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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
FOR ANNUAL AND TRANSITION REPORTS
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period
from to |
Commission File No. 0-19591
Epimmune Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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33-0245076 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
5820 Nancy Ridge Drive,
San Diego, California 92121
(Address of Principal executive offices) |
Registrants telephone number, including area code:
(858) 860-2500
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $.01 par value
(Title of class)
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by 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 þ No o
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 Registrants
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. þ
Indicate by check mark whether the Registrant is an accelerated
filer as defined in Rule 12b-2 of the Securities Exchange
Act of
1934. Yes o No þ
The aggregate market value of the Registrants Common Stock
held by non-affiliates of the Registrant as of June 30,
2004 was approximately $26.7 million, based on the closing
price on that date of Common Stock on the Nasdaq National Stock
Market.*
The number of shares outstanding of the Registrants Common
Stock, $.01 par value, was 16,023,786 as of March 29,
2005.
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Excludes 293,693 shares of Common Stock held by directors
and officers and stockholders whose ownership exceeds 10% of the
Common Stock outstanding on June 30, 2004. Exclusion of
shares held by any person should not be construed to indicate
that such person possesses the power, direct or indirect, to
direct or cause the direction of the management or policies of
the Registrant, or that such person is controlled by or under
common control with the Registrant. |
PART I
Forward Looking Statements
Except for the historical information contained herein, the
following discussion contains forward-looking statements that
involve risks and uncertainties. These statements reflect
managements current views with respect to future events
and financial performance and actual results could differ
materially from those discussed here. Factors that could cause
or contribute to such differences include, without limitation,
those discussed in the description of our business below and the
sections entitled Risk Factors and
Managements Discussion and Analysis of Financial
Condition and Results of Operations, and in our other SEC
filings. We expressly disclaim any intent or obligation to
update these forward-looking statements, except as required by
law.
Epimmune® and PADRE® are our trademarks and EIS and
ImmunoSense are our service marks.
Overview
We are developing therapeutic vaccines that use multiple
epitopes, or protein fragments, to specifically activate the
bodys immune system for the more effective management of
infectious diseases and cancer.
On March 16, 2005, we announced that we had agreed to
combine our business with IDM S.A. (Immuno-Designed Molecules),
or IDM, a privately held company based in France, pursuant to a
Share Exchange Agreement. The all-stock transaction has been
unanimously approved by the boards of directors of both
companies. In addition, certain institutional investors,
strategic partners and executives of IDM, who collectively hold
more than 85% of IDMs outstanding stock (including shares
issuable upon exercise of warrants), have entered into the Share
Exchange Agreement thus far. The closing of the transaction is
subject to certain closing conditions including approval by our
shareholders. Upon closing of the transaction, the combined
company will be named IDM, Inc. and its shares are expected to
be traded on the Nasdaq National Market under the ticker IDMI.
The combined company will focus on immunotherapeutic products
for cancer and selected infectious diseases.
Pursuant to the Share Exchange Agreement, we will acquire all of
the outstanding share capital of IDM, with certain exceptions
related to shares and a warrant held in French share savings
plans, in exchange for shares of our common stock, and IDM will
become a subsidiary of Epimmune. Each share of IDM will be
exchanged for approximately 3.771865 shares of our common
stock, and the former shareholders of IDM will hold, in the
aggregate, approximately 78% of our outstanding common stock, on
a fully diluted basis, immediately following the closing of the
transaction. The shares we issue in the exchange will not be
registered under U.S. securities laws and may not be
offered or sold in the U.S. absent registration or unless
an applicable exemption from the registration requirements is
available. We will file a registration statement covering the
resale of the shares issued in the transaction following the
closing of the transaction.
Subsequent to the transaction, IDM will effectively control us.
As a result, the transaction will be accounted for as a reverse
acquisition, whereby for financial reporting purposes, IDM is
considered the acquiring company. Hence, the historical
financial statements of IDM will become our historical financial
statements and will include our results of operations only from
the acquisition date forward.
In September 2002, we commenced a Phase I/ II clinical
trial of our therapeutic, multi-epitope vaccine candidate EP
HIV-1090 in patients infected with HIV-1, which is the
predominant strain of HIV in North America and Western Europe.
Patients enrolled in the trial were immunized while receiving
multiple antiretroviral drugs. This clinical trial has now been
closed and the study has been unblinded. In July 2004 we
announced that the vaccine was safe and well tolerated at all
dose levels and disease specific indicators such as helper T
cell, or HTL, counts had remained stable throughout the trial.
In December 2004, we reported that an immunogenicity analysis
found that in general, vaccine specific cytotoxic T cell, or
CTL, responses were not readily detected in the presence of
pre-existing HIV-1 CTL responses. Supplemental studies utilizing
more sensitive assays indicated that low-level CTL responses
were induced in some of the subjects. Based on
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the results of this initial study, we plan to amend our
Investigational New Drug Application, or IND, to open a second
arm of the Phase I/ II clinical trial in 2005 to determine
if an alternate route of delivery in conjunction with a
compressed immunization schedule will result in an enhanced
immune response.
In February 2003, we also commenced two Phase I/ II
clinical trials of our therapeutic, multi-epitope vaccine
candidate EP-2101, one in patients with non-small cell lung
cancer, or NSCLC, and one in patients with colorectal cancer.
The primary objective of these trials was to determine the
safety and immunogenicity of the EP-2101 vaccine. Final safety
data for these trials revealed that the EP-2101 vaccine was both
safe and well tolerated. A final immunogenicity analysis of CTL
responses, in patients who completed the study, indicated that
the vaccine was immunogenic and effective at inducing strong and
broad CTL responses in at least 50% of the patients. Based on
these results, we initiated a phase II trial involving late
stage NSCLC patients in December 2004.
In July 2001, we entered into collaboration with Genencor
International, Inc. for vaccines to treat or prevent hepatitis B
virus, hepatitis C virus and human papilloma virus. In
February 2004, we announced that we had earned a milestone
payment from Genencor as a result of Genencor filing an
Investigational New Drug Application, or IND, for a vaccine to
treat hepatitis B, the lead program in the collaboration. In
March 2004, Genencor assigned its rights under our collaboration
to Innogenetics NV. In connection with the assignment by
Genencor, we extended the collaboration term with Innogenetics
through September 2005. Innogenetics will have the right to
terminate the collaboration early, upon three months written
notice.
Eliciting a strong cellular, or T cell, immune response is
crucial for treating and preventing many infectious diseases and
tumors. Clinical experience has shown that the cellular immune
response is directly related to viral clearance and tumor
regression in those patients who are able to clear chronic viral
infection without treatment and in cancer patients who respond
to immunotherapy, or treatment that stimulates an immune
response. This successful cellular immune response includes
activity of CTLs and HTLs which are directed toward specific
antigen fragments, known as epitopes.
Market Opportunities
It is estimated that approximately 940,000 people in North
America and nearly 560,000 people in Western Europe are
currently infected with HIV. According to estimates, in the
United States alone, an additional 40,000 people are newly
infected with HIV each year. The standard approach to treating
HIV infection has been to lower viral loads by using drugs that
inhibit two of the viral enzymes that are necessary for the
virus to reproduce: reverse transcriptase inhibitors, or RTIs,
protease inhibitors, or PIs, or a combination of these drugs.
Current therapies based on combinations of RTIs or PIs, reduce
HIV viral loads in many patients. In 2000, deaths attributable
to HIV infection were reduced to approximately 15,000 from
38,000 in 1996, largely due to improvements in treatment
regimens. Total sales in 2001 of approved RTIs and PIs exceeded
$3.1 billion in the United States and $5.0 billion
worldwide.
While significant progress has been made in combating HIV,
current treatments continue to have significant limitations,
such as viral resistance, toxicity and non-adherence to the
complicated treatment regimens. HIV is prone to genetic changes
that can produce strains of HIV that are resistant to currently
approved RTIs and PIs. Generally, HIV that is resistant to one
drug within a class is likely to become resistant to the entire
class, a phenomenon known as cross-resistance. As a result of
cross-resistance, attempts to re-establish suppression of HIV
viral load by substituting different RTI and PI combinations
often fail. It is estimated that, in the United States, over 70%
of patients currently taking medications have failed at least
one regimen. Studies suggest that 10% to 15% of newly-infected
HIV patients in the United States have become resistant to at
least one member of each of the classes of currently approved
anti-HIV drugs, and that number is believed to be growing.
Over time, in addition to generating resistance to drugs, many
patients develop intolerance to different medications. Data
suggest that some HIV infected patients refuse to commence or
continue taking RTIs and PIs, either alone or in combination,
because of side effects and difficult dosing regimens. Several
side effects
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commonly associated with currently approved anti-HIV drugs
include neurological disorders, gastrointestinal disorders,
diabetes-like symptoms, elevated cholesterol levels, other
abnormal lipid metabolism and bone disorders. Dosing regimens
can require taking as many as 30 pills per day. The emergence of
drug-resistant strains of HIV, as well as toxic side effects
associated with existing therapies, have heightened demand for
new HIV therapies that work by different mechanisms of action,
and have unique resistance profiles, fewer side effects and a
simpler dosing regimen.
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Lung and Colorectal Cancer |
The World Health Organization (WHO) predicts that by 2020
there will be 15 million cases of cancer every year. In the
United States approximately 1.25 million new cases of
cancer are diagnosed annually and cancer is, by 2020, expected
to surpass heart disease as the primary cause of death in
adults. Of the various cancers, the four most common types
include lung, breast, prostate and colorectal cancer. These four
cancers have the greatest incidence of new cases and are
responsible for the highest combined mortality, approximately
58.1% of all cancer deaths worldwide. In the United States
alone, there were an estimated 147,500 new cases of colorectal
cancer diagnosed in 2003 and colorectal cancer represents the
third highest incidence of any cancer for American men. In 2003,
an estimated 57,000 deaths in the United States were attributed
to colorectal cancer. Cancer of the lungs continues to be a
major health problem with a very high mortality rate and
represents the leading cause of cancer death in the United
States. Approximately 171,900 new lung cancer cases were
diagnosed in the United States in 2003, and an estimated
157,200 patients died from lung cancer. In addition nearly
75% of cancers are expected to occur in individuals over the age
of 55 and demographic trends clearly show an aging population.
The current course of treatment for lung cancer includes
surgery, if possible, followed by various regimens of radiation
and chemotherapy to try to destroy cancer cells that have
spread. Chemotherapy causes well-known adverse side effects such
as hair loss, decreased function of various organs, and a
substantial suppression of the immune system, leading to
susceptibility to other diseases. The side effects of these
treatments, combined with relatively low success rates for most
cancers, have led to the need for development of different
methods of treatment. The unmet needs for more effective cancer
treatments provide a significant market potential for emerging
therapeutics. Current pharmaceutical therapies for lung cancer
include taxanes, platinum-based drugs and nucleoside analogs,
with combined sales exceeding $2.3 billion in 2001. Drug
therapies for colorectal cancer had combined sales in excess of
$700 million in 2001. According to a PhRMA 2003
report on pharmaceutical drug development, there were 395 new
product candidates in clinical development for the treatment of
cancer and at least 30 companies were developing more than
50 vaccines against various cancers.
The Immune Response
The immune system is the bodys natural defense mechanism
to prevent and combat disease. The immune system differentiates
between normal tissue, or self, and diseased tissue, or
non-self. When a competent immune system recognizes diseased
cells, a series of steps ensues resulting in the elimination of
these cells. There are two types of immune response:
antibody-based and cellular or T cell-based.
The antibody immune response is involved primarily in the
prevention of diseases. Antibodies are proteins produced by the
body in response to disease causing agents known as pathogens.
Antibodies bind to pathogens, including viruses and bacteria,
and block their ability to infect cells. Preventative vaccines
that trigger an antibody-based immune response have been very
successful in reducing the incidence of several deadly diseases,
including polio and measles. These vaccines generally consist of
weakened or attenuated pathogens that stimulate the production
of antibodies. However, these types of vaccines have not been
effective in the prevention or treatment of many serious
diseases, including cancers and infectious diseases.
The cellular, or T cell-based, immune response is involved
primarily in combating cancers and infectious diseases. T cells
are specialized white blood cells that are normally produced by
the body to kill cancer cells and infected cells. The cellular
immune response begins when specialized immune cells, called
antigen-presenting cells, capture antigens, the structural
components that distinguish cancers and pathogens from
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normal tissues. Once inside antigen-presenting cells, these
protein antigens are broken down into small peptide fragments,
called epitopes that are subsequently displayed on the surface
of the antigen-presenting cell. T cells continually scan the
surface of antigen-presenting cells for epitopes bound to a cell
surface receptor referred to as the major histocompatibility
complex, or MHC. If T cells recognize displayed epitopes as
foreign or non-self, the T cells replicate rapidly and then
search for and kill other diseased cells displaying those same
epitopes.
Significant scientific evidence suggests that cancers and
infections trigger a T cell-based immune response during the
initial course of disease progression. For diseases such as the
ones we are targeting, this immune response alone is usually
insufficient to eradicate the disease. Studies have analyzed the
effective cellular response in individuals who clear chronic
viral infection without treatment, and in cancer patients who
respond to immunotherapy. This effective cellular response is
comprised of CTL and HTL directed toward multiple, discrete,
specific, antigen-specific epitopes. Therapeutic vaccines
attempt to recreate this successful multi-specific CTL and HTL
response.
To date, efforts to develop vaccines that stimulate
multi-specific T cell responses sufficient to selectively and
accurately target and kill diseased cells have failed. We
believe this failure is due to one or both of the following:
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the inability of drug developers to identify the antigens
appropriate to induce the desired immune response; and |
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the inability to present or display these relevant antigens in a
manner that induces T cell responses sufficiently potent and
broad enough to actually destroy diseased cells. |
Based on our animal study data thus far and the results from our
Phase I/ II clinical trials in non-small cell lung cancer
and colorectal cancer, we believe our technology and vaccine
candidates specifically address these issues.
Our Approach
Our approach to T cell vaccine development is to rationally
create a multi-specific cellular response, causing the immune
system to be stimulated specifically against multiple, select
epitopes, which meet stringent criteria. We have developed our
Epitope Identification system proprietary technology, known as
EIS, to rapidly identify these antigen-specific epitopes from
the genetic information of tumor-associated antigens or
infectious agents (such as viruses, bacteria and parasites).
Our approach of using epitopes in vaccine development offers
several distinct advantages over traditional vaccine approaches.
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Enhanced Potency: For some diseases, such as cancer,
whole antigens or even naturally occurring epitopes may not be
sufficient to generate an effective immune response. In
contrast, we are selectively altering the composition of
specific epitopes in vaccines to enhance the desired immune
response. |
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Sustained Efficacy: We select multiple epitopes from
conserved regions of multiple viral or tumor-associated
antigens, increasing the likelihood that the vaccine will
continue to elicit an effective immune response as the virus or
tumor changes. |
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Improved Safety: The use of selected, well defined
epitopes is designed to elicit a specifically targeted immune
response with fewer undesired side effects than can be caused by
whole antigen vaccines. |
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Better Quality Control: Our approach allows us to develop
well-characterized, fully synthetic vaccines with a high degree
of consistency, simplifying manufacturing and product
characterization. |
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Broader Disease and Population Coverage: We are designing
vaccines using multiple epitopes so that our vaccines can
address different strains of a disease or be used to treat the
worlds diverse population, regardless of varying genetic
profiles. |
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Our Vaccine Product Candidates
We have a number of vaccine product opportunities as described
in the following table:
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Commercialization |
Indication |
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Product Development Stage(1) |
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Rights |
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Infectious Diseases
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Therapeutic Vaccines
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HIV
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Phase I/II Clinical Trial |
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Epimmune |
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Hepatitis B
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Phase I Clinical Trial |
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Innogenetics |
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Hepatitis C
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Preclinical |
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Innogenetics |
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Papilloma virus
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Preclinical |
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Innogenetics |
Prophylactic Vaccines
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HIV
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Preclinical/Phase I Clinical Trial(2) |
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Epimmune |
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Malaria
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Preclinical |
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Epimmune |
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Hepatitis C
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Preclinical |
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Innogenetics |
Cancer
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Therapeutic Vaccines
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Colorectal
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Phase I/II Clinical Trial completed |
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Epimmune |
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Non-Small Cell Lung
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Phase II Clinical Trial ongoing |
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Epimmune |
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Breast
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Preclinical |
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Epimmune |
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Prostate
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Epitope/Antigen Identification |
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Epimmune |
Ex Vivo Immunotherapy
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Various Solid Tumors
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Preclinical |
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Anosys |
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Various Solid Tumors
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Preclinical |
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IDM |
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(1) |
By using the term Epitope/ Antigen Identification, we mean that
we are discovering, evaluating and selecting epitopes for
inclusion in candidate vaccines that would be advanced to
preclinical development. By using the term Preclinical, we mean
that we have identified and selected specific epitope
compositions for inclusion in a vaccine and are conducting
preclinical testing aimed at optimizing the construction,
formulation and manufacture of the vaccine and toxicology
studies with the objective of filing an investigational new drug
application or IND with regulatory authorities. |
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Phase I clinical trial being conducted by the National
Institutes of Health, or NIH and HIV Vaccine Trials Network, or
HVTN. |
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Therapeutic Vaccine for HIV |
We commenced our Phase I/ II clinical trial of our EP
HIV-1090 therapeutic, multi-epitope vaccine in HIV-1-infected
patients in September 2002. The EP HIV-1090 vaccine is composed
of 21 CTL epitopes, which were selected from conserved regions
of multiple HIV proteins using our EIS proprietary technology.
The use of conserved epitopes is expected to make it much less
likely that the virus will develop genetic changes or mutations
that can escape the vaccine-induced immune response. The vaccine
candidate is delivered as DNA combined with PVP, a polymer shown
to increase the potency of DNA vaccines in animal studies. In
addition, the vaccine includes our PADRE® universal helper
T cell epitope, which is designed to enhance the magnitude and
duration of CTL response. We have filed several patent
applications in the United States and abroad that disclose the
epitopes comprising the EP HIV-1090 vaccine construct, both as
individual epitopes and as our EP HIV-1090 epigene construct
itself. An epigene is a string of DNA coding for select epitopes
from several antigens. The applications are at various stages of
prosecution.
The initial Phase I/ II trial was a double blind,
placebo-controlled, dose escalation study including
40 patients. Patients enrolled in the trial were immunized
while receiving multiple antiretroviral drugs, a regimen termed
highly active antiretroviral therapy, to reduce the suppressive
effects that HIV has on the immune system. This therapeutic
trial was closed in October 2004. Based on analysis of safety
data no serious adverse events were observed and disease
specific indicators such as CD4+ T cell counts remained stable,
indicating that EP HIV-1090 was safe and well tolerated at all
dose levels. For the assessment of immunogenicity, we tested
patient blood samples using independent in vitro ELISPOT
assays which measure
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the number of epitope-specific CTL per million peripheral blood
mononuclear cells, or PBMCs, in the patient samples. This
testing was completed for all patients at baseline, or week 0,
and two weeks after the last immunization at week 18. In
general, vaccine specific CTL responses were not readily
detected in the presence of pre-existing HIV-1 CTL responses.
Using a definition that an EP HIV-1090 response is a three fold
increase in the CTL activity for at least two epitopes, two out
of 32, or 6%, of vaccine recipients exhibited a significant
epitope-specific immune response. Expanded immunogenicity
testing using in vitro peptide stimulation to detect low
level CTL response has found that 28% of vaccine recipients
responded to immunization. In this test, after blood draws, the
PBMC are incubated in vitro for seven days with a pool of
the 21 vaccine epitopes prior to detecting the epitope-specific
CTL. The incubation expands the population of epitope-specific
cells, thereby increasing assay sensitivity. It may also
stimulate the in vivo reemergence of HIV antigen that occurs
when patients withdraw from anti-retroviral drug therapy.
Based on the results of this initial study, we plan to amend our
IND in 2005 to open a second arm of the Phase I/ II
clinical study with EP HIV-1090 to determine if using a needle
free injection device in conjunction with a compressed
immunization schedule will result in an enhanced immune
response. The additional evaluation would be conducted in two
dose groups consisting of 2 and 4 mgs of vaccine or placebo
respectively, assuming the safety profile of EP-1090 remains
favorable. The study arm will involve approximately
16 patients in each dose group, 12 receiving vaccine and 4
receiving placebo. Total study duration for each patient,
including follow-up, is estimated to be approximately six months.
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Therapeutic Vaccine for Non-Small Cell Lung and Colorectal
Cancer |
We commenced our Phase I/ II clinical trial of our EP-2101
therapeutic, multi-epitope vaccine in NSCLC and colorectal
cancer patients in February 2003. The primary objectives of this
trial were to determine the safety and immunogenicity of the
EP-2101 vaccine. The Phase I/ II trial closed to enrollment
in April of 2004, with the final patient completing the study in
August 2004. A total of 24 patients were enrolled between
the two studies, resulting in 16 patients who completed the
trial. Final safety data showed that the EP-2101 vaccine was
safe and well tolerated in the 24 patients who were treated
with the vaccine. The most common side effect reported was a
localized reaction at the injection site. Final immunogenicity
data from the patients analyzed showed that the vaccine was
immunogenic and effective at inducing strong and broad CTL
responses in at least 50% of the patients.
Based on these responses, a Phase II clinical protocol was
submitted to the FDA in early September to test EP-2101 in
advanced stage NSCLC patients in a Phase II trial. The
primary endpoints for this trial will be safety and overall
survival, with progression-free survival, and immunogenicity of
vaccine epitopes being secondary endpoints. The trial, which
will utilize between 10 and 12 sites and will enroll
approximately 84 patients, opened to enrollment in December
2004 and is scheduled to complete enrollment by the end of 2005.
Initial data from the study is expected to be available
beginning in the second half of 2006.
Our initial cancer vaccine candidate is composed of multiple
tumor-specific CTL epitopes that were selected from
tumor-associated antigens using our proprietary processes. Some
of the epitopes have been modified to create analogs in order to
enhance the potency of the T cell response induced by the
vaccine. The vaccine candidate is delivered as an injection of
peptide epitopes in combination with conventional therapies. In
addition, the vaccine candidate includes our PADRE®
universal helper T cell epitope. We have filed several patent
applications in the United States and abroad that disclose the
individual peptides that comprise our initial cancer vaccine
candidate. These applications are also in various stages of
prosecution. In addition, we have filed applications directed to
the specific epitopes comprising the vaccine to be delivered in
the form of peptides and an adjuvant.
Clinical trial results and studies conducted by others
correlating T cell infiltration into tumors with a more
favorable prognosis indicate that T cells can play an important
role in the control and elimination of cancer cells. However,
because cancer cells are inefficient at inducing anti-cancer T
cell responses, tumors grow and metastasize without attracting
the attention of the immune response. Also, once tumors become
large, they suppress the immune system by liberating factors
that inhibit T cell activation. Following standard therapy to
remove the majority of the cancer cells, our vaccine will be
administered to patients in order to
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induce a strong T cell response that we believe will eliminate
any remaining cancer cells and prevent disease recurrence.
In February 2004, we announced that we had earned a milestone
payment from Genencor as a result of Genencor filing an IND for
a vaccine to treat hepatitis B, the lead program in the
collaboration. In April 2003, we announced that the NIH held an
active IND to test our EP HIV-1090 vaccine for the prevention of
HIV infection. The HVTN is conducting the Phase I trial.
In addition, through a combination of strategic collaborations
as well as funding from the NIH, we are conducting research and
preclinical development of vaccines to treat breast, prostate
and other cancers, hepatitis C and human papilloma virus
and vaccines for the prevention of hepatitis C, HIV and
malaria. We believe our technology has broad applicability and
will allow us to develop vaccines to pursue these cancer and
infectious disease indications.
Our Technology
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Epitope Identification System (EIS) |
We developed and optimized our EIS based on extensive work over
the past twelve years in the field of T cell recognition and
stimulation. Our intellectual property portfolio includes one
issued patent and several pending patent applications having
claims directed to methods of using sequence motifs to identify
and make peptide epitopes. With the genetic sequence of a
tumor-associated antigen, virus, bacteria or parasite as input,
we use EIS to rapidly identify antigen-specific epitopes that
meet pre-determined criteria for broad conservation, binding,
population coverage and immunogenicity.
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We use computer algorithms to analyze the sequence of all known
antigens associated with the target disease for the presence of
peptides that contain specified types of epitopes from conserved
regions of the antigens. |
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We synthesize peptides that meet these requirements and perform
in vitro assays to assess binding to human MHC
molecules referred to as human leukocyte antigens, or HLA. |
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We evaluate peptides to assess their ability to bind broadly to
a spectrum of MHC molecules referred to as HLA. We identify
epitopes from these peptides that enable broad population
coverage for the vaccine being developed. |
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We then test peptides for immunogenicity, both in vivo in
transgenic mice, which express HLA, and in vitro
against infected or transfected cells. |
Using EIS, we have already identified T cell epitopes for a
number of diseases, including breast, colon, lung and prostate
cancers, as well as hepatitis C virus, hepatitis B virus,
human papilloma virus, HIV and malaria.
Our candidate vaccines for each infectious disease and cancer
indication are comprised of the particular epitopes that can
stimulate the specific T cells needed to combat the relevant
indication. We select epitopes for a target indication using EIS
and then combine them to form a multi-epitope vaccine. In the
case of our initial HIV vaccine candidate, EP HIV-1090, we used
proprietary processes to combine the selected epitopes in a
specific, optimized sequence and formed an epigene. In animal
models, epigene vaccines have elicited strong multi-specific T
cell responses that are both stronger and broader than the
responses generated by whole antigen DNA vaccines.
The first of our candidate vaccines to enter human clinical
trials was our EP HIV-1090 therapeutic vaccine targeting HIV.
The vaccine incorporates multiple CTL epitopes from six HIV
associated antigens and our PADRE® universal helper T cell
epitope. We began a Phase I/ II clinical trial of our EP
HIV-1090
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therapeutic, multi-epitope vaccine in HIV-1 infected patients in
September 2002. In January 2004, we announced that we had
completed patient enrollment in the trial and that all of the
patients in the final dose group had received their initial
vaccinations. This therapeutic trial was closed in October 2004.
Based on analysis of safety data, no serious adverse events were
observed and disease specific indicators such as CD4+ T cell
counts remained stable, indicating that EP HIV-1090 was safe and
well tolerated at all dose levels. Based on the safety and
immunogenicity results of this initial study, we plan to amend
our IND in 2005 to open a second arm of the Phase I/ II
clinical study with EP HIV-1090 to determine if using a needle
free injection device in conjunction with a compressed
immunization schedule will result in an enhanced immune
response. Also, in April 2003, the NIH and HVTN began a
Phase I clinical trial of our EP HIV-1090 vaccine for the
prevention of HIV infection.
In addition to the Phase I/ II clinical trial for our HIV
vaccine, we are conducting a Phase II clinical trial of our
EP-2101 vaccine in lung cancer patients. We have also assisted
in advancing a partnered program in hepatitis B into a
Phase I clinical trial and are advancing other epigene
candidate vaccines for HIV, hepatitis C virus and human
papilloma virus in preclinical development. To be effective in
treating or preventing HIV, hepatitis B virus, hepatitis C
virus and human papilloma virus, vaccines should target multiple
strains of the virus and induce T cells directed at conserved
regions of the virus. Our candidate vaccines incorporate
epitopes, which are selected from multiple viral proteins and
from highly conserved regions of the virus.
Our PADRE® universal helper T cell epitope consists of a
family of small (13 amino acid), synthetic proprietary molecules
that are potent immunostimulants, meaning that they stimulate
the immune response. When combined with disease-specific
antigens, PADRE® induces important signals that enhance the
antigen-specific immune response, enabling the production of
more effective antibody responses. We believe that PADRE®
offers several advantages over the immunogenic carrier proteins
traditionally used to enhance antibody vaccines:
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PADRE® can be easily synthesized and its linkage to
an antigen readily characterized, whereas the carrier proteins
traditionally used to enhance immune response can complicate
manufacturing; |
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The antibody responses generated by PADRE® are primarily
specific to the vaccine antigen, rather than to PADRE®,
whereas carrier proteins generate high antibody responses
specific primarily to the carrier protein itself rather than to
the vaccine antigen, which can render the vaccine
ineffective; and |
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Because it simplifies vaccine manufacture and induces antibodies
primarily specific to the vaccine antigens with which it is
used, PADRE® could simplify the development of combination
vaccines, whereas the use of carrier proteins is generally
limited to vaccines containing single protein antigens. |
We use our PADRE® technology in all of our T cell vaccines
and have licensed this technology to several of our corporate
collaborators.
Collaborations and Licenses
We intend to continue to seek research and development
collaborations with multiple pharmaceutical and biotechnology
companies to develop and commercialize therapeutic and
prophylactic vaccines for select infectious disease and tumor
types. Our unique capabilities include expertise in identifying
those epitopes from viral and tumor-associated antigens that
elicit the desired immune response as well as expertise in
creating and evaluating product candidates that elicit a potent
immune response.
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Collaboration and Technology In-License Agreements |
Bavarian Nordic A/ S. In November 2001, we entered into a
collaboration agreement with Bavarian Nordic A/ S to combine our
technology and expertise in the fields of T cell epitope
identification and vaccine design with Bavarian Nordics
vaccine delivery technology and manufacturing expertise to
develop vaccines
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for the treatment or prevention of HIV infection. We will share
equally with Bavarian Nordic in all research related expenses
during the five-year term of this collaboration.
Innogenetics N.V. We have a collaboration with
Innogenetics N.V. pursuant to which we exclusively licensed to
Innogenetics our PADRE® and epitope technologies for
vaccines to treat or prevent hepatitis B, hepatitis C and
human papilloma virus. We originally entered into this
collaboration with Genencor International, Inc. in July 2001. In
connection with the original collaboration, we received an
upfront license fee and Genencor made an initial ten percent
equity investment in our common stock at a premium to the market
price. Under this agreement, we may receive a total of
approximately $60 million in payments, including the
initial equity investment by Genencor but excluding royalties.
In January 2002, we received a payment from Genencor for
achievement of our first milestone, identification of a product
candidate to treat chronic hepatitis B infection. In February
2004, we announced that we had earned a milestone payment
form Genencor as a result of Genencor filing an IND for a
vaccine to treat hepatitis B. In addition, Genencor (now
Innogenetics) fully funds our research in these specific
indications and is obligated to pay us royalties on sales of any
products that may be developed under the collaboration. The
initial collaboration had a term through September 2003, and in
October 2002, was extended to September 2004. In March 2004,
Genencor assigned its rights under our collaboration to
Innogenetics. In connection with the assignment by Genencor, we
extended the collaboration term with Innogenetics through
September 2005. In addition, Genencor agreed not to sell or
otherwise dispose of any of our common stock they held, without
our prior approval, for a minimum of twelve months. Innogenetics
has the right to terminate the agreement early, upon three
months written notice, if we breach our obligations under the
collaboration agreement or upon certain force majeure events.
Valentis, Inc. In December 2000, as amended in October
2002, we licensed gene delivery technology on a nonexclusive
basis from Valentis, Inc. for preventive and therapeutic DNA
vaccines against HIV and hepatitis C virus. In October
2002, we licensed the same gene delivery technology on a
nonexclusive basis from Valentis for preventive and therapeutic
DNA vaccines against cancer. In connection with both licenses,
we paid an upfront license fee and will make payments to
Valentis upon achievement of certain clinical milestones and pay
royalties on sales of any products incorporating the Valentis
technology.
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License Option Agreements |
Merck & Co. In April 2003, we entered into an
agreement with Merck & Co., Inc. under which Merck will
evaluate select Epimmune epitopes in connection with technology
controlled by Merck for the development of certain vaccines.
Under the terms of the agreement, we provided Merck a limited
number of our proprietary analog, or modified, epitopes, which
will then be evaluated in connection with delivery technologies
owned or controlled by Merck to determine the activity of the
Epimmune epitopes. We received an evaluation license fee in
connection with the agreement. Merck has an option to enter into
licensing discussions with us for the development of the
Epimmune epitopes for use in vaccines for the treatment of
certain diseases.
Beckman Coulter, Inc. In January 2003, we entered into an
option and license agreement with Beckman Coulter, Inc. under
which Beckman Coulter had the right to acquire a non-exclusive,
worldwide license to certain Epimmune epitopes on an
epitope-by-epitope basis for certain infectious diseases and
cancer indications. Beckman Coulter had the right to use these
epitopes for research and diagnostic applications in connection
with their MHC Tetramer and other immune response monitoring
technologies. Under the terms of the agreement, we were entitled
to annual option fees. In the event that Beckman Coulter
exercised its option to acquire a license to any specific
epitope, we were entitled to additional license fees for each
epitope and royalties on product sales in the event any products
were commercialized using our technology. Beckman Coulter paid
us the annual option fee in 2004 and in January 2005 they
notified us that they would not be exercising their option to
extend the term of the agreement.
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License Agreements for Technology Outside our Areas of
Focus |
Amgen. In September 2003, we entered into an agreement
with Amgen Inc. under which Amgen acquired a non-exclusive
license to our PADRE® technology for research use. In
connection with the agreement, we received a license fee.
Immuno-Designed Molecules, S.A. In February 2003, we
entered into a license agreement with IDM whereby we granted IDM
a non-exclusive license to certain patented and non-patented
rights to our universal cancer epitope packages for use in
connection with IDMs
Dendritophagetm
ex vivo technology. In connection with the agreement, we
received an upfront license fee and are also entitled to receive
commercialization milestone payments and royalties on product
sales if IDM develops products using our technology.
Anosys Inc. In August 2001, we entered into a license
agreement with Anosys Inc., formerly AP Cells, granting Anosys a
non-exclusive license to certain cancer antigens and associated
technology for use in ex vivo cell therapy. In connection
with the agreement, we received an upfront license fee and are
also entitled to receive milestone and royalty payments on
product sales, if any products are developed. In September 2003,
we received a milestone payment under the agreement as a result
of Anosys filing of an IND for a product incorporating the
technology we licensed them.
Pharmexa A/ S. In June 2001, we entered into a license
agreement with Pharmexa A/ S granting Pharmexa a non-exclusive
license to our PADRE® technology for use in connection with
Pharmexas
AutoVactm
technology for controlling autoimmune diseases. In connection
with the agreement, we received an upfront license fee and are
also entitled to receive milestone and royalty payments on
product sales, if any products are developed. In December 2004,
we amended the license agreement to expand the indications for
which Pharmexa could use our PADRE® technology. In
connection with the amendment, we received an additional upfront
license fee.
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Government Research Funding |
In May 2004, we received a grant from the National Cancer
Institute, or NCI, an institute of the NIH, to support our
continuing and detailed analysis of the immune responsiveness of
patients immunized with our multi-epitope cancer vaccine
candidate, EP-2101, in the Phase I/ II clinical trials we
conducted with the vaccine. The grant has a total potential
value of approximately $0.8 million over two years.
In March 2004, we received a grant from the NCI to define and
conduct preclinical testing of a multi-epitope, clinical vaccine
candidate for ovarian and breast cancer. We are collaborating
with investigators at the University of Washington on the
program with an objective of designing a vaccine to induce HTL
responses directed against multiple tumor associated antigens in
order to prevent or delay disease recurrence after surgery and
chemotherapy. The Phase I grant has a total potential value
of approximately $0.6 million over two years. From the
Phase I program, it is contemplated that a multi-epitope
based vaccine will be designated for development and clinical
testing in a potential Phase II program.
In September 2003, we were awarded a $16.7 million,
five-year contract from the National Institute of Allergy and
Infectious Diseases, or NIAID, an institute of the NIH for the
design and development of prophylactic HIV vaccines for clinical
evaluation by the NIAID-sponsored HIV Vaccine Trials Network, or
HVTN. The award was made under the NIAIDs HIV Vaccine
Design and Development Teams, or HVDDT, program whose goal is to
fund development of promising vaccine concepts with plans for
targeted testing in humans. Epimmune is leading a consortium
that includes Bavarian Nordic A/ S in Denmark and SRI
International and Althea Technologies, both in the
U.S. Epimmune is using its proprietary epitope technology
to identify epitopes, or protein fragments, from conserved
regions of multiple HIV virus proteins for use in candidate
vaccines.
In July 2003, we received a grant from the NCI to support
continued epitope analog identification and preclinical
development of multi-epitope, analog based cancer vaccines. The
grant has a total potential value of approximately
$0.6 million over two years. The activities funded by this
grant complement current studies and Phase I/ II clinical
trials we are conducting by providing analog epitopes that
extend vaccine coverage to
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larger segments of the population. This grant was made under the
National Cancer Institutes Flexible System to Advance
Innovative Research for Cancer Drug Discovery by Small Business,
or FLAIR Program.
In October 2002, we were awarded a contract from NIAID to
conduct research and development aimed at developing a malaria
vaccine. The award is part of the NIAIDs Millennium
Vaccine Initiative that solicits vaccine technology from the
private sector to accelerate the development of effective
vaccines for malaria and tuberculosis. The program is composed
of a Phase A feasibility study and an option for a Phase B
development program for a total potential value of
$3.5 million over five years. We are working with
investigators at the Naval Medical Research Center on the
program. In July 2004, we received written notice from the NIAID
exercising the three-year Phase B option for us to conduct
preclinical development of a multi-epitope malaria vaccine. The
NIAID decision followed our meeting predetermined Phase A
criteria in which we demonstrated the preclinical feasibility of
a vaccine that would target malaria in all human ethnicities.
The objective of the Phase B preclinical development program is
to design a vaccine candidate suitable for human testing.
In August 2000, we were awarded a $3.8 million grant from
the Integrated Preclinical/ Clinical Program of the NIH,
Division of AIDS, for the development of our vaccine to treat
people infected with HIV. Pursuant to the terms of the grant,
the government agreed to fund a four-year program designed to
evaluate Epimmunes epitope-based vaccines as a therapeutic
strategy for the treatment of HIV-1-infected individuals on
highly active antiretroviral therapy. The current Phase I/
II clinical trial for the treatment of HIV, as well as earlier
preclinical activities, is being sponsored in part by this
grant. In June 2004, we received a one-year, no-cost extension
of this grant to allow us to complete certain activities on this
program.
Patents, Proprietary Rights and Licenses
Our success will depend in part on our ability to obtain patents
having claims directed to our products and processes, both in
the United States and other countries. The patent position of
biotechnology and pharmaceutical companies is highly uncertain
and involves complex legal and factual questions. We file patent
applications, as we believe appropriate, that cover our
proprietary technology.
We have developed our patent portfolio over approximately the
past eleven years. The patents and patent applications in our
patent portfolio include claims directed to specific disease
epitopes, epitope identification, epitope analogs, methods for
identifying epitopes and epitope analogs, vaccine design,
specific vaccines, our PADRE® universal HTL epitope and
ImmunoStealth epitope modification technologies. As of
March 7, 2005, our intellectual property portfolio,
including licenses to intellectual property relevant to epitope
discovery and gene delivery, included approximately 30 issued
United States patents, 170 granted foreign patents, 60
applications pending in the United States and 180 foreign
applications pending.
These patent applications and patents in the portfolio are owned
by or are under license to us. We cannot be certain that patents
will issue from the patent applications we have filed or
licensed, or that if patents do issue, that issued claims in
those patents will be sufficiently broad to exclude others from
making or using our products and processes. In addition, we
cannot be certain that third parties will not challenge,
invalidate or circumvent any patents issued to us, or that the
rights granted thereunder are sufficiently broad to exclude
others from making or using our products and processes.
As is typical in the biotechnology industry, our commercial
success will depend in part on our ability to avoid infringing
patents issued to competitors or breaching the technology
licenses upon which we might base our products. If we fail to
obtain a license to any technology that we require to
commercialize our products, or to develop an alternative
compound and obtain regulatory approval within an acceptable
period of time if required to do so, our business would be
harmed. Litigation or the threat of litigation, which could
result in substantial costs to us, may also be necessary to
enforce the claims in any patents issued to us, to defend
ourselves against any patents owned by third parties that are
asserted against us, or to determine the scope and validity of
others proprietary rights. In addition, we may have to
participate in one or more interference proceedings declared by
the United States Patent and Trademark Office, which could
result in substantial costs to determine the priority of
inventorship.
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If we become involved in litigation or interference proceedings,
we may incur substantial expense, and the proceedings may divert
the attention of our technical and management personnel, even if
we ultimately prevail. An adverse determination in proceedings
of this type could subject us to significant liabilities, allow
our competitors to market competitive products without obtaining
a license from us, prohibit us from marketing vaccines or other
products or require us to seek licenses from third parties that
may not be available on commercially reasonable terms, if at
all. If we cannot obtain such licenses, we may be restricted or
prevented from developing and commercializing our product
candidates.
We also attempt to protect our proprietary products and
processes in part by confidentiality agreements with our
collaborative partners, employees and consultants. These
agreements may be breached, and we may not have adequate
remedies for any breach, and our trade secrets may become known
or be independently discovered by competitors.
Competition
The biotechnology industry continues to undergo rapid change and
competition is intense and is expected to increase. Our
competitors may succeed in developing technologies and products
that are more effective or affordable than any of the products
we are developing or which would render our technology and
products obsolete and noncompetitive. We compete with many
public and private companies, including pharmaceutical
companies, chemical companies, specialized biotechnology
companies and academic institutions. There are 27 drugs
currently approved in the United States for HIV infection/ AIDS,
and according to a PhRMA 2003 report on pharmaceutical
drug development, there were 83 new product candidates in
clinical development for HIV and related conditions, including
15 HIV vaccines. In addition, according to the PhRMA 2003
report, there were 395 new product candidates in clinical
development for the treatment of cancer, and at least
30 companies were developing more than 50 vaccines against
various cancers. Many of our competitors have substantially
greater experience, financial and technical resources and
production, marketing and development capabilities than us. In
addition, many of our competitors have significantly greater
experience conducting preclinical studies and clinical trials of
new products, and in obtaining regulatory approvals for such
products. Accordingly, some of our competitors may succeed in
obtaining, developing and commercializing products more rapidly
or effectively than us, or in developing technology and products
that would render our technology and products obsolete or
noncompetitive. We are aware of companies that are pursuing the
development of pharmaceuticals that target the same diseases
that we are targeting. These and other efforts by potential
competitors may be successful, and other technologies may be
developed to compete with our technologies. If we cannot
successfully respond to technological change in a timely manner,
our commercialization efforts may be harmed.
In addition, our products under development address a range of
markets. Almost all large pharmaceutical companies have programs
for infectious diseases and cancer. Our competition will
ultimately be determined in part by the potential indications
for which our compounds are developed and ultimately approved by
regulatory authorities. An important factor in competition may
be the timing of market introduction of our products and
competitive products. Accordingly, the relative speed with which
we can develop products, complete the clinical trials and
approval processes and supply commercial quantities of the
products to the market are expected to be important competitive
factors. We expect that competition among products approved for
sale will be based, among other things, on product
effectiveness, safety, reliability, availability, price and
patent position.
Our competitive position also depends upon our ability to
attract and retain qualified personnel, obtain patent protection
or otherwise develop proprietary products or processes and
secure sufficient capital resources for the often-substantial
period between technological conception and commercial sales.
Government Regulation
Our research and development activities and any future
manufacturing and marketing of our products are subject to
regulation for safety and efficacy by numerous governmental
authorities in the United States and other countries. In the
United States, drugs are subject to rigorous regulation by the
Food and Drug
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Administration, or FDA. The process from development to approval
typically takes between 7 and 12 years, depending upon the
type, complexity and novelty of the pharmaceutical product. The
Federal Food, Drug and Cosmetic Act and the Public Health
Service Act govern the testing, manufacture, safety, efficacy,
labeling, storage, record keeping, approval, advertising and
promotion of our products. In addition to FDA regulations, we
are also subject to other federal and state regulations such as
the Occupational Safety and Health Act and the Environmental
Protection Act. Product development and approval within this
regulatory framework involves the expenditure of substantial
resources. In addition, this regulatory framework may change and
additional regulation may arise at any stage of our product
development, which may affect approval or delay an application
or require additional expenditures.
The steps required before a pharmaceutical agent may be marketed
in the United States include:
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preclinical laboratory and animal tests, |
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the submission to the FDA of an application for an IND, which
must become effective before human clinical trials may commence
in the United States, |
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adequate and well-controlled human clinical trials to establish
the safety and efficacy of the drug, |
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the submission of a new drug application, or NDA, or a biologic
license application, or BLA, to the FDA, and |
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the FDA approval of the NDA or BLA prior to any commercial sale
or shipment of the drug. |
In addition to obtaining FDA approval for each product, each
domestic drug-manufacturing establishment must be registered
with, and approved by, the FDA. Drug product manufacturing
establishments located in California also must be licensed by
the state of California in compliance with separate regulatory
requirements.
Preclinical tests include laboratory evaluation of product
chemistry and animal studies to assess the safety and efficacy
of the product and its formulation. The results of the
preclinical tests are submitted to the FDA as part of an IND and
subsequently when additional non-clinical work is completed and,
unless the FDA objects, the IND will become effective
30 days following its receipt by the FDA. Submission of an
IND may never result in the commencement of human clinical
trials.
Clinical trials involve the administration of the drug under the
supervision of a qualified principal investigator to healthy
volunteers or to patients identified as ones with the condition
for which the drug is being tested. Clinical trials are
conducted in accordance with protocols that detail the
objectives of the study, the parameters to be used to monitor
safety and the efficacy criteria to be evaluated. Each protocol
is submitted to the FDA as part of the IND. Each clinical study
is conducted under the auspices of an independent Institutional
Review Board, or IRB, at the institution at which the study will
be conducted. Prior to its approval for the study to be
conducted, the IRB will consider, among other things, ethical
factors, the safety of human subjects and the possible liability
of the institution.
Clinical trials are typically conducted in three sequential
phases prior to product approval, but the phases may overlap, be
repeated or subdivided. Phase I involves the initial
introduction of the drug into healthy human subjects and often
into patients as well. In Phase I, the drug is tested for
safety (adverse effects), dosage tolerance, metabolism,
distribution, excretion and clinical pharmacology. Phase II
involves studies in a limited patient population to:
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determine the effectiveness of the drug for specific targeted
indications, |
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determine dosage tolerance and optimal dosage and
regimen, and |
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identify possible adverse side effects and safety risks. |
When a compound is found to be effective and to have an
acceptable safety profile in Phase II evaluations,
Phase III trials are undertaken to evaluate clinical
efficacy further and to test further for safety within an
expanded patient population at multiple clinical study sites.
Even after NDA or BLA approval, the
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FDA may require additional Phase IV clinical trials. The
FDA reviews both the clinical plans and the results of the
trials and may discontinue the trials at any time if there are
significant safety issues.
The results of the preclinical tests and clinical trials and
other data are submitted to the FDA in the form of an NDA or BLA
for marketing approval. The testing and approval process is
likely to require substantial time and effort and any approval
may not be granted on a timely basis, or may not be granted at
all. The approval process is affected by a number of factors,
including the severity of the disease, the availability of
alternative treatments and the risks and benefits demonstrated
in clinical trials. Additional animal studies or clinical trials
may be requested during the FDA review period and may delay
marketing approval. After FDA approval for the initial
indications, further clinical trials may be necessary to gain
approval for the use of the product for additional indications.
The FDA mandates that adverse effects be reported to the FDA and
may also require post-marketing testing to monitor for adverse
effects, which can involve significant expense.
Among the conditions for NDA or BLA approval is the requirement
that the prospective manufacturers quality control and
manufacturing procedures conform to good manufacturing practices
prescribed by the FDA. Domestic manufacturing facilities are
subject to FDA inspections twice yearly and foreign
manufacturing facilities are subject to periodic FDA inspections
or inspections by the foreign regulatory authorities with
reciprocal inspection agreements with the FDA.
The Prescription Drug User Fee Act of 1992, as amended, requires
companies engaged in pharmaceutical development, such as our
company, to pay user fees in the amount of at least $100,000
upon submission of an NDA. We do not believe that this
requirement will harm our business.
For marketing outside the United States, we are also subject to
foreign regulatory requirements governing human clinical trials
and marketing approval for drugs. The requirements governing the
conduct of clinical trials, product licensing, pricing and
reimbursement vary widely from country to country.
The time required for completing such testing and obtaining such
approvals is uncertain and approval itself may not be obtained.
In addition, delays or rejections may be encountered based upon
changes in FDA policy during the period of product development
and FDA regulatory review of each submitted NDA or BLA. Similar
delays may also be encountered in foreign countries. Even after
such time and expenditures, regulatory approval may not be
obtained for any drugs that we develop. Moreover, if regulatory
approval of a drug is granted, such approval may entail
limitations on the indicated uses for which the drug may be
marketed. Further, even if such regulatory approval is obtained,
a marketed drug, its manufacturer and the facilities in which
the drug is manufactured are subject to continual review and
periodic inspections. Later discovery of previously unknown
problems with a product, manufacturer or facility may result in
restrictions on such product or manufacturer, including
withdrawal of the product from the market.
Manufacturing
To be successful, our products and the products of our partners
must be manufactured in commercial quantities in compliance with
regulatory requirements and at an acceptable cost. We have not
commercialized any products, nor have we demonstrated that we
can manufacture commercial quantities of our product candidates
or our partners product candidates in accordance with
regulatory requirements. If we cannot manufacture products in
suitable quantities in accordance with regulatory standards,
either on our own our through contracts with third parties, it
may delay clinical trials, regulatory approvals and marketing
efforts for such products. Such delays could adversely affect
our competitive position and our chances of achieving
profitability. We cannot be sure that we can manufacture, either
on our own or through contracts with third parties, such
products at a cost or in quantities, which are commercially
viable. We currently rely and intend to continue to rely on
third-party contract manufacturers to produce materials needed
for clinical trials and, ultimately, for product
commercialization.
Employees
As of March 29, 2005, we employed 37 individuals full-time,
of whom 27 were engaged in research and development, and 11 of
whom hold Ph.D. or M.D. degrees. A significant number of our
management and
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professional employees have had prior experience with
pharmaceutical, biotechnology or medical product companies. None
of our employees are covered by collective bargaining
agreements, and management considers relations with our
employees to be good.
Available Information
Our website address is www.epimmune.com. We make
available free of charge through our website our annual report
on Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K, and all amendments to these
reports as soon as reasonably practicable after such material is
electronically filed with or furnished to the Securities and
Exchange Commission.
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RISK FACTORS
We wish to caution readers that the following important
factors, among others, in some cases have affected our results
and in the future could cause our actual results and needs to
vary materially from forward-looking statements made from time
to time by us on the basis of managements then-current
expectations. The business in which we are engaged is in rapidly
changing and competitive markets and involves a high degree of
risk, and accuracy with respect to forward-looking projections
is difficult.
Our substantial additional financing requirements and limited
access to financing may adversely affect our ability to develop
products and fund our operations.
We will continue to spend substantial amounts on research and
development, including amounts spent for manufacturing clinical
supplies, conducting clinical trials for our product candidates
and advancing development of certain sponsored and partnered
programs. Therefore, we will need to secure additional funding,
in addition to the approximately $5.5 million we raised in
April 2004. We do not have committed external sources of funding
and may not be able to obtain any additional funding, especially
if volatile market conditions persist for biotechnology
companies. If we are unable to obtain additional funding, we
will be required to delay, further reduce the scope of or
eliminate one or more of our research and development projects,
sell the Company or certain of its assets or technologies, or
dissolve and liquidate all of its assets. As of
December 31, 2004, we had approximately $7.0 million
in cash and cash equivalents. We have incurred and will continue
to incur legal, accounting and other transaction costs in
connection with our proposed combination with IDM. If we do not
complete the proposed combination as planned, our cash position
will be further reduced, and it will likely be even more
difficult to raise additional funding on satisfactory terms, if
at all. Our future operational and capital requirements will
depend on many factors, including:
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whether our proposed transaction with IDM is successfully
completed; |
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whether we are able to secure additional financing on favorable
terms, or at all; |
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the costs associated with our ongoing Phase I/ II clinical
trial for our vaccine targeting HIV, which began in September
2002, including the status of our contract with the NIH; |
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the costs associated with our Phase II clinical trial for
our vaccine targeting NSCLC, which began in December 2004; |
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progress with other preclinical testing and clinical trials in
the future; |
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our ability to establish and maintain collaboration and license
agreements and any government contracts and grants; |
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the actual revenue we receive under our collaboration and
license agreements; |
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the actual costs we incur under our research collaboration with
Bavarian Nordic; |
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the time and costs involved in obtaining regulatory approvals; |
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the costs involved in filing, prosecuting, enforcing and
defending patent claims and any other proprietary rights; |
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competing technological and market developments; |
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changes in our existing research relationships; |
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continued scientific progress in our drug discovery
programs; and |
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the magnitude of our drug discovery and development programs. |
We intend to seek additional funding through collaboration and
license agreements, government research grants and contracts, or
equity or debt financings. In the event we are able to obtain
financing, it may not be on favorable terms. In addition, we may
not be able to enter into additional collaborations to reduce
our funding requirements. If we acquire funds by issuing
securities, dilution to existing stockholders will result, such
as the
16
dilution that occurred as a result of our most recent financing
in April 2004. If we raise funds through additional
collaborations and license agreements, we will likely have to
relinquish some or all of the rights to product candidates or
technologies that we may have otherwise developed ourselves. If
we are unable to obtain funding, we may be required to engage in
another restructuring, cease development of some product
candidates, further reduce the scope of our operations, sell the
Company or certain of its assets or technologies or cease
operations.
We may not meet all of The Nasdaq National Markets
continued listing requirements and we may be delisted, which
could reduce the liquidity of our common stock and adversely
affect our ability to raise additional necessary capital.
In order to continue trading on The Nasdaq National Market, we
must comply with The Nasdaq National Markets continued
listing requirements, which require that we maintain a minimum
stockholders equity of $10.0 million and a minimum
closing bid price of $1.00 per share. Our
stockholders equity was $9.3 million and
$9.7 million as of March 31, 2004 and
December 31, 2003, respectively, which did not satisfy the
$10.0 million continued listing requirement. As of
December 31, 2004, our stockholders equity was
$11.1 million and we satisfy the $10.0 million
continued listing requirement as of the date of filing of this
report. There is a significant risk that we will not meet the
stockholders equity requirement in the future if we do not
complete the IDM transaction. The Nasdaq National Market will
monitor our ongoing compliance with listing requirements. If we
fail to satisfy The Nasdaq National Markets continued
listing requirements at the time of our next quarterly report on
Form 10-Q or at any other time in the future, our common
stock may be delisted from The Nasdaq National Market. The
delisting of our common stock may result in the trading of the
stock on The Nasdaq SmallCap Market or the OTC
Bulletin Board. Consequently, a delisting of our common
stock from The Nasdaq National Market may reduce the liquidity
of our common stock and adversely affect our ability to raise
additional necessary capital.
The process of developing therapeutic products requires
significant research and development, preclinical testing and
clinical trials, all of which are extremely expensive and
time-consuming and may not result in a commercial product.
Except for our HIV and NSCLC and colorectal cancer vaccine
candidates, for which we began clinical trials in September 2002
and February 2003 respectively, all of our potential vaccine
products are in research or preclinical development, the results
of which do not necessarily predict or prove safety or efficacy
in humans. We must demonstrate for each vaccine, safety and
efficacy in humans through extensive clinical testing, which is
very expensive, can take many years, and has an uncertain
outcome. We may experience numerous unforeseen events during or
as a result of the testing process that could delay or prevent
testing or commercialization of our products, including the
following:
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the results of preclinical studies may be inconclusive, or they
may not be indicative of results that will be obtained in human
clinical trials; |
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after reviewing test results, we or our collaborators may
abandon projects that we might previously have believed to be
promising; |
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we, our collaborators or regulators may suspend or terminate
clinical trials if the participating subjects or patients are
being exposed to unacceptable health risks; |
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we may have to delay clinical trials as a result of scheduling
conflicts with participating clinicians and clinical
institutions, or difficulties in identifying and enrolling
patients who meet trial eligibility criteria; |
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safety and efficacy results attained in early human clinical
trials may not be indicative of results that are obtained in
later clinical trials; and |
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the effects our vaccine candidates have may not be the desired
effects or may include undesirable side effects or other
characteristics that preclude regulatory approval or limit their
commercial use if ever approved. |
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The data collected from clinical trials may not be sufficient to
support regulatory approval of any of our products, and the
U.S. Food and Drug Administration, or FDA may not
ultimately approve any of our therapeutic products for
commercial sale, which will adversely affect our revenues and
prospects. If we fail to commence or complete, or experience
delays in, any of our planned clinical trials, our operating
income, our stock price and our ability to conduct our business
as currently planned could be harmed.
Some of our programs are funded by the U.S. government
and the government may not allocate funds for these programs in
future fiscal years.
We fund certain of our research and development related to our
HIV, cancer and malaria programs pursuant to multi-year grants
and contracts from the U.S. government. The government is
under no obligation to and may not fund these programs over
their full term which would have a significant impact on our
ability to continue development of our HIV, cancer and malaria
programs.
Our history of operating losses and our expectations of
continuing losses may hurt our ability to reach profitability or
continue operations.
We have experienced significant operating losses since our
inception in 1987. As of December 31, 2004, we had an
accumulated deficit of $161.8 million. We expect to
continue to incur substantial operating expenses and net
operating losses for the foreseeable future, which may hurt our
ability to continue operations. We have not generated revenues
from the commercialization of any product. All of our revenues
to date have consisted of contract research and development
revenues, license and milestone payments, research grants,
certain asset divestitures and interest income. We expect that
substantially all of our revenues for the foreseeable future
will result from similar sources. To achieve profitable
operations, we, alone or with collaborators, must successfully
identify, develop, register and market proprietary products. We
do not expect to generate revenues from the commercialization of
any product for at least six years (and this would assume
approval of either our HIV or lung cancer product candidates,
which may not occur). We may not be able to generate sufficient
product revenue to become profitable. Even if we do achieve
profitability, we may not be able to sustain or increase our
profitability on a quarterly or yearly basis.
We are at an early stage of development, and we may
experience delays and other problems in entering clinical
trials.
We are an early stage research and development company, and only
commenced our first Phase I/ II clinical trials for one of
our vaccines within the past two years, and a Phase II
trial for one of our vaccines in December 2004. There are many
factors outside of our control that may affect the timing of
completion of our current clinical trials, and any future
clinical trials may not commence when planned or be completed
within any anticipated time frame. For example, in the past we
experienced unexpected delays in filing an investigative new
drug application, or IND for our therapeutic vaccine candidate
targeting HIV, due to additional time necessary to complete all
of the animal safety studies that were contemplated in our
pre-IND discussions with the FDA. We may experience unexpected
delays in our research and development efforts that would
require us to postpone the commencement or completion of
clinical trials of other vaccine candidates. The FDA may comment
or raise concerns or questions with respect to any IND that we
file and, therefore, clinical trials may not begin when planned,
if at all.
Unexpected side effects or other characteristics of our
technology may delay or otherwise hurt the development of our
vaccine candidates.
There may be side effects in our current or future clinical
trials that we may discover, including side effects that become
apparent only after long-term exposure, even though our safety
tests may indicate favorable results. We may also encounter
technological challenges relating to these technologies and
applications in our research and development programs that we
may not be able to resolve. Any such unexpected side effects or
technological challenges may delay or otherwise adversely affect
the development, regulatory approval or commercialization of our
drug candidates.
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There are no therapeutic vaccines that have been approved for
use by the FDA and our vaccines may not work, which would
prevent us from ever becoming profitable.
Because there are not yet any therapeutic vaccines that have
undergone the complete clinical development process and FDA
review, there is still insufficient evidence that therapeutic
vaccines will become products. Our business is dependent upon
the concept of therapeutic vaccines and, therefore, if
therapeutic vaccines were found not to be safe or effective, we
would never commercialize a product candidate and would never
make a profit.
Adverse publicity regarding the safety or side effects of the
technology approach or products of others could reduce our
revenues and cause our stock price to fall.
Despite any favorable safety tests that may be completed with
respect to our product candidates, adverse publicity regarding
vaccines or products being developed or marketed by others could
negatively affect us. If other researchers studies raise
or substantiate concerns over the safety or side effects of
vaccines or our technology approach or product development
efforts generally, our reputation and public support for our
clinical trials or products could be harmed, which would harm
our business and could cause our stock price to fall.
Our research and development programs may not yield effective
product candidates, which could prevent us from developing our
products.
We cannot guarantee that our research and development programs
will be successful in identifying vaccine candidates for
clinical trials. Even if we do receive positive data during
preclinical testing and during Phase I/ II clinical trials
for our therapeutic vaccine candidate targeting HIV, and
Phase II clinical trials targeting lung cancer, or any
other candidates we may develop, this data cannot be relied upon
as evidence that the clinical candidate will be safe and
effective in humans, and assuming we initiate any Phase III
trials, data from Phase III or other pivotal clinical
trials may not be consistent with earlier data or be sufficient
to support regulatory approval.
We may not identify the correct epitopes and, therefore, not
develop a safe or effective vaccine.
Our strategy involves identifying multiple epitopes in order to
create our vaccines. If we are unable to identify the correct
epitopes, or if we are unable to combine them in the correct
manner, to stimulate desired immune responses we may never
develop a vaccine that is safe or effective in any of the
indications that we are pursuing.
Our business is based on a novel technology, which has not
been used in any commercial drugs, and may not work.
Our vaccine candidates use epitopes to stimulate specific T cell
immune responses, but we are not aware of any commercial drugs
that are based on this technology. Our technology related to T
cell stimulation is unproven and may not produce any commercial
vaccines.
Our failure to obtain issued patents and, consequently, to
protect our proprietary technology, could hurt our competitive
position.
Our success will depend in part on our ability to obtain and
enforce claims in our patents directed to our products,
technologies and processes, both in the United States and other
countries. Although we have filed various patent applications,
our patent position is highly uncertain and involves complex
legal and factual questions. Legal standards relating to
patentability, validity and scope of patent claims in epitope
identification and other aspects of our technology field are
still evolving. Patents may not issue from any of the patent
applications that we own or license and, if patents do issue,
claims issued in the patents may not be sufficiently broad to
protect our vaccines, technologies and processes. For example,
even though our patent portfolio includes patent applications
with claims directed to peptide epitopes and methods of
utilizing sequence motifs to identify peptide epitopes, we
cannot assure you of the breadth of claims that will be allowed
or that may
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issue in future patents. Other risks and uncertainties that we
face with respect to our patents and patent applications include
the following:
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the pending patent applications we have filed or to which we
have exclusive rights may not result in issued patents or may
take longer than we expect to result in issued patents; |
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the allowed claims of any patents that issue may not provide
meaningful protection; |
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we may be unable to develop additional proprietary technologies
that are patentable; |
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the patents licensed or issued to us may not provide a
competitive advantage; |
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other companies may challenge patents licensed or issued to us; |
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disputes may arise regarding inventions and corresponding
ownership rights in inventions and know-how resulting from the
joint creation or use of intellectual property by us, our
licensors, or collaborators; and |
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other companies may design around our patented technologies. |
Our competitors may develop products that are more effective
and that render our potential products obsolete.
The biotechnology industry continues to undergo rapid change,
and competition is intense and is expected to increase. Our
competitors may succeed in developing technologies, vaccines or
other therapeutic products that are more effective than any of
the products we are developing, which would render our
technology and products obsolete and noncompetitive.
If we are unable to compete effectively in the highly
competitive biotechnology industry, our business will fail.
Many companies and institutions compete with us in developing
vaccines and other therapies to activate the bodys immune
system or to otherwise treat or more effectively manage
infectious diseases and cancer, including:
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pharmaceutical companies; |
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chemical companies; |
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specialized biotechnology companies; |
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academic institutions; and |
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research organizations. |
Many of the companies developing competing technologies and
products have significantly greater financial resources and
expertise in research and development, manufacturing,
preclinical and clinical development, obtaining regulatory
approvals and marketing than we do, and we may not be able to
compete effectively against them.
Our vaccines under development address a range of cancer and
infectious disease markets. The competition in these markets is
extremely formidable. There are 27 drugs currently approved in
the United States for HIV and according to a PhRMA 2003
report on pharmaceutical drug development, there were 83 new
product candidates in clinical development for HIV and related
conditions, including 15 HIV vaccines. In addition, according to
the PhRMA 2003 report, there were 395 new product
candidates in clinical development for the treatment of cancer,
and at least 30 companies were developing more than 50
vaccines against various cancers. An important factor in
competition may be the timing of market introduction of our
vaccines and competitive products. Accordingly, the relative
speed with which we can develop vaccines, complete the clinical
trials and approval processes and supply commercial quantities
of the vaccines to the market are expected to be important
competitive factors. We expect that competition among products
approved for sale
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will be based, among other things, on product effectiveness,
safety, reliability, availability, price and patent position.
Litigation regarding intellectual property rights owned or
used by us may be costly and time-consuming.
Litigation may be necessary to enforce the claims in any patents
issued to us, to defend ourselves against any patents owned by
third parties that are asserted against us, or to determine the
scope and validity of others proprietary rights. In
addition, we may have to participate in one or more interference
proceedings declared by the United States Patent and Trademark
Office, which could result in substantial costs to determine the
priority of inventions.
If we become involved in litigation or interference proceedings,
we may incur substantial expense, and the proceedings may divert
the attention of our technical and management personnel, even if
we ultimately prevail. An adverse determination in proceedings
of this type could subject us to significant liabilities, allow
our competitors to market competitive products without obtaining
a license from us, prohibit us from marketing vaccines or other
products or require us to seek licenses from third parties that
may not be available on commercially reasonable terms, if at
all. If we cannot obtain such licenses, we may be restricted or
prevented from developing and commercializing our product
candidates.
The enforcement, defense and prosecution of intellectual
property rights, United States Patent and Trademark Office
interference proceedings and related legal and administrative
proceedings in the United States and elsewhere involve complex
legal and factual questions. As a result, these proceedings are
costly and time-consuming, and their outcome is uncertain.
Litigation may be necessary to:
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assert against others or defend ourselves against claims of
infringement; |
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enforce patents in our portfolio owned by us or licensed from
another party; |
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protect our trade secrets or know-how; or |
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determine the enforceability, scope and validity of the
proprietary rights of ours or others. |
If we cannot obtain and maintain strategic collaborations on
acceptable terms in the future, we may not be able to develop
products in markets where it would be too costly or complex to
do so on our own.
We will need to enter into and maintain collaborative
arrangements with pharmaceutical and biotechnology companies or
other strategic partners both for development and
commercialization of potential vaccine products in markets where
it would be too costly or complex to do so on our own.
Currently, our only collaborations are with Innogenetics and
Bavarian Nordic. If we are not able to enter into and maintain
additional research and development collaborations or other
collaborations in the future on acceptable terms, we may be
forced to abandon development and commercialization of some
vaccine product candidates.
If our collaboration or license arrangements are
unsuccessful, our revenues and product development may be
limited.
Our collaborations and license arrangements generally pose the
following risks:
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collaborators and licensees may not pursue further development
and commercialization of potential products resulting from our
collaborations or may elect not to renew research and
development programs; |
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collaborators and licensees may delay clinical trials,
under-fund a clinical trial program, stop a clinical trial or
abandon a product candidate, repeat or conduct new clinical
trials or require new formulation of a product candidate for
clinical testing; |
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expected revenue might not be generated because milestones may
not be achieved and product candidates may not be developed; |
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collaborators and licensees could independently develop, or
develop with third parties, products that could compete with our
future products; |
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the terms of our contracts with our current or future
collaborators and licensees may not be favorable to us in the
future; |
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a collaborator or licensee with marketing and distribution
rights to one or more of our products may not commit enough
resources to the marketing and distribution of our products,
limiting our potential revenues from the commercialization of a
product; |
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disputes may arise delaying or terminating the research,
development or commercialization of our product candidates, or
result in significant and costly litigation or
arbitration; and |
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collaborations and licensee arrangements may be terminated and
we will experience increased operating expenses and capital
requirements if we elect to pursue further development of the
product candidate. |
We may not be able to obtain licenses to technology that is
necessary for us to develop products.
We may be required to enter into licenses or other
collaborations with third parties in order to access technology
that is necessary to successfully develop certain of our
products. We may not successfully negotiate acceptable licenses
or other collaborative arrangements that will allow us to access
such technologies. If we cannot obtain and maintain license
rights on acceptable terms to access necessary technologies, we
may be prevented from developing some product candidates. In
addition, any technologies accessed through such licenses or
other collaborations may not help us achieve our product
development goals.
We may not be able to commercialize our products under
development if they infringe claims in existing patents or
patents that have not yet issued, and this would materially harm
our ability to operate.
As is typical in the biotechnology industry, our commercial
success will depend in part on our ability to avoid infringing
patents issued to others or breaching the technology licenses
upon which we might base our vaccines or other products. We are
aware of patents issued to others that contain claims that may
cover certain aspects of our or our collaborators
technologies, including cancer vaccine epitopes, HIV vaccine
epitopes, and methods for delivering DNA vaccines to patients.
We do not believe that any of these known patents are likely to
require us to obtain a license in order to pursue the
development or commercialization of our vaccine product
candidates. However, we may be required to take a license under
one or more of these patents to practice certain aspects of our
vaccine technologies in the United States, and such a license
may not be available on commercially reasonable terms, if at
all. If we fail to obtain a license on acceptable terms to any
technology that we need in order to develop or commercialize our
vaccines or other products, or to develop an alternative vaccine
or other product that does not infringe on the patent rights of
others, we would be prevented from commercializing our vaccine,
and our business would be harmed.
If we, or our collaborators cannot cost-effectively
manufacture vaccines in commercial quantities and for clinical
trials in compliance with regulatory requirements, we, or our
collaborators may not be able to successfully commercialize the
products.
We have not commercialized any products, and we do not have the
experience, resources or facilities to manufacture vaccines on a
commercial scale. We will not be able to commercialize any
vaccines and earn product revenues unless we, or our
collaborators, demonstrate that we can manufacture commercial
quantities of vaccines in accordance with regulatory
requirements. Among the other requirements for regulatory
approval is the requirement that prospective manufacturers
conform to the FDAs Good Manufacturing Practices, or GMP,
requirements specifically for biological drugs, as well as for
other drugs. In complying with the FDAs GMP requirements,
manufacturers must continue to expend time, money and effort in
production, record keeping and quality control to assure that
the product meets applicable specifications and other
requirements.
We currently rely and intend to continue to rely on third-party
contract manufacturers to produce materials needed for clinical
trials and, ultimately, for product commercialization.
Third-party manufacturers
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may not be able to meet our needs with respect to timing,
quantity or quality. If we are unable to contract for a
sufficient supply of needed materials on acceptable terms, or if
we encounter delays or difficulties in our relationships with
manufacturers, it may delay clinical trials, regulatory
approvals and marketing efforts for our vaccines. Such delays
could adversely affect our ability to earn revenues and our
chances of achieving profitability. We cannot be sure that we
can manufacture, either on our own our through contracts with
outside parties, vaccines at a cost or in quantities that are
commercially viable.
If we do not successfully develop and commercialize our
products, we may never generate significant revenues or become
profitable.
We have not completed the development of any product and,
accordingly, have not begun to market or generate revenues from
the commercialization of any product. We do not expect to market
any of our therapeutic or prophylactic vaccines or any other
products for at least six years (and this would assume approval
of either our HIV or lung cancer product candidate, which may
not occur). If we do not successfully develop and commercialize
products, we will never generate revenues that would allow us to
become profitable.
The lengthy approval process and uncertainty of government
regulatory requirements may impair our ability to develop,
manufacture and sell any vaccines.
We, and our collaborators, cannot commercialize our vaccines or
other products if we do not receive FDA or state regulatory
approval to market our products. The regulatory process for new
therapeutic drug products, including the required preclinical
studies and clinical testing, is lengthy, uncertain and
expensive. We, and our collaborators, may not receive necessary
FDA clearances for any of our vaccines or other potential
products in a timely manner, or at all. Once approved, we are
subject to the continuing requirements of the FDA. Noncompliance
with initial or continuing requirements can result in, among
other things:
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fines and penalties; |
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injunctions; |
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seizure of products; |
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total or partial suspension of product marketing; |
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failure of the government to grant a new drug application; |
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withdrawal of marketing approvals; and |
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criminal prosecution. |
The length of the clinical trial process and the number of
patients the FDA will require to be enrolled in clinical trials
in order to establish the safety and efficacy of our products is
uncertain. In addition, our clinical studies may not provide the
FDA with sufficient clinical data to permit approval of a new
drug application, or NDA, or a biologic license application, or
BLA, even though we, or our collaborators, believe we are doing
the right studies based on the protocol. The FDA or we and our
collaborators may decide to discontinue or suspend clinical
trials at any time if the subjects or patients who are
participating in such trials are being exposed to unacceptable
health risks or if the results show no or limited benefit in
patients treated with the vaccine compared to patients in the
control group.
Regulatory requirements are evolving and uncertain. Future
United States or state legislative or administrative acts could
also prevent or delay regulatory approval of our products. Even
if we obtain commercial regulatory approvals, the approvals may
significantly limit the indicated uses for which we may market
our products.
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The approval process outside the United States is also
uncertain and may limit our ability to develop, manufacture and
sell our products internationally.
To market any drug products outside of the United States, we and
our collaborators are also subject to numerous and varying
foreign regulatory requirements, implemented by foreign health
authorities, governing the design and conduct of human clinical
trials and marketing approval for vaccines or other drug
products. The approval procedure varies among countries and can
involve additional testing, and the time required to obtain
approval may differ from that required to obtain FDA approval.
The foreign regulatory approval process includes all of the
risks associated with obtaining FDA approval set forth above,
and approval by the FDA does not ensure approval by the health
authorities of any other country, nor does the approval by
foreign health authorities ensure approval by the FDA.
Even if we obtain regulatory approval, we may be required to
perform additional clinical trials or change the labeling of our
products if we, or others identify side effects after our
products are on the market, which could harm sales of the
affected products.
If we, or others identify adverse side effects after any of our
vaccines or other drug products are on the market, or if
manufacturing problems occur:
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regulatory approval may be withdrawn; |
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reformulation of our products, additional clinical trials,
changes in labeling of our products or changes to or
re-approvals of our manufacturing facilities may be required; |
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sales of the affected products may drop significantly; |
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our reputation in the marketplace may suffer; and |
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lawsuits, including costly and lengthy class action suits, may
be brought against us. |
Any of the above occurrences could halt or reduce sales of the
affected vaccines or other products or could increase the costs
and expenses of commercializing and marketing these vaccines or
other products.
If we are unable to protect our trade secrets, we may be
unable to protect from competitors our interests in proprietary
know-how that is not patentable or for which we have elected not
to seek patent protection.
Our competitive position depends in part on our ability to
protect trade secrets that are not patentable or for which we
have elected not to seek patent protection. To protect our trade
secrets, we rely primarily on confidentiality agreements with
our collaborative partners, employees and consultants.
Nevertheless, our collaborative partners, employees and
consultants may breach these agreements and we may be unable to
enforce these agreements. In addition, other companies may
develop similar or alternative technologies, methods or products
or duplicate our technologies, methods or vaccines that are not
protected by our patents or otherwise obtain and use information
that we regard as proprietary, and we may not have adequate
remedies in such event. Any material leak of our confidential
information into the public domain or to third parties could
harm our competitive position.
If we lose our key scientific and management personnel or are
unable to attract and retain qualified personnel, it could delay
or hurt our epitope identification and vaccine development
efforts.
We are highly dependent on the principal members of our
scientific and management staff. We do not maintain key person
life insurance on the life of any employee and, although we have
an employment contract with Dr. Emile Loria, he may
terminate his employment at any time. Our ability to identify
epitopes, develop vaccines and achieve our other business
objectives also will depend in part on the continued service of
our key scientific and management personnel and our ability to
identify, hire and retain additional qualified personnel. There
is intense competition for qualified personnel in biochemistry,
molecular biology, immunology and other areas of our activities,
and we may not be able to continue to attract and retain such
personnel necessary for the development of our business. Because
of the intense competition for qualified personnel among
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technology-based businesses, particularly in the San Diego
area, we may not be successful in adding technical personnel as
needed to meet the staffing requirements of additional
collaborative relationships. Our failure to attract and retain
key personnel could delay or be significantly detrimental to our
product development programs and could cause our stock price to
decline.
We out-license technology outside of our core area of focus,
and these licensees may not develop any products using our
technology, which may limit our revenue.
We have licensed to third parties some of our technology in
markets that we are not pursuing ourselves or with our
collaborators. If these licensees are not successful in
developing and commercializing products using our technology,
our revenues would be limited. Our licensees may pursue
alternative technologies or develop alternative products either
on their own or in collaboration with others in competition with
products developed under licenses or collaborations with us.
Some of our programs are funded by the U.S. government
and, therefore, the government may have rights to certain of our
technology and could require us to grant licenses of our
technology to third parties.
We fund certain of our research and development related to our
HIV, cancer and malaria programs pursuant to grants from the
U.S. government. As a result of these grants, the
government may have rights in the technology and inventions
developed with government funding. In addition, the government
may require us to grant to a third party an exclusive license to
any inventions resulting from the grant if the government
determines that we have not taken adequate steps to
commercialize inventions, or for public health or safety needs.
Adverse determinations concerning product pricing,
reimbursement and related matters could prevent us from
successfully commercializing products and impair our ability to
generate revenues.
Our ability to successfully commercialize our vaccines or other
products may depend in part on the extent to which reimbursement
for the cost of such products and related treatment will be
available from government health administration authorities,
private health insurers and other organizations. Third-party
payors are increasingly challenging the price of medical
products and services. Significant uncertainty exists as to the
reimbursement status of newly approved health care products, and
adequate third-party coverage may not be available to enable us
to maintain price levels sufficient to realize an appropriate
return on our investment in product development.
Product liability risks may expose us to significant
liability that could cause us to incur significant costs or
cease developing our products.
Our business exposes us to potential product liability risks
that are inherent in the testing, manufacturing and marketing of
human therapeutic products. While we currently have product
liability insurance for an early stage clinical trial, we cannot
be sure that we can maintain such insurance on acceptable terms
or obtain acceptable insurance as we progress through product
development and commercialization, or that our insurance will
provide adequate coverage against potential liabilities, either
in human clinical trials or following commercialization of any
vaccines we may develop.
Our use of hazardous materials could expose us to significant
costs.
Our research and development processes involve the controlled
storage, use and disposal of hazardous materials, chemicals and
radioactive compounds. We are subject to federal, state and
local laws and regulations governing the use, manufacture,
storage, handling and disposal of these materials and some waste
products. The risk of accidental contamination or injury from
these materials cannot be completely eliminated. In the event of
an accident, we could be held liable for any damages that
result, and any liability could exceed our resources. We cannot
be sure that compliance with environmental laws and regulations
in the future will not entail significant costs, or that our
ability to conduct research and development activities will not
be harmed by current or future environmental laws or regulations.
25
The subordination of our common stock to our preferred stock
could hurt common stockholders and, upon conversion, our
preferred stock will further dilute our holders of common
stock.
Our common stock is expressly subordinate to our series S
and series S-1 preferred stock in the event of our
liquidation, dissolution or winding up. With respect to our
series S preferred, any merger or sale of substantially all
of our assets shall be considered a deemed liquidation. If we
were to cease operations and liquidate our assets, we would
first be required to pay $10 million to our holders of
preferred stock and there may not be any remaining value
available for distribution to the holders of common stock after
providing for the series S and series S-1 preferred
stock liquidation preference. In addition, due to adjustments to
the conversion price of our series S preferred stock, in
the event our series S preferred stock is converted to
common stock, it will further dilute our holders of common stock.
The volatility of the price of our common stock may hurt our
stockholders.
The market prices for securities of biotechnology companies,
including our common stock, have historically been highly
volatile, and the market from time to time has experienced
significant price and volume fluctuations that are not
necessarily related to the operating performance of such
companies. From January 1, 2004 through February 28,
2005, our closing stock price has ranged from $1.160 to $2.660
and has been and will continue to be influenced by general
market and industry conditions. In addition, the following
factors may have a significant effect on the market price of our
common stock:
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whether we are able to secure additional financing on favorable
terms, or at all; |
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announcements of technological innovations or new commercial
vaccines or other therapeutic products by us or others; |
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governmental regulation that affects the biotechnology and
pharmaceutical industries; |
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developments in patent or other proprietary rights; |
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receipt of funding under collaboration and license agreements
and government grants; |
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developments in, or termination of, our relationships with our
collaborators and licensees; |
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public concern as to the clinical results and/or the safety of
drugs developed by us or others; and |
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announcements related to the sale of our stock. |
Fluctuations in our financial performance from period to period
also may have a significant impact on the market price of our
common stock.
Concentration of ownership among our existing officers,
directors and principal stockholders may prevent other
stockholders from influencing significant corporate decisions
and depress our stock price.
As of December 31, 2004, our officers, directors and those
stockholders owning at least five percent of our outstanding
stock together control approximately 34.1% of our outstanding
common stock as converted and Pfizer, Inc., through G.D. Searle
LLC, holds 100% of our preferred stock. If some or all of these
officers, directors and principal stockholders act together,
they will be able to exert a significant degree of influence
over our management and affairs and over matters requiring
stockholder approval, including the election of directors and
approval or disapproval of any proposed merger or financing or
other business combination transaction. The interests of this
concentration of ownership may not always coincide with our
interests or the interests of other stockholders. For instance,
officers, directors and principal stockholders, acting together,
could cause us to enter into transactions or agreements that we
would not otherwise consider. Similarly, this concentration of
ownership may have the effect of delaying or preventing a change
in control of our company otherwise favored by our other
stockholders. This concentration of ownership also could depress
our stock price.
26
We lease a 24,000 square foot administrative and research
laboratory facility in San Diego under an operating lease
that expires in March 2009. We believe our existing facilities
will be adequate to meet our needs for the foreseeable future.
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Item 3. |
Legal Proceedings |
We are not a party to any legal proceedings.
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Item 4. |
Submission of Matters to a Vote of Security Holders |
Not applicable.
PART II
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Item 5. |
Market for Registrants Common Equity and Related
Stockholder Matters |
Our common stock (Nasdaq symbol EPMN) is traded
publicly through the National Market System. The following table
presents quarterly information on the price range of our common
stock. This information indicates the high and low sale prices
reported by the National Market System. These prices do not
include retail markups, markdowns or commissions.
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High | |
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Low | |
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2005
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First Quarter (through March 29)
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$ |
1.73 |
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$ |
1.04 |
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2004
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First Quarter
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$ |
2.99 |
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$ |
1.76 |
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Second Quarter
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$ |
2.47 |
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$ |
1.60 |
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Third Quarter
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$ |
1.94 |
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$ |
1.10 |
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Fourth Quarter
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$ |
1.99 |
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$ |
1.15 |
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2003
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First Quarter
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$ |
1.25 |
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$ |
0.75 |
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Second Quarter
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$ |
2.07 |
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$ |
0.76 |
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Third Quarter
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$ |
4.29 |
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$ |
1.01 |
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Fourth Quarter
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$ |
3.21 |
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$ |
1.50 |
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As of March 29, 2005, there were approximately 260
stockholders of record of our common stock. We have never
declared or paid dividends on our common stock and do not
anticipate the payment of dividends in the foreseeable future.
For information concerning prior stockholder approval of and
other matters relating to our equity incentive plans, see
Equity Compensation Plan Information under
Item 12 in this Annual Report on Form 10-K.
During the period covered by this Annual Report on
Form 10-K, we sold and issued the following securities,
which were not registered under the Securities Act of 1933, as
amended, or the Securities Act:
(1) In April 2004, pursuant to the terms of a unit purchase
agreement, we issued 2,466,379 shares of common stock and
warrants to purchase up to 1,233,188 shares of common stock
to a group of thirteen accredited investors, including current
shareholders. The purchase price of each unit, which was the
combination of one share of common stock and 50% of a warrant,
was $2.2125 for gross proceeds to us for the transaction of
$5.5 million. Our sale of the common stock and warrants was
exempt from registration requirements under the Securities Act
pursuant to Rule 506 thereof because each of the purchasers
of securities was an accredited investor.
27
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Item 6. |
Selected Financial Data |
Please read the following selected financial data in conjunction
with Managements Discussion and Analysis of
Financial Condition and Results of Operations and the
Consolidated Financial Statements and related notes included
elsewhere in this annual report on Form 10-K.
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Years Ended December 31, | |
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2004 | |
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2003 | |
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2002 | |
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2001 | |
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2000 | |
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(In millions, except for net loss per share) | |
Operating revenues
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$ |
9.6 |
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$ |
7.2 |
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$ |
7.1 |
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$ |
8.2 |
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$ |
1.6 |
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Net loss
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(3.9 |
) |
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(7.1 |
) |
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(6.5 |
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(2.6 |
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(4.7 |
) |
Net loss per share basic and diluted
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(0.25 |
) |
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(0.58 |
) |
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(0.57 |
) |
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(0.31 |
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(0.68 |
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As of December 31, | |
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Balance Sheet Data: |
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2004 | |
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2003 | |
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2002 | |
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2001 | |
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2000 | |
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(In millions) | |
Working capital
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$ |
6.4 |
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$ |
4.8 |
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$ |
7.7 |
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$ |
15.4 |
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$ |
8.2 |
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Total assets
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14.8 |
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12.7 |
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15.5 |
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23.9 |
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14.5 |
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Long-term obligations
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0.04 |
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0.4 |
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Stockholders equity
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11.1 |
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9.7 |
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12.6 |
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19.4 |
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12.1 |
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Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
Except for the historical information contained herein, the
following discussion contains forward-looking statements that
involve risks and uncertainties. Our actual results could differ
materially from those discussed here. Factors that could cause
or contribute to such differences include, without limitation,
those discussed below and in the section entitled Risk
Factors.
Since 1997, we have devoted substantially all of our resources
to the discovery and development of potential therapeutic and
prophylactic products. To date, we have not received any
revenues from the sale of products. We have funded our research
and development primarily from equity-derived working capital,
through strategic alliances and collaborations with other
companies and through government research funding, primarily
from the National Institutes of Health in the form of grants and
contracts. We have not been profitable since our inception and
expect to incur substantial operating losses for at least the
next several years. As of December 31, 2004, our
accumulated deficit was approximately $161.8 million.
In July 2001, we entered into a collaboration with Genencor for
vaccines to treat or prevent hepatitis B virus, hepatitis C
virus and human papilloma virus. Pursuant to the agreement, we
exclusively licensed to Genencor our PADRE® and epitope
technologies for vaccines to treat or prevent hepatitis B,
hepatitis C and human papilloma virus. In connection with
this collaboration, we received an upfront license fee, which
was amortized over the collaboration term. In addition, Genencor
made an initial ten percent equity investment in Epimmune common
stock at a premium to the market price. The agreement provided
for us to receive up to a total of approximately
$60 million in payments, including the initial equity
investment but excluding royalties. In January 2002, we received
a payment from Genencor for achievement of the first milestone,
identification of a product candidate to treat chronic hepatitis
B infection. In February 2004, we announced we had earned a
milestone payment from Genencor as a result of Genencor filing
an IND for a vaccine to treat hepatitis B. The milestone
payments were recognized as revenue when received. The
collaboration revenues were recognized as incurred. In addition,
Genencor fully funded Epimmunes research in these specific
indications and was obligated to pay us royalties on sales of
any products that may have been developed under the
collaboration. All revenues from Genencor have been included in
related party revenue. The initial collaboration had a term
through September 2003, and in October 2002, was extended to
September 2004. In March 2004, Genencor assigned its rights
under the collaboration and license agreements to Innogenetics
NV, which does not own an equity position in Epimmune and is not
a related party. In connection with the assignment to
Innogenetics, we extended the collaboration term with
Innogenetics through September 2005 and are now amortizing the
remaining unamortized portion of the license fee over this
extended term. In addition, Genencor agreed not to
28
sell or otherwise dispose of any of the Epimmune common stock it
held, without our prior approval, for a minimum of twelve
months. Innogenetics has the right to terminate the
collaboration early, upon three months written notice, if
Epimmune breaches its obligations under the collaboration
agreement or upon certain force majeure events.
In September 2003, we announced a reduction of our work force
aimed at focusing our efforts on our most advanced clinical
programs and our sponsored and partnered programs. We reduced
our research and administrative staff by 11 individuals or 23%,
which resulted in a one-time restructuring charge of
approximately $336,000 in the third quarter of 2003.
In September 2003, Dr. Loria, our President and CEO
surrendered an aggregate of 963,740 shares of our common
stock, including 250,139 unvested shares, at the fair market
value of $3.17 per share, in exchange for the prepayment of
the outstanding principal and interest under a promissory note
issued by Dr. Loria in January 2001 for the purchase of
1,056,301 shares of our common stock at a purchase price of
$2.50 per share. The aggregate value of the shares
surrendered was $3,055,000. The remaining 92,561 unvested shares
vested in equal daily installments between September 29,
2003 and January 15, 2005. In connection with this
transaction, we recorded a non-cash, stock-based compensation
charge of approximately $645,000 in the third quarter of 2003
based on the difference between the fair market price on
September 29, 2003 and the exercise price of the shares
surrendered by Dr. Loria. We also recognized an additional
$62,000 in non-cash, stock-based compensation charges ratably
over the period from September 29, 2003 to January 15,
2005 as the remaining 92,561 unvested shares vested.
In September 2003, we completed a private placement of
2,168,961 shares of common stock and warrants to purchase
up to 542,238 shares of common stock to selected
institutional and accredited investors, including current
shareholders, for a total purchase price of $4.05 million.
We received net proceeds of $3.6 million. The purchase
price of each security, which is the combination of one share of
common stock and a warrant to purchase 25% of one share of
common stock, was priced at the market value of $1.86725, which
was the sum of the average of the closing bid price of Epimmune
common stock as quoted on the Nasdaq National Market for the
five days up to and including September 17, 2003, and
$0.03125, the imputed value of a warrant to purchase 25% of
one share of common stock. In addition, we issued warrants to
purchase an aggregate of 250,000 shares of our common stock
to a placement agent for services rendered in connection with
the private placement. Each warrant, including the warrant
issued to the placement agent, has a three-year term and an
exercise price equal to 125% of $1.86725 or $2.33406 per
share. We filed a registration statement to permit registered
resales of the common stock and the common stock issuable upon
exercise of the warrants sold in the transaction. The
registration statement was declared effective on
October 21, 2003.
In April 2004, we completed a private placement of
2,466,379 shares of common stock and warrants to purchase
up to 1,233,188 shares of common stock to selected
institutional and accredited investors, including current
shareholders, for a total purchase price of $5.5 million.
We received net proceeds of $5.0 million. The purchase
price of each security, which is the combination of one share of
common stock and, for each two shares of common stock purchased,
a warrant to purchase one share of common stock, was priced at
the market value of $2.2125, which was equal to or greater than
the sum of the closing bid price of our common stock as quoted
on the Nasdaq National Market on the date of execution of the
purchase agreements, and $0.0625, the imputed value of a warrant
to purchase one share of common stock. In addition, we issued
warrants to purchase an aggregate of 250,000 shares of our
common stock to a placement agent for services rendered in
connection with the private placement. Each warrant, including
the warrant issued to the placement agent, has a three-year term
and an exercise price equal to 120% of $2.2125 or
$2.655 per share. We filed a registration statement to
permit registered resales of the common stock and the common
stock issuable upon exercise of the warrants sold in the
transaction. The registration statement was declared effective
on May 6, 2004.
Subsequent Events
On March 16, 2005, we announced that we had agreed to
combine our business with IDM, a privately held company based in
France, pursuant to a Share Exchange Agreement. The all-stock
transaction has been
29
unanimously approved by the boards of directors of both
companies. In addition, certain institutional investors,
strategic partners and executives of IDM who collectively hold
more than 85% of IDMs outstanding stock (including shares
issuable upon exercise of warrants) have entered into the Share
Exchange Agreement thus far. The closing of the transaction is
subject to certain closing conditions including approval by our
shareholders. Upon closing of the transaction, the combined
company will be named IDM, Inc. and its shares are expected to
trade on the Nasdaq National Market under the ticker IDMI. The
combined company will focus on immunotherapeutic products for
cancer and selected infectious diseases.
Pursuant to the Share Exchange Agreement, we will acquire all of
the outstanding share capital of IDM, with certain exceptions
related to shares and a warrant held in French share savings
plans, in exchange for shares of our common stock, and IDM will
become our subsidiary. Each share of IDM will be exchanged for
approximately 3.771865 shares of our common stock, and the
former shareholders of IDM will hold, in the aggregate,
approximately 78% of our common stock, on a fully diluted basis,
immediately following the closing of the transaction. In
connection with the transaction, our outstanding Series S
and Series S-1 preferred stock will be exchanged for a
total of 1,949,278 shares of our common stock. The Share
Exchange Agreement also sets forth the terms for treatment of
outstanding options and warrants to purchase IDM shares in
the transaction.
Subsequent to the transaction, IDM will effectively control us.
As a result, the transaction will be accounted for as a reverse
acquisition, whereby for financial reporting purposes, IDM is
considered the acquiring company. Hence, the historical
financial statements of IDM will become our historical financial
statements and will include our results of operations only from
the acquisition date forward.
The shares we will issue in the exchange will not be registered
under U.S. securities laws and may not be offered or sold
in the U.S. absent registration or unless an applicable
exemption from the registration requirements is available. We
will file a registration statement covering the resale of the
shares issued in the transaction following the closing of the
transaction.
We will issue common stock equal to more than 20% of our
outstanding voting shares pursuant to the Share Exchange
Agreement and will therefore have to obtain shareholder approval
of the transaction in accordance with Nasdaq rules. We will file
a proxy statement and hold a meeting of our shareholders to
approve the Share Exchange Agreement and certain related actions
including changing our name to IDM, Inc.
The combined company will be headquartered in San Diego
following the closing of the transaction, and will have
manufacturing sites in Irvine, California and Paris, France. The
combined company will have approximately 150 employees.
Dr. Jean-Loup Romet-Lemonne, Chairman and Chief Executive
Officer of IDM will be CEO of the combined company,
Dr. Emile Loria, our President and CEO, will be President
and Chief Business Officer of the combined company and Bob De
Vaere, our Chief Financial Officer, will be Chief Financial
Officer of the combined company.
IDMs lead product candidate, MEPACT, has completed
Phase III clinical trials in the U.S. for the
treatment of osteosarcoma. MEPACT has received Orphan Drug
Status in both the U.S. and Europe, and IDM is working with U.S.
and E.U. regulatory agencies regarding the process for obtaining
product marketing approval. In addition to MEPACT, the combined
company will have a portfolio of six product candidates in
clinical development, including one product candidate in
Phase II/ III clinical trials and two product candidates in
Phase II clinical trials.
The forgoing statements regarding the proposed transaction
between us and IDM includes forward looking statements, which
are subject to risks and uncertainties, including but not
limited to the possibility that the proposed transaction with
IDM may not ultimately close for any of a number of reasons,
such as our not obtaining shareholder approval of the
transaction or related matters; failure of holders of at least
95% of the outstanding stock of IDM to become parties to the
definitive agreement; the possibility that IDM shareholders who
have not become parties to the definitive agreement make an
alternative bid regarding a transaction involving IDM to the IDM
shareholders pursuant to rights under the shareholders agreement
among the IDM shareholders and, if so, that the IDM shareholders
accept that bid instead of the transaction
30
with us; and the possibility that Nasdaq will not approve the
listing of the combined companys shares for trading on the
Nasdaq National Market; and that, in the event the transaction
is completed, the combination of us and IDM may not result in a
stronger company, that the technologies and clinical programs of
the two companies may not be compatible and that the parties may
be unable to successfully execute their integration strategies
or realize the expected benefits of the transaction.
Significant Accounting Policies
Our discussion and analysis of our financial condition and
results of operations are based upon our consolidated financial
statements, which have been prepared in accordance with
accounting principles generally accepted in the United States.
The preparation of these financial statements requires us to
make estimates and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses, and related
disclosure of contingent assets and liabilities. On an ongoing
basis, we evaluate our estimates, including those related to
revenue recognition, patents and income taxes. We base our
estimates on historical experience and on various other
assumptions that are believed to be reasonable under the
circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions or
conditions. We believe the following critical accounting
policies affect the significant judgments and estimates used in
the preparation of our consolidated financial statements (see
Note 1 to our financial statements).
We recognize revenues pursuant to Staff Accounting
Bulletin No. 104, Revenue Recognition.
Collaboration revenues are earned and recognized as research
costs are incurred in accordance with the provisions of each
agreement. License fees are earned and recognized in accordance
with the provisions of each agreement. Upfront license fees for
perpetual licenses where we have no performance obligations are
recognized when received. License fees with ongoing involvement
or performance obligations are recognized over the term of the
agreement. For example, in connection with our Genencor
collaboration, which has now been assigned to Innogenetics,
because we received an upfront license fee, it is being
amortized into revenue over the collaboration term. Fees paid to
initiate research projects are deferred and recognized over the
project period. Milestone payments are recognized as revenue
upon the completion of the milestone as long as the milestone
event was substantive, and its achievability was not reasonably
assured at inception and our performance obligations after
milestone achievement will continue to be funded at a comparable
level before the milestone achievement. Revenues from grants are
recognized on a percentage-of-completion basis as related costs
are incurred. We defer revenue recognition until performance
obligations have been completed and collectibility is reasonably
assured.
We capitalize the costs incurred to file patent applications
when we believe there is a high likelihood that the patent will
issue and there will be future economic benefit associated with
the patent. These costs are amortized over a ten-year life from
the date of patent filing. We expense all costs related to
abandoned patent applications. In addition, we review the
carrying value of patents for indicators of impairment on a
periodic basis. If we elect to abandon any of our currently
issued or unissued patents or we determine that the carrying
value is impaired, the related expense could be material to our
results of operations for the period of the abandonment.
The primary objective of our investment activities is to
preserve principal while at the same time achieving competitive
yields, without significantly increasing risk. To achieve this
objective, we primarily invest in cash and money market accounts
as well as A1 or P1 or higher rated debt securities with
maturities of less than two years, with the weighted average
maturity not to exceed eighteen months. We also attempt to
minimize our portfolio risk by placing constraints on how much
of our portfolio may be held in a specific type
31
of investment such as asset-backed securities or collateralized
mortgage obligations as well as limiting our holdings in any one
issuer. At December 31, 2004, our investment portfolio
included only cash and money market accounts and had no
fixed-income securities.
Results of Operations
We had total revenue of $9.6 million for the year ended
December 31, 2004, compared to revenue of $7.2 million
for the year ended December 31, 2003. The increase in the
year ended December 31, 2004 relates primarily to a
$5.4 million increase in research grants and contract
revenue, offset by a $2.5 million decrease in related party
revenue and a $0.4 million decrease in licensing and
milestone revenue. The increase in research grants and contract
revenue during 2004 was primarily due to reimbursement under
grants and contracts received from the NIH in late 2003 and 2004
and recognition of reimbursements under our collaboration
agreement with Innogenetics as contract revenue rather than
related party revenue following Genencors assignment of
its rights under our collaboration and license agreements to
Innogenetics in March 2004. Innogenetics does not own an equity
position in Epimmune and, therefore, is not a related party and
reimbursements under our collaboration agreement with them are
now recorded as contract revenue. The decrease in related party
revenue during the year ended December 31, 2004, compared
to the year ended December 31, 2003, was also a result of
the assignment by Genencor to Innogenetics and the corresponding
change in revenue accounts. Overall, we received
$1.2 million less in licensing, milestone and contract
revenues from the programs previously partnered with Genencor
and now partnered with Innogenetics during 2004 as compared to
2003. Two of the partnered programs have advanced to clinical
development or late stage preclinical development and did not
require the same level of support from us during 2004 as they
did in 2003. In connection with the assignment by Genencor, we
extended the collaboration term with Innogenetics through
September 2005. Innogenetics will have the right to terminate
the collaboration early, upon three months written notice. The
decrease in licensing and milestone revenue during the year
ended December 31, 2004 compared to the year ended
December 31, 2003 was a result of previously received
evaluation and license option fees being fully amortized into
revenue by the end of 2003.
We had total revenue of $7.2 million for the year ended
December 31, 2003 and $7.1 million for the year
December 31, 2002. A decrease of $1.2 million in
related party revenue from Genencor in 2003 was offset by an
increase of $0.6 million in licensing fees and milestone
revenue and a $0.6 million increase in research grant and
contract revenue during 2003. The decrease of $1.2 million
in related party revenue in the year ended December 31,
2003, compared to the year ended December 31, 2002, was
primarily due to the shift in focus of our collaboration with
Genencor from scientific research activities, the part of the
collaboration in which we were most involved, to preclinical
development on the lead program in support of a late 2003
Investigational New Drug, or IND, filing by Genencor, lower
non-recurring milestone payments received in 2003 compared to
2002, and an increase in the time period during which the
license fees previously paid by Genencor were amortized due to
the extension of the collaboration term. The change in the
estimated life of the license occurred due to the extension of
the collaboration term from September 1, 2003 to
September 1, 2004. The agreement term was extended in
October of 2002. The increase of $0.6 million in licensing
fees and milestone revenue in the year ended December 31,
2003, compared to the year ended December 31, 2002 was due
to the receipt of one-time payments for license fees and
milestones during 2003 under the terms of our agreement with
Anosys, and an increase in licensing revenue as a result of
amortization of evaluation fees and license fees received from
Aventis, IDM, Beckman Coulter, Merck and Amgen in 2003, compared
to 2002. The increase of $0.6 million in grant and contract
revenue in the year ended December 31, 2003, compared to
the year ended December 31, 2002 was due to higher
reimbursable expenses on several existing grants and contracts
during 2003 than in 2002 and reimbursement of expenses on a new
contract we received in September of 2003 from the NIH to
develop a preventive HIV vaccine.
A significant portion of our research and development expense is
related either to work performed under grants and contracts from
the NIH or to work we perform under a collaboration agreement
with Innogenetics. Under our NIH grants and contracts, we are
able to invoice the NIH each month for direct research and
development expenses we incur, such as our internal labor costs,
and for outside costs such as subcontractors working for us on a
specific program. We are also able to invoice for fringe costs
related to our labor and for
32
overhead expenses, both at prescribed rates negotiated in
advance with the government. In some instances, we are also able
to invoice a fixed fee, negotiated with the NIH in advance for a
specific program.
In the largest of our current programs, a contract with the NIH
for developing a preventative HIV vaccine with a total potential
value of $16.7 million over five years, we have been
authorized to spend, or invoice, up to $8.6 million through
September 2005, which represents the first two years of the
program. Thus far, as of December 31, 2004, we have
incurred costs of approximately $4.0 million on this
program, and have invoiced the NIH for $4.2 million.
Under our collaboration agreement with Innogenetics, our
employees record their actual time worked on the collaboration
each day and at the conclusion of each month, we determine the
number of full time equivalent employees, on an annualized
basis, who worked on the collaboration. We then invoice
Innogenetics at a negotiated, annualized rate per full time
equivalent employees who worked on the collaboration during the
month. The annualized rate at which we invoice is intended to
include the direct labor as well as fringe and overhead expenses
related to and in support of the direct labor.
A description of our research and development programs and their
status is included in Business above. We have
programs in various stages of research and development and,
given that plans for additional research and development and, if
applicable, commercialization depend upon, among other things,
the outcome of testing at each stage of research and development
and regulatory review, it is not possible for us to determine
when, if ever, these programs might be completed or the costs to
complete these programs. Risks and uncertainties associated with
our research and development programs are described in
Risk Factors above.
Research and development expenses were $10.9 million in the
year ended December 31, 2004, compared to
$10.5 million in the year ended December 31, 2003. The
increase in research and development expenses in 2004 was
primarily due to a $1.5 million increase in sponsored
research related to our subcontractors on NIH grants and
contracts and a $0.2 million increase in outside costs
related to clinical trials. This increase was partially offset
by a $0.7 million reduction in labor and associated costs
as a result of our workforce reduction in September 2003, and a
$0.4 million reduction in purchases of vaccine supplies for
clinical trials.
Research and development expenses decreased to
$10.5 million in the year ended December 31, 2003 from
$11.3 million in the year ended December 31, 2002. The
decrease in the year ended December 31, 2003 was primarily
due to lower outside costs related to preclinical activities
such as formulation and toxicology studies for our HIV and lung
and colorectal cancer product candidates which had all entered
clinical trials by 2003, lower scientific supplies costs related
to completion of preclinical activities, lower patent and
intellectual property related expenses, and reduced labor costs
related to our work force reduction, partially offset by higher
costs associated with outside research support related to our
High Throughput Screening contract with the NIH and outside
research and development support on a new contract we received
in September of 2003 from the NIH to develop a preventive HIV
vaccine.
General and administrative costs decreased to $2.7 million
in the year ended December 31, 2004, from $3.6 million
in the year ended December 31, 2003. The decrease during
2004 compared to 2003 relates primarily to higher comparative
operating expenses in 2003 which included recognition of
non-cash, stock-based compensation charges of $0.6 million
in connection with the prepayment of a promissory note by
Dr. Emile Loria, our president and chief executive officer
in September 2003, a $0.5 million write off in 2003 of
legal, investment banking, accounting and other expenses related
to our proposed merger with Anosys, which was terminated, and a
$0.2 million reduction in labor and associated costs in
2004 as a result of our work force reduction in September 2003.
This was partially offset by $0.4 million in costs in 2004
associated with our proposed combination with IDM, S.A.
General and administrative costs were approximately
$3.6 million in the year ended December 31, 2003
compared to $2.9 million in the year ended
December 31, 2002. The increase in the year ended
December 31, 2003 was due to recognition of
$0.6 million in non-cash, stock-based compensation charges
in connection with the prepayment of a promissory note by our
CEO in September 2003, other non-cash, stock-based compensation
expenses related to a higher stock price for variable stock
equity instruments, and the write off of $0.5 million in
legal, investment banking, accounting and other expenses related
to our proposed merger
33
with Anosys, which was terminated. The increases were partially
offset by a reduction in consultant fees and other outside
costs, and a reduction in travel expenses.
In September 2003, we announced a reduction of our work force
aimed at reducing our cash burn and focusing our efforts on our
most advanced clinical programs and our sponsored and partnered
programs. We reduced our research and administrative staff by 11
individuals or 23%, which resulted in a one-time restructuring
charge of approximately $336,000 in the year ended
December 31, 2003. We had no restructuring related charges
in 2004 or 2002.
Net interest income was approximately $0.1 million in 2004
compared to $0.2 million in 2003 and $0.6 million in
2002. Interest income during 2003 included approximately
$0.1 million of interest accrued on the note issued for the
purchase in January 2001 of our common stock by Dr. Loria,
our president and chief executive officer, compared to
approximately $0.3 million of interest accrued on the note
in 2002. We had lower average cash balances in the year ended
December 31, 2004, compared to the year ended
December 31, 2003. We had lower average cash balances and
rates of return in the year ended December 31, 2003,
compared to the year ended December 31, 2002.
We expect to incur operating losses over at least the next
several years due to continuing expenses associated with our
research and development programs, including clinical trials,
preclinical testing and development activities. Operating losses
may fluctuate from quarter to quarter as a result of differences
in the timing and amounts of revenues received and expenses
incurred, and such fluctuations may be substantial.
Liquidity and Capital Resources
We have financed operations since inception primarily through
private placements of our equity securities, two public common
stock offerings, license fees, revenues under collaborative
research and development agreements, grant revenues, capital and
operating lease transactions, certain asset divestitures and
interest income. Through December 2004, we have raised
approximately $170.1 million from the sale of equity
securities, of which $35.1 million was raised to fund the
business since the formation of our business related to
immunotherapy. As of December 31, 2004, we had
17,799,227 shares outstanding on an as-converted to common
stock basis, assuming conversion of the series S
and S-1 preferred shares.
As of December 31, 2004, our cash and cash equivalents were
$7.0 million compared to $6.4 million at
December 31, 2003. The increase was primarily due to a
$5.0 million private placement we completed in April 2004,
partially offset by $3.4 million of cash used to fund our
research and development and clinical activities,
$0.7 million of cash used for capitalized patent costs and
$0.2 million of cash used to purchase capital equipment.
Our operating expenses were offset by license fees, milestone
payments and grant and contract revenues we received. We expect
to continue to use our cash and cash equivalents to fund our
ongoing and future clinical trials, as well as our drug research
and development programs. We had net working capital of
$6.4 million as of December 31, 2004 compared to
$4.8 million as of December 31, 2003.
Capital expenditures for the year ended December 31, 2004
were $0.2 million compared to $0.1 million for the
year ended December 31, 2003 and $0.7 million for the
year ended December 31, 2002. The expenditure for 2004 was
primarily for the purchase of equipment to support our ongoing
clinical trials. The expenditures for 2003 were primarily for
small laboratory equipment. The expenditures for 2002 were
primarily for laboratory equipment to increase and improve
immunological screening throughput, to build out additional
laboratory space to accommodate additional employees and for
information technology equipment and upgrades to accommodate new
employees. In the past, we have financed our laboratory
equipment and research and office facilities primarily through
operating lease arrangements and a note payable. We did not have
any outstanding notes payable in 2004. During 2003, we made
payments of $0.04 million and fully paid off our
outstanding note payable. During 2002, we made payments of
$0.3 million under the notes payable. During 2005, we
anticipate that payments related to capital expenditures will
decrease compared to 2004 levels to approximately
$0.1 million. We will also pay approximately
$0.6 million in rent on our lease commitments during 2005.
The future minimum rental commitment for the lease of our
facility will range from approximately $0.6 million to
$0.7 million each year over five years, based upon
pre-established annual rent increases.
34
Payments related to capitalized patent expenses were
approximately $0.7 million, $0.8 million and
$1.2 million for 2004, 2003 and 2002, respectively. The
decrease in 2004 compared to 2003 reflects continuation of our
efforts to consolidate our intellectual property portfolio and
control our outside legal expenses. The decrease in 2003
compared to 2002 was due primarily to consolidation of our
patent portfolio with one outside law firm to limit
administrative redundancies as well as bringing certain
administrative tasks in house to limit outside legal expenses.
We expect payments related to patents to be relatively flat in
2005 compared to 2004.
As funds are available, we expect our net cash burn to increase
in 2005 compared to 2004 levels as a result of costs related to
ongoing clinical trials in connection with our ongoing drug
research and development programs, research and development
activities on sponsored programs and contracts, preclinical
testing of product candidates and manufacturing of clinical
supplies. We intend to seek collaborative research and
development relationships with suitable corporate partners and
U.S. government agencies. We have in the past and may in
the future also license to third parties some of our technology
in markets that we are not pursuing ourselves or through our
collaborations. Any agreements that may result from these
discussions may not successfully reduce our funding requirements
or, if entered into, may be terminated.
We will continue to spend substantial amounts on research and
development, including amounts spent for manufacturing clinical
supplies, conducting clinical trials for our product candidates
and advancing development of certain sponsored and partnered
programs. Therefore, we will need to secure additional funding,
in addition to the approximately $5.5 million we raised in
April 2004. We do not have committed external sources of funding
and may not be able to obtain any additional funding, especially
if volatile market conditions persist for biotechnology
companies. If we are unable to obtain additional funding, we
will be required to delay, further reduce the scope of or
eliminate one or more of our research and development projects,
sell the Company or certain of its assets or technologies, or
dissolve and liquidate all of its assets. As of
December 31, 2004, we had approximately $7.0 million
in cash and cash equivalents. We have incurred and will continue
to incur legal, accounting and other transaction costs in
connection with our proposed combination with IDM. If we do not
complete the proposed combination as planned, our cash position
will be further reduced, and it will likely be even more
difficult to raise additional funding on satisfactory terms, if
at all. Our future operational and capital requirements will
depend on many factors, including:
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|
|
|
|
whether our proposed transaction with IDM is successfully
completed; |
|
|
|
whether we are able to secure additional financing on favorable
terms, or at all; |
|
|
|
the costs associated with our ongoing Phase I/ II clinical
trial for our vaccine targeting HIV, which began in September
2002, including the status of our contract with the NIH; |
|
|
|
the costs associated with our Phase II clinical trial for
our vaccine targeting lung cancer, which began in December 2004; |
|
|
|
progress with other preclinical testing and clinical trials in
the future; |
|
|
|
our ability to establish and maintain collaboration and license
agreements and any government contracts and grants; |
|
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|
the actual revenue we receive under our collaboration and
license agreements; |
|
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|
the actual costs we incur under our research collaboration with
Bavarian Nordic; |
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the time and costs involved in obtaining regulatory approvals; |
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|
the costs involved in filing, prosecuting, enforcing and
defending patent claims and any other proprietary rights; |
|
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competing technological and market developments; |
|
|
|
changes in our existing research relationships; |
35
|
|
|
|
|
continued scientific progress in our drug discovery
programs; and |
|
|
|
the magnitude of our drug discovery and development programs. |
As is typical in the biotechnology industry, our commercial
success will depend in part on not infringing upon the patent or
other proprietary rights of others and maintaining the
technology licenses upon which our products might be based. Our
business is also subject to other significant risks, including
the uncertainties associated with our ability to enter into and
maintain new collaborations, the lengthy regulatory approval
process, and potential competition from other products. Even if
our products appear promising at an early stage of development,
they may not reach the market for a number of reasons. Such
reasons include, but are not limited to, our inability to fund
clinical development of such products, or the possibilities that
the potential products will be found ineffective during clinical
trials, fail to receive necessary regulatory approvals, be
difficult to manufacture on a large scale or be uneconomical to
market.
Contractual Obligations
The following table summarizes our contractual obligations at
December 31, 2004, and the effect such obligations are
expected to have on our liquidity and cash flows in future
periods.
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|
|
|
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|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
|
|
Less than | |
|
Years | |
|
Years | |
|
More than | |
|
|
Total | |
|
1 Year | |
|
2-3 | |
|
4-5 | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Unaudited) | |
|
|
(in thousands) | |
Operating lease obligations(1)
|
|
|
2,685 |
|
|
|
602 |
|
|
|
1,259 |
|
|
|
824 |
|
|
|
|
|
Licensing and purchase obligations(2)(3)
|
|
|
1,921 |
|
|
|
419 |
|
|
|
412 |
|
|
|
390 |
|
|
|
700 |
|
Deferred compensation
|
|
|
184 |
|
|
|
63 |
|
|
|
121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
4,790 |
|
|
$ |
1,084 |
|
|
$ |
1,792 |
|
|
$ |
1,214 |
|
|
$ |
700 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
(1) |
Facilities lease, which expires in March 2009. |
|
(2) |
Licensing and purchase obligations includes an estimate of
$1,560,000 for future payment obligations under existing license
agreements which may become due and payable in the periods
specified based on projected achievement of triggering events,
although there can be no assurance such events will be achieved
in the projected time frames, if at all. |
|
(3) |
Projections do not include obligations under any of our
agreements related to the conduct of clinical trials as these
agreements may generally be terminated with 30-days notice. |
Recently Issued Accounting Standards
As permitted by the Financial Accounting Standards Board
Statement No. 123, Accounting for Stock-Based
Compensation, we currently account for share-based
payments to employees using the Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to
Employees, the intrinsic value method and, as such,
generally recognize no compensation cost for employee stock
options. Accordingly, the adoption of
Statement 123®s fair value method will have a
significant impact on our result of operations, although it will
have no impact on our overall financial position. The impact of
adoption of Statement 123® cannot be predicted at this
time because it will depend on levels of share-based payments
granted in the future. However, had we adopted
Statement 123® in prior periods, the impact of that
standard would have approximated the impact of
Statement 123 as described in the disclosure of pro forma
net income and earnings per share included in Note 1 to the
consolidated financial statements
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Item 7A. |
Quantitative and Qualitative Disclosures About Market
Risks |
At December 31, 2004, our investment portfolio included
only cash and money market accounts and had no fixed-income
securities. There would be no material impact to our investment
portfolio, in the short term,
36
associated with any change in interest rates and any decline in
interest rates over time will reduce our interest income, while
increases in interest rates over time will increase our interest
income.
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Item 8. |
Consolidated Financial Statements and Supplementary
Data |
The financial statements and supplemental data required by this
item are set forth at the pages indicated in Item 15(a)(1)
of this annual report.
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|
Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
None.
Item 9(A). Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our
management, including our principal executive officer and
principal financial officer, we conducted an evaluation of the
effectiveness of the design and operation of our disclosure
controls and procedures, as such term is defined under
Rule 13a-14(c) promulgated under the Securities Exchange
Act of 1934, as amended, within 90 days prior to the filing
date of this report. Based on their evaluation, our principal
executive officer and principal financial officer concluded that
our disclosure controls and procedures are effective as of the
end of the period covered by this report.
(b) Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over
financial reporting during the fourth quarter ended
December 31, 2004 that has materially affected, or is
reasonably likely to materially affect, our internal control
over financial reporting.
PART III
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Item 10. |
Directors and Executive Officers of the Registrant |
The following table sets forth information regarding our current
directors and executive officers as of February 15, 2005:
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Name |
|
Age | |
|
Position |
|
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| |
|
|
Directors:
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Howard E. (Ted) Greene, Jr.
|
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62 |
|
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Chairman of the Board of Directors |
William T. Comer, Ph.D.
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|
|
69 |
|
|
Director |
Georges Hibon
|
|
|
67 |
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Director |
Michael G. Grey
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52 |
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Director |
Emile Loria, M.D.
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55 |
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Director, President and Chief Executive Officer |
John P. McKearn, Ph.D.
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51 |
|
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Director |
Executive Officers:
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Emile Loria, M.D.
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55 |
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Director, President and Chief Executive Officer |
Robert J. De Vaere
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|
47 |
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Vice President, Finance and Administration, and Chief Financial
Officer |
Mark J. Newman, Ph.D.
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50 |
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Vice President, Research and Development |
Mr. Greene, a founder of Epimmune, has served
as a director since our inception. He was elected Chairman of
the Board in January 1989 and served as President from July 1987
to January 1989. Mr. Greene is a director and founder of
Amylin Pharmaceuticals, Inc., a biotechnology company involved
in research and
37
development of medicines for treating diabetes and served as
Chairman of the Board from 1987 to 1998. He was a general
partner of Biovest Partners, a seed venture capital firm
specializing in medical technology companies from 1986 until
1993. Prior to Biovest, he was Chief Executive Officer of
Hybritech Incorporated, a biotechnology company acquired by Eli
Lilly & Company in 1986. Mr. Greene is a director
of Amylin and Biosite Incorporated.
Dr. Comer has served as a director since
January 1994. Since April 2000, he has been a director of
TorreyPines Therapeutics, Inc., a privately held
biopharmaceutical company, where he also served as Chairman of
the Board from May 2000 through December 2004 and as Interim
Chief Executive Officer from March 2000 through March 2002.
Dr. Comer served as President and Chief Executive Officer
and a member of the Board of Directors of SIBIA Neurosciences,
Inc., a biotechnology company, from April 1991 to November 1999.
SIBIA was acquired by Merck & Co., Inc. in November
1999. Dr. Comer resigned in November 1999, but continued to
serve as a consultant to Merck from December 1999 until August
2000. Dr. Comer previously served in various roles with
Bristol-Myers Squibb, a pharmaceutical company, culminating in
his position as Senior Vice President of Strategic Management,
Pharmaceuticals and Nutritionals. He served as Chairman of
Prescient Neuropharma, Inc. until December 17, 2002 and is
currently a director of Innapharma, Inc.
Mr. Hibon has served as a director since
August 2001. He currently serves as an advisor and has served
since 1998 to several companies and organizations in Europe and
North America. From 1990 to 1998, he was with Pasteur Merieux
Connaught, now Aventis Pasteur, a pharmaceutical company, most
recently as Chairman and Chief Executive Officer of PMC North
America, a vaccine focused business. From 1986 to 1989, he was
with Gillette group as President Director General of ST Dupont,
a luxury goods distributor. He was with Merck & Co., a
pharmaceutical company, from 1968 to 1986 during which time he
held various executive positions in their European and
international operations. He currently serves on the Boards of
Directors of Cerep, Aphton Corporation and Care France.
Mr. Grey has served as our director since
July 1999. Since January 1, 2005, he has served as
President and Chief Executive Officer of Structural GenomiX,
Inc., a privately held biotechnology company, where he
previously served as President from June 2003 to January 1,
2005 and as Chief Business Officer from April 1, 2001 until
June 2003. In addition, Mr. Grey has been a member of the
Board of Directors of Structural GenomiX since September 2001.
Between January 1999 and September 2001, he served as President
and Chief Executive Officer of Trega Biosciences, Inc., a
biotechnology company. Prior to joining Trega, Mr. Grey
served as President of BioChem Therapeutics, Inc., a division of
BioChem Pharma, Inc., a pharmaceutical company, from November
1994 to August 1998. During 1994, Mr. Grey served as
President and Chief Operating Officer of Ansan, Inc., a
biopharmaceutical Company. From 1974 to 1993, Mr. Grey
served in various roles with Glaxo, Inc. and Glaxo Holdings,
plc, a pharmaceutical company, culminating in his position as
Vice President, Corporate Development. Mr. Grey serves on
the Board of Directors of Achillion Pharmaceuticals, Inc.
Dr. Loria has served as our director since
January 2001. He joined us as President and Chief Executive
Officer in June 2001. From 1995 to 2000, he served as President
and Chief Executive Officer of Biovector Therapeutics, a vaccine
company. Prior to his appointment as Chief Executive Officer, he
served as Senior Vice President, Business Development at
Biovector from 1994 to 1995. From 1986 to 1993, he was founder
and Managing Director of MS Medical Synergy, a company
specialized in drug delivery. From 1978 to 1985, Dr. Loria
held various positions with the pharmaceutical companies Hoffman
La Roche-Kontron, Ciba-Geigy and Sanofi Pharma.
Dr. McKearn has served as our director since
April 2000. Since March 2005, he has served as Chief Executive
Officer of Kalypsys Inc., a privately held biotechnology
company, where he also served as President and Chief Scientific
Officer from August 2004 to March 2005 and Chief Scientific
Officer from July 2003 to August 2004. In addition,
Dr. McKearn has been a member of the Board of Directors of
Kalypsys since July 2003. Prior to that, he was with Pharmacia
Corporation, formerly G.D. Searle and Co., a pharmaceutical
company, since 1987. From August 2000 until June 2003, he served
as Senior Vice President, Pharmacia Discovery Research,
responsible for research activities in cardiovascular diseases,
arthritis and oncology. Prior
38
to that he served as Vice President, Searle Discovery Research
from 1999 to 2000, Executive Director of Oncology from 1995 to
1999, and directed all arthritis, inflammation and oncology
research from 1987 to 1995. Dr. McKearn was a Senior
Scientist at E.I. DuPont de Nemours and Company, a
pharmaceutical company, from 1985 to 1987 and a member of the
Basel Institute for Immunology from 1982 to 1985.
Mr. De Vaere has served as our Vice
President, Finance and Chief Financial Officer since May 2000
and became our Vice President, Finance and Administration in
December 2001. Prior to joining us in May 2000, Mr. De
Vaere was with Vista Medical Technologies, Inc., a medical
device company, since January 1996 where he served as Vice
President of Finance and Administration and Chief Financial
Officer. Prior to his employment with Vista, he was Director of
Finance and Business Management for Kaiser Electro-Optics from
April 1993 to January 1996 and Controller for Kaiser Rollmet, an
aerospace company, from January 1991 to April 1993.
Dr. Newman has served as our Vice President,
Infectious Disease Program since March 1999 and became our Vice
President, Research and Development in September 2003. Prior to
joining Epimmune, Dr. Newman served as Vice President of
Research and Development of Vaxcel, Inc., a vaccine
delivery/adjuvant company, from January 1995 to March 1999.
Prior to joining Vaxcel, he was Associate Vice President,
Research and Development for Apollon, Inc., a DNA vaccine
company. He also previously held the position of Senior Director
at Cambridge Biotech Corporation.
Independence of the Board of Directors
As required under The Nasdaq Stock Market, or Nasdaq, listing
standards, a majority of the members of a listed companys
board of directors must qualify as independent, as
affirmatively determined by the board of directors. The Board
consults with our counsel to ensure that the Boards
determinations are consistent with all relevant securities and
other laws and regulations regarding the definition of
independent, including those set forth in relevant
listing standards of the Nasdaq, as in effect time to time.
Consistent with these considerations, after review of all
relevant transactions or relationships between each director, or
any of his family members, and us, our senior management and our
independent auditors, the Board affirmatively has determined
that all of the Companys directors are independent
directors within the meaning of , as defined in
Rule 4200(a)(15) of the Nasdaq listing standards, except
for Dr. Loria, our President and Chief Executive Officer.
Board Committees and Meetings
During the fiscal year ended December 31, 2004, the Board
held ten meetings. As required under Nasdaq listing standards,
our independent directors meet in regularly scheduled executive
sessions at which only independent directors are present.
Our Board of Directors currently has an Audit Committee, a
Compensation Committee and a Nominating Committee. The following
table provides membership information for 2004 for each of the
Board committees:
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Governance and | |
Name |
|
Audit | |
|
Compensation | |
|
Nominating | |
|
|
| |
|
| |
|
| |
Howard E. Greene, Jr.
|
|
|
X |
* |
|
|
X |
* |
|
|
|
|
William T. Comer, Ph.D.
|
|
|
X |
|
|
|
X |
|
|
|
|
|
Michael G. Grey
|
|
|
X |
|
|
|
|
|
|
|
X |
* |
John P. McKearn, Ph.D.
|
|
|
|
|
|
|
X |
|
|
|
X |
|
39
Below is a description of each committee of the Board of
Directors and information regarding committee meetings held in
2004. The Board of Directors has determined that each member of
each committee meets the applicable rules and regulations
regarding independence and that each member is free
of any relationship that would interfere with his or her
individual exercise of independent judgment with regard to us.
Audit Committee. The Audit Committee of the Board
oversees our corporate accounting and financial reporting
process. The Board of Directors has adopted an Audit Committee
Charter, which among other responsibilities, requires that this
committee monitor our financial reporting process and internal
control systems, review audit and management reports and review
and approve the engagement of the independent auditors. The
Audit Committee met a total of five times in 2004. The Audit
Committee met two times prior to March 30, 2004 to plan for
and discuss the 2003 annual audit with our independent auditors.
The Audit Committee met three times after March 30, 2004,
to review and discuss our first, second and third quarter
financial results and financial statements to be included in our
Form 10-Q filings. The Audit Committee met one time
following the 2004 fiscal year end to discuss the 2004 annual
audit with our independent auditors. The Audit Committee
recommends the independent auditors to the Board and provides a
direct line of communication between the auditors and the Board.
The independent auditors separately meet with the Audit
Committee, with and without our management present, to review
and discuss various matters, including our financial statements,
the report of the independent auditors on the results, scope and
terms of their work and their recommendations concerning the
Companys financial practices and procedures.
The Board annually reviews the Nasdaq listing standards
definition of independence for Audit Committee members and has
determined that all members of our Audit Committee are
independent, as independence is currently defined in
Rule 4350(d)(2)(A)(i) and (ii) of the Nasdaq listing
standards. The Board has determined that Mr. Greene
qualifies as an audit committee financial expert, as defined in
applicable SEC rules. The Board made a qualitative assessment of
Mr. Greenes level of knowledge and experience based
on a number of factors, including his formal education and
experience as a chief executive officer for public reporting
companies.
Compensation Committee. The Compensation Committee
of the Board of Directors reviews and approves our overall
compensation strategy and policies. The Compensation Committee
administers our stock option plans, employee stock purchase plan
and 401(k) plan, approves (or recommends to the Board for
approval) salaries, bonuses and other compensation arrangements
for our officers, including our Chief Executive Officer, and
performs such other functions regarding compensation as our
Board of Directors may delegate. All members of the Compensation
Committee are independent, as independence is currently defined
in Rule 4200(a)(15) of the Nasdaq listing standards. The
Compensation Committee held three meetings and acted by
unanimous written consent two times during 2004.
Nominating Committee. The Nominating Committee is
responsible for interviewing, evaluating, nominating and
recommending individuals for membership on our Board and
committees thereof and nominating specific individuals to be
elected as our officers by the Board. Our Nominating Committee
charter can be found on our corporate website at
www.epimmune.com. All members of the Nominating Committee are
independent, as independence is currently defined in
Rule 4200(a)(15) of the Nasdaq listing standards. The
Nominating Committee acted by unanimous written consent one time
during 2004.
Attendance at Board and Committee Meetings. During
the fiscal year ended December 31, 2004, all of the
Companys directors attended or participated in 75% or more
of the aggregate of (i) the total number of meetings of the
Board and (ii) the total number of meetings held by all
committees of the Board on which such director served during the
year.
Code of Ethics
On December 9, 2003, we adopted a Code of Business Conduct
and Ethics applicable to all of our officers, directors and
employees. If we make any substantive amendments to the Code of
Business Conduct or grant any waiver from a provision of the
code to any executive officer or director, we will promptly
disclose the nature of the amendment or waiver on our website at
www.epimmune.com.
40
|
|
Item 11. |
Executive Compensation |
Director Compensation
Non-employee directors are paid $2,000 per meeting attended
in person and $500 per meeting attended by phone as
compensation for their service on the Board. Directors are not
compensated for actions taken by written consent. The members of
the Board are eligible for reimbursement of expenses incurred in
connection with their service on the Board. Under the
Directors Deferred Compensation Plan, participating
directors may elect on an annual basis to defer all of their
cash compensation in a deferred compensation account pursuant to
which the deferred fees are credited in the form of share units
having a value equal to shares of our common stock share units,
based on the market price of the stock at the time the deferred
fees are earned. We will continue to credit share units to the
participants deferred compensation accounts on a quarterly
basis. When a participant ceases serving as a director, the
participant shall be entitled to receive the value of his or her
account either in a single lump-sum payment or in equal annual
installments, as determined by us, in our sole discretion. No
participant entitled to receive a payment of benefits shall
receive payment in the form of our common stock. Effective as of
the closing of the transactions with IDM under the Share
Exchange Agreement, each of Dr. Comer and
Messrs. Greene and Hibon will resign as a member of our
Board and Dr. Comer and Mr. Greene, who are
participants in the Directors Deferred Compensation Plan,
will be entitled to receive the value of their accounts in a
single lump-sum payment.
Directors are currently eligible to receive option grants under
our stock option plan in accordance with the policy regarding
non-employee director compensation adopted by the Board of
Directors in 1999. This policy calls for each non-employee
director to be granted annual options to
purchase 5,000 shares of our common stock as of the
date of each annual meeting of our stockholders. The shares
subject to such option are to vest monthly over a twelve-month
period, provided the director remains a director upon the date
of his re-election to our Board. Newly appointed or elected
non-employee directors are eligible for a 20,000-share option
grant under this policy with monthly vesting over a forty-eight
month period. In June 15, 2004, the Board granted annual
options to purchase 5,000 shares of our common stock
in connection with the annual meeting of our stockholders to the
following non-employee directors: Mr. Greene,
Dr. Comer, Mr. Grey, Mr. Hibon, and
Dr. McKearn at an exercise price of $1.92 per share.
In connection with the approval of the proposed combination with
IDM, our Board approved the amendment, effective as of the
closing of the IDM transaction, of certain options to purchase
shares of our common stock granted to Dr. Comer and
Messrs. Greene and Hibon, in light of their resignation
from the Board as of the closing of the transactions with IDM
under the Share Exchange Agreement, to provide that their
outstanding options shall remain exercisable until the date of
the option would have originally expired but for the resignation
of the option holder from service as our director, except that,
with respect to any options that have an exercise price less
than the fair market value of our common stock as of the date
the resolutions were adopted, such options shall remain
exercisable until the earlier of (i) the date of the
options would have originally expired but for the resignation of
the option holder from service as our director and (ii) the
latest date on which the option can expire without the option
being treated as deferred compensation under Section 409A
of the Internal Revenue Code of 1986, as amended, and the
treasury regulations thereunder and subject to the additional
tax under Section 409A (which under current guidance would
be March 15, 2006 but could be extended).
Section 16(a) Beneficial Ownership Reporting
Compliance
Section 16(a) of the Securities Exchange Act of 1934, as
amended, or the Exchange Act, requires our directors and
executive officers, and persons who own more than 10% of a
registered class of our equity securities, to file with the SEC
initial reports of ownership and reports in changes in ownership
of our common stock and other of our equity securities. Specific
due dates for these reports have been established, and we are
required to disclose any failure to file by these dates during
2004. Our officers, directors and greater than 10% stockholders
are required by the SEC regulations to furnish us with copies of
all Section 16(a) forms they file.
41
Compensation of Executive Officers
The following table shows for the fiscal years ended
December 31, 2004, 2003 and 2002, compensation awarded or
paid to, or earned by our Chief Executive Officer and our two
other most highly compensated executive officers. These
individuals are referred to as the named executive
officers. During the last three fiscal years, none of the
executive officers received any restricted stock awards or
long-term incentive payouts; provided, however, Dr. Loria
purchased stock from us in 2001 that was subject to vesting.
Summary Compensation Table
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|
|
|
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|
Long-Term | |
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|
|
|
|
|
|
Compensation Awards | |
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|
|
|
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| |
|
|
|
|
Annual Compensation(1) | |
|
Restricted | |
|
Securities | |
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|
|
|
| |
|
Stock | |
|
Underlying | |
|
All Other | |
|
|
|
|
Bonus | |
|
Awards | |
|
Options | |
|
Compensation | |
Name and Principal Position |
|
Year | |
|
Salary($) | |
|
($)(2) | |
|
($) | |
|
(#) | |
|
($)(3) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Dr. Emile Loria(4)(5)(6)(9)
|
|
|
2004 |
|
|
|
350,000 |
|
|
|
50,000 |
|
|
|
0 |
|
|
|
500,000 |
|
|
|
2,408 |
|
|
President, Chief Executive Officer |
|
|
2003 |
|
|
|
350,000 |
|
|
|
25,000 |
|
|
|
0 |
|
|
|
500,000 |
|
|
|
1,387 |
|
|
|
|
|
2002 |
|
|
|
300,000 |
|
|
|
100,098 |
|
|
|
0 |
|
|
|
0 |
|
|
|
1,058 |
|
Dr. Mark J. Newman(7)(9)
|
|
|
2004 |
|
|
|
225,000 |
|
|
|
50,000 |
|
|
|
0 |
|
|
|
160,000 |
|
|
|
828 |
|
|
Vice President, Research and |
|
|
2003 |
|
|
|
195,833 |
|
|
|
25,000 |
|
|
|
0 |
|
|
|
50,000 |
|
|
|
724 |
|
|
Development & Asst. Secretary |
|
|
2002 |
|
|
|
185,000 |
|
|
|
98 |
|
|
|
0 |
|
|
|
0 |
|
|
|
597 |
|
Mr. Robert J. De Vaere(8)(9)
|
|
|
2004 |
|
|
|
215,000 |
|
|
|
50,000 |
|
|
|
0 |
|
|
|
160,000 |
|
|
|
789 |
|
|
Vice President, Finance and |
|
|
2003 |
|
|
|
195,000 |
|
|
|
25,000 |
|
|
|
0 |
|
|
|
50,000 |
|
|
|
724 |
|
|
Administration, Chief Financial |
|
|
2002 |
|
|
|
185,000 |
|
|
|
98 |
|
|
|
0 |
|
|
|
0 |
|
|
|
398 |
|
|
Officer and Secretary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
(1) |
As permitted by rules promulgated by the SEC, no amounts are
shown with respect to certain perquisites, where
such amounts do not exceed the lesser of 10% of bonus plus
salary or $50,000, in the column Other Annual
Compensation. Accordingly, because no amounts would be
included in this column, we have excluded this column from the
above table. |
|
(2) |
All officers of the Company were granted a stock bonus award
during 2002 of 100 shares of our common stock in exchange
for the termination of their participation in the 2002
Management Bonus Plan. The fair market value of our common stock
on December 16, 2002, the issuance date, was $0.98 per
share, or $98 for each award. |
|
(3) |
All other compensation consists of life insurance premiums paid
by us unless otherwise noted. |
|
(4) |
Dr. Loria joined as our President and Chief Executive
Officer in June 2001 at an annual salary of $300,000.
Dr. Loria received a signing bonus of $125,000 and was
eligible to earn a performance bonus equal to two percent of any
proceeds received by us from any public or private equity
financing or other transaction pursuant to which we received
funding (other than research funding) that was completed by us
between January 16, 2001 and January 16, 2002. During
the period from January 16, 2001 and January 16, 2002,
we completed transactions in which we received total funding of
$16,379,581 making Dr. Loria eligible for bonus payments of
$327,592 under the provisions of this agreement. Dr. Loria
was paid a bonus of $227,592 in 2001 and the remaining accrued
balance of $100,000 was paid in January 2002. |
|
(5) |
Dr. Loria joined as our President and Chief Executive
Officer in June 2001. In connection with his employment offer
letter and joining our Board of Directors in January 2001, and
as an inducement to accept the offer, we sold Dr. Loria
1,056,301 shares of our common stock at a purchase price of
$2.50 per share, the closing price of our common stock on
the Nasdaq National Market on the date of purchase. The shares
were subject to vesting in equal daily installments during the
four-year period following the date of purchase, and we had a
right to purchase any unvested shares at the purchase price paid
by Dr. Loria in the event of termination of
Dr. Lorias service to Epimmune. Dr. Loria issued
us a promissory note for $2,641,000, the aggregate purchase
price of the shares, which is secured by a pledge of the shares.
In September 2003, Dr. Loria surrendered an aggregate of
963,740 shares of our common |
42
|
|
|
stock at the fair market value of $3.17 per share, in
exchange for the prepayment of the outstanding principal and
interest under the promissory note. |
|
(6) |
Of the 500,000 options granted to Dr. Loria in 2004,
187,500 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
|
(7) |
Of the 160,000 options granted to Dr. Newman in 2004,
60,000 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
|
(8) |
Of the 160,000 options granted to Mr. De Vaere in 2004,
60,000 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
|
(9) |
The performance milestones associated with the contingent option
grants included: completion of a licensing transaction with a
third party to assist in the development of any cancer or HIV
vaccine candidate; completion of an equity financing of at least
$10 million; and enrollment (injection) of the first
patient in any Phase II clinical trial. |
Our Board approved salaries for our executive officers for 2005,
which will be effective January 1, 2005 but only if the
closing of the proposed transactions with IDM under the Share
Exchange Agreement occur, as set forth in the following table.
Our Board also approved the payment of bonuses, to be made only
if the closing of the proposed transactions with IDM under the
Share Exchange Agreement occur, to all of our employees who are
employed at the time of the closing, including the executive
officers set forth in the following table.
|
|
|
|
|
|
|
|
|
Executive Officer |
|
2005 Salary ($)(1) | |
|
Amount of Bonus ($)(1) | |
|
|
| |
|
| |
Emile Loria,
|
|
|
375,000 |
|
|
|
375,000 [12 months of |
|
President and Chief Executive Officer
|
|
|
|
|
|
|
then current salary] |
|
Mark Newman,
|
|
|
235,000 |
|
|
|
117,500 [six months |
|
Vice President, Research and Development
|
|
|
|
|
|
|
of then current salary] |
|
Robert De Vaere,
|
|
|
235,000 |
|
|
|
117,500 [six months of |
|
Vice President, Finance, and Chief Financial Officer
|
|
|
|
|
|
|
then current salary] |
|
|
|
(1) |
Effective only upon the closing of the proposed combination with
IDM. |
Stock Option Grants and Exercises
We currently grant options to our executive officers under our
2000 Stock Plan and have previously granted options under our
1997 Stock Plan and our 1989 Stock Option Plan, which terminated
in 1999. As of December 31, 2004, options to purchase a
total of 219,798 shares were outstanding under the 1989
Stock Option Plan, options to purchase a total of
7,140 shares were outstanding under the 1994 Non-Employee
Directors Stock Option Plan, options to purchase a total
of 119,209 shares were outstanding under the 1997 Stock
Plan and options to purchase a total of 2,175,000 shares
were outstanding under the 2000 Stock Plan. On December 16,
2002 we granted stock bonus awards of 600 shares to our
executive officers from the 2000 Plan. There are no options
available for grant under the 1997 Stock Plan, the 1989 Stock
Option Plan or the 1994 Non-Employee Directors Stock
Option Plan. As of December 31, 2004, 399,393 options were
available for future grant under the 2000 Stock Plan.
Options granted under the 1989 Stock Option Plan prior to 1996
generally vested 20% at the end of the first year of the
optionees employment and thereafter daily at the rate of
20% per year during such period of employment. Options
granted under the 1989 Stock Option Plan after November 1996 and
options granted under the 2000 Stock Plan generally vest 25% at
the end of the first year of the optionees employment and
thereafter daily at the rate of 25% per year during such
period of employment. Options granted under the 1997 Plan which
we assumed from a subsidiary, generally vest 25% at the end of
the first year of the optionees employment and thereafter
monthly at the rate of 25% per year during such period of
employment.
43
The potential realizable value shown in the table below is
calculated based on the terms of the option at its time of grant
(10 years in the case of all options). It is calculated by
assuming that the stock price on the date of grant appreciates
at the indicated annual rate, compounded annually for the entire
term of the option and that the option is exercised and sold on
the last day of its term for the appreciated stock price. These
amounts represent certain assumed rates of appreciation, in
accordance with rules of the SEC, and do not reflect our
estimate or projection of future stock price performance. Actual
gains, if any, are dependent on the actual future performance of
our common stock, and no gain to the optionee is possible unless
the stock price increases over the option term, which will
benefit all stockholders.
The following tables show for the fiscal year ended
December 31, 2004, certain information regarding options
granted to, exercised by, and held at year-end by the named
executive officers:
Options Granted in Last Fiscal Year
|
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|
|
Individual Grants | |
|
|
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| |
|
Potential Realizable | |
|
|
Number | |
|
% Total | |
|
|
|
Value at Assumed | |
|
|
of | |
|
Options | |
|
|
|
Annual Rates of Stock | |
|
|
Securities | |
|
Granted to | |
|
|
|
Price Appreciation for | |
|
|
Underlying | |
|
Employees | |
|
Exercise or | |
|
|
|
Option Term(2) | |
|
|
Options | |
|
In Fiscal | |
|
Base Price | |
|
Expiration | |
|
| |
Name |
|
Granted | |
|
Year(1) | |
|
($/Sh) | |
|
Date | |
|
5%($) | |
|
10%($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Dr. Emile Loria(3)(6)
|
|
|
250,000 |
|
|
|
21.80 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
240,552 |
|
|
|
609,606 |
|
|
|
|
62,500 |
|
|
|
5.45 |
% |
|
|
1.92000 |
|
|
|
06/15/14 |
|
|
|
75,467 |
|
|
|
191,249 |
|
|
|
|
62,500 |
|
|
|
5.45 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
60,138 |
|
|
|
152,502 |
|
|
|
|
62,500 |
|
|
|
5.45 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
60,138 |
|
|
|
152,502 |
|
|
|
|
62,500 |
|
|
|
5.45 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
60,138 |
|
|
|
152,502 |
|
Dr. Mark J. Newman(4)(6)
|
|
|
80,000 |
|
|
|
6.97 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
76,977 |
|
|
|
195,074 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.92000 |
|
|
|
06/15/14 |
|
|
|
24,150 |
|
|
|
61,200 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
Mr. Robert J. De Vaere(5)(6)
|
|
|
80,000 |
|
|
|
6.97 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
76,977 |
|
|
|
195,074 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.92000 |
|
|
|
06/15/14 |
|
|
|
24,150 |
|
|
|
61,200 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
|
|
|
20,000 |
|
|
|
1.74 |
% |
|
|
1.53000 |
|
|
|
12/26/13 |
|
|
|
19,244 |
|
|
|
48,769 |
|
|
|
(1) |
Based on 1,147,000 options granted in 2004 under the 2000 Plan,
including grants to executive officers. |
|
(2) |
The potential realizable value is calculated based on the terms
of the option at its time of grant (10 years in the case of
all options). It is calculated by assuming that the stock price
on the date of grant appreciates at the indicated annual rate,
compounded annually for the entire term of the option and that
the option is exercised and sold on the last day of its term for
the appreciated stock price. These amounts represent certain
assumed rates of appreciation, in accordance with rules of the
SEC, and do not reflect the Companys estimate or
projection of future stock price performance. Actual gains, if
any, are dependent on the actual future performance of the
Companys Common Stock, and no gain to the optionee is
possible unless the stock price increases over the option term,
which will benefit all stockholders. |
|
(3) |
Of the 500,000 options granted to Dr. Loria in 2004,
187,500 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
|
(4) |
Of the 160,000 options granted to Dr. Newman in 2004,
60,000 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
44
|
|
(5) |
Of the 160,000 options granted to Mr. De Vaere in 2004,
60,000 were contingent upon the achievement of certain
performance milestones by specific dates. These performance
milestones were not met and the option grants associated with
them subsequently terminated. |
|
(6) |
The performance milestones associated with the contingent option
grants included: completion of a licensing transaction with a
third party to assist in the development of any cancer or HIV
vaccine candidate; completion of an equity financing of at least
$10 million; and enrollment (injection) of the first
patient in any Phase II clinical trial. |
Aggregated Option Exercises in Last Fiscal Year and Fiscal
Year-End Option Values
The following table sets forth summary information with respect
to exercisable and unexercisable stock options held as of
December 31, 2004 by each of the named executive officers.
None of the named executive officers exercised options in the
fiscal year ended December 31, 2004. The value of the stock
options is calculated using the fair market value of our common
stock on December 31, 2004 ($1.66 per share) minus the
exercise price of the options.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
Value of Unexercised | |
|
|
|
|
|
|
Underlying Unexercised | |
|
In-the-Money Options | |
|
|
|
|
|
|
Options at December 31, | |
|
at December 31, | |
|
|
|
|
|
|
2004 | |
|
2004 | |
|
|
Shares | |
|
|
|
| |
|
| |
|
|
Acquired | |
|
Value | |
|
Exercisable/ | |
|
Exercisable/ | |
Name |
|
on Exercise | |
|
Realized | |
|
Unexercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
Dr. Emile Loria
|
|
|
|
|
|
|
|
|
|
|
454,301/ 483,199 |
|
|
$ |
47,651/ $61,099 |
|
Dr. Mark J. Newman
|
|
|
|
|
|
|
|
|
|
|
241,996/ 125,470 |
|
|
$ |
79,092/ $14,401 |
|
Mr. Robert J. De Vaere
|
|
|
|
|
|
|
|
|
|
|
245,387/ 124,613 |
|
|
$ |
6,581/ $15,019 |
|
Employment, Change of Control and Separation Agreements
Current Agreements. In May 2000, we entered into
severance benefits agreements with Dr. Newman, Vice
President, Research and Development, and Mr. Robert De
Vaere, Vice President, Finance and Administration and Chief
Financial Officer. In March 2001, the severance agreements with
Dr. Newman and Mr. De Vaere were amended. Under the
agreements, as amended, in the event Dr. Newman or
Mr. De Vaere is terminated without cause within one year
following a change of control of us, he shall receive a lump-sum
payment equal to twelve months of his annual base salary, and
all of his unvested stock options shall immediately vest and
become exercisable.
In January 2001, we entered into an employment agreement with
Dr. Emile Loria, one of our directors, for the position of
President and Chief Executive Officer, contingent upon obtaining
satisfactory approval to work in the United States.
Dr. Loria subsequently obtained such approval in June 2001.
The agreement provided an annual salary of $300,000 for
Dr. Loria. In addition, Dr. Loria was eligible to earn
a performance bonus equal to two percent of any proceeds
received by us from any public or private equity financing or
other transaction pursuant to which we received funding (other
than research funding) that was completed by us between
January 16, 2001 and January 16, 2002. We also agreed
to pay Dr. Loria a signing bonus of $125,000, certain of
his relocation expenses, including the costs of moving household
goods to San Diego, temporary furnished living
accommodations in San Diego for six months, automobile
rental costs in San Diego for up to six months and cost of
up to three trips for him and his family to and from France
(such expenses were approximately $200,000), and agreed to pay
him $60,000 to assist him in his relocation.
In addition, in January 2001, we sold Dr. Loria
1,056,301 shares of our common stock at the closing price
of such common stock as reported by the Nasdaq National Market
on the date of purchase, which was $2.50 per share. These
shares vest in equal daily installments over the four-year
period following the purchase date and we have a right to
purchase any unvested shares at the purchase price paid by
Dr. Loria in the event of termination of
Dr. Lorias service to us. Dr. Loria purchased
the shares with a promissory note in the principal amount of
$2,641,000, which is secured by a pledge of the shares. The note
bears interest at the rate of 5.61% per year, compounded
annually. In September 2003, Dr. Loria surrendered an
aggregate of
45
963,740 shares of our common stock at the fair market value
of $3.17 per share, in exchange for the prepayment of the
outstanding principal and interest under the promissory note, a
total of $3,055,000.
Under the terms of the employment agreement, Dr. Loria is
entitled to continued salary payments for twelve months in the
event he is terminated without cause or voluntarily resigns for
good reason. In addition, if Dr. Loria is terminated
without cause or voluntarily resigns for good reason following a
change in control of Epimmune, then Dr. Loria is entitled
to receive a lump sum payment equal to one year of his base
salary and all of the unvested shares he initially purchased
from us will become fully vested.
In February 2004, we entered into an accelerated benefits
agreement with Dr. Loria. Under the terms of the agreement,
if Dr. Loria is terminated without cause or voluntarily
resigns for good reason within one year following a change of
control of Epimmune, then any stock options granted to him after
December 9, 2003, which are unvested shall immediately vest
and become exercisable.
New Agreements Effective upon Closing of Transactions
under Share Exchange Agreement. On March 16, 2005,
we entered into employment agreements with Drs. Loria and
Mark Newman and Mr. De Vaere, our current President and
Chief Executive Officer, Vice President, Research and
Development, and Chief Financial Officer and Vice President,
Finance and Administration and Secretary, respectively. The
employment agreements will become effective upon the closing of
the proposed combination with IDM, will supercede the prior
employment agreements between us and these individuals, and will
provide that Dr. Loria will become our President and Chief
Business Officer, Dr. Newman will become our Vice
President, Infectious Diseases, and Mr. De Vaere will be
our Chief Financial Officer and Vice President following the
closing. The employment agreements provide for a minimum annual
salary of $375,000 for Dr. Loria and $235,000 for each of
Mr. De Vaere and Dr. Newman and the grant to each
executive of the right to receive a restricted stock grant.
Pursuant to the terms of the restricted stock grants,
Drs. Loria and Newman, and Mr. De Vaere are eligible
to receive up to 370,700 shares, 128,300 shares, and
127,200 shares, respectively. The restricted stock grants
are subject to the following terms:
|
|
|
|
|
the restricted stock vests in one or more installments, subject
to continuous employment with us through the applicable
installment date; |
|
|
|
the restricted stock is subject to accelerated vesting upon the
closing of a transaction providing a specified level of
financing to us, or the closing of a transaction providing a
specified level of funding to our infectious disease business,
or both, depending on the executive; and |
|
|
|
shares subject to the restricted stock grant that become vested
will be issued to the executive on the earlier of (i) the
executives termination, or (ii) 36 months from
the date of the agreement. |
Each agreement provides for continued exercisability of
outstanding options granted to the executive prior to the
effective date of the agreement, to the extent the options were
not in the money on the effective date of the agreement,
generally until the later of (i) three months after
executives termination, or (ii) December 31,
2007.
The agreements with Dr. Newman and Mr. De Vaere
provide for the grant of retention bonuses, as follows:
|
|
|
|
|
Dr. Newman will be eligible for up to two retention bonuses
at six and 12 months after the date of his agreement equal,
in total, to 50% of his annual salary if he has been employed by
us through the applicable bonus date; upon closing of a
transaction providing a specified level of funding for our
infectious disease business, any such retention bonuses not
previously earned will be paid immediately; |
|
|
|
Mr. De Vaere will be eligible for up to three retention
bonuses at six, nine, and 12 months after the date of his
agreement, equal, in total, to 100% of his annual salary if he
has been employed by us through the applicable bonus date. |
In case of a termination of the executives employment due
to death or disability during the term of his agreement, the
executive will be entitled to full acceleration of vesting and
exercisability of any outstanding options granted before the
effective date of the agreement. In the event that we terminate
an executives
46
employment without cause (as defined in the agreement), or the
executive terminates his employment with good reason (as defined
in the agreement), in each case during the term of his
agreement, or upon the expiration of the term of his agreement,
the executive will be entitled to, subject to the execution by
the executive of an effective waiver and release of claims
against the combined company:
|
|
|
|
|
severance payments, consisting of the executives base
salary in effect at the time of termination, paid for a period
of 12 months in the case of termination without cause, and,
in the case of termination by the executive with good reason or
upon the expiration of the agreement, such severance shall be
paid from the date of termination until the earlier of
12 months or until the date the executive begins full time
employment with another entity; |
|
|
|
reimbursement for a portion of COBRA health insurance premiums
for a period of up to 12 months; |
|
|
|
full acceleration, as of the date of termination, of vesting and
exercisability of any outstanding options granted before the
effective date of the agreement, and |
|
|
|
full acceleration of vesting and exercisability of any unvested
restricted stock granted pursuant the agreement. |
On March 15, 2005, our Board interpreted the terms of
options to purchase our common stock, which were previously
granted to all of our employees in September 2003, including
options to purchase 500,000 shares of common stock
held by Dr. Loria, options to
purchase 35,000 shares of common stock held by
Dr. Newman and options to
purchase 50,000 shares of common stock held by
Mr. De Vaere. Under their original terms these options
would vest in full upon a change in control of our company and
the Board clarified that the proposed combination with IDM would
constitute a change in control so that those options that remain
unvested will accelerate and vest in full as of the closing of
the proposed combination.
Compensation Committee Interlocks and Insider
Participation
Mr. Greene, a member of the Compensation Committee, is
Chairman of our Board of Directors.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
Equity Compensation Plan Information
The following table sets forth certain information as of
December 31, 2004 regarding our equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) | |
|
(b) | |
|
(c) | |
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
|
|
Remaining Available | |
|
|
|
|
Weighted-average | |
|
for Issuance Under | |
|
|
Number of Securities | |
|
Exercise Price of | |
|
Equity Compensation | |
|
|
to be Issued Upon | |
|
Outstanding | |
|
Plans (Excluding | |
|
|
Exercise of Options, | |
|
Options, Warrants | |
|
Securities Reflected | |
Name of Plan |
|
Warrants and Rights | |
|
and Rights | |
|
in Column (a)) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
2,521,147 |
|
|
$ |
2.06 |
|
|
|
399,393 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
$ |
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
2,521,147 |
|
|
$ |
2.06 |
|
|
|
399,393 |
|
|
|
|
|
|
|
|
|
|
|
The Company does not have in effect any equity compensation
plans under which Epimmunes equity securities are
authorized for issuance that were adopted without the approval
of Epimmunes security holders.
The following table sets forth certain information regarding the
ownership of our common stock as of February 1, 2005 by
(i) each director and nominee; (ii) each of the named
executives; (iii) all executive
47
officers and directors as a group; and (iv) all those known
by us to be beneficial owners of more than five percent of our
common stock:
|
|
|
|
|
|
|
|
|
|
|
Beneficial Ownership(1) | |
|
|
| |
|
|
Number of | |
|
Percent of | |
Beneficial Owner |
|
Shares | |
|
Shares | |
|
|
| |
|
| |
G.D. Searle LLC(2)
235 East
42nd Street
New York, NY 10017
|
|
|
2,105,032 |
|
|
|
11.8 |
% |
Genencor International, Inc.
200 Meridian Centre Blvd.
Rochester, NY 14618
|
|
|
1,342,324 |
|
|
|
8.4 |
% |
International Biotechnology Trust plc
71 Kingsway
London, WC2B 6ST, England
|
|
|
1,279,659 |
|
|
|
8.0 |
% |
Mr. Peter Allard(3)
Seaview, Chancery Lane
Christ Church, Barbados, West Indies
|
|
|
1,204,716 |
|
|
|
7.5 |
% |
The Animi Master Fund Ltd.(4)
c/o Archeus Capital Management Ltd.
360 Madison Avenue,
10th
Floor
New York, NY 10014
|
|
|
1,016,949 |
|
|
|
6.2 |
% |
Dr. Emile Loria(5)
|
|
|
688,133 |
|
|
|
4.1 |
% |
Dr. Mark J. Newman(5)
|
|
|
289,649 |
|
|
|
1.8 |
% |
Mr. Robert J. De Vaere(5)
|
|
|
286,926 |
|
|
|
1.8 |
% |
Mr. Howard E. (Ted) Greene, Jr.(5)(6)(7)
|
|
|
246,431 |
|
|
|
1.5 |
% |
Dr. William T. Comer(5)
|
|
|
48,948 |
|
|
|
* |
|
Mr. Michael Grey(5)
|
|
|
43,750 |
|
|
|
* |
|
Mr. Georges Hibon(5)
|
|
|
31,667 |
|
|
|
* |
|
Dr. John P. McKearn(5)
|
|
|
30,000 |
|
|
|
* |
|
All executive officers and directors as a group (8 persons)(8)
|
|
|
1,665,504 |
|
|
|
9.6 |
% |
|
|
(1) |
This table is based upon information supplied by officers,
directors and principal stockholders and on any Schedules 13D or
13G filed with the Securities and Exchange Commission, or the
SEC. Unless otherwise indicated in the footnotes to this table
and subject to community property laws where applicable, each
stockholder named in this table has sole voting and investment
power with respect to the shares indicated as beneficially
owned. Applicable percentage ownership is based on
16,014,569 shares of Common Stock outstanding on
February 1, 2005, as adjusted by the rules promulgated by
the SEC. |
|
(2) |
Includes 1,787,572 shares of Common Stock issuable upon
conversion of shares of Series S Preferred Stock and
Series S-1 Preferred Stock held by Pfizer, Inc., through
G.D. Searle, provided that Pfizer is not entitled to vote such
shares to the extent that the total number of shares of voting
capital stock held by Pfizer and its affiliates would exceed
19.9%. Pfizer owns 100% of the outstanding shares of the
Series S Preferred Stock and Series S-1 Preferred
Stock. The Series S Preferred Stock and Series S-1
Preferred Stock are convertible into Common Stock at any time. |
|
(3) |
Includes 141,943 shares of common stock underlying
currently exercisable warrants. |
|
(4) |
Includes 338,983 shares of common stock underlying
currently exercisable warrants. |
48
|
|
(5) |
Includes shares, which certain executive officers and directors
of the Company have the right to acquire within 60 days
after February 1, 2005 pursuant to outstanding options, as
follows: |
|
|
|
Dr. William T. Comer, 48,034 shares;
Mr. Robert J. De Vaere, 279,221 shares;
Mr. Howard E. (Ted) Greene, Jr.,
46,606 shares;
Mr. Michael G. Grey, 43,750 shares;
Mr. Georges Hibon, 31,667 shares;
Dr. Emile Loria, 595,472 shares;
Dr. John P. McKearn, 30,000 shares;
Dr. Mark J. Newman, 273,710 shares;
All executive officers and directors as a group,
1,371,058 shares. |
|
|
(6) |
Includes 174,942 shares held in trust for the benefit of
Mr. Greene and his wife and 2,285 shares held in trust
for the benefit of Mr. Greenes children.
Mr. Greene is a trustee of both trusts. Mr. Greene
acting as trustee has voting and investment power with respect
to such shares and may be deemed to be the beneficial owner of
such shares. |
|
(7) |
Includes 22,598 shares of common stock underlying currently
exercisable warrants. |
|
(8) |
Includes shares described in notes (5) through
(7) above. |
|
|
Item 13. |
Certain Relationships and Related Transactions |
Our bylaws provide that we will indemnify our directors and
executive officers and may indemnify our other officers,
employees and other agents to the fullest extent permitted by
Delaware law. We are also empowered under our bylaws to enter
into indemnification contracts with our directors and officers
and to purchase insurance on behalf of any person whom it is
required or permitted to indemnify. Pursuant to this provision,
we have entered into indemnity agreements with each of our
directors and executive officers.
In addition, our certificate of incorporation provides that to
the fullest extent permitted by Delaware law, our directors will
not be liable for monetary damages for breach of the
directors fiduciary duty of care to us and our
stockholders. This provision in the certificate of incorporation
does not eliminate the duty of care, and in appropriate
circumstances equitable remedies such as an injunction or other
forms of non-monetary relief would remain available under
Delaware law. Each director will continue to be subject to
liability for breach of the directors duty of loyalty to
us, for acts or omissions not in good faith or involving
intentional misconduct or knowing violations of law, for acts or
omissions that the director believes to be contrary to our best
interests or our stockholders, for any transaction from which
the director derived an improper personal benefit, for acts or
omissions involving a reckless disregard for the directors
duty to us or our stockholders when the director was aware or
should have been aware of a risk of serious injury to us or our
stockholders, for acts or omissions that constitute an unexcused
pattern of inattention that amounts to an abdication of the
directors duty to us or our stockholders, for improper
transactions between the director and us, and for improper
distributions to stockholders and loans to directors and
officers. This provision also does not affect a directors
responsibilities under any other laws, such as the federal
securities laws or state or federal environmental laws.
On March 15, 2005, we entered into a preferred exchange
agreement with G.D. Searle LLC, the holder of all of the
outstanding shares of our preferred stock. Pursuant to this
agreement, effective immediately prior to the closing of the
proposed combination with IDM, 859,666 shares of the our
Series S preferred stock and 549,622 shares of our
Series S-1 preferred stock will be exchanged for an
aggregate of 1,949,278 shares of our common stock.
On March 15, 2005, we entered into a voting agreement with
our directors and executive officers pursuant to which they
agreed, among other things, to vote the shares of our common
stock that they hold in favor of the share exchange with the
shareholders of IDM and other transactions contemplated by the
share exchange agreement that will be submitted for approval by
our stockholders.
We have entered into certain additional transactions with our
directors and officers, as described under the captions
Executive Compensation and Employment
Agreements.
49
|
|
Item 14. |
Principal Accountant Fees and Services |
The following table sets forth the aggregate fees billed or to
be billed by Ernst & Young LLP, Independent Registered
Public Accounting Firm, to us for the fiscal years ended
December 31, 2004 and 2003:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Audit Fees(1)
|
|
$ |
143,000 |
|
|
$ |
124,000 |
|
Audit Related Fees(2)
|
|
|
110,000 |
|
|
|
10,000 |
|
Tax Related Fees(3)
|
|
|
34,000 |
|
|
|
27,000 |
|
All Other Fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
287,000 |
|
|
$ |
161,000 |
|
|
|
|
|
|
|
|
|
|
(1) |
Audit fees relate to the audit of our consolidated financial
statements and reviews of our consolidated financial statements
included in our Form 10-Qs for 2004, accounting
consultations, and review of documents filed with the SEC. |
|
(2) |
Audit related fees relate primarily to due diligence associated
with a proposed business combination. |
|
(3) |
Tax related fees are for services related to tax compliance, tax
advice and tax planning. |
|
|
|
All fees described above were approved in advance by our Audit
Committee. |
Pre-Approval Policies and Procedures.
Our Audit Committee has adopted a policy and procedures for the
pre-approval of audit and non-audit services rendered by
Ernst & Young, Independent Registered Public Accounting
Firm. The policy generally pre-approves specified services in
the defined categories of audit services, audit-related
services, and tax services up to specified amounts. Pre-approval
may also be given as part of our Audit Committees approval
of the scope of the engagement of the independent auditor or on
an individual explicit case-by-case basis before the independent
auditor is engaged to provide each service. The pre-approval of
services may be delegated to one or more of our Audit
Committees members, but the decision must be reported to
the full Audit Committee at its next scheduled meeting.
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules |
|
|
(a)(1) |
Index to Financial Statements |
The consolidated financial statements required by this item are
submitted in a separate section beginning on page F-1 of this
Report.
|
|
|
|
|
|
|
Page | |
|
|
| |
Report of Ernst & Young LLP, Independent Registered
Public Accounting Firm
|
|
|
F-2 |
|
Consolidated Balance Sheets as of December 31, 2004 and 2003
|
|
|
F-3 |
|
Consolidated Statements of Operations for each of the three
years in the period ended December 31, 2004
|
|
|
F-4 |
|
Consolidated Statements of Stockholders Equity for each of
the three years in the period ended December 31, 2004
|
|
|
F-5 |
|
Consolidated Statements of Cash Flows for each of the three
years in the period ended December 31, 2004
|
|
|
F-6 |
|
Notes to Consolidated Financial Statements
|
|
|
F-7 - F-23 |
|
50
|
|
(2) |
Index to Financial Statement Schedules |
The consolidated financial statement schedules required by this
item are omitted because they are not applicable or the required
information is shown in the Financial Statements or the notes
thereto.
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
|
|
Document Description |
|
|
|
|
|
|
3 |
.1 |
|
|
|
Amended and Restated Certificate of Incorporation filed with the
Secretary of State of Delaware on December 2, 1991.(1) |
|
|
3 |
.2 |
|
|
|
Certificate of Designation of Series A Junior Participating
Preferred Stock filed with the Secretary of State of Delaware on
April 2, 1993.(2) |
|
|
3 |
.3 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
July 5, 1995.(3) |
|
|
3 |
.4 |
|
|
|
Certificate of Increase of Series A Junior Participating
Preferred Stock filed with the Secretary of State of Delaware on
July 5, 1995 |
|
|
3 |
.5 |
|
|
|
Certificate of Increase of Series A Junior Participating
Preferred Stock filed with the Secretary of State of Delaware on
July 2, 1998.(4) |
|
|
3 |
.6 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
July 2, 1998.(4) |
|
|
3 |
.7 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
November 12, 1998.(5) |
|
|
3 |
.8 |
|
|
|
Certificate of Designations of the Series S and
Series S-1 Preferred Stock filed with the Secretary of
State of Delaware on June 29, 1999.(7) |
|
|
3 |
.9 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
July 1, 1999.(8) |
|
|
3 |
.10 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
September 23, 1999.(9) |
|
|
3 |
.11 |
|
|
|
Certificate of Decrease of Series A Junior Participating
Preferred Stock filed with the Secretary of State of Delaware on
September 23, 1999.(9) |
|
|
3 |
.12 |
|
|
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation filed with the Secretary of State of Delaware on
June17, 2004.(28) |
|
|
3 |
.13 |
|
|
|
Amended and Restated Bylaws of the Registrant.(18) |
|
|
4 |
.1 |
|
|
|
Reference is made to Exhibits 3.1 through 3.13 |
|
|
4 |
.2 |
|
|
|
Specimen certificate of the Common stock.(1) |
|
|
10 |
.1 |
|
|
|
Form of Indemnification Agreement entered into between Epimmune
and its directors and officers.(1)(*) |
|
|
10 |
.2 |
|
|
|
Registrants 1989 Stock Plan, as amended through
June 12, 1998 (the 1989 Plan).(4) |
|
|
10 |
.3 |
|
|
|
Forms of Incentive Stock Option Agreement under the 1989 Plan.(1) |
|
|
10 |
.4 |
|
|
|
Form of Nonstatutory Stock Option Agreement under the 1989
Plan.(1) |
|
|
10 |
.5 |
|
|
|
Research Agreement, between Epimmune and The Scripps Research
Institute, formerly Scripps Clinic and Research Foundation
(Scripps), dated as of September 1, 1990, as
amended August 5, 1991 (with certain confidential portions
deleted).(1)(A) |
|
|
10 |
.6 |
|
|
|
License Agreement, between Epimmune and Scripps, dated as of
September 23, 1991 (with certain confidential portions
deleted).(1)(A) |
|
|
10 |
.7 |
|
|
|
Amendment to License Agreement between Epimmune and Scripps
dated as of June 17, 1992 (with certain confidential
portions deleted).(1)(B) |
|
|
10 |
.8 |
|
|
|
Registrants 1994 Non-Employee Directors Stock Option
Plan, as amended through June 12, 1998.(4)(*) |
51
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Document Description |
| |
|
|
|
|
|
|
10 |
.9 |
|
|
|
Second Amendment to License Agreement between Epimmune and
Scripps dated as of June 17, 1992 (with certain
confidential portions deleted.(1)(B) |
|
|
10 |
.10 |
|
|
|
Directors Deferred Compensation Plan, effective as of
March 17, 1995, as amended September 20, 1996 and
July 13, 1999.(21)(*) |
|
|
10 |
.11 |
|
|
|
Lease Agreement between Epimmune Inc. and Nexus Equity LLC VIII,
dated as of November 1, 1998, as amended February 1,
1999 and December 20, 2004.(6) |
|
|
10 |
.12 |
|
|
|
Preferred Stock Exchange Agreement, dated July 1, 1999, by
and between the Company and G.D. Searle & Co.(7) |
|
|
10 |
.13 |
|
|
|
Investor Rights Agreement, dated as of July 1, 1999, by and
between the Company and G.D. Searle & Co.(7) |
|
|
10 |
.14 |
|
|
|
Form of Common Stock Purchase agreement dated February 15,
2000.(10) |
|
|
10 |
.15 |
|
|
|
Letter Agreement between Epimmune and Robert De Vaere dated
May 4, 2000.(11)(*) |
|
|
10 |
.16 |
|
|
|
Letter Agreement between Epimmune and Mark Newman dated
May 4, 2000.(11)(*) |
|
|
10 |
.17 |
|
|
|
Form of Common Stock Purchase Agreement dated October 16,
2000.(12) |
|
|
10 |
.18 |
|
|
|
Non-Exclusive License Agreement between Epimmune and Valentis,
Inc., dated November 27, 2000 (with certain confidential
portions deleted).(12)(C) |
|
|
10 |
.19 |
|
|
|
Letter Agreement between Epimmune and Dr. Emile Loria
regarding employment terms dated January 16, 2001.(13)(*) |
|
|
10 |
.20 |
|
|
|
Form of Restricted Stock Purchase Agreement between Epimmune and
Dr. Emile Loria dated January 16, 2001.(13)(*) |
|
|
10 |
.21 |
|
|
|
Amendment to Severance Benefits Agreement between Epimmune and
Dr. Mark Newman dated March 8, 2001.(13)(*) |
|
|
10 |
.22 |
|
|
|
Amendment to Severance Benefits Agreement between Epimmune and
Robert De Vaere dated March 8, 2001.(13)(*) |
|
|
10 |
.23 |
|
|
|
Non-exclusive License Agreement between Epimmune and Pharmexa A/
S dated June 25, 2001 (with certain confidential portions
deleted).(15)(D) |
|
|
10 |
.24 |
|
|
|
License Agreement between Epimmune and Genencor International
Inc. dated July 9, 2001 (with certain confidential portions
deleted).(15)(D) |
|
|
10 |
.25 |
|
|
|
Collaboration Agreement between Epimmune and Genencor
International Inc. dated July 9, 2001 (with certain
confidential portions deleted).(16)(E) |
|
|
10 |
.26 |
|
|
|
Securities Purchase Agreement between Epimmune and Genencor
International Inc. dated July 9, 2001 (with certain
confidential portions deleted).(16)(E) |
|
|
10 |
.27 |
|
|
|
Non-exclusive License Agreement between Epimmune and Biosite
Incorporated dated August 17, 2001 (with certain
confidential portions deleted).(16)(E) |
|
|
10 |
.28 |
|
|
|
Non-exclusive License Agreement between Epimmune and Anosys Inc.
dated August 31, 2001 (with certain confidential portions
deleted).(16)(E) |
|
|
10 |
.29 |
|
|
|
Non-exclusive License Agreement between Epimmune and Bavarian
Nordic A/ S dated November 28, 2001 (with certain
confidential portions deleted).(18)(F) |
|
|
10 |
.30 |
|
|
|
Form of Share Purchase Agreement dated December 18,
2001.(17) |
|
|
10 |
.31 |
|
|
|
2000 Stock Plan as amended.(18)(*) |
|
|
10 |
.32 |
|
|
|
2001 Employee Stock Purchase Plan.(14)(*) |
|
|
10 |
.33 |
|
|
|
Separation Agreement dated October 14, 2002 between
Epimmune and Dr. Sette.(19)(*) |
|
|
10 |
.34 |
|
|
|
Material Transfer Agreement dated October 14, 2002 between
Epimmune and Dr. Sette.(19) |
|
|
10 |
.35 |
|
|
|
First Amendment to the Collaboration Agreement dated
October 16, 2002 between Epimmune and Genencor
International, Inc.(20)(G) |
|
|
10 |
.36 |
|
|
|
First Amendment to the License Agreement dated October 16,
2002 between Epimmune and Genencor International, Inc.(21) |
52
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Document Description |
| |
|
|
|
|
|
|
10 |
.37 |
|
|
|
First Amendment to the Non-Exclusive License Agreement dated
October 18, 2002 between Epimmune and Valentis, Inc.(21)(G) |
|
|
10 |
.38 |
|
|
|
Non-Exclusive License Agreement dated October 28, 2002
between Epimmune and Valentis, Inc.(21)(G) |
|
|
10 |
.39 |
|
|
|
Amendment to Letter Agreement between Epimmune and
Dr. Emile Loria dated June 20, 2003.(22)(*) |
|
|
10 |
.40 |
|
|
|
Non-Exclusive License Agreement between Epimmune and
Immuno-Designed Molecules dated July 7, 2003.(22)(H) |
|
|
10 |
.41 |
|
|
|
Form of Unit Purchase Agreement dated September 18,
2003.(23) |
|
|
10 |
.42 |
|
|
|
Form of Warrant to Purchase Common Stock dated
September 18, 2003.(23) |
|
|
10 |
.43 |
|
|
|
Termination of Amendment to Letter Agreement between Epimmune
and Dr. Emile Loria dated September 8, 2003.(24)(*) |
|
|
10 |
.44 |
|
|
|
Accelerated Benefits Agreement between Epimmune and
Dr. Emile Loria dated February 27, 2004.(25)(*) |
|
|
10 |
.45 |
|
|
|
Unit Purchase Agreement dated April 7, 2004.(26) |
|
|
10 |
.46 |
|
|
|
Unit Purchase Agreement dated April 8, 2004.(26) |
|
|
10 |
.47 |
|
|
|
Forms of Warrants to Purchase Common Stock dated April 7,
2004.(26) |
|
|
10 |
.48 |
|
|
|
Second Amendment to the Collaboration Agreement dated
October 7, 2003 between Epimmune and Genencor
International, Inc.(27) |
|
|
10 |
.49 |
|
|
|
Second Amendment to the License Agreement dated March 14,
2004 between Epimmune and Genencor International, Inc.(27)(I) |
|
|
10 |
.50 |
|
|
|
Third Amendment to the Collaboration Agreement dated
March 16, 2004 between Epimmune and Genencor International,
Inc.(27)(I) |
|
|
10 |
.51 |
|
|
|
Third Amendment to the License Agreement dated March 29,
2004 between Epimmune and Genencor International, Inc.(27)(I) |
|
|
10 |
.52 |
|
|
|
Share Exchange Agreement dated March 15, 2005 between
Epimmune and certain shareholders of Immuno-Designed Molecules,
S.A.(29) |
|
|
10 |
.53 |
|
|
|
Amendment No. 1 dated March 15, 2005 between Epimmune
and the shareholders representative on behalf of certain
shareholders of Immuno-Designed Molecules, S.A.(29) |
|
|
10 |
.54 |
|
|
|
Preferred Exchange Agreement dated March 15, 2005 between
Epimmune and G.D. Searle LLC.(29) |
|
|
10 |
.55 |
|
|
|
Employment Agreement dated March 15, 2005 between Epimmune
and Emile Loria, M.D. (29)(*) |
|
|
10 |
.56 |
|
|
|
Employment Agreement dated March 15, 2005 between Epimmune
and Mark Newman, Ph.D. (29)(*) |
|
|
10 |
.57 |
|
|
|
Employment Agreement dated March 15, 2005 between Epimmune
and Robert De Vaere.(29)(*) |
|
|
14 |
.1 |
|
|
|
Code of Business Conduct and Ethics dated December 9,
2003.(25) |
|
|
21 |
.1 |
|
|
|
Subsidiaries of Epimmune.(J) |
|
|
23 |
.1 |
|
|
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm |
|
|
25 |
.1 |
|
|
|
Power of Attorney. Reference is made to the signature page of
this report |
|
|
31 |
.1 |
|
|
|
Certification of Principal Executive Officer pursuant to
Section 302 of the Public Company Accounting Reform and
Investor Protection Act of 2002 (18 U.S.C.
§ 1350, as adopted) |
|
|
31 |
.2 |
|
|
|
Certification of Principal Financial Officer pursuant to
Section 302 of the Public Company Accounting Reform and
Investor Protection Act of 2002 (18 U.S.C.
§ 1350, as adopted) |
|
|
32 |
.1 |
|
|
|
Certification pursuant to Section 906 of the Public Company
Accounting Reform and Investor Protection Act of 2002
(18 U.S.C. § 1350, as adopted) |
|
|
* |
Executive Compensation Plans and Arrangements |
53
|
|
|
|
(1) |
Incorporated by reference to the Companys Form S-1
Registration Statement and Amendments thereto (File
No. 33-43356). |
|
|
(2) |
Incorporated by reference to the Companys Current Report
on Form 8-K, filed on March 22, 1993. |
|
|
(3) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
1994, filed on March 31, 1995. |
|
|
(4) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended June 30,
1998, filed on August 14, 1998. |
|
|
(5) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended
September 30, 1998, filed on November 16, 1998. |
|
|
(6) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
1998, filed on April 15, 1999. |
|
|
(7) |
Incorporated by reference to the Companys Form 8-K,
filed on July 16, 1999. |
|
|
(8) |
Incorporated by reference to the Companys Definitive Proxy
Statement filed on Form DEF 14A on July 28, 1999. |
|
|
(9) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended
September 30, 1999, filed on November 15, 1999. |
|
|
(10) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
1999, filed on March 17, 2000. |
|
(11) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended June 30,
2000, filed on August 14, 2000. |
|
(12) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
2000, filed on March 29, 2001. |
|
(13) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended March 31,
2001, filed on May 11, 2001. |
|
(14) |
Incorporated by reference to the Companys Form S-8
filed on June 27, 2001 (File No. 333-63950). |
|
(15) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended June 30,
2001, filed on August 13, 2001. |
|
(16) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended
September 30, 2001, filed on November 14, 2001. |
|
(17) |
Incorporated by reference to the Companys Form S-3,
filed on January 10, 2002. |
|
(18) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
2001, filed on March 29, 2002. |
|
(19) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended
September 30, 2002, filed on October 16, 2002. |
|
(20) |
Incorporated by reference to the Companys Registration
Statement on Form S-1, filed on October 24, 2002. |
|
(21) |
Incorporated by reference to Amendment No. 1 to the
Companys Registration Statement on Form S-1/ A, filed
on November 6, 2002. |
|
(22) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended June 30,
2003, filed on August 14, 2003. |
|
(23) |
Incorporated by reference to the Companys Current Report
on Form 8-K, filed on September 19, 2003. |
|
(24) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended
September 30, 2003, filed on November 10, 2003. |
|
(25) |
Incorporated by reference to the Companys Annual Report on
Form 10-K, for the fiscal year ended December 31,
2003, filed on March 30, 2004. |
|
(26) |
Incorporated by reference to the Companys Current Report
on Form 8-K, filed on April 13, 2004. |
54
|
|
(27) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q, for the quarterly period ended March 31,
2004, filed on May 10, 2004. |
|
(28) |
Incorporated by reference to the Companys Registration
Statement on Form S-8, filed with the SEC on July 2,
2004. |
|
(29) |
Incorporated by reference to the Companys Current Report
on Form 8-K, filed on March 18, 2005. |
|
|
|
(A) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on November 21, 1991. |
|
(B) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on May 15, 1996. |
|
(C) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on July 5, 2001. |
|
(D) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on September 4, 2001. |
|
(E) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on January 29, 2002. |
|
(F) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on May 14, 2002. |
|
(G) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on November 5, 2002. |
|
(H) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on October 22, 2003. |
|
(I) |
|
Portions of this exhibit have been granted confidential
treatment pursuant to an order granted by the Securities and
Exchange Commission on September 13, 2004. |
|
(J) |
|
Previously filed. |
55
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, on this 30th day of March 2005.
|
|
|
|
|
Emile Loria, M.D. |
|
President, Chief Executive Officer and Director |
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 |
|
Date |
|
|
|
|
|
|
/s/ Emile Loria
Emile
Loria, M.D. |
|
President
(Principal Executive Officer),
Chief Executive Officer and Director |
|
March 30, 2005 |
|
/s/ Robert J. De Vaere
Robert
J. De Vaere |
|
Vice President, Finance and
Administration
Chief Financial Officer, Secretary
(Principal Financial and
Accounting Officer) |
|
March 30, 2005 |
|
/s/ Howard E.
Greene, Jr.
Howard
E. Greene, Jr. |
|
Chairman of the Board and Director |
|
March 30, 2005 |
|
/s/ William T. Comer
William
T. Comer, Ph.D. |
|
Director |
|
March 30, 2005 |
|
/s/ Michael G. Grey
Michael
G. Grey |
|
Director |
|
March 30, 2005 |
|
/s/ Georges Hibon
Georges
Hibon |
|
Director |
|
March 30, 2005 |
|
John
P. McKearn, Ph.D. |
|
Director |
|
March 30, 2005 |
56
EPIMMUNE INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page | |
|
|
| |
Report of Ernst & Young LLP, Independent Registered
Public Accounting Firm
|
|
|
F-2 |
|
Consolidated Balance Sheets as of December 31, 2004 and 2003
|
|
|
F-3 |
|
Consolidated Statements of Operations for the Years Ended
December 31, 2004, 2003 and 2002
|
|
|
F-4 |
|
Consolidated Statements of Stockholders Equity for the
Years Ended December 31, 2004, 2003, and 2002
|
|
|
F-5 |
|
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2004, 2003 and 2002
|
|
|
F-6 |
|
Notes to Consolidated Financial Statements
|
|
|
F-7 |
|
F-1
REPORT OF ERNST & YOUNG LLP, INDEPENDENT REGISTERED
PUBLIC
ACCOUNTING FIRM
The Board of Directors and Stockholders
Epimmune Inc.
We have audited the accompanying balance sheets of Epimmune Inc.
as of December 31, 2004 and 2003, and the related
statements of operations, stockholders equity and cash
flows for each of the three years in the period ended
December 31, 2004. These financial statements are the
responsibility of the Companys 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 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. We were not engaged to perform an audit
of the Companys internal control over financial reporting.
Our audits 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
Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Epimmune Inc. at December 31, 2004 and 2003, and the
results of its operations and its cash flows for each of the
three years in the period ended December 31, 2004, in
conformity with U.S. generally accepted accounting
principles.
San Diego, California
February 18, 2005
F-2
EPIMMUNE INC.
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
7,006,000 |
|
|
$ |
6,416,000 |
|
|
Accounts Receivable
|
|
|
2,667,000 |
|
|
|
1,012,000 |
|
|
Prepaids and other current assets
|
|
|
221,000 |
|
|
|
186,000 |
|
|
|
|
|
|
|
|
Total current assets
|
|
|
9,894,000 |
|
|
|
7,614,000 |
|
Restricted cash
|
|
|
354,000 |
|
|
|
472,000 |
|
Property and equipment, net
|
|
|
1,032,000 |
|
|
|
1,145,000 |
|
Patents, net
|
|
|
3,527,000 |
|
|
|
3,462,000 |
|
|
|
|
|
|
|
|
|
|
$ |
14,807,000 |
|
|
$ |
12,693,000 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable, trade
|
|
$ |
1,013,000 |
|
|
$ |
290,000 |
|
|
Accrued liabilities
|
|
|
1,700,000 |
|
|
|
1,156,000 |
|
|
Deferred contract revenues
|
|
|
607,000 |
|
|
|
1,151,000 |
|
|
Accrued payroll and related expenses
|
|
|
161,000 |
|
|
|
173,000 |
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
3,481,000 |
|
|
|
2,770,000 |
|
Deferred rent
|
|
|
210,000 |
|
|
|
212,000 |
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 10,000,000 shares
authorized, 1,409,288 shares issued and outstanding at
December 31, 2004 and December 31, 2003. Liquidation
preference of $10,000,000 at December 31, 2004 and
December 31, 2003
|
|
|
14,000 |
|
|
|
14,000 |
|
|
Common stock, $.01 par value, 40,000,000 shares and
25,000,000 shares authorized, 16,011,655 shares and
13,490,618 shares issued and outstanding, respectively, at
December 31, 2004 and December 31, 2003
|
|
|
160,000 |
|
|
|
135,000 |
|
|
Additional paid-in capital
|
|
|
172,933,000 |
|
|
|
167,537,000 |
|
|
Deferred compensation
|
|
|
(184,000 |
) |
|
|
(50,000 |
) |
|
Accumulated deficit
|
|
|
(161,807,000 |
) |
|
|
(157,925,000 |
) |
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
11,116,000 |
|
|
|
9,711,000 |
|
|
|
|
|
|
|
|
|
|
$ |
14,807,000 |
|
|
$ |
12,693,000 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
EPIMMUNE INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research grants and contract revenue
|
|
$ |
7,909,000 |
|
|
$ |
2,521,000 |
|
|
$ |
1,899,000 |
|
|
License fees and milestones
|
|
|
712,000 |
|
|
|
1,118,000 |
|
|
|
487,000 |
|
|
Related party revenue
|
|
|
1,026,000 |
|
|
|
3,519,000 |
|
|
|
4,684,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
9,647,000 |
|
|
|
7,158,000 |
|
|
|
7,070,000 |
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
10,895,000 |
|
|
|
10,495,000 |
|
|
|
11,257,000 |
|
|
General and administrative
|
|
|
2,716,000 |
|
|
|
3,567,000 |
|
|
|
2,887,000 |
|
|
Restructuring costs
|
|
|
|
|
|
|
336,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
13,611,000 |
|
|
|
14,398,000 |
|
|
|
14,144,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,964,000 |
) |
|
|
(7,240,000 |
) |
|
|
(7,074,000 |
) |
|
Interest income, net
|
|
|
89,000 |
|
|
|
191,000 |
|
|
|
587,000 |
|
|
Other (expense) income, net
|
|
|
(7,000 |
) |
|
|
(7,000 |
) |
|
|
(13,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,882,000 |
) |
|
$ |
(7,056,000 |
) |
|
$ |
(6,500,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share-basic and diluted
|
|
$ |
(0.25 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per share-basic and diluted
|
|
|
15,304,928 |
|
|
|
12,238,745 |
|
|
|
11,446,387 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
EPIMMUNE INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
For the three years ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note | |
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
Receivable | |
|
|
|
|
| |
|
| |
|
Paid-in | |
|
from | |
|
Deferred | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Employee | |
|
Compensation | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2001
|
|
|
1,409,288 |
|
|
|
14,000 |
|
|
|
12,094,757 |
|
|
|
121,000 |
|
|
|
166,772,000 |
|
|
|
(2,641,000 |
) |
|
|
(569,000 |
) |
|
Issuance costs related to private placement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,000 |
) |
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
14,764 |
|
|
|
|
|
|
|
4,000 |
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
43,341 |
|
|
|
1,000 |
|
|
|
59,000 |
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with stock bonus award
|
|
|
|
|
|
|
|
|
|
|
600 |
|
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
Interest on note receivable from employee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(291,000 |
) |
|
|
|
|
|
Deferred compensation in connection with the issuance of stock
options to employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(395,000 |
) |
|
|
|
|
|
|
267,000 |
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99,000 |
|
|
Deferred compensation related to consultant stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,000 |
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
1,409,288 |
|
|
$ |
14,000 |
|
|
|
12,153,462 |
|
|
$ |
122,000 |
|
|
$ |
166,454,000 |
|
|
$ |
(2,932,000 |
) |
|
$ |
(203,000 |
) |
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
69,300 |
|
|
|
1,000 |
|
|
|
55,000 |
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
62,635 |
|
|
|
|
|
|
|
61,000 |
|
|
|
|
|
|
|
|
|
|
Issuance of common stock and warrants in connection with private
placement (net)
|
|
|
|
|
|
|
|
|
|
|
2,168,961 |
|
|
|
22,000 |
|
|
|
3,588,000 |
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation related to note on
restricted stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66,000 |
|
|
Interest on note receivable from employee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(123,000 |
) |
|
|
|
|
|
Retirement of common stock in connection with restricted stock
buyback
|
|
|
|
|
|
|
|
|
|
|
(963,740 |
) |
|
|
(10,000 |
) |
|
|
(2,400,000 |
) |
|
|
3,055,000 |
|
|
|
|
|
|
Reversal of deferred compensation related to restricted stock
buyback
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75,000 |
) |
|
|
|
|
|
|
75,000 |
|
|
Deferred compensation related to restricted stock vesting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,000 |
|
|
Net reclass of vested shares from liability to equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(186,000 |
) |
|
|
|
|
|
|
|
|
|
Deferred compensation related to consultant stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,000 |
|
|
|
|
|
|
|
|
|
|
Stock based compensation related to work force reduction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,000 |
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
1,409,288 |
|
|
$ |
14,000 |
|
|
|
13,490,618 |
|
|
$ |
135,000 |
|
|
$ |
167,537,000 |
|
|
$ |
|
|
|
$ |
(50,000 |
) |
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
19,654 |
|
|
|
|
|
|
|
16,000 |
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
35,004 |
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
Issuance of common stock and warrants in connection with private
placement (net)
|
|
|
|
|
|
|
|
|
|
|
2,466,379 |
|
|
|
25,000 |
|
|
|
4,951,000 |
|
|
|
|
|
|
|
|
|
|
Deferred compensation in connection with the issuance of stock
options to employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
253,000 |
|
|
|
|
|
|
|
(253,000 |
) |
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
111,000 |
|
|
Reversal of deferred compensation related to employee stock
options terminated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,000 |
) |
|
|
|
|
|
|
8,000 |
|
|
Net reclass of vested shares from liability to equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
179,000 |
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
1,409,288 |
|
|
$ |
14,000 |
|
|
|
16,011,655 |
|
|
$ |
160,000 |
|
|
$ |
172,933,000 |
|
|
$ |
|
|
|
$ |
(184,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[Additional columns below]
[Continued from above table, first column(s) repeated]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
Other | |
|
Total | |
|
Other | |
|
|
Accumulated | |
|
Comprehensive | |
|
Stockholders | |
|
Comprehensive | |
|
|
Deficit | |
|
Income | |
|
Equity | |
|
Loss | |
|
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2001
|
|
|
(144,369,000 |
) |
|
|
23,000 |
|
|
|
19,351,000 |
|
|
$ |
(2,625,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance costs related to private placement
|
|
|
|
|
|
|
|
|
|
|
(14,000 |
) |
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
4,000 |
|
|
|
|
|
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
|
|
|
Issuance of common stock in connection with stock bonus award
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
Interest on note receivable from employee
|
|
|
|
|
|
|
|
|
|
|
(291,000 |
) |
|
|
|
|
|
Deferred compensation in connection with the issuance of stock
options to employees
|
|
|
|
|
|
|
|
|
|
|
(128,000 |
) |
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
99,000 |
|
|
|
|
|
|
Deferred compensation related to consultant stock options
|
|
|
|
|
|
|
|
|
|
|
27,000 |
|
|
|
|
|
|
Unrealized loss on available-for-sale securities
|
|
|
|
|
|
|
(23,000 |
) |
|
|
(23,000 |
) |
|
|
(23,000 |
) |
|
Net loss
|
|
|
(6,500,000 |
) |
|
|
|
|
|
|
(6,500,000 |
) |
|
|
(6,500,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
$ |
(150,869,000 |
) |
|
$ |
|
|
|
$ |
12,586,000 |
|
|
$ |
(6,523,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
56,000 |
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
61,000 |
|
|
|
|
|
|
Issuance of common stock and warrants in connection with private
placement (net)
|
|
|
|
|
|
|
|
|
|
|
3,610,000 |
|
|
|
|
|
|
Amortization of deferred compensation related to note on
restricted stock
|
|
|
|
|
|
|
|
|
|
|
66,000 |
|
|
|
|
|
|
Interest on note receivable from employee
|
|
|
|
|
|
|
|
|
|
|
(123,000 |
) |
|
|
|
|
|
Retirement of common stock in connection with restricted stock
buyback
|
|
|
|
|
|
|
|
|
|
|
645,000 |
|
|
|
|
|
|
Reversal of deferred compensation related to restricted stock
buyback
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation related to restricted stock vesting
|
|
|
|
|
|
|
|
|
|
|
12,000 |
|
|
|
|
|
|
Net reclass of vested shares from liability to equity
|
|
|
|
|
|
|
|
|
|
|
(186,000 |
) |
|
|
|
|
|
Deferred compensation related to consultant stock options
|
|
|
|
|
|
|
|
|
|
|
34,000 |
|
|
|
|
|
|
Stock based compensation related to work force reduction
|
|
|
|
|
|
|
|
|
|
|
6,000 |
|
|
|
|
|
|
Net loss
|
|
|
(7,056,000 |
) |
|
|
|
|
|
|
(7,056,000 |
) |
|
|
(7,056,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
$ |
(157,925,000 |
) |
|
$ |
|
|
|
$ |
9,711,000 |
|
|
$ |
(7,056,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
16,000 |
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
Issuance of common stock and warrants in connection with private
placement (net)
|
|
|
|
|
|
|
|
|
|
|
4,976,000 |
|
|
|
|
|
|
Deferred compensation in connection with the issuance of stock
options to employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
111,000 |
|
|
|
|
|
|
Reversal of deferred compensation related to employee stock
options terminated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net reclass of vested shares from liability to equity
|
|
|
|
|
|
|
|
|
|
|
179,000 |
|
|
|
|
|
|
Net loss
|
|
|
(3,882,000 |
) |
|
|
|
|
|
|
(3,882,000 |
) |
|
|
(3,882,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
$ |
(161,807,000 |
) |
|
$ |
|
|
|
$ |
11,116,000 |
|
|
$ |
(3,882,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
EPIMMUNE INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,882,000 |
) |
|
$ |
(7,056,000 |
) |
|
$ |
(6,500,000 |
) |
Adjustments to reconcile net loss to net cash (used in) provided
by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
964,000 |
|
|
|
866,000 |
|
|
|
777,000 |
|
|
Stock based compensation
|
|
|
112,000 |
|
|
|
764,000 |
|
|
|
(1,000 |
) |
|
Deferred rent
|
|
|
(2,000 |
) |
|
|
15,000 |
|
|
|
31,000 |
|
|
Write-off of abandoned patents
|
|
|
43,000 |
|
|
|
76,000 |
|
|
|
232,000 |
|
|
Interest on note held by stockholder
|
|
|
|
|
|
|
(123,000 |
) |
|
|
(291,000 |
) |
|
Loss on disposal of assets
|
|
|
|
|
|
|
2,000 |
|
|
|
3,000 |
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(1,655,000 |
) |
|
|
(496,000 |
) |
|
|
(140,000 |
) |
|
|
Prepaids and other current assets
|
|
|
(35,000 |
) |
|
|
6,000 |
|
|
|
139,000 |
|
|
|
Accounts payable, trade
|
|
|
723,000 |
|
|
|
(286,000 |
) |
|
|
125,000 |
|
|
|
Accounts payable and accrued liabilities
|
|
|
722,000 |
|
|
|
210,000 |
|
|
|
(265,000 |
) |
|
|
Deferred revenue
|
|
|
(544,000 |
) |
|
|
37,000 |
|
|
|
(1,194,000 |
) |
|
|
Restricted long-term cash
|
|
|
118,000 |
|
|
|
|
|
|
|
|
|
|
|
Accrued payroll and related expense
|
|
|
(12,000 |
) |
|
|
(79,000 |
) |
|
|
30,000 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(3,448,000 |
) |
|
|
(6,064,000 |
) |
|
|
(7,054,000 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(249,000 |
) |
|
|
(131,000 |
) |
|
|
(735,000 |
) |
Patents
|
|
|
(710,000 |
) |
|
|
(817,000 |
) |
|
|
(1,183,000 |
) |
Purchases of available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
(1,614,000 |
) |
Maturities of available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
12,588,000 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(959,000 |
) |
|
|
(948,000 |
) |
|
|
9,056,000 |
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
4,997,000 |
|
|
|
3,726,000 |
|
|
|
50,000 |
|
Principal payments on notes payable to bank
|
|
|
|
|
|
|
(43,000 |
) |
|
|
(345,000 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
4,997,000 |
|
|
|
3,683,000 |
|
|
|
(295,000 |
) |
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
590,000 |
|
|
|
(3,329,000 |
) |
|
|
1,707,000 |
|
Cash and cash equivalents at beginning of year
|
|
|
6,416,000 |
|
|
|
9,745,000 |
|
|
|
8,038,000 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$ |
7,006,000 |
|
|
$ |
6,416,000 |
|
|
$ |
9,745,000 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
5,000 |
|
|
$ |
5,000 |
|
|
$ |
22,000 |
|
|
|
|
|
|
|
|
|
|
|
Reclassification of unvested common shares from equity to
liabilities
|
|
$ |
|
|
|
$ |
231,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of vested common shares from liabilities to
equity
|
|
$ |
178,000 |
|
|
$ |
46,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing and financing
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (losses) gains on available-for-sale securities
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,000 |
|
|
|
|
|
|
|
|
|
|
|
Return of common stock in connection with restricted stock
buyback
|
|
$ |
|
|
|
$ |
2,410,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2004
|
|
1. |
Summary of Significant Accounting Policies |
|
|
|
Organization and Business Activity |
Epimmune Inc. (the Company) was incorporated in
Delaware on July 10, 1987 as Cytel Corporation. On
July 1, 1999, Cytel merged with its majority-owned
subsidiary, Epimmune Inc., and changed its name from Cytel
Corporation to Epimmune Inc. The Company is focused on the
development of therapeutic and prophylactic vaccines for the
treatment and prevention of infectious diseases and cancer.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. This basis of accounting contemplates the recovery of
the Companys assets and the satisfaction of its
liabilities in the normal course of business. Through
December 31, 2004, the Company has an accumulated deficit
of $161.8 million and is not forecasting profitable
operations in the foreseeable future. Successful completion of
the Companys transition to commercialization and to
attaining profitable operations is dependent upon achieving a
level of revenues adequate to support the Companys cost
structure and, if necessary, obtaining additional financing
and/or reducing expenditures.
In March 2005 the Company agreed to combine its business with
IDM S.A. (Immuno-Designed Molecules), or IDM. If the planned
combination is successful the Company expects to be able to
maintain its current level of operations through 2005, based on
anticipated expenditures. If the planned combination is
unsuccessful, management intends to take the appropriate steps,
including the delay or discontinuation of certain of its
research and development programs and operational activities, to
ensure that the Company will have sufficient funds to support
its operations through at least December 31, 2005. The
Company would also anticipate seeking additional equity
financing if the planned combination with IDM is unsuccessful.
While the Company has been successful in raising equity
financing in the past, there can be no assurance that the
Company will be able to raise additional funds in the future.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and the
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.
|
|
|
Cash and Cash Equivalents |
Cash and cash equivalents consist primarily of cash,
certificates of deposit, treasury securities and repurchase
agreements with original maturities at the date of acquisition
of less than three months.
The Company has classified its investments as available-for-sale
and accordingly carries them at fair value. Unrealized holding
gains or losses on these securities are included in
comprehensive income. The amortized cost of debt securities in
this category is adjusted for amortization of premiums and
accretion of discounts to maturity. Such amortization is
included in interest income. Realized gains and losses are also
included in interest income. The cost of securities sold is
based on the specific-identification method. At
December 31, 2004, the Company had no short-term
investments in its portfolio.
|
|
|
Concentration of Credit Risk |
The Company invests its excess cash in United States government
securities and debt instruments of financial institutions and
corporations with strong credit ratings. The Company has
established guidelines
F-7
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
1. |
Summary of Significant Accounting
Policies (Continued) |
relative to diversification and maturities that maintain safety
and liquidity. These guidelines are periodically reviewed and
modified to take advantage of trends in yields and interest
rates. Management attempts to schedule the maturities of the
Companys investments to coincide with the Companys
expected cash requirements.
At December 31, 2004, approximately 75% of the
Companys accounts receivable balance was from outstanding
grants and contracts with the National Institutes of Health
(NIH). The Company does not believe there is a
significant risk that the outstanding balances will not be
collected.
Property and equipment is stated at cost and depreciation is
computed using the straight-line method over the estimated
useful lives of the assets, which range from three to seven
years. Leasehold improvements are amortized using the
straight-line method over the shorter of the estimated useful
life of the assets or the lease term.
Patent costs are amortized on a straight-line basis over ten
years. The patent costs are shown net of accumulated
amortization of $2,132,000 and $1,553,000 at December 31,
2004 and 2003, respectively.
|
|
|
Impairment of Long-lived Assets |
If indicators of impairment exist, the Company assesses the
recoverability of the affected long-lived assets by determining
whether the carrying value of such assets can be recovered
through undiscounted future operating cash flows. If impairment
is indicated, the Company values the assets at fair value.
|
|
|
Research Grants and Contract Revenue |
Research grants and contract revenue represent research and
development revenues primarily from the National Institutes of
Health and from the Companys collaboration agreement with
Innogenetics N.V. Revenues from grants are recognized on a
percentage-of-completion basis as related costs are incurred.
|
|
|
License Revenues and Expenses |
The Company recognizes revenues pursuant to Staff Accounting
Bulletin No. 104, Revenue Recognition.
Collaboration revenues are earned and recognized as research
costs are incurred in accordance with the provisions of each
agreement. License fees are earned and recognized in accordance
with the provisions of each agreement. Upfront license fees for
perpetual licenses where the Company has no performance
obligations are recognized when received. License fees with
ongoing involvement or performance obligations are recognized
over the term of the agreement. For example, in connection with
the Companys collaboration with Genencor, which has now
been assigned to Innogenetics, because the Company received an
upfront license fee, it is being amortized into revenue over the
collaboration term. Fees paid to initiate research projects are
deferred and recognized over the project period. Milestone
payments are recognized as revenue upon the completion of the
milestone when the milestone event was substantive, its
achievability was not reasonably assured at inception and the
Companys performance obligations after milestone
achievement will continue to be funded at a comparable level
before the milestone achievement. The Company defers revenue
recognition until performance obligations have been completed
and collectibility is reasonably assured.
F-8
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
1. |
Summary of Significant Accounting
Policies (Continued) |
Research and development costs are expensed as incurred.
Expenses under research grants and contracts, which are included
in research and development and for which the Company is
reimbursed, were approximately $8.3 million,
$5.2 million and $5.1 million for 2004, 2003 and 2002,
respectively.
Basic and diluted net loss per common share is presented in
conformity with SFAS No. 128, Earnings per
Share. In accordance with SFAS No. 128, basic and
diluted loss per share has been computed using the weighted
average number of shares outstanding during the period, less
shares subject to repurchase.
The following table presents the calculation of net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss applicable to common stockholders
|
|
$ |
(3,882,000 |
) |
|
$ |
(7,056,000 |
) |
|
$ |
(6,500,000 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing net loss per share,
basic and diluted
|
|
|
15,304,928 |
|
|
|
12,238,745 |
|
|
|
11,446,387 |
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$ |
(0.25 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
The Company has excluded all preferred stock, outstanding stock
options and warrants, and shares subject to repurchase from the
calculation of diluted loss per common share because all such
securities are antidilutive for all periods presented. The total
number of shares excluded from the calculation of diluted net
loss per share, prior to the application of the treasury stock
method for options and warrants, was 6,587,081, 4,572,195, and
4,078,664 for the years ended December 31, 2004, 2003, and
2002, respectively.
|
|
|
Accounting for Stock-based Compensation |
The Company has elected to follow Accounting Principles Board
(APB) Opinion No. 25 Accounting for
Stock Issued to Employees and related interpretations
in accounting for its employee stock options because the
alternative fair value accounting provided for under
SFAS No. 123, Accounting for Stock-Based
Compensation requires use of option valuation models
that were not developed for use in valuing employee stock
options. Under APB Opinion No. 25, because the exercise
price of the Companys employee stock options equals the
market price of the underlying stock on the date of grant, no
compensation expense is recognized.
Deferred compensation for options granted to non-employees has
been determined in accordance with SFAS No. 123 and
Emerging Issues Task Force No. 96-18 as the fair value of
the consideration received or the fair value of the equity
instruments issued, whichever is more reliably measured.
Deferred charges for options granted to non-employees are
periodically re-measured as the underlying options vest.
Adjusted pro forma information regarding net income or loss is
required by SFAS No. 123, and has been determined as
if the Company had accounted for its employee stock options
under the fair-value method of that Statement. The fair value
for these options was estimated at the date of grant using the
Black-Scholes method for option pricing with the
following weighted average assumptions for 2004, 2003, and 2002:
risk-free interest rates of 4%, 4.5% and 6%, respectively;
dividend yield of 0 for all periods; and a weighted average
expected life for all options of six years. The volatility
factor assumptions of the expected market price of the
Companys common stock were 67%, 112%, and 135% for 2004,
2003, and 2002, respectively.
F-9
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
1. |
Summary of Significant Accounting
Policies (Continued) |
For purposes of adjusted pro forma disclosures, the estimated
fair value of the option is amortized to expense over the
options vesting period. The effect of applying
SFAS No. 123 for pro forma information is not likely
to be representative of the effects on pro forma income (loss)
in future years.
The Companys adjusted pro forma information for
December 31, 2004, 2003 and 2002 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss as reported
|
|
$ |
(3,882,000 |
) |
|
$ |
(7,056,000 |
) |
|
$ |
(6,500,000 |
) |
|
Add: stock-based employee compensation expense included in
reported net loss
|
|
|
71,000 |
|
|
|
|
|
|
|
|
|
|
Deduct: total stock-based employee compensation expense
determined under fair value based method for all awards
|
|
|
(1,346,000 |
) |
|
|
(751,000 |
) |
|
|
(758,000 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(5,157,000 |
) |
|
$ |
(7,807,000 |
) |
|
$ |
(7,258,000 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted as reported
|
|
$ |
(0.25 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted pro forma
|
|
$ |
(0.34 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.63 |
) |
|
|
|
|
|
|
|
|
|
|
The Company follows the provisions of SFAS No. 130,
Reporting Comprehensive Income.
SFAS No. 130, which provides rules for the reporting
and display of comprehensive income (loss) and its components.
The Company has disclosed its comprehensive income (loss) in the
statement of stockholders equity.
On September 3, 2003, the Company announced a reduction of
its work force aimed at focusing the Companys efforts on
its most advanced clinical programs and its sponsored and
partnered programs. The Company reduced its research and
administrative staff by 11 individuals or 23%, which resulted in
a one-time restructuring charge of approximately $336,000 in the
third quarter ended September 30, 2003. As of
December 31, 2003, the Company had made payments of
$336,000 related to the work force reduction and no unpaid
balances remained outstanding.
On August 12, 2003, the Company announced that the merger
agreement between the Company and Anosys, Inc., entered into on
May 9, 2003, was terminated. In connection with the
termination of the merger agreement, the Company recorded a
charge of $0.5 million during the second quarter ended
June 30, 2003, which is included in General and
Administrative costs, to write-off costs it had previously
capitalized in connection with the proposed merger.
|
|
|
Recently Issued Accounting Standards |
As permitted by the Financial Accounting Standards Board
Statement No. 123, Accounting for Stock-Based
Compensation, the Company currently accounts for
share-based payments to employees using the Accounting
Principles Board Opinion No. 25, Accounting for
Stock Issued to Employees, the intrinsic value method
and, as such, generally recognizes no compensation cost for
employee stock options. Accordingly, the
F-10
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
1. |
Summary of Significant Accounting
Policies (Continued) |
adoption of Statement 123(R)s fair value method will
have a significant impact on the Companys result of
operations, although it will have no impact on its overall
financial position. The impact of adoption of
Statement 123(R) cannot be predicted at this time because
it will depend on levels of share-based payments granted in the
future. However, had the Company adopted Statement 123(R)
in prior periods, the impact of that standard would have
approximated the impact of Statement 123 as described in
the disclosure of pro forma net income and earnings per share
included elsewhere in this Note 1 to the consolidated
financial statements
|
|
2. |
Short-term Investments |
The Company did not hold any short-term investments at
December 31, 2004 or 2003.
|
|
3. |
Balance Sheet Information |
Prepaids and other current assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Prepaid expenses
|
|
$ |
209,000 |
|
|
$ |
181,000 |
|
Investment interest receivable
|
|
|
12,000 |
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
$ |
221,000 |
|
|
$ |
186,000 |
|
|
|
|
|
|
|
|
Accounts receivable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Billed accounts receivable
|
|
$ |
1,924,000 |
|
|
$ |
456,000 |
|
Unbilled accounts receivable
|
|
|
743,000 |
|
|
|
556,000 |
|
|
|
|
|
|
|
|
|
|
$ |
2,667,000 |
|
|
$ |
1,012,000 |
|
|
|
|
|
|
|
|
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Equipment and furniture
|
|
$ |
2,205,000 |
|
|
$ |
1,960,000 |
|
Leasehold improvements
|
|
|
477,000 |
|
|
|
473,000 |
|
|
|
|
|
|
|
|
|
|
|
2,682,000 |
|
|
|
2,433,000 |
|
Less accumulated depreciation and amortization
|
|
|
(1,650,000 |
) |
|
|
(1,288,000 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,032,000 |
|
|
$ |
1,145,000 |
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2004,
2003 and 2002 was $362,000, $346,000 and $354,000, respectively.
F-11
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
3. |
Balance Sheet Information (Continued) |
Accrued liabilities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Accrued liabilities
|
|
$ |
1,405,000 |
|
|
$ |
923,000 |
|
Directors deferred compensation
|
|
|
295,000 |
|
|
|
233,000 |
|
|
|
|
|
|
|
|
|
|
$ |
1,700,000 |
|
|
$ |
1,156,000 |
|
|
|
|
|
|
|
|
As of December 31, 2004, the Company had 10,000,000
preferred shares authorized and 859,666 shares of
Series S Preferred and 549,622 shares of
Series S-1 Preferred issued and outstanding. The
Series S and Series S-1 Preferred is convertible into
common stock at the option of the holder or will automatically
convert upon the closing of a financing in which the Company
receives gross proceeds of at least $15,000,000. The number of
common shares into which such Series S and Series S-1
Preferred will convert is determined by dividing the original
issue price by the then conversion price. The conversion price
of the Series S Preferred is adjusted for any sales of
securities below the then conversion price while the
Series S-1 Preferred conversion price is fixed. As of
December 31, 2004, the Series S Preferred conversion
price was $5.2875 and the Series S-1 Preferred conversion
price was $7.0958. As of December 31, 2004, the
Series S Preferred would convert into 1,237,950 shares
of common stock and the Series S-1 Preferred would convert
into 549,622 shares of common stock. The Company cannot pay
dividends on any common stock if any of the Series S or
Series S-1 Preferred stock is outstanding unless such
dividend is also paid on the Preferred stock on an as-converted
basis. The Series S and Series S-1 Preferred shares
have a liquidation preference over the common stock of the
Company, which was equal to $10,000,000 at December 31,
2004.
In April 2004, the Company completed a private placement of
2,466,379 shares of common stock and warrants to purchase
up to 1,233,188 shares of common stock to selected
institutional and accredited investors, including current
shareholders, for a total purchase price of $5.5 million.
The Company received net proceeds of $5.0 million. Each
security issued was the combination of one share of common stock
and, for each two shares of common stock purchased, a warrant to
purchase one share of common stock. Each security was priced at
the market value of $2.2125, which was equal to or greater than
the sum of the closing bid price of Epimmune common stock as
quoted on the Nasdaq National Market on the date of execution of
the purchase agreements, and $0.0625, the imputed value of a
warrant to purchase one share of common stock. In addition, the
Company issued warrants to purchase an aggregate of
250,000 shares of its common stock to a placement agent for
services rendered in connection with the private placement. Each
warrant, including the warrant issued to the placement agent,
has a three-year term and an exercise price equal to 120% of
$2.2125 or $2.655 per share.
In September 2003, the Company completed a private placement of
2,168,961 shares of common stock and warrants to purchase
up to 542,238 shares of common stock to selected
institutional and accredited investors, including current
shareholders, for a total purchase price of $4.05 million.
The Company received net proceeds of $3.6 million. The
purchase price of each security, which is the combination of one
share of common stock and a warrant to purchase 25% of one
share of common stock, was priced at the market value of
$1.86725, which was the sum of the average of the closing bid
price of Epimmune common stock as quoted
F-12
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4. |
Stockholders Equity (Continued) |
on the Nasdaq National Market for the five days up to and
including September 17, 2003, and $0.03125, the imputed
value of a warrant to purchase 25% of one share of common
stock. In addition, we issued warrants to purchase an aggregate
of 250,000 shares of our common stock to a placement agent
for services rendered in connection with the private placement.
Each warrant, including the warrant issued to the placement
agent, has a three-year term and an exercise price equal to 125%
of $1.86725 or $2.33406 per share. The Company filed a
registration statement to permit registered resales of the
common stock and the common stock issuable upon exercise of the
warrants sold in the transaction. The registration statement was
declared effective on October 21, 2003.
In May 2000, the Company issued warrants to
purchase 4,960 shares of its common stock with an
exercise price of $1.875 to former officers of Cytel. The
warrants were issued in connection with severance agreements and
were recorded at their fair value on the date of grant. The
expense associated with the issuance of the warrants was
included as part of the restructuring charge. The warrants
issued in May 2000 expired May 2004.
In September 2003, the Company issued warrants to
purchase 542,238 shares of common stock in connection
with its private placement to selected institutional and
accredited investors. Each warrant was priced at $0.03125, the
imputed value of a warrant to purchase 25% of one share of
common stock. In addition, the Company issued warrants to
purchase an aggregate of 250,000 shares of our common stock
to a placement agent for services rendered in connection with
the private placement. Each warrant, including the warrant
issued to the placement agent, has a three-year term and an
exercise price equal to 125% of $1.86725 or $2.33406 per
share.
In April 2004, the Company issued warrants to
purchase 1,233,188 shares of common stock in
connection with its private placement to selected institutional
and accredited investors. Each warrant was priced at $0.0625,
the imputed value of a warrant to purchase 50% of one share
of common stock. In addition, the Company issued warrants to
purchase an aggregate of 250,000 shares of our common stock
to a placement agent for services rendered in connection with
the private placement. Each warrant, including the warrant
issued to the placement agent, has a three-year term and an
exercise price equal to 120% of $2.2125 or $2.655 per share.
|
|
|
Employee Stock Purchase Plan |
In October 1991, the Company adopted an Employee Stock Purchase
Plan (the ESPP) whereby employees, at their option,
could purchase shares of Company common stock through payroll
deductions at the lower of 85% of the fair market value on the
plan offering date or 85% of the fair market value of the common
stock at the purchase date. The ESPP was terminated in July
1999. As of the termination date of the ESPP, 85,558 shares
of common stock had been issued under the Stock Plan.
In March 2001, the Company reserved 300,000 shares of
common stock upon the adoption of the Employee Stock Purchase
Plan (the Purchase Plan) whereby employees, at their
option, could purchase up to 5,000 shares of Epimmune
common stock per offering through payroll deductions at the
lower of 85% of the fair market value on the plan offering date
or 85% of the fair market value of the common stock at the
purchase date. As of December 31, 2004, 160,899 shares
of common stock had been issued under the Purchase Plan.
F-13
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4. |
Stockholders Equity (Continued) |
|
|
|
Directors Deferred Compensation Plan |
Under the Directors Deferred Compensation Plan,
participating directors may elect on an annual basis, to defer
all of their cash compensation, for service on the
Companys Board, in a deferred compensation account
pursuant to which the deferred fees are credited in the form of
share units having a value equal to shares of the Companys
common stock (Share Units), based on the market
price of the stock at the time the deferred fees are earned. The
Company will continue to credit Share Units to the
participants deferred compensation accounts on a quarterly
basis. When a participant ceases serving as a director, the
participant shall be entitled to receive the value of his or her
account either in a single lump-sum payment or in equal annual
installments, as determined by the Company in its sole
discretion. No participant entitled to receive a payment of
benefits shall receive payment in the form of the Companys
common stock. For the years ended December 31, 2004, 2003
and 2002 the Company recorded an (expense) benefit of
($62,000), ($169,000) and $68,000, respectively, related to the
Directors Deferred Compensation Plan.
In November 1989, the Company adopted a Stock Plan (the
1989 Plan), under which options may be granted to
employees, directors, consultants or advisors. The 1989 Plan
provided for the grant of both incentive stock options and
nonstatutory stock options. The exercise price of an incentive
stock option is not less than the fair market value of the
common stock on the date of grant. The exercise price of
nonstatutory options is not less than 85% of the fair market
value of the common stock on the date of grant. No options
granted under the 1989 Plan have a term in excess of ten years
from the date of grant. Shares and options issued under the 1989
Plan vest over varying periods of one to six years. Effective
June 9, 2000 with the approval of the Companys 2000
Plan, the 1989 Plan was discontinued resulting in cancellation
of remaining available shares, and any shares granted under the
1989 Plan that in the future are cancelled or expire will not be
available for re-grant. As of December 31, 2004, options to
purchase 226,938 shares of common stock were
outstanding under the 1989 Plan.
In December 1997, the Company adopted a Stock Plan (the
1997 Plan), under which options were granted to
employees, directors, and consultants of the Company. The 1997
Plan provided for the grant of both incentive stock options and
nonstatutory stock options. The exercise price of an incentive
stock option was not less than the fair market value of the
common stock on the date of grant. The exercise price of
nonstatutory options was not less than 85% of the fair market
value of the common stock on the date of grant. No options
granted under the 1997 Plan have a term in excess of ten years
from the date of grant. Options issued under the 1997 Plan vest
over varying periods of one to four years. Options that
terminate will not be available for future grant. As of
December 31, 2004, options to
purchase 119,209 shares of common stock were
outstanding under the 1997 Plan.
In June 2000, the Company adopted a Stock Plan (the 2000
Stock Plan), and reserved 700,000 shares for issuance
under the plan. Options under the plan may be granted to
employees, directors, consultants or advisors of the Company.
The 2000 Stock Plan provides for the grant of both incentive
stock options and nonstatutory stock options. The exercise price
of an incentive stock option is not less than the fair market
value of the common stock on the date of the grant. The exercise
price of nonstatutory options is also not less than the fair
market value of the common stock on the date of grant. No
options granted under the 2000 Stock Plan
F-14
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4. |
Stockholders Equity (Continued) |
have a term in excess of ten years from the date of grant.
Options issued under the 2000 Stock Plan may vest over varying
periods of up to four years.
In December 2001, the Board amended, and the Epimmune
stockholders subsequently approved, the 2000 Plan to include a
500,000 increase in the number of shares reserved for issuance
under the 2000 Stock Plan to a total of one million two hundred
thousand (1,200,000) shares. On December 16, 2002, the
Company granted stock bonus awards of 600 shares to its
executive officers from the 2000 Plan. In June 2003, the Board
amended, and the Epimmune stockholders subsequently approved,
the 2000 Plan to include a 400,000 increase in the number of
shares reserved for issuance under the 2000 Stock Plan to a
total of one million six hundred thousand (1,600,000) shares. In
December 2003, the Board amended, and the Epimmune stockholders
subsequently approved, the 2000 Plan to include a 1,000,000
increase in the number of shares reserved for issuance under the
plan to a total of two million six hundred thousand (2,600,000)
shares. As of December 31, 2004, options to
purchase 2,175,000 shares of common stock were
outstanding and 399,393 shares were available for future
grant under the 2000 Stock Plan.
The following table summarizes stock option activity under all
stock option plans for the three years ended December 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
Shares | |
|
Average Price | |
|
|
| |
|
| |
Balance at December 31, 2001
|
|
|
1,539,614 |
|
|
$ |
4.07 |
|
|
Granted
|
|
|
194,520 |
|
|
$ |
2.03 |
|
|
Exercised
|
|
|
(15,364 |
) |
|
$ |
0.28 |
|
|
Cancelled
|
|
|
(33,874 |
) |
|
$ |
4.74 |
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
1,684,896 |
|
|
$ |
3.86 |
|
|
Granted
|
|
|
851,000 |
|
|
$ |
1.57 |
|
|
Exercised
|
|
|
(62,635 |
) |
|
$ |
0.97 |
|
|
Cancelled
|
|
|
(475,809 |
) |
|
$ |
5.47 |
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
1,997,452 |
|
|
$ |
2.59 |
|
|
Granted
|
|
|
1,147,000 |
|
|
$ |
1.57 |
|
|
Exercised
|
|
|
(35,004 |
) |
|
$ |
0.16 |
|
|
Cancelled
|
|
|
(588,301 |
) |
|
$ |
3.01 |
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
2,521,147 |
|
|
$ |
2.06 |
|
|
|
|
|
|
|
|
F-15
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4. |
Stockholders Equity (Continued) |
The following is a summary of the options outstanding under all
of the Companys stock option plans as of December 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
Weighted | |
|
|
|
|
|
Average | |
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Exercise Price | |
|
|
Options | |
|
Remaining Life | |
|
Average | |
|
Options | |
|
of Options | |
Range of Exercise Prices |
|
Outstanding | |
|
in Years | |
|
Exercise Price | |
|
Exercisable | |
|
Exercisable | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 0.16
|
|
|
31,720 |
|
|
|
2.96 |
|
|
$ |
0.16 |
|
|
|
31,720 |
|
|
$ |
0.16 |
|
$ 0.48
|
|
|
87,489 |
|
|
|
3.99 |
|
|
|
0.48 |
|
|
|
87,489 |
|
|
|
0.48 |
|
$ 1.26 - $ 3.37
|
|
|
2,211,502 |
|
|
|
8.39 |
|
|
|
1.79 |
|
|
|
1,196,440 |
|
|
|
1.99 |
|
$ 3.75 - $ 6.00
|
|
|
174,000 |
|
|
|
5.11 |
|
|
|
5.02 |
|
|
|
174,000 |
|
|
|
5.02 |
|
$10.50 - $16.25
|
|
|
10,500 |
|
|
|
3.80 |
|
|
|
12.01 |
|
|
|
10,500 |
|
|
|
12.01 |
|
$21.87 - $42.88
|
|
|
5,936 |
|
|
|
0.98 |
|
|
|
30.68 |
|
|
|
5,936 |
|
|
|
30.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
2,521,147 |
|
|
|
|
|
|
|
|
|
|
|
1,506,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted averages
|
|
|
|
|
|
|
7.91 |
|
|
$ |
2.06 |
|
|
|
|
|
|
$ |
2.39 |
|
The weighted average fair value of options granted during 2004,
2003 and 2002 was $1.24, $1.51 and $1.87, respectively.
On January 16, 2001, the Company entered into an employment
agreement with Dr. Emile Loria for the position of
President and Chief Executive Officer. Dr. Loria was
elected to the Companys Board of Directors. Also on
January 16, 2001, the Company entered into a Restricted
Stock Purchase agreement with Dr. Loria for the purchase of
1,056,301 common shares at $2.50 per share. The shares
vested daily over a four-year period and unvested shares were
subject to a repurchase option in favor of the Company. A
promissory note with an interest rate of 5.61% was issued for
the purchase price of the shares. In September 2003,
Dr. Loria surrendered an aggregate of 963,740 shares
of the Companys common stock at the fair market value of
$3.17 per share, in exchange for the prepayment of the
outstanding principal and interest under the promissory note, a
total of $3,055,000. At the time of the transaction, the Company
included $231,000 associated with the remaining 92,561 unvested
shares in accrued liabilities as the Company has a repurchase
option on the unvested shares at the original exercise price. As
the remaining 92,561 unvested shares vest between
September 29, 2003 and January 15, 2005, the liability
was reclassed into equity in equal installments. At
December 31, 2004, 2,936 shares were unvested and
subject to the repurchase option.
In connection with the prepayment of the note, the Company
recorded a non-cash, stock-based compensation charge of
approximately $645,000 in the third quarter of 2003 based on the
difference between the fair market price on September 29,
2003 and the exercise price of the shares surrendered by
Dr. Loria. The Company also accrued an additional $62,000
in non-cash, stock-based compensation charges associated with
the 92,561 remaining unvested shares, which it amortized to
expense as the unvested shares vested between September 29,
2003 and January 15, 2005. The Company had $2,000 and
$50,000 of accrued deferred compensation at December 31,
2004 and 2003, respectively, related to the unvested shares.
Prior to the prepayment of the promissory note, the Company
recorded monthly compensation expense related to the shares sold
to Dr. Loria based on the provisions of EITF 95-16,
Accounting for Stock Compensation Arrangements with
Employer Loan features under APB 25. For the
years ended December 31, 2003 and 2002, the Company
recorded a charge of $66,000 and a benefit of $127,000 of
compensation expense, respectively.
The Company also recorded compensation expense related to the
below market interest rate the promissory note bore. For the
years ended December 31, 2003 and 2002, the Company
recorded $66,000 and $99,000 of compensation expense related to
the note, respectively.
F-16
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4. |
Stockholders Equity (Continued) |
On December 26, 2003, the Board granted options to
purchase 1,078,000 shares of the Companys common
stock, 1,000,000 of which were contingent upon
shareholders approval of a 1,000,000 share increase
in the number of shares reserved for issuance under the 2000
Stock Plan. The Companys shareholders subsequently
approved the share increase on June 15, 2004. At that time,
the Company recorded a non-cash stock-based compensation charge
of $32,000, related to the December 2003 option grants, and
accrued an additional $220,000 in deferred compensation charges,
which will be amortized into expense as the options vest. The
deferred compensation charges were based on the difference
between the grant price of the options on December 26, 2003
and the closing price of the Companys common stock on
June 15, 2004, the date the shareholders approved the
increase in the option pool. The Company had $182,000 of accrued
deferred compensation at December 31, 2004, related to the
unvested options.
|
|
|
Shares Reserved for Future Issuance |
The following shares of common stock are reserved for future
issuance at December 31, 2004:
|
|
|
|
|
Options granted and outstanding
|
|
|
2,521,147 |
|
Options authorized for future grants
|
|
|
399,393 |
|
Employee stock purchase plan for future purchases
|
|
|
139,101 |
|
Stock warrants
|
|
|
2,275,426 |
|
Conversion of preferred stock
|
|
|
1,787,572 |
|
|
|
|
|
|
|
|
7,122,639 |
|
|
|
|
|
The Company leases its office and research facility under an
operating lease that expires in March 2009. Under this operating
lease, the Company pays taxes, insurance and maintenance
expenses related to the premises. Epimmunes facility lease
requires a letter of credit of $354,000 to secure the
performance of the Companys lease obligation and is
reflected as restricted cash. Rent expense was $582,000 for each
of the years ended December 31, 2004, 2003 and 2002.
Future minimum lease payments under operating leases at
December 31, 2004 are as follows:
|
|
|
|
|
|
|
Operating | |
Year |
|
Leases | |
|
|
| |
2005
|
|
$ |
602,000 |
|
2006
|
|
|
620,000 |
|
2007
|
|
|
639,000 |
|
2008
|
|
|
658,000 |
|
2009
|
|
|
166,000 |
|
|
|
|
|
Total minimum lease payments
|
|
$ |
2,685,000 |
|
|
|
|
|
|
|
6. |
Revenues Under Collaborative Research and Development
Agreements |
|
|
|
National Institutes of Health |
In May 2004, the Company received a grant from the National
Cancer Institute (NCI), an institute of the NIH, to
support its continuing and detailed analysis of the immune
responsiveness of patients immunized with the Companys
multi-epitope cancer vaccine candidate, EP-2101. The Company is
currently conducting
F-17
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Revenues Under Collaborative Research and Development
Agreements (Continued) |
two Phase I/ II trials with its EP-2101 vaccine, one in
colorectal cancer and one in non-small cell lung
(NSCL) cancer, at various sites in the U.S. The
grant has a total potential value of approximately
$0.8 million over two years. The Company is recognizing
revenue under the grant as reimbursable expenses under the grant
are incurred.
In March 2004, the Company received a grant from the NCI to
define and conduct preclinical testing of a multi-epitope,
clinical vaccine candidate for ovarian and breast cancer. The
Company is collaborating with investigators at the University of
Washington on the program with an objective of designing a
vaccine to induce helper T cell (HTL) responses
directed against multiple tumor associated antigens
(TAA), in order to prevent or delay disease
recurrence after surgery and chemotherapy. The Phase I
grant has a total potential value of approximately
$0.6 million over two years. From the Phase I program,
it is contemplated that a multi-epitope based vaccine will be
designated for development and clinical testing in a potential
Phase II program. The Company is recognizing revenue under
the grant as reimbursable expenses under the grant are incurred.
In September 2003, the Company received a five-year,
$16.7 million contract from the National Institute of
Allergy and Infectious Diseases (NIAID), an
institute of the NIH, for the design and development of
prophylactic HIV vaccines for clinical evaluation. The Company
is recognizing revenue under the contract as reimbursable
expenses under the contract are incurred.
In July 2003, the Company received a grant from the NCI to
support continued epitope analog identification and preclinical
development of multi-epitope, analog based cancer vaccines. The
grant has a total potential value of approximately
$0.6 million over two years. The activities funded by this
grant complement current studies and Phase I/ II clinical
trials the Company is conducting by providing analog epitopes
that extend vaccine coverage to larger segments of the
population. The grant was made under the NCIs Flexible
System to Advance Innovative Research for Cancer Drug Discovery
by Small Business, or FLAIR program. The Company is recognizing
revenue under the grant as reimbursable expenses under the grant
are incurred.
In October 2002, the Company was awarded a contract from the
NIAID to conduct research and development aimed at developing a
malaria vaccine. The award is part of the NIAIDs
Millennium Vaccine Initiative that solicits vaccine technology
from the private sector to accelerate the development of
effective vaccines for malaria and tuberculosis. The program is
composed of a $0.7 million Phase A feasibility study and an
option for a $2.8 million Phase B development program for a
total potential value of $3.5 million over five years. The
Company is working with investigators at the Naval Medical
Research Center on the program. In July 2004, the Company
received written notice from the NIH exercising the three-year
Phase B option for Epimmune to conduct preclinical development
of a multi-epitope malaria vaccine. The NIH decision followed
the Company meeting predetermined Phase A criteria in which it
demonstrated the preclinical feasibility of a vaccine that would
target malaria in all human ethnicities. The Phase B preclinical
development program objective is design of a vaccine candidate
suitable for human testing. The Company is recognizing revenue
under the contract as reimbursable expenses under the contract
are incurred.
In September 2003, the Company entered into an agreement with
Amgen Inc. under which Amgen acquired a non-exclusive license to
Epimmunes PADRE® technology for research use. Under
the terms of the agreement, Epimmune received a license fee that
will be amortized into revenue over the term of the agreement.
F-18
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Revenues Under Collaborative Research and Development
Agreements (Continued) |
In April 2003, the Company entered into an agreement with
Merck & Co., Inc. under which Merck will evaluate
select Epimmune epitopes in connection with technology
controlled by Merck for the development of certain vaccines.
Under the terms of the agreement, the Company provided Merck a
limited number of its proprietary analog, or modified, epitopes,
which will then be evaluated in connection with delivery
technologies owned or controlled by Merck to determine the
activity of the Epimmune epitopes. The Company received an
evaluation license fee in connection with the agreement, which
is being amortized into revenue over the term of the agreement.
Merck has an option to enter into licensing discussions with the
Company for the development of the Epimmune epitopes for use in
vaccines for the treatment of certain diseases.
In January 2003, the Company entered into an option and license
agreement with Beckman Coulter, Inc. under which Beckman Coulter
could acquire a non-exclusive, worldwide license to certain
Epimmune epitopes on an epitope-by-epitope basis for certain
infectious diseases and cancer indications. Beckman Coulter
could use these epitopes for research and diagnostic
applications in connection with their MHC Tetramer and other
immune response monitoring technologies. Under the terms of the
agreement, the Company was entitled to annual option fees, which
were amortized into revenue over the term of the agreement. In
the event that Beckman Coulter exercised its option to acquire a
license to any specific epitope, the Company was entitled to
additional license fees for each epitope and royalties on
product sales in the event any products were commercialized
using the Companys technology. In January 2005, Beckman
Coulter chose not to exercise its option rights under the
agreement.
|
|
|
Immuno-Designed Molecules, S.A. |
In October 2002, the Company entered into an evaluation and
license option agreement with Immuno-Designed Molecules, S.A.,
or IDM, for certain cancer antigens for use in IDMs ex
vivo cancer therapy program. Under the terms of the
agreement, IDM had 120 days from the date of the option
agreement to evaluate the epitopes and exercise its option to
license certain patented and non-patented rights to
Epimmunes universal cancer epitope packages for use in
ex vivo cancer therapy. In February 2003, IDM exercised
its option and now has a non-exclusive license to use the
epitopes in connection with its
Dendritophagetm
ex vivo technology. The Company received an evaluation
license fee when it entered into the evaluation, which is being
amortized into revenue over the evaluation period. The Company
also received a license fee when IDM exercised its option. The
parties have now negotiated and entered into a license agreement
and the Company may be entitled to receive commercialization
milestone payments and royalties on product sales if IDM
develops products using Epimmunes technology.
In July 2002, the Company entered into an evaluation and license
option agreement with Aventis Pasteur Limited, which gave
Aventis, for twelve months, the right to exercise its option to
license from Epimmune certain epitopes from two cancer
associated antigens. Aventis will evaluate the epitopes for
possible integration into its pox virus therapeutic cancer
vaccine program. The Company received an evaluation license fee,
which was amortized into revenue over the evaluation period. In
June 2003, the end of the evaluation period, Aventis Pastuer
chose not to exercise its rights under the agreement.
F-19
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Revenues Under Collaborative Research and Development
Agreements (Continued) |
In November 2001, the Company entered into a collaboration
agreement with Bavarian Nordic A/ S to combine its technology
and expertise in the fields of T cell epitope identification and
vaccine design with Bavarian Nordics vaccine delivery
technology and manufacturing expertise to develop vaccines for
the treatment or prevention of HIV infection. The Company did
not record revenue on Bavarian Nordic for the years ended
December 31, 2004 and 2003.
In August 2001, the Company entered into a license agreement
with Anosys Inc., formerly AP Cells, granting Anosys a
non-exclusive license to certain cancer antigens and associated
technology for use in ex vivo cell therapy. In connection
with the agreement, the Company received an upfront license fee,
which was recognized as revenue during 2001, as the Company had
no on-going obligations. The Company is also entitled to receive
milestones and royalties on product sales, if any products are
ever developed. In September 2003, the Company announced it had
received a milestone payment under the agreement as a result of
Anosys filing an IND for a product incorporating technology
licensed to them. In addition, the Company announced that it had
received payment of additional license fees under the terms of
the original agreement as a result of Epimmune regaining all
rights to the technology covered by the agreement in Japan. Both
the milestone payment and the additional license fees were
recognized as revenue in the third quarter ended
September 30, 2003. In the event Anosys elects to exercise
its rights to include Japan in the territory covered by the
agreement, Epimmune will be entitled to an additional license
fee payment.
|
|
|
Genencor International, Inc. |
In July 2001, the Company entered into a collaboration with
Genencor International, Inc. for vaccines to treat or prevent
hepatitis B virus, hepatitis C virus and human papilloma
virus. Pursuant to the agreement, Epimmune exclusively licensed
to Genencor its PADRE® and epitope technologies for
vaccines to treat or prevent hepatitis B, hepatitis C and
human papilloma virus. In connection with this collaboration,
the Company received an upfront license fee, which is being
amortized over the collaboration term. In addition, Genencor
made an initial ten percent equity investment in Epimmune common
stock at a premium to the market price. Under the agreement, the
Company may receive a total of approximately $60 million in
payments, including the initial equity investment but excluding
royalties. In January 2002, Epimmune received a payment from
Genencor for achievement of the first milestone, identification
of a product candidate to treat chronic hepatitis B infection.
In February 2004, the Company announced it had earned a
milestone payment from Genencor as a result of Genencor filing
an IND for a vaccine to treat Hepatitis B. The milestone
payments were recognized as revenue when received. The
collaboration revenues are being recognized as incurred. In
addition, Genencor fully funded Epimmunes research in
these specific indications and was obligated to pay the Company
royalties on sales of any products that may have been developed
under the collaboration. The initial collaboration had a term
through September 2003, and in October 2002, was extended to
September 2004. In March 2004, Genencor assigned its rights
under the collaboration to Innogenetics NV. In connection with
the assignment by Genencor, the Company extended the
collaboration term with Innogenetics through September 2005. In
addition, Genencor agreed not to sell or otherwise dispose of
any of the Companys common stock it held, without the
Companys prior approval, for a minimum of twelve months.
Innogenetics has the right to terminate the collaboration early,
upon three months written notice, if Epimmune breaches its
obligations under the collaboration agreement or upon certain
force majeure events. All revenues from Genencor are included in
related party revenue.
F-20
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Revenues Under Collaborative Research and Development
Agreements (Continued) |
In June 2001, the Company entered into a license agreement with
Pharmexa A/ S granting Pharmexa a non-exclusive license to the
Companys PADRE® technology for use in connection with
Pharmexas
AutoVactm
technology for controlling autoimmune diseases. In connection
with the agreement, the Company received an upfront license fee
and is also entitled to receive milestones and royalties on
product sales, if any products are ever developed. The upfront
license fee was recognized as revenue during 2001 as the Company
had no on-going obligations. In December 2004, the Company and
Pharmexa amended the license agreement to include additional
target antigens. The Company received an additional up-front
license fee, which was recognized as revenue in December 2004.
Significant components of the Companys deferred tax assets
as of December 31, 2004 and 2003 are shown below. A
valuation allowance of $65,692,000 at December 31, 2004 and
$65,668,000 at December 31, 2003 has been recognized to
offset the deferred tax assets as realization of such assets is
uncertain.
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Patents expensed for tax
|
|
$ |
(1,212,000 |
) |
|
$ |
(1,162,000 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities
|
|
|
(1,212,000 |
) |
|
|
(1,162,000 |
) |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Capitalized research expenses
|
|
|
1,752,000 |
|
|
|
1,476,000 |
|
|
Net operating loss carryforwards
|
|
|
55,083,000 |
|
|
|
55,167,000 |
|
|
Research and development credits
|
|
|
9,654,000 |
|
|
|
9,698,000 |
|
|
Other, net
|
|
|
415,000 |
|
|
|
489,000 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
66,904,000 |
|
|
|
66,830,000 |
|
Valuation allowance for deferred tax assets
|
|
|
(65,692,000 |
) |
|
|
(65,668,000 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
At December 31, 2004, the Company has federal and
California net operating loss carryforwards of approximately
$147,077,000 and $88,352,000, respectively. The difference
between the federal and California tax loss carryforwards is
primarily attributable to the capitalization of research and
development expenses for California tax purposes and expiration
of the California tax loss carryforwards. The federal tax loss
carryforwards began to expire in 2004 and will continue to do so
until 2024, unless previously utilized. The California tax loss
carryforwards will continue to expire until 2014. The Company
also has federal and California research and development tax
credit carryforwards of $7,416,000 and $3,443,000, respectively.
The federal research and development tax credit carryforwards
began to expire in 2004 and will continue to do so in 2005,
unless previously utilized. The California research and
development tax credit carryforwards do not expire and will
carry forward indefinitely until utilized. Pursuant to Internal
Revenue Code Sections 382 and 383, the annual use of the
Companys net operating loss and credit carryforwards will
be limited because of greater than 50% cumulative changes in
ownership, which occurred during 1989 and 1994. However, the
Company believes that these limitations will not have a material
impact on the financial statements.
F-21
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company has a defined contribution plan, the Epimmune Inc.
401(k) Plan, which covers all full-time employees of the
Company. This plan allows each eligible employee to voluntarily
make pre-tax deferred salary contributions. The Company may make
contributions in amounts as determined by the Board of
Directors. The Company did not make any matching contributions
for the years ended December 31, 2004, 2003 and 2002.
|
|
9. |
Unaudited Quarterly Financial Information |
The following tables present unaudited quarterly financial
information, for the eight quarters ended December 31,
2004. We believe this information reflects all adjustments
(consisting only of normal recurring adjustments) that we
consider necessary for a fair presentation of such information
in accordance with accounting principles generally accepted in
the United States. The results for any quarter are not
necessarily indicative of results for any future period (in
millions, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1st Quarter | |
|
2nd Quarter | |
|
3rd Quarter | |
|
4th Quarter | |
|
|
| |
|
| |
|
| |
|
| |
Year Ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
2.6 |
|
|
$ |
1.9 |
|
|
$ |
2.1 |
|
|
$ |
3.0 |
|
|
Loss from operations
|
|
|
(0.5 |
) |
|
|
(0.9 |
) |
|
|
(1.0 |
) |
|
|
(1.6 |
) |
|
Net loss
|
|
|
(0.5 |
) |
|
|
(0.9 |
) |
|
|
(0.9 |
) |
|
|
(1.6 |
) |
|
Basic and diluted net loss per share(a)
|
|
|
(0.04 |
) |
|
|
(0.06 |
) |
|
|
(0.06 |
) |
|
|
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1st Quarter | |
|
2nd Quarter | |
|
3rd Quarter | |
|
4th Quarter | |
|
|
| |
|
| |
|
| |
|
| |
Year Ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
1.4 |
|
|
$ |
1.8 |
|
|
$ |
2.0 |
|
|
$ |
1.9 |
|
|
Loss from operations
|
|
|
(1.9 |
) |
|
|
(2.1 |
) |
|
|
(2.1 |
) |
|
|
(1.2 |
) |
|
Net loss
|
|
|
(1.8 |
) |
|
|
(2.0 |
) |
|
|
(2.0 |
) |
|
|
(1.2 |
) |
|
Basic and diluted net loss per share
|
|
|
(0.15 |
) |
|
|
(0.17 |
) |
|
|
(0.17 |
) |
|
|
(0.09 |
) |
|
|
(a) |
The sum of the four quarters will not agree to year total due to
rounding within the quarter. |
|
|
10. |
Subsequent Events (Unaudited) |
On March 16, 2005, the Company announced that it had agreed
to combine its business with IDM S.A. (Immuno-Designed
Molecules), or IDM, a privately held company based in France,
pursuant to a Share Exchange Agreement. The all-stock
transaction has been unanimously approved by the boards of
directors of both companies. In addition, certain institutional
investors, strategic partners and executives of IDM, who
collectively hold more than 85% of IDMs outstanding stock
(including shares issuable upon exercise of warrants), have
entered into the Share Exchange Agreement thus far. The closing
of the transaction is subject to certain closing conditions
including approval by Epimmunes shareholders. Upon closing
of the transaction, the combined company will be named IDM, Inc.
and its shares are expected to be traded on the Nasdaq National
Market under the ticker IDMI. The combined company will focus on
immunotherapeutic products for cancer and selected infectious
diseases.
Pursuant to the Share Exchange Agreement, the Company would
acquire all of the outstanding share capital of IDM, with
certain exceptions related to shares and a warrant held in
French share savings plans, in exchange for shares of Epimmune
common stock, and IDM would become a subsidiary of the Company.
Each share of IDM would be exchanged for approximately
3.771865 shares of Epimmune common stock, and the former
shareholders of IDM will hold, in aggregate, approximately 78%
of the Companys outstanding
F-22
EPIMMUNE INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
10. |
Subsequent Events (Continued) |
common stock, on a fully diluted basis, immediately following
the closing of the transaction. In connection with the
transaction, the Companys outstanding Series S and
Series S-1 preferred stock would be exchanged for a total
of 1,949,278 shares of the Companys common stock. The
Share Exchange Agreement also sets forth the terms for treatment
of outstanding options and warrants to purchase IDM shares
in the transaction.
Subsequent to the transaction, IDM would effectively control
Epimmune. As a result, if approved and completed, the
transaction will be accounted for as a reverse acquisition,
whereby for financial reporting purposes, IDM is considered the
acquiring company. Hence, the historical financial statements of
IDM would become the historical financial statements of the
Company and include the results of operations of Epimmune only
from the acquisition date forward.
The shares the Company would issue in the exchange would not be
registered under U.S. securities laws and may not be
offered or sold in the U.S. absent registration or unless
an applicable exemption from the registration requirements is
available. The Company would file a registration statement
covering the resale of the shares issued in the transaction
following the closing of the transaction.
The Company would issue common stock equal to more than 20% of
its outstanding voting shares pursuant to the Share Exchange
Agreement and would therefore have to obtain shareholder
approval of the transaction per Nasdaq rules. The Company will
file a proxy statement and hold a meeting of its shareholders to
approve the Share Exchange Agreement and certain related actions
including changing its name to IDM, Inc.
F-23