NRx Pharmaceuticals Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 20, 2025

Key Takeaways

  • Positive Sentiment: The company halved its operating loss year-over-year to $3.7 million (excluding non-cash fair-value charges), demonstrating improved cost efficiency.
  • Positive Sentiment: NRx100 advanced on two regulatory fronts with an NDA for suicidal depression and an ANDA for preservative-free ketamine, earning an expanded Fast Track designation and potential for a National Priority Voucher.
  • Positive Sentiment: A citizens petition was filed to remove benzethonium chloride from all U.S. ketamine, positioning NRx to capture a significant share of the ~$750 million generic ketamine market.
  • Positive Sentiment: NRx101 filed its CMC (Module 3) under a Breakthrough Therapy designation, seeking priority review for an oral treatment targeting bipolar depression with suicidality and akathisia.
  • Positive Sentiment: Hope Therapeutics secured state approval to acquire Dura Medical and is finalizing acquisition financing, building a network of interventional psychiatry clinics to drive future revenue.
AI Generated. May Contain Errors.
Earnings Conference Call
NRx Pharmaceuticals Q2 2025
00:00 / 00:00

There are 6 speakers on the call.

Operator

Good morning, ladies and gentlemen. Welcome to NRx Pharmaceuticals Q2 twenty twenty five 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 0 for the operator.

Operator

This call is being recorded on Wednesday, 08/20/2025. I would now like to turn the conference over to Matthew Duffy, chief business officer. Please go ahead, sir.

Speaker 1

Thank you, Ludi, 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 security laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Speaker 1

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 Investor page of the NRX Pharmaceuticals Inc. Website. Joining me today on the call are Jonathan Javitt, our Founder, Chairman and CEO and Mike Labrums, our Chief Financial Officer.

Speaker 1

Doctor. 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.

Speaker 2

I'll now

Speaker 1

turn over to Paul to Jonathan. Jonathan?

Speaker 3

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.

Speaker 3

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 multiunit 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 forgoing 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've 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.

Speaker 3

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 ten years, I cared for patients with chronic glaucoma first at Johns Hopkins and then at Georgetown Universities.

Speaker 3

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 and to the nerves of the cornea. That's why so many eye drops have gone preservative free over the years.

Speaker 3

Well, the first cousins of 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 seventy 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 BCT and ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia.

Speaker 3

The problem is patients who get ketamine for depression often get repeated administrations. As we've shown the FDA in our citizens 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 citizens 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 as safe, that's called the GRAS list by the FDA. Indeed, FDA's concern about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics.

Speaker 3

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 NRx100 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 ECT or electroconvulsive therapy.

Speaker 3

Our corporate presentations highlight randomized controlled trials demonstrating superiority of ketamine to placebo, to active comparator, along with demonstration of equivalence to ECT overall in more than one thousand patients. We'll be presenting real world data for FDA's consideration on nearly one hundred and eighty thousand 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 three manufacturing information and the draft 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 this positive clinical proof of efficacy within five years.

Speaker 3

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 thirteen million Americans consider suicide each year and that an American dies from suicide every eleven minutes. Hence, FDA's broadened 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 one to two months versus the standard ten to twelve month review, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRx100.

Speaker 3

To receive a CNPV, a product must meet at least one of the following criteria: 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.

Speaker 3

Our team believes that NRx100 meets all of CMTV's criteria. On the second approval path, we filed the ANDA in June, utilizing existing manufacturing data found in module three 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.

Speaker 3

The existing market for ketamine has been projected at approximately $750,000,000 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 benzathodium chloride from The US ketamine supply would give NRx a substantial position in that existing $750,000,000 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 milestone that is the filing of the initial module known as Module three, the Chemistry, Manufacturing and Control Section or CMC with the US FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to NRx 101, and therefore, we anticipate rolling review of this application.

Speaker 3

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 seven 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.

Speaker 3

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 a state regulatory approval to acquire Dura Medical. 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.

Speaker 3

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 10 Q filing, including the FDA's grant of a PDUFA fee waiver saving the company $4,300,000 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.

Speaker 3

I will now turn it over to Mr. Michael Abrams, our CFO to review our financial results from the second quarter of twenty twenty five. Mike?

Speaker 4

Thank you, Jonathan. For the first for the three months ended 06/30/2025, the company reported a net loss of $17,500,000 versus a net loss of $7,900,000 for the comparable quarter in 2024. The increase in the net loss was driven by approximately $12,000,000 charge in fair value accounting measurements related to previously issued convertible notes and warrants recorded in other expense, all of which is non cash. For the three months ended 06/30/2025, the company reported a loss from operations, which excludes the non cash impact of fair value accounting measurements of 3,700,000.0 versus a loss from operations of 7,100,000.0 for the comparable quarter in 2024. This marks an improvement of more than 3,300,000 or 47% compared to the prior comparable quarter.

Speaker 4

As of 06/30/2025, NRx had approximately $2,900,000 in cash and cash equivalents. On 08/18/2025, the company closed a registered direct offering with a select group of experienced long term healthcare and biotechnology investors led by B Group Capital. In connection with that offering, the company issued approximately 3,900,000.0 shares of common stock and received net proceeds of approximately 6,500,000.0. 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 banking connection with the offer.

Speaker 4

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?

Speaker 3

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 and 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.

Speaker 3

Operator, we're ready to take questions from the audience.

Operator

Thank you. And to withdraw your question, you can press 2. With that, our first question comes from the line of Tom Schrader with BTIG. Please go ahead.

Speaker 4

Good morning, and it really has been a lot of progress this quarter. I have a couple of quick ones. For 01/2001, why is the pathway accelerated approval? Seems like you have very conventional clinical endpoints that you can argue you've hit. And I think have accelerated approval for more biomarker type trials.

Speaker 4

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? That been defined yet? Thank you.

Speaker 3

Well, let me start with the second question first. I think the agency has been clear that the CNPVs 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 lifesaving 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.

Speaker 3

As far as accelerated approval for NRx-one hundred one, 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-one hundred one 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.

Speaker 3

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 NRx-one hundred one has a conventional long term benefit compared to placebo.

Speaker 4

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

Speaker 3

Yes, the confirmatory trial, if you look at the approval path of ELETI, for instance, the confirmatory trial would be a very conventional randomized controlled trial of NRX101 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. All right,

Speaker 4

thanks for all the detail.

Operator

Right. Thank you. And your next question comes from the line of Jason Kolbert with D. Borel Capital. Please go ahead.

Speaker 5

Morning. Again, yes, 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, that likely to ramp up in the future? Should we see it at about the same level?

Speaker 5

And G and A, as you become a commercial entity, how

Speaker 3

do you

Speaker 5

envision G and A expanding? And I also have some questions about the acquisition pipeline associated with the clinics. Thanks.

Speaker 3

Why don't we go to clinic?

Speaker 4

Oh, Johnny, you want to

Speaker 3

answer this Please go ahead. Okay, sorry.

Speaker 4

So I'll answer 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.

Speaker 4

And so as a pre revenue company, that entirely made up of G and A expense and R and D expense. And so the decline from 7,000,000 to 3,000,000 and 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 actual the net loss that was reported, because that involves fair value accounting, which some people call derivative liability accounting, which can be quite counterintuitive and 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 DNA and R and D are evident and we believe to be continued.

Speaker 4

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 take note of. With that, I'll turn it back over to John.

Speaker 5

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

Speaker 4

Well, yeah, just to follow-up on that. Any increase in G and A that is sometimes seen in these situations as commercialization comes also comes in line with revenue. And so 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 advanced all of our drug programs, as well as have opportunities with Hope Therapeutics. So as revenue comes on, management will continue to assess those and make decisions.

Speaker 4

But 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.

Speaker 3

Yeah, fair enough. Well, Thank you. Typically Jason, question, you know, like that, you know, is gonna 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 and 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.

Speaker 3

So that the projected increased costs of G and A will be closely tied to an increased probability of corporate success.

Speaker 5

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?

Speaker 3

Well, 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, 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. You know, 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.

Speaker 3

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 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.

Speaker 3

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 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.

Speaker 3

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 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.

Speaker 3

So we may be able to identify $100,000,000 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 $100,000,000 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.

Speaker 5

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

Operator

All right. Thank you. And your next question comes from the line of Patrick Trucchio with H. C. Wainwright.

Operator

Please go ahead.

Speaker 2

Thanks. Good morning, and congrats on all the progress advancing NRx100, NRx101 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.

Speaker 2

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?

Speaker 3

Well, FDA's requirement is to respond to a citizen's petition within six 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.

Speaker 3

So they know a lot about benzathodium chloride, maybe even more than we do. In terms of impact, right now the generic ketamine market is $750,000,000 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 and measured ourselves, that level of 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 cautery 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 J and J Spravato product, which is a nasal form of esketamine.

Speaker 3

Well, if you ask what's different between the two products, certainly intravenous ketamine is racemic, whereas the J and J product is the S enantiomer, 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 benzathodium chloride in the J and J 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.

Speaker 3

But 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 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 reenter the marketplace versus simply go on to other things.

Speaker 3

So granted the citizens petition could really help us exceed people's financial expectations for us.

Speaker 2

That's really helpful. And just another follow-up on NRx100. I think you mentioned plans to submit real world data from nearly one hundred and eighty thousand 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?

Speaker 3

Well, 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 Makari has said very clearly that he wants to move the agency solidly into the twenty first 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. 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.

Speaker 3

That's Yes, a unique

Speaker 2

that's interesting. And then just on NRx-one 101, it's an interesting highlight of the potential synergy between NRx-one hundred one 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?

Speaker 3

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-one hundred one, 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. And they didn't really give an antidepressant dose of D cycloserine, they gave about one hundred 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 Javit has done most of the work as supported by patents all over the world in demonstrating that you have to get to about four hundred to five hundred milligrams a day of D cycloserine before the drug becomes a potent NMDA antagonist.

Speaker 3

So they used a much lower dose of D cycloserine, they used one hundred 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 US academic medical centers about mounting a confirmatory clinical trial in that area. It would be a very interesting label expansion for NRx-one hundred one, 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.

Speaker 3

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.

Speaker 2

Right. That's really helpful. Thank you so much.

Operator

Alright. Thank you. And your next question comes from the line of Ed Woo with Ascendiant Capital. Please go ahead.

Speaker 2

Yes. Congratulations on all the progress. What is your commercial strategy with NRx100 and 101? Are you going to wait until closer to approval to actually expand potentially get a sales force?

Speaker 3

Yeah. It's a wonderful question. 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 on Wall Street as a highly respected research analyst.

Speaker 3

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?

Speaker 1

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, Metamune is probably the most notable, but also at Love Pharma, where it's pretty focused launch for both of these drugs. It'd be different with different targets. If you think of NRx100, 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 they'll administer these medications at this point that'll grow once you have a reimbursed product.

Speaker 1

But, when you start looking at those numbers and thinking about what a rep or an MSL or a business folk person, an administrative person might be able to do. You probably can get away and really be successful with small commercial force. I think at MedImmune our initial group of reps and MSLs was about 20 people and that a very focused group of focusing on about 500 hospitals. And then at Leve it was similar situation with individual rheumatologists that we were targeting. And so for NRx100, you probably launch with around 20 people and you can do the math on what MSLs and reps cost these days.

Speaker 1

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 NRx101 but look different. There is a very focused number of perhaps, I think the number is about 1,500 or 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.

Speaker 1

Those folks may be a little bit more expensive because you may have a little bit bigger tilt towards MSLs. But you can cover 1,500 high prescribing bipolar psychiatrists with not that many reps. And so, 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 suicidality for both will have a lot of overlap.

Speaker 1

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 twenty, 25 person commercial organizations with the supporting infrastructure. It's really focused. Did it with not a lot of money at MedImmune, and they did it with not a lot of money at Levin and when Veropharma bought us shortly thereafter. And so it can be really focused and it can be a very efficient launch.

Speaker 1

The nice thing about that is you get profitability much, much, much more quickly than if you have a 500 person primary care sales force like Pfizer would we would launch with Pfizer.

Speaker 2

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

Speaker 3

Thanks, Ed.

Operator

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

Speaker 1

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

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