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NRx Pharmaceuticals (NRXP) investor relations material

NRx Pharmaceuticals Noble Capital Markets Emerging Growth Virtual Investor Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Noble Capital Markets Emerging Growth Virtual Investor Conference summary8 Oct, 2025

Recent developments and strategic focus

  • Intends to generate revenue starting this year, with growth expected over the next two years, driven by three lead programs.

  • NRX-100 (IV ketamine) is being advanced for FDA approval for suicidal ideation and depression, with a broad fast-track indication and a potential $2 billion market.

  • NRX-101, a combination therapy, has breakthrough therapy designation and is the first oral drug shown to reduce suicidality in akathisia.

  • Building a network of HOPE Therapeutics clinics to integrate neuroplastic therapies for depression, PTSD, autism, and brain injury.

  • Developing a preservative-free generic ketamine (KETAFREE) for anesthesia and pain control, targeting a $750 million market.

Clinical and scientific advancements

  • Real-world and clinical trial data show IV ketamine significantly reduces suicidality and depression, with new evidence supporting its use in PTSD.

  • D-cycloserine, especially at low doses, enhances the effect of transcranial magnetic stimulation (TMS) for depression and suicidality.

  • Hyperbaric oxygen therapy and digital therapeutics are being integrated as additional neuroplastic interventions.

  • Combining neuroplastic drugs, TMS, and other therapies is believed to offer a durable path to recovery for suicidal depression and PTSD.

  • Treatments are cost-effective, with full courses delivered for less than $10,000, significantly lower than other major interventions.

Regulatory and market landscape

  • FDA granted a fast-track designation and a filing fee waiver for NRX-100; a Commissioner's National Priority Voucher (CNPV) could accelerate approval.

  • KETAFREE is back on file with the FDA after reformulation to match generic standards.

  • No FDA-approved drugs currently exist for suicidal ideation; current treatments like ECT have significant drawbacks.

  • The administration and federal agencies have made veteran suicide and mental health a top priority, with strong support for innovative treatments.

  • If granted, a CNPV would significantly speed up the regulatory timeline for NRX-100; otherwise, a six-month NDA review is expected.

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Q3 202517 Nov, 2025
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Frequently asked questions

NRx Pharmaceuticals Inc. (NRXP) is a clinical-stage pharmaceutical company focused on developing novel therapeutics for the treatment of central nervous system disorders. The company's portfolio includes ZYESAMI, an investigational drug for COVID-19 related respiratory failure, and oral therapeutics NRX-100 and NRX-101 for the treatment of bipolar depression in patients with acute suicidal behavior/ideation and sub-acute suicidal ideation and behavior. The company is headquartered in Wilmington, Delaware, and its shares are listed on the Nasdaq.

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