I'm Øystein Soug, I'm the CEO of the company, and with me today I have Kari Myren, the Chief Medical Officer. Since this is not a half-yearly report and merely a quarterly update, we will just give you an update on the developments of the company without the full financials. You can ask questions through the system, and towards the end of the session we will strive to answer your questions. These are the disclaimers. Today we'll go through the highlights, also the upcoming milestones, and last but not least, give a clinical update with the latest data from our trials. The biggest highlight of the quarter was certainly the final data in ovarian cancer, our phase I trial that read out in October. Kari will give you a detailed overview of those data in a few minutes.
Also on the colorectal cancer side, we actually announced the data before the summer, but now, just last week, we presented the data at PSOGI, the International Congress for Peritoneal Surface Malignancies in Barcelona. On the corporate side, during the quarter we completed our merger, or reverse merger if you like, with BerGenBio, thereby also uplifting from Euronext Growth to Oslo Børs main market. We also have announced and secured a fully underwritten rights issue to be executed in November. First, let's talk about the merger with BerGenBio. the deal was signed in June, and it was completed last week on the 29th of October. The merged company has taken the name Oncoinvent ASA, so the same as the old Oncoinvent, and is now trading on the Oslo main board under the old ticker ONCIN.
For US shareholders, this does not require any particular action, but BerGenBio shareholders, they will now see their shares listed under a new name and under a new ticker. Following the merger, we will also, as announced in June, execute a fully underwritten rights issue of NOK 130 million. The pricing of that rights issue is not yet set, so it will depend on several factors, amongst others the weighted average share price until the 11th of November. On the 13th of November, all existing shareholders will receive subscription rights, which will be tradable from the 17th to the 25th of November. The subscription period for the shares themselves will be open until the 1st of December, with payment on the 4th. Just to remind you, the raise is 100% underwritten, it's 100% guaranteed, so this will take place.
In terms of cash, the company had NOK 45 million in the bank at the end of the quarter. Through the merger BerGenBio, we will have an additional NOK 45 million cash coming from BerGenBio side. As I mentioned, there will be a fully underwritten rights issue in November of NOK 130 million, which all in all will give us a runway into 2027. Now, Kari will get the floor and talk about the clinical development in a second, but I want to show you this overview. Because the NOK 175 million that we acquire through the merger and the rights issue will indeed be very meaningful for the company. The pale green star that you see on this slide in the second half of 2026 represents our first randomized interim data in the phase II trial in ovarian cancer.
Clearly our most important data point so far, and with the new cash, Oncoinvent will have runway beyond this data point and into 2027. With the cash at hand, we can get to our first phase II data. With that, I give the word to Kari to take us through the clinical update, Kari.
Thank you, Øystein. Good morning. This is a snapshot on where we are at with our clinical development program. As you can see on the top two lines here, we have just completed both our phase I trials with the data from the colorectal cancer study presented this summer. Now we have also read out the top line data from the ovarian cancer trial. We'll present today the highlights of the findings from this very recently completed phase I trial in ovarian cancer. You can see here the study design for the two phase I trials were quite similar. The phase I trial in ovarian cancer was performed in patients after they had recurrence of their disease, meaning in patients that were suitable for undergoing surgery when they had disease relapse. The study was single arm, open label, and all patients received Radspherin two days after surgery.
We tested different dose levels in predefined levels from 1 MBq up to 7 MBq. For each dose level, we tested that there was no safety concerns and then increased to a higher level if that could be opened if there were no concerns. Since there were no safety issues, no dose-limiting toxicity, we ended up going up to the highest level of 7 MBq. Patients were followed up in 2 years after that. In addition to completing the dose escalation, when we had selected the recommended dose, additional patients received this dose in an expansion cohort. In total, the study recruited 21 patients across those levels, and 10 patients received the recommended dose of 7MBq. We had four sites recruiting in the trial, here in Oslo at the Norwegian Radium Hospital, and additionally in Belgium, and two sites in Spain.
As I mentioned, the main objective of this study was to assess the safety and toxicity of Radspherin in this first, in human study. Here you can see the overview of adverse events in the different dose levels. Of course, if you look at the numbers, the number of events is quite high, and this is really what is expected after patients undergoing major surgery. The number of events do not reflect a number of events related to Radspherin, which were very, very low. The most frequently reported adverse events were nausea, abdominal pain, constipation, urinary tract infections. Again, this is really what you expect after major surgery and early recovery. Also importantly, there were no increased rates of events in the increasing dose levels.
If you take the number of events and look at the patient number in the different cohorts, you can see there could be given the impression that there's a higher number of events in the 7 MBq dose, but that's because we have more patients treated with this dose. There were six serious adverse events reported. Of which only one was reported as related to doxycycline. This was actually a procedural complication where there was a disconnect between the syringe and the catheter. Not a drug response as such, but then later we have changed this connector to have a secure locker, and there have been no similar incidents lately. Yeah. As you can see also here, if you look at the last line here, the number of study drug-related adverse events, grade three or higher, was zero.
Obviously a very benign safety profile and very kind of in line with what we were hoping for for the product. Obviously, the main focus was on safety for the study, but we are also intrigued to look at very encouraging efficacy data. Of these 10 patients that received the 7 MBq dose, only one patient experienced a peritoneal recurrence. For this particular patient, it should also be mentioned that it was also actually a case where there were some uncertainties if there was something already on the imaging directly after surgery. This was biopsied 9 months later, so it might not have been really a true recurrence, but we have in transparency reported this as such. In addition, there were two patients that experienced extra abdominal lymph node recurrences.
The very important point here is that these lymph node recurrences have a much better prognosis compared to peritoneal recurrences and often can be resected, and the patient can live well with that. As the study was single arm, we do not have a control group for evaluation of the effect size. However, if you look at historical reported recurrence rates in this specific patient population after cytoreductive surgery in recurrence, you would expect that as much as 60% of the patients to have had disease recurrence. We should, of course, be careful to play too much with the numbers on this small sample size, but again, very much what we are hoping for and very similar to what we are seeing in the colorectal cancer study. All in all, very encouraging for our continued development program. We have the phase II randomized trial that Øystein also mentioned.
We will have our first interim results from this study towards the end of 2027. In this phase II study, based on the initial safety results and the very high unmet need in this population, we were allowed to move up from patients treated after recurrence to actually treating patients that undergo their first surgical resection. In this trial, we have specifically chosen patients that will receive preoperatively chemotherapy, so neoadjuvant chemotherapy, and also the 50% of the ovarian cancer population that has a very limited, if any, effect of PARP inhibitors. After we completed the safety run-in in March, we are now randomizing patients two to one to either receive doxycycline or standard of care. Patients will be followed every 3 months up to 2 years, and we will have a primary endpoint with progression-free survival. Six study sites are actively recruiting, both in the U.S. and in Europe.
You can see also we had four of the same sites from the phase I trials here in Oslo and in Belgium and in Spain, and additional sites in the U.K. and the U.S. An update on recruitment: all these six sites are actively recruiting patients. They have all entered patients in the study and are continuously looking for new eligible patients. Recruitment in July and in August were seasonally limited. Now we have a total of 22 patients recruited, counting all patients in the intention to treat cohort, where 19 were included in the per protocol cohort. As you can see, by the end of June, the number of patients included were 14 on both counts, meaning at that time, all patients enrolled were also treated per protocol. To achieve this number of 96 patients per protocol, we have accounted for including a total of 108 patients.
The speed of recruitment is of critical importance for us. To make sure that we maximize this potential, we have now opened, or we are in the process of opening, new sites during November and December, which will speed up the recruitment rate. In addition, we have made some selected changes to the protocol to increase some of the flexibility to make sure that we, as far as feasible, can also broaden a bit or make the protocol a bit less restrictive. Lastly, I just wanted to give an update for the colorectal cancer phase I trial, [phase I/II-A] . Øystein already mentioned it, but the study was presented last week at the PSOGI conference in Barcelona. Dr. Stein Larsen here from the Norwegian Radium Hospital presented the data. As you know, indicating a substantial improvement of recurrence rate as compared to the expectations in standard of care.
This is a very specialized congress focusing solely on peritoneal malignancies. I think to me also what really struck me and stood out as a conclusion from the meeting was also the confirmation of the role of surgery for these patients and the criticality of doing a complete surgical resection, but also not least, the need for a novel treatment that can supplement the surgery and to keep patients in remission for a longer period of time and thereby improve their life expectancy. I think very much a good confirmation of the route that we are on for doxycycline. With that, I give the word back to you, Øystein.
Good. Thank you, Kari. Summing up, we have now completed our phase I program with good results, and we are starting to wait for the data next year in the randomized phase II trial. Exciting times ahead. In terms of the next meeting, the 26th of February, we will have a half-year report for 2025, and we welcome you all back then. Before then, let's see if there are any questions.
[audio distortion]
There are a few questions to both of you.
Okay.
We can start with Kari.
Yeah.
What does the procedural complication mean under study drug adverse events?
Yes. So this was actually a patient where during the administration, the doxycycline, during the surgery or after the surgery, a catheter is left behind, and that catheter is used for the drug administration. You have to put the syringe with the doxycycline onto this catheter. Actually, when the drug was injected, the syringe disconnected from the catheter, and that resulted in a spillage of drug. Of course, there were no—so there needed to be a decontamination of the room, but there were no events for the patient. Patients have been followed up, and there's no concerns about the patient. Of course, we have taken this very seriously, and we have, as I said, changed this connector, and we have put in like a screw function with a luer lock so that we have done a lot of dry runs to make sure that this will not happen again.
Thank you. Another one. You referred to the changes in protocol. What changes to protocol have been made?
Yeah. So we have done a couple of things. One thing is the HRD testing, and that is the test that's used to select patients for the trial. Not because we think that doxycycline has an impact on the HRD status of the patient for the effect of doxycycline, but they have very different prognoses. So we have a test for HRD that identifies patients for the trial. In the beginning, this was not routine testing at all hospitals. We had a centralized testing with a specific kit that we shipped to the U.S. During the course of the study, this has been implemented more as clinical routine, and we have opened up now for using the local tests from the sites. That was the first amendment that we did, and that makes the logistics at the sites much easier. Additionally, we have also made an application.
We have not yet received approval finally, but we have also given some flexibility to the number of cycles of chemotherapy that patients need to have before surgery to adjust it as much as possible to actually what the clinical practice is.
Thank you. There is one concern in a number of sites regarding the increasing of the number of study sites. How is this progressing? Public register shows that still six active sites in the EU and US.
What was the last part you said there?
There are still six sites being registered active in the EU and U.S., with one underway in Italy. How many are underway, and when will they be active?
Yeah. So we do have regulatory approval for six new sites. There are new sites in Spain, new sites in Italy, and in the U.K. All the kind of regulatory approvals from the regulatory authorities and from the ethical committees and all of these things are already in place for these six sites. We are setting up the site initiation visits now during the coming weeks, and we also need to have some practicalities like having a license to handle radium 224 in place at all these sites. Some of them are taking a bit longer for that because that's a separate regulatory approval.
Thank you. There is one concerning the speed of recruitment. At the current recruitment speed, which obviously is a historical point, how meaningful will the interim data be after 9 months? And given the historical data and the general expected progression in OC, what do you expect to see?
Yeah. It's of course, as the question states, dependent on the recruitment rate, but we are really confident that we will have sufficiently enough number of patients at this time point. Some of them will have quite extensive follow-up time. Some will have a shorter follow-up time, but we do really believe that there's a meaningful readout point with this planned interim analysis.
There is one for Øystein. What is the plan on leveraging the CRC data? Do you have an external interest in exploring this further, not only partnering, but interest from specialist centers and surgeons?
Yeah. As you saw, Kari, I presented the data, and these are data that we are very proud of and that we have a wish and intention to go forward with. Right now, or let's say for the last 1.5 year, there has been a very clear focus. Concentrating on ovarian cancer in Oncoinvent. We also think it's a good idea to continue to focus all our strengths on this one indication and get to data on the phase II trial in ovarian cancer as quickly as possible and do everything to achieve that. For us right now, in order to do anything on colorectal cancer, I think we will depend on an external partner in order to lift that project.
What we see, and I would say particularly from investigators, and particularly for those investigators who have been involved in treating patients with Radspherin, we see a very high level of interest in continuing working with Radspherin.
Agree.
That was the last question.
Good. Thank you very much. Goodbye.