Thanks a lot, Ben, and thanks to everybody for joining and for listening to us. We have decided to run this workshop after the press release of yesterday. A little bit of history. We were together mid-December when we reported the first interim analysis of the phase II-B trial of RAD 101 in patients with brain metastases with very encouraging early data. Now, yesterday we were pleased to add more patients to the analysis and to share the results of the first 20 patients out of 30-patient trial. We are now 66% of the data available. We are extremely pleased by the results. Having 18 patients out of 20, so 90% of the treated patients to achieve the primary objective is, of course, great news, you know, we couldn't wish for better than that, to be honest. Is it important that we are talking about patients where the standard of care imaging has some limitation? Not all the patients are coming to this study. We are talking about patients where the standard of care MRI is considered not good enough. No. You can call it equivocal results, unclear results. All the 30 patients of this trial have MRI results that the physician consider suboptimal. The fact that now with RAD101 you can have an additional imaging or diagnostic assessment that allow the physician potentially to better manage the patient and to decide what to do is of incredible value. We are very excited about the second interim results. Again, 18 patients out of 20, 90% positive alignment with the primary outcome is a very good result. I'm also pleased to share that in our trial of 30 patients, we have already recruited 27, and we have two patients that already has an appointment to be treated. We are on track to complete this trial as expected in the next two to three weeks, we say during the month of April. Big thank you from my side to the team of Radiopharm Theranostics and to all the investigator, physician, and support staff because the recruitment went extremely well. What does it mean to complete the study two to three weeks? Well, we will have between May and June the official results of the phase II-B, and based on these results, we feel confident already due to the interim analysis to prepare for a phase III registrational study. We will have an interaction with FDA around June or July of this year, but the interaction is not about deciding if we do or not a phase III. The interaction is to decide how to do it, to be aligned with FDA on the number of patient and on the design of the trial. But at this stage, with the data available, we feel very confident to accelerate all the preparation as we do have the ambition to be ready to start the phase III before the end of 2026. Overall, very positive. I'm excited about the results, but I think it's time to have the expert telling you what happened. Thank you, of course, to our CMO, Dimitris, and also to Dr. Kulkarni, that is a principal investigator of our trial. Some of the patient that you will see today are his patients, so nobody can be better informed than Dr. Kulkarni. With this, thank you again, and I hand over to Dimitris for a presentation, and we want to be sure we have time at the end for a Q&A. Thank you. Dimitris, up to you. Thank you, Riccardo. Good evening, everybody. Good morning. I'm Dimitris Voliotis. I'm the Chief Medical Officer of Radiopharm. I'm based on the East Coast in New Jersey in the U.S. It is my great pleasure also to have Dr. Harshad Kulkarni with me, who was already introduced briefly by Riccardo. Dr. Kulkarni is Chief Medical Advisor at BAMF Health in Grand Rapids, Michigan. He is a globally recognized key opinion leader for theranostics, nuclear medicine, and all things related to PET, SPECT, and additional diagnostic methods that have to do with nuclear medicine in general. We are going to... I am going to show a few slides that discuss the background of the study and the compound, and then we will have some examples of study patients that illustrate the value of our PET method in addition to the MRI. Brain metastases are frequent. Approximately 300,000 new subjects are diagnosed every year in the U.S. only. The early identification and treatment of recurrent brain metastases is an area of a very high unmet medical need because the standard of care, the MRI, is not very good in that context. We think that RAD101 has the potential to address this medical need. This study is stemming from a collaboration from Imperial College London. They have published positive phase I and phase II-A data that demonstrate tracer uptake irrespective of the primary tumor, and also a preliminary correlation between high SUV values and shorter PFS and overall survival. Our own phase IIb study is currently ongoing, recruiting patients, and we will have the readout, as Riccardo said, later in the year. The compound is shown here. It is a small molecule. It is selectively targeting fatty acid synthase, which is an enzyme that cancer cells use in the brain to grow in this lipid-deprived microenvironment. Targeting and disrupting fatty acid synthase can impair growth of brain metastases, but also make them visible. This is a first-in-class imaging study that we are running here, and we're the only ones at this stage of development in brain metastases. Why is that important? Why do we target lipogenesis? On the left side in the red circle, you can see here that cancer cells have the ability to pre-activate a lipogenic program, which means that once they go into the bloodstream and cross the blood-brain barrier, they end up in the brain where they can essentially create their own nutrients, fats, lipids to survive. That's a very unique ability that exists only in the brain by the cancer cells. This metabolic adaptation makes the cells more aggressive and resistant to therapy. This results in a very highly specific pathway that can be used to target and visualize cancer cells in the brain. This is just a very brief preclinical slide. On the left side, this shows you essentially that it is very stable in the heart, in the circulation, the liver, the plasma, and the urine. On the right side, the two arrows indicate the tumor to background ratio, which is important because it's much higher in this case, in this tumor model, compared to the FDG PET, which is using glucose. FDG PET is not very good in the brain because there's already a baseline glucose metabolism that is in the brain, irrespective of whether there's a tumor cell there or not. The background glucose metabolism is already too high to be able to distinguish the cancer cells. As we already said, this is a frequent event, unfortunately. Majority of the patients with brain metastases, as you can see in the pie chart in the middle, have a primary tumor of melanoma, breast cancer, or lung cancer. This is where the majority of the tumors come from. On the left side, you can see that the percentage of patients in these various tumor types can be very high. Up to 60% in melanoma, up to 50% in triple-negative breast cancer of the patients can actually and will develop brain metastases. On the right side, you see what happens when you treat those patients. The two most frequently used external methods are whole brain radiotherapy and stereotactic radiotherapy. WBRT is whole brain radiotherapy, and you can see here that it's significantly worse than stereotactic radiotherapy. The standard of care is either surgery or stereotactic radiotherapy, which is something like a Gamma Knife, for example. Oops. Okay. What's the problem with MRI? The MRI, if you look at A and B, is very good to distinguish and identify initial brain metastases. For scanning, for screening, and for diagnosing, it's very good. In panel C, when the patients are being treated, the vast majority of them will develop a relapse or a progression. That's where the MRI is really not good at, because the MRI cannot distinguish well between tumor recurrence or remaining tumor and what's called radiation necrosis. Radiation necrosis is developing in basically every patient who has some form of radiotherapy, stereotactic radiotherapy. On an MRI, it looks very similar to active tumor. The MRI cannot really tell us, well, how much of that tumor is relapsing and how much is there potentially that has radiation necrosis. We are right now in March of 2026, where the yellow flag is. The data out of the Imperial College London, the preclinical phase I, phase II-A have been published. We're almost done with the phase II- B study, and we will then engage into developing a phase III study and have the appropriate conversations with the U.S. FDA around what such a study will look like. We do think that it could be 150 or maybe 200 patients, which for a registrational study in oncology is really very effective and very small. This is a huge opportunity. Very briefly to summarize the existing or previously published phase IIa study in brain metastases out of Imperial College London. They looked at two cohorts of patients, 12 treatment-naive patients, 10 who were SRS-treated, and they were able to show that there's a high uptake independent of the origin of the primary tumors and that there is a high Pivalate uptake in all intracranial disease compared to the contralateral side. They had also very interestingly preliminary results that showed that patients with a higher SUV in the PET showed a particularly short overall survival and PFS, while the standard of care MRI was not informative for that. Very briefly, we're not gonna go through this whole thing, but this is from the phase II study on 22 patients. On the left side, as you can see here, treatment-naive and SRS-pretreated. There was a very good visualization across the board. On the right side where it says SUV max, you can see that the different tumors noted here in different colors, lung, breast, melanoma, and colorectal, all basically showed the same SUV max as well as the same or similar tumor-to-background ratio. Whether the patient's primary tumor was lung cancer or breast or melanoma or colorectal, it does not matter. They're all equally well visualized. That's the result that I already mentioned, where the SUV seems to be predictive of the outcome of survival in PFS. Patients with a high SUV, which indicates high metabolism and probably more aggressive disease, have a short PFS and a short OS, whereas patients with a lower SUV seem to have a better outcome. From a biology perspective, it would make sense, of course. These are preliminary results from the phase II-A, and, you know, we will see how that is confirmed in our study and then later on in the phase III. Obviously, that would be a major factor if we were able to use this as a prediction for the outcome. To summarize, as I said, this is an area of very high unmet medical need where standard of care imaging is not great at. We do think that RAD101, our compound, which we also call Pivalate, has the potential to address this need. The existing and published preclinical and clinical data demonstrate clearly that this works. We do have clinical proof of concept. The positive phase II data demonstrate the uptake in all subjects irrespective of where the primary tumor was. There is better differentiation of the pretreated brain metastases versus the MRI. Correlation between SUV and survival, as already mentioned. We are in the process of finalizing our phase II-B with the readout in the first half of 2026, and then in preparation of the phase III to address this gap in medical care. Already mentioned, there's no competition right now where in this stage we are at least. We would be alone out there with the potential approval, which would give us a unique leadership in the field, of course. Now we can discuss the second interim results from our ongoing study. The study is recruiting really well. We have very high site engagement. 27 out of 30 patients have been enrolled. There is a high degree of positive correlation concordance between the MRI and the PET. What this means is that all patients have suspected but not confirmed MRI. In other words, the MRI is equivocal or questionable or however you wanna phrase that. This is then a situation where positive PET imaging augments the results and supports the results from the MRI, providing the additional information that may be needed to treat patients again and treat them early. We do use longitudinal scans, meaning that patients, after they go into the study, they have follow-up over a period of six to nine months to establish the true standard, the true positive from the true negative frame rate. Thus far, our results underscore that there is really great potential for clinical usefulness, which is to determine whether there are active tumor cells in the brain after stereotactic radiosurgery and be able to detect them at an earlier time point compared to the MRI alone. Please keep in mind that when we talk about concordance, it is really basically the PET confirming a suspected MRI. The MRI by itself is not able to determine with certainty how much of the tumor is necrotic, how much of that is viable, or if there's any viable tumor. We can come in with a PET, and then hopefully be able to solve that puzzle, and as you can see, then give additional information that would help patients to be treated earlier. We have a few patients now and this is the study as we already mentioned. Sorry. 30 patients in total. It's a one dose with a tracer dose of 10 millicurie, and the endpoints are concordance as well as sensitivity and specificity. Let's go to the patients now, and Dr. Kulkarni, if you would like to talk about this is one of your patients here. Certainly. First of all, thank you for the kind invitation, Riccardo and Dimitris. As Dimitris and Riccardo also pointed out, really we are looking to meet that unmet need, which you know is not completely clear from MRI, and that can really have an impact which we'll present later. This is our first patient which we are presenting, patient with breast cancer, and as you can see, the MRI findings before the stereotactic radiosurgery, there is a big tumor in the right parietal as well as a smaller tumor in the right frontal lobe. After SRS, you can see that there is a lot of surrounding edema, which is quite clear on MRI. At the study visit, also you can see that there is really not that much of a clarity as to what regions are, you know, really viable tumor or they are more compatible with necrosis after the radiation, what we see very commonly. We did the RAD101 PET-CT, and you can see here, these are the PET-CT combined PET-CT as well as the T2 MRI findings. What you can see that there is a focal intense tracer uptake, in fact, with an SUV max of 3.7. Now, Dimitris showed the earlier slide that, you know, a higher SUV has a significant impact on the prognosis. That also tells us with a lot of confidence that, you know, there's a lot of viable tumor tissue, which is seen here. It's, I mean, very clear. It's not really the posterior tumor, but also if you can see, in the anterior side, that is upper part of the screen, you're also seeing a viable tumor tissue at the right frontal region. Next slide. This is another kind of side-by-side view of that particular lesion showing that, you know, the surrounding edema is quite clear, but within the tumor itself, you see a lot of hypointense tissues on MRI. Really, the radiation oncologist was not certain what amount is really a viable tissue or it's an ongoing necrosis. To add to that particular true positive, we also had a biopsy of this particular patient, and the tumor was confirmed on biopsy. Not only on longitudinal follow-up would it be another ground truth, but in this particular case it was confirmed by biopsy. Dr. Kulkarni, you know, when we talk about the biopsy, that's obviously the ultimate proof of that there is tumor, right? When you compare the MRI with the PET, the PET looks very clear, the MRI is questionable, and then, you know, the biopsy really confirms the PET. Is that what we are seeing here? Yeah, that's exactly what we are seeing here. Correct. Essentially in this particular case, because, you know, as you know, RAD101 PET-CT is an investigational study, so we need a truth standard to confirm that the findings what we are seeing on the PET-CT are actually true positive or true negative. That is actually our, you know, further endpoint. In this particular case, you know, biopsy is kind of that holy grail, where, you know, you can actually go inside and confirm that there was a viable tumor tissue remaining inside. That was confirmed by biopsy. Great. Thank you. Next patient also from your side. Let's go to that example. This particular patient had a non-small cell lung carcinoma, and you can see very well these are the MRI images on your left before a stereotactic radiosurgery of a tumor which is present in the left temporal lobe. After the stereotactic radiosurgery, what you can see here is that there is also surrounding edema, but there is a ring-forming lesion which is present over there. Again, the finding was again questionable as to do we have an ongoing necrosis or there is a significant viable tumor within that particular lesion. At the study visit, you can see some enhancement on the MRI, but again, with the overall size, it is really not possible to determine on the structural imaging how much of that particular tumor has actually an active tumor. If you see on the extreme right-hand side, we did a RAD 101 PET-CT, and you can see that corresponding to that particular region, we can actually pinpoint or localize which region in that tumor lesion also has a viable tumor tissue. In this particular case you can see a large edema, but also more on the lateral side and more on the anterior side. Anterolateral side of that particular, previously, treated tumor with SRS, you can see a viable tumor tissue. Go on to the next slide. Thank you. you. That's the next patient also from your side? Yep. I thought this was. Yep, correct. This is a different patient, again with breast cancer. You can see that there's also among others, there's also a right cerebellar lesion, cerebral lesion as well as lesion which is very close to the midline, and a large again lesion in the left temporal lobe, which is showing a mixture of edema as well as questionable viable/progressive tumor. The RAD 101 PET-CT demonstrates an intense uptake in that particular region, and you can not only confirm, you know, that there is a possible viable tumor in that particular region which is metabolically active. But you can also localize at what exact point there is a, what exact location there is a viable tumor so that you know the radiation oncologist can escalate that further stereotactic radiosurgery or a targeted radiotherapy to that viable tumor. Especially I would like to point out that cerebellar lesions are especially difficult to determine as to how viable they are, but in this particular case, the uptake above the background and above the contralateral side or the opposite side, it was very clear and suggestive of a viable tumor. Thank you. This is really a very nice example of, you know, how the metastasis, the questionable, you know, structure here in the cerebellum, which, you know, in the MRI does not look very clear at all, is then confirmed with the PET uptake here. The only thing that I would like to add here, this patient had seven different metastases in the brain, so it's really important for such a patient, of course, if you want to treat that patient to be able to identify the different lesions here, as you can see very nicely. This is the same region that we already discussed, where you can see the uptake in the cerebellum. I think, you know, the previous image was already pretty clear. That's another region of that same patient in the brain, where you can see again very clearly how this lights up. Let's go to the next patient, also from Ben. Sure. Again, this is a patient with breast cancer. You can see here the image of the MRI in the left frontoparietal region, which is demonstrating brain metastasis. After the SRS, again you can see a region of surrounding edema, but again a ring-forming lesion, which you cannot really say to what extent there is a viable tumor. This was a finding which is different from the previous MRI, and therefore questionable for an ongoing progression slash recurrence of the viable tissue. You can see here very clearly that, again, anterolateral to this particular tumor, you can see on the PET there is an intense uptake, which again is strongly suggestive of a viable tumor tissue. Thank you. We have two more patients. This is a patient from a different site now, and it is particularly interesting because you can see how misleading the MRI can be. As you can see here, this is a patient where there was a metastasis detected in September of 2024, then the patient was treated with stereotactic radiosurgery. We have this post-SRS scan in March 2025, which already shows this circular uptake lesion with the white rim, where again there is a question. Is that viable tumor or radiation necrosis? This is actually very typical for radiation necrosis. Then there is another scan two months later when the patient was studied in our clinical trial, and you see that the lesion has changed a little bit in the sense that, you know, both the internal necrotic part but also the, you know, the whole lesion has grown bigger, but the rim is getting a little irregular, right? Then there's a follow-up scan a month later, where you can see that there's just a very irregularly shaped thin white rim around the central necrotic part. You know, I think, you know, help me here, Dr. Kulkarni, this is probably typical of what radiation necrosis looks like, right? Yeah, totally agree. I mean, this is a classic real-world scenario, more real-world than some of our previous cases that we saw. Here you can see that, you know, there is enlarging. There's this typical, you know, what we say doughnut sign with increasing central necrosis on subsequent scans. Really, the longitudinal follow-up is again here supposed to be that standard of truth, which will further confirm. Again, with so much central necrosis you don't really, you're not really certain to what extent is that particular metastasis that you treated with SRS has metabolically active tumor. If we would be looking at the MRI alone, you know, this is probably something where you would say, "Hmm, I mean, if this is necrosis, we wouldn't treat that, right?" At least not at that time point of June 25. Correct. Now comes the cool part where the PET really shows that there is a very strong uptake actually at that same time point of May 25, which is a studied date. You can see that's a very strong uptake here. There's a bright white rim around this, you know, central necrosis. You know, again, on the left is the MRI, which is what I have shown you earlier, which is more indicative of necrosis. The PET, you know, is very strongly suggesting that there is actually active tumor. Guess what. The patient received a biopsy, and it was confirmed that there was actually active tumor. Again, the MRI here is misleading from the perspective of not being able to determine active tumor and thereby also, you know, not giving too much information for the question of retreatment. The PET shows, you know, a much earlier positivity and would indicate that the patient could have been treated earlier. Any comment here, Dr. Kulkarni? Yeah. I mean, as you rightly pointed out, I think, I mean, usually in these situations, you know, people always ask, you know, what is really the impact of demonstrating that there's viable tumor? Most, you know, physicians would either delay the treatment or, as a diametrically opposite, you know, variant is overtreat that particular. If you have a modality, a molecular imaging modality which is giving you that answer and increasing your confidence. A, it will avoid unnecessary treatments, and B, which is probably most important and very valid in this particular case that you know the recurrence could be identified at an earlier stage and the relevant escalation to that local therapy could be done at a much earlier stage, thereby lending you know significant survival benefit also to the patient. Thank you. Last patient here. This is another patient with non-small cell lung cancer. You can see here that, you know, this is the historical scan prior to the stereotactic radiosurgery. This is after the stereotactic radiosurgery. The question was in June when the patient was enrolled. No, I believe the patient was enrolled in actually September. Sorry. The question becomes here, you know, is this actually active tumor? Because again, what you can see here that, you know, there's this irregular formation with this white rim that is more indicative of necrosis, but the PET clearly shows that there's active disease. Once again, I believe the PET here confirms that, you know, where we think there is necrosis, and we don't know if there's active tumor, that in effect there is tumor there. Since the lesion is still relatively small, that's maybe a good time point to treat these patients and not wait until this lesion has grown bigger, right? Absolutely. Thank you. This is all that we have in terms of the patients. I've shown you this slide, but maybe Dr. Kulkarni, just give us, you know, from the perspective of the clinician and the, you know, key opinion leader and, you know, thought leader in this space, and, you know, you see those patients, they're being treated at your site. You know, give us your take on, you know, how this can be summarized and the value of this. Yeah. Certainly. I mean, I would like to say two or three points. So, number one is based on, you know, what you've pointed out here with the study, you know, has been recruiting quite well, which we initially had also questioned. So, you know, there's definitely an unmet need in the real-world scenario where, you know, the radiation oncologist after treating that particular patient has, you know, uncertainty on MRI and needs more information to guide the situation, to guide the decision-making. And with the molecular imaging or metabolic imaging in this particular case, as you also, you know, pointed out, the high concordance. I would say that, you know, it is definitely tending. So far the findings what we have seen it is there's a tendency to demonstrate that the metabolic imaging or RAD 101 PET CT is really satisfying that particular insufficiency or insufficient findings on MRI, and that could have potentially a significant impact on the treatment management. At least in most of these cases, what I've seen at our site, what we have seen is, you know, the findings have been in most cases lent a significant finding over and above what the MRI. Look, here, what we are not seeing is MRI is definitely gold standard. MRI sets a very high bar in structural imaging. We're not looking to replace MRI, but certainly there are certainly in cases where, you know, in post-treatment scenarios with radiation necrosis is very, very common or almost we see in, you know, nine out of ten cases, probably, you know, in those disease settings, I see a value also in a post-FDA approval world, for the use of RAD 101 PET-CT. Thank you very much. I couldn't have said it better, so thank you. Yeah. We are really very happy about the results. We think that, you know, they could provide tremendous value for patients and treating physicians, and we're really looking forward to finish this phase II and get the phase III going. This is going to be a really important development. Thank you very much, and I believe we're open for questions now, right? Yes. Thank you. A number of questions have come through, so I'll kick off now. First one is two parts to this one or maybe three. Could you highlight how an equivocal finding on MRI versus confirmed metabolic activity on PET plus RAD 101 might change treatment decisions? And then further onto that, when judging sensitivity and specificity, what result do you need to be considered successful on these endpoints? Is superiority to MRI necessary? Thank you. I mean, I think we partly at least already answered this. I'll repeat. When we talk about equivocal findings on the MRI, it's what we said, right? There is a suspicion that the patient may have relapsed disease, right? It's not clear 'cause the MRI is just anatomical, right? The PET provides function. The PET shows you if there is metabolic activity, and that's really the supplementing piece of information. The question about treatment is, can we identify active tumor earlier than by just waiting for the MRI to get worse, and by that, you know, give SRS a better chance to prolong survival? When you treat those lesions early enough, when they're smaller, obviously, you know, there's a bigger chance to, you know, to catch them, to treat them, to hopefully resolve the issue. You know, this is not so much... What we need to establish the true negative and true positive rate is a combination of either histopathology if there's a biopsy or the long-term you know what we call the longitudinal scans. In other words, you know, patients that are follow-up six or nine months, if that lesion grows and shows further signs of active tumor, then we consider that the true standard. Of course, you know, as you can see for the two patients that had the biopsy, that's obviously the gold standard, right? I mean, there you have the positivity of the PET just you know right away confirmed. It's more about augmenting the PET, if you wanna say that. I'm sorry, the MRI through the PET. You know, we will be using the MRI always, but the PET gives you that additional information that is needed to say, "Okay, what looks questionable on the MRI is definitely active tumor, and then you should treat now and not wait." That's the part where, you know, it supports or augments actually questionable MRI findings. Next question. All right. Thank you. You might already be comfortable with what you've already said about this one, but I had someone ask if you could expand on the two patients who did not show concordance with MRI. What is the potential for why that was? Both patients, we don't have the scans here, but both patients had questionable lesions in the cerebellum, which as Dr. Kulkarni already said, is really difficult sometimes to image. Those lesions were very, very small. Again, it was unclear if that was tumor, right? The PET did not show metabolic activity here. It could well be that those are not actually active tumor lesions. You know, since you could see, they were very small. Very small. Just a few millimeters in size. You know, these are questionable tumor, and it could be that, you know, there is no viable tumor there, and that would be, you know, what the PET would show, that there's no metabolic activity. We just have to wait there to see if those lesions, you know, end up being positive in the in the MRI or more positive or true. But right now it looks like, you know, these patients actually don't have metabolic activity. It could be that the MRI is simply a false positive. Yeah. I would just like to add on that particular thing because at least one of those were from BAMF and you know that could be what we are really saying is if there is a questionable lesion on MRI, it is not always positive. It could be metabolically inactive, which is what you're saying is true negative. I mean, we obviously need some truth standards, whether it is longitudinal scans and/or biopsy. But that's also equally important finding. It's not something even if it was you know an equivocal scan on MRI was not positive on PET. I wouldn't see it as you know negative for the study. That's also equally important that you know, the clinicians don't overtreat based on a suspicious lesion on MRI. So that would be my perspective in this particular case. Thank you. 100% agree. Yeah. Right. Thank you. Someone else has asked a couple of questions. Firstly, I'll break this into two. For the first one is around phase II, the second one around phase III. First part, can you confirm if the end of phase II meeting with the FDA is scheduled on the calendar? What key data and analysis will be presented to the FDA? And does it include sensitivity and specificity analysis of these 30 patients? And further to that, are biopsy data required to be presented as well? We don't have the FDA meeting calendared yet, but we will submit a request for a meeting probably in the May, June timeframe, and we will then have the meeting in July or August, around that timeframe. You know, it's not scheduled yet. Of course, we need to wait. You know, this is an ongoing study, right? We will need to wait for the final results for us to be able to do that. We are already working on the protocol, the protocol synopsis. We're also working on, you know, getting the CMC part of the equation, done. Actively working on all these aspects. What we will then discuss with the FDA is, of course, the protocol itself, the inclusion criteria, the patient population. The endpoints are pretty clear, sensitivity and specificity. We will have some information on these from the ongoing study, but the final information on the truth standard from the study will be only available by its nature because we have to wait for the patients to go through the six to nine months follow-up or have a biopsy. We will go to the FDA with interim results based on the primary endpoint and partial results from the secondary endpoint sensitivity and the specificity. We think that we can initiate the phase III trial towards the end of the year. Again, you know, the question is, when we think about phase III trial endpoints, what might be important from a health economics perspective. I don't think there is a difference between the medical need and health economics here or, you know, healthcare insurance reimbursement. You know, the question is, again, what we now repeated a few times, that we are essentially able to really provide clinical usefulness by telling patients and treating physicians earlier that there is tumor and that it should be treated, period. That's where we think this is gonna go. All right. Thank you. This one's probably for Riccardo. How many business development inquiries have there been on RAD101? We receive strong interest on this agent and we continue to receive strong interest, but I cannot really disclose how many companies and who is contacting us. What I'd like to say is that we ask a company, an external company, to perform an external assessment of the commercial opportunity of RAD 101, and this external company came back with sales forecasts of more than $500 million per year only in U.S. Now, this number will put RAD 101 in the top three of all the available imaging agent. It's a big product. Potentially, it's going to be important because the number of patient that can serve is very large, as Dimitris was saying, 300,000 new patient only in U.S. every year. Potentially it's an important development, but at this time I cannot comment more than that. All right. Thank you. Another question here. If a big pharma partner presents to be involved in RAD 101 phase III, how would that impact the timelines to commercialization? As Dimitris was saying, based on the conversation with FDA, we will have a better picture on the final number. Now, if the phase III number is around 150-180 patient, a potential partnership is not really helping with the timeline. It can help with the resources. The timeline we are preparing the phase III in a pretty accurate way in terms of site selection, presence across United States, CMC availability, and of course continue to work with our partner, BAMF, in that area of the United States. We are well-positioned to run the study in the proper way. We will be very open to any conversation with company that wants to be involved. At the end of the day, we ideally would like to bring this technology worldwide, and it's much easier to do if you have a partner than if a small company does it. Thank you, Riccardo. This person understands the binding to fatty acid synthase, but how do you confirm that RAD101 is detecting tumor? Well, only the tumor cells have that, right? I mean, non-tumor cells don't do that. The point is really that tumor cells need lipids to survive. The brain does not have those lipids enough, so the cells switch on their own metabolism. You know, think about it this way, you know you're hungry, you can make your own burgers just by drinking water essentially, right? You switch on your own food supply. That's pretty unique. The fatty acids, the lipids that are available outside of the brain cannot get into the brain because of the blood-brain barrier. The cells that get through the blood-brain barrier need to be able to produce their own lipids to survive, and that's what we're targeting. Only the tumor cells have that. Just one. I think, Dimitris, what probably the question I wanted to know, like how can you be sure. The biology is of course very, very robust and, you know, the kind of radiopharmacy is also very, very robust. I think that is exactly what will be proved by those truth standards. We need obviously data from all the patients, as you mentioned, Dimitris. You can really, you know, correlate those findings on RAD101 with what is actually true. Well, thank you. It's really, you know, the pathological fatty acid synthase is really only in the brain when there's brain metastases. Of course, you know, as we said, you know, you can see both the anatomical co-localization with this questionable MRI finding and then the PET results. It's very specific. Right. Thank you. Have you found in MRI false positives that have been proven negative by RAD 101 in this data set so far? Would we have sufficient data to see this by the top line readout? I cannot answer the question with certainty. Those two patients that we mentioned could be false positive for the MRI. Again, we have to wait until they have the six to nine months follow-up or a biopsy, if that happens, to be able to answer that question. Those two patients would be candidates for exactly that question of false positive MRI. Yeah. Right. Thank you. This will be the final question. We can get back to those we won't be able to answer. Does recent changes to FDA guidelines around rare and high unmet need disease having any impact on RAD101 development? Maybe I can start and then, Dimitris, to you. That's an important distinction. Brain metastases is not a rare disease. If we talk about glioblastoma, we are talking about 12,000-15,000 patients per year. Brain mets is 300,000, so it's 20 times more. Brain mets is not a rare disease, so it's not impacted by any change or redirection or guidance for a rare disease product. Please, Dimitris, go ahead if you have anything to add. Yeah. It really has nothing to do with rare diseases. You know, if we can go back to slide number six, that's what we try to say. This is not a rare disease. It's frequent. Breast cancer is not a rare disease. Lung cancer is not a rare disease. You know, melanoma is not a rare disease. 60% or up to 60% of melanoma patients and up to 50% of, you know, breast cancer, in this case triple-negative, can develop brain metastasis. It's by no means a rare disease. It's frequent. It's a big medical problem. That's why the business case is so strong. You know, this notion, which I know exists, that brain metastases are rare, unfortunately, is not the case. You know, that's why, you know, we're trying to point out the high number of patients that are affected by this. Well, thank you. That concludes today's webinar. Thank you to those who presented today and also for everyone for attending. We will do our best to get to all those that we didn't get to answer the questions. Thank you again. Thank you. Thank you. Thanks, everybody. Thanks so much. Thanks, Pardon me. Take care.