European Patent for ALS Program Expands the Story: HOPE Deploys Robotic TMS & FDA Commercialization Path Advances: NRx Pharmaceuticals: NAS DAQ: NRXP

MIAMI - Amzeal -- NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) $NRXP is entering the week with another important development that expands the company's potential opportunity well beyond its original neuropsychiatric focus.

Today, September 14, GeNeuro, Inc., an NRx Pharmaceuticals subsidiary, announced that it has been awarded European Patent EP 3 570 878 B1 for GNK-301, a novel monoclonal antibody candidate targeting Human Endogenous Retrovirus K (HERV K) in Amyotrophic Lateral Sclerosis (ALS). The European patent builds on two previously issued U.S. patents and strengthens the intellectual-property position surrounding GeNeuro's ALS program.

For NRXP investors, today's announcement is important because it adds another potentially valuable clinical-development platform to a company already advancing preservative-free ketamine, NRX-101, advanced TMS and HOPE Therapeutics.

And it comes just days after another major announcement: HOPE Therapeutics is preparing to become the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System, with its Florida clinical team undergoing training ahead of deployment.

Taken together, the latest developments suggest NRx is becoming a considerably broader biotechnology platform.

Today's GeNeuro News Adds a Potential ALS Catalyst

GeNeuro's new European patent covers GNK-301, an antibody developed to target the HERV K envelope protein, or K Env.

According to today's announcement, K Env has been detected in the spinal fluid of more than 75% of people with ALS and has demonstrated neurotoxic effects in laboratory animals and human motor-neuron cell cultures. GNK-301 has been shown in nonclinical work to prevent those effects.

The patent is particularly notable because it adds European protection to two previously issued U.S. patents covering the underlying invention.

GeNeuro has also initiated cGMP manufacturing of GNK-301 and anticipates beginning first-in-human Phase 1 testing in ALS during the second half of 2027, subject to development and regulatory progress.

Why today's announcement matters to NRXP investors:

• European patent protection expands the intellectual-property footprint for GNK-301.
• The ALS program provides NRx with another potential high-value clinical opportunity.
• GeNeuro's portfolio includes additional HERV-targeted programs.
• GNK-301 has connections to research conducted with the U.S. National Institute of Neurological Disorders and Stroke.
• GeNeuro has already been selected in the first round of the Congressionally Directed Medical Research Program for potential awards.

This is potentially important diversification for NRx.

HOPE Therapeutics Is Moving Robotic TMS Toward Real-World Deployment

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Only three days before today's GeNeuro announcement, NRx reported another significant milestone.

On September 11, the company announced that HOPE Therapeutics will be the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System.

Clinical staff are completing orientation and training at Zeta Surgical's Boston headquarters ahead of deployment at HOPE's Florida clinics.

The robotic system builds upon the Zeta TMS Navigation System that HOPE began using earlier this summer.

Its AI-driven software is designed to adjust the TMS coil in real time, tracking patient movement and maintaining submillimeter precision.

This development is especially interesting because the technology directly supports NRx's SPARC-TMS program involving NRX-101 and robotic TMS.

In June, HOPE had already begun treating its first patients using Zeta's FDA-cleared TMS Navigation System in West Palm Beach and Sarasota, marking the transition from technology deployment to active patient care.

NRX-101 and DARPA Could Become Major Catalysts

NRX-101 remains one of NRx's most important pipeline programs.

The company is developing NRX-101, an oral fixed-dose combination of D-cycloserine and lurasidone, for serious neuropsychiatric conditions including suicidal bipolar depression.

NRx has received FDA Breakthrough Therapy Designation for NRX-101 and has advanced a program combining it with robotic-assisted TMS.

The potential scale of that opportunity increased substantially when NRx announced that its defense subsidiary was selected by DARPA as prime contractor for SPARC-TMS, an FDA-approved Phase 2/3 trial.

The anticipated non-dilutive funding is expected to exceed $11.5 million, subject to completion of contracting. The program could potentially expand the NRX-101 opportunity into the much larger treatment-resistant depression population.

The FDA Ketamine Story Remains Front and Center

Despite today's GeNeuro development, the most immediate potential commercial catalyst for NRx remains its preservative-free intravenous ketamine program.

On August 7, NRx announced that the FDA had completed its first-cycle review of the company's ANDA with no drug-related major deficiencies.

The remaining issue concerns certification involving the vial's luer-lock component. NRx has stated that no new clinical, safety or efficacy data are required for approval and that the requested manufacturer attestation has been submitted.

Meanwhile, the company is preparing for commercialization.

NRx has initiated commercial-scale manufacturing and is building approximately 5 million doses of launch inventory, with anticipated post-launch production capacity of approximately 1 million doses per month.

That means the company is attempting to have significant supply available if and when final regulatory clearance arrives.

$NRXP Has Strengthened Its Financial Position

The company also entered the second half of 2026 with a significantly stronger cash position.

NRx completed an institutionally supported public offering generating approximately $22.3 million in gross proceeds, including the underwriters' full exercise option.

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As of June 30, NRx reported approximately $26.7 million in cash and equivalents, versus $7.8 million at year-end 2025. Management believes existing resources, anticipated clinic revenue and potential ATM utilization can support operations for at least one year.

This provides additional runway as the company simultaneously advances commercial manufacturing, clinical programs and HOPE Therapeutics.

A Much Broader NRx Platform Is Emerging

Over the past three-plus months, investors have watched NRx move through a remarkable sequence of developments:

• FDA: First-cycle ANDA review completed with no drug-related major deficiencies.
• Manufacturing: Commercial-scale production underway with a five-million-dose launch inventory target.
• HOPE: First patients treated using Zeta's advanced TMS navigation technology.
• Robotic TMS: HOPE preparing to deploy Zeta's newly FDA-cleared robotic TMS system.
• NRX-101: FDA Breakthrough Therapy program advancing with TMS.
• DARPA: SPARC-TMS selected for potential non-dilutive funding exceeding $11.5 million.
• Financing: $22.3 million public offering completed.
• GeNeuro: HERV-targeted clinical portfolio expanded within NRx.
• Today's catalyst: European patent awarded for GNK-301 targeting ALS.

The GeNeuro development is particularly interesting because it adds a neurodegenerative disease opportunity to a company whose primary focus has historically been neuropsychiatric conditions.

Investor Perspective

NRx Pharmaceuticals remains a speculative biotechnology investment. Regulatory decisions, clinical outcomes, commercialization, financing requirements and development timelines all carry significant risks, and today's developments do not guarantee future approvals or commercial success.

Nevertheless, the NRXP story is becoming increasingly diversified.

The company is simultaneously approaching a potential commercial milestone with preservative-free ketamine, expanding HOPE Therapeutics, deploying increasingly sophisticated TMS technology, advancing NRX-101 through a potentially significant DARPA-supported program and now highlighting a growing GeNeuro intellectual-property portfolio focused on diseases such as ALS.

Today's European patent award for GNK-301 is therefore more than another patent announcement.

It demonstrates that the GeNeuro platform is beginning to produce tangible intellectual-property milestones while NRx's other programs continue advancing.

At the same time, HOPE Therapeutics is preparing to deploy FDA-cleared robotic TMS technology, creating a potentially powerful connection between NRx's clinical infrastructure and NRX-101 development.

With management continuing to meet investors at major healthcare conferences and multiple regulatory, clinical and commercial milestones ahead, NRx Pharmaceuticals is entering the remainder of 2026 with considerably more catalysts than it had just a few months ago.

For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

Media Contact
Company Name: NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Contact Person: Brian Korb, Managing Partner, astr partners
Email: brian.korb@astrpartners.com
Phone: (917) 653-5122
Country: United States

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