Ladies and gentlemen, welcome to this first quarter update from Oncoinvent. My name is Øystein Soug. I'm the CEO of the company. With me today we have Amri, who is the CFO. You can ask questions during our presentation. We will attempt to answer them towards the end to the best of our ability.
Also to remind you that according to our tradition, we will report numbers on the second quarter and the fourth quarter. During the first quarter and the third quarter, we will give a business update. There will be no P&L presented in this presentation. Let me first start with a brief reminder about who we are and what we do.
Oncoinvent is an alpha radiopharmaceutical company, based in Oslo, and the problem that we are attempting to solve is cancer that has spread to the abdominal cavity or peritoneal carcinomatosis, which is not really an indication per se, but it is a stage of disease that we see in many different cancers, for example, ovarian cancer, colorectal cancer, and various stomach cancers.
It's a bulky disease, and the cancer has to be removed, surgery is a mainstay in the treatment of these patients. It will add a couple of years to the life of the patients. No matter how good this surgery, very often there will be micrometastases left in the peritoneum, on the wall, in the peritoneal fluid of the patient.
These micrometastases and single cancer cells, they will often cause the cancer to return and in many cases also kill the patient. Our promise is to kill off the micrometastases and thereby prolong the life of the patient. The abdominal cavity, the peritoneum, lends itself well to radioactive treatment because it is a bit of a closed compartment. We can fill that with radioactivity. You can kill cancer cells without hurting healthy tissue. That is the quest that we are on. The way it works is that the patient is in the hospital recuperating after surgery, usually on day two.
We inject the patient with an indwelling catheter with our product, Radspherin, in the form of a liquid, which is then filling the peritoneum, sort of flooding the whole space, and thereby targeting the cancer cells that are left after surgery, and killing them with alpha radiation, which is very potent but so short that it will only kill the cancer cells and not hurt the healthy tissue in the region. That's this, not technology. That is our approach. Far, we have tested this out in two indications or actually it's the same disease, but it comes from two different sources, ovarian cancer and colorectal cancer.
Phase I in ovarian cancer and a phase I/II-A in colorectal cancer with good results, promising efficacy data, and absolutely stellar safety data, which has led us to start a phase II trial in ovarian cancer, where we also have FDA Fast Track designation. As you can see on this slide, that trial is ongoing as we speak, there's expected to be data readouts in 2026, 2027, and 2028.
Moving to the quarter. Now, the most important thing that we are doing in this company right now is conducting our phase II trial and recruiting patients into that phase II trial. So far, we have recruited 37 patients that are the ITT population, meaning the randomized patients, plus six patients we had in the safety cohort, in total 37.
Also in the quarter, we secured a new patent. It's a Chinese patent. With this patent, the protection for Radspherin in China is going to be deepened and broadened and adding to or complementing the existing composition of matter patent that we have in China. In terms of data, we did not report any new data during the first quarter.
We did that in the fourth quarter during 2025. In the first quarter, we published the data first in the journal Gynecologic Oncology, and we also presented the data at the ESGO Gynecologic Conference in Copenhagen in February. We also hired a new CFO in January, and that is Dr. Ramzi Amri. He's a medical doctor, educated in the Netherlands.
He has done research at Harvard University in the U.S. He spent seven years at McKinsey . We think that he's a very good fit for us as a company. I think now we are probably one of the few biotech companies in the world that actually has a CFO who has treated the patients that we're also treating in our trials. He will give us a few words about why he joined Oncoinvent.
As I mentioned, the phase II is important. We have 36 patients included in the trial at the moment as we speak. We see good momentum when it comes to recruitment at the moment. 2026 has been good. There are 10 hospitals in the trial recruiting at the moment. They're all recruiting.
Up until last year, at the end of last year, we had six hospitals recruiting patients, and we added four more in Italy, the U.K., and Spain. Going forward, we will aim to add more hospitals to the trial and thereby improve recruitment. I think also the most important thing that we have done is to do a few protocol tweaks.
In this trial, we've chosen a quite narrow patient population because we wanted to make sure that we chose exactly those patients that will have the best effect of the treatment. We're hesitant to change that patient population too much, but we have ironed out some wrinkles without affecting the purity of the patient population, which we are starting to see an effect of now.
All these changes are approved, the last one in April, and that we believe that it will have a positive effect going forward. Also, Possibia has an online tool that we have bought, which will optimize internet searches. It will help us recruit patients and help the patients to find the trial and also give the patients a pre-screener to see whether they qualify for the trial.
That might potentially also improve the recruitment into the trial. This is an overview of how many patients we have recruited in each quarter. As you can see, it goes a little bit up and down. That's just the nature of clinical trials. We also see that the first quarter in 2026 was the best quarter to date. At the current pace, the second quarter is also trending well. With that, I pass the ball to Ramzi, who will give us a few words about the cash situation and his situation. Thank you, Ramzi.
Thank you very much. Thanks everyone for joining. Of course, this is a general guiding. As we said, we don't release any official figures in the quarterly update. Overall, I think we are doing well on the financial side. Our current cash position as of end of March is amounting to about NOK 130 million in cash reserve, which is actually a spend that's slightly below what we expected. This means that our situation in terms of runway continues to be that we expect to run into 2027 with our current cash reserves. In terms of the outlook, this means that we continue to be able to finance our clinical R&D expenses.
As Øystein indicated, of course, if we recruit more patients, that will also increase the spend proportionally. That's of course something we accounted for. We might expect a slight decrease in burn that goes with that, but it is within the margins of what we have calculated, so there is no big changes there. We continue to be very committed to be disciplined in our spend. In general, I don't think there is any meaningful material change in the cash burn to be expected compared to either prior periods or what we expected at the start of the year.
Of course, in the meantime, we continue to explore actively strategic options to really extend the runway, and that could go through partnerships, business development, strategic collaborations, and any capital markets financing opportunities that come at the right moment with the appropriate setting and opportunity. That's basically where we are today. Now maybe for something a bit more unconventional.
As we, as we, I think, wrap the presentation part, just a brief note on why I joined. I'm a newbie here. I've been here for three months now. We get the question often, what brings someone with my not typical CFO background to become the CFO of a small biotech in Norway, having no prior links to the place.
The story will be a bit more obvious when I bring my background into it, and that's why I would like to share it with you. It begins with this picture. This was me, I think, over a decade ago. I honestly don't even know where this was or how old I was. I just know that I look a lot better rested, which is interesting considering where I was in my rotations back then. I did my senior rotations at the Netherlands Cancer Institute.
I've been tracking, monitoring, and working with patients at Massachusetts General in surgical oncology for about four to five years, mostly desk side, but also observing. I've seen peritoneal carcinomatosis in these patients. I have done HIPEC procedures or assisted with them. I've seen these patients bedside recovering.
Looking into this presentation today, I had a very humbling realization that all those patients that I have seen back then are probably no longer with us today. Maybe even more sobering, nothing about their treatment has changed since. The basic premise is still to operate on them, try to remove as much tumor bulk as possible.
You give them chemo, maybe you give them HIPEC if it's a center that supports it, but that's it. Now that's not a problem if the standard of care actually works. In this case, we know that the standard of care buys you months. If you're lucky, maybe a few years. The problem still subsists, and it's still a big issue for these patients. That's, I think, the fundamental premise of why I wanted to contribute to this story.
For me, the premise is simple. I know these patients. It's personal for me, more personal than the rest of the presentation, and I think it explains why I joined. I didn't just want to become the CFO of a biotech. That's something that wasn't necessarily my career path. I trained as a physician. I worked in surgical oncology. I did cancer research. But the idea for me is that I want to do something about this devastating disease, this peritoneal metastasis issue. It's one of those diagnoses where, once you see it, you immediately know this is serious, right? It's a real oh no moment.
I'm using mild words because it's 8:00 AM and we have a wide audience watching, but the words are a bit more powerful when you see this on the scan as a physician, and the feeling when you have to tell someone about this. The problem is you have to tell patients their prognosis is gonna be dismal. You know that you have to tell them that you'll try everything, but there will be a real risk of recurrence.
We also have to warn them that their quality of life will not be great, and that the path forward is going to be riddled with obstacles, with treatments that are very burdening on their life, with surgeries that make them recover for days, if not weeks on end, and will only recur over and over until the disease is inoperable and the patient is basically waiting for the end to come. In general, that's something that shows that there is a strong unmet need.
Why I think we are doing something right is that our product is actually designed to address that clinical failure point. That microscopic disease that Øystein mentioned is the problem, so small cells, cell clusters linger, grow back, and bring all sorts of trouble to the patients.
Currently we try our best to address that, but the data just shows that we don't have any sustainable ways to get rid of that. Local alpha therapy is perfect for that. It is very strong, very local. It doesn't even go through a sheet of paper, so it irradiates a field that we want to sterilize basically, but it doesn't harm any surrounding tissue. That is the perfect approach to get rid of residual disease that you cannot see while being comprehensive in an area that's really hard to cover otherwise.
The other thing is these cells are very advanced, very aggressive, and any chemotherapy-based product or any immune system modulating product has the risk of being escaped through the cancer cells. Alpha radiation destroys the DNA. There is no way for a cancer cell to avoid that.
That means this works for any cancer cell, including cancers that are not even mentioned at the beginning. If anything spreads to the peritoneum, this should in theory work. The other thing is as a clinician, you know that anything you wanna add to the standard of care is something of a threshold you need to get over.
With Radspherin, we only have to add a catheter during the surgery, and then during the recovery of the patient, you do a single procedure administered, which is a two-minute job, and you're done. That's the only addition. The patient barely notices anything from it. As far as we've seen, the side effects are very limited and it's pretty much impossible to find out whether any of the side effects we see are anything related to the surgery or not.
It is something that also doesn't affect their recovery or their overall quality of life. It's almost no regrets move to add to someone who is already recovering in the hospital and not doing much else. All of that makes sense. If you combine that with where we are as a team and as a company, this was a place where I think I can add value, but I think we as a group can add value to this patient need. The whole team that's working on this end to end has one goal, and it is to produce this and make sure it gets to as many patients as possible.
It's a really, really beautiful thing that at this company we do that end to end from the raw materials all the way to shipping it to the patient. After that, it's a matter of just giving it to the patient and hoping for the best where we do everything in between. I think I have the right combination of skills to help with that.
I have the medical background. I help with the strategy and help with the financial side. More importantly, I think I can help this company at a stage where execution is important, where finding financing and partnership is important, and we can shape the narrative to really explain why this is something that's important and can materially change the outcome.
That's in simple terms why I think the patient need is real, the product logic is clear, and this is a place where we can help translate a strong clinical rationale to a patient impact. That's in one nutshell why we joined the company. Short update, financial calendar for this year. Today's a Q1 update. We'll have our annual general meeting on May 20th. We'll have our first half year results, the H1 results, reports and presentation on the 27th. On the 28th October, we'll do our Q3 update. With that said, I would like to take time for questions, and Øystein will join me again. Welcome, Øystein.
Okay. I'll take the first and you can take the.
Yeah
... the second, Ramzi. We have only two questions so far, so it's still possible to pose the questions. The first question is, it was reported a significant increase in recruitment last company presentation. How would you say the updated ITT of 37 patients reflect this statement? What I said the last time was that we had significantly better recruitment in the first quarter than in the fourth quarter. It's. The numbers are four and 11. It's an increase. As I told you on the slide, it is a wobbly ride.
Sometimes you have a headwind and sometimes you have tailwind, but it seems to be that the trend is going in the right direction and that we are recruiting more patients than before, and we are still trending well. I think it looks good.
For the second question, I think someone is asking what the key qualities we are looking for in a partner and how those discussions are evolving. I think the key qualities is a good question. Of course, the basic need is someone who can help make sure we bring this into a pivotal study and approved, but that's not the quality we're looking for.
We're looking for someone who understands and believes in the product rationale. Ideally, someone who is familiar with the disease, with the mode of action, but also someone who is willing to truly partner with us. I think we have the expertise in manufacturing. We have the expertise with the patients.
If it's someone who can bring the product to market, faster with us, someone who is willing to float financial means or access to a specific market, that of course helps. That's why we're doing this across BD, across strategics, and across financing. If it's an investor, ideally it's someone who can, who can look into the long-term value and bring this to approval with us. Maybe that's tranche financing, maybe that's a, you know, a layer of financing for other partners. It could be licensing in a specific region that could make it possible for us to bring this further into clinical studies.
Of course, since the product is valid for multiple indications, it could be that someone who specialize in one of the subcancer types and really focuses on that. The discussions are going well. I think we're talking with partners potentially in Asia, in the United States, in Europe. We're talking also to investors in both continents.
We have some advanced conversations I think on the strategic partnership side. Of course, we will update the market whenever something material comes up. We are actively working on it, and this is the year where we need to do that. Of course, our hope is to get into pivotal study either next year or the year after. It's a critical time to do that, and of course, we are open to conversations.
This question about who randomizes the patients, the local hospital or Oncoinvent. The answer to that question, it's actually a computer algorithm that does it for us. There's no criteria, there's no human impact on the randomization. A question, could you elaborate on patterns or dynamics you see among hospitals recruiting well? I don't think it's an easy answer to that question. I think what is a common denominator among the hospital does that recruit well is that they have very committed and energetic PIs working there.
Mm-hmm.
... of course, you need a champion. You need someone who cares and someone who believes in the program and goes the extra mile. I guess that's the difference. They're all recruiting, there are no big differences between the hospitals.
Right. I see there's also a question on the timing for a partner agreement. When is the timing right? I think, we have runway into 2027. In general, I do think anything from now to end of year is good timing. Depending on how fast recruitment goes, I don't think, the current phase II is well funded.
We think the best timing is whenever someone wants to take the leap of faith and wants to take a long-term collaboration with us for that pivotal study. I think a partner could also realize that we can invest in specific, development activities on the CMC side or on the scale-up side of the manufacturing in other continents.
The sooner we do that, the faster the trial can start recruiting, and also the faster it will be at the beginning because our capacity will increase. The timing to me, it begins from today. That's why we're actively looking for partners. It also depends on what the partner is looking for. If it's licensing the product, you can do that right now. Of course, in our case, we will look for partners that will license it specifically in a region. It also depends on what the commitment is on the other side of that licensing agreement.
There's another question here. Is there a positive sentiment with the patients around the combination treatment versus HIPEC?
Mm-hmm.
Are the doctors positive to this experimental treatment? Do you get any headwind in the professional environment giving this as a radioactive particle? I will answer the last question here.
Mm-hmm.
... is a very clear no. There's really much less concern about radioactivity with the, especially with patients and hospitals and the operating physicians than you might expect. This is by now standard. Nobody is really worried about radioactivity, as it maybe was 15 or 20 years ago.
Yeah. On the combination with HIPEC, that is I think a complex situation, but the answer is relatively simple. The complexity is in the fact that HIPEC in colorectal is widely adopted at the centers that actually do and have the expertise to do HIPEC. We have seen in a colorectal data that the standard of care, including HIPEC, still is benefiting massively from adding Radspherin.
If you remember, the phase I/II- A data shows that the recurrence rates are pretty much cut in half in a group that already gets HIPEC. The rationale in colorectal is strong to believe that this is an important adjuvant to a group that has a very high risk of recurrence. In ovarian, the field is a bit more split, and the debate is open.
There's multiple publications, significant conversation during academic meetings on whether or not HIPEC should be standard of care. In our current phase II, we are not including HIPEC at the time of the study startup. Still today, I think the majority of centers and the majority of patients do not get HIPEC.
If we were to include it, you would have to do a subset analysis, which would drastically increase the cohort size we need to find any real statistical signal. In the future, of course, basing on how the field evolves, we of course will consider whether or not we should at least add HIPEC to a pivotal setup. I don't think anyone is doubting that Radspherin and HIPEC are not complementary. It's a different mode of approach.
As I said in my earlier presentation, HIPEC is still dependent on chemo sensitivity. We are not, a lot of patients will at some point get insensitive to whatever you give during HIPEC. Even if there were any competition, we would still be a last line of defense for these patients. We think they're complementary and adjuvant, I think most physicians and KOLs agree with that. We see no difference, for instance, in traction from the PI perspective, based on whether or not they prefer HIPEC.
Good. That was the last question. Thank you for following, this production, and, see you the next time. Thank you.
Thank you.