NRX Pharmaceuticals, Inc.

Good morning and welcome to the NRX Pharmaceuticals Third Quarter 2022 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by a hey-row. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. 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 Suzanne Massari with CERN Investor Relations. Please go ahead.

Thank you, Andrea. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under the U.S. Federal Securities Law. These statements are subject to risk 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 earlier today and in the company's Form 10Q being filed today as well, which may be accessed from the investor page on the NRX Pharmaceuticals website. Joining me on today's call from NRX 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. Seth will review the company's financial results. And then Stephen will review upcoming milestones before making closing comments and opening up for questions. During the Q&A session, Stephen and Seth will be joined by Robert Bestow, Head of Operations and Chief Commercial Officer, and Jonathan Javits, the company's Chief Scientific Officer, to address investor questions. I will now turn the call over to Stephen.

Thank you, Suzanne. Good morning, everyone, and thank you for joining us. Today, we will discuss the third quarter results for our company and provide a business update. In March, we announced that our primary strategic focus going forward is on our psychiatry franchise and the late stage development of NRX 101, our lead investigational compound. Today, we estimate the US annual peak sales potential for bipolar depression with suicidality to be around $2 billion. there are only five drugs currently approved for bipolar depression, none of which is indicated for patients with suicidality. In fact, such patients were excluded from their clinical trials. Our Phase II study specifically enrolled patients with high levels of suicide risk and showed that NRX-101 has the potential to provide improved clinical outcomes in such patients whose only currently approved therapeutical alternative is electroshock therapy. That is why the FDA gave us breakthrough therapy designation and a special protocol agreement allowing for registrational study with 72 patients. In recent months, we have made substantial progress in advancing our development of NRX-101 for the treatment of bipolar depression with suicidality and PTSD, while also exploring other psychiatric indications. In March, we announced the strategic decision to initiate our phase three trial following the release of NRX-101 using processes suitable for ultimate commercial sale of our medicine should we demonstrate safety and efficacy. That milestone was completed and announced last week. Thus, we anticipate initiating our phase three trial under the FDA special protocol agreement in 72 patients as pre-specified with the FDA by the end of this year. We expect to report top line data in the second half of 2023 with initiation of a potential NDA submission by year end 2023, assuming efficacy and safety has been met. Last week, we also announced a debt financing that we project provides us with adequate capital to support this phase three program. NRX-101 is a fixed-dose combination of d-cycloserine, an MMDA receptor modulator, and lorazodone, a drug commonly used for bipolar depression. To our knowledge, NRX-101 is the only oral antidepressant, either approved or in development, that targets patients with bipolar depression and active suicidality, which typically is an exclusion criteria in clinical studies of depression and PTSD. The tragic reality of bipolar depression is that if you know two people with this condition, the odds are that one will attempt suicide. And if you know five people with this condition, the odds are that one will die from suicide. Our phase two and non-clinical evidence suggests that NRX 101 may achieve many of the therapeutic benefits seen with ketamine, which is increasingly used to treat patients with depression and suicidality. Ketamine is known to induce hallucinations. Ketamine is also well known to be neurotoxic and shown to kill brain cells in both animal models and in human clinical reports. FDA has issued warnings about repeated use of ketamine in anesthesia for this reason. We have demonstrated that the ingredients of NRX-101 have not shown potential for neurotoxicity, even at 10 times the expected dose. we have released preclinical findings demonstrating that, unlike ketamine, the NMDA component in NRX101 is non-addictive. Our stable B phase two proof of concept study showed a statistically 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. To our knowledge, no oral drug therapy has ever been able to demonstrate a reduction in both depression and suicidal tendencies in this patient population. This is clinically relevant because antidepressants carry black box warning labels regarding potential for increased risk of suicide in vulnerable populations. Based on NRX 101's differentiated therapeutic profile, we believe that we have the potential to address a significant unmet medical need for patients who are currently underserved by available treatment options. Please see our press release today, issued earlier, for our NRX 101 clinical and regulatory milestones achieved to date. These previous milestones established a strong foundation that enabled us to embark on a highly efficient Registrational Phase III program with FDA's advanced commitment to accept regulatory findings from us should we successfully determine safety and efficacy and demonstrate the two. This foundation also allows us to significantly expand the addressable population of patients with bipolar depression and subacute suicidality to patients who are treated in an outpatient setting and to those with PTSD. Now I would like to cover some of our achievements from the third quarter. We are on track to report top-line clinical data for our ongoing Phase II clinical trial of NRX101 in patients with bipolar depression and subacute suicidal ideation in the first quarter of 2023. The objective of the double-blind study is to demonstrate NRX101's ability to significantly improve both depression and suicidality over six weeks when taken twice daily. The study involves patients with bipolar depression and subacute suicidality and does not require the use of ketamine. As mentioned previously, this is one of the studies that could enable us to expand the potential indication for NRX-101, as well as offer a more convenient treatment option on an outpatient setting. We are also on track with plans to initiate a registrational Phase III clinical trial of NRX-101 by year-end, in patients with severe bipolar depression and acute suicidal ideation. This trial will be randomized double-blind trial of NRX-101 versus lorazodone alone in 72 patients. We expect to confirm our Phase II findings that following a successful response to a single infusion of ketamine, treatment with NRX-101 will be superior to lorazodone, the current standard of care in the patient population. We will do this by showing improvement in symptoms of depression as measured by the Montgomery Asperger Depression Rating Scale. Because of the acute nature of these patients, we agreed with the FDA to compare our drug to lorazodone, a standard of care medication, rather than to placebo. If successful, this would provide clear commercial differentiation. In September, we announced plans for an additional indication in PTSD. Approximately 9 million individuals in our country experienced PTSD, one-third of whom had severe PTSD. Between 17 and 22 members of our armed forces of veterans are lost every day to suicide. We view this as another area of very high unmet medical needs. We expect that our medicine will show antidepressant effects in PTSD. However, we are also hopeful that our medicine will demonstrate specific effects on the fear memory components of PTSD and directly reduce symptoms of PTSD beyond depression. Today, there is no approved medicine for these specific PTSD symptoms, and our preclinical studies have shown a reduction in fear memory associated with T-cyclic series. As announced last week, we submitted our expected commercial stage manufacturing process to the FDA so that we can include this drug product in our upcoming registrational phase three trial. We are excited about this milestone in particular, as we believe that adopting a commercial-ready manufacturing process now could lead to a more seamless NDA submission, review, and approval process without the need for bridging studies. Yesterday we announced with release therapeutics holding that we have entered into a definitive settlement agreement to resolve pending litigation at a closing to be held within the next 30 days. More details on the settlement terms can be found in the joint release published on November 13th, 2022 and will be in a future 8K filing with the SEC upon settlement. We believe that this settlement is in our shareholders' interest for the following reasons. We have committed to focusing on our core CNS franchise and Avif to Build is not part of that franchise. The institutional investors who have capitalized our company and the analysts who evaluate our company advise us to focus on our CNS franchise. Under the terms of the settlement, Avif has committed to all further costs of Avif to Build development while paying us up to 43 million in milestones and royalties should they succeed. The failure of Aviptadil in both the NIH and BARDA trials indicate limited potential for Aviptadil in widespread use. So it's a deal that I think is a real benefit for NRX shareholders. Finally, we announced the debt financing with net proceeds of $10 million on November 7th, 2022. that is expected to support our clinical development activities for NRX 101. With that, I will turn it over to Seth for a brief overview of our financial results. Seth?