NRX Pharmaceuticals, Inc.

Good day and welcome to the NRX Pharmaceuticals Incorporated second quarter 2023 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Matthew Duffy, the company's chief business officer. Please go ahead, sir.

Thank you, Chuck. 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 security laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from the historical experience or present our 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 to hear of, and the company undertakes no obligation to update and revise the forward-looking statements. Information presented on this call is contained in the press release issued earlier today and in the company's form TED-Q filed today. which may be accessed from the investor page of the NRX Pharmaceuticals Incorporated website. Joining me on the call are Stephen Willard, our Chief Executive Officer, Jonathan Javik, our Chief Scientist, and Seth VanBoordies, our Chief Financial Officer and Treasurer. Stephen and Jonathan will provide a summary of the company's progress. Seth will review the company's financial results. And then Stephen will review upcoming milestones before making closing comments. Following their prepared remarks, we will have to address investor questions. I'll now turn the call over to Sita.

Thank you, Matt. Good afternoon, everyone, and thank you for joining us. Our second quarter reflects an important inflection point for the company as we advance our novel NMDA platform. This expansion of our pipeline is driven by our signed partnership agreement with Alvagen and Lotus Pharmaceuticals related to the use of NRX 101 our breakthrough investigational medicine in bipolar depression with suicidality. The milestones and commitments within that partnership, as disclosed in our filings and described in the press release, provide the extensive financial resources needed to fund Phase III and commercialization of NRX 101 in the syndication without additional dilution to our shareholders should we deliver a statistically significant data readout. When we met with FDA last January, and FDA guided us to broaden our clinical indication and to develop a 1500 person safety database, investors asked how we were going to fund this program. The Alvagen deal answers this question. In our previous calls, we've explained the urgent unmet need for a medicine to treat this group of patients who have a 50% lifetime risk of suicide attempt and who have been excluded from trials of all previous antidepressants. The urgent need is detailed on our website and validated by FDA's award of breakthrough therapy designation and a special protocol agreement. As further validation of the life-saving implications of this therapy, this week we published the previously announced results of STABLE-B in the International Journal of Pipolar Disorders. a peer-reviewed, high-impact journal published by Springer Nature. The lead author is Professor Andrew Nirenberg, who leads bipolar research at Harvard Mass General Hospital. The article documents a nearly eight-point difference on the Madras depression scale when NRX is tested against lorazodone, a difference approximately two-fold greater than the difference seen when typical antidepressants are tested against placebo. Moreover, to our knowledge, this is the first oral drug to demonstrate a statistically significant reduction in suicidality, a benefit seen only previously with IV ketamine. Now we are engaged in a Phase IIb-3 trial that seeks to document the benefits of NRX-101 in suicidal patients without prior IV ketamine. We have formed a joint steering committee with our partner. Our scientific and management teams are now working regularly in partnership with teams from Alvagen and Lotus in order to collaboratively bring a lifesaving drug to market. I am pleased to announce that our clinical trial is now within 20 patients of an anticipated data readout. We are now establishing a broad base of study sites in anticipation of a substantially larger phase three initiative funded by our partner. More importantly, we are seeing promising indications of quality with 90% medication compliance and 94% concurrence of depression scores measured at the study site with the scores measured by our central master psychometric raters. Dr. Javitt will provide some insights into the quality metrics we are observing. The Alvagen partnership affords us an opportunity to explore new and broader indications for NRX 101. Because we completed our phase three commercial manufacturing program in Q1, we are able to seamlessly introduce these indications to FDA and have more than one million doses of medicine in the warehouse with which to initiate new programs. Specifically, we are exploring the use of NRX-101 in chronic pain and post-traumatic stress disorder. Jonathan, would you review the science results achieved during Q2 and reflect on our near-term goals?