Hello and welcome to the Deutsche Bank Virtual Investor Conference, dbVIC. This is Zafar Aziz from the Deutsche Bank team. I'm pleased to welcome our next presentation from Radiopharm Theranostics from Australia. Before I introduce our speaker, a few points to note. Please click on the questions box to ask a question. All of today's presentations will be recorded and can be accessed via the Deutsche Bank website, adr.db.com. I'm happy now to hand over to Radiopharm.
Thank you very much for having me, and thanks everybody for joining. Radiopharm Theranostics is a company where the core business is radiopharmaceutical imaging and therapies. We are an Australian company, as we were created in 2021 in Australia, and we became public on the ASX in 2021. At the same time, almost the entire management team is U.S.-based on the East Coast, so we almost are all in the U.S. We also decided to be dual-listed, so since December 2024, we are also on NASDAQ with a ticker RADX. Let me take you through the key elements of the company. We really used the first four years since the company was created to advance our products from preclinical to clinical stage. We now have four therapeutic molecules in clinical stage and one imaging molecule.
From the beginning of the company creation, we have decided to differentiate ourselves in the radiopharmaceutical space. A significant number of companies are focusing on three mechanisms of action: PSMA for prostate, SSTR2 for neuroendocrine tumor, and FAP for multiple solid tumor. We took the decision to do something different and to focus on other mechanisms of action, just to give our contribution to potentially bring new radiopharmaceuticals in areas where currently there is no clinical development. In fact, you can see from the first bullet point that we are focusing on highly differentiated areas where we are either the first in clinical development or we are alone. Mechanisms of action like PD-L1, HER2, B7-H3 are well known in oncology, but they have been addressed so far through different modalities, either targeted therapy, immunotherapies, or ADC. We are the first one addressing them with radiopharmaceuticals.
In our area, it is extremely important to have a secure and redundant supply chain, and this is something that we have really built solid across the years. We also created two strategic partnerships, one with an industrial partner and one with an academic partner. Lantheus is one of the key players in radiopharmaceuticals, is one of the leaders, and we do have a co-development agreement with them. Lantheus is also our largest shareholder, with about 12% of the company. For us, it is an important validation because a large company is taking an important stake in us because it's validating what we do, and also, we have a great collaboration. Actually, we are joint ventures with MD Anderson Cancer Center with the objective to develop new radiopharmaceuticals. The team is experienced. Everybody has previous experience from radiopharmaceutical, either imaging or therapies.
We recently had a capital raise, what we call a top-up capital raise, to help us to expand our runway into Q1 2027. This is our pipeline. I will focus, in the interest of time, on the top three molecules where we have clinical data, but first of all, I would like to take a quick overview of our five priorities. The most advanced technology, RAD101, is an imaging agent. It is for brain metastasis, so for secondary tumor in the brain. And this is important because it is a very large patient population. Coming from different primary tumors: lung, breast, melanoma. They all tend to recur or metastasize in the brain. So a very important agent to be used in addition to MRI, and I will cover in a moment.
We are in phase IIB, almost half of the trial, because we have those 12 patients out of 30 in total. We expect to complete this trial by Q1 2026. This is the only imaging that we are developing at this time. The other four molecules are therapeutics. RAD204 is our therapeutic targeting PD-L1, a very well-known mechanism of action, but we are the first and only company that has a PD-L1 radiopharmaceutical. We are in dose escalation stage. We have completed the first two dose levels at 30 and 60, and we are waiting the approval that should be coming very soon to go to dose level three. We expect to complete the dose escalation part of this trial by mid-2026. The third product is a therapeutic product targeting HER2. Again, very well-known mechanism of action where we saw great results from targeted therapy and ADCs.
We are the most advanced company that has a radiopharmaceutical targeting HER2. Also, this trial is in phase I, dose escalating, and we have completed the dose level one, and we are enrolling in dose level two. I will cover these three products in a moment. I'd like to give a quick mention of the two other therapeutic molecules that are going to be in clinical stage by the end of 2025. B7-H3 again is an emerging mechanism of action for multiple solid tumors. We know about ADCs that are in clinical development, and we know about radiopharmaceutical companies that are looking into it. We are the company that is most advanced with the B7-H3 radiopharmaceutical. In fact, we received IND approval at the end of July from FDA to start our phase I.
We expect to have the first patient dose during the month of November or December of this year. This product is coming from our JV with MD Anderson, as has been developed in their labs. And the last therapeutic agent that we are focusing on is in prostate cancer, but different from other companies that are looking mainly at PSMA as a mechanism of action. We are looking at KLK3, a very specific prostate cancer drug. We are using here a different isotope, Tb-161, to maximize the dual emission of this isotope. We expect for approval to start phase I again in November or December of this year. So five molecules that by December will be in the clinics. I will focus now on the top three. The imaging agent from brain metastasis is targeting fatty acid synthase as a mechanism of action.
Cancer cells in the brain are consuming more fatty acid than normal cells, so our imaging agent is able to capture the metabolic activity of the cancer cells, of course, without having uptake in the normal healthy cells. It is a large patient population, 300,000 new patients diagnosed every year with brain metastasis, and we are the first and only company that has an imaging in brain metastasis. We have performed phase I and phase IIA in London at the Imperial College London, where we licensed this molecule from. And now we are conducting the phase IIB here in the U.S. We have those 12 patients out of the 30 that are the total of the phase IIB, and after that, we believe that. A single registration or trial of approximately 150 patients will be needed to have approval and commercialization. This is the phase IIB.
It's important to mention the unmet medical need. MRI works extremely well to detect brain metastasis. It's a great standard of care. But there is a problem. The majority of these patients. Receive therapy. And the therapy is external beam radiation. Somebody is calling them gamma knife, CBR knife, so very precise radiation to the brain metastasis. After patients receive radiation. MRI doesn't work as well as before because MRI is not able to distinguish. Tumor from necrosis, necrosis that is created by external beam radiation. So physicians don't really know if what is left after the external beam. Is. Tumor or are healthy cells, are necrotic cells. So the objective of our trial is to show that using MRI in addition to our PET agent. Is better than MRI alone. This is an example of two patients of the current trial. So. This is patient number two.
You can see on the left MRI. This is the typical result of what a patient gets when he has this exam. You can see below the green cross that there is a black hole. This is a lesion, but what is not clear is if this lesion is tumor or it's just necrotic cell. So the guidelines are suggesting the physician. To send the patient home and come back after two or three months. They do another MRI, and they look if there is a change of the shape or the dimension of this lesion. If it becomes bigger, of course, it's tumor. If it stays the same, it's necrotic. But you know that two or three months can be a lot of time for a patient with this disease.
So what we did, at the same time as the patient is doing the MRI, we can perform a PET scan with RAD101. On the right side, you see the result. It looks very different. So there is a black hole at the center. This is likely to be necrotic tissue. But there is a white ring. Externally, and this white ring is likely to be the metabolic activity of cancer cells. If this is proven, the patient, instead of going home and coming back after three months, will likely go right away the next door to have another round of external beam radiation to try to cure or at least to limit the progression of these cancer cells. So it's a very different tool that can help a very different patient management. A second example for our study that we just released is this patient.
In this situation, you can see from MRI a white dot. This is likely to be a small tumor that is left post stereotactic radiosurgery. When we did the PET scan in the same patient, we see similar lesion, but with the PET, it's much larger. So likely, the tumor is not so small as you can see on MRI and needs to be treated in its entirety. So that's very promising results from our agent. We also asked an external company to do an assessment of the potential value of this imaging agent, and they came with an assessment, a commercial assessment that goes north of $500 million in yearly sales due to very large potential in this patient population. So we are very excited about RAD101. RAD204 is our first therapeutic molecule. It's targeting PD-L1 positive tumor.
So the patients that are entering the trial are patients that are refractory to checkpoint inhibitor. Either they do not respond right away or they progress after therapy. We are the only company that is targeting PD-L1 with a radiopharmaceutical product. We are using a single-domain monoclonal antibody or a nanobody with Lutetium 177. We are in dose escalating trial. We have the results from the first cohort at 30 mCi, the second cohort at 60 mCi, and we will soon go to the third cohort level. We expect to finish this trial by mid-2026. What are the current data available saying? First of all, the safety is absolutely favorable. At this level, we don't see any significant adverse event. And it is too early to speak about clinical activity, but we saw in two patients out of three that we had disease stabilization for some months.
This is an example of what you can see. The beautiful stuff that you can see from radiopharmaceutical is really that you can see where the product goes right away. After you dose a patient, you can check, and you can see under a SPECT camera where your product is localized. We can see good tumor uptake in the patient of the first cohort. This is the second patient, and this is the third patient. We have an average of 0.4 grays in the first cohort. That is an expected absorbed number. And two patients out of three stayed on therapy for 5.5 months. That is above the historical average for those patients that is about 3.5. We moved to the second cohort, and it's interesting to see in the second cohort a much higher tumor uptake.
So going from 30 mCi in cohort one to 60 mCi in cohort two, the tumor uptake increased by three times. So. Too soon to say, but we want to continue this trial because there are promising data showing that going up with the dose, you have a higher tumor uptake. And higher tumor uptake is correlated with clinical response. So. So far, very positive, and we want to continue. The third product, RAD202. Is a similar construct. It's a nanobody, again, with Lu-177 targeting HER2 expression. We see the logic of a radiopharmaceutical targeting HER2 to be used post trastuzumab ADC. It's a very large patient population, considering that now HER2 has expanded into HER2-low and HER2-low. So many, many patients will progress after this therapy. We have completed the first dose level at 30 mCi, and we are now recruiting the second dose level.
Again, the safety profile is extremely positive at this stage, and we saw significant tumor uptake also with this product, actually higher than what we saw before. You can see about three, 2.9, 1.2 grays in the tumor at only 30 mCi. It's a very important. And high dose. And with this, I pause here because I'd like to give some time for the Q&A. Again, for me, the key message that as a company, we are really looking into expanding the use of radiopharmaceutical in mechanism of action of tumor. We are currently, we can be first. In development or first. Or alone in development. So let me, so thank you for your time. And let me go to the. Q&A. So. I see a question. Congratulations on the recent, can you discuss. Condition? So the question is about why we raised money two weeks ago. Look, we.
When we raised money last time, it was in June 2024. We announced expectation to have a two-year cash bringing us to. June 2026. We were perfectly in line with the spending, but considering that now we are in October and we are only. Eight months of cash in the bank, we thought there was a good opportunity to raise money to expand just to avoid being too short. With cash available. So that was. The logic. We have another question that is about. What is the benefit of your partnership and joint venture with MD Anderson? So in our joint venture, we have four molecules that we are developing together. The first one is the one that I show. At the beginning. It's called RB01. Let me see here. RB01 is our B7-H3. It's coming from their labs and is soon to be in the clinic.
We also have three additional molecules still undisclosed. That we are developing. Of course, as you can imagine, for a small company like ours, to have the possibility to work with such a talented team at MD Anderson with all the tools, expertise that they have is a great advantage. Not only will we do preclinical work together, but for example, MD Anderson will be one of the centers for our RB01 trial that is starting soon. So we will have also the opportunity to have patient recruitment at their facility that, of course, is one of the most respected. So very important strategic collaboration. Same question, right? Can you discuss strategic partnership and now the idea is your pipeline development? Well, one is, I just mentioned the MD Anderson. The other strategic partner with Lantheus is important because they are our largest shareholder.
So for us, it's a kind of validation. They put money in the company three times. They invested in June 2024, in January 2025, and again in October 2025. So our reading is that they believe in what we do. They think that our molecule has high potential, and they want to be an important investor. Another question is, what are the expected timeline and current involvement for the Phase IIb of RAD101? What would you define a successful primary endpoint? So you can see here, RAD101, we have 12 patients announced two weeks ago out of 30. We think we can get to 20 patients by December. And full enrollment of 30 patients by Q1 2026. At that time, we will be able to communicate top-line results. For the full results, we need another six months because we have six months follow-up. So we'll be Q3 2026.
But in Q1 2026, we will already have a number of patients with follow-up and potentially all the trial recruiters. So we will be in the condition to start planning for an FDA meeting to discuss endpoints and statistical power of the phase three registration of study. We plan this meeting with FDA in June 2026. The primary endpoint is concordance with MRI. So you want to be sure that with our product, RAD101, you don't miss any lesion that you can see on MRI. But even more important, you want to be sure that you can see something different in addition to MRI. That will be a secondary endpoint, but will actually be the most important for us to decide as we think now to go to phase three.
So we are very positive at this time for RAD101 as it's progressing and the initial images and data that we saw. Let me see. There is a question about the volume of the trading on Nasdaq. The collaboration with Lantheus. It's a long question. I'm just reading and the capital raise. And why we lost probably some momentum in the share price at the moment. Well, look, it is normal. When you raise money and you raise with what we call a small discount, it's normal that there are a few weeks where the price stays there. I think getting the money was important. And my view that in a biotech story, what is important are the clinical data. And the clinical data are getting. To us on time and are all very interesting.
So yes, this might be a few weeks where the stock is upside trend and it went down. I'm very positive that we will start this trend very soon in a few weeks. What's the most important is that you see here in this chart, we have the first three trials that are readout in 2026. RAD101 at the beginning. RAD204 mid-year, RAD202 at the end of the year. The three molecules readout. Their clinical trial, I think this is a number of very important milestones that we have ahead of us. So I'm very, very positive about what we are doing. Of course, nobody can guarantee any results because that's the beauty and the difficulty of science. But so far, the early signals are all extremely positive. So I continue to be extremely confident, and the money is important to continue this highly differentiated pipeline.
Let me go back to see if there is long talk, if there is any other question. Can you quantify the total addressable market for RAD101? Well, I think I showed a slide. Let me go here. I can show again. This is an external research considering that there is no competition expected for a brain metastasis imaging. There are products in glioma, but not in brain metastasis. From this assessment, we see that the market share is expected to be 94%. That means it's almost the entire total addressable market is around $500 million. I consider this forecast a little bit conservative because you can see at the left that the number of scans per patient is 1.1. I expect this to be closer to two because it's logical to think that a patient will do a baseline and then another follow-up scan and not only one.
So I think it's a very interesting total addressable market, probably between $500-$700 million per clinic, and this is U.S. only. So this is excluding Europe, Asia, Australia, Japan. That's U.S. only. There's a question about October capital raise and the cash runway. I think I added in the first slide, our cash runway is into Q1 2027. I think I've answered all the questions. So thanks a lot for listening. Thanks a lot for engaging with the question. Feel free to reach me at any time. You can find in our website all our contacts. My email is there or you contact directly from the website. I'm very happy to take any further questions. And thanks for having me.