Please feel welcome to submit questions using the Zoom Q&A interface at the bottom of your screen. After the presentation, we'll open to your questions, and with that, Raphi, I'll turn it over to you.
Excellent. Thank you, Alex, and thank you all for joining. Good morning to everybody. It is fantastic to be here again. This has been a very, very busy two weeks for Alpha Tau. A lot of stuff going on, so I'm really excited to be in front of you and talk about what we're doing now. I'm going to start with a short introduction just to remind those of you who either haven't heard our story before or need a quick refresher. I'll talk about what we're doing, where we are, and again, some of the recent updates over the past few weeks that have been very exciting and really reflected a lot of the momentum going on at the company, so just as a quick refresh, we are the only ones who are using alpha particles locally, directly in tumors.
When I say locally, I mean I see a tumor over there on the image, and I want to cut it out or radiate it by getting directly into the tumor. Today, more than half of cancer patients are getting local radiation. They're all doing it using the traditional forms, the gamma and beta radiation that have been used for many, many years. And we'll talk about why that is and what are the limitations there. We are enabling a direct injection into the tumor of a radioactive source using a much more potent and much more efficient dose of radiation that really is designed to stay where we put it and not bleed into the surrounding healthy tissue.
When I talk about using a much lower dose, it's both because the radiation itself is much more efficient, alpha particles are much more efficient in the way they kill tumor cells, and also because as the dose is not being diluted to the areas around it, it means that we can really focus the dose where we want it. And so we are dosing tens, hundreds, even thousands of times less than the radiation normally given to cancer patients today. It is so much less that we can ship it in DHL or FedEx if we want to, in a cardboard box. It is so much less that we can do it in a regular procedure room without needing the nuclear bunker with the lead in the walls and the lead in the floors and the lead vest.
Again, it's a much lighter touch procedure because of how focused and efficient this radiation is, and so we are exploring it across a number of tumors, have had some great progress there in recent weeks, as I'll discuss, but we think the treatment, because it is injected directly into the tumor, can really be relevant to any solid tumor as long as we can figure out how to get there and inject this in an appropriate way into the tumor, and so we are testing it across a bunch of tumors. In preclinical work, we've seen that every tumor type we've tried it on, over 20 tumor types, they all respond, and so now we are really just in the process of going through different human tumor types and testing it there as well, so there's a lot of stuff going on here.
I'm going to start with this and then come back to that at the end. Again, a lot of milestones coming on just because of how active we are, and so you think about our lead indication, the pivotal study in recurring skin cancer in the U.S., where we said we expect to finish recruiting patients next quarter and then get data later in the year for submission to the FDA. In the pancreas, we have a very exciting trial in the U.S. we'll talk about as well. Also looking to complete the recruitment in that pilot study by the end of Q1 and then as well, hopefully get some data later in the year. This is actually one we've just completed yesterday. We announced our first patient treated in recurrent glioblastoma treated at Ohio State University.
This is a fantastic milestone for the company, a tremendous amount of excitement internally and with the clinicians that we're working with. Our first time treating brain cancer, obviously a devastating cancer, glioblastoma, very successfully so far in terms of the ability to administer the treatment, so we announced yesterday the first patient came in. We got very good coverage of the tumor, over 95% coverage of the tumor at our very first shot. Doctors are very excited. The team is ecstatic. We are very excited to be underway now treating patients in the brain and hopeful that maybe we can bring a new source of alternatives here for these patients with very devastating cancers, and then finally as well, in Japan, we've submitted for approval in recurrent head and neck cancer, and we are, we believe, just weeks away from getting an answer there.
So also looking to get that milestone very soon. So just to talk quickly about what it is that we're doing for those of you who haven't seen it before, whereas other forms of local radiation rely on beta radiation or gamma radiation, like X-rays that one shoot externally at the body. X-rays, of course, can penetrate the body. That's why we use them for imaging. The issue is, of course, that while you can get to where you need to go, it will also keep going. We will see them continue to proceed throughout the body in areas you may not want them to get to. And so you can cover the tumor, but given both the inefficiency of the radiation, which requires a relatively large dose, as well as the long range, we see a lot of damage in the surrounding healthy tissue.
Alpha particles, which are emissions from a radioisotope that are heavy and large, they have size and mass to them and a lot of energy. So these are much more efficient ways to kill cells. However, they have a very, very short range in tumor. This has always been the issue for them. When you place an alpha-emitting radioisotope into a tumor, you find that you get 40-90 microns of range, which is enough to kill three or four cells, but is really useless from a clinical perspective. And so no one has been able to use alpha particles locally because you just can't get them to move far enough into a tissue. Not only do they get stopped by a sheet of paper, they even get stopped by a few inches of air.
And so again, the ability to get these alpha particles into the tissue, or rather the inability to do so, is the reason no one has done local radiation today using alpha particles. So the way in which we overcome this is basically by injecting a tiny radioactive source, a piece of metal, which is coated with Radium-224. The radium is useful because it breaks down six times naturally before it stabilizes. It releases a bunch of alpha particles out on the way, and these alpha particles will smack into something and they'll kill it and they'll stop very quickly.
But what's really unique here is that we've trapped the radium right near the surface of the source in a way where it can escape, but its daughter atoms, as we call them, these steps in the decay chain, so they will actually recoil off of the source into the tumor. And then over their half-life, which in total is about 12 hours, they will move deeper and deeper into the tissue, and they will release those alpha particles as they go, as they diffuse deeper and deeper into the tissue. And so again, what we'll do is we will inject a number of these sources into the tissue. They are left in there with the radium trapped onto the surface.
As the radium breaks down and its daughter atoms move into the tumor, so those isotopes, which are themselves alpha emitters, they will diffuse deeper and deeper and deeper into the tissue before they run out of steam. And so now we've extended the range of the alpha particles, not because they travel any farther, but because we're releasing them deeper in the tissue. So instead of those 40 microns, which is really useless, we get about four to five millimeters of range. Again, that's something we can do something with. That's quite a bit more useful. We can put a number of these sources into the tissue in a way where we can basically sculpt, as it were, where the radiation goes. So we know that we're covering exactly where we want it to, but outside of that range, we don't really see any meaningful radiation at all.
And so again, we're getting a very well-defined, very well-sculpted dose of radiation exactly where we want it. So we need to figure out where we want to take this because, again, we have a treatment that we think is really relevant to any solid tumor, as long as we can figure out how to get there and inject into it. And so we've come up with three core focus areas. The first one that we started with is called localized and unresectable. These are tumors that have other options, like skin cancer, like prostate cancer. But really, for us, the focus is on those later-line patients who have tried surgery or radiation or both and are finding that they're running out of options. And so we started here, for example, in superficial tumors, tumors of the skin or the head and neck.
We started here because it was very easy to inject right into them and to see and control where you're putting it. We can monitor easily for side effects because you can see the tumors in the skin. So when we had good preclinical data, we started moving into humans. We've treated hundreds of patients so far, of tumors so far. We've seen very, very strong safety profile. Again, you don't tend to see the systemic side effects, the nausea, the fatigue, the vomiting that you normally see with radiation because the radiation is being really trapped in the area where we're dosing it in the tumor. What we tend to see are mild side effects, Grade 1 or Grade 2, mild to moderate, some itching, some swelling, et cetera, in the area of the treatment.
And again, it's easy to manage, and it goes away pretty quickly because the radiation is gone in about two weeks, so we've already gotten approval in Israel, which is where we started treating, where we started testing this. We've also submitted for approval in Japan, as I mentioned, for head and neck cancer, and we expect to hear back in the next few weeks. Really, our focus, though, is on the U.S., where we hope to bring this to market first with our biggest commercial launch as soon as, once we get approvals there from the FDA, and so just to show you a bit of the data here, we did a U.S. pilot study led by Memorial Sloan Kettering Cancer Center in New York. We took 10 patients with these stubborn recurring skin cancers. This guy, for example, has a tumor on the nose that's regrown after surgery.
To try and give surgery again will be very deforming for his nose. Instead, we inject the Alpha DaRTs, and you can see here, three months later, the tumor is gone, the nose looks great. There was no need for a very drastic treatment for this patient. In this trial, we saw a 100% complete response rate. Every single tumor we treated disappeared, and no serious adverse events related to the product. So an A plus as far as a trial can go, and it was published in the Journal of the American Medical Association. Now we're in the middle of that pivotal study. As I mentioned, this is our last study, we hope, for FDA approval in the skin.
We're taking these recurrent SCC cases in the skin, those ones that are coming back after surgery or radiation or both, and we are treating them looking for both the response to the radiation and durability of the response at six months. We've announced that we hope to finish treating patients in Q1 of 2026, and then we would look to get that durability data six, seven, eight months later. So looking at second half of the year, hopefully around Q3, when we would try and get the data and then ultimately submit it to the FDA for approval. Now, obviously, there are a lot of skin cancer cases a year, about 1.8 million new cutaneous SCC cases a year. We're not going after most of those. Again, in this pillar of our strategy, we're looking at the most difficult ones.
The literature indicates that about 3.5% of cases will have local recurrence or spreading to the nodes around it. Those are those stubborn cases we're going for. 3.5% of 1.8 million, of course, is about 64,000 cases a year. That's a time that we're thinking of, again, really focused on the highest value patients where the other therapies have failed. Similarly, we just announced last week, we got FDA approval for another study in the U.S. It's actually our fifth concurrent IDE, our fifth concurrent trial approval in the U.S. Just shows you how active we are in studies, what a fantastic dialogue we have with the FDA, and we're very privileged to do so, to be able to get our fifth trial approval. That one is for locally recurrent prostate cancer.
Again, in this pillar of our strategy, we're looking at indications that have other options, like prostate cancer, but when patients have resections, they have radiation. When they start recurring locally, the ability to treat locally without having to take out the entire prostate or without having to really provide these devastating side effects that have all sorts of implications, removal of the damage to the urethra or potentially sexual or urinary side effects. If we can test this here and see whether our focused radiation may be able to offer a better later-line therapy for these patients who need a focused salvage therapy for their local recurrence, and so it's another program we just announced is underway, coming off of some initial studies we've done elsewhere in the world as well. Very excited to get this underway in the U.S. Second pillar of our strategy is the metastatic patients.
And so we've seen quite a bit of evidence that where we treat a tumor, not only do we seem to destroy that tumor, but also really to catalyze systemic anti-tumor immunity. So we've seen a bunch of different evidence where we treat a tumor, and that somehow seems to help the immune system pick up on those tumors elsewhere. We've seen this in preclinical work, for example. We will treat mice, and they will become immune to that cancer, but susceptible to other cancers. We can show that we can activate checkpoint inhibitors. Mice that are not responding to checkpoint inhibitor immunotherapy looks like they will respond when we give them the treatment. We can actually see T cell proliferation under a microscope. We can see T cells being generated in the areas that we treat the tumor.
But most importantly, we see evidence like this where we treat a patient like this one over here. This woman came in in Italy, had multiple tumors on the legs. The doctors treated a three-centimeter lesion. You can see here a month later, the tumor has gone completely. What you see is just a stitch from a biopsy looking for cancer, but not finding it. That was a complete response. The doctor said, "Let's now measure the other tumors on the other leg and schedule the patient for the next treatment," and yet they found that the untreated tumors had spontaneously disappeared, and so we've seen a number of cases like this where we treat a tumor, and even without any other treatment being given to the patient, suddenly we will find other unrelated tumors in the body, distant tumors disappearing.
And so we want to know if we can harness this. And so we actually ran a very interesting study, a trial with Keytruda, which is Merck's $30 billion or so checkpoint inhibitor blockbuster drug, which is designed to unleash the immune system and allow it to find tumors. It removes the checkpoint that's stopping the immune system from finding the tumors. Now, the issue is, even when you unleash the immune system, four out of five patients won't see benefit because the immune system doesn't know where to go. And so our question was, when we do this spotlighting of the tumor with our focused local treatment, can we somehow have a synergy here where we can direct the immune system where to go by really focusing it on these tumors? So we built a study that was built around Merck's KEYNOTE-048.
That was a study that got Merck approval in the head and neck for metastatic patients. So same patient population, same design. We just added in the Alpha DaRT into a treatment, into a tumor. And the question was, if Merck showed 19% objective response rate, meaning any response systemically to the treatment, and 5% having a complete response rate where all the tumors in the body disappeared, can we show that by adding in a treatment of Alpha DaRT to a tumor, I don't care if that tumor responds, that's not the focus here, do all the tumors across the body have a higher chance of responding to the Keytruda? And so we had some early data from earlier this year, some very exciting data where we had recruited eight patients into the study.
Two of them died very quickly before we got to treat and measure them, which is unfortunate. That's how it is when you recruit metastatic patients who are very sick. Of the other six patients, so every single one of them responded to the Keytruda, that's three CRs and three PRs. Half of them, half of the six, had a complete response, so very, very different response rates to what one expects from Keytruda on its own. Again, ostensibly demonstrating that we are able somehow to work with the Keytruda and generate that systemic anti-tumor immunity, and so we are discussing with the FDA now, are there ways that we can explore this more larger study in the U.S.? Again, as we think about potential future approvals in the ability to combine this with Keytruda or other checkpoint inhibitors.
Just to give you an example of what this looks like and why this is so exciting. So this woman, for example, who came in back in 2022 when she was diagnosed with a horrific tumor, you can see here it's in the jawbone as well as in the lip. This woman is 94 at the time, cardiovascular and dementia issues. Nobody is cutting out her jawbone at 94 years old. They can give her Keytruda, which has a one in five chance of a response and a one in 20 or so of a cure. It turns out she also had some metastases in the skin of the neck, and so we use those as a platform. So we inject these Alpha DaRTs in. You can see afterwards there's a bit of irritation. That's standard for us. That's okay. You can see here afterwards the tumors are gone.
Again, that's our bread and butter. So that in and of itself is not the reason for this study because we're used to that. What's exciting, though, is that this woman has been getting Keytruda in the background, and while we haven't touched the mouth, you can see this horrific tumor has now gone completely. And so this woman, last time we saw her over two years after treatment, still cancer-free, not taking anything. This is the dream. If you're a Merck, this is what you want to do, is to take these patients with these horrific metastatic tumors and get them across the body to disappear. And so we were excited to be a part of that.
And so as we think about the opportunity here, just in the head and neck, and we're looking at this effect across a bunch of tumor types, but in this study looking at head and neck squamous cell carcinoma, just in the U.S., there are about 54,000 patients a year. About two-thirds of them are recurrent or metastatic. They qualify for Keytruda, for example, but only about 40% of them get it because, again, with a one in five chance of a benefit and all the side effects that come with it, not obvious you want to do it.
But if we can show that we can increase the response rates and we're continuing to test this, then not only is it relevant to these guys, but really all of the patients who qualify for Keytruda or for these immunotherapies might have more incentive to do it just given the massive difference in the response rate. So that's another area we're exploring and a very big area of excitement. Finally, of course, is the patients with the unmet need, and I'll say this quickly in the interest of time. We want to see if we have a treatment that is indifferent to the nature of the tumor, can we help those patients who don't have any good options? So brain cancers, pancreatic cancers, et cetera. And so we did release some data earlier this year in the pancreas. We had seen good safety so far.
We saw good response and especially disease control, over 90% disease control in the patients that we looked at in that interim readout. We also looked at survival because patients asked, doctors and investors asked us, are the patients living longer? It was a bit hard to parse because the patients came from all different backgrounds, different line of therapy, metastatic or not metastatic, different stages. But what we found was that the patients really fell into a number of groups, and I'll just show you one example here. When we looked at the patients who were metastatic at diagnosis, so Stage 4, received chemotherapy called FOLFIRINOX as their first-line chemotherapy, which is a gold standard chemotherapy. So there, the literature says they should live about 10-11 months. That's the median overall survival for those patients.
When they came to us, they did chemotherapy, they failed it ostensibly, and then came to us. We found that from that same point in time, from the beginning of the chemo, when we were 15 months of median follow-up, we still didn't know what the median survival was because eight or 10 patients were still alive, and so again, we know it's more than 10 or 11 months, whether it's 16 or 18 or 20 or 30 or 50 or 60, we'll have to wait and see when these patients die, but again, as of January, when we looked at this interim data, it looks like the patients are already living longer than they were expected to, and so some very early data, but very exciting results.
We took this to the FDA, and they approved the study for us, which is for newly diagnosed pancreatic patients, 15 Stage 3 locally advanced, 15 Stage 4 metastatic. We're going to take that chemotherapy, give them the Alpha DaRT from the very beginning, and look at what kind of side effects do we see? How does survival look? Does pain get better? We've seen that pain has actually been a very interesting anecdotal response. It's a very painful disease. Pancreatic cancer is often diagnosed when the patient shows up with a lot of pain in the hospital. And so we have heard anecdotally that patients are telling the doctors they feel a lot better within a few days after the treatment, so we're tracking that as well. So this is a very meaningful study for us. It's a pilot study, like a phase II.
We hope to run this over the course of the next few months, again, finish treating patients in Q1, and then get that data later next year. Again, I will say we've seen fantastic recruitment here. The demand from the patients, from the doctor is there. So we're very excited with the way that study is going along. It's going very nicely. We also did announce last week that we have two presentations coming up from earlier studies in the pancreas that were accepted for presentation at the ASCO conference in the GI section coming up in January, ASCO GI. ASCO, of course, being the most prominent cancer oncology clinical conference. It's a huge honor for us to be there twice this year. We had one presentation last year, two coming up this year from the doctors involved in the trials.
Again, a lot of momentum here around the program, probably one of our most exciting programs. Finally, I'll say quickly, GBM, of course, is the next frontier for us. Glioblastoma is really one of the most deadly cancers. Survival is mentioned in months, and recurrence is almost for everybody, over 90% recurrence. So we are starting to treat in recurrent GBM. We've developed an applicator for one injection that can spin around and give multiple injections, multiple sources into the tumor to give a lot of coverage without so much invasiveness, and so we just announced yesterday our first patient that we treated in GBM at Ohio State University. We're all thrilled with the way that it went. Again, we'll have to wait and see how the patient evolves, but based on the initial treatment, very excited that it was done successfully. The applicator worked.
The doctors are giving us fantastic feedback, and again, we got above 95% coverage of the tumor, even though it's our very first time treating in the brain, so a very meaningful milestone just given this cancer is not the most prominent in the U.S., but it is incredibly deadly and incredibly difficult to treat, and so anything that can offer new hope here will be a huge promise for patients and for doctors, so wrapping it up, obviously, a lot of stuff that we're working on, where historically we started in localized and unresectable tumors like the skin, the head and neck, and now the prostate, we're broadening into combinations of checkpoint inhibitors, as well as really accelerating into brain cancers, pancreatic cancer, et cetera. Hopefully, these milestones make more sense now.
Again, looking for the U.S. study to wrap up in Q1 in treating patients and then the pancreas as well. Excuse me, the pivotal study in skin and the pilot study in the pancreas getting data later in the year. This one, of course, we just hit yesterday with the first patient in GBM. So again, look to see that study make good progress over next year. And then also looking for a PMDA response. I'll say very quickly to wrap up, we are currently focused on building out our manufacturing footprint around the world, operating out of two facilities that are small right now for clinical trials in Jerusalem and in Lawrence, Massachusetts.
But also just announced a few weeks ago, another big announcement, our first phase of construction of our commercial scale facility in New Hampshire finished construction and got the radioactive license, which is the biggest hurdle we need to clear to be able to manufacture there. So that was a wonderful outcome there to have that capacity now available. We're continuing to fit it out with equipment and validations, et cetera. But now that we've passed the hurdle of the radioactive license, we know that it's in our hands to really execute on the plants. And on the financing side, we've been public for about three and a half years. We had about $76 million in cash and deposits at Q3. Other than some one-off CapEx related to that facility in New Hampshire, our burn rate remains about $5 million a quarter.
And so we are very well financed, thankfully, to be able to, excuse me, to be able to continue to execute in the coming quarters, not stressed about financing, and really able to focus on execution and on generating data from studies. So I'm going to pause there. I know there was a lot of stuff to update on. And thank you very much for the patience. And Alex, I'm always open to any questions.
Great. Thank you, Raphi, for sharing a lot of this exciting information. Maybe we could start with yesterday's announcement. You just mentioned it, the glioblastoma first patient being treated. Can you talk a little bit about how easily is the dart incorporated into neurosurgery? And also, you already talked about how poor the outcomes are, but what's the potential for darts to advance the standard of care and change those outcomes?
Yeah, absolutely. So we did develop an applicator specifically for the GBM and for the brain. And let me explain why it's so unique. So I mean, just to give a quick couple of images here, the applicator itself is designed to fit into a standard biopsy needle, a stereotactic biopsy needle. And then what happens is once our applicator fits inside of it, a tube comes out at the end and at an angle, the doctor can push the source into the tumor, then rotate around the axis and do it again. So you get an entire coverage here, 360 degrees of the tumor. And then as they pull it out, they stop on the way and do another round and stop and do another round. So actually, this patient who received, I think, probably about 20 sources only had really one injection.
You go in once, you spin around and stop on the way out, spin around and stop on the way out. And so the idea was you want to, number one, you want to first minimize the amount of new equipment, new procedures for the doctor to do. And in fact, that's what we've done. We're fitting into the exact same biopsy procedure and the navigation that they do, and we're doing maximum impact and minimal invasiveness. And so that really speaks well to the brain, giving the sensitive area.
I think in the brain, unfortunately, where survival is measured in months, even the ability to demonstrate that we can, if we do, that we can deliver a treatment that doesn't have devastating side effects like many of the radiations that are out there and that is able to extend survival, then I think that would be meaningful on its own. There are other therapies out there that are trying to do this. You look, for example, at Optune from Novocure as one example, just on the basis, and I'm not denigrating it, just on the basis of two to three months extended survival, that was enough for them to start renting out their equipment at about $500 million a year in the States. So unfortunately, for these patients, even if you're able to show that you're able to shrink, if not destroy, of course, the tumor, which would be ideal, but you can extend their survival by a number of months, that would be very, very meaningful for them.
Great context. Thank you for sharing, Raphi. And I know you talked about the strong balance sheet. Earlier this year, you did a direct offering to further strengthen the balance sheet. Could you just sort of help us understand how does your current capitalization sort of align with all those milestones you shared? And sort of when could we expect first commercial revenues?
Yeah, absolutely. Look, there are obviously a lot of decisions ahead of us that will affect our burn rate and will affect if and when we need to raise more money. I would say the main point is it's not an area of too much stress at the moment because, again, as we continue to burn about a little over $5 million a quarter, again, other than some one-off CapEx on the facility in New Hampshire, so obviously, the $76 million sits us well, and again, as you know, we did take about $37 million earlier this year when we received some reverse inquiry from an investor looking to make a direct investment, and we did that at the market, and we're happy we did so so that now I sleep very well at night and not worrying about financing, now obviously, the decisions ahead of us may drive cash needs differently if we want to build more manufacturing capacity, for example. These are radioactive plants. You don't build them overnight.
You need to get a lot of approvals to be able to build them. And so it is important to always be forward-thinking, even if it requires a little more expenditure today, to make sure we're not caught later on without sufficient capacity. If we want to do a large study of a particular nature, those are the kind of, oh, obviously, launch decisions. Those are the things that might affect our cash burn. But certainly, for the near term, we have a tremendous number of milestones we expect to deliver with the funds that we have. And so again, not a major source of concern there for us right now. In terms of revenue, so we did, as I noted, we received approval in Israel, and yet we chose not to sell.
We felt that the price we would get in the States would be much more appropriate, and so we give it away for free in Israel in trials. Similarly, in Japan, we're hoping we'll get approval in the next couple of weeks, so fingers crossed there. Our focus, though, will really be on meeting any post-marketing surveillance requirements there because there will be some presumed requirements to treat patients, ensure real-world evidence. Really, I think the first big commercial launch we would target would be in the States, and so again, if we think about finishing our pivotal study treatment in Q1, getting data second half of the year and submitting, we have breakthrough designation in the skin in the U.S., which gives us the fast-track review. Earliest we get approval would be probably around, if not end of next year, beginning of 2027.
And so we could look to launch there and make a big commercial push in the U.S. That said, I think if things are going fantastically well in the pancreas and the brain and elsewhere, it is quite possible we'll wait a little bit longer and launch in those indications, just given how massive and how incredible demand is there relative to something like the skin. So earliest, I'd say for real push in commercialization would probably be 2027. But again, there is what I would argue is a bull case if we choose to do a little bit later just because of the ability to harness some of those really exciting indications that are coming right afterwards.
Great context. Thank you. And Raphi, maybe just to wrap things up, you've spoken a lot about the expanding trials and the relationship you've built with the FDA. You've spoken about systemic responses and how rare those are and how beneficial they can be, and one thing you didn't mention that I'll just point out, the stock is up about 50% in the last six months. For investors on the fence, it seems interesting, but they're not sure if the time is right. What would you say in terms of why now is a good time to invest or meet and continue the conversation?
Yeah, absolutely. Look, we can't express a view on the value, of course. We think there's a tremendous amount of value ahead of us, and I think we're still quite a bit under the radar, which is why we're doing these conferences and trying to get investors focused because I don't think we've had enough exposure until now, and that's something we want to change.
I do think that we're now at a really exciting time, so if we had met two or three years ago, we would talk about the skin cancer and what we're doing there, and we could debate that particular market on its own versus others. I think now that potential approval, first of all, in Japan, hopefully, we hope to be very soon. We'll have to wait and see, but even if you look at in the U.S., we've got the skin cancer approval, which is hopefully within touching distance. We hope to finish up that study next year and submit, and hopefully, it'll all look good, as well as the fact that after many years of talking about the broad applicability to the product beyond just the skin and the head and neck, we're doing it, so now we're in a pathway where we're actually treating these patients.
We're generating data. We've already seen some great data so far. Again, only strengthening the thesis that if it works in one place, it should work in another because it is direct local radiation. So that thesis continues to be our view, and we continue to prove that out and hope to continue to generate more data. But now we're in a pathway where we're taking devastating cancers like the pancreas, for example. And unlike some of our earlier studies, we're now in a U.S. pathway where we've chosen exactly which patients we want to go after, newly diagnosed patients, Stage 3 or Stage 4, with FOLFIRINOX, looking to generate survival data. It is much more used to what biotech investors are used to thinking about. I think it's much more down the middle of the fairway, and it's indications that everyone can relate to.
Everyone understands why, if there's good data that comes out in the future in the pancreas or in the brain, what a meaningful impact that is for investors, for doctors, for patients, for everyone. So I think we are at a very exciting time now. There's a lot of milestones coming up. Obviously, we hope the data will continue to be good. We're out there focused on execution. And if we continue to hit, we're running in all cylinders. If the data continues to be good, I think the sky is the limit. But we're at a very, very exciting time now for the company.
Thank you very much, Raphi. So I'd like to thank you as well for sharing the presentation, not just taking Q&A. And also thank everybody joining for spending time with us today.
Same here. Thank you, Alex. And really appreciate everyone's time. Appreciate the questions. They're great questions. I hope you all follow along. It's going to be a great ride. So thank you for the time.