NRX Pharmaceuticals, Inc.

Good day and welcome to the NRX Pharmaceutical second quarter 2022 on-year conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Start and 1 on your touchtone phone. To redraw your question, please press Start in 2. Please note, this event is being recorded. I would now like to bring the conference over to Tom Johnson. Please go ahead.

Thank you, operator. 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. and 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 the date hereof, and the company undertakes no obligation to update or revise these forward-looking statements. Information presented on this call is contained in the press release issued earlier today and in the company's Form 10-Q that we're filing today, which may be accessed from the investors' page of the InterX Pharmaceuticals, Inc. website. Joining me on today's calls from InterX Pharmaceuticals are Stephen Willard, Chief Executive Officer, and Seth Van Voorhees, Chief Financial Officer and Treasurer. Stephen will provide a summary of the company's progress before turning it over to Seth for a review of the financial results. Following their prepared remarks, Stephen and Seth will be joined by Robert Bestoff, Head of Operations and Chief Commercial Officer, to address investor questions. I will now turn the call over to Stephen.

Thank you, Tom. Good morning, everyone, and thank you for joining us today. I'm excited to host my first quarterly results call as CEO of NRX Pharmaceuticals. I've spent a large portion of my career in both private industry and public service dedicated to advancing compelling science to benefit people and to build value for shareholders. When I decided to assume the leadership role of NRX, I saw an opportunity to do both. Joining me in this endeavor are Seth Van Voorhis, our new Chief Financial Officer, Jonathan Javid, our Chief Scientific Officer, and Robert Bestoff, Head of Operations and Chief Commercial Officer. We appreciate your attendance today and look forward to engaging with you on this and future calls as we work to realize the opportunities before us. Before discussing our second quarter results and plans for the balance of this year, I wanted to take a few moments to highlight what attracted me to the opportunities of NRX. First, NRX has an extraordinary organization with a strong scientific and regulatory foundation and a unique and robust intellectual property portfolio. This fact is a point of differentiation between NRX and many of its competitors. Second, our lead asset, NRX 101, forms the basis of a psychiatry franchise with potential applications in the array of mental health issues such as PTSD and other major depressive disorders. And third, our renewed development program for NRX 101 seeks to address significant unmet medical needs in bipolar depression that also represent a significant commercial opportunity. Together with a strong team that has a track record of rapidly developing and bringing life-saving medications to market, I am delighted to be leading the effort to change the treatment paradigm for those patients and deliver value to all of us. So let's begin. NRX 101. To our knowledge, NRX 101 is the only oral antidepressant that targets patients with bipolar depression and active suicidality, which typically is an exclusion criteria in clinical studies of depression and PTSD. Data from one of our previously completed Phase II clinical trials shows a significant reduction in both depression and suicidality compared to standard therapy in patients with bipolar depression who were acutely suicidal and who were initially stabilized with ketamine. We have also released preclinical findings demonstrating that, unlike ketamine, the key component in NRX101 is not addictive. Moreover, we have shared with you the peer-reviewed biomarker findings from Columbia University showing that NRX-101 achieves the same chemical changes in the brain as are achieved by ketamine, and that these changes are statistically correlated with improvement in depression. NRX-101 is the only psychiatry drug that has been granted the biomarker letter by FDA, which you may read on the FDA website. The potential oral, non-addictive nature of NRX 101 therapy, combined with its potential therapeutic effects to reduce both depression and suicidality, offers significant advantages over other commercial and developmental drugs as a new therapeutic option for bipolar patients. During our second quarter, we met our stated milestones for advancing NRX 101 to commercialization. Let me share the catalysts we project for the rest of the year. We initiated enrollment in our new phase two trial of NRX 101 patients and patients who have bipolar depression with subacute suicidal ideation and behavior and have activated 10 clinical sites, which represents about two-thirds of our intended sites. Additional sites are being activated soon and enrollment is ongoing. This 70-patient study is targeted at patients with bipolar depression and suicidality that do not require hospitalization. We expect to upgrade this trial to a Phase III as soon as we release our newly manufactured Phase III drug supply and have received FDA's guidance on primary and secondary endpoints. This trial in subacute patients who were treated in the outpatient setting aims to achieve a substantial enlargement of our potential indication from the 150,000 to 180,000 patients with bipolar depression and acute suicidality to the significantly larger population of patients being treated in the ambulatory setting. As I mentioned at the annual meeting of shareholders, we view this as a $2 billion opportunity. The subacute trial also reflects the request of many of our study clinicians who voiced the desire to also treat patients who were on the verge of needing to be hospitalized due to their increased thoughts of suicides. NRX-101 is the first drug introduced for these patients that has shown potential to decrease, rather than increase, risk of suicide, unlike SSRI antidepressants, and perhaps even reduce the need for hospitalizations. We project a readout of the data of this trial by the end of 2022 or in the first quarter of 2023, and look forward to adding it to our registration package. During the second quarter, we also advanced preparations to restart our Phase III trial of NRX-101 in patients with acute suicidal ideation and behavior under a special protocol agreement awarded to us by FDA. This study will be conducted with commercial-level material and, if successful, could lead to a new drug application, or NDA, with the FDA for NRX-101 by late 2023 or the first half of 2024. Recall that as part of our special protocol agreement with the FDA, the agency advised us in writing that successful completion of this trial would permit a regulatory filing for drug approval. Conducting this trial with commercial-level material is key to submitting clinical data on a rolling basis under our breakthrough designation by, as I said, mid-2023, a potential NDA filing by year-end 2023, and commercialization as early as 2024. During the first half of 2022, we transferred manufacturers NRX 101 to Alchemy Corporation in North Carolina in order to enable phase three readiness and preparedness for commercial stage. We have recently manufactured our first batch of medicine. Manufacturing is a crucial element to achieving submission readiness and approval for a new drug. This investment is an important piece of our overall plan to initiate our Phase 2B-3 registrational study with commercial-level materials. The psychiatry franchise is the starting foundation of our company, and with our broad patent estate, we believe we are in a unique position to deliver a highly differentiated product to help patients in this area of very high unmet medical needs. We are also considering exploring other high unmet medical need indications, such as PTSD with suicidality. There are approximately 9 million individuals in our country that experience PTSD. One-third of them have severe PTSD. Between 17 and 22 members of our armed forces of veterans are lost every day to suicide. We view this as another very high unmet medical need. Our intellectual property estate offers a range of options to combine a variety of molecules and NMDA receptor antagonists, including D-cycloserine, a component of NRX-101. Turning to Zysami, as we announced in May, the NIH ACTIVS-3B TASICO trial was stopped for futility. COVID-19 continues to be an unpredictable and challenging area. as evidenced by another clinical trial done recently for another company by the NIH that also did not read out with the desired efficacy. Our assessment of future options for Zysami will be guided by independent analysis of the NIH data, along with data we received from an independent assessment of chest X-rays from a sub-study that includes a subgroup of approximately 80 patients that had survived to day 10 during our phase 2B-3 study. This sub-study showed a statistically significant improvement in chest x-rays using real scores in patients with COVID-19 respiratory failure compared to a worsening in patients treated with placebo, and that P was less than 0.05. We expect to receive the NIH data in the late third quarter or early fourth quarter, and we'll conduct an independent analysis at this time. Earlier this year, we completed manufacture of Phase 3 commercial-ready Zazami. We are not funding additional trials of Zazami at this time. With that, I will turn it over to Seth for a brief overview of our financial results. Seth?