- 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 study1
- 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 depression in people akathisia or suicidality, based on the Phase 2b/3 and STABIL-B data
- Stability 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 NDA
- HOPE 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 Directors
- Management to host a conference call August 14, 2024, at 4:30 PM ET
RADNOR, Pa., Aug. 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year to date ended June 30, 2024, and provided a business update.
"NRx has continued to execute on our plans to file two NDA's this year. As we near maturation of NRX-100 stability data, we also achieved an important milestone in aligning with FDA on our pediatric study plan. Together with strong clinical data from four clinical trials, we believe this application will be quite robust. Additionally, the important data generated from two trials conducted by NRx with NRX-101 in suicidal bipolar depression sets the stage for a second NDA for Accelerated Approval later this year. Finally, work continues to spin out Hope Therapeutics and distribute shares to NRx stockholders. We believe reaching these important milestones will generate significant value in the company and reward our shareholders," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. "Facilitated by funding to allow us to achieve these goals and while replacing the prior expensive and toxic debt on our balance sheet, we are in a position to deliver therapy that can meet considerable unmet medical need in millions of patients across the country. We are dedicated to bringing hope to life and I thank our team and shareholders for their ongoing hard work and support."
Second Quarter Clinical, Regulatory and Corporate Highlights
Funding for FDA filings of NRX-100 and NRX-101
The Company has executed a Convertible Debt instrument with Anson Funds of Toronto for $10.8 - $16.3 million in funding designed to retire existing debt and to support FDA New Drug filings of NRX-100 and NRX-101 in the fourth quarter of 2024. Terms have been disclosed in 8K filings but are at an interest rate and conversion rate substantially lower than current corporate indebtedness. The new funding has no provision for "extraordinary redemptions" triggered by appreciation in NRx share price.
Retirement of current debt and settlement of litigation
Concurrent with the Anson investment, the Company has settled its outstanding litigation with Streeterville Capital, LLC at a substantial discount to the amounts claimed in litigation.
Progress towards an NDA for NRX-100 (IV ketamine) in the treatment of suicidal depression
Intravenous ketamine has now become a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product. Intranasal Esketamine is approved by the FDA (SPRAVATO®) but has not demonstrated a benefit on suicidality and is not approved for use in patients with bipolar depression. Attempts to use intranasal racemic ketamine for suicidal depression have failed.
The Company has formed data-sharing partnerships to license clinical trial data from a French Government-funded trial and two NIH-funded trials all of which demonstrate efficacy of racemic Intravenous ketamine against depression and two of which demonstrate statistically significant benefit vs suicidality. The Company's role is to reformat these data into the required presentation required for review by the FDA.
In contrast to nasal ketamine, Intravenous racemic ketamine demonstrates dramatic and immediate reduction of suicidality in patients with both Major Depressive Disorder and Bipolar Depression. Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States (POMS) among patients randomized to IV Ketamine compared to those randomized to midazolam. This trial was published in the American Journal of Psychiatry Grunebaum, et.al.2. Abbar and colleagues similarly published 84% remission from suicidality on the Columbia Suicide Severity Rating Scale (C-SSRS) in patients treated with ketamine, vs. 28% in those treated with placebo (P