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]