EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

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PRESS RELEASE

 

Company Contact:    Investor Contact:   
Roger G. Stoll, Ph.D.    Erika Moran/ Dian Griesel, Ph.D.   
Chairman, President and CEO    The Investor Relations Group   
Cortex Pharmaceuticals, Inc.    212.825.3210   
949.727.3157      

CORTEX REPORTS SECOND QUARTER OPERATING RESULTS

IRVINE, CA (August 9, 2007) — Cortex Pharmaceuticals, Inc. (AMEX: COR) reported a net loss of $2,850,000, or $0.07 per share for the quarter ended June 30, 2007 compared with a net loss of $4,398,000, or $0.13 per share for the corresponding prior year period. Non cash stock-based compensation charges for the quarter ended June 30, 2007 and 2006 were approximately $416,000 and $582,000, respectively.

For the six months ended June 30, 2007, Cortex reported a net loss of $6,734,000, or $0.17 per share compared to a net loss of $8,958,000, or $0.26 per share for the corresponding prior year period. Non cash stock-based compensation charges for the six months ended June 30, 2007 and 2006 were approximately $1,069,000 and $1,876,000, respectively.

Results for the quarter ended June 30, 2007 reflect decreased operating expenses, mostly resulting from reduced contract research expenses for the AMPAKINE® CX717 due to the timing of additional toxicology studies performed in prior periods.

In April 2007, Cortex submitted further data to the FDA that demonstrates that the cellular effects originally interpreted as toxicity occur postmortem and are directly related to the interaction of the cells with the fixative used to prepare tissue samples for analysis. In July 2007, the FDA indicated that Cortex may resume its previously approved clinical trials with CX717 in Alzheimer’s disease at all requested dose levels.

During the third quarter of 2007, the Company intends to file an Investigational New Drug Application for CX717 with the Division of Psychiatry Products of the FDA to allow Cortex to initiate a Phase IIb study with the compound as a treatment for Attention Deficit Hyperactivity Disorder. Prior to the FDA clinical hold on the compound, the Company announced positive statistical and clinical results with CX717 in a Phase IIa trial in adults with that indication.

Operating results for the year-to-date also reflect decreased clinical development expenses, given that the Company had not re-initiated clinical trials of CX717. Non-cash stock compensation charges decreased due to a decrease in stock options granted during the current year and the scheduled vesting of earlier granted options.


Cortex’s cash and marketable securities amounted to $8,675,000 at June 30, 2007, and included net proceeds of approximately $5,100,000 from a registered direct offering of the Company’s common stock and warrants in January 2007. Subsequent to June 30, 2007, the Company received approximately $800,000 from the exercise of previously issued warrants and options to purchase shares of its common stock. Cortex anticipates that its existing cash and marketable securities will support its funding requirements into 2008.

Cortex Pharmaceuticals, Inc.

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease. In December 2006 Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of AMPAKINE compounds in the treatment of neurodegenerative diseases on a global basis. However, Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing AMPAKINE compounds.

Forward-Looking Statement

Note — This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company’s patents or develop competing technologies; and that preclinical or clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly preclinical and clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

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Cortex Pharmaceuticals, Inc.

Condensed Statements of Operations

(in thousands, except per share data)

 

    

Three months ended

June 30,

   

Six months ended

June 30,

 
     2007     2006     2007     2006  
     (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  

Revenues

   $ —       $ 232     $ —       $ 463  

Operating expenses (A):

        

Research and development

     2,010       3,706       5,002       7,171  

General and administrative

     962       1,114       1,997       2,590  
                                

Total operating expenses

     2,972       4,820       6,999       9,761  
                                

Loss from operations

     (2,972 )     (4,588 )     (6,999 )     (9,298 )

Interest income, net

     122       190       265       340  
                                

Net loss

   $ (2,850 )   $ (4,398 )   $ (6,734 )   $ (8,958 )
                                

Loss per share:

        

Basic and diluted

   $ (0.07 )   $ (0.13 )   $ (0.17 )   $ (0.26 )

Shares used in computing per share amounts

        

Basic and diluted

     40,018       34,788       39,149       33,817  

(A) Operating expenses include the following non-cash stock compensation charges:

        

Research and development

   $ 265     $ 344     $ 725     $ 1,086  

General and administrative

     151       238       344       790  
                                
   $ 416     $ 582     $ 1,069     $ 1,876  
                                

Cortex Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)

 

     June 30,
2007
   December 31,
2006

Assets:

     

Cash and cash equivalents

   $ 2,090    $ 1,650

Marketable securities

     6,585      7,799

Other current assets

     378      525
             
     9,053      9,974

Furniture, equipment and leasehold improvements, net

     431      428

Other

     33      33
             

Total assets

   $ 9,517    $ 10,435
             

Liabilities and Stockholders’ Equity:

     

Accounts payable and accrued expenses

   $ 1,686    $ 2,056

Deferred rent liability

     44      58

Stockholders’ equity

     7,787      8,321
             

Total liabilities and stockholders’ equity

   $ 9,517    $ 10,435
             

MORE INFORMATION AT WWW.CORTEXPHARM.COM

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