NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical firm focused on developing innovative therapies for disorders of the central nervous system and critical ...
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company headquartered in Wilmington, Delaware, founded in 2015. The company is dedicated to addressing high unmet medical needs in central nervous system (CNS) disorders and critical care. Its lead product candidate, ZYESAMI (aviptadil), is an investigational therapy that has completed Phase ...NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company headquartered in Wilmington, Delaware, founded in 2015. The company is dedicated to addressing high unmet medical needs in central nervous system (CNS) disorders and critical care. Its lead product candidate, ZYESAMI (aviptadil), is an investigational therapy that has completed Phase IIb/III clinical trials for the treatment of respiratory failure associated with COVID-19. Additionally, NRx is advancing a portfolio of oral therapeutics, including NRX-100 (ketamine) and NRX-101 (a combination of D-cycloserine and lurasidone), designed to treat bipolar depression, particularly in patients with acute or sub-acute suicidal ideation and behavior. The company also explores treatments for chronic pain and PTSD. Founded by Dr. Jonathan C. Javitt, who serves as Founder, Chairman, and CEO, NRx draws on decades of expertise in drug development and healthcare technology. The company's proprietary NMDA platform targets glutamatergic pathways, offering a novel approach to mood and cognitive disorders. With a small team of approximately 29 employees, NRx is strategically focused on clinical development and regulatory milestones. Financially, the company is in a pre-revenue stage, with negative operating cash flows and a market capitalization of around $58.8 million as of the latest data. Despite challenges, NRx continues to advance its pipeline, leveraging scientific innovation to bring hope to patients with life-threatening conditions.
Operator: Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Second Quarter 2026 Results Conference Call. . I would now like to turn the conference call over to Sebastian Gomez of astr partners. Please go ahead. Sebastian Gomez Alarcon Thank you, operator, and welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued today and in the company's Form 10-Q, which may be accessed from the Investor page of the NRx Pharmaceuticals website. Joining me on today's call is Dr. Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of the company's progress during both the first half of the year and second quarter in particular, following which Michael Abrams will review our financial results. Following their prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan?
Jonathan Javitt: Thank you, Sebastian. Good morning, everyone. Thank you for joining us. The second quarter of 2026, was a major inflection point for our company across multiple key objectives as we advanced our mission to bring hope to valuable patients battling depression and suicidal ideation. We continue to drive forward toward those key objectives with quarterly results that include completing the first cycle of a review of our ANDA for preservative-free ketamine with only a single remaining major deficiency to resolve with FDA, advancing the path to approval for NRX-100, supported by White House and Congress guidance to the FDA for the use of real-world evidence to establish comparable or superior efficacy working in concert with the U.S. military as the prime contractor that's been identified for the SPARC-TMS trial. That's an FDA-approved Phase II/III trial of NRX-101 with robotic TMS that we expect will include 240 patients in our HOPE clinics and at Harvard/McLean together with another 160 patients at military treatment facilities all funded through the military. And we're still in the contracting process for that. Completing the acquisition of the general assets and the resulting partnership with NIH, to potentially develop the first disease-modifying drug to treat ALS and finally, continuing growth and development …