NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced its progress towards filing New Drug Applications (NDAs) for two key drug candidates, NRX-100 (IV Ketamine) and NRX-101 (Oral D-Cycloserine/Lurasidone), aimed at treating suicidal ideation in depression, including bipolar depression. The company anticipates filing these NDAs by the end of 2024, with a potential PDUFA date forecast in 2025. This announcement coincides with the report of the company's financial results for the third quarter and year-to-date 2024, showcasing a significant reduction in net operating losses.
Clinical Advancements of NRX-100 and NRX-101
NRx Pharmaceuticals is leveraging data from multiple clinical trials involving over 500 patients to support the NDA filing for NRX-100. These trials, conducted in collaboration with leading US and French Universities, have demonstrated a highly significant reduction in suicidal ideation compared to placebo and active comparators. Notably, post-hoc analysis suggests that IV ketamine may be superior to electroshock therapy in treating depression. The company has completed stability and toxicology data requirements and has aligned with the FDA on its Pediatric Study Plan.
NRX-101's NDA for accelerated approval is based on data from a Phase 2b/3 trial in suicidal patients with bipolar depression. The trial demonstrated depression efficacy comparable to the standard of care, along with a significant reduction in akathisia (P=0.025) and time to sustained remission from suicidality (P=0.05). These findings, combined with data from the STABIL-B trial, suggest a potential best-in-class profile for treating suicidal bipolar depression, addressing a multi-billion-dollar market in the US.
HOPE Therapeutics Expansion
HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals, is actively building a network of Interventional Psychiatry Clinics. The company has signed two Letters of Intent (LOI) to acquire foundational clinics, aiming to create a best-in-class network offering a range of therapies for patients with suicidal depression and PTSD. HOPE Therapeutics anticipates generating its first revenue by the end of 2024 and forecasts corporate profitability in 2025.
Financial Highlights and Upcoming Milestones
NRx Pharmaceuticals has secured $10.8 million in convertible-debt funding from an institutional investor to support the FDA New Drug Applications for NRX-100 and NRX-101 and to retire prior debt. The company has also retired Streeterville debt and settled litigation at a substantial discount.
Key milestones for the remainder of 2024 include the NDA filing for NRX-100 for the treatment of suicidal ideation in depression, including bipolar depression, and the NDA filing for accelerated approval of NRX-101 for the treatment of bipolar depression in patients with akathisia or suicidality.
Management Commentary
"Our work in recent months has set the stage for major advances in our business. Moving forward on new drug applications for NRX-100 and NRX-101, along with building HOPE's best-in-class network of Interventional Psychiatry Clinics, significantly advances our mission of preventing and treating suicide. This is vital for patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, CEO and Chief Scientist of NRx Pharmaceuticals.
Third Quarter Financial Performance
For the three months ended September 30, 2024, NRx Pharmaceuticals reduced its operating net loss from $6.1 million in the third quarter of 2023 to $1.6 million in 2024, representing nearly a 75% improvement year over year. Research and development expenses decreased from $3.3 million in 2023 to $0.6 million in 2024. As of September 30, 2024, the company had $1.6 million in cash and cash equivalents, with subsequent financing expected to support the NDA filings and general corporate purposes.
