Oncoinvent ASA

I'm Øystein Saug, I'm the CEO of the company and with me today I have Kari Myhren, the Chief Medical Officer. And since this is not a half-yearly report and merely a quarterly update, we will just give you an update of 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. So the biggest highlight of the quarter was certainly the final data in ovarian cancer, our phase one trial that read out in October. Kari will give you a detailed overview of those data in a few minutes. But also on the colorectal cancer side, we actually announced the data before the summer. But now, just last week, we presented the data on 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 Bergen Bio, thereby also uplisting from Your Next Growth to Oslo Börs main market. And we also have announced and secured a fully underwritten rights issue to be executed in November. And first let's talk about the merger with Bergen Bio. So 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 Onkin. Now, for US shareholders, this does not require any particular action, but the Bergen Bio shareholders, they will now see their shares listed under a new name and under a new ticker. Now, following the merger, we will also, as announced in June, execute a fully underwritten rights issue of 130 million kroner. Now, 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. And then on the 13th of November, all existing shareholders will receive subscription rights, which will be tradable from the 17th to the 25th of November. And the subscription period for the shares themselves will be open until the 1st of December with payment on the 4th. So 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 45 million kroner in the bank at the end of the quarter. Through the merger of Bergen Bio, we will have an additional 45 million cash coming from the Bergen Bio side. And as I mentioned, there will be a fully underwritten rights issue in November of 130 million kroner, 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 175 million kroner 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 see on this slide in the second half of 2026 represents our first randomized interim data in the phase two trial in ovarian cancer. Clearly our most important data point so far and with the new cache OncoInvent will have runway beyond this data point and into 2027. So with the cash at hand, we can get to our first phase two data. And with that, I give the word to Kari to take us through the clinical update, Kari.

Thank you, Esten. Good morning. So 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 one to eight trials with the data from the colorectal cancer study presented this summer. And now we have also read out the top line data from the ovarian cancer trial. So I will present today the highlights of the findings from this very recently completed phase 1 trial in ovarian cancer. So you can see here the study design for the two phase 1 to 8 trials were quite similar. The phase 1 trial in ovarian cancer was performed in patients after they had a recurrence of their disease, meaning in patients that were suitable for undergoing surgery when they had disease relapse. So the study was single arm, open label, and all patients received RAD-Sverin two days after surgery. We tested different dose levels in predefined levels from one up to seven megabecquerels. So that for each dose levels, we tested that there was no safety concerns and then increased to a higher level if then that could be opened if there were no concerns. So, since there were no safety issues, no dose-limiting toxicity, we ended up going up to the highest level of 7 megabecrel, and then patients were followed up in two years after that. So, in addition to completing the dose escalation, when we had selected recommended dose, additional patients received this dose in an expansion cohort. So in total, the study recruited 21 patients across those levels and then 10 patients received the recommended dose of seven. We had four sites recruiting in the trial. So here in Oslo at the Norwegian Radium Hospital and additionally in Belgium and two sites in Spain. So, as I mentioned, the main objective of this study was to assess the safety and toxicity of radsferin in this first in human study. And 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. So the number of events do not reflect the number of events related to RADS3, which were very, very low. The most frequently reported adverse events were nausea, abdominal pain, constipation, urinary tract infections. And 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. So if you take the number of events and look at the patient number in the different cohort, you can see it could be given the impression that the higher number of events in the seven dose, but that's because we have more patients treated with this dose. There were six serious adverse events reported, which only one was reported as related to Radsferin. This was actually a procedural complication where there was a disconnect between the syringe and the catheter. So we're not a drug response as such, but later we have changed this connector to have a secure locker and there's been no similar incidents lately. Yeah. And 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 were zero. So 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 megabecquerel dose, only one patient experienced a peritoneal recurrence. And for this particular patient, it should also be mentioned that it was also actually a case where there were some uncertainty if there was something already on the imaging directly after surgery. So this was biopsied nine 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 and the very important point here is that these lymph node recurrences have some 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. And 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're seeing in the colorectal cancer study. So all in all, very encouraging for our continued development program. And then we have the phase two randomized trial that Esten also mentioned. We will have first interim results from this study towards the end of 2027. In this phase two 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. And in this trial, we have specifically chosen patients that will receive pre-operatively chemotherapy, so neoadjuvant chemotherapy, and also the 50% of the ovarian cancer population that has a very limited, if any, effect of PARP inhibitors. So after we completed the safety run-in in March, we are now randomizing patients two to one to either receive Radsferin or a standard of care. Patients will be followed every three months up to two years and we will have a primary endpoint with progression-free survival. Six study sites are actively recruiting both in the US and in Europe. And you can see also we have the four of the same sites from the phase one trials here in Oslo and in Belgium and in Spain and additional sites in the UK and the US. So 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 August were seasonally limited, but 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. And 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. So to achieve this number of 96 patients per protocol, we have accounted for including a total of 108 patients. Of course, the speed of recruitment is of critical importance for us. To make sure that we maximize this potential, 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. So lastly, I just wanted to give an update for the colorectal cancer phase 1 trial, so 1-2a trial. Øystein already mentioned it, but the study was presented last week at the SOGI conference in Barcelona. So 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. So this is a very specialized Congress focusing solely on peritoneal malignancies. And 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. So I think very much a good confirmation of the route that we are on for Radsferiden. With that, I give the word back to you, Esen.

Good. So thank you, Heidi. Summing up, we have now completed our phase one program with good results, and we are starting to wait for the data next year in the randomized phase two trial. So exciting times ahead. In terms of the next meeting, 26th of February, we will have a half-year report for 2025, and we welcome you all back then. But before then, let's see if there are any questions.

There are a few questions to both of you. We can start with Kari. What does the procedural complication mean under study in drug adverse events?

Yes, so this was actually a patient where during the administration, during the surgery or after the surgery, a catheter is left behind. And that catheter is used for the drug administration. And then you have to put the syringe with Radsferin onto this catheter. And then actually when the drug was injected, the syringe disconnected from the catheter. And that resulted in a spillage of drug. So there needed to be a decontamination of the room, but there were no events for the patients. So patients have been followed up and there's no concerns about the patient but of course we have taken this very seriously and then we have as I said changed this connector and we have put in like a screw function with a lure lock so that we have done a lot of dry runs to make sure that this will not happen again.

Thank you. Then another one. You referred to the changes in protocol. What changes to protocol has been made?

Yes, 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 it's an impact of the HRD status of the patient for the effect of Radsferin, but they have very different prognosis. So we have a test for HRD that identifies patients for the trial. So in the beginning, this was not routine testing at all hospitals, and then we had a centralized testing with a specific kit that we shipped to the US. But 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. So 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. So to adjust it as much as possible to actually what the clinical practice is.

Thank you. And then there is another one concerning the number of sites. Regarding the increasing of the number of study sites, how is this progressing? Public research shows that there are still six active sites in the EU and the US.

Was the last part you said?

There are still six sites being registered as active in the EU and the US, 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 UK. So all the 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. So some of them are taking a bit longer for that because of the separate regulatory approval.

Thank you. Then there's one concerning the speed of recruitment. At the current recruitment speed, which obviously is an historical point, how meaningful will the interim data after nine 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 rates, but we are really confident that we will have sufficiently enough number of patients at this time point. And some of them will have quite extensive follow-up time, some will have shorter follow-up time, but we do really believe that there's a meaningful readout point with this planned interim analysis.

And then there's one for Øystein. What is the plan of 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, Carl, you 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. But right now, or let's say for the last one and a half years, there has been a very clear focus concentrating on ovarian cancer in on-comment. 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 two 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. But what we see, and I would say particularly from investigators and particularly for those investigators who have been involved in treating patients with Radsferrin, we see a very high level of interest in continuing