Core Viewpoint - NRx Pharmaceuticals has filed a patent application for NRX-100, a preservative-free intravenous ketamine formulation aimed at treating suicidal depression, which could provide exclusivity until 2045 if granted [1][2][8] Group 1: Product Development - NRX-100 is specifically designed without benzethonium chloride or other preservatives, addressing safety concerns associated with these compounds [2][8] - The formulation demonstrates room temperature shelf stability without toxic excipients, potentially allowing it to be listed in the FDA Orange Book [2][8] - The company has initiated a New Drug Application (NDA) filing for NRX-100 based on clinical trial results and data from French health authorities [5] Group 2: Regulatory and Market Strategy - NRx Pharmaceuticals has received Fast Track Designation from the FDA for NRX-100, facilitating its development for patients with acute suicidality [5] - The company is committed to delivering safer treatments for suicidal depression, reflecting a focus on patient well-being [3] - The recent FDA fee waiver is expected to aid in the timely completion of the NDA submission [3] Group 3: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain [4] - The company is also developing NRX-101, which has been designated as an investigational Breakthrough Therapy by the FDA [4]

Core Viewpoint - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics will participate in an H.C. Wainwright fireside discussion on April 22, 2025, focusing on their developments in the biopharmaceutical and interventional psychiatry sectors [1][2][8]. Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4]. - The company is advancing NRX-101, which has received FDA designation as a Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with plans to file a New Drug Application for Accelerated Approval [4]. - NRx has also initiated the filing of a New Drug Application for NRX-100 (IV ketamine) for treating suicidal depression, supported by clinical trial results and data from French health authorities [5]. HOPE Therapeutics Overview - HOPE Therapeutics is a development stage healthcare delivery company aiming to create a network of interventional psychiatry clinics offering ketamine and transcranial magnetic stimulation (TMS) therapies for patients with suicidal depression [6]. - The company plans to integrate a digital therapeutic platform to enhance the clinical benefits of NMDA-targeted drug therapies [6].

Investment to support initiation of HOPE's network of clinics to treat suicidal depression and PTSD with ketamine, TMS and other modalities MIAMI, April 3, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq:NRXP), today announced signing of a term sheet with a global medical device manufacturer, as anticipated in the Company's recently filed annual report. The investor shares HOPE's vision of ...

MIAMI, March 31, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced signing of a definitive Agreement to acquire Dura Medical (Dura), per the previously announced non-binding Letter of Intent. Dura, together with the previously announced Neurospa network, are anticipated to provide a comprehensive service offering to patients on Florida's west coast. Dura is revenue gene ...

Shares of NRx Pharmaceuticals, Inc. (NRXP) have been struggling lately and have lost 5.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullis ...

Neurospa currently operates six interventional psychiatry clinics on Florida's Gulf Coast HOPE to acquire majority interest in Neurospa for a combination of cash and equity Neurospa clinics deliver a full range of interventional psychiatry services, including Ketamine, Spravato® and Transcranial Magnetic Stimulation (TMS) to patients with severe depression and related conditions Acquisition to be accretive to HOPE revenue projections for 2025 MIAMI, March 24, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ( ...

Financial Performance - NRx Pharmaceuticals reported a reduction in operational loss by approximately $2.0 million to $2.4 million for Q4 2024, a nearly 45% improvement compared to Q4 2023[23]. - For the year ended December 31, 2024, the company reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million from $27.8 million in 2023[24]. - NRx Pharmaceuticals has completed financing agreements totaling $10.9 million in 2024 and $8.5 million in January 2025 to support ongoing operations and clinic expansions[20][25]. - Management forecasts potential profitability on a forward-looking run-rate basis by year-end 2025, although no assurances can be given[3]. Research and Development - Research and development expenses decreased by approximately $1.5 million to $1.0 million in Q4 2024, down from $2.5 million in Q4 2023, primarily due to the conclusion of the phase 2b/3 study for NRX-101[23]. - NRx has initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression[30]. - NRx was awarded Fast Track Designation by the US FDA for the development of ketamine (NRX-100) to treat patients with acute suicidality[30]. Product Development and Licensing - The anticipated PDUFA date for the NDA filing of NRX-100 is prior to December 31, 2025, targeting the $3 billion Suicidal Depression market in the US[6][7]. - The company has accepted non-binding terms for licensing NRX-100, which includes over $300 million in potential milestones plus tiered double-digit royalties based on net sales[3][7]. - NRx Pharmaceuticals plans to file an ANDA for preservative-free ketamine in Q2 2025, aiming to address all currently indicated human and veterinary applications[9]. Strategic Growth and Acquisitions - The company aims to acquire 15-20 psychiatry clinics in Florida by year-end 2025, with each clinic currently generating approximately $5 million in revenue[19][18]. - The company is negotiating terms with a strategic investor for capital to support further HOPE clinic acquisitions, enhancing its interventional psychiatry services[3][21]. - HOPE Therapeutics aims to develop a network of interventional psychiatry clinics offering ketamine TMS and other therapies for suicidal depression[31]. - HOPE Therapeutics is focused on acquiring providers for its national network and raising adequate capital for these acquisitions[32]. - The company intends to spin-off HOPE Therapeutics as part of its growth strategy[32]. Risks and Forward-Looking Statements - The company acknowledges risks and uncertainties that may affect future financial performance and operational results[32]. - Investors are encouraged to review the company's most recent Annual Report on Form 10-K for detailed risk factors[32]. - The company does not assume any obligation to update forward-looking statements unless required by law[32]. Management - Matthew Duffy serves as Chief Business Officer of NRx Pharmaceuticals and Co-Chief Executive Officer of HOPE Therapeutics[33].

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q4 2024 Earnings Conference Call March 17, 2025 8:30 AM ET Company Participants Matthew Duffy - Chief Business Officer Jonathan Javitt - Founder, Chairman and Chief Scientist Michael Abrams - Chief Financial Officer Conference Call Participants Jason Kolbert - D. Boral Capital Thomas Shrader - BTIG Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and Full Year 2024 Ea ...

NRx Pharmaceuticals (NRXP) Q4 2024 Earnings Call March 17, 2025 08:30 AM ET Company Participants Matthew Duffy - Chief Business Officer & Co-CEO of Hope TherapeuticsJonathan Javitt - Founder, Chairman, and CEOMichael Abrams - CFOJason Kolbert - Managing DirectorVernon Bernardino - Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystEdward Woo - Director of Research & Senior Analyst Operator Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and F ...

Core Insights - NRx Pharmaceuticals has made significant advancements in its drug development and business strategy, including the filing of a New Drug Application (NDA) for NRX-100, aimed at treating Suicidal Depression, and progress towards NDA for NRX-101 for bipolar depression [1][4][28] - The company has successfully reduced operational losses and improved financial metrics, indicating a positive trend in cost management and operational efficiency [22][23] Financial Results - For Q4 2024, the company reduced its loss from operations by approximately $2.0 million to $2.4 million, a nearly 45% improvement compared to Q4 2023, primarily due to lower research and development costs [22] - For the full year 2024, the loss from operations decreased by approximately $9.3 million, or 33.5%, to $18.5 million, driven by a significant reduction in research and development expenses [23] - As of December 31, 2024, the company had approximately $1.4 million in cash and cash equivalents, with additional financing completed in January 2025 totaling approximately $8.5 million [24][19] Research and Development Activities - The company has initiated the NDA filing for NRX-100, a preservative-free IV ketamine formulation for Suicidal Depression, with an anticipated PDUFA date prior to December 31, 2025 [3][4] - NRX-101 is also moving towards NDA submission for Accelerated Approval, targeting bipolar depression in patients at risk of akathisia, with a similar PDUFA timeline [11][12] - The company is developing a novel pH neutral formulation of ketamine (HTX-100) for both intravenous and subcutaneous administration, expected to undergo clinical testing in 2025/2026 [8] Strategic Initiatives - NRx Pharmaceuticals is negotiating potential licensing agreements for NRX-100 that could yield over $300 million in milestones and tiered royalties [5][4] - The company is actively pursuing acquisitions to expand its HOPE Therapeutics network, aiming to establish a national network of interventional psychiatry clinics [15][17] - A leading regulatory law firm has been retained to file a citizen's petition to remove toxic preservatives from ketamine formulations, aligning with evolving federal policies [9][6] Market Potential - The market for Suicidal Depression in the US is estimated to exceed $3 billion, while the bipolar depression market could exceed $5 billion [5][12] - The company believes that the preservative-free feature of NRX-100 will be beneficial to patients and is consistent with federal policy changes regarding toxic substances in drug formulations [7][9]