NRX Pharmaceuticals Terminates Material Agreement

TL;DR

NRX Pharma terminated a big deal, filing on 6/27.

AI Summary

NRX Pharmaceuticals, Inc. announced the termination of a material definitive agreement on June 21, 2024. The company also reported other events on the same date. This filing was made on June 27, 2024.

Why It Matters

The termination of a material definitive agreement can significantly impact a company's strategic direction and financial obligations.

Risk Assessment

Risk Level: medium — Termination of material agreements can introduce uncertainty and potential financial repercussions for the company.

Key Players & Entities

• NRX Pharmaceuticals, Inc. (company) — Registrant
• June 21, 2024 (date) — Date of earliest event reported
• June 27, 2024 (date) — Date of report
• Big Rock Partners Acquisition Corp. (company) — Former company name

FAQ

Key Financial Figures

• $0.001 — h registered Common Stock, par value $0.001 per share NRXP The Nasdaq Stock Mar
• $113,405 — ion with the exploitation of NRX-101 is $113,405 plus an additional $4,389,300, represen
• $4,389,300 — NRX-101 is $113,405 plus an additional $4,389,300, representing reimbursement of an advan
• $3.7 billion — ket research estimates at approximately $3.7 billion annually, not including the market for

Filing Documents

• tm2418373d1_8k.htm (8-K) — 33KB
• 0001104659-24-075722.txt ( ) — 249KB
• nrxp-20240621.xsd (EX-101.SCH) — 3KB
• nrxp-20240621_def.xml (EX-101.DEF) — 26KB
• nrxp-20240621_lab.xml (EX-101.LAB) — 36KB
• nrxp-20240621_pre.xml (EX-101.PRE) — 25KB
• tm2418373d1_8k_htm.xml (XML) — 5KB

02

Item 1.02 Termination of a Material Definitive Agreement. On June 21, 2024, NRx Pharmaceuticals, Inc. (the " Company " received a notice of termination of Exclusive, Global – Development, Supply, Marketing & License Agreement, dated as of June 2, 2023, as amended dated February 7, 2024 (" Amendment "), by and between the Company, Alvogen, Inc., Alvogen Pharma US, Inc. and Lotus Pharmaceutical Co. Ltd (collectively, " Alvogen ") (together with the Amendment, the " Agreement "), effective immediately. The Agreement provided for the joint development, supply, marketing, commercialization and license to Alvogen of NRX-101. NRX-101 is an FDA-designated investigational breakthrough therapy for suicidal treatment-resistant bipolar depression and chronic pain. The Company partnered with Alvogen around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. Under the terms of the Agreement, the Company and Alvogen will, in good faith, discuss, negotiate and seek to agree to a royalty amount due Alvogen by the Company within the next thirty (30) days. In its notice of termination, Alvogen states that the amounts incurred by or on behalf of Alvogen and its affiliates in connection with the exploitation of NRX-101 is $113,405 plus an additional $4,389,300, representing reimbursement of an advance milestone payment paid to the Company by Alvogen in February 2024 in connection with the Amendment, and reimbursable costs under the Agreement (" Advanced Amounts "). The Advanced Amounts represent, in addition to other reimbursable amounts, amounts paid by Alvogen to the Company's service providers that performed services with respect to the Company's development of NRX-101. Alvogen's termination of the Agreement resulted from Alvogen's perspective that broad approval of NRX-101 would require clinical trials enrolling 500 or more patients, an investment that Alvogen is not currently prepared to undertake. The Company's perspective, informed by

01 Other Events

Item 8.01 Other Events. See

Forward-Looking Statements

Forward-Looking Statements this Current Report on Form 8-K regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the need for additional financing; estimates of the reimbursable expenses resulting from the termination of the Agreement; expectations concerning the termination of the Agreement; the addressable market for the Company's product candidates, including NRX-100 and NRX 101, the Company's ability to attract and/or retain new and existing collaborators with development, regulatory, manufacturing and commercialization expertise and its expectations regarding the potential benefits to be derived from such collaborations; expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's product candidates; and the Company's plans and strategy with respect to developing its product candidates, including NRX-100 and NRX 101. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the actual timing of the transition of responsibilities and activities under the Agreement and the parties' ability to successfully negotiate a royalty amount due Alvogen by the C

SIGNATURES

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: June 27, 2024 By: /s/ Jonathan Javitt Name: Jonathan Javitt Title: Chairman of the Board of Directors

View Full Filing

View this 8-K filing on SEC EDGAR