SOURCE: Cortex Pharmaceuticals, Inc.

Cortex Pharmaceuticals, Inc.

August 19, 2015 08:30 ET

Cortex Pharmaceuticals, Inc. Announces Appointment of James S. J. Manuso, Ph.D., as President and Chief Executive Officer, Vice Chairman of the Board of Directors

Dr. Arnold S. Lippa, Ph.D., to Continue as Executive Chairman of the Board of Directors and Chief Scientific Officer

GLEN ROCK, NJ--(Marketwired - Aug 19, 2015) -  Cortex Pharmaceuticals, Inc. (OTCQB: CORX) ("Cortex" or the "Company"), a leader in the discovery and development of innovative pharmaceuticals for the treatment of breathing disorders, today announced the appointment of James S. J. Manuso, Ph.D., 66, as President and Chief Executive Officer, as well as Vice Chairman and a member of the Board of Directors, of the Company. Dr. Manuso also has agreed to subscribe to purchase newly issued securities of the Company in an amount of $250,000, on terms to be agreed between the parties. Dr. Manuso is currently the Chairman, Chief Executive Officer and sole shareholder of Talfinium Investments, Inc., an investment company focusing on publicly traded companies in the biotechnology and pharmaceutical industries. 

Cortex is a leader in developing drugs for respiratory disorders, particularly sleep apneas and drug-induced respiratory depression, and 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. Certain of these patents, which extend through at least 2028, claim the use of cannabinoids for the treatment of sleep related breathing disorders such as obstructive sleep apnea, as well as other patents that claim the chemical structures and uses of novel series of ampakines, including the Company's lead compounds CX1739 and CX1942. Preclinical and clinical research results have demonstrated the effectiveness of Cortex's ampakines in the treatment of central sleep apnea, as well as the respiratory depression associated with opiates and anesthetics, spinal injury, and genetic disorders such as Pompé Disease. 

Dr. Manuso, the new CEO of Cortex, is the former Chairman of the Board of Directors and Chief Executive Officer of Astex Pharmaceuticals, Inc. ("Astex") (NASDAQ: ASTX), having served in such positions from July 2011 through October 2013, at which time he successfully concluded efforts to sell Astex to Otsuka Pharmaceuticals, Inc. for $886 million. Dr. Manuso had previously served as the President and Chief Executive Officer, as well as Chairman of the Board of Directors, of Astex (formerly SuperGen, Inc.: NASDAQ: SUPG) from January 2004 to July 2011, and as a director of the company since February 2001. Dr. Manuso replaces Arnold S. Lippa, Ph.D., who will remain with Cortex as Executive Chairman of the Board of Directors and Chief Scientific Officer.

Dr. Manuso currently serves on the board of directors of privately-held KineMed, Inc. Previously, Dr. Manuso served on the boards of directors of The Biotechnology Industry Organization (BIO) and its Health Section Governing Board, Novelos Therapeutics, Inc. (NVLT.OB; now Cellectar Biosciences, Inc.), Symbiontics, Inc. (sold to BioMarin as ZyStor, Inc. for $115MM), Quark Pharmaceuticals, Inc., EuroGen, Ltd. (London, UK), where he was chairman, and other industry companies. Dr. Manuso previously served as Vice President and a member of the Board of Trustees of the Greater San Francisco Bay Area Leukemia & Lymphoma Society. Dr. Manuso began his career as vice president and Director of Health Care Planning and Development at The Equitable Companies (now Group Axa), where he also served as an Acting Medical Director. 

Dr. Manuso earned a B.A. with Honors in Economics and Chemistry from New York University, a Ph.D. in Experimental Psychophysiology and Genetics from the Graduate Faculty of The New School University, where he was a New School Scholar, a Certificate in Health Systems Management from Harvard University, and an Executive M.B.A. from Columbia Business School, where he was an Equitable Companies Scholar. Dr. Manuso is the author of over 30 chapters, articles and books on various topics, including health care cost containment and biotechnology company management.

In announcing Dr. Manuso's appointment, Dr. Lippa stated, "We are extremely pleased that at this strategic juncture in the Company's recovery and development, Dr. Manuso will be taking the helm of Cortex and leading the Company through to completion of its advancing clinical trials, next financings and infrastructure buildout. Dr. Manuso is a renowned biotechnology/pharmaceutical industry strategist and leader, a veteran Chief Executive Officer, and an entrepreneur experienced in the foundation, management, financing, governance and sale of start-up, public, private, domestic and international companies with marketed and R&D-stage products. Dr. Manuso has extensive M&A, general management, financial, corporate and drug development expertise, and is well-networked among investment bankers and research analysis in the financial industry."

In accepting his appointment, Dr. Manuso commented, "I am excited to be working with Dr. Lippa and the Cortex team to enhance the capital base of the Company and to manage the clinical and regulatory development of the Company's drug candidates for the treatment of respiratory disorders." 

About Cortex Pharmaceuticals, Inc.

Cortex Pharmaceuticals, Inc. is a biopharmaceutical company currently engaged in the development of drugs for the treatment of respiratory disorders. Drug candidates are currently derived from two platforms, as described below.

The first platform is a class of compounds known as ampakines that act as positive allosteric modulators of AMPA glutamate receptors. Several ampakines in both oral and injectable form are being developed by Cortex for the treatment of drug induced respiratory depression caused by opiates and anesthetics. In preclinical and clinical studies, such drugs have shown preliminary efficacy in central sleep apnea and in restoring normal respiration without altering the analgesic effects of opiates or the anesthetic effects of drugs such as propofol. The Company's compounds belong to a new generation of ampakines that do not display the undesirable side effects displayed by the earlier versions.

The second platform is the class of compounds known as cannabinoids, in particular, dronabinol. 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. Dronabinol is currently under investigation, at the University of Illinois and other centers, in a potentially pivotal 120 patient, double-blind, placebo-controlled Phase 2B OSA clinical trial, fully funded by the National Institutes of Health, which the University of Illinois currently expects to be completed during the second quarter of 2016. The Company is not involved in the management or funding of this ongoing clinical trial.

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.

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