Form 8-K - Current report

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) February 7, 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 1.01. Entry into a Material Definitive Agreement.

On February 7, 2024, NeuroRx, Inc., a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. (together, the “Company”), entered into the First Amendment (the “Amendment”) to the Exclusive, Global Development, Supply, Marketing & License Agreement, dated as of June 2, 2023 (the “License Agreement”), with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”), effective as of the same date.

Pursuant to the terms of the Amendment, the Company will receive $5 million of the Milestone Payment (as defined in the License Agreement) in advance, which NRx will use to fund the development of NRX-101 through the phase 2 meeting with the U.S. Food and Drug Administration (“FDA”). As compensation for advancing such portion of the Milestone Payment, Alvogen will receive 4,195,978 warrants to purchase the Company's common stock, at a strike price of $0.40 with a three (3) year term (the “Warrants”). The second portion of the milestone payment, in the amount of $4 million, will be due to the Company within 60 days of Completion of the Type B Meeting (as defined in the License Agreement).

The Company then remains eligible to receive up to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages of annual net sales of NRX-101, subject to achievement of certain sales volumes. Additionally, Alvogen will be responsible for future development and commercialization costs for NRX-101 in treatment of bipolar depression with suicidality.

The foregoing is only a summary of the material terms of the Amendment and does not purport to be complete. The foregoing summary is qualified in its entirety by reference to the complete text of the Amendment, which will be filed at a later date.

Item 8.01 Other Events.

On February 12, 2024, the Company issued a press release announcing its entry into the Amendment and the issuance of the Warrants. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated February 12, 2024
104		Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

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: February 14, 2024	By:	/s/ Stephen Willard
	Name:	Stephen Willard
	Title:	Acting General Counsel

Exhibit 99.1

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)

Companies continue to work collaboratively to advance NRX-101 through registrational trials

NRx remains eligible for an additional $324 million in development and sales milestones, as well as tiered double-digit royalties upon approval and commercialization of NRX-101.

Payment materially extends the Company’s cash runway

RADNOR, Pa., Feb. 12, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced the advance of the first $5 million milestone payment based on the Company’s partnership agreement with Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW).

Under the terms of the updated agreement, the Company will immediately receive $5 million of the first milestone, which NRx will use to fund development of NRX-101 through the phase 2 meeting with FDA. As compensation for advancing the milestone, Alvogen and Lotus will receive 4.1 million warrants to purchase the Company’s common stock, at a strike price of $0.40 with a three (3) year term. The second portion of the milestone will be $4 million and, as before, be triggered by a positive response to the Company’s planned end of phase 2 meeting with FDA.

NRx then remains eligible to receive up to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages on Net Sales, subject to achievement of certain sales volumes. Additionally, Alvogen and Lotus will be responsible for future development and commercialization costs for NRX-101 in treatment of bipolar depression with suicidality.

“In a market environment where biotech companies have been increasingly challenged to fund clinical development, we appreciate the confidence of partners that share our view that NMDA-antagonist drugs potentially represent a new and potent class of medicines to treat bipolar depression with suicidality. Over the past six months, NRx, Lotus, and Alvogen have formed a close working relationship and we share a joint commitment to bringing this potentially life-saving drug to patients.” said Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals.

Additional information can be found on the Company website’s Investor Relations page Investor Q&A.

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 and Lotus 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 NRX-100 (IV 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.

For further information: Jeremy Feffer, LifeSci Advisors, Inc., jfeffer@lifesciadvisors.com, Matthew Duffy, Chief Business Officer, mduffy@nrxpharma.com

Cover	Feb. 07, 2024
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 07, 2024
Entity File Number	001-38302
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
Entity Address, State or Province	DE
Entity Address, Postal Zip Code	19801
City Area Code	484
Local Phone Number	254-6134
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NRXP
Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants to purchase one share of Common Stock
Trading Symbol	NRXPW
Security Exchange Name	NASDAQ