Overview of NRX Pharmaceuticals

NRX Pharmaceuticals is a biopharmaceutical company focused on developing innovative treatments for psychiatric and neurological disorders. The company has two lead compounds - NRX-100, a proprietary form of the drug ketamine, and NRX-101, a combination of two existing medications. Both have been granted Fast Track designation by the FDA for treating suicidal bipolar depression.

The company was founded in 2015 and had to pause its central nervous system drug development in 2020 due to the COVID-19 pandemic. However, it was able to continue operations and attract new funding by working on COVID-19 drug development. In 2022, the company’s board decided to refocus on its original mission of developing treatments for psychiatric disorders.

Financial Performance

For the year ended December 31, 2024, NRX Pharmaceuticals reported a net loss of $25.1 million, compared to a net loss of $30.2 million in 2023. The company’s accumulated deficit has reached $278.3 million as of the end of 2024, and it has a stockholders’ deficit of $23.5 million and a working capital deficit of $18.8 million.

The decrease in net loss from 2023 to 2024 was primarily due to a $7.2 million reduction in research and development expenses, as the company concluded its phase 2 study for NRX-101 and focused on cost-saving measures. General and administrative expenses also decreased by $0.7 million, driven by lower insurance, employee, and patent costs, partially offset by increases in consulting and legal fees.

Liquidity and Financing

NRX Pharmaceuticals has generated no revenue to date and is dependent on obtaining additional financing to fund its ongoing operations and clinical development activities. The company has concluded that substantial doubt exists about its ability to continue as a going concern for at least the next 12 months.

To address its liquidity needs, the company has secured several financing transactions in 2024 and early 2025:

• In August 2024, the company executed a $16.3 million securities purchase agreement to issue convertible notes and warrants. The proceeds were used to settle outstanding debt and for working capital.

• In April 2024, the company raised $2.4 million through a public offering of common stock.

• In February 2024, the company raised $1.7 million through a public offering of common stock and an additional $1 million through a private placement of common stock and warrants.

• In January 2025, the company raised $3.5 million through a registered direct offering of common stock and warrants.

The company is also in negotiations to secure additional capital through a strategic investment and commercial credit facilities to support the expansion of its HOPE Therapeutics subsidiary, which is focused on developing a clinical market for ketamine and other treatments for suicidal depression.

Nasdaq Listing Requirements

NRX Pharmaceuticals has faced some challenges in meeting the Nasdaq listing requirements. In July 2023, the company received a notice that it was not in compliance with the minimum market value of listed securities requirement. The company was granted an initial compliance period until January 2024 to regain compliance.

In October 2023, the company also received a notice regarding non-compliance with the minimum bid price requirement. The company was granted an exception until April 2024 to demonstrate compliance by transferring its listing to the Nasdaq Capital Market. The company was able to regain compliance with the market value requirement in January 2025.

Outlook and Risks

NRX Pharmaceuticals’ future success will depend on its ability to advance its lead drug candidates, NRX-100 and NRX-101, through clinical development and regulatory approval. The company has several key milestones ahead, including:

• Filing module 3 (manufacturing) of its NDA for NRX-100 (preservative-free sterile ketamine) and anticipating a PDUFA date prior to December 30, 2025.
• Initiating clinical testing of its novel pH neutral ketamine formulation, HTX-100, by 2026.
• Continuing the development of NRX-101 for the treatment of complicated urinary tract infections, which has received Qualified Infectious Disease Product, Fast Track, and Priority Review designations from the FDA.

However, the company faces significant risks, including its ability to raise sufficient capital to fund its operations, the potential failure of its drug candidates in clinical trials, and competition from other treatments. The company’s ongoing losses and working capital deficits raise substantial doubt about its ability to continue as a going concern.

Overall, NRX Pharmaceuticals is a clinical-stage biopharmaceutical company with a focus on developing innovative treatments for psychiatric and neurological disorders. While it has faced some financial and operational challenges, the company is working to advance its pipeline and secure the necessary funding to continue its operations and pursue its strategic objectives.