Ladies and gentlemen, welcome to Oncoinvent's first half-year presentation. My name is Øystein Soug. I am the CEO, and with me today I have CFO Ramzi Amri. I would like to remind you that you can ask questions online that we will attempt to answer towards the end of the presentation. We have a short and sweet presentation for you today. We will go through the highlights, give you a clinical update, a financial update, and a bit of outlook. So far in 2026, development has been good for Oncoinvent. Clearly the most important value driver in the company for us today is the execution of the phase II trial in ovarian cancer. We included four additional sites into that trial during the two first quarters. Now we have 55 patients recruited into that trial. That trial is on track. We also strengthened our IP position in China with a new patent. On the scientific front, we had lots of activity in the two first quarters. First of all, we presented our phase I data from the ovarian cancer trial at ESGO, which is the largest gynecology conference in Europe. We recently also published dosimetry data in the European Journal of Nuclear Medicine and Molecular Imaging. Also for congresses later in the fall, in October, we have abstracts accepted at ESMO, which is the largest European oncology conference, and EANM, which is the largest European radiopharmaceutical conference. Last but not least, we appointed our new CFO, Ramzi Amri, which you met at the last quarterly presentation. Going into 2026, our priorities was clearly to speed up the recruitment rate in the phase II trial. By now we have had the two best quarters in the first quarter this year and the second quarter this year, and we are across the halfway mark of that trial when it comes to recruitment. I think we can check that box. We also promised the market that we will include more sites into the trial, and we did that. We have four more trials, one in Italy, one in the U.K. and two in Spain. Now there are 10 sites active in the trial. We also promised the market that we will do some small protocol amendments to smooth the recruitment of the trial, and we did that. We also promised the market that we will be careful using cash, not more than we have to. I think we can also check that box. I believe that we have delivered against our priorities so far in 2026. When we are getting closer to the next phase of development of Radspherin, of course, we are ramping up for that as we speak. We are starting to get phase III ready by planning for a phase III trial, writing the protocol. We are securing raw material supply for the trial, and we are setting up manufacturing for the phase III trial and beyond. CFO Ramzi Amri will say a few words about that in a later section. Before we get there, I would like to remind you about what we are doing at Oncoinvent, very briefly. The problem that we are aiming to solve is cancer that has originated in or are spread to the peritoneum or the abdominal cavity. The peritoneum is a special organ in the human anatomy because it has very poor vascularization. It means that blood vessels do not penetrate into that part of the body very well. That means that drugs that rely on systemic delivery being sent through blood, like targeted therapies, they tend not to be very effective in that part of the body, in the abdominal cavity and in the peritoneum. Cancer spreads to the peritoneum, and the way that cancer in the peritoneum is treated today is primarily with surgery. It is a comprehensive surgery, but no matter how good the surgery, there will be micrometastasis left in the peritoneum, on the peritoneal wall, in the peritoneal fluid that eventually, in most cases, would cause the cancer to return, and in many cancers also drive the mortality in this patient population. If you can kill off those micrometastasis, you will prolong the life of the patient, and that is what we are attempting to do with Radspherin. The way we do that is with a microparticle labeled with radium-224, which is an alpha emitter, which we inject into the peritoneal cavity as a fluid, filling the abdominal cavity and irradiating the peritoneal wall and the peritoneal fluid, and eventually killing off all the micrometastasis and thereby prolonging the life of the patient. Now, when and if this product reaches the market, we believe that it will have a good uptake. The primary reason for that is, of course, the high medical need that we face today. As I said, there are really no good modern medicines to treat this disease. Not only in ovarian cancer, in colorectal cancer, but metastasis to the peritoneum is a big problem for all cancers that spread to the peritoneum. We start in ovarian cancer, as ovarian cancer primarily spreads to the peritoneum, and it is a leading cause of death for these patients. In addition to that, we have an FDA Fast Track designation in ovarian cancer. So far, we have seen good signals of efficacy with Radspherin, and we have seen a very good safety profile. We believe that a strong safety profile is very important in radiopharmaceuticals, and it will support the broad usage of the drug when and if it reaches the market. It is also a one and done treatment. It means that it is one injection when the patient is still in the hospital recuperating after surgery. The injection takes about four minutes. It is painless, and it does not add to hospitalization stay. It fits seamlessly into the existing standard of care that the patients are receiving today. We believe that if and when our product candidate reaches the market, it will have a strong and swift adoption. Looking at our clinical development plan, you will see here up in the left-hand corner that we had two trials finishing last year. There was a phase I in ovarian cancer and a phase I/II in colorectal cancer that read out with good results. Notably, ovarian cancer, one out of 10 patients, or only one out of 10 patients, had recurrence after two years, which is a very meaningful result in this patient population, and it has led us to start a phase II trial in ovarian cancer. In this trial, we are guiding that we will have interim results later this year and next year. If everything goes according to plan, we might be able to start a phase III trial in ovarian cancer as early as 2027. As I mentioned, the work stream, which is the most significant value driver for our company today, it is the execution of the phase II trial in ovarian cancer, which is on track. As I mentioned, the recruitment momentum has improved significantly in 2026. We now have 10 hospitals active versus six last year. We have a few amendments that we have added to the protocol. They are, I would say, fairly insignificant in the sense that they do not change the homogeneity of the patient population but irons out some of the wrinkles when it comes to recruitment. It has led us to have 55 patients in the trial by the end of June. In the period after June, we had two weeks of manufacturing halt for maintenance reasons. This is a scheduled maintenance that we have to do every year. In spite of that, the third quarter has started well, and we also plan to add a couple of more hospitals as recruiting sites into the trial during the next two quarters. What I am showing you here is the recruitment rate per quarter since the start of randomization at the first quarter of 2025. As you can see, the two best quarters in the trial are the first quarter this year and the second quarter this year. Already by May in 2026, we had recruited more patients than we had during all of 2026. The trial is on track. With that, I hand the floor over to CFO Ramzi Amri. Thank you, Øystein. Good morning, everyone. For our financial update, we will give you the brief. As of June 30, the cash and equivalents totaled 109 million NOK, rounded upwards with 2 million NOK in restricted cash. Based on our current operating plan and the expenditures we are forecasting for the rest of this year, next year, we expect this to fund our operations into 2027 beyond the interim. Expenses are scaling, I would say, in proportion with recruitment. We are, of course, recruiting more patients. We are having more activities because of that, but we managed to keep the costs very much in control. I think that means that there is no material change in the cash burn that we expect, and that is something you can already see in the cash burn on the early half of this year. Our operating cash burn has been NOK 69 million, which is in line with the budget we set and actually slightly below it, and is very much in proportion, if not more favorable compared to the level of activity we had. We see two main shifts, I think, when you compare it to last year's numbers and especially the first half of 2025. First is, of course, the payroll costs, which have increased a bit because of the scaling of the phase II recruitment. Of course, more patients means more manufacturing activity. You see also still a residual effect of the reverse merger and the fact that we are main listed now in Oslo Børs, which of course means that we have some more regulatory obligations, and we need people to actually respond to those. The good news is our operating expenses are very stable. Despite a significant increase in the number of patients we are recruiting and the fact that the phase II is running at full speed, it is on the operational expenses more or less in the same ballpark as the first half of 2025, which shows that we are very much on top of our cost discipline. This is also, I think, seeing the questions that are already being raised in the chat, we managed to keep the cash burn on par with what we expected despite being faster in recruitment than initially expected. That means that our guiding has not changed on that level. That's, I think, in general, good news. For all the detailed figures, of course, our half-year report has been published online. Feel free to look at it, and of course, we are reachable by email if you have any questions. Then on the outlook side of this, beyond the financials, I think it's also important to look ahead a bit beyond the numbers. For our current operations, we are, of course, running a phase II study with the intent to prove with a randomized study that our belief in the safety and efficacy of the product is also proven in a randomized setting. We don't have that data yet, but we are, of course, strongly encouraged by the final data and the evolving data we had in our early-stage studies, and we are confident that those signals will be confirmed in the phase II. That means that the interim analysis that is coming up will inform the decision to advance into phase III, but we are already undergoing preparations into phase III. That's for many reasons, but the most important one, of course, is that we want to be fast into the phase III as soon as we have a positive readout in the phase II. There's multiple things we are doing right now to make sure that that seamless transition happens. The most relevant, of course, is to talk to regulators. The earlier we engage, the better. Since we have a Fast Track designation, we can talk to the FDA fairly often and in detail on many matters that are relevant to an optimal phase III design, and that's something we are also internally working on. We are trying to determine a protocol and a design that learns from the phase II that addresses a large population that we can support and actually treat with our product in ovarian cancer. The second part of it is also to set up a study that allows us to go to approval or at least Accelerated Approval as fast as possible. We are working on this, and it is very important that we have this validation from regulators as soon as we can. The other side of this is, of course, manufacturing. We have the advantage of being able to manufacture our own product in our own site, basically from raw materials to shipment. Our pilot plant is one of our most relevant assets. It de-risks the manufacturing massively. At the same time, we want to be able to have redundancy and cross-supply, so we are looking to identify a CDMO, probably in another region outside of Europe, to be able to manufacture from two locations at the same time. In order to make that efficient, we are, of course, looking at ways to automate and scale up the manufacturing process itself. So we are working for a tech transfer readiness and a scaling project at the same time, and both are tracking as expected and will be in place by the time the phase III would be expected to start. So that would help us accelerate to phase III, but also make sure that there is sufficient redundancy in the manufacturing. As always, we are a small biotech. We intend to do quite a few things on our own because we have the pedigree and the people and the know-how. Once you get into phase III and you have conversations about your commercial future, it is, of course, important to partner up and find strategic partners to work together with to bring this to as many patients as possible in as fast a timeline as possible. That is also something that is an ongoing activity that we always keep high on our priority list and will be even more important as we move into a global phase III trial with a significant uptick in number of patients and treatments. So that is also a priority for us and something we are actively pursuing. All in all, I think we are well on track, as Øystein said at the beginning of the presentation, to actually be ready for phase III and bring it to phase III readiness. Having said that, we would like to now move to the Q&A section of this presentation, and we will address some questions you might have submitted already. Yeah. It's a long list of questions. Okay. Starting from the top, I think we'll have to be selective. There is a long list of questions here. The first question is that you state that selected protocol amendments are improving recruitment. Which eligibility criteria were changed, and to what extent have these amendments increased clinical heterogeneity? I think as I mentioned, these are small and insignificant changes. One of them has to do with the test, whether it's a local test or a standardized test for determining HRD status, for example, which makes it easy for the hospital to recruit patients but doesn't change the patient population. We had a pretty narrow definition of chemotherapy before surgery, we just increased the number of cycles of chemotherapy that are possible, and this is not changing the patient population, we believe, at all. Yeah, there's several questions related to recruitment status of the phase II. As we mentioned, recruitment is on track. I think for the attentive reader of our material, he will see that we announce that we will have the most important interim readout at the end of 2027 or the second half of 2027, which is after nine months follow-up. That means that in order to have nine months follow-up at the end of 2027, we would need to have the last patient recruited during the first half of 2027. We are implicitly guiding that that is going to be possible. With the current recruitment rate, it is going to be possible. That is just plain math. I think that answers several of the questions that are posted in different fashions. Is the planned interim analysis triggered by a predefined number of randomized patients? Yeah, as I mentioned, the main interim analysis, the nine-month interim analysis I mentioned is when all patients have been nine months in follow-up. But the first interim analysis, which is the first look into the data, is set by date. It's just a date that we have set for that interim. It's not driven by any actual developments in the trial. Yeah, there's more recruitment. Public trial registries currently list 14 hospitals for the phase II study, while we report 10 active sites and state that additional hospitals will be added during the second half. We have 10 today. We plan to add another two to three during the next half year. As I said, this trial is now going towards its end, so it's a limit to how many centers we want to include. But we believe that adding new centers now will add to recruitment speed and keep the recruitment speed up, also in the second half of the trial. More importantly, the trials that we have included as active trials in the phase II can be rolled over and hit the ground running, so to speak, in the phase III. We think it's valuable to add more trials. Whether it's 13 or 14, that is just the number that has been reported as we try to recruit, but it's in that magnitude. We will add a couple of more, maybe 3. Yeah. Do you think you can answer that one? Yeah. I see a question here about the spread of ovarian cancer through clusters of cancer mesothelial cells, and the question whether the short-range Radspherin's alpha radiation can treat cell clusters, including cells that have already started to grow into the peritoneal surface. That is a very good question. I think the core of our premise is that we treat small clusters of cancer cells that are left behind after primary surgery. That includes any microscopic seeds of cancer cells. That is exactly what we can actually treat. Of course, the importance is timing. We do this after surgery because that is the best moment to take a good look at the peritoneal surface and check whether anything is there. But whenever there is microscopic seeding, that can be addressed through alpha radiation. It is a short-range radiation, but the idea of our product is that it saturates the peritoneum with such a high amount of radiation that any cells that will be within the compartment will get hit by at least a few alpha nuclei. That does not matter whether those cells are part of the resection or actually stray cells that are invisible to the surgeon. So that is part and parcel of our approach, and I do think it does not matter whether it is an existing cluster or one that is still seeding. Of course, we are exploring options, but that is not in the scope of our current trial to use the product in a preventative way or do it as a second-line defense when patients recur. But for now, the primary ovarian population is the biggest population, the one with the highest unmet need, so that is the one we address. Maybe you take the next one as well, Ramzi. Yeah. Discussions on Radspherin in other indications. As you may know, we have the opportunity to start a phase II study in colorectal. We are prioritizing ovarian because of its potential and higher unmet need, and because we have to focus our financial resources on one study. If we were to find a partner or have sufficient funds, we would be able to start colorectal. We also think there is a high potential in gastric cancer, which is also a fairly large population with a very high unmet need when it comes to peritoneal metastases. In that case, the life expectancy of these patients is expressed in months, so anything that could help is of great use, especially because the vast majority of these patients are resectable. It could be one of the ways to make this a more addressable disease form. Another part of that discussion is, of course, finding potential in Asia to go there because the representation of gastric cancer patients there is much higher. We have ongoing conversations about that. That leads to the next question, whether we are preparing. Yes, we are. We are right now preparing for a phase III outline for ovarian cancer. Of course, that is all subject to regulatory discussions and approvals, but as we have covered in the past, we will try to bring this to as broad a population as possible within the ovarian cancer population in a way that allows Accelerated Approval in a subset and also full approval with the broader ovarian population. While we think the phase II interim will be confirmatory, we think the unmet need is high enough that we will be able to move forward with the phase III fairly quickly. Good. Then we have a couple of questions here from one of our analysts. Can you provide any additional flavor on the recruitment pace so far in Q3? The answer is not more than we actually stated. We have decided to give the exact number at the end of every quarter. But as I said, the beginning of the third quarter is good. Yeah. On cash burn, I think I hinted at this already. The cash burn is expected to continue as we planned, so no substantial changes in our guidance. You announced the acceptance of abstract at ESGO and EANM, or ESMO, I guess, and EANM at LinkedIn, but not through formal information channels. We will do that when we are allowed to say more about the content. Then there will be a press release. But so far, we can notify the existence of it, but not about the content. When we know the content or when we can tell you the content, we will through a press release. Now there's a question which may be a misunderstanding, but I will address it anyway. It said, what is the uniqueness of Oncoinvent Solutions, and are there competition? I believe there's a question whether Oncoinvent ASA and Oncoinvent Solutions are competitors. Actually, it's a daughter company where most of the operations are organized today is called Oncoinvent Solutions, which is a daughter to the listed company, Oncoinvent ASA, and they are not competitors. On the same note, again, I would like to mention that and remind you that we did a reverse merger last year into BerGenBio. When you look at the share price development of this company, it is actually just relevant and accurate going back to December, November last year. Before then, you're looking at the share price of another company. It's BerGenBio. Our share price history starts in November. With Fast Track, Ramzi, can submission be before 2030? Never say never. That's the honest answer. Fast Track can absolutely help because it gives us the opportunity, of course, to have an open dialogue about Accelerated Approval and a subpopulation based on an interim of the phase III. If we launch it on time and it recruits fast, it is possible to have that discussion by late 2029, early 2030. Of course, one of the things that helps with the Fast Track is that you can get a Priority Review, so also the review phase would be a bit faster. It all depends on the design and the number of sites and the speed of recruitment. But I see a question already on this, and Øystein already said it. One of our advantages is that we can, in Europe, roll over the sites from the phase II into phase III, so the start will be, as Øystein said, hopefully already with quite some momentum, especially since we will at least include the existing population in the phase III. The next questions follow the same line here. It says, if the phase II study delivers strong and clinically meaningful results, would you consider discussing Conditional Marketing Authorisation in Europe or Accelerated Approval in the U.S. with regulators? Or do you currently assume that a randomized phase III trial will be required before any application for approval? Formally, the answer is yes and yes. If the data is fantastic, of course, we will talk to the regulators. We expect, and we guide that, of course, we need another trial in addition to the phase II in order to get approval. Of course, the strength of the data will determine this. Not only the strength of the data. There is also a safety database that needs to be filled up with patients. So you need a minimum number of patients to ensure good safety. I think that is the main reason why we believe that at least we will have to start recruiting into a phase III, no matter how good the phase II data is. Will the same hospitals participate in phase III trial? How many patients in phase III, Ramzi? Yes. The answer is yes. We think all hospitals in Europe. Of course, in the U.S., the process is slightly different. Every phase in the study requires negotiations with the sites, contracting, et cetera. But in Europe, you can actually roll over their sites, and most of them are, of course, very excited to do so. That is also the reason why even though we are in the tail end of the phase II, we are still continuing to add new sites. It is something that can boost the recruitment. How many patients in phase III? That is subject to discussion with the regulators. Of course, I think we can say, as with any large phase III study, the number will be significantly larger than a phase II study, but that is also because we are using a larger population, and we want to have sufficient buffer to ensure statistical significance in a subset for Accelerated Approval. The ballpark will, of course, be multiple hundreds of patients. The exact number we cannot disclose right now. I think it's important also to note that in the phase II trial, we're going after a pretty narrow patient population. In order to use a homogeneous patient population, which has a large clinical need, where it's, quote-unquote, easy to get good data. Going into phase III, of course, we are preparing for launching this drug in the market, and then we are thinking bigger. We want to include more patients. So we will include not just this narrow patient population that we have today, but pretty much all patients that can be treated and have a meaningful effect of Radspherin. Yeah. Yeah. There's a question about when interim data is expected. We guide in half years, and we think that is a good idea because quarters are quite short. Since we are in the second half of 2026 already, and we are guiding on interim data in the second half, it is safe to assume that it's going to be late in the second half. When it comes to the nine-month follow-up data, which is the main interim readout, that depends on recruitment. So the recruitment speed for the second half of the trial will determine when all patients are recruited and when the nine-month follow-up is ready. At the current recruitment rate, it's also going to be late in the second half of 2027. Yeah. I see a question on manufacturing. Very briefly, it says, we manufacture 200 doses per year at the current site. We are able to. What do we expect for phase III and commercialization? Well, for phase III, we need redundancy. We need a partner outside of Europe for logistical reasons and for the volume of the trial. That partner is also going to be a candidate for commercial manufacturing. Of course, in commercial manufacturing, the importance is that we can address a much larger amount of doses per week. But the advantage of our process is that the only bottleneck there is human resources, effectively. It's a hands-on process that we can scale at infinitely, provided you have sufficient people working on it on a sufficiently large surface. In Europe, we will also look for a different partner for commercial manufacturing, but we do think that with some additional scaling of our manufacturing process internally, we could supply Europe from our own pilot plant. Of course, we are trying to do that by getting more doses out of each batch instead of making more batches. So the cost component of it will be largely in the development and not necessarily in the cost of goods themselves. We have a question about artificial intelligence. Do you want to say a few words about that, Ramzi? Yes, I think we use AI for many things. I am not going to mention any AI by name. Of course, if AI providers are willing to give us a discount, they can reach out to us. But yes, we are using for many different reasons. I think AI can be very useful as long as you use it in a smart way. It can help making first drafts with regulatory interactions. It can help polish and clean up any scientific work we do. But of course, the human component is also very important. So we see it as an enabler and as an accelerator and as something that makes us work faster. But the talent of the people is actually what moves the needle for us. But we have solutions in place across the organization to help accelerate, and we have seen the effect of that already. There is a question. Can you elaborate on what kind of abstracts has been accepted at ESMO? And the answer is no, we cannot reveal that yet, and we will send a press release when we can. Do we have a target date on partnership agreement? The answer is no. But like any other biotech company, it is, of course, very important to get validation and get someone to buy in on the risk that we are facing. So like any other biotech company, we are working on trying to secure partnerships in many different areas. But how long is a piece of string? It will take time, and it is not happening next week. Yeah. I think I saw a question about whether we are pushing on that. I think the answer is yes. This is our bread and butter. We have strategic discussions, BD discussions with investors at any point in time through the year. That's one of the most important things to do if you're a small biotech and have one shot on goal. We are traveling the world. We are talking to investors wherever they are. We're going to conferences, to meetings, to one-on-one events. Of course, it is promising, but we can't really give you any details. That's, of course, part of the problem of these activities. There is some confidentiality behind them, so when news comes, we'll give it. I think we're getting to the end here. There's some questions that do not look like questions, but there's one here. Can you elaborate a bit on Sara Westrøm, the new scientific director? Sara Westrøm is, I think, one of the first non-founder employees in the company. She's been with us for many years. She's also one of the inventors on the patent of Radspherin. She did her PhD on Radspherin and has been a leading employee within research and development since the beginning of the company. She has a very strong pedigree within exactly what we are doing, and she has also been instrumental in external work in the company with the potential partners. More questions about partnering? Yeah. Do you have more to say about partnering, Ramzi? The question is, you mentioned that a partnership for phase III is required. Are you thinking about big pharma and have any negotiations already been started? Yeah. I can repeat what I was already said. Of course, we can't disclose anything on that. But I wouldn't say that it is required. I think it is beneficial to have partners in phase III. We could, of course, do everything on our own, and that's probably contingent on funding. But we do think that in general in biotech, it is advisable to use both the capabilities, the know-how, and the scale advantage of bigger partners. They don't have to be big pharma. It could also be specialty radiopharma companies. Of course, we have discussions with many of these. The details we cannot disclose, of course. But as I said, this is something that is part and parcel of doing business in biotech, and we take that very seriously and it is basically our daily business. Good. I think that was the last question. Maybe you want to close the session, Ramzi? Yes. So a brief look forward. I think case in point where we are going and where we are talking, these are, I think, a short list of places we will be heading to in the next two quarters, more or less. So take a look at them. If you want to meet us, feel free to come and say hi. We will be at the Nordic Life Science Days in Stockholm early September. We will be to the Targeted Radiopharmaceuticals Summit in New York from Oppenheimer & Co. Inc. We will be at a European Midcap Event in Paris. EANM, ESMO are two places where we will present some results and more to come, of course, about that. Our next update is in October, and across Q4, we will have multiple moments where we will sing the gospel of Radspherin. So hope to see you there. Thank you for joining. Thank you for the many questions. It is very encouraging to see the interest, and we hope to see you next time.
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