• Developing Therapeutics for the Treatment of CNS Disorders, Specifically Suicidal Bipolar Depression, Chronic Pain and PTSD.
• Company Funded For New Drug Applications (NDAs) for NRX-100 (ketamine) and NRX-101
• Audit of HOPE Therapeutics Subsidiary Complete, SEC Filing of Spinout Planned for Current Quarter.
• Secured $10.8 - $16.3 Million Convertible-Debt Funding from an Institutional Investor.
• Retirement of Older Debt and Settlement of Litigation at Substantial Discount.
• NRX-100 NDA for Suicidal Depression Based on Data from Four Clinical Trials in Nearly 1000 Participants Demonstrating Highly Significant Efficacy.
• Ketamine Findings Confirmed in Published 43,000 Person Cohort Study.
• Phase 2b/3 Trial Data Presented at the American Society of Clinical Psychopharmacology. Profile Demonstrates Possible Best in Class.
• Plans to file New Drug Application for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101.
• Stability Data Continues to Mature on Three Manufacturing Lots Required for the NRX-100 (IV ketamine) NDA filing.
• Company Announced Alignment with FDA on its Pediatric Study Plan for NRX-100, Also a Requirement for Filing of NDA.
• HOPE Therapeutic Subsidiary Focused on Developing a Best-in-Class Network of Clinics for Patients with Suicidal Depression and Related Disorders.
• HOPE is Planned to be Spun Out as a Separate Company to be Owned by NRXP Shareholders, and New Investors. Effort to be Funded Apart from NRXP.
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain
NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
2nd Quarter and Year to Date 2024 Financial Results with Business Update
On August 14th NRXP announced its financial results for the quarter and year to date ended June 30, 2024, and provided a business update.
Second Quarter Clinical, Regulatory and Corporate Highlights
NRXP 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 NRRP share price.
Concurrent with the Anson investment, NRXP 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.
NRXP has formed 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 NRXP role is to reformat these data into the required presentation required for review by the FDA.
A long-term challenge with ketamine is that the current formulation (KETALAR®) is highly acidic. While it is suitable for intravenous use, it cannot be administered subcutaneously. In March 2024 NRXP demonstrated the formulation of a pH neutral patentable form of IV ketamine that it anticipates will have widespread applicability both in treatment of depression and chronic pain.
Development of NRX-101 for Suicidal Treatment-Resistant Suicidal Bipolar Depression
NRXP presented final data from the recently completed phase 2b/3 trial of NRX-101 in suicidal bipolar depression4 at the American Society of Clinical Psychopharmacology's annual meeting. These data demonstrated a significantly improved safety profile versus the standard of care, as demonstrated by a clinically significant reduction in akathisia (P=0.025) and time to sustained remission from suicidality (P=0.05). Akathisia is an adverse event seen with antidepressant medications considered by many experts to be a precursor to suicide. Given the vital need for safer medications in this at-risk population, we plan to submit an NDA for Accelerated Approval to the US FDA for treatment of bipolar depression patients with suicidality or akathisia, based on these data as well as additional data from our STABIL-B5 trial.
HOPE Therapeutics, is an NXRP subsidiary that will focus on the delivery of advance psychiatric treatments, including ketamine-focused treatment for depression and suicidality. Unlike the core business of NRXP, that is focused on biotechnology Research and Development, HOPE is organized around consolidating existing best-in-class clinics into a nationwide network. This has been done previously and without much success with clinics that are not necessarily psychiatrist-led. With Hope ownership as an asset of NRXP, this will further strengthen the NRXP balance sheet and aims to further enhance shareholder value.
NRX-101 for Treatment of Chronic Pain:
In 2023, NRXP licensed US Patent 8,653,120 for the use of DCS in chronic pain and filed a now-accepted Investigational New Drug (IND) application with the FDA to initiate commercial drug development of NRX-101 in chronic pain. Data lock has now been achieved in a 200-person randomized prospective trial funded by the US DOD.
During Q3 2023, NRXP tested NRX-101 and its components against resistant pathogens that appear on the Congressionally mandated Qualified Infectious Disease Product (QIDP) list and proved in vitro effectiveness against antibiotic-resistant E. coli, Pseudomonas, and Acinetobacter. Accordingly, NRXP was granted QIDP designation, Fast Track Designation, and Priority Review by the US FDA in January 2024.
Should NRX-101 succeed in clinical trials, NRXP will consider developing a follow-on product that is anticipated to achieve another 20 years of patent exclusivity.
NRXP recently announced data demonstrating that NRX-101 does not compromise the intestinal microbiome, unlike common antibiotics including Clindamycin and Ciprofloxacin. Should these findings be documented in human patients, NRX-101 would represent the only treatment for cUTI that does not cause C. Difficile infection.
Additionally, should NRXP or its partners succeed in serving 10% of the cUTI market, NRXP believes that the revenue from NRX-101 has the potential to be hundreds of million annually, based on 3 million cases per year in the US and potential pricing of over $3,500/course of therapy.
Financial Results for the Quarter and Year to Date 2024
For the three months ended June 30, 2024, we at NRXP reduced net loss from $8.7 million in the second quarter of 2023 to $7.9 million in 2024, representing nearly a 10% improvement year over year. For that same period, NRXP reduced research and development expenses from $3.9 million in 2023 to $2.8 million in 2024. The $1.1 million decrease is related primarily to a decrease of $2.4 million in clinical trial and development expenses, offset by an increase of $1.3m related to the Alvogen warrants. Also in that 3 month period NRXP recorded an increase in general and administrative expenses, from $4.1 million in 2023 to $4.2 million in 2024. The increase of $0.1 million is related primarily to an increase in consultants and legal fees partially offset by lower insurance expenses.
As of June 30, 2024, NRXP had $1.9 million in cash and cash equivalents. The $16.3 Million Senior Secured Debt Financing from Anson Funds is expected to support a 2024 filing of New Drug Applications for NRX-100 (ketamine) and NRX-101 and to support launch of HOPE Therapeutics as well as retire historical debt with more favorable terms, and a lower annual interest rate.
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Media Contact
Company Name: NRx Pharmaceuticals, Inc.
Contact Person: Jonathan Javitt, Founder of $NRXP
Email: Send Email
Phone: 484 254 6134
Address:1201 Orange Street Suite 600
City: Wilmington
State: Delaware 19801
Country: United States
Website: https://www.nrxpharma.com/
