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): October 19, 2015

 

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.)

 

126 Valley Road, Suite C

Glen Rock, New Jersey

  07452
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (201) 444-4947

 

 

(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 7.01 Regulation FD Disclosure

 

On October 19, 2015, Cortex Pharmaceuticals, Inc. (the “Company”) announced that the Company’s President and Chief Executive Officer, James S. J. Manuso, Ph.D., will be presenting at the 14th Annual BIO Investor Forum, sponsored by the Biotechnology Industry Organization, at The Parc 55 Hotel, San Francisco, California. Dr. Manuso is scheduled to present at 11:30 a.m. West Coast Time on Tuesday, October 20, 2015.

 

Dr. Manuso will present details of the Company’s clinical initiatives with respect to dronabinol for obstructive sleep apnea (Phase 2B) and the Ampakine CX-1739 (oral) for opiate induced respiratory depression (Phase 2A) and central sleep apnea (Phase 2B). Additional program and background information will also be provided.

 

The slide presentation that the Company will be using at the forum is attached as Exhibit 99.1 and is being furnished and not filed pursuant to Item 7.01 of Form 8-K. The presentation will be available by live webcast that can be accessed at:

 

http://www.veracast.com/webcasts/bio/investorforum2015/48108124757.cfm.

 

A replay also will be archived at the same web address beginning one hour after the conclusion of the live presentation.

 

The press release announcing the Company’s participation in the conference is attached as Exhibit 99.2.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

A list of exhibits that are furnished and filed as part of this report is set forth in the Exhibit Index, which is presented elsewhere in this document, and is incorporated herein by reference.

 

 
 

 

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.

 

Date: October 20, 2015 CORTEX PHARMACEUTICALS, INC.
     
  By: /s/ James S. J. Manuso
    James S. J. Manuso
    President and Chief Executive Officer

 

 
 

 

EXHIBIT INDEX

 

Exhibit
Number
  Exhibit Description
     
99.1   Slide Presentation*
     
99.2   Press Release dated October 19, 2015*

 

* Furnished herewith.

 

 
 

 

Exhibit 99.1

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 

 
   

 

 
   

 

Exhibit 99.2

 

 

 

Cortex Pharmaceuticals, Inc. to Present at

the 14th Annual BIO Investor Forum

 

Cortex CEO James S. J. Manuso, Ph.D. to Present

 

Glen Rock, N.J., October 19, 2015/Globe Newswire - Cortex Pharmaceuticals, Inc. (OTC: CORX) (“Cortex” or the “Company”), a leader in developing drugs for respiratory disorders, particularly obstructive and central sleep apneas and drug-induced respiratory depression, announces that it will be presenting at the 14th Annual BIO Investor Forum (www.bio.org). The conference is being sponsored by the Biotechnology Industry Organization and is being held on October 20 - 21, 2015 at the Parc 55 Hotel, San Francisco, California. The Company’s CEO, James S. J. Manuso, Ph.D. is scheduled to present at 11:30 a.m. West Coast Time on Tuesday, October 20, 2015.

 

The conference is attended by public companies, institutional investors, industry executives, private equity firms, private companies, venture capitalists, business development executives and sophisticated private investors.

 

The presentation will be accessible by live audio webcast at http://www.veracast.com/webcasts/bio/investorforum2015/48108124757.cfm. A replay of the live audio webcast will be archived at the same website address and will be available one hour after the conclusion of the live event. A copy of the slide presentation to be presented by the Company is being furnished as an exhibit to a Current Report on Form 8-K being filed with the U.S. Securities and Exchange Commission and also will be accessible in the investors section of the Cortex web-site.

 

Dr. Manuso will present details of Cortex’s clinical initiatives with respect to dronabinol for obstructive sleep apnea (Phase 2B) and the Ampakine CX-1739 (oral) for opiate induced respiratory depression (Phase 2A) and central sleep apnea (Phase 2B). Additional program and background information will also be provided.

 

About Cortex Pharmaceuticals, Inc.

 

Cortex is a leader in developing drugs for respiratory disorders, particularly sleep apneas and drug-induced respiratory depression. The Company owns patents and patent applications for certain families of chemical compounds that claim the chemical structures and their use in the treatment of these and other disorders.

 

Cortex Pharmaceuticals, Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452 www.cortexpharm.com

 

   
 

 

Drug candidates are currently derived from two platforms, as described below.

 

The first platform is the class of compounds known as cannabinoids, in particular, dronabinol. Under a license agreement with the University of Illinois, the Company has rights to patents claiming the use of cannabinoids for the treatment of sleep related breathing disorders. In a double-blind, placebo-controlled, dose-ascending Phase 2A clinical study conducted by the Company, dronabinol produced a statistically significant reduction in the Apnea-Hypopnea Index, the primary therapeutic end-point, and was observed to be safe and well tolerated in a group of patients with obstructive sleep apnea (OSA). The University of Illinois and three other centers currently are investigating dronabinol in a potentially pivotal, six week, double-blind, placebo-controlled Phase 2B clinical trial in 120 patients with OSA. This study, which the University of Illinois expects to be completed during the second quarter of 2016, is fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health. The Company is not managing or funding this ongoing clinical trial.

 

The second platform is a class of proprietary compounds known as ampakines that act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines in both oral and injectable form are being developed by Cortex for the treatment of a variety of breathing disorders. In clinical studies, such drugs have shown preliminary efficacy in central sleep apnea and in antagonizing respiratory depression produced by opiates without altering their analgesic effects. Ampakines also have improved breathing in animal models of orphan disorders such as Pompé Disease, spinal cord damage and perinatal respiratory distress. The Company’s compounds belong to a new generation of ampakines that do not display the undesirable side effects of earlier versions observed in animal models.

 

Additional information about Cortex and the matters discussed herein can be obtained on the Company’s web-site at www.cortexpharm.com or in the Company’s filings on EDGAR at www.sec.gov.

 

Special Note Regarding Forward-Looking Statements: Certain statements included or incorporated by reference in this news release, including information as to the future financial or operating performance of the Company and its drug development programs, constitute forward-looking statements. The words “believe,” “expect,” “anticipate,” “contemplate,” “target,” “plan,” “intend,” “continue,” “budget,” “estimate,” “may,” “schedule” and similar expressions identify forward-looking statements. Forward-looking statements include, among other things, statements regarding future plans, targets, estimates and assumptions. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Many factors could cause the Company’s actual results to differ materially from those expressed or implied in any forward-looking statements made by, or on behalf of, the Company. Due to these various risks and uncertainties, actual events may differ materially from current expectations. Investors are cautioned that forward-looking statements are not guarantees of future performance and, accordingly, investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. Forward-looking statements are made as of the date of this news release and the Company disclaims any intent or obligation to update publicly such forward-looking statements, whether as a result of new information, future events or results or otherwise.

 

Company Contact:

 

Jeff Margolis

Vice-President and Secretary

Telephone: (917) 834-7206

E-mail: jmargolis@cortexpharm.com

 

Cortex Pharmaceuticals, Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452 www.cortexpharm.com