Good morning, everyone. Welcome to Oncoinvent's Q3 presentation. Today is October 28th, 2026. I am Ramzi Amri, I am the CFO of the company, and I would like to talk you through today's presentation and our participants. With me today is Øystein Soug, our CEO, who will take the word as the last speaker. We have a new addition to the team, Zuzana Jiráková, who is our Chief Medical Officer and who will introduce herself in the middle of today's presentation.
Warm welcome to her on behalf of everyone at the team. I hope you will get to meet her today and understand a bit more her background and why she joins the team. As you all know, this is a webcast. The webcast is recorded. You will be able to find it on the website. You can also follow the link that was in the press release to watch it back.
We have a Q&A function available to you. You have the link on the webcast as well. You can submit questions from now on. We will take ample time at the end of this presentation to answer your questions as much and as far as we can. I would like, of course, to also point you towards our disclaimer and our forward-looking statements.
When it comes to the content today, we will have three main parts. I will cover the highlights and the operational updates for this quarter. Our new CMO will introduce herself and tell you a bit more about her background and her reasons for joining.
Øystein will talk you through the opportunity and the value proposition of our program and how we are preparing for our phase III, which is a bit of a follow-up of what we discussed in our half-year presentation, and you have seen probably in the news and the updates following the private placement. We think it is worthwhile to give you a bit more background on what we are working on right now.
To begin with the facts, I think we continue to have a very good momentum in our current operations. By the end of Q3, we have recruited 71 patients, which is about 2/3 of the total population, if you include the ITT set plus the safety set. We are now at 11 clinical sites. We have added one more site in the third quarter, which is the Hospital of Saint Luc in Brussels.
In this quarter, we also published a dosimetry paper in the Journal of Nuclear Medicine, which is, I think, one of the higher-ranked nuclear medicine journals in terms of impact factor. We also presented three different abstracts at ESMO and EANM. You can find more details on the respective websites, and you have seen probably our press releases on this.
On the corporate level, followers of the company will know that we completed a private placement and a retail offering in late September, which raised the gross proceeds of NOK 148.5 million. We will discuss the purpose and the setup and the background in a bit more detail. Of course, feel free to ask any questions if you have any. Of course, we just announced this morning the appointment of Dr. Jiráková as our CMO. Those are, I think, the main highlights for this period.
When we set this against the 2026 priorities as we outlined them earlier in the year, we are still very much on track, and we deliver on the key priorities. We really built up the momentum in the phase II recruitment, and we continue to hold good momentum. You will see a bit more on the details later on. We passed the halfway mark in the summer. We are at 2/3 now, and we can already say that Q3 is pretty much on par with Q2 as by far the best quarter so far.
We see similar momentum in Q4, so we are delivering on that, and we continue to be optimistic. The clinical site network has been extended significantly. We have added five sites this year so far, so we are near double. We continue to look for more sites.
Reason being that we assume that these sites will also be ready to join us in the phase III in EMA countries usually allow a rollover of the sites at the phase III, so it allows us to hit the ground running in the phase III. We cleared several protocol amendments earlier this year, which allows us to actually lower the threshold for patients to be included, and that is one of the key drivers in allowing us to recruit faster and have more patients included and get our product as a life-saving measure for them, hopefully.
Cash burn is important. You remember when I joined earlier this year that we made it a priority to be conscious of the cash burn. We were in a luxury situation when it came to recruitment, but we managed to keep the burn very modest compared to the level of activity we have.
We spent around NOK 110 million by end of Q3, which is in the low teens per month, which is no significant increase versus our baseline early in the year. Which meaning that we continue to have a stable cash burn despite doing significantly more with the cash in terms of patient recruitment. That is, I think the best scores we can have right now expecially with the phase III preparations ongoing.
Speaking of, I think that our fifth and key priority is to prepare the ground for that phase III. This private placement is crucial for that and is one of the key reasons we had to do this. It allows us to prepare for that in more, I would say, proactive way than waiting for data and then having to start everything up only then.
It allows us also to make sure that we de-risk and scale up our manufacturing, b ut we will touch on that in a bit more detail, and Øystein will give you a bit more details on what we intend to do with our additional funding in the last part of this presentation. On recruitment, as you see, we are having a good year.
As I said before, 71 patients so far, but also worth noting, 44 until end of Q3 means that we recruited more than twice the number of patients that we recruited in the similar timeframe last year, and almost double what the full year did in 2025. Q3 recruitment was good. I would say week for week, it is a very good number even compared to Q2, for two reasons. Q3 is the summer.
Generally speaking, in recruitment, you see that the summer is a period with the recruitment usually taking a bit of a hit as the activity in hospitals goes down. We also had two weeks of regular scheduled maintenance at our site where we actually have the manufacturing being ready for the next year. Two weeks without recruitment, still being so close to the Q2 number is really good.
Also worth noting that Q4 right now is also trending similarly and continues to show promising pace of recruitment. We expect this to continue more or less at the same pace for the rest of the year. All of this is, of course, bolstered by the fact that we have now 11 sites active and actively recruiting. As we said, we will continue to see if there is opportunities to add sites.
Most of it will probably benefit in the phase III study. Of course, the more sites we get involved, the better. Briefly on the raise, more details later. As we said, we raised in a private placement with an overnight book build of NOK 148.5 million. It was also including a retail tranche. What we managed to do with that extended runway into the second half of 2027.
Our cash position today is NOK 200 million as of end September. We have a comfortable margin to set things up for the phase III, reach that efficacy readout that we are planning now for March, April, with the benefit of having more than twice as many patients in that readout, and with a significant nine-month follow-up.
The total number of patients will be close to the full cohort as well, so it is a much more representative and a much more meaningful readout than anything we do before when it comes to the efficacy side. That doesn't mean that the December readout on safety is not meaningful, but Øystein will touch a bit on that later.
What we will do with these proceeds is, I think, three main things. One is to really complete that phase II, complete the recruitment, progress the study beyond that interim readout in April with nearly all patients recruited. At the same time, we will talk to regulators and get ready for the phase III.
We will talk to FDA, we will talk to EMA for the CMC and the clinical parts and make sure that once the data is in, we would be able to move for IND and CTA for the phase III as fast as is reasonable, and therefore gaining a bit of time on a more linear path. At the same time, internally, we will work on scaling up our manufacturing.
We will work on de-risking it by having a second manufacturing location through a CDMO, most likely in the United States, and we will be ready for early start-up activities that don't have to rely on the efficacy data. That is engagement with CROs, engagement with clinical sites, all of it so that once we can actually get started, we can do it as fast as we can.
The last part that is important, and that is something that touches on why we do these types of placements, is we need to have options beyond the data, and we have to have runway where we can actually explore options. It is going to be important to fund that phase III. Obviously, this is not an amount that will allow us to run a full phase III study.
That means, again, the opportunity to raise equity. It could also mean to work with strategic partners or partners in pharma. We continue to do BD efforts that could fund some of the trial, b ut the important thing here is to time your move as well and have the time to make the right choice for us, for the patients, and of course, for your shareholders that allow us to capture value while keeping your interests in mind.
Having that runway beyond the efficacy readout is going to help us massively with that. That is going to be our strategy for next year, and it continues to be that we continue to look at options all the time, and we jump on them opportunistically when we can, provided the opportunity is actually worthwhile. That is it from my side for the operational update. I will now give the floor to our new CMO, Zuzana, and I would welcome you again.
Thank you, Ramzi, for kind words and introduction. Good morning, everyone. I am very happy to be here, and I start my introduction with a photo. What you do not see on this photo is that I am a passionate drug developer, and I have spent the last 20 + years learning and gaining experience in various roles and different companies, and I am happy to bring it here to Oncoinvent to help develop Radspherin in ovarian cancer and beyond.
Before I tell you a little bit more about why I decided to join Oncoinvent, let me set the stage, telling you a little bit about ovarian cancer. Most women with advanced ovarian cancer who undergo surgery leave the surgical room without any visible disease. Yet up to eight in 10 of them relapse. What is the cause? It is no visible disease.
Mostly the peritoneal micrometastasis, which drive the relapse in ovarian cancer. Let me ask a question. What if no visible disease could finally mean no disease? Let me give you the three main reasons why I joined Oncoinvent. I continue with ovarian cancer, which is our lead indication. It still is one of the deadliest gynecological cancers. Survival, despite of advances in various treatments, remains modest for ovarian cancer.
Of course, a topic close to my heart, women's health remains still one of the largest white spaces in healthcare innovation. Why Radspherin? I already talked about many failed therapeutic approaches in ovarian cancer. Also, the fact that a drug developed or discovered in 1960s, platinum, is still the backbone of first-line care in ovarian cancer.
When I looked at Radspherin and what Oncoinvent is doing, I believe it is designed to act exactly when and where it matters for ovarian cancer patients. Why me? What do I bring to Oncoinvent? I already told you that I have spent 20 years learning, and it's spent across strategic, medical, operational, and regulatory aspects of development.
I also bring phase III and alpha emitter experience, and I am also committed to patient-centric innovation. Those are busy and exciting times for Oncoinvent, and I look forward to bring Radspherin forward to patients together with the Oncoinvent team. With that, thank you for attention, and I hand it over to Øystein.
Thank you, Zuzana, and welcome to the team. You're certainly joining at a very exciting time for Oncoinvent. I suspect that most of the people on this call know what we do at Oncoinvent, but I will nevertheless take one step back. The problem that we are aiming to solve at Oncoinvent is cancer in the abdominal cavity or the peritoneum or "bukhulen" in Norwegian, which is an area of a very large unmet need. There are very few options today for these patients other than surgery.
Please remember that over the last 20 - 30 years, there's been a revolution in the way that we treat cancer patients. They're symbolized by therapies like targeted therapies, immunotherapies, ADCs, personalized medicine, and radioligand therapies that are coming onto the market over the last 20 - 30 years, b ut this revolution has not reached all types of cancer.
Historically, cancer in the brain or the pancreas or cancer in the abdominal cavity has been left out. The reason for this is pretty clear, at least in the case of the abdominal cavity. These revolutionary drugs that I mentioned, they are all systemic. It means that they are injected into the bloodstream of the patient, and they have some sort of targeting mechanism that seeks up the cancer, does something to it, or kills it.
C ancer in the peritoneum, however, they're not well vascularized, meaning that blood supply to the tumors are not very effective. You cannot really deliver drugs through the blood to cancer in the peritoneum. Systemic approaches, they simply do not work well. Obviously, our approach is different. After surgery, we are filling the abdominal cavity with a radioactive fluid that stays active for a couple of weeks.
We are eradicating micrometastases, single cancer cells, and small nodules that are too small to be detected by the surgeon or otherwise left after surgery. We are preventing recurrence of the cancer and thereby prolonging the life of the patient. Our approach seemed to be working. We had two trials that read out last year in cancers that metastasize to the peritoneum from ovarian cancer and colorectal cancer.
We showed encouraging signs of efficacy and a great safety profile, which led us to start a randomized phase II in ovarian cancer with more than 100 patients, which Ramzi just talked about, and is ticking along nicely. As you can see here, we're also planning for three readouts in the medium term. There's an interim safety readout before Christmas.
There's going to be the first interim efficacy readout in April next year, and a second interim readout with all the patients have been in the trial for nine months. The exact timing of which, of course, depends on the recruitment, but it could be as early as late 2027. We are ramping up for the phase III in ovarian cancer, and if everything goes right and according to plan here as well, we may be able to start that trial as early as next year.
This is the trial design of the ongoing phase II trial. As you can see, it's a little bit more than 100 patients that we're planning to recruit here, randomized two to one , standard of care versus standard of care plus Radspherin. The patients do not have cancer when they enter the trials.
We have to wait for recurrence, and we will do imaging scans every three months for a total of 24 months in order to see the difference between these two groups in terms of recurrence. The primary endpoint is progression-free survival, waiting for the cancer to return. In the near term, we will have two interim readouts, the safety before Christmas and efficacy in the spring.
Important to remember here is that our patients are entering trial without cancer, as I said, but we have to wait for the cancer to return, and that will take some time. After nine months, we expect there to be some difference between the Radspherin arm and the control arm. That's the minimum of time that we have to wait to see a meaningful effect. Safety events, they tend to occur earlier.
These we can read out without waiting, and we do this before Christmas this year. As you know, safety is important in all cancer treatment, and particularly in radiopharmaceuticals. We believe that this randomized data in at least 75 patients is going to be a meaningful readout, an important readout for us towards the end of this year. If we wanted to, we could also have read out efficacy this year, but by letting the data mature a few more months, we get more patients in the bank, obviously.
Even more importantly, we double the number of patients that have been in the trial for nine months or more. Simply put, what we get in April is a larger and more mature data set that de-risks the readout. That's the reason why we're doing it this way.
Looking ahead, as Ramzi already mentioned, we are planning for the next steps. The interim analysis that we're planning, they will inform the decision to advance Radspherin to phase III, obviously. Preparations are already underway so that a positive readout can translate quickly into a phase III start. We are getting ready with the trial design. We're taking those plans to regulators on both sides of the Atlantic, and of course, we're also getting manufacturing ready and scaling up for the phase III.
Like any sensible biotech company, getting ready for a partner to validate the technology and also to take part in the future development. Before we go to the Q&A, we'll take a look at the upcoming meetings that we're planning to go to, BIO-Europe in Germany, now in November. There's a Jefferies week in London where we're going.
DNB has their healthcare conference also in November, and there is a TRP, Targeted Radiopharmaceutical, conference in London in December. Then JP Morgan, where we will participate in Biotech Showcase and BIO Partnering during that week. But of course, the easiest way to get in touch with us is not to travel to San Francisco, but to send us an email. Good. So, I will ask Ramzi to get back in the screen.
Thank you for summoning me.
Let us see if we have some questions.
Yes.
Let us see, how can we-
Start from the top.
Following the very low and encouraging 18-24 months cancer recurrence rate in patients with peritoneal cancer, I believe it would be of interest to know whether any additional follow-up data are now available, given that another year has passed. If so, what are the latest results?
That's a very good point. For the ovarian study, we per protocol follow them up for two years, 24 months. That's what the final data is based on, b ut the good news is we also have the opportunity to follow up for survival for up to five years. Now, of course, that means you need to actively do a snapshot, as we say, and that requires some procedures. So there is the option to look at their survival data.
I think that's absolutely relevant to look into, and it's something we will do, I think, in the foreseeable future, I would say. Exactly for this reason. I think the data has been promising, and survival data is also important as a proof that we don't just prevent recurrence, but we actually improve the long-term outcomes for these patients. I'm not saying something is coming in the short term. This needs some work, but we will absolutely look into updated survival data in due course.
Yeah. There is a long question about the timing of the various data points that I just talked about. That question probably came in before I discussed it. Just to reiterate, we are planning to do a safety readout before Christmas. The efficacy readout is then coming in April. The main reason why we changed the date of the efficacy readout is to let the data mature a bit more.
Again, the patients with nine months follow-up are the ones that matter most. Here you can see in December, 20 patients would have had nine months follow-up, but in April, the number would be around 40. That is a doubling of the relevant universe. What I am showing here is a snapshot of the standard of care group and what it could look like for a December analysis.
We know quite a bit about these control patients. We can forecast a recurrence based on historical evidence, and this is what it would look like. Some of these patients will have been included only recently. The most relevant are the ones inside the box, the ones that have been in the trial for nine months or more. We show only the control group here, because this is essentially the data that we have to beat with Radspherin.
Obviously, over time, these patients will experience progression, and that is symbolized here with the pink and red dots as an estimate for when the recurrence is going to happen. As you can see, for a December readout and then December analysis, approximately seven patients will have been in the trial for nine months.
Statistically, we would expect two to five of them to have relapsed. That is the limited data set, and plus or minus one patient could change the interpretation. If we look at the data set in April, since we are going to let it mature until April, you see that the number of relevant patients pretty much doubles from seven to 13, and the data becomes more solid, more mature, and the probability of getting a truly meaningful and valuable outcome from the interim analysis increases significantly.
In terms of the equity raise that Ramzi talked about and the use of proceeds, it actually would have been a pity not to let the data mature when we had the possibility to do so. That is the answer to that question. Next question, when do you plan the end of phase II meeting with the FDA and EMA, and what phase III design are you discussing?
Yeah. As you know, I would recommend anyone who has questions about the phase III design to take a look at the company presentation we uploaded following the private placement because there's quite some detail there. One of the approaches we had is actually have a sort of end of phase II discussion before the phase II ends with the FDA this year, and we are discussing the study design already there.
While we have the option to do an end of phase II, and we might do it, we will not gate the timelines on that meeting taking place. In our upcoming FDA meeting, we already discussed these things. As a matter of public record, we are trying to get peritoneal disease free survival as an endpoint.
But we do know based on previous trials that PFS or progression-free survival will very likely be something that's accepted. The population is broadly saying all the ovarian cancer patients, HRD negative and positive, with the exclusion of BRCA-mutated patients. The size currently, because we don't have any real-life data on the PFS, is assumed to be about 500 - 600 patients, and the comparator is, as is stated, I think in a question, standard of care.
Whether we include HIPEC or not is something we're actually discussing with the FDA, and we want to wait on that choice until the moment where we are ready to submit, because it's an evolving situation, and it depends really on the adoption rates of HIPEC, whether it's actually useful to include these patients or whether it might slow us down. The better we know which choice to make, the more valid it is, and we don't have any reasons to pin ourselves down to either now. It's something we'll wait for in the nearby future.
Next question. How many patients do you expect to be included in the safety readout in December? We're saying 75+ . It could of course be also a bit higher, where the cutoff is going to be somewhere between now and Christmas. The average follow-up for these patients will probably be in the area of 18 months.
Yeah. I think the median will be a bit lower, of course, because we have a lot of new patients. I think the maximum is going to be 18 months, and we have a lot of recent patients, so the median is going to be somewhere between six to eight months, b ut for safety, of course, as I think you already mentioned, a lot of the safety events happen close to the initial surgery. So for most of these patients, the follow-up is meaningful enough that we can actually look into safety signals.
Is there potential in the future to explore maintenance dosing of Radspherin to possibly even further extend the RFS? I think to answer that question, maintenance dosing of Radspherin in the peritoneum, the way we dose it probably is not the first idea. I think for Radspherin to work in the peritoneum, it has to be close to or right after surgery.
O ne idea is, of course, to explore maintenance in the sense that you use it also after a second surgery, because some of these patients, they do get a second surgery. So that is certainly something that we are looking into. Next question. Could you provide an indication on recruitment progress so far in Q4? As Ramzi already said, it is tracking nicely. So we don't see any worries in the fourth quarter. The last question we have so far relates to the phase III design. That's probably a comment to the deck after the-
Yeah.
... after the raise.
Yes.
Not the quarter, b ut the question is, you plan to have more than 500 patients in the phase III. Why do you need so many patients?
There is-
It's a matter of statistics, but-
Yes.
... why don't you give it a shot?
Yeah. I will not bore you with a statistical lecture here, but it's a combination of multiple things. First off, we need sufficient patients to prove safety. We are a product that does things very differently from others, so regulators will tend towards conservatism, so more safety data, the better. Even though we do think we have a good profile, and we think the interim will prove that, you need a certain number of patients to show significant differences.
The other thing is we are aiming for a broad label. It's pretty much everyone in ovarian cancer except for the subpopulation with very good survival and good response to PARP inhibitors. The third thing is we have, of course, a drug that has to prove absence of disease, which takes time, and with a broader population, you can read that signal out faster.
A smaller set would have to wait longer, which on a cost perspective, but also on a timeline perspective, would hurt us. The other thing I'd like to flag is we don't know exactly what our drug has in terms of efficacy today. We are just as blind to the data as you are. If, of course, the efficacy is much better, it could mean that the population would be slightly smaller.
But realistically speaking, the design needs to account for a certain number, and that number is now pinned on what we think is realistic. We have the ability and the freedom to actually change that number as we get close to filing once we know the randomized data. So it could change, of course.
Good. This is already a long quarterly presentation. I think we'll stop there, and thank you for the questions, and thank you for listening. We will get back with a full-year report or second half report in the first quarter of next year. See you then. Thank you.