8-K

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): November 14, 2022 (November 12, 2022)

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 x

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 November 12, 2022, NRx Pharmaceuticals, Inc. (“NRx” or the “Company”) entered into a Settlement Agreement and Asset Purchase Agreement (“APA”) with Relief Therapeutics Holding AG and Relief Therapeutics International (the “Relief Parties”) to settle the outstanding lawsuit with respect to the Binding Collaboration Agreement dated September 18, 2020 between the Company and the Relief Parties (the “Collaboration Agreement”).

Under the APA, the Company has agreed to transfer to the Relief Parties all of the Company’s interest in ZYESAMI (or the “Product” as such term is defined in the Collaboration Agreement), including intellectual property, FDA applications, clinical trial data, drug and API inventory and certain contractual rights. The Company has agreed to refrain from developing any product for any indication that uses or otherwise exploits the Product without the Relief Parties’ consent.

The Relief Parties have agreed to use commercially reasonable efforts to develop, market, and commercialize the Product, but has sole discretion to select the indications for which it will seek to develop the Product. Although the Company intends to monitor the progress of the Relief Parties under the APA and enforce the Company’s rights thereunder, there can be no assurances that the Relief Parties will be successful at commercializing the Product.

Upon commercial launch of the Product by the Relief Parties or any of their affiliates, licensees or sublicensees (or upon authorization of use for any indication of the Product other than COVID-19), the Company is entitled to receive milestone payments in stages up to an aggregate amount of $13.0 million. The Relief Parties have also agreed to pay royalties to NRx on aggregate net sales of all Products, subject to a cap on royalty payments of $30.0 million in the aggregate. In addition, Relief is obligated to use commercially reasonable efforts to continue NRx’s existing Right to Try Program for at least two (2) years after the closing of the APA.

Mutual indemnity provisions in the APA will protect each party from any breaches of the settlement arrangements by the other party, provided, that the Company’s indemnity obligations will not start until the Relief Parties have begun making royalty or milestone payments to NRx, subject to certain exceptions. With respect to the Company, there is an indemnity threshold such that the Company will not be liable for any indemnity claims until such claims are in excess of $0.5 million (and then only for the amount above $0.5 million). The Company’s indemnity obligation is capped at $2.0 million with respect to breaches of representations and warranties and $3.0 million with respects to breaches of covenants or other agreements. Additionally, subject to certain exceptions, the Company’s indemnity obligations cannot exceed the amount that the Relief Parties actually pay to the Company for milestone and royalty payments.

The parties have 30 days to implement the agreed actions and achieve closing under the APA, at which time all claims and counterclaims between the Company and the Relief Parties will be dismissed with prejudice.

The foregoing summary of the Settlement Agreement and APA is qualified in its entirety by reference to the forms of such agreements, which will be filed with the Company’s report for the fiscal year ending December 31, 2022.

On November 14, 2022, the Company and Relief issued a joint press release announcing the Settlement. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 2.02 Results of Operations and Financial Condition

On November 14, 2022, the Company announced its financial results for the third quarter 2022. The full text of the press release is furnished as Exhibit 99.2 to this report.

The information furnished under this Item 2.02, including Exhibit 99.2, 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 under that section and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated by specific reference in any such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Joint Press Release of NRx Pharmaceuticals, Inc. and Relief Therapeutics
99.2	Press Release of NRx Pharmaceuticals, Inc.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: November 14, 2022	By:	/s/ Michael Kunz
	Name:	Michael Kunz
	Title:	General Counsel

EX-99.1

EXHIBIT 99.1

 

Ad hoc announcement pursuant to Art. 53 LR

Relief Therapeutics Holding SA and NRx Pharmaceuticals, Inc. Announce Execution of Definitive Settlement Agreements

Geneva, Switzerland and Radnor, Pennsylvania, November 14, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTD) ("Relief"), and NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) ("NRx Pharmaceuticals"), today announced that they have entered into definitive settlement agreements to resolve their pending litigation. As part of the settlement, at a closing to be held within the next 30 days, (i) NRx Pharmaceuticals will transfer to Relief all of the assets that it previously used in its aviptadil development program, including its regulatory filings, patent applications, clinical data, and the formulation of the aviptadil product it was previously developing, (ii) Relief will have the exclusive right and control going forward and the obligation to use commercially reasonable efforts to develop and commercialize an aviptadil product, (iii) Relief has agreed to use commercially reasonable efforts to continue the existing Right to Try Program for aviptadil in the United States for at least 2 years, (iv) Relief will pay NRx Pharmaceuticals milestone payments if it can successfully obtain commercial approval of an aviptadil product (whether for COVID-19 or any other indication), (v) Relief will pay NRx Pharmaceuticals royalties based on a percentage of future sales of an aviptadil product (whether for COVID-19 or any other indication), up to a maximum of $30 million in the aggregate, (vi) NRx Pharmaceuticals has agreed not to compete in the development of an aviptadil product in the future, and (vii) at the closing, Relief and NRx Pharmaceuticals will dismiss their pending litigation. There can be no assurances that Relief will be successful at commercializing the aviptadil product.

About Relief Therapeutics

Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases, and connective tissue disorders. Relief’s diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (“PKU”). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”). Relief also continues to develop aviptadil for several rare pulmonary

indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa (“EB”), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTD. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

About NRx Pharmaceuticals

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders, specifically suicidal depression and post-traumatic stress disorder (PTSD). The company’s lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain’s NMDA receptor and is being investigated in a Phase 3 trial under a Food and Drug Administration ("FDA") Special Protocol Agreement and Breakthrough Therapy Designation in patients with bipolar depression and acute suicidal ideation, an indication for which the only approved treatment is electroshock therapy. NRx Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute Suicidality, potentially a substantially broader indication. The Breakthrough Therapy Designation and Special Protocol Agreement were awarded by the FDA based on the Company’s prior STABIL-B trial that demonstrated substantial improvement over available therapy in reducing depression and suicidality compared to placebo when patients were treated with NRX-101 after a single dose of ketamine.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the parties can successfully close their settlement, and (ii) those factors described in Relief's and NRx Pharmaceuticals' reports to the Securities and Exchange Commission under the Securities Exchange Act of 1934 could adversely affect Relief and NRx, respectively. Copies of Relief's and NRx's filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief and NRx do not undertake any obligation to update the information contained herein, which speaks only as of this date.

CONTACT:

RELIEF THERAPEUTICS Holding SA Jack Weinstein Chief Financial Officer and Treasurer contact@relieftherapeutics.com NRX PHARMACEUTICALS, INC. Molly Cogan Sr. Director, Global Communications mcogan@nrxpharma.com

FOR MEDIA/INVESTOR INQUIRIES:

LifeSci Advisors	Stern Investor Relations
Irina Koffler	Suzanne Messer
ikoffler@lifesciadvisors.com	suzanne.messere@sternir.com
+1-917-734-7387

EX-99.2

EXHIBIT 99.2

 

NRx Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

· Completed a technology transfer, submitted a new manufacturing file to the United States (“U.S.”) Food and Drug Administration (“FDA”), and released new drug produced with processes designed to support commercial-stage manufacturing of a Phase 3 investigational drug

· On track to report data from ongoing Phase 2 clinical trial of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation and behavior (SSIB) in 1Q 2023

· Company has received numerous partnering inquiries for NRX-101

· Plan to initiate registrational Phase 3 clinical trial of NRX-101 in patients with bipolar depression with acute suicidal ideation and behavior (ASIB) by year-end; data readout expected in 3Q 2023

· Commenced Phase 2 clinical trial planning of NRX-101 for post-traumatic stress disorder (“PTSD”)

· Ended quarter with $18.2 million in cash and cash equivalents and announced completion of a subsequent unsecured debt financing on November 7, 2022, providing net proceeds of $10.0 million to support the NRx Pharmaceuticals’ pipeline of life-saving therapeutics

RADNOR, Pa., November 14, 2022 – NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced its financial results for the third quarter of 2022 and provided a business and clinical update.

“In recent months, NRx Pharmaceuticals has made substantial progress advancing our clinical development plans for our lead investigational compound, NRX-101, in multiple psychiatric indications,” said Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. “Today, someone in the U.S. someone attempts suicide every 27 seconds, and someone dies of suicide every 11 minutes and there is no approved medication for suicidal bipolar depression or PTSD. The only FDA-approved treatment for suicidal bipolar depression remains electroshock therapy. The FDA has granted NRX-101 a Breakthrough Therapy Designation with an accompanying Special Protocol Agreement for treatment of patients with bipolar depression and acute suicidality. If approved, we aim to offer this potentially transformative medicine to patients in 2024. During this exciting time at NRx Pharmaceuticals, we remain committed to our mission of meeting the needs of underserved patients with life-threatening central nervous system (“CNS”) disorders.”

NRx Pharmaceuticals plans to advance NRX-101 to approval with multiple near-term catalysts on track for the fourth quarter, including the initiation of a Phase 2b/3 SPA trial (a registrational Phase 3 clinical trial) for NRX-101 in patients with bipolar depression with acute suicidality and a Phase 2 trial for NRX-101 in PTSD, a secondary indication recently announced in September. Additionally, the Company expects to report top-line clinical data for the Phase 2 trial of NRX-101 in patients with bipolar depression with sub-acute suicidality in the first quarter of 2023.

Third Quarter Clinical and Regulatory Highlights

In March 2022, NRx Pharmaceuticals announced a primary focus on its psychiatry franchise and the late-stage development of NRX-101 for the treatment of bipolar depression in patients with suicidality. NRX-101 is a fixed dose combination of D-cycloserine, an NMDA antagonist, and lurasidone, a 5-HT_2A atypical antipsychotic and antidepressant, for the maintenance of remission from severe bipolar depression

following initial stabilization with ketamine. The previously undiscovered synergy between these two drug classes in the treatment of CNS disorders, combined with the efficacy of D-cycloserine in the treatment of depression and PTSD, is the subject of 47 issued patents and more than 43 pending patents owned by or licensed to NRx Pharmaceuticals.

NRX-101 Lead Indication – Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB) After Initial Stabilization with ketamine

· In 2017, NRX-101 received an investigational new drug (IND) clearance by the U.S. Food and Drug Administration (FDA) and a Phase 2b/3 clinical trial commenced for bipolar depression with ASIB. Later that year, the FDA granted NRX-101 a Fast Track designation for the same indication.

· In 2018, the FDA provided a Letter of Support to the Company encouraging the development of Glutamine+Glutamate (Glx) as a pharmacodynamic biomarker for depression. The letter referenced published and unpublished data demonstrating a significant association between clinical symptoms of depression and levels of brain Glx. 

· In the STABIL-B Phase 2 trial, the Phase 2 portion of the Phase 2b/3 trial, patients with bipolar depression and ASIB received either NRX-101 or lurasidone after an intravenous infusion of NRX-100 (ketamine). The proof-of-concept data presented at the American Congress of Neuropsychopharmacology in 2018 demonstrated with statistical significance that NRX-101 treated patients experienced lower depression scores and did not relapse.

· Based on STABIL-B findings, the FDA granted NRX-101 Breakthrough Therapy Designation and a Special Protocol Agreement (“SPA”) for bipolar depression in patients with ASIB, which affects ~150K-180K patients per year in the U.S. The Breakthrough Therapy Designation allows for an expedited rolling submission of a new drug application (“NDA”) for investigational drugs that have demonstrated substantial improvement over existing approved therapies, and the SPA allows for a single registrational trial of NRX-101 in severe bipolar depression in patients with ASIB after stabilization with ketamine, using a protocol similar to the STABIL-B trial with a patient population of less than 100.

· NRx Pharmaceuticals plans to initiate the registrational Phase 3 portion of the Phase 2b/3 clinical trial of bipolar depression in patients with ASIB in 4Q 2022. The trial is designed as a double-blind, adaptive trial with a 2:1 randomization of NRX-101 vs. lurasidone alone in 72 patients. The study is expected to find that following initial stabilization with a single infusion of ketamine (NRX-100), treatment with NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression and suicidality as measured by the MADRS-10 depression scale and the CGI suicidality scale.

· NRx Pharmaceuticals announced that it has transferred Phase 3 commercial drug manufacturing processes to the U.S. and released Phase 3 drug manufactured via the expected commercial-stage processes. NRx Pharmaceuticals has submitted its manufacturing file to the FDA. This investigational drug manufactured according to these new processes will be used in the upcoming Phase 3 trial.

· A data readout from the registrational Phase 3 clinical trial is expected in 3Q 2023. Assuming that efficacy endpoints and safety are met, NRx Pharmaceuticals plans to initiate submission of a NDA to the FDA by year-end 2023, as allowed under Breakthrough Therapy Designation.

· Company has received numerous partnering inquiries for NRX-101.

NRX-101 Indication – Bipolar Depression in Patients with Sub-acute Suicidal Ideation and Behavior (SSIB)

· A Phase 2 double-blind study completed in 2018 demonstrated the ability of NRX-101 to improve depression and suicidality over 6 weeks when taken twice daily over lurasidone alone after an initial stabilization with ketamine. The current study involving patients with bipolar depression and sub-acute suicidality (not requiring hospitalization) does not include the use of ketamine; all patients are being treated in an outpatient setting.

· Insights from this study will guide NRx Pharmaceuticals in the potential expansion of the indication for NRX-101 to bipolar depression with SSIB, which represents a significantly 2-3x larger patient population than those with bipolar depression and ASIB. A data readout of this study is expected by 1H 2023.

NRX-101 Indication – Post Traumatic Stress Disorder

· In September 2022, NRx announced plans to investigate PTSD as an additional indication. The Company expects to commence Phase 2 clinical trial planning of NRX-101 in PTSD in 4Q 2022.

• Depression in PTSD may be driven by pathways that are similar to those that drive depression in other conditions (NMDA and 5-HT2A). Additionally, approximately 10% of patients with PTSD may experience suicidality, especially those with severe PTSD.

• In a preclinical PTSD study, D-cycloserine, a component of NRX-101, demonstrated the ability to extinguish recurring images of traumatic events, also known as fear memory, in a validated WKY model of PTSD.

Corporate Updates

· In August 2022, the Company appointed Mr. Willard as Chief Executive Officer and as a member of the Board of Directors. Mr. Willard brings a wealth of experience in the management of publicly traded biotechnology companies, together with his background in law and finance. Most recently, Mr. Willard previously served as CEO of Cellphire Therapeutics, where he grew the company and shepherded their revolutionary human platelet platform through key clinical trials, growing the company and enhancing shareholder value. For eight years prior to that he served as CEO of NASDAQ traded Flamel Technologies.

· Completed agreement with Relief Therapeutics Holding SA regarding pending litigation. Further information was contained in a joint press release issued on November 13, 2022, and will be included in the form 8-K to be filed with the Securities and Exchange Commission upon settlement.

Third Quarter 2022 Financial Results

Financial Results for the Third Quarter ended September 30, 2022

· Research and development (R&D) expenses for the third quarter totaled $4.1 million compared to $6.3 million for the comparable quarter in 2021. The decrease in R&D expenses related primarily to a decrease clinical trials and development expenses related to ZYESAMI®.

· General and administrative (G&A) expenses for the third quarter totaled $5.0 million compared to $13.8 million for the comparable quarter in 2021. The decrease in G&A expenses was primarily related to a decrease in stock-based compensation and consultant fees.

· Other income for the third quarter totaled $0.06 million compared to $17.0 million for the comparable quarter in 2021. The decrease in other income was primarily related to a decrease in the fair value of certain Substitute Warrants and the Placement Warrants assumed pursuant to the Merger Agreement because of lower stock price levels.

• Net loss for the third quarter was $9.1 million compared with a net loss of $37.0 million for the comparable quarter in 2021.

Financial Results for Nine Months ended September 30, 2022

· R&D expenses for the nine months ended September 30, 2022, totaled $12.6 million compared to $13.8 million for the nine months ended September 30, 2021. The decrease in R&D expenses related primarily to a decrease in regulatory and process development expenses related to ZYESAMI® and the BriLife vaccine.

· G&A expenses for the nine months ended September 30, 2022, totaled $21.9 million compared to $28.4 million for the nine months ended September 30, 2021. The decrease in G&A expenses was primarily related to a decrease in consultant fees and stock-based compensation.

· Settlement expenses for the nine months ended September 30, 2022, totaled $0.0 million compared to $21.4 million for the nine months ended September 30, 2021, related to the GEM Warrant reflecting the incremental value through the date of issuance.

· Other income for the nine months ended September 30, 2022, totaled $4.9 million compared to $0.2 million for the nine months ended September 30, 2021. The increase in other income was primarily related to a decrease in the fair value of the Earnout Cash liability compared to the nine months ended September 30, 2021.

· Net loss for the nine months ended September 30, 2022, was $29.5 million compared with a net loss of $62.7 million for the nine months ended September 30, 2021.

· As of September 30, 2022, cash was $18.2 million compared to $27.6 million as of December 31, 2021. NRx Pharmaceuticals announced completion of a subsequent unsecured debt financing on November 7, 2022, with net proceeds of $10.0 million. The Company intends to use the net proceeds to support its NRX-101 development programs for the treatment of suicidal bipolar depression and PTSD. The Company believes that it has sufficient funds to support our ongoing clinical development plans for at least the next 12 months, and if necessary, the ability to reduce non-core G&A operating expenses.

Conference Call and Webcast Details

A live webcast of the conference call will be available on the Company’s website at NRx Pharmaceuticals Third Quarter Earnings Webcast/Call. An archive of the webcast will be available on the Company’s website. 

Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1 (833) 630-1956 or internationally +1 (412) 317-1837.

About NRX-101

Up to 50% of individuals with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. The only FDA-approved treatment for patients with bipolar depression and acute suicidal ideation & behavior (ASIB) remains electroconvulsive therapy (ECT). Conventional antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101 is a patented, oral, fixed dose combination of D-cycloserine and lurasidone, neither of which has shown addiction potential. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from the FDA for the treatment of severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other effective therapy.

NRX-101 is one of the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as PTSD and other indications. To date, NRX-101 is the only oral NMDA investigational medicine focused on bipolar depression in patients with acute and sub-acute suicidality.

NRx Pharmaceuticals expects to begin its registration trial for NRX-101 under a SPA in 4Q 2022 or early Q1 2023.

About NRx Pharmaceuticals

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders, specifically suicidal depression and post-traumatic stress disorder (PTSD). The company’s lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain’s NMDA receptor and is being investigated in a Phase 3 trial under a Food and Drug Administration ("FDA") Special Protocol Agreement and Breakthrough Therapy Designation in patients with bipolar depression and acute suicidal ideation, an indication for which the only approved treatment is electroshock therapy. NRx Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute Suicidality, potentially a substantially broader indication. The Breakthrough Therapy Designation and Special Protocol Agreement were awarded by the FDA based on the Company’s prior STABIL-B trial that demonstrated substantial improvement over available therapy in reducing depression and suicidality compared to placebo when patients were treated with NRX-101 after a single dose of ketamine.

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 CONTACT
Molly Cogan
Sr. Director, Global Communications
mcogan@nrxpharma.com

INVESTOR RELATIONS
Suzanne Messere
Investor Relations

suzanne.messere@sternir.com

NRX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

	September 30, 2022			December 31, 2021
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	18,249		$	27,605
Prepaid expenses and other current assets		6,552			5,109
Total current assets		24,801			32,714
Other assets		23			15
Total assets	$	24,824		$	32,729
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,168		$	3,687
Accrued and other current liabilities		5,067			2,375
Accrued clinical site costs		751			469
Earnout Cash liability		—			4,582
Warrant liabilities		56			292
Note payable and accrued interest		—			518
Total liabilities	$	8,042		$	11,923
Preferred stock, $0.001 par value, 50,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		—			—
Common stock, $0.001 par value, 500,000,000 shares authorized; 67,641,314 and 58,810,550 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		68			59
Additional paid-in capital		229,470			203,990
Accumulated deficit		(212,756	)		(183,243	)
Total stockholders’ equity		16,782			20,806
Total liabilities and stockholders' equity	$	24,824		$	32,729

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

NRX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)

(Unaudited)

	Three months ended						Nine months ended
	September 30,						September 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	4,129		$	6,276		$	12,571		$	13,844
General and administrative		5,012			13,823			21,876			28,382
Settlement expense		—			—			—			21,366
Reimbursement of expenses from Relief Therapeutics		—			—			—			(771	)
Total operating expenses		9,141			20,099			34,447			62,821
Loss from operations		(9,141	)		(20,099	)		(34,447	)		(62,821	)
Other (income) expenses:
Gain on extinguishment of debt		—			—			—			(121	)
Interest income		(95	)		—			(119	)		—
Interest expense		—			5			3			16
Change in fair value of warrant liabilities		37			16,537			(236	)		(823	)
Change in fair value of Earnout Cash liability		—			408			(4,582	)		763
Total other (income) expenses		(58	)		16,950			(4,934	)		(165	)
Net loss		(9,083	)		(37,049	)		(29,513	)		(62,656	)
Deemed dividend		—			—			—			(255,822	)
Net loss attributable to common stockholders	$	(9,083	)	$	(37,049	)	$	(29,513	)	$	(318,478	)
Net loss per share:
Basic	$	(0.14	)	$	(0.72	)	$	(0.45	)	$	(1.45	)
Diluted	$	(0.14	)	$	(0.72	)	$	(0.45	)	$	(1.45	)
Net loss per share attributable to common stockholders:
Basic	$	(0.14	)	$	(0.72	)	$	(0.45	)	$	(7.36	)
Diluted	$	(0.14	)	$	(0.72	)	$	(0.45	)	$	(7.36	)
Weighted average common shares outstanding:
Basic and diluted		66,449,593			51,739,452			65,532,409			43,290,675

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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Document Type	8-K
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Document Period End Date	Nov. 12, 2022
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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
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	true
Elected Not To Use the Extended Transition Period	false
Common Stock, par value $0.001 per share
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NRXP
Security Exchange Name	NASDAQ
Warrants to purchase one share of Common Stock
Title of 12(b) Security	Warrants to purchase one share of Common Stock
Trading Symbol	NRXPW
Security Exchange Name	NASDAQ