Good morning to everyone watching live, and hello to those of you who watch this recording of Oncoinvent's First Half Report 2025. Today is the 27th of August. My name is Øystein Soug. I'm the CEO of Oncoinvent, and with me today, I have Tore Kvam, the CFO. During the session, you can ask questions. There's a box in the lower right-hand corner where you can ask your questions, and we will strive to answer them towards the end of the presentation. This is the disclaimer. The agenda today: we'll go through highlights, clinical update, we'll say a few words about the merger with BerGenBio, and of course, the financials and upcoming milestones. This is a half-yearly update, and we assume that most of you are somewhat familiar with our business. For those of you who are new to the story and those of you who need a refresher, this slide will give you the essentials. We are an oncology biotech company listed at Euronext Growth in Oslo. Our drug candidate is called Radspherin, which is a radioactive alpha emitter that we use against cancer in the peritoneum or the abdominal cavity, or bukhulen in Norwegian. It has a clever yet simple mechanism of action, which allows us to treat all cancers in the abdominal cavity, no matter its origin. The cancer can start there, or it can come as a metastasis from somewhere else. Radspherin has already shown great results in early stages in two indications, which has led us to start a phase II trial in patients with cancer in the peritoneum resulting from ovarian cancer. This is an area with an enormous unmet need. There's really nothing there for these patients, and there's also limited competition. Radspherin is one administration only, easy to use, and slots very well onto the standard of care which is being used today. In addition, when it comes to the team, it already has a track record. We share founders with Algerta and ARTBIO. Being located in Oslo, we have recycled many of the specialists, the managers, and the board members from the Algerta days into senior roles at Oncoinvent. The highlights in the period were many and important. Ovarian cancer is our key focus. We have two trials ongoing: a phase I trial and a phase II trial. In the phase II trial, we confirmed a durable benefit in an interim 18 months data readout. That's not final data. It's an interim data readout. Late last year, we started the phase II trial with a safety leading cohort of six patients that read out earlier this year and allowed us to open the randomized part of the trial, meaning the part of the trial that has two arms. That trial is on track. In order to secure the recruitment and maximize the recruitment of patients into that trial, we are in the process of adding on new trial sites to the trial. Today, we have six hospitals recruiting patients, and we're aiming to increase that maybe by the double. Colorectal cancer read out positive final data from a phase I/II-A trial that I'll present to you in a minute. On the corporate side, importantly, we improved the financial discipline. We reduced the operating expenses by 28% versus the same period last year without reducing the activity of the company. We also announced a merger with BerGenBio, and we are very proud to have been chosen by BerGenBio as their preferred merger partner. This merger will create a combined new company with a solid shareholder base and Oslo main listing, a promising clinical candidate, solid financials, and cash runway beyond the first phase II data in 2026. This is underpinned not only by BerGenBio and the merger, but also by a fully guaranteed NOK 130 million financing round that will take place in October, and that Tore will tell you about a bit later in the presentation. This is our clinical development plan with three trials. We have an early program in cancer that has spread to the peritoneum from two indications, ovarian and colorectal, and an ongoing phase II trial in ovarian cancer. The green stars here indicate the data readouts, and you can see that there have been several in the first half of 2025. First, we'll take a look at the colorectal cancer readout. This trial is a phase I/II-A and had its final data readout in June this year. The trial recruited a total of 47 patients in Uppsala and Oslo, of which 36 received the recommended top dose. These patients received Radspherin right after surgery, and it's a big surgery that these patients get when they take out all the cancer in the abdominal cavity. What we measure here is the time to recurrence. Does the cancer return, and if yes, how long does it take for it to return? This is a single arm trial, which means that we compare with similar trials where the best standard of care has been given to similar patients in similar settings, so-called historical control. The patients were followed for 18 months, and the final data relate to the 36 patients with the top dose at the end of the trial. What we see here is that the patients who received Radspherin experienced a marked improvement compared to the expected outcome with standard of care. We see a 28% versus approximately 50% in historical control. This is great data, and it has been accepted by PSOGI, which is the Peritoneal Surface Oncology Group International Conference in October. We're very proud to be presenting there. This is a specialized high-caliber gathering recognized as the premier event in this field. It's well attended and scientifically influential. We're really looking forward to that. Why is this data important for the patients? Patients with colorectal cancer tend to get metastases in several organs, predominantly in liver and lung, in addition to the peritoneum. As shown here, one third get peritoneal metastases only, while two thirds get a mixed collection of metastases. What's important here, however, is that whereas we have good treatment options for distant metastases, like liver and lung metastases, there are only a few and really no good options other than surgery for the peritoneal metastases. As soon as the colorectal cancer patient gets peritoneal metastases added to the mix, a life expectancy is cut in half, as you can see here, and the five-year survival falls from 50% to under 20%. This means that controlling the peritoneal disease, the peritoneal part of the disease of the cancer, which is actually what Radspherin does, may significantly improve the survival of colorectal cancer patients. That's why it's important data. We also reported ovarian cancer interim data this year. This is a phase I trial. The trial recruited a total of 21 patients, of which 10 received the top recommended dose. As with colorectal cancer, these patients received Radspherin right after surgery, with the patients then free of cancer. What we are measuring is the time to recurrence. Also, single arm, comparing with best standard of care in historical controls. Again, what we see here is that the patients who received Radspherin experience a marked improvement compared to expected outcome with standard of care. We see 10% versus approximately 40% in historical control. These two data sets together, of course, they're relatively small, but they support each other. They both point in the same direction, and the magnitude of improvement in the two indications here are very similar. We feel that the indication of efficacy that we have produced by showing this data is stronger than merely the sum of the parts, and it supports the mechanism of action of Radspherin. This is not final data. It's 18 months interim data, and the final data will come later this year. Colorectal 18 months and ovarian 18 months are behind us. Looking at the future, in addition to the ovarian 24 months data that I just mentioned, the next big data point for us will be the first phase II data in late 2026, namely nine months interim data on patients that are available for analysis at that time. Needless to say, that'll be a significant data point for the company. It is the first time that we show randomized data. Importantly, also, the funds that we're raising now with BerGenBio and the rights issue secure a cash runway beyond this data readout. Patient recruitment in this trial is on track. As I mentioned, we have six hospitals. They are all actively recruiting patients. The rate of recruitment picked up in May and June, and now we have a total of 14 out of the 96 patients, including safety, included into the trials. We believe that the rate will pick up during the fall by increasing the number of hospitals participating and recruiting into the trial. Also, there might be some changes to the protocol to ease their recruitment. That is probably not coming early in the half year, but later towards Christmas. That will also strengthen recruitment going forward. Now, a few words about the merger with BerGenBio. The rationale for this transaction is not operational, but rather financial. BerGenBio has a main board listing at the Oslo and a large and solid shareholder base. All of this is very attractive to Oncoinvent, obviously. The BerGenBio board chose to merge with Oncoinvent since we have a promising drug candidate in phase II. We realize that that is not enough, and we will work hard to serve the trust of these new shareholders going forward. Moreover, the rationale for this trial was to raise more money on the heels of the transaction with BerGenBio. In total, together with fundraising, we raised NOK 175 million, which is a process we're in the middle of right now. Tore will say a few more words about that transaction in a few seconds. It's an all-share transaction. There's no money changing hands. The new combined company will fall to 25% ownership of the old BerGenBio shareholders and 75% to the old Oncoinvent shareholders. BerGenBio will actually be the surviving entity, meaning that going forward, we will merge into BerGenBio, but it will change name to Oncoinvent ASA. The transaction is supported by both boards and was actually approved already by both AGMs earlier in August. There will be financing subsequent to the merger in October, which is 100% underwritten already. There's no excitement around that in terms of the risk of it going through. That is 100% guaranteed. To take you through the timelines of these transactions and also the finances, I give the word to CFO Tore Kvam. Tore. Thank you. As we've been receiving some questions about what is the timeline and some confusion about it, we decided to impose the preliminary timelines that we are working towards internally. Having said that, these can be subject to changes. These are dates on or about, so there may be changes to those. What we're looking at now, we expect to have the formal approval of the merger towards the end of September, with a subscription period of the transaction of the rights issue in mid-October and a final closing of the rights issue towards the end of October, beginning of November. That's kind of the broad picture. This is a rights issue, which means that the shareholders of Oncoinvent and BerGenBio will receive tradable subscription rights, which will give them the possibility to participate on equal terms. We've also been receiving some questions when it comes to pricing. What will the pricing be of the issue? The answer is we don't know yet. That price will be set roughly 10 days after the merger has been approved. That is the broad outline of moving forward with this transaction. If you then move on to the financials, we are looking at the financial statement. It's a significant improvement from last year. I explain and go through the details a little bit here. If you look at the sales revenue, we report sales revenue of roughly NOK 11.7 million, which is divided in NOK 2.5 million in services. Then we have roughly NOK 9.2 million in the release of the lab, compared to the previous year where we only had NOK 67,000 in sales revenue. It's a significant improvement. We report operating expenses of NOK 56.2 million, which is down from NOK 78.1 million last year, which gives us an EBITDA result of minus NOK 44.2 million for the first half of 2025. This is a significant improvement. As the ones of you who have followed the company for a while will see, this is also due to the strategic focus that was the decision of the strategic focus that was made in the second half of 2024, where we decided to focus entirely on Radspherin, the development in Radspherin, and also downsize the company significantly with about one third of the staff. Now you see the results of that. At the end of this period, we were 36 full-time employees, and we had NOK 77.4 million in cash available. If you look forward on the cash runway, considering the merger and the rights issue that is now ongoing, this is a funding that will provide us to be able to get to our interim readout for the ongoing phase II program. This is a very important milestone for us as it is the first randomized trial that we do and the first randomized report that we will file. If you look at the outlook, you look going forward, we know that the clinical expenses, R&D expenses, will increase slightly going forward. That is due to the nature of how it is to manage clinical trials. We have a very committed staff with a strong focus on financial discipline. We don't anticipate that there will be any changes, material changes in the cash burn as we see it now. Also, when it comes to the further financing of the company, that is something that we continue working on, both in terms of strategic options towards partners and investors. That is an ongoing work that has picked up quite a bit and receives quite a bit of attention from our side. With that, I will leave it to Øystein to talk a little bit about the upcoming milestones before we move on to Q&A. Very briefly, just repeating the upcoming milestones. Two important ones. One at the end of 2025 with the final data in ovarian cancer. The first randomized data in the form of an interim phase II data coming one year later in the second half of 2026. That concludes the presentation, and we move on to the Q&A sessions. Those of you who have not asked questions, there's a box in the lower right-hand corner where you can post your questions. We can start with the first one. There's one question coming in here. How pleased are you with recruitment? Do you have control on recruitment? Do you see kind of the end of the tunnel for this? We don't think that there is a problem with recruitment. We have chosen a very select patient population, but we know that that patient population exists. Before the summer, we had steady recruitment into the trial. We know the patients are there. We also know that the best way of securing maximum recruitment into the trial is to work with the sites, help them to identify the patients, and also to increase the number of sites that are recruiting into the trial. I mentioned we have six sites at the moment in Spain, Belgium, Norway, U.K., and the U.S. During the summer, we have been able to secure approval for new sites in Spain and Italy. We're also looking at other countries to cast a wider net in order to recruit these patients. We are confident that this is going to go well. There are not many more questions. That was short and sweet. Thank you for attending, and talk to you at the next quarterly report. Thank you.
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