All right. Hello everyone, thank you all for joining us during the Lytham Partners Spring 2026 Investor Conference. My name is Robert Blum, managing partner here at Lytham, and today Raphi Levy of Alpha Tau Medical will be walking through the company slide presentation. Quick reminder, Alpha Tau trades under the ticker symbol DRTS on the Nasdaq. Raphi, go ahead and kick things off. The floor is all yours. Thank you. Good morning. Thank you everybody who's joining us. This is an incredibly exciting time to be at Alpha Tau and share our story. I know it's been only a few months since we were here with Lytham Partners, but there are a tremendous number of updates, and I want to focus on those during the course of this discussion. I'll start off again just by setting the stage and saying that our most important trials are coming to a head over the coming months. I think it's a really exciting time to be in the company, some very important catalysts coming up. That will come up again during the course of this discussion. Again, think about these trials, our ReSTART study in recurrent cutaneous SCC for approval, our pancreatic cancer study in the U.S., which we call IMPACT, our brain cancer study in the U.S., which we call REGAIN. Again, three of the most important studies we're doing with some big updates so far and some very big updates coming in the coming months. Just to remind you, Alpha Tau is the only company doing local alpha radiation delivery directly into tumors. We're doing so using a direct injection into the tumor that releases radioisotopes and gives us a very powerful but very tightly controlled dose of radiation inside the tumor. As we know, alpha particles are much more efficient in the way they kill tumor cells, but they are limited because of their range. Beta and gamma radiation that are used today are able to cover large ranges, they are very inefficient, and they end up bleeding to the areas around the tumor and doing all that damage to the surrounding healthy tissue. Alpha particles, despite being much more efficient and attractive for use in killing tumor cells, are limited by their short range in tissue. Again, the way we've overcome this is by injecting a radioactive source directly into a tumor coated with radium-224. As the radium decays, its daughter products are then further released into the tumor and will diffuse further and further over the course of that six-step decay chain, releasing alpha particles as they go. While the alpha particles themselves have a very short range, the fact that they're originating deeper and deeper into the tissue allows us to get a much more effective, longer range here inside of the tumor, and therefore to cover a few millimeters at a time, injecting a number of these sources into the tumor. We've chosen to focus on three core focus areas. The product itself, we think, is relevant potentially to any solid tumor, but we started off looking at tumors that were localized, that had already failed other treatments. We know how to treat skin cancer, we know how to treat prostate cancer, but those who have tried other therapies locally and failed tend to run out of options very quickly. We have started there as a proof of concept, as you'll recall. We've seen hundreds of tumors to date. We've seen a very mild side effect profile. We don't see the systemic side effects around the body, the nausea, the fatigue, et cetera. What we see are really mild side effects or moderate side effects in the area of the treatment that tend to go away pretty quickly. As you'll recall previously, we're already approved in Israel for this product. I'm happy to announce that since we last spoke, we are also approved in Japan for treating head and neck cancers as well. It's very exciting to have that underway. We're now focused on our post-marketing surveillance requirements, like a phase IV requirement in Japan, looking to start some other trials in Japan as well. The other area of focus on, of course, is the U.S. We've had fantastic data there to date, and that remains our biggest focus for commercial launch, excuse me, is the U.S., given that's our most attractive market. Since we last spoke, actually just two or three weeks ago, we announced that we completed the treatment patients in our pivotal trial in the U.S. We now have finished treating all 88 patients in this study for the stubborn recurring SCC skin tumors. We expect to get data seven or eight months later, so towards the end of the year, we hope to have data there that we can submit to the FDA for approval. Remember as well that we have breakthrough designation from the FDA in this cancer, and we also were granted a rolling application, meaning we've already started submitting some of the modules of the application and will continue to do so over the course of the year. The goal is that by the time we get to the end of the year and have that clinical data from this study, we'll already have much of the application behind us in the rearview mirror and just move ahead with the clinical data. This program continues to move along very quickly. As you'll recall, we have a program to examine the use of the product in metastatic patients. What I mean is not treating a tumor for a metastatic patient on its own, but treating a tumor and generating an immune response and really making this local therapy part of how we treat tumors systemically. As you'll recall, we've seen lots of evidence of this in the past. We've seen that we can treat animals and make them immune to the cancer they were treated for. We've shown that we can activate checkpoint inhibitors in animals that are not previously responding. We've shown that we can actually see T cells proliferating in the areas that we treat. You can literally see on a slide the T cell population that's expanding when we treat these patients locally. I think what's most interesting, of course, has been the data in humans, where we've shown, for example, a patient that we will treat one tumor and the tumor disappears, and then when we go to treat the other tumor three months later, we find that the tumor has completely disappeared even though we didn't touch it. Right? Now as we've discussed in the past, we did a very interesting study where we gave the treatment in combination with pembrolizumab, Merck's KEYTRUDA drug, for patients who have recurrent unresectable or metastatic head and neck cancers, SCC. We built a study around the design that Merck used to get approval, the KEYNOTE-048, which was their phase III study for approval. We just added in Alpha DaRT into one of the tumors, and we asked ourselves, can we see a better systemic response rate to the KEYTRUDA versus KEYTRUDA on its own when we look at the tumors that we didn't treat. Normally, KEYTRUDA on its own is expected to generate a 19% chance of a response and a 5% chance of a systemic complete response where the patient is effectively cured of cancer. The question is. Can we do better when we add in one treatment into a tumor with Alpha DaRT, and we spotlight the presence of that tumor for the body and help it generate T cells, help it fight these tumors elsewhere in the body? Can we show that doing so in combination with KEYTRUDA will actually help the other tumors in the body that we haven't touched respond? We had interim data last year, as you recall, when we saw that three out of eight patients or three out of the six that we actually got to treat and measure had a complete response to the KEYTRUDA versus 5% expected from KEYTRUDA alone, and 75% of the patients, or actually 100% of the six that we treated and measured, had a response systemically where the tumor started shrinking at least, if not disappeared, compared to 19% from KEYTRUDA on its own. We've now announced since then that the final results from this study will be presented later this summer at a podium presentation of the American Head and Neck Society. We are, of course, very much looking forward to seeing those data and sharing them with others. It's a very exciting study for us. We are discussing with the FDA now a way to get a study, a large study, up and running in the U.S. for approval in these patients. This would be our sixth study in the U.S. if it gets approved. Finally, as you know, we spend a tremendous amount of time in tumors of the high unmet need, tumors of the internal organs that we don't have a good way to treat. We talked a lot in the past about the pancreatic cancer program, among the other programs that we're running. Specifically last year, we had some interim data from patients that we had treated in our first in-human studies. One of those examples is here on the page. We looked at patients who were metastatic and who had failed first-line FOLFIRINOX, and while they were expected per literature to survive 10-11 months on the FOLFIRINOX chemotherapy on its own, we saw that 15 months in as median follow-up, most of the patients were still alive, and we still hadn't reached the median follow-up. Again, fantastic results here that we took to the FDA. The final results from this trial are being presented right now at ASCO 2026. Again, some fantastic interim data we saw last year. As you'll recall, since then, we've added a study in the U.S. which is really focused on the paradigm that we care about, which is taking newly diagnosed patients and treating them with chemotherapy together with Alpha DaRT, looking for whether our ability to give a local focused dose directly into the pancreatic tumor, together with the systemic chemotherapy they're going to get anyway, will give them better outcomes than chemotherapy on its own without adding meaningful toxicity. That's our hope. Now, we announced recently that while the trial was originally scheduled to be 15 patients in each cohort, 30 patients total, for patients receiving FOLFIRINOX, we announced very recently that the FDA expanded this study to be 20 patients in each cohort, 40 patients total, and patients who are receiving either FOLFIRINOX or gemcitabine and ABRAXANE, those are the two standards of care for these patients. Obviously excited to see a bigger study and more patients coming in so that when we ultimately move into a pivotal trial, if these data look good, we can go after a broader label across really almost all the patients who are newly diagnosed. We expect to finish recruiting these patients next quarter and have those data available closer to the end of the year. Finally, one of our most exciting updates has been in glioblastoma. This is data we just released two weeks ago. Glioblastoma, of course, is one of the most deadly cancers, nearly 15,000 cases a year, and the survival rate is minimal. We have been running a study in The Ohio State University, which is designed to treat patients with recurrent GBM. The FDA originally said to us, "We're happy for you to treat 10 patients, but we want you to treat three patients initially, do it one per month very carefully. Let's make sure there are no safety concerns as you go through those first three patients. After then, if the patients look good and safety is okay, then we'll review your interim safety analysis and clear you for the other seven patients." Again, it's a straightforward treatment. It's a one-time treatment using our specialized applicator. The patients get standard neurosurgery monitoring and steroids after the treatment to ensure there's no edema or intracranial pressure. Other than that, there's no special standard of care here. We just read out the treatment responses from our first three patients. You can see here, these are a diverse set of patients, different ages, different types of tumors. The first patient came to us after their third recurrence, second one after two recurrences, and the first one after one recurrence. Again, getting a broad range of patients here. Maybe I'll quickly talk about the first patient who came to us in a very disparate state. Since 2024, he had been suffering from this glioblastoma. The first treatment he had was a standard treatment of gross total resection and then radiation together with temozolomide, so surgery with radiation therapy and chemotherapy. He underwent a LITT and a trial. He had another recurrence and had surgery again, and then finally had a third recurrence that came back to Alpha DaRT. You can see here, this gentleman has, on the MRI, you can see some enhancement here and some swelling here where the tumor is located. We've built a custom treatment plan using our special applicator that rotates and delivers this kind of overlapping umbrella pattern, as you can see here. This dosimetry calculation before the treatment very much matches the dosimetry that we calculated after the treatment, where you can see that the sources were delivered as expected. You can even see them here on the various imaging, where the dosimetry overlaps exactly with those sources and where we wanted to cover the tumor. Just as we expected. One month later, you can see that the sources are here visible on the graph, on the image, but what you don't see is any tumor. This patient no longer has any tumor, no swelling around the tumor, and also three months after treatment, remains in a complete response. This is a truly phenomenal outcome. You do not see complete responses almost ever in recurrent glioblastoma. This patient did fantastically well, and even when we looked just two weeks ago, interim data, had no adverse events to speak of, no toxicities of concern, and remained with complete response. Overall, across these three patients, again, we saw fantastic data. Two of the three patients had a complete response, so 67%, which is completely unheard of. Notwithstanding, of course, it is still early and we need to generate more data. The third patient had stable disease. His tumor actually grew and then shrank quite a bit and ended up 30% smaller than it started, which is considered a stable disease in this indication. We are very happy with that, and he may continue to shrink as we continue to monitor him. The only side effects we've seen to date that were with the product were seizures in patients who already had seizures before we treated them, already had a history of seizures, and they all recovered with standard steroids or antiepileptics. We're very happy with this outcome, and it's truly a phenomenal outcome for a very, very devastating and recurrent disease. We've submitted this to the FDA and are awaiting their feedback with the hope that they will then allow us to complete the other seven patients. Coming back again to the upcoming catalysts, as I mentioned, hopefully it's very clear now as to all the upcoming milestones in a very, very busy and catalyst-rich year for us. In our phase III, in our pivotal study in the skin, we finished treating patients. We expect to get the data towards the end of the year and submit for approval, and again, hope for a quick approval in light of all the accelerations and early submissions we've already done. Look for approval next year. In pancreatic cancer in the U.S. IMPACT trial in combination with chemotherapy, looking to finish recruit patients next quarter and then get data as well around the end of the year or early 2027. Finally, looking to finish up those seven patients as soon as the FDA gives us their blessing in the brain to keep treating the other seven of 10 patients, and then also get data later in the year, toward the end of the year. A very, very busy catalyst calendar alongside some of the other things we discussed, like the head and neck combination data, final data from the study with pembrolizumab with KEYTRUDA at the American Head and Neck Society coming out in the summer, et cetera. It's a very busy year for us. Finally, as you know, we've been public now for four years. We had $80 million in the bank at the end of the previous quarter. We remain well-financed for execution. Our burn rate has been going up very slowly as we increase our clinical trial activity. It's probably approaching about $25 million a year now. Again, with the $80 million in the bank, we certainly can finance all these very meaningful milestones that we just talked about and look forward to a very exciting and very productive remainder of 2026. With that, I'm going to stop. I'll say thank you very much for the time, and look forward to a great 2026 with all of you. Fantastic, Raphi. Thank you very much for that tremendous update here. Thank you everybody for watching. If there are any questions or you'd like to schedule a meeting here with management, please send me an email. That's Blum, B-L-U-M, @lythampartners.com. Again, learn more about Lytham, be sure to visit our website. Stay connected with us on LinkedIn for further updates and alerts on presentations such as the one here with Alpha Tau. Again, thank you very much for your participation, Raphi. Thank you to everyone for listening. Have a great day at conference here, everyone. Thank you, everyone. Have a great day.
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