ONE-D is the first reported protocol to achieve remission from treatment-resistant depression with a single day of treatment, using an FDA-cleared device.HOPE is one of the first Ampa deployments nationwide and is now deployed at multiple HOPE locations in Florida, including Naples, Fort Myers, and Sarasota, with six locations planned by year-end 2025.HOPE Medical Director, Rebecca Cohen, MD, is first Ampa-certified psychiatrist in Florida. Ampa Health has reported nonrandomized results indicating 87% respo ...

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].

Core Viewpoint - NRx Pharmaceuticals has received FDA approval for a Suitability Petition for its preservative-free ketamine product, KETAFREE™, allowing for the re-filing of its Abbreviated New Drug Application, which aligns with U.S. policy objectives to re-shore important drugs and eliminate toxic preservatives [1][6]. Group 1: Product Development - The proposed KETAFREE™ product aims to replace the current multi-dose vials of ketamine that contain toxic preservatives, addressing safety concerns [1][6]. - NRx Pharmaceuticals is also developing NRX-100, a non-generic formulation of ketamine intended for treating suicidal depression and PTSD, under a separate New Drug Application [2][4]. Group 2: Market Potential - The current market for ketamine is estimated at $750 million, and the company believes KETAFREE™ will be a successful addition to this market [2]. Group 3: Regulatory Engagement - NRx Pharmaceuticals was selected to attend a listening session hosted by the FDA Commissioner for biotechnology CEOs, indicating strong engagement with regulatory authorities [3]. - The rapid response from the FDA regarding the Suitability Petition is seen as a positive sign for the company's future product launch [3]. Group 4: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression and PTSD [4]. - The company has received Fast Track Designation for NRX-100 and Breakthrough Therapy Designation for NRX-101, highlighting its commitment to addressing critical mental health issues [4].

Summary of NRx Pharmaceuticals FY Conference Call Company Overview - **Company**: NRx Pharmaceuticals (NasdaqCM:NRXP) - **Focus**: Advancing neuropsychiatric treatments addressing high unmet medical needs - **Lead Programs**: - **NRX-100**: IV preservative-free ketamine formulation for suicidal depression - **NRX-101**: Oral combination of d-cycloserine and lurasidone targeting bipolar depression with suicidality or akathisia - **Future Plans**: Establishing Hope Therapeutics, a network of interventional psychiatric clinics expected to generate revenue in 2025 [1][9][27] Core Points and Arguments - **Mental Health Crisis**: - Suicide is the second leading cause of death among young people, with a suicide occurring every 11 minutes in the U.S. [10] - Veterans and active-duty personnel face a significantly higher risk, with 22 suicides daily [10] - **Innovative Drug Development**: - NRx is integrating drug development with clinical care delivery to enhance treatment efficacy [11] - Current treatments have a 60-70% response rate, while integrated approaches could improve this to 90% [12] - **NRX-100**: - Aims to replace the $750 million generic ketamine market and compete with J&J's Spravato, which generated $1.4 billion last year [19] - Unique selling point: preservative-free formulation, avoiding toxic preservatives like benzalkonium chloride [18][19] - **NRX-101**: - Targets bipolar depression, where individuals are 10 times more likely to commit suicide compared to those with major depressive disorder [25] - Addresses a market of approximately 600,000 individuals with suicidality and akathisia [26] Market Potential - **Bipolar Depression**: - Significant unmet need with 3 million individuals affected, and current alternatives are limited [25] - **Hope Therapeutics**: - Targeting a $100 million revenue run rate and profitability by the end of 2025, driven by high patient demand for effective treatment options [27] Additional Insights - **Neuroplasticity**: - The company emphasizes the role of neuroplasticity in treatment, with drugs like d-cycloserine enhancing the effectiveness of therapies like transcranial magnetic stimulation (TMS) [26] - **Long-term Vision**: - Plans to build an integrated network of care similar to Cancer Centers of America, making advanced psychiatric care accessible in local communities [28][29] Conclusion - NRx Pharmaceuticals is positioned to address critical mental health challenges through innovative drug development and integrated care solutions, with significant market opportunities in treating suicidal depression and bipolar disorder. The establishment of Hope Therapeutics is a strategic move to enhance patient access to effective treatments and achieve financial milestones by 2025 [1][27][28].

Core Insights - HOPE Therapeutics, Inc. has completed the acquisition of Dura Medical, which will enhance its service offerings across more than 8 locations in West Florida [1][9] - Dura Medical specializes in treating depression, PTSD, and chronic pain using advanced interventional psychiatry techniques [2][9] - The acquisition aims to expand HOPE's network and improve access to mental health services, particularly for veterans [3][5][9] Company Overview - Dura Medical was founded in 2018 and operates in Naples and Ft. Myers, Florida, focusing on a precision approach to mental health treatment [2][9] - The company utilizes innovative therapies such as Ketamine Infusion Therapy and Transcranial Magnetic Stimulation (TMS) to provide comprehensive care [2][9] - Dura Medical is revenue-generating and EBITDA positive, indicating a strong financial position [1] Strategic Goals - The combined entity aims to treat over 10,000 individuals by 2026, reflecting a commitment to reducing suicide rates in the community [5] - HOPE Therapeutics plans to leverage Dura's expertise and expand its network throughout Florida [6][9] - The appointment of Stephen Durand as Director of Florida Clinic Operations is expected to enhance operational leadership and patient care [4][6] Industry Context - The mental health crisis in the U.S. is significant, with over 13 million Americans contemplating suicide annually [2] - Dura Medical's participation in the Veterans Affairs Community Cares Network is crucial for providing mental health support to veterans, who face high rates of suicide [3][9] - The integration of psychedelic medications with traditional therapies represents a growing trend in the treatment of severe mental health disorders [6]

Company Overview - NRx Pharmaceuticals, Inc. 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 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression and NRX-101 receiving Breakthrough Therapy Designation for suicidal bipolar depression [4] - NRx Pharmaceuticals has 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 for suicidal depression treatment [4] HOPE Therapeutics - HOPE Therapeutics, Inc. is a subsidiary of NRx Pharmaceuticals, aiming to establish a network of interventional psychiatry clinics offering ketamine, transcranial magnetic stimulation (TMS), and other therapies for patients with suicidal depression [5] - The company plans to integrate a digital therapeutic-enabled platform to enhance the clinical benefits of NMDA-targeted drug therapy [5] Upcoming Events - Jonathan Javitt, M.D., M.P.H., Chairman and CEO of NRx Pharmaceuticals, will participate in a fireside chat at H.C. Wainwright's 27th Annual Global Investment Conference on September 8, 2025, from 4:30 to 5:00 PM ET [1] - A webcast of the fireside chat will be available on the company's website, with a replay accessible for 30 days post-event [2] - Management will also engage in one-on-one investor meetings during the conference, with interested investors encouraged to contact their H.C. Wainwright representative or Brian Korb at astr Partners [3]

Core Insights - NRx Pharmaceuticals, Inc. is preparing to launch HOPE Therapeutics clinics in Fall 2025, focusing on treating suicidal depression, PTSD, traumatic brain injury, and cognitive dysfunction through a unique residential program that combines various therapies [1][6] - The company recently raised over $8.8 million from biotechnology investors to support its initiatives, with no variable rate features involved in the offering [3][6] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal depression and PTSD, utilizing its NMDA platform [5] - The company is advancing neuroplastic drug development, including 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 specific depression treatments [5][7] HOPE Therapeutics Initiative - HOPE Therapeutics will be the first program in the nation to integrate neuroplastic drugs with established treatments like transcranial magnetic stimulation and hyperbaric oxygen therapy, aiming for a response rate exceeding 90% [3][6] - The program will also include nutritional therapy and outdoor activities, creating a comprehensive treatment environment [1][3] Advisory Board and Leadership - Matthew Rockefeller has joined the advisory board of HOPE Therapeutics, enhancing the initiative's leadership and strategic direction [1][6] - The initiative is supported by prominent figures from leading family offices, emphasizing collaboration and innovation in addressing mental health challenges [2]