-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BVnSJ/X/5RpIVaNMZARrExuoOvi3r7cLyFHwJQlEqCqbdhC2PuUlc5G1LgKsmn0D rL2FjmuD7EbuUcg3dwpXmA== 0001193125-08-058724.txt : 20080317 0001193125-08-058724.hdr.sgml : 20080317 20080317151119 ACCESSION NUMBER: 0001193125-08-058724 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080317 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080317 DATE AS OF CHANGE: 20080317 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CORTEX PHARMACEUTICALS INC/DE/ CENTRAL INDEX KEY: 0000849636 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330303583 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-16467 FILM NUMBER: 08692584 BUSINESS ADDRESS: STREET 1: 15241 BARRANCA PKWY CITY: IRVINE STATE: CA ZIP: 92718 BUSINESS PHONE: 7147273157 MAIL ADDRESS: STREET 1: 15241 BARRANCA PARKWAY CITY: IRVINE STATE: CA ZIP: 92718 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

March 17, 2008

CORTEX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   1-16467   33-0303583
(State or other jurisdiction of
incorporation)
  (Commission File Number)   (I.R.S Employer Identification No.)

 

15241 Barranca Parkway

Irvine, California

  92618
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (949) 727-3157

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On March 17, 2008, Cortex Pharmaceuticals, Inc. issued a press release to report its financial results. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the foregoing information, including Exhibit 99.1, is being furnished under Item 2.02 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

  (a) Financial Statements of Businesses Acquired: None.

 

  (b) Pro Forma Financial Information: None.

 

  (c) Shell Company Transactions: None.

 

  (d) Exhibits.

 

Exhibit
Number

  

Description

99.1    Press release of Cortex Pharmaceuticals, Inc. dated March 17, 2008.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CORTEX PHARMACEUTICALS, INC.
Date:   March 17, 2008     By:   /s/ Maria S. Messinger
        Maria S. Messinger
       

Vice President, Chief Financial Officer

and Corporate Secretary


EXHIBIT INDEX

 

Exhibit

Number

  

Description

   Sequential
Page No.
99.1    Press release of Cortex Pharmaceuticals, Inc. dated March 17, 2008.    5
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

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 FOURTH QUARTER AND

YEAR END OPERATING RESULTS

IRVINE, CA (March 17, 2008) — Cortex Pharmaceuticals, Inc. (AMEX: COR, http://www.cortexpharm.com) reported a net loss of $3,273,000, or $0.07 per share for the quarter ended December 31, 2007 compared with a net loss of $3,462,000, or $0.10 per share for the corresponding prior year period. Non-cash stock-based compensation charges for the quarters ended December 31, 2007 and 2006 totaled approximately $533,000 and $625,000, respectively.

For the fiscal year ended December 31, 2007, Cortex reported a net loss of $12,969,000, or $0.31 per share compared to a net loss of $16,055,000, or $0.47 per share for the corresponding prior year period. Non-cash stock-based compensation charges for the years ended December 31, 2007 and 2006 approximated $2,237,000 and $3,231,000, respectively, with the decrease due to a decrease in stock options granted during 2007 relative to 2006, and the vesting schedules for outstanding options.

Year-to-date operating results reflect decreased preclinical and clinical development expenses given that Cortex only recently was able to re-activate some of its clinical activities. The company’s development plans for 2008 include two Phase IIa human clinical studies of AMPAKINE® CX717 as a potential acute treatment for respiratory depression.

As recently reported, Cortex has received approval from the German regulatory authority to proceed with both of these clinical trials. One study will evaluate whether the pre-administration of CX717 may prevent the respiratory depression induced by the opiate alfentanil, while preserving alfentanil’s pain relieving effects. A second study will seek to determine the optimal dose of CX717 in order to prevent respiratory depression. Related results from these studies are anticipated in late second quarter and early third quarter of 2008.

Cortex believes that CX717 may improve the safety margin for giving powerful pain relievers following surgical procedures, and thereby provide a valuable tool for anesthesiologists and surgeons to optimize pain management in their patients.

Studies of CX717 in animal models have demonstrated that the drug can be used both to prevent and to rescue the animal from opiate-induced respiratory depression. It also has been shown that a dose response effect on respiratory depression can be obtained after oral administration in animal models.


Cortex recently re-initiated its Phase IIa PET imaging studies with CX717 in Alzheimer’s disease. During 2008, Cortex also anticipates entering into Phase I human clinical trials with CX1739, a follow-on compound. Necessary toxicology studies for this compound are already underway and expected to be completed in June 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 Schering-Plough (formerly N.V. Organon) for the treatment of schizophrenia and depression 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 rights 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 Schering-Plough 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.

(tables follow)


Cortex Pharmaceuticals, Inc.

Condensed Statements of Operations

(in thousands, except per share data)

 

     Three months ended
December 31,
    Fiscal year ended
December 31,
 
     2007     2006     2007     2006  
     (Unaudited)     (Unaudited)              

Revenues

   $ —       $ 313     $ —  $       1,177  

Operating expenses (A):

        

Research and development

     2,384       2,899       9,327       13,262  

General and administrative

     1,141       1,012       4,320       4,616  
                                

Total operating expenses

     3,525       3,911       13,647       17,878  
                                

Loss from operations

     (3,525 )     (3,598 )     (13,647 )     (16,701 )

Interest income, net

     252       136       678       646  
                                

Net loss

   $ (3,273 )   $ (3,462 )   $ (12,969 )   $ (16,055 )
                                

Loss per share:

        

Basic and diluted

   $ (0.07 )   $ (0.10 )   $ (0.31 )   $ (0.47 )

Shares used in computing per share amounts

        

Basic and diluted

     47,524       34,915       42,133       34,349  

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

        

Research and development

   $ 333     $ 424     $ 1,371     $ 1,997  

General and administrative

     200       201       866       1,234  
                                
   $ 533     $ 625     $ 2,237     $ 3,231  
                                

Cortex Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)

 

     December 31,
2007
   December 31,
2006

Assets:

     

Cash and cash equivalents

   $ 4,021    $ 1,650

Marketable securities

     13,263      7,799

Other current assets

     247      525
             
     17,531      9,974

Furniture, equipment and leasehold improvements, net

     851      428

Other

     47      33
             

Total assets

   $ 18,429    $ 10,435
             

Liabilities and Stockholders’ Equity:

     

Accounts payable and accrued expenses

   $ 1,727    $ 2,056

Deferred rent liability

     25      58

Stockholders’ equity

     16,677      8,321
             

Total liabilities and stockholders’ equity

   $ 18,429    $ 10,435
             

MORE INFORMATION AT WWW.CORTEXPHARM.COM

#  #  #  #  #

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