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
January 28, 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 4 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
The sole purpose of this Form 8-K is to file a press release issued by
AVAX Technologies, Inc. on January 28, 1999 regarding its financial results for
the fiscal year ended December 31, 1998.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits.
Exhibits: 99.1 Press Release dated January 28, 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: January 28, 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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99.1 Press Release dated January 28, 1999.
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EXHIBIT 99.1
Thursday January 28, 8:04 am Eastern Time
Company Press Release
SOURCE: AVAX Technologies, Inc.
AVAX Reports 1998 Results
KANSAS CITY, Mo., Jan. 28 /PRNewswire/ -- AVAX Technologies, Inc. (Nasdaq:
AVXT - news) reported a 1998 net loss of $5.8 million, or $.87 a share, versus
$4.3 million, or $1.14 a share, for 1997.
Research and development expenses in 1998 increased 64% to $4.0 million
from $2.4 million a year ago primarily as a result of progress in starting and
enrolling patients in the pivotal registration trial for melanoma, as well as
the initiation of clinical trials in ovarian cancer. General and administrative
expenses decreased 7% to $2.5 million from $2.7 million.
"It was a very successful year for AVAX Technologies as we made progress
on a number of important fronts," said Jeffrey M. Jonas, MD, president and chief
executive officer of the company. "The National Cancer Institute decided to
provide funding for a Phase I/II trial of O-VAX(TM), our ovarian cancer vaccine,
after eight out of nine patients with Stage 3 ovarian cancer in a study we
conducted developed an immune response to their own cancer cells after treatment
with O-VAX(TM)."
"The FDA also cleared the way for a pivotal trial for the registration of
M-VAX(TM), our melanoma vaccine, and registration is well underway for the study
which will involve more than 400 patients at 25 sites," Dr. Jonas continued. "We
have also had input with the FDA in its efforts to develop a regulatory
framework appropriate to this emerging vaccine technology, and this year we also
simplified the capital structure of the company by satisfying all obligations
with respect to the reset rights of holders of Series B Preferred Convertible
Stock."
Other significant developments during 1998 included the design and
commencement of build-out of the Company's GMP compliant clinical manufacturing
facility in Philadelphia, Pennsylvania. Completion of the facility is expected
in March of 1999.
At December 31, 1998, cash, cash equivalents and marketable securities
totaled approximately $9.7 million.
AVAX Technologies, Inc. is a development-stage biopharmaceutical company
that acquires rights to and is developing technologies and products for the
treatment of cancer and other life-threatening diseases. The company has focused
its initial clinical efforts primarily on the development of immunotherapies and
chemotherapies for cancer. Immunotherapy is a rapidly developing segment of the
therapeutic market.
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 the Private Securities Litigation Reform Act of 1995 and 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 successfully develop and commercialize its product
candidates, including, among other things, the ability to obtain substantial
additional funds, 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, without limitation, its Annual Report on Form
10-KSB for the fiscal year ended December 31, 1997 and its Quarterly Reports on
Form 10-QSB. 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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