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- **Revenue Breakthrough**: First-quarter $240K revenue from 22 days of clinic operations, up from $0 prior. 
- **Pipeline Milestones**: 
  - NRX-100 NDA submission complete; ONE-D protocol achieves 87% depression remission rate. 
  - NRX-101 Phase 3 trial planned for Q1 2026, with 1M doses manufactured. 
- **Strategic Scale**: 
  - $10.3M cash on hand; >$20M annualized revenue potential from clinic acquisitions. 
  - 50-person salesforce planned for NRX-101 launch in 2026. 
- **Market Impact**: 
  - 13M Americans with suicidal ideation annually; NRX-100 targets $750M ketamine market. 
  - ONE-D protocol deploys in Florida with portable TMS devices. 


**【Management Opening Remarks】**
- **Revenue Generation**: First-time quarterly revenue of $240,000 from 22 days of operations at HOPE Therapeutics' Florida clinics, driven by ketamine and TMS treatments. 
- **Pipeline Momentum**: 
  - NRX-100 (preservative-free IV ketamine) NDA submission nearing completion for suicidal depression. 
  - NRX-101 (DCS + lurasidone) Phase 3 trial planned for Q1 2026, with 1 million doses manufactured. 
  - ONE-D protocol combining TMS and DCS achieved 87% response rate in real-world data. 
- **Strategic Positioning**: $10.3M cash balance as of Q3, with $7.1M in cash equivalents. Expanded access programs for NRX-101 and ONE-D protocol launched. 

**【CFO Financial Commentary】**
- **Financial Performance**: 
  - Loss from operations: $4M (vs. $3M YoY), driven by R&D ($800K) and G&A expenses ($400K). 
  - Revenue growth potential: >$20M annualized from pipeline clinic acquisitions. 
- **Liquidity**: $10.3M cash post-October subscription receipts, supporting operations through Q2 2026. 
- **Key Metrics**: 
  - 60,000+ patient encounters for NRX-100, 1,000+ trial participants for NRX-101. 
  - 72% remission rate in ONE-D protocol for severe depression. 

**【Q&A Highlights】**
- **Regulatory & Commercial Strategy**: 
  - NRX-100: Seeking accelerated approval for suicidal depression, with FDA CNPV review expected. 
  - NRX-101: 50-person salesforce planned for bipolar depression indication. 
  - ONE-D protocol: First U.S. deployment in Florida, with portable TMS devices enabling broader reach. 
- **Manufacturing & Supply Chain**: 
  - Blow-Fill-Seal packaging for NRX-100 enables 1M+ monthly production capacity. 
  - Expanded access program for NRX-101 provides free doses to 25,000+ patients. 
- **Market Impact**: 
  - 13M Americans with suicidal ideation annually; CDC estimates 1 suicide every 11 minutes. 
  - Ketamine market projected at $750M, with NRX-100 targeting toxic-free alternative. 


NRx Pharmaceuticals, Inc. (NRXP) Q3 2025 Earnings Call Transcript

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