CytRx Reports 2012 Financial Results

  CytRx Reports 2012 Financial Results

           Data from four oncology clinical trials expected in 2013

Preparations underway for an international Phase 3 pivotal clinical trial with
         aldoxorubicin in patients with advanced soft tissue sarcomas

Business Wire

LOS ANGELES -- March 11, 2013

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development
company specializing in oncology, today reported financial results for the 12
months ended December 31, 2012, and provided 2013 milestones for its clinical
development programs.

“This is an inflection year for CytRx as data are expected from four clinical
trials with our highly promising oncology drug compounds that address
significant markets,” said President and Chief Executive Officer Steven A.
Kriegsman. “We also are actively making preparations for a randomized,
comparative, international Phase 3 clinical trial with aldoxorubicin as a
second-line treatment in patients with soft tissue sarcomas. Subject to
agreement from the FDA, we expect to initiate the trial in the second half of
this year. The FDA is currently reviewing our request to conduct this trial
under a special protocol assessment (SPA), which we filed in January.”

By reaching agreement with the FDA on a trial protocol under an SPA, the FDA
deems that a Phase 3 clinical trial is acceptable for support of regulatory
approval, subject to trial results. Favorable results from a Phase 1b/2
clinical trial with aldoxorubicin showed clinical benefit (partial response or
stable disease at four months following treatment) in 77% of evaluable
patients with advanced soft tissue sarcomas who had failed other therapies.
CytRx holds exclusive worldwide rights to aldoxorubicin, the tumor-targeting
conjugate of the commonly used chemotherapeutic agent doxorubicin.

CytRx expects in 2013 to report results from clinical trials with
aldoxorubicin as follows:

  *Second Quarter – Phase 1b clinical trial results from 24 patients with
    advanced solid tumors to determine the maximum tolerated dose (MTD) of a
    combination of aldoxorubicin and doxorubicin. The clinical trial will
    continue with the combination aldoxorubicin and doxorubicin administered
    at the MTD to an expansion group of patients with chondrosarcomas or
    chordomas to determine safety and preliminary efficacy in these normally
    chemotherapy-insensitive malignancies. The purpose of this trial is to
    extend the Company’s patent portfolio and potentially increase market
    penetration with aldoxorubicin for the treatment of patients with solid
    tumors.
  *First Half – Pharmacokinetic results from an open-label, single-center
    Phase 1b clinical trial in patient with metastatic solid tumors.
  *Second Half – Progression-free survival results from an international
    Phase 2b clinical trial in 105 patients comparing aldoxorubicin with
    doxorubicin as a first-line treatment for soft tissue sarcoma. This trial
    is being conducted under the direction of world-renowned expert in soft
    tissue sarcoma treatment Santa P. Chawla, M.S., F.R.A.C.P., Director of
    the Sarcoma Oncology Center in Santa Monica, Calif.

“Additionally, we expect to report topline data in the second half of 2013
from our international Phase 2b clinical trial with tamibarotene in 140
evaluable patients with advanced non-small cell lung cancer (NSCLC),” added
Mr. Kriegsman. “Lung cancer is the leading cause of cancer deaths around the
world and is more deadly than colon, breast and prostate cancers combined. We
believe that tamibarotene could be a breakthrough treatment for NSCLC. This is
a major opportunity for CytRx with the NSCLC therapy market projected to reach
$13.3 billion by 2015.

“We have a strong balance sheet to support the advancement of our robust
development pipeline with 2012 year end cash and equivalents of more than $38
million and no debt.”

Full Year 2012 Financial Results

Net loss for the year ended December 31, 2012 was $18.0 million, or $0.78 per
share, compared with a net loss of $14.4 million, or $0.80 per share, for the
year ended December 31, 2011. In 2012 and 2011, the Company recognized
non-cash gains of $2.8 million and $7.9 million, respectively, on the
valuation of warrant derivative liabilities related to warrants issued in
August 2011 and July 2009.  The Company reported licensing revenue of $100,000
for 2012, compared with $250,000 for 2011.

Research and development (R&D) expenses were $12.7 million for 2012, and
included development expenses of $6.6 million for aldoxorubicin and $3.1
million for tamibarotene. R&D expenses were $15.5 million for 2011.

General and administrative (G&A) expenses were $8.4 million for 2012, compared
with $7.3 million for 2011. G&A expenses included non-cash stock-compensation
expense of $2.0 million and $1.0 million for 2012 and 2011, respectively.

CytRx reported cash, cash equivalents and short-term investments of $38.3
million as of December 31, 2012, which included $21.5 million of net proceeds
from an underwritten public offering completed on October 23, 2012.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company
specializing in oncology. The CytRx oncology pipeline includes two programs in
clinical development for cancer indications: aldoxorubicin (formerly known as
INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate
aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as
a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical
trial primarily in the same indication, and has initiated a Phase 1b
pharmacokinetics clinical trial in patients with metastatic solid tumors and a
Phase 1b study of aldoxorubicin in combination with doxorubicin in patients
with advanced solid tumors. The Company has held a positive meeting with the
FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a
therapy for patients with soft tissue sarcomas whose tumors have progressed
following treatment with chemotherapy, and has submitted a special protocol
assessment related to this trial. Tamibarotene is being tested in a
double-blind, placebo-controlled, international Phase 2b clinical trial in
patients with non-small-cell lung cancer. The Company reached its enrollment
target for that trial in February 2013. The Company completed its evaluation
of a third drug candidate, bafetinib, in the ENABLE Phase 2 clinical trial in
high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a
partner for further development of bafetinib. For more information aboutCytRx
Corporation, visitwww.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 or uncertainties related to the
outcome, timing and results of CytRx's clinical trials with aldoxorubicin and
tamibarotene, the risk that any future human testing of aldoxorubicin or
tamibarotene might not produce results similar to those seen in the Company's
prior animal or human trials, uncertainties regarding regulatory approvals for
current and future clinical testing, including CytRx's planned Phase 3
clinical trial for aldoxorubicin, and the scope of the clinical testing that
may eventually be required by regulatory authorities, the risk that
aldoxorubicin might not show greater efficacy than doxorubicin notwithstanding
the administration of higher doses than the standard of care, the risk that
additional longer-term dosing of aldoxorubicin might cause adverse events not
seen to date in CytRx's Phase 1b/2 trial, uncertainties regarding whether
aldoxorubicin effectively targets doxorubicin to tumors, the significant time
and expense that will be incurred in developing any of the potential
commercial applications for aldoxorubicin or tamibarotene, 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, 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

                                    December 31,
                                       2012                2011
ASSETS
Current assets:
Cash and cash equivalents              $ 14,344,088           $ 17,988,590
Short-term investments                   24,000,000             18,057,672
Receivables                              109,802                175,704
Interest receivable                      26,517                 41,275
Prepaid expenses and other              1,212,041            1,017,799    
current assets
Total current assets                     39,692,448             37,281,040
Equipment and furnishings, net           253,277                266,335
Goodwill                                 183,780                183,780
Other assets                            102,271              123,268      
Total assets                           $ 40,231,776          $ 37,854,423   
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable                       $ 3,060,516            $ 2,074,463
Accrued expenses and other               3,033,189              4,786,956
current liabilities
Warrant liabilities                     3,972,230            6,738,934    
Total current liabilities               10,065,935           13,600,353   
Commitment 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;
30,607,916 and
21,302,327 shares issued and             30,608                 21,303
outstanding at December 31, 2012
and 2011,
respectively
Additional paid-in capital               261,318,638            237,452,299
Treasury stock, at cost (90,546          (2,279,238   )         (2,279,238   )
shares)
Accumulated deficit                     (228,904,167 )        (210,940,294 )
Total stockholders’ equity              30,165,841           24,254,070   
Total liabilities and                  $ 40,231,776          $ 37,854,423   
stockholders’ equity
                                                                             


CYTRX CORPORATION
CONDENSED STATEMENTS OF OPERATIONS

                  Years Ended December 31,
                     2012               2011               2010
Revenue:
Licensing            $ 100,000            $ 250,000            $ 100,000     
revenue
                                                                 
Expenses:
Research and           12,684,793            15,491,301            8,506,937
development
General and            8,353,330             7,317,169             8,235,993
administrative
Depreciation
and                   113,936             95,517              107,666     
amortization
                      21,152,059          22,903,987          16,850,596  
Loss before            (21,052,059 )         (22,653,987 )         (16,750,596 )
other income
                                                                               
Other income:
Interest               131,666               207,217               303,592
income
Other income,          191,416               205,194               95,827
net
Gain on
warrant                2,766,704             7,915,027             933,420
liability
Gain on sale
of affiliate’s        —                   —                   15,826,217  
shares - RXi
Pharmaceutical
                                                                 
Net (loss)
income before          (17,962,273 )         (14,326,549 )         408,460
provision for
income taxes
Income tax            (1,600      )        (97,996     )        —           
expense
Net (loss)           $ (17,963,873 )       $ (14,424,545 )       $ 408,460     
income
                                                                               
Basic and
diluted (loss)       $ (0.78       )       $ (0.80       )       $ 0.03        
income per
share
Basic weighted
average shares        22,973,905          17,935,895          15,640,642  
outstanding
Diluted
weighted              22,973,905          17,935,895          15,920,326  
average shares
outstanding

Contact:

Investor Relations:
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
 
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