Good morning, good afternoon, or good evening. Welcome to the 89th Emerging Growth Conference and day one of our two-day virtual investor conference. I'm Ana Berry. A few notes: today we're running until 4:50 P.M. Eastern, and when we switch to the next company, you'll see a black screen for a moment. If you do experience downtime for a minute or so, just refresh your browser and everything will work properly again. Our platform does work best on Google Chrome, so if you're watching from an Apple device, you have to hit the play button to start the session. Now, during each company's presentation, you can submit questions through the webcast module, and we will attempt to address as many of these at the end of the presentation, and all of our conferences, they're uploaded to our Emerging Growth Conference YouTube channel, so please subscribe, youtube.com/emerginggrowthconference. Let's begin.
Today we start with Radiopharm Theranostics. They trade on the NASDAQ. Excuse me. Let's begin again. We start with Radiopharm Theranostics, trades on the NASDAQ under the symbol RADX and on the ASX under the symbol RAD. It's a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical needs. Happy to welcome Managing Director, CEO, and Director. We have Riccardo Canevari. Welcome to the conference today, Riccardo. Happy to have you.
Thank you, Ana. Thank you for the introduction. Very happy to be here. Thank you for listening. As Ana was saying, we are a company with a core business in radiopharmaceuticals. We are in clinical stage, and we like to advance first-in-class radiopharmaceuticals. That's really our focus. We focus on highly differentiated molecules. Also, we built during these four years (the company was created at the end of 2021), two strategic partnerships. One is with a very strong leader and player in the radiopharmaceutical space that is Lantheus. They are our largest shareholder with about 15%. And we have a scientific partnership with a very well-known institution like MD Anderson Cancer Center. If you look at our pipeline, we are very proud to be now in clinical stage with all our five molecules.
For interest of time, today I will focus on the top four, so we have enough time also for Q&A at the end. The most advanced technologies and imaging agent is an area of high unmet medical need that is brain metastasis, and is currently in phase II. We are more than 50% of trial recruitment. And then we have four therapeutics molecules. The PD-L1 Nanobody is in phase I at the third dose level, so the dose escalation of the phase I is continuing successfully. The second product is also a Nanobody targeting HER2. Again, it's a basket trial in breast cancer and gastroesophageal cancer. We are in phase I at dose level II, so also dose escalation. And now we are starting the additional two trials that have been approved, and we are ready to dose our first patient.
The first is RV01, a monoclonal antibody targeting B7-H3 with Lutetium-177. This molecule is coming from our partnership with MD Anderson. The last, the fifth molecule that is part of our top priorities, is a monoclonal antibody targeting KLK3 expression, a very well-known pathway in prostate cancer. It is radiolabeled with a very innovative isotope that is Terbium-161. We plan to dose the first patient during the month of February of this year. Let me go quickly one by one to give you a little bit more information. Our most advanced technology is in phase II. We are in a very positive competitive position. We currently do not have any other radiopharmaceutical that is in development, so we do have a significant advantage in the market. Brain metastasis is a very large patient population.
It's about 300,000 new patients every year only in the U.S. So this is a secondary tumor for a patient that has a primary tumor in other organs, and unfortunately, it progresses in the brain. And so for those patients, there is an important unmet medical need because MRI works very well for detection, but does not work so well after the standard of care therapy that is called stereotactic radiosurgery. So we are above, beyond the 50% recruitment in our phase II. And after conclusion of the trial, probably around March, April of this year, we plan to go to phase III registration of the trial. But this is what we are doing in our phase II, so patients receive one dose of RAD101 PET imaging, and we compare it with MRI that is the standard of care.
Last month, we released positive interim data in 12 patients out of the 30 patients of the trial, and 92% of those patients, so 11 out of 12, achieved the primary endpoint, that is, concordance with MRI, so very positive interim analysis is giving us a lot of confidence about the final results. I put three examples here where we compare MRI on the left and our PET molecule on the right. The first objective is to be sure that we don't miss lesions. So what we see on MRI on the left, that is a lesion, potentially tumor or necrosis. We see also on the right with our PET agent, and similar for another patient, this is a similar example, so our products really can confirm what is available to see with MRI.
But why it is potentially interesting is also because our products can see something that MRI is not detecting at the right time. So we see an example here on a patient where on the left receives MRI, and the MRI is not showing anything. But our RAD101 PET, you can see on the left a lesion, a white bubble, and this is likely to be a tumor. So what the physician does in this situation, they continue to do MRI in the patient. And we see after month number two and month number four that you can see first a small dot and then a larger dot emerging. So this is confirming in this patient that RAD101 has the potential to detect the presence of a tumor or likely to be a tumor at least four months in advance to MRI, and time is critical here.
So very exciting data that we want to prove in a larger patient population in a bigger trial. So that's why we plan to complete the phase IIb and then discuss with FDA the design of the phase III. Now I move to the therapeutics. This is a PD-L1 targeting molecule, so looking at multiple solid tumors, like for example, non-small cell lung cancer. We use Nanobodies, so these are small molecules that are radiolabeled with Lutetium-177. And we are the first-in-class company. We are the company that has the first-in-class products in this indication. Again, we don't have direct competition here. So we are conducting this trial with the typical dose escalation. We have already dosed patients at dose level I, 30 mCi, dose level II, 60 mCi, and now we are dosing at 90 mCi. What are the early results?
In the first two quarters, we see a very positive tumor uptake. We don't see side effects, and for this reason, we continue the dose escalation, adding more Lutetium because we want to see clinical activity, so the trial is progressing well, and we continue to monitor, of course, the results. Our second therapeutic molecule is also a Nanobody, is targeting HER2 in breast and gastroesophageal cancer. Same structure, so it's a small molecule with Lutetium-177 as an isotope. Where we are here, we have dosed the first cohort at 30 mCi, and now we are dosing the second cohort. We reported some early data in three patients, and in these three patients, we saw significant tumor uptake. The safety profile is very favorable with no adverse event, so we are increasing the dose, and we are now dosing at 75 mCi, and we will continue going up.
The objective of this trial is really to continue to go up and hopefully show clinical initial signs of clinical efficacy with limited side effects. For the time being, we are on track with our expectation, and we continue to be extremely positive and hopeful that this trial can bring to something important that is not available today. A quick overview of our third therapeutic molecule. This is a monoclonal antibody. It is coming from research and development at MD Anderson Cancer Center in Houston. B7-H3 is an important new pathway in oncology. We are very interested to see the potential results. The molecule has a very interesting profile, has been modified in the Fc region in order to create a monoclonal antibody that has a better profile.
So the two modifications in the Fc region have the potential to reduce the presence in the blood in circulation of the monoclonal antibody and reduce the risk of bone marrow toxicity. At the same time, the molecule has a very strong affinity for the B7-H3 target that is key because this is where tumor is expressed. We have encouraging preclinical data with 56% survival after a single injection in the animal model. So these are the needed data that allow us to discuss with FDA and to have IND approval. So we are now at a step where we have two centers already open. We plan to have six centers in the U.S. to recruit at this trial. And we can enroll or dose the first patient now any day, hopefully in the next couple of weeks because the trial is now officially open. B7-H3 is an interesting area.
There are other radiopharmaceutical companies, in particular two of them that would like to develop a radiopharmaceutical in this area. One company is called Aktis Oncology, and the second company is a big pharma, Novartis. Both have a B7-H3 molecule. What is positive from us is that from a competitive situation, we are six, nine, or 12 months ahead of them. It's difficult to be more precise, but we have made steps like IND approval and readiness for patient screening that put us in a situation of advantage. So of course, we are fully focused to continue to keep our leading position in the space. And with this, I can conclude my overview. So hopefully, I can leave more time for Q&A. So back to you, Ana.
Okay, perfect. Thank you. Yeah, we have a question about what are the most important upcoming clinical milestones?
Talk about the next 12 to 18 months, and do you have an estimated delivery of the results of phase II and III?
Yes. So depending if you're looking at imaging or therapeutic, we think that in 2026, all these trials will deliver clinical milestones. So 2026 is going to be a very critical year for us, and we are very excited. Now, the most advanced technology is the imaging agent in phase IIb. So we think that we can complete the enrollment around March or April this year, and we can report the clinical data of the phase II before June. So that's the most important milestone for our imaging agent, so it's the full data release of the phase II. For the therapeutic, of course, with the dose escalation, we continue to go up, and it's important to see clinical activity. So we believe that, again, mid-year, mid-2026, we will have significant clinical and human data with the two trials, RAD204 and RAD102, to be completed in 2026.
So again, a lot is happening in the next three, six, and nine months.
Exciting times. A question about the RAD101 and 102, 204, and 301. So how do early clinical results across those trials compare to competitor radiopharmaceuticals?
Yes, thank you. Very good question. As I mentioned at the beginning, we try to select molecules and targets where we have the opportunity to be first in class in development. So for RAD101, at this time, based on public information, there is no other radiopharmaceutical company that is doing an imaging trial in brain metastasis with another molecule. So not only are we ahead, for the time being, we are the only one. For PD-L1 and HER2, for PD-L1, again, we are the first in class, so no competition as a PD-L1 radiopharmaceutical. And for HER2, there are two other companies that are developing a HER2 radiopharmaceutical. Both of them are in preclinical stage while we are in clinical stage. So we are well positioned in time to be first in class, first in clinical development.
Of course, we need to keep working hard on execution to be sure that we remain ahead.
Perfect. And a viewer was reading some past press releases, and he wants to know how predictable are manufacturing and isotope supply chains, and can the company scale supply reliably?
That's a very important element in radiopharmaceuticals. You need to have enough supply of isotope because isotopes, from a physical point of view, they decay. You cannot just keep them in a warehouse. You need to use them right on time. So during the first four years when the company was created, we really worked with a number of external partners to secure the supply chain. For example, for our Lutetium-177 isotope that we are using in three trials, we have multiple suppliers. We have a supplier in Australia. We have a supplier in Europe. We have a supplier in the U.S. So we believe that we have a redundant and secure supply chain that can allow us to go to phase III and commercial.
Perfect. And what's the anticipated burn rate by program, manufacturing trials, R&D?
Yes. So the company is lean. We are only 14 employees. So we try to keep the cost quite low. But of course, the clinical trials are the main investment that we are doing. We usually spend about $6 million-$7 million per quarter. We probably go up a little bit because now we have two additional trials coming. But all included, we know that we have enough cash to get to the beginning of Q1 2027. So we still, let's say, have 12 months of cash, assuming that we do all the five trials that we mentioned before. So we are in a good position to have 2026 as an important year where we can deliver clinical data that can support the future need of financing.
Perfect. Is there meaningful revenue or near-term commercialization potential?
The products that are closer to revenue generation are RAD101, which is the imaging in phase I. We are only one trial away, if you like, is the phase III before we can launch the products in the market. I think we are talking probably end of 2028 to complete the phase III, and so 2029 can be the year where we start selling the product, assuming we don't find earlier a partner to work with that can potentially help us with some upfront or milestone or profit-sharing agreement or any type of agreement that can support us, the phase III and commercialization.
How strategic is Lantheus's investment and partnership in the company's long-term financing story?
Yes, it's very important. Lantheus is a leader in the space. They know extremely well the radiopharmaceutical areas. They are our largest investor with 15% of the company. They don't have a board seat. They don't have any first right of refusal. So they play the investor roles. But of course, they are a $5 billion market cap company. So they are looking at our products, and I'm sure they are interested in many of them. So our job is really to advance, to prove that these products can be successful, and potentially that collaboration can go to the next level.
Talk about how Radiopharm's pipeline compares to established players in theranostics like Novartis, Telix, and POINT Biopharma.
Yes. So Novartis, of course, as a big pharma, has been the leader in the space. They have products in commercial stage like Pluvicto for prostate cancer, and they have a very large pipeline. So I think it's realistic to think that Novartis is set to be the leader in the space for a number of years. Telix is more focusing on imaging molecules. They have some therapeutic in development, but their initial focus is imaging. So I think we are in a different proposition, business proposition here. We are more towards therapeutics. That's what you see in our pipeline. So we're likely to be a more therapeutic-oriented company than Telix. POINT Biopharma has been acquired by Eli Lilly now. So their molecule went into the big pharma, Eli Lilly. So it's more difficult to see what is happening in terms of development.
They had maybe two molecules in development in later stage. None of these molecules are in the mechanism of action that we do have. So the molecules were in prostate and neuroendocrine tumors. So they don't really compete with what we do. I think we create a very nice area where we offer highly differentiated products with very limited competition at this stage.
Perfect, and talk about the strategy for partnering or competing on commercialization versus licensing.
Yes. So we always need to consider how big we are and our size and to be sure that there is the right level of ambition. We don't think at this time that building a commercial organization in the near term can be the right strategy for us. I think our value creation is really to bring the products to the end of phase II and to show high potential value. And at the time, we are very open to partnership because the trial becomes longer and more expensive. So we see ourselves as a clinical development company, very open to partnership or licensing out when the value creation, of course, goes significantly higher than it is today.
Perfect. And Riccardo, do you have any closing remarks for our investors watching today?
Well, first of all, thank you for your time. It's been great to be here. My final remark is we really used the first four years of the company to create a clinical stage organization. Having five molecules in clinical stage delivering clinical data in 2026 is really exciting. We believe it can be a pivotal year for us. And so the team is really focused on execution. We believe there is such a medical need. Cancer patients are always waiting for better solutions. And we want to do our best to prove that we can contribute.
Wonderful. Well, thank you so much for joining us on the conference. Powerful work you're doing. And we certainly look forward to following along your journey into 2026.
Thank you, Ana.