RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) recently shared its financials and offered updates on its business operations from the first quarter of 2024. On the financial front, the pharmaceutical company has finalized a term sheet with a reputable institutional investor to clear current debts with a $7.5 million note. This key move is expected to pave the way for a share distribution of Hope Therapeutics, and an additional provision for further funding of up to $30 million to enrich their pipeline opportunities.
In a significant development, a Phase 2b/3 trial of NRX-101, aimed at addressing Treatment Resistant Bipolar Depression, reported positive data. The trial demonstrated that the drug was as effective as the current standard treatment for depression, and notably reduced akathisia – a potentially fatal side effect usually associated with antidepressants serotonin-targeted. Akathisia has been known to increase the risk of suicide.
Notably, the trial displayed a 30% advantage in sustained remission from suicidality. Even though this particular advantage wasn’t statistically significant at the provided sample size, it does reflect the results of NRX’s previous STABIL-B trial and an independent trial.
The company has plans to request Accelerated Approval under Breakthrough Therapy and Priority Review for NRX-101. This is based on the aforementioned trial and the STABIL-B trial. Also in development is a pH-neutral formulation for ketamine, a drug that can be administered intravenously and subcutaneously, with manufacturing plans in motion ahead of the intended New Drug Application (NDA) initiation in July.
NRX is also making strides in the care delivery sector. Ahead of FDA approval, their division, Hope Therapeutics, is aiming to address the national ketamine shortage. Hope has teamed up with ketamine clinic providers across the country to build a comprehensive care platform that includes ketamine, digital therapeutic extensions, and operational support.
Further, a Department of Defense-funded trial is set to release data on NRX-101’s ability to treat chronic pain. Additionally, the drug is under review for the treatment of Complicated Urinary Tract Infection, for which it received Qualified Infectious Disease Product, Fast Track, and Priority Review designations.
The company ended the first quarter of 2024 with $1.3 million in cash and cash equivalents, not counting the $5.1 million of working capital promised by Alvogen. This included a $2.2 million debt reduction to Streeterville LLC. Over the first three months of 2024, the company improved access to $8 million in total working capital, which included $2.9 million from equity sales and $5.1 million from the Alvogen milestone advance.
The latest strides by NRx reflect a strong commitment to operational efficiencies and a focus on revenue generation. These developments are likely to create value for its shareholders and contribute to medical breakthroughs in areas with unmet needs.
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