Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Q4 2025 Results Conference Call. [Operator Instructions] This call is being recorded on Tuesday, March 24, 2026. I would now like to turn the conference over to Michael Abrams, CFO. Please go ahead.

Thank you, Joelle, 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 the United States 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 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 today and in the company's Form 10-K, which may be accessed from the Investors page on the NRx Pharmaceuticals website. Joining me on the call today is Dr. Jonathan Javitt, our Founder, Chairman and CEO. Dr. Javitt will provide an overview of our company's progress as reported yesterday on Form 10-K, following which, I will review our financial results. Following their prepared remarks -- these prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan?

Thank you, Mike. Good morning, everyone. Thank you for joining us. 2025 was a pivotal and transformative year for NRx and for its HOPE Therapeutics subsidiary. We've advanced each of our programs with a drug approval anticipated for KETAFREE over the summer potential for drug approval this year for NRX-100 and a dramatically expanded opportunity for NRX-101. Our HOPE therapeutics clinics are demonstrating EBITDA positive revenue growth. Most importantly, given our low cash burn, we only need to be successful on one of those fronts to reach pro forma profitability by the end of the year. Of course, the 10-K only demonstrates the impact of first quarter of clinical operations, i.e., the fourth quarter was our first quarter of operations so you can interpolate that over a full year. We've ended 2025 a far stronger company than when the year began. Our 10-K documents a year-over-year reduction in expenses from operations even as we move far closer to potential FDA approval. We eliminated all convertible debt from our balance sheet and ended the year with a $7.8 million of cash on hand. More importantly, with the growing revenues from operations and ongoing ATM activities, we anticipate adequate cash resources to support operations at least through 2026 by which time we aim to be a fully commercial pharmaceutical company and to own a substantially larger clinical network. Let's start with an overview for each of our development programs beginning with our Abbreviated New Drug Application or ANDA for preservative free ketamine, which we call KETAFREE while we're waiting for a final trade name from FDA. In August 2025, FDA approved our suitability petition for our proposed strength of preservative-free ketamine. We filed the ANDA in September 2025. And in November, received notification that FDA noted no significant deficiencies and agreed to…

Thank you, Jonathan. For the year ended December 31, 2025, NRx Pharmaceuticals reduced its loss from operations by approximately $2.3 million to $16.2 million from $18.5 million for the year ended December 31, 2024, which was primarily driven by a decrease in research and development expense. For the year ended December 31, 2025, research and development expense decreased by approximately $2.4 million to $3.8 million as compared to $6.2 million for the year ended December 31, 2024, primarily driven by a decrease in clinical trial and development expense. Finally, general and administrative expense for the year ended December 31, 2025, decreased by approximately $0.4 million to $13.1 million as compared to $13.5 million for the year ended December 31, 2024, primarily driven by certain ongoing cost reduction initiatives. As of December 31, 2025, we had approximately $7.8 million in cash and cash equivalents. Management believes that the current available cash resources in concert with anticipated growth in total clinic revenue, ongoing cost reduction initiatives and current availability and trends in connection with the company's active at-the-market offering, will be sufficient to support ongoing operations through the end of 2026. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders. With that, I will turn the call back over to Jonathan. Jonathan?

Thank you, operator. We're now ready to take questions.

[Operator Instructions] Your first question comes from Tom Shrader with BTIG.

Congratulations on all the progress. Just an update on how you see building KETAFREE inventory? Is that something you will wait to do? You will do externally? Or do you have a lot already? And then you're quoting the generic value of ketamine. Do you think if you have -- I mean, I guess, how confident are you that if you had the only available ketamine that maybe the current generic price isn't so relevant. And how much increase in price do you think the market would bear. And then I have a DCS follow-up.

Thank you, Dr. Shrader. You always ask wonderful questions. As far as inventory goes, as I said earlier, we've already manufactured 3 registration batches. Those batches are in the warehouse. KETAFREE is up on what's called a blow-fill seal assembly line. So for those of you who don't deal with pharma manufacturing every day, most injectable drugs are sold in glass bottles. To do that, you have to actually buy glass bottles somewhere. You have to clean them, sterilize them, fill them, put a stopper and put a crimp on. Both those seal works very differently. You take a hopper full of polyethylene pellets, you melt them down into molten polyethylene. You blow them with air into the shape of a vial, the machine fills that vial automatically seals that vial with a little more polyethylene, puts a wrapper on it, puts it in a box, puts it on the pallet all without any human being touching it. You can make 1 million units of drug in the same time and at about half the cost as you can make 10,000 vials of traditional glass-filled injectable product. So we've just asked our manufacturer to do a first production run, we anticipate having a couple of hundred thousand units in the warehouse at the time of generic approval. With regard to the effect of having the only preservative-free ketamine on the market, should the citizen petition be granted, probably Wall Street analysts will do a much better job of projecting what that might do to pricing models than we can. But I agree with you that if it's a product the market wants, the market will probably pay for it.

Great. And then a quick question on the extended release D-cycloserine. Is there -- is it known that, that would have the same effect? Is there a clinical data that you don't need the spike? Or do you think you have a little clinical work to do?

I think that, that's work that can be done in vitro. Really, what we're looking for is a neuroplastic effect from D-cycloserine and there's a lot of reason to believe that continued exposure of the neurons to the drug is what matters. But we have the ability in brain slices to look at the dendritic sprouting and to look at the effects. In general, you do want a steady state of drug to create a biological response. But I agree with you, it's certainly something worth continuing to look at. And as you know, from Dr. Brown's resume, he's probably done more of this than anybody in academia.

Your next question comes from Patrick Trucchio with H.C. Wainwright.

Congrats on the progress. Just a couple of questions on each program. Just first on NRX-100. I was just wondering if you can talk a little bit more about the Type C meeting with the FDA and how that now enables an NDA filing for NRX-100 without additional clinical trials? And specifically, how is the FDA viewing the role of the 65,000 to 70,000 patient real-world data set in this submission? And then separately from that, as we think about the broader treatment-resistant depression label, how should we think about the expansion of the addressable patient population impact on payer coverage and prescriber adoption if approved?

So to start with the Type C meeting, the most important way it enables FDA review of existing clinical trials data and real-world data without the need for additional clinical trials is that that's what the FDA told us. They did not demand additional clinical trials as a precondition to reviewing an NDA filing. And when you look at the data available, there are now multiple clinical trials that have demonstrated that intravenous ketamine is far superior to placebo, far superior to active placebo and noninferior on efficacy to electroshock therapy. But of course, there's a huge safety difference between NRX-100 between ketamine and electroshock in that the electroshock group had 30% memory loss, whereas memory loss was not seen in the ketamine group. So while technically, you would say it's not inferior because the design was noninferiority based on the MADRS scale. From a patient's perspective, it's a far superior treatment. Do me in favor and restate your second question?

Yes. Just on the broader treatment-resistant depression label, how should we think about the expansion of the addressable population and the impact on payer coverage and prescriber adoption if the drug is approved?

Well, if you look at the narrower indication, we were originally forecasting which would have been people with active suicidality. That would have been about 3 million, 3.5 million patients a year reporting to CDC numbers. But if you look at the much broader population of people with depression who may from time to time have suicidal ideation, the CDC numbers would suggest that you're talking about an addressable population of 12 million or so people. In terms of payer coverage. Payers have told us in the past that as long as our course of treatment is less than about $10,000 a year, it's unlikely to have substantial formulary restrictions. Mental health is one of the most rapidly growing challenges that payers face in insurance coverage and a treatment that has the potential to rapidly stabilize people, keep them out of the hospital, keep them at work, keep them productive is highly attractive to payers. And you've seen that with SPRAVATO, you've seen SPRAVATO rapidly grow to what's estimated at a $2 billion market today. And that's the market that we would seek to share if NRX-100 is approved as we've expected.

Right. And with the ANDA showing favorable preliminary bioequivalent determination, I'm wondering what remains before final approval in the third quarter of this year?

Well, the Office of Generic Drugs has to do its process. They're going to continue to examine our stability data. They'll have to do a pre-approval plant inspection. They'll have to go through the whole litany of final checks associated with any drug approval. But we think clearing the bioequivalence hurdle is a major turning point.

[Operator Instructions] Your next question comes from Edward Woo with Ascendiant Capital.

Congratulations on all the progress as well. Assuming that you get the approval for the ANDA in Q3 2026, can you talk a little bit about your commercial strategy and how you expect to commercialize it?

Well, there are 2 large segments of buyers for ketamine under the existing label. One is hospital surgery centers, et cetera, that already buy ketamine and then there are the clinics who are using it for psychiatry for pain control, et cetera. On the former side, we've been approached by a number of organizations that already sell to those hospitals. Their names are well known and anybody who's currently selling into that marketplace is interested in a modern preservative-free presentation. So we'd be unlikely to build our own sales force to go into hospitals because the average person selling injectable drugs into a hospital is representing a number of drugs, not just one. On the other hand, the clinics that use ketamine are much smaller number. They're well known, they tend to belong to the same associations, and we do expect to set up a medical liaison service relatively small number of representatives can cover a large swath of the clinics. So we believe that it's a very compact commercial footprint, one that's easily financeable within our available resources.

There are no further questions at this time. I will now turn the call over to Jonathan for closing remarks.

Thank you. So thank you for joining our call today. As you can see, we've made progress towards 3 potential drug approvals in the near term. And we have this new pipeline target that could be a much larger use for NRX-101 than we ever anticipated. With the continuing development of the HOPE Therapeutics network for care delivery, we believe that we've really taken transformative steps to turn NRx Pharmaceuticals into a commercial stage company that has the potential to save lives on a daily basis and to bring a return to our investors. We finally reached that long-awaited inflection point where we're generating revenue, we expect to increase revenue and we really appreciate the extraordinary dedication and hard work of our team to support that long-term initiative and the patience of our investors and the support of our investors while we've made that turn. Our goal of bringing hope to life is closer than ever. Thank you so much for participating.

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