NRXP - NASDAQ

Good morning, ladies and gentlemen. Welcome to NRx Pharmaceuticals Q2 2025 Earnings Conference Call. [Operator Instructions] This call is being recorded on Wednesday, August 20, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead, sir.

Thank you, Ludy. 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 vary 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 Monday and in the company's Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals Inc. website. Joining me today on the call are Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in Monday's 10-Q following which Mike will review the company's financial results. Following their prepared remarks, we will address investor questions. I'll now turn it over to call to Jonathan. Jonathan?

Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exception for NRx. We've made vital advances across each of our programs with 3 drug approval applications in progress and our evolving network of interventional psychiatry clinics Hope Therapeutics taking place. At the same time, as we position for near-term revenue, we've reduced our quarterly operating loss by approximately 50% year-over-year while filing more than 80,000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists. As we announced on Monday, we've strengthened our balance sheet and added long-term health care specialist investors with extensive experience in biotechnology as well as experience in managing multiunit retail operations led by [ Mr. Brandon Mall ] and the B Group. These investors have demonstrated their long-term commitment to our success by way of their 1-year lockup agreement not to trade short or otherwise hypothecate our stock while also forgoing warrants and other dilutive features that are so obstructive to biotechnology stocks today. We at NRx look forward to their ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO in order to create a more straightforward growth path for long-term appreciation oriented investors. Let me start with a high-level overview for each program, starting with NRX-100. Our preservative-free intravenous ketamine is following 2 parallel approval processes. First, however, let me take a moment to explain how this came about. As many of you know, my original medical discipline is ophthalmology. And for 10 years, I cared for patients with chronic glaucoma first at Johns Hopkins and then at Georgetown Universities. Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients. The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. And the problem was compounded by the presence of benzalkonium chloride in the artificial tear drops that were used to try to help the dry eye that was caused by the glaucoma drops in the first place. Clear evidence emerged that benzalkonium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea. That's why so many eye drops have gone preservative free over the years. Well, the first cousins of benzalkonium chloride, benzethonium chloride or B

Thank you, Jonathan. For the first -- for the 3 months ended June 30, 2025, the company reported a net loss of $17.5 million versus a net loss of $7.9 million for the comparable quarter in 2024. The increase in the net loss was driven by an approximately $12 million charge in fair value accounting measurements related to previously issued convertible notes and warrants recorded in other expense, all of which is noncash. For the 3 months ended June 30, 2025, the company reported a loss from operations, which excludes the noncash impact of fair value accounting measurements of $3.7 million versus a loss from operations of $7.1 million for the comparable quarter in 2024. This marks an improvement of more than $3.3 million or 47% compared to the prior comparable quarter. As of June 30, 2025, NRx had approximately $2.9 million in cash and cash equivalents. On August 18, 2025, the company closed a registered direct offering with a select group of experienced long-term health care and biotechnology investors, led by B Group Capital. In connection with that offering, the company issued approximately 3.9 million shares of common stock and received net proceeds of approximately $6.5 million. The shares issued in the offering are subject to a 1-year lockup and the terms of the offering did not include warrants, pricing resets or any other structured elements. The company did not use a broker or investment bank in connection with the offering. The company believes that its current cash position will support operations well into 2026 and provide sufficient capital to reach critical and anticipated regulatory inflection points and milestones. 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 turn the call back over to Jon. Jon?

Thank you, Mike. As you can see, the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors. Our goal of bringing hope to life is closer than ever. Our progress towards 3 potential drug approvals in the near-term and continuing the development of Hope Therapeutics national network for care delivery, our transformative steps for the company and for the treatment of mental health in the United States. I would like to thank the NRx team, our long-time and new investors and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. Operator, we're ready to take questions from the audience.

[Operator Instructions] With that, our first question comes from the line of Tom Shrader with BTIG.

And it really has been a lot of progress this quarter. I have a couple of quick ones. For 101, why is the pathway accelerated approval? It seems like you have very conventional clinical end points that you kind of argue you've hit and I think have accelerated approval for more biomarker-type trials. And a quick 1 on the new voucher. It looks like it's even more valuable than the older pediatric voucher. Is it clear it can be sold the way the other vouchers were? Has that been defined yet?

Well, let me start with the second question first. I think the agency has been clear that the CNPV's are not to be sold. And certainly, we would have no interest in selling a Commissioner's National Priority Voucher where we -- to be awarded one. Our sole objective is to get this drug to patients as a life-saving drug for a critical unmet medical need as quickly as humanly possible. That's the objective of the commissioner's program, and that's the objective of NRx. As far as accelerated approval for NRX-101, as you recall, the primary endpoint of the clinical trial that we conducted was reduction in depression compared to lurasidone alone. And secondary endpoint was reduction in suicidality and akathisia as separate named endpoints. The clinical trial did not demonstrate that NRX-101 is a superior antidepressant to a very well-established antidepressant namely lurasidone, but did demonstrate reductions in akathisia and suicidality. And we believe that those are intermediate endpoints and that they haven't necessarily been demonstrated to be associated with long-term health benefits. So for that reason, we think the appropriate thing to do is ask for accelerated approval only for use in those patients who have demonstrated akathisia and suicidality despite best available medicine. In other words, for patients where there's truly an unmet medical need and an immediate risk of harm to the patient in the absence of treatment for those conditions and to ask FDA to give us 5 years in which to demonstrate that NRX-101 has a conventional long-term benefit compared to placebo.

Just to follow up, what would the second trial or the follow-up trial, confirmatory trial look like? Do you have any sense?

Yes. The confirmatory trial, if you look at the approval path of Auvelity, for instance, the confirmatory trial would be a very conventional randomized controlled trial of NRX-101 versus placebo with depression on the MADRS as primary endpoint because that's the endpoint that FDA has really set as the bar for all antidepressant drugs.

And your next question comes from the line of Jason Kolbert with D. Boral Capital.

Again, congratulations on all the progress. Can we talk a little bit about some expense guidance. And I'm not really talking about third quarter or fourth quarter. But just from a big picture point of view, R&D is that likely to ramp up in the future? Should we see it at about the same level? And G&A, as you become a commercial entity, how do you envision G&A expanding? And I also have some questions about the acquisition pipeline associated with the clinics.

Mike, Please go ahead.

Okay. Sorry. So I'll -- from a financial perspective, Jason, thank you for your question. Obviously, as you know, we don't give guidance. So I think the best proxy for our financial statements and our trends and the expectations is what's reported in the 10-Q. And this is where it's very notable. We talked about we had approximately 50% reduction, 47%, almost 50% reduction in our loss of operations. And so as a pre-revenue company, that is entirely made up of G&A expense and R&D expense. And so the decline from $7 million to $3 million change is as a direct result of internal budgeting and cost-saving measures that we continue to execute on. And again, not to get clouded with the net loss that was reported because that involves fair value accounting, which some people call derivative liability accounting, which could be quite counterintuitive in its impact on the income statement and the balance sheet, whereby an increase in our stock price makes it look like an increased liability, increased expense, but those are all noncash. So really looking at loss from operations, I think, is the cleaner view into our financial picture. And the trends of reducing our overall operating costs comprised of G&A and R&D are evident, and we believe to be continued. Again, not prepared to give guidance on where that may go in the future. But we announced it and discussed it because we think it's a worthy note of our financial statements that investors can -- should take note of. With that, I'll turn it back over to Jon.

I can appreciate your comments, but the expectation is that we would see G&A ramping up as you become a commercial entity, but we'll I think what you're saying is tempor -- expense ramp up with the strength of the balance sheet so that kind of comes together and sync. That's how I interpret what you're saying.

Well, yes, just a follow-up on that. The -- any increase in G&A that is sometimes seen in these situations as commercialization comes also comes in line with revenue, right? So we are -- we have been managing the business for what it is now. As Jonathan mentioned in his comments during the call, we believe we're relatively near-term commercialization and in advanced all of our drug programs as well as opportunities with Hope Therapeutics. So as revenue comes on, we -- management will continue to assess those and make decisions. But the timing of which I don't want to provide forward-looking statements on or provide projections on what that revenue flow will look like. But any increase in expense related to commercialization will be taken part and parcel simultaneous with the revenue itself. So -- but your point is noted.

Typically, Jason, a question like that is going to get plugged into a model that ultimately projects a price per share for a company such as ours. And you're asking in a very legitimate way. Do we think our G&A may increase as we get forward to actually -- as we get closer to selling a drug. And although that answer might well be yes, by the time we do that, our probability of success in any such model will have substantially increased. So that the projected increased costs of G&A will be closely tied to an increased probability of corporate success.

And Jonathan, how about the acquisition pipeline in terms of clinics -- and can you give any kind of idea of what you might look at -- I mean, from a big picture point of view, 5 years from now, what do you think your footprint looks like?

Well, 5 years from now, if we're successful in what we aim to do with Hope Therapeutics, First of all, it will almost certainly be an independent company from NRx Pharmaceuticals. And the companies that we would hope people would look at are companies like DaVita and Fresenius that transformed the dialysis industry from disparate clinics where it was almost impossible for a consumer to know what kind of quality to expect to coherent networks of care delivery organizations where consumers had a reasonable expectation of consistent quality, consistent outcomes across the network. And investors enjoyed extraordinary financial success in the process. So our challenge is finding best-of-breed clinics that have really integrated the use of neuroplastic drugs, and this is a word you'll hear us using more and more. People talk about psychedelic therapy as if the hallucinations that are induced have something to do with the medical benefit. And they may. But in our view, what's really going on is that this class of drugs causes the brain cells to form new connections to other brain cells. That's a process called neuroplasticity. If you want to make a computer chip, you take a piece of silicon and you etch it with a laser, you may use programming to turn circuits on and off, but the circuits on the chip will be there for the end of time. The brain works completely differently. Brain cells are constantly branching, making new connections to other brain cells, pruning those connections and the evidence is that when that process of neuroplasticity stops, that's when you have severe depression, you have suicidality. And all of these drugs that are showing benefit are doing so in our view and in the evolving view of many of the scientists we talk to because they're causing neuroplasticity. So how do you do that? You can do it with ketamine and related drugs. There's evidence you can do it with the Psilocybin class of drugs, what people call the psychedelics. There are drugs over the horizon that achieved neuroplasticity without the hallucinations. You can achieve it with a treatment called transcranial magnetic stimulation, which is FDA approved, you put powerful electromagnets outside the head, and achieve profound changes on depression, on suicidality. There's emerging evidence that may work for autism for PTSD. And people are seeing benefits with hyperbaric oxygen therapy. I'm sure there will be other neuroplastic therapies coming down the pipe. Our objective with Hope Therapeutics is to identify best-in-class clinics that are already combining those treatments. The notion of a ketamine clinic where you can get IV ketamine on Mondays and peptides on Tuesdays and vitamins on Wednesdays, that's the opposite of what we think patients need. So we may be able to identify $100 million of acquisition of that kind of best-in- breed clinic. But very quickly, you'll see Hope shifting to a model of building clinics from the ground up to extend those flagship clinics that we acquire on day 1 because we don't think we can grow beyond $100 million or so just by acquiring clinics that already exist. So it's hard enough to talk about what we'll do next year versus 5 years from now. But I think 5 years from now, you're going to see a national network in place such that patients and families who are suffering from these conditions know to pick up the phone, call Hope Therapeutics and expect to have a life-changing opportunity to get better.

And your next question comes from the line of Patrick Trucchio with HC Wainwright.

Congrats on all the progress advancing NRX-100, NRX-101 and the Hope platform. It's clear the team has made meaningful strides on both clinical and regulatory fronts. And we have a few follow-up questions. The first is just on the citizen petition impact. You've explained the scientific basis for the citizen petition on benzethonium chloride. I'm wondering if you can give us a sense of when you may expect an FDA response. And from a commercial perspective, if the FDA were to mandate preservative-free formulation across ketamine, how meaningful could that revenue uplift be for NRX-100? And how challenging might it be for existing suppliers to adjust?

Well, the FDA's requirement is to respond to a citizen's petition within 6 months of filing. And we hope that FDA will beat that requirement. Certainly, we have a Secretary of Health and Human Services. Mr. Kennedy, who has demonstrated a profound dislike for both artificial colors and preservatives in foods, in drugs, who clearly recognizes that many of the things we've assumed to be safe, unless proven safe may not be safe. And in this particular case, we're talking about a preservative that's toxic to the point where FDA won't even allow you to put it into a hand cleaner or topical antiseptic. So they know a lot about benzethonium chloride maybe even more than we do. In terms of impact, right now, the generic ketamine market is $750 million a year. It's mostly foreign sourced goods. From what we've seen, and we haven't gotten other people's products into the laboratory measured ourselves, that level of B

That's really helpful. And just another follow-up on NRX-100. I think you mentioned plans to submit real-world data from nearly 180,000 patients treated with ketamine and SPRAVATO. I'm wondering how you expect the FDA to weigh this data set alongside the randomized controlled trials? And do you believe it could further strengthen the case for an accelerated approval?

Well, we think real-world data in that quantity of patients certainly should motivate FDA to see the case has substantially strengthened the FDA guidance is that the agency really needs to pay attention to real-world data. And Commissioner Makary has said very clearly that he wants to move the agency solidly into the 21st century in terms of using real-world data. So we hope this will be one of the first examples where real-world data supports an approval. It's very rare to have a drug approval coming down the pike where more than 200,000 people have already gotten the drug for this purpose. It just doesn't happen to be approved for this purpose yet. It's a unique circumstance.

Yes. That's interesting. And then just on NRX-101, an interesting highlight of the potential synergy between NRX-101 and TMS. And I'm wondering if this combination could it accelerate adoption either within the Hope clinics or across interventional psychiatry more broadly? And is this something that you may seek a label expansion to more formally capture this potential.

Thank you. You're asking a fascinating question. And we've identified a very provocative -- in a good way, provocative scientific study that was performed out of Canada, where investigators showed that NRX-101, well, they specifically showed that D-cycloserine the main active ingredient in NRX-101 compared to placebo, enhanced the effect of transcranial magnetic stimulation or TMS in treating depression. And they didn't really give an antidepressant dose of D-cycloserine. They gave about 100 milligrams per patient per day which was a lower dose than would be needed to block the NMDA receptor. As you recall, my brother, Dan Javitt has done most of the work as supported by patents all over the world in demonstrating that you have to get to about 400 to 500 milligrams a day of D-cycloserine before the drug becomes a potent NMDA antagonist. So they used a much lower dose of D-cycloserine. They used 100 milligrams a day which is believed to be neuroplastic even if it's not a potent NMDA antagonist at those doses. And lo and behold showed a very potent improvement in the results achieved with transcranial magnetic stimulation. So we're in active discussion with U.S. academic medical centers about mounting a confirmatory clinical trial in that area. It would be a very interesting label expansion for NRX-101, but more importantly, if that drug is able to potentiate the effect of TMS, it will bring TMS in our estimate, much more into the mainstream as maybe even a first-line treatment for depression rather than starting out with these old generic serotonin drugs that may or may not work depending on who you read. And certainly, every one of them has a label that says, caution, this drug may be associated with increased levels of suicidal ideation. So anything that leads to better outcomes from TMS, anything that makes that treatment more accessible and more potent for patients has the potential to really shift the whole paradigm of how we treat suicidal depression, even ordinary depression and PTSD.

And your next question comes from the line of Ed Woo with Ascendiant Capital.

Yes. Congratulations on all the progress. What is your commercial strategy with NRX-100, now 101? Are you going to wait until closer to approval to actually expand and potentially get a sales force?

Yes, it's a wonderful question. And Matt Duffy is on the phone with us. A lot of people know Matt in his role within our company as our Chief Business Officer. People have known Matt in his role at -- on Wall Street as a highly respected research analyst. What fewer people know is that Matt got out of college, joined Pfizer, succeeded in a commercial role to the point where he actually wound up as the product manager for Viagra and went on to launch highly successful biologics at other companies. So Matt, why don't you walk Ed through what you'd be likely to do if we drop the drug approval in your lab?

Sure. Thanks for the question, Ed. Good to hear from you. So we've done launches like this. I've done a few of them. The MedImmune is probably the most notable, but also at Lev Pharma, where it's a pretty focused launch for both of these drugs. It would be different with different targets. If you think of NRX-100, you think of the clinics like we have with Hope and other mental health facilities. There's probably 600 to 1,000 that are really solid places that will administer these medications. At this point, that will grow once you have a reimbursed product. But when you start looking at those numbers and thinking about what a rep or an MSL or a business person and administrative person might be able to do. You probably can get away and really be successful with a small commercial force. I think at MedImmune, our initial group of reps and MSLs is about 20 people. And that was a very focused group of focusing about 500 hospitals. And then at Lev it was a similar situation with individual rheumatologists that we were targeting. And so for NRX-100 you probably launched with around 20 people, and you can do the math on what MSLs and reps cost these days and really do a good job really covering the key players in the market and really getting good coverage over a huge proportion of what we really think is the opportunity in the mental health side for ketamine and NRX-100. It's going to be kind of similar with NRX-101, but look different. There are -- there is a very focused number of perhaps -- I think the number is about 1,500 to 1,600 maximum psychiatrists who treat bipolar patients. Those numbers are a little dated from market research we did a few years ago. But if you do the math backwards in terms of rep coverage and MSL coverage for that, it's a similar number of patients -- I'm sorry, of field personnel. Those folks may be a little bit more expensive because you may have a little bigger tilt towards MSLs. But if you can cover 1,500 high-prescribing bipolar psychiatrists with not that many reps. And so those are pretty focused efforts and then the marketing behind it, therefore, is more focused as well. So I think these are 2 really focused launches. They can be synergistic because of the knowledge base of bipolar depression and major depression and suicidality for both will have a lot of overlap. But as you look at those, the company will obviously get smarter and smarter on the commercial side as we're getting closer and as we're launching the products. But you're probably talking about two 20, 25-person commercial organizations with the supporting infrastructure. It's really focused. We did it with not a lot of money at MedImmune, and they did it with not a lot of money at Lev and then when ViroPharma bought us shortly thereafter. And so it can really focused and it can be a very efficient launch. And the nice thing about that is you hit profitability much, much, much more quickly. And if you have a 500-person primary care sales force like Pfizer, we would launch with at Pfizer.

And we have no further questions over the phone lines. I would like to turn it back to Matthew Duffy for closing remarks.