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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

 

 

 

 

(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):

 

 

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

 

 

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.

 

 

 

 

 

 

 

 

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.