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RespireRx Pharmaceuticals Inc. Announces NIH/NINDS Grant Award and Amended and Restated Patent License Agreement
Globenewswire· 2025-11-19 14:30
Core Insights - RespireRx Pharmaceuticals Inc. has received a grant of $1,499,869 from the NIH/NINDS to support the development of its lead GABAkine, KRM-II-81, for the treatment of epilepsy [2][17] - The company has entered into an Amended and Restated Patent License Agreement with the University of Wisconsin Research Foundation to enhance its neuromodulator programs [3][6] Grant Details - The NIH/NINDS grant is awarded under the Small Business Innovation Research (SBIR) program, covering the budget period from September 23, 2025, to August 31, 2026, with a total requested amount of $2,999,738 over two years [2][17] - The project aims to complete preclinical toxicology studies to support the filing of an investigational new drug application (IND) for KRM-II-81 [2][17] Patent License Agreement - The Amended and Restated Patent License Agreement includes updates on regulatory milestone payments, royalty structures, and patent cost reimbursements [6][7] - The agreement eliminates prior equity provisions in favor of a fixed exit fee tied to liquidity events, streamlining diligence and reporting obligations [6][7] Product Development - KRM-II-81 has shown significant anti-seizure activity across 34 preclinical models, with no development of pharmaco-resistance or tolerance [4][14] - The compound has also demonstrated analgesic properties comparable to commonly used analgesics without the side effects associated with opioids [5][16] Company Overview - RespireRx Group focuses on developing treatments for psychiatric and neurological disorders, including epilepsy, pain, ADHD, and obstructive sleep apnea [8][9] - The company holds exclusive licenses and patents for various chemical compounds aimed at treating a range of disorders [9] Future Directions - EndeavourRx LLC will continue to focus on the development of KRM-II-81 and other GABAkines for neurological and psychiatric disorders [3][13] - The company is also advancing its AMPAkines programs, which have shown promise in treating CNS-driven neurobehavioral and cognitive disorders [10][12]
RespireRx Pharmaceuticals Inc. Announces NIH/NINDS Grant Award and Amended and Restated Patent License Agreement
Globenewswire· 2025-11-19 14:30
Core Insights - RespireRx Pharmaceuticals Inc. has received a grant of $1,499,869 from the NIH/NINDS to support the development of its lead GABAkine, KRM-II-81, for the treatment of epilepsy [2][17] - The company has entered into an Amended and Restated Patent License Agreement with the University of Wisconsin Research Foundation to enhance its neuromodulator programs [3][6] Grant Details - The NIH/NINDS grant is awarded under the Small Business Innovation Research (SBIR) program, covering the budget period from September 23, 2025, to August 31, 2026, with a total requested amount of $2,999,738 over two years [2][17] - The project aims to complete preclinical toxicology studies necessary for filing an investigational new drug application (IND) for KRM-II-81 [2][17] KRM-II-81 Development - KRM-II-81 has shown significant anti-seizure activity across 34 preclinical models, demonstrating no development of pharmaco-resistance or tolerance [4][14] - The compound has also been effective in reducing epileptiform electrical activity in brain slices from treatment-resistant epileptic patients [4][15] Analgesic Properties - KRM-II-81 exhibits strong analgesic effects in various preclinical studies, comparable to or exceeding commonly used analgesics, without the side effects associated with opioids [5][16] - The compound does not induce tolerance, dependence, or respiratory depression, addressing concerns related to the opioid epidemic [5][16] Patent License Agreement - The Amended and Restated Patent License Agreement includes updates on regulatory milestone payments, royalty structures, and patent cost reimbursements [6][7] - The agreement aims to align with current commercialization strategies and eliminate prior equity provisions in favor of a fixed exit fee [6][7] Company Overview - RespireRx Group focuses on developing treatments for psychiatric and neurological disorders, including epilepsy, pain, ADHD, and obstructive sleep apnea [8][9] - The company holds exclusive licenses and patents for various chemical compounds targeting these conditions [9] Additional Programs - The company is also advancing its AMPAkines programs, which have shown promise in treating CNS-driven neurobehavioral and cognitive disorders [10][12] - ResolutionRx Ltd, a subsidiary, is developing a new formulation of dronabinol for obstructive sleep apnea, with a total budget of approximately $16.5 million [19][20]
RespireRx Pharmaceuticals Inc. Announces Commencement of Rule 506(c) Private Placement
Globenewswire· 2025-11-18 14:30
Core Viewpoint - RespireRx Pharmaceuticals Inc. is initiating a Regulation D, Rule 506(c) exempt offering of securities, targeting a raise of up to $45 million to support its research and development efforts across its affiliated entities [1] Summary of the Offering - The financing will support ongoing and future research and development and clinical programs across RespireRx, EndeavourRx LLC, and ResolutionRx Ltd [2] Capital Allocation and Use of Proceeds - The funds will be allocated as follows: - ResolutionRx Ltd: $15 million for advancing a proprietary dronabinol formulation for obstructive sleep apnea (OSA), including PK/PD studies and a Phase 3 clinical trial [5] - EndeavourRx LLC: $25 million for developing AMPAkines and GABAkines, with funding from the U.S. Department of Defense and NIH [5] - RespireRx Pharmaceuticals Inc.: $5 million for corporate operations and intellectual property management [5] About RespireRx Group - RespireRx Group focuses on developing treatments for psychiatric and neurological disorders, including epilepsy, ADHD, spinal cord injury recovery, and OSA [2][3] - The group is developing a pipeline of new and repurposed drug products based on two platforms: neuromodulators (AMPAkines and GABAkines) and pharmaceutical cannabinoids [2] EndeavourRx LLC: Neuromodulators - EndeavourRx has developed a family of AMPAkines, including CX717 and CX1739, which have shown potential in treating CNS-driven disorders and have completed Phase 1 safety trials [4][7] - The company is also focusing on GABAkines for treatment-resistant epilepsy and non-opioid pain, with promising preclinical results [9][10] ResolutionRx Ltd: Pharmaceutical Cannabinoids - ResolutionRx is developing a new formulation of dronabinol for OSA, targeting a large patient population with no approved drug treatments [14][15] - The total budget for the dronabinol program is approximately $16.5 million, with a significant portion expected to qualify for the Australian R&D Tax Incentive [14] Research and Development Achievements - KRM-II-81, a GABAkine, has shown high anti-convulsant activity in preclinical studies and does not develop tolerance, making it a potential treatment for epilepsy [10][11] - Dronabinol has demonstrated significant improvement in OSA symptoms in previous clinical trials, indicating its potential for repurposing [14][15]
RespireRx Pharmaceuticals Inc. Announces SEC Order Making Findings and Revoking Registration of Securities and Future Plans with respect to its Common Stock
Globenewswire· 2025-11-18 14:30
Core Viewpoint - RespireRx Pharmaceuticals Inc. has received an order from the Securities and Exchange Commission (SEC) revoking the registration of its securities due to non-compliance with reporting requirements under the Securities Exchange Act of 1934 [2][4]. Summary by Sections The Order - On November 13, 2025, the SEC issued an order revoking the registration of RespireRx's securities effective November 14, 2025, due to the company's failure to file periodic reports since September 30, 2023 [2][4]. Findings - The SEC found that unsolicited quotations of RespireRx's common stock were submitted on the Expert Market of the OTC Link ATS, and the company had not complied with Exchange Act 13(a) and related rules [4]. Background - RespireRx submitted an offer of settlement on September 30, 2025, and awaited the SEC's decision during the government shutdown from October 1 to November 12, 2025. The settlement was accepted without any monetary fine, leading to the revocation of the registration of its common stock [5]. Future Plans - The company plans to register its common stock and possibly other classes on Form 10 after December 31, 2025, which will require filing two years of audited financial statements. The Form 10 will become effective 60 days after filing, and the company will need to remain current with required periodic filings thereafter [6]. About RespireRx Group - RespireRx Pharmaceuticals Inc. and its subsidiaries focus on developing treatments for psychiatric and neurological disorders, including epilepsy, ADHD, and obstructive sleep apnea. The company is working on a pipeline of new and repurposed drug products based on its patent portfolios [8][9]. EndeavourRx LLC: Neuromodulators - EndeavourRx has developed a family of AMPAkines, including CX717 and CX1739, which have shown promise in treating CNS-driven disorders and have completed Phase 1 and Phase 2 clinical trials [10][11]. GABAkines - The company has in-licensed GABAkines for treating epilepsy and pain, with KRM-II-81 demonstrating significant anti-convulsant and analgesic activity in preclinical studies [13][14][15]. ResolutionRx Ltd: Pharmaceutical Cannabinoids - ResolutionRx is developing a new formulation of dronabinol for obstructive sleep apnea, with a total budget of approximately $16.5 million for the program. Dronabinol has shown significant improvement in OSA symptoms in previous trials [17][18].