Welcome to the 30th Deutsche Bank Depositary Receipts Virtual Investor Conference, DBVIC. My name is Zafar Aziz from the DR Investor Relations Advisory Team at Deutsche Bank. I'm pleased to announce that our next presentation will be from Radiopharm Theranostics. Before handing over to our presenter, some points to note. Please submit your questions at any time throughout the presentation. Finally, all of today's presentations will be recorded and can be accessed via the Deutsche Bank website, adr.db.com. At this point, I'm very pleased to welcome our speaker from Radiopharm Theranostics.
Thank you very much for having me. Thank you to the Deutsche Bank team, and thank you everybody for listening. My name is Riccardo Canevari. I'm the CEO of the company. Radiopharm Theranostics is a multi-asset, first-in-class radiopharmaceutical platform. What we do, we take molecule, we attach isotope in a very targeted therapy approach. This is the disclaimer. What is different about our company? First of all, differentiation. We are building one of the most differentiated pipeline in the radiopharmaceutical space. We are focusing on four clinical stage radiotherapeutics across different targets, PD-L1, HER2, B7-H3, and KLK3 in prostate cancer. The way we deliver the isotope is through protein engineer molecules. That's really our expertise. We use clinically proven beta emitter like Lutetium-177 or Terbium-161. We are a small company.
We are not vertically integrated. On the opposite, we have, I believe, a very capital efficient business model with distributed development with important partners. Our pipeline is deep, so we believe we have multiple shots on goal. Let me have a couple of slides about the space. The radiopharm segment is entering its second wave. There has been validation, mainly from the leader, Novartis, with Lutathera and Pluvicto, that are having a significant success. In the next wave, there is interest to go beyond the two mechanism of action of these two products, so beyond SSTR2 and PSMA in prostate. That's what we are trying to give our contribution to our protein engineer radiotherapeutics. In addition to that, still looking at the sector, we saw different waves of consolidation or M&A.
The first wave was really about buying the infrastructure. The target companies were mainly vertically integrated companies, and you can see some examples in the slide. The second wave that is happening now is more pipeline expansion. The companies, the big pharma, are looking to expand their radiopharmaceutical pipeline by looking at companies that can offer differentiated molecules. This is really our role. That's what we are building, a highly differentiated group of molecules. We are a pipeline company. I mentioned before our core business is really about working with vectors, with proteins, and engineer them to deliver optimal biodistribution. We are working with two different platforms. One platform is the nanobody; they are small size, about 15 kilodalton. We have two of them in the clinics.
They have several advantages like the tumor penetration or the reduced background exposure. The second platform are the monoclonal antibodies. Here we use both traditional humanized IgG1, as well as modified monoclonal antibody in the Fc region to improve human biodistribution. This is really the core of our business in terms of bringing innovation to the sector. From a pipeline point of view, our top four core assets are here in the slide. Four molecules in phase I. The first two molecules, the PD-L1 targeting radiopharmaceutical is our lead program, is like middle of phase I will show in a moment. What is unique that this is a first-in-class radiotherapy. We are the only company that has a radiopharmaceutical targeting PD-L1.
The second program is a nanobody targeting HER2, a very well-known mechanism of action in oncology that is present in a larger number of patient population, mainly breast and gastroesophageal cancer. Also, this program is mid of phase I. We have two programs, the two monoclonal antibodies that are more at the beginning of phase I. We just dose two patients each, targeting KLK3 in prostate cancer and B7-H3 in a number of different solid tumors. Four programs in phase I. Let's go one by one. PD-L1 targeting radiopharmaceutical, of course, is a validated immune oncology target. Our company has the first and only PD-L1 radiopharmaceutical in clinical development, and we believe the value o f this molecule is post-IO in non-small cell lung cancer mainly or in other solid tumor.
We know PD-L1 well, of course, from the success of the checkpoint inhibitor, but also we see emerging ADC going after this target. What is unique about us is using radiotherapy or radiopharmaceutical. We know the success rate or the benchmark bar is not so high post-IO. There is a important unmet medical need to go and to be rewarded if you have a successful product. We have completed in our dose escalating trial the first two cores. We saw important tumor uptake as well as favorable safety, now we are dosing the third dose level at 90 millicurie of lutetium. We knew that the first two dose level were likely to be subtherapeutic. That's normal in a dose escalating trial.
Now dose level three is becoming interesting, is when you can expect that there is a biological effect from having the products injected. Very exciting time in the next six months to see the potential results at this level of dose in the patient that we are treating in this phase I. If we continue, the second target is HER2, again, very well-known target, successfully covered by monoclonal antibodies or ADC like Enhertu. Still there is a very large unmet medical need post-ADC. Our products again is a nanobody targeting HER2. We are also targeting a different epitope versus trastuzumab. We are conducting the phase I trial, successfully done the first two cores, again, favorable safety profile, tumor uptake.
Now we are dosing dose level 3. 130 millicurie start to become an interesting dose again, if you consider that the products approved by FDA are dosed at 200 mCi, and we are at 130 mCi, we start to be close to the potentially right dose for the patient. Again, excited about the next six months for this trial. Also, you know, there has been a lot of learnings during the trial, so we introduced a new next generation formulation in dose level three. This is really, you know, as I mentioned before, the core business of what we do really to understand how to engineer proteins.
In this specific case, we wanted to improve the tumor-to-kidney ratio, and we were able to do it by a small modification in the molecule. We didn't want to touch the binding region because affinity is great and tumor uptake was strong, but we want to avoid that there was too much kidney retention. We eliminate a tail, if I can call it this way, a His-tag tail, and we saw in the preclinical model that this is reducing kidney uptake by around 50%. Now we introduce this new formulation in the dose level three. We're really looking forward to see the positive impact of the new formulation at this level. Our third program is in prostate cancer, but it's a different approach for the more traditional PSMA.
We are looking at a new mechanism of action called KLK3, highly specific for prostate. We are conducting the phase I. Here is a monoclonal antibody, is a humanized IgG1, very selective in the picomolar activity for KLK3, and we are using terbium-161 as an isotope. We like terbium for its dual emission, both beta and Auger, and we think can be extremely potent and well-tolerated at the same time. KLK3 is a very interesting target. You can see here a comparison with the more traditional PSMA that is the target of Pluvicto from Novartis, and you can see how clean the target is. This means that likely we will find or see less off-target toxicity because KLK3 is really expressed only in the tumor. That's an important element for radiopharmaceutical therapies.
We just started phase I. We have dosed a couple of patients, so we are still a low dose. The trial is progressing extremely well, and of course, we are very interested to see some potential results very soon. Overall, the combination of KLK3 as a new target in prostate cancer and Terbium-161 as an isotope has the potential to be extremely effective in such a large market. Again, exciting trial that is ongoing. I'd like to close the therapeutic session before going quickly to imaging with our four products. B7-H3 is one of the most interesting target at this moment. For those that has been at AACR recently, you might have seen a significant number of targeted therapy or ADC going after B7-H3.
Now our approach is again to go to this target with the radiopharmaceutical technology. In this case, we are using a monoclonal antibody, but the monoclonal antibody has been modified twice in the Fc region, in the FcRn and Fc-gamma receptor, in order to improve human biodistribution. We are at the beginning, but we have already dosed a couple of patients here, we are phase I, dose level one. The trial is currently recruiting in the U.S., actually started with recruitment rate very, very strong. Excited about this opportunity as well. The four therapeutics products are really our core business, but we have developed imaging compounds as well. In particular, one of those is very intriguing.
The imaging portfolio for us is a standalone opportunity for commercialization, for partnering, from giving us strategic optionality. We don't want to mix with the therapeutic. We want this to be value creation, we are very active in discussing all the strategic opportunities. We know there is value created, in particular for our RAD 101, is an imaging agent for patients with brain metastases. There is a very strong unmet medical need in the area. We have completed not only the phase I here, but also the phase II. Fully recruited, 30 patients out of 30. We have disclosed the interim results, we are planning for the data readout of the entire trial June of this year. Here is what I mentioned.
There is a significant need for patient with brain metastases after stereotactic radiosurgery, where MRI is not performing well, is just not able to distinguish tumor from necrosis coming from post-SRS. There is a need of an additional technology that can help physician to detect better or earlier if there is tumor progression in the brain. This is the hypothesis behind this molecule. We have performed the phase II, and we have released about a month ago the interim data in 2/3 of the trial, so 20 patient. We saw in 18 patient out of 20 concordance with MRI. That is very important because all the patient coming in the trial has a questionable result from MRI. The fact that MRI was confirmed, if it was tumor or necrosis, is of significant help for the physician.
We need to release the full data in June, but at this time, we are confident that we can support to proceed to discuss with FDA what is going to be the phase III design and implementation, so likely to be one trial away from commercialization. Overall, I'd like to conclude here and open to Q&A. Radiopharm Theranostics is a very important moment. We have in the three , six, and nine months multiple catalyst with our differentiated platform. We have four clinical programs progressing in parallel, all of them can deliver value. We have near-term readouts from the pipeline. The imaging is an add-on opportunity for value creation and potential partnership.
Overall, we think that there is an asymmetric opportunity with multiple shots on goal, and we are very excited about what we can achieve in the next few months with the trial running in parallel, dosing patient, and having data available, you know, every week now going forward. With this, I really like to thank you for listening, and I am going to look at the Q&A that I see on the screen. Give me a second. I just switch view. The first question is about RAD 101, the imaging agent that I just discussed.
The question is, saying, "Assuming RAD 101 development continues on its successful course, what is the plan for commercialization?" Yes, as I mentioned before, we think that as a company, we can contribute to the phase III. Likely we would prefer to have a partner to conduct the phase III. Definitely we want to look for a commercial partner for commercialization. It is not our role to build a commercial structural field force. We want to focus on developing our four therapeutics molecule. We will actively look for a commercial partner. The second question, the company presented RAD202's first in human data at a major oncology conference. Has that visibility led to more inbound interest from big pharma or specialist radiopharma players on potential collaboration?
To be fair, the presentation was only a week ago, so we didn't receive, like, tons of calls in a week of time. On a broader note, I think it's important to say that the number of public radiopharma company is quite limited. We are very visible to big pharma, and we have continuous conversation about their potential interest. At this stage, what is critical for us is to deliver initial data on not only on safety and tumor uptake, but on clinical results, and this is probably the significant game changer for us that will make our pipeline of a big interest to other larger company. Another question, cash remains healthy, and there is clear runway remaining, but with five key projects running simultaneously, how is capital being allocated?
Yeah, very good question. The phase II trial is finished, the imaging. We are allocating capital to the four therapeutic trial. Three of them are running in Australia, and one trial is running in U.S. Why I mention this? Because by running the trial in Australia, we benefit for 42% of the cost in terms of cash back from the Australian authorities. Running a trial in Australia, it costs almost half that running in U.S. For this reason, we are capital efficient from a trial allocation, and we are capital efficient as a company. We are only 17 employees, and we have five clinical trials. I think is a great ratio. We work with consultants, we work with third-party on a project basis, and this is allowing us to be extremely capital efficient.
I am confident that we can continue to deliver and execute very well those trial with the current resources in term of team and money. Let me see. I think there is another two question. One question is, "If the primary endpoint of RAD 101 is positive in June, could RAD 101 become your first commercial products and a near-term revenue driver?" The answer is yes, we still need to do the phase III. We need to discuss the phase III with the FDA. The size, 150 to 100 patient. We don't know yet. We need to align on the endpoint that are pretty clear. They are likely to be sensitivity and specificity.
We would be one trial away to commercialization, that would be a potential revenue generating asset in the not too distant future. I think I have still oh, two. Okay. One question is, "What are you hearing from key opinion leader in the neuro-oncology about RAD 101?" Absolutely. Look, not only we are hearing, but we want to hear more, we have an advisory board scheduled for the fifth of May. Before the ad board, of course, we speak with all the principal investigator and with key opinion leader. The message is very clear. The story or the narrative of RAD 101 makes a lot of sense. MRI has limited efficacy in patient post SRS. There is a need for a PET agent to confirm MRI or to do better than MRI.
All the trialists, all the principal investigator, and now we will listen at the advisory board, seems to be extremely excited about the need of having RAD 101 available to the patient with brain metastasis. Another question of RAD 101 is, "The company has now completed the phase II-B trial. What are the data points you'll be watching beyond the primary concordance?" Yes, very good question. The trial has two endpoints. The primary endpoint is concordance. It is what will be available in June. The second endpoint is long-term follow-up of six months with multiple MRI control. The secondary part, endpoint is not necessary for the phase III, but it will be informative.
We will look, despite not statistically significant, at the initial results of sensitivity and specificity that will come from the secondary endpoint. I have now a question about HER2, our RAD202 program. How important is the HER2 low and very low segment for RAD202? Could that group actually be the biggest upside? A lot of learnings from the ADC space and Enhertu, we know that Enhertu is successfully effective in not only in patient with HER2 high, but also where HER2 low and ultra low. This is making the HER2 segment two, three times bigger than what it was before Enhertu five or seven years ago. Our positioning is post Enhertu. If Enhertu, as it is moving to first line metastatic, the post Enhertu space is going to be significantly big and bigger.
The answer is yes, we are treating patient that has HER2 high, HER2 low, and HER2 ultra low, and this segment is significantly large to have an important impact for the products itself and of course for the patient that can benefit. Just see another question coming. Radiopharm just dosed the first patient with RAD 402 in prostate cancer. What are the main early signal you are watching to confirm that this can beat PSMA-based approaches? We are running the trial in Australia. Why this is important? Because in Australia, there is limited availability of Pluvicto or lutetium PSMA agent due to reimbursement challenges. We are in a very good position that we can dose patient that are Radiopharm-naive, so Pluvicto-naive. We can really compare the data with the data that brought Pluvicto to reimbursement, approval and reimbursement.
What are we looking? One of the KPIs that you can look quite early in prostate cancer is PSA reduction. This is faster than PFS, and this is in addition to radiographic PFS or, you know. You don't always have tumor shrinkage in prostate cancer, and particularly if you have bone metastasis, it's very difficult to assess. The PSA reduction is an understood, a well-known efficacy surrogate endpoint that is very important. We will look at that one as a first objective, and we will compare to what Pluvicto achieved in a similar stage trial, phase I and phase II. We will have a very clear benchmark. I think I have another question. Might be the last one if we want to stay in the 30 minutes allocated.
A recent independent article frame Radiopharm as having several 2026 milestone that could unlock value. Which of the milestone do you personally think the market is assigning the least credit for today? Look, we need to be fair. The program are exciting, highly differentiated, but we are at the beginning or mid of phase I, where you can prove safety, you can prove tumor uptake. Nowadays, for any modality, everybody wants to see already in phase I early sign of clinical efficacy. For me, this is the key focus. I mean, can we in the next three to six to nine months to show that we have one patient as a partial responder, two patient as a partial responder?
Do we have early clinical activity that show that, you know, we have a biological, effective way to, to manage cancer types? For me, the two nanobody, RAD204 and RAD202, are the one with the highest dose, in the possibility to show soon some activity, and then the two other trial. As I mentioned before, I like to close now as we don't have additional time, saying I'm very excited about all the four products. They are running in parallel, each of them will deliver important information to us, and we will release to the market, because these are open label trial, in the, in the near future.
2026 is going to be a critical year, and, I'm very excited to lead my team at this moment and hopefully to bring our contribution to patient that are living with cancer disease. Thank you very much for listening and being at the webinar.