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]

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]