Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosures.
In designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of the end of the period covered by this Annual Report on Form 10-K under the supervision, and with the participation, of our management, including our Chief Executive Officer (who serves as our principal executive officer) and our Chief Financial Officer (who serves as our principal financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures.
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K in providing reasonable assurance of achieving the desired control objectives.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal executive officer and principal financial officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:
(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisitions, use or disposition of our assets that could have a material effect on the financial statements.
Internal control over financial reporting has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
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Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In making the assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework (2013) . Based on the results of this assessment, management (including our Chief Executive Officer and our Chief Financial Officer) has concluded that, as of December 31, 2022, our internal control over financial reporting was effective.
Remediation of Material Weakness
To address the previously reported material weakness in internal control over financial reporting described in Part II, Item 9A of our 2021 Form 10-K, we performed risk assessments, designed and implemented new controls, enhanced existing controls, and improved reporting processes. Based on the actions taken, as well as the evaluation of the design and operating effectiveness of the new controls, we determined that the material weakness has been remediated as of December 31, 2022.
(b) Changes in Internal Control Over Financial Reporting
During 2022, we tested and adopted changes to our internal control over financial reporting related to our remediation efforts described above that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Other than as described in the immediately preceding sentence, we did not make any additional such changes in internal control over financial reporting during the three months ended December 31, 2022.
Item 9B. Other Information
None.
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Part III
Item 10. Directors, Executive Officers, and Corporate Governance
The information required by this Item 10 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 11. Executive Compensation
The information required by this Item 11 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference. Please refer to the proxy for more information.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item 12 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item 13 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services ( KPMG LLP , Short Hills, NJ , PCAOB Auditor ID: 185 )
The information required by this Item 14 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
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Part IV.
Item 15. Exhibits, Financial Statement Schedules
15(a)(1) Financial Statements. The following consolidated financial statements, related notes, report of independent registered public accounting firm and supplementary data are set forth in Item 8. Financial Statements and Supplementary Data in this annual report:
• Report of Independent Registered Public Accounting Firm on the Consolidated Financial Statements
• Consolidated Balance Sheets
• Consolidated Statement of Operations
• Consolidated Statements of Stockholders’ Equity (Deficit)
• Consolidated Statements of Cash Flows
• Notes to Consolidated Financial Statements
15(a)(2) Financial Statement Schedules. Schedules are omitted because they are not required or because the information is provided elsewhere in the financial statements. The financial statements of unconsolidated subsidiaries are omitted because, considered in the aggregate, they would not constitute a significant subsidiary.
Incorporated by Reference Exhibit
Exhibit Number
Description
Form
Exhibit
Filing
Date
File
Herewith
3.1
Second Amended and Restated Certificate of Incorporation
8-K
3.1
05/28/2021
3.2
Second Amended and Restated By-Laws
8-K
3.2
05/28/2021
4.1
Warrant Agreement, dated as of November 20, 2017, by and between BRPA and Continental Stock Transfer & Trust Company
8-K
4.2
11/22/2017
4.2
Form of Unit Purchase Option, dated November 20, 2017, with EarlyBirdCapital, Inc. and its designees
8-K
4.3
11/22/2017
4.3
Common Stock Purchase Warrant, dated March 9, 2023 by and between NRX Pharmaceuticals, Inc. and Purchasers
8-K/A
4.1
03/14/2023
10.1
Form of Securities Purchase Agreement, dated as of August 19, 2021, by and among the Company and the Selling Securityholders.
8-K
10.1
08/24/2021
10.2
Form of Preferred Investment Options, dated as of August 23, 2021, by and among the Company and the Selling Securityholders.
8-K
10.2
08/24/2021
10.3
Form of Registration Rights Agreement, dated as of August 19, 2021, by and among the Company and the Selling Securityholders.
8-K
10.3
08/24/2021
10.4
Form of Lock-Up Agreement, dated as of August 19, 2021, by and among the Company, Jonathan Javitt and Daniel Javitt.
8-K
10.4
08/24/2021
10.5
Stock Escrow Agreement, dated November 20, 2017, between BRPA, Big Rock Partners Sponsor, LLC and Continental Stock Transfer & Trust Company
8-K
10.2
11/22/2017
10.6
Registration Rights Agreement among BRPA and Big Rock Partners Sponsor, LLC
8-K
10.3
11/22/2017
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Incorporated by Reference Exhibit
Exhibit Number
Description
Form
Exhibit
Filing
Date
File
Herewith
10.7
Agreement, dated November 17, 2018, among BRPA, Big Rock Partners Sponsor, LLC and BRAC Lending Group LLC
8-K
10.1
11/20/2018
10.8
Stock Escrow Agent Letter, dated November 17, 2018
8-K
10.2
11/20/2018
10.9
Registration Rights Assignment Agreement, dated November 17, 2018
8-K
10.3
11/20/2018
10.10
Amendment to the Stock Escrow Agreement, dated May 24, 2021, among BRPA, Continental Stock Transfer & Trust Company, and the stockholder parties thereto
8-K
10.6
05/28/2021
10.11
Lock-up Agreement, dated May 24, 2021, by and between BRPA and the stockholder parties identified therein
8-K
10.7
05/28/2021
10.12
Registration Rights Agreement, dated May 24, 2021, by and among NRx Pharmaceuticals, Inc., certain equityholders of the Registrant named therein and certain equityholders of NeuroRx
named therein
8-K
10.8
05/28/2021
10.13
Sponsor Agreement, dated May 24, 2021, by and among BRPA, the Big Rock Partners Sponsor, LLC, and BRAC Lending Group LLC
8-K
10.9
05/28/2021
10.14
NRx Pharmaceuticals, Inc. 2021 Omnibus Incentive Plan
S-4
10.22
05/21/2021
10.15
Form of Subscription Agreement
8-K
10.1
03/15/2021
10.16
Development and License Agreement, dated as of May 2, 2016, between Glytech LLC and NeuroRx
S-4
10.24
05/21/2021
10.17
Amendment to Development and License Agreement, dated as of October 19, 2016, between Glytech LLC and NeuroRx
S-4
10.25
05/21/2021
10.18
Second Amendment to Amended and Restated Development and License Agreement, dated as of June 13, 2018, between Glytech LLC and NeuroRx
S-4
10.26
05/21/2021
10.19
Third Amendment to Amended and Restated Development and License Agreement, dated as of April 16, 2019, between Glytech LLC and NeuroRx
S-4
10.27
05/21/2021
10.20
Fourth Amendment to Amended and Restated Development and License Agreement, dated as of December 31, 2020, between Glytech LLC and NeuroRx
S-4
10.28
05/21/2021
10.21
Exclusive License Agreement, dated as of April 16, 2019, by and between NeuroRx and Sarah Herzog Memorial Hospital Ezrat Nashim
S-4
10.29
05/21/2021
10.22
License and Option Agreement, dated as of September 1, 2020, between The Research Foundation For The State University of New York and NeuroRx
S-4
10.30
05/21/2021
10.23
Binding Collaboration Agreement, dated as of September 18, 2020, between Relief Therapeutics Holding Aktiengesellschaft and its wholly owned subsidiary Therametrics Discovery
Aktiengesellschaft and NeuroRx
S-4
10.31
05/21/2021
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Incorporated by Reference Exhibit
Exhibit Number
Description
Form
Exhibit
Filing
Date
File
Herewith
10.24
Exclusive Distribution Agreement, dated as of September 25, 2020, between NeuroRx and Cardinal Health 105, Inc.
S-4
10.32
05/21/2021
10.25
Executive Employment Agreement, dated May 20, 2015, between NeuroRx and Jonathan C. Javitt
S-4
10.33
05/21/2021
10.26
“Work for Hire” Agreement, dated as of March 1, 2016, between NeuroRx and REBes Consulting LLC — Robert Besthof
S-4
10.34
05/21/2021
10.27
Amendment to “Work for Hire” Agreement, dated as of October 23, 2016, between NeuroRx and 20REBes Consulting LLC — Robert Besthof
S-4
10.35
05/21/2021
10.28
Consulting Agreement, dated as of January 1, 2021, between NeuroRx and Del Buono Legal, PLLC
S-4
10.36
05/21/2021
10.29
Feasibility Study and Material Transfer Agreement, dated as of January 6, 2021, by and between NeuroRx and TFF Pharmaceuticals, Inc.
S-4
10.37
05/21/21
10.30
Manufacturing Supply Agreement, dated as of August 25, 2020, by and among NeuroRx, Nephron SC, Inc. and Nephron Pharmaceutical Corporation
S-4
10.38
05/21/2021
10.31
Amendment #1 to Manufacturing Supply Agreement, dated as of September 2, 2020, by and among NeuroRx, Nephron SC, Inc. and Nephron Pharmaceutical Corporation
S-4
10.39
05/21/2021
10.32
Amendment #2 to Manufacturing Supply Agreement, dated as of November 5, 2020, by and among NeuroRx, Nephron SC, Inc. and Nephron Pharmaceutical Corporation
S-4
10.40
05/21/2021
10.33
Amendment #3 to Manufacturing Supply Agreement, dated as of February 5, 2021, by and among NeuroRx, Nephron SC, Inc. and Nephron Pharmaceutical Corporation
S-4
10.41
05/21/2021
10.34
Share Subscription Facility Agreement, dated as of October 18, 2019, among NeuroRx, GEM Global Yield LLC SCS and GEM Yield Bahamas Limited
S-4
10.42
05/21/2021
10.35
Common Stock Purchase Warrant dated March 28, 2021
S-4
10.43
05/21/2021
10.36
Clinical Trial Participation Agreement, dated as of December 17, 2020, by and between Quantum Leap Health Care Collaborative and NeuroRx
S-4
10.44
05/21/2021
10.37
Consulting Agreement with Randolph Guggenheimer III
8-K
10.33
05/28/2021
10.38
Voting Agreement by and between Jonathan Javitt and Daniel Javitt
8-K
10.34
05/28/2021
10.39
Statement of Work, dated July 26, 2021, between Pilltracker Ltd. and NeuroRx, Inc.
10-Q
10.1
11/15/2021
10.40
Form of Securities Purchase Agreement, dated as of January 30, 2022, by and among the Company and the Purchasers.
8-K
10.1
02/03/2022
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Incorporated by Reference Exhibit
Exhibit Number
Description
Form
Exhibit
Filing
Date
File
Herewith
10.41
Form of Preferred Investment Options, dated as of February 2, 2022, by and among the Company and the holders.
8-K
10.2
02/03/2022
10.42
Form of Registration Rights Agreement, dated as of January 30, 2022, by and among the Company and the Purchasers.
8-K
10.3
02/03/2022
10.43
Form of Placement Agent Preferred Investment Option, dated as of February 2, 2022 by and among the Company and H.C. Wainwright & Co., LLC.
8-K
10.4
02/03/2022
10.44
Consulting Agreement, dated March 8, 2022, by and between the Company and Dr. Jonathan Javitt
8-K
10.1
03/09/2022
10.45
Letter Agreement, dated March 9, 2022, by and between NeuroRx, Inc. and REBes Consulting LLC – Robert Besthof
8-K
10.2
03/09/2022
10.46
Executive Employment Agreement, dated June 13, 2022, by and between NRx Pharmaceuticals, Inc. and Seth Van Voorhees
10-Q
10.1
08/15/2022
10.47
Share Purchase Agreement, dated November 4, 2022, by and between NRx Pharmaceuticals, Inc. and Streeterville Capital, LLC
8-K
10.1
11/09/2022
10.48
Form of Note, dated November 4, 2022, by and between NRX Pharmaceuticals, Inc. and Streeterville Capital, LLC
8-K
10.2
11/09/2022
10.49
Form of Guarantee, dated November 4, 2022, by and between NeuroRx, Inc. and Streeterville Capital, LLC
8-K
10.3
11/09/2022
10.50
Executive Employment Agreement, dated July 12, 2022, by and between NRx Pharmaceuticals, Inc. and Stephen Willard
10-Q
10.1
11/14/2022
10.51
Share Purchase Agreement, dated March 8, 2023, by and between NRx Pharmaceuticals, Inc. and Purchasers
8-K/A
10.1
03/14/2023
10.52+
Pill Tracker Supplemental Task Order, dated November 15, 2021.
10-K
10.46
03/31/2022
10.53
Amendment to Consulting Agreement, dated March 29, 2023, by and between the Company and Dr. Jonathan Javitt.
X
23.1
Consent of Independent Registered Accounting Firm
X
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1†
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
32.2†
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
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Incorporated by Reference Exhibit
Exhibit Number
Description
Form
Exhibit
Filing
Date
File
Herewith
101
Interactive data files pursuant to Rule 405 of Regulation S-T formatted in Inline XBRL: (i) Consolidated Balance Sheets as of December 31, 2022 and December 31, 2021; (ii) Consolidated Statements of Operations for the years ended December 31, 2022 and 2021; (iii) Consolidated Statements of Changes in Stockholders' Equity (Deficit) for the years ended December 31, 2022 and 2021; (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021; and (v) Notes to Financial Statements
104
Cover Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101)
+ Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulations S-K. The Company will furnish supplementally an unredacted copy of such exhibit to the Securities and Exchange Commission or its staff upon request.
† This certification is being furnished solely to accompany this annual report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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, on March 31, 2023.
NRX PHARMACEUTICALS, INC.
By:
/s/ Seth Van Voorhees
Seth Van Voorhees
Chief Financial Officer (Principal Financial Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on March 31, 2023 by the following persons on behalf of the registrant and in the capacities indicated:
Signature
Title
/s/ Stephen H. Willard
Stephen H. Willard
Chief Executive Officer
(Principal Executive Officer)
/s/ Seth Van Voorhees
Chief Financial Officer
Seth Van Voorhees
(Principal Financial Officer and Principal Accounting Officer)
/s/ Patrick J. Flynn
Director
Patrick J. Flynn
/s/ Sherry A. Glied
Director
Sherry A. Glied
/s/ Aaron Gorovitz
Director
Aaron Gorovitz
/s/ Chaim Hurvitz
Director
Chaim Hurvitz
/s/ Jonathan C. Javitt
Director
Jonathan C. Javitt
132
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.