved January 1, 1997
and
reinstated June 18, 1998 under the name Great Expectations and Associates,
Inc.
In 1999, we became a reporting company under the Securities Exchange Act
of
1934, as amended. We were a publicly traded “shell” company without any business
until November 12, 2004 when we acquired Advaxis through the issuance of
15,597,723 shares
of
our Common Stock (the “Share Exchange”), as a result of which Advaxis become our
wholly-owned subsidiary and our sole operating company. For financial reporting
purposes, we have treated the Share Exchange as a recapitalization, where
Advaxis was the acquirer. As a result of the foregoing as well as the fact
that
the Share Exchange is treated as a recapitalization of Advaxis rather than
as a
business combination, the historical financial statements of Advaxis on November
12, 2004 became our historical financial statements after the Share
Exchange.
We
are a
biotechnology company which utilizes multiple mechanisms of immunity with
the
intent to develop cancer vaccines that are more effective and safer than
existing vaccines. We believe that by using our licensed Listeria System
to
engineer a live attenuated Listeria monocytogenes bacteria to secrete a protein
sequence containing a tumor-specific antigen, we will force the body’s immune
system to process and recognize the antigen as if it were foreign, creating
the
immune response needed to attack the cancer.
We
have
no customers. We are in the development stage and focus our initial development
efforts on six lead compounds and anticipate commencing a Phase I clinical
study
of Lovaxin C, a potential cervical and neck cancer vaccine, in the third
quarter
of 2005.
Our
revenues, which primarily comprise of grants received from the National
Institute of Health (“NIH”) amounted to $440,851
for the nine months ended July 31, 2005.
Research
and development expenses, which principally
comprise manufacturing of our cancer vaccine, laboratory supplies, wages,
consulting and toxicology studies and are recognized
expenses as incurred, amounted to $965,783 for the nine months ended July
31,
2005. We recognize research and development expenses as incurred. During
the
year ending October 31, 2005 and beyond, we anticipate that our research
and
development expenses will increase as a result of our expanded development
and
commercialization efforts related to toxicology studies, clinical trials,
product development, and development of strategic and other relationships
that
will be required ultimately for the licensing, manufacture and distribution
of
our product candidates.
We
sold
for aggregate gross proceeds of approximately $4,353,000 in a private placement
effected in four tranches on November 12, 2004, December 8, 2004, January
4,
2005 and January 10, 2005 an aggregate of 15,167,248 shares of our common
stock
and five year
warrants to purchase an aggregate of 15,167,248 shares of our common stock
exercisable at a price of $.40 per
share. The sales were exempt from registration under the Securities Act of
1933
pursuant to Registration D under the Act. In addition we issued to the Placement
Agent and its designees 2,283,445 shares of Common Stock and five year warrants
to purchase an aggregate of 2,283,445 shares of Common Stock.
At
July
31, 2005, our cash was $2,517,256, and our working capital was
$1,925,366.
We
intend
to use the proceeds of the private placement during the next 12 months to
conduct a Phase I clinical trial in cervical cancer using Lovaxin C, one
of our
lead product candidates in development using our Listeria System, expand
our
research and development team, further the development of the product candidates
and expand our manufacturing capabilities and strategic activities.
During
the next 12 to 24 months, we anticipate that our strategic focus will be
to
achieve several objectives. Our foremost objectives are as follows:
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·
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Initiate
and complete phase I clinical study of Lovaxin C;
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·
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Continue
pre-clinical development of our
products;
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·
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Continue
research to expand our technology
platform.
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We
have
purchased laboratory and office equipment totaling $75,586 and expect to
purchase some additional equipment. We hired two fulltime employees and expect
to hire 1-3 additional employees, primarily in the research and development
areas.
Our
longer-term funds requirements including the commercialization of our existing
or future product candidates will require us to seek additional capital through
(i) the sale of our equity or debt securities, (ii) financial arrangements
with
corporate and other partners, and (iii) increased license fees and milestone
payments and research collaboration fees in the event we enter into research
collaborations arrangements with third parties. Depending upon market
conditions, we may not be successful in raising sufficient additional capital
for our long-term requirements. In such event, our business, prospects,
financial condition and results of operations could be materially adversely
affected.
Off-balance
sheet arrangements.
We
are
party to a license agreement, dated June 17, 2002, as amended, between Advaxis
and The Trustees of the University of Pennsylvania, pursuant to which Advaxis
has agreed to pay $482,000 in licensing fees in annual payments on December
15,
2005, 2006 and 2007, respectively or upon certain financing milestones, and
in
addition $525,000 over a four-year period as a royalty after the first
commercial sale of our products covered by the license. Advaxis is also
obligated to pay annual license maintenance fees under this agreement ranging
from $25,000 to $125,000 per year after the first commercial sale of a product
under the license.
Item
3. Controls and Procedures.
As
of the
end of the period covered by this report, based on an evaluation of the
Company’s disclosure controls and procedures (as defined in Rules 13a-15(e)
under the Securities Exchange Act of 1934), the Chief Executive Officer and
Chief Financial Officers of the Company have concluded that the Company’s
disclosure controls and procedures are effective to ensure that information
required to be disclosed by the Company in its Exchange Act reports is recorded,
processed, summarized and reported within the applicable time periods specified
by the SEC’s rules and forms.
There
were no significant changes in the Company’s internal controls or in any other
factors that could significantly affect those controls subsequent to the
date of
the most recent evaluation of the Company’s internal controls by the Company,
including any corrective actions with regard to any significant deficiencies
or
material weaknesses.
Part
II - OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
We
effected a private placement to accredited investors at a price of $25,000
per
Unit of an aggregate of 15,167,248 shares of our Common Stock and five year
warrants to purchase an aggregate of 15,167,248 shares of Common Stock at
an
exercise price of $.40 per share. Each Unit was comprised of 87,108 shares
and
87,108 warrants. The placement occurred in four tranches. The first which
occurred on November 12, 2004 involved the sale of 117 Units including 5.12
Units paid by the cancellation of our promissory notes in the amount of $595,000
including accrued interest. The second tranche, effected on December 8, 2004
was
for 8 Units. The third tranche, effected on January 4, 2005, was for 5 Units.
The fourth tranche, effected on January 10, 2005, was for 44 units. The
Placement Agent, Sunrise Securities, Inc., received from the Company a cash
commission of $50,530 and it and its designees received 2,283,445 shares
of
Common Stock and five year warrants to purchase 2,266,900 shares of common
stock.
The
net
proceeds of approximately $4,023,327, net of expenses of $329,673, will be
used
for working capital.
The
offer
and sale were exempt from registration and the Securities Act of 1933, as
amended by virtue of the provisions of Section 4(2) and Regulation D
thereunder.
Between
February 1, 2005 and July 31, 2005 we issued 400,635 common shares in exchange
for services. In addition, we issued 156,794 common shares to our Chief
Executive Officer as a bonus for year 2004.
We
are
obligated to issue, but have not yet issued, 14,000 shares to a consultant
for
services rendered in the period.
Item
6. Exhibits
(a) Exhibits:
31.1 |
Certification
of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002.
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31.2 |
Certification
of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley
Act of 2002.
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32.1 |
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
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32.2 |
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
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SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused
this
report to be signed on its behalf by the undersigned, hereunto duly
authorized.
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Advaxis,
Inc. |
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By: |
/s/ J.
Todd Derbin |
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J.
Todd Derbin
President,
Chief
Executive Officer
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By: |
/s/ Roni
Appel |
|
Roni
Appel Chief Financial Officer |
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