Oncoinvent ASA (ONCIN.OL) Earnings Call Transcript & Summary

Good morning to everyone watching live, and hello to those of you who watch the recording of Oncoinvent's Third Quarter update for 2025. Today is the 4th of November. I'm Oystein Soug. I'm the CEO of the company. And with me today, I have Kari Myren, 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 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. So 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. 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 BerGenBio, thereby also uplisting from Euronext grows to Oslo Børs main markets. 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 BerGenBio. 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 mainboard under the old ticker ONCIN. Now for you as shareholders, this does not require any particular action, but the BerGenBio 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 NOK 130 million. 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 fourth. 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 NOK 45 million in the bank at the end of the quarter through the merger of BerGenBio, we will have an additional NOK 45 million cash coming from the BerGenBio side. And 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 acquired 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. So with the cash at hand, we can get to our first Phase II data. And with that, I give the word to Kari to take us through the clinical update, Kari.

Thank you, Oystein. Good morning. So this is a snapshot on where we are at with our clinical development program. As you can see on the top 2 lines here, we have just completed both our Phase I/IIa 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 we'll present today the highlights of this -- of the findings from this very recently completed Phase I trial in ovarian cancer. So you can see here the study designed for the 2 Phase I/IIa trials were quite similar. The Phase I trial in ovarian cancer was performed in patients after they have a recurrence of their disease, meaning patients that were suitable for undergoing surgery when they have disease relapse. So the study was single arm, open label, and all patients received Radspherin 2 days after surgery. We tested different dose levels in predefined levels from 1 up to 7 MBq, so that for each dose levels, we tested that there was no safety concerns, so then increase to a higher level if then that could be open -- 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 MBq. And then patients were followed up in 2 years after that. So in addition to completing the dose escalation, when we had selected a recommended dose, additional patients received this dose in an expansion cohort. So in total, the study recruited 21 patients across dose levels and then 10 patients received a recommended dose of 7. We had 4 sites recruiting in the trial. So here in Oslo at the Norwegian Radium Hospital, and additionally in Belgium and 2 sites in Spain. So as I mentioned, the main objective of study was to assess the safety and toxicity of Radspherin 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 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. 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 cohorts, you can see there it could be, given the impression that there's a higher number of events in the 7 dose, but that's because we have more patients treated with this dose. There were 6 serious adverse events reported, of which only one was reported as related to Radspherin. This was actually a procedural complication where there was a disconnect between the syringe and the catheter. So not a drug response as such. But -- and then later, we have changed this connector to have a secure locker and there's been no similar incidents lately. Yes. And as you can see also here, if you look at the last line here, the number of study drug-related adverse events, grade 3 or higher were 0. So obviously, a very benign safety profile and very kind of in line with what we were hoping for, for the product. Obviously, this was -- 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 1 patient experienced a peritoneal recurrence and for this particular patient, it should also be mentioned that it's also actually a case where some uncertainty if there was something already on the imaging directly after surgery. So this was biopsy, 9 months later, but -- so it might not have been really a true recurrence, but we have in transparency reported this as such. In addition, there were 2 patients that experienced extra abdominal lymph node recurrences and the very important point here is that this lymph node recurrences have so 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 side. 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 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've seen in the colorectal cancer study. So all in all, very encouraging for our continued development program. And then we have the Phase III randomized trial that Oystein also mentioned, we will have a 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. And in this trial, we have specifically chosen patients that will receive pre-operative chemotherapies, 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 2:1 to either receive Radspherin 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. 6 study sites are actively recruiting, both in U.S. and in Europe. And you can see also we had the 4 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. So an update on recruitment. All these 6 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 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 a 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. So lastly, I just wanted to give an update for the colorectal cancer Phase I trial, so 128 trial, Oystein already mentioned it, but the study was presented last week at the PSOGI 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 novel treatment that can supplement the surgery and to keep patients in remission for a long 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 Radspherin. With that, I give the word back to Oystein.

Good. So 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. So exciting times ahead. And 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.

A few questions to both of you. We can start with Kari. What does the procedural complication need on the study drug adverse event.

Yes. So this was actually a patient where during the administration the Radspherin, during the surgery or after the surgery, a catheter is left behind. And that catheter is used for the study drug administration. And then you have to put the syringe with Radspherin onto this catheter. And then actually, when the drug was injected, they would get the syringe disconnected from the catheter. So -- and that resulted in a spillage of drug. And of course, but there were no -- 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 luer lock so that we have done a lot of dry runs to make sure that this will not happen again.

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. We have -- 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 Radspherin has an -- or it's an impact of the HRD status of the patient for the effect of Radspherin, 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, sometimes we have a centralized testing with specific kits that we ship to the U.S. 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's the clinical practice is.

Thank you. And then there is one concerning the number of sites. Regarding the increasing of number of study sites, how is this progressing? Public register shows that still 6 active sites in EU and U.S. with 1 underway...