CytRx Reports 2013 Second Quarter Financial Results

  CytRx Reports 2013 Second Quarter Financial Results

 Plans to initiate Phase 2b trial in brain cancer in the second half of 2013
 and global Phase 3 pivotal trial in soft tissue sarcoma in the first quarter
                                   of 2014

Business Wire

LOS ANGELES -- August 6, 2013

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today reported financial results for the
three and six months ended June 30, 2013, and provided a clinical update.

“This is a pivotal time at CytRx with multiple near-term significant clinical
results,” said Steven A. Kriegsman, CytRx President and CEO. “We are making
preparations to begin in the coming months two late-stage clinical trials with
aldoxorubicin, our improved version of the widely used chemotherapeutic
doxorubicin, and expect to report data in the second half of 2013 from our
global Phase 2b clinical trial testing aldoxorubicin head-to-head against
doxorubicin as a first-line therapy for soft tissue sarcomas.”

“We plan to initiate a Phase 2b clinical trial later this year in patients
with advanced, relapsed glioblastoma (brain cancer), following exciting,
statistically significant efficacy data that we reported in July showing that
aldoxorubicin induced tumor regression and significantly increased the
lifespan of animals with intracranial implanted human glioblastoma,” said Mr.
Kriegsman. “Our decision to rapidly move into the clinic was prompted by
aldoxorubicin’s demonstrated ability to cross the blood-brain barrier and
concentrate at the site of glioblastoma tumors. Effective treatment of
glioblastoma is a major unmet medical need, and there is no therapy that
prolongs life for this difficult-to-treat, deadly cancer after it relapses.

“Our global pivotal Phase 3 trial is expected to commence in the first quarter
of 2014. This clinical trial will evaluate aldoxorubicin as a treatment for
patients with soft tissue sarcomas which have progressed following prior
treatment with chemotherapy. The Phase 3 pivotal trial is being conducted
under a special protocol assessment (SPA) with progression free survival as
the primary endpoint,” he added.

Recent Clinical Highlights

  *In May - announced initial data from a Phase 1b clinical trial
    demonstrating that aldoxorubucin has distribution half-life of 20-24 hours
    following infusion, which is significantly longer than the five minute
    half-life of doxorubicin. The trial also indicated that aldoxorubicin’s
    distribution to healthy tissue was 250-fold less than that of doxorubicin.
    Aldoxorubicin showed prolonged clinical activity in two patients with
    small-cell lung cancer who had failed other therapies.
  *In June - presented preliminary results from a Phase 1b clinical trial
    that showed that aldoxorubicin administered at 90% of its single agent
    dose could safely be delivered in combination with doxorubicin at 50% of
    its single agent dose to patients with advanced solid tumors. The
    presentation was made at the American Society of Clinical Oncology (ASCO)
    conference.
  *In June - announced the completion of enrollment of 105 evaluable patients
    in the global Phase 2b clinical trial with aldoxorubicin as a first-line
    treatment for soft tissue sarcoma. This clinical trial allows for a
    head-to-head evaluation of efficacy and safety of aldoxorubicin and
    doxorubicin.
  *In July - reported highly favorable data from a confirmatory preclinical
    trial of human glioblastoma that showed statistically significant efficacy
    of arimoclomol (prolonged survival) and highly specific uptake of drug in
    the tumor only and not normal brain tissue.

Upcoming Milestones

  *2H13 – initiation of Phase 2b clinical trial with aldoxorubicin in
    patients with relapsed glioblastoma.
  *2H13 – progression free survival and tumor response results from the
    global Phase 2b clinical trial directly comparing the efficacy and safety
    of aldoxorubicin and doxorubicin as a first-line treatment for patients
    with soft tissue sarcoma.
  *1Q14 – initiation of global Phase 3 pivotal clinical trial with
    aldoxorubicin as a second-line treatment for patients with soft tissue
    sarcoma who have failed chemotherapy.
  *Ongoing work in expanding the oncology pipeline by combining the novel
    linker platform technology with additional chemotherapeutic agents.

Second Quarter 2013 Financial Results

Net loss for the three months ended June 30, 2013 was $3.4 million, or $0.11
per share, compared with a net loss of $13.3 million, or $0.63 per share, for
the three months ended June 30, 2012. In the second quarter of 2013, the
Company recognized a non-cash gain of $2.9 million on warrant derivative
liability, compared with a loss on warrant derivative liability of $8.5
million for the second quarter of 2012. The Company reported license revenue
of $200,000 for the second quarter of 2013 and did not recognize revenue for
the second of 2012.

Research and development (R&D) expenses were $4.6 million for the second
quarter of 2013, and included development expenses of $2.5 million for
aldoxorubicin and $0.9 million for tamibarotene. R&D expenses were $2.7
million for the second quarter of 2012.

General and administrative (G&A) expenses were $2.0 million and $2.1 million
for three months ended June 30, 2013 and 2012, with non-cash
stock-compensation expense of $0.4 million recorded for both quarters.

CytRx reported cash, cash equivalents and short-term investments of $28.0
million and no debt as of June 30, 2013.

About Glioblastoma

Glioblastoma is the most common and most malignant brain tumor in adults and
afflicts more than 12,500 new patients in the U.S. annually. Despite surgical
resection, radiotherapy and chemotherapy, the median survival after diagnosis
is about 12-14 months. Although the reason for treatment failure may depend
upon several factors, limited efficacy of chemotherapeutic agents has been
attributed to several contributing factors including insufficient drug
delivery to the tumor site through the blood-brain barrier.

About Soft Tissue Sarcoma

Sarcoma is an umbrella term for more than 50 subtypes of cancer that occur in
the muscles, fat, blood vessels, tendons and other connective tissues in the
body. Last year an estimated 38,000 new cases of soft tissue sarcoma were
reported and more than 13,000 deaths were attributed to this cancer in the
U.S. and Europe. Patients with metastatic, locally advanced or unresectable
soft tissue sarcomas have a poor prognosis with progression-free survival of
around 2 months to 4.6 months and median overall survival of approximately 9
months to 12 months. CytRx has been granted orphan drug designation by the FDA
for the treatment of patients with soft tissue sarcomas.

AboutCytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company
specializing in oncology. The CytRx oncology pipeline is focused on the
clinical development of aldoxorubicin (formerly known as INNO-206), its
improved version of the widely used chemotherapeutic agent doxorubicin. CytRx
has initiated a global Phase 2b clinical trial with aldoxorubicin as a
treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical
trial primarily in the same indication and a Phase 1b study of aldoxorubicin
in combination with doxorubicin in patients with advanced solid tumors, and is
conducting a Phase 1b pharmacokinetics clinical trial in patients with
metastatic solid tumors. The Company plans to initiate a Phase 3 global
pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as
a therapy for patients with soft tissue sarcomas whose tumors have progressed
following treatment with chemotherapy. CytRx also is initiating a Phase 2b
clinical trial with aldoxorubicin in patients with late-stage glioblastoma
(brain cancer). CytRx is expanding its pipeline of oncology candidates based
on a novel linker platform technology that can be utilized with multiple
chemotherapeutic agents and could allow for greater concentration of drug at
tumor sites. The Company also has rights to two additional drug candidates,
tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the
ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia
(B-CLL), plans to seek a partner for further development of bafetinib, and is
evaluating further development of tamibarotene. For more information about
CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended. Such
statements involve risks and uncertainties that could cause actual events or
results to differ materially from the events or results described in the
forward-looking statements, including risks relating to the outcome, timing
and results of CytRx's clinical trials, the risk that any future human testing
of aldoxorubicin, the Company’s linker technology and other drug candidates
might not produce results similar to those seen in past human or animal
testing, risks related to CytRx's ability to manufacture its drug candidates
in a timely fashion, cost-effectively or in commercial quantities in
compliance with stringent regulatory requirements, risks related to CytRx's
need for additional capital or strategic partnerships to fund its ongoing
working capital needs and development efforts, including the Phase 3 clinical
development of aldoxorubicin, and the risks and uncertainties described in the
most recent annual and quarterly reports filed by CytRx with the Securities
and Exchange Commission and current reports filed since the date of CytRx's
most recent annual report. All forward-looking statements are based upon
information available to CytRx on the date the statements are first published.
CytRx undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.

CYTRX CORPORATION

CONDENSED BALANCE SHEETS

(Unaudited)
                                                           
                                          June 30, 2013      December 31, 2012
ASSETS
Current assets:
Cash and cash equivalents                 $ 10,980,486       $  14,344,088
Short-term investments                      17,000,000          24,000,000
Receivables                                 211,626             109,802
Interest receivable                         56,451              26,517
Prepaid expenses and other current assets  580,904           1,212,041    
Total current assets                        28,829,467          39,692,448
Equipment and furnishings, net              199,580             253,277
Goodwill                                    183,780             183,780
Other assets                               102,271           102,271      
Total assets                              $ 29,315,098      $  40,231,776   
LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
                                          $ 2,783,894        $  3,060,516
Accounts payable
Accrued expenses and other current          2,811,770           3,033,189
liabilities
Warrant liabilities                        3,133,743         3,972,230    
Total current liabilities                  8,729,407         10,065,935   
                                                             
Commitments and contingencies
                                                             
Stockholders’ equity
Preferred Stock, $.01 par value,
5,000,000 shares authorized, including
25,000 shares of Series A Junior            —                   —
Participating Preferred Stock; no shares
issued and outstanding
Common stock, $.001 par value,
250,000,000 shares authorized; 30,608,392   30,609              30,608
shares issued and outstanding at June 30,
2013 and 30,607,916 at December 31, 2012
Additional paid-in capital                  262,082,318         261,318,638
Treasury stock, at cost (118,836 shares
at June 30, 2013 and 90,546 at December     (2,335,818   )      (2,279,238   )
31, 2012)
Accumulated deficit                        (239,191,418 )     (228,904,167 )
Total stockholders’ equity                 20,585,691        30,165,841   
Total liabilities and stockholders’       $ 29,315,098      $  40,231,776   
equity
                                                                             

CYTRX CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)
                                                 
                 Three Months Ended                 Six Months Ended

                 June 30,                           June 30,
                  2013          2012            2013           2012        
Revenue:
License          $ 200,000       $ —              $ 200,000        $ —           
revenue
                                                                      
Expenses:
Research and       4,626,244        2,686,465         7,815,003         7,087,980
development
General and       1,970,930      2,091,856       3,788,255       4,006,572   
administrative
                  6,597,174      4,778,321       11,603,258      11,094,552  
                                                                      
Loss before
other income       (6,397,174 )     (4,778,321  )     (11,403,258 )     (11,094,552 )
(loss)
                                                                      
Other income
(loss):
Interest           35,564           27,547            75,822            63,005
income
Other income,      4,761            16,491            201,698           50,551
net
Gain (loss) on
warrant           2,933,707      (8,528,192  )    838,48          (12,416,358 )
derivative
liability
                                                                      
Net loss         $ (3,423,142 )   $ (13,262,475 )   $ (10,287,251 )   $ (23,397,354 )
                                                                      
Basic and
diluted net      $ (0.11      )   $ (0.63       )   $ (0.34       )   $ (1.10       )
loss per share
                                                                      
Basic and
diluted
weighted          30,418,435     21,204,499      30,417,906      21,203,754  
average shares
outstanding

Contact:

Investor Relations:
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
or
Company
CytRx Corporation
David Haen
Vice President, Business Development
310-826-5648 x304
dhaen@cytrx.com