NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025
The Company has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales
Retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride, a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications
HOPE Therapeutics, a wholly owned subsidiary of NRx, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers
The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions
Received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions.
Engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities
Regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement
Substantially reduced operating costs compared to prior year
Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025
WILMINGTON, Del., March 17, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year ended December 31, 2024, and provided a business update.
"Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it's NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE's best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, and CEO of NRx Pharmaceuticals. "I would like to thank our team for its dedication and hard work, and thank our shareholders for their ongoing support of our mission to bring hope to life."
Key Research and Development and Corporate Activities
NRX-100 (IV, preservative-free ketamine)According to the CDC, more than 13 million adults contemplate suicide each year; NRX-100, IV ketamine for Suicidal Depression - can help address this national crisis.
The Company filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025.
NRX-100 is poised to address the >$3 billion Suicidal Depression market in the US.
The Company has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement.
In December 2024 the company demonstrated long term stability and sterility of a patentable formulation of preservative-free ketamine, despite longstanding commercial practice of adding benzethonium chloride as a preservative to commercially supplied ketamine. This preservative is a known caustic and toxic substance that has previously demonstrated corneal neurotoxicity and conjunctival toxicity in patients, and generalized neurotoxicity in the laboratory at microgram concentrations. The concentration in current ketamine preparations is substantially higher, with an extensive body of scientific literature documenting concern. Additionally, chronic administration of ketamine is known to increase the risk of cystitis ( Ref ); the relationship of this adverse event to benzethonium chloride is unknown. Now that a long-term stable and sterile preservative-free formulation is available, the Company is filing a citizens petition to seek removal of benzethonium chloride from the human and veterinary ketamine drug supply.
The Company believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients and is consistent with evolving federal policy on toxic preservatives in the US food and drug supply chain. Therefore, in addition to ...
