NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Second Quarter 2025 Financial Results and Provides Corporate Update
NRx Drug Development
Grant of expanded Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need.
Represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone.
The Designation letter contains a specific finding that NRX-100 addresses an "unmet medical need." This is a specific qualifying requirement for the Commissioner's National Priority Voucher Program.
Filing of Commissioner's National Priority Voucher application for intravenous ketamine (NRX-100).
Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received.
Filing of an Abbreviated New Drug Application (ANDA) for NRX-100 (preservative-free intravenous ketamine).
Submission of stability data for NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100.
Completion of a toxicology assessment of Benzethonium Chloride1, documenting its lack of "Generally Recognized as Safe" (GRAS) status and lack of safety data to support its use in intravenous presentations of ketamine.
Filing of a Citizen's Petition with the U.S. Food and Drug Administration to seek the removal of benzethonium chloride, a toxic preservative, from all ketamine products for intravenous administration.
Filing of a patent application for NRX-100, the Company's proprietary preservative-free formulation of intravenous ketamine.
Receipt of a PDUFA filing fee waiver from the FDA for NRX-100.
Filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication.
HOPE Therapeutics
Execution of definitive Purchase Agreement and receipt of final regulatory clearance from Florida's Agency for Health Care Administration ("ACHA") to proceed with closing the acquisition of Dura Medical.
Execution of binding letter of intent to acquire the assets of NeuroSpa TMS Holdings of Tampa, FL.
Execution of a binding letter of intent to acquire a 49% interest in Cohen and Associates, LLC.
Receipt of approval, pending legal stipulations, for $7.8 million of debt financing to support the acquisition of Dura Medical, NeuroSpa TMS Holdings, and Cohen and Associates, LLC.
Execution of a definitive purchase agreement, subject to standard closing conditions and agreement between the parties regarding the resolution of ongoing discussions, to purchase the non-clinical assets of Kadima Neuropsychiatry Institute.
Execution of a non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE.
Corporate (subsequent to the filing of form 10-Q)
$6.5 million dollar investment to purchase approximately 3.9 million shares of common stock of NRx Pharmaceuticals on August 18, 2025, by a consortium of experienced biotechnology investors led by B Group Capital. The purchase is subject to a one-year lockup on trading, shorting, or otherwise hypothecating said securities. The investment has no warrants, repricing provisions, commissions, or other structure.
The B Group Capital led consortium of ultra long-term healthcare specialist investors is highly strategic with extensive experience in complex clinical, regulatory, and commercial therapeutics but also direct ownership and management of multi-unit retail operations with potentially positive long-term implications for efforts to continue to scale and develop HOPE Therapeutics.
A live webcast of the conference call will be available on the Company's website at 8:00 a.m. ET Wednesday August 20, 2025.
WILMINGTON, Del., Aug. 18, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended June 30, 2025, and provided a corporate update.
"NRx has made remarkable progress with all three of our lead programs in recent months. Additionally, as announced today, we have now attracted our first group of fundamental biotechnology investors who have joined us to partner in building a successful commercial enterprise and contributed sufficient capital to reach expected regulatory inflection points. The investor group has aligned its interests in the future growth of our enterprise by purchasing restricted common stock that is subject to a one-year lockup agreement and is devoid of warrants, repricing mechanisms, or other mechanisms that are likely to cause future dilution. Furthermore, the B Group Capital led consortium of investors is strategic as it relates to our efforts to scale-up and develop our HOPE Therapeutics business with the potential to bring future partnerships and operational infrastructure to more quickly realize the potential of our HOPE clinic strategy.
"Last week, we received a markedly expanded Fast Track designation from FDA that establishes the unmet medical need associated with using NRX-100 (preservative-free intravenous ketamine) to treat suicidal depression in more than 13 million Americans each year. Over the past quarter and in subsequent events, we filed an application under the Commissioner's National Priority Voucher Program (CNPV), filed a patent with the USPTO, filed an ANDA for existing indications, and a Citizen's Petition to remove Benzethonium Chloride from IV ketamine products. The Fast Track determination just received qualifies NRX-100 for the stated requirements of the CNPV. We have continued to advance NRX-101 (oral D-cycloserine/lurasidone), initiated filing of an NDA for Accelerated Approval in bipolar depression and akathisia, and advanced our development of the HOPE clinic network," said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "This continuing flow of accomplishments reflects our commitment to Bringing Hope to Life by delivering life-saving treatments to soldiers, first responders, veterans, and civilians in urgent need."
Key Research and Development and Corporate Activities
NRX-100We have undertaken two paths to market for NRX-100: a generic-approval path under an Abbreviated New Drug Application (ANDA) to address the current generic market for ketamine, and an innovative drug path under ...
