CYTRX CORP (CYTR)
10-K
Annual report pursuant to section 13 and 15(d)
Filed on 03/11/2011
Filed Period 12/31/2010
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
T
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2010
or
£
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to _______________
Commission file number 0-15327
CytRx Corporation
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
11726 San Vicente Blvd, Suite 650,
Los Angeles, California
(Address of principal executive offices)
58-1642740
(I.R.S. Employer
Identification No.)
90049
(Zip Code)
Registrant’s telephone number, including area code: (310) 826-5648
_____________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, $0.001 par value per share
Series A Junior Participating Preferred Stock Purchase Rights
Name of exchange on which registered
The NASDAQ Capital Market
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 T
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 T No £
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes £ 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. T
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 £
Accelerated filer T
Non-accelerated filer £
Smaller reporting company
£
(Do not check if a smaller reporting
company)
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes £ No T
Based on the closing price of the Registrant’s common stock as reported on The Nasdaq Capital Market, the aggregate market value of the Registrant's
common stock held by non-affiliates on June 30, 2010 (the last business day of the Registrant's most recently completed second fiscal quarter) was
approximately $84.5 million. Shares of common stock held by directors and executive officers and any ten percent or greater stockholders and their
respective affiliates have been excluded from this calculation, because such stockholders may be deemed to be “affiliates” of the Registrant. This is not
necessarily determinative of affiliate status for other purposes. The number of outstanding shares of the Registrant's common stock as of March 11, 2011 was
109,227,169, exclusive of treasury shares.
CYTRX CORPORATION
2010 ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
“SAFE HARBOR” STATEMENT
PART I
Item 1. BUSINESS
Item 1A. RISK FACTORS
Item 2. PROPERTIES
Item 3. LEGAL PROCEEDINGS
PART II
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Item 6. SELECTED FINANCIAL DATA
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTAINS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
Item 9A. CONTROLS AND PROCEDURES
Item 9B. OTHER INFORMATION
PART III
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 11. EXECUTIVE COMPENSATION
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
SIGNATURES
2
Page
3
4
14
23
24
25
27
28
38
38
38
38
39
40
44
61
62
63
64
68
“SAFE HARBOR” STATEMENT
Some of the information contained in this Annual Report may include forward-looking statements that reflect our current views with respect to our
research and development activities, business strategy, business plan, financial performance and other future events. These statements include forward-
looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. 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.
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 this Statement.
3
Item 1. BUSINESS
PART I
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, specializing in
oncology. Our drug development pipeline includes clinical development of three product candidates for cancer indications, including recently-initiated Phase
2 proof-of-concept clinical trials with bafetinib in patients with advanced, hormone-refractory prostate cancer and relapsed or refractory B-cell chronic
lymphocytic leukemia, or B-CLL, an additional planned pharmacokinetic clinical trial with bafetinib in patients with brain cancer, two planned Phase 2
clinical trials for INNO-206 as a treatment for soft tissue sarcomas and pancreatic cancer following an abbreviated safety trial, and clinical trials with
tamibarotene for the treatment of non-small-cell lung cancer and acute promyelocytic leukemia, or APL. In addition to our core oncology programs, we own
rights to two drug candidates based on our molecular chaperone regulation technology, which are designed to repair or degrade mis-folded proteins associated
with disease. Our current business strategy is to seek one or more strategic partnerships to pursue the development of this technology.
We are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles,
California 90049, and our telephone number is (310) 826-5648.
OUR PRODUCT CANDIDATE PIPELINE
The following table summarizes our product candidates and their current or impending stages of development:
Technology
Product Candidate
Indication(s)
Stage of Development
Doxorubicin prodrug
Tyrosine kinase inhibitor
INNO-206
Bafetinib
Synthetic retinoid
Tamibarotene
Soft tissue sarcomas
Pancreatic cancer
B-CLL (B-cell chronic lymphocytic leukemia) Phase II
Phase II
Advanced prostate cancer
Phase I
Brain cancer
Phase IIb
Non-small-cell lung cancer
Pivotal Phase II
APL (acute promyelocytic leukemia)
Phase II (2H11)
Phase II (2H11)
OUR CLINICAL DEVELOPMENT PROGRAMS
Our current clinical development programs are discussed below.
INNO-206
INNO-206 (formerly DOXO-EMCH) is a prodrug of the commonly prescribed chemotherapeutic agent 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 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).
4
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 circulating albumin through the EMCH linker;
circulating albumin preferentially accumulates in tumors, bypassing uptake by other non-tumor sites, including the heart, liver and the
gastrointestinal tract;
once albumin-bound INNO-206 reaches the tumor, the acidic environment of the tumor causes cleavage of the acid sensitive linker; and
free doxorubicin is released at the site of the tumor and is taken up by the cancer cells.
Pre-clinical data. In a variety of preclinical models, INNO-206 was superior to doxorubicin in its ability to increase the total doxorubicin dose,
antitumor efficacy, and safety, including a reduction in cardiotoxicity. Animal studies conducted by INNO-206 inventor Dr. Felix Kratz, Department of
Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, demonstrated statistically significant efficacy against breast,
ovarian, pancreatic and small cell lung cancers growing in immunodeficient mice.
Clinical data. A Phase I study of INNO-206 that demonstrated safety and objective clinical responses in several tumor types was completed in 2005 and
presented at the March 2006 Krebskongress meeting in Berlin. In this study, single doses were administered every 3 weeks at up to six times the standard
dosing of doxorubicin without an increase in side effects over those historically observed with doxorubicin. Twenty-three of 35 evaluable patients had either
an objective clinical (partial) response or stable disease. Objective clinical responses were observed in patients with sarcoma, breast, and small cell lung
cancers.
Development Plan. Based on the objective clinical responses seen in the Phase I study, and preclinical data, two Phase 2 clinical trials are planned to be
initiated for INNO-206 in 2011 in patients with pancreatic cancer and soft tissue sarcomas.
Bafetinib
Bafetinib (formerly INNO-406) is a novel drug developed by the Japanese pharmaceutical company Nippon Shinyaku, to overcome some of the
limitations of Gleevec and other tyrosine kinase inhibitors in resistant chronic myelogenous leukemia, or CML. In 2010, we initiated Phase II clinical trials
with bafetinib as a treatment for B-cell chronic lymphocytic leukemia, or B-CLL, and advanced, hormone-refractory prostate cancer, and a pharmacokinetic
clinical trial with bafetinib in patients with brain cancer, due to the potent and specific inhibitory properties of bafetinib against Lyn and Fyn kinases, which
are overexpressed in those cancers.
Potential Indications for Bafetinib. B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL
are reported in the United States, alone, each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of
placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients in the high-risk B-CLL
classification have a median overall survival period of one to five years.
Prostate cancer is the second most common malignancy and second-leading cause of cancer death among American men, according to the American
Cancer Society. Of those diagnosed, one in 35 men will die of prostate cancer. The National Cancer Institute estimates that more than 217,000 new cases and
more than 32,000 deaths will be attributed to prostate cancer in the U.S. this year. Treatment of the disease can vary significantly from watchful waiting to
surgery, radiation or both, followed by hormonal treatment. Hormonal treatment can shrink the cancer, delay its growth and reduce symptoms; however,
patients with metastatic prostate cancer usually stop responding to this therapy within two years. The disease at this stage, called metastatic hormone-
refractory prostate cancer, is typically treated with chemotherapeutic agents, and patients have a median survival period of less than two years, according to
the National Cancer Institute.
5
Brain tumors can be benign, with no cancer cells, or malignant, with cancer cells that grow quickly. There are two main types of brain cancer. Primary
brain cancer, or glioma, starts in the brain and metastatic brain cancer starts somewhere else in the body and moves to the brain. Gliomas represent
approximately 70% of the 22,500 malignant primary brain tumors diagnosed annually in American adults. Glioblastoma, the most common type of glioma in
adults, is incurable with a median overall survival period of 12-15 months.
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 bafetinib dose of 240 mg twice per day.
The maximum tolerated dose was determined to be 240-360 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 toxicity, 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.
Development Plan. In 2010, we initiated Phase II clinical trials with bafetinib as a treatment for B-cell chronic lymphocytic leukemia (B-CLL) and
advanced, hormone-refractory prostate cancer, and a pharmacokinetic clinical trial with bafetinib in patients with brain cancer.
Our Phase 2 proof-of-concept clinical trial to evaluate the preliminary efficacy and safety of its oncology drug candidate bafetinib in patients with high-
risk B-cell chronic lymphocytic leukemia (B-CLL) was initiated in May 2010. In this clinical trial, high-risk B-CLL patients who have failed treatment with
first-line agents will self-administer oral doses of bafetinib twice daily. The bafetinib dose used in this trial is based on the highest dose that was best tolerated
in the Phase 1 study described above. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival.
Enrollment is expected to be completed 12 to 14 months following initiation of the trial, with potential interim data announcements . The dose of bafetinib
may be escalated to 360 mg twice daily if relatively few side effects are observed at the 240 mg twice daily dose.
In September 2010, we initiated the Prostate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and
safety of bafetinib in patients with advanced prostate cancer. The open-label PROACT trial is being conducted at City of Hope Cancer Center, located just
outside of Los Angeles, California. In the trial, up to 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with
chemotherapy could receive orally available bafetinib at 240 mg twice daily. The trial endpoints are reduction in prostate-specific antibodies and increases in
progression-free survival compared to baseline and historical data. An assessment of response to bafetinib (tumor shrinkage, prostate-specific antigen (PSA)
reduction and stabilization of disease) will occur after the first 21 patients have been treated with bafetinib for three months. The dose of bafetinib may be
escalated to 360 mg twice daily if relatively few side effects are observed at the 240 mg twice daily dose.
In 2010, we also initiated a pharmacokinetic clinical trial with bafetinib in patients with recurrent brain tumors. Results from this trial are expected in the
second quarter of 2011 and will be used in evaluating potential further clinical development of bafetinib in patients with brain cancer. Six to eight patients
with recurrent primary brain cancer or recurrent brain metastases who have undergone brain surgery will be evaluated in the trial, which is being conducted at
City of Hope Cancer Center. The trial's primary objective is to provide neuropharmacokinetic information, such as the ability of bafetinib to cross the
blood:brain barrier and, if so, the percentage that enters the brain compared to the amount in systemic blood.
6
Tamibarotene
Tamibarotene is an orally available, synthetic retinoid rationally 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.
Tamibarotene for the treatment of NSCLC. More than 220,000 new cases of lung cancer occur in the U.S. each year, and more than 1.5 million occur
annually worldwide. Deaths due to lung cancer account for the majority of cancer-related deaths (180,000 in the U.S., 1.35 million worldwide) and the five-
year survival ranges between 8%-15%. Non-small cell-lung cancer, or NSCLC, accounts for 85%-90% of all lung cancers, with subsets adenocarcinoma
representing 35%-40%, squamous cell carcinoma accounting for 25%-30% and large cell carcinoma accounting for 10%-15%.
A recent Phase 2 clinical trial conducted by Arrieta et al. and published in the peer-reviewed Journal of Clinical Oncology (2010; 28: 3463-3471)
compared ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone as a treatment for patients with advanced
NSCLC. The group administered ATRA plus the chemotherapy agents showed improved response rates of 55.8% versus 25.4%, and increased progression-
free survival of 8.9 months versus 6.0 months. Median overall survival was increased from 9.5 months to 23.5 months when ATRA was added to the above
chemotherapy regimen, representing a 14-month median extension of life.
Tamibarotene was developed to overcome resistance to ATRA. In vitro, tamibarotene is approximately ten times more potent than ATRA, and
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 skin
toxicities.
Development Plan. We have initiated a randomized Phase 2b clinical trial, in which patients with stage IIIB (with pleural effusions, or fluid in the chest
cavity) or stage IV NSCLC will be treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of the
clinical trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the study will evaluate
overall survival, quality-of-life and the pharmacokinetics of tamibarotene in this population. The clinical trial, which is expected to enroll approximately 140
patients, is being conducted in several clinical sites in the U.S. and Mexico.
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 RARa 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 anthracycline-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, which occurs in up to 25%
of patients treated with ATRA, is 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.
Pre-clinical data. In 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.
7
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 administered to 42 patients with
APL, 39 of whom were evaluable for response. Patients included individuals 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. There is currently a Special Protocol Assessment (SPA) in place with the FDA for a Phase 2 registration clinical trial, known as
STAR-1, which is evaluating the efficacy and safety of tamibarotene as a third-line treatment for APL. The STAR-1 trial is ongoing and currently includes six
clinical sites in the U.S. We recently reported that, of the 11 patients enrolled in the STAR-1 trial to date, three (27%) achieved a hematologic complete
response, and four (36%) a morphologic leukemia-free state. In addition, in September 2009, we initiated a dose escalation clinical trial with tamibarotene
combined with TRISENOX® (arsenic trioxide) injection (marketed by Cephalon, Inc.) in patients with relapsed APL.
Other Technologies
We own the rights to two drug candidates, arimoclomol and iroxanadine, that are based on our molecular chaperone regulation technology and are
designed to repair or degrade mis-folded proteins associated with disease. Our current business strategy is to seek one or more strategic partnerships to pursue
the development of that technology or an outright sale of the assets, and we have no current plan for our own further development of these drug candidates.
Our other current technologies 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. We currently have no plans for development of these
technologies.
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 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 after March 11, 2008 no longer consolidate the financial condition and results of
operation of RXi, but instead reflect any ongoing investment in RXi based on the equity method of accounting. In 2009, the investment balance in RXi was
reduced to zero, and we stopped recording our share of losses from RXi. On June 30, 2010, we sold 2.0 million common shares of RXi and our ownership in
RXi was reduced to approximately 3.1 million shares of common stock. We thereafter began to account for those shares as available for sale, and increases or
decreases in the value of these shares were included as part of comprehensive income or loss. This investment was shown on the balance sheet at market
value, based on RXi’s closing stock price as reported on The Nasdaq Capital Market. We sold our remaining number of shares of RXi common stock in
December 2010 for approximately $6.9 million.
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.
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.
8
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 our oncology drug candidates, including
INNO-206, bafetinib and tamibarotene, 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.
As of March 11, 2011, our exclusive license to INNO-206 and related technologies includes two granted U.S. and 30 granted foreign patents or allowed
applications, and 2 pending U.S. and 21 pending foreign applications. Patents and applications that cover pharmaceutical compositions of INNO-206,
processes for their production, and their use in treatment methods (e.g., cancer, viral diseases, autoimmune diseases, and acute or chronic inflammatory
diseases) have an unextended patent term until June 2020.
As of March 11, 2011, our exclusive license to bafetinib and related technologies includes two granted U.S. and 25 granted foreign patents or allowed
applications, and 8 pending foreign applications. Patents and applications that cover bafetinib, pharmaceutical compositions of bafetinib, and their use in
treating leukemia have an unextended patent term until June 2023 or December 2024.
As of March 11, 2011, we hold exclusive licenses in two U.S. patents, one Canadian patent, and one European patent application covering various
crystal forms of tamibarotene, pharmaceutical compositions comprising these crystal forms, and methods for their production, as well as pharmaceutical
compositions comprising combinations of tamibarotene with other anti-cancer drugs. These exclusive licenses also cover a general method of producing
tamibarotene and its close analogs and cover certain intermediates related to this production method.
As of March 11, 2011, we hold ownership rights in 11 issued U.S. and 255 granted foreign patents or allowed applications, and seven pending U.S. and
42 pending foreign applications covering arimoclomol and iroxanadine, our proprietary molecular chaperone regulators, and related technologies. Patents that
cover arimoclomol compositions have unextended patent terms until November 2016 or February 2020. Patents covering arimoclomol treatment methods,
including insulin resistance, peripheral nervous system disorders, diabetes, central nervous system disorders (ALS, MS, Parkinson's), vascular and endothelial
disorders, stroke, and diabetic wound healing, extends patent protection through February 2020 to May 2028. Patents covering iroxanadine compositions
have unextended patent terms until August 2017, or until December 2019 for (-)-iroxanadine enantiomeric compositions. Patents that cover iroxanadine
treatment methods, including vascular and endothelial disorders, central nervous system disorders (ALS, MS, Parkinson's), stroke, and diabetic wound healing
extend patent protection through August 2017 to May 2028. Our molecular chaperone patent portfolio also includes three issued U.S. patents, 43 granted
foreign patents, one pending U.S. application, and five pending foreign applications with unextended patent term until November 2016 which cover additional
aspects of molecular chaperone technology.
9
LICENSE AGREEMENTS
INNO-206
We have an 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 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 are party to an 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;
10
•
•
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 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.
Tamibarotene
We have agreements with TMRC for the license of patent rights held by TMRC for North American and European 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 and NSCLC. 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 certain other cancers.
Under the agreement for North American rights, 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 agreements, 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 and Europe that we determine are commercially feasible.
The agreements 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 or Europe, as applicable, 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.
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
INNO-206 is a prodrug of doxorubicin, a widely used anti-cancer drug. Doxorubicin is part of the anthracycline class of chemotherapy
agents. Anthracyclines, many of which are generic including doxorubicin, have been used throughout the world to treat various cancers for several
decades. Due to their track record of broad anti-cancer activity, new types of anthracyclines and modified or reformulated versions continue to be developed
to overcome toxicities which limit the use of these drugs.
INNO-206 is a chemically modified version of doxorubicin that incorporates an acid sensitive linker technology to improve targeting to the tumor. 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 targeted carrier will allow for higher dosing and greater efficacy.
Soft tissue sarcoma patients are typically treated with surgery followed by radiation therapy. Doxorubicin is the only approved drug for treating soft
tissue sarcoma and is often used in combination with radiation. The National Comprehensive Cancer Network also includes the use of ifosfamide, epirubicin,
Eli Lilly’s Gemzar, dacarbazine and liposomal doxorubicin marketed in the U.S. as Doxil by Johnson & Johnson. For patients ineligible for surgery, radiation
and/or chemotherapy is the only option. Other approaches to treating soft tissue sarcoma are in late stage clinical development. These include ridaforolimus
being developed by Ariad Pharmaceuticals and Merck & Co., Cell Therapeutics’ brostallicin, GlaxoSmithKline’s pazopanib, Sanofi-Aventis’ AVE8062,
Threshhold Pharmaceuticals’ TH-302, trabectedin being co-developed by Johnson and Johnson and PharmaMar and ZIOPHARM Oncology’s palifosfamide.
11
Pancreatic cancer patients are typically treated with surgery, radiation and chemotherapy. Eli Lilly’s Gemzar is currently approved for the first line
treatment of locally advanced or metastatic pancreatic cancer. It is also indicated for the use in patients who have received prior treatment with 5-FU. OSI
Pharmaceuticals’ Tarceva was approved in 2005 for the use in combination with Gemzar. The NCCN believes the best management for these patients is in a
clinical trial. Because of the tremendous unmet need for these patients, many companies are developing new drugs to treat pancreatic cancer. Late stage
drugs in clinical trials include Abraxane by Abraxis BioScience, AGS-1C4D4 by Astellas Pharma Inc., and TS-1 by Taiho Pharmaceutical Co.
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.
Non-small-cell lung cancer, or NSCLC, is a competitive indication in which patients are treated with a variety of agents. The standard regimen for first-
line locally advanced or metastatic NSCLC is a doublet comprised of a platinum agent combined with a taxane, vinka alkaloid or antimetabolite. The addition
of Genentech/Roche’s Avastin to the standard treatment doublet has resulted significant improvements in survival and rates of remission. Tarceva by OSI and
Genentech/Roche and Iressa by AstraZeneca have shown benefit in second-line regimens for specific patients but have not conferred survival benefit. In
addition, there are several drugs in late-stage development including Eisai’s eribulin, Eli Lilly & Co.’s necitumumab and Pfizer’s axitinib and crizotinib.
There are currently three marketed competitors to bafetinib (formerly INNO-406) in the CML market, Gleevec®, Sprycel® and Tasigna Gleevec is
approved for treatment of newly diagnosed adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase
and patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy. Sprycel® and
Tasigna® are approved for Gleevec-resistant CML and have recently been approved for the treatment of newly diagnosed adult patients with Ph+ CML.
Because of the highly competitive nature of the CML market including drug candidates in development, we plan to develop bafetinib initially in cancers other
than CML. We selected B-CLL, hormone refractory prostate cancer and brain cancer due to the potent and specific inhibitory properties of bafetinib against
Lyn and Fyn kinases. Lyn and Fyn kinases are members of the Src family of kinases which are known to be involved in cell growth. Lyn and Fyn kinases are
overexpressed in advanced prostate cancer and glioblastoma multiforme (GBM), the most common form of brain cancer. Lyn kinase is overexpressed in B-
CLL.
There are several drugs approved for the treatment of CLL. First-line therapy for CLL includes a variety of combination therapies including fludarabine,
cyclophosphamide, Rituxan® and Campath®. Treatment for relapsed or refractory CLL includes several chemotherapy regimens including CHOP, CFAR,
hyperCFAD and OFAR in addition to single agents including GlaxoSmithKline’s ArzerraTM and Sanofi-Aventis’ OfortaTM. Arzerra was approved in
October 2009 for CLL patients who are refractory to treatment with fludarabine and Campath. Oforta, an oral tablet formulation of fludarabine, was approved
in December 2008 as a second-line treatment for CLL.
There are products currently under development by other companies and organizations that could compete with bafetinib in advanced prostate cancer.
Products such as chemotherapeutics, androgen metabolism or androgen receptor antagonists, endothelin A receptor antagonists, antisense compounds,
angiogenesis inhibitors and gene therapies for cancer are also under development by a number of companies as well. Sanofi-Aventis’ Taxotere® (docetaxel)
Injection Concentrate was approved by the FDA in 2004 for the therapeutic treatment of metastatic, androgen-independent prostate cancer. In 2010, the FDA
approved Dendreon’s Provenge (sipuleucel-T) for hormone refractory prostate cancer. In addition, bafetinib may compete with late-stage oral therapies in
development such as Johnson and Johnson’s abiraterone and Medivation’s MDV3100.
Current therapy for glioblastoma multiforme, the most common form of brain cancer, is surgery followed by radiation therapy and chemotherapy.
Merck’s Temodar® is approved for treating newly diagnosed GBM concomitantly with radiotherapy and then as a maintenance treatment. Roche’s Avastin
was approved in May 2009 for treatment of recurrent GBM. We believe that bafetinib’s ability to selectively inhibit Lyn and Fyn kinases and to penetrate the
brain in an animal model of cancer will be an effective treatment for second-line therapy in GBM. Other drugs in development for GBM include Merck
Serono’s cilengitide, Myrexis’ MPC-6827, and Arno Therapeutics’ AR-67.
12
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.
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.
13
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 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, 2011, we had 15 employees, six of whom were engaged in clinical development activities and nine of whom 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
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 a net profit of $0.4 million, including gain from the sale of RXi shares and other marketable
securities, for the year ended December 31, 2010, and net losses of $4.8 million and $27.0 million for the years ended December 31, 2009 and 2008,
respectively. We had an accumulated deficit as of December 31, 2010 of approximately $196.5 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 do not become profitable or are unable to maintain future profitability, the market value
of our common stock will be adversely affected.
14
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 February 18, 2011 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 August 17, 2011,
the closing bid price of our common stock is at or above $1.00 for 10 consecutive business days and we otherwise meet the Nasdaq's continuing listing
requirements. In its notice to us, 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 Capital
Market, we expect prices for our common stock to be quoted on the Pink Sheets LLC or the OTC Bulletin Board. There is no assurance, however, that prices
for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would thereafter exist,
which would materially and adversely impact the market value of our common stock.
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, sales of our shares of RXi common stock, 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;
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 $0.1 million, $9.5 million and $6.3 million, respectively, for the years ended December 31, 2010, 2009, and 2008. Our revenues in
2009 and 2008 included $9.4 million and $6.2 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 to the privately-funded ALS Charitable Remainder Trust, or ALSCRT. Pursuant to an
amendment signed between us and the beneficiary of the ALSCRT on August 6, 2009, we were released from all restrictions on the use of any proceeds
previously paid to us in connection with the arrangement. As a result, we recognized $6.7 million as service revenue in the third quarter of 2009, which
represented the remaining deferred revenue and previously un-recognized portion of the value received. 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, 2010, we had cash and cash equivalents of approximately $6.3 million, marketable securities of $20.6 million and proceeds from sale
of the balance of RXi shares of $6.9 million. Management believes that our current resources will be sufficient to fund our operations for the foreseeable
future. The belief is based, in part, upon our currently projected expenditures for 2011 of approximately $20.1 million, which includes approximately $3.5
million for our clinical programs for INNO-206, approximately $2.2 million for our clinical programs for bafetinib, approximately $5.5 million for our
clinical program for tamibarotene, approximately $2.0 million for general operation of our clinical programs, and approximately $6.8 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.
15
If we obtain marketing approval as currently planned and successfully commercialize our product candidates, we anticipate it will take a minimum of
several years, and likely 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 may be adversely affected by the weak economic recovery in the U.S. 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 estimate, the commercialization of our products may be delayed and our
business prospects may suffer. Our financial projections also may prove to be materially inaccurate.
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 such as the discussion in this Annual Report of the expected timing of certain milestones relating to our INNO-206, bafetinib
and tamibarotene clinical development programs.
We also may disclose projected expenditures or other forecasts for future periods such as the statements above in this Annual Report supplement
regarding our current projected expenditures for fiscal year 2011. 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 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. 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 financial projections.
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 U.S. Food and Drug Administration, or FDA, or corresponding 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;
requirements for clinical trial design imposed by the FDA;
unexpected adverse reactions by patients in trials;
16
•
•
•
•
•
•
difficulty in obtaining clinical supplies of the product;
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.
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 U.S. 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.
Our current and planned clinical trials of our product candidates may fail to show that these product candidates are clinically safe and effective, or
that they are better than alternative treatments.
INNO-206 was no more toxic than free doxorubicin in a Phase I clinical trial and showed limited biological responses against certain tumors. However,
these conclusions may not be reproducible in larger clinical trials, including the planned abbreviated safety clinical trial of INNO-206 and the planned Phase 2
clinical trials of INNO-206 as a treatment for soft tissue sarcomas and pancreatic cancer.
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. However, bafetinib has never been tested in human clinical trials in patients with B-CLL, prostate cancer or brain cancer, and there are no
assurances that it will be effective in those indications.
Tamibarotene has been shown to be safe, well-tolerated, and efficacious in the Japanese APL population. However, it is possible that the response to the
drug may be different in American or European populations. Furthermore, the efficacy studies that led to approval in Japan occurred prior to the advent of the
use of arsenic trioxide, or ATO, for second-line therapy. It is possible that the current use of ATO could alter the safety or efficacy of tamibarotene. The
FDA might not accept the Japanese studies as a database for safety in the U.S.. The majority of patients treated with ATRA as a first-line therapy generally
experience a complete remission of disease. As a result of the limited population of patients requiring third-line treatment for APL, there is no assurance that
we will be successful in recruiting a sufficient number of patients into our ongoing clinical trial of tamibarotene as a third-line treatment for APL in order to
demonstrate efficacy. Any FDA-required changes to our clinical development strategy could delay or increase the cost of the trial, adversely affect our ability
to demonstrate the efficacy of tamibarotene in the trial or cause us not to pursue clinical development of tamibarotene for one or more of these considerations.
Tamibarotene has never been tested in human clinical trials in patients with NSCLC, and there are no assurances that it will be effective in that indication.
Even if our current trials are successful, subsequent trials 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 INNO-206, tamibarotene or bafetinib for any indications.
17
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. 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 INNO-206, bafetinib and tamibarotene. 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 cannot be manufactured at an acceptable cost, the commercial success of our products may be adversely
affected.
We may rely upon third parties in connection with the commercialization of our products.
The completion of the development of INNO-206, bafetinib and tamibarotene, 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 own or have rights to patents and
patent applications directed to INNO-206, tamibarotene and bafetinib, these 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.
18
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 U.S. 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.
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 affected.
19
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,
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,
they are not excluded as immunizations, and
they have been approved by the FDA.
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;
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.
For a more detailed discussion of the competition we face, see “Business – Competition,” above.
We will be required to pay substantial milestone and other payments relating to the commercialization of our products.
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:
20
•
•
•
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.
Our agreement relating to our worldwide (except Japan) rights to 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).
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 $4.4 million upon meeting specified clinical, regulatory and sales milestones up to and including the first commercial sale of
tamibarotene for the treatment of APL.
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.
Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $18.3
million 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.
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 if 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 ongoing clinical
trials, 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 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 our oncology drug candidates, which we
believe has the greatest revenue potential. 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.
21
We may determine to issue shares of our common stock 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 will be diluted accordingly.
Risks Associated with Our Common Stock
Our anti-takeover measures 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.
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 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, 2010, there were outstanding stock options and warrants to purchase approximately 18.9 million shares of our common stock at a
weighted-average exercise price of $1.26 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. 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.
22
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 $0.62 to $1.56 per share since January 1, 2010, 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 continuing poor economy. Despite the recovery in
the U.S. financial markets in 2009, the market remains depressed for private investment in public equity, or 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;
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 do not expect to pay any cash dividends on our common stock.
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
We lease our headquarters in Los Angeles, California. The lease covers approximately 6,240 square feet of office and storage space and expires in
March 2015. This lease requires us to make monthly payments of approximately $24,890, subject to annual increases.
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 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.
23
Item 3. LEGAL PROCEEDINGS
We are occasionally involved in claims arising in the normal course of business. As of March 11, 2011, there were no such claims that we expect,
individually or in the aggregate, to have a material adverse affect on us.
24
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:
Fiscal Year 2010:
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Fiscal Year 2009:
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Holders
High
Low
$
$
$
$
$
$
$
$
1.11
0.97
1.29
1.56
1.29
1.72
1.09
0.45
$
$
$
$
$
$
$
$
0.73
0.62
0.73
1.07
0.71
0.84
0.34
0.24
On March 11, 2011, there were approximately 700 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 holders of our common stock approximately 36% of the outstanding shares of RXi on an approximate 1-for-20 basis.
Equity Compensation Plans
The following table sets forth certain information as of December 31, 2010, regarding securities authorized for issuance under our equity compensation
plans:
Plan Category
Equity compensation plans approved by our security holders:
2000 Long-Term Incentive Plan
2008 Stock Incentive Plan
Equity compensation plans not approved by our security holders:
Outstanding warrants (1)
Total
____________
(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))
7,243,090 $
2,565,500
9,062,074
18,870,664 $
1.08
0.83
1.47
1.26
•
7,434,500
•
7,434,500
(1) 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 one 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.
25
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, 2005 to December 31, 2010. 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, 2005, and that all dividends
were reinvested. This data was furnished by Zacks Investment Research.
Comparison of Cumulative Total Returns
[Missing Graphic Reference]
2006
185.43
110.39
97.87
December 31,
2008
42.29
73.32
95.76
2007
275.72
122.14
102.94
2009
157.89
106.58
107.62
2010
142.41
125.93
116.66
CytRx Corporation
NASDAQ Stock Market Index
NASDAQ Pharmaceutical Index
Recent Issuances of Unregistered Securities
During the three-month period ended December 31, 2010, we issued 50,000 shares of our common stock, and warrants to purchase a total of 800,000
shares of our common stock at exercise prices ranging from $0.87 to $3.50 per share, in connection with a consulting arrangement, and we issued another
40,000 shares of our common stock upon the cashless exercise of a warrant. The issuances of stock and warrants were exempt from registration under the
Securities Act of 1933 pursuant to Section 4(2) of the Securities Act of 1933 and Regulation D under the Act.
Repurchase of Shares
We did not repurchase any of our shares during the year ended December 31, 2010.
26
Item 6. SELECTED FINANCIAL DATA
General
The following selected financial data are derived from our audited financial statements. Our financial statements for 2010, 2009 and 2008 have been
audited by BDO USA, 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.
2010
2009
2008
2007
2006
Statement of Operations Data:
Revenues
Service revenue
Licensing revenue
Grant revenue
Total revenues
Deemed dividend for anti-dilution adjustments made to outstanding common stock
warrants
Net Profit (loss) applicable to common stockholders
Basic and diluted profit (loss) per share applicable to common stock
Balance Sheet Data:
Cash, cash equivalents and marketable securities
Total assets
Total stockholders’ equity
Factors Affecting Comparability
$
$
$
$
100,000
•
• $ 9,400,000 $ 6,166,000 $ 7,242,000 $ 1,859,000
101,000
106,000
100,000 $ 9,500,000 $ 6,266,000 $ 7,459,000 $ 2,066,000
101,000
116,000
100,000
•
100,000
•
•
(488,000)
(757,000)
408,460 $ (4,800,000) $(27,803,000) $(21,890,000) $(17,240,000)
(0.25)
(0.26) $
(0.30) $
(0.05) $
0.00 $
•
•
$26,892,000 $32,643,000 $ 25,042,000 $ 60,450,000 $ 30,381,000
$36,697,000 $35,277,000 $ 28,324,000 $ 64,146,000 $ 31,636,000
$30,568,000 $28,348,000 $ 15,698,000 $ 40,224,000 $ 5,150,000
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
Leasehold interests
Prepaid expenses
Accounts payable
Net assets acquired through issuance of common stock
$
$
8.0
.1
.3
(6.1)
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, 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 of RXi.
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.
In July 2009, we completed a $20.0 million registered direct public offering of approximately 15.3 million shares of our common stock at a price of
$1.31 per share and warrants to purchase an additional approximately 4.7 million shares of common stock at an exercise price of $1.70 per share. Net of
investment banking commissions, advisory fees, legal, accounting and other fees related to the transaction, we received proceeds of approximately $18.3
million (without giving effect to any proceeds that we may receive upon future exercises of the warrants sold in the offering).
27
In April 2007, we completed a $37.0 million private equity financing in which we sold 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 sale proceeds.
In August 2006, we received marketable securities, which were subsequently 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 research and development of arimoclomol and other potential
treatments for ALS and a one percent royalty from worldwide sales of arimoclomol. We recorded the value received under the arrangement as deferred
service revenue, which. we recognize using the proportional performance method of revenue recognition. In August 2009, we were released from all
restrictions on the use of any proceeds previously received by us in connection with the arrangement. As a result, we recognized in the third quarter $6.7
million of service revenue, representing all of the remaining deferred revenue and previously un-recognized portion of the value received in the arrangement
with ALSCRT. During 2009 and 2008, we recognized approximately $9.4 million and $6.2 million, respectively, of service revenue related to this
transaction, respectively.
Our Statements of Operations as of and for the years ended December 31, 2010, 2009 and 2008 reflect the impact of ASC 718 (previously SFAS No.
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, 2010, 2009 and 2008 were $1.6 million, $2.7 million and $2.1 million, respectively. As of December 31, 2010, there was $3.0 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.
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, specializing in
oncology. Our drug development pipeline includes clinical development of three product candidates for cancer indications, including recently-initiated Phase
2 proof-of-concept clinical trials with bafetinib in patients with advanced, hormone-refractory prostate cancer and relapsed or refractory B-cell chronic
lymphocytic leukemia, or B-CLL, an additional planned pharmacokinetic clinical trial with bafetinib in patients with brain cancer, two planned Phase 2
clinical trials for INNO-206 as a treatment for soft tissue sarcomas and pancreatic cancer following an abbreviated safety trial, and clinical trials with
tamibarotene for the treatment of non-small-cell lung cancer and acute promyelocytic leukemia, or APL. In addition to our core oncology programs, we own
rights to two drug candidates based on our molecular chaperone regulation technology, which are designed to repair or degrade mis-folded proteins associated
with disease. Our current business strategy is to seek one or more strategic partnerships to pursue the development of this technology or an outright sale of the
assets.
In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds received upon the exercise
of options and warrants, and sales of our shares of RXi common stock. We also have received limited payments from our strategic partners and licensees.
28
At December 31, 2010, we had cash and cash equivalents of approximately $6.3 million, marketable securities of $20.6 million and proceeds from sale
of the balance of RXi shares of $6.9 million. Management believes that our current cash on hand, together with our marketable securities and proceeds from
sale of RXi shares will be sufficient to fund our operations for the foreseeable future. The estimate is based, in part, upon our currently projected expenditures
for 2011 of approximately $20.1 million (unaudited), which includes approximately $3.5 million (unaudited) for our clinical programs for INNO-206,
approximately $2.2 million (unaudited) for our clinical programs for bafetinib, approximately $5.5 million (unaudited) for our clinical program for
tamibarotene, approximately $2.0 million (unaudited) for general operation of our clinical programs, and approximately $6.8 million (unaudited) 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 will be required to obtain additional funding in order to execute our 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 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 after 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. In 2009, the investment balance in RXi was
reduced to zero, and we stopped recording our share of losses from RXi. On June 30, 2010, we sold 2.0 million common shares of RXi and our ownership in
RXi was reduced to approximately 3.1 million shares of common stock, approximately 17% of the outstanding shares of RXi. We thereafter began to account
for those shares as available for sale, and increases or decreases were included as part of comprehensive income or loss. This investment was shown on the
balance sheet at market value, based on RXi’s closing stock price as reported on The Nasdaq Capital Market.
We sold our remaining shares of RXi common stock in December 2010.
Research and Development
Expenditures for research and development activities related to continuing operations were $8.5 million, $7.5 million, and $10.5 million for the years
ended December 31, 2010, 2009 and 2008, or approximately 50%, 44% and 35%, respectively, of our total expenses.
Research and development expenses are further discussed below under “Critical Accounting Policies and Estimates” and “Results of Operations.”
Our currently projected expenditures for 2011 include approximately $3.5 million for our clinical programs for INNO-206, approximately $2.2 million
for our clinical programs for bafetinib, approximately $5.5 million for our clinical program for tamibarotene, and approximately $2.0 million for general
operation of our clinical programs. 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.
29
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 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
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 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 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.
30
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 marketable securities, which we subsequently sold for approximately $24.3 million, 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. We accounted for the transaction under ASC 730-20 (previously
Statement of Financial Accounting Standards No. 68, Research and Development Arrangements). Accordingly, we recorded the value received under the
arrangement as deferred service revenue and recognize service revenue, using the proportional performance method of revenue recognition, on a dollar-for-
dollar basis for each dollar of expense incurred for the research and development of arimoclomol and other potential ALS treatments. In August 2009, we
were released from all restrictions on the use of any proceeds previously paid to us in connection with the arrangement. As a result, we recognized in the third
quarter $6.7 million of service revenue representing the remaining deferred revenue and previously un-recognized portion of the value received in the
transaction with ALSCRT. For the years ended December 31, 2009 and 2008, we recognized approximately $9.4 million and $6.2 million, respectively, of
service revenue related to this transaction. No service revenue related to the ALSCRT transaction was recognized in 2010.
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 the Company’s contracts with
various clinical research organizations in connection with conducting clinical trials for its 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 stock-based employee compensation plans are described in Note 15 of the Notes to our Financial Statements. We have adopted the provisions of
ASC 718 (previously SFAS No. 123(R), Share-Based Payment (“SFAS 123(R)”)), which requires the measurement and recognition of compensation expense
for all stock-based awards made to employees and non-employees.
For stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance
with the requirements of ASC 718 (previously SFAS No. 123(R)), ASC 505-50 (previously 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 ASC 505
(previously 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 or warrants are fully
vested.
31
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. The remaining fixed assets from our San Diego
laboratory have been re-allocated from Equipment and Furnishings to Assets Held for Sale and were sold as of September 30, 2010.
Net Income (Loss) Per Share
Basic net income (loss) per common share is computed using the weighted-average number of common shares outstanding. Diluted net income (loss) per
common share is computed using the weighted-average number of common share and common share equivalents outstanding. Common share equivalents
that could potentially dilute basic earnings per share in the future, and that were excluded from the computation of diluted loss per share, totaled
approximately 15.4 million shares, 24.4 million shares and 15.2 million shares at December 31, 2010, 2009 and 2008, respectively.
As a result of our March 11, 2008 distribution by our stockholders of approximately 36% of the outstanding shares of RXi, we recorded a deemed
dividend of approximately $757,000. The deemed dividend was 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.
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 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)
2010
Total revenues
Net income (loss)
Net income (loss) applicable to common stockholders
$
Basic and diluted loss per share applicable to common stock $
2009
Total revenues
Net income (loss)
Net income (loss) applicable to common stockholders
$
Basic and diluted loss per share applicable to common stock $
$
$
• $
• $
(611) 1,294
(611) $ 1,294 $
0.01 $
(0.01) $
1,483 $ 1,000 $
(3,973) (2,226)
(3,973) $ (2,226) $
(0.04) $ (0.02) $
• $
(4,414)
(4,414) $
(0.04) $
6,954 $
3,863
3,863 $
0.04 $
100
4,140
4,140
0.04
100
(2,983)
(2,983)
(0.03)
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 2010 and 2009, we incurred $1.6 million and $2.3 million, respectively, in employee non-cash compensation
expenses.
32
Liquidity and Capital Resources
General
In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds received upon the exercise
of options and warrants, and sales of our shares of RXi common stock. We also have received limited payments from our strategic partners and licensees.
At December 31, 2010, we had cash and cash equivalents of approximately $6.3 million, marketable securities of $20.6 million and proceeds from sale
of the balance of RXi shares of $6.9 million. Management believes that our current cash on hand, together with our marketable securities and proceeds from
sale of RXI shares will be sufficient to fund our operations for the foreseeable future. The estimate is based, in part, upon our currently projected expenditures
for 2011 of approximately $20.1 million, which includes approximately $3.5 million for our clinical programs for INNO-206, approximately $2.2 million for
our clinical programs for bafetinib, approximately $5.5 million for our clinical program for tamibarotene, approximately $2.0 million for general operation of
our clinical programs, and approximately $6.8 million for other general and administrative expenses. These projected expenditures are also based upon
numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections. We will be
required to obtain additional funding in order to execute our 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.
If we obtain marketing approval as currently planned and successfully commercialize our product candidates, we anticipate it will take a minimum of
several 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 continuing poor economy. Despite
the recovery in the U.S. financial markets in 2009, the market remains severely depressed for private investment in public equities, or PIPEs, transactions on
which we have relied for raising needed capital. 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.
Discussion of Operating, Investing and Financing Activities
Net profit for the year ended December 31, 2010 was $0.4 million, and cash used for operating activities for that period was $14.6 million. The net profit
for the year reflects a gain of $15.8 million from the sale of RXi shares, $1.6 million of stock option and warrant expense and $0.9 million fair value
adjustment of the warrant liability.
Net loss for the year ended December 31, 2009 was $4.8 million, and cash used for operating activities for that period was $12.1 million. The net loss for
the year reflects $9.4 million of revenue recognized under the 2006 agreement with ALSCRT, $2.9 million of stock option and warrant expense and $0.7
million fair value adjustment of the warrant liability.
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 revenue recognized under the 2006 agreement with ALSCRT, a expense of $8.0 million related to the acquisition of
Innovive’s in-process research and development, a loss of $3.9 million in our equity in RXi, and $2.1 million of stock option and warrant expense.
For the year ended December 31, 2010, $10.8 million was provided by investing activities. This included $8.9 million received from the sale of RXi
common shares and $2.2 million net from the proceeds of sales of marketable securities, partially offset by $0.3 million used to purchase equipment and
furnishings.
33
For the year ended December 31, 2009, $21.6 million was used in investing activities. This included $22.8 million used to purchase marketable
securities, which was partially offset by proceeds of $1.2 million from the sale of 500,000 of our shares of common stock RXi.
For the year ended December 31, 2008, $7.0 million was used in investing activities including $10.0 million of RXi funds resulting from converting
marketable securities to cash equivalents that 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.
Cash provided by financing activities for the year ended December 31, 2010 was $0.2 million, which was attributable to the exercise of previously
outstanding stock options and warrants.
Cash provided by financing activities for the year ended December 31, 2009 was $18.6 million. During 2009, we raised $18.3 million in a private
placement of our common stock and an additional $0.3 million from the exercise of previously outstanding stock options and warrants.
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.
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 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 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.
Our current contractual obligations that will require future cash payments are as follows (in thousands):
2011
2012
2013
2014
2015 and thereafter
Total
____________
Operating
Leases (1)(2)
Employment
Agreements (3)
Subtotal
Research and
Development (4)
$
$
547 $
471
332
386
55
1,791 $
2,455 $
•
•
•
•
2,455 $
3,002 $
471
332
386
55
4,246 $
8,667 $
3,240
•
•
•
11,907 $
Total
11,669
3,711
332
386
55
16,153
(1) Operating leases are primarily facility lease related obligations, as well as equipment and software lease obligations with third party vendors.
34
(2) The Company is entitled to receive future rental income under subleases in place which would be offset against future operating lease obligations as
follows: $350,000 in 2011 and $235,000 in 2012.
(3) 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.
(4) Research and development obligations relate primarily to clinical trials. Most of these purchase obligations are cancelable.
We apply the disclosure provisions of ASC 460 (formerly FASB Interpretation No. (“FIN”) 45, Guarantor’s Accounting and Disclosure Requirements
for Guarantees, Including Indirect Guarantees of Indebtedness of Other), to our contractual guarantees and Indemnities. We have provided contractual
indemnities to investors and other parties against possible losses suffered or incurred by the indemnified parties in connection with various types of third-party
claims, as well as indemnities to our officers and directors against third party claims arising from the services they provide to us. To date, we have not
incurred material costs as a result of these indemnities, and we do not expect to incur material costs in the future; further, we maintain insurance to cover
certain losses arising from these indemnities. Accordingly, we have not accrued any liabilities in our consolidated financial statements related to these
indemnities.
Net Operating Loss Carryforwards
At December 31, 2010, we had United States federal and state net operating loss carryforwards of $100.3 million and $79.4 million, respectively,
available to offset against future taxable income, which expire in 2011 through 2030. Approximately $13.7 million of our federal net operating loss
carryforwards are limited in their availability to $363,000 annually. Management currently believes that the remaining $86.6 million in federal net operating
loss carryforwards, and the $65.7 million in state net operating loss carryforwards as of December 31, 2010, 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.
As of December 31, 2010, we also had research and development and alternative minimum tax credits for federal and state purposes of approximately $4.8
million and $5.2 million, respectively, available for offset against future income taxes, which expire in 2022 through 2030. 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 its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology
companies, we have concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a
100% deferred tax valuation allowance has been recorded against these assets.
Results of Operations
We incurred a net profit (loss) of $0.4 million, ($4.8 million) and ($27.8 million) for the years ended December 31, 2010, 2009 and 2008, respectively.
During 2010, we recognized no service revenues. During fiscal 2009, we recognized $9.4 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. Pursuant to an amendment signed between us and the
beneficiary of the ALSCRT on August 6, 2009, we were released from all restrictions on the use of any proceeds previously paid to us in connection with the
arrangement. As a result, we recognized $6.7 million as service revenue in the third quarter of 2009, which represented the remaining deferred revenue and
previously un-recognized portion of the value received. In the year ended December 31, 2008, we recognized $6.2 million in service revenues.
During 2010, 2009 and 2008, 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 2010, we are not anticipating the receipt of
any significant service or licensing fees.
Our net loss 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.
35
Research and Development
Research and development expenses
Non-cash research and development expenses
Impairment loss on fixed assets
Employee stock option expense
Years Ended December 31,
2010 2009 2008
(In thousands)
$ 8,207 $ 5,621 $ 9,913
(224)
•
777
$ 8,507 $ 7,542 $ 10,466
62
• 1,187
672
208
92
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 2010, 2009 and 2008 relate to our various development programs. In 2010, we initiated two Phase 2
clinical trials with bafetinib and one with tamibarotene, and made preparations to initiate several additional clinical trials with INNO-206, which resulted in an
increase in research and development expenses over 2009. Research and development expenses in 2009 decreased as compared to 2008, as we substantially
completed the initial phase of our new-drug discovery research in our laboratory facility in San Diego, California. In 2010, our development costs associated
included approximately $2.0 million for our clinical programs for INNO-206, approximately $2.7 million for our clinical programs for bafetinib, $1.4 million
for our clinical program for tamibarotene, and approximately $2.1 million for general operation of our clinical programs. None of our research and
development costs have ever been capitalized.
As compensation to consultants, and in connection with the acquisition of technology, we 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 charges
(recovery) of $0.1 million, $0.1 million and $(0.2 million) in this regard during 2010, 2009 and 2008, respectively. In 2010, we recorded $0.2 million of
employee stock option expense, as compared to $0.7 million in 2009 and $0.8 million in 2008.
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 2011, we expect our research and development expenses to increase as a result of our clinical programs with INNO-206, bafetinib and tamibarotene.
General and administrative expenses
General and administrative expenses
Stock, stock option and warrant expenses to non-employees and consultants
Employee stock option expense
Year Ended December 31,
2010 2009 2008
(In thousands)
$ 6,831 $ 7,128 $ 9,134
189
1,610
$ 8,236 $ 9,128 $ 10,933
614
421
791 1,579
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 $6.8 million in 2010, $7.1 million in 2009 and $9.1 million in 2008. In 2008, we recognized RXi-related expenses for January and
February only of $1.3 million. No RXi-related expenses were recognized in 2009 or 2010. In 2009, we incurred recruiting fees and additional payroll costs
for a Business Development Officer who left in the first quarter of 2010. This additional 2009 expense of $0.2 million along with additional 2009
professional fees account for the reduction in 2010.
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. We recorded employee stock option
expense of $0.8 million in 2010, $1.6 million in 2009 and $1.6 million in 2008.
36
Depreciation and amortization
Depreciation and amortization expenses for the years ended December 31, 2010, 2009 and 2008 were $108,000, $475,000, and $625,000, respectively.
The depreciation expense reflects the depreciation of our fixed assets and the amortization expenses related to our molecular library. In 2009, the higher
depreciation included depreciation of our laboratory equipment which was disposed of during that year due to the closure of our San Diego facility.
Other Income
In 2010 and 2009, we recognized gains of $0.9 million and $0.7 million, respectively, on the valuation of our warrant derivative liability related to
warrants issued in July 2009. In 2010 and 2009, we recognized gains of $15.8 and $1.2 million, respectively, on the sale of RXi shares. In March 2008, we
recognized a gain of $0.2 million on the transfer of some RXi common stock to certain employees.
Interest income
Interest income was $0.3 million in 2010, $0.3 million in 2009 and $1.2 million in 2008. 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.
Noncontrolling Interest in RXi
We offset $88,000 of losses in noncontrolling interest in RXi against our net loss for the months of January and February 2008. For the remainder of the
year and thereafter, 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. The investment balance in RXi was eventually reduced to zero and we stopped recording our share of
losses from RXi. As a consequence of our subsequent sales of common stock of RXi, we began to account for those shares as available for sale, and any
increases or decreases were included as part of comprehensive income or loss and shown on the balance sheet at market value, based on RXi’s closing stock
price as reported on The Nasdaq Stock Market. We sold all of our remaining shares of RXi in December 2010.
Recent Accounting Pronouncements
In May 2009 and February 2010, the FASB issued new guidance for accounting for subsequent events. The new guidance, which is now part of ASC
855-10, Subsequent Events (formerly, SFAS No. 165, Subsequent Events) is consistent with existing auditing standards in defining subsequent events as
events or transactions that occur after the balance sheet date but before the financial statements are issued or are available to be issued. The new guidance
defines two types of subsequent events: “recognized subsequent events” and “non-recognized subsequent events.” Recognized subsequent events provide
additional evidence about conditions that existed at the balance sheet date and must be reflected in the company’s financial statements. Non-recognized
subsequent events provide evidence about conditions that arose after the balance sheet date and are not reflected in the financial statements of a company.
Certain non-recognized subsequent events may require disclosure to prevent the financial statements from being misleading. The new guidance was effective
on a prospective basis for interim or annual periods ending after June 15, 2009. We adopted the provisions of ASC 855-10 as required.
In June 2009, the FASB amended ASC 860, (formerly SFAS No. 166, Accounting for Transfers of Financial Assets, an amendment to SFAS No. 140).
ASC 860 eliminates the concept of a “qualifying special-purpose entity,” changes the requirements for derecognizing financial assets, and requires additional
disclosures in order to enhance information reported to users of financial statements by providing greater transparency about transfers of financial assets,
including securitization transactions, and an entity’s continuing involvement in and exposure to the risks related to transferred financial assets. ASC 860 is
effective for fiscal years beginning after November 15, 2009. The adoption of ASC 860 had no impact on our financial statements.
37
In June 2009, the FASB amended ASC 810 (formerly SFAS No.167, Amendments to FASB Interpretation No. 46). The amendments include: (1) the
elimination of the exemption for qualifying special purpose entities, (2) a new approach for determining who should consolidate a variable-interest entity, and
(3) changes to when it is necessary to reassess who should consolidate a variable-interest entity. ASC 810 is effective for the first annual reporting period
beginning after November 15, 2009 and for interim periods within that first annual reporting period. The adoption of ASC 810 did not have a material impact
on our financial statements.
In June 2009, the FASB issued new guidance which is now part of ASC 105-10 (formerly Statement of Financial Accounting Standards No. 168, The
FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles ). ASC 105-10 replaces FASB Statement No. 162,
“The Hierarchy of Generally Accepted Accounting Principles”, and establishes the FASB Accounting Standards Codification as the source of authoritative
accounting principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in conformity with
generally accepted accounting principles. ASC 105-10 is effective for interim and annual periods ending after September 15, 2009. The adoption of ASC
105-10 did not have a material impact on our financial statements.
In January, 2010, the FASB issued ASU 2010-06, Improving Disclosures about Fair Value Measurements. The standard amends ASC Topic 820, Fair
Value Measurements and Disclosures, to require additional disclosures related to transfers in and out of Levels 1 and 2 and for activity in Level 3 and clarifies
other existing disclosures requirements. We adopted ASU 2010-06 beginning January 1, 2010. This update had no impact on our financial statements.
In April 2010, the FASB issued Accounting Standard Update (“ASU”) No. 2010-17, Milestone Method of Revenue Recognition, which provides
guidance on applying the milestone method to milestone payments for achieving specified performance measures when those payments are related to
uncertain future events. However, the FASB clarified that, even if the requirements in this ASU are met, entities would not be precluded from making an
accounting policy election to apply another appropriate accounting policy that results in the deferral of some portion of the arrangement consideration. The
ASU is effective for periods beginning on or after June 15, 2010. Entities can apply this guidance retrospectively as well as prospectively to milestones
achieved after adoption. This update had no impact on our financial statements.
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 marketable securities, we believe that we are not
exposed to any material market risk. 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, 2010, 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, 2010 and 2009, and for each of the three years in
the period ended December 31, 2010, together with the reports thereon of our independent registered public accounting firms, are set forth on pages F-1 to F-
24 of this Annual Report.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
Item 9A. CONTROLS AND PROCEDURES
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
Our management, with the participation of our principal chief executive officer and principal 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
December 31, 2010, the end of the period covered by this Annual Report. Based on this evaluation, our principal chief executive officer and principal chief
financial officer have concluded that our disclosure controls and procedures were effective as of December 31, 2010.
38
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2010 that materially affected,
or are 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, as such term is defined in Exchange
Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial
officer, we assessed the effectiveness of our internal control over financial reporting as of December 31, 2010. 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 our internal control over
financial reporting was effective as of December 31, 2010.
Our internal control over financial reporting as of December 31, 2010 has been audited by BDO USA, LLP, an independent registered public accounting
firm, as stated in their report thereon set forth on pages F-22, which is incorporated herein by reference.
Item 9B. OTHER INFORMATION
None.
39
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth information concerning our directors and executive officers:
PART III
Name
Max Link, Ph.D.
Steven A. Kriegsman
Marvin R. Selter
Louis Ignarro, Ph.D.
Joseph Rubinfeld, Ph.D.
Richard L. Wennekamp
John Caloz
Daniel Levitt, M.D., Ph.D.
D. Scott Geyer
D. Scott Wieland
Benjamin S. Levin
David J. Haen
____________
Age
70
69
83
69
78
68
59
63
56
51
34
32
Class of
Director(1)
III
II
II
I
I
II
•
•
•
•
•
•
Position
Director, Chairman of the Board (2) (3) (4)
Director, Chief Executive Officer, President
Director, Vice Chairman of the Board (2) (3) (4)
Director
Director
Director (2) (3) (4)
Chief Financial Officer
Chief Medical Officer
Sr. Vice President-Manufacturing
Sr. Vice President-Drug Development
General Counsel, Vice President • Legal Affairs and Corporate Secretary
Vice President – Business Development
(1) Our Class II directors serve until the 2011 annual meeting of stockholders, our Class III director serves until the 2012 annual meeting of stockholders,
and our Class I directors serve until the 2013 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, our Chairman of the Board, 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 United States operations of
Sandoz, including President and Chief Executive Officer. Dr. Link also serves as a director of Alexion Pharmaceuticals, Inc., Celsion Corporation, Inc. and
Discovery Laboratories, Inc.
Dr. Link has extensive executive-level experience with a number of large pharmaceutical companies, including Sandoz Pharma, Ltd. In these positions,
he was responsible for major strategic and other business initiatives, including new drug development, acquisitions and dispositions of new drug candidates
and other technology, licensing, marketing and distribution agreements and other key contractual strategic arrangements that affect, or are likely to affect, our
company’s own business efforts. As an executive officer and board member of these other companies, he has experience with the regulatory schemes in
foreign jurisdictions and also has been exposed to different approaches to corporate governance matters, potential conflicts of interest, and similar matters,
which enables him to offer importance guidance to our Board of Directors.
Steven A. Kriegsman has been has been CytRx’s President and Chief Executive Officer and a director since July 2002. He also serves as a director of
RXi Pharmaceuticals Corporation and is Chairman of its Compensation and Transactions Committees. 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. During his career, he has
advised such companies as SuperGen Inc., Closure Medical Corporation, Novoste Corporation, Miravant Medical Technologies, and Maxim Pharmaceuticals.
In the past five years, Mr. Kriegsman has also served on the Board of Directors of Bradley Pharmaceuticals, Inc. and Hythiam, Inc. Mr. Kriegsman has a B.S.
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 is a graduate of the Stanford Law School Directors’ College.
40
Mr. Kriegsman was formerly a Certified Public Accountant with KPMG in New York City. 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 a guest speaker and lecturer at various universities including California
Institute of Technology (Caltech), Brown University, and New York University. Mr. Kriegsman has been active in various charitable organizations including
the Biotechnology Industry Organization, the California Health Institute, 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 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.
Mr. Selter has founded, operated, and grown his own successful businesses, which gives him a valuable insight into the financial constraints and
operational challenges facing companies in the development stage and as they mature. He also has many years of involvement in various governmental
agencies and charitable organizations, which affords him an important perspective on the business regulatory process and capital-raising activities. In
addition, he has significant education and work experience in accounting and financial matters that he is able to utilize as the named financial expert on our
Audit Committee.
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. Dr. Ignarro is a Nobel Laureate and an esteemed medical researcher whose experience enables him to offer importance scientific guidance to
our Board of Directors.
Joseph Rubinfeld, Ph.D. has been a director since July 2002. He co-founded SuperGen, Inc. in 1991 and has served as its Chief Executive Officer and
President and as a director since its inception until December 31, 2003. He resigned as Chairman Emeritus of SuperGen, Inc. on February 8, 2005. Dr.
Rubinfeld was also Chief Scientific Officer of SuperGen from 1991 until September 1997. Dr. Rubinfeld is also a founder of JJ Pharma. Dr. Rubinfeld was
one of the four initial founders of Amgen, Inc. in 1980 and served as a Vice President and its Chief of Operations until 1983. From 1987 until 1990, Dr.
Rubinfeld was a Senior Director at Cetus Corporation and from 1968 to 1980, Dr. Rubinfeld was employed at Bristol-Myers Company, International Division
in a variety of positions. Dr. Rubinfeld received a B.S. degree in chemistry from C.C.N.Y. and an M.A. and Ph.D. in chemistry from Columbia University.
Dr. Rubinfeld served as a senior executive of several large pharmaceutical companies before leaving to co-found and serves as Chief Executive Officer
or in other senior executive capacities with highly successful companies. Dr. Rubinfeld’s academic training and business experience enhances the breadth and
scope of our Board’s oversight of our company’s management, business, strategic relationships, and other activities, while his vision adds to the long-range
planning of our Board of Directors and management.
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 United States, Gerald R. Ford, and the Executive Director of the Ford Transition
Office. Prior thereto, he served as Staff Assistant to the President of the United States for one year, and as the Special Assistant to the Assistant Secretary of
Commerce of the U.S.
41
Mr. Wennekamp’s senior executive experience in the banking and financial services industry distinguishes him from our other directors and adds unique
capabilities and a different perspective to the deliberations of our Board of Directors. As a former chief credit officer at Bank of America and Community
Bank, he understands the credit needs, financing requirements, and operational constraints of development-stage and mature businesses.
Daniel Levitt, M.D., Ph.D. joined us in October 2009 as our Chief Medical Officer. Dr. Levitt brings more than 24 years of senior management
experience, having spearheaded numerous drug development programs to commercialization at leading biotechnology and pharmaceutical companies. Prior
to joining CytRx, Dr. Levitt served from January 2007 to February 2009 as Executive Vice President, Research and Development at Cerimon
Pharmaceuticals, Inc. Prior to that, from August 2003 to April 2006, he was Chief Medical Officer and Head of Clinical and Regulatory Affairs at Dynavax
Technologies Corporation, managing clinical trials for four programs and overseeing multi-country regulatory strategies. From August 2002 to July 2003, Dr.
Levitt was Chief Operating Officer and Head of Research and Development at Affymax, Inc., and prior to that he spent six years at Protein Design Labs, Inc.,
completing his tenure as that firm’s President and Head of Research and Development. Dr. Levitt’s past experience includes a position as Head of Drug
Development at Geron Corporation, and Head of the Cytokine Development Unit and Global Clinical Oncology at Sandoz Pharmaceuticals Ltd., and as
Director, Clinical Oncology and Immunology at Hoffmann-LaRoche, Inc. Dr. Levitt graduated Magna Cum Laude and Phi Beta Kappa with a Bachelor of
Arts degree from Brandeis University. He earned both his M.D. and his Ph.D. in Biology from the University of Chicago Pritzker School of Medicine. Dr.
Levitt has received 10 major research awards and authored or co-authored nearly 200 papers and abstracts.
John Y. Caloz joined us in October 2007 as our Chief Accounting Officer. 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 medical 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.
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.
Scott Geyer joined CytRx in November 2009 as our Senior Vice President, Manufacturing. Prior to joining CytRx, he served since May 2009, and also
from May 2007 through November 2008, as Vice President, Technical Operations at Cerimon Pharmaceuticals, Inc. He previously served from December
2008 through April 2009 as Senior Vice President, Technical Operations & Product Development at TRF Pharma, Inc., from October 2004 through April
2007 as Vice President, Technical Operation at Xencor, Inc., and from October 2003 through February 2004 as Vice President, Manufacturing and Process
Development at BioMarin Pharmaceuticals Inc. Mr. Geyer's past experience includes holding senior positions at Onyx Pharmaceuticals and Protein Design
Labs, Inc., as well as positions at Ares-Sorono Group and SmithKline Beckman, among others. Mr. Geyer has co-authored numerous publications in peer-
reviewed journals. He holds an M.S. in veterinary microbiology from Texas A&M University and a B.S. in microbiology from the University of
Southwestern Louisiana.
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.
David J. Haen joined CytRx in October 2003 as Director of Business Development and was promoted to Vice President of Business Development in
December 2007. From 1999 to 2003, Mr. Haen worked as an associate for Kriegsman Capital Group LLC, a financial advisory firm focused on emerging
companies in the life sciences field. Mr. Haen received a B.A. in Communications and Business from Loyola Marymount University.
42
Diversity
Our board of directors, acting through the Nomination and Governance Committee, is responsible for assembling for shareholder consideration a group
of director-nominees that, taken together, have the experience, qualifications, attributes, and skills appropriate for functioning effectively as a board. The
Nomination and Governance Committee periodically reviews the composition of the board of directors in light of the company’s changing requirements, its
assessment of the board of directors’ performance, and the input of shareholders and other key constituencies. The Nomination and Governance Committee
looks for certain characteristics common to all board members, including integrity, strong professional reputation and record of achievement, constructive and
collegial personal attributes, and the ability and commitment to devote sufficient time and energy to board service. In addition, the Nomination and
Governance Committee seeks to include on the board of directors a complementary mix of individuals with diverse backgrounds and skills reflecting the
broad set of challenges that the board of directors confronts. These individual qualities can include matters such as experience in the company’s industry,
technical experience (i.e., medical or research expertise), experience gained in situations comparable to the company’s, leadership experience, and relevant
geographical diversity.
Committees
Our business, property and affairs are managed by or under the direction of the board of directors. Members of the board are kept informed of our
business through discussion with the chief executive and financial officers and other officers, by reviewing materials provided to them and by participating at
meetings of the board and its committees.
Our board of directors currently has three committees. The Audit Committee, Compensation Committee, and Nomination and Governance Committee
consist of Messrs. Selter, Link, and Wennekamp. Such committees operate under a formal charter, copies of which are available on our website at
www.cytrx.com, that governs their duties and conduct.
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 persons 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 2010 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.
Board Leadership Structure
Our Board has placed the responsibilities of Chairman with an independent nonexecutive member of the Board, which we believe provides better
accountability between the Board and our management team. We believe it is beneficial to have an independent Chairman whose sole responsibility to us is
guiding our Board members as they provide leadership to our executive team. Our Chairman is responsible for communication among the directors; setting
the Board meeting agendas in consultation with the President and Chief Executive Officer; and presiding at Board meetings, executive sessions and
stockholder meetings. This delineation of duties allows the President and Chief Executive Officer to focus his attention on managing the day-to-day business
of the company. We believe this structure provides strong leadership for our Board, while positioning our President and Chief Executive Officer as the leader
of the company in the eyes of our employees and other stakeholders.
43
Board of Directors Role in Risk Oversight
In connection with its oversight responsibilities, our board of directors, including the Audit Committee, periodically assesses the significant risks that we
face. These risks include, but are not limited to, financial, technological, competitive, and operational risks. Our board of directors administers its risk
oversight responsibilities through our Chief Executive Officer and Chief Financial Officer, who review and assess the operations of our business as well as
operating management’s identification, assessment and mitigation of the material risks affecting our operations.
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. Generally speaking, the Compensation Committee has advisory authority only with respect to the compensation of our
Chief Executive Officer and other named executive officers. The final authority to make compensation decisions rests with our Board of Directors.
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.
The Compensation Committee operates under a formal charter, copies of which are available on our website at www.cytrx.com, that governs its duties
and conduct.
Throughout this Annual Report, the individuals included in the Summary Compensation Table below are referred to as our “named executive officers.”
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 the achievement of corporate goals and each individual executive’s job performance 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 strategic goals of our company. We use annual and other periodic cash
bonuses to reward an officer’s achievement of specific goals, including goals related to the development of our drug candidates and management of working
capital. We use 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.
Each of the corporate goals determined and reviewed by the Compensation Committee results from a collaboration among our named executive officers,
including the leadership of our President and Chief Executive Officer and the support of our principal legal, financial, clinical, medical and business
development officers. The Committee’s assessment of the relative contribution of each named executive officer is based on periodic reports to our full Board
of Directors regarding the progress of these business accomplishments and the individual efforts of our named executive officers, and year-end consultations
with our President and Chief Executive Officer that are a normal part of the Committee’s compensation determinations. The Committee employs no objective
measure of any individual’s contribution.
44
The bonus amounts awarded to our eligible named executive officers are a function of their office and total compensation relative to the total
compensation of our President and Chief Executive Officer, as adjusted by their relative employee evaluation, and with consideration given to comparable
company data for similarly situated employees. The bonus amounts awarded to each named executive officer is set forth in the Summary Compensation
Table.
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.
Role of Executive Officers in Compensation Decisions
The Compensation Committee annually recommends the compensation of our named executive officers to our Board of Directors, which has the final
decision-making authority. Our Board of Directors, at its discretion, may accept or reject the Committee’s recommendations or require revisions to such
recommendations.
Our President and Chief Executive Officer, or CEO, typically attends all meetings of the Compensation Committee, except for executive sessions. At
the request of the Compensation Committee, our CEO provides his assessment of the performance of our named executive officers, other than himself. Our
CEO also takes an active part in the discussions of the compensation of named executive officers other than himself and assists in the development of a
review matrix of each executive’s contributions to the goals of the company that forms the basis for some compensation determinations. The Compensation
Committee grants due consideration to our CEO’s assessments when making recommendations to our Board of Directors regarding the compensation of our
named executive officers. All Compensation Committee deliberations and determinations regarding the compensation of our CEO are made without the
presence of our CEO. All recommendations regarding our CEO’s compensation are based on the Compensation Committee’s own assessment and evaluation,
which are reviewed and acted upon by our Board of Directors.
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 2010, the Compensation Committee obtained
three industry compensation surveys and used them in its compensation deliberations regarding cash and equity compensation for our executive officers. The
surveys used were an Equilar survey of public companies with a market capitalization between $50 million and $200 million, a survey of public and private
life sciences companies of all sizes provided by Radford, and a survey of public and private companies in Los Angeles provided by salary.com (which the
Compensation Committee uses to adjust to geographic differences in cost of living).
The Compensation Committee utilized this data to set annual salary increases and bonus amounts 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 experience level related to
their position with us. The Compensation Committee has no policy regarding the use of benchmarks, and we have no established policy or target for the
allocation between cash and non-cash incentive compensation.
The Compensation Committee is authorized to retain its own independent advisors to assist in carrying out its responsibilities, but has not relied upon
outside compensation consultants.
Performance-driven Compensation
We emphasize performance in annually reviewing and setting our executive officers’ base salary, bonuses and equity incentive compensation. This
emphasis on performance with respect to a substantial portion of compensation is intended to motivate our executive officers to pursue our corporate goals,
reward them for achievement of these goals and align their interests with those of our stockholders.
45
Each year, we determine goals that we hope to achieve in the coming year, both on a corporate and individual basis. Our overall corporate performance
as compared to these goals, and an individual’s performance compared to his or her individual goals, primarily drive the recommendations that the
compensation committee makes with respect to each executive officers’ base salary, cash bonusand equity incentive compensation. Other factors, such as
larger macroeconomic conditions of the industry and market in which we compete, as well as strategic business decisions and issues related to key employee
retention, also influence compensation decisions. For example, for 2009, in response to the financial crisis in late 2008, our management and Compensation
Committee determined that no salary increase would be made in 2009.
Individual performance goals for each year initially are identified and developed by senior executives through a self-evaluation and goal-setting process,
and our CEO refines and documents those goals in conjunction with the Compensation Committee. At the end of the year, the Compensation Committee
reviews each performance goal and determines the extent to which we achieved such goals, and our CEO assesses the achievement of specific performance
goals relating to other executive officers.
In establishing performance goals, the Compensation Committee considers whether the goals could possibly result in an incentive for any executives to
take unwarranted risks in our company’s business and generally seeks to avoid creating any such incentives.
Company Performance Goals
For 2010, the Compensation Committee and the Board of Directors approved the following performance goals:
•
•
•
•
•
•
•
•
Initiate up to three clinical trials for bafetinib in patients with CLL, prostate cancer and brain cancer
Finalize INNO-206 formulation for clinical development
Initiate up to three clinical trials for INNO-206 in patients with pancreatic cancer, soft tissue sarcomas and stomach cancer
Continue development of tamibarotene for APL, and consider expansion of tamibarotene development into new indications
Review potential in-licensing and acquisition opportunities in oncology
Seek opportunities to spin out, sell or partner molecular chaperone assets
Dispose of some or all of the Company’s RXi stock to raise working capital
Continue compliance with financial and legal regulations, remain in good standing with all financial and legal regulatory agencies
For 2010, the Compensation Committee determined that each of the corporate goals had either been achieved, or substantial progress towards
achievement had been made, and noted the particular contributions of executive officers to the achievement of those goals.
Individual Performance
The Compensation Committee reviews our executive officers’ performance based on overall achievement of the corporate goals and a review of
individual goals developed for each executive officer every year. The Compensation Committee, with the assistance of our CEO, determines the relative
achievement of the performance goals applicable to each executive officer, and assigns a performance rating based on a set of criteria set forth in an
evaluation form. No specific formula is used with respect to setting any particular element of compensation based on the individual performance metrics. The
score assigned to each officer was based on a subjective assessment by our Compensation Committee members of the officer’s performance against the
scoring standards of:
1 – Consistently Exceeds Expectations
2 – Sometimes Exceeds Expectations
3 – Meets Expectations
4 – Sometimes Meets Expectations
5 – Needs Improvement
46
The numerical job scores, with a 1 being the best, and 5 being the worst, are determined based on an initial self-assessment by the officer, which is
subject to change based on an evaluation of the self-assessment by the officer’s direct supervisor and on the Compensation Committee’s own assessment of
the officer’s job performance.
For 2010, our Compensation Committee determined that the individual performance scores indicated below were merited by the officer’s respective
contributions to our key business achievements discussed above, as well as the performance of their day-to-day responsibilities. On an officer-by-officer
basis, our Compensation Committee also considered the following:
Mr. Kriegsman’s individual performance goals relate primarily to overall corporate objectives, including building stockholder value, managing working
capital, management and successful operation of the executive management team, and development of personnel for future success. Based on those criteria,
and noting our non-dilutive management of working capital through sales of RXi shares and successful completion of key strategic clinical goals, the
Compensation Committee gave a rating of 1.2 to Mr. Kriegsman.
Mr. Caloz’s individual performance goals relate primarily to achievement of key financial objectives, such as managing and raising working capital,
controlling spending, managing accounting personnel and maintaining regulatory compliance. Based on those criteria, the Compensation Committee noted
Mr. Caloz’s role in the improved performance of the accounting department, its compliance with filing deadlines, and our non-dilutive sales of RXi shares,
and gave a rating of 2.4 to Mr. Caloz.
Dr. Levitt’s individual performance goals relate primarily to the achievement of key strategic and clinical objectives related to our clinical research
programs, including ultimate oversight of the design and execution of our clinical programs, and analysis and implementation of new clinical opportunities
improve stockholder value. Based on those criteria, the Compensation Committee noted Dr. Levitt’s efforts towards our achievement of our key clinical
goals, and his development of strategic plans to build value, and gave a rating of 1.1 to Dr. Levitt.
Mr. Levin’s individual performance goals relate primarily to the management of the company’s legal risk, advice provided to the Board of Directors and
management, and maintaining regulatory compliance. Based on those criteria, the Compensation Committee noted Mr. Levin’s timely and useful advice on
key corporate matters that reduced corporate risk, and his work ensuring compliance with various regulations, and gave a rating of 1.2 to Mr. Levin.
Dr. Wieland’s individual performance goals relate primarily to the execution of the objectives related to our clinical development, including planning,
initiation, budgeting and management of our clinical programs. Based on those criteria, the Compensation Committee noted Dr. Wieland’s role in our
achievement of key clinical goals and gave a rating of 2.0 to Dr. Wieland.
2010 Executive Compensation Components
For 2010, as in recent years, the principal components of compensation for the named executive officers were:
•
•
•
base salary;
annual 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.
Generally, the base salary element of compensation is used to recognize the experience, skills, knowledge and responsibilities required of each named
executive officer, and over time reflects our executive officers’ overall sustained performance and contributions to our business.
47
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
to a lesser extent, 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. The increase in 2010 base salaries over 2009 was made in consideration of our successful achievement or substantial progress
towards the corporate performance goals for 2010, achievement of individual performance goals as they related to each executive officer and the subjective
assessment of each executive officer’s performance of major job responsibilities. Each of the base salary increases was reviewed in light of the Equilar,
Radford and salary.com survey data to validate that they were within acceptable ranges based on market salaries.
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 annual bonus awards on the
achievement of corporate and individual goals, efforts related to extraordinary transactions, effective fund-raising efforts, effective management of personnel
and capital resources, and bonuses paid by comparable companies, among other criteria. Mr. Kriegsman’s employment agreement entitles him to an annual
cash bonus in an amount to be determined in our discretion, but not less than $150,000, and Dr. Levitt’s employment agreement provides that his bonus will
not be less than 25% of his base salary. Any cash bonuses to our other named executive officers are entirely in our discretion.
During 2010, the Compensation Committee granted Mr. Kriegsman an annual cash bonus of $450,000, and granted cash bonuses to the other named
executive officers ranging from $25,000 to $135,000, principally based on their efforts in helping us advance the development of our products and raise
capital.
Equity Incentive Compensation
We believe that strong long-term corporate performance is achieved with a corporate culture that encourages a long-term focus by our executive officers
through the use of equity awards, the value of which depends on our stock performance. We have established equity incentive plans to provide all of our
employees, including our executive officers, with incentives to help align those employees’ interests with the interests of our stockholders and to enable them
to participate in the long-term appreciation of our stockholder value. Additionally, equity awards provide an important retention tool for key employees, as the
awards generally are subject to vesting over an extended period of time based on continued service with us.
Typically, equity awards are granted annually at the end of each year based primarily on corporate performance as a whole during the preceding year. In
addition, we may grant equity awards upon the occurrence of certain events during the year, for example, upon an employee’s hire or achievement of a
significant business objective.
No formula is used in setting equity award grants and the determination of whether to grant equity awards, as well as the size of such equity awards, to
our executive officers; rather, it involves subjective assessments by our Board of Directors, Compensation Committee and, with respect to executive officers
other than himself, our CEO. Generally, annual equity awards are driven by our retention of experienced employees, and we consider individual performance
and contributions during the preceding year to the extent our Board of Directors and Compensation Committee believe such factors are relevant. As with base
salary and cash bonuses, for 2010 our Board of Directors and compensation Committee also considered data from three surveys in determining equity award
grants to our executive officers.
48
In 2010, the Compensation Committee granted to Mr. Kriegsman nonqualified options to purchase 750,000 shares of our common stock at a price of
$1.01 per share, which equaled the closing market price on the date of grant. The option vests monthly over three years, unless Mr. Kriegsman’s employment
is terminated by us without “cause,” or by Mr. Kriegsman for “good reason,” in which case they vest immediately. 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.
Generally speaking, we have not taken into consideration any amounts realized by our named executive officers from prior stock option or stock awards
in determining whether to grant new stock options or stock awards. No named executive officers have exercised options since 2003.
Retirement Plans, Perquisites and Other Personal Benefits
Our executive officers are eligible to participate in the same group insurance and employee benefit plans as our other salaried employees. These benefits
include medical, dental, vision, and disability benefits and life insurance.
We have adopted a tax-qualified employee savings and retirement plan, our 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 2010. Matching contributions, if any, are subject to a vesting schedule; all employee 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 2010 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, 2010 and under which Mr. Kriegsman’s designee is the beneficiary. We
periodically review the levels of perquisites and other personal benefits provided to our named executive officers, but no changes to these benefits were made
during 2010, and we do not expect any such changes in the foreseeable future.
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.
49
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 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
helps us to maintain 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 generally (except in the case of Mr. Kriegsman) 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 from 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.
50
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. 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. We have not established any
policy regarding recoupment, or “clawback,” of any performance-based compensation in the event our company’s historical performance is subsequently
revised or restated in a way that would have produced a lower compensation amount. We also have not relied upon wealth accumulation analyses, or “tally
sheets,” or internal pay equity analyses in making executive compensation decisions.
These policies remained in place throughout 2010, and we expect to continue to follow them for the foreseeable future.
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. Max Link, Ph.D., Marvin R. Selter and
Richard L. Wennekamp all served as members of the Compensation Committee during 2010.
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
51
Summary Compensation Table
The following table presents summary information concerning all compensation paid or accrued by us for services rendered in all capacities during 2010,
2009 and 2008 by Steven A. Kriegsman and John Y. Caloz, who are the only individuals who served as our principal executive and financial officers during
the year ended December 31, 2010, and our three other most highly compensated executive officers who were serving as executive officers as of December
31, 2010:
Name and Principal Position
Steven A. Kriegsman
President and Chief Executive Officer
John Y. Caloz
Chief Financial Officer and Treasurer
Daniel Levitt, M.D., M.D., Ph.D.
Chief Medical Officer
Benjamin S. Levin General Counsel,
General Counsel, Vice President • Legal
Affairs and Secretary
Scott Wieland, Ph.D.
Senior Vice President – Drug Development
____________
Summary Compensation Table
Year Salary ($)
Bonus
($)(1)
Option
Awards
($) (2)
All Other
Compensation ($)(3)
Total
($)
2010
2009
2008
2010
2009
2010
2009
2010
2009
2008
2010
2009
2008
650,000
550,000
551,000
450,000
450,000
150,000
564,750
906,000
517,800
325,000
275,000
25,000
80,000
37,650
137,750
375,000
83,894
135,000
•
188,250
405,000
315,000
276,000
276,000
315,000
275,000
255,500
85,000
75,000
55,000
75,300
119,100
125,300
75,000
75,000
73,250
75,300
105,750
43,730
10,000
10,000
10,000
1,674,750
1,916,000
1,228,800
•
•
•
•
•
•
•
•
•
•
387,650
492,750
698,250
488,894
475,300
470,100
456,300
465,300
455,750
372,480
(1) Bonuses to the named executive officers reported above were paid in December of the applicable year.
(2) The values shown in this column represent the aggregate grant date fair value of equity-based awards granted during the fiscal year, in accordance with
ASC 718, “Share Based-Payment”. At the 2009 Annual Meeting of Stockholders held on July 1, 2009, the Company’s stockholders approved an
amendment to the Company’s 2000 Long-Term Incentive Plan to allow for a one-time stock option re-pricing program for employees and
officers. Pursuant to the re-pricing program, 3,265,500 eligible stock options held by ten eligible employees and officers were amended to reduce the
exercise prices of the options to $1.15 per share, which was the closing sale price of CytRx’s common stock as reported on The NASDAQ Capital
Market on the July 1, 2009 completion date of the re-pricing program, and to impose a new option vesting schedule. The values in this column include
the incremental increase in the fair value of the re-priced options over the fair value of the original award. The fair value of the stock options at the date
of grant was estimated using the Black-Scholes option-pricing model, based on the assumptions described in Note 15 of the Notes to Financial
Statements included in this Annual Report.
(3) This amount represents life insurance premiums.
52
2010 Grants of Plan-Based Awards
In 2010, we granted stock options to our named executive officers under our 2008 Stock Incentive Plan as follows:
2010 Grants of Plan-Based Awards
Name
Steven A. Kriegsman
President and Chief Executive Officer
John Y. Caloz
Chief Financial Officer and Treasurer
Daniel Levitt, M.D., Ph.D.
Chief Medical Officer
Benjamin S. Levin
General Counsel, Vice President • Legal Affairs and Secretary
Scott Wieland, Ph.D.
Senior Vice President – Drug Development
____________
2000 Long-Term Incentive Plan and 2008 Stock Incentive Plan
All Other
Option Awards
(# of CytRx
Shares)
Exercise Price of
Option Awards
($/Share)
Grant Date
Fair Value of
Option Awards
($)
750,000 $
1.01 $
564,750
Grant Date
12/14/2010
12/14/2010
50,000 $
1.01 $
37,650
12/14/2010
250,000 $
1.01 $
188,250
12/14/2010
100,000 $
1.01 $
75,300
12/14/2010
100,000 $
1.01 $
75,300
The purpose of our 2000 Long-Term Incentive Plan, or 2000 Plan, and our 2008 Stock Incentive Plan, or 2008 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. The 2000 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. On May 11, 2009, our Board of Directors approved an amendment to the 2000 Plan to
allow for a one-time stock option re-pricing program for our employees. The 2008 Plan was adopted by our Board of Directors on November 21, 2008 and by
our stockholders on July 1, 2009.
2000 Plan and 2008 Plan Descriptions
The 2000 Plan and the 2008 Plan, or the Plans, are 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 Plans.
53
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 under the 2000 Plan 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 under the 2000 Plan 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 under the 2000 Plan 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
2000 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.
Performance Goals. The Compensation Committee in its discretion may determine awards under the 2000 Plan 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.
54
Limitations on Transfer; Beneficiaries. Awards under the Plans may not be transferred or assigned by 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 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 Plans, 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 Plans 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
Plans 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.
55
Holdings of Previously Awarded Equity
Equity awards held as of December 31, 2010 by each of our named executive officers were issued under our 2000 Plan and 2008 Plan. The following
table sets forth outstanding equity awards held by our named executive officers as of December 31, 2010:
2010 Outstanding Equity Awards at Fiscal Year-End
Number of Securities Underlying
Unexercised Options (#)
Option Awards
President and Chief Executive Officer
Name Exercisable
•
Steven A. Kriegsman
250,140
208,360
324,945
350,000
200,000
300,000
250,000
750,000
Unexercisable Option Exercise Price (3) ($) Option Expiration Date
12/14/20
12/10/19
11/21/18
4/07/18
4/18/17
6/16/16
5/17/15
6/19/13
6/20/13
750,000
499,860
91,640
125,055
•
•
•
•
•
1.01
1.05
0.37
1.15
1.15
1.15
0.79
1.15
1.15
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(2)
(2)
John Y. Caloz
Chief Financial Officer and Treasurer
Daniel Levitt, M.D., Ph.D.
Chief Medical Officer
Benjamin S. Levin
General Counsel, Vice President • Legal
Affairs and Secretary
Scott Wieland, Ph.D.
Senior Vice President – Drug Development
____________
•
41,690
31,950
33,335
16,665
16,665
49,995
(1)
(1)
(1)
(2)
(2)
(2)
(2)
•
194,530
(1)
(1)
•
33,350
69,450
83,330
100,000
90,000
150,000
160,000
•
33,350
16,665
19,800
16,665
75,000
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(2)
(1)
(1)
(2)
(2)
(2)
(2)
50,000
83,310
18,050
16,665
8,335
8,335
25,005
250,000
305,470
100,000
66,650
30,650
16,670
•
•
•
•
100,000
66,650
8,335
10,200
8,335
•
1.01
1.05
0.30
0.37
1.15
1.15
1.15
1.01
1.06
1.01
1.05
0.37
1.15
1.15
1.15
0.79
1.15
1.01
1.05
1.15
0.57
1.15
1.15
12/14/20
12/10/19
01/02/19
11/21/18
04/07/18
12/06/17
10/26/17
12/14/20
11/21/18
12/14/20
12/10/19
11/21/18
4/07/18
4/18/17
6/16/16
5/17/15
7/15/14
12/14/20
12/10/19
11/21/18
07/01/18
12/06/17
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) The reported options with prices of $1.15 were re-priced to that exercise price on July 1, 2009 at $1.15.
56
Option Exercises and Stock Vested
There were no exercises of stock options by any of our named executive officers during 2010.
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 2009 to
continue through December 31, 2012. The employment agreement will automatically renew in December 2012 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 $700,000. 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 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.
57
Employment Agreement with Daniel Levitt, M.D., Ph.D.
Daniel Levitt is employed as our Chief Medical Officer pursuant to an employment agreement dated as of January 1, 2011 that expires on December 31,
2011. Dr. Levitt is entitled under his employment agreement to receive an annual base salary of $450,000 and is eligible to receive an annual bonus as
determined by our board of directors (or our Compensation Committee) in its sole discretion, but not to be less than 25% of his 2011 base salary. In the event
we terminate Dr. Levitt’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 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, 2011 that expires
on December 31, 2011. Mr. Caloz is entitled under his employment agreement to receive an annual base salary of $335,000 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 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, 2011 that
expires on December 31, 2011. Dr. Wieland is paid an annual base salary of $330,000 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, 2011 that expires on December 31, 2011. Mr. Levin is paid an annual base salary of $340,000 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.
Employment Agreement with Scott Geyer
Scott Geyer is employed as our Senior Vice President • Manufacturing pursuant to an employment agreement dated as of January 1, 2011 that expires on
December 31, 2011. Mr. Geyer is paid an annual base salary of $300,000 and is eligible to receive an annual bonus as determined by our board of directors (or
our Compensation Committee) in its sole discretion. In the event we terminate Mr. Geyer’s employment without “cause” (as defined), we have agreed to pay
him a lump-sum equal to his accrued but unpaid salary and vacation, plus an amount equal to six months’ base salary.
58
Quantification of Termination Payments and Benefits
The table below reflects the amount of compensation to each of our named executive officers in the event of termination of such executive’s employment
without “cause” or his resignation for “good reason,” termination following a change in control and termination upon the executive’s death of permanent
disability. The named executive officers are not entitled to any payments other than accrued compensation and benefits in the event of their voluntary
resignation. The amounts shown in the table below assume that such termination was effective as of December 31, 2010, and thus includes amounts earned
through such time, and are estimates only of the amounts that would be payable to the executives. The actual amounts to be paid will be determined upon the
occurrence of the events indicated.
Termination Payments and Benefits
Name
Steven A. Kriegsman
President and Chief
Executive Officer
John Y. Caloz
Chief Financial Officer
Daniel Levitt, M.D., Ph.D.
Chief Medical Officer
Benjamin S. Levin
General Counsel, Vice
President • Legal
Affairs and Secretary
Scott Wieland, Ph.D.
Senior Vice President –
Drug Development
____________
Benefit
Severance Payment(4)
Stock Options (1)
Health Insurance (2)
Life Insurance
Bonus
Tax Gross Up (3)
Severance Payment(4)
Stock Options (1)
Severance Payment(4)
Severance Payment
Stock Options (1)
Severance Payment(4)
Stock Options (1)
Termination w/o Cause or
for Good Reason
Before Change in
Control ($)
After Change in
Control ($)
1,400,000
•
97,930
10,000
300,000
•
167,500
•
225,000
170,000
•
165,000
•
1,400,000 1,400,000
•
•
•
300,000
•
•
•
•
Death ($) Disability ($)
1,400,000
•
97,930
10,000
300,000
•
•
•
•
•
97,930
10,000
300,000
0
167,500
•
225,000
Change in
Control ($)
•
58,650
97,930
•
•
•
•
23,482
•
170,000
•
165,000
•
•
•
•
•
•
•
•
•
•
19,616
•
4,488
(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, 2010, determined by the aggregate difference between the stock price as of December 31, 2010 and the exercise prices of
the underlying options.
(2) Represents the cost as of December 31, 2010 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.
59
Compensation of Directors
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 2009. 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 $2,500 for each meeting attended of
the audit committee. In July 2009, we granted stock options to purchase 50,000 shares of our common stock at an exercise price equal to the current market
value of our common stock to each non-employee director. The options were vested, in full, upon grant.
The following table sets forth the compensation paid to our directors other than our Chief Executive Officer for 2010:
Director Compensation Table
Name (1)
Max Link, Ph.D.
Chairman
Marvin R. Selter
Vice Chairman
Louis Ignarro, Ph.D.
Director
Joseph Rubinfeld, Ph.D.
Director
Richard L. Wennekamp
Director
Fees Earned or
Paid in Cash
($) (2)
Option
Awards
($) (3)
120,250
35,000
Total ($)
155,250
108,250
35,000
143,250
41,250
35,000
76,250
65,250
35,000
100,250
101,250
35,000
136,250
____________
(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 2010, we granted stock options to purchase 50,000 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 $35,000 calculated in accordance with FASB ASC Topic 718,
excluding the effect 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 14 of the Notes to
Consolidated Financial Statements.
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-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 36 equal monthly installments,
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.
60
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 10, 2011 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 10, 2011 (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 108,908,105 shares of our common stock outstanding as of March 10, 2011,
excluding treasury shares. 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%.
Common Stock
Name of Beneficial Owner Number Percent
*
Louis Ignarro, Ph.D.(1)
6.2%
Steven A. Kriegsman(2)
*
Max Link, Ph.D.(3)
*
Joseph Rubinfeld, Ph.D.(4)
*
Marvin R. Selter(5)
*
Richard L. Wennekamp(6)
*
Dan Levitt, M.D., Ph.D.(7)
*
John Y. Caloz (8)
*
Scott Wieland, Ph.D.(9)
*
Benjamin S. Levin(10)
All executive officers and directors as a group (eleven persons)(11)
9.1%
____________
668,916
6,916,917
289,519
227,000
572,451
220,000
277,778
223,615
232,508
722,240
10,427,339
Shares of
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Includes 577,000 shares subject to options or warrants.
Includes 2,895,817 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.
Includes 234,543 shares subject to options or warrants.
Includes 227,000 shares subject to options or warrants.
The shares shown are owned, of record, by the Selter Family Trust or Selter IRA Rollover. Includes 215,000 shares subject to options or warrants
owned by Mr. Selter.
Includes 215,000 shares subject to options or warrants.
Includes 277,778 shares subject to options or warrants.
Includes 223,615 shares subject to options or warrants.
Includes 232,508 shares subject to options or warrants.
(10)
Includes 722,240 shares subject to options or warrants.
(11)
Includes 5,896,896 shares subject to options or warrants.
61
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.
62
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 USA, LLP, or BDO, serves as our independent registered public accounting firm and audited our financial statements for the years ended
December 31, 2010, 2009 and 2008.
Audit Fees
The fees for 2010 and 2009 from BDO for professional services rendered for the audit of our annual consolidated financial statements and internal
controls over financial reporting, quarterly and S-3 reviews were $343,100 and $408,500, respectively.
Tax Fees
The aggregate fees billed by BDO for professional services for tax compliance, tax advice and tax planning were $54,125 and $33,260 for 2010 and
2009, respectively.
All Other Fees
No other services were rendered by BDO for 2010 and 2009.
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 2010 and 2009.
63
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this 10-K:
(1) Financial Statements
PART IV
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-26 of this Annual Report. These consolidated financial statements are as follows:
Consolidated Balance Sheets as of December 31, 2010 and 2009
Consolidated Statements of Operations for the Years Ended December 31, 2010, 2009 and 2008
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2010, 2009 and 2008
Consolidated Statements of Cash Flows for the Years Ended December 31, 2010, 2009 and 2008
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-26 of this Annual Report.
Schedule II • Valuation and Qualifying Accounts for the years ended December 31, 2010, 2009 and 2008
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 65 of this Annual Report, which is incorporated herein by reference.
64
CytRx Corporation
Form 10-K Exhibit Index
Exhibit
Number Description
Footnote
2.1
3.1
3.2
4.1
4.2
4.3
4.4
4.5
10.1*
10.2*
10.3*
10.4*
10.5*
10.6*
10.7†
10.8†
10.9
10.10
10.11
10.12
Agreement and Plan of Merger, dated as of June 6, 2008, among CytRx Corporation, CytRx
Merger Subsidiary, Inc., Innovive Pharmaceuticals, Inc., and Steven Kelly
Restated Certificate of Incorporation of CytRx Corporation
Restated By-Laws of CytRx Corporation
Shareholder Protection Rights Agreement dated April 16, 1997 between CytRx Corporation and
American Stock Transfer &Trust Company, as Rights Agent
Amendment No. 1 to Shareholder Protection Rights Agreement, dated February 11, 2002
Amendment No. 2 to Shareholder Protection Rights Agreement, dated March 30, 2007
Securities Purchase Agreement, dated July 24, 2009, between CytRx Corporation and the
purchasers listed on the signature pages thereto
Form of Common Stock Purchase Warrant to be issued by CytRx Corporation to purchasers under
the Securities Purchase Agreement, dated July 24, 2009
CytRx Corporation 2000 Long-Term Incentive Plan
Amendment No. 1 to CytRx Corporation 2000 Long-Term Incentive Plan
Amendment No. 2 to CytRx Corporation 2000 Long-Term Incentive Plan
Amendment No. 3 to CytRx Corporation 2000 Long-Term Incentive Plan
Amendment No. 4 to CytRx Corporation 2000 Long-Term Incentive Plan
CytRx Corporation 2008 Stock Incentive Plan
License Agreement, dated December 7, 2001, by and between CytRx Corporation and Vical
Incorporated
Agreement between CytRx Corporation and Dr. Robert Hunter regarding SynthRx, Inc., dated
October 20, 2003
Office Lease between The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture,
dated April 13, 2000
Assignment, Assumption and Consent, effective July 1, 2003, by and among CytRx Corporation,
The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture, concerning Office Lease
dated April 13, 2000
Asset Sale and Purchase Agreement dated October 4, 2004, by and among CytRx Corporation,
Biorex Kutato Es Fejleszto RT., and BRX Research and Development Company Ltd
(x)
(a)
(a)
(b)
(g)
(s)
(aa)
(aa)
(e)
(h)
(h)
(i)
(i)
(z)
(f)
(i)
(i)
(i)
(k)
Sublease dated March 14, 2005 between Innovive Pharmaceuticals, Inc. and Friedman, Billings,
Ramsey Group, Inc.
(m)
65
10.13*
10.14
10.15†
10.16†
10.17
10.18†
10.19
10.20
10.21
10.22
10.23
10.24
Third Amended and Restated Employment Agreement dated May 17, 2005 between CytRx
Corporation and Steven A. Kriegsman
First Amendment to Office Lease dated October 14, 2005, by and between CytRx Corporation and
Douglas Emmett 1993, LLC
NS-187 License Agreement dated December 28, 2005 between Innovive Pharmaceuticals, Inc. and
Nippon Shinyaku Co., Ltd.
License Agreement dated April 17, 2006 between Innovive Pharmaceuticals, Inc. and KTB
Tumorforschungs GmbH
Royalty Agreement dated August 28, 2006 between CytRx Corporation and Kenneth R. Council, as
Trustee of the ALS Charitable Remainder Trust, dated August 28, 2006
License Agreement dated December 6, 2006 between Innovive Pharmaceuticals, Inc. and TMRC
Co., Ltd.
Form of Purchase Agreement, dated as of April 17, 2007, by and between CytRx Corporation and
each of the selling stockholders named therein
Second Amendment to Office Lease dated June 30, 2008, by and between CytRx Corporation and
Douglas Emmett 1993, LLC
Sub-Sublease dated December 4, 2008, by and between CytRx Oncology Corporation and Red Pine
Advisors LLC
Third Amendment to Office Lease dated December 1, 2009, by and between CytRx Corporation
and Douglas Emmett 1993, LLC
Stock Redemption Agreement dated as of March 22, 2010, by and between RXi Pharmaceuticals
Corporation and CytRx Corporation
Agreement for Clinical Services dated December 6, 2010, by and between CytRx Corporation and
Oncotherapeutics
(n)
(o)
(m)
(p)
(r)
(t)
(v)
(z)
(z)
(bb)
(cc)
10.25*
Employment Agreement dated January 1, 2011 between CytRx Corporation and Daniel Levitt,
M.D., Ph.D.
10.26*
Employment Agreement dated January 1, 2011, between CytRx Corporation and Scott Geyer
10.27*
Employment Agreement dated January 1, 2011, between CytRx Corporation and Benjamin S.
Levin
10.28*
Employment Agreement dated January 1, 2011, between CytRx Corporation and Scott Wieland
10.29*
Employment Agreement dated January 1, 2011, between CytRx Corporation and John Y. Caloz
23.1
31.1
31.2
32.1
32.2
Consent of BDO USA, LLP
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
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
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
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.
66
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(t)
(u)
(v)
(w)
(x)
(y)
(z)
(aa)
(bb)
(cc)
Incorporated by reference to the Registrant’s Form 10-K filed on April 1, 2008
Incorporated by reference to the Registrant’s 8-K filed on April 17, 1997
Incorporated by reference to the Registrant’s 10-Q filed on August 14, 1997
Incorporated by reference to the Registrant’s Proxy Statement filed on April 30, 1998
Incorporated by reference to the Registrant’s Form 10-K filed on March 27, 2001
Incorporated by reference to the Registrant’s Form 8-K filed on December 21, 2001
Incorporated by reference to the Registrant’s Form 10-K filed on April 1, 2002
Incorporated by reference to the Registrant’s Proxy Statement filed June 11, 2002
Incorporated by reference to the Registrant’s 10-K filed on May 14, 2004
Incorporated by reference to the Registrant’s 10-Q filed on August 16, 2004
Incorporated by reference to the Registrant’s 8-K filed on October 5, 2004
Incorporated by reference to the Registrant’s 8-K filed on January 21, 2005
Incorporated by reference to the CytRx Oncology Corp (f/k/a Innovive Pharmaceuticals, Inc.) Form 10 filed on April
20, 2006
Incorporated by reference to the Registrant’s 10-Q filed on August 15, 2005
Incorporated by reference to the Registrant’s 8-K filed on October 20, 2005
Incorporated by reference to the CytRx Oncology Corp (f/k/a Innovive Pharmaceuticals, Inc.) 10-Q filed on November
14, 2006
Incorporated by reference to the Registrant’s 8-K filed on March 3, 2006
Incorporated by reference to the Registrant’s 10-Q filed on November 13, 2006
Incorporated by reference to the Registrant’s 10-K filed on April 2, 2007
Incorporated by reference to the CytRx Oncology Corp (f/k/a Innovive Pharmaceuticals, Inc.) 10-K filed on March 21,
2007
Incorporated by reference to the Registrant’s 10-Q filed on May 10, 2007
Incorporated by reference to the Registrant’s 8-K filed on April 18, 2007
Incorporated by reference to the Registrant’s 10-Q filed on August 9, 2007
Incorporated by reference to the Registrant’s 8-K filed on June 9, 2008
Incorporated by reference to the Registrant’s 10-Q filed on August 11, 2008
Incorporated by reference to the Registrant’s 10-K filed on March 13, 2009
Incorporated by reference to the Registrant’s 8-K filed on July 27, 2009
Incorporated by reference to the Registrant’s 8-K filed on December 4, 2009
Incorporated by reference to the RXi Pharmaceuticals Corporation Current Report on Form 8-K filed on March 23,
2010
67
In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SIGNATURES
Date: March 11, 2011
CYTRX CORPORATION
By: /s/ STEVEN A. KRIEGSMAN
Steven A. Kriegsman
President and Chief Executive Officer
In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the
capacities and on the dates indicated.
Signature
/s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
/s/ JOHN Y. CALOZ
John Y. Caloz
Director, President and Chief Executive Officer
Title
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial Officer and Principal Accounting
Officer)
/s/ MAX LINK
Max Link, Ph.D.
Chairman of the Board
/s/ MARVIN R.
SELTER
Marvin R. Selter
Vice-Chairman of the Board
/s/ LOUIS IGNARRO Director
Louis Ignarro, Ph.D.
/s/ JOSEPH
RUBINFELD
Joseph Rubinfeld, Ph.D.
/s/ RICHARD L. WENNEKAMP
Richard L. Wennekamp
Director
Director
68
Date
March 11, 2011
March 11, 2011
March 11, 2011
March 11, 2011
March 11, 2011
March 11, 2011
March 11, 2011
INDEX TO FINANCIAL STATEMENTS
AND FINANCIAL STATEMENT SCHEDULE
CytRx Corporation
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Reports of Independent Registered Public Accounting Firm
Financial Statement Schedule II • Valuation and Qualifying Accounts
F-2
F-3
F-4
F-5
F-6
F-21
F-23
Current assets:
Cash and cash equivalents
Marketable securities
Proceeds from sale of RXi, received January 6, 2011
Receivable
Income taxes recoverable
Interest receivable
Assets held for sale
Prepaid expenses and other current assets
Total current assets
Equipment and furnishings, net
Goodwill
Other assets
Total assets
CYTRX CORPORATION
CONSOLIDATED BALANCE SHEETS
ASSETS
December 31,
2010
2009
$
6,324,430 $
20,567,861
6,938,603
259,006
519,158
117,624
•
1,247,145
35,973,827
319,191
183,780
220,292
9,893,590
22,750,000
•
139,680
519,158
130,779
73,634
1,088,074
34,594,915
174,959
183,780
323,235
$ 36,697,090 $ 35,276,889
Current liabilities:
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable
Accrued expenses and other current liabilities
Warrant liabilities
Total current liabilities
Commitment and contingencies
Stockholders’ equity:
$
1,027,924 $
2,663,910
2,437,281
6,129,115
1,066,055
2,492,450
3,370,701
6,929,206
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; 109,840,445 and 109,538,821 shares issued and
•
•
outstanding at December 31, 2010 and 2009, respectively
Additional paid-in capital
Treasury stock, at cost (633,816 shares held, at December 31, 2010 and 2009, respectively)
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
The accompanying notes are an integral part of these consolidated financial statements.
F-2
109,840
(2,279,238)
109,539
229,253,122 227,441,591
(2,279,238)
(196,515,749) (196,924,209)
28,347,683
$ 36,697,090 $ 35,276,889
30,567,975
`CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
Revenue:
Service revenue
Licensing revenue
Expenses:
Research and development
General and administrative
In-process research and development
Depreciation and amortization
Loss before other income
Other income:
Interest and dividend income
Other income, net
Gain on warrant derivative liability
Gain on sale of affiliate’s shares - RXi Pharmaceutical
Equity in loss of affiliate – RXi Pharmaceutical
Net profit (loss) before provision for income taxes
Income tax benefit (expense)
Net profit (loss)
Deemed dividend for anti-dilution adjustments made to outstanding common stock warrants
Net profit (loss)
Add: Loss of noncontrolling interest
Net profit (loss) attributable to CytRx Corporation
Basic and diluted profit (loss) per share
Basic weighted average shares outstanding
Diluted weighted average shares outstanding
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Years Ended December 31,
2009
2010
2008
$
• $ 9,400,397 $ 6,166,150
100,000
6,266,150
100,000
100,000
100,000 9,500,397
8,506,937 7,541,998 10,465,591
8,235,993 9,127,845 10,932,522
8,012,154
624,980
16,850,596 17,145,159 30,035,247
(16,750,596) (7,644,762) (23,769,097)
•
107,666
•
475,316
303,592
95,827
933,420
349,490
93,950
656,905
15,826,217 1,224,951
•
•
1,203,629
219,489
•
•
(3,915,514)
•
•
•
408,460 (5,319,466) (26,261,493)
(873,003)
519,158
408,460 (4,800,308) (27,134,496)
(756,954)
408,460 (4,800,308) (27,891,450)
88,375
408,460 $ (4,800,308) $(27,803,075
$
(0.30)
$
109,484,492 99,978,124 91,383,934
111,442,278 99,978,124 91,383,934
(0.05) $
0.00 $
•
•
CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Additional
Paid-In
Shares Issued Amount Capital
Common Stock
Accumulated Treasury Noncontrolling
Stock
Interest
Deficit
Total
Balance at December 31, 2007
90,397,867 $ 90,398 $203,905,691 $(161,492,812) $(2,279,238) $
(448,671) $ 40,312,414
Issuance of stock options/warrants for
compensation, services and licenses
Options and warrants exercised
Common stock issued in connection with the
acquisition of Innovive
Deemed dividend for anti-dilution adjustment
Dividend of RXi stock
Net loss
Balance at December 31, 2008
Common stock and warrants issued in connection
with private placements
Issuance of stock options/warrants for
compensation and services
Common stock issued for services
Options and warrants exercised
Net loss
Balance at December 31, 2009
Issuance of stock options/warrants for
compensation and services
Common stock issued for services
Options and warrants exercised
Net profit
Balance at December 31, 2010
•
1,006,402
•
1,006
2,029,209
975,782
•
•
•
•
2,029,209
976,788
2,574,179
•
•
•
•
93,978,448 $ 93,978 $210,007,468 $(192,123,901) $(2,279,238) $
•
(756,954)
(2,828,014)
(27,046,121)
2,339,832
756,954
•
•
2,574
•
•
•
•
•
2,342,406
•
(2,828,014)
(88,375) (27,134,496)
• $ 15,698,307
15,252,040 15,253 14,230,710
•
•
14,245,963
•
50,000
258,333
•
•
•
•
•
109,538,821 $109,539 $227,441,591 $(196,924,209) $(2,279,238) $
•
•
•
(4,800,308)
2, 867,638
42,950
292,825
•
•
50
258
•
•
50,000
251,624
•
•
•
•
•
109,840,445 $109,840 $229,253,122 $(196,515,749) $(2,279,238) $
1,620,088
44,450
146,993
•
•
•
•
408,460
•
50
251
•
2,867,638
43,000
293,083
•
(4,800,308)
• $ 28,347,683
1,620,088
44,500
147,244
•
408,460
• $ 30,567,975
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,
2009
2010
2008
Cash flows from operating activities:
Net profit (loss) attributable to CytRx Corporation
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Retirement of fixed assets
Interest receivable on marketable securities
Loss of noncontrolling interest
Fair value adjustment of warrant liability
Impairment loss on fixed assets
Equity in loss of affiliate
Non-cash gain on transfer of RXi common stock
Gain on sale of affiliate’s shares
Non-cash expense on the acquisition of Innovive’s in-process research & development
Stock option and warrant expense
Common stock issued for services
Changes in assets and liabilities:
Accounts receivable
Interest receivable
Income taxes recoverable
Prepaid expenses and other current assets
Accounts payable
Deferred revenue
Accrued expenses and other current liabilities
Total adjustments
Net cash used in operating activities
Cash flows from investing activities:
Net Proceeds (Purchase) from sale of marketable securities
Proceeds from sale of fixed assets
Proceeds from sale of assets held for sale
Deconsolidation of subsidiary
Proceeds from sale of RXi shares
Cash outlay in the acquisition of Innovive, relating to its accounts payable
Purchases of equipment and furnishings
Net cash provided by (used in) investing activities
Cash flows from financing activities:
Net proceeds from exercise of stock options and warrants
Common stock issued in accordance with financing
Net proceeds from issuances of common stock
Capital contributions from minority interest
Net cash provided by financing activities
Net decrease in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
Supplemental disclosure of cash flow information:
Cash paid during the years for income taxes
Supplemental disclosures of non-cash financing activities:
Acquisition of property and equipment through accrued liabilities
Warrants issued in connection with financing
Warrants issued for prepaid services
$
408,460 $ (4,800,308) $(27,046,121)
107,666
63,853
•
•
(933,420)
•
•
•
(15,826,217)
•
1,620,088
44,450
475,316
103,241
•
•
(656,905)
1,187,305
•
•
(1,224,951)
•
2,867,638
43,000
624,980
262
(48,452)
(88,375)
•
•
3,915,515
(226,579)
•
8,012,154
2,103,752
244,860
238,131
(119,326)
•
13,155
(215,623)
•
478,965
(56,127)
(1,181,116)
(38,131)
(6,166,151)
•
(56,146)
171,459
(14,952,550)
7,636,177
(14,544,090) (12,114,264) (19,409,944)
(12,400)
(130,779)
303,535
(594,668)
397,633
(9,400,397)
(64,454)
(7,313,956)
2,182,139 (22,750,000) 10,000,000
•
119,929
•
•
• (10,359,278)
•
(5,669,749)
(994,326)
(7,023,353)
1,224,951
•
(195,449)
10,827,636 (21,600,569)
•
73,634
•
8,887,614
•
(315,751)
147,294
293,083
• 18,273,568
•
•
•
•
147,294 18,566,651
976,808
•
•
•
976,808
(3,569,160) (15,148,182) (25,456,489)
9,893,590 25,041,772 50,498,261
$ 6,324,430 $ 9,893,590 $ 25,041,772
$
$
$
$
• $
• $ 1,093,764
• $
• $
• $ 4,027,606 $
133,391 $
• $
130,955
•
•
The accompanying notes are an integral part of these consolidated financial statements. See supplemental information on the following page.
F-5
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, specializing in oncology. CytRx’s drug development pipeline includes clinical development of three product candidates for cancer
indications, including recently-initiated Phase 2 proof-of-concept clinical trials with bafetinib in patients with advanced prostate cancer and high-risk B-cell
chronic lymphocytic leukemia, or B-CLL, an additional pharmacokinetic clinical trial with bafetinib in patients with brain cancer, two planned Phase 2
clinical trials for INNO-206 as a treatment for soft tissue sarcomas and pancreatic cancer following an abbreviated safety trial, and clinical trials with
tamibarotene for the treatment of non-small-cell lung cancer and acute promyelocytic leukemia, or APL. In addition to our core oncology programs, we own
rights to two drug candidates based on our molecular chaperone regulation technology, which are designed to repair or degrade mis-folded proteins associated
with disease. Our current business strategy is to seek one or more strategic partnerships to pursue the development of that technology or an outright sale of the
assets.
At December 31, 2010, the Company had cash and cash equivalents of approximately $6.3 million, marketable securities of $20.6 million and proceeds
from sale of balance of RXi shares of $6.9 million. Management believes that the Company’s current cash on hand, together with its marketable securities and
proceeds from sale of RXI shares, will be sufficient to fund its operations for the foreseeable future. The estimate is based, in part, upon the Company’s
currently projected expenditures for 2011 of approximately $20.1 million (unaudited), which includes approximately $3.5 million (unaudited) for its clinical
programs for INNO-206, approximately $2.2 million (unaudited) for its clinical programs for bafetinib, approximately $5.5 million (unaudited) for its clinical
program for tamibarotene, approximately $2.0 million (unaudited) for general operation of its clinical programs, and approximately $6.8 million (unaudited)
for other general and administrative expenses. These projected expenditures are also based upon numerous other assumptions and subject to many
uncertainties, and 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.
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. 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 “noncontrolling 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 recorded 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 13 below). The investment balance in RXi was eventually reduced to zero and the Company stopped
recording its share of losses from RXi. As a consequence of the Company’s subsequent sales of common stock of RXi, the Company began to account for
those shares as available for sale, and any increases or decreases were included as part of comprehensive income or loss and shown on the balance sheet at
market value, based on RXi’s closing stock price. The Company disposed of all of its remaining shares of RXi in December 2010.
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 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 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.
F-6
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, the Company 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 the Company. The Company has
concluded that due to the research and development components of the transaction that it is properly accounted for under ASC 730-20 (previously Statement
of Financial Accounting Standards No. 68, Research and Development Arrangements). Accordingly, the Company recorded the value received under the
arrangement as deferred service revenue and recognized service revenue using the proportional performance method of revenue recognition, meaning that
service revenue was 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. CytRx believes that this method best approximates the efforts expended related to the services provided. The Company adjusted its
estimates of expense incurred for this research and development on a quarterly basis.
Pursuant to an amendment signed between the Company and the beneficiary of the ALSCRT on August 6, 2009, the Company was released from all
restrictions on the use of any proceeds previously received by us in connection with the arrangement. As a result, the Company recognized $6.7 million as
service revenue in the third quarter of 2009, which represented the remaining deferred revenue and previously un-recognized portion of the value received.
For the years ended December 31, 2009 and 2008, the Company recognized approximately $9.4 million and $6.2 million, respectively, of service revenue
related to this transaction. No service revenue related to the ALSCRT transaction was recognized in 2010.
Other Income • The Company realized a net gain of $0.1 million in both 2010 and 2009 on the sub-lease of its New York city rental property inherited
on the acquisition of Innovive. 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.
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.
Marketable securities • Investment securities held by the Company are classified as available for sale.
Proceeds from sale of RXi • In December, 2010, the Company sold its remaining RXi shares of 3.1 million for net proceeds of approximately $6.9
million. These funds were deposited in the Company’s cash account on January 6, 2011.
Fair Value of Financial Instruments • The carrying amounts reported in the balance sheet for cash and cash equivalents and marketable securities
approximate their fair values.
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 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.
F-7
Fair Value Measurements • Assets and liabilities recorded at fair value in balance sheets are categorized based upon the level of judgment associated
with the inputs used to measure the fair value. Level inputs 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, 2010 for assets and liabilities measured
at fair value on a recurring basis:
(In thousands)
Cash and cash equivalents
Marketable securities
Proceeds from sale of RXi
Warrant Liability
$
Level I
6,324
$
20,568
6,939
•
Level II
•
$
•
•
2,437
Level III
•
$
•
•
•
Total
6,324
20,568
6,939
2,437
The following table summarizes fair value measurements by level at December 31, 2009 for assets and liabilities measured at fair value on a recurring
basis:
(In thousands)
Cash and cash equivalents
Marketable securities
Warrant Liability
$
Level I
9,894
$
22,750
•
Level II
•
$
•
3,371
Level III
•
$
•
•
Total
9,894
22,750
3,371
Liabilities measured at market value on a recurring basis include warrant liabilities resulting from recent debt and equity financing. In accordance with
ASC 815-40 (formerly EITF 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock), the
warrant liabilities are being marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method,
using assumptions consistent with the Company’s application of ASC 505-50. See Warrant Liabilities below.
The Company considers carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term
nature of these financial instruments.
The Company’s non-financial assets, such as assets held for sale are measured at fair value when there is an indicator of impairment and recorded at fair
value only when an impairment charge is recognized. The Company sold all of its remaining assets held for sale in 2010. The following table summarizes the
Company’s financial assets measured at fair value on a nonrecurring basis as of December 31, 2009:
(in thousands)
Level 1
Level 2
Level 3 Total Losses
Long-lived assets held for sale:
Plant and equipment, net
$
•
$
74
$
• $
1,187
The long-lived assets held for sale in 2009 relate to the Company’s equipment held in its San Diego research facility, which it closed in 2009. The
Company recorded an impairment charge of $1,187 as a result of this closure.
Fair Value Measurements
as of December 31, 2009
F-8
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. In the third quarter of 2009, the remaining fixed assets from the Company’s San Diego
laboratory were re-allocated from Equipment and Furnishings to Assets Held for Sale and were all sold in 2010. (see Note 7 below).
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.
Net Income (Loss) Per Share • Basic net income (loss) per common share is computed using the weighted-average number of common shares
outstanding. Diluted net income (loss) per common share is computed using the weighted-average number of common share and common share equivalents
outstanding. 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 15.4 million, 24.4 million shares, and 15.2 million shares at December 31, 2010, 2009 and 2008, respectively.
As a result of the March 11, 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. The deemed dividend was 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.
Warrant Liabilities • Liabilities measured at market value on a recurring basis include warrant liabilities resulting from our recent equity financing. In
accordance with ASC 815-40 (formerly EITF (Emerging Issues Task Force) 00-19, Accounting for Derivative Financial Instruments Indexed to and
Potentially Settled in a Company’s Own Stock, the warrant liabilities are being marked to market each quarter-end until they are completely settled. The
warrants are valued using the Black-Scholes method. The warrants do not contain any down round provisions. The gain or loss resulting from the marked to
market calculation is shown on the Consolidated Statements of Operations as Gain on warrant derivative liability.
Shares Reserved for Future Issuance • As of December 31, 2010, the Company has reserved approximately 7.4 million of its authorized but unissued
shares of common stock for future issuance pursuant to its employee stock option plans issued to employees and consultants.
Stock-based Compensation • The Company’s stock-based employee compensation plans are described in Note 14. The Company has adopted the
provisions of ASC 718 (previously SFAS No. 123(R), Share-Based Payment (“SFAS 123(R)”)), which requires the measurement and recognition of
compensation expense for all stock-based awards made to employees and non-employees.
For stock options and stock warrants paid in consideration of services rendered by non-employees, the Company recognizes compensation expense in
accordance with the requirements of ASC 718 (previously SFAS No. 123(R)), ASC 505-50 (previously 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
ASC 505 (previously 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 or warrants are fully
vested.
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.
F-9
Clinical Trial Expenses • Clinical trial expenses, which are included in research and development expenses, include obligations resulting from the
Company’s contracts with various clinical research organizations in connection with conducting clinical trials for its product candidates. The Company
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. The Company believe that this method best approximates the efforts expended on
a clinical trial with the expenses it records. The Company adjusts its rate of clinical expense recognition if actual results differ from its estimates. If its
estimates are incorrect, clinical trial expenses recorded in any particular period could vary.
Income Taxes • The company accounts for income taxes in accordance with the provisions of FASB ASC Topic 740-10, Income Taxes, (“ASC 740”)
which 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. Under this method, a two-step process, the first step is to determine whether or not a tax benefit should be
recognized A tax benefit will be recognized if the weight of available evidence indicates that the tax position is more likely than not to be sustained upon
examination by the relevant tax authorities. The recognition and measurement of benefits related to our tax positions requires significant judgment, as
uncertainties often exist with respect to new laws, new interpretations of existing laws, and rulings by taxing authorities. Differences between actual results
and our assumptions or changes in our assumptions in future periods are recorded in the period they become known.
Concentrations of Risks • Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of
cash, cash equivalents and marketable securities. 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 marketable securities. Cash and cash equivalents are maintained at financial
institutions and, at times, balances may exceed federally insured limits. We have never experienced any losses related to these balances. All of our non-
interest bearing cash balances were fully insured at December 31, 2010 due to a temporary federal program in effect from December 31, 2010 through
December 31, 2012. Under the program, there is no limit to the amount of insurance for eligible accounts. Beginning 2013, insurance coverage will revert to
$250,000 per depositor at each financial institution, and our non-interest bearing cash balances may again exceed federally insured limits. Interest-bearing
amounts on deposit in excess of federally insured limits at December 31, 2010 approximated $5.6 million.
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.
Other comprehensive income/(loss) • The Company follows the provisions of ASC 220, (formerly 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 May 2009 and February 2010, the FASB issued new guidance for accounting for subsequent events. The new guidance, which is now part of ASC
855-10, Subsequent Events (formerly, SFAS No. 165, Subsequent Events) is consistent with existing auditing standards in defining subsequent events as
events or transactions that occur after the balance sheet date but before the financial statements are issued or are available to be issued. The new guidance
defines two types of subsequent events: “recognized subsequent events” and “non-recognized subsequent events.” Recognized subsequent events provide
additional evidence about conditions that existed at the balance sheet date and must be reflected in the company’s financial statements. Non-recognized
subsequent events provide evidence about conditions that arose after the balance sheet date and are not reflected in the financial statements of a company.
Certain non-recognized subsequent events may require disclosure to prevent the financial statements from being misleading. The new guidance was effective
on a prospective basis for interim or annual periods ending after June 15, 2009. The Company adopted the provisions of ASC 855-10 as required.
In June 2009, the FASB amended ASC 860, (formerly SFAS No. 166, Accounting for Transfers of Financial Assets, an amendment to SFAS No. 140).
ASC 860 eliminates the concept of a “qualifying special-purpose entity,” changes the requirements for derecognizing financial assets, and requires additional
disclosures in order to enhance information reported to users of financial statements by providing greater transparency about transfers of financial assets,
including securitization transactions, and an entity’s continuing involvement in and exposure to the risks related to transferred financial assets. ASC 860 is
effective for fiscal years beginning after November 15, 2009. The adoption of ASC 860 had no impact on its financial statements.
F-10
In June 2009, the FASB amended ASC 810 (formerly SFAS No.167, Amendments to FASB Interpretation No. 46). The amendments include: (1) the
elimination of the exemption for qualifying special purpose entities, (2) a new approach for determining who should consolidate a variable-interest entity, and
(3) changes to when it is necessary to reassess who should consolidate a variable-interest entity. ASC 810 is effective for the first annual reporting period
beginning after November 15, 2009 and for interim periods within that first annual reporting period. The adoption of ASC 810 did not have a material impact
on its financial statements.
In June 2009, the FASB issued new guidance which is now part of ASC 105-10 (formerly Statement of Financial Accounting Standards No. 168, The
FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles ). ASC 105-10 replaces FASB Statement No. 162,
The Hierarchy of Generally Accepted Accounting Principles, and establishes the FASB Accounting Standards Codification as the source of authoritative
accounting principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in conformity with
generally accepted accounting principles. ASC 105-10 is effective for interim and annual periods ending after September 15, 2009. The adoption of ASC
105-10 did not have a material impact on the Company’s financial statements.
In January, 2010, the FASB issued ASU 2010-06, Improving Disclosures about Fair Value Measurements. The standard amends ASC Topic 820, Fair
Value Measurements and Disclosures to require additional disclosures related to transfers in and out of Levels 1 and 2 and for activity in Level 3 and clarifies
other existing disclosures requirements. The Company adopted ASU 2010-06 beginning January 1, 2010. This update had no impact on the Company’s
financial statements.
In April 2010, the FASB issued Accounting Standard Update (“ASU”) No. 2010-17, Milestone Method of Revenue Recognition, which provides
guidance on applying the milestone method to milestone payments for achieving specified performance measures when those payments are related to
uncertain future events. However, the FASB clarified that, even if the requirements in this ASU are met, entities would not be precluded from making an
accounting policy election to apply another appropriate accounting policy that results in the deferral of some portion of the arrangement consideration. The
ASU is effective for periods beginning on or after June 15, 2010. Entities can apply this guidance retrospectively as well as prospectively to milestones
achieved after adoption. This update had no impact on the Company’s financial statements.
4. Receivable
At December 31, 2010, the Company had a receivable of $259,006, $98,000 relating to a nontaxable grant under the Qualifying Therapeutic Discovery
Project Program and the balance primarily related to annual licensing fees due to the Company. At December 31, 2009, the receivable of $139,680 primarily
related to annual licensing fees due to the Company. Due to the certainty of the collectability of the accounts receivable, no allowance was recorded.
5. Prepaid and Other Assets
At December 31, 2010 and 2009, the Company had $220,292 and $323,235, 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.
6. Marketable securities
The Company held $20.6 million of marketable securities at December 31, 2010. The Company has classified these investments as available for
sale. These investments are comprised of federally insured certificates of deposit and these four accounts detailed as follows: $5.0 million with a maturity
date of January 27, 2011, $7.6 million with a maturity date of March 31, 2011, $5.0 million with a maturity date of July 14, 2011, and $3.0 million with a
maturity date of July 28, 2011.
7. Assets Held for Sale
In May 2009, the Company substantially completed the initial phase of the closure of its drug discovery research at its laboratory facility in San Diego,
California. The Company concluded that it would conduct its research and development activities through third parties for the foreseeable future. The
Company sublet the laboratory facility until its lease expired in October, 2010, and sold the laboratory equipment. In the third quarter of 2009, the fixed
assets related to the San Diego laboratory were re-allocated from Equipment and Furnishings to Assets Held for Sale and were written down to their estimated
net realizable value as of September 30, 2009, which resulted in a charge of $1.2 million for that quarter. During 2010, the balance of the assets held for sale
were sold.
F-11
Assets held for sale consisted of the following:
(in thousands)
Assets:
Plant and equipment, net
Assets held for sale
December 31,
2009
$
$
74
74
8. Equipment and Furnishings
Equipment and furnishings at December 31, 2010 and 2009 consist of the following (in thousands):
Equipment and furnishings
Less • accumulated depreciation
Equipment and furnishings, net
$
2010
2009
$
398
(79)
319
334
(159)
175
Depreciation and amortization expense for the years ended December 31, 2010, 2009 and 2008 were approximately $108,000, $475,000, and $625,000,
respectively.
9. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities at December 31, 2010 and 2009 are summarized below (in thousands).
Professional fees
Research and development costs
Wages, bonuses and employee benefits
Income taxes
Other
Total
10. Warrant Liabilities
2010
2009
$
$
423 $
2,031
158
•
52
2,664 $
423
1,255
208
•
606
2,492
Liabilities measured at market value on a recurring basis include warrant liabilities resulting from the Company’s past equity financing. In accordance
with the guidance which is now ASC 815-40 (formerly EITF (Emerging Issues Task Force) 00-19, Accounting for Derivative Financial Instruments Indexed
and Potentially Settled in a Company’s Own Stock), the warrant liabilities are being marked to market each quarter-end until they are completely settled. The
warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50. The gain or loss resulting from the
marked to market calculation is shown on the Consolidated Statements of Operations as Gain on warrant derivative liability. The Company recognized gains
of $933,000 and $657,000 in 2010 and 2009, respectively.
11. 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.
F-12
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.
CytRx’s current contractual obligations that will require future cash payments are as follows (in thousands):
Operating Leases (1)(2)
$
Employment Agreements (3)
Subtotal Research and Development (4)
2011
2012
2013
2014
2015 and thereafter
Total
____________
$
547 $
471
332
386
55
1,791 $
2,455 $
•
•
•
•
2,455 $
3,002 $
471
332
386
55
4,246 $
Tota
8,667 $ 11,669
3,711
3,240
332
•
386
•
55
•
11,907 $ 16,153
(1) Operating leases are primarily facility lease related obligations, as well as equipment lease obligations with third party vendors.
(2) The Company is entitled to receive future rental income under subleases in place which would be offset against future operating lease obligations as
follows: $350,000 in 2011 and $235,000 in 2012.
(3) 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.
(4) Research and development obligations relate primarily to clinical trials. Most of these purchase obligations are cancelable.
The Company applies the disclosure provisions of ASC 460 (formerly FASB Interpretation No. 45, Guarantor’s Accounting and Disclosure
Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others), 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 ASC 460.
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.
12. 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 ASC 470 (previously Emerging Issues Task Force Issue (“EITF”) No. 98-5, Accounting for Convertible Securities
with Beneficial Conversion Features or Contingently Adjustable Conversion Ratio)s, and ASC 470 (previously EITF 00-27, Application of 98-5 to Certain
Convertible Instruments), and recorded an approximate $757,000 charge to accumulated deficit and a corresponding credit to additional paid-in capital.
F-13
On July 27, 2009, the Company completed a $20.0 million registered direct public offering in which it issued approximately 15.3 million shares of its
common stock at a price of $1.31 per share, and warrants to purchase an additional approximately 4.7 million shares of common stock at an exercise price of
$1.70 per share. Net of investment banking commissions, advisory fees, legal, accounting and other fees related to the transaction, the Company received
proceeds of approximately $18.3 million (without giving effect to any proceeds that may in the future be received by the Company upon exercise of warrants
sold in the offering). Immediately after the sale, the Company had approximately 109.5 million shares of common stock outstanding, without giving effect to
the possible exercise of the warrants sold in the offering or any of our other outstanding warrants or stock options.
13. Investment 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 “noncontrolling interests.” The Company offset $88,000 of loss in noncontrolling interest of RXi against its net loss for the
months of January and February 2008.
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 the Company’s ownership to less than 50% of RXi. As a result, the Company began to account for its investment in
RXi using the equity method, under which the Company recorded only its pro-rata share of the financial results of RXi. In 2009, the investment balance in
RXi was reduced to zero and the Company has not made any advances or guarantees to RXi. Therefore the Company stopped recording its share of losses
from RXi.
In June, 2010, the Company sold 2.0 million common shares of RXi and in December, 2010, disposed of its remaining shares for approximately $6.9
million.
14. Stock Options and Warrants
CytRx Options
The Company has a 2000 Long-Term Incentive Plan under which 10.0 million shares of common stock were originally reserved for issuance. As of
December 31, 2010, there were approximately 7.2 million shares subject to outstanding stock options. This plan expired on August 6, 2010, and thus no
further shares are available for future grant under this plan.
The Company also has a 2008 Stock Incentive Plan under which 10.0 million shares of common stock were originally reserved for issuance. As of
December 31, 2010, there were 2.6 million shares subject to outstanding stock options and 7.4 million shares available for future grant under this plan.
The Company has adopted the provisions of ASC 718 (previously SFAS No. 123(R), Share-Based Payment (“SFAS 123(R)”)), which requires the
measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees.
For stock options and stock warrants paid in consideration of services rendered by non-employees, the Company recognizes compensation expense in
accordance with the requirements of ASC 718 (previously SFAS No. 123(R)), ASC 505-50 (previously 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
ASC 505 (previously 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, 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.
At the Annual Meeting of Stockholderss held on July 1, 2009, the Company’s stockholders approved an amendment to the Company’s 2000 Long-Term
Incentive Plan to allow for a one-time stock option re-pricing program for employees and officers. Pursuant to the re-pricing program, 3,265,500 eligible
stock options held by ten eligible employees and officers were amended to reduce the exercise prices of the options to $1.15 per share, which was the closing
sale price of the Company’s common stock as reported on the Nasdaq Capital Market on the July 1, 2009 completion date of the re-pricing program, and to
impose a new option vesting schedule. None of the amended options vested immediately. To the extent a participating employee’s or officer’s eligible
options were vested on the amendment date, the amended options vested in full on December 31, 2009, so long as the employee or officer remained in the
Company’s employ through that date. To the extent a participating employee’s or officer’s eligible options were unvested as of July 1, 2009, the original
scheduled vesting was suspended until December 31, 2009 and resumed after that date, so long as the employee or officer remained in the Company’s employ
through such date. The incremental cost of the re-pricing program was approximately $0.4 million.
F-14
ASC 718 (previously SFAS No. 123(R)) requires the re-pricing of equity awards to be treated as the repurchase of the old award for a new award of
equal or greater value, incurring additional compensation cost for any incremental value. This incremental difference in value is measured as the excess of the
fair value of the modified award determined in accordance with the provisions of ASC 718 over the fair value of the original award immediately before its
terms are modified, measured based on the share price and other pertinent factors at that date. ASC 718 provides that this incremental fair value, plus the
remaining unrecognized compensation cost from the original measurement of the fair value of the old option, must be recognized over the remaining vesting
period.
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:
Risk-free interest rate
Expected volatility
Expected lives (years)
Expected dividend yield
2010
2009
2008
2.50%
91%
6
0.00%
1.95%
97%
6
0.00%
2.68%
102%
6
0.00%
The Company’s computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For option grants issued during
years ended December 31, 2010, 2009 and 2008, the Company used a calculated volatility for each grant. The Company’s computation of expected lives was
estimated using the simplified method provided for under ASC 718 (previously 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 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 year ended December 31, 2010, the Company has estimated an annualized forfeiture rate of 13% for options granted to its
employees, 2% for options granted to senior management and 0% for options granted to directors. For the years ended December 31, 2009 and 2008, the
Company has estimated an annualized forfeiture rate of 14% and 10%, respectively, for options granted to its employees, 2% and 3%, respectively, for
options granted to senior management and 0% and 0%, respectively, 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.
At December 31, 2010, there remained approximately $3.0 million of unrecognized compensation expense related to unvested stock options granted to
current and former employees and directors, to be recognized as expense over a weighted-average period of 1.11 years. Presented below is the Company’s
stock option activity for employees and directors:
Outstanding • beginning of year
Granted
Exercised
Forfeited
Expired
Outstanding • end of year
Exercisable at end of year
Weighted average fair value of stock options granted during the year:
2010
8,012,090
1,715,500
(223,633)
(626,497)
•
8,877,460
5,701,946
0.75 $
Stock Options
2009
6,409,940
2,351,000
(8,333)
(713,018)
(27,499)
8,012,090
4,998,400
0.77 $
$
Weighted Average
Exercise Price
2008
2010 2009 2008
4,932,273 $ 1.99 $ 1.99 $ 2.46
2,021,500 0.98 1.00 0.79
(54,737) 0.66 0.37 0.92
(473,096) 1.01 2.57 2.08
• 1.07 1.00
(16,000)
6,409,940 1.07 1.02 1.99
4,109,839 $ 0.99 $ 1.16 $ 2.07
0.63
F-15
A summary of the activity for unvested employee stock options as of December 31, and changes during the year are presented below:
Nonvested at January 1,
Granted
Vested
Pre-vested forfeitures
Nonvested at December 31,
2010
3,013,690
1,715,500
(927,179)
(626,497)
3,175,514
Stock Options
2009
2,300,100
2,351,000
(924,392)
(713,018)
3,013,690
Weighted Average
Grant Date Fair
Value per Share
2009
2008
2008
2010
1,721,952 $
2,021,500
(970,256)
(473,096)
2,300,100 $
0.70 $
0.75
0.75
0.62
0.75 $
1.52 $
0.77
2.10
2.11
0.70 $
2.92
0.63
2.10
1.74
1.52
For stock options paid in consideration of services rendered by non-employees, the Company recognizes compensation expense in accordance with the
requirements of ASC 718, ASC 503-50 (formerly 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 formerly 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.
The Company recorded approximately $0.4 million, $0 and ($0.4) million of non-cash charges (recovery) related to the issuance of stock options to
certain consultants in exchange for services during 2010, 2009 and 2008, respectively.
At December 31, 2010, there remained approximately $30,000 (subject to change in the future based on vesting date fair value) of unrecognized
compensation expense related to unvested non-employee stock options to be recognized as expense over a weighted-average period of 1.0 years. Presented
below is the Company’s non-employee stock option activity:
Outstanding • beginning of year
Granted
Exercised
Forfeited
Expired
Outstanding • end of year
Exercisable at end of year
Weighted average fair value of stock options granted during the year:
2010
995,000
395,000
•
•
(395,000)
995,000
707,541
0.87 $
Stock Options
2009
995,000
•
•
•
•
995,000
545,080
0 $
$
Weighted Average
Exercise Price
2010 2009 2008
2008
1,067,000 $ 0.91 $ 0.91 $ 1.44
• 0.35
350,000 1.22
•
•
•
•
• 1.85
(402,000)
•
• 0.30
(20,000) 1.28
0.9 0.91 0.91
995,000
445,000 $ 1.00 $ 1.00 $ 1.18
0.33
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:
Risk-free interest rate
Expected volatility
Expected lives (years)
Expected dividend yield
2010
2009
2008
2.37%
92%
5
0%
•
•
•
•
2.68%
123%
10
0%
F-16
A summary of the activity for nonvested, non-employee stock options as of December 31, and changes during the years are presented below:
Nonvested at January 1,
Granted
Vested
Pre-vested forfeitures
Nonvested at December 31,
Stock Options
2009
2008
2010
Weighted Average
Grant Date Fair
Value per Share
2009
2008
550,000
•
(100,080)
•
449,920
250,000 $
350,000
(50,000)
•
550,000 $
1.38 $
0.87
0.33
1.12
1.98 $
0.58 $
•
0.33
•
1.38 $
1.00
0.33
2.33
•
0.58
2010
449,920
395,000
(162,461)
(395,000)
287,459
The following table summarizes significant ranges of outstanding stock options under the three plans at December 31, 2010:
Range of
Exercise Prices
0.30 • 1.00
$
1.01 • 1.50
$
2.35 • 3.33
$
Number of Options
2,152,607
7,127,983
528,000
9,808,590
Weighted Average
RemainingContractual Life
(years)
Weighted Average
Exercise Price
Number of
Options
Exercisable
1,703,405
4,160,212
528,000
0.59
1.10
2.27
1.05
6,391,617
Weighted Average
Contractual Life
Weighted Average
Exercise Price
7.22 $
7.00
3.55
6.86 $
0.61
1.14
2.27
1.09
7.22 $
7.00
3.55
6.86 $
The aggregate intrinsic value of outstanding options as of December 31, 2010 was $1.1 million, which represents options whose exercise price was less
than the closing fair market value of the Company’s common stock on December 31, 2010 of $1.01.
RXi Pharmaceuticals
RXi has its own stock option plan. RXi accounted for stock option expense in the same manner as CytRx as described above.
As discussed in Note 2, the Company accounted for its investment in RXi under the equity method from March 2008 through June 2009, 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 consolidated statements of operations:
Research and development • employee
General and administrative • employee
Total employee stock-based compensation
2008
$ 28,000
369,000
$397,000
Research and development • non-employee
General and administrative • non-employee
$121,000
•
Total non-employee stock-based compensation $121,000
CytRx Warrants
A summary of the Company’s warrant activity and related information for the years ended December 31 are shown below.
Outstanding • beginning of year
Granted
Exercised
Forfeited
Expired
Outstanding • end of year
Exercisable at end of year
Weighted average fair value of warrants granted during the year:
2010
15,418,178
1,200,000
(40,000)
•
(7,516,104)
9,062,074
8,762,074
0.55 $
Warrants
2009
10,634,848
6,328,330
(250,000)
•
(1,295,000)
15,418,178
15,418,178
1.61 $
$
F-17
Weighted Average
Exercise Price
2008
2010 2009 2008
13,031,515 $ 1.50 $ 1.40 $ 1.87
• 1.80 1.61
•
(951,665) 0.26 1.16 0.97
•
•
(1,445,002) 2.04 1.28 2.60
10,634,848 1.47 1.50 1.40
10,634,848 $ 1.50 $ 1.50 $ 1.40
•
•
•
The following table summarizes additional information concerning warrants outstanding and exercisable at December 31, 2010:
Range of Exercise Prices
0.26 • 1.00
1.01 • 2.00
2.01 • 3.00
3.01 • 3.50
$
$
$
$
15. ALSCRT Amendment
Number of
Shares
1,320,000
7,257,493
324,581
160,000
9,062,074
Warrants Outstanding
Weighted
Average
Remaining
Contractual Life
(years)
Weighted
Average
Exercise Price
Warrants
Number of
Shares
Exercisable
Exercisable
Weighted Average
Exercise Price
3.75 $
2.65
4.83
4.86
2.93 $
0.49
1.55
2.75
3.50
1.47
1,020,000 $
7,257,396
324,678
160,000
8,762,074 $
0.40
1.55
2.75
3.50
1.50
Pursuant to an amendment signed between the Company and the beneficiary of the ALSCRT on August 6, 2009, the Company was released from all
restrictions on the use of any proceeds previously paid to the Company in connection with the arrangement. As a result, the Company recognized $6.7 million
as service revenue in the third quarter of 2009, which represented the remaining deferred revenue and previously un-recognized portion of the value received.
16. 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”).
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.
17. Income Taxes
At December 31, 2010, the Company had federal and state net operating loss carryforwards of $100.3 million and $79.4 million, respectively, available
to offset against future taxable income, which expire in 2011 through 2030. As a result of a change in-control that occurred in the CytRx shareholder base in
July 2002, approximately $13.7 million in federal net operating loss carryforwards became limited in their availability to $363,000 annually. Management
currently believes that the remaining $86.6 million in federal net operating loss carryforwards, and the $65.7 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. As of December 31, 2010, CytRx also had research and development and alternative minimum tax credits for
federal and state purposes of approximately $4.8 million and $5.2 million, respectively, available for offset against future income taxes, which expire in 2022
through 2030. 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.
F-18
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):
Deferred tax assets:
December 31,
2010 2009
Net operating loss carryforwards
Tax credit carryforwards
Equipment, furnishings and other
$ 38,715 $ 35,285
8,957
8,142
8,663
8,554
Total deferred tax assets
Deferred tax liabilities
Net deferred tax assets
Valuation allowance
(830)
55,932 52,384
(560)
55,102 51,824
(55,102) (51,824)
•
• $
$
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, 2010 and 2009 was $3.3 million and $3.7 million, respectively.
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):
Federal benefit at statutory rate
State income taxes, net of Federal taxes
Permanent differences
Book gain in excess of tax gain
Provision related to change in valuation allowance
Net change in research and development tax credits
Other, net
Years ended December 31,
2010 2009 2008
139 $ (1,809) $ (8,899)
$
(310) (1,525)
24
(136) 16,272
22
(3,630)
•
3,278 3,651 (5,073)
• (2,826) (2,207)
911 (2,304)
872
0 $ (519) $
167
•
$
There have been no changes to the Company’s liability for unrecognized tax benefits during the year ended December 31, 2010.
The Company and its Subsidiaries file income tax returns in the U.S. Federal jurisdiction and various state jurisdictions. As of the date of adoption of
ASC 740 and the year ended December 31, 2010, the tax returns for 2008 through 2010 remain open to examination by the Internal Revenue Service and
various state tax authorities.
The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the
date of adoption of ASC 740 and the years ended December 31, 2010, 2009 and 2008, the Company had accrued no interest or penalties related to uncertain
tax positions.
18. Quarterly Financial Data (unaudited)
Summarized quarterly financial data for 2010 and 2009 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)
2010
Total revenues
Net income (loss)
Net income (loss) applicable to common stockholders
$
Basic and diluted loss per share applicable to common stock $
2009
Total revenues
Net income (loss)
Net income (loss) applicable to common stockholders
$
Basic and diluted loss per share applicable to common stock $
$
$
• $
• $
(611) 1,294
(611) $ 1,294 $
0.01 $
(0.01) $
1,483 $ 1,000 $
(3,973) (2,226)
(3,973) $ (2,226) $
(0.04) $ (0.02) $
• $
(4,414)
(4,414) $
(0.04) $
6,954 $
3,863
3,863 $
0.04 $
100
4,140
4,140
0.04
100
(2,983)
(2,983)
(0.03)
F-19
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.
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 a deemed dividend of $757,000. That deemed dividend is 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.
19. 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. Because Innovive was a development stage company, under accounting principles generally accepted in the United States and the SEC
regulations, it was not considered a business. Accordingly, CytRx accounted for the merger in accordance with ASC 350 (previously Statement of Financial
Accounting Standards No. 142, Goodwill and Other Intangible Assets), for transactions other than a business combination. 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 reflect these fair values and were not
restated retroactively to reflect the historical financial position or results of operations of Innovive. In connection with the merger, the Company recorded a
one-time expense for acquired in-process research and development. Under the merger agreement by which the Company acquired Innovive, it agreed to pay
the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to the Company’s achievement
of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of CytRx common stock,
subject to specified conditions, or, at the Company’s election, in cash or by a combination of shares of CytRx common stock and cash. The Company’s
common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of its common stock at the time the
earnout merger consideration is paid.
20. Subsequent Events
On February 11, 2011, ADVENTRX Pharmaceuticals, Inc. entered into a definitive agreement for the acquisition of SynthRx, Inc., in which the
Company holds a 19.1% interest. Upon the closing of the transaction, the Company will receive approximately 191,000 shares of common stock of
ADVENTRX, and if all milestones under the agreement are achieved, CytRx would receive up to 2.9 million additional shares, in the aggregate representing
an approximate 7.8% ownership stake in ADVENTRX. The last sale price of ADVENTRX shares on the NYSE Amex on March 9, 2011 was $2.06. The
merger is subject to customary closing conditions. When issued at the closing, the ADVENTRX shares issued to the Company will be subject to certain
transfer and voting restrictions under a Stockholders' Voting and Transfer Restriction Agreement.
F-20
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 (“the Company”) as of December 31, 2010 and 2009 and the related
consolidated statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2010. 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 and schedule 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, 2010 and 2009, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2010, in
conformity with accounting principles generally accepted in the United States of America.
Also, in our opinion, the financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, present
fairly, in all material respects, the information set forth therein.
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, 2009, 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, 2011 expressed an unqualified opinion thereon.
/s/ BDO USA, LLP
Los Angeles, California
March 11, 2011
F-21
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
CytRx Corporation
Los Angeles, California
We have audited CytRx Corporation’s (“the Company”) internal control over financial reporting as of December 31, 2010, 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, 2010, 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 sheets of the
Company as of December 31, 2010 and 2009, and the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the
period ended December 31, 2010 and our report dated March 11, 2011 expressed an unqualified opinion thereon.
/s/ BDO USA, LLP
Los Angeles, California
March 11, 2011
F-22
CYTRX CORPORATION
SCHEDULE II • VALUATION AND QUALIFYING ACCOUNTS
For the Years Ended December 31, 2010, 2009 and 2008
Additions
Description
Reserve Deducted in the Balance Sheet from the Asset to Which it
Balance at
Beginning of Year
Charged to
Costs and Expenses
Charged to
Other Accounts
Deductions
Balance at
End of Year
Applies:
Allowance for Deferred Tax Assets
Year ended December 31, 2010
Year ended December 31, 2009
Year ended December 31, 2008
$
$
$
51,824,000 $
48,998,000 $
53,246,000 $
• $
• $
• $
3,278,000 $
2,826,000 $
• $ 55,102,000
• $ 51,824,000
• $ 4,248,000 $ 48,998,000
F-23
AGREEMENT FOR CLINICAL SERVICES
EXHIBIT 10.24
THIS AGREEMENT, dated as of the Sixth day of December 2010, is by and among CytRx Corporation, (“CytRx ” or “SPONSOR”), with offices located at
11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and Oncotherapeutics (“Oncotherapeutics” or “CRO”), with offices located at 9201
Sunset Boulevard, Suite 317, West Hollywood, CA 90069.
WHEREAS, CytRx Corporation, a corporation organized and existing under the laws of the State of Delaware, is engaged in the discovery,
development and marketing of pharmaceutical products; and
WHEREAS, Oncotherapeutics, a corporation organized and existing under the laws of the State of California is a contract research organization
engaged in the business of managing and monitoring clinical trials and analyzing clinical research data for pharmaceutical products; and
WHEREAS, CRO desires to assist SPONSOR in organizing, monitoring and supervising certain clinical research activities set forth herein and
SPONSOR desires to retain CRO upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and mutual promises and undertakings herein contained, the parties hereto agree as follows:
1.
DEFINITIONS
The following terms as used in this Agreement shall have the meaning set forth hereinafter:
1.1 “CRO" means contract research organization as described in 21 C.F.R. § 312.3 of the FDA regulations.
1.2 “Direct Expenses” means personnel expenses, including any and all overhead or internal costs, as a result of performing the Services
herein.
1.3 "FDA" means the United States Food and Drug Administration or any successor agency thereto.
1.4 "Investigator" means any person conducting studies in humans in connection with the Study, or any other person acting under the
direction, control or authority of such person with respect to a Study involving a Study Drug supplied by SPONSOR.
1.5 “Pass-through Expenses” means out-of-pocket expenses in connection with the performance of Services provided hereunder, such as travel fees
(coach and not first-class air travel), Investigator fees, Investigator site start-up fees, printing fees, shipping/mailing fees and fees related to the storage,
labeling and shipment of the Study Drugs.
1.6 "Protocol" means the Protocol entitled "A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and
Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects with Advanced Non-Small Cell Lung Cancer” attached
hereto as Exhibit A.
1.7 "Services" mean the services to be performed by CRO and obligations undertaken by CRO as outlined in this Agreement and in Exhibits
A and B, attached hereto and made a part hereof.
1.8 "Study" means the multicenter clinical study to be conducted in accordance with the Protocol.
1.9 "Study Drugs" means those substances referred to in the Protocol.
2. SERVICES
2.1 CRO shall provide the Services in accordance with the terms hereof. Any changes made to the Protocol must be approved in advance in
writing by SPONSOR and must receive the necessary Institutional Review Board (“IRB”) approval and, if required by 21 C.F.R. § 312.30, be submitted to the
FDA prior to implementation. In the event of revision of the Protocol or an Exhibit hereto, the most recent version or revision thereof shall govern. CRO shall
comply with the Protocol, all applicable federal, state and local laws, rules and regulations including, without limitation, the rules and regulations promulgated
by FDA, with respect to the Services performed by CRO hereunder, including, but not limited to, the requirements of 21 C.F.R. Part 312, Good Clinical
Practices, including but not limited to the Drug and Cosmetic Act, 1940 and the regulations promulgated pursuant thereto, and with the standard of care
customary in the contract research organization industry. In the event of any actual or perceived noncompliance with the Protocol, or with applicable federal,
state, or local laws, rules, or regulations that may affect the integrity of Study data, CRO shall notify SPONSOR immediately.
2.2.1 CRO shall use its best endeavors to deliver the maximum enrollment to SPONSOR of no less than 140 enrolled patients.
2.2.2 CRO shall use its best endeavors to deliver to SPONSOR no less than TWELVE sites within the United States for this study and will work with the
THREE sites in Mexico City, Mexico that have been identified by the SPONSOR for this study.
2.3 CRO shall also provide additional Services specified in any future additions or modifications, which may be agreed to among all of the
parties and shall be incorporated in writing as amendments of the relevant Exhibit hereto. If SPONSOR wishes to change the scope of the Services or wishes
to obtain additional Services not initially covered by this Agreement and/or not listed in an Exhibit hereto, SPONSOR shall so advise CRO and submit
requirements and specifications to CRO. After receipt of the requirements and specifications, CRO shall provide SPONSOR with a reasonable cost estimate
for performing the modified or additional Services. No such cost estimate shall be the basis for a change in the fees payable to CRO unless and until it has
been agreed to and approved in writing by SPONSOR. In the event there is no agreement among the parties with respect to such additional costs, the parties
agree to resolve any differences as provided in Section 4.1 below. Any such modified or additional Services provided by the CRO thereby shall be governed
by the terms and conditions of this Agreement and by such supplementary written amendments of this Agreement or Exhibits to this Agreement as may be
executed among the parties from time to time. In the event of a conflict between the terms of this Agreement and an Exhibit, the terms of this Agreement shall
govern.
2.4 CRO shall designate in writing one individual who will act as agent for CRO and will have the authority and responsibility to act on
behalf of CRO in connection with all obligations undertaken by CRO in this Agreement. SPONSOR shall designate in writing one individual who will act as
agent for SPONSOR and will have the authority and responsibility
to act on behalf of SPONSOR in connection with all obligations undertaken by SPONSOR in this Agreement. Such designations may be modified from time
to time and shall be in writing and communicated to all other parties.
3. TERM
3.1 This Agreement shall be effective upon the date first set forth above and shall
thereafter remain in full force and effect until completion of all Services contemplated
hereunder or termination of this Agreement as provided for in Section 6 below. CRO shall
use its best efforts to complete the Services within THIRTY SIX months after the date first set forth above.
4.
COMPENSATION AND EXPENSES
4.1 As compensation for the Services performed hereunder SPONSOR shall pay CRO the amounts specified in Exhibit B attached hereto and
made a part hereof in accordance with the payment schedule set forth therein. The total amount of Direct Expenses payable by SPONSOR to CRO for
Services rendered by CRO hereunder shall in no event exceed the total amount of FIVE MILLION EIGHT HUNDRED AND FIFTY TWO THOUSAND
TWO HUNDRED AND EIGHTY EIGHT DOLLARS AND FORTY CENTS ($5,852,288.40) without SPONSOR'S prior written approval in the form of a
purchase order amendment. The total amount set forth above, or any agreed-upon adjustment, shall be inclusive of any and all overhead or internal costs of
CRO. All work to be undertaken pursuant to this Agreement shall not commence until a preauthorized purchase order is in place between SPONSOR and
CRO.
4.2 SPONSOR will reimburse CRO for all reasonable Pass-through Expenses actually incurred by CRO in connection with the performance of Services
provided hereunder. SPONSOR will reimburse CRO for all such Pass-through Expenses, within thirty (30) days of receipt by SPONSOR of periodic itemized
statements covering such expenses. Such expense statements will be accompanied by an invoice and such invoice shall be itemized in reasonable detail and
shall include reasonable documentation (including all receipts associated with travel, lodging, food, etc.) in support of such expenses and invoice. The total
amount payable by SPONSOR to CRO for such Pass-through Expenses shall in no event exceed the total amount of ONE MILLION AND FORTY SIX
THOUSAND NINE HUNDRED AND EIGHTY ONE DOLLARS AND SIXTY SEVEN CENTS ($1,046,981.67), unless an increase in such amount is
authorized in writing by SPONSOR in the form of a purchase order amendment.
4.3 If the scope of the Services or the time necessary to complete the Study change and such changes are beyond the reasonable control of
CRO, the fees and expenses to SPONSOR pursuant to such Exhibit will be adjusted as mutually agreed upon in writing by SPONSOR and CRO in the form
of a purchase order amendment. In the event of disagreement with respect to such changes and/or fees and expenses to be paid therefor, the Study will
proceed and CRO will continue rendering its Services while the disagreement is being resolved. Resolution of such disputes shall be accomplished by good
faith negotiations by a senior officer of each party within thirty (30) days of notice furnished in accordance with Section 12 hereunder. If necessary, thereafter,
resolution of such disputes shall be accomplished at the written request of any party hereto to the other parties by binding arbitration, which shall not interfere
with the timely rendering of CRO's Services, pursuant to the Rules of Conciliation and Arbitration of the American Arbitration Association, using a three-
person panel of arbitrators selected by mutual agreement of the parties.
4.4 Unless otherwise specified in any Exhibits that now or hereafter may be agreed to among the parties, upon SPONSOR's request CRO
shall be responsible for negotiating Investigator fees with each Investigator at each Study site participating in the Study. Such fees as well as pass-through
expenses pursuant to Section 4.2 hereof shall be paid in advance from time to time by SPONSOR into a separate bank account in the name of CRO. CRO
shall transmit copies of such bank account statements together with a schedule of all payments from such account to SPONSOR quarterly. CRO shall direct
such fees, when earned in accordance with the Clinical Research Agreement entered into among SPONSOR, CRO, the Investigator(s) and/or CRO, to be paid
to the Investigators and/or institutions in which the Study is being conducted as the case may be. Any interest earned on said bank account funds shall remain
in the fund and belong to SPONSOR. In the event the funds advanced by SPONSOR pursuant to this Section 4.4 are insufficient to cover the payment of fees
and expenses to the Investigators, upon written notice from CRO, SPONSOR will promptly deposit into such bank account the additional amounts required.
SPONSOR reserves the right to make all such pass-through payments under Sections 4.2 and 4.4 hereof directly to the Investigators, institutions and/or other
third parties and the relevant Exhibit shall so provide. Clinical Research Agreements required for an Investigator at any Study site shall be among SPONSOR,
CRO and the Investigator and/or institution and the form and content of such agreement shall be prepared and furnished to CRO by SPONSOR.
4.5 In order to enable SPONSOR to comply with applicable federal tax laws and regulations, CRO agrees to provide, if requested by
SPONSOR, within forty-five (45) days after the close of each calendar year, the total amount of funds which CRO and/or the Investigators received from
SPONSOR relating to research activities during the year and any other information related to this Agreement which SPONSOR reasonably requires to
properly compute their respective tax liabilities.
4.6 In consideration of its performance of Services hereunder, SPONSOR shall pay CRO the fees and expenses set forth in Exhibit B which
is attached hereto and made a part hereof. The budget estimates contained in Exhibit B represent CRO's best estimate of the costs to perform all Services to
be provided hereunder by CRO. In the event that actual and accrued expenses indicated as Direct and "Pass-through Costs" in Exhibit B which are incurred by
CRO at the conclusion of the Study are less than the amounts paid by SPONSOR for such expenses, CRO will promptly refund to SPONSOR any excess
amount paid at the conclusion of the Study.
5.
CONFIDENTIAL INFORMATION
5.1 “Confidential Information” means all secret, trade secret, privileged, confidential or proprietary written information and data provided by
SPONSOR to CRO pursuant to this Agreement, or generated or developed by CRO or Investigator pursuant to this Agreement, or any such secret, trade
secret, privileged, confidential or proprietary information disclosed orally, which is reduced to writing within thirty days of oral disclosure and identified as
being "confidential," except any portion thereof which:
(1) was lawfully in the possession of CRO and known to it without restriction as to its use prior to disclosure by SPONSOR, to the
extent such possession and knowledge is documented; or
(2) was in the public domain or the subject of public knowledge at the time of disclosure by SPONSOR; or
(3) becomes part of the public domain or the subject of public knowledge through no breach of this Agreement by CRO, or
(4) becomes available to CRO from a third party other than in breach of a legal obligation of confidentiality to SPONSOR in
respect thereof; or
(5) is independently generated by CRO without reference to or use of the Confidential Information received hereunder; or
(6) is required by law, administrative or judicial order to be disclosed. CRO shall notify SPONSOR as soon as possible, but in no
event later than two days after learning of an attempt to have information disclosed pursuant to a legal, administrative or judicial order, in
order that SPONSOR shall have the opportunity to challenge the order prior to disclosure.
5.2 Except as required by applicable law, for the term of this Agreement and for ten years thereafter, CRO shall not use or disclose to any
party SPONSOR’S Confidential Information received pursuant to this Agreement or otherwise, without the prior written consent of SPONSOR.
5.3 Notwithstanding the preceding section, CRO may, without SPONSOR’S prior written consent:
(1) use SPONSOR’S Confidential Information solely for the purposes of performing its obligations under this Agreement, and
(2) disclose SPONSOR’S Confidential Information to the minimum number of its (a) officers, employees, consultants or agents
whose work requires use of such Confidential Information; (b) investigators or other authorized persons engaged in carrying out the
Study; or (c) third party independent contractors referenced in any Exhibit to this Agreement who are under a written obligation to
maintain the confidentiality of such Confidential Information to the same extent as CRO.
CRO shall ensure that all of its officers, employees, consultants, agents, investigators or contractors who receive such Confidential
Information understand and shall be bound by the confidentiality provisions of this Agreement. In addition, CRO shall routinely identify SPONSOR’S
Confidential Information in such manner to preserve its confidential status.
5.4 Unless otherwise agreed in writing, within thirty days after the termination of the Agreement or the written request by SPONSOR, CRO
shall return to SPONSOR all of SPONSOR’S Confidential Information in documentary or permanent form including any and all copies thereof.
5.5 CRO agrees that SPONSOR is and shall remain the exclusive owner of its Confidential Information and all patent, copyright, trade secret
and other intellectual property rights therein unless and until a further agreement is executed.
5.6 CRO and SPONSOR acknowledge that any violation of the terms of this Section 5 may result in irreparable injury and damage to
SPONSOR that is not adequately compensable in money damages, and for which SPONSOR will have no adequate remedy at law. CRO therefore consents
and agrees that SPONSOR may obtain injunctions, orders or decrees as may be necessary to protect the Confidential Information, without the necessity of
proving actual damages, in addition to any other remedies which SPONSOR may have in law or equity.
5.7 CRO acknowledges that during the performance of this Agreement it may come into possession of certain material information about
SPONSOR or its affiliates that has not yet been disclosed to the public. CRO agrees to comply with the rules and regulations of the United States Securities
and Exchange Commission ("SEC"), including those relating to insider trading for as long as CRO is in the possession of such material, non-public,
information about SPONSOR or its affiliates. CRO is hereby notified that it should not trade in SPONSOR securities on its own behalf or on the behalf of
others while in possession of any such material, non-public information.
5.8 These confidentiality requirements shall survive the termination of this Agreement.
6. TERMINATION
6.1 This Agreement may be terminated by SPONSOR or suspended by SPONSOR at any time with or without cause by giving CRO at least
thirty (30) days' prior written notice thereof. As soon as practicable after CRO's receipt of, and consistent with, such notice, CRO shall upon SPONSOR'S
request suspend all activities and/or instruct the Investigators immediately to discontinue further acquisition, screening or entry of patients into the Study and
distribution (including dispensing or administration) of Study Drugs. During the thirty (30) day period between the notice of suspension or termination and the
effective date of such suspension or termination, CRO shall use its best efforts to conclude and/or, upon SPONSOR’s request, transfer the responsibility for
such Study to SPONSOR or SPONSOR’s designee. Such action shall be performed by CRO, as soon thereafter as practicable in accordance with its
responsibilities under this Agreement and applicable law and regulation, in order to reduce or eliminate further costs and to cancel, to the extent reasonably
possible, any third party obligations. Within thirty (30) days after the effective date of suspension or termination of this Agreement, CRO shall transmit to
SPONSOR all case reports and other data and information collected or prepared by CRO prior to the effective date of suspension or termination and
coordinate the return of all unused Study Drugs to the SPONSOR. In addition, CRO shall provide SPONSOR with a written itemized statement of all work
performed by CRO in connection with the suspended or terminated Agreement. Such statement shall include only those Services detailed in Exhibit A hereto
and shall be based upon the payment schedule set forth in Exhibit B hereto, as such Exhibits may be amended from time to time by the parties hereto.
6.2 In the event of suspension or termination of this Agreement pursuant to Section 6.1 or Section 6.4 hereof, CRO shall be entitled to a
partial payment based on the pro rata portion of Services provided by it in connection with this Study as set forth in Exhibit B through the effective date of
suspension or termination as calculated jointly by the parties. If amounts already paid by SPONSOR to CRO in connection with the Study exceed such pro
rata calculation, then CRO shall refund such excess to SPONSOR. If such pro rata calculation exceeds the amount already paid by SPONSOR to CRO in
connection with the Study, then SPONSOR shall pay the balance due to CRO. Any refund or payment under this Article 6 shall be made within thirty (30)
days after SPONSOR's receipt and approval of CRO's itemized statement.
6.3 This Agreement may be terminated by CRO or SPONSOR upon any material default in performance by the other party, provided that any
defaulting party shall be given not less than thirty (30) days' prior written notice of default and the opportunity to cure the default during such period.
SPONSOR shall also be authorized to terminate this Agreement in the event CRO is in default under any related Study involving the Master Protocol.
6.4 This Agreement may be terminated or suspended immediately by SPONSOR if the FDA halts the Study or requests that the Study be
suspended, or if any of the conditions for termination set forth in Section 18 apply.
6.5 If not sooner terminated, this Agreement will expire five (5) years from the date hereof or one (1) year after the completion of the
Services contemplated by all Exhibits hereto, whichever is later.
7. INDEMNIFICATION
7.1 SPONSOR agrees to assume responsibility and liability for and agrees to indemnify and hold harmless CRO (hereinafter “CRO
Indemnitees”) from and against any and all costs (including reasonable attorney's fees), damages, expenses, losses, suits, claims and demands, in any manner
caused by, resulting from or arising out of proper adherence to this Agreement, and any applicable federal, state and local laws and regulations, excepting
damage or injury which may be attributed to the failure of the CRO Indemnitees to adhere to the Agreement, or any applicable federal, state and local laws
and regulations, or which may be attributable to the negligence or willful misconduct of the CRO Indemnitees.
7.2 CRO agrees to defend, indemnify and hold harmless SPONSOR and SPONSOR’s officers, employees, consultants or agents (hereinafter
“SPONSOR Indemnitees”) from and against any and all costs (including reasonable attorneys' fees), damages, expenses, losses, suits, claims and demands, in
any manner caused by, resulting from or arising out of any act, omission, misrepresentation, negligence or breach of this Agreement on the part of CRO and
its respective agents, including, without limiting the foregoing, any damage or injury arising out of the failure of CRO employees, directors, independent
contractors and agents to adhere to the Agreement, or any applicable federal, state and local laws and regulations, or which may be attributable to the
negligence or willful misconduct of CRO employees, directors, independent contractors and agents or CRO’s officers, employees, consultants or agents.
7.3 In the event that either party seeks indemnification under the terms of this provision or any other provision, it shall inform the other party
of the claim as soon as reasonably practicable after it receives notice of the claim, shall permit the other party to assume direction and control of the defense of
the claim (including the right to settle the claim solely for monetary consideration), and shall cooperate as requested (at the expense of the other party), in the
defense of the claim.
7.4 These provisions regarding indemnifications shall survive the termination of this Agreement.
7.5 Neither party hereto shall have any liability to the other for any indirect or consequential losses or damage suffered by the other (whether
in contract, tort or otherwise) whensoever, wheresoever or howsoever arising, except to the extent caused by such party’s gross negligence or willful
misconduct. A party’s liability to the other is in no way limited to the extent of the party’s insurance coverage. This provision shall survive the termination of
this Agreement.
8. PUBLICITY
8.1 CRO shall not disclose, except as required by law or as required to fulfill regulatory obligations of the FDA, the existence of this
Agreement nor use or publish the name of SPONSOR hereto in promotion, advertising or for any other purpose without the prior written consent of
SPONSOR. CRO also will not make any public presentations about the Study Drug or the Study or issue any news releases about the Study Drug or Study.
9. PUBLICATIONS AND REGISTRATION
9.1 At the conclusion of the Study, SPONSOR intends to publish a paper which presents all of the data collected at all sites participating in
the Study. CRO agrees that it will not publish or otherwise present papers relating to the Study or which disclose data collected in the Study.
9.2 SPONSOR shall bear the exclusive right and responsibility to submit Study-related information to clinical trial registry and results
databases. CRO shall forward any related inquiries or information to SPONSOR to be addressed by SPONSOR or SPONSOR’s delegate.
10. INDEPENDENT CONTRACTOR
10.1 CRO shall perform Services under this Agreement only as an independent contractor and nothing contained herein shall be construed to
be inconsistent with that relationship or status. CRO, its employees, and consultants shall not be considered employees or agents of SPONSOR. This
Agreement shall not constitute, create, or in any way be interpreted as, a joint venture, partnership, or business organization of any kind between CRO and
SPONSOR. No party hereto shall have the authority to bind any other party hereto to any agreement whatsoever.
11. PATENT RIGHTS AND DATA OWNERSHIP
11.1 CRO will disclose promptly in writing to SPONSOR or its respective designees any and all inventions, discoveries and improvements,
whether or not patentable, conceived or made by CRO while providing Services to SPONSOR pursuant to the Agreement which relate to the Study or the
Study Drug(s) or, once CRO becomes aware of the same, conceived or made by any Investigator arising out of his or her participation in the Study. Any
intellectual property rights associated with such inventions, discoveries, or improvements shall be the sole and exclusive property of SPONSOR and CRO
agrees on its own behalf and on behalf of its employees to assign all its rights, title and interest therein to SPONSOR. CRO will execute any and all patent
applications, assignments, or other instruments and give any testimony which SPONSOR reasonably deems necessary to apply for and obtain patents covering
such inventions,
discoveries or improvements (the "Activities"). SPONSOR shall compensate CRO for the time devoted to such Activities and reimburse it for the reasonable
expenses incurred in connection therewith. These obligations shall continue beyond the termination of this Agreement with respect to inventions, discoveries
and improvements conceived or made by CRO while providing Services to SPONSOR pursuant to this Agreement which relate to the Study or the Study
Drug(s), or by any Investigator arising out of his or her participation in the Study, and shall be binding upon their respective assigns, administrators and other
legal representatives. CRO agrees that all Clinical Research Agreements with Investigators and/or institutions shall include such obligations concerning
assignment of inventions to SPONSOR.
11.2 All data generated or arising from the performance of this Agreement shall be the exclusive property of SPONSOR.
12. COMMUNICATIONS AND PAYMENTS
12.1 Original Study documents and other original documents required under this Agreement shall be sent by mail or delivery service requiring
the signature of the addressee and addressed to the respective parties at the addresses set forth in Section 12.3 below.
12.2 All legal notices shall be in writing and sent by certified mail, return receipt requested, to the respective parties at their addresses set
forth in Section 12.3 below. Such notices shall be effective upon receipt.
12.3 All other notices and other communications and payments provided for in this Agreement shall be given personally or by first class mail
or by a nationally-recognized overnight courier service, postage prepaid, or by facsimile (and promptly confirmed by such mail or courier service), addressed
to the respective parties as follows:
To CRO: Oncotherapeutics
9201 Sunset Boulevard, Suite 317
West Hollywood, CA 90069
Phone: (310) 623-1200
Fax: (310) 623-1121
Attn: Geoffrey M. Gee, Esq.
To SPONSOR: CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Attn: Carrie Nodgaard
All invoices should be sent to Attention: Accounts Payable
13. ASSIGNMENT
13.1 Unless otherwise provided in an Exhibit to this Agreement, CRO agrees that it will not engage the services of third parties to perform any of the
Services hereunder and will not subcontract any of the Services it is obligated to perform pursuant to this Agreement to any third party without the prior
express written consent of SPONSOR. CRO shall be permitted to use consultant personnel to conduct site inspection/monitoring visits to the sites only with
SPONSOR’s prior written consent. Additionally, CRO may not assign this Agreement to any third party without the prior express written consent of
SPONSOR.
14. DRUG SUPPLIES
14.1 Study Drug(s) shall be shipped by SPONSOR to a CRO subcontractor engaged in the business of drug storage, shipping and handling
designated by CRO and reasonably acceptable to SPONSOR for delivery to Investigators. SPONSOR represents and warrants that all necessary approvals
and/or regulatory filings under the United States Food, Drug and Cosmetic Act, the regulations promulgated thereunder and other federal, state, or regulatory
laws or approvals shall be obtained and/or made in connection with the shipment of such Study Drug(s).
14.2 At the completion of the Study, CRO shall request that each site provides SPONSOR with a written accounting of all Study Drug(s)
used at their site in the Study. CRO shall request that each site return all unused Study Drug to SPONSOR or its designee. During the Study, CRO shall
instruct the Investigators to maintain records of the dates and amounts of Study Drug(s) received at each Study site; the dates, amounts and patients to whom
the Study Drug(s) have been dispensed or administered; the dates and amount of Study Drug(s) disposed of, damaged or lost; and the dates and amounts of
Study Drug(s) being returned and CRO shall monitor the Investigators' compliance with such instruction.
15. TRANSFER OF OBLIGATIONS
15.1 With regard to the Services performed hereunder, CRO shall be responsible for the obligations transferred by SPONSOR to CRO in
CRO's role as the designated contract research organization for such Study and as described in Exhibit B attached hereto and made a part hereof. This section
shall be construed as a transfer of those obligations described in Exhibit B attached hereto and made a part hereof under FDA regulations 21 C.F.R. Part 312
and CRO shall perform those obligations pursuant to 21 C.F.R. Part 312.
16. INSPECTIONS AND COOPERATION
16.1 CRO shall from time to time, during the conduct of the Study and upon at least ten (10) business days’ prior written notice to CRO,
assist representatives of SPONSOR when requested by SPONSOR in examining the records, standard operating procedures, and facilities of the Investigators,
validating case reports against original data in the Investigators' or hospital records or applicable files, and monitoring the Services performed hereunder, at
reasonable times and in a reasonable manner, to determine the adequacy of the Investigator's facilities and whether the Study is being conducted in
compliance with the Protocol and applicable regulations. Upon notice from CRO, FDA, or an IRB of any noncompliance with the Protocol or applicable law,
CRO shall permit representatives of SPONSOR to review records related to the services performed hereunder as soon as possible. Notwithstanding the
existence of SPONSOR's rights under this Section 16.1, SPONSOR shall be under no obligation to exercise these rights.
16.2 CRO will permit representatives of SPONSOR, upon at least ten (10) business days' prior written notice to CRO, to examine, at
reasonable times and in a reasonable manner, the standard operating procedures and facilities of CRO and such records which SPONSOR may reasonably
require in order to determine whether the Study is being conducted in compliance with the Protocol and FDA regulations. Notwithstanding the existence of
SPONSOR’S rights under this Section 16.2, SPONSOR shall be under no obligation to exercise these rights.
16.3 If the FDA, any other federal, state or local government authority, or an IRB conducts, or gives notice to any party hereto of its intent to
conduct an inspection at any investigational site or takes any other regulatory action with respect to any Study conducted under this Agreement, then the party
so notified shall immediately give the other parties hereto notice thereof, and each party shall provide the other parties with any information reasonably
required in connection therewith.
16.4 CRO shall promptly notify SPONSOR of any violation or deficiency noted by FDA or any regulatory agency related to the services
performed by CRO under this Agreement. CRO will release any records required to be made available to the inspecting or inquiring authority by law or
regulation, but will not release any Confidential Information not required by law to be provided for inspection or copying without specific written consent of
SPONSOR.
16.5 CRO shall provide SPONSOR with a written report of any inspection related to the Study, noting with specificity each Study-related
record or document reviewed by or supplied to the regulatory inspector. CRO shall maintain copies of Study-related records or documents supplied to an
inspector in a separate inspection file and, upon request by SPONSOR, shall provide copies of any such records or documents to SPONSOR. CRO shall
provide SPONSOR with a copy of all correspondence between CRO and a regulatory authority relating to activities undertaken pursuant to this Agreement,
purged only of confidential information that is unrelated to the activities under this Agreement. CRO shall provide SPONSOR with a copy of any proposed
response to a regulatory authority relating to activities under this Agreement for SPONSOR’s prior review.
16.6 CRO shall permit an independent public accounting firm designated by SPONSOR to have reasonable access upon at least ten (10)
business days’ prior written notice to CRO and during normal business hours to CRO's financial books and records as may be reasonably necessary to verify
all out-of-pocket costs and pass through expenses incurred by CRO during performance of Services set forth in this Agreement. SPONSOR agrees that it will
not use such information other than for the purposes of this Agreement and that it shall maintain all such information so obtained in strict confidence.
17. WARRANTIES, REPRESENTATIONS AND DISCLAIMER
17.1 CRO warrants and represents to SPONSOR that CRO has the capability to fulfill in accordance with generally accepted professional standards the
services, which it will perform under this Agreement.
17.2 CRO warrants and represents to SPONSOR that CRO shall perform its obligations under this Agreement in accordance with the terms
and conditions set forth herein.
17.3 CRO represents and warrants that it has obtained and will maintain for the term of the Agreement, all licenses, authorizations, approvals
and reviews required by any federal, state or local governmental authority for performance of any activities under this Agreement.
17.4 SPONSOR acknowledges that the results of the services to be provided hereunder are inherently uncertain and that, accordingly, there
can be no assurance, representation, or warranty by CRO that any Study Drug covered by this Agreement can, either during the term of this Agreement or
thereafter, be successfully developed or, if so developed, will receive the required approval by the FDA.
17.5 SPONSOR acknowledges that CRO will provide professional services hereunder and not a product.
18. DEBARMENT
18.1 CRO hereby certifies that neither CRO nor any of CRO’s officers, employees, consultants, or agents providing services to SPONSOR
has been debarred, nor have they been engaged in any acts which could be considered for debarment, under the provisions of the Generic Drug Enforcement
Act of 1992, 21 U.S.C. § 335(a) and (b). In the event that CRO, any of CRO’s officers, employees, consultants, or agents providing services to SPONSOR or
any Investigator (i) becomes debarred or (ii) receives notice of action or threat of action with respect to its debarment during the term of the Agreement, CRO
agrees to notify SPONSOR immediately. In the event that CRO, any of CRO’s officers, employees, consultants, or agents providing services to SPONSOR or
any Investigator becomes debarred as set forth above, this Agreement shall automatically terminate upon receipt of such notice without any further action or
notice. In the event that CRO, any of CRO’s officers, employees, consultants, or agents providing services to SPONSOR or any Investigator receives notice of
action as set forth in clause (ii) above, CRO understands that SPONSOR shall have the right to terminate this Agreement immediately pursuant to the
provisions of Section 6 hereof.
18.2 CRO hereby certifies that it has not and will not use in any capacity in connection with this Agreement the services of any individual,
corporation, partnership or association which has been debarred under 21 U.S.C. § 335(a) or (b). In the event that CRO receives notice of the debarment or
threatened debarment of any individual, corporation, partnership or association providing services to CRO, which relate to CRO's activities under this
Agreement, CRO shall notify SPONSOR immediately. CRO understands that SPONSOR shall have the right to terminate this Agreement immediately upon
receipt of such notice pursuant to the provisions of Section 6 hereof.
19. ADVERSE EXPERIENCE REPORTING AND RECORDKEEPING
19.1 CRO shall notify SPONSOR immediately, but in no case more than twenty-four hours, by telephone or facsimile, upon learning of the
occurrence during the Study of any Serious or Unexpected Adverse Experience, as defined at 21 C.F.R. § 312.32(a), and any event which may reasonably be
believed to impair the integrity or validity of the Study. Any notification made by telephone shall be confirmed in writing within two days.
19.2 CRO shall maintain all records required to be maintained under federal, state or local laws, including, but not limited to, case report
forms, drug study and reconciliation documentation and the site study file, which should include all Study-related correspondence. CRO shall ensure that all
Investigators sign statements in each patient’s/subject’s case report form attesting to Investigator’s review of the data, and attesting that the data are an
accurate accounting of the treatment, care, and events surrounding the patient’s/subject’s involvement in the Study. All Study records shall be complete and
up-to-date.
19.3 CRO will retain all records for the Study produced pursuant to this Agreement for the longest of the following three periods:
(1) two years after FDA approves a New Drug Application for the drug and indication that is the subject of the study,
(2) two years after the termination or withdrawal of the health regulatory agency exemption (e.g., Investigational New Drug
Application (“IND”) under which the Study is conducted),
(3) the record retention period mandated by any federal, state, or local laws or regulations.
CRO will contact SPONSOR at least thirty days before the planned destruction of any Study records, at which time SPONSOR may request that CRO deliver
such records to SPONSOR. CRO shall notify SPONSOR of any accidental loss or destruction of Study records. This provision shall survive the termination
of this Agreement.
20. DELAYS
20.1 SPONSOR acknowledges that CRO will require documents, Study Drugs, data, records and cooperation by SPONSOR in order to
properly perform the Services hereunder and that CRO is not responsible for errors, delays or other consequences to the extent such errors, delays or other
consequences arise solely from the failure of SPONSOR to provide such documents, Study Drugs, data, records or cooperation.
20.2 No party hereto shall be held liable or responsible to any other party nor be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from fire, floods, embargoes,
government regulations, prohibitions or interventions, war, acts of war (whether war is declared or not), insurrections, riots, civil commotions, strikes,
lockouts, acts of God, or any other cause beyond the reasonable control of the affected party; provided, however, that upon the occurrence of such condition,
the party affected thereby gives the other parties prompt written notice thereof, specifying the extent to which its performance hereunder will likely be
affected; and provided, further, that the party affected thereby uses reasonable efforts to mitigate the effects of such condition.
21. MISCELLANEOUS PROVISIONS
21.1 Integration of Agreement. This Agreement constitutes the entire agreement between the parties on the subject matter described herein
and supersedes all prior contracts, agreements, and understandings relating to the same subject matter between the parties. The parties intend this Agreement
to be a complete statement of the terms of their agreement, and no change or modification of any of the provisions of this Agreement shall be effective unless
it is in writing and signed by a duly authorized officer of CRO and SPONSOR.
21.2 Waiver. No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances
shall be deemed to be construed as a further or continuing waiver of such term, provision or condition or of any other term, provision or condition of this
Agreement.
21.3 Governing Law. This Agreement shall be interpreted and given effect under the laws of the State of Delaware without reference to
conflict of law rules.
21.4 Paragraph Headings. The paragraph headings of this Agreement are merely for the convenience of the parties and are not to be
construed as modifying or changing the obligations or conditions expressed in this Agreement.
21.5 Enforceability of Agreement. If any part of this Agreement shall be held to be contrary to law or public policy or otherwise
unenforceable, such finding shall not invalidate any other part of this Agreement.
21.6 Exhibits. References to Exhibits attached to this Agreement shall be deemed to incorporate the entire contents of such Exhibit by
reference thereto, as if it were fully set forth in this Agreement.
21.7 Counterparts. This Agreement may be executed in several counterparts, each of which shall be deemed an original but all of which shall
constitute one and the same instrument.
21.8 Further Action. Each party hereto shall take, or cause to be taken, all actions, and do, or cause to be done, things necessary, proper or
advisable under applicable laws and regulations (including without limitation those regulations promulgated by the U.S. Internal Revenue Service), and
execute and deliver such further, documents as may be reasonably requested by the other party in connection with the operation of this Agreement.
IN WITNESS WHEREOF, SPONSOR and CRO, have caused this Agreement to be executed by their respective duly authorized representatives effective as
of the day and year first above written.
CYTRX CORPORATION ONCOTHERAPEUTICS
By: /s/ STEVEN A. KRIEGSMAN By: /s/ GEOFFREY M. GEE, ESQ.
Name: Steven A. Kriegsman Name: Geoffrey M. Gee, Esq.
Title: President and CEO Title: Chief Operating Officer
EMPLOYMENT AGREEMENT
EXHIBIT 10.25
This Employment Agreement (this “Agreement”) is made and entered into as of January 1, 2011 (the “Effective Date”) by and between CytRx
Corporation, a Delaware corporation (“Employer”), and Daniel Levitt, M.D., Ph.D., an individual and resident of the State of California (“Employee”).
WHEREAS, Employer desires to employ Employee, and Employee is willing to be employed by Employer, on the terms set forth in this
Agreement.
NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties
hereto agree as follows.
1. Employment. Effective as of the Effective Date, Employer shall continue to employ Employee, and Employee shall continue to serve, as
Employer’s Chief Medical Officer on the terms set forth herein.
2. Duties; Places of Employment. Employee shall perform in a professional and business-like manner, and to the best of his ability, the
duties described on Schedule 1 to this Agreement and such other duties as are assigned to him from time to time by Employer’s President and Chief Executive
Officer. Employee understands and agrees that his duties, title and authority may be changed from time to time in the discretion of Employer’s President and
Chief Executive Officer. Subject to the succeeding sentences, Employee’s services hereunder shall be rendered at Employer’s San Francisco office and its
corporate offices in Los Angeles, California, except for travel when and as required in the performance of Employee’s duties hereunder. Employee and
Employer shall consult with each other from time to time regarding the optimal scheduling of Employee’s time at Employer’s San Francisco and corporate
offices. Employee may work remotely from the San Francisco office and during such time, Employee shall make himself readily accessible to Employer by
telephone, via the Internet or other remote access, as Employer and Employee deem reasonably necessary for the performance of Employee’s services
hereunder. Employer shall make available to Employee remote computer access in Employer’s San Francisco office to Employer’s computerized systems and
shall provide technical and hardware support.
3. Time and Efforts. Subject to this Section 3, Employee shall devote all of his business time, efforts, attention and energies to Employer’s
business and to discharge his duties hereunder. Employer agrees that Employee may continue to serve as a director on the board of directors of Aquinox
Corp. and as a director and treasurer of the board of the San Francisco SPCA. In addition, Employee may serve on the board or advisory committee of one
other company or organization from time to time, provided that such company or organization is not directly competitive with Employer and provided that
Employer has consented to such role by Employee, which consent shall not be unreasonably withheld.
4. Term. The term (the “Term”) of Employee’s employment hereunder shall commence on the Effective Date and shall expire on
December 31, 2011, unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew
this Agreement. In the event that Employer does not offer to extend or renew the Agreement, Employer shall continue to pay Employee his salary as provided
for in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2012 or (b) the date of Employee’s full-time re-
employment with another employer, whichever is earlier; provided that, as a condition to Employer’s obligations under this sentence, Employee shall have
executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A. Employee shall notify Employer
immediately in the event Employee accepts such full-time employment with another employer.
5. Compensation. As the total consideration for Employee’s services rendered hereunder, Employer shall pay or provide Employee the
following compensation and benefits:
accordance with Employer’s normal payroll policies and procedures.
5.1. Salary. Employee shall be entitled to receive an annual salary of Four Hundred Fifty Thousand Dollars ($450,000), payable in
5.2. Discretionary Bonus. Employee also may be eligible for a bonus from time to time for his services during the
Term. Employee’s eligibility to receive a bonus, any determination to award Employee such a bonus and, if awarded, the amount thereof, shall be in
Employer’s sole discretion; provided that the bonus payable with respect to calendar year 2011 shall not be less than 25% of Employee’s base salary at the
time that bonus is paid.
5.3. Expense Reimbursement. (a) Employer shall reimburse Employee for reasonable and necessary business expenses incurred
by Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to
time. (b) When Employee travels to Employer’s corporate offices, Employer shall pay for (i) round-trip airfare and airport parking or other ground
transportation to and from the airports, or, (ii) if driving, the cost of gas and meals, but shall not pay for any other food or other incidentals except as
specifically set forth herein. During the Term, Employer shall provide Employee with (i) access to a furnished apartment leased by Employer in reasonable
proximity to Employer’s corporate offices, inclusive of parking, utilities, cable and Internet access, weekly cleaning and laundry service, (ii) Employer-paid
memberships to (x) a health club reasonably near Employer’s corporate offices and (y) one airline club, and (iii) the use of a rental car leased by Employer
with Employer-paid insurance for use while in Los Angeles, California.
5.4. Tax Gross-Ups.
Employee under Section 5.3(b) above (whether paid or payable pursuant to the terms of this Agreement or otherwise, but
(a) Travel and Housing Payments. In the event it shall be determined that any payment by the Employer to or for the benefit of
determined without regard to any additional payments required under this Section 5.4) (a “Travel and Housing Payment”) would be subject to federal or state
income or payroll tax (such income and payroll tax, together with any such interest and penalties, are hereinafter collectively referred to as the “Additional
Section 5.3(b) Income Tax”), then Employee shall be entitled to receive an additional payment (a “Gross-Up Payment”) in an amount such that after payment
by Employee of all taxes (including any interest or penalties imposed with respect to such taxes), including, without limitation, any income taxes (and any
interest and penalties imposed with respect thereto) imposed upon the Gross-Up Payment, Employee retains an amount of the Gross-Up Payment equal to the
Additional Section 5.3(b) Income Tax imposed upon the Travel and Housing Payments.
(b) Change in Control Payments. In the event it shall be determined that any payment or distribution by the Employer to or for the
benefit of Employee (whether paid or payable or distributed or distributable pursuant to the terms of this Agreement, including Section 5.3 above, or
otherwise, but determined without regard to any additional payments required under this Section 5.4) (a “Change in Control Payment”) would be subject to
the excise tax imposed by Section 4999 of the Internal Revenue Code of 1986, as amended (the “Code”) or any interest or penalties are incurred by Employee
with respect to such excise tax (such excise tax, together with any such interest and penalties, are hereinafter collectively referred to as the “Excise Tax”), then
Employee shall be entitled to receive an additional payment (a “Parachute Gross-Up Payment”) in an amount such that after payment by Employee of all
taxes (including any interest or penalties imposed with respect to such taxes), including, without limitation, any income taxes (and any interest and penalties
imposed with respect thereto) and Excise Tax imposed upon the Parachute Gross-Up Payment, Employee retains an amount of the Parachute Gross-Up
Payment equal to the Excise Tax imposed upon the Change in Control Payments
(c) Subject to the provisions of Section 5.4(d) hereof, all determinations required to be made under this Section 5.4, including
whether and when a Gross-Up Payment or a Parachute Gross-Up Payment is required and the amount of such Gross-Up Payment or Parachute Gross-Up
Payment, whichever shall apply, and the assumptions to be used in arriving at such determination, shall be made by the certified public accounting firm
designated by the Employer (the “Accounting Firm”) which shall provide detailed supporting calculations both to the Employer and Employee within 15
business days of the receipt of notice from Employee that there has been a Change in Control Payment or the Travel and Housing Payment is being treated as
taxable income to Employee. All fees and expenses of the Accounting Firm shall be borne solely by the Employer. Any Gross-Up Payment or Parachute
Gross-Up Payment, as determined pursuant to this Section 5.4, shall be paid by the Employer to Employee within five days of the receipt of the Accounting
Firm’s determination. Any determination by the Accounting Firm shall be binding upon the Employer and Employee. As a result of the uncertainty in the
application of Sections 61 or 4999 of the Code at the time of the initial determination by the Accounting Firm hereunder, it is possible that Gross-Up
Payments or Parachute Gross-Up Payments which will not have been made by the Employer should have been made (“Underpayment”), consistent with the
calculations required to be made
hereunder. In the event that the Employer exhausts its remedies pursuant to Section 5.4(d) and Employee thereafter is required to make a payment of any
Additional Section 5.3(b) Income Tax or any Excise Tax, the Accounting Firm shall determine the amount of the Underpayment that has occurred and any
such Underpayment shall be promptly paid by the Employer to or for the benefit of Employee.
(d) Employee shall notify the Employer in writing of any claim by the Internal Revenue Service that, if successful, would require
the payment by the Employer of the Gross-Up Payment or the Parachute Gross-Up Payment. Such notification shall be given as soon as practicable but no
later than thirty days after Employee is informed in writing of such claim and shall apprise the Employer of the nature of such claim and the date on which
such claim is requested to be paid. Employee shall not pay such claim prior to the expiration of the 30-day period following the date on which it gives such
notice to the Employer (or such shorter period ending on the date that any payment of taxes with respect to such claim is due). If the Employer notifies
Employee in writing prior to the expiration of such period that it desires to contest such claim, Employee shall: give the Employer any information
reasonably requested by the Employer relating to such claim,
time to time, including, without limitation, accepting legal representation with respect to such claim by an attorney reasonably selected by the Employer,
(i) take such action in connection with contesting such claim as the Employer shall reasonably request in writing from
(ii) cooperate with the Employer in good faith in order effectively to contest such claim, and
(iii) permit the Employer to participate in any proceedings relating to such claim;
provided, however, that the Employer shall bear and pay directly all costs and expenses (including additional interest and penalties) incurred in connection
with such contest and shall indemnify and hold Employee harmless, on an after-tax basis, for any Excise Tax or income tax (including interest and penalties
with respect thereto) imposed as a result of such representation and payment of costs and expenses. Without limitation of the foregoing provisions to this
Section 5.4(d), the Employer shall control all proceedings taken in connection with such contest and, at its sole option, may pursue or forgo any and all
administrative appeals, proceedings, hearings and conferences with the taxing authority in respect of such claim.
Employer’s vacation policy in effect from time to time.
5.5. Vacation. Employee shall be entitled to twenty business days of vacation each year during the Term in accordance with
available generally by Employer to all of its employees under its group plans and employment policies in effect
5.6. Employee Benefits. Employee shall be eligible to participate in any medical insurance and other employee benefits made
during the Term. Schedule 2 hereto sets forth a summary of such plans and policies as currently in effect. Employee acknowledges and agrees that, any such
plans or policies now or hereafter in effect may be modified or terminated by Employer at any time in its discretion.
5.7. Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any
and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter
enacted or required as a charge on the compensation or benefits of Employee.
6. Termination. This Agreement may be terminated as set forth in this Section 6.
Employee. “Cause” for this purpose shall mean any of the following:
6.1. Termination by Employer for Cause. Employer may terminate Employee’s employment hereunder for “Cause” upon notice to
(a) Employee’s breach of any material term of this Agreement; provided that the first occasion of any particular breach
shall not constitute such Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording
Employee at least ten business days to correct such breach;
turpitude;
(b) Employee’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral
(c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
notice from Employer stating the nature of such failure or refusal and affording Employee at least ten business days to correct the same;
(d) Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written
of the Board), indicates alcohol or drug abuse by Employee; or
(e) Employee’s act or omission that, in the reasonable determination of Employer’s Board of Directors (or a Committee
(f) Employee’s act or personal conduct that, in the judgment of Employer’s Board of Directors (or a Committee of the
Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of
harassment, or other similar liabilities to subordinate employees.
Upon termination of Employee’s employment by Employer for Cause, all compensation and benefits to Employee hereunder shall cease and
Employee shall be entitled only to payment, not later than three days after the date of termination, of any accrued but unpaid salary and unused vacation as
provided in Sections 5.1 and 5.5 as of the date of such termination and any unpaid bonus that may have been earned or awarded Employee as provided in
Section 5.2 prior to such date.
6.2. Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause upon ten
days notice to Employee. Upon termination of Employee’s employment by Employer without Cause, all compensation and benefits to Employee hereunder
shall cease and Employee shall be entitled to (a) payment of (1) any accrued but unpaid salary, the minimum bonus described in Section 5.2 applied to the
base salary paid through the date of termination, any Tax Gross-Up or Parachute Tax Gross-Up payment as described in Section 5.4 and unused vacation as of
the date of such termination as required by California law, which shall be due and payable upon the effective date of such termination, and (2) an amount,
which shall be due and payable within ten days following the effective date of such termination, equal to six months’ salary as provided in Section 5.1, and (b)
continued participation, at Employer’s cost and expense, for a period of six months following such termination, in any Employer-sponsored group benefit
plans in which Employee was participating as of the date of termination, provided that, as a condition to Employer’s obligations under Section 6.2(a)(2) and
6.2(b), Employee shall have executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A.
6.3. Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice
from Employer in event of his permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of
disability insurance maintained by Employer (or by Employee, as the case may be) with respect to Employee or, if no such policy is then in effect, shall mean
Employee’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not
consecutive. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employer shall
pay to the Employee’s heirs or personal representatives, not later than ten days after the date of termination, any accrued but unpaid salary, the minimum
bonus described in Section 5.2 applied to the base salary paid through the date of termination, any Tax Gross-Up or Parachute Tax Gross-Up payment as
described in Section 5.4 and unused vacation as of the date of such termination as required by California law.
7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, Employee shall hold and keep secret and
confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of Employer and shall use such
information only in the course of performing Employee’s duties hereunder; provided, however, that with respect to trade secrets, Employee shall hold and
keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. Employee shall maintain in trust all such trade
secrets or other confidential or proprietary information, as Employer’s property, including, but not limited to, all documents concerning Employer’s business,
including Employee’s work papers, telephone directories, customer information and notes, and any and all copies thereof in Employee’s possession or under
Employee’s control. Upon the expiration or earlier termination of Employee’s employment with Employer, or upon request by Employer, Employee shall
deliver to Employer all such documents belonging to Employer, including any and all copies in Employee’s possession or under Employee’s control.
8. Equitable Remedies; Injunctive Relief. Employee hereby acknowledges and agrees that monetary damages are inadequate to fully
compensate Employer for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that Employer
shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and
permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however,
diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
9. Indemnification; Insurance. Employer and Employee acknowledge that, as the Chief Medical Officer of the Employer, Employee shall be
a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent provided by Employer to its officers, directors
and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement. Effective on the Effective Date,
Employer shall maintain Employee as an additional insured under its current policy of directors and officers liability insurance and shall use commercially
reasonable efforts to continue to insure Employee thereunder, or under any replacement policies in effect from time to time, during the Term.
10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or
otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless
be binding and enforceable.
11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon Employer, its successors and assigns and
Employee and his heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other
party.
12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties
hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This
Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter
hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that
any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.
13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such
writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this
Agreement be enforceable or valid.
14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without
giving effect to California’s choice-of-law rules.
15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to
Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to
such other address as such party may have specified by notice given to the other party pursuant to this provision):
If to Employer:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Facsimile: (310) 826-5529
Attention: Chief Executive Officer
If to Employee:
Daniel Levitt, M.D., Ph.D.
_______________
16. Survival. Sections 5.4, 6.2., 6.3, 7 through 16 and 18 shall survive the expiration or termination of this Agreement.
17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an
originally executed counterpart.
18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled
to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.
19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm's length between persons
knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly,
the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law
principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and
is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.
IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.
“EMPLOYER”
CytRx Corporation
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
President & Chief Executive Officer
“EMPLOYEE”
/s/ DANIEL
LEVITT
Daniel Levitt, M.D., Ph.D.
EMPLOYMENT AGREEMENT
EXHIBIT 10.26
This Employment Agreement (this “Agreement”) is made and entered into as of January 1, 2011 (the “Effective Date”) by and between CytRx
Corporation, a Delaware corporation (“Employer”), and Scott Geyer, an individual and resident of the State of California (“Employee”).
WHEREAS, Employer desires to employ Employee, and Employee is willing to be employed by Employer, on the terms set forth in this
Agreement.
NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties
hereto agree as follows.
1. Employment. Effective as of the Effective Date, Employer shall continue to employ Employee, and Employee shall continue to serve, as
Employer’s Senior Vice President – Manufacturing on the terms set forth herein.
2. Duties; Place of Employment. Employee shall perform in a professional and business-like manner, and to the best of his ability, the duties
described on Schedule 1 to this Agreement and such other duties as are assigned to him from time to time by Employer’s President and Chief Executive
Officer. Employee understands and agrees that his duties, title and authority may be changed from time to time in the discretion of Employer’s President and
Chief Executive Officer. Subject to the succeeding sentences, Employee’s services hereunder shall be rendered at Employer’s corporate offices in Los
Angeles, California, except for travel when and as required in the performance of Employee’s duties hereunder. Employee generally shall be required to be
physically present, and to perform his services hereunder, at Employee’s corporate headquarters not less than five business days per month, which shall
include each in-person meeting of Employer’s Board of Directors and at least one senior management meeting per month. Employee and Employer shall
consult with each other from time to time regarding the optimal scheduling of Employee’s time at Employer’s corporate offices. When not present at
Employer’s corporate offices, Employee shall make himself readily accessible to Employer by telephone, via the Internet or other remote access, as Employer
deems reasonably necessary for the performance of Employee’s services hereunder.
3. Time and Efforts. Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and to discharge
his duties hereunder.
4. Term. The term (the “Term”) of Employee’s employment hereunder shall commence on the Effective Date and shall expire on
December 31, 2011, unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew
this Agreement. In the event that Employer does not offer to extend or renew the Agreement, Employer shall continue to pay Employee his salary as provided
for in Section 5.1 during the period commencing on the final date of the
Term and ending on (a) June 30, 2012 or (b) the date of Employee’s re-employment with another employer, whichever is earlier; provided that, as a condition
to Employer’s obligations under this sentence, Employee shall have executed and delivered to Employer a Separation Agreement and General Release in the
form attached hereto as Exhibit A. Employee shall notify Employer immediately in the event Employee accepts such employment with another employer.
5. Compensation. As the total consideration for Employee’s services rendered hereunder, Employer shall pay or provide Employee the
following compensation and benefits:
accordance with Employer’s normal payroll policies and procedures.
5.1. Salary. Employee shall be entitled to receive an annual salary of Three Hundred Thousand Dollars ($300,000), payable in
5.2. Discretionary Bonus. Employee also may be eligible for a bonus from time to time for his services during the
Term. Employee’s eligibility to receive a bonus, any determination to award Employee such a bonus and, if awarded, the amount thereof, shall be in
Employer’s sole discretion.
5.3. Expense Reimbursement. Employer shall reimburse Employee for reasonable and necessary business expenses incurred by
Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to
time. When Employee travels to Employer’s corporate offices, Employer shall pay for reasonable lodging and transportation (including flights), but shall not
pay for food or other incidentals.
Employer’s vacation policy in effect from time to time.
5.4. Vacation. Employee shall be entitled to twenty business days of vacation each year during the Term in accordance with
5.5. Employee Benefits. Employee shall be eligible to participate in any medical insurance and other employee benefits made
available generally by Employer to all of its employees under its group plans and employment policies in effect during the Term. Schedule 2 hereto sets forth
a summary of such plans and policies as currently in effect. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect
may be modified or terminated by Employer at any time in its discretion.
5.6. Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any
and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter
enacted or required as a charge on the compensation or benefits of Employee.
6. Termination. This Agreement may be terminated as set forth in this Section 6.
6.1. Termination by Employer for Cause. Employer may terminate Employee’s employment hereunder for “Cause” upon notice to
Employee. “Cause” for this purpose shall mean any of the following:
(a) Employee’s breach of any material term of this Agreement; provided that the first occasion of any particular breach
shall not constitute such Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording
Employee at least ten days to correct such breach;
turpitude;
(b) Employee’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral
(c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
(d) Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written
of the Board), indicates alcohol or drug abuse by Employee; or
(e) Employee’s act or omission that, in the reasonable determination of Employer’s Board of Directors (or a Committee
(f) Employee’s act or personal conduct that, in the judgment of Employer’s Board of Directors (or a Committee of the
Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of
harassment, or other similar liabilities to subordinate employees.
Upon termination of Employee’s employment by Employer for Cause, all compensation and benefits to Employee hereunder shall cease and
Employee shall be entitled only to payment, not later than three days after the date of termination, of any accrued but unpaid salary and unused vacation as
provided in Sections 5.1 and 5.5 as of the date of such termination and any unpaid bonus that may have been earned or awarded Employee as provided in
Section 5.2 prior to such date.
6.2. Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause upon ten
days notice to Employee. Upon termination of Employee’s employment by Employer without Cause, all compensation and benefits to Employee hereunder
shall cease and Employee shall be entitled to (a) payment of (1) any accrued but unpaid salary and unused vacation as of the date of such termination as
required by California law, which shall be due and payable upon the effective date of such termination, and (2) an amount, which shall be due and payable
within ten days following the effective date of such termination, equal to six months’ salary as provided in Section 5.1, and (b) continued participation, at
Employer’s cost and expense, for a period of six months following such termination, in any Employer-sponsored group benefit plans in which Employee was
participating as of the date of termination, provided that, as a condition to Employer’s obligations under Section 6.2(a)(2) and 6.2(b), Employee shall have
executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A.
6.3. Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice
from Employer in event of his permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of
disability insurance maintained by Employer (or by Employee, as the case may be) with respect to Employee or, if no such policy is then in effect, shall mean
Employee’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not
consecutive. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employer shall
pay to the Employee’s heirs or personal representatives, not later than ten days after the date of termination, any accrued but unpaid salary and unused
vacation as of the date of such termination as required by California law.
7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, Employee shall hold and keep secret and
confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of Employer and shall use such
information only in the course of performing Employee’s duties hereunder; provided, however, that with respect to trade secrets, Employee shall hold and
keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. Employee shall maintain in trust all such trade
secrets or other confidential or proprietary information, as Employer’s property, including, but not limited to, all documents concerning Employer’s business,
including Employee’s work papers, telephone directories, customer information and notes, and any and all copies thereof in Employee’s possession or under
Employee’s control. Upon the expiration or earlier termination of Employee’s employment with Employer, or upon request by Employer, Employee shall
deliver to Employer all such documents belonging to Employer, including any and all copies in Employee’s possession or under Employee’s control.
8. Equitable Remedies; Injunctive Relief. Employee hereby acknowledges and agrees that monetary damages are inadequate to fully
compensate Employer for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that Employer
shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and
permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however,
diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
9. Indemnification; Insurance. Employer and Employee acknowledge that, as the Senior Vice President – Manufacturing of the Employer,
Employee shall be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent provided by Employer to its
officers, directors and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement. Subject to his
insurability thereunder, effective the Effective Date, Employer shall add Employee as an additional insured under its current policy of directors and officers
liability insurance and shall use commercially reasonable efforts to continue to insure Employee thereunder, or under any replacement policies in effect from
time to time, during the Term.
10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or
otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless
be binding and enforceable.
11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon Employer, its successors and assigns and
Employee and his heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other
party.
12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties
hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This
Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter
hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that
any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.
13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such
writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this
Agreement be enforceable or valid.
14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without
giving effect to California’s choice-of-law rules.
15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to
Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to
such other address as such party may have specified by notice given to the other party pursuant to this provision):
If to Employer:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Facsimile: (310) 826-5529
Attention: Chief Executive Officer
If to Employee:
Scott Geyer
__________________
16. Survival. Sections 7 through 16, 18 and 19 shall survive the expiration or termination of this Agreement.
17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an
originally executed counterpart.
18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled
to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.
19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm's length between persons
knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly,
the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law
principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and
is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.
IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.
“EMPLOYER”
CytRx Corporation
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
President & Chief Executive Officer
“EMPLOYEE”
/s/ SCOTT
GEYER
Scott Geyer
EMPLOYMENT AGREEMENT
EXHIBIT 10.27
This Employment Agreement (this “Agreement”) is made and entered into as of January 1, 2011 (the “Effective Date”) by and between CytRx
Corporation, a Delaware corporation (“Employer”), and Benjamin S. Levin, an individual and resident of the State of California (“Employee”).
WHEREAS, Employer desires to employ Employee, and Employee is willing to be employed by Employer, on the terms set forth in this
Agreement.
NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties
hereto agree as follows.
1. Employment. Effective as of the Effective Date, Employer shall continue to employ Employee, and Employee shall continue to serve, as
Employer’s General Counsel, Vice President – Legal Affairs and Corporate Secretary on the terms set forth herein.
2. Duties; Place of Employment. Employee shall perform in a professional and business-like manner, and to the best of his ability, the duties
described on Schedule 1 to this Agreement and such other duties as are assigned to him from time to time by Employer’s President and Chief Executive
Officer. Employee understands and agrees that his duties, title and authority may be changed from time to time in the discretion of Employer’s President and
Chief Executive Officer. Employee’s services hereunder shall be rendered at Employer’s principal executive office, except for travel when and as required in
the performance of Employee’s duties hereunder. Notwithstanding the foregoing, Employer understands and agrees that Employee shall be entitled to render
his services hereunder from his home on Friday of each week except as required by Employer in extraordinary circumstances.
3. Time and Efforts. Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and to discharge
his duties hereunder.
4. Term. The term (the “Term”) of Employee’s employment hereunder shall commence on the Effective Date and shall expire on December
31, 2011, unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew this
Agreement. In the event that Employer does not offer to extend or renew the Agreement, Employer shall continue to pay Employee his salary as provided for
in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2012 or (b) the date of Employee’s re-employment with
another employer, whichever is earlier; provided that, as a condition to Employer’s obligations under this sentence, Employee shall have executed and
delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A. Employee shall notify Employer immediately
in the event Employee accepts such employment with another employer.
5. Compensation. As the total consideration for Employee’s services rendered hereunder, Employer shall pay or provide Employee the
following compensation and benefits:
in accordance with Employer’s normal payroll policies and procedures.
5.1. Salary. Employee shall be entitled to receive an annual salary of Three Hundred FortyThousand Dollars ($340,000), payable
5.2. Discretionary Bonus. Employee also may be eligible for a bonus from time to time for his services during the
Term. Employee’s eligibility to receive a bonus, any determination to award Employee such a bonus and, if awarded, the amount thereof shall be in
Employer’s sole discretion.
5.3. Expense Reimbursement. Employer shall reimburse Employee for reasonable and necessary business expenses incurred by
Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to time.
Employer’s vacation policy in effect from time to time.
5.4. Vacation. Employee shall be entitled to twenty business days of vacation each year during the Term in accordance with
5.5. Tax Gross-Up. In the event that the severance and other benefits provided for in this Agreement or otherwise payable to the
Employee (i) constitute “parachute payments” within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed by Section
4999 of the Code (the “Excise Tax”), then the Employee’s benefits under this Agreement shall be either: (x) delivered in full, or (y) delivered as to such lesser
extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the
applicable federal, state and local income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis, of the greatest amount of benefits,
notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code. Unless Employer and the Employee otherwise
agree in writing, any determination required under this Section 1 shall be made in writing by Employer’s independent public accountants (the “Accountants”),
whose determination shall be conclusive and binding upon the Employee and Employer for all purposes. For purposes of making the calculations required by
this Section 1, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith
interpretations concerning the application of Sections 280G and 4999 of the Code. Employer and the Employee shall furnish to the Accountants such
information and documents as the Accountants may reasonably request in order to make a determination under this Section 5.5. Employer shall bear all costs
the Accountants may reasonably incur in connection with any calculations contemplated by this Section 5.5.
5.6. Employee Benefits. Employee shall be eligible to participate in any medical insurance and other employee benefits made
available by Employer to all of its employees under its group plans and employment policies in effect during the Term. Schedule 2 hereto sets forth a
summary of such plans and policies as currently in effect. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect may
be modified or terminated by Employer at any time in its discretion.
5.7. Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any
and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter
enacted or required as a charge on the compensation or benefits of Employee.
6. Termination. This Agreement may be terminated as set forth in this Section 6.
Employee. “Cause” for this purpose shall mean any of the following:
6.1. Termination by Employer for Cause. Employer may terminate Employee’s employment hereunder for “Cause” upon notice to
(a) Employee’s breach of any material term of this Agreement; provided that the first occasion of any particular breach
shall not constitute such Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording
Employee at least ten days to correct such breach;
turpitude;
(b) Employee’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral
(c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
(d) Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written
of the Board), indicates alcohol or drug abuse by Employee; or
(e) Employee’s act or omission that, in the reasonable determination of Employer’s Board of Directors (or a Committee
(f) Employee’s act or personal conduct that, in the judgment of Employer’s Board of Directors (or a Committee of the
Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of
harassment, or other similar liabilities to subordinate employees.
Upon termination of Employee’s employment by Employer for Cause, all compensation and benefits to Employee hereunder shall cease and
Employee shall be entitled only to payment, not later than three days after the date of termination, of any accrued but unpaid salary and unused vacation as
provided in Sections 5.1 and 5.5 as of the date of such termination and any unpaid bonus that may have been awarded Employee as provided in Section 5.2
prior to such date.
6.2. Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause upon ten
days notice to Employee. Upon termination of Employee’s employment by Employer without Cause, all compensation and benefits to Employee hereunder
shall cease and Employee shall be entitled to (a) payment of (1) any accrued but unpaid salary and unused vacation as of the date of such termination as
required by California law, which shall be due and payable upon the effective date of such termination, and (2) an amount, which shall be due and payable
within ten days following the effective date of such termination, equal to six months’ salary as provided in Section 5.1, and (b) continued participation, at
Employer’s cost and expense, for a period of six months following such termination, in any Employer-sponsored group benefit plans in which Employee was
participating as of the date of termination, provided that, as a condition to Employer’s obligations under Section 6.2(a)(2) and 6.2(b), Employee shall have
executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A.
6.3. Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice
from Employer in event of his permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of
disability insurance maintained by Employer (or by Employee, as the case may be) with respect to Employee or, if no such policy is then in effect, shall mean
Employee’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not
consecutive. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employer shall
pay to the Employee’s heirs or personal representatives, not later than ten days after the date of termination, any accrued but unpaid salary and unused
vacation as of the date of such termination as required by California law.
7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, Employee shall hold and keep secret and
confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of Employer and shall use such
information only in the course of performing Employee’s duties hereunder; provided, however, that with respect to trade secrets, Employee shall hold and
keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. Employee shall maintain in trust all such trade
secrets or other confidential or proprietary information, as Employer’s property, including, but not limited to, all documents concerning Employer’s business,
including Employee’s work papers, telephone directories, customer information and notes, and any and all copies thereof in Employee’s possession or under
Employee’s control. Upon the expiration or earlier termination of Employee’s employment with Employer, or upon request by Employer, Employee shall
deliver to Employer all such documents belonging to Employer, including any and all copies in Employee’s possession or under Employee’s control.
8. Equitable Remedies; Injunctive Relief. Employee hereby acknowledges and agrees that monetary damages are inadequate to fully
compensate Employer for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that Employer
shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and
permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however,
diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
9. Indemnification; Insurance. Employer and Employee acknowledge that, as the General Counsel, Vice President – Legal Affairs and
Corporate Secretary of the Employer, Employee shall be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the
full extent provided by Employer to its officers, directors and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date
of this Agreement. Employer shall maintain Employee as an additional insured under its current policy of directors and officers liability insurance and shall
use commercially reasonable efforts to continue to insure Employee thereunder, or under any replacement policies in effect from time to time, during the
Term.
10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or
otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless
be binding and enforceable.
11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon Employer, its successors and assigns and
Employee and his heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other
party.
12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties
hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This
Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter
hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that
any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.
13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such
writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this
Agreement be enforceable or valid.
14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without
giving effect to California’s choice-of-law rules.
15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to
Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to
such other address as such party may have specified by notice given to the other party pursuant to this provision):
If to Employer:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Facsimile: (310) 826-5529
Attention: Chief Executive Officer
If to Employee:
__________________
__________________
__________________
16. Survival. Sections 7 through 16, 18 and 19 shall survive the expiration or termination of this Agreement.
17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an
originally executed counterpart.
18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled
to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.
19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm's length between persons
knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly,
the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law
principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and
is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.
IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.
“EMPLOYER”
CytRx Corporation
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
Chief Executive Officer
“EMPLOYEE”
/s/ BENJAMIN S.
LEVIN
Benjamin S. Levin
EMPLOYMENT AGREEMENT
EXHIBIT 10.28
This Employment Agreement (this “Agreement”) is made and entered into as of January 1, 2011 (the “Effective Date”) by and between CytRx
Corporation, a Delaware corporation (“Employer”), and Scott Wieland, an individual and resident of the State of California (“Employee”).
WHEREAS, Employer desires to employ Employee, and Employee is willing to be employed by Employer, on the terms set forth in this
Agreement.
NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties
hereto agree as follows.
1. Employment. Effective as of the Effective Date, Employer shall continue to employ Employee, and Employee shall continue to serve, as
Employer’s Senior Vice President – Drug Development on the terms set forth herein.
2. Duties; Place of Employment. Employee shall perform in a professional and business-like manner, and to the best of his ability, the duties
described on Schedule 1 to this Agreement and such other duties as are assigned to him from time to time by Employer’s President and Chief Executive
Officer. Employee understands and agrees that his duties, title and authority may be changed from time to time in the discretion of Employer’s President and
Chief Executive Officer. Employee’s services hereunder shall be rendered at Employer’s principal executive office, except for travel when and as required in
the performance of Employee’s duties hereunder. Notwithstanding the foregoing, Employer understands and agrees that Employee shall be entitled to render
his services hereunder from his home one week of each month except as required by Employer in extraordinary circumstances.
3. Time and Efforts. Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and to discharge
his duties hereunder. Notwithstanding any other provision of this Section 3, while this Agreement is in effect, Employee may serve on the board of directors
of one company other than Employer, but in no event shall Employee serve on the board of directors of a company that is directly competitive with Employer.
4. Term. The term (the “Term”) of Employee’s employment hereunder shall commence on the Effective Date and shall expire on December
31, 2011, unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew this
Agreement. In the event that Employer does not offer to extend or renew the Agreement, Employer shall continue to pay Employee his salary as provided for
in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2012 or (b) the date of Employee’s re-employment with
another employer, whichever is earlier; provided that, as a condition to Employer’s obligations under this sentence, Employee shall have executed and
delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A. Employee shall notify Employer immediately
in the event Employee accepts such employment with another employer.
5. Compensation. As the total consideration for Employee’s services rendered hereunder, Employer shall pay or provide Employee the
following compensation and benefits:
in accordance with Employer’s normal payroll policies and procedures.
5.1. Salary. Employee shall be entitled to receive an annual salary of Three Hundred Thirty Thousand Dollars ($330,000), payable
5.2. Discretionary Bonus. Employee also may be eligible for a bonus from time to time for his services during the
Term. Employee’s eligibility to receive a bonus, any determination to award Employee such a bonus and, if awarded, the amount thereof shall be in
Employer’s sole discretion.
5.3. Expense Reimbursement. Employer shall reimburse Employee for reasonable and necessary business expenses incurred by
Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to time.
Employer’s vacation policy in effect from time to time.
5.4. Vacation. Employee shall be entitled to twenty business days of vacation each year during the Term in accordance with
5.5. Tax Gross-Up. In the event that the severance and other benefits provided for in this Agreement or otherwise payable to the
Employee (i) constitute “parachute payments” within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed by Section
4999 of the Code (the “Excise Tax”), then the Employee’s benefits under this Agreement shall be either: (x) delivered in full, or (y) delivered as to such lesser
extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the
applicable federal, state and local income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis, of the greatest amount of benefits,
notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code. Unless Employer and the Employee otherwise
agree in writing, any determination required under this Section 1 shall be made in writing by Employer’s independent public accountants (the “Accountants”),
whose determination shall be conclusive and binding upon the Employee and Employer for all purposes. For purposes of making the calculations required by
this Section 1, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith
interpretations concerning the application of Sections 280G and 4999 of the Code. Employer and the Employee shall furnish to the Accountants such
information and documents as the Accountants may reasonably request in order to make a determination under this Section 5.5. Employer shall bear all costs
the Accountants may reasonably incur in connection with any calculations contemplated by this Section 5.5.
5.6. Employee Benefits. Employee shall be eligible to participate in any medical insurance and other employee benefits made
available by Employer to all of its employees under its group plans and employment policies in effect during the Term. Schedule 2 hereto sets forth a
summary of such plans and policies as currently in effect. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect may
be modified or terminated by Employer at any time in its discretion.
5.7. Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any
and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter
enacted or required as a charge on the compensation or benefits of Employee.
6. Termination. This Agreement may be terminated as set forth in this Section 6.
Employee. “Cause” for this purpose shall mean any of the following:
6.1. Termination by Employer for Cause. Employer may terminate Employee’s employment hereunder for “Cause” upon notice to
(a) Employee’s breach of any material term of this Agreement; provided that the first occasion of any particular breach
shall not constitute such Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording
Employee at least ten days to correct such breach;
turpitude;
(b) Employee’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral
(c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
(d) Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written
of the Board), indicates alcohol or drug abuse by Employee; or
(e) Employee’s act or omission that, in the reasonable determination of Employer’s Board of Directors (or a Committee
(f) Employee’s act or personal conduct that, in the judgment of Employer’s Board of Directors (or a Committee of the
Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of
harassment, or other similar liabilities to subordinate employees.
Upon termination of Employee’s employment by Employer for Cause, all compensation and benefits to Employee hereunder shall cease and
Employee shall be entitled only to payment, not later than three days after the date of termination, of any accrued but unpaid salary and unused vacation as
provided in Sections 5.1 and 5.5 as of the date of such termination and any unpaid bonus that may have been awarded Employee as provided in Section 5.2
prior to such date.
6.2. Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause upon ten
days notice to Employee. Upon termination of Employee’s employment by Employer without Cause, all compensation and benefits to Employee hereunder
shall cease and Employee shall be entitled to (a) payment of (1) any accrued but unpaid salary and unused vacation as of the date of such termination as
required by California law, which shall be due and payable upon the effective date of such termination, and (2) an amount, which shall be due and payable
within ten days following the effective date of such termination, equal to six months’ salary as provided in Section 5.1, and (b) continued participation, at
Employer’s cost and expense, for a period of six months following such termination, in any Employer-sponsored group benefit plans in which Employee was
participating as of the date of termination, provided that, as a condition to Employer’s obligations under Section 6.2(a)(2) and 6.2(b), Employee shall have
executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A.
6.3. Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice
from Employer in event of his permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of
disability insurance maintained by Employer (or by Employee, as the case may be) with respect to Employee or, if no such policy is then in effect, shall mean
Employee’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not
consecutive. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employer shall
pay to the Employee’s heirs or personal representatives, not later than ten days after the date of termination, any accrued but unpaid salary and unused
vacation as of the date of such termination as required by California law.
7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, Employee shall hold and keep secret and
confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of Employer and shall use such
information only in the course of performing Employee’s duties hereunder; provided, however, that with respect to trade secrets, Employee shall hold and
keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. Employee shall maintain in trust all such trade
secrets or other confidential or proprietary information, as Employer’s property, including, but not limited to, all documents concerning Employer’s business,
including Employee’s work papers, telephone directories, customer information and notes, and any and all copies thereof in Employee’s possession or under
Employee’s control. Upon the expiration or earlier termination of Employee’s employment with Employer, or upon request by Employer, Employee shall
deliver to Employer all such documents belonging to Employer, including any and all copies in Employee’s possession or under Employee’s control.
8. Equitable Remedies; Injunctive Relief. Employee hereby acknowledges and agrees that monetary damages are inadequate to fully
compensate Employer for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that Employer
shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and
permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however,
diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
9. Indemnification; Insurance. Employer and Employee acknowledge that, as the Senior Vice President – Drug Development of the
Employer, Employee shall be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent provided by
Employer to its officers, directors and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this
Agreement. Employer shall maintain Employee as an additional insured under its current policy of directors and officers liability insurance and shall use
commercially reasonable efforts to continue to insure Employee thereunder, or under any replacement policies in effect from time to time, during the Term.
10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or
otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless
be binding and enforceable.
11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon Employer, its successors and assigns and
Employee and his heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other
party.
12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties
hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This
Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter
hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that
any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.
13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such
writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this
Agreement be enforceable or valid.
14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without
giving effect to California’s choice-of-law rules.
15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to
Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to
such other address as such party may have specified by notice given to the other party pursuant to this provision):
If to Employer:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Facsimile: (310) 826-5529
Attention: Chief Executive Officer
If to Employee:
__________________
__________________
__________________
16. Survival. Sections 7 through 16, 18 and 19 shall survive the expiration or termination of this Agreement.
17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an
originally executed counterpart.
18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled
to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.
19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm's length between persons
knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly,
the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law
principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and
is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.
IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.
“EMPLOYER”
CytRx Corporation
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
President and Chief Executive Officer
“EMPLOYEE”
/s/ SCOTT
WIELAND
Scott Wieland
EMPLOYMENT AGREEMENT
EXHIBIT 10.29
This Employment Agreement (this “Agreement”) is made and entered into as of January 1, 2011 (the “Effective Date”) by and between CytRx
Corporation, a Delaware corporation (“Employer”), and John Caloz, an individual and resident of the State of California (“Employee”).
WHEREAS, Employer desires to employ Employee, and Employee is willing to be employed by Employer, on the terms set forth in this
Agreement.
NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties
hereto agree as follows.
1. Employment. Effective as of the Effective Date, Employer shall continue to employ Employee, and Employee shall continue to serve, as
Employer’s Chief Financial Officer on the terms set forth herein.
2. Duties; Place of Employment. Employee shall perform in a professional and business-like manner, and to the best of his ability, the duties
described on Schedule 1 to this Agreement and such other duties as are assigned to him from time to time by Employer’s President and Chief Executive
Officer. Employee understands and agrees that his duties, title and authority may be changed from time to time in the discretion of Employer’s President and
Chief Executive Officer. Employee’s services hereunder shall be rendered at Employer’s principal executive office, except for travel when and as required in
the performance of Employee’s duties hereunder.
3. Time and Efforts. Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and to discharge
his duties hereunder.
4. Term. The term (the “Term”) of Employee’s employment hereunder shall commence on the Effective Date and shall expire on December
31, 2011, unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew this
Agreement. In the event that Employer does not offer to extend or renew the Agreement, Employer shall continue to pay Employee his salary as provided for
in Section 5.1 during the period commencing on the final date of the Term and ending on (a) June 30, 2012 or (b) the date of Employee’s re-employment with
another employer, whichever is earlier; provided that, as a condition to Employer’s obligations under this sentence, Employee shall have executed and
delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A. Employee shall notify Employer immediately
in the event Employee accepts such employment with another employer.
5. Compensation. As the total consideration for Employee’s services rendered hereunder, Employer shall pay or provide Employee the
following compensation and benefits:
S2 -
5.1. Salary. Employee shall be entitled to receive an annual salary of Three Hundred Thirty Five Thousand Dollars ($335,000), payable in
accordance with Employer’s normal payroll policies and procedures.
5.2. Discretionary Bonus. Employee also may be eligible for a bonus from time to time for his services during the
Term. Employee’s eligibility to receive a bonus, any determination to award Employee such a bonus and, if awarded, the amount thereof shall be in
Employer’s sole discretion.
5.3. Expense Reimbursement. Employer shall reimburse Employee for reasonable and necessary business expenses incurred by
Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to time.
Employer’s vacation policy in effect from time to time.
5.4. Vacation. Employee shall be entitled to twenty business days of vacation each year during the Term in accordance with
5.5. Tax Gross-Up. In the event that the severance and other benefits provided for in this Agreement or otherwise payable to the
Employee (i) constitute “parachute payments” within the meaning of Section 280G of the Code, and (ii) would be subject to the excise tax imposed by Section
4999 of the Code (the “Excise Tax”), then the Employee’s benefits under this Agreement shall be either: (x) delivered in full, or (y) delivered as to such lesser
extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the
applicable federal, state and local income taxes and the Excise Tax, results in the receipt by Employee on an after-tax basis, of the greatest amount of benefits,
notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code. Unless Employer and the Employee otherwise
agree in writing, any determination required under this Section 1 shall be made in writing by Employer’s independent public accountants (the “Accountants”),
whose determination shall be conclusive and binding upon the Employee and Employer for all purposes. For purposes of making the calculations required by
this Section 1, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith
interpretations concerning the application of Sections 280G and 4999 of the Code. Employer and the Employee shall furnish to the Accountants such
information and documents as the Accountants may reasonably request in order to make a determination under this Section 5.5. Employer shall bear all costs
the Accountants may reasonably incur in connection with any calculations contemplated by this Section 5.5.
5.6. Employee Benefits. Employee shall be eligible to participate in any medical insurance and other employee benefits made
available by Employer to all of its employees under its group plans and employment policies in effect during the Term. Schedule 2 hereto sets forth a
summary of such plans and policies as currently in effect. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect may
be modified or terminated by Employer at any time in its discretion.
5.7. Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any
and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter
enacted or required as a charge on the compensation or benefits of Employee.
6. Termination. This Agreement may be terminated as set forth in this Section 6.
Employee. “Cause” for this purpose shall mean any of the following:
6.1. Termination by Employer for Cause. Employer may terminate Employee’s employment hereunder for “Cause” upon notice to
(a) Employee’s breach of any material term of this Agreement; provided that the first occasion of any particular breach
shall not constitute such Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording
Employee at least ten days to correct such breach;
turpitude;
(b) Employee’s conviction of, or plea of guilty or nolo contendere to, any misdemeanor, felony or other crime of moral
(c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
(d) Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written
of the Board), indicates alcohol or drug abuse by Employee;
(e) Employee’s act or omission that, in the reasonable determination of Employer’s Board of Directors (or a Committee
(f) Employee’s act or personal conduct that, in the judgment of Employer’s Board of Directors (or a Committee of the
Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of
harassment, or other similar liabilities to subordinate employees; or
agreement dated September 22, 2010 between Employer and Employee.
(g) Until September 22, 2011, Employee’s act or personal conduct as described in Paragraph 2 of that certain letter
Upon termination of Employee’s employment by Employer for Cause, all compensation and benefits to Employee hereunder shall cease and
Employee shall be entitled only to payment, not later than three days after the date of termination, of any accrued but unpaid salary and unused vacation as
provided in Sections 5.1 and 5.5 as of the date of such termination and any unpaid bonus that may have been awarded Employee as provided in Section 5.2
prior to such date.
6.2. Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause upon ten
days notice to Employee. Upon termination of Employee’s employment by Employer without Cause, all compensation and benefits to Employee hereunder
shall cease and Employee shall be entitled to (a) payment of (1) any accrued but unpaid salary and unused vacation as of the date of such termination as
required by California law, which shall be due and payable upon the effective date of such termination, and (2) an amount, which shall be due and payable
within ten days following the effective date of such termination, equal to six months’ salary as provided in Section 5.1, and (b) continued participation, at
Employer’s cost and expense, for a period of six months following such termination, in any Employer-sponsored group benefit plans in which Employee was
participating as of the date of termination, provided that, as a condition to Employer’s obligations under Section 6.2(a)(2) and 6.2(b), Employee shall have
executed and delivered to Employer a Separation Agreement and General Release in the form attached hereto as Exhibit A.
6.3. Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice
from Employer in event of his permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of
disability insurance maintained by Employer (or by Employee, as the case may be) with respect to Employee or, if no such policy is then in effect, shall mean
Employee’s inability to fully perform his duties hereunder for any period of at least 75 consecutive days or for a total of 90 days, whether or not
consecutive. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employer shall
pay to the Employee’s heirs or personal representatives, not later than ten days after the date of termination, any accrued but unpaid salary and unused
vacation as of the date of such termination as required by California law.
7. Confidentiality. While this Agreement is in effect and for a period of five years thereafter, Employee shall hold and keep secret and
confidential all “trade secrets” (within the meaning of applicable law) and other confidential or proprietary information of Employer and shall use such
information only in the course of performing Employee’s duties hereunder; provided, however, that with respect to trade secrets, Employee shall hold and
keep secret and confidential such trade secrets for so long as they remain trade secrets under applicable law. Employee shall maintain in trust all such trade
secrets or other confidential or proprietary information, as Employer’s property, including, but not limited to, all documents concerning Employer’s business,
including Employee’s work papers, telephone directories, customer information and notes, and any and all copies thereof in Employee’s possession or under
Employee’s control. Upon the expiration or earlier termination of Employee’s employment with Employer, or upon request by Employer, Employee shall
deliver to Employer all such documents belonging to Employer, including any and all copies in Employee’s possession or under Employee’s control.
8. Equitable Remedies; Injunctive Relief. Employee hereby acknowledges and agrees that monetary damages are inadequate to fully
compensate Employer for the damages that would result from a breach or threatened breach of Section 7 of this Agreement and, accordingly, that Employer
shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and
permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. This provision shall not, however,
diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
9. Indemnification; Insurance. Employer and Employee acknowledge that, as the Chief Financial Officer of the Employer, Employee shall
be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent provided by Employer to its officers, directors
and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement. Employer shall maintain Employee as
an additional insured under its current policy of directors and officers liability insurance and shall use commercially reasonable efforts to continue to insure
Employee thereunder, or under any replacement policies in effect from time to time, during the Term.
10. Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or
otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless
be binding and enforceable.
11. Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon Employer, its successors and assigns and
Employee and his heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other
party.
12. Entire Agreement. This Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties
hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise herein. This
Agreement supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter
hereof. Any such prior or contemporaneous agreements are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that
any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement.
13. Amendment. No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto and unless such
writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this
Agreement be enforceable or valid.
14. Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without
giving effect to California’s choice-of-law rules.
15. Notice. All notices and other communications under this Agreement shall be in writing and mailed, telecopied (in case of notice to
Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to
such other address as such party may have specified by notice given to the other party pursuant to this provision):
If to Employer:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Facsimile: (310) 826-5529
Attention: Chief Executive Officer
If to Employee:
__________________
__________________
__________________
16. Survival. Sections 7 through 16 and 19 shall survive the expiration or termination of this Agreement.
17. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same agreement. A counterpart executed and transmitted by facsimile shall have the same force and effect as an
originally executed counterpart.
18. Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled
to recover its or his reasonable attorneys’ fees and other costs of suit (up to a maximum of $15,000) in addition to any other recoveries.
19. No Interpretation of Ambiguities Against Drafting Party. This Agreement has been negotiated at arm's length between persons
knowledgeable in the matters dealt with herein. In addition, each party has been represented by experienced and knowledgeable legal counsel. Accordingly,
the parties agree that any rule of law, including, but not limited to, California Civil Code Section 1654 or any other statutes, legal decisions, or common law
principles of similar effect, that would require interpretation of any ambiguities in this Agreement against the party that has drafted it, is of no application and
is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties hereto.
IN WITNESS WHEREOF, this Agreement is executed as of the day and year first above written.
“EMPLOYER”
CytRx Corporation
By: /s/ STEVEN A.
KRIEGSMAN
Steven A. Kriegsman
President and Chief Executive Officer
“EMPLOYEE”
/s/ JOHN CALOZ
John Caloz
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
EXHIBIT 23.1
CytRx Corporation
Los Angeles, California
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-100947, 333-109708, 333-106629, 333-109708,
333-133269, 333-142591, 333-147605 and 333-170437) and Form S-8 (Nos. 333-84657, 333-68200, 333-91068, 333-93305, 333-123339 and 333-163212) of
CytRx Corporation of our reports dated March 11, 2011, relating to the consolidated financial statements and schedule and the effectiveness of CytRx
Corporation’s internal control over financial reporting, which appear in this Form 10-K.
/s/ BDO USA, LLP
Los Angeles, California
March 11, 2011
Exhibit 31.1
I, Steven A. Kriegsman, Chief Executive Officer of CytRx Corporation, certify that:
1. I have reviewed this annual report on Form 10-K of CytRx Corporation;
CERTIFICATIONS
2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this
annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this annual report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 11, 2011
By: /s/ STEVEN A. KRIEGSMAN
Steven A. Kriegsman
Chief Executive Officer
Exhibit 31.2
I, John Y. Caloz, Chief Financial Officer of CytRx Corporation, certify that:
1. I have reviewed this annual report on Form 10-K of CytRx Corporation;
CERTIFICATIONS
2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this
annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this annual report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 11, 2011
By: /s/ JOHN Y. CALOZ
John Y. Caloz
Chief Financial Officer
Certification of Chief Executive Officer
Exhibit 32.1
Pursuant to 18 U.S.C. 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the “Company”)
hereby certifies that:
(i) the accompanying Annual Report on Form 10-K of the Company for the year ended December 31, 2010 (the “Report”) fully complies with the
requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 11, 2011
By: /s/ STEVEN A. KRIEGSMAN
Steven A. Kriegsman
Chief Executive Officer
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document authenticating,
acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906,
has been provided to CytRx Corporation and will be retained by CytRx Corporation and furnished to the Securities and Exchange Commission or its staff
upon request.
The foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-K and shall not be considered filed as
part of the Form 10-K.
Certification of Chief Financial Officer
Exhibit 32.2
Pursuant to 18 U.S.C. 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of CytRx Corporation (the “Company”)
hereby certifies that:
(i) the accompanying Annual Report on Form 10-K of the Company for the year ended December 31, 2010 (the “Report”) fully complies with the
requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 11, 2011
By: /s/ JOHN Y. CALOZ
John Y. Caloz
Chief Financial Officer
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document authenticating,
acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906,
has been provided to CytRx Corporation and will be retained by CytRx Corporation and furnished to the Securities and Exchange Commission or its staff
upon request.
The foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-K and shall not be considered filed as
part of the Form 10-K.