NRx Pharmaceuticals (NRXP) H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference summary

Scientific and clinical background

• NRX-101 is an oral fixed-dose combination targeting the NMDA receptor, developed for suicidal, treatment-resistant bipolar depression.

• NMDA-blocking drugs, such as ketamine, have shown rapid antidepressant effects and reduction in suicidal ideation.

• NRX-101 demonstrated comparable antidepressant efficacy to standard-of-care drugs but uniquely reduced akathisia, a severe side effect.

• Clinical trials showed significant improvements in both suicidality and akathisia, with a p-value of 0.03 in the latest study.

• No oral antidepressant before has shown improved time to remission from suicidality.

Regulatory and development strategy

• Plans to seek accelerated FDA approval for NRX-101 in patients experiencing akathisia from standard treatments.

• FDA approval for broader use will require exposure data on 1,500 patients and efficacy data on about 500.

• A registrational trial is planned, with initial focus on a narrow patient group, expanding to larger populations post-approval.

• Manufacturing data for both ketamine and NRX-101 are being finalized, with NDA filings expected in the fall.

• NRX-101 is also being evaluated for fast track and QIDP designation for complicated urinary tract infections.

Partnerships and financial outlook

• Collaboration with Alvogen and Lotus Pharma includes a $5.1 million initial investment and an option for further clinical development.

• Payer research suggests pricing under $10,000 per patient per year would avoid major formulary restrictions.

• Capturing a significant market share could yield multi-billion dollar annual revenues, though initial targets are more modest.

• HOPE Therapeutics is being spun out to deliver IV ketamine, aiming for cash flow positivity in 2025.

• The HOPE spin-out audit is complete, with more details expected by the end of the month.