NRX Pharmaceuticals Inc Aktie

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals conference call to discuss the FDA approval of preservative-free ketamine. [Operator Instructions] This call is being recorded on Friday, October 30, 2026.

I would now like to turn the conference over to Brian Korb of ASTR Partners. Please go ahead.

Thank you, operator, and welcome, everyone. Before we begin, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These include statements about the timing of commercial launch and first shipments, market size and growth, pricing, manufacturing and supply and future products. These statements are subject to risks and uncertainties that could cause actual results to differ materially from the present expectations.

Additional information concerning these factors is contained in the press release issued this morning and in the company's periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of today, and the company undertakes no obligation to update or revise them. NRx is not providing revenue or margin guidance on today's call.

Joining me today is Dr. Jonathan Javitt, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals. Following his prepared remarks, we'll open the call for questions. I will now turn the call over to Jonathan. Jonathan, go ahead. Congrats.

Thank you, Brian. Good morning, everyone, and thank you for joining us. This morning, we announced that the FDA has approved our Abbreviated New Drug Application, or ANDA, for preservative-free ketamine ahead of the November 10 goal date. This is NRx's first approved product, and it marks our transition from a development stage company to a commercial company. According to the FDA's data, the average time to ANDA approval is 35.6 months. This ANDA took less than 14 months from the time of submission.

While that's in part a function of the extraordinary team who come to work with us each day and the regulatory lawyers who support us, it's also a function of the recognition that goes from the FDA all the way to the President of the precarious nature of the U.S. sterile drug supply and the urgent need to return sterile injectable drug manufacture to the United States. Today, nearly 60% of sterile injectable drugs that are critical to the lives of Americans are manufactured overseas. We've seen shocks to our energy supply, even though the United States is a net exporter of petroleum.

Imagine if we had a shock to our sterile drug supply and surgeries could not be performed for lack of anesthetics or infections could not be treated for lack of antibiotics. Although we will be talking about our first ANDA drug approval today, much of what I will say is generalizable to many drugs. Many investors in our segment don't expect biotech companies to become commercial pharmaceutical companies. However, commercial pharma is where we come from at NRx.

Our leadership team has decades of commercial experience at some of the world's largest pharmaceutical companies. One of our founding Board members, Chaim Hurvitz, rose to be President of Teva's International division and served on Teva's Board during the years when they pioneered the first treatments for multiple sclerosis and other CNS diseases.

Given the sales force resources already in place at our partner, Nephron Pharmaceuticals, we are immediately capable of meeting the market demand for our first commercial product, and we embrace the challenge. I want to use our time this morning to cover 5 things. How did we get here? And what does this have to do with our original mission? Why are we able to manufacture an old generic drug at new innovative drug margins? Why this product matters to patients and hospitals, a bit about the U.S. ketamine market and how we plan to launch. Then we'll take your questions.

So how do we get here? As those of you who have been long-term shareholders know, our company was founded around NRX-101, an oral antidepressant currently being tested in a DARPA-funded Phase 3 trial in combination with transcranial magnetic stimulation. Our original breakthrough designation from the FDA for NRX-101 called for us to stabilize suicidally depressed patients with ketamine, following which they would receive our innovative oral drug. As we discussed with shareholders a few years ago, when we met with FDA after COVID to reinitiate our psychiatry program, FDA asked us to seek a label for use of ketamine in depression.

That's when we learned how tenuous the U.S. ketamine supply is, when we learned about the benzethonium chloride problem and when we began to understand why ketamine and most of old sterile drugs like it are no longer manufactured in the United States. Most of the cost of manufacture in a sterile injectable drug is actually in the glass bottle, not in the drug. It was the combination of a worsening drug shortage for a $400 million a year U.S. product whose need is quite much larger overseas whose demand is growing rapidly, the ability to use modern blow-fill-seal manufacturing technology to make it feasible to return ketamine manufacture to the U.S. and the realization that we could remove an old toxic preservative in the process that led us to seek and obtain FDA approval to sell ketamine for the broad hospital and clinic market, not just for the psychiatry market.

This is a path that we had the experience to undertake. 30 years ago, Dr. Panicucci, our Head of Manufacture, and I were involved at different pharmaceutical companies in moving the manufacture of eye drops from preservative-containing bottles to preservative-free blow-fill-seal solutions that have now become standard. However, the solution that worked for dropper tip vials could not work for injectable products because of the need to maintain sterility while drawing the medicine into a syringe. The missing piece was the innovative luer lock tip developed by our German partners at Rommelag and pioneered at Nephron Pharmaceuticals.

Although it's a tiny bit of plastic, you have seen on the FDA website that our innovative vial is classified as a drug device combination. You saw that it took an extra 2 months to get the ANDA through as we demonstrated the integrity of that product component. The user studies we've completed with doctors, nurses and pharmacists tell us that professionals are highly enthusiastic about a medication vial that eliminates the need to affix a needle to a syringe, advance the needle through a rubber stopper of a glass vial and withdraw the medication. Not only do we cut the staff time in half and eliminate the medical waste, we end the risk of needlestick injuries because with our solution, there's no needle.

This newly developed ability to package a sterile injectable drug in a blow-fill-seal vial without the ever-increasing cost of glass bottling substantially reduces our cost of goods and enables us to manufacture and distribute an old generic drug at margins that rival the margins of new innovative drugs. Suddenly, it's economically feasible to restore sterile injectable drug manufacturing to the United States. Together with the preservative-free nature of our product, the ease of use and our ability to guarantee supply, we believe we're poised to enter the U.S. hospital and clinic supply chain and displace old generic players who cannot adequately supply quantities of badly needed drugs.

At the same time, we remain committed to obtaining an FDA label for treating depression and PTSD with ketamine and are compiling newly obtained data comparing IV ketamine to Spravato that we will share in our next quarterly earnings call. So why is there a supply shortage of ketamine? And why will it get worse without us? Ketamine for injection has been on the national drug shortage list since February 2018. According to the American Society of Health-System Pharmacists, as of this month, all 6 ketamine manufacturers have at least 1 presentation of their product back ordered, intermittent or on allocation and some manufacturers have recently discontinued production altogether.

The Secretary of Health and the FDA Commissioner have identified ketamine as a strategic drug whose supply in the United States must be assured. As I mentioned, most of today's supply comes from overseas and is made the traditional way in glass bottles. That labor-intensive process has not been economically viable in the United States for decades. We can package 1 million doses of ketamine using blow-fill-seal technology in about the same time as a glass bottling line can package 10,000 to 50,000 doses. More importantly, we don't have to buy pharmaceutical-grade glass bottles and stoppers, which are frequently in short supply and have quality problems of their own. All we need to buy is a few plastic pellets and let the machines do the rest.

Our belief is that the reason for the shortage of ketamine and other old injectable products is that manufacturing costs have risen to the point where suppliers are somewhat indifferent about supplying and are reallocating their manufacturing capacity to biologics and other high-margin products. This has created a unique commercial opportunity for us together with our partners. Preservative-free ketamine is made in West Columbia, South Carolina, by our partners at Nephron Pharmaceuticals on high-speed blow-fill-seal lines with no glass.

You might ask, why won't the rest of the world copy us? Well, certainly some will, but the innovative luer lock tip that enables the process is proprietary. The technology cost is high, the skill set required to implement the technology is higher, and we have a head start. In fact, we're in the process of taking delivery of additional manufacturing lines from Germany to meet the rapidly emerging demand. Today's approval shows that sterile injectable drugs can be brought back to the United States using modern technology for the benefit of American patients, workers and their families. The FDA's approval ahead of the goal date shows the agency's commitment to timely approval of drugs that are in critical shortage.

So why does preservative-free ketamine matter? Ketamine has been used in American hospitals since 1970. It's used primarily for anesthesia and pain control, including in labor and delivery, where it's the only IV anesthetic that minimizes suppression of breathing in the baby. Yet every ketamine injection product available in the United States today contains a preservative, mainly benzethonium chloride or BZT. BZT is there to keep multi-dose glass vials sterile. It does nothing whatsoever for the patient. The FDA has declined to designate it as Generally Recognized as Safe or GRAS, and under current FDA policy, it cannot be included in new drugs, consumer hand cleansers, wipes or health care surgical hand rubs.

Ketamine is one of the last remaining sterile drugs that still contains BZT. We filed a citizen petition asking the FDA to remove BZT from ketamine and the expert toxicology report that accompanies that petition is available for you to read on the public FDA docket. That report documents that patients receiving ketamine at doses routinely used today in hospitals and clinics may be exposed to BZT at levels that exceed the FDA's published maximum daily exposure of 1 milligram.

The concern is greatest in critical care and pain infusions, which can run 3 to 8 days and in vulnerable patient populations such as newborns, patients with anemia and patients with impaired kidney function. For decades, it was widely believed that BZT was required for the long-term stability and sterility of ketamine. We have shown otherwise. We've completed 3 process validation lots at the approved batch size, and 2 years of real-time stability data, we're about halfway to our third year, showing no less potency or sterility than day 1.

Having demonstrated this for ketamine, we're prepared to extend the technology to other sterile injectable products that could enter the market by the end of 2027. Although we remain committed to our innovative roots in treating CNS disease, we believe that the learnings from this product approval can be leveraged to other immediately marketable products that will benefit patients and drive revenue and earnings for our shareholders.

So what is the market for preservative-free ketamine? We're going to give you a lot more information about the granularity of that market when we report earnings in a few weeks. But at the current price of $5 a vial, which is what's called the MAC price, that's the price hospitals pay en masse, it's a market that approaches $400 million in 2027. That market is growing rapidly as ketamine finds more and more uses. The uses of ketamine and psychiatry today have gained a great deal of popular attention. However, psychiatry is really the tip of the iceberg.

There's a rapidly increasing use of ketamine at substantially higher doses for pain control indications that were previously treated with opioids. Hospitals are under intense regulatory and public pressure to curtail opioid use and ketamine is one of the few solutions that can give patients relief from severe pain without opioids. While the psychiatry uses remain off-label and will require us to obtain new labeling claims in order to secure insurance reimbursement and in order to promote for those indications, the pain control applications are already reimbursed by insurance. The hospital segment is growing rapidly.

In 2025, the demand for ketamine grew 17%. The demand is there. The problem has been supply. So what have the buyers told us? As we were completing the ANDA process, we spoke with hospital pharmacists, administrators, health systems and group purchasing organizations. Their message was consistent. Every GPO or group purchasing organization and every pharmacist we spoke with named supply of ketamine as a top concern. Health systems scored supply shortages at a score of 4.6 on a scale of 5. It was their top pain point. Those buyers told us that they will switch for reliable supply and simpler, safer preparation. We identified no customer allegiance to the current offshore suppliers of ketamine or other sterile injectable products.

So that brings me to the launch. Our approach is simple. First, assure supply for customers. As we previously announced, we've ordered 5 million vials as launch stock and Nephron is building that stock now through December. We expect to manufacture in million-vial batches going forward. The ketamine drug ingredient is in hand, and we've manufactured the process validation runs that prove our manufacturing capability. Now that our ANDA is approved, we are opening prelaunch orders as launch supply builds. First shipments will begin once sufficient stock is in place so that when a hospital commits to us, we can keep that hospital supplied.

In a market where every manufacturer is short of ketamine, being in stock is how a new supplier wins share. We're reaching customers through 3 channels. First, hospitals. Hospital ketamine purchasing is highly concentrated at about 17% of U.S. hospitals, perhaps 1,200 customers, many of whom are already in national buying groups, buy about 80% of hospital ketamine. Our channel account sales team is in place and focused on those hospitals. The largest accounts will receive account plans and guaranteed supply agreements, while the rest of the market will be served through wholesalers and GPO catalogs, inside sales and online ordering.

Second, trade and GPOs. We have access from day 1 through Nephron's existing wholesaler and group purchasing organization contracts. McKesson, Cardinal, Cencora carry about 90% of U.S. distribution for ketamine and Vizient, Premier and HealthTrust cover about 80% of hospital beds. In parallel, we'll pursue our own contracts. And third, clinics. We've previously shared with you our relationship with Osmind, a medical record vendor focused on interventional psychiatry. We're partnered with Osmind to bring real-world evidence on ketamine efficacy in depression to the FDA in support of our NRX-100 approval.

Together with Osmind, we built a clinic ordering platform to enable affiliated psychiatry clinics to order our product as needed with 1 click inside a system that they already use. We're also mapping the broader universe of roughly 8,000 ketamine clinics using claims, electronic health records and directory data. Our engagement with clinics is limited to the ordering process. We'll not be promoting the product off-label. This commercial infrastructure for ketamine launch is in place. Nephron runs order-to-cash, including third-party logistics, invoicing, chargeback and the data feed. IQVIA supports gross-to-net and government pricing and reporting. ProPharma handles medical information, pharmacovigilance and promotional review.

Here's how we expect the first year to unfold. Before shipments, we presell, take supply reservations and offer supply agreements to our top accounts. In the first 3 months of shipment, we focus on converting the top decile hospitals. In months 4 through 6, we widened to more hospital deciles and health systems, and group purchasing organizations, and build clinic reorders. In months 7 through 12, we deepen our share within each account.

So what comes next? Preservative-free ketamine is the first step. We plan to add a family of vials, different sizes, different strengths beginning in 2027. We'll be taking delivery of our first new manufacturing line from Germany in Q1 2027 and thank the investors led by B Group who made the manufacturing expansion possible. These time lines are planning assumptions. Each new vial sells to the same account under the same agreements and the hospital and clinic channel we are building for the preservative-free ketamine is the same channel that will carry NRX-100 if approved.

As Brian mentioned, we're not providing guidance today. For those of you who are building models, we know that the ketamine market in the U.S. alone is in the $400 million range, and we'll provide substantially more granularity when we announce earnings in a few weeks. So why should this matter to us as Americans? We've talked a great deal about why our product matters to patients, to medical professionals and families.

Let's talk for a minute about why it matters to Americans. According to the Brookings Institute and the U.S. Pharmacopeia, nearly 60% of sterile injectable drugs that treat Americans are manufactured overseas. This year, we've seen supply shocks in the energy sector, even though the United States is a net exporter of energy. Returning sterile injectable product manufacturing to the United States is not only critical to our nation's security, it has the potential to create tens of thousands of rewarding manufacturing jobs. So to summarize, every competing ketamine product contains a preservative and ours does not.

Our product is made in America. It's made at margins that rival the margins of an innovative drug, and it enters the market that has been short of supply for more than 8 years. Our launch stock is building. Our sales team is in place, and we have distribution access from day 1. I want to thank FDA's Office of Generic Drugs for its timely review, thank our partners at Nephron Pharmaceuticals, our regulatory team at Hyman, Phelps & McNamara, our employees who have been at this now for 10 years and our shareholders for their continuing support.

Operator, we're now ready to take questions.

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

Congratulations on a beautiful overview. I'm wondering if in your interactions with the FDA, you got any read on their view of the preservative. And also, similarly, you talked a little bit about copying your vial as a risk, but don't you have IP around the preservative-free form of ketamine? So how robust is that IP? And then I have a follow-up.

Well, so to take your question sort of in reverse order, yes, we have a patent filed that's in prosecution around a preservative-free formulation. I would never speculate about the robustness or the defensibility of a patent. It's important to get as much IP as we can. We also have IP around that drug device combination that represents our luer lock vial. You can't just go and make that yourself tomorrow and have it be compliant.

You saw that we got a lot of scrutiny during the ANDA process from not only the FDA Office of Generic Drugs, but the Center for Devices and Radiological Health. You saw that 2-month delay in the ANDA approval, even though we were well prepared with thousands of pages of detail around that device component. As I said, it's about 2 millimeters of plastic, but it's got as much documentation behind it as far more complex medical devices and the FDA takes it very seriously. So we have IP both around the formulation, but also around the innovative packaging that for the first time, makes it possible to distribute a sterile injectable product in a blow-fill-seal format.

Got it. Okay. And then the citizen petition and the FDA?

So the FDA has said a lot of what they think about benzethonium chloride in their public hearings. Those hearings are referenced in the citizen petition in the toxicology report. But the fact that the FDA has put benzethonium chloride clearly in its crosshairs and said you can't even put this in a hand cleanser tells you a lot about what the FDA thinks about that particular quaternary ammonium preservative. And these preservatives have uniformly been driven out of the drug supply. Ketamine was just one of these odd products that was formulated during the Vietnam War, and nobody ever really took a hard look at the formulation since.

Got it. And if I can follow up, we've often felt that the efforts to build the HOPE network would be greatly helped by unique products and it looks like you have one now and others in the pipeline. Do you think this is enough? Or do you think correctly labeled ketamine is bigger? Or just your thoughts on how this might ripple through to the HOPE side of the business because now you have a unique product that seems worth distributing?

Well, certainly, although we'll never tell the doctors in the HOPE clinics what medicines to use, we certainly hope that our doctors will want to use our medicines. But if you're looking for the unique opportunity in HOPE, I'd direct you back to the confidence that the Defense Advanced Research Projects Agency has just placed in our company, in our newly formed NRx Defense subsidiary, which is now a qualified DARPA contractor and in the role of HOPE Therapeutics.

You've got the most prestigious research organization in the U.S. military saying that if our combination approach using transcranial magnetic stimulation and NRX-101 succeeds as it already has in Phase 2 studies, this could be the standard of care for treating depression in military personnel and first responders. There's been a lot of excitement about psychedelics, but you have not seen that excitement within the mainstream military. You've not seen that excitement within first responder organizations. I think there's a certain amount of trepidation about psychedelics in those settings.

So if you're looking for where will HOPE gain a unique niche and sort of the sub-question to that, maybe why are we going a little slower than we thought we might when we founded HOPE, we believe that we're on the verge of a short treatment, maybe even as short as 1 day that gives patients benefits that previously were not achievable with oral antidepressants, previously were not achievable with ketamine alone, with ketamine nasal spray and results that exceed anything that's ever been reported for a psychedelic. So if your question is what's the unique opportunity within HOPE, the unique opportunity is to pioneer combination treatments for depression, suicide, PTSD that work for Americans.

The next question comes from Elemer Piros with Lucid Capital Markets.

You talked about 3 different channels. How do you envision the distribution or the proportion of revenue coming through these 3 channels approximately?

Yes. I think that's something that we should reserve for a fireside chat. I'd love to bring our commercial team on with you and let's really explore it. But in terms of priorities, the first priority is to take down the largest hospital buying groups first. And the key is assuring supply. This isn't really a fight about pricing. The first priority for hospital buying groups is not about preservative-free. That wasn't on their radar. The first priority is assured supply.

They need to know that when an anesthesiologist schedules surgery or schedules a pain control infusion that the ketamine is going to be in the pharmacy. And right now, you've got U.S. hospitals reaching out to compounding pharmacies to buy ketamine in emergency situations because they can't get it through the legitimate pharmaceutical supply chain. So we intend to end that problem. And if we can end that problem, we'll have a great first year.

Yes. And would you discuss pricing at this stage, cost of goods and how revenue is going to be recognized? And what is going to be the split between you and Nephron when Nephron is involved?

Well, we have a supply agreement with Nephron that provides a highly attractive cost of goods. For today, we'll say that our margins rival the margins that people see with some of the innovative drugs today. By the time you bought a glass bottle in Asia, wash the bottle, fill the bottle with drug, put a stopper on, crimp cap, got it in the box, got it on a ship, got it through customs, your cost of goods doesn't leave you a whole lot of margin. And we think that, that's part of the reason for the supply shortage.

Anybody who took Econ 101 in college says that suppliers will supply up to their point of indifference. And at the current hospital prices, I think we're seeing transient economics play out. All of a sudden, we have an opportunity through a technology shift. And as I said to Tom, some of that is proprietary. Somebody can't go out and start selling a luer lock vial tomorrow. We have an opportunity through a technology shift to restore the margin to the manufacturing process and make it really worthwhile for ourselves and our shareholders to commit capital to this and expect to have a profitable company.

Right. How large is the sales team that you described, Jonathan, that would be serving the hospital market?

It's certainly in double digits. People are being hired every day. So I don't want to give you a precise number. But it's more than adequate to immediately address 80% of the hospital demand.

Okay. And my last question is, what do you think the time line for resolution of your citizen petition? And maybe part B to this, how would your pricing power change if it is decided in your favor?

There's no PDUFA clock or GDUFA clock on a citizen petition. At the same time, you're seeing an administration that is on the record, highly opposed to toxic preservatives. One of the leading voices in the administration on the MAHA side who's been vocal about toxic preservatives is the person who's now awaiting final confirmation as Commissioner of the FDA. So there's probably never been a more receptive environment within the Department of Health and Human Services to take these old toxic preservatives out of foods and drugs. I can't tell you what the timing will be. I can tell you that we're meeting with people every week. The election has got people a little bit distracted, but people are going to be back to work next week.

The next question comes from Patrick Trucchio with Wainwright.

Congrats on the approval. Jonathan, just stepping back, what do you think investors should understand differently about NRx now that you have your first approved product? And what would you most like to demonstrate over the next year to establish NRx as a commercial pharmaceutical company?

Well, I think your question contains the answer. What do we want people to think about us? We want people to think that we're not a binary biotech company that's going to live or die on its first approval and then sell that product off to big pharma, we want people to recognize that they're seeing an emerging U.S. pharmaceutical company that's committed to U.S. manufacture of innovative products. And although technically, ketamine is a generic product, we're bringing it forward using innovative technology that restores the margin to it and makes it a viable product to be sold aggressively within the U.S. marketplace.

So I think our investors will increasingly have exposure to the commercial side of the company, to the talent that we've recruited. Recognize that Dr. Panicucci spent 25 years at Novartis before building the global footprint for WuXi AppTec before going to BridgeBio and bringing a number of highly innovative products into the marketplace. Mr. Tyson has experience at former CNS-focused commercial companies where sales records were beaten on a regular basis. And as I explained to you earlier, we start out with a founding shareholder and Board member who was one of the leaders of Teva. So I think that now that we've finally demonstrated the ability to get approval and to get it done in about 1/3 of the time as the FDA says is average, we've started to demonstrate some credibility to be thought of as a pharmaceutical company.

Right. That's helpful. And then as the ketamine as the sort of the supply builds over time, what do you believe will be the most durable reason hospitals and clinics choose NRx? And how do you turn that initial adoption into a lasting franchise?

All of these sterile injectable products have tenuous supply chains. And the answer is supply. If we can get face-to-face with a hospital purchasing agent and show that we're making these drugs in the United States, they don't ever have to worry about a container being stuck somewhere between China and Hoboken, New Jersey. If we can demonstrate assured supply, we can win. And the rest is upside. The preservative-free is attractive. That's going to take some education of the market. The blow-fill-seal and needle-free use of the vial is attractive to the professionals who have been in our user tests. And we think that, that will drive appreciation of the market. But first and foremost, our customers care about our being able to assure supply.

Yes. That's helpful. And you described an opportunity to extend this manufacturing approach beyond ketamine. I'm wondering how you would decide which opportunities to pursue? And how could it sort of relate back to the core CNS programs?

The additional sterile injectable drugs that we add to this program may not be CNS focused. We'll be looking at where is the greatest market need, where is our ability to serve a drug shortage market with U.S. manufactured goods and assured supply. And the revenues from that will certainly enable us to do more and more innovative work on the CNS side. And that's kind of what you saw happen at Teva. You had a very successful generics organization that basically provided the capital that was needed to market the first drug for multiple sclerosis.

So we didn't found the company ever expecting to get into the sterile drug marketplace. That happened because FDA surprised us and said, "Hey, guys, you got to get a label on ketamine if you're going to use it to treat depression." And we said, well, if we're going to sell ketamine, we better sell ketamine to a much broader marketplace than the psychiatry market because otherwise, it's not financially feasible. So we made that bet. The B Group and other investors got behind us. And at least today, it feels like that bet is paying off.

The next question is from Ed Woo from Ascendiant Capital.

Yes. Congratulations on the approval. As you begin to roll out into the U.S. market, is there any opportunity in international for you to take your expertise and to apply it elsewhere?

Are you asking, can we sell this drug into Europe? Can we sell this drug into the APAC region?

Yes, or North America, Canada?

Yes. But remember, the Canadian market is not all that large. I think as we look across the borders, there's extensive opportunity because pharmaceutical glass continues to get more expensive as labor costs in other markets rise, the labor intensiveness of glass bottling continues to get more expensive. So you're going to see more and more suppliers exiting the market for these old sterile products and more opportunity for us to become a net exporter of sterile injectable drugs.

We've been on this for 45 minutes. It's been wonderful to have a chance to catch up with you. We're going to be reporting earnings in a few weeks, and I'm sure we'll see a number of you back again. If you have things that you'd like us to address in that earnings call, please let Brian know. And thank you, and have a great day.

Thank you, Jonathan.

Ladies and gentlemen, this concludes the conference call for today. Thank you for your participation. You may now disconnect your lines.

Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Second Quarter 2026 Results Conference Call. [Operator Instructions].

I would now like to turn the conference call over to Sebastian Gomez of 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 statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

The forward-looking statements 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-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 both the first half of the year and second quarter in particular, following which Michael Abrams will review our financial results. Following their prepared remarks, we will address investor questions.

I will now turn the call over to Jonathan. Jonathan?

Thank you, Sebastian. Good morning, everyone. Thank you for joining us. The second quarter of 2026, was a major inflection point for our company across multiple key objectives as we advanced our mission to bring hope to valuable patients battling depression and suicidal ideation. We continue to drive forward toward those key objectives with quarterly results that include completing the first cycle of a review of our ANDA for preservative-free ketamine with only a single remaining major deficiency to resolve with FDA, advancing the path to approval for NRX-100, supported by White House and Congress guidance to the FDA for the use of real-world evidence to establish comparable or superior efficacy working in concert with the U.S. military as the prime contractor that's been identified for the SPARC-TMS trial. That's an FDA-approved Phase II/III trial of NRX-101 with robotic TMS that we expect will include 240 patients in our HOPE clinics and at Harvard/McLean together with another 160 patients at military treatment facilities all funded through the military. And we're still in the contracting process for that. Completing the acquisition of the general assets and the resulting partnership with NIH, to potentially develop the first disease-modifying drug to treat ALS and finally, continuing growth and development at the HOPE Therapeutics clinic footprint with expanded operations in Florida.

Let me start with the ANDA for preservative-free ketamine. As we discussed on our August 10 conference call, the FDA identified no major deficiencies related to the drug or with manufacturer. A single major deficiency was identified, however, related to the Luer lock component of the vial, that's the little prongs on the tip of the vial that connects the vial to a syringe without having to use a needle. And FDA requested that the company provider manufactures attestation that the vials manufactured in the same manner as it is for 3 other currently approved drugs have shipped more than 12 million units a year. This attestation has been provided to the FDA and the company aims for 2026 approval. Accordingly, 5 million units of launch stock have been ordered from the manufacturer.

Turning to NRX-100. We've continued to advance that new drug application to treat depression. During the second quarter, our presidential executive order was signed by President Trump and congressional budget language was added by the Agricultural Appropriations Committee of the U.S. Congress as the committee that funds the FDA. In both cases, guiding the FDA to use real-world evidence for approval of ketamine and other psychedelic products to treat depression.

Evidence gathered from 65,000 Americans was presented at the American Society of Clinical Psychopharmacology meeting in Miami this year, demonstrating that intravenous ketamine, has greater or comparable efficacy to Intranasal S-ketamine with more rapid onset in treating depression. With alignments on the drug vial that's used both in this product and the ANDA product, the company is now poised to finalize its NDA, also aiming for 2027 approval.

Turning to NRX-101, we're delighted to announce a positive and meaningful potential expansion of the market for this drug. As you know, we began working on this drug as an oral antidepressant for the treatment of bipolar depression. However, data began to emerge that the D-cycloserine component of our drug, not only had the potential to augment the effects of transcranial magnetic stimulation or TMS, perhaps doubling or tripling that effect in randomized prospective trials.

More recently, research partners at Harvard/McLean have seen evidence that the lurasidone component of our drug is independently beneficial. The military has gotten involved in the implications of this research because military personnel were required to take chronic antidepressants are not deployable. That's also true of first responders. A firefighter who takes SSRIs is off the truck. A police officer who takes SSRIs is generally forced to surrender a badge and a gun. At the extreme end, a pilot on antidepressants is grounded for 5 years. Now, TMS plus NRX-101 potentially opens the door to a short-term effective treatment with long-lasting effects that can put a sailor back on a ship or a firefighter back on the truck.

Now as you know, DARPA, the Defense Advanced Research Projects Agency as DoD's most advanced research organization rarely does medical research. They are the people who invented the Internet, invented military simulation who invented swarming drone technology and a host of our most critical forward-looking technology.

In this case, however, managing depression of PTSD has become such a key issue for force readiness and the readiness of first responders, the health of veterans and the general population that DARPA did get involved. The SPARC-TMS trial that you can read about on clinicaltrials.gov is a continuation of Phase I and Phase II research that was funded by DARPA at Harvard/McLean that showed extremely promising results.

So in a potentially federally funded expansion of our business plan for NRX-101, that is D-cycloserine and lurasidone, we were selected as a prime contractor by the Defense Advanced Research Projects Agency, and we're currently in that contract negotiation process to lead the SPARC-TMS trial led by Professor Josh Brown that will combine NRX-101 with robotic-driven TMS. Our partners include Harvard/McLean Hospital and multiple U.S. military treatment facilities, including the flagship Walter Reed National Military Medical Center.

rTMS measures the efficacy of our neuroplastic drug in combination with robotic-assisted TMS. Successful clinical results could lead to widespread adoption of this drug with robotic TMS for treatment of depression in the military and first responder organizations and in the general population. With initially published results that have rivaled or exceeded the results achieved with psychedelic drugs, the idea of fixing your robotic arm to a transcranial magnetic stimulation coil and combining that with precise neuronavigation maybe surprising to many who assumed that all TMS is basically alike.

Our belief, however, and it's a belief that supported by the published literature is that traditional TMS is 2 technician dependents and the failure of some clinics may have been tied to human technicians who aim the coil based on basic anatomic guidelines. The technology that will be tested in the SPARC trial locates the depression focus in the brain using functional magnetic resonance imaging and then treats that area with sub-millimeter precision. The NRX-101 component of the treatment creates a neuroplastic environment that, at least in small peer-reviewed studies, has doubled or tripled the effect of TMS.

Until now, NRX-101 was positioned only for the treatment of suicidal bipolar depression, a separate inpatient market. This military partnered and FDA-approved Phase III trial, potentially expands the market for NRX-101 to all patients with treatment-resistant depression with an addressable market of more than 15 million Americans. You can see more about this on our website, nrxdefense.com.

Our HOPE Therapeutics network has continued to expand, and we now have 5 clinical locations in Florida. With the likelihood of expanding more broadly as opportunities to fold in partner clinics that share our philosophy are identified. The SPARC-TMS trial and the technologies we're embracing in that process, provides HOPE Therapeutics a unique platform from which to take a stand on technology, clinical excellence and the highest standards of compassionate care. Our focus on neuronavigation, on robotic TMS and neuroplastic-assisted care is not today the mainstream focus for people who get TMS. However, we expect to show that it produces a superior result in a shorter time frame than traditional handheld TMS.

Finally, GeNeuro, a word that's new to many of you, is the culmination of 3 years of work and the potential beginning of a breathtaking paradigm-changing but longer-term opportunity. The project began with the partnership we established and announced several years ago with the Fondation FondaMental in Paris chaired at the time by David de Rothschild and led by our colleague and Advisory Board member, Professor Marion Leboyer. And their work that demonstrated the role of human endogenous retroviral proteins, specifically HERV-W in causing psychosis in both schizophrenia and bipolar disorder.

Now most of you have probably never heard of human endogenous retroviruses. When I got my molecular biology degree in 1978, they taught me that 8% of the human genome was junk DNA. Now we know that 8% of the human genome are old fossilized viruses that crept into humanity over the last 3 to 5 million years. And for the most part, they just sit dormant. But when they start expressing proteins, they're no longer capable of becoming competent viruses, but when they start expressing proteins, some of those proteins are exquisitely neurotoxic. You can read about the work, read about the patents that GeNeuro now owns on the geneuro.us website.

Over time, as we learn more of the roles of these fossilized viruses that appear in the DNA of every human today, it made sense to acquire the entire portfolio of patents, cell lines and human stage drugs, an acquisition that was finalized in June by the Swiss courts. The GeNeuro now owns 2 clinical stage monoclonal antibody drugs, one to treat ALS, that's called GNK-301 and another temelimab so far has shown meaningful effects in multiple sclerosis and type 1 diabetes, and in Professor Leboyer's work, may well have an important role to play in the treatment of schizophrenia and other forms of psychosis.

So it's been shown that perhaps as many as 50% of patients who come into French and German psychiatric hospitals with acute psychosis have the HERV-W envelope protein in the blood and in their CSF. And at least in animal models, it's been shown that the psychosis induced by HERV-W envelope protein actually reduces the psychogenic effect.

Now the work that's been done was done by the Fondation FondaMental in Paris with French government funding, and GeNeuro aims to partner with them to launch a clinical trial of temelimab to treat schizophrenia. GNK-301 is a very different story, whereas HERV-W is associated with the diseases I just discussed, human endogenous retrovirus K has an envelope protein that's found in the vast majority of patients with ALS with the sporadic form of ALS, not the people with genetically induced ALS.

And this drug, which is the antibody to that envelope protein was coinvented at the U.S. National Institute of Neurologic Diseases and Stroke, NINDS, of the National Institutes of Health by the Head of ALS, Avindra Nath, under Cooperative Research and Development Agreement, between GeNeuro and the NIH. So GeNeuro owns the patent for the treatment of HERV-K envelope protein, which may possibly turn out to be the first disease-modifying drug for ALS. And GeNeuro has already been selected in the first round of its congressionally-directed medical research program for drug development and biomarker funding.

The first-in-human trial is targeted for July 2027. And should those initial clinical activities succeed, substantial funds have already been added to the 2027 defense appropriation to support ongoing activities. Again, you can read much more about the work on the GeNeuro website.

So in summary, in our second quarter, we've advanced our core business towards commercial revenue. We've substantially strengthened our balance sheet. We brought committed institutional investors to our company. We've established a key partnership with the U.S. military that creates a far broader opportunity for NRX-101 than we previously imagined. And we've added a potentially transformative portfolio of drugs that have the potential to treat some of the worst diseases that affect humanity.

With that, I'll turn it over to Mike to review our financial results. Mike?

Thank you, Jonathan. For the 6 months ended June 30, 2026, NRx reported a net loss of $18 million versus a net loss of $23.1 million during the comparable period in 2025. The change is primarily related to the impact of certain tariff value accounting measurements and other nonrecurring charges related to the conversion and restructuring of previously issued convertible notes incurred during the 6 months ended June 30, 2025.

For the 6 months ended June 30, 2026, NRx reported a net operating loss of $11.3 million versus a net operating loss of $7.6 million for the comparable period in 2025. The change was primarily driven by an increase in research and development and selling and general and administrative costs related to the anticipated near-term commercial launch of preservative free-ketamine, which is pending approval of the pending approval of ANDA.

As of June 30, 2026, the company had approximately $26.7 million in cash and cash equivalents versus $7.8 million as of December 31, 2025. This increase was primarily related to the company's completion of a public offering of common stock with gross proceeds of more than $22 million. Management believes current cash resources, the economic potential of pending ANDA launch anticipated growth in clinic revenue and opportunistic utilization of the company's active at-the-market offering facility will be sufficient to support operations for at least a year.

With that, I turn the call back over to Jonathan. Jonathan?

Thank you, and thank all of you for giving us the resources to operate from a stable platform. As previously noted, the second quarter of 2026 was a major inflection point for NRx in our ongoing mission to bring hope to the most vulnerable patients battling depression and suicidal ideation with noted advancements across all of our major platforms. So our goal of bringing hope to life is closer than ever, and now we're ready to take questions.

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

You just had a nice call. So I really just have one sort of big picture call or question. How do you think about launching KETAFREE when you have the NDA ketamine coming on its tail. And I guess my view is that's a very different drug because of its likely potential for reimbursement. But it's really the same drug. So I appreciate it's early, but how should we think about that? Because it's -- I get it's a high-quality problem, but nonetheless, it's a complex one. So any thoughts you can share would be great.

Tom, it's a great question, and thank you for asking it. First of all, KETAFREE, targets the market, and we believe it's a $750 million current market of ketamine that's used in hospitals and clinics, some has certainly used to treat depression. But the vast majority of it is used as an anesthetic and used for pain control. And we've talked about this a little bit before, but it's one of the things that there is repeating. KETAFREE by law has to have a comparable inert ingredients composition, to composition of the reference drug, which is Ketalar, drug that was formulated back in the 1970s. That means that the -- for reasons we don't understand, nobody seems to know. Ketalar was formulated as a [ hypotonic ] drug. The sodium chloride concentration is 6.4 milligrams per mL.

Now if we've gone to the FDA and said, hey, would you please give us a letter, telling us that NRX-101 and KETAFREE are 2 different drugs. They would have said, well, we don't write letters like that. So instead of what we did is, first, we submitted the ANDA at an isotonic sodium fluoride level at 7 milligrams per mill of salt. And FDA, of course, rejected it and said, you can't do that. You have to use the same salt concentration as the old reference listed drug. So we submitted, we reformulated, resubmitted at 6.4 milligrams per mL of sodium chloride and the ANDA was accepted for a review.

So what's happened as a result of that is that the preservative-free ketamine, the ANDA product is under the law, a whole different drug than NRX-101. They will have different -- assuming they both get approved, they'll have different NDC numbers. They'll have different commercial pathways. And while the label for NRX-101 with its NDC number, hopefully will include the treatment of depression. The label for KETAFREE never will. So if one of those drugs is reimbursed by insurance for treating depression, it's not substitutable with the old generic product. Does that answer your question?

Got it. No, I admit you have talked about this a little bit before, but it wasn't worth repeating because of it's subtlety. The answer is you got another trick up your sleeves.

Well, hopefully, it's more than a trick. Hopefully, it's sort of solidly grounded in pharma.

No, no, I don't mean in a negative way. I just mean they are going to be different drugs, so you are covered. So that's very useful.

Your next question is from Patrick Trucchio from H.C. Wainwright.

Congratulations on being a new father.

I will relay to Patrick. This is Luis in for Patrick because he's on baby duty -- I just have a couple of questions on the SPARC-TMS and then a follow-up. The trial positions in NRX-101 in broader treatment-resistance depression rather than suicidal bipolar depression. So does DARPA support a separate indication file? And does it change the timing or priority for the NRX-101 NDA now that the module 3 has been submitted?

Well, I think Dark is interested in research that can empower the military. So I don't think they focus on indications and drug approvals. That's the role of the FDA. From our perspective, NDA's incredibly expensive to submit. The PDUFA fee alone is close to $5 million.

So if this trial gets funded and as you can imagine, it's a kind of massive nondilutive funding that rarely happens. But you can read about the trial on clinicaltrials.gov. And if we're looking at a chance to go for this much broader opportunity in conjunction with the military, we'll probably take guidance from people like you, from our shareholders about whether to pursue both indications at once. My point of view is that if we have the resources, I think the bipolar depression indication is a very important one. Well, it's not an orphan disease. There are hundreds of thousands of people who have severe bipolar depression. It is a breakthrough therapy indication. FDA gave us a breakthrough therapy indication for NRX-101 and suicidal bipolar given that there is nothing else that's ever been shown to reduce suicidality or reduce akathisia while also reducing depression in those patients.

So our objective is going to remain to be to pursue both. But assuming the SPARC-TMS trial kicks off the way we hope it will, and as I said, people are welcome to look on the NRx Defense website to look on clinicaltrials.gov, that's a massively transformative opportunity for NRX-101.

That makes sense. And on the GeNeuro program in GNK-301, you talked -- you gave some nice color on that. The first in-human ALS targeted for July '27. What will be NRx's role in that program to reach that IND? Is that going to commit funding towards the GeNeuro? Or is it going to come from nondilutive sources?

It's a great question, and thank you for asking it. The folks who invested in our last round, the investors we talk to every day, have really given us an opportunity to fund the commercial launch of the ketamine family of products. And we take that commitment incredibly seriously. That's our key objective with the funds that have been entrusted to us.

ALS has a massive stream of available funding, and recognize that in this case, we're partnered with the National Institutes of Health. This drug was coinvented with the Head of ALS at the National Institutes of Health and NIH owns the patent together with us technically, and should the drug come to market, NIH gets a 3% royalty on anything that happens. But I don't think NIH isn't for the money, NIH is in it for the 6,000 people every year who get ALS and who are mostly dead within 3 years. That's why we're all in it. So there is a tremendous amount of federal commitment around ALS.

Just a few days after we were awarded this portfolio. I applied for the first $3 million of funding from the Congressional-directed medical research program. And sure enough, the 2 applications we put in were selected in the first round, and we were invited to submit a best and final bid, which we'll do by September 30. A number of members of Congress have formed an ALS Caucus and an additional $80 million has been added to the 2027 Defense appropriation.to potentially fund a clinical trial of any drug that could be shown to be a disease-modifying drug for ALS. And as I said in brief and people are probably going to need to dig into it if they really want to understand it, but it took me years to understand it.

The envelope protein, every virus is a little bit of DNA with an envelope of protein that keeps it from being immediately chewed up. The envelope protein for human endogenous retrovirus K causes ALS in laboratory animals and causes ALS in human cells. It's exquisitely neurotoxic. And you can block that neurotoxicity with a monoclonal antibody.against that endogenous -- against that envelope protein, in the same way, and once upon a time, I was involved in the first monoclonal antibody drugs that today treat macular degeneration. These are not drugs that cure a disease, but if you can identify a toxic protein in the case of macular degeneration, was VEGF, in the case of ALS, it appears to be HERV-K envelope protein, those monoclonal antibodies are like a sponge for spilled milk, they take and neutralize the toxic antigen.

So if we're able to advance this, there's all the philanthropic money and government money in the world to take risk that Wall Street investors generally don't want to take, and we're talking to many of those funding sources. But one of them is the U.S. military because combat veterans are known to have twice the rate of ALS as people who haven't been in combat. In fact, generally, if you want care through a VA hospital, you have to prove that your disability is service connected. And the law says that if you go to a VA hospital and can show that your combat that you're automatically admitted for ALS. That's how strong the association is. So the long answer, but ultimately, the short answer to your question is we expect to develop this with nondilutive sources.

And your next question is from Ed Woo from Ascendiant Capital.

Yes. Congratulations on all the progress. I was wondering, is it too early to think about international opportunities for any of your initiatives either in Canada or in Europe?

Well, on the ketamine front, I think there are international opportunities. They are also international suppliers. On NRX-101, we have worldwide or mostly worldwide patent coverage. And there's clearly an opportunity there. The robotic TMS opportunity, if it works in the SPARC-TMS trial, the way we hope it's going to work, has massive international implications. And the GeNeuro assets began internationally. Some of the coverage was lost while the portfolio was sitting in a Swiss bankruptcy, but there's still coverage for most of the patents. And these patents are disclosed on the geneuro.us website, so people can look at them one by one. There's still extensive patent coverage worldwide. And if these drugs show promise, I think one would expect that they will become global drugs.

Thanks for answering my questions, and I wish you guys good luck. Thank you.

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

Well, thank you all for joining us. As you can tell, it's been an incredibly busy quarter. In fact, I'm Indiana right now with 2 members of our team. Tomorrow, the first manufacture of GNK-301 is going to be initiated at a partner called Polymun in Vienna, and we're going to be excited to see you a quarter from now and hopefully have a lot to tell you. So thank you all for coming.

Thank you, ladies and gentlemen. That concludes the conference call for today. Thank you all for joining. You may now disconnect your lines.

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Discusses FDA First Cycle Review Conference Call. [Operator Instructions] I would now like to turn the conference call over to Brian Korb from Astr Partners. Please go ahead.

Thank you, operator. Before we begin, I'd like to remind everyone that certain statements made during today's call may be considered forward-looking statements within the meaning of applicable securities laws. These statements are based on management's current expectations and assumptions that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from these expressed or implied. Please refer to the company's SEC filings and today's press release for a discussion of these risks. NRx Pharmaceuticals undertakes no obligation to update any forward-looking statements, except as required by law.

Joining us today are Dr. Jonathan Javitt, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals; and Glenn Tyson, Chief Commercial Officer. Dr. Javitt will provide an overview of the company's recent developments and strategic priorities, followed by remarks from Glenn on commercialization activities and market readiness initiatives. Following their prepared remarks, we'll open the call for questions. With that, it is my pleasure to turn the call over to Dr. Jonathan Javitt. Jonathan, please go ahead.

Thank you, Brian. Good morning, everyone. It's a privilege to meet with you and update you on the progress of our abbreviated new drug application, otherwise known as an ANDA for preservative free ketamine. As you know from our press release, we have completed our first cycle review with FDA, and we're delighted to share with you that to the best of our knowledge, we have only one matter to clarify with FDA prior to approval. The agency has advised us that there are no major deficiencies related to our drug, to its ingredients, to its manufacture, to chemical manufacturing controls, to labeling or any related matter connected to the drug itself. The sole remaining item is a concern raised by a reviewer that the luer lock tip might deform in use and might not meet properly to the syringe.

Our vial is different from the glass vials that people are used to in that you don't have to open the top, put a syringe on a needle, push the needle through the stopper, draw the medicine, remove the needle from the syringe, dispose of the needle and finally administer the medicine to a patient. Instead, all you have to do is twist off the plastic cap of the vial, connect the luer lock syringe to the neck of the vial, draw the medicine and administer it with no chance of a needle stick injury or sharps waste along the way. The ANDA contained documentation that this vial has now been used in 3 currently FDA-approved products that have collectively shipped about 11.9 million doses in the last 12 months with no complaints, no returns, no adverse events and no recalls. Moreover, the ANDA contained testing data documenting in-process testing of 500 vials per manufacturing lot for each of our 7 lots with no malfunctions observed in any of the 3,500 articles that were tested.

The vial is manufactured under full design controls as specified in Code of Federal Regulations Part 820.3, which includes strict adherence to the ANSI standards underlying luer locks and precise testing procedures for the twist-off force that's required to open our vial. We actually measure it down to newton centimeters. We have a special testing rig that does this precisely and mechanically. FDA has inspected this vial component on multiple occasions during its plant inspections at our manufacturer for the other products. So in a meeting on Thursday, the FDA recognized the extensive measures we took to comply with medical device law related to the luer lock tip and the documentation of this both in the ANDA and on file at our manufacturer where it was already inspected. Accordingly, FDA asked us simply to submit an attestation from the manufacturer that our vial is manufactured on the same manufacturing lines using the same materials and methods of the 3 currently approved products. This attestation is being submitted today.

We believe the request we received is consistent with the final verification step rather than a request to generate new technical data, because the requested information was already available from our manufacturing partner, we're able to respond immediately. We're delighted by this outcome, and we believe it significantly derisks the likelihood of a near-term approval of our ANDA. As a result, we are planning to increase our manufacturing orders substantially beyond the first million units that we already announced to 5 million units of launch stock. In today's regulatory environment, only 14% to 18% of ANDA products receive a clean approval in the first review cycle. To have emerged with only one item that was classified as major, where we believe we've arrived at a rapid path to resolution with FDA is way ahead of the curve from our perspective. Importantly, this was not a review cycle that identified new studies, additional manufacturing work, labeling revisions or changes to our commercial plans.

Based on the feedback received, we continue to move forward with launch preparation, supply chain expansion, distributor onboarding and the commercial infrastructure necessary to support market entry once the review process is complete. As you know, ketamine is on the FDA drug shortage list. It's been identified as a strategic drug product by the military and the VA. Hence, approving a U.S. manufactured source of ketamine at a time when hospitals and clinics are forced to buy non-FDA-approved compounded ketamine from local pharmacies is a priority that goes all the way to senior levels of government. Our focus now is straightforward. We aim to complete the regulatory process, continue scaling inventory and to be prepared to launch into a market where reliable domestic supply remains critically important.

With the regulatory review substantially advanced and our commercial preparations accelerating, we believe NRx is well positioned to create meaningful shareholder value through disciplined execution and a clear path toward commercialization. Last quarter, we told you that we had recruited Glenn Tyson to serve as our Chief Commercial Officer, and I've asked Glenn to offer some thoughts on our commercialization plans, and then we'll take your questions. Glenn?

Thank you, Jonathan, and good morning to you all. Happy to have this opportunity to meet you and give you an overview of our commercialization plans underway. As you're aware, this ANDA is the first key step in our progress toward commercialization of a portfolio of assets that we believe will provide new hope for people suffering with serious mental illness. NRx is not relying on a single product strategy to carry the story. Instead, we are deploying a staged commercialization model that starts with the ANDA and builds towards the launches of premium reimbursed branded therapies, NRX-100 and NRX-101. If approved, these 2 products could provide much needed options for people suffering with severe depression and suicidality. The interventional psychiatry market for ketamine, esketamine combined is growing rapidly and will likely exceed $3 billion in 2027.

We're already in the planning stages of a commercial model for NRX-100 that we believe will achieve broad market access, significant penetration in the growing interventional psychiatry space and substantial revenue. What we can see is that the insurance reimbursed market is what's driving the profitability in this sector, and NRx looks to benefit from this with our portfolio of strategic assets. This launch sequencing allows NRx to generate potentially significant early cash flow from the ANDA while constructing a much more robust long-term market position with multiple proprietary assets. This first launch gives us the opportunity to set up a seamless distribution network that will both ensure we can meet market demand for ketamine and help solve the problem of the ketamine drug shortage in the U.S. And the ANDA, while launching into a generic market, has differentiating characteristics that when paired with an optimal distribution plan, we believe, will lead to substantial market penetration.

As a reminder, our ANDA product comes in a luer lock vial, as Jonathan just outlined, and this allows for needleless draws, is free of all preservatives, including benzethonium chloride, which is found in all other ketamine products currently on the market. And perhaps most importantly, we have consistent, reliable supply that is made in the U.S.A. Taken as a whole, this opportunity can expand access to ketamine in the U.S. for patients in need. Today, ketamine remains an important tool as a non-opioid anesthetic for many common surgical procedures as well as having a place in emergency medicine, pain management and within interventional psychiatry. Our distribution plan takes into account all the various customer types and channels, and we believe our launch dosage form of 50 milligrams, which is 10 mg per ml in a 5 ml vial will be seen as an important product that can reliably meet medical needs across a broad spectrum of sites and uses.

At NRx, we're serious about addressing the issue of drug shortages. And with an optimized manufacturing process and supply chain reliability, we can produce new batches very quickly and cover any market fluctuations created by other manufacturers' inability to guarantee consistent supply. We're pairing this with a streamlined and highly compliant ordering system that verifies the necessary licenses of all customers and then delivers product confidently. At this time, the commercial team is setting up all the necessary distributor contracts and preparing all the forms of -- and electronic systems for accurate and timely government reporting as well as finalizing implementation of financial reporting systems. We're also building required company infrastructure by setting up pharmacovigilance and medical information functions as well as other systems to capture any customer issues.

Because of what we've learned in recent market research with purchasers in all channels, we've increased our plans for initial commercial supply manufacturing from the 1 million vials already in plan to 4 million to 5 million vials to meet initial launch demand. We would not be making this level of inventory commitment unless we had high conviction in the opportunity, the market demand and our readiness to execute. Once the ANDA is approved and all labeling is finalized, we will be ready to launch and confident in our ability to deliver meaningful results for shareholders. That concludes my prepared remarks. I'll be available to answer questions upon the conclusion of this discussion. With that, I'll turn the call back over to Jonathan.

Thank you. Brian, would you like to introduce our questions?

Yes. Sounds good. Thank you, operator. Please go ahead. Appreciate it.

[Operator Instructions] And your first question is from Elemer Piros from Lucid Capital Markets.

Jonathan or Glenn, would you please explain how you were able to overcome what others are struggling with in terms of shortage and secure a U.S. supply of the drug is question one. And question two, if you could describe the economic benefit to NRx for this -- specifically for this first 5 million vial opportunity.

Well, thank you, Elemer. When you say how are we able to overcome a shortage? Well, the only way to overcome a shortage is to manufacture into that shortage. Now I think there are a couple of reasons why we are in a position to do that. Every vial of ketamine today is sold in a glass vial with a rubber stopper. Pharmaceutical glass is increasingly expensive and increasingly in short supply. More importantly, a glass bottling line can generally manufacture about 10,000 units in a manufacturing run. A blow-fill seal bottling line where you're fabricating a vial from a couple of pellets of plastic can manufacture 1 million units in the same amount of time with the same workforce or less because literally, the machines we're using take pellets of plastic, melt them into a little puddle. That puddle is infused with air to form the shape of a vial. That vial is automatically filled with medicine.

The machine seals the vial, puts a label on the vial, puts a wrapper on the vial, puts it into a box and puts it onto a pallet without a single human being touching that process. That's very different from an old-fashioned glass bottling line. So we have almost unlimited manufacturing capacity, at least unlimited compared to the ketamine market today. And we don't need to buy pharmaceutical glass in order to satisfy that capacity.

I see. So it was mostly -- or it is not necessarily drug related, but the entire process related and including the glass vials that leads to the shortage.

Well, correct. If what you're asking is whether there's a shortage of ketamine API, ketamine pharmaceutical ingredient, to our knowledge, there's not, and we have a very significant amount of ketamine API in the warehouse ready to go. Really the shortage is the capacity of the current manufacturing lines. And one of the problems is ketamine is a fairly well-known drug. Its price is not exorbitantly high. So if you've got a choice between devoting a manufacturing line to a biologic that could sell for thousands of dollars per vial or an old sterile generic injectable product, the expensive new drugs are going to capture the manufacturing capacity out there.

The other thing to recognize is that much of the ketamine supply today is coming from overseas. Overseas supply lines have been significantly disrupted as anybody who reads the news knows. So there's a real need for a high-capacity supply that's manufactured in the United States, and that's what we aim to do.

And to part 2 of the question or the second question, Jonathan, if you could explain what you expect.

At some point, we may give more guidance about the margins that we expect to achieve with this product. But I think just in terms of common sense, people can recognize that a couple of pellets of plastic is a whole lot less expensive than a glass vial, a rubber stopper, a metal crimp and the machinery that's required to put all that together. And recognize that glass itself is not problem free, keeping lint out of glass, washing glass is an ongoing challenge for people who are in that sterile injectables business. So we expect that our unit margins will be significantly higher than the unit margins of people who are bottling in glass, and we'll give some more precise guidance about that at the right time.

Yes. And do you think you could maybe elaborate on what sort of premium you hope to get for the preservative-free version of ketamine?

I think it's premature to talk about what sort of premium we might get. And quite frankly, if at the outset, the preservative-free advantages simply capture additional market share, that will be a major win. If we're able to get a premium, that will be a win on top of it.

Your next question is from Patrick Trucchio from H.C. Wainwright.

It's [ Ebel ] on for Patrick. I guess, has a new GDUFA date been assigned for the amended submission? And is it going to be treated as a minor amendment or a major amendment? And what does the shortest possible review cycle really mean? And then separately, what specifically changed in the KETALAR reference listed drug label?

GDUFA date hasn't been assigned. Therefore, we can't answer the rest of the question. But FDA's posture in the call was extremely collaborative. Not only was the Office of Generic Drug Products on the call, but so was the leadership of FDA's, Center for Drug Evaluation review, otherwise known as CDER. FDA recognizes that this is a strategic drug that's in drug shortage where the supply chain is primarily an overseas supply chain, and there's a very high priority that goes all the way to the Secretary of Health and beyond to reshore the manufacture of strategic drugs to the United States. With regard to the specific change in the RLD, I don't have that information for you today.

We can certainly get it out there, but it was not a significant change. People make labeling changes all the time in old drugs. And in this case, a small change was made after we had filed the ANDA. So we just needed -- we've already updated the ANDA to incorporate that change. We got that filed last May.

And then I guess, have you submitted the manufacturer certifications yet? And if not, when do you expect to submit those?

This is a manufacturer that's been repeatedly inspected by FDA. They're in VAI status. So I think we're fine on that front.

Your next question is from Tom Shrader from U.S. Bank.

Can you give us a little update on how much preservative-free text you'll be able to get into the label? Will you be able to give any sort of comparative data or things like that? And then, Glenn, I enjoyed your comments. It sounds like you know what you're doing. I'm curious if you can give us some background on other drugs that have launched into this sort of filling shortage market and what you're sort of looking at as a stalking horse for how to pull this off? And then finally, Jonathan, if you could, I'd love you to give us an update on the BLA time line. That's your next big catalyst. So I appreciate you're focused on today, but as much detail as you could give us would be great.

So Tom, with regard to what we expect to see in the label, I think the fact that it's preservative-free hopefully will be noted in the label. It may simply be noted by the fact that there's no preservative listed, in which case, we'll be free to tell the market that it's preservative-free. I wouldn't expect to see comparative data in an ANDA product because typically, ANDA products are labeled with the label of the reference listed drug. So that would be a little bit new to say, well, let's put information in the label about toxicity associated with benzethonium chloride.

On the other hand, in our outreach to the market, we're certainly free to identify the toxicities associated with benzethonium chloride. And in fact, the toxicology report is posted by the FDA as part of our open docket where we've requested a citizen petition to remove toxic preservatives from injectable drugs. So for the most part, labels are written in point type, and that's typically not where people look for that kind of information.

Before we go to Glenn, what was the second question you had for me, Tom?

It was at the end, an update on the BLA, what you can tell us about where you are.

Well, BLA is for biologics...

I'm sorry, NDA. I misspoke NDA. -- sorry...

Yes, we were poised to get that submitted in June. And as we started to run into this question on the luer lock and provide FDA with information on that, we wanted to get this resolved because that same vial applies to both products. So now that we've cleared this, we're going to turn our attention back to the NDA. We've, in the background, been talking with FDA about how they'll interpret the real-world evidence. And as you've seen, there's both a presidential executive order and there's a direct language from the Congressional Appropriations Committee that funds the FDA, guiding the FDA to use the 65,000 patients of real-world evidence, which not only demonstrates and we've presented this evidence at a clinical meeting. So it's out there.

The evidence not only demonstrates the significant efficacy of ketamine in resolving depression, suicidality, but demonstrates that the effect is larger and more rapid than the effect seen with intranasal esketamine. So we're -- we've consistently said that we think the NDA is going to get dealt with over the next 12 months. That was 12 months from June. And quite frankly, I think that having dealt with this packaging item ahead of time keeps us within that time line.

Thank you, Jonathan. Yes. So to your other questions, just a couple of things. First, I'll say that in the carton packaging that the luer lock vial will be contained in, there is statements about being preservative-free. So it's not in -- I'm not sure how significant it will be in the actual label, but certainly in the packaging that will be noted. And we will ensure that all of our distributors are aware of the differences of the product and the potential benefits here. As part of our market preparation, we've -- as you can imagine, we've done a fair amount of market research is still underway. And we're interviewing purchasers at various levels within hospital systems, within specialty accounts, within interventional psychiatry and various clinics. And we're testing the profile to understand what will make a difference. And what I can tell you is that the preservative-free comments are certainly things that they're concerned about.

I think the awareness of benzethonium chloride and any challenges that may present to their patients is not well known to them, but they are happy to hear about the preservative-free nature of our product. Secondly, the fact that we are talking about consistent supply is something that's very important to them. It's a very sensitive issue and all customers in ordering are having to toggle between manufacturers and compounding pharmacies, which creates challenges in terms of their consistent supply and they're feeling about having kind of a net -- a safety net of supply that they can count on. So that's very important to them, and we're hearing that pretty consistently across the board.

I think just in final, I would say it's uncharacteristic as a market launch into a supply shortage. And what we're trying to understand is really what it means to our customers and how we can talk to them and ensure that they are very, very clear on the benefits of the product that we have and how do we move them to an ordering system that is very simple and that is reliable. So that's really where we are with trying to penetrate this market and meet the drug shortage. And that's meeting with very positive comments from our customers that we're speaking with.

If I can squeeze in one quick follow-up. How many customers do you think you really need to hit to get, I don't know, a significant fraction of the market? How lumpy is the target market?

That's a really good question. So it's a market that's segmented into the purchasers are on-label use, right, in hospitals, hospital systems, et cetera. And then you have the interventional psychiatry space. So there's about 8,000 interventional psychiatrists in the U.S., but it's very highly concentrated in terms of the number of customers that are purchasing. And it's -- we are -- I believe there's probably about 2,500 that are purchasing the majority of the ketamine here. So maybe that's not an exact perfect Pareto principle, 80-20 rule, but it's pretty close.

And your next question is from Ed Woo from Ascendiant Capital.

Yes. Congratulations on all the progress. Assuming that you can get approval tomorrow or how quickly after approval will you be able to start selling product?

That's a great question. As you know, we guided at the end of the quarter that we had initiated manufacturing of 1 million units of launch stock, and we just told you today that we're increasing that to 5 million based on the funding that we raised and based on the market forecasts that we're seeing. So our anticipation is that we should be able to start shipping within a couple of days of FDA approval.

There are no further questions at this time. I will now hand the call back over to your host for the closing remarks.

Thank you very much for joining us, Jonathan. I don't know if you have any final comments.

No. All we can really do at this point is thank our shareholders, particularly thank the people who stepped in on our recent public offering to provide us with the resources to be ready to launch this drug when it's approved. We look forward to continuing to bring you news. We'll see you on the earnings call in about a week. And thank you for joining us.

Thank you. Ladies and gentlemen, that concludes our conference call for today. Thank you all for joining. You may now disconnect your lines.

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter 2026 Earnings Conference Call. [Operator Instructions]

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 statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made in 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-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 and 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 bioequivalents 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 disciplined review letter on quality, requesting only administrative changes that FDA itself identified is 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. And on May 5, we transmitted our first commercial manufacturing order at the 1 million unit per batch scale. The blow-fill seal process we're using delivers more than tenfold throughput compared to traditional glass bi 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 1 million units per week. Timing matters here. As of April, sterile intravenous 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 in 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 and 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 constrain 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 reinforced 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 18, President Trump signed an executive order titled Accelerating Medical Treatment for Serious Mental Illness, directing Acceleration of approval pathways for psychedelic medicines to treat depression, PTSD and suicidality and directing FDA to award Commission'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 commission'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 in suicidality.

Moving to NRX-101. When we advance two parallel tracks in our original indication of suicidal bipolar depression, we've initiated an NDA filing with submission of Module 3 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 IIb/III study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated ONE-D 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 nondilutive federal funding anticipated.

This use of NRX-101 was not anticipated until recent data have shown a doubling of clinical response and an eightfold 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 nonclinical 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, 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 neuro navigation platform has already received FDA 510 clearance for TMS navigation. We plan to unveil the prototype of Zeta at the Clinical TMS Society Annual Meeting in Boston in early June.

Depression, if you want to see it, touch it, feel it first hand, please join us. Depression and PTSD carry a fivefold increased risk in frontline troops and first responders and personnel who are on standard antidepressants are not combat deployed a short-term nondisqualifying treatment is both a health care 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 8 or more locations by the end of the second quarter. In February, we appointed Professor Josh 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 suicidality. Approximately 50% of patients with treatment-resistant depression relapse within 6 to 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 AG, which brings together the combined clinic base together with an installed 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, 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, Swiss company funded with existing cash and includes a broad patent portfolio, cell lines, antibodies, regulatory files and data from pre-completed human clinical trials. Dr. Herve Perron, formerly Chief Scientist of 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 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 3 months ended March 31, 2026, Rx 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 3 months ended March 31, 2025, representing a 74% and year-over-year reduction. This change is primarily related to the impact of certain fair value accounting measures and other nonrecurring charges.

For the 3 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 product, aligning 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 3 months ended March 31, 2026, research and development expense was approximately $1.3 million as compared to approximately $0.8 million for the 3 months ended March 31, 2025. General and administrative expense, which includes selling costs for the 3 months ended March 31, 2026, was approximately $3.8 million as compared to approximately $2.9 million for the 3 months ended March 31, 2025. The drivers of the changes of both research and development and G&A expense were both 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 running, 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 Jon. 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 nondilutive 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 nondilutive 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 place in us, our goal of bringing hope to life is closer than ever.

Operator, we're now ready to take questions.

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

A 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? Do you -- 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, you're describing -- thank you, Tom. And 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 and given the drug shortages and what we believe will be a perception of not only of quality but U.S. manufacturing and reliability. We belie 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 at reach, part of our preservative-free ketamine strategy is that traditional market. But the other part is the clinic market that right now really doesn't have access to the wholesalers. And we've tested this. We've had our clinics call and try to buy from wholesalers. And 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. So those clinics are required to rely on a web of compounding pharmacies.

And we intend to displace that compounded product with reliably manufactured FDA-approved GMP product. So 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 is an increasing reliance on ketamine to treat pain syndromes as well.

Got it. Got it. Okay. And then 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 want to see in those records? And is that all negotiated? We have 65,000 records that show the boxes you want to see filled? Or is that a negotiation that's on going? I mean 65,000 is a lot. It's probably 60,000 more than you need if they like the record. So I'm just kind of curious where that process is in agreeing on what these records need to show?

And when we say records, we say record -- we mean records on 65,000 unique patients. At the risk of sounding numerous, everything with the FDA is a negotiation. But it's a negotiation that occurs through well-established channels. So what we agreed to in our meeting with FDA was we would -- they acknowledge that the preliminary cuts of the data looks promising.

Osmind has previously published data on about 20,000 patients, and that was part of our meeting package. So 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. So 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 going to be in a position where we keep crunching the data over and over again, but sort of measured twice, cut once. So right now, we're waiting for FDA's response to our statistical analysis plan. And as soon as we've agreed on exactly what tests will be used, we'll apply that and submit the data.

And any time marks for any of that, that you can share?

Well, there are some regulatory costs involved. So we're expecting FDA to come back to us approximately by the end of the month. I don't want to give you an exact date, but I don't have it at my fingertips, but that's about the time frame.

Your next question is from [ Omer Perez ] from [ Lucid Capital Market ]

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, we're not in a very good position to understand other people's products. We know there is a shortage, whether it's a lack of glass vials, 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 and do that by having a couple of years of ketamine drug ingredient in the warehouse by having high-volume assembly lines using blow-fill seal that are capable of making 1 million units in a single week if you run the line around the clock 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. So we know how to address the shortage, but I'm not sure I can tell you exactly why the supply chain is undersupplied.

Yes. So 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.

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

Well, I would never want to predict what a regulatory agency will do. 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 context. And the law says that all ingredients in a drug should be safe.

This particular preservative was put into ketamine back in the 1970s. And in general, nobody has really looked at the formulation until we got involved. Quite frankly, when we got involved, I asked, well, why is it there? And the answer was, oh, it's a necessary excipient, but ketamine will come out of solution without it. And I said really. And 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.

And it turned out that it was the benzalkonium chloride in the eye drops that was killing the essential lipid component of human tears. So that's how I first learned about this class of preservatives. And that's why you see preservative-free eye drops on all the drug store shelves. So it will be interesting to see how the regulatory world ultimately reacts to this. But I think in general, the regulatory environment is pro-safety and anti-preservative.

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

Generally, that's a 6-month process. But remember, we already have Fast Track approved for NRX-100. So we're already entitled to priority review.

[Operator Instructions] And your next question is from Patrick Trucchio from H.C. Wainwright.

Just first on KETAFREE. I thought you mentioned that the commercial manufacturing is now initiated a $1 million per dose month level. I'm wondering what inventory level do you expect to have available at the time of the launch?

At the time of the launch, we'll have at least 1 million units in the warehouse. And depending on what we see between now and then, we may take that up by 0.5 million or 1 million units.

Got it. And for NRX-100, mentioned that have fast track review and that maybe hearing back on the CMPV could take 6 months. I guess, does this imply that you might be able to get a quicker review just with the standard Fast Track?

Well, I don't know if anybody knows exactly how much a CMPV speeds up the process, but priority review is a pretty well-established pathway, and we know it does speed up the process. So 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 the most important thing is to come to agreement with FDA on the real-world evidence and get that submitted. And in that regard, the President's executive order from April is enormously supportive and completely apart from the executive order from the White House, if you look at the appropriations language in the FDA budget appropriation for this year, Congress has focused on the use of real-world evidence in the approval of drugs for depression and suicidality. So 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.

Yes. That makes sense. And then 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 if one had a dramatically positive result, and that wouldn't be P0.05, but P0.01 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 doubled the effect of transcranial magnetic stimulation on depression, but increased that effect more than eightfold 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. But until the data is 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. And if you take a look at the 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.

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 heads down work. Our team has grown. Our proximity to market, we believe, has substantially increased or got shorter to be precise. And we're incredibly grateful to the investors who've come on board, who have lent their support and given us their confidence. So 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.

Hello, everyone, and welcome to NRx Pharmaceuticals, Inc.'s 2025 Annual Meeting of Stockholders. Before we get started, I would like to go over a few logistical items so you know how to participate in today's meeting.

[Operator Instructions] The polls are now open, viewers can go to www.cstproxy.com/nrxpharma/2026, as shown in the chat box for all attendees.

At this time, I would like to now introduce Jonathan Javitt, Chairman of the Board of Directors of NRx Pharmaceuticals, Inc.

Good morning, and welcome to the NRx Pharmaceuticals 2025 Annual Meeting of Stockholders. I'm calling the meeting to order at 10:00 Eastern Daylight Time.

I'm Jonathan Javitt, Chairman of the Board of Directors of the company and one of its founders. On behalf of the Board and the executive management team of the company, we hope that you and your families are doing well. We'd like to thank all of those who have made it possible to conduct this virtual meeting, and we look forward to interacting with you today.

We also look forward to holding future meetings in person now that we have clinical facilities open and a place where we can show you what we're doing to save lives on a daily basis.

I'm going to act as Chairman of the meeting; and Michael Abrams, our Chief Financial Officer and Corporate Treasurer, will serve as Secretary for the meeting.

Now I see that we have 18 people in attendance. If you're a stockholder and you'd like to be able to ask questions, please log back in using your control number. Without that control number, you don't have access to the ability to ask questions as part of the meeting. And on logging into the meeting by your unique join link with your control number, each of you were presented with an order of business for the meeting.

Also presented was a list of the rules of conduct for the meeting. To conduct an orderly meeting, we ask that participants abide by these rules. As stated in the rules of conduct, stockholders will be on mute during the duration of the meeting. If you want to ask a question during the meeting, you can submit text questions by typing your questions into the questions chat pane of the control panel.

You may submit your questions at any time during the meeting. Questions pertaining to the conduct of the meeting will be addressed during the session, if relevant. All other questions will be collected, considered during the Q&A session, along with other questions submitted in advance of this meeting. At the end of -- and we'll answer those questions at the end of today's meeting, if time permits.

So thank you for coming. Thank you for cooperation with those rules. And before I turn it over to Mr. Abrams, today is the day before we plan to announce our annual earnings for 2025. There will be a conference call announced at which we're going to be at, presenting detailed information on our progress and answering questions on our progress as opposed to questions related to the business of today's meeting.

But what I would like to say is that this has been an extraordinarily pivotal year for our company. After years of R&D, we're in the FDA with at least one drug that we hope can be approved this year. We have clinics that are treating patients every day, changing people's lives. And we're deeply grateful for your trust in us, your participation with us in this mission and our mutual expectation that not only will we benefit our patients, but our stockholders.

So with that said, I ask Mr. Abrams to give the Secretary's report on the qualification of this meeting to proceed.

Thank you, Jonathan. This meeting is held pursuant to a written notice mailed to all stockholders of record as of the close of business on February 12, 2026. A notice mailed to all stockholders was accompanied by the proxy statement, form of proxy and the annual report for fiscal year 2024. These documents will be filed with the records of this meeting. In addition, the proxies and the certified list of stockholders are in the custody of the Inspector of Elections.

This is Jonathan Javitt again. Ms. Aqui has been appointed Inspector of Elections and has taken the oath of office, which has been filed with the company's records. Ms. Aqui, do we have a quorum?

Yes. The Inspector of Elections has reported that at least a majority of the company's issued and outstanding capital stock entitled to vote are represented at this meeting, either attending the meeting or by proxy. This constitutes a quorum of the stockholders and all legal requirements for holding this meeting have been satisfied.

Thank you, Ms. Aqui. The meeting is now lawfully convened and ready to transact business. You've received a copy of the order of business, which includes the matters to be submitted to a vote of stockholders.

At this time, the polls are now open. Stockholders who have sent in proxies do not need to take any further action at this time. If you've not sent in a proxy, please visit the following website in order to vote your shares during the meeting while the polls are open, and that's https://www.cstproxy.com/nrxpharma/2026. You'll need your virtual control number in order to vote your shares. That control number was provided in the e-mail you received upon registering for the meeting.

And again, I note that we have 19 people in attendance, all of whom are logged in as guests, none as investors. In order to be able to ask a question, you need to re-log in as an investor with your control number.

The first item of business is a proposal to elect Chaim Hurvitz and Michael Taylor as Class I members of our Board of Directors, each to serve for a 3-year term.

Is there any discussion concerning the election of directors? No discussion has been noted on our portal or online.

Therefore, the second item of business is a proposal to approve an amendment to the NRx Pharmaceuticals, Inc. 2021 Omnibus Incentive Plan.

Is there any discussion concerning approval of the amendment to the NRx Pharmaceuticals, Inc. 2021 Omnibus Incentive Plan? I note that we've received no questions through the portal. And at this moment, nobody has logged in as an investor to be qualified to ask a question.

The third item of business is a proposal to ratify the appointment of Weinberg & Company as our independent registered public accounting firm for the fiscal year ending December 31, 2025.

And I'd like to note on behalf of management that the reason we changed auditors is when we started HOPE Therapeutics, we needed a larger audit firm than our prior auditor in order to be able to audit the operating businesses of HOPE Therapeutics and to deal with the revenue recognition issues associated with providing medical services. And we found that Weinberg was able to expand its services to us to encompass that suite of services.

Is there any discussion concerning the appointment of Weinberg & Company as our independent registered public accounting firm for the fiscal year ended December 31, 2025? We've received no discussion on this matter.

The fourth item of business is to approve the compensation of our named executive officers via a nonbinding advisory vote.

Is there any discussion concerning the approval of the compensation of our named executive officers via a nonbinding advisory vote? I note that no discussion has been offered via the online portal.

And we're now at 22 guests with nobody logged in as an investor. Has everyone who desires to vote on the proposals done so? Having not heard from anyone, I hereby declare the polls closed. The Inspector of Elections will now tabulate the votes and report the preliminary results before the close of the meeting.

So while we wait for the votes to be tabulated, given that additional people have joined, again, I'd like to invite all of you to attend our earnings conference call, which has been announced online. 2025 is the first year that we've operated as a revenue-generating clinical entity in addition to operating as a biotechnology R&D company. We're going to be updating investors on our progress towards drug approval this year, and the reasons we're optimistic about having a solid financial operating history by the end of the year.

Do we have a tally? Mr. Secretary, do you have a tally from the Inspector of Elections?

Yes.

Would you please read the tally?

I don't actually have the tally. Stacy, are you going to read the tallies?

Do you need me to read the announcement of the voting results? Yes, I can read the results.

Yes, please, Ms. Aqui.

Yes, of course.

Okay. No problem. The proposal to elect Chaim Hurvitz and Michael Taylor as Class I members of our Board of Directors, each to serve for a 3-year term, the Inspector of Elections advises that each of Chaim Hurvitz and Michael Taylor has received a plurality of the votes cast from the holders of shares either attending the meeting or represented by proxy and entitled to vote on the election of directors.

On the proposal to approve the amendment to the NRx Pharmaceuticals, Inc. 2021 Omnibus Incentive Plan, the Inspector of Elections advises that the holders of the majority of the votes as either attending the meeting or by proxy at the annual meeting have voted to approve such a proposal.

Under proposal to ratify the appointment of Weinberg & Company, P.A. as our independent registered public accounting firm for the fiscal year ending December 31, 2025, the Inspector of Elections advises that holders of a majority of the votes as either attending the meeting or by proxy at the annual meeting have voted to ratify the appointment.

The proposal to approve the compensation of our named executive officers via a nonbinding advisory vote, the Inspector of Elections advises that holders of a majority of the vote as either attending the meeting or by proxy at the annual meeting have voted to approve such proposal.

Mr. Chairman, the final results of the stockholder meeting reflecting all proxies received by mail or otherwise through the close of this meeting and any votes cast during this meeting with respect to each of the proposals will be included in the final report of the Inspector of Elections and will be published in the Form 8-K within 4 business days after the final results are known and will be available upon request.

Thank you, Ms. Aqui. We've received no questions from shareholders via the online portal, and therefore, there being no further business, this meeting is now adjourned.

I want to thank you for attending today's virtual meeting for the support you've shown NRx Pharmaceuticals, Inc.

We'll now have a brief question-and-answer period if there are other questions that are outside the immediate business of the meeting. There are no questions on the online portal. Mr. Abrams, have you received any questions online?

Jonathan, we've not received any additional questions to address during this Q&A session, and this concludes this annual meeting.

So again, we thank you for attending. We hope that we'll see you on our earnings conference call. Have a good day.

Good morning, everyone, and welcome to the NRx Pharmaceuticals, Inc. Corporate Update Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I will now turn the call over to Brian Korb. 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 statements 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, 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-Q, which may be accessed from the Investor page of the NRx Pharmaceuticals website.

Joining today's call is Dr. Jonathan Javitt, our Founder, Chairman and CEO. Dr. Javitt will provide an important regulatory update and a material addition to NRx's development pipeline. Following his prepared remarks, we will take questions.

I will now turn the call over to...

Thank you, Brian. Good morning, everyone. Thank you for joining us. When we last spoke with you, we advised that we had submitted an abbreviated new drug approval or ANDA application for our preservative-free formulation of ketamine for which we've applied to the FDA for the proprietary name of KETAFREE. I'm pleased to announce that the FDA has notified us that the agency has agreed to receive the filing. Specifically, the FDA advised us in their letter that it made a threshold determination that the ANDA is substantially complete and on that basis, the ANDA was received for review. The agency has signed a July 29, 2026 goal date for completion of the ANDA review.

Over the next 6 months, the agency will review the chemical manufacturing controls, stability and other critical data to ensure that KETAFREE meets current standards under the Generic Drug User Fee Act. As we've previously shared, KETAFREE is the first preservative-free formulation of ketamine that specifically does not contain a preservative Benzethonium Chloride, a preservative that's not recognized as safe by the FDA and is not even allowed to be used in hand cleansers and topical antiseptics under current law. BZT was added to ketamine back in the 1970s when it was originally formulated as a multi-dose vial that was intended to be shared among several patients. That practice is no longer allowed in U.S. health care facilities.

NRx has filed a citizens petition with an expert toxicologist detailing the dangers of BZT and seeking to have it removed from all commercial presentations of ketamine. We posted that toxicology report on the Internet. In an era, when ketamine was used primarily for anesthesia and there was little likelihood that patients would receive ketamine on a regular basis. The exposure to BZT associated with a single dose of ketamine might not have been alarming. However, when ketamine is repeatedly used for treatment of depression or pain control, the toxicology report that we published documents that the dose of BZT administered approaches known levels of toxicity.

I first became acquainted with the risks associated with this class of preservatives in the 1990s when ophthalmologists began to seek the cause of chronic dry eye syndrome seen in many glaucoma patients. The root cause was traced to Benzethonium Chloride preservative that was used then in most eye drops and artificial tears. Benzethonium Chloride was shown to be toxic to cells of the eyes conjunctiva and cornea, which led to the development of preservative-free eye drops and artificial tears that you see in pharmacies today.

Our ANDA application seeks approval for NRx to market ketamine for its currently approved uses and sales of ketamine for those uses today worldwide approximate $750 million a year according to industry reports. There's additionally a substantial amount of compounded ketamine sold to clinics today in the United States because of the chronic shortage of manufactured ketamine. If our ANDA is approved, we would expect to gain a substantial share of today's current market. Should our citizens petition be approved and preservative containing ketamine no longer allowed for sale, we would expect to gain a larger market share, which could also result from increased recognition of the dangers associated with BZT and other preservatives of its class.

As I said, BZT is not generally recognized as safe by the FDA. Although graft determination was -- graft, of course, is generally recognized as safe, determination was not required back in the 1970s when this preservative was first added to ketamine and several other sterile products. It's since been removed from all but 20 currently marketed sterile products, of which ketamine is one. The FDA has clearly recognized the dangers associated with Benzethonium Chloride and does not even allow its use for hand cleansers and topical antiseptics. As you know, removal of toxic substances from foods, drugs and vaccines is a key initiative of the administration's MAHA or Make America Healthy Again initiative.

Approval of our ANDA filing on or before July 29, 2026, which is the goal date, would enable NRx to earn significant revenue in the second half of 2026. We've manufactured 3 commercial lots of KETAFREE and aim to have at least 1 million doses manufactured and ready to ship by next July. Rather than using traditional glass vials that require low throughput filling equipment and create a supply chain challenge for glass vials from time to time, our manufacturing program uses modern blow-fill seal technology capable of producing more than 1 million doses per month.

As you know, ketamine is deemed a strategic drug for the United States. And just last month, the FDA awarded a Commissioner's National Priority voucher to a U.S.-based manufacturer of ketamine drug ingredients or API, emphasizing the need for U.S. manufacturer of this critical medicine. We've been in touch with that manufacturer. And when their U.S. manufactured API is available, they estimate 2027. We anticipate changing to that supply.

As a preservative-free formulation of ketamine is an important invention, we filed a patent application with the USPTO to protect our intellectual property surrounding this patent. It was previously believed that Benzethonium Chloride was required not only to maintain sterility, but it was believed that Benzethonium Chloride was actually an excipient that was part and parcel of the product.

As noted, the existing generic market for ketamine has been projected at approximately $750 million a year. We believe that KETAFREE made in the United States and offered without any toxic preservatives offers patients and clinicians a superior option. We'll continue to work diligently with the FDA to move our application forward as rapidly as possible and to provide a safer version of this critical product to the American public.

As you know, we are also developing NRX-101, a fixed-dose combination of D-cycloserine and lurasidone for treatment of suicidal bipolar depression. FDA awarded us breakthrough therapy designation for this drug prior to the COVID pandemic. Based on important new information, we've now amended our investigational new drug file to include the use of NRX-101 in association with Transcranial Magnetic Stimulation. Last month, we saw a publication of the exciting and unanticipated finding that low-dose D-cycloserine, the active ingredient in NRX-101 when combined with a 1-day protocol of Transcranial Magnetic Stimulation, or TMS, resulted in an 87% clinical response and 72% remission from both depression and suicidality. This has triggered exceptional interest in the use of D-cycloserine to enhance the efficiency of TMS in the treatment of depression, suicidality and PTSD.

D-cycloserine like ketamine blocks the NMDA receptor and enhances neuroplasticity. Although in the context of TMS, D-cycloserine is used at a low dose, which does not block NMDA and is believed to be neuroplastic. Recently published real-world efficacy data provides the confirmatory evidence that was seen in prior randomized clinical trials that low dose of D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS. You can find those references in our recent filings.

Of note, DCS alone is contraindicated in patients with depression, while NRX-101 is not. That's because we added a low dose of lurasidone to block side effects of DCS that were well known at the time the drug was originally marketed. This creates an opportunity to develop NRX-101 for use in conjunction with TMS to treat depression. NRx has more than 25,000 manufactured doses of NRX-101 at the appropriate strength on hand and has launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient. That would happen under the expanded access and federal right to try laws. The market estimate for this newly validated indication for NRX-101 should it receive an FDA approval is in excess of $1 billion. We're in active conversation with manufacturers of TMS devices to initiate a definitive clinical trial that would seek to demonstrate the benefit of NRX-101 in augmenting the effects of TMS to a level of statistical significance required for drug registration for that indication.

Should we succeed, millions of patients will have a new option for treating suicidal depression, a condition that's reached epidemic proportions and NRx shareholders will benefit from this scientific advance. Our progress towards ANDA approval in the near term and a new pipeline target while continuing the development of Hope Therapeutics National Network for care delivery are transformative steps for the company and for the treatment of mental health in the United States.

Operator, we're ready to take questions.

[Operator Instructions] And your first question comes from Thomas Shrader with BTIG.

This is Jenny on for Tom Shrader. I just want to ask how much does the ANDA derisk the NDA?

I'm sorry, would you please repeat that question?

Yes. How much does the approval of the ANDA derisk the NDA that you have filed?

The ANDA is completely separate from the NDA. And as we discussed in August, there's a slight difference in the formulation of the innovative form of ketamine that's in the ANDA versus the form that's in the NDA. That's because FDA asked us to keep the salt concentration in the ANDA formulation identical to that of the reference drug [ KETILLAR ]. So there's about 6.4 milligrams per ml of sodium chloride in the ANDA form. There's slightly more an isotonic level of sodium chloride in the NDA form. And therefore, these 2 products, even though they have the same active ingredient, will have different drug numbers and also different commercial paths, potentially different pricing should both be approved.

Next question comes from Patrick Trucchio with H.C. Wainwright.

Congrats on the FDA's acceptance of the KETAFREE. And we have a bunch of follow-up questions. The first is now that you've established readiness to scale manufacturing to 1 million vials per month, I'm wondering how that aligns with expected demand across anesthesia, pain and psychiatry markets. And as well, is this sufficient inventory should the citizen position to remove Benzethonium Chloride be approved? And can you kind of walk us through that process?

We believe that we have 5 years of API available in the warehouse. And yes, we can scale up the manufacturing throughput substantially. We could even add a second line, if necessary. But given the throughput capability of the low-field steel manufacturing technology, it's absolutely scalable to meet the full market demand if we ever had that opportunity.

Right. And with the FDA confirming ketamine as a national priority drug through the CNPV pilot, I'm wondering if you could tell us the status of your CNPV application for NRX-100 and what, if any, formal interactions would you expect to have with the FDA?

I know that the FDA is aware of the filing. I was invited to attend one of the commissioner's closed door listening sessions and staff knows about the application we've made. As you know, there have been other than the CNPV that was awarded to an ingredient manufacturer, there have been no CNPVs awarded to any of the psychedelic drugs yet. And the commissioner has said publicly that this class of drugs is a priority for him.

Got it. And then just on NRX-101 with bipolar depression with suicidality as well as the TMS augmentation. With the real-world data showing D-cycloserine doubling efficacy of TMS, I'm wondering if you could expand on the design of the planned confirmatory Phase III trial that's expected and how that may support both an accelerated approval supplement and label expansion?

And then separately, maybe you can talk to us a bit more about TMS and its use in interventional psychiatry in the U.S. and other markets. And just in terms of sort of penetration in TRD and in other indications, if there are others and how we should think about the TMS market more broadly?

I'm going to answer the second question first, and then I'm going to ask you to restate the first part of your question.

So yes, as you know, we believe TMS is a real game changer for the treatment of these conditions. The psychiatry world has finally recognized with the SPECT results that SSRIs are the end of an era. You're talking about a class of drugs that is now known to be about 30% effective that has a massive side effect aside from the suicide black box warning on every SSRI label. SSRIs result in weight gain. They deprive people of much of their sexual pleasure. They have a host of other side effects that patients really hate. But more importantly, SSRIs to qualify people for [indiscernible] sessions. As you know, I'm a pilot. And any time a pilot takes an SSRI, that person is off of flight status for 5 years. So it's a huge disincentive for a pilot, an air traffic controller or a first responder, a frontline troop in the military to even admit to having depression because it means the end of job stats.

On the other hand, not only are we seeing efficacy from TMS from a number of manufacturers, and we don't make TMS machines, but we talk to most of the people who do. Without cycloserine, people are reporting 50% to 60% response rates. The Stanford same protocol showed a much higher response rate, although the durability of that is less certain. And then you have this randomized controlled trial done in Calgary with 50 patients, showing more than a doubling of the TMS effect when you add D-cycloserine, not because it's an additive antidepressant effect. In fact, the D-cycloserine dose that's used is not an antidepressant dose. It's down around 150 milligrams or so. But because at those low doses, D-cycloserine is a potent neuroplastic drug. In other words, it causes neurons, brain cells to scrap new dendrites and connect to other brain cells. And think of it as fertilizer in the field before you plant the seeds when you treat a patient with BCS and then do Transcranial Magnetic Stimulation on top of it.

So the Calgary study, which is published, there are 4 or 5 publications because they reported the depression effect, the suicidal effect and they've shown add-on effects in other diseases. Those are randomized controlled data. The real-world data that was published November 4 by folks associated with AMPA confirms that magnitude of effect. It's not randomized data, but they saw an 87% response rate when they combine a 1-day treatment protocol with D-cycloserine. Now the problem with D-cycloserine is the label stage, you can't use it for treatment of depression because it's well known to be hallucinogenic. And that's why we originally formulated NRX-101 and approached the FDA saying we'd like to have a form of cycloserine that can be used in patients with depression. And the FDA embraced that and gave us breakthrough therapy designation. So that's kind of how we got to here.

Would you like to restate the first part of the question?

Yes, that's really helpful. I was just wondering just regarding, I think there's a planned confirmatory Phase III trial for NRX-101 to augment effects of TMS, and I think it's planned for early 2026. I was just wondering if you work through any of the details for what that design may look like and if you can share those with us.

Yes. You can actually -- clinicaltrials.gov is a little bit behind in its work because of the government shutdown, but we've already filed that protocol, and you should be able to see it online before too long.

As you know, we've done protocols with NRX-101 versus lurasidone. This protocol is going to be NRX-101 versus placebo. But otherwise, it will follow the kinds of trials you've seen us do, where the primary endpoint is the MADRS scale, and we've demonstrated an ability to control our ratings to the point where there's less than 3 millimeters of drift. Between raters, the industry standard is to accept 6 points of drift, but we think that, that creates too much variance and harms the interpretability of a clinical trial.

We'll talk about it in future communications, but we've just licensed a very exciting technology from France that will put an app on people's cellphone that automatically measures depression levels from voice characteristics and facial characteristics that's already showing an 80% correlation with the MADRS. So we expect that this trial will be the first we run where we've got both objective and subjective measures of depression and suicidality.

The nice thing about this trial is you're talking about a day or a couple of days of D-cycloserine treatment rather than 6 weeks of treatment. So the risk that patients might not be compliant with the study drug dropped to near zero.

Thank you. And I'm showing no further questions at this time. I would like to turn it back to Dr. Jonathan Javitt for closing remarks.

So thank you all for joining us on short notice. As you know, we're enthusiastic about the FDA's determination that we've got a substantially complete ANDA filing. We look forward to working with the FDA over the next 6 months to bring this to market approval and to bring this medicine to patients.

It's been a great opportunity also to show you where our pipeline is expanding. And we look forward to continuing to deliver for our patients and our shareholders. Thank you all.

Thank you. And this concludes today's conference call. Thank you all for participating. You may now disconnect.

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals' Q3 2025 Earnings Conference Call. [Operator Instructions] This call is being recorded on Monday, November 17, 2025.

I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. 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 U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ 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 forward-looking statements. Information presented on this call is contained in the press release issued this morning and in the company's Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals, Inc. website.

Joining me on the call today are Dr. Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. We'll provide an overview of our company's progress as reported in today's 10-Q, following which Mike will give a review of the company's financials and results. Following their prepared results, we'll address investor questions.

Jonathan as having a couple of technical issues this morning, so I'll start us off. Since the beginning of the third quarter, NRx has made transformative progress in developing our business. We have advanced each of our programs with drug approvals applications in process for KETAFREE, NRX-100 and NRX-101. It also expanded our NRX-101 pipeline and closed on multiple acquisition targets for a network of interventional psychiatric clinics HOPE Therapeutics. In conjunction with closing our first clinics, we now are now generating revenue and on a path to a highly promising company.

The point of our call today is not 3 weeks of revenue from a single clinic just a few hundred thousand dollars that hit our third quarter income statement. Rather, it's the revolutionary and generational shift that we see in the treatment of severe depression and PTSD today, along with the potential to use the same technologies to treat traumatic brain injury, autism spectrum disorder, Parkinson's and even cognitive decline in coming years.

This past quarter has been a watershed moment in that generational shift from our perspective. Lastly, a group of highly respected scientists presented real-world data showing an 87% treatment response and 72% remission from severe depression following a single day of treatment with a newly developed TMS for transcranial magnetic stimulation and a low dose of D-cycloserine or DCS. Note that the active ingredient in NRX-101 is also DCS. This allocation comes on the heels of a well-controlled clinical trial in which DCS was shown to more than double the effect of conventional TMS in treating both depression and suicidality. Rather than rely on this call, we urge you to read the underlying science, referenced on our website on the Publications page.

As we announced last week, our company HOPE Therapeutics is the first one to deploy this ONE-D protocol in Florida in partnership with Ampa Health and we're actively partnering with its established clinics and seeking to open new clinics in Florida and nationwide. The scientists involved in that trial will be the first to say that there is not the only TMS machine capable of affecting a 1-day Theta-burst protocol. However, no drug other than DCS so far has demonstrated the augmentation of TMS in the literature.

Accordingly, this quarter's results should be viewed as seeing the first green shoots come out of the ground, not as an indication of whether these shoots will ultimately be a bush or a giant tree. We anticipate that our growing enterprise will be far easier to discern by our next conference call. As you know, we have been working with DCS since our founding in 2015, and our Co-Founder, Dr. Daniel Javed, began research with this class of compounds in 1987. NRx holds rights to more than 70 patents around the world that relate to the use of DCS in treating depression, PTSD and other life-changing brain disorders. We have extensive experience in the formulation and stabilization of this highly challenging and unstable molecule. A breakthrough therapy designation IND opened with the FDA and manufactured drug in our warehouse that is actively being deployed in an expanded access protocol to enable doctors to replicate last week's dramatic ONE-D findings.

Although a raft of compounding pharmacies are offering DCS for sale in response to these dramatic scientific results, we will be releasing chromatography and other foundational science demonstrating the need for manufacturing controls that are essential for preventing rapid degradation of DCS and the formation of various impurities, controls and techniques. We have devised over nearly 10 years of active preclinical and clinical development. The reason to be excited about combining DCS, which is a highly neuroplastic drug along with TMS, which is also a neuroplastic therapy, is not the simple notion that 2 neuroplastic treatments may be better than 1 as in one plus one equals to two. Rather, the scientific legacy of leaders in the field increasingly proves the drugs such as DCS, make the brain cells far more receptive to TMS and other neuroplastic therapies, akin to fertilize in the field as you plant the seeds.

For those who are new to this conversation, neuroplasticity is the process by which brain cells are constantly growing new connections to other brain cells. In a digital computer, transitors are always turning on and off under the control of software but the circuits stay the same. In the brain, those transistors are neurons, polarized and depolarizes, the cellular equivalent turning on and off, but also constantly form new connections and prune those connections to other cells. That's called neuroplasticity.

Over the past 20 years, we have come to understand that the loss of neuroplasticity in different parts of the brain is at the root of depression, PTSD, autism spectrum disorder and other conditions that I've mentioned. And Dr. Javitt's 45 year medical and scientific career, predominantly focused on the visual access of the brain, the last time he was involved in technological change that this profound was introduction of the first anti-VEGF drug to treat macular degeneration that led to a whole generation of injectable eye drugs that forever changed the potential for people to preserve their site in the face of previously hopeless and blinding conditions.

In our view, we are witnessing a similar tectonic split shift in the neuroplastic drugs, devices and digital therapeutics are being combined to transform the treatment of severe depression of PTSD today and the brain diseases that affect more than a billion people on the planet tomorrow. The dose publishing this science are correct, it is likely that oral antidepressant drugs with their life-threatening complications, their effects on disfiguring weight gain and sexual dysfunction, their propensity to cause suicidal ideation and their dismal 30% success rate may lose their places first-line treatment for those with life-threatening brain diseases.

More importantly, this generational shift in our understanding will finally cause us to abandon the notion of brain diseases that result in behavioral symptoms such as discretion and anxiety are biologically different for brain diseases that cause Parkinson's or cognitive dysfunction and that the patients who suffered these supposedly behavioral health problems are somehow less deserving of medical care than those who suffer from other neurological or CNS diseases. One reason we founded HOPE Therapeutics was to have the ability to directly engage the payer community in this changing paradigm. That brings us to corporate and financial results achieved in the past quarter and the objectives we think are meaningful over the coming quarters.

Our quarterly report reflects only the first 3 weeks of revenue from our first 2 clinics. By year-end, we anticipate growing from 2 clinics to 6 or more clinics within our current orbit, and we expect these revenues to demonstrate strong growth over the coming quarters as we integrate the clinics, help grow them and add to their numbers. Most importantly, the historic revenue is based on ketamine treatment sessions and traditional TMS treatment sessions that are generally reimbursed at less than $500 a session. Much of our future growth is likely to be focused on day and shrug shorter short-term multi-modality treatments with rapid clinical results that are already reimbursed by payers at higher levels.

To give you just one of many real-life illustrations of why this is economically viable, considering the situation of a highly trained essential first responder, who is suffering from depression and PTSD. In many cases, antidepressants are incompatible with a return to duty. For many frontline roles, this is a disqualification. Hence, the desire of the patient and the family for relief from a debilitating and life-threatening new addition aligns with the urgent need of military, law enforcement, emergency services and other organizations to maintain their force readiness. The financial and other resources -- financial and other resource costs of replacing frontline personnel is astronomical.

While medical insurance decisions are often made by the executives who many Americans view as not caring enough about the individual, health insurance payment policies are increasingly dictated by the employers who pay the premiums and who care deeply about their ability to maintain a workforce in whom they have invested. Often the decision makers at that level are the military leaders, police and fire commissioners and others who have come up through the ranks and we think about their people first.

When Dr. Javitt presented last month at Fort Belvoir to a room containing generals, admiral and elected officials. He sat with a senior adviser to the Secretary of the Veteran Affairs Administration who reminded of the public statements from the VA that stopping veteran suicide is in their -- is their top priority. We hope to release a video of that briefing to you in the coming weeks.

Our balance sheet is considerably stronger than it was at the end of the second quarter, owing in part to the support of long-term health care specialist investors who joined us during the third quarter and purchased common stock with no warrant overhang, no pricing provisions and no convertible debt feature. At this point, NRx has secured operating capital that is anticipated to be sufficient to fund drug development operations through 2026. Additionally, as just noted, we expect to continue to add revenue from the clinical operations and believe it is likely that we will see revenue from sales of ketamine under an ANDA in mid-2026.

As you can see from our balance sheet, and as Mike Abrams will be discussing in greater detail later, we are well positioned to achieve numerous milestones on both sides of our business with existing cash. Our goal in doing so is to substantially enhance shareholder value while advancing our mission of bringing HOPE to life.

Now let's review each program, starting with our preservative free ketamine -- which was previously required a toxic preservative, which is benzethonium chloride to maintain stability and sterility. Our stability data remains on track for a 3-year room temperature shelf life. We're pursuing 2 parallel approval processes, a generic pathway and an innovative pathway using 2 different formulations to prevent price confusion. As you saw in August, FDA ruled that those 2 formulations create 2 different drug identities. The first pathway is a new drug application or NDA for NRX-100 in suicidal ideation for patients with depression, including bipolar depression.

The second is an abbreviated new drug application or ANDA to make KETAFREE available for ketamine's existing generic indications. NDA preparation is nearly complete, and we anticipate transmitting the entire submission in the coming weeks. The key development is that we are adding more than 60,000 patient encounters of real-world efficacy data, which demonstrates statistically significant advantages of intravenous ketamine over nasal S-ketamine. Combined with the data from U.S. and European trials in more than 1,000 patient participants, we believe this to be a compelling case for efficacy. This will be an important step forward for both the company and for patients suffering from suicidal depression.

There's currently no medication approved for treating suicidal ideation and the SPRAVATO label clearly states that it has not been shown to be effective for reducing suicidality. The only current alternative is for patients with suicidal ideation is ECT or electroconvulsive therapy. As you know, the PCORI trial, which is posted on our website, demonstrated a 30% incidence of memory loss with ECT and none with IV ketamine. And what we feel is a strong validation the FDA granted to us and expand Fast Track designation in August to now include all patients with suicidal ideation and depression, including bipolar depression.

Suicidality is a massive problem in the U.S. The fact -- in fact, the CDC estimates that nearly 13 million Americans seriously consider suicide each year, and this leads to an American dying from suicide every 11 minutes. Our leadership team was invited to Fort Belvoir last month where we presented to senior military and veterans affairs leaders and will be repeating the briefing at VA headquarters and Nellis Air Force base to the Air Force leadership. As Secretary Collins has said publicly stopping veterans suicide is his top priority.

In June, the FDA created the commissioner's national priority voucher program that affords substantially faster review times of 1 to 2 months versus the standard 10- to 12-month review, enhanced communication throughout the review process and creates potential for accelerated approval of NRX-100. Commissioner Macri has publicly stated the safe and effective drugs to prevent suicide are a top priority for him. More importantly, after some publicly reported personnel changes, the FDA centers for drugs now as a leader has been long-term proponent of accelerated approval for life-saving drugs that meet an unmet medical need. To receive a CNPV, a product must meet at least one of the following criteria: address the U.S. public health crisis, address a large unmet medical need, deliver more innovative cures for the American people, reassure key strategic drugs to the U.S. or reduce health care costs. NRx meets all of these criteria.

In Q3, we filed an abbreviated new drug application for ketamine with priority review requested. We call this product KETAFREE. After meeting with the FDA in August of 2025, we've refiled the ANDA following FDA notification of the suitability position for NRx's proposed strength of KETAFREE. Last week, we received a communication from FDA, noting no significant deficiencies in the revised KETAFREE filing, and we believe the filing is on track for second quarter PDUFA date or generic -- that's a generic drug equivalent of a PDUFA date.

The company has additionally submitted a citizen petition seeking to have benzethonium chloride, a toxic preservative included in all currently approved ketamine products for antiquated reasons, removed from all presentations of ketamine. This preservative is the subject of a detailed toxicology report we have published, which details the concerns that led FDA to ban BZT from topical antiseptics and hand cleansers.

Notably, benzethonium chloride does not categorized by FDA as GRAS or generally recognized as safe. This report has been submitted to the FDA in support of our citizen petition. As a preservative-free formulation ketamine is an important invention, we have filed a patent application with the U.S. patent in the Tradmark office to protect our intellectual properties surrounding this product. The existing generic market for ketamine has been projected at approximately $750 million. And we believe KETAFREE made in the U.S. and often without any toxic preservatives offers patients and clinicians a superior option.

We'll continue to work diligently with the FDA to move our application forward as rapidly as possible and provide a safer version of this critical product to the American public. Our program around NRX-101, our oral combination of D-cycloserine and lurasidone took an extremely positive and unanticipated direction as outlined in the opening. As you know, we received breakthrough therapy designation for this drug in the treatment of suicidal bipolar depression and continue to advance that agenda. Our manufacturing data is on file with stability trending towards 5 years, and we have 1 million doses in the warehouse.

There are more than 7 million patients suffering from bipolar depression in the U.S., and many of these are at risk of akathisia, a terrible side effect caused by serotonin active or SSRI drugs that is closely related to suicide. These patients are a tremendous risk of self harm. We have demonstrated statistically significant superiority of NRX-101 over lurasidone to this current standard of care in reducing suicidality and akathisia in 2 well-controlled trials. Both NRX-101 and lurasidone are potent antidepressants and one of those trials also demonstrated superiority in reducing depression. Remember that we are comparing to a known effective drug, not placebo.

Because of the huge unmet need, we are optimistic that FDA will be receptive to an application for accelerated approval in the 600,000 patients who suffer from suicidal ideation in bipolar depression, despite treatment with a currently approved medication. A few days ago, a new Director of the FDA Center for drugs was appointed who pioneered the accelerated approval pathway and has been a staunch to advocate for early approval of medicines for life-threatening conditions for which there is no currently available therapy.

Last week, we saw a publication of the exciting and unanticipated finding that low-dose D-cycloserine, again, the active ingredient in NRX-101, when combined with a ONE-D protocol of TMS. Recently, there's been exceptional interest in the use of DCS, the active component to enhance the efficacy in the treatment of depression. D-cycloserine, like ketamine, blocks the NMDA receptor and enhances neuroplasticity. Recently published real-world data provides confirmatory evidence seen in a prior randomized controlled trial that low-dose DCS more than doubles the antidepressant effect and anti-suicidal effect of TMS.

Unfortunately, DCS alone is contraindicated in patients with depression, which may impact willingness of patients and practitioners to use this new protocol. Importantly, NRX-101 while including DSCS in its formulation, does not carry this contraindication. As the addition lurasidone blocks the effect of the NMDA inhibition in one key side effect. This creates a significant need for development of NRX-101 for the use of -- in conjunction with TMS to treat depression, PTSD and other disorders. We have more than 25,000 manufactured doses of NRX-101 at the appropriate strength on hand and launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under expanded access and federal right to try laws. A confirmatory Phase 3 trial of NRX-101 to augment the effects of TMS is planned for early 2026. The market estimate for this newly validated indication for NRX-101 is in excess of $1 billion.

On September 8, 2025, HOPE Therapeutics initiated revenue generation upon closing of its acquisition of Dura Medical clinics located in Naples and Fort Myers, Florida. HOPE subsequently added Cohen and associates in Sarasota, Florida, another revenue-generating EBITDA-positive clinic to the HOPE network. Dr. Rebecca Cohen, Founder of Cohen and associates has been appointed as HOPE's Medical Director. Last week, HOPE was the first organization in Florida to launch 1-day TMS treatment for severe depression and ONE-D protocol using the Ampa TMS device. The ONE-D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at 6 weeks.

Following a single day of TMS treatment combined with D-cycloserine, focus in the process of adding 3 more facilities this year and is in an active discussion with numerous acquisition opportunities around the country. With our significant advances in the third quarter and a committed investor base, we believe we are better positioned than ever in our history to build shareholder value and to address the national crisis of suicide. We will do everything in our power to continue bringing HOPE to life.

With that, I'll turn it over to Michael Abrams, our CFO, to review our financial results for the third quarter. Mike?

Thank you, Matt. For the 3 months ended September 30, 2025, the company reported a loss of operations of $4 million versus a loss from operations of $3 million for the comparable quarter in 2024, the difference is primarily attributable to $800,000 of additional research and development expenses to support our FDA initiatives for NRX-100 and NRX-101, including the previously discussed and submission for preservative-free IV ketamine, and $400,000 of additional general and administrative expense which included our efforts to close, operate and identify clinic acquisition targets for HOPE.

As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents Including approximately $3.1 million from a subscription receivable for which the company received the cash in early October, total cash as of September 30, 2025, would have been $10.3 million. For the third quarter ended September 30, 2025, the company reported revenue for the first time in its history, driven by the acquisition of Dura Medical, which closed September 8.

While revenue of approximately $240,000 was relatively modest, it reflects 22 days of the full quarter in a single clinic group. Management anticipates the ability to include results for the full period for during and future quarters closing anticipated additional acquisitions and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a noncontrolling interest are expected to improve our overall financial position, but not directly increase revenue.

Finally, we remain in active discussions with several additional potential acquisition candidates and while no assurances can be given that we will close any or all of such opportunities, together, they represent total revenue of more than $20 million on an annual basis. The company believes that its current cash position will support operations at least through the second quarter of 2026 as well as provide sufficient capital to expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of HOPE clinics. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders.

With that...

Thank you, Mike, and thank you guys for sparing my voice this morning. I look forward to taking questions.

Operator, I believe we can begin to take questions.

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

I have a couple of questions on this remarkable DCS result with TMS. Historically, is it clear that DCS is much better than Ketamine in this position? Is this truly unique to the drug? Or is it a general combination effect.

And then can you give us a sense of how you would use 101 in this procedure? I assume it's not a hard co-formulation that your 101 is simply available. But how cumbersome is it to add a drug, your DCS -- and can you get paid for it? Just some logistics. I know you have a lot of drug. It looks like it's exciting. Can you guys run us through the steps to actually use it?

Those are great questions. And a lot of this work, the basic science work has been done and published by Dr. Josh Brown at Harvard McLean with a number of others supporting the science. The most important thing to recognize is that DCS has to be used at a non NMDA antagonist dose. And I know this is a little more science than we sometimes do on a conference call. But in this case, it's critical. DCS is what's called a mixed agonist antagonist, unlike ketamine, unlike [indiscernible] unlike all of the NMDA drugs that blocks the NMDA channel, DCS affects a side unit of NMDA called the glycine site and at low doses, it's actually an NMDA agonist, but much more importantly, it's a highly neuroplastic drug.

There's evidence that ketamine plus TMS actually decreases the effectiveness of TMS, there are even people who believe that ketamine shouldn't be used in conjunction with electroshock therapy because it may decrease the effectiveness of electroshock therapy. So all of the work that's been done is at low doses of D-cycloserine, 150, 175-milligram dose and it just happens that when we formulated NRX-101, that was one of the strengths that we made. That's why we have it in the warehouse. In fact, it was not made to be the main strength of NRX-101, it was manufactured to be a potential step-down strength in our clinical trial. So far, nobody else has identified a different neuroplastic drug that works in combination with TMS, the way D-cycloserine does.

Do me a favor and repeat the second part of your question where you were asking...

Just the procedure to use your drug because it's in the works at the FDA, what would be -- how hard is it to just for somebody to get your drug if they want to add it to TMS in your clinic or anywhere else?

Well, we have an expanded access protocol for DCS under the laws than required to be made available for expanded access. So if somebody writes to us, we're happy to provide it for this purpose as long as they provide us with the data of what happened. ClinicalTrials.gov has been a little backed up because of the government shutdown. But as ClinicalTrials.gov catches up, you'll see those expanded access protocols for DCS and TMS showing up online.

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

NRX-100 and suicidal depression, the FDA has identified no significant deficiencies to date. I'm wondering, first, what feedback have you received on the accelerated approval strategy. Secondly, do you still anticipate a year-end PDUFA decision? And separately, when do you anticipate learning if the CNPV is granted and what impact that could have on the PDUFA?

Well, as we've said, we're in the CNPV process, and therefore, the NDA under Fast Track designation for NRX-101 has not been filed in its totality yet. We've said that several times, we're expecting to be heard about the CNPV this year. And the main advances with that NDA are that we now have access to the real-world data that we believe massively augment the filing that we will make under accelerated approval once we learn whether we're doing it under CNPV or not, where we're expecting not only to file the original clinical trials that we've told people about, but more than 60,000 patients worth of real-world data as well that we believe provide a solid case for accelerated approval.

Right. And with the Citizen Petition now filed to remove benzethonium chloride, can you discuss how this regulatory action could reshape the market for IV ketamine and how you would ensure adequate domestic supply if the FDA moves to ban this preservative-containing formulations?

Yes. This is actually the first ketamine that's packaged in what's called a Blow-Fill-Seal presentation where instead of a glass bottle. The machinery takes a drop of polyester resin heats it up, blows it into a container, fills it and puts it out at the back of the assembly line completely packaged and ready to ship. It takes your production capacity from a couple of hundred thousand bottles a month to 1 million or more bottles a month per assembly line, and therefore, if we had to, we could supply every vial that's required for ketamine in the United States at that kind of manufacturing capacity. Everything else that's coming in for ketamine is glass vials.

Right. And just one maybe on HOPE. The ONE-D protocol combines TMS and DCS and it shows a rapid onset of antidepression effects. I'm just wondering how you'll be positioning HOPE to become an early adopter in data generator for that combined treatment pathways? And as well just separately, assuming the approval of NRX-100 and NRX-101, how will you integrate those treatments into the HOPE care model once they're approved, assuming they are approved?

Well, those are 2 fantastic questions. And the ONE-D protocol is legal under the medical device laws. The coil that was used was manufactured by a company called Ampa, which has some very exciting technology not only in terms of their pioneering of the ONE-D protocol, but in terms of having built the first portable TMS one that can be taken to nursing homes, extended living facilities, you could even do it in a firehouse because it fits in 2 Pelican cases. We announced last week that we partnered with Ampa that we are the first site in Florida to be doing the ONE-D protocol, so it's readily deployable. Now it's not specific only to that machine, but all of the ONE-D results so far that have been reported have been reported on that machine.

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

Yes. Congratulations on all the progress. As NRX-100 and 101 have potential approval dates relative within the next year, hopefully, or much sooner than that? Have we talked about your clinical or commercialization strategy for both?

Ed I'd like to listen to that question again.

Sure. Have you talked about your commercial strategy? Will you need to have a sales force to market NRX-100 and 101 when you get approval?

Well, they're very different drugs and they will need different strategies. So NRX-100, we're talking about a drug that can only be deployed in a clinic setting by a physician who and we anticipate that there will be a REMS of some sort in the same way that there's a REMS for SPRAVATO. So the NRX-100 project, the preservative-free ketamine project is very much something that a company of our size can undertake. You talking about much more of what's called a medical science liaison function than a sales function because physicians who are treating with ketamine in their office, know that they want to do that and what they need is medical liaison support. It's not traditional pharmaceutical detailing.

NRX-101 we're seeking an indication where we want to treat people with severe bipolar depression who have suicidal ideation despite having been treated with best available therapy. So if you take a look at the people who are currently prescribing drugs like lurasidone to treat bipolar depression, there are approximately 1,600 doctors like that in the United States. Many physicians don't want to be treating suicidal bipolar patients. So that's actually a sales force also that a company like ours could build, we anticipate it's a requirement of about 50 salespeople. We've talked to larger commercial partners in the past about NRX-101, and it's possible that we would partner with a larger commercial partner. But bottom line, NRX-100 is within our launch capabilities. NRX-101 is still within our launch capabilities, but we know that there is significant interest from larger partners.

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

Thank you, everyone, for joining us this morning. We're extremely excited about the path ahead with 3 potential drug approvals in the subsidiary targeting multiple profitable metal health clinics as well as our new indication with NRX-101. This concludes the NRx Pharmaceuticals Third Quarter 2025 Results Conference Call. Thank you all 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.