Good morning, everyone. My name is Blake Roberts. I'm a partner at Centri Business Consulting, where we specialize in IPO readiness and financial reporting. Here to introduce Matt Duffy from NRx Pharmaceuticals, which happens to be a client of ours, and give it away to Matt. Thank you.
Thanks very much. Good morning, everyone, and thanks for joining us today for this presentation for NRx and Hope Therapeutics. My name is Matt Duffy. I'm the CBO at NRx and the co-CEO at Hope Therapeutics. I'd also like to welcome everybody joining us on the webcast. Today we'll talk about a number of forward-looking statements. Everything is in our Safe Harbor statement. Things said today we know to be true today, but things can change. So let's set the stage. Suicidality is a national crisis in the United States. According to the CDC, in 2022, 49,000 people actually committed suicide, probably a lot more who were classified in a different way than just direct suicide. Interestingly, and what we're really focused on is preventing suicide.
Our company is dedicated to preventing suicide in a number of different ways, not just in acute situations, but more chronic, as well as in care delivery. And we'll talk about each of these today. But the number of people in this country, 13.2 million make serious thoughts about suicide every year. And in fact, 3.8 million, a stunning number, actually make an active plan to commit suicide. And we aim to help these people. It's worse with bipolar. If you know two people with bipolar depression, one of them will attempt suicide in their lifetime. And in fact, one in five of those will succeed. It's lethal as some cancers. So what are we doing about it? We have acute, more chronic, and then care delivery opportunities for patients with suicidality and to prevent suicidality. First, NRx-100, which is our IV ketamine. It's a remarkable drug.
We're planning on filing this year of an NDA for suicidal depression. We have four efficacy studies that are very convincing, along with a dose-ranging study. I'll share those data with you in a moment to support the NDA. In addition, we have manufacturing data, tox data, and we have aligned on our pediatric study plan, all of which are required to file an NDA, and ketamine is a huge opportunity. As you said, as we saw, there were 3.8 million people this year expected to make a plan to commit suicide. We can help them, and that's a big market. The second opportunity is NRx-101, which is an oral combination of D-cycloserine and lurasidone, and that's designed for suicidal bipolar depression.
And we've gone through two studies of that where we've actually demonstrated a high level of efficacy in terms of antidepressant efficacy, but vitally also reduced suicidality and akathisia compared to the standard of care, lurasidone, for bipolar depression. And we're focused on filing an NDA for accelerated approval also this year with the FDA for bipolar patients with akathisia or suicidality. It's a focused initial launch. There's a small number of physicians who do that, who treat those patients. We can execute that launch ourselves. We'll look for a partner for a bigger Phase 3 confirmatory trial for the broader bipolar opportunity, which is about seven million people. But this is also a massive market for us. Third, Hope Therapeutics is actually delivering care to patients who are potentially suicidal or depressed. It will be the first national network dedicated clinics to treat suicidally depressed patients.
We are rolling up some of the best-in-class clinics in the country. We're going to establish a nationwide standard of care across these clinics. Our approach with this is a very disciplined one. We're looking for clinics with revenue and positive EBITDA. So we can move forward with this immediately accretive to both revenue and EBITDA to both NRx and obviously to Hope. As you may have seen, we announced this morning the signing of our second LOI for a clinic acquisition. These were our first two clinics in the state of Florida. Our initial one we announced was in Southern California with a worldwide thought leader in the field. So we're really building an excellent base for growth into the vicinity of 30 or so clinics over the next year, year and a half. Together, we can address quite a number of patients here.
If you combine all these different markets along with chronic pain, which we're doing work on as well, we can have the potential to reach over 70 million people, so let's get into it a little bit more. NRx-100, IV ketamine. If we're successful with this NDA, we will be the first drug, or FDA-approved ketamine, to treat suicidal depression. Today, it's a huge unmet medical need because the only approved treatment for suicidality is electroconvulsive therapy, ECT. It hasn't changed that much since One Flew Over the Cuckoo's Nest. It's still the same thing with the same problems. They treat the patients a little differently with sedatives and that sort of thing, but that's it. That's the only approved product. IV ketamine is really catching on in the psychiatry community, but it's not approved and when it's not approved, it doesn't get reimbursed.
So unless you're a patient who can walk in with $500 or $1,000 for a cash payment for ketamine, you're not getting it. And we aim to change that with an approved label. So why isn't there an approved ketamine? It's been out there forever. And the reason is that nobody's asked. You have to have, obviously, patient-level efficacy data. You've got to have manufacturing and drug in hand. You have to have stability. And you have to have tox data. We have all of these. The FDA had asked us some time ago to file an NDA for ketamine. We had thought esketamine, Johnson & Johnson Spravato, was going to take up that spot in the market, and it just hasn't.
It's a billion-dollar drug, but it's really only scratched the surface for it because of some frustration with efficacy and some frustration from patients trying to take the intranasal formulation. So there's a huge opportunity and a huge need. We can address all of these, and we're in the process of doing that right now. So this is the summary of the efficacy that we'll be using to support our NDA. First, the FDA loves a dose-ranging trial. And there's a dose-ranging trial that was conducted up at Harvard, and they looked at a whole range of doses and have selected half a milligram per kilogram, so we know what dose to use. And then there are two studies, randomized placebo-controlled trials. One was conducted by the French government in seven centers across the country with 156 patients, showing a very high level of statistical significance.
Same thing happened in Columbia with another 80-patient trial. That one was interesting. I'll show you in a minute, but it has an active placebo. It addresses some of the issues you may have seen with the MDMA discussions in recent weeks, and then there's also a head-to-head trial against ECT, showing very strong efficacy, maybe better than ECT, but a much, much more favorable product profile, obviously, so these are all on our website, so if you want to get into this any more deeply, feel free. It's right on the landing page of our website. There's a link for it, but the first study is the Abbar study, 156 patients conducted in seven centers in France, and I won't dwell on it too much, but the key things you can see. Number one, the efficacy was outstanding. Our founder, Jonathan Javitt, calls this almost magic.
You can take somebody that's actively, acutely suicidal and within a couple of hours have them calm down and having normal conversations. It was especially effective in bipolar, which is something we're obviously very interested in. The Columbia study is interesting. It was 80 patients paid for by NIH at Columbia, but they used an active placebo. It's called midazolam, and you can see here that the midazolam, it kind of masks it because it's not like just a placebo where you don't feel anything. People expect to feel something with ketamine, so the midazolam is like a Valium type of drug, so you get a little sleepy, and it kind of masked it, but what they did, you can see, again, very, very rapid efficacy for IV ketamine. It was positive compared to placebo.
But then they took the placebo patients, and the green line is when they gave them IV ketamine a day or two later. And again, high level of efficacy, 0.0015. This was a comparison to electroconvulsive therapy. As you can see, very strong efficacy on treating the suicidality, but certainly much more favorable in terms of memory loss and suicidal ideation. And so what you can see is that you have very strong efficacy and support. And the psychiatry community is really getting behind this as well. These are a couple of JAMA Psychiatry editorials over the last year or so. And there's a clear preference for ketamine over ECT in this editorial. And also, they're talking about the need for properly labeled and properly controlled IV ketamine out in the community in clinics. And that's where we're going with Hope, as well as our IV ketamine.
As I mentioned, we have manufacturing data. We've aligned on the neurotox protocol. We have stability, and we have commercial-scale manufacturing in place. Also, remember, ketamine is still on drug shortage. There are access issues that we can help address. Additionally, our formulation will have no preservative. Benzalkonium chloride is used in multi-dose vials. It was designed originally with ketamine for a single dose for anesthesia, not more chronic and regular uses. It really does have some safety problems. We'll address that by removing that, and it'll make it a very favorable presentation for the clinics that use a fair amount of ketamine. Where does this leave us? With an approval of IV ketamine, we'll get our three years of exclusivity. No ANDAs for us for that period of time.
In that period of time, we'll get reimbursement and get that moving for patients right away. There will be a REMS program around the drug that will really severely restrict access outside of our drug. And we're subsequently developing a pH-neutral version of ketamine that will expand its potential use even to subcutaneous, which isn't available now. And finally, there's a digital therapeutic that we're developing. We're going to adapt from something Jonathan Javitt actually did in a prior life for DARPA and the military that was highly successful in reducing anxiety and stress. We can use this to prolong the efficacy of ketamine. Our second drug product, NRx-101, for bipolar depression with suicidality or akathisia. Non-addictive, non-psychedelic, that can be either it's oral. And it's the first and only antidepressant to reduce suicidality, particularly an oral one. It's a brilliant discovery.
Jonathan's brother, Daniel, has spent decades on the NMDA receptor, which ketamine hits the NMDA receptor, and NRx-101 does as well. In a slightly different fashion. But over the course of the last three decades, Dan Javitt up at Columbia University discovered the role of the NMDA receptor in the brain, the effect of accelerating the NMDA receptor in terms of developing psychosis, and thirdly, how to treat it and how to treat it safely. This has formed the basis of 91 patents that are filed or that are issued or pending. And we've really shown the most important thing to be the reduction not only of depression, but also akathisia. That's been critical, and we'll talk about it in a second. So we've got the medication for an NDA filing or the data for an NDA filing.
It's supported for an accelerated approval because there's absolutely nothing out there for akathisia to treat the akathisia or suicidality in the community with an oral drug. Even just that narrow indication for the accelerated approval is at least $2 billion for us. So it's really something important for both the company and for patients. We'll do an additional phase three trial, a confirmatory trial to address the broader bipolar population. And we intend to do that with a partner for the larger capital requirements. And it really addresses a critical issue. We have a black box warning on basically every antidepressant that's out there for increase in risk of suicide. And that's brutal because patients are prone to that in the first place, and it accelerates with these antidepressants. We've addressed that.
This trial was presented by Andy Nirenberg, who's the head of bipolar research at Harvard, a couple of months ago at the American Society of Clinical Psychopharmacology meeting. It's a Phase 2b/ 3 trial in 93 patients. Critically, as you can see, similar reduction to the standard of care, lurasidone, in reducing signs of depression on the MADRS scale but critically, a reduction in akathisia. Now, akathisia is a side effect really only seen with serotonin-active drugs and primarily antipsychotics like lurasidone and it's just this feeling that you've got to move. You have to move around. It's like you're just going to jump out of your skin. Those are the people who will jump buildings in front of vehicles, that sort of thing and so reducing that is critical, according to the KOLs that we know. They say it's the worst side effect of bipolar treatment.
And there's no treatment for it once you're on, other than to try and stop the antidepressant in a really badly bipolar patient who's in a bad spot, which is really not acceptable. And so this is the first trial to enroll suicidal patients also. So it was a really vital study to publish. And it was supported by a trial we did a couple of years ago in actively suicidal bipolar depression patients. We gave them a dose of ketamine and then either our drug, NRX-101, or lurasidone. And it was actually superior in maintaining the depression reduction and the suicidality reduction that ketamine provided with a single dose. Additionally, there was a reduction in relapse rate, as well as a statistically significant reduction in the suicidality scale, the Columbia suicidality scale. And also a trend on the akathisia again. So what does this profile look like?
It looks like a product that's as good or possibly even better than the standard of care in terms of treating the depression in bipolar depression, dramatically reduces the most troublesome and dangerous side effect of this treatment. And that looks like to us and to the KOLs we've talked to, this could be the drug of choice for bipolar depression in these patients. And so we're going to put an accelerated approval and do everything we can to get this to patients as soon as possible. As I mentioned, we have a very strong patent portfolio. It's 91 issued and pending patents. It centers around composition of matter patent, which I hadn't seen before.
But it's two older drugs, but the importance of reducing these side effects of akathisia and hallucinations that you can see sometimes with DCS was so critical that they gave us a composition of matter patent. That should take us covered into the mid-2030s and provides an excellent foundation there. We have manufacturing in place. We moved it onshore during COVID. And so it's U.S.-based manufacturing. We had a Type C meeting with the FDA in 2022 on concurrence on CMC and stability. And we have about a million doses in a warehouse already. So the manufacturing is in good shape with NRX-101. And finally, Hope Therapeutics. We started as a treatment for suicidal bipolar depression. We've really expanded to not only the research and development for treatment of these patients, but also the care delivery now.
Hope Therapeutics will be the first nationwide network dedicated to treating suicidally depressed patients in the community clinic setting, as well as patients with PTSD. It's a novel idea to focus on this going forward. What we want to do is really provide the state-of-the-art interventional psychiatry to patients who are in need anywhere they are in the country. That can be ketamine, but not necessarily. There's a lot of other options out there, such as TMS and talk therapy and medication management that all have to work together.
Our vision is that when people tell their story of their journey in mental health in the country, they can say, "I finally found a Hope clinic, and they've cured me." And I think a word of caution also on ketamine, as everybody's seen in the news, this is not a drug that can just be used recreationally or taken and given to people and told them to take it home and take it. It needs to be done in a proper setting with properly trained healthcare providers with the correct patients. And it should be psychiatrist-led, we believe. We should have common protocols across all the clinics. So the state-of-the-art is available to everybody. And we should keep an eye on the outcomes because we want to be sure that we're actually doing what we think we're doing with these patients.
The answer is it's not just ketamine either. TMS, transcranial magnetic stimulation, is an FDA-approved, insurance-reimbursed treatment that has been shown to be very effective, not only in and of itself, but also to prolong the effect of ketamine. Digital therapeutics, as I mentioned, Jonathan Javitt, our founder and CEO, has also developed a digital therapeutic in the past that we're going to work to adapt to specifically extend the effect of ketamine. What they did, and you can see some of the data here, they went into a military situation and administered this digital therapeutic. It was designed as sort of a video game, so war fighters would get it, it wouldn't seem like a chore to do it.
In using it and then taking these same folks and putting them into simulated combat situations, they actually saw significantly reduced anxiety and better effect of the war fighters in these simulations. We want to adapt that. It'll also be a huge differentiating point for our clinics because this will be a proprietary approach to these patients. It's part of NRx, but we are working towards a spin-out on this. Why do that? The main reason is it's a completely different business from a drug discovery and development company. It's different risk profile, different investor profile. The way it's going to operate is going to be completely different from an R&D-driven pre-revenue biotech. We'll focus on this broad range, not just our drug here, to be sure that we're giving the best treatment to patients.
But we're also working towards making sure that there's access through wide insurance reimbursement for all of our therapies. We can still continue to offer ketamine through the 503(b) pharmacy. And we will finance this completely separately from NRx, so it doesn't affect the NRx balance sheet. So in sum, what do we do? We want to acquire probably over the next year, year and a half, about 30-plus clinics, get to a little over a $100 million run rate by the end of next year. We're starting with a couple of really outstanding clinics and clinicians that will also come on board and help us lead this effort as well. One of the people you'll see we press released recently, you'll see more detail on him, is one of the originators of the use of ketamine in interventional psychiatry in the country in Southern California.
And our idea in what we're doing is rolling up companies with both revenue and EBITDA. So we're not starting things from scratch. We're not going into new areas where nobody's ever been. We're actually buying EBITDA. And so we can finance that with corporate bonds and normal corporate debt rather than going into the biotech equity market. And the idea is to take good clinics and just make them great. So what you want to do is get maybe a set of clinics that are offering some services, but maybe not all. Maybe they need more hours. Maybe they need to alter their product mix, and maybe they're not utilizing more advanced therapies to the extent we think, and our psychiatry leadership team thinks they should be utilized and grow EBITDA. And there's an established market out there of buying and selling these clinics.
What you can see is it's just a multiple of EBITDA. If you grow EBITDA, you grow value. How does this benefit NRx specifically in our stock? First of all, it's a source of revenue that will be consolidated initially. We'll have a good revenue run rate by the end of next year. It's a big asset for NRx's balance sheet to address shareholder equity and potentially even throwing off cash to the company over the next several months. We have a very strong leadership team. Jonathan Javitt, I've mentioned, has a long career both as a clinician, as a drug developer, as an advisor to four consecutive presidents on healthcare-related issues. He's been our founder and leader since the beginning. Rick Panicucci is an outstanding CTO. He's led a load of NDA-approved manufacturing efforts.
My background's financial, everything from Pfizer and MedImmune through Lev, as well as financial, numerous investment banking, and venture capital roles as well. Our CFO is Richard Narido, who's terrific. We're taking this forward. We've got great advisors. As I mentioned, Dan Javitt, brilliant. Marion Leboyer is one of the best-known psychiatrists in France. Andy Nirenberg's the head of bipolar research at Harvard. Gerard Sanacora is the head of depression and ketamine at Yale. Phil Lavin, a lot of you probably know, is an excellent statistician and very well-known to the FDA. So come and join us. This is a heck of a journey for everybody, patients and the company alike. We're very anxious to move ahead. I'm glad to take your questions. It's a great question. Thanks very much. My background has been a lot of business and operations.
This is going to be a very important operation to both select clinics, to finance them, and to operate them. I've operated a number of businesses, including I was in the medical cannabis world for a while and ran a multi-state operator that also had a number of individual outlets, local outlets. We had to manage those. There's some nice overlap there, but also coming at it from a patient-focused point of view, which when you come out of biotech and pharma, you really are thinking more about the patients than the company as much, or at least I did.
And to be able to apply the idea of getting patients in the Hope clinics the best possible treatment and not just one treatment that I'm advocating for, as you would with my time at Pfizer or MedImmune or whatever, but really being able to say, "Okay, let's step back. What really is the best for the patient?" And really supporting our psychiatry team in implementing those across the country and figuring out a way to make sure the business works because it's a good business, but it's got to be run and managed. So thanks.
Any other questions? Obviously, feel free to meet Matt afterward down on the floor for any other questions that you want to ask him. But otherwise, it's going to be a round of applause. Thank you very much.