RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has released its financial results for the second quarter and year-to-date ending June 30, 2024, along with a comprehensive business update. The company reported significant advancements in its financial health, strategic initiatives, and future plans, particularly focusing on New Drug Applications (NDAs) for NRX-100 and NRX-101.
Financial Performance
For the quarter ending June 30, 2024, NRx reduced its net loss to $7.9 million, nearly a 10% improvement from the $8.7 million net loss in the second quarter of 2023. Research and development (R&D) expenses also saw a decline, from $3.9 million in 2023 to $2.8 million in 2024. This decrease was primarily due to a reduction in clinical trial and development expenses, offset by increased costs related to Alvogen warrants.
For the six months ended June 30, 2024, the company reported a net loss reduction to $14.4 million compared to $19.8 million in the previous year. This represents an improvement in net loss per share by $1.32 or 47% year over year. R&D expenses for the same period decreased by 39%, from $7.5 million in 2023 to $4.6 million in 2024.
General and administrative (G&A) expenses also saw a reduction, from $9.9 million in the first half of 2023 to $8.5 million in 2024, marking a nearly 15% decrease. As of June 30, 2024, the company had $1.9 million in cash and cash equivalents.
Strategic Initiatives and Future Plans
NRx has been focused on securing funding to support its NDA filings for NRX-100 (ketamine) and NRX-101. The company successfully executed a convertible debt instrument with Anson Funds of Toronto, securing $10.8 – $16.3 million. This funding is intended to retire existing debt and support FDA filings for NRX-100 and NRX-101 in the fourth quarter of 2024. The new funding terms are more favorable compared to prior debt, eliminating provisions for “extraordinary redemptions.”
Concurrent with the Anson investment, NRx settled its litigation with Streeterville Capital, LLC at a substantial discount to the claimed amounts, further improving its financial health.
Progress on NRX-100 and NRX-101
The company is making significant strides with NRX-100, an intravenous ketamine treatment for suicidal depression. Data from four clinical trials involving nearly 1,000 participants have demonstrated highly significant efficacy compared to placebo, active comparators, and electroshock therapy. The company plans to file an NDA for NRX-100 once stability data on three manufacturing lots are fully matured. Additionally, the company has aligned with the FDA on its Pediatric Study Plan for NRX-100, a critical step for the NDA filing.
NRX-101, aimed at treating suicidal bipolar depression, has also shown promise. Data from a Phase 2b/3 trial demonstrated significant improvements in safety and efficacy, including a reduction in akathisia and time to sustained remission from suicidality. The company plans to file an NDA for Accelerated Approval under the Breakthrough Therapy Designation and Priority Review for NRX-101 later this year.
HOPE Therapeutics Spinout
NRx is also progressing with the spinout of HOPE Therapeutics, its wholly-owned subsidiary focused on developing a network of clinics offering advanced psychiatric treatments, including ketamine therapy for suicidal depression. HOPE is planned to be spun out as a separate company owned by NRx, its shareholders, and new investors. The spinout aims to strengthen NRx’s balance sheet and enhance shareholder value.
Appointment of Dr. Dennis McBride
In a significant addition to its leadership, NRx appointed Dr. Dennis McBride, a veteran in neuroscience, information technology, and medical technology, to its Board of Directors. His expertise is expected to contribute to the company’s strategic initiatives and future growth.
CEO’s Statement
“NRx has continued to execute on our plans to file two NDA’s this year. As we near maturation of NRX-100 stability data, we also achieved an important milestone in aligning with the FDA on our pediatric study plan. Together with strong clinical data from four clinical trials, we believe this application will be quite robust. Additionally, the important data generated from two trials conducted by NRx with NRX-101 in suicidal bipolar depression sets the stage for a second NDA for Accelerated Approval later this year. Finally, work continues to spin out Hope Therapeutics and distribute shares to NRx stockholders. We believe reaching these important milestones will generate significant value in the company and reward our shareholders,” said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. “Facilitated by funding to allow us to achieve these goals and while replacing the prior expensive and toxic debt on our balance sheet, we are in a position to deliver therapy that can meet considerable unmet medical need in millions of patients across the country. We are dedicated to bringing hope to life and I thank our team and shareholders for their ongoing hard work and support.”
Conclusion
NRx Pharmaceuticals is making significant strides in both its financial performance and strategic initiatives. With strong clinical data supporting its NDA filings for NRX-100 and NRX-101, the spinout of HOPE Therapeutics, and new leadership, the company is well-positioned for future growth and success.
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