Glen Rock, N.J., August 15, 2016/Globe Newswire – RespireRx Pharmaceuticals Inc. (OTCQB: RSPI) (“RespireRx” or the “Company”), a leader in the development of medicines for respiratory disorders, including sleep apneas and drug-induced respiratory depression, has filed its June 30, 2016 Quarterly Report on Form 10-Q and is hereby providing an update on the Company’s ongoing clinical trials, financing activities and its plans for the remainder of 2016.
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 to RespireRx shareholders the clinical development accomplishments that occurred during the second quarter of 2016. These important milestones further establish the foundation for RespireRx’s growth going forward. Phase 2 clinical trials for CX1739 for opioid-induced respiratory depression and dronabinol for Obstructive Sleep Apnea are on schedule to conclude and report results in the coming months.”
Dr. Manuso continued, “To fund our clinical trial activities, we successfully raised additional equity capital during the three months ended June 30, 2016. We are continuing our efforts to fully fund our drug development activities, including our clinical trial programs, and to strengthen our balance sheet.”
Dr. Manuso concluded, “We encourage those interested in learning more about the current clinical landscape for treating respiratory diseases to follow continuing developments at RespireRx.”
Developments during the Three Months Ended June 30, 2016
Key developments during the three months ended June 30, 2016 included the following:
- The Company conducted a Phase 2A human subject clinical trial at the Duke University School of Medicine to evaluate the Company’s lead oral compound, CX1739, for the prevention of respiratory depression caused by remifentanil, a potent opioid, while maintaining its desired analgesic effects. The double-blind, placebo-controlled dose-ascending Phase 2A clinical trial completed dosing in June 2016 and was formally completed on July 11, 2016. The Company expects to complete a preliminary top-line analysis of the respiratory data by the end of September 2016 and to issue a final report on the results of the clinical trial by the end of December 2016.
- A Phase 2B clinical trial evaluating dronabinol in 120 patients with Obstructive Sleep Apnea is being led by University of Illinois researchers. The University of Illinois has indicated that recruitment for this clinical trial was completed during the second quarter of 2016. Final research results are expected to be published in the fourth quarter of 2016.
- The Company raised aggregate gross proceeds of approximately $115,000 from the sale of units comprised of common stock and warrants and approximately $762,000 from warrant exchange transactions effected in conjunction with the Note Exchange Agreements and Unit Exchange Agreements.
- The Note Exchange Agreements resulted in the elimination from the Company’s balance sheet of convertible notes with a principal amount of $303,500, plus accrued interest of $40,993.
- All outstanding shares of Series G 1.5% Convertible Preferred Shares (including accrued but unpaid dividends) were automatically and mandatorily redeemed via conversion into shares of common stock on April 17, 2016.
- The Company presented at and otherwise participated in a number of investor conferences.
Research and Development Overview
RespireRx is a leader in the development of medicines for respiratory disorders, holding exclusive licenses and owning patents and patent applications for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders. The Company also controls rights and associated patents covering claims for novel uses of known drugs.
RespireRx has a pipeline of medicines in Phase 2 clinical trials focused on a variety of different breathing disorders. Clinical development advancements in the area of respiratory disorders, particularly drug-induced respiratory depression and sleep apnea, have created multiple opportunities for the ultimate commercialization of the Company’s medicines.
RespireRx’s pharmaceutical candidates in development, which are derived from two platforms, are as follows:
- One platform of medicines being developed by RespireRx is a class of proprietary compounds known as ampakines, which 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 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 damage 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.
- The other platform is the class of compounds known as cannabinoids, including, 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.
Information with respect to current clinical trials involving RespireRx’s pharmaceutical candidates is as follows:
- The Company filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) in September 2015 to conduct a double-blind, placebo-controlled, dose-ascending Phase 2A clinical trial in approximately 18 subjects to determine the ability of orally administered CX1739, the Company’s proprietary lead ampakine, to prevent the respiratory depression produced by remifentanil, a potent opioid, without altering remifentanil’s analgesic properties. The clinical protocol was designed to evaluate the safety and efficacy of three escalating doses of CX1739 versus placebo when administered prior to remifentanil, with respiration, analgesia and a number of other clinical measures being taken after administration of both drugs. The commencement of this clinical trial was subject to resolution of two deficiencies raised by the FDA in its clinical hold letter issued in November 2015. These issues were satisfactorily resolved in early 2016, and the FDA removed the clinical hold on the Company’s IND for CX1739 on February 25, 2016, thus allowing for the initiation of the clinical trial. During March 2016, upon receiving unconditional approval from the Institutional Review Board of the Duke Clinical Research Unit, this Phase 2A clinical trial at Duke University School of Medicine was initiated, with the dosing portion of the clinical trial completed in June 2016 and the clinical trial formally completed on July 11, 2016. The Company is currently working with the Duke University clinical research team to analyze the data collected. The Company expects to complete a preliminary top-line analysis of the respiratory data by the end of September 2016 and to issue a final report on the results of the clinical trial by the end of December 2016.
- The University of Illinois and three other research centers are currently investigating dronabinol in a potentially pivotal, six week, double-blind, placebo-controlled Phase 2B clinical trial in 120 patients with OSA. The University of Illinois has indicated that recruitment for this clinical trial was completed during the second quarter of 2016. Final research results are expected to be published in the fourth quarter of 2016. This clinical trial 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 clinical trial.
Financial Overview and Selected Financial Information
The Company incurred a net loss of $2,731,249 and $1,249,632 for the three months ended June 30, 2016 and 2015, respectively, and $5,412,200 and $1,977,584 for the six months ended June 30, 2016 and 2015, respectively. The Company incurred negative operating cash flows of $867,898 and $322,695 for the six months ended June 30, 2016 and 2015, respectively. The Company expects to continue to incur net losses and negative operating cash flows for the next few years.
As a result of adjustments related to the Series G 1.5% Convertible Preferred Stock, for the three months ended June 30, 2016 and 2015, the Company incurred a net loss attributable to common stockholders of $2,731,433 and $1,251,206, respectively, reflecting a net loss per common share of $0.00 for both 2016 and 2015. For the six months ended June 30, 2016 and 2015, the Company incurred a net loss attributable to common stockholders of $5,413,365 and $1,982,356, respectively, reflecting a net loss per common share of $0.01 for both 2016 and 2015.
At June 30, 2016, the Company had 656,159,420 shares of common stock outstanding, as compared to 489,846,883 shares of common stock outstanding at December 31, 2015. The exercise of all outstanding stock options and warrants, and the conversion of all outstanding convertible debt, would have resulted in the issuance of an additional 573,126,198 shares of common stock.
At June 30, 2016, the Company had a working capital deficit of $3,743,908, as compared to a working capital deficit of $2,922,279 at December 31, 2015, reflecting an increase in the working capital deficit of $821,629 for the six months ended June 30, 2016. At June 30, 2016, the Company had cash aggregating $347,256, as compared to $53,199 at December 31, 2015,
At June 30, 2016, the Company had $276,000 principal amount of 10% convertible notes payable outstanding (plus accrued interest of $46,757), which mature and become due and payable in full on September 15, 2016. The Company is continuing efforts to extend and/or satisfy these notes payable through the issuance of the Company’s securities prior to the maturity date, although there can be no assurances that the Company will be successful in this regard.
The Company is continuing efforts to raise additional capital in order to pay its liabilities, fund its business activities and underwrite its research and development programs. The Company regularly evaluates various means to satisfy the Company’s liquidity needs, including the development of agreements with collaborative partners and, when necessary, the exchange or restructuring of 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 fund its operating and debt service requirements. If the Company is unable to access sufficient cash resources on a timely basis, the Company may be forced to reduce operations indefinitely or to discontinue operations entirely and liquidate.
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 period ended June 30, 2016, 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 respiratory disorders, with a focus on sleep apneas and drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent applications 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 compounds in Phase 2 clinical development focused on pharmaceutical treatments for a variety of different 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.
In addition to its cannabinoid platform, RespireRx is developing pharmaceutical candidates derived from a platform of ampakines, a class of proprietary compounds 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 RespireRx 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 opioid-induced respiratory depression, without altering the analgesic effects. In animal models of orphan disorders, such as Pompe Disease, spinal cord damage 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 U.S. 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 we intend 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 our 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 our 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 our control. Although we believe 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 us or any other person that our 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.
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