RespireRx Pharmaceuticals Inc. Files March 31, 2016 Quarterly
Report on Form 10-Q
GLEN ROCK, NJ-(Marketwired - May 16, 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 March 31, 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
our shareholders that the RespireRx team has accomplished a great
deal during the first quarter of 2016, further laying the
foundation for our growth going forward. Our Phase 2 trials,
consisting of CX 1739 for opioid-induced respiratory depression and
dronabinol for Obstructive Sleep Apnea, are on schedule to conclude
and report results in the coming quarters. We have
successfully raised additional capital to fund our operations and
we are continuing our efforts to strengthen our balance sheet."
Dr. Manuso continued, "We are particularly concerned about the
opioid epidemic in our country and we remain committed to
addressing this problem with our Ampakine platform. Our
current Phase 2A trial at Duke University is specifically designed
to examine the ability of CX1739 to mitigate the respiratory
depressant actions of an opioid, the primary cause of opioid
lethality, without interfering with the pain management benefits of
the opioid."
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."
Corporate Overview
Key corporate developments during the three months ended March
31, 2016 included the following:
- The Company commenced a Phase 2A human subject clinical
trial testing 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 Company raised aggregate gross proceeds
of approximately $195,000 in several closings of a sale of
units comprised of common stock and warrants ("2016 Unit
Offering").
- The Company presented at and otherwise participated in a
number of investor conferences.
Key subsequent events after March 31, 2016 included the
following:
- The Company entered into exchange agreements with certain of
its investors from its 2014 and 2015 Note and Warrant Offering and
2015 Unit Offering through which it restructured some of its
outstanding securities. Funds raised from the Unit Exchange
Agreements and the Note Exchange Agreements through May 13, 2016
aggregated $655,250. In addition, as a result of these
transactions, the Company has eliminated from its balance sheet
convertible notes inclusive of accrued interest of $344,493 with a
face amount of $303,500, and reduced the number of shares of common
stock issuable pursuant to outstanding warrants by 41,465,718
shares.
- An additional $55,000 was raised pursuant to the 2016 Unit
Offering.
- All remaining Series G 1.5% Convertible Preferred Shares
("Series G Preferred Shares") were automatically and mandatorily
redeemed via conversion into shares of common stock on April 17,
2016, resulting in no Series G Preferred Shares remaining
outstanding.
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 use in the
treatment of a variety of disorders, as well as claims for novel
uses of known drugs.
The Company has a pipeline of compounds in Phase 2 clinical
development focused on developing drug 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.
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 (the "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. The
Company expects to complete the final data collection with respect
to the clinical trial by the end of May 2016, and to issue a report
on the results of the clinical trial during the third quarter of
2016.
- The University of Illinois and three other centers currently
are investigating dronabinol in a potentially pivotal, six week,
double-blind, placebo-controlled Phase 2B clinical trial in 120
patients with Obstructive Sleep Apnea. The University of
Illinois has indicated that it expects the final data collection
under this clinical trial to be completed in May 2016. The Company
is not managing or funding this ongoing clinical trial. This
clinical trial is fully funded by the National Heart, Lung and
Blood Institute of the National Institutes of Health.
Financial Overview and Selected Financial Information
The Company incurred net losses of $2,680,951 and $727,952 for
the three months ended March 31, 2016 and 2015, respectively, and
negative operating cash flows of $343,300 and $200,403 for the
three months ended March 31, 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, the Company incurred net losses
attributable to common stockholders of $2,681,932 and $731,150 for
the three months ended March 31, 2016 and 2015, respectively,
reflecting a net loss per share of $0.01 for 2016 and $0.00 for
2015.
At March 31, 2016, the Company had 498,622,133 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 and equity securities, would have
resulted in the issuance of an additional 699,518,827 shares of
common stock.
Subsequent to March 31, 2016, the Company entered into various
financing and exchange transactions to raise additional working
capital and relieve short-term debt obligations, which included the
exchange of $303,500 of the $579,500 principal amount of the 10%
convertible notes due September 15, 2016. In addition, on
April 17, 2016, the remaining unconverted 259.7 shares of Series G
1.5% Convertible Preferred Stock outstanding (including accrued but
unpaid dividends) were automatically and mandatorily redeemed by
conversion into 78,706,282 newly issued shares of common stock at a
conversion price of $0.0033 per share.
At March 31, 2016, the Company had a working capital deficit of
$3,838,542, as compared to a working capital deficit of $2,922,279
at December 31, 2015, reflecting an increase in the working capital
deficit of $916,263 for the three months ended March 31, 2016. At
March 31, 2016, the Company had cash aggregating $6,053, as
compared to $53,199 at December 31, 2015, reflecting a decrease in
cash of $47,146 for the three months ended March 31, 2016.
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, including a recent
increase in the Company's research and development
activities. 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.
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 March
31, 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 use in the treatment of a variety of
disorders, as well as claims for novel uses of known drugs.
Additional information about the Company and the matters
discussed herein can be obtained on the Company's website 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 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 Margolis Vice-President, Treasurer and
Secretary Telephone: (917) 834-7206 E-mail:
jmargolis@respirerx.com
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