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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports First Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-05-15 20:03
Core Insights - NRx Pharmaceuticals has reported continued momentum into 2025, advancing regulatory filings for NRX-100 and NRX-101, and enhancing its commercial opportunities with new intellectual property protection for NRX-100 [1][5] - The company is focused on expanding its HOPE Therapeutics network of interventional psychiatry clinics, with planned acquisitions aimed at addressing mental health treatment needs [1][14] Key Research and Development and Corporate Activities - NRX-100, a preservative-free IV ketamine for suicidal depression, aims to address a significant public health crisis, with over 13 million adults in the U.S. considering suicide annually [2] - The company has completed stability and sterility assays for NRX-100, demonstrating three years of room temperature shelf stability, and is on track for a New Drug Application (NDA) submission in Q2 2025 [3] - An Abbreviated New Drug Application (aNDA) for existing ketamine indications is planned for Q2 2025, based on the belief that preservative-free formulations will be preferred [4] - The FDA has waived the $4.3 million NDA submission fee for NRX-100, recognizing its public health benefits and small business status [5] - NRX-101, an oral treatment for suicidal bipolar depression, is progressing towards NDA submission with anticipated PDUFA dates in 2025, supported by strong clinical trial data [12][13] Financial Overview - For Q1 2025, the company reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, with operational losses also reduced [21] - As of March 31, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents, with ongoing financing discussions expected to support operations through the end of 2025 [22] HOPE Therapeutics Expansion - HOPE Therapeutics is developing a national network of clinics focused on neuroplastic therapies for treating depression and related conditions, with initial acquisitions expected to generate approximately $15 million in pro forma revenues [14][16] - The company is negotiating additional clinic acquisitions that could represent around $20 million in potential pro forma revenue [17] - Financing agreements totaling $10.3 million have been signed to support these acquisitions, which are non-dilutive to NRx shareholders [19][20]
HOPE Therapeutics, Inc. a subsidiary of NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Signing of Term Sheet for $7.8 Million Debt Financing to Fuel HOPE Clinic Acquisitions
Prnewswire· 2025-05-15 14:15
Core Insights - HOPE Therapeutics, Inc. has signed a term sheet with Universal Capital, LLC to secure $7.8 million in acquisition capital for expanding its network of interventional psychiatry clinics, aiming for a total of $10.3 million in acquisition capital through additional funding [1][8] Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on establishing a network of clinics that provide neuroplastic treatments, including ketamine and transcranial magnetic stimulation (TMS), for severe depression and PTSD [2][6] - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including NRX-101, which is designated as a Breakthrough Therapy by the FDA for suicidal treatment-resistant bipolar depression [7][9] Industry Context - Neuroplastic treatments are gaining recognition for their effectiveness in treating severe depression and PTSD, with clinical trials demonstrating their ability to foster new synaptic connections in the brain [2][3] - The U.S. Department of Veterans Affairs has highlighted the importance of psychedelic treatments, such as ketamine, in addressing veteran suicide, indicating a growing acceptance of these therapies in mainstream mental health care [3][4] Financial Strategy - The funding from Universal Capital is part of a broader strategy to acquire best-in-class clinics, with plans for future funding as additional assets are identified [4][8] - The company aims to address the mental health crisis in the U.S., where over 13 million Americans plan to commit suicide each year, emphasizing the urgent need for effective treatment options [4]
HOPE Therapeutics, Inc. and NRx Pharmaceuticals (NASDAQ:NRXP) Announce Signing of Definitive Agreement to Purchase Kadima Neuropsychiatry Institute; Foundational Acquisition for the HOPE Network of Interventional Psychiatry Clinics
Prnewswire· 2025-05-13 12:03
Core Insights - HOPE Therapeutics, Inc. has signed a definitive agreement to acquire Kadima Neuropsychiatry Institute, which will serve as a clinical model for HOPE's treatment offerings and continue its role in neuroplastic therapy research [1][4][6] - Kadima is recognized as a leading interventional psychiatry clinic in California, known for pioneering ketamine treatment for CNS disorders and is profitable with expected growth [2][6] - Dr. David Feifel, a prominent figure in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer, enhancing the company's leadership in mental healthcare [3][6] Company Overview - NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for CNS disorders, including suicidal bipolar depression and PTSD, with its investigational drug NRX-101 designated as a Breakthrough Therapy by the FDA [5][6] - HOPE Therapeutics aims to build a network of interventional psychiatry clinics offering treatments such as ketamine and TMS, supported by a digital therapeutic platform [8] Strategic Implications - The acquisition of Kadima is expected to be accretive to revenue and EBITDA for both NRx and HOPE, indicating a positive financial outlook post-acquisition [6] - The integration of Kadima's expertise and clinical model is aligned with HOPE's strategy to redefine mental healthcare access and delivery [4][6]
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Investor Event at Mar-A-Lago Club on May 8, 2025
Prnewswire· 2025-05-06 12:03
MIAMI, May 6, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a medical and technology-driven company and wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx" or the "Company") (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today announced that it will host an investor event at the Mar-A-Lago Club in Palm Beach, Florida, on Thursday, May 8, 2025, at the invitation of club members. HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) This discussion is being held to ...
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine
Prnewswire· 2025-05-05 12:03
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]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics™, Inc.to Participate in an H.C. Wainwright @ Home Fireside Discussion on Tuesday, April 22, 2025
Prnewswire· 2025-04-21 12:01
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].
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Signing of a Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into HOPE
Prnewswire· 2025-04-03 12:03
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 ...
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Definitive Purchase Agreement with Dura Medical; Initial Acquisition for Planned International Network of Interventional Psychiatry Clinics
Prnewswire· 2025-03-31 12:02
Core Viewpoint - HOPE Therapeutics, Inc. has signed a definitive agreement to acquire Dura Medical, enhancing its interventional psychiatry network on Florida's west coast, with Dura being revenue-generating and EBITDA positive [1][9]. Company Overview - HOPE Therapeutics is focused on developing a network of interventional psychiatry clinics that utilize psychedelic medications, including ketamine and Spravato®, combined with Transcranial Magnetic Stimulation (TMS) and other therapies for patients with suicidal depression and related disorders [7]. - NRx Pharmaceuticals, the parent company of HOPE, is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain [8]. Acquisition Details - Dura Medical, founded in 2018, specializes in a precision approach to treating mental health and chronic pain, offering services such as Ketamine Infusion Therapy and TMS [2][9]. - The acquisition is expected to provide comprehensive services to patients and is part of HOPE's strategy to expand its operations in Florida [1][9]. - The intended closing of the acquisition is subject to financial audits, regulatory approvals, and standard closing conditions [6]. Leadership and Mission - Stephen Durand, the founder of Dura Medical, will serve as the Director of Florida Clinic Operations for HOPE, emphasizing the mission to reduce suicide rates and treat over 10,000 individuals by 2026 [4][3]. - The collaboration aims to integrate Dura's commitment to patient care for both civilians and veterans into HOPE's network [5][9]. Services Offered - Dura Medical provides a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and TMS, catering to both veteran and civilian patients [9]. - The clinics utilize advanced interventional psychiatry procedures to address various mental health issues, including depression, suicidality, PTSD, and anxiety [2]. Future Plans - HOPE Therapeutics plans to expand its service offerings and enhance its operational capabilities through the acquisition of Dura Medical and the previously announced Neurospa network [1][9]. - The company is also pursuing the development of NRX-101, an investigational therapy for suicidal treatment-resistant bipolar depression, with plans to file for Accelerated Approval [8][10].
Here's Why NRx Pharmaceuticals (NRXP) Is a Great 'Buy the Bottom' Stock Now
ZACKS· 2025-03-27 14:55
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 ...
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Signing of Binding Letter of Intent with Neurospa TMS Holdings, LLC for Expansion of its Planned International Network of Interventional Psychiatry Clinics
Prnewswire· 2025-03-24 12:02
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., ( ...