Medivir AB (publ)

Thank you operator. Welcome everyone to the Medivir Q1 2026 results webcast. We look back at a transformative quarter where we've strengthened our financial position. We've opened up a new rare disease opportunity with MIB 711 and we just came back from a successful and quite invigorating trip to Korea, where we visited a number of the highly engaged hospitals and investigators now sort of eager to get going in the FLEX-HCC study. Pia will share more on that particular topic in just a little bit. We've also seen our partner VetBiolix in France make great progress in the past quarter. So we are looking ahead to the remainder of 2026 with great anticipations. As mentioned, we've just come back from Korea, and the interest in the FLEX-HCC study is very strong among the hospitals. The interest to participate in the study is quite high. The Korean Cancer Study Group has added four additional hospitals in the quarter. And the interest as we were sort of visiting them was quite palpable when we had the opportunity to meet with eight of the hospitals face to face. We also do understand that perhaps the greatest interest, however, in the study is when is it starting? And we're happy to be able to convey today that we've just sort of gotten news that the first two sites are now open to start enrolling patients. Our trip to Korea came at a perfect time. We were able to engage with them just about as the study is about to open and they're about to start enrolling patients. We have also spent quite a bit of time in the last quarter of engaging externally with clinical and regulatory experts, as well as patient organization in the field of osteogenesis imperfecta to kind of confirm and finalize study design plans for the proof of concept study in the disease. We have been positively surprised. by the great interest and willingness to engage across sort of all the stakeholders and perhaps most importantly while we have made some so those interactions have led to some adjustments in our plans the overall plan uh is sort of laying firm and we've been sort of been strengthened in our belief in the potential of 7-eleven or mif 7-eleven in osteogenesis imperfecta. And then finally, as I mentioned, our partner VetBiolix continues to rapidly progress their clinical efforts with MEV701 or as they call it, VBX1000 for periodontal disease in dogs. And as of sort of end of April, they have now recruited more than 40% of the subjects in their ongoing study to confirm that MEV701 has the opportunity to be the first disease modifying treatment for the disease, which is a critical step to unlock the blockbuster potential of the drug. We and they expect results in Q4 this year, and that will be a significant potential inflection point for the program, and then also for us, of course. We will focus on those. These are our programs, as you can see, the in-house programs at the top, FosTrox for liver cancer and MIB711 for osteogenesis imperfecta. We will touch more on those two programs today and the progress we've made. And we'll also touch on the outlicensed program to BioLix, hence those that are marked in green. One minor comment to make regarding one of the other programs, and that is Remittinnostadt, is that following on from us making the agreement with BioSil Last year, the Gorlin Syndrome Alliance, which is a non-profit organization in the US supporting patients, families and healthcare providers, they have sort of actively reached out to us and then to BioCell, eager to, sort of as they heard of the news, eager to support the development in patients specifically with Gorlin Syndrome. And Gorlin syndrome patients, a genetically driven disease, and that manifests predominantly as patients get multiple BCC lesions, where surgery is many times not a good option. So for them, development of rematinostat in that particular rare disease subpopulation is critical and that's also our understanding from discussions with BioCell as they license the drug that might well be sort of their first development path. So interesting to see interest in that drug as well and we look forward to hearing more about their plans as we move forward. Today, I am joined by our CMO Pia Baumann, our new CFO Patrik Norgren, who joined us sort of just a month back-ish, and then our CSO Fredrik Öberg. But with that said, let me hand over to Pia to share an update on our efforts with both Fostrox as well as MIB 711, including then our recent engagements on the ground in Korea. So Pia, over to you.

Thank you, Jens. And thanks for the introduction also about sort of what has been going on when it comes to Fostrox. But just as a reminder, the FLEX-HEC study that is the reason why we went to Korea, is a randomized second line study in liver cancer. And it's really there to strengthen the evidence that we have from our single arm trial with Fostrox plus Lemvima. in liver cancer and to show superiority over Lenvima alone. So just as a reminder of what this study is, it is like Fos-Trox is combined with Lenvima in one arm and it's randomized against Lenvima monotherapy in the other arm. And it will be 80 patients that will be enrolled in this study and they should have progressed or be intolerant to prior immunotherapy combinations. And as Jan said, the patients will now be enrolled at 12 sites instead of the original eight sites due to the fact that it was a high interest. And the PI for the study is Professor Sean from Cha Bon Dan Hospital. And he is doing this study in close collaboration with the Korean Cancer Study Group. And I think that is also the reason why it is a high interest. because this group recently executed and also published actually the only prospective study with Lamartine immunotherapy in a similar patient population that will be enrolled in the FLEX-HTC study. So it's a really, really nice setup. And here the patient enrollment is expected to take around 12 months, and the primary endpoint will be evaluated by a blinded independent central review to make sure we have the quality that is required to really show this difference and since we hope this study will enroll and perform relatively quickly the top line results is expected already in 2027. So we had the opportunity to visit eight of the 12 sites last week in Korea. And right now, two of the sites are open for enrollment. And that is Chabong Dang, where Professor Chun is situated, and Severance Hospital. And we know that they are super eager to have the first patient in. As you can see on this map here, if you can see it, the site is geographically spread across Korea also to have the best chance of capturing all the patients that could be eligible for this study. And since we had the opportunity now to discuss with the investigators, it became really, really clear that there is a very high interest in participating in this study and that they have quite a few second-line patients every week that potentially could be candidates to be enrolled. Overall, the support for the study and the PI, Professor Chong, was overwhelming, and it confirms really the expertise and the quality of his name. is associated with when it comes to liver cancer studies. So overall, we were very welcome and they were extremely interested in FosTrox, also as an alternative with another mechanism of action compared to both immune therapy and TKI that is usually the one that you can use in this patient population. So we can go to the next slide. So, to summarize the takeaway from this visit, we can conclude that unfortunately liver cancer continues to be a very common disease in Korea. Despite that they now have started vaccination, it's still very common. And that while there are treatment options in first line now with immune combinations primarily, there is a high ailment need in subsequent treatment line, particularly in the second line setting where the patients Many of them can tolerate second line treatment, but still there is sort of no optimal treatment. So the sites are fully committed to the FLEX-HEC study, and it fits very well in with their standard treatment for advanced HEC. The majority will have received, 80%, something like that, will have received Ticentric Avastin, the immune combination in first line. And almost all of them is trying to have Lenvima in the second line setting. That's why this trial really fits well in. And most of the side had no competing studies ongoing in HEC. And those who actually had studies ongoing, it was mainly cell therapy or by specific targeting GPC3, which I think that all of you are interested in HEC have heard about. It has been a target that has been discussed for quite a few years now, and we are waiting for the results. But it's mainly in the first line population and selected patients there. So the interest in FosDrox is also part built on the fact that it is an all commerce population. You don't need to do any biomarking testing and it could be something that is available for more patients than those who are selected in the other GPC trials. So high interest. We can go to the next slide and I think I'll leave it to you, Jens.

Yeah, just to sort of summarize. I mean, I think first and foremost that we are, We were sort of highly encouraged that it's always good to meet face to face and sort of see that engagement commitment now with Bundang and Severance hospitals just now in open for enrollment with the other hospitals to follow sort of shortly. It feels quite good and we're very much looking forward to the progress. and and with their engagement sort of also looking forward to sort of speed of of recruitment uh for everyone just sort of summarize again uh we are sort of we do have the first and only liver activated small molecule targeting selectively targeting tumor cells uh in uh the liver uh sort of sparing healthy liver cells and that that that's also sort of clearly from from some of the hospitals we met new physicians sort of as we go through the drug in a bit more detail than i've seen before it is one of those areas sort of one of the the features that they appreciate the most So we continue to move forward. And as Pia said, there has been very little development in second line, very little competing studies. So again, our aim eventually to the right is to hopefully become the first sort of approved second line treatment in advanced CC, a market that is conservatively evaluated at sort of two and a half billion US dollars per year. But with that, and on the note of hospitals sort of opening up, we move to the second program. And let's talk a little bit about sort of what has happened with MIV 711 since we last spoke. Pia?