RespireRx Pharmaceuticals Inc. Announces a Department of Defense Award to Fund a Phase 2 Clinical Study to Determine the Safety and Efficacy of CX1739, its Lead AMPAkine, to Improve Bladder Function in Patients with Spinal Cord Injury

RespireRx Pharmaceuticals Inc. (OTC Pink Markets: RSPI) (RespireRx or the Company), focused on the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is delighted to announce that the Department of Defense (DOD) has approved a $1.8 million translational research award to Shirley Ryan AbilityLab to fund a two stage Phase 2A and 2B clinical study in order to determine the safety and efficacy of CX1739, its lead clinical AMPAkine, to improve bladder function and motor activity in individuals with spinal cord injury (SCI). This grant award supports the ongoing collaboration among scientist teams led by Milap Sandhu, PT, PhD, research scientist at Shirley Ryan AbilityLab, a rehabilitation research hospital in Chicago, and Dr. Arnold Lippa from RespireRx and Dr. David Fuller from the University of Florida.

The U.S. Army Medical Research Acquisition Activity, in support of the Congressionally Directed Medical Research Program (CDMRP), is the awarding and administering acquisition office and this work will be supported by the Department of Defense, in the amount of $1,793,411, through the Spinal Cord Injury Research Program under Award No. HT94252410497. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.

Shirley Ryan AbilityLab has been ranked number one in rehabilitation by U.S. News & World Report since 1991 and cares for patients with the most severe, complex conditions, including SCI.

As the Principal Investigator, Dr. Sandhu will conduct the clinical trials at Shirley Ryan AbilityLab. Dr. Sandhu and Shirley Ryan AbilityLab have been allocated $1.8 million to conduct the actual clinical study of which RespireRx has been allocated $252,200 to manufacture and formulate the clinical material, as well as update and submit the CX1739 investigational new drug application (IND). Budget projections have determined that these amounts should be sufficient to pay for manufacturing and clinical costs and the plan is to begin testing in patients by the 4th quarter 2024. The trial will consist of two stages, the first being a Phase 2A will be an ascending single dose safety and efficacy study and the second Phase 2B will consist of a double blind, placebo-controlled study in which participants will be given CX1739 or placebo twice daily for a total of seven days.

As we have disclosed in an earlier press release and peer review publications, traumatic SCI often results in neurogenic bladder dysfunction that produces a plethora of urological complications leading to reductions in the quality of life and an increased risk of premature death. Restoration of bladder function is ranked as one of the highest priorities by individuals with SCI (Bourbeau et al., Spinal Cord 58 :1216–1226; 2020). Current treatment approaches usually require interventions such as catheterization for urinary voiding, which have their own set of potentially significant risks and complications. World-wide incidence rates range from 12 to 59 cases per million depending on the country (Amidei et al., Spinal Cord 60 :812-819; 2022) and of these 70 - 84% showed neurogenic bladder dysfunction (Kumar et al., World Neurosurgery 113 :e345–e363;2018).

"I am delighted and grateful for this government funding that now allows us to extend Dr. Fuller's preclinical studies into the human domain. If CX1739 produces the same effects in humans that it has produced in animals, it potentially represents a novel and needed treatment for SCI," said Dr. Sandhu.

Dr. Arnold Lippa, CEO and CSO of RespireRx, commented that, "CX1739 has successfully completed multiple Phase 1 safety trials and Phase 2 proof of concept trials demonstrating target engagement. With this new non-dilutive funding, we have begun planning to conduct translational, Phase 2 studies in SCI patients late this year. We believe that this research has the potential to represent a breakthrough in the treatment of SCI, where it is badly needed."

He added that, "It has been a pleasure to work with Dr. Fuller, a long-time RespireRx collaborator, and his team of scientists. In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, he has demonstrated the ability of RespireRx's lead AMPAkines to improve motor nerve activity and muscle function in a number of animal models of SCI, including respiration and bladder functions.

About RespireRx Group

RespireRx Pharmaceuticals Inc. and its subsidiaries and business units (RespireRx Group) are discovering and developing medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including epilepsy, pain, attention deficit hyperactivity disorder (ADHD), recovery from SCI, certain neurological orphan diseases and obstructive sleep apnea (OSA). The RespireRx Group is developing a pipeline of new and repurposed drug products based on our broad patent portfolios for two drug platforms: (i) neuromodulators, which include GABAkines and AMPAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or "PAMs") GABA _A receptors and AMPA-type glutamate receptors, respectively, and (ii) pharmaceutical cannabinoids, which include dronabinol, a synthetic compound that acts upon the nervous system's endogenous cannabinoid receptors.

The RespireRx Group holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.

EndeavourRx: Neuromodulators

AMPAkines . Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, RespireRx has developed a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven neurobehavioral and cognitive disorders, SCI, neurological diseases, and certain orphan indications. Our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression.

AMPAkines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic effects were observed within one week. We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non-stimulants, such as Straterra ^® (atomoxetine), and without the drawbacks of amphetamine-type stimulants. In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, Dr. David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, RespireRx's lead AMPAkines, to improve motor nerve activity and muscle function in a number of animal models of SCI. The DOD has recently approved a $1.8 million grant to fund a Phase 2A/2B clinical study of CX1739 in individuals with SCI.

GABAkines . Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx business unit, RespireRx has in-licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABA _A receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. EndeavourRx currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.

KRM-II-81 has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant animal models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop to its anti-convulsant properties. These latter results are particularly important because pharmaco-resistance occurs when medications that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability of KRM- II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment-resistant epileptic patients who underwent surgery.

In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic.

ResolutionRx: Pharmaceutical Cannabinoids.

ResolutionRx Ltd (Australian Company Number a/k/a ACN 664 925 651) was formed in Australia on January 11, 2023 by RespireRx as an unlisted public company. RespireRx has contributed by sublicense and license with ResolutionRx, its sleep apnea drug development program subject to certain liabilities. ResolutionRx now engages in the research and development (R&D) associated with that program, initially for the development of a new formulation of dronabinol for use in a Phase 3 clinical trial and the filing of regulatory approval for the treatment of OSA. The current total budget for that program over the next several years is approximately US$16.5 million, most, but not all of which is expected to be eligible for the Australian R&D Tax Incentive (R&DTI). The R&DTI in the case of ResolutionRx is anticipated to be approximately 43.5% of qualified R&D expenditures. Dronabinol, an endocannabinoid receptor agonist, has already demonstrated significant improvement in the symptoms of OSA in two Phase 2 clinical trials. OSA is a serious respiratory disorder that impacts an estimated 90 million people in the United States, Australia, the United Kingdom and Germany and that has been linked to increased risk for hypertension, heart failure, depression, and diabetes. There are no approved drug treatments for OSA.

Because dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, RespireRx and ResolutionRx further believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2) new drug application (NDA), an efficient regulatory pathway that allows the use of publicly available data.

Additional information about RespireRx and the matters discussed herein can be obtained on the RespireRx website at www.RespireRx.com or RespireRx's filings with the U.S. Securities and Exchange Commission (the SEC) at www.sec.gov . Additional information about ResolutionRx and the matters discussed herein can be obtained on the ResolutionRx website at https://www.resolutionrx.com.au .

Not a Securities Offering or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of securities in any jurisdiction in which such offer, solicitation or sale of securities would be unlawful before registration or qualification under the laws of such jurisdiction.

Cautionary Note Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company's future plans, targets, estimates, assumptions, financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors.

In some cases, forward-looking statements may be identified by words including "assumes," "could," "ongoing," "potential," "predicts," "projects," "should," "will," "would," "anticipates," "believes," "intends," "estimates," "expects," "plans," "contemplates," "targets," "continues," "budgets," "may," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words, and such statements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company's product candidates, (iv) reorganization plans, and (v) the need for, and availability of, additional financing. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release.

These factors include but are not limited to, regulatory policies or changes thereto, available cash, research and development results, issuance of patents, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic factors, and other risk factors disclosed in "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023 (the 2022 Form 10-K). We have not yet filed our Annual Report on Form 10-K for the year ended December 31, 2023.

You should read these risk factors and the other cautionary statements made in the Company's filings as being applicable to all related forward-looking statements wherever they appear in this press release. We cannot assure you that the forward-looking statements in this press release will prove to be accurate and therefore current and prospective investors, as well as current and potential collaborators and other current and potential stakeholders, are encouraged not to place undue reliance on forward-looking statements. You should read this press release completely. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future.

We caution current and prospective investors, as well as current and potential collaborators and other current and potential stakeholders, not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the risks and uncertainties described in the 2022 Form 10-K, in our quarterly reports on Form 10-Q, in our Current Reports on Form 8-K, and other reports that we file with or furnish to the SEC and in this press release, as well as others that we may consider immaterial or do not anticipate at this time. These forward- looking statements are based on assumptions regarding the Company's business and technology, which involve judgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions, collaborations with third parties, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties, including those described in the 2022 Form 10-K, in our quarterly reports on Form 10-Q, in our Current Reports on Form 8-K, and other reports that we file with or furnish to the SEC and in this press release. These risks and uncertainties are not exclusive and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time. For more information about the risks and uncertainties the Company faces, see "Item 1A. Risk Factors" in our 2022 Form 10-K. Forward-looking statements speak only as of the date they are made. The Company does not undertake and specifically declines any obligation to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments. We advise current and prospective investors, as well as current and potential collaborators and other current and potential stakeholders, to consult any further disclosures we may make on related subjects in our annual reports on Form 10-K and other reports that we file with or furnish to the SEC including but not limited to our most recent Form 10-Q as of September 30, 2023 filed with the SEC on November 17, 2023. As noted above, we have not yet filed our Annual Report on Form 10-K for the year ended December 31, 2023.

Company Contact:

Jeff Margolis
Senior Vice President, Chief Financial Officer, Treasurer and Secretary
RespireRx Pharmaceuticals Inc.
126 Valley Road, Suite C
Glen Rock, NJ 07452
Telephone: 917-834-7206
Email: jmargolis@respirerx.com
www.respirerx.com

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otcqb:rspi rspi respirerx pharmaceuticals

RSPI

RespireRx Pharmaceuticals Inc. to Present at 2017 Rodman & Renshaw Conference

RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) (“RespireRx” or the “Company”), a leader in the development of medicines for the treatment of respiratory disorders, including sleep apnea, opioid-induced respiratory depression, and respiratory insufficiency due to spinal cord injury, announces that the Company’s Chief Executive Officer and Vice Chairman of the Board of Directors, James S. Manuso, Ph.D., will present at the 2017 Rodman & Renshaw Conference on Tuesday, September 12, 2017 at 1:45 PM Eastern Time The presentations will be held at the Palace Hotel in New York, September 11-12, 2017.
Dr. Manuso will discuss RespireRx’s successfully completed Phase IIB clinical trial of dronabinol in the treatment of obstructive sleep apnea, and will present the results of a Phase IIA trial evaluating the ability of CX-1739 (oral) to antagonize the drug-induced respiratory depression produced by the powerful opioid, remifentanil. He will also provide updated information and clinical development plans for the company’s pipeline products.
Dr. Manuso’s presentation will be available by live webcast streaming online and will be archived. To access the live audio webcast, go to https://wsw.com/webcast/rrshq27/rspi. 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 has licensed and owns patents and patent applications, and holds exclusive licenses, for certain use patents for the use of ampakines for the treatment of disordered breathing. During the first quarter of 2018, the Company plans to meet with FDA to discuss its Phase III clinical trial program to test the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea.
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, in particular, dronabinol. Under a license agreement with the University of Illinois, the Company has rights to patents covering the use of cannabinoids for the treatment of sleep-related breathing disorders. In a double-blind, placebo-controlled, dose-ascending Phase IIA clinical study, 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). These results were confirmed by a Phase IIB trial at the University of Illinois at Chicago and Northwestern University in which dronabinol proved to be safe and efficacious for the treatment of OSA in a six week, double-blind, placebo-controlled clinical trial in 56 patients with OSA. This study, which the University of Illinois completed during the third quarter of 2016, was fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health.
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 are being developed by the Company for the treatment of a variety of breathing disorders. In a recently completed Phase IIA clinical trial, CX-1739, one of our lead clinical compounds, was shown to reduce the respiratory depression produced by remifentanil, a potent opioid, without altering its analgesic effects. In a pilot study of sleep apnea, CX1739 has demonstrated early promise in the treatment of central sleep and mixed apneas. The Company plans to initiate a clinical trial in spinal cord injury patients with respiratory insufficiency based on positive pre-clinical findings from studies performed by our collaborators at the University of Florida.
The Company is also collaborating with academic researchers on translational research programs to develop the ampakines for the treatment of orphan diseases, including Pompé Disease, Fragile-X Syndrome, and perinatal respiratory distress, where the ampakines have shown effectiveness in animal models.
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.
Clinical Trial Plans for 2017 – Phase III Clinical Trial plans for Development of dronabinol
As reported in a press release and on Form 8-K on December 23, 2016, RespireRx announced positive results of the PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial conducted by Drs. David Carley and Phyllis Zee at the University of Illinois at Chicago and Northwestern University, respectively. The PACE trial, a Phase 2B study of dronabinol for the treatment of obstructive sleep apnea (“OSA”), clearly demonstrated that 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”). Based on these results, RespireRx will engage with FDA in Q1/2018 to agree upon the next steps in connection with the initiation of a pivotal Phase III clinical trial program testing the safety and efficacy of dronabinol in the treatment of obstructive sleep apnea.
Clinical Trial Plans for 2017 – Phase IIB Trial of CX1739 in Central Sleep Apnea
As previously reported, an acute dose of CX1739 improved respiratory function of subjects in a phase IIA trial of opioid induced respiratory depression using a clinical model of chronic opioid use. As a follow-up, RespireRx is planning a Phase II multiple dose study of CX1739 in subjects who are on chronic opioid therapy. Among patients on chronic opioid therapy for at least 6 months, the presence of apnea and hypopnea has been diagnosed in 50% – 75% of patients screened. Initially, these symptoms usually appear during sleep and are considered, by the National Institutes of Health (NIH) and the National Institute of Drug Addiction (NIDA), to be significant risk factors for opioid addiction and overdose. Therefore, the Phase 2 study is planned to evaluate the ability of CX1739 treatment to reduce apnea and hypopnea associated with central sleep apnea.
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 III-ready with respect to the final clinical and regulatory development of dronabinol for the treatment of obstructive sleep apnea, commercialization and potential partnering plans have been initiated. With dronabinol’s Phase III trial on the horizon, along with the Company’s Phase II ampakines 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 RespireRx is based. I look forward to reporting to you our progress in the months ahead.”
Cautionary Note Regarding Forward-Looking Statements:
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements.
In some cases, forward-looking statements may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s proposed products, and (iv) the need for, and availability of, additional financing.
The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward-looking statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the Company’s objectives or plans will be achieved.
Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the condensed consolidated financial statements (unaudited) and notes thereto included in Item 1 of the Company’s current Quarterly Report on Form 10-Q as of and for the periods ending June 30, 2017 and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, including the section entitled “Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.

CONTACT INFORMATION

Company Contact:
Jeff Margolis
Chief Financial Officer, Senior Vice-President, Treasurer and Secretary
Telephone: (917) 834-7206
E-mail: jmargolis@respirerx.com

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RespireRx Pharmaceuticals Inc. Files June 30, 2017 Quarterly Report on Form 10-Q And Provides Update

RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) (“RespireRx” or the “Company”), a leader in the development of medicines for the treatment of neurologically controlled respiratory disorders, including obstructive sleep apnea and opioid induced respiratory depression (a form of central apnea) and other respiratory and neurological conditions, has filed its June 30, 2017 Quarterly Report on Form 10-Q and is hereby providing an update on the Company’s operating and financing activities and its plans for the remainder of 2017.
Comments by Chief Executive Officer
James S. Manuso, Ph.D., President, Chief Executive Officer and Vice Chairman of RespireRx, commented, “We are pleased to report that RespireRx has retained a leading advisory firm to assist in the Company’s advancement of its objective to engage a partner for the further development into Phase 3 clinical trials of dronabinol for obstructive sleep apnea and of ampakines into Phase 2B clinical trials for the treatment of opioid-induced respiratory depression, a form of central apnea and other neurally mediated respiratory disorders. We look forward to reporting on our progress with respect to this initiative in the months ahead. Naturally, we continue to seek to raise additional capital to fund our operations and we are continuing our efforts to strengthen our balance sheet.”
Corporate Overview
Key corporate developments during the three months ended June 30, 2017 included the following:

On June 6, 2017 at the Sleep 2017 conference in Boston, MA, a podium presentation by the principal investigator described the breakthrough results, previously announced by the Company, of a Phase 2B study in which oral administration of dronabinol improved the symptoms of obstructive sleep apnea.
Also at the Sleep 2017 conference, Senior Vice President of Research and Development, Richard Purcell presented a poster (“Poster”) session entitled: “OPIOIDS AND SLEEP APNEA: ANTAGONISM OF REMIFENTANIL INDUCED RESPIRATORY DEPRESSION BY CX1739 IN TWO CLINICAL MODELS OF OPIOID INDUCED RESPIRATORY DEPRESSION.” SLEEP 2017 was the 31st Annual Meeting of the Associated Professional Sleep Societies LLC (“APSS”), a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.
The Company has advanced its discussions with potential strategic partners with respect to both its cannabinoid and its ampakine programs.

Subsequent to June 30, 2017:

The Company initiated a new securities offering as described in its June 30, 2017 Quarterly Report on Form 10-Q
The Company formalized by employment agreement amendment, the expanded role of Jeff Margolis as Senior Vice President and Chief Financial Officer in addition to his prior responsibilities as Treasurer and Secretary.

Financial Overview and Selected Financial Information
The Company incurred net losses of $1,584,066 and $2,731,433 for the three months ended June 30, 2017 and 2016, respectively, net losses of $3,053,212 and $5,412,200 for the six months ended June 30, 2017 and 2016 respectively, and negative operating cash flows of $456,393 and $867,898 for the six months ended June 30, 2017 and 2016, respectively. The Company expects to continue to incur net losses and negative operating cash flows for the next few years.
At June 30, 2017, the Company had 2,289,045 shares of common stock outstanding, as compared to 2,149,045 shares of common stock outstanding at December 31, 2016. The exercise of all outstanding stock options and warrants, and the conversion of all outstanding convertible debt securities, would have resulted in the issuance of an additional 2,707,345 shares of common stock as of June 30, 2017 as compared to 1,877,715 as of December 31, 2016.
At June 30, 2017, the Company had a working capital deficit of $6,336,751, as compared to a working capital deficit of $5,531,548 at December 31, 2016, reflecting an increase in the working capital deficit of $805,203 for the six months ended June 30, 2017. At June 30, 2017, the Company had cash aggregating $30,848, as compared to $92,040 at December 31, 2016, reflecting a decrease in cash of $61,192 for the six months ended June 30, 2017.
The Company is continuing its efforts to raise additional capital in order to be able to pay its liabilities and fund its business activities on a going forward basis. The Company regularly evaluates various measures to satisfy the Company’s liquidity needs, including developing agreements with collaborative partners and, when necessary, seeking to exchange or restructure the Company’s outstanding securities. As a result of the Company’s current financial situation, the Company has limited access to external sources of debt and equity financing. Accordingly, there can be no assurances that the Company will be able to secure additional financing in the amounts necessary to fully fund its operating and debt service requirements. If the Company is unable to access sufficient cash resources, the Company may be forced to discontinue its operations entirely and liquidate. As indicated in the Company’s June 30, 2017 Quarterly Report on Form 10-Q, RespireRx has initiated a new securities offering.
Additional information with respect to the Company’s financial condition, results of operations, cash flows, capital structure and other matters involving the business, operations and research and development activities of the Company is included in the Company’s Quarterly Report on Form 10-Q for the quarterly and six month periods ended June 30, 2017, as filed with the U. S. Securities and Exchange Commission.
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for neurologically controlled 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) file an IND and initiate a Phase 2 clinical trial investigating the ability of CX717 or CX1739 to improve breathing in patients with spinal cord injury; 2) 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 Obstructive Sleep Apnea; 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’s pharmaceutical candidates in development are derived from two platforms, as described below.
One 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. Ampakines have also demonstrated that they may have utility 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.
The other platform is the class of compounds known as cannabinoids, including dronabinol. Under a license agreement with the University of Illinois at Chicago, the Company has rights to patents claiming the use of cannabinoids for the treatment of sleep-related breathing disorders. The results of the PACE Phase 2B clinical study have been previously described by the Company in filings with the SEC as have the results of an earlier Phase 2A clinical study conducted by the Company. In both studies, 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.
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.
Cautionary Note Regarding Forward-Looking Statements:
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements.
In some cases, forward-looking statements may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s proposed products, and (iv) the need for, and availability of, additional financing.
The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward-looking statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the Company’s objectives or plans will be achieved.
Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the condensed consolidated financial statements (unaudited) and notes thereto included in Item 1 of the Company’s current Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, including the section entitled “Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.

CONTACT INFORMATION

Company Contact:
Jeff Margolis
Senior Vice-President, Chief Financial Officer, Treasurer and Secretary
Telephone: (917) 834-7206
E-mail: jmargolis@respirerx.com

Click here to connect with RespireRX Pharmaceuticals Inc (OTCQB:RSPI) to receive an Investor Presentation.

Source: www.marketwired.com

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RespireRx Pharmaceuticals to Present at 2017 Marcum MicroCap

RespireRx Pharmaceuticals (OTCQB:RSPI) will present new information at the 2017 Marcum MicroCap Conference.
As quoted in the press release:

Company’s President, Chief Executive Officer and Vice Chairman of the Board of Directors, Dr. James S. 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. Dr. Manuso will also provide a summary of near term plans and goals, background information and descriptions of other product pipeline candidates.
Dr. Manuso’s presentation will be available by live webcast streaming online and archived for 90 days. To access the webcast, go to https://wsw.com/webcast/marcum5/rspi or visit the RespireRx website at www.respirerx.com, click on the same link on the home page, or, click on the Investors tab and follow the links to this press release and click the webcast link.

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RespireRx Pharmaceuticals Inc. Announces Positive Results from Phase 2B PACE Study Conducted by the University of Illinois Dronabinol Reduces Symptoms of Obstructive Sleep Apnea

RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) is pleased to announce positive results of the PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial conducted by Dr. David Carley and colleagues at the University of Illinois at Chicago and Northwestern University. The PACE trial, a Phase 2B study of dronabinol for the treatment of obstructive sleep apnea (“OSA”), clearly demonstrates that dronabinol significantly improves 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”).

In a dose dependent fashion, treatment with 2.5 mg and 10 mg dronabinol once a day at night significantly reduces the Apnea Hypopnea Index (“AHI”), a measure of breathing abnormalities during sleep, in 56 patients with moderate to severe OSA who completed the study. Of these, 17 received placebo, 19 received the 2.5 mg dose and 20 received the 10 mg dose. Compared to average baseline AHI values of 26 + 12, six weeks of dronabinol administration to moderate to severe OSA patients reduced AHI values, compared to placebo, by 9.7 + 4 for the 2.5 mg dose and 13.2 + 4 for the 10 mg dose (p=.02 and p=.001, respectively, compared to control). Furthermore, treatment with 10 mg dronabinol significantly improved daytime sleepiness as measured by the ESS (p = 0.0001, compared to placebo) and achieved the greatest overall patient satisfaction with treatment (p=.02) as measured by the TSQM.
Arnold Lippa, Ph.D., Chief Scientific Officer and Executive Chairman commented, “We congratulate Dr. Carley and his colleagues at both the University of Illinois at Chicago and Northwestern University for the successful completion of the PACE trial. These positive results clearly demonstrate the potential for dronabinol to treat OSA, a serious condition affecting millions of people with very few viable treatment options. We plan to move forward with the development of dronabinol in OSA, and plan to meet with the FDA for a Special Protocol Assessment (“SPA”) to finalize the Phase 3 study required for approval using both fast track and breakthrough designations from the FDA to facilitate the development path.”
James S. Manuso, Ph.D., President, Chief Executive Officer and Vice Chairman stated, “We are very excited with the possibility of bringing to market the first drug treatment for OSA. We can now envision a small molecule, easy to use, oral medicine for OSA patients as an alternative to CPAP (continuous positive airway pressure) devices, surgery and other methods used to treat this underappreciated disease, which has such enourmous costs to society.”
“We look forward to discussing with investors the results of this trial at upcoming conferences.”
Read full company profile.
Background
Obstructive Sleep Apnea is the most common form of sleep apnea and affects 29.4 million Americans according to Frost & Sullivan. 5.9 million adults are diagnosed (23.5 million are undiagnosed). OSA, besides causing next day sleepiness which is a major cause of motor vehicle and industrial accidents, is also co-morbid with cardiovascular disease, type 2 diabetes and other conditions. Treatment options are limited and the most effective treatment, the CPAP device has an extremely high non-compliance rate. The overall cost to the U.S. economy of the diagnosed and undiagnosed portions of the OSA market are estimated to be $12.4 billion and $149.6 billion respectively for a total cost of $162.0 billion in 2015. There is no drug therapy approved for OSA. While certain stimulants such as modafinil and methylphenidate are FDA approved for next day sleepiness in certain OSA patients, they do not treat OSA itself. Dronabinol, currently formulated as a capsule, is believed to be much more user friendly than the current devices, should have a higher patient compliance rate, should work well in the moderate to mild patient segment, which represents approximately 50% of the overall OSA patient population, and may result in more of the currently undiagnosed patient population getting diagnosed.
Dronabinol is synthetic ∆9-THC (delta 9-tetrahydrocannabinol), one of the active cannabinoids found in marijuana. It is approved in the United States in 2.5mg, 5mg and 10mg capsules for the treatment of anorexia associated with AIDS and chemo-therapy induced nausea and vomiting. It is a schedule III drug meaning there is a low abuse potential, but it is monitored by the United States DEA (drug enforcement agency). It is Medicare part B reimbursed for its current approved indications. Use of dronabinol for the treatment of OSA is novel.
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 holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
RespireRx has a pipeline of medicines in Phase 2 clinical development focused on pharmaceutical treatments for a variety of breathing disorders. Clinical development in the area of respiratory disorders, particularly drug-induced respiratory depression and sleep apnea, has created opportunities for the development and commercialization of the Company’s compounds.
Cannabinoids. One platform being developed by RespireRx 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.
Ampakines. The other platform of proprietary medicines being developed by RespireRx are ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of breathing disorders. In clinical studies, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of orphan disorders, such as Pompe Disease, spinal cord injury and perinatal respiratory distress, it has been demonstrated that certain ampakines improve breathing function. The Company’s compounds belong to a new class that does not display the undesirable side effects previously reported for other 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 Securities and Exchange Commission at www.sec.gov.
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research, design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements.
In some cases, forward-looking statements may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s proposed products, and (iv) the need for, and availability of, additional financing.
The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward-looking statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the Company’s objectives or plans will be achieved.
Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This press release should be read in conjunction with the condensed consolidated financial statements (unaudited) and notes thereto included in Item 1 of the Company’s recently filed Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, including the section entitled “Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.
Click here to connect with RespireRX Pharmaceuticals Inc (OTCQB:RSPI) to receive an Investor Presentation.

RespireRx Pharmaceuticals Inc. Announces Data for CX1739 Clinical Study in Opioid Induced Respiratory Depression

RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) a leader in the development of medicines for respiratory disorders, including sleep apneas and drug-induced respiratory depression announces data for its CX1739 clinical study in opioid induced respiratory depression.

Comments by the Executive Chairman and Chief Scientific Officer
Arnold Lippa, Ph.D., Executive Chairman and Chief Scientific Officer commented, “We are pleased with the positive results of our recent Phase 2A study which encourages us to take CX1739 forward in additional studies. We look forward to conducting additional studies investigating the effects of CX1739 on opioid induced respiratory depression in post-surgical patients self-administering opioids in a hospital setting as well as on central sleep apnea in out-patients taking oral opioids chronically for pain management.”
Background
Opioid analgesics are now the most commonly prescribed class of medicines in the United States, where chronic pain is estimated to affect around 68 million people each year. In 2014 alone, U.S. retail pharmacies dispensed 245 million prescriptions for opioid pain relievers. Opioids are useful and effective analgesics but produce several unwanted side effects, including episodes of potentially life-threatening respiratory depression, which resulted in over 30,000 deaths in 2014. While some of these deaths are from abuse of opioids, a large number are accidental deaths by patients who require opioids for pain management, in both an acute and chronic setting.
The respiratory depression produced by opioids is most sensitively detected during sleep and is manifested as apnea/hypopnea or central sleep apnea (CSA). Opioid induced sleep apneas are observed with intravenous opioid infusions in a post-surgical hospital setting, where approximately 2 – 4% of the 51 million U.S. patients undergoing in-hospital surgery present with opioid induced CSA. Furthermore, patients chronically taking oral opioids for pain relief also present with CSA. In fact, approximately 40 – 50% of patients diagnosed with CSA are taking chronic, oral opioids. Overall, sleep apnea is the major risk factor for mortality and morbidity in opioid overdose. Clearly, preventing or reducing the respiratory depressive effects of opioids will save lives.
In short, there is very substantial unmet medical need and very large market potential in treating respiratory depression/sleep apnea in patients who require short term or long term treatment with opioids to manage their pain. CX1739 belongs to a class of drugs called ampakines that the Company is developing to be taken in conjunction with opioids in order to reduce respiratory depression without altering analgesia.
Summary of Clinical Trial Results
In order to understand the relevance of the data in this study, it is important to understand the conditions under which opioids are used. The preponderance of opioid use is for the treatment of pain. Regardless of whether the opioid is taken orally or intravenously, either acutely or chronically, the treatment of pain requires stable opioid blood levels that also can produce respiratory depression/sleep apnea. Alternatively, some opioid users consume a large acute dose of opioid, whether orally or intravenously, intentionally or accidentally, that also can produce potentially fatal respiratory depression. While opioid antagonists, such as Narcan®, are the gold standard for the treatment of acute opioid overdose, their use is inappropriate for patients taking the opioids for pain relief because they antagonize the analgesic effects of the opioids at the same time that they antagonize respiratory depression.
Read full company profile.
The recently completed Phase IIa clinical trial evaluated the ability of CX1739 to overcome the respiratory depression induced by the powerful, yet short-acting opioid, remifentanil, in two models of opioid use: During REMI-INFUSION, respiration, pain, and other parameters were measured during a 30 minute intravenous infusion of remifentanil in order to produce stable blood levels resulting in approximately 50% declines in respiratory rate over this period. During REMI-BOLUS, a model of acute opioid overdose, a single, intravenous bolus injection of remifentanil was administered at a dose calculated to achieve approximately 50% respiratory depression.
During REMI-INFUSION, CX1739 treatment antagonized the respiratory rate depression produced by remifentanil, with statistically significant effects observed at 300mg (p < .005) and 900mg (p < .001). The antagonism produced by the 600mg dose did not achieve statistical significance. This lack of a linear, dose response effect is not unusual in early stage clinical trials. During this period, CX1739 did not significantly alter the analgesic and sedative effects of reminfentanil.
During REMI-BOLUS, CX1739 treatment did not prevent respiratory depression, nor improve time to recovery at any of the doses tested.
Overall, CX1739 was found to be safe and well tolerated, both prior to and during administration of remifentanil. Treatment-related adverse events (AEs) for the various doses of CX1739 were mild, with an incidence comparable to that reported for placebo. The great majority of AEs occurred after remifentanil administration.
Description of the Study Design
The study consisted of two separate stages. Stage 1 was a randomized, double-blind, crossover study comparing 300 mg CX1739 to placebo and Stage 2 was an open-label, ascending dose study to assess 600 and 900 mg of CX1739. Subjects were tested once a week over a four-week period. Statistical comparisons were performed for Stage 1 alone as well as for Stage 1 and Stage 2 combined.
On each study day, REMI-BOLUS was initiated with an intravenous, bolus injection of remifentanil 3 hours after subjects received either placebo or CX1739. Respiration was measured for 20 minutes and then compared to the baseline respiration recorded 5 minutes prior to the bolus injection. REMI-INFUSION was initiated 3.5 hours after placebo or CX1739, with an intravenous infusion protocol designed to maintain stable remifentanil blood levels and calculated to produce approximately 50% respiratory depression.
The study was conducted at the Duke Clinical Research Unit of the Duke Clinical Research Institute. The ClinicalTrials.gov identifier is NCT02735629.
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 holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
RespireRx has a pipeline of medicines in Phase 2 clinical development focused on pharmaceutical treatments for a variety of breathing disorders. Clinical development in the area of respiratory disorders, particularly drug-induced respiratory depression and sleep apnea, has created opportunities for the development and commercialization of the Company’s compounds.
Ampakines. One platform of proprietary medicines being developed by RespireRx are ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of breathing disorders. In clinical studies, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of orphan disorders, such as Pompe Disease, spinal cord injury and perinatal respiratory distress, it has been demonstrated that certain ampakines improve breathing function. The Company’s compounds belong to a new class that does not display the undesirable side effects previously reported for other ampakines.
Cannabinoids. The other platform being developed by RespireRx 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. 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 OSA.
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 Securities and Exchange Commission at www.sec.gov.
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research, design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements.
In some cases, forward-looking statements may be identified by words including “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” and similar expressions include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s proposed products, and (iv) the need for, and availability of, additional financing.
The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic and competitive conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward-looking statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the Company’s objectives or plans will be achieved.
Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This press release should be read in conjunction with the condensed consolidated financial statements (unaudited) and notes thereto included in Item 1 of the Company’s recently filed Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, including the section entitled “Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.

Click here to connect with RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) to receive an Investor Presentation.

RespireRx Pharmaceuticals Inc. Announces a Department of Defense Award to Fund a Phase 2 Clinical Study to Determine the Safety and Efficacy of CX1739, its Lead AMPAkine, to Improve Bladder Function in Patients with Spinal Cord Injury

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