Company is now funded for and focused on New Drug Applications (NDAs) for NRX-100 (ketamine) and NRX-101 Audit of HOPE Therapeutics is now complete, SEC filing of spinout this quarter Key Milestones Secured $10.8 - $16.3 million in convertible-debt funding from an institutional investor; funds targeted to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101.
Replacement funding entails substantial reduction in interest rate, conversion discount, and other financial terms compared to prior debt Retirement of Streeterville debt and settlement of litigation at a substantial discount to litigation claims NRX-100 NDA for suicidal depression based on data from four clinical trials in nearly 1000 participants demonstrating highly significant efficacy compared to placebo, active comparator, and electroshock therapy Ketamine findings have just been confirmed in published 43,000 person cohort study 1 Phase 2b /3 trial of NRX-101 in suicidal patients with bipolar depression demonstrated depression efficacy comparable to standard of care and significant reduction of akathisia (P=0.025) and time to sustained remission from suicidality (P=.05).
Presented at the annual meeting of the American Society of Clinical Psychopharmacology. Profile demonstrates possible best in class bipolar depression medication Company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101 in treatment of bipolar dep.