Thank you, everyone, for joining us today. I'm Spencer Kent from the Cowen Healthcare Investment Banking team in San Francisco. I'm pleased to introduce Oncoinvent and its CEO, Øystein Soug, for a presentation today, and I will turn it over to the company. Thank you, and welcome, everybody. Yeah, my name is Øystein Soug. I'm the CEO of Oncoinvent, and we are a radiopharmaceutical company dealing with alpha emitters, obviously, in oncology. We have a unique mode of action which differentiates ourselves from the classical radioligands that I'm going to present to you today. We are already in phase two, so we have some phase 1/2a data that I'm going to show you today with some pretty good data. We believe that if we are able to reproduce the data we have in the early phases, in the later phases, we will have game changers both in ovarian cancer and in colorectal cancer. Our prime focus is ovarian cancer, where there is a very high unmet need, and also in our niche, very limited competition. We also think that in a marketplace, we will be well positioned because we do not change the standard of care. This is a treatment you can put on top of what is already there. Last but not least, we have an experienced team that has already done this before. Now, the indication we're going after primarily is peritoneal carcinomatosis or peritoneal metastases, which is not really an indication per se, but it's a state of disease which arises in many types of cancers. The idea that, or the insight which led to this invention, which underlines our technology, is the fact that the peritoneum is a closed compartment, which lends itself very well to direct treatment of radiotherapies. Essentially, to make it simple, you can fill the peritoneum with radioactivity, kill the cancer within without causing harm to tissue outside the peritoneum. That's the idea. Now, the way these patients are being treated today is with chemo, but primarily with surgery. Surgery works. It gives the patients approximately one to two years extra life, but it's a big surgery. The patients are being opened. The abdominal cavity is being opened, and the abdominal walls are being scraped, and the surgeon then looks for visible signs of cancer before the patient is being closed up again with an indwelling catheter. No matter how good the surgery is, there is going to be micrometastases left in the peritoneal fluid and on the peritoneal wall. Our promise, what we are trying to do, is to kill off those micrometastases and thereby prolong the life of the patient. The name of our product candidate is Radspherin. It is radium-224 labeled on microparticles. The product itself is about a quarter of a liter of a milk-like fluid, which we inject directly into the peritoneum to kill cancer. The shelf life is eight days, which is very good in this business. It means we can do centralized manufacturing in our pilot plant in Oslo, Norway, and send around the world. In phase two, we are currently treating patients and shipping to sites in the U.S. How does it work? The patient is--this is a big surgery. The patient spends about a week in hospital after surgery. Approximately on day two, the patient will be treated with Radspherin. Through an indwelling catheter, this quarter of a liter of a milk-like fluid is then being injected into the patient. It is highly radioactive, and it will kill off the cancers in the peritoneum, approximately 75% during the first week, clinically relevant activity for perhaps two or three weeks. It is a solid jolt that comes during the first week, and we think that is exactly perfect for this indication. You might ask, how can you kill off all the micrometastases? How can you kill all the cancer while leaving the healthy tissue unharmed? The answer is twofold. The most important part of that answer has to do with the range of the alpha particle. Alpha is very potent, but it has a very short range. It's approximately 0.1 millimeter or 2-10 cell diameters, which means that whatever is inside the peritoneum of organs like the small intestines and the stomach and the liver, they are covered by a lining which is thicker than the range of the alpha, thicker than 0.1 millimeter. The alpha particle just bounces into that lining and not causes harm to the organ itself while killing everything which is floating around like the micrometastases. The second reason has to do with the construct itself. The microparticle, there are millions of microparticles in this fluid, but they are so small that they act like a fluid. They will be able to reach every part of the peritoneum, but they're so large that they do not escape the peritoneum and into blood or adjacent tissue. Thereby the good side effect profile. The history of this company goes back to the gentleman in the lower right-hand corner, Roy H. Larsen and Øyvind Bruland. They are the inventors of the technology and the founders of the company, but also the inventors and the founders of companies like Algeta and Artbio. Artbio is a Boston-based company that some of you may have heard of. Algeta developed Xofigo, which was the first alpha emitter, and so far the only alpha emitter on the market. Algeta was an Oslo-based company and Oncoinvent as well, which means that some of the same people are in both companies. Approximately half of the board and half of the management team consist of people with senior experience from Algeta, which thereby have a proven track record of taking alpha radiopharmaceuticals to an approval, to the market, and also to an exit. Algeta, as some of you might know, was sold to Bayer for $3 billion. This is the snapshot of the radiopharmaceutical landscape seen from our vantage point. You will see the radioisotopes on the x-axis and the indications on the y-axis with a heavy concentration in neuroendocrine tumors and in prostate cancer, simply because that's where Novartis has succeeded with Pluvicto and Lutathera. Also, Xofigo here is the third box with a red frame, which means that it's on the market. Everybody else is trying to do, I shouldn't say everybody, but 60%-70% of the clinical trials in this area are in these two indications, PSMA and GEP-NET, meaning that they're trying to emulate or improve what Novartis is already doing. It is a very high concentration, both on the alphas and the betas. There's a high concentration. Now, radium-224 is alone up in the corner here. That is not because radium-224 is a bad isotope. As I've explained, it's actually a brilliant isotope. Half-life of 3.6 days is perfect for cancer indications, but it doesn't chelate well. You cannot make a radioligand out of it. To us, that's not a problem. That is a plus. When you go after cancer in the peritoneum, you don't need a radioligand. We have a much, much more simpler mode of action where we do not use it systemically. We use it directly. That has many great advantages, we believe. By bypassing the biological targeting, we are able to retain the radioactivity close to the tumor site for a longer period of time. We can thereby increase the dose. We can give a much, much higher dose than what we could have done with a radioligand systemically. We also reduce the exposure to sensitive organs. We believe that in some indications, at least, the direct alpha therapy approach is to be preferred. This receptor independence or the lack of biological targeting also means that it does not really matter where the cancer comes from. As long as it is a peritoneal metastasis, we do not really care whether it comes from pancreatic cancer or colorectal cancer or whatever. Because due to our mechanistic mode of action, we will kill off the cancer cells with a double-stranded DNA break. It does not really matter what nature the cancer cell is. As you can see here on the right-hand side, there is a long list of primary tumors that can lead to peritoneal metastasis. The market is large. For us, ovarian cancer is an important starting point. What is special with ovarian cancer is that these patients, they will not get metastases in other organs. They will primarily and almost exclusively get metastases to the peritoneum. They will also be diagnosed quite late. 70% of these patients will already have peritoneal metastasis. They will be stage three and stage four at the time of diagnosis, which again means that what kills the ovarian cancer patients is primarily the peritoneal metastasis. Getting local control of the peritoneal metastasis is very important to increase the life and the life quality of these patients, which also the FDA realizes and agrees with us as they gave us fast track last year for ovarian cancer. We're also developing Radspherin in colorectal cancer. You might say, well, that's a much messier indication because these patients, they also get metastases in other organs. Yes, they do. Only one third of these patients will have metastases in the peritoneum only. Another third will have other types of metastases, and the last third will get both. The peritoneal disease is really the driver also for the colorectal cancer patients. As you can see here, your life expectancy is being cut in half if you get peritoneal metastases versus other metastases. The five-year survival is reduced from approximately 50% with any metastases other than peritoneal metastases. Peritoneal metastasis on top or instead will reduce the five-year survival rate from 53% to 19%. Clearly, also in colorectal cancer, this is a tool which is lacking in the toolkit to get control of the peritoneal metastases. This is the program, the clinical development program that we have today in colorectal cancer and ovarian cancer. You will see on top here is an ovarian cancer phase I trial, which will have a readout in the first half of 2025. That is the 18-month readout in a 24-month trial. The 24-month will come in the second half of the year. What we are measuring here is recurrence. The same in the colorectal cancer phase 1/2a trial, which has its final readout in the first half of this year, which is then an 18-month readout. These data, the final data and this interim data coming out in 2025, is, of course, quite important and exciting for us in the company. Even more important is, of course, the phase II trial that we have started in ovarian cancer. That is the main driver of the value in this company. It's a 96-patient trial where we last week announced recruitment of the first six patients in the safety lead-in, which will then, during March, allow us to start a randomized phase of this trial. Also, we have plans of starting a phase two in colorectal cancer trial as well. As you can see here, it's listed at TBD, where we have not yet pushed the button, but it has been cleared by regulators on both sides of the Atlantic. Now, we'll take a look at the data from the ongoing phase 1/2a trial. First, we'll take a look at the colorectal cancer trial, where 20 patients have reached the end of the trial or 18 months. Eighteen months here is no coincidence. That is the expected median for these patients. We'll see the historical control. 50% have had recurrence at 18 months. The Radspherin group who got standard of care plus Radspherin, only 15% had recurrence. Admittedly, this is not a large trial. It is 20 patients, but it is 18 months. There is clearly activity going on with the Radspherin patients in this trial. The historical control here is a good historical control. A large portion of these patients were treated at the same hospital by the same physicians in the same time period as the Radspherin trial. It is a very good historical control. We are very happy with this data, and they are as good as we could have hoped for. We are treating the peritoneum, right? It is only the peritoneal recurrence rate which is affected by our treatment. If you take a look at the overall recurrence rate, the data translates well and also has a meaningful difference on the overall recurrence rate in the colorectal cancer patients. In the trial in ovarian cancer, 10 patients are halfway through this trial, 12 months. The overall recurrence rate and the peritoneal recurrence rate is the same because they do not have mets in other organs. Also here, we see a meaningful difference between historical control of 25% versus 10% recurrence in the Radspherin group. The final data in this trial is expected later this year. The idea of this drug taking advantage of the close compartment nature of the peritoneum was that there is not going to be any systemic radiation toxicity in other organs. We do not see that either. We see that this is very well tolerated and safe to use. We've had 40 serious adverse events so far. Only two of them have been seen to be related to Radspherin. And to be fair, they are also long shots in those respects. Those are extremely well tolerated. We see no evidence of systemic radiation toxicity in other organs. The majority of the radiation stays in the peritoneum. When we look at toxicity in other organs, these levels are extremely low. The same with blood and urine. It's so low, it's almost not detectable. This being alpha, of course, you don't need any special precautions at the hospital like a beta emitter would need. It has a very good safety profile. Taking a look at the phase two trial, which has started, we have identified a patient group which has very few options today. These are the patients that are HRD negative, which means they will not get PARP inhibitors. These patients will have an expected overall survival of approximately 40 months and time to recurrence of 12 months. This is the patient group that we have chosen. The safety run-in has just been completed, as I said, with six patients. We will now start a randomized cohort with 90 patients, randomized two to one, looking for PFS, peritoneal PFS, and overall survival, among others. The trial is being run currently in six study sites, but we are increasing that number by at least a factor of two in the US, U.K., EU, and Norway. When and if we get to the market with this product, we also think that we will have some good or some strong advantages. One is that we do not have to change the standard of care. The physicians, the oncologists, and the surgeons, they will not need to rethink the way they treat their patients. The patient will be in the ward approximately a week after surgery. He can be easily then treated with this one injection of Radspherin while she is in the hospital. It's really simple and quick. Also, from a competitive point of view, we believe that we have quite a bit of protection from our unique mechanism of action, which we seem to be pretty alone in applying. We also see that although many are trying and big pharma is trying to do something in peritoneal metastases, nobody's really succeeding, other than to a limited extent with chemo. We believe that from that point of view, also, it's almost virgin territory. Last but not least, strategically, since we are improving surgery and surgery is going to be a mainstay of the treatment of these patients, we are not really worried about good treatments that come before surgery or after surgery. We can live with that because surgery is going to stay and we improve surgery. We think this aspect reduces the risk quite a bit in developing a drug because quite often in drug development, you see that this is the one reason that drugs do not reach the market. That is not going to happen to us. In terms of market size, looking at ovarian and colorectal alone in the EU and Europe, we get to a number of approximately 65,000 patients that can be treated with Radspherin. That's obviously a very big number, but it does not take into consideration other geographies or other primary tumors. Clearly, the market here is the market potential is large. That takes us to the summary. We think this is an interesting differentiated radiopharmaceutical opportunity in that it has a very high unmet need and very limited competition. It adds on to and slots into the standard of care without changing the established treatment regimes. Its targeted non-biological receptor-independent mode of action, which is really different. We think a big advantage when it can be used in a closed compartment in a body cavity. Do not send it through blood if it does not have to be sent through blood. That reduces the risk quite significantly. We already have some signals of efficacy. We believe that this could be a game changer in both ovarian and colorectal cancer. Last but not least, we have done this before. That concludes my presentation. I don't know if there are any questions in the audience. Where are you manufacturing these radiopharmaceuticals? Are you using CDMO? I'll just repeat the question. The question is, where do we produce? In the early days of this company, there was investment made into a state-of-the-art laboratory or a pilot plant in Oslo. We are actually sitting in that facility today in Oslo where we are producing. We have done all the development work in that facility and produced for phase one, and now we're producing for phase two. During the phase two, we will identify contract manufacturers on both sides of the Atlantic for the phase three and commercial, where we need to produce more doses in a larger facility. Of course, we also probably want to have two facilities for the long run. Is the supply easy here across both Atlantic? Are you saying both sides of Atlantic, or are there very few places where you can actually get this from contract manufacturers? This is actually quite simple in terms of manufacturing, at least for alphas, because we have a 3.6-day half-life and an 8-day shelf life. We're not really restricted by needing to produce close to the hospital. As we do today, we can ship on one side of the Atlantic and treat on the other side of the Atlantic. That is possible today. Also, with radium 224, having thorium 228 as the mother compound, it's quite easily available. It exists in nature, and it's also a waste product from uranium production. There are commercial producers of thorium 228, even in Norway, that we can source from. Producing just-in-time radiopharmaceuticals is never simple, but compared to many of our peers and competitors, what we are doing is relatively straightforward. Good. Thank you.
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