RespireRx Pharmaceuticals Inc. Files December 31, 2015 Annual
Report on Form 10-K
Provides Update on Current Operations and Plans for 2016
GLEN ROCK, NJ-(Marketwired - Mar 29, 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 December 31, 2015 Annual Report on Form 10-K and is
hereby providing an update on the Company's current operations and
its plans for 2016.
The Company was formed in 1987 under the name Cortex
Pharmaceuticals, Inc. to engage in the discovery, development and
commercialization of innovative pharmaceuticals for the treatment
of neurological and psychiatric disorders. To reflect its current
strategic focus on respiratory disorders, the Company changed its
name from Cortex Pharmaceuticals, Inc. to RespireRx Pharmaceuticals
Inc. on December 16, 2015.
Comments by Chief Executive Officer
James S. Manuso, Ph.D., President, Chief Executive Officer and
Vice Chairman of RespireRx, commented, "The recently completed year
ended December 31, 2015 was a productive and noteworthy year for
RespireRx. We concentrated on the continuing focus of our
efforts on respiratory diseases and illnesses in which respiration
is compromised and for which there are no approved medicines, and
we expanded our clinical trial activities by initiating a Phase 2A
clinical trial with CX1739, the Company's proprietary lead
ampakine, during March 2016."
Dr. Manuso continued, "Also currently underway is a 120 patient,
Phase 2B clinical trial with dronabinol being conducted by the
University of Illinois, with data expected in the third quarter of
2016. 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."
Dr. Manuso concluded, "These efforts have enabled RespireRx to
emerge at the forefront of research and development in the fields
of sleep apneas and drug-induced respiratory depression. Going
forward, it is our goal to build on our 2015 research, clinical and
regulatory accomplishments, and to continue the development of our
Phase 2 medicines now in clinical trials. We look forward to
updating you during 2016 as we continue to move forward."
Corporate Overview
Key corporate developments during 2015 include the
following:
- On August 18, 2015, the Company entered into an employment
agreement with Dr. James S. J. Manuso to be its new
President and Chief Executive Officer. Dr. Manuso was
also appointed to the Company's Board of Directors and elected
as Vice Chairman of the Board of Directors.
- Concurrent with the hiring of Dr. Manuso, Dr. Arnold S. Lippa
was named Chief Scientific Officer of the Company and resigned as
President and Chief Executive Officer. Dr. Lippa continues to
serve as the Company's Executive Chairman and as a member of the
Board of Directors.
- The Company raised aggregate gross proceeds of approximately
$1,405,000 in the final closing of a convertible note and warrant
offering that commenced in 2014 and concluded in 2015, and a unit
offering of common shares and warrants that commenced and concluded
in 2015. During the first quarter of 2016, the Company raised
an additional approximately $195,000 from the sale of units of
common shares and warrants.
Research and Development Overview
RespireRx is a leader in the development of medicines for
respiratory disorders, holding 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.
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 are derived
from two platforms, as described below.
- The first platform is the class of compounds known as
cannabinoids, 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
("OSA").
- The second 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 opiois 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 year 2015 was an important period that saw the expansion and
implementation of the Company's research and development programs,
including the following key developments:
- In an ongoing study, the University of Illinois and three
other centers currently are investigating dronabinol in a
six week, double-blind, placebo-controlled Phase 2B clinical
trial in 120 patients with OSA. This study, which the
University of Illinois has indicated it expects to be
completed during the second quarter of 2016, 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 ongoing clinical trial. Under
the terms of the Company's license agreement with the
University of Illinois, the Company will have access to the
data from this potentially pivotal Phase 2B study and
the commercialization rights.
- In September 2015, the Company filed an Investigational New
Drug (IND) application with the FDA 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 Company's IND for CX1739 was
allowed on February 25, 2016 and the trial was initiated in March
2016 at the Duke University School of Medicine Clinical Research
Unit. The Company expects to incur approximately $750,000 of
direct costs in 2016 with respect to this clinical trial, and to
complete the clinical trial in approximately four months.
- Based on preliminary, positive results for CX1739 in a
previously completed Phase 2A clinical trial in patients with
sleep apnea, the Company has assembled a clinical advisory
panel composed of key opinion leaders and is developing
preliminary plans for a Phase 2B study in patients with
central sleep apnea.
- CX1942, a soluble ampakine, is being developed as an injectable
formulation to be used in a hospital or surgical setting in
conjunction with opioids and anesthetics either during or after
surgery. In collaboration with investigators at the University
of Florida and funded by a Small Business Innovation Research
("SBIR") contract from the National Institute of Drug Abuse, animal
studies completed in 2015 indicate that CX1942 injected
intravenously, intramuscularly or subcutaneously can reverse the
respiratory depression produced by fentanyl and possibly opioids in
combination with other drugs. Such data will be used to
develop an injectable formulation with the flexibility to be
administered via different routes.
- During 2015, as part of its preclinical research program, the
Company, through Dr. John Greer, Chairman of the Company's
Scientific Advisory Board, engaged in research collaborations with
a number of academic institutions, resulting in a number of
published articles in scientific journals. As part of the
Company's collaborative program with the University of Florida,
studies with the Company's ampakines have determined that these
compounds improve breathing in animal models of spinal cord injury
and Pompe Disease. Based on these studies, the Company is
developing preliminary plans for Phase 2A studies in patients with
spinal cord injury and Pompe disease who experience respiratory
difficulties.
- As of October 19, 2015, the Company entered into an agreement
with the Medications Development Program of the National Institute
of Drug Abuse ("NIDA") to conduct research on the Company's
ampakine compounds CX717 and CX1739. Under the agreement, NIDA
will evaluate the compounds using pharmacologic, pharmacokinetic
and toxicologic protocols to determine the potential effectiveness
of the ampakines for the treatment of drug abuse and addiction.
Initial studies will focus on cocaine and methamphetamine addiction
and abuse, and will be contracted to outside testing facilities
and/or government laboratories, with all costs to be paid by NIDA.
The Company will provide NIDA with supplies of CX717 and CX1739 and
will work with the NIDA staff to refine the protocols and dosing
parameters. The Company will retain all intellectual property,
proprietary and commercialization rights to these compounds.
- On January 12, 2016, the Company entered into a Research
Contract with the University of Alberta in order to test the
efficacy of ampakines using a variety of dosages and formulations
as potential treatments for Pompe Disease, apnea of prematurity and
spinal cord injury, as well as to conduct certain
electrophysiological studies to explore the ampakine mechanism of
action for central respiratory depression. The Company agreed
to pay the University of Alberta total consideration of
approximately CAD$146,000 (currently approximately US$110,000), of
which all but US$64,000 has already been incurred and paid for
directly or in-kind. The University of Alberta will receive
matching funds through a grant from the Canadian Institutes of
Health Research, while the Company will retain the rights to
research results and any patentable intellectual property generated
by the research.
Financial Overview and Selected Financial Information
The Company incurred net losses of $5,961,892 and $2,707,535 for
the years ended December 31, 2015 and 2014, respectively, and
negative operating cash flows of $1,296,100 and $885,869 for the
years ended December 31, 2015 and 2014, 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 $5,968,759 and $12,768,307
for the years ended December 31, 2015 and 2014, reflecting a net
loss per share of $0.02 for 2015 and $0.07 for 2014.
At December 31, 2015, the Company had 489,846,883 shares of
common stock outstanding, as compared to 232,145,326 shares of
common stock outstanding as of December 31, 2014. 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 505,235,433 shares
of common stock.
If not earlier converted, the remaining outstanding shares of
Series G 1.5% Convertible Preferred Stock will be automatically and
mandatorily redeemed by conversion into shares of common stock on
April 17, 2016, the two year anniversary of the date that the last
shares of Series G 1.5% Convertible Preferred Stock were issued in
the Series G Private Placement, at the Conversion Price of $0.0033
per share.
At December 31, 2015, the Company had a working capital deficit
of $2,922,279, as compared to a working capital deficit of
$2,280,035 at December 31, 2014, reflecting a decrease in working
capital of $642,244 during 2015. At December 31, 2015, the
Company had cash aggregating $53,199, as compared to $162,752 at
December 31, 2014, reflecting a decrease in cash of $109,553 during
2015.
The Company will need to continue to raise additional capital to
be able to pay its obligations and fund its business activities
going forward. 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 on a timely basis, the Company may need
to scale back its research and development efforts and could be
forced to discontinue operations entirely.
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
Annual Report on Form 10-K for the fiscal year ended December 31,
2015, 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.
RespireRx's pharmaceutical candidates in development are derived
from two platforms, as described below.
The first platform is the class of compounds known as
cannabinoids, 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
("OSA").
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 OSA. This study, which the University of
Illinois has indicated it expects to be completed during the second
quarter of 2016, 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 ongoing clinical trial.
The second 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 their 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 of
ampakines that do not display the undesirable side effects
previously reported in animal models of earlier generations.
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.
Special Note Regarding Forward-Looking Statements: Certain
statements included or incorporated by reference in this news
release, including information as to the future financial or
operating performance of the Company and its drug development
programs, constitute forward-looking statements. The words
"believe," "expect," "anticipate," "contemplate," "target," "plan,"
"intend," "continue," "budget," "estimate," "may," "schedule" and
similar expressions identify forward-looking statements.
Forward-looking statements include, among other things, statements
regarding future plans, targets, estimates and assumptions.
Forward-looking statements are necessarily based upon a number of
estimates and assumptions that, while considered reasonable by the
Company, are inherently subject to significant business, economic
and competitive uncertainties and contingencies. Many factors could
cause the Company's actual results to differ materially from those
expressed or implied in any forward-looking statements made by, or
on behalf of, the Company. Due to these various risks and
uncertainties, actual events may differ materially from current
expectations. Investors are cautioned that forward-looking
statements are not guarantees of future performance and,
accordingly, investors are cautioned not to put undue reliance on
forward-looking statements due to the inherent uncertainty therein.
Forward-looking statements are made as of the date of this news
release and the Company disclaims any intent or obligation to
update publicly such forward-looking statements, whether as a
result of new information, future events or results 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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