NRX Pharmaceuticals, Inc. Q2 FY2024 earnings call

• Scientific front: Poised to file two NDAs in coming months for NRX-100 (intravenous ketamine for clinic-based suicidal depression) and NRX-101 (oral combination for home-based bipolar depression with suicidality/akathisia). A retrospective study on ketamine showed reduced suicidal ideation. NRX-101 data shows it's the first oral antidepressant to reduce akathisia and suicidality.
• Business front: Laid foundation for roll-up of ketamine and interventional psychiatry clinics, reduced operating costs, cut loss per share by nearly 50% year-over-year.
• Financing: Secured $16 million funding from Anson Partners, stabilized balance sheet, eliminated toxic debt, and will use funds for FDA submissions and retiring debt with better terms.

For the three months ended June 30, 2024, NRx Pharmaceuticals reduced net loss from $8.7 million in Q2 2023 to $7.9 million in 2024, a nearly 10% improvement. Research and development expenses decreased from $3.9 million in 2023 to $2.8 million in 2024. For the six months ended June 30, 2024, net loss was $14.4 million compared to $19.8 million in the prior year, an improvement of $5.4 million. R&D expenses decreased from $7.5 million in 2023 to $4.6 million in 2024, a 39% decrease. General and administrative expenses also decreased year-over-year.

• Aim to file NDAs for NRX-100 and NRX-101 in coming months.
• Hoping for drug approvals in 2025 and making drugs available to patients.
• Plan to launch HOPE Therapeutics clinic acquisition program financed non-dilutively.
• Starting search for a CEO with commercial experience in pharmaceutical marketing.

• Forward-looking statements subject to risks and uncertainties causing actual results to differ.
• Challenges in FDA approval process, including requirements for fully manufactured stable drugs and pediatric study plans.
• Competition and regulatory changes impacting drug approval and commercialization.

Q: Have you given thought about international opportunities for both NRX-100 and 101?

A: Rest of the world is important, have foreign patent approvals, added a leading French psychiatrist to advisory board, but initial launch will be in the U.S.

Q: Tell us more about the HOPE business plan, how the funding is going to work and what the benefits to NRx shareholders may be?

A: HOPE Therapeutics will bring together best-of-breed ketamine and interventional psychiatry clinics, with funding non-dilutive to NRx, expected to build value for shareholders.

Q: As you guys are planning on submitting NDAs this year and possible approval for next year, have you thought about your commercial strategies, whether you will develop your own commercial team or whether you’ll look for commercial partners?

A: For NRX-100, clinics using the drug are limited and some will be HOPE-owned, so no need for large commercial partner. For NRX-101, can reach key prescribers with a compact sales force; Matt Duffy discussed targeted sales force approach.