Core Viewpoint - NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove Benzethonium Chloride from all forms of ketamine sold in the U.S. due to its known toxicity and lack of safety recognition by the FDA [1][2][6] Company Developments - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [3] - The company has filed an Abbreviated New Drug Application (ANDA) for a preservative-free ketamine and initiated a New Drug Application (NDA) for NRX-100 (IV ketamine) under the FDA's National Priority Voucher Program for treating suicidal depression [4] - NRx has demonstrated long-term stability and sterility for its preservative-free ketamine, which is crucial for its approval process [6] Industry Context - Benzethonium Chloride is a preservative that has been prohibited in hand cleansers and topical antiseptics by the FDA due to its toxicity [6] - The European Medicines Agency has also warned against the use of Benzethonium Chloride, indicating a growing concern over its safety in pharmaceutical products [2]

Company Overview - NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is developing NRX-101, which has been designated as an FDA Breakthrough Therapy for suicidal treatment-resistant bipolar depression, with plans to file a New Drug Application (NDA) for Accelerated Approval [4] Recent Developments - NRx Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine, for currently approved indications [5] - The company has initiated an NDA filing for NRX-100 for the treatment of suicidal depression, based on clinical trial results and new data from French health authorities [5] - NRx has received Fast Track Designation from the US FDA for the development of NRX-100 to treat patients with acute suicidality and has filed a patent for this novel formulation [5] Events and Collaborations - The CEO and Chairman of NRx Pharmaceuticals will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on July 29-30, 2025, discussing neuroplasticity in CNS disorder treatments [1][2] - The discussion will include insights from Prof. Samuel Wilkinson, a pioneer in the understanding of ketamine and other neuroplastic drugs for treating depression and PTSD [2] Subsidiary Information - HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, is establishing a network of interventional psychiatry clinics to provide ketamine and other therapies for suicidal depression and related disorders [6]

Core Viewpoint - HOPE Therapeutics, Inc. has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, LLC, a leading Interventional Psychiatry clinic in Florida, which is expected to enhance HOPE's clinical care capabilities in the region [1][2][8]. Company Overview - HOPE Therapeutics, Inc. is a subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics to provide treatments for suicidal depression and related disorders [8][9]. - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD [6]. Acquisition Details - The acquisition of Cohen is anticipated to be immediately accretive to revenue and EBITDA for HOPE Therapeutics [8]. - The transaction is subject to the execution of definitive documents and standard closing requirements, with further details to be disclosed later [5]. Cohen and Associates - Cohen and Associates, founded by Dr. Rebecca Cohen, is recognized for its comprehensive treatment options for suicidal depression, PTSD, and other CNS disorders, including ketamine and Transcranial Magnetic Stimulation (TMS) [2][3]. - Dr. Rebecca Cohen is an expert in mood and anxiety disorders, with a strong academic background and recognition in the field of TMS [3]. Leadership Statements - The leadership of HOPE Therapeutics expressed enthusiasm about the acquisition, highlighting Dr. Cohen's experience and commitment to patient care as a perfect fit for the company's mission [4][5].

Core Points - NRx Pharmaceuticals has filed for the FDA's newly announced Commissioner's National Priority Voucher program for its NRX-100, a preservative-free formulation of ketamine for intravenous use [1][7] - The FDA's new approval pathway aims to expedite the review process for drugs addressing national health priorities, reducing the review time from approximately 10-12 months to 1-2 months [2][3] - The FDA has identified suicidal depression and PTSD as national health crises, aligning with NRx's focus on innovative treatments for these conditions [5][9] Company Developments - NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of the application for NRX-100 and received FDA feedback [3][6] - The company is preparing a citizen petition to withdraw preservative-containing forms of ketamine due to toxicity concerns, which could enhance its market position in the $750 million generic ketamine market projected to reach $3-5 billion annually by 2033 [9][11] - NRx has received Fast Track Designation from the FDA for NRX-100, indicating its potential to address unmet medical needs [5][11] Market Context - The FDA plans to issue a limited number of vouchers in the first year of the CNPV program to companies that align with U.S. national health priorities [3][4] - NRx's innovative manufacturing approach aims to reduce reliance on foreign sources for ketamine supply, enhancing domestic drug manufacturing as a national security issue [4][8] - The company anticipates decisions on drug approval by year-end 2025, consistent with the timelines announced for the CNPV program [7][9]

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics have formed a strategic investor relations partnership with astr partners to enhance their visibility and investor engagement at a critical juncture in their development [1][2][3] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on 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 an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression, and plans to file for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine, and is also pursuing a New Drug Application for the treatment of suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a wholly-owned subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics that provide ketamine and transcranial magnetic stimulation (TMS) therapies [6] - The company aims to offer lifesaving therapies for patients with suicidal depression and related disorders, supported by a digital therapeutic-enabled platform [6] Strategic Partnership - The partnership with astr partners is expected to leverage their extensive experience in biotech investor relations and relationships with specialist investors to enhance NRx and HOPE's market presence [2][3] - The investor relations program will include investor targeting, message development, earnings preparation, conference support, and proactive engagement [3]

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics will participate in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025 [1][2] - Dr. Jonathan Javitt, CEO of NRx and Co-CEO of HOPE, will present the company's latest advancements, available on demand for registered attendees starting at 7:00 a.m. ET on June 16, 2025 [2][8] - The company will also engage in one-on-one meetings with investors during the conference [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is advancing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with plans to file an NDA for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application for NRX-100, a preservative-free IV ketamine, and is pursuing a New Drug Application for its use in treating suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on creating a network of interventional psychiatry clinics offering ketamine and other therapies for suicidal depression [6] - The company aims to enhance clinical benefits through a digital therapeutic-enabled platform that complements NMDA-targeted drug therapy [6]

Core Insights - NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine formulation, to the FDA for use in approved indications such as anesthesia and pain management [1][2] Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6] - An estimated 5.1 million Americans have received ketamine for medical uses, with demand continuing to rise due to increased clinical focus [2][6] - There is a severe drug shortage of ketamine in the U.S., which is not expected to improve in the near future [6] Company Developments - NRx Pharmaceuticals aims to capture a significant share of the existing ketamine market with its NRX-100 formulation, which eliminates the neurotoxic preservative benzethonium chloride [3][5] - The company plans to file a citizen's petition with the FDA to remove benzethonium chloride from all intravenous ketamine presentations [3][6] - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients to support the extension of ketamine's labeled indications to include treatment for suicidal depression [4][8] Regulatory and Patent Status - The FDA has granted a waiver of the $4.3 million NDA fee for NRX-100, recognizing its public health value [5] - NRX-100 has received Fast Track Designation from the FDA, and the company has filed a patent for this novel formulation, seeking protection until 2045 [5][8]

Financial Performance - For Q1 2025, NRx Pharmaceuticals reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, with a loss from operations of $3.8 million compared to $6.0 million in the prior year[21]. - NRx Pharmaceuticals raised $8.9 million in gross proceeds in January 2025 through a convertible debt offering and a registered direct equity offering, strengthening its balance sheet[18]. - Subsequent to Q1, the company signed financing agreements for $10.3 million in acquisition capital that is non-dilutive to shareholders[19]. - As of March 31, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents, with expectations to support operations through at least the end of 2025[21][22]. Drug Development and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for NRX-100 (preservative-free IV ketamine) in Q2 2025, with an expected PDUFA date in 2025, and has received a $4.3 million NDA submission fee waiver from the FDA[4][8]. - NRX-101 is on track for NDA submission under Accelerated Approval, with anticipated PDUFA date in 2025, supported by strong clinical data and manufacturing stability[13]. - The company has developed a novel formulation, HTX-100, which is expected to undergo clinical testing in 2025/2026 and aims for FDA approval in late 2026[11]. Market Opportunities - NRX-100 targets the over $3 billion market for suicidal depression in the US, while NRX-101 addresses a market estimated at over $2 billion for bipolar depression[12][14]. Strategic Acquisitions - HOPE Therapeutics is acquiring Kadima Neuroscience Institute, Dura Medical, and Neurospa TMS Holdings, expected to generate approximately $15 million in forward-looking pro forma revenues[16]. - The company is negotiating additional clinic acquisitions that could represent ~$20 million in potential pro forma revenue, aiming for a total of $100 million in forward-looking revenue by year-end 2025[17].

Financial Data and Key Metrics Changes - 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 [37] - Loss from operations decreased to $3.8 million from $6 million in the same quarter last year [37] - Research and development expenses were $800,000, down from $1.7 million in Q1 2024, while general and administrative expenses decreased to $2.9 million from $4.3 million [37][38] Business Line Data and Key Metrics Changes - NRx has advanced its lead candidates, NRx 100 and NRx 101, in the regulatory process with the US FDA, aiming for revenue generation in the near term [6][10] - The company has established a network of clinics under Hope Therapeutics, which is expected to be revenue-generating and profitable soon [10][34] - The company anticipates clinic revenue well before the end of the year, with a focus on non-dilutive financing for clinic acquisitions [7][17] Market Data and Key Metrics Changes - The market for NRx 100, an intravenous preservative-free ketamine for treating suicidal depression, is projected to be significant, with potential sales reaching billions [27][26] - The company expects the market for NRx 101, targeting bipolar depression with suicidality or akathisia, to exceed $2 billion initially and potentially over $5 billion broadly [33][28] Company Strategy and Development Direction - NRx aims to address the national epidemic of suicidality, depression, and PTSD through innovative medicines and direct patient care via Hope Therapeutics [6][10] - The company plans to establish a national network of interventional psychiatry clinics, combining neuroplastic treatments and protocols [33][34] - NRx is focused on gaining FDA approval for its products to expand patient access and improve treatment options for mental health conditions [26][39] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increased focus from the US government on treating suicidal depression and PTSD, particularly in military and veteran communities [9] - The company is optimistic about its path to revenue generation and profitability by the end of 2025, supported by ongoing financing discussions and partnerships [38][36] - Management expressed confidence in the potential for NRx 100 and NRx 101 to provide life-saving treatments and significant market opportunities [27][39] Other Important Information - NRx has filed a patent for its novel preservative-free formulation of NRx 100, potentially protecting the product until 2045 [11][23] - The company has manufacturing capacity to supply over 1 million doses of ketamine per month upon FDA approval [11][22] - NRx is navigating the complexities of acquiring medical treatment facilities under state regulations as part of its growth strategy [16][34] Q&A Session Summary Question: What does the recent IP buy you if approved? - Management indicated that the strength of the patent application is believed to be strong, potentially providing market exclusivity for an extended period if the preservative-free ketamine is approved [41][42] Question: Consideration for NRx 100 going international? - Management confirmed intentions to make NRx 100 available internationally, noting that European countries are more sensitive to toxic substances, which could enhance market potential [47]

Financial Data and Key Metrics Changes - 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, and a loss from operations of $3.8 million compared to a loss of $6 million in the same quarter last year [33] - Research and development expenses were $800,000, down from $1.7 million in Q1 2024, while general and administrative expenses decreased to $2.9 million from $4.3 million [33] - As of March 31, 2025, the company had approximately $5.5 million in cash and cash equivalents, with expectations that current capital and ongoing financing discussions will support operations through at least the end of 2025 [33] Business Line Data and Key Metrics Changes - NRx Pharmaceuticals is advancing its lead candidates, NRx 100 and NRx 101, in the regulatory process with the FDA, aiming for revenue generation in the near future [5][9] - The company has initiated the filing of a New Drug Application (NDA) for NRx 100, a preservative-free intravenous ketamine for treating suicidal depression, supported by data from four well-controlled clinical trials [9][16] - NRx 101, a fixed-dose oral combination for treating suicidal depression, is also preparing for NDA filing, with expectations for accelerated approval due to its unique efficacy profile [11][28] Market Data and Key Metrics Changes - The market for NRx 100 is projected to be significant, with the current market for intranasal ketamine expected to generate $1.3 billion in sales for J&J's SPRAVATO, which does not demonstrate antisuicidal properties [24] - The potential market for NRx 101 in bipolar depression is estimated to exceed $2 billion for the initial indication, with the broader bipolar market potentially exceeding $5 billion [29] Company Strategy and Development Direction - The company is focused on establishing a national network of clinics through its subsidiary, Hope Therapeutics, to provide integrated care for patients with suicidality, depression, and PTSD [12][29] - NRx aims to create a comprehensive treatment model combining NMDA antagonist drugs with neuroplastic therapies, anticipating that integrated therapies could lead to sustained remission rates approaching 90% [13][14] - The company plans to expand its clinic network, having signed agreements to acquire several interventional psychiatry practices, with a goal of generating significant revenue from these clinics [30][31] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increasing focus from the U.S. government on treating suicidal depression and PTSD, particularly in military and veteran communities, which aligns with the company's mission [8] - The company anticipates becoming a revenue-generating entity by early next year if it continues to execute its plans effectively [15] - Management expressed confidence in the potential for NRx 100 and NRx 101 to address significant unmet medical needs in mental health treatment [35] Other Important Information - The company has filed a patent for its novel preservative-free formulation of NRx 100, potentially protecting the product until 2045 [10][20] - NRx has manufacturing capacity to supply over 1 million doses of ketamine per month, should it gain FDA approval [10][20] Q&A Session Summary Question: What does the recent IP buy you if approved? - Management indicated that the strength of the patent application is believed to be strong, and having a preservative-free ketamine could provide market exclusivity for an extended period [39][41] Question: Consideration for NRx 100 going international? - Management confirmed intentions to make NRx 100 available internationally, noting that European countries are more sensitive to toxic substances, which could enhance its market potential [43]