RespireRx Pharmaceuticals Inc. Files September 30, 2016
Quarterly Report on Form 10-Q
GLEN ROCK, NJ-(Marketwired - Nov 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 September 30, 2016 Quarterly Report on Form 10-Q and is
hereby providing an update on the Company's ongoing clinical trials
and other matters.
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, stakeholders and other interested parties,
that the analyses of the results of the Phase 2 clinical trials of
CX1739 for opioid-induced respiratory depression and of dronabinol
for Obstructive Sleep Apnea are on schedule to be reported around
year-end 2016."
Dr. Manuso stated, "We are continuing our efforts to uplist
RespireRx to a national stock exchange. In support of that
initiative, as of September 1, 2016, we effected a 325-to-1 reverse
stock split, and we are working to fully fund our drug development
activities, including our clinical trial programs, and the
strengthening of our balance sheet."
Dr. Manuso concluded, "We encourage those interested in learning
more about the current clinical landscape for treating respiratory
diseases to follow developments at RespireRx."
Reverse Stock Split
On August 16, 2016, at a special meeting of the stockholders of
the Company, the stockholders approved an amendment to the
Company's Second Restated Certificate of Incorporation (i) to
effect, at the discretion of the Company's Board of Directors, a
325-to-1 reverse stock split of all of the outstanding shares of
the Company's common stock, par value $0.001 per share, and (ii) to
set the number of the Company's authorized shares of stock at
70,000,000 shares, consisting of 65,000,000 shares designated as
common stock, par value $0.001 per share, and 5,000,000 shares
designated as preferred stock, par value $0.001 per share. On
September 1, 2016, the Company filed a Certificate of Amendment to
the Company's Second Restated Certificate of Incorporation with the
Secretary of State of the State of Delaware to effect the approved
amendment.
All share and per share amounts with respect to common stock
presented herein have been retroactively restated to reflect the
325-to-1 reverse stock split.
Research and Development Overview
Key developments during the three months ended September 30,
2016 demonstrate considerable progress in clinical trial programs
as follows:
- The University of Illinois and three other research centers
recently completed a six week, placebo-controlled Phase 2B clinical
trial investigating the effects of dronabinol in patients with
Obstructive Sleep Apnea (OSA). This study was funded by the
National Heart, Lung and Blood Institute (NHLBI) of the National
Institutes of Health (NIH). The final progress report has been
submitted to the NIH by the principal investigators. The blinded
results of this trial are included as an exhibit to the Company's
Current Report on Form 8-K furnished and filed with the Securities
and Exchange Commission on November 1, 2016 and may be accessed at:
https://www.sec.gov/Archives/edgar/data/849636/000149315216014392/ex99-1.htm.
The Company expects to be able to announce the unblinded results of
the data analysis by the principal investigators around year-end
2016.
- The Company conducted a double-blind, placebo-controlled,
dose-ascending Phase 2A 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. This study completed dosing in June 2016 and was
formally completed on July 11, 2016. The Company expects to
complete a full analysis of the respiratory data and to issue a
final report on the results of the clinical trial around year-end
2016.
Financial Overview and Selected Financial Information
The Company incurred a net loss of $2,391,802 and $2,263,728 for
the three months ended September 30, 2016 and 2015, respectively,
and $7,804,002 and $4,241,312 for the nine months ended September
30, 2016 and 2015, respectively. The Company incurred negative
operating cash flows of $1,212,331 and $792,414 for the nine months
ended September 30, 2016 and 2015, respectively. The Company
expects to continue to incur net losses and negative operating cash
flows for the next few years.
The Company had shares of its Series G 1.5% Convertible
Preferred Stock issued and outstanding through April 17, 2016.
Accordingly, for the three months ended September 30, 2016 and
2015, the Company incurred a net loss attributable to common
stockholders of $2,391,802 and $2,264,836, respectively, reflecting
a net loss per common share of $1.18 for 2016 and $1.69 for 2015.
For the nine months ended September 30, 2016 and 2015, the Company
incurred a net loss attributable to common stockholders of
$7,805,167 and $4,247,192, respectively, reflecting a net loss per
common share of $4.31 for 2016 and $3.94 for 2015.
At September 30, 2016, the Company had 2,018,761 shares of
common stock outstanding, as compared to 1,507,221 shares of common
stock outstanding at December 31, 2015.
At September 30, 2016, the Company had a working capital deficit
of $4,889,965, as compared to a working capital deficit of
$2,922,279 at December 31, 2015, reflecting an increase in the
working capital deficit of $1,967,686 for the nine months ended
September 30, 2016. At September 30, 2016, the Company had cash
aggregating $39,553, as compared to $53,199 at December 31,
2015.
At September 30, 2016, the Company had $276,000 principal amount
of 10% convertible notes payable outstanding (plus accrued interest
of $54,528), which matured and became due and payable in full on
September 15, 2016. During October 2016, holders of four notes
totaling $73,004, which included accrued interest of $12,004 at
September 30, 2016, issued formal notices of default, and as a
result, those four notes were deemed to be in default under the
terms of the notes and began to accrue interest at the default rate
of 12% per annum from the default date in accordance with the terms
of the notes. The Company is continuing efforts to satisfy these
notes payable through the issuance of the Company's securities,
although there can be no assurances that the Company will be
successful in this regard.
The Company is working 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
September 30, 2016, as filed with the 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 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. 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.
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.
Company Contact: Jeff Margolis Vice-President, Treasurer and
Secretary Telephone: (917) 834-7206 E-mail:
jmargolis@respirerx.com
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