By popular demand, has been around some of the best investing conferences in Australia across various sectors. Again, encourage everyone to check out those. Without further ado, the first presenter today, we have Radiopharm Theranostics, and the CEO, Riccardo Canevari. Radiopharm is a clinical-stage radiopharmaceutical company advancing a portfolio of targeted oncology therapies with multiple programs already in human trials across solid tumors. Riccardo and the team just had an important update on that yesterday, which I'm sure he will talk to. Riccardo, over to you.
Thanks a lot, Matt. Thanks for having me, and thank you everybody for being here. Yes, Radiopharm Theranostics, as you might have seen yesterday, we had an important announcement about our leading program, so RAD101. As you can see, our pipeline is in phase II-B, at the end of phase II-B now. Yesterday we reported the second interim analysis. We have the first interim analysis of 12 patients in December, and now we have the second interim analysis with 20 patients out of a total of 30. Data from the two-thirds of the trial. I'm very pleased to share that the second interim analysis really shows very positive data. We saw. I can go to the slide immediately.
We saw 18 out of 20 patients with positive results with our drug. This is a trial for brain metastasis. These are patients that has a primary tumor in other parts of the bodies. The tumor goes to the brain, and when it is in the brain, the patient wants to be properly diagnosed. The recruitment criteria for the trial is that these are all patients where MRI doesn't work well. The physician decided to use the trial because they didn't have enough information from MRI. They didn't know if after the treatment, the patients still have tumor or not. Of course, it's such an important information to have.
Now, by using RAD101 in 18 out of 20 patients, so in 90% of the patients, it was possible to have better information so that physician can decide what was the best for the patient, another treatment or doing nothing. Very, very encouraging results. Another positive element that we didn't release yesterday, but I can share today that we have already recruited 27 patients out of a total of 30. We have two patients already with an appointment set up. We are perfectly on track with this trial. We think that we can complete recruitment in two to three weeks during the month of April, and we can report the final data around May, June. The trial, I go back here, the trial will be completed and reported the primary objective around May, June of this year.
Now, thanks to the interim results that are so positive, at this stage, we are very confident to go to phase III. We are planning a meeting with FDA around June. The meeting is not to decide to do a phase III or not. The meeting is to discuss how the trial design should be and how many patients should be in the trial. Very exciting time. This is a very big medical need. It's a very large patient population with 300,000 new patients only in U.S. We couldn't, you know, aim for better results than what we have seen in the second interim analysis. We are very excited for RAD101 as our lead technology. This will allow us to go to registrational trial.
We have the ambition to have the approval to start the phase III this year by the end of 2026. To start our pivotal registrational trial. Very good news, very positive, results. I also want to go briefly to the rest of the pipeline. We have four therapeutic products. All of them are in the clinics. Three of them, by the way, are studied in Australia. RAD204 is a phase I trial in patients that are PD-L1 positive. It is done with a nanobody and with Lutetium-177. How the trial is progressing? Well, I would say very well. We already have data from patient at two initial cohort dose level, so 30 millicurie and 60 millicurie. Now we are dosing at 90 millicurie. The trial is progressing well. We are continuing the dose escalating.
That means that until now, we have not seen negative side effect. We continue to increase the dose with the objective of having tumor efficacy. This is exactly what we were expecting, and we are pleased to see that the trial is progressing well. The idea from these two cohort, as I say, results are very promising, safety profile is clear, and we are recruiting now the third cohort. We think we will have the final phase I data by end of 2026. The second product, RAD 202, is for patient with breast or gastric cancer, HER2 expressing tumor. Also, this trial is progressing well, is with a nanobody with lutetium-177. The trial is ongoing in Australia. We have completed the 30 millicurie dose level.
We are now recruiting the 75 millicurie, and I can say that we are almost done. Very soon, we will be able to go to dose level 3. Again, it means the product is safe. We see very positive tumor uptake, no side effects that are significant, and for this reason, we can continue to increase the dose to allow the patient potentially to have early sign of efficacy. Very positive, you know, execution of this trial, as well, as I said, recruiting that 75 millicurie dose. These are the two nanobodies, two trials in phase I. Now, about two weeks ago, we announced the first patient dose with our third trial. This is ongoing in U.S. It's a molecule targeting B7H3. That is a very important target in oncology that is expressed across multiple different solid tumors.
The product is called BetaBart. It's coming from the research of MD Anderson, where we in-license with an exclusive deal this product. It's a monoclonal antibody. It's specifically targeting the 4Ig isoform of B7-H3, and we are using lutetium-177. Very strong preclinical data, and now we were pleased that on February twenty-third, we dosed our first patient. Also this trial is officially started. It's looking at patients with different tumor types, prostate, lung, colorectal, breast cancer, head and neck, ovarian, endometrial, all areas where, of course, there is an important need. The idea is to dose at 35 millicurie of lutetium to do three patients, and then as we expect, probably no side effects, so we will be able to go higher. That's the third trial that just started.
We are in a great competitive position because B7H3 is a very interesting target. There are other companies, in particular two radiopharmaceutical, like Aktis and Novartis, that are having a similar molecule. We do have the advantage to be the first in clinical development, so we probably have 6 to 9, 10 months advantage compared to competition, so we would like to keep, of course, this edge. I like to mention our fourth therapeutic product. This trial is ongoing in Australia. We are recruiting patient with prostate cancer. Now, what is important that many companies are in prostate cancer targeting PSMA as a mechanism of action.
We are the first company that is targeting a different mode of action that is called KLK3, and we are using an isotope called Terbium-161 that is also extremely innovative and very powerful. It's a monoclonal antibody. We are now screening patients. We know that in particular in Australia, there is a very important need due to the lack of the reimbursement of standard of care Pluvicto. We already in fact receive significant number of requests from patients that want to be part of this trial. The screening is going extremely well, and we think that we can dose the first patient very soon. Why it is important to target KLK3 instead of PSMA? That is where other companies are going.
As you can see, PSMA is expressed not only in the tumor, but also in healthy tissues, while KLK3 is expressed only in prostate cancer. We do believe that by targeting KLK3, you are going to deliver the therapeutic dose only to the tumor and not to the healthy tissue. That's why we think it's a very differentiated proposal, and we are very positive about the potential outcome. As I said, the first dose level is starting now with the first patient that we plan to announce very soon, in combination with Terbium-161. Overall, this is, you know, the fourth of the therapeutic products. I like to close with a quick overview of the pipeline. For a company like ours, we really want to focus on area where other company are not present and where we can be first in clinical development.
If you start from the top, RAD 101, we are the first in class. RAD 204, we are the only company with a PD-L1 radiopharmaceutical. For HER2 and B7H3, we are the first in clinical development, as well for the KLK3. So we are really trying to bring a lot of innovation in the space. It's very important all the work done in the previous, you know, three, four years in the company has been about bringing the molecule to be able to be in clinical study. Now having five molecule all in clinical stage will allow us to have, in the next two, three, six months, a lot of clinical updates. All this trial will generate interim data or final data.
In particular, if we look at the two nanobodies, RAD 204 and RAD 202, we believe that we will have the phase I data readout at the end of 2026. Two full phase I, one full phase II will be this year, and the other two trial also will contribute with the interim data. With this, I would like to thank you for your attention, and I'm happy to take any question.
Thanks, Riccardo. I neglected to make that point at the start. If anyone has any questions, we've got some time to take them. Please, in the audience, feel free to use the Q&A function, and we'll get to those in a moment. Just a general one to start, Riccardo. I think a lot of people have heard how hot the radiopharmaceutical space is. Has that momentum in general continued, and can you just speak to what's going on, in the broader environment?
Yes, I would say so. We continue to receive a lot of requests of interest and of conversation for multiple companies. There is a limited number of radiopharma company, in particular a public company. By the way, three are in Australia. That is pretty unique. But there are probably only other three or four on the Nasdaq in U.S. There is scarcity of company that has experience in radiopharmaceutical and are in clinical stage. For this reason, we think that the momentum should continue.
Very good. A question from the audience: Has there been any suggestion of efficacy for RAD 202 or RAD 204 at the first few cohorts?
Yes, very good question. We wanted to start from a low dose, and the reason is, you know, the basic principle is not to harm a patient in a clinical trial. We wanted to be very cautious. As I show, we are dosing patient between 75 and 90 millicurie. That's our current dose. The approved products from Novartis, called Pluvicto and Lutathera, are dosed at 200 millicurie. We are still below 50% of what is potentially the final dose. For this reason, as expected at this stage for the reported data, we have not seen clinical efficacy because the dose is too low. What is interesting is now we are moving from now on to cohorts that start to be above 100 millicurie.
This is when, you know, 100 versus 200, you start having a possibility of having clinical results and you will continue when you go up. The second part of 2026 is when we are dosing patient with an amount of active compound that is more likely to give clinical efficacy. We are very pleased with the safety. That is the starting point. Now we are moving to test for efficacy.
Very good. Next question I had was just how do you, obviously you've got a large pipeline, so how do you prioritize between, you know, that broad pipeline expansion versus focusing your capital on, you know, smaller number of assets?
Yes. For the time being, we do have the capabilities of, you know, as a team and financially to do the four phase I therapeutics and to complete the phase II of the imaging. With advancing the data, we will have more knowledge if any of the four molecules need to be prioritized compared to the other. But at the beginning, it's very difficult. You want to have, you know, multiple shots on goal, at least at the beginning when you don't have a lot of clinical data, so that you can properly decide. We are good as we are for the time being, but we will make a decision and a selection in the second part of the year of what products deserve to be accelerated versus others that can go a little bit on that backburner.
Very good. Another question was just what are the biggest execution risks that you think the company will face over the next sort of one to two years?
Yeah. Look, the oncology field is very crowded. You know, there are many companies with different modalities from, you know, CAR-T, new approach to chemotherapies, ADC, cell and gene, and bispecific, and so on. The most significant hurdle is always to have the hospital deciding to allocate a patient to your trial instead to another trial. It's not competition with other radiopharma companies, it's a competition with any compound. It is important that you select center where there are no competing trials in the same indication, and you, of course, explain very well the benefit, the potential benefit of your products to the principal investigator. The trial recruitment is, for everybody, a challenge, and requires a lot of preemptive work to go as fast as you would like to go.
We don't see any challenge in terms of the sector specific. We have abundance of radioisotope that we need. We don't have a supply chain challenge. We are well-organized to ship our products from the production to the clinical center on time. We don't see challenges in this direction.
Very good. You've obviously raised, you know, some of your capital through the U.S. and had quite a lot of interest in the U.S. where you're based, as well as having the Nasdaq listing. There's sometimes been a bit of a disconnect between what's happened on the Nasdaq and the ASX. Can you just speak to your view on, you know, do you think there's a bit of a disconnect there in understanding and why you think that might be?
Yeah. It's always difficult, you know, when you go out with a press release, you go Australia first and then U.S. is reacting after, you know, 12 hours. There is always possible that there is some sort of arbitrage here and there. For the time being, we see that the price at the Nasdaq is probably 20%-25% premium versus ASX. I don't know why, it's always difficult to say, but I think it's also potentially because we are a company of limited dimension. I'm sure that everything will settle. It's also only a little bit more than a year that we are on Nasdaq, while it's almost five years that we are on ASX. We like this opportunity.
We like the opportunity to be exposed to our primary market, that is Australia, and will continue to be Australia, but also to have funds that, you know, can invest only in U.S. company, and so they have the opportunity to buy the stock if they decide to.
Very good. Just one final one. I know you touched on some of the upcoming stuff a little bit there, but just to summarize for everyone to finish off, you know, what are the main catalysts that they should be looking for from the company through the rest of the year?
Yes. If we look at mainly, the most important catalyst, we will have the phase II readout of RAD 101 between May and June, and we will have the phase I readout of two therapeutic trials, RAD 204 and RAD 202, before the end of the year. In 2026, we will have one phase II and two phase I readouts.
Very good. Well, Riccardo, thanks for your presentation and your time today. If anyone has any questions, I know Riccardo would welcome them, and his details are available on all the announcements. Thanks again, Riccardo.
Thank you for having me. Bye.
Next up with the conference, we have Paradigm Biopharmaceuticals, PAR, at 9:00 A.M. Look forward to having you join us for that one.