Financial Data and Key Metrics Changes - For Q3 2025, the company reported a loss from operations of $4 million, compared to a loss of $3 million in Q3 2024, primarily due to increased R&D expenses of $800,000 and additional administrative expenses of $400,000 [30][31] - The company reported revenue for the first time in its history, approximately $240,000, reflecting only 22 days of revenue from a single clinic [31][32] - As of September 30, 2025, the company had approximately $7.1 million in cash and cash equivalents, with total cash potentially reaching $10.3 million [31] Business Line Data and Key Metrics Changes - The company has advanced its drug approval applications for Ketaphree, NRx 100, and NRx 101, and has expanded its NRx 101 pipeline [3][4] - The acquisition of Durra Medical has initiated revenue generation, with plans to grow from two clinics to six or more by year-end [12][32] - The company anticipates significant revenue growth from short-term multimodality treatments that are already reimbursed at higher levels [13] Market Data and Key Metrics Changes - The market for ketamine is projected at approximately $750 million, with the company aiming to provide a preservative-free formulation [23] - The estimated market for NRx 101, targeting suicidal bipolar depression, is in excess of $1 billion [28] Company Strategy and Development Direction - The company aims to transform the treatment of severe depression and PTSD through innovative therapies combining D-cycloserine and TMS [4][11] - The strategy includes expanding the network of interventional psychiatry clinics and enhancing shareholder value through drug development and clinic acquisitions [30][33] - The company is focused on addressing the national crisis of suicide and improving treatment options for mental health disorders [30] Management's Comments on Operating Environment and Future Outlook - Management views the recent quarter as a watershed moment in the treatment of severe depression and PTSD, with promising data supporting their therapies [4][11] - The company is optimistic about the FDA's receptiveness to accelerated approval applications for NRx 100 and NRx 101, especially given the significant unmet medical need [25][40] - The leadership team is actively engaging with military and veterans' affairs leaders to address suicide prevention [20][30] Other Important Information - The company holds rights to over 70 patents related to the use of D-cycloserine in treating depression and PTSD [7] - The FDA has granted breakthrough therapy designation for NRx 101, and the company is pursuing both NDA and ANDA pathways for its products [18][24] Q&A Session Summary Question: Can you clarify the unique benefits of DCS compared to ketamine in treatment? - Management explained that DCS acts as a mixed agonist-antagonist and enhances neuroplasticity, which may improve TMS effectiveness [34][35] Question: What is the procedure for using DCS in conjunction with TMS? - The company has an expanded access protocol for DCS, allowing physicians to access it for treatment while collecting data on outcomes [38] Question: What feedback has been received regarding the accelerated approval strategy for NRx 100? - Management indicated that they expect to hear about the CMPV this year and are preparing to submit real-world data to support their NDA filing [39][40] Question: How will the company ensure adequate supply if the FDA bans preservative-containing formulations? - The company has a manufacturing capacity that could meet the entire U.S. demand for ketamine, utilizing a blow-fill seal presentation for production [41] Question: What is the commercialization strategy for NRx 100 and NRx 101? - NRx 100 will likely require a medical science liaison approach, while NRx 101 may necessitate a sales force due to its specific target market [44][45]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported a loss from operations of $4 million, compared to a loss of $3 million in Q3 2024, primarily due to increased R&D expenses of $800,000 and additional administrative expenses of $400,000 [28][29] - The company generated revenue for the first time, approximately $240,000, reflecting only 22 days of operations from a single clinic [29][30] - As of September 30, 2025, the company had approximately $7.1 million in cash and cash equivalents, with total cash potentially reaching $10.3 million [29] Business Line Data and Key Metrics Changes - The company has advanced its drug approval applications for Ketaphree, NRx 100, and NRx 101, and has expanded its NRx 101 pipeline [3][4] - Hope Therapeutics, a subsidiary, initiated revenue generation with the acquisition of Durra Medical, and plans to expand from two clinics to six or more by year-end [12][26] Market Data and Key Metrics Changes - The market for ketamine is projected at approximately $750 million, with the potential for significant growth through the introduction of preservative-free formulations [21][22] - The estimated market for NRx 101, targeting suicidal bipolar depression, exceeds $1 billion [26] Company Strategy and Development Direction - The company aims to transform the treatment of severe depression and PTSD through innovative therapies combining D-cycloserine and TMS [4][10] - The strategy includes expanding clinic operations and integrating new treatment protocols to enhance patient outcomes and revenue growth [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, anticipating significant revenue growth as more clinics are integrated and additional acquisitions are pursued [12][30] - The leadership highlighted the importance of addressing the national crisis of suicide and the potential for their therapies to meet unmet medical needs [28][30] Other Important Information - The company holds rights to over 70 patents related to the use of D-cycloserine in treating various brain disorders [6] - The FDA has granted breakthrough therapy designation for NRx 101, and the company is pursuing accelerated approval pathways for its drug applications [22][36] Q&A Session Summary Question: Can you clarify the unique benefits of DCS compared to ketamine in treatment? - Management explained that DCS acts as a mixed agonist-antagonist and enhances neuroplasticity, which may improve the effectiveness of TMS [32][34] Question: What is the anticipated timeline for FDA feedback on accelerated approval? - The company expects to hear about the Commissioner's National Priority Voucher (CMPV) this year, which could impact the PDUFA timeline [36][37] Question: How will the company ensure adequate supply if the FDA bans preservative-containing formulations? - The company has a manufacturing process that allows for high production capacity, potentially supplying all required ketamine in the U.S. [38] Question: What is the commercialization strategy for NRx 100 and NRx 101? - NRx 100 will likely require a medical science liaison approach, while NRx 101 may necessitate a sales force due to its specific target market [40][41]

Core Insights - NRx Pharmaceuticals has made significant progress in advancing its corporate objectives and has entered revenue-generating activities for the first time in 2025 [2] - The company is focusing on two main products: NRX-100 for suicidal depression and NRX-101 for bipolar depression, with both products receiving regulatory designations to expedite their development [3][4] Financial Performance - For the quarter ended September 30, 2025, NRx Pharmaceuticals reported a loss from operations of $4.0 million, an increase from a loss of $3.0 million in the same quarter of 2024, primarily due to increased research and development expenses [14] - The company reported revenue of approximately $240,000 for the first time, driven by the acquisition of Dura Medical, which closed on September 8, 2025 [14] - As of September 30, 2025, the company had approximately $7.1 million in cash and cash equivalents, which would increase to $10.3 million after accounting for a subscription receivable [14][16] Product Development and Regulatory Updates - NRX-100 is being developed through both an NDA under FDA Fast Track designation and an ANDA for a preservative-free ketamine product, with the generic ketamine market estimated at approximately $750 million [3][6] - The NDA for NRX-100 is expected to be completed in Q4 2025, incorporating Real World Efficacy Data from over 60,000 patients [4] - NRX-101 has shown promising Real World Efficacy data, indicating that it can double the antidepressant and anti-suicidal effects of Transcranial Magnetic Stimulation (TMS) [10] Corporate Strategy and Expansion - HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is expanding its network of interventional psychiatry clinics, with three facilities currently operational in Florida and plans for more by year-end [6][12] - The company is actively pursuing additional acquisitions to enhance its clinic network, with potential revenue from these acquisitions estimated to exceed $20 million annually [15] - NRx Pharmaceuticals is also working on a nationwide expanded access program for NRX-101, allowing physicians to provide the medication at no charge to patients [10]

Regulatory Approvals and Designations - NRx Pharmaceuticals has received Fast Track Designation from the FDA for NRX-100, expanding the addressable market to approximately 13 million Americans, a tenfold increase compared to the previous designation for bipolar depression alone [261]. - The ANDA for NRX-100 was refiled in September 2025, with FDA communication on November 6, 2025, indicating no major deficiencies, anticipating approval in Q2 2026 [260]. - The NDA for NRX-100 is expected to be completed in Q4 2025, with real-world efficacy data from 65,000 patients being submitted to support the application [260]. - NRX-101 has received Breakthrough Therapy Designation from the FDA and is anticipated to be filed for Accelerated Approval for treatment of "Suicidal Bipolar Depression" [284]. Product Launches and Market Opportunities - The company aims to launch KETAFREE™ in Q1 2026, following the successful re-filing of the ANDA for preservative-free ketamine [260]. - The market for generic ketamine is estimated at $750 million, with expectations to enter this market in early 2026 [264]. - NRX-100 is expected to be used in millions of patients each year, with data supporting its efficacy in reducing suicidal ideation and depression [275]. Financial Performance - For the three months ended September 30, 2025, the Company's net loss was $5.9 million, compared to a net loss of $1.6 million for the same period in 2024 [298]. - For the nine months ended September 30, 2025, the Company's net loss was $29.0 million, up from $16.1 million in the same period in 2024 [298]. - As of September 30, 2025, the Company had an accumulated deficit of $307.3 million and a stockholders' deficit of $25.8 million [298]. - The Company recorded total revenue of approximately $0.2 million for the three and nine months ended September 30, 2025, solely from patient services provided by Dura following its acquisition [303]. - The Company anticipates that revenue will increase in subsequent periods as Dura's operations are fully integrated and additional clinical capacity is expanded [304]. Operating Expenses and Financial Obligations - Operating expenses for the three months ended September 30, 2025, totaled $4.3 million, up from $3.0 million in 2024, representing an increase of $1.2 million [311]. - Research and development expenses rose to $1.4 million for the three months ended September 30, 2025, compared to $0.6 million in 2024, an increase of $0.8 million attributed to clinical trials and consulting costs [314]. - General and administrative expenses increased to $2.8 million for the three months ended September 30, 2025, from $2.4 million in 2024, reflecting a $0.5 million rise primarily due to employee expenses [315]. - The Company plans to pursue additional equity or debt financing to fund ongoing clinical activities and meet obligations under current debt arrangements [299]. Acquisitions and Partnerships - HOPE Therapeutics became a revenue-generating clinical enterprise after acquiring Dura Medical, which offers precision-based interventional psychiatry services [258]. - The Company is in active acquisition mode and establishing partnerships with TMS providers to enhance its clinical footprint [296]. - The company has a contractual obligation to pay up to $3.0 million in contingent earn-out payments based on EBITDA performance following the acquisition of Dura [352]. Goodwill and Impairment Testing - Goodwill from the Dura acquisition is attributed to the assembled workforce, anticipated growth in the Florida region, and expected synergies from integrating the clinics into existing operations [367]. - Goodwill is subject to annual impairment testing, conducted on December 31st, or more frequently if impairment indicators arise [368]. - The impairment assessment of goodwill involves evaluating qualitative factors such as macroeconomic conditions, industry conditions, and overall financial performance of reporting units [369]. - If the carrying value of a reporting unit exceeds its fair value, the impairment amount recognized is the difference between the carrying amount and the fair value [370]. - Fair value estimates may utilize a discounted cash flow methodology, requiring significant judgment regarding future cash flows and discount rates [371]. Cash Flow and Financing Activities - The company generated net cash proceeds of approximately $6.1 million from the ATM Offering through September 30, 2025 [341]. - Net cash used in investing activities was $2.6 million for the nine months ended September 30, 2025, primarily related to the acquisition of Dura [346]. - Financing activities provided $18.7 million of cash during the nine months ended September 30, 2025, driven by proceeds from the issuance of Common Stock and warrants [347]. - The company expects to continue incurring significant operating losses for the foreseeable future and may never become profitable [339].

Core Points - NRx Pharmaceuticals, Inc. will release its third quarter 2025 financial results on November 17, 2025, before market opening [1] - A conference call will be held at 8:30am ET on the same day to provide corporate and financial updates [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [3] - The company is developing NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone [3] - NRX-100 has received Fast Track Designation for treating suicidal ideation in depression, including bipolar depression, while NRX-101 has been awarded Breakthrough Therapy Designation for suicidal bipolar depression [3] - NRx has recently re-filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100, applying for the Commissioner's National Priority Voucher Program [3]

Core Insights - HOPE Therapeutics has initiated patient care for treatment-resistant depression using the Ampa One Day (ONE-D) protocol, marking a significant advancement in TMS therapy [1][2] - The Ampa device has shown promising results with an 87% response rate and a 72% remission rate in nonrandomized trials when combined with D-cycloserine and lisdexamfetamine [1][5] - The ONE-D protocol reduces the treatment duration from 90 days to a single day, offering a new paradigm for patients suffering from severe depression [2][3] Company Overview - HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is focused on building a network of interventional psychiatry clinics that provide various therapies, including TMS and neuroplastic medications [4] - The company is expanding its presence in Florida, with plans to operate six clinic locations by the end of 2025 [2][5] - Dr. Rebecca Cohen, the Medical Director of HOPE, is the first Ampa-certified psychiatrist in Florida, leading the deployment of the Ampa device [5] Treatment Protocol - The ONE-D protocol combines TMS with physician-prescribed D-cycloserine and lisdexamfetamine, aiming to achieve remission from treatment-resistant depression [4][5] - D-cycloserine has been shown to enhance the effectiveness of TMS significantly, with studies indicating a more than two-fold increase in treatment efficacy [1][3] Research and Development - NRx Pharmaceuticals is developing NRX-100 and NRX-101, targeting central nervous system disorders, including suicidal depression and PTSD [5][6] - NRX-101 has received Breakthrough Therapy designation for treating suicidal bipolar depression, highlighting the company's commitment to addressing critical mental health issues [6]

Core Insights - HOPE Therapeutics, Inc. has acquired a strategic interest in Cohen and Associates, LLC, integrating it into the HOPE Network, with Dr. Rebecca Cohen appointed as Medical Director overseeing care standards in Florida [1][9] Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focusing on building a network of interventional psychiatry clinics offering treatments such as ketamine and Transcranial Magnetic Stimulation (TMS) for patients with suicidal depression and related disorders [7] - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal depression and PTSD, with products like NRX-100 and NRX-101 [6] Leadership and Expertise - Dr. Rebecca Cohen is a recognized expert in TMS and has a strong academic background, having founded her practice in 2014 as one of the first dedicated interventional psychiatry practices in the U.S. [3][9] - The leadership team at HOPE, including Dr. Cohen and Stephen Durand, RN, aims to advance interventional psychiatry and expand treatment options for patients [4][5] Strategic Goals - The acquisition of Cohen, LLC is expected to enhance HOPE Therapeutics' revenue and EBITDA, with immediate expansion plans in Western Florida and Palm Beach [9]

Summary of NRx Pharmaceuticals Conference Call (October 08, 2025) Company Overview - NRx Pharmaceuticals is a micro-cap biotechnology company focused on developing treatments for mental health conditions, particularly suicidal ideation and depression [3][4] Key Programs and Developments - **NRX-100**: An intravenous ketamine formulation aimed at treating suicidal ideation and depression, with a fast-track indication granted by the FDA. The company is engaging with the FDA for a new drug application (NDA) [4][3] - **Market Potential**: The addressable market for NRX-100 is estimated to exceed $2 billion, based on the efficacy data from clinical trials and real-world data from over 180,000 patients treated with ketamine [4] - **NRX-101**: A fixed-dose combination of D-cycloserine and lurasidone, which has received breakthrough therapy designation. It aims to reduce suicidality in patients with akathisia [5][6] - **Hope Therapeutics Clinics**: The company is establishing a network of clinics to integrate medications with neuroplastic therapies like transcranial magnetic stimulation (TMS) and hyperbaric oxygen therapy [6][8] Competitive Landscape - **Johnson & Johnson's S-ketamine**: The only approved nasal spray for depression, which does not lower suicidality. It generated $1.3 billion in sales last year [5] - **Market Dynamics**: There is a current market of $750 million for ketamine, which is often in chronic shortage, leading providers to compounding pharmacies [8] Clinical Insights and Data - **PTSD Treatment**: Recent studies indicate that intravenous ketamine significantly reduces PTSD symptoms, with 12 million Americans affected by PTSD and no approved drug available [8][9] - **Suicidality Statistics**: Over 50,000 Americans die by suicide annually, with significant numbers of individuals contemplating or attempting suicide [10] - **Neuroplasticity**: The company emphasizes the neurobiological understanding of suicidality, focusing on NMDA receptor antagonists to promote neuroplasticity and improve treatment outcomes [11][13] Regulatory and Strategic Initiatives - **FDA Engagement**: The company is pursuing a Commissioner's National Priority Voucher (CNPV) to expedite the NDA process for NRX-100, which could significantly shorten the timeline for approval [4][27] - **Citizen's Petition**: NRx Pharmaceuticals has filed a petition with the FDA to remove toxic preservatives from ketamine formulations [7] Future Directions - **Combination Therapies**: The company plans to integrate various treatment modalities, including neuroplastic drugs, TMS, hyperbaric oxygen therapy, and digital therapeutics, to create a comprehensive treatment approach for suicidal depression and PTSD [22][24] - **Cost-Effectiveness**: The treatment courses proposed by NRx Pharmaceuticals are expected to be significantly less expensive than traditional interventions for other serious health conditions, costing less than $10,000 [23] Government and Regulatory Support - **Administration Focus**: The current administration has prioritized mental health, particularly veteran suicide prevention, indicating a supportive environment for innovative treatments like those being developed by NRx Pharmaceuticals [24][25] Conclusion - NRx Pharmaceuticals is positioned to address critical gaps in the treatment of suicidal ideation and depression through innovative drug development and integrated therapeutic approaches, with significant market potential and supportive regulatory pathways ahead [3][4][22]

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference on October 8, 2025 [1][2] - The presentation will include a corporate update and plans to launch a low-dose D-Cycloserine product, which has shown to more than double the effectiveness of Transcranial Magnetic Stimulation in treating depression [2] - NRx Pharmaceuticals is actively involved in treating veterans with suicidal depression and PTSD, collaborating with the US Department of Veterans Affairs [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [4] - The company is developing NRX-100 (intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation and NRX-101 receiving Breakthrough Therapy Designation for treating suicidal bipolar depression [4] - NRx has recently re-filed an Abbreviated New Drug Application for NRX-100 and initiated a New Drug Application filing for the treatment of suicidal ideation in patients with depression [4] HOPE Therapeutics Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics [5] - The clinics will offer treatments such as ketamine, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy for patients with suicidal depression and related disorders [5] - HOPE Therapeutics aims to enhance the clinical benefits of NMDA-targeted drug therapy through a digital therapeutic-enabled platform [5]

Core Viewpoint - NRx Pharmaceuticals has re-filed its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free IV ketamine formulation, following FDA approval of its Suitability Petition for the proposed strength of the drug [1][6]. 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, a number that continues to rise due to increased clinical focus [2]. Company Developments - NRx Pharmaceuticals aims to capture a significant share of the ketamine market and is seeking priority review from the FDA due to a severe drug shortage [2][4]. - The company has filed a citizen's petition to remove benzethonium chloride (BZT), a neurotoxic substance, from ketamine formulations intended for intravenous use [3][6]. - NRx's KETAFREE™ formulation is designed to eliminate toxic preservatives, aligning with current health priorities to remove harmful substances from drugs [6][7]. Manufacturing and Regulatory Context - The manufacturing of KETAFREE™ is in partnership with Nephron Pharmaceuticals, supporting the U.S. initiative to reshore critical drugs [4][6]. - The ANDA formulation is distinct from the New Drug Application (NDA) for NRX-100, which has received Fast Track Designation for treating suicidal ideation in depression [5][6]. Clinical Data and Future Prospects - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients, demonstrating the efficacy of ketamine compared to placebo and electroconvulsive therapy [5][6].