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): February 10, 2017

 

RESPIRERX 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 February 10, 2017, RespireRx Pharmaceuticals Inc. (the “Company”) announced that the Company’s President and Chief Executive Officer, James S. Manuso, Ph.D., will be presenting at the BIO CEO & Investor Conference 2017. Dr. Manuso is scheduled to present at 1:00 p.m. Eastern Standard Time on Monday, February 13, 2017. The Conference is sponsored by the Biotechnology Innovation Organization (BIO) and will be held at the Waldorf Astoria Hotel, New York, New York on February 13 and 14, 2017.

 

The slide presentation that Dr. Manuso will be using at the conference 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 by clicking on the investors tab on the Company’s web-site (www.respirerx.com), and following the links and instructions in the press release announcing this presentation or by going to:

 

http://www.veracast.com/webcasts/bio/ceoinvestor2017/36118482417.cfm

 

The webcast replay will be available one hour after conclusion of the live event and the replay will expire on May 15, 2017. 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.

 

RESPIRERX PHARMACEUTICALS INC.
Date: February 10, 2017      
  By: /s/ Jeff E. Margolis
    Jeff E. Margolis
    Vice President, Treasurer and Secretary

 

     
 

 

EXHIBIT INDEX

 

Exhibit
Number
  Exhibit Description
     
99.1   Slide Presentation*
99.2   Press Release dated February 10, 2017*

 

* Furnished herewith.

 

     
 

 

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

     
     

 

 

 

RespireRx Pharmaceuticals Inc. to Present at BIO CEO &

Investor Conference 2017

 

CEO to review dronabinol, a Phase 3-ready medicine for the treatment

of obstructive sleep apnea, and provide pipeline update

 

Glen Rock, N.J., Feb. 10, 2017/Globe Newswire – RespireRx Pharmaceuticals Inc. (OTC QB: RSPI) (“RespireRx” or the “Company”), a leader in the development of medicines for the treatment of respiratory disorders for which there are no approved pharmaceuticals, particularly sleep apneas and respiratory depression resulting from pain management medicines and disabilities such as spinal cord injury, announces that the Company’s President, Chief Executive Officer and Vice Chairman of the Board of Directors, James S. Manuso, Ph.D., will present at the BIO CEO & Investor Conference 2017 on Monday, February 13, 2017 at 1:00 PM Eastern Standard Time. The Conference is sponsored by the Biotechnology Innovation Organization. Presentations will be held at the Waldorf Astoria Hotel in New York from February 13-14, 2017.

 

Dr. Manuso will discuss results from the successfully completed PACE Phase 2B trial, conducted by Dr. David Carley and colleagues at the University of Illinois at Chicago and Northwestern University, in which dronabinol (oral) was tested for the treatment of obstructive sleep apnea (“OSA”). In addition, Dr. Manuso will discuss results from a successfully completed Phase 2A trial in which acutely administered CX-1739 (oral) reduced opioid induced respiratory depression in a clinical model of chronic opioid consumption. He will also provide background information and descriptions of other product pipeline candidates.

 

Dr. Manuso’s presentation will be available by live webcast streaming online. To access the live audio webcast, log onto the RespireRx website at www.respirerx.com, click on the investors tab and follow the links this press release and click the link http://www.veracast.com/webcasts/bio/ceoinvestor2017/36118482417.cfm

 

The webcast replay will be available one hour after conclusion of live event and the replay will expire on May 15, 2017.

 

A copy of the slide presentation to be presented at the conference will be submitted to the Securities and Exchange Commission in a Current Report on Form 8-K prior to the presentation and will also be available in the investors section of the RespireRx website.

 

About RespireRx Pharmaceuticals Inc.

 

RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders, with a focus on sleep apneas and drug-induced respiratory depression. The Company owns patents and patent applications, and holds exclusive licenses, for certain families of chemical compounds that claim the chemical structures and their use in the treatment of these and other disorders. Pending additional funding, during 2017, the Company plans to: 1) meet with the FDA to discuss its Phase 3 clinical trial program to test the safety and efficacy of dronabinol (oral) for the treatment of OSA; 2) file an IND and initiate a Phase 2 clinical trial investigating the ability of CX717 to improve breathing in patients with spinal cord injury; and 3) file an IND and initiate a Phase 2 clinical trial investigating the ability of CX1739 to reduce central sleep apnea in patients taking chronic opioids.

 

RespireRx P h a rmac e utic a l s Inc., 1 26 V a ll e y Road, S u i t e C, G l e n Roc k , NJ 0 74 5 2_
www .RespireRx . c om

 

     
 

 

 

RespireRx’s pharmaceutical candidates in development are derived from two platforms, as described below.

 

The first platform is the class of compounds known as cannabinoids, including 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. As reported in a press release and on Form 8-K on December 23, 2016, Dr. David Carley and colleagues at the University of Illinois at Chicago and Northwestern University successfully completed the PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial, a potentially pivotal, six week, double-blind, placebo-controlled Phase 2B study of dronabinol for the treatment of OSA. Dronabinol significantly improved the primary outcome measures of Apnea Hypopnea Index (“AHI”), daytime sleepiness as measured by the Epworth Sleepiness Scale (“ESS”) and overall patient satisfaction as measured by the Treatment Satisfaction Questionnaire for Medications (“TSQM”). This study was fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health. The Company did not manage or fund this clinical trial.

 

In an earlier placebo-controlled, dose-ascending Phase 2A clinical study conducted by the Company, dronabinol produced a statistically significant reduction in the AHI, the primary therapeutic end-point, and was observed to be safe and well-tolerated in a group of patients with OSA.

 

The second platform of medicines being developed by RespireRx is a class of proprietary compounds known as ampakines that act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptor sites in the brain. Several ampakines in both oral and injectable form are being developed by the Company for the treatment of a variety of breathing disorders. In a recently completed Phase 2A clinical trial, acute administration of CX-1739 (oral) reduced the respiratory depression produced by remifentanil, a potent opioid, in a clinical model of chronic opioid consumption, without altering its analgesic effects. Furthermore, ampakines have have been demonstrated to improve breathing in animal models of disorders such as spinal cord injury, Pompé Disease, and perinatal respiratory distress. The Company’s compounds belong to a new class of ampakines that do not display the undesirable side effects previously reported for earlier generations of ampakines.

 

Additional information about the Company and the matters discussed herein can be obtained on the Company’s web-site at www.RespireRx.com or in the Company’s filings with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov .

 

Comments by the Company’s President and Chief Executive Officer

 

Dr. James S. Manuso, commented, “We look forward to advancing the many initiatives RespireRx is undertaking throughout the course of 2017. Now that the Company is Phase 3-ready with respect to the final clinical and regulatory development of dronabinol for the treatment of obstructive sleep apnea, commercialization and potential partnering plans may be initiated. With dronabinol’s Phase 3 trial on the horizon, along with two Phase 2 or Phase 2-ready ampakine medicines in development, there are numerous strategic and operational milestones on the calendar. In 2017 we will continue to focus on the clinical and regulatory development of the Company’s two proprietary platforms for addressing unmet needs in the sleep apnea and opioid-induced respiratory depression markets. In addition, we will continue to support the scientific research and pre-clinical development upon which our company is based. I look forward to reporting to you our progress in the months ahead”

 

RespireRx P h a rmac e utic a l s Inc., 1 26 V a ll e y Road, S u i t e C, G l e n Roc k , NJ 0 74 5 2_
www .RespireRx . c om

 

     
 

 

 

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, Treasurer and Secretary

Telephone: (917) 834-7206
E-mail: jmargolis@respirerx.com

 

RespireRx P h a rmac e utic a l s Inc., 1 26 V a ll e y Road, S u i t e C, G l e n Roc k , NJ 0 74 5 2_
www .RespireRx . c om