Okay, up next, I'm going to sit down with Raphi Levy, Chief Financial Officer at Alpha Tau for a Fireside Chat. Please stick around. All right, hello everyone, and welcome to the Alpha Tau Fireside Chat. My name is Robert Blum, Managing Partner at Lithium Partners, and today I'll be moderating a Q&A discussion with Raphi Levy, the company's Chief Financial Officer. As a reminder, Alpha Tau trades under the ticker symbol DRTS on the Nasdaq. Raphi, welcome. Thank you. Great to see you. Thanks for having me. Absolutely. For those not totally intimate with the company, you know, give us a reminder summary of Alpha DaRT and how you're using it. Sure. So Alpha DaRT is the technology we've developed, the only way to deliver alpha particles directly into solid tumors. So we're going after local radiation. By local radiation, I mean you see a tumor over there in the image, you want to cut it out or radiate it. Today, the radiation is generally done using gamma rays or beta particles, which are an inefficient way to kill tumor cells in the way they work. However, they are useful in that they penetrate the body like X-rays and therefore are able to get to the tumor. Alpha particles are known to be much more efficient in the way they kill tumor cells, much more direct. We can use much lower doses. The reason nobody's doing it is because of how short the range is in tissue, on the order of about 40-90 microns, really enough to kill three or four cells, but not really of any useful clinical benefit. We've come up with the Alpha DaRT, which is a tiny injection into the tumor, a small pin coated with radioisotope Radium-224 that actually releases a chain of isotopes into the tumor. As those isotopes diffuse further and further into the tissue, they release those alpha particles deeper in the tissue and give us a much better range. Effectively, the idea here is that we can do this local injection into any solid tumor we'd like, hopefully, and deliver a very potent but very conformal dose of radiation using a fraction of the activity that would normally be used in a cancer radiotherapy. We think it's very broadly applicable. We've tested this in preclinical work in around 20 different tumor types and never seen a tumor type that doesn't respond, and so really now we're focused on developing a couple of key focus areas in the clinical setting to try this out across different tumor types. In one group of patients looking at tumors that have other options, where patients have already tried surgery or radiation or both and need a new local option at a later line where we have found that we can potentially overcome a lot of that resistance to other therapies. The second one is in treating tumors of high unmet need, like the pancreas and the brain, things like that. Finally, we've also seen evidence that treating a tumor not only seems to destroy that tumor or help ablate it, but also seems to trigger the immune system's recognition of that tumor and picking up and fighting that tumor elsewhere in the body. That's an area we're exploring as well with some really fascinating evidence there so far. Yeah, maybe talk about how your lead indication in superficial tumors progressed throughout 2025 here. Sure. Yeah, of course, as you know, we started treating skin cancers and head and neck cancers really as our first proof of concept. And the thought there was that when we're injecting this treatment directly into the tumor, so it was natural to start in the skin where we have easy access to those tumors. We can get to them easily. We can see where we're placing it. We can monitor for side effects. And so we've done quite a bit of work there already. In the past, we've published some fantastic results showing 100% or near 100% response rates in multiple trials across the world, very good safety profile. This year, 2025, really was focused on pushing forward our pivotal study in the skin. So right now we're running a pivotal study, a final study for approval, hopefully from the FDA in the U.S., looking at recurrent skin cancers of the SCC type, squamous cell carcinoma, patients who again have tried surgery or radiation or both and don't have good options. And can we show that we are coming in now and offering a better later line therapy for the patients who have failed these other options? And so 2025 has been a year of a lot of progress there in that study, bringing on new centers, doing this in the community. Again, because we don't need major protections here, we're dosing 2%-3% of what a patient can tolerate, orders of magnitude less than other radiotherapies. You don't need the same protections, the lead vest and the lead in the walls. And so it allows us to do this in community dermatologists and most surgeon settings. And so we have been bringing those doctors online, treating patients across the U.S. That trial is now wrapping up. So we are targeting finishing the completion of patient recruitment this quarter, Q1 2026, and then look to get that data later this year to submit to the FDA for approval if it looks good, hopefully. Talk about the implications of the modular PMA you submitted to the FDA recently there. Yeah, so on that, exactly on that program for the recurrent cutaneous SCC, so we will ultimately look to submit a PMA application, which is the pre-marketing authorization request for approval if the data look good. And what was interesting here is that the FDA allowed us to use a rolling submission. So rather than getting everything together and submitting it all at once, right, there's really three core elements to the application. One of them is the preclinical work we've already done in the past. The second one is the quality and the manufacturing of the product. And then the third one is, of course, the clinical data, the capstone of which is the pivotal study that we're running right now. So while we're still waiting to finish that pivotal study and get that data, in parallel, the FDA has said that we are okay to submit the other modules. And so we've already submitted that preclinical module, which allows us to begin that discussion with the FDA, have them review it while the clinical trial is still ongoing, get their feedback, and fill in anything else that's needed so that by the time we can submit the next module as well soon with quality manufacturing. And by the time we get around to finalizing the clinical data and submitting it, we'll already have gotten FDA feedback on the other parts and hopefully progress quite a bit more quickly there so that all that's left is the clinical data and to review that and have that hopefully be signed off for an approval. All right, very good. Let's transition here on the pancreatic cancer indication. You had some data submitted here, presented recently at ASCO GI. Maybe expand upon that just a bit. Sure. So there were two presentations given last week at ASCO GI by clinicians in our first study in the pancreas in Montreal. And so there are two core elements they wanted to show there after finishing up that study. First one was the final results from the study, which were very strong. The study was really geared towards safety and feasibility. Can we deliver our injections into the pancreas in a minimally invasive way? Can we do so safely without harming patients? We saw a very good safety profile. We saw 100% feasibility. Everybody was treated successfully as desired. And so very good outcomes there. But they also saw very high disease control, more than 80% disease control, which is a big deal in a very fast growing tumor like the pancreas. They saw above 20% responses already, which is fantastic. Again, in many cases, giving small amounts of radiation, suboptimal doses just to test the safety and feasibility, and already seeing very good signs of responses and of disease control in particular. The other thing they mentioned was that they had done some work looking at immune system markers. Radiotherapy is known to be a modality that tends to really destroy the immune system. In many ways, the lymphocytes are among the most radiosensitive cells in the body. And so often when treating patients, one finds that they end up suffering from depleted immune cells. And so what they did was they actually tracked a number of immune markers, which are negative prognostic indicators. They're indicators that tend to rise in a bad situation. They tend to have poor prognosis when those indicators rise. In the case of the Alpha DaRT, when they compared levels before and after the treatment, they really saw no significant change at all in those levels. The only thing that changed was that they saw interleukin-6, IL-6, which is a well-known inflammatory marker, and also high interleukin levels, high IL-6 levels are a predictor in some ways of poor responses to chemotherapy. So actually those levels came down by a hundredfold, right? A p-value of 0.00001 in terms of apparently an anti-inflammatory effect. Not only are they seeing that the Alpha DaRT doesn't seem to be destroying the immune system, it seems to be immune preserving, they also saw a very notable decrease in those inflammatory markers, again, potentially indicating an anti-inflammatory effect here and perhaps even supporting the body's ability to respond to chemotherapy. Excellent. Great update there. Again, sort of transition here, you also started recently in GBM as well. Maybe tell us a bit about that. Sure. Yeah, Glioblastoma obviously really one of the holy grails here. It's not a huge market, but unfortunately it's a devastating disease for those patients, and so we did start treating patients in Glioblastoma. It's very exciting for us. I think that for us, on the one hand, it's perhaps the scariest place to treat in terms of injecting things into the brain, such as sensitive tissue. On the other hand, it's perhaps one of the most exciting ones, given again, the very limited treatment options available for those patients, the very high mortality rates and short survival durations for those patients, and really the fact that our goal here, which is to deliver a very conformal, very potent dose of radiation and try to spare the surrounding healthy tissue, is ever more relevant in the brain, just given the sensitivity of any damage to surrounding tissue in those structures. And so we did have our first patient a couple of weeks ago at Ohio State University. Treatment went very well. The team is ecstatic by how it went through. In our first treatment, again, very conservative approach, just looking to see that we can deliver it successfully and safely to the patient. And yet they managed to get about 95% coverage of the tumor in that very first treatment. Patient felt fine, went home the next day. And so again, we'll keep monitoring, of course, and see how they do, but it's a very auspicious beginning for a trial that's very important for us and in a really difficult cancer. All right, very good. Let's sort of talk about the manufacturing side here. I know you have a plant coming online here in New Hampshire. How does that sort of fit into your, really, it's a global manufacturing strategy? Yeah, so absolutely. So at the moment, we've been manufacturing out of two smaller plants, one of them in Massachusetts and one of them at our headquarters in Jerusalem. And those are really sized for clinical studies. So together, maybe 800-1,000 patients a year of capacity at most. Again, really there just to be able to supply patients for clinical trials. As we get closer to approvals, we want to make sure that we have sufficient capacity for supplying commercial quantities. And so we did undertake a couple of years ago our first commercial scale facility in Hudson, New Hampshire. And then late last year, we announced that we're building it in three phases to spread out some of the cash burn. But in that first phase, not only did we finish the construction, but we also were able to secure the radioactive license from the New Hampshire Department of Health and Human Services. And so that's a major hurdle for us. It's really the main point that's outside of our control, right, that we have to be able to pass that audit on the radioactive side. Now that we've done that, the rest of it is in our control now for the most part. We can bring in the equipment, we can bring in the radioactive material, we can do the validations. But now really we know we can move ahead whenever we want to, having passed that major hurdle. So over the course of 2026, we'll look to finish that up in terms of bringing in the equipment and bringing in the radioactive isotopes, doing the validations at our own speed so that as soon as we have visibility on commercialization, we're able to get that quantity of manufacturing up and running. You know, on one of those points there, how do you secure the raw isotopes for your product? And has there been any challenges as it relates to that? Yeah, this has certainly been a major focus for people in the industry and the radiotherapy industry. In some other alpha emitters like Actinium-225, there have been real supply constraints. Thankfully, we haven't really run into issues there. We are buying Thorium-228, which is the feedstock that we use, which comes out of a number of different nuclear reactor procedures that are being done, excuse me, and we harness the thorium and milk it to generate the radium ourselves, which is then what goes into our treatment, so you have to keep in mind that the treatments we're doing are, again, a fraction of what others are doing in terms of radiotherapy, and that has, in terms of the activity that we're using, and that owes really to the fact that number one, the alpha particles are so much more efficient in the way they kill tumor cells. So you need lower activity levels, fewer hits to a cell to kill it. Number two, the fact that when the radiation stays in the place where you're giving it, instead of spreading to the areas around it, or in the case of a systemic radiopharmaceutical, spreading throughout the body, in our case, you're keeping it really where you want it to, and therefore you can use a much lower dose because your dose isn't being diluted by off-target areas. So where other radiotherapies are dosing in millicuries, which is a unit of radioactivity, we are dosing in microcuries, which is obviously orders of magnitude less. So the supply we need is quite a bit less. We buy supply in millicuries, again, which is what others use in many cases for a treatment we use in terms of our supply quantities. We've been buying it from the U.S. Department of Energy in Oak Ridge, Tennessee, but we've had discussions and in some cases engagements as well with other suppliers. And we don't foresee any major issues there at the moment. Okay, great. Talk about the go-to-market strategy here, especially given sort of the broad applicability of the product. Yeah, absolutely. So I think for the crown jewels, for our core indications in the U.S., we would look to market this ourselves and build our own sales force. That's our current plan. And again, we've learned which are the doctors we need to focus on, who are the ones who would ultimately see the patients at the right point in time during their treatment journey and be able to prescribe this and ultimately potentially deliver it to the patient. And so we think we can use a manageable size sales force in order to reach the core doctors we want to target in each one of the indications that we're going after. We have already signed partnerships in Canada and in Israel where we would look to have someone else commercialize for us. We are in discussions in Asia about potential partnerships there as well to develop and commercialize it there. For the most part, I'd say the U.S., we're focused on going it alone. We could consider sharing certain indications that we think are really actionable and can be partnered out to somebody else if perhaps they're a little bit less core to us. For the most part, we do think that given the broad applicability and the fact that we want to go after some very big markets, this really does support a large independent company, right? There is a real viability for a company to build a sales force around a product like this, given how widely we think it can be used. We do hope to do so. All right, fantastic. Maybe in the final minutes here, talk about the key deliverables, milestones that investors should be looking for here in 2026. Sure. Yeah, there's a lot of stuff going on. So I'd say looking on the clinical side for completion of some of our U.S. studies, the pivotal study in the skin cancer and the pancreatic cancer, both coming in the Phase II or the pilot study in the pancreatic cancer in the U.S., both of those looking to wrap up in the first half of this year. And then data coming potentially later in the year from both of them. I think those will probably be the two main focus points are the U.S. clinical study, pivotal study, excuse me, in skin cancer and the U.S. pilot study in pancreatic cancer. We'll also look to wrap up the GBM study later this year in the brain. So again, a bunch of things going on in parallel. And so just given multiple shots on goal, there's a lot of news flow coming over the next few weeks, months, and over the course of the year. Thankfully, we are well financed to be able to execute. Excuse me. We had $76 million or so in the bank and in deposits at Q3. We've been burning about $5 million to $5.5 million a quarter for our run rate operations other than some one-off CapEx for the facility in New Hampshire. And so again, we're pretty well financed for execution, just focused on generating some real progress and data across some of these core indications for us. All right, very good. Well, congratulations on all the progress made in 2025. Look forward to continuation of that here into 2026. So Raphi, we always appreciate you coming by and speaking to the team here and to the investors. To everyone watching, thank you as well for your participation. If there are any questions that anyone has in the audience here and would like to or like to schedule a meeting here with management, shoot me an email. That's blum@lithiumpartners.com. I'd be happy to help coordinate here. Again, Raphi, thanks so much for participation. Thank you. It was great to be here. Thank you, everybody who tuned in. All right, everyone, stick around. We have additional presentations and fireside chats coming up. Thanks so much. Have a great rest of everyone's day. Raphi, congratulations again on the progress made over the last year and your participation here today in the summit. Okay, next up, I will be joined by Quang Pham, CEO of Cadrenal, and Matt Boxer, the company's Acting Chief Scientific Officer, as we dive into the developments taking place at the company. Please stick around.