Good day, everyone, and welcome to NRx Pharmaceuticals’ First Quarter 2023 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Suzanne Messere with Stern, Investor Relations. Please go ahead.

Thank you, Vashnavi. 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 earlier today and in the Company's Form 10-K, which was re-filed on May 1, which may be accessed from the Investors page of the NRx Pharmaceuticals Inc. website. Joining me on today's 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 milestone before making closing comments. Following their prepared remarks, Stephen and Seth will be joined by Jonathan Javitt, the Company's Chief Scientist and Matthew Duffy, the Company's Chief Business Officer to address your questions. I will now turn the call over to Stephen.

Thank you, Suzanne. Good morning everyone and thank you for joining us to discuss our continued success, as we advance our pipeline of innovative therapeutics for patients facing psychiatric disorders with great unmet need, including treatment resistant suicidal bipolar depression, post-traumatic stress disorder and potentially chronic pain related to depression. Today, we will discuss first quarter 2023 results, and provide a business update. 2023 is off to a great start as we continue to build our leading brain health franchise, advancing our compelling science and building long-term value for our shareholders. In recent months, we've made great strides in our clinical trials for our lead product candidate and NRX-101 while continuing to execute on our corporate strategy. To summarize, we aligned with the FDA on the chemistry manufacturing and controls of NRX-101 as well as a path to commercial stage product, and continue to align with the FDA on a potential path for approval of NRX-101 in a Type B meeting. We announced encouraging findings of our independent Data Safety and Monitoring Board or DSMB, whose first evaluation of unblinded data identified no safety concerns and subsequent evaluation indicated that no safety or futility signals were reported in the first 50 patients treated, and provided a positive recommendation to continue enrollment. And based on FDA interactions and DSMB findings, we are consolidating our two clinical trials of NRX-101 in suicidal bipolar depression into one study for patients with Suicidal Treatment-Resistant Bipolar Depression. I'll begin by reviewing recent progress made for NRX-101 in Suicidal Treatment-Resistant Bipolar Depression, PTSD and chronic pain. NRX-101 is a fixed dose combination of D-cycloserine, an NMDA receptor regulator and lurasidone, a standard-of-care medicine for use in treatment resistant bipolar depression. There are approximately 7 million people living with bipolar depression in the U.S. and the risk…

Good morning, everyone. Thank you, Stephen. I will now review the highlights for first quarter 2023 financial results. For the three months ended March 31, 2023, NRx Pharmaceuticals recorded $3.7 million of R&D expenses compared to $5.5 million for the quarter ended March 31, 2022. The decrease of $1.8 million is related primarily to a reduction in clinical trials and development expense related to our discontinued activities related to ZYESAMI. For the three months ended March 31, 2023 NRx Pharmaceuticals recorded $5.8 million of G&A expenses compared to $10.2 million for the three months ended March 31, 2022. The decrease of $4.4 million was primarily related to a decrease in legal, professional and accounting fees. Our net loss for the quarter was $11 million an improvement of $2.4 million compared to the net loss of $13.4 million for the comparable quarter in 2022. On the financial side, our cash resources were enhanced in March when we entered into a securities purchase agreement with accredited investors who had previously established positions in the Company. This transaction involved the sale of approximately 3.9 million shares of the Company's common stock and a five year warrant in a registered direct offering priced slightly above the market at $0.75 per unit for the securities. The investors agreed not to sell these shares of common stock or exercise the warrants for six months following the issuance date. The aggregate gross proceeds from to the Company for the offering was approximately $2.9 million. As of March 31, 2023 we had approximately $16.5 million in cash. Assuming future debt payments can continue to be made in stock, the $16.5 million of cash and cash equivalents at the end of the first quarter of 2023 is expected to fund the Company's operations through the expected delivery of data in the fourth quarter of this year from our Phase 2b/3 trial. Additionally, we are evaluating operation efficiencies associated with the completion of our manufacturing activities as well as considering capital raising activities to extend this runway. With that, I'll turn it back to Steve for closing remarks. Steve?

Thanks, Seth. The past quarter has been incredibly productive. And we look forward to advancing our NRX-101 program in suicidal bipolar depression, PTSD and chronic pain in the months to come. Based on the experience we have as a clinical trial Company working in CNS, NRx is uniquely positioned for success in future growth. We plan to build on a momentum in the remainder of 2023 as we continue to execute on multiple regulatory and clinical catalysts. We believe that NRX-101 is a potentially life-saving medicine that could change the treatment paradigm for life threatening psychiatric conditions which is the driving force behind our mission to meeting the needs of underserved patients with serious CNS disorders. We look forward to updating you on the near-term milestones, which are on-track for the coming year, including the initiation of our study of NRX-101 and PTSD, the advancement of NRX-101 and chronic pain associated with depression, as well as future updates on breakthrough therapy designation meeting for NRX-101 in treatment resistant suicidal bipolar depression as well as data from our Phase 2b/3 study in the fourth quarter. With the shared commitment of our investors, our team and our researchers we aim to bring hope to the millions of patients with suicidal bipolar depression and PTSD who have been systematically excluded from trials of previous antidepressants. Operator, we are ready to take questions from the call.

Alright. Then we will begin the question-and-answer session. [Operator Instructions]. Our first question comes from Ed Woo with Ascendiant Capital. Please go ahead.

Yes, thank you for taking my question. My question is on PTSD additional indication. Do you anticipate starting filing the IND this quarter or the next quarter in order to start a trial by the fourth quarter?

Thank you, Ed. This is Jonathan Javitt. Yes, we do anticipate filing that IND.

Great. And then in terms of how large the possible trial can be. Do you have any indications of how big it may be?

Well, I think from a registration perspective, there were some precedents from the anti-depressants recent approvals. But until there's a formal meeting with FDA, it's not possible to know exactly what the sample size would be. But I think there's some good precedence in recent approvals of anti-depressants.

Great. And then my last question is in terms of what you guys have learned with your current study, do you think that you'll be able to use any of that data in order facilitate the trial possibly being easier or being able to go faster?

Well, certainly, a trial for any indication adds to the safety database for all indications and clinical experience with a drug is always helpful, but the endpoints in PTSD are a little different than the endpoints in depression because in PTSD, you're primarily relying on the [CAPS 5] (ph) scale looking at symptoms of flashbacks and recurring memory, sorry, recurring care memory. Some of that's been demonstrated with ketamine, which as you know is a very potent MDA antagonist. So there's reason to be optimistic that a more controllable MDA antagonist might also relieve symptoms of PTSD.

Great. Well, thanks for giving me the answer, and I wish you guy’s good luck. Thank you.

Thank you, Ed.

The next question comes from Jason Kolbert with Dawson James. Please go ahead.

Hi, guys. Congratulations on the progress.

Good morning, Jason. Thank you.

Good morning. Can you talk a little bit about the dynamics of actually enrolling these bipolar depressed patients with suicide ideology? And how do they come to you? How do they end up being referred into the trial? What's the entry criteria on these patients? And then I want to talk a little bit about what are the endpoints of the trial?

Thank you, Jason. As you know, we put the protocol for the trial on to www.clinicaltrials.gov, so people are free to read it. And the trial enrols patients who have severe depression as measured by a score of 30 or higher on the MADRS scale and also have suicidal ideation to the extent that they have a score of 3 or higher on the Columbia suicide severity rating scale. So historically, we've relied on traditional study sites to recruit these patients either from the patients that they already know in their clinical treatment programs or patients that they're able to reach out to in the community. As Steve discussed earlier in the call, we've decided to go broader than that. And we've engaged 1nHealth really to stand up a recruitment effort that's licensed in 45 states so far, in conjunction with a decentralized clinical trials organization called Science 37 such that we're able to recruit patients in most of the country. And we're in the process of reaching out to a very large pool of people who've identified themselves as having bipolar depression. And rather than demand that those patients come to a study site that could be some distance away from them we have teams of nurses who are able to go do the initial screening at a location convenient to the potential participant including their home to draw blood as needed by the protocol, again, at their location, And then we have psychometric raters who are able to do the assessments associated with the primary and secondary endpoints for the study on a remote basis. And we anticipate that by opening up our recruitment in that manner, we can much more efficiently recruit patients into the study, make it easier for them to stay in the study and at the same time be able to control the quality of the data through a very small pool of very highly experienced raters.

Yeah. I mean, I can appreciate the infrastructure required to accomplish all of that. And given where you are, how confident are you in the velocity of enrolment that supports that statement that you're funded through kind of the data read at the end of the year?

Well, prediction is challenging, especially as Yogi Berra once said when you're talking about the future. What we can tell you is that in the first week of the 1nHealth initiative, there were 150 inbound inquiries of which 75 were patients who were deemed to potentially meet the study criteria. So the interest in this study is very palpable and by the time we speak again, I think we'll have a very good handle on the velocity with which enrolment can be achieved.

Okay. Thank you. And can you break down for me just review with me the primary endpoint and what exactly the components of it are that are measured?

So the primary endpoint is very clear cut. It's the same primary endpoint that was used to approve lurasidone. It's same primary endpoint that was used to [improve ability] (ph), which is change in the MADRS, depression score at the Montgomery as per depression rating scale over 42 days using what's called a mixed model repeated measures regression. All of that's described in detail in our protocol, which people are free to read. And the secondary endpoint, the key secondaries are measurement, what time to treatment failure? In other words, how long is it between the time you start the study and the time that the treating physicians determine that the medicine you were randomized to isn't working. That's one secondary endpoint. And the other secondary endpoint is change in the clinical global impression suicides severity scale, which is a scale that we saw significant change in the STABIL-B study in the Phase 2 studies that are in this breakthrough therapy designation. So the endpoints are quite transparent in that regard.

Really appreciate the update. Thank you. We'll be watching the progress.

Thank you.

As we have no further questions, this concludes our question-and-answer session. I would like to turn the conference back over to Suzanne for any closing remarks.

Thank you, everyone. That is all the time we have for questions. Thank you for joining us this morning. This concludes the NRx Pharmaceuticals first quarter 2023 financial results conference call. Have a great day.

The conference is now concluded. Thank you for your participation, you may now disconnect.