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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 9, 2023
RESPIRERX
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
1-16467 |
|
33-0303583 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S
Employer
Identification
No.) |
126
Valley Road, Suite C
Glen
Rock, New Jersey |
|
07452 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (201) 444-4947
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| N/A |
|
N/A |
|
N/A |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
October 9, 2023, ResolutionRx Ltd (“ResolutionRx”) a wholly owned Australian, public, unlisted subsidiary of RespireRx Pharmaceuticals
Inc. (“RespireRx” or the “Company”) entered into a Master Services Agreement (“MSA”) with
Ab Initio Pharma Pty Ltd, (“Ab Initio”) an Australian company for Ab Initio to manufacture, formulate, test and supply ResolutionRx
with therapeutic drugs based on lipid nanoparticle technology licensed from RespireRx to ResolutionRx.
The
initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for obstructive sleep apnea pursuant
to which Ab Initio will, among other things, manufacture and test our new dronabinol lipid nanoparticle formulation for pharmacokinetic,
pharmacodynamic, and pivotal clinical trials as well as ultimately for commercialization.
The
initial term of the MSA is two years and automatically renews for one year periods unless ResolutionRx provides written notice to Ab
Initio of its intent not to renew at least ninety days prior to the end of the initial term or any renewal term.
The
services to be provided are set forth in a work order attached as a schedule to the MSA.
The
MSA also provides for mutual indemnifications, describes the relationship of the parties and that ResolutionRx retains ownership of all
intellectual property and provides for confidentiality.
The
press release dated October 12, 2023 announcing inception of the Master Services Agreement is attached and furnished, not filed
as Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
A
list of exhibits that are furnished as part of this report is set forth in the Exhibit Index, which follows, and is incorporated herein
by reference.
EXHIBIT
INDEX
*
Furnished herewith.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| Date:
October 12, 2023 |
RESPIRERX
PHARMACEUTICALS INC. |
| |
(Registrant) |
| |
|
|
| |
By: |
/s/
Jeff E. Margolis |
| |
|
Jeff
E. Margolis |
| |
|
SVP,
CFO, Secretary and Treasurer |
Exhibit
99.1
RespireRx Pharmaceuticals Inc.’s Subsidiary ResolutionRx Ltd Enters
into Master Services Agreement for Dronabinol Manufacturing and Related Services
Glen
Rock, N.J., October 12, 2023/Globe Newswire – RespireRx Pharmaceuticals Inc. (OTC Pink Market: RSPI) (“RespireRx”
or the “Company”), focused on the discovery and development of innovative and revolutionary treatments to combat diseases
caused by disruption of neuronal signaling, and ResolutionRx Ltd (“ResolutionRx”), an unlisted public Australian company,
(Australian Company Number or ACN: 664 925 651) and a subsidiary of RespireRx, are pleased to announce that on October 9, 2023, ResolutionRx
entered into a Master Services Agreement (“MSA”) with Ab Initio Pharma Pty Ltd, (“Ab Initio”) an Australian company
under which Ab Initio will manufacture, formulate, test and supply ResolutionRx with therapeutic drugs based on lipid nanoparticle technology
licensed from RespireRx.
The
initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for obstructive sleep apnea pursuant
to which Ab Initio will, among other things, manufacture and test our new dronabinol lipid nanoparticle formulation for pharmacokinetic,
pharmacodynamic, and pivotal clinical trials, as well as ultimately for commercialization. The initial term of the MSA is two years and
automatically renews for one-year periods unless ResolutionRx provides written notice to Ab Initio of its intent not to renew
at least ninety days prior to the end of the initial term or any renewal term.
“The
importance of this partnership cannot be overstated,” said Arnold Lippa, Ph.D., co-CEO and CSO of ResolutionRx and CEO and CSO
of RespireRx. “With its formulation expertise and GMP manufacturing facilities, Ab Initio will complete our original laboratory
experiments to determine a final, optimum dronabinol formulation, scale up and manufacture the chosen formulation for clinical use. The
lipid nanoparticle technology not only represents a major step forward in the development of dronabinol, but the potential for more widespread
use for insoluble or poorly soluble drugs.”
About
RespireRx Group
RespireRx
Pharmaceuticals Inc. and its subsidiaries and business units (“RespireRx Group”) are discovering and developing medicines
for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of
people, but for which there are few or poor treatment options, including obstructive sleep apnea (“OSA”), attention deficit
hyperactivity disorder (“ADHD”), epilepsy, pain, recovery from spinal cord injury (“SCI”), and certain neurological
orphan diseases . The RespireRx Group is developing a pipeline of new and repurposed drug products based on our broad patent portfolios
for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol
(“Δ9- THC”) that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which
include AMPAkines and GABAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”)
AMPA-type glutamate receptors and GABAA receptors, respectively.
The
RespireRx Group holds exclusive licenses and owns patents and patent applications or rights thereto 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.
ResolutionRx:
Pharmaceutical Cannabinoids.
ResolutionRx
Ltd (Australian Company Number a/k/a ACN 664 925 651) was formed in Australia on 11th January 2023 by RespireRx as an unlisted
public company. RespireRx has contributed by sublicense and license with ResolutionRx, its sleep apnea drug development program subject
to certain liabilities. ResolutionRx will now engage in the research and development (“R&D”) associated with that program,
initially for the development of a new formulation of dronabinol for use in a Phase 3 clinical trial and the filing of regulatory approval
for the treatment of obstructive sleep apnea (“OSA”). The current total budget for that program over the next several years
is approximately US$16.5 million, most, but not all of which is expected to be eligible for the Australian R&D Tax Incentive (“RDTI”).
Dronabinol, an endocannabinoid receptor agonist, has already demonstrated significant improvement in the symptoms of OSA in two Phase
2 clinical trials. OSA is a serious respiratory disorder that impacts an estimated 90 million people in the United States, Australia,
Germany and the United Kingdom and that has been linked to increased risk for hypertension, heart failure, depression, and diabetes.
There are no approved drug treatments for OSA.
Because
dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, RespireRx
and ResolutionRx further believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2)
new drug application (“NDA”), an efficient regulatory pathway that allows the use of publicly available data.
EndeavourRx:
Neuromodulators
GABAkines.
Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. (“UWMRF”) and on behalf
of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively
amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile
with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological
and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce
sedation, motor-impairment, tolerance, dependence and abuse. EndeavourRx currently is focusing on developing KRM-II-81 for the treatment
of epilepsy and pain.
KRM-II-81
has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and
pharmaco-resistant models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop
to its anti-convulsant properties. These latter results are particularly important because pharmaco-resistance occurs when medications
that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain
surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability
of KRM-II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment-resistant
epileptic patients undergoing surgery.
In
addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models
of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81
did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence,
respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart
of the opioid epidemic.
AMPAkines.
Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, RespireRx has developed
a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven
neurobehavioral and cognitive disorders, spinal cord injury, neurological diseases, and certain orphan indications. Our lead clinical
compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof
of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression.
AMPAkines
have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant
improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic
effects were observed within one week. We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid
onset of action than alternative non- stimulants, such as Straterra® (atomoxetine), and without the drawbacks of amphetamine-type
stimulants.
In
a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles,
Dr. David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, RespireRx’s
lead AMPAkines, to improve motor nerve activity and muscle function in a number of animal models of spinal cord injury (SCI).
Additional
information about RespireRx and the matters discussed herein can be obtained on the RespireRx web- site at www.RespireRx.com or
RespireRx’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Additional
information about ResolutionRx and the matters discussed herein can be obtained on the ResolutionRx website at https://www.resolutionrx.com.au.
Not
a Securities Offering or Solicitation
This
communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales
of securities in any jurisdiction in which such offer, solicitation or sale of securities would be unlawful before registration or qualification
under the laws of such jurisdiction.
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, as amended
(the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
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 future plans, targets, estimates, assumptions, 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.
In
some cases, forward-looking statements may be identified by words including “assumes,” “could,” “ongoing,”
“potential,” “predicts,” “projects,” “should,” “will,” “would,”
“anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,”
“contemplates,” “targets,” “continues,” “budgets,” “may,” or the negative
of these terms or other comparable terminology, although not all forward-looking statements contain these words, and such statements
may 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 product candidates, (iv) reorganization plans, and (v) the need for,
and availability of, additional financing. Forward-looking statements are based on information available at the time the statements are
made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance
or achievements to be materially different from the information expressed or implied by the forward- looking statements in this press
release.
These
factors include but are not limited to, regulatory policies or changes thereto, available cash, research and development results, issuance
of patents, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic
factors, and other risk factors disclosed in “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023 (the “2022 Form 10-K”).
You
should read these risk factors and the other cautionary statements made in the Company’s filings as being applicable to all related
forward-looking statements wherever they appear in this press release. We cannot assure you that the forward-looking statements in this
press release will prove to be accurate and therefore prospective investors, as well as potential collaborators and other potential stakeholders,
are encouraged not to place undue reliance on forward-looking statements. You should read this press release completely. Other than as
required by law, we undertake no obligation to update or revise these forward- looking statements, even though our situation may change
in the future.
We
caution investors, as well as potential collaborators and other potential stakeholders, not to place undue reliance on any forward-looking
statement that speaks only as of the date made and to recognize that forward- looking statements are predictions of future results, which
may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from
historical results, due to the risks and uncertainties described in the 2022 Form 10-K, in our quarterly reports on Form 10-Q and in
this press release, as well as others that we may consider immaterial or do not anticipate at this time. 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, regulatory and competitive conditions, collaborations with third parties, 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 we
believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will
prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions that we might make
or by known or unknown risks and uncertainties, including those described in the 2022 Form 10-K, in our quarterly reports on Form 10-Q
and in this press release. These risks and uncertainties are not exclusive and further information concerning us and our business, including
factors that potentially could materially affect our financial results or condition, may emerge from time to time.
For
more information about the risks and uncertainties the Company faces, see “Item 1A. Risk Factors” in our 2022 Form 10-K.
Forward-looking statements speak only as of the date they are made. The Company does not undertake and specifically declines any obligation
to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information
or future events or developments. We advise investors, as well as potential collaborators and other potential stakeholders, to consult
any further disclosures we may make on related subjects in our annual reports on Form 10-K and other reports that we file with or furnish
to the SEC including but not limited to our most recent Form 10-Q as of June30, 2023 filed with the SEC on August 21, 2023.
Company
Contacts:
Arnold
Lippa
ResolutionRx
Ltd.
Director
and co-Chief Executive Officer
0011+1+201-906-2467
alippa@ResolutionRx.com.au
www.ResolutionRx.com.au
Jeff
Margolis
RespireRx
Pharmaceuticals Inc.
Senior
Vice President, Chief Financial Officer, Treasurer and Secretary
Telephone:
917-834-7206
Email:
jmargolis@respirerx.com
126
Valley Road, Suite C
Glen
Rock, NJ 07452
www.respirerx.com
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RespireRx Pharmaceuticals (CE) (USOTC:RSPI)
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