Ladies and gentlemen, welcome to this webcast where we will give a voiceover to the data that we presented this morning in a press release on our final data on our colorectal cancer trial. Together with me today, I have Sara Westrøm, Medical Science Manager, and myself, I am Øystein Soug, the CEO of Oncoinvent. It's a possibility to ask questions during this webcast. There's a chat where you can post your questions, and we will answer them towards the end of the session. First, a bit of background. I presume that most of the people following this webcast, you will remember that we are developing RadSpay in peritoneal carcinomatosis in two indications: ovarian cancer and colorectal cancer. We have three trials, and what we're presenting to you today is the final data in the colorectal cancer trial, the phase I/II-A trial, as you can see on this overview. Peritoneal carcinomatosis, or peritoneal metastases in colorectal cancer, is a huge challenge. Up to 25% of the patients will experience metastases to the peritoneum during their illness. This is a problem due to bowel obstruction or other problems with the small intestines that cause the patients a lot of problems: weight loss, repeated hospitalizations, and at the end, quite often also to death. The way these patients are being treated is normally through surgery. There are not too many other options available to these patients, but sometimes HIPEC is added on top. HIPEC is heated chemotherapy, which is then circulated in the cancer site right after surgery. No matter how good the HIPEC and no matter how good the surgery, there's always going to be micrometastases left in the peritoneal fluid and on the peritoneal wall. Inevitably, these micrometastases will cause the cancer to return, and the patient will experience progression. The promise of our treatment, the promise of RadSpay, is to kill off these micrometastases and thereby prolong the life of the patient. In colorectal cancer, approximately two-thirds of the patients that experience recurrence will experience recurrence in the peritoneum: one-third in the peritoneum only, one-third distant only, and one-third approximately combined. The problem here is that whereas you do have tools in the toolkit to control metastases to the lung and the liver, which are the typical distant metastases in colorectal cancer, there really aren't any good treatments other than surgery for peritoneal metastases, which means that when the patients experience recurrence to the peritoneum, the life expectancy of that patient is being cut in half. If you look at the five-year survival, where you see a 53% survival after five years when the patients are distant metastases only, it falls to 19% if you add peritoneal metastases to the mix. Clearly, in colorectal cancer, peritoneal mets are a key driver of mortality and a problem that clearly needs to be solved. The trial that we are presenting data from today, RAD-18002, is the treatment of RadSpay after surgery and HIPEC. As you can see illustrated on the bottom here, we started with a dose escalation cohort. We had an expansion cohort at the end with 30 patients. In between, there was a split dose with three patients that got the 7-megabecquerel top dose split in two. All the 36 patients that were dosed with 7-megabecquerel are the basis for the data we are looking at today. The trial was conducted in Oslo with the PI, Stein Gunnar Larsen, and in Uppsala with the PI, Wilhelm Graf. Now, finally, I will give the word to Sara, who will give you a voiceover on the data. Sara. Thank you, Øystein. Here comes what you've been waiting for, the data update. This is the final data for the 36 patients that have received the 7-megabecquerel dose. What we see now is that after 18 months follow-up, 10 out of the 36 patients, meaning 27.8%, have experienced a peritoneal recurrence in this time frame. This translates or corresponds, compares favorably to the expected recurrence rate in the historical controls, which is where you could expect approximately 50% of the patients to have experienced a peritoneal recurrence at this time point. This is very encouraging data. We are very happy about it, and we think the outcome represents a meaningful effect in patient populations, patient population where new treatments are desperately sought after. It is, of course, important to note that this is a single-arm trial, so we do not have a control group to compare our results with directly. That is why we use the historical controls where patients have also received surgery and HIPEC to provide a context for our results. This cannot measure up to the strength of a direct comparator in a randomized control study, but it still gives you some insights. With the clear separation and the marked difference between our 27.8% and the reported 50% from the literature, we still consider this a very strong signal of efficacy. This is also in line with what our principal investigators are saying. Here you have some quotes from them with Dr. Stein Gunnar Larsen from the Oslo Radium Hospital here in Oslo, stating that the outcomes that we see in this trial exceed his expectation for this challenging population and that he is hopeful that this promising therapy will become an option I can offer to future patients in need. This statement is also backed up by Professor Dr. Wilhelm Graf from the Uppsala University in Sweden, where he kind of says that colorectal peritoneal metastasis is a major therapeutic challenge and there are limited effective options to treat these mets. That the outcome or the findings, the data from the study demonstrates both a clinical promise and a favorable safety profile. And with Dr. Graf's mentioning of the safety profile, we would like to remind you also a bit that with any drug you investigate and also for radiopharmaceutical like RadSpay as a part of the phase I study, to look at the main objective of the study is, of course, to look at the safety. What we see now in the final data is that it kind of confirms the favorable safety profile after RadSpay administration across all the dose levels. That is in 47 patients. RadSpay has been confirmed to be well tolerated and it's safe to use. We have not seen any dose-limiting toxicities. There has also been no reported deaths. It's, of course, important to understand that this is quite sick patients undergoing a comprehensive surgery. You will see some events or adverse events. From the ones that have been reported, only a series, only two of them were reported as possibly related to RadSpay. The investigators, what they are saying is that they have not seen any events that are surprising or that they are unexpected, and also no events coming up at a higher frequency than what they would expect in this patient population and after the treatment with surgery and HIPEC. Furthermore, with the radiopharmaceutical, it's, of course, important to know where your radiation dose is going in the body. What we see here with RadSpay is that the radioactivity is retained in the peritoneal cavity, which is what we want because that is where the peritoneal metastases are located. Furthermore, we see that there is very limited of the radium-224, which goes out into the systemic, so it's redistributed to blood. We don't see any effect on blood parameters. When we have measured the absorbed doses to other organs outside of the peritoneal cavity, they are way below any limits associated with toxicity. Another important feature is the safety profile for the hospital staff, the ones that are caring for the patients. You see that it's a very low exposure of radioactivity. That's partly because you have low radioactivity amounts in blood and in urine. Also, because this is an alpha emitter, you have very limited with a very short range. There is very limited radiation field outside of the patient. There are no precautions needed either to shield the patient or the patient doesn't need to be isolated. With that, I will conclude the presentation of the data, and I will leave the word back to Øystein to summarize and conclude. Thank you, Sara. As Sara says, safety is, of course, very important in developing a drug and particularly a radiopharmaceutical drug. We are very happy to yet once again have the safety profile confirmed of this drug, which is essential if this is going to be a drug. It really increases the probability of this becoming a drug one day. Also, the efficacy, of course, we are very happy to see that we can produce a meaningful effect in this area of enormous unmet need. There is no control arm here, so we still consider this to be a signal of efficacy. Particularly in combination with the ovarian cancer data, which points in the same direction, we believe that the sets of data, they actually strengthen each other. What does this mean? It means that we are on the way of confirming the mode of action. This is the largest data set that we've published so far. It strengthens the case in colorectal cancer. Since the diseases are so similar in these various indications, we also believe that the data strengthens the case for treating peritoneal metastases in other indications, including ovarian cancer. That was the data. When it comes to the future, this is an overview of the data. Tick in the box on colorectal cancer today. In the fall, we will have 10 patients' ovarian cancer phase I data before we will, at a later point, show you the nine-month data of the ovarian cancer phase II, which is ongoing. That is going to happen in the second half of 2026 according to plan. Just to remind you, ovarian cancer data also looks good. The 10 patients after 18 months, only 10% on RadSpay had recurrence versus 40% in historical control. The ongoing phase II trial looks like this. We are now part of the safety run-in, which was in March. We are well underway with the randomized cohort. That trial is recruiting at a steady rate. We are not guiding on a date of full completion of that trial, but we are guiding on the interim data at the end of 2026. So far, that trial goes according to plan and progresses as it should. Now, you can see we have six study sites in this trial: Norway, Belgium, Spain, the U.K., and the U.S. Just to be sure and just to hedge the robustness of this trial, we will, during 2025, also increase the number of sites here from six to up to potentially 12 sites of the trial. Just a final reminder of the financial calendar. We have a half-year report, second quarter at the 27th of August. Then we will have a company update on the 20th of November. With that, we conclude the presentation of the data, and we will take a look and see if there are any questions that have come through on the chat. Let's see. Does the company have firm external BP interest in CRC results that you shared today? It is probably BD, business development. Big Pharma. Big Pharma, yeah. Based on the data that we released this morning, no, not yet. Of course, we are working steadily with pharma companies with the aim of getting validation also through business development. What is the plan going forward with data this encouraging? I think the way the company is structured today, we have put emphasis on developing this drug primarily in ovarian cancer. This data for us, as I already also mentioned, it means primarily that it strengthens the case for treating peritoneal metastases, period, no matter in which indication. It strengthens the case for RadSpay also in ovarian cancer. That being said, we are enthusiastic about colorectal cancer still. We, together with our principal investigators in colorectal cancer and key opinion leaders in colorectal cancer, still have a desire to continue development in colorectal cancer. At what point that is going to happen in the future, I guess it'll be up to potential partners and the capital markets. At the moment, today, the data means a strengthening for the case in all indications and primarily ovarian cancer. With RadSpay as a treatment, improved primary cancer treatment in the malignancies causing the metastases to the peritoneum, ease of access for chemo and/or immunotherapy. That's a question that I will give to Sara, I think. Given that, can I just read it one more time, [to that]? Treatment improved primary cancer treatment in malignancy. Yeah, if I read the question correctly, for instance, you have some types of primary colorectal cancers where you have a high risk of developing peritoneal metastases. That is also something you can recognize if the tumor has kind of grown through the wall of the colon. These patients have a higher risk of developing peritoneal metastases afterwards. There we think it can be as a prospect for future use of RadSpay to kind of use it prophylactically to try to prevent peritoneal metastases to develop. This is also quite common in gastric cancer. You can also have some patients which have a positive cytology, meaning that they have indeed their peritoneal fluid. You can have cells, and this can be an indication that the cancer is on the way or starting to spread to the peritoneum. In this indication, there might be a prospect for RadSpay in the future, although it's not something that we're actively pursuing at the moment. I hope that answered the question. Yep. Say it again. There are some more questions. Go up. Could you explain what the historical control is versus HIPEC combined with CRS treatment data? The historical control here is a combination of different trials where standard of care, meaning surgery and HIPEC, is being used alone without RadSpay, obviously. There are a number of these trials that we can look at. The ones that are the most similar to our patients, which we consider to be the highest quality trials, are the ones that we are basing our 50% on. Yes, it is surgery and HIPEC. Is there a potential for a larger investigator-sponsored trial to add to the body of evidence while focusing on ovarian cancer? We do not have any plans at the moment of starting an investigator-sponsored trial. Clearly, in the future, that could be a possibility. We also believe that these data will make that easier, either investigator-led or sponsored by ourselves or a partner in the future. How long is approximately the current runway in terms of cash? Today, we have a runway into 2026. I think that was the last question. That was the last. That was the last question. By that, I thank you very much for attending this webcast. We will see you next time at the 27th of August. Thank you very much. Bye-bye. Bye-bye.
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