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UNITED STATES
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SECURITIES AND EXCHANGE COMMISSION
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Washington, D.C. 20549
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FORM S-1
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REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
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AVAX
Technologies, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware
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2836
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13-3575874
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(State or jurisdiction of
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(Primary Standard Industrial
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(I.R.S. Employer Identification No.)
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incorporation or organization)
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Classification Code Number)
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2000
Hamilton Street
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Suite
204
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Philadelphia,
Pennsylvania 19130
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(215)
241-9760
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www.avax-tech.com
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(Address, including zip code, and telephone number,
including area code, of registrants principal executive offices)
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Copy to:
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FRANCOIS
R. MARTELET, M.D.
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RICHARD
M. WRIGHT, JR.
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President
and Chief Executive Officer
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Gilmore
& Bell, P.C.
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2000
Hamilton Street
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2405
Grand Boulevard
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Suite
204
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Suite
1100
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Philadelphia,
Pennsylvania 19130
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Kansas
City, Missouri 64108
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(215)
241-9760
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(816)
221-1000
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(Name, address and telephone number of agent for service)
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Approximate date of proposed sale to the public: From time to time after the effective date of this registration statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box:
x
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Ruler 12b-2 of the Exchange Act. (Check one):
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Large Accelerated Filer
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Accelerated Filer
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Non-accelerated Filer
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Smaller Reporting Company
CALCULATION OF REGISTRATION FEE
Title of each class of
securities to be
registered
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Amount to be
Registered
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Proposed maximum
offering price
per Unit
(1)
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Proposed maximum
aggregate offering price
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Amount of
registration fee
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Common Stock
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250,000,000
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$0.11
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$27,500,000
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$1,081
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(1)
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Estimated for the purposes of calculating the registration fee pursuant to Rule 457(c) under the Securities Act of 1933, and based on the average of the high and low prices of our common stock reported by the OTC Bulletin Board on February 1, 2008.
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The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
Table of Contents
SUBJECT TO COMPLETION, DATED FEBRUARY __,
2008
THE
INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY NOT
SELL THESE SECURITIES UNTIL THIS REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN
OFFER TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
PROSPECTUS
AVAX Technologies, Inc.
250,000,000
Shares
Common
Stock
Our
common stock is traded on the OTC Bulletin Board under the symbol AVXT.OB. On
February 1, 2008, the last reported sale price of our common stock was $0.11.
Investing in our common stock involves a high degree
of risk. You should consider carefully the risk factors beginning on page 4.
Neither the Securities and Exchange Commission nor any
state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any representation to
the contrary is a criminal offense.
The date of this prospectus is _______________ __, 2008
2
TABLE OF CONTENTS
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Page
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PROSPECTUS SUMMARY
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1
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RISK FACTORS
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4
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We will continue to need to raise
additional capital in the future to implement fully our plan of operation;
limited cash resources have slowed our plan of operation in the past and may
do so in the future
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4
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We now conduct all AC Vaccine manufacturing
out of our Lyon, France facility, which creates business uncertainties and
logistical risks for the treatment of patients in our clinical trials
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4
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We may not be successful in revalidating
our Philadelphia facility, and may be unable to produce vaccines at that
facility in the future
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5
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We will be required to produce the vaccine
for commercial purposes from the same facility at which vaccines were
produced for clinical trial purposes, which may limit our manufacturing
options after regulatory approval is received
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5
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The U.S. clinical trial and regulatory
approval process for our products has been and will continue to be expensive
and time consuming and the outcome uncertain
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5
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The European regulatory approval process
for our products has been and will continue to be expensive and time
consuming and the outcome uncertain
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5
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We utilize two products in our AC Vaccines
or clinical trials that are produced by third parties, and the unavailability
of those products could adversely affect our regulatory approval process in
the U.S. or Europe
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6
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We compete with other clinical programs and
other treatments for patients for our clinical trials, which will affect our
ability to enroll quickly our clinical trials
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6
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We raise capital in U.S. dollars, but have
significant expenses in France, which exposes us to currency exchange rate
fluctuation risk
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6
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We are operating in a regulated industry
where the guidance for acceptable manufacturing and testing of our products
and processes is evolving, which creates uncertainties, delays and expense
for us
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6
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We are a development stage
biopharmaceutical company, and we may never develop or successfully market
any products
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7
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Even if our AC Vaccine technology receives
regulatory approval and is determined to be safe and effective, our products
may not gain commercial acceptance
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7
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If governmental and insurance reimbursement
is not available or is insufficient, a market for our products may never
develop or be economically feasible
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7
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We may lose control over the
development, marketing and distribution of our vaccines if we enter into third party arrangements to perform or assist us in
performing any of those functions
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8
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Current and future legislation may make our
products unprofitable
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8
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We may not be able to control the pricing
of our products overseas
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8
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We may not be able to obtain or defend our
patents or operate without infringing upon the rights of others
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8
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We are heavily dependent upon the personal
reputation and personal contacts of our Chief Medical Officer, and the loss
of his services could materially adversely affect our plan of operation
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8
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No dealer, salesperson or other person has been
authorized to give any information or to make any representations other than those contained in this prospectus and, if given or
made, the information and representations must not be relied upon as having been authorized by us or the selling stockholders.
This prospectus does not constitute an offer to sell or a solicitation of an offer to buy the shares by anyone in any jurisdiction
in which the offer or solicitation is not authorized, or in which the person making the offer or solicitation is not qualified to
do so, or to any person to whom it is unlawful to make the offer or solicitation. Neither the delivery of this prospectus nor any
sale made using this prospectus will create any implication that the information contained in this prospectus is correct as of any
time after its date.
-ii-
Table of Contents
P
ROSPECTUS SUMMARY
This summary does not contain all of the
information that you should consider before investing. We encourage you to read this entire prospectus, including the Risk Factors
section and the financial statements and related notes, before deciding to invest in our common stock.
Our Business
We are a
development stage biotechnology company specializing in the development and future commercialization of individualized vaccine
therapies and other technologies for the treatment of cancer. Our vaccine consists of autologous (the patients own) cancer
cells that have been treated with a chemical (haptenized) to make them more visible to the patients immune
system. We refer to our cancer vaccine technology as autologous cell vaccine immunotherapy and to the vaccine as the AC Vaccine.
Our previous clinical trials for the AC Vaccine have concentrated on melanoma, ovarian carcinoma, which are our primary
indications, and non-small cell lung cancer. We refer to our AC Vaccine candidates as:
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M-Vax for
the treatment of melanoma. The current clinical status of our M-Vax program
is as follows:
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Phase I-II
Multiple dose safety and efficacy study launched in June 2005 and completed
in December 2007.
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Phase III
Registration study enrollment commenced in November 2007. The study is the
subject of a Special Protocol Assessment granted by the U.S. Food and Drug
Administration (FDA).
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L-Vax for
the treatment of non-small cell lung cancer. The current clinical status of our
L-Vax program is as follows:
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Phase I-II
Multiple dose safety and efficacy study launched in December 2005.
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O-Vax for
the treatment of ovarian cancer. The current clinical status of our O-Vax
program is as follows:
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Phase I-II
Multiple dose safety and efficacy study anticipated to launch in 2008,
subject to obtaining sufficient financing to implement fully our plan of
operation described in this prospectus.
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We
have and intend to continue to concentrate our development efforts in pursuing
regulatory approvals in melanoma and ovarian indications, which we believe
represent more attractive long-term commercial opportunities than the non-small
lung cancer indication. To maximize those opportunities for all three
indications, however, we anticipate that we may seek alliances or strategic
partnerships for one or more indications with large pharmaceutical companies to
maximize our regulatory, clinical and commercialization efforts.
We
also offer biological manufacturing services to other biotechnology and
pharmaceutical companies. These services are provided utilizing the same
facilities and personnel that produce our products for clinical and commercial
purposes.
In
Europe, and more recently in South America, we have made M-Vax available for
patient treatment on a compassionate use basis. Compassionate use is considered
for patients who have failed to respond to accepted standards of care for their
cancer and are facing a prognosis of imminent death. Although it is not the
primary purpose of compassionate use of our vaccine, we receive payments for
the vaccine from the hospitals that contract for the acquisition of the
vaccine.
In
1995, we identified the AC Vaccine research being conducted by Dr. David Berd,
an oncologist and professor at Thomas Jefferson University in Philadelphia, and
licensed the rights to Dr. Berds research. Since then, we have focused our
efforts on the development of an immunotherapy for the treatment of cancer, the
AC Vaccine technology. On November 1, 2004, Dr. Berd joined our company as our
Chief Medical Officer.
We
are primarily focusing our efforts on the development of immunotherapies for
the treatment of cancer. Historically, chemotherapies have been the only
accepted post-surgical treatment for cancer. Chemotherapy is the prevention or
treatment of disease by administering chemicals or drugs. Alternatively,
immunotherapy is the treatment of disease or infection by stimulating the
bodys immune system through a process of immunization. When a person is
immunized for a particular disease or infection, that person is injected with
portions of or all of the disease agent itself, which stimulates the bodys
immune system to fight the foreign agent. In this way, he or she builds up
immunity to the disease or infection. Immunotherapies that are being developed
to treat cancer are intended to act in the same way. Through our agreement with
Thomas Jefferson University and Dr. David Berd, we are researching and
attempting to develop a safe, effective immunotherapy for the treatment of
cancer.
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Our
leading product candidate is an autologous cell vaccine (AC Vaccine) referred
to as M-Vax, which is designed as an immunotherapy for the post-surgical
treatment of cancer. Initially we are targeting our developmental efforts on
late stage (stages 3 and 4) melanoma. Autologous cell vaccine means a vaccine
produced from the patients own cancer cells. Melanoma is a highly malignant
tumor that can spread so rapidly that it can be fatal within months of
diagnosis. We believe that M-Vax is the first immunotherapy to suggest, from
clinical trial results, that its use may result in a significant improvement in
the survival rate for patients with stage 3 melanoma.
In
2002, we filed two Investigational New Drug (IND) applications with the U.S.
Food and Drug Administration for the treatment of patients with melanoma and
ovarian cancer. We do not have any drug products that have been approved by the
FDA and are not currently engaged in clinical testing of any products in the
U.S. We cannot currently anticipate when, if ever, we will have drug products
in the U.S. market.
In
France, we prepared and filed a Biological License Application (BLA) filing
with AFSSAPS (the French counterpart of the FDA) for the treatment of stage 3
melanoma patients in 2004. In November 2003, we held a pre-BLA meeting with
AFSSAPS representatives to discuss revisions to the manufacturing of the AC
Vaccine, the planned testing of the final product and our desire to file our
BLA utilizing the data generated to date.
In
December 2003/January 2004, we filed two INDs in France for use of the AC
Vaccine for hepatic and peritoneal cancer, which will also include patients
that have ovarian and colorectal cancers that have metastasized to these
locations. We believe that the AC Vaccine is a technology that has application
in a broad spectrum of solid tumor cancers. By initiating and completing trials
for other cancer indications, we are seeking to demonstrate this.
The
regulatory approval process for new drugs in France is substantially similar to
the process in the U.S. While there is no expressly specified approval process
in the U.S. for cell and gene therapies, in 2002 AFSSAPS published regulations
specific to the approval of new cell and gene therapies (which includes the AC
Vaccine technology). Our BLA filing in France for M-Vax was one of the first
autologous products to be covered by these new regulations. Our experience
since these filings has demonstrated that the AFSSAPS regulations, while more
specific than any written guidance from the FDA in the U.S., does not
necessarily create a more certain or clearly defined regulatory path for our AC
Vaccine products. Accordingly, the regulatory approval path for our products in
France, as in the U.S. and the rest of Europe, is likely to continue to evolve
over time.
Since
2003, we have made M-Vax available for sale on a compassionate use basis in
various European countries. Compassionate use is considered for patients who
have failed to respond to accepted standards of care for their cancer and are
facing a prognosis of death. Regulatory authorities in France, Spain, Belgium,
Greece and Venezuela have allowed us to make M-Vax available to patients
through compassionate use (even though there is no approval for marketing of
M-Vax in those countries) when the patients prognosis is death and there are
no alternative treatments available to the patient. Through December 31, 2007,
we had 128 patients present for treatment on a compassionate use basis, of
which 60 patients were treated and 16 vaccines have been produced and tested
and are awaiting release to the clinical site. The patients who were not
treated were untreatable with the vaccine as a result of inadequate cell count
in the tumor sample received, the tumor samples received were not melanoma,
sterility issues with the tumor sample, or the death of the patient prior to
treatment being available. We expect to continue to treat patients on a
compassionate use basis outside the U.S. This development is important to us
and our AC Vaccine technology because it expands the availability of the AC
Vaccine within the scientific and medical communities that are now seeking out
the compassionate use of M-Vax. These experiences of oncology leaders in
various countries may become critical to the overall scientific acceptance of
the AC Vaccine technology in these countries. This also will allow us to
educate practitioners to maintain and aseptically handle and ship tumors to
reduce incidences where tumors become contaminated. Additionally, although it
is not the primary purpose of compassionate use of our vaccine, we receive
payments for the vaccine from the hospitals that contract for the acquisition
of the vaccine.
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Based
upon re-engineering the manufacture of the vaccine technology, we no longer
require regional manufacturing capabilities for clinical trial purposes. We
made a strategic decision in early 2003 to use our facility in Lyon, France as
our primary facility for the production of our cell based therapies. Our Lyon
facility has been inspected by AFSSAPs (the French equivalent of the U.S. FDA)
and received the designation of Etablissement Pharmaceutique in 2002 and
obtained the designation Etablissement Thérapies Gèniques et Cellulaires in
2004. The Etablissement Pharmaceutique designation is required for the
production of any commercial product to be sold in France and throughout
Europe. The Etablissement Therapies Geniques et Cellulaires designation is
required in France for the commercial production of cell and gene therapy
products.
In
the U.S., we had previously initiated clinical trials to evaluate the safety
and efficacy of M-Vax and O-Vax (our AC Vaccine for ovarian cancer). In March
and April 2001, we received first oral notification and then written
confirmation from the FDA that clinical activities then underway for both our
M-Vax and O-Vax autologous cancer vaccines were placed on clinical hold pending
further review by the agency. The written notification from the FDA confirming
the clinical hold identified the specific issues that the FDA wanted addressed,
which dealt primarily with the sterility of autologous tumors received by us at
the Philadelphia facility and the assurance that vaccines being provided to
patients would meet FDA sterility guidelines. In conjunction with the clinical
hold, the FDA conducted an inspection of our manufacturing facility in
Philadelphia. The issues identified by the FDA in this inspection focused
primarily on the sterility of autologous tumors received by us at the
Philadelphia facility, the handling of sterile and non-sterile tumors and
assurance that vaccines being provided to patients would meet FDA sterility
guidelines.
In
working with the FDA to resolve the issues identified as part of the clinical
hold, we concluded that (1) it would no longer be feasible to continue the
clinical development of the original AC Vaccine format without the ability to
ensure clinical samples have completed sterility testing prior to
administration (referred to as the fresh vaccine product format), and (2) a
revised product format needed to be established, tested and reviewed by the FDA
which allowed us to test the vaccine for sterility prior to administration of
the vaccine to patients. Through these research and development activities we
re-engineered the manufacturing steps for the production and distribution of
the AC Vaccine, referred to as the frozen vaccine technology. Based upon the
changes to the manufacturing of the product, the FDA recommended that we
consider preparing and filing new INDs for the frozen vaccine. At the
recommendation of the FDA, we inactivated the INDs for M-Vax and O-Vax, and filed
new INDs for the revised product format for the AC Vaccine for melanoma and
ovarian cancer, which IND filings were accepted by the FDA. Our Philadelphia
facility was cleared at that time to begin processing clinical samples for
administration to patients in clinical trials. We have commenced our clinical
trial for melanoma in the U.S. for the treatment of melanoma with the AC
Vaccine, using DTH as the endpoint.
Company Information
We
were incorporated in the State of New York on January 12, 1990. On October 22,
1992, we merged into Walden Laboratories, Inc. (Walden), a Delaware
corporation, which was incorporated on September 18, 1992. We changed our name
from Walden Laboratories, Inc., to AVAX Technologies, Inc., effective
March 26, 1996.
Our
principal executive office is located at 2000 Hamilton Street, Suite 204,
Philadelphia, Pennsylvania 19130. The telephone number at that address is (215)
241-9760.
The Offering
We
may sell securities pursuant to this prospectus in or outside the U.S. (a)
through underwriters or dealers, (b) through agents or (c) in private sales
directly to one or more purchasers, as more fully described under Plan of
Distribution. We will describe our plan of distribution more fully in a
prospectus supplement to this prospectus when we have determined the most
appropriate manner for us to sell securities pursuant to this prospectus.
3
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R
ISK FACTORS
Investing
in our securities involves a high degree of risk. Before making a decision
about investing in our securities, one should carefully consider the risk
factors listed below, as well as the rest of the information contained in this
prospectus.
W
e will continue to need to
raise additional capital in the future to implement fully our plan of operation;
limited cash resources have slowed our plan of operation in the past and may do
so in the future.
We
presently anticipate that our current cash resources will be sufficient to fund
operations through May 2008, assuming that we significantly slow our current
development plans until we raise additional capital. We are targeting to raise
between $10.0 million and $25.0 million in this offering. If we are able to
raise only $10.0 million, we will have cash resources to implement the
development plan for M-Vax, as discussed under Plan of Operation to the
second quarter of 2009, but would not have sufficient resources to commence the
Phase I-II trial for O-Vax or to continue the current Phase I-II trial for
L-Vax. Even if we are able to raise the full $25.0 million, those funds and our
existing cash resources will only allow us to implement our plan of operation
through the second half of 2010. In addition, we have only a limited ability to
generate revenues from operations, and any revenues we generate are almost
certain to be substantially less than our operating expenses. Accordingly,
whether we raise only $10.0 million or $25.0 million in this offering, it will
be necessary to raise additional equity capital in 2009 or 2010 to implement
fully our plan of operation. Because of our limited cash and financial
resources, unless we are successful in raising additional capital in this
offering, our ability to continue as a going concern beyond the second quarter
of 2008 is in question.
In
the past, we have had periods in which we have been unable to raise adequate
capital, and as a result, we have ceased certain of our product development
programs and have taken numerous other steps to reduce our cash expenditures.
Each of these steps, while conserving cash, has slowed the prospects of success
in various product development efforts.
We
have no way of knowing if we will be able to complete this offering at the
maximum level sought or to complete any additional future financings.
W
e now conduct all AC
Vaccine manufacturing out of our Lyon, France facility, which creates business
uncertainties and logistical risks for the treatment of patients in our
clinical trials.
We
previously manufactured our AC Vaccine for U.S. patients enrolled in our
clinical trials at our facility in Philadelphia. We now conduct all AC Vaccine
manufacturing at our Lyon, France facility. In our current clinical trials in
the U.S. for M-Vax and L-Vax, we encounter various business uncertainties and logistical
risks associated with the transport of biologics (consisting of human tumor
cells) to France and shipping a patients individualized AC Vaccine back to the
U.S. Had we been using this business model in September 2001, the September 11
attacks in the U.S. and the resultant suspensions and interruptions of
international travel and shipments would have significantly disrupted our
treatment of patients. There are additional risks associated with the transport
of biologics and vaccines, including the time constraints under which a tumor
must be received and processed and the specialized shipping requirements of the
vaccine after it is manufactured. Although we have developed plans to manage
these risks, we may encounter disruptions that we are unable to control, which
could adversely affect the willingness of U.S. patients to enroll in our
clinical studies or otherwise disrupt our clinical development of the AC
Vaccine.
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W
e
may not be successful in revalidating our Philadelphia facility, and may be unable
to produce vaccines at that facility in the future.
We are in
the process of revalidating our Philadelphia facility for the purpose or
re-establishing that facility as a current Good Manufacturing Practices
facility in which our vaccines and other biologics can be produced. We may not
be successful in those efforts, or those efforts may take longer or cost more
than we currently anticipate. Our failure to revalidate the Philadelphia
facility will heighten our continued reliance upon our Lyon, France facility
for the production of all vaccines, and the logistical risks associated with
manufacturing the vaccine in Europe while many of our clinical trials sights
are in the U.S. Our current objective is to have approximately half of the
patients in the Phase III registration trail for M-Vax be from the U.S., with
the vaccine produced in the U.S., and approximately half of the patients from
Europe, with the vaccine produced at the Lyon facility.
W
e
will be required to produce the vaccine for commercial purposes from the same
facility at which vaccines were produced for clinical trial purposes, which may
limit our manufacturing options after regulatory approval is received.
Under
current FDA regulations, if we obtain FDA regulatory approval for the
commercialization or one or more of our vaccines, we will be required initially
to produce the vaccine for commercial purposes at the same facility or
facilities at which we produced the vaccine during the Phase III registration
trail for that indication. Accordingly, we may have limited flexibility to
change our manufacturing facilities after commercialization of a vaccine has
been approved by the FDA until a new facility can be validated and pass all
required FDA regulatory approvals for the production of the vaccine. The FDA
may even require a new or expanded clinical trial of the vaccine produced at a
new manufacturing facility before the vaccine may be produced for commercial
purposes at that facility. Those additional regulatory approvals could be time
consuming and expensive and could delay commercialization of the approved
vaccine product.
T
he U.S. clinical trial and
regulatory approval process for our products has been and will continue to be
expensive and time consuming and the outcome uncertain.
To
obtain regulatory approval for the commercial sale of our products in the U.S.,
we must demonstrate through clinical trials that our products are safe and
effective. We will continue to incur substantial expense for, and devote a
significant amount of time to, pre-clinical testing and clinical trials of our
products in the U.S. The results from pre-clinical testing and early clinical
trials are not totally predictive of results that may be obtained in later
clinical trials. Data obtained from pre-clinical testing and clinical trials
are susceptible to varying interpretations, which may delay, limit or prevent
regulatory approval. In addition, regulatory delays or rejections may be
encountered as a result of many factors, including changes in regulatory policy
during the period of product development. Our business and financial condition
will be materially and adversely affected by any delays in, or termination of,
our clinical trials.
Our
clinical trials for the AC Vaccine were placed on clinical hold by the FDA in
spring 2001. We did not re-file the INDs until fall 2002 to recommence clinical
trials. That delay was costly to us in terms of both time and money. During
that 16-month period, we were unable to proceed with any patients in our AC
Vaccine clinical trials. Similar delays could occur in the future, resulting in
significant delays, expense and lost opportunities. Even though the new INDs
have been initiated, we still may not be able to obtain the funding to complete
the U.S. regulatory approval process or we may fail to obtain FDA approval for
our products. We may never be able to commercialize our AC Vaccine products in
the U.S.
T
he European regulatory
approval process for our products has been and will continue to be expensive
and time consuming and the outcome uncertain.
To
offering any of our vaccine products for commercial sale in European Union
countries we must either obtain the regulatory approval from the European
Medicines Evaluation Agency (EMEA), which approval will be binding upon all
European Union countries, or from the applicable regulatory body in each
European or other country in which we desire to offer the product for
commercial sale. We have encountered regulatory delays in Europe in the past and
may well experience further delays in our desired regulatory approval path in
the future.
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For
example, in March 2005, we submitted a Biological License Application filing
with AFSSAPs (the French counterpart of the U.S. FDA) for the treatment of
stage 3 and 4 melanoma patients in France. In February 2006, AFSSAPs notified
us that the filing was not approvable with the current data and that additional
data would be necessary to support an approval. Our business and financial
condition may be materially and adversely affected by future delays in the
regulatory approval process in Europe, and we may never be able to
commercialize our AC Vaccine products in Europe.
W
e utilize two products in
our AC Vaccines or clinical trials that are produced by third parties, and the
unavailability of those products could adversely affect our regulatory approval
process in the U.S. or Europe.
We
administer the AC Vaccine with Bacillus Calmette-Guerin (BCG), which is an
approved product for other cancer indications and is being administered by
other companies as a separate vaccine. There are several sources of BCG, each
formulation of which differs based upon the original source of the product. If
we are unable to continue to obtain the current strain of BCG used in our
clinical trials, we may not be permitted by regulatory authorities to use
another strain of BCG without conducting additional clinical studies with the
new strain of BCG.
For
our Phase III registration trial for M-Vax, the M-Vax arm will consist of an
initial dose of M-Vax (autologous DNP-modified tumor cells) followed by
cyclophosphamide (CY) and six weekly doses of M-Vax administered with BCG.
Following vaccine administration, patients will receive a course of low dose
IL-2 administered subcutaneously. IL-2 is produced exclusively by Novartis AG,
and if we or our clinicians are unable to continue to obtain IL-2 from
Novartis, we may not be permitted by the FDA to continue our current Phase III
clinical trial for M-Vax.
W
e compete with other
clinical programs and other treatments for patients for our clinical trials,
which will affect our ability to enroll quickly our clinical trials.
We
compete with numerous clinical trials and other treatment regimens (both in the
U.S. and Europe) for patients for our clinical trials and will compete with
those programs for patients for our clinical trials. Companies with clinical
trials, including us, provide information and other incentives to oncologists
and other specialists as an inducement to participate in clinical trials. A
physician is required to place patients in clinical trials based upon the
physicians assessment of the likely benefits of that clinical trial to the
patient. The information provided by us regarding any future clinical trials
may not be sufficient to persuade physicians to place their patients in our
clinical trials. We have experienced intense competition for patients for our
previous clinical trials.
W
e raise capital in U.S.
dollars, but have significant expenses in France, which exposes us to currency
exchange rate fluctuation risk.
We
conduct our capital raising efforts in U.S. dollars, while a significant
portion of our revenues and expenses are generated and incurred in currencies
other than U.S. dollars, mainly Euros. To the extent that we are unable to
match revenues received in foreign currencies with costs paid in the same
currency, exchange rate fluctuations in any such currency could have an adverse
effect on our results of operations and cash flows.
W
e
are operating in a regulated industry where the guidance for acceptable
manufacturing and testing of our products and processes is evolving, which
creates uncertainties, delays and expense for us.
Regulatory
standards require that we produce our products in compliance with current Good
Manufacturing Practices. These requirements, as dictated by the applicable U.S.
and European regulatory authorities, adopt the methods for end product
standards and methods of analysis, which in the U.S. guidance is published in
the United States Pharmacopoeia (similar guidance for Europe is published in
the European Pharmacopoeia). In February 2002, the United States Pharmacopeia
issued a new general information chapter entitled cell and gene therapy
products, which became effective April 2002. This relates to the production
and testing of cell and gene therapy products. This is the first known industry
general guideline specifically related to the manufacture of cell and gene
therapy products. New guidance can be expected as the cell and gene therapy
areas of the pharmaceutical industry expand. We will be required to adapt our
existing physical facilities, process and procedures to these standards for the
production of our products during clinical testing and for future
commercialization. The inability to adapt to these evolving standards will
delay our ability to produce product for clinical testing and would delay our
ability to enter into clinical trials.
6
Table of Contents
W
e are a development stage
biopharmaceutical company, and we may never develop or successfully market any
products.
Investors
must evaluate us in light of the expenses, delays, uncertainties and
complications typically encountered by development stage biopharmaceutical
businesses, many of which we have already experienced and many of which are
beyond our control. The risks of a development stage biopharmaceutical company
that we have already encountered include:
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the FDA
clinical hold of our AC Vaccine clinical trials in 2001 and the resultant
substantial expenses and delays in resolving the FDA concerns and refiling
new INDs for the reformulated AC Vaccine products;
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manufacturing
challenges relating to the production of a vaccine from the patients own
cancer cells, such as the sterility issues we previously experienced at our
Philadelphia facility;
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our failure
to develop a market for the AC Vaccine in Australia, notwithstanding
substantial expenditures of time and money to do so;
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our past
inability to agree with the FDA on an acceptable potency assay (which is a
biological measure of the drugs active ingredients) of our product prior to
administration of the vaccine, which agreement was required before we could
commence a Phase III registration trial for M-Vax;
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our
inability to generate any meaningful revenues from any other products or
services while we work to develop our lead products and technologies; and
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the cutbacks
in our development plans and programs due to the limited cash resources in
recent years, and our continual need to raise additional capital.
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As
a result of these and likely continuing challenges of being a development stage
biopharmaceutical company, our products may never be successfully developed or
marketed.
E
ven if our AC Vaccine
technology receives regulatory approval and is determined to be safe and
effective, our products may not gain commercial acceptance.
Even
if the AC Vaccine technology is safe and effective, there is no guarantee of
commercial acceptance. Because the AC Vaccine technology is a new approach to
the treatment of cancer, it must be accepted by both patients and physicians
before it can be successfully commercialized. Due to the nature of the vaccine
technology it requires that current practitioners revise the way they think
about cancer and cancer treatment. The marketplace of ideas, technologies and
information is crowded, and we must develop the means to reach leading
specialist physicians in each market with the AC Vaccine story.
I
f
governmental and insurance reimbursement is not available or is insufficient, a
market for our products may never develop or be economically feasible.
The
availability of governmental and insurance reimbursements of the costs of the
vaccine is critical to ultimate physician and patient acceptance of the AC
Vaccine technology. In both the U.S. and other countries, sales of our products
will depend in part upon the availability of reimbursement from third-party
payors, which include government health administration authorities, managed
care providers, and private health insurers. For new products or technologies,
reimbursement must be established under existing governmental or insurance
regulations or practices. We will be required to obtain reimbursement approvals
(both governmental and insurance) in each country in which we obtain
appropriate regulatory authority to market the AC Vaccine products.
In
addition, third-party payors are increasingly challenging the price and
examining the cost effectiveness of medical products and services. Significant
uncertainty surrounds the reimbursement status of newly approved health care
products, and our products may not be considered cost effective by a particular
governmental authority or insurer. Adequate third-party reimbursement may not
be available to enable us to maintain price levels sufficient to realize an
appropriate return on our investment in the research and development of our
products.
7
Table of Contents
We may lose control over the development,
marketing and distribution of our vaccines if we enter into third party
arrangements to perform or assist us in performing any of those functions.
We
may seek alliances or strategic partnerships for one or more of our AC Vaccine
products with large pharmaceutical companies to maximize our regulatory,
clinical and commercialization efforts. We may also have to depend on third
parties to market and distribute our products. We currently do not have the
resources to develop fully, market or distribute M-Vax, O-Vax, L-Vax or any
other products that we may develop in the future. Moreover, it is particularly
difficult and expensive to develop and distribute the AC Vaccine products,
because they are custom made for each individual patient.
If
we enter into alliances, strategic partnerships or distribution agreements with
third parties, we may have less control over the development, marketing and
distribution activities performed by third parties than if we were performing
those functions with our own facilities and employees. This lack of direct
control could adversely affect the results of these activities.
Current and future legislation may make our
products unprofitable.
Current
and future legislation can and likely will continue to affect directly the
ultimate profitability of pharmaceutical products and technologies. The U.S.
and other countries continue to propose and pass legislation designed to reduce
the cost of healthcare. Accordingly, legislation and regulations affecting the
pricing of our products may change before the products are approved for
marketing to the public. Adoption of new legislation and regulations could
further limit reimbursement for our products. If third-party payors fail to
provide adequate coverage and reimbursement rates for our products, the market
acceptance of the products may be adversely affected. In that case, our
business and financial condition will suffer. We are not aware of any specific
legislation or regulation in the U.S. or Europe designed to limit reimbursement
for products like ours, but we believe that there is a credible risk that
political and budget considerations could change dramatically the funding
available for vaccine reimbursement.
We may not be able to control the pricing of
our products overseas.
Foreign
government regulations and programs will likewise affect foreign pricing
opportunities for our products. Virtually all foreign countries regulate or set
the prices of pharmaceutical products, which is a separate determination from
whether a particular product will be subject to reimbursement under that
governments health plans. There are systems for reimbursement and pricing
approval in each country and moving a product through those systems is time
consuming and expensive.
We may not be able to obtain or defend our
patents or operate without infringing upon the rights of others.
We,
as well as our current and potential future licensors, may be unable or have
difficulty obtaining and defending our patents and maintaining our trade
secrets. If so, we could be delayed or prevented from manufacturing, using or
selling our products. It is also possible that one of our products or
technologies may infringe upon an existing U.S. or foreign patent of a third
party, or that other patents could issue in the future that could interfere
with our ability to make or sell our products. If we are involved in a patent
dispute, we may have to pay significant legal costs, license fees or damages,
and may have to stop producing and selling our products and technologies. It is
also possible that if we require the use of other patents in order to be able
to commercialize our products, we may not be able to obtain licenses for those
patents.
We are heavily dependent upon the personal
reputation and personal contacts of our Chief Medical Officer, and the loss of
his services could materially adversely affect our plan of operation.
The
inventor of the AC Vaccine technology is Dr. David Berd, who has served as our
Chief Medical Officer since November 1, 2004. Prior to then, we obtained his
services in directly through our research and license agreements with Thomas
Jefferson University, where Dr. Berd was a professor in the Medical School. The
acceptance of the AC Vaccine technology within the oncology world is highly
dependent upon the personal reputation and the personal contacts of Dr. Berd.
Dr. Berd is also critical in guiding the technology through the regulatory
process in both the U.S. and Europe. If we lost his services, the development
of our AC Vaccine technology could be significantly slower and less successful
that it otherwise would be with his services.
8
Table of Contents
We have recently appointed a new Chief
Executive Officer, and the transition to a new Chief Executive Officer could
disrupt our plan of operation.
Effective
December 1, 2007, we appointed Francois R. Martelet, M.D. as our new President
and Chief Executive Officer, and Richard P. Rainey, our then current President,
Chief Executive Officer and Chief Financial Officer, agreed to remain with the
company as our Principal Accounting Officer until May 31, 2008. We do not
anticipate that Mr. Rainey will continue in his current position with the
company beyond May 31, 2008. The change to a new Chief Executive Officer and
the future loss of our current Principal Accounting Officer could result in
delays to or future changes in the implementation of the plan of operation,
which delays or changes could adversely affect our current plan of operation.
We have always been dependent upon our small management team to obtain funding
for the research and development of our products, to decide which of our
products to promote, to shepherd the products through the clinical trial and
regulatory approval process, and to stimulate business development and seek out
new products and technologies for development. In addition, our current
financial condition makes it more difficult for us to retain our current
executives and key employees.
We may not be able to compete with other
companies, research institutes, hospitals or universities that are developing
and producing cancer treatment products and technologies.
Many
other companies, research institutes, hospitals and universities are working to
develop products and technologies in our specific field of cancer research.
Many of these entities have more experience than we do in developing and
producing cancer treatment products. Most of these entities also have much
greater financial, technical, manufacturing, marketing, distribution and other
resources than we possesses. We believe that numerous pharmaceutical companies
are engaged in research and development efforts for products that could
directly compete with our products under development. In addition, some of our
competitors have already begun testing products and technologies similar to our
own. These other entities may succeed in developing products before us or that
are better than those that we are developing. We expect competition in our
specific area of research to intensify.
The trading volume of our common stock is
relatively low and a more active market may never develop.
The
average daily trading volume in our common stock varies significantly, but is
usually low. On many days, the common stock trades less than 15,000 shares.
This low average volume and low average number of transactions per day may
affect the ability of our stockholders to sell their shares in the public
market at prevailing prices. A more active trading market for our common stock
may never develop.
Our common stock was delisted from Nasdaq in
2003, which will continue to have an adverse impact on the liquidity and
pricing of our common stock.
Our
common stock was moved from the Nasdaq National Market to the Nasdaq SmallCap
Market in 2002 and was delisted from the Nasdaq SmallCap Market in 2003 due to
the continuing failure of our stock to meet the continuing listing requirements
of both the Nasdaq National and SmallCap Markets (currently the Nasdaq Global
and Nasdaq Capital Markets, respectively). We believe that the delisting has
hurt the liquidity and pricing of our common stock, which trades on the OTC
Bulletin Board. The trading efficiencies for our common stock associated with a
listing on Nasdaq or a national security exchange will continue until our stock
is re-listed, which may never occur.
9
Table of Contents
Because our common stock is a penny stock,
you may have difficulty selling our common stock in the secondary trading
market.
The
SEC has adopted regulations that generally define a penny stock to be any
equity security that has a market price of less than $5.00 per share or with an
exercise price of less than $5.00 per share. Additionally, if the equity
security is not registered or authorized on a national securities exchange or
Nasdaq, the equity security also would constitute a penny stock. Because our
common stock falls within the definition of penny stock, these regulations
require the delivery, prior to certain transactions involving our common stock,
of a risk disclosure schedule explaining the penny stock market and the risks
associated with it. Disclosure is also required to be made in certain
circumstances regarding compensation payable to both the broker-dealer and the
registered representative and current quotations for the securities. In
addition, monthly statements are required to be sent disclosing recent price
information for the penny stocks. Accordingly, the ability of broker-dealers to
sell our common stock and the ability of stockholders to sell our common stock
in the secondary market is limited. As a result, the market liquidity for our
common stock is adversely affected by the application of these penny stock
rules. Trading in our common stock will likely continue to be adversely
affected by the application of these rules.
The rights of our preferred stockholders are
superior to the rights of our common stockholders.
The
holders of our Series C preferred stock have certain rights that are superior
to the rights of holders of our common stock, including a liquidation
preference over the common stock. In the case of (1) a liquidation, (2) if we
cease to exist by virtue of a merger in which we are not the surviving
corporation, or (3) if one person or entity acquires more than 50% of the
voting power of the company, holders of our Series C preferred stock will
receive $100 per share in cash or securities (a total of $3,350,000 as of
December 31, 2007), before any distributions are made to the holders of our
common stock. Additionally, the holders of the Series C preferred stock are
entitled to the consideration per share of common stock that they would have
received from the transaction if they had converted all of their shares of
Series C preferred stock into common stock immediately before the transaction.
These rights of the Series C preferred stock holders could result in the
holders of those shares receiving substantially more of the consideration in a
merger transaction than they would otherwise have received if they had actually
converted their shares of Series C preferred stock into common stock before the
merger transaction. The holders of our common stock would, accordingly, receive
a lesser amount in a merger transaction of that type than they would have
received if there were no outstanding shares of the Series C preferred stock.
FORWARD-LOOKING STATEMENTS
In
this prospectus, we make statements that plan for or anticipate the future.
These forward-looking statements include statements about the future of
biotechnology products and the biopharmaceutical industry, statements about our
future business plans and strategies and other statements that are not
historical in nature. These forward-looking statements are based on our current
expectations. Forward-looking statements may be identified by words or phrases
such as believe, expect, anticipate, should, planned, may,
estimated and potential. The Private Securities Litigation Reform Act of
1995 provides a safe harbor for forward-looking statements. In order to
comply with the terms of the safe harbor, and because forward-looking
statements involve future risks and uncertainties, listed below are a variety
of factors that could cause actual results and experience to differ materially
from the anticipated results or other expectations expressed in our
forward-looking statements. These factors might include those risks discussed
above under Risk Factors.
USE OF
PROCEEDS
Except
as may be stated in a prospectus supplement, we intend to use the net proceeds
we receive from any sales of securities by us under this prospectus for general
corporate purposes, including particularly the implementation of our plan of
operation discussed below under Plan of Operation.
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Table of Contents
MARKET FOR
COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our
common stock was publicly traded on the OTC Bulletin Board from December 19,
1996 through July 9, 1997. From 1997 until 2003, our common stock was
listed for quotation on the Nasdaq under the symbol AVXT, initially on the
Nasdaq Capital Market and later on the Nasdaq Global Market. The stock was
moved from the Nasdaq Global Market to the Nasdaq Capital Market in 2002 and
was delisted from Nasdaq in August 2003 due to our failure to maintain Nasdaqs
minimum continuing listing standards. Since that time, the common stock has
been traded on the OTC Bulletin Board under the symbol AVXT.OB. The following
table sets forth, for the periods indicated, the high and low sales price for
the common stock, as reported by Nasdaq, or by OTC, as applicable, for the
quarters presented. Over-the-counter market quotations reflect inter-dealer
prices, without retail mark-up, mark-down or commission and may not represent
actual transactions.
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High
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Low
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Fiscal year
ending December 31, 2005
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First quarter
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$
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0.41
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$
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0.28
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Second quarter
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0.38
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0.24
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Third quarter
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0.48
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0.18
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Fourth quarter
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0.35
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0.24
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Fiscal year
ending December 31, 2006
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First quarter
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$
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0.28
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$
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0.21
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Second quarter
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0.33
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0.13
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Third quarter
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0.20
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0.10
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Fourth quarter
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0.29
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0.10
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Fiscal year
ended December 31, 2007
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First quarter
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$
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0.33
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$
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0.09
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Second quarter
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0.46
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0.19
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Third quarter
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0.22
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0.12
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Fourth quarter
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0.17
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0.09
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Fiscal year ended December 31, 2008
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First
quarter (through February 1
st
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$
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0.11
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$
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0.09
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The
last reported sale price for our common stock on the OTC Bulletin Board on
February 1, 2008, was $0.11 per share. At February 1, 2008, there were
141,574,997 shares of common stock outstanding, which were held by
approximately 4,000 record and beneficial stockholders. The 33,500 shares of
Series C preferred stock outstanding at December 31, 2007, are convertible into
1,030,756 shares of common stock, excluding the effect of any fractional
shares.
DIVIDEND
POLICY
We
have not paid any cash dividends on our common stock since our formation. We do
not intend to declare any dividends on our common stock in the foreseeable
future. We anticipate that all earnings, if any, will be retained by us for use
in our business.
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PLAN OF OPERATION
General
Since
our inception, we have concentrated our efforts and resources on the
development and future commercialization of biotechnology and pharmaceutical
products and technologies. We have been unprofitable since our founding and
have incurred a cumulative net loss of $82,554,909 as of September 30, 2007. We
incurred net losses of $4,713,727 and $3,960,431 for the nine months ended
September 30, 2007 and 2006, respectively. We expect to continue to incur
operating losses, primarily due to the expenses associated with our product
development efforts, the cost of maintaining our manufacturing facilities in Europe
and the U.S. and activities related to the conduct of our clinical trials for
the AC Vaccine in the U.S. and Europe.
Our
ability to continue as an operating company depends upon, among other things,
our ability to raise additional capital from time to time to allow us to
develop products, obtain regulatory approval for our proposed products, and
enter into agreements for product development, manufacturing and
commercialization. Our M-Vax product does not currently generate any material
revenue, and we may never achieve significant revenues or profitable operations
from the sale of M-Vax or any other products that we may develop.
The
major challenge for us and others in the biopharmaceutical industry are the
significant costs, time and uncertainties related to efforts to obtain
regulatory approval to market drug products in the U.S. and foreign countries.
We have encountered a number of these challenges in our efforts to develop the
AC Vaccine into marketable products including the following:
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the FDA
clinical hold of our AC Vaccine clinical trials in 2001 and the resultant
substantial expenses and delays in resolving the FDA concerns and refiling
new INDs for a revised AC Vaccine;
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manufacturing
challenges relating to the production of a vaccine from the patients own
cancer cells, such as the sterility issues we previously experienced at our
Philadelphia facility;
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our failure
to develop a market for the AC Vaccine in Australia notwithstanding
substantial expenditures of time and money to do so;
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our past
inability to agree with the FDA on an acceptable potency assay (which is a
biological measure of the drugs active ingredients) of our product prior to
administration of the vaccine, which was required before we could commence
our Phase III registration trial for M-Vax;
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our
inability to generate any meaningful revenues from any other products or
services while we work to develop our lead products and technologies; and
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the periodic
cutbacks in our development plans and programs due to the limited cash
resources from time to time in recent years.
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As
a result of the FDA clinical hold, we concluded that (1) it would no longer be
feasible to continue the clinical development of the original AC Vaccine using
the established manufacturing format (referred to as the fresh vaccine
product format), and (2) a revised product format needed to be established,
tested and reviewed by the FDA. Through these research and development
activities we re-engineered the manufacturing steps for the production and
distribution of the AC Vaccine, referred to as the frozen vaccine technology,
which we believe has substantial advantages over the former fresh product.
Research and Development Expenses
Our
research and development activities focus primarily on clinical development and
trials of our AC Vaccine technology for the treatment of melanoma, ovarian
cancer, lung cancer and other cancers. Our clinical development program
includes the development of techniques, procedures and tests that need to be
developed as part of the manufacturing of our biological product so that the
product can be evaluated and potentially approved by regulatory authorities.
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Table of Contents
Our
research and development expenses consist primarily of costs associated with
the clinical trials of our product candidates, compensation and other expenses
for research personnel, payments to collaborators under contract research
agreements, costs for our consultants and compensation, materials, maintenance
and supplies for the operation and maintenance of our biological clean room
facilities, which are necessary for the production of materials to be used in
clinical trials. All of these costs qualify as research and development
expenses in accordance with the guidance included in Statement of Financial
Accounting Standards No. 2 Accounting for Research and Development Costs.
Manufacturing
costs included in this category relate to the costs of developing, supporting
and maintaining facilities and personnel that produce clinical samples in
compliance with current Good Manufacturing Practices (cGMP). Our facilities
and the personnel maintained for manufacturing are currently at what we feel
are the minimum required for compliance with cGMP. Based upon the current
capacity of our facilities, our personnel and our current and future planned
clinical trials, we have excess capacity for the production and testing of
biological products. We use this excess capacity to generate cash in the form
of contract manufacturing alliances. Because the incremental costs incurred to
provide these services are not material or quantifiable, they are not presented
separately.
Contract
manufacturing encompasses services we provide to other biotechnology or
pharmaceutical companies that are pursuing the clinical development of
biological products. The engagements generally consist of two components. The
first component is process validation in which the contracting company provides
information on its product and the processes and techniques used to produce the
product. Procedures are developed, documented and cataloged for the cGMP
production of the product using known and acceptable techniques, tests and
materials. Small scale lots are produced, and techniques, feasibility of the
production processes and tests validated. The end product of the first phase of
an engagement is a pilot batch of product and the necessary production
formulation and techniques to be used to file an IND with regulatory
authorities for human clinical trials. The second phase of an engagement
consists of the production of batches of product to be used in human clinical
trials. The typical engagement results in production of small batches of
product to be used in early stage (Phase I and II) clinical trials.
Research
and development costs incurred through September 30, 2007, were
$51,054,172. Research and development costs were $3,402,404 and $3,162,049, for
the nine months ended September 30, 2007 and 2006, respectively. The majority
of these costs relate to clinical research and development of our AC Vaccine
technology. Our management estimates that greater than 90% of the periodic and
cumulative research and development expenses incurred relate to our one major
program, the AC Vaccine. At this time, due to the risks inherent in the
clinical trial process, risks associated with the product and product
characterization and risks associated with regulatory review and approval of
clinical product candidates, we are unable to estimate with any certainty the
costs we will incur in the continued development of our product candidates for
commercialization.
Plan of Operation
Background.
In November 1995, we acquired
the rights to the AC Vaccine technology pursuant to the TJU license. Assuming
we can continue to obtain the necessary funding, we intend to continue to be
engaged in the development and commercialization of our AC Vaccine products.
We
experienced events during 2001 that significantly affected our operations. In
March and April 2001, we received first oral notification and then written
confirmation from the FDA that clinical activities for both our M-Vax and O-Vax
autologous cancer vaccines were placed on clinical hold pending further review
by the agency. The written notification from the FDA confirming the clinical
hold identified the specific issues that the FDA wanted addressed, which
primarily dealt with the sterility of autologous tumors received by us at the
Philadelphia facility and the assurance that vaccines being provided to
patients would meet FDA sterility guidelines.
In
conjunction with the clinical hold, the FDA conducted an inspection of our
manufacturing facility in Philadelphia, which inspection was completed in May
2001. As a result of that facility inspection, we received a Form 483,
which is a finding of manufacturing facility deficiencies, to which we
initially responded at the end of June 2001. The issues raised in the Form 483
were essentially consistent with those in the clinical hold letter, with no new
significant areas of concern identified.
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Table of Contents
In
developing our response to the FDA clinical hold letters and the Form 483, we
identified and began to implement a number of product development initiatives
related to the AC Vaccine technology. As a result, we determined certain
product improvements to the vaccine could be instituted that would address
certain concerns of the FDA and make the vaccine more viable from a regulatory
and commercial perspective. Throughout the remainder of 2001 and into 2002, we
continued to evaluate (1) the prospect of freezing the haptenized cells
for distribution to the end user, (2) steps that could be taken to help
ensure that final released vaccines prepared by us are sterile and (3) tests
to determine the minimal number of cells necessary for the vaccine to be
effective. Based upon the results of these efforts, we re-engineered the
manufacturing steps to create and release the vaccine technology to take
advantage of these potential product improvements.
Based
upon the changes to the product, the FDA recommended that we consider preparing
and filing new INDs for the frozen vaccine. At the recommendation of the FDA,
we decided to place our original INDs for M-Vax and O-Vax on inactive status,
given the FDAs view that the revisions to the manufacturing process, necessary
to address the FDAs concerns, would result in a new product from a regulatory
perspective and given the Agencys recommendation that we file new INDs for
indications utilizing the new product. Based upon the continuing interactions
with the FDA in 2002, we determined to file new INDs for the revised product
format for the AC Vaccine for melanoma and ovarian cancer. Our Philadelphia
facility was validated and cleared to begin processing clinical samples for
administration to patients in clinical trials. Due to a lack of funding at that
time, however, we decided not to initiate the clinical trials at that time.
Also
during 2002, based upon a negative reaction by authorities in Australia to an
application for product reimbursement for M-Vax, we determined that we would be
unable to support further the operation in Australia and a decision was made to
discontinue and liquidate the Australian joint venture companies. We had not
received formal rejection of our reimbursement application, but a panel of
oncologists selected by the regulatory authority in Australia had recommended
against governmental reimbursement for M-Vax in Australia. Subsequent to our
liquidation of the Australian entity, we received formal notification of our
rejection of reimbursement by the appropriate authorities. Our experience in
Australia demonstrated the importance of obtaining support for the technology
among the leading oncologists within a particular country or community, which
we were never able to achieve in Australia during that period.
On
April 13, 2007, we closed a private placement of 80,060,000 shares of
common stock at a purchase price of $0.125 per share with 25 accredited or
institutional investors. We received gross proceeds of $10,007,500. In
connection with the private placement, we also issued to the investors warrants
to purchase 80,060,000 shares of common stock at a warrant exercise price of
$0.15 per share. In addition, we agreed to pay up to $580,350 and to issue
warrants to purchase up to 6,190,400 shares of common stock at a warrant
exercise price of $0.15 per share to certain advisors relating to this private
offering. We received net proceeds from this private offering, after offering
related expenses, of approximately $9.3 million. We are using the net proceeds
of this private placement to continue to implement the plan of operation
described below.
Current Plan of Operation.
The following is
a summary of our plan of operation based on our current cash resources and
assuming that we raise between $10.0 million and $25.0 million in this
offering. The key components of our current plan of operation are:
|
|
|
Enroll
patients in our Phase III registration trial in the U.S. for M-Vax for the
treatment of Stage 3 and 4 melanoma patients, which trial will proceed under
the Special Protocol Assessment that we received from the U.S. FDA in October
2006.
|
|
|
|
Continue the
treatment of melanoma patients outside the U.S. on a compassionate use basis
with M-Vax.
|
|
|
|
Continue our
discussions with the European Medical Evaluations Agency and AFSSAPs, the FDA
equivalent regulatory bodies for the European Union and France, respectively,
regarding the regulatory requirements for the AC Vaccine and its continued
development in Europe and France.
|
|
|
|
Initiate
discussion with Japanese regulatory authorities regarding the regulatory
approval process for autologous products like our AC Vaccines and the
requirements for making M-Vax available for compassionate use in Japan.
|
14
Table of Contents
If we are able
to raise the full $25.0 million, we will also:
|
|
|
Continue our
Phase I-II clinical in the U.S. for L-Vax, for the treatment of patients with
resectable non-small cell lung cancer.
|
|
|
|
Initiate a
Phase I-II clinical trial in the U.S. for O-Vax, for the treatment of
patients with ovarian cancer.
|
If we are
unable to raise the full $25.0 million, we will be unable to initial a Phase
I-II clinical trial for O-Vax or to continue the current Phase I-II clinical
trial for L-Vax, in each instance unless we are able to partner with a company
with greater financial resources for the development of those products.
The
primary focus of our plan of operation for 2008 and 2009 will be the
development of M-Vax and the Phase III registration trial in the U.S. relating
to that product. In November 2007, with FDA authorization, we began our Phase
III registration trial for M-Vax. Until we raise additional capital, we will be
unable to promote this Phase III registration trial aggressively. In October
2006, the FDA issued to us a Special Protocol Assessment for the study,
agreeing that the proposed protocol, as designed, will allow us to gain
regulatory approval with the successful conduct of the study. In addition the
Special Protocol Assessment indicates that we may use response rate (using
modified RECIST criteria) as an acceptable surrogate endpoint as a basis to
obtain accelerated approval. RECIST means Response Evaluation Criteria in Solid
Tumors, as defined by the National Cancer Institute. The Special Protocol
Assessment is a written agreement between us and the FDA regarding the trial
design, the surrogate endpoints to be used as a basis for filing for
accelerated approval of M-Vax and the statistical analysis plan necessary to
support the full regulatory approval of M-Vax.
The
Phase III study will enroll up to 387 patients with stage 4 melanoma, who will
be assigned in a double-blind fashion at a 2:1 ratio to M-Vax or a placebo
vaccine. The primary endpoints of the study are best overall anti-tumor
response rate and the percentage of patients surviving two years. Secondary
endpoints of the study will include overall survival time, response duration,
percentage complete and partial responses, progression free survival and treatment
related adverse events.
In
December 2007, we successfully completed the Phase I-II clinical trial in the
U.S. for M-Vax for the treatment of Stage 3 and 4 melanoma patients. That study
was launched in June 2005. Patients were treated with M-Vax after being
assigned to one of four dosage arms, one of which was a zero dose. The study
was designed to evaluate four doses of M-Vax with doses defined by the number
of cells injected in each vaccine; the doses tested were: 5x106 cells (high
dose), 2.5x106 cells (medium dose), 0.5x106 cells (low dose), and zero cells
(zero dose). All dosages were administered according to a previously developed
optimum schedule, which included an induction dose without adjuvant followed by
low dose cyclophosphamide and then 6 doses admixed with the immunological
adjuvant, BCG. Endpoints of the study were safety and an immunological endpoint
of delayed-type hypersensitivity (DTH), which is a T-cell-mediated immune
response to autologous melanoma cells. Patients were tested for DTH response to
their own DNP-modified and unmodified melanoma cells prior to treatment and
after the initial seven weekly vaccine injections. DTH results were obtained at
2 ½-months, and the maximum duration of the study for an individual patient was
9 months. The study was also designed to demonstrate that the frozen
formulation of M-Vax is bio-equivalent to the original, freshly-prepared
autologous, hapten-modified vaccine.
The
high dose arm of vaccine was highly effective immunologically with positive DTH
responses to hapten-modified autologous melanoma cells observed in 22/29 (76%)
patients following a course of M-Vax; baseline DTH responses were negative, as
a condition of enrollment. In contrast, the zero dose arm was ineffective. Linear
regression analysis of DTH responses of all evaluable patients showed a clear
dose-response relationship when DTH responses for each patient were plotted
against the M-Vax dose received. These results are important, because
previously published studies by AVAX and others showed a statistically
significant relationship was seen between survival and induction of DTH after
M-Vax administration.
The
safety profile of M-Vax appeared to be very favorable. There were no serious
adverse events attributed to M-Vax. Non-serious adverse events were similar to
what has been observed in previous trials of the autologous, haptenized
vaccine: mild-moderate injection site reactions in all patients, mild nausea
from cyclophosphamide in some patients, and mild constitutional symptoms, such
as fatigue, in some patients after M-Vax administration.
15
Table of Contents
Eight
clinical sites in the U.S. participated in the Phase I-II clinical study of
M-Vax, and we are targeting up to 50 U.S. and European centers to participate
in the Phase III registration trial.
Our
current cash resources require that we significantly curtail our efforts to
enlist new clinical sites for the Phase III registration trial and to
significantly slow the patient enrollment in that trial until we are successful
in raising additional capital. We will use the proceeds of this offering
primarily to fund the additional costs associated with enlisting clinical sites
for and patient enrollment in the Phase III trial. If we are able to raise
$10.0 million in this offering, we estimate those proceeds plus our current
cash resources will be sufficient fund this plan of operation to the second
quarter of 2009 (with a goal of approximately 50% patient enrollment, or
approximately 195 patient) in the Phase III study, while if we are able to
raise $25.0 million in this offering, we anticipate that we will have
sufficient cash resources to fund our plan of operation into the first half of
2010 (with a goal of 100% patient enrollment in the study).
If
we are unable to raise $25.0 million, we will be unable to initiate a Phase
I-II clinical trial for O-Vax or to continue the current Phase I-II clinical
trial for L-Vax, in each instance unless we are able to partner with a company
with greater financial resources for the development of those products. If we
are successful in raising $25.0 million, we would expect to continue the Phase
I-II clinical study for L-Vax and to commence a Phase I-II clinical study for
O-Vax.
Even
if the Phase I-II clinical trials for L-Vax or O-Vax are completed successfully
and if we raise $25.0 million in this offering, we will not have the cash
resources to commence a Phase III trial for either of those products. Further
development of either product, including a Phase III registration trial, would
likely require that we seek to partner with a large pharmaceutical company in
that further and future commercialization of that product.
We
continually evaluate our plan of operation discussed above to determine the
manner in which we can most effectively utilize our limited cash resources. The
timing of completion of any aspect of our plan of operations is highly
dependant upon the availability of cash to implement that aspect of the plan
and other factors beyond our control. We believe our current cash resources
plus $10.0 million in this offering will fund this plan of operation to the
second quarter of 2009 and our current cash resources plus $25.0 million in
this offering will fund our plan of operation into the second half of 2010. The
full implementation of this plan of operation beyond those dates is dependent
upon us obtaining additional capital in the future.
We
are currently engaged in contract manufacturing and the development and
commercialization of biotechnology and pharmaceutical products and
technologies. These activities take advantage of the facilities and personnel
that we are required to maintain to ensure that we process our products in
accordance with cGMP requirements. With our current compassionate use and
ongoing and planned clinical activities, we anticipate that excess capacity
will continue to exist at our Lyon, France facility for the foreseeable future.
We
will continue to pursue additional contract manufacturing agreements in the
U.S. and France, which would provide us with additional revenue to fund our
operations and the costs of the facilities. We believe that we have developed
significant expertise in producing certain biological products for clinical and
development purposes, and that this expertise can be marketed by us to other
companies and research institutions engaged in clinical trials and product
development programs. In addition, we have invested significant amounts to
establish and maintain current Good Manufacturing Practices at our
manufacturing facilities in Philadelphia, Pennsylvania and Lyon, France. We
believe that services provided by these facilities may be valuable to other
companies that wish to avoid the significant cash outlays associated with
buying or building their own cGMP facilities. We currently utilize our
Philadelphia facility for logistical support in our current clinical trials and
for storage of samples. We anticipate reinitiating vaccine processing at this
facility in the future in support of larger planned studies.
Results of Operations
Fiscal
Year 2006 Compared to Fiscal Year 2005.
Revenue
recognized in 2006 was $734,774 compared to revenue in 2005 of $1,623,701. The
decrease in revenues was due to a lower amount of revenue being recognized in
the current year related to contract manufacturing than the prior year. This
decrease was necessary to focus our efforts on the launch of the two clinical
studies in the U.S. for M-Vax and L-Vax, as well as preparing for the filing of
a Phase III protocol with the FDA.
16
Table of Contents
During
2006, our research and development expenses increased 20.1% from $3,534,948 to
$4,244,268, largely as a result of the launch of the M-Vax and L-Vax clinical
studies that resulted in increase transportation costs related to shipping
tumors and vaccines plus costs incurred at the clinical sites for patient
treatment and evaluations. Expenses for the periods are broken out by region as
follows:
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|
|
|
2005
|
|
2006
|
|
|
|
|
|
|
|
United
States
|
|
$
|
1,327,911
|
|
$
|
2,225,226
|
|
France
|
|
|
2,207,037
|
|
|
2,019,042
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,534,948
|
|
$
|
4,244,268
|
|
|
|
|
|
|
|
|
|
In
the U.S., the expense increase related to costs incurred in executing the M-Vax
and L-Vax studies that include shipping costs for tumors and vaccines plus the
costs at the clinical sites for the patient treatments and evaluations. The
decrease in costs in France is the result of higher costs incurred in 2005 for
facility validation in preparation of the clinical studies that did not recur
in the current year. In addition there were personnel from the prior year that
were replaced in the current year at lower costs.
Selling,
general and administrative expenses increased approximately 2.85%, from
$1,933,911 for the year ended 2005 to $1,989,188 for the year ended 2006.
Expenses for the periods are broken out by region as follows:
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|
|
|
2005
|
|
2006
|
|
|
|
|
|
|
|
United
States
|
|
$
|
1,357,338
|
|
$
|
1,461,491
|
|
France
|
|
|
576,573
|
|
|
527,697
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,933,911
|
|
$
|
1,989,188
|
|
|
|
|
|
|
|
|
|
In
the U.S., the increase in costs is primarily the result of recording the
reversal of an accrual of legal fees in 2005, which was partially offset by
decreases in salary expenses plus patents costs. In France the decreased costs
related to no longer incurring marketing costs associated with the OPI contract
that were incurred for the first half of 2005. These cost decreases were
partially offset by increases in administrative salaries incurred in the
current year with a higher allocation of the general managers salary to
administration.
Interest
income increased from $141,390 earned in 2005 to $143,182 in 2006. The increase
is the function of higher interest rates with the overall rise in short-term
interest rates, which was partially offset by a lower average invested balance
during the year.
We
anticipate our spending over the next 12 months for research and development
expenses will increase as compared with 2006, as we continue to implement and
accelerate the plan of operation described above.
Three
and Nine Months Ended September 30, 2007, Compared to Three and Nince Months
Ended September 30, 2006.
Revenues recognized in the
three and nine months ended September 30, 2007, were $95,877 and $299,193,
respectively, compared with revenues of $96,178 and $522,711, respectively for
the same periods in 2006. Current year revenues declined due to a decrease in
compassionate use sales and a decline in contract manufacturing revenue.
17
Table of Contents
For
the first nine months of 2007, our research and development expenses increased
to $3,402,404 from $3,162,049 for the same nine months in 2006. Expenses for the periods are broken out by
region as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
|
2006
|
|
2007
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
537,276
|
|
$
|
902,386
|
|
$
|
1,666,477
|
|
$
|
1,954,577
|
|
France
|
|
|
467,065
|
|
|
448,521
|
|
|
1,495,572
|
|
|
1,447,827
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,004,341
|
|
$
|
1,350,907
|
|
$
|
3,162,049
|
|
$
|
3,402,404
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
increase in the three and nine month costs in the U.S. relate to site
initiation costs associated with the Phase III study that includes the hiring
of a contract research organization for site recruitment and accrual. In
addition, in the current year we added one additional research nurse for the
assistance of site management for our ongoing Phase I-II studies and the oversight
of our Phase III study. In Europe, there was a slight cost decrease noted
during the three and nine month periods. The decrease was due to decline in
manufacturing costs with the stopping of accrual for the Phase I-II melanoma
study in the third quarter and the bulk of the study arms having reached full
enrollment. This decrease was partially offset by increased costs seen in
bringing certain product release tests in-house that required the purchase and
validation of equipment and procedures and a 12% increase in the Euro exchange
rate.
For
the first nine months of 2007, our selling, general and administrative expenses
increased to $1,813,479 from $1,442,897 for the same nine months in 2006.
Expenses for the periods are broken out by region as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
|
2006
|
|
2007
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
392,997
|
|
$
|
587,116
|
|
$
|
1,127,868
|
|
$
|
1,451,891
|
|
France
|
|
|
102,371
|
|
|
132,170
|
|
|
315,029
|
|
|
361,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
495,368
|
|
$
|
719,286
|
|
$
|
1,442,897
|
|
$
|
1,813,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In
the U.S., selling, general and administrative costs increased for the three and
nine-month period due to a $90,000 expenditure related to the recruitment of an
additional member of the board of directors, and increased board costs related
to meetings during the period that did not occur in the prior year. In
addition, there were increased costs related to salary adjustments grated to
senior management and the addition of an office manager in the current year.
Finally, increased costs were incurred related to patents, trademarks and
securities counsel during the current year.
In
France, cost increases for the three and nine-month period related to exchange
rate differences of 12% in the current year plus increased costs associated
with additional personnel costs supporting administrative and marketing
activities. There were also increased legal costs associated with the
appointment of a new general manager in the current year and the associated
statutory filings required in France.
We
anticipate that over the next 12 months, research and development expenses will
increase as compared with 2007 due to planned increases in the development
activities related to the AC Vaccine, assuming we are able to raise additional
capital.
Liquidity and Capital Resources
We
presently anticipate that our current cash resources will be sufficient to fund
operations through May 2008, assuming that we significantly slow our current
development plans until we raise additional capital. Our current cash resources
require that we significantly curtail our efforts to enlist new clinical sites
for the Phase III registration trial and to significantly slow the patient
enrollment in that trial until we are successful in raising additional capital.
We will use the proceeds of this offering primarily to fund the additional
costs associated with enlisting clinical sites for and patient enrollment in the
Phase III trial. If we are able to raise $10.0 million in this offering, we
estimate those proceeds plus our current cash resources will be sufficient fund
this plan of operation to the second
quarter of 2009 (with a goal of approximately 50% patient enrollment, or
approximately 195 patient) in the Phase III study, while if we are able to
raise the full $25.0 million in this offering, we anticipate that we will have
sufficient cash resources to fund our plan of operation into the first half of
2010 (with a goal of 100% patient enrollment in the study).
18
Table of Contents
If
we are unable to raise the full $25.0 million, we will be unable to initiate a
Phase I-II clinical trial for O-Vax or to continue the current Phase I-II
clinical trial for L-Vax, in each instance unless we are able to partner with a
company with greater financial resources for the development of those products.
If we are successful in raising the full $25.0 million, we would expect to
continue the Phase I-II clinical study for L-Vax and to commence a Phase I-II
clinical study for O-Vax.
Even
if the Phase I-II clinical trials for L-Vax or O-Vax are completed successfully
and if we raise $25.0 million in this offering, we will not have the cash
resources to commence a Phase III pivotal trial for either of those products.
Further development of either product, including a Phase III registration
trial, would likely require that we seek to partner with a large pharmaceutical
company in that further and future commercialization of that product.
We
continually evaluate our plan of operation discussed above to determine the
manner in which we can most effectively utilize our limited cash resources. The
timing of completion of any aspect of our plan of operations is highly dependant
upon the availability of cash to implement that aspect of the plan and other
factors beyond our control. We believe our current cash resources plus $10.0
million in this offering will fund this plan of operation to the second quarter
of 2009 and our current cash resources plus $25.0 million in this offering will
fund our plan of operation into the second half of 2010. The full
implementation of this plan of operation beyond those dates is dependent upon
us obtaining additional capital in the future.
If
our current and planned clinical trials for the AC Vaccine in the U.S. and
Europe do not demonstrate continuing progress toward taking one or more
products to market, our ability to raise additional capital to fund our product
development efforts would likely be seriously impaired. The ability of a
biotechnology company, such as AVAX, to raise additional capital in the
marketplace to fund its continuing development operations is conditioned upon
the company continuing to move its development products toward ultimate
regulatory approval and commercialization. If in the future we are not able to
demonstrate adequate progress in the development of one or more products, we
will not be able to raise the capital we need to continue our then-current business
operations and business activities, and we will likely not have sufficient
liquidity or cash resources to continue operating.
We
conduct our capital raising efforts in U.S. dollars, while a significant
portion of our revenues and expenses are generated and incurred in currencies
other than U.S. dollars, mainly Euros. To the extent that we are unable to
match revenues received in foreign currencies with costs paid in the same
currency, exchange rate fluctuations in any such currency could have an adverse
effect on our results of operations and cash flows.
Because
our working capital requirements depend upon numerous factors, including
progress of our research and development programs, pre-clinical and clinical
testing, timing and cost of obtaining regulatory approvals, changes in levels
of resources that we devote to the development of manufacturing and marketing
capabilities, competitive and technological advances, status of competitors,
and our ability to establish collaborative arrangements with other
organizations, there can be no assurance that our current cash resources will
be sufficient to fund our operations beyond May 2008. Because we have no
committed external sources of capital, and expect no significant product revenues
for the foreseeable future, we will require additional financing to fund future
operations or will need to enter into contract manufacturing relationships on
terms favorable to us. There can be no assurance, however, that we will be able
to obtain the additional funds sought in this offering or attract contract
manufacturing relationships on acceptable terms, if at all. If additional funds
are not raised by the end of April 2008, we will have to curtail our
initiatives beyond that point.
Critical Accounting Policies
Our
discussion and analysis of our financial condition and results of operations
are based on our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the U.S. The
preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities and expenses
and related disclosure of contingent assets and liabilities. We review our
estimates on an ongoing basis. We base our estimates on historical experience
and on various other assumptions that we believe to be reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities. Actual results may differ from
these estimates under different assumptions or conditions. Our accounting
policies are described in more detail in
Note
1
to our consolidated financial statements. We have identified the
following as the most critical accounting policies and estimates used in the
preparation of our consolidated financial statements.
19
Table of Contents
Goodwill.
In accordance with Statement of
Financial Accounting Standards, or SFAS, No. 142, Goodwill and Other Intangible
Assets, we do not amortize goodwill. Instead, we review goodwill for impairment
at least annually and when events or changes in circumstances indicate a
reduction in the fair value of the reporting unit to which the goodwill has
been assigned. Conditions that necessitate a goodwill impairment assessment
include (i) a significant adverse change in legal factors or in the business
climate, (ii) an adverse action or assessment by a regulator, (iii)
unanticipated competition, (iv) a loss of key personnel, or (v) the presence of
other indicators that would indicate a reduction in the fair value of our
Genopoeitic subsidiary to which the goodwill has been assigned. SFAS No. 142
prescribes a two-step process for impairment testing of goodwill. The first
step of the impairment test is used to identify potential impairment by
comparing the fair value of the entity to which the goodwill has been assigned
to its carrying amount, including the goodwill. Such a valuation requires
significant estimates and assumptions, including estimating future cash inflows
from contracts and other sources, and developing appropriate discount rates and
probability rates. If the carrying value of the reporting unit exceeds the fair
value, the second step of the impairment test is performed in order to measure
the impairment loss.
Our
goodwill had a carrying value of $188,387 at September 30, 2007, resulting from
our acquisition of Genopoeitic in August 2000. We performed our annual goodwill
impairment test in accordance with SFAS No. 142 and determined that the
carrying amount of goodwill was recoverable. We considered internal
risk-adjusted cash flow projections, which utilize several key assumptions,
including estimated timing of cash inflows into Genopoeitic.
Impairment
of Long-Lived Assets.
Long-lived assets to be held and
used, including property and equipment and intangible assets subject to
amortization, are reviewed for impairment at least annually and whenever events
or changes in circumstances indicate that the carrying amount of the assets
might not be recoverable. Conditions that would necessitate an impairment
assessment include a significant decline in the market price of an asset or
asset group, a significant adverse change in the extent or manner in which an
asset or asset group is being used, a significant adverse change in legal
factors or in the business climate that could affect the value of a long-lived
asset or asset group, or the presence of other indicators that would indicate
that the carrying amount of an asset or asset group is not recoverable.
Determination of recoverability is based on the undiscounted future cash flows
resulting from the use of the asset or asset group and its eventual
disposition. The determination of the undiscounted cash flows requires
significant estimates and assumptions including determining the timing and
expected costs to complete in-process projects, projecting regulatory approvals
and estimating future cash inflows from product sales and other sources. In the
event that such cash flows are not expected to be sufficient to recover the
carrying amount of the asset or asset group, the carrying amount of the asset
is written down to its estimated fair value. Following our long-lived asset
impairment review for the fiscal year ended December 31, 2006, we have
determined that no impairment of long-lived assets existed.
Research
and Development Costs.
Research and development costs,
including payments related to research and license agreements, are expensed
when incurred. Contractual research expenses are recorded pursuant to the
provisions of the contract under which the obligations originate. Research and
development costs include all costs incurred related to the research and
development, including manufacturing costs incurred, related to our research
programs. We are required to produce our products in compliance with current
Good Manufacturing Practices, which requires a minimum level of staffing,
personnel and facilities testing and maintenance. Based upon our current
staffing level required to be in compliance with cGMP, we have excess capacity.
Utilizing this excess capacity, revenue is generated in the form of contract
manufacturing engagements. Accordingly, costs associated with the contract
manufacturing revenues are not broken out from our research and development
costs, as these costs would not differ even if the contracts were not in place.
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Impact of Recently Issued Accounting
Standards
In
September 2006, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting Standards No. 157, Fair Value Measurements (FAS
157). FAS 157 defines fair value, establishes a framework for measuring fair
value in GAAP, and expands disclosures about fair value measurements. FAS 157
is effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. We are
evaluating the impact, if any, of adopting FAS 157 on our consolidated
financial statements.
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities Including an Amendment of FASB
Statement 115 (FAS 159). FAS 159 permits entities to choose to measure many
financial instruments and certain other items at fair value. Entities that
elect the fair value option will report unrealized gains and losses in earnings
at each subsequent reporting date. The fair value option may be elected on an
instrument-by-instrument basis, with few exceptions. FAS 159 also establishes
presentation and disclosure requirements to facilitate comparisons between
companies that choose different measurement attributes for similar assets and
liabilities. FAS 159 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. We are is evaluating the impact, if
any, of adopting FAS 159 on our consolidated financial statements.
In
June 2007, the FASB ratified Emerging Issues Task Force (EITF) Issue No.
07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to
Be Used in Future Research and Development Activities (Issue 07-3), which
addresses the accounting for nonrefundable advance payments. The EITF concluded
that nonrefundable advance payments for goods or services to be received in the
future for use in research and development activities should be deferred and
capitalized. The capitalized amounts should be expensed as the related goods
are delivered or the services performed. If an entitys expectations change
such that it does not expect it will need the goods to be delivered or the
services to be rendered, capitalized nonrefundable advance payments should be
charged to expense. Issue 07-3 is effective for new contracts entered into
during fiscal years beginning after December 15, 2007, including interim
periods within those fiscal years. We are evaluating the impact, if any, of
adopting Issue 07-3 on our consolidated financial statements.
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B
USINESS
General
Overview
We
are a development stage biotechnology company specializing in the development
and future commercialization of individualized vaccine therapies and other
technologies for the treatment of cancer. Our vaccine consists of autologous
(the patients own) cancer cells that have been treated with a chemical
(haptenized) to make them more visible to the patients immune system. We
refer to our cancer vaccine technology as autologous cell vaccine immunotherapy
and to the vaccine as the AC Vaccine. Our previous clinical trials for the AC
Vaccine have concentrated on melanoma, ovarian carcinoma, which are our primary
indications, and non-small cell lung cancer. We refer to our AC Vaccine
candidates as:
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M-Vax for the
treatment of melanoma. The current clinical status of our M-Vax program is as
follows:
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Phase I-II
Multiple dose safety and efficacy study launched in June 2005 and completed
in December 2007.
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Phase III
Registration study enrollment commenced in November 2007. The study is the
subject of a Special Protocol Assessment granted by the U.S. Food and Drug
Administration (FDA).
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L-Vax for
the treatment of non-small cell lung cancer. The current clinical status of
our L-Vax program is as follows:
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Phase I-II
Multiple dose safety and efficacy study launched in December 2005.
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O-Vax for the treatment of ovarian cancer.
The current clinical status of our O-Vax program is as follows:
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Phase I-II
Multiple dose safety and efficacy study anticipated to launch in 2008,
subject to obtaining sufficient financing to implement fully our plan of
operation described in this prospectus.
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We
also offer biological manufacturing services to other biotechnology and
pharmaceutical companies. These services are provided utilizing the same
facilities and personnel that produce our products for clinical and commercial
purposes. In Europe, and more recently in South America, we have made M-Vax
available for patient treatment on a compassionate use basis. Compassionate use
is considered for patients who have failed to respond to accepted standards of
care for their cancer and are facing a prognosis of imminent death. Although it
is not the primary purpose of compassionate use of our vaccine, we receive
payments for the vaccine from the hospitals that contract for the acquisition
of the vaccine.
In
1995, we identified the AC Vaccine research being conducted by Dr. David Berd,
an oncologist and professor at Thomas Jefferson University in Philadelphia, and
licensed the rights to Dr. Berds research. Since then, we have focused our
efforts on the development of an immunotherapy for the treatment of cancer, the
AC Vaccine technology. On November 1, 2004, Dr. Berd joined our company as our
Chief Medical Officer.
In
August 2000, we acquired Genopoietic S.A. and its corporate affiliate, based in
Lyon, France, which developed cell and gene-based therapies in collaboration
with Pierre et Marie Curie University and Centre National de la Recherche
Scientifique. As part of that acquisition, we acquired a biological clean room
facility in Lyon, France, at which we now conduct all AC Vaccine manufacturing.
In the last three years, much of our development and manufacturing efforts
relating to the AC Vaccine have shifted to our Lyon facility, due to the
expertise and staffing at that facility and recent developments in France and
other European countries that should facilitate development of autologous
products, such as the AC Vaccine, in Europe.
The
Lyon facility has been inspected, and is the subject of ongoing inspections, by
AFSSAPs (the French equivalent of the U.S. Food and Drug Administration) and
received the designation of Etablissement Pharmaceutique in 2002 and obtained
the designation Etablissement Thérapies Gèniques et Cellulaires in 2004. The
Etablissement Pharmaceutique designation is required for the production of any
commercial product to be sold in France and throughout Europe. The
Etablissement Therapies Geniques et Cellulaires designation is required in
France for the commercial production of cell and gene therapy products.
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Current Cancer
Therapies
Cancer
is a diverse and complex disorder with multiple causes and variable outcomes.
Genetic predisposition, environmental factors and diet are among the numerous
contributing factors that are associated with the development and evolution of
this heterogeneous disease. Each year in the U.S. alone, over 1.5 million new
individuals are diagnosed with various forms of cancer and, as our overall life
span increases, the incidence of the disease is expected to increase.
In
a healthy person, tissues and organs consist of cells that are, in part,
regulated by the immune system. Normal cell function is characterized by cell
growth, cell division and then programmed cell death (the latter referred to as
apoptosis) as new cells are generated and function in place of the original
cell. Cancer is characterized by the unregulated growth of cells that
proliferate as tumors, which can metastasize (i.e., spread) throughout the
body, resulting in distant deposits of tumor cells, called metastases. Cancer
cells have adopted many mechanisms by which they can elude the defense systems
of the body. A significant feature of their proliferation is their ability to
evade recognition by the patients immune system. The metastatic tumors disrupt
normal tissue and organ functions, which in the worst circumstances leads to
the death of the patient.
We
believe that for a therapy to be effective it must eliminate or control the
growth of the cancer, both at its site of origin and at the site of metastases.
Patients with cancer typically undergo a first line of treatment through
surgical removal of tumors. Treatments that follow surgery (referred to as
adjuvant treatments) include radiation, hormone therapy and chemotherapy.
Initial surgery and radiation therapy treat cancer at its origin, but are
limited because certain tissues cannot be removed surgically or do not tolerate
radiation. Moreover, cancers frequently spread prior to detection, and surgery
and radiation cannot control metastases. Chemotherapy and hormonal therapy are
frequently used to treat tumor metastases. These therapies, however, can cause
severe side effects, including damage to normal tissue. Additionally,
chemotherapy and hormonal therapy may shrink tumors, but rarely eliminate them
completely. Our approach to development of cancer therapies is to find targets
that are novel or to discover compounds that are structurally different from
existing therapies with the intent of making the treatments more specific and
less toxic.
The Immune System
The
immune system is involved intimately in the regulation of the growth of cells
and tissues within the body as well as acting as a natural defense against
disease. These functions are performed by a variety of specialized cells. These
cells recognize specific chemical structures, called antigens, which are found
on disease-causing agents, including tumors. Antigens trigger an immune
response, which results in the eventual removal of antigen from the body.
The
type of immune response is characterized by the way the response was initiated
through specialized cells known as lymphocytes. There are two main categories
of lymphocytes: B-lymphocytes, or B-cells, and T-lymphocytes, or T-cells. Each
category of lymphocytes has a different role in the immune response. T-cells
combat disease by killing antigen bearing cells directly or by making chemicals
called cytokines that work indirectly. In this way, T-cells eliminate cancers and
virally infected tissue. T-cell immunity is also known as cell-mediated
immunity and is commonly thought to be a key defense against tumors and cells
chronically infected by viruses. In contrast, activation of B-cells leads to
the production of specific antibodies. The antibodies are secreted by B-cells
and bind to antigen found on pathogens or tumor cells resulting in their
destruction.
Cancerous
cells are cells that have changed (or mutated) so that they express certain
antigens that may or may not be recognized as foreign by the immune system. We
believe that the antigens are distinct for each patient so that effective
immunization can only be accomplished by using each patients own cancer cells.
In addition, we believe that by a process called haptenization, the cancer
antigens are changed so that they become visible to the patients immune
system. This allows the immune system to mount a response against the cancer
antigens.
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Development and Clinical Programs
Autologous Cell
Vaccine Immunotherapy (AC Vaccine)
The
only major program that we are presently developing for the treatment of cancer
is our AC Vaccine technology, licensed from Thomas Jefferson University. The AC
Vaccine immunotherapy technology is based on the concept of haptenization. This
idea has a long history, beginning with the work of the immunologist and Nobel
laureate Karl Landsteiner in the 1920s. He and other scientists showed in
animal models that attaching a small chemical (a hapten) to a protein allowed that
protein to be recognized by the immune system even if the animals were
originally unresponsive to the protein. This work has been expanded by a number
of researchers in various animal models. We now understand that a large number
of T-cells (or T-lymphocytes, which are white blood cells that are crucial in
tumor rejection) react against the haptenized material and that a small
percentage of the T-cells also react against the unmodified, natural material.
We believe that tumor antigens, which are proteins, are similarly affected by
haptenization.
Our
AC Vaccine technology utilizes the patients tumor as the basis for a
therapeutic vaccine. By extracting cancer cells from a tumor and then treating
them with a hapten called dinitrophenyl (DNP), a vaccine is prepared that
should be able to elicit a systemic immune response to the unmodified, native
cancer cells. The induction of an immune response has been documented in a
number of scientific publications. We believe that the best test of tumor immunity
in patients is Delayed Type Hypersensitivity (DTH). DTH has long been used as
a test for immunity to microbes, such as tuberculosis and is familiar to
patients as the Tine test or PPD. DTH to cancer cells is tested in the same
way, except that the patients cancer cells are the test agent. We have
demonstrated that the DTH test to cancer cells is meaningful by showing a
strong statistical relationship between the intensity of DTH and clinical
outcomes, especially 5-year survival.
Our
leading AC Vaccine product candidate is M-Vax, which is designed as an
immunotherapy for the post-surgical treatment of late stage (stages 3 and 4)
melanoma. Melanoma is a highly malignant tumor that can spread so rapidly that
it can be fatal within months of diagnosis. According to a report published in
the British Journal of Dermatology, worldwide, the number of cases of melanoma
is increasing faster than any other cancer. Although there are several
causative factors, rising exposure by the general population to ultraviolet
radiation in sunlight appears to be the most significant. According to the
American Cancer Society, it is estimated that in 2007 there will be 59,940 new
cases of melanoma in the U.S. and there will be an estimated 8,110 deaths
related to melanoma.
Melanoma
patients may be categorized according to the following staging system:
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Stage
1lesion less than 1.5mm thickness and no apparent spreading (metastasis)
from primary cancer site;
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Stage 2lesion greater than 1.5mm thickness
and no apparent spreading from primary cancer site;
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Stage 3metastasis to regional draining
lymph nodes; and
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Stage 4distant (bloodbourne) metastasis.
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Historically,
patients with stage 3 melanoma have been treated with surgery followed by a
year-long regimen of the drug, alpha interferon. This is a biological drug and
currently the only FDA-approved post-surgical treatment for patients with stage
3 melanoma. While alpha interferon has been proven to prolong relapse-free
survival, its impact on overall survival has been questioned. Further, use of
alpha interferon can be associated with many severe side effects, often leading
to either reduction in dosage or complete discontinuation before the full
course of treatment is completed. Due to limited efficacy and highly toxic side
effects, chemotherapy has not been widely used in the treatment of stage 3
patients. Stage 4 melanoma is usually treated with chemotherapy or cytokines,
such as interferon or IL-2. Long-term remissions, however, are unusual and
five-year survival rate for stage 4 melanoma is very low.
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Clinical Results
Achieved with the AC Vaccine
We
believe that M-Vax is the first immunotherapy to suggest, from clinical trial
results, that its use may result in a significant improvement in the survival
rate for patients with stage 3 melanoma. There have been 214 patients with
stage 3 melanoma treated with M-Vax, who had already had their lymph node
tumors excised and processed into vaccines. These studies are mature, in that
all surviving patients have completed the planned 5-year follow-up. The 5-year
overall survival of these patients is 44%. This compares with the historical
post-surgical survival rates of approximately 2232%. In a total of over 600
patients treated with the AC Vaccine by us or at Thomas Jefferson University in
clinical trials, no serious side effects have been reported. We believe that
only relatively minor side effects, such as brief bouts of mild nausea and
soreness and swelling at the site of the injection, have been observed to date.
Patients
who receive M-Vax may develop an immune response to their own melanoma cells as
measured by a DTH test to autologous melanoma cells. DTH, which is manifest by
the development of a hive at the site of injection of the test material, is
known to be a measure of the activity of T-lymphocytes, which are white blood
cells that are crucial in tumor rejection. In the stage 3 adjuvant studies,
patients who developed positive DTH to their own melanoma cells that were not
modified with the hapten had a significantly greater chance of 5-year year
survival than those who did not (59% vs. 29%, P<.001). This difference is
highly statistically significant. In all of these patients, DTH to autologous
melanoma cells was tested in conjunction with control materials that indicated
that all patients had functioning immune systems and that the DTH reactions
were not artifactual.
We
believe that the DTH test can be used as a surrogate marker of vaccine
activity. In our planned future clinical activities, we will propose to use the
DTH test as a primary endpoint to measure activity of the vaccine. As we expand
the use of the vaccine into new indications our intent is to use DTH response
as the primary indicator of activity of the vaccine and the basis upon which we
will proceed further with clinical development. Use of DTH response as an
indicator of vaccine activity significantly decreases the duration of studies
and, thus, reduces the cost of conducting clinical trials and reaching a
primary endpoint.
As
is noted below, we currently treat patients outside the U.S. on a compassionate
use basis. Certain clinicians have reported to us that they have administered
the M-Vax vaccine with IL-2 or interferon, which are two current cytokine
therapies available to melanoma patients. These European clinicians have
reported to us what they believe were positive clinical responses to the
combined treatment regimes. Additional published work in a peer-reviewed
journal by another clinician who has treated patients with their DNP modified
tumor cells, using techniques similar to M-Vax, followed by IL-2 reported
response rates in patients of 35%. This compares with previously reported
response rates of patients treated with M-Vax alone of 11%. Response rates are
defined by clinical criteria known as RECIST (or Response Evaluation Criteria
in Solid Tumors, as defined by the National Cancer Institute). This means that the
patients tumors have decreased by 50% or more from their base-line evaluation
(partial response), or that their tumors have completely disappeared (complete
response).
These
published and unpublished reports were used by us in developing our Phase III
registration trial for M-Vax, including the submissions to the FDA that
supported the Special Protocol Assessment agreement we have with the FDA for
accelerated approval of M-Vax.
Current Commercial
and Clinical Activities with the AC Vaccine
The
FDA has authorized us to begin our Phase III registration study of M-Vax.
Related to the protocol, the FDA has issued to us a Special Protocol Assessment
for the study, agreeing that the proposed protocol, as designed, will allow us
to gain regulatory approval with the successful conduct of the study. In
addition the Special Protocol Assessment indicates that we may use response
rate (using modified RECIST criteria) as an acceptable surrogate endpoint as
a basis to obtain accelerated approval. The Special Protocol Assessment is a
written agreement between us and the FDA regarding the trial design, surrogate
endpoints to be used as a basis for filing for accelerated approval of M-Vax
and the statistical analysis plan necessary to support the full regulatory
approval of M-Vax.
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The
Phase III study will enroll up to 387 patients with stage 4 melanoma, who will
be assigned in a double-blind fashion at a 2:1 ratio to M-Vax or a placebo
vaccine. The M-Vax arm will consist of an initial dose of M-Vax (autologous
DNP-modified tumor cells) followed by cyclophosphamide (CY) and six weekly
doses of M-Vax administered with Bacillus of Calmette and Guerin (BCG).
Following vaccine administration, patients will receive a course of low dose
IL-2 administered subcutaneously. Patients assigned to the control group will
receive a treatment identical to the M-Vax group, except that a placebo vaccine
will replace M-Vax. The primary endpoints of the study are best overall
anti-tumor response rate and the percentage of patients surviving 2 years.
Secondary endpoints of the study will include overall survival time, response
duration, percentage complete and partial responses, progression free survival
and treatment related adverse events.
In
December 2007, we successfully completed the Phase I-II clinical trial in the
U.S. for M-Vax for the treatment of Stage 3 and 4 melanoma patients. That study
was launched in June 2005. Patients were treated with M-Vax after being
assigned to one of four dosage arms, one of which was a zero dose. The study
was designed to evaluate four doses of M-Vax with dose defined by the number of
cells injected in each vaccine; the doses tested were: 5x106 cells (high dose),
2.5x106 cells (medium dose), 0.5x106 cells (low dose), and zero cells (zero
dose). All dosages were administered according to a previously developed
optimum schedule, which included an induction dose without adjuvant followed by
low dose cyclophosphamide and then 6 doses admixed with the immunological
adjuvant, BCG. Endpoints of the study were safety and an immunological endpoint
of delayed-type hypersensitivity (DTH), which is a T-cell-mediated immune
response to autologous melanoma cells. Patients were tested for DTH response to
their own DNP-modified and unmodified melanoma cells prior to treatment and
after the initial seven weekly vaccine injections. DTH results were obtained at
2 ½-months, and the maximum duration of the study for an individual patient was
9 months. The study was also designed to demonstrate that the frozen
formulation of M-Vax is bio-equivalent to the original, freshly-prepared
autologous, hapten-modified vaccine.
The
high dose arm of vaccine was highly effective immunologically with positive DTH
responses to hapten-modified autologous melanoma cells observed in 22/29 (76%)
patients following a course of M-Vax; baseline DTH responses were negative, as
a condition of enrollment. In contrast, the zero dose arm was ineffective.
Linear regression analysis of DTH responses of all evaluable patients showed a
clear dose-response relationship when DTH responses for each patient were
plotted against the M-Vax dose received. These results are important, because
previously published studies by AVAX and others showed a statistically
significant relationship was seen between survival and induction of DTH after
M-Vax administration.
The
safety profile of M-Vax appeared to be very favorable. There were no serious
adverse events attributed to M-Vax. Non-serious adverse events were similar to
what has been observed in previous trials of the autologous, haptenized
vaccine: mild-moderate injection site reactions in all patients, mild nausea
from cyclophosphamide in some patients, and mild constitutional symptoms, such
as fatigue, in some patients after M-Vax administration.
Eight
clinical sites in the U.S. participated in the Phase I-II clinical study of
M-Vax, and we are targeting up to 50 U.S. and European centers to participate
in the Phase III registration trial.
In
March 2005, we submitted a Biological License Application filing with AFSSAPs
(the French counterpart of the U.S. FDA) for the treatment of stage 3 and 4
melanoma patients in France. In February 2006, AFSSAPs notified us that the
filing was not approvable with the current data and that additional data would
be necessary to support an approval. We are continuing to work with AFSSAPs to
define what additional data are necessary and to evaluate the opportunities to
treat patients in France under a compassionate use protocol while we are
generating the additional data.
We
have previously conducted clinical trials to evaluate the safety and efficacy
of M-Vax and O-Vax (our AC Vaccine for ovarian cancer). In March and April
2001, we received first oral notification and then written confirmation from
the FDA that clinical activities then underway for both our M-Vax and O-Vax
autologous cancer vaccines were placed on clinical hold pending further review
by the agency. The written notification from the FDA confirming the clinical
hold identified the specific issues that the FDA wanted addressed, which dealt
primarily with the sterility of autologous tumors received by us at the
Philadelphia facility and the assurance that vaccines being provided to
patients would meet FDA sterility guidelines.
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In
conjunction with the clinical hold, the FDA conducted an inspection of our
manufacturing facility in Philadelphia, which inspection was completed in May
2001. As a result of that facility inspection, we received a Form 483, which is
a finding of manufacturing facility deficiencies, to which we initially
responded at the end of June 2001. The issues raised in the Form 483 were
essentially consistent with those in the clinical hold letters, focusing
primarily with the sterility of autologous tumors received by us at the
Philadelphia facility, the handling of sterile and non-sterile tumors and
assurance that vaccines being provided to patients would meet FDA sterility
guidelines. No significant new areas of concern were identified in the Form
483.
In
developing our response to the FDA clinical hold letters and the Form 483, we
identified and began to implement a number of product development initiatives
related to the AC Vaccine technology. As a result, we determined certain
product improvements to the vaccine could be instituted that would address
certain concerns of the FDA and make the vaccine more viable from a regulatory
and commercial perspective. Throughout the remainder of 2001 and into 2002, we
continued to evaluate (1) the prospect of freezing the haptenized cells for
distribution to the end user, (2) steps that could be taken to help ensure that
final released vaccines prepared by us are sterile and (3) tests to determine the
minimal number of cells necessary for the vaccine to be effective. Based upon
the results of these efforts, we reengineered the manufacturing steps to create
and release the vaccine technology to take advantage of these potential product
improvements.
In
working with the FDA to resolve the issues identified as part of the clinical
hold, we concluded that (1) it would no longer be feasible to continue the
clinical development of the original AC Vaccine format without the ability to
ensure clinical samples have completed sterility testing prior to
administration (referred to as the fresh vaccine product format), and (2) a
revised product format needed to be established, tested and reviewed by the FDA
which allowed us to test the vaccine for sterility prior to administration of
the vaccine to patients. Through these research and development activities we
developed a new product format for the production and distribution of the AC
Vaccine, referred to as the frozen vaccine technology. Based upon the changes
to the manufacturing of the product, the FDA recommended that we consider
preparing and filing new Investigational New Drug Applications for the frozen
vaccine. At the recommendation of the FDA, we inactivated the INDs for M-Vax
and O-Vax, given the FDAs view that the revisions to the manufacturing
process, necessary to address the FDAs concerns, would result in a new product
from a regulatory perspective and given the FDAs recommendation that we file
new INDs for indications utilizing the new product.
Based
upon the continuing interactions with the FDA, in 2002, we determined it was
necessary to file new INDs for the revised product format for the AC Vaccine
for melanoma and ovarian cancer, which IND filings were accepted by the FDA.
Our Philadelphia facility was cleared to begin processing clinical samples for
administration to patients in clinical trials. Due to a lack of funding at that
time, we decided not to initiate the clinical trials at that time.
Non-Small-Cell Lung
Cancer
According
to the American Cancer Society, lung cancer is the leading cause of cancer
death for both men and women. The American Cancer Society estimates that there
will be 213,380 new cases of lung cancer and 160,390 deaths from lung cancer in
the U.S. in 2007. Historically, 80-85% of lung cancer cases have been non-small
cell lung cancer (NSCLC). The low cure rate associated with NSCLC can be
attributed to the absence of effective screening, the propensity for early
spread, and the lack of effective treatment options for metastatic spread.
We
believe that NSCLC may be a good target for our AC Vaccine immunotherapy
approach. Lung cancers are chemically-induced, which increases the likelihood
that they will express antigens recognized by the immune system. Also, in
clinical trials of M-Vax, we observed that melanoma lung metastases were more
likely to respond well to the AC Vaccine than metastases in other sites.
In
February 2004, we announced a collaboration with the thoracic surgery team at
the University of Pennsylvania Cancer Center. This collaboration allowed us to
complete a feasibility study of the autologous, hapten-modified AC Vaccine for
NSCLC. The study demonstrated that vaccines could be manufactured successfully
from most early stage tumors. All the vaccines manufactured as part of the
feasibility study also passed sterility tests. These results formed the basis
of our Phase I-II clinical trial of L-Vax to determine the safety of an
autologous, hapten-modified NSCLC vaccine and its ability to induce a positive
DTH response, as described below.
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In
November 2005, the FDA approved our IND for the treatment of resectable NSCLC.
We commenced a Phase I-II clinical study of L-Vax for the treatment of NSCLC at
the University of Pennsylvania Cancer Center in January 2006. The study
subjects will be patients with completely resectable primary NSCLC (stage 1, 2,
and early 3). They will undergo standard surgical resection, and the tumor
tissue will be sent to us for manufacture of the L-Vax vaccine. Eligible
patients will be assigned to one of three dosage groups. The schedule of
administration will be the same as the one optimized in previous melanoma
trials. The regimen for the NSCLC Phase I-II study includes low dose
cyclophosphamide, which potentiates the immune response, probably by inhibiting
regulatory T-cells, which, in turn, dampen the anti-tumor immune response.
Also, BCG is admixed with the vaccines because it functions as an immunological
adjuvant.
The
major endpoints of this study are the development of immunity to the patients
own NSCLC cells and a formal assessment of the safety of L-Vax. Patients will
be tested for DTH response to their own DNP-modified and unmodified NSCLC cells
prior to treatment and after the initial seven weekly vaccine injections.
Following completion of the post-vaccine DTH testing, patients will be offered
standard chemotherapy, which is now considered a standard of care, as an
adjuvant treatment. After chemotherapy, patients who remain well will be
eligible for a booster injection of L-Vax at the eight-month point. Adverse
events caused by the L-Vax vaccine will be measured and recorded, with DTH
results obtained at 2 ½ months and the maximum duration of the study for an
individual patient being 12 months.
We
anticipate that we will seek to enter into one or more alliances or strategic
partnerships with large pharmaceutical companies for the further development
and eventual commercialization of O-Vax or L-Vax.
Compassionate Use of
M-Vax
Beginning
in 2003 and continuing through the present, we have made M-Vax available on a
compassionate use basis in various European countries. We have recently made
M-Vax available on a compassionate use basis in various South American
countries. Compassionate use is considered for patients who have failed to
respond to accepted standards of care for their cancer and are facing a
prognosis of imminent death. Compassionate use of M-Vax has been permitted by
regulatory authorities in France, Spain, Greece, Venezuela and Belgium (even
though there is no approval for marketing of M-Vax in those countries) when the
patients prognosis is poor and there are no alternative treatments available.
Through December 31, 2007, we had 128 patients present for treatment on a
compassionate use basis, of which 60 patients were treated and 16 vaccines have
been produced and tested and are awaiting release to the clinical site. The
patients who were not treated were untreatable with the vaccine as a result of
inadequate cell count in the tumor sample received, the tumor samples received
were not melanoma, sterility issues with the tumor sample, or the death of the
patient prior to treatment being available. We expect to continue to treat
patients on a compassionate use basis outside the U.S. This development is
important to us and our AC Vaccine technology because it expands the
availability of the AC Vaccine within the scientific and medical communities
that are now seeking out the compassionate use of M-Vax. These experiences of
oncology leaders in various countries may become critical to the overall
scientific acceptance of the AC Vaccine technology in these countries. This
also will allow us to educate practitioners to maintain and aseptically handle
and ship tumors to reduce incidences where tumors become contaminated.
Additionally, although it is not the primary purpose of compassionate use of
our vaccine, we receive payments for the vaccine from the hospitals that
contract for the acquisition of the vaccine.
Contract Manufacturing
As
a result of our clinical activities in the U.S. and France, we have developed a
level of expertise related to the clinical production and regulation of cell
and gene therapy, and biological products. Cell and gene therapy, and
biological products research and development has been ongoing for a number of
years, but specific regulations of these products by most regulatory agencies
are just beginning to evolve. In February 2002 (effective April 2002), the
United States Pharmacopia published a chapter on manufacturing and testing
requirements relating to cell and gene therapies. Prior to the publication of
this chapter, there was no published guidance for companies engaged in the
production and testing of cell and gene therapies. Likewise, in Europe the
European Medicines Evaluation Agency is currently developing guidelines for the
production, testing and regulation of cell and gene therapy, and biological
products.
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Based
on our expertise, we have entered into various contract manufacturing
relationships in France. Contract manufacturing has been made possible by the
validation of our manufacturing facility first in France by AFSSAPs and
secondly through successful IND filings in the U.S. and in Europe. A contract
manufacturing engagement normally consists of two components. The first
component of the engagement is a feasibility study. The feasibility study
typically involves the transfer of production techniques from an unrelated
scientific laboratory to our facilities. After transferring the techniques, we
are engaged to develop the required procedures, tests and assays so that the
product can be produced in compliance with current Good Manufacturing Practices
requirements. After validating the procedures, tests and assays, we would then
contract to produce the necessary components for the manufacturing section to
be filed as part of an IND application.
Upon
acceptance of the IND by a regulatory agency, the second component of the
engagement would then commence. This component consists of the manufacturing
and testing of clinical samples for administration to patients as part of a
clinical trial. As part of this operation, we contract to maintain all the
necessary paperwork and documentation to demonstrate the work was done in
compliance with standards established by the applicable regulatory agency. In
addition, the documentation would be used to support further IND filings and
could be used as a component of a Biological License Application for approval
to market the product.
We
have entered into new agreements and intend to enter into future contract
manufacturing arrangements only to the extent the required work does not limit
or interfere with our own clinical development programs.
License and Research Agreements
The Thomas Jefferson
University License and Research Agreement
We
entered into a license agreement with Thomas Jefferson University for the AC
Vaccine technology in November 1995. The TJU license is a perpetual
royalty-bearing license for the rights to the AC Vaccine technology, and
provides for certain payments upon the occurrence of certain milestones. As
partial consideration, we paid $10,000 to TJU for the TJU license, $10,000 upon
initiation of the first clinical trial, and $25,000 upon our receipt of
approval from the FDA (or comparable international agency) to market products
relating to the AC Vaccine technology (which payment was triggered by our
receipt of that regulatory approval in Australia). We also issued to each of
TJU and Dr. Berd, 229,121 shares of our common stock, representing 7.5% (15% in
the aggregate) of our total outstanding voting securities at that time.
In
addition to the milestone payments we have already made to TJU, we are
obligated to pay TJU $10,000 upon the first filing of a marketing application
with the FDA (or comparable filing with a comparable international agency).
We
are presently obligated under the TJU license to spend a minimum of $500,000
per year on the development of the AC Vaccine technology until commercialized
in the U.S. If we file for FDA approval of a company-sponsored marketing
application for the right to market an AC Vaccine product, we may elect to
spend less than $500,000 per year on the development of the AC Vaccine
technology during the period of time the marketing application is under review
by the FDA.
In
connection with the TJU license, we also entered into a Clinical Study and
Research Agreement with TJU in 1995. Under the TJU license and the TJU research
agreement, we agreed to provide TJU with minimum sponsored research funding
relating to the development of additional immunotherapies based on the AC
Vaccine technology. We renewed this agreement for a three-year period through
November 2004. The research conducted by Dr. Berd and TJU under the TJU
research agreement pertained to applications of the AC Vaccine technology
beyond the core vaccine products we are developing.
In
2004, we reached an agreement with TJU to terminate the TJU research agreement
and all our obligations thereunder in exchange for a final payment by us to TJU
of $300,000, half of which we paid in 2004. In April 2005, we paid the balance
of $150,000 to TJU. We do not believe that the termination of the TJU research
agreement has had any meaningful effect upon us or our ability to continue our
AC Vaccine development efforts.
In
November 2004, Dr. Berd joined our staff as our Chief Medical Officer. Dr. Berd
continues to be instrumental to our regulatory and development efforts for the
AC Vaccine technology.
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We
are also obligated to pay TJU royalties on our net sales revenue and a
percentage of all revenues received from sublicenses relating to the AC Vaccine
technology. We bear the expense of maintaining and defending the patents that
are subject to the TJU license.
Research and Development Expense
Our
research and development activities focus primarily on clinical development and
trials of our AC Vaccine technology for the treatment of melanoma, ovarian
cancer, lung cancer and other cancers. Our clinical development program
includes the development of techniques, procedures and tests that need to be
developed as part of the manufacturing of our biological product so that the
product can be evaluated and potentially approved by regulatory authorities.
Our
research and development expenses consist primarily of costs associated with
the clinical trials of our product candidates, compensation and other expenses
for research personnel, payments to collaborators under contract research
agreements, costs for our consultants and compensation, materials, maintenance
and supplies for the operation and maintenance of our biological clean room
facilities, which are necessary for the production of materials to be used in
clinical trials. All of these costs qualify as research and development
expenses in accordance with the guidance included in Statement of Financial
Accounting Standards No. 2 Accounting for Research and Development Costs.
Manufacturing
costs included in this category relate to the costs of developing, supporting
and maintaining facilities and personnel that produce clinical samples in
compliance with current Good Manufacturing Practices. Our facilities and the
personnel maintained for manufacturing are currently at what we feel are the
minimum required for compliance with cGMP. Based upon the current capacity of
our facilities, our personnel and our current and future planned clinical
trials, we have excess capacity for the production and testing of biological
products. We use this excess capacity to generate cash in the form of contract
manufacturing alliances. Because the incremental costs incurred to provide these
services are not material or quantifiable, they are not presented separately.
Contract
manufacturing encompasses services we provide to other biotechnology or
pharmaceutical companies that are pursuing the clinical development of
biological products. The engagements generally consist of two components. The
first component is process validation in which the contracting company provides
information on its product and the processes and techniques used to produce the
product. Procedures are developed, documented and cataloged for the cGMP
production of the product using known and acceptable techniques, tests and
materials. Small scale lots are produced, and techniques, feasibility of the
production processes and tests validated. The end product of the first phase of
an engagement is a pilot batch of product and the necessary production
formulation and techniques to be used to file an IND with regulatory
authorities for human clinical trials. The second phase of an engagement
consists of the production of batches of product to be used in human clinical
trials. The typical engagement results in production of small batches of
product to be used in early stage (Phase I and II) clinical trials.
In
2006, we incurred research and development expense of $4,244,268 compared to
$3,534,948 in 2005, and $3,005,565 in 2004. For the first nine months of 2007,
our research and development expenses increased to $3,402,404 from $3,162,049
for the same nine months in 2006. Research and development expenses were
$51,054,172 for the period from inception through September 30, 2007. The
majority of these costs relate to clinical research and development of the AC
Vaccine technology. Our management estimates that greater than 90% of the
periodic and cumulative research and development expenses incurred relate to
our one major program, the AC Vaccine. At this time, due to the risks inherent
in the clinical trial process, risks associated with the product and product
characterization and risks associated with regulatory review and approval of
clinical product candidates, we are unable to estimate with any certainty the
costs we will incur in the continued development of our product candidates for
commercialization.
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Intellectual Property and Other Technology
Protections
Our
success will depend in large part on our ability to:
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Maintain and
obtain patent and other proprietary protection for products, processes and
uses of our products;
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Defend patents;
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Preserve
trade secrets; and
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Operate
without infringing the patents and proprietary rights of third parties.
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We
intend to seek appropriate patent protection for our proprietary technologies
by filing patent applications when possible in the U.S. and selected other
countries. In November 1995, we entered into an exclusive, worldwide license
agreement with Thomas Jefferson University for all of its patents and pending
patent applications relating to the AC Vaccine. Currently, five U.S. patents
have been issued, all of which are subject to the TJU license. In addition, one
European patent (EP1162996) has been granted and validated in France, Germany,
Spain and the United Kingdom, and one European patent has been allowed by the
European Patent Office (pending grant), both of which are subject to the TJU
license. Also, three Australian patents (AU727316, AU757980 and AU785031) have
been issued that are subject to this license. Several patent applications are
currently pending in the U.S. and other jurisdictions. The following table
summarizes the issued U.S. patents relating to the AC Vaccine:
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Patent No.
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Patent
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Date Issued
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Date Expires
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6,248,585
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Composition
for preserving haptenized tumor cells for uses in vaccines
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June 19, 2001
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November 16, 2019
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6,333,028
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Methods of
using haptenized ovarian carcinoma tumor cells
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December 25, 2001
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July 24, 2017
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6,403,104
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Hapten-conjugated
mammalian cells and methods of making and using thereof
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June 11, 2002
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March 16, 2020
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6,458,369
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Composition
comprising tumor cells and extracts and method of using thereof
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October 1, 2002
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May 4, 2019
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U.S.
Patent No. 5,290,551, Treatment of Melanoma with a Vaccine comprising
Irradiated Autologous Melanoma Tumor Cells Conjugated to a Hapten, was
originally issued on March 1, 1994, and was placed in reissue. The reissue
application was subsequently abandoned.
These
patents cover methods of making the vaccine, composition of matter, as well as
therapeutic use. We intend to continue using our scientific expertise to pursue
and file patent applications on new developments with respect to processes,
methods and compositions to enhance our intellectual property position in the
field of cancer treatment.
Any
patents or patent rights that we obtain may be circumvented, challenged or
invalidated by our competitors. In addition, others may challenge that our
products and processes specifically infringe their patents. On
September 17, 1999, a complaint was filed against us in the U.S. District
Court for the District of Maryland by Intracel Corporation. Intracel sought
monetary damages and an injunction against the use of our autologous cell
vaccine technologies. Intracel claimed that our technologies infringed their U.S.
patent entitled Active Specific Immunotherapy. Intracel later withdrew their
case.
We
also rely on trade secrets and proprietary know-how related to the production
and testing of our products, especially when we do not believe that patent protection
is appropriate or can be obtained. Our policy is to require each of our
employees, consultants and advisors to execute a confidentiality and inventions
agreement prohibiting the disclosure of our confidential information before
they begin a relationship with us.
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Manufacturing and Marketing
AC
Vaccines - General
Our
AC Vaccine products under development are individualized therapies that are
manufactured by first receiving tumors from a patient, treating those tumors to
break them down to the basic cancer cell and creating a liquid vaccine using
the cells as a raw material, then delivering the vaccine to the doctors office
for administration to the patient. We believe that the key to success in
developing and distributing individualized therapies relies upon a model
employing central processing, so that manufacturing cell based products can be
a standardized process that can benefit from economies of scale and efficient
distribution. The basic model for the vaccine is cells in-product out, where
the final product looks like a traditional mass-produced drug to the end-user,
but is manufactured individually. We are not currently treating patients in the
U.S. or Europe, other than on a compassionate use basis in certain European
countries, because the AC Vaccine products have not yet been approved for
treatment.
We
are in the process of revalidating our Philadelphia facility with the FDA for
the purpose or re-establishing that facility as a current Good Manufacturing
Practices facility in which our vaccines and other biologics can be produced.
We anticipate completing this process by spring 2008.
Manufacturing
the AC Vaccine
Based
upon re-engineering the manufacture of the vaccine technology, we no longer
require regional manufacturing capabilities. We made a strategic decision in
early 2003 to use our facility in Lyon, France as our primary facility for the
production of our cell based therapies. The Lyon facility has been inspected by
AFSSAPs (the French equivalent of the U.S. FDA) and has received the
designation of Etablissement Pharmaceutique and more recently has obtained
the designation Etablissement Thérapies Gèniques et Cellulaires. The Etablissement
Pharmaceutique designation is required for the production of any commercial
product to be sold in France and throughout Europe. The Etablissement Therapies
Geniques et Cellulaires designation is required in France for the commercial
production of cell and gene therapy products.
Other
Foreign Markets for M-Vax
During
2002, we entered into a distribution agreement with Ferrer Internacional, S.A.
for the sales and marketing of the vaccine in certain territories in Europe,
Latin America and Asia. With the assistance of Ferrer, we are investigating
potential market opportunities to begin initiating sales of M-Vax in certain
countries in Europe. The commercialization of M-Vax in one or more European
countries will be subject to meeting certain requirements determined by each
applicable regulatory agency.
Sources and Availability of Raw Materials
We
do not expect to encounter significant difficulties in obtaining raw materials
for M-Vax, O-Vax, L-Vax or any of our other AC Vaccine products, because they
consist primarily of a readily available chemical reagents and the patients
own tumor cells. We administer the AC Vaccine with BCG. BCG is an approved
product for other cancer indications and is being administered by other
companies as a separate vaccine. There are several sources of BCG, each
formulation of which differs based upon the original source of the product. If
we are unable to continue to obtain the current strain of BCG used in our
clinical trials, we may not be permitted by regulatory authorities to use
another strain of BCG without conducting additional clinical studies with the
new strain of BCG.
For
our Phase III registration trial for M-Vax, the six weekly doses of M-Vax
administered with BCG will be followed by the patients receiving a course of
low dose IL-2 administered subcutaneously. IL-2 is produced exclusively by
Novartis AG. While IL-2 is not a raw material used in our vaccines, it is an
important part of our current Phase III registration trial.
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Competition
We face
substantial competition in the development of our products. Competition comes
from other companies that are developing the same type of products as ours, as
well as other companies that are developing different types of products that
are designed for the same uses as our products. Competition also comes in the
form of new product types or extension of existing product types that are being
continuously researched and developed by scientists, government contractors and
other companies. We expect that this competition will continue in
both the U.S. and international markets.
Cancer
immunotherapies continue to evolve rapidly with new scientific breakthroughs
that are expected to continue in the coming years with the evolution of new
techniques and equipment. We are aware of a number of groups that are currently
developing cancer immunotherapies that include academic institutions,
government agencies and research institutions, early stage and developed
bio-technology companies and pharmaceutical companies. For example, MEDAREX, in
partnership with Bristol-Myers Squibb, launched two Phase III programs for the
treatment of late stage melanoma patients with immunotherapy products. IDM
Pharma has an ongoing Phase II clinical trial for a cell based therapeutic for
the treatment of melanoma. Other companies that are developing immontherapies
for the treatment of cancer include Dendreon Corporation, Opexa Therapeutics,
Therion Biologics Corporation, Onyvax Ltd., Antigenics, Genitope Corporation,
Cell Genesys Corporation, Biomira, Inc and Favrille, Inc. Vical Incorporated
and Genta Incorporated both indicate that they have Phase III programs underway
for melanoma. At the National Institute of Healths website, clinicaltrials.gov,
there are 244 clinical studies listed for the treatment of melanoma.
The
Competition we face from these companies is in the areas of clinical trial site
and patient recruitment, in establishing alliances with academic institutions
and thought leaders, recruiting and retaining employees, hiring contractors to
provide services in the execution of clinical studies and in establishing
relationships with large bio-tech or pharmaceutical partners for joint
development and collaboration relationships. Negative clinical studies by other
immunotherapy companies as well as failures in later stage clinical trials in
our key indications could also have a negative effect on our development
efforts, the acceptance of our development plans or the future
commercialization of our products.
Government Regulation
The
research, pre-clinical development, clinical trials, product manufacturing and
marketing conducted by us or on our behalf are subject to regulation by the FDA
in the U.S., AFSSAPs (the French equivalent of the U.S. FDA) in France, and
similar health authorities in other foreign countries, as well as the European
Medical Evaluations Agency (EMEA) which has broad oversight over most
European Member States. Our proposed products and technologies also may be
subject to certain other international, U. S. federal, state and local
government regulations, including, the Federal Food, Drug and Cosmetic Act,
Public Health Service Act, and their state, local and foreign counterparts.
Generally,
the steps required before a pharmaceutical or therapeutic biological agent may
be marketed in the U.S. include: (i) pre-clinical laboratory tests,
pre-clinical studies in animals, toxicity studies and formulation studies; (ii)
the submission to the FDA of an IND for human clinical testing, that must
become effective before human clinical trials commence; (iii) adequate and
well-controlled human clinical trials to establish the safety and efficacy of
the drug; (iv) the submission of a marketing application to the FDA; (v)
approval of the manufacturing processes and controls; and (vi) FDA approval of
the marketing application prior to any commercial sale or shipment of the drug.
Pre-clinical
studies include laboratory evaluation of the product, mostly conducted under
Good Laboratory Practice regulations, and animal studies to assess the
pharmacological activity and the potential safety and effectiveness of the
drug. The results of the pre-clinical studies are submitted to the FDA in the
IND. Unless the FDA objects to an IND, it becomes effective 30 days following
submission and the clinical trial described in the IND may then begin.
Clinical
trials begin when a drug is approved for testing on humans. There are usually
said to be three main phases of clinical trials that a drug must go through in
the U.S. before the drug is approved to be manufactured and marketed to the
public. These phases may involve testing of drugs in healthy human volunteers
(Phase I) for assessment of safety, followed by tests of effectiveness and
safety in patients with illnesses the drug is designed to treat (Phases II and
III). In most instances, Phase III studies are the final group of studies that
are conducted before a product can be approved by the FDA for commercial use.
In the case of life-threatening illness, the study process and phases of
clinical trials may be compressed and accelerated. In some cases, Phase II
trials are deemed sufficient for market approval by the FDA or foreign
regulatory authorities. Pivotal registration trials are large-scale Phase II or
III trials, the data obtained from which are intended to be used to provide for
the registration of a drug or product for market use.
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Every
clinical trial must be conducted under the review and oversight of an
institutional review board at each institution participating in the trial. The
institutional review board evaluates, among other things, ethical factors, the
safety of human subjects, and the possible liability of the institution. In
addition, when a sponsor has more than one clinical site participating in a
study, they typically establish a Data Safety Monitoring Board that has
oversight responsibilities for the safe conduct of the clinical studies.
The
results of the pre-clinical and clinical trials are submitted to the FDA as
part of an application to market the drug. The marketing application also
includes information pertaining to the chemistry, formulation and manufacture
of the drug and each component of the final product. The FDA review of a
marketing application takes from one to two years on average to complete,
though reviews of treatments for cancer and other life-threatening diseases may
be accelerated. The process may take substantially longer, however, if the FDA
has questions or concerns about a product. Following review, the FDA may ultimately
decide that an application does not satisfy regulatory and statutory criteria
for approval or that further information and testing is required. In some
cases, the FDA may approve a product but require additional clinical tests
following approval that are referred to as post marketing studies (i.e., Phase
IV).
In
addition to obtaining FDA approval for each product, each domestic drug
manufacturing facility must be registered with, and approved by the FDA.
Domestic manufacturing facilities are subject to inspections by the FDA and
must comply with current Good Manufacturing Practices. To supply products for
use in the U.S., foreign manufacturing facilities also must comply with current
Good Manufacturing Practices, and are subject to periodic inspection by the FDA
or by comparable foreign regulatory agencies under reciprocal agreements with
the FDA.
If
marketing approval of any of our products is granted, we must continue to
comply with FDA requirements not only for manufacturing, but also for labeling,
advertising, record keeping, and reporting to the FDA of adverse experiences
and other information. In addition, we must comply with federal and state
health care anti-kickback laws and other health care fraud and abuse laws that
affect the marketing of pharmaceuticals. Failure to comply with applicable laws
and regulations could subject us to administrative or judicial enforcement
actions, including product seizures, injunctions, civil penalties, criminal
prosecution, refusals to approve new products or withdrawal of existing
approvals, as well as increased product liability exposure.
The
regulatory approval process for new drugs in France is substantially similar to
the process described above for the U.S. Generally, the steps required before a
pharmaceutical or therapeutic biological agent may be marketed in France
include (i) pre-clinical laboratory tests, pre-clinical studies in animals,
toxicity studies and formulation studies; (ii) the submission to AFSSAPs of an
IND for human clinical testing, that must be approved before human clinical
trials commence; (iii) adequate and well-controlled human clinical trials to
establish the safety and efficacy of the drug; (iv) the submission of a
marketing application to AFSSAPs; (v) approval of the manufacturing processes
and controls; and (vi) AFSSAPs approval of the marketing application prior to
any commercial sale or shipment of the drug.
The
primary difference between the U.S. and French regulatory processes is the
evolution of the thinking of each regulatory agency to the application of the
procedures described above, which were designed for traditional, mass-produced
prescription drugs and similar procedures, to the regulation of autologous
products, meaning those products, such as the AC Vaccine, whose origin is
primarily from the patient with minimal manipulation.
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In
2002, AFSSAPs published the first regulations specific to the regulation of
cell and gene therapies that are produced on an individual patient basis, which
includes the AC Vaccine technology. These regulations differentiate these
products from standard pharmaceutical products. We interpret that these
regulations will evaluate cell and gene therapy products by the level and type
of manipulation to the product. We believe that certain cellular products,
including M-Vax, will be regulated differently from standard drugs. For these
technologies, marketing approval will be authorized upon the satisfaction of
two criteria. One of the requirements will be that the therapeutic is
manufactured in a cGMP-compliant facility and manner. Secondly, the therapeutic
will need to be able to demonstrate a reasonable claim for efficacy.
Using
the data generated in the studies conducted at Thomas Jefferson University as
the basis for the efficacy claims of M-Vax, we submitted the equivalent of a
Biologics License Application to the French authorities in March 2005 under
their Cell and Gene Therapy Regulations. In preparing the submission, we
utilized the format for the Common Technical Document (CTD) provided by the
International Conference of Harmonization and adopted by the U.S., Europe and
Japan. The purpose of the CTD is to harmonize the filing requirements for
biologic products in the various regions. We received acknowledgement from
AFSSAPs of receipt of our submission effective March 23, 2005. In February
2006, we received notification from AFSSAPs that additional clinical data will
be necessary for approval of the product under these regulations. We are
meeting with the agency to discuss the additional requirements, potential
planned studies to obtain the information and to discuss our ability to make
the vaccine available on a compassionate use basis while this data is being
accumulated.
For
clinical investigation and marketing outside the U.S. and France, we also are
subject to certain foreign regulatory requirements governing human clinical
trials and marketing approval for drugs. The requirements governing the conduct
of clinical trials, product licensing, pricing and reimbursement vary widely
for European countries both within and outside the European Union (EU).
Normally, foreign marketing authorizations are applied for at a national level,
although within the EU certain registration procedures are available to
companies wishing to market their products in more than one EU member state. If
any applicable regulatory authority is satisfied that adequate evidence of
safety, quality and efficacy has been presented, a marketing authorization will
be granted. The system for obtaining marketing authorizations within the EU
registration system is a dual one in which certain products, such as
biotechnology and high technology products and those containing new active
substances, will have access to a central regulatory system that provides
registration throughout the entire EU. Other products will be registered by
national authorities in individual EU member states, operating on a principle
of mutual recognition.
Employees
As
of September 30, 2007, we had 29 employees, consisting of 23 full-time
employees at our subsidiary in France and 6 full-time employees in the U.S.
Description of
Property
We
lease a pharmaceutical and gene therapy clinical manufacturing facility in
Lyon, France. The facility consists of approximately 9,000 square feet, of
which approximately 7,000 square feet are utilized for manufacturing
development, including 3,000 square feet of clean rooms and 2,000 square feet
for office space. Currently, the monthly rental on the facility is
approximately $14,800. The lease is for a 9-year period through 2009 and is
extendable for another 9-year period.
We
lease a facility in Philadelphia, Pennsylvania, which is used for our executive
offices and is suitable for our clinical manufacturing activities. The facility
consists of approximately 11,900 square feet, of which approximately 9,300
square feet are suitable for manufacturing development, while the remaining
2,600 square feet are used for office space. We have options for additional
space. Currently, the monthly rental on the facility is approximately $16,625.
The lease was recently extended for a 5-year period through January 2013 and is
extendable for one additional five-year period.
We
believe that each of these properties is adequately covered by insurance.
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Table of Contents
Legal Proceedings
In
May 2007, we completed a private placement of securities to various
institutional and accredited investors. The Company had previously entered into
an engagement letter, as subsequently amended, with MDB Capital Group LLC in
connection with the proposed capital raising engagement. MDB Capital has made a
demand that we pay MDB Capital $195,000 in cash and issue MDB Capital warrants
to purchase 2,080,000 shares of common stock of the company at an exercise
price of $0.15 per share, all as compensation to MDB Capital under the
engagement letter. We have conceded that we owe MDB Capital $15,000 in
placement agent fees and a placement agent warrant to purchase 160,000 shares
of common stock of the company at $0.15 per share under the engagement letter.
We believe that MDB Capital had no role in identifying the other investors in
the offering for which MDB Capital claims compensation, and thus have denied
that we owe MDB Capital any additional cash compensation or placement agent
warrants under the engagement letter. MDB Capital has indicated its intention
to pursue binding arbitration of this dispute in accordance with the terms of
the engagement letter, but has to date made no effort to pursue any arbitration
of this matter.
We
are periodically involved in ordinary, routine litigation and administrative
proceedings incidental to our business. As of the date of this report, there
are no other pending or, to our knowledge, threatened material claims against
us.
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Table of Contents
M
ANAGEMENT
Directors and
Executive Officers
Our
executive officers and directors, as well as certain information about them,
are as follows:
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Name
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Age
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Position with the Company
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John K. A.
Prendergast, Ph.D.
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52
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Chairman of
the Board and Director
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Francois R.
Martelet, MD
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47
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Chief
Executive Officer, President and Director
|
|
|
|
|
|
Richard P.
Rainey
|
|
41
|
|
Principal
Accounting Officer
|
|
|
|
|
|
David Berd,
M.D.
|
|
63
|
|
Chief
Medical Officer
|
|
|
|
|
|
Edson D. de
Castro
|
|
68
|
|
Director
|
|
|
|
|
|
Andrew W.
Dahl, Sc.D.
|
|
63
|
|
Director
|
|
|
|
|
|
Carl Spana,
Ph.D.
|
|
43
|
|
Director
|
John K. A. Prendergast, Ph.D.,
has been a
director of the company since July 1996. Dr. Prendergast has served as
President and principal of Summercloud Bay, Inc., a biotechnology-consulting
firm, since 1993. He is a co-founder or member of the board of
directors of Avigen, Inc. and Palatin
Technologies, Inc. From October 1991 through December 1996, Dr. Prendergast was
a Managing Director of The Castle Group Ltd. Dr. Prendergast received his M.Sc.
and Ph.D. from the University of New South Wales, Sydney, Australia and a
C.S.S. in Administration and Management from Harvard University. In November
2003, Dr. Prendergast was named Chairman of the Board of the company.
Francois R. Martelet, MD.,
was
elected to the board of directors of the company, effective July 20, 2007, and
was appointed as Chief Executive Officer and President of the company as of December
1, 2007. Dr. Martelet served as Vice-President and Global Franchise Head,
Oncology at Merck & Co. from July 2005 through December 2006. From July
2003 through July 2005, Dr. Martelet was the Regional Pharma Head, Central
& Eastern Europe, Middle East and Africa for Novartis Pharma, AG. Prior to
that, Dr. Martelet served in various other senior officer positions within
various units of Novartis Pharmaceutical, including leading the Oncology
Business Units in Asia, Latin America, Central and Eastern Europe, the Middle
East and Africa. Prior to joining Novartis, Dr. Martelet served in various
oncology-related capacities with Schering-Plough International, Eli Lilly
Corporation and F. Hoffman-la Roche, AG. Dr. Martelet is presently providing
consulting services to clients in the life sciences and biotechnology industry.
Dr. Martelet received a Doctorate in Medicine with distinction and a
Pharmaceutical Marketing Masters Degree in Business from Dijon University,
France. He also holds a degree in Legal Medicine from R. Descartes University
School of Medicine, Paris.
Richard P. Rainey, C.P.A.,
is currently the
Principal Accounting Officer of the company. Mr. Rainey recently entered into a
new employment agreement with the company, effective as of December 31, 2007, under which he agreed
to remain with the company as our Principal Accounting Officer until May 31,
2008. We do not anticipate that Mr. Rainey will continue in his current
position with the company beyond May 31, 2008. Since joining the company in September 1998, Mr. Rainey has served in
various positions, including Chief Executive Officer, President, and Chief
Financial Officer until December 1, 2007, when he became Principal Accounting
Officer. Mr. Rainey has also served as Vice President for Finance and
Administration and Controller and as a director of the company from May 2007
until January 23, 2008. Prior to joining the company, Mr. Rainey was a partner
with Rainey & Rainey, a certified public accounting firm that he founded in
1993. During that period, Rainey & Rainey provided accounting and
consulting services to corporations with an emphasis in health care. From 1988
to 1993, Mr. Rainey was an associate with Ernst & Young, LLP specializing
in auditing and consulting. Mr. Rainey received his B.S. in Accounting from
Pennsylvania State University in 1988.
37
Table of Contents
David Berd, M.D.,
joined the company as
Chief Medical Officer in November 2004. He has been Professor of Medicine at
Thomas Jefferson University since 1984. Dr. Berd is the inventor of the AC
Vaccine technology, and conducted all the clinical trials of the vaccine
completed to date. He is the author of numerous published papers on the basic
science and clinical testing of the vaccine. Dr. Berd is a board-certified
medical oncologist, and received training at the University of Pennsylvania and
Yale University School of Medicine.
Edson D. de Castro
has been a director of
the company since October 1993. Since 1990, Mr. de Castro has been consulting
for companies and participating as a member of certain Boards of Directors. Mr.
de Castro was one of five co-founders of Data General Corporation in 1968 for
which, from 1968 to 1989, he served as its President and Chief Executive
Officer, and from 1989 to 1990, he served as its Chairman of the board
of directors. From 1995 to 1997, Mr. de
Castro was the Chief Executive Officer and Chairman of the board of
directors of Xenometrix, Inc. Mr. de Castro
was a founder and Executive Committee Member of the Massachusetts High Tech
Council. Mr. de Castro is a Trustee of Boston University. Mr. de Castro
received his B.S. in Electrical Engineering from the University of Lowell in
1960.
Andrew W. Dahl, Sc.D.,
has been a director
of the company since September 1999. Since May 2007, Dr. Dahl has served as
Chief Innovation Officer of Fairview Health Services, a $2.5 Billion nonprofit
health organization, that is a clinical arm of the University of Minnesota.
From March 2005 to March 2007, Dr. Dahl served as the Vice President of
Consumer Driven Health and Human Resources of Alegent Health, a nonprofit,
multi-hospital and health system headquartered in Omaha, Nebraska. He served as
President and CEO of Evolution Benefits, a Division of Evolution Health, LLC.,
from July 2000 through February 2005. From July 1994 through December 1999, Dr.
Dahl served as the President and Chief Executive Officer of HealthNet, Inc.
From July 1990 through March 1994, Dr. Dahl served as President and Chief
Executive Officer of IVF America, Inc. (now known as IntegraMed America), where
he was instrumental in taking the corporation public. Dr. Dahl also served as
Executive Vice President and Chief Operating Officer of St. John Health and
Hospital Corporation in Detroit, a university-affiliated medical center, and
was Vice President for Development of the Hospital Corporation of America,
Management Company. Dr. Dahl received his Sc.D. from The Johns Hopkins
University and a M.P.A. from Cornell University. Dr. Dahl is also a fellow in
the American College of Health Care Executives.
Carl Spana, Ph.D.
, has been a director of
the company since September 1995 and was our Interim President from August 1995
to June 15, 1996. Dr. Spana is a co-founder of Palatin Technologies, Inc. and
has been its president and chief executive officer since June 2000. He has been
a director of Palatin since June 1996 and has been a director of RhoMed
Incorporated since July 1995. Dr. Spana has served Palatin in other executive
capacities prior to June 2000. Dr. Spana was vice president of Paramount
Capital Investments, LLC, a biotechnology and biopharmaceutical merchant
banking firm, and of The Castle Group Ltd., a medical venture capital firm.
Through his work at Paramount Capital Investments and Castle Group, Dr. Spana
co-founded and acquired several private biotechnology firms. From July 1991 to
June 1993, Dr. Spana was a Research Associate at Bristol-Myers Squibb, where he
was involved in scientific research in the field of immunology. Dr. Spana
received his Ph.D. in molecular biology from The Johns Hopkins University and
his B.S. in biochemistry from Rutgers University.
Audit Committee, Financial Expert,
Compensation Committee and Code of Ethics
Our Audit
Committee consists of our independent directors, Dr. Dahl, Mr. de Castro and
Dr. Spana. Our board of directors has determined that Mr. de
Castro and Dr. Spana qualify as audit committee financial experts, as defined
by the rules of the Securities and Exchange Commission. Mr. de Castro and Dr.
Spana, Dr. Dahl are independent within the meaning of Nasdaq Rule 4200(a)(15), which is the independence test utilized by the
Board even though our common stock is no longer listed on Nasdaq.
Our
Compensation Committee consists of Mr. de Castro, Dr. Dahl and Dr. Spana.
We
adopted a Code of Ethics at a meeting of the board of directors held on
June 14, 2005, which applies to our principal executive officer and
principal financial officer.
38
Table of Contents
Executive
Compensation
The
following Summary Compensation Table sets forth the compensation earned by the
persons serving as our chairman of the board, chief executive officer and the
other named key employees (who were the only other employees who made in excess
of $100,000 in 2007) (the Named Officers) for the last three fiscal years. We
have no long-term incentive plans.
Our
Chairman of the Board, Dr. John Prendergast, is not an employee of the company.
He has served as an independent director of the company since 1996. Due to our
reduction in the executive staff in 2002, Dr. Prendergast, at the request of
the board of directors, has assisted management in certain strategic
initiatives and related matters since that time. The board of directors
continues to view Dr. Prendergast as an independent director, but his
compensation has significantly exceeded the customary fees for outside
directors due to the services provided by Dr. Prendergast at the request of the
Board. All extraordinary consulting fees paid to Dr. Prendergast have been
approved by the other independent members of the Board. Effective December 1,
2003, the Board approved monthly compensation to Dr. Prendergast of $10,500,
plus reimbursement of out-of-pocket expenses for consulting services provided
by Dr. Prendergast to us, which will consist of not less than five days of
service per calendar month.
Summary Compensation Table
Annual Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name and
Principal
Position
|
|
Year
|
|
Salary
($)
|
|
Bonus
($)
|
|
Option
Awards
($)
|
|
All Other
Compensation
($)
|
|
Total
Compensation
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John K.A. Prendergast, Ph.D.
|
|
|
2007
|
|
$
|
|
|
$
|
|
|
$
|
22,071
|
|
$
|
126,000
|
|
$
|
148,071
|
|
Chairman of
the Board
1
|
|
|
2006
|
|
|
|
|
|
|
|
|
20,556
|
|
|
126,000
|
|
|
146,556
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Francois R. Martelet, M.D. President, CEO, Director
2
|
|
|
2007
|
|
|
37,500
|
|
|
|
|
|
7,427
|
|
|
5,000
|
|
|
49,927
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard P.
Rainey, C.P.A. Principal
|
|
|
2007
|
|
|
320,750
|
|
|
|
|
|
54,235
|
|
|
|
|
|
374,985
|
|
Accounting
Officer
3
|
|
|
2006
|
|
|
275,000
|
|
|
|
|
|
31,872
|
|
|
|
|
|
306,872
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Berd,
M.D.
|
|
|
2007
|
|
|
231,333
|
|
|
|
|
|
23,275
|
|
|
|
|
|
254,608
|
|
Chief
Medical Officer
4
|
|
|
2006
|
|
|
220,000
|
|
|
|
|
|
18,000
|
|
|
|
|
|
238,000
|
|
|
|
|
1
|
The other compensation
shown for Dr. Prendergast consisted of $126,000 of additional compensation
paid for the services rendered by Dr. Prendergast as a non-employee director
of the Company for each of the years 2006 and 2007.
|
2
|
Option Awards includes the
value of the 300,000 options granted to Dr. Martelet upon his appointment as
director of the company, prior to his appointment as President and Chief
Executive Officer. Dr. Martelets Other Compensation consists of the director
fees he received for his service as director prior to his appointment as
President and Chief Executive Officer. Dr. Martelets employment agreement
provides for a base salary of $450,000 per year.
|
3
|
Amount shown does not
include a $350,000 bonus paid to Mr. Rainey on January 23, 2008 for prior
services in conjunction with his execution of a new employment agreement
described below. Mr. Raineys current employment agreement provides for a
base salary of $275,000 per year.
|
4
|
Dr. Berds employment
commenced November 1, 2004, and his agreement provides for a minimum annual
base salary of $180,000.
|
39
Table of Contents
Outstanding Equity Awards at Fiscal Year-End
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Awards
|
|
|
|
|
|
Name and Principal
Position
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
|
Option
Exercise
Price
($)
|
|
Option
Expiration
Date
|
|
|
|
|
|
|
|
|
|
|
|
Francois R. Martelet, M.D.
|
|
|
|
|
|
7,130,288
|
|
|
0.09
|
|
|
12/01/14
1
|
|
CEO, President and Director
|
|
|
75,000
|
|
|
225,000
|
|
|
0.18
|
|
|
7/20/17
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard P. Rainey, C.P.A.
|
|
|
50,000
|
|
|
|
|
|
0.906
|
|
|
3/26/08
3
|
|
President and Corporate Secretary
|
|
|
130,000
|
|
|
|
|
|
0.890
|
|
|
11/02/08
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
218,750
|
|
|
31,250
|
|
|
0.125
|
|
|
10/01/11
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
343,750
|
|
|
156,250
|
|
|
0.300
|
|
|
6/07/12
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
250,000
|
|
|
750,000
|
|
|
0.190
|
|
|
8/27/14
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. David
Berd Chief
|
|
|
162,500
|
|
|
37,500
|
|
|
0.150
|
|
|
11/01/11
3
|
|
Medical
Officer
|
|
|
171,875
|
|
|
78,125
|
|
|
0.300
|
|
|
6/07/12
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187,500
|
|
|
562,500
|
|
|
0.190
|
|
|
8/27/14
3
|
|
|
|
|
1
|
Options expire seven years from the date of grant and vest yearly over a four-year period
of continuing service as an employee, commencing December 1, 2008.
|
2
|
Options expire ten years from the date of grant and vest yearly over a four-year period
of continuing service as an employee.
|
3
|
Options expire seven years from the date of grant and vest quarterly over a four-year
period of continuing service as an employee.
|
40
Table of Contents
Compensation of Directors
Director Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name and
Principal Position
|
|
Fees earned
or paid in
cash
($)
|
|
Option
Awards
($)
|
|
All Other
Compensation
($)
|
|
Total Compensation
($)
|
|
|
|
|
|
|
|
|
|
|
|
John K.A.
Prendergast, Ph.D. Chairman of the Board
1
|
|
$
|
|
|
$
|
22,071
|
|
$
|
126,000
|
|
$
|
163,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Francois R.
Martelet, M.D. CEO, President and Board of Directors
2
|
|
|
5,000
|
|
|
|
|
|
|
|
|
5,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carl Spana,
Ph.D. Board of Directors
3
|
|
|
16,750
|
|
|
6,102
|
|
|
|
|
|
46,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andy Dahl,
Sc. D Board of Directors
4
|
|
|
16,000
|
|
|
3,354
|
|
|
|
|
|
46,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Edson
deCastro Board of Directors
5
|
|
|
16,000
|
|
|
3,354
|
|
|
|
|
|
46,000
|
|
|
|
|
(1)
|
As of December 31, 2007,
Dr. Prendergast had 593,101 option awards outstanding.
|
(2)
|
Amounts shown reflect Dr.
Martelets compensation prior to his appointment as CEO and President. As of
December 31, 2007, Dr. Martelet had 7,430,288 option awards outstanding.
|
(3)
|
As
of December 31, 2007, Dr. Spana had 160,000 option awards outstanding.
|
(4)
|
As of December 31, 2007,
Dr. Dahl had 110,000 option awards outstanding.
|
(5)
|
As
of December 31, 2007, Mr. deCastro had 110,000 option awards outstanding.
|
In
2007, we had two in-person Board meetings, one in-person committee meeting, and
thirteen telephonic Board or committee meetings.
Effective
January 1, 2006, the Compensation Committee of the Board of Directors approved
the following cash compensation for non-employee directors, which compensation
will not be paid to Dr. Prendergast for so long as he is separately compensated
for the additional services he is providing to the company as our Chairman of
the Board:
Non-Employee Director Compensation
|
|
|
|
|
Cash Compensation
|
|
|
|
|
|
|
|
In-Person
Board Meeting
|
|
$5,000
|
|
Telephonic
Board Meeting
|
|
750 per hour up to a maximum of 2,000
|
|
In-Person
Committee Meeting
|
|
1,000
|
|
Telephonic
Committee Meeting
|
|
750
|
|
Audit
Committee Chairman
|
|
6,000 per year
|
|
Compensation
Committee Chairman
|
|
3,000 per year
|
In
conjunction with the addition of Dr. Martelet to the Board of Directors, he was
issued options to purchase 300,000 shares of common stock. At that time, the
other members of the Board of Directors determined that options to purchase
300,000 shares of common stock was a fair annual grant to the other independent
members of the Board, as described above.
41
Table of Contents
See
Executive Compensation above for a description of certain compensation paid
to Dr. Prendergast 2006 and 2007 and stock options awarded to Dr. Prendergast
for additional services provided by Dr. Prendergast to us, at the request of
our board of directors.
Employment Agreements
Dr. Francois R. Martelet.
Pursuant to the
terms of Dr. Martelets employment agreement, as amended, he will serve as our
President and Chief Executive Officer for a term commencing December 1, 2007,
and ending on December 1, 2010. If Dr. Martelets employment is terminated for
any reason, he will also be required to resign from his current position as
member of the Board of Directors.
The
terms of the employment agreement provide that Dr. Martelet will receive an
annual base salary of $450,000, subject to yearly review for increase.
Additionally, Dr. Martelet is entitled to participate in our annual
discretionary bonus program. Under the discretionary bonus program, Dr.
Martelet is eligible to receive up to 50% of his then current base salary based
on milestones to be mutually agreed on between the Compensation Committee and
Dr. Martelet. Dr. Martelet is guaranteed a minimum bonus of 30% of the base
salary for his first year of employment. Dr. Martelet is also eligible for cash
performance bonuses upon attainment of certain pre-determined milestones based
on market capitalization met within the first 42 months of employment.
In
conjunction with Dr. Martelets initial employment, the Board of Directors
awarded Dr. Martelet options to purchase common stock in an amount equal to 5%
of the outstanding shares of common stock of the company (Equity Grant A).
Dr. Martelet was awarded options to purchase 1,000,000 shares of common stock
under the companys 2006 Equity Incentive Plan and inducement stock options to
purchase 6,130,288 shares of common stock outside of the 2006 Equity Incentive
Plan. The options vest in four equal annual installments on each of the first
four anniversaries of the effective date of the employment agreement, have an
option exercise price per share of $0.09, and expire on December 1, 2014.
If
at any time prior to December 1, 2008, our valuation reaches or exceeds
$75,000,000 (as calculated in accordance with the employment agreement) for a
period of 30 consecutive days, we will grant to Dr. Martelet additional equity
grants pursuant to the equity plan then in effect (Equity Grant B). Equity
Grant B will be issued as a combination of stock options and restricted stock
units pursuant to the same terms and conditions as set forth above for the
initial stock option grant, except that options will be granted at the fair
market value of the common stock on the effective date of Equity Grant B. The
amount of shares comprising Equity Grant B will be determined using the
following formula; provided however, that if it the formula calculates Equity
Grant B to be equal to 0 or a negative number of shares, the number of shares
to be issued as Equity Grant B shall be determined by the compensation committee
of the Board: Equity Grant B = (0.035 x common outstanding shares) 7,130,288
options under Equity Grant A. For purposes of this formula, common outstanding
shares is defined as the number of shares of common stock outstanding as of the
date of determination plus the number of shares of common stock as to which any
shares of preferred stock are then convertible.
Dr.
Martelet is also entitled to additional stock options and restricted stock
grants at the sole discretion of the Board of Directors.
The
employment agreement provides for the accelerated vesting of the options (both
Equity Grant A and Equity Grant B) if there is a change in control of the
company or he is terminated for certain reasons specified in the employment
agreement.
Pursuant
to the employment agreement, Dr. Martelets employment will terminate upon the
occurrence of any of the following: (i) the expiration of the employment
period, unless the company and Dr. Martelet agree to extend the term or otherwise
continue Dr. Martelets employment on mutually agreeable terms, (ii) at the
election of the company for cause, immediately upon written notice by the
company to Dr. Martelet, which notice of termination will have been approved by
a majority of the Board, (iii) immediately upon death or disability, (iv) at
the election of Dr. Martelet, for good reason, immediately upon written notice
of not less than 60 days, (v) at our election, upon or within 12 months
following a change in control, or at the election of Dr. Martelet for good
reason upon or within 12 months following a change in control, immediately upon
written notice of termination, or (vi) at the election of the company or Dr.
Martelet, upon written notice of termination.
42
Table of Contents
If
we elect to terminate Dr. Martelets employment, other than for cause, or
within 60 days prior to the expiration of the employment agreement, the company
and Dr. Martelet fail to agree to extend the employment agreement or otherwise
reach a mutually acceptable agreement to continue Dr. Martelets employment, we
will pay to Dr. Martelet the salary in effect on the date of termination for a
20 month period following the date of termination, plus medical and dental
benefits and any pro rata portion of any non-discretionary bonus.
If
we terminate Dr. Martelets employment for cause or Dr. Martelet elects to
terminate employment, other than for good reason, no severance or benefits will
be paid, and Dr. Martelet will be entitled only to receive payment of earned
but unpaid salary, and accrued vacation, as of the date of termination.
If
Dr. Martelet terminates employment for good reason, other than following a
change in control, we will pay Dr. Martelets then current salary for a 20
month period following the date of termination, plus medical and dental
benefits and the pro rata portion of any non-discretionary bonus earned.
If
we terminate the employment relationship upon or following a change in control,
or if Dr. Martelet terminates employment for good reason upon or following a
change in control, we will pay the then current annual salary in a lump sum
amount, calculated at two times the annual salary, plus medical and dental care
benefits and any pro rata portion of any non-discretionary bonus.
If,
prior to the expiration of the employment period, Dr. Martelets employment is
terminated by death or disability, we will pay to Dr. Martelet, the then
current base salary for a 20 month period in the case of death, and a six month
period in the case of disability, following the date of termination, plus
medical and dental benefits and any pro rata portion of any non-discretionary
bonus.
Dr.
Martelet has agreed that during the employment period and after the termination
of employment, for any reason, Dr. Martelet will not render services of any
nature, directly or indirectly, to any competing organization in connection
with any competing product within any geographical territory as the company and
the competing organization are or would be in actual competition, for a period
of 20 months, commencing on the date of termination. Additionally, Dr. Martelet
has agreed that he will not, during his employment and for a period of 20
months commencing on the date of termination, directly or indirectly employ,
solicit for employment, or advise or recommend to any other person that they
employ or solicit for employment, any person whom he knows to be an employee of
the company or any parent, subsidiary or affiliate of the company.
Richard P. Rainey.
On January 23, 2008, we
entered into and executed a new employment agreement with Mr. Rainey, effective
as of December 1, 2007, which sets forth the terms of Mr. Raineys continued
employment with us through May 31, 2008. The new agreement supersedes the
previous employment agreement between us and Mr. Rainey dated as of April 1,
2004, as amended by a letter agreement dated October 2, 2007, except as set
forth in the new agreement. Upon execution of the new agreement, Mr. Rainey received
a bonus payment of $350,000 for prior services rendered.
The
new agreement provides that Mr. Rainey will continue in employment with the
company until May 31, 2008, in the capacity of Principal Accounting Officer.
Under the terms of the new agreement, Mr. Rainey receives a base salary of
$275,000 per year. The new agreement also provides that Mr. Rainey will receive
a severance payment of $350,000, payable in 12 monthly installments, if (i) Mr.
Raineys employment is terminated without Cause, as defined below, (ii) upon
Mr. Raineys death or disability, (iii) after Achievement of the Milestones, as
defined below, (iv) due to Mr. Raineys resignation for Good Reason, as defined
below, or (v) upon the expiration of the employment term on May 31, 2008. The
new agreement also provides that the exercise date for all stock options held
by Mr. Rainey is extended 18 months from the termination date of Mr. Raineys
employment with us and that all such stock options will thereupon be
accelerated and fully vested as of the termination date, if the agreement is
terminated in a manner that triggers the severance payment described in the
preceding sentence. We may terminate Mr. Rainey for Cause or without Cause, Mr.
Rainey may terminate his employment for Good Reason, or no reason, and Mr.
Raineys employment will terminate at the end of the term of the employment
term on May 31, 2008, unless earlier terminated.
43
Table of Contents
For
purposes of the agreement, Cause for termination means (a) Mr. Raineys
material breach of, or habitual neglect or failure to perform the material
duties which he is required to perform under the terms of the agreement; the
willful or intentional failure to follow the reasonable directives or policies
established by us; or engaging in conduct that is materially detrimental to our
interests such that we sustain a material loss or injury as a result thereof,
provided that the breach or failure of performance by the Mr. Rainey has not
been cured by Mr. Rainey within 30 days after he shall have received written
notice from us stating with reasonable specificity the nature of such conduct;
(b) Mr. Raineys conviction or entry of nolo contendere to any felony or a
crime involving moral turpitude, fraud or embezzlement of our property; or (c)
Mr. Raineys material breach of his duties under the agreement. For purposes of
the agreement, Good Reason means, without Mr. Raineys written consent, (a) the
assignment to Mr. Rainey of duties inconsistent in any material respect with
the duties of a Principal Accounting Officer; or (b) a material reduction in
his base salary or other benefits. For purposes of the agreement, Achievement
of the Milestones, means the filing by the company of its Annual Report on
Form 10-KSB for the year ended December 31, 2007, and the filing and
effectiveness of a registration for a primary offering of securities by us, in
each instance, with the participation of Mr. Rainey in his capacity as
Principal Accounting Officer.
The
employment agreement also contains a nondisclosure agreement, a 12-month
covenant not to compete, and a 12- month non-solicitation agreement.
Dr.
David Berd.
Effective November 1, 2004, we entered
into an employment letter (the Employment Letter) with Dr. David Berd, under
which Dr. Berd was named the companys Chief Medical Officer. Dr. Berd is the
inventor of the AC Vaccine technology that we license from Thomas Jefferson
University. Dr. Berd has worked closely with us as a tenured professor at
Thomas Jefferson University and a consultant to us during the 10 year period in
which we have had the AC Vaccine in development. Dr. Berds initial employment
term with was for six months, running through April 30, 2005. This has been
repeatedly extended, most recently to October 31, 2007.
Under
the terms of the Employment Letter, Dr. Berd receives a current annual base
salary of $180,000 per year, payable pro rata for any partial calendar year for
which we employ Dr. Berd. Pursuant to the Employment Letter, Dr. Berd was
granted an option under the companys 2001 Stock Option Plan to purchase
200,000 shares of common stock exercisable for seven years at an exercise price
equal to $0.22 per share, which was the market value of the common stock as of
the effective date of the Employment Letter. The option vests at the rate of
25% per quarter until the first anniversary of the effective date.
CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS
On
April 13, 2007, we completed a private financing in the aggregate principal
amount of $10,007,500 at a price of $0.125 per share with various institution
and individual investors in reliance upon the exemption from registration in
Section 4(2) of the Securities Act of 1933. We issued 80,060,000 shares of our
common stock and associated warrants to purchase an additional 80,060,000
shares of common stock at an exercise price of $0.15 per share.
A
partnership in which Mr. Rainey, our then President and CEO, is a 50% partner
and Mr. Raineys brother is the other 50% partner, purchased $50,000 of common
stock and related warrants to purchase common stock in the April 2007 offering.
John K.A. Prendergast, Carl Spana and Andrew Dahl, directors of the company
also purchased $50,000, $20,000 and $20,000, respectively, of common stock and
associated warrants to purchase common stock, in this offering. The board of
directors approved the participation of Dr. Prendergast, Mr. Spana, Dr. Dahl and
Mr. Rainey in the private placement.
SECURITY OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth, as of December 31, 2007, certain information
regarding the beneficial ownership of the common stock (i) by each person known
by us to be the beneficial owner of more than five percent of the outstanding
shares of the common stock, (ii) by each of our Named Executive Officers (as
defined herein) and directors and (iii) by all our executive officers and
directors as a group.
44
Table of Contents
|
|
|
|
|
|
|
Name and
Address of Beneficial Owner
|
|
Title of
Stock
|
|
Amount and Nature
of
Beneficial Ownership
|
|
Percentage of Class
Beneficially Owned
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Named Officers and Directors
(2)
|
|
|
|
|
|
|
|
Francois R. Martelet, M.D.
|
|
Common Stock
|
|
150,000
|
|
|
*
|
Richard P. Rainey, C.P.A.
(3)
|
|
Common Stock
|
|
3,878,604
|
|
|
2.68%
|
Edson D. de Castro
(4)
|
|
Common Stock
|
|
245,000
|
|
|
*
|
Andrew W. Dahl, Sc.D.
(5)
|
|
Common Stock
|
|
565,000
|
|
|
*
|
John K.A. Prendergast, Ph.D.
(6)
|
|
Common Stock
|
|
1,908,736
|
|
|
1.33
|
Carl Spana, Ph.D.
(7)
|
|
Common Stock
|
|
844,292
|
|
|
*
|
David Berd, M.D.
(8)
|
|
Common Stock
|
|
629,121
|
|
|
*
|
|
|
|
|
|
|
|
|
All executive officers and directors as a group
(7 persons)
(9)
|
|
Common Stock
|
|
7,595,382
|
|
|
5.23
|
|
|
|
|
|
|
|
|
5% Stockholders
|
|
|
|
|
|
|
|
Carmignac Innovation Shares
(10)
c/o Natexis Banques Populaire
45 rue Saint Dominique
75007 Paris
|
|
Common Stock
|
|
16,000,000
|
|
|
10.62
|
|
|
|
|
|
|
|
|
Park Place Columbia LTD
(11)
Chancery Hall, 52 Reid Street
Hamilton HM 12 Bermuda
|
|
Common Stock
|
|
13,405,616
|
|
|
9.02
|
|
|
|
|
|
|
|
|
Aqua RIMCO LTD
(12)
1-5-8 Nishi-Shimbashi
Minato-Ku
Tokyo, Japan 105-0003
|
|
Common Stock
|
|
9,558,937
|
|
|
6.60
|
|
|
|
|
|
|
|
|
Firebird Global Master Fund, Ltd.
(13)
c/o Citco Fund Services (Cayman Islands) Limited
Regatta Office Park, West Bay Road
P.O. Box 31106 SMB
Grand Cayman, Cayman Islands
|
|
Common Stock
|
|
52,021,167
|
|
|
31.07
|
|
|
|
|
|
|
|
|
Yoshinori Shirono
(14)
Ebisu Prime Square, 1-1-39 Hiroo
Shibuya-Ku
Tokyo, Japan 150-0012
|
|
Common Stock
|
|
9,558,823
|
|
|
6.60
|
|
|
|
|
|
|
|
|
BioCentive
(15)
c/o Winchester Global Trust Co
PO Box HM 3396
Hamilton HM PX Bermuda
|
|
Common Stock
|
|
24,800,000
|
|
|
18.11
|
|
|
|
|
|
|
|
|
JFE Hottinger & Affiliates
(16)
Hottingerstrasse 21
CH-8032 Zurich
Switzerland
|
|
Common Stock
|
|
31,502,199
|
|
|
20.14
|
|
|
|
*Represents less than 1%.
|
|
(1)
|
The
percentage of common stock beneficially owned is determined by adding the
number of shares of common stock outstanding 142,605,753 as of December 31,
2007, to the number of shares issuable upon conversion of the Series C
preferred stock, 1,030,756 as of December 31, 2007, plus, for each beneficial
owner or group, any shares of common
stock that owner or group has the right to acquire within 60 days after
December 31, 2007, pursuant to options or warrants.
|
45
Table of Contents
|
|
(2)
|
The address
of the named individuals is c/o AVAX Technologies, Inc., 2000 Hamilton
Street, Suite 204, Philadelphia, Pennsylvania 19130.
|
(3)
|
Includes
867,500 shares of common stock that Mr. Rainey may acquire within 60 days
upon exercise of options held by Mr. Rainey and also includes 393,504 shares
and 384,600 warrants owned by a partnership in which Mr. Rainey holds a 50%
interest.
|
(4)
|
Represents
shares of common stock that Mr. de Castro may acquire within 60 days upon the
exercise of options held by Mr. de Castro.
|
(5)
|
Includes
245,000 shares of common stock that Dr. Dahl may acquire within 60 days upon
the exercise of options held by Dr. Dahl.
|
(6)
|
Includes
223,101 shares of common stock that Dr. Prendergast may acquire within 60
days upon exercise of options held by Dr. Prendergast and also includes
261,748 shares and 192,300 warrants owned by Dr. Prendergast.
|
(7)
|
Includes
376,250 shares of common stock that Dr. Spana may acquire within 60 days upon
the exercise of options held by Dr. Spana.
|
(8)
|
Includes
400,000 shares of common stock that Dr. Berd may acquire within 60 days upon
the exercise of options held by Dr. Berd.
|
(9)
|
Consists
only of directors and Richard P. Rainey, the sole executive officer of the
company as of the date of this proxy statement.
|
(10)
|
Includes
8,000,000 warrants to purchase common stock owned by Carmignac Gestion
|
(11)
|
Includes
6,067,600 warrants to purchase common stock owned by Park Place Columbia LTD.
|
(12)
|
Includes
2,205,908 warrants to purchase common stock owned by Aqua RIMCO LTD.
|
(13)
|
Includes
24,800,000 warrants to purchase common stock owned by Firebird Global Master
Fund, Ltd.
|
(14)
|
Includes
2,205,882 warrants to purchase common stock owned by Yoshinori Shirono.
|
(15)
|
Includes
14,200,000 warrants to purchase common stock owned by BioCentive Limited.
|
(16)
|
Includes
13,796,690 warrants to purchase common stock owned by JFE Hottinger &
Affiliates.
|
Equity Compensation Plan Information
The
following table sets forth as of December 31, 2007, (a) the number of
securities to be issued upon exercise of outstanding options, warrants and rights,
(b) the weighted average exercise price of outstanding options, warrants and
rights and (c) the number of securities remaining available for future issuance
under equity compensation plans (excluding securities reflected in column (a)).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
Plan
Category
|
|
Number of
securities to
be
issued upon exercise
of
outstanding options,
warrants and rights
|
|
Weighted-average
exercise
price of
outstanding
options,
warrants
and rights
|
|
Number of
securities
remaining
available for
future
issuance under
equity
compensation
plans
(excluding
securities
reflected in
column
(a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity compensation plans approved by
security holders
|
|
|
8,048,250
|
|
|
$
|
0.27
|
|
|
2,107,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity compensation plans not approved by
security holders
|
|
|
13,275,528
|
|
|
|
0.27
|
|
|
|
|
|
|
Total
|
|
|
21,323,778
|
|
|
|
|
|
|
2,107,144
|
|
|
46
Table of Contents
The
warrants and options issued without stockholder approval include: (1) warrants
to purchase 288,450 shares of common stock at an exercise price of $0.143 per
share issued to a broker in connection with the companys 2003 bridge
financing, which expire on December 1, 2008; (2) warrants to purchase 566,667
shares of common stock at an exercise price of $0.33 per share issued to a
broker in connection with the companys 2004 private placement of securities,
which expire on May 10, 2009; (3) warrants to purchase 2,287,293 shares of
common stock at an exercise price of $0.33 per share issued to two brokers in
connection with the companys 2005 private placement of securities, which
expire on May 10, 2009; (4) warrants to purchase 300,000 shares of common stock
at an exercise price of $0.14 per share issued to two individuals for certain
financial advisory services, which expire on December 16, 2009; (5) warrants to
purchase 270,000 shares of common stock at an exercise price of $0.35 per share
issued to two individuals for advisory services, which expire on October 31,
2012; and (6) warrants to purchase 6,270,400 shares of common stock at an exercise
price of $0.15 per share issued to three brokers in connection with the
companys 2007 private placement of securities.
The
warrants and options issued without stockholder approval also include 100,000
options to acquire common stock issued to current and former directors outside
of the companys stock option plans, which options were granted in conjunction
with services (including extraordinary levels of services) provided by those
directors to the company. Those options expire on November 2, 2008, and have
option exercise prices of $0.89 per share.
The
warrants and options issued without stockholder approval also includes 500,000
options issued to Richard Rainey, our then President and CEO, and 275,000
options issued to John Prendergast, our Chairman, which both have an exercise
price of $0.30 and expire on June 7, 2012. See Note 4 of the Notes to Financial
Statements for information concerning the material terms of equity compensation
plans pursuant to which the foregoing options and warrants have been issued.
These options were subsequently approved by shareholders at the 2006 annual
meeting of stockholders.
The
warrants and options issued without stockholder approval also include 6,130,288
options issued to Dr. Francois Martelet, our current President and CEO, which
have an exercise price of $0.09 and expire on December 1, 2014. These options
were granted to Dr. Martelet in conjunction with his appointment to President
and CEO of the company.
SHARES ELIGIBLE FOR
FUTURE SALES
After this
offering, we will have outstanding 392,605,753 shares of common stock
(based on shares outstanding as of December 31, 2007, and assuming all
250,000,000 shares are issued in this offering). Of these shares, an aggregate
of 301,090,908 shares, including the shares to be sold in this
offering, will be freely tradable without restriction under the Securities Act,
except for any shares purchased by one of our affiliates as defined in
Rule 144 under the Securities Act. At the conclusion of this offering, a
total of 91,814,845 shares will be restricted securities within the meaning
of Rule 144 under the Securities Act. Of these 91,814,845 restricted
shares, however, 80,060,000 are subject to certain registration rights granted
by the company, as described below. Except as noted in the preceding sentence,
the restricted securities generally may not be sold unless they are registered
under the Securities Act or are sold pursuant to an exemption from
registration, such as the exemption provided by Rule 144 under the
Securities Act.
We
have filed one registration statement on Form S-8, which is effective, to
register shares of common stock reserved for issuance under our stock option
plans. Shares issued under the plan may be sold in the open market, subject in
the case of certain holders, to the Rule 144 limitations applicable to
affiliates, and vesting restrictions imposed by us. As of December 31, 2007,
there were 8,048,250 shares subject to options outstanding under the plans.
47
Table of Contents
On
April 13, 2007, we closed a private placement of 80,060,000 shares of
common stock at a purchase price of $0.125 per share with 25 accredited or
institutional investors. We received gross proceeds of $10,007,500. In
connection with the private placement, we also issued to the investors warrants
to purchase 80,060,000 shares of common stock at a warrant exercise price of
$0.15 per share. In the securities purchase agreement relating to that
offering, we agreed to use our reasonable best efforts to file a registration
statement with the SEC to register the securities issued in that offering for
reoffer and resale by the investors. At this time, we have not filed that
registration statement. As of the date of this prospectus, no investor in that
offering has requested that we take steps to register their shares or warrants
for reoffer or resale.
PLAN OF DISTRIBUTION
We
may sell securities pursuant to this prospectus in or outside the U.S. (a)
through underwriters or dealers, (b) through agents or (c) in private sales
directly to one or more purchasers. The prospectus supplement relating to any
offering of securities will include the following information:
|
|
|
|
|
the terms of the offering;
|
|
|
|
|
|
the names of any
underwriters, and respective amounts underwritten;
|
|
|
|
|
|
the names of any dealers
or agents;
|
|
|
|
|
|
the name or names of any
managing underwriter or underwriters;
|
|
|
|
|
|
the purchase price of the
securities purchased from us;
|
|
|
|
|
|
the net proceeds to us
from the sale of the securities;
|
|
|
|
|
|
any delayed delivery
arrangements;
|
|
|
|
|
|
any underwriting
discounts, commissions and other items constituting underwriters
compensation;
|
|
|
|
|
|
any initial public
offering price;
|
|
|
|
|
|
any discounts or
concessions allowed or reallowed or paid to dealers; and
|
|
|
|
|
|
any commissions paid to
agents.
|
Sale Through Underwriters or
Dealers
If
we use underwriters in the sale, the underwriters will acquire the securities
for their own account. The underwriters may resell the securities from time to
time in one or more transactions, including negotiated transactions, at a fixed
public offering price at varying prices determined at the time of sale.
Underwriters may offer securities to the public either through underwriting
syndicates represented by one or more managing underwriters or directly by one
or more firms acting as underwriters. Unless we inform you otherwise in the
prospectus supplement, the obligations of the underwriters to purchase the
securities will be subject to certain conditions, and the underwriters will be
obligated to purchase all the offered securities if they purchase any of them.
The underwriters may change from time to time any initial public offering price
and any discounts or concessions allowed or reallowed or paid to dealers.
During
and after an offering through underwriters, the underwriters may purchase and
sell the securities in the open market. These transactions may include
stabilizing transactions, over-allotment transactions, syndicate covering
transactions and penalty bids in accordance with Regulation M under the
Securities Exchange Act of 1934.
48
Table of Contents
Stabilizing
transactions permit bids to purchase the underlying security so long as the
stabilizing bids do not exceed a specified maximum.
Over-allotment
transactions involve sales by the underwriters of securities in excess of the
number of securities the underwriters are obligated to purchase, which creates
a syndicate short position. The short position may be either a covered short
position or a naked short position. In a covered short position, the number of
securities over-allotted by the underwriters is not greater than the number of
securities that they may purchase in the over-allotment option. In a naked
short position, the number of securities involved is greater than the number of
securities in the over-allotment option. The underwriters may close out any
covered short position by either exercising their over-allotment option or
purchasing securities in the open market.
Syndicate
covering transactions involve purchases of the securities in the open market
after the distribution has been completed in order to cover syndicate short
positions. In determining the source of securities to close out the short
position, the underwriters will consider, among other things, the price of
securities available for purchase in the open market as compared to the price
at which they may purchase securities through the over-allotment option. If the
underwriters sell more securities than could be covered by the over-allotment
option, a naked short position, the position can only be closed out by buying
securities in the open market. A naked short position is more likely to be
created if the underwriters are concerned that there could be downward pressure
on the price of the securities in the open market after pricing that could
adversely affect investors who purchase in the offering.
Penalty
bids permit the representatives to reclaim a selling concession from a
syndicate member when the common stock originally sold by the syndicate member
is purchased in a stabilizing or syndicate covering transaction to cover
syndicate short positions.
These
stabilizing transactions, syndicate covering transactions and penalty bids may
have the effect of raising or maintaining the market price of the offered
securities or preventing or retarding a decline in the market price of the
offered securities. As a result, the price of the offered securities may be
higher than the price that might otherwise exist in the open market. These
transactions may be effected on the Nasdaq Global Market or otherwise and, if
commenced, may be discontinued at any time.
If
we use dealers in the sale of securities, the securities will be sold directly
to them as principals. They may then resell those securities to the public at
varying prices determined by the dealers at the time of resale.
Direct Sales and Sales Through
Agents
We
may sell the securities directly. In this case, no underwriters or agents would
be involved. We may sell securities upon the exercise of rights that we may
issue to our security holders. We may also sell the securities directly to
institutional investors or others who may be deemed to be underwriters within
the meaning of the Securities Act of 1933 with respect to any resale of those
securities.
We
may sell the securities through agents we designate from time to time. Unless
we inform you otherwise in the prospectus supplement, any agent will agree to
use its reasonable best efforts to solicit purchases for the period of its
appointment.
General Information
We
may have agreements with the agents, dealers and underwriters to indemnify them
against certain civil liabilities, including liabilities under the Securities
Act of 1933, or to contribute with respect to payments that the agents, dealers
on underwriters may be required to make. Agents, dealers and underwriters may
be customers of, engage in transactions with, or perform services for us in the
ordinary course of their business.
49
Table of Contents
DESCRIPTION OF
CAPITAL STOCK
We
are authorized to issue up to 500,000,000 shares of our common stock, par value $.004 per share, and 5,000,000 shares of
our preferred stock, par value, $.01 per share. As of December 31, 2007,
141,574,997 shares of common stock
and 33,500 shares of Series C Preferred Stock were issued and outstanding.
Common Stock
Each
holder of our common stock is
entitled to one vote for each share held of record. There is no right to
cumulative voting of shares for the election of directors. The shares of common stock are not entitled to preemptive
rights and are not subject to redemption or assessment. Each share of common stock is entitled to share ratably
in distributions to stockholders and to receive ratably such dividends as may
be declared by the board of directors out of funds legally available therefor.
Upon our liquidation, dissolution or winding up, the holders of common stock are entitled to receive,
pro-rata, our assets which are legally available for distribution to
stockholders. The issued and outstanding shares of common stock are validly issued, fully paid and non-assessable.
Preferred Stock
We
are authorized to issue up to 5,000,000 shares of preferred stock, par value
$.01 per share. Our preferred stock can be issued in one or more series as may
be determined from time-to-time by the board of directors. In establishing a
series the board of directors shall give to it a distinctive designation so as
to distinguish it from the shares of all other series and classes, shall fix
the number of shares in such series, and the preferences, rights and
restrictions thereof. All shares of any one series shall be alike in every
particular. The board of directors has the authority, without stockholder
approval, to fix the rights, preferences, privileges and restrictions of any
series of preferred stock including, without limitation: (a) the rate of
distribution, (b) the price at and the terms and conditions on which shares
shall be redeemed, (c) the amount payable upon shares for distributions of any
kind, (d) the terms and conditions on which shares may be converted if the
shares of any series are issued with the privilege of conversion and (e) voting
rights except as limited by law.
Although
we currently do not have any plans to issue additional shares of preferred
stock or to designate a new series of preferred stock, there can be no
assurance that we will not do so in the future. As a result, we could authorize
the issuance of a series of preferred stock which would grant to holders
preferred rights to our assets upon liquidation, the right to receive dividend
coupons before dividends would be declared to holders of common stock, and the right to the
redemption of such shares, together with a premium, prior to the redemption to common stock. Our current stockholders have
no redemption rights. In addition, the Board could issue large blocks of voting
stock to fend off unwanted tender offers or hostile takeovers without further
stockholder approval.
Series A Preferred
Stock
At
one time, we had designated and issued shares of Series A Preferred Stock, par
value $.01 per share. Pursuant to an automatic conversion provision in the Certificate
of Designations therefor, all outstanding shares of Series A Preferred Stock
were converted into shares of common stock
effective June 1996. Thereafter, the Series A Preferred Stock was eliminated
pursuant to a Certificate of Elimination filed by us.
Series B Preferred
Stock
At
one time, we had designated and issued shares of Series B Preferred Stock, par
value $.01 per share. Pursuant to an automatic conversion provision in the
Certificate of Designations therefor, all outstanding shares of Series B
Preferred Stock were converted into shares of common
stock in March 2000. Thereafter, the Series B Preferred Stock was
eliminated pursuant to a Certificate of Elimination filed by us.
50
Table of Contents
Series C Preferred
Stock
Our
board of directors has authorized the issuance of up to 120,000, of which
33,500 are outstanding, shares of Series C Preferred Stock, par value $.01 per
share, the rights, preferences and characteristics which include a liquidation
preference in the amount of $100 per share (cumulative preference amount of
$3,350,000) in the event of: (1) a liquidation, (2) if we cease to exist as a
result of a merger in which we are not the surviving corporation, or (3) if one
person or entity acquires more than 50% of the voting power of our company.
Dividends
The
holders of Series C Preferred Stock are entitled to receive dividends as, when
and if declared by our board of directors out of funds legally available
therefor. If we declare a dividend or distribution on the common stock, the holders of the Series C
Preferred Stock will be entitled to receive for each share of Series C
Preferred Stock a dividend or distribution in the amount of the dividend or
distribution that would be received by a holder of Common Stock into which each
share of Series C Preferred Stock is convertible on the record day of the
dividend or distribution. We do not intend to pay cash dividends on the Series
C Preferred Stock or the underlying common
stock for the foreseeable future.
Conversion
Each
share of Series C Preferred Stock is convertible, in whole or part, at the
option of the holder at any time after the initial issuance date into 30.76923
shares of common stock based upon an
initial conversion price of $3.25 per share of common stock (the Initial Conversion Price). The conversion price
is subject to adjustment upon the occurrence of certain mergers,
reorganizations, consolidations, reclassifications, stock dividends or stock
splits which will result in an increase or decrease in the number of shares of common stock outstanding.
Mandatory Conversion
We
have the right at any time to cause the Series C Preferred Stock to be
converted in whole or in part, on a pro rata basis, into shares of common stock if the common stock is then listed on the Nasdaq
National Market System
and the closing price of the common stock
exceeds 300% of the then applicable conversion price for at least 20 trading
days in any 30 consecutive trading day period.
Liquidation
Upon
(i) our liquidation, dissolution or winding up, whether voluntary or
involuntary, (ii) a sale or other disposition of all or substantially all of
our assets or (iii) merger or consolidation (a Merger Transaction) in which we
are not the surviving entity and shares of common
stock consisting in excess of 50% of the voting power of our company are
exchanged (subparagraphs (i), (ii) and (iii) being collectively referred to as
a Liquidation Event), after payment or provision for payment of the debts and
other liabilities, the holders of the Series C Preferred Stock then outstanding
will first be entitled to receive, pro rata (on the basis of the number of
shares of the preferred stock then outstanding), and in preference to the
holders of the common stock and any
other series of junior stock, an amount per share equal to $100.00 plus accrued
but unpaid dividends, if any (the Liquidating Payment); provided, however, that
in the case of a Merger Transaction, such $100.00 per share may be paid in cash
and/or securities of the surviving entity in such Merger Transaction. In the
case of any Liquidation Event, after payment to the holders of the Series C
Preferred Stock of the Liquidating Payment, each share of Series C Preferred
Stock then outstanding will be converted into the kind and amount of shares of
stock or other consideration receivable in connection with such transaction by
a holder of the number of shares of common
stock into which such share of Series C Preferred Stock could have been
converted immediately prior to such transaction.
Voting Rights
The
holders of the Series C Preferred Stock have the right at all meetings of
stockholders to the number of votes equal to the number of shares of common stock issuable upon conversion of
the Series C Preferred Stock at the record date for determination of the
stockholders entitled to vote. So long as 25% of the shares of Series C
Preferred Stock initially issued remain outstanding, the holders of 66.67% of
the Series C Preferred Stock are entitled to approve (i) any amendment to the
Certificate of Incorporation or our Bylaws that would affect adversely the
relative rights, preferences, qualifications, limitations or restrictions of
the Series C Preferred Stock, or (ii) any authorization or issuance or any
increase in the authorized amount of any class or series of stock or any
security convertible into stock of such class or series ranking prior to the
Series C Preferred Stock upon our liquidation, dissolution or winding up or a
sale of all or substantially all of our assets or as to any dividends or
distributions. Except as provided above or as required by applicable law, the
holders of the Series C Preferred Stock will be entitled to vote together with
the holders of the common stock and
not as a separate class.
51
Table of Contents
Transfer
Agent
The
transfer agent for our common stock is Computershare Trust Company, N.A.
Indemnification
for Securities Act Liabilities
Our
Certificate of Incorporation, our Bylaws and Delaware corporation law are broad
enough to authorize the indemnification of our directors and officers under
certain circumstances for liabilities, including reimbursement for expenses
incurred, arising under the Securities Act of 1933, as amended. Insofar as indemnification for liabilities arising
under the Securities Act of 1933, as amended, may be permitted to directors,
officers and controlling persons of a small business issuer pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion of
the SEC such indemnification is against public policy as expressed in the
Securities Act of 1933, as amended, and is, therefore, unenforceable.
LEGAL MATTERS
The
validity of shares of common stock being offered pursuant to this prospectus
will be passed upon for us by Gilmore & Bell, P.C., Kansas City, Missouri.
EXPERTS
Our consolidated financial statements for the
years ended December 31, 2005 and 2006, and for the period from January 12,
1990 (Incorporation) to December 31, 2006, appearing in this prospectus and
registration statement have been audited by Briggs, Bunting & Dougherty
LLP, independent registered public accounting firm, as set forth in their
report thereon appearing elsewhere herein. These financial statements are
included in reliance upon the report given on the authority of Briggs, Bunting
& Dougherty LLP as experts in accounting and auditing.
WHERE YOU CAN
FIND MORE INFORMATION
We
are a reporting company as that term is used in the Securities Exchange Act of
1934. As a reporting company, we are required to file reports, proxy statements
and other information with the Securities and Exchange Commission, including
the information listed below. You may read and copy any of the reports, proxy
statements and other information that we have filed with the Securities and
Exchange Commission at the Securities and Exchange Commissions Public
Reference Room, located at 100 F Street, N.E., Washington, D.C. 20549. You may
get information on the operation of the Public Reference Room by calling the Securities
and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange
Commission maintains an Internet site that contains reports, proxy and
information statements, and other information regarding us and other issuers
that electronically file information with the Securities and Exchange
Commission. The address of that site is (http://www.sec.gov). Our Web site is
(www.avax-tech.com). Our website and the information contained on our website
are not incorporated into this prospectus or the registration statement of
which it forms a part.
This
prospectus constitutes a part of a registration statement on Form S-1 filed by
us with the Securities and Exchange Commission under the Securities Act of
1933. You may want to refer directly to the registration statement for more
information about us and our common stock. You may want to review a copy of any
contract or document filed as an exhibit to the registration statement. We are
a small business issuer as that term is defined in Rule 405 under the
Securities Act of 1933.
52
Table of Contents
INDEX TO FINANCIAL STATEMENTS
|
|
|
Audited
Consolidated Financial Statements
|
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
|
F-1
|
Consolidated
Balance Sheet as of December 31, 2006
|
|
F-2
|
Consolidated
Statements of Operations and Comprehensive Loss for the years ended December
31, 2006 and 2005 and for the period from January 12, 1990 (incorporation) to
December 31, 2006
|
|
F-3
|
Consolidated
Statements of Stockholders Equity (Deficit) for the years ended December 31,
2006 and 2005 and for the period from January 12, 1990 (incorporation) to
December 31, 2006
|
|
F-4
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2006 and 2005 and
for the period from January 12, 1990 (incorporation) to December 31, 2006
|
|
F-8
|
Notes
to Consolidated Financial Statements
|
|
F-10
|
|
|
|
Unaudited
Consolidated Financial Statements
|
|
|
|
|
|
Consolidated
Balance Sheets As of December 31, 2006 and September 30, 2007 (Unaudited)
|
|
F-24
|
Consolidated
Statements of Operations and comprehensive Income (Loss)(Unaudited) For the
Three and Nine Months Ended September 30, 2007 and 2006 and for the Period
from January 12, 1990 (Incorporation) through September 30, 2007
|
|
F-25
|
Consolidated
Statements of Cash Flows (Unaudited) For the Nine Months Ended
September 30, 2007 and 2006 and for the Period from January 12,
1990 (Incorporation) through September 30, 2007
|
|
F-26
|
Notes
to Consolidated Financial Statements (Unaudited)
|
|
F-28
|
Index
Report
of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
AVAX Technologies, Inc.
We have audited the accompanying consolidated balance
sheet of AVAX Technologies, Inc. (a development stage company) and subsidiaries
as of December 31, 2006, and the related consolidated statements of operations
and comprehensive loss, stockholders equity (deficit), and cash flows for each
of the two years in the period then ended and for the period from January 12,
1990 (incorporation) to December 31, 2006. These financial statements are the
responsibility of the Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the
standards of the Public Company Accounting Oversight Board (United States).
Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to
above present fairly, in all material respects, the consolidated financial
position of AVAX Technologies, Inc. and subsidiaries as of December 31, 2006,
and the consolidated results of their operations and their cash flows for each
of the two years in the period then ended and for the period from January 12,
1990 (incorporation) to December 31, 2006 in conformity with U.S. generally
accepted accounting principles.
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern.
As discussed in Note 1 to the consolidated financial statements, the Company
has incurred recurring losses from operations and may not have adequate capital
to fund its operations through 2007. These conditions raise substantial doubt
about the Companys ability to continue as a going concern. Managements plans
concerning these matters are also described in Note 1. The consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
As discussed in Note 1 to the financial statements,
effective January 1, 2006, the Company changed its method of accounting for
stock-based compensation in accordance with the Statement of Financial
Accounting Standards No. 123 (Revised 2004), Share-Based Payment.
/s/ Briggs,
Bunting & Dougherty, LLP
Philadelphia, Pennsylvania
May 7, 2007
F-1
Index
|
AVAX
Technologies, Inc. and Subsidiaries
|
(a development stage company)
|
Consolidated
Balanc
e Sheet
|
|
|
|
|
|
|
|
December 31,
2006
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash
|
|
$
|
1,484,570
|
|
Accounts
receivable
|
|
|
220,161
|
|
Inventory
|
|
|
10,508
|
|
VAT receivable
|
|
|
50,937
|
|
Prepaid expenses
and other current assets
|
|
|
210,343
|
|
|
|
|
|
|
Total current assets
|
|
|
1,976,519
|
|
Property, plant and equipment, at cost
|
|
|
3,967,928
|
|
Less accumulated
depreciation
|
|
|
3,088,687
|
|
|
|
|
|
|
Net property, plant and equipment
|
|
|
879,241
|
|
Goodwill
|
|
|
188,387
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,044,147
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders
equity
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
and accrued expenses
|
|
$
|
1,460,644
|
|
Accrued and
withheld payroll taxes and liabilities
|
|
|
716,918
|
|
Deferred revenue
|
|
|
160,678
|
|
ANVAR advances
|
|
|
362,109
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,700,349
|
|
Stockholders equity
:
|
|
|
|
|
Preferred stock,
$.01 par value:
|
|
|
|
|
Authorized
shares 5,000,000, including Series C 120,000 shares
|
|
|
|
|
Series C
convertible preferred stock:
|
|
|
|
|
Issued and
outstanding shares 36,750 (liquidation preference - $3,675,000)
|
|
|
367
|
|
Common stock,
$.004 par value:
|
|
|
|
|
Authorized
shares 150,000,000
|
|
|
|
|
Issued and
outstanding shares 61,414,998
|
|
|
245,660
|
|
Additional
paid-in capital
|
|
|
77,460,158
|
|
Subscription
receivable
|
|
|
(422
|
)
|
Accumulated
other comprehensive income
|
|
|
479,217
|
|
Deficit
accumulated during the development stage
|
|
|
(77,841,182
|
)
|
|
|
|
|
|
Total stockholders equity
|
|
|
343,798
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
3,044,147
|
|
|
|
|
|
|
See
accompanying notes.
F-2
Index
|
AVAX
Technologies, Inc. and Subsidiaries
|
(a development stage company)
|
Consolidated
Statements of Operations and Comprehensive Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
Period from
January 12, 1990
(Incorporation) to
December 31,
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
Gain from sale
of the Product
|
|
$
|
|
|
$
|
|
|
$
|
1,951,000
|
|
Product and
contract service revenue
|
|
|
734,774
|
|
|
1,623,701
|
|
|
6,404,822
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
734,774
|
|
|
1,623,701
|
|
|
8,355,822
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
4,244,268
|
|
|
3,534,948
|
|
|
47,651,768
|
|
Acquired in
process research and development
|
|
|
|
|
|
|
|
|
4,420,824
|
|
Write down of
acquired intellectual property and other intangibles
|
|
|
|
|
|
|
|
|
3,416,091
|
|
Amortization of
acquired intangibles
|
|
|
|
|
|
|
|
|
715,872
|
|
Selling, general
and administrative
|
|
|
1,989,188
|
|
|
1,933,911
|
|
|
35,245,089
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
loss
|
|
|
(5,498,682
|
)
|
|
(3,845,158
|
)
|
|
(83,093,822
|
)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
143,182
|
|
|
141,390
|
|
|
5,925,359
|
|
Interest expense
|
|
|
|
|
|
|
|
|
(812,067
|
)
|
Other, net
|
|
|
|
|
|
|
|
|
143,193
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other
income (expense), net
|
|
|
143,182
|
|
|
141,390
|
|
|
5,256,485
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before
income taxes
|
|
|
(5,355,500
|
)
|
|
(3,703,768
|
)
|
|
(77,837,337
|
)
|
Income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
continuing operations
|
|
|
(5,355,500
|
)
|
|
(3,703,768
|
)
|
|
(77,837,337
|
)
|
Loss from
discontinued operations
|
|
|
|
|
|
|
|
|
(3,845
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(5,355,500
|
)
|
|
(3,703,768
|
)
|
|
(77,841,182
|
)
|
Amount payable
for liquidation preference
|
|
|
|
|
|
|
|
|
(1,870,033
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders
|
|
$
|
(5,355,500
|
)
|
$
|
(3,703,768
|
)
|
$
|
(79,711,215
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common
share basic and diluted
|
|
|
|
|
|
|
|
|
|
|
Loss from
continuing operations
|
|
$
|
(0.09
|
)
|
$
|
(0.07
|
)
|
|
|
|
Loss from
discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(0.09
|
)
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of common shares outstanding
|
|
|
61,414,998
|
|
|
54,818,763
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,355,500
|
)
|
$
|
(3,703,768
|
)
|
|
|
|
Foreign currency
translation adjustment
|
|
|
23,535
|
|
|
28,864
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
|
(5,331,965
|
)
|
$
|
(3,674,904
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes.
F-3
Index
|
AVAX
Technologies, Inc. and Subsidiaries
|
(a development stage company)
|
Consolidated
Statements of Stockholders Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock for services in January 1990
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
582,500
|
|
$
|
2,330
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
582,500
|
|
|
2,330
|
|
Issuance of
common stock for services in August 1991
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
230,000
|
|
|
920
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1991
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
812,500
|
|
|
3,250
|
|
Conversion of
note payable to related party to common stock in June 1992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,913
|
|
|
92
|
|
Issuance of
common stock for services in May and June 1992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
264,185
|
|
|
1,056
|
|
Issuance of
Series A convertible preferred stock, net of issuance cost in June, July and September
1992
|
|
|
1,287,500
|
|
|
12,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1992
|
|
|
1,287,500
|
|
|
12,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,099,598
|
|
|
4,398
|
|
Issuance of
common stock for services in July and November 1993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,717
|
|
|
35
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1993
|
|
|
1,287,500
|
|
|
12,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,108,315
|
|
|
4,433
|
|
Issuance of
common stock for services in July 1994
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,750
|
|
|
15
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1994
|
|
|
1,287,500
|
|
|
12,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,112,065
|
|
|
4,448
|
|
Common stock
returned and canceled in April and May 1995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(307,948
|
)
|
|
(1,232
|
)
|
Shares issued in
September and November 1995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,777,218
|
|
|
7,109
|
|
Amount payable
for liquidation preference
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1995
|
|
|
1,287,500
|
|
|
12,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,581,335
|
|
|
10,325
|
|
Repurchase of
common stock in March 1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(77,901
|
)
|
|
(312
|
)
|
Payment of
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of
Series A preferred stock in June 1996
|
|
|
(1,287,500
|
)
|
|
(12,875
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
321,875
|
|
|
1,288
|
|
[TABLE CONTINUES]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
Paid-In
Capital
|
|
Subscription
Receivable
|
|
Deferred
Compensation
|
|
Unrealized
Loss on
Marketable
Securities
|
|
Accumulated
Other
Comprehensive
Income
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
Total
Stockholders Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock for services in January 1990
|
|
$
|
920
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
3,250
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(889
|
)
|
|
(889
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1990
|
|
|
920
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(889
|
)
|
|
2,361
|
|
Issuance of
common stock for services in August 1991
|
|
|
5,830
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,750
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97,804
|
)
|
|
(97,804
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1991
|
|
|
6,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(98,693
|
)
|
|
(88,693
|
)
|
Conversion of
note payable to related party to common stock in June 1992
|
|
|
160,465
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
160,557
|
|
Issuance of
common stock for services in May and June 1992
|
|
|
6,444
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,500
|
|
Issuance of
Series A convertible preferred stock, net of issuance cost in June, July and
September 1992
|
|
|
2,258,837
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,271,712
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(607,683
|
)
|
|
(607,683
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1992
|
|
|
2,432,496
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(706,376
|
)
|
|
1,743,393
|
|
Issuance of
common stock for services in July and November 1993
|
|
|
24,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,610,154
|
)
|
|
(1,610,154
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1993
|
|
|
2,457,461
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,316,530
|
)
|
|
158,239
|
|
Issuance of
common stock for services in July 1994
|
|
|
4,485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,500
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(781,221
|
)
|
|
(781,221
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1994
|
|
|
2,461,946
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,097,751
|
)
|
|
(618,482
|
)
|
Common stock
returned and canceled in April and May 1995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,232
|
)
|
Shares issued in
September and November 1995
|
|
|
|
|
|
(7,109
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount payable
for liquidation preference
|
|
|
(738,289
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(738,289
|
)
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,380,571
|
|
|
1,380,571
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1995
|
|
|
1,723,657
|
|
|
(7,109
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,717,180
|
)
|
|
22,568
|
|
Repurchase of
common stock in March 1996
|
|
|
|
|
|
312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of
subscription receivable
|
|
|
|
|
|
2,771
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,771
|
|
Conversion of
Series A preferred stock in June 1996
|
|
|
11,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-4
Index
AVAX Technologies, Inc. and Subsidiaries
(a development stage company)
Consolidated
Statements of Stockholders Equity (Deficit) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock and Series B preferred stock in a private placement in May and
June 1996
|
|
|
|
|
|
|
|
|
258,198
|
|
|
2,582
|
|
|
|
|
|
|
|
|
129,099
|
|
|
516
|
|
Issuance of
common stock and Series B preferred stock for services in June 1996
|
|
|
|
|
|
|
|
|
1,000
|
|
|
10
|
|
|
|
|
|
|
|
|
500
|
|
|
2
|
|
Exercise of
warrants in June and July 1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
156,250
|
|
|
626
|
|
Amount payable
for liquidation preference
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation
related to stock options granted in May and September 1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss
on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1996
|
|
|
|
|
|
|
|
|
259,198
|
|
|
2,592
|
|
|
|
|
|
|
|
|
3,111,158
|
|
|
12,445
|
|
Payment of
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of
warrants in April and June 1997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49,770
|
|
|
199
|
|
Conversion of
preferred to common stock
|
|
|
|
|
|
|
|
|
(55,039
|
)
|
|
(551
|
)
|
|
|
|
|
|
|
|
1,421,403
|
|
|
5,685
|
|
Repurchase of
fractional shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26
|
)
|
|
|
|
Realization of
loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1997
|
|
|
|
|
|
|
|
|
204,159
|
|
$
|
2,041
|
|
|
|
|
|
|
|
|
4,582,305
|
|
|
18,329
|
|
Conversion of
preferred to common stock
|
|
|
|
|
|
|
|
|
(91,470
|
)
|
|
(914
|
)
|
|
|
|
|
|
|
|
2,386,174
|
|
|
9,544
|
|
Payment of
subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue shares
based upon reset provisions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,029,339
|
|
|
12,117
|
|
Issue
compensatory shares to officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,301
|
|
|
38
|
|
Amortization of
deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 1998
|
|
|
|
|
|
|
|
|
112,689
|
|
|
1,127
|
|
|
|
|
|
|
|
|
10,007,119
|
|
|
40,028
|
|
Conversion of preferred to common stock
|
|
|
|
|
|
|
|
|
(38,805
|
)
|
|
(388
|
)
|
|
|
|
|
|
|
|
1,012,286
|
|
|
4,049
|
|
Issue shares based upon reset provisions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,885
|
|
|
84
|
|
Issuance of Series C preferred stock in a private placement in March
1999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101,300
|
|
|
1,013
|
|
|
|
|
|
|
|
Exercise of Warrants pursuant to cashless exercise provisions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,500
|
|
|
150
|
|
Capital contributed through sale of 20% interest in consolidated
subsidiaries to unrelated third party
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[TABLE CONTINUES]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
Paid-In
Capital
|
|
Subscription
Receivable
|
|
Deferred
Compensation
|
|
Unrealized
Loss on
Marketable
Securities
|
|
Accumulated
Other
Comprehensive
Income
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
Total
Stockholders
Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock and Series B preferred stock in a private placement in May and
June 1996
|
|
|
22,217,397
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,220,495
|
|
Issuance of
common stock and Series B preferred stock for services in June 1996
|
|
|
99,988
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000
|
|
Exercise of
warrants in June and July 1996
|
|
|
5,624
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,250
|
|
Amount payable
for liquidation preference
|
|
|
(1,131,744
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,131,744
|
)
|
Compensation
related to stock options granted in May and September 1996
|
|
|
1,076,373
|
|
|
|
|
|
(1,076,373
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred compensation
|
|
|
|
|
|
|
|
|
112,949
|
|
|
|
|
|
|
|
|
|
|
|
112,949
|
|
Unrealized loss
on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
(2,037
|
)
|
|
|
|
|
|
|
|
(2,037
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,536,842
|
)
|
|
(1,536,842
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1996
|
|
|
24,002,882
|
|
|
(4,026
|
)
|
|
(963,424
|
)
|
|
(2,037
|
)
|
|
|
|
|
(3,254,022
|
)
|
|
19,794,410
|
|
Payment of
subscription receivable
|
|
|
|
|
|
1,761
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,761
|
|
Write-off of
subscription receivable
|
|
|
(1,833
|
)
|
|
1,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of
warrants in April and June 1997
|
|
|
(199
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of
preferred to common stock
|
|
|
(5,134
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase of
fractional shares
|
|
|
(76
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(76
|
)
|
Realization of
loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
2,037
|
|
|
|
|
|
|
|
|
2,037
|
|
Amortization of
deferred compensation
|
|
|
|
|
|
|
|
|
269,100
|
|
|
|
|
|
|
|
|
|
|
|
269,100
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,266,125
|
)
|
|
(4,266,125
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 1997
|
|
|
23,995,640
|
|
|
(432
|
)
|
|
(694,324
|
)
|
|
|
|
|
|
|
|
(7,520,147
|
)
|
|
15,801,107
|
|
Conversion of
preferred to common stock
|
|
|
(8,630
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of
subscription receivable
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
Issue shares
based upon reset provisions
|
|
|
(12,117
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue
compensatory shares to officer
|
|
|
24,962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
Amortization of deferred
compensation
|
|
|
|
|
|
|
|
|
269,100
|
|
|
|
|
|
|
|
|
|
|
|
269,100
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,838,130
|
)
|
|
(5,838,130
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 1998
|
|
|
23,999,855
|
|
|
(422
|
)
|
|
(425,224
|
)
|
|
|
|
|
|
|
|
(13,358,277
|
)
|
|
10,257,087
|
|
Conversion of preferred to common stock
|
|
|
(3,661
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue shares based upon reset provisions
|
|
|
(84
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series C preferred stock in a private placement in March
1999
|
|
|
9,283,726
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,284,739
|
|
Exercise of Warrants pursuant to cashless exercise provisions
|
|
|
27,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,150
|
|
Capital contributed through sale of 20% interest in consolidated
subsidiaries to unrelated third party
|
|
|
2,099,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,099,200
|
|
F-5
Index
AVAX Technologies, Inc. and Subsidiaries
(a
development stage company)
Consolidated
Statements of Stockholders Equity (Deficit) (continued
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 1999
|
|
|
|
|
|
|
|
|
73,884
|
|
|
739
|
|
|
101,300
|
|
|
1,013
|
|
|
11,077,790
|
|
|
44,311
|
|
Conversion of preferred to common stock
|
|
|
|
|
|
|
|
|
(73,884
|
)
|
|
(739
|
)
|
|
(14,550
|
)
|
|
(146
|
)
|
|
2,375,083
|
|
|
9,500
|
|
Private placement of common stock, March 2000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,259,494
|
|
|
9,039
|
|
Capital contribution by shareholder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options and warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,254
|
|
|
117
|
|
Shares issued pursuant to acquisition of Subsidiary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
800,000
|
|
|
3,200
|
|
Elimination of contributed capital related to joint venture no longer
consolidated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
86,750
|
|
|
867
|
|
|
16,541,621
|
|
|
66,167
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
86,750
|
|
|
867
|
|
|
16,541,621
|
|
|
66,167
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
86,750
|
|
|
867
|
|
|
16,541,621
|
|
|
66,167
|
|
Conversion of preferred to common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,000
|
)
|
|
(500
|
)
|
|
1,538,450
|
|
|
6,153
|
|
Common stock warrants issued in conjunction with convertible notes
payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,750
|
|
|
367
|
|
|
18,080,071
|
|
|
72,320
|
|
Exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
338,400
|
|
|
1,354
|
|
Conversion of bridge notes to common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,486,430
|
|
|
29,945
|
|
Private placement of common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,166,667
|
|
|
40,667
|
|
Issuance of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
36,750
|
|
$
|
367
|
|
|
36,071,568
|
|
$
|
144,286
|
|
Private placement of common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,343,430
|
|
|
101,374
|
|
Issuance of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
36,750
|
|
$
|
367
|
|
|
61,414,998
|
|
$
|
245,660
|
|
[TABLE CONTINUES]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
Paid-In
Capital
|
|
Subscription
Receivable
|
|
Deferred
Compensation
|
|
Unrealized
Loss on
Marketable
Securities
|
|
Accumulated
Other
Comprehensive
Income
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
Total
Stockholders
Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
269,100
|
|
|
|
|
|
|
|
|
|
|
|
269,100
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,867,563
|
)
|
|
(7,867,563
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 1999
|
|
|
35,406,036
|
|
|
(422
|
)
|
|
(156,124
|
)
|
|
|
|
|
|
|
|
(21,225,840
|
)
|
|
14,069,713
|
|
Conversion of preferred to common stock
|
|
|
(8,615
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private placement of common stock, March 2000
|
|
|
24,186,656
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,195,695
|
|
Capital contribution by shareholder
|
|
|
93,637
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
93,637
|
|
Exercise of options and warrants
|
|
|
271,273
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
271,390
|
|
Shares issued pursuant to acquisition of Subsidiary
|
|
|
7,596,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,600,000
|
|
Elimination of contributed capital related to joint venture no longer
consolidated
|
|
|
(2,099,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,099,200
|
)
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
156,124
|
|
|
|
|
|
|
|
|
|
|
|
156,124
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80,009
|
|
|
|
|
|
80,009
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,276,749
|
)
|
|
(16,276,749
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2000
|
|
|
65,446,587
|
|
|
(422
|
)
|
|
|
|
|
|
|
|
80,009
|
|
|
(37,502,589
|
)
|
|
28,090,619
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,894
|
)
|
|
|
|
|
(38,894
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,109,753
|
)
|
|
(15,109,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
65,446,587
|
|
|
(422
|
)
|
|
|
|
|
|
|
|
41,115
|
|
|
(52,612,342
|
)
|
|
12,941,972
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
354,789
|
|
|
|
|
|
354,789
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,425,564
|
)
|
|
(9,425,564
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
65,446,587
|
|
|
(422
|
)
|
|
|
|
|
|
|
|
395,904
|
|
|
(62,037,906
|
)
|
|
3,871,197
|
|
Conversion of preferred to common stock
|
|
|
(5,653
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock warrants issued in conjunction with convertible notes
payable
|
|
|
142,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
142,500
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,175
|
|
|
|
|
|
10,175
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,286,100
|
)
|
|
(3,286,100
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
65,583,434
|
|
|
(422
|
)
|
|
|
|
|
|
|
|
406,079
|
|
|
(65,324,006
|
)
|
|
737,772
|
|
Exercise of warrants
|
|
|
47,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,391
|
|
Conversion of bridge notes to common stock
|
|
|
943,330
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
973,275
|
|
Private placement of common stock
|
|
|
2,737,190
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,777,857
|
|
Issuance of warrants
|
|
|
115,466
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,466
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,739
|
|
|
|
|
|
20,739
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,457,908
|
)
|
|
(3,457,908
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
$
|
69,426,457
|
|
$
|
(422
|
)
|
$
|
|
|
$
|
|
|
$
|
426,818
|
|
$
|
(68,781,914
|
)
|
$
|
1,215,592
|
|
Private placement of common stock
|
|
|
7,449,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,550,822
|
|
Issuance of warrants
|
|
|
435,705
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
435,705
|
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,864
|
|
|
|
|
|
28,864
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,703,768
|
)
|
|
(3,703,768
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
$
|
77,311,610
|
|
$
|
(422
|
)
|
$
|
|
|
$
|
|
|
$
|
455,682
|
|
$
|
(72,485,682
|
)
|
$
|
5,527,215
|
|
F-6
Index
AVAX Technologies, Inc.
and Subsidiaries
(a
development stage company)
Consolidated Statements
of Stockholders Equity (Deficit) (continued
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
36,750
|
|
$
|
367
|
|
|
61,414,998
|
|
$
|
245,660
|
|
Stock based compensation
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
36,750
|
|
$
|
367
|
|
|
61,414,998
|
|
$
|
245,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[TABLE CONTINUES]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
Paid-In
Capital
|
|
Subscription
Receivable
|
|
Deferred
Compensation
|
|
Unrealized
Loss on
Marketable
Securities
|
|
Accumulated
Other
Comprehensive
Income
|
|
Deficit
Accumulated
During the
Development
Stage
|
|
Total
Stockholders
Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
$
|
77,311,610
|
|
$
|
(422
|
)
|
$
|
|
|
$
|
|
|
$
|
455,682
|
|
$
|
(72,485,682
|
)
|
$
|
5,527,215
|
|
Stock based compensation
expense
|
|
|
148,548
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
148,548
|
|
Foreign currency translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,535
|
|
|
|
|
|
23,535
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,355,500
|
)
|
|
(5,355,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
$
|
77,460,158
|
|
$
|
(422
|
)
|
$
|
|
|
$
|
|
|
$
|
479,217
|
|
$
|
(77,841,182
|
)
|
$
|
343,798
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-7
Index
AVAX Technologies, Inc.
and Subsidiaries
(a development stage company)
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
January 12, 1990
(Incorporation) to
December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
Year ended
December 31
|
|
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,355,500
|
)
|
$
|
(3,703,768
|
)
|
$
|
(77,841,182
|
)
|
Adjustments
to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
290,434
|
|
|
315,039
|
|
|
4,783,722
|
|
Amortization of discount on convertible
notes payable
|
|
|
|
|
|
|
|
|
142,500
|
|
Extraordinary gain related to negative
goodwill on consolidated subsidiary
|
|
|
|
|
|
|
|
|
(902,900
|
)
|
Cumulative effect of change in accounting
|
|
|
|
|
|
|
|
|
(186,295
|
)
|
Amortization of deferred gain on joint
venture
|
|
|
|
|
|
|
|
|
(1,805,800
|
)
|
Equity in net loss of joint venture
|
|
|
|
|
|
|
|
|
1,703,763
|
|
Employee Stock Option Expense
|
|
|
148,548
|
|
|
|
|
|
148,548
|
|
Minority interest in net loss of
consolidated subsidiary
|
|
|
|
|
|
|
|
|
(80,427
|
)
|
Acquired in-process research and
development charge
|
|
|
|
|
|
|
|
|
4,420,824
|
|
Write down of acquired intellectual
property and other intangibles
|
|
|
|
|
|
|
|
|
3,416,091
|
|
Compensatory stock issue
|
|
|
|
|
|
|
|
|
25,000
|
|
Gain on sale of the Product
|
|
|
|
|
|
|
|
|
(1,951,000
|
)
|
Gain on sale of intellectual property
|
|
|
|
|
|
|
|
|
(787
|
)
|
Accretion of interest on common stock
receivable
|
|
|
|
|
|
|
|
|
(449,000
|
)
|
Accretion of interest on amount payable to
preferred stockholders and Former Officer
|
|
|
|
|
|
|
|
|
449,000
|
|
Loss on sale of furniture and equipment
|
|
|
|
|
|
|
|
|
246,254
|
|
Issuance of common stock or warrants for
services
|
|
|
|
|
|
|
|
|
423,289
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(119,980
|
)
|
|
(16,306
|
)
|
|
(84,197
|
)
|
Inventory
|
|
|
3,286
|
|
|
(1,090
|
)
|
|
30,667
|
|
Prepaid expenses and other current assets
|
|
|
74,016
|
|
|
45,259
|
|
|
(33,682
|
)
|
Research and development tax credit
receivable
|
|
|
81,087
|
|
|
146,582
|
|
|
320,488
|
|
Accounts payable and accrued liabilities
|
|
|
731,967
|
|
|
(377,463
|
)
|
|
1,060,627
|
|
Deferred revenue
|
|
|
52,295
|
|
|
(118,665
|
)
|
|
150,307
|
|
Amount payable to Former Officer
|
|
|
|
|
|
|
|
|
80,522
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
used in operating activities
|
|
$
|
(4,093,847
|
)
|
$
|
(3,710,412
|
)
|
$
|
(65,933,668
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
Purchases of
marketable securities
|
|
|
|
|
|
|
|
|
(351,973,210
|
)
|
Proceeds
from sale of marketable securities
|
|
|
|
|
|
|
|
|
344,856,738
|
|
Proceeds
from sale of short-term investments
|
|
|
|
|
|
|
|
|
7,116,472
|
|
Purchases of
furniture and equipment
|
|
|
(40,307
|
)
|
|
(292,004
|
)
|
|
(3,602,663
|
)
|
Proceeds
from sale of furniture and equipment
|
|
|
|
|
|
|
|
|
51,119
|
|
Cash
acquired in acquisition of control of joint venture
|
|
|
|
|
|
|
|
|
991,634
|
|
Organization
costs incurred
|
|
|
|
|
|
|
|
|
(622,755
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
used in investing activities
|
|
$
|
(40,307
|
)
|
$
|
(292,004
|
)
|
$
|
(3,182,665
|
)
|
F-8
Index
AVAX Technologies, Inc.
and Subsidiaries
(a development stage company)
Consolidated Statements
of Cash Flows (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
from
January 12, 1990
(Incorporation)
to
December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
December 31
|
|
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of notes payable to
related party
|
|
$
|
|
|
$
|
|
|
$
|
957,557
|
|
Principal payments on notes payable to
related party
|
|
|
|
|
|
|
|
|
(802,000
|
)
|
Proceeds from loans payable and the related
issuance of warrants
|
|
|
|
|
|
|
|
|
2,314,000
|
|
Principal payments on loans payable
|
|
|
|
|
|
|
|
|
(1,389,000
|
)
|
Payments for fractional shares from reverse
splits and preferred stock conversions
|
|
|
|
|
|
|
|
|
(76
|
)
|
Financing costs incurred
|
|
|
|
|
|
|
|
|
(90,000
|
)
|
Shareholder capital contribution
|
|
|
|
|
|
|
|
|
93,637
|
|
Payments received on subscription
receivable
|
|
|
|
|
|
|
|
|
4,542
|
|
Proceeds received from exercise of stock
warrants
|
|
|
|
|
|
|
|
|
76,892
|
|
Elimination of consolidated accounting
treatment for joint venture
|
|
|
|
|
|
|
|
|
(2,511,701
|
)
|
Capital contribution through sale of
interest in consolidated subsidiary
|
|
|
|
|
|
|
|
|
2,624,000
|
|
Net proceeds received from issuance of
preferred and common stock
|
|
|
|
|
|
7,986,527
|
|
|
68,852,491
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
7,986,527
|
|
|
70,130,342
|
|
|
Effect of exchange rate changes on cash
|
|
|
45,574
|
|
|
28,278
|
|
|
470,561
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash
|
|
|
(4,088,580
|
)
|
|
4,012,389
|
|
|
1,484,570
|
|
Cash at beginning of period
|
|
|
5,573,150
|
|
|
1,560,761
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at end of period
|
|
$
|
1,484,570
|
|
$
|
5,573,150
|
|
$
|
1,484,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
Interest Paid
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash activity:
|
|
|
|
|
|
|
|
|
|
|
Issuance of restricted stock compensation
|
|
$
|
|
|
$
|
|
|
$
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock warrants issued with
convertible notes
|
|
$
|
|
|
$
|
|
|
$
|
142,500
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of bridge loan into common
stock
|
|
$
|
|
|
$
|
|
|
$
|
950,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of interest with common stock
|
|
$
|
|
|
$
|
|
|
$
|
23,275
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes.
F-9
Index
N
otes
to Consolidated Financial Statements
December 31, 2006
and 2005
1. Description
of Business and Significant Accounting Policies
Description of
Business
AVAX
Technologies, Inc. and its subsidiaries (the Company) is a development stage
biopharmaceutical company.
In November
1995, the Company sold its leading product under development, an
over-the-counter nutritional, dietary, medicinal and/or elixorative food
supplement or drug and all of the related patents and other intellectual
property. The agreement was for $2.4 million in shares of common stock of
Interneuron Pharmaceuticals, Inc. (IPI), a public company, the parent of the
purchaser of the Product (the Stock). Certain common stockholders of the
Company were also common stockholders of IPI. Pursuant to the terms of the
agreement, the purchase price, payable in two equal installments in December
1996 and 1997, was fixed, and the number of shares of the Stock would vary
depending on the quoted market price of the Stock at such time. Because the Stock
was receivable in two equal annual installments, the gain from the sale of the
Product, $1,951,000, was calculated by discounting the value of the Stock
receivable using a discount rate of 15%.
Also in
November 1995, the Company entered into a license agreement with Thomas
Jefferson University (TJU) to develop, commercially manufacture and sell
products embodying immunotherapeutic vaccines for the treatment of malignant
melanoma and other cancers (the Invention)
(see
Note
2
).
In December
1996, the Company entered into a license agreement with Rutgers University
(Rutgers) to develop, commercially manufacture and sell products embodying a
series of compounds for the treatment of cancer and infectious diseases. During
2004 the Company and Rutgers agreed to cancel the license agreement and all of
the Companys obligations associated with the license agreement
(see Note 2)
.
In February
1997, the Company entered into a license agreement with Texas A&M to
develop, commercially manufacture and sell products embodying a series of
compounds for the treatment of cancer (the Texas A&M Compounds)
(see
Note 2
).
In November
1999, the Company entered into a definitive joint venture agreement with
Australia Vaccine Technologies (AVT) (formerly Neptunus International Holdings
Limited), a pharmaceutical group in Australia, under the subsidiary name, AVAX
Holdings Australia Pty Limited (AVAX Holdings). Under the joint venture
agreement, AVAX Holdings, through its affiliated entities AVAX Australia Pty
Limited and AVAX Australia Manufacturing Pty Limited (the Joint Venture
Companies), was organized for the purpose of manufacturing and marketing M-Vax,
an immunotherapy for the post-surgical treatment of Stage 3 and 4 melanoma, in
Australia and New Zealand. In January 2002, the Joint Venture Companies
repurchased 90% of AVTs interest in the two joint venture companies resulting
in AVAX owning a 95% interest in the net equity of both joint venture
companies. The Company was seeking but was unable to obtain a timely
governmental reimbursement for the costs of treatment with the M-Vax in
Australia, and determined to discontinue operations in Australia in order to
focus the cash resources of the Company on its U.S. and European operations. In
September 2002, the Company announced that it would be discontinuing its
operations in Australia and in December 2002 the Company completed the
liquidation of its Australian subsidiary.
In August
2000, the Company completed its acquisition of GPH, S.A. (Holdings) and
Genopoietic S.A. (Genopoietic) each a French societe anonyme based in Paris,
France with principal its operating facility in Lyon, France. Holdings and
Genopoietic were organized in 1993 to develop gene therapy applications and
market gene therapy treatments for cancer. The Company has designated the Lyon, France operations facility as its
primary source facility for the production of vaccines to be used in clinical
trials. In addition, the Company currently performs contract manufacturing and
research activities at its facilities located in Lyon. The Companys December
31, 2006 consolidated balance sheet includes approximately $(17,398) in net
assets related to these subsidiaries.
The Companys
business is subject to significant risks consistent with biotechnology
companies that are developing products for human therapeutic use. These risks
include, but are not limited to, uncertainties regarding research and
development, access to capital, obtaining and enforcing patents, receiving
regulatory approval, and competition with other biotechnology and
pharmaceutical companies. The Company plans to continue to finance its
operations with a combination of equity and debt financing and, in the longer
term, revenues from product sales, if any. However, there can be no assurance
that it will successfully develop any product or, if it does, that the product
will generate any or sufficient revenues.
F-10
Index
Basis of Presentation
The
consolidated financial statements have been prepared assuming that the Company
will continue as a going concern. For the year ended December 31, 2006, the
Company incurred a net loss of $5,355,500 and a use of cash in operating
activities of $4,093,847. The Companys cash requirements were satisfied
through a private placement of common stock in April 2005
(see Note 4)
, maintaining balances in
accounts payable and accrued expenses on terms in excess of those afforded in
commercial practice and customer agreements and through the use of available
cash. However, the Company does not have sufficient resources to maintain its existing
plan of operations throughout 2007. These conditions raise substantial doubt
about the Companys ability to continue as a going concern. Management
anticipates that additional debt or equity financing will be required to fund
ongoing operations in 2007. The Company is currently negotiating to raise
additional capital or secure revenue sources to fund current operations.
However, there is no assurance that the Company will successfully obtain the
required capital or revenues or, if obtained, the amounts will be sufficient to
fund ongoing operations in 2007. The inability to secure additional capital
could have a material adverse effect on the Company, including the possibility
that the Company could have to cease operations.
Principles of
Consolidation
The
accompanying consolidated financial statements include the accounts of AVAX
Technologies, Inc., and its subsidiaries. All significant intercompany balances
and transactions have been eliminated.
Foreign Currency
Translation
Holdings and
Genopoietic use the Euro as their functional currency as required by the
European Union. The Australian Joint Venture Companies and AVAX Holdings used
the Australian Dollar as their functional currency prior to the discontinuance
of operations discussed above.
In accordance
with Statement of Financial Accounting Standards (SFAS) No. 52, Foreign
Currency Translation, the financial statements of these entities have been
translated into U.S. dollars, the functional currency of the Company and its
other wholly-owned subsidiaries and the reporting currency herein, for purposes
of consolidation.
Use of Estimates
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the U.S. requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
Revenue Recognition
The Companys
revenues are related to the provision of contract services and the sale of its
product, the AC Vaccine Technology, for the treatment of melanoma. Contract
service revenue is recognized in installments based upon the contractual
agreement entered into with clients
(see
Note 3)
. Product revenues represent fees received or payable to the
Company related to the manufacture and sale of the vaccine. Product revenue is
recognized when the vaccine is received by the hospital administering the
vaccine.
The Company records as deferred revenue amounts received in advance of
the provision of services in accordance with contracts or grants. Deferred
revenue consisted of $160,678 received from a grant for which the services had
not been provided as of December 31, 2006.
Accounts Receivable
Accounts
receivable are stated at the amount management expects to collect from
outstanding balances. Management provides for probable uncollectible accounts
through a charge to earnings and a credit to a valuation allowance based on its
assessment of the current status of individual accounts. Balances that are
still outstanding after management has used reasonable collection efforts are
written off through a charge to the valuation allowance and a credit to
accounts receivable. There was no valuation allowance at December 31, 2006. The
Company generally does not charge interest on accounts receivable.
Concentrations of
Credit Risk
Financial
instruments that potentially subject the Company to credit risk are principally
cash and accounts receivable. Cash consists of checking accounts, money market
accounts and a certificate of deposit. The Company places its cash with its
principal bank that is a high credit quality financial institution. Cash
deposits generally are in excess of the FDIC insurance limits. Credit limits,
ongoing credit evaluations, and account monitoring procedures are utilized to
minimize the risk of loss from accounts receivable. Collateral is generally not
required.
F-11
Index
Fair Value of Financial Instruments
The carrying
amount of accounts receivable, accounts payable and accrued liabilities are
considered to be representative of their respective fair values due to their
short-term nature.
Inventories
Inventories
are stated at the lower of cost, determined using the first-in, first-out
method, or market. The Companys inventories include raw materials and supplies
used in research and development activities.
Accrued Expenses
The Company provides a provision for accrued expenses based upon its
contractual obligation, as calculated by the Company, for all claims made for
payment to the Company.
Depreciation
Depreciation
is computed using the straight-line method over the estimated useful lives of
furniture and equipment, which range from three to ten years. Depreciation for
the Companys manufacturing facility and related equipment are computed using
the straight-line method over estimated useful lives of 5 to 10 years.
Leasehold improvements related to the building are being amortized using the
straight-line method over the actual life of the lease.
Goodwill
The Company adopted SFAS No. 142, Goodwill and Other Intangible
Assets on January 1, 2002. This accounting standard requires that
goodwill and indefinite lived assets no longer be amortized but instead be
tested at least annually for impairment and expensed against earnings when the
implied fair value of a reporting unit, including goodwill, is less than its
carrying amount. The Company performed its annual goodwill impairment test in
accordance with SFAS No. 142 and determined that the carrying amount of
goodwill was reasonable.
Prior to the adoption of SFAS No. 142, the company had recorded
cumulative amortization of $113,032. If SFAS No. 142 had been applied to
earlier periods the adjusted loss from continuing operations would be
$77,950,369 and the adjusted net loss would be $77,954,214.
Research and
Development Costs
Research and
development costs, including payments related to research and license
agreements, are expensed when incurred. Contractual research expenses are
recorded pursuant to the provisions of the contract under which the obligations
originate. Research and development costs include all costs incurred related to
the research and development, including manufacturing costs incurred, related
to the Companys research programs. The Company is required to produce its
products in compliance with current Good Manufacturing Practices, which
requires a minimum level of staffing, personnel and facilities testing and
maintenance. Based upon its current staffing level required to be in compliance
with cGMP, the Company has excess capacity. Utilizing this excess capacity,
revenue is generated through contract manufacturing engagements (see Note 3).
Costs for production of products will be capitalized and charged to cost of
goods sold only after the Company has received approval to market the drug by a
Regulatory Authority.
Stock-Based
Compensation
Effective
January 1, 2006, the Company has adopted SFAS 123R, Share-Based Payment.
SFAS 123R establishes standards for the accounting for transactions in
which an entity exchanges its equity instruments for goods or services and
requires that the compensation cost relating to share-based payment transactions
be recognized in financial statements, measured by the fair value of the equity
or liability instruments issued, adjusted for estimated forfeitures. We
transitioned to SFAS 123R using the modified-prospective method, under which
prior periods have not been revised for comparative purposes. The valuation
provisions of SFAS 123R apply to new grants and to grants that were outstanding
as of the effective date and are subsequently modified. Estimated compensation
for grants that were outstanding as of the effective date will be recognized
over the remaining service period using the compensation cost previously
estimated for our SFAS 123 pro forma disclosures. Recognized stock-based
compensation expense for the year ended December 31, 2006 includes compensation
expense for share-based payment awards granted prior to, but not yet vested as
of December 31, 2005, based on the grant date fair value estimated in
accordance with the pro forma provisions of SFAS 123 and compensation expense
for the share-based payment awards granted subsequent to December 31, 2005
based on the grant date fair value estimated in accordance with the provisions
of SFAS 123R.
F-12
Index
Prior to the adoption of
SFAS 123R, the Company applied the intrinsic-value-based method of accounting
prescribed by Accounting Principles Board Opinion (APB) 25, Accounting for
Stock Issued to Employees, and related interpretations, to account for its
fixed-plan stock options to employees. Under this method, compensation cost was
recorded only if the market price of the underlying stock on the date of grant
exceeded the exercise price. SFAS 123, Accounting for Stock-Based
Compensation, established accounting and disclosure requirements using a
fair-value-based method of accounting for stock-based employee compensation
plans. As permitted by SFAS 123, the Company elected to continue to apply the
intrinsic-value-based method of accounting described above, and adopted only
the disclosure requirements of SFAS 123, as amended by SFAS No. 148,
Accounting for Stock-Based Compensation, Transition and Disclosure. The
fair-value-based method used to determine historical pro forma amounts under
SFAS 123 was similar in most respects to the method used to determine
stock-based compensation expense under SFAS 123R. However, in its pro forma
disclosures, the Company accounted for option forfeitures as they occurred,
rather than based on estimates of future forfeitures.
For purposes
of pro forma disclosures, the estimated fair value of the options is amortized
to expense over the option vesting period. The effects of applying SFAS
No. 123 for pro forma disclosures are not likely to be representative of
the effects on reported net income or losses for future years. The Companys
pro forma information follows:
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
Net loss as reported
|
|
$
|
(5,355,500
|
)
|
$
|
(3,703,768
|
)
|
Stock based compensation expense as
reported
|
|
|
148,548
|
|
|
|
|
Stock based compensation expense under fair
value method
|
|
|
(148,548
|
)
|
|
(211,722
|
)
|
|
|
|
|
|
|
|
|
Pro forma net loss attributable to common
stockholders
|
|
$
|
(5,355,500
|
)
|
$
|
(3,915,490
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per share basic and
diluted
|
|
$
|
(0.09
|
)
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
Net loss per share, as reported basic and
diluted
|
|
$
|
(0.09
|
)
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
The Company maintains two
employee stock option plans, a director stock option plan and has issued
non-qualified stock options to an executive officer and a director outside of
the existing stock option plans, which non-plan option grants have been
approved by the Board of Directors and the stockholders of the Company. These
plans are more fully discussed in the Form 10-KSB filed for the year ended
December 31, 2006. In addition, the Company issues warrants to consultants at
the discretion of the Board of Directors of the Company. The Company accounts
for warrants granted to consultants in accordance with Emerging Issues Task
Force Issue 96-18, Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services. The Company determines the value of stock warrants utilizing the
Black-Scholes option-pricing model.
Compensation
costs for fixed awards with pro rata vesting are allocated to periods on the straight-line
basis. The estimated weighted average fair value of options granted was
calculated based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
Tweleve Months Ended
December 31, 2005
|
|
Twelve Months Ended
December 31, 2006
|
|
|
|
|
|
|
|
Expected
term (in years)
|
|
4.00
|
|
|
4.50
|
|
|
Volatility
|
|
95.0
|
%
|
|
79.4
|
%
|
|
Risk-free
interest rate
|
|
2.75
|
%
|
|
4.30
|
%
|
|
Expected
dividends
|
|
0
|
|
|
0
|
|
|
For the twelve
months ended December 31, 2006, compensation expense of $81,578 was charged to
administrative expenses and $66,970 was charged to research and development
expenses related to stock options outstanding and not vested. As of
December 31, 2006, total compensation cost related to non-vested stock
options not yet recognized was $255,572, which is expected to be allocated to expenses
over a weighted-average period of 14 months.
The fair value of option
grants is estimated at the date of grant using the Black-Scholes model.
F-13
Index
The following
table shows the options and warrants outstanding by strike price with the
average expected remaining term of the instruments at December 31, 2006.
|
|
|
|
|
|
|
|
|
Exercise Price Range
|
|
Options & Warrants
Outstanding
|
|
Weighted-Average
Remaining Term
|
|
Vested Options &
Warrants
|
|
Weighted-Average
Remaining Term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.0
- $0.04
|
|
31,250
|
|
0.33
|
|
31,250
|
|
0.33
|
|
|
|
|
|
|
|
|
|
$0.125
- $0.17
|
|
8,798,050
|
|
2.37
|
|
8,243,050
|
|
2.21
|
|
|
|
|
|
|
|
|
|
$0.29
- $0.47
|
|
15,620,240
|
|
3.35
|
|
14,233,943
|
|
3.14
|
|
|
|
|
|
|
|
|
|
$0.89
- $0.91
|
|
280,000
|
|
1.73
|
|
280,000
|
|
1.73
|
|
|
|
|
|
|
|
|
|
$2.47
- $3.375
|
|
265,000
|
|
1.66
|
|
265,000
|
|
1.66
|
|
|
|
|
|
|
|
|
|
$8.25
|
|
125,000
|
|
4.84
|
|
125,000
|
|
4.84
|
|
|
|
|
|
|
|
|
|
$8.813
|
|
50,000
|
|
0.44
|
|
50,000
|
|
0.44
|
|
|
|
|
|
|
|
|
|
|
|
25,169,540
|
|
|
|
23,228,243
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Per Share
Net loss per
share is based on net loss divided by the weighted average number of shares of
common stock outstanding during the respective periods. Diluted earnings per
share information is not presented, as the effects of stock options, warrants
and other convertible securities would be anti-dilutive for the periods
presented.
Recently Issued Accounting Standards
In February
2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities. SFAS No. 159
permits all entities to choose to elect, at specified election dates, to measure
eligible financial instruments at fair value. An entity shall report unrealized
gains and losses on items for which the fair value option has been elected in
earnings at each subsequent reporting date and recognize upfront costs and fees
related to those items in earnings as incurred and not deferred. SFAS No. 159
applies to fiscal years beginning after November 15, 2007, with early adoption
permitted for an entity that has also elected to apply the provisions of SFAS
No. 157, Fair Value Measurements. We are currently evaluating the impact, if
any, the adoption of SFAS No. 159 may have on our financial statements.
In September
2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin (SAB) No. 108, Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements. SAB No.
108 provides interpretive guidance on the consideration of the effects of prior
year misstatements in quantifying current year misstatements for the purpose of
a materiality assessment. SAB No. 108 is effective for fiscal years ending
after November 15, 2006. The Company has reviewed the guidance of SAB 108 and
has determined that the adoption of SAB No. 108 did not have any impact on our
financial statements.
In September
2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157
defines fair value, establishes a framework for measuring fair value in
accordance with accounting principles generally accepted in the United States
of America and expands disclosures about fair value measurements. SFAS No. 157
applies under other accounting pronouncements that require or permit fair value
measurements. Accordingly, this pronouncement does not require any new fair
value measurements. We are required to adopt SFAS No. 157 beginning January 1,
2008. We are currently evaluating the impact, if any, the adoption of SFAS No.
157 may have on our financial statements.
In September 2006, the FASB
issued SFAS No. 158, Employers Accounting for Defined Benefit Pension and
Other Postretirement Plans, an amendment of FASB Statements No. 87, 88, 106,
and 132(R). SFAS No. 158 requires an employer to recognize the over-funded or
under-funded status of a defined benefit postretirement plan (other than a
multiemployer plan) as an asset or liability in its statement of financial
position and to recognize changes in that funded status in the year in which
the changes occur through comprehensive income. In addition, with limited
exceptions, this pronouncement requires an employer to measure the funded
status of a plan as of the date of its year-end statement of financial
position. SFAS No. 158 is effective for fiscal years ending after
December 15, 2006. As we do not have any defined benefit pension plans or
other postretirement plans, the adoption of this standard did not have any impact on our financial statements.
F-14
Index
In July 2006,
the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for Uncertainty
in Income Taxes. FIN 48 prescribes detailed guidance for the financial statement
recognition, measurement and disclosure of uncertain tax positions recognized
in an enterprises financial statements in accordance with FASB Statement No.
109, Accounting for Income Taxes. Tax positions must meet a
more-likely-than-not recognition threshold at the effective date to be
recognized upon the adoption of FIN 48 and in subsequent periods. FIN 48 will
be effective for fiscal years beginning after December 15, 2006 and the
provisions of FIN 48 will be applied to all tax positions upon initial adoption
of the Interpretation. The cumulative effect of applying the provisions of this
Interpretation will be reported as an adjustment to the opening balance of
retained earnings for that fiscal year. As we have provided a full valuation
allowance to reserve for our net deferred tax assets at December 31, 2006, the
adoption of this standard will not have a material impact on our results of
operations, financial condition, or cash flows.
Effective
January 1, 2006, we adopted the fair value recognition provisions of
SFAS 123R, Share-Based Payment, using the modified prospective transition
method and therefore did not restate results for prior periods. Prior to
January 1, 2006 we accounted for share-based compensation arrangements in
accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees
and complied with the disclosure provisions of SFAS 123, Accounting for
Stock-Based Compensation. Under the modified prospective method, new awards are
valued and accounted for prospectively upon adoption. Outstanding prior awards
that are unvested as of January 1, 2006 are recognized as compensation cost
over the remaining requisite service periods, as prior periods may not be
restated. The adoption of SFAS 123R increased our expenses and reported net
loss for 2006 by $148,548.
2.
License and Research Agreements
In November
1995, the Company entered into an agreement with TJU for the exclusive
worldwide license to develop, manufacture and sell the Invention
(see Note 1)
. In consideration for the license
agreement, the Company paid cash of $10,000 and issued an aggregate of 458,243
shares of common stock to TJU and the scientific founder (the Scientist).
Under the
terms of the license agreement the Company is obligated to (i) pay certain
milestone payments as follows: $10,000 upon initiation of the first clinical
trial that is approved by the Food and Drug Administration (FDA) or
comparable international agency, $10,000 upon the first filing of a New Drug
Application (NDA) with the FDA or comparable international agency, and
$25,000 upon receipt by the Company of approval from the FDA or comparable
international agency to market products, (ii) enter into a research agreement
to fund a study to be performed by TJU for the development of the technology
related to the Invention (the Study) at approximately $220,000 per annum for
the first three years, and (iii) following the third year, spend an aggregate
of $500,000 per year (which includes costs incurred pursuant to the research
agreement plus other internal and external costs) on the development of the
Invention until commercialized in the U.S. If following the third year, the
Company files for U.S. marketing approval through a Company sponsored NDA, the
Company may elect to spend less than $500,000 per year on the development of
the Invention during the period of time the NDA is under review by the FDA.
During 2000, a payment of $25,000 was made to TJU pursuant to the license
agreement. In addition, the Company is obligated to pay royalties on its worldwide
net revenue derived from the Invention and a percentage of all revenues
received from sub-licensees of the Invention.
The research
agreement with TJU mentioned above was to continue until completion of the
study, although it is terminable, upon notice by either party to the other, at
any time. Expenses incurred related to research funding for TJU was $115,000
for the year ended December 31, 2004. The Company has maintained the
appropriate level of spending on the development of the invention in accordance
with the license agreement.
In December
1996, the Company entered into an agreement with Rutgers University to develop,
commercially manufacture and sell products embodying a series of compounds for
the treatment of cancer. During 2004, the Company agreed with Rutgers to cancel
the license agreement and all the Companys obligations associated with the
license agreement.
In February
1997, the Company licensed from The Texas A&M University System an issued
U.S. patent and certain U.S. and foreign patent applications relating to a
series of novel cancer-fighting anti-estrogen compounds that may be especially
effective against hormone-dependent tumors. The development of the
anti-estrogren compounds is no longer a significant part of the Companys plan
of operation. The Company has been notified by Texas A&M that Texas A&M
considers the Company to be in violation of the license agreement and that the
Companys rights under the license agreement have been revoked. The Company
disputes the contention by Texas A&M and the Company is attempting to
return the technology to the University.
F-15
Index
3. Contractual
Joint Manufacturing Alliance
In February
2004, the Company entered into a manufacturing alliance with OPISODIA, SAS, a
French pharmaceutical company (OPI) that provided approximately $1,500,000
(US) funding per year from OPI for its allocated share of the manufacturing
expenses for the combined French facilities of the Company and OPI for 2005,
which were under the management of Genopoietic, a French subsidiary. Pursuant
to the contract the total manufacturing expenses incurred are allocated to OPI
based upon a pre-determined allocation of the total number of personnel
available to work on the OPI contract. The expenses allocated to the OPI
contract do not represent additional costs incurred in performing work under
the OPI contract but instead represent ongoing research and development
expenses that are allocated to the contract pursuant to the negotiated
contractual terms. This expense allocation does not represent costs incurred by
the Company in performing the contract. The Company and OPI agreed to terminate
this agreement as of May 31, 2005. Revenues of $546,803 recognized from
the OPI contract for the year ended December 31, 2005.
4. Equity
Transactions
Common and Preferred
Stock
In May 1996,
the Companys authorized capital was increased to 50,000,000 shares of common
stock, par value $.004, and 5,000,000 shares (of which 2,500,000 shares were
designated as Series A preferred stock, 300,000 shares were designated as
Series B preferred stock and 120,000 shares were designated as Series C
preferred stock) of preferred stock, par value $.01. In June 1998, the
Companys authorized common stock, par value $.004, was decreased to 30,000,000
shares. In January 2004, the Companys authorized common stock, par value
$.004, was increased to 150,000,000 shares. As of June 2006, no shares of the
Series B preferred stock were issued or outstanding, and the Certificate of
Designation for the Series B preferred stock was cancelled.
At the second
closing of the private placement on June 11, 1996, the 1,287,500 shares of
Series A preferred stock were automatically converted to 321,875 shares of
common stock. Notwithstanding such conversion, holders of the Series A
preferred stock have received pro rata 95.85% of shares of common stock of IPI
associated with the sale of the Product (
see
Note 1
).
In March 2000,
the Company announced the conversion of all outstanding shares of Series B
Convertible preferred stock into fully paid nonassessable shares of common
stock. As of the conversion date there were 66,093 shares of Series B
Convertible Preferred Stock outstanding that were convertible into 1,724,152
shares of Common Stock.
On March 1,
1999, the Company authorized and consummated an offering of Series C
Convertible Preferred Stock (the Series C Offering) pursuant to which the
Company raised aggregate gross proceeds of approximately $10,130,000. In the
Series C Offering, the Company sold an aggregate of 101,300 shares of Series C
Preferred Stock combined with Class A Warrants to purchase an aggregate of
311,692 shares of Common Stock at an exercise price of $4.00 per share and
Class B Warrants to purchase an aggregate of 311,692 shares of Common Stock at
an exercise price of $4.50 per share. During 2000 2,462 of these Class A and
Class B warrants were exercised. The Series C Preferred Stock, the Class A
Warrants and the Class B Warrants were sold as a unit in the Series C Offering.
The Class A Warrants and Class B Warrants were exercisable until March 1, 2004.
The Series C
preferred stockholders are entitled to voting rights equivalent to the number
of common shares into which their preferred shares are convertible. The Series
C preferred stockholders are also entitled to receive, in preference to the
holders of common stock, an amount per preferred share of $100 plus any
declared but unpaid dividends.
Pursuant to
the terms of the private placement, each share of Series C preferred stock was
convertible at any time, in whole or in part, at the discretion of the holders,
into common stock at $3.25 per share.
In connection
with the private placement, the Company paid $845,261 in finders fees and
non-accountable expenses. Of this amount $709,100 was paid to Paramount in the
form of a finders fee.
During 2000
holders of 14,550 shares the Series C Preferred stock converted these shares
into 650,931 fully paid nonassessable shares of common stock. During 2001
holders of 50,000 shares of the Series C Preferred stock converted these shares
into 1,538,450 fully paid nonassessable shares of common stock. The 36,750
shares of Series C preferred stock, outstanding at December 31, 2006, is
convertible into 1,130,755 shares of common stock excluding the effect of any
fractional shares.
In March 2000,
the Company completed a $25,137,000 private placement with institutional
investors. The Company sold an aggregate of 2,259,494 newly issued shares of
common stock, and issued warrants to purchase an additional 225,951 shares of
common stock at an exercise price of $12.79 per share, for an aggregate warrant
exercise price of $2,890,817. The warrants expired on
March 10, 2005.
F-16
Index
In connection
with services rendered in connection with the private placement, the Company
paid Gruntal & Co., L.L.C., who acted as the placement agent, a cash fee of
approximately $747,000. Other share issuance expenses amounted to approximately
$54,000.
Pursuant to a
prior agreement, Paramount was paid a fee due to the participation in the
private placement of certain investors previously introduced to the Company by
Paramount. As a result of this agreement, the Company paid Paramount a cash fee
of approximately $140,000.
On August 24,
2000, the Company completed its acquisition of GPH, S.A. (Holdings) and Genopoietic
S.A. (Genopoietic), each a French societe anonyme based in Paris, France. In
this transaction, 100% of the outstanding shares of both Holdings, which is the
majority shareholder of Genopoietic, and Genopoietic have been contributed to
the Company by the shareholders of those two entities in exchange for an
aggregate of 800,000 shares of the Companys common stock valued at $7,600,000
as of the acquisition date and $5,000 in notes payable. Of the 800,000 shares
issued to Professors David R. Klatzmann and Jean-Loup Salzmann (the primary
shareholders), 659,756 shares have been placed in escrow to secure their
indemnification obligations under the Contribution Agreement. In addition, the
Company incurred $621,397 in acquisition costs, which were capitalized as part
of the purchase price and allocated to the net assets acquired.
The Company
has notified Professors Klatzmann and Salzmann that they are in default of
their obligations under the Contribution Agreement and has put them on notice
that the escrow shares are being cancelled and will revert back to the Company
as treasury shares. As of the date of the financial statements, the shares have
not been formally cancelled.
On May 21,
2004, the Company closed the private placement of 10,166,167 shares of the
Companys common stock plus warrants to purchase 1,525,000 shares of common
stock at $0.35 per share (Series A Warrants) and warrants to purchase 1,525,000
shares of common stock at $0.39 per share (Series B Warrants). Gross proceeds
from the offering was approximately $3,050,000. In addition, the Company issued
warrants to its advisors relating to this placement to purchase 1,155,117
shares of common stock at warrant exercise prices ranges from $0.14 to $0.33
per share. These warrants were valued at $115,466 using the Black-Scholes
pricing model. Offering related expenses in connection with this placement
amounted to $272,143 of which $156,677 was paid in cash and the balance relates
to the warrants issued to the advisors.
On May 21,
2004, in compliance with the Note Purchase Agreements entered into in December,
2003, the Company converted the principal ($950,000) and interest ($23,275) on
the bridge notes into common stock at an exercise price of $0.13 per share
resulting in the issuance of 7,486,430 shares of the Companys common stock.
On April 5,
2005, the Company closed a private placement of 25,343,430 shares of common
stock at a purchase price of $0.34 per share with 12 accredited or
institutional investors. The Company received gross proceeds of approximately
$8,616,000. In connection with the private placement, the Company also issued
to the investors warrants to purchase 3,801,515 shares of common stock at a
warrant exercise price of $0.41 per share, and warrants to purchase 3,801,515
shares of common stock at a warrant exercise price of $0.48 per share. In
addition, the Company issued warrants to its advisors relating to this
fundraising to purchase 2,287,293 shares of common stock at a warrant exercise
price of $0.37 per share. These warrants were valued at $435,705 using the
Black-Scholes pricing model. Offering related expenses in connection with this
fundraising amounted to $1,065,945 of which $630,240 was paid in cash and the
balance relates to the warrants issued to the advisors.
Stock Options 1992
Stock Option Plan
In April 1992,
the Board of Directors approved the 1992 Stock Option Plan (the 1992 Plan),
which, as amended, authorized up to 437,500 shares of common stock for granting
both incentive and nonqualified stock options to employees, directors,
consultants and members of the scientific advisory board of the Company. The
1992 Plan was amended in June 1999, to increase the number of shares issuable
to 1,500,000. The 1992 Plan was further amended in June 2000, to increase the number
of shares issuable to 2,500,000. The exercise price and vesting period of the
options are determined by the Board of Directors at the date of grant. Options
may be granted up to 10 years after the 1992 Plans adoption date and generally
expire 7 years from the date of grant.
F-17
Index
The following
summarizes activity in the 1992 Plan:
|
|
|
|
|
|
|
N
UMBER OF
O
PTIONS
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
276,375
|
|
Canceled
|
|
|
(246,375
|
)
|
|
|
|
|
|
Balance at December 31, 1995, 1996 and 1997
|
|
|
30,000
|
|
Granted
|
|
|
600,000
|
|
|
|
|
|
|
Balance at December 31, 1998
|
|
|
630,000
|
|
Granted
|
|
|
955,397
|
|
Expired
|
|
|
(240,000
|
)
|
|
|
|
|
|
Balance at December 31, 1999
|
|
|
1,345,397
|
|
Granted
|
|
|
430,000
|
|
Expired
|
|
|
(13,430
|
)
|
Exercised
|
|
|
(7,955
|
)
|
|
|
|
|
|
Balance at December 31, 2000
|
|
|
1,754,012
|
|
Granted
|
|
|
1,039,696
|
|
Expired
|
|
|
(386,684
|
)
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
2,407,024
|
|
Expired
|
|
|
(567,365
|
)
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
1,839,659
|
|
Expired
|
|
|
(1,058,755
|
)
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
780,904
|
|
Expired
|
|
|
(1,621
|
)
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
779,283
|
|
Expired
|
|
|
(195,000
|
)
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
584,283
|
|
Expired
|
|
|
(353,889
|
)
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
230,394
|
|
|
|
|
|
|
Stock Options 2001
Stock Option Plan
In November
2001 the Board of Directors approved the 2001 Stock Option Plan (the 2001
Plan), subject to shareholder approval, authorizing up to 2,500,000 shares of
common stock for granting both incentive and nonqualified stock options to
employees, directors, consultants and members of the scientific advisory board
of the Company. The exercise price and vesting period of the options are
determined by the Board of Directors at the date of grant. Options may be
granted up to 10 years after the 2001 Plans adoption date and generally expire
10 years from the date of grant.
The following
summarizes activity in the 2001 Plan:
|
|
|
|
|
Granted
|
|
|
175,108
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
175,108
|
|
Expired
|
|
|
(59,435
|
)
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
115,673
|
|
Expired
|
|
|
(90,688
|
)
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
24,985
|
|
Granted
|
|
|
1,155,000
|
|
Expired
|
|
|
(379
|
)
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
1,179,606
|
|
Granted
|
|
|
873,250
|
|
Expired
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 & 2006
|
|
|
2,052,856
|
|
|
|
|
|
|
F-18
Index
Director Option Plan
In June 2000,
the Company adopted the 2000 Director Stock Option plan and authorized the plan
to issue up to 480,000 shares of common stock as compensation to the outside
directors of the Company for services to be received from the Directors. During
2000, each of the Companys six outside directors received options to purchase
40,000 shares of common stock, which vest quarterly at the rate 2,500 shares,
with the first vesting period being January 1, 2000. Pursuant to the plan documents
an additional 40,000 options per director were issued as of January 1, 2004,
vesting over a four-year period. Pursuant to a change in the plan an additional
30,000 options per director were issued on January 1, 2006, vesting over a
one-year period. The Company will obtain shareholder approval to increase the
authorized number of shares under the option plan.
The following
summarizes activity in the Director Option Plan:
|
|
|
|
|
Granted
|
|
|
240,000
|
|
|
|
|
|
|
Balance at December 31, 2001, 2002 & 2003
|
|
|
240,000
|
|
Granted
|
|
|
160,000
|
|
|
|
|
|
|
Balance at December 31, 2004 & 2005
|
|
|
400,000
|
|
Granted
|
|
|
120,000
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
520,000
|
|
|
|
|
|
|
The Company,
with the authorization of the board of directors, issues nonqualified stock
options to employees, directors, advisors, consultants and members of the
scientific advisory board of the Company. The exercise price, expiration date
and vesting period of the options are determined by the Board of Directors at the
date of grant.
The following
summarizes other stock option grants:
|
|
|
|
|
Granted
|
|
|
571,373
|
|
|
|
|
|
|
Balance at December 31, 1996
|
|
|
571,373
|
|
Granted
|
|
|
580,644
|
|
|
|
|
|
|
Balance at December 31, 1997
|
|
|
1,152,017
|
|
Granted
|
|
|
103,404
|
|
|
|
|
|
|
Balance at December 31, 1998
|
|
|
1,255,421
|
|
Granted
|
|
|
20,000
|
|
|
|
|
|
|
Balance at December 31, 1999
|
|
|
1,275,421
|
|
Granted
|
|
|
27,382
|
|
Exercised
|
|
|
(9,688
|
)
|
|
|
|
|
|
Balance at December 31, 2000
|
|
|
1,293,115
|
|
|
|
|
|
|
Issued
|
|
|
135,000
|
|
Expired
|
|
|
(280,000
|
)
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
1,148,115
|
|
Expired
|
|
|
(53,000
|
)
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
1,095,115
|
|
Expired
|
|
|
(501,685
|
)
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
593,430
|
|
Expired
|
|
|
(360,644
|
)
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
232,786
|
|
Granted
|
|
|
775,000
|
|
Expired
|
|
|
(71,000
|
)
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
936,786
|
|
Expired
|
|
|
(61,786
|
)
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
875,000
|
|
|
|
|
|
|
On June 7, 2005 the
Compensation Committee of the Board of Directors authorized the issuance of
options to purchase 500,000 and 275,000 shares of the Companys common stock to
Richard Rainey, President and John Prendergast, Chairman, respectively. The
exercise price of the options is $0.30 per share (the then current market
price) and the options have term of seven years through June 7, 2012.
F-19
Index
Warrants
The Company,
with the authorization of the board of directors issues warrants for the
purchase of common stock in conjunction with equity and debt offerings as well
as to consultants that assist the company in various financial or commercial
transactions. The exercise price, expiration date and vesting period of the
options are determined by the Board of Directors at the date of grant.
The following
summarizes warrant grants:
|
|
|
|
Granted
|
|
7,750
|
|
|
|
|
|
Balance at
December 31, 1993, 1994
|
|
7,750
|
|
Granted
|
|
165,612
|
|
|
|
|
|
Balance at
December 31, 1995
|
|
173,362
|
|
Granted
|
|
931,152
|
|
Exercised
|
|
(156,250
|
)
|
|
|
|
|
Balance at
December 31, 1996
|
|
948,264
|
|
Granted
|
|
418,569
|
|
Exercised
|
|
(88,769
|
)
|
Expired
|
|
(25,000
|
)
|
|
|
|
|
Balance at
December 31, 1997
|
|
1,253,064
|
|
Granted
|
|
115,000
|
|
Expired
|
|
(7,750
|
)
|
|
|
|
|
Balance at
December 31, 1998
|
|
1,360,314
|
|
Granted
|
|
997,801
|
|
Exercised
|
|
(75,000
|
)
|
|
|
|
|
Balance at
December 31, 1999
|
|
2,283,115
|
|
Granted
|
|
444,710
|
|
Exercised
|
|
(27,588
|
)
|
Expired
|
|
(250,654
|
)
|
|
|
|
|
Balance at
December 31, 2000, 2001 & 2002
|
|
2,449,583
|
|
Granted
|
|
7,308,000
|
|
Expired
|
|
(84,000
|
)
|
|
|
|
|
Balance at
December 31, 2003
|
|
9,673,583
|
|
Granted
|
|
4,371,783
|
|
Exercised
|
|
(338,400
|
)
|
Expired
|
|
(1,110,185
|
)
|
|
|
|
|
Balance at
December 31, 2004
|
|
12,596,781
|
|
Granted
|
|
9,723,657
|
|
Expired
|
|
(444,710
|
)
|
|
|
|
|
Balance at
December 31, 2005
|
|
21,875,728
|
|
|
|
|
|
Granted
|
|
270,000
|
|
Expired
|
|
(654,438
|
)
|
|
|
|
|
Balance at
December 31, 2006
|
|
21,491,290
|
|
|
|
|
|
Authorized but
unissued shares of common stock were reserved for issuance at December 31,
2006 as follows:
|
|
|
|
Series C
convertible preferred stock
|
|
1,130,755
|
|
1992 Stock
option plan
|
|
2,500,000
|
|
2001 Stock
option plan
|
|
2,500,000
|
|
2000
Directors option plan
|
|
520,000
|
|
Non plan
options
|
|
875,000
|
|
Warrants to
purchase common stock
|
|
3,868,660
|
|
Warrants to purchase common stock pursuant
to the 2003 Bridge Financing
|
|
6,969,600
|
|
2004 Series
A Warrants
|
|
1,525,000
|
|
2004 Series
B Warrants
|
|
1,525,000
|
|
2005 Series
A Warrants
|
|
3,801,515
|
|
2005 Series
B Warrants
|
|
3,801,515
|
|
|
|
|
|
|
|
29,017,045
|
|
|
|
|
|
F-20
Index
A summary of
applicable stock option and warrant activity and related information for the
years ended December 31, 2006 and 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Options and
Warrants
|
|
Weighted-
Average
Exercise
Price
|
|
Options and
Warrants
|
|
Weighted-
Average
Exercise
Price
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at beginning of year
|
|
|
25,849,652
|
|
$
|
0.53
|
|
|
15,188,456
|
|
$
|
0.99
|
|
Granted
|
|
|
390,000
|
|
|
0.32
|
|
|
11,371,906
|
|
|
0.41
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(1,070,112
|
)
|
|
3.71
|
|
|
(710,710
|
)
|
|
8.32
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at end of year
|
|
|
25,169,540
|
|
$
|
0.39
|
|
|
25,849,652
|
|
$
|
0.53
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at end of year
|
|
|
24,580,321
|
|
$
|
0.56
|
|
|
23,610,558
|
|
$
|
0.56
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
prices for options and warrants outstanding range from $0.13 to $8.24. The
option and warrant contracts expire at various times through January 2016. The
weighted-average grant date fair value of options granted during the years 2006
and 2005 were $0.18 and $0.20, respectively.
ANVAR Advances
The Companys
French subsidiary receives financial support from a French governmental agency
(ANVAR). These advances, which are subject to conditions specifying that
non-compliance with such conditions could result in the forfeiture of all or a
portion of the future amounts to be received, as well as the repayment of all
or a portion of amounts received to date. If certain products are
commercialized, the December 31, 2006 balance of $362,109 (1,800,000 French
Francs) is repayable based on an annual royalty equal to 47% of the revenue
related to the project. As such, the total amount of advances received are
recorded as a liability in the accompanying consolidated balance sheet. In case
of failure or partial success, as defined in the agreement, $75,121 (400,000
French Francs) is payable. The due date for the obligation has past but the
grantor agency has not demanded repayment of the obligation. Due to the
uncertainty regarding the amount that will be required to be returned to ANVAR,
the Company maintains the full amount of the obligation as a current liability.
At December
31, 2006, the Company has net operating loss carryforwards of $75,911,918 for
income tax purposes. U. S. and state tax losses of $67,995,650 expire in
varying amounts between 2007 and 2024, if not utilized. Foreign losses of
$7,916,268 continue indefinitely and may be applied against future income.
Deferred
income taxes reflect the net tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of the
Companys deferred tax assets and liabilities for federal income tax purposes
are as follows:
|
|
|
|
|
|
|
December 31,
2006
|
|
|
|
|
|
|
|
|
|
Deferred tax
assets:
|
|
|
|
|
Net operating losses
|
|
$
|
29,150,000
|
|
Deferred compensation
|
|
|
413,000
|
|
Depreciation
|
|
|
283,000
|
|
Other
|
|
|
1,000
|
|
|
|
|
|
|
Total
deferred tax assets
|
|
$
|
29,847,000
|
|
Valuation
allowance
|
|
|
(29,847,000
|
)
|
|
|
|
|
|
Net deferred
tax assets
|
|
$
|
|
|
|
|
|
|
|
F-21
Index
The valuation
allowance at December 31, 2005 was $27,793,000.
Under Section
382 of the Tax Reform Act of 1986, the Companys net operating loss
carryforward could be subject to an annual limitation if it should be
determined that a change in ownership of more than 50% of the value of the
Companys stock occurred over a three-year period.
The following
summary reconciles the income tax benefit at the federal statutory rate with
the actual income tax provision (benefit):
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes
(benefit) at statutory rate
|
|
$
|
(1,819,000
|
)
|
$
|
(1,259,000
|
)
|
State income
taxes, net of federal benefit
|
|
|
(235,000
|
)
|
|
(163,000
|
)
|
Change in the
valuation allowance
|
|
|
2,054,000
|
|
|
1,422,000
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
provision (benefit)
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
8.
|
Commitments and Contingencies
|
Leases
In December
1997, the Company entered into a 10-year lease agreement for manufacturing
facility space. The first months rent was payable upon signing of the lease
along with a security deposit equivalent to two months rental. This lease is
secured by a one-year irrevocable standby letter of credit whereby the lessor
is the named beneficiary. This letter of credit automatically renews each
December and will be reduced by the amortized reduction of the landlord
investment each year. A certificate of deposit in the amount of $57,049 at
December 31, 2006 is held by the bank as collateral for the letter of credit.
In July 2000,
the Company entered into a 9-year lease agreement for manufacturing and
research space in Lyon, France. The lease may be cancelled by the Company after
July 2009.
In November of
2001, the Company entered into a three-year lease agreement for office space.
This lease expired during November, 2004 and was not renewed.
Rent expense
under these agreements was approximately $343,043 and $331,832 for the years
ended December 31, 2006 and 2005, respectively. Future minimum rental
payments required under non-cancelable operating leases with initial or
recurring terms of more than one year as of December 31, 2006 are $329,189 in
2007, $176,793 in 2008 and $88,397 in 2009.
Consulting Agreements
Effective in
June 1996, the Company entered into consulting agreements with the Scientist
that ran through May 2003, with options to extend on a month to month basis.
Annual consulting fees payable pursuant to the agreement with the Scientist was
$48,000
(see Note 1)
. The
agreement was terminated in November 2004 when the Scientist joined the Company
as a full time employee.
Other
The Company is
subject to various legal proceedings and claims that arise in the ordinary
course of its business. Management believes, based in part upon the opinions of
counsel, that the ultimate liability with respect to these actions will not
have a material adverse effect on the Companys financial position.
F-22
Index
|
|
9.
|
Property, Plant and Equipment
|
The following
shows the composition of the assets included in property, plant and equipment
at December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
|
|
Accumulated
Depreciation
|
|
Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Office
furniture and equipment
|
|
$
|
312,452
|
|
$
|
287,677
|
|
$
|
24,785
|
|
Manufacturing
facility and related equipment
|
|
|
3,655,476
|
|
|
2,801,020
|
|
|
854,456
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,967,928
|
|
$
|
3,088,687
|
|
$
|
879,241
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
expense was $290,434 and $315,039 for the years ended December 31, 2006 and
2005, respectively.
|
|
10.
|
Employee Benefit Plan
|
During 1996, the
Company established a discretionary 401(k) plan for all U.S. employees over the
age of 21. Employee contributions are subject to normal 401(k) plan
limitations. The Company was not required to make a contribution in 2006 or
2005.
|
|
11.
|
Related Party Transactions
|
During 2006
and 2005 the Company paid additional cash compensation of $126,000 per year to
one of its Board Members who took a more active role in assisting existing
management of the Company. It is anticipated that this role will continue until
such time as additional management personnel are hired. The compensation was
voted upon and approved by the Compensation Committee of the Board of
Directors.
The Company
receives administrative support services in the form of office space and
administrative services from a partnership in which Richard Rainey, President,
is a partner. The Company is not charged for these services and does not record
any expenses associated with the services due to the limited value of these
services.
On August 1,
2006, the stockholders of the Company approved an increase in the authorized
common stock from 150,000,000 to 500,000,000. Effective February 20, 2007, the
Company increased the aggregate number of shares that the Company has authority
to issue to 505,000,000, of which 5,000,000, par value $0.01 per share, are
designated as preferred stock, and 500,000,000, par value $0.004 per share, are
designated common stock.
On April 13, 2007, the Company
closed a private placement of 80,060,000 shares of common stock at a purchase
price of $0.125 per share with 25 accredited and institutional investors. The
Company received gross proceeds of approximately $10,007,500, and incurred
offering-related expenses of $589,350 payable to advisors related to the
fundraising. In connection with the private placement, the Company also issued
to the investors warrants to purchase 80,060,000 shares of common stock at a
warrant exercise price of $0.15 per share. All warrants issued in this private
placement expire on April 13, 2012.
F-23
Index
AVAX Technologies,
Inc. and Subsidiaries
(a development stage company)
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
|
December
31,
2006
|
|
September
30,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
1,484,570
|
|
$
|
7,683,572
|
|
Accounts receivable
|
|
|
220,161
|
|
|
70,341
|
|
Inventory
|
|
|
10,508
|
|
|
14,498
|
|
VAT receivable
|
|
|
50,937
|
|
|
91,569
|
|
Prepaid expenses and other current assets
|
|
|
210,343
|
|
|
125,101
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,976,519
|
|
|
7,985,081
|
|
Property, plant and equipment, at cost
|
|
|
3,967,928
|
|
|
4,202,363
|
|
Less accumulated depreciation
|
|
|
3,088,687
|
|
|
3,392,627
|
|
|
|
|
|
|
|
|
|
Net property, plant and equipment
|
|
|
879,241
|
|
|
809,736
|
|
Goodwill
|
|
|
188,387
|
|
|
188,387
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,044,147
|
|
$
|
8,983,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
1,460,644
|
|
$
|
2,776,628
|
|
Accrued and withheld payroll taxes and
liabilities
|
|
|
716,918
|
|
|
303,884
|
|
Deferred revenue
|
|
|
160,678
|
|
|
463,902
|
|
ANVAR advances
|
|
|
362,109
|
|
|
390,181
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,700,349
|
|
|
3,934,595
|
|
Stockholders equity
:
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value:
|
|
|
|
|
|
|
|
Authorized shares 5,000,000, consisting
of Series C 120,000 shares
|
|
|
|
|
|
|
|
Series C convertible preferred stock:
|
|
|
|
|
|
|
|
Issued and outstanding shares 36,700 at
December 31, 2006 and 33,500 at September 30, 2007 (liquidation preference -
$3,670,000 and $3,500,000)
|
|
|
367
|
|
|
335
|
|
Common stock, $.004 par value:
|
|
|
|
|
|
|
|
Authorized shares 500,000,000
|
|
|
|
|
|
|
|
Issued and
outstanding shares 61,414,998 at December 31, 2006 and 141,574,997 at
September 30, 2007
|
|
|
245,660
|
|
|
566,300
|
|
Additional paid-in capital
|
|
|
77,460,158
|
|
|
86,602,421
|
|
Subscription receivable
|
|
|
(422
|
)
|
|
(422
|
)
|
Accumulated other comprehensive income
|
|
|
479,217
|
|
|
434,884
|
|
Deficit accumulated during the development
stage
|
|
|
(77,841,182
|
)
|
|
(82,554,909
|
)
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
343,798
|
|
|
5,048,609
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
3,044,147
|
|
$
|
8,983,204
|
|
|
|
|
|
|
|
|
|
F-24
Index
AVAX Technologies,
Inc. and Subsidiaries
(a
development stage company)
Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period From
January 12, 1990
(Incorporation)
To Sept. 30,
2007
|
|
|
|
Three
Months Ended September 30,
|
|
Nine
Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
2007
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain from sale of the Product
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
1,951,000
|
|
Product and contract service revenue
|
|
|
96,178
|
|
|
95,877
|
|
|
522,711
|
|
|
299,193
|
|
|
6,704,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
96,178
|
|
|
95,877
|
|
|
522,711
|
|
|
299,193
|
|
|
8,655,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,004,341
|
|
|
1,350,907
|
|
|
3,162,049
|
|
|
3,402,404
|
|
|
51,054,172
|
|
Acquired in process research and
development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,420,824
|
|
Write down of acquired intellectual
property and other intangibles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,416,091
|
|
Amortization of acquired intangibles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
715,872
|
|
Selling, general and administrative
|
|
|
495,368
|
|
|
719,286
|
|
|
1,442,897
|
|
|
1,813,479
|
|
|
37,058,568
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss
|
|
|
(1,403,531
|
)
|
|
(1,974,316
|
)
|
|
(4,082,235
|
)
|
|
(4,916,690
|
)
|
|
(88,010,512
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
32,325
|
|
|
108,085
|
|
|
121,804
|
|
|
202,963
|
|
|
6,128,322
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(812,067
|
)
|
Other, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
32,325
|
|
|
108,085
|
|
|
121,804
|
|
|
202,963
|
|
|
5,459,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(1,371,206
|
)
|
|
(1,866,231
|
)
|
|
(3,960,431
|
)
|
|
(4,713,727
|
)
|
|
(82,551,064
|
)
|
Loss from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,845
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,371,206
|
)
|
|
(1,866,231
|
)
|
|
(3,960,431
|
)
|
|
(4,713,727
|
)
|
|
(82,554,909
|
)
|
Amount payable for liquidation preference
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,870,033
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common
stockholders
|
|
$
|
(1,371,206
|
)
|
$
|
(1,866,231
|
)
|
$
|
(3,960,431
|
)
|
$
|
(4,713,727
|
)
|
$
|
(84,424,942
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share basic and diluted
|
|
$
|
(.02
|
)
|
$
|
(.01
|
)
|
$
|
(.06
|
)
|
$
|
(.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding
|
|
|
61,414,998
|
|
|
141,496,737
|
|
|
61,414,998
|
|
|
111,276,536
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,371,206
|
)
|
$
|
(1,866,231
|
)
|
$
|
(3,960,431
|
)
|
$
|
(4,713,727
|
)
|
|
|
|
Foreign currency translation gain (loss)
|
|
|
(4,561
|
)
|
|
(5,963
|
)
|
|
11,603
|
|
|
(44,333
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net comprehensive loss
|
|
$
|
(1,375,767
|
)
|
$
|
(1,872,194
|
)
|
$
|
(3,948,828
|
)
|
$
|
(4,758,060
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-25
Index
AVAX Technologies,
Inc. and Subsidiaries
(a development stage company)
Consolidated
Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
from January
12, 1990
(Incorporation)
To Sept. 30,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,960,431
|
)
|
$
|
(4,713,727
|
)
|
$
|
(82,554,909
|
)
|
Adjustments to reconcile net loss to net
cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
221,852
|
|
|
222,593
|
|
|
5,006,315
|
|
Stock based compensation expense
|
|
|
105,818
|
|
|
144,511
|
|
|
293,059
|
|
Amortization of discount on convertible
notes payable
|
|
|
|
|
|
|
|
|
142,500
|
|
Amortization of deferred gain on joint
venture
|
|
|
|
|
|
|
|
|
(1,805,800
|
)
|
Equity in net loss of joint venture
|
|
|
|
|
|
|
|
|
1,703,763
|
|
Extraordinary gain related to negative
goodwill on consolidated subsidiary
|
|
|
|
|
|
|
|
|
(902,900
|
)
|
Cumulative effect of change in accounting
|
|
|
|
|
|
|
|
|
(186,295
|
)
|
Compensatory stock issue
|
|
|
|
|
|
|
|
|
25,000
|
|
Minority interest in net loss of
consolidated subsidiary
|
|
|
|
|
|
|
|
|
(80,427
|
)
|
Acquired in-process research and
development charge
|
|
|
|
|
|
|
|
|
4,420,824
|
|
Write down of acquired intellectual
property and other intangibles
|
|
|
|
|
|
|
|
|
3,416,091
|
|
Gain from sale of the Product
|
|
|
|
|
|
|
|
|
(1,951,000
|
)
|
Gain on sale of intellectual property
|
|
|
|
|
|
|
|
|
(787
|
)
|
Accretion of interest on common stock
receivable
|
|
|
|
|
|
|
|
|
(449,000
|
)
|
Accretion of interest on amount payable to
preferred stockholders and former officer
|
|
|
|
|
|
|
|
|
449,000
|
|
Loss (Gain) on sale or abandonment of
furniture and equipment
|
|
|
|
|
|
|
|
|
246,254
|
|
Issuance of common stock or warrants for
services
|
|
|
|
|
|
|
|
|
423,289
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(27,386
|
)
|
|
154,881
|
|
|
70,684
|
|
Inventory
|
|
|
(422
|
)
|
|
(2,947
|
)
|
|
27,720
|
|
Prepaid expenses and other current assets
|
|
|
123,716
|
|
|
56,094
|
|
|
22,412
|
|
Accounts payable and accrued liabilities
|
|
|
293,017
|
|
|
881,576
|
|
|
1,942,203
|
|
Deferred revenue
|
|
|
52,294
|
|
|
287,835
|
|
|
438,142
|
|
Research and development tax credit
receivable
|
|
|
81,087
|
|
|
|
|
|
320,488
|
|
Amount payable to former officer
|
|
|
|
|
|
|
|
|
80,522
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,110,455
|
)
|
|
(2,969,184
|
)
|
|
(68,902,852
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
Purchase of marketable securities and
short-term investments
|
|
|
|
|
|
|
|
|
(351,973,210
|
)
|
Proceeds from sale of marketable securities
|
|
|
|
|
|
|
|
|
344,856,738
|
|
Proceeds
from sale of short-term investments
|
|
|
|
|
|
|
|
|
7,116,472
|
|
Purchases of furniture and equipment
|
|
|
(37,436
|
)
|
|
(123,706
|
)
|
|
(3,726,369
|
)
|
Proceeds from sale of furniture and
equipment
|
|
|
|
|
|
|
|
|
51,119
|
|
Organization costs incurred
|
|
|
|
|
|
|
|
|
(622,755
|
)
|
Cash acquired in acquisition of control of
joint venture
|
|
|
|
|
|
|
|
|
991,634
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(37,436
|
)
|
|
(123,706
|
)
|
|
(3,306,371
|
)
|
F-26
Index
AVAX Technologies,
Inc. and Subsidiaries
(a development stage company)
Consolidated
Statements of Cash Flows (continued)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
from January
12, 1990
(Incorporation)
Through Sept. 30,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of notes payable to related party
|
|
$
|
|
|
$
|
|
|
$
|
957,557
|
|
Principal
payments on notes payable to related party
|
|
|
|
|
|
|
|
|
(802,000
|
)
|
Proceeds from loans payable and the related
issuance of warrants
|
|
|
|
|
|
|
|
|
2,314,000
|
|
Principal payments on loans payable
|
|
|
|
|
|
|
|
|
(1,389,000
|
)
|
Payments for fractional shares from reverse
splits and preferred stock conversions
|
|
|
|
|
|
|
|
|
(76
|
)
|
Financing costs incurred
|
|
|
|
|
|
|
|
|
(90,000
|
)
|
Payments received on subscription receivable
|
|
|
|
|
|
|
|
|
93,637
|
|
Shareholder capital contribution
|
|
|
|
|
|
|
|
|
4,542
|
|
Proceeds received from exercise of stock
warrants
|
|
|
|
|
|
|
|
|
76,892
|
|
Elimination of the consolidated accounting
treatment for joint venture
|
|
|
|
|
|
|
|
|
(2,511,701
|
)
|
Capital contribution through sale of
interest in consolidated subsidiaries
|
|
|
|
|
|
|
|
|
2,624,000
|
|
Net proceeds received from issuance of
preferred and common stock
|
|
|
|
|
|
9,318,360
|
|
|
78,170,851
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
9,318,360
|
|
|
79,448,702
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
|
|
19,271
|
|
|
(26,468
|
)
|
|
444,093
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and cash
equivalents
|
|
|
(3,128,620
|
)
|
|
6,199,002
|
|
|
7,683,572
|
|
Cash and cash equivalents at beginning of period
|
|
|
5,573,150
|
|
|
1,484,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
2,444,530
|
|
$
|
7,683,572
|
|
$
|
7,683,572
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
|
|
$
|
|
|
$
|
197,072
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash activity:
|
|
|
|
|
|
|
|
|
|
|
Conversion of accounts payable into notes payable
|
|
$
|
|
|
$
|
|
|
$
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock warrants issued in conjunction with convertible notes payable
|
|
$
|
|
|
$
|
|
|
$
|
142,500
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of bridge loans into common
stock
|
|
$
|
|
|
$
|
|
|
$
|
950,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of interest on bridge loans with
common stock
|
|
$
|
|
|
$
|
|
|
$
|
23,275
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-27
Index
AVAX Technologies, Inc. and Subsidiaries
(a development stage company)
Notes to Consolidated Financial
Statements
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
|
|
1.
|
Organization and Summary of
Significant Accounting Policies
|
AVAX Technologies, Inc., with its subsidiaries (the
Company), is a development stage biopharmaceutical company.
In November 1995, the Company sold its leading product
under development, an over-the-counter nutritional, dietary, medicinal food
supplement or drug and all of the related patents and other intellectual
property. The agreement was for $2.4 million in shares of common stock of
Interneuron Pharmaceuticals, Inc. (IPI), a public company, the parent of the
purchaser of the product (the Stock). Certain common stockholders of the
Company were also common stockholders of IPI. Pursuant to the terms of the
agreement, the purchase price, payable in two equal installments in December
1996 and 1997, was fixed, and the number of shares of the Stock would vary depending
on the quoted market price of the Stock at such time. Because the Stock was
receivable in two equal annual installments, the gain from the sale of the
product, $1,951,000, was calculated by discounting the value of the Stock
receivable using a discount rate of 15%.
Also in November 1995, the Company entered into a
license agreement with Thomas Jefferson University (TJU) to develop,
commercially manufacture and sell products embodying immunotherapeutic vaccines
for the treatment of malignant melanoma and other cancers (the Invention)
(see
Note 2
).
Since January 1997, the Company has also entered into
license agreements with other universities to develop, commercially manufacture
and sell products embodying a series of compounds for the treatment of cancer.
The Company has since terminated each of these license and related research
agreements after determining that further development of these compounds was no
longer consistent with the strategic plan and plan of operation of the Company.
In August 2000, the Company completed its acquisition
of GPH, S.A. (Holdings) and Genopoietic S.A. (Genopoietic) each a French
societe anonyme, with its principal operating facility in Lyon, France. The
Company has designated the Lyon, France operations facility as its primary
source facility for the production of vaccines to be used in clinical trials.
In addition, the Company currently performs contract manufacturing and research
activities at its facility located in Lyon. The Companys September 30, 2007, consolidated
balance sheet includes approximately $89,510 in net assets related to these
subsidiaries.
The Companys business is subject to significant risks
consistent with biotechnology companies that are developing products for human
therapeutic use. These risks include, but are not limited to, uncertainties
regarding research and development, access to capital, obtaining and enforcing
patents, receiving regulatory approval, and competition with other
biotechnology and pharmaceutical companies. The Company plans to continue to
finance its operations with a combination of equity and debt financing and, in
the longer term, revenues from product sales, if any. However, there can be no
assurance that it will successfully develop any product or, if it does, that the
product will generate any or sufficient revenues.
Basis of
Presentation
The financial information as of September 30, 2007,
and for the three and nine-month periods ended September 30, 2007 and 2006,
contained herein is unaudited. The Company believes this information has been
prepared in accordance with accounting principles generally accepted in the
U.S. for interim financial information and Article 10 of Regulation S-X. The
Company also believes this information includes all adjustments (consisting only
of normal recurring adjustments) necessary to present fairly the financial
position, results of operations and cash flows for the periods then ended. The
results of operations for the three and nine-month periods ended September 30,
2007, are not necessarily indicative of the results of operations that may be
expected for the entire year.
The accompanying financial statements and the related
notes should be read in conjunction with the Companys audited financial
statements for the year ended December 31, 2006, included in the Companys
annual report on Form 10-KSB.
Principles
of Consolidation
The accompanying consolidated financial statements
include the accounts of AVAX Technologies, Inc., and its subsidiaries. All
significant intercompany balances and transactions have been eliminated.
F-28
Index
Revenue
The Companys revenues are related to the provision of
contract services and the sale of its product, the AC Vaccine Technology, for
the treatment of melanoma. Contract service revenue is recognized in installments
based upon the contractual agreement entered into with clients. Product
revenues represent fees received or payable to the Company. Product revenue is
recognized when the vaccine is received by the hospital administering the
vaccine.
The Company records as deferred revenue amounts
received in advance of the provision of services in accordance with contracts
or grants. Deferred revenue consisted of $213,902 received from a grant for
which the services had not been provided as of September 30, 2007. In February
2007, the Company entered into a collaborative agreement with Cancer Treatment
Centers of America for work related to clinical trials and certain production
activities out of the Companys facility in Philadelphia, Pennsylvania. In
accordance with the agreement, the Company received $250,000 as an up-front
payment related to re-commissioning its Philadelphia facility. These amounts
are treated as deferred revenue until such time as the facility launches
operations.
Accounts Receivable
Accounts receivable are stated at the amount
management expects to collect from outstanding balances. Management provides
for probable uncollectible accounts through a charge to earnings and a credit
to a valuation allowance based on its assessment of the current status of
individual accounts. Balances that are still outstanding after management has
used reasonable collection efforts are written off through a charge to the
valuation allowance and a credit to accounts receivable. There was no valuation
allowance at September 30, 2007. The Company generally does not charge interest
on accounts receivable.
Concentrations of Credit Risk
Financial instruments that potentially subject the
Company to credit risk are principally cash and accounts receivable. Cash
consists of checking accounts, money market accounts and a certificate of
deposit. The Company places its cash with its principal bank, which is a high
credit quality financial institution. Cash deposits generally are in excess of
the FDIC insurance limits. Credit limits, ongoing credit evaluations, and
account monitoring procedures are utilized to minimize the risk of loss from
accounts receivable. Collateral is generally not required.
Fair
Value of Financial Instruments
The carrying amount of accounts receivable, accounts
payable and accrued liabilities are considered to be representative of their
respective fair values due to their short-term nature.
Inventories
Inventories are stated at the lower of cost or market,
determined using the first-in, first-out method, or market. The Companys
inventories include raw materials and supplies used in research and development
activities.
Accrued
Expenses
The Company provides a provision for accrued expenses
based upon its contractual obligation, as calculated by the Company, for all
claims made for payment to the Company.
Depreciation
Depreciation is computed using the straight-line method over the
estimated useful lives of furniture and equipment, which range from three to
ten years. Depreciation for the Companys manufacturing facility and related
equipment are computed using the straight-line method over estimated useful
lives of 5 to 10 years. Leasehold improvements related to the building are
being amortized using the straight-line method over the actual life of the lease.
F-29
Index
Goodwill
The Company adopted SFAS No.
142, Goodwill and Other Intangible Assets on January 1, 2002. This
accounting standard requires that goodwill and indefinite lived tangible assets
no longer be amortized but instead be tested at least annually for impairment
and expensed against earnings when the implied fair value of a reporting unit,
including goodwill, is less than its carrying amount. The Company performed its
annual goodwill impairment test in accordance with SFAS No. 142 and determined
that the carrying amount of goodwill was reasonable.
Prior to the adoption of
SFAS No. 142, the Company had recorded cumulative amortization of $113,032. If
SFAS No. 142 had been applied to earlier periods, the adjusted loss from
continuing operations would be $82,551,064 and the adjusted net loss would be
$82,554,909.
Research
and Development Costs
Research and development costs, including payments
related to research and license agreements, are expensed when incurred.
Contractual research expenses are recorded pursuant to the provisions of the
contract under which the obligations originate. Research and development costs
include all costs incurred related to the research and development, including
manufacturing costs incurred, related to the Companys research programs. The
Company is required to produce its products in compliance with current Good
Manufacturing Practices (cGMP), which requires a minimum level of staffing,
personnel and facilities testing and maintenance. Based upon its current
staffing level required to be in compliance with cGMP, the Company has excess
capacity. Utilizing this excess capacity, revenue is generated through contract
manufacturing engagements. Costs for production of products will be capitalized
and charged to cost of goods sold only after the Company has received approval
to market the drug by a regulatory authority.
Stock-Based
Compensation
Effective January 1, 2006, the Company has adopted
SFAS 123(R), Share-Based Payment. SFAS 123(R) establishes standards
for the accounting for transactions in which an entity exchanges its equity
instruments for goods or services and requires that the compensation cost
relating to share-based payment transactions be recognized in financial
statements, measured by the fair value of the equity or liability instruments
issued, adjusted for estimated forfeitures. We transitioned to SFAS 123(R)
using the modified-prospective method, under which prior periods have not been
revised for comparative purposes. The valuation provisions of SFAS 123(R) apply
to new grants and to grants that were outstanding as of the effective date and
are subsequently modified. Estimated compensation for grants that were
outstanding as of the effective date will be recognized over the remaining
service period using the compensation cost previously estimated for our SFAS
123 pro forma disclosures. Recognized stock-based compensation expense for the
six months ended September 30, 2007, includes compensation expense for
share-based payment awards granted prior to, but not yet vested as of
December 31, 2006, based on the grant date fair value estimated in
accordance with the pro forma provisions of SFAS 123 and compensation expense
for the share-based payment awards granted subsequent to December 31,
2006, based on the grant date fair value estimated in accordance with the
provisions of SFAS 123(R).
Prior to the adoption of SFAS 123(R), the Company
applied the intrinsic-value-based method of accounting prescribed by Accounting
Principles Board Opinion (APB) 25, Accounting for Stock Issued to
Employees, and related interpretations, to account for its fixed-plan stock
options to employees. Under this method, compensation cost was recorded only if
the market price of the underlying stock on the date of grant exceeded the
exercise price. SFAS 123, Accounting for Stock-Based Compensation,
established accounting and disclosure requirements using a fair-value-based
method of accounting for stock-based employee compensation plans. As permitted
by SFAS 123, the Company elected to continue to apply the intrinsic-value-based
method of accounting described above, and adopted only the disclosure
requirements of SFAS 123, as amended by SFAS No. 148, Accounting for
Stock-Based Compensation, Transition and Disclosure. The fair-value-based method
used to determine historical pro forma amounts under SFAS 123 was similar in
most respects to the method used to determine stock-based compensation expense
under SFAS 123(R). However, in its pro forma disclosures, the Company accounted
for option forfeitures as they occurred, rather than based on estimates of
future forfeitures.
F-30
Index
The Company maintains two employee stock option plans,
a director stock option plan and has issued non-qualified stock options to
employees and directors based upon the consent of the Board of Directors of
the Company. These plans are more fully discussed in the Form 10-KSB filed for
the year ended December 31, 2006. In addition, the Company issues warrants to
consultants at the discretion of the Board of Directors of the Company. The
Company accounts for warrants granted to consultants in accordance with
Emerging Issues Task Force Issue 96-18, Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. The Company determines the value of stock warrants
utilizing the Black-Scholes option-pricing model.
Compensation costs for fixed awards with pro rata
vesting are allocated to periods on the straight-line basis. For the nine-month
period January 1, 2007 through September 30, 2007 there were 3,820,000 options
to purchase common stock. The aggregate expense of these options is $382,000
(estimated weighted average fair value of $0.10 per share) that will be
recognized over the expected live of the options which is estimated at 4 years.
For the nine-months ended September 30, 2009, the estimated weighted average
fair value of options granted was calculated at $0.18 per share based on the
following assumptions:
`
|
|
|
|
|
|
|
|
|
|
|
Three & Nine Months
Ended September 30, 2006
|
|
|
Three &Nine Months
Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
Expected term (in years)
|
|
|
4.50
|
|
|
4.00
|
|
Volatility
|
|
|
79.4
|
%
|
|
75.4
|
%
|
Risk-free interest rate
|
|
|
4.30
|
%
|
|
3.52
|
%
|
Expected dividends
|
|
|
0
|
|
|
0
|
|
Compensation expense of $76,227 and $44,774 was
charged to administrative expenses for the nine months ended September 30, 2007
and 2006, respectively, while $68,284 and $61,044 was charged to research and
development expenses related to stock options outstanding and not vested for
the same periods.
A summary of applicable stock option and warrant
activity and related information for the nine months ended September 30, 2007,
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Options and Warrants
|
|
|
|
WeightedAverage
Exercise
Price
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at beginning of period
|
|
25,169,540
|
|
|
|
$
|
0.39
|
|
|
Granted
|
|
90,155,400
|
|
|
|
$
|
0.15
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
50,000
|
|
|
|
$
|
8.813
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of period
|
|
115,274,940
|
|
|
|
$
|
0.20
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of period
|
|
110,983,503
|
|
|
|
$
|
0.20
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of option grants is estimated at the
date of grant using the Black-Scholes model. The option and warrant contracts
expire at various times through July 2017. The weighted-average grant date fair
value of options granted during the years 2007 were $0.19.
F-31
Index
The following table shows the options and warrants
outstanding by strike price with the average expected remaining term of the
instruments at September 30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise Price Range
|
|
Options & Warrants
Outstanding
|
|
|
Weighted-Average Remaining Term
|
|
|
Vested Options & Warrants
|
|
|
Weighted-Average Remaining Term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.0 - $0.04
|
|
|
31,250
|
|
|
0.09
|
|
|
31,250
|
|
|
0.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.125 - $0.19
|
|
|
98,953,450
|
|
|
4.41
|
|
|
95,470,575
|
|
|
4.30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.29 - $0.47
|
|
|
15,620,240
|
|
|
2.59
|
|
|
14,811,678
|
|
|
2.47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.89 - $0.91
|
|
|
280,000
|
|
|
.99
|
|
|
280,000
|
|
|
.99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2.938
|
|
|
265,000
|
|
|
2.96
|
|
|
265,000
|
|
|
2.96
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$8.240
|
|
|
125,000
|
|
|
4.09
|
|
|
125,000
|
|
|
4.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,274,940
|
|
|
|
|
|
110,983,503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recently
issued accounting standards
In September 2006, the Financial Accounting Standards
Board (FASB) issued Statement of Financial Accounting Standards No. 157,
Fair Value Measurements (FAS 157).
FAS 157 defines fair value, establishes a framework for measuring fair
value in GAAP, and expands disclosures about fair value measurements. FAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. We are evaluating the impact, if
any, of adopting FAS 157 on our consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and Financial Liabilities
Including an Amendment of FASB Statement 115 (FAS 159). FAS 159 permits
entities to choose to measure many financial instruments and certain other
items at fair value. Entities that elect the fair value option will report
unrealized gains and losses in earnings at each subsequent reporting date. The
fair value option may be elected on an instrument-by-instrument basis, with few
exceptions. FAS 159 also establishes presentation and disclosure requirements
to facilitate comparisons between companies that choose different measurement attributes
for similar assets and liabilities. FAS 159 is effective for financial
statements issued for fiscal years beginning after November 15, 2007. We
are evaluating the impact, if any, of adopting FAS 159 on our consolidated
financial statements.
In June 2007, the FASB ratified Emerging Issues Task
Force (EITF) Issue No. 07-3, Accounting for Nonrefundable Advance Payments
for Goods or Services to Be Used in Future Research and Development Activities
(Issue 07-3), which addresses the accounting for nonrefundable advance
payments. The EITF concluded that nonrefundable advance payments for goods or
services to be received in the future for use in research and development
activities should be deferred and capitalized. The capitalized amounts should be
expensed as the related goods are delivered or the services performed. If an
entitys expectations change such that it does not expect it will need the
goods to be delivered or the services to be rendered, capitalized nonrefundable
advance payments should be charged to expense. Issue 07-3 is effective for new
contracts entered into during fiscal years beginning after December 15, 2007,
including interim periods within those fiscal years. We are evaluating the
impact, if any, of adopting Issue 07-3 on our consolidated financial
statements.
F-32
Index
|
|
2.
|
License
and Research Agreements
|
In November 1995, the Company entered into an
agreement with TJU for the exclusive worldwide license to develop, manufacture
and sell the Invention
(see Note 1)
. In consideration for the license agreement,
the Company paid cash of $10,000 and issued an aggregate of 458,243 shares of
common stock to TJU and the scientific founder (the Scientist).
Under the terms of the license agreement, the Company
is obligated to (i) pay certain milestone payments as follows: $10,000 upon
initiation of the first clinical trial that is approved by the Food and Drug
Administration (FDA) or comparable international agency, $10,000 upon the
first filing of a New Drug Application (NDA) with the FDA or comparable
international agency, and $25,000 upon receipt by the Company of approval from
the FDA or comparable international agency to market products, (ii) enter into
a research agreement to fund a study to be performed by TJU for the development
of the technology related to the Invention (the Study) at approximately
$220,000 per annum for the first three years, and (iii) following the third
year, spend an aggregate of $500,000 per year (which includes costs incurred
pursuant to the research agreement plus other internal and external costs) on
the development of the Invention until commercialized in the U.S. If the Company files for U.S. marketing
approval through a Company sponsored NDA, the Company may elect to spend less
than $500,000 per year on the development of the Invention during the period of
time the NDA is under review by the FDA.
During 2000, a payment of $25,000 was made to TJU pursuant to the
license agreement. In addition, the
Company is obligated to pay royalties on its worldwide net revenue derived from
the Invention and a percentage of all revenues received from sub-licensees of
the Invention.
The Companys French subsidiary received financial
support from a French governmental agency (ANVAR). These advances, are subject to conditions specifying that
non-compliance with such conditions could result in the forfeiture of all or a
portion of the future amounts to be received, as well as the repayment of all
or a portion of amounts received to date.
If certain products are commercialized, the September 30, 2007, balance
of $390,181 is repayable based on an annual royalty equal to 47% of the revenue
related to the project. As such, the
total amount of advances received are recorded as a liability in the accompanying
consolidated balance sheet. In case of
failure or partial success, as defined in the agreement, $86,707 (400,000
French Francs) is payable. The due date
for the obligation has past but the grantor agency has not demanded repayment
of the obligation. Due to the
uncertainty regarding the amount that will be required to be returned to ANVAR,
the Company maintains the full amount of the obligation as a current liability.
|
|
4.
|
Private Placement of Equity
Securities
|
On April 13, 2007, the Company closed a private
placement of 80,060,000 shares of common stock at a purchase price of $0.125
per share with 25 accredited and institutional investors. The Company received
gross proceeds of approximately $10,007,500, and incurred offering-related
expenses of $689,141 payable to advisors related to the fundraising. In connection with the private placement,
the Company also issued to the investors warrants to purchase 80,060,000 shares
of common stock at a warrant exercise price of $0.15 per share. All warrants issued in this private
placement expire on April 13, 2012.
|
|
5.
|
Conversion
of Series C Preferred
|
During the quarter ended September 30, 2007, 3,250 shares of Series C
convertible preferred stock were converted into 99,999 shares of common stock
in accordance with the conversion provisions of the Series C shares.
F-33
Index
PART
II INFORMATION NOT REQUIRED IN PROSPECTUS
|
|
Item 13.
|
Other Expenses of Issuance and
Distribution.
|
The
following table sets forth the costs and expenses, other than underwriting
discounts and commissions, payable by us in connection with the registration of
the shares of common stock being offered. All amounts are estimates except the
Securities and Exchange Commission registration fee.
|
|
Securities and Exchange Commission registration fee
|
$ 1,081
|
Legal fees and expenses
|
100,000
|
Accounting fees and expenses
|
50,000
|
Blue sky fees and expenses
|
25,000
|
Transfer agent fees and expenses
|
5,000
|
|
|
Total
|
$ 181,081
|
|
|
|
|
Item 14
.
|
Indemnification of Directors and
Officers
.
|
Our
company was organized under the laws of the State of Delaware, and therefore we
are subject to Section 145 of the General Corporation Law of the State of
Delaware. Section 145 authorizes a court to award or a corporations board of
directors to grant indemnification to directors and officers in terms broad
enough to include indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the Securities
Act of 1933, as amended.
Article
Seven of our Certificate of Incorporation provides that we will indemnify and
advance expenses to our directors and officers to the fullest extent permitted
by Section 145. Article Nine of our Certificate of Incorporation provides that
the liability of our directors is eliminated to the fullest extent permitted by
Section 102(b)(7) of the Delaware General Corporation Law.
Article
V, Section 1 of our By-Laws provides for mandatory indemnification of our
directors to the fullest extent authorized by the Delaware General Corporation
Law. Article V, Section 2 of our By-Laws provides for prepayment of expenses
incurred by our directors to the fullest extent permitted by, and only in
compliance with, the Delaware General Corporate Law. Article V, Section 6 of
our By-Laws provides for permissive indemnification of our officers, employees
and agents if and to the extent authorized by our board of directors in
compliance with the Delaware General Corporation Law.
These
provisions in the Certificate of Incorporation and the By-Laws do not eliminate
the directors fiduciary duty, and in appropriate circumstances equitable
remedies such as injunctive or other forms of non-monetary relief will remain
available under Delaware law. In addition, each director will continue to be
subject to liability for breach of the directors duty of loyalty to us for
acts or omissions not in good faith or involving intentional misconduct, for
knowing violations of law, for actions leading to improper personal benefit to
the director, and for payment of dividends or approval of stock repurchases or
redemptions that are unlawful under Delaware law. The provisions also do not
affect a directors responsibilities under any other law, such as the federal
securities laws or state or federal environmental laws. In addition, we have
obtained certain liability insurance coverage for our directors and officers.
|
|
Item 15
.
|
Recent Sales of Unregistered
Securities.
|
On
April 5, 2005, we closed a private placement of 25,343,430 shares of
common stock at a purchase price of $0.34 per share with 12 accredited or institutional
investors. We received gross proceeds of approximately $8,616,000. In
connection with the private placement, we also issued to the investors warrants
to purchase 3,801,515 shares of common stock at a warrant exercise price of
$0.41 per share, and warrants to purchase 3,801,515 shares of common stock at a
warrant exercise price of $0.48 per share. In addition, the company issued
warrants to its advisors relating to this fundraising to purchase 2,287,293
shares of common stock at a warrant exercise price of $0.37 per share. These
warrants were valued at $435,705 using the Black-Scholes pricing model.
Offering related expenses in connection with this fundraising amounted to
$1,065,945 of which $630,240 was paid in cash and the balance relates to the warrants
issued to the advisors. We are using the proceeds of this private offering for
general working capital purposes, including funding our current plan of
operation discussed below. The common stock and warrants were issued to
accredited investors only in reliance upon Regulation D under Section 4(2) of
the Securities Act.
II-1
Index
In addition, on April 13, 2007, we closed a
private placement of 80,060,000 shares of common stock at a purchase price of $0.125 per share with 25 accredited or institutional
investors. We received gross proceeds of $10,007,500. In connection with the private placement, we also issued to the investors
warrants to purchase 80,060,000 shares of common stock at a warrant exercise price of $0.15 per share. In addition, we have agreed
to pay $580,350 and to issue warrants to purchase 6,190,400 shares of common stock at a warrant exercise price of $0.15 per share
to certain advisors relating to this private offering. We will receive net proceeds from this private offering, after offering
related expenses, of approximately $9.0 million. We are using the net proceeds to continue to implement the plan of operation
described in the prospectus. The common stock and warrants were issued to accredited investors only in reliance upon Regulation D
of the Securities Act.
EXHIBIT
INDEX
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
3.1
|
|
|
Certificate of Incorporation, as amended (excluding
the Certificates of Designations for the Series B and Series C Convertible
Preferred Stock).
1
|
|
|
|
|
3.2
|
|
|
Certificate of Amendment of Certificate of
Incorporation Dated May 10, 2004.
2
|
|
|
|
|
3.3
|
|
|
Certificate of Amendment of Certificate of
Incorporation Dated February 20, 2007.
17
|
|
|
|
|
3.4
|
|
|
By-Laws.
3
|
|
|
|
|
4.1
|
|
|
Reference is made to Exhibits 3.1, 3.2 and 3.3.
|
|
|
|
|
4.2
|
|
|
Specimen of common stock certificate.
3
|
|
|
|
|
4.3
|
|
|
Certificate of Designation of Series C Convertible
Preferred Stock.
4
|
|
|
|
|
5.1
|
|
|
Opinion of Gilmore & Bell, P.C.
*
|
|
|
|
|
10.1
|
|
|
Clinical Study and Research Agreement dated November
20, 1995, by and between the Company and Thomas Jefferson University.
7
|
|
|
|
|
10.2
|
|
|
License Agreement dated November 20, 1995, by and
between the Company and Thomas Jefferson University.
5
|
|
|
|
|
10.3
|
|
|
Extension to the Clinical Study and Research Agreement
dated November 20, 1995, by and between the Company and Thomas Jefferson
University.
4
|
|
|
|
|
10.4
|
|
|
Stock Contribution Agreement dated as of July 17,
2000, among the Company, Professor David R. Klatzmann, Professor Jean-Loup
Salzmann, GPH, S.A. and Genopoietic, S.A
12
|
|
|
|
|
10.5
|
|
|
Tax Agreement dated as of August 24, 2000, among the
Company, GPH, S.A., Genopoietic S.A., Professor David R. Klatzmann and
Professor Jean-Loup Salzmann.
12
|
|
|
|
|
10.6
|
|
|
Rights Agreement dated as of August 24, 2000,
between the Company and Professor David R. Klatzmann (an identical agreement
was entered into between the Company and Professor Jean-Loup Salzmann).
12
|
|
|
|
|
10.7
|
|
|
2001 Stock Option Plan.
1
|
|
|
|
|
10.8
|
|
|
2000 Directors Stock Option Plan.
6
|
|
|
|
|
10.9
|
|
|
2006 Equity Incentive Plan.
14
|
|
|
|
|
10.10
|
|
|
Note Purchase Agreement dated as of November 17,
2003.
7
|
|
|
|
|
10.11
|
|
|
Form of Warrant in connection with the December 2003
bridge financing.
7
|
|
|
|
|
10.12
|
|
|
Form of Series 2004A Warrant to purchase common
stock.
9
|
II-2
Index
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
|
|
10.13
|
|
Form of Series 2004B Warrant to purchase common
stock.
9
|
|
|
|
|
|
10.14
|
|
Employment Agreement between AVAX Technologies, Inc.
and Richard P. Rainey dated as of April 1, 2004.
10
|
|
|
|
|
|
10.15
|
|
Letter Agreement between AVAX Technologies, Inc. and
Richard P. Rainey dated as of October 2, 2007.
11
|
|
|
|
|
|
10.16
|
|
Employment Agreement between AVAX Technologies, Inc.
and Richard P. Rainey dated as of December 1, 2001.
16
|
|
|
|
|
|
10.17
|
|
Employment Letter between AVAX Technologies, Inc.
and Dr. David Berd dated as of November 1, 2004.
10
|
|
|
|
|
|
10.18
|
|
Employment Agreement between AVAX Technologies, Inc.
and Dr. Francois R. Martelet dated as of December 1, 2007.
16
|
|
|
|
|
|
10.19
|
|
Amendment to Employment Agreement between AVAX
Technologies, Inc. and Dr. Francois R. Martelet dated as of December 1, 2007.
16
|
|
|
|
|
|
10.20
|
|
Form of Series 2005A Warrant to purchase common
stock.
12
|
|
|
|
|
|
10.21
|
|
Form of Series 2005B Warrant to purchase common
stock.
12
|
|
|
|
|
|
10.22
|
|
Securities Purchase Agreement dated as of April 13,
2007.
15
|
|
|
|
|
|
10.23
|
|
Form of Series 2007A Warrant to purchase common
stock.
15
|
|
|
|
|
|
21.1
|
|
Subsidiaries of the Company.
*
|
|
|
|
|
|
23.1
|
|
Consent of Gilmore & Bell, P.C. included in
Exhibit 5.1.
|
|
|
|
|
|
23.2
|
|
Consent of Briggs, Bunting & Dougherty LLP,
Independent Registered Public Accounting Firm.
*
|
|
|
|
*
|
Filed herewith.
|
1
|
Incorporated by reference and previously filed as an
exhibit to Annual Report on Form 10-KSB for year ended December 31,
2001.
|
2
|
Incorporated by reference and previously filed as an
exhibit to the Quarterly Report on Form 10-QSB for the first quarter of the
year ended December 31, 2004.
|
3
|
Incorporated by reference and previously filed as an
exhibit to the Registration Statement on Form S-3 (File No. 333-09349) filed
on August 1, 1996.
|
4
|
Incorporated by reference and previously filed as an
exhibit to the Annual Report on Form 10-KSB for the year ended
December 31, 1998.
|
5
|
Incorporated by reference and previously filed as an
exhibit to Amendment No. 9 to the Registration Statement on Form S-3 filed on
July 3, 1997.
|
6
|
Incorporated by reference and previously filed as an
exhibit to the Annual Report on Form 10-KSB for year ended December 31, 2000.
|
7
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on December 9, 2003.
|
8
|
Incorporated by reference and previously filed as an
exhibit to the Registration Statement on Form SB-2 (File No. 333-118334) filed
on August 18, 2004.
|
9
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on June 2, 2004.
|
10
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on March 18, 2005.
|
11
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on October 18, 2007.
|
12
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on April 7, 2005.
|
13
|
Incorporated by reference and previously filed as an
exhibit to the Annual Report on Form 10-KSB for year ended December 31, 2000.
|
II-3
Index
|
|
14
|
Incorporated by reference and previously filed as an
exhibit to the Proxy Statement on Schedule 14A as filed with the SEC on June
28, 2006.
|
15
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K filed on April 19, 2007.
|
16
|
Incorporated by reference and previously filed as an
exhibit to the Current Report on Form 8-K/A, Amendment No. 1 filed on
February 1, 2008.
|
17
|
Incorporated by reference and previously filed as an
exhibit to the Annual Report on Form 10-KSB for year ended December 31, 2006.
|
II-4
Index
We hereby undertake:
|
The undersigned registrant hereby undertakes:
|
|
(1)
|
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
|
(i)
|
To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
|
|
(ii)
|
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the Calculation of Registration Fee table in the effective registration
statement; and
|
|
(iii)
|
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.
|
|
(2)
|
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
|
(3)
|
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
|
|
(4)
|
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
|
(i)
|
each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such
document immediately prior to such date of first use.
|
II-5
Index
|
(5)
|
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
|
|
(i)
|
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
|
|
(ii)
|
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
|
|
(iii)
|
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
|
|
(iv)
|
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
(h)
|
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
|
II-6
Index
SIGNATURES
Pursuant to
the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe
that it meets all of the requirements of filing on Form S-1 and authorizes this registration statement to be signed on its behalf
by the undersigned, in the City of Philadelphia, State of Pennsylvania, on this 8
th
day of February 2008.
|
|
|
|
AVAX TECHNOLOGIES, INC.
|
|
|
|
By:
|
/s/ Francois R. Martelet, M.D.
|
|
|
|
|
|
Francois R. Martelet, M.D.
|
|
|
President
and Chief Executive Officer
|
POWER OF ATTORNEY
We, the undersigned officers and directors of AVAX
Technologies, Inc., severally constitute Francois R. Martelet, M.D. and John K.A. Prendergast, or either of them, in the order
named, our true and lawful attorney-in-fact with full power to each, to sign for us and in our names in the capacities indicated
below, the registration statement on Form S-1 filed with this registration statement and any and all subsequent amendments to this
registration statement, and generally to do all things in our names and on our behalf in our capacities as officers and directors
to enable AVAX Technologies, Inc. to comply with all requirements of the SEC.
Pursuant to
the requirements of the Securities Act of 1933, as amended, the registration statement has been signed by the following persons in
the capacities and on the dates indicated:
|
|
|
Signature
|
Name & Title
|
Date
|
|
|
|
|
|
|
/s/ Francois R. Martelet, M.D.
|
Francois R. Martelet, M.D.
|
February 8, 2008
|
|
President, Chief Executive Officer and Director
|
|
|
(Principal Executive Officer)
|
|
|
|
|
/s/ Richard P. Rainey
|
Richard P. Rainey
|
February 8, 2008
|
|
Principal Financial Officer
|
|
|
Principal Accounting Officer
|
|
|
|
|
/s/ John K.A. Prendergast
|
John K. A. Prendergast, Ph.D.
|
February 8, 2008
|
|
Chairman of the Board and Director
|
|
|
|
|
/s/ Andrew Dahl
|
Andrew Dahl
|
February 8, 2008
|
|
Director
|
|
|
|
|
/s/ Edson D. de Castro
|
Edson D. de Castro
|
February 8, 2008
|
|
Director
|
|
|
|
|
/s/ Carl Spana
|
Carl Spana, Ph.D.
|
February 8, 2008
|
|
Director
|
|
II-7
AVAX Technologies (CE) (USOTC:AVXT)
過去 株価チャート
から 11 2024 まで 12 2024
AVAX Technologies (CE) (USOTC:AVXT)
過去 株価チャート
から 12 2023 まで 12 2024