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
August 18, 1999 (August 11, 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 (IRS Employer
of incorporation) File Number) 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 6 Pages
Exhibit Index Appears at Page 3
<PAGE>
Item 5. Other Events
The sole purpose of this Form 8-K is to file a press release issued by
AVAX Technologies, Inc. on August 11, 1999 which reported the Company's earnings
results for the Second Quarter ended June 30, 1999.
Item 7. Financial Statements and Exhibits.
Exhibits: 99.8 Press Release dated August 11, 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: August 18, 1999
By: /s/ Jeffrey M. Jonas
-----------------------------------------
Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive Officer
2
<PAGE>
Exhibit Index
Exhibit Number Description
- -------------- -----------
99.8 Press Release dated August 11, 1999.
3
EXHIBIT 99.8
Company Contacts: David Tousley, Chief Financial Officer
Richard Rainey, Controller
AVAX Technologies, Inc.
(816) 960-1333
Investors: Olga Fleming/Sue Yeoh
CPR Financial Communications
(201) 641-2408
Media: David Sassoon/Abenaa Hayes
The Rowland Company
(212) 527-7453
AVAX TECHNOLOGIES REPORTS 1999 SECOND QUARTER AND
SIX MONTH FINANCIAL RESULTS
KANSAS CITY, MISSOURI, -- August 11, 1999 - AVAX TECHNOLOGIES, INC.
("AVAX") (Nasdaq: AVXT) today announced financial results for the second quarter
ended June 30, 1999.
The net loss for the 1999 second quarter was $1,902,897, or $0.18 per share,
versus a net loss of $1,559,428, or $0.31 per share, reported in the same period
last year. The net loss for the six months ended June 30, 1999 was $3,542,808,
or $0.34 per share, compared with a net loss of $2,959,734 or $0.61 per share
for the first six months of 1998.
Research and development expenses were $1,272,463 for the 1999 second quarter,
and $2,331,501 for the six month period ended June 30, 1999, versus $1,152,779
in the second quarter of 1998 and $2,110,143 for the first six months of 1998.
Total operating loss was $2,086,105 for the 1999 second quarter and $3,869,087
for the six month period ended June 30, 1999, compared with a total operating
loss of $1,703,283 reported in the second quarter of 1998 and $3,338,299 for the
first six months of 1998. The increase in expenses for the quarter and six month
period were primarily attributable to increasing clinical activities including
costs associated with patient enrollment in a pivotal registration trial of
M-Vax(TM), an autologous cancer vaccine for malignant melanoma and the company's
lead development program, new costs associated with the company's expanding
commercial activities in Australia, as well as increased business development
costs.
Jeffrey M. Jonas, M.D., President and Chief Executive Officer, AVAX
Technologies, Inc., stated, "In the second quarter, we continued to focus our
energies on the corporate and product development initiatives integral to our
overall business strategy. During the quarter, we reached several significant
milestones, most importantly in the international arena, which will certainly
enhance our product development and commercialization efforts and may also lead
to revenue recognition as early as next year.
"Specifically, during the quarter we announced we will begin marketing M-Vax in
Australia, subject only to the licensure of a manufacturing facility. To support
this very exciting development, we formed a new subsidiary in Australia to
direct our commercialization efforts in this important region, and entered into
a letter of intent with Neptunus International Holdings Limited to manufacture
and market the AC Vaccine(TM) technology in both Australia and New Zealand. We
expect this collaboration to afford us many opportunities, including the ability
to validate our delivery model and demonstrate the vaccine's viability as an
important cancer therapeutic.
"Furthermore, in May we signed a collaborative research agreement with the
University of Tokyo to conduct a clinical trial of the AC Vaccine(TM) in breast
cancer. This clinical trial is an important step for AVAX, since we will be
applying our technology to a third cancer indication.
4
<PAGE>
"During the quarter we also received Orphan Drug designation from the U.S. Food
and Drug Administration for M-Vax, which has several benefits including
entitling the company to have exclusive marketing rights in the U.S. on the
vaccine for seven years following approval. The designation not only protects
our financial interests, but also provides us with additional support from the
FDA, as we continue to enroll patients into a multi-center pivotal registration
trial of M-Vax in the U.S."
Dr. Jonas concluded, "Overall, each of these achievements continues to
demonstrate our commitment to exploring additional near and long term product
and business opportunities in the U.S and in international markets. To that end,
we certainly look forward to the remainder of 1999, and to reporting our
progress."
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: autologous cell (AC)
vaccines, topoisomerase inhibitors and anti-estrogens.
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 29A 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, among other things, 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 stage 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 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.
- tables to follow -
5
<PAGE>
AVAX Technologies, Inc.
(a development stage company)
Statements of Operations
(Unaudited)
<TABLE>
<CAPTION>
Three months ended Six months ended
June 30, June 30,
1998 1999 1998 1999
------------------------------------------------------------
<S> <C> <C> <C> <C>
Gain from sale of the Product $ -- $ -- $ -- $ --
Costs and expenses:
Research and development 1,152,779 1,272,463 2,110,143 2,331,501
General and administrative 577,504 813,641 1,228,156 1,537,585
------------------------------------------------------------
Total operating loss (1,730,283) (2,086,104) (3,338,299) (3,869,086)
Other income (expense):
Interest income 170,855 183,207 378,565 326,278
------------------------------------------------------------
Total other income 170,855 183,207 378,565 326,278
------------------------------------------------------------
Net loss (1,559,428) (1,902,897) (2,959,734) (3,542,808)
------------------------------------------------------------
Net loss attributable to
common stockholders $ (1,559,428) $ (1,902,897) $ (2,959,734) $ (3,542,808)
============================================================
Net loss per common share $ (.31) $ (.18) $ (.61) $ (.34)
============================================================
Weighted average number of
shares outstanding 5,044,755 10,531,964 4,884,988 10,344,847
============================================================
</TABLE>
BALANCE SHEET HIGHLIGHTS
December 31, June 30,
1998 1999
(unaudited)
Cash and cash equivalents $ 344,940 $ 765,632
Marketable Securities 9,377,678 13,421,016
Total current assets 9,953,319 14,350,829
Total assets $ 11,143,733 $ 16,716,263
Total current liabilities $ 886,646 $ 582,695
Deficit accumulated during
Development stage (13,358,277) (16,901,085)
Total stockholders' equity 10,257,087 16,133,568
Total liabilities and stockholders' equity $ 11,143,733 $ 16,716,263
# # #
6
