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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2006
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM __________ TO __________
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COMMISSION FILE NUMBER 000-25132
MYMETICS CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE 25-1741849
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
European Executive Office
14, rue de la Colombiere
CH-1260 Nyon (Switzerland)
(Address of principal executive offices)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: 011 41 22 363 13 10
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK, $0.01 PAR VALUE
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes [ ] No [X]
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or Section 15(d) of the Act. Yes [ ] No [X]
If this report is a an annual or transition report, indicate by check mark
if the registrant is not required to file reports pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934. Yes [ ] No [X]
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed be Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K (Section 229.405 of this chapter) is not contained herein,
and will not be contained, to the best of registrant's knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. [ ]
Indicate by check mark whether the registrant is a large accelerated filer,
an accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer [X]
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X].
The aggregate market value of the voting common stock held by non-affiliates of
the Registrant (assuming officers and directors are affiliates) was
approximately U.S. $1,454,563 as of June 30, 2006, computed on the basis of the
average of the bid and ask prices on such date. The Registrant has no non-voting
common stock.
As of March 19, 2007, there were 135,627,464 shares of the Registrant's
Common Stock outstanding.
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USE OF EUROS
The financial information contained in this Form 10-K is provided in Euros
(E) (except in "Item 5. Market for Registrant's Common Equity and Related
Stockholder Matters" which is provided in United States Dollars, and except as
expressly indicated otherwise herein). See Note 1 to the Consolidated Financial
Statements contained in this Form 10-K for further explanation. As of March 17,
2007, 1 Euro was convertible into 1.33 United States Dollars.
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for forward-looking statements, which are identified by the words "believe,"
"expect," "anticipate," "intend," "plan" and similar expressions. The statements
contained herein which are not based on historical facts are forward-looking
statements that involve known and unknown risks and uncertainties that could
significantly affect our actual results, performance or achievements in the
future and, accordingly, such actual results, performance or achievements may
materially differ from those expressed or implied in any forward-looking
statements made by or on our behalf. These risks and uncertainties include, but
are not limited to, risks associated with our ability to successfully develop
and protect our intellectual property, our ability to raise additional capital
to fund future operations and compliance with applicable laws and changes in
such laws and the administration of such laws. These risks are described below
and in "Item 1. Business," "Item 7. Management's Discussion and Analysis of
Financial Condition and Results of Operations," and "Item 7A. Quantitative and
Qualitative Disclosures About Market Risk" included in this Form 10-K. Readers
are cautioned not to place undue reliance on these forward-looking statements
which speak only as of the date the statements were made.
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TABLE OF CONTENTS
PART I
ITEM 1. BUSINESS.......................................................... 1
ITEM 1A. RISK FACTORS...................................................... 13
ITEM 1B. UNRESOLVED STAFF COMMENTS......................................... 19
ITEM 2. PROPERTIES........................................................ 19
ITEM 3. LEGAL PROCEEDINGS................................................. 19
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS............... 20
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES................. 21
ITEM 6. SELECTED FINANCIAL DATA........................................... 25
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS............................................. 25
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK........ 32
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA....................... 34
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.............................................. 34
ITEM 9A. CONTROLS AND PROCEDURES........................................... 34
ITEM 9B. OTHER INFORMATION................................................. 34
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERANCE............. 35
ITEM 11. EXECUTIVE COMPENSATION............................................ 38
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS................................... 40
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE...................................................... 42
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES............................ 42
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES........................... 43
SIGNATURES................................................................. 67
ii
PART I
ITEM 1. BUSINESS
THE CORPORATION
OVERVIEW
We are a biotechnology research and development company devoted to fundamental
and applied research in the area of human biology and medicine conducting our
business from our European offices located in Lausanne and Nyon (near Geneva),
Switzerland. We were incorporated in July 1994 pursuant to the laws of the
Commonwealth of Pennsylvania under the name "PDG Remediation, Inc." In November
1996, we reincorporated under the laws of the State of Delaware and changed our
name to "ICHOR Corporation." In July 2001, we changed our name to "Mymetics
Corporation."
We own all of the outstanding voting stock of 6543 Luxembourg S.A., a joint
stock company organized in 2001 under the laws of Luxembourg, and 99.9% of
Mymetics S.A. (formerly Hippocampe S.A.), a company organized in 1990 under the
laws of France ("Mymetics S.A."), which is a subsidiary of 6543 Luxembourg S.A.
In this document, unless the context otherwise requires, "Mymetics" and the
"Corporation" refer to Mymetics Corporation and its subsidiaries.
We currently do not make, market or sell any products or services, and thus, we
have no revenues. We believe, however, that our research and development
activities will result in strong intellectual property that can generate
revenues for us in the future. Our business model is to conduct our research and
development far enough to sign a partnership agreement with one or more major
pharmaceutical companies active in either or both the fields of HIV-AIDS
preventive vaccines and therapies.
DEVELOPMENT OF THE COMPANY
From our inception in 1990 to December 1997, we operated in the environmental
services industry, focusing on thermal treatment, remediation services and waste
oil recycling. In February 1995, we completed an initial public offering. In
1998 and 1999, after disposing of our environmental services businesses, we
provided consulting services to an industrial customer in Europe. In June 1999,
we acquired a majority interest in Nazca Holdings Ltd., whose business involved
the exploration for and development of groundwater resources in Chile. Following
the disposal of our interest in Nazca in July 2000, we did not have an operating
business.
In March 2001, we acquired 99.9% of the outstanding shares of Mymetics S.A. in
consideration for shares of our common stock and shares of Class B Exchangeable
Preferential Non-Voting Stock of 6543 Luxembourg S.A., or Preferential Shares,
which are convertible into shares of our common stock. In 2002, we acquired all
but 0.01% of the remaining outstanding common stock of Mymetics S.A. pursuant to
share exchanges with the remaining stockholders of Mymetics S.A. The terms of
these share exchanges were substantially similar to the terms of the share
exchange that occurred in March 2001. In 2004, all the remaining convertible
shares of 6543 Luxembourg S.A. not already held by Mymetics Corporation were
converted into shares of Mymetics Corporation.
MYMETICS CORPORATION
Mymetics's primary objective is to develop vaccines and therapies to prevent and
treat the effects of certain retroviruses, including the human immunodeficiency
virus, or HIV, the virus that leads to acquired immunodeficiency syndrome, or
AIDS. Additional applications of Mymetics's research include potential
treatments and/or vaccines for human oncoviral leukemias, multiple sclerosis,
and organ transplantation.
Prior to 2002, our activities such as design of the prototype molecules,
synthesis, and in vitro testing, had been conducted exclusively in Europe.
During the second quarter of 2002, we launched programs in the United States in
an attempt to reinforce our intellectual property portfolio and to accelerate
the commercialization of our technology. Our previous management believed that
expanding
1
our operating activities in the United States offered numerous advantages,
including greater access to expertise, grants, subsidies, intellectual property
and public and private research teams. Due to financial constraints, it decided
to limit these activities in January 2003. Following the management changes of
July 2003, our activities have again been conducted exclusively in Europe, with
certain pre-clinical tests being performed in the United States by the National
Institutes of Health (NIH).
Under our "best of class" R&D model, the overall research strategy, as well as
most original ideas, are defined and contributed by our own scientific team,
including Dr. Sylvain Fleury, Ph.D. (Chief Scientific Officer) and Professor
Marc Girard, DVM, D.Sc. (Head of Vaccine Development). Any given project is
first subdivided into "technology modules" which are then subcontracted to "best
of class" teams from academia, public or private laboratories or industry, all
chosen for their high standards and specific knowledge. For example, if we need
rabbits to be bred, we will outsource this work on a commercial basis to the
best company we can find. Most of the work that we outsource is available
through other vendors and to date there have not been any providers that are the
only source of expertise that we require. We believe that having such
specialized expertise in-house would make us dependent on the staff required to
carry out such tasks. We believe we benefit from the established relationships
with our partners and that it is a cost effective approach to achieving our
business plan. Mymetics pays for and coordinates the work, consolidates the
results and retains all intellectual property associated with it. In certain
limited cases, we will sign partnership agreements with companies offering
technologies that can enhance or add value to our own products under
development. An example of this approach is the scientific collaboration
agreement with Pevion AG, a small Swiss company that granted us an exclusive
license to use their Virosome vaccine delivery technology in conjunction with
our AIDS preventive vaccine under development. Under this model, Mymetics
retains all intellectual property rights in the combined research and applies
for domestic and international patents whenever justified. In limited cases, the
patent ownership is shared with certain partners such as the French INSERM
(Institut National de la Sante Et de la Recherche Medicale). In this case,
Mymetics nevertheless received an exclusive license for the eventual
exploitation of the shared patents.
Our business model is to sign a partnership agreement with at least one of the
few major pharmaceutical companies presently active in the preventive vaccine
against HIV-AIDS as soon as our human clinical Phase I trials are completed. We
are trying to achieve this by June 2008. We expect that partnership agreement to
be typical in the world of biotechnology: an initial cash payment, followed by a
series of payments associated with specific milestones and finally, royalties on
any sales of end products, assuming these will have been approved by the various
regulatory authorities involved, such as the Food and Drug Administration. We
would not expect this to occur prior to 2010-2011.
LUXEMBOURG 6543 S.A.
Our Luxembourg subsidiary, Luxembourg 6543 S.A., was founded in 2001 in
connection with the acquisition of Mymetics S.A. by Mymetics Corporation as a
vehicle to allow the former French shareholders of Hippocampe S.A. to defer
French taxes due on the exchange of their Hippocampe S.A. shares for Mymetics
Corporation shares. Luxembourg 6543 S.A. is dormant. We intend to liquidate it
as soon as Mymetics S.A. is dissolved following its emergence from its
receivership status discussed below.
MYMETICS S.A.
Our French subsidiary, Mymetics S.A. (formerly, Hippocampe S.A.), founded in
1990, is a biotechnology research and development company devoted to fundamental
and applied research in the area of biology and medicine. The company is the
legal owner of our initial key patents, which were applied for prior to it being
acquired by Mymetics Corporation. At this time, it is not possible to transfer
these patents to any non-French legal entity without the French tax authorities'
approval. This approval requires an assessment of the actual economic value of
the patents, which the French tax authorities will only accept as resulting from
one or more arms-length transactions in which the technology protected by the
patents is licensed or sold to one or more third parties. Mymetics S.A. is
presently inactive. Its last salaried employee completed her assignment and had
her employment contract terminated on January 31, 2005. We do not intend to hire
new staff in France in the
2
foreseeable future, and all R&D will be conducted by Mymetics Corporation. We
intend to liquidate Mymetics S.A. as soon as it emerges from receivership,
discussed below.
On February 7, 2006, the Tribunal de Commerce in Lyon, France placed Mymetics
S.A., under receivership ("Redressement Judiciaire") as a result of an ongoing
dispute between Mymetics Corporation and a former officer and director, Dr.
Pierre-Francois Serres, who obtained an initial judgment against Mymetics S.A.
in France in the amount of E173,000 for an alleged wrongful termination by the
Company's prior management during 2003, which judgment was reversed on appeal.
The court appointed two judges to oversee the case, a lawyer to represent the
creditors and a judicial administrator to manage Mymetics S.A., all of whom are
considered agents of the court. The court further imposed a two-month
"observation period" during which management and the administrator should strive
to find a solution to the crisis. This period has been extended several times,
the last time until May 7, 2007. We expect to arrive at a viable solution before
the end of this observation period.
Under the order of the French court, Mymetics S.A. recently sold its patents to
Lomastar Technologies for E80,000 in order to pay its creditors and the
administration costs of the case. We do not believe that the sale of the patents
is significant to us since they expire in 2017 and 2018, the dates we first
expect to be selling the vaccine. To protect the value of our intellectual
property, however, we are negotiating an exclusive worldwide perpetual license
with Lomastar Technologies with respect to these patents that we hope to
conclude in the next several weeks. There can be no assurance, however, that we
will be successful in achieving this result, which could limit the value of our
intellectual property and the potential value of our company to a prospective
purchaser.
TECHNOLOGY
CURRENT APPROACHES
Current drug treatments in HIV focus on slowing or impeding the progress of the
virus once it has infected the body's host cells. Recent approaches seek to
develop therapies that prevent the virus from fusing with host cells. If the
virus cannot fuse, it cannot enter inside the cell(infect) and reproduce,
thereby facilitating the successful fight of the body's immune system against
the invasion.
HIV transmission generally occurs through sexual contact. Indeed, semen and
cervico-vaginal secretions may potentially transmit HIV to the gastrointestinal,
anorectal and genitourinary tracts because these fluids contain cell-free HIV
particles and numerous HIV-infected cells. Contracting HIV infection may be
subdivided into two main events. The first event, considered as a very early
step, corresponds to viral translocation across mucosal surfaces that
facilitates virus penetration and spreading into the body. The second event,
which usually takes place after virus translocation such as by transcytosis,
represents the infection step that leads to virus entry into target cells (ex.
CD4+ T lymphocytes). Therefore, the HIV vaccine should ideally elicit immune
responses not only in the blood but most importantly, also at the primary entry
site, which corresponds to two important anatomically compartments:
genital-reproductive tracts and intestine/rectal mucosal tissues. Therefore,
vaccines or therapies for preventing this very early event of HIV translocation
at the mucosa levels (ex. Transcytosis) became another important research
aspect.
Until recently, vaccine development was focusing on clade B strains, which
dominate the epidemic in industrialized countries but cause only about 12% of
infections globally. Development of non-clade B candidates, having clade C as a
key target became a priority and Mymetics seriously intends to invest all its
research effort in developing its "universal" vaccine, with a primary interest
for the clade C because of its world dominance, especially in countries under
development like Africa, India and Asia.
MYMETICS'S APPROACH
Mymetics proposes an innovative AIDS vaccine that could prevent or reduce HIV
entry at the mucosal level (primary entry: early event) as well as preventing
cell infection by HIV (late event). To achieve this goal, Mymetics has combined
three important concepts in the vaccine design for eliciting different sets of
antibodies:
3
1- Preferential induction of mucosal antibodies for protecting various
anatomical compartments
Mymetics postulates that the induction of protective mucosal antibodies such as
IgA and secretory IgA might block the early event of HIV entry across the
genito-reproductive and intestinal tracts. These mucosal antibodies could also
contribute to prevent the HIV infection of target cells located just under the
mucosal epithelium, thus preventing HIV entry and spreading in the body.
Neutralizing blood antibodies (systemic) such as IgG will also be elicited by
Mymetics's vaccine candidate. These blood antibodies will likely act on later
events that may take place into secondary lymphoid organs, which consist to
prevent the infection of target cells in the periphery, outside of the mucosal
system. These mucosal (mostly IgA) and blood (mostly IgG) antibodies should act
synergistically for optimal protection against HIV transmission and they may
circulate from one compartment to another one, especially blood antibodies
migrating to the mucosa levels.
2- Focused antibody response against relevant conserved gp41 regions
To achieve this objective, Mymetics's HIV vaccine candidate is constituted of
gp41 peptides and recombinant proteins that are devoid of immunodistractive and
useless areas. Generally, the immune system develops immune responses toward all
possible regions of the foreign antigens (peptides, proteins, etc.). However,
antigens are often harbouring several immunodominant regions, each eliciting an
immune response of different magnitude (low, intermediate or strong
recognition/affinity by the immune system) and frequency (region rarely,
sometimes or often recognized by the immune system). Therefore, it is common to
observe an immune response that preferentially recognizes some protein areas
(immunodominant), while others are neglected. Furthermore, viruses have
developed antigens that contain often immunodominant regions for distracting the
immune system. These immunodistractive regions may have little or no function
for the pathogen protein but may blind the immune system. Consequently, immune
responses against the pathogen might be sometimes useless. Mymetics is
developing vaccines that contain different antigens expressing limited and
useful immunodominant regions, while useless immunodistractive regions have been
removed or altered with minimal effect on the immunogenicity of the viral
antigen. Using this approach, it forces the antibody response to focus on
relevant viral protein regions.
3- Minimal mimicry
This concept is intended to remove in part or entirely the human protein
homologies naturally present in many HIV proteins that serve as a vaccine
component. To achieve that objective, Mymetics intends to use as a candidate
vaccine the smallest engineered viral antigen sequence for two main reasons.
First, the smaller the protein, the more limited are the homologies with human
proteins. Second, it is easier to remove human homologies into a small viral
protein or peptide because of their limited distribution. Using this approach,
Mymetics believes that an HIV vaccine constituted of viral antigens or genes
encoding viral antigens with minimal human homologies should reduce the risk of
developing potential long-term autoimmunity side-effects after HIV vaccination.
How to trigger the protective immune response?
Mymetics's vaccine uses the technology of Virosomes(R), a lipid-like structure
highly efficient for delivering the vaccine's active ingredients.
The virosome-based vaccine is constituted of two types of virosomes, each with
surface anchored gp41-derived conserved antigens, each eliciting different
antibodies not mutually exclusive with a broad activity spectrum:
- Virosomes with peptides corresponding to the conserved Membrane
Proximal Region (MPR) of gp41 for triggering protective mucosal
antibodies (mostly IgA) against a broad spectrum of HIV isolates.
- Virosomes with soluble/stable recombinant gp41 without the MPR for
eliciting complementary neutralizing IgA and IgG antibodies.
4
This Virosomes(R) technology is already market approved in more than 40
countries with excellent safety profile and no mucosal adjuvant is required for
triggering mucosal antibodies.
We executed an exclusive License Agreement dated March 1, 2007 with Pevion
Biotech for the use of Virosomes(R) in the production of our HIV vaccine. We
believe that our exclusive agreement with Pevion Biotech provides a competitive
advantage by allowing us to avoid using an adjuvant for our HIV vaccine. We
believe that adjuvants have not sufficiently advanced to allow clinical testing
for our HIV vaccines.
By carefully modifying parts of the HIV gp41 molecule, Mymetics has obtained
vaccine subunits such as gp41 peptides and engineered recombinant gp41 molecules
that:
- May form stable dimers, trimers or tetramers and the protein folding
isclose to the native protein;
- Are soluble in the absence of detergent and can be incorporated into
an artificial lipidic membrane, which is more suitable for in vivo
work;
- Can be chemically synthesized or easily produced by recombinant
bacterialike E. coli;
- Have been stripped of immunodominant areas that generates numerous
non-neutralizing antibodies, which may fool the immune response.
- Have been stripped of its key IL-2-like sequence and other human
homologies, minimizing the important potential cross-reaction with
host proteins that may contribute to the destruction of the immune
system seen in HIV patients;
This type of new engineered gp41 molecules should be able to elicit antibodies
with a broad spectrum of action (cross-clade neutralization like A, B and C):
blocking virus translocation across the mucosal barrier and/or to inhibit cell
infection, thus preventing HIV-1 infection.
Based on our recent research results, we believe that Mymetics's HIV vaccine
candidate and strategies definitely place us amongst the most advanced teams
devoted to AIDS prophylactic vaccine research that aims to prevent HIV
transmission across the mucosal barrier.
Mymetics's findings further apply to a range of additional diseases, including
certain oncoviruses often associated with leukemia.
THE IMMUNE RESPONSE
Normally, the body's immune system responds to the invasion of pathogens. In the
case of HIV, for example, an infected host cell alerts the immune system by
secreting interleukine-2 (IL-2), a special protein (called a cytokine) that acts
as a key messenger for many cells of the immune system.
IL-2 acts as a T cell growth factor, promotes NK proliferation and stimulates B
cell growth (cells that produce antibodies). Together, these "soldier cells"
attack foreign pathogens like viruses, and help to destroy them. From the first
encounter with the invader, the immune system keeps a memory of what happened
and specialized "memory" T and B cells are established as guardians in the
host's body. The next time the invaders try to enter, they will be swiftly
attacked and disarmed.
HIV AND AIDS
The HIV (human immunodeficiency virus) is a retrovirus that gradually destroys
the immune system and ultimately leads to AIDS, is famously the most genetically
diverse viral pathogen known, specially in Africa where HIV is also rapidly
mutating. Indeed, HIV exists under many different versions like members of a
large family, they are different from, but related to each other.
By sequencing the viral genomes (genes), researchers have been able to map out
the family tree of HIV. At the root of the tree, there are three groups called
M, N and
5
O, group M being responsible for the current AIDS pandemic. Group M is split
into nine genetic subtypes, also called nine clades (designated A through K,
with no E or I). The original definition of clades was based on short genomic
sequences, mostly within the HIV envelope protein (Env: gp160).
These nine clades have uneven geographic distribution patterns. Clade C
circulates in South Africa, India and parts of China. Clade A and D are common
in East Africa and clade B is common in North & South America and Western
Europe. Looking at the global numbers, it emerges that four clades (A, B, C and
D) plus two recombinant forms called CRFs 01 and 02 (both of which are about 70%
clade A) account for over 90% of all infections worldwide. From this
perspective, diversity can be mostly limited to 4 key major clades, plus small
contributions from the non-A segments of these two CRFs. According to the
statistics, clade C represents the world's most dominant HIV (>50%).
HIV attaches itself to the target host cell using a harpoon-like surface protein
called gp160. This protein spears the host cell's membrane, drawing them
together so that the virus can fuse with the host cell. Once attached, the virus
penetrates the cell and commandeers the cell's machinery. Then it rapidly
replicates itself.
HIV-1 is lethal since it targets the most central cell of the immune system, the
CD4+ T cells which produce the IL-2 cytokine, a key messenger for immune cells.
These cells usually coordinate the cellular and humoral responses that are
directed to thwart the pathogen (HIV). When the number of such CD4+ T cells
decreases significantly over time, the amount of IL-2 becomes too low for an
efficient immune attack orchestration. Consequently, HIV as well as other
pathogens evade the activity of the immune system, leaving the host vulnerable
to disease.
HIV proves itself an elusive target because it:
- Reproduces itself at an extraordinary rate (several million new virus
particles are created daily)
- Mutates rapidly: as it reproduces itself, it makes mistakes that
produce new virus particles that are slightly different; these
differences make the virus harder to target by the immune system.
MYMETICS AND HIV-AIDS
Normally, the immune system would respond to this attack: IL-2 would be secreted
mostly by activated CD4+ T cells to signal the alarm to the other T-Cells
subtypes and B-cells. With HIV, this approach backfires. Why?
Mymetics has discovered a peculiar inter-reactivity between part of the virus's
"harpoon" and the host cell's "alarm" (IL-2). We call it "mimicry". Several
other homologies between HIV and human proteins have been reported. It has also
been reported that most of HIV infected subjects develop auto-antibodies
(antibodies attacking your own proteins), even in early phase of the infection.
It has been postulated that some mimicries must exist between HIV and human
proteins, which could lead to such autoimmunity problems.
The shaft of the virus' harpoon, called gp41, actually appears to "mimic" the
host cell's IL-2. This dynamic enables the virus to attach itself to the host
cell membrane at a precise portal. An unusual consequence: when the "soldiers"
(antibodies against the viral gp41 protein) arrive to battle the virus, they can
potentially "confuse" the virus's gp41 with the host cell IL-2 and attack and
destroy them both.
As the immune system methodically kills its own soldiers, the HIV continues to
replicate swiftly. The equilibrium shifts and the HIV outpace our body's
defenses. Such events likely contribute to the development of AIDS, a fatal
disease that affects an increasing number of people worldwide. In light of these
reported observations, Mymetics is using this information to develop a safer HIV
vaccine that would be constituted of vaccine subunits having minimal human
homologies.
6
WHERE ARE WE AND WHERE ARE WE GOING?
From 1997 to 2001, Mymetics's R&D has documented the existence of an important
three-dimensional molecular mimicry between the gp41 glycoprotein of HIV-1 and
the human interleukin-2 (IL-2) cytokine, a mimicry also found in lentiviruses
causing AIDS in other animal species. Mymetics has explored this mimicry as the
starting point for developing a safe HIV-1 candidate vaccine capable of
eliciting protective antibodies, while preventing potential harmful
cross-reactivities toward host proteins such as the human IL-2 (Mymetics US
Patent 6,455,265). We believe that this innovative concept may render vaccines
from the 21st century as efficacious as those from the 20th century, in addition
to being safer.
Together with Protein'eXpert S.A. (Grenoble, France), we have succeeded in
engineering and producing in bacteria E. Coli the first gp41 generation in
September 2003, which forms soluble and stable gp41 trimers that closely
resembles the native gp41 found on HIV-1. This first generation of gp41
immunogen is devoid of the cluster I and 2F5/4E10 epitopes, in addition of being
mutated in one important IL-2 mimicry area. The design of the first gp41
generation was intended to identify new important epitopes as well as to focus
the immune response on possible neutralizing epitopes different from the
2F5/4E10 previously identified by other teams.
In 2004, we started a collaboration with Dr. Morgane Bomsel(Cochin Institute,
Paris, France), a renowned scientist in the field of HIV transcytosis and
mucosal immunity. Dr Bomsel had few monoclonal IgA antibodies obtained from a
phage display libraries issued from B cells of HIV resistant women. These
monoclonal IgA antibodies were found later capable of preventing HIV
transcytosis and HIV infection of primary isolates. Interestingly, these IgA
have recognized epitopes on our gp41 first generation devoid of the 2F5/4E10
epitopes, meaning that other potential neutralizing epitopes exist and they are
not limited to IgG isotypes.
From January to August 2004, the first gp41 generation was tested in rabbits for
it's capacity to elicit neutralizing antibodies toward HIV-1. Such antibodies
were obtained in large quantities and their neutralizing potential was evaluated
by our academic collaborators. Thus, Dr. Morgane Bomsel obtained 60% inhibition
of HIV-1 transcytosis with primary strains. Sera were also tested in the
laboratory of Dr Christiane Moog (Institut Pasteur, Strasbourg, France), a well
acclaimed specialist in neutralizing antibodies in the HIV field. In the
performed assay, primary T cells infection by primary HIV-1 strains from clade B
(Bx-08 and SF-162) and clade C (TV1) were respectively neutralized at 70%, 80%
and 90% by low sera dilutions. When total rabbit antibodies were purified from
the serum, a neutralizing activity of 80% was obtained with an antibody
concentration of 20ug/ml, using three primary HIV-1 strains. These results are
similar to those obtained with the 2F5 monoclonal antibody (>90% inhibition),
one of the most potent neutralizing antibodies so far identified. Infection of
primary human macrophages by primary HIV-1 strains was also strongly inhibited
(>90%) with a low antibody concentration (<2ug/ml). These preliminary results
were highly encouraging, considering that the first gp41 generation of immunogen
did not include the 2F5/4E10 epitopes.
A second gp41 generation that has included the 2F5 and 4E10 epitopes was
obtained in August 2004 and produced on a larger scale in September 2004.
However, several technical difficulties were encountered during the production
of this antigen. First, these gp41 proteins formed inclusion bodies in bacteria
that were difficult to solubilize. Gp41 proteins obtained after denaturation and
refolding were forming dimer of trimers instead of the natural trimeric form, as
observed with the gp41 1st generation. Despite of this, these new gp41
immunogens were incorporated into liposomes and were well recognized by the 2F5
and 4E10 monoclonal antibodies kindly provided by Dr Wayne Koff (IAVI), which
suggest the presence of functional epitopes. Rabbit immunizations with
gp41-liposomes have been achieved from Fall 2004 to Winter 2005 and animal sera
were tested. Not surprisingly, this gp41 2nd generation did not elicit
neutralizing antibodies in rabbits, as we initially expected. When mixed with
liposomes, the gp41 2nd generation can form proteo-liposomes that are unstable.
Furthermore, gp41 proteins can bind randomly to liposomes with no preferential
orientation. In such situation, some key epitopes like the 2F5 may not be
properly maintained or presented to the immune system and consequently, these
epitopes are ignored or poorly recognized.
Based on the experience acquired over the first three years (2003-2005), we were
strongly convinced that orienting the anchorage of gp41 proteins or gp41-derived
peptides onto stable synthetic lipid membranes would better present the antigen
to the immune system. Therefore, a third generation of recombinant gp41 proteins
was
7
engineered during Winter-Spring 2005, which lead to the conclusion that not all
epitopes should be present on the same antigenic structure. In fact, to avoid
protein aggregation and to improve the yield of protein production, some
epitopes most be taken separately from others on different antigens. This
approach offers the main advantage to present key epitopes to the immune system,
using different antigens, which should eliminate the problem of epitope
immunodominance. Furthermore, we intend to better target the mucosal immune
system by a more adequate vaccine delivery system: testing nasal administration
alone or in combination with intra-muscular injection.
In parallel to the protein approach, during Winter-Spring 2005 and in
collaboration with Pevion Biotech Ltd. (Bern, Switzerland) and Dr. Bomsel, the
second vaccine prototype has been formulated. This prototype consisted of using
peptides derived from the conserved proximal membrane region of the gp41
ectodomain grafted in an oriented manner onto biosynthetic stable lipidic
spheres called Virosomes(R). Rabbit immunizations (France) were launched from
May to November 2005 for targeting the mucosal immune response. Biological
samples were analyzed and all rabbits have produced specific antibodies toward
the gp41 peptides. More importantly, when these samples were tested into
transcytosis assays, most of these vaginal and rectal secretions (diluted
10-fold for the assay) contained antibodies that were able to prevent
translocation (transcytosis) of primary R5 clades B and C with an efficiency of
70-90%, which is close to what is observed with human secretions isolated from
HIV-resistant women.
This successful rabbit study lead us to another pre-clinical trial in 2006 on
non-human primates (macaques), hoping to reproduce the same results with
virosomes-gp41 peptides. From March to September 2006, sixteen female macaques
(animal facilities in Beijing, China) were immunized four times (40ug/100ul
injected) over 6 months.
- Mymetics's vaccine based on virosomes(R)-gp41 peptides have elicited
mucosal IgA and blood IgG antibodies in >90% of vaccinated macaques.
- These IgA and IgG antibodies could get redistributed into the genital
and intestinal compartments, even in animals vaccinated by
intra-muscular injection in the absence of mucosal adjuvant.
- These antibodies were also capable of preventing at least 60% of HIV
entry across a human mucosal epithelium in vitro and up to 98% in two
out of sixteen animals. Significant inhibitions were obtained with
primary HIV from clades B and C.
- Such success into the macaque animal model, in the absence of mucosal
adjuvant, is a major breakthrough which is highly encouraging for
future human clinical trials.
- Antibodies from secretions will be purified and evaluated for their
potential to neutralize HIV infection.
Following vaccination, macaques will be rectally challenged 5 months later with
SHIV162P3 for measuring the level of protection.
In parallel, we are close to finishing the production of the gp41 4th generation
for clades B and C that will combine the best characteristics of the first three
generations of gp41 previously synthesized. This gp41 will be grafted on
virosomes for being tested during the next pre-clinical trial on non-human
primates. This second pre-clinical trial should be launched in Spring 2007 for
evaluating the vaccine candidate constituting two virosomes: virosomes-gp41
peptides combined with virosomes-rgp41. Mymetics is expecting this HIV vaccine
prototype to trigger the best immune protection. Clinical lots of gp41 peptides
and proteins are planed for Q3 2007, then toxicology and phamacokinetics
evaluations will be conducted. If pre-clinical results are as good as with
induction of mucosal antibodies as the primary end point of the study.
Visit the IAVI web site (www.iavi.org) for more background information on AIDS.
8
VACCINAL USE OF THE MIMICRY DISCOVERY
Our current research modules focus on the following two fields:
PREVENTIVE VACCINES
Mymetics believes that its discovery of the host-virus IL-2 mimicry opens the
door to novel therapeutic and HIV-AIDS preventive vaccine strategies. We are
convinced that properly mutated and engineered trimeric gp41 molecules represent
excellent candidate vaccines because they are devoid of the "IL-2" like
structure and other major human homologies and consequently, its potential
harmful associated auto-immune side effects. Furthermore, these engineered gp41
have conserved their antigenic properties and correspond to the most conserved
region of the viral envelope glycoprotein, which otherwise exhibits considerable
genetic diversity. Mymetics specific preventive vaccine would be "universal" in
that it would train the body's mucosal and blood immune system to recognize and
defeat a broad array of HIV strains, while preventing the potential induction of
the autoimmune reaction toward IL-2. Mymetics recent advances in protein
engineering, peptide designs and mucosal antibody results have kept Mymetics's
vaccine program very competitive.
THERAPEUTIC MOLECULES
Based on insights into mimicry, we have developed a series of synthetic
peptides, based on the well-conserved IL-2 homologous regions, that might
inhibit the fusion between HIV or FIV (the virus causing AIDS in cat) and its
target cell in an infected host. For the in vitro work, these synthetic peptides
have been effective for blocking both HIV and FIV infections, while in vivo
experiments with FIV peptides were investigated until 2003. This application
would complement available antiretroviral drugs, or may even provide a
substitute for the available antiretroviral drugs for FIV and HIV. FIV causes a
disease with a low mortality incidence and the market for such peptides is too
limited and hardly profitable. Therefore, we have decided to cease this research
activity, especially in light of our difficult financial situation. Similarly,
we stopped research on HIV peptides because new compounds were emerging in the
market and we could not remain competitive. However, if our financial situation
improves in a short term, we have the possibility to combine our HIV peptide
technology with another one for creating a new type of drug orally available,
which could become highly attractive.
We currently have compound prototypes potentially capable of commercialization,
including:
- Preventive vaccines - administered to healthy subjects (HIV-negative)
to prevent infection by HIV.
- Therapeutic molecules (pharmacological agents) - administered to
infected subjects to prevent cell infection by HIV and slowing down
the spread of the virus.
Visit our web site www.mymetics.com for more detailed information on our
technology platform.
INTERNATIONAL AIDS VACCINE INITIATIVE (IAVI)
Visit the IAVI site (www.iavi.org)for more background information on AIDS or
download the IAVI Global Report (pdf format) which has a great deal of useful
information about AIDS, vaccines and other related issues in a few easy-to-read
pages at (www.iavi.org/pdf/globalscience.pdf).
RESEARCH AND DEVELOPMENT EXPENSES
INTELLECTUAL PROPERTY
We are the exclusive owner of intellectual property relating to our core
business which is focused on the development of novel HIV-AIDS preventive
vaccines and therapeutics. Particularly, we have:
- Two issued French patents FR99 06528 and FR01 15424 on IL-2 mimicry.
- One European issued patent EP1034000 on IL-2 mimicry.
9
- One U.S. issued patent US 6,455,265 on gp41 & IL-2 mimicry and its
corresponding national filings and divisional filings in various
countries including Europe, the United States, Japan, Canada and
Israel.
- Filed two patents under the Patent Cooperation Treaty, or PCT:
- WO 03/048187 (PCT/US02/38152 filed on November 27, 2002 for
peptides rich in tryptophane as inhibitors of HIV infection from
PFS).
- WO 03/104262 (PCT/US03/18251 filled on June 10, 2003 for
describing gp41 peptides or proteins to block HIV
fusion/infection), with national phases in the United States and
EP.
- We have additionally filed four United States provisional applications
related to the field.
- On July 29, 2004, we applied for a new PCT (PCT/IB2004/002433 or
WO2005010033) which covers our mutated, trimeric, stable recombinant
gp41 protein.
- On May 2, 2005, we applied with INSERM for a new PCT
(PCT/IB05/001182), which covers the description of IgA antibodies
against our recombinant gp41 protein.
- On March 3, 2006, we applied with INSERM and Pevion for a new PCT
which covers our latest prototype HIV-AIDS preventive vaccine based on
the usage of the virosome technology with HIV peptides and proteins.
We rely primarily on a combination of patent, copyright, trademark and trade
secret laws, as well as contractual restrictions, to protect our intellectual
property. These legal protections afford limited protection. We generally
require employees, strategic research partners and consultants with access to
our intellectual property to execute confidentiality agreements. Despite our
efforts to protect our intellectual property, unauthorized parties may attempt
to copy the research and research methods that form the basis of our
intellectual property. The laws of many countries do not afford the same level
of protection as those provided by United States intellectual property laws.
Litigation may be necessary to protect and enforce our rights in our
intellectual property.
COMPETITION
We have not yet developed an actual product or generated any revenues. Our
future competitive position depends on our ability to successfully develop our
intellectual property, and to license or sell such intellectual property to
third parties on financially favorable terms. Although we believe that the
results of our research and development activities have been favorable, there
are numerous entities and individuals conducting research and development
activities in the area of human biology and medicine all of which could be
considered competitors. We are conducting research aimed at developing a
"universal" preventive vaccine that could elicit protective mucosal and blood
antibodies against HIV, with a primary interest for the clade C because of its
world dominance. Our vaccine shall provide protection against a broad array of
viral HIV-1 strains from different clades such as A, B, C and D.
In the field of HIV vaccines, the failure in 2003 of the VAXGEN product in Phase
III clinical trials underscores the need for an effective solution to the global
challenge posed by HIV. As this particular candidate was based on technology
unrelated to our technology, we do not feel that the cessation of clinical
trials with respect to VAXGEN negatively impacts our prospects for developing a
viable preventive vaccine.
The worldwide vaccine market is dominated by four large multinational companies:
Sanofi Pasteur S.A. (formerly Aventis Pasteur S.A.), Merck & Co.,
GlaxoSmithKline Plc, and Novartis-Chiron Inc. Other companies such as Progenics
Pharmaceuticals, Inc., are developing therapeutic HIV vaccines, i.e. vaccines
that target HIV-infected persons in an attempt to control the development of the
disease.
10
While many of these individuals and entities have greater financial and
scientific capabilities, and greater experience in conducting pre-clinical and
clinical trials, we believe that our innovative approach to vaccine development
is very competitive. Our approach is based on three main aspects: 1) design of
lipid membrane anchored-antigens forming dimmers, trimers and tetramers that
force the immune system to focus the response only on key relevant conserved
regions; 2) the induction of protective antibodies not only in the blood but
most importantly in the genito-reproductive and intestinal mucosal compartments
(primary HIV entry site) and; 3) on the observed immunological cross-reactivity
(or mimicry) between the well preserved, antigenic and immunodominant domain of
GP41 and IL-2, and on the observation of expected autoimmune consequences in HIV
infected subjects. Overall, our vaccine candidate will provide an advantage over
existing and future approaches that have been pursued so far because all our
competitors are using DNA, viral vectors, recombinant proteins or peptides with
native viral sequences with no or limited deletion of human sequence homologies
(linear or tridimensional) and poorly induce mucosal immunity. Therefore, all
these vaccine prototypes are potentially harmful on a long-term basis for human
health and do not target properly mucosal tissues. Vaccine candidates under
development of investigation include:
- Sub-unit vaccine: a technology addressing a piece of the outer surface of
HIV, such as GP160, GP140 or GP120, produced by genetic engineering.
- Live vector vaccine: a live bacterium or virus such as vaccinia (used in
the smallpox vaccine) modified so it cannot cause disease, but can
transport into the body one or more genes that makes one or more HIV
proteins.
- Vaccine combination: an example includes a "prime-boost strategy", use of a
recombinant vector vaccine to induce cellular immune responses followed by
booster shots of a sub-unit vaccine to stimulate antibody production.
- Peptide vaccine: chemically synthesized pieces of HIV proteins (peptides)
known to stimulate HIV-specific immunity.
- Virus-like particle vaccine (pseudovirion vaccine): a non-infectious HIV
look-alike that has one or more, but not all, HIV proteins.
- DNA vaccine: direct injection of genes coding for HIV proteins.
- Whole-killed virus vaccine: HIV that has been inactivated by chemicals,
irradiation or other means rendering it non-infectious.
- Live-attenuated virus vaccine: live HIV from which one or more apparent
disease-promoting genes of the virus have been deleted.
GOVERNMENTAL REGULATION
Our strategy was crafted in part to minimize the risks usually associated with
clinical trials, regulatory approvals and marketing, which we would expect to be
borne by one or more future partners.
We contract with third parties to perform research projects related to our
business. These third parties are located in various countries and are subject
to the applicable laws and regulations of their respective countries.
Accordingly, regulation by government authorities in the United States and
foreign countries is a significant factor in the development, manufacture and
marketing of our proposed products by our future partners and therefore has a
direct impact on our ongoing research and product development activities.
Any products that will be developed by our future partners based on our
technology will require regulatory approval by government agencies prior to
commercialization. In particular, human therapeutic products are subject to
rigorous pre-clinical studies and clinical trials and other approval procedures
of the FDA and similar regulatory authorities in foreign countries. In addition,
various federal and state statutes and regulations will also govern or influence
testing, manufacturing, safety, labelling, storage and record keeping related to
such products and their marketing. The process of obtaining these approvals and
the subsequent substantial compliance with appropriate federal and state
statutes and regulations require the
11
expenditure of substantial time and financial resources. Obtaining royalties in
the future will depend on our future partners' ability to obtain and maintain
the necessary regulatory approvals.
Pre-clinical studies generally are conducted on laboratory animals to evaluate
the potential safety and the efficacy of a product. In the United States, we
must submit the results of pre-clinical studies to the FDA as a part of an
investigational new drug application, or IND, which application must become
effective before we can begin clinical trials in the United States. An IND
becomes effective 30 days after receipt by the FDA unless the FDA objects to it.
Typically, clinical evaluation involves a time-consuming and costly three-phase
process. At this time, neither we nor any of our partners has submitted any of
our pre-clinical results to the FDA nor any European or other health regulation
agency. The process which is described below is therefore to be considered as
generic background information which is relevant to the industry as a whole.
Phase I. Refers typically to closely monitored clinical trials and includes the
initial introduction of an investigational new drug into human patients or
normal volunteer subjects. Phase I clinical trials are designed to determine the
metabolic and pharmacologic actions of a drug in humans, the side effects
associated with increasing drug doses and, if possible, to gain early evidence
on effectiveness. Phase I trials also include the study of structure-activity
relationships and mechanism of action in humans, as well as studies in which
investigational drugs are used as research tools to explore biological phenomena
or disease processes. During Phase I clinical trials, sufficient information
about a drug's pharmacokinetics and pharmacological effects should be obtained
to permit the design of well-controlled, scientifically valid, Phase II studies.
The total number of subjects and patients included in Phase I clinical trials
varies, but is generally in the range of 20 to 80 people.
Phase II. Refers to controlled clinical trials conducted to evaluate the
effectiveness of a drug for a particular indication or indications in patients
with a disease or condition under study and to determine the common short-term
side effects and risks associated with the drug. These clinical trials are
typically well-controlled, closely monitored and conducted in a relatively small
number of patients, usually involving no more than several hundred subjects.
Phase III. Refers to expanded controlled clinical trials, which many times are
designated as "pivotal trials" designed to reach end points that the FDA has
agreed in advance, if met, would allow approval for marketing. These clinical
trials are performed after preliminary evidence suggesting effectiveness of a
drug has been obtained. They are intended to gather additional information about
the effectiveness and safety that is needed to evaluate the overall benefit-risk
relationship of the drug and to provide an adequate basis for physician
labelling. Phase III trials can include from several hundred to several thousand
subjects depending on the specific indication being treated.
The FDA closely monitors the progress of each of the three phases of clinical
trials that are conducted in the United States and may, at its discretion,
re-evaluate, alter, suspend or terminate the testing based upon the data
accumulated to that point and the FDA's assessment of the risk/benefit ratio to
the patient. We have not yet conducted any clinical trials and are currently
focused on research. Once Phase III trials are completed, drug developers submit
the results of pre-clinical studies and clinical trials to the FDA, in the form
of an new drug application, or NDA, for approval to commence commercial sales.
In response, the FDA may grant marketing approval, request additional
information or deny the application if the FDA determines that the application
does not meet the predetermined study end points and other regulatory approval
criteria.
Furthermore, the FDA may prevent a drug developer from marketing a product under
a label for its desired indications, which may impair commercialization of the
product.
If the FDA approves the new drug application, the drug becomes available for
physicians to prescribe in the United States. After approval, the drug developer
must submit periodic reports to the FDA, including descriptions of any adverse
reactions reported. The FDA may request additional studies, known as Phase IV
12
trials, to evaluate long-term effects. We will be required to comply with
similar regulatory procedures in countries other than the United States.
In addition to studies requested by the FDA after approval, a drug developer may
conduct other trials and studies to explore use of the approved compound for
treatment of new indications. The purpose of these trials and studies and
related publications is to broaden the application and use of the drug and its
acceptance in the medical community.
Our future partner(s) will have to complete an approval process, similar to the
one required in the United States, in virtually every foreign target market in
order to commercialize product candidates based on our technology in those
countries. The approval procedure and the time required for approval vary from
country to country and may involve additional testing. Approvals (both foreign
and in the United States) may not be granted on a timely basis, or at all. In
addition, regulatory approval of prices is required in most countries other than
the United States. We face the risk that the resulting prices would be
insufficient to generate an acceptable return to our partner(s).
EMPLOYEES
As of December 31, 2006, neither our Luxembourg nor our French affiliates had
any employees.
Mymetics Corporation had three full-time employees: Mr. Christian J.-F. Rochet,
our Chief Executive Officer, Mr. Ernst Luebke, our Chief Financial Officer and
Dr. Sylvain Fleury, Ph.D., our Chief Scientific Officer. Mymetics Corporation
further had one part-time consultant: Professor Marc Girard, DVM, D. SC., our
acting Head of Vaccine Development.
Under their respective employment or consulting agreements, all our officers
have agreed that their salaries, fees and out-of-pocket expenses will only be
paid to them from time to time as the Company's financial position allows. As a
result, Mr. Rochet, Mr. Luebke, Dr. Fleury and Prof. Girard were respectively
owed E45,796, E176,167, E58,601 and E57,053 at December 31, 2006 after having
agreed to convert approximately 50% of their respective claims into Mymetics
common restricted shares at $0.10 per share, the current market price at the
time of the conversion being $0.05 or less.
WWW.MYMETICS.COM
News and information about Mymetics Corporation and its subsidiaries is
available on our web site, www.mymetics.com.
ITEM 1A. RISK FACTORS
You should carefully consider the risks described below together with all of the
other information included in this report on Form 10-K. An investment in our
common stock is very risky. If any of the following risks materialize, our
business, financial condition or results of operations could be adversely
affected. In such an event, the trading price of our common stock could decline,
and you may lose part or all of your investment. When used in these risk
factors, the terms "we" or "our" refer to Mymetics Corporation and its
subsidiaries.
We are a company engaged exclusively in research and development activities,
focusing primarily on human biology and medicine. Our strategy was crafted in
part to minimize the risks usually associated with clinical trials, regulatory
approvals and marketing, which we would expect to be borne by our future
partner(s).
WE HISTORICALLY HAVE LOST MONEY, EXPECT LOSSES TO CONTINUE FOR THE FORESEEABLE
FUTURE AND MAY NEVER ACHIEVE PROFITABILITY.
We historically have lost money. In the year ended December 31, 2006, we
sustained net losses of approximately E1,585,000. In the years ended December
31, 2005 and December 31, 2004, we sustained net losses of approximately
E1,939,000 and E2,202,000, respectively. At December 31, 2006, we had an
accumulated deficit of approximately E15,672,000. Total cash disbursed since
1990 for operating activities, including research and development, is
E10,541,000.
13
The amount of these losses may vary significantly from year-to-year and
quarter-to-quarter and will depend on, among other factors:
- the timing and cost of product development;
- the progress and cost of preclinical and clinical development programs;
- the timing and cost of obtaining necessary regulatory approvals;
- the timing and cost of sales and marketing activities for future products;
and
- the costs of pending and any future litigation of which we may be
subject.
We currently are engaged in research and development activities and do not have
any commercially marketable products. The product research and development
process requires significant capital expenditures, and we do not have any other
sources of revenue to off-set such expenditures. Accordingly, we expect to
generate additional operating losses at least until such time as we are able to
generate significant revenues.
To become profitable, we will need to generate revenues to off-set our operating
costs, including our general and administrative expenses. We may not achieve or,
if achieved, sustain our revenue or profit objectives, and our losses may
increase in the future, and, ultimately, we may have to cease operations.
In order to generate new and significant revenues, we must successfully develop
and commercialize our proposed products or enter into collaborative agreements
with others who can successfully develop and commercialize them. Our business
plan is predicated on commercializing our products in collaboration with others.
Even if our proposed products are commercially introduced, they may never
achieve market acceptance and we may never generate significant revenues or
achieve profitability.
WE NEED TO RAISE SUBSTANTIAL ADDITIONAL CAPITAL TO FUND OUR OPERATIONS AND WE
MAY BE UNABLE TO RAISE SUCH FUNDS ON A TIMELY BASIS AND ON ACCEPTABLE TERMS.
Although we have restructured our existing debt as discussed below, we have not
alleviated our working capital needs. We need to address our working capital
needs by the end of June 2007 to allow us to continue devoting our efforts to
development of the business instead of raising needed capital. If we must devote
a substantial amount of time to raising capital, it will delay our ability to
achieve our business plan within the time frames that we now expect, which could
increase the amount of capital we need and could threaten the success of our
business if competitors are able to produce an effective vaccine to the market
ahead of us. In addition, the amount of time expended by our management on fund
raising distracts them from concentrating on our business affairs.
OUR LIMITED OPERATING HISTORY MAKES IT DIFFICULT TO EVALUATE OR PREDICT OUR
FUTURE BUSINESS PROSPECTS.
We have no operating history, and our operating results are impossible to
predict because we have not begun selling any products. We are in the
development stage, and our proposed operations are subject to all of the risks
inherent in establishing a new business enterprise, including:
- the absence of an operating history;
- the lack of commercialized products;
- insufficient capital;
- expected substantial and continual losses for the foreseeable future;
- limited experience in dealing with regulatory issues;
14
- limited marketing experience;
- an expected reliance on third parties for the commercialization of our
proposed products;
- a competitive environment characterized by numerous, well-established and
well-capitalized competitors;
- uncertain market acceptance of our proposed products; and
- reliance on key personnel.
The likelihood of our success must be considered in light of the problems,
expenses, difficulties, complications, and delays frequently encountered in
connection with the formation of a new business, the development of new
technology, and the competitive and regulatory environment in which we will
operate. See "Description of the Business".
Because we are subject to these risks, you may have a difficult time evaluating
our business and your investment in our company.
OUR PROPOSED PRODUCTS ARE IN THE DEVELOPMENT STAGES AND WILL LIKELY NOT BE
COMMERCIALLY INTRODUCED BEFORE 2010, IF AT ALL.
Our proposed key products still are in the development stage and will require
further development, preclinical and clinical testing and investment prior to
commercialization in the United States and abroad. See "Description of the
Business". While we are pleased about the progress made to date on these
products, we cannot be sure that these products in development will:
- be successfully developed;
- prove to be safe and efficacious in clinical trials;
- meet applicable regulatory standards or obtain required regulatory
approvals;
- demonstrate substantial protective or therapeutic benefits in the
prevention or treatment of any disease;
- be capable of being produced in commercial quantities at reasonable costs;
- obtain coverage and favorable reimbursement rates from insurers and other
third-party payors; or
- be successfully marketed or achieve market acceptance by physicians and
patients.
We do not intend to undertake any product development beyond Phase II human
clinical trials (i.e., Phase III clinical studies) or be responsible for
obtaining regulatory approval or marketing the products. Nevertheless, even if
we are successful in selling or licensing our products to another pharmaceutical
company, it likely that any revenues we may receive in connection with those
arrangements will depend upon that other companies sales, which will, in turn,
depend upon the factors stated above.
NEITHER CHRISTIAN ROCHET, OUR CHIEF EXECUTIVE OFFICER, NOR ERNST LUEBKE, OUR
CHIEF FINANCIAL OFFICER, ARE FULLY PAID FOR THEIR EFFORTS, AND MAY BE FORCED TO
SEEK OTHER EMPLOYMENT ON A FULL TIME OR PART TIME BASIS WHICH COULD ADVERSELY
AFFECT THE COMPANY'S PROSPECTS.
Messrs. Rochet and Luebke are intimately familiar with the business of the
Company, its funding contacts, employees, advisors, consultants and strategic
partners. The inability of the Company to compensate them in accordance with the
amounts due under their respective Employment Agreements could force them for
economic reasons to seek other employment on a part time or full time basis.
Finding people of comparable talent and dedication with the contacts that they
have to persons important to the
15
present and future business of the Company would be difficult given our
inability to pay management the amount of money they are owed and the amount of
money new management would likely demand.
ALTHOUGH WE DO NOT BELIEVE EITHER SYLVAIN FLEURY, OUR CHIEF SCIENTIFIC OFFICER
OR MARC GIRARD, AN IMPORTANT SCIENTIFIC CONSULTANT, HEAD OF OUR VACCINE
DEVELOPMENT PROGRAM, ARE PLANNING TO LEAVE US, REPLACING EITHER OF THESE MEMBERS
OF OUR SCIENTIFIC TEAM WOULD BE DIFFICULT AND WOULD DIMINISH THE COMPANY'S
ABILITY TO ACHIEVE ITS BUSINESS PLAN.
If we are unable to pay Sylvain Fleury's salary, he may soon lose his Swiss
residency permit. Dr. Fleury has been following, and associated with, our AIDS
vaccine project since 1998 and we believe that replacing him as CSO on time for
successfully prosecuting our pending patent applications would be next to
impossible. We are therefore exposed to the risk of losing our pending patent
applications. Similarly, our financial constraints may make it impossible for
Marc Girard to remain as a consultant to us. Given his knowledge of our vaccine
development, losing his services would delay progress on developing and
commercializing our vaccine and may threaten our ability to achieve our business
plan.
OUR BUSINESS MODEL IS PREDICATED ON OUR BELIEF THAT WE WILL BE ABLE TO ENGAGE
LARGE PHARMACEUTICAL COMPANIES TO PARTNER WITH US IN THE DEVELOPMENT OF OUR
PRODUCTS AND FAILURE TO DO SO WILL LIKELY MAKE THE COMPANY UNATTRACTIVE AS AN
ACQUISITION TARGET.
We anticipate that we will need a large pharmaceutical company to assist us with
human trials and financing. See "Funding Requirements". Our failure to succeed
in this endeavor will have a dramatic adverse result regarding our financial
needs and ability to successfully sell any products that we develop.
IF WE FAIL TO OBTAIN REGULATORY APPROVAL TO COMMERCIALLY MANUFACTURE OR SELL ANY
OF OUR FUTURE PRODUCTS, OR IF APPROVAL IS DELAYED OR WITHDRAWN, WE WILL BE
UNABLE TO GENERATE REVENUE FROM THE SALE OF OUR PRODUCTS.
We must obtain regulatory approval to sell any of our products in the United
States and abroad. In the United States, we must obtain the approval of the FDA
for each product or drug that we intend to commercialize. The FDA approval
process is typically lengthy and expensive, and approval is never certain.
Products to be commercialized abroad are subject to similar foreign government
regulation.
Generally, only a very small percentage of newly discovered pharmaceutical
products that enter preclinical development are approved for sale. Because of
the risks and uncertainties in biopharmaceutical development, our proposed
products could take a significantly longer time to gain regulatory approval than
we expect or may never gain approval. If regulatory approval is delayed or never
obtained, our management's credibility, the value of our company and our
operating results and liquidity would be adversely affected. Furthermore, even
if a product gains regulatory approval, the product and the manufacturer of the
product may be subject to continuing regulatory review. Even after obtaining
regulatory approval, we may be restricted or prohibited from marketing or
manufacturing a product if previously unknown problems with the product or its
manufacture are subsequently discovered. The FDA may also require us to commit
to perform lengthy post-approval studies, for which we would have to expend
significant additional resources, which could have an adverse effect on our
operating results and financial condition.
Although we have conducted pre-clinical studies, costly and lengthy human
clinical trials are required to obtain regulatory approval to market our
proposed vaccine, and the results of the trials are highly uncertain. In
addition, the number of pre-clinical studies and human clinical trials that the
FDA requires varies depending on the product, the disease or condition the
product is being developed to address and regulations applicable to the
particular product. Accordingly, we may need to perform additional pre-clinical
studies using various doses and formulations before we can begin human clinical
trials, which could result in delays in our ability to market any of our
products. Furthermore, even if we obtain favorable results in pre-clinical
studies on animals, the results in humans may be different.
After we have conducted pre-clinical studies in animals, we must demonstrate
that our products are safe and effective for use on the target human patients in
order to
16
receive regulatory approval for commercial sale. The data obtained from
pre-clinical and human clinical testing are subject to varying interpretations
that could delay, limit or prevent regulatory approval. We face the risk that
the results of our clinical trials in later phases of clinical trials may be
inconsistent with those obtained in earlier phases. A number of companies in the
biopharmaceutical industry have suffered significant setbacks in advanced
clinical trials, even after experiencing promising results in early animal or
human testing. Adverse or inconclusive human clinical results would prevent us
from filing for regulatory approval of our products. Additional factors that can
cause delay or termination of our human clinical trials include:
- slow patient enrollment;
- timely completion of clinical site protocol approval and obtaining informed
consent from subjects;
- longer treatment time required to demonstrate efficacy or safety;
- adverse medical events or side effects in treated patients; and
- lack of effectiveness of the product being tested.
Delays in our clinical trials could allow our competitors additional time to
develop or market competing products and thus can be extremely costly in terms
of lost sales opportunities and increased clinical trial costs.
EVEN IF OUR PROPOSED PRODUCTS RECEIVE FDA APPROVAL, THEY MAY NOT ACHIEVE
EXPECTED LEVELS OF MARKET ACCEPTANCE, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT
ON OUR BUSINESS, FINANCIAL POSITION AND OPERATING RESULTS AND COULD CAUSE THE
MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Even if we are able to obtain required regulatory approvals for our proposed
products, the success of those products is dependent upon market acceptance by
physicians and patients. Levels of market acceptance for our new products could
be impacted by several factors, including:
- the availability of alternative products from competitors;
- the price of our products relative to that of our competitors;
- the timing of our market entry; and
- the ability to market our products effectively.
Some of these factors are not within our control. Our proposed products may not
achieve expected levels of market acceptance. Additionally, continuing studies
of the proper utilization, safety and efficacy of pharmaceutical products are
being conducted by the industry, government agencies and others. Such studies,
which increasingly employ sophisticated methods and techniques, can call into
question the utilization, safety and efficacy of previously marketed products.
In some cases, these studies have resulted, and may in the future result, in the
discontinuance of product marketing. These situations, should they occur, could
have a material adverse effect on our business, financial position and results
of operations, and the market value of our common stock could decline.
IF WE ARE UNABLE TO PROTECT OUR INTELLECTUAL PROPERTY, WE MAY NOT BE ABLE TO
COMPETE AS EFFECTIVELY.
The pharmaceutical industry places considerable importance on obtaining patent
and trade secret protection for new technologies, products and processes. Our
success will depend, in part, upon our ability to obtain, enjoy and enforce
protection for any products we develop or acquire under United States and
foreign patent laws and other intellectual property laws, preserve the
confidentiality of our trade secrets and operate without infringing the
proprietary rights of third parties.
Where appropriate, we seek patent protection for certain aspects of our
technology. However, our owned and licensed patents and patent applications may
not ensure the protection of our intellectual property for a number of other
reasons:
17
- Competitors may interfere with our patents and patent process in a variety
of ways. Competitors may claim that they invented the claimed invention
before us or may claim that we are infringing on their patents and
therefore we cannot use our technology as claimed under our patent.
Competitors may also have our patents reexamined by showing the patent
examiner that the invention was not original or novel or was obvious.
- We are in the development stage and are in the process of developing
proposed products. Even if we receive a patent, it may not provide much
practical protection. If we receive a patent with a narrow scope, then it
will be easier for competitors to design products that do not infringe on
our patent. Even if the development of our proposed products is successful
and approval for sale is obtained, there can be no assurance that
applicable patent coverage, if any, will not have expired or will not
expire shortly after this approval. Any expiration of the applicable patent
could have a material adverse effect on the sales and profitability of our
proposed product.
- Enforcing patents is expensive and may require significant time by our
management. In litigation, a competitor could claim that our issued patents
are not valid for a number of reasons. If the court agrees, we would lose
protection on products covered by those patents.
- We also may support and collaborate in research conducted by government
organizations or universities. We cannot guarantee that we will be able to
acquire any exclusive rights to technology or products derived from these
collaborations. If we do not obtain required licenses or rights, we could
encounter delays in product development while we attempt to design around
other patents or we may be prohibited from developing, manufacturing or
selling products requiring these licenses. There is also a risk that
disputes may arise as to the rights to technology or products developed in
collaboration with other parties.
It also is unclear whether efforts to secure our trade secrets will provide
useful protection. While we use reasonable efforts to protect our trade secrets,
our employees or consultants may unintentionally or willfully disclose our
proprietary information to competitors resulting in a loss of protection.
Enforcing a claim that someone else illegally obtained and is using our trade
secrets, like patent litigation, is expensive and time consuming, and the
outcome is unpredictable. In addition, courts outside the United States are
sometimes less willing to protect trade secrets. Finally, our competitors may
independently develop equivalent knowledge, methods and know-how.
CLAIMS BY OTHERS THAT OUR PRODUCTS INFRINGE THEIR PATENTS OR OTHER INTELLECTUAL
PROPERTY RIGHTS COULD ADVERSELY AFFECT OUR FINANCIAL CONDITION.
The pharmaceutical industry has been characterized by frequent litigation
regarding patent and other intellectual property rights. Patent applications are
maintained in secrecy in the United States and also are maintained in secrecy
outside the United States until the application is published. Accordingly, we
can conduct only limited searches to determine whether our technology infringes
the patents or patent applications of others. Any claims of patent infringement
asserted by third parties would be time-consuming and could likely:
- result in costly litigation;
- divert the time and attention of our technical personnel and management;
- cause product development delays;
- require us to develop non-infringing technology; or
- require us to enter into royalty or licensing agreements.
Although patent and intellectual property disputes in the pharmaceutical
industry often have been settled through licensing or similar arrangements,
costs associated with these arrangements may be substantial and often require
the payment of ongoing royalties, which could hurt our gross margins. In
addition, we cannot be sure that the necessary licenses would be available to us
on satisfactory terms, or that we
18
could redesign our products or processes to avoid infringement, if necessary.
Accordingly, an adverse determination in a judicial or administrative
proceeding, or the failure to obtain necessary licenses, could prevent us from
developing, manufacturing and selling some of our products, which could harm our
business, financial condition and operating results.
OUR PRINCIPAL OFFICES ARE LOCATED IN SWITZERLAND AND IT MAY BE DIFFICULT FOR YOU
TO ENFORCE JUDGMENTS AGAINST US OR OUR DIRECTORS AND EXECUTIVE OFFICERS.
Although we are a company incorporated under the laws of Delaware, all our
officers and directors are located outside of the United States. As a result, it
may be difficult for investors to effect service of process on those persons in
the United States or to enforce in the United States judgments obtained in
United States courts against those persons based on the civil liability
provisions of the United States securities laws. It may be difficult and costly
for an investor to have a court in Switzerland enforce a judgment obtained in
other jurisdictions, including the United States, against us or our directors or
officers under the securities laws of the United States.
WE HAVE ANTI-TAKEOVER PROVISIONS IN OUR BYLAWS THAT MAY DISCOURAGE A CHANGE OF
CONTROL.
Our bylaws contain provisions that could discourage, delay or prevent a change
in control of our Company or changes in our management that the stockholders of
our company may deem advantageous. These provisions
- limit the ability of our stockholders to call special meetings of
stockholders;
- provide for a staggered board;
- provide that our board of directors is expressly authorized to make, alter
or repeal the bylaws; and
- establish advance notice requirements for nominations for election to our
board or for proposing matters that can be acted upon by stockholders at
stockholder meetings.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
None.
ITEM 2. PROPERTIES
We currently occupy approximately 100 square meters of office space that houses
our administrative operations in Nyon, Switzerland (near Geneva), at 14, rue de
la Colombiere.
Our CSO and his assistant have been using office and other facilities such as
scientific databases access leased on short term basis from the Swiss Institute
of Experimental Cancer Research (ISREC)in Lausanne (20 miles from our Nyon
office).
We also conduct our research operations at the properties of various third
parties, worldwide.
We believe that our current facilities are adequate for our foreseeable needs,
and no additional space presently is necessary. The leases in Nyon and Lausanne
can be terminated at short notice.
ITEM 3. LEGAL PROCEEDINGS
Our present policy is to defend vigorously only the suits with material amounts
being sought in damages and after considering the potential legal costs
involved. We do not currently maintain any insurance but are planning to
conclude one as soon as our financial resources allow it.
Neither Mymetics Corporation nor our wholly owned subsidiary 6543 Luxembourg SA
are presently involved in any litigation incident to our business.
19
Our French subsidiary, Mymetics S.A., is engaged in litigation brought by Dr.
Pierre-Francois Serres, one of our former officers and directors, concerning his
claims of unlawful termination of his employment by former management of our
company. Dr. Serres obtained a judgment from the Lyon Industrial Tribunal for
the full E173,000 in damages that he claimed. On October 26, 2006, the Court of
Appeals of Lyon (France) invalidated the judgment rendered by the Lyon
Industrial Tribunal. Dr. Serres has appealed the decision of the Court of
Appeals of Lyon. Should Dr. Serres be unsuccessful in his appeal, which we
expect based upon advice of our French counsel, he will have to reimburse
approximately E33,000 that he had previously been able to garnish from our bank
account following the judgment of the Lyon Industrial Tribunal. We intend to
vigorously pursue this matter until fully resolved.
As disclosed in our Form 8-K dated February 13, 2006, Mymetics S.A. was placed
under receivership ("Redressement Judiciaire") on February 7, 2006 by the
Tribunal de Commerce in Lyon, France, as a result of an ongoing dispute between
Mymetics Corporation and Dr. Serres, discussed above. The court appointed two
judges to oversee the case, a lawyer to represent the creditors and a judicial
administrator to manage Mymetics S.A., all of whom are considered agents of the
court. The court further imposed a "two-month observation period" during which
management and the administrator should strive to find a solution to the crisis,
which we are attempting to do. On April 4, 2006, the court extended the
observation period until July 18, 2006, based on a favorable report about the
future of Mymetics delivered by the judicial administrator, which date has been
extended to May 7, 2007. We are actively working on a plan which we expect will
allow our French subsidiary to emerge from "Redressement Judiciaire" on or about
that date.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
20
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
(a) The Corporation's trading symbol changed from ICHR to MYMX in July
2001, pursuant to a corporate name change from ICHOR Corporation to Mymetics
Corporation.
(b) Market Information. The Corporation's common stock was quoted on
the OTC Bulletin Board under the trading symbol "MYMX" until December 30, 2005
when it was moved to the "Pink Sheet" market (trading symbol "MYMX.PK") due to
our inability to file in a timely manner our report on Form 10-Q for the period
ended September 30, 2005 with the Securities and Exchange Commission. We have
filed timely periodic reports since that time. We are now in the process of
having a market maker submit a Form 211 to the NASD to have us listed for
quotation on the OTCBB.
(c) The following table sets forth the quarterly high and low sales
price per share of the Corporation's common stock for the periods indicated. The
prices represent inter-dealer quotations, which do not include retail mark-up,
mark-down or commission and may not necessarily represent actual transactions.
FISCAL QUARTER ENDED HIGH LOW
-------------------- ------ ------
2005
March 31............ $ 0.18 $ 0.31
June 30............. 0.045 0.25
September 30........ 0.045 0.08
December 31......... 0.035 0.14(*)
2006
March 31............ $0.070 $0.060
June 30............. 0.028 0.025
September 30........ 0.025 0.025
December 31......... 0.026 0.026
(*) at December 30, 2005, last day of OTC trading
(d) Stockholders. At March 19, 2007, the Corporation had approximately
630 holders of record of its common stock, some of which are securities clearing
agencies and intermediaries.
(e) Dividends. The Corporation has not paid any dividends on its
common stock and does not anticipate that it will pay any dividends in the
foreseeable future.
(f) Securities Authorized for Issuance Under Equity Compensation
Plans.
EQUITY COMPENSATION PLAN INFORMATION
The following table provides information about the common stock that may be
issued upon the exercise of options, warrants and rights under all of our
existing equity compensation plans as of December 31, 2006.
21
Number of Securities to be Weighted Average Exercise Number of Securities remaining
issued upon exercise of Price of Outstanding available for issuance under
Options, Warrants and Options, Warrants and equity compensation plans(excluding
Rights Rights securities reflected in column (a))
Plan Category (a) (b) (c)
------------- -------------------------- ------------------------- -----------------------------------
Equity Compensation Plans
Approved by Security Holders (1) 455,000(2) U.S. $0.97 4,557,500
Equity Compensation Plans not
Approved by Security Holders --(3) N/A
------- ---------- ---------
Total 455,000 U.S. $0.97 4,557,500
======= ========== =========
22
(1) Equity compensation plans approved by our security holders include (i) our
1994 Amended and Restated Stock Option Plan, (ii) our 1995 Qualified
Incentive Stock Option Plan and (iii) our 2001 Stock Option Plan. Our 1994
Amended and Restated Stock Option Plan and our 1995 Qualified Incentive
Stock Option Plan were both terminated in March 2001, but some options
granted under these plans prior to such termination remain outstanding and
are, therefore, included in this table.
(2) Includes (i) 442,500 shares of common stock underlying options granted
under our 2001 Stock Option Plan and (ii) 12,500 shares of common stock
underlying options granted under our 1994 Amended and Restated Stock Option
Plan.
(3) We do not have any formal equity compensation plan that has not been
authorized by our stockholders. These grants are made on an individual
basis and are approved by our board of directors. Accordingly, there are no
shares of common stock reserved for issuance under these arrangements.
ISSUANCES OF UNREGISTERED SECURITIES
Set forth below is information regarding our sales of unregistered
securities during the period commencing on January 1, 2003 and ending on March
19, 2007. These issuances were made pursuant to individual contracts that are
discrete from one another and in reliance on the exemption from registration
provided by Section 4(2) of the Securities Act of 1933, and/or Regulation D
promulgated under the Securities Act, as transactions by an issuer not involving
any public offering to persons who are sophisticated in such transactions and
who had knowledge of and access to sufficient information about Mymetics to make
an informed investment decision. Among this information was the fact that the
securities were restricted securities.
- On January 12, 2006, we issued MFC Merchant Bank SA 2,500,000 shares as fee
for the restructuring of its E3.7 million loan.
- On January 30, 2006, we issued one bank and one individual 50,000 shares
each as fee for introduction services at $.035 per share.
- On January 30, 2006, we issued a previous investor 4,000,000 common shares
of Mymetics Corporation for $200,000, or $.05 per share.
- On January 30, 2006, we issued two previous investors 50,000 common shares
of Mymetics Corporation each as introduction fee, market price being $.035
per share on that date.
- On March 6, 2006, we issued another previous investor 1,500,000 common
shares of Mymetics Corporation for $60,000, or $.04 per share.
- On March 7, 2006, we issued another previous investor 2,750,000 common
shares of Mymetics Corporation for $110,000, or $.04 per share.
- On March 13, 2006, we issued another previous investor 1,500,000 common
shares of Mymetics Corporation for $60,000, or $.04 per share.
- On April 1, 2006, we issued two previous investors 50,000 common shares of
Mymetics Corporation each as introduction fee, market price being $.055 per
share on that date.
- On April 4, 2006, we issued one previous investor 300,000 common shares of
Mymetics Corporation for $6,000, or $.02 per share.
- On April 24, 2006, we issued the same investor 300,000 common shares of
Mymetics Corporation for $12,000, or $.04 per share.
- On May 15, 2006, we issued another investor 2,350,000 common shares of
Mymetics Corporation for E100,000, or approximately $.055 per share.
- On May 31, 2006, we issued a previous investor and lender 1,000,000 common
shares of Mymetics Corporation for the conversion of a $50,000 convertible
23
note, or $.05 per share.
- On July 7, 2006, we issued a new investor 2,600,000 common shares of
Mymetics Corporation for $130,000, or $.05 per share.
- On July 21, 2006, our officers agreed to convert approximately 50% of the
amounts due to them as unpaid salaries, fees and expenses against a total
of 3,500,000 common shares of Mymetics Corporation for an aggregate amount
of $350,000, or $.10 per share, market price being $0.05 on that date.
- On November 7, 2006, we issued a previous investor 1,300,000 common shares
of Mymetics Corporation for E100,000, or approximately $.10 per share.
- On November 9, 2006, we issued another previous investor 1,280,000 common
shares of Mymetics Corporation for E100,000, or approximately $.10 per
share.
- On November 21, 2006, we issued one individual 300,000 shares each as fee
for services at $.025 per share.
- On December 21, 2006, we issued a previous investor 1,320,000 common shares
of Mymetics Corporation for E100,000, or approximately $.10 per share.
- On December 21, 2006, we issued another previous investor 1,320,000 common
shares of Mymetics Corporation for E100,000, or approximately $.10 per
share.
- On December 21, 2006, we issued a new investor 330,000 common shares of
Mymetics Corporation for $33,000, or $.10 per share.
- On January 25, 2006, we issued a previous investor 650,000 common shares of
Mymetics Corporation for E50,000, or approximately $.10 per share.
- On January 31, 2007, we issued a previous investor 300,000 common shares of
Mymetics Corporation at $.035 per share, as initial fee for fund raising
services to be rendered.
- On January 31, 2007, we issued a new investor 200,000 common shares of
Mymetics Corporation at $.035 per share, as initial fee for fund raising
services to be rendered.
- On January 31, 2007, we issued a previous investor 250,000 common shares of
Mymetics Corporation at $.035 per share, as fee for services rendered.
- On January 31, 2007, we issued a new investor 250,000 common shares of
Mymetics Corporation at $.035 per share, as fee for services rendered.
- On February 5, 2007, we issued a previous investor 1,420,000 common shares
of Mymetics Corporation for E110,000, or approximately $.10 per share.
- On February 8, 2007, we issued a new investor 325,000 common shares of
Mymetics Corporation for $32,500, or $.10 per share.
- On March 19, we issued a previous investor 8,712,000 common shares of
Mymetics Corporation for E990,000, or approximately $.15 per share.
- On March 19, 2007, we issued 12,500,000 common shares of Mymetics
Corporation in connection with a settlement of our litigation against MFC
Merchant Bank S. A. ("MFC"), KHD Humboldt Wedag International, Ltd. (fka
MFC Bancorp, Ltd.), the parent company of MFC, and certain prior and
present officers of MFC. See "Liquidity and Capital Resources" under
"Management's Discussion and Analysis of Financial Condition and Results of
Operations".
24
ITEM 6. SELECTED FINANCIAL DATA
The following table reflects selected consolidated financial data for the
Corporation for the fiscal years ended December 31, 2006, 2005, 2002, 2001 and
2000, respectively.
FOR THE FOR THE FOR THE FOR THE FOR THE
YEAR YEAR YEAR YEAR YEAR
ENDED ENDED ENDED ENDED ENDED
DEC 31, DEC 31, DEC 31, DEC 31, DEC 31,
2006, 2005 2004 2003 2002
------- ------- ------- ------- -------
(EUROS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
OPERATING DATA
Operating revenues 0 0 0 0 8
Research & Development
Expenses 543 489 612 1,263 1,878
General & Administrative
Expenses 723 1,138 1,264 1,090 1,293
Loss from continuing
Operations 1,585 1,939 2,202 2,786 (3,622)
COMMON SHARE DATA(1)
Loss from continuing
operations per common
share (0.02) (0.03) (0.04) (0.05) (0.07)
Weighted average common
shares outstanding
(in thousands) 99,716 71,972 62,145 51,285 50,046
BALANCE SHEET DATA
Working capital (6,538) (6,051) (2,035) (4,294) (2,306)
Total assets 360 166 192 367 477
Long-term obligations 242 281 3,110 242 242
Total stockholders'
equity (6,480) (6,280) (5,065) (4,400) (2,349)
(1) Basic and diluted common share data is the same.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
GENERAL
The following discussion and analysis of the results of operations and financial
condition of Mymetics Corporation for the years ended December 31, 2006, 2004
and 2002 should be read in conjunction with the Corporation's audited
consolidated financial statements and related notes and the description of the
Company's business and properties included elsewhere herein.
RESULTS OF OPERATIONS - YEAR ENDED DECEMBER 31, 2006 COMPARED TO YEARS ENDED
DECEMBER 31, 2005 AND DECEMBER 31, 2004
We did not achieve any revenue for the years ended December 31, 2006 or December
31, 2005. Our lack of revenue is directly attributable to our focus on research
and development. The Company predicts that this focus will continue for the
foreseeable future, but we are unable to predict future economic conditions at
the time that our products are ready to be commercialized by our future
partners(s), as described elsewhere in this document. Future revenues could be
affected by local and other economic conditions, technology, competitive forces,
and/or challenges to the Company's intellectual property.
Costs and expenses decreased to E1,585,000 for the year ended December 31, 2006
from E1,939,000 for the year ended December 31, 2005, a decline of 18.3%. Costs
and expenses decreased to E1,939,000 for the year ended December 31, 2005 from
E2,202,000 for the year ended December 31, 2004, a decline of 11.9%.
Research and development expenses increased to E543,000 in the current period
from E489,000 in the comparative period of 2004, an increase of 11.0%. Research
and development expenses decreased to E489,000 in the period ended December 31,
2005 from E612,000 in the comparative period of 2004, a decline of 20.1%.
25
The decrease of R&D expenses during the year 2005 (following a similar decrease
in 2004) was mostly due to our decision taken in 2003 to adapt our R&D efforts
to our present financial capabilities by i) focusing our efforts on the
development of a preventive human vaccine against HIV-AIDS, an area in which we
believe to have a competitive advantage and which addresses a world crisis of
catastrophic proportion, ii) temporarily suspending our development efforts of
therapeutic human antiviral peptides which, despite showing very encouraging
results, would be facing strong existing competition, iii) suspending the
development of a feline preventive vaccine which, despite being an excellent
model for our mimicry based technology would have only limited commercial
potential and iv) abandoning all development of our feline therapeutic peptides
due to our perception of a weak or non existent commercial potential.
Having thus decided to focus entirely on the development of a preventive vaccine
against HIV-AIDS, we devoted our resources over the years as follows:
- 2004 was a year of development of our key recombinant gp41 vaccine protein,
which induced sizeable expenses,
- 2005 was a consolidation year during which our latest vaccine prototype was
tested on rabbits, which implies limited costs but requires more time to
complete, such time depending on biological factors and not on the amount
of money invested.
- 2006 was the year during which our latest vaccine prototype was tested on
macaques at the facilities of the Institute of Laboratory Animal Science of
the Chinese Academy of medical Sciences and the Faculty of Laboratory
Animal Sciences of the Peking Union Medical College in Beijing (Republic of
China), our Chinese partners, which implies higher costs than our initial
rabbit tests and requires more time to complete, such time depending again
on biological factors and not on the amount of money invested.
General and administrative expenses decreased to E723,000 in the year ended
December 31, 2006 from E1,138,000 in the comparable period of 2005, or 36.5%.
This was mostly due to our continuing efforts at limiting G&A expenses wherever
and whenever possible. While this may sound like a wise move, its effect has
been to severely hamper our ability to operate under normal business conditions.
It has also increased the level of risks under which we operate, as none of our
critical employee or officer has a backup ready to step in should a critical
need arise. We expect to return to normal operating conditions, and in
particular to backup our critical employees and officers, as soon as our
financial conditions will allow us to do so. This decrease in G&A expenses was
achieved despite incurring the costs of our legal suit brought against MFC
Merchant Bank SA, its parent company KHD Humboldt Wedag Ltd and some of their
past and present officers.
General and administrative expenses decreased to E1,138,000 in the year ended
December 31, 2005 from E1,264,000 in the comparable period of 2004, or 10.0%.
This was mostly due to our continuing efforts at limiting G&A expenses wherever
and whenever possible. While this may sound like a wise move, its effect has
been to severely hamper our ability to operate under normal business conditions.
It has also increased the level of risks under which we operate, as none of our
critical employee or officer has a backup ready to step in should a critical
need arise. We expect to return to normal operating conditions, and in
particular to backup our critical employees and officers, as soon as our
financial conditions will allow us to do so. This decrease in G&A expenses was
achieved despite an increase in our officers' credited (but mostly unpaid)
annual salary, from E96,000 in 2004 to E144,000 in 2005, a decision taken to i)
compensate our CEO and CFO for the high level of personal risks taken by
accepting to operate without D&O insurance coverage and ii) to bring their
salaries closer to prevailing market conditions.
CRITICAL ACCOUNTING POLICIES AND MANAGEMENT ESTIMATES
The preparation of consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America
requires management to use judgment in making estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues and expenses, and
related disclosure of contingent assets and liabilities. Certain of the
estimates and assumptions required to be made relate to matters that are
inherently uncertain as they pertain to future events. While management believes
that the estimates and assumptions used were the most appropriate, actual
results could differ significantly from those estimates under different
assumptions and conditions. The following is a description of those accounting
policies believed by
26
management to require subjective and complex judgments which could potentially
affect reported results.
REVENUE RECOGNITION AND RECEIVABLES
As we are a development stage company, we have not generated any material
revenues since we commenced our current line of business in 2001, and we do not
anticipate generating any material revenues on a sustained basis unless and
until a licensing agreement or other commercial arrangement is entered into with
respect to our technology.
However, should we engage in any form of commercial activity, a revenue
recognition and receivables policy according to the following principles would
be implemented:
Revenue related to the sale of products is recognized when all of the following
conditions are met: persuasive evidence of an arrangement exists, delivery has
occurred, the price is fixed or determinable, and collectibility is reasonably
assured. Receivables are stated at their outstanding principal balances.
Management reviews the collectibility of receivables on a periodic basis and
determines the appropriate amount of any allowance. Based on this review
procedure, management has determined that the allowances at December 31, 2006
and 2005 are sufficient. The Company charges off receivables to the allowance
when management determines that a receivable is not collectible. The Company may
retain a security interest in the products sold.
The Company makes estimates of the uncollectibility of its accounts receivable.
The Company analyzes accounts receivable and historical bad debt levels,
customer credit worthiness, and current economic trends when evaluating the
adequacy of the allowance for doubtful accounts. In addition, customers in
bankruptcy are analyzed and estimates are made in connection with the expected
recovery of pre-petition and post-petition claims. The Company's net income is
directly affected by management's estimate of the collectibility of accounts
receivable.
Management believes that adequate controls are in place to ensure compliance
with contractual product specifications, a substantial history of such
performance has been established, and historical returns and allowances have not
been significant. If actual sales returns and allowances exceed historical
amounts, the Company's sales would be adversely affected.
RECENT ACCOUNTING PRONOUNCEMENTS
See Note 1 of Notes to Consolidated Financial Statements for a full description
of recent accounting pronouncements including the respective dates of adoption
and effects on results of operations and financial condition.
BUSINESS PLAN
During the next 12 months, we intend to continue development and
commercialization activities currently underway and to explore new activities.
With respect to our gp41 centered research activities, we intend to continue the
activities currently ongoing. In this regard:
- Mymetics has completed the preliminary testings in rabbits during 2005,
which consisted to elicit neutralizing antibodies upon injection of the
second generation of recombinant, mutated, trimeric gp41 proteins,
involving four laboratories in France. Despite the no or low induction of
neutralizing antibodies with the gp41 second generation, these results were
extremely important and crucial for a better understanding of our HIV
vaccine candidate.
- These results lead Mymetics to produce, purify and characterize the third
generation of gp41, still not optimal but required for testing certain
protein properties and behaviors. We concluded that the best trimeric gp41
protein folding and oriented epitope presentation should be optimal if the
HIV vaccine candidate is constituted not by one single gp41 antigen
harboring all the immunogenic regions (epitopes) of the gp41 protein, but
rather by two gp41 complementary antigens, each presenting different parts
of the proteins: 1) shorter recombinant gp41 proteins and 2) gp41 peptides
that cover the missing regions absent on the rgp41 protein. Each antigen
would target a different set of antibodies that might be produced in
various anatomical compartments such as in the blood and/or at the mucosa
levels. Mymetics has hypothesized that this approach would offer the main
advantage of presenting key epitopes to the immune system, using different
27
antigens, to focus the antibody response on relevant parts of the gp41
proteins and also to avoid the problem of epitope immunodominance, meaning
preferential recognition of one irrelevant region of the gp41 over a
relevant one. For testing its hypothesis, Mymetics has initiated in Spring
2005 rabbit immunizations with a specific gp41 peptide, one of the two
potential gp41 subunits that will constitute Mymetics'HIV final vaccine
candidate. Results obtained at the end of 2005 were extremely encouraging.
Most of rabbits have produced specific mucosal antibodies against the
membrane proximal region of the gp41 and vaginal protection is likely
possible because vaginal secretions were containing IgA antibodies capable
of blocking up to 90% of the virus translocation (transcytosis) of primary
HIV strains from clades B and C across human epitheliums (HIV transmission
model). To evaluate if there is a real level of protection at the mucosa
level (preventing HIV to cross the vaginal epithelium), only macaque study
will allow to answer this question.
- In March 2006, non-human female primates were immunized over six months
with HIV gp41 peptides. We were hoping to reproduce the results obtained in
rabbits. Genital and intestinal mucosa represent the main early entry door
for HIV. Therefore, it is crucial to protect these entrances against HIV by
producing into these compartments protective antibodies. Furthermore, the
intestinal mucosa is the biggest immune organ of the body that can
massively produce mostly IgA but HIV vaccine from the past were inefficient
at triggering antibodies into this anatomical compartment. We believe that
an HIV vaccine that could successfully achieve IgA and IgG production into
both genital and intestinal tracts might open the door to a new
prophylactic vaccine approach efficient at preventing or slowing down HIV
infection.
- Mymetics's vaccine based on virosomes(R)-gp41 peptides have elicited
mucosal IgA and blood IgG antibodies in more than 90% of vaccinated
macaques. These IgA and IgG antibodies could get redistributed into the
genital and intestinal compartments, even in animals vaccinated by
intra-muscular injection in the absence of mucosal adjuvant. Vaccinated
macaques will be challenged in early 2007 with SHIV for evaluating the
level of protection against the virus.
- Mymetics will finish for Q2 2007 the production of its gp41 fourth
generation for clades B and C. Then, a second pre-clinical trial on macaque
is scheduled in 2007, which will test gp41 peptides combined with
recombinant gp41 proteins fourth generation. Mymetics is expecting this HIV
vaccine candidate constituted of the two gp41 antigens to trigger a more
complete and protective antibody immune response at the mucosa and blood
levels.
- Mymetics intends also to initiate, depending on the pre-clinical trial
results on macaques, a phase I clinical trial in Q2 2008 for evaluating
human tolerance and immunogenicity.
The precise timing of the gp41 (and any related) activities over the next 12
months and beyond cannot be predicted with certainty, as they are dependent upon
the timing of completion of research and development milestones and the
requirements of our testing laboratories. For a description of the activities
proposed to be conducted in relation to gp41, see "Description of Business -
Where Are We and Where Are We Going?"
Along with our gp41 research, we continue to explore other complementary
research studies conducive to the further research and development of an HIV-1
vaccine.
As discussed in the section entitled "Description of Business - Mymetics
Corporation," we subcontract our research project modules to best of class
research teams. We pay for and coordinate the work, consolidate the results, and
retain all associated intellectual property. On rare occasions, we execute
partnership agreements with companies offering technologies that can enhance our
products.
As discussed in the section entitled "Description of Business - Government
Regulation," we will contract with third parties to develop future products
based upon our technology, and the process for that product development is
highly regulated.
The first phase involves closely monitored clinical trials and the initial
introduction of an investigational new drug into human patients. We expect to
complete these human clinical phase I trials by the end of 2009 and then to sign
a partnership agreement with a major pharmaceutical company. The agreement most
likely would involve an initial cash payment, followed by a series of payments
associated with specific milestones and, finally, royalties on any sales of end
products.
28
We have initiated discussions under Non Disclosure Agreements with two of the
five major pharmaceutical companies targeted as potential development partners.
We do not expect to generate any revenues from any of our product development
activities or licensing until 2009 at the earliest.
LIQUIDITY AND CAPITAL RESOURCES
The Company had E29,000 cash at December 31, 2006, compared to E70,000 at
December 31, 2005 and no/immaterial cash at December 31, 2004.
As we are a development stage company, we have not generated any material
revenues since we commenced our current line of business in 2001, and we do not
anticipate generating any material revenues on a sustained basis unless and
until a licensing agreement or other commercial arrangement is entered into with
respect to our technology.
Increases in borrowing pursuant to a non-revolving term facility with MFC and
other short term advances provided cash of E618,000 in current year, E425,000 in
the comparative period last year and E241,000 in 2004. The non-revolving term
facility is in the principal amount of up to E3.8 million and was to mature on
December 31, 2006, with partial repayments of E900,000 on June 30, 2006. In
addition, any amount repaid under this facility can be converted at the lender's
option into "Rule 144" restricted common shares of Mymetics Corporation at $0.30
per share. At December 31, 2006, Mymetics had borrowed an aggregate of
E4,021,000 pursuant to this non-revolving term facility. We filed a law suit
against MFC and certain of its prior and present officers and directors in
Delaware and New York contesting the validity of this credit facility. On March
19, 2007 we entered into a Settlement Agreement with MFC, to dismiss with
prejudice the lawsuits in Delaware and New York that Mymetics brought against
MFC, KHD Humboldt Wedag International, Ltd. (f/k/a MFCBancorp., Ltd.), the
parent company of MFC, and certain prior and present officers of MFC, in which
Mymetics had alleged breaches of fiduciary duty, interference with prospective
business relations and civil conspiracy against one or more of the foregoing
parties. On March 19, the Company entered into a settlement agreement related to
this facility. Under the terms of the Settlement Agreement, Mymetics agreed to
pay E1.49 million in cash and to issue 12.5 million restricted shares of its
common stock. No gain or loss was recorded on this transaction. MFC agreed to
terminate the E4.02 million credit facility agreement, ending any further
payments or obligations of Mymetics under the credit facility agreement and
releasing from its blanket security interest all assets of Mymetics, including
Mymetics' intellectual property. The Company also agreed to withdraw its
lawsuits against MFC and certain prior and present officers of MFC.
As of December 31, 2006, we had an accumulated deficit of approximately E15.7
million and we incurred losses of E1,585,000 in the twelve-month period ending
December 31, 2006. These losses are principally associated with the research and
development of our HIV vaccine technologies, research into potential animal AIDS
treatments, and other related research activity. We expect to continue to incur
expenses in the future for research, development and activities related to the
future licensing of our technologies. These losses also include E0 of stock
based compensation. For further information regarding stock-based compensation
and other amounts paid to officers, directors, affiliates and their immediate
family members, see the section of this report entitled "Executive
Compensation."
Accounts payable of E1,933,000 at December 31, 2006, include E338,000 due to our
officers as unpaid salaries, fees and out-of-pocket expenses and E1,595,000
representing various monthly bills for operating expenses paid to unrelated
third parties, including utility bills, equipment servicing, laboratory
expenses, plant and office expenses, and professional fees. Payable to
Shareholders of E242,000 at December 31, 2006, represents various amounts
advanced by our founder, Dr. P.-F. Serres, to Hippocampe S.A. (now Mymetics
S.A., our French affiliate) between 1990 and 1999. These advances are
reimbursable subject to the French legal concept of "retour a meilleure fortune"
or "return to better times". This ambiguous concept has been contractually
defined in November 1998 between Dr. Serres and Aralis Participations S.A., then
a major shareholder of Hippocampe S.A., as essentially a positive working
capital ratio of 1.2 during four consecutive quarters, said ratio to be computed
exclusively on the basis of commercial revenues for Hippocampe S.A., i.e. to the
exclusion of subsidies, whether from related or unrelated parties. As a result
of having put our French subsidiary in receivership (see Item 3. Legal
Proceedings), Dr. Serres has made it almost impossible for Mymetics SA to ever
return to "better times".
29
Net cash used by operating activities was E1,359,000 for the year ended December
31, 2006, compared to E561,000 for the year ended December 31, 2005 and
E1,241,000 for the year ended December 31, 2004. The major factor in 2006 was a
decrease of accounts payable of E162,000 compared to successive increases in
accounts payable, which provided cash of E604,000 and E259,000 for the years
ended December 31, 2005 and 2004 respectively.
Investing activities used cash of E300,000 for the year ended December 31, 2006
and used/provided immaterial cash for the years ended December 31, 2005 and
2004.
Financing activities provided cash of E1,614,000 for the year ended December 31,
2006 compared to E781,000 in the same period last year and E928,000 in 2004.
Proceeds from issuance of common stock provided cash of E996,000 for the year
ended December 31, 2006 compared to E356,000 in the same period in 2004 and
E687,000 during the year 2004.
Our budgeted cash outflow, or cash burn rate, for 2007 is approximately
E7,647,000 for research and fixed and normal recurring expenses, as follows,
assuming we will be able to obtain the necessary financing:
12 Months
----------
2007 budget
GMP & Human Clinical Trial Phase I E4,445,000
Vaccine R&D 736,000
Administration 2,016,000
Old Debts (from previous Management) 430,000
Special Projects 20,000
----------
Total E7,647,000
==========
We expect that the cash outflow may increase significantly in 2007 over 2006 as
the Company increases its research and development activities, and prepares for
additional research, human clinical trials and compliance duties associated with
the signing of a partnership agreement with a major pharmaceutical company.
Administration costs include E756,000 in gross salaries and related payroll
costs for three of our executive officers, and payments under consulting
contract with one of our officers. In addition, E360,000 are earmarked for the
payment of the backlog due to our officers. We do not pay our non-employee
directors, and we credit our three salaried executive officers a combined amount
of E54,000 per month.
As of March 31, 2007, we had three full-time salaried executives, exclusive of
our contract for the consulting services of our Head of Vaccines Development.
Certain secretarial and administrative work for our CEO and CFO is outsourced to
self-employed assistants who accept being partially paid in common stock of
Mymetics at the current market price. We anticipate to hire these assistants on
a part time basis as soon as the required financing will become available.
We anticipate hiring an assistant to our CFO as well as a part-time laboratory
technician in the first half of 2007, and may need to hire additional personnel
in order to meet the needs and demands of any future workload.
Monthly fixed and recurring expenses for "Property leases" of E1,000 represents
the monthly sublease and maintenance payments to unaffiliated third parties
under a sublease contract for our executive offices located at 14, rue de la
Colombiere in Nyon (Switzerland) (600 square feet), which can be cancelled on
one month notice. After the principal tenant cancelled his lease as of December
31, 2006, we were able to take over a direct lease for the whole office surface
(approx. 1000 square feet) at a very favorable cost for the area (E1,200 since
January 1, 2007). We further leased 500 square feet for
30
our CSO on the campus of the Swiss Institute of Experimental Cancer Research
(ISREC) in Lausanne (Switzerland), located 20 miles from our Nyon office.
Included in Administration costs are E182,000 estimated recurring legal fees
paid to outside corporate counsel and ongoing litigation expenses, E57,000 audit
and review fees paid to our independent accountants, and E30,000 in investor
relations expenses.
We intend to continue to incur additional expenditures during the next 12 months
for additional research and development of our HIV vaccines. These expenditures
will relate to the continued gp41 testing and are included in the monthly cash
outflow described above. Additional funding requirements during the next 12
months may arise upon the commencement of a phase I clinical trial. We expect
that funding for the cost of any clinical trials would be available either from
debt or equity financings, donors and/or potential pharmaceutical partners
before we commence the human trials.
In the past we have financed our research and development activities primarily
through debt and equity financings from various parties.
We anticipate that our operations will require approximately E7.6 million in the
year ending December 31, 2007. We will seek to raise the required capital from
equity or debt financings, donors and/or potential partnerships with major
international pharmaceutical and biotechnology firms. However, there can be no
assurance that we will be able to raise additional capital on satisfactory
terms, or at all, to finance our operations. In the event that we are not able
to obtain such additional capital, we would be required to further restrict or
even cease our operations.
RECENT FINANCING ACTIVITIES
During 2006, our only source of funds was the sale of common restricted shares
to non-US investors under Regulation S of the Securities Act of 1933. The vast
majority is such sales were made at $0.10 per share despite the current market
price being between $0.02 and $0.05. Whenever possible, restricted common stock
was issued at $0.10 instead of cash to pay for services received. In addition to
the scientific work directly financed by Mymetics, the US National Institutes of
Health (NIH) as well as the French "Association Nationale pour la Recherche sur
le SIDA" (ANRS) have carried out pre-clinical animal trials with our prototype
vaccine at their own expenses. It is difficult to estimate the monetary value of
such work, in particular because it is carried out in both institutions' own
research facilities, but we estimate having saved hundreds of thousands of Euros
over what it would have cost us to finance such work out of our own funds.
As in previous years, Mymetics, being a for-profit publicly traded company, was
ineligible to receive donors' funds. Management is presently examining various
strategies to overcome this difficulty.
We anticipate using our current funds and those we receive in the future both to
meet our working capital needs and for funding the ongoing research costs
associated with our gp41 testing. Provided we can obtain sufficient financing
resources, we expect to begin phase I clinical trials in 2008 as our initial
target date of 2007 had to be postponed due to lack of funds. As in the past and
to the extent this research work will not be conducted by institutions such as
the US National Institutes of Health (NIH), the International AIDS Vaccine
Initiative (IAVI) or the Center for HIV/AIDS Vaccine Immunology (CHAVI), we will
subcontract such work to "best of class" research teams.
We do not anticipate that our existing capital resources will be sufficient to
fund our cash requirements through the next three months. We do not have enough
cash presently on hand, based upon our current levels of expenditures and
anticipated needs during this period, and we will need additional funding
through future collaborative arrangements, licensing arrangements, and debt and
equity financings under Regulation D and Regulation S under the Securities Act
of 1933. We do not know whether additional financing will be available on
commercially acceptable terms when needed. If we cannot raise funds on
acceptable terms when needed, we may not be able to successfully commercialize
our technologies, take advantage of future opportunities, or respond to
unanticipated requirements. If we are unable to secure such additional financing
when needed, we will have to curtail or suspend all or a portion of our business
activities and we could be required to cease operations entirely. Further, if we
issue equity securities, our shareholders may experience severe dilution of
their ownership percentage.
31
The extent and timing of our future capital requirements will depend primarily
upon the rate of our progress in the research and development of our
technologies, our ability to enter into a partnership agreement with a major
pharmaceutical company, and the results of future clinical trials.
To date we have generated no material revenues from our business operations. We
are unable to predict when or if we will be able to generate revenues from
licensing our technology or the amounts expected from such activities. These
revenue streams may be generated by us or in conjunction with collaborative
partners or third party licensing arrangements, and may include provisions for
one-time, lump sum payments in addition to ongoing royalty payments or other
revenue sharing arrangements. However, we presently have no commitments for any
such payments.
OFF-BALANCE SHEET ARRANGEMENTS
We do not have any off-balance sheet arrangements.
TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS
PAYMENTS DUE BY PERIOD (THOUSANDS OF EUROS)
AT MARCH 19, 2007
-------------------------------------------
LESS MORE
THAN 1 - 3 3 - 5 THAN
CONTRACTUAL OBLIGATION TOTAL 1 YEAR YEARS YEARS 5 YEARS
---------------------- ----- ------ ----- ----- -------
Long-term debt 500 E0 500 E0 E0
Capital Lease Obligations E0 E0 E0 E0 E0
Operating Lease Obligations E0 E0 E0 E0 E0
Purchase Obligations 575 575 E0 E0 E0
Other Long-Term Liabilities Reflected on
Mymetics Balance Sheet under GAAP E0 E0 E0 E0 E0
---- --- --- --- ---
TOTAL 1075 575 500 E0 E0
==== === === === ===
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk from changes in interest rates which could affect
our financial condition and results of operations. We have not entered into
derivative contracts for our own account to hedge against such risk.
INTEREST RATE RISK
Fluctuations in interest rates may affect the fair value of financial
instruments. An increase in market interest rates may increase interest payments
and a decrease in market interest rates may decrease interest payments of such
financial instruments. We have debt obligations which are sensitive to interest
rate fluctuations. The following tables provide information about our exposure
to interest rate fluctuations for the carrying amount of such debt obligations
as of December 31, 2006 and 2005 and expected cash flows from these debt
obligations.
32
EXPECTED FUTURE CASH FLOW
YEAR ENDING DECEMBER 31, 2006
(IN THOUSANDS)
-------------------------------------------------------------------
CARRYING FAIR
VALUE VALUE 2007 2008 2009 2010 2011 THEREAFTER
-------- ------ ------ ---- ---- ---- ---- ----------
Debt obligations (1).. E4,372 E4,372 E4,021 E351 E-- E-- E-- E--
Debt obligations.(2).. E 851 E 851 E -- E851 E-- E-- E-- E--
(1) Before settlement of our litigation against MFC Merchant Bank S. A.
("MFC"), KHD Humboldt Wedag International, Ltd. (fka MFC Bancorp, Ltd.),
the parent company of MFC, and certain prior and present officers of MFC.
(2) After settlement under which the MFC loan of E4,021 was terminated and a
shareholder loan of E500 maturing on March 19, 2008 was obtained to
partially finance the settlement.
See "Liquidity and Capital Resources" under "Management's Discussion and
Analysis of Financial Condition and Results of Operations"
YEAR ENDING DECEMBER 31, 2005
(IN THOUSANDS)
-------------------------------------------------------------------
CARRYING FAIR
VALUE VALUE 2006 2007 2008 2009 2010 THEREAFTER
-------- ------ ------ ---- ---- ---- ---- ----------
Debt obligations...... E3,754 E3,754 E3,754 E-- E-- E-- E-- E--
33
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements and supplementary data required with
respect to this Item 8, and as identified in Item 14 of this annual report, are
included in this annual report.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
(a) Disclosure Controls and Procedures. As of the end of the registrant's fiscal
year ended December 31, 2006, an evaluation of the effectiveness of the
registrant's "disclosure controls and procedures" (as such term is defined in
Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended
(the "Exchange Act")) was carried out by the registrant's principal executive
officer and principal financial officer. Based upon that evaluation, the
registrant's principal executive officer and principal financial officer have
concluded that as of the end of that fiscal year, the registrant's disclosure
controls and procedures are effective to ensure that information required to be
disclosed by the registrant in reports that it files or submits under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in Securities and Exchange Commission rules and forms.
It should be noted that while the registrant's principal executive officer and
principal financial officer believe that the registrant's disclosure controls
and procedures provide a reasonable level of assurance that they are effective,
they do not expect that the registrant's disclosure controls and procedures or
internal control over financial reporting will prevent all errors and fraud. A
control system, no matter how well conceived or operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system
are met.
(b) Changes in Internal Control over Financial Reporting. During the fiscal year
ended December 31, 2006, there were no changes in the registrant's internal
control over financial reporting that have materially affected, or are
reasonably likely to materially affect, the registrant's internal control over
financial reporting.
ITEM 9B. OTHER INFORMATION
None
34
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERANCE
The number of directors of the Company is established at six.
Our six person board is divided into three classes, designated as Class I, Class
II and Class III. The term of the Class I directors will expire at our 2007
annual meeting of stockholders, the term of the Class II directors will expire
at our 2008 annual meeting of stockholders, and the term of the Class III
directors will expire at our 2006 annual meeting of stockholders. A plurality of
the votes of the shares of our common stock present in person or represented by
proxy at the annual meeting and entitled to vote on the election of directors
are required to elect the directors.
There currently are three vacancies on the Board caused by the resignation of
Dr. Pierre-Francois Serres, who was a Class III director whose term would have
expired at our 2006 annual meeting of stockholders, Dr. Robert Zimmer, who was a
Class II director whose term would have expired at our 2008 annual meeting of
stockholders and Professor Stanley A. Plotkin, who was a Class I director, whose
term would have expired at our 2007 annual meeting of stockholders.
On January 11, 2006, Dr. Sylvain Fleury, Ph. D., our current Chief Scientific
Officer, was elected to fill the vacancy caused by the resignation of Dr.
Serres. The positions left vacant by the resignation of Dr. Robert Zimmer and
Professor Plotkin will be reserved for potential investors and/or candidates
related to the securing of a strategic partner.
The following table sets forth information regarding each of our current
directors and executive officers.
35
EXPIRATION OF TERM
NAME CURRENT POSITION WITH THE COMPANY AGE AS A DIRECTOR
---- -------------------------------------- --- ------------------
Christian Rochet Chief Executive Officer, President 58 2008 (Class II)
And Director (appointed July 31, 2003)
Ernst Luebke Chief Financial Officer, Treasurer, 61 2007 (Class I)
Secretary and Director (appointed
July 31, 2003)
Sylvain Fleury, Ph. D. Chief Scientific Officer (appointed 44 2006 (Class III)
November 3, 2003) and Director
(appointed January 11, 2006)
Marc Girard, DVM, D. Sc. Head of Vaccine Development 70 n/a
(appointed January 15, 2004)
36
CHRISTIAN ROCHET
Mr. Rochet is the Chief Executive Officer and a Director of Mymetics. Prior to
joining Mymetics in July 2003, he had been an independent business consultant on
development and diversification strategies for over 21 years. He became a
shareholder of Hippocampe S.A. (now our subsidiary Mymetics S.A.) in 1997, on
the scientific advice of Dr. Sylvain Fleury, Ph. D., and was a director of that
company between 1999 and 2001. On July 31, 2003, Mr. Rochet was elected as
President and Director, and appointed as Chief Executive Officer of the Company.
ERNST LUEBKE
Mr. Luebke was appointed as our Chief Financial Officer and as a Director on
July 31, 2003. Prior to joining Mymetics, Mr. Luebke spent over 21 years as an
independent international business consultant and was the founder of several
companies active in the medical and biotech sectors. Together with Mr. Rochet,
he became a major shareholder of Hippocampe S.A. (now our subsidiary Mymetics
S.A.) in 1997, and was a director of that company between 1999 and 2001. On July
31, 2003, Mr. Luebke was elected as Director and appointed as Chief Financial
Officer and Treasurer of the Company. Mr. Luebke was further appointed Secretary
of the Company on August 29, 2003.
SYLVAIN FLEURY, Ph.D.
Dr. Fleury was appointed as our Chief Scientific Officer in November 2003 and as
a Director on January 11, 2006. In addition to serving as our Chief Scientific
Officer, Dr. Fleury has maintained until June 2006 his academic research
activity on in heart transplantation at the Department of Experimental Surgery
from the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne,
Switzerland. Dr. Fleury moved to the CHUV in January 1997 where he initially
worked as Assistant to Professor Giuseppe Pantaleo until June 2000, a leading
expert in AIDS. During that time, he studied the immune regeneration of HIV
infected subjects under highly active anti-retroviral therapy. He then moved to
the Division of Cardiology (CHUV) as Project leader for developing new research
activities in gene therapy applied to heart transplantation, in collaboration
with Novartis, and genetic studies involving chemokines and chemokine receptors
in heart rejection. In January 2004, Dr. Fleury moved to the Department of
Experimental Surgery directed by Professor Yann Barrandon, a world leader on
stem cells, for completing its research on lentiviral gene therapy . Dr. Fleury
obtained his B.Sc. in Microbiology in 1985 from the University of Montreal
(Canada), his M.Sc. in Virology in 1988 from the Institut Armand-Frappier
(Laval, Canada) and his Ph.D. in 1992 from the Clinical Research Institute of
Montreal in Canada with Rafick Sekaly. During his Ph.D., Dr. Fleury worked on
the CD4 molecule, which is the primary HIV cellular receptor. From 1993-1996,
Dr. Fleury completed his postgraduate studies in Bethesda (USA) at the NIAID,
National Institutes of Health (NIH), with Dr. Ronald N. Germain, a world
renowned Immunologist. Dr. Fleury is the recipient of several awards and prizes
and has published articles in his field of study in scientific journals with a
high impact such as Science, Cell, Nature, Nature Medicine, Circulation.
MARC GIRARD, DVM, D. SC.
Professor Girard was appointed as our Head of Vaccine Development in January
2004. Prior to joining Mymetics, Professor Girard served as Director General,
Fondation Merieux, in Lyon, France between 2001 and 2003. Between 1999 and 2001,
Professor Girard served as Director, European Research Center for Virology and
Immunology (CERVI), Lyon, France. Professor Girard has also taught as a
professor since 1966, most recently between 1984 and 1999 at the Institut
Pasteur, Paris, France where he also served as the Head of Laboratory of
Molecular Virology, Department of Virology, Institut Pasteur, Paris between 1980
and 1999. During his career, Professor Girard has served the medical community
in a variety of capacities, including as Head, HIV Vaccine Task Force, French
National Agency for AIDS Research (ANRS), Paris between 1988 and 1998, the
Chairman, Department of Virology, Institut Pasteur, Paris between 1997 and 1999
and the Chairman, European Consortium for an HIV Vaccine (EuroVac), Brussels
between 1999 and 2002. Professor Girard received his D.V.M. (Alfort Veterinary
College) in 1960, his D. Sc. (University of Paris) in 1967 and completed a post
doctoral fellow in 1966 through studies with Prof. James Darnell, MIT then
37
Albert Einstein College of Medicine and Prof. David Baltimore and Renato
Dulbecco of the Salk Institute. Professor Girard is also the published author of
several articles in his field of study.
AUDIT COMMITTEE FINANCIAL EXPERT
Our board of directors has appointed two of our directors as members of our
Audit Committee, i.e. Mr. Christian Rochet and Mr. Ernst Luebke and determined
that Mr. Ernst Luebke, who further serves as Mymetics's CFO, qualifies as our
"audit committee financial expert".
CODE OF ETHICS
We have adopted a Code of Ethics that applies to our executive officers,
including our chief executive officer. A copy of the Code of Ethics is filed as
an exhibit to this Form 10-K annual report.
SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE
Section 16(a) of the Securities and Exchange Act of 1934, as amended, requires
our executive officers, directors and persons who own more than 10% of a
registered class of our equity securities to file reports of ownership and
changes of ownership with the SEC within specified due dates. These persons are
required by SEC regulations to furnish us with copies of all such reports they
file. Based solely on the review of the copies of such reports furnished to us,
we believe that, with respect to our fiscal year ended December 31, 2006, all of
our executive officers, directors and 10% stockholders filed all required
reports under Section 16(a) in a timely manner, except as follows: Dr. Serres,
Dr Fleury, Professor Girard, Ms. Reindle and a Swiss bank acting on behalf of
several of its clients.
ITEM 11. EXECUTIVE COMPENSATION
Compensation Committee Report
The Compensation Committee met with management to review and discuss the
Compensation Discussion and Analysis disclosures that follow. Based on such
review and discussion, the Committee recommended to the Board of Directors that
the Compensation Discussion and Analysis be included in this Annual Report on
Form 10-K, and the Board has approved that recommendation.
Compensation Committee
Christian J.-F. Rochet (Chairman)
Ernst Luebke
Compensation Disclosure and Analysis
As a result of our lack of revenues and liquidity, we currently do not pay our
named executive officers their full compensation on a regular basis under the
terms of their employment agreements (discussed below) for their services. Under
their employment agreements, our named executive officers have agreed to defer
their salaries until such time as we are in a position to pay them. In arriving
at the named executive officers' salaries, our objective was to determine a
salary that, if paid, would be competitive in the market for executives of small
pharmaceutical companies.
SUMMARY COMPENSATION TABLE
The following table sets forth for the last three fiscal years information on
the annual compensation earned by our directors and officers.
38
CHANGE IN
PENSION
VALUE AND
NON-EQUITY NONQUALIFIED
INCENTIVE DEFERRED
STOCK OPTION PLAN COMPENSATION ALL OTHER
NAME AND PRINCIPAL AWARDS AWARDS COMPENSATION EARNINGS COMPENSATION TOTAL
POSITION YEAR SALARY (E) BONUS (E) (E) (E) (E) (E) (E) (E)
------------------ ---- ---------- --------- ------ ------ ------------ ------------ ------------ --------
Christian J.-F. Rochet 2006 E216,000(5) -- -- -- -- -- -- E216,000(5)
(PEO) (1) 2005 E144,000(5) -- -- -- -- -- -- E144,000(5)
2004 E 40,000(5) -- -- -- -- -- -- E 40,000(5)
Ernst Luebke (PFO) (2) 2006 E216,000(5) -- -- -- -- -- -- E216,000(5)
2005 E144,000(5) -- -- -- -- -- -- E144,000(5)
2004 E 40,000(5) -- -- -- -- -- -- E 40,000(5)
Sylvain Fleury, Ph. D. 2006 E216,000(5) -- -- -- -- -- -- E216,000(5)
(3) 2005 E144,000(5) -- -- -- -- -- -- E144,000(5)
2004 E 96,000(5) -- -- -- -- -- -- E 96,000(5)
Marc Girard, DVM, 2006 E 48,000(5) -- -- -- -- -- -- E 48,000(5)
D.Sc. (4) 2005 E 48,000(5) -- -- -- -- -- -- E 48,000(5)
2004 E 36,000(5) -- -- -- -- -- -- E 36,000(5)
(1) Mr. Rochet has been our President and Chief Executive Officer since July
31, 2003.
(2) Mr. Luebke has been our Chief Financial Officer and Treasurer since July
31, 2003 and our Secretary since August 29, 2003.
(3) Dr. Fleury has been appointed as our Chief Scientific Officer on November
3, 2003.
(4) Professor Girard has been appointed on January 9, 2004 by our Board of
Directors as Head of Vaccine Development, effective January 15, 2004, under
a part time consulting agreement formally signed on June 9, 2004.
(5) See below "Employment Agreements".
The tables entitled "GRANTS OF PLAN-BASED AWARDS," "OUTSTANDING EQUITY AWARDS AT
FISCAL YEAR-END," "OPTION EXERCISES AND STOCK VESTED," "PENSION BENEFITS,"
"NONQUALIFIED DEFERRED COMPENSATION" and "DIRECTOR COMPENSATION" and the
respective discussions related to those tables have been omitted because no
compensation required to be reported in those tables was awarded to, earned by
or paid to any of the named executive officers or directors in any of the
covered fiscal years.
Employment Agreements
Under the Executive Employment Agreement for Christian Rochet, he is employed as
CEO for five years commencing July 1, 2006. Mr. Rochet receives an annual salary
of E216,000 and is entitled to cash bonuses of 3% of all payments to be received
from industry partners of the Company. If Mr. Rochet is terminated without cause
or he terminates for good reason, he is entitled to a lump-sum payment equal to
the greater of 24 months of his salary or the remaining term of his employment
agreement.
Under the Executive Employment Agreement for Ernst Luebke, he is employed as CFO
for five years commencing July 1, 2006. Mr. Luebke receives an annual salary of
E216,000 and is entitled to cash bonuses of 3% of all payments to be received
from industry partners of the Company. If Mr. Luebke is terminated without cause
or he terminates for good reason, he is entitled to a lump-sum payment equal to
the greater of 24 months of his salary or the remaining term of his employment
agreement.
Under the Executive Employment Agreement for Sylvain Fleury, Ph.D., he is
employed
39
as CEO for five years commencing July 1, 2006. Dr. Fleury receives an annual
salary of E216,000 and is entitled to cash bonuses of 3% of all payments to be
received from industry partners of the Company. If Dr. Fleury is terminated
without cause or he terminates for good reason, he is entitled to a lump-sum
payment equal to the greater of 24 months of his salary or the remaining term of
his employment agreement.
Under their employment agreements, the officers have agreed to defer payment of
amounts due to them until the Company's financial position has been stabilized.
Professor Girard has also agreed to defer payments due to him under his
consulting agreement until the Company's financial position has been stabilized.
As a result, at year end the Company owed Mr. Rochet, Mr. Luebke, Dr. Fleury and
Professor Girard E45,796, E176,167, E58,601 and E57,053, respectively, as salary
and reimbursement of actual travel and other expenses disbursed by them on
behalf of Mymetics.
COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION
All executive officer compensation decisions are made by the Compensation
Committee of the Board. The Compensation Committee reviews and recommends the
compensation arrangements for officers and other senior level employees, and
takes such other action as may be required in connection with the Company's
compensation and incentive plans. From July 31, 2003, the members of the
Compensation Committee were Mr. Rochet, Mr. Luebke, Dr. Serres and Dr. Zimmer,
the latter two until their resignation only, i.e. June 7 and June 13, 2005
respectively. Both of Messrs. Rochet and Luebke were officers and employees of
the Company during the fiscal year.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The following table sets forth information about the beneficial ownership of our
common stock as of March 19, 2007, by: (a) each of our named executive officers;
(b) each of our directors; (c) each person known to us to be the beneficial
owner of more than 5% of our outstanding voting securities; and (d) all of our
current executive officers and directors as a group. The following is based
solely on statements and reports filed with the Securities and Exchange
Commission or other information we believe to be reliable.
There were 135,627,464 shares of our common stock outstanding on March 19, 2007.
We have determined beneficial ownership in accordance with the rules of the
Securities and Exchange Commission. Except as indicated by the footnotes below,
we believe, based on the information furnished to us, that the persons and
entities named in the tables below have sole voting and investment power with
respect to all shares of common stock that they beneficially own, subject to
applicable community property laws.
In computing the number of shares of common stock beneficially owned by a person
and the percentage ownership of that person, shares of common stock subject to
options or warrants held by that person that are currently exercisable or
exercisable within 60 days of March 19, 2007, are deemed outstanding. These
shares of common stock, however, are not deemed outstanding for the purposes of
computing the percentage ownership of any other person.
40
NAME AND ADDRESS OF AMOUNT AND NATURE OF
BENEFICIAL OWNER TITLE OF CLASS BENEFICIAL OWNERSHIP PERCENT OF CLASS
------------------- -------------- -------------------- ----------------
Anglo Irish Bank (Suisse) SA Common 28,602,000(2) 25.84%
7, place des Alpes
CH - 1201 Geneva, Switzerland
Martine Reindle Common 9,022,653(3) 8.15%
CP 18
CH - 1295 Mies, Switzerland
Ernst Luebke (1) Common 5,079,418(4) 4.58%
Chief Financial Officer, Secretary and Director
Dr. Sylvain Fleury (1) Common 1,500,000(5) 1.35%
Chief Scientific Officer
Christian Rochet (1) Common 1,377,138(6) 1.24%
Chief Executive Officer, President and Director
Prof. Marc Girard (1) Common 1,000,000(7) 0.90%
Head of Vaccine Development and member of the SAB
All current executive officers and Common 8,956,556 8.07%
directors as a group (4 persons)
41
----------
(1) Address is Mymetics Corporation, European Executive Office, 14, rue de la
Colombiere, CH-1260 Nyon (Switzerland).
(2) Held on behalf of several bank customers.
(3) Acquired prior to the reverse merger of 2001.
(4) Of which 4,079,418 acquired prior to being elected as director and
appointed as officer and 1,000,000 acquired through conversion of unpaid
salary and expenses.
(5) Of which 500,000 issued for services and 1,000,000 acquired through
conversion of unpaid salary and expenses.
(6) Of which 377,138 acquired prior to being elected as director and appointed
as officer and 1,000,000 acquired through conversion of unpaid salary and
expenses.
(7) Of which 500,000 issued for services and 500,000 acquired through
conversion of unpaid fees and expenses.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
During 2006, there were no transactions, and there are currently no proposed
transactions, to which we were, are or will be a party in which the amount
involved exceeds $120,000 and in which any of our directors, executive officers
or holders of more than 5% of our common stock, or an immediate family member of
any of the foregoing, had or will have a direct or indirect interest.
Furthermore, it is our intention to ensure that all future transactions,
including loans, between us and our officers, directors and principal
stockholders and their affiliates are on terms no less favorable to us than
those that we could obtain from unaffiliated third parties.
COMPENSATION AGREEMENTS
We have entered into compensation arrangements with certain of our directors.
The terms of these arrangements are described in more detail under "Compensation
of Directors".
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The following table provides information about the fees billed to the registrant
for professional services rendered by Peterson Sullivan PLLC during fiscal 2006
and 2005:
2006 2005
------- -------
Audit Fees $42,788 $43,027
Audit-Related Fees -- --
Tax Fees -- 1,649
All Other Fees -- --
------- -------
Total $42,788 $44,676
======= =======
Audit Fees. Audit fees consist of fees for the audit of the registrant's annual
financial statements or services that are normally provided in connection with
statutory and regulatory filings or engagements.
42
Audit-Related Fees. Audit-related fees consist of fees for assurance and related
services that are reasonably related to the performance of the audit or review
of the registrant's financial statements and are not reported as Audit Fees.
During fiscal 2006 and 2005, the services provided in this category included due
diligence reviews, audits of employee benefit funds, and consulting on
accounting standards and transactions.
Tax Fees. Tax fees consist of fees for tax compliance services, tax advice and
tax planning. During fiscal 2006 and 2005, the services provided in this
category included assistance and advice in relation to the preparation of
corporate income tax returns.
All Other Fees. Any other fees not included in Audit Fees, Audit-Related Fees or
Tax Fees.
Pre-Approval Policies and Procedures.
Prior to February 14, 2007, Our Board of Directors pre-approved all services to
be provided by Peterson Sullivan PLLC.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)(1) Index to Financial Statements
Independent Auditors' Report
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Changes in Shareholders' Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(a)(2) ALL OTHER SCHEDULES HAVE BEEN OMITTED BECAUSE THEY ARE NOT
APPLICABLE OR THE REQUIRED INFORMATION IS SHOWN IN THE FINANCIAL STATEMENTS OR
NOTES THERETO.
(3) List of Exhibits
2.1 Share Exchange Agreement dated December 13, 2001 between the
Corporation and the stockholders of Mymetics S.A. listed on the
signature page thereto (1)
2.2 Share Exchange Agreement dated December 13, 2001 between the
Company and the stockholders of Mymetics S.A. listed on the
signature page thereto (1)
2.3 Purchase Agreement dated October 17, 1998 between the Company and
the majority stockholders of Nazca Holdings Ltd. (2)
2.4 Amendment to the Purchase Agreement dated October 17, 1998
between the Company and the majority stockholders of Nazca
Holdings Ltd. (3)
2.5 Revised Purchase Agreement dated July 28, 1999 between the
Company and the majority stockholders of Nazca Holdings Ltd. (4)
2.6 Share Exchange Agreement dated July 30, 2002 between the Company
and the stockholders of Mymetics S.A. listed on the signature
page thereto (5)
43
3(i) Articles of Incorporation of the Company (as amended through May
10, 2002) (6)
3(ii) Bylaws (7)
4.1 Form of Specimen Stock Certificate (8)
4.2 Form of letter regarding Warrant (8)
4.3 Form of Share Exchange Agreement (8)
9.1 Voting and Exchange Trust Agreement dated March 19, 2001, among
the Company, 6543 Luxembourg S.A. and MFC Merchant Bank S.A. (8)
10.1 Services Agreement dated May 31, 2001, between the Company and
MFC Merchant Bank, S.A.(7)
10.2 Employment Agreement dated May 3, 2001, between Pierre-Francois
Serres and the Company (7)
10.3 Indemnification Agreement dated March 19, 2001, between the
Company and MFC Bancorp Ltd. (7)
10.4 Agreement dated for reference May 15, 2000, between the Company
and Maarten Reidel (7)
10.5 Preferred Stock Redemption and Conversion Agreement dated for
reference December 21, 2000, between the Company and Sutton Park
International Ltd. (10)
10.6 Preferred Stock Conversion Agreement dated for reference December
21, 2000, between the Company and Med Net International Ltd. (11)
10.7 Preferred Stock Conversion Agreement dated December 21, 2000,
between the Company and Dresden Papier GmbH (11)
10.8 Assignment Agreement dated December 29, 2000, among the
Company, Mymetics S.A. and MFC Merchant Bank S.A. (1)
10.9 Credit Facility Agreement dated July 27, 2000, between MFC
Merchant Bank, S.A. and the Company (1)
10.10 Amended Credit Facility Agreement dated for reference August
13, 2001, between MFC Merchant Bank, S.A. and the Company
(16)
10.11 Second Amended Credit Facility Agreement dated for reference
February 27, 2002, between MFC Merchant Bank, S.A. and the
Company (16)
10.12 Amended and Restated Credit Facility Agreement dated for
reference February 28, 2003, among MFC Merchant Bank, S.A., MFC
Bancorp Ltd., and the Company (16)
10.13 Guarantee dated for reference February 28, 2003, by MFC Bancorp
Ltd. to MFC Merchant Bank S.A. (16)
10.14 Shareholder Agreement dated March 19, 2001, among the
Company, the Holders of Class B Exchangeable Preferential
Non-Voting Shares of 6543 Luxembourg S.A. signatory thereto and
6543 Luxembourg S.A.(8)
10.15 Support Agreement dated March 19, 2001, between the Company
and 6543 Luxembourg S.A. (8)
44
10.16 1995 Qualified Incentive Stock Option Plan (12)
10.17 Amended 1994 Stock Option Plan (13)
10.18 2001 ICHOR Company Stock Option Plan (7)
10.19 Employment Agreement dated March 18, 2002, between the
Company and Peter P. McCann (14)
10.20 Consulting Agreement dated August 31, 2001, between the
Company and Michael K. Allio (8)
10.21 Amendment to Consulting Agreement dated August 21, 2002,
between the Company and Michael K. Allio (16)
10.22 Employment Agreement dated March 18, 2002, between the
Company and Dr. Joseph D. Mosca (15)
10.23 Separation Agreement and Release dated January 31, 2003,
between the Company and Peter P. McCann (16)
10.24 Director and Non-Employee Stock Option Agreement dated July 19,
2001, between the Company and Robert Demers (8)
10.25 Director and Non-Employee Stock Option Agreement dated July 19,
2001, between the Company and Michael K. Allio (8)
10.26 Director and Non-Employee Stock Option Agreement dated July 19,
2001, between the Company and John M. Musacchio (8)
10.27 Director and Non-Employee Stock Option Agreement dated July 19,
2001, between the Company and Patrice Pactol (8)
10.28 Director and Non-Employee Stock Option Agreement dated July 19,
2001, between the Company and Pierre-Francois Serres (8)
10.29 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and Pierre-Francois Serres (16)
10.30 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and Patrice Pactol (16)
10.31 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and Robert Demers (16)
10.32 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and John M. Musacchio (16)
10.33 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and Michael K. Allio (16)
10.34 Director and Non-Employee Stock Option Agreement dated August
21, 2002, between the Company and Michael K. Allio (16)
10.35 Director and Non-Employee Stock Option Agreement dated June 20,
2002, between the Company and Peter P. McCann (16)
10.36 Director and Non-Employee Stock Option Agreement dated July 23,
2002, between the Company and Peter P. McCann (16)
10.37 Director and Non-Employee Stock Option Agreement dated February
6, 2003, between the Company and Peter P. McCann (16)
10.38 Patent Pledge Agreement dated November __, 2002 among Mymetics
S.A., Mymetics Deutschland GmbH, the Company and MFC
Merchant Bank S.A. (16)
10.39 Third Amendment to the Credit Facility Agreement dated for
Reference December 31, 2006, between MFC Merchant Bank, S.A.
45
and the Company (17)
10.40 Fourth Amendment to the Credit Facility Agreement dated for Reference
February 16, 2005, between MFC Merchant Bank, S.A. and the Company (17)
10.41 Consulting Agreement dated for reference January 1, 2004,
between the Centre Hospitalier Universitaire Vaudois (CHUV),
the Company and Dr. Sylvain Fleury, Ph.D. (18)
10.42 Consulting Agreement dated for reference January 1, 2004,
between the Company and Professor Marc Girard, DVM, D.Sc. (18)
10.43 Cooperation and Option Agreement dated March 10, 2005, between
the Company and Pevion A.G. (18)
10.44 Consulting Agreement dated March 23, 2005, between the
Company and Northern Light International. (18)
10.45 Sixth Amended Credit Facility Agreement dated for reference
December 31, 2005, between MFC Merchant Bank, S.A. and the
Company (19)
10.46 Employment Agreement dated July 1, 2006, between the
Company and Dr. Sylvain Fleury (20)
10.47 Employment Agreement dated July 1, 2006, between the
Company and Christian Rochet (20)
10.48 Employment Agreement dated July 1, 2006, between the
Company and Ernst Luebke (20)
10.49 License Agreement dated March 1, 2007, between the Company and
Pevion Biotech Ltd.
10.50 Loan Agreement dated March 19, 2007, between the Company and Anglo Irish
Bank (Suisse) S.A. (Translation from French language original)
10.51 Settlement Agreement dated March 19, 2007, between the Company
and MFC Merchant Bank S.A. ("MFC Bank"), certain prior and
present officers of MFC Bank and KHD Humboldt Wedag International
Ltd (f/k/a MFC Bancorp Ltd)
11.1 Statement Regarding Calculation of Per Share Earnings.
14.1 Code of Ethics.
21.1 List of Subsidiaries
24.1 Powers of Attorney (included on the signature page hereto)
31.1 Certification of Chief Executive Officer pursuant to Rule
13a-14(a) or 15d-14 of the Securities Exchange Act of 1934
31.2 Certification of Chief Financial Officer pursuant to Rule
13a-14(a) or 15d-14 of the Securities Exchange Act of 1934
32.1 Section 1350 Certification of Chief Executive Officer and Chief
Financial Officer
----------
(1) Incorporated by reference to the Company's Schedule 14C filed with the
Securities and Exchange Commission on April 26, 2001.
(2) Incorporated by reference to the Company's report on Form 8-K filed
with the Securities and Exchange Commission on October 22, 1998.
46
(3) Incorporated by reference to the Company's report on Form 8-K/A filed
with the Securities and Exchange Commission on April 15, 1999.
(4) Incorporated by reference to the Company's report on Form 8-K/A filed
with the Securities and Exchange Commission on August 13, 1999.
(5) Incorporated by reference to the Company's Amendment No. 1 to Form
S-1 filed with the Securities and Exchange Commission on August 8, 2002.
(6) Incorporated by reference to the Company's report on Form 10-Q for the
quarter ended March 31, 2002, filed with the Securities and Exchange
Commission on May 15, 2002.
(7) Incorporated by reference to the Company's report on Form 10-Q for the
quarter ended June 30, 2001, filed with the Securities and Exchange
Commission on August 14, 2001.
(8) Incorporated by reference to the Companys Registration Statement on
Form S-1, File No. 333-88782, filed with the Securities and Exchange
Commission on May 22, 2002.
(9) Incorporated by reference to the Company's report on Form 8-K/A filed
with the Securities and Exchange Commission on August 9, 2000.
(10) Incorporated by reference to Schedule 13D/A filed by MFC Bancorp Ltd. with
the Securities and Exchange Commission on dated January 2, 2001.
(11) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2000, filed with the Securities and Exchange
Commission on March 14, 2001.
(12) Incorporate by reference to the Company's Registration Statement on
Form S-8, File No. 333-15831, filed with the Securities and Exchange
Commission on November 8, 1996.
(13) Incorporated by reference to the Company's Registration Statement on
Form S-8, File No. 333-15829, filed with the Securities and Exchange
Commission on November 8, 1996.
(14) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2004, and filed with the Securities and
Exchange Commission on March 29, 2002.
(15) Incorporated by reference to the Company's report on Form 10-Q for the
quarter ended March 31, 2002, filed with the Securities and Exchange
Commission on May 15, 2002.
(16) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2005, and filed with the Securities and
Exchange Commission on March 27, 2003.
(17) Incorporated by reference to the Company's report on Form 8-K filed
With the Securities and Exchange Commission on February 18, 2005.
(18) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2004, filed with the Securities and Exchange
Commission on March 30, 2005.
(19) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2005, filed with the Securities and Exchange
Commission on April 17, 2006.
(20) Incorporated by reference to the Company's report on Form 10-Q for the
period ended June 30, 2006, and filed with the Securities and
Exchange Commission on August 21, 2006.
(21) Incorporated by reference to the Company's report on Form 8-K filed
With the Securities and Exchange Commission on February 18, 2005.
47
(22) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2004, filed with the Securities and Exchange
Commission on March 30, 2005.
(23) Incorporated by reference to the Company's report on Form 10-K for the
fiscal year ended December 31, 2005, filed with the Securities and Exchange
Commission on April 17, 2006.
(b) Reports on Form 8-K
During our fourth quarter ended December 31, 2006, we did not file any
reports on Form 8-K with the Securities and Exchange Commission.
48
PETERSON SULLIVAN PLLC
601 UNION STREET SUITE 2300
SEATTLE WA 98101
(206) 382-7777 FAX 382-7700
CERTIFIED PUBLIC ACCOUNTANTS
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Shareholders
Mymetics Corporation and Subsidiaries
We have audited the accompanying consolidated balance sheets of Mymetics
Corporation (a development stage company) and Subsidiaries as of December 31,
2006 and 2005, and the related consolidated statements of operations and
comprehensive loss, changes in shareholders' equity (deficit), and cash flows
for each of the years in the three-year period ended December 31, 2006, and for
the period from May 2, 1990 (inception) to December 31, 2006. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company has determined that it
is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audit included consideration of
internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Company's internal control
over financial reporting. Accordingly, we express no such opinion. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of Mymetics Corporation
(a development stage company) and Subsidiaries as of December 31, 2006 and 2005,
and the results of their operations and their cash flows for each of the years
in the three-year period ended December 31, 2006, and for the period from May 2,
1990 (inception) to December 31, 2006, in conformity with accounting principles
generally accepted in the United States.
The accompanying consolidated financial statements have been prepared assuming
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company has not developed a commercially
viable product and, therefore, has not been able to generate revenues, which has
resulted in significant losses being incurred. Further, the Company's current
liabilities exceed its current assets by E6,538,000 as of December 31, 2006, and
there is no assurance that cash will become available to pay current liabilities
in the near term. These conditions raise substantial doubt about the Company's
ability to continue as a going concern. Management's plans regarding these
matters are also described in Note 1. These consolidated financial statements do
not include any adjustments that might result from the outcome of these
uncertainties.
/S/ PETERSON SULLIVAN PLLC
Seattle, Washington
March 23, 2007
49
MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
December 31, 2006 and 2005
(In Thousands of Euros)
2006 2005
-------- --------
ASSETS
Current Assets
Cash E 29 E 70
Receivables 15 42
Prepaid expenses 16 2
-------- --------
Total current assets 60 114
Patents and Licenses 300 52
-------- --------
E 360 E 166
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
Current Liabilities
Accounts payable E 1,933 E 2,095
Taxes and social costs payable 5 15
Current portion of note payable 4,372 3,754
Other 288 301
-------- --------
Total current liabilities 6,598 6,165
Payable to Shareholders 242 242
Note Payable, less current portion -- 39
-------- --------
Total liabilities 6,840 6,446
Shareholders' Equity (Deficit)
Common stock, U.S. $.01 par value;
495,000,000 shares authorized; issued and outstanding
110,690,464 at December 31, 2006 and 76,043,664 at
December 31, 2005 1,061 778
Common stock issuable, 330,000 at December 31, 2006 and
6,628,800 At December 31, 2005 3 59
Preferred stock, U.S. $.01 par value;
5,000,000 shares authorized; none issued or outstanding -- --
Additional paid-in capital 7,381 6,227
Deficit accumulated during the development stage (15,672) (14,087)
Accumulated other comprehensive income 747 743
-------- --------
(6,480) (6,280)
-------- --------
E 360 E 166
======== ========
The accompanying notes are an integral part of these financial statements.
50
MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31, 2006, 2005 and 2004,
and the Period from May 2, 1990 (Inception) to December 31, 2006
(In Thousands of Euros, Except Per Share Data)
Accumulated
During
Development
Stage
(May 2,
1990 to
December 31,
2006 2005 2004 2006)
------- ------- ------- ------------
Revenues
Sales E -- E -- E -- E 224
Interest -- -- -- 34
------- ------- ------- --------
-- -- -- 258
Expenses
Research and development 543 489 612 5,629
General and administrative 723 1,138 1,264 7,123
Bank fee -- -- 66 935
Interest 267 222 201 1,231
Goodwill impairment -- -- -- 209
Amortization 52 80 59 513
Directors' fees -- -- -- 274
Other -- 10 -- 10
------- ------- ------- --------
1,585 1,939 2,202 15,924
------- ------- ------- --------
Loss before income tax provision (1,585) (1,939) (2,202) (15,666)
Income tax provision -- -- -- (6)
------- ------- ------- --------
Net loss (1,585) (1,939) (2,202) (15,672)
Other comprehensive income
Foreign currency translation
adjustment 4 (98) 191 747
------- ------- ------- --------
Comprehensive loss E(1,581) E(2,037) E(2,011) E(14,925)
======= ======= ======= ========
Basic and diluted loss per share E (0.02) E (0.03) E (0.04)
======= ======= =======
The accompanying notes are an integral part of these financial statements.
51
MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIT)
For the Period from May 2, 1990 (Inception) to December 31, 2006
(In Thousands of Euros)
Accumulated
Other
Comprehensive
Deficit Income
Accumulated - Foreign
Additional During the Currency
Date of Number of Par Paid-in Development Translation
Transaction Shares Value Capital Stage Adjustment Total
------------- ---------- ----- ---------- ----------- ------------- -------
Balance at May 2, 1990
Shares issued for cash June 1990 33,311,361 E 119 E -- E -- E -- E 119
Net losses to December 31, 1999 -- -- -- (376) -- (376)
Balance at December 31, 1999 33,311,361 119 -- (376) -- (257)
---------- ----- ------ ------- ---- -------
Bank fee -- -- 806 -- -- 806
Net loss for the year -- -- -- (1,314) -- (1,314)
---------- ----- ------ ------- ---- -------
Balance at December 31, 2000 33,311,361 119 806 (1,690) -- (765)
Effect on capital structure resulting
from a business combination March 2001 8,165,830 354 (354) -- -- --
Issuance of stock purchase warrants in
connection with credit facility
(restated) March 2001 -- -- 210 -- -- 210
Issuance of shares for bank fee March 2001 1,800,000 21 (21) -- -- --
Issuance of shares for bank fee June 2001 225,144 3 (3) -- -- --
Issuance of shares for cash June 2001 1,333,333 15 2,109 -- -- 2,124
Exercise of stock purchase warrants in
repayment of debt June 2001 1,176,294 13 259 -- -- 272
Exercise of stock purchase warrants for
cash December 2001 3,250,000 37 563 -- -- 600
Net loss for the year (restated) -- -- -- (1,848) -- (1,848)
Translation adjustment -- -- -- -- 100 100
---------- ----- ------ ------- ---- -------
Balance at December 31, 2001 49,261,962 562 3,569 (3,538) 100 693
Exercise of stock options March 2002 10,000 -- 8 -- -- 8
52
Issuance of stock purchase warrants for
bank fee June 2002 -- -- 63 -- -- 63
Exercise of stock purchase warrants in
repayment of debt July 2002 1,625,567 16 396 -- -- 412
Issuance of remaining shares from 2001
business combination August 2002 46,976 1 (1) -- -- --
Net loss for the year -- -- -- (3,622) -- (3,622)
Translation adjustment -- -- -- -- 97 97
----------- ----- ------ -------- ---- ------
Balance at December 31, 2002 50,944,505 579 4,035 (7,160) 197 (2,349)
=========== ===== ====== ======== ==== ======
Issuance of shares for services September 2003 400,000 4 29 -- -- 33
Shares retired October 2003 (51) -- -- -- -- --
Issuance of shares for services November 2003 1,500,000 12 100 -- -- 112
Issuance of shares for cash December 2003 1,500,000 12 113 -- -- 125
Issuance of stock purchase warrants for
financing fee December 2003 -- -- 12 -- -- 12
Net loss for the year -- -- -- (2,786) -- (2,786)
Translation adjustment -- -- -- -- 453 453
----------- ----- ------ -------- ---- ------
Balance at December 31, 2003 54,344,454 607 4,289 (9,946) 650 (4,400)
=========== ===== ====== ======== ==== ======
Issuance of shares for services January 2004 550,000 5 27 -- -- 32
Issuance of shares for cash January 2004 2,000,000 17 150 -- -- 167
Issuance of stock purchase warrants for
financing fee January 2004 -- -- 40 -- -- 40
Issuance of shares for cash February 2004 2,500,000 21 187 -- -- 208
Issuance of stock purchase warrants for
financing fee February 2004 -- -- 62 -- -- 62
Issuance of shares for services April 2004 120,000 1 11 -- -- 12
Issuance of shares for bank fee May 2004 500,000 4 62 -- -- 66
Issuance of shares for cash May 2004 2,000,000 16 148 -- -- 164
Issuance of shares for services August 2004 250,000 2 26 -- -- 28
Issuance of shares for cash August 2004 1,466,667 12 128 -- -- 140
Issuance of stock purchase warrants for
financing fee August 2004 -- -- 46 -- -- 46
Issuance of shares for services September 2004 520,000 4 29 -- -- 33
Issuance of shares for cash September 2004 50,000 -- 4 -- -- 4
Issuance of shares for services October 2004 2,106,743 16 132 -- -- 148
Issuance of shares for services November 2004 2,000,000 15 177 -- -- 192
Issuance of shares for cash November 2004 40,000 -- 4 -- -- 4
Net loss for the year -- -- -- (2,202) -- (2,202)
Translation adjustment -- -- -- -- 191 191
----------- ----- ------ -------- ---- ------
53
Balance at December 31, 2004 68,447,864 E 720 E5,522 E(12,148) E841 E(5,065)
=========== ===== ====== ======== ==== ======
Issuance of shares for services January 2005 500,000 4 83 -- -- 87
Issuance of shares for services March 2005 200,000 2 33 -- -- 35
Issuance of shares for services March 2005 1,500,000 11 247 -- -- 258
Issuance of shares for services April 2005 60,000 1 10 -- -- 11
Issuance of shares for cash May 2005 52,000 -- 5 -- -- 5
Issuance of shares for cash June 2005 50,000 -- 3 -- -- 3
Issuance of shares for cash June 2005 50,000 -- 3 -- -- 3
Issuance of shares for cash June 2005 343,500 3 14 -- -- 17
Issuance of shares for cash June 2005 83,300 1 3 -- -- 4
Issuance of shares for cash June 2005 100,000 1 4 -- -- 5
Issuance of shares for cash July 2005 144,516 1 6 -- -- 7
Issuance of shares for cash July 2005 144,516 1 6 -- -- 7
Issuance of shares for cash July 2005 144,516 1 6 -- -- 7
Issuance of shares for cash August 2005 206,452 2 8 -- -- 10
Issuance of shares for cash August 2005 50,000 -- 2 -- -- 2
Issuance of shares for services September 2005 500,000 4 8 -- -- 12
Issuance of shares for services September 2005 500,000 4 8 -- -- 12
Issuance of shares for services September 2005 500,000 4 8 -- -- 12
Issuance of shares for services September 2005 300,000 3 5 -- -- 8
Issuance of shares for services September 2005 68,000 1 1 -- -- 2
Issuance of shares for services September 2005 173,200 1 3 -- -- 4
Issuance of shares for cash October 2005 87,459 1 2 -- -- 3
Issuance of shares for services October 2005 185,000 2 6 -- -- 8
Issuance of shares for cash October 2005 174,918 1 5 -- -- 6
Issuance of shares for cash October 2005 116,612 1 3 -- -- 4
Issuance of shares for cash November 2005 116,611 1 3 -- -- 4
Issuance of shares for cash November 2005 390,667 3 3 -- -- 6
Issuance of shares for services November 2005 20,000 -- -- -- -- --
Issuance of shares for services November 2005 20,000 -- -- -- -- --
Issuance of shares for services November 2005 20,000 -- -- -- -- --
Issuance of shares for services November 2005 500,000 5 9 -- -- 14
Issuance of shares for services December 2005 140,000 2 2 -- -- 4
Issuance of shares for cash December 2005 390,667 3 3 -- -- 6
Issuance of shares for cash December 2005 390,666 3 3 -- -- 6
Issuance of shares for cash December 2005 6,000,000 50 200 -- -- 250
Net loss for the year -- -- -- (1,939) -- (1,939)
Translation adjustment -- -- -- -- (98) (98)
----------- ----- ------ -------- ---- ------
54
Balance at December 31, 2005 82,670,464 837 6,227 (14,087) 743 (6,280)
=========== ===== ====== ======== ==== ======
Issuance of shares for services January 2006 2,500,000 21 31 -- -- 52
Issuance of shares for cash January 2006 4,000,000 33 132 -- -- 165
Issuance of shares for services January 2006 100,000 1 2 -- -- 3
Issuance of shares for cash March 2006 1,500,000 12 38 -- -- 50
Issuance of shares for cash March 2006 2,500,000 21 62 -- -- 83
Issuance of shares for cash March 2006 250,000 2 6 -- -- 8
Issuance of shares for cash March 2006 1,500,000 12 38 -- -- 50
Issuance of shares for services April 2006 100,000 1 4 -- -- 5
Issuance of shares for cash May 2006 300,000 2 3 -- -- 5
Issuance of shares for cash May 2006 300,000 3 7 -- -- 10
Issuance of shares for cash May 2006 2,350,000 18 82 -- -- 100
Debt Conversion - non cash May 2006 1,000,000 8 31 -- -- 39
Issuance of shares for cash June 2006 2,600,000 20 80 -- -- 100
Debt Conversion - non cash July 2006 1,000,000 8 72 -- -- 80
Debt Conversion - non cash July 2006 1,000,000 8 72 -- -- 80
Debt Conversion - non cash July 2006 1,000,000 8 72 -- -- 80
Debt Conversion - non cash July 2006 500,000 4 36 -- -- 40
Issuance of shares for services November 2006 300,000 2 4 -- -- 6
Issuance of shares for cash November 2006 1,300,000 10 90 -- -- 100
Issuance of shares for cash November 2006 1,280,000 10 90 -- -- 100
Issuance of shares for cash December 2006 1,320,000 10 90 -- -- 100
Issuance of shares for cash December 2006 1,320,000 10 90 -- -- 100
Issuance of shares for cash December 2006 330,000 3 22 -- -- 25
Net loss for the year -- -- -- (1,585) -- (1,585)
Translation adjustment -- -- -- -- 4 4
----------- ----- ------ -------- ---- ------
Balance at December 31, 2006 111,020,464 1,064 7,381 (15,672) 747 (6,480)
=========== ===== ====== ======== ==== ======
The accompanying notes are an integral part of these financial statements.
55
MYMETICS CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2006, 2005 and 2004
and the Period from May 2, 1990 (Inception) to December 31, 2006
(In Thousands of Euros)
Total
Accumulated
During
Development
Stage
(May 2, 1990 to
December 31,
2006 2005 2004 2006)
------- ------- ------- ---------------
Cash Flows from Operating Activities
Net loss E(1,585) E(1,939) E(2,202) E(15,672)
Adjustments to reconcile net loss to net cash
used in operating activities
Amortization 52 80 59 513
Goodwill impairment -- -- -- 209
Fees paid in warrants -- -- 148 223
Services and fees paid in common stock 66 466 511 1,994
Amortization of debt discount -- -- -- 210
Changes in operating assets and liabilities,
net of effects from reverse purchase
Receivables 27 68 (10) 23
Accounts payable 118 604 259 1,915
Taxes and social costs payable (10) (25) (13) 5
Other (27) 185 7 320
------- ------- ------- --------
Net cash used in operating activities (1,359) (561) (1,241) (10,260)
Cash Flows from Investing Activities
Patents and other (300) (52) (3) (693)
Cash acquired in reverse purchase -- -- -- 13
------- ------- ------- --------
Net cash used in investing activities (300) (52) (3) (680)
Cash Flows from Financing Activities
Proceeds from the issuance of
common stock and warrants 996 356 687 5,015
Borrowings from shareholders -- -- -- 242
Increase in note payable and other
short-term advances 618 425 241 5,095
Loan fees -- -- -- (130)
------- ------- ------- --------
Net cash provided by financing activities 1,614 781 928 10,222
Effect of exchange rate changes on cash 4 (98) 191 747
------- ------- ------- --------
Net increase (decrease) in cash (41) 70 (125) 29
Cash, beginning of period 70 -- 125 --
------- ------- ------- --------
Cash, end of period E 29 E 70 E -- E 29
======= ======= ======= ========
The accompanying notes are an integral part of these financial statements.
56
MYMETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. The Company and Summary of Significant Accounting Policies
Basis of Presentation
The amounts in the notes are rounded to the nearest thousand except for per
share amounts.
Mymetics Corporation (the "Company") was created for the purpose of engaging in
research and development of human health products. Its main research efforts
have been concentrated in the prevention and treatment of the AIDS virus. The
Company has established a network which enables it to work with education
centers, research centers, pharmaceutical laboratories and biotechnology
companies.
These financial statements have been prepared treating the Company as a
development stage company. As of December 31, 2006, the Company had not
performed any clinical testing and a commercially viable product is not expected
for several more years. As such, the Company has not generated significant
revenues. Revenues reported by the Company consist of incidental serum
by-products of the Company's research and development activities and interest
income. For the purpose of these financial statements, the development stage
started May 2, 1990.
These financial statements have also been prepared assuming the Company will
continue as a going concern. The Company has experienced significant losses
since inception resulting in a deficit in shareholders' equity (deficit) of
E6,480 at December 31, 2006. Deficits in operating cash flows since inception
have been financed through debt and equity funding sources. In order to remain a
going concern and continue the Company's research and development activities,
management intends to seek additional funding. Further, the Company's current
liabilities exceed its current assets by E6,538 as of December 31, 2006, and
there is no assurance that cash will become available to pay current liabilities
in the near term. Management is seeking additional financing but there can be no
assurance that management will be successful in any of those efforts.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and
its subsidiaries. Significant intercompany accounts and transactions have been
eliminated.
Foreign Currency Translation
The Company translates non-Euro assets and liabilities of its subsidiaries at
the rate of exchange at the balance sheet date. Revenues and expenses are
translated at the average rate of exchange throughout the year. Unrealized gains
or losses from these translations are reported as a separate component of
comprehensive income. Transaction gains or losses are included in general and
administrative expenses in the consolidated statements of operations. The
translation adjustments do not recognize the effect of income tax because the
Company expects to reinvest the amounts indefinitely in operations. The
Company's reporting currency is the Euro because substantially all of the
Company's activities are conducted in Europe.
Cash
Cash deposits are occasionally in excess of insured amounts. Interest paid was
E267 in 2006, E222 in 2005 and E201 in 2004. The Company has paid no income tax
since its inception.
Revenue Recognition
Revenue related to the sale of products is recognized when all of the following
conditions are met: persuasive evidence of an arrangement exists, delivery has
occurred, the price is fixed or determinable, and collectibility is reasonably
assured.
57
Receivables
Receivables are stated at their outstanding principal balances. Management
reviews the collectibility of receivables on a periodic basis and determines the
appropriate amount of any allowance. Based on this review procedure, management
has determined that the allowances at December 31, 2006 and 2005 are sufficient.
The Company charges off receivables to the allowance when management determines
that a receivable is not collectible. The Company may retain a security interest
in the products sold.
Goodwill and Other Intangibles
As required, the Company adopted Statement of Financial Standards ("SFAS") No.
142, "Goodwill and Other Intangible Assets," beginning January 1, 2002. Under
this standard, goodwill of a reporting unit and intangible assets that have
indefinite useful lives are not amortized but are tested annually for
impairment. Intangible assets with a finite life are amortized over their
estimated useful lives.
Current liabilities
The Company was not able to meet the E900,000 loan repayment due at September
30, 2006 to MFC Merchant Bank SA ("MFC") under its E3.7 million credit facility.
MFC had initially agreed to delay declaring a default to allow MFC and the
Company to negotiate terms of repayment acceptable to MFC, and for the Company
to identify additional investors to fund the repayment.
On September 1, 2006, the Company received a letter from MFC declaring the
Company in default. Under the terms of the credit facility, the Company's
default accelerated the repayment of the credit facility. In its letter, MFC
demanded repayment no later than September 5, 2006 of the outstanding balance
under the credit facility, totaling approximately E3.9 million including
interest through such date. The Company has not made that repayment.
In connection with the declaration of default referred to above, the Company
proceeded with lawsuits against MFC and certain prior and present officers of
MFC, KHD Humboldt Wedag International, Ltd. (f/k/a MFC Bancorp., Ltd.) alleging
breaches of fiduciary duty, interference with prospective business relations and
civil conspiracy. On March 19, 2007, we entered into a settlement under which
the E4,021 loan was terminated. See note 8.
Research and Development
Research and development costs are expensed as incurred.
Taxes on Income
The Company accounts for income taxes under an asset and liability approach that
requires the recognition of deferred tax assets and liabilities for expected
future tax consequences of events that have been recognized in the Company's
financial statements or tax returns. In estimating future tax consequences, the
Company generally considers all expected future events other than enactments of
changes in the tax laws or rates.
Earnings per Share
Basic earnings per share is computed by dividing income available to common
shareholders by the weighted average number of common shares outstanding in the
period. The weighted average number of shares was 99,716,382 for the year ended
December 31, 2006, 71,972,491 for the year ended December 31, 2005, and
62,177,629 for the year ended December 31, 2004. Diluted earnings per share
takes into consideration common shares outstanding (computed under basic
earnings per share) and potentially dilutive securities. Options were not
included in the computation of diluted earnings per share because their effect
would be anti-dilutive due to net losses incurred.
Preferred Stock
58
The Company has authorized 5,000,000 shares of preferred stock. No shares are
issued or outstanding at December 31, 2006. The preferred stock is issuable in
several series with varying dividend, conversion and voting rights. The specific
series and rights will be determined upon any issuance of preferred stock.
Stock-Based Compensation
On January 1, 2006, the Company adopted the fair value recognition provisions of
FAS No. 123(R), Share-Based Payment, ("FAS 123R"). Prior to January 1, 2006, the
Company accounted for stock-based payments under the recognition and measurement
provisions of APB Opinion No. 25, Accounting for Stock Issued to Employees ("APB
25"), and related Interpretations, as permitted by FAS No. 123, Accounting for
Stock-Based Compensation ("FAS 123"). In accordance with APB 25, no compensation
cost was required to be recognized for options granted that had an exercise
price equal to the market value of the underlying common stock on the date of
grant.
The Company adopted FAS 123R using the modified-prospective transition method.
Under that transition method, compensation cost recognized for the year ended
December 31, 2006 and thereafter will include: (a) compensation cost for all
share-based payments granted prior to, but not yet vested as of January 1, 2006,
based on the grant-date fair value estimated in accordance with the original
provisions of FAS 123, and (b) compensation cost for all share-based payments
granted subsequent to January 1, 2006, based on the grant-date fair value
estimated in accordance with the provisions of FAS 123R. The financial results
for the prior periods have not been restated. The Company will amortize stock
compensation cost ratably over the requisite service period.
If the fair value method had been applied since inception, additional
compensation costs of E320 would have been recorded. The expense for stock
options and warrants to purchase stock granted is measured using a fair value
valuation model at the date of grant multiplied by the number of options
granted.
The fair value of each option granted was estimated for proforma purposes on the
grant date using the Black-Scholes model (use of this model for proforma
purposes is not intended to indicate the value of the Company as a whole). There
were no options issued in 2006 and 2005.
The issuance of common shares for services is recorded at the quoted price of
the shares on the date the services are rendered.
Estimates
The preparation of financial statements in conformity with United States
generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
New Accounting Standards
In June 2006, the Financial Accounting Standards Board ("FASB") issued FASB
Interpretation No. 48, Accounting for Uncertainties in Income Taxes, ("FIN 48").
FIN 48 clarifies the accounting for uncertainty in income taxes and prescribes a
recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a
tax return. FIN 48 is effective for financial statements as of January 1, 2007.
The Company does not expect any material impact from applying FIN 48.
In September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, Fair Value Measurements ("FAS 157"). FAS 157 defines fair value,
establishes a framework for measuring fair value and expands disclosures about
fair value measurements but does not require any new fair value measurements.
FAS 157 is effective for financial statements issued for fiscal years beginning
after November 15, 2007, and interim periods within those fiscal years. The
Company does not expect any material impact from applying FAS 157.
59
In September 2006, the FASB issued Statement of Financial Accounting Standards
No. 158, Employers' Accounting for Defined Benefit Pension and Other
Postretirement Plans, ("FAS 158"). FAS 158 requires an employer to recognize the
overfunded or underfunded status of a defined benefit postretirement plan (other
than a multiemployer plan) as an asset or liability in its statement of
financial position and to recognize changes in that funded status in the year in
which the changes occur through comprehensive income. FAS 158 is effective for
employers with publicly traded equity securities for fiscal years ending after
December 15, 2006. Employers without publicly traded equity securities are
required to include certain disclosures until fully adopting FAS 158 for fiscal
years ending after December 15, 2006 but before June 16, 2007. The Company does
not expect any material impact from applying FAS 158.
In September 2006, the Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin No. 108 (SAB 108). Due to diversity in practice among
registrants, SAB 108 expresses SEC staff views regarding the process by which
misstatements in financial statements are evaluated for purposes of determining
whether financial statement restatement is necessary. SAB 108 is effective for
fiscal years ending after November 15, 2006, and early application is
encouraged. The Company does not expect any material impact from applying SAB
108.
In February 2007, the FASB issued Statement of Financial Accounting Standards
No. 159, The Fair Value Option for Financial Assets and Financial Liabilities,
("FAS 159"). FAS 159 permits entities to choose to measure many financial
instruments and certain other items at fair value. The objective is to improve
financial reporting by providing entities with the opportunity to mitigate
volatility in reported earnings caused by measuring related assets and
liabilities differently without having to apply complex hedge accounting
provisions. FAS 159 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. The Company does not expect any
material impact from applying FAS 159.
Note 2. Receivables
2006 2005
---- ----
Trade receivables E-- E--
Value added tax refund 15 42
--- ---
15 42
Allowance for doubtful accounts -- --
--- ---
E15 E42
=== ===
Note 3. Other Intangible Assets
Other intangible assets consist of patents which are stated at cost of the fees
paid to the French and US patent offices. At December 31, 2006 and 2005, the
carrying amount of patents and licenses was E300 and E52 net of accumulated
amortization of E380 and E328, respectively. Amortization expense relating to
patents was E52, E80, and E59 for 2006, 2005 and 2004, respectively.
Amortization expense is expected to amount to E15 each year from 2007 to 2011,
which refers only to our new license acquisition costs, amortized over 20 years,
unless new patents are filed during that year.
Note 4. Transactions With Affiliates
During 2000, the Company agreed to pay a fee in common stock to MFC Merchant
Bank SA ("MFC Bank") for services provided in a business combination
transaction. The parent of MFC Bank is a shareholder of the Company. The common
shares were not issued in 2000. The fair value of the shares at the measurement
date, amounting to E806 (which may not be indicative of the value of the Company
as a whole), was included in additional paid-in capital at December 31, 2000. In
2001, a total of 2,025,144
60
common shares were issued to MFC Bank which resulted in E24 being reclassified
to common stock based on the par value of the shares.
The Company has a non-revolving term credit facility with MFC Bank which allowed
the Company to borrow up to E3,700 at LIBOR plus 4% (approximately 7.63% at
December 31, 2006), with an instalment of E900 repayable on June 30, 2006 and
the balance due December 31, 2006, collateralized by all of the Company's assets
plus any future patents. The Company owed E4,372 and E3,754 under this facility
as of December 31, 2006 and 2005, respectively. The fair value of this note
approximates carrying value because the note is short-term and has a market rate
of interest.
The agreement allows MFC Bank to convert the loan balance into common stock at
U.S.$0.30 per share. Accordingly, 14,765,733 shares have been reserved at
December 31, 2006, for potential issuance. The Company has disputed the validity
of the loan in its lawsuit against MFC and certain of its officers and
directors. See "Credit Facility with MFC Merchant Bank S.A." under "Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters."
The Company incurred fees of E52 and E87 (paid with shares of the Company) to
MFC Bank in 2006 and 2005, respectively, related to management and financing
services.
In March 2001, the Company granted warrants under the agreements with MFC Bank
which entitled MFC Bank to purchase 6,001,693 of the Company's common shares.
The warrants allowed MFC Bank to convert to shares an amount equal to the
maximum of the credit facility including unpaid interest plus the arrangement
and retainer fees. The warrants were exercisable within a three-year period
beginning August 2000 at approximately E0.2319 per common share. Proceeds from
the credit facility were allocated pro-rata based on the relative fair values of
the credit facility and related warrants as the proceeds were received up to the
maximum proceeds available under the credit facility. The maximum limit of the
credit facility was E1,300 and the balance outstanding representing proceeds
received under the credit facility was E228. The amount attributable to the
warrants of E210 was recorded as a discount against the carrying amount of the
credit facility and a credit to additional paid-in-capital. The discount was
amortized using the effective interest method over the original term of the
credit facility, which was due August 31, 2001. During 2001, MFC Bank exercised
warrants to acquire 1,176,294 common shares in exchange for the arrangement fee
and the retainer fee plus E52 in accrued interest. MFC also exercised warrants
to acquire 3,250,000 common shares for cash in 2001. In 2002, the Company
granted 26,775 additional warrants under the original agreements with MFC Bank.
The fair value of the beneficial conversion feature on these warrants was
calculated using the Black-Scholes model which amounted to E63. This amount was
recorded as paid-in capital of E63 and allocated to bank fee expense in 2002.
During 2002, MFC Bank exercised the remaining warrants to acquire 1,602,174
common shares. This resulted in a decrease of E372 due on the revolving term
credit facility with MFC Bank. This is a non-cash transaction for purposes of
the statement of cash flows.
In June 2001, the Company issued additional warrants to MFC Bank to purchase
103,559 common shares at U.S. $1.725 per share exercisable during a three-year
period. These warrants were issued in connection with MFC Bank's placement of
1,333,333 of the Company's common shares. The warrants were valued at E118 based
on the fair value of the placement fees rendered and was a cost of the
placement. In 2002, MFC Bank exercised warrants to acquire 23,393 common shares.
This resulted in a decrease of E40 due on the revolving term credit facility
with MFC Bank. This is a non-cash transaction for purposes of the statement of
cash flows.
In July 2003, the Company sold a nonoperating subsidiary to an affiliate of MFC
Bank for cash of E25, resulting in no gain or loss.
In May 2004, the Company issued 500,000 shares of common stock to MFC Bank as
consideration for the bank's extension of the due date of the note payable to
the bank. The Company recorded a bank fee for E66 as a result of this issuance.
In March 2005, the Company issued 500,000 shares of common stock to MFC Bank as
consideration for the bank's extension of the due date of the note payable to
the bank. The Company recorded a bank fee for E88 as a result of this issuance.
61
In January 2006, the Company issued 2,500,000 shares of common stock to MFC Bank
as consideration for the bank's extension of the due date of the note payable to
the bank. The Company recorded a bank fee for E52 as a result of this issuance.
In March 2007, the Company entered into a settlement agreement related to this
credit facility. See note 8.
The amounts payable to shareholders bear no interest, have no collateral, and
are repayable upon the Company becoming profitable. Since the timing of the
Company becoming profitable cannot be determined, the fair value of the amounts
payable to shareholders cannot be determined. The Company is not expected to
become profitable in the near-term, therefore, the amounts payable to
shareholders have been classified as long-term.
The Company owes officers approximately E338 at December 31, 2006, for salaries
and fees and also for expenses paid on behalf of the Company. These amounts are
unsecured, do not bear interest and are included in accounts payable.
In July 2006, the officers agreed to convert approximately half of their current
claims or E280 into 3,500,000 shares of common stock of Mymetics Corporation at
a price per share of $0.10. The current market price was then $0.05 or less.
62
Note 5. Income Taxes
The reconciliation of income tax on income computed at the federal statutory
rates to income tax expense is as follows:
2006 2005 2004
----- ----- -----
U.S. Federal statutory rates on loss from
operations E(539) E(659) E(749)
Nondeductible fee paid in warrants and common
stock -- -- 224
Effect of exchange rate changes on
U.S. net operating loss carryforward 257 (235) 103
Increase in valuation allowance 282 894 423
Other -- -- (1)
----- ----- -----
Income tax provision E -- E -- E --
===== ===== =====
Deferred tax asset is composed of the following:
2006 2005
------- -------
Difference in book and tax basis of amounts payable to shareholder E 82 E 82
Net operating loss carryforwards
United States 2,489 2,224
France 1,238 1,253
------- -------
3,809 3,559
Less valuation allowance for deferred tax asset (3,809) (3,559)
------- -------
Net deferred tax asset E -- E --
======= =======
The change in the valuation allowance was E282 less E32 related to expiring
French net operating losses.
63
The Company's provision for income taxes was derived from U.S. and French
operations. At December 31, 2006, the Company had estimated net operating loss
carryforwards which expire as follows:
United
States France
------ ------
2006 E -- E 381
2007 -- 1,039
2008 -- 801
2009 -- 1,290
2010 -- 80
2011-2026 7,320 50
------ ------
E7,320 E3,641 (*)
====== ======
(*) French losses would be lost should the company be liquidated in 2007
following its emergence from receivership. The change in the valuation
allowance was E282 less E32 related to expiring French net operating
losses.
Note 6. Stock Option Plans
1994 Amended Stock Option Plan
The Company's 1994 stock option plan provided for the issuance of up to 350,000
shares of the Company's common stock to employees and non-employee directors.
The plan was terminated during 2002. The following table summarizes information
with respect to this plan:
Weighted
Number Average
of Exercise
Shares Price
------- ----------
Outstanding and exercisable
at December 31, 2004 13,750 U.S. $1.11
Expired in 2005 (1,250) .75
Outstanding and exercisable
at December 31, 2005 12,500 U.S. $1.15
Expired in 2006 (12,500) 1.15
-------
Outstanding and exercisable
at December 31, 2006 --
=======
Reserved for future grants at
December 31, 2006 --
=======
1995 Qualified Incentive Stock Option Plan
The Company's board of directors approved a stock option plan on August 15,
1996, which provided for the issuance of up to 150,000 shares of the Company's
common stock to key employees. The plan was terminated during 2002. The
following table summarizes information with respect to this plan:
64
Weighted
Number Average
of Exercise
Shares Price
-------- ----------
Outstanding and exercisable
at December 31, 2004 100,000 U.S. $.75
Expired in 2005 (100,000) .75
Outstanding and exercisable
At December 31, 2005 and 2006 -- --
======== =========
Reserved for future grants
at December 31, 2006 --
========
The exercise price on these options is $0.75.
2001 Qualified Incentive Stock Option Plan
The Company's board of directors approved a stock option plan on June 15, 2001,
which provides for the issuance of up to 5,000,000 shares of the Company's
common stock to employees and non-employee directors. No options were issued in
2005 and 2006. The weighted average fair value of these options at the grant
dates were E0.12 and E0.62 per option in 2003 and 2002, respectively. The
following table summarizes information with respect to this plan:
Weighted
Number Average
of Exercise
Shares Price
--------- ---------
Outstanding and exercisable
at December 31, 2004, 2005
and 2006 442,500 U.S. $ .97
========= ==========
Reserved for future grants
at December 31, 2006 4,557,500
=========
Almost all options have an expiration date ten and a half years after issuance.
At December 31, 2006, exercise prices range from $0.12 to $3.50. There was no
intrinsic value on outstanding options at December 31, 2006.
Note 7. Commitments and Contingencies
Total rent expense per year was E15 for 2006, E15 for 2005, and E32 for 2004.
All leases can be cancelled at short notice with no penalties.
On October 26, 2006, the Court of Appeals of Lyon (France) overturned a
judgement rendered by the Lyon Industrial Tribunal ("Prud'hommes") in favor of
Dr. Pierre-Francois Serres, a former director and officer of the Company. Under
this lower court judgement and as disclosed on Form 10-K for the year ended
December 31, 2005 to the Securities and Exchange Commission, Dr. Serres was
awarded approximately E173,000. In the court's decision, the Company will not
have to pay this amount and will receive reimbursement of approximately E33,000
he had previously been able to seize from the company's bank account based on
the lower court's initial judgement. We intend to vigorously pursue this matter
until fully resolved.
Note 8.
Subsequent Events
65
In January 2007, the Company issued 650,000 common shares to an investor for
$65,500 and 1,000,000 common shares to four individuals as fee for services
rendered. In February 2007, 1,745,000 shares were issued to three investors for
$174,500.
In January 2007, the Company issued 8,712,000 common shares to an investor for
E990,000. The same investor also granted an unsecured loan in the amount of
E500,000 at 5% interest, repayable on March 19, 2008, in view of financing the
settlement discussed below.
In March 2007, the Company entered into a settlement agreement to settle
outstanding amounts due under the credit facility granted by MFC Merchant Bank
SA (see note 4). In connection with the settlement, the Company paid E1.49
million and issued 12,500,000 common restricted shares. The payment of cash was
applied to the outstanding credit facility balance with the remainder considered
as a conversion of debt into equity on the issuance of the Company's shares. No
gain or loss resulted from this transaction.
66
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
Mymetics Corporation
By: /s/ Christian Rochet
------------------------------------
Name: Christian J.F. Rochet
Title: Chief Executive Officer
----------------------------------------
(Date)
67
POWERS OF ATTORNEY
Each person whose signature appears below constitutes and appoints Ernst
Luebke as his true and lawful attorneys-in-fact and agents, with full power of
substitution and resubstitution, for him and in his name, place and stead, in
any and all capacities, to sign any or all amendments to this Annual Report on
From 10-K, and to file the same, with all exhibits thereto and other documents
in connection therewith, with the U.S. Securities and Exchange Commission,
granting unto said attorneys-in-fact and agents full power and authority to do
and perform each and every act and thing requisite and necessary to be done, as
fully to all intents and purposes as he might or could do in person, hereby
ratifying and confirming all that said attorneys-in-fact and agents or their
substitute or substitutes may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature Title
--------- -----
/s/ Christian J.F. Rochet Chief Executive Officer and Director
------------------------------------- (Principal Executive Officer)
Christian J.F. Rochet
-------------------------------------
(date)
/s/ Ernst Luebke Chief Financial Officer and Director
------------------------------------- (Principal Financial and Accounting
Ernst Luebke Officer)
-------------------------------------
(date)
/s/ Sylvain Fleury Chief Scientific Officer and
------------------------------------- Director
Sylvain Fleury, Ph. D.
-------------------------------------
(date)
68