EntreMed Reports Fourth Quarter And Year-End 2012 Financial Results And Business Outlook For 2013

Thu Mar 21, 2013 7:00am EDT

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ROCKVILLE, Md.,  March 21, 2013  /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD),
a clinical-stage pharmaceutical company developing therapeutics for the
treatment of cancer, today reported results for the three months and twelve
months ended  December 31, 2012.   

(Logo:  http://photos.prnewswire.com/prnh/20010620/ENMDLOGO  )

The Company reported a net loss of ($0.4 million), or  ($0.02)  per share for
the three months ended  December 31, 2012.  This compares with net income of 
$1.0 million, or  $0.06  per share for the fourth quarter 2011.  The increase in
net loss is directly attributed to the decrease in revenues from royalties
earned from Celgene Corporation's sales of Thalomid®  in the fourth quarter of
fiscal 2012 compared to fiscal 2011.  

For the year ended  December 31, 2012  the net loss, excluding non-cash interest
expense, was ($4.5 million), or  ($0.25)  per share as compared to ($4.6
million), or  ($0.47)  per share for 2011. The reported net loss for the year
ended  December 31, 2012  included non-cash interest charges totaling  $10.0
million  associated with the Company's 2012 financing, recorded in accordance
with US generally accepted accounting principles. Including the non-cash
interest expense, the reported net loss for the year ended  December 31, 2012 
was ($14.5 million), or  ($0.78)  per share.

As of  December 31, 2012, EntreMed had cash and cash equivalents of
approximately  $8.0 million.  The cash position has since been strengthened by
approximately  $10.3 million  in net proceeds from a financing which was
completed on  March 14, 2013.   

Sara B. Capitelli, Vice President, Finance and Principal Accounting Officer,
commented, "Our financial results for the fourth quarter are in line with our
expectations. Our research and development expenses for the fourth quarter
increased compared to the previous year as we began operations in  China  in
2012 and also initiated a dual-institutional Phase 2 study of ENMD-2076 in
triple-negative breast cancer.  We anticipate operating expenses to increase in
2013 as we execute on our clinical development plan in the US and China. 
Royalty revenues from Celgene's sales of Thalomid®  in 2012 were  $0.7 million,
compared to  $1.9 million  in 2011.  The decrease in royalty revenues was in
line with our expectations and results from a decline in sales of Thalomid®  in 
the United States."  Further up-to-date information regarding the Company,
including our Annual Report on Form 10-K for the fiscal year ended  December 31,
2012, can be found on our web site at  www.entremed.com.  

Dr.  Ken Ren, Chief Executive Officer, commented, "We are pleased with our
financial results for the year and quarter ended  December 31, 2012, which
reflect our success in reducing operating costs and at the same time reflect new
costs for implementing new programs, including initiating our Phase 2
triple-negative breast trial at two US sites, establishing our office in 
Beijing, initiating local manufacturing activities in  China, and the filing of
a new clinical trial application with the Chinese SFDA.  Since the year ended,
we also initiated a Phase 2 clinical trial in advanced metastatic soft tissue
sarcoma at Princess Margaret Hospital in Canada.  We are pleased with our recent
financing and the support and encouragement from new institutional shareholders
from both the US and China.  We intend to use the proceeds to further the global
clinical development of ENMD-2076 and for general business development and
corporate purposes."

Dr. Ren continued, "In terms of our outlook for 2013, we remain focused on
building a leading oncology enterprise that integrates US and  China  strategies
and resources for cost effective drug development. We intend to achieve the
following objectives:

* Continue the development of ENMD-2076, including initiating global clinical
trials with sites in  China  under our U.S. FDA IND, and in parallel, pursuing
local development in  China  under SFDA;  
* Pursue an additional clinical-stage drug candidate to add to our pipeline;  
* Further develop our regulatory and clinical capability in  China.

With the foundation established through our achievements in 2012 and our recent
financing, we believe that we are well positioned to accomplish these objectives
and look forward to continued progress in 2013."   

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company employing a drug
development strategy primarily in  the United States  and  China  to develop
targeted therapeutics for the global market.  Its lead compound, ENMD-2076, a
selective angiogenic kinase inhibitor, has completed several Phase 1 studies in
solid tumors, multiple myeloma, and leukemia, and is currently completing a
multi-center Phase 2 study in ovarian cancer.  EntreMed, Inc. recently announced
the initiation of a Phase 2 study of ENMD-2076 in triple-negative breast cancer
and the initiation of a Phase 2 study of ENMD-2076 in advanced/metastatic soft
tissue sarcoma.  Additional information about EntreMed is available on the
Company's web site at  www.entremed.com  and in various filings with the
Securities and Exchange Commission (the SEC).

About ENMD-2076

ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a
unique kinase selectivity profile and multiple mechanisms of action.  ENMD-2076
has been shown to inhibit a distinct profile of angiogenic tyrosine kinase
targets in addition to the Aurora A kinase.  Aurora kinases are key regulators
of mitosis (cell division), and are often over-expressed in human cancers. 
ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases which have been shown
to play important roles in the pathology of several cancers.  ENMD-2076 has
shown promising activity in Phase 1 clinical trials in solid tumor cancers,
leukemia, and multiple myeloma.  ENMD-2076 is currently completing a Phase 2
trial for ovarian cancer.  EntreMed, Inc. recently initiated a
dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer.

Forward Looking Statements             

This release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act with respect to the outlook for
expectations for future financial or business performance, strategies,
expectations and goals.  Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time. Forward-looking
statements speak only as of the date they are made, and no duty to update
forward-looking statements is assumed.

Actual results could differ materially from those currently anticipated due to a
number of factors, including: the risk that we may be unable to continue as a
going concern as a result of our inability to raise sufficient capital for our
operational needs; the possibility that we may be delisted from trading on the
Nasdaq Capital Market; the volatility of our common stock; the difficulty of
executing our business strategy in  China; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing and
distribution of our proposed product candidate; risks relating to the need for
additional capital and the uncertainty of securing additional funding on
favorable terms; declines in actual sales of Thalomid resulting in reduced
royalty payments; risks associated with our product candidates; any early-stage
products under development; results in preclinical models are not necessarily
indicative of clinical results; uncertainties relating to preclinical and
clinical trials, including delays to the commencement of such trials; the lack
of success in the clinical development of any of our products; dependence on
third parties; and risks relating to the commercialization, if any, of our
proposed products (such as marketing, safety, regulatory, patent, product
liability, supply, competition and other risks).  Such factors, among others,
could have a material adverse effect upon our business, results of operations
and financial condition.  We caution readers not to place undue reliance on any
forward-looking statements, which only speak as of the date made. Additional
information about the factors and risks that could affect our business,
financial condition and results of operations, are contained in our filings with
the U.S. Securities and Exchange Commission ("SEC"), which are available at 
www.sec.gov.  

 

COMPANY CONTACT:

Investor Relations
EntreMed, Inc.
240.864.2643
investorrelations@entremed.com

(Financial Table Attached)

 ENTREMED, INC.                                                                               
 SUMMARY OF OPERATING RESULTS                                                                 
 Three Months Ended                                                                           
 December 31,                                                                                 
                                                                                            
                                                        2012              2011              
 Total revenues                                         $   669,310       $1,932,035        
                                                                                            
 Research and development                               $   494,712       $   405,936       
                                                                                            
 General and administrative                             $   535,096       $   521,906       
                                                                                            
 Net (loss) income                                      $ (360,430)       $1,004,522        
                                                                                            
 Dividend on Series A convertible preferred stock       -                 $ (251,250)       
                                                                                            
 Net (loss) income attributable to common shareholders  $ (360,430)       $   753,272       
                                                                                            
 Net (loss) income per share attributable to            $       (0.02)    $         0.06    
 common shareholders (basic and diluted)                                                    
                                                                                            
 Weighted average number of                             22,503,393        12,158,099        
 shares outstanding (basic and diluted)                                                     
                                                                                            
                                                                                            
 Twelve Months Ended                                                                          
 December 31,                                                                                 
                                                                                            
                                                        2012              2011              
 Total revenues                                         $     669,310     $  1,940,887      
                                                        
 Research and development                               $  2,375,339      $  3,457,373      
                                                        
 General and administrative                             $  2,797,971      $  3,051,511      
                                                        
 Interest expense, net                                  $10,041,224       -                 
                                                        
 Net loss                                               $(14,545,224)     $(4,558,495)      
                                                        
 Dividend on Series A convertible preferred stock       $   (335,000)     $(1,005,000)      
                                                        
 Net loss attributable to common shareholders           $(14,880,224)     $(5,563,495)      
                                                        
 Net loss per share attributable to                     $         (0.78)  $         (0.47)  
 common shareholders (basic and diluted)                                                    
                                                        
 Weighted average number of                             19,055,064        11,781,119        
 shares outstanding (basic and diluted)                                                     
                                                        
 Cash and Cash Equivalents                              $  8,049,237      $  1,080,630      


SOURCE  EntreMed, Inc.

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