Form 8-K

8-K — NRX Pharmaceuticals, Inc.

Accession: 0001437749-26-032042

Filed: 2026-10-05

Period: 2026-09-29

CIK: 0001719406

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Financial Statements and Exhibits

Documents

8-K — nrxp20261005_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ex_1022189.htm)

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0001719406

2026-09-29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 29, 2026

NRX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38302

82-2844431

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification Number)

1201 Orange Street, Suite 600

Wilmington, Delaware

19801

(Address of principal executive offices)

(Zip Code)

(484)254-6134

(Registrant’s telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.424)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of exchange on which registered

Common Stock, par value $0.001 per share

NRXP

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01. Entry into a Material Definitive Agreement.

On September 29, 2026, NRx Defense Systems, Inc. (“NRx Defense”), a subsidiary of NRx Pharmaceuticals, Inc. (the “Company”), entered into a prime contract (the “Contract”) with Defense Advanced Research Projects Agency (“DARPA”) pursuant to which NRx Defense was awarded a contract to conduct the Synaptic Plasticity Augmented Rapid Circuit Stimulation (“SPARC-TMS”) clinical trial.

The Contract has an aggregate value of approximately $11.2 million, of which approximately $6.7 million has been initially obligated by DARPA, with additional funding subject to the availability of appropriations and DARPA’s exercise of funding options. The Contract has an 18‑month performance period and provides for payment upon the achievement and acceptance of specified program milestones. Subject to certain government rights, NRx Defense retains ownership of inventions conceived or first actually reduced to practice under the Contract, while DARPA receives a nonexclusive, nontransferable, irrevocable, paid-up license for governmental purposes. The Contract also grants DARPA specified rights in technical data and computer software developed under the program, subject to certain restrictions applicable to pre-existing proprietary technology. The Contract may be terminated by either party under certain circumstances, including if the program is determined unlikely to achieve its intended objectives.

The SPARC-TMS trial is designed to evaluate a single-day treatment protocol using robotic neuro-navigated transcranial magnetic stimulation in combination with NRX-101, the Company’s investigational drug, for the treatment of treatment-resistant depression. The clinical trial has been approved by the U.S. Food and Drug Administration and is expected to begin enrolling patients.

The description of the Contract does not purport to be complete, and such description is qualified in its entirety by reference to the complete terms of the Contract, which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending September 30, 2026.

On September 30, 2026, the Company issued a press release announcing the award of the Contract. A copy of the press release is attached hereto as Exhibit 99.1.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements may include, among other things, statements regarding the Company’s financial outlook, product development activities, regulatory matters, business prospects, market and industry trends and conditions, and the Company’s strategies, plans, objectives and goals.

Forward-looking statements are based on the current beliefs, expectations, estimates, forecasts and projections of, and assumptions made by and information currently available to, the Company’s management. Words such as “expect,” “anticipate,” “should,” “believe,” “hope,” “target,” “project,” “goal,” “estimate,” “potential,” “predict,” “may,” “will,” “might,” “could,” “would,” “seek,” “plan,” “intend” and similar expressions, or the negative of such terms, are intended to identify forward-looking statements.

Forward-looking statements are subject to significant risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the Company’s limited operating history; its ability to obtain regulatory approval for, develop, manufacture and commercialize its product candidates; the timing and results of regulatory submissions, reviews and decisions; manufacturing difficulties or delays; competition and technological developments; changes in applicable laws and regulations; the Company’s ability to protect and enforce its intellectual property rights; its ability to retain key personnel, manage growth and obtain additional financing; general economic, market and industry conditions; and the risks described under the heading “Risk Factors” in the Company’s filings with the Securities and Exchange Commission. There can be no assurance that any product candidate will receive the necessary regulatory approvals or, if approved, will be commercially successful.

Forward-looking statements speak only as of the date of this Current Report on Form 8-K. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

Number

Description

99.1

Press Release dated September 30, 2026

104

Cover Page Interactive Data File (embedded with the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

NRx Pharmaceuticals, Inc.

Date: October 5, 2026

By:

/s/ Michael Abrams

Name:

Michael Abrams

Its:

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ex_1022189.htm · Sequence: 2

ex_1022189.htm

Exhibit 99.1

NRx Defense Systems, an NRx Company (Nasdaq:NRXP) Awarded $11 Million Dollar DARPA Prime Contract to Evaluate Robotic Magnetic Stimulation in conjunction with NRX-101 for Treatment of Resistant Depression

September 30, 2026 07:00 ET | Source: NRx Pharmaceuticals, Inc.

●

DARPA states that the program, if successful, will fundamentally change the Standard of Care for Treatment Resistant Depression. The Military has recognized that current treatments for depression are not deployable in operational military settings.

●

The SPARC-TMS Single Day treatment protocol, which involves the use of Robotic Neuronavigated Transcranial Magnetic Stimulation (TMS) augmented by NRx’s neuroplastic investigational drug NRX-101, is based on a recently completed randomized-controlled trial funded by DARPA and published real world findings of 91% treatment response and 69% remission at 3 months post treatment with traditional TMS + D-cycloserine (an active ingredient of NRX-101).

●

If the above results are replicated in the SPARC-TMS trial, it has the potential to serve as an FDA registration study for approval of NRX-101 in conjunction with TMS for people with Treatment Resistant Depression

●

NRx Defense Systems is partnered with HOPE Therapeutics (an NRx sister company), Harvard Medical School’s McLean Hospital, Arizona State University, Zeta Surgical Systems, and Neurocare of America.

●

Plans are underway to expand the SPARC-TMS trial to leading military hospitals.

●

NRx Defense systems is led by a team of former senior military officers and former employees of the Office of the Secretary of Defense with advanced degrees in medicine, psychology, and data science.

MIAMI, Sept. 30, 2026 (GLOBE NEWSWIRE) -- NRx Defense Systems, (“NRx Defense”, “NRXD” or “Company” an NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) subsidiary company, today announced the award of an initial $11,177,757.27 contract issued by the Defense Advanced Research Projects Agency, a Branch of the United States Department of War. The underlying clinical trial, the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) trial has been approved by the US Food and Drug Administration (www.clinicaltrials.gov NCT07227103) and will now begin enrolling patients.

The SPARC-TMS trial will be conducted at Harvard Medical School’s McLean Hospital, Arizona State University, and HOPE Therapeutics. Several leading military hospitals will also be affiliated with the study.

The focus of SPARC-TMS is to test whether an entire course of TMS delivered in a single day can effectively treat major depressive disorder when combined with mechanism-guided pharmacologic augmentation with NRX-101. TMS is thought to exert its therapeutic effects primarily through synaptic plasticity – the cellular basis of learning and memory. Synaptic plasticity is mediated by NMDA receptors. NRX-101 combines two drugs that may enhance NMDA receptor function through complementary mechanisms: d-cycloserine, an NMDA receptor partial agonist, and lurasidone, which has been shown to increase NMDA receptor expression through 5-HT7 antagonism. The treatment to be tested requires a single day in an outpatient clinic, involves no psychedelic experience or intense supervision, no anesthesia, and can be delivered by a robotic targeting system originally developed for neurosurgery with precision of 1mm or less. The preamble to the DARPA contract states that,

Current treatments for Treatment Resistant Depression … require weeks of daily outpatient treatment, have modest response rates of 30%-50%, and are not easily deployable in military operational settings… The “nearly universally accessible” nature of a validated one-day TMS treatment suggests a large potential for adoption, aiming to change the standard of care.

NRX-101, the investigational drug to be tested in this trial was originally conceived by NRx Pharmaceuticals as a Breakthrough therapy drug for treatment of suicidal bipolar depression and so far has demonstrated a reduction in both suicidality and akathisia compared to lurasidone a standard of care drug approved by the FDA in bipolar depression. The SPARC-TMS trial has the potential to serve as an FDA registration study for the use of NRX-101 in conjunction with TMS for people with Treatment Resistant Depression. a far larger population of patients, estimated at 8.9 million American adults with an estimated $44 Billion burden of illness.

Military personnel, veterans, and first responders are known to have substantially elevated rates of depression and suicidality, compared to civilians, an issue that has been addressed by the President of the United States, multiple cabinet-level officials, and numerous public service organizations.

The SPARC-TMS project is based on multiple years of research led by NRXD’s Chief Medical Innovation Officer, Prof. Joshua Brown, MD, PhD, who has pioneered the understanding of the interplay between small molecule drugs for improving neuroplasticity and TMS. Prof. Daniel Javitt, NRx’s co-founder originally reported the role of the NMDA receptor in psychiatric disease in 1987.

NRx Defense Systems was founded as a subsidiary of NRx Pharmaceuticals by Prof. Jonathan Javitt, MD, MPH, CEO and founder of NRXP, Prof. Joshua Brown, MD, PhD, and Dr. Dennis McBride, PhD, (CAPT Medical Service Corps US Navy, Retired, former Senior Executive Leader National Defense University and Office of the Secretary of Defense). Dr. McBride served multiple tours of duty, including scientific leadership roles at six military laboratories and as the first behavioral neuroscientist to be named a DARPA program manager during his highly-decorated Navy career. Their team is augmented by Dr. Martin Goodwin, PhD, a psychologist and data scientist who has just completed a decorated tour of duty as District Commodore for the US Coast Guard Auxiliary.

“I am delighted to unite with my former colleagues at DARPA to reinvent the paradigm for treating depression and suicidality for all Americans,” said Dr. McBride, “During my time at DARPA we advanced cognitive-based artificial intelligence with the ambition to use advanced computational techniques to solve humanity’s greatest challenges. It is inspiring to be part of this AI-empowered mission because it will save countless lives.”

“The chance to see fundamental research mature from my laboratory to a technology that has the potential to save lives and end suffering is the dream of any physician scientist,” said Dr. Brown, “while success is far from guaranteed in any clinical trial, DARPA has a long track record of supporting pioneering efforts with far-reaching impact, and their support gives us the strongest possible foundation for success.

About NRx Defense Systems

NRx Defense Systems (NRXD) is a newly-formed US subsidiary established by NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) to serve as a fully-qualified defense contractor focused on treating causes of death and disability in military personnel, veterans, and first responders. NRXD maintains military grade cybersecurity and personnel security clearances suitable for operating within military and first responder environments. The company is led by medical professionals and scientists who are able to understand disease processes at a molecular and data science level and translate that understanding into technologies that can be deployed rapidly, efficiently, and at scale.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in NRx Pharmaceuticals, Inc.'s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:

Brian Korb

Managing Partner, astr partners

(917) 653-5122

brian.korb@astrpartners.com

Martin Goodwin, PhD

Chief Operating Officer

inquiries@nrxdefense.com

1 Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699.

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