NRX Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Drug development progress: Initiated filing of NDA for NRX-100 (preservative-free intravenous ketamine for suicidal depression) with FDA, supported by efficacy data and stability data; preparing NDA for NRX-101 (fixed-dose oral combination for suicidal depression) with anticipation of initiating filing in current quarter. - HOPE Therapeutics: Founded a subsidiary to develop a national network of clinics for delivering integrated neuroplastic therapies; signed purchase agreements and letters of intent to acquire clinics; reduced core corporate expenses. - Patent filing: Filed a patent for novel preservative-free formulation of NRX-100 with USPTO, potentially protecting the product until 2045. - Cost reduction: Substantially reduced core corporate expenses and has more cash on the balance sheet.

For the three months ended March 31, 2025, NRx Pharmaceuticals reported a net loss of $5.5 million compared to a net loss of $6.5 million in the comparable quarter of 2024. The loss from operations was $3.8 million versus $6 million in the comparable quarter of 2024. Research and development expenses were $0.8 million and general and administrative expenses were $2.9 million compared to $1.7 million and $4.3 million respectively for the comparable quarter ended March 31, 2024. The company has two operating groups: NRx Pharmaceutical, a biotech drug development company, and HOPE Therapeutics, a patient care subsidiary working on establishing a national network of clinics. NRx Pharmaceutical is advancing drug candidates NRX-100 and NRX-101 in the regulatory process, while HOPE Therapeutics is focused on building a network of clinics for treating suicidality, depression, PTSD, etc.

• Anticipates being a revenue-generating company by early next year with proprietary ketamine drug NRX-100. - Plans to have NRX-100 on the market by early next year if FDA approval is obtained. - Forecasts profitability on a going-forward run rate basis by the end of 2025 with revenue and EBITDA from HOPE Therapeutics and potential sales of medications. - Anticipates 2025 PDUFA dates for NDAs of NRX-100 and NRX-101.

• Long-term safety issues with current ketamine formulations: Preservatives like benzethonium chloride are neurotoxic and toxic to epithelial cells; repeated use associated with urinary tract and bladder damage. - pH issues with current ketamine formulation: pH less than four precludes subcutaneous administration and causes challenges with oral administration.

Q: What does the recent IP buy if approved and thoughts on the strength of the patent application to leave the preservative out and its importance?

A: Jonathan Javitt stated that the patent counsel is experienced and believes in the claims. It matters as drugs with toxic preservatives are likely to be withdrawn. May have longer exclusivity on racemic ketamine and preservative-free preparation than originally anticipated. The pH-neutral form is proprietary and patentable but may have longer protection from the preservative-free version due to focus on removing toxic preservatives from food and drug supply.

Q: Have you given consideration for NRX-100 and HOPE Therapeutics to go internationally beyond the U.S.?

A: Jonathan Javitt mentioned that they intend to make NRX-100 available more broadly and European countries are more sensitive to toxic substances in foods and drugs, so there is significant international potential for NRX-100 and they've been approached by international entities for that purpose