Summary of NRx Pharmaceuticals Update Call Company Overview - **Company**: NRx Pharmaceuticals (NasdaqCM:NRXP) - **Date of Call**: December 02, 2025 Key Points Regulatory Updates - NRx Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) for a preservative-free formulation of ketamine named **Ketaphree** to the FDA, which has accepted the filing for review with a goal date of **July 29, 2026** for completion [4][9][10] - Ketaphree is the first preservative-free ketamine formulation, eliminating **benzethonium chloride (BZT)**, which is not recognized as safe by the FDA [5][9] - The company has filed a citizens' petition to remove BZT from all commercial presentations of ketamine, citing toxicity concerns [5][9] Market Potential - The global market for ketamine is approximately **$750 million** annually, with compounded ketamine sales in the U.S. due to a shortage of manufactured products [7][11] - If the ANDA is approved and the citizens' petition is successful, NRx expects to capture a substantial market share, potentially increasing revenue significantly in the second half of **2026** [8][9][10] Manufacturing Capabilities - NRx has manufactured three commercial lots of Ketaphree and aims to produce **one million doses per month** using modern blow-fill-seal technology [10][11] - The company has sufficient active pharmaceutical ingredient (API) supply for five years, allowing for scalability in manufacturing [20] Pipeline Developments - NRx is developing **NRx-101**, a combination of D-cycloserine and lurasidone for treating suicidal bipolar depression, which has received Breakthrough Therapy Designation from the FDA [12][14] - Recent studies show that low-dose D-cycloserine combined with transcranial magnetic stimulation (TMS) resulted in an **87% clinical response** and **72% remission** from depression and suicidality [12][14][25] - The market estimate for NRx-101, if approved, exceeds **$1 billion** [14] Clinical Trials and Future Plans - A confirmatory phase three trial for NRx-101 is planned for early **2026**, focusing on its efficacy in augmenting TMS effects [22][28] - The trial will utilize both objective and subjective measures of depression, enhancing the reliability of results [29] Industry Context - The psychiatry field is moving away from SSRIs, which have low efficacy (around **30%**) and significant side effects, towards innovative treatments like TMS and NRx-101 [23][24] - TMS is gaining recognition as a viable treatment option, with reported response rates of **50-60%** without D-cycloserine [24] Closing Remarks - NRx Pharmaceuticals is optimistic about the ANDA filing and the expansion of its pipeline, aiming to deliver safer treatment options for patients and value for shareholders [32] Additional Important Information - The FDA's recognition of ketamine as a national priority drug emphasizes the importance of U.S. manufacturing of this critical medicine [10][21] - NRx has launched a nationwide expanded access program for NRx-101, allowing physicians to provide the medication at no charge to patients [14]

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]