LadRx Corp - Annual Report: 2008 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-K
(Mark
one)
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R
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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, 2008
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or
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£
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF
1934
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For
the transition period from ______________ to
______________
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Commission
file number 0-15327
CytRx
Corporation
(Exact
name of Registrant as specified in its charter)
Delaware
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58-1642740
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(State
or other jurisdiction of
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(I.R.S.
Employer
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incorporation
or organization)
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Identification
No.)
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11726
San Vicente Blvd, Suite 650,
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Los
Angeles, California
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90049
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s telephone number,
including area code: (310) 826-5648
________________
Securities registered pursuant to
Section 12(b) of the Act:
Title of each class
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Name of exchange on which
registered
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Common
Stock, $0.001 par value per share
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The
NASDAQ Stock Market LLC
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Series
A Junior Participating Preferred Stock Purchase Rights
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Securities Registered Pursuant to
Section 12(g) of the Act:
None
Indicate
by check mark if the Registrant is a well-known seasoned issuer (as defined in
Securities Act Rule 405). Yes £ No R
Indicate
by check mark if the Registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Securities Exchange Act of 1934.
Yes £ No R
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 R No £
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 Registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. R
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of
“large accelerated filer,” “accelerated filer” and “smaller reporting company”
in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer £
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Accelerated
filer R
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Non-accelerated
filer £
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Smaller
reporting company £
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(Do
not check if a smaller reporting company)
|
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule 2b-2
of the Act). Yes £ No R
The
aggregate market value of the Registrant’s common stock held by non-affiliates
on June 30, 2008, the last business day of the Registrant’s most recently
completed second fiscal quarter, was approximately $56.0 million. On March 11,
2009, there were outstanding 93,347,732 shares of the Registrant’s common stock,
exclusive of treasury shares.
CYTRX
CORPORATION
2007
ANNUAL REPORT ON FORM 10-K
TABLE
OF CONTENTS
Page
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3
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PART
I
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Item
1. BUSINESS
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4
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Item
1A. RISK FACTORS
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16
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Item
2. PROPERTIES
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28
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Item
3. LEGAL PROCEEDINGS
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28
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PART
II
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28
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Item
6. SELECTED FINANCIAL DATA
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31
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32
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43
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43
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Item
9A. CONTROLS AND PROCEDURES
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44
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PART
III
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45
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Item
11. EXECUTIVE COMPENSATION
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47
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62
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63
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64
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PART
IV
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66
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SIGNATURES
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69
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2
“SAFE HARBOR” STATEMENT
Some of
the information contained in this Annual Report may include forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, or the Securities Act, and Section 21E of the Securities Exchange Act
of 1934, as amended, or the Exchange Act. We base these forward-looking
statements on our current views with respect to our research and development
activities, business strategy, business plan, financial performance and other
matters, both with respect to us, specifically, and the biotechnology sector, in
general. Statements that include the words “expect,” “intend,” “plan,”
“believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and
similar statements of a future or forward-looking nature identify
forward-looking statements for purposes of the federal securities laws or
otherwise, but the absence of these words does not necessarily mean that a
statement is not forward-looking.
All
forward-looking statements involve inherent risks and uncertainties, and there
are or will be important factors that could cause actual results to differ
materially from those indicated in these statements. We believe that these
factors include, but are not limited to, those factors set forth in the sections
entitled “Business,” “Risk Factors,” “Legal Proceedings,” “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,”
“Quantitative and Qualitative Disclosures About Market Risk” and “Controls and
Procedures” in this Annual Report, all of which you should review carefully.
Please consider our forward-looking statements in light of those risks as you
read this Annual Report. We undertake no obligation to publicly update or review
any forward-looking statement, whether as a result of new information, future
developments or otherwise, except as required by law.
If one or
more of these or other risks or uncertainties materializes, or if our underlying
assumptions prove to be incorrect, actual results may vary materially from what
we anticipate. All subsequent written and oral forward-looking statements
attributable to us or individuals acting on our behalf are expressly qualified
in their entirety by the cautionary language above. You should consider
carefully all of the factors set forth or referred to in this Annual Report that
could cause actual results to differ.
3
PART
I
Item
1. BUSINESS
In this
Annual Report, we sometimes refer to CytRx Corporation as “CytRx,” to our former
subsidiary, RXi Pharmaceuticals Corporation, as “RXi,” and to Innovive
Pharmaceuticals, Inc., which we acquired in September 2008, as “Innovive.”
References in this Annual Report to the “company,” “we,” “us” or “our” refer to
CytRx, alone, unless otherwise indicated.
COMPANY
OVERVIEW
We are a
biopharmaceutical research and development company engaged in the development of
high-value human therapeutics. Our drug development pipeline includes two
product candidates in clinical development for cancer indications, including
registration studies of tamibarotene for the treatment of acute promyelocytic
leukemia, or APL. In addition to our core oncology programs, we are developing
treatments for neurodegenerative and other disorders based upon our
small-molecule molecular chaperone amplification technology. We also are engaged
in new-drug discovery research at our laboratory facility in San Diego,
California, utilizing our master chaperone regulator assay, or MaCRA,
technology. Apart from our drug development programs and new-drug discovery
research activities, we currently maintain a 45% equity interest in our former
subsidiary, RXi Pharmaceuticals Corporation, or RXi (NASDAQ: RXII).
On
September 19, 2008, we completed our merger acquisition of Innovive
Pharmaceuticals, Inc., or Innovive, and its clinical-stage cancer product
candidates, including tamibarotene. As a result of the merger, Innovive became a
wholly owned subsidiary of CytRx. On December 30, 2008, we merged the
former Innovive subsidiary into CytRx.
Prior to
our acquisition of Innovive, we were focused on developing human therapeutics
based primarily upon our small-molecule molecular chaperone amplification
technology, including arimoclomol for ALS and stroke recovery and iroxanadine
for diabetic foot ulcers and other potential indications. After
acquiring Innovive, we redirected our efforts from arimoclomol and iroxanadine
to developing Innovive’s former lead cancer product candidates, tamibarotene for
APL and INNO-206 for small cell lung cancer, SCLC, or other solid tumor cancers,
which we believe hold greater near-term revenue potential. Our
current business strategy is to seek one or more strategic partnerships for
the further
development of arimoclomol and iroxanadine.
OUR
PRODUCT CANDIDATE PIPELINE
The
following tables summarize the current pipeline of our product
candidates:
Technology
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Product Candidate
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Indication
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Stage of Development
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Synthetic
retinoid
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Tamibarotene
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APL
(acute promyelocytic leukemia)
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Pivotal
Phase II
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Doxorubicin
prodrug
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INNO-2006
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SCLC
(small cell lung cancer) and other solid tumor cancers
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Phase
II (2H-2009)
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Tyrosine
kinase inhibitor
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Bafetinib
(formerly INNO-406)
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CML
(chronic myeloid leukemia)
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Phase
I
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Molecular
chaperone amplification
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Arimoclomol
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ALS
(amyotrophic lateral sclerosis, or Lou Gehrig’s disease) and stroke
recovery
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Phase
IIb
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Molecular
chaperone amplification
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Iroxanadine
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Diabetic
foot ulcers, other indications
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Phase
I
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OUR
CLINICAL DEVELOPMENT PROGRAMS
Our
current clinical development programs consist of our efforts to develop
tamibarotene for APL and INNO-206 for SCLC or other solid tumor types and our
planned animal toxicology studies designed to facilitate a Phase IIb clinical study of
arimoclomol in ALS, which has been placed on hold by the United States Food and
Drug Administration, or FDA.
Tamibarotene. Tamibarotene
is a synthetic retinoid designed to overcome resistance and avoid toxic side
effects of differentiation therapy with all-trans retinoic acid, or ATRA, a
component of the current first-line treatment for APL.
4
Tamibarotene for the treatment of
APL. Acute promyelocytic leukemia, or APL, is a specific type
of acute myeloid leukemia characterized by the t(15;17) translocation, which
fuses the promyelocytic leukemia, or PML, gene on chromosome 15 to the retinoic
acid receptor, or RAR, a gene on chromosome
17. This fusion causes abnormal cell growth.
Differentiation
therapy with ATRA, is the basis for the treatment of APL. Differentiation
therapy causes leukemic promyelocytes to mature and undergo cell death. Patients
typically receive ATRA in combination with chemotherapy as the initial therapy, followed by
anthracyline-based consolidation therapy designed to produce complete remission.
The majority of patients treated this way generally experience a complete
remission of disease. Current National Comprehensive Cancer Network guidelines
recommend that patients then undergo one to two years of maintenance therapy
with ATRA to prevent a recurrence. ATRA therapy is associated with several
toxicities, the most serious of which, retinoic acid syndrome, or
RAS. RAS occurs in up to 25% of patients treated with ATRA, a serious
and potentially fatal complication characterized by fever, dyspnea (breathing
difficulties), weight gain, pulmonary infiltrates (abnormal accumulation in the
lungs), and pleural or pericardial effusions (excess fluid around the lungs or
heart).
Patients
that initially respond to front-line therapy with ATRA plus
chemotherapy sometimes relapse, and some of these patients fail to respond to a
second course of treatment with ATRA. Currently, patients who fail ATRA-based
therapy are treated with arsenic trioxide, a compound administered intravenously
and associated with significant toxicity, including irregular heartbeat. There
currently is no standard of care for patients who do not respond to ATRA and
arsenic trioxide, or who respond but subsequently relapse. In 2007, the FDA
granted Orphan Drug Designation and Fast Track Designation for the use of
tamibarotene in patients with relapsed or refractory APL following treatment
with ATRA and arsenic trioxide.
Tamibarotene
was developed to overcome resistance to ATRA. In vitro, tamibarotene is
approximately ten times more potent than ATRA at causing APL cells to
differentiate and die. In addition, tamibarotene has a lower affinity for
cellular retinoic acid binding protein, or CRABP, which we believe should allow
for sustained plasma levels during administration. This may enhance
tamibarotene’s potential efficacy, because patients may be able to experience
benefits from the drug over a longer period of
time. Tamibarotene does not bind the RAR-g receptor, the major
retinoic acid receptor in the dermal epithelium, which should lessen the
occurrence of RAS. In clinical studies, the rate of RAS appeared to be
low.
Pre-clinical
data. In a variety of preclinical models, tamibarotene was
superior to ATRA in its ability to cause APL cells to differentiate and die. In
the clinical setting, in vitro response to tamibarotene appeared predictive of
clinical response, including activity in patients who had a poor response to
ATRA.
Clinical
data. Tamibarotene is approved in Japan under the brand name
Amnolake for
use in relapsed or refractory APL. The approval was based on data from two
studies in Japanese patients. In the pivotal study, the effectiveness of orally
administered tamibarotene was evaluated in 39 patients with APL, including
patients who had never received treatment for APL and patients who had been
previously treated with ATRA. Tamibarotene was administered orally at a dose of
6 mg/m2/day for
eight weeks. The overall complete response rate in these patients was 61.5%. In
patients who had a recurrence of APL following ATRA therapy, the response rate
was 81%. RAS was reported in three patients, or 7.3% of the patient
group.
Development
Plan. We re-initiated a pivotal study in ATRA and arsenic
trioxide refractory APL in the second quarter of 2008. The study is designed to
collect pharmacokinetic, safety and efficacy data in approximately 50 patients.
We anticipate that this study will take approximately 15 months to complete.
Depending on its outcome, this study, in combination with the data from the two
Japanese studies, would form the basis of a new drug application, or NDA. If the
results of the study are positive, and if we are able to manufacture
tamibarotene in commercial quantities in compliance with stringent regulatory
requirements, we believe that we would be able to file the NDA with the FDA in
2011.
In
addition, a Phase III study is currently being conducted in Japan by the Japan
Adult Leukemia Group comparing ATRA to tamibarotene for the maintenance
treatment of APL. If positive, these data could potentially form the basis of a
supplemental NDA application.
INNO-206. INNO-206
(formerly DOXO-EMCH) is a prodrug for doxorubicin. Specifically, it is the
(6-Maleimidocaproyl) hydrazone of doxorubicin. Essentially, this chemical is
doxorubicin (DOXO) attached to an acid sensitive linker (EMCH).
INNO-206 for the Treatment of
Cancer. Anthracyclines are a class of drugs that are among the
most commonly used agents in the treatment of cancer. Doxorubicin, the first
anthracycline to gain FDA approval, has demonstrated efficacy in a wide variety
of cancers including breast cancer, lung cancer, sarcomas, and lymphomas.
However, due to the uptake of doxorubicin by various parts of the
5
body, it is associated with side effects such as cumulative
cardiotoxicity, myelosuppression (decreased production of blood cells by bone
marrow), gastrointestinal disorders, mucositis (inflammation of the mucous
membranes lining the digestive tract, including the mouth), stomatitis
(inflammation of the mouth’s soft tissue), and extravasation (the leakage of
intravenous drugs from the vein into the surrounding tissue).
We
believe INNO-206 has attributes that improve on native doxorubicin, including
reduction of adverse events, improvement in efficacy and the ability to reach
the tumor more quickly.
Our
anticipated mechanism of action for INNO-206 is as follows:
·
|
after
administration, INNO-206 rapidly binds endogenous circulating albumin
through the EMCH linker;
|
·
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circulating
albumin preferentially accumulates in tumors, bypassing uptake by other
non-specific sites, including the heart, bone marrow and the
gastrointestinal tract;
|
·
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once
albumin-bound INNO-206 reaches the tumor, the acidic environment of the
tumor causes cleavage of the acid sensitive linker;
and
|
·
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free
doxorubicin is released at the site of the
tumor.
|
Pre-clinical
data. In a variety of preclinical models, INNO-206 was
superior to doxorubicin in its ability to increase dosing, antitumor efficacy,
and safety, including a reduction in cardiotoxicity.
Clinical data. A
Phase I study of INNO-206 that demonstrated safety and objective clinical
responses in a variety of tumor types was completed in 2005 and presented at the
March 2006 Krebskongress meeting in Berlin. In this study, single doses were
administered at up to six times the standard dosing of doxorubicin without an
increase in observed side effects over historically observed levels with
doxorubicin. Twenty-four of 35 evaluable patients had either a clinical response
or stable disease. Objective
clinical responses were observed in patients with sarcoma, breast, and lung
cancers.
Development
Plan. Based on the objective clinical responses seen in the
Phase I study, we intend to initially develop INNO-206 as a therapeutic for
patients with solid tumors, such as SCLC patients who have relapsed after
initial chemotherapy. This indication has a very poor prognosis with the current
standard of care, topotecan, which is used in approximately 30% of SCLC patients. Based on the
existing preclinical and clinical data for INNO-206, we believe there is the
potential to demonstrate superiority to topotecan in the second-line SCLC
setting.
Beyond
this initial indication, we will explore the utility of INNO-206 in chemotherapy
regimens that currently include doxorubicin, both for solid tumors and other
indications. If the Phase I data were to hold up in larger randomized studies,
we believe the potential exists for INNO-206 to replace doxorubicin based on
higher efficacy and improved side effect profile, although this has not been
proven.
Bafetinib. Bafetinib
(formerly INNO-406) is a novel drug developed by the Japanese pharmaceutical
company Nippon Shinyaku, to overcome the limitations of Gleevec and second-line
tyrosine kinase inhibitors in resistant chronic myelogenous leukemia, or CML. At
present, there are no approved third-line treatments for refractory
CML.
Bafetinib for the Treatment of
CML. CML is a type of blood cancer that occurs in
approximately 4,570 patients per year in the
U.S. Approximately 95% of CMLs contain a genetic translocation known
as Bcr-Abl, which signals the cells to proliferate. Bcr-Abl does not exist in
normal cells.
In 2001,
Novartis AG won approval in the U.S. for its drug, Gleevec. Gleevec
is a chemical molecule specifically designed to stop Bcr-Abl from emitting its
signals for cell growth. Gleevec proved effective in treating
patients with CML by inhibiting Bcr-Abl. Patients remain on Gleevec
as chronic therapy. The reported five-year survival rate for patients
with CML has gone from approximately 35% before the approval of Gleevec in 2001
to approximately 90% in 2006. Worldwide sales of Gleevec in 2006 were
$2.5 billion.
6
Unfortunately,
resistance to Gleevec has begun to occur. Resistance to Gleevec
appears to occur due to amplification of the Bcr-Abl gene and, in many cases,
mutations in the Bcr-Abl gene. In other cases, some of the genes that
Bcr-Abl signals to turn on are becoming turned on independently of Bcr-Abl,
making inhibition of the gene by Gleevec ineffective. Lyn is a member
of the Src family of kinases. These kinases are known to be involved
in sending out signals that drive cell growth. Lyn has been shown to be one
of the genes that is turned on by Bcr-Abl, and Lyn is known to be active in some
Gleevec-resistant CMLs. Activation of Lyn is therefore suspected of
being another mechanism by which cells become resistant to Gleevec.
The
development of resistance to Gleevec means that a second generation of drugs is
required to treat CML. Ideally, these new drugs would be able to
inhibit Bcr-Abl, even in its mutated form, and also independently turn off other genes
that Bcr-Abl normally activates.
Dasatinib,
from Bristol-Myers Squibb, is the leading second-generation Bcr-Abl
inhibitor. Dasatinib gained conditional U.S. marketing approval in
June 2006. Dasatinib has high potency in inhibiting Bcr-Abl and also
inhibits Src, a family of kinases known to be involved in cell
growth. In clinical studies, Dasatinib has shown good activity in
Gleevec-resistant patients. However, there have also been concomitant
side effects, including serious and life-threatening pleural effusion. In fact,
it is estimated that two-thirds of patients experience dose reductions or
interruptions, and in data provided by Bristol-Myers Squibb 20% to 30% of
patients that initiate dasatinib therapy discontinue its use due to
intolerance. This side effect profile is believed to be due to
non-specific kinase inhibition, but that has not yet been proven. It
is not clear whether a Bcr-Abl and Lyn inhibitor would have similar side
effects.
Nilotinib,
another second generation Bcr-Abl inhibitor being developed by Novartis AG,
received accelerated approval in the U.S. Nilotinib has potent activity against
Bcr-Abl. In its Phase I clinical trial, Nilotinib showed good
activity in Gleevec-resistant patients. In Phase II clinical data
presented at the American Society for Hematology conference in 2006, Nilotinib
showed efficacy similar to dasatinib in Gleevec-resistant patients.
Bafetinib
is roughly 25 to 55 times more potent at inhibiting Bcr-Abl than Gleevec in cell
culture. Bafetinib is also capable of inhibiting 19 of the 20 tested
mutated forms of
Bcr-Abl in CML that are resistant to Gleevec. In addition, bafetinib is capable
of shutting down the activity of the Lyn protein. This ability to
inhibit the activity of Lyn is independent of bafetinib’s ability to inhibit
Bcr-Abl.
We
believe that these properties of bafetinib, including its higher potency than
Gleevec, the ability to inhibit the mutated forms of Bcr-Abl and the addition of
Lyn inhibition, might make it an effective treatment for CML, although we are in
the early stages of the clinical testing only and none of bafetinib’s potential
advantages have been clinically proven.
Pre-clinical
Data. In mice-leukemia models, bafetinib has been shown to
markedly extend the survival of animals implanted with Gleevec-resistant
leukemic cells. In toxicology studies done in mice, rats, and dogs, bafetinib
appeared to be safe and well-tolerated. A dose was described in dogs
in which no side effects were seen was used to calculate the starting dose in
humans for our recently completed clinical trial.
Phase I Study. In
November 2008, we announced that bafetinib demonstrated clinical responses in
patients with CML in a Phase I clinical trial conducted in patients with CML and
other leukemias that have a certain mutation called the Philadelphia Chromosome
(Ph+) and are intolerant of or resistant to Gleevec and, in some cases,
second-line tyrosine kinase inhibitors such as dasatinib (Sprycelâ)
and nilotinib (Tasignaâ)).
The clinical trial was designed to identify the optimal dose for possible future
studies by escalating doses from 30 mg once per day to up to 480 mg twice per
day in a total of 56 patients with Ph+ leukemias. Of the patients, 31 had CML in
chronic phase (CML-CP), nine were in accelerated phase (CML-AP), seven were in
blast phase (CML-BP), and nine had Ph+ acute lymphocytic leukemia. The clinical
trial was conducted at seven clinical sites in the US, Germany, and Israel, with
Hagop Kantarjian, M.D., Professor & Chairman, Department of Leukemia, The
University of Texas, M.D. Anderson Cancer Center, serving as the Principal
Investigator. A positive, dramatic decrease in the number of leukemia
cells in the bone marrow was seen in 35% of the patients that were randomly
chosen to begin their treatment with the optimal INNO-406 dose of 240 mg
twice per day.
The
maximum tolerated
dose was determined to be 240 mg given twice per day, based on evidence of
increasing potential liver toxicity at higher doses. Common adverse events
(observed in greater than 20% of patients in the 240 mg twice per day dose
group) were gastrointestinal related, swelling, and fatigue. There was no
evidence of fluid accumulating around the lungs, or significant changes in a
certain heart rhythm called QTc prolongation, which are serious side effects
known to occur in patients treated with approved drugs for this indication.
Approximately 13% of patients across all dose groups discontinued dosing due to
unacceptable toxicity.
7
In 2007,
the FDA granted Orphan Drug Designation to bafetinib for the
treatment of Gleevec-resistant or intolerant CML. Based on the
results of our Phase I study, we intend to seek a strategic partner for the
further development of bafetinib.
Arimoclomol. Arimoclomol is
an orally-administered small-molecule product candidate that we believe
functions by stimulating a normal cellular protein repair pathway by amplifying
activated molecular chaperone proteins implicated in neurological
disorders.
Arimoclomol for the treatment of
ALS. ALS, or Lou Gehrig’s disease, is a debilitating and ultimately
deadly disease involving the progressive degeneration of motor neurons believed
to be caused by toxic mis-folding of proteins. According to the ALS Association,
approximately 30,000 people in the U.S. are living with ALS and 5,600 new cases
are diagnosed each year. Worldwide, an estimated 120,000 people are living with
ALS. According to the ALS Survival Guide, 50% of ALS patients die within 18
months of diagnosis and 80% die within five years of diagnosis.
The
following is a summary of our clinical development of arimoclomol for treating
ALS:
·
|
in
July 2006, we completed an 84-patient, multi-center, double-blind,
placebo-controlled, multi-dose Phase IIa clinical trial of safety and
tolerability of arimoclomol in volunteers with ALS, which we refer to as
the Phase IIa trial;
|
·
|
in
May 2007, we completed an open-label extension of the Phase IIa trial in
approximately 70 ALS patients from the trial who were administered the
highest investigational dose (100 mg three times daily) of arimoclomol for
an additional six months;
|
·
|
in
June 2007, we completed a multiple ascending-dose clinical trial of safety
and tolerability involving 40 healthy
volunteers;
|
·
|
in
November 2007, we completed a 28-day safety clinical trial with 400 mg of
arimoclomol three times daily involving 16 healthy volunteers;
and
|
·
|
in
December 2007, we initiated patient screening in a double blind,
placebo-controlled Phase IIb clinical study. In this trial, we expect to
enroll 390 ALS patients at 30 to 40 clinical sites in the U.S. and Canada.
The primary purpose of this trial is to evaluate the safety and efficacy
of a 400 mg dose of arimoclomol administered orally three times daily. The
Phase IIb clinical trial was placed on clinical hold by the FDA in January
2008. Based on written correspondence we received from the FDA, their
decision pertained to a previously completed animal toxicology study in
rats and was not related to data generated from any human studies with
arimoclomol. We are in the process of completing additional
animal toxicology studies that we plan to submit to the FDA in the second
quarter of 2009.
|
Phase IIa clinical trial.
Participants in the Phase IIa clinical trial of arimoclomol were administered
either a placebo capsule, or one of three dosage levels of arimoclomol capsules,
three times daily for a period of 12 weeks, immediately followed by a one-month
period without the drug. The primary endpoints of the Phase IIa trial were
safety and tolerability. Secondary endpoints included a preliminary evaluation
of efficacy using two widely accepted disease-progression markers. The first
marker, the revised ALS Functional Rating Scale, or ALSFRS-R, is used to
determine patients’ overall functional capacity and independence in 13
activities. The second marker measures vital capacity, an assessment of lung
capacity, which is an important disease indicator since ALS sufferers eventually
lose the ability to breathe on their own. The trial was designed to be able to
detect only extreme responses in these two markers.
The
results from our Phase IIa trial and open-label extension clinical trial
indicated that arimoclomol was safe and well tolerated in ALS volunteers, even
at the highest administered dose. Arimoclomol was detected in participants’
cerebral spinal fluid, demonstrating that it passed the so-called blood:brain
barrier, and participants treated with arimoclomol experienced a statistically
significant decrease in adverse events of weakness compared with the placebo
group. As would be expected based upon the small size and short duration of the
Phase IIa trial, we observed no statistically significant effects in disease
progression markers. We did, however, observe a trend toward slower disease
progression in the highest dosage group. Since there was no concurrent placebo
control group in our open-label extension clinical trial, we compared the
results with results in an untreated placebo group with similar characteristics
in a prior ALS clinical trial published in July 2006 in Annals of Neurology. The results
indicated a trend toward a slower average progression in every disease marker in
the patients treated with arimoclomol compared to the historical placebo
control. In particular, we observed a decrease of 21% in the rate of decline for
ALSFRS-R, 8% for vital capacity, 23% for total body weight and 20% for body mass
index when compared with that historical control. No definitive conclusions can
be drawn from these
8
data without a concurrent placebo control group, and investors are
cautioned against relying on these data as an indication of arimoclomol’s
potential efficacy.
The
favorable safety and tolerability profile observed in our Phase IIa trial,
open-label extension clinical trial and animal toxicology studies of arimoclomol
suggested that we may be able to safely increase the dose of arimoclomol without
causing significant side effects. The results from the subsequent multiple
ascending-dose study indicated that arimoclomol was safe and well tolerated,
even at doses of 600 mg three times daily (six times higher than the highest
dose used in the Phase IIa and open-label studies), when administered to healthy
volunteers over a seven-day period. Results from the 28-day safety clinical
trial in healthy volunteers indicated that the dosage of 400 mg administered
three times daily also was safe and well tolerated.
Phase IIb efficacy trial. In
January 2008, the FDA placed on clinical hold our planned efficacy trial to
evaluate the safety and efficacy in ALS patients of a 400 mg dose of arimoclomol
administered orally three times daily. Based on written correspondence we
received from the FDA, their decision pertained to a previously completed animal
toxicology study in rats and was not related to data generated from any human
studies with arimoclomol. We are completing further animal toxicology studies of
arimoclomol, and plan to submit data from those studies to the FDA in the second
quarter of 2009. Subject to the results of these studies and our ability to
provide satisfactory information to the FDA to remove the clinical hold, we plan
to seek a strategic partner for the further development of arimoclomol for all
indications.
Other Clinical
Development. In February 2009, a Phase II/III adaptive
clinical trial commenced to study arimoclomol in a subset of patients with the
inherited or familial form ALS. Patients with familial ALS (fALS) who harbor
certain mutations in the superoxide dismutase-1 (SOD1) gene suffer from a
rapidly progressing form of the disease. The clinical trial is being financially
supported by grants from the ALS Association and the U.S. Food and Drug
Administration’s (FDA’s) Office of Orphan Products Development (OOPD), and we
are supplying the drug and allowing the sponsor to reference our Investigational
New Drug Application for regulatory purposes.
Arimoclomol for recovery from
stroke. Stroke results from an acute loss of normal blood flow to the
brain caused most often by a blockage in a blood vessel (ischemic) or due to
leaking of blood from a vessel (hemorrhagic). According to the American Heart
Association: stroke is the
third leading cause of death and the number one cause of long-term
disability in the U.S.; between 50% and 70% of stroke survivors regain
functional independence, but between 15% and 30% are permanently disabled and
20% require institutional care within three months after stroke; and the direct
and indirect stroke cost in the U.S. totaled approximately $58 billion in
2006.
After the
normal flow of blood is restored to the brain after the initial event,
post-stroke neurological function continues to decline. We believe that this
continuing decline in neurological function is the consequence of mis-folded
protein aggregates generated as a result of oxygen deprivation during the
original event.
Preclinical
efficacy studies completed by us in April 2007 indicated that arimoclomol
accelerated the time to recovery, and improved recovery, in experimental animal
models of stroke. These results were obtained even when arimoclomol was
administered as long as 48 hours after onset.
By
comparison, tissue plasminogen activator, or t-PA, the only treatment currently
approved in the U.S. for acute ischemic stroke, must be administered within
three hours of stroke, which substantially limits the number of patients who
qualify for this treatment.
In light
of these preclinical data, we plan to seek a partner for the development of
arimoclomol for stroke recovery and other indications.
Iroxanadine. Iroxanadine also
is an orally-administered small-molecule product candidate. We believe it
functions by stimulating the molecular chaperone protein response in the
endothelium, the thin layer of cells that line the interior surface of human
blood vessels.
Iroxanadine for the treatment of
diabetic ulcers. Type 2 diabetes is a major health problem with
significant secondary complications. The American Diabetes Association estimates
that there are 21 million type 2 diabetes sufferers in the U.S. The World Health
Organization estimates that there are more than 162 million cases of type 2
diabetes worldwide. According to the American Diabetes Association, 15% of all
diabetics will develop a foot ulcer during their lifetime, and over 82,000
non-traumatic lower-limb amputations were performed on diabetics in the U.S. in
2002 due to such ulcers and other complications. We believe there is
strong
9
support in the scientific literature for the assertion that
diabetic foot ulcers fail to heal efficiently, in part, due to the dysfunction
of endothelial cells lining the blood vessels caused by protein
mis-folding.
Animal
studies completed by us in May 2007 indicated that iroxanadine significantly
decreased the time it took for wounds to heal in diabetic mice without affecting
healing in healthy mice. Wound healing in the diabetic mice, which normally
required twice the time to heal as healthy mice, was accelerated to the extent
that healing time of diabetic mice treated with iroxanadine was
indistinguishable from that in untreated healthy mice.
In Phase
I clinical trials in healthy volunteers and Phase II clinical trials in patients
with chronic high blood pressure conducted prior to our acquisition of
iroxanadine, iroxanadine was determined to be safe and well-tolerated and
demonstrated significant improvement in the function of endothelial cells in the
brachial artery, a major blood vessel of the upper arm.
Based on
our preclinical results and the earlier clinical study data, we plan to seek a
strategic partner for the further development of iroxanadine.
Our
New-Drug Discovery Research Programs and Other Technologies
We are
conducting research at our laboratory facility in San Diego, California, aimed
at discovering and validating novel drug targets utilizing our master chaperone
regulator assay, or MaCRA, drug discovery process. We have filed a
patent application on our MaCRA technology, and plan to file in the second
quarter of 2009 our first patent applications on new chemical entities discovered in the
laboratory. We intend to assess periodically the costs and potential commercial
value of our new-drug discovery activities. Depending on these
assessments, we may determine to modify, out-source, partner or suspend these
activities.
Our other
current technologies, which we developed prior to the acquisition of our
molecular chaperone amplification technology, are CRL-5861, an intravenous agent
for treatment of sickle cell disease and other acute vaso-occlusive disorders,
and TranzFect, a delivery technology for DNA-based and conventional vaccines and
other potential uses.
Our
Separation from RXi Pharmaceuticals Corporation
Until
early 2008, we owned approximately 85% of the outstanding shares of common stock
of RXi and our financial statements, including our financial statements as of
and for the year ended December 31, 2007, included the consolidated financial
condition and results of operations of RXi. On February 14, 2008, our board of
directors declared a dividend of one share of RXi common stock for each
approximately 20.05 outstanding shares of our common stock, which was paid on
March 11, 2008 and which reduced our ownership of RXi shares to less than
50%. As a result, our financial statements since March 11, 2008 no longer
consolidate the financial condition and results of operation of RXi, but instead
reflect our ongoing investment in RXi based on the equity method of accounting
as discussed in the “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” section of this Annual Report. At present, we own
approximately 45% of the outstanding shares of RXi common stock.
We are
party to a letter agreement with RXi and some of RXi’s current stockholders
under which we are entitled to preemptive rights to acquire any “new securities”
(as defined) that RXi proposes to sell or issue, so that we may maintain our
percentage ownership in RXi. Our preemptive rights will expire on January 8,
2012 or such earlier time at which we own less than 10% of RXi’s outstanding
common stock.
Under the
letter agreement with RXi, we agreed to vote our RXi shares for the election of
RXi directors and take other actions to ensure that a majority of the board of
directors of RXi are independent of us. We further agreed to approve of actions
that may be adopted and recommended by the RXi board of directors to facilitate
any future financing by RXi.
Manufacturing
We have
no capability to manufacture supplies of any of our products, and rely on
third-party manufacturers to produce materials needed for research and clinical
trials. We have contracted with various contract manufacturing
facilities for supply of our active pharmaceutical ingredient, or API, for our
product candidates. Pursuant to our license with TMRC Co., Ltd., or TMRC,
relating to tamibarotene, TMRC will provide us with tamibarotene at a fixed
price and in a quantity and quality sufficient to meet our clinical and
commercial needs.
10
To be
commercialized, our products also must be capable of being manufactured in
commercial quantities in compliance with stringent regulatory requirements and
at an acceptable cost. We intend to rely on third-party manufacturers to produce
commercial quantities of any products for which we are able to obtain marketing
approval. We have not commercialized any product, and so we also have not
demonstrated that any of our product candidates can be manufactured in
commercial quantities in accordance with regulatory requirements or at an
acceptable cost.
If our
product candidates cannot be manufactured in suitable quantities and in
accordance with regulatory standards, our clinical trials, regulatory approvals,
and marketing efforts for such products may be delayed. Such delays could
adversely affect our competitive position and our chances of generating
significant recurring revenues. If our products are not able to be manufactured
at an acceptable cost, the commercial success of our products may be adversely
affected.
Marketing
Our
tentative plan is to establish our own sales force and marketing capability in
order to commercialize tamiboratene and INNO-206 in the U.S. and to seek a
marketing partner for commercialization in other territories.
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 acquired patents and patent applications, and
have filed several new patent applications, in connection with our molecular
chaperone program.
We
regularly evaluate the patentability of new inventions and improvements
developed by us or our collaborators, and, whenever appropriate, will endeavor
to file U.S. and international patent applications to protect these new
inventions and improvements. We cannot be 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 U.S. or any
other country. There also is no assurance that any issued patents will be
effective to prevent others from using our products or processes. It is also
possible that any patents issued to us, 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 molecular chaperone
amplification and other small molecule technology or other compounds, products
or processes that may be competitive with ours.
In
addition to patent protection, we 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, but there is no
assurance that these agreements will afford significant protection against
misappropriation or unauthorized disclosure of our trade secrets and
confidential information.
LICENSE
AGREEMENTS
Tamibarotene
We have
succeeded to Innovive’s agreement with TMRC for the license of patent rights
held by TMRC for the North American development and commercialization of
tamibarotene. The license is exclusive, applies to all products that may be
subject to the licensed intellectual property and may be used in the treatment
of APL. We may sublicense the intellectual property in our sole discretion. The
agreement also grants us an option to include within the license the use of the
drug in other fields in oncology including multiple myeloma, myelodysplastic
syndrome, and solid tumors.
Under the
agreement, we must pay TMRC royalties based on net sales and make payments to
TMRC in the aggregate of $4.165 million upon meeting clinical, regulatory, and
sales milestones up to and including the first commercial sale of the product
for the treatment of APL.
Under the
agreement, we must use commercially reasonable efforts to conduct the research
and development activities we determine are necessary to obtain regulatory
approval to market the product in those countries in North America that we
determine are commercially feasible.
11
The
agreement will expire upon the expiration of the subject patent rights, or 15
years from the date of first commercial sale of product in North America,
whichever is later. The agreement may be terminated if either party is in breach
and the breach is not cured within a required amount of time. We may also
terminate the agreement in the event of a material change in the safety profile
of the technology that makes continued development impossible.
INNO-206
We also
have succeeded to Innovive’s agreement with KTB Tumorforschungs GmbH, or KTB,
for the license of patent rights held by KTB for the worldwide development and
commercialization of INNO-206. The license is exclusive and
worldwide, applies to all product that may be subject to the licensed
intellectual property and may be used in all fields of use. We may sublicense
the intellectual property in our sole discretion. The agreement also grants us
an option to include within the license any technology that is claimed or
disclosed in the licensed patents and patent applications for use in the field
of oncology and the right of first refusal on any license that KTB wishes to
make to a third party regarding any technology that is claimed or disclosed in
the licensed patents and patent applications for use in the field of
oncology.
Under the
agreement, we must make payments to KTB in the aggregate of $7.5 million upon
meeting clinical and regulatory milestones up to and including the product’s
second final marketing approval. We also agreed to pay:
·
|
commercially
reasonable royalties based on a percentage of net sales (as defined in the
agreement);
|
·
|
a
percentage of non-royalty sub-licensing income (as defined in the
agreement); and
|
·
|
milestones
of $1 million for each additional final marketing approval that we might
obtain.
|
In the
event that we must pay a third party in order to exercise our rights to the
intellectual property under the agreement, we will deduct a percentage of those
payments from the royalties due KTB, up to an agreed upon cap. This deduction
includes a percentage of any payments that might be required to be made by us to
Bristol-Myers Squibb. Bristol-Myers Squibb holds a patent on technology that
might be considered to block the patents and patent applications that are the
subject of the agreement with KTB.
Under the
agreement with KTB, we must use commercially reasonable efforts to conduct the
research and development activities we determine are necessary to obtain
regulatory approval to market the product in those countries that we determine
are commercially feasible. Under the agreement, KTB is to use its commercially
reasonable efforts to provide us with access to suppliers of the API of the
product on the same terms and conditions as may be provided to KTB by those
suppliers.
The
agreement will expire on a product-by-product basis upon the expiration of the
subject patent rights. We have the right to terminate the agreement on 30 days
notice, provided we pay a cash penalty to KTB. KTB may terminate the agreement
if we are in breach and the breach is not cured within a specified cure period
or if we fail to use diligent and commercial efforts to meet specified clinical
milestones.
Bafetinib
We
likewise have succeeded to Innovive’s exclusive, worldwide (with the exception
of Japan) royalty-bearing license agreement with Nippon Shinyaku, including the
right to grant sublicenses, for the intellectual property relating to bafetinib
in all fields. The license agreement will expire on a
country-by-country basis upon the expiration of the subject patent rights. The
bafetinib license covers two Patent Cooperation Treaty, or PTC, applications
filed in 2003 and 2004, respectively.
Under the
agreement, we are obliged to pay Nippon Shinyaku an aggregate of $13.35 million
(including $5 million upon the product’s initial final marketing approval) upon
the achievement of clinical and regulatory milestones up to and including
approvals in the U.S. and Europe. We also will be obliged to pay:
·
|
commercially
reasonable royalties based on a percentage of net sales (as defined in the
Nippon Shinyaku license agreement), dependent on reaching certain revenue
thresholds;
|
·
|
annual
minimum payments if sales of bafetinib do not meet specified levels;
and
|
12
·
|
a
percentage of non-royalty sub-licensing income (as defined in the license
agreement).
|
The
agreement includes covenants that require us to, among other things, file an NDA
by a specific date and use our commercially reasonable efforts to bring a
licensed product to market. In the event that we breach a material
term of the Nippon Shinyaku license agreement, Nippon Shinyaku has the option to
terminate the agreement following the giving of notice and an opportunity to
cure any such breach.
Under the
merger agreement by which we acquired Innovive, we agreed to pay the former
Innovive stockholders up to $1.01 per Innovive share of future earnout merger
consideration, subject to our achievement of specified net sales under the
Innovive license agreements. The earnout merger consideration, if
any, will be payable in shares of our common stock, subject to specified
conditions, or, at our election, in cash or by a combination of shares of our
common stock and cash. Our common stock will be valued for purposes
of any future earnout merger consideration based upon the trading price of our
common stock at the time the earnout merger consideration is paid.
Competition
To our
knowledge, there are no competitors in clinical development for refractory
APL. Currently, treatment of APL is based on induction and
maintenance therapy with ATRA and chemotherapy (typically
idarubicin). ATRA and idarubicin are both generic
compounds. Arsenic trioxide, currently marketed by Cephalon, is
approved for use in patients who have relapsed after ATRA-based therapy in
APL. There are no FDA-approved therapies for patients who have failed
arsenic trioxide. In practice, it appears that patients who fail
arsenic trioxide are retreated with ATRA or receive Mylotarg, which is marketed
by Wyeth Pharmaceuticals.
We are
aware of two compounds in late-stage testing for SCLC. The first
compound is picoplatin from Poniard Pharmaceuticals. Picoplatin is a
platinum agent that is currently in a Phase III study in SCLC. The
Phase III study looks to compare picoplatin in combination with best supportive
care alone in patients who were refractory to platinum therapy or failed to
respond to platinum therapy within six months. We will test INNO-206
in patients who initially had a response on platinum therapy.
The
second compound in development in SCLC is amrubicin from
Celgene. Amrubicin is a synthetic anthracycline currently approved in
Japan for use in lung cancer. Celgene commenced a Phase III study in
the second half of 2007 in relapsed and refractory SCLC patients based on Phase
II data from Japan showing a survival of between 9.2 months and 11.7 months in
this population.
Amrubicin
and doxorubicin are both anthracyclines. We believe that the
albumin-binding ability of INNO-206 will allow the compound to overcome many of
the side effect issues typically associated with anthracyclines. We
also believe that using albumin as a carrier will allow for higher dosing and
greater efficacy.
There are
currently two main competitors to INNO-406 in the Gleevec-resistant CML market,
Dasatanib and nilotinib. Although both of these drugs are ahead of us
in clinical testing and commercialization, we believe the head-start in
development will not prove critical in the commercial setting, because CML is
becoming a chronic condition much like HIV or depression and the market for
treatment is large enough to accommodate several drugs.
Dasatinib
from Bristol-Myers Squibb, was the first of the second-generation Bcr-Abl
inhibitors to gain U.S. marketing approval from the
FDA. Bristol-Myers Squibb began distributing the product in July
2006. Dasatinib has high potency in inhibiting Bcr-Abl and also
inhibits Src, a family of kinases known to be involved in cell
growth. In clinical studies, dasatinib has shown good activity in
Gleevec-resistant patients. However, there have also been concomitant
side effects, including serious and life threatening pleural
effusion. In various studies presented to date, roughly 20% to 30% of
the patients that start therapy are discontinuing. We believe a
significant number of these patients are discontinuing due to the side effect
profile of the drug. This side effect profile may be related to Src
inhibition, but that has not yet been proven.
Nilotinib
from Novartis AG, has completed its Phase II clinical study and was granted
accelerated marketing approval by the FDA in October 2007 for the treatment of
chronic phase and accelerated phase Philadelphia chromosome positive (Ph+) CML
in adult patients resistant or intolerant to prior treatment with
Gleevec. Nilotinib has potent activity against Bcr-Abl. In its
Phase I clinical trial, Nilotinib showed good activity in Gleevec-resistant
patients. In Phase II clinical data presented at the American Society for
Hematology conference in 2006, nilotinib showed efficacy similar to dasatinib in
Gleevec-resistant patients.
13
Other
clinical compounds in development for CML include:
·
|
Wyeth’s
SKI-606 is a dual Abl and Src kinase inhibitor similar to dasatinib and is
currently in a Phase III trial in newly diagnosed Ph+ CML
patients;
|
·
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Ceflatonin
from Chemgenix, a plant alkaloid primarily targeting a single Bcr-Abl
mutation known as T315I, which is in a Phase II/III clinical
trial;
|
·
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Exelixis’
XL228,a multi-kinase inhibitor that targets Src and Abl , has shown
preclinical activity against the T315I mutation and is in a Phase I
clinical trial in CML patients; and
|
·
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AP24534
from Ariad Pharmaceuticals is a multi-kinase inhibitor that targets
Bcr-Abl including the T315I mutation and is in a Phase I clinical trial in
CML patients.
|
We are
aware of only one drug, rilutek, developed by Aventis Pharma AG, that has been
approved by the FDA for the treatment of ALS. Many companies are working to
develop pharmaceuticals to treat ALS, including Aeolus Pharmaceuticals,
Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceuticals, Trophos SA, Knopp
Neurosciences Inc., Faust Pharmaceuticals SA, Oxford BioMedica plc, Phytopharm
plc and Teva Pharmaceutical Industries Ltd., as well as RXi. ALS patients often
take over-the-counter supplements, including vitamin E, creatine and coenzyme
Q10, or drugs such as lithium that are approved for other indications. ALS
belongs to a family of neurodegenerative diseases that includes Alzheimer’s,
Parkinson’s and Huntington’s diseases. Due to similarities between these
diseases, a new treatment for one such disease potentially could be useful for
treating others. There are many companies producing and developing drugs used to
treat neurodegenerative diseases other than ALS, including Amgen, Inc., Biogen
Idec, Boehringer Ingelheim, Cephalon, Inc., Ceregene, Inc., Elan
Pharmaceuticals, plc, Forest Laboratories, Inc., H. Lundbeck A/S, Phytopharm
plc, UCB Group and Wyeth.
Current
drug classes used to treat stroke include antiplatelet agents, anticoagulants,
salycylates, neuroprotectants and thrombolytic agents. Prescription antiplatelet
agents include Aggrenox by Boehringer Ingelheim, Plavix by Sanofi-Aventis and
Bristol-Myers Squibb, and Ticlid by Roche Pharmaceuticals. Coumadin by
Bristol-Myers Squibb and Jantoven by Upsher-Smith Laboratories are branded forms
of warfarin, an anticoagulant. Moreover, Salicylates, like aspirin, are commonly
used to treat patients after stroke. In Europe, Ferrer Grupo markets the
neroprotectant, Somazina. Activase, also known as tissue plasminogen activator,
or t-PA, is a thrombolytic agent marketed by Genentech. Many new drug candidates
are in development by pharmaceutical and biotech companies, including
GlaxoSmithKline, Ipsen, Merck & Co., Ono Pharmaceuticals, PAION AG and
Wyeth. In addition to drug therapy, companies such as Medtronic and Northstar
Neurosciences are developing neurostimulation medical devices to aid in recovery
after stroke.
Many
companies, including large pharmaceutical and biotechnology firms with financial
resources, research and development staffs, and facilities that may 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
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 U.S.
and other developed countries extensively regulate the preclinical and clinical
testing, manufacturing, labeling, storage, record-keeping, advertising,
promotion, export, marketing and distribution of drugs and biologic products.
The FDA, under the Federal Food, Drug, and Cosmetic Act, the Public Health
Service Act and other federal statutes and regulations, regulates pharmaceutical
and biologic products.
14
To obtain
approval of our product candidates from the FDA, we must, among other
requirements, submit data supporting safety and efficacy for the intended
indication as well as detailed information on the manufacture and composition of
the product candidate. In most cases, this will require extensive laboratory
tests and preclinical and clinical trials. The collection of these data, as well
as the preparation of applications for review by the FDA involve significant
time and expense. The FDA also may require post-marketing testing to monitor the
safety and efficacy of approved products or place conditions on any approvals
that could restrict the therapeutic claims and commercial applications of these
products. Regulatory authorities may withdraw product approvals if we fail to
comply with regulatory standards or if we encounter problems at any time
following initial marketing of our products.
The first
stage of the FDA approval process for a new biologic or drug involves completion
of preclinical studies and the submission of the results of these studies to the
FDA. These data, together with proposed clinical protocols, manufacturing
information, analytical data and other information submitted to the FDA, in an
investigational new drug application, or IND, must become effective before human
clinical trials may commence. Preclinical studies generally involve FDA
regulated laboratory evaluation of product characteristics and animal studies to
assess the efficacy and safety of the product candidate.
After the
IND becomes effective, a company may commence human clinical trials. These are
typically conducted in three sequential phases, but the phases may overlap.
Phase I trials consist of testing of the product candidate in a small number of
patients or healthy volunteers, primarily for safety at one or more doses. Phase
II trials, in addition to safety, evaluate the efficacy of the product candidate
in a patient population somewhat larger than Phase I trials. Phase III trials
typically involve additional testing for safety and clinical efficacy in an
expanded population at multiple test sites. A company must submit to the FDA a
clinical protocol, accompanied by the approval of the Institutional Review
Boards at the institutions participating in the trials, prior to commencement of
each clinical trial.
To obtain
FDA marketing authorization, a company must submit to the FDA the results of the
preclinical and clinical testing, together with, among other things, detailed
information on the manufacture and composition of the product candidate, in the
form of a new drug application, or NDA.
The
amount of time taken by the FDA for approval of an NDA will depend upon a number
of factors, including whether the product candidate has received priority
review, the quality of the submission and studies presented, the potential
contribution that the compound will make in improving the treatment of the
disease in question, and the workload at the FDA.
The FDA
may, in some cases, confer upon an investigational product the status of a fast
track product. A fast track product is defined as a new drug or biologic
intended for the treatment of a serious or life-threatening condition that
demonstrates the potential to address unmet medical needs for this condition.
The FDA can base approval of an NDA for a fast track product on an effect on a
surrogate endpoint, or on another endpoint that is reasonably likely to predict
clinical benefit. If a preliminary review of clinical data suggests that a fast
track product may be effective, the FDA may initiate review of entire sections
of a marketing application for a fast track product before the sponsor completes
the application. The FDA has granted fast track designation and orphan drug
status to arimoclomol for the treatment of ALS.
We
anticipate that our products will be manufactured by our strategic partners,
licensees or other third parties. Before approving an NDA, the FDA will inspect
the facilities at which the product is manufactured and will not approve the
product unless the manufacturing facilities are in compliance with the FDA’s
cGMP, which are regulations that govern the manufacture, holding and
distribution of a product. 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. Following approval, the FDA
periodically inspects drug and biologic manufacturing facilities to ensure
continued compliance with the good manufacturing practices regulations. Our
manufacturers will have to continue to comply with those requirements. Failure
to comply with these requirements subjects the manufacturer to possible legal or
regulatory action, such as suspension of manufacturing or recall or seizure of
product. Adverse patient experiences with the product must be reported to the
FDA and could result in the imposition of marketing restrictions through
labeling changes or market removal. Product approvals may be withdrawn if
compliance with regulatory requirements is not maintained or if problems
concerning safety or efficacy of the product occur following
approval.
The
labeling, advertising, promotion, marketing and distribution of a drug or
biologic product also must be in compliance with FDA and Federal Trade
Commission requirements which include, among others, standards and regulations
for off-label promotion, industry sponsored scientific and educational
activities, promotional activities involving the internet, and
direct-to-consumer advertising. We also will be subject to a variety of federal,
state and local regulations relating to the use, handling, storage and disposal
of hazardous materials, including chemicals and radioactive and biological
materials. In addition, we will be subject to
15
various
laws and regulations governing laboratory practices and the experimental use of
animals. In each of these areas, as above, the FDA has broad regulatory and
enforcement powers, including the ability to levy fines and civil penalties,
suspend or delay issuance of product approvals, seize or recall products, and
deny or withdraw approvals.
We will
also be subject to a variety of regulations governing clinical trials and sales
of our products outside the U.S. Whether or not FDA approval has been obtained,
approval of a product candidate by the comparable regulatory authorities of
foreign countries and regions must be obtained prior to the commencement of
marketing the product in those countries. The approval process varies from one
regulatory authority to another and the time may be longer or shorter than that
required for FDA approval. In the European Union, Canada and Australia,
regulatory requirements and approval processes are similar, in principle, to
those in the U.S.
Employees
As of
March 11, 2009, we have 35 employees, four of whom are part-time
employees. As of that date, 26 of those employees were engaged in
research and development activities and nine were involved in management and
administrative operations.
Available
Information
We
maintain a website at www.cytrx.com and make available there, free of charge,
our periodic reports filed with the Securities and Exchange Commission, or SEC,
as soon as is reasonably practicable after filing. The public may read and copy
any materials we file with the SEC at the SEC’s Public Reference Room at 100 F
Street, NE, Washington, DC 20549. The public may obtain information on the
operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The
SEC maintains a website at http:/www.sec.gov that contains reports, proxy and
information statements, and other information regarding issuers such as us that
file electronically with the SEC. We post on our website our Code of Business
Conduct and Ethics.
Item
1A. RISK FACTORS
We
are subject to a number of risks and uncertainties, including the risks and
uncertainties discussed below, as well as any modification, replacement or
update to these risks and uncertainties that are reflected in any subsequent
filings we make with the Securities and Exchange Commission, or SEC. If any of
these risks or uncertainties actually occur, our business, results of
operations, financial condition and prospects could be materially and adversely
affected. In that case, the trading price of our common stock could decline.
These risks and uncertainties are not the only ones facing us. Additional risks
and uncertainties not presently known to us, or that we currently perceive as
immaterial, also may adversely affect us.
Risks
Associated With Our Business
We
have operated at a loss and will likely continue to operate at a loss for the
foreseeable future.
We have
operated at a loss due to our ongoing expenditures for research and development
of our product candidates and for general and administrative purposes and lack
of significant recurring revenue. We incurred net losses of $27.0 million, $21.9
million and $16.8 million for the years ended December 31, 2008, 2007 and 2006,
respectively, and we had an accumulated deficit as of December 31, 2008 of
approximately $192.0 million. We are likely to continue to incur losses unless
and until we are able to commercialize one or more of our product candidates.
These losses, among other things, have had and will continue to have an adverse
effect on our stockholders’ equity and working capital. Because of the numerous
risks and uncertainties associated with our product development efforts, we are
unable to predict when we may become profitable, if at all. If we are unable to
achieve and then maintain profitability, the market value of our common stock
will likely decline.
Because
we have no source of significant recurring revenue, we must depend on financing
to sustain our operations.
Developing
products and conducting clinical trials require substantial amounts of capital.
To date, we have relied primarily upon proceeds from sales of our equity
securities and the exercise of options and warrants to generate funds needed to
finance our business and operations. We will need to raise additional capital
to, among other things:
·
|
fund
our clinical trials and pursue regulatory approval of our existing and
possible future product candidates;
|
·
|
expand
our research and development
activities;
|
16
·
|
finance
our general and administrative
expenses;
|
·
|
acquire
or license new technologies;
|
·
|
prepare,
file, prosecute, maintain, enforce and defend our patent and other
proprietary rights; and
|
·
|
develop
and implement sales, marketing and distribution capabilities to
successfully commercialize any product for which we obtain marketing
approval and choose to market
ourselves.
|
Our
revenues were $6.3 million, $7.5 million and $2.1 million, respectively, for
years ended December 31, 2008, 2007 and 2006, which included $6.2 million, $7.2
million and $1.8 million, respectively, of deferred revenue recognized from our
sale in August 2006 of a one-percent royalty interest in worldwide sales of
arimoclomol for the treatment of ALS. We will have no significant recurring
revenue unless we are able to commercialize one or more of our product
candidates in development, which may require us to first enter into license or
other strategic arrangements with third parties.
At
December 31, 2008, we had cash, cash equivalents and short-term investments of
$25.0 million. We believe that CytRx’s current resources will be sufficient to
support its currently planned level of operations through the first quarter of
2010. This estimate is based, in part, upon our currently projected expenditures
for 2009 of approximately $22 million, including approximately $7.1 million for
our clinical program for tamibarotene, approximately $3.4 million for our
clinical program for INNO-206, approximately $0.6 million for our clinical
program for INNO-406, approximately $0.5 million for our animal toxicology
studies and related activities for arimoclomol, approximately $1.8 million for
operating our clinical programs, approximately $2.7 million for research
activities at its laboratory in San Diego, California, and approximately $5.9
million for other general and administrative expenses. As
described in the risk factor that follows below in this section, these projected
expenditures are based upon numerous assumptions and subject to many
uncertainties, and our actual expenditures may be significantly different from
these projections.
If we
obtain marketing approval as currently planned and successfully commercialize
our product candidates, we anticipate it will take a minimum of three years, and
possibly longer, for us to generate significant recurring revenue, and we will
be dependent on future financing until such time, if ever, as we can generate
significant recurring revenue. Our ability to raise capital has been materially
and adversely affected by the downturn in the financial markets and poor
economy, which have severely depressed the market for private investment in
public equities, or PIPEs, transactions on which we have relied for raising
needed capital. These conditions also have materially and adversely affected the
market for our RXi shares. We have no commitments from third parties to provide
us with any additional financing, and we may not be able to obtain future
financing on favorable terms, or at all. Failure to obtain adequate financing
would adversely affect our ability to operate as a going concern. If we raise
additional funds by issuing equity securities, dilution to stockholders may
result and new investors could have rights superior to holders of the shares
issued in this offering. In addition, debt financing, if available, may include
restrictive covenants. If adequate funds are not available to us, we may have to
liquidate some or all of our assets or to delay or reduce the scope of or
eliminate some portion or all of our development programs or clinical trials. We
also may have to license to other companies our product candidates or
technologies that we would prefer to develop and commercialize
ourselves.
If
we do not achieve our projected development goals in the time frames we announce
and expect, or if our financial projections prove to be materially inaccurate,
the commercialization of our products may be delayed and our business prospects
may suffer.
From time
to time, we estimate the timing of the accomplishment of various scientific,
clinical, regulatory and other product development goals, which we sometimes
refer to as milestones. These milestones may include the commencement or
completion of scientific studies and clinical trials and the submission of
regulatory filings. For example, we have stated in this Annual Report the
expected timing of certain milestones relating to our tamibarotene, INNO-206 and
arimoclomol clinical development programs.
We also
may disclose projected expenditures or other forecasts for future periods such
as the statements above in this Annual Report regarding any current projected
expenditures for fiscal year 2009. These and other financial projections are
based on management’s current expectations and do not contain any margin of
error or cushion for any specific uncertainties, or for the uncertainties
inherent in all financial forecasting. The assumptions management has used to
produce these projections may significantly change or prove to be inaccurate.
Accordingly, you should not unduly rely on any of these
projections.
17
The
actual timing of milestones and actual expenditures or other financial results
can vary dramatically compared to our estimates, in some cases for reasons
beyond our control. If we do not meet milestones or financial projections as
announced from time to time, the development and commercialization of our
products may be delayed and our business prospects may suffer.
If
our products are not successfully developed and approved by the FDA, we may be
forced to reduce or curtail our operations.
All of
our product candidates in development must be approved by the FDA or similar
foreign governmental agencies before they can be marketed. The process for
obtaining FDA and foreign government approvals 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, including
post-approval testing, which may take longer or cost more than we or our
licensees, if any, 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 product candidates
may not necessarily be predictive of 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 product development
efforts, including the following:
·
|
difficulty
in securing centers to conduct
trials;
|
·
|
difficulty
in enrolling patients in conformity with required protocols or projected
timelines;
|
·
|
unexpected
adverse reactions by patients in
trials;
|
·
|
difficulty
in obtaining clinical supplies of the
product;
|
·
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changes
in or our inability to comply with FDA or foreign governmental product
testing, manufacturing or marketing
requirements;
|
·
|
regulatory
inspections of clinical trials or manufacturing facilities, which may,
among other things, require us or our manufacturers or licensees to
undertake corrective action or suspend or terminate the affected clinical
trials if investigators find them not to be in compliance with applicable
regulatory requirements;
|
·
|
inability
to generate statistically significant data confirming the safety and
efficacy of the product being
tested;
|
·
|
modification
of the product during testing; and
|
·
|
reallocation
of our limited financial and other resources to other clinical
programs.
|
In
addition, the FDA and other regulatory agencies may lack experience in
evaluating our product candidates. For example, we are aware of only one drug
that the FDA has approved to treat ALS. This inexperience may lengthen the
regulatory review process, increase our development costs and delay or prevent
commercialization of arimoclomol or our other product candidates. It is possible
that none of the product candidates we develop will obtain the regulatory
approvals necessary for us to begin selling them. The time required to obtain
FDA and foreign governmental approvals is unpredictable, but often can take
years following the commencement of clinical trials, depending upon the
complexity of the product candidate. Any analysis we perform on data from
clinical activities is subject to confirmation and interpretation by regulatory
authorities, which could delay, limit or prevent regulatory approval.
Furthermore, even if we obtain regulatory approvals, our products and the
manufacturing facilities used to produce them will be subject to continual
review, including periodic inspections and mandatory post- approval clinical
trials by the FDA and other US and foreign regulatory authorities. Any delay or
failure in obtaining required approvals or to comply with post-approval
regulatory requirements could have a material adverse effect on our ability to
generate revenue from the particular product candidate. The failure to comply
with any post-approval regulatory requirements also could also result in the
rescission of the related regulatory approvals or the suspension of sales of the
offending product.
18
Our
current and planned clinical trials of our product candidates may fail to show
that these product candidates are clinically safe and effective.
Our Phase
IIa clinical trial and open-label extension clinical trial of arimoclomol for
the treatment of ALS indicated that arimoclomol was safe and well-tolerated in
patients, but the results of the open-label extension clinical trial indicated
only a non-statistically significant trend of improvement in the ALSFRS-R in the
arimoclomol high-dose group as compared with reports of previous studies of
untreated patients. This trial did not have concurrent placebo control group, so
we could draw no definitive conclusions with respect to efficacy. Further
development of arimoclomal for ALS and stroke recovery, as well as clinical
development of iroxanadine for diabetic foot ulcers, would require significant
additional testing, and it is possible that the favorable safety data we
observed in earlier trials may not be reproduced in any later
trials.
Tamibarotene
has been shown to be safe, well-tolerated, and efficacious in the Japanese
population. However, it is possible that the response to the drug may
be different in American/European populations. Furthermore, the
efficacy studies that led to approval in Japan occurred prior to the advent of
the use of ATO for second line therapy. It is possible that the
current use of ATO could alter the safety or efficacy of
tamibarotene. Finally, the FDA may not accept the Japanese studies as
a database for safety in the US.
INNO-206
was no more toxic than free doxorubicin in a Phase I clinical trial and showed
limited biological responses against tumors. However, these
conclusions may not be reproducible in larger clinical
trials. Furthermore, future clinical trials will likely include
multiple dosing with INNO-206 instead of the single doses used in the Phase I
clinical trial.
Later
trials also may not yield statistically significant data indicating that these
product candidates are clinically effective. Accordingly, we, or any development
partners, may ultimately be unable to provide the FDA with satisfactory data on
clinical safety and efficacy sufficient to obtain FDA approval of tamibarotene,
INNO-206, arimoclomol or iroxanadine for these indications.
The
FDA placed a clinical hold on our Phase IIb efficacy trial of arimoclomol for
ALS, which will delay further development of arimoclomol.
In
January 2008, the FDA placed a clinical hold on our Phase IIb clinical efficacy
trial of arimoclomol for the treatment of ALS due to concerns relating to
previous toxicology studies of arimoclomol in rats. We have submitted additional
information to the FDA regarding these concerns, and we are completing
additional animal toxicology studies to obtain additional safety data that we
plan to submit to the FDA in the second quarter of 2009. We cannot
predict the results of these additional studies, however, or how long the FDA
may take to complete its review. Depending on the outcome of the FDA’s review,
the FDA could require:
·
|
additional
toxicology or human studies prior to or in parallel with the resumption of
clinical trials, which would result in substantial additional expenses and
possible significant delays in completing the clinical trials;
or
|
·
|
changes
in the design of our previously planned Phase IIb clinical efficacy
trial, including a reduction in the planned dosage of arimoclomol, which
could delay further or increase the cost of the trial, adversely affect
our ability to demonstrate the efficacy of arimoclomol in the trial or
cause the cancellation of the trial altogether due to one or more of these
consideration.
|
If we are
unable to resolve the FDA’s safety concerns, the FDA may prohibit the resumption
of trials of arimoclomol for the treatment of ALS and all other
indications.
Even
if we obtain regulatory approval for our product candidates, these product
candidates may not achieve market acceptance or be profitable.
We do not
expect to receive regulatory approvals for the commercial sale of any of our
product candidates for several years, if at all. Even
if we do receive regulatory approvals, the future commercial success of these
drug candidates will depend, among other things, on their acceptance by
physicians, patients, healthcare payors and other members of the medical
community as therapeutic and cost-effective alternatives to commercially
available products. If our product candidates fail to gain market acceptance, we
may not be able to earn sufficient revenues to continue our
business.
19
Any
drugs we develop may become subject to unfavorable pricing regulations,
third-party reimbursement practices or healthcare reform initiatives, which
could have a material adverse effect on our business.
We intend
to sell our products primarily to hospitals which receive reimbursement for the
health care services they provide to their patients from third-party payors,
such as Medicare, Medicaid and other domestic and international government
programs, private insurance plans and managed care programs. Most third-party
payors may deny reimbursement if they determine that a medical product was not
used in accordance with cost-effective treatment methods, as determined by the
third-party payor, or was used for an unapproved indication. Third-party payors
also may refuse to reimburse for experimental procedures and devices.
Furthermore, because our programs are in the early stages of development, we are
unable at this time to determine their cost-effectiveness and the level or
method of reimbursement. Increasingly, the third-party payors who reimburse
patients are requiring that drug companies provide them with predetermined
discounts from list prices, and are challenging the prices charged for medical
products. If the price we are able to charge for any products we develop is
inadequate in light of our development and other costs, our profitability could
be adversely effected.
We
currently expect that any drugs we develop may need to be administered under the
supervision of a physician. Under currently applicable law, drugs that are not
usually self-administered may be eligible for coverage by the Medicare program
if:
·
|
they
are “incidental” to a physician’s
services,
|
·
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they
are “reasonable and necessary” for the diagnosis or treatment of the
illness or injury for which they are administered according to accepted
standard of medical practice,
|
·
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they
are not excluded as immunizations,
and
|
·
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they
have been approved by the FDA.
|
We
may rely upon third parties in connection with the commercialization of our
products.
We
currently plan to continue the development of tamibarotene for the treatment of
APL through a third-party clinical trials management service, and may retain the
services of site management and clinical research organizations to help conduct
our other clinical trials. We may seek to complete the development of
tamibarotene and market it ourselves if it is approved by the FDA. However, the
completion of the development of tamibarotene and our other product candidates,
as well as the marketing of these products, may require us to enter into
strategic alliances, license agreements or other collaborative arrangements with
other pharmaceutical companies under which those companies will be responsible
for one or more aspects of the commercial development and eventual marketing of
our products.
Our
products may not have sufficient potential commercial value to enable us to
secure strategic arrangements with suitable companies on attractive terms, or at
all. If we are unable to enter into such arrangements, we may not have the
financial or other resources to complete the development of any of our products
and may have to sell our rights in them to a third party or abandon their
development altogether.
To the
extent we enter into 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 FDA and other regulatory requirements, we may not obtain regulatory
approvals as planned, if at all, and the timing of receipt or the amount of
revenue 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, the profitability to us of these products
may decline.
We
may be unable to protect our intellectual property rights, which could adversely
affect our ability to compete effectively.
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. We will be able to
protect our technologies from unauthorized use by third parties only to the
extent that we have rights to valid and enforceable patents or other proprietary
rights that cover them. Although we have patents and patent applications
directed to our molecular chaperone amplification technologies,
these
20
patents
and applications may not prevent third parties from developing or
commercializing similar or identical technologies. In addition, our patents may
be held to be invalid if challenged by third parties, and our patent
applications may not result in the issuance of patents.
The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions for which important
legal principles remain unresolved. No consistent policy regarding the breadth
of claims allowed in biotechnology patents has emerged to date in the U.S. and
in many foreign countries. The application and enforcement of patent laws and
regulations in foreign countries is even more uncertain. Accordingly, we may not
be able to effectively file, protect or defend our proprietary rights on a
consistent basis. Many of the patents and patent applications on which we rely
were issued or filed by third parties prior to the time we acquired rights to
them. The validity, enforceability and ownership of those patents and patent
applications may be challenged, and if a court decides that our patents are not
valid, we will not have the right to stop others from using our inventions.
There is also the risk that, even if the validity of our patents is upheld, a
court may refuse to stop others on the ground that their activities do not
infringe our patents.
Any
litigation brought by us to protect our intellectual property rights 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 developing or
commercializing similar or identical technologies, the value of our assets is
likely to be materially and adversely affected.
We also
rely on certain proprietary trade secrets and know-how, especially where we
believe patent protection is not appropriate or obtainable. However, trade
secrets and know-how are difficult to protect. Although we have taken measures
to protect our unpatented trade secrets and know-how, including the use of
confidentiality and invention assignment agreements with our employees,
consultants and some of our contractors, it is possible that these persons may
disclose our trade secrets or know-how or that our competitors may independently
develop or otherwise discover our trade secrets and know-how.
If
our product candidates infringe the rights of others, we could be subject to
expensive litigation or be required to obtain licenses from others to develop or
market them.
Our
competitors or others may have patent rights that they choose to assert against
us or our licensees, suppliers, customers or potential collaborators. Moreover,
we may not know about patents or patent applications that our products would
infringe. For example, because patent applications can take many years to issue,
there may be currently pending applications, unknown to us, that may later
result in issued patents that our arimoclomol, iroxanadine or other product
candidates would infringe. In addition, if third parties file patent
applications or obtain patents claiming technology also claimed by us in issued
patents or pending applications, we may have to participate in interference
proceedings in the US Patent and Trademark Office to determine priority of
invention. If third parties file oppositions in foreign countries, we may also
have to participate in opposition proceedings in foreign tribunals to defend the
patentability of our foreign patent applications.
If a
third party claims that we infringe its proprietary rights, any of the following
may occur:
·
|
we
may become involved in time-consuming and expensive litigation, even if
the claim is without merit;
|
·
|
we
may become liable for substantial damages for past infringement if a court
decides that our technology infringes a competitor’s
patent;
|
·
|
a
court may prohibit us from selling or licensing our product without a
license from the patent holder, which may not be available on commercially
acceptable terms, if at all, or which may require us to pay substantial
royalties or grant cross licenses to our patents;
and
|
·
|
we
may have to redesign our product candidates or technology so that it does
not infringe patent rights of others, which may not be possible or
commercially feasible.
|
If any of
these events occurs, our business and prospects will suffer and the market price
of our common stock will likely decline substantially.
21
We have
reported, in the past, material weaknesses in the effectiveness of our internal
controls over financial reporting, and if we cannot maintain effective internal
controls or provide reliable financial and other information, investors may lose
confidence in our SEC reports.
Within
the past several years:
·
|
we
identified a material weakness related to our accounting for an equity
transaction by RXi and our tax withholding in connection with exercises of
employee stock options. As a result, we restated our financial statements
for the quarter ended June 30, 2007 and extended the filing of our
quarterly report for the quarter ended September 30,
2007;
|
·
|
we
identified a material weakness related to our accounting for transactions
at our former laboratory facility in Worcester, Massachusetts. As a
result, we restated our financial statements for the quarters ended March
31, 2006, June 30, 2006 and September 30,
2006;
|
·
|
we
improperly applied generally accepted accounting principles related to our
accounting for deemed dividends incurred in connection with anti-dilution
adjustments made to our outstanding warrants. This misapplication of
accounting principles constituted a material weakness and caused us to
twice restate our financial statements for the quarters ended March 31,
2005, June 30, 2005 and September 30, 2005 and for the year ended December
31, 2005, as well as restate our financial statements for the quarters
ended March 31, 2006, June 30, 2006 and September 30, 2006;
and
|
·
|
we
miscalculated pro forma employee stock option compensation figures
disclosed in the footnotes to our financial statements. As a result, we
restated our financial statements for the quarters ended March 31, 2005,
June 30, 2005 and September 30, 2005 and for the year ended December 31,
2005.
|
In
addition, we concluded in our annual report for the year ended December 31, 2007
and in our quarterly reports for the quarters ended March 31, 2008 and June 30,
2008, that our disclosure controls and procedures were ineffective as of those
dates. Disclosure controls generally include controls and procedures designed to
ensure that information required to be disclosed by us in the reports we file
with the SEC is recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms. In January 2008, we also filed
an amendment to an SEC report to correct certain form errors.
Effective
internal controls over financial reporting and disclosure controls and
procedures are necessary for us to provide reliable financial and other reports
and effectively prevent fraud. If we cannot maintain effective internal controls
or provide reliable financial or SEC reports or prevent fraud, investors may
lose confidence in our SEC reports, our operating results and the trading price
of our common stock could suffer and we may become subject to
litigation.
We
are subject to intense competition, and we may not compete
successfully.
We and
our strategic partners or licensees may be unable to compete successfully
against our current or future competitors. The pharmaceutical, biopharmaceutical
and biotechnology industries are 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 us and at least some of our present or future strategic
partners or licensees.
As a
result, these competitors may:
·
|
succeed
in developing competitive products sooner than us or our strategic
partners or licensees;
|
·
|
obtain
FDA or foreign governmental approvals for their products before we can
obtain approval of any of our
products;
|
·
|
obtain
patents that block or otherwise inhibit the development and
commercialization of our product candidate
candidates;
|
·
|
develop
products that are safer or more effective than our
products;
|
22
·
|
devote
greater resources than us to marketing or selling
products;
|
·
|
introduce
or adapt more quickly than us to new technologies and other scientific
advances;
|
·
|
introduce
products that render our products
obsolete;
|
·
|
withstand
price competition more successfully than us or our strategic partners or
licensees;
|
·
|
negotiate
third-party strategic alliances or licensing arrangements more effectively
than us; and
|
·
|
take
better advantage than us of other
opportunities.
|
Companies
that currently sell generic and proprietary compounds for the treatment of
cancer and related diseases include, but are not limited to, Abraxis BioScience,
Amgen, Sanofi-Aventis, Bayer, Bristol-Myers Squibb, Celgene, Cephalon,
Genentech, Eli Lilly, Johnson & Johnson and Novartis. Alternative
technologies are being developed to treat cancer and related diseases by
numerous companies including Bristol-Myers Squibb, Eisai, Merck and Genentech,
several of which are in advanced clinical trials. There also are FDA approved
cancer therapies that are in the late stage of development by larger established
companies for new cancer indications: Alimta (Eli Lilly), Avastin (Genentech),
Eloxatin (Sanofi-Aventis), Erbitux (Bristol-Myers Squibb and Imclone Systems)
and Tarceva (Genentech). Poniard Pharmaceuticals and Celgene are developing
compounds for SCLC. Novartis and Bristol-Myers Squibb have each developed a
treatment for chronic myelogenous leukemia that would compete with
INNO-406. ATRA and Cephalon’s Trisenox (arsenic trioxide) could compete
with tamibarotene. In addition, companies pursuing different but related
fields represent substantial competition. Any of these competing therapies
could prove to be more effective than INNO-406, tamibarotene, INNO-206 or any
future therapy of ours.
We are
aware of only one drug, Rilutek, which was developed by Aventis Pharma AG, that
has been approved by the FDA for the treatment of ALS. Many companies are
working to develop pharmaceuticals to treat ALS, including Aeolus
Pharmaceuticals, Celgene Corporation, Mitsubishi Tanabe Pharma Corporation, Ono
Pharmaceuticals, Trophos SA, Knopp Neurosciences Inc., Faust Pharmaceuticals SA,
Oxford BioMedica plc, Phytopharm plc and Teva Pharmaceutical Industries Ltd., as
well as RXi. ALS patients often take over-the-counter supplements, including
vitamin E, creatine and coenzyme Q10, or drugs such as lithium that are approved
for other indications. ALS belongs to a family of neurodegenerative diseases
that includes Alzheimer’s, Parkinson’s and Huntington’s diseases. Due to
similarities between these diseases, a new treatment for one such disease
potentially could be useful for treating others. There are many companies
producing and developing drugs used to treat neurodegenerative diseases other
than ALS, including Amgen, Inc., Biogen Idec, Boehringer Ingelheim, Cephalon,
Inc., Ceregene, Inc., Elan Pharmaceuticals, plc, Forest Laboratories, Inc., H.
Lundbeck A/S, Phytopharm plc, UCB Group and Wyeth.
Current
drug classes used to treat stroke include antiplatelet agents, anticoagulants,
salycylates, neuroprotectants and thrombolytic agents. Prescription antiplatelet
agents include Aggrenox by Boehringer Ingelheim, Plavix by Sanofi-Aventis and
Bristol-Myers Squibb, and Ticlid by Roche Pharmaceuticals. Coumadin by
Bristol-Myers Squibb and Jantoven by Upsher-Smith Laboratories are branded forms
of warfarin, an anticoagulant. Moreover, Salicylates, like aspirin, are commonly
used to treat patients after stroke. In Europe, Ferrer Grupo markets the
neroprotectant, Somazina. Activase, also known as tissue plasminogen activator,
or t-PA, is a thrombolytic agent marketed by Genentech. Many new drug candidates
are in development by pharmaceutical and biotech companies, including
GlaxoSmithKline, Ipsen, Merck & Co., Ono Pharmaceuticals, PAION AG and
Wyeth. In addition to drug therapy, companies such as Medtronic and Northstar
Neurosciences are developing neurostimulation medical devices to aid in recovery
after stroke.
Most of
our competitors have substantially greater research and product development
capabilities and financial, technical, scientific, manufacturing, marketing,
distribution and other resources than us.
We
will be required to pay substantial milestone and other payments relating to the
commercialization of our products.
The
agreement under which we have North American rights to tamibarotene provides for
our payment of royalties based on net sales of any products, as well as
aggregate payments of $4.165 million upon meeting specified clinical, regulatory
and sales milestones up to and including the first commercial sale of
tamibarotene for the treatment of APL.
23
The
agreement relating to our worldwide rights to INNO-206 provides for our payment
of an aggregate of $7.5 million upon meeting specified clinical and regulatory
milestones up to and including the product’s second final marketing
approval. We also will be obliged to pay:
·
|
commercially
reasonable royalties based on a percentage of net sales (as defined in the
agreement);
|
·
|
a
percentage of non-royalty sub-licensing income (as defined in the
agreement); and
|
·
|
milestones
of $1,000,000 for each additional final marketing approval that we might
obtain.
|
If we are
required to pay any third party in order to exercise our rights under the
agreement, we will deduct a percentage of those payments from the royalties due
under the agreement, up to an agreed-upon cap.
Our
agreement relating to our worldwide (except Japan) bafetinib provides for our
payment of an aggregate of $13.35 million (including $5 million upon the
product’s initial final marketing approval) upon the achievement of specified
clinical and regulatory milestones up to and including approvals in the U.S. and
Europe. We also will be obliged to pay:
·
|
commercially
reasonable royalties based on a percentage of net sales (as defined in the
agreement), dependent on reaching certain revenue
thresholds;
|
·
|
annual
minimum payments if sales of bafetinib do not meet specified levels;
and
|
·
|
a
percentage of non-royalty sub-licensing income (as defined in the
agreement).
|
Under the
merger agreement by which we acquired Innovive, we agreed to pay the former
Innovive stockholders also will be entitled to receive up to $1.01 per Innovive
share of future earnout merger consideration, subject to our achievement of
specified net sales under the Innovive license agreements. The
earnout merger consideration, if any, will be payable in shares of our common
stock, subject to specified conditions, or, at our election, in cash or by a
combination of shares of our common stock and cash. Our common stock
will be valued for purposes of any future earnout merger consideration based
upon the trading price of our common stock at the time the earnout merger
consideration is paid.
Our
agreement by which we acquired rights to arimoclomol and our other molecular
chaperone amplification product candidates provides for milestone payments by us
upon the occurrence of specified regulatory filings and approvals related to the
acquired products. In the event that we successfully develop arimoclomol or any
of these other product candidates, these milestone payments could aggregate as
much as $3.7 million, with the most significant payments due upon the first
commercialization of any of these products. In addition, our agreement with the
ALS CRT requires us to pay a one-percent royalty interest on worldwide sales of
arimoclomol for the treatment of ALS. Also, any future license, collaborative or
other agreements we may enter into in connection with our development and
commercialization activities may require us to pay significant milestone,
license and other payments in the future.
We
will rely upon third parties for the manufacture of our clinical product
supplies.
We do not
have the facilities or expertise to manufacture supplies of any of our product
candidates, including tamibarotene, INNO-206, arimoclomol or iroxanadine.
Accordingly, we are dependent upon third-party manufacturers, or potential
future strategic alliance partners, to manufacture these supplies. We have
manufacturing supply arrangements in place with respect to a portion of the
clinical supplies needed for the clinical development programs for tamibarotene
and arimoclomol. However, we have no supply arrangements for the commercial
manufacture of these product candidates or any manufacturing supply arrangements
for any other potential product candidates, and we may not be able to secure
needed supply arrangements on attractive terms, or at all. Our failure to secure
these arrangements as needed could have a materially adverse effect on our
ability to complete the development of our products or to commercialize
them.
If our
product candidates cannot be manufactured in suitable quantities and in
accordance with regulatory standards, our clinical trials, regulatory approvals
and marketing efforts for such products may be delayed. Such delays could
adversely affect our competitive position and our chances of generating
significant recurring revenues. If our products are not able to be manufactured
at an acceptable cost, the commercial success of our products may be adversely
affected.
24
We
are subject to potential liabilities from clinical testing and future 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, if we obtain
marketing approval and commercialize our products, 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 maintain clinical
trial insurance for our Phase II clinical trial of tamibarotene for APL,
and we plan to seek to obtain similar insurance for any other clinical trials
that we conduct. We also would seek to obtain product liability insurance
covering the commercial marketing of our product candidates. We may not be able
to obtain additional insurance, however, and any insurance obtained by us may
prove inadequate in the event of a claim against us. Any claims asserted against
us also may divert management’s attention from our operations, and we may have
to incur substantial costs to defend such claims even if they are
unsuccessful.
We
may be unable to successfully acquire additional technologies or products. If we
require additional technologies or products, our product development plans may
change and the ownership interests of our shareholders, or our ownership
interest in RXi, could be diluted.
We may
seek to acquire additional technologies by licensing or purchasing such
technologies, or through a merger or acquisition of one or more companies that
own such technologies. We have no current understanding or agreement to acquire
any technologies, however, and we may not be able to identify or successfully
acquire any additional technologies. We also may seek to acquire products from
third parties that already are being marketed or have been approved for
marketing, although we have not currently identified any of these products. We
do not have any prior experience in acquiring or marketing products approved for
marketing and may need to find third parties to market any products that we
might acquire.
Following
our acquisition of Innovive in September 2008, we refocused our product
development efforts on tamiboratene, which we acquired from Innovive and which
we believe has the greatest near-term revenue potential of all of our other
product candidates. If we acquire additional technologies or product
candidates, we may determine to make further changes to our product development
plans and business strategy to capitalize on opportunities presented by the new
technologies and product candidates.
We may
determine to issue shares of our common stock, or to use shares of RXi common
stock owned by us, or both, to acquire additional technologies or products or in
connection with a merger or acquisition of another company. To the extent we do
so, the ownership interest of our stockholders, or our ownership interest in
RXi, or both, will be diluted accordingly.
We
use hazardous materials and must comply with environmental, health and safety
laws and regulations, which can be expensive and restrict how we do
business.
Our
research and development and manufacturing processes involve the controlled
storage, use and disposal of hazardous materials, including biological hazardous
materials. We are subject to federal, state and local regulations governing the
use, manufacture, storage, handling and disposal of these materials and waste
products. Although we believe that our safety procedures for handling and
disposing of these hazardous materials comply with the standards prescribed by
law and regulation, we cannot completely eliminate the risk of accidental
contamination or injury from hazardous materials. In the event of an accident,
we could be held liable for any damages that result. We could incur significant
costs to comply with current or future environmental laws and
regulations.
Risks
Associated With Our Investment in RXi
We
may sell or dispose of some of our RXi shares, and may not be able to do so on
attractive terms.
As of
March 11, 2009, we owned approximately 6,268,881 shares of common stock of RXi,
or approximately 45% of the outstanding RXi common stock. RXi shares are listed
on The Nasdaq Capital Market under the symbol
“RXi.” During the 12-month period ended March 11, 2009, the market prices for
RXi shares as reported on The Nasdaq Capital Market has fluctuated
from a high of $23.95 per share to a low of $2.71 per share, and the market
price of RXi shares and the value of our RXi shares may continue to experience
significant volatility. We believe that the downturn in the financial markets,
in particular, and poor economy, generally, have contributed to the volatility
of the market price of RXi shares.
25
We may
determine to sell or otherwise dispose of our RXi shares in one or more
transactions in order to obtain funds to carry on our operations or in
connection with our acquisition of new technologies or
products. There is no assurance, however, whether, or on what terms,
we might be able to sell or dispose of our RXi shares. We believe that the
downturn in the financial markets has adversely affected the market for shares
of development-stage companies such as RXi.
If we
undertake to sell our RXi shares, we may have to do so pursuant to Rule 144
under the Securities Act, which includes certain manner of sale and volume
limitations, or seek to negotiate private sales with third parties who are
willing to buy those shares. We may be unable to sell or divest our RXi shares
at attractive prices, if at all. In addition, any sales or other disposition of
RXi shares by us, or the possibility of such sales or disposition, could
adversely affect the market price of our remaining RXi shares.
If
RXi undertakes future financings, our ownership interest in RXi may be
diluted.
Under our
agreement with RXi, with some exceptions, we will have preemptive rights to
acquire a portion of any new securities sold or issued by RXi so as to maintain
our percentage ownership of RXi. Depending upon the terms and provisions of any
proposed sale of new securities by RXi, our financial condition and other
factors, we may be unwilling or unable to exercise our preemptive rights. We
agreed to waive our preemptive rights in connection with a private placement by
RXi in June 2008, which resulted in a reduction in our percentage ownership of
RXi from approximately 49% to approximately 45%. If RXi undertakes future
issuances of equity securities, our percentage ownership interest in RXi may be
diluted further.
We
do not control RXi, and the officers, directors and other RXi stockholders may
have interests that are different from ours.
Although
we currently own a significant portion of RXi’s outstanding common stock, we do
not control its management or operations. RXi has its own board of directors and
management, who are responsible for the affairs and policies of RXi and its
development plans. We have entered into letter agreements with RXi and certain
of its stockholders under which we agree to vote our shares of RXi common stock
for the election of directors of RXi and to take other actions to ensure that a
majority of RXi’s board of directors are independent of us. The board of
directors and other stockholders of RXi may have interests that are different
from ours, and RXi may engage in actions in connection with its business and
operations that we believe are not in our best interests.
Risks
Associated with Our Common Stock
Our
common stock may be delisted from The Nasdaq Capital Market if the stock price
does not increase.
We
received notice from The Nasdaq Stock Market on May 28, 2008 that we were not in
compliance with the minimum $1.00 closing bid price required by Nasdaq
Marketplace Rule 4310(c)(4) and, in accordance with Marketplace Rule
4310(c)(8)(D), could regain compliance if, by November 24, 2008, our common
stock closes at or above $1.00 for 10 consecutive business days and we otherwise
meet the Nasdaq's continuing listing requirements. On
October 16, 2008, Nasdaq announced that it had temporarily suspended until
January 16, 2009 the enforcement of its rules requiring a minimum $1.00
closing bid price. On December 19, 2008, Nasdaq extended the temporary
suspension of its minimum bid price rule. As a result, we will have until
April 20, 2009 to regain compliance with this rule, assuming no further
actions by Nasdaq in this regard. However, in its original notice to
us on May 28, 2008, Nasdaq also informed us that, if we did not regain
compliance by the stated deadline, we would be granted up to an additional 180
calendar days to regain full compliance while continuing to trade during such
time if we meet the Nasdaq's initial listing requirements other than the minimum
bid price rule. If we eventually fail to comply with this condition
for continued listing and our common stock is delisted from The Nasdaq Small
Capital Market, there is no assurance that our common stock will be listed for
trading or quoted elsewhere and an active trading market for our common stock
may cease to exist, which would 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 are intended to
protect our stockholders’ interests by encouraging anyone seeking control of our
company to negotiate with our board of directors. These provisions may
discourage or prevent a person or group from acquiring us without the approval
of our board of directors, even if the acquisition would be beneficial to our
stockholders.
26
We have a
classified board of directors, which means 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 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 potential acquirers to lose interest in a
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, these
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.
We are
also subject to the anti-takeover provisions of Section 203 of the Delaware
General Corporation Law, which may also prevent or delay a takeover of us that
may be beneficial to you.
Our
outstanding options and warrants and the availability for resale of our shares
issued in our private financings may adversely affect the trading price of our
common stock.
As of
December 31, 2008, there were outstanding stock options and warrants to purchase
approximately 18.0 million shares of our common stock at a
weighted-average exercise price of $1.58 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. The issuance of shares upon the exercise of outstanding options and
warrants will also dilute the ownership interests of our existing stockholders.
Many of our outstanding warrants contain anti-dilution provisions pertaining to
dividends with respect to our common stock. Outstanding warrants to purchase
approximately 9.3 million shares contain anti-dilution provisions that are
triggered upon any issuance of securities by us below the prevailing market
price of our common stock. Our distribution to our stockholders of
RXi shares on March 11, 2008 required us to reduce the exercise price of those
warrants. In the event that these anti-dilution provisions are triggered by us
in the future, we would likewise be required to reduce the exercise price, and
increase the number of shares underlying, those warrants, which would have a
dilutive effect on our stockholders.
We have
registered with the SEC the resale by the holders of all or substantially all
shares of our common stock issuable upon exercise of our outstanding options and
warrants. The availability of these shares for public resale, as well as actual
resales 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 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.
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 ranged from $0.23 to $5.49 per share since
January 1, 2007, and it may continue to experience significant volatility from
time to time. Our ability to raise capital has been materially and adversely
affected by the
27
downturn
in the financial markets and poor economy, which have severely depressed the
market for PIPEs transactions on which we have relied for raising needed
capital.
Other
factors that may affect the market price of our common stock include the
following:
·
|
announcements
of regulatory developments or technological innovations by us or our
competitors;
|
·
|
changes
in our relationship with our licensors and other strategic
partners;
|
·
|
changes
in our ownership of or other relationships with
RXi;
|
·
|
our
quarterly operating results;
|
·
|
litigation
involving or affecting us;
|
·
|
shortfalls
in our actual financial results compared to our guidance or the forecasts
of stock market analysts;
|
·
|
developments
in patent or other technology ownership
rights;
|
·
|
acquisitions
or strategic alliances by us or our
competitors;
|
·
|
public
concern regarding the safety of our products;
and
|
·
|
government
regulation of drug pricing.
|
We have
not declared or paid any cash dividends on our common stock or other securities,
and we currently do not anticipate paying any cash dividends in the foreseeable
future. Because we do not anticipate paying cash dividends for the foreseeable
future, our stockholders will not realize a return on their investment in our
common stock except to the extent of any appreciation in the value of our common
stock. Our common stock may not appreciate in value, or may decline in
value.
Item
2. PROPERTIES
Our
headquarters are located in leased facilities in Los Angeles, California. The
lease covers approximately 4,700 square feet of office space and expires in June
2012. This lease currently requires us to make monthly payments of approximately
$18,081.
We also
lease approximately 10,000 square feet of office and laboratory space in San
Diego, California. The lease expires in July 2010, although we have the option
to extend the lease for up to two additional three-year terms. Our headquarters
and laboratory facilities are sufficient for our current purposes.
We also
acquired a sublease to approximately 5,526 square feet of office space at 555
Madison Avenue, New York, New York, in connection with our acquisition of
Innovive in September 2008. This lease currently requires us to make
annual payments of approximately $210,000, plus certain taxes and operating
expenses, and it expires on August 30, 2012. On December 4, 2008, we
sub-subleased the space to Red Pine Advisors LLC through August 29, 2012.
Under the sub-sublease, we are entitled to base annual rent of approximately
$350,000, plus certain taxes and operating expenses.
Item
3. LEGAL PROCEEDINGS
We are
occasionally involved in claims arising in the normal course of business. As of
March 11, 2009, there were no such claims that we expect, individually or in the
aggregate, to have a material adverse affect on us.
28
PART
II
Item
5. MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Market
Information
Our
common stock is traded on The NASDAQ Capital 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 Capital Market:
High
|
Low
|
|
Fiscal
Year 2008:
|
||
Fourth
Quarter
|
$0.65
|
$0.23
|
Third
Quarter
|
$0.68
|
$0.40
|
Second
Quarter
|
$1.27
|
$0.61
|
First
Quarter
|
$2.98
|
$1.00
|
Fiscal
Year 2007:
|
||
Fourth
Quarter
|
$4.70
|
$2.60
|
Third
Quarter
|
$4.09
|
$3.00
|
Second
Quarter
|
$5.36
|
$2.97
|
First
Quarter
|
$5.49
|
$1.74
|
Holders
On March
11, 2009, there were approximately 785 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
nominees.
Dividends
We have
not paid any cash dividends since our inception and do not contemplate paying
any cash dividends in the foreseeable future. On March 11, 2008, we
distributed to our stockholders approximately 36% of the outstanding shares of
RXi on approximately a 1-for-20 basis.
Equity
Compensation Plans
The
following table sets forth certain information as of December 31, 2008,
regarding securities authorized for issuance under our equity compensation
plans:
Plan
Category
|
(a)
Number
of Securities
to
be Issued Upon
Exercise
of
Outstanding
Options,
Warrants and Rights
|
(b)
Weighted-Average
Exercise
Price of
Outstanding
Options,
Warrants and Rights
|
Number
of Securities
Remaining
Available
for
Issuance Under
Equity
Compensation
Plans
(Excluding
Securities
Reflected
in Column (a))
|
|||||||||
Equity
compensation plans approved by our security holders:
|
||||||||||||
2000
Long-Term Incentive Plan
|
7,054,940 | $ | 1.92 | 697,000 | ||||||||
Equity
compensation plans not approved by our security holders:
|
||||||||||||
2008
Stock Incentive Plan (1)
|
350,000 | 0.35 | — | |||||||||
Outstanding
warrants (2)
|
10,634,848 | 1.40 | — | |||||||||
Total
|
18,039,788 | $ | 1.58 | 697,000 |
____________
(1)
|
Our
board of directors adopted this plan on November 21, 2008. The
plan will be submitted for approval by our stockholders at our 2009 Annual
Meeting of stockholders. In the meantime, we may make awards
under the plan, whose effectiveness is conditioned upon obtaining
stockholder approval.
|
29
(2)
|
The
warrants shown were issued in discreet transactions from time to time as
compensation for services rendered by consultants, advisors or other third
parties, and do not include warrants sold in private placement
transactions. The material terms of such warrants were determined based
upon arm’s-length negotiations with the service providers. The warrant
exercise prices approximated the market price of our common stock at or
about the date of grant, and the warrant terms range from five to ten
years from the grant date. The warrants contain customary anti-dilution
adjustments in the event of a stock split, reverse stock split,
reclassification or combination of our outstanding common stock and
similar events and certain of the warrants contain anti-dilution
adjustments triggered by other corporate events, such as dividends and
sales of equity below market price.
|
On
November 21, 2008, our compensation committee granted to Joseph Rubinfeld, Ph.D.
stock options under our newly adopted 2008 Stock Incentive Plan to purchase up
to 350,000 shares of our common stock at an exercise price of $0.35 per share,
which equaled the market price of our common stock on the grant
date. The options were granted in connection with the consulting
agreement entered into between us and Dr. Rubinfeld described in the “Certain
Relationships and Related Transactions” section of this Annual Report, and will
become exercisable only upon stockholder approval of the plan. The
grant was made without registration under the Federal securities laws in
reliance upon exemptions from such registration for offers and sales not
involving a public offering.
Comparison
of Cumulative Total Returns
The
following line graph presentation compares cumulative total stockholder returns
of CytRx with The NASDAQ Stock Market Index and the NASDAQ Pharmaceutical Index
(the “Peer Index”) for the five-year period from December 31, 2003 to December
31, 2008. The graph and table assume that $100 was invested in each of CytRx’s
common stock, the NASDAQ Stock Market Index and the Peer Index on December 31,
2003, and that all dividends were reinvested. This data was furnished by Zacks
Investment Research.
Comparison
of Cumulative Total Returns
December 31,
|
|||||
2004
|
2005
|
2006
|
2007
|
2008
|
|
CytRx
Corporation
|
75.27
|
55.37
|
102.68
|
152.67
|
23.42
|
NASDAQ
Stock Market Index
|
109.16
|
111.47
|
123.05
|
140.12
|
84.12
|
NASDAQ
Pharmaceutical Index
|
106.51
|
117.29
|
114.81
|
120.74
|
112.34
|
30
Item 6. SELECTED FINANCIAL DATA
General
The
following selected financial data are derived from our audited financial
statements. Our financial statements for 2008, 2007, and 2006 have been audited
by BDO Seidman, LLP, our independent registered public accounting firm. 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 “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and “Risk Factors” sections of this Annual
Report. Financial information provided below has been rounded to the nearest
thousand.
2008
|
2007
|
2006
|
2005
|
2004
|
||||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||||||
Revenues
|
||||||||||||||||||||
Service
revenue
|
$ | 6,166,000 | $ | 7,242,000 | $ | 1,859,000 | $ | 83,000 | $ | — | ||||||||||
Licensing revenue
|
100,000 | 101,000 | 101,000 | 101,000 | 428,000 | |||||||||||||||
Grant
revenue
|
— | 116,000 | 106,000 | — | — | |||||||||||||||
Total
revenues
|
$ | 6,266,000 | $ | 7,459,000 | $ | 2,066,000 | $ | 184,000 | $ | 428,000 | ||||||||||
Deemed
dividend for anti-dilution adjustments made to outstanding common stock
warrants
|
(757,000 | ) | — | (488,000 | ) | (1,076,000 | ) | — | ||||||||||||
Net
loss applicable to common stockholders
|
$ | (27,803,000 | ) | $ | (21,890,000 | ) | $ | (17,240,000 | ) | $ | (16,169,000 | ) | $ | (16,392,000 | ) | |||||
Basic
and diluted loss per share applicable to common stock
|
$ | (0.30 | ) | $ | (0.26 | ) | $ | (0.25 | ) | $ | (0.28 | ) | $ | (0.48 | ) | |||||
Balance
Sheet Data:
|
||||||||||||||||||||
Cash,
cash equivalents and short-term investments
|
$ | 25,042,000 | $ | 60,450,000 | $ | 30,381,000 | $ | 8,299,000 | $ | 1,988,000 | ||||||||||
Total
assets
|
$ | 28,324,000 | $ | 64,146,000 | $ | 31,636,000 | $ | 9,939,000 | $ | 5,049,000 | ||||||||||
Total
stockholders’ equity
|
$ | 15,698,000 | $ | 40,224,000 | $ | 5,150,000 | $ | 7,208,000 | $ | 1,595,000 |
Factors
Affecting Comparability
On
September 19, 2008, we purchased all of the common stock of Innovive
Pharmaceuticals in a transaction that for accounting purposes is considered an
asset acquisition. The fair value of Innovive’s assets and
liabilities at September 19, 2008, in millions of dollars, are presented
below:
In-process
research and development
|
$ | 8.0 | ||
Leasehold
interests
|
0.1 | |||
Prepaid
expenses
|
0.3 | |||
Accounts
payable
|
(6.1 | ) | ||
Net
assets acquired through issuance of common stock
|
$ | 2.3 |
As a
result of the March 11, 2008 distribution by us to our stockholders of
approximately 36% of the outstanding shares of RXi Pharmaceuticals Corporation,
we deconsolidated that previously majority-owned subsidiary. As part of the
transaction, we deconsolidated $3.7 million of total assets and $4.6 million of
total liabilities.
In
connection with applicable antidilution adjustments to the price of certain
outstanding warrants in March 2008, we recorded a deemed dividend of
approximately $757,000. The deemed dividend was recorded as a charge to
accumulated deficit and a corresponding credit to additional paid-in
capital.
On April
19, 2007, we completed a $37.0 million private equity financing in which we
issued 8.6 million shares of our common stock at $4.30 per share. Net of
investment banking commissions, legal, accounting and other expenses related to
the transaction, we received approximately $34.2 million of
proceeds.
In August
2006, we received approximately $24.5 million in marketable securities (which
were sold by us for approximately $24.3 million) from the privately-funded ALS
Charitable Remainder Trust, or ALSCRT, in exchange for our commitment to
continue
31
research
and development of arimoclomol and other potential treatments for ALS and a one
percent royalty from worldwide sales of arimoclomol. We have recorded the value
received under the arrangement as deferred service revenue. We are recognizing
the service revenue using the proportional performance method of revenue
recognition, under which service revenue will be recognized as a percentage of
actual research and development expense. During 2008 and 2007, we recognized
approximately $6.2 million and $7.2 million of service revenue related to this
transaction, respectively.
Our
Statements of Operations as of and for the years ended December 31, 2008, 2007
and 2006 reflect the impact of Statement of Financial Accounting Standards
123(R), “Share Based
Payment” (“SFAS 123(R)”). In accordance with the modified prospective
transition method, our results of operations for prior periods have not been
restated to reflect the impact of SFAS 123(R). Share-based compensation expense
recognized under SFAS 123(R) for the years ended December 31, 2008, 2007 and
2006 were $2.1 million, $2.7 million and $1.2 million, respectively. As of
December 31, 2008, there was $2.1 million of unrecognized compensation cost
related to outstanding options that is expected to be recognized as a component
of our operating expenses through 2012. Compensation costs will be adjusted for
future changes in estimated forfeitures.
On March
2, 2006, we completed a $13.4 million private equity financing in which we
issued 10,650,795 shares of our common stock and warrants to purchase an
additional 6,070,953 shares of our common stock at an exercise price of $1.54
per share. Net of investment banking commissions, legal, accounting and other
expenses related to the transaction, we received approximately $12.4 million of
proceeds.
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 $19.4
million.
In
connection with our adjustment to the exercise terms of certain outstanding
warrants to purchase common stock on March 2, 2006 and January 20, 2005, we
recorded deemed dividends of $488,000 and $1.1 million, respectively. These
deemed dividends are reflected as an adjustment to net loss for the first
quarter of 2006 and the year ended 2005 to arrive at net loss applicable to
common stockholders on the consolidated statement of operations and for purposes
of calculating basic and diluted earnings per shares.
Item
7. MANAGEMENT’S
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 the caption “Risk Factors”
and elsewhere in this Annual Report.
Overview
CytRx
Corporation
We are a
biopharmaceutical research and development company engaged in the development of
high-value human therapeutics. Our drug development pipeline includes two
product candidates in clinical development for cancer indications, including
registration studies of tamibarotene for the treatment of acute promyelocytic
leukemia, or APL. In addition to our core oncology programs, we are developing
treatments for neurodegenerative and other disorders based upon our
small-molecule molecular chaperone amplification technology. We also are engaged
in new-drug discovery research at our laboratory facility in San Diego,
California, utilizing our master chaperone regulator assay, or MaCRA,
technology. Apart from our drug development programs and new-drug discovery
research activities, we currently maintain a 45% equity interest in our former
subsidiary, RXi Pharmaceuticals Corporation, or RXi (NASDAQ: RXII).
We have
relied primarily upon selling equity securities and upon proceeds received upon
the exercise of options and warrants and, to a much lesser extent, upon payments
from our strategic partners and licensees, to generate funds needed to finance
our business and operations.
32
At
December 31, 2008, we had cash, cash equivalents and short-term investments of
$25.0 million. We believe that CytRx’s current resources will be sufficient to
support its currently planned level of operations through the first quarter of
2010. This estimate is based, in part, upon our currently projected expenditures
for 2009 of approximately $22 million, including approximately $7.1 million for
our clinical program for tamibarotene, approximately $3.4 million for our
clinical program for INNO-206, approximately $0.6 million for our clinical
program for INNO-406, approximately $0.5 million for our animal toxicology
studies and related activities for arimoclomol, approximately $1.8 million for
operating our clinical programs, approximately $2.7 million for research
activities at its laboratory in San Diego, California, and approximately $5.9
million for other general and administrative expenses. Projected
expenditures are based upon numerous assumptions and subject to many
uncertainties, and our actual expenditures may be significantly different from
these projections. We will be required to obtain additional funding in order to
execute its long-term business plans, although we do not currently have
commitments from any third parties to provide us with capital. We cannot assure
that additional funding will be available on favorable terms, or at all. If we
fail to obtain additional funding when needed, we may not be able to execute our
business plans and our business may suffer, which would have a material adverse
effect on our financial position, results of operations and cash
flows.
Our
Separation from RXi Pharmaceuticals Corporation
RXi
Pharmaceuticals Corporation was founded in April 2006 by us and four researchers
in the field of RNAi, including Dr. Craig Mello, recipient of the 2006 Nobel
Prize for Medicine for his co-discovery of RNAi. RNAi is a naturally occurring
mechanism for the regulation of gene expression that has the potential to
selectively inhibit the activity of any human gene. In January 2007, we
transferred to RXi substantially all of our RNAi-related technologies and
assets, and RXi began operating on a stand-alone basis for the purpose of
accelerating the discovery of RNAi therapeutics previously sponsored by us.
RXi’s initial focus is on developing RNAi-based product candidates for treating
neurological and metabolic disorders and cancer.
Until
early 2008, we owned approximately 85% of the outstanding shares of common stock
of RXi and our financial statements, including our financial statements as of
and for the year ended December 31, 2007, included the consolidated financial
condition and results of operations of RXi. On February 14, 2008, our board of
directors declared a dividend of one share of RXi common stock for each
approximately 20.05 shares of our common stock held by such stockholders, which
was paid on March 11, 2008 and which reduced our ownership of RXi shares to
less than 50%.
For
periods beginning with the first quarter of 2008, if CytRx owns more than 20%
but less than 50% of the outstanding shares of RXi, CytRx will account for its
investment in RXi using the equity method. Under the equity method, CytRx will
record its pro-rata share of the gains or losses of RXi against its historical
basis investment in RXi.
Research
and Development
Expenditures
for research and development activities related to continuing operations were
$10.5 million, $18.8 million and $9.8 million for the years ended December 31,
2008, 2007 and 2006, respectively, with research and development expenses
representing approximately 35%, 55% and 50% of our total expenses for the years
ended December 31, 2008, 2007 and 2006, respectively.
Research
and development expenses are further discussed below under “Critical Accounting
Policies and Estimates” and “Results of Operations.”
Our
currently projected expenditures for 2009 include approximately $7.1 million for
our clinical program for tamibarotene, approximately $3.4 million for our
clinical program for INNO-206, approximately $0.6 million for our INNO-406
program, approximately $0.5 million for our animal toxicology studies
and related activities for arimoclomol, approximately $1.8 million for operating
our clinical programs, and approximately $2.7 million for research activities at
our laboratory in San Diego, California. The actual cost of our clinical
programs could differ significantly from our current projections due to any
additional requirements or delays imposed by the FDA in connection with our
planned trials, or if actual costs are higher than current management estimates
for other reasons, including complications with manufacturing. In the event that
actual costs of our clinical program, or any of our other ongoing research
activities, are significantly higher than our current estimates, we may be
required to significantly modify our planned level of operations.
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. The successful
development of any product candidate 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
33
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;
|
·
|
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;
and
|
·
|
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 our business is set forth in the “Risk Factors” section of this Annual
Report.
Critical
Accounting Policies and Estimates
Management’s
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 of
America. 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, stock options, 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 of the Notes to
Financial Statements included in this Annual Report. We believe the following
critical accounting policies are affected by our more significant judgments and
estimates used in the preparation of our consolidated financial
statements:
Revenue
Recognition
Biopharmaceutical
revenues consist of license fees from strategic alliances with pharmaceutical
companies as well as service and grant revenues. Service revenues consist of
contract research and laboratory consulting. Grant revenues consist of
government and private grants.
Monies
received for license fees are deferred and recognized ratably over the
performance period in accordance with Staff Accounting Bulletin (“SAB”) No. 104,
Revenue Recognition.
Milestone payments will be recognized upon achievement of the milestone as long
as the milestone is deemed substantive and we have no other performance
obligations related to the milestone and
34
collectability
is reasonably assured, which is generally upon receipt, or recognized upon
termination of the agreement and all related obligations. Deferred revenue
represents amounts received prior to revenue recognition.
Revenues
from contract research, government grants, and consulting fees are recognized
over the respective contract periods as the services are performed, provided
there is persuasive evidence or an arrangement, the fee is fixed or determinable
and collection of the related receivable is reasonably assured. Once all
conditions of the grant are met and no contingencies remain outstanding, the
revenue is recognized as grant fee revenue and an earned but unbilled revenue
receivable is recorded.
In August
2006, we received approximately $24.3 million in proceeds from the
privately-funded ALS Charitable Remainder Trust (“ALSCRT”) in exchange for the
commitment to continue research and development of arimoclomol and other
potential treatments for ALS and a one percent royalty in the worldwide sales of
arimoclomol. Under the arrangement, we retain the rights to any products or
intellectual property funded by the arrangement and the proceeds of the
transaction are non-refundable. Further, the ALSCRT has no obligation to provide
any further funding to us. We have concluded that due to the research and
development components of the transaction that it is properly accounted for
under Statement of Financial Accounting Standards No. 68, Research and Development Arrangements.
Accordingly, we have recorded the value received under the arrangement as
deferred service revenue and will recognize service revenue using the
proportional performance method of revenue recognition, meaning that service
revenue is recognized on a dollar-for-dollar basis for each dollar of expense
incurred for the research and development of arimoclomol and other potential ALS
treatments. We believe that this method best approximates the efforts expended
related to the services provided. We adjust our estimates of expense incurred
for this research and development on a quarterly basis. For the years ended
December 31, 2008, 2007 and 2006, we recognized approximately $6.2 million, $7.2
million and $1.8 million, respectively, of service revenue related to this
transaction. Any significant change in ALS related research and development
expense in any particular quarterly or annual period will result in a change in
the recognition of revenue for that period and consequently affect the
comparability or revenue from period to period.
The
amount of “deferred revenue, current portion” is the amount of deferred revenue
that is expected to be recognized in the next twelve months and is subject to
fluctuation based upon management’s estimates. Management’s estimates include an
evaluation of what pre-clinical and clinical trials are necessary, the timing of
when trials will be performed and the estimated clinical trial expenses. These
estimates are subject to changes and could have a significant effect on the
amount and timing of when the deferred revenues are recognized.
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, including licenses, that are utilized in research and
development and that have no alternative future use are expensed when incurred.
Technology developed for use in its products is expensed as incurred until
technological feasibility has been established.
Clinical
Trial Expenses
Clinical
trial expenses, which are included in research and development expenses, include
obligations resulting from our contracts with various clinical research
organizations in connection with conducting clinical trials for our product
candidates. We recognize expenses for these activities based on a variety of
factors, including actual and estimated labor hours, clinical site initiation
activities, patient enrollment rates, estimates of external costs and other
activity-based factors. We believe that this method best approximates the
efforts expended on a clinical trial with the expenses we record. We adjust our
rate of clinical expense recognition if actual results differ from our
estimates. If our estimates are incorrect, clinical trial expenses recorded in
any particular period could vary.
Stock-based
Compensation
Our
share-based employee compensation plans are described in Note 13 of the Notes to
our Financial Statements. Effective January 1, 2006, we adopted the provisions
of SFAS 123(R), “Share-Based
Payment.” SFAS 123(R), which requires that companies recognize
compensation expense associated with stock option grants and other equity
instruments to employees in the financial statements. SFAS 123(R) applies to all
grants after the effective date and to the unvested portion of stock options
outstanding as of the effective date. We adopted SFAS 123(R) using the
modified-prospective method and use the Black-Scholes valuation model for
valuing share-based payments. We will continue to account for transactions in
which services are received in exchange for equity instruments based on the fair
value of such services received from non-employees, in accordance with SFAS
123(R), Emerging Issues
35
Task
Force Issue No. 96-18 (“EITF 96-18”), Accounting for Equity Instruments
that are Issued to other than Employees for Acquiring,
or in Conjunction with Selling Goods or Services and EITF 00-18,
Accounting Recognition for
Certain Transactions involving Equity Instruments Granted
to Other Than Employees, as amended.
Our
Statement of Operations as of and for the years ended December 31, 2008, 2007
and 2006 reflects the impact of SFAS 123(R). In accordance with the modified
prospective transition method, our results of operations for prior periods have
not been restated to reflect the impact of SFAS 123(R). Prior to January 1,
2006, we accounted for share-based compensation under the recognition and
measurement provisions of Accounting Principles Board No. 25, Accounting for Stock Issued to
Employees (“APB 25”), and related interpretations for all awards granted
to employees. Under APB 25, when the exercise price of options granted to
employees under these plans equals or exceeds the market price of the common
stock on the date of grant, no compensation expense is recorded. When the
exercise price of options granted to employees under these plans is less than
the market price of the common stock on the date of grant, compensation expense
is recognized over the vesting period.
Non-employee
share-based compensation charges generally are amortized over the vesting period
on a straight-line basis. In certain circumstances, option grants to
non-employees are immediately vested and have no future performance or service
requirements by the non-employee and the total share-based compensation charge
is recorded in the period of the measurement date.
The fair
value of each CytRx and RXi common stock option grant is estimated using the
Black-Scholes option pricing model, which uses certain assumptions related to
risk-free interest rates, expected volatility, expected life of the common stock
options and future dividends. Compensation expense is recorded based upon the
value derived from the Black-Scholes option pricing model, based on an expected
forfeiture rate that is adjusted for actual experience. If our Black-Scholes
option pricing model assumptions or our actual or estimated forfeiture rate are
different in the future, that could materially affect compensation expense
recorded in future periods.
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.
If our estimates used in the determination of either discounted future cash
flows or other appropriate fair value methods are not accurate as compared to
actual future results we may be required to record an impairment
charge.
Earnings
Per 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
and warrants) 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
15.2 million shares, 17.1 million shares and 30.2 million shares at December 31,
2008, 2007 and 2006, respectively. In connection with our adjustment to the
exercise terms of certain outstanding warrants to purchase common stock on March
11, 2008 and March 2, 2006, we recorded deemed dividends of $757,000 and
$488,000, respectively. These deemed dividends are reflected as an adjustment to
net loss for the first quarter of 2008 and the first quarter of 2006 to arrive
at net loss applicable to common stockholders on the consolidated statement of
operations and for purposes of calculating basic and diluted earnings per
shares.
Quarterly
Financial Data
The
following table sets forth unaudited consolidated statements of operations data
for each quarter during our most recent two fiscal years. This quarterly
information has been derived from our unaudited consolidated 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 consolidated financial
36
statements
and related notes. The operating results for any quarter are not necessarily
indicative of the operating results for any future period.
Quarters Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
(In
thousands, except per share data)
|
||||||||||||||||
2008
|
||||||||||||||||
Total
revenues
|
$ | 2,181 | $ | 1,740 | $ | 917 | $ | 1,428 | ||||||||
Net
loss
|
(5,374 | ) | (5,826 | ) | (12,316 | ) | (3,530 | ) | ||||||||
Deemed
dividend for anti-dilution adjustments made to outstanding
common
stock warrants
|
(757 | ) | — | — | — | |||||||||||
Net
loss applicable to common stockholders
|
$ | (6,131 | ) | $ | (5,826 | ) | $ | (12,316 | ) | $ | (3,530 | ) | ||||
Basic
and diluted loss per share applicable to common stock
|
$ | (0.07 | ) | $ | (0.06 | ) | $ | (0.14 | ) | $ | (0.04 | ) | ||||
2007
|
||||||||||||||||
Total
revenues
|
$ | 1,563 | $ | 2,371 | $ | 2,046 | $ | 1,479 | ||||||||
Net
loss
|
(4,546 | ) | (6,285 | ) | (4,597 | ) | (6,462 | ) | ||||||||
Deemed
dividend for anti-dilution adjustments made to outstanding
common
stock warrants
|
— | — | — | — | ||||||||||||
Net
loss applicable to common stockholders
|
$ | (4,546 | ) | $ | (6,285 | ) | $ | (4,597 | ) | $ | (6,462 | ) | ||||
Basic
and diluted loss per share applicable to common stock
|
$ | (0.06 | ) | $ | (0.07 | ) | $ | (0.05 | ) | $ | (0.07 | ) |
Quarterly
and yearly loss per share amounts are computed independently of each other.
Therefore, the sum of the per share amounts for the quarters may not equal the
per share amounts for the year. In 2006, we adopted SFAS 123(R), and in 2008 and
2007 we incurred $2.1 and $2.72 million, respectively, in employee non-cash
compensation expenses.
In
connection with our adjustment to the exercise terms of certain outstanding
warrants to purchase common stock on March 11, 2008, we recorded deemed
dividends of $757,000. These deemed dividends are reflected as an adjustment to
net loss for the first quarter of 2008 to arrive at net loss applicable to
common stockholders on the consolidated statement of operations and for purposes
of calculating basic and diluted earnings per shares.
Fourth
Quarter Adjustment
During
the fourth quarter of 2007, the Company recorded adjustments for: (i) additional
compensation expense of $236,000 related to previously granted non-employee
stock options, (ii) additional compensation expense of $350,000 related to stock
options previously granted to Directors and (iii) additional general and
administrative expense of $192,000 related to legal fees rendered during the
third quarter. Management concluded the effect of these adjustments was not
material to any previously reported quarterly period.
Liquidity
and Capital Resources
General
At
December 31, 2008, we had cash, cash equivalents and short-term investments of
$25.0 million, compared to $60.4 million at December 31, 2007. Our working
capital totaled $20.9 million and our total assets were $28.3 million at
December 31, 2008, compared to $47.4 million and $64.1 million, respectively, at
December 31, 2007.
We have
relied primarily upon selling equity securities and upon proceeds received upon
the exercise of options and warrants and, to a much lesser extent, upon payments
from our strategic partners and licensees, to generate funds needed to finance
our business and operations. We believe that our current resources will be
sufficient to support our currently planned level of operations through the
first quarter of 2010. This estimate is based, in part, upon our currently
projected expenditures for 2009 of approximately $22 million, including
approximately $7.1 million for our clinical program for tamibarotene,
approximately $3.4 million for our clinical program for INNO-206, approximately
$0.6 million for our clinical program for INNO-406, approximately $0.5 million
for our animal toxicology studies and related activities for arimoclomol,
approximately $1.8 million for operating our clinical programs, approximately
$2.7 million for research activities at our laboratory in San Diego, California,
and approximately $5.9 million for other general and administrative expenses.
These projected expenditures are based upon numerous assumptions and subject to
many uncertainties, and our actual expenditures may be significantly different
from these projections. We have no significant revenue, and we expect to have no
significant revenue and to continue to incur significant losses over the next
several years. Our net losses may increase from current levels primarily due to
expenses related to our ongoing and planned clinical trials, research and
development programs, possible technology acquisitions, and other general
corporate activities. We anticipate, therefore, that our operating results will
fluctuate for the foreseeable future and period-to-period comparisons should not
be relied upon as predictive of the results in future periods.
37
Discussion
of Operating, Investing and Financing Activities
Net loss
for the year ended December 31, 2008 was $27.0 million, and cash used for
operating activities for that period was $19.4 million. The net loss for the
year reflects $6.2 million of non-cash revenue recognized under the 2006
agreement with ALSCRT, a non-cash expense of $8.0 million related to the
acquisition of Innovive’s in-process research and development, a non-cash equity
loss in our non-consolidated RXi subsidiary of $3.9 million and $2.1 million for
stock option and warrant expense.
Net loss
for the year ended December 31, 2007 was $21.9 million, and cash used for
operating activities for that period was $22.4 million. The net loss for the
year reflects $7.2 million of non-cash revenue recognized under the 2006
agreement with ALSCRT and $3.5 million for stock option and warrant
expense.
Net loss
for the year ended December 31, 2006 was $16.8 million, and cash provided from
operating activities for that period was $9.4 million. The cash provided from
operating activities includes net proceeds of $24.3 million received from ALSCRT
reflected in August 2006 in connection with the sale of a one-percent royalty
interest in our worldwide sales of arimoclomol for ALS. Reflected in the net
loss of $16.8 million is $1.8 million of revenue recognized in 2006 in
connection with that sale. The remaining $22.5 million of the net proceeds from
that sale were recorded as deferred revenues. Other non-cash items included in
our net loss necessary to reconcile cash provided from operating activities
include $1.7 million in stock option expense related to options granted to
employees and consultants, of which $1.2 million of expenses for employee
options recorded under SFAS 123(R), which we adopted in 2006, and accordingly no
corresponding amount was recorded in earlier periods.
For the
year ended December 31, 2008, $7.0 million was used in investing activities. The
2008 year included $10.0 million of RXi funds resulting from converting
short-term investments to cash equivalents. However, RXi’s cash of $10.4 million
(inclusive of this $10.0 million) is not available to us due to the
deconsolidation. The total cash outlay to acquire Innovive totaled $5.7 million,
which related primarily to the payment of Innovive’s accounts payable. The other
$0.9 million was used for the purchase of equipment and furnishings, primarily
associated with equipping the San Diego laboratory.
For the
year ended December 31, 2007, $11.0 million was used in investing activities. Of
this amount, $9.8 million was used by RXi for the purchase of short-term
investments. The other $1.3 million was used for the purchase of equipment and
furnishings, primarily associated with equipping our San Diego laboratory. We
intend to assess periodically the costs and potential commercial value of our
new-drug discovery activities. Depending on these assessments, we may
determine to modify, out-source, partner or suspend these activities. For the
year ended December 31, 2006, only a small amount of cash was used in investing
activities. Other investing activities consisted primarily of the purchase of
small amounts of computers and laboratory equipment.
Cash
provided by financing activities for the year ended December 31, 2008 was $1.0
million. During 2008, we received $1.0 million from the exercise of
stock options and warrants.
Cash
provided by financing activities for the year ended December 31, 2007 was $53.5
million compared to $12.8 million and $19.8 million in the years ended December
31, 2006 and 2005, respectively. During 2007, we raised $34.2 million in a
private placement of our common stock and an additional $18.8 million from the
exercise of previously outstanding stock options and warrants. During 2006, we
raised $12.4 million through a private placement of our common stock and an
additional $0.4 million from the exercise of stock options and warrants. During
the year ended December 31, 2005, we raised $19.6 million through a private
placement of common stock.
We
believe that we have adequate working capital to allow us to operate at our
currently planned levels through the first quarter of 2010. We may require
additional capital in order to fund the completion of our clinical programs, and
the other ongoing research and development related to our molecular chaperone
amplification drug candidates. We may incur substantial additional expense and
our clinical programs may be delayed if the FDA requires us to generate
additional pre-clinical or clinical data in connection with the clinical trials,
or the FDA requires us to revise significantly our planned protocols for our
planned clinical trials.
At
December 31, 2008, our equity investment in RXi of 6,268,881 common stock had an
approximate fair value of $36.0 million, based on the closing price of RXi
common stock (NASDAQ: “RXII”) on that date. Sale of a portion or all of this
investment would generate additional cash. We also intend to pursue other
sources of capital, although we do not currently have commitments from any third
parties to provide us with capital. Our ability to obtain future financings
through joint ventures, product licensing arrangements, equity financings,
gifts, and grants or otherwise is subject to market conditions and out ability
to identify parties that are willing and
38
able to
enter into such arrangements on terms that are satisfactory to us. Depending
upon the outcome of our fundraising efforts, the accompanying financial
information may not necessarily be indicative of future operating results or
future financial condition.
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.
Off-Balance
Sheet Arrangements
We have
no off-balance sheet arrangements that have a material current effect or that
are reasonably likely to have a material future effect on our financial
condition, changes in financial condition, revenues or expenses, results of
operations, liquidity, capital expenditures, or capital resources.
Contractual
Obligations
We
sometimes acquire assets still in development and enter into research and
development arrangements with third parties that often require milestone and
royalty payments to the third party contingent upon the occurrence of certain
future events linked to the success of the asset in development. Milestone
payments may be required, contingent upon the successful achievement of an
important point in the development life-cycle of the pharmaceutical product
(e.g., approval of the product for marketing by a regulatory agency). If
required by the arrangement, we may have to make royalty payments based upon a
percentage of the sales of the pharmaceutical product in the event that
regulatory approval for marketing is obtained. Because of the contingent nature
of these payments, they are not included in the table of contractual
obligations.
These
arrangements may be material individually, and in the unlikely event that
milestones for multiple products covered by these arrangements were reached in
the same period, the aggregate charge to expense could be material to the
results of operations in any one period. In addition, these arrangements often
give us the discretion to unilaterally terminate development of the product,
which would allow us to avoid making the contingent payments; however, we are
unlikely to cease development if the compound successfully achieves clinical
testing objectives. We also note that, from a business perspective, we view
these payments as positive because they signify that the product is successfully
moving through development and is now generating or is more likely to generate
cash flows from sales of products.
CytRx’s
current contractual obligations that will require future cash payments are as
follows:
Non-Cancelable
|
||||||||||||||||||||
Operating
Leases (1)
|
Employment
Agreements (2)
|
Subtotal
|
Research
and
Development (3)
|
Total
|
||||||||||||||||
2009
|
$ | 521 | $ | 1,610 | $ | 2,131 | $ | 1,758 | $ | 3,889 | ||||||||||
2010
|
376 | — | 376 | 49 | 425 | |||||||||||||||
2011
|
253 | — | 253 | 49 | 302 | |||||||||||||||
2012
|
124 | — | 124 | 149 | 273 | |||||||||||||||
2013 and
thereafter
|
— | — | — | 532 | 532 | |||||||||||||||
Total
|
$ | 1,274 | $ | 1,610 | $ | 2,884 | $ | 2,537 | $ | 5,421 |
____________
(1)
|
Operating
leases are primarily facility lease related obligations, as well as
equipment and software lease obligations with third party
vendors.
|
(2)
|
Employment
agreements include management contracts, which have been revised from time
to time, provide for minimum salary levels, adjusted annually at the
discretion of the Company’s Compensation Committee, as well as for minimum
bonuses that are payable.
|
(3)
|
Research
and development obligations relate primarily to clinical trials. Most of
these purchase obligations are
cancelable.
|
Net
Operating Loss Carryforwards
At
December 31, 2008, we had United States federal and state net operating loss
carryforwards of $91.4 million and $56.9 million, respectively, available to
offset against future taxable income, which expire in 2011 through 2028. As a
result of a change in-control that occurred in our shareholder base in July
2002, approximately $47.5 million in federal net operating loss
carryforwards
39
became
limited in their availability to $0.3 million annually. Management currently
believes that the remaining $43.9 million in federal net operating loss
carryforwards, and the $56.3 million in state net operating loss carryforwards,
are unrestricted. However, we are reviewing our recent equity transactions to
determine if they may have resulted in any further restrictions on our net
operating loss carryforwards. Additionally, due to the change-in-control,
approximately $6.3 million of research and development tax credits will not be
available for utilization and were written off. As of December 31, 2008, we also
had research and development and alternative minimum tax credits for federal and
state purposes of approximately $3.9 million and $3.1 million, respectively,
available for offset against future income taxes, which expire in 2023 through
2028. 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 income tax
valuation allowance has been recorded against these assets.
Results
of Operations
We
recorded net losses of $27.0 million, $21.9 million and $16.8 million during the
years ended December 31, 2008, 2007 and 2006, respectively.
During
fiscal 2008, we recognized $6.2 million in service revenues relating to our
$24.3 million sale to the ALSCRT of a one-percent royalty interest in the
worldwide sales of arimoclomol in August 2006. This compares to $7.2 million and
$1.9 million in service revenues in the years ended December 31, 2007 and 2006,
respectively. During 2008, 2007 and 2006, we earned an immaterial amount of
license fees and grant revenue. All future licensing fees under our current
licensing agreements are dependent upon successful development milestones being
achieved by the licensor. During fiscal 2009, we are not anticipating the
receipt of any significant service or licensing fees, although we estimate that
we will recognize an additional $1.8 million in service revenues from that
arimoclomol royalty transaction. We will continue to recognize the balance of
the deferred revenue recorded from the royalty transaction with the ALS
Charitable Remainder Trust based on actual research and development costs
incurred over the development period of our arimoclomol research.
Research
and Development
Years Ended December 31,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
(In
thousands)
|
||||||||||||
Research
and development expense
|
$ | 9,913 | $ | 14,454 | $ | 8,858 | ||||||
Non-cash
research and development expense
|
(224 | ) | 3,778 | 674 | ||||||||
Employee
stock option expense
|
777 | 592 | 249 | |||||||||
$ | 10,466 | $ | 18,824 | $ | 9,781 |
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.
Research
and development expenses incurred during 2008, 2007 and 2006 relate
to our various development programs. In 2008, only the months of January and
February included RXi-related expenses (totaling approximately $0.6 million),
which accounts for the significant decrease in research and development
expenses, and non-cash research and development expenses. In the 2008 year, our
development costs associated with our Phase II clinical program for
arimoclomol in ALS were $3.5 million, the costs of our program for
arimoclomol in stroke recovery and related studies were $0.7 million, the costs
of our program for iroxanadine for diabetic complications were $1.4 million, the
costs of operating our development programs were $0.9 million, and the cost of
operations in our research laboratory were $2.1 million.
In September, 2008, CytRx acquired clinical-stage oncology product
candidates including tamibarotene from Innovive Pharmaceuticals, Inc. and our
development costs associated with the Innovive compounds were $1.5
million. None of our research and development costs have
ever been capitalized.
As
compensation to scientific advisory board (“SAB”) members and consultants, and
in connection with the acquisition of technology, we and RXi sometimes issue
shares of common stock, stock options and warrants to purchase shares of common
stock. 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 a recovery of $0.2 million resulting from the
application of marked to market accounting of the value of the non-employee
option grants in 2008, and charges of $3.8 million and $0.7 million in this
regard during 2007 and 2006, respectively. Included in the
40
research
and development charges for 2007 were $2.3 million of expense related to RXi’s
issuance of 462,112 shares of common stock to UMMS for certain license agreement
rights and a new invention disclosure agreement and $1.0 million for
non-qualifying stock options to SAB members of RXi. In 2008, we recorded $0.8
million of employee stock option expense as compared to $0.6 million in 2007 and
$0.2 million in 2006.
We also
incurred an expenditure of $8.0 million in 2008 related to the acquisition of
Innovive’s in-process research and development, which has been reflected as a
separate line item on our Consolidated Statements of Operations.
In 2008,
we expect our research and development expenses to increase as a result of our
clinical programs with tamibarotene and INNO-206.
General
and administrative expenses
Years Ended December 31,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
(In
thousands)
|
||||||||||||
General
and administrative expenses
|
$ | 9,134 | $ | 12,666 | $ | 8,622 | ||||||
Stock,
stock option and warrant expenses to non-employees and
consultants
|
189 | 2 | 60 | |||||||||
Employee
stock option expense
|
1,610 | 2,154 | 975 | |||||||||
$ | 10,933 | $ | 14,822 | $ | 9,657 |
General
and administrative expenses include all administrative salaries and general
corporate expenses, including legal expenses associated with the prosecution of
our intellectual property. Our general and administrative expenses, excluding
common stock, stock options and warrants issued, and excluding depreciation
expense, were $9.1 million in 2008, $12.7 million in 2007 and $8.6 million in
2006. General and administrative expenses in 2007 included $4.6 million of
RXi-related expenses, whereas, in 2008, the RXi-related expenses for January and
February totaled $1.3 million. The general and administrative expenses in 2008,
excluding RXi-related expenses, increased by $100,000 as compared to 2007. This
increase is a net result of an increase in legal and professional fees of
approximately $320,000, primarily due to costs associated with the acquisition
of Innovive, offset by a reduction of $300,000 in legal and accounting fees as
compared to 2007, primarily due to the costs associated with the spin-off of RXi
in 2007.
From time
to time, we issue shares of our common stock or warrants or options to purchase
shares of 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 we
can measure more reliably.
Since our
adoption of SFAS 123(R) in 2006, we recorded employee stock option expense of
$1.6 million in fiscal 2008, $2.2 million in fiscal 2007 and $1.0 million in
2006. The increase in 2007 over both 2008 and 2006 primarily related to stock
options granted by RXi to recruit and retain directors, officers and additional
employees.
Depreciation
and amortization
Depreciation
and amortization expenses were $625,000, $272,000 and $228,000 in 2008, 2007 and
2006, respectively. The depreciation expense reflects the depreciation of our
fixed assets and the amortization expenses related to our molecular
library.
Other
Income
In March
2008, we recognized a non-cash gain of $227,000 on the bonus paid to certain employees and
directors in RXi shares. In June 2007, we recognized $1.5 million of income
arising from a fee received pursuant to a change-in-control provision included
in the purchase agreement for our 1998 sale of its animal pharmaceutical
unit.
Interest
income
Interest
income was $1.2 million in 2008, $2.7 million in 2007 and $1.0 million in 2006.
The variances between years are attributable primarily to the amount of funds
available for investment each year and, to a lesser extent, changes in
prevailing market rates.
41
Minority
interest in losses of subsidiary
We offset
$88,000 of minority interest in losses of RXi against our net loss for the
months of January and February 2008. For the remainder of the year, RXi’s gain
and losses were accounted for under the equity method, because we owned less
than 50% of RXi following our March 11, 2008 distribution to our
stockholders of RXi shares. We offset $449,000 of minority interest in losses of
RXi against our net loss for the year ended December 31, 2007.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
(“SFAS”) No. 157, Fair Value
Measurements (“SFAS No. 157”). SFAS No. 157 defines fair value,
establishes a framework for measuring fair value in accordance with generally
accepted accounting principles, and expands disclosures about fair value
measurements. SFAS No. 157 does not expand the use of fair value in any new
circumstances. In February 2008, the FASB issued Staff Position No. FAS 157-1,
which amended SFAS No. 157 to exclude SFAS No. 13, Accounting for Leases, and
other accounting pronouncements that address fair value measurements for
purposes of lease classification or measurement under Statement 13. However,
this scope exception does not apply to assets acquired and liabilities assumed
in a business combination. Also in February 2008, the FASB issued Staff Position
No. FAS 157-2, which delayed the effective date of SFAS No. 157 for
non-financial assets and liabilities, except those items recognized at fair
value on an annual or more frequently recurring basis to fiscal years beginning
after November 15, 2008 and interim periods within those fiscal years. In
October, 2008 the FASB issued Staff Position No. FAS 157-3 which clarified the
application of SFAS No. 157 in a market that is not
active. We adopted SFAS No. 157 with no material impact on our consolidated
financial statements.
In
February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and Financial
Liabilities (“SFAS No. 159”). SFAS No. 159 permits entities to choose to
measure many financial assets and financial liabilities at fair value.
Unrealized gains and losses on items for which the fair value option has been
elected are reported in earnings. SFAS No. 159 is effective for fiscal years
beginning after November 15, 2007. The adoption of SFAS No. 159 will not have a
significant impact on our consolidated financial statements.
In June
2007, the FASB ratified the consensus on Emerging Issues Task Force (“EITF”)
Issue No. 06-11, Accounting
for Income Tax Benefits of Dividends on Share-Based Payment Awards
(“EITF 06-11”). EITF 06-11 requires companies to recognize the income tax
benefit realized from dividends or dividend equivalents that are charged to
retained earnings and paid to employees for non-vested equity-classified
employee share-based payment awards as an increase to additional paid-in
capital. EITF 06-11 is effective for fiscal years beginning after September 15,
2007. The adoption did not have a significant impact on our consolidated
financial statements.
In June
2007, the FASB ratified the consensus reached on EITF Issue No. 07-3, Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities (“EITF 07-3”), which requires that
nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities be deferred and
amortized over the period that the goods are delivered or the related services
are performed, subject to an assessment of recoverability. EITF 07-3 will be
effective for fiscal years beginning after December 15, 2007. The adoption of
EITF 07-3 did not have an impact on our consolidated financial
statements.
In
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests
in Consolidated Financial
Statements (“SFAS No. 160”) and a revision to SFAS No. 141, Business Combinations (“SFAS
No. 141R”). SFAS No. 160 modifies the accounting for noncontrolling interest in
a subsidiary and the deconsolidation of a subsidiary. SFAS No. 141R establishes
the measurements in a business combination of the identifiable assets acquired,
the liabilities assumed and any noncontrolling interest in the acquiree. Both of
these related statements are effective for fiscal years beginning after December
15, 2008. We have not yet determined the impact that the recent adoption of
these two statements may have on our consolidated financial
statements.
In
December 2007, the SEC issued Staff Accounting Bulletin 110 (“SAB 110”), which
expresses the views of the Staff regarding use of a “simplified” method, as
discussed in SAB 107, in developing an estimate of expected term of “plain
vanilla” share options in accordance with Statement of Financial Accounting
Standards No. 123. SAB 110 will allow, under certain circumstances, the use of
the simplified method beyond December 31, 2007 when a Company is unable to rely
on the historical exercise data. The adoption of SAB 110 did not have a material
impact on our financial statements.
In March
2008, the FASB issued Statement of Financial Accounting Standards No. 161, Disclosures about Derivative
Instruments and Hedging Activities (“SFAS No. 161”). The new
standard amends Statement of Financial Accounting Standards No.
42
133,
Accounting for Derivative
Instruments and Hedging Activities (“SFAS 133”), and seeks to enhance
disclosure about how and why a company uses derivatives; how derivative
instruments are accounted for under SFAS 133 (and the interpretations of that
standard); and how derivatives affect a company’s financial position, financial
performance and cash flows. SFAS 161 will be effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008. Early application of the standard is encouraged, as well as
comparative disclosures for earlier periods at initial adoption. The
Company does not believe adoption of this standard will have a material effect
on its financial statements.
In April
2008, the FASB issued Staff Position No. FAS 142-3, Determination of the Useful Life of
Intangible Assets, which amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of
a recognized intangible asset under FASB Statement No. 142, “Goodwill and Other Intangible
Assets.” The Position will be effective for fiscal years
beginning after December 15, 2008 and will only apply prospectively to
intangible assets acquired after the effective date. Early adoption
is not permitted. The Company does not believe adoption of this standard will
have a material effect on its financial statements.
In May
2008, the FASB issued Staff Position No. Accounting Principles Board 14-1, Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement) (“FSP No. APB 14-1”). FSP No. APB 14-1 requires
that the liability and equity components of convertible debt instruments that
may be settled in cash upon conversion (including partial cash settlement) be
separately accounted for in a manner that reflects an issuer’s nonconvertible
debt borrowing rate. FSP No. APB 14-1 will be effective for us as of
January 1, 2009. The Company does not believe adoption of this
principle will have a material effect on its financial statements.
In May
2008, the FASB issued Statement of Financial Accounting Standards No.
162, The Hierarchy of
Generally Accepted Accounting Principles, (“SFAS 162”), which imposes the
GAAP hierarchy on the reporting entities, not their auditors, based on the
long-standing mandate that the entity's management, not their auditors, is
responsible for selecting and applying the appropriate GAAP to their financial
statements. The auditors' responsibility is to comply with GAAS as a basis for
issuing their audit opinion. In issuing SFAS 162, the FASB does not expect a
change in current practice and The Company does not believe adoption of this
standard will have any impact on its financial statements.
In August
2008, the U.S. Securities and Exchange Commission, or SEC, announced that it
will issue for comment a proposed roadmap regarding the potential use by U.S.
issuers of financial statements prepared in accordance with International
Financial Reporting Standards, or IFRS. IFRS is a comprehensive series of
accounting standards published by the International Accounting Standards Board,
or IASB. Under the proposed roadmap, the Company could be required in fiscal
year 2014 to prepare financial statements in accordance with IFRS and the SEC
will make a determination in 2011 regarding mandatory adoption of IFRS. The
Company is currently assessing the impact that this potential change would have
on our consolidated financial statements and will continue to monitor the
development of the potential implementation of IFRS.
Off-Balance
Sheet Arrangements
We have
not entered into off-balance sheet financing arrangements, other than operating
leases.
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 U.S. 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. 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. If interest
rates had varied by 10% in the year ended December 31, 2008, it would not have
had a material effect on our results of operations or cash flows for that
period.
Item
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA
Our
consolidated financial statements and supplemental schedule and notes thereto as
of December 31, 2008 and 2007, and for each of the three years in the period
then ended December 31, 2008, 2007 and 2006, together with the independent
registered public accounting firms’ reports thereon, are set forth on pages F-1
to F-25 of this Annual Report.
43
Item
9A. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that the
information disclosed in the reports we file with the Securities and Exchange
Commission under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange
Commission’s rules and forms, and that such information is accumulated and
communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure.
Our
management, with the participation of our Chief Executive Officer and Chief
Financial Officer, performed an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in
Securities Exchange Act Rule 13a-15(e)) as of the end of the period covered by
this Annual 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, 2008 to provide reasonable
assurance that information required to be disclosed by us in reports that we
file or submit under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the time periods specified in the Securities and
Exchange Commission’s rules and forms.
There was
no change in our internal control over financial reporting that occurred during
the quarter ended December 31, 2008 that materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting. Our internal control over financial reporting
is a process designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of the consolidated financial
statements and related disclosures in accordance with generally accepted
accounting principles. Our internal control over financial reporting includes
those policies and procedures that (1) pertain to the maintenance of records
that, in reasonable detail, accurately and fairly reflect the transactions of
our company; (2) provide reasonable assurance that transactions are recorded as
necessary to permit preparation of the consolidated financial statements and
related disclosures in accordance with generally accepted accounting principles
and that our receipts and expenditures are being made only in accordance with
authorizations of our management and directors; and (3) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition,
use, or disposition of our assets that could have a material effect on our
consolidated financial statements and related disclosures.
Because
of inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with policies and procedures may deteriorate.
We
assessed the effectiveness of our internal control over financial reporting as
of December 31, 2008. In making this assessment, management used the criteria
set forth by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”) in Internal Control-Integrated
Framework.
Based
upon management’s assessment using the criteria contained in COSO, our
management has concluded that, as of December 31, 2008, our internal control
over financial reporting was effective.
We
continuously seek to improve and strengthen our control processes to ensure that
all of our controls and procedures are adequate and effective. Any failure to
implement and maintain improvements in the controls over our financial reporting
could cause us to fail to meet our reporting obligations under the Securities
and Exchange Commission’s rules and regulations. Any failure to improve our
internal controls to address the weaknesses we have identified could also cause
investors to lose confidence in our reported financial information, which could
have a negative impact on the trading price of our common stock.
44
PART
III
Item
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE
The
following table sets forth information concerning our directors and executive
officers:
Name
|
Age
|
Class
of
Director(1)
|
Position
|
|||
Max
Link, Ph.D.
|
68
|
III
|
Director,
Chairman of the Board(2)(3)(4)
|
|||
Steven
A. Kriegsman
|
67
|
II
|
Director,
Chief Executive Officer, President
|
|||
Marvin
R. Selter
|
81
|
II
|
Director,
Vice Chairman of the Board(2)(3)(4)
|
|||
Louis
Ignarro, Ph.D.
|
67
|
I
|
Director
|
|||
Joseph
Rubinfeld, Ph.D.
|
76
|
I
|
Director
|
|||
Richard
L. Wennekamp
|
66
|
II
|
Director(2)(3)(4)
|
|||
John
Y. Caloz
|
57
|
—
|
Chief
Financial Officer, Treasurer
|
|||
Jack
R. Barber, Ph.D.
|
53
|
—
|
Chief
Scientific Officer
|
|||
Shi
Chung Ng, Ph.D.
|
54
|
—
|
Senior
Vice President — Research and Development
|
|||
Scott
Wieland
|
49
|
—
|
Senior
Vice President — Drug Development
|
|||
Benjamin
S. Levin
|
33
|
—
|
General
Counsel, Vice President — Legal Affairs and Corporate
Secretary
|
____________
(1)
|
Our
Class III director serves until the 2009 annual meeting of stockholders,
our Class I directors serve until the 2010 annual meeting of stockholders,
and our Class II directors serve until the 2011 annual meeting of
stockholders.
|
(2)
|
Members
of our Audit Committee. Mr. Selter is the Chairman of the
Committee.
|
(3)
|
Members
of our Nominating and Corporate Governance Committee. Mr. Wennekamp is
Chairman of the Committee.
|
(4)
|
Members
of our Compensation Committee. Mr. Wennekamp is Chairman of the
committee.
|
Max Link, Ph.D has been a
director since 1996. Dr. Link has been retired from business since 2003. From
March 2002 until its acquisition by Zimmer Holdings, Dr. Link served as Chairman
and CEO of Centerpulse, Ltd. From May 1993 to June 1994, Dr. Link served as the
Chief Executive Officer of Corange Ltd. (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 U.S. operations of Sandoz, including President and
Chief Executive Officer. Dr. Link also serves as a director of Alexion
Pharmaceuticals, Inc., Celsion Corporation and Discovery Laboratories,
Inc.
Steven A. Kriegsman has been
a director and our President and Chief Executive Officer since July 2002. He
also serves as a director of our 45% owned affiliate, RXi Pharmaceuticals
Corporation. He also serves as a director of Hythiam Corporation. He
previously served as Director and Chairman of Global Genomics from June 2000.
Mr. Kriegsman is an inactive 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 in the healthcare
industry. He has advised such companies as SuperGen Inc., Closure Medical
Corporation, Novoste Corporation, Miravant Medical Technologies, and Maxim
Pharmaceuticals. Mr. Kriegsman has a BS degree with honors from New York
University in Accounting and completed the Executive Program in Mergers and
Acquisitions at New York University, The Management Institute. Mr. Kriegsman was
formerly a Certified Public Accountant with KPMG in New York City. He serves as
a Director and is the former Chairman of the Audit Committee of Bradley
Pharmaceuticals, Inc. In February 2006, Mr. Kriegsman received the Corporate
Philanthropist of the Year Award from the Greater Los Angeles Chapter of the ALS
Association and in October 2006, he received the Lou Gehrig Memorial Corporate
Award from the Muscular Dystrophy Association. Mr. Kriegsman has been active in
various charitable organizations including the Biotechnology Industry
Organization, the ALS Association, the Los Angeles Venture Association, the
Southern California Biomedical Council, and the Palisades-Malibu
YMCA.
Marvin R. Selter has been a
director since October 2003. He has been President and Chief Executive Officer
of CMS, Inc. since he founded that firm in 1968. CMS, Inc. is a national
management consulting firm. In 1972, Mr. Selter originated the concept of
employee leasing. He served as a member of the Business Tax Advisory
Committee—City of Los Angeles, Small Business Board—State of California and the
Small Business Advisory Commission—State of California. Mr. Selter also serves
on the Valley Economic Development Center as past Chairman and Audit Committee
Chairman, the Board of Valley Industry and Commerce Association as
45
past Chairman, the Advisory Board of the San Fernando Economic
Alliance and the California State University—Northridge as Past Chairman of the
Economic Research Center and President of the Olive View UCLA Medical
Center Foundation. 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—The State University, majoring
in Accounting and Business Administration. He was an LPA having served as
Controller, Financial Vice President and Treasurer at distribution,
manufacturing and service firms. He has lectured extensively on finance,
corporate structure and budgeting for the American Management Association and
other professional teaching associations.
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. Belzer,
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, and has served as our Chief Scientific Advisor
since December 2008 pursuant to a consulting agreement with Dr. Rubinfeld
described in the “Certain Relationships and Related Transactions” section of the
Annual Report. 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
February 8, 2005. Dr. Rubinfeld was also Chief Scientific Officer of SuperGen
from 1991 until September 1997. 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 retired from Community Bank in June 2008 where
he was the Senior Vice President-Credit Administration 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 U.S., Gerald R. Ford, and the Executive Director of the
Ford Transition Office. Prior thereto, he served as Staff Assistant to the
President of the U.S. for one year, and as the Special Assistant to the
Assistant Secretary of Commerce of the U.S.
John Y. Caloz joined CytRx as
our Chief Accounting Officer in October, 2007. In January of 2009 Mr.
Caloz was named Chief Financial Officer. He has a history of providing senior
financial leadership in the life sciences sector, as Chief Financial Officer of
Occulogix, Inc, a NASDAQ listed, a medical therapy company. Prior to that, Mr.
Caloz served as Chief Financial Officer of IRIS International Inc., a
Chatsworth, CA based medical device manufacturer. He served as Chief Financial
Officer of San Francisco-based Synarc, Inc., a medial imaging company, and from
1993 to 1999 he was Senior Vice President, Finance and Chief Financial Officer
of Phoenix International Life Sciences Inc. of Montreal, Canada, which was
acquired by MDS Inc. in 1999. Mr. Caloz was a partner at Rooney, Greig, Whitrod,
Filion & Associates of Saint Laurent, Quebec, Canada, a firm of Chartered
Accountants specializing in research and development and high tech companies,
from 1983 to 1993. Mr. Caloz, a Chartered Accountant, holds a degree in
Accounting from York University, Toronto, Canada,
Jack R. Barber, Ph.D. has
been our Senior Vice President - Drug Development since July 2004, and was named
Chief Scientific Officer in February 2007. 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.
Shi Chung Ng, Ph.D. joined
CytRx as our Senior Vice President, Research and Development in April 2008.
Previously, he served as Vice President of Molecular Oncology at Ligand
Pharmaceuticals, directing the cancer discovery efforts as well as genomics
biomarker studies for Targretin. Prior to that, he served as Vice President of
Drug Discovery Biology and Preclinical Development of ArQule, Inc., leading
novel cell cycle checkpoint activation drug discovery and development efforts
for ARQ-197. From 1993-2004, Dr. Ng co-led efforts in the discovery and
development of multiple oncology drug candidates at Abbott, including a Bcl-2
inhibitor, farnesyl transferase inhibitors, and novel anti-mitotics as a
founding member of Abbott oncology, a Senior Group Leader and a Volwiler
Associate Fellow. Prior to his tenure at Abbott, Dr. Ng worked at Pfizer,
Bristol-Myers Squibb and Harvard Medical School. He was adjunct Assistant
Professor at the Chicago Medical School, and adjunct Faculty Member at
Northwestern University. He had
46
also
served as a visiting Professor at Rutgers University, a visiting Research Staff
Member at Princeton University, and an Instructor in Medicine at Harvard Medical
School. Dr. Ng received a Ph.D. in Biochemistry from Purdue University, and
a Postdoctoral Fellowship from Howard Hughes Medical Institute and Harvard
Medical School. Dr. Ng has published over 200 papers, abstracts and patent
applications and he was the recipient of multiple scholarships and
awards.
Scott Wieland, Ph.D, joined
CytRx in 2005 as the Vice President – Clinical and Regulatory Affairs and was
promoted to the position of Senior Vice President – Drug Development in December
2008. Prior to that, he served in senior level positions in the areas of Drug
Development, Clinical and Regulatory Affairs at various biotech firms. He spent
five years at NeoTherapeutics, Inc. serving as the Director of Product
Development and was later promoted to Vice President of Product Development.
From 1990 to 1997, he served as Director of Regulatory Affairs at CoCensys,
Inc. Dr. Wieland has a Ph.D. in Biopsychology and an M.A. in
Psychology from the University of Arizona. He has an MBA from Webster
University. Dr. Wieland received his B.S. in Physiological Psychology from the
University of California, Santa Barbara.
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 O’Melveny & Myers
LLP. Mr. Levin received his S.B. in Economics from the Massachusetts Institute
of Technology, and a J.D. from Stanford Law School.
Audit
Committee
Our board
of directors has a standing Audit Committee currently composed of Messrs.
Selter, Link, and Wennekamp. Dr. Rubinfeld served on our Audit Committee until
October 30, 2008. Our board of directors has determined that Mr.
Selter, one of the independent directors serving on our Audit Committee, is an
“audit committee financial expert” as defined by the SEC’s rules. Our board of
directors has determined that Messrs. Link, Selter and Wennekamp are
“independent” under the current independence standards of both The NASDAQ
Capital Market and the SEC.
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 under 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 our directors and executive officers and greater than 10% shareholders for
2007 complied with all applicable Section 16(a) filing
requirements.
Code
of Ethics
We have
adopted a Code of Ethics applicable to all employees, including our principal
executive officer, principal financial officer, and principal accounting officer
or controller, a copy of which is available on our website at www.cytrx.com. We
will furnish, without charge, a copy of our Code of Ethics upon request. Such
requests should be directed to Attention: Corporate Secretary, 11726 San Vicente
Boulevard, Suite 650, Los Angeles, California, or by telephone at
310-826-5648.
Item
11. EXECUTIVE COMPENSATION
Compensation
Discussion and Analysis
Overview
of Executive Compensation Program
The
Compensation Committee of our board of directors has responsibility for
establishing, implementing and monitoring our executive compensation program
philosophy and practices. The Compensation Committee seeks to ensure that the
total compensation paid to our named executive officers is fair, reasonable and
competitive. Generally, the types of compensation and benefits provided to the
named executive officers are similar to those provided to our other
officers.
Throughout
this Annual Report, the individuals included in the Summary Compensation Table
on page 53 are referred to as the “named executive officers.”
47
Compensation
Philosophy and Objectives
The
components of our executive compensation consist of salary, annual cash bonuses
awarded based on the Compensation Committee’s subjective assessment of each
individual executive’s job performance, including evaluations of, during the
past year, stock option grants to provide executives with longer-term
incentives, and occasional special compensation awards (either cash, stock or
stock options) to reward extraordinary efforts or results.
The
Compensation Committee believes that an effective executive compensation program
should provide base annual compensation that is reasonable in relation to
individual executive’s job responsibilities and reward the achievement of both
annual and long-term strategic goals of our company. The Compensation Committee
uses annual and other periodic cash bonuses to reward an officer’s achievement
of specific goals, including goals related to the development of the product’s
drug candidates and management of working capital, and employee stock options as
a retention tool and as a means to align the executive’s long-term interests
with those of our stockholders, with the ultimate objective of affording our
executives an appropriate incentive to improve stockholder value. The
Compensation Committee evaluates both performance and compensation to maintain
our company’s ability to attract and retain excellent employees in key positions
and to assure that compensation provided to key employees remains competitive
relative to the compensation paid to similarly situated executives of comparable
companies. To that end, the Compensation Committee believes executive
compensation packages provided by us to our named executive officers should
include both cash compensation and stock options.
Because
of the size of our company, the small number of executive officers in our
company, and our company’s financial priorities, the Compensation Committee has
not implemented any pension benefits, deferred compensation plans, or other
similar plans for our named executive officers.
As a
biopharmaceutical company engaged in developing potential products that, to
date, have not generated significant revenues and are not expected to generate
significant revenues or profits for several years, the Compensation Committee
also takes the company’s financial and working capital condition into account in
its compensation decisions. Accordingly, the Compensation Committee recently has
weighted bonuses more heavily with stock options rather than cash. The
Compensation Committee may periodically reassess the proper weighting of equity
and cash compensation in light of the company’s working capital situation from
time to time.
Role
of Executive Officers in Compensation Decisions
The
Compensation Committee makes all compensation decisions for the named executive
officers and approves recommendations made by our President and Chief Executive
Officer regarding equity awards to our other officers. Decisions regarding the
non-equity compensation of our other officers are made by our President and
Chief Executive Officer.
The
Compensation Committee and the President and Chief Executive Officer annually
review the performance of each named executive officer (other than the President
and Chief Executive Officer, whose performance is reviewed only by the
Compensation Committee). The conclusions reached and recommendations based on
these reviews, including with respect to salary adjustments and annual award
amounts, are presented to the Compensation Committee. The Compensation Committee
can exercise its discretion in modifying or declining any recommended
adjustments or awards to executives.
Setting
Executive Compensation
Based on
the foregoing objectives, the Compensation Committee has structured the
company’s annual cash and incentive-based cash and non-cash executive
compensation to seek to motivate our named executives to achieve the company’s
business goals, including goals related to the development of the our drug
candidates and management of working capital, to reward the executives for
achieving such goals, and to retain the executives. In doing so, the
Compensation Committee historically has not employed outside compensation
consultants. However, during 2008, the Compensation Committee obtained two
third-party industry compensation surveys and used them in its compensation
deliberations regarding cash and equity compensation for our executive officers.
The Compensation
Committee utilized this data to set compensation for our executive officers at
levels targeted at or around the third quartile of compensation amounts provided
to executives at comparable companies considering each individual’s individual
experience level related to their position with us. There is no pre-established
policy or target for the allocation between either cash and non-cash incentive
compensation.
48
2008
Executive Compensation Components
For 2008,
the principal components of compensation for the named executive officers
were:
·
|
base
salary;
|
·
|
annual
and special bonuses; and
|
·
|
equity
incentive compensation.
|
Base
Salary
The
Company provides named executive officers and other employees with base salary
to compensate them for services rendered during the year. Base salary ranges for
the named executive officers are determined for each named executive officer
based on his position and responsibility.
During
its review of base salaries for executives, the Compensation Committee primarily
considers:
·
|
the
negotiated terms of each executive’s employment agreement, if
any;
|
·
|
an
internal review of the executive’s compensation, both individually and
relative to other named executive
officers;
|
·
|
each
executive’s individual performance;
and
|
·
|
base
salaries paid by comparable
companies.
|
Salary
levels are typically considered annually as part of the company’s performance
review process, as well as upon a change in job responsibility. Merit-based
increases to salaries are based on the company’s available resources and the
Compensation Committee’s assessment of the individual’s performance. Both
assessments are based upon written evaluations of such criteria as job
knowledge, communication, problem solving, initiative, goal-setting, and expense
management. As a result of the Company’s working capital position at the end of
2008, the Compensation Committee and the company’s named executive officers
agreed that base salaries would remain unchanged in 2009, except in
circumstances where named executive officers assumed new positions with the
company. As described in the “Employment Agreements and Potential
Payment Upon Termination or Change in Control” section of this Annual Report, we
have entered into new employment agreements with each of the named executive
officers (other than Mr. Kriegsman) that continue their 2008 base salaries in
effect until the expiration of their employment agreements on December 31,
2009.
Annual
and Special Bonuses
The
Compensation Committee has not established an incentive compensation program
with fixed performance targets. Because we do not generate significant revenues
and have not commercially released any products, the Compensation Committee
bases its discretionary compensation awards on the achievement of product
development targets and milestones, efforts related to extraordinary
transactions, effective fund-raising efforts, and effective management of
personnel and capital resources, among other criteria. During 2008, the
Compensation Committee granted Mr. Kriegsman an annual cash bonus of $150,000,
the minimum bonus guaranteed to Mr. Kriegsman under his employment agreement,
and granted cash bonuses to the other named executive officers ranging from
$38,250 to $55,000, each in conjunction with the end of their employment
contract years, principally based on their efforts in helping us advance the
development of our products, complete the partial spin-off of RXi, and acquire
Innovive and achieve other corporate goals.
On March
11, 2008, the record date for our recent distribution of RXi shares to our
stockholders, we awarded approximately 27,700 shares of RXi to our directors,
officers and other employees, including the named executive officers, in
connection with our separation from RXi to compensate those directors, officers
and other employees for services performed in connection with the separation.
Each of our directors, officers and other employees who held stock options to
purchase our common stock received that number of RXi shares that such
individual would have received in the separation, assuming such individual had,
on the record date for the separation, exercised, in full, on a “net-exercise”
basis, all such stock options to the extent then exercisable.
49
Equity
Incentive Compensation
As
indicated above, the Compensation Committee also aims to encourage the company’s
executive officers to focus on long-term company performance by allocating to
them stock options that vest over a period of several years. In 2008, the
Compensation Committee granted to Mr. Kriegsman nonqualified options to purchase
450,000 shares of our common stock at a price of $1.21 per share and 300,000
shares of our common stock at a price of $0.37 per share, which equaled the
closing market price on the respective dates of grant. The option vests monthly
over three years, provided that Mr. Kriegsman continues in our employ through
such monthly vesting periods. In addition, in connection with the annual review
of our other named executive officers, the Compensation Committee also granted
stock options to those named executive officers. All of these other stock
options had an exercise price equal to the closing market price on the date of
grant, and also vest monthly over three years, provided that such executives
remain in our employ through such monthly vesting periods.
Retirement
Plans, Perquisites and Other Personal Benefits
We have
adopted a tax-qualified employee savings and retirement plan, the 401(k) Plan,
for eligible U.S. employees, including our named executive officers. Eligible
employees may elect to defer a percentage of their eligible compensation in the
401(k) Plan, subject to the statutorily prescribed annual limit. We may make
matching contributions on behalf of all participants in the 401(k) Plan in an
amount determined by our board of directors. We did not make any matching
contribution to the 401(k) Plan for 2008. Matching and
profit-sharing contributions, if any, are subject to a vesting schedule; all
other contributions are at all times fully vested. We intend the 401(k) Plan,
and the accompanying trust, to qualify under Sections 401(k) and 501 of the
Internal Revenue Code so that contributions by employees to the 401(k) Plan, and
income earned (if any) on plan contributions, are not taxable to employees until
withdrawn from the 401(k) Plan, and so that we will be able to deduct our
contributions, if any, when made. The trustee under the 401(k) Plan, at the
direction of each participant, may invest the assets of the 401(k) Plan in any
of a number of investment options.
We do not
provide any of our executive officers with any other perquisites or personal
benefits, other than benefits to Mr. Kriegsman provided for in his
employment agreement. As required by his employment agreement, during 2008 we
paid insurance premiums with respect to a life insurance policy for Mr.
Kriegsman which had a face value of approximately $1.4 million as of December
31, 2008 and under which Mr. Kriegsman’s designee is the
beneficiary.
Employment
Agreements and Severance Arrangements
We have
entered into written employment agreements with each of our named executive
officers. The main purpose of these agreements is to protect the company from
business risks such as competition for the executives’ service, loss of
confidentiality or trade secrets, and solicitation of our other employees, and
to define our right to terminate the employment relationship. The employment
agreements also protect the executive from termination without “cause” (as
defined) and, in Mr. Kriegsman’s case, entitles him to resign for “good reason”
(as defined). Each employment agreement was individually negotiated, so there
are some minor variations in the terms among executive officers. Generally
speaking, however, the employment agreements provide for termination and
severance benefits that the Compensation Committee believes are consistent with
industry practices for similarly situated executives. The Compensation Committee
believes that the termination and severance benefits help the company retain the
named executive officers by providing them with a competitive employment
arrangement and protection against unknowns such as termination without “cause”
that go along with the position.
In the
event of termination without “cause,” the named executive officers will be
entitled to a lump-sum payment equal to six months of base salary (24 months in
the case of Mr. Kriegsman). Mr. Kriegsman’s employment agreement also provides
for our continuation of Mr. Kriegsman’s life insurance and medical benefits
during his 24-month severance period. If Mr. Kriegsman’s employment is
terminated by us without “cause,” or by Mr. Kriegsman for “good reason,” within
two years following a change of control of CytRx, he also would be entitled
under his employment agreement to receive a “gross-up” payment equal to the sum
of any excise tax on his termination benefits (including any accelerated vesting
of his options under our Plans as described below) plus any penalties and
interest.
Change
of Control Arrangements
The
company’s 2000 Long-Term Incentive Plan and 2008 Stock Incentive Plan provide
generally that, upon a change of control of CytRx, all unvested stock options
and awards under the Plans held by plan participants, including the named
executive officers, will become immediately vested and exercisable immediately
prior to the effective date of the transaction. The Compensation
Committee
50
believes
that such “single trigger” change of control policy is consistent with the
objective of aligning the interests of the named executive officer’s and of the
company’s stockholders by allowing the executives to participate equally with
stockholders in the event of a change of control transaction.
The
foregoing severance and change of control arrangements, including the
quantification of the payment and benefits provided under these arrangements,
are described in more detail elsewhere in this Annual Report under the heading
“Executive Compensation – Potential Payments Upon Termination or Change of
Control.”
Ownership
Guidelines
The
Compensation Committee has no requirement that each named executive officer
maintain a minimum ownership interest in our company.
Our
long-term incentive compensation consists solely of periodic grants of stock
options to our named executive officers. The stock option program:
·
|
links
the creation of stockholder value with executive
compensation;
|
·
|
provides
increased equity ownership by
executives;
|
·
|
functions
as a retention tool, because of the vesting features included in all
options granted by the Compensation Committee;
and
|
·
|
maintains
competitive levels of total
compensation.
|
We
normally grant stock options to new executive officers when they join our
company based upon their position with us and their relevant prior experience.
The options granted by the Compensation Committee generally vest monthly over
the first three years of the ten-year option term. Vesting and exercise rights
cease upon termination of employment (or, in the case of exercise rights, 90
days thereafter), except in the case of death (subject to a one-year
limitation), disability or retirement. Prior to the exercise of an option, the
holder has no rights as a stockholder with respect to the shares subject to such
option, including voting rights and the right to receive dividends or dividend
equivalents. In addition to the initial option grants, our Compensation
Committee may grant additional options to retain our executives and reward, or
provide incentive for, the achievement of corporate goals and strong individual
performance. Our board of directors has granted our President and Chief
Executive Officer discretion to grant up to 100,000 options to employees upon
joining our company, and to make grants an additional “discretionary pool” of up
to 100,000 options during each annual employee review cycle. Options are granted
based on a combination of individual contributions to our company and on general
corporate achievements, which may include the attainment of product development
milestones (such as commencement and completion of clinical trials) and
attaining other annual corporate goals and objectives. On an annual basis, the
Compensation Committee assesses the appropriate individual and corporate goals
for our executives and provides additional option grants based upon the
achievement by the new executives of both individual and corporate goals. We
expect that we will continue to provide new employees with initial option grants
in the future to provide long-term compensation incentives and will continue to
rely on performance-based and retention grants to provide additional incentives
for current employees. Additionally, in the future, the Compensation Committee
may consider awarding additional or alternative forms of equity incentives, such
as grants of bonus stock, restricted stock and restricted stock
units.
It is our
policy to award stock options at an exercise price equal to The NASDAQ Capital
Market’s closing price of our common stock on the date of the grant. In certain
limited circumstances, the Compensation Committee may grant options to an
executive at an exercise price in excess of the closing price of the common
stock on the grant date. The Compensation Committee has never granted options
with an exercise price that is less than the closing price of our common stock
on the grant date, nor has it granted options which are priced on a date other
than the grant date. For purposes of determining the exercise price of stock
options, the grant date is deemed to be the first day of employment for newly
hired employees, or the date on which the Compensation Committee or the Chief
Executive Officer, as applicable, approves the stock option grant to existing
employees.
We have
no program, practice or plan to grant stock options to our executive officers,
including new executive officers, in coordination with the release of material
nonpublic information. We also have not timed the release of material nonpublic
information for the purpose of affecting the value of stock options or other
compensation to our executive officers, and we have no plan to do
so.
51
We have
no policy regarding the adjustment or recovery of stock option awards in
connection with the restatement of our financial statements, as our stock option
awards have not been tied to the achievement of specific financial
goals.
Tax
and Accounting Implications
Deductibility
of Executive Compensation
As part
of its role, the Compensation Committee reviews and considers the deductibility
of executive compensation under Section 162(m) of the Internal Revenue Code,
which provides that corporations may not deduct compensation of more than
$1,000,000 that is paid to certain individuals. We believe that compensation
paid to our executive officers generally is fully deductible for federal income
tax purposes.
Accounting
for Share-Based Compensation
Beginning
on January 1, 2006, we began accounting for share-based compensation in
accordance with the requirements of FASB Statement 123(R), Share-Based Payment. This
accounting treatment has not significantly affected our compensation decisions.
The Compensation Committee takes into consideration the tax consequences of
compensation to the named executive officers, but tax considerations are not a
significant part of the company’s compensation policy.
Benchmarking
The
Compensation Committee does not attempt to establish or measure executive
compensation against any benchmarks.
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 all served as members of the Compensation Committee during 2008. Dr.
Rubinfeld resigned as a member of the Committee in October 2008. He was replaced
by Max Link, Ph.D.
Compensation
Committee Report
The
Compensation Committee has reviewed and discussed with management the
“Compensation Discussion and Analysis” required by Item 402(b) of Regulation S-K
and, based on such review and discussions, has recommended to our board of
directors that the foregoing “Compensation Discussion and Analysis” be included
in this Annual Report.
Richard
L. Wennekamp, Chairman
|
Marvin
R. Selter
|
Dr.
Max Link
|
52
Summary
Compensation Table
The
following table presents summary information concerning all compensation paid or
accrued by us for services rendered in all capacities during 2008, 2007 and 2006
by Steven A. Kriegsman and Mitchell K. Fogelman, who are the only individuals
who served as our principal executive and financial officers during the year
ended December 31, 2008, and our three other most highly compensated executive
officers who were serving as executive officers as of December 31,
2008:
Summary
Compensation Table
Name and
Position
|
Year
|
Salary ($)
|
Bonus ($) (1)
|
Option Awards ($) (2)
|
All
Other
Compensation ($)(5)
|
Total ($)
|
|||||||||||
Steven
A. Kriegsman
|
|||||||||||||||||
President
and Chief Executive Officer
|
2008
|
551,000 | 150,000 | 105,328 | 10,000 | 816,328 | |||||||||||
2007
|
524,767
|
300,000 | 295,534 | — | 1,120,301 | ||||||||||||
2006
|
417,175
|
800,000 | 340,426 | — | 1,557,601 | ||||||||||||
Mitchell
K. Fogelman
|
|||||||||||||||||
Chief
Financial Officer and Treasurer (3)
|
2008
|
285,576 | 55,000 | 24,531 | — | 365,107 | |||||||||||
2007
|
76,763 | 100,000 | 35,665 | — | 212,428 | ||||||||||||
Jack
R. Barber, Ph.D.
|
|||||||||||||||||
Chief
Scientific Officer
|
2008
|
364,375 | 55,000 | 24,603 | — | 443,978 | |||||||||||
2007
|
327,074 | 125,000 | 168,876 | — | 620,950 | ||||||||||||
2006
|
261,750 | 218,750 | 90,544 | — | 571,044 | ||||||||||||
Benjamin
S. Levin General Counsel,
|
|||||||||||||||||
General
Counsel, Vice President —
|
2008
|
276,000 | 55,000 |
24,603
|
— | 355,603 | |||||||||||
LegalAffairs and
Secretary
|
2007
|
250,000 | 100,000 | 84,438 | — | 434,438 | |||||||||||
2006
|
208,170 | 219,750 |
120,550
|
— | 548,470 | ||||||||||||
Shi
Chung Ng, Ph.D.
|
|||||||||||||||||
Senior
Vice President – Research and
|
2008
|
275,000 | 41,250 | — | — | 316,250 | |||||||||||
Development (4)
|
2007
|
167,628 | — | — | — | 167,628 |
____________
(1)
|
Bonuses
to the named executive officers reported above relating to 2008 were paid
in December 2008. Bonuses to the named executive officers reported above
relating to 2007 were paid in April 2008. Bonuses to the named executive
officers reported above relating to 2006 were paid in both June 2006, in
connection with the contractual year end for those officers, and also in
April 2007, following our decision to determine and award bonuses in
connection with each fiscal year end. For purposes of this table, the
entire amount of the bonus paid as attributed to 2006 has been presented
as a 2006 amount.
|
(2)
|
The
values shown in this column represent the dollar amount recognized for
financial statement reporting purposes with respect to the 2006, 2007 and
2008 fiscal years for the fair value of stock options granted in 2006,
2007 and 2008 and prior fiscal years in accordance with SFAS 123(R).
Pursuant to SEC rules, the amounts shown exclude the impact of estimated
forfeitures related to service-based vesting conditions. The amount
recognized for these awards was calculated using the Black Scholes
option-pricing model, and reflect grants from our 2000 Long-Term Incentive
Plan, which is described in Note 13 of the Notes to Consolidated Financial
Statements.
|
(3)
|
Mr.
Fogelman served as our Chief Financial Officer and Treasurer from
September 11, 2007 through December 31, 2008, when he
resigned. On January 1, 2009, John Caloz was appointed to these
positions.
|
(4)
|
Dr.
Ng was hired on April 1, 2007.
|
(5)
This amount represents life insurance premiums.
53
2008
Grants of Plan-Based Awards
In 2008,
we granted stock options to our named executive officers under our 2000
Long-Term Incentive Plan as follows:
2008
Grants of Plan-Based Awards
Name
|
Grant Date
|
All
Other
Option
Awards
(#
of CytRx
Shares)
|
Exercise
Price of
Option
Awards
($/Share)
|
Grant
Date
Fair
Value of
Option
Awards
($)
|
||||||||||
Steven
A. Kriegsman
|
4/07/2008
|
450,000 | $ | 1.21 | $ | 425,700 | ||||||||
President
and Chief Executive Officer
|
11/21/2008
|
300,000 | 0.37 | 92,100 | ||||||||||
Mitchell
K. Fogelman (1)
|
4/07/2008
|
100,000 | $ | 1.21 | $ | 94,600 | ||||||||
Chief
Financial Officer and Treasurer
|
11/21/2008
|
100,000 | 0.37 | 30,700 | ||||||||||
Jack
R. Barber, Ph.D.
|
4/07/2008
|
100,000 | $ | 1.21 | $ | 94,600 | ||||||||
Chief
Scientific Officer
|
11/21/2008
|
100,000 | 0.37 | 30,700 | ||||||||||
Benjamin
S. Levin
|
4/07/2008
|
100,000 | $ | 1.21 | $ | 94,600 | ||||||||
General
Counsel, Vice President — Legal Affairs and Secretary
|
11/21/2008
|
100,000 | 0.37 | 30,700 | ||||||||||
Shi
Chung Ng, Ph.D.
|
11/21/2008
|
50,000 | $ | 0.37 | $ | 15,350 | ||||||||
Senior
Vice President – Research and Development
|
____________
|
(1)
Mr. Fogelman resigned from the company on December 31,
2008.
|
2000
Long-Term Incentive Plan
The
purpose of our 2000 Long-Term Incentive Plan is to promote our success and
enhance our value by linking the personal interests of our employees, officers,
consultants and directors to those of our stockholders, and by providing our
employees, officers, consultants and directors with an incentive for outstanding
performance. The Plan was originally adopted by our board of directors on August
24, 2000 and by our stockholders on June 7, 2001, with certain amendments to the
Plan having been subsequently approved by our board of directors and
stockholders.
The Plan
authorizes the granting of awards to our employees, officers, consultants and
directors and to employees, officers, consultants and directors of our
subsidiaries. The following awards are available under the Plan:
·
|
options
to purchase shares of common stock, which may be incentive stock options
or non-qualified stock options;
|
·
|
stock
appreciation rights;
|
·
|
restricted
stock;
|
·
|
performance
units;
|
·
|
dividend
equivalents; and
|
·
|
other
stock-based awards.
|
The
aggregate number of shares of our common stock reserved and available for awards
under the Plan is 10,000,000 shares. As of March 11, 2009, there were 7.1
million shares previously issued or subject to outstanding Plan awards and
approximately 0.7 million shares were available
for issuance pursuant to future awards under the Plan. The maximum number of
shares of common stock with respect to one or more options and stock
appreciation rights that we may grant during any one calendar year under the
Plan to any one participant is 1,000,000; except that in connection with his or
her initial employment with the company or an affiliate, a participant may be
granted options for up to an additional 1,000,000 shares. The maximum fair
market value of any awards that any
54
one
participant may receive during any one calendar year under the Plan is
$1,000,000, not including the value of options and stock appreciation rights
(less any consideration paid by the participant for such award).
Administration
The Plan
is administered by the Compensation Committee of our board of directors. The
Compensation Committee has the power, authority and discretion to:
·
|
designate
participants;
|
·
|
determine
the types of awards to grant to each participant and the number, terms and
conditions of any award;
|
·
|
establish,
adopt or revise any rules and regulations as it may deem necessary or
advisable to administer the Plan;
and
|
·
|
make
all other decisions and determinations that may be required under, or as
the Compensation Committee deems necessary or advisable to administer, the
Plan.
|
Awards
The
following is summary description of financial instruments that may be granted to
participants by the Compensation Committee of our board of directors. The
Compensation Committee to date has only granted stock options to participants in
the Plan.
Stock Options. The
Compensation Committee is authorized to grant both incentive stock options and
non-qualified stock options. The terms of any incentive stock option must meet
the requirements of Section 422 of the Internal Revenue Code. The exercise price
of an option may not be less than the fair market value of the underlying stock
on the date of grant, and no option may have a term of more than 10 years from
the grant date.
Stock Appreciation Rights.
The Compensation Committee may grant stock appreciation rights to participants.
Upon the exercise of a stock appreciation right, the participant has the right
to receive the excess, if any, of (1) the fair market value of one share of
common stock on the date of exercise, over (2) the grant price of the stock
appreciation right as determined by the Compensation Committee, which will not
be less than the fair market value of one share of common stock on the date of
grant.
Restricted Stock. The
Compensation Committee may make awards of restricted stock, which will be
subject to such restrictions on transferability and other restrictions as the
Compensation Committee may impose (including limitations on the right to vote
restricted stock or the right to receive dividends, if any, on the restricted
stock).
Performance Units. The
Compensation Committee may grant performance units on such terms and conditions
as may be selected by the Compensation Committee. The Compensation Committee
will have the complete discretion to determine the number of performance units
granted to each participant and to set performance goals and other terms or
conditions to payment of the performance units which, depending on the extent to
which they are met, will determine the number and value of performance units
that will be paid to the participant.
Dividend Equivalents. The
Compensation Committee is authorized to grant dividend equivalents to
participants subject to such terms and conditions as may be selected by the
Compensation Committee. Dividend equivalents entitle the participant to receive
payments equal to dividends with respect to all or a portion of the number of
shares of common stock subject to an option or other award, as determined by the
Compensation Committee. The Compensation Committee may provide that dividend
equivalents be paid or distributed when accrued or be deemed to have been
reinvested in additional shares of common stock, or otherwise
reinvested.
Other Stock-Based Awards. The
Compensation Committee may grant other awards that are payable in, valued in
whole or in part by reference to, or otherwise based on or related to shares of
common stock, as deemed by the Compensation Committee to be consistent with the
purposes of the Plan. These stock-based awards may include shares of common
stock awarded as a bonus and not subject to any restrictions or conditions,
convertible or exchangeable debt securities, other rights convertible or
exchangeable into shares of common stock, and awards valued by reference to book
value of shares of common stock or the value of securities of or the performance
of our subsidiaries. The Compensation Committee will determine the terms and
conditions of any such awards.
55
Performance Goals. The
Compensation Committee in its discretion may determine awards based
on:
·
|
the
achievement by CytRx or a parent or subsidiary of a specific financial
target;
|
·
|
CytRx’s
stock price;
|
·
|
the
achievement by an individual or a business unit of CytRx or a subsidiary
of a specific financial target;
|
·
|
the
achievement of specific goals with respect to (i) product development
milestones, (ii) corporate financings, (iii) merger and acquisition
activities, (iv) licensing transactions, (v) development of strategic
partnerships or alliances, or (vi) acquisition or development of new
technologies; and
|
·
|
any
combination of the goals set forth
above.
|
The
Compensation Committee has the right for any reason to reduce (but not increase)
any award, even if a specific goal has been achieved. If an award is made on the
basis of the achievement of a goal, the Compensation Committee must have
established the goal before the beginning of the period for which the
performance goal relates (or a later date as may be permitted under Internal
Revenue Code Section 162(m)). Any payment of an award for achieving a goal will
be conditioned on the written certification of the Compensation Committee in
each case that the goals and any other material conditions were
satisfied.
Limitations on Transfer;
Beneficiaries. Awards under the Plan may not be transferred or assigned
by Plan participants other than by will or the laws of descent and distribution
and, in the case of an incentive stock option, pursuant to a qualified domestic
relations order, provided that the Compensation Committee may (but need not)
permit other transfers where the Compensation Committee concludes that such
transferability (1) does not result in accelerated taxation, (2) does not cause
any option intended to be an incentive stock option to fail to qualify as such,
and (3) is otherwise appropriate and desirable, taking into account any factors
deemed relevant, including any state or federal tax or securities laws or
regulations applicable to transferable awards. A Plan participant may, in the
manner determined by the Compensation Committee, designate a beneficiary to
exercise the participant’s rights and to receive any distribution with respect
to any award upon the participant’s death.
Acceleration Upon Certain
Events. In the event of a “Change in Control” of CytRx, which is a term
defined in the Plan, all outstanding options and other awards in the nature of
rights that may be exercised will become fully vested and exercisable and all
restrictions on all outstanding awards will lapse. The Compensation Committee
may, however, in its sole discretion declare all outstanding options, stock
appreciation rights and other awards in the nature of rights that may be
exercised to become fully vested and exercisable, and all restrictions on all
outstanding awards to lapse, in each case as of such date as the Compensation
Committee may, in its sole discretion, declare. The Compensation Committee may
discriminate among participants or among awards in exercising such
discretion.
Termination
and Amendment
Our board
of directors or the Compensation Committee may, at any time and from time to
time, terminate or amend the Plan without stockholder approval; provided,
however, that our board or the Compensation Committee may condition any
amendment on the approval of our stockholders if such approval is necessary or
deemed advisable with respect to tax, securities or other applicable laws,
policies or regulations. No termination or amendment of the Plan may adversely
affect any award previously granted without the written consent of the
participants affected. The Compensation Committee may amend any outstanding
award without the approval of the participants affected, except that no such
amendment may diminish the value of an award determined as if it has been
exercised, vested, cashed in or otherwise settled on the date of such amendment,
and, except as otherwise permitted in the Plan, the exercise price of any option
may not be reduced and the original term of any option may not be
extended.
Other
Plans
We also
have two other plans, the 1994 Stock Option Plan and the 1998 Long Term
Incentive Plan, which include 9,167 and 27,500 shares subject to outstanding
stock options. As the terms of the plans provide that no options may be issued
after 10 years, no options are available under either the 1994 Plan or the 1998
Plan.
56
On
November 21, 2008, our board of directors adopted the 2008 Stock Incentive Plan,
which will be submitted for approval by our stockholders at the 2009 Annual
Meeting of stockholders. In the meantime, we may make awards under the 2008
Plan, the effectiveness of which are conditioned upon obtaining such stockholder
approval. There are 350,000 shares subject to outstanding options
awarded under the Plan, and 9,650,000 shares available for future
awards.
Holdings
of Previously Awarded Equity
Equity
awards held as of December 31, 2008 by each of our named executive officers were
issued under our 2000 Long-Term Incentive Plan. The following table sets forth
outstanding equity awards held by our named executive officers as of December
31, 2008:
2008
Outstanding Equity Awards at Fiscal Year-End
Option Awards
|
|||||||||
Number
of Securitiesa
Underlying
Unexercised
Options
(#)
|
Option
Exercise Price
|
Option
Expiration
|
|||||||
Name
|
Exercisable
|
Unexercisable
|
($)
|
Date
|
|||||
Steven
A. Kriegsman
|
8,333
|
(1)
|
291,667
|
0.37
|
11/21/18
|
||||
President
and Chief Executive Officer
|
100,000
|
(1)
|
350,000
|
1.21
|
4/07/18
|
||||
194,444
|
(1)
|
155,556
|
4.51
|
4/18/17
|
|||||
166,667
|
(1)
|
33,333
|
1.38
|
6/16/16
|
|||||
300,000
|
(1)
|
—
|
0.79
|
5/17/15
|
|||||
250,000
|
(2)
|
—
|
2.47
|
6/19/13
|
|||||
750,000
|
(2)
|
—
|
2.47
|
6/20/13
|
|||||
Mitchell
K. Fogelman (3)
|
2,778
|
(1)
|
97,222
|
0.37
|
11/21/18
|
||||
Chief
Financial Officer and Treasurer
|
22,222
|
(1)
|
77,778
|
1.21
|
4/07/18
|
||||
62,500
|
(1)
|
87,500
|
3.40
|
9/11/17
|
|||||
Jack
R. Barber, Ph.D.
|
2,778
|
(1)
|
97,222
|
0.37
|
11/21/18
|
||||
Chief
Scientific Officer
|
22,222
|
(1)
|
77,778
|
1.21
|
4/07/18
|
||||
111,111
|
(1)
|
88,889
|
4.51
|
4/18/17
|
|||||
83,333
|
(1)
|
16,667
|
1.38
|
6/16/16
|
|||||
150,000
|
(1)
|
20,846
|
0.79
|
5/17/15
|
|||||
100,000
|
(2)
|
—
|
1.13
|
7/06/14
|
|||||
Benjamin
S. Levin
|
2,778
|
(1)
|
97,222
|
0.37
|
11/21/18
|
||||
General
Counsel, Vice President — Legal Affairs
|
22,222
|
(1)
|
77,778
|
1.21
|
4/07/18
|
||||
and Secretary
|
55,556
|
(1)
|
44,444
|
4.51
|
4/18/17
|
||||
75,000
|
(1)
|
15,000
|
1.38
|
6/16/16
|
|||||
150,000
|
(1)
|
—
|
0.79
|
5/17/15
|
|||||
160,000
|
(2)
|
—
|
1.39
|
7/15/14
|
|||||
Shi
Chung Ng, Ph.D.
|
—
|
(2)
|
50,000
|
0.37
|
11/21/18
|
||||
Senior
Vice President – Research and Development
|
50,000
|
(2)
|
100,000
|
4.13
|
4/30/17
|
||||
____________
(1)
|
These
options vest in 36 equal monthly installments, subject to the option
holder’s remaining in our continuous employ through such
dates.
|
(2)
|
These
options vest in three annual installments, subject to the option holder’s
remaining in our continuous employ through such
dates.
|
(3)
|
Mr.
Fogelman resigned from the company on December 31,
2008.
|
57
Option
Exercises and Stock Vested
There
were no exercises of stock options by any of our named executive officers during
2008.
Employment
Agreements and Potential Payment upon Termination or Change in
Control
Employment
Agreement with Steven A. Kriegsman
Mr.
Kriegsman is employed as our Chief Executive Officer and President pursuant to
an employment agreement that was amended as of May 2007 to continue through
December 31, 2009. The employment agreement will automatically renew in December
2009 for an additional one-year period, unless either Mr. Kriegsman or we elect
not to renew it.
Under his
employment agreement as amended, Mr. Kriegsman is entitled to receive an annual
base salary of $550,000. Our board of directors (or its Compensation Committee)
will review the base salary annually and may increase (but not decrease) it in
its sole discretion. 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 President
and that he may continue to serve as Chairman 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.
Kriegsman’s 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. Kriegsman’s 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 any compensation
received from any subsequent reemployment by another employer.
Under Mr.
Kriegsman’s 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. Kriegsman’s
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.
Potential
Payment upon Termination or Change in Control for Steven A.
Kriegsman
Mr.
Kriegsman’s 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. Kriegsman’s
58
employment
is terminated by us without cause or by him for good reason (each as defined in
his employment agreement), then, in addition to the severance benefits described
above, 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 sum of (i) the excise tax on such payments
plus (ii) any penalty and interest assessments associated with such excise
tax.
Employment
Agreement with John Y. Caloz
John Y.
Caloz is employed as our Chief Financial Officer and Treasurer pursuant to an
employment agreement dated as of January 1, 2009 that expires on December 31,
2009. Mr. Caloz is entitled under his employment agreement to receive an annual
base salary of $275,000 and is eligible to receive an annual bonus as determined
by our board of directors (or our Compensation Committee) in its sole
discretion.
In the
event we terminate Mr. Caloz’s 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 six months’ salary under his employment
agreement.
Employment
Agreement with Jack R. Barber, Ph.D.
Jack R.
Barber, Ph.D. is employed as our Chief Scientific Officer pursuant to an
employment agreement dated as of January 1, 2009 that expires on December 31,
2009. Dr. Barber is paid an annual base salary of $360,000 and is eligible to
receive an annual bonus as determined by our board of directors (or our
Compensation Committee) in its sole discretion.
In the
event we terminate Dr. Barber’s 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 six months’ base salary.
Employment
Agreement with Shi Chung Ng, Ph.D.
Shi Chung
Ng, Ph.D. is employed as our Senior Vice President — Research and Development
pursuant to an employment agreement dated as of January 1, 2009 that expires on
December 31, 2009. Dr. Ng is paid an annual base salary of $275,000 and is
eligible to receive an annual bonus as determined by our board of directors (or
our Compensation Committee) in its sole discretion.
In the
event we terminate Dr. Ng’s 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 six months’ base salary.
Employment
Agreement with Scott Wieland, Ph.D.
Scott
Wieland is employed as our Senior Vice President — Drug Development pursuant to
an employment agreement dated as of January 1, 2009 that expires on December 31,
2009. Dr. Wieland is paid an annual base salary of $275,000 and is eligible to
receive an annual bonus as determined by our board of directors (or our
Compensation Committee) in its sole discretion.
In the
event we terminate Dr. Wieland’s 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 six months’ base salary.
Employment
Agreement with Benjamin S. Levin
Benjamin
S. Levin is employed as our Vice President — Legal Affairs, General Counsel and
Secretary pursuant to an employment agreement dated as of January 1, 2009 that
expires on December 31, 2009. Mr. Levin is paid an annual base salary of
$275,000 and is eligible to receive an annual bonus as determined by our board
of directors (or our Compensation Committee) in its sole
discretion.
In the
event we terminate Mr. Levin’s employment without “cause” (as defined), we have
agreed to pay him a lump-sum equal to his accrued but unpaid salary and
vacation, plus an amount equal to six months’ base salary.
59
Quantification
of Termination Payments and Benefits
The table
below reflects the amount of compensation to each of our named executive
officers in the event of termination of such executive’s employment without
“cause” or his resignation for “good reason,” termination following a change in
control and termination upon the executive’s death of permanent disability. The
named executive officers are not entitled to any payments other than accrued
compensation and benefits in the event of their voluntary resignation. The
amounts shown in the table below assume that such termination was effective as
of December 31, 2008, and thus includes amounts earned through such time, and
are estimates only of the amounts that would be payable to the executives. The
actual amounts to be paid will be determined upon the occurrence of the events
indicated.
Termination
Payments and Benefits
Termination
w/o Cause or
for Good Reason
|
||||||||||||
Name
|
Benefit
|
Before
Change in
Control ($)
|
After
Change in
Control ($)
|
Death ($)
|
Disability ($)
|
Change
in
Control ($)
|
||||||
Steven
A. Kriegsman
|
Severance
Payment(4)
|
1,000,000
|
1,000,000
|
1,000,000
|
1,000,000
|
—
|
||||||
President
and Chief Executive
Officer
|
Stock
Options (1)
|
—
|
—
|
—
|
—
|
—
|
||||||
|
Health
Insurance (2)
|
80,609
|
80,609
|
—
|
80,609
|
80,609
|
||||||
Life
Insurance
|
10,000
|
10,000
|
—
|
10,000
|
—
|
|||||||
Bonus
|
300,000
|
300,000
|
300,000
|
300,000
|
—
|
|||||||
Tax
Gross Up (3)
|
—
|
—
|
—
|
—
|
—
|
|||||||
Jack
R. Barber, Ph.D.
|
Severance
Payment(4)
|
180,000
|
180,000
|
—
|
—
|
—
|
||||||
Chief
Scientific Officer
|
Stock
Options (1)
|
—
|
—
|
—
|
—
|
—
|
||||||
Benjamin
S. Levin
|
Severance
Payment
|
137,500
|
137,500
|
—
|
—
|
—
|
||||||
General
Counsel, Vice President
— Legal Affairs
and Secretary
|
Stock
Options (1)
|
—
|
—
|
—
|
—
|
—
|
||||||
|
||||||||||||
Shi
Chung Ng, Ph.D.(4)
|
Severance
Payment(4)
|
137,500
|
137,500
|
—
|
—
|
—
|
||||||
Senior
Vice President – Drug
Development
|
Stock
Options (1)
|
—
|
—
|
—
|
—
|
—
|
||||||
|
____________
(1)
|
Represents
the aggregate value of stock options that vest and become exercisable
immediately upon each of the triggering events listed as if such events
took place on December 31, 2008, determined by the aggregate difference
between the stock price as of December 31, 2008 and the exercise prices of
the underlying options. The value is $0, since the stock price at December
31, 2008 was below the exercise price of all underlying
options.
|
(2)
|
Represents
the cost as of December 31, 2008 for the family health benefits provided
to Mr. Kriegsman for a period of two
years.
|
(3)
|
Mr.
Kriegsman’s employment agreement provides that if 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. Kriegsman’s
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 will 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 sum of (i) the excise tax on such payments plus
(ii) any penalty and interest assessments associated with such excise tax.
Based on Mr. Kriegsman’s past compensation and the estimated payment that
would result from a termination of his employment following a change in
control, we have estimated that a gross-up payment would not be required.
“Good reason” as defined in Mr. Kriegsman’s employment agreement includes
any change in Mr. Kriegsman’s duties or title that are inconsistent with
his position as Chief Executive
Officer.
|
(4)
|
Severance
payments are prescribed by our employment agreements with the named
executive officers and represent a factor of their annual base
compensation ranging from six months to two
years.
|
60
|
(5)
Mr. Fogelman, our Chief Financial Officer during the year, resigned from
the Company on December 31, 2008 and was not paid any termination payments
or benefits.
|
Compensation
of Directors
The
following table sets forth the compensation paid to our directors other than our
Chief Executive Officer for 2008:
Director
Compensation Table
Name
(1)
|
Fees
Earned or
Paid
in Cash ($)(2)
|
Option
Awards
($) (3)
|
Total
($)
|
|||
Max
Link, Ph.D.
|
118,000
|
11,225
|
129,225
|
|||
Chairman
|
||||||
Marvin
R. Selter
|
106,500
|
11,225
|
117,725
|
|||
Vice
Chairman
|
||||||
Louis
Ignarro, Ph.D.
|
40,500
|
11,225
|
51,725
|
|||
Director
|
||||||
Joseph
Rubinfeld, Ph.D.
|
74,000
|
11,225
|
85,225
|
|||
Director
|
||||||
Richard
L. Wennekamp
|
83,500
|
11,225
|
94,725
|
|||
Director
|
____________
(1)
|
Steven
A. Kriegsman does not receive additional compensation for his role as a
Director. For information relating to Mr. Kriegsman’s compensation as
President and Chief Executive Officer, see the Summary Compensation Table
above.
|
(2)
|
The
amounts in this column represent cash payments made to Non-Employee
Directors for attendance at meetings during the
year.
|
(3)
|
In
July 2008, we granted stock options to purchase 25,000 shares of our
common stock at an exercise price equal to the current market value of our
common stock to each non-employee director, which had a grant date fair
value of $11,225 calculated in accordance with SFAS 123(R). Pursuant to
SEC rules, the amounts shown exclude the impact of estimated forfeitures
related to service-based vesting conditions. The amount recognized for
these awards was calculated using the Black Scholes option-pricing model,
and reflect grants from our 2000 Long-Term Incentive Plan, which is
described in Note 12 of the Notes to Consolidated Financial
Statements.
|
We use a
combination of cash and stock-based compensation to attract and retain qualified
candidates to serve on our board of directors. Directors who also are employees
of our company currently receive no compensation for their service as directors
or as members of board committees. In setting director compensation, we consider
the significant amount of time that directors dedicate to the fulfillment of
their director responsibilities, as well as the competency and skills required
of members of our board. The directors’ current compensation schedule has been
in place since May 2007. The directors’ annual compensation year begins with the
annual election of directors at the annual meeting of stockholders. The annual
retainer year period has been in place for directors since 2003. 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.
Our
non-employee directors receive a quarterly retainer of $6,000 (plus an
additional $12,500 for the Chairman of the Board, $5,000 for the Chairman of the
Audit Committee, and $1,500 for the Chairmen of the Nomination and Governance
Committee and the Compensation Committee), a fee of $3,000 for each board
meeting attended ($750 for board actions taken by unanimous written consent),
$2,000 for each meeting of the Audit Committee attended, and $1,000 for each
other committee meeting attended. Non-employee directors who serve as the
chairman of a board committee receive an additional $2,000 for each meeting of
the Nomination and Governance Committee or the Compensation Committee attended
and an additional $2,500 for each meeting attended of the audit committee. In
July 2008, we granted stock options to purchase 25,000 shares of our common
stock at an exercise price equal to the current market value of our common stock
to each non-employee director. The options were vested, in full, upon
grant.
Joseph
Rubinfeld, Ph.D. Consulting Agreement
On
December 2, 2008, we entered into a written consulting agreement with Joseph
Rubinfeld, Ph.D., under which Dr. Rubinfeld agrees to serve as our Chief
Scientific Advisor. In exchange, we granted to Dr. Rubinfeld under our 2008
Stock Incentive Plan a ten
61
year
stock option to purchase up to 350,000 shares of our common stock at an exercise
price of $0.35 per share, which equaled the market price of our common stock as
of the grant date. The stock option vested immediately upon grant as to 50,000
of the option shares and will vest as to the remaining option shares in
installments of 100,000 shares each on the first three anniversaries of the
grant date, subject in each case to Dr. Rubinfeld remaining in our service
through such dates. We also agree in the consulting agreement to pay Dr.
Rubinfeld a monthly fee of $1,000. The consulting agreement is terminable at any
time by either party upon notice to the other party.
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
March 11, 2009 by (1) each person who is known by us to beneficially own more
than five percent of our common stock; (2) each of our directors; (3) the named
executive officers listed in the Summary Compensation Table under Item 11; and
(4) all of our 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 March 11, 2009 (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 93,981,548 shares of our
common stock outstanding as of March 11, 2009. 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)
|
568,916
|
*
|
||
Steven
A. Kriegsman(2)
|
5,947,497
|
6.2%
|
||
Max
Link, Ph.D.(3)
|
189,519
|
*
|
||
Joseph
Rubinfeld, Ph.D.(4)
|
127,000
|
*
|
||
Marvin
R. Selter(5)
|
472,451
|
*
|
||
Richard
L. Wennekamp(6)
|
120,000
|
*
|
||
Jack
R. Barber, Ph.D.(7)
|
561,112
|
*
|
||
Shi
Chung Ng, Ph.D.(8)
|
106,953
|
*
|
||
Benjamin
S. Levin(9)
|
511,676
|
*
|
||
All
executive officers and directors as a group (eleven
persons)(10)
|
8,677,902
|
8.8%
|
____________
(1)
|
Includes
477,000 shares subject to options or
warrants.
|
(2)
|
Includes
1,926,397 shares subject to options or warrants. Mr. Kriegsman’s address
is c/o CytRx Corporation, 11726 San Vicente Boulevard, Suite 650, Los
Angeles, CA 90049.
|
(3)
|
Includes
134,543 shares subject to options or
warrants.
|
(4)
|
Includes
127,000 shares subject to options or
warrants.
|
(5)
|
The
shares shown are owned, of record, by the Selter Family Trust or Selter
IRA Rollover. Includes 115,000 shares subject to options or warrants owned
by Mr. Selter.
|
(6)
|
Includes
115,000 shares subject to options or
warrants.
|
(7)
|
Includes
561,112 shares subject to options or
warrants.
|
(8)
|
Includes
106,935 shares subject to options or
warrants.
|
(9)
|
Includes
511,676 shares subject to options or
warrants.
|
(10)
|
Includes
4,147,459 shares subject to options or
warrants.
|
62
Item
13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS
Director
Independence
Our board
of directors has determined that Messrs. Link, Selter, Ignarro and Wennekamp are
“independent” under the current independence standards of both The NASDAQ
Capital 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.
Transactions
with Related Persons
General
Our Audit
Committee is responsible for reviewing and approving, as appropriate, all
transactions with related persons, in accordance with its Charter and NASDAQ
Marketplace Rules.
Transactions
between us and one or more related persons may present risks or conflicts of
interest or the appearance of conflicts of interest. Our Code of Ethics requires
all employees, officers and directors to avoid activities or relationships that
conflict, or may be perceived to conflict, with our interests or adversely
affect our reputation. It is understood, however, that certain relationships or
transactions may arise that would be deemed acceptable and appropriate so long
as there is full disclosure of the interest of the related parties in the
transaction and review and approval by disinterested directors to ensure there
is a legitimate business reason for the transaction and that the transaction is
fair to us and our stockholders.
As a
result, the procedures followed by the Audit Committee to evaluate transactions
with related persons require:
·
|
that
all related person transactions, all material terms of the transactions,
and all the material facts as to the related person’s direct or indirect
interest in, or relationship to, the related person transaction must be
communicated to the Audit Committee;
and
|
·
|
that
all related person transactions, and any material amendment or
modification to any related person transaction, be reviewed and approved
or ratified by the Audit Committee, as required by NASDAQ Marketplace
Rules.
|
Our Audit
Committee will evaluate related person transactions based on:
·
|
information
provided by members of our board of directors in connection with the
required annual evaluation of director
independence;
|
·
|
pertinent
responses to the Directors’ and Officers’ Questionnaires submitted
periodically by our officers and directors and provided to the Audit
Committee by our management;
|
·
|
background
information on nominees for director provided by the Nominating and
Corporate Governance Committee of our board of directors;
and
|
·
|
any
other relevant information provided by any of our directors or
officers.
|
In
connection with its review and approval or ratification, if appropriate, of any
related person transaction, our Audit Committee is to consider whether the
transaction will compromise standards included in our Code of Ethics. In the
case of any related person transaction involving an outside director or nominee
for director, the Audit Committee also is to consider whether the transaction
will compromise the director’s status as an independent director as prescribed
in the NASDAQ Marketplace Rules.
63
Recent
Transactions
In 2008,
we entered into several written consulting agreements with TS Biopharma, an
oncology clinical consulting company owned by Steven Rubinfeld, M.D. Dr.
Rubinfeld is the son of Joseph Rubinfeld, Ph.D., one of our directors. Joseph
Rubinfeld has no financial interest in the consulting arrangement. Under the
consulting arrangement, we agreed to pay TS Biopharma on an hourly basis for
consulting services related to the evaluation of our oncology compounds and the
design and administration of our clinical oncology program. The
consulting arrangement is terminable by either party at any time upon notice to
the other party.
During
2008, we paid approximately $273,000 in total consulting fees to TS Biopharma.
We cannot predict the future compensation to be paid by us to TS Biopharma,
since it will depend on the hours spent in consulting with us.
Exemption
Clause
Item
404(a)(7)(a) of Securities and Exchange Commission Regulation S-K states that:
Disclosure need not be provided if the transaction is one where the rates or
charges involved in the transaction are determined by competitive bid, or the
transaction involves rendering of services as a common or contract carrier, or
public utility, at rates or charges fixed in conformity with law or governmental
authority.
Applicable
Definitions
For
purposes of our Audit Committee’s review:
·
|
“related
person” has the meaning given to such term in Item 404(a) of Securities
and Exchange Commission Regulation S-K (“Item 404(a)”);
and
|
·
|
“related
person transaction” means any transaction for which disclosure is required
under the terms of Item 404(a) involving the Company and any related
persons.
|
Item
14. PRINCIPAL ACCOUNTANT FEES AND
SERVICES
BDO
Seidman, LLP, or BDO, serves as our independent registered public accounting
firm and audited our financial statements for the years ended December 31, 2008,
2007 and 2006.
Audit
Fees
The fees
for 2008 and 2007 billed to us by BDO for professional services rendered for the
audit of our annual consolidated financial statements and internal controls over
financial reporting were $350,311 and $656,000, respectively.
Audit-Related
Fees
BDO
rendered $152,262 of assurance and other related services in 2008, which
included services relating to our shelf registration with the SEC and the
Innovive acquisition, and $804,000 of audit-related services in
2007.
Tax
Fees
The
aggregate fees billed by BDO for professional services for tax compliance, tax
advice and tax planning were $39,000, $43,000 and $25,000 for 2008, 2007 and
2006, respectively.
All
Other Fees
No other
services were rendered by BDO for 2008 or 2007.
64
Pre-Approval
Policies and Procedures
It is the
policy of our Audit Committee that all services to be provided by our
independent registered public accounting firm, including audit services and
permitted audit-related and non-audit services, must be pre-approved by our
Audit Committee. Our Audit Committee pre-approved all services, audit and
non-audit, provided to us by BDO for 2008 and 2007.
65
PART
IV
Item
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The
following documents are filed as part of this 10-K:
(1) Financial
Statements
Our
consolidated financial statements and the related report of the independent
registered public accounting firm thereon are set forth on pages F-1 to F-25 of
this Annual Report. These consolidated financial statements are as
follows:
Consolidated
Balance Sheets as of December 31, 2008 and 2007
Consolidated
Statements of Operations for the Years Ended December 31, 2008, 2007 and
2006
Consolidated
Statements of Stockholders’ Equity for the Years Ended December 31, 2008, 2007
and 2006
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2008, 2007 and
2006
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-25 of this Annual
Report.
Schedule
II — Valuation and Qualifying Accounts for the years ended December 31, 2008,
2007 and 2006
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 67 of this Annual Report, which is incorporated herein by
reference.
66
CytRx
Corporation
Form
10-K Exhibit Index
Exhibit
Number
|
Description
|
Footnote
|
||
3.1
|
Amended
and Restated Certificate of Incorporation, as amended
|
(a)
|
||
3.2
|
Restated
By-Laws, as amended
|
(a)
|
||
4.1
|
Shareholder
Protection Rights Agreement dated April 16, 1997 between CytRx Corporation
and American Stock Transfer &Trust Company as Rights
Agent
|
(b)
|
||
4.2
|
Amendment
No. 1 to Shareholder Protection Rights Agreement
|
(e)
|
||
4.3
|
Amendment
No. 2 to Shareholder Protection Rights Agreement
|
(r)
|
||
4.4
|
Warrant
issued on May 10, 2004 to MBN Consulting, LLC
|
(i)
|
||
4.5
|
Form
of Common Stock Purchase Warrant between CytRx Corporation and each of the
investors in the October 4, 2004 private placement
|
(j)
|
||
4.6
|
Form
of Common Stock Purchase Warrant between CytRx Corporation and each of the
investors in the January 2005 private placement
|
(k)
|
||
4.7
|
Form
of Common Stock Purchase Warrant between CytRx Corporation and each of the
investors in the March 2006 private placement
|
(p)
|
||
10.1*
|
1994
Stock Option Plan, as amended and restated
|
(c)
|
||
10.2*
|
1998
Long-Term Incentive Plan
|
(d)
|
||
10.3*
|
2000
Long-Term Incentive Plan
|
(e)
|
||
10.4*
|
Amendment
No. 1 to 2000 Long-Term Incentive Plan
|
(g)
|
||
10.5*
|
Amendment
No. 2 to 2000 Long-Term Incentive Plan
|
(g)
|
||
10.6*
|
Amendment
No. 3 to 2000 Long-Term Incentive Plan
|
(h)
|
||
10.7*
|
Amendment
No. 4 to 2000 Long-Term Incentive Plan
|
(h)
|
||
10.8*
|
2008
Stock Incentive Plan
|
|||
10.9†
|
License
Agreement dated December 7, 2001 by and between CytRx Corporation and
Vical Incorporated
|
(f)
|
||
10.10†
|
Agreement
between CytRx Corporation and Dr. Robert Hunter regarding SynthRx, Inc
dated October 20, 2003
|
(h)
|
||
10.11
|
Office
Lease between The Kriegsman Group and Douglas Emmett, dated April 13,
2000
|
(h)
|
||
10.12
|
Assignment
to CytRx Corporation effective July 1, 2003 of Office Lease between The
Kriegsman Group and Douglas Emmett, dated April 13, 2000
|
(h)
|
||
10.13
|
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
|
(j)
|
||
10.14
|
Sublease
dated March 14, 2005 between Innovive Pharmaceuticals, Inc. and Friedman,
Billings, Ramsey Group, Inc.
|
(l)
|
||
10.15*
|
Amended
and Restated Employment Agreement dated May 17, 2005 between CytRx
Corporation and Steven A. Kriegsman
|
(m)
|
||
10.16
|
First
Amendment to Office Lease dated October 14, 2005, by and between CytRx
Corporation and Douglas Emmett 1993, LLC
|
(n)
|
||
10.17†
|
License
Agreement dated December 28, 2005 between Innovive Pharmaceuticals, Inc.
and Nippon Shinyaku Co., Ltd.
|
(l)
|
||
10.18†
|
License
Agreement dated April 17, 2006 between Innovive Pharmaceuticals, Inc. and
KTB Tumorforschungs GmbH
|
(o)
|
||
10.19
|
Royalty
Agreement dated August 28, 2006 between CytRx Corporation and Kenneth
Council, as Trustee of the ALS Charitable Remainder Trust
|
(q)
|
||
10.20†
|
License
Agreement dated December 6, 2006 between Innovive Pharmaceuticals, Inc.
and TMRC Co., Ltd.
|
(s)
|
||
10.21
|
Contribution
Agreement, dated as of January 8, 2007, between CytRx Corporation and RXi
Pharmaceuticals Corporation
|
(t)
|
||
10.22
|
Voting
agreement, dated as of January 10, 2007, between CytRx Corporation and the
University of Massachusetts
|
(t)
|
||
10.23
|
Stockholders
agreement, dated February 23, 2007, among CytRx Corporation, RXi
Pharmaceuticals Corporation, Craig C. Mello, Ph.D., Tariq Rana, Ph.D.,
Gregory J. Hannon, Ph.D., and Michael P. Czech, Ph.D
|
(t)
|
||
10.24
|
Form
of Purchase Agreement, dated as of April 17, 2007, by and between CytRx
Corporation and each of the selling stockholders named
therein
|
(u)
|
||
10.25
|
Contribution
Agreement, dated as of April 30, 2007, between CytRx Corporation and RXi
Pharmaceuticals Corporation
|
(t)
|
||
10.26
|
Lease
dated July 20, 2007, between CytRx Corporation and BMR-3030 Bunker Hill
Street LLC
|
(v)
|
||
10.27
|
Agreement
and Plan of Merger, dated as of June 6, 2008, among CytRx
Corporation, CytRx Merger Subsidiary, Inc., Innovive Pharmaceuticals,
Inc., and Steven Kelly
|
(w)
|
||
10.28
|
Loan
and Security Agreement, dated as of June 6, 2008, between CytRx
Corporation and Innovive Pharmaceuticals, Inc.
|
(w)
|
||
10.29
|
Second
Amendment to Office Lease dated June 30, 2008, by and between CytRx
Corporation and Douglas Emmett 1993, LLC
|
|||
10.30
|
Amendment
to Contribution Agreement, dated July 28, 2008, between CytRx
Corporation and RXi Pharmaceuticals Corporation
|
(x)
|
||
10.31
|
Amendment
to Stockholders Agreement, dated July 28, 2008, among CytRx
Corporation, RXi Pharmaceuticals Corporation, and Michael P. Czech, PhD.,
Gregory J. Hannon, Ph.D., Craig C. Mello, PhD., and Tariq M. Rana,
Ph.D.
|
(x)
|
||
10.32
|
Sub-Sublease
dated December 4, 2008, by and between CytRx Oncology Corporation and Red
Pine Advisors LLC
|
|||
10.33*
|
Employment
Agreement dated January 1, 2009, between CytRx Corporation and Jack R.
Barber
|
|||
10.34*
|
Employment
Agreement dated January 1, 2009, between CytRx Corporation and Shi Chung
Ng
|
|||
10.35*
|
Employment
Agreement dated January 1, 2009, between CytRx Corporation and Benjamin S.
Levin
|
|||
10.36*
|
Employment
Agreement dated January 1, 2009, between CytRx Corporation and Scott
Wieland
|
|||
10.37*
|
Employment
Agreement dated January 1, 2009, between CytRx Corporation and John Y.
Caloz
|
|||
10.38
|
Investment
Banking Agreement, dated January 29, 2009, by and between CytRx
Corporation and Legend Securities, Inc.
|
|||
23.1
|
Consent
of BDO Seidman, LLP
|
|||
31.1
|
Certification
of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|||
31.2
|
Certification
of Chief Financial Officer Pursuant to 15 U.S.C. Section 7241, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|||
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|||
32.2
|
Certification
of Chief Financial Officer 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 Registrant’s Form 10-K filed on April 1,
2008
|
(b)
|
Incorporated
by reference to the Registrant’s 8-K filed on April 17,
1997
|
(c)
|
Incorporated
by reference to the Registrant’s 10-Q filed on August 14,
1997
|
(d)
|
Incorporated
by reference to the Registrant’s Proxy Statement filed on April 30,
1998
|
(e)
|
Incorporated
by reference to the Registrant’s Form 10-K filed on March 27,
2001
|
(f)
|
Incorporated
by reference to the Registrant’s Form 8-K filed on December 21,
2001
|
(g)
|
Incorporated
by reference to the Registrant’s Proxy Statement filed June 11,
2002
|
(h)
|
Incorporated
by reference to the Registrant’s 10-K filed on May 14,
2004
|
(i)
|
Incorporated
by reference to the Registrant’s 10-Q filed on August 16,
2004
|
(j)
|
Incorporated
by reference to the Registrant’s 8-K filed on October 5,
2004
|
(k)
|
Incorporated
by reference to the Registrant’s 8-K filed on January 21,
2005
|
(l)
|
Incorporated
by reference to the Innovive Pharmaceuticals Form 10 filed on April 20,
2006
|
(m)
|
Incorporated
by reference to the Registrant’s 10-Q filed on August 15,
2005
|
(n)
|
Incorporated
by reference to the Registrant’s 8-K filed on October 20,
2005
|
(o)
|
Incorporated
by reference to the Innovive Pharmaceuticals 10-Q filed on November 14,
2006
|
67
(p)
|
Incorporated
by reference to the Registrant’s 8-K filed on March 3,
2006
|
(q)
|
Incorporated
by reference to the Registrant’s 10-Q filed on November 13,
2006
|
(r)
|
Incorporated
by reference to the Registrant’s 10-K filed on April 2,
2007
|
(s)
|
Incorporated
by reference to the Innovive Pharmaceuticals 10-K filed on March 21,
2007
|
(t)
|
Incorporated
by reference to the Registrant’s 10-Q filed on May 10,
2007
|
(u)
|
Incorporated
by reference to the Registrant’s 8-K filed on April 18,
2007
|
(v)
|
Incorporated
by reference to the Registrant’s 10-Q filed on August 9,
2007
|
(w)
|
Incorporated
by reference to the Registrant’s 8-K filed on June 9,
2008
|
(x)
|
Incorporated
by reference to the Registrant’s 10-Q filed on August 11,
2008
|
68
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.
Date:
March 11,
2009 CYTRX
CORPORATION
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
President and Chief Executive
Officer
69
INDEX
TO FINANCIAL STATEMENTS
AND
FINANCIAL STATEMENT SCHEDULE
CytRx
Corporation
|
Page
|
|
F-2
|
||
F-3
|
||
F-4
|
||
F-5
|
||
F-7
|
||
F-23
|
||
F-25
|
F-1
CYTRX
CORPORATION
CONSOLIDATED
BALANCE SHEETS
December 31,
|
||||||||
2008
|
2007
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 25,041,772 | $ | 50,498,261 | ||||
Short-term
investments, at amortized cost
|
— | 9,951,548 | ||||||
Accounts
receivable
|
127,280 | 101,217 | ||||||
Income
taxes recoverable
|
215,623 | — | ||||||
Prepaid
expenses and other current assets
|
486,609 | 930,596 | ||||||
Total
current assets
|
25,871,284 | 61,481,622 | ||||||
Equipment
and furnishings, net
|
1,835,052 | 1,573,290 | ||||||
Molecular
library, net
|
103,882 | 193,946 | ||||||
Goodwill
|
183,780 | 183,780 | ||||||
Other
assets
|
330,032 | 713,398 | ||||||
Total
assets
|
$ | 28,324,030 | $ | 64,146,036 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 668,422 | $ | 1,946,215 | ||||
Accrued
expenses and other current liabilities
|
2,556,904 | 3,700,866 | ||||||
Deferred
revenue, current portion
|
1,817,600 | 8,399,167 | ||||||
Total
current liabilities
|
5,042,926 | 14,046,248 | ||||||
Deferred
revenue, non-current portion
|
7,582,797 | 7,167,381 | ||||||
Total
liabilities
|
12,625,723 | 21,213,629 | ||||||
Minority
interest
|
— | 2,708,368 | ||||||
Commitment
and contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Preferred
Stock, $.01 par value, 5,000,000 shares authorized, including 15,000
shares of Series A Junior Participating Preferred Stock; no shares issued
and outstanding
|
— | — | ||||||
Common
stock, $.001 par value, 175,000,000 shares authorized; 93,978,448 and
90,397,867 shares issued and outstanding at December 31, 2008 and 2007,
respectively
|
93,978 | 90,398 | ||||||
Additional
paid-in capital
|
210,007,468 | 203,905,691 | ||||||
Treasury
stock, at cost (633,816 shares held, at December 31, 2008 and 2007,
respectively)
|
(2,279,238 | ) | (2,279,238 | ) | ||||
Accumulated
deficit
|
(192,123,901 | ) | (161,492,812 | ) | ||||
Total
stockholders’ equity
|
15,698,307 | 40,224,039 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 28,324,030 | $ | 64,146,036 |
The
accompanying notes are an integral part of these consolidated financial
statements.
F-2
CYTRX CORPORATION
CONSOLIDATED
STATEMENTS OF OPERATIONS
Years Ended December 31,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
Revenue:
|
||||||||||||
Service
revenue
|
$ | 6,166,150 | $ | 7,241,920 | $ | 1,858,772 | ||||||
Licensing
revenue
|
100,000 | 101,000 | 101,000 | |||||||||
Grant
revenue
|
— | 116,118 | 105,930 | |||||||||
6,266,150 | 7,459,038 | 2,065,702 | ||||||||||
Expenses:
|
||||||||||||
Research
and development
|
10,465,591 | 18,823,802 | 9,781,007 | |||||||||
General
and administrative
|
10,932,522 | 14,822,142 | 9,657,257 | |||||||||
In-process
research and development
|
8,012,154 | — | — | |||||||||
Depreciation
and amortization
|
624,980 | 272,229 | 227,704 | |||||||||
30,035,247 | 33,918,173 | 19,665,968 | ||||||||||
Loss
before other income
|
(23,769,097 | ) | (26,459,135 | ) | (17,600,266 | ) | ||||||
Other
income:
|
||||||||||||
Interest
and dividend income
|
1,203,629 | 2,663,542 | 996,647 | |||||||||
Other
income (expense), net
|
219,489 | 1,496,979 | (3,205 | ) | ||||||||
Equity
in loss of affiliate – RXi Pharmaceuticals
|
(3,915,514 | ) | — | — | ||||||||
Minority
interest in loss of subsidiary
|
88,375 | 448,671 | — | |||||||||
Net
loss before provision for income taxes
|
(26,173,118 | ) | (21,849,943 | ) | (16,606,824 | ) | ||||||
Provision
for income taxes
|
(873,003 | ) | (40,000 | ) | (145,000 | ) | ||||||
Net
loss
|
(27,046,121 | ) | (21,889,943 | ) | (16,751,824 | ) | ||||||
Deemed
dividend for anti-dilution adjustments made to outstanding common stock
warrants
|
(756,954 | ) | — | (488,429 | ) | |||||||
Net
loss applicable to common stockholders
|
$ | (27,803,075 | ) | $ | (21,889,943 | ) | $ | (17,240,253 | ) | |||
Basic
and diluted loss per share
|
$ | (0.30 | ) | $ | (0.26 | ) | $ | (0.25 | ) | |||
Basic
and diluted weighted average shares outstanding
|
91,383,934 | 84,006,728 | 68,105,626 |
The
accompanying notes are an integral part of these consolidated financial
statements.
F-3
CYTRX CORPORATION
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
Additional
|
||||||||||||||||||||||||
Common Stock
|
Paid-In
|
Accumulated
|
Treasury
|
|||||||||||||||||||||
Shares Issued
|
Amount
|
Capital
|
Deficit
|
Stock
|
Total
|
|||||||||||||||||||
Balance
at December 31, 2005
|
59,283,960 | $ | 59,284 | $ | 131,790,932 | $ | (122,362,616 | ) | $ | (2,279,238 | ) | $ | 7,208,362 | |||||||||||
Common
stock and warrants issued in connection with private
placements
|
10,650,795 | 10,651 | 12,393,709 | — | — | 12,404,360 | ||||||||||||||||||
Issuance
of stock options/warrants for services and licenses
|
149,928 | 150 | 1,930,098 | — | — | 1,930,248 | ||||||||||||||||||
Options
and warrants exercised
|
703,903 | 704 | 358,489 | — | — | 359,193 | ||||||||||||||||||
Deemed
dividend
|
— | — | 488,429 | (488,429 | ) | — | — | |||||||||||||||||
Net
loss
|
— | — | — | (16,751,824 | ) | — | (16,751,824 | ) | ||||||||||||||||
Balance
at December 31, 2006
|
70,788,586 | 70,789 | 146,961,657 | (139,602,869 | ) | (2,279,238 | ) | 5,150,339 | ||||||||||||||||
Common
stock and warrants issued in connection with private
placements
|
8,615,000 | 8,615 | 34,239,442 | — | — | 34,248,057 | ||||||||||||||||||
Issuance
of stock options/warrants for services and licenses
|
— | — | 2,402,035 | — | — | 2,402,035 | ||||||||||||||||||
Options
and warrants exercised
|
10,994,281 | 10,994 | 18,778,180 | — | — | 18,789,174 | ||||||||||||||||||
Issuance
of stock options by subsidiary
|
— | — | 1,524,377 | — | — | 1,524,377 | ||||||||||||||||||
Net
loss
|
— | — | — | (21,889,943 | ) | — | (21,889,943 | ) | ||||||||||||||||
Balance
at December 31, 2007
|
90,397,867 | $ | 90,398 | $ | 203,905,691 | $ | (161,492,812 | ) | $ | (2,279,238 | ) | $ | 40,224,039 | |||||||||||
Issuance
of stock options/warrants for services and licenses
|
— | — | 2,029,209 | — | — | 2,029,209 | ||||||||||||||||||
Options
and warrants exercised
|
1,006,402 | 1,006 | 975,782 | — | — | 976,788 | ||||||||||||||||||
Common
stock issued in connection with the acquisition of
Innovive
|
2,574,179 | 2,574 | 2,339,832 | — | — | 2,342,406 | ||||||||||||||||||
Deemed
dividend for anti-dilution adjustment
|
— | — | 756,954 | (756,954 | ) | — | — | |||||||||||||||||
Dividend
of RXi stock
|
— | — | — | (2,828,014 | ) | — | (2,828,014 | ) | ||||||||||||||||
Net
loss
|
— | — | — | (27,046,121 | ) | — | (27,046,121 | ) | ||||||||||||||||
Balance
at December 31, 2008
|
93,978,448 | $ | 93,978 | $ | 210,007,468 | $ | (192,123,901 | ) | $ | (2,279,238 | ) | $ | 15,698,307 |
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,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (27,046,121 | ) | $ | (21,889,943 | ) | $ | (16,751,824 | ) | |||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||||||
Depreciation
and amortization
|
624,980 | 272,229 | 227,704 | |||||||||
Retirement
of fixed assets
|
262 | — | — | |||||||||
Non-cash
earned on short-term investments
|
(48,452 | ) | (172,055 | ) | — | |||||||
Loss
on retirement of equipment
|
— | — | 2,864 | |||||||||
Minority
interest in loss of subsidiary
|
(88,374 | ) | (448,671 | ) | — | |||||||
Equity
in loss of unconsolidated subsidiary
|
3,915,514 | — | — | |||||||||
Non-cash
gain on transfer of RXi common stock
|
(226,579 | ) | — | — | ||||||||
Non-cash
expense on the acquisition of Innovive’s in-process research and
development
|
8,012,154 | — | — | |||||||||
Stock
option and warrant expense
|
2,103,752 | 3,511,541 | 1,284,032 | |||||||||
Common
stock issued for services
|
244,860 | 3,089,639 | 262,500 | |||||||||
Non-cash
stock compensation related to research and development
|
— | — | 411,530 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Accounts
receivable
|
238,131 | 4,713 | 66,930 | |||||||||
Income
taxes recoverable
|
(215,623 | ) | — | — | ||||||||
Prepaid
expenses and other current assets
|
478,965 | (1,214,836 | ) | 100,295 | ||||||||
Accounts
payable
|
(1,181,116 | ) | 757,086 | 139,530 | ||||||||
Deferred
revenue
|
(6,166,151 | ) | (7,241,919 | ) | 22,533,467 | |||||||
Accrued
expenses and other current liabilities
|
(56,146 | ) | 978,388 | 1,082,557 | ||||||||
Total
adjustments
|
7,636,177 | (463,885 | ) | 26,111,409 | ||||||||
Net
cash provided by (used in) operating activities
|
(19,409,944 | ) | (22,353,828 | ) | 9,359,585 | |||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
(purchase) from sale of short-term investments
|
10,000,000 | (9,779,493 | ) | — | ||||||||
Deconsolidation
of subsidiary
|
(10,359,278 | ) | — | — | ||||||||
Cash
outlay in the acquisition of Innovive, relating to its accounts
payable
|
(5,669,749 | ) | — | — | ||||||||
Purchases
of equipment and furnishings
|
(994,326 | ) | (1,269,313 | ) | (41,133 | ) | ||||||
Net
cash used in investing activities
|
(7,023,353 | ) | (11,048,806 | ) | (41,133 | ) | ||||||
Cash
flows from financing activities:
|
||||||||||||
Net
proceeds from exercise of stock options and warrants
|
976,808 | 18,789,173 | 359,191 | |||||||||
Net
proceeds from issuances of common stock
|
— | 34,248,058 | 12,404,360 | |||||||||
Capital
contributions from minority interest
|
— | 482,271 | — | |||||||||
Net
cash provided by financing activities
|
976,808 | 53,519,502 | 12,763,551 | |||||||||
Net
increase (decrease) in cash and cash equivalents
|
(25,456,489 | ) | 20,116,868 | 22,082,003 | ||||||||
Cash
and cash equivalents at beginning of year
|
50,498,261 | 30,381,393 | 8,299,390 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 25,041,772 | $ | 50,498,261 | $ | 30,381,393 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
received during the years for interest received
|
$ | 1,203,629 | $ | 2,491,487 | $ | 996,647 | ||||||
Cash
paid during the years for income taxes
|
$ | 1,093,764 | $ | 183,461 | $ | — | ||||||
Supplemental
disclosures of non-cash investing activities:
|
||||||||||||
Fair
market value of options and warrants provided for goods and
services
|
$ | — | $ | — | $ | 705,794 | ||||||
Acquisition
of property and equipment through accrued liabilities
|
$ | 130,955 | $ | 233,974 | $ | — | ||||||
The
accompanying notes are an integral part of these consolidated financial
statements. See supplemental information on the following
page.
F-5
Supplemental
schedule of non-cash investing and financing activities:
CytRx
purchased all of the common stock of Innovive Pharmaceuticals, Inc. in a
transaction that for accounting purposes is considered an asset
acquisition. See Note 17 below. The fair value of
Innovive’s assets and liabilities at September 19, 2008, in millions of dollars,
are presented below:
In-process
research and development
|
$ | 8.0 | ||
Leasehold
interests
|
0.1 | |||
Prepaid
expenses
|
0.3 | |||
Accounts
payable
|
(6.1 | ) | ||
Net
assets acquired through issuance of common stock
|
$ | 2.3 | ||
As a
result of the March 6, 2008 distribution by CytRx Corporation (the “Company”) to
its stockholders of approximately 36% of the outstanding shares of RXi
Pharmaceuticals Corporation, the Company deconsolidated that previously
majority-owned subsidiary. As part of the transaction, the Company
deconsolidated $3.7 million of total assets and $4.6 million of total
liabilities.
In
connection with applicable antidilution adjustments to the price of certain
outstanding warrants in March 2008, the Company recorded a deemed dividend of
approximately $756,954 in the current year. The deemed dividend was recorded as
a charge to accumulated deficit and a corresponding credit to additional paid-in
capital. The Company recorded a deemed dividend of $488,429 under the same
circumstances in March 2006.
During
2007, the Company allocated $289,254 of additional paid in capital arising from
subsidiary common stock options issued to minority interest.
F-6
CYTRX CORPORATION
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1.
Nature of Business
CytRx
Corporation (“CytRx” or the “Company”) is a biopharmaceutical research and
development company engaged in the development of high-value human therapeutics.
CytRx’s drug development pipeline includes two product candidates in clinical
development for cancer indications, including registration studies of
tamibarotene for the treatment of acute promyelocytic leukemia, or APL. In
addition to its core oncology programs, the Company is developing treatments for
neurodegenerative and other disorders based upon its small-molecule molecular
chaperone amplification technology. CytRx is also engaged in new-drug discovery
research at its laboratory facility in San Diego, California, utilizing its
master chaperone regulator assay, or MaCRA, technology. Apart from its drug
development programs and new-drug discovery research activities, CytRx maintains
a 45% equity interest in RXi Pharmaceuticals Corporation, or RXi (NASDAQ:
RXII).
On
September 19, 2008, CytRx completed its merger acquisition of Innovive
Pharmaceuticals, Inc., or Innovive, and its clinical-stage oncology product
candidates, including tamibarotene. As a result of the merger, Innovive became a
wholly owned subsidiary of CytRx. On December 30, 2008, CytRx merged the
former Innovive subsidiary into CytRx. Prior to its acquisition of
Innovive, CytRx was focused on developing human therapeutics based primarily
upon its small-molecule molecular chaperone amplification technology, including
arimoclomol for ALS and iroxanadine for diabetic foot ulcers and other potential
indications. After acquiring Innovive, CytRx redirected its efforts
to developing Innovive’s former lead oncology product candidates, tamibarotene
for APL and INNO-206 for small cell lung cancer, SCLC, and other solid tumor
cancers, which the Company believes hold greater near-term revenue
potential. CytRx’s current business strategy is to seek one or more
strategic partnerships for the further development of arimoclomol and
iroxanadine.
At
December 31, 2008, the Company had cash, cash equivalents and short-term
investments of $25.0 million. Management believes that CytRx’s current resources
will be sufficient to support its currently planned level of operations through
the first quarter of 2010. This estimate is based, in part, upon the Company’s
currently projected expenditures for 2009 of approximately $22 million,
including approximately $7.1 million for its clinical program for tamibarotene,
approximately $3.4 million for its clinical program for INNO-206, approximately
$0.6 million for its clinical program for INNO-406, approximately $0.5 million
for its animal toxicology studies and related activities for arimoclomol,
approximately $1.8 million for operating our clinical programs, approximately
$2.7 million for research activities at its laboratory in San Diego, California,
and approximately $5.9 million for other general and administrative
expenses. Projected expenditures are based upon numerous assumptions
and subject to many uncertainties, and the Company’s actual expenditures may be
significantly different from these projections. The Company will be required to
obtain additional funding in order to execute its long-term business plans,
although it does not currently have commitments from any third parties to
provide it with capital. The Company cannot assure that additional funding will
be available on favorable terms, or at all. If the Company fails to obtain
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. For example, the
Company intends to assess periodically the costs and potential commercial value
of our new-drug discovery activities. Depending on these assessments, the
Company may determine to modify, out-source, partner or suspend these
activities.
2.
Summary of Significant Accounting Policies
Basis of Presentation and Principles
of Consolidation — Through February 2008, the Company owned a majority of
the outstanding shares of common stock of RXi, which was founded in April 2006
by the Company and four researchers in the field of RNAi, including Dr. Craig
Mello, recipient of the 2006 Nobel Prize for Medicine for his co-discovery of
RNAi. RNAi is a naturally occurring mechanism for the regulation of gene
expression that has the potential to selectively inhibit the activity of any
human gene. RXi is focused solely on developing and commercializing therapeutic
products based upon RNAi technologies for the treatment of human diseases,
including neurodegenerative diseases, cancer, type 2 diabetes and obesity. While
RXi was majority-owned, the Company’s consolidated financial statements
reflected 100% of the assets and liabilities and results of operations of RXi,
with the interests of the minority shareholders of RXi recorded as “minority
interests.” In March 2008, the Company distributed to its stockholders
approximately 36% of RXi’s outstanding shares, which reduced CytRx’s ownership
to less than 50% of RXi. As a result of the reduced ownership, CytRx began to
account for its investment in RXi using the equity method, under which CytRx
records only its pro-rata share of the financial results of RXi as “equity in
loss of unconsolidated subsidiary” on the consolidated statements of operations
(see Note 9 below). Because only a portion of RXi’s financial results for 2008
were recorded by CytRx under the equity method, the Company’s results of
operations for the year ended December 31, 2008 are not directly comparable to
results of
F-7
operations
for the same period in 2007. The future results of operations of the Company
also will not be directly comparable to corresponding periods in prior years
during which our financial statements reflected the consolidation of
RXi.
Revenue Recognition — Revenue
consists of license fees from strategic alliances with pharmaceutical companies
as well as service and grant revenues. Service revenue consists of contract
research and laboratory consulting. Grant revenue consist of government and
private grants.
Monies
received for license fees are deferred and recognized ratably over the
performance period in accordance with Staff Accounting Bulletin (“SAB”) No. 104,
Revenue Recognition. Milestone payments will be recognized upon achievement of
the milestone as long as the milestone is deemed substantive and we have no
other performance obligations related to the milestone and collectability is
reasonably assured, which is generally upon receipt, or recognized upon
termination of the agreement and all related obligations. Deferred revenue
represents amounts received prior to revenue recognition.
Revenue
from contract research and consulting fees are recognized over the respective
contract periods as the services are performed, provided there is persuasive
evidence or an arrangement, the fee is fixed or determinable and collection of
the related receivable is reasonably assured. In the case of government grants,
once all conditions of the grant are met and no contingencies remain
outstanding, the revenue is recognized as grant fee revenue and an earned but
unbilled revenue receivable is recorded.
In August
2006, we received approximately $24.3 million in proceeds from the
privately-funded ALS Charitable Remainder Trust (“ALSCRT”) in exchange for the
commitment to continue research and development of arimoclomol and other
potential treatments for ALS and a one percent royalty in the worldwide sales of
arimoclomol. Under the arrangement, we retain the rights to any products or
intellectual property funded by the arrangement and the proceeds of the
transaction are non-refundable. The ALSCRT has no obligation to provide any
further funding to us. We have concluded that due to the research and
development components of the transaction, it is properly accounted for under
Statement of Financial Accounting Standards No. 68, Research and Development Arrangements.
Accordingly, we have recorded the value received under the arrangement as
deferred service revenue and will recognize service revenue using the
proportional performance method of revenue recognition, meaning that service
revenue is recognized on a dollar-for-dollar basis for each dollar of expense
incurred for the research and development of arimoclomol and other potential ALS
treatments. We believe that this method best approximates the efforts expended
related to the services provided. We adjust our estimates of expense incurred
for this research and development on a quarterly basis.
The
amount of “deferred revenue, current portion” is the amount of deferred revenue
that is expected to be recognized in the next twelve months and is subject to
fluctuation based upon management’s estimates. Management’s estimates include an
evaluation of what pre-clinical and clinical trials are necessary, the timing of
when trials will be performed and the estimated clinical trial expenses. These
estimates are subject to changes and could have a significant effect on the
amount and timing of when the deferred revenues are recognized.
Other Income — In March 2008,
the Company recognized a non-cash gain of $0.2 million on the transfer of some
RXi common stock to certain employees. In June 2007, the Company recognized $1.5
million of income arising from a fee received pursuant to a change-in-control
provision included in the purchase agreement for its 1998 sale of its animal
pharmaceutical unit.
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.
Fair Value of Financial Instruments
— The carrying amounts reported in the balance sheet for cash and cash
equivalents approximate their fair values.
Short-term Investments — RXi
has purchased zero coupon U.S Treasury Bills at a discount. These securities
mature within the next twelve months. They are classified as held-to-maturity
and under Statement of Financial Accounting Standards No. 115, Investments in Debt
Securities, are measure at amortized cost since RXi has the intent and
ability to hold these securities to maturity. The interest income has been
amortized at the effective interest rate.
Equipment and Furnishings —
Equipment and furnishings are stated at cost and depreciated using the
straight-line method based on the estimated useful lives (generally three to
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
F-8
when
events and circumstances indicate that the assets might be impaired and the
non-discounted 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.
Molecular Library—The
Molecular library, a collection of chemical compounds that the Company believes
may be developed into drug candidates, are stated at cost and depreciated over
five years; the estimated useful life of the molecular library, which is less
than the remaining life of the related patents. The molecular library is
presently used as a tool in the Company’s drug discovery program. On an annual
basis, or whenever there is a triggering event that might suggest an impairment,
management evaluates the realizability of the molecular library to determine
whether its carrying value has 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 non-discounted 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.
Fair Value Measurements—The
Company adopted Financial Accounting Standards Board Statement of Financial
Accounting Standards No. 157, Fair Value Measurements
(“SFAS 157”), effective January 1, 2008. SFAS 157 does not require
any new fair value measurements; instead it defines fair value, establishes a
framework for measuring fair value in accordance with existing generally
accepted accounting principles and expands disclosure about fair value
measurements. The adoption of SFAS 157 for our financial assets and
liabilities did not have an impact on our financial position or operating
results. Beginning January 1, 2008, assets and liabilities recorded
at fair value in consolidated balance sheets are categorized based upon the
level of judgment associated with the inputs used to measure the fair
value. Level inputs, as defined by SFAS 157, are as
follows:
·
|
Level
1 – quoted prices in active markets for identical assets or
liabilities.
|
·
|
Level
2 – other significant observable inputs for the assets or liabilities
through corroboration with market data at the measurement
date.
|
·
|
Level
3 – significant unobservable inputs that reflect management’s best
estimate of what market participants would use to price the assets or
liabilities at the measurement
date.
|
The
following table summarizes fair value measurements by level at December 31, 2008
for assets and liabilities measured
at fair
value on a recurring basis (in thousands):
Level I
|
Level II
|
Level III
|
Total
|
|||||||||||||
Cash
and cash equivalents
|
$
|
25,042
|
$
|
—
|
$
|
—
|
$
|
25,042
|
Impairment of Long-Lived Assets
— The Company reviews 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.
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
from the patents is uncertain. Patent costs are therefore expensed as
incurred.
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 and warrants) 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 15.2 million shares, 17.1 million shares and 30.2 million
shares at December 31, 2008, 2007 and 2006, respectively.
As a
result of the March 6, 2008 distribution by CytRx to its stockholders of
approximately 36% of the outstanding shares of RXi Pharmaceuticals Corporation,
the Company recorded a deemed dividend of approximately $757,000. In
connection with the Company’s adjustment to the exercise terms of certain
outstanding warrants to purchase common stock on March 2, 2006, the Company
recorded a deemed dividend of $488,000. These deemed dividends are reflected as
an adjustment to net loss for the first
F-9
quarter
of 2008 and the first quarter of 2006 to arrive at net loss applicable to common
stockholders on the consolidated statement of operations and for purposes of
calculating basic and diluted earnings per shares.
Shares Reserved for Future Issuance
— As of December 31, 2008, the Company has reserved approximately 0.7
million of its authorized but unissued shares of common stock for future
issuance pursuant to its employee stock option plans issued to consultants and
investors.
Stock-based Compensation —
Prior to January 1, 2006, the Company accounted for its stock based compensation
plans under the recognition and measurement provisions of Accounting Principles
Board No. 25, Accounting for Stock Issued to Employees (“APB 25”), and related
interpretations for all awards granted to employees. Under APB 25, when the
exercise price of options granted to employees under these plans equals the
market price of the common stock on the date of grant, no compensation expense
is recorded. When the exercise price of options granted to employees under these
plans is less than the market price of the common stock on the date of grant,
compensation expense is recognized over the vesting period.
The
Company’s share-based employee compensation plans are described in Note 13. On
January 1, 2006, the Company adopted SFAS 123(R), “Accounting for Stock-based
Compensation (Revised 2004)” (“123(R)”), which requires the measurement and
recognition of compensation expense for all share-based payment awards made to
employees, non-employee directors, and consultants, including employee stock
options. SFAS 123(R) supersedes the Company’s previous accounting under APB 25
and SFAS 123, for periods beginning in fiscal 2006. In March 2005, the
Securities and Exchange Commission issued SAB 107 relating to SFAS 123(R). The
Company has applied the provisions of SAB 107 in its adoption of SFAS
123(R).
The
Company adopted SFAS 123(R) using the modified prospective transition method,
which requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s fiscal year 2006. The Company’s Statement of
Operations as of and for the years ended December 31, 2006, 2007 and 2008
reflects the impact of SFAS 123(R). In accordance with the modified prospective
transition method, the Company’s Statements of Operations for prior periods have
not been restated to reflect, and do not include, the impact of SFAS 123(R).
Share-based compensation expense recognized under SFAS 123(R) for the years
ended December 31, 2008, 2007 and 2006 was $2.1 million, $2.7 million and $1.2
million, respectively. As of December 31, 2008, there was $2.1 million of
unrecognized compensation cost related to unvested employee stock options that
is expected to be recognized as a component of the Company’s operating expenses
through 2010. Compensation costs will be adjusted for future changes in
estimated forfeitures.
For stock
options paid in consideration of services rendered by non-employees, the Company
recognizes compensation expense in accordance with the requirements of SFAS No.
123(R) and EITF 96-18, as amended, and Emerging Issues Task Force Issue No.
96-18, “Accounting for Equity Instruments that are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”
Under SFAS No. 123(R), the compensation associated with stock options paid to
non-employees is generally recognized in the period during which services are
rendered by such non-employees. Since its adoption of SFAS 123(R), there been no
change to its equity plans or modifications of its outstanding stock-based
awards.
Deferred
compensation for non-employee option grants that do not vest immediately upon
grant are recorded as an expense over the vesting period of the underlying stock
options. At the end of each financial reporting period prior to vesting, the
value of these options, as calculated using the Black Scholes option pricing
model, will be re-measured using the fair value of the Company’s common stock
and deferred compensation and the non-cash compensation recognized during the
period will be adjusted accordingly. Since the fair market value of options
granted to non-employees is subject to change in the future, the amount of the
future compensation expense is subject to adjustment until the stock options are
fully vested. The Company recognized ($403,000) and $1.5 million, respectively,
of stock based compensation expense related to non-employee stock options in
2008 and 2007.
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, including licenses, that are utilized in research and
development and that have no alternative future use are expensed when incurred.
Technology developed for use in its products is expensed as incurred until
technological feasibility has been established.
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 Company’s 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.
F-10
Concentrations of Credit Risk
— Financial instruments that potentially subject the Company to
significant concentrations of credit risk consist principally of cash, cash
equivalents and short-term investments. The Company maintains cash and cash
equivalents in large well-capitalized financial institutions and the Company’s
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 or cash equivalent or its short-term
investments.
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. Significant estimates include the accrual for
research and development expenses, the basis for the classification of current
deferred revenue, estimated income taxes and the estimate of expense arising
from the common stock options granted to employees and non-employees. Actual
results could materially differ from those estimates.
Reclassifications — Certain
prior year balances have been reclassified to conform with the 2008
presentation, with no change in net loss for prior periods
presented.
Other comprehensive income/(loss)
— The Company follows the provisions of Statement of Financial Accounting
Standards (“SFAS”) No. 130, “Reporting Comprehensive Income,” which requires
separate representation of certain transactions, which are recorded directly as
components of shareholders’ equity. The Company has no components of other
comprehensive income (loss) and accordingly comprehensive loss is the same as
net loss reported.
3.
Recent Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
(“SFAS”) No. 157, Fair Value
Measurements (“SFAS No. 157”). SFAS No. 157 defines fair value,
establishes a framework for measuring fair value in accordance with generally
accepted accounting principles, and expands disclosures about fair value
measurements. SFAS No. 157 does not expand the use of fair value in any new
circumstances. In February 2008, the FASB issued Staff Position No. FAS 157-1,
which amended SFAS No. 157 to exclude SFAS No. 13, Accounting for Leases, and
other accounting pronouncements that address fair value measurements for
purposes of lease classification or measurement under Statement 13. However,
this scope exception does not apply to assets acquired and liabilities assumed
in a business combination. Also in February 2008, the FASB issued Staff Position
No. FAS 157-2, which delayed the effective date of SFAS No. 157 for
non-financial assets and liabilities, except those items recognized at fair
value on an annual or more frequently recurring basis to fiscal years beginning
after November 15, 2008 and interim periods within those fiscal years. In
October 2008, the FASB issued Staff Position No. 157-3, to clarify the
application of SFAS No. 157 when the market for a financial asset is inactive.
The Company adopted SFAS No. 157 with no material impact on the Company’s
consolidated financial statements.
In
February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and Financial
Liabilities (“SFAS No. 159”). SFAS No. 159 permits entities to choose to
measure many financial assets and financial liabilities at fair value.
Unrealized gains and losses on items for which the fair value option has been
elected are reported in earnings. SFAS No. 159 is effective for fiscal years
beginning after November 15, 2007. The Company adopted SFAS No. 159 with no
material impact on the Company’s consolidated financial statements.
In June
2007, the FASB ratified the consensus on Emerging Issues Task Force (“EITF”)
Issue No. 06-11, Accounting
for Income Tax Benefits of Dividends on Share-Based Payment Awards
(“EITF 06-11”). EITF 06-11 requires companies to recognize the income tax
benefit realized from dividends or dividend equivalents that are charged to
retained earnings and paid to employees for non-vested equity-classified
employee share-based payment awards as an increase to additional paid-in
capital. EITF 06-11 is effective for fiscal years beginning after September 15,
2007. The Company adopted EITF 06-11 with no material impact on the Company’s
consolidated financial statements.
In June
2007, the FASB ratified the consensus reached on EITF Issue No. 07-3, Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities (“EITF 07-3”), which requires that
nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities be deferred and
amortized over the period that the goods are delivered or the related services
are performed, subject to an assessment of recoverability. EITF 07-3 is
effective for fiscal years beginning after December 15, 2007. The Company
adopted EITF 07-3 with no material impact on the Company’s consolidated
financial statements.
F-11
In
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests
in Consolidated Financial
Statements (“SFAS No. 160”) and a revision to SFAS No. 141, Business Combinations (“SFAS
No. 141R”). SFAS No. 160 modifies the accounting for noncontrolling interest in
a subsidiary and the deconsolidation of a subsidiary. SFAS No. 141R establishes
the measurements in a business combination of the identifiable assets acquired,
the liabilities assumed and any noncontrolling interest in the acquiree. Both of
these related statements are effective for fiscal years beginning after December
15, 2008. The Company will adopt SFAS No. 160 and SFAS No. 141R with no expected
material impact on its consolidated financial statements.
In
December 2007, the SEC issued Staff Accounting Bulletin 110 (“SAB 110”), which
expresses the views of the Staff regarding use of a “simplified” method, as
discussed in SAB 107, in developing an estimate of expected term of “plain
vanilla” share options in accordance with Statement of Financial Accounting
Standards No. 123. SAB 110 will allow, under certain circumstances, the use of
the simplified method beyond December 31, 2007 when an issuer is unable to rely
on the historical exercise data. The Company adopted SAB 110 with no material
impact on its financial statements.
In March
2008, the FASB issued Statement of Financial Accounting Standards No. 161, Disclosures about Derivative
Instruments and Hedging Activities (“SFAS No. 161”). The new
standard amends Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Instruments and Hedging Activities (“SFAS 133”), and seeks to enhance
disclosure about how and why a company uses derivatives; how derivative
instruments are accounted for under SFAS 133 (and the interpretations of that
standard); and how derivatives affect a company’s financial position, financial
performance and cash flows. SFAS 161 will be effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008. Early application of the standard is encouraged, as well as
comparative disclosures for earlier periods at initial adoption. The
Company does not believe adoption of this standard will have a material effect
on its financial statements.
In April
2008, the FASB issued Staff Position No. FAS 142-3, Determination of the Useful Life of
Intangible Assets, which amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of
a recognized intangible asset under FASB Statement No. 142, “Goodwill and Other Intangible
Assets.” The Position will be effective for fiscal years
beginning after December 15, 2008 and will only apply prospectively to
intangible assets acquired after the effective date. Early adoption
is not permitted. The Company does not believe adoption of this standard will
have a material effect on its financial statements.
In May
2008, the FASB issued Staff Position No. Accounting Principles Board 14-1, Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement) (“FSP No. APB 14-1”). FSP No. APB 14-1 requires
that the liability and equity components of convertible debt instruments that
may be settled in cash upon conversion (including partial cash settlement) be
separately accounted for in a manner that reflects an issuer’s nonconvertible
debt borrowing rate. FSP No. APB 14-1 will be effective for us as of
January 1, 2009. The Company does not believe adoption of this
principle will have a material effect on its financial statements.
In May
2008, the FASB issued Statement of Financial Accounting Standards No.
162, The Hierarchy of
Generally Accepted Accounting Principles, (“SFAS 162”), which imposes the
GAAP hierarchy on the reporting entities, not their auditors, based on the
long-standing mandate that the entity's management, not their auditors, is
responsible for selecting and applying the appropriate GAAP to their financial
statements. The auditors' responsibility is to comply with GAAS as a basis for
issuing their audit opinion. In issuing SFAS 162, the FASB does not expect a
change in current practice and The Company does not believe adoption of this
standard will have any impact on its financial statements.
4.
Accounts Receivable
At
December 31, 2008 and 2007, the Company had accounts receivable of $127,280 and
$101,217, respectively, primarily related annual licensing fees due to the
Company. Due to the certainty of the collectability of the accounts receivable,
no allowance was recorded.
5.
Other Assets
At
December 31, 2008 and 2007, the Company had approximately $330,032 and $713,398,
respectively, of non-current other assets, which consist primarily of security
deposits on contracts for research and development, prepaid insurance and leases
for its facilities.
F-12
6.
Equipment, Furnishings and Molecular Library, net
Equipment,
furnishings and molecular library, net, at December 31, 2008 and 2007 consist of
the following (in thousands):
2008
|
2007
|
|||||||
Equipment
and furnishings
|
$ | 2,606 | $ | 1,965 | ||||
Less
— accumulated depreciation
|
(771 | ) | (392 | ) | ||||
Equipment
and furnishings, net
|
1,835 | 1,573 | ||||||
Molecular
library
|
$ | 447 | $ | 447 | ||||
Less
— accumulated amortization
|
(343 | ) | (253 | ) | ||||
Molecular
library, net
|
$ | 104 | $ | 194 |
The
molecular library was purchased in 2004 and placed in service by the Company in
March 2005. The molecular library is being amortized over 60 months, which is
less than the estimated effective life of the patents. The Company will incur
related amortization of approximately $89,000 in 2009 and $16,000 in
2010.
Depreciation
and amortization expense for the years ended December 31, 2008, 2007 and 2006
were $625,000, $272,000 and $228,000, respectively.
7.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities at December 31, 2008 and 2007 are
summarized below (in thousands).
2008
|
2007
|
|||||||
Professional
fees
|
$ | 531 | $ | 907 | ||||
Research
and development costs
|
1,662 | 873 | ||||||
Wages,
bonuses and employee benefits
|
196 | 1,255 | ||||||
Income
taxes
|
— | 30 | ||||||
Other
|
168 | 636 | ||||||
Total
|
$ | 2,557 | $ | 3,701 |
8.
Commitments and Contingencies
The
Company acquires assets still in development and enters into research and
development arrangements with third parties that often require milestone and
royalty payments to the third party contingent upon the occurrence of certain
future events linked to the success of the asset in development. Milestone
payments may be required, contingent upon the successful achievement of an
important point in the development life-cycle of the pharmaceutical product
(e.g., approval of the product for marketing by a regulatory agency). If
required by the arrangement, CytRx may have to make royalty payments based upon
a percentage of the sales of the pharmaceutical product in the event that
regulatory approval for marketing is obtained. Because of the contingent nature
of these payments, they are not included in the table of contractual
obligations.
These
arrangements may be material individually, and in the unlikely event that
milestones for multiple products covered by these arrangements were reached in
the same period, the aggregate charge to expense could be material to the
results of operations in any one period. In addition, these arrangements often
give CytRx the discretion to unilaterally terminate development of the product,
which would allow CytRx to avoid making the contingent payments; however, CytRx
is unlikely to cease development if the compound successfully achieves clinical
testing objectives.
F-13
CytRx’s
current contractual obligations that will require future cash payments are as
follows:
Non-Cancelable
|
||||||||||||||||||||
Operating
Leases (1)
|
Employment
Agreements (2)
|
Subtotal
|
Research
and
Development (3)
|
Total
|
||||||||||||||||
2009
|
$ | 521 | $ | 1,610 | $ | 2,131 | $ | 1,758 | $ | 3,889 | ||||||||||
2010
|
376 | — | 376 | 49 | 425 | |||||||||||||||
2011
|
253 | — | 253 | 49 | 302 | |||||||||||||||
2012
|
124 | — | 124 | 149 | 273 | |||||||||||||||
2013 and
thereafter
|
— | — | — | 532 | 532 | |||||||||||||||
Total
|
$ | 1,274 | $ | 1,610 | $ | 2,884 | $ | 2,537 | $ | 5,421 |
____________
(1)
|
Operating
leases are primarily facility lease related obligations, as well as
equipment and software lease obligations with third party
vendors.
|
(2)
|
Employment
agreements include management contracts, which have been revised from time
to time, provide for minimum salary levels, adjusted annually at the
discretion of the Company’s Compensation Committee, as well as for minimum
bonuses that are payable.
|
(3)
|
Research
and development obligations relate primarily to clinical trials. Most of
these purchase obligations are
cancelable.
|
The
Company applies the disclosure provisions of FASB Interpretation No. (“FIN”) 45,
“Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others” (“FIN 45”), to its agreements
that contain guarantee or indemnification clauses. The Company provides (i)
indemnifications of varying scope and size to certain investors and other
parties for certain losses suffered or incurred by the indemnified party in
connection with various types of third-party claims; and (ii) indemnifications
of varying scope and size to officers and directors against third party claims
arising from the services they provide to us. These indemnifications and
guarantees give rise only to the disclosure provisions of FIN 45. To date, the
Company has not incurred material costs as a result of these obligations and
does not expect to incur material costs in the future; further, the Company
maintains insurance to cover certain losses arising from these indemnifications.
Accordingly, the Company has not accrued any liabilities in its consolidated
financial statements related to these indemnifications or
guarantees.
9.
Equity Transactions
On March
11, 2008, the Company paid a dividend to its stockholders of approximately 36%
of the outstanding shares of RXi common stock. In connection with that dividend,
the Company adjusted the price of warrants to purchase approximately 10.6
million shares that had been issued in prior equity financings in October 2004,
January 2005 and March 2006. The adjustments were made as a result of
anti-dilution provisions in those warrants that were triggered by the Company’s
distribution of a portion of its assets to its stockholders. The Company
accounted for the anti-dilution adjustments as deemed dividends analogous with
the guidance in Emerging Issues Task Force Issue (“EITF”) No. 98-5, Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratios, and EITF 00-27, Application of 98-5 to Certain
Convertible Instruments, and recorded a charge of
approximately $757,000 to accumulated deficit and a corresponding credit to
additional paid-in capital.
On April
19, 2007, the Company completed a $37.0 million private equity financing in
which we issued 8.6 million shares of its common stock at $4.30 per share. Net
of investment banking commissions, legal, accounting and other expenses related
to the transaction, the Company received approximately $34.2 million of
proceeds.
On March
2, 2006, the Company completed a $13.4 million private equity financing in which
it issued 10,650,795 shares of its common stock and warrants to purchase an
additional 5,325,397 shares of its common stock at an exercise price of $1.54
per share. Net of investment banking commissions which included 745,556 warrants
to purchase CytRx common stock at $1.54 per share, legal, accounting and other
expenses related to the transaction, the Company received approximately $12.4
million of proceeds.
In
connection with the March 2006 financing, the Company adjusted the price and
number of underlying shares of warrants to purchase approximately 2.8 million
shares that had been issued in prior equity financings in May and September
2003. The adjustment was made as a result of anti-dilution provisions in those
warrants that were triggered by the Company’s issuance of common stock in that
financing at a price below the closing market price on the date of the
transaction. The Company accounted for the anti-dilution
F-14
adjustments
as deemed dividends analogous with the guidance in Emerging Issues Task Force
Issues (“EITF”) No. 98-5, Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratios, and EITF 00-27, Application of 98-5 to Certain
Convertible Instruments, recorded an approximate $488,000 charge to
retained earnings and a corresponding credit to additional paid-in
capital.
In
connection with the March 2006 private equity financing, the Company entered
into a registration rights agreement with the purchasers of its stock and
warrants, which provides among other things, for cash penalties in the event
that the Company was unable to initially register, or maintain the effective
registration of the securities. The Company initially evaluated the penalty
provisions in light of EITF 00-19, Accounting for Derivative Financial Instruments
Indexed To, and Potentially Settled In a Company’s Own Stock, and
determined that the maximum penalty does not exceed the difference between the
fair value of a registered share of CytRx common stock and unregistered share of
CytRx common stock on the date of the transaction. The Company then evaluated
the provisions of FASB Staff Position No. EITF 00-19-2, Accounting for Registration
Payment Arrangements, which specifies that the contingent obligation to
make future payments or otherwise transfer consideration under a registration
payment arrangement should be separately recognized and measured in accordance
with FASB Statement No. 5, Accounting for Contingencies,
pursuant to which a contingent obligation must be accrued only if it is more
likely than not to occur. In management’s estimation, the contingent payments
related to the registration payment arrangement are not likely to occur, and
thus no amount need be accrued. The Company has elected to reflect early
adoption of FSP 00-19-2 in its 2006 financial statements, and the adoption did
not have an effect on its financial statements.
10.
Minority Interest in RXi
Through
February 2008, the Company owned approximately 85% of the outstanding shares of
common stock of RXi. While RXi was majority-owned, the Company’s consolidated
financial statements reflected 100% of the assets and liabilities and results of
operations of RXi, with the interests of the minority shareholders of RXi
recorded as “minority interests.” The Company offset $88,375 of minority
interest in losses of RXi against its net loss for the months of January and
February 2008, and $448,671 of minority interest in losses of RXi against its
net loss for year ended December 31, 2007.
On March
11, 2008, the Company distributed to its stockholders approximately 4.5 million
shares of RXi common stock, or approximately 36% of RXi’s outstanding shares,
which reduced CytRx’s ownership to less than 50% of RXi. As a result, CytRx
began to account for its investment in RXi using the equity method, under which
CytRx records only its pro-rata share of the financial results of RXi. Because
only a portion of RXi’s financial results for 2008 were recorded by CytRx under
the equity method, the Company’s results of operations for 2008 are not directly
comparable to results of operations for 2007. The future results of operations
of the Company also will not be directly comparable to corresponding periods in
prior years during which our financial statements reflected the consolidation of
RXi.
11.
Equity Investment in RXi
Management
determined that the distribution of RXi common stock to stockholders of CytRx in
March 2008 represented a partial spin-off of RXi and accounted for the
distribution of the RXi common shares at cost. As a result of its reduced
ownership in RXi, CytRx began to account for its investment in RXi using the
equity method, under which CytRx records only its pro-rata share of the
financial results of RXi. The following table presents summarized financial
information for RXi for the year ended December 31, 2008:
Income Statement Data (unaudited, in
thousands)
|
Year Ended December 31,
2008
|
|||
Sales
|
$ | — | ||
Gross
profit
|
— | |||
Loss
from continuing operations
|
(14,553 | ) | ||
Net
Loss
|
(14,373 | ) |
Balance Sheet Data (unaudited, in
thousands)
|
December 31, 2008
|
|||
Current
assets
|
$ | 9,929 | ||
Noncurrent
assets
|
430 | |||
Current
liabilities
|
1,387 | |||
Stockholders’
equity
|
8,968 |
F-15
At
December 31, 2008, the fair value of CytRx’s 6,268,881 shares of RXi common
stock was $36.0 million based on the closing price of RXi common stock (NASDAQ:
RXII) on that date. As CytRx accounts for its investment in RXi using the equity
method, this value it not reflected in the “Investment in affiliates – RXi
Pharmaceuticals” on the CytRx balance sheet.
12.
Stock Options and Warrants
CytRx
Options
The
Company has a 2000 Long-Term Incentive Plan under which an aggregate of
10,000,000 shares of common stock were originally reserved for
issuance. As of December 31, 2008, there were approximately 7.1
million shares subject to outstanding stock options and approximately 0.7
million shares available for future grant under the plan. Options granted under
this plan generally vest and become exercisable as to 33% of the option grants
on each anniversary of the grant date until fully vested. The options will
expire, unless previously exercised, not later than ten years from the grant
date. The Company also has a 1994 Stock Option Plan and a 1998 Long Term
Incentive Plan under which 9,167 shares and 27,500 shares, respectively, were
subject to outstanding stock options. However, no options are available for
future grant under either of these plans.
On
November 21, 2008, the Company’s board of directors adopted the 2008 Stock
Incentive Plan, which will be submitted for approval by the Company’s
stockholders at the 2009 Annual Meeting of stockholders. In the meantime, the
Company may make awards under the 2008 Plan, the effectiveness of which are
conditioned upon obtaining such stockholder approval. At December 31, 2008,
there were 350,000 shares subject to outstanding options awarded under the 2008
Plan and 9,650,000 shares available for future awards.
The fair
value of the stock options at the date of grant was estimated using the
Black-Scholes option-pricing model, based on the following
assumptions:
2008
|
2007
|
2006
|
||||||||||
Weighted
average risk free interest rate
|
2.68 | % | 4.41 | % | 4.91 | % | ||||||
Dividend
yields
|
0 | % | 0 | % | 0 | % | ||||||
Weighted
average volatility
|
102 | % | 108 | % | 112 | % | ||||||
Expected
lives (years)
|
6 | 6 | 6 |
The
Company’s computation of expected volatility is based on the historical daily
volatility of its publicly traded stock. For option grants issued during the
years ended December 31, 2008, 2007 and 2006, the Company used a calculated
volatility for each grant. The Company’s computation of expected lives were
estimated using the simplified method provided for under Staff Accounting
Bulletin 107, Share-Based
Payment (“SAB 107”), which averages the contractual term of the Company’s
options of ten years with the average vesting term of three years for an average
of six and a half years. The dividend yield assumption of zero is based upon the
fact the Company has never paid cash dividends and presently has no intention of
paying cash dividends. The risk-free interest rate used for each grant is equal
to the U.S. Treasury rates in effect at the time of the grant for instruments
with a similar expected life. Based on historical experience, for the years
ended December 31, 2008, 2007 and 2006, the Company has estimated an annualized
forfeiture rate for each period of 10% for options granted to its employees, 3%
and 1%, respectively, for options granted to senior management and 0%
for each period for options granted to directors. Compensation costs will be
adjusted for future changes in estimated forfeitures. The Company will record
additional expense if the actual forfeitures are lower than estimated and will
record a recovery of prior expense if the actual forfeiture rates are higher
than estimated. No amounts relating to employee stock-based compensation have
been capitalized.
F-16
At
December 31, 2008, there remained approximately $2.1 million of unrecognized
compensation expense related to unvested employee stock options to be recognized
as expense over a weighted-average period of 2.2 years. Presented below is the
Company’s stock option activity:
Stock Options
|
Weighted Average Exercise Price
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
Outstanding
— beginning of year
|
4,932,273 | 4,500,208 | 4,097,542 | $ | 2.46 | $ | 1.66 | $ | 1.70 | |||||||||||||||
Granted
|
2,021,500 | 1,685,500 | 783,500 | 0.79 | 4.02 | 1.36 | ||||||||||||||||||
Exercised
|
(54,737 | ) | (1,030,932 | ) | (82,500 | ) | 0.92 | 1.76 | 0.97 | |||||||||||||||
Forfeited
|
(473,096 | ) | (222,503 | ) | (296,667 | ) | 2.08 | 1.24 | 1.59 | |||||||||||||||
Expired
|
(16,000 | ) | — | (1,667 | ) | 1.00 | — | 1.00 | ||||||||||||||||
Outstanding
— end of year
|
6,409,940 | 4,932,273 | 4,500,208 | 1.99 | 2.46 | 1.66 | ||||||||||||||||||
Exercisable
at end of year
|
4,109,839 | 3,210,320 | 3,316,994 | $ | 2.07 | $ | 1.93 | $ | 1.84 | |||||||||||||||
Weighted
average fair value of stock options granted during the
year:
|
$ | 0.63 | $ | 3.34 | $ | 1.16 |
A summary
of the activity for unvested employee stock options as of December 31, and
changes during the year is presented below:
Stock Options
|
Weighted
Average
Grant
Date Fair
Value per Share
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
Nonvested
at January 1,
|
1,721,952 | 1,183,214 | 1,736,553 | $ | 2.92 | $ | 0.99 | $ | 1.16 | |||||||||||||||
Granted
|
2,021,500 | 1,685,500 | 783,500 | 0.63 | 3.34 | 1.16 | ||||||||||||||||||
Vested
|
(970,256 | ) | (924,259 | ) | (1,040,172 | ) | 2.10 | 1.67 | 1.29 | |||||||||||||||
Pre-vested
forfeitures
|
(473,096 | ) | (222,503 | ) | (296,667 | ) | 1.74 | 1.06 | 1.39 | |||||||||||||||
Nonvested
at December 31,
|
2,300,100 | 1,721,952 | 1,183,214 | $ |
1.52
|
$ | 2.92 | $ | 0.99 |
The
following table summarizes significant ranges of outstanding stock options under
the three plans at December 31, 2008:
Range
of Exercise Prices
|
Number of Options
|
Weighted
Average Remaining
Contractual
Life(years)
|
Weighted
Average Exercise Price
|
Number
of Options
Exercisable
|
Weighted
Average Contractual Life
|
Weighted
Average Exercise Price
|
||||||||||||||||||||
$ | 0.35 — 1.00 | 1,780,412 | 8.29 | $ | 0.58 | 878,937 | 8.29 | $ | 0.76 | |||||||||||||||||
$ | 1.01 — 2.00 | 1,994,004 | 7.34 | 1.39 | 1,328,829 | 7.34 | 1.44 | |||||||||||||||||||
$ | 2.01 — 3.00 | 1,120,499 | 4.57 | 2.46 | 1,102,499 | 4.57 | 2.46 | |||||||||||||||||||
$ | 3.01 — 4.00 | 530,025 | 8.71 | 3.43 | 301,693 | 8.71 | 3.40 | |||||||||||||||||||
$ | 4.01 — 4.65 | 985,000 | 8.35 | 4.42 | 497,881 | 8.35 | 4.43 | |||||||||||||||||||
6,409,940 | 7.39 | $ | 1.99 | 4,109,839 | 7.39 | $ | 2.07 |
There was
no aggregate intrinsic value of outstanding options as of December 31, 2008,
since there is no difference between the closing fair market value of the
Company’s common stock on December 31, 2008 ($0.30) and the exercise price of
the underlying options.
For stock
options paid in consideration of services rendered by non-employees, the Company
recognizes compensation expense in accordance with the requirements of SFAS No.
123(R), Emerging Issues Task Force Issue No. 96-18 (“EITF 96-18”), Accounting for Equity Instruments
that are Issued to other than Employees for Acquiring, or in Conjunction with
Selling Goods or Services and EITF 00-18, Accounting Recognition for Certain
Transactions involving Equity Instruments Granted to Other Than Employees, as
amended.
Non-employee
option grants that do not vest immediately upon grant are recorded as an expense
over the vesting period. At the end of each financial reporting period prior to
performance, the value of these options, as calculated using the Black-Scholes
option-pricing model, is determined, and compensation expense recognized or
recovered during the period is adjusted accordingly. Since the fair market value
of options granted to non-employees is subject to change in the future, the
amount of the future compensation expense is subject to adjustment until the
common stock options are fully vested.
F-17
The
Company recorded approximately ($0.4) million, $0.4 million and $1.3 million of
non-cash charges related to the issuance of stock options to certain consultants
in exchange for services during 2008, 2007 and 2006, respectively. In January
2007, the Company’s RNAi operations (RXi Pharmaceuticals Corporation) began
operating on a stand-alone basis (see “Our Separation from RXi Pharmaceuticals
Corporation” on page 10 for further details). Except for approximately $0.2
million, the non-cash charges for services incurred during 2006 relate primarily
to the RXi operations and are discussed more fully in the “RXi Options” section
that follows on page F-19.
At
December 31, 2008, there remained approximately $0.1 million of unrecognized
compensation expense related to unvested non-employee stock options to be
recognized as expense over a weighted-average period of 4 years. Presented below
is the Company’s non-employee stock option activity:
Stock Options
|
Weighted Average Exercise Price
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
Outstanding
— beginning of year
|
1,067,000 | 2,358,000 | 2,108,000 | $ | 1.44 | $ | 1.66 | $ | 1.74 | |||||||||||||||
Granted
|
350,000 | — | 250,000 | 0.35 | — | 1.11 | ||||||||||||||||||
Exercised
|
— | (728,500 | ) | — | — | 1.86 | — | |||||||||||||||||
Forfeited
|
(402,000 | ) | (562,500 | ) | — | 1.85 | 1.85 | — | ||||||||||||||||
Expired
|
(20,000 | ) | — | — | 0.30 | — | — | |||||||||||||||||
Outstanding
— end of year
|
995,000 | 1,067,000 | 2,358,000 | 0.91 | 1.44 | 1.67 | ||||||||||||||||||
Exercisable
at end of year
|
445,000 | 817,000 | 1,441,447 | $ | 1.18 | $ | 1.54 | $ | 1.68 | |||||||||||||||
Weighted
average fair value of stock options granted during the
year:
|
$ | 0.33 | $ | 0 | $ | 0.95 |
The fair
value of the stock options at the date of grant was estimated using the
Black-Scholes option-pricing model, based on the following
assumptions:
2008
|
2007
|
2006
|
||||||||||
Weighted
average risk free interest rate
|
2.68 | % | — | 4.31 | % | |||||||
Dividend
yields
|
0 | % | — | 0 | % | |||||||
Weighted
average volatility
|
123 | % | — | 108 | % | |||||||
Expected
lives (years)
|
10 | — | 6 |
A summary
of the activity for nonvested, non-employee stock options as of December 31, and
changes during the years are presented below:
Stock Options
|
Weighted Average Grant
Date
Fair Value per Share
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Nonvested
at January 1,
|
250,000 | 916,663 | $ | 1.00 | $ | 1.44 | ||||||||||
Granted
|
350,000 | — | 0.33 | — | ||||||||||||
Vested
|
(50,000 | ) | (104,163 | ) | 0.33 | 1.63 | ||||||||||
Pre-vested
forfeitures
|
— | (562,500 | ) | — | 1.63 | |||||||||||
Nonvested
at December 31,
|
550,000 | 250,000 | $ | 0.58 | $ | 1.00 |
F-18
CytRx
Warrants
A summary
of the Company’s warrant activity and related information for the years ended
December 31 are shown below.
Warrants
|
Weighted Average Exercise Price
|
|||||||||||||||||||||||
2008
|
2007
|
2006
|
2008
|
2007
|
2006
|
|||||||||||||||||||
Outstanding
— beginning of year
|
13,031,515 | 23,360,165 | 18,508,949 | $ | 1.87 | $ | 1.83 | $ | 1.94 | |||||||||||||||
Granted
|
— | — | 6,112,870 | — | — | 1.54 | ||||||||||||||||||
Exercised
|
(951,665 | ) | (10,233,650 | ) | (1,261,654 | ) | 0.97 | 1.77 | 1.16 | |||||||||||||||
Forfeited
|
— | — | — | — | — | — | ||||||||||||||||||
Expired
|
(1,445,002 | ) | (95,000 | ) | — | 2.60 | 2.25 | — | ||||||||||||||||
Outstanding
— end of year
|
10,634,848 | 13,031,515 | 23,360,165 | 1.40 | 1.87 | 1.83 | ||||||||||||||||||
Exercisable
at end of year
|
10,634,848 | 13,031,515 | 23,360,165 | $ | 1.40 | $ | 1.87 | $ | 1.83 | |||||||||||||||
Weighted
average fair value of warrants granted during the year:
|
$ | — | $ | — | $ | 1.54 |
The
following table summarizes additional information concerning warrants
outstanding and exercisable at December 31, 2008:
Warrants Outstanding
|
||||||||||||||||||||||
Range of Exercise Prices
|
Number
of Shares
|
Weighted
Average
Remaining
Contractual
Life (years)
|
Weighted Average
Exercise Price
|
Warrants
Number
of Shares
Exercisable
|
Exercisable
Weighted
Average Exercise Price
|
|||||||||||||||||
$ | 1.16 — 1.28 | 3,907,569 | 2.03 | $ | 1.20 | 3,907,569 | $ | 1.20 | ||||||||||||||
$ | 1.51 — 1.62 | 6,701,790 | 1.04 | 1.51 | 6,701,790 | 1.51 | ||||||||||||||||
$ | 1.84 — 2.67 | 25,489 | 2.71 | 2.41 | 25,489 | 2.41 | ||||||||||||||||
10,634,848 | 1.41 | $ | 1.40 | 10,634,848 | $ | 1.40 |
RXi
Pharmaceuticals Options
RXi has
its own stock option plan. While RXi was a consolidated subsidiary, the Company
accounted for RXi stock options in the same manner as for CytRx stock options as
described above.
As
discussed in Note 12, the Company started accounting for its investment in RXi
under the equity method in March 2008, and accordingly, the following table sets
forth the total stock-based compensation expense for January and February 2008
resulting from RXi stock options that is included in the Company’s unaudited
condensed consolidated statements of operations:
Years Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Research
and development — employee
|
$ | 28,000 | $ | 120,000 | ||||
General
and administrative — employee
|
369,000 | 931,000 | ||||||
Total
employee stock-based compensation
|
$ | 397,000 | $ | 1,051000 | ||||
Research
and development — non-employee
|
$ | 121,000 | $ | 1,043,000 | ||||
General
and administrative — non-employee
|
— | — | ||||||
Total
non-employee stock-based compensation
|
$ | 121,000 | $ | 1,043,000 |
13.
Stockholder Protection Rights Plan
Effective
April 16, 1997, the Company’s board of directors declared a distribution of one
right (“Rights”) for each outstanding share of the Company’s 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 Company’s then outstanding
shares of common stock (a “Flip-in Date”).
F-19
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 Right’s 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 Company’s stockholders from coercive
or abusive takeover tactics and to give the Board of Directors more negotiating
leverage in dealing with prospective acquirors. In April 2007, the Company
extended the stockholder rights plan through April 2017.
14.
Income Taxes
The
Company will recognize approximately a $32.9 million gain for income tax
purposes on its distribution of shares of RXi common stock, which is the amount
equal to the excess of the fair market value of the stock distributed over the
Company’s basis.
At
December 31, 2008, the Company had United States federal and state net operating
loss carryforwards of $91.4 million and $56.9 million, respectively, available
to offset against future taxable income, which expire in 2011 through 2028. As a
result of a change in-control that occurred in the CytRx shareholder base in
July 2002, approximately $47.5 million in federal net operating loss
carryforwards became limited in their availability to $0.3 million annually.
Management currently believes that the remaining $43.9 million in federal net
operating loss carryforwards, and the $56.3 million in state net operating loss
carryforwards, are unrestricted. However, management is reviewing its recent
equity transactions to determine if they may have resulted in any further
restrictions on the Company’s net operating loss carryforwards. Additionally,
due to the change-in-control, approximately $6.3 million of research and
development tax credits will not be available for utilization and were written
off. As of December 31, 2008, CytRx also had research and development and
alternative minimum tax credits for federal and state purposes of approximately
$3.9 million and $3.1 million, respectively, available for offset against future
income taxes, which expire in 2023 through 2028. Based on an assessment of all
available evidence including, but not limited to, the Company’s limited
operating history in its core business and lack of profitability, uncertainties
of the commercial viability of its technology, the impact of government
regulation and healthcare reform initiatives, and other risks normally
associated with biotechnology companies, the Company has 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.
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 Company’s
deferred tax assets and liabilities, all of which are long-term, are as follows
(in thousands):
December 31,
|
||||||||
2008
|
2007
|
|||||||
Deferred
tax assets:
|
||||||||
Net
operating loss carryforwards
|
$ | 34,407 | $ | 39,919 | ||||
Tax
credit carryforwards
|
6,071 | 3,114 | ||||||
Equipment,
furnishings and other
|
4,358 | 4,124 | ||||||
Deferred
revenue
|
3,744 | 6,200 | ||||||
Total
deferred tax assets
|
48,580 | 53,357 | ||||||
Deferred
tax liabilities
|
(407 | ) | (111 | ) | ||||
Net
deferred tax assets
|
48,173 | 53,246 | ||||||
Valuation
allowance
|
(48,173 | ) | (53,246 | ) | ||||
$ | — | $ | — |
For all
years presented, the Company did not recognize any deferred tax assets or
liabilities. The net change in valuation allowance for the years ended December
31, 2008 and 2007 was ($5,073,000) and $9,416,000,
respectively.
F-20
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):
Years ended December 31,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
Federal
benefit at statutory rate
|
$ | (8,899 | ) | $ | (7,781 | ) | $ | (5,646 | ) | |||
State
income taxes, net of Federal taxes
|
(1,525 | ) | (908 | ) | (968 | ) | ||||||
Permanent
differences
|
16,272 | 65 | 143 | |||||||||
Provision
related to change in valuation allowance
|
(5,073 | ) | 9,416 | 34 | ||||||||
Net
change in research and development tax credits
|
(2,207 | ) | (1,125 | ) | 5,059 | |||||||
Other,
net
|
2,304 | 373 | (637 | ) | ||||||||
$ | 872 | $ | 40 | $ | 145 |
15.
Quarterly Financial Data (unaudited)
Summarized
quarterly financial data for 2008 and 2007 is as follows (in thousands, except
per share data):
Quarters Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
(In
thousands, except per share data)
|
||||||||||||||||
2008
|
||||||||||||||||
Total
revenues
|
$ | 2,181 | $ | 1,740 | $ | 917 | $ | 1,428 | ||||||||
Net
loss
|
(5,374 | ) | (5,826 | ) | (12,316 | ) | (3,530 | ) | ||||||||
Deemed
dividend for anti-dilution adjustments made to outstanding
common
stock warrants
|
(757 | ) | — | — | — | |||||||||||
Net
loss applicable to common stockholders
|
$ | (6,131 | ) | $ | (5,826 | ) | $ | (12,316 | ) | $ | (3,530 | ) | ||||
Basic
and diluted loss per share applicable to common stock
|
$ | (0.07 | ) | $ | (0.06 | ) | $ | (0.14 | ) | $ | (0.04 | ) | ||||
2007
|
||||||||||||||||
Total
revenues
|
$ | 1,563 | $ | 2,371 | $ | 2,046 | $ | 1,479 | ||||||||
Net
loss
|
(4,546 | ) | (6,285 | ) | (4,597 | ) | (6,462 | ) | ||||||||
Deemed
dividend for anti-dilution adjustments made to outstanding
common
stock warrants
|
— | — | — | — | ||||||||||||
Net
loss applicable to common stockholders
|
$ | (4,546 | ) | $ | (6,285 | ) | $ | (4,597 | ) | $ | (6,462 | ) | ||||
Basic
and diluted loss per share applicable to common stock
|
$ | (0.06 | ) | $ | (0.07 | ) | $ | (0.05 | ) | $ | (0.07 | ) |
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.
Our
Statements of Operations as of and for the years ended December 31, 2008 and
2007 reflect the impact of SFAS 123(R). Share-based compensation expense
recognized under SFAS 123(R) for the years ended December 31, 2008 and 2007 were
$2.1 and $2.7 million, respectively.
In
connection with the Company’s adjustment to the exercise terms of certain
outstanding warrants to purchase common stock on March 11, 2008, the Company
recorded deemed dividends of $757,000. These deemed dividends are reflected as
an adjustment to net loss for the first quarter of 2008 to arrive at net loss
applicable to common stockholders on the consolidated statements of operations
and for purposes of calculating basic and diluted earnings per
shares.
Fourth
Quarter Adjustment
During
the fourth quarter of 2007, the Company recorded adjustments for: (i) additional
compensation expense of $236,000 related to previously granted non-employee
stock options, (ii) additional compensation expense of $350,000 related to stock
options previously granted to Directors and (iii) additional general and
administrative expense of $192,000 related to legal fees rendered during the
third quarter. Management concluded the effect of these adjustments was not
material to any previously reported quarterly period.
F-21
16.
Acquisition of Innovive Pharmaceuticals
On
September 19, 2008, the Company completed the merger of Innovive with CytRx
Merger Subsidiary, Inc., the Company’s wholly owned subsidiary, with Innovive
continuing as the surviving corporation. As a result, Innovive became a wholly
owned subsidiary of CytRx and changed its name to CytRx Oncology Corporation,
which better reflects the nature of the Innovive product candidates acquired in
the transaction. On December 30, 2008, CytRx merged the former
Innovive subsidiary into CytRx.
In the
merger of Innovive with CytRx Merger Subsidiary, Inc., each outstanding share of
Innovive common stock (other than shares owned by Innovive, CytRx and CytRx
Merger Subsidiary, Inc.) was cancelled and converted into the right to receive
initial merger consideration of 0.1762 share of the Company’s common stock (plus
cash in lieu of any fractional CytRx share at a price of $0.94 per share). The
Company issued as the initial merger consideration a total of 2,574,282 CytRx
shares to the former Innovive stockholders. The former Innovive stockholders
also will be entitled to receive up to $1.01 per Innovive share of future
earnout merger consideration, subject to our achievement of specified net sales
under the existing Innovive license agreements. The earnout merger
consideration, if any, will be payable in shares of CytRx common stock, subject
to specified conditions, or, at CytRx’s election, in cash or by a combination of
shares of CytRx common stock and cash. CytRx’s common stock will be valued for
purposes of any future earnout merger consideration based upon the trading price
of CytRx common stock at the time the earnout merger consideration is
paid.
Because
Innovive is a development stage company, under accounting principles generally
accepted in the U.S. and the SEC regulations, it is not considered a
business. Accordingly, CytRx accounted for the merger in accordance
with Statement of Financial Accounting Standards No. 142, Goodwill and Other
Intangible Assets, for transactions other than a business
combination. Management of CytRx has further determined it is not
required to include in this Quarterly Report pro forma financial statements
giving effect to the merger.
The
initial merger consideration, together with direct costs incurred to effect the
merger, were allocated to the individual assets acquired, including identifiable
intangible assets and liabilities assumed based on the relative fair
value. No goodwill was recorded. The Company’s
consolidated financial statements will reflect these fair values and will not be
restated retroactively to reflect the historical financial position or results
of operations of Innovive. In connection with the merger, CytRx recorded a
one-time expense for acquired in-process research and development of
$8,012,514.
Simultaneously
with the signing of the merger agreement in June 2008, CytRx entered into a loan
and security agreement with Innovive pursuant to which the Company agreed to
advance funds to Innovive to be used to pay current accounts payable and accrued
expenses of Innovive until the closing. On the date of the closing of the
transaction, the total advances to Innovive of approximately $3.5 million were
eliminated in the merger accounting and the related $690,000 reserve for
doubtful accounts relating to the loan in the second quarter of 2008 was
reversed.
17.
Subsequent Events
On
January 1, 2009, John Y. Caloz was appointed Chief Financial Officer and
Treasurer.
F-22
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
Board of
Directors and Stockholders
CytRx
Corporation
Los
Angeles, California
We have
audited the accompanying consolidated balance sheets of CytRx Corporation as of
December 31, 2008 and 2007 and the related consolidated statements of
operations, stockholders’ equity, and cash flows for each of the three years in
the period ended December 31, 2008. We have also audited the schedule
listed in the accompanying index under Item 15a (2). These financial statements
and schedule are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An
audit also includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements, assessing the accounting principles
used and significant estimates made by management, 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 at
December 31, 2008 and 2007, and the results of its operations and its cash flows
for each of the three years in the period ended December 31, 2008, in conformity with
accounting principles generally accepted in the United States of
America.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), CytRx Corporation's internal control over
financial reporting as of December 31, 2008, based on criteria established in
Internal Control – Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO) and our report dated March 11, 2009 expressed an
unqualified opinion thereon.
/s/ BDO SEIDMAN, LLP
BDO Seidman, LLP
Los
Angeles, California
March 11,
2009
F-23
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of
Directors and Shareholders
CytRx
Corporation
Los
Angeles, California
We have
audited CytRx Corporation’s internal control over financial reporting as of
December 31, 2008, based on criteria established in Internal Control – Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (the COSO criteria). CytRx Corporation’s management is
responsible for maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control over financial
reporting, included in the accompanying “Item 9A, Controls and Procedures.” Our
responsibility is to express an opinion on the company’s internal control over
financial reporting 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 effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audit also included performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In our
opinion, CytRx Corporation maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2008, based on the
COSO criteria.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the balance sheet of the Company as of December
31, 2008 and 2007, and the related statements of operations, stockholders’
equity, and cash flows for each of the three years in the period ended December
31, 2008 and our report dated March 11, 2009 expressed an unqualified opinion
thereon.
/s/ BDO SEIDMAN, LLP
BDO Seidman, LLP
Los
Angeles, California
March 11,
2009
F-24
CYTRX CORPORATION
SCHEDULE
II — VALUATION AND QUALIFYING ACCOUNTS
For
the Years Ended December 31, 2008, 2007 and 2006
Additions
|
||||||||||||||||||||
Description
|
Balance
at Beginning
of Year
|
Charged
to Costs
and Expenses
|
Charged
to Other
Accounts
|
Deductions
|
Balance
at End of Year
|
|||||||||||||||
Reserve
Deducted in the Balance Sheet from the Asset to Which it
Applies:
|
||||||||||||||||||||
Allowance
for Deferred Tax Assets
|
||||||||||||||||||||
Year
ended December 31, 2008
|
$ | 53,246,000 | $ | — | $ | (5,073,000 | ) | $ | — | $ | 48,173,000 | |||||||||
Year
ended December 31, 2007
|
$ | 43,830,000 | $ | — | $ | 9,416,000 | $ | — | $ | 53,246,000 | ||||||||||
Year
ended December 31, 2006
|
$ | 43,796,000 | $ | — | $ | 34,000 | $ | — | $ | 43,830,000 |
F-25