NRx Pharmaceuticals narrows operating loss by 50%, targeting FDA approvals for NRX100 and NRX101 while expanding Hope Therapeutics clinic network.

Sam - (00:00:32)

Sam Good morning ladies and gentlemen. Welcome to NRx Pharmaceuticals Q2 2025 earnings conference call. At this time all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. 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.

Matthew Duffy - Chief Business Officer - (00:01:32)

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 US Federal SECurity 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 here 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 10Q which may be accessed from the investor 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 10Q, following which Mike will review the Company's financial results. Following their prepared remarks, we will address investor questions. Now turn the call over to Jonathan.

Jonathan Javitt - Founder, Chairman, and CEO - (00:02:48)

Jonathan thank you Matt. Good morning everyone and thank you for joining us. The past several months have been nothing short of exceptional for NRX. We've made vital advances across each of our programs with free 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 healthcare specialist investors with extensive experience in biotechnology as well as experience in managing multi unit retail operations. Led by Mr. Brandon Mull and the B Group, these investors have demonstrated their long term commitment to our success by way of their one year lockup agreement not to trade short or otherwise hypothecate our stock while also foregoing warrants and other dilutive features. That are so destructive 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 the 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 NRX100. Our preservative free intravenous ketamine is following two 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 University. 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 teardrops 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 to the nerves of the cornea. That's why so many eye drops have gone preservative free over the years. Well, the first cousin to benzalkonium chloride, benzethonium chloride or bzt, is found in ketamine. BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70 years ago so that the same vial of drug could be used for multiple doses of drug without contaminating the bottle. In today's hospital environment, multi dose administration is increasingly infrequent. The BZT and ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia. The problem is patients who get ketamine for depression often get repeated administrations, as we have shown the FDA in our citizen's petition. And as you can see from the scientific paper identified in the Q and the earnings release, multiple doses of ketamine with BZT, preservatives can approach toxic doses of bzt. That's why we filed the citizen's petition with FDA to have BZT removed from all forms of ketamine. Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe is not on the list of preservatives generally recognized by as safe. That's called the grass list by the FDA. Indeed, FDA's concerns about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly. As I said, we're following two regulatory paths for ketamine. The first 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 preservative free ketamine available for ketamine's existing indications. Data are clear in our view that NRX100 can offer effective and safe options for patients with suicidal depression whose only current treatment alternative is Electroconvulsive Therapy (ECT) or Electroconvulsive Therapy. Our corporate presentations highlight randomized controlled trials demonstrating superiority of ketamine to placebo to active comparator, along with demonstration of equivalence to Electroconvulsive Therapy (ECT) overall in more than 1,000 patients. We'll be presenting real world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and Spravato. We aim to submit these data in support of an application for accelerated approval and have already filed the module 3 manufacturing information and the draft's proposed label. You can read about accelerated approval on the FDA website. It represents an approval pathway for fast track and breakthrough drugs whereby intermediate clinical data are presented in support of an initial approval with a concomitant commitment by the sponsor to present dispositive clinical proof of efficacy within five years. Last week, FDA granted a major expansion of the Fast track designation originally granted to NRX100 in 2017. Whereas the initial designation was related to bipolar depression, FDA has now broadened our fast track designation to encompass all patients with suicidal ideation in depression, including bipolar depression. The CDC estimates that 13 million Americans consider suicide each year and that an American dies from suicide every 11 minutes. Hence, FDA's broad and fast track designation offers NRX a tenfold greater opportunity to make a real difference in one of the largest public health crises to face our nation. Fda, under its new leadership and the maHA program, has dramatically focused on national public health crises by creating 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, provides enhanced communication throughout the review process, increase potential for accelerated approval of NRX100 to receive a CNVP, a product must meet at least one of the following must address a US public health crisis. It must deliver more innovative cures for the American people. It must address a large unmet medical need and this was noted in our Fast Track designation that we do in fact address a large unmet medical need. It must onshore drug development and manufacturing to advance the health interests of Americans, strengthen the US supply chain, or increase affordability. Our team believes that NRX100 meets all of CNVP's criteria on the second approval path. We filed the NDA in June of this year utilizing existing manufacturing data found in Module 3 of our Suicidal Depression NDA. We've since received comments from the FDA identifying only one scientific discrepancy along with some easily remediated administrative deficiencies. Specifically, FDA asked us to justify the level of a single inert ingredient in the formulation. We're actively addressing this matter with FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year, and we believe NRX100, made in the United States and offered without any toxic preservatives, offers patients and clinicians a superior option. Approval of the Citizens Petition Removing benzathonium chloride from the US Ketamine supply would give NRX a substantial position in that existing $750 million generic ketamine market. We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public. NRX101, our oral product for the treatment of suicidal bipolar depression, recently achieved an important milestone that is the filing of the initial module known as Module 3, the Chemistry Manufacturing Control Section or CMC, with the US FDA last week. This was filed under the previously granted Breakthrough Therapy Designation awarded to NRX101 and therefore we anticipate rolling review of this application. We're working diligently to complete this filing and will request priority review which if granted, would confer a six month review period. There are more than 7 million patients suffering from bipolar depression in the US and many of these are at risk of akathisia, a terrible side effect related to serotonin active drugs that is closely related to suicide and can cause an irresistible need to move, inability to sit still and all too often is associated with patients jumping off of roofs, jumping in front of trains and otherwise harming themselves in horrible ways. These patients are at tremendous risk of self harm and there are no current treatment options available that have been shown to reduce akathisia, although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors. NRX101, in our estimate, offers the only current treatment option that both reduces depression, suicidality and akathisia in this patient group and as an oral treatment should generate widespread accessibility and benefit in these patients. We look forward to coming interactions with the FDA on this application Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network. We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago, but needed to wait for state regulatory approval to acquire Dura Medical Inc.. That approval is now in hand as we announced last week. With that milestone reached, we anticipate that you will shortly see closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive, high quality care possible in each of our clinics continues to drive us and we look forward to continuing to update you on the progress of our network. The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network. We've identified additional milestones reached in our 10Q filing, including the FDA's grant of a PDUFA fee waiver, saving the company $4.3 million in filing fees. Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health. With the key milestones reached in Q2 and with the addition of a committed investor group based composed of experienced biotechnology investors, we now have the balance sheet capacity to continue our quest to bring hope to life well into the coming year. I will now turn it over to Mr. Michael Abrams, our CFO, to review our financial results from the second quarter of 2025. Mike.

Michael Abrams - Chief Financial Officer - (00:16:30)

Thank you Jonathan. For the first for the three months ended June 30, 2025, the company reported a net loss of $17.5 million versus a net loss of 7.9 million dollars 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 recorded in other expense, all of which is non cash. For the three months ended June 30, 2025, the company reported a loss from operations, which excludes the non cash 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 healthcare and biotechnology investors led by B Group Capital Partners. 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 one 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 Jonathan. Jonathan.

Jonathan Javitt - Founder, Chairman, and CEO - (00:18:36)

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 three potential drug approvals in the near term in 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. I would like to thank the NRX team, our longtime 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 - (00:19:25)

Thank you and ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press followed by the number one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys and to withdraw your question you can press Star two. With that, our first question comes from the line of Tom Schrader with btig. Please go ahead.

Tom Schrader - (00:19:48)

Good morning 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? Seems like you have very conventional clinical endpoints that you can argue you've hit and I think of accelerated approval for more biomarker type trials and And a quick one 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? Thank you.

Jonathan Javitt - Founder, Chairman, and CEO - (00:20:23)

Well, let me start with the second question first. I think the agency has been clear that the CNVPs are not to be sold. And certainly we would have no interest in selling a commissioner's national priority voucher were 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 NRX101, 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 NRX101 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 in 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 five years in which to demonstrate that NRX101 has a conventional long term benefit compared to placebo.

Tom Schrader - (00:22:54)

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

Jonathan Javitt - Founder, Chairman, and CEO - (00:23:04)

Yeah, the confirmatory trial. If you look at the approval path of Eli Lilly, 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.

Tom Schrader - (00:23:37)

Thanks for all the detail.

OPERATOR - (00:23:42)

All right, thank you. And your next question comes from the line of Jason Colbert with Deborrel Capital.

Jason Colbert - (00:23:50)

Good morning again. Yeah, 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 and D, you know, is that likely to ramp up in the future? Should we see it at about the same level? And gna, as you become a commercial entity, how do you envision GNA expanding? And I also have some questions about the acquisition pipeline associated with the clinics. Thanks.

Jonathan Javitt - Founder, Chairman, and CEO - (00:24:29)

So why don't we go to clinic?

Johnny - (00:24:33)

Oh Johnny, you want to answer the. Questions first, please go ahead.

Michael Abrams - Chief Financial Officer - (00:24:35)

Yep, okay. Sorry. So I'll add from a financial perspective. Jason, thank you for your question. I was. 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 10Q. 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 and A expense and R and D expense. And so the decline from 7 million dollars to 3 million dollars and change is as a direct result of internal budgeting and cost saving measures that we continue to execute on. 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 can be quite counterintuitive in its impact on the income statement, the balance sheet whereby you know, an increase in our stock price makes it look like an increased liability, increased expense. But those are all non cash. So really looking at loss from operations I think is the cleaner view into our financial picture. And you know, the trends of reducing our overall operating costs comprised of G&A and R and D are evident and we believe to be continued. Again, not prepared to give guidance on where that may go in the future. But you know, we announced it and discussed it because we think it's a worthy note of our financial statements that investors can take note of. With that I'll turn it back over to John.

Jason Colbert - (00:26:28)

I can appreciate your comments but you know, the expectation is that we would see GNA ramping up as you become a commercial entity. But. Well, I think what you're saying is temper, you know, expense ramp up with the strength of the balance sheet so that kind of comes together in sync. That's how I interpret what you're saying. Well, yeah, just to follow up on. That.

Michael Abrams - Chief Financial Officer - (00:26:55)

Any increase in GNA that is sometimes seen in these situations as commercialization comes also comes in line with, with revenue. And so we have been managing the business for what it is now as Jonathan mentioned in his comments during, during the call, we believe we're relatively near term commercialization and advanced, you know, all of all of our drug programs, as well as have opportunities with Hope Therapeutics. So as revenue comes on, we manage, will continue to assess those and make decisions. But you know, the timing, 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, you know, the revenue itself. So. But your point is noted.

Jonathan Javitt - Founder, Chairman, and CEO - (00:27:51)

Yeah, fair enough. Thank you. Typically, Jason, a question you know, 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.

Jason Colbert - (00:28:50)

Of course, Very reasonable. And Jonathan, how about the acquisition pipeline. In terms of clinics? And can you give any kind of idea of what you might look like? I mean, from a big picture point of view, five years from now, what do you think your footprint looks like?

Jonathan Javitt - Founder, Chairman, and CEO - (00:29:11)

Well, you know, five 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 Pharmaceuticals. And the companies that we would hope people would look at are companies like davita and Fresenius Medical Care 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 neuroplasticity 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 neuroplasticityity. If you want to make a computer chip, you take a piece of silicon, 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 neuroplasticityity 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 neuroplasticityity. 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 achieve neuroplasticityity 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 neuroplasticity therapies coming down the pike. 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 one. 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 five years from now. But I think five 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.

Jason Colbert - (00:33:59)

That's amazing. Thank you. I share your vision.

OPERATOR - (00:34:06)

All right, thank you. And your next question comes from the line of Patrick Troupio with HFC Wainwright. Please go ahead.

Patrick Troupio - (00:34:13)

Thanks. Good morning and congrats on all the progress. Advancing NRX100, NRX 101 and the Hope platform. It's clear the team's 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 benzathonium 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 NRX100? How challenging might it be for existing suppliers to adjust?

Jonathan Javitt - Founder, Chairman, and CEO - (00:34:55)

Well, the FDA's requirement is to respond to a citizen's petition within six months of filing. And we hope that FDA will beat that requirements. 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 benzophonium 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 Benzethonium Chloride (BZT) may not be entirely consistent from product to product. And if you read the toxicology paper that we posted last week for the public to read, as you have repeated doses of ketamine, you start to get a cumulative impact of this, what's called a quaternary amine preservative. In fact, one thing you'll see if you poke around is that there's a known incidence of ulcerative cystitis that is an inflammatory and serious condition of the lining of the urinary bladder associated with repeated use of ketamine. That's never been seen with repeated use of the JJ Spravato product, which is a nasal form of esketamine. Well, if you ask, what's different between the two products? Certainly intravenous ketamine is racemic, whereas the JJ product is the snantiomer. And clearly in one case it's given by nasal administration versus IV administration. But either way, once it's in the bloodstream, the residual product winds up being metabolized by the liver excreted in the bladder. And the main difference, or a main difference, is that there's no benzathonium chloride in the Johnson & Johnson product. So it may be that we're already seeing an impact of repeated use of a BZT containing ketamine in real life without having to look too hard for other examples. Now, in terms of what would be the impact of removing this toxic preservative from generic ketamine, it would, first of all, we think, benefit patients substantially because the only reason it's in the bottle is so that a doctor can stick a needle into the same bottle more than once and administer drugs from that bottle either to the same patients or to multiple patients. So there's no real benefit to the patient associated with injecting Benzethonium Chloride (BZT) into the patient. What would be the impact? The impact could well be that rather than a normal share of the generic market that we would associate with an ANDA for a US manufactured, safe and reliable form of ketamine, we might have a substantially larger share of that generic market while other suppliers readjust their formulations to take the toxic preservative out of those formulations. And since some of those current genetic suppliers have pretty much left this product on the shelf, it's not even clear how many of them would readjust their formulations and re enter the marketplace versus simply go on to other things. So grant of the citizens petition could really help us exceed people's financial expectations for us.

Patrick Troupio - (00:39:54)

That's really helpful. And just another Follow up on NRX100, 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?

Jonathan Javitt - Founder, Chairman, and CEO - (00:40:16)

Well, we think real world data in that quantity of patients certainly should motivate FDA to see the cases as substantially strengthened. The FDA guidance is that the agency really needs to pay attention to real world data. And Commissioner Dr. 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. That's a unique circumstance.

Patrick Troupio - (00:41:26)

Yes, that's interesting. And then just on NRX 101, you know, 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.

Jonathan Javitt - Founder, Chairman, and CEO - (00:41:55)

Thank you. You're asking a fascinating question. And, you know, we've identified a very provocative, in a good way provocative, scientific study that was performed out of Canada where investigators showed that NRX101. Well, they specifically showed that D-Cycloserine, the main active ingredient in NRX101, compared to placebo, enhanced the effect of transcranial magnetic stimulation, or tms, in treating depression. They didn't really give an antidepressant dose of D Cycloserin. 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 Cycloserin before the drug become a potent NMDA antagonist. So they used a much lower dose of D cycloserin. 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 NRX101. 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 major depressive disorder and ptsd. Right. That's really helpful.

Patrick Troupio - (00:45:10)

Thank you so much.

OPERATOR - (00:45:14)

All right, thank you. And your next question comes from the line of Ed Wu with ascendient Capital. Please go ahead.

Ed Wu - (00:45:22)

Yeah, congratulations on all the progress. What is your commercial strategy with NRX 100 and 101? Are you going to wait until closer. To approval to, you know, actually, you. Know, expand, potentially get a salesforce?

Jonathan Javitt - Founder, Chairman, and CEO - (00:45:38)

Yeah, it's a wonderful question. And you know, 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 dropped a drug approval in your lap?

Matthew Duffy - Chief Business Officer - (00:46:33)

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 Medimune is probably the most notable, but also at Lev Pharma, where it's a pretty focused launch for both of these drugs, it'd 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'll 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, an 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 Medical Science Liaisons (MSLs) was about 20 people, and that was a very focused group of folks in about 500 hospitals. And. And then at Lev, it was a similar situation with individual rheumatologists that we were targeting. So for NRX100, you probably launch 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 NRX100. 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 15 or 1600 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, field personnel. Those folks may be a little bit more expensive because you may have a little bigger tilt towards MSLs, but you can cover, you know, 1500 high prescribing bipolar psychiatrists, you know, with not that many reps. And so those are, those are pretty focused efforts. And then the marketing behind it therefore is more focused as well. So I think these are two 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, you know, the company will, you know, 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, you know, 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 Vero Pharma bought us shortly thereafter. And so it can be really focused and it can be a very efficient launch. And you know, the nice thing about that is you hit profitability much, much, much more quickly than if you have a 500 person primary care sales force like, you know, Pfizer would. We want to launch with at Pfizer.

Ed Wu - (00:50:00)

Great. Thanks for answering my questions and I. Wish you guys good luck. Thank you. Thanks, Ed.

OPERATOR - (00:50:07)

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

Matthew Duffy - Chief Business Officer - (00:50:15)

Well, thank you everyone for joining us this morning. We're extremely excited about the path ahead with three potential approvals and our HOPE subsidiary targeting multiple profitable mental health clinics and interventional psychiatry centers. This concludes the NRX Pharmaceuticals second quarter 2025 results conference call. Thank you all for participating.

OPERATOR - (00:50:34)

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