Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and Full Year 2024 Earnings Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Monday, March, 17 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

Thank you, Joelle, and good morning, everyone. Welcome to our call. 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 Securities and Exchange Commission. The forward-looking statements made during this call speak only as of the day 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 this morning and the company's Form 10-K, which was filed on Friday and may be accessed from the Investor page of the NRx Pharmaceuticals, Inc. website. Joining me today on the call are Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in the 10-K and in the press release, following which Mike will review the company's financial results. Following our prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan?

Thank you, Matt. Good morning, everyone. Thank you for joining us. As you know, the Board asked me to assume leadership of NRx five months ago and to chart a path forward in the context of a capital market environment that's been less than supportive of pre revenue biotechnology company. Over the past five months, we've raised new capital, retired toxic debt and begun executing on a path that leads our enterprise from a purely research and development focused company to a healthcare company that has potential to generate revenue and look forward to profit by the end of 2025. We believe that's rare among small cap biotech companies. At NRx, we continue to be driven by our mission to treat and prevent suicidality, depression, PTSD and related disorders. While our mission has not changed, our path to revenue has advanced. Moreover, the U.S. government and particularly the new administration has expressed increased commitment to the treatment of these lethal conditions with the class of medicines and clinical approaches that are central to our business. NRx Incorporated now owns two operating entities, the original NeuroRx business and the newly created HOPE Therapeutics. All drugs under development are owned by NRx, while HOPE is focused on delivering clinical care. Under the original NeuroRx business, we've initiated filing of a New Drug Application or NDA for NRX-100, our preservative free intravenous ketamine based on stability data that support more than two years of room temperature shelf stability. We have proven manufacturing capacity to supply more than 1 million doses per month should we gain FDA approval. We believe the strategic term sheet we have received to acquire this product for more than $300 million in total milestones and a double digit royalty provides further validation of our drug development approach. NeuroRx is…

Thank you, Jonathan. For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million, and $27.8 million for the year ended December 31, 2023. This change was primarily driven by a decrease in research and development expense. For the year ended December 31st, 2024, research and development expense decreased by approximately $7.2 million or 53.6% to $6.2 million, as compared to $13.4 million for the year ended December 31, 2023. This change is primarily driven by a decrease in clinical trial and development expense due to the conclusion of the Phase 2b/3 study for NRX-101. Finally, general administrative expense for the year ended December 31, 2024 decreased by approximately $7.7 million to $13.5 million as compared to $14.2 million for the year ended December 31, 2023. This change was primarily driven by a reduction in insurance and employee costs and partially offset by the increase in consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics. As of December 31, 2024, we had approximately $1.4 million in cash and cash equivalents. As noted above, in January 2025, the company completed two financings with aggregate gross proceeds of approximately $8.5 million. Management believes the current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path of generating revenue and value for our shareholders. Please see detailed financials on our Form 10-K filed with Securities and Exchange Commission, which will also be available on our website. With that, I turn the call back to Jonathan. Jonathan?

Thank you, Michael. The mission of NRx to prevent and treat suicidality in patients with depression and PTSD has continued to move forward. Over the last year, we've streamlined operations, we've retired toxic debt, we've capitalized the company to move forward. Planned 2025 PDUFA dates for our two NDAs and continuing the development of HOPE Therapeutics national network for care delivery are transformative steps for the company and for the treatment of mental health in the United States. I'd like to thank the NRx team, our investors, and most importantly the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. Operator, we're ready to take questions from the audience.

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

Good morning, guys. Congratulations on all the progress. Couple of questions. Jonathan, you made a good argument for removing the preservative from ketamine. If you remove the preservative for ketamine, how does that change the formulation? And for example, what do you do in its place?

When you say what do you do in its place, why do you need to do anything in its place?

Why is it there in the first place? Does ketamine degrade?

Great question. So the preservative was stuck in ketamine way back when, because an anesthesiologist would put it on the cart in the hospital and would draw out of the vial multiple times. So any time you stick more than one needle into a sterile vial, it's considered to be contaminated and to require a germicidal preservative in the bottle.

Got you. Okay. Great.

So as long as you have a single-use vial, by law you don't need a preservative. Now when we started this, people said, oh yes, but that preservative is critical to the stability and sterility of ketamine. Well, it turns out not to be true. That turns out to be a novel and surprising finding. And -- that's why we've pointed out that we've now got the ability to file for two-year shelf stability at room temperature for preservative-free ketamine. And you've seen this happen in the ophthalmology industry, where it was assumed that glaucoma eyedrops and other eyedrops that people use on a long-term basis would always be in a big bottle with a preservative in it. The same was true for artificial tears that people were used to buying in the drugstore. And 15 or more years ago, I was involved in research that showed that those preservatives are actually quite toxic to the cornea and the conjunctiva. And that's why more often than not, people are buying artificial tears in single-dose preservative-free vials. And more and more of the prescription eye drops have been moved to single-dose preservative-free vials. If you read the material data sheet on benzethonium chloride, it's pretty frightening. The material data sheet says this product is caustic, it's toxic, it may cause severe burns. And clinical evidence is that, it's anything but safe.

Perfect. Thank you. I just -- I didn't make the connection during the call, but I got it now, and it makes perfect sense. Can you talk a little bit about the acquisition strategy to add more clinics this year and without giving guidance, just give us some kind of rough idea on how that acquisition is going, what's the interest level, how many clinics out there, are there particular geographies that you'd like to focus on? Talk with us a little bit about what we should expect a year from now.

Well, Florida has become a geography of focus for us, partly because we've identified a group of clinics that, in our view, are already doing it right. Not to paint with too broader brush, but you can find a ketamine clinic on every other street corner in the United States today. But many of them are clinics that do ketamine on Mondays and vitamin drips on Tuesdays and God knows what on Wednesday. Organizations that know how to combine ketamine and in the future other psychedelic drugs with neuromodulatory technology like TMS are few and far between. These are tough patients to treat on a comprehensive basis, and anybody who says, come on in for your ketamine shot and go elsewhere for the rest of your care is not doing any patient any favors. So that's why we retained BTIG and have partnered with BTIG to cast a broad net for clinics that we believe are doing it right and to use that platform of acquiring clinics as a basis for building out a nationwide network. When we talk about the kinds of financing that's available, you're talking -- about a tiered risk financing. Our conversation so far suggests that commercial banks are prepared to finance up to 50% loan to value on fairly attractive commercial terms. Our conversation so far suggests that clinic owners are willing to take some piece of the acquisition in the form of HOPE Therapeutic shares. And that leaves financing in the middle, perhaps 20% to 30% of each acquisition that will come from investors who expect a higher rate of return, but a rate of return that HOPE can certainly afford to pay. So the capital stack from our perspective is not a major impediment to getting our initial acquisitions done. The hard work is, the pile of legal documents that are required to acquire any healthcare facility in the United States, especially in states that have corporate practice of medicine laws, and the due diligence that we have to do, both on the financial front and on the regulatory front on each acquisition to make sure that these are acquisitions we can put on the balance sheet and offer to our shareholders.

Perfect. I completely understand. Thank you. One last question. In the press release, you talk a little bit about the potential for a ketamine deal, $300 million in milestones and tiered royalties, and the fact that you have -- you've received interest, non-binding term sheets. Can you expand a little bit about that because that certainly changes the company's future and creates kind of a very significant inflection point for investors?

Yes, a deal is never done till it's done. But as we've moved closer to having a marketable drug, there's a real desire out there on the part of already commercial organizations to be able to offer such a drug to patients. I don't think anybody questions the size of the available market. And having a partner that already has a sales force in the field could be more attractive than raising the money to launch the drug ourselves. So we're gratified that commercial partners have started showing up. And we've told our investors what we can say today about what that might look like.

Thanks, Jonathan. Very exciting times.

Your next question comes from Tom Shrader with BTIG. Your line is now open.

Good morning. Thanks for taking the question. Good luck on the busy year. A follow-up on the last line of questionings. The ketamine clinic landscape in Florida, is it chunky? So when you say you have nine facilities, is that one deal or is that nine independent negotiations? Should we look for this target to happen in big chunks? And then maybe if you could give us a little bit of color on having an ANDA and an NDA in front of the FDA at the same time. How unusual is that? Is it the same people that deal with it? Is your manufacturing packet enough for both? Just it's unusual to me and I thought you could talk a little bit about what it would look like at the FDA. Thank you.

So on the ketamine front, I think you should expect acquisitions to be chunky, your word, to represent more than, in general, more than one clinic at a time. In the case of Kadima, which is a one-site facility, we started there because we've been unable to identify another clinic that's doing so many things right all at the same time. But in general, the clinics that are doing it well are doing it at multiple locations. And we would expect that to be part of our acquisition path. With regard to an ANDA and an NDA. The NDA is specifically to ask the Division of Psychiatry products to add the depression and suicidality indications to the Ketamine label. And quite frankly, somebody probably could have come along and said, well, let's do that with the original formulation that has the preservative in it. But it's really a scientific exercise in attempting to prove safety and efficacy to the satisfaction of review division while also satisfying the manufacturing side of FDA. Well, that same manufacturing package, that same Module 3 that we've already submitted, while it's necessary to the new drug approval application, While it's necessary to the psychiatry indications, it's both necessary and largely sufficient for an ANDA, because under the ANDA, we're not seeking to change the label of ketamine. We're seeking to offer a preservative-free version of a drug that's already generic.

So the ANDA would be for analgesia?

The ANDA would have the same indications as the currently marketed forms of ketamine, but it wouldn't have the toxic preservative in it.

Okay. Thanks for the color.

Your next question comes from Vernon Bernardino with H.C. Wainwright. Your line is now open.

Hi, good morning, everyone. Thanks for taking my question and congrats on the progress. Looks like it will be a busy second quarter. Regarding the terms with the commercial pharmaceutical company for NRX-100, do you anticipate that will be a second quarter announcement as far as the finalization of the deal?

Well, we hope it may be. And the deal is never done until it's done. On the other hand, we see the expression of interest as one that may even become broader. So we have the resources to continue to move these applications forward. We don't need a commercial deal right now, but we would certainly welcome the right partner.

Great. Consider -- in terms of the ketamine intended for intravenous use and removing benzethonium chloride, so the idea there is single use. How easy would it be for a competitor to make their own single use presentations of ketamine for intravenous use?

Well, there are a couple of challenges that anybody who wants to enter the market will have today. Certainly, the sponsor of ketamine, who owns the label, could certainly do it, if they wanted to. But if they don't already have a preservative-free formulation for stability, they've got a couple years of work before they can enter the market and file their ANDA. Do we expect that we'll long-term have the ketamine market to ourselves? I think that's too much for anybody to expect for a market that's quite that large. But for a period of time, we may well. And if some of the advice we've received that the preservative-free formulation we've engineered is surprising and ultimately stands up to patent review, we could have that marked to ourselves for longer than anticipated.

Thanks for that additional information. Then regarding the persistent psychiatry centers you intend to acquire, those are still projected to be ones you think will have run rates of about $5 million a year in revenue?

Or larger.

Okay. And one of those you intend to acquire, you say three positions, one of those includes Kadima or these are in addition to Kadima?

That includes Kadima.

Okay. And then lastly for me, the term sheet with the publicly traded strategic investor that manufactures TMS devices, they manufacture their own or several devices or…

Probably it wouldn't be appropriate for saying anything more at this time.

Okay. Great. [Multiple Speakes] Thanks for taking my question.

Thank you.

Yes, and congrats on the progress.

Your next question comes from Ed Woo with Ascendiant Capital. Your line is now open.

Yes, congratulations on the progress. As you may potentially have NRX-100 and NRX-101 approval this year with the FDA, have you thought about what you might do internationally with both of them?

Well we've talked in previous calls and previous filings about relationships that we've developed in France, a European country that is highly focused on this disease. The French estimate that somebody becomes suicide in France every 45 seconds. And as you know, one of the clinical trials that we're citing to FDA is a French government funded study conducted at seven French hospitals. It could be the largest study ever attempted in patients with suicidal depression. So were that to continue to evolve and our relationship Foundation FundaMental result in a European filing, that would certainly have resonance throughout Europe. We've not considered going beyond US and Europe by ourselves. As you know, we've had relationships with Asia-Pacific entities. And as we gain momentum, we expect that interest to increase at the same time.

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

Ladies and gentlemen, I will now turn the call over to Matt for other questions.

Thank you, Joelle. Jonathan, we have one other question electronically that came in and that regard -- is regarding HOPE. And the question is that HOPE sounds very interesting, but how does it directly benefit NRx shareholders that NRx owns the equity in HOPE at this point?

Well, right now HOPE is an asset on the NRx balance sheet and to the extent that NRx continues to own shares of HOPE Therapeutics, if HOPE becomes profitable, those profits will roll up to the benefit of NRx. As other investors come into HOPE, those profits will devolve to the benefit of all investors in HOPE. But, you But a prominent investor is likely to remain NRx. We've talked about our desire to spin out HOPE shares to those who own NRx stocks at the time of the spinout. Yes, it was disclosed last year. That was slowed down by a toxic lender who ultimately was guided by the court that they couldn't block the HOPR spinout. So we continue to be in a position to move forward towards spinning out some of those shares, need to make sure that we do it in a tax-free manner to NRx shareholders. But meanwhile, as long as NRx is on the -- as long as HOPE is on the NRx balance sheet, anything that HOPT does devolves to the benefit of NRx shareholdings.

Okay, thank you very much. Everyone, that's all the time we have for questions today. Thank you, everyone, for joining us this morning. We're extremely excited about the year ahead and with our two potential drug approvals and a subsidiary targeting multiple profitable mental health clinics. This concludes the NRx Pharmaceuticals fourth quarter 2024 results conference call. Thank you all for participating and have a great day.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.