Core Viewpoint - HOPE Therapeutics, Inc. is hosting an investor event to discuss strategic initiatives and progress in their clinical pipeline, emphasizing their commitment to mental health innovation [1][2][4]. Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focusing on building a network of interventional psychiatry clinics to provide innovative treatments for suicidal depression and related disorders [7]. - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain [5]. Strategic Initiatives - The investor event will cover expansion plans for HOPE's network of clinics and updates on NRx's clinical pipeline [2][4]. - Recent acquisitions of HOPE clinics are aimed at scaling the interventional psychiatry network [8]. Clinical Developments - NRx is preparing to file a New Drug Application (NDA) for NRX-100 (IV ketamine) for treating suicidal depression, following a $4.3 million filing fee waiver from the FDA [6][8]. - NRX-101 has received Breakthrough Therapy Designation and is set for an NDA filing for Accelerated Approval in patients with bipolar depression and suicidality or akathisia [5][8]. Technological Integration - Plans include integrating digital health solutions, such as CRM-based technology and telepsychiatry, to enhance clinical operations across the HOPE network [8].

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 ...

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].

Core Viewpoint - NRx Pharmaceuticals, Inc. (NRXP) has experienced a recent decline in share price, but the formation of a hammer chart pattern suggests a potential trend reversal due to increased buying interest and bullish sentiment among analysts [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure and a shift in control from bears to bulls [2][5]. - This pattern is characterized by a small candle body with a long lower wick, signifying that despite a downtrend, buying interest has emerged to push the stock price up towards the opening price [4][5]. Fundamental Analysis - There has been a significant upward trend in earnings estimate revisions for NRXP, with a 25% increase in the consensus EPS estimate over the last 30 days, indicating improved earnings expectations from analysts [7][8]. - The strong agreement among Wall Street analysts regarding the company's earnings prospects enhances the bullish case for NRXP [2][7]. Zacks Rank - NRXP currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9]. - A Zacks Rank of 2 serves as a strong indicator of a potential trend reversal, suggesting that the company's prospects are improving [9].

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 ...

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million or 33.5% to $18.5 million from $27.8 million for the year ended December 31, 2023 [30] - Research and development expense decreased by approximately $7.2 million or 53.6% to $6.2 million compared to $13.4 million for the year ended December 31, 2023 [30] - General administrative expense for the year ended December 31, 2024, decreased by approximately $7.7 million to $13.5 million compared to $14.2 million for the year ended December 31, 2023 [31] Business Line Data and Key Metrics Changes - NRx is advancing its drug development pipeline with the NDA filing for NRX100, a preservative-free intravenous ketamine, and anticipates an accelerated NDA filing for NRX101, a fixed-dose combination of desexeserin and lurasidone [7][19] - The company has proven manufacturing capacity to supply more than 1,000,000 doses of NRX100 per month upon FDA approval [7] - Hope Therapeutics is focused on delivering clinical care and has signed non-binding letters of intent to acquire three profitable interventional psychiatry clinics [9][10] Market Data and Key Metrics Changes - The market for intranasal esketamine is approximately $1 billion, with NRX100 expected to expand access to ketamine treatments for a broader patient population [18] - The estimated market for NRX101, targeting bipolar depression, is over $2 billion, with the broader bipolar market potentially exceeding $5 billion [24] Company Strategy and Development Direction - NRx aims to transition from a research-focused company to a healthcare provider capable of generating revenue and achieving profitability by the end of 2025 [5][6] - The company plans to build a national network of interventional psychiatry centers through Hope Therapeutics, combining various treatment modalities [25][27] - NRx is focused on addressing the unmet needs in the treatment of suicidality, depression, and PTSD, leveraging new drug applications and clinic acquisitions [10][11] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increased commitment from the U.S. government to treat mental health conditions, which aligns with NRx's mission [6] - The company is optimistic about its path to profitability, supported by reduced operating expenses and anticipated revenue from Hope Therapeutics [28] - Management expressed confidence in the potential for significant market opportunities with the upcoming drug approvals and clinic acquisitions [28][66] Other Important Information - NRx has raised nearly $20 million in financing and is exploring additional funding options for Hope Therapeutics [28] - The company is filing a citizen's petition with the FDA to remove ketamine preparations containing benzatholium chloride from the market until safety can be demonstrated for repeated use [15] Q&A Session Summary Question: How does removing the preservative from ketamine change the formulation? - Management explained that the preservative was originally included for multi-use vials, but with single-use vials, it is unnecessary [35][36] Question: Can you discuss the acquisition strategy for clinics? - Management indicated that Florida is a focus area, with plans to acquire clinics that effectively combine ketamine treatment with other therapies [41][42] Question: What is the status of the potential ketamine deal? - Management confirmed interest from commercial partners and expressed hope for a deal announcement in the near future [46][56] Question: How will the ANDA and NDA submissions be handled at the FDA? - Management clarified that the NDA is for adding depression indications to the ketamine label, while the ANDA is for a preservative-free version of the existing drug [52][53] Question: What are the expected revenues from the clinics being acquired? - Management confirmed that the clinics targeted for acquisition are expected to have run rates of about $5 million or larger [59]