RespireRx Pharmaceuticals Inc. Announces NIH/NINDS Grant Award and Amended and Restated Patent License Agreement
RespireRx (OTC:RSPI) received an NIH/NINDS SBIR Notice of Award and amended its patent license with the University of Wisconsin Research Foundation.
The NIH award is $1,499,869 for the budget period Sep 23, 2025–Aug 31, 2026; the project spans Sep 23, 2025–Aug 31, 2027 and the two‑year application requested $2,999,738. The grant supports preclinical toxicology and IND‑enabling work for lead GABAkine KRM‑II‑81 to treat epilepsy. The amended license updates milestone payments, royalties, patent cost timing, and replaces prior equity with a fixed exit fee.
RespireRx (OTC:RSPI) ha ricevuto un NIH/NINDS SBIR Notice of Award e ha modificato la licenza patentuale con la University of Wisconsin Research Foundation.
L’ award NIH è di $1,499,869 per il periodo di budget Sep 23, 2025–Aug 31, 2026; il progetto si estende Sep 23, 2025–Aug 31, 2027 e la domanda biennale ha richiesto $2,999,738. La sovvenzione sostiene tossicologia preclinica e lavori abilitanti IND per il lead GABAkine KRM‑II‑81 per trattare l’epilessia. La licenza modificata aggiorna i pagamenti per traguardi, le royalty, i tempi dei costi dei brevetti e sostituisce l’ex equity con una tassa di uscita fissa.
RespireRx (OTC:RSPI) recibió un Aviso de Adjudicación SBIR de NIH/NINDS y corrigió su licencia de patentes con la Fundación de Investigación de la Universidad de Wisconsin.
El premio de NIH es de $1,499,869 para el periodo presupuestario 23 de septiembre de 2025 al 31 de agosto de 2026; el proyecto abarca 23 de septiembre de 2025 al 31 de agosto de 2027 y la solicitud de dos años solicitó $2,999,738. La subvención apoya toxicología preclínica y trabajos habilitantes para IND para el líder GABAkine KRM‑II‑81 para tratar la epilepsia. La licencia enmendada actualiza pagos por hitos, regalías, la temporización de costos de patentes y reemplaza la participación anterior por una tarifa de salida fija.
RespireRx (OTC:RSPI) NIH/NINDS SBIR 수상 통지서를 받았고 위스콘신 대학교 연구 재단과의 특허 라이선스를 수정했습니다.
NIH 수상은 예산 기간 2025년 9월 23일 ~ 2026년 8월 31일에 대한 $1,499,869이며; 프로젝트 기간은 2025년 9월 23일 ~ 2027년 8월 31일이고 2년 신청서는 $2,999,738를 요청했습니다. 보조금은 간질 치료를 위한 리드 GABAkine KRM‑II‑81의 IND 허가에 필요한 선행 독성학 연구를 지원합니다. 수정된 라이선스는 이정표 지불, 로열티, 특허 비용 시기를 업데이트하고 기존의 주식 지분을 고정된 종료 수수료로 대체합니다.
RespireRx (OTC:RSPI) a reçu un avis d’attribution NIH/NINDS SBIR et a modifié sa licence de brevets avec la Fondation de recherche de l’Université du Wisconsin.
L’aide NIH est de 1 499 869 $ pour la période budgétaire du 23 septembre 2025 au 31 août 2026; le projet s’étend du 23 septembre 2025 au 31 août 2027 et la demande de deux ans a demandé 2 999 738 $. Cette subvention soutient la toxicologie préclinique et les travaux permettant l’IND pour le GABAkine candidat KRM‑II‑81 afin de traiter l’épilepsie. La licence modifiée met à jour les paiements à des jalons, les redevances, le calendrier des coûts des brevets et remplace l’ancien capital par des frais de sortie fixes.
RespireRx (OTC:RSPI) erhielt eine NIH/NINDS SBIR-Zuweisung und hat seine Patentlizenz mit der University of Wisconsin Research Foundation geändert.
Die NIH-Zuweisung beträgt 1.499.869 USD für den Haushaltszeitraum 23. Sep 2025–31. Aug 2026; das Projekt erstreckt sich über 23. Sep 2025–31. Aug 2027 und der zweijährige Antrag beantragte 2.999.738 USD. Die Zuschuss unterstützt präklinische Toxikologie und IND-fördernde Arbeiten für das führende GABAkine KRM‑II‑81 zur Behandlung von Epilepsie. Die geänderte Lizenz aktualisiert Meilensteinzahlungen, Royalties, den Zeitplan der Patentanwaltskosten und ersetzt früheres Eigenkapital durch eine feste Exit-Gebühr.
RespireRx (OTC:RSPI) تلقّت إشعار منح NIH/NINDS SBIR وأعدت ترخيصها للملكية الفكرية مع مؤسسة أبحاث جامعة ويسكونسن.
الجائزة من NIH تبلغ $1,499,869 للفترة المخصّصة من 23 سبتمبر 2025 إلى 31 أغسطس 2026; يمتد المشروع حتى 23 سبتمبر 2025 إلى 31 أغسطس 2027 وطلب الطلب لمدة سنتين $2,999,738. تدعم المنحة الدراسات قبل المخبرية للسمّية وأعمال تعزيز IND للمركب الرائد GABAkine KRM‑II‑81 لعلاج الصرع. تُحدِث الرخصة المعدلة تحديثات لمدفوعات المعالم، الإتاوات، توقيت تكاليف براءات الاختراع، وتستبدل الملكية السابقة برسوم خروج ثابتة.
- NIH/NINDS SBIR award of $1,499,869 (budget period Sep 23, 2025–Aug 31, 2026)
- Project term Sep 23, 2025–Aug 31, 2027 (two years)
- KRM‑II‑81 active in 34 preclinical seizure models
- Human translational data: 3 brain‑slice studies showing reduced epileptiform activity
- Analgesic profile: 7 KRM‑II‑81 studies showing comparable or greater efficacy
- Awarded $1,499,869 vs $2,999,738 requested (≈50% of requested funding)
- License replaces UWMRF equity with a fixed exit fee, reducing potential equity upside
Glen Rock, N.J., Nov. 19, 2025 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce the receipt of a Notice of Award of a grant from the NIH/NINDS and entry into an Amended and Restated Patent License Agreement with the University of Wisconsin Research Foundation.
Summary of the NIH/NINDS GABAkines Grant
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.
Summary of Amended and Restated Patent License Agreement
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.
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.
About UWM Research Foundation, Inc.
The UWM Research Foundation (UWMRF) serves and supports UW-Milwaukee faculty, students, and staff through fostering corporate research partnerships; igniting UWM-founded startups through programs, funding, and education; and leveraging intellectual property expertise to further support innovation and partnering in the community and world.
Since its inception in 2006, the nonprofit has funded more than
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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 |
FAQ
How much NIH funding did RespireRx (RSPI) receive on Nov 19, 2025?
What period does the RespireRx NIH project (RSPI) cover?
What will RespireRx use the NIH/NINDS grant for regarding KRM‑II‑81 (RSPI)?
What changed in RespireRx's patent license with University of Wisconsin (RSPI)?
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