Oncoinvent ASA (ONCIN.OL) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to Oncoinvent's First Half Year Presentation. My name is Oystein Soug. I am the CEO. And with me today, I have CFO, Ramzi 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. And so far in 2026, development has been good for Oncoinvent. Now clearly, the most important value driver in the company for us today is the execution of the Phase II trial in ovarian cancer. And we included 4 additional sites into that trial during the 2 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 the new patents. And on the scientific front, we had lots of activity in the 2 first quarters. We -- 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 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, Ramzi 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 II trial. So by now, we have had the 2 best quarters in the first quarter this year and the second quarter this year. And we crossed 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 had 4 more trials, 1 in Italy, 1 in the U.K., and 2 in Spain. So now there are 10 trials -- 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 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. And CFO, Ramzi 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 Oncoinvent 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 poor 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 to 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. So -- 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 cases, 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 Radspherin. 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 irradiating the peritoneal wall in the peritoneal fluid and eventually killing off all the micro metastases 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. 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 these patients. And 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'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 4 minutes. It is painless, and it does not add to hospitalization stay. So it fits 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 2 trials finishing last year. So 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, 1 out of 10 patients or only 1 out of 10 patients had recurrence after 2 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. 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 III 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 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 6 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. And it has led us to have 55 patients in the trial by the end of June. In the period after June, we had 2 weeks of manufacturing hold 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 2 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 2 best quarters in the trial are the first quarter of 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. (sic) [ 2025]. So the trial is on track. And with that, I hand the floor over to CFO, Dr. Ramzi Amri.

Thank you. Good morning, everyone. So for our financial update, we will give you the brief. As of June 30, the cash and equivalents totaled NOK 109 million rounded upwards with NOK 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. So 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's something you can already see in the cash burn in 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 2 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 II recruitment. Of course, more patients need more manufacturing activity. And you see also still a residual effect of the reverse merger and the fact that we are main-listed now in Oslo, 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. 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 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 e-mail 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 II study with the intent to prove with a randomized study that our belief in the safety and the 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. 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 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 products in our own site, basically from raw materials to shipment. Our pilot plant is one of our most relevant assets. It derisks the manufacturing massively. But at the same time, we want to be able to have redundancy in cross supplies. So we are looking to identify a CDMO probably in another region outside of Europe to be able to manufacture from 2 locations at the same time. And in order to make that efficient, we are, of course, looking at ways to automate and scale up our 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 the Phase III, but also make sure that there is a 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 III and you have a 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 time line 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 III trial with a significant uptick 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 Oystein 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.

Yes. It's a long list of questions. So starting from the top, I think we'll have to be selective. There's a long list of questions here. So the first question is that you stated that selective protocol amendments are improving recruitment -- which eligibility criteria were changed? And to what extent have these amendments increased clinical 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 have also allowed -- we have 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 yes, there are several questions related to recruitment status of the Phase II. And as we mentioned, recruitment is on track. And I think for the attentive reader of our material, you will see that we announced that we will have the most important interim readout at the end of 2027 or the second half of 2027, which is after 9 months follow-up. So that means that in order to have a last -- 9 months 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. 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 yes, as I mentioned, the main interim analysis, the 9-month interim analysis, I mentioned is when all patients have been 9 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. Yes, 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. So we have 10 today. We plan to add another 2 to 3 during the next half year. I mean, as I said, we -- this trial is now going towards the 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 II can be rolled over and hit the ground running, so to speak, in the Phase III. 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'll add a couple of more, maybe 3. Do you think you can answer that one?

Yes. 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 alpha radiation can treat cell clusters, including cells that have already started to grow into the peritoneal surface. That's 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's exactly what we can actually treat. Of course, the importance is timing. We do this after surgery because that's 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. And 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's an existing cluster, one that's still seeding. Of course, we are exploring options, but that's 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's the one we address.

Maybe take the next one as well, Ramzi.

Yes. So 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. So 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. So 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's 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. And 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. And 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 quarter 3? And the answer is not more than we actually stated. So 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.

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.

So you announced the acceptance of abstracts at ESGO and EANM or ESMO, I guess, and EANM at LinkedIn, but not through formal information channels. And we will do that when we are allowed to say more about the content. So then there will be a press release. But so far, we are -- we can notify the existence of it, but not about the content. So when they know the content or when they can tell you the content, we will through a press release. And now there's a question which may be a misunderstanding, but I will address it anyway. So what is the uniqueness of Oncoinvent Solutions? And are they the competition? And I believe there's a question whether Oncoinvent ASA and Oncoinvent Solutions are competitors. It's 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. And sort of on the same note, again, I would like to mention that -- and remind you that we did a reverse merger last year into BerGenBio. So 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. So 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 in the subpopulation based on an interim of the Phase III. If we launch it on time and recruit fast, it is possible to have that discussion by late '29, early 2030. And 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 Oystein 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 Oystein 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 authorization 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? And formally, the answer is yes and yes. I mean if the data is fantastic, of course, we'll talk to the regulators. But we expect and we guide that, of course, we need another trial in addition to the Phase II in order to get approval. But of course, the strength of the data will determine this. But not only the strength of the data, there's also a safety database that needs to be filled up with patients. So you need a minimum number of patients to ensure good safety. And I think that is the main reason why we believe that at least we will start -- we have to start recruiting into Phase III no matter how good the Phase II data is. Will the same hospitals participate in the Phase III trial? How many patients in Phase III, Ramzi?