RespireRx Pharmaceuticals Inc. CFO and CEO Issue Letter to Stockholders, Stakeholders, Strategic and Potential Strategic Partners and Other Interested Parties
RespireRx Pharmaceuticals (Ticker: RSPI) issued a year-end letter summarizing 2025 restructuring, financings, grants, and clinical progress. The company formed EndeavourRx (Jan 27, 2025) to develop AMPAkines and GABAkines and created ResolutionRx (Australia) to advance a dronabinol program for obstructive sleep apnea and access Australian R&D tax incentives.
Key funding and programs: a $1,793,411 DoD award for Phase 2A/2B CX1739 spinal cord injury trials; an NIH/NINDS $1,499,869 SBIR award$45 million allocated $15M to ResolutionRx, $25M to EndeavourRx, $5M to RespireRx. The company amended a patent license with UWM and plans ASX listing for ResolutionRx.
Regulatory note: the SEC issued a final Order revoking RSPI registration (effective Nov 14, 2025) under Section 12(j) for failure to file periodic reports since the Form 10-Q for period ended Sept 30, 2023.
RespireRx Pharmaceuticals (Ticker: RSPI) ha pubblicato una lettera di fine anno riassuntiva della ristrutturazione del 2025, finanziamenti, sovvenzioni e progressi clinici. L'azienda ha costituito EndeavourRx (27 gennaio 2025) per sviluppare AMPA-kine e GABA-kine e ha creato ResolutionRx (Australia) per avanzare un programma dronabinolo per l'apnea ostruttiva del sonno e accedere agli incentivi fiscali per la ricerca e sviluppo australiani.
Principali finanziamenti e programmi: una premio DoD di $1,793,411 per studi di fase 2A/2B CX1739 su lesione midolare; un premio SBIR NIH/NINDS $1,499,869 (anno 1) verso lavori abilitanti IND per GABAkine KRM-II-81 (totale richiesto $2,999,738); e un'offerta Regulation D Rule 506(c) avviata mirata a $45 milioni con $15M destinati a ResolutionRx, $25M a EndeavourRx, $5M a RespireRx. L'azienda ha rinnovato una licenza di brevetto con l'UWM e prevede la quotazione su ASX per ResolutionRx.
Nota regolamentare: la SEC ha emesso un Ordine che revoca la registrazione RSPI (efficace dal 14 novembre 2025) ai sensi della Sezione 12(j) per mancato deposito di rapporti periodici dalla Form 10-Q per il periodo chiuso al 30 settembre 2023.
RespireRx Pharmaceuticals (Ticker: RSPI) emitió una carta de fin de año que resume la reestructuración de 2025, financiamientos, subvenciones y avances clínicos. La empresa formó EndeavourRx (27 de enero de 2025) para desarrollar AMPAquinas y GABAquinas y creó ResolutionRx (Australia) para avanzar un programa de dronabinol destinado a la apnea del sueño obstructiva y acceder a incentivos fiscales de I+D australianos.
Financiamiento y programas clave: una beca DoD de $1,793,411 para ensayos de fase 2A/2B CX1739 de lesión medular; una NIH/NINDS SBIR de $1,499,869 (año 1) hacia trabajos que habilitan IND para GABAkine KRM-II-81 (total solicitado $2,999,738); y una oferta regulatoria Regulation D Rule 506(c) iniciada con objetivo de $45 millones asignando $15M a ResolutionRx, $25M a EndeavourRx, $5M a RespireRx. La compañía enmendó una licencia de patente con UWM y planea cotizar en ASX para ResolutionRx.
Nota regulatoria: la SEC emitió una Orden final de revocación de la registración RSPI (vigente al 14 de noviembre de 2025) conforme a la Sección 12(j) por no presentar informes periódicos desde el Formulario 10-Q para el periodo terminado el 30 de septiembre de 2023.
RespireRx Pharmaceuticals (티커: RSPI)는 2025년 재구조화, 자금 조달, 보조금 및 임상 진전을 요약한 연말 서한을 발표했습니다. 회사는 EndeavourRx를( 2025년 1월 27일) 설립하여 AMPAkinine과 GABAkinine 개발하고, 호주에서 ResolutionRx를 설립하여 수면무호흡증 obstructive sleep apnea를 위한 dronabinol 프로그램을 진행하고 호주 R&D 세제 혜택에 접근했습니다.
주요 자금 조달 및 프로그램: CX1739 척수손상 2A/2B 임상 2단계 연구를 위한 미 국방부(DoD) 자금 $1,793,411; NIH/NINDS의 $1,499,869 SBIR 자금 (1년 차)으로 IND를 가능하게 하는 GABAkine KRM-II-81에 대한 연구에 대한(총 요청액 $2,999,738) 및 Regulation D Rule 506(c) 시작으로 목표가 $45백만이며 ResolutionRx에 $15M, EndeavourRx에 $25M, RespireRx에 $5M 배정. 회사는 UWM과 특허 라이센스 수정했고 ResolutionRx의 ASX 상장을 계획하고 있습니다.
규제 참고: SEC는 2025년 11월 14일 발효되는 Section 12(j)에 따라 RSPI 등록을 취소하는 최종 명령을 발행했습니다. 이는 2023년 9월 30일을 끝으로 한 기간의 Form 10-Q를 파일하지 않은 것에 대한 조치입니다.
RespireRx Pharmaceuticals (Ticker: RSPI) a publié une lettre de fin d'année résumant la restructuration de 2025, les financements, les subventions et les progrès cliniques. L'entreprise a créé EndeavourRx (27 janvier 2025) pour développer des AMPAkines et des GABAkines et a conçu ResolutionRx (Australie) pour faire progresser un programme de dronabinol destiné à l'apnée obstructive du sommeil et accéder aux incitations fiscales pour la R&D en Australie.
Financements et programmes clés : une bourse DoD de $1,793,411 pour les essais de phase 2A/2B CX1739 sur des lésions de la moelle épinière ; une bourse NIH/NINDS SBIR de $1,499,869 (année 1) en faveur des travaux permettant l'IND pour le GABAkine KRM-II-81 (total demandé $2,999,738) ; et une offre Regulation D Rule 506(c) commencée visant $45 millions avec 15M alloués à ResolutionRx, 25M à EndeavourRx, 5M à RespireRx. La société a modifié une licence de brevet avec l'UWM et prévoit une cotation sur l'ASX pour ResolutionRx.
Note réglementaire : la SEC a publié un arrêté final de révocation de l'enregistrement RSPI (effective au 14 novembre 2025) en vertu de la Section 12(j) pour non-fourniture de rapports périodiques depuis le Form 10-Q pour la période se terminant le 30 septembre 2023.
RespireRx Pharmaceuticals (Ticker: RSPI) hat einen Jahresbrief veröffentlicht, der die Umstrukturierung 2025, Finanzierungen, Zuschüsse und klinische Fortschritte zusammenfasst. Das Unternehmen hat EndeavourRx (27. Januar 2025) gegründet, um AMPAkinine und GABAkinine zu entwickeln, und ResolutionRx (Australien) ins Leben gerufen, um ein Dronabinol-Programm gegen obstruktive Schlafapnoe voranzutreiben und Zugang zu australischen F&E-Steueranreizen zu erhalten.
Wichtige Finanzierungen und Programme: eine DoD-Zuschuss über $1,793,411 für Phase-2A/2B CX1739 Rückenmarkverletzungs-Studien; ein NIH/NINDS $1,499,869 SBIR-Zuschuss (Jahr 1) für IND-ermöglichende Arbeiten für GABAkine KRM-II-81 (insgesamt beantragt $2,999,738); und ein begonnener Regulation D Rule 506(c) Offer mit Ziel $45 Millionen, davon $15M für ResolutionRx, $25M für EndeavourRx, $5M für RespireRx. Das Unternehmen hat eine Patentanmeldung mit der UWM geändert und plant einen ASX-Listing für ResolutionRx.
Regulatorischer Hinweis: Die SEC erließ einen endgültigen Beschluss zur Aufhebung der RSPI-Registrierung (wirksam ab dem 14. November 2025) gemäß Section 12(j) wegen Nichterfüllung der Meldungspflichten seit dem Form 10-Q für den Zeitraum bis zum 30. September 2023.
RespireRx Pharmaceuticals (الرمز: RSPI) أصدرت رسالة نهاية العام تلخص إعادة الهيكلة لعام 2025، وتمويلات، منح، وتقدمات سريرية. أنشأت الشركة EndeavourRx (27 يناير 2025) لتطوير AMPAkines وGABAkines وأنشأت ResolutionRx (أستراليا) لدفع برنامج درونابينول لعلاج انقطاع النفس الانسدادي النومي والوصول إلى حوافز البحث والتطوير الأسترالية.
التمويلات والبرامج الرئيسية: منحة DoD قدرها $1,793,411 للدراسات من المرحلة 2A/2B CX1739 لإصابة النخاع الشوكي؛ ومنحة NIH/NINDS $1,499,869 SBIR (السنة 1) نحو أعمال تمكين IND لـ GABAkine KRM-II-81 (إجمالي المطلوب $2,999,738)؛ وعرض Regulation D Rule 506(c) يهدف إلى $45 مليون مع تخصيص $15M لـ ResolutionRx، $25M لـ EndeavourRx، $5M لـ RespireRx. قامت الشركة بتعديل ترخيص براءة مع UWM وتخطط للإدراج في ASX لـ ResolutionRx.
ملاحظة تنظيمية: أصدرت SEC أمرًا نهائيًا بسحب تسجيل RSPI (ساري المفعول في 14 نوفمبر 2025) بموجب القسم 12(j) لفشلها في تقديم التقارير الدورية منذ نموذج 10-Q للفترة المنتهية في 30 سبتمبر 2023.
- DoD award of $1,793,411 for CX1739 SCI Phase 2A/2B trials
- NIH/NINDS SBIR year-1 award of $1,499,869 for KRM-II-81 IND work
- Commenced Regulation D offering targeting $45 million
- ResolutionRx secured R&D tax-credit financing option covering 43.5% of qualified Australian R&D
- Amended patent license with University of Wisconsin–Milwaukee to support GABAkine commercialization
- SEC final Order revoked RSPI registration under Section 12(j) effective Nov 14, 2025
- Company has not filed periodic SEC reports since the Form 10-Q for period ended Sept 30, 2023
- Planned up to 15% equity/equity-linked financing for ResolutionRx R&D is not yet consummated
Glen Rock, N.J., Nov. 20, 2025 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (RespireRx or the Company), and its subsidiaries, EndeavourRx LLC (EndeavourRx) and ResolutionRx Ltd (ResolutionRx), collectively, the RespireRx Group, leaders in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, today provides a progress and status report to its stockholders, stakeholders, strategic partners as well as other interested parties.
Dear Stockholders, Stakeholders, Strategic and Potential Strategic Partners and Other Interested Parties:
As we prepare to end 2025, we would like to provide you with this open letter summarizing our challenges, the strategies we have implemented and continue to implement to meet those challenges, our accomplishments during 2025 and our 2026 goals and plans. Of course, we can provide no assurance that we will achieve these goals (see cautionary note about forward-looking statements near the end of this letter), but we believe that they are based on realistic assumptions and are reasonably achievable. We will certainly work hard on your behalf to try to achieve what we lay out here.
We have experienced a number of financial challenges, which will come as no surprise to our followers, we have had important successes, particularly with our science and preclinical and clinical development. We have published in peer-reviewed journals several times in 2025, but importantly, these papers and those of prior years have been cited frequently by other peer-reviewed authors, which is an indication of their quality and relevance.
Strategic Restructuring and Grants
ResolutionRx Ltd - In 2023, we created ResolutionRx, currently a wholly-owned, unlisted public company in Australia, as the first in a series of steps that include, but are not limited to financings, research and clinical development, manufacturing, regulatory and compliance, all for the purpose of developing compounds that target the body’s endocannabinoid system, and in particular, the re-purposing of dronabinol, an endocannabinoid CB1 and CB2 receptor agonist, for the treatment of obstructive sleep apnea (“OSA”). The Company has contributed certain dronabinol assets and certain liabilities to ResolutionRx.
One of the main purposes for the creation of ResolutionRx was to allow it to participate in the Australian research and development tax incentive (credit) which in the case of ResolutionRx, is a refund of
EndeavourRx LLC - On January 27, 2025, we formed EndeavourRx, a wholly owned private company as a vehicle for developing AMPAkines and GABAkines, positive allosteric neuromodulators (PAMs) designed to enhance the actions of the neurotransmitters, glutamate and GABA, acting upon the AMPA glutamate and GABA-A receptors, respectively.
AMPAkines
Traumatic spinal cord injury (SCI) often results in neurogenic bladder dysfunction that produces a plethora of urological complications leading to reductions in the quality of life and an increased risk of premature death. Restoration of bladder function is ranked as one of the highest priorities by individuals with SCI (Bourbeau et al., Spinal Cord 58:1216–1226; 2020). Current treatment approaches usually require interventions such as catheterization for urinary voiding, which have their own set of risks and potentially significant set of complications. World-wide incidence rates range from 12 to 59 cases per million depending on the country (Amidei et al., Spinal Cord 60:812-819; 2022) and of these 70 -
Because of the promising animal research at Dr. Fuller’s laboratory (Univ. Florida), our collaborator, the Shirley Ryan AbilityLab (SRAL), one of the pre-eminent SCI treatment centers in the U.S., received notice of a
RespireRx’s responsibility is to manufacture and formulate the clinical material, reinstate the CX1739 IND and collaborate with SRAL. We are in the process of finalizing with SRAL the terms and conditions for a supply agreement.
The U.S. Army Medical Research Acquisition Activity, in support of the Congressionally Directed Medical Research Program (CDMRP), is the awarding and administering acquisition office and this work will be supported by the Department of Defense, in the amount of
In addition to studying AMPAkines in the treatment of SCI, we have submitted a grant application to the U.S. National Institutes of Health in order to conduct a Phase 2B clinical trial of CX1739 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a chronic and complex neurodevelopmental condition characterized by an ongoing pattern of inattention and/or hyperactivity-impulsivity that significantly interferes with functioning or development. Symptoms of ADHD often begin between the ages of 3 and 6 and persist during adolescence and adulthood. It is commonly associated with comorbidities such as learning disabilities, anxiety, depression, and substance use disorder, resulting in a substantial financial burden on both families and society. Current pharmacological treatments, including stimulants and non-stimulants have notable limitations. Stimulants only alleviate outward symptoms and offer limited benefit for higher order cognitive processes called executive functions, essential for goal-directed behavior and novel problem-solving. They also carry a risk of misuse and may contribute to substance use disorders. While non-stimulants offer an alternative, their efficacy and tolerability often vary significantly among different patient subgroups. Furthermore, these medications are frequently associated with adverse side effects, including cardiovascular issues that often lead to discontinuation. Thus, there is a pressing need for safer, more effective ADHD treatments that address both core symptoms and underlying cognitive deficits.
CX717 has not only shown unique and desirable properties when given in animal models of ADHD, but has demonstrated safety in human Phase 1 studies, successful receptor target engagement in humans during Phase 2A and efficacy in a successful Phase 2 clinical trial in adult subjects with ADHD. The planned Phase 2B ADHD clinical trial has been designed as a double blind, placebo-controlled study in order to confirm the results in the Phase 2A study, but also to establish the efficacy of CX717 in a larger study.
GABAkines
On September 23, 2025, RespireRx received a Notice of Award from the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), award number 1R44NS143576, under the Small Business Innovation Research (SBIR) program which was created by the U.S. Congress to strengthen the role of small innovative companies in federally supported research and development. The amount of the award is
Under an Amended and Restated Patent License Agreement entered into as of October 27, 2025 with the University of Wisconsin-Milwaukee (UWM) Research Foundation, Inc. and on behalf of its EndeavourRx LLC subsidiary, RespireRx has in-licensed rights to certain selectively acting GABAkines developed in the laboratory of Dr. James Cook, UWM Distinguished Professor Emeritus, 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 LLC will continue RespireRx’s focus on developing KRM-II-81 for the treatment of epilepsy and pain.
KRM-II-81 has displayed a high degree of anti-seizure activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant animal and other models (34 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 because 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 who underwent surgery (3 studies). We have also licensed and characterized the anti-seizure properties of a host of structural analogs of KRM-II-81 that will facilitate the overall development of this program.
In addition, KRM-II-81 has displayed remarkable analgesic activity in a broad range of preclinical studies (7 studies and other GABAkines in our portfolio in 3 additional studies). KRM-II-81 is currently being profiled for its analgesic and side-effect profile by the Division of Translational Research, at the NINDS. 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 analgesics that are at the heart of the opioid epidemic.
The UWM Research Foundation (UWMRF) and RespireRx Pharmaceuticals have amended and restated their patent license agreement to better align with current commercialization strategies. Key updates include updates on regulatory milestone-based payments, revising royalty structures, and adjustment of amounts and timing of patent cost reimbursements. The agreement also eliminates prior UWMRF equity provisions in favor of a fixed exit fee tied to certain liquidity events, while clarifying intellectual property definitions and streamlining diligence and reporting obligations. These changes reflect a shared commitment to flexibility and long-term success in advancing innovative neuromodulator programs.
Capital Raising
As we have stated previously, raising capital has been a problem and so we are very pleased that on Nov. 18, 2025, we announced the commencement of a Regulation D, Rule 506(c) exempt offering of securities, across the three entities of the RespireRx Group, RespireRx, EndeavourRx and ResolutionRx. The targeted raise is up to
Summary of the Offering
The financing will support the RespireRx Group’s ongoing and future research and development and clinical programs across the three affiliated entities.
Capital Allocation and Use of Proceeds
- ResolutionRx (Australia) —
$15 million - Advancing a proprietary dronabinol formulation for obstructive sleep apnea (OSA), addressing a large global patient population underserved by existing treatments. Proceeds will fund PK/PD studies, a Phase 3 clinical trial, and working capital needs.
- EndeavourRx LLC (Delaware) —
$25 million - Developing two innovative drug platforms:
• AMPAkines (CX1739 and CX717) for spinal cord injury and ADHD, supported by a U.S. Department of Defense grant and pending NIH funding.
• GABAkines (KRM-II-81) for treatment-resistant epilepsy and non-opioid pain.- Funds will accelerate preclinical, IND-enabling, and clinical development activities.
- Subject of NIH/NINDS SBIR Notice of Award to RespireRx of
$1.5 million for the first year of a two-year grant application totaling$3 million (see above).
- Developing two innovative drug platforms:
- RespireRx Pharmaceuticals Inc. (Delaware parent) —
$5 million - Proceeds will support corporate operations, governance, and intellectual property management across the RespireRx Group.
SEC Matters
On November 13, 2025, effective November 14, 2025 the Securities and Exchange Commission (“Commission”), in Administrative Proceeding File No. 3-22541, in Release No. 104178 issued an Order Making Findings and Revoking Registration of Securities Pursuant to Section 12(j) of the Securities Exchange Act of 1934.
The Commission stated “The Securities and Exchange Commission (“Commission”) deems it necessary and appropriate for the protection of investors to accept the Offer of Settlement submitted by RespireRx Pharmaceuticals Inc. (CIK No. 849636) (Ticker: RSPI) (“RSPI” or “Respondent”) pursuant to Rule 240(a) of the Rules of Fair Practice of the Commission, 17 C.F.R. §201.240(a), for the purpose of settlement of these proceedings initiated against Respondent on September 11, 2025, pursuant to Section 12(j) of the Securities Exchange Act of 1934 (“Exchange Act”).
The findings were that unsolicited quotations of the common stock of RSPI had been “submitted on the Expert Market of the OTC Link ATS…” and that RSPI had “failed to comply with Exchange Act 13(a) and Rules 13a-1 and 13a-13 thereunder because it had not filed any periodic reports with the Commission since it filed a Form 10-Q for the period ended September 30, 2023.”
Given the findings, the Commission “ORDERED, pursuant to Section 12(j) of the Exchange Act, that registration of each class of the securities of RespireRx Pharmaceuticals Inc…registered pursuant to Section 12 of the Exchange Act be, and hereby, is revoked.” The effective date of the revocation was November 14, 2025.
RSPI made the offer of settlement on September 30, 2025. Between September 30, 2025 and the date of the release, RSPI was awaiting determination as to whether its Offer would be accepted.
The government shut down was effective October 1, 2025 and reopened on November 12, 2025 and the Commission released the acceptance of the settlement on November 13, 2025.
There is no monetary fine.
The registration of our common stock which was the only class of securities previously registered has been revoked.
At this time, the Company plans to register it common stock, and possibly other classes of its stock on Form 10 in the future. Our understanding of the process is that the submission of Form 10 will require the filing of two years of audited financial statements. We currently believe that it would be most efficient from a time, resource and financial perspective to wait until after December 31, 2025 and file Form 10 with December 31, 2024 and December 31, 2025 audited financial statements. We further understand that a filed Form 10 filed under Section 12(g) becomes automatically effective sixty (60) days after filing. We also believe that from the effective date forward we would need to remain current with the required periodic filings and that we will not have to file any of the previously required but unfiled periodic filings. To learn more about Form 10, you may find it informative to read the material in the following link to the Commission website: https://www.sec.gov/files/form10.pdf and other available sources. The foregoing constitute forward-looking statements. You are cautioned to read the Cautionary Note Regarding Forward-Looking Statements below. We can provide no assurance that all or any of these will occur.
Looking Forward
In addition to the above, we intend to complete the discussions and execute a definitive agreement with SRAL.
We have identified two prospective local Australian professionals to serve as directors of ResolutionRx and we are finalizing the documents and agreements to officially bring them on board and replace our current local directors.
We intend to maintain, expand and enhance our intellectual property portfolio.
Pending the receipt of adequate finance, of which no assurance can be provided, we plan to activate or replace our IND for CX717, and engage in research, preclinical and clinical development beyond the scope of existing grant awards and grants applied.
And a Thank You
We would like to thank all of our shareholders, strategic vendors/collaborators, service providers, strategic partners and all other stakeholders for their patience and for standing with us as we advance the RespireRx Group and what we consider to be its very valuable and important assets.
And as we said in a press release/letter on February 10, 2025, we continue to believe that together, we can advance life-changing therapies, create value for our investors and other stakeholders, and positively impact the lives of patients worldwide.
About RespireRx Group
RespireRx Pharmaceuticals Inc. and its subsidiaries, EndeavourRx LLC and ResolutionRx Ltd, collectively, the RespireRx Group is 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 epilepsy, pain, attention deficit hyperactivity disorder (ADHD), recovery from spinal cord injury (SCI), certain neurological orphan diseases and obstructive sleep apnea (OSA). The RespireRx Group is developing a pipeline of new and repurposed drug products based on our broad patent portfolios for two drug platforms: (i) neuromodulators, which include GABAkines and AMPAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”) GABAA receptors and AMPA-type glutamate receptors, respectively that make up EndeavourRx LLC, and (ii) pharmaceutical cannabinoids, which include dronabinol, a synthetic compound that acts upon the nervous system’s endogenous cannabinoid receptors that make up ResolutionRx Ltd. Certain therapeutic opportunities have been retained at RespireRx.
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.
EndeavourRx LLC: Neuromodulators
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, SCI, 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 SCI. The DOD has provided a notice of award to our collaborator, the Shirley Ryan AbilityLab, of
EndeavourRx LLC will continue RespireRx’s focus on its AMPAkines programs.
GABAkines. Under an Amended and Restated Patent License Agreement entered into as of October 27, 2025 with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx LLC subsidiary, RespireRx has in-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 LLC will continue RespireRx’s focus 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 animal and other models (34 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 because 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 who underwent surgery (3 studies). We have also licensed and characterized the anti-seizure properties of a host of structural analogs of KRM-II-81 that will facilitate the overall development of this program.
In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies (7 studies and other GABAkines in our portfolio in 3 additional studies). KRM-II-81 is currently being profiled for its analgesic and side-effect profile by the Division of Translational Research, at the NINDS. 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 analgesics that are at the heart of the opioid epidemic.
On September 23, 2025, RespireRx received a Notice of Award from the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), award number 1R44NS143576, under the Small Business Innovation Research (SBIR) program which was created by the U.S. Congress to strengthen the role of small innovative companies in federally supported research and development. The amount of the award is
ResolutionRx Ltd: Pharmaceutical Cannabinoids.
ResolutionRx Ltd (Australian Company Number a/k/a ACN 664 925 651) was formed in Australia on January 11, 2023 by RespireRx as an unlisted public company. RespireRx has contributed by sublicense and license with ResolutionRx, its obstructive sleep apnea drug development program subject to certain liabilities. ResolutionRx now engages in the research and development (R&D) associated with that program, initially for the development of a new formulation of dronabinol for use in an anticipated pharmacokinetic and pharmacodynamic study of the lead new formulation to be followed by a Phase 3 clinical trial and the filing of regulatory approval for the treatment of OSA. The current total budget for that program over the next several years is approximately US
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. Similar rapid approval strategies are also available in the European Union.
The currently available commercial formulation of dronabinol which is available both as a branded and generic product is not ideal for indications requiring drug to be available for six or more hours. The RespireRx Group’s new formulations, of which one has been designated as the lead formulation for the dronabinol program is believed to overcome a number of the limitations and shortcomings of the current commercial formulation, including but not limited to the possibility of doses lower than those currently in the market (lower than 2.5mg, 5mg or 10mg, the currently available doses).
Additional information about RespireRx and the matters discussed herein can be obtained on the RespireRx website at www.RespireRx.com. Additional information about ResolutionRx and the matters discussed herein can be obtained on the ResolutionRx website at https://www.resolutionrx.com.au. Additional information about EndeavourRx LLC and the matters discussed herein can be obtained on the EndeavourRx website at https://endeavourrx.com.
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). We have not filed our Annual Report on Form 10-K for the year ended December 31, 2023 or for the year ended December 31, 2024, nor have we filed our quarterly Current Reports on Form 10-Q as of March 31, 2024, June 30, 2024, September 30, 2024, March 31, 2025, June 30, 2025 or September 30, 2025.
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 current and prospective investors, as well as current and potential collaborators and other current and 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 current and prospective investors, as well as current and potential collaborators and other current and 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, in our Current Reports on Form 8-K, and other reports that we file with or furnish to the SEC 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, in our Current Reports on Form 8-K, and other reports that we file with or furnish to the SEC 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 current and prospective investors, as well as current and potential collaborators and other current and 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 September 30, 2023 filed with the SEC on November 17, 2023. As noted above, we have not yet filed our Annual Report on Form 10-K for the year ended December 31, 2023 or for the year ended December 31, 2024, nor have we filed our quarterly reports on Form 10-Q as of March 31, 2024, June 30, 2024, September 30, 2024, March 31, 2025, June 30, 2025 or September 30, 2025.
Company Contact:
| Jeff Margolis Senior Vice President, Chief Financial Officer, Treasurer and Secretary RespireRx Pharmaceuticals Inc. 126 Valley Road, Suite C Glen Rock, NJ 07452 U.S. Telephone: 917-834-7206 | Email: jmargolis@respirerx.com jmargolis@endeavourrx.com jmargolis@resolutionrx.com.au | Websites: www.respirerx.com https://endeavourrx.com https://www.resolutionrx.com.au |