-----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, BZV/YI8jiEFpsnJmsW1Xyc43in+8+UDeqGqWo2q2VuEoAqZiCYoM10kpFzJoClMp k6HubVQnVLP1FYoHvk2s5w== 0001193125-08-173444.txt : 20080811 0001193125-08-173444.hdr.sgml : 20080811 20080811161102 ACCESSION NUMBER: 0001193125-08-173444 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080811 DATE AS OF CHANGE: 20080811 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: 081006376 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)

August 11, 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 August 11, 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 August 11, 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: August 11, 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 August 11, 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 SECOND QUARTER OPERATING RESULTS

— Results Reflect Increased Clinical Development Activity —

IRVINE, CA (August 11, 2008) — Cortex Pharmaceuticals, Inc. (AMEX: COR, http://www.cortexpharm.com) reported a net loss of $3,947,000, or $0.08 per share for the quarter ended June 30, 2008 compared with a net loss of $2,850,000, or $0.07 per share for the corresponding prior year period. Non-cash stock-based compensation charges for the quarters ended June 30, 2008 and 2007 totaled approximately $339,000 and $416,000, respectively.

For the six months ended June 30, 2008, Cortex reported a net loss of $8,318,000, or $0.17 per share compared to a net loss of $6,734,000, or $0.17 per share for the corresponding prior year period. Non cash stock-based compensation charges for the six months ended June 30, 2008 and 2007 were approximately $746,000 and $1,069,000, respectively.

Operating results for the three and six months ended June 30, 2008 reflect increased clinical development expenses, including costs related to the company’s two Phase IIa human clinical trials of AMPAKINE® CX717 as a potential acute treatment for respiratory depression.

As recently reported, top-line results from the first clinical study demonstrated that a single oral dose of 2100mg of CX717 has positive effects on respiratory depression induced by alfentanil, a pain-relieving opiate. The primary performance measures for the study were derived from a re-breathing procedure that measured the breathing response of the subject to increased CO2 levels in the presence of the opiate. The primary measure, the minute expiratory volume (VE) at 55mgHg CO2 (VE55), was reversed by 2100mg of CX717 in comparison to placebo (p<0.03).

A second study is evaluating whether CX717 may prevent the respiratory depression induced by alfentanil, while preserving that opiate’s desired pain relieving effects. Studies of CX717 in animal models by Dr. John Greer at the University of Alberta have shown that AMPAKINE compounds do not interfere with the analgesic effects of opiates. The clinical phase of the second study has been completed. Related data management and analysis is underway and results are expected to be available in the next few weeks.

Cortex has also initiated human clinical trials for a new compound, CX1739, which was developed from the company’s new series of “low impact” AMPAKINE compound patents. Assuming that the Phase I studies with this compound are successful, Cortex plans to pursue CX1739 as a potential treatment for Attention Deficit Hyperactivity Disorder in efficacy trials slated for the second half of 2009.


On the balance sheet, Cortex’s cash and marketable securities as of June 30, 2008 totaled approximately $10,500,000, a decrease of approximately $3,500,000 from the end of the prior quarter.

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
June 30,
    Six months ended
June 30,
 
     2008     2007     2008     2007  
     (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  

Revenues

   $ —       $ —       $ —       $ —    

Operating expenses (A):

        

Research and development

     3,132       2,010       6,554       5,002  

General and administrative

     944       962       2,081       1,997  
                                

Total operating expenses

     4,076       2,972       8,635       6,999  
                                

Loss from operations

     (4,076 )     (2,972 )     (8,635 )     (6,999 )

Interest income, net

     129       122       317       265  
                                

Net loss

   $ (3,947 )   $ (2,850 )   $ (8,318 )   $ (6,734 )
                                

Loss per share:

        

Basic and diluted

   $ (0.08 )   $ (0.07 )   $ (0.17 )   $ (0.17 )

Shares used in computing per share amounts

        

Basic and diluted

     47,559       40,018       47,551       39,149  

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

        

Research and development

   $ 214     $ 265     $ 484     $ 725  

General and administrative

     125       151       262       344  
                                
   $ 339     $ 416     $ 746     $ 1,069  
                                

Cortex Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)

 

     June 30,
2008
   December 31,
2007
     (Unaudited)     

Assets:

     

Cash and cash equivalents

   $ 4,131    $ 4,021

Marketable securities

     6,369      13,263

Other current assets

     208      247
             
     10,708      17,531

Furniture, equipment and leasehold improvements, net

     901      851

Other

     47      47
             

Total assets

   $ 11,656    $ 18,429
             

Liabilities and Stockholders’ Equity:

     

Accounts payable and accrued expenses — current

   $ 2,536    $ 1,727

Deferred rent liability — long-term

     —        25

Stockholders’ equity

     9,120      16,677
             

Total liabilities and stockholders’ equity

   $ 11,656    $ 18,429
             

MORE INFORMATION AT WWW.CORTEXPHARM.COM

#    #    #    #    #

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