RespireRx Pharmaceuticals Inc. Files June 30, 2017 Quarterly
Report on Form 10-Q And Provides Update
GLEN ROCK, NJ-(Marketwired - Aug 25, 2017) - 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
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