Ladies, and gentlemen, welcome to this Second Half Year 2025 Presentation of Oncoinvent. My name is Øystein Soug. I'm the CEO of the company, in a few minutes, we will give you an overview of the highlights and the financials for the period. Before we do, and particularly for those of you who are new to the story, and those of you who need a refresher, I will give you a short introduction to the technology at the beginning. You can ask questions as we go along, that we will try to answer at the end of the session, and you will see on your screens that there's a button for asking questions. If you have questions, press on that button. This is the disclaimer for those of you who are interested in that.
Going to the introduction, the problem that we are aiming to solve in this company is cancer that has spread to the peritoneum or to the abdominal cavity, as it's also known. This is not really an indication per se, but it is a stage of disease that you will see in many different types of cancer. It is resulting from ovarian cancer, colorectal cancer, or various types of stomach cancers. It is a disease where we don't really have good treatment options for the patients today. In many other cancers, you will have immunotherapies or other modern medicines that really solve the problem for the patients, but this is not the case for peritoneal carcinomatosis.
What these patients will get is surgery. Surgery works to a certain extent. It will add maybe one to two years to the life expectancy of the patient. It's a good thing, and most patients will get it. No matter how good the surgery, there will be micrometastasis left in the peritoneum, in the abdominal cavity, that will cause the cancer to return. In most cases, this is actually what causes the death of the patient in the end. It's quite important to get control of these micrometastases. Our aim is to kill off these micrometastases and thereby prolong the life of the patient by preventing or delaying the onset of recurrence. That is our quest.
The insight that led to this, the invention of this technology, is the fact that the peritoneum is a closed compartment. It is like a sac, which is not meaningfully linked to other organs. This means that if you can create a drug, a radioactive drug, that stays in the peritoneum, does not escape, you can give high doses of radioactivity without harming healthy tissue. We are, with our clinical program today, trying to prove that. We're starting in ovarian cancer. Ovarian cancer for us is a good place to start because most of these patients, they will get recurrence.
When they get recurrence, they get recurrence in the peritoneum, in the abdominal cavity, and most of these patients, when they die, will die because of complications related to cancer in the peritoneum. It's very important to get local control for these patients in the abdominal cavity, and that is exactly what our technology is doing, and we believe that we have a solution to this problem. The FDA agrees with that, and they have given us a Fast Track for the development of ovarian cancer indication. The solution to our problem is Radspherin, the name of our drug candidate, which is radium-224, labeled on a microparticle made of calcium carbonate, or essentially, it's limestone. Radium-224 is an alpha emitter.
It is highly radioactive with a short range. We believe it's a good radioisotope. It has a half-life of 3.6 days, which means that it's fairly short. You will give a solid jolt of radiation in the beginning of the treatment, and approximately 75% of the energy will be released during the first week. After about a month, it's completely gone. It's fairly short, fairly intensive, but it's also long enough to enable eight day shelf life and centralized manufacturing, which is exactly what we are doing today. We're producing this ourselves in Oslo, in our pilot plant, and shipping it to sites in the phase II trial on both sides of the Atlantic. How does it work? The patient is in the hospital, recuperating after surgery.
She will spend maybe five to seven days in the hospital recuperating. On day two, she will get an injection of Radspherin in a liquid solution, approximately a quarter of a liter, through an indwelling catheter into the peritoneum. The indwelling catheter is left there by the surgeon two days before during surgery. The solution is then spread in the abdominal cavity, essentially reaching all the areas where there might be micrometastasis, killing it with radioactivity. It's essentially targeting by floating the peritoneum. Then you might ask, if you are killing all the cancer in that area with radioactivity, what happened to the healthy tissue, which is also in that part of the body?
The answer is that all the organs that are in the peritoneum, like the small intestines, they have a protective lining, which is thicker than the range of the alpha. Alpha travels only two to 10 cell diameters, and this protective lining tends to be thicker, so you just bump into it, and there's no harm done to the organs or the healthy tissue behind. Good. That's the technology. When it comes to 2025, it was a very active year for Oncoinvent, and particularly the second half. Most importantly, we reported the final positive data of our phase I trial in ovarian cancer. I'll show you the data in a second. We were happy with this data.
It was published in the prestigious peer-reviewed journal, Gynecological Oncology, and it is, as we speak, being presented at the ESGO European Gynecological Oncology Congress in Copenhagen, which started today. We're also running a phase II trial, which I alluded to. That trial has, by the end of 2025, recruited 26 patients. We're also running a program in colorectal cancer, where we, in the first half of the year, presented the final phase I/II data. It was presented as a congress, the PSOGI International Congress of Peritoneal Surface Malignancies, in the fall. A lot happened with Radspherin in the second half.
Also, on the corporate side, most importantly, we had a merger with the BerGenBio, and we also inherited the listing of BerGenBio on the Oslo Stock Exchange. We were previously listed on Euronext Growth. Now we're listed on the main board of Oslo Stock Exchange. I think also a side note here, it's important that for those of you who want to see the history of the share price, it actually only goes back to the first of November, because earlier than that, the share price you will see when you look at Oncoinvent ASA is not our share price. It's actually the share price of BerGenBio.
Anyway, on the heels of the merger, we raised NOK 130 million in equity, which means that we now have a cash balance of approximately $180 million. Last but not least, we also appointed Dr. Ramzi Amri as the CFO, and he's also with us today, and he will present the financials in a few minutes after my clinical update. You can see there are three trials in the clinical development plan. Two of them were presented in 2025, colorectal and ovarian cancer, and we are now in a phase II in ovarian cancer with a final readout in 2028, with approximately 110 patients.
In the ovarian cancer trial, the arrow on top here, where we had the final data last year, it's important to remember that the patients do not have cancer when they enter the trial. The only way for us to measure the success of or the efficacy of the drug is to wait for recurrence, to see when cancer returns to the patient, if at all. This is a small Phase I trial, we do not have more than one arm, we can compare with historical controls. Similar patients have received the standard of care in other trials. We see that after two years, approximately 55%-60% of the patients, they will have some sort of recurrence.
When we compare that to our trial, we will see that approximately 30% of our patients have some sort of recurrence, and what we are actually treating is the peritoneal recurrence. The recurrence in the abdominal cavity, we see that it is 10%. The 20% difference here are patients with lymph node recurrences, which are easy to treat and does not negatively affect the life expectancy of the patients. We think this is good data, and there is certainly some activity going on here. This has led us to, in parallel, to start a phase II trial in ovarian cancer, approximately 110 patients, where we're going after a fairly select part of the patient population. These are the patients that really do not have any other alternatives among the ovarian cancer patients.
They will get some neoadjuvant chemo before they enter the trial. They must be eligible for complete resection, meaning that there should not be any large lumps of cancer left after surgery. We also require them to be HRD negative, which means that they will not respond to PARP inhibitors, essentially making our trial shorter than it otherwise would have been. There was a safety run-in with six patients, and the rest of the patients, they will be randomized 2 : 1 with a control group of 1/3 of the patients. Primary endpoint will be progression-free survival, essentially a recurrence, and secondary endpoints include overall survival and time to various events. This trial is now running along, and as I mentioned, we have recruited 26 patients into this trial already.
10 hospitals are now active. It used to be six. Now we've added four more in Italy, U.K., and Spain, and we're already seeing the effect of adding these trials, so there's pretty good recruitment momentum so far in 2026. We see that we have already recruited substantially more patients in the first quarter of 2026 than in the fourth quarter of 2025. Things are ticking along nicely in that trial. Now, going forward here, we expect to see the effect of the additional trials. We will have additional sites. We will have one more hospital being added, so there will be a total of 11 going into 2026 further.... There are also selected protocol amendments, ironing out issues in the protocol that will smooth the recruitment even further.
I mentioned that we have strengthened the management team with our new CFO, Ramzi Amri. He's been with us for approximately a month now. He will have a traditional CFO role in the company, but also be responsible for business development. He is Dutch, and he comes from the Dutch Belgian large biotech company, Galapagos, where he was head of strategy and execution. Before then, he worked seven years at McKinsey, advising pharma companies, biotech companies, and financial institutions. He does not have the traditional background of a CFO. He's a trained medical doctor, and his education, he did partially in the Netherlands, but he also did his PhD research and postdoctoral work at Harvard Medical School and Mass General in Boston.
To present the finances, I'll give the word to Ramzi.
Well, thank you very much, Øystein, for the very warm handover. Very happy to join the company. I'm gonna put my best foot forward to make sure we deliver on our goals this year. Of course, this is an important point for the company to start scaling our phase II activities. I think the financials will be focused on what we delivered last year. I'll give you a brief summary on the situation as it was by year close. Also, good to know if you want to see any further details, of course, the annual report is available on our website, or I'm sorry, the second half year report. The annual report will be released in a few months. It'll give you a more detailed view on the current situation.
I'll give you the highlights for today. The most important thing is we will end the year with a post-merger cash position of NOK 180 million, which is a significant higher cash position than it was last year. A good result for us because it means we have a runway into 2027, which is beyond the phase II analysis we have planned for the phase II ovarian study. It gives us the flexibility to recruit patients in all the sites we mentioned and continue to push for as much recruitment as we can. Beyond that, I also think what you see in the numbers is that our operating loss is increased versus next last year or end of year 2024. This is mainly owing to the uptick in activity.
Of course, last year we were not yet started with the phase II study that we are currently running. Increasing the number of sites going from none to six to 10 to soon 11 means you need to scale proportionally in manufacturing, you need to scale into the support base, you need to scale CRO costs, and that's what reflected in the number. Another big part of the operating expenses for this year, which is a one-off, is the accounting effect of actually doing the reverse merger with BerGenBio ASA. Because we merged into a listed entity that has ceased its operating activities, there is an accounting rule where it counts as a reverse acquisition under IFRS 2. That means that any differences between the fair value of that company, needs to be subtracted from the fair value of the share issue.
That difference is expense as a one-off non-cash expense of, I think, NOK 21.6 million. That's something that will not return next year. It is also something that does not affect our cash position, but it is about a 20% or 18% of the total operating expenses for this year or for 2025. I think what we will see for the upcoming year is, of course, a continuation of those activities, and because of that, the intent is, of course, to have disciplined cash management as we go through the year. The one and only focus we have will be on the execution of the phase II trial and making sure recruitment happens in line with expectations or as fast as we can.
Of course, we have a good position in the sense that we have our cash flow forecasted to go into next year, but it also means we will have active efforts to prepare for any future financing and any strategic partnering that allows us to go beyond the phase II and look at the options into phase III. You'll read more about this also in our annual report. We'll also give a quarterly update fairly soon as well to give you more insights on what we have been performing this year. This is for now the most important figures. Again, please use the Q&A if you have any specific questions about these numbers or anything else that has been presented today. Otherwise, we will be happy to speak to you in the upcoming interactions that are listed here.
On April 22nd, we will release our annual report. That will be the fully audited figures for the whole year. We'll give all the necessary and appropriate disclosures, of course, on what we have done in the 2025 calendar year. On April 29th, we'll give you already our first update for this year. It will be a Q1 update and a presentation similar to this one. We will give you a bit more detail on how, what we've been doing in the first three months of the year. Our AGM is scheduled to take place on May 20th. You'll, of course, get an official release for that and a call when the official call comes out.
Beyond that, our next half annual report is set for August 27th, which will be in line with what we presented today. Beyond that, the third quarter will be bringing us an update on October 28th. Those will be the key things that we will speak to you about this year. For now, I will open the floor for questions, and Øystein will join me for those for the Q&A for today. Let's see.
Okay, we have several questions here relating to recruitment. Actually, most of them are relating to recruitment. I think I'll just lump them all into one question about how recruitment is going, and what we're doing about it. As I mentioned, there are 26 randomized patients in the trial at the end of the year. We've also stated in the report that recruitment has improved in 2026 over 2025, the rate of recruitment is increasing. The protocol amendments that we have done have an effect. The additional sites that we've included into the trial have an effect. We're seeing that recruitment is going better than it has been before.
we're not guiding on the completion of recruitment, other than that we expect to read out the final results in 2028.
On the guidance, we see a question about the guidance and doses optimization on the radiopharmaceuticals in clinical trials. It's an FDA guidance that was released last year. Does it have implications on our trial development? Yes and no. I think in general, it's important to have a good rationale for your dose. I think we are confident in our case that the dose is effective because we don't really have any dose-limiting toxicities that really put a hard ceiling on it. We are doing some long-term research on the dosimetry from the phase I colorectal and ovarian trials, which will help to get a better database, actually, to prove the effectiveness of the dose and the safety of the dose.
The other thing is, our dosing methodology is a bit simpler because we don't have any systemic effects that we have to measure. Of course, we'll do some organ measurements, but we will be following the guidance as is, and we will build a package that will clarify why the dose is apt and adequate.
Is there any demographic restrictions regarding recruitment? Is it possible that a study is going to have a wait for a region to reach full recruitment? The answer to that question is no. There's no regional mix that we're trying to reach in that trial.
Mm-hmm.
How many patients do you anticipate will be included in the upcoming interim analysis? We don't really have a number for that, now, but it's going to be the number of patients that will be included at the time when we do the analysis. Are you trying to find a partner for colorectal cancer? That's an interesting question. I think most biotech companies, they will always try to find partners, to spread the risk and get some help with the heavy lifting in the development of a drug, and, so do we, and we're also, looking for partners, not only with colorectal cancer but also for the whole technology to develop.
Mm.
This is something we are working quite actively with, as we should.
Correct.
Good. I think these are the questions that we are able to answer at this moment. With that, I'll thank you for the attention, and see you all next time. Thank you.