SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
September 30, 1999 (September 14, 1999)
Date of Report (Date of earliest event reported)
AVAX TECHNOLOGIES, INC.
(Exact name of Registrant as specified in its charter)
Delaware 000-29222 13-3575874
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification Number)
4520 Main Street
Suite 930
Kansas City, MO 64111
(Address of principal executive offices)
(816) 960-1333
(Registrant's telephone number, including area code)
Page 1 of 5 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
The sole purpose of this Form 8K is to file a press release issued by AVAX
Technologies, Inc. on September 14, 1999 which announced that pursuant to
discussions with various regulatory agencies the Company may begin to
commercialize it's product, M-Vax(TM) in The Netherlands, Germany and Japan. A
full reprint of the article is attached as Exhibit 99.9.
Item 7. Financial Statements and Exhibits.
Exhibits: 99.9 Press Release dated September 14, 1999.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
AVAX TECHNOLOGIES, INC.
Date: September 30, 1999
By: /s/ Jeffrey M. Jonas
----------------------------------
Name: Jeffrey M. Jonas, M.D.
Title: President and Chief
Executive Officer
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<PAGE>
Exhibit Index
Exhibit Number Description
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99.9 Press Release dated September 14, 1999.
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AVAX MELANOMA VACCINE M-VAX(TM) NEARING COMMERCIALIZATION
IN THE NETHERLANDS, GERMANY AND JAPAN
- Company Exploring Strategic Marketing Opportunities in these Regions -
KANSAS CITY, MISSOURI, -- September 14, 1999 - AVAX TECHNOLOGIES, INC. ("AVAX")
(Nasdaq: AVXT) announced today that, as a result of its continuing dialogue with
senior regulatory authorities in several of the world's major pharmaceutical
markets, its autologous cancer vaccine, M-Vax(TM), for Stage 3 metastatic
melanoma is expected to be made available for commercial use in The Netherlands,
Germany, and Japan. The commercialization of M-Vax in these countries will be
subject only to meeting certain requirements determined by each local regulatory
agency. In order to expedite the availability of M-Vax to melanoma patients in
these countries, AVAX is actively exploring a number of strategic options to
assist in realizing these opportunities and ensuring a successful
commercialization process.
In June 1999, AVAX announced its first international commercialization
opportunity for M-Vax in Australia, as well as a planned joint venture to manage
its products in this market. AVAX plans to begin marketing M-Vax in Australia in
the first half of 2000.
Commenting on these international developments, Jeffery M. Jonas, M.D.,
President & CEO of AVAX Technologies, stated, "We are very excited to be moving
forward with M-Vax in several important international markets. We believe that
these are significant developments for the company, as we build momentum in our
international commercialization efforts. We are certainly committed to expanding
the company's global presence in the field of cancer vaccines, and are
continually pursuing other international market opportunities, while we seek
approval of our AC Vaccine(TM) technology here in the U.S. As we develop our
strategic options, we look forward to communicating our commercialization
timelines with our investors."
M-Vax is the first of several autologous cell vaccines based on AVAX's
proprietary AC Vaccine(TM) technology. To date, more than 350 patients have been
treated with M-Vax on an outpatient basis. It has shown promising efficacy as
adjuvant therapy in Stage 3 melanoma patients, with overall 5-year survival of
55%, compared with an historical 5-year survival rate of only about 22% with
surgery alone. M-Vax, which received orphan drug status in February 1999, is
currently being evaluated in a multi-center, pivotal registration trial in the
United States. O-Vax(TM), the company's AC Vaccine for Stage 3 and advanced
- more -
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<PAGE>
AVAX Melanoma Vaccine M-Vax(TM) Nearing Commercialization in The Netherlands,
Germany and Japan
Page 2
ovarian cancer, which previously has shown promising immunological outcomes, is
currently being evaluated in two additional Phase 1 trials, one of which is
sponsored by the National Cancer Institute. Internationally, the University of
Tokyo is conducting a trial of the AC Vaccine in post-surgical breast cancer
patients.
AVAX's AC Vaccine technology is made from a patient's own cancer cells by
modifying the tumor cells with a molecule called a "hapten." This process, known
as "haptenization," alters the tumor cells and makes them appear foreign to the
patient's immune system. When the hapten-modified cells are reinjected into
patients, they stimulate the immune system to recognize the cancer cells and
destroy them.
AVAX Technologies, Inc. specializes in the development and commercialization
of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and
other life-threatening diseases using three core technologies: the AC Vaccine
technology, topoisomerase inhibitors and anti-estrogens.
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Except for statements that are historical, the statements in this release are
"forward-looking" statements that are made pursuant to the safe harbor
provisions of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements involve significant
risks and uncertainties, and in light of the significant uncertainties inherent
in such statements, the inclusion of such information should not be regarded as
a representation by AVAX that the objectives and plans of the company will be
achieved. In fact, actual results could differ materially from those
contemplated by such forward-looking statements. Many important factors affect
the company's ability to achieve the stated outcomes and to develop successfully
and commercialize its product candidates, including, the ability to obtain
substantial additional funds, to obtain and maintain all necessary patents or
licenses, to demonstrate the safety and efficacy of product candidates at each
state of development, to meet applicable regulatory standards and receive
required regulatory approvals, to meet obligations and required milestones under
its license agreements, to be capable of producing drug candidates in commercial
quantities at reasonable costs, to compete successfully against other products,
and to market products in a profitable manner, as well as other risks detailed
from time to time in AVAX's public disclosure filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-KSB for the year
ended December 31,1998. AVAX does not undertake any obligation to publicly
release any revisions to these forward-looking statements or to reflect the
occurrence of unanticipated events.
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