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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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(Mark One) |
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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 |
Commission File No. 0-15327
CytRx Corporation
(Exact name of Registrant as specified in its charter)
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Delaware
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58-1642740 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
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11726 San Vicente Blvd, Suite 650,
Los Angeles, California
(Address of principal executive offices) |
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90049
(Zip Code) |
Registrants telephone number, including area code:
(310) 826-5648
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $.001 par value per share
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 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 is not
contained herein, and will not be contained, to the best of the
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
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Indicate by check mark with the Registrant is an accelerated
filer (as defined in Exchange Act
Rule 12b-2). Yes o No þ
The aggregate market value of the Registrants common stock
held by non-affiliates on June 30, 2004 was approximately
$33,288,000. On March 28, 2005, there were
57,413,449 shares of the Registrants common stock
outstanding, exclusive of treasury shares.
CYTRX CORPORATION
2004 FORM 10-K ANNUAL REPORT
TABLE OF CONTENTS
Exhibit Index located on page 56 of this report.
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SAFE HARBOR STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
From time to time, we make oral and written statements that may
constitute forward-looking statements (rather than
historical facts) as defined in the Private Securities
Litigation Reform Act of 1995 or by the Securities and Exchange
Commission (the SEC) in its rules, regulations and
releases, including Section 27A of the Securities Act of
1933, as amended (the Securities Act) and Section 21E of
the Securities Exchange Act of 1934, as amended. We desire to
take advantage of the safe harbor provisions in the
Private Securities Litigation Reform Act of 1995 for
forward-looking statements made from time to time, including,
but not limited to, the forward-looking statements made in this
Annual Report on Form 10-K (the Annual Report),
as well as those made in other filings with the SEC.
All statements in this Annual Report, including in
Managements Discussion and Analysis of Financial
Condition and Results of Operations, other than statements
of historical fact are forward-looking statements for purposes
of these provisions, including any projections of financial
items, any statements of the plans and objectives of management
for future operations, any statements concerning proposed new
products or services, any statements regarding future economic
conditions or performance, and any statement of assumptions
underlying any of the foregoing. In some cases, forward-looking
statements can be identified by the use of terminology such as
may, will, expects,
plans, anticipates,
estimates, potential or
could or the negative thereof or other comparable
terminology. Although we believe that the expectations reflected
in the forward-looking statements contained herein and in
documents incorporated by this Annual Report are reasonable,
there can be no assurance that such expectations or any of the
forward-looking statements will prove to be correct, and actual
results could differ materially from those projected or assumed
in the forward-looking statements.
Our future financial condition and results of operations, as
well as any forward-looking statements, are subject to inherent
risks and uncertainties, including but not limited to the risk
factors set forth in under the heading Risk Factors
in this Annual Report, and including risks or uncertainties
related to the early stage of our diabetes, obesity, CMV and ALS
research, the need for future clinical testing of any small
molecules and products based on ribonucleic acid interference,
or RNAi, that may be developed by us, uncertainties regarding
the scope of the clinical testing that may be required by
regulatory authorities for the drug candidates acquired from
Biorex Research and Development Company, RT, or Biorex, and
other products and the outcomes of those tests, the significant
time and expense that will be incurred in developing any of the
potential commercial applications for our small molecules or
RNAi technology, our need for additional capital to fund our
ongoing working capital needs, including ongoing research and
development expenses related to the drug candidates purchased
from Biorex, risks relating to the enforceability of any patents
covering our products and to the possible infringement of third
party patents by those products, and the impact of third party
reimbursement policies on the use of and pricing for our
products. All forward-looking statements and reasons why results
may differ included in this Annual Report are made as of the
date hereof, and we assume no obligation to update any such
forward-looking statement or reason why actual results might
differ.
PART I
General
CytRx Corporation is a biopharmaceutical research and
development company, based in Los Angeles, California, with an
operating obesity and type 2 diabetes subsidiary in
Worcester, Massachusetts. We are in the process of developing
products, primarily in the areas of small molecule therapeutics
and ribonucleic acid interference, or RNAi, for the human health
care market. RNAi is a new technology for silencing genes in
living cells and organisms. Our small molecule therapeutics
efforts include our clinical development of three, oral drug
candidates that we acquired in October 2004, as well as our drug
discovery operations conducted in the laboratory of our
subsidiary. In addition to our work in small molecule
therapeutics and RNAi, we are
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involved in the development of a DNA-based HIV vaccine and have
entered into strategic alliances with respect to the development
of several other products using our other technologies.
Since our incorporation in Delaware 1985, we have been engaged
in the development of pharmaceutical products. July 2002, the
time of our merger with Global Genomics Capital, Inc., or Global
Genomics, marked a change in the focus of our company.
Subsequent to the Global Genomics merger, we modified our
corporate business strategy by discontinuing any further
research and development efforts for our pre-merger
pharmaceutical technologies and began to seek strategic
relationships with other pharmaceutical companies to complete
the development of those technologies. Instead of continuing
research and development for those technologies, we focused our
efforts on acquiring new technologies and products to serve as
the foundation for the future of the company.
In April 2003, we acquired our first new technologies by
entering into exclusive license agreements with the University
of Massachusetts Medical School, or UMMS, covering potential
applications for the medical schools proprietary RNAi
technology in the treatment of specified diseases, including
those within the areas of obesity and type 2 diabetes;
amyotrophic lateral sclerosis, or ALS, commonly referred to as
Lou Gehrigs disease, which is a progressive
neurodegenerative disease that results in motor neuron
degeneration of the brain and spinal cord and eventual
paralysis; and human cytomegalovirus, or CMV, which is a herpes
virus that often affects HIV patients. At that time, we also
acquired an exclusive license from UMMS covering the medical
schools proprietary technology with potential gene therapy
applications within the area of cancer. In May 2003, we
broadened our strategic alliance with UMMS by acquiring an
exclusive license from that institution covering a proprietary
DNA-based HIV vaccine technology. In July 2004, we further
expanded our strategic alliance with UMMS by entering into a
collaboration and invention disclosure agreement with UMMS under
which UMMS will disclose to us certain new technologies
developed at UMMS over the next three years pertaining to RNAi,
diabetes, obesity, neurodegenerative diseases (including ALS)
and CMV and will give us an option, upon making a specified
payment, to negotiate an exclusive worldwide license to the
disclosed technologies on commercially reasonable terms.
As part of our strategic alliance with UMMS, we agreed to fund
certain discovery and pre-clinical research at the medical
school relating to the use of our technologies, licensed from
UMMS, for the development of therapeutic products within certain
fields. To date, we have entered into agreements with UMMS to
sponsor research in the areas of obesity and type 2
diabetes, ALS and CMV retinitis. In addition, we have entered
into an agreement with Massachusetts General Hospital to sponsor
research at that institution that will utilize our proprietary
gene silencing technology in the area of ALS.
In conjunction with our work with UMMS, in September 2003, we
purchased 95% of CytRx Laboratories, Inc. (formerly known as
Araios, Inc.), our research and development subsidiary, which
had been recently formed to develop small molecule and
RNAi-based therapeutics for the prevention, treatment and cure
of obesity and type 2 diabetes. This subsidiary is focusing
on using genomic and proteomic based drug discovery technologies
combined with our proprietary gene silencing technology to
accelerate the process of screening and identifying potential
drug targets and pathways for these diseases. Through this
subsidiary, we are seeking to develop orally active drugs
against promising targets and pathways relevant to obesity and
type 2 diabetes.
On October 4, 2004, we acquired all of the clinical and
pharmaceutical and related intellectual property assets of
Biorex Research & Development, RT, or Biorex, a
Hungary-based company focused on the development of novel small
molecules with broad therapeutic applications in neurology,
diabetes and cardiology. The acquired assets include three oral,
clinical stage drug candidates and a library of 500 small
molecule drug candidates. The acquisition positions us as a
clinical-stage company, as we expect to initiate a Phase II
trial for ALS with one of our new compounds, arimoclomol, in the
second quarter of 2005.
Although we intend to internally fund or carry out the research
and development related to the drug candidates that we acquired
from Biorex, and, through our obesity and type 2 diabetes
subsidiary, the early stage development work for certain product
applications based on the RNAi and other technologies that we
licensed from UMMS, we may also seek to secure strategic
alliances or license agreements with larger pharmaceutical
companies to fund the early stage development work for other
gene silencing product
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applications and for subsequent development of those potential
products where we fund the early stage development work.
Prior to 2003, our primary technologies consisted of Flocor, an
intravenous agent for treatment of sickle cell disease and other
acute vaso-occlusive disorders, and TranzFect, a delivery
technology for DNA and conventional-based vaccines. In October
2003, we entered into a strategic relationship with another
entity, which was recently formed, to complete the development
of Flocor. Our TranzFect technology has been licensed to two
companies. We have granted a third party an option to license
our TranzFect technology for development as a potential
DNA-based prostate cancer adjuvant and may also seek to license
this technology as a potential conventional adjuvant for
hepatitis C, human pappiloma virus, herpes simplex virus
and other viral diseases. Adjuvants are agents added to a
vaccine to increase its effectiveness. In addition, we may seek
to license TranzFect for use as a non-clinical research reagent
to increase transfection in vitro or in laboratory
animals. Flocor and TranzFect are further described under
Pre-Global Genomics Merger Technologies.
In addition, through our merger with Global Genomics, we
acquired minority interests in two development-stage genomics
companies, Blizzard and Psynomics. In 2003, we recorded a
write-off of our investments in those companies. Our decision to
record the write-off was based upon several factors. Those
investments, and the write-off of those investments, are further
described under Genomics Investments.
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Molecular Chaperone Co-inducers |
The synthesis of proteins is a normal part of every cells
activity that is essential for life. Proteins are linear chains
of building blocks known as amino acids. In order to function
normally in a cell, proteins must fold into particular three
dimensional shapes. During stressful conditions (e.g.
during certain disease states), proteins can fold into
inappropriate shapes that result in aggregation of proteins,
which can be toxic to the cell. As an example, it is believed
that mis-folding and aggregation of certain mutated forms of the
superoxide dismutase 1 (SOD1) protein leads to the death of
motor neurons that causes ALS.
In nature, the cell has developed a way to deal with these
potentially toxic mis-folded proteins. Molecular
chaperone proteins are a key component of a
universal cellular protection, maintenance and repair mechanism
that helps ensure that newly synthesized proteins are complete,
taken to the correct position within the cells structure,
and correctly folded. Molecular chaperones detect proteins that
are mis-folded, and have the ability to refold those proteins
into the appropriate, non-toxic shape. However, if the protein
is so badly mis-folded that it cannot be repaired, the molecular
chaperones also have the ability to tag the toxic
protein for destruction by the cell. This tag, called ubiquitin,
directs the mis-folded protein to a cellular apparatus called
the proteasome, whose function is to degrade the protein into
its constituent amino acids for recycling.
A core element of the cells stress-management techniques
is known as the heat shock response. Although this response was
so-named because it was initially discovered by subjecting cells
to heat stress, it is now known that the heat shock response is
generally induced by a variety of physical and chemical
stresses. As a cell comes under stress, proteins begin to
mis-fold into toxic shapes. The heat shock response (also
referred to as the stress response) increases the synthesis of
molecular chaperones that then repair the mis-folded proteins.
The stress response can be an important mechanism for cellular
survival during certain acute physical stresses. For instance,
prior induction of the stress response can protect tissue
culture cells from heat-induced cell death. However, it appears
that the constant stress that occurs as a result of chronic
disease dulls the stress response and erodes the effectiveness
of the mechanism. For instance, although the stress response is
slightly induced in the motor neurons of transgenic mice that
express the human mutated SOD1 gene that causes certain cases of
ALS, the level of expression is apparently insufficient to
repair the damage and the mice still die from the disease.
We believe that by boosting the stress response to higher
levels, the progression of chronic disease can be slowed, halted
or reversed and affected cells can be restored to full
functionality. In in vitro studies, mammalian cells
engineered to over-express molecular chaperones have increased
cross-protection against a
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variety of otherwise lethal and toxic stresses. In in vivo
studies, transgenic mice engineered to over-express a
molecular chaperone had improved myocardial function, preserved
metabolic function and reduced infarct size after
ischemia/reperfusion. Increased molecular chaperone expression
also significantly increased the lifespan in a mouse model for
spinal and bulbar muscular atrophy, a motor neuron disease. We
believe that these studies give substantial support within the
scientific community for new drugs that are capable of
activating a cytoprotective stress response.
Among the assets recently acquired from Biorex were several drug
candidates whose mechanism of action is believed to be the
co-induction of the stress response, meaning that
they do not seem to activate the stress response by themselves,
but instead they amplify the production of molecular chaperone
proteins that are already activated by disease-induced cellular
stress. These drug candidates thus may selectively amplify
molecular chaperone proteins specifically in diseased tissue,
which would minimize potential drug side-effects. The
amplification of this fundamental protective mechanism may have
powerful therapeutic and prophylactic potential, with the
potential for an extremely broad field of medical therapeutic
utility.
We believe that the drug candidates acquired from Biorex can
potentially improve the cells natural capability to resist
the toxic effects of protein mis-folding, caused by both acute
and chronic diseases. Thus, these orally available small
molecule drug candidates may accomplish the same goals as RNAi,
as described below, but accomplish them by repairing or
degrading the offending proteins, instead of degrading their
corresponding mRNAs. Since the specificity for the recognition
of mis-folded proteins is an intrinsic feature of the amplified
molecular chaperones, it is not necessary to identify the actual
molecular target of the stress-induced damage. As a result,
these drug candidates may allow broader therapeutic utility for
the removal of damaged proteins compared to that of RNAi.
We are not aware of other pharmaceutical companies developing
small molecule co-inducers of molecular chaperones. At present,
a few potential drug candidates have been reported in the
literature to activate molecular chaperone expression, but these
do not require pre-activation of the stress response, and
therefore these drug candidates may simply represent a
stress to the cell.
RNAi technology is a recently discovered technology that uses
short double-stranded RNA, or dsRNA, molecules to silence
targeted genes and, as a result, is commonly referred to as
gene silencing. RNAi has been shown to effectively
silence targeted genes within living cells with great
specificity and potency. As a result, RNAi technology is able to
effectively silence targeted genes without impacting other,
non-targeted, genes.
RNA is a polymeric constituent of all living cells and many
viruses, consisting of a long, usually single-stranded chain of
alternating phosphate and ribose units with the bases adenine,
guanine, cytosine, and uracil bonded to the ribose. The
structure and base sequence of RNA are determinants of protein
synthesis and the transmission of genetic information. RNAi is a
technique of using short pieces of double-stranded RNA to
precisely target the messenger RNA, or mRNA, of a specific gene.
The end result is the destruction of the specific mRNA, thus
silencing that gene.
RNAi is regarded as a significant advancement in gene silencing
and was featured in Science magazine as the
Breakthrough of the Year in 2002. Delivery of RNAi
can be in vitro and in vivo to target
specific mRNAs, thus reducing the levels of the specific protein
product coded for by that gene in the targeted cells. This
allows the use of RNAi either as an effective drug discovery
tool or potentially as a therapeutic product itself. We intend
to develop RNAi technology as both a discovery tool for
classical, orally-available small molecule drugs and for direct
therapeutic applications when technically feasible. As a drug
discovery tool, we intend to use RNAi to identify and validate
novel targets, which could then be used to discover small
molecule therapeutics for the treatment and prevention of
obesity and type 2 diabetes. As a therapeutic, we are conducting
pre-clinical efficacy studies to determine whether to proceed
with human clinical trials using RNAi to silence specific genes
that cause ALS, CMV retinitis and type 2 diabetes. In January
2004, Tariq Rana, a scientific authority in delivery and
stability of RNAi, and in March 2004, Dr. Craig Mello, the
co-
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discoverer of RNAi, each joined our Scientific Advisory Board
and they will act in an advisory capacity to help us develop
therapeutics for specific diseases.
In mammals and human cells, gene silencing can be triggered by
delivering dsRNA molecules directly into the cells
cytoplasm (the region inside the cell membrane but outside the
cell nucleus). Specific enzymes (proteins) in the cell
called dicer enzymes cut the dsRNA to form small interfering
RNA, or siRNA. These siRNA are approximately 21 to 25 nucleotide
long pieces of RNA. The siRNA then interact with other cellular
proteins to form the RNA-induced silencing complex, or RISC,
which causes the unwinding of the bound siRNA. This unwound
strand of the siRNA can then act as a template to seek out and
bind with the complementary target mRNA, which carries the
coding, or instructions, from the cell nucleus DNA. These
instructions determine which proteins the cell will produce.
When the siRNA-loaded RISC binds with the corresponding mRNA,
that message is degraded and the cell does not
produce the specific protein that it encodes. Since the siRNA
can be designed to specifically interact with a single gene
through its mRNA, it can prevent the creation of a specific
protein without affecting other genes.
One reason for the potential of RNAi to be effective, where
previous nucleic acid-based technologies have, to date, been
unsuccessful, is that the cell already has in place all of the
enzymes and proteins to effectively silence genes once the dsRNA
is introduced into the cell. This is in direct contrast to the
older technology of antisense, where there were no known
proteins present in the cells to facilitate the recognition and
binding of the antisense molecule to its corresponding mRNA.
Another reason for the interest in RNAi is its potential to
completely suppress or eliminate the viral replicon. A replicon
is a DNA or RNA element that can act as a template to replicate
itself. Once a virus is established in a cell, there are very
few drugs that are effective in eliminating the virus. The RNAi
process, however, has the potential of eliminating viral nucleic
acids and, therefore, to cure certain viral diseases.
Development work on RNAi is still at an early stage, and we are
aware of only two clinical trials using RNAi, namely safety
trials for age-related macular degeneration by Acuity
Pharmaceuticals and Sirna Therapeutics.
Product Development
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University of Massachusetts Medical School |
Through our strategic alliance with UMMS, we have acquired the
rights to a portfolio of technologies, including the rights to
use UMMSs proprietary RNAi technology with potential
therapeutic applications in certain defined areas that include
obesity, type 2 diabetes, ALS and CMV, as well as a DNA-based
HIV vaccine technology and a cancer therapeutic technology. In
addition, we have entered into a collaboration and invention
disclosure agreement with the UMMS under which UMMS will
disclose to us certain new technologies developed at UMMS over
the next three years pertaining to RNAi, diabetes, obesity,
neurodegenerative diseases (including ALS) and CMV and will give
us an option, upon making a specified payment, to negotiate an
exclusive worldwide license to the disclosed technologies on
commercially reasonable terms.
The HIV subunit vaccine technology that we have licensed from
UMMS is based upon a unique mixture of pieces of human HIV-1
primary isolates from several genetic subtypes of HIV. These
pieces, called HIV envelope proteins, are not sufficient for
viral replication and therefore cannot lead to accidental
infection by HIV. This polyvalent naked DNA (isolated, purified
DNA) vaccine approach has the potential advantages of
maintaining efficacy despite the high mutation rate of HIV, a
broader immune response against divergent HIV-1 glycoproteins
and the possible ability to neutralize a wide spectrum of HIV-1
viruses. UMMS has conducted animal studies of this vaccine, and
UMMS and Advanced BioScience Laboratories, or ABL, which
provides an adjuvant for use with the vaccine, have received a
$16 million grant from the NIH. This grant is currently
funding a Phase I clinical trial of a vaccine candidate
using our licensed technology. The investigational new drug
application, or IND, for that trial was filed in January 2004
and allowed by the FDA to go into effect in March 2004.
Enrollment of volunteers for this trial began in April 2004, and
we anticipate completing this trial in the first half of 2006.
We have a commercial relationship with ABL which gives us the
ownership of, and responsibility for, the further development of
the vaccine and subsequent FDA registration following the
completion of the Phase I trial, which is being conducted
by UMMS and ABL. We do not have
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a commercial relationship with a company that is providing an
adjuvant for the HIV vaccine candidate in the current
Phase I clinical trial. In any future clinical development
of the vaccine candidate, we may be required either to license
that adjuvant, or use a different adjuvant in conjunction with
our HIV vaccine technology, in which case we may not be able to
utilize some or all of the results of the currently planned
trial as part of our clinical data for obtaining FDA approval of
a vaccine.
Finally, we have also licensed a cancer treatment technology
from UMMS that is based on a naked DNA approach in which the DNA
material will be delivered by direct injection into the tumor or
other localized administration.
Our agreements with UMMS may require us to make significant
expenditures to fund research at the institution relating to
developing therapeutic products based on UMMSs proprietary
technologies that have been licensed to us. We estimate that the
aggregate amount of these sponsored research expenditures under
our current commitments will be approximately $1.3 million
for 2005 and approximately $737,000 for 2006. Our license
agreements with UMMS require us to make payments of an aggregate
of up to $105,000 per year to maintain all of our licenses,
with such aggregate annual payments increasing to as much as
$145,000 if we are not then conducting certain sponsored
research at the institution. Our UMMS license agreements also
provide, in certain cases, for milestone payments, from us to
UMMS, based on the progress we make in the clinical development
and marketing of products utilizing the technologies licensed
from UMMS. In addition, our license agreements with UMMS require
us to reimburse UMMS for legal expenses that they incur in
prosecuting and maintaining of the related licenses patents. We
estimate these legal expenses to be approximately
$200,000 per year. In the event that we were to
successfully develop a product in each of the categories of
obesity/type 2 diabetes, ALS, CMV, cancer and an HIV vaccine,
under our licenses, those milestone payments could aggregate up
to $16.1 million. Those milestone payments, however, could
vary significantly based upon the milestones we achieve and the
number of products we ultimately undertake to develop. In
addition, our collaboration and invention disclosure agreement
with UMMS requires us to make payments totaling $750,000 in 2005
in consideration for the option, upon making a specified
payment, to negotiate an exclusive worldwide license to certain
disclosed technologies.
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Obesity and Type 2 Diabetes |
Obesity and type 2 diabetes are significant health problems. The
World Health Organization estimates that, on a worldwide basis,
there are more than 300 million cases of obesity and
159 million cases of type 2 diabetes. According to the
American Obesity Association, there are currently more than
60 million cases of obesity in the United States, and the
American Diabetes Association reports that there are more than
16 million cases of type 2 diabetes in the United States.
Scientists at UMMS, as part of our strategic alliance, are
researching, with funding that we have provided, the specific
genetic relationship of type 2 diabetes to obesity. The research
is focused on using cultured adipocytes (fat cells) as a model
system for studying the regulation of gene expression involved
in adipocyte differentiation and function. This research may
lead to the identification of specific drug targets which
regulate insulin signaling as well as other metabolic pathways
regulating glucose and fatty acids. With this understanding, the
program will focus on drug discovery of small molecule
therapeutics and potentially RNAi-based therapeutics for type 2
diabetes (e.g., drugs that act as insulin sensitizers and
compounds that alleviate obesity). We believe that RNAi could
potentially be a reliable method to selectively inhibit certain
genes and their corresponding protein expression in adipocytes.
In May 2004, we licensed from the technology transfer company of
the Imperial College of Science, Technology & Medicine
the exclusive rights to intellectual property covering a drug
screening method using RIP 140, which is a nuclear hormone
co-repressor that is believed to regulate fat accumulation. This
proprietary technology is covered by a pending patent
application. We paid the licensor a license fee in the form of
cash and shares of our common stock, and we will be required to
make defined milestone and royalty payments based on sales of
products developed using this technology. We believe this
license provides us with an important potential drug target in
the area of obesity and type 2 diabetes in conjunction with our
gene silencing technology.
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In addition, one of the drug candidates acquired from Biorex,
iroxanadine, was shown to be well tolerated in two Phase I
and one Phase II clinical trials and demonstrated
significant improvement of vascular function in the brachial
artery of hypertensive patients. We plan to evaluate the
preclinical efficacy of this drug for two diabetic complications
that involve vascular dysfunction, retinopathy and wound
healing. If the drug proves to be efficacious in preclinical
work and the FDA agrees that it is appropriate to proceed with a
Phase II clinical trial, we believe that a Phase II
clinical trial for either of these indications could begin in
2006.
Although we initially intend to develop arimoclomol, another of
the drug candidates acquired from Biorex, for the treatment of
ALS, the drug also showed efficacy in preclinical animal models
of diabetes. If efficacy is observed in additional preclinical
models, we would also consider beginning a Phase II
clinical trial for diabetes in 2006, as arimoclomol has already
been tested in two Phase I clinical trials.
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Research and Development Subsidiary |
In addition to the obesity and diabetes work being done under
our sponsored research agreement with UMMS, in September 2003,
we purchased 95% of CytRx Laboratories, Inc. (formerly known as
Araios, Inc.), our research and development subsidiary, which
had been recently formed by Dr. Michael P. Czech to develop
orally active small molecule and RNAi-based drugs for the
prevention, treatment and cure of obesity and type 2 diabetes.
Our business strategy is to use our portfolio of state of the
art drug discovery technologies and our relationships with
leading diabetes and obesity researchers to discover and develop
first in class medicines to prevent, treat and cure obesity and
type 2 diabetes. Utilizing the RNAi target validation technology
that we have licensed from UMMS, in combination with state of
the art target identification methods, our research and
development subsidiary will focus on using a structure based
drug discovery approach to accelerate the process of screening
and identifying potential drug targets and pathways for these
diseases. Through our subsidiary, we will seek to develop orally
administered drugs that are based on promising targets and
pathways that we may be able to identify.
Dr. Czech is a prominent scientist in the fields of obesity
and type 2 diabetes at UMMS, is a member of our Scientific
Advisory Board, heads our subsidiarys Scientific Advisory
Board and holds a 5% equity interest in the subsidiary. We
provided the subsidiary in September 2003 with initial capital
of approximately $7,000,000 to fund the staffing of its
operations with managerial and scientific personnel and its
initial drug development activities.
Through our license and sponsored research agreement with UMMS,
we have secured rights to novel drug targets believed to be
involved in obesity and type 2 diabetes. We will seek to
validate these targets using the proprietary high throughput
RNAi technology that we have licensed from UMMS and will apply
state of the art structure-based medicinal chemistry to develop
small molecules and RNAi-based therapeutic products.
The development of therapeutics for the treatment of various
forms of ALS is an area of significant interest for us. ALS is a
debilitating disease. According to the ALS Survival Guide, 50%
of ALS patients die within 18 months of diagnosis and 80%
of ALS patients die within five years of diagnosis. According to
the ALS Association, in the United States, alone, approximately
30,000 people are living with ALS and nearly 6,000 new cases are
diagnosed each year.
Our drug candidate, arimoclomol, acquired from Biorex in October
2004, was previously shown to be well tolerated in two
Phase I clinical trials in healthy volunteers. Based on
this, and results indicating efficacy of the drug candidate in
animal models of neuronal damage, including the published
efficacy data of the drug in animal models of ALS, we expect to
begin a Phase II clinical trial with arimoclomol for the
treatment of ALS in the second quarter of 2005. We are scheduled
to discuss the proposed Phase II clinical trial with the
FDA in the coming weeks.
In October 2003, we entered into sponsored research agreements
with UMMS and Massachusetts General Hospital, pursuant to which
we will sponsor certain ALS research at those institutions
utilizing our
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proprietary gene silencing technology targeted at the mutant
SOD1 gene, which is the subject of the ALS technology we have
licensed from UMMS. The mutant SOD1 gene is responsible for
causing ALS in a subset of the 10% of all ALS patients who
suffer from the familial, or genetic, form of the disease.
Dr. Zuoshang Xu, an Associate Professor of Biochemistry and
Molecular Pharmacology at UMMS, is the principal investigator
under our sponsored research agreement with UMMS. We have funded
approximately $302,000 of research under that agreement during
its first year, and have committed to fund approximately
$280,000 of research under that agreement during its second year
and approximately $288,000 of research under that agreement
during the third year of the program.
Dr. Robert B. Brown, Jr., a Professor of Neurology at
Harvard Medical School, Founder and Director of the Cecil B. Day
Laboratory for Neuromuscular Research and a co-discoverer of the
mutant SOD1 gene as a cause for certain ALS cases, is the
principal investigator under our sponsored research agreement
with Massachusetts General Hospital. Under the agreement, we
have agreed to fund approximately $487,000 of sponsored research
at Massachusetts General Hospital through the end of 2005. In
March 2004, Dr. Brown joined our Scientific Advisory Board
and entered into a consulting agreement with us.
Preclinical results by third parties with our drug candidate,
iroxanadine, indicate that it has therapeutic potential for the
treatment of cardiovascular atherosclerosis. If iroxanadine
proves to be effective in additional preclinical work, we plan
to seek a strategic alliance with a larger company to support
the subsequent clinical development for this indication.
Pre-Global Genomics Merger Technologies
|
|
|
Therapeutic Copolymer Program |
Prior to the merger with Global Genomics, our primary focus was
on CRL-5861 (purified poloxamer 188), which we also call
Flocor. Flocor is an intravenous agent for the treatment of
sickle cell disease and other acute vaso-occlusive disorders.
Sickle cell disease is an inherited disease caused by a genetic
mutation of hemoglobin in the blood, and acute vaso-occlusive
disorders are a blockage of blood flow caused by deformed, or
sickled, red blood cells which can cause intense
pain in sickle cell disease patients. In June 2004, we licensed
our copolymer technologies, including Flocor, on an exclusive
basis, to SynthRx, Inc., a Houston, Texas-based
biopharmaceutical company. As a result of the SynthRx license,
we received a 19.9% ownership interest in SynthRx and a cash
payment from SynthRx of approximately $228,000, in return for
our rights to the licensed technologies. In addition, upon
commercialization of any products developed under our alliance
with SynthRx, we may also receive significant milestone payments
and royalties. Prior to the change in our business strategy that
led us to seek licensees for our Flocor technology, we had
internally developed Flocor. In December 1999, we reported
results from a Phase III clinical study of Flocor for
treatment of acute sickle cell crisis. Although the study did
not demonstrate statistical significance in the primary
endpoint, or objective, of the study, statistically significant
and clinically important benefits associated with Flocor were
observed in certain subgroups. All amounts paid to us by SynthRx
are non-refundable upon termination of the agreement and require
no additional effort on our part.
|
|
|
Vaccine Enhancement and Gene Therapy |
Gene therapy and gene-based vaccines are mediated through the
delivery of DNA containing selected genes into cells by a
process known as transfection. We refer to our gene delivery
technology as TranzFect. A large majority of the revenues we
have generated over the past three years has been due to license
fees paid to us with respect to our TranzFect technology,
representing 93%, 81% and 94% of our total revenues for 2004,
2003 and 2002, respectively.
8
In November 2000, we entered into an exclusive, worldwide
license agreement with Merck & Co., Inc. whereby we
granted Merck the right to use our TranzFect technology in
DNA-based vaccines for HIV and three other targets. To date,
Merck has focused its efforts on the HIV application, which is
still at an early stage of clinical development, and, in July
2003, Merck notified us that it was returning to us the rights
to the three other targets covered by its license, which we are
now able to license to other third parties. In November 2000,
Merck paid us a signature payment of $2 million. In
February 2002, we received an additional $1 million
milestone fee related to the commencement of Mercks first
FDA Phase I study for a product incorporating TranzFect
designed for the prevention and treatment of HIV. Merck
completed a multi-center, blinded, placebo controlled
Phase I trial of an HIV vaccine utilizing TranzFect as a
component. Although the formulation of this tested vaccine was
generally safe, well-tolerated and generated an immune response,
the addition of TranzFect to the vaccine did not increase this
immune response. Moreover, the DNA single-modality vaccine
regimen with TranzFect, when tested in humans, yielded immune
responses that were inferior to those obtained with the DNA
vaccines in macaque monkeys. All amounts paid to us by Merck are
non-refundable upon termination of the agreement and require no
additional effort on our part.
In December 2001, we entered into a license agreement with Vical
Incorporated granting Vical exclusive, worldwide rights to use
or sublicense our TranzFect poloxamer technology to enhance
viral or non-viral delivery of polynucleotides, such as DNA and
RNA, in all preventive and therapeutic human and animal health
applications, except for (1) the four targets previously
licensed by us to Merck, (2) DNA vaccines or therapeutics
based on prostate-specific membrane antigen, or PSMA, and
(3) sale of a non-regulated product for use as a
non-clinical research reagent to increase transfection
in vitro or in laboratory animals. In addition, the
Vical license permits Vical to use TranzFect poloxamer
technology to enhance the delivery of proteins in prime-boost
vaccine applications that involve the use of polynucleotides
(short segments of DNA or RNA). Under the Vical license, we
received a non-refundable up-front payment of $3,750,000, and,
in addition to annual maintenance payments, we have the
potential to receive milestone and royalty payments in the
future based on criteria described in the agreement. In April
2004, we received an additional $100,000 milestone fee
related to the commencement of Vicals first FDA
Phase I clinical trial for a product incorporating our
TranzFect technology. All amounts paid to us by Vical are
non-refundable upon termination of the agreement and require no
additional effort on our part.
2002 Merger with Global Genomics
On July 19, 2002, we completed the acquisition of Global
Genomics. The acquisition of Global Genomics was accomplished
through a merger of our wholly-owned subsidiary, GGC Merger
Corporation, with and into Global Genomics. Global Genomics was
the surviving corporation in the merger with GGC Merger
Corporation and is now our wholly-owned subsidiary. We have
changed Global Genomics name to GGC Pharmaceuticals, Inc.,
but for purposes of this Annual Report, we will continue to
refer to the company as Global Genomics. For accounting
purposes, we were deemed the acquiror of Global Genomics.
In the Global Genomics merger, each outstanding share of common
stock of Global Genomics was converted into 0.765967 shares
of our common stock. Accordingly, a total of
8,948,204 shares of our common stock, or approximately
41.7% of our common stock outstanding immediately after the
merger, were issued to the common stockholders of Global
Genomics, and an additional 1,014,677 shares of our common
stock were reserved for issuance upon the exercise of the
outstanding Global Genomics warrants that we assumed in the
merger. Other than the foregoing stock, we paid no other
consideration to the Global Genomics shareholders.
At the time of the Global Genomics merger, there were no
material relationships between Global Genomics or any of its
shareholders or affiliates and us, except that on July 16,
2002, Global Genomics three designees to our board of
directors, Steven A. Kriegsman, Louis J. Ignarro, Ph.D. and
Joseph Rubinfeld, Ph.D., were elected directors and
Mr. Kriegsman became our Chief Executive Officer.
Mr. Kriegsman was Global Genomics Chairman and
Dr. Ignarro was a director of Global Genomics at that
9
time. On the date of the merger, the controlling shareholder of
Global Genomics was Mr. Kriegsman, who beneficially owned,
on a fully diluted basis, approximately 40.4% of Global
Genomics equity interests.
Genomics Investments
In connection with our merger with Global Genomics, we acquired
indirectly equity interests in two development-stage genomics
companies, a 40% equity interest in Blizzard and a 5% equity
interest in Psynomics. In the fourth quarter of 2003, we decided
that we would cease funding our investments in those genomics
companies to focus on our core strategy of developing human
therapeutics for large market indications. In May 2004, we
determined that a write-off of those investments in the third
quarter of 2003 should have been made. Our decision to record
the write-off was based upon several factors, including
Blizzards lack of success in raising a significant amount
of the financing necessary for it to pursue the
commercialization strategy for its products, current financial
projections prepared by Blizzard, application of a discounted
cash flow valuation model of Blizzards projected cash
flows and the consideration of other qualitative factors. Based
upon the quantitative and qualitative factors described above,
in addition to others, we determined that the investment in
Blizzard had no remaining value as of September 30, 2003
and that a write-off of this investment should have been made in
the third quarter of 2003. It is our understanding that, by the
end of 2003, Blizzard had ceased operations and was in the
process of returning its licensed intellectual property to the
University of Minnesota.
Research and Development Expenditures
Expenditures for research and development activities related to
continuing operations were $9.0 million, $4.4 million
and $767,000 during the years ended December 31, 2004, 2003
and 2002, respectively. Included in research and development
expenses for 2004 was $3.0 million of in-process research
and development that was written off in conjunction with our
acquisition of assets from Biorex.
Manufacturing
We do not have the facilities or expertise to manufacture any of
the clinical or commercial supplies of any of our products. 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. To date, we
have not commercialized any products, nor have we demonstrated
that we can manufacture commercial quantities of our product
candidates in accordance with regulatory requirements. If we
cannot manufacture products in suitable quantities and in
accordance with regulatory standards, either on our own or
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 research, clinical trials and,
ultimately, for product commercialization.
Patents and Proprietary Technology
We actively seek patent protection for our technologies,
processes, uses, and ongoing improvements and consider our
patents and other intellectual property to be critical to our
business. We have filed applications for a number of patents and
have been granted patents related to technologies, primarily
TranzFect and Flocor, we were developing prior to our 2002
merger with Global Genomics. Subsequent to the merger, we
acquired patents in connection with our acquisition of
intellectual property rights of Biorex and we have licensed
additional technologies covered by patents or patent
applications, most of which are in the RNAi field.
As part of our development process, we evaluate the
patentability of new inventions and improvements developed by us
or our collaborators. Whenever appropriate, we will endeavor to
file United States and international patent applications to
protect these new inventions and improvements. However, we
cannot be
10
certain that any of the current pending patent applications we
have filed or licensed, or any new patent applications we may
file or license, will ever be issued in the United States or any
other country. Even if issued, there can be no assurance that
those patents will be sufficiently broad to prevent others from
using our products or processes. Furthermore, our patents, as
well as those we have licensed or may license in the future, may
be held invalid or unenforceable by a court, or third parties
could obtain patents that we would need to either license or to
design around, which we may be unable to do. Current and future
competitors may have licensed or filed patent applications or
received patents, and may acquire additional patents and
proprietary rights relating to small molecule technology, RNAi
technology, DNA-based vaccines or other compounds, products or
processes competitive with ours.
In addition to patent protection, we also attempt to protect our
proprietary products, processes and other information by relying
on trade secrets and non-disclosure agreements with our
employees, consultants and certain other persons who have access
to such products, processes and information. Under the
agreements, all inventions conceived by employees are our
exclusive property. Nevertheless, there can be no assurance that
these agreements will afford significant protection against
misappropriation or unauthorized disclosure of our trade secrets
and confidential information.
Competition
Currently, Rilutek®, which was developed by Aventis Pharma
AG, is the only drug of which we are aware that has been
approved by the FDA for the treatment of ALS. Other companies
are working to develop pharmaceuticals to treat ALS, including
Aeolus Pharmaceuticals and Oxford BioMedica plc. In addition,
ALS belongs to a family of diseases called neurodegenerative
diseases, which includes Alzheimers, Parkinsons and
Huntingtons disease. Due to similarities between these
diseases, a new treatment for one ailment potentially could be
useful for treating others. There are many companies that are
producing and developing drugs used to treat neurodegenerative
diseases other than ALS, including Amgen, Inc., Guilford
Pharmaceuticals, Phytopharm plc, Cephalon, Inc. and Ceregene,
Inc.
The RNAi field, though at an early stage of development, is
already a competitive one and the competition is expected to
increase. We face competition on many fronts ranging
from large and small pharmaceutical, chemical and biotechnology
companies to universities, government agencies and other public
and private research organizations. Examples of companies that
are focusing their commercial efforts in the RNAi field are
Sirna Therapeutics, Alnylam Pharmaceuticals and Benitec Ltd. A
number of the multinational pharmaceutical companies also either
have their own gene silencing product development programs or
are working with smaller biopharmaceutical companies in this
area. In addition to our RNAi competitors, companies in other
fields may be using other technologies to target the same
diseases that we are targeting. The competition from other firms
and institutions will manifest itself not only in our potential
product markets but also, and importantly at this stage in
development of RNAi technology, in recruiting and retaining key
scientific and management personnel.
Companies developing HIV vaccines that could compete with our
HIV vaccine technology include Merck, VaxGen, Inc., Epimmune,
Inc., AlphaVax, Inc. and Immunitor Corporation, and ABL may also
seek to develop competing HIV vaccines that could utilize a
portion of the technology that we have licensed from UMMS and
ABL.
With respect to both our RNAi and non-RNAi products, many
companies, including large pharmaceutical and biotechnology
firms with financial resources, research and development staffs,
and facilities that may, in certain cases, be substantially
greater than those of ours or our strategic partners or
licensees, are engaged in the research and development of
pharmaceutical products that could compete with our potential
products. To the extent that we seek to acquire, through license
or otherwise, existing or potential new products, we will be
competing with numerous other companies, many of which will have
substantially greater financial resources, large acquisition and
research and development staffs that may give those companies a
competitive advantage over us in identifying and evaluating
these drug acquisition opportunities. Any products that we
acquire will be competing with products marketed by companies
that in many cases will have substantially greater marketing
resources than we have. The industry is characterized by rapid
technological advances and competitors may
11
develop their products more rapidly and such products may be
more effective than those currently under development or that
may be developed in the future by our strategic partners or
licensees. Competitive products for a number of the disease
indications that we have targeted are currently being marketed
by other parties, and additional competitive products are under
development and may also include products currently under
development that we are not aware of or products that may be
developed in the future.
Government Regulation
The marketing of pharmaceutical products requires the approval
of the FDA and comparable regulatory authorities in foreign
countries. The FDA has established guidelines and safety
standards which apply to the pre-clinical evaluation, clinical
testing, manufacture and marketing of pharmaceutical products.
The process of obtaining FDA approval for a new drug product
generally takes a number of years and involves the expenditure
of substantial resources. The steps required before such a
product can be produced and marketed for human use in the United
States include preclinical studies in animal models, the filing
of an Investigational New Drug (IND) application, human clinical
trials and the submission and approval of a New Drug Application
(NDA) or a Biologics License Application (BLA). The NDA or BLA
involves considerable data collection, verification and
analysis, as well as the preparation of summaries of the
manufacturing and testing processes, preclinical studies, and
clinical trials. The FDA must approve the NDA or BLA before the
drug may be marketed. There can be no assurance that we or our
strategic alliance partners or licensees will be able to obtain
the required FDA approvals for any of our products.
The manufacturing facilities and processes for our products,
which we anticipate will be manufactured by our strategic
partners or licensees or other third parties, will be subject to
rigorous regulation, including the need to comply with Federal
Good Manufacturing Practice regulations. Our manufacturers also
will be subject to regulation under the Occupational Safety and
Health Act, the Environmental Protection Act, the Nuclear Energy
and Radiation Control Act, the Toxic Substance Control Act and
the Resource Conservation and Recovery Act.
Employees
As of December 31, 2004, we had 23 full-time employees, 14
of whom were engaged in research and development activities and
nine of whom were involved in management and administrative
operations. All of the employees engaged in research and
development activities hold Ph.D. degrees, and one also holds an
M.D. degree.
Our operations are based in Los Angeles, California, and
Worcester, Massachusetts. The lease for our headquarters
facility in Los Angeles covers approximately 3,300 square
feet of office space and expires in June 2005. We are currently
considering renewing the lease or alternatively locating
substantially similar, alternative office space. The lease for
our subsidiary in Worcester covers approximately
6,900 square feet of office and laboratory space and
expires in December 2005. Our facilities are suitable and
adequate for our current operations. We have the right to extend
the Worcester lease until December 2007.
|
|
Item 3. |
Legal Proceedings |
We are occasionally involved in claims arising out of our
operations in the normal course of business, none of which are
expected, individually or in the aggregate, to have a material
adverse effect on us.
In February 2004, we were notified by the Massachusetts State
Ethics Commission, or the Massachusetts Commission, that it had
initiated a preliminary inquiry into whether our previous
retention of a consultant who introduced us to UMMS constituted
an improper conflict of interest under Massachusetts
ethics laws. UMMS has advised us that it continues to believe
that its agreements with us provided excellent value for UMMS,
that it anticipates that the Massachusetts Commissions
review of the terms of those agreements will confirm that the
agreements were fair to UMMS, and that it believes that the
Massachusetts Commission will
12
concur with the resolution of the conflict proposed by UMMS
under which the consultant will forfeit to UMMS certain of the
compensation that the consultant was to receive from us.
|
|
Item 4. |
Submission of Matters to a Vote of Security Holders |
Our annual meeting of stockholders was convened on July 21,
2004, and adjourned until August 12, 2004, for the
following purposes:
|
|
|
1. To elect two directors to serve until our 2007 annual
meeting of stockholders; and |
|
|
2. To ratify the selection of BDO Seidman, LLP as
independent auditors for the fiscal year ended December 31,
2004. |
The number of outstanding shares of our common stock as of the
record date for the annual meeting was 34,777,256, of which in
excess of 31,636,832 shares were represented at the annual
meeting.
Dr. Louis Ignarro and Dr. Joseph Rubinfeld were
reelected at the annual meeting as our Class I directors to
serve until the 2007 annual meeting of stockholders. Steven A.
Kriegsman, Marvin R. Selter and Richard L. Wennekamp, our
Class II directors, and Max Link, our Class III
director, continued to serve as directors after the annual
meeting.
The following table sets forth the number of votes cast for,
against, or withheld for each director nominee, as well as the
number of abstentions and broker non-votes as to each such
director nominee:
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Votes Cast Against | |
|
|
|
Broker | |
Director Nominee |
|
Votes Cast For | |
|
or Withheld | |
|
Abstentions | |
|
Non-Votes | |
|
|
| |
|
| |
|
| |
|
| |
Dr. Louis Ignarro
|
|
|
30,401,297 |
|
|
|
1,235,669 |
|
|
|
|
|
|
|
|
|
Dr. Joseph Rubinfeld
|
|
|
31,238,051 |
|
|
|
398,781 |
|
|
|
|
|
|
|
|
|
With respect to the proposal to ratify the selection of BDO
Seidman, LLP as independent auditors for the fiscal year ending
December 31, 2004: (i) 31,354,283 votes were cast for,
(ii) 201,147 votes were cast against,
(iii) 81,513 shares abstained and (iv) there were
no broker non-votes with respect to the proposal. Accordingly,
the proposal was approved by our stockholders.
13
PART II
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|
Item 5. |
Market for Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities |
Our common stock is currently traded on the Nasdaq SmallCap
Market under the symbol CYTR. The following table
sets forth the high and low sale prices for our common stock for
the periods indicated as reported by the Nasdaq Stock Market.
Such prices represent prices between dealers without adjustment
for retail mark-ups, mark-downs, or commissions and may not
necessarily represent actual transactions.
|
|
|
|
|
|
|
|
|
|
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|
High | |
|
Low | |
|
|
| |
|
| |
Fiscal Year 2005:
|
|
|
|
|
|
|
|
|
|
|
January 1 to March 28
|
|
$ |
2.07 |
|
|
$ |
1.14 |
|
Fiscal Year 2004:
|
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$ |
1.75 |
|
|
$ |
1.10 |
|
|
Third Quarter
|
|
$ |
1.80 |
|
|
$ |
0.94 |
|
|
Second Quarter
|
|
$ |
2.10 |
|
|
$ |
1.06 |
|
|
First Quarter
|
|
$ |
2.43 |
|
|
$ |
1.43 |
|
Fiscal Year 2003:
|
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$ |
2.50 |
|
|
$ |
1.75 |
|
|
Third Quarter
|
|
$ |
2.81 |
|
|
$ |
1.58 |
|
|
Second Quarter
|
|
$ |
3.74 |
|
|
$ |
0.62 |
|
|
First Quarter
|
|
$ |
0.61 |
|
|
$ |
0.23 |
|
On March 28, 2005, the closing price of our common stock as
reported on the Nasdaq SmallCap Market, was $1.32 and there were
approximately 10,800 holders of record of our common stock. The
number of record holders does not reflect the number of
beneficial owners of our common stock for whom shares are held
by brokerage firms and other institutions. We have not paid any
dividends since our inception and do not contemplate payment of
dividends in the foreseeable future.
|
|
Item 6. |
Selected Financial Data |
The following selected financial data are derived from our
audited financial statements. Our financial statements for 2004
and 2003 have been audited by BDO Seidman, LLP, independent
auditors. Our financial statements for 2002, 2001 and 2000 have
been audited by Ernst & Young LLP, independent
auditors. These historical results do not necessarily indicate
future results. When you read this data, it is important that
you also read our financial statements and related notes, as
well as the section Managements Discussion and
Analysis of Financial Condition and Results of Operations.
14
|
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Statement of Operations Data:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,000 |
|
|
$ |
101,000 |
|
|
$ |
451,000 |
|
|
License fees
|
|
|
428,000 |
|
|
|
94,000 |
|
|
|
1,051,000 |
|
|
|
3,751,000 |
|
|
|
2,000,000 |
|
|
Grant income
|
|
|
|
|
|
|
|
|
|
|
46,000 |
|
|
|
157,000 |
|
|
|
349,000 |
|
|
Other income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$ |
428,000 |
|
|
$ |
94,000 |
|
|
$ |
1,120,000 |
|
|
$ |
4,009,000 |
|
|
$ |
3,025,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(16,392,000 |
) |
|
$ |
(17,845,000 |
) |
|
$ |
(6,176,000 |
) |
|
$ |
(931,000 |
) |
|
$ |
(1,147,000 |
) |
Income from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
799,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(16,392,000 |
) |
|
$ |
(17,845,000 |
) |
|
$ |
(6,176,000 |
) |
|
$ |
(931,000 |
) |
|
$ |
(348,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.12 |
) |
|
Income from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
5,049,000 |
|
|
$ |
12,324,000 |
|
|
$ |
9,284,000 |
|
|
$ |
7,611,000 |
|
|
$ |
6,859,000 |
|
Total stockholders equity
|
|
$ |
1,595,000 |
|
|
$ |
10,193,000 |
|
|
$ |
7,959,000 |
|
|
$ |
6,583,000 |
|
|
$ |
5,619,000 |
|
In January 2005, we completed a $21.3 million private
equity financing in which we issued 17,334,494 shares of
our common stock and warrants to purchase an additional
8,667,247 shares of our common stock at an exercise price
of $2.00 per share. Net of investment banking commissions,
legal, accounting and other fees related to the transaction, we
received proceeds of approximately $19.5 million. The
following selected pro forma balance sheet data is derived from
our balance sheet as of December 31, 2004 and gives effect
to the completion of that private equity financing, but does not
give effect to other events that
15
occurred since December 31, 2004 and thus may not be
indicative of our current financial condition. The information
should be read in conjunction with our balance sheet as of
December 31, 2004 and related notes.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments Related | |
|
|
|
|
Actual as of | |
|
to January 2005 | |
|
Pro Forma as of | |
|
|
December 31, 2004 | |
|
Financing | |
|
December 31, 2004 | |
|
|
| |
|
| |
|
| |
|
|
(Audited) | |
|
(Unaudited) | |
|
(Unaudited) | |
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and short-term investments
|
|
$ |
2,999,000 |
|
|
$ |
19,505,000 |
|
|
$ |
22,504,000 |
|
|
Prepaid and other current assets
|
|
|
956,000 |
|
|
|
|
|
|
|
956,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
3,955,000 |
|
|
|
19,505,000 |
|
|
|
23,460,000 |
|
Non-current assets
|
|
|
1,093,000 |
|
|
|
|
|
|
|
1,093,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
5,048,000 |
|
|
$ |
19,505,000 |
|
|
$ |
24,553,000 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Total liabilities
|
|
$ |
3,283,000 |
|
|
$ |
|
|
|
$ |
3,283,000 |
|
|
|
|
|
|
|
|
|
|
|
Minority interest in subsidiary
|
|
|
170,000 |
|
|
|
|
|
|
|
170,000 |
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.01 par value, 5,000,000 shares
authorized, including 5,000 shares of Series A Junior
Participating Preferred Stock; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value, 100,000,000 shares
authorized; 40,190,000 shares issued at December 31,
2004
|
|
|
40,000 |
|
|
|
17,000 |
|
|
|
57,000 |
|
Additional paid-in-capital
|
|
|
110,028,000 |
|
|
|
19,488,000 |
|
|
|
129,516,000 |
|
Treasury stock, at cost (633,816 shares)
|
|
|
(2,279,000 |
) |
|
|
|
|
|
|
(2,279,000 |
) |
Accumulated deficit
|
|
|
(106,194,000 |
) |
|
|
|
|
|
|
(106,194,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,595,000 |
|
|
|
19,505,000 |
|
|
|
21,100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
5,048,000 |
|
|
$ |
19,505,000 |
|
|
$ |
24,553,000 |
|
|
|
|
|
|
|
|
|
|
|
Factors Affecting Comparability
In the fourth quarter of 2004, we completed our acquisition of
all of the clinical, pharmaceutical and related intellectual
property assets of Biorex, a Hungary-based company focused on
the development of novel small molecules with broad therapeutic
applications in neurology, diabetes and cardiology. We paid
Biorex $3.0 million in cash for the assets at the closing,
and incurred approximately $500,000 in expenses related to the
transaction.
The assets acquired from Biorex include three drug candidates
that had completed the equivalent of a Phase I clinical
trial. We intend to perform additional testing on those drug
candidates, and expect to initiate a Phase II clinical
trial for one of the drug candidates, arimoclomol, for ALS in
the second quarter of 2005. In addition, we acquired a
500-compound molecular library, which we plan to use in high
throughput screening at our obesity and diabetes laboratory.
With the assistance of an outside appraiser, we evaluated the
technology assets acquired from Biorex, including their current
state of development, the severability of the assets, and
16
alternative uses of the compounds. Based in part on that
appraisal, we concluded that the $3.0 million value
allocated to the three drug candidates should be written off at
the time of acquisition as in-process research and development,
and that the $500,000 value attributable to the 500-compound
molecular library should be included in our fixed assets at
December 31, 2004.
In the third quarter of 2003, we recorded an impairment charge
of $5.9 million related to our investments in
Blizzards acquired developed technology and in Psynomics,
based upon our analysis of the recoverability of the carrying
amount of these assets in accordance with the Accounting
Principles Board Opinion No. 18, The Equity Method of
Accounting for Investments in Common Stock. This impairment
charge represented the total net book value of these assets at
the time of the write-off. See Note 12 to our audited
financial statements.
In 2002, we recorded an impairment charge of $921,000 related to
certain equipment and leasehold improvements based on our
evaluation of the recoverability of the carrying amount of those
assets in accordance with the Financial Accounting Standards
Board, or FASB, Statement of Financial Accounting Standards
No. 144 Accounting for the Impairment or
Disposal of Long-Lived Assets. This impairment charge
represented the total net book value of those assets. See
Note 6 to our audited financial statements.
During 2002, we recorded a loss of $478,000 associated with the
closure of our Atlanta headquarters and relocation to Los
Angeles subsequent to our merger with Global Genomics. This loss
represents the total remaining lease obligations and estimated
operating costs through the remainder of the lease, which
expires in 2008, less estimated sublease income. This accrued
charge was combined with deferred rent of $85,000 already
recorded, so that the total accrual related to the facility
abandonment was $563,000 as of December 31, 2002. To the
extent that we are able to negotiate a termination of the
Atlanta lease, our operating costs are different or our
estimates related to sublease income are different, the total
loss ultimately recognized may be different than the amount
recorded as of December 31, 2002 and such difference may be
material. As of December 31, 2004 and 2003, we had
remaining lease closure accruals of $312,000 and $418,000,
respectively.
Pursuant to his employment agreement, our former President and
Chief Executive Officer, Jack Luchese, was entitled to a payment
of $435,000 upon the execution of the merger agreement between
Global Genomics and us and an additional $435,000 upon the
closing of the merger. In order to reduce the amount of cash
that we had to pay Mr. Luchese, Mr. Luchese and we
agreed that approximately $325,000 of the first $435,000 payment
would be satisfied by our grant to Mr. Luchese under our
2000 Long-Term Incentive Plan pursuant of an award of
558,060 shares of our common stock. Those shares of stock
were issued at a value equal to 85% of the volume weighted
average price of our common stock for the 20 trading days ended
on February 8, 2002. The cash payment and fair value of the
shares issued were recognized as expense (total of $428,000)
during the first quarter of 2002.
The terms of our merger with Global Genomics contemplated that
its management team would replace ours subsequent to the closing
of the merger. On July 16, 2002, we terminated the
employment of all of our then-current officers, resulting in
total obligations for severance, stay bonuses, accrued vacation
and other contractual payments of $1.4 million (including
the final $435,000 owed to Mr. Luchese as discussed above).
Prior to the merger closing date, we advanced part of these
amounts to three of our officers (through salary continuance),
such that the total remaining obligation at the closing date was
$1.2 million. Four of our officers agreed to accept an
aggregate total of $177,000 of this amount in the form of our
common stock, in lieu of cash, resulting in the issuance of
248,799 shares. Thus, the net cash payout in satisfaction
of these obligations was $1.0 million, before taxes. The
severance payments and fair value of the shares issued (total
expense of $1.4 million) were recognized as expense during
the third quarter of 2002 and reported as a separate line item
on the accompanying consolidated statement of operations,
together with the final payment to Mr. Luchese discussed
above.
License fees for 2002 include a $1.0 million milestone
payment received from Merck related to the commencement by Merck
of a Phase I human clinical trial incorporating our
TranzFect technology.
17
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
The following discussion and analysis of our financial condition
and results of operations should be read together with the
discussion under Selected Financial Data and our
consolidated financial statements included in this Annual
Report. This discussion contains forward-looking statements,
based on current expectations and related to future events and
our future financial performance, that involve risks and
uncertainties. Our actual results may differ materially from
those anticipated in these forward-looking statements as a
result of many important factors, including those set forth
under Risk Factors and elsewhere in this Annual
Report.
Overview
We are in the process of developing products, primarily in the
areas of small molecule therapeutics and ribonucleic acid
interference, or RNAi, for the human health care market. RNAi is
a new technology for silencing genes in living cells and
organisms. Development work on RNAi is still at an early stage,
and we are aware of only two clinical tests of medical
applications using RNAi that have yet been initiated by any
party. Our small molecule therapeutics efforts include our
clinical development of three, oral drug candidates that we
acquired in October 2004, as well as our drug discovery
operations conducted at CytRx Laboratories. In addition to our
work in RNAi and small molecule therapeutics, we are involved in
the development of a DNA-based HIV vaccine and have entered into
strategic alliances with respect to the development of several
other products using our other technologies.
Subsequent to our merger with Global Genomics, in July 2002, we
modified our business strategy by discontinuing any further
research and development efforts for our pre-merger
pharmaceutical technologies and began to seek strategic
relationships with other pharmaceutical companies to complete
the development of those technologies. Instead of continuing
research and development for those technologies, we focused our
efforts on acquiring new technologies and products to serve as
the foundation for the future of the company.
In April 2003, we acquired our first new technologies by
entering into exclusive license agreements with the University
of Massachusetts Medical School, or UMMS, covering potential
applications for its proprietary RNAi technology in the
treatment of specified diseases. At that time, we also acquired
an exclusive license from UMMS covering its proprietary
technology with potential gene therapy applications within the
area of cancer. In May 2003, we broadened our strategic alliance
with UMMS by acquiring an exclusive license from it covering a
proprietary DNA-based HIV vaccine technology. In July 2004, we
further expanded our strategic alliance with UMMS by entering
into a collaboration and invention disclosure agreement with
UMMS under which UMMS will disclose to us certain new
technologies developed at UMMS over the next three years
pertaining to RNAi, diabetes, obesity, neurodegenerative
diseases (including amyotrophic lateral sclerosis, also known as
Lou Gehrigs disease or ALS) and cytomegalovirus, or CMV,
and will give us an option, upon making a specified payment, to
negotiate an exclusive worldwide license to the disclosed
technologies on commercially reasonable terms.
As part of our strategic alliance with UMMS, we agreed to fund
certain discovery and pre-clinical research at the medical
school relating to the use of our technologies, licensed from
UMMS, for the development of therapeutic products within certain
fields. Although we intend to internally fund the early stage
development work for certain product applications (including
obesity, type 2 diabetes and ALS) and may seek to fund the
completion of the development of certain of these product
applications (such as ALS), we may also seek to secure strategic
alliances or license agreements with larger pharmaceutical
companies to fund the early stage development work for other
gene silencing product applications and for subsequent
development of those potential products where we fund the early
stage development work.
On October 4, 2004, we acquired all of the clinical and
pharmaceutical and related intellectual property assets of
Biorex Research & Development, RT, or Biorex, a
Hungary-based company focused on the development of novel small
molecules with broad therapeutic applications in neurology,
diabetes and cardiology. The acquired assets include three oral,
clinical stage drug candidates and a library of 500 small
molecule drug candidates. The acquisition positions us as a
clinical-stage company, as we expect to initiate a Phase II
trial for ALS with one of our new drug candidates, arimoclomol,
in the second quarter of 2005.
18
We have not achieved profitability on a quarterly or annual
basis and we expect to continue to incur significant additional
losses over the next several years. Our net losses may increase
from current levels primarily due to activities related to our
collaborations, technology acquisitions, research and
development programs and other general corporate activities. We
anticipate that our operating results will fluctuate for the
foreseeable future. Therefore, period-to-period comparisons
should not be relied upon as predictive of the results in future
periods.
To date, we have relied primarily upon the sale of equity
securities and, to a lesser extent, upon payments from our
strategic partners and licensees to generate the funds needed to
finance the implementation of our business plans. We will be
required to obtain additional funding in order to execute our
long-term business plans. Our sources of potential funding for
the next several years are expected to consist primarily of
proceeds from sales of equity, but could also include license
and other fees, funded research and development payments, and
milestone payments under existing and future collaborative
arrangements.
Research and Development
Following our 2003 acquisition of rights from UMMS to the new
technologies, we initiated research and development programs for
products based upon those technologies. Expenditures for
research and development activities related to continuing
operations were $9.0 million, $4.4 million and
$767,000 for the years ended December 31, 2004, 2003 and
2002, respectively, with research and development expenses
representing approximately 53%, 39% and 11% of our total
expenses for the years ended December 31, 2004, 2003 and
2002, respectively. Included in research and development
expenses for 2004 was $3.0 million of in-process research
and development that was written off in conjunction with our
acquisition of assets from Biorex. Research and development
expenses are further discussed below under Critical
Accounting Policies and Estimates and Results of
Operations.
In September 2003, we purchased 95% of CytRx Laboratories, Inc.
(formerly known as Araios, Inc.), our research and development
subsidiary, which had been recently formed to develop orally
active small molecule-based drugs for the prevention, treatment
and cure of obesity and type 2 diabetes. Utilizing the RNAi
technology that we have licensed from UMMS, in combination with
state of the art target identification methods, our subsidiary
will focus on using a genomic and proteomic based drug discovery
approach to accelerate the process of screening and identifying
potential drug targets and pathways for these diseases to
discover and develop molecular based medicines for the treatment
of obesity and type 2 diabetes. We provided our subsidiary in
September 2003 with initial capital of approximately $7,000,000
to fund the staffing of its operations with managerial and
scientific personnel and its initial drug development activities.
In October 2004, we acquired all of the clinical, pharmaceutical
and related intellectual property assets of Biorex, a company
focused on the development of novel small molecules with broad
therapeutic applications in neurology, diabetes and cardiology.
The acquired assets include three oral, clinical stage drug
candidates and a library of 500 small molecule drug candidates.
We expect to initiate a Phase II trial for ALS with one of
the compounds, arimoclomol, in the second quarter of 2005, and
estimate that the Phase II trial will require us to expend
approximately $5.5 million over a period of twelve to
eighteen months, which includes a $500,000 milestone
payment that may become payable to Biorex under certain
circumstances.
There is a risk that any drug discovery and development program
may not produce revenue because of the risks inherent in drug
discovery and development. Moreover, there are uncertainties
specific to any new field of drug discovery, including RNAi. The
successful development of any product candidate we develop is
highly uncertain. We cannot reasonably estimate or know the
nature, timing and costs of the efforts necessary to complete
the development of, or the period in which material net cash
inflows are expected to commence from any product candidate, due
to the numerous risks and uncertainties associated with
developing drugs, including the uncertainty of:
|
|
|
|
|
Our ability to advance product candidates into pre-clinical and
clinical trials. |
|
|
|
The scope, rate and progress of our pre-clinical trials and
other research and development activities. |
|
|
|
The scope, rate of progress and cost of any clinical trials we
commence. |
19
|
|
|
|
|
The cost of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights. |
|
|
|
Future clinical trial results. |
|
|
|
The terms and timing of any collaborative, licensing and other
arrangements that we may establish. |
|
|
|
The cost and timing of regulatory approvals. |
|
|
|
The cost and timing of establishing sales, marketing and
distribution capabilities. |
|
|
|
The cost of establishing clinical and commercial supplies of our
product candidates and any products that we may develop. |
|
|
|
The effect of competing technological and market developments. |
Any failure to complete any stage of the development of our
products in a timely manner could have a material adverse effect
on our operations, financial position and liquidity. A
discussion of the risks and uncertainties associated with
completing our projects on schedule, or at all, and the
potential consequences of failing to do so, are set forth in the
Risk Factors section of this Annual Report.
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial
condition and results of operations are based on 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 management 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, management evaluates its
estimates, including those related to revenue recognition, bad
debts, impairment of long-lived assets, including finite lived
intangible assets, accrued liabilities and certain expenses. 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 materially from these estimates under different
assumptions or conditions.
Our significant accounting policies are summarized in
Note 2 to our audited financial statements. We believe the
following critical accounting policies affect our more
significant judgments and estimates used in the preparation of
our consolidated financial statements:
Nonrefundable license fee revenue is recognized when
collectibility is reasonably assured, which is generally upon
receipt, when no continuing involvement on our part is required
and payment of the license fee represents the culmination of the
earnings process. Nonrefundable license fees received subject to
future performance by us, or that are credited against future
payments due to us are deferred and recognized as services are
performed and collectibility is reasonably assured, which is
generally upon receipt, or upon termination of the agreement and
all related obligations thereunder, whichever is earlier. Our
revenue recognition policy may require us in the future to defer
significant amounts of revenue.
|
|
|
Research and Development Expenses |
Research and development expenses consist of costs incurred for
direct and overhead-related research expenses and are expensed
as incurred. Costs to acquire technologies which are utilized in
research and development and which have no alternative future
use are expensed when incurred. Technology developed for use in
our products is expensed as incurred, until technological
feasibility has been established. Expenditures, to date, have
been classified as research and development expense in the
consolidated statements of operations and we expect to continue
to expense research and development for the foreseeable future.
20
We grant stock options and warrants for a fixed number of shares
to key employees and directors with an exercise price equal to
the fair market value of the shares at the date of grant. We
account for stock option grants and warrants in accordance with
APB Opinion No. 25, Accounting for Stock Issued to
Employees (APB 25) and related interpretations and,
accordingly, recognize no compensation expense for the stock
option grants and warrants issued to employees and directors for
which the terms are fixed.
For stock option grants and warrants which vest based on certain
corporate performance criteria, compensation expense is
recognized to the extent that the market price per share exceeds
the exercise price on the date such criteria are achieved or are
probable. At each reporting period end, we must estimate the
probability of the criteria specified in the stock based awards
being met. Different assumptions in assessing this probability
could result in additional compensation expense being recognized.
In October 1995, the FASB issued Statement of Financial
Accounting Standards No. 123, Accounting for Stock-based
Compensation (SFAS 123), which provides an alternative
to APB 25 in accounting for stock-based compensation issued
to employees. However, we have continued to account for
stock-based compensation in accordance with APB 25. See
Notes 2 and 14 to our audited financial statements.
We have also granted stock options and warrants to certain
consultants and other third parties. Common stock, stock options
and warrants granted to consultants and other third parties are
accounted for in accordance with SFAS 123 and related
interpretations and are valued at the fair market value of the
common stock, options and warrants granted, as of the date of
grant or services received, whichever is more reliably
measurable. Expense is recognized in the period in which a
performance commitment exists or the period in which the
services are received, whichever is earlier. We anticipate that
we will continue to rely on the use of consultants and that we
will be required to expense the associated costs. We anticipate
continuing the use of stock options to compensate employees,
directors and consultants, and continuing to expense the options
in accordance with APB 25.
|
|
|
Impairment of Long-Lived Assets |
We review long-lived assets, including finite lived intangible
assets, for impairment on an annual basis, as of
December 31, or on an interim basis if an event occurs that
might reduce the fair value of such assets below their carrying
values. An impairment loss would be recognized based on the
difference between the carrying value of the asset and its
estimated fair value, which would be determined based on either
discounted future cash flows or other appropriate fair value
methods.
In 2002, we recorded an impairment charge of $921,000 related to
certain equipment and leasehold improvements based on our
evaluation of the recoverability of the carrying amount of these
assets in accordance with the FASB Statement of Financial
Accounting Standards No. 144 Accounting for
the Impairment or Disposal of Long-Lived Assets
(SFAS 144). This impairment charge represented the
total net book value of these assets. See Note 6 to our
audited financial statements.
In accordance with the provisions of Accounting Principles Board
Opinion No. 18, The Equity Method of Accounting for
Investments in Common Stock (APB 18), we reviewed the
net values on our balance sheet, as of September 30, 2003,
assigned to Investment in Minority Owned
Entity Acquired Developed Technology resulting from
our acquisition of Blizzard Research and Development Company, or
Blizzard. Blizzard was recorded as an acquired development-stage
company and there was an external valuation used for
substantiation of the value of the technology and the
investment, which was prepared as of the date of the
announcement of the transaction February 11, 2002. For our
annual audit of fiscal 2002, potential impairment was addressed
and the valuation was updated internally using similar methods
used for the original investment. Based upon our analysis there
was no impairment. Our auditors for that fiscal year concurred.
We continued to measure impairment through these methods on a
quarterly basis and through the second quarter of 2003, we
continued to believe that Blizzards proprietary technology
was commercially viable, subject to its ability to obtain
significant financing. At that time we believed there was no
impairment. APB 18 requires that a loss in value of an
investment, which is other than a temporary decline, should be
recognized as an impairment loss.
21
Through the third quarter of 2003, Blizzard had been
unsuccessful in its attempts to raise a significant amount of
financing necessary for it to pursue its commercialization
strategy for its products and we subsequently decided not to
further invest in this entity. We believe that Blizzard was
unable to obtain substantial third-party financing primarily
because (1) the genomics market, which the Blizzard
technology was targeting, had begun to decline in 2003,
(2) Blizzard had not completed a production unit of its
principal product for testing by potential investors, and
(3) certain investors were unwilling to invest without a
simultaneous infusion of additional capital from us as
Blizzards 40% shareholder, and we were unable to reach
satisfactory terms for such financing. Our analysis consisted of
a review of the financial projections prepared by Blizzard,
application of a discounted cash flow valuation model of
Blizzards projected cash flows, and consideration of other
qualitative factors such as Blizzards termination of its
employees, its office lease and its engagement of its investment
banker. Based upon the quantitative and qualitative factors
described above, in addition to others, our management
determined that the estimated fair value of our investment in
Blizzard was $0 and that an impairment charge of
$5.9 million was necessary. In considering the timing of
the write-off, we looked to Blizzards termination of its
employees, lease and investment banker in October 2003 as
affirmation of conditions that existed at September 2003, and
therefore recorded the write-off in the third quarter of 2003.
The write-off had no impact upon our cash or working capital
position. It is our understanding that, by the end of 2003,
Blizzard had ceased operations and was in the process of
returning its licensed intellectual property to the University
of Minnesota.
|
|
|
Estimated Facility Abandonment Accrual |
During 2002, we recorded a loss of $478,000 associated with the
closure of our Atlanta headquarters and relocation to Los
Angeles, subsequent to our merger with Global Genomics. This
loss represents the total remaining lease obligations and
estimated operating costs through the remainder of the lease
term, less estimated sublease income. This accrued charge was
combined with deferred rent of $85,000 already recorded, so that
the total accrual related to the facility abandonment was
$563,000 as of December 31, 2002. As of December 31,
2004, we had a remaining lease closure accrual of $312,000. To
the extent that we are able to negotiate a termination of the
Atlanta lease, our operating costs are different or our
estimates related to sublease income are different, the total
loss ultimately recognized may be different than the amount
accrued as of December 31, 2004 and such difference may be
material.
Quarterly Financial Data
The following table sets forth unaudited statement of operations
data for our most recent two completed fiscal years. This
quarterly information has been derived from our unaudited
financial statements and, in the opinion of management, includes
all adjustments, consisting only of normal recurring
adjustments, necessary for a fair presentation of the
information for the periods covered. The quarterly financial
data should be read in conjunction with our financial statements
and related notes. The operating results for any quarter are not
necessarily indicative of the operating results for any future
period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended | |
|
|
| |
|
|
March 31 | |
|
June 30 | |
|
September 30 | |
|
December 31 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$ |
100 |
|
|
$ |
228 |
|
|
$ |
|
|
|
$ |
100 |
|
Net loss
|
|
|
(3,774 |
) |
|
|
(4,061 |
) |
|
|
(2,796 |
) |
|
|
(5,761 |
) |
Basic and diluted loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(0.11 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
1 |
|
|
$ |
90 |
|
Net loss
|
|
|
(914 |
) |
|
|
(5,046 |
) |
|
|
(8,777 |
) |
|
|
(3,108 |
) |
Basic and diluted loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(0.04 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.09 |
) |
22
Quarterly and year to date loss per share amounts are computed
independently of each other. Therefore, the sum of the per share
amounts for the quarters may not agree to the per share amounts
for the year.
Liquidity and Capital Resources
At December 31, 2004, we had cash, cash equivalents and
short-term investments of $3.0 million and total assets of
$5.0 million compared to $11.6 million and
$12.3 million, respectively, at December 31, 2003.
Working capital totaled $1.2 million at December 31,
2004, compared to $10.8 million at December 31, 2003.
To date, we have relied primarily upon selling equity securities
and, to a lesser extent, upon payments from our strategic
partners and licensees to generate funds needed to finance the
implementation of our plans of operations. As a result of the
$21.3 million equity financing that we completed in January
2005, we believe that our cash and short-term investments
balances will be sufficient to meet our cash requirements into
the second quarter of 2006. We nonetheless will be required to
obtain significant additional funding in order to execute our
business plans. We cannot assure that additional funding will be
available on favorable terms, if at all. If we fail to obtain
additional funding when needed, we may not be able to execute
our business plan and our business prospects may suffer, which
could have a material adverse effect on our ability to become
profitable.
Net cash used in operating activities for the year ended
December 31, 2004 was $12.4 million, compared to net
cash used in operating activities of $4.3 million in 2003
and $3.5 million in 2002. Revenues earned and received
during 2004, 2003 and 2002 were $428,000, $94,000 and
$1.1 million respectively. These revenues have been
insignificant in relation to our ongoing expenses and arise from
our licensing of our Tranzfect technology, which we no longer
consider part of our core drug discovery and development
strategy. Future revenues from these licenses are dependent upon
the licensee successfully reaching certain development
milestones. We do not expect any significant revenues from these
licensing agreements in 2005.
Our net loss for the year ended December 31, 2004 was
$16.4 million, which includes the write-off of
$3.0 million of in-process research and development related
to the acquisition of assets from Biorex. The $16.4 million
loss resulted in net cash used in operating activities of
$12.4 million. Adjustments to reconcile net loss to net
cash used in operating activities for the year ended
December 31, 2004 were primarily $873,000 of common stock,
options and warrants issued in lieu of cash for selling, general
and administrative services. Additionally, we issued $388,000 of
common stock, options and warrants in lieu of cash in connection
with certain license fees and $1.0 million in connection
with research and development activities. Our net loss for the
year-ended December 31, 2003 was $17.8 million, which
resulted in net cash used in operating activities of
$4.3 million. Adjustments to reconcile net loss to net cash
used in operating activities for the year ended
December 31, 2003 were primarily $6.7 million of
losses from a minority-owned entity, $1.5 million of common
stock, options and warrants issued in lieu of cash for selling,
general and administrative services, $1.8 million of common
stock issued in connection with certain license agreements and
$1.1 million of common stock issued in connection with
research and development activities.
In the year ended December 31, 2004, net cash used in
investing activities consisted of $962,000 for the purchase of
securities to be held to maturity and $772,000 for property and
equipment, which includes $447,000 related to assets acquired in
connection with the molecular library assets of Biorex. The
remaining fixed assets acquired relate primarily to laboratory
equipment for CytRx Laboratories. We expect capital spending to
remain at current levels for fiscal 2005. Net cash provided by
investing activities for the year ended December 31, 2003
was $1.2 million, compared to net cash used in investing
activities of $2.0 million in 2002. The change was
primarily due to the purchase, in 2002, of held-to-maturity
investments, which subsequently matured in 2003, an increase in
fixed asset purchases in 2003, as compared to 2002 and the
absence of acquisition costs in 2003, as compared to 2002.
Net cash provided by financing activities in the year ended
December 31, 2004 was $4.4 million. The cash provided
was the result of $430,000 received upon the exercise of stock
options and warrants and the $4.0 million private equity
financing in October 2004. Net cash provided by financing
activities for the year ended December 31, 2003 was
$14.4 million, compared to net cash provided by financing
activities of $628,000 in 2002. In May and September 2003, we
completed private equity financings raising net proceeds of
23
$4.9 million and $7.7 million, respectively. For the
year ended December 31, 2003, we also received proceeds
from the exercise of stock options and warrants totaling
$1.9 million. Cash provided by financing activities in 2002
was comprised primarily of the exercise of stock options and
warrants.
Based on our internal projections of expected expenses, we
believe that we will have adequate working capital to allow us
to operate at our currently planned levels into the second
quarter of 2006. Our strategic alliance with UMMS may require us
to make significant expenditures to fund research at UMMS
relating to developing therapeutic products based on UMMSs
proprietary gene silencing technology that has been licensed to
us. The aggregate amount of these expenditures was approximately
$2.0 million during 2004, and is expected under certain
circumstances to be approximately $2.4 million during 2005.
We will require additional capital in order to fund ongoing
research and development related to the drug candidates acquired
from Biorex in October 2004. We expect to initiate a
Phase II trial for ALS with one of the compounds,
arimoclomol, in the second quarter of 2005, and estimate that
the Phase II trial will require us to expend approximately
$5.5 million over a period of twelve to eighteen months,
including milestone payments of $500,000 that may become payable
to Biorex under certain circumstances. We also may require
additional working capital in order to fund any product
acquisitions that we consummate.
Potential strategic alliance partners or licensees of our
technologies may be a source of future capital. The results of
our technology licensing efforts and the actual proceeds of any
fund-raising activities will determine our ongoing ability to
operate as a going concern. Our ability to obtain future
financings through joint ventures, product licensing
arrangements, equity financings or otherwise is subject to
market conditions and our ability to identify parties that are
willing and able to enter into such arrangements on terms that
are satisfactory to us. There can be no assurance that we will
be able to obtain future financing from these sources.
We expect to incur significant losses for the foreseeable future
and there can be no assurance that we will become profitable.
Even if we become profitable, we may not be able to sustain that
profitability.
The above statements regarding our plans and expectations for
future financing are forward-looking statements that are subject
to a number of risks and uncertainties. Our ability to obtain
future financings through joint ventures, product licensing
arrangements, equity financings or otherwise is subject to
market conditions and our ability to identify parties that are
willing and able to enter into such arrangements on terms that
are satisfactory to us. There can be no assurance that we will
be able to obtain future financing from these sources.
Additionally, depending upon the outcome of our fund raising
efforts, the accompanying financial information may not
necessarily be indicative of future operating results or future
financial condition.
We have no current commitments for capital expenditures in 2005;
however, we anticipate incurring capital expenditures in
connection with the expansion of our subsidiarys
laboratory. We have no committed lines of credit or other
committed funding or long-term debt. As of December 31,
2004, minimum annual future obligations for operating leases,
minimum annual future obligations under various license
agreements and minimum annual future obligations under
employment agreements consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating | |
|
License | |
|
Employment | |
|
|
|
|
Leases | |
|
Agreements | |
|
Agreements | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(In thousands) | |
|
|
2005
|
|
$ |
573 |
|
|
$ |
2,363 |
|
|
$ |
1,008 |
|
|
$ |
3,944 |
|
2006
|
|
|
342 |
|
|
|
1,149 |
|
|
|
740 |
|
|
|
2,231 |
|
2007
|
|
|
229 |
|
|
|
226 |
|
|
|
240 |
|
|
|
695 |
|
2008
|
|
|
76 |
|
|
|
330 |
|
|
|
240 |
|
|
|
646 |
|
2009
|
|
|
|
|
|
|
330 |
|
|
|
|
|
|
|
330 |
|
2010 and thereafter
|
|
|
|
|
|
|
990 |
|
|
|
|
|
|
|
990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,220 |
|
|
$ |
5,388 |
|
|
$ |
2,228 |
|
|
$ |
8,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
We have employment agreements with our executive officers, the
terms of which expire at various times through July 2006.
Certain agreements provide for minimum salary levels, which are
subject to increase annually in the Compensation
Committees discretion, as well as for minimum annual
bonuses. The reported commitment for employment agreements
includes, among other things, a total of $1.0 million of
compensation payable to members of our Scientific Advisory Board
through 2008, and a total of $1.2 million of minimum salary
and guaranteed bonuses payable to our executives.
|
|
|
License and Collaboration Agreements |
In April 2003, we acquired new technologies by entering into
exclusive license arrangements with UMMS covering potential
applications of the medical institutions proprietary RNAi
technology in the treatment of specified diseases, including
those within the areas of obesity, type 2 diabetes ALS, CMV and
covering UMMSs proprietary technology with potential gene
therapy applications within the area of cancer. In consideration
of the licenses, we made cash payments to UMMS totaling $186,000
and issued it a total of 1,613,258 shares of our common
stock which were valued, for financial statement purposes, at
$1.5 million. In May 2003, we broadened our strategic
alliance with UMMS by acquiring an exclusive license from that
institution covering a proprietary DNA-based HIV vaccine
technology. In consideration of this license, we made cash
payments to UMMS totaling $18,000 and issued it
215,101 shares of our common stock which were valued, for
financial statement purposes, at $361,000. In July 2004, we
further expanded our strategic alliance with UMMS by entering
into a collaboration and invention disclosure agreement with
UMMS under which UMMS will disclose to us certain new
technologies developed at UMMS over the next three years
pertaining to RNAi, diabetes, obesity, neurodegenerative
diseases (including ALS) and CMV and will give the Company an
option, upon making a specified payment, to negotiate an
exclusive worldwide license to the disclosed technologies on
commercially reasonable terms. As of December 31, 2004, we
have made cash payments to UMMS totaling $187,500 pursuant to
the collaboration agreement with UMMS, but have not yet acquired
or made any payments to acquire any options under that agreement.
In May 2004, we licensed from the technology transfer company of
the Imperial College of Science, Technology & Medicine, or
Imperial College, the exclusive rights to intellectual property
covering a drug screening method using RIP 140, which is a
nuclear hormone co-repressor that is believed to regulate fat
accumulation. In consideration of the license, we made cash
payments to Imperial College totaling $87,000 and issued it a
total of 75,000 shares of our common stock which were
valued, for financial statement purposes, at $108,000. As the
drug screening technology from Imperial College and the RNAi
technology from UMMS had not achieved technological feasibility
at the time of their license by us, had no alternative future
uses and, therefore, no separate economic value, the total value
of all cash payments and stock issued for acquisition of the
technology was expensed as research and development in our
financial statements.
|
|
|
Net Operating Loss Carryforward |
At December 31, 2004, we had consolidated net operating
loss carryforwards for income tax purposes of
$73.7 million, which will expire in 2005 through 2024 if
not utilized. We also have research and development tax credits
and orphan drug tax credits available to reduce income taxes, if
any, of $6.3 million, which will expire in 2005 through
2020 if not utilized. The amount of net operating loss
carryforwards and research tax credits available to reduce
income taxes in any particular year may be limited in certain
circumstances. Based on an assessment of all available evidence
including, but not limited to, our limited operating history in
our core business and lack of profitability, uncertainties of
the commercial viability of our technology, the impact of
government regulation and healthcare reform initiatives, and
other risks normally associated with biotechnology companies, we
have concluded that it is more likely than not that these net
operating loss carryforwards and credits will not be realized
and, as a result, a 100% deferred tax valuation allowance has
been recorded against these assets.
Results of Operations
CytRx Corporation earned revenues of $428,000, $94,000 and
$1.1 million during the years ended 2004, 2003 and 2002,
respectively, primarily from our licensing agreements related to
our Tranzfect technology. All
25
future licensing fees under our current agreements are dependent
upon successful development milestones being achieved by the
licensor. In 2005, we do not anticipate receiving any
significant licensing fees.
In 2002, we received a $46,000 grant from the Small Business
Innovation Research (SBIR) program for domestic small
business concerns to engage in research and development related
to of our Flocor technology. There were no grant revenues in
2004 or 2003, and we do not currently expect to receive SBIR or
other similar grants that would provide us funding in 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Research and development expense
|
|
$ |
4,626 |
|
|
$ |
1,485 |
|
|
$ |
689 |
|
Non-cash research and development expense
|
|
|
1,387 |
|
|
|
2,903 |
|
|
|
|
|
Acquired in-process research and development expense
|
|
|
3,022 |
|
|
|
|
|
|
|
78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9,035 |
|
|
$ |
4,388 |
|
|
$ |
767 |
|
|
|
|
|
|
|
|
|
|
|
Research expenses are expenses incurred by us in the discovery
of new information that will assist us in the creation and the
development of new drugs or treatments. Development expenses are
expenses incurred by us in our efforts to commercialize the
findings generated through our research efforts. Our research
and development expenses were $9.0 million in 2004,
$4.4 million in 2003 and $800,000 in 2002.
Research and development expenses during 2004 were primarily the
result of efforts to develop RNAi through new and existing
licensing agreements, sponsored research agreements, as well as
research and development efforts performed at our obesity and
diabetes subsidiary. Our subsidiary is working to develop small
molecule inhibitors against proprietary protein targets
identified through sponsored research agreements and licensing
of intellectual property. Research and development expenses
incurred in 2003 were primarily for the acquisition and
licensing of intellectual property and the commencement of
operations of our subsidiarys operations. Research and
development expenses in 2002 were primarily related to our
Flocor technology, which was subsequently out-licensed as the
technology no longer fit our strategic direction. Also, included
in research and development expenses in 2002 was a small amount
of in-process research and development expense related to a
former subsidiary.
In October 2004, we acquired all of the clinical and
pharmaceutical and related intellectual property assets of
Biorex, a Hungry-based company focused on the development of
novel small molecules with broad therapeutic applications in
neurology, diabetes and cardiology for approximately
$3.5 million in cash. Included in the assets acquired from
Biorex are a 500-compound molecular library, as well as the
molecules arimoclomol, iroxanadine and bimoclomol, each of which
had, at the time of acquisition, successfully completed the
European equivalent of a Phase I clinical trial. After
managements evaluation of the acquired technology,
approximately $3.0 million was written-off as in-process
research and development.
In 2005, we expect our research and development expenses to
increase primarily as a result of our expected initiation of a
Phase II clinical trial with arimoclomol for the treatment
of ALS in the second quarter of 2005. We estimate that the
Phase II trial will cost approximately $5.5 million
and will last between 12 and 18 months. Additionally, we
estimate that our costs related to the activities of our
subsidiary to increase by approximately $1.0 million in
2005 as the subsidiary expands its research activities.
26
|
|
|
Selling, general and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Common stock, stock options and warrants issued for selling,
general and administrative expense
|
|
$ |
1,977 |
|
|
$ |
3,148 |
|
|
$ |
230 |
|
Selling, general and administrative expense
|
|
|
5,924 |
|
|
|
3,841 |
|
|
|
1,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,901 |
|
|
$ |
6,989 |
|
|
$ |
1,933 |
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses include all administrative
salaries and general corporation expenses. Our general and
administrative expenses were $7.9 million in 2004,
$7.0 million in 2003 and $1.9 million in 2002. The
increase in general and administrative expenses during 2004 as
compared to 2003 is primarily the result of increased audit fees
due to our change in auditors, severance paid to certain members
of management in the first half of 2004, the hiring of
additional executive officers and the settlement of certain
legal proceedings, for which there was no comparable expenses in
2003. The increase in general administrative expenses during
2003 as compared to 2002 is due primarily to our change in our
business strategy, which led to an increase in activity and, as
a result, a greater use of consultants for financial and
business development advisory services.
From time to time, we issue shares of our common stock or
warrants to purchase shares or our common stock to consultants
and other service providers in exchange for services. For
financial statement purposes, we value these shares of common
stock, stock options, and warrants at the fair value of the
common stock, stock options or warrants granted, or the services
received, whichever is more reliably measurable. We recorded
non-cash charges of $2.0 million, $3.1 million and
$200,000 during 2004, 2003 and 2002, respectively. These charges
relate primarily to common stock, stock options and warrants
issued in connection with the engagement and retention of
financial, business development and scientific advisors. The
significant increase in 2003 as compared to 2002 was due
primarily to the change in our business strategy, which led to
greater activity and, as a result, a greater use of consultants,
primarily for financial and business development services.
During 2004, as our business strategy progressed, less use of
financial business advisors was required, which resulted in
substantially fewer options and common stock being issued as
compared to 2003.
Depreciation and amortization expense
Depreciation and amortization expense was $104,000, $2,000 and
$794,000 in 2004, 2003 and 2002 respectively. During the fourth
quarter of 2003 and the first two quarters of 2004, we increased
our capital spending as part of its overall strategy to
establish a laboratory subsidiary. During 2004 capital assets
increased by $668,000 to $895,000, net of depreciation. As a
result of these additions to assets, depreciation related to
capital equipment increased from $2,000 in 2003 to $104,000 in
2004. The $792,000 decrease in depreciation in 2003 as compared
to 2002 was the result of an impairment charge (discussed below)
taken in the fourth quarter of 2002. We anticipate our need for
additional capital equipment will be modest in the future.
|
|
|
Severance and other contractual payments to
officers |
In accordance with a Mutual General Release and Severance
Agreement in May 2004, we agreed to pay our former General
Counsel, approximately $87,500 and 12 months of related
benefits, and agreed to immediately vest options to
purchase 87,500 shares of our common stock that were
granted upon the commencement of his employment. In accordance
with a Mutual General Release and Severance Agreement in May
2004, we agreed to pay our former Chief Financial Officer,
approximately $150,000 and 18 months of related benefits,
and agreed to immediately vest options to
purchase 105,000 shares of our common stock that were
granted upon the commencement of his employment.
Pursuant to his employment agreement, our former President and
CEO, Jack Luchese, was entitled to a payment of $435,000 upon
the execution of the merger agreement between Global Genomics
and us and an additional $435,000 upon the closing of the
merger. In order to reduce the amount of cash that we had to pay
to Mr. Luchese, Mr. Luchese and we agreed that
approximately $325,200 of the first $435,000 payment would
27
be satisfied by CytRx granting a stock award to Mr. Luchese
under our 2000 Long-Term Incentive Plan pursuant to which we
issued Mr. Luchese 558,060 shares of our common stock.
Those shares of stock were issued at a value equal to 85% of the
volume weighted average price of our common stock for the 20
trading days ended on February 8, 2002. The cash payment
and fair value of the shares issued were recognized as expense
(total of $428,000) during the first quarter of 2002.
The terms of our merger with Global Genomics contemplated that
their management team would replace ours subsequent to the
closing of the merger. On July 16, 2002, we terminated the
employment of all of our then current officers, resulting in
total obligations for severance, stay bonuses, accrued vacation
and other contractual payments of $1.4 million (including
the final $435,000 owed to Mr. Luchese as discussed above).
Prior to the merger closing date, we advanced part of these
amounts to three of our officers (through salary continuance),
such that the total remaining obligation at the closing date was
$1.2 million. Four of our officers agreed to accept an
aggregate total of $177,000 of this amount in the form of our
common stock in lieu of cash, resulting in the issuance of
248,799 shares. Thus, the net cash payout in satisfaction
of these obligations was $1.0 million, before taxes. The
severance payments and fair value of the shares issued (total
expense of $1.4 million) was recognized as expense during
the third quarter of 2002 and is reported as a separate line
item on the accompanying consolidated statement of operations,
together with the final payment to Mr. Luchese discussed
above.
Asset impairment charge During the fourth
quarter of 2002, we recognized an asset impairment charge of
approximately $921,000 related to our equipment and facility
used for Flocor production. We recorded an impairment loss equal
to the net book value of the equipment and related leasehold
improvements.
Loss on facility abandonment During the
fourth quarter of 2002, we recognized a loss of $478,000
associated with the closure of our Atlanta headquarters and
relocation to Los Angeles subsequent to our merger with Global
Genomics. This loss represents the difference between the total
remaining lease obligations and estimated operating costs
through the remainder of the lease, which expires in 2008, less
estimated sublease income.
Interest income Interest income was $60,000
in 2004, as compared to $82,000 in 2003 and $96,000 in 2002. The
variances between years are primarily attributable to the cash
available for investment.
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|
Equity Losses from Minority-Owned Entity |
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Year Ended December 31, | |
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|
| |
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|
2004 |
|
2003 | |
|
2002 | |
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| |
|
| |
|
|
(In thousands) | |
Equity losses from minority-owned entity
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|
$ |
|
|
|
$ |
245 |
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|
$ |
330 |
|
Asset impairment charge
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5,869 |
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|
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|
Amortization of acquired developed technology
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|
|
|
|
|
|
548 |
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|
|
335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
6,662 |
|
|
$ |
665 |
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|
|
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|
Blizzard ceased operations at the end of 2003. Prior to that
time, we recorded our portion of the net loss of Blizzard in
accordance with the equity method of accounting. In 2003, we
recorded $6.7 million in equity losses, of which
$5.9 million was an asset impairment charge, $245,000 was
our 40% share of the net loss in Blizzard and $548,000 was
amortization of acquired developed technology. For the period
July 19, 2002 (date of acquisition of Global) to
December 31, 2002, we recorded $665,000 in equity losses,
of which $330,000 was our share in the net losses of Blizzard
Genomics and $335,000 was amortization of acquired developed
technology.
Minority interest in losses of subsidiary We
recorded $160,000 in 2004 and $20,000 in 2003 related to the 5%
minority interest in losses of CytRx Laboratories, which we
acquired in September 2003.
28
Recently Issued Accounting Standards
On December 16, 2004, the Financial Accounting Standards
Board (FASB) issued FASB Statement No. 123 (revised
2004), Share-Based Payment, or SFAS 123(R),
which is a revision of FASB Statement No. 123,
Accounting for Stock-Based Compensation.
SFAS 123(R) supersedes APB Opinion No. 25,
Accounting for Stock Issued to Employees, and amends
FASB Statement No. 95, Statement of Cash Flows.
Generally, the approach in SFAS 123(R) is similar to the
approach described in Statement 123. However,
SFAS 123(R) requires all share-based payments to employees,
including grants of employee stock options, to be recognized in
the statement of operations based on their fair values. Pro
forma disclosure is no longer an alternative.
SFAS 123(R) must be adopted by us for interim periods
beginning after July 1, 2005. Early adoption will be
permitted in periods in which financial statements have not yet
been issued. We expect to adopt SFAS 123(R) on July 1,
2005. SFAS 123(R) permits companies to adopt its
requirements using one of two methods.
The first method is a modified prospective transition method
whereby a company would recognize share-based employee costs
from the beginning of the fiscal period in which the recognition
provisions are first applied as if the fair value-based
accounting method had been used to account for all employee
awards granted, modified, or settled after the effective date
and to any awards that were not fully vested as of the effective
date. Measurement and attribution of compensation cost for
awards that are nonvested as of the effective date of
SFAS 123(R) would be based on the same estimate of the
grant-date fair value and the same attribution method used
previously under SFAS 123.
The second adoption method is a modified retrospective
transition method whereby a company would recognize employee
compensation cost for periods presented prior to the adoption of
SFAS 123(R) in accordance with the original provisions of
SFAS 123, that is, an entity would recognize employee
compensation cost in the amounts reported in the pro forma
disclosures provided in accordance with SFAS 123. A company
would not be permitted to make any changes to those amounts upon
adoption of SFAS 123(R) unless those changes represent a
correction of an error. For periods after the date of adoption
of SFAS 123(R), the modified prospective transition method
described above would be applied.
We currently expect to adopt SFAS 123(R) using the modified
prospective transition method, and expect the adoption to have
an effect on our results of operations similar to the amounts
reported historically in our footnotes (see Note 14 to our
audited financial statements) under the pro forma disclosure
provisions of SFAS 123.
Related Party Transactions
Dr. Michael Czech, a 5% shareholder of our subsidiary (see
Note 19 to our audited financial statements) and a member
of our subsidiarys Scientific Advisory Boards, is an
employee of UMMS and party, as the principal investigator, to a
sponsored research agreement between UMMS and us. As of
December 31, 2004, we recorded a minority interest
liability of $350,000 representing the 5% interest in our
subsidiary held by Dr. Czech. Additionally, we have
recorded the fair value of 300,000 shares of our common
stock as additional paid-in capital for our right to call and
the Dr. Czechs right to put the remaining 5% interest
to us in exchange for a guaranteed amount of 300,000 shares
of our common stock. The fair value of these shares on the
purchase date was approximately $723,000. During 2004 and 2003,
Dr. Czech was paid $171,000 and $18,000, respectively, for
his Scientific Advisory Board services. During each of 2004 and
2003, we paid UMMS $403,000 under a sponsored research agreement
to fund a portion of Dr. Czechs research.
Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing
arrangements, other than operating leases.
29
RISK FACTORS
If any of the following risks actually occur, our business or
prospects could be materially adversely affected. You should
also refer to the other information in this Annual Report,
including our financial statements and the related notes.
We Have Operated at a Loss and Will Likely Continue to
Operate at a Loss For the Foreseeable Future
We have incurred significant losses over the past five years,
including net losses of $16.4 million, $17.8 million
and $6.2 million for the years ended December 31,
2004, 2003 and 2002, respectively, and we had an accumulated
deficit of approximately $106.2 million as of
December 31, 2004. Our operating losses have been due
primarily to our expenditures for research and development on
our products and for general and administrative expenses and our
lack of significant revenues. We are likely to continue to incur
operating losses until such time, if ever, that we generate
significant recurring revenues. Unless we are able to acquire
products from third parties that are already being marketed and
that can be profitably marketed by us, we anticipate it will
take a minimum of three years (and possibly longer) for us to
generate recurring revenues, since we expect that it will take
at least that long before the development of any of our licensed
or other current potential products is completed, marketing
approvals are obtained from the United States Food and Drug
Administration, or FDA, and commercial sales of any of these
products can begin.
We Have No Source of Significant Recurring Revenues, Which
Makes Us Dependent on Financing to Sustain Our Operations
Our revenues were $428,000, $94,000 and $1.1 million during
the years ended December 31, 2004, 2003 and 2002,
respectively. We will not have significant recurring operating
revenues until at least one of the following occurs:
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We are able to complete the development of and commercialize one
or more of the products that we are currently developing, which
may require us to first enter into license or other arrangements
with third parties. |
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One or more of our currently licensed products is commercialized
by our licensees, thereby generating royalty income for us. |
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We are able to acquire products from third parties that are
already being marketed or are approved for marketing. |
We are likely to incur negative cash flow from operations until
such time, if ever, as we can generate significant recurring
revenues. On January 26, 2005, we completed a private
placement financing and received net proceeds of approximately
$19.5 million. Although we believe that we have adequate
financial resources to support our currently planned level of
operations into the second quarter of 2006, it is likely that we
will be dependent on obtaining financing from third parties to
continue to meet our obligations to UMMS, and maintain our
operations, including our planned levels of operations for our
obesity and type 2 diabetes subsidiary and our ongoing research
and development efforts related to the drug candidates acquired
from Biorex. We have no commitments from third parties to
provide us with any additional debt or equity financing.
Accordingly, future financing may be unavailable to us or only
available on terms that substantially dilute our existing
stockholders. A lack of needed financing could force us to
reduce the scope of, or terminate, our operations, or to seek a
merger with or be acquired by another company. There can be no
assurance that we would be able to identify an appropriate
company to merge with or be acquired by or that we could
consummate such a transaction on terms that would be attractive
to our stockholders or at all.
Most of Our Revenues Have Been Generated by License Fees for
TranzFect, Which May Not be a Recurring Source of Revenue for
Us
License fees paid to us with respect to our TranzFect technology
have represented 93%, 81% and 94% of our total revenues for the
years ended December 31, 2004, 2003 and 2002, respectively.
We have already licensed most of the potential applications for
this technology, and there can be no assurance that we will be
30
able to generate additional license fee revenues from any new
licensees for this technology. Our current licensees for
TranzFect, Merck, and Vical, may be required to make further
milestone payments to us under their licenses based on their
future development of products using TranzFect. However, Vical
has only recently commenced two Phase I clinical trials of
products utilizing TranzFect as a component of a vaccine to
prevent CMV. Since TranzFect is to be used as a component in
vaccines, we do not need to seek FDA approval, but any vaccine
manufacturer will need to seek FDA approval for the final
vaccine formulation containing TranzFect. Merck has completed a
multi-center, blinded, placebo controlled Phase I trial of
an HIV vaccine utilizing TranzFect as a component. In the Merck
trials, although the formulation of the tested vaccine using
TranzFect was generally safe, well-tolerated and generated an
immune response, the addition of TranzFect to the vaccine did
not increase this immune response. Moreover, the DNA
single-modality vaccine regimen with TranzFect, when tested in
humans, yielded immune responses that were inferior to those
obtained with the DNA vaccines in macaque monkeys. Accordingly,
there is likely to be a substantial period of time, if ever,
before we receive any further significant payments from Merck or
Vical under their TranzFect licenses.
We Have Changed Our Business Strategy, Which Will Require Us,
in Certain Cases, to Find and Rely Upon Third Parties for the
Development of Our Products and to Provide Us With Products
Following our merger with Global Genomics, we modified our
business strategy of internally developing Flocor and the other,
then-current, potential products that we had not yet licensed to
third parties. Instead, we began to seek to enter into strategic
alliances, license agreements or other collaborative
arrangements with other pharmaceutical companies that would
provide for those companies to be responsible for the
development and marketing of those products. In June 2004, we
licensed Flocor, the primary potential product that we held
prior to the Global Genomics merger and which we had not already
licensed to a third party, to SynthRx, Inc., a recently formed
Houston, Texas-based biopharmaceutical company, under a
strategic alliance that we entered into with that company in
October 2003. Although we intend to internally fund or carry out
a significant portion of the research and development related to
at least one of the drug candidates that we acquired from
Biorex, and, through our subsidiary, the early stage development
work for certain product applications based on the RNAi and
other technologies that we licensed from UMMS, and we may seek
to fund all of the later stage development work for our
potential ALS products, the completion of the development,
manufacture and marketing of these products is likely to
require, in many cases, that we enter into strategic alliances,
license agreements or other collaborative arrangements with
larger pharmaceutical companies for this purpose.
There can be no assurance that our products will have sufficient
potential commercial value to enable us to secure strategic
alliances, license agreements or other collaborative
arrangements with suitable companies on attractive terms or at
all. If we are unable to enter into collaborative agreements, we
may not have the financial or other resources to continue
development of a particular product or the development of any of
our products. In connection with the Phase I clinical trial
currently being conducted by UMMS and ABL on an HIV vaccine
candidate that utilizes a technology that we licensed from UMMS,
we do not have a commercial relationship with the company that
provided an adjuvant for the vaccine for the trial. If we are
not able to enter into an agreement with this company on terms
favorable to us or at all, we may be unable to use some or all
of the results of the clinical trial as part of our clinical
data for obtaining FDA approval of this vaccine, which will
delay the development of the vaccine.
If we enter into these collaborative arrangements, we will be
dependent upon the timeliness and effectiveness of the
development and marketing efforts of our contractual partners.
If these companies do not allocate sufficient personnel and
resources to these efforts or encounter difficulties in
complying with applicable regulatory (including FDA)
requirements, the timing of receipt or amount of revenues from
these arrangements may be materially and adversely affected. By
entering into these arrangements rather than completing the
development and then marketing these products on our own, we may
suffer a reduction in the ultimate overall profitability for us
of these products. In addition, if we are unable to enter into
these arrangements for a particular product, we may be required
to either sell our rights in the product to a third
31
party or abandon it unless we are able to raise sufficient
capital to fund the substantial expenditures necessary for
development and marketing of the product.
We will also seek to acquire products from third parties that
already are being marketed or have previously been marketed. We
have not yet identified any of these products. Even if we do
identify such products, it may be difficult for us to acquire
them with our limited financial resources and, if we acquire
products using our securities as currency, we may incur
substantial shareholder dilution. We do not have any prior
experience in acquiring or marketing products and may need to
find third parties to market these products for us. We may also
seek to acquire products through a merger with one or more
companies that own such products. In any such merger, the owners
of our merger partner could be issued or hold a substantial, or
even controlling, amount of stock in our company or, in the
event that the other company is the surviving company, in that
other company.
Our Current Financial Resources May Limit Our Ability to
Execute Certain Strategic Initiatives
In June 2004, we licensed Flocor to SynthRx, which will be
responsible for developing potential product applications for
Flocor. Although we are not doing any further development work
on TranzFect or Flocor, should our three principal licensees for
those technologies successfully meet the defined milestones, we
could receive future milestone payments and, should any of the
licensees commercialize products based upon our technology,
future royalty payments. However, there can be no assurance that
our licensees will continue to develop or ever commercialize any
products that are based on our Flocor or our TranzFect
technology.
Our strategic alliance with UMMS will require us to make
significant expenditures to fund research at the institution
relating to the development of therapeutic products based on the
UMMS proprietary technologies that we have licensed and pursuant
to our collaboration and invention disclosure agreement with
UMMS. We estimate that the aggregate amount of these
expenditures under our current commitments will be
$2.4 million for 2005, approximately $1.5 million for
2006 and approximately $310,000 for 2007. We have also agreed to
fund approximately $209,000 of sponsored research at
Massachusetts General Hospital during 2005 and 2006. Our license
agreements with UMMS also provide, in certain cases, for
milestone payments based on the progress we make in the clinical
development and marketing of products utilizing the licensed
technologies. In the event that we were to successfully develop
a product in each of the categories of obesity/type 2 diabetes,
ALS, CMV, cancer and an HIV vaccine, under our licenses, those
milestone payments could aggregate up to $16.1 million. In
addition, the agreement pursuant to which we acquired the
clinical and pharmaceutical assets of Biorex provides for
milestone payments based on the occurrence of certain regulatory
filings and approvals related to the acquired products. In the
event that we were to successfully develop any of those
products, the milestone payments could aggregate up to
$4.2 million. Each of the foregoing milestone payments,
however, could vary significantly based upon the milestones we
achieve and the number of products we ultimately undertake to
develop.
Although we believe that an existing grant from the National
Institute of Health, or NIH, will be sufficient to fund
substantially all of the costs of an ongoing Phase I trial
of the HIV vaccine candidate using the technology we licensed
from UMMS and Advanced BioScience Laboratories, or ABL, we could
be required to fund substantial expenses of the trial not
covered by the grant. Under our license for this technology,
following the completion of the current Phase I trial, we
will be responsible for all of the costs for subsequent clinical
trials for this vaccine. The costs of subsequent trials for the
HIV vaccine will be very substantial. We do not have any NIH or
other governmental funding for these future trials, and there
can be no assurance that we will be able to secure such funding
for any of these trials.
The expenditures potentially required under our agreements with
UMMS and ABL, together with the operating capital requirements
of our obesity and type 2 diabetes subsidiary, our planned
sponsored research funding for Massachusetts General Hospital
and our development of the drug candidates acquired from Biorex,
substantially exceed our current financial resources. Although
we raised approximately $19.5 million in January 2005, net
of transaction expenses, those required expenditures will
nonetheless require us to raise additional capital or to secure
a licensee or strategic partner to fulfill our obligations to
UMMS and to develop any products based on the technologies that
we have licensed from UMMS or any products that we acquired
32
from Biorex, and to continue the operations of our subsidiary at
the currently contemplated level. If we are unable to meet our
various financial obligations under license agreements with
UMMS, we could lose all of our rights under those agreements. If
we were to have inadequate financial resources at that time, we
also could be forced to reduce the level of, or discontinue,
operations at our subsidiary.
If Our Products Are Not Successfully Developed and Approved
by the FDA, We May Be Forced to Reduce or Terminate Our
Operations
All of our products are at various stages of development and
must be approved by the FDA or similar foreign governmental
agencies before they can be marketed. The process for obtaining
FDA approval is both time-consuming and costly, with no
certainty of a successful outcome. This process typically
includes the conduct of extensive pre-clinical and clinical
testing, which may take longer or cost more than we or our
licensees anticipate, and may prove unsuccessful due to numerous
factors. Product candidates that may appear to be promising at
early stages of development may not successfully reach the
market for a number of reasons. The results of preclinical and
initial clinical testing of these products may not necessarily
indicate the results that will be obtained from later or more
extensive testing. Companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in
advanced clinical trials, even after obtaining promising results
in earlier trials.
Numerous factors could affect the timing, cost or outcome of our
drug development efforts, including the following:
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Difficulty in securing centers to conduct trials. |
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Difficulty in enrolling patients in conformity with required
protocols or projected timelines. |
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Unexpected adverse reactions by patients in trials. |
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Difficulty in obtaining clinical supplies of the product. |
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Changes in the FDAs requirements for our testing during
the course of that testing. |
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Inability to generate statistically significant data confirming
the efficacy of the product being tested. |
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Modification of the drug during testing. |
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Reallocation of our limited financial and other resources to
other clinical programs. |
It is possible that none of the products we develop will obtain
the appropriate regulatory approvals necessary for us to begin
selling them. The time required to obtain FDA and other
approvals is unpredictable but often can take years following
the commencement of clinical trials, depending upon the
complexity of the drug candidate. Any analysis we perform of
data from clinical activities is subject to confirmation and
interpretation by regulatory authorities, which could delay,
limit or prevent regulatory approval. Any delay or failure in
obtaining required approvals could have a material adverse
effect on our ability to generate revenues from the particular
drug candidate and we may not have the financial resources to
continue to develop our products and may have to terminate our
operations.
The Approach We Are Taking to Discover and Develop Novel
Drugs Using RNAi and Other Technologies is Unproven and May
Never Lead to Marketable Products
The RNAi and other technologies that we have acquired from UMMS
have not yet been clinically tested by us, nor are we aware of
any clinical trials having been completed by third parties
involving similar technologies. Neither we nor any other company
has received regulatory approval to market therapeutics
utilizing RNAi. The scientific discoveries that form the basis
for our efforts to discover and develop new drugs are relatively
new. The scientific evidence to support the feasibility of
developing drugs based on these discoveries is both preliminary
and limited. Successful development of RNAi-based products will
require solving a number of issues, including providing suitable
methods of stabilizing the RNAi drug material and delivering it
into target cells in the human body. We may spend large amounts
of money trying to solve these issues, and never succeed in
doing so. In addition, any compounds that we develop may not
demonstrate in
33
patients the chemical and pharmacological properties ascribed to
them in laboratory studies, and they may interact with human
biological systems in unforeseen, ineffective or harmful ways.
The Drug Candidates Acquired from Biorex May Not Obtain
Regulatory Marketing Approvals
On October 4, 2004, we acquired all of the clinical and
pharmaceutical assets and related intellectual property of
Biorex, including three drug candidates (arimoclomol,
iroxanadine and bimoclomol), and a library of small molecule
drug candidates. Although each of arimoclomol, iroxanadine and
bimoclomol has undergone clinical testing, significant and
costly additional testing will be required in order to bring any
product to market. We may be unable to confirm in our
pre-clinical or clinical trials with arimoclomol, iroxanadine or
bimoclomol the favorable pre-clinical or clinical data
previously generated by European investigators for these drug
candidates, which could require us to have to modify our
development plans for these compounds.
We expect to initiate Phase II clinical testing for
arimoclomol for ALS in the second quarter of 2005, however there
are no assurances that the clinical testing will be successful.
We believe that the FDA may accept the completion of a
successful Phase II clinical trial as sufficient to enable
us to submit a New Drug Application, or NDA, however there are
no guarantees that the FDA will accept our Phase II study
in lieu of a Phase III clinical trial. If the FDA requires
us to complete a Phase III clinical trial, the cost of
development of arimoclomol will increase beyond our estimated
costs. In addition, the FDA ultimately could require us to
achieve an efficacy end point in the clinical trials for
arimoclomol that could be more difficult, expensive and
time-consuming than our planned end point. Although we
anticipate developing arimoclomol for the treatment of ALS,
arimoclomol has also shown therapeutic efficacy in a preclinical
animal model of diabetes and we may pursue development of
arimoclomol for diabetic indications. However, such development
would require significant and costly additional testing. There
is no guarantee that arimoclomol would show any efficacy for any
other indications.
Iroxanadine has been tested in two Phase I clinical trials
and one Phase II clinical trial which showed improvement in
the function of endothelial cells in blood vessels of patients
at risk of cardiovascular disease. We intend to develop this
product to improve endothelial dysfunction in indications such
as diabetic retinopathy and wound healing, which will require
significant and costly additional testing. There is no guarantee
that iroxanadine will show any efficacy in the intended uses we
are seeking. We may also attempt to license iroxanadine to
larger pharmaceutical or biotechnology companies for
cardiovascular indications; however, there is no guarantee that
any such company will be interested in licensing iroxanadine
from us or on terms that are favorable to us.
Bimoclomol has been tested in two Phase II clinical trials
where it was shown to be safe, but where it did not show
efficacy for diabetic neuropathy, the indication for which it
was tested. We intend to develop this compound for other
therapeutic indications, however there can be no guarantee that
this compound will be effective in treating any diseases. In
addition, the FDA may require us to perform new safety clinical
trials, which would be expensive and time consuming and would
delay development of bimoclomol. There is no guarantee that any
additional clinical trials will be successful or that the FDA
will approve any of these products and allow us to begin selling
them in the United States.
Our Obesity and Type 2 Diabetes Subsidiary May Not Be
Able to Develop Products
In order to develop new obesity and type 2 diabetes products,
our subsidiary, CytRx Laboratories, will first need to identify
appropriate drug targets and pathways. We will be using novel
RNAi-based techniques to accelerate this process, but there is
no assurance that these techniques will accelerate our work or
that we will be able to identify highly promising targets or
pathways using these techniques or otherwise. Even if we are
successful in identifying these targets or pathways, we will
need to then develop proprietary molecules that are safe and
effective against these targets. The development process and the
clinical testing of our potential products will take a lengthy
period of time and involve expenditures substantially in excess
of our current financial resources that are available for this
purpose. We currently plan to seek a strategic alliance with a
major pharmaceutical or biotechnology company at a relatively
early stage in our development work to
34
complete the development, clinical testing and manufacturing and
marketing of our obesity and type 2 diabetes products, but we
may not be able to secure such a strategic partner on attractive
terms or at all. We do not have prior experience in operating a
genomic and proteomic-based drug discovery company. Accordingly,
we will be heavily dependent on the prior experience and current
efforts of Dr. Michael P. Czech, the Chairman of the
Scientific Advisory Board of our subsidiary, Dr. Jack
Barber, our Senior Vice President Drug Development,
and Dr. Mark A. Tepper, the President of our subsidiary and
a Vice President of CytRx Corporation, in establishing the
scientific goals and strategies of our subsidiary.
We Will Be Reliant Upon SynthRx to Develop and Commercialize
Flocor
In June 2004, we licensed Flocor and our other co-polymer
technologies to SynthRx and acquired a 19.9% equity interest in
that newly formed biopharmaceutical company. SynthRx has only
limited financial resources and will have to either raise
significant additional capital or secure a licensee or strategic
partner to complete the development and commercialization of
Flocor and these other technologies. We are not aware that
SynthRx has any commitments from third parties to provide the
capital that it will require, and there can be no assurance that
it will be able to obtain this capital or a licensee or
strategic partner on satisfactory terms or at all.
Our prior Phase III clinical trial of Flocor for the
treatment of sickle cell disease patients experiencing an acute
vaso-occlusive crisis did not achieve its primary objective.
However, in this study, for patients 15 years of age or
younger, the number of patients achieving a resolution of crisis
was higher for Flocor-treated patients at all time periods than
for placebo-treated patients, which may indicate that future
clinical trials should focus on juvenile patients. Generating
sufficient data to seek FDA approval for Flocor will require
additional clinical studies which have not yet been funded or
commenced by SynthRx, and those studies will entail substantial
time and expense for SynthRx.
The manufacture of Flocor involves obtaining new raw drug
substance and a supply of the purified drug from the raw drug
substance, which requires specialized equipment. Should SynthRx
encounter difficulty in obtaining the purified drug substance in
sufficient amounts and at acceptable prices, SynthRx may be
unable to complete the development or commercialization of
Flocor on a timely basis or at all.
We Are Unlikely to Recover Any Amounts from Global
Genomics Portfolio Companies
Due to its inability to raise needed capital, Blizzard, which
was Global Genomics principal portfolio company, has been
unable to complete the development of any of its products and
has been notified by the licensor of its core technologies that
it is in default under its license for those technologies.
Global Genomics other portfolio company is at a very early
stage, is operating without any full-time or salaried employees
and has not been able to raise the capital it will need to fund
its planned operations and to acquire licenses to certain
technologies that it will require. Accordingly, it appears
unlikely that either of Global Genomics portfolio
companies will generate revenues for us in the future and, in
2003, we recorded a write-off of the carrying value of our
investments in those companies.
We May Be Involved in Legal Proceedings That Could Affect Our
Business Operations or Financial Condition
We may be involved, from time to time, in investigations and
proceedings by governmental or self-regulatory agencies, certain
of which could result in adverse judgments, fines or other
sanctions. In February 2004, we were notified by the
Massachusetts State Ethics Commission, or the Massachusetts
Commission, that it had initiated a preliminary inquiry into
whether our previous retention of a consultant who introduced us
to UMMS constituted an improper conflict of interest under
Massachusetts ethics laws. UMMS has recently advised us
that it continues to believe that its agreements with us
provided excellent value for UMMS, that it anticipates that the
Massachusetts Commissions review of the terms of those
agreements will confirm that the agreements were fair to UMMS,
and that it believes that the Massachusetts Commission will
concur with the resolution of the conflict proposed by UMMS
under which the consultant will forfeit to UMMS certain of the
compensation that the consultant was to receive from us.
35
We Are Subject to Intense Competition That Could Materially
Impact Our Operating Results
We and our strategic partners or licensees may be unable to
compete successfully against our current or future competitors.
The pharmaceutical, biopharmaceutical and biotechnology industry
is characterized by intense competition and rapid and
significant technological advancements. Many companies, research
institutions and universities are working in a number of areas
similar to our primary fields of interest to develop new
products. There also is intense competition among companies
seeking to acquire products that already are being marketed.
Many of the companies with which we compete have or are likely
to have substantially greater research and product development
capabilities and financial, technical, scientific,
manufacturing, marketing, distribution and other resources than
at least some of our present or future strategic partners or
licensees.
As a result, these competitors may:
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Succeed in developing competitive products sooner than us or our
strategic partners or licensees. |
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Obtain FDA and other regulatory approvals for their products
before approval of any of our products. |
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Obtain patents that block or otherwise inhibit the development
and commercialization of our product candidates. |
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Develop products that are safer or more effective than our
products. |
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Devote greater resources to marketing or selling their products. |
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Introduce or adapt more quickly to new technologies or
scientific advances. |
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Introduce products that render our products obsolete. |
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Withstand price competition more successfully than us or our
strategic partners or licensees. |
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Negotiate third-party strategic alliances or licensing
arrangements more effectively. |
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Take advantage of other opportunities more readily. |
A number of medical institutions and pharmaceutical companies
are seeking to develop products based on gene silencing
technologies. Companies working in this area include Sirna
Therapeutics, Inc., Alnylam Pharmaceuticals, Inc., Benitec Ltd.,
Nucleonics, Inc. and a number of the multinational
pharmaceutical companies. A number of products currently are
being marketed by a variety of the multinational or other
pharmaceutical companies for treating type II diabetes,
including among others the diabetes drugs Avandia® by Glaxo
SmithKline PLC, Actos® by Eli Lilly & Co.,
Glucophage® by Bristol-Myers Squibb Co., Symlin® by
Amylin Pharmaceuticals, Inc. and Starlix® by Novartis and
the obesity drugs Xenical® by F. Hoffman-La Roche Ltd.
and Meridia® by Abbott Laboratories. Many major
pharmaceutical companies are also seeking to develop new
therapies for these disease indications. Companies developing
HIV vaccines that could compete with our HIV vaccine technology
include Merck, VaxGen, Inc., Epimmune, Inc., AlphaVax, Inc. and
Immunitor Corporation.
Currently, Rilutek®, which was developed by Aventis Pharma
AG, is the only drug of which we are aware that has been
approved by the FDA for the treatment of ALS. Other companies
are working to develop pharmaceuticals to treat ALS, including
Aeolus Pharmaceuticals and Oxford BioMedica plc. In addition,
ALS belongs to a family of diseases called neurodegenerative
diseases, which includes Alzheimers, Parkinsons and
Huntingtons disease. Due to similarities between these
diseases, a new treatment for one ailment potentially could be
useful for treating others. There are many companies that are
producing and developing drugs used to treat neurodegenerative
diseases other than ALS, including Amgen, Guilford
Pharmaceuticals, Phytopharm plc, Cephalon, Inc. and Ceregene,
Inc.
Although we do not expect Flocor to have direct competition from
other products currently available or that we are aware of that
are being developed related to Flocors ability to reduce
blood viscosity in the cardiovascular area, there are a number
of anticoagulant products that Flocor would have to compete
against, such as tissue plasminogen activator, or t-PA, and
streptokinase (blood clot dissolving enzymes) as well as
36
blood thinners such as heparin and coumatin, even though Flocor
acts by a different mechanism to prevent damage due to blood
coagulation. In the sickle cell disease area, Flocor would
compete against companies that are developing or marketing other
products to treat sickle cell disease, such as Droxia®
(hydroxyurea) marketed by Bristol-Myers Squibb Co. and
Dacogentm,
which is being developed by SuperGen, Inc. Our TranzFect
technology will compete against a number of companies that have
developed adjuvant products, such as the adjuvant
QS-21tm
marketed by Antigenics, Inc. and adjuvants marketed by Corixa
Corp. Blizzards products, if ever developed, will compete
with a number of currently marketed products, including those
offered by Axon Instruments, Inc., Affymetrix, Inc., Applied
Precision, LLC, Perkin Elmer, Inc. and Agilent Technologies, Inc.
We Do Not Have the Ability to Manufacture Any of Our Products
and Will Need to Rely upon Third Parties for the Manufacture of
Our Clinical and Commercial Product Supplies
We do not currently have the facilities or expertise to
manufacture any of the clinical or commercial supplies of any of
our products. Accordingly, we will be dependent upon contract
manufacturers or our strategic alliance partners to manufacture
these supplies, or we will need to acquire the ability to
manufacture these supplies ourselves, which could be very
difficult, time-consuming and costly. We do not have
manufacturing supply arrangements for our products, including
any of the licensed RNAi technology, the drug candidates
acquired from Biorex or, with the exception of the clinical
supplies for the current Phase I trial, the HIV vaccine
product that utilizes the HIV vaccine technology that we have
licensed from UMMS. There can be no assurance that we will be
able to secure needed manufacturing supply arrangements, or
acquire the ability to manufacture the products ourselves, on
attractive terms or at all. Delays in, or a failure to, secure
these arrangements or abilities could have a materially adverse
effect on our ability to complete the development of our
products or to commercialize them.
We May Be Unable to Protect Our Intellectual Property Rights,
Which Could Adversely Affect the Value of Our Assets
We believe that obtaining and maintaining patent and other
intellectual property rights for our technologies and potential
products is critical to establishing and maintaining the value
of our assets and our business. Although we believe that we have
significant patent coverage for the technologies that we
acquired from Biorex and for our TranzFect technologies, there
can be no assurance that this coverage will be broad enough to
prevent third parties from developing or commercializing similar
or identical technologies, that the validity of our patents will
be upheld if challenged by third parties or that our
technologies will not be deemed to infringe the intellectual
property rights of third parties. We have a nonexclusive license
to a patent owned by UMMS and the Carnegie Institution of
Washington that claims various aspects of gene silencing, or
genetic inhibition by double-stranded RNA, but there can be no
assurance that this patent will withstand possible third-party
challenges or otherwise protect our technologies from
competition. The medical applications of the gene silencing
technology and the other technologies that we have licensed from
the UMMS also are claimed in a number of pending patent
applications, but there can be no assurance that these
applications will result in any issued patents or that those
patents will withstand third-party challenges or protect our
technologies from competition. Moreover, we are aware of at
least one other issued United States patent claiming broad
applications for RNAi, and many patent applications covering
different methods and compositions in the field of RNAi
therapeutics have been and are expected to be filed, and certain
organizations or researchers may hold or seek to obtain patents
that could make it more difficult or impossible for us to
develop products based on the gene silencing technology that we
have licensed. We are aware that at least one of our competitors
is seeking patent coverage in the RNAi field that could restrict
our ability to develop certain RNAi-based therapeutics.
Any litigation brought by us to protect our intellectual
property rights or by third parties asserting intellectual
property rights against us, or challenging our patents, could be
costly and have a material adverse effect on our operating
results or financial condition, make it more difficult for us to
enter into strategic alliances with third parties to develop our
products, or discourage our existing licensees from continuing
their development work on our potential products. If our patent
coverage is insufficient to prevent third parties from
37
developing or commercializing similar or identical technologies,
the value of our assets is likely to be materially and adversely
affected.
We are sponsoring research at UMMS and Massachusetts General
Hospital under agreements that give us certain rights to acquire
licenses to inventions, if any, that arise from that research,
and we may enter into additional research agreements with those
institutions, or others, in the future. We also have a
collaboration and invention disclosure agreement with UMMS under
which UMMS has agreed to disclose to us certain inventions it
makes and to give us an option to negotiate licenses to the
disclosed technologies. There can be no assurance, however, that
any such inventions will arise, that we will be able to acquire
licenses to any inventions under satisfactory terms or at all,
or that any licenses will be useful to us commercially.
We May Incur Substantial Costs from Future Clinical Testing
or Product Liability Claims
If any of our products are alleged to be defective, they may
expose us to claims for personal injury by patients in clinical
trials of our products or by patients using our commercially
marketed products. Even if the commercialization of one or more
of our products is approved by the FDA, users may claim that
such products caused unintended adverse effects. We currently do
not carry product liability insurance covering the use of our
products in human clinical trials or the commercial marketing of
these products. We are in the process of obtaining clinical
trial insurance for our planned clinical trial of arimoclomol
for the treatment of ALS and will seek to obtain such insurance
for any other clinical trials that we conduct, as well as
liability insurance for any products that we market, although
there can be no assurance that we will be able to obtain such
insurance in the amounts we are seeking or at all. We anticipate
that our licensees who are developing our products will carry
liability insurance covering the clinical testing and marketing
of those products. However, if someone asserts a claim against
us and our insurance or the insurance coverage of our licensees
or if their other financial resources are inadequate to cover a
successful claim, such successful claim could have a material
adverse effect on our financial condition or cause us to
discontinue operations. Even if claims asserted against us are
unsuccessful, they may divert managements attention from
our operations and we may have to incur substantial costs to
defend such claims.
We May Be Delisted from the Nasdaq SmallCap Market if Our
Future Filings Are Not Timely
In May 2004, a Nasdaq Listing Qualifications Panel ruled that
our common stock would remain listed on the Nasdaq SmallCap
Market, notwithstanding the fact that we filed our Annual Report
on Form 10-K for the year ended December 31, 2003 with
the SEC after the deadline for its filing. In addition, that
Panel also ruled that our common stock would be delisted if we
failed to timely file any reports with the SEC required for any
period ending on or before June 30, 2005, and that we would
not be entitled to a hearing before a Nasdaq Listing
Qualifications Panel with respect to any finding by
Nasdaqs staff of such a filing deficiency. Our inability
to receive a hearing would make it extremely difficult, if not
impossible, to cure any late filing deficiency. If we fail to
comply with this condition for continued listing and our common
stock is delisted from the Nasdaq Small Cap Market, we may seek
to list our common stock for trading on the American Stock
Exchange or a regional stock exchange or to facilitate trading
of our common stock in the over-the-counter market. If our
common stock is delisted from the Nasdaq SmallCap Market,
however, there is no assurance that our common stock will be
listed for trading elsewhere, and an active trading market for
our common stock may cease to exist and the delisting could
materially and adversely impact the market value of our common
stock.
Our Anti-Takeover Provisions May Make It More Difficult to
Change Our Management or May Discourage Others From Acquiring Us
and Thereby Adversely Affect Stockholder Value
We have a stockholder rights plan and provisions in our bylaws
that may discourage or prevent a person or group from acquiring
us without the approval of our board of directors. The intent of
the stockholder rights plan and our bylaw provisions is to
protect our stockholders interests by encouraging anyone
seeking control of our company to negotiate with our board of
directors.
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We have a classified board of directors, which requires that at
least two stockholder meetings, instead of one, will be required
to effect a change in the majority control of our board of
directors. This provision applies to every election of
directors, not just an election occurring after a change in
control. The classification of our board increases the amount of
time it takes to change majority control of our board of
directors and may cause our potential purchasers to lose
interest in the potential purchase of us, regardless of whether
our purchase would be beneficial to us or our stockholders. The
additional time and cost to change a majority of the members of
our board of directors makes it more difficult and may
discourage our existing stockholders from seeking to change our
existing management in order to change the strategic direction
or operational performance of our company.
Our bylaws provide that directors may only be removed for cause
by the affirmative vote of the holders of at least a majority of
the outstanding shares of our capital stock then entitled to
vote at an election of directors. This provision prevents
stockholders from removing any incumbent director without cause.
Our bylaws also provide that a stockholder must give us at least
120 days notice of a proposal or director nomination that
such stockholder desires to present at any annual meeting or
special meeting of stockholders. Such provision prevents a
stockholder from making a proposal or director nomination at a
stockholder meeting without us having advance notice of that
proposal or director nomination. This could make a change in
control more difficult by providing our directors with more time
to prepare an opposition to a proposed change in control. By
making it more difficult to remove or install new directors, the
foregoing bylaw provisions may also make our existing management
less responsive to the views of our stockholders with respect to
our operations and other issues such as management selection and
management compensation.
Our Outstanding Options and Warrants and the Registrations of
Our Shares Issued in the Global Genomics Merger and Our Recent
Private Financings May Adversely Affect the Trading Price of Our
Common Stock
As of December 31, 2004, there were outstanding stock
options and warrants to purchase approximately 14.5 million
shares of our common stock at exercise prices ranging from $0.01
to $2.94 per share. Our outstanding options and warrants
could adversely affect our ability to obtain future financing or
engage in certain mergers or other transactions, since the
holders of options and warrants can be expected to exercise them
at a time when we may be able to obtain additional capital
through a new offering of securities on terms more favorable to
us than the terms of outstanding options and warrants. For the
life of the options and warrants, the holders have the
opportunity to profit from a rise in the market price of our
common stock without assuming the risk of ownership. To the
extent the trading price of our common stock at the time of
exercise of any such options or warrants exceeds the exercise
price, such exercise will also have a dilutive effect on our
stockholders.
In August 2003, we registered with the SEC for resale by the
holders a total of 14,408,252 shares of our outstanding
common stock and an additional 3,848,870 shares of our
common stock issuable upon exercise of outstanding options and
warrants, which shares and options and warrants were issued
primarily in connection with our merger with Global Genomics and
the $5.4 million private equity financing that we completed
in May 2003. In December 2003, we registered a total of
6,113,448 shares of our common stock, consisting of the
5,175,611 shares issued, or that are issuable upon exercise
of the warrants issued, in connection with the $8.7 million
private equity financing that we completed in September 2003,
and an additional 937,837 shares of our common stock that
we issued, or that are issuable upon the exercise of warrants
that we issued, to certain other third parties. In April 2004,
we became ineligible to continue to use Form S-3 for both
of these registrations, so that the holders of these shares
could no longer sell their shares under these registrations. Our
ineligibility to register resales on Form S-3 may have
created liability under certain of our registration rights
agreements if we are not deemed to have amended certain existing
registrations in a reasonable period of time so as to permit the
holders to again be able to sell their shares under those
registrations. We are in the process of reinstating the
registrations so as to permit the holders to again be able to
sell their shares under these registrations. In November 2004,
we registered 4,000,000 shares of our common stock and an
additional 3,080,000 shares of our common stock issuable
upon the exercise of warrants in connection with the $4,000,000
private equity financing that we completed in October 2004, and
an additional 1,550,000 shares of
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our common stock issued or issuable upon exercise of warrants to
other third parties. In February 2005, we filed with the SEC a
registration statement covering 17,334,494 shares of our
common stock and an additional 9,909,117 shares of our
common stock issuable upon the exercise of warrants in
connection with the $21.3 million private equity financing
that we completed in January 2005. Both the availability for
public resale of these various shares and the actual resale of
these shares could adversely affect the trading price of our
common stock.
We May Issue Preferred Stock in the Future, and the Terms of
the Preferred Stock May Reduce the Value of Our Common Stock
We are authorized to issue up to 5,000,000 shares of
preferred stock in one or more series. Our board of directors
may determine the terms of future preferred stock offerings
without further action by our stockholders. If we issue
preferred stock, it could affect your rights or reduce the value
of our outstanding common stock. In particular, specific rights
granted to future holders of preferred stock may include voting
rights, preferences as to dividends and liquidation, conversion
and redemption rights, sinking fund provisions, and restrictions
on our ability to merge with or sell our assets to a third party.
Changes in Stock Option Accounting Rules May Adversely Impact
Our Reported Operating Results, Our Stock Price and Our
Competitiveness in the Employee Marketplace
In December 2004, the Financial Accounting Standards Board
published new rules that will require companies in 2005 to
record all stock-based employee compensation as an expense. The
new rules apply to stock options grants, as well as a range of
other stock-based compensation arrangements, including
restricted share plans, performance-based awards, share
appreciation rights, and employee share purchase plans. We will
have to apply the new financial accounting rules beginning in
the third quarter of 2005. We have depended in the past upon
compensating our officers, directors, employees and consultants
with such stock-based compensation awards in order to limit our
cash expenditures and to attract and retain officers, directors,
employees and consultants. Accordingly, if we continue to grant
stock options or other stock-based compensation awards to our
officers, directors, employees, and consultants after the new
rules apply to us, our future earnings, if any, will be reduced
(or our future losses will be increased) by the expenses
recorded for those grants. These compensation expenses may be
larger than the compensation expense that we would be required
to record were we able to compensate these persons with cash in
lieu of securities. The expenses we may have to record as a
result of future options grants may be significant and may
materially negatively affect our reported financial results. The
adverse effects that the new accounting rules may have on our
future financial statements should we continue to rely heavily
on stock-based compensation may reduce our stock price and make
it more difficult for us to attract new investors. In addition,
reducing our use of stock plans to reward and incentivize our
officers, directors and employees could result in a competitive
disadvantage to us in the employee marketplace.
We May Experience Volatility in Our Stock Price, Which May
Adversely Affect the Trading Price of Our Common Stock
The market price of our common stock has experienced significant
volatility in the past and may continue to experience
significant volatility from time to time. Our stock price has
ranged from $0.21 to $3.74 per share over the past three
years. Factors such as the following may affect such volatility:
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Our quarterly operating results. |
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Announcements of regulatory developments or technological
innovations by us or our competitors. |
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Government regulation of drug pricing. |
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Developments in patent or other technology ownership rights. |
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Public concern regarding the safety of our products. |
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Other factors which may affect our stock price are general
changes in the economy, financial markets or the pharmaceutical
or biotechnology industries.
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Item 7A. |
Quantitative and Qualitative Disclosures About Market
Risk |
Our exposure to market risk is limited primarily to interest
income sensitivity, which is affected by changes in the general
level of United States interest rates, particularly because a
significant portion of our investments are in short-term debt
securities issued by the U.S. government and institutional
money market funds. The primary objective of our investment
activities is to preserve principal while at the same time
maximizing the income received without significantly increasing
risk. Due to the nature of our short-term investments, we
believe that we are not subject to any material market risk
exposure. We do not have any derivative financial instruments or
foreign currency instruments.
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Item 8. |
Financial Statements and Supplementary Data |
Our consolidated financial statements and supplemental schedule
and notes thereto as of December 31, 2004 and 2003, and for
each of the three years ended December 31, 2004, 2003 and
2002, together with the independent registered public accounting
firms reports thereon, are set forth on pages F-1 to
F-24 of this Annual Report.
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Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
Effective as of January 20, 2004, the Audit Committee of
our board of directors dismissed Ernst & Young LLP, or
E&Y, as our independent auditors. Effective as of
January 30, 2004, our Audit Committee engaged
PricewaterhouseCoopers LLP, or PwC, as our new independent
auditors and to audit our financial statements for the year
ended December 31, 2003. During the years ended
December 31, 2002 and December 31, 2001 and the
subsequent period through January 30, 2004, neither we nor
anyone on our behalf consulted with PwC regarding either
(i) the application of accounting principles to a specified
transaction, either completed or proposed or the type of audit
opinion that might be rendered on our financial statements, and
either a written report was provided to us or oral advice was
provided that PwC concluded was an important factor considered
by us in reaching a decision as to the accounting, auditing or
financial reporting issue; or (ii) any matter that was
either the subject of a disagreement, as that term is defined in
Item 304(a)(1)(iv) of SEC Regulation S-K and the
related instructions thereof, or a reportable event, as that
term is defined in Item 304(a)(1)(v) of SEC
Regulation S-K.
On April 12, 2004, our Audit Committee dismissed PwC as our
independent auditors. PwC was dismissed prior to completing its
audit procedures and did not issue any report on our financial
statements. On April 14, 2004, our Audit Committee engaged
BDO Seidman, LLP, or BDO, which completed its client acceptance
process on that date, to serve as our independent auditors and
to audit our financial statements for the year ended
December 31, 2003. Based on our desire to have the audit of
these financial statements completed in as expeditious a fashion
as possible, our Audit Committee had concluded that it was in
our best interests to dismiss PwC and to engage new independent
accountants to complete the audit of these financial statements.
During the period from January 30, 2004 through
April 12, 2004, there had been no disagreements with PwC on
any matter of accounting principles or practices, financial
statement disclosure, or auditing scope or procedure, which
disagreements if not resolved to the satisfaction of PwC would
have caused it to make reference thereto in its report had it
completed an audit and issued a report on our financial
statements, except as disclosed in the sixth paragraph below. In
addition, for the same period, there had been no reportable
events (as defined in SEC Regulation S-K
Item 304(a)(1)(v)), except as described in the sixth
paragraph below. We recorded all material adjustments that were
communicated to us by PwC during PwCs engagement or to BDO
prior to BDOs engagement.
In our Current Report on Form 8-K filed with the SEC on
April 1, 2004, we indicated that we were reviewing, with
the assistance of PwC, the accounting treatment of our July 2002
acquisition of Global Genomics and Global Genomics assets
at the time of its merger with us, which included Global
Genomics
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investments in two genomics companies, Blizzard and Psynomics.
These investments had an aggregate carrying value on our
financial statements, as of September 30, 2003, of
approximately $5.87 million. This accounting review delayed
the completion of our financial statements for the year ended
December 31, 2003 and the filing with the SEC of our Annual
Report on Form 10-K.
Although we had previously disclosed, in our Current Report on
Form 8-K dated January 16, 2004, that we would write
off our investments in Blizzard and Psynomics in the quarter
ended December 31, 2003, the following principal issues
were identified during our accounting review:
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Whether a portion of the purchase price in our July 2002 merger
with Global Genomics (accounted for as a purchase of a group of
assets, not a business combination) should have been allocated
to an acquired assembled workforce, which would have reduced the
amount of the purchase price allocated to the Blizzard and
Psynomics investments ($7.3 million and $78,000,
respectively) and whether the amount originally determined to be
the fair value of the Blizzard investment was overstated. |
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Whether an other-than-temporary impairment charge should have
been taken by us against the appropriate carrying value of the
Blizzard investment earlier than in the fourth quarter of 2003. |
The resolution of these issues in a manner that would result in
a different accounting than originally reported would have had
no effect on our cash or working capital position for any
accounting period nor would it have had a material effect on our
net worth as of December 31, 2003. One possible resolution
could, however, have resulted in our net loss for the year ended
December 31, 2002 being materially larger than that
reported by us in our financial statements for that year and in
our reporting a net worth significantly lower than the net worth
we reported in our financial statements for that year. Such a
resolution, in turn, could have required a restatement of those
financial statements as well as our unaudited financial
statements for the quarterly periods ended March 31, 2003,
June 30, 2003 and September 30, 2003. Other possible
resolutions could have resulted in the recognition of an
other-than-temporary impairment charge in an earlier 2003
quarter and could have required a restatement of our unaudited
financial statements for that and any subsequent quarter.
However, the impact of the resolution of these issues on our net
loss for the year ended December 31, 2002 and/or subsequent
periods were not readily estimable by us, because it would have
depended on the amount of the purchase price to be allocated to
other assets and the nature of those assets and the valuation of
our investment in Blizzard as of December 31, 2002 and as
of the end of each of the three subsequent quarters, each of
which would be dependent upon various assumptions and valuation
methods.
As a result of the issues that were brought to our attention by
PwC, we thoroughly re-reviewed, in late March and early April
2004, the prior accounting treatment for the Global Genomics
acquisition and the Blizzard investment. This review included,
among other things, (i) our submission of additional
documentation to PwC, (ii) discussions of these issues by
our Audit Committee with PwC, (iii) discussions between PwC
and us, (iv) discussions between E&Y and us and
(v) the retention of a nationally respected valuation firm
to review certain of the methodologies that were used by us in
connection with the purchase price allocation for Global
Genomics, including amounts, if any, that would be attributable
to an acquired assembled workforce and methodologies utilized in
our other-than-temporary impairment analyses and to assess what
amount of the purchase price for Global Genomics could
appropriately have been attributable to an acquired assembled
work force, if any.
Following our re-review of the accounting treatment for the
purchase price for the Global Genomics merger and the carrying
value of the Blizzard investment, we advised PwC, in early April
2004, that we continued to believe that our prior accounting
treatment was correct in all material respects. We also advised
PwC that our valuation firm had concluded that, even if any
amount were to be allocated to an acquired assembled workforce,
the valuation of such an acquired workforce would be only
$250,000.
During the course of its engagement PwC informed us that it
disagreed with the timing of the fourth quarter 2003
other-than-temporary impairment charge that we had recorded
related to our investment in Blizzard. PwC also informed us that
PwC needed to significantly expand the scope of its audit
procedures with respect to the matters identified in the fourth
paragraph above, including procedures designed to understand the
impact, if any, of certain third party comments regarding
indicators of value, and that it had not completed
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audit procedures regarding the nature and timing of our
impairment of Blizzard and the original purchase price
allocation upon our acquisition of Global Genomics in 2002. PwC
has advised us that, as a result of their dismissal, they were
unable to complete their expanded audit procedures, and as a
consequence, PwC had not formed a view as to whether our
accounting for these matters was in conformity with accounting
principles generally accepted in the United States.
E&Ys report on our financial statements for the years
ended December 31, 2001 and December 31, 2002 did not
contain any adverse opinion or a disclaimer of an opinion or any
qualification as to uncertainty, audit scope or accounting
principles. In connection with E&Ys audits for those
years there were no disagreements or
reportable events as defined in Item 304 of SEC
Regulation S-K, except as described in this paragraph.
However, we were informed by E&Y, in April 2004, that, until
such time as the impact of the third party comments regarding
indicators of value concerning Blizzard, referred to by PwC,
were further evaluated, E&Y was not able to conclude as to
whether the prior accounting treatment was appropriate in all
material respects. E&Y advised us that, depending upon the
outcome of those procedures, the financial statements for the
year ended December 31, 2002, audited by E&Y, or the
unaudited interim financial statements for the quarters ended
March 31, June 30, and September 30, 2003, might
require restatement. However, E&Y has not withdrawn its
opinion on our 2002 audited financial statements.
A special committee consisting of two of our Audit Committee
members subsequently performed an evaluation of the impact of
the third party comments regarding indicators of value
concerning Blizzard. This special committee concluded that we
did not withhold from E&Y any documents that would have
changed the conclusions reached by E&Y relative to the
carrying value of Blizzard and its audit of our financial
statements. After reviewing this evaluation, E&Y advised us
that it had concluded that our audited 2002 financial statements
and our unaudited interim financial statements for the quarters
ended March 31, 2003 and June 30, 2003 did not require
any restatement. Accordingly, no information has come to the
Companys attention that would lead us to believe that an
investor could no longer rely on E&Ys opinion on our
2002 audited financial statements.
In connection with the preparation of our financial statements
for the year ended December 31, 2003, we believed that we
had a reasonable basis for taking the Blizzard impairment charge
in the fourth quarter of 2003; however, after further review of
the issues relating to the timing of this charge, we determined
in May 2004 that this charge should have been taken in the third
quarter of 2003. We filed an amended Form 10-Q for the
period ended September 30, 2003 in May 2004 to reflect the
impairment charges taken during that period.
During our two fiscal years ended December 31, 2002 and
December 31, 2003 and the interim period through the date
of our engagement of BDO to perform the audit of our financial
statements for the year ended December 31, 2003, we did not
consult with BDO regarding (i) the application of
accounting principles to a specified transaction, either
completed or proposed or the type of audit opinion that might be
rendered on our financial statements, and either a written
report was provided to us or oral advice was provided that BDO
concluded was an important factor considered by us in reaching a
decision as to an accounting, auditing or financial reporting
issue or (ii) any matter that was either the subject of a
disagreement (as defined in paragraph 304(a)(1)(iv) of SEC
Regulation S-K and the related instructions to this item)
or a reportable event (as described in
paragraph 304(a)(1)(v) of SEC Regulation S-K), except
as follows:
|
|
|
|
|
On April 2, 2004, our Audit Committee engaged BDO to
perform agreed-upon procedures with respect to our financial
statements for the year ended December 31, 2003. Due to our
Audit Committees concerns that the concurrent involvement
of two auditing firms might create the appearance that we were
shopping for a particular audit opinion, the terms of our
April 2, 2004 engagement of BDO stated that BDO was not to
conduct a compilation, review or audit, but rather was to
conduct only certain agreed upon procedures. We agreed with BDO
that the procedures would be conducted solely in order to assist
BDO in completing a potential future audit of our financial
statements in the event the Audit Committee subsequently engaged
BDO to opine on our financial statements. Since the agreed upon
procedures specified in our engagement agreement were to be
conducted in preparation for a possible future audit, they
included a majority of the procedures that would have been
necessary in order for BDO to opine with respect to our
financial statements. The specific procedures were proposed by
BDO |
43
|
|
|
|
|
and were jointly accepted by BDO and us without modification. We
have been advised by BDO that, as of April 14, 2004, the
date on which we engaged BDO to become our independent auditor,
BDO had completed approximately 64% of the hours that they
eventually worked to complete their audit, but a significant
portion of the manager and partner review had not yet been
completed. |
|
|
|
Subsequent to engaging BDO to perform these agreed-upon
procedures, we consulted with BDO concerning the need to include
separate audited financial statements of Blizzard in our Annual
Report for the year ended December 31, 2003. BDO orally
advised us that separate audited Blizzard financial statements
were required to be included in this Annual Report. This advice
was consistent with the advice previously received by us from
PwC on this issue, no disagreement on this issue existed between
PwC and us, and we subsequently filed these financial statements
in our Annual Report for the year ended December 31, 2003,
together with our financial statements. |
|
|
|
During the course of BDOs performance of the above
agreed-upon procedures, we did not solicit or receive any oral
or written opinion from BDO with respect to the proper
accounting treatment for the allocation of the purchase price
paid by us in connection with our merger with Global Genomics or
the subsequent carrying value of our investment in Blizzard.
However, we did discuss with BDO our views on the proper
accounting treatment for these items and provided BDO with
certain of our accounting records, a valuation analysis prepared
by a valuation firm in 2002 utilized by management in connection
with its allocation of the purchase price for the Global
Genomics merger and an analysis prepared in April 2004 by
another valuation firm covering certain aspects of the
allocation of that purchase price and the subsequent carrying
value of Blizzard. |
|
|
Item 9A. |
Controls and Procedures |
An evaluation was performed by our management team, with the
participation of our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our
disclosure controls and procedures as of the end of the period
covered by this report. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer have concluded
that our disclosure controls and procedures were effective as of
December 31, 2004 to provide reasonable assurance that
information required to be disclosed by us in reports that we
file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the
Securities and Exchange Commission rules and forms.
There were no changes in our internal control over financial
reporting that occurred during the year ended December 31,
2004, that materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
44
PART III
|
|
Item 10. |
Directors and Executive Officers of the Registrant |
The following table provides information concerning our
directors and executive officers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of | |
|
|
Name |
|
Age | |
|
Directors(1) | |
|
Position |
|
|
| |
|
| |
|
|
Max Link
|
|
|
64 |
|
|
|
III |
|
|
Director, Chairman of the Board(2)(3) |
Steven A. Kriegsman
|
|
|
63 |
|
|
|
II |
|
|
Director, Chief Executive Officer, President |
Marvin R. Selter
|
|
|
77 |
|
|
|
II |
|
|
Director, Vice Chairman of the Board(2)(3)(4) |
Louis Ignarro, Ph.D.
|
|
|
63 |
|
|
|
I |
|
|
Director |
Joseph Rubinfeld, Ph.D.
|
|
|
72 |
|
|
|
I |
|
|
Director(2)(4) |
Richard L. Wennekamp
|
|
|
62 |
|
|
|
II |
|
|
Director(2)(3)(4) |
Mark A. Tepper, Ph.D.
|
|
|
47 |
|
|
|
|
|
|
Vice President; President, CytRx Laboratories, Inc. |
Matthew Natalizio
|
|
|
50 |
|
|
|
|
|
|
Chief Financial Officer, Treasurer |
Jack R. Barber, Ph.D.
|
|
|
49 |
|
|
|
|
|
|
Senior Vice President Drug Development |
Benjamin S. Levin
|
|
|
29 |
|
|
|
|
|
|
General Counsel, Vice President Legal Affairs and
Corporate Secretary |
|
|
(1) |
Class I directors serve until the 2007 annual meeting of
stockholders, Class II directors serve until the 2005
annual meeting of stockholders and Class III directors
serve until the 2006 annual meeting of stockholders. |
|
(2) |
These directors constitute the members of our Audit Committee.
Mr. Selter is the Chairman of the Committee. |
|
(3) |
These directors constitute the members of our Nominating and
Corporate Governance Committee. Mr. Wennekamp is Chairman
of the Committee. |
|
(4) |
These directors constitute the members of our Compensation
Committee. Dr. Rubinfeld is Chairman of the committee. |
Max Link has been a director since 1996. From March 2001
to October 2003, Dr. Link was Chairman and Chief Executive
Officer of Centerpulse, Ltd. From May 1993 to June 1994,
Dr. Link served as the Chief Executive Officer of Corange
U.S. Holdings, Inc. (the holding company for Boehringer
Mannheim Therapeutics, Boehringer Mannheim Diagnostics and DePuy
International). From 1992 to 1993, Dr. Link was Chairman of
Sandoz Pharma, Ltd. From 1987 to 1992, Dr. Link was the
Chief Executive Officer of Sandoz Pharma and a member of the
Executive Board of Sandoz, Ltd., Basel. Prior to 1987,
Dr. Link served in various capacities with the United
States operations of Sandoz, including President and Chief
Executive Officer. Dr. Link also serves as a director of
Access Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc.,
Cell Therapeutics, Inc., Celsion Corporation, Discovery
Laboratories, Inc., Human Genome Sciences, Inc. and Protein
Design Laboratories, Inc.
Steven A. Kriegsman has been a director and our President
and Chief Executive Officer since July 2002. He previously
served as a director and the Chairman of Global Genomics since
June 2000. Mr. Kriegsman is Chairman and founder of
Kriegsman Capital Group LLC, a financial advisory firm
specializing in the development of alternative sources of equity
capital for emerging growth companies. Mr. Kriegsman has
advised such companies as Closure Medical Corporation, Novoste
Corporation, Miravant Medical Technologies, Maxim
Pharmaceuticals and Supergen Inc. Mr. Kriegsman has a B.S.
degree from New York University in accounting and completed the
Executive Program in Mergers and Acquisitions at New York
University, The Management Institute. Mr. Kriegsman serves
as a director of Bradley Pharmaceuticals, Inc.
45
Marvin R. Selter has been a director since October 2003.
He has been the President of CMS, Inc. since he founded that
firm in 1968. CMS, Inc. is a national management consulting
firm. Mr. Selter serves on the Executive Committee of the
SFV Economic Alliance, is Chairman of the Valley Economic
Development Center, is a member of the Business Tax Advisory
Committee-City of Los Angeles, and is a member of the Small
Business Board and Small Business Advisory Commission-State of
California. He has served, and continues to serve, as a member
of boards of directors of various hospitals, universities,
private medical companies and other organizations.
Mr. Selter attended Rutgers University and majored in
Accounting and Business Administration.
Louis Ignarro, Ph.D. has been a director since July
2002. He previously served as a director of Global Genomics
since November 20, 2000. Dr. Ignarro serves as the
Jerome J. Bezler, M.D. Distinguished Professor of
Pharmacology in the Department of Molecular and Medical
Pharmacology at the UCLA School of Medicine. Dr. Ignarro
has been at the UCLA School of Medicine since 1985 as a
professor, acting chairman and assistant dean. Dr. Ignarro
received the Nobel Prize for Medicine in 1998. Dr. Ignarro
received a B.S. in pharmacy from Columbia University and his
Ph.D. in Pharmacology from the University of Minnesota.
Joseph Rubinfeld, Ph.D. has been a director since
July 2002. He co-founded SuperGen, Inc. in 1991 and has served
as its Chief Executive Officer and President and as a director
since its inception until December 31, 2003. He resigned as
Chairman Emeritus of SuperGen, Inc. on Februrary 8, 2005.
Dr. Rubinfeld was also Chief Scientific Officer of SuperGen
from 1991 until September 1997. Dr. Rubinfeld is also a
founder of, and currently serves as the Chairman and Chief
Executive Officer of, JJ Pharma. Dr. Rubinfeld was one of
the four initial founders of Amgen, Inc. in 1980 and served as a
Vice President and its Chief of Operations until 1983. From 1987
until 1990, Dr. Rubinfeld was a Senior Director at Cetus
Corporation and from 1968 to 1980, Dr. Rubinfeld was
employed at Bristol-Myers Company, International Division in a
variety of positions. Dr. Rubinfeld received a B.S. degree
in chemistry from C.C.N.Y. and an M.A. and Ph.D. in chemistry
from Columbia University.
Richard L. Wennekamp has been a director since October
2003. He has been the Senior Vice President-Credit
Administration of Community Bank since October 2002. From
September 1998 to July 2002, Mr. Wennekamp was an executive
officer of Bank of America Corporation, holding various
positions, including Managing Director-Credit Product Executive
for the last four years of his 22-year term with the bank. From
1977 through 1980, Mr. Wennekamp was a Special Assistant to
former President of the United States, Gerald R. Ford, and the
Executive Director of the Ford Transition Office. Prior thereto,
he served as Staff Assistant to the President of the United
States for one year, and as the Special Assistant to the
Assistant Secretary of Commerce of the U.S.
Mark A. Tepper, Ph.D. has been the President and
co-founder of our subsidiary CytRx Laboratories (formerly
Araios, Inc.) and our Corporate Vice President since September
2003. From November 2002 to August 2003, he served as an
independent pharmaceutical consultant. Prior to that, from April
2002 to October 2002, he served as President and CEO of
Arradial, Inc., an Oxford Biosciences Venture-backed company
developing a novel microfluidics based drug discovery platform.
From April 1995 to March 2002, Dr. Tepper served in a
number of senior management roles at Serono including Vice
President, Research and Operations for the US Pharmaceutical
Research Institute and Executive Director of Lead Discovery.
From 1988 to 1995, Dr. Tepper was Sr. Research Investigator
at the Bristol Myers Squibb Pharmaceutical Research Institute
where he worked on the discovery and development of novel drugs
in the area of Oncology and Immunology. Prior to that,
Dr. Tepper was a post-doctoral fellow at the University of
Massachusetts Medical School in the laboratory of
Dr. Michael Czech. Dr. Tepper received a B.A. in
Chemistry from Clark University with highest honors, and a Ph.D.
in Biochemistry and Biophysics from Columbia University.
Matthew Natalizio has been our Chief Financial Officer
and Treasurer since July 2004. From November 2002 to December
2003, he was President and General Manager of a privately held
furniture manufacturing company. Prior to that, from January
2000 to October 2002, he was Chief Financial Officer at Qualstar
Corporation, a publicly traded designer and manufacturer of data
storage devices. He was also the Vice President of Operations
Support, the Vice President Finance and Treasurer of
Superior National Insurance Group, a publicly traded
workers compensation insurance company. Mr. Natalizio
is a CPA who worked at
46
Ernst and Young as an Audit Manager and Computer Audit Executive
and was a Senior Manager at KPMG. He earned his Bachelor of Arts
degree in Economics from the University of California, Los
Angeles.
Jack Barber, Ph.D. has been our Senior Vice
President Drug Development since July 2004. He
previously served as Chief Technical Officer and Vice President
of Research and Development at Immusol, a biopharmaceutical
company based in San Diego, California, since 1994. Prior
to that, Dr. Barber spent seven years in various management
positions at Viagene, most recently serving as Associate
Director of Oncology. Dr. Barber received both his B.S. and
Ph.D. in Biochemistry from the University of California, Los
Angeles. He also carried out his post-doctoral fellowship at the
Salk Institute for Biological Studies in La Jolla,
California.
Benjamin S. Levin has been our General Counsel, Vice
President Legal Affairs and Corporate Secretary
since July 2004. From November 1999 to June 2004, Mr. Levin
was an associate in the transactions department of the Los
Angeles office of OMelveny & Myers LLP.
Mr. Levin received his S.B. in Economics from the
Massachusetts Institute of Technology, and a J.D. from Stanford
Law School.
Our board of directors has determined that Messrs. Link,
Rubinfeld, Selter and Wennekamp are independent
under the current independence standards of both the Nasdaq
Stock Market and the SEC, and have no material relationships
with us (either directly or as a partner, shareholder or officer
of any entity) which could be inconsistent with a finding of
their independence as members of our board of directors or as
the members of our Audit Committee. In making these
determinations, our board of directors has broadly considered
all relevant facts and circumstances, recognizing that material
relationships can include commercial, banking, consulting,
legal, accounting, and familial relationships, among others.
Our board of directors has determined that Mr. Selter, one
of the independent directors serving on our Audit Committee,
also is an audit committee financial expert as defined by the
SECs rules.
Section 16(a) Beneficial Ownership Reporting
Compliance
Our executive officers and directors and any person who owns
more than 10% of our outstanding shares of common stock are
required by Section 16(a) of the Securities Exchange Act to
file with the SEC initial reports of ownership and reports of
changes in ownership of our common stock and to furnish us with
copies of those reports. Based solely on our review of copies of
reports we have received and written representations from
certain reporting persons, we believe that all
Section 16(a) filing requirements applicable to our
directors and executive officers and greater than 10%
shareholders for 2003 were complied with, except that reports
for the following transactions were filed late due to
administrative oversights:
|
|
|
|
|
Grants of stock options to Messrs. Ignarro, Rubinfeld,
Link, Selter and Wennekamp, directors of the Company, in July
2004; and |
|
|
|
The acquisition by Mr. Wennekamp of shares of our common
stock in August 2004. |
Forms 4 reporting each of the above transactions were
subsequently filed by these individuals.
Code of Ethics
We have adopted a Code of Ethics applicable to our principal
executive officer, principal financial officer, and principal
accounting officer or controller, a copy of which is filed as an
exhibit to this Form 10-K.
|
|
Item 11. |
Executive Compensation |
Summary Compensation Table
The following table presents summary information concerning all
compensation paid or accrued by us for services rendered in all
capacities during the fiscal years ended December 31, 2004,
2003 and 2002 by Steven
47
A. Kriegsman, our President and Chief Executive Officer, and
four other most highly compensated executive officers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Term | |
|
|
|
|
|
|
|
|
|
|
Compensation | |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
Securities | |
|
|
|
|
|
|
|
|
|
|
Underlying | |
|
All Other | |
Name and Principal Position |
|
Year | |
|
Salary | |
|
Bonus | |
|
Options (#) | |
|
Compensation | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Steven A. Kriegsman
|
|
|
2004 |
|
|
$ |
361,173 |
|
|
$ |
150,000 |
|
|
|
|
|
|
$ |
42,617 |
(1) |
|
President and Chief Executive Officer
|
|
|
2003 |
|
|
$ |
313,772 |
|
|
$ |
150,000 |
|
|
|
1,000,000 |
(2) |
|
|
|
|
|
|
|
|
2002 |
(3) |
|
$ |
110,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Jack R. Barber, Ph.D.
|
|
|
2004 |
(4) |
|
$ |
112,910 |
|
|
$ |
|
|
|
|
100,000 |
|
|
|
|
|
|
Vice President Drug Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark A. Tepper, Ph.D.
|
|
|
2004 |
|
|
$ |
200,699 |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
Senior Vice President and |
|
|
2003 |
(6) |
|
$ |
58,333 |
|
|
$ |
|
|
|
|
400,000 |
(5) |
|
|
|
|
|
President, CytRx Laboratories, Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matthew Natalizio
|
|
|
2004 |
(7) |
|
$ |
82,900 |
|
|
$ |
|
|
|
|
100,000 |
(5) |
|
|
|
|
|
Chief Financial Officer and Treasurer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benjamin S. Levin
|
|
|
2004 |
(8) |
|
$ |
80,881 |
|
|
$ |
|
|
|
|
160,000 |
(5) |
|
|
|
|
|
General Counsel, Vice President Legal Affairs and
Corporate Secretary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
The amount shown includes approximately $5,000 in insurance
premiums paid by us with respect to a life insurance policy for
Mr. Kriegsman which has a face value of approximately
$1.4 million as of December 31, 2004 and under which
Mr. Kriegsmans designee is the beneficiary. The
amount shown also includes approximately $37,617 of legal fees
and expenses paid or reimbursed by us in accordance with the
terms of Mr. Kriegsmans employment agreement
described below under Employment Agreement with Steven A.
Kriegsman. |
|
(2) |
250,000 of the options shown vested on each of June 20,
2003 and June 20, 2004. The remaining 500,000 of the
options shown vest in twenty-four monthly installments of
1/24th each on the 20th day of each month beginning on
June 20, 2004, subject to Mr. Kriegsmans
remaining in our continuous employ through such dates. |
|
(3) |
Mr. Kriegsman has been our President and Chief Executive
Officer since July 2002. |
|
(4) |
Dr. Barber was hired on July 6, 2004. |
|
(5) |
The options shown are subject to vesting in three annual
installments of 1/3rd each on each of the first three
anniversaries of the named executive officers date of
hire, subject to his remaining in our continuous employ through
such dates. |
|
(6) |
Dr. Tepper was hired on September 20, 2003. |
|
(7) |
Mr. Natalizio was hired on July 12, 2004. |
|
(8) |
Mr. Levin was hired on July 15, 2004. |
48
Option Grants in Last Fiscal Year
The following table contains information concerning grants of
stock options during the fiscal year ended December 31,
2004 to the executive officers named in the Summary Compensation
Table:
Option Grants in Twelve Months Ended December 31,
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual Grants | |
|
|
|
Potential Realized Value | |
|
|
| |
|
|
|
at Assumed Annual Rates | |
|
|
Number of | |
|
% of Total | |
|
|
|
of Stock Price | |
|
|
Shares | |
|
Options | |
|
|
|
Appreciation for Option | |
|
|
Underlying | |
|
Granted to | |
|
|
|
Term(1) | |
|
|
Options | |
|
Employees In | |
|
Exercise | |
|
| |
Name |
|
Granted | |
|
Fiscal Year | |
|
Price | |
|
5% | |
|
10% | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Steven A. Kriegsman
|
|
|
|
|
|
|
|
% |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Jack R. Barber, Ph.D.
|
|
|
100,000 |
|
|
|
16.2 |
% |
|
$ |
1.13 |
|
|
$ |
71,065 |
|
|
$ |
180,093 |
|
Mark A. Tepper, Ph.D.
|
|
|
|
|
|
|
|
% |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Matthew Natalizio
|
|
|
100,000 |
|
|
|
16.2 |
% |
|
$ |
1.11 |
|
|
$ |
69,807 |
|
|
$ |
176,905 |
|
Benjamin S. Levin
|
|
|
160,000 |
|
|
|
25.9 |
% |
|
$ |
1.39 |
|
|
$ |
139,866 |
|
|
$ |
354,448 |
|
|
|
(1) |
The potential realizable value shown in this table represents
the hypothetical gain that might be realized based on assumed 5%
and 10% annual compound rates of stock price appreciation over
the full option term. These prescribed rates are not intended to
forecast possible future appreciation of the common stock. |
Fiscal Year-End Option Values
The following table sets forth the number of options and total
value of unexercised in-the-money options and warrants at
December 31, 2004 for the executive officers named in the
Summary Compensation Table, using the price per share of our
common stock of $1.40 on December 31, 2004. No stock
options were exercised during 2004 by the executive officers
named.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
Underlying Unexercised | |
|
Value of Unexercised | |
|
|
Options at | |
|
In-the-Money Options at | |
|
|
December 31, 2004 (#) | |
|
December 31, 2004 ($) | |
|
|
| |
|
| |
Name |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
Steven A. Kriegsman(1)
|
|
|
971,852 |
|
|
|
487,500 |
|
|
$ |
638,499 |
|
|
$ |
|
|
Jack R. Barber, Ph.D.
|
|
|
|
|
|
|
100,000 |
|
|
$ |
|
|
|
$ |
27,000 |
|
Mark A. Tepper, Ph.D.
|
|
|
133,333 |
|
|
|
266,667 |
|
|
$ |
|
|
|
$ |
|
|
Matthew Natalizio
|
|
|
|
|
|
|
100,000 |
|
|
$ |
|
|
|
$ |
29,000 |
|
Benjamin S. Levin
|
|
|
|
|
|
|
160,000 |
|
|
$ |
|
|
|
$ |
1,600 |
|
|
|
(1) |
Includes warrants issued to Mr. Kriegsman by Global
Genomics prior to our merger with that company covering
459,352 shares of our common stock. |
Compensation of Directors
Periodically, our board of directors reviews our director
compensation policies and, from time to time, makes changes to
such policies based on various criteria the board deems
relevant. During 2004, directors who were employees of our
company received no compensation for their service as directors
or as members of board committees.
During 2004, our non-employee directors received a quarterly
retainer of $1,500 and a fee of $1,500 for each board meeting
attended ($750 for meetings attended by teleconference and for
board actions taken by unanimous written consent) and $750 for
each committee meeting attended. Non-employee directors who
chair the board or a board committee receive an additional $250
for each meeting attended as the chair. In May 2004 we made a
payment of $7,500, plus reimbursement of certain expenses, to
each of Messrs. Selter
49
and Wennekamp in connection with their services as members of
our Audit Committee. We grant options to
purchase 15,000 shares of common stock at an exercise
price equal to the current market value of our common stock to
each non-employee director annually, usually in the summer of
each year. Such option grants are made subject to vesting in
annual increments of 1/3rd each, subject to the director
remaining as a director.
Equity Compensation Plans
The following table sets forth certain information as of
December 31, 2004 regarding securities authorized for
issuance under our equity compensation plans. This table
excludes warrants previously issued to Steven A. Kriegsman by
Global Genomics that we assumed in connection with our merger
with that company.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) | |
|
|
(a) | |
|
|
|
Number of Securities | |
|
|
Number of Securities | |
|
(b) | |
|
Remaining Available | |
|
|
to be Issued Upon | |
|
Weighted-Average | |
|
for Issuance Under Equity | |
|
|
Exercise of | |
|
Exercise Price of | |
|
Compensation | |
|
|
Outstanding Options, | |
|
Outstanding Options, | |
|
Plans (Excluding Securities | |
|
|
Warrants and Rights | |
|
Warrants and Rights | |
|
Reflected in Column (a)) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by our stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1994 Stock Option Plan
|
|
|
30,834 |
|
|
$ |
1.00 |
|
|
|
70,850 |
|
|
1995 Stock Option Plan
|
|
|
|
|
|
|
|
|
|
|
22,107 |
|
|
1998 Long-Term Incentive Plan
|
|
|
132,541 |
|
|
|
1.00 |
|
|
|
29,517 |
|
|
2000 Long-Term Incentive Plan
|
|
|
4,577,667 |
|
|
|
1.16 |
|
|
|
5,422,333 |
|
Equity compensation plans not approved by our stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding warrants(1)
|
|
|
5,098,240 |
|
|
|
1.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
|
9,839,282 |
|
|
$ |
1.52 |
|
|
|
5,544,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Issued as compensation for various services and does not include
warrants attached to common stock that were sold in private
placement transactions. |
Perquisites
In general, we afford our directors and executive officers no
perquisites apart from the compensation and stock option
benefits described above and any benefits specifically provided
for under the terms of any employment agreement as described
below. We do, however, bear the cost of outside counsel employed
by us to assist directors and executive officers in preparing
reports of changes in beneficial ownership under Section 16
of the Securities Exchange Act of 1934 and other Section 16
compliance matters. We also permit Mr. Kriegsman, our
President and Chief Executive Officer, and our directors to fly
first-class for business travel, which is an exception to our
usual practice for business travel by our officers and employees.
Employment Agreements; Change in Control Agreements
|
|
|
Employment Agreement with Steven A. Kriegsman |
Mr. Kriegsman is employed as our Chief Executive Officer
pursuant to an employment agreement that was amended and
restated as of June 10, 2003 to continue through
July 15, 2006. The employment agreement will automatically
renew in July 2006 for an additional one-year period, unless
either Mr. Kriegsman or we elect not to renew it.
Under his employment agreement, Mr. Kriegsman is entitled
to an annual base salary of $360,000. Our board of directors (or
its Compensation Committee) will review the base salary annually
and may increase
50
(but not decrease) it in its sole discretion, and on
March 14, 2005, the Compensation Committee determined to
increase Mr. Kriegsmans base salary to $400,000,
effective January 1, 2005. In addition to his annual
salary, Mr. Kriegsman is eligible to receive an annual
bonus as determined by our board of directors (or its
Compensation Committee) in its sole discretion, but not to be
less than $150,000. Pursuant to his employment agreement with
us, we have agreed that he shall serve on a full-time basis as
our Chief Executive Officer and that he may continue to serve as
President of the Kriegsman Group only so long as necessary to
complete certain current assignments.
Mr. Kriegsman is eligible to receive grants of options to
purchase shares of our common stock. The number and terms of
those options, including the vesting schedule, will be
determined by our board of directors (or its Compensation
Committee) in its sole discretion.
Under Mr. Kriegsmans employment agreement, we have
agreed that, if he is made a party, or threatened to be made a
party, to a suit or proceeding by reason of his service to us,
we will indemnify and hold him harmless from all costs and
expenses to the fullest extent permitted or authorized by our
certificate of incorporation or bylaws, or any resolution of our
board of directors, to the extent not inconsistent with Delaware
law. We also have agreed to advance to Mr. Kriegsman such
costs and expenses upon his request if he undertakes to repay
such advances if it ultimately is determined that he is not
entitled to indemnification with respect to the same. These
employment agreement provisions are not exclusive of any other
rights to indemnification to which Mr. Kriegsman may be
entitled and are in addition to any rights he may have under any
policy of insurance maintained by us.
In the event we terminate Mr. Kriegsmans employment
without cause (as defined), or if Mr. Kriegsman
terminates his employment with good reason (as
defined), (i) we have agreed to pay Mr. Kriegsman a
lump-sum equal to his salary and prorated minimum annual bonus
through to his date of termination, plus his salary and minimum
annual bonus for a period of two years after his termination
date, or until the expiration of the amended and restated
employment agreement, whichever is later, (ii) he will be
entitled to immediate vesting of all stock options or other
awards based on our equity securities, and (iii) he will
also be entitled to continuation of his life insurance premium
payments and continued participation in any of our health plans
through to the later of the expiration of the amended and
restated employment agreement or 24 months following his
termination date. Mr. Kriegsman will have no obligation in
such events to seek new employment or offset the severance
payments to him by the Company by any compensation received from
any subsequent reemployment by another employer.
Under Mr. Kriegsmans employment agreement, he and his
affiliated company, The Kriegsman Group, are to provide us
during the term of his employment with the first opportunity to
conduct or take action with respect to any acquisition
opportunity or any other potential transaction identified by
them within the biotech, pharmaceutical or health care
industries and that is within the scope of the business plan
adopted by our board of directors. Mr. Kriegsmans
employment agreement also contains confidentiality provisions
relating to our trade secrets and any other proprietary or
confidential information, which provisions shall remain in
effect for five years after the expiration of the employment
agreement with respect to proprietary or confidential
information and for so long as our trade secrets remain trade
secrets.
|
|
|
Change in Control Agreement with Steven A.
Kriegsman |
Mr. Kriegsmans employment agreement contains no
provision for payment to him in the event of a change in control
of CytRx. If, however, a change in control (as defined in our
2000 Long-Term Incentive Plan) occurs during the term of the
employment agreement, and if, during the term and within two
years after the date on which the change in control occurs,
Mr. Kriegsmans employment is terminated by us without
cause or by him for good reason (each as defined in his
employment agreement), then, to the extent that any payment or
distribution of any type by us to or for the benefit of
Mr. Kriegsman resulting from the termination of his
employment is or will be subject to the excise tax imposed under
Section 4999 of the Internal Revenue Code of 1986, as
amended, we have agreed to pay Mr. Kriegsman, prior to the
time the excise tax is payable with respect to any such payment
(through withholding or otherwise), an additional amount that,
after the imposition of all income, employment, excise and other
taxes, penalties and interest thereon, is equal to the
51
sum of (i) the excise tax on such payments plus
(ii) any penalty and interest assessments associated with
such excise tax.
|
|
|
Employment Agreement with Matthew Natalizio |
Matthew Natalizio became our Chief Financial Officer on
July 12, 2004 pursuant to a one-year employment agreement
with us. Mr. Natalizio is entitled under his employment
agreement to an annual base salary of $175,000 and is eligible
to receive an annual bonus as determined by our board of
directors (or its Compensation Committee) in its sole
discretion. As an incentive to enter the employment agreement,
Mr. Natalizio was granted as of July 12, 2004 a
ten-year, nonqualified option under our 2000 Long-Term Incentive
Plan to purchase 100,000 shares of our common stock at
a price of $1.11 per share. This option will vest as to
1/3rd of the shares covered thereby on each of the first
three anniversaries of the employment agreement, provided that
Mr. Natalizio remains in our continuous employ.
In the event we terminate Mr. Natalizios employment
without cause (as defined), we have agreed to pay him a lump-sum
equal to his accrued but unpaid salary and vacation, plus an
amount equal to 1/360th of his salary for each four days
(prorated for any period of less than four days) that he was
employed prior to the date of his termination.
|
|
|
Employment Agreement with Jack R.
Barber, Ph.D. |
Jack R. Barber, Ph.D., became our Senior Vice
President Drug Development on July 6, 2004
pursuant to a one-year employment agreement with us. Under his
employment agreement, Dr. Barber is entitled to an annual
base salary of $230,000 and is eligible to receive an annual
bonus as determined by our board of directors (or its
Compensation Committee) in its sole discretion. As an incentive
to enter the employment agreement, Dr. Barber was granted
as of July 6, 2004 a ten-year, nonqualified option under
our 2000 Long-Term Incentive Plan to
purchase 100,000 shares of our common stock at a price
of $1.13 per share. This option will vest as to
1/3rd of the shares covered thereby on each of the first
three anniversaries of the employment agreement, provided that
Dr. Barber remains in our continuous employ.
In the event we terminate Dr. Barbers employment
without cause (as defined), we have agreed to pay him a lump-sum
equal to his accrued but unpaid salary and vacation, plus an
amount equal to 1/360th of his salary for each four days
(prorated for any period of less than four days) that he was
employed prior to the date of his termination.
|
|
|
Employment Agreement with Mark A.
Tepper, Ph.D. |
Mark A. Tepper, Ph.D., became President of our CytRx
Laboratories, Inc. subsidiary on September 17, 2003
pursuant to a two-year employment agreement with CytRx
Laboratories, Inc. Under his employment agreement,
Dr. Tepper is entitled to an annual base salary of $200,000
and is eligible to receive an annual bonus targeted at $50,000
based upon achievement of certain milestones as agreed upon by
Dr. Tepper and the board of directors of CytRx
Laboratories, Inc. As an incentive to enter into the employment
agreement, Dr. Tepper was granted ten-year, nonqualified
options under our 2000 Long-Term Incentive Plan to
purchase 120,000 shares of our common stock at a price
of $2.41 per share and a separate ten-year nonqualified
option under the Plan to purchase 280,000 shares at an
exercise price of $2.35 per share. These options will vest
as to 1/3rd of the shares covered thereby on each of the
first three anniversaries of the employment agreement, provided
that Dr. Tepper remains in our continuous employ.
In the event Dr. Teppers employment is terminated
without cause (as defined), we have agreed to continue to pay
Dr. Tepper his salary and other employee benefits for a
period of six months following his termination and to
immediately vest in Dr. Tepper all of his stock options
referred to above.
|
|
|
Employment Agreement with Benjamin S. Levin |
Benjamin S. Levin became our Vice President Legal
Affairs, General Counsel and Secretary on July 15, 2004
pursuant to a one-year employment agreement with us.
Mr. Levin is entitled under his
52
employment agreement to an annual base salary of $175,000 and is
eligible to receive an annual bonus as determined by our board
of directors (or its Compensation Committee) in its sole
discretion. As an incentive to enter into the employment
agreement, Mr. Levin was granted as of July 15, 2004 a
ten-year, nonqualified option under our 2000 Long-Term Incentive
Plan to purchase 160,000 shares of our common stock at
a price of $1.39 per share. This option will vest as to
1/3rd of the shares covered thereby on each of the first
three anniversaries of the employment agreement, provided that
Mr. Levin remains in our continuous employ.
In the event we terminate Mr. Levins employment
without cause (as defined), we have agreed to pay
Mr. Levin a lump-sum equal to his accrued but unpaid salary
and vacation, plus an amount equal to an additional three
months salary under his employment agreement (or six
months salary if the employment agreement has been renewed
as provided above).
Compensation Committee Interlocks and Insider Participation
in Compensation Decisions
There are no interlocks, as defined by the SEC, with
respect to any member of the compensation committee. Joseph
Rubinfeld, Ph.D., Marvin R. Selter and Richard L. Wennekamp
are the current members of the compensation committee.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
Based solely upon information made available to us, the
following table sets forth information with respect to the
beneficial ownership of our common stock as of January 31,
2005 by (1) each person who is known by us to beneficially
own more than five percent of the common stock; (2) each
director; (3) the named executive officers listed in the
Summary Compensation Table under Item 11; and (4) all
executive officers and directors as a group.
Beneficial ownership is determined in accordance with the SEC
rules. Shares of common stock subject to any warrants or options
that are presently exercisable, or exercisable within
60 days of January 31, 2005, which are indicated by
footnote, are deemed outstanding for the purpose of computing
the percentage ownership of the person holding the warrants or
options, but are not treated as outstanding for the purpose of
computing the percentage ownership of any other person. The
percentage ownership reflected in the table is based on
57,048,449 shares of our common stock outstanding as of
January 31, 2005. Except as otherwise indicated, the
holders listed below have sole voting and investment power with
respect to all shares of common stock shown, subject to
applicable community property laws. An asterisk represents
beneficial ownership of less than 1%.
|
|
|
|
|
|
|
|
|
|
|
Shares of | |
|
|
Common Stock | |
|
|
| |
Name of Beneficial Owner |
|
Number | |
|
Percent | |
|
|
| |
|
| |
Louis Ignarro, Ph.D.(1)
|
|
|
405,982 |
|
|
|
* |
|
Steven A. Kriegsman(2)
|
|
|
4,539,850 |
|
|
|
7.8 |
% |
Max Link(3)
|
|
|
48,749 |
|
|
|
* |
|
Joseph Rubinfeld(4)
|
|
|
11,999 |
|
|
|
* |
|
Marvin R. Selter(5)
|
|
|
360,784 |
|
|
|
* |
|
Richard Wennekamp(6)
|
|
|
8,333 |
|
|
|
* |
|
Mark A. Tepper(7)
|
|
|
133,333 |
|
|
|
* |
|
All executive officers and directors as a group (ten persons)(8)
|
|
|
5,509,030 |
|
|
|
9.4 |
% |
|
|
(1) |
Includes 314,066 shares subject to options or warrants. |
|
(2) |
Includes 978,102 shares subject to options or warrants.
Mr. Kriegsmans address is c/o CytRx Corporation,
11726 San Vicente Boulevard, Suite 650, Los Angeles,
CA 90049. |
|
(3) |
Includes 19,542 shares subject to options or warrants. |
|
(4) |
Includes 11,999 shares subject to options or warrants. |
53
|
|
(5) |
The shares shown are owned, of record, by the Selter Family
Trust or Selter IRA Rollover. Includes 3,333 shares subject
to options or warrants owned by Mr. Selter. |
|
(6) |
Includes 3,333 shares subject to options or warrants. |
|
(7) |
Includes 133,333 shares subject to options or warrants. |
|
(8) |
Includes 1,463,708 shares subject to options or warrants. |
|
|
Item 13. |
Certain Relationships and Related Transactions |
Since July 16, 2002, Steven A. Kriegsman has been our Chief
Executive Officer and one of our directors. In July 2002, we
entered into an agreement with the Kriegsman Capital Group, or
KCG, an affiliate of Mr. Kriegsman, whereby KCG agreed to
provide us with office space and certain administrative
services. In 2003, we paid a total of approximately $70,000 to
KCG under this agreement. The charges were determined based upon
actual space used and estimated percentages of employee time
used. In October 2003, the services and facilities agreement
with KCG was terminated as substantially all of the on-going
operations of KCG have ceased. The obligations under the
facility lease at our headquarters were transferred from KCG to
us in July 2003. We believe that the terms under which we paid
KCG for rent and other expenses are at least as favorable to us
as could have been obtained from an unrelated third party.
We entered into an agreement, dated as of July 17, 2003
(and subsequently amended on October 18, 2003), with Louis
Ignarro, Ph.D., one of our current directors. Pursuant to
the agreement, Dr. Ignarro agreed to serve as our Chief
Scientific Spokesperson to the medical and financial
communities. As payment for his services, Dr. Ignarro was
granted a non-qualified stock option under our 2000 Long-Term
Incentive Plan to purchase 350,000 registered shares of our
common stock at an exercise price equal to $1.89, the closing
price for our common stock on Nasdaq on the date of grant. The
option has a term of seven years, and from July 17, 2003 to
October 17, 2003, vested monthly at the rate of
4,839 shares for each day of services provided by
Dr. Ignarro in that month and, from October 18, 2003,
vests monthly at a rate of 15,975 shares for the remaining
term of the agreement. Either party may terminate the agreement
at any time, and any unvested shares under the option as of the
date of termination of the agreement will be cancelled. As of
January 31, 2005, 270,117 shares of common stock under
the option had vested.
|
|
Item 14. |
Principal Accountant Fees and Services |
BDO Seidman, LLP, or BDO, serves as our independent accountants
and audited our financial statements for the years ended
December 31, 2003 and 2004. Ernst & Young LLP, or
E&Y, previously served as our independent accountants and
audited our financial statements for the year ended
December 31, 2002.
Audit Fees
The aggregate fees billed for professional services rendered for
the audit of the Companys annual financial statements for
the fiscal year ended December 31, 2003 and the estimated
fees for the audit for the fiscal year ended December 31,
2004 are as follows:
|
|
|
|
|
Year: |
|
BDO | |
|
|
| |
2004
|
|
$ |
217,000 |
|
2003
|
|
$ |
160,000 |
|
E&Y reviewed our financial statements included in our
Form 10-Qs during the year ended December 31, 2003.
The aggregate fees billed for professional services rendered by
E&Y for the review of such financial statements were
approximately $23,000.
Audit Related Fees
For the fiscal year ended December 31, 2003, BDO rendered
$45,000 of other audit-related services, which consisted of
certain agreed-upon procedures performed prior to their audit of
our financial statements
54
for fiscal 2003. No assurance or other audit-related services
were rendered by BDO for the fiscal year ended December 31,
2004 or by E&Y for the fiscal year ended December 31,
2003.
Tax Fees
The aggregate fees billed by BDO for professional services for
tax compliance, tax advice and tax planning for the year ended
December 31, 2003 and the estimated fees for such services
being provided by BDO for the year ended December 31, 2004
were $25,000 and $20,000, respectively.
All Other Fees
No other services were rendered by E&Y or BDO for the years
ended December 31, 2003 or December 31, 2004. Our
Audit Committee has pre-approved all services (audit and
non-audit) provided or to be provided to us by E&Y or BDO
for the years ended December 31, 2003 and December 31,
2004.
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules |
(a) Documents filed as part of this 10-K:
The consolidated financial statements of the Company and the
related report of independent registered public accounting firms
thereon are set forth on pages F-1 to F-23 of this Annual
Report on Form 10-K. These consolidated financial
statements are as follows:
Consolidated Balance Sheets as of December 31, 2004 and 2003
Consolidated Statements of Operations for the Years Ended
December 31, 2004, 2003 and 2002
|
|
|
Consolidated Statements of Stockholders Equity for the
Years Ended December 31, 2004, 2003 and 2002 |
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2004, 2003 and 2002
Notes to Consolidated Financial Statements
Reports of Independent Registered Public Accounting Firms
(2) Financial Statement Schedules
The following financial statement schedule is set forth on
page F-24 of this Annual Report on Form 10-K.
Schedule II Valuation and Qualifying Accounts
for the years ended December 31, 2004, 2003 and 2002
All other schedules are omitted because they are not required,
not applicable, or the information is provided in the financial
statements or notes thereto.
(b) Exhibits
See Exhibit Index on page 56 of this Annual Report on
Form 10-K.
55
CytRx Corporation
Form 10-K Exhibit Index
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
|
|
Footnote |
|
|
|
|
|
|
2 |
.1 |
|
Agreement and Plan of Merger dated February 11, 2002 among
CytRx Corporation, GGC Merger Corporation and GlobalGenomics
Capital, Inc. |
|
|
(m) |
|
|
2 |
.2 |
|
First Amendment to Agreement and Plan of Merger dated
May 22, 2002 among CytRx Corporation, GGC Merger
Corporation and Global Genomics Capital, Inc. |
|
|
(m) |
|
|
3 |
.1 |
|
Restated Certificate of Incorporation |
|
|
(a) |
|
|
3 |
.2 |
|
Restated By-Laws |
|
|
(b) |
|
|
3 |
.3 |
|
Certificate Of Amendment To Restated Certificate of Incorporation |
|
|
(m) |
|
|
3 |
.4 |
|
Corrected Restated Certificate of Incorporation |
|
|
(n) |
|
|
3 |
.5 |
|
Certificate of Amendment to Restated Certificate of Incorporation |
|
|
(n) |
|
|
4 |
.1 |
|
Shareholder Protection Rights Agreement dated April 16,
1997 between CytRx Corporation and American Stock
Transfer &Trust Company as Rights Agent |
|
|
(c) |
|
|
4 |
.2 |
|
Amendment No. 1 to Shareholder Protection Rights Agreement |
|
|
(k) |
|
|
4 |
.3 |
|
Stock Restriction and Registration Rights Agreement |
|
|
(o) |
|
|
4 |
.4 |
|
Warrant issued on July 20, 2002 to Corporate Consulting
International Group pursuant to Consulting Engagement Letter
dated July 20, 2002 |
|
|
(p) |
|
|
4 |
.5 |
|
Warrant issued on February 21, 2003 to Corporate Capital
Group International Ltd. Inc. |
|
|
(r) |
|
|
4 |
.6 |
|
Form of Common Stock Purchase Warrant between CytRx Corporation
and each of the investors in the May 29, 2003 private
placement |
|
|
(s) |
|
|
4 |
.7 |
|
Form of Common Stock Purchase Warrant between CytRx Corporation
and each of the investors in the September 16, 2003 private
placement |
|
|
(v) |
|
|
4 |
.8 |
|
Warrant issued on May 10, 2004 to MBN Consulting, LLC |
|
|
(aa) |
|
|
4 |
.9 |
|
Form of Common Stock Purchase Warrant between CytRx Corporation
and each of the investors in the October 4, 2004 private
placement |
|
|
(dd) |
|
|
4 |
.10 |
|
Form of Common Stock Purchase Warrant between CytRx Corporation
and each of the investors in the January 2005 private placement |
|
|
(ee) |
|
|
5 |
.1 |
|
Opinion of Troy & Gould Professional Corporation |
|
|
|
|
|
10 |
.1 |
|
Agreement with Emory University, as amended |
|
|
(d) |
|
|
10 |
.2 |
|
Option Agreement granting PSMA Development Company option to
enter into a license agreement with CytRx Corporation dated
December 23, 2002 |
|
|
(q) |
|
|
10 |
.3* |
|
Amended and Restated Employment Agreement between CytRx
Corporation and Jack J. Luchese |
|
|
(i) |
|
|
10 |
.4* |
|
Amended and Restated Change of Control Employment Agreement
between CytRx Corporation and Jack J. Luchese |
|
|
(i) |
|
|
10 |
.5* |
|
Amendment No. 1 to Employment Agreement with Jack J. Luchese |
|
|
(k) |
|
|
10 |
.6* |
|
Amendment No. 1 to Change in Control Employment Agreement
with Jack J. Luchese |
|
|
(k) |
|
|
10 |
.7* |
|
1986 Stock Option Plan, as amended and restated |
|
|
(f) |
|
|
10 |
.8* |
|
1994 Stock Option Plan, as amended and restated |
|
|
(e) |
|
|
10 |
.9* |
|
1995 Stock Option Plan |
|
|
(g) |
|
|
10 |
.10* |
|
1998 Long-Term Incentive Plan |
|
|
(h) |
|
|
10 |
.11* |
|
2000 Long-Term Incentive Plan |
|
|
(k) |
|
|
10 |
.12* |
|
Amendment No. 1 to 2000 Long-Term Incentive Plan |
|
|
(m) |
|
56
|
|
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Footnote | |
| |
|
|
|
| |
|
10 |
.13* |
|
Amendment No. 2 to 2000 Long-Term Incentive Plan |
|
|
(m) |
|
|
10 |
.14* |
|
Amendment No. 3 to 2000 Long-Term Incentive Plan |
|
|
(x) |
|
|
10 |
.15* |
|
Amendment No. 4 to 2000 Long-Term Incentive Plan |
|
|
(x) |
|
|
10 |
.16 |
|
License Agreement dated November 1, 2000 by and between
CytRx Corporation and Merck & Co., Inc. |
|
|
(j) |
|
|
10 |
.17 |
|
License Agreement dated February 16, 2001 by and between
CytRx Corporation and Ivy Animal Health, Inc. |
|
|
(k) |
|
|
10 |
.18 |
|
License Agreement dated December 7, 2001 by and between
CytRx Corporation and Vical Incorporated |
|
|
(l) |
|
|
10 |
.19* |
|
Amended and Restated Employment Agreement dated as of May 2002
between CytRx Corporation and Steven A. Kriegsman |
|
|
(p) |
|
|
10 |
.20 |
|
Extension of financial advisory agreement between CytRx
Corporation and Cappello Capital Corp. dated January 1,
2002 Agreement between Kriegsman Capital Group and CytRx
Corporation dated |
|
|
(p) |
|
|
10 |
.21 |
|
February 11, 2002 regarding office space rental |
|
|
(p) |
|
|
10 |
.22 |
|
Marketing Agreement with Madison & Wall Worldwide, Inc.
dated August 14, 2002 |
|
|
(p) |
|
|
10 |
.23 |
|
Non-exclusive financial advisory agreement between CytRx
Corporation and Sands Brothers & Co. Ltd. dated
September 12, 2002 |
|
|
(p) |
|
|
10 |
.24 |
|
Agreement between Kriegsman Capital Group and CytRx Corporate
dated January 29, 2003 regarding office space rental and
shared services |
|
|
(r) |
|
|
10 |
.25 |
|
Consulting Agreement, dated February 21, 2003 between CytRx
Corporation and Corporate Capital Group International Ltd.
Inc. |
|
|
(r) |
|
|
10 |
.26 |
|
Securities Purchase Agreement, dated as of May 29, 2003,
between CytRx Corporation and the Purchasers identified on the
signatory page thereof |
|
|
(s) |
|
|
10 |
.27 |
|
Registration Rights Agreement, dated as of May 29, 2003,
between CytRx Corporation and the Purchasers identified on the
signature page thereof |
|
|
(s) |
|
|
10 |
.28 |
|
Non-Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering RNA sequence specific mediators of RNA
interference |
|
|
(t) |
|
|
10 |
.29 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering in vivo production of small interfering RNAs |
|
|
(t) |
|
|
10 |
.30 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering inhibitation of gene expression in
adipocytes using interference RNA |
|
|
(t) |
|
|
10 |
.31 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering RNAi targeting of viruses |
|
|
(t) |
|
|
10 |
.32 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering primary and polyvalent HIV-1 envelope
glycoprotein DNA vaccines |
|
|
(t) |
|
|
10 |
.33 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering gene based therapeutics for solid tumor
treatments |
|
|
(t) |
|
|
10 |
.34 |
|
Exclusive License Agreement dated as of April 15, 2003
between University of Massachusetts Medical School and CytRx
Corporation covering selective silencing of a dominant ALS gene
by RNAi |
|
|
(t) |
|
|
10 |
.35 |
|
Investment Banking Agreement dated April 1, 2003 between
Rockwell Asset Management Inc. and CytRx Corporation |
|
|
(u) |
|
57
|
|
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Footnote | |
| |
|
|
|
| |
|
10 |
.36 |
|
Investment Banking Agreement dated April 3, 2003 between
J.P. Turner & Company, LLC and CytRx Corporation |
|
|
(u) |
|
|
10 |
.37 |
|
First Amendment to Investment Banking Agreement dated
June 4, 2003 between J.P. Turner & Company, LLC
and CytRx Corporation |
|
|
(u) |
|
|
10 |
.38 |
|
Exclusive Financial Advisor Engagement Agreement dated
May 16, 2003 between Cappello Capital Corp. and CytRx
Corporation |
|
|
(u) |
|
|
10 |
.39 |
|
Modification letter dated June 6, 2003 to Engagement
Agreement between Cappello Capital Corp. and CytRx Corporation |
|
|
(u) |
|
|
10 |
.40 |
|
Engagement Letter dated May 27, 2003 between Cardinal
Securities, LLC and CytRx Corporation |
|
|
(u) |
|
|
10 |
.41* |
|
Second Amended and Restated Employment Agreement dated
June 10, 2003 between Steven A. Kriegsman and CytRx
Corporation |
|
|
(u) |
|
|
10 |
.42 |
|
Financial Consulting Agreement dated May 10, 2003 between
James Skalko and CytRx Corporation |
|
|
(u) |
|
|
10 |
.43 |
|
Form of Securities Purchase Agreement, dated as of
September 15, 2003, between CytRx Corporation and the
Purchasers identified on the signatory page thereof |
|
|
(v) |
|
|
10 |
.44 |
|
Form of Registration Rights Agreement, dated as of
September 15, 2003, between CytRx Corporation and the
Purchasers identified on the signature page thereof |
|
|
(v) |
|
|
10 |
.45 |
|
Amended and Restated License Agreement dated as of
September 15, 2003 between University of Massachusetts
Medical School and CytRx Corporation covering inhibition of gene
expression in adipocytes using interference RNA, certain data
bases, the use of endoplasmic reticulum stress response pathway
of adipose cells to enhance whole body insulin sensitivity, and
receptor-activated reporter systems |
|
|
(w) |
|
|
10 |
.46 |
|
Second Amendment to Investment Banking Agreement dated as of
August 13, 2003 between J.P. Turner & Company, LLC
and CytRx Corporation |
|
|
(w) |
|
|
10 |
.47* |
|
Agreement dated as of July 17, 2003 between Dr. Louis
J. Ignarro and CytRx Corporation |
|
|
(w) |
|
|
10 |
.48* |
|
Employment Agreement dated as of August 1, 2003 between
C. Kirk Peacock and CytRx Corporation |
|
|
(w) |
|
|
10 |
.49* |
|
Employment Agreement dated as of September 17, 2003 between
Mark A. Tepper and Araios, Inc. |
|
|
(w) |
|
|
10 |
.50 |
|
Agreement of Settlement and Release dated August 8, 2003
among Corporate Capital Group International Ltd., Inc, Peter
Simone and CytRx Corporation |
|
|
(w) |
|
|
10 |
.51 |
|
Confirming letter dated September 19, 2003 to the
engagement agreement dated May 16, 2003 between Cappello
Capital Corp. and CytRx Corporation |
|
|
(w) |
|
|
10 |
.52 |
|
Preferred Stock Purchase Agreement dated as of
September 16, 2003 between Araios, Inc. and CytRx
Corporation |
|
|
(w) |
|
|
10 |
.53 |
|
Stockholders Agreement dated as of September 17, 2003 among
Araios, Inc., Dr. Michael Czech and CytRx Corporation |
|
|
(w) |
|
|
10 |
.54 |
|
Private Placement Agent Agreement dated September 15, 2003
between Dunwoody Brokerage Services, Inc. and CytRx Corporation |
|
|
(w) |
|
|
10 |
.55 |
|
Private Placement Agent Agreement dated September 15, 2003
between Gilford Securities Incorporated and CytRx Corporation |
|
|
(w) |
|
|
10 |
.56 |
|
Agreement dated as of September 16, 2003 between Maxim
Group, LLC and CytRx Corporation |
|
|
(w) |
|
|
10 |
.57 |
|
Amended and Restated Professional Services Agreement among CytRx
Corporation, The Kriegsman Group and Kriegsman Capital Group,
dated as of July 1, 2003 |
|
|
(x) |
|
|
10 |
.58 |
|
Agreement among University of Massachusetts, Advanced BioScience
Laboratories, Inc. and CytRx Corporation, dated as of
December 3, 2003 |
|
|
(x) |
|
58
|
|
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Footnote | |
| |
|
|
|
| |
|
10 |
.59 |
|
Amended and Restated Exclusive License Agreement among
University of Massachusetts Medical School, CytRx Corporation
and Advanced BioScience Laboratories, Inc., dated as of
December 22, 2003 |
|
|
(x) |
|
|
10 |
.60 |
|
Collaboration Agreement among University of Massachusetts,
Advanced BioScience Laboratories, Inc. and CytRx Corporation,
dated as of December 22, 2003 |
|
|
(x) |
|
|
10 |
.61 |
|
Sublicense Agreement between CytRx Corporation and Advanced
BioScience Laboratories, Inc., dated as of December 22, 2003 |
|
|
(x) |
|
|
10 |
.62 |
|
Agreement between CytRx Corporation and Dr. Robert Hunter
regarding SynthRx, Inc. dated October 20, 2003 |
|
|
(x) |
|
|
10 |
.63 |
|
Office Lease between The Kriegsman Group and Douglas Emmett,
dated April 13, 2000 |
|
|
(x) |
|
|
10 |
.64 |
|
Assignment to CytRx Corporation effective July 1, 2003 of
Office Lease between The Kriegsman Group and Douglas Emmett,
dated April 13, 2000 |
|
|
(x) |
|
|
10 |
.65* |
|
Amendment dated October 18, 2003 to Agreement between
Dr. Louis J. Ignarro and CytRx Corporation dated as of
July 17, 2003 |
|
|
(x) |
|
|
10 |
.66 |
|
Consulting Agreement dated December 1, 2003 between CytRx
Corporation and MBN Consulting, LLC |
|
|
(x) |
|
|
10 |
.67 |
|
Office Lease between Araios, Inc. and Are-One Innovation Drive,
LLC dated 11-19-03 |
|
|
(x) |
|
|
10 |
.68 |
|
Registration Rights Agreement, dated as of January 29,
2004, by and between CytRx Corporation and Advanced BioScience
Laboratories, Inc. |
|
|
(y) |
|
|
10 |
.69 |
|
Consulting Agreement, dated as of February 9, 2004, between
CytRx Corporation and The Investor Relations Group, Inc. |
|
|
(y) |
|
|
10 |
.70 |
|
Investment Banking Agreement, dated as of
February , 2004, between CytRx Corporation and
Gunn Allen Financial, Inc. |
|
|
(y) |
|
|
10 |
.71 |
|
Scientific Advisory Board Agreement, effective as of
March 3, 2004, by Tariq M. Rana, Ph.D., CytRx
Corporation and Araios, Inc. |
|
|
(y) |
|
|
10 |
.72 |
|
Scientific Advisory Board Agreement, effective as of
March 3, 2004, by Craig Mello, Ph.D., CytRx
Corporation and Araios, Inc. |
|
|
(y) |
|
|
10 |
.73 |
|
Patent License Agreement, dated May, 2004, among CytRx
Corporation, Imperial College of Science and Technology and
Imperial College Innovations Limited |
|
|
(z) |
|
|
10 |
.74* |
|
Mutual General Release and Severance Agreement, dated
May 12, 2004, between CytRx Corporation and C. Kirk Peacock |
|
|
(z) |
|
|
10 |
.75* |
|
Mutual General Release and Severance Agreement, dated May12,
2004, between CytRx Corporation and Gregory Liberman |
|
|
(z) |
|
|
10 |
.76 |
|
Settlement and Release Agreement dated May 10, 2004, by and
between MBN Consulting, LLC and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.77 |
|
Registration Rights Agreement dated May 10, 2004, by and
between MBN Consulting, LLC and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.78 |
|
Collaboration and Invention Disclosure Agreement dated
July 8, 2004, by and between the University of
Massachusetts, as represented solely by the Medical School at
its Worcester campus, and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.79* |
|
Employment Agreement dated July 6, 2004, by and between
Jack Barber and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.80* |
|
Employment Agreement dated July 12, 2004, by and between
Matthew Natalizio and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.81* |
|
Employment Agreement dated July 15, 2004, by and between
Benjamin Levin and CytRx Corporation |
|
|
(aa) |
|
|
10 |
.82 |
|
Mutual and General Release of All Claims effective as of
May 29, 2004, by and between Madison & Wall
Worldwide, Inc. and CytRx Corporation |
|
|
(aa) |
|
59
|
|
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
|
|
Footnote | |
| |
|
|
|
| |
|
10 |
.83 |
|
Registration Rights Agreement dated May , 2004,
by and between Madison & Wall Worldwide, Inc. and CytRx
Corporation |
|
|
(aa) |
|
|
10 |
.84 |
|
Investment Banking Agreement dated September 13, 2004, by
and between CytRx Corporation and J.P. Turner &
Company, LLC |
|
|
(bb) |
|
|
10 |
.85 |
|
Investment Banking Agreement dated September 30, 2004, by
and between CytRx Corporation and Rodman & Renshaw, LLC |
|
|
(cc) |
|
|
10 |
.86 |
|
Asset Sale and Purchase Agreement dated October 4, 2004, by
and among CytRx Corporation, Biorex Research &
Development, RT and BRX Research and Development Company
Ltd. |
|
|
(dd) |
|
|
10 |
.87 |
|
Securities Purchase Agreement dated as of October 4, 2004
among CytRx Corporation and the Purchasers identified on the
signatory page thereof |
|
|
(dd) |
|
|
10 |
.88 |
|
Registration Rights Agreement dated as of October 4, 2004
among CytRx Corporation and the Purchasers identified on the
signatory page thereof |
|
|
(dd) |
|
|
10 |
.89 |
|
Securities Purchase Agreement, dated as of January 20,
2005, by and among CytRx Corporation and the Investors named
therein |
|
|
(ee) |
|
|
10 |
.90 |
|
Registration Rights Agreement, dated as of January 20,
2005, by and among CytRx Corporation and the Investors named
therein |
|
|
(ee) |
|
|
10 |
.91 |
|
Investment Banking Agreement dated January 20, 2005 between
CytRx Corporation and Rodman & Renshaw, LLC |
|
|
(ee) |
|
|
14 |
.1 |
|
Code of Ethics |
|
|
(x) |
|
|
21 |
.1 |
|
Subsidiaries |
|
|
(x) |
|
|
23 |
.1 |
|
Consent of BDO Seidman, LLP |
|
|
|
|
|
23 |
.2 |
|
Consent of Ernst & Young LLP |
|
|
|
|
|
31 |
|
|
Certifications Pursuant to 15 U.S.C. Section 7241, as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002 |
|
|
|
|
|
32 |
|
|
Certifications Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002 |
|
|
|
|
|
|
* |
Indicates a management contract or compensatory plan or
arrangement. Confidential treatment has been requested or
granted for certain portions which have been blanked out in the
copy of the exhibit filed with the Securities and |
|
|
Exchange Commission. The omitted information has been filed
separately with the Securities and Exchange Commission. |
|
|
(a) |
Incorporated by reference to the Registrants Registration
Statement on Form S-3 (File No. 333-39607) filed on
November 5, 1997 |
|
|
(b) |
Incorporated by reference to the Registrants Registration
Statement on Form S-8 (File No. 333-37171) filed on
July 21, 1997 |
|
|
(c) |
Incorporated by reference to the Registrants Current
Report on Form 8-K filed on April 21, 1997 |
|
(d) |
Incorporated by reference to the Registrants Registration
Statement on Form S-l (File No. 33-8390) filed on
November 5, 1986 |
|
(e) |
Incorporated by reference to the Registrants Quarterly
Report on Form 10-Q filed on November 13, 1997 |
|
(f) |
Incorporated by reference to the Registrants Annual Report
on Form 10-K filed on March 27, 1996 |
|
(g) |
Incorporated by reference to the Registrants Registration
Statement on Form S-8 (File No. 33-93818) filed on
June 22, 1995 |
|
(h) |
Incorporated by reference to the Registrants Annual Report
on Form 10-K filed on March 30, 1998 |
|
(i) |
Incorporated by reference to the Registrants Annual Report
on Form 10-K filed on March 30, 2000 |
60
|
|
(j) |
Incorporated by reference to the Registrants Current
Report on Form 8-K/ A filed on March 16, 2001 |
|
(k) |
Incorporated by reference to the Registrants Annual Report
on Form 10-K filed on March 27, 2001 |
|
(l) |
Incorporated by reference to the Registrants Current
Report on Form 8-K filed on December 21, 2001 |
|
(m) |
Incorporated by reference to the Registrants Proxy
Statement filed June 10, 2002 |
|
(n) |
Incorporated by reference to the Registrants Form S-8
(File No. 333-91068) filed on June 24, 2002 |
|
(o) |
Incorporated by reference to the Registrants 8-K filed on
August 1, 2002 |
|
(p) |
Incorporated by reference to the Registrants 10-Q filed on
November 14, 2002 |
|
(q) |
Incorporated by reference to the Registrants 10-K filed on
March 31, 2003 |
|
(r) |
Incorporated by reference to the Registrants 10-Q filed on
May 15, 2003 |
|
(s) |
Incorporated by reference to the Registrants 8-K filed on
May 30, 2003 Incorporated by reference to the
Registrants S-3 Amendment No. 4 (File
No. 333-100947) filed on |
|
(t) |
August 5, 2003 |
|
(u) |
Incorporated by reference to the Registrants 10-Q filed on
August 14, 2003 |
|
(v) |
Incorporated by reference to the Registrants 8-K filed on
September 17, 2003 |
|
(w) |
Incorporated by reference to the Registrants 10-Q filed on
November 12, 2003 |
|
(x) |
Incorporated by reference to the Registrants 10-K filed on
May 14, 2004 |
|
(y) |
Incorporated by reference to the Registrants 10-Q filed on
May 17, 2004 Incorporated by reference to the
Registrants Post-Effective Amendment No. 1 to
Registration Statement on Form S-1 to Form S-3 (Reg.
No. 333-109708) filed on June (z) 2, 2004 |
|
(aa) |
Incorporated by reference to the Registrants 10-Q filed on
August 16, 2004 |
|
|
(bb) |
Incorporated by reference to the Registrants 8-K filed on
September 17, 2004 |
|
|
(cc) |
Incorporated by reference to the Registrants 10-Q filed on
November 3, 2004 |
|
|
(dd) |
Incorporated by reference to the Registrants 8-K filed on
October 5, 2004 |
|
|
(ee) |
Incorporated by reference to the Registrants 8-K filed on
January 21, 2005 |
61
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.
|
|
|
|
By: |
/s/ Steven A. Kriegsman
|
|
|
|
|
|
Steven A. Kriegsman |
|
President and Chief Executive Officer |
Date: March 30, 2005
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/ Steven A. Kriegsman
Steven
A. Kriegsman |
|
President and Chief Executive
Officer and Director |
|
March 30, 2005 |
|
/s/ Matthew Natalizio
Matthew
Natalizio |
|
Chief Financial Officer and Treasurer (principal financial
and
accounting officer) |
|
March 30, 2005 |
|
/s/ Louis J. Ignarro,
Ph.D
Louis
J. Ignarro, Ph.D |
|
Director |
|
March 30, 2005 |
|
/s/ Max Link
Max
Link |
|
Director |
|
March 30, 2005 |
|
/s/ Joseph Rubinfeld,
Ph.D
Joseph
Rubinfeld, Ph.D |
|
Director |
|
March 30, 2005 |
|
/s/ Marvin R. Selter
Marvin
R. Selter |
|
Director |
|
March 30, 2005 |
|
/s/ Richard L.
Wennekamp
Richard
L. Wennekamp |
|
Director |
|
March 30, 2005 |
62
INDEX TO FINANCIAL STATEMENTS
AND FINANCIAL STATEMENT SCHEDULE
|
|
|
|
|
|
CytRx Corporation
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-22 |
|
Financial Statement Schedule
|
|
|
|
|
|
|
|
|
F-24 |
|
F-1
CYTRX CORPORATION
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
1,987,595 |
|
|
$ |
11,644,446 |
|
|
Short-term investments
|
|
|
1,011,814 |
|
|
|
|
|
|
Prepaid compensation, current portion
|
|
|
604,750 |
|
|
|
|
|
|
Prepaid and other current assets
|
|
|
351,396 |
|
|
|
236,349 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
3,955,555 |
|
|
|
11,880,795 |
|
|
|
|
|
|
|
|
Equipment and furnishings, net
|
|
|
447,579 |
|
|
|
227,413 |
|
|
|
|
|
|
|
|
Molecular library
|
|
|
447,567 |
|
|
|
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
|
|
|
|
Prepaid and other assets
|
|
|
198,055 |
|
|
|
216,076 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
5,048,756 |
|
|
$ |
12,324,284 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
1,661,104 |
|
|
$ |
738,135 |
|
|
Accrued expenses and other current liabilities
|
|
|
1,074,146 |
|
|
|
381,977 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,735,250 |
|
|
|
1,120,112 |
|
Accrued loss on facility abandonment
|
|
|
206,833 |
|
|
|
312,433 |
|
Deferred gain on sale of building
|
|
|
65,910 |
|
|
|
93,836 |
|
Deferred revenue
|
|
|
275,000 |
|
|
|
275,000 |
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
3,282,993 |
|
|
|
1,801,381 |
|
|
|
|
|
|
|
|
Minority interest
|
|
|
170,671 |
|
|
|
330,287 |
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $.01 par value, 5,000,000 shares
authorized, including 5,000 shares of Series A Junior
Participating Preferred Stock; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 100,000,000 shares
authorized; 40,190,000 and 34,392,000 shares issued at
December 31, 2004 and 2003, respectively
|
|
|
40,190 |
|
|
|
34,392 |
|
|
Additional paid-in capital
|
|
|
110,028,327 |
|
|
|
102,239,460 |
|
|
Treasury stock, at cost (633,816 shares held, at cost, at
December 31, 2004 and 2003)
|
|
|
(2,279,238 |
) |
|
|
(2,279,238 |
) |
|
Accumulated deficit
|
|
|
(106,194,187 |
) |
|
|
(89,801,998 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,595,092 |
|
|
|
10,192,616 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
5,048,756 |
|
|
$ |
12,324,284 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated balance sheets.
F-2
CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
22,453 |
|
|
License fees
|
|
|
428,164 |
|
|
|
94,000 |
|
|
|
1,051,000 |
|
|
Grant revenue
|
|
|
|
|
|
|
|
|
|
|
46,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
428,164 |
|
|
|
94,000 |
|
|
|
1,119,597 |
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues
|
|
|
|
|
|
|
|
|
|
|
11,287 |
|
|
Research and development (includes non-cash stock compensation
of $1,387,645 and $2,902,484 in 2004 and 2003, respectively)
|
|
|
6,012,903 |
|
|
|
4,387,599 |
|
|
|
767,102 |
|
|
In-process research and development
|
|
|
3,021,952 |
|
|
|
|
|
|
|
|
|
|
Common stock, stock options and warrants issued for selling,
general and administrative
|
|
|
1,977,330 |
|
|
|
3,148,047 |
|
|
|
229,550 |
|
|
Selling, general and administrative
|
|
|
5,923,910 |
|
|
|
3,840,620 |
|
|
|
1,703,402 |
|
|
Depreciation and amortization
|
|
|
103,851 |
|
|
|
2,130 |
|
|
|
793,563 |
|
|
Severance and other contractual payments to officers
|
|
|
|
|
|
|
|
|
|
|
1,822,454 |
|
|
Asset impairment charge
|
|
|
|
|
|
|
|
|
|
|
920,939 |
|
|
Loss on facility abandonment
|
|
|
|
|
|
|
|
|
|
|
477,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,039,946 |
|
|
|
11,378,396 |
|
|
|
6,725,983 |
|
|
|
|
|
|
|
|
|
|
|
Loss before other income
|
|
|
(16,611,782 |
) |
|
|
(11,284,396 |
) |
|
|
(5,606,386 |
) |
Other income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
59,977 |
|
|
|
82,064 |
|
|
|
95,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,551,805 |
) |
|
|
(11,202,332 |
) |
|
|
(5,510,878 |
) |
Equity in losses from minority-owned entity
|
|
|
|
|
|
|
(6,662,031 |
) |
|
|
(664,758 |
) |
Minority interest in losses of subsidiary
|
|
|
159,616 |
|
|
|
19,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(16,392,189 |
) |
|
$ |
(17,844,600 |
) |
|
$ |
(6,175,636 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share
|
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.39 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average shares outstanding
|
|
|
34,325,636 |
|
|
|
27,324,794 |
|
|
|
16,004,155 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-3
CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock | |
|
Additional | |
|
|
|
|
|
|
|
|
| |
|
Paid-In | |
|
Accumulated | |
|
Treasury | |
|
|
|
|
Shares Issued | |
|
Amount | |
|
Capital | |
|
Deficit | |
|
Stock | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2001
|
|
|
11,459,012 |
|
|
$ |
11,459 |
|
|
$ |
74,632,292 |
|
|
$ |
(65,781,762 |
) |
|
$ |
(2,279,238 |
) |
|
$ |
6,582,751 |
|
|
Issuance of common stock
|
|
|
324,999 |
|
|
|
326 |
|
|
|
109,408 |
|
|
|
|
|
|
|
|
|
|
|
109,734 |
|
|
Common stock issued for Acquisition of Global Genomics
|
|
|
8,948,204 |
|
|
|
8,948 |
|
|
|
5,785,014 |
|
|
|
|
|
|
|
|
|
|
|
5,793,962 |
|
|
Common stock and warrants issued in conjunction with acquisition
of Global Genomics
|
|
|
548,330 |
|
|
|
548 |
|
|
|
899,693 |
|
|
|
|
|
|
|
|
|
|
|
900,241 |
|
|
Common stock issued in lieu of cash for officers severance and
bonuses
|
|
|
863,382 |
|
|
|
863 |
|
|
|
517,882 |
|
|
|
|
|
|
|
|
|
|
|
518,745 |
|
|
Issuance of stock options/warrants
|
|
|
|
|
|
|
|
|
|
|
229,550 |
|
|
|
|
|
|
|
|
|
|
|
229,550 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,175,636 |
) |
|
|
|
|
|
|
(6,175,636 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
22,143,927 |
|
|
|
22,144 |
|
|
|
82,173,839 |
|
|
|
(71,957,398 |
) |
|
|
(2,279,238 |
) |
|
|
7,959,347 |
|
|
Issuance of common stock for research and development
|
|
|
1,828,359 |
|
|
|
1,828 |
|
|
|
2,550,606 |
|
|
|
|
|
|
|
|
|
|
|
2,552,434 |
|
|
Common stock and warrants issued in connection with private
placements
|
|
|
7,081,025 |
|
|
|
7,081 |
|
|
|
12,485,543 |
|
|
|
|
|
|
|
|
|
|
|
12,492,624 |
|
|
Issuance of common stock for services
|
|
|
700,000 |
|
|
|
700 |
|
|
|
1,534,050 |
|
|
|
|
|
|
|
|
|
|
|
1,534,750 |
|
|
Issuance of stock options/warrants
|
|
|
|
|
|
|
|
|
|
|
1,613,297 |
|
|
|
|
|
|
|
|
|
|
|
1,613,297 |
|
|
Options and warrants exercised
|
|
|
2,638,689 |
|
|
|
2,639 |
|
|
|
1,882,125 |
|
|
|
|
|
|
|
|
|
|
|
1,884,764 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,844,600 |
) |
|
|
|
|
|
|
(17,844,600 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
34,392,000 |
|
|
|
34,392 |
|
|
|
102,239,460 |
|
|
|
(89,801,998 |
) |
|
|
(2,279,238 |
) |
|
|
10,192,616 |
|
|
Common stock and warrants issued in connection with private
placements
|
|
|
4,100,000 |
|
|
|
4,100 |
|
|
|
3,899,900 |
|
|
|
|
|
|
|
|
|
|
|
3,904,000 |
|
|
Issuance of common stock for services
|
|
|
800,000 |
|
|
|
800 |
|
|
|
1,252,950 |
|
|
|
|
|
|
|
|
|
|
|
1,253,750 |
|
|
Issuance of stock options/warrants
|
|
|
|
|
|
|
|
|
|
|
2,111,225 |
|
|
|
|
|
|
|
|
|
|
|
2,111,225 |
|
|
Options and warrants exercised
|
|
|
897,688 |
|
|
|
898 |
|
|
|
524,792 |
|
|
|
|
|
|
|
|
|
|
|
525,690 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,392,189 |
) |
|
|
|
|
|
|
(16,392,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
40,189,688 |
|
|
$ |
40,190 |
|
|
$ |
110,028,327 |
|
|
$ |
(106,194,187 |
) |
|
$ |
(2,279,238 |
) |
|
$ |
1,595,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-4
CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(16,392,189 |
) |
|
$ |
(17,844,600 |
) |
|
$ |
(6,175,636 |
) |
|
Adjustments to reconcile net loss to net cash (used in) provided
by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
103,851 |
|
|
|
2,130 |
|
|
|
793,563 |
|
|
|
Equity in losses from minority-owned entity
|
|
|
|
|
|
|
6,662,031 |
|
|
|
664,758 |
|
|
|
Minority interest in losses of subsidiary
|
|
|
(159,616 |
) |
|
|
(19,763 |
) |
|
|
|
|
|
|
Stock option and warrant expense
|
|
|
1,104,730 |
|
|
|
1,613,297 |
|
|
|
229,550 |
|
|
|
Common stock issued for services
|
|
|
872,600 |
|
|
|
1,534,750 |
|
|
|
|
|
|
|
Non-cash research and development
|
|
|
1,387,645 |
|
|
|
2,902,484 |
|
|
|
|
|
|
|
Asset impairment charge
|
|
|
|
|
|
|
|
|
|
|
920,939 |
|
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note receivable
|
|
|
16,608 |
|
|
|
365,249 |
|
|
|
122,467 |
|
|
|
|
Prepaid and other assets
|
|
|
(768,433 |
) |
|
|
14,123 |
|
|
|
(379,849 |
) |
|
|
|
Accounts payable
|
|
|
922,969 |
|
|
|
658,188 |
|
|
|
(98,830 |
) |
|
|
|
Other liabilities
|
|
|
558,643 |
|
|
|
(181,044 |
) |
|
|
395,222 |
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
4,038,997 |
|
|
|
13,551,445 |
|
|
|
2,647,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(12,353,192 |
) |
|
|
(4,293,155 |
) |
|
|
(3,527,816 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of short-term investments
|
|
|
(961,765 |
) |
|
|
|
|
|
|
(1,401,358 |
) |
|
Redemption of short-term investments
|
|
|
|
|
|
|
1,401,358 |
|
|
|
|
|
|
Net cash paid related to acquisition
|
|
|
|
|
|
|
|
|
|
|
(615,064 |
) |
|
Purchases of property and equipment
|
|
|
(771,584 |
) |
|
|
(228,459 |
) |
|
|
|
|
|
Disposals of property and equipment, net
|
|
|
|
|
|
|
|
|
|
|
30,142 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(1,733,349 |
) |
|
|
1,172,899 |
|
|
|
(1,986,280 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
4,429,690 |
|
|
|
14,377,388 |
|
|
|
628,496 |
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(9,656,851 |
) |
|
|
11,257,132 |
|
|
|
(4,885,600 |
) |
|
Cash and cash equivalents at beginning of year
|
|
|
11,644,446 |
|
|
|
387,314 |
|
|
|
5,272,914 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$ |
1,987,595 |
|
|
$ |
11,644,446 |
|
|
$ |
387,314 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-5
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
CytRx Corporation (CytRx or the Company)
is a biopharmaceutical research and development company, based
in Los Angeles, California, with a development-stage subsidiary,
CytRx Laboratories, Inc. (the Subsidiary), based in
Worcester, Massachusetts (see Note 11). The Companys
small molecule therapeutics efforts include the clinical
development of three, oral drug candidates that it acquired in
October 2004, as well as a drug discovery operation conducted by
the Subsidiary. The Company owns the rights to a portfolio of
technologies, including ribonueleic acid interference (RNAi or
gene silencing) technology in the treatment of specified
diseases, including those within the areas of amyotrophic
lateral sclerosis (ALS or Lou Gehrigs disease), obesity
and type 2 diabetes and human cytomegalovirus (CMV), as well as
a DNA-based HIV vaccine technology and a cancer therapeutic
technology. In addition, the Company has entered into strategic
alliances with third parties to develop several of the
Companys other products.
On October 4, 2004, CytRx acquired all of the clinical and
pharmaceutical and related intellectual property assets of
Biorex Research & Development, RT, or Biorex, a
Hungary-based company focused on the development of novel small
molecules with broad therapeutic applications in neurology,
diabetes and cardiology. The acquired assets include three oral,
clinical stage drug candidates and a library of 500 small
molecule drug candidates. The acquisition positions CytRx as a
clinical-stage company with a Phase II trial for ALS with
one of its new compounds, arimoclomol, expected to be initiated
by the second quarter of 2005.
To date, the Company has relied primarily upon selling equity
securities and, to a lesser extent, upon payments from its
strategic partners and licensees to generate the funds needed to
finance its operations. Management believes the Companys
cash and cash equivalents balances will be sufficient to meet
cash requirements into the second quarter of 2006. The Company
will be required to obtain additional funding in order to
execute its long-term business plans. The Company cannot assure
that additional funding will be available on favorable terms, or
at all. If the Company fails to obtain significant additional
funding when needed, it may not be able to execute its business
plans and its business may suffer, which would have a material
adverse effect on its financial position, results of operations
and cash flows.
|
|
2. |
Summary of Significant Accounting Policies |
Basis of Presentation and Principles of
Consolidation The consolidated financial
statements include the accounts of CytRx together with those of
its majority-owned subsidiaries. The accounts of the Subsidiary
are included since September 17, 2003 (see Note 11).
The accounts of Global Genomics are included since July 19,
2002 (see Note 12).
Revenue Recognition Service revenues relate
to recruiting services rendered and are recognized at the time
services are rendered because all obligations necessary to earn
such revenues have been completed by the Company at that time.
Revenues from collaborative research arrangements and grants are
generally recorded as the related costs are incurred. The costs
incurred under such arrangements are recorded as research and
development expense and approximate the revenues reported in the
accompanying statements of operations. Non-refundable license
fee revenue is recognized when collectibility is reasonably
assured, which is generally upon receipt, when no continuing
involvement of the Company is required and payment of the
license fee represents the culmination of the earnings process.
Non-refundable license fees received subject to future
performance by the Company or that are credited against future
payments due to the Company are deferred and recognized as
services are performed and collectibility is reasonably assured,
which is generally upon receipt, or recognized upon termination
of the agreement and all related obligations thereunder.
Cash Equivalents The Company considers all
highly liquid debt instruments with an original maturity of
90 days or less to be cash equivalents. Cash equivalents
consist primarily of amounts invested in money market accounts.
F-6
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Investments Management determines the
appropriate classification of debt securities at the time of
purchase. Debt securities are classified as held-to-maturity
when the Company has the positive intent and ability to hold the
securities to maturity. Held-to-maturity securities are stated
at amortized cost. Marketable equity securities and debt
securities not classified as held-to-maturity are classified as
available-for-sale. Available-for-sale securities are carried at
fair value, with the unrealized gains and losses reported as a
separate component of stockholders equity. Realized gains
and losses are included in investment income and are determined
on a first-in, first-out basis.
Fair Value of Financial Instruments The
carrying amounts reported in the balance sheet for cash and cash
equivalents, short-term investments, notes receivable and
accounts payable approximate their fair values.
Property and Equipment Property and equipment
are stated at cost and depreciated using the straight-line
method based on the estimated useful lives (generally five years
for equipment and furniture) of the related assets. Whenever
there is a triggering event that might suggest an impairment,
management evaluates the realizability of recorded long-lived
assets to determine whether their carrying values have been
impaired. The Company records impairment losses on long-lived
assets used in operations when events and circumstances indicate
that the assets might be impaired and the nondiscounted cash
flows estimated to be generated by those assets are less than
the carrying amount of those assets. Any impairment loss is
measured by comparing the fair value of the asset to its
carrying amount.
Patents and Patent Application Costs Although
the Company believes that its patents and underlying technology
have continuing value, the amount of future benefits to be
derived therefrom is uncertain. Patent costs are therefore
expensed rather than capitalized.
Basic and Diluted Loss per Common Share Basic
and diluted loss per common share are computed based on the
weighted average number of common shares outstanding. Common
share equivalents (which consist of options, warrants and
convertible Subsidiary common stock) are excluded from the
computation of diluted loss per share since the effect would be
antidilutive. Common share equivalents which could potentially
dilute basic earnings per share in the future, and which were
excluded from the computation of diluted loss per share, totaled
approximately 14.5 million shares, 10.1 million shares
and 6.7 million shares at December 31, 2004, 2003 and
2002, respectively.
Shares Reserved for Future Issuance As of
December 31, 2004, the Company has reserved approximately
5,488,974 of its authorized but unissued shares of common stock
for future issuance pursuant to its employee stock option plans
and warrants issued to consultants and investors.
Stock-based Compensation The Company grants
stock options and warrants for a fixed number of shares to key
employees and directors with an exercise price equal to the fair
market value of the shares at the date of grant. The Company
accounts for stock option grants and warrants in accordance with
Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees
(APB 25) and related interpretations, and,
accordingly, recognizes no compensation expense for the stock
option grants and warrants issued to employees for which the
terms are fixed. For stock option grants and warrants which vest
based on certain corporate performance criteria, compensation
expense is recognized to the extent that the quoted market price
per share exceeds the exercise price on the date such criteria
are achieved or are probable. Statement of Financial Accounting
Standards (SFAS) No. 123, Accounting for
Stock-based Compensation (SFAS 123), provides
an alternative to APB 25 in accounting for stock-based
compensation issued to employees. However, the Company has
continued to account for stock-based compensation for employees
in accordance with APB 25 (See Note 14). The Company
has also granted stock options and warrants to certain
consultants and other third parties. Stock options and warrants
granted to consultants and other third parties are accounted for
in accordance with SFAS 123 and related interpretations and
are valued at the fair market value of the options and warrants
granted or the services received, whichever is more reliably
measurable.
F-7
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Expense is recognized in the period in which a performance
commitment exists or the period in which the services are
received, whichever is earlier.
SFAS 123, as amended by SFAS No. 148, Accounting
for Stock-Based Compensation Transition and
Disclosure (SFAS 148), requires the
presentation of pro forma information as if the Company had
accounted for its employee stock options and performance awards
under the fair value method of that statement. For purposes of
pro forma disclosure, the estimated fair value of the options
and performance awards at the date of the grant is amortized to
expense over the vesting period. The following table illustrates
the effect on net loss and loss per share if the Company had
applied the fair value recognition provisions of SFAS 123
to stock-based employee compensation (amounts in thousands
except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss, as reported
|
|
$ |
(16,392 |
) |
|
$ |
(17,845 |
) |
|
$ |
(6,176 |
) |
Total stock-based employee compensation expense determined under
fair value-based method for all awards
|
|
|
(1,376 |
) |
|
|
(928 |
) |
|
|
(1,229 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(17,768 |
) |
|
$ |
(18,773 |
) |
|
$ |
(7,405 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share, as reported (basic and diluted)
|
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.39 |
) |
Loss per share, pro forma (basic and diluted)
|
|
$ |
(0.52 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.46 |
) |
The fair value for the Companys options and warrants was
estimated at the date of grant using a Black-Scholes option
pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Weighted average risk free interest rate
|
|
|
4.25 |
% |
|
|
2.82 |
% |
|
|
2.74 |
% |
Dividend yields
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Volatility factors of the expected market price of the
Companys common stock
|
|
|
1.09 |
|
|
|
0.99 |
|
|
|
0.99 |
|
Weighted average years outstanding
|
|
|
5.8 |
|
|
|
5.1 |
|
|
|
3.6 |
|
The Black-Scholes option valuation model was developed for use
in estimating the fair value of traded options which have no
vesting restrictions and are fully transferable. In addition,
option valuation models require the input of highly subjective
assumptions including the expected stock price volatility.
Because the Companys employee stock options have
characteristics significantly different from those of traded
options, and because changes in the subjective input assumptions
can materially affect the fair value estimate, in
managements opinion, the existing models do not
necessarily provide a reliable single measure of the fair value
of its warrants and employee stock options.
Research and Development Expenses Research
and development expenses consist of costs incurred for direct
and overhead-related research expenses and are expensed as
incurred. Costs to acquire technologies which are utilized in
research and development and which have no alternative future
use are expensed when incurred. Technology developed for use in
our products is expensed as incurred until technological
feasibility has been established. Expenditures to date have been
classified as research and development expense.
Income Taxes Income taxes are accounted for
using an asset and liability approach that requires the
recognition of deferred tax assets and liabilities for the
expected future tax consequences of events that have been
recognized in the Companys financial statements or tax
returns. A valuation allowance is established to reduce deferred
tax assets if all, or some portion, of such assets will more
than likely not be realized.
Concentrations of Credit Risk Financial
instruments that potentially subject the Company to significant
concentrations of credit risk consist principally of cash and
cash equivalents, short-term investments and note receivable.
The Company maintains cash and cash equivalents in large
well-capitalized financial
F-8
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
institutions and the Companys investment policy disallows
investment in any debt securities rated less than
investment-grade by national ratings services. The
Company has not experienced any losses on its deposits of cash
and cash equivalents. The Company is at risk to the extent
accounts receivable and note receivable amounts become
uncollectible.
Use of Estimates The preparation of the
financial statements in conformity with accounting principles
generally accepted in the United States of America requires
management to make estimates and assumptions that affect the
amounts reported in the financial statements and accompanying
notes. Actual results could differ materially from those
estimates.
Segment Information Management uses
consolidated financial information in determining how to
allocate resources and assess financial performance. For this
reason, the Company has determined that it is principally
engaged in one industry segment.
|
|
3. |
Recent Accounting Pronouncements |
Recently Issued Accounting Standards In
December 2004, the Financial Accounting Standards Board
(FASB) revised and issued SFAS 123, Share-Based
Payment (SFAS 123(R)). SFAS 123(R) eliminates the
alternative of using the APB 25 intrinsic value method of
accounting for stock options. This revised statement will
require recognition of the cost of employee services received in
exchange for awards of equity instruments based on the fair
value of the award at the grant date. This cost is required to
be recognized over the vesting period of the award. The
stock-based compensation table in Note 2 illustrates the
effect on net income and earnings per share if we had applied
the fair value recognition provisions of SFAS 123 to
stock-based employee compensation. SFAS 123(R) applies to
all awards granted, modified, repurchased, or cancelled after
June 30, 2005. We will early-adopt SFAS 123(R)
effective January 1, 2005, using the modified prospective
method. As a result of the adoption of this statement, our
compensation expense for share-based payments is expected to be
approximately $1.5 million in 2005.
At December 31, 2004 the Company held approximately
$1.0 million in short-term investments. At
December 31, 2003 the Company did not have any investments.
The contractual maturities of securities held at
December 31, 2004 were one year or less. At
December 31, 2004, the Company classified all of its
investments (consisting entirely of Certificates of Deposit) as
held-to-maturity. The fair market value approximated the
carrying costs and gross unrealized and realized gains/ losses
were immaterial.
At December 31, 2004 and 2003, the Company held
approximately $51,000 and $50,000, respectively, in investments
(consisting entirely of Certificates of Deposit), reported in
Prepaid and Other Current Assets in the accompanying
consolidated balance sheets. The contractual maturities of
securities held at December 31, 2004 were one year or less.
At December 31, 2004 and 2003, the investments were pledged
as collateral for a letter of credit for the same amount issued
in connection with one of the Companys lease agreements.
F-9
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Property and Equipment |
Property and equipment at December 31 consist of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Equipment and furnishings
|
|
$ |
554 |
|
|
$ |
229 |
|
Less accumulated depreciation
|
|
|
(106 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
Equipment and furnishings, net
|
|
|
448 |
|
|
|
227 |
|
Molecular library
|
|
|
447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$ |
895 |
|
|
$ |
227 |
|
|
|
|
|
|
|
|
At December 31, 2004, the molecular library had been
purchased, but had not been placed in service by the Company,
because the compounds had not been physically received.
Therefore, no amortization of the related patents was recorded
in fiscal 2004.
Asset Impairment Loss In May 2002,
Organichem, Corp., which was to provide CytRx with commercial
supplies of Flocor purified drug substance, advised CytRx that
it did not intend to renew the Companys agreement when it
expired in December 2003. During the fourth quarter of 2002, the
Company determined that, in light of the relatively short
remaining term of the Organichem contract, the significant costs
that would be associated with relocating the equipment owned by
CytRx in connection with this contract and the Companys
lack of success to date in its continuing search for a strategic
partner for the development of Flocor, an impairment loss of
approximately $921,000 should be recorded, which equals the then
net book value of this equipment and related leasehold
improvements. This charge is reflected as a separate line item
in the accompanying consolidated statement of operations for the
year ended December 31, 2002 as an asset impairment charge.
Accrued Expenses Accrued expenses and other
current liabilities at December 31, 2004 and 2003 are
summarized below (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred gain on sale of building (current portion)
|
|
$ |
28 |
|
|
$ |
28 |
|
Accrued loss on facility abandonment (current portion)
|
|
|
106 |
|
|
|
106 |
|
Professional fees
|
|
|
359 |
|
|
|
171 |
|
Research and development costs
|
|
|
140 |
|
|
|
|
|
Accrued bonuses
|
|
|
181 |
|
|
|
|
|
Accrued settlement fee
|
|
|
200 |
|
|
|
|
|
Other miscellaneous
|
|
|
60 |
|
|
|
77 |
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,074 |
|
|
$ |
382 |
|
|
|
|
|
|
|
|
In the fourth quarter of 2002, the Company recorded a loss of
approximately $478,000 associated with the closure of its
Atlanta headquarters and relocation to Los Angeles subsequent to
its merger with Global Genomics (see Note 12). This loss
represents the total remaining lease obligations and estimated
operating costs through the remainder of the lease term, less
estimated sublease income and is reflected in
Note 9 Commitments and Contingencies. This
accrued charge was combined with deferred rent of $85,000
already recorded, so that the total accrual related to the
facility abandonment was $563,000 as of December 31, 2002.
F-10
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As of December 31, 2004 and 2003, the accrued loss on
facility abandonment was $312,000, $105,000 of which was
reflected as a current liability and $207,000 as a non-current
liability. As of December 31, 2003, the accrued loss on
facility abandonment was $418,000, $106,000 of which was
reflected as a current liability and $312,000 as a non-current
liability. During 2004, the Company incurred expenditures
totaling $210,000 for the abandoned facility and utilized
$106,000 of the accrual related to the facility abandonment.
During 2003, the Company incurred expenditures totaling $224,000
for the abandoned facility and utilized $145,000 of the accrual
related to the facility abandonment.
|
|
9. |
Commitments and Contingencies |
Minimum annual future obligations under operating leases,
minimum annual future obligations under various license
agreements and minimum annual future obligations under
employment agreements consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating | |
|
License | |
|
Employment | |
|
|
|
|
Leases | |
|
Agreements | |
|
Agreements | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
2005
|
|
$ |
573 |
|
|
$ |
2,363 |
|
|
$ |
1,008 |
|
|
$ |
3,944 |
|
2006
|
|
|
342 |
|
|
|
1,149 |
|
|
|
740 |
|
|
|
2,231 |
|
2007
|
|
|
229 |
|
|
|
226 |
|
|
|
240 |
|
|
|
695 |
|
2008
|
|
|
76 |
|
|
|
330 |
|
|
|
240 |
|
|
|
646 |
|
2009
|
|
|
|
|
|
|
330 |
|
|
|
|
|
|
|
330 |
|
2010 and thereafter
|
|
|
|
|
|
|
990 |
|
|
|
|
|
|
|
990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,220 |
|
|
$ |
5,388 |
|
|
$ |
2,228 |
|
|
$ |
8,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Under the various license agreements and sponsored research
agreements with University of Massachusetts Medical School
(UMMS) (see Note 17) and other institutions,
CytRx will be required to make annual license maintenance
payments as well as milestone payments, ranging from
$11 million to $14 million per approved product, to
UMMS and/or other institutions based on the development of
products utilizing the licensed technology and will be required
to pay royalties, based on future sales of those products, which
will generally range from 3% to 7.5% of such sales, depending
upon the product and the technology being utilized. In
connection with the sponsored research agreements, CytRx agreed
to fund certain pre-clinical research at UMMS and other
institutions related to the use of CytRxs licensed
technologies for the development of therapeutic products.
The Company has employment agreements with its executive
officers, the terms of which expire at various times through
July 2006. Certain agreements, which have been revised from time
to time, provide for minimum salary levels, adjusted annually at
the Compensation Committees determination, as well as for
minimum bonuses that are payable. The reported commitment for
employment agreements includes, among other things, a total of
$1.0 million of compensation payable to members of
CytRxs Scientific Advisory Board, and a total of
$1.2 million of salary and guaranteed bonuses payable to
CytRxs executives.
Rent expense under operating leases during 2004, 2003 and 2002
was approximately $260,000, $258,000 and $171,000, respectively.
|
|
10. |
Private Placements of Common Stock |
In October 2004, the Company entered into a Stock Purchase
Agreement with a group of institutional and other investors (the
October 2004 Investors). The October 2004 Investors
purchased, for an aggregate purchase price of $4.0 million,
4,000,000 shares of the Companys common stock and
warrants to purchase an additional 3,080,000 shares of the
Companys common stock, at $1.69 per share, expiring
in 2009. After
F-11
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
consideration of offering expenses, net proceeds to the Company
were approximately $3.7 million. The shares and the shares
underlying the warrants issued to the October 2004 Investors
were subsequently registered. In addition, the Company issued
approximately $204,000 worth of common stock in January 2004.
In September 2003, the Company entered into a Stock Purchase
Agreement with a group of institutional and other investors (the
September 2003 Investors). The September 2003
Investors purchased, for an aggregate purchase price of
$8.7 million , 4,140,486 shares of the Companys
common stock and warrants to purchase an additional
1,035,125 shares of the Companys common stock, at
$3.05 per share, expiring in 2008. After consideration of
offering expenses, net proceeds to the Company were
approximately $7.7 million. The shares and the shares
underlying the warrants issued to the September 2003 Investors
were subsequently registered.
In May 2003, the Company entered into a Stock Purchase Agreement
with a group of institutional investors (the May 2003
Investors). The May 2003 Investors purchased, for an
aggregate purchase price of $5.4 million ,
2,940,539 shares of the Companys common stock and
warrants to purchase an additional 735,136 shares of the
Companys common stock, at $3.05 per share, expiring
in 2008. After consideration of offering expenses, net proceeds
to the Company were approximately $4.8 million. The shares
and the shares underlying the warrants issued to the May 2003
Investors were subsequently registered.
|
|
11. |
Investment in Subsidiary |
On September 17, 2003, CytRx purchased 2,000 shares of
convertible preferred stock for $7 million, representing a
95% ownership interest in the Subsidiary. The Subsidiary is a
newly formed entity that plans to develop orally active small
molecule based drugs to prevent, treat and cure obesity and
type 2 diabetes. This funding was provided out of the
proceeds of CytRxs private placement financing that was
completed in September 2003. Since September 17, 2003,
CytRx has consolidated the Subsidiary, based on CytRxs
ability to control the stockholders votes and the Board of
Directors of the Subsidiary, and recorded a minority interest
liability of $350,000, representing the 5% interest in the
Subsidiary held by Dr. Michael Czech (see Note 19).
Prior to September 17, 2003, the Subsidiary had no
operations. Additionally, the Company has recorded the fair
value of 300,000 shares of its common stock as additional
paid-in capital for the Companys right to call and
Dr. Czechs right to put his remaining 5% interest in
the Subsidiary to CytRx in exchange for a guaranteed amount of
300,000 shares of CytRx common stock. The fair value of
these shares on the purchase date was approximately $723,000. In
addition, upon the occurrence of certain events, Dr. Czech
may receive up to an additional 350,000 shares of CytRx
common stock.
In connection with the investment in the Subsidiary, CytRx
acquired the rights to certain in-process research and
development related to obesity and type 2 diabetes, which
was owned by Dr. Czech. Because the in-process research and
development acquired was not yet technologically feasible, CytRx
recorded research and development expense of $1,073,000.
|
|
12. |
Merger with Global Genomics |
On February 11, 2002, CytRx entered into an agreement to
acquire Global Genomics, a privately-held genomics holding
company, through a merger of GGC Merger Corporation, a
wholly-owned subsidiary of CytRx, into Global Genomics. Global
Genomics is a genomics holding company that currently has a 40%
ownership interest in Blizzard and a 5% ownership interest in
Psynomics. CytRxs primary reasons for the acquisition were
to (a) expand its business into the genomics field to
diversify its product and technology base, and (b) gain the
management and directors of Global Genomics, who could assist
CytRx in developing corporate partnerships and acquisition,
investment and financing opportunities not previously available
to CytRx.
F-12
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The transaction closed on July 19, 2002, after approval by
the stockholders of each company and satisfaction of other
customary closing conditions. Pursuant to the merger agreement,
each outstanding share of common stock of Global Genomics was
converted into .765967 shares of the Companys common
stock. The merger resulted in the issuance of
8,948,204 shares of the Companys common stock and
options and warrants to purchase 1,014,677 shares of
the Companys common stock to the former security holders
of Global Genomics, with 498,144 shares of the
Companys common stock being held in escrow and subject to
cancellation in whole or in part to satisfy any indemnification
claims made by the Company under the merger agreement. These
shares were released from escrow in 2003. CytRx issued an
additional 548,330 shares of its Common Stock for
investment banking and legal fees as part of the merger.
The merger was accounted for as a purchase by CytRx of a group
of assets of Global Genomics in a transaction other than a
business combination and was not considered to be a reverse
acquisition. The Company considered the provisions of Statement
of Financial Accounting Standards No. 141, Business
Combinations (SFAS 141) and determined CytRx to
be the acquiror for accounting purposes. Because the current
activities of Global Genomics were focused on the development of
a business rather than the operation of a business and planned
principal operations of Global Genomics had not yet commenced,
Global Genomics was considered a development-stage company.
Therefore, in accordance with the guidance in Emerging Issues
Task Force Issue No. 98-3 (EITF 98-3),
Determining Whether a Nonmonetary Transaction Involves
Receipt of Productive Assets or of a Business, Global
Genomics did not constitute a business as defined in
SFAS 141. Therefore, the Company allocated the purchase
price in accordance with the provisions of Statement of
Financial Accounting Standards No. 142, Goodwill and Other
Intangible Assets (SFAS 142) related to the
purchase of a group of assets. SFAS 142 provides that the
cost of a group of assets acquired in a transaction other than a
business combination shall be allocated to the individual assets
acquired based on their relative fair values and shall not give
rise to goodwill.
The purchase price was determined in accordance with
SFAS 141 and SFAS 142. A summary of the determination
of the purchase price is as follows:
|
|
|
|
|
Issuance of 8,948,204 shares of CytRx common stock at
$0.6475 per share
|
|
$ |
5,793,962 |
|
Fair value of 1,014,677 vested warrants issued to purchase CytRx
common stock
|
|
|
598,659 |
|
Transaction costs
|
|
|
971,869 |
|
|
|
|
|
Total purchase price
|
|
$ |
7,364,490 |
|
|
|
|
|
Since Global Genomics was a development-stage company and no
goodwill can arise from the purchase of a development-stage
company, in accordance with the provisions of SFAS 141 and
SFAS 142, all identifiable assets acquired, including
identifiable intangible assets, were assigned a portion of the
purchase price on the basis of their relative fair values. To
this end, an independent appraisal of Global Genomics
assets was used as an aid in determining the fair value of the
identifiable assets, including identified intangible assets, in
allocating the purchase price among the acquired assets.
F-13
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Global Genomics primary assets were its investments in
Blizzard and Psynomics and thus, the fair value of each of these
entities was determined. The discounted cash flow approach was
used to determine the estimated fair value of the acquired
intangible assets of Blizzard and Psynomics underlying Global
Genomics investment in each company. Cash flows were
projected for a period of 10 years and were discounted to
net present value using discount factors of 46% to 60%. Material
cash inflows from product sales were projected to begin in 2003
for Blizzard. A summary of the purchase price allocation is as
follows:
|
|
|
|
|
Current assets
|
|
$ |
33,129 |
|
Investment in minority-owned entity acquired
developed technology
|
|
|
7,309,250 |
|
In-process research and development (recognized as an expense)
|
|
|
78,394 |
|
Less: Liabilities assumed
|
|
|
(56,283 |
) |
|
|
|
|
Total purchase price
|
|
$ |
7,364,490 |
|
|
|
|
|
The in-process research and development was recorded as a charge
for acquired incomplete research and development in the
accompanying consolidated statement of operations and relates
primarily to Global Genomics investment in Psynomics. The
acquired developed technology primarily represents values
assigned to Global Genomics investment in Blizzards
DNA chip reader, thermal gradient station and T-Chips. The
acquired technology was being amortized over a period of ten
years until 2003, when CytRx wrote off its investment in
Blizzard. The ten-year amortization period was determined
through consideration of relevant patent terms (legal life),
estimated technological and economic life, and the range of
useful lives observed in public filings of other companies
involved in similar DNA technologies.
Equity in Losses of Blizzard. The Company recorded its
portion of the losses of Blizzard using the equity method. The
equity in losses of Blizzard and the amortization of the
acquired developed technology are reported as a separate line
item in the accompanying consolidated statement of operations.
Impairment Test of Intangible Assets. In accordance with
the provisions of Accounting Principles Board Opinion
No. 18, The Equity Method of Accounting for Investments in
Common Stock (APB 18), the Company reviewed the
net values on its balance sheet as of September 30, 2003
assigned to Investment in Minority Owned
Entity Acquired Developed Technology resulting from
its acquisition of Global Genomics. APB 18 requires that a
loss in value of an investment, which is other than a temporary
decline, should be recognized as an impairment loss. Through the
third quarter of 2003, Blizzard had been unsuccessful in its
attempts to raise a significant amount of the financing
necessary for it to pursue the commercialization strategy for
its products.
CytRxs analysis consisted of a review of current financial
projections prepared by Blizzard, application of a discounted
cash flow valuation model of Blizzards projected cash
flows, and consideration of other qualitative factors. Based
upon the quantitative and qualitative factors described above
and in addition to others, CytRxs management determined
that the estimated fair value of CytRxs investment in
Blizzard was $0 and that an impairment charge of $5,868,000 was
necessary in 2003.
As of December 31, 2003, the following assets related to
Blizzard were reflected in CytRxs balance sheets:
|
|
|
|
|
Investment in minority owned entity acquired
developed technology
|
|
$ |
7,309,250 |
|
Receivable from Blizzard
|
|
|
16,640 |
|
Less: Accumulated amortization
|
|
|
(883,311 |
) |
Less: Equity-method losses to date
|
|
|
(574,381 |
) |
Less: Impairment charge
|
|
|
(5,868,198 |
) |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
F-14
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In addition, $16,640 of receivable from Blizzard was recorded in
prepaid and other current assets as of December 31, 2002.
|
|
13. |
Severance Payments to Officers |
In accordance with a Mutual General Release and Severance
Agreement in May 2004, the Company agreed to pay the
Companys former General Counsel, approximately $87,500 and
12 months of related benefits, and agreed to immediately
vest options to purchase 87,500 shares of its common
stock that were granted upon the commencement of his employment.
In accordance with a Mutual General Release and Severance
Agreement in May 2004, the Company agreed to pay the
Companys former Chief Financial Officer, approximately
$150,000 and 18 months of related benefits, and agreed to
immediately vest options to purchase 105,000 shares of its
common stock that were granted upon the commencement of his
employment.
Pursuant to his employment agreement, CytRxs former
President and CEO (Former CEO) was entitled to a
payment of $435,150 upon the execution of the merger agreement
between CytRx and Global Genomics (see Note 11) and an
additional $435,150 upon the closing of the merger. In order to
reduce the amount of cash that CytRx had to pay to the Former
CEO, CytRx and the Former CEO agreed that approximately $325,200
of the first $435,150 payment would be satisfied by CytRx
granting a stock award to the Former CEO under the CytRx
Corporation 2000 Long-Term Incentive Plan under which CytRx
issued the Former CEO 558,060 shares of the Companys
common stock. Those shares of stock were issued at a value equal
to 85% of the volume weighted average price of CytRx common
stock for the 20 trading days ended on February 8, 2002.
The cash payment and fair value of the shares issued were
recognized as expense during the first quarter of 2002.
The terms of CytRxs merger with Global Genomics
contemplated that Global Genomics management team would
replace that of CytRxs subsequent to the closing of the
merger. On July 16, 2002, CytRx terminated the employment
of all of its then-current officers, resulting in total
obligations for severance, stay bonuses, accrued vacation and
other contractual payments of $1,394,000 (including the final
$435,150 owed to the Former CEO). Prior to the merger closing
date, CytRx advanced part of these amounts to three of its
officers, such that the total remaining obligation at the
closing date was $1,179,000. Four officers agreed to accept an
aggregate total of $177,000 of such amount in the form of the
Companys common stock, in lieu of cash, resulting in the
issuance of 248,799 shares. Thus, the net cash payout in
satisfaction of these obligations was $1,002,000, before taxes.
The severance payments and fair value of the shares issued were
recognized as expense during the third quarter of 2002 and is
reported as a separate line item on the accompanying
consolidated statement of operations together with the cash
payment and fair value of shares issued to the Former CEO
discussed above.
|
|
14. |
Stock Options and Warrants |
CytRx has stock option plans pursuant to which certain key
employees, directors and consultants are eligible to receive
incentive and/or nonqualified stock options to purchase shares
of CytRxs common stock. Fixed options granted under the
plans generally become exercisable over a three-year period from
the dates of grant and have lives of ten years. The Company may
also grant stock options and/or warrants to its Chief Executive
Officer and other executive officers containing alternative or
additional vesting provisions based on the achievement of
corporate objectives. Exercise prices of all stock options and
warrants for employees and directors are set at the fair market
values of the common stock on the dates of grant.
In connection with the Companys private equity financing
that was consummated on October 4, 2004, the Company
repriced warrants to purchase approximately 2.8 million
shares of its common stock, as a result of anti-dilution
provisions in those warrants that were triggered by the
Companys issuance of common stock in that equity financing
at a price below the closing market price on the date of the
transaction. As a result of the modification, these warrants are
required to be accounted for as variable options under
APB 25 and related
F-15
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Interpretations. Pursuant to the anti-dilution provision, the
exercise price of those warrants was reduced from between $1.85
and $3.05 per share, to between $1.78 and $2.94 per
share, and the number of shares underlying the warrants was
increased to approximately 2.9 million.
In connection with the Companys acquisition of Global
Genomics in July 2002 (see Note 12), CytRx issued 1,014,677
warrants to the holders of Global Genomics warrants in return
for the cancellation of all of their outstanding Global Genomics
warrants. The new warrants were 100% vested upon their issuance,
have an exercise price of $0.01 per share and expire on
January 31, 2007. Additionally, the acquisition of Global
Genomics triggered the Change of Control provisions
contained in the Companys stock option plans and in the
warrants held by the Companys Former CEO, resulting in the
immediate vesting of all outstanding warrants held by the Former
CEO and of all outstanding stock options issued pursuant to the
Companys various stock options plans.
During 2004, 2003 and 2002, services were received in exchange
for stock options and warrants issued to certain consultants,
resulting in aggregate non-cash charges of $1.1 million,
$1.6 million and $230,000, respectively.
A summary of the Companys stock option and warrant
activity and related information for the years ended
December 31 is shown below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average | |
|
|
Stock Options and Warrants | |
|
Exercise Price | |
|
|
| |
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Outstanding beginning of year
|
|
|
10,130,119 |
|
|
|
6,626,826 |
|
|
|
5,532,478 |
|
|
$ |
1.58 |
|
|
$ |
1.00 |
|
|
$ |
1.22 |
|
Granted
|
|
|
6,202,778 |
|
|
|
8,074,917 |
|
|
|
1,752,178 |
|
|
|
1.61 |
|
|
|
1.95 |
|
|
|
0.32 |
|
Exercised
|
|
|
(1,031,439 |
) |
|
|
(2,900,881 |
) |
|
|
(200,000 |
) |
|
|
0.75 |
|
|
|
0.78 |
|
|
|
0.01 |
|
Forfeited
|
|
|
(785,000 |
) |
|
|
(875,000 |
) |
|
|
(275,000 |
) |
|
|
2.13 |
|
|
|
0.35 |
|
|
|
0.80 |
|
Expired
|
|
|
(40,000 |
) |
|
|
(795,743 |
) |
|
|
(182,830 |
) |
|
|
1.69 |
|
|
|
2.30 |
|
|
|
1.28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of year
|
|
|
14,476,458 |
|
|
|
10,130,119 |
|
|
|
6,626,826 |
|
|
|
1.73 |
|
|
|
1.74 |
|
|
|
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
11,872,314 |
|
|
|
7,402,886 |
|
|
|
6,559,326 |
|
|
$ |
1.69 |
|
|
$ |
1.58 |
|
|
$ |
1.00 |
|
Weighted average fair value of stock options and warrants
granted during the year:
|
|
$ |
1.36 |
|
|
$ |
0.78 |
|
|
$ |
0.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes additional information concerning
stock options and warrants outstanding and exercisable at
December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options and Warrants | |
|
|
Stock Options and Warrants Outstanding | |
|
Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted Average | |
|
|
|
|
|
|
|
|
Remaining | |
|
|
|
Number of | |
|
|
|
|
Number of | |
|
Contractual Life | |
|
Weighted Average | |
|
Shares | |
|
Weighted Average | |
Range of Exercise Prices |
|
Shares | |
|
(years) | |
|
Exercise Price | |
|
Exercisable | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.01
|
|
|
459,352 |
|
|
|
2.1 |
|
|
$ |
0.01 |
|
|
|
459,352 |
|
|
$ |
0.01 |
|
|
0.20 - 1.05
|
|
|
2,636,912 |
|
|
|
4.7 |
|
|
|
0.78 |
|
|
|
2,606,910 |
|
|
|
0.78 |
|
|
1.06 - 1.79
|
|
|
4,748,171 |
|
|
|
5.5 |
|
|
|
1.59 |
|
|
|
4,285,171 |
|
|
|
1.63 |
|
|
1.80 - 2.67
|
|
|
4,668,246 |
|
|
|
8.2 |
|
|
|
2.08 |
|
|
|
2,557,104 |
|
|
|
2.08 |
|
|
2.68 - 2.94
|
|
|
1,963,777 |
|
|
|
3.7 |
|
|
|
2.94 |
|
|
|
1,963,777 |
|
|
|
2.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,476,458 |
|
|
|
5.8 |
|
|
$ |
1.73 |
|
|
|
11,872,314 |
|
|
$ |
1.69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-16
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
15. |
Stockholder Protection Rights Plan |
Effective April 16, 1997, the Companys Board of
Directors declared a distribution of one right
(Rights) for each outstanding share of the
Companys common stock to stockholders of record at the
close of business on May 15, 1997 and for each share of
common stock issued by the Company thereafter and prior to a
Flip-in Date (as defined below). Each Right entitles the
registered holder to purchase from the Company one-ten
thousandth (1/10,000th) of a share of Series A Junior
Participating Preferred Stock, at an exercise price of $30. The
Rights are generally not exercisable until 10 business days
after an announcement by the Company that a person or group of
affiliated persons (an Acquiring Person) has
acquired beneficial ownership of 15% or more of the
Companys then outstanding shares of common stock (a
Flip-in Date). In connection with the merger
agreement with Global Genomics, the Companys Board of
Directors amended the stockholders protection rights agreement
to exempt the merger from triggering a Flip-in Date.
In the event the Rights become exercisable as a result of the
acquisition of shares, each Right will enable the owner, other
than the Acquiring Person, to purchase at the Rights
then-current exercise price a number of shares of common stock
with a market value equal to twice the exercise price. In
addition, unless the Acquiring Person owns more than 50% of the
outstanding shares of common stock, the Board of Directors may
elect to exchange all outstanding Rights (other than those owned
by such Acquiring Person) at an exchange ratio of one share of
common stock per Right. All Rights that are owned by any person
on or after the date such person becomes an Acquiring Person
will be null and void.
The Rights have been distributed to protect the Companys
stockholders from coercive or abusive takeover tactics and to
give the Board of Directors more negotiating leverage in dealing
with prospective acquirors.
For income tax purposes, CytRx and its subsidiaries have an
aggregate of approximately $79.6 million of net operating
losses available to offset against future taxable income,
subject to certain limitations. Such losses expire in 2005
through 2023 as of December 31, 2004. CytRx also has an
aggregate of approximately $6.3 million of research and
development and orphan drug credits available for offset against
future income taxes that expire in 2005 through 2021.
Deferred income taxes reflect the net effect of temporary
differences between the financial reporting carrying amounts of
assets and liabilities and income tax carrying amounts of assets
and liabilities. The components of the Companys deferred
tax assets and liabilities, all of which are long-term, are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforward
|
|
$ |
30,231 |
|
|
$ |
27,047 |
|
|
Tax credit carryforward
|
|
|
6,363 |
|
|
|
6,628 |
|
|
Property and equipment and capital losses
|
|
|
4,559 |
|
|
|
5,488 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
41,153 |
|
|
|
39,163 |
|
Deferred tax liabilities Depreciation and other
|
|
|
(2,665 |
) |
|
|
(2,683 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
38,488 |
|
|
|
36,480 |
|
Valuation allowance
|
|
|
(38,488 |
) |
|
|
(36,480 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
F-17
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Based on assessments of all available evidence as of
December 31, 2004 and 2003, management has concluded that
the respective deferred income tax assets should be reduced by
valuation allowances equal to the amounts of the net deferred
income tax assets since it is managements conclusion that
it is more likely than not that the deferred tax assets will not
be realized. Furthermore, it is likely the July 19, 2002
acquisition of Global Genomics caused a change of ownership as
defined by Internal Revenue Code Section 382 which may
substantially limit the ability of the Company to utilize net
operating losses incurred prior to that date. Generally, the net
operating losses will be limited to an annual utilization of
approximately 4.9% of the purchase price of Global Genomics.
For all years presented, the Company did not recognize any
deferred tax assets or liabilities and deferred tax provision or
benefit.
The provision for income taxes differs from the provision
computed by applying the Federal statutory rate to net loss
before income taxes as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Federal benefit at statutory rate
|
|
$ |
(5,570 |
) |
|
$ |
(6,066 |
) |
|
$ |
(2,100 |
) |
State income taxes, net of Federal taxes
|
|
|
(655 |
) |
|
|
(1,070 |
) |
|
|
(371 |
) |
Permanent differences
|
|
|
1,103 |
|
|
|
1,200 |
|
|
|
319 |
|
Provision (benefit) related to change in valuation allowance
|
|
|
5,122 |
|
|
|
7,414 |
|
|
|
1,976 |
|
Other
|
|
|
|
|
|
|
(1,478 |
) |
|
|
176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
University of Massachusetts Medical School In
April 2003, CytRx acquired the rights to new technologies by
entering into exclusive license arrangements with the UMMS
covering potential applications of the medical
institutions proprietary gene silencing technology in the
treatment of specified diseases, including those within the
areas of obesity and type 2 diabetes, and amyotrophic lateral
sclerosis, commonly known as Lou Gehrigs disease (ALS),
human cytomegalovirus, and covering UMMSs proprietary
technology with potential gene therapy applications within the
area of cancer. In consideration of the licenses, CytRx made
cash payments to UMMS totaling approximately $186,000 and issued
it a total of 1,613,258 shares of CytRx common stock, which
were valued for financial statement purposes at approximately
$1,468,000. In May 2003, CytRx broadened its strategic alliance
with UMMS by acquiring an exclusive license from that
institution covering a proprietary DNA-based HIV vaccine
technology. In consideration of this license, CytRx made cash
payments to UMMS totaling approximately $18,000 and issued it
215,101 shares of CytRx common stock, which were valued for
financial statement purposes at approximately $361,000. In July
2004, CytRx further expanded its strategic alliance with UMMS by
entering into a collaboration and invention disclosure agreement
with UMMS under which UMMS will disclose to CytRx certain new
technologies developed at UMMS over the next three years
pertaining to RNAi, diabetes, obesity, neurodegenerative
diseases (including ALS) and CMV and will give CytRx an option,
upon making a specified payment, to negotiate an exclusive
worldwide license to the disclosed technologies on commercially
reasonable terms. As of December 31, 2004, CytRx had made
cash payments to UMMS totaling $187,500 pursuant to the
collaboration agreement with UMMS, but has not yet acquired or
made any payments to acquire any options under that agreement.
In May 2004, CytRx licensed from the technology transfer company
of the Imperial College of Science, Technology &
Medicine, or Imperial College, the exclusive rights to
intellectual property covering a drug
F-18
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
screening method using RIP 140, which is a nuclear hormone
co-repressor that is believed to regulate fat accumulation. In
consideration of the license, CytRx made cash payments to
Imperial College totaling $87,000 and issued it a total of
75,000 shares of CytRx common stock which were valued, for
financial statement purposes, at $108,000. As the drug screening
technology from Imperial College and the RNAi technology from
UMMS had not achieved technological feasibility at the time of
their license by CytRx, had no alternative future uses and,
therefore, no separate economic value, the total value of all
cash payments and stock issued for acquisition of the technology
was expensed as research and development in our financial
statements.
|
|
18. |
Quarterly Financial Data (unaudited) |
Summarized quarterly financial data for 2004 and 2003 is as
follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended | |
|
|
| |
|
|
March 31 | |
|
June 30 | |
|
September 30 | |
|
December 31 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$ |
100 |
|
|
$ |
228 |
|
|
$ |
|
|
|
$ |
100 |
|
Net loss
|
|
|
(3,774 |
) |
|
|
(4,061 |
) |
|
|
(2,796 |
) |
|
|
(5,761 |
) |
Basic and diluted loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(0.11 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
1 |
|
|
$ |
90 |
|
Net loss
|
|
|
(914 |
) |
|
|
(5,046 |
) |
|
|
(8,777 |
) |
|
|
(3,108 |
) |
Basic and diluted loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(0.04 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.09 |
) |
Quarterly and year to date loss per share amounts are computed
independently of each other. Therefore, the sum of the per share
amounts for the quarters may not agree to the per share amounts
for the year.
|
|
19. |
Related Party Transactions |
In July 2002, the Company entered into an agreement with
Kriegsman Capital Group (KCG), whereby KCG or its
affiliate The Kriegsman Group (TKG) agreed to
provide CytRx with office space and certain administrative
services. KCG and TKG are owned by Steven A. Kriegsman,
CytRxs President and CEO. During the years ended
December 31, 2003 and 2002, the Company made net payments
of $70,000 and $59,000, respectively, to KCG under this
agreement. The charges were determined based upon actual space
used and estimated percentages of employee time used. The
Company believes that such charges approximated the fair value
of the space and services provided. In October 2003, the
services and facilities agreement with KCG was terminated as
substantially all of the on-going operations of KCG have ceased.
The obligations under the facility lease at the Companys
headquarters were transferred from KCG to CytRx in July 2003 and
are reflected in Note 9 Commitments and
Contingencies.
Dr. Michael Czech, a 5% minority stockholder of the
Subsidiary (see Note 11) and a member of CytRxs and
the Subsidiarys Scientific Advisory Boards, is an employee
of UMMS and party, as the principal investigator, to a sponsored
research agreement between CytRx and UMMS. The Company recorded
a minority interest liability of $350,050, representing the 5%
interest in the Subsidiary held by Dr. Czech. Additionally,
the Company recorded the fair value of 300,000 shares of
its common stock as additional paid-in capital for the
Companys right to call and Dr. Czechs right to
put the remaining 5% interest in the Subsidiary
F-19
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
to CytRx in exchange for a guaranteed amount of
300,000 shares of CytRx common stock. The fair value of
these shares on the purchase date was approximately $723,000.
During 2003, Dr. Czech was paid $18,000 for his Scientific
Advisory Board services. In addition, upon the occurrence of
certain events, Dr. Czech may receive up to an additional
350,000 shares of CytRx common stock. During 2004 and 2003,
CytRx paid UMMS $806,000 and $403,000, respectively, under the
sponsored research agreement to fund a portion of
Dr. Czechs research.
On January 20, 2005, the Company completed a
$21.3 million private equity financing in which we issued
17,334,494 shares of our common stock and warrants to
purchase an additional 8,667,247 shares of our common stock
at an exercise price of $2.00 per share. Net of investment
banking commissions, legal, accounting and other fees related to
the transaction, we received proceeds of approximately
$19.5 million. The following selected pro forma balance
sheet data is derived from our balance sheet as of
December 31, 2004 and gives effect to the completion of
that private equity financing, but does not give effect to other
events that
F-20
CYTRX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
occurred since December 31, 2004 and thus may not be
indicative of our current financial condition. The information
should be read in conjunction with our balance sheet as of
December 31, 2004 and related notes.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments Related | |
|
|
|
|
Actual as of | |
|
to January 2005 | |
|
Pro Forma as of | |
|
|
December 31, 2004 | |
|
Financing | |
|
December 31, 2004 | |
|
|
| |
|
| |
|
| |
|
|
(Audited) | |
|
(Unaudited) | |
|
(Unaudited) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and short-term investments
|
|
$ |
2,999,000 |
|
|
$ |
19,505,000 |
|
|
$ |
22,504,000 |
|
|
Prepaid and other current assets
|
|
|
956,000 |
|
|
|
|
|
|
|
956,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
3,955,000 |
|
|
|
19,505,000 |
|
|
|
23,460,000 |
|
Non-current assets
|
|
|
1,093,000 |
|
|
|
|
|
|
|
1,093,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
5,048,000 |
|
|
$ |
19,505,000 |
|
|
$ |
24,553,000 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Total liabilities
|
|
$ |
3,283,000 |
|
|
$ |
|
|
|
$ |
3,283,000 |
|
|
|
|
|
|
|
|
|
|
|
Minority interest in subsidiary
|
|
|
170,000 |
|
|
|
|
|
|
|
170,000 |
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.01 par value, 5,000,000 shares
authorized, including 5,000 shares of Series A Junior
Participating Preferred Stock; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value, 100,000,000 shares
authorized; 40,190,000 shares issued at December 31,
2004
|
|
|
40,000 |
|
|
|
17,000 |
|
|
|
57,000 |
|
Additional paid-in-capital
|
|
|
110,028,000 |
|
|
|
19,488,000 |
|
|
|
129,516,000 |
|
Treasury stock, at cost (633,816 shares)
|
|
|
(2,279,000 |
) |
|
|
|
|
|
|
(2,279,000 |
) |
Accumulated deficit
|
|
|
(106,194,000 |
) |
|
|
|
|
|
|
(106,194,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,595,000 |
|
|
|
19,505,000 |
|
|
|
21,100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
5,048,000 |
|
|
$ |
19,505,000 |
|
|
$ |
24,553,000 |
|
|
|
|
|
|
|
|
|
|
|
F-21
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors
CytRx Corporation
Los Angeles, California
We have audited the accompanying consolidated balance sheets of
CytRx Corporation and subsidiaries as of December 31, 2004
and 2003 and the related consolidated statements of operations,
stockholders equity and cash flows for the years then
ended. We have also audited the schedule listed in the
accompanying index. These financial statements and schedule are
the responsibility of the Companys management. Our
responsibility is to express an opinion on the financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included
consideration of internal control over financial reporting as a
basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the 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, and assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of CytRx Corporation and subsidiaries at
December 31, 2004 and 2003 and the results of their
operations and their cash flows for the years then ended, in
conformity with accounting principles generally accepted in the
United States of America. Also, in our opinion, the related
financial statement schedule, when considered in relation to the
basic financial statements taken as a whole, presents fairly in
all material respects the information set forth therein.
|
|
|
/s/ BDO Seidman, LLP |
|
|
|
BDO Seidman, LLP |
|
Los Angeles, California |
March 11, 2005
F-22
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
CytRx Corporation
We have audited the accompanying consolidated statements of
operations, stockholders equity, and cash flows of CytRx
Corporation for the year ended December 31, 2002. Our audit
also included the financial statement schedule listed in the
Index at Item 15(a). These financial statements and
schedule are the responsibility of the Companys
management. Our responsibility is to express an opinion on these
financial statements and schedule based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the
consolidated results of operations and cash flows for CytRx
Corporation for the year ended December 31, 2002, in
conformity with accounting principles generally accepted in the
United States. Also, in our opinion, the related financial
statement schedule, when considered in relation to the basic
financial statements taken as a whole, presents fairly in all
material respects the information set forth therein.
|
|
|
/s/ ERNST & YOUNG LLP |
|
|
|
Atlanta, Georgia |
March 25, 2003
F-23
CYTRX CORPORATION
SCHEDULE II VALUATION AND QUALIFYING
ACCOUNTS
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions | |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Balance at | |
|
Charged to | |
|
Charged to | |
|
|
|
|
|
|
Beginning of | |
|
Costs and | |
|
Other | |
|
|
|
Balance at | |
Description |
|
Period | |
|
Expenses | |
|
Accounts | |
|
Deductions | |
|
End of Period | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Reserve Deducted in the Balance Sheet from the Asset to Which it
Applies:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Bad Debts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2004
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
Year ended December 31, 2003
|
|
|
|
|
|
|
4,939 |
|
|
|
16,640 |
|
|
|
21,579 |
|
|
|
|
|
|
|
Year ended December 31, 2002
|
|
$ |
39,050 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
39,050 |
|
|
$ |
|
|
|
Allowance for Deferred Tax Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2004
|
|
$ |
36,478,000 |
|
|
$ |
|
|
|
$ |
2,008,000 |
|
|
$ |
|
|
|
$ |
38,488,000 |
|
|
|
Year ended December 31, 2003
|
|
|
29,064,000 |
|
|
|
|
|
|
|
7,414,000 |
|
|
$ |
|
|
|
|
36,478,000 |
|
|
|
Year ended December 31, 2002
|
|
$ |
27,088,000 |
|
|
$ |
|
|
|
$ |
1,976,000 |
|
|
|
|
|
|
$ |
29,064,000 |
|
F-24