UNITED STATES
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
Date of Report (Date of earliest event reported): July 28, 2004
MYMETICS CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE
(State of Incorporation)
000-25132 25-1741849
(Commission File Number) (I.R.S. Employer Identification No.)
14, RUE DE LA COLOMBIERE
1260 Nyon, SWITZERLAND
(Address of principal executive offices)
011 41 22 363 13 10
(Registrant's telephone number, including area code)
PART II. OTHER INFORMATION
ITEM 5. OTHER EVENTS.
WORLD PREMIERE: A PROTOTYPE AIDS VACCINE CANDIDATE HAS PRODUCED NEUTRALIZING
ANTIBODIES AGAINST PRIMARY STRAINS OF THE HIV-AIDS VIRUS.
The first two (non optimized) variants of our cheaply scaleable, stable and
mutated soluble trimeric forms of the gp41 transmembrane protein (the production
of which was announced as a major breakthrough in our filing 8-K dated April 16,
2004) have been inoculated to 38 germ-free rabbits over a 4-month period in view
to determine 1) whether such injections are triggering the production of
antibodies, and 2) if yes, whether the resulting antibodies are in fact capable
of neutralizing primary strains of HIV, the virus responsible for AIDS.
Primary HIV strains are obtained from HIV+ infected patients and are known to be
much more resistant to neutralization than so-called laboratory strains, against
which certain groups have already obtained neutralizing antibodies, which later
turned out to be of no effect against primary strains.
Our work has demonstrated that both (non-optimized) variants of our mutated
proteins are:
1. strongly antigenic;
2. very stable in the presence of vaccine adjuvants previously approved by the
FDA;
3. inducing seric antibodies which have a 50% or more neutralizing activity on
early transmitted (CCR5 tropic) primary strains of HIV (transcytosis test,
mimicking mucosal transmission, the major mode of infection).
The latter test has been performed (and twice repeated) by our partner, Dr.
Morgane Bomsel, principal investigator at the French National Research Institute
(CNRS), at her facilities at the Cochin Institute in Paris (France). Dr. Bomsel
and her team have been working on mucosal transmission of HIV (and HIV
transcytosis) and mucosal immunity aspects of AIDS since 1995. Since that date,
several groups active in this field all over the world have spent a great amount
of time and effort in the pursuit of the evasive primary neutralizing antibody,
with no positive response until Dr. Bomsel recently tested our antibodies.
Further tests are being conducted by other groups in France and the United
States in order to determine the breadth and depth of our discovery, which we
believe is adequately protected by several US and foreign patents and patent
applications.
Together with our strategic partner Protein' eXpert SA in Grenoble (France), a
spin off of the French Nuclear Energy Agency ("Commissariat a l'energie
atomique", CEA), we have launched the production of other variations of our
recombinant stable trimeric gp41 in view of optimizing (and hopefully improving
on) our results. Due to the complexity of the matter, it is likely that more
rounds of optimization will be required before the prototype vaccine can be
submitted to human clinical trials, which we do not expect to start before June
2005.
Neutralizing antibodies are now accepted as a prime vaccine candidate by a
majority of the scientific teams working on AIDS: this is why IAVI
(International AIDS Vaccine Initiative, initially funded by the Bill and Melinda
Gates Foundation) has decided two years ago to concentrate its scientific and
financial efforts on such antibodies and has consequently fostered the
Neutralizing Antibodies Consortium (NAC), which coordinates the work of
prestigious research centers such as the Scripps Institute in San Diego,
California, and private companies such as Virologic Inc. in San Francisco,
California.
In a nutshell and despite not being a member of the NAC, MYMETICS HAS PRODUCED A
FIRST EFFECTIVE YET NOT OPTIMIZED PROTOTYPE OF A PREVENTIVE AND POSSIBLY
UNIVERSAL VACCINE AGAINST AIDS WHICH IS STABLE AND COULD BE MASS PRODUCED AT
SMALL COSTS.
These encouraging results will be formally presented starting this coming
September to two major pharmaceutical companies active on the HIV-AIDS vaccine
front in anticipation of signing a partnership agreement. Experience tells
however that encouraging results are no guarantee for the actual conclusion of
such partnership agreements and that concluding such agreements usually requires
several months.
We are still facing serious short term challenges, principally a shortage of
working capital, that limits our ability to make greater progress in achieving
our business plan.
ABOUT Mymetics
Mymetics Corporation is a Delaware registered biotech company operating
primarily out of France and Switzerland and presently active in the research and
development of preventive vaccines and therapies against AIDS, starting from a
fundamental discovery made by its founder in 1997 about the HIV virus
(responsible for AIDS) and the way it disrupts the patient's immune system.
The company was founded in France under the name Hippocampe SA in 1990. In the
year 2000, it went through a reverse merger with ICHOR Corporation, a dormant US
company previously listed on the NASDAQ that had sold essentially all of its
assets. The resulting company, the name of which was later changed to Mymetics
Corporation, is currently listed on the OTCBB (trading symbol MYMX).
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements that involve risks and
uncertainties. The statements contained in this report that are not purely
historical are forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, as amended, and Section 27A of the
Securities Act of 1933, as amended. These forward looking statements concern
matters that involve risks and uncertainties that could cause actual results to
differ materially from those stated in the forward-looking statements. Words
such as "may," "will," "should," "could," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential", "continue", "possibly" or
"clearly" or similar words are intended to identify forward looking statements,
although not all forward looking statements contain these words.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, levels of
activity performance or achievements, nor can we guarantee that our prototype
vaccines will be proved effective under human clinical trials conditions.
Moreover, neither we nor any other person assumes responsibility for the
accuracy and completeness of the forward-looking statements. We are under no
duty to update any of the forward-looking statements after the date hereof to
conform such statements to actual results or to changes in our expectations.
Readers are urged to carefully review and consider the various disclosures made
by us which attempt to advise interested parties of the factors which affect our
business, including without limitation disclosures made under the captions
"Management Discussion and Analysis of Financial Condition and Results of
Operations," "Risk Factors," "Consolidated Financial Statements" and "Notes to
Consolidated Financial Statements" included in the Company's annual report on
Form 10-K for the year ended December 31, 2003 and in our Registration Statement
on Form S-1 dated May 22, 2002, as amended.
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.
Date: July 30, 2004 MYMETICS CORPORATION
By: /s/ Christian Rochet
------------------------
Christian Rochet,
President,
Chief Executive Officer