NRX Pharmaceuticals, Inc. Q4 FY2023 earnings call

• 2023 was pivotal for NRx, with advancements in interventional psychiatry. NRX-101 is a key drug with potential for treating severe depression, suicidality, and chronic pain. • Secured global commercial partnership for NRX-101, received $5M advance with potential $330M in milestones. • Expanded patent portfolio for NRX-101 in chronic pain, opened FDA IND for chronic pain. • Obtained efficacy data for ketamine in suicidal depression and positioned for FDA approval in 2024. • NRX-101 showed efficacy in complicated UTI and Pyelonephritis,获qualified infectious disease product and Fast Track designation. • Stephen Willard discussed reducing cash burn, debt reduction from $11M to ~$5.4M, maintaining NASDAQ listing via reverse split, adding Janet Rehnquist to board. • Intend to distribute Hope Therapeutics shares to shareholders and list Hope on national exchange, aiming to launch product in early 2025.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Expect revenue flow from commercial operations by end of 2024. • Plan to distribute Hope Therapeutics shares to existing shareholders and list Hope on a national exchange. • Aim to launch Hope's product at the beginning of 2025.

• Forward-looking statements subject to risks and uncertainties where actual results may differ from expectations. • Challenges in drug approval processes and market competition for NRX-101 and other products.

Q: Elaborate on Hope in digital therapeutics and development route over next year or two?

A: Digital therapeutics began in military, involves synchronizing breathing/heart rate like a video game. NRx is civilianizing this for ketamine clinic patients, and these techs could extend IP horizon.

Q: Database lock this week, top line data end of month. Walk through next 2 steps and road map over next 12 months?

A: Database lock means data file is handed to statisticians for analysis. If data positive, plan to meet with FDA and Alvogen to align on registration study for NRX-101 to bring it to market for severe depression and suicidal ideation. If data positive, will meet with FDA to align on registration study.

Q: Pricing and reimbursement strategy for ketamine?

A: FDA approval is key for insurance reimbursement. Currently, only cash-paying patients have access. Payers are willing to pay for the therapy as alternative treatments like psychiatric hospitalization and electroshock are costly and ineffective.

Q: Congratulations on progress. Talk about pricing and reimbursement for ketamine?

A: J&J has an approved ketamine drug with over $600M in sales, but it's not indicated for bipolar depression and has REMS issues. There's a market opportunity as insurance coverage is key, and payers are willing to pay due to high costs of alternatives.