RespireRx Pharmaceuticals Inc. Files June 30, 2016 Quarterly
Report on Form 10-Q
GLEN ROCK, NJ-(Marketwired - Aug 15, 2016) - 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 occured during the second quarter of 2016. These important
milestones further establish the foundation for RespireRx's growth
going forward. Phase 2 clincal 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 clincal 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 in 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, deisgn, 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.
Contact Information
Company Contact:Jeff MargolisVice-President, Treasurer and
SecretaryTelephone: (917) 834-7206E-mail:
jmargolis@respirerx.com
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