Hello and welcome to the 44th Annual JPM Healthcare Conference. My name is Max Marks, and I'm an associate on the Healthcare Investment Banking team here at JPM. And today, it is my pleasure to introduce Raphi Levy, CFO of Alpha Tau Medical, who will be presenting.
Excellent. Thank you, Max. It's a pleasure to be here. I'm joined, of course, by our CEO, Uzi Sofer, who's here with me. It's a fantastic year to be here at J.P. Morgan again. I hope everyone's had a productive conference. We've certainly had a busy one and quite a bit to talk about. In the past couple of months, the company's had a tremendous amount of news, which we'll go through as well, and I think we're standing in the front of a really transformational year for Alpha Tau, with quite a number of milestones that we'll talk about very soon. For those of you who aren't familiar, Alpha Tau has developed the only treatment we know of for local intratumoral treatment of cancer using alpha particles.
When I say local, I refer to looking at an image of a tumor and saying, "I want to treat that tumor or that tumor over there with surgery or with radiation," things we've been doing for years but have been unable to do so with alpha particles to date. And I'll talk about how it is that we've overcome those challenges. So we've developed an injection that's delivered directly into the tumor. It releases alpha-emitting radioisotopes into the tumor, and they diffuse into the tissue and release a cloud of alpha particles around the injection, which we have found to be an incredibly potent dose of radiation that's very tightly controlled and, as far as we can tell, might be relevant to any solid tumor. We've done this in preclinical work in around 20 different tumor types. We have yet to find a tumor type that doesn't respond.
We've been spending a tremendous amount of time exploring this across different tumor types, expanding the areas of clinical applications that we're looking at. In the U.S., for example, we have five currently approved trials in parallel, and we'll go through those. A lot of stuff going on. As I mentioned, 2026 is a big year for us. I'm looking on slide four right now. We'll talk about some of these milestones, and it'll become clearer during the presentation. We have really important data points coming up. First of all, we're hoping to hear back on a potential approval in Japan very soon, expecting to hear back imminently on a head and neck cancer approval request.
We are looking to finish recruiting a number of important studies over the coming quarter or two, whether that's our pivotal trial in skin cancer, whether that's our pilot study in pancreatic cancer, whether that's our feasibility study in glioblastoma. We are hoping to finish a number of those trials over the course of the first half of the year and look for data coming in the second half of the year. So let's talk about the technology for a second, starting on page five with the types of radiation that we look at. Today, more than half of cancer patients are getting local radiation therapy. It's a mainstay of how we treat cancer patients. And they're all doing it using gamma and beta radiation. Gamma rays, like X-rays, can be shot outside the body. They will penetrate tissue and go to the tumor, wherever it might be.
The problem is, of course, that they have that range because they keep traveling once they've hit the tissue as well. And so while one is able to reach the tumor, one also has to use a very high dose because of the inherent inefficient way in which gamma rays and beta particles kill tumors. And those forms of radiation will continue to reach healthy tissue and provide side effects and damage to that healthy tissue outside of the tumor. Alpha particles have exactly the opposite problem. Alpha particles are incredibly more potent, more efficient, more direct in the way they kill tumor cells. However, when we place an alpha particle emitter inside of a tumor, we find that we get 40-90 microns of range, which is about three to four cell depths. And unfortunately, we can't do anything killing three or four cells at a time.
And so this inability to get into the tumor with any reasonable depth of the alpha particles is the reason nobody uses them for local intratumoral treatment of tumors, even though we all understand that the treatment itself, the potency of the alpha particles itself, is such that it would require a much lower dose. And so we figured out a way to do this. We figured out a way to use these more potent alpha particles in treating tumors directly. The way we do so, as you can see on slide six, is using the inherent decay chain of radium-224. Radium will naturally decay six times before it stabilizes. It will release a number of alpha particles along the way. And while each one of them is going to be relatively short in range, we will look to have them released deeper and deeper in the tumor.
What we'll do is we'll take a tiny pin, a piece of metal coated and impregnated with radium-224. The radium is trapped right near the surface of that implant, such that when we inject it into the tumor, while the radium can escape and move around and do damage in the body, its daughter products, its decay chain, the rest of that chain with the isotopes coming out, will recoil off of the source of the tumor, excuse me, off the surface of the source and into the tumor, and those decay chains will continue to diffuse deeper and deeper in the tissue and release alpha particles as they go, so looking at the animation on slide seven, you can see here we're going to inject one or more of these sources into the tumor. We're going to leave them there with radium trapped on the surface.
As the radium decays, it's going to now see its daughter products move into the tumor. They will diffuse further and further away from the tissue. And as they do so, they will continue to release alpha particles. So it's not that we're getting the particles to move any farther. We're rather seeing to it that they originate deeper in the tumor. So as such, we're extending the range here from the four to five millimeters that is quite useless to, excuse me, from the 40 microns that's quite useless to about four to five millimeters. Four to five millimeters of range is quite useful for us. It gives us enough range to cover a meaningful piece of tumor.
It's short enough that we can sculpt where the radiation goes by choosing where to place these injections and, as such, defining very tightly where that radiation should go. We've been developing this technology now using different mechanisms for delivery into tumors. We have delivery mechanisms for getting in minimally invasive ways into the skin, the head and neck, the pancreas, the brain, the liver, the lungs. We're able to harness existing biopsy procedures, existing workflow and equipment already at the doctor's office and in the hospital to be able to load them with these injections and use them to deploy the injections for a one-time treatment into the patient. The treatment itself uses a very small amount of radioactivity.
As opposed to all the other radiotherapies you'll find here in San Francisco this week, all of whom are dosing their patients in millicuries, we are dosing our patients in microcuries, which, as you can appreciate, is orders of magnitude less, which means that we don't really need radiation protections. We don't need to be in a nuclear bunker with lead in the floors and lead in the walls. We can do this in a traditional procedure room. We can also ship this on DHL and FedEx as an accepted package. So again, it's a light enough touch that we're able to get a very potent and very conformal dose of radiation, even with a relatively low dose of activity. We need to figure out where we want to spend our time, just given how broadly applicable this treatment is.
And so we've thought of three core focus areas, as you can see on slide eight, where we've chosen to spend our time. Where we started off was what we called the localized and unresectable area. These are tumors that may have other initial first-line options, like skin cancer, head and neck cancer, prostate cancer. What we have found is that where patients exhaust the available local treatments to them, surgery, radiation, et cetera, we look to come in as a later-line therapy and see if we can offer them new hope. And so we started off in this area in superficial tumors, tumors of the skin or the head and neck. It was a natural place for us as a proof of concept because we can easily access these tumors with a direct injection. We can control where we're placing them and monitoring for side effects.
On the back of strong preclinical data, we've started treating these patients. We've treated hundreds of tumors. We've seen a very good, mild safety profile. Again, because the radiation is very tightly distributed, we really don't see material amounts of radiation outside of the tumor. And so we tend not to see the systemic side effects, the nausea, the fatigue, the vomiting that one normally sees in radiation treatments, because really the side effects are with the radiation trapped in the area of the treatment. We've already been approved in Israel for marketing this for squamous cell carcinoma of the skin of the oral cavity. As I mentioned earlier, we've also submitted for approval in Japan for head and neck cancer and are hoping to hear back imminently if we can get approved there. But really, our focus is to push forward the U.S. as quickly as possible.
We're in a pivotal study right now in the U.S. for recurrent cutaneous SCC that I'll talk about in just a minute. Just to give you a taste for some of the data, this data on slide 10 is from a trial we had run in the U.S., a small pilot study in recurring these stubborn skin cancers that are coming back after surgery or radiation or both. This trial was led by Memorial Sloan Kettering in New York. You can see here an example of a patient who has a recurring tumor after having surgery. Their neck surgery is going to be quite deforming for his nose. Instead, giving this Alpha DaRT treatment, we're able to obliterate that tumor. We see a complete response without any material cosmetic damage to the nose as well.
In this study, we saw a 100% complete response rate, every tumor disappearing with no serious adverse events from the product. Fantastic data that was published in the Journal of the American Medical Association. As I mentioned, we're currently running our pivotal study across multiple centers in the U.S., 86-patient trial looking for objective responses and durability of response at six months. We are targeting completion of the recruitment by the end of this quarter and then looking for data later this year. Again, as we have breakthrough designation in this indication, we would look to submit it for FDA approval and hopefully get a fast-track review because of that breakthrough designation. I'll also mention one of the things we've announced recently is that the FDA has been kind enough to grant us a modular PMA, meaning a rolling submission.
So we've actually already started the application here for approval, having submitted the preclinical data and are already receiving FDA feedback there. So as we think about what the implications are for our work in this indication, we aren't looking to go after every skin cancer patient. That's quite important to appreciate. Obviously, there are plenty of skin cancers in the U.S. The estimates show 1.8 million new cutaneous SCC cancers every year in the States, most of whom will just go for a simple dermatologist treatment and excision of the tumor. However, the literature shows that about 3.5% of those patients, of those cases, will recur locally or spread into the nodes around it. And again, we're looking for these stubborn, more difficult treatments, the ones that don't have a great solution available.
3.5% of 1.8 million is going to bring us to an estimate of about 64,000 cases a year that we'd look to target. The next area to think about where we spent a lot of time and seen some really unbelievable responses has been on the metastatic setting. And I don't mean treating a tumor of a metastatic patient. That's straightforward. What I mean is that when we treat a tumor, we see that not only can the tumor respond, but we can also trigger a systemic anti-tumor immunity, where the rapid and focused destruction of the tumor is generating ostensibly a wealth of neoantigens. These are being picked up by the immune system, as far as we can tell, helping it to fight these tumors elsewhere in the body. We've seen this in preclinical work in many different ways.
We've shown that mice that we treat become immune to the cancer that we gave them. We can't challenge them again and cause them to regenerate those tumors. We can show that mice that seem not to respond to checkpoint inhibitors will respond in the presence of our treatment. We can also see actual proliferation of T cells. We can look at a microscope and see that there are T cells of various sorts being produced in the areas that we treat. But most importantly, we've seen patients like this woman here who came into our trial in Italy who had multiple tumors in the legs. You can see her on slide 13. The first one we treated was a three-centimeter lesion. A month later, what you see here is a suture from a biopsy.
She has had a complete response on that tumor, as we can no longer find any detectable tumor there. However, when we go to treat the other tumor, we find that the other tumors have spontaneously disappeared. Again, we haven't touched the other tumors. The patient is not receiving any other therapy. As far as we can tell, even though the radiation has no range to get from one leg to the other, it would seem that the immune system has detected this tumor and picked up on it elsewhere in the body, and so we want to test this more systematically, and so what we've done is we've actually been running a study in combination with pembrolizumab KEYTRUDA for patients with metastatic or locally advanced and unresectable head and neck squamous cell carcinoma.
And what we've done is we've built a study around KEYNOTE-048, which is Merck's phase III study that got the approval for this patient population. So similar population, similar trial design. What we're doing is we're adding in Alpha DaRT into one of the tumors. So our goal is not to see whether that tumor responds as it normally is. Our goal is to see if the other tumors in the body will respond more likely to the KEYTRUDA when we have delivered that focused dose of radiation into a tumor and really helped the immune system hone in on it. And so we're comparing ourselves to the response rates from KEYTRUDA on its own.
In that KEYNOTE-048 study, they demonstrated a 19% objective response rate across the body, the tumors across the body shrinking, and a little less than 5% complete response rate in terms of cures for the patient, effectively disappearance of the tumors. When we read out interim data last year, what we saw was that out of the eight patients we had recruited, two of them actually died before we got to treat and measure them, which is unfortunate when you treat late-stage patients. Of the other six that we got to treat and measure, every single one of them responded. Every single one of them saw systemic responses to KEYTRUDA, and half of them had a complete response, which is an unbelievable outcome for these patients compared to what they would have expected using KEYTRUDA. Now, I want to show you what that looks like for a patient.
Looking on page 17, here's one case from this trial. This woman was 94 when she initially came in. As you can see, she had this horrific tumor in her jawbone and her lip. She's 94 years old. She's got cardiovascular and dementia issues. Nobody is cutting out this woman's jawbone at 94 years old. She's going to get KEYTRUDA and have a one in five chance of a response and a one in 20 chance of perhaps a cure. She also has some skin metastases on the neck. You can see that on slide 18, we've chosen to use the platform, the neck as a platform, ignoring the lip tumor altogether. So we've treated the tumors on the neck. You can see when we remove those sources, a bit of irritation. Again, a relatively mild side effect that we're comfortable. We see this quite frequently.
Three months later, the tumors are gone. Again, that's very standard for us. We're always happy to see that, but it's not particularly surprising. What's interesting, though, is that we haven't touched the mouth at all, and while she's getting KEYTRUDA in the background, this horrific tumor has completely disappeared, which is an unbelievable outcome. This woman, she came in two and a half years later, had been off treatment for over a year and had no evidence of cancer. This is the dream. You want to be able to take these immunotherapies and take these patients who are in desperate metastatic settings and just clear them of tumors, and if we can play a part in that, that's tremendously exciting.
Thinking about the market opportunity, just in this one particular indication in the head and neck SCC, there are about 54,000 cases a year in the States of that kind of cancer. Literature shows that about two-thirds of them have the criteria to qualify for KEYTRUDA, but only about 42% of them actually get KEYTRUDA as first-line therapy, and again, if your response rates are low, it's understandable why not everybody's getting it. If we can potentially contribute to the response rates to immunotherapies, not only are these 15,000 a relevant market, but we also should be able to help expand the relevance of this drug to patients who might otherwise not have gone for it, and of course, this is just in one indication. We've seen evidence like this, evidence of an immune systemic benefit from a local treatment across a number of cancer types.
This is just the first one we've been exploring and continue to be in discussions with the FDA around a larger study like this for head and neck patients in combination with checkpoint inhibitors. Finally, I'll talk about the, excuse me, the high unmet need. So if we have a treatment which is truly indifferent to the nature of the tumor, we should be going after the ones which don't have any good options at the first line. So GBM and the brain, pancreatic cancer come to mind. And in fact, we spent quite a bit of time going through these patients, going through these different types of cancers, treating tumors of the pancreas, of the liver, of the lung, of the prostate, of the brain, et cetera. I want to spend a minute talking about our data from pancreatic cancer. We released some interim data last year.
Since then, we continue to put out good data, including data that came out last week here in San Francisco at the ASCO GI Conference. When we looked at survival data, not only did we see from our earlier first-in-human studies outside the U.S. that we're able to deliver this in a minimally invasive treatment, the whole thing takes about an hour, and the patient can go home. Not only did we see very strong safety data, we were asked to look at survival, and we saw survival data for these patients. But the problem was that they were quite a diverse set of patients. In these studies, we were open to anybody who had non-resectable cancer. And it's hard to know what was the standard of life for expected survival for a group that heterogeneous.
But we found that almost all the patients in this interim analysis fell into one of three groups. And when we look at each one of these three groups, we see something very interesting. So one group was patients who either didn't get chemotherapy, wouldn't get chemotherapy, couldn't get chemotherapy. And here, the literature says that untreated pancreatic cancer should lead to about three to three and a half months survival. When we treated these patients with a relatively mild treatment that they're able to withstand, again, we saw seven and a half months of median overall survival in our interim data. The next group are patients who are metastatic, stage four, who had received first-line FOLFIRINOX and then came to us. Now, here, there's quite a bit of literature. FOLFIRINOX is a very heavily used treatment for these patients. Literature is pretty consistent.
10 to 11 months is the median overall survival. When we did this interim readout, we were already 15 months of median follow-up into this and still had not reached the median calculation yet for survival because 80% of the patients were still alive. So we don't know if it'll ultimately end up at 15 or 16 or 18 or 20 or 30 months. But the reality is, with all the caveats around comparing trials, we're seeing an unbelievable response here in looking to try to extend the life of these patients. Finally, we also have patients who were on second-line gemcitabine Abraxane before they came to us. Here, the literature indicates they should be living seven and a half to 10 months. But as you can see here, for this interim analysis, we saw 23 months of overall survival median, an unbelievable outcome.
We took these sets of data to the FDA, and we've asked them for permission and been granted permission to run a pilot study in the U.S., which we're now right in the middle of running today. This is a study looking at newly diagnosed pancreatic cancer patients who will get first-line FOLFIRINOX chemotherapy together with Alpha DaRT at the initiation of the treatment. We've got it divided into two separate cohorts: 15 patients with newly diagnosed locally advanced pancreatic cancer, stage three, 15 patients with newly diagnosed metastatic pancreatic cancer, stage four. Again, looking at safety, of course, but also overall survival, progression-free survival, pain. It's a very painful disease, and we've heard a lot of anecdotes about immediate pain improvements after the treatment. Looking at surgical resectability as well for the locally advanced cohort, can we shrink tumors and drive them towards a definitive surgical therapy?
Obviously, it's a massive market. That should be obvious. There's about 66,000 new cases a year in the States every year. 59,000 of them, or 87%, from what we can tell, are unresectable. And that's really the market we're going after. This trial has been running now. We started treating patients right around Labor Day. Since then, we've had fantastic recruitment, clinician interest, patient interest for an unfortunate reason, which is just there's nothing to offer these patients, of course. And so we've said recruitment's going very well, and we expect to finish recruiting patients around the end of this quarter, looking for data later this year, and again, using that data to get us hopefully into a pivotal study with the FDA. GBM is the next frontier for us, of course, a deadly disease, a very exciting one to be treating given the poor outcomes for these patients.
But also, hopefully, you can appreciate why our motto, the very tightly controlled dose of radiation that we hope will spare the surrounding healthy tissue, is ever more relevant in the brain. Where else do we see tissue where we're more worried about surrounding healthy tissue being damaged in the brain? And so we have a specially designed applicator we've developed for direct injection into the brain with a minimal amount of invasiveness. We just had our first patient a couple of weeks ago, which has gone fantastically well. The patient was treated with over 95% tumor coverage in the very first treatment, got up and went home the next day. We're thrilled with how it's gone, and we're looking to continue to treat those patients. The way we structured this trial is that the first three patients will be one per month at Ohio State University.
After we've seen hopefully clear safety data there, we'll recruit more quickly, going up to 10 patients, both at Ohio State University as well as at NYU in New York. And again, looking to finish the recruitment there in the first half of the year so we can hopefully see some data in the second half of the year as well. We are very focused on expanding our manufacturing footprint. We want to make sure that we have facilities to be able to manufacture for our treatments. Of course, this is a decaying product. It does not sit on the shelf. It is radioactive. And so we manufacture a personalized kit for each patient of ours with the appropriate number of sources and applicators for their specific tumor geometry and get it to the hospital just in time for use.
We're currently operating out of two facilities, one of them in Jerusalem at our headquarters, one of them in Lawrence, Massachusetts, just north of Boston. Together, they're clinical trial scale, probably about 800 patients a year, perhaps at most. Good for our clinical studies, not really intended for commercial scale capacity. We have been working on a commercial facility in Hudson, New Hampshire. We announced that we're building it in multiple phases to spread out our cash burn targeting about 15,000 patients of total nameplate capacity per year when fully built. We've announced very recently that that first phase of the three phases of construction has completed construction and very notably passed the state radioactive commission's licensing requirements, which is a very big deal for us.
That is the main audit we have to pass to be able to now bring in equipment, bring in radioactive material, and validate and get the plan up and running, so we expect to do so over 2026 in getting that supply available, commercial quantities of supply available for the U.S., so coming back now to where we started, hopefully, you can appreciate the number of things we're doing and what a momentous year 2026 is for us. We hope to hear back from Japan any day now. Fingers crossed for a positive result, of course, but waiting to hear their final answer. We could be approved in head and neck any day now, depending on when they come back to us.
In the pivotal study in the skin, we are targeting completion of recruitment in the next quarter, over the coming quarter, and then getting data later this year for submission to the FDA. Then we have the pancreatic cancer study we've discussed, which we also are targeting finishing recruitment around the end of this quarter and data later this year, and then GBM coming slightly afterwards and again looking for data even as early as later this year. A tremendous amount of milestones, both near-term in terms of regulatory and clinical trial accruals, and then some really important data readouts coming later this year. Financially, so I'll say we've been public for almost four years. We had just under $76 million in the bank at the end of Q3. Our cash burn has been incredibly lean and very carefully controlled.
So it's historically been around $5 million-$6 million a quarter, perhaps. There's some CapEx in there for the facility in New Hampshire. But again, even at those rates, you can appreciate why we've got enough money to run through the studies that are currently underway, run for quite a bit of time. And so we're fortunate to be well capitalized. And in the face of overwhelming investor demand, it's nice to be in a place where we really have not had to worry about that as much in terms of getting to some very meaningful execution and data milestones over the course of the near term. So with that, I will thank you very much for your time. And we'd love to take any questions.
Thank you. If you could wait for the microphone, please. One second. Thank you for the presentation. Just on how do you position the Alpha DaRT in relation to the other therapies in development? For example, I think in pancreatic, we're seeing a lot of excitement for RAS. And in cutaneous skin cancer, there are some new therapies such as PD-1 cytokine development as well. So just wondering, is there any subset of this patient population that your product is specifically well suited to, or is that basically just come down to clinical data comparison?
Yeah, it's a great question. Thank you. Is it on? It's good.
It's on. You can hear me? Okay. It's a great question. Thank you very much. I'd say a couple of things. First of all, we welcome any progress across these tumors. There's no doubt there's plenty of need for some new hope in a lot of these desperate cases. I'd say, first of all, what sets us apart is that we are truly agnostic to antigens, to mutations. From our perspective, it is a straightforward physics treatment. And so there's no concern for the particular RAS mutation as it might be or others in terms of choosing the appropriate patient population. And we continue to not see any distinction between the specific histology of the tumor.
I would also say, though, in many cases, we find these systemic therapies to be potential complementaries more than they are potential competitors in the sense that we can offer, we aim to offer a potent local therapy that may work alongside something that has more of a systemic targeting effect, whether that's a KRAS inhibitor, whether that's a radiopharmaceutical systemic alpha therapy, for example. You could hopefully appreciate why you might want to use a local therapy directly in the larger tumors and then rely on something systemic that may not be able to penetrate tumors and may at least adhere to the surface of an antigen, something like that, and be able to be of more value in some of the smaller tumors around the body.
Of particular importance, I would note, is that overlapping adverse events profiles tend to be the biggest issue, one of the biggest issues in combining therapies. And so we think that's the reason that we will be particularly relevant there. If you think about chemotherapy, for example, where we are currently running that pilot study in pancreatic cancer together with first-line FOLFIRINOX, obviously, FOLFIRINOX has some efficacy in pancreas but has a devastating side effect profile. And so the number of options you have to be able to add something onto it if you have overlapping AEs is very limited. Whereas in our case, given the local nature of the treatment, the local limited nature of the side effects that we see, there's quite a bit more flexibility to add it out there and add it on top of it.
And so again, I think there's a good reason to say that there's rationale for adding our local treatment on top of some of these systemic newer therapies to be able to give a mix of the focused local treatment into the primary tumor and then the systemic therapies, perhaps, for some of the metastases elsewhere in the body.
Can I also ask about the potential approval in the U.S., how does reimbursement look like? Is there some existing code that you can attach onto, or do you have to create your own? And how does that process look like?
So yeah, it's a good question. And it's something we continue to work through in our pre-commercial work. It will depend a little bit on which indication we talk about, of course. GBM is an inpatient procedure, so it gets reimbursed under a DRG, but they're quite generous. Outpatient procedures are reimbursed differently. We think that there are CPT procedure codes out there that we can leverage for a number of the indications that we're looking at for the doctor's work. We will probably look to pursue separate indication for the product, which may take us a bit of time to get approved, but will ultimately help us seek better reimbursement levels in terms of price levels.
Thankfully, we do have breakthrough designation in a number of indications, which is quite helpful in terms of accessing some of the more recent programs from CMS and others that give you more rapid reimbursement. In particular, in GBM, for example, we're in the FDA's TAP program, which is quite small. And I haven't seen people who are so familiar with it, but it's actually quite incredible. It's effectively a commercial accelerator that the FDA has developed for a very select number of products where they give you access to an advisory panel at your disposal, not only on regulatory issues, but also commercial issues as well, with actual external advisors and payers involved. And so we are involved in those discussions. There's no doubt that will be an important part and is an important part of our pre-commercial work, but we do think we can tackle it.
It's just something we will continue to work through as we get closer to approval.
Thank you. Also, one that we have coming in. You mentioned that you recently treated your first patient with glioblastoma. Can you talk a little bit more about that?
Yes. So just to remind the audience that this study is for recurrent GBM patients. We treated the first patient in December. According to the study design, the first three patients, as Raphi mentioned in his presentation, we will treat one patient per month because of safety. So we treated one in December. We already scheduled the second one for the end of January. And the third one will be in February. All of them will be treated in Ohio State University. Once we will finish the first three, then it's open recruitment, and we will add New York University to this study. Patient is doing very good. No side effect. He went home after 24 hours of the procedure. So far, so good. One patient.
Thank you. And can you talk about the data shared recently at the ASCO GI conference and what are the next steps in that program?
Sure. So we did have actually two separate presentations last week at ASCO GI from the primary investigators in Canada in the Canadian study. One was focused on final data set from the patients they were treating. Saw some great outcomes, very high disease control, very attractive safety profile, and again, 100% feasibility. Again, very much in line with what we've discussed earlier from the interim data. The other one was actually a look at some immune markers and inflammatory markers systemically across the body during that treatment. It's well known that radiotherapies tend to deplete the immune system. Lymphocytes are among the most radiosensitive cells in the body, and those longer ranges of the gamma and other forms of radiation tend to be quite harmful to the immune system.
And so one normally sees certain markers like neutrophil to lymphocyte ratios, platelet to lymphocyte ratios skyrocket as the lymphocytes are depleted. Whereas with the Alpha DaRT treatment, they saw no changes whatsoever of any significant nature in any of those immune markers. So there's a real immune- preserving element that they're observing here relative to what normally would have been expected for radiotherapy used in cancer. In terms of next steps, of course, this data has all been part of what we've been showing the FDA and really helped us hone in on the homogeneous and well-defined patient population we're going after, newly diagnosed patients with first-line FOLFIRINOX, and ultimately has brought us to the point where we are now, which is in the middle of that pilot study on a pivotal pathway towards potential approval.
Thank you.
I'm just curious. What's the half-life of the radioactivity?
The radium-224 is 3.7 days, and the daughter atoms is about 12 hours.
Do you do repeat insertion?
Yes. We can re-treat, and we are giving 2% of the amount of activity that the patient can get, so we can re-treat the patient again and again.
We have another one in the back.
Thank you. With respect to your upcoming decision anticipated in Japan, if it's positive, can you comment further on how you would actually proceed with reaching patients and commercializing?
Sure. So obviously, we're waiting to hear first what they come back with. We would anticipate that, as is commonly done there, we would probably have some post-marketing surveillance requirements where they would tell us we'd like to see real-world generation. You should be providing the product to patients and tracking them like a study, even in a commercial setting, and showing us, in fact, that data looks like it has in the past in the study. So that'll be our biggest focus. Of course, the U.S. has always been our biggest commercial focus for a large launch. But in Japan, of course, we will look to ensure that we will, if we get approved, we will look to ensure that we meet those PMS requirements and generate the data that is needed. That's going to be our first step, and then we'll take it from there, of course.
Thanks. And in terms of your skin cancer program in the U.S., how is that coming along? And what's the implication of the modular PMA you announced?
Yes. So we plan to finish the recruitment this quarter. And then we will wait for the follow-up. So we believe that we will submit the clinical evaluation report by the end of this year. We agree with the FDA that it's a PMA module. The meaning is that we have three submissions. The first one is technical file. The second one is manufacturing. And then the clinical evaluation report. We already submitted the first PMA module, the technical file. And we are already in discussion with the FDA and answering their question for this module. We believe that by the end of this year, we will have the last module with the data.
Thank you, and regarding the combination data with KEYTRUDA that you showed earlier from head and neck cancer, what are the next steps for that program?
Yeah. I mean, look, I think it's an incredibly exciting set of data that we've seen. It's a very different approach than what we've done in the past, which is a locally focused approach. This is one about taking the local therapy, make it part of a systemic solution. And so we are in discussions with the FDA now around how we can pursue a pivotal pathway here, what we look for as endpoints, what are we trying to drive here in these patients in a systemic response. But we are looking to submit a potential additional trial to the FDA for their approval, one that would look towards either a near-term or medium-term approval for that indication for the combination label with pembrolizumab or another checkpoint inhibitor.
Thank you. And you also mentioned that you've got a plant coming online in New Hampshire. How does that fit into your global manufacturing strategy?
Yes. So we have two factories today, one in our headquarters in Jerusalem and the second one in Lawrence, Massachusetts. Both of them are for clinical use. Our study that we are running, validation, preclinical use. We built a new facility in Hudson, New Hampshire. This is for commercial use. It includes a few phases. We just announced in November that we got the radiation protection approval from the States for the first phase. This facility, this factory for the first phase will be between 4,000- 5,000 patients per year. And the whole facility, we plan for about 15,000, 12,000- 15,000 patients per year.
Thank you. And sort of going back to the isotopes, how do you secure raw isotopes for your product? And has that been a challenge for you guys?
Yes. Very good question, so we are using radium-224. We are producing the radium-224 in our factory, so our raw material is thorium-228. We're buying the thorium-228 today from the U.S. Department of Energy here from the U.S. We have other options, and we're buying the thorium-228 in our scale and the amount that we need. We don't see any problem. The only thing is that we need to give an advance order to the U.S. Department of Energy and get as many as much we need, and right now, we are producing in Massachusetts, in Lawrence, Massachusetts, the generator, and in Israel and in the future in Hudson, we will generate the radium-224 from the thorium-228.
Thank you. And what is your go-to-market strategy, especially given the broad applicability of your product?
Yeah. I mean, that's a big question. I'd say for the crown jewels, the U.S. and the core indications for us, GBM, pancreas, etc. , we expect to do that ourselves. We spend a lot of time trying to be thoughtful about which are the points of call that we really need to get to in an efficient way to cover with our own sales force. Obviously, as you can appreciate, we're not going after niche markets. We have big aspirations, and we think that this belongs as a large independent company with its own sales force going after these various points of call. Now, we have already signed distribution partnerships, commercial partnerships in Canada and in Israel and are discussing ones in other countries as well where we may not choose to build our own sales force.
We have also entertained a little bit of dialogue on specific indications that we may not want to develop ourselves but have someone else develop with us. But I'd say the core of it, we believe that we can build an appropriate sales force that will be focused on Alpha DaRT in the U.S. for the main indications that we want to keep in-house.
Thank you. And do you have any closing remarks you'd like the audience to know?
I'll say, look, I just think that we're standing at an unbelievably exciting time. It's been a fun week here at the conference. So thank you to the J.P. Morgan guys for having us. It's been exhausting. But I think from our discussions with investors, it's clear that not only do they appreciate the meaningful amount of data points and news that we've come out with recently, whether it's the modular PMA, the prostate cancer trial approval in the States, the initiation of treating patients in GBM, the publication of data at ASCO GI, the license in New Hampshire. There's been so many things happening in the past few months. And I think more importantly, people see the meaningful inflection points ahead of us in the course of this year. So it's going to be a really exciting 2026.
I hope we're, as much as we've evolved over the past year, I think things will be vastly different when we come back next year. And I hope you guys will follow along for the ride. So thank you for the time.