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 [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, which would have been $10.3 million if not for a subscription receivable [31][32] 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 option [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 engaging with the payer community to adapt to changing treatment paradigms [12][15] - The company is focused on advancing drug development initiatives and planned clinic acquisitions to build long-term shareholder value [33] 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 leadership team is optimistic about the potential for accelerated drug approvals and the impact on addressing the national crisis of suicide [30][46] - The company believes it is better positioned than ever to build shareholder value and address mental health challenges [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 two approval pathways for its ketamine product [18][24] Q&A Session Summary Question: Can you clarify the DCS results with TMS and its unique position? - The company explained that DCS is a mixed agonist-antagonist and has shown to enhance neuroplasticity, which is critical for its effectiveness in combination with TMS [34][35] Question: What feedback have you received on the accelerated approval strategy for NRx 100? - The company indicated that they expect to hear about the CMPV this year and are preparing to file for accelerated approval with substantial real-world data [39][40] Question: How will you position Hope to become an early adopter of the 1D protocol? - The company has partnered with AMPA and is the first site in Florida to implement the 1D protocol, which is readily deployable [42][43] Question: What is your commercialization strategy for NRx 100 and 101? - The company plans to utilize medical science liaison functions for NRx 100 and anticipates building a sales force for NRx 101, with potential partnerships with larger commercial entities [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]

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]