NRX Pharmaceuticals, Inc. Q3 FY2024 earnings call

• NRx is advancing NRX-100 (IV ketamine) and NRX-101 (oral treatment for suicidal bipolar depression) toward NDA filings in 2024. - Hope Therapeutics aims to generate revenues by year-end through acquiring revenue-generating precision psychiatry groups, with nonbinding letters of intent signed and acquisition financing in progress. - Jonathan Javitt announced Michael Abrams as the new Chief Financial Officer. - For NRX-100: FDA Fast Track designation expansion sought, 12-month stability data completed, pediatric study plan aligned with FDA. - For NRX-101: Demonstrated reduction in suicidality and akathisia, with plans to file for accelerated approval. - Hope Therapeutics to offer precision psychiatry treatments with ~30% profit margins, aiming for independent funding and potential public listing, and a portion of earnings to support NRx's profitability.

For the three months ended September 30, 2024, NRx Pharmaceuticals reduced its operating net loss by nearly 75% year-over-year from $6.1 million in Q3 2023 to $1.6 million in 2024. Research and development expenses decreased from $3.3 million in 2023 to $0.6 million in 2024, primarily due to the conclusion of the Phase IIb/III study for NRX-101 and cash conservation efforts. General and administrative expenses slightly decreased from $2.5 million in 2023 to $2.4 million in 2024. For the nine months ended September 30, 2024, net loss was $16.1 million compared to $25.8 million in the prior year. Research and development expenses decreased 52% to $5.2 million, and general and administrative expenses decreased 11% to $10.9 million. As of September 30, 2024, cash and cash equivalents were $1.6 million, with additional cash from secured debt financing of $5.4 million subsequent to that date.

• Forecasted profitability in 2025 with revenue from Hope Therapeutics and drug sales. - PDUFA dates expected for NDAs of NRX-100 and NRX-101 in 2025. - Hope Therapeutics aims for $25 million in revenue by year-end and over $100 million by the end of next year.

• Execution risk in acquiring and integrating Hope Therapeutics clinics. - Uncertainty in FDA approval timelines for NDAs. - Market acceptance of the precision psychiatry model and ability to scale Hope's national network.

Q: Jason Kolbert asked about the accelerated approval process for NRX-101 and PDUFA timelines for NDAs.

A: Jonathan Javitt explained accelerated approval is based on intermediate endpoints, with NRX-101 intending to use akathisia and suicidality as intermediate endpoints, and PDUFA dates expected in 2025 for both NDAs.

Q: Jason Kolbert asked about Hope's clinic acquisition and valuations.

A: Jonathan Javitt and Michael Abrams responded that there are not enough clinics meeting the model, with options to acquire or build, and valuations vary, but capital is available for both approaches.

Q: Ed Woo asked about clinic valuations and building vs buying.

A: Jonathan Javitt stated there aren't enough clinics meeting the model, with choices between acquiring and enhancing or building from scratch, and NRx will be opportunistic.

Q: Vernon Bernardino asked about revenue recognition and guidance.

A: Michael Abrams responded that revenue recognition will be compliant with GAAP, and when disclosed publicly, details will be complete, but specifics aren't ready yet.