- On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024 with 2025 PDUFA date forecast.
- HOPE Therapeutics acquiring Interventional Psychiatry Clinics; key to developing a best-in-class network of care to prevent suicide, continues to expect first revenue by year-end 2024.
- 74% reduction in net operating losses compared to 3rd quarter 2023 with profitability forecast in 2025 from HOPE Therapeutics and from sales of medication.
- Management to host a conference call November 18, 2024 at 4:30 PM ET
WILMINGTON, Del., Nov. 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 September 30, 2024 and provided a business update.
Key Clinical and Business Activities
- NRX-100 (IV Ketamine) safety and efficacy data have been aggregated from clinical trials in more than 500 patients in collaboration with leading US and French Universities that demonstrate a highly significant reduction in suicidal ideation compared to placebo and active comparator. IV ketamine has been shown to be superior (in post-hoc analysis) to electroshock therapy in treating depression. Stability data has now been generated for three manufacturing lots required for NDA filing in suicidal depression, toxicology data are complete, and alignment with the FDA on its Pediatric Study Plan has been received. If approved, NRX-100 would be the world's first medicine to treat acute suicidality, a condition that kills 1 American every 11 minutes, according to the US Centers for Disease Control.
- NRX-101 NDA for accelerated approval in bipolar depression with suicidality or akathisia advancing, based on data from the Phase 2b/3 trial in suicidal patients with bipolar depression, which 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). These data, along with data from our STABIL-B trial, support a possible best-in-class suicidal bipolar depression medication profile. This is a multi-billion-dollar market in the US.
- HOPE Therapeutics, the Company's wholly owned subsidiary, announced signing of two Letters of Intent (LOI) to acquire foundational Interventional Psychiatric Clinics, a key to developing a best-in-class network of clinics that offer a complete range of lifesaving therapies to patients with suicidal depression and PTSD. These are revenue generating, EBITDA positive acquisitions.
- Secured $10.8 million in convertible-debt funding from an institutional investor; funds targeted to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101 and retirement of prior debt. Funding at a reduced in interest rate, conversion discount, and other financial terms compared to prior debt.
- Retired Streeterville debt and settlement of litigation at a substantial discount.
Key Upcoming 2024 Milestones
- NRX-100 New Drug Application (NDA) filing for treatment of suicidal ideation in depression, including bipolar depression, based on data from four clinical trials in more than 500 participants demonstrating highly significant efficacy compared to placebo and active comparator, together with a 420-person non-inferiority trial compared to electroshock therapy planned to be filed in 2024.
- Company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101 (D-cycloserine+lurasidone) in treatment of bipolar depression in people akathisia or suicidality, based on the Phase 2b/3 and STABIL-B data in 2024. Akathisia is considered a lethal condition and there is no approved product for this indication.
- HOPE Therapeutics continuing to build its nationwide network of Interventional Psychiatry Clinics; the company is planned to be spun out as a separate entity to be owned by NRx, current NRx shareholders, and new investors.
- NRx continues to forecast first corporate revenues by year-end 2024 with profitability forecast in 2025.
"Our work in recent months has set the stage for major advances in our business. Moving forward on new drug applications for NRX-100 and NRX-101, along with building HOPE's best-in-class network of Interventional Psychiatry Clinics, significantly advances our mission of preventing and treating suicide. This is vital for patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, CEO and Chief Scientist of NRx Pharmaceuticals. "I would like to commend our team on its hard work and dedication, and thank our shareholders for their ongoing support of our mission to bring hope to life."
Third Quarter Clinical, Regulatory and Corporate Highlights
Progress towards an NDA for NRX-100 (IV ketamine) in the treatment of Suicidal Depression
Intravenous ketamine has now become a de-facto standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product and has been identified as such by the US Department of Defense and the Veterans Health Administration. Intranasal Esketamine is approved by the FDA (SPRAVATO®) but its label specifies that it 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 together with multiple NIH-funded trials all of which demonstrate efficacy of racemic Intravenous ketamine against suicidal ideation in depression, including bipolar depression. 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.1 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