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 debtRetirement of Streeterville debt and settlement of litigation at a substantial discount to litigation claimsNRX-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 therapyKetamine findings have just been confirmed in published 43,000 person cohort study1Phase 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 medicationCompany 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 depression in people akathisia or suicidality, based on the Phase 2b/3 and STABIL-B dataStability data continues to mature on the three manufacturing lots required for the NRX-100 (IV ketamine) NDA filing and the Company announced alignment with FDA on its Pediatric Study Plan for NRX-100, also a requirement for filing an NDAHOPE Therapeutics, the Company's wholly owned subsidiary, is focused on developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders. HOPE is planned to be spun out as a separate company to be owned by NRx, current NRx shareholders, and new investors. This effort will be funded apart from NRx.Appointed Dr. Dennis McBride, a Neuroscience, Information Technology and Medical Technology Veteran, to its Board of DirectorsManagement to host a conference call August 14, 2024, at 4:30 PM ETRADNOR, Pa., Aug. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its second quarter and year to date 2024 financial results after the market closes on Wednesday, August 14, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ET the same day.
RADNOR, Pa., Aug. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has obtained up to approximately $16 million in convertible debt financing (the "Financing") from an institutional investor. The Company intends to use the net proceeds from the Financing to support the 2024 New Drug Application filing its two lead products, NRX-100 and NRX-101 and to retire existing debt from Streeterville Capital. Concurrent with this financing, Streeterville has agreed to stay its arbitration and to release all claims upon receipt of the agreed settlement funds. The interest rate and other costs of capital are substantially lower than prior debt.
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