NRXP NRX Pharmaceuticals Inc

 

 

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) January 16, 2024

 

 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 No.)

 

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)

 

N/A

(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:

 

	¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	¨	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(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		NRXP		The Nasdaq Stock Market LLC
Warrants to purchase one share of Common Stock		NRXPW		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 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

On October 17, 2023, NRx Pharmaceuticals, Inc. (the “Company”) received formal notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the Company’s non-compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Rule”), the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company timely requested a hearing before the Panel, which hearing was held on January 4, 2024.

 

On January 16, 2024, the Panel granted the Company’s request for an exception to the Nasdaq listing rules until April 16, 2024, to demonstrate compliance with the Rule. Such exception is subject to the following conditions:

 

1.

The Company filing all necessary documentation required to transfer its listing from the Nasdaq Global Market to the Nasdaq Capital Market on or before January 19, 2024; and

 

2.

The Company demonstrating compliance with Listing Rule 5550(a)(2) on or before April 16, 2024.

 

We are diligently working to evidence compliance with the Rule; however, there can be no assurance that the Panel will determine to continue the Company’s listing or that the Company will be able to evidence compliance with the applicable listing criteria within the time period of any extension that may be granted by the Panel.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. Actual results could differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to: inability of the Company to achieve any of the potential developments identified above; the timing for achieving the potential developments identified above; there is no assurance as to how the potential developments will impact the Company's stock price; and other factors, including risks and uncertainties with respect to the Company, set forth in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements. The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

 

Item 7.01. Regulation FD Disclosure.

 

On January 17, 2024, the Company issued a press release announcing the Panel’s decision. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

The information set forth in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release, dated January 17, 2024
104		Cover Page Interactive Data File (formatted as Inline XBRL)

 

 

SIGNATURE

 

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

 

	NRX PHARMACEUTICALS, INC.
Date: January 23, 2024	By:	/s/ Stephen Willard
	Name:	Stephen Willard
	Title:	Acting General Counsel

 

 

 

Exhibit 99.1

 

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Receipt of Positive Nasdaq Listing Determination

 

RADNOR, Pa., January 17, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for suicidal depression, chronic pain, and PTSD, today announced that on January 16, 2024, the Company was notified by The Nasdaq Stock Market LLC (“Nasdaq”) that the Nasdaq Hearings Panel (the “Panel”) granted the Company’s request for the transfer of its listing to The Nasdaq Capital Market, subject to the Company evidencing compliance with all applicable criteria for continued listing on the Capital Market tier, including the $35 million in market value of listed securities (MVLS) and the $1.00 bid price requirements. The Company believes it has already satisfied the market value of listed securities requirement and is working to evidence compliance with the minimum bid price requirement by April 16, 2024, as required by the Panel’s decision. An issuer must evidence compliance with the minimum threshold for at least ten consecutive business days to be deemed by Nasdaq to have complied with the applicable requirement.

 

“NRx is pleased to share this encouraging news with our shareholders as we continue to meet our drug development milestones as set outlined in our recent communications (NRx Corporate Presentation). This quarter we aim to file our first New Drug Application for NRX-100 (ketamine) for treatment of acute suicidal depression and look forward to announcing top line results from our phase 2b/3 trial of NRX-101 (D-cycloserine/lurasidone) in the treatment of suicidal bipolar depression. These milestones, together with additional updates, are anticipated in advance of the Nasdaq compliance date,” said Stephen Willard, JD, CEO of NRx.

 

About NRx Pharmaceuticals

 

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

 

NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

 

Cautionary Note Regarding Forward-Looking Statements

 

This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management.

 

 

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

 

CORPORATE CONTACTS

 

Jeremy Feffer

LifeSci Advisors, Inc.

jfeffer@lifesciadvisors.com

 

Matthew Duffy

Chief Business Officer

mduffy@nrxpharma.com

 

 

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Document Information [Line Items]
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Entity Registrant Name	NRX PHARMACEUTICALS, INC.
Entity Central Index Key	0001719406
Entity Tax Identification Number	82-2844431
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1201 Orange Street
Entity Address, Address Line Two	Suite 600
Entity Address, City or Town	Wilmington
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Entity Address, Postal Zip Code	19801
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Pre-commencement Issuer Tender Offer	false
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Title of 12(b) Security	Common Stock, par value $0.001 per share
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Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants to purchase one share of Common Stock
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