NRXP - NASDAQ

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 review the file. Last week, we were notified by FDA of a preliminary determination of bioequivalence to the reference branded drug, which is Ketalar. This is a key determination in any generic application. Our room temperature stability data has continued to support at least 3 years of room temperature stability. And we've manufactured 3 registration batches of KETAFREE in anticipation of summer 2025 approval -- 2026 approval. The company has additionally submitted a citizen petition seeking to have benzethonium chloride, a toxic preservative included in all currently approved ketamine products and it's really in there for antiquated reason, we've petitioned to have it removed from all presentations of ketamine. The FDA has just notified us that their review of expectation is ongoing. This preservative is the subject of a detailed toxicology report that we posted on the public record, which casts a considerable doubt on the assumed safety of this chemical including potential cytotoxicity and neurotoxicity. Notably, benzethonium chloride is not categorized by FDA as GRAS or generally recognized as safe. And the law requires that all ingredients of drugs must be safe. This report has been submitted to FDA in support of our citizen petition. As a preservative-free version of ketamine is an important invention, we filed a patent application with USPTO to protect our intellectual properties surrounding this product. The existing market for Ketamine has been projected at approximately $750 million a year, and we believe KETAFREE made in the United States and offered without any toxic preservatives offers patients and clinicians a superior option. As you know, we're also pursuing an innovative new drug application under FDA Fast Track Designation for Ketamine, which we've designated NRX-100. When we met with you in Q4, our intent was to submit this NDA based only on data from existing clinical trials which we've summarized for you in the 10-K and various other presentations. However, in Q4, FDA announced a significant policy change for the first time inviting companies to submit real-world evidence and supportive effectiveness without a requirement that the evidence submitted be personally identifiable. In our estimate, this provided an important opportunity to strengthen our case for approval and to substantially broaden the indication we were seeking, whereas we originally anticipated seeking only accelerated approval as we shared with you at the time, the FDA policy change to open the path to seek full approval. Accordingly, we partnered with Osmind Inc. to leverage their database on more than 65,000 patients treated with intravenous ketamine, and approximately 6,000 patients treated with intranasal ketamine. Summary data are presented in the 10-K and demonstrate the benefits that thousands of Americans have already received in reducing depression and suicidality with intravenous ketamine. As we shared with you, we were granted an in-person meeting at FDA headquarters with the leadership of the FDA Division of Psychiatry Products, the Office of Neurosciences and the leadership of the FDA Center for Drug Evaluation research. The minutes of that meeting demonstrate FDA's willingness to review not only the clinical trials data, but also the real-world evidence. More importantly, FDA guided us to seek full approval rather than accelerated approval and to seek a substantially larger indication for depression in patients who may have suicidality rather than only those who already have suicidality, an indication that we believe applies to more than 10 million Americans. Our aim is to package the data FDA have requested by the end of Q2 with the potential for decision date otherwise known as a PDUFA date by the end of the year or in the opening months of 2027. We're confident that seeking FDA's alignment on this expanded pathway was the right thing to do for our patients and our shareholders. As we shared last year, the product is already manufactured. The manufacturing modules are complete and already in the hands of the FDA and 3 registration batches are manufactured and in the warehouse in anticipation of approval. Again, we have stability data to support at least 3 years of room temperature shelf stability. In August 2025, FDA granted us an expanded Fast Track designation for NRX-100. This expanded designation goes beyond the prior grant simply for suicidal bipolar depression to now include all patients with suicidal ideation in depression including bipolar depression. Suicidal depression is a massive problem in the United States. In fact, the Center for Disease Control estimates that nearly 13 million Americans seriously consider suicide each year and this leads to an American dying from suicide every 11 minutes. In June, the FDA created the Commission's National Priority Voucher program that affords substantially faster review times of once 2 months versus the standard 10- to 12-month review, enhances communication throughout the review process and creates potential for accelerated approval, and full approval of NRX-100. The first 2 tranches of vouchers have been granted. We remain optimistic for NRX-100's chance to receive a voucher, given that CMS targeted drugs other than bulk ketamine, have been underrepresented to this point. Further, we're confident that NRX-100 meets the program's criteria and is a prime candidate to receive a voucher. Moving on from ketamine. We've experienced what we believe to be transformative change in our NRX-101 program. As you know, we originally developed NRX-101, a fixed-dose combination of D-cycloserine and lurasidone to address the needs of patients with suicidal bipolar depression. While we hope to get back into the clinic with a pivotal trial to prove the value of NRX-101 at high doses to treat patients with that condition. A near-term opportunity appeared that offers a far broader potential application for D-cycloserine the active ingredient of NRX-101. As we illustrated in the 10-K, there's a rapidly emerging body of evidence suggesting that D-cycloserine or DCS at low doses has the potential to drive neuroplasticity which is the process by which brain cells form connections to other brain cells and especially to augment the clinical effect of transcranial magnetic stimulation or TMS. Accordingly, we appointed Professor Joshua Brown, MD PhD of Harvard McLean as our Chief Medical Innovation Officer. Dr. Brown is a principal investigator on NIH funded and DARPA-funded projects that highlight the future of neuroplastic care including the use of D-cycloserine and transcranial magnetic stimulation or TMS, for treating depression, PTSD and suicidality. Today, we're announcing that we're on the path to developing a patentable sustained release presentation of D-cycloserine to provide an extended release profile suitable for enhancement of TMS efficacy. Prior clinical trials have shown a doubling of clinical response in patients with depression and an eightfold increase in remission from depression versus standard TMS therapy. However, DCS, D-cycloserine, which is a tuberculosis drug has always been a somewhat unstable and problematic molecule that degrades rapidly, if not carefully formulated and it is stable in our current formulation. Moreover, its absorption profile in the human body more closely resembles a sharp spike rather than a steady state. We're excited that after a long period of research and development, we found a path to an innovative modern version of DCS that is better suited to maintaining a steady state in the blood during TMS treatment. NRx has more than 25,000 manufactured doses of NRX-101 at the appropriate strength and has launched a nationwide expanded access program to enable physicians who are performing TMS and want to add the benefit of D-cycloserine to access this medication at no charge to the patient under expanded access and federal right to try laws while we await a confirmatory Phase III trial of NRX-101 to augment the effects of TMS. That trial is planned to start this summer, and we expect non-dilutive federal sources to support that trial. The market estimate for this newly validated indication for NRX-101 is in excess of $1 billion. We're collaborating with Dr. Brown and his DARPA-funded initiatives related to D-cycloserine and TMS that have attractive support because of the clear implications for supporting the needs of military personnel, veterans and first responders in addition to the tens of millions of civilians who need this treatment. In recent months, we've had the opportunity to brief on these activities at senior-most levels within the Department of War, the Department of Veterans Affairs and both House and Senate leadership who are concerned about the welfare of our troops and veterans. That's why some of you noticed my attendance in the gallery at this year's State of the Union address. Our clinics have contracts to treat military personnel through TRICARE and to treat veterans through direct contracts with the VA. We first established a cooperative research and development agreement with the VA in 2018. In September 2025, HOPE Therapeutics initiated revenue generation upon closing its first acquisition of Dura Medical located in Naples and Fort Myers, Florida. HOPE subsequently added Cohen & Associates in Sarasota, another revenue-generating site, an EBITDA-positive clinic that's now part of our HOPE network. Dr. Rebecca Cohen, Founder of Cohen Associates has been appointed as HOPE Medical Director. In December, HOPE was the first organization in Florida to launch 1-day TMS treatment for severe depression combining D-cycloserine and TMS. The 1D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression in 6 weeks following a single day of TMS treatment combined with D-cycloserine. By way of comparison, if you look at the SPECT-D trial, antidepressants have been reported only to demonstrate about half that response. We're currently opening additional clinics in West Palm Beach, Sarasota, Boston, Denver, with the expectation that we'll have a far more robust network by the end of the year with revenue to match. Although there are many more milestones described in our 10-K, I'll end with our newly declared partnership with Neurocare AG of Munich and Atlanta, Georgia. Neurocare manufactures the top-selling TMS device in the U.S. today, the Apollo machine, which has installed at more than 400 clinical locations in the U.S. with many more internationally. Our aim is to leverage our mutual strengths to achieve the benefits of integrated care in neuroplastic integrated psychiatry that were achieved in renal dialysis through integration. Those results were achieved several decades ago by DaVita and Fresenius Medical. Those 2 organizations demonstrated that combining integrated pharmaceutical and medical device development with a quality-driven approach to patient care could transform clinical outcomes for patients with end-stage kidney disease, and they created organizations that are currently valued at $15 billion and $30 billion, respectively. We aim to take that same model into the future of interventional psychiatry for the treatment of PTSD, depression, autism, traumatic brain injury and Alzheimer's. Working together with our academic partners, our government partners and now with the leading medical device partner we'll do everything in our power to bring hope to life. I'll now turn it over to Michael Abrams, our CFO, to review our 2025 financial results. Mike?

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.