Oncoinvent ASA

Ladies and gentlemen, welcome to Encore Elements first half year presentation. My name is Øystein Saug, I am the CEO and with me today I have CFO Ramsey Amri. And I'd like to remind you that you can ask questions online that we will attempt to answer towards the end of the presentation. So we have a short and sweet presentation for you today. We'll go through the highlights, give you a clinical update, financial update and a bit of outlook. So far in 2026, development has been good for Onco Invent. Now clearly the most important value driver in the company for us today is the execution of the phase 2 trial in ovarian cancer. And we included four additional sites into that trial during the two first quarters. So now we have 55 patients recruited into that trial. So that trial is on track. We also strengthened our IP position in China with a new patent. And on the scientific front, we had lots of activity in the first quarters. First of all, we presented our phase one data from the ovarian cancer trial at ESCO, which is the largest gynecology conference in Europe. We recently also published docimetry data in the prestigious journal of nuclear medicine. and 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 and last but not least we appointed our new CFO Ramsey Amri which you met at the last quarterly presentation Now going into 2026, our priorities was clearly to speed up the recruitment rate in the Phase 2 trial. So by now, we have had the two best quarters in the first quarter this year and the second quarter this year. And we're across the halfway mark of that trial when it comes to recruitment, so 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 UK, and two in Spain. So 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. And we also promised the market that we will be careful using cash, not more than we have to. And I think we can also check that box. So 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 Red Ferrum. Of course, we are ramping up for that as we speak. We are starting to get phase three ready by planning for a phase three trial right in the protocol. We are securing raw material supply for the trial, and we are setting up manufacturing for the phase three trial and beyond. And CFO Ramse Amri will say a few words about that in a later section. But before we get there, I would like to remind you about what we are doing at Onco Invent, very briefly. So 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 pure vascularization. It means that blood vessels do not penetrate into that part of the body very well and 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 but cancer spreads to the peritoneum and the way that cancer in the peritoneum is treated today is primarily with surgery And it's a comprehensive surgery, but no matter how good the surgery, there will be micrometastases 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. So if you can kill off those micrometastases, you will prolong the life of the patient. And that is what we are attempting to do with Ratsferrin. and 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 radiating the peritoneal wall and the peritoneal fluid and eventually killing off all the micrometastases and thereby prolonging the life of the patient. Well, when and if this product reaches the market, we believe that it will have a good uptake. And 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 metastases 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 this patient and in addition to that we have an FDA fast track destination in ovarian cancer so far we have seen a good signal of efficacy with Ransferrin and we've seen a very good safety profile and we believe that a strong safety profile is very important in radiopharmaceuticals and it will support a broad usage of the drug when and if it reaches the market. It is also a one and done treatment. It means that it's a one injection when the patient is still in the hospital recuperating after a surgery. The injection takes about four minutes. It is painless and it does not add to hospitalization stay. if it's seamlessly into the existing standard of care that the patients are receiving today. So we believe that if and when our product candidate reaches the market, it will have a strong and swift adoption. So looking at our clinical development plan, you will see here up in the left hand corner, that we had two trials finishing last year. So it was a phase one in ovarian cancer and a phase one slash two in colorectal cancer that read out with good results. Notably, ovarian cancer, one out of ten patients or only one out of ten 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 two trial in ovarian cancer. and in this trial we are guiding that we will have interim results later this year and next year. And if everything goes according to plan, we might be able to start a phase three trial in ovarian cancer as early as 2027. But as I mentioned, the work stream which is the most significant value driver for our company today is the execution of the phase two 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 6 last year. We have a few amendments that we have added to the protocol. They are 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. and 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 calls for maintenance reasons, so this is a scheduled maintenance that we have to do every year. But 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. and what I'm showing you here is the recruitment rate per quarter since the start of randomization at the first quarter of 2025 and as you can see the two best quarters in the trial are the first quarter this year and the second quarter this year and already by May in 2026 we had recruited more patients than we had during all of 2026 so the trial is on track and with that I hand the floor over to CFO Ram Siamri.

Good morning everyone. So for our financial update, we will give you the brief. As of June 30th, the cash and equivalents totaled 109 million NOK rounded upwards with 2 million in restricted cash. and based on our current operating plan and the expenditures we are forecasting for the rest of this year and 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 cost very much in control. I think that means that there is no material change in the cash burn that we expect and that's something you can already see in the cash burn in the early half of this year. Our operating cash burn has been 69 million NOC, 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 25. First is, of course, the payroll costs, which have increased a bit because of the scaling of the phase two recruitment. Of course, more patients need more manufacturing activity. And you see also still a the residual effect of the reverse merger and the fact that we are main listed now in the Oslo Burst, 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 2 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. And 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. So that means that our guiding has not changed on that level. So that's, I think, in general good news. for all the details figures of course our health 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 so for our current operations we are of course running a phase 2 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 two. That means that the interim analysis that is coming up will inform the decision to advance into phase three, but we are already undergoing preparations into phase three. that's for many reasons but the most important one of course is that we want to be fast into the phase three as soon as we have a positive readout in the phase two. There's multiple things we are doing right now to make sure that the 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 three 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 two that addresses a large population that we can support and actually treat with our product in ovarian cancer. And of course, 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 of course it's very important that we have this validation for 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 products in our own site, basically from raw materials to shipment. Our pilot plant is one of our most relevant assets. It risks the manufacturing massively. But at the same time, we want to be able to have redundancy in cross supplies. to identify a CDMO probably in another region outside of Europe to be able to manufacture from two locations at the same time. And in order to make that efficient, we're 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 that phase three would be expected to start. so that would help us accelerate to phase three but also make sure that there is sufficient redundancy in the manufacturing. And of course, 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. But once you get into phase three and you have conversation about your commercial future, it's 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. And that's 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 three trial with a significant uptake in number of patients and treatments. So that's also a priority for us and something we're actively pursuing. So all in all I think we're well on track as I said at the beginning of the presentation to actually be ready for Phase 3 and bring it to Phase 3 readiness. Having said that, we would like to now move to the Q&A section of this presentation. I will address some questions you might have submitted already.

Yeah, it's a long list of questions. I think... So starting from the top, I think we have to be selective. There's a long list of questionnaires. So the first question is that you state that selective protocol amendments are improving recruitment. Which eligibility criteria were changed? And to what extent have these amendments increased critical heterogeneity? And 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've also allowed, we had a pretty narrow definition of chemotherapy before surgery, so we just increased the number of cycles of chemotherapy that are possible, and this is not changing the patient population, we believe, at all. So yeah, there's several questions related to recruitment status for the phase two. And as we mentioned, recruitment is on track. And I think for the attentive reader of our material, you 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. So that means that in order to have a nine-month follow-up at the end of 2027, we would need to have the last patient recruited during the first half of 2027. So we are implicitly guiding that that is going to be possible. And with the current recruitment rate, it is going to be possible. That is just plain math. And I think that answers several of the questions that are posed in different fashions. So, is the planned interim analysis triggered by a predefined number of randomized patients? So, 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, that's more recruitment. Public trial registers currently list 14 hospitals for the phase 2 study, while we report 10 active sites and state that additional hospitals will be added during the second half. So, we have 10 today. We plan to add another 2 to 3 during the next half year. I mean, I said this trial is now going towards its end, so it's a limit to how many trials, 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. But more importantly, the trials that we have included as active trials in the Phase 2 can be rolled over and hit around the ground running, so to speak, in the Phase 3, so 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 more, maybe three.