NRx Pharmaceuticals filed a New Drug Application (NDA) for an intravenous ketamine therapy for suicidal disorder as part of its efforts to expand the network of psychiatric centers, according to a company statement released on Monday.
In addition to its quarterly and annual financial reports, released on Monday, it also announced that the company is working on two important pharmaceutical candidates as part of an overall business strategy aimed at developing a network of mental health clinics.
In a press release, Chairman and CEO Jonathan Javitt stated that “our work during the fourth quarter and beyond 2025 will have driven significant advancements for our company as well as investors.” “These achievements advance our mission to prevent and treat suicide. This work is vital for our patients, families, and country.”
The FDA has approved the manufacturing module for NRX 100, a drug that is marketed as a formulation without preservatives of intravenous ketamine to treat suicidal depressive disorders. A pharmaceutical company, who shall remain nameless, has also offered non-binding conditions to the company for licensing and distributing NRX100. This could result in more than $300,000,000 of milestone payments and tiered, double-digit royalty rates based on sales.
According to the press release, NRx submitted Module 3 (manufacturing), of its NDA, for NRX 100, citing efficacy results from four clinical studies to support the request. Prescription Drug User Fee Act Date (PDUFA). The company expects to have a date before Dec. 31, 2018.
NRx plans to submit a separate NDA, NRX-101, for its second drug, NRX 101, which combines D -cycloserine with lurasidone, for the treatment of bipolar depression among patients who are at high risk for akathisia – a movement disorder that is associated with a suicide risk. This application seeks accelerated approval based on STABIL B and Phase 2b/3 trial results.
In a separate business venture, HOPE Therapeutics’ wholly-owned subsidiary signed nonbinding letters to intent in order to purchase three precision psychiatry centres and is currently negotiating the terms of acquisition for six more centers. The clinics will be used to create a network of interventional psychiatry centers that treat post-traumatic disorder, suicidal depressive disorders and other conditions.
According to HOPE Therapeutics’ business model, national dialysis providers “normally trade with double-digit P/E multiples.” To meet 2025 growth goals, the company plans to acquire 20 clinic networks with an average of $5 million per network in revenue.
NRx has reduced its operating loss by nearly 45%, from $4.4 to $2.4million, for the period ending December 31st 2024. This was primarily due to the lower costs of research and development following the completion of phase 2b/3 for NRX-1001.
NRx reduced its operating loss by $9.3 millions, or approximately 33.5%. This will bring the total year’s losses down to $18.5 from $27.8 for 2023.
The company had around $1.4m in cash and equivalents at the end of last year, but completed two loans in January for an aggregate gross of $8m. The management believes that current cash resources are sufficient to sustain ongoing operations until at least 2025.
The company stated in a press release that “management continues to project, but no guarantees can be made, profitability on an forward-looking, run-rate-based basis by the end of 2025.”
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 will file a new Abbreviated Drug Application in the second quarter of this year for preservative-free Ketamine, across all existing indications. This is supported by a demonstrated production capacity that exceeds one million vials / month.
The company has also regained Nasdaq compliance’s requirement for the market value of listed stocks and engaged BTIG to serve as a financial advisor on clinic acquisition strategies and capital formation.