MYMX just filed an awesome 8k!!! I thought something had to be brewing. By the way, notice how cheap the company is, they didn't issue a PR to save their limited working capital. A long shot, not a scam.
ITEM 5. OTHER EVENTS.
WORLD PREMIERE: A PROTOTYPE AIDS VACCINE CANDIDATE HAS PRODUCED NEUTRALIZINGANTIBODIES AGAINST PRIMARY STRAINS OF THE HIV-AIDS VIRUS.
The first two (non optimized) variants of our cheaply scaleable, stable andmutated soluble trimeric forms of the gp41 transmembrane protein (the productionof 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 viewto determine 1) whether such injections are triggering the production ofantibodies, and 2) if yes, whether the resulting antibodies are in fact capableof neutralizing primary strains of HIV, the virus responsible for AIDS.
Primary HIV strains are obtained from HIV+ infected patients and are known to bemuch more resistant to neutralization than so-called laboratory strains, againstwhich certain groups have already obtained neutralizing antibodies, which laterturned out to be of no effect against primary strains.
Our work has demonstrated that both (non-optimized) variants of our mutatedproteins are:
1. strongly antigenic;
2. very stable in the presence of vaccine adjuvants previously approved by theFDA;
3. inducing seric antibodies which have a 50% or more neutralizing activity onearly 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. Bomseland her team have been working on mucosal transmission of HIV (and HIVtranscytosis) 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 amountof 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 UnitedStates in order to determine the breadth and depth of our discovery, which webelieve is adequately protected by several US and foreign patents and patentapplications.
Together with our strategic partner Protein' eXpert SA in Grenoble (France), aspin off of the French Nuclear Energy Agency ("Commissariat a l'energieatomique", CEA), we have launched the production of other variations of ourrecombinant stable trimeric gp41 in view of optimizing (and hopefully improvingon) our results. Due to the complexity of the matter, it is likely that morerounds of optimization will be required before the prototype vaccine can besubmitted to human clinical trials, which we do not expect to start before June2005.
Neutralizing antibodies are now accepted as a prime vaccine candidate by amajority of the scientific teams working on AIDS: this is why IAVI(International AIDS Vaccine Initiative, initially funded by the Bill and MelindaGates Foundation) has decided two years ago to concentrate its scientific andfinancial efforts on such antibodies and has consequently fostered theNeutralizing Antibodies Consortium (NAC), which coordinates the work ofprestigious 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 AFIRST EFFECTIVE YET NOT OPTIMIZED PROTOTYPE OF A PREVENTIVE AND POSSIBLYUNIVERSAL VACCINE AGAINST AIDS WHICH IS STABLE AND COULD BE MASS PRODUCED ATSMALL COSTS.
These encouraging results will be formally presented starting this comingSeptember to two major pharmaceutical companies active on the HIV-AIDS vaccinefront in anticipation of signing a partnership agreement. Experience tellshowever that encouraging results are no guarantee for the actual conclusion ofsuch partnership agreements and that concluding such agreements usually requiresseveral months.
We are still facing serious short term challenges, principally a shortage ofworking capital, that limits our ability to make greater progress in achievingour business plan.
ABOUT Mymetics
Mymetics Corporation is a Delaware registered biotech company operatingprimarily out of France and Switzerland and presently active in the research anddevelopment of preventive vaccines and therapies against AIDS, starting from afundamental 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 theyear 2000, it went through a reverse merger with ICHOR Corporation, a dormant UScompany previously listed on the NASDAQ that had sold essentially all of itsassets. The resulting company, the name of which was later changed to MymeticsCorporation, is currently listed on the OTCBB (trading symbol MYMX).
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements that involve risks anduncertainties. The statements contained in this report that are not purelyhistorical are forward-looking statements within the meaning of Section 21E ofthe Securities Exchange Act of 1934, as amended, and Section 27A of theSecurities Act of 1933, as amended. These forward looking statements concernmatters that involve risks and uncertainties that could cause actual results todiffer materially from those stated in the forward-looking statements. Wordssuch 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-lookingstatements are reasonable, we cannot guarantee future results, levels ofactivity performance or achievements, nor can we guarantee that our prototypevaccines will be proved effective under human clinical trials conditions.Moreover, neither we nor any other person assumes responsibility for theaccuracy and completeness of the forward-looking statements. We are under noduty to update any of the forward-looking statements after the date hereof toconform such statements to actual results or to changes in our expectations.
Readers are urged to carefully review and consider the various disclosures madeby us which attempt to advise interested parties of the factors which affect ourbusiness, including without limitation disclosures made under the captions"Management Discussion and Analysis of Financial Condition and Results ofOperations," "Risk Factors," "Consolidated Financial Statements" and "Notes toConsolidated Financial Statements" included in the Company's annual report onForm 10-K for the year ended December 31, 2003 and in our Registration Statementon Form S-1 dated May 22, 2002, as amended.
