NRx Pharmaceuticals, Inc. Q3 FY2025 earnings call

Management Statement and Operational Highlights

• Business Development: Advanced drug approvals for KETAFREE, NRx-100, NRx-101; expanded NRX-101 pipeline via acquisition of HOPE Therapeutics clinics.
• Financials: Q3 revenue from first 2 HOPE clinics ($240k), anticipates revenue growth as clinics expand to 6+ by year-end. Future growth focused on multi-modality treatments with higher payer reimbursement.
• Drug Development: NRx-100 NDA near completion with added real-world data; NRx-101 expanded access program launched; HOPE's ONE-D protocol in Florida shows promising results.

Segment Performance

• KETAFREE: NDA preparation for NRX-100 (suicidal ideation in depression) nearly complete, ANDA for generic ketamine indications in progress. Added over 60,000 patient encounters of real-world efficacy data showing IV ketamine优于 nasal S-ketamine. Filed citizen petition to remove toxic preservative benzethonium chloride from ketamine products.
• NRx-100: NDA for suicidal ideation in depression (including bipolar depression) nearly complete, Fast Track designation expanded to include all patients with suicidal ideation and depression. Real-world data and trial data provide compelling efficacy case.
• NRx-101: Received breakthrough therapy designation, manufacturing data on file with stability trending to 5 years, 1 million doses in warehouse. Expanded access program launched, Phase 3 trial planned for early 2026. Real-world data shows low-dose DCS + TMS has 87% treatment response and 72% remission for severe depression.
• HOPE Therapeutics: Generated first revenue from 2 clinics, anticipates growing to 6+ clinics by year-end. Launched ONE-D protocol in Florida in partnership with Ampa Health, focusing on multi-modality treatments with higher reimbursement.

Guidance

• Anticipate growing HOPE Therapeutics clinics from 2 to 6+ by year-end, with revenue showing strong growth.
• NRx-100 NDA submission expected in coming weeks; NRx-101 Phase 3 trial planned for early 2026.
• Future growth likely focused on multi-modality treatments with higher reimbursement rates.

Risks

• Regulatory: Uncertainties in FDA approval processes, including CNPV determination for NRx-100 and outcome of citizen petition to remove benzethonium chloride from ketamine products.
• Market: Competition in ketamine and TMS markets; challenges in securing payer reimbursement for new multi-modality treatments.

Question and Answer

Q: Historically, is it clear that DCS is much better than Ketamine in this position? Is this truly unique to the drug? Or is it a general combination effect. And then can you give us a sense of how you would use 101 in this procedure?

A: DCS has to be used at a non NMDA antagonist dose. DCS is a mixed agonist antagonist, a highly neuroplastic drug. NRX-101 includes DCS, and there's an expanded access protocol for DCS under laws for use with TMS.

Q: NRX-100 and suicidal depression, the FDA has identified no significant deficiencies to date. I'm wondering, first, what feedback have you received on the accelerated approval strategy. Secondly, do you still anticipate a year-end PDUFA decision?

A: We're in the CNPV process, expecting to hear about CNPV this year. Have real-world data to augment filing for accelerated approval.

Q: With the Citizen Petition now filed to remove benzethonium chloride, can you discuss how this regulatory action could reshape the market for IV ketamine and how you would ensure adequate domestic supply if the FDA moves to ban this preservative-containing formulations?

A: KETAFREE is in Blow-Fill-Seal presentation, allowing higher production capacity. Could supply sufficient ketamine if needed.

Q: As NRX-100 and 101 have potential approval dates relative within the next year, hopefully, or much sooner than that? Have we talked about your clinical or commercialization strategy for both?

A: NRx-100 would need medical science liaison support; NRx-101 may need a sales force or potential partnership, with different strategies for each drug.