Thank you for standing by. This is the conference operator. Welcome to NRX Pharmaceuticals' Third Quarter 2023 Earnings Conference Call. As a reminder, all participants are in listen-only mode. The conference is being recorded. After the presentation, there will be an opportunity to questions. [Operator Instructions] I would now like to turn the conference over to Mr. Matthew Duffy, Chief Business Officer. Please go ahead.

Thank you, Ashia. 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 US 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-Q that was filed earlier today, which may be accessed from the Investor's page of the NRX Pharmaceuticals, Inc. website. Joining me on the call are Stephen Willard, our Chief Executive Officer; Dr. Jonathan Javitt, our Founder and Chief Scientist; and Richard Narido, Chief Financial Officer and Treasurer. Stephen and Jonathan will provide a summary of the company's progress. Richard will review the company's financial results, and then Stephen will review upcoming milestones before making closing comments. Following their prepared remarks, we will address investor questions. I'll now turn the call over to Stephen. Steve?

Thank you, Matt. Good afternoon everyone and thank you for joining us. The third quarter represents a potential turning point for our company as we are approaching our clinical trial enrollment goals for our partnered foundation product, NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. We expect four potential upcoming milestones. First, our core clinical trial of NRX-101 for treatment-resistant bipolar depression with suicidality. Second, the near-term readout of the Department of Defense funded clinical trial of D-cycloserine for chronic pain. Third, our program to seek a new drug approval for intravenous ketamine, which we have designated as NRX-100, and established that drug in a new firstly-capitalized company that aims to be cash flow positive by year-end 2024. And fourth, the near-term approval of our investigational new drug application and award of qualified infectious disease product classification to NRX-101 in complicated urinary tract infection, which is called CUTI. Achieving any one of those catalysts has the potential to unlock substantial shareholder value. Our success on more than one front has the potential to unlock exponential growth. I'm incredibly proud of our team, our collaborators, and partners, and most of all, the patients who have made such an important contribution to these efforts. All of us at NRX are deeply grateful to the many shareholders who have reached out to us, encouraged us, and supported us for a period of immense challenge in the biotechnology market. Together, we are pursuing NRX's goal of bringing hope to life on a daily basis. Now I would like to invite Dr. Jonathan Javitt, our Chief Scientist to review our clinical development program

Thank you, Steve. Let's lead off with our foundational program or NRX-101 for Suicidal Bipolar Depression. We restarted this program in March 2022 on the tail of the COVID pandemic. In the subsequent 18 months, we've transferred our manufacturing to the US, gained FDA alignment for our CMC instability program, manufactured approximately 1 million capsules of NRX-101 and relaunched our clinical program. We're excited to announce today that the company is near completing enrollment of the originally targeted 70 patients in the Phase 2b/3 trial. I believe as of yesterday, the number was 69. We've decided to continue enrollment through the end of the month and to target 74 evaluable patients randomized to NRX-101 versus standard of care medicine. The results of this trial have the potential to be used for registration filings. This target population is based on the company's January 2023 meeting with the FDA in which the company was guided to expand its intended use of NRX-101 from the original population of patients with acute suicidality who might be treated in a hospital environment to the broader population of patients with subacute suicidal ideation, which we now describe as treatment-resistant bipolar depression. In other words, patients who are treated in the outpatient setting. Based on the guidance of the FDA and the company's completion of manufacturing for Phase 3 commercial stage investigational products, we upgraded the ongoing clinical trial to a Phase 2b/3 trial earlier this year. In our last call, I shared with you the steps that we've taken to set a new standard for reliability of the MADRS, that is the Montgomery-Åsberg Depression Rating Scale measurement in trials such as this. The MADRS scale is our primary endpoint in this study and then virtually all industry depression studies. The industry has previously accepted a six…

Thank you, Jonathan, and good afternoon, everyone. I will now review the highlights of our third quarter 2023 financial results. Before reviewing the numbers, it's important to recognize that we have consistent to reduce our cash expenditures and expect to further reduce load expenditures as we complete the NRX-101 clinical trial. In August, the company entered into a securities purchase agreement pursuant to which the company issued 3 million shares of the company's Series A convertible preferred spot and one investor want for every share of Series A preferred stock issue. The aggregate proceeds of the company from the private placement was approximately $1.2 million before expenses. The company intends to use the net proceeds from such offering for working capital and general corporate purposes. For the three months ended September 30, 2023, NRx Pharmaceuticals recorded $3.3 million of research and development expenses compared to $4.1 million for the three months ended September 30, 2022. The decrease is related primarily to clinical development expenses and fees paid to regulatory and product development expenses. For the same three-month period, we recorded a 50% reduction in general and administrative expenses from $5 million in the third quarter of 2022 to $2.5 million for the three months ended September 30, 2023. The decrease of $2.5 million in related primarily to peak leases and employee-related expenses, legal, insurance and accounting costs. The nine-month period from January through September 2023 similarly shows decreased expenditures as reflected in our financial statements compared to the prior year. As of September 30, 2023, we had $8.9 million in cash and cash equivalents. These working capital assets are expected to fund the company's operations through the expected achievement of the four key milestones discussed today. Additionally, we are evaluating operational efficiencies associated with the completion of manufacturing activities to extend this runway. With that, I will turn it back to Steve for closing remarks. Steve?

Thanks, Rich. In the next several months, we expect to see multiple efforts at NRx come to fruition, which we believe may provide significant upside to our investors. We are near completion of enrollment in our suicidal bipolar depression trial with NRX-101 and are moving towards data early next year. We await data from Northwestern University's Department of Defense funded trial in chronic pain. We expect to receive our response from FDA on our qualified infectious disease product request for NRX-101 in urinary tract infection, and we expect to position NRX-100 in a new entity to file an NDA for IV ketamine and suicidal depression in the first part of next year. Investors have expressed some concern about whether we will maintain compliance with NASDAQ listing requirements. We are working closely with NASDAQ staff and outside consultants in that regard. As we said in our 8-K filing, achieving any of the four milestones identified above has the potential to lift our stock to price range required by NASDAQ. As those milestones play out, we will continue to act in a manner that is most supportive of our shareholders. For a small biotechnology company, we have tremendous amount of opportunity to build shareholder value arriving in the near-term. I'm incredibly proud of our team, our collaborators, and partners and most of all, the patients, who have made such an important contribution to these efforts. Together, we are pursuing NRX's goal of bringing hope to life on a daily basis. Operator, we are ready to take questions.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Ed Woo with Ascendiant Capital. Please go ahead.

Thank you for taking my question. My question is as you guys start pursuing opportunities with chronic pain and infectious disease, does this affect your partnership with Lotus or Alvogen? And do they have any opportunities to have first rights to get involved with this with you?

There is a right of -- thank you, Ed. There is a right of first negotiation, but it's not a right of first refusal.

Great. And what kind of negotiation process? And when do they have to make a decision process? Or is it something that's going to be ongoing with your clinical trials?

I believe the -- it will be ongoing. But I believe that they have 10 days from when we make a proposal to give us a decision. And then we're free to partner the product in ways that are no less favorable to NRX.

Great. Thank you for providing the question -- answers to my question. Thank you and I wish you guys good luck.

Ashia, this is Matt Duffy, and I have received some electronic questions for management here. The first one, I think you would go to Stephen, it looks like it dovetails off that last one, which is how is the partnership with Alvogen going so far in general?

I think it's going really well. I mean I have a good working relationship with the CEO of Alvogen. We've established a number of committees to meet regularly. And it seems like we're generally storaging alignment on our goals for development and commercialization of the project.

Okay, great. Another question came in and just I think for Dr. Javitt. Can you tell us more about your plans for the ketamine spin-off, the assets, potential funding benefit to NRX shareholders?

Well, I think it's important to start out by understanding the challenge that that we have, we're -- on one hand, we've been working for many years to develop NRX-101 as a core asset, a drug that could readily be worth multiple billions of dollars if it succeeds in clinical trials compared to the projects in ketamine and complicated UTI that while they're enormously attractive and they're nearer term in terms of their opportunity, ultimately, there's smaller revenue opportunity with very meaningful revenue opportunities. I mentioned, for example, if ketamine generated $100 million a year of profit well, you're talking about a company like ours at its current cap table, that's more than $1 a share. So there are enormously attractive opportunities for shareholders and at the same time, creating dilution within the core company wouldn't make all that much sense for shareholders. And that's why, in our view, the most attractive opportunity for our current shareholders is to create these spin-offs where we've already seen appetite from new investors to come in, help fund the spin-offs, but do it in a way that current investors will benefit in proportion to their current shareholder. Now we can't talk too much about the details because that's something that's going to be part of our upcoming annual meeting and deliberation with our shareholders. But that's the general reason for thinking about the spin-off structure.

Okay. And sticking with the IV ketamine, One other question is it's more of a clinical one for you. I think Dr. Javitt. Is IV ketamine really that much better than inhaled?

Well, we know from extensive literature and now from two well controlled randomized prospective trials and IV ketamine works against acute suicidality. And in health ketamine has never demonstrated that in a large multi-center trial. What's important to recognize is that when you give ketamine IV, you know exactly what your blood levels are at every moment of the infusion. When you put ketamine in the nose, you get an immediate spike at ketamine, followed by a tailing off and you have a much less stable blood level. But more importantly, just because you put ketamine in the nose, you don't really know how it's flowing to get into the bloodstream of any individual patient. Some will go down the back of the throat into the stomach can get absorbed, some may go across the tissues of the nose directly into the bloodstream. And it's going to vary patient-by-patient. It's going to vary in terms of how the nasal administration is carried out. And in fact, you wind up in a situation where you're creating a drug device combination with a nasal spray that has to be regulated as a medical device. So nasal ketamine has a history of disappointing industry. In 2006, there was a major failure associated with the clinical trial for nasal ketamine and treatment of chronic pain. So from our perspective, IV ketamine is something that's ready for the market. It's being used widely off-label. It's essentially become a national standard of care and we believe that an FDA labeled tamper-resistant diversion resistant form of ketamine that's manufactured to current standards, not just the standards that were in place when ketamine was developed as anesthetic, but manufactured to current standards is an important public health initiative. And that's why we've chosen to embrace it.

Okay. Very good. Thanks. We have time for one more question. And here it is the Department of Defense study in pain is positive. What do you see as the clinical and regulatory pathway for NRX-101 in pain?

Well, we've already filed an investigational new drug application with the FDA for the use of NRX-101 in pain and received an enthusiastic response or response that we've seen is enthusiastic from the FDA Division of Anesthesia, analgesia and addiction products, which is a division that regulates pain products. Clearly, if the DoD trial is positive, that would be a critical piece of evidence, but additional randomized controlled trials with NRX-101 in its commercial presentation would be required. We've talked about some of the non-dilutive capital that's available, not only through the NIH, but we would expect that the Department of Defense would want to continue development of this drug because there's such an acute need within DoD and elsewhere for a non-addictive non-opioid pain medication. And certainly, a major initiative in chronic pain would require a capital raise from NRX side. But we have ample belief that, that capital would be available in the face of a positive readout in the 200-person trial.

Thank you very much. Thank you, everyone. That's all the time we have for questions tonight. We appreciate you joining us. I'm just talking about our journey, reaching these important milestones for the company over the coming months and look forward to your participation in future calls. This concludes the NRX Pharmaceuticals third quarter conference call. Thank you all for participating.

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.