NRx Pharmaceuticals (NASDAQ: NRXP) filed a New Drug Application for its intravenous ketamine treatment for suicidal depression as it tries to expand its psychiatric clinic network, the company said Monday.
The company, which focuses on treatments for central nervous system disorders including suicidal depression and post-traumatic stress disorder, also released its fourth-quarter and full year 2024 financial results on Monday, in which it said it is pursuing two key pharmaceutical candidates alongside a broader business strategy to develop a chain of specialized mental health clinics.
“Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors,” Chairman and CEO Jonathan Javitt said in a statement “These accomplishments advance our mission of preventing and treating suicide, work that is critical to our patients, their families and our country.”
The company’s lead drug candidate, NRX-100, labeled as a preservative-free formulation of intravenous ketamine for treating suicidal depression, completed its manufacturing module filing with the FDA. The company also accepted non-binding terms from an unnamed pharmaceutical company to license and distribute NRX-100, which could provide more than $300 million in milestone payments plus tiered double-digit royalties based on sales, subject to due diligence and a final agreement.
According to the release, NRx filed Module 3 (manufacturing) of its NDA for NRX-100, citing efficacy data from four clinical trials to support the application. The company anticipates a Prescription Drug User Fee Act (PDUFA) date prior to Dec. 31.
NRx also plans to file a separate NDA for its second drug candidate, NRX-101, which combines D-cycloserine and lurasidone for treating bipolar depression in patients at risk of akathisia, a movement disorder associated with suicide risk. That application will seek accelerated approval under breakthrough designation and priority review based on Phase 2b/3 and STABIL-B trial data.
In a parallel business initiative, the company’s wholly owned subsidiary, HOPE Therapeutics, signed non-binding letters of intent to acquire three precision psychiatry centers and is negotiating terms for the acquisition of six additional centers. The company plans to use the clinics to form what the company described as a “national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder and related conditions.”
The business model for HOPE Therapeutics, according to the company, is similar to that of national dialysis providers, which “routinely trade at double digit P/E multiples.” The company is targeting the acquisition of 20 clinic networks, each with approximately $5 million in current revenue, to meet its 2025 growth targets.
For the three months ending Dec. 31, 2024, NRx reduced its loss from operations by $2 million to $2.4 million, down from the $4.4 million loss from operations in the fourth quarter of 2023, a nearly 45% improvement. The company primarily attributed this to lower research and development costs following the conclusion of the phase 2b/3 study for NRX-101.
For the full year, NRx cut its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million from $27.8 million for 2023.
The company reported around $1.4 million in cash and cash equivalents by the end of December, but noted it completed two financings in January with aggregate gross proceeds of $8.5 million. Management stated it believes current available cash resources will be sufficient to support ongoing operations through at least the end of 2025.
“Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025,” the company said in its release.
NRx also mentioned a planned citizen’s petition with the FDA to remove benzethonium chloride – described as a toxic preservative – from presentations of ketamine intended for intravenous use. The company plans a second-quarter filing of an Abbreviated New Drug Application for preservative-free ketamine in all current indications, supported by demonstrated manufacturing capacity exceeding one million vials per month.
The company also regained compliance with Nasdaq’s market value of listed securities requirement and has engaged BTIG as financial advisor for clinic acquisition and capital formation strategies.
[[{“value”:”NRx is pushing its NMDA platform while building a national network of psychiatric treatment centers.
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