NRXP

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals first quarter 2026 earnings conference call. At this time, all lines are in listen-only mode. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference call over to Brian Korb from Astr Partners. Please go ahead.

Thank you, operator, 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 statement under U.S. Federal Securities law. 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. 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-Q, which may be accessed from the investor page of the NRx Pharmaceuticals website.

Joining me on today's call is Dr. Jonathan Javitt, our Founder, Chairman, and CEO, and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of the company's progress during the first quarter, following which Mike will review our financial results. Following our prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan, please go ahead.

Thank you, Brian. Good morning, everyone. Thank you for joining us. The first quarter of 2026 was a productive one for NRx. We made progress on both regulatory pathways for preservative-free ketamine, initiated commercial manufacturing, advanced NRX-101 into a registrational trial, continued to grow the HOPE Therapeutics network, acquired the GeNeuro assets. A year ago, we had not yet filed for our first drug approval, and we were $8.7 million in debt. Now we are debt free. We have sufficient cash for our immediate operating needs, and we've raised $7 million since the end of the quarter. We've reduced our financial statement loss by 74% year-over-year. Let me start with KETAFREE. As we reported in March, FDA notified us of a preliminary determination of bioequivalence to the reference branded drug, Ketalar.

Since then, we've continued to clear the remaining review disciplines. In April, FDA issued a labeling letter requesting only minor formatting changes and a positive discipline review letter on quality, requesting only administrative changes that FDA itself identified as minor. Leadership of the FDA Office of Generic Drugs expressed support for addressing the remaining items within the current review cycle, consistent with our summer 2026 goal. We are at the verge of entering a robust market where ketamine is in drug shortage at the exact moment when reliability matters most, and we're positioned to deliver it. From our perspective, the market shortage of ketamine is larger than is apparent from hospital data because the rapidly growing ketamine clinic market segment is frequently unable to obtain ketamine through the commercial supply chain and must rely on compounding pharmacies.

FDA has now reclassified our manufacturing site to VAI status consistent with the launch of an ANDA drug. On May 5, we transmitted our first commercial manufacturing order at the one million unit per batch scale. The blow-fill-seal process we're using delivers more than tenfold throughput compared to traditional glass vial techniques and is readily scalable at substantially lower manufacturing cost. Simply put, the most expensive component in traditional manufactured ketamine is the glass vial. With blow-fill-seal or BFS, there is no glass vial, no rubber stopper, and we calculate that we are capable of manufacturing one million units per week. Timing matters here. As of April, Sterlin's Revenna ketamine remains on the ASHP National Drug Shortage database.

KETAFREE will be the first U.S. manufactured preservative-free ketamine, free of benzethonium chloride, a preservative that is not generally recognized as safe and is no longer permitted even in hand cleansers and topical antiseptics. To prepare for launch, in April, we appointed Glenn Tyson as our first Chief Commercial Officer. Glenn brings 25 years of commercial leadership at GSK and Indivior, where he led the successful launch of SUBLOCADE. Glenn is in the process of bringing on his launch team of accomplished pharmaceutical executives, and we look forward to introducing them to you in the near future. As we prepare for anticipated approval of our preservative-free ketamine, we're entering a market that is already well established but structurally undersupplied. Sterile ketamine has remained on national drug shortage listings, as we mentioned, with intermittent back orders, product discontinuations, and inconsistent availability across hospital and outpatient settings.

At the same time, clinical demand continues to expand across both anesthesia and psychiatric use, supported by widespread off-label adoption and established infusion infrastructure. It's important to recognize that ketamine is rapidly becoming a substitute for opioids in many pain control protocols. Federal law is increasingly discouraging the use of opioids as a state law. We believe this creates a highly attractive initial commercial opportunity where reliability of supply and quality of manufacturing are as important as price. With U.S.-based production, scalable manufacturing capability, and a preservative-free profile, our goal is to provide a consistent and trusted source of ketamine at a time when clinicians are actively seeking alternatives to constrained supply on one hand and alternatives to using opioids on the other.

We believe our product represents the first domestically manufactured source of preservative-free ketamine, and we further reinforce this position through our previously filed citizen petition supporting standards for preservative-free formulations. Turning to NRX-100, as we shared in March, our Type C meeting with the leadership of the FDA Division of Psychiatry Products and the Center for Drug Evaluation and Research confirmed FDA's willingness to review existing clinical trial data together with real-world evidence as potential basis for approval without a requirement for additional trials. The NDA, which we expect to file in the second quarter, will be supported by clinical trial data on more than 1,000 patients and real-world evidence on more than 65,000 patients through our partnership with Osmind.

FDA also guided us to seek the broader indication of depression in patients who may have suicidality rather than simply seeking an approval for patients who have suicidality, which applies to more than 10 million Americans. In April, the regulatory environment evolved further. On April 18th, President Trump signed an executive order titled Accelerating Medical Treatments for Serious Mental Illness, directing acceleration of approval pathways for psychedelic medicines to treat depression, PTSD, and suicidality, and directing FDA to award Commissioner's National Priority Vouchers to qualifying drugs. The presidential order specifically directs the use of real-world evidence in the approval process for this class of drugs. Congressional appropriations language has similarly been filed, encouraging the use of real-world evidence in approval of drugs for suicidal depression and PTSD. We've applied for Commissioner's National Priority Voucher in support of our NDA.

For context, the current generic ketamine market exceeds $750 million per year, not counting the shadow market of ketamine that's being bought through compounding pharmacies, while SPRAVATO generates approximately $2 billion annually, despite labeling that does not include reduction of suicidality. Moving to NRX-101. When we advanced two parallel tracks. In our original indication of suicidal bipolar depression, we've initiated an NDA filing with submission of module three manufacturing files, and we're requesting rolling review under our breakthrough therapy designation. Separately, however, on May 7, we received FDA clearance to proceed with the MIND1 trial, a phase II-B/III study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated one-day protocol.

The trial is designed to enroll 400 participants across a leading academic teaching hospital, HOPE Therapeutics clinics, and U.S. military treatment facilities with non-dilutive federal funding anticipated. This use of NRX-101 was not anticipated until recent data have shown a doubling of clinical response and an eight-fold increase in remission from depression when D-cycloserine is added to standard transcranial magnetic stimulation therapy. The market opportunity for this indication is in excess of $1 billion. We've also achieved non-clinical validation of a proprietary extended-release form of D-cycloserine designed to support TMS augmentation. The MIND1 trial will be conducted by NRx Defense Systems, a Florida-based R&D subsidiary we incorporated in April. NRx Defense Systems is led by Dr. Dennis McBride, a retired Navy captain, a former DARPA program manager.

He served two terms as the DARPA program manager and former senior executive, both in the National Defense University and in the Office of the Secretary of Defense. The robotic-enabled TMS prototype is being developed in combination with Zeta Surgical, whose AI-powered neuronavigation platform has already received FDA 510(k) clearance for TMS navigation. We plan to unveil the prototype with Zeta at the Clinical TMS Society Annual Meeting in Boston in early June. Depression, if you want to see it, touch it, feel it firsthand, please join us. Depression and PTSD carry a five-fold increased risk in frontline troops and first responders, and personnel who are on standard antidepressants are not combat deployable. A short-term, non-disqualifying treatment is both a healthcare imperative and a force readiness priority, not only in the military setting, but in the setting of firefighters, police officers, and other first responders.

Turning to HOPE Therapeutics, we operated five Florida clinics during the quarter and expect eight or more locations by the end of the 2Q. In February, we appointed Professor Joshua Brown of Harvard/McLean as Chief Medical Innovation Officer. Joining Dr. Rebecca Cohen, our Medical Director. In March, HOPE announced a partnership with Emobot Health to deploy its AI-driven depression thermometer. That's a cell phone app that can actually measure your level of depression at a very high correlation with standard depression measures. Emobot passively analyzes facial expressions, vocal tones, and actigraphy through a background smartphone application with clinical validation showing strong concordance against both MADRS and PHQ-9. This addresses a critical blind spot in the care of patients with depression and suicidality. Approximately 50% of patients with treatment-resistant depression relapse within 6-12 months, and that relapse is often undetected between visits.

As I've said, we expect every patient in our network to be on Emobot. We continue to integrate our partnership with neurocare Group AG, which brings together the combined clinic base together with an install base of more than 400 Apollo TMS machines across the U.S. Finally, an important pipeline expansion occurred just in the past few weeks. We've just last week formed GeNeuro, Inc., a Florida-based subsidiary built around a newly acquired portfolio targeting Human Endogenous Retroviruses, or HERVs, which are implicated in schizophrenia, multiple sclerosis, ALS, autism, and optic neuritis. The portfolio was acquired through a Swiss court-supervised liquidation sale of GeNeuro, SA, a Swiss company funded with existing cash, and includes a broad patent portfolio, cell lines, antibodies, regulatory files, and data from from completed human clinical trials.

Dr. Hervé Perron, formerly Chief Scientist at GeNeuro, SA, has joined as our Chief Scientist and Professor Marion Leboyer, who joined our advisory board several years ago and whose intellectual property, whose patents led us to this portfolio, will lead the anti-HERV-W antibody program in schizophrenia. We anticipate supporting GeNeuro through non-dilutive investment channels. With that, I'll turn it over to Mike to review our financial results. Mr. Abrams.

Thank you, John. For the three months ended March 31, 2026, NRx Pharmaceuticals reported a net loss of approximately $1.4 million or $0.04 per share as compared to a net loss of approximately $5.5 million or $0.34 per share for the three months ended March 31, 2025, representing a 74% year-over-year reduction. This change is primarily related to the impact of certain fair value accounting measures and other non-recurring charges. For the three months ended March 31, 2026, NRx reported a loss from operations of $4.7 million versus a loss from operations of $3.8 million for the comparable quarter in 2025.

The change is primarily driven by certain costs related to certain, several targeted strategic initiatives advanced during the quarter ended March 31, 2026, which management believes will drive significant short and long-term value for shareholders, including but not limited to, progress toward the approval of our first drug products, allowing resources for an anticipated near-term commercial launch, augmenting and expanding profitable clinic operations, enhancing our overall intellectual property portfolio, and growing our development pipeline with new assets. For the three months ended March 31, 2026, research and development expense was approximately $1.3 million as compared to approximately $0.8 million for the three months ended March 31, 2025.

General administrative expense, which includes selling costs for the three months ended March 31, 2026, was approximately $3.8 million as compared to approximately $2.9 million for the three months ended March 31, 2025. The drivers of the changes of both research and development and G&A expense were primarily driven, as mentioned above, certain costs related to our execution towards several targeted strategic initiatives advanced during the quarter ended March 31, 2026. As of March 31, 2026, the company had approximately $6.7 million in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic revenue, ongoing cost reduction initiatives, and continued availability of the company's active at-the-market offering will be sufficient to support operations through at least 2026.

Subsequent to quarter end, the company generated approximately $7 million in gross proceeds from its at-the-market facility through the sale of common stock. With that, I turn the call back over to Jonathan.

Thank you, Mike. We made meaningful progress on each of our programs in the first quarter. KETAFREE continues to advance through final FDA review. The NRX-100 NDA is on track for submission this quarter. The MIND1 trial has FDA clearance to proceed, and we expect non-dilutive funding to support it in partnership with the military sites that plan to deploy the trial. HOPE Therapeutics continues to add clinical sites and generate revenue. GeNeuro adds a new platform for serious neurological and autoimmune disease supported through non-dilutive channels. Just to give you one example, the patent for treatment of endogenous retrovirus infection that is shown to be implicated in ALS, is co-owned with the U.S. National Institutes of Health, and the prior company had a cooperative research and development agreement with the NIH.

We're deeply grateful to our team, to our patients and their families, to our shareholders for the trust they've placed in us. Our goal of bringing hope to life is closer than ever. Operator, we're now ready to take questions.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. Should you wish to cancel your request, you may press star two. Once again, that is star one should you wish to ask a question. Your first question is from Tom Shrader from BTIG. Your line is now open.

Good morning. Congratulations on another busy quarter. Couple of operational ones for me. For KETAFREE, I understand there's need. What does the channel look like for distribution? How much do you have to build? Are the centers your customers, or will this go through larger distributors? I'm just curious how much on-the-ground work is involved here, and then I have a real-world follow-up.

Well, Thank you, Tom. You know, as always, you get right to the heart of the matter. You're describing two different channels. There's the existing hospital channel for ketamine. The reference drug is Ketalar.

Yeah.

Given the drug shortages, and what we believe will be a perception not only of quality, but U.S. manufacturing reliability, we believe that with standard locking and tackling, for lack of a better word, and as you see, the team that Glenn is bringing on to support that process in terms of payer outreach, in terms of major accounts outreach. Part of our preservative-free ketamine strategy is that traditional market. The other part is the clinic market that right now really doesn't have access to the wholesalers. We've tested this. You know, we've had our clinics call and try to buy from the wholesalers. So far, not a single one of our clinics has succeeded in obtaining a single vial of ketamine from any of the traditional wholesalers.

The wholesalers really are uninterested in the most rapidly growing area of the clinic space. Those clinics are required to rely on a web of compounding pharmacies. We intend to displace that compounded product with reliably manufactured, FDA-approved GMP product. It's a two-pronged strategy at a time when not only is the psychiatry clinic market for ketamine rapidly growing, but as opioids are increasingly restricted in their availability and their prescribability, there's an increasing reliance on ketamine to treat pain syndromes as well.

Got it. Got it. Okay. On the real-world ketamine data, I understand you have 65,000 records. What is the level of understanding with the FDA as to what they really wanna see in those records? Is that all negotiated? We have 65,000 records that show the boxes you wanna see filled, or is that a negotiation that's going? I mean, 65,000 is a lot. It's probably 60,000 more than you need if they like the records. I'm just kinda curious where that process is in agreeing on what these records need to show. Thank you.

When we say records, we say record. We mean records on 65,000 unique patients. At the risk of sounding, you know, humorous, everything with the FDA is a negotiation. You know, it's a negotiation that occurs through well-established channels. What we agreed to in our meeting with FDA was we would, you know, that they acknowledge that the preliminary cuts of the data look promising. Osmind had previously published data on about 20,000 patients, and that was part of our meeting package.

What we agreed is that we would submit a statistical analysis plan, just in the same way that one submits a statistical analysis plan for a proposed clinical trial, that before we spin the data, before we do the first analysis, we will have agreed with FDA on what statistical tests will be used, which patients will be included and excluded, how they'll be categorized, so that when we do the analysis, we're not gonna be in a position where we keep, you know, crunching the data over and over again, but, you know, sort of measure twice, cut once. Right now we're waiting for FDA's response to our statistical analysis plan. As soon as we've agreed on exactly what tests will be used, we'll apply that and submit the data.

Any time marks for any of that that you can share?

Well, there are some regulatory costs involved. We're expecting, FDA to come back to us approximately by the end of the month.

That's very useful. Thank you for all the details.

I don't wanna give you an exact date. I don't have it at my fingertips. That's about the timeframe.

Okay. Thanks.

Thank you. Your next question is from Elemer Piros Lucid Capital Markets. Your line is now open.

Yes, good morning. Jonathan, I was wondering if you could help us understand the shortage, the ketamine shortage. What are the bottlenecks there, whether it's raw material or the scale of manufacturing, and how do you plan to overcome that shortage?

Well, you know, we're not in a very good position to understand other people's products. We know there is a shortage, whether it's, you know, a lack of glass files, a lack of manufacturing capability, for whatever reason that shortage exists, all we can really do is worry about our business and make sure we can address the shortage. Do that by having a couple of years of ketamine drug ingredients in the warehouse. By having high volume assembly lines using blow-fill-seal that are capable of making a million units in a single week if you run the line around the clock. You know, by having a manufacturing partner that literally has the loading dock capacity to get the raw materials in and the finished goods out the door.

We know how to address the shortage, but I'm not sure I can tell you exactly why the supply chain is undersupplied.

Yeah. raw material doesn't seem to be an issue.

It's not an issue for us. Availability of raw material is not a problem. I can't tell you the exact situation with pharmaceutical grade glass today. I can tell you that during COVID, people were backed up a year. Pharmaceutical glass is kind of a problem worldwide.

Yeah. Somewhat related, if KETAFREE is approved, what do you anticipate the FDA's action would be towards preservative-free ketamine as the solution across the industry?

Well, I would never wanna predict what a regulatory agency will do. You know, I can say that the current secretary of health has been quite vocal in his view of the need to remove toxic preservatives from, certainly from foods, and vaccines. He's certainly not been quiet about that throughout his career. The new acting commissioner of the FDA has been quite vocal about his view of safety, and removal of toxic preservatives in various contexts. The law says that, you know, all ingredients in a drug should be safe. This particular preservative was put into ketamine back in the 1970s, and in general, you know, nobody's really looked at the formulation till we got involved.

You know, quite frankly, when we got involved, I asked, "Well, why is it there?" The answer was, "Oh, it's a necessary excipient. The ketamine will come out of solution without it." I said, "Really?" Part of the reason that happened was I was involved back in the mid-1990s. We tried to figure out why does everybody with glaucoma have dry eye syndrome. It turned out that it was the benzalkonium chloride in the eye drops that was killing the essential lipid component of human tears.

You know, that's how I first learned about this class of preservatives. You know, that's why you see preservative-free eye drops on all the drugstore shelves.

Yeah.

It'll be interesting to see how the regulatory world ultimately reacts to this. I think in general, the regulatory environment, is, you know, pro-safety and anti-preservative.

Maybe one last question. Thank you. Once you file the NRX-100 NDA, how soon do you anticipate to learn whether you got the priority review the voucher?

Yeah. Generally, that's a six-month process.

Okay.

Remember.

Thanks.

We already have fast track approved for NRX-100, so we're already entitled to priority review.

Okay. Well, thank you so much.

Thank you once again. Please press star one should you wish to ask a question. Your next question is from Patrick Trucchio from H.C. Wainwright. Your line is now open.

Thanks. Good morning and congrats on all the progress. Just first on KETAFREE, I thought you mentioned that the commercial manufacturing is now initiated at a million per dose month level. I'm wondering, you know, what inventory level do you expect to have available at the time of the launch?

Yeah, at the time of the launch, we'll have at least a million units in the warehouse, and depending on what we see between now and then, you know, we may take that up by half a million or a million units.

Got it. For NRX-100, mentioned that, you know, have fast track review, and that, you know, maybe hearing back on the CMPV could take six months. Does this imply that, you know, you might be able to get a quicker review just with the standard fast track?

I don't know if anybody knows exactly how much a CMPV speeds up the process, you know, priority review is a pretty well-established pathway, we know it does speed up the process. Could CMPV further speed the process? Could CMPV further increase the likelihood of an approval? I think those are all questions that remain to be seen. I think that the most important thing is to come to agreement with FDA on the real-world evidence, get that submitted. You know, in that regard, the president's executive order from April is enormously supportive.

You know, completely apart from the executive order from the White House, if you know, look at the appropriations language in the FDA budget appropriation for this year, you know, Congress has focused on the use of real-world evidence in the approval of drugs for depression and suicidality. I think there's an increasing recognition that this is just something that's needed for the health of the American people, and it ought to get the most serious possible and expeditious possible review.

Yeah, that makes sense. Just lastly, on the MIND1 trial for NRX-101 plus TMS, I'm wondering if you could talk a little bit more about this trial and including whether you would expect it to be registration enabling if positive.

Well, it's certainly a large enough sample that, you know, if one had a dramatically positive result and, you know, that wouldn't be p of 0.05 and, you know, p 0.01 or better. Given the priority that currently exists around treating depression and suicidality, again, back to the president's executive order, back to many things the secretary said, back to things Congress is saying, a dramatic effect in this trial on par with previous results that have been seen where D-cycloserine, you know, doubled the effect of transcranial magnetic stimulation on depression, but increased that effect more than eight-fold with respect to reducing suicidality. I think if we saw something that was as dramatic as that, the possibility of seeking an approval based on one trial would be a very real possibility.

Until the data's in hand, I'm not sure that our speculation matters. What matters is are getting this trial fielded in partnership with our military colleagues, with our academic colleagues. If you take a look at the, you know, success that Professor Brown has had in this area over the last couple of years, we're extraordinarily excited to have him as the principal investigator for this work.

Well, terrific. Thank you so much.

Thank you. There are no further questions at this time. I will now hand the call back over to Jonathan Javitt for the closing remarks.

Well, thank you. As I hope you can tell, this has been a quarter of, you know, heads down work. Our team has grown. Our proximity to market, we believe, has substantially increased or got shorter, to be precise. We're incredibly grateful to the investors who've come on board, who've lent their support, and given us their confidence. Thank you very much, and we look forward to seeing you soon.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.

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.

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