FDA-Cleared Zeta TMS Robotic System Moves Toward Deployment as FDA, DARPA and Commercial Catalysts Converge: NRx Pharmaceuticals (N A S D A Q: NRXP)
The Californer/10356933

MIAMI - Californer -- NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) ("NRx Pharmaceuticals," "NRx" or the "Company"), $NRXP a clinical-stage biopharmaceutical company, announced that its subsidiary, HOPE Therapeutics, Inc. ("HOPE"), is positioned to become the first Interventional Psychiatry organization to deploy Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System, with clinical staff now undergoing training ahead of deployment in Florida.

This latest development adds an important new dimension to the increasingly broad NRx story.

Rather than focusing solely on pharmaceutical development, NRx is building an integrated neuropsychiatric platform combining advanced TMS technology, clinical treatment infrastructure, pharmaceutical development and emerging precision-treatment capabilities. The planned deployment of Zeta Surgical's robotic system represents another step in that strategy and comes at a particularly interesting time for investors.

NRx CEO Jonathan Javitt, M.D., M.P.H., is also taking the company's story directly to the investment community this week, including a scheduled appearance at the Cantor Global Healthcare Conference today, September 11, followed by the H.C. Wainwright 28th Annual Global Investment Conference on September 14.

For investors following N A S D A Q: NRXP, the timing is notable.

The company is approaching a potentially important period with FDA regulatory progress, commercial manufacturing underway, HOPE Therapeutics expansion, advanced TMS deployment, NRX-101 development and a potential DARPA-funded Phase 2/3 program all moving forward.

HOPE Therapeutics and Zeta Surgical: From Technology to Clinical Deployment

Today's announcement is particularly significant because it moves the Zeta Surgical relationship another step toward real-world implementation.

HOPE is preparing its clinical staff for deployment of the newly FDA-cleared Zeta TMS Robotic System in Florida. The system is designed to bring robotic precision and advanced image guidance to TMS treatment, potentially improving the ability of clinicians to consistently target specific areas of the brain.

For NRx, this fits directly into HOPE Therapeutics' broader strategy of developing an advanced Interventional Psychiatry platform.

HOPE has already expanded its Florida clinical footprint and previously became the first commercial site in the United States to deploy Zeta Surgical's FDA-cleared TMS Navigation System. The new robotic system potentially represents another technological step forward.

Why investors may find this important:

• HOPE is moving toward deployment of newly FDA-cleared robotic TMS technology.
• Clinical personnel are already being trained ahead of Florida deployment.
• The technology complements NRx's broader TMS and neuropsychiatric strategy.
• HOPE provides NRx with an operating clinical platform rather than relying solely on pipeline development.
• The technology could become increasingly relevant to the company's NRX-101/TMS development strategy.

FDA Progress Remains the Major Near-Term Catalyst

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While today's HOPE announcement adds significant strategic interest, the company's preservative-free ketamine program remains one of the most important potential near-term catalysts.

On August 7, NRx announced that the FDA had completed its first-cycle review of the company's ANDA for preservative-free ketamine without identifying drug-related major deficiencies.

The remaining FDA question concerns the vial's luer-lock component. NRx has emphasized that the remaining issue is related to the container closure system rather than the ketamine product itself, its ingredients, labeling, Chemistry, Manufacturing and Controls, or clinical data.

The company submitted the requested manufacturer attestation.

Most importantly for investors, NRx has stated that no new clinical, safety or efficacy data are required for ANDA approval.

The company continues to target potential approval and commercialization during 2026.

Commercial Manufacturing Is Already Underway

$NRXP has been preparing for a potential launch before receiving final FDA approval.

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

NRx has also established a commercial launch team and appointed Glenn Tyson as its first Chief Commercial Officer.

This means the company is attempting to position itself to move quickly from regulatory approval to commercial execution.

For a small-cap biotechnology company, that distinction is important.

The story is increasingly becoming about launch readiness, not simply laboratory development.

NRX-101 Could Provide a Second Major Growth Opportunity

The other major component of the NRx pipeline is NRX-101, an oral fixed-dose combination of D-cycloserine and lurasidone.

NRX-101 has received FDA Breakthrough Therapy Designation for suicidal bipolar depression, and NRx is developing the program in conjunction with advanced TMS approaches.

In June, the FDA granted an Expanded Access Protocol for D-cycloserine-based NRX-101 as an augmentation to accelerated TMS for depression.

NRx subsequently announced that its defense subsidiary had been selected by DARPA as prime contractor for the SPARC-TMS program, an FDA-approved Phase 2/3 trial combining NRX-101 with robotic TMS.

The potential non-dilutive funding is expected to exceed $11.5 million, subject to completion of contracting.

The combination of NRX-101 and robotic TMS is particularly interesting in light of today's HOPE Therapeutics announcement, because the company is simultaneously developing the therapeutic program while building access to advanced TMS technology within its clinical platform.

A Stronger Balance Sheet Provides Additional Runway

NRx also significantly strengthened its financial position during 2026.

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

As of June 30, NRx reported approximately $26.7 million in cash and cash equivalents, compared with $7.8 million at year-end 2025.

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Management believes its existing cash resources, anticipated clinic revenue and potential ATM utilization provide at least one year of operating runway.

That additional financial flexibility could be important as NRx moves simultaneously toward potential commercialization and continued clinical development.

A Rapidly Expanding Investor Catalyst List

NRXP investors now have several potential catalysts to monitor:

• Deployment of the FDA-cleared Zeta TMS Robotic System at HOPE Therapeutics
• FDA resolution of the remaining preservative-free ketamine certification
• Potential 2026 commercialization
• Five-million-dose launch inventory
• Manufacturing scale-up toward approximately one million doses monthly
• DARPA contracting and potential $11.5 million-plus non-dilutive funding
• NRX-101 clinical development
• Progress toward the NRX-100 NDA
• Continued HOPE Therapeutics expansion
• Additional investor presentations and institutional awareness

And with management meeting investors at major healthcare conferences this week, the company has a timely opportunity to explain how these initiatives fit together.

Investor Perspective

NRx Pharmaceuticals remains a speculative small-cap biotechnology investment, and FDA decisions, clinical outcomes, financing requirements, manufacturing execution and commercial adoption all carry meaningful risk.

However, the company's story has expanded considerably.

Today's HOPE Therapeutics announcement is another example of that evolution.

NRx is not simply developing therapies in isolation. It is attempting to build an integrated neuropsychiatric ecosystem involving pharmaceutical development, advanced TMS, robotic treatment technology, clinical infrastructure and government-supported research.

The planned deployment of Zeta Surgical's newly FDA-cleared Zeta TMS Robotic System—combined with clinical staff already training for deployment in Florida—gives investors another tangible milestone to watch.

At the same time, the preservative-free ketamine program is approaching a potentially decisive FDA milestone, commercial manufacturing is underway, millions of doses are being prepared for a potential launch, and NRX-101 has gained significant momentum through its FDA designations and potential DARPA-supported clinical program.

That convergence is what makes the current NRXP story particularly compelling.

With CEO Jonathan Javitt appearing before healthcare investors today at the Cantor Global Healthcare Conference, followed by another major investor presentation on September 14, the market will have an opportunity to hear directly from management at a time when several pieces of the NRx strategy are beginning to come together.

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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