Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Third Quarter 2024 Earnings Conference Call. At this time, all lines are in the listen-only mode. Following the presentation we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Monday, November 18, 2024. I would now like to turn the conference over to Mr. Matthew Duffy, Chief Business Officer. Please go ahead.

Thank you, Ina, and 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 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 may be 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 last week as well as the Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals website. Joining me today on the call are Dr. Jonathan Javitt, our Founder, Chairman and CEO and Chief Scientist; as well as Richard Narido, our Interim Chief Financial Officer and Treasurer; and Michael Abrams, our incoming CFO. Jonathan will provide a summary of our company's progress, Rich will review the company's financial results, Mike will make some comments, and then Jonathan will review our upcoming milestones before making closing comments. Following our prepared remarks, we will address investor questions. I'll now turn the call over to Jonathan.

Thank you, Matt. Good evening, everyone, and thank you for joining us. As you saw, we decided to do our conference call a day or two after our quarterly report in order to make our calls a bit more convenient for the increasing number of analysts who are covering our company and to encompass today's important news. The last few months have been incredibly productive for NRx and for Hope Therapeutics. In our view, they represent a positive inflection point in our path to market entry and profitability. On the NRx side, we continue to advance our life-saving products, and our NRX-100, that's our IV ketamine, and NRX-101, our oral treatment for suicidal bipolar depression, for new drug application filings in 2024. Further, our wholly-owned subsidiary, Hope Therapeutics, aims to be the business of delivering life-saving care to people with suicidal depression and PTSD by year-end, with its first revenues being generated. To that end, Hope has signed nonbinding letters of intent to acquire two foundational interventional psychiatry groups which are currently revenue generating and EBITDA positive. We have received initial nonbinding commitments from lenders for nondilutive acquisition financing of Hope clinics and are in the final stages of the underwriting process for those acquisitions. This puts NRx in a unique position as the only company dedicated to developing a comprehensive care path for the prevention and treatment of suicidality. We recognize the need to augment drug development with a care delivery model because of the emerging evidence that ketamine may be essential but not sufficient to achieve a long-term benefit for people with suicidal depression. For at least some patients, our precision psychiatry approach is required. That includes ketamine, transcranial magnetic stimulation and other modalities. This model of care is difficult to access for many patients and is not…

Thank you, Jonathan. For the three months ended September 30, 2024, NRx pharmaceuticals reduced its operating net loss by nearly 75% year-over-year from $6.1 million in the third quarter to $1.6 million in 2024. For that same period, research and development expenses decreased from $3.3 million in 2023 to $0.6 million in 2024. The $2.7 million decrease is related primarily to the decrease of $2.1 million in clinical trial and development expenses due to the conclusion of the Phase IIb/III study relating to NRX-101 and the company's cash conservation efforts. Also in that three month period, NRx achieved a slight decrease in general and administrative expenses from $2.5 million in 2023 to $2.4 million in 2024. For the nine months ended September 30, 2024, NRx Pharmaceuticals reduced its net loss to $16.1 million compared to $25.8 million in the prior year. These efficiencies represent an improvement in net loss of $9.7 million year-over-year and a $1.89 or 54% improvement in net loss per share year-over-year. Over that nine month period, we recorded $5.2 million of research and development expenses compared to $10.8 million for the same period in 2023, representing a 52% decrease year-over-year. The decrease of $5.6 million is related primarily to the decrease of $6.1 million in clinical trial and development expenses due to the conclusion of the Phase IIb/III study relating to NRX-101, and offset by $1.3 million related to Alvogen warrants and $0.2 million related to fees paid to regulatory and development consultants. Also in that nine month period, we decreased G&A by $1.4 million, from $12.3 million in 2023 to $10.9 million in 2024, representing an 11% decrease year-over-year. As of September 30, 2024, we had $1.6 million in cash and cash equivalents. Subsequent to September 30, 2024, we added the cash by closing tranche two of the secured debt financing from Anson Funds in the amount of $5.4 million. This financing is expected to support filing of new drug applications for NRX-100 ketamine and NRX-101, general corporate purposes as well as to retire historical debt on more favorable terms and lower interest rates. NRx continues to implement operational efficiencies, to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders. With that, I will turn it back to Jonathan.

Thank you, Rich. We look forward to your ongoing support as Hope takes shape and we're able to bring life-saving therapies to patients across the world. Today, we announced that NRx has appointed Michael Abrams as our permanent CFO. Mike brings a wealth of experience both as a public company CFO and in the capital markets, a background well-suited to our long-term goals. Welcome, Mike. Please introduce yourself to our shareholders.

Thank you, Jonathan. I'm excited to join the NRx team at such an important time for the company. In prior engagements, I've joined companies just as they were poised to transition to revenue generation, and look forward to shepherding NRx through that exciting phase. With major milestones expected in the near term, I see NRx as a unique opportunity and look forward to great things for the company and our shareholders. Jonathan?

Thank you, Mike. We're looking forward to working with you. NRx is dedicated to preventing and treating suicidality in patients with depression and PTSD. Filing our 2 NDAs in the near term and continuing the development of Hope Therapeutics national network for care delivery are transformative steps for the company and for the treatment of patients. I'd like to thank our team, our investors and most importantly, the patients who participated in our clinical trials, for their steadfast support in pursuit of this vision. Operator, we're ready to take questions from the audience.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Jason Kolbert from D. Boral Capital. Please go ahead.

Good afternoon. Thanks for the update. Jonathan, I'd like to zoom in a little bit on the accelerated approval, what you think is involved in that process? And if you get it, what does that mean in terms of a PDUFA data and the time line for both? And I know you're really talking about NRX-101, but kind of what is the PDUFA date, do you think, and the time line likely for NRX-100 as well? Thanks.

So in order to sort of unpack those questions, accelerated approval is a process, and people can look this up on the FDA website, where a sponsor has identified an important intermediate end point for a drug, but has not necessarily identified sufficient efficacy data for permanent approval of that drug. So in the case of NRX-101, what we've not yet done is a 300- to 500-person clinical trial of NRX-101 against placebo to prove that it's better than placebo, although we know that its components have beaten placebo in multiple trials, especially lurasidone. On the other hand, we now have two clinical trials where NRX-101 has demonstrated reduction in suicidality and akathisia compared to lurasidone. And we believe that akathisia and suicidality are critical intermediate end points. We don't have proof that they're associated with long-term survival, but we certainly know that suicidality can be associated with short-term demise. So therefore, we intend to seek accelerated approval, which is a process by which FDA grants five years of marketing rights to a drug, during which time, permanent data, permanent approval can be obtained. Now you may say, how are we ever going to get that long-term data? Well, there's a national PCORI study spinning up where patients are being randomized to different currently marketed drugs for treating bipolar depression. And within that study, there is not yet any arm for drug therapy of patients who have suicidality and akathisia. The only treatment that's approved for suicidality today is electric convulsive therapy. We've been in touch with the investigators of that study, and we think it's not unlikely that, that may be the place where patients in large numbers are randomized to NRX-101 over the next five years in a manner that gains permanent approval. We're not ruling out the…

It does. It's a great answer. Thanks you. Can I ask you to talk a little bit -- switching gears and thinking about Hope. And you talked a little bit about the difference between kind of ketamine clinics that focus on doing various infusions for people and a real psychiatric center. And so my question is, are you finding motivated folks that really want to build that all-in-one comprehensive psychiatric center? And do you think you're going to be able to acquire them in a way that you really will develop a national footprint?

Well, I think what's fair to say is that we -- having done a pretty broad canvassing of what's out there, we have identified some clinics that are doing it the right way, that are combining ketamine, TMS, good psychiatric medical management and traditional therapy in an integrated model that best serves patients. We've been able to prove to ourselves that those clinics are able to operate at a healthy operating margin, somewhere in the neighborhood of 30%, and by virtue of the fact that some of those organizations have signed letters of intent to be acquired by us, we believe that our business model is a feasible one. Are these clinics the minority of what's out there today? For sure. People have seen private equity acquisition models with clinics that have sort of come and gone. Some have succeeded, some have not. We believe that, that integrated precision psychiatry model is what's needed to have both staying power in the marketplace and really to provide the maximum benefit to patients.

Perfect. And I just want to try to throw a question at Mike today. Mike, Jason Kolbert. Great to hear you again. We've known each other for a while. Great company. You should be excited to be there. I'm sure you are. In the press release for the third quarter, there was language talking about revenues this year and profitability next year. So can you talk a little bit about kind of what -- when you did your due diligence to join the firm, how you're looking at kind of the revenue build over the next year?

So in full disclosure -- thank you, Jason. In full disclosure, those were -- that's not my build, right? But I did...

I know it's not a fair question, but I know you did due diligence.

Yes, but I did due diligence on it. So look, it's a function of -- in a lot of respects, these things are a numbers game, right? There are a certain number of clinics that meet the model that Jonathan and his team have built. There's certain levels of profitability that can be expected from those. So if you look at the clinics that they've already had discussions with in terms of LOIs and extrapolate the additional ones that can be added into the fold, it's not difficult to see, because they've already done and completed a good number of audits on those potential acquisitions. So it's just building a model from A plus B plus C plus D, and then the numbers kind of fall out of it. So while there's still a lot of work to be done, obviously, they've made -- my results of my initial diligence were that the numbers are there and they can build on them. So I had a lot of confidence. Obviously, there's a lot of execution that needs to happen in that regard. And secondly, on the larger one, now you start getting into factoring both NRX-100 and NRX-101 so you could start building the model by multiple sources there. And there, you just have to look at, or what I did, look at the overall market opportunity. And when they talk about, from the quotation from the CDC or the stats from the CDC where, the United States of America, someone dies by their own hand once every 11 minutes and once every minute internationally, obviously, the demand is there. So if we can truly prove -- this company can truly prove that it is a solution that provides better outcomes for patients, the market's there and then it's just about executing on it. So those are the things in my diligence that made me excited and very enthusiastic about joining the company. Does that answer your question?

Yes, it does. And it sounds like you share Jonathan's vision and what I see in the company, which is it's a fractured system with many different therapies, and nobody seems to be pulling it all together in one central place for patients, which is what has to be done to save lives. So I mean it's a noble cause. Thanks so much. Appreciate the update.

Thank you. And your next question comes from the line of Ed Woo from Ascendiant Capital. Please go ahead.

Yes. Congratulations on all the progress. In terms of the valuations for these precision psychiatry clinics, are there any issues in terms of finding enough of these clinics at a reasonable valuations? Or do the valuations really fluctuate wildly? And have you thought about possibly building as opposed to buying? Thank you.

Thank you. It's really a great question. And I think we're going into this knowing that there aren't nearly enough clinics that meet our model, the model that we've laid out in this call, to build a national network. So then our choices will be acquiring clinics that meet some piece of the model and enhancing their offering to where they're able to meet the whole model versus literally going and building out space and hiring caregivers, and building a clinic from the ground up. And we know that capital is available for both of those, and we'll be opportunistic in terms of what we do. What you probably won't see us do is take over a medspa that's doing ketamine on Monday and vitamin drips on Tuesday and put our name on it.

Great. Well, thanks for answering my questions. And I wish you guys good luck. Thank you.

Thank you. And your next question comes from the line of Vernon Bernardino from H.C. Wainwright. Please go ahead.

Hi, good afternoon, everyone. Congrats on the progress and the exciting changes and structure of the company to come. Just had a question as far as revenue recognition, perhaps. You're pretty confident, Jonathan, about recognizing some form of revenue this quarter. Just wondering, that's contingent on all the things that are pointing to signing on the dotted line, right? And in that recognition and signing, is that something where the revenue generated from that day plus one is the revenue you'll be recognizing? Or will you also, as part of the acquisition, be recognizing the, let's say, historical for the beginning of this quarter when you have the structure in place?

Yes. That's really a Mike Abrams question, and it may even be one where he needs to come back to you in a note that we'll share with both you and the public. But what I said is that by the end of the year, we expect to have aggregated organizations that are generating revenue. I'm not an accountant, and I certainly am not an expert on U.S. GAAP as it relates to recognition of revenue for medical services, so if Mike's comfortable talking about our general approach to recognizing revenue, he's welcome to. But at the same time, he's now about to go into a series of conversations with our public auditors where we set some ground rules for how and when we're going to recognize revenue. So Mike, let me turn it over to you.

Thank you, Jonathan. I don't have a lot to add besides that. I think you handled that very well, Jonathan. I mean revenue recognition, as everyone knows, is a very complicated subject, and that's gone through a lot of change with different ASC announcements, 606 notwithstanding, over the last couple of years. So I would -- to be responsible in my response to that, I would much prefer to have had an opportunity to have detailed discussions with our auditors and work through it. The one thing I can guarantee you is that this company, in concert with adherence to GAAP and working with our auditors, the revenue recognition policies will be defensible and compliant. But other than that, I really don't feel it's appropriate at this point to get into any more detail or specifics on the revenue recognition side.

Okay. As a follow-up to that, though, when you do perhaps give some kind of insight or maybe even some guidance, will you be providing some level of detail as far as how well are the level of business these entities actually realize?

Yes. When we do discuss it publicly, the description and the disclosure will be complete and encompass all of the known facts at the time that we disclose it. But at that point -- we're not quite there yet.

Okay. Thanks for taking my questions. Congrats. Welcome aboard, Michael. Looking forward to working with you. Thanks, Jonathan.

Thank you.

Thank you. There are no further questions at this time. I will now hand the call back to Mr. Matthew Duffy for any closing remarks.

Thank you, Ina, and thank you, everyone, for joining us this evening. We're extremely excited about the coming months and quarters and years, the two potential drug approvals and subsidiary targeting multiple profitable precision psychiatry clinics. This concludes the NRx Pharmaceuticals Third Quarter 2024 Results Conference call. Thank you for participating, and you may disconnect.