Medivir AB (publ)

Welcome to Medivir Q3 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing hash 5 on their telephone keypad. Now I will hand the conference over to CEO Jens Lindberg. Please go ahead.

Thank you and welcome everyone to our sort of Q3 report 2025 at Medivir. We will focus on three things today as we go through the recent quarter and as we look ahead to the next steps. a relatively eventful time. We recently announced our intent to raise capital via a rights issue, and we're holding an extra general meeting on Monday to vote on that fully guaranteed rights issue, which is supported by our main shareholders. And this rights issue will enable us to take a major step forward with our lead asset or with our main project, Fostrox. in order to generate robust and randomized data in a rapid fashion to confirm the benefit of all four strokes in combination with Lenvima. And Pia will share much more detail on this sort of as we go through the presentation today. Pia will also talk about the latest in terms of what's happening in the primary liver cancer space. We recently visited ESMO Congress, and what we can conclude, which Pia will also talk about, is the design of the study, the positioning of Fostrox sort of continues to align well with the significant unmet medical need in second-line liver cancer. And then finally, we recently announced and very pleased to announce that we have signed the licensing agreement for Remitinostat, which now has the potential to generate significant value upside for the molecule moving forward. And Fredrik will... We'll share a bit more detail on what is happening and more importantly, sort of provide a bit of an update on remittance and what we see as the logical sort of steps forward for our licensing partner. So we will come back to that as well. So presenting today, apart from myself, as I've alluded to, our chief medical officer, Dr. Pia Baumann, will talk about the full structure of the project moving forward. Fredrik will touch on Remitinostat. And then Magnus, our CFO, will sort of conclude with the financial highlights as well towards the end of the call. So with that, I will hand over to Pia, and she will sort of walk through the planned phase two study, which we are raising capital for, and sort of how that will enable rapid generation of randomized and comparative data to confirm the benefit that we've seen in the first study with the combination of FosTrox and Lendvima. So with that, Pia.

Thank you, Jansson. You can go to the next slide. Perfect. So we left ESMO here in October. It was in Berlin, a strength in our belief that there's definitely still a high need for an effective treatment in the second line advanced liver cancer. Or actually, we will call it HCC. You will see it on this slide because it's an abbreviation of hepatocellular carcinoma, which is the most common form of primordial cancer. So, coming back to this, the complete lack of prospective second-line study data at ESMA revealed again that the focus in HSE continued to be heavily shifted towards first-line advanced or earlier stages of HSE. I mean, you have all seen it, I assume, that, for example, cell therapies with CAR-Ts, ADC, targeted therapies that has been very successful in other tumor types have unfortunately not lived up to the promise in HECs. It might be the lack of actionable targets in the majority of the patients and the comorbidity with liver dysfunction causing tolerability challenges, that is the main reason. So there's a gap. And with the aim of cover this gap, we have positioned the development of FosDrox in second line post immunotherapy combination, as Jens already said. And this is now reinforced in first line, evidenced also by the presentation at ESMO. And I will shortly come back to that. So our aim with FOSDROC is very much supported also by the global experts and overall the HCC community that is very eager to have in their hands an alternative when the patients progress in first line that doesn't exist today. So we can go to the next slide. So several studies are trying to add a drug to immune therapy combination in order to further improve outcome in first line advanced HEC when it has failed. And here you can see in BRAVE-152, it was presented at ESMO with the experimental drug TIGIT that failed to show any benefit at all on top of T-centric Avastin. It was quite a large study. It was a phase 3 study with 669 patients, and it was randomized one-to-one in two arms. And you can see here down to the left the superimposed Kaplan-Meier problem curve of progression-free survival. So that was disappointing, but it is also entrenching the position for dyscentric Avastin in first line and a standard of care. It is a medium progression-free survival. Here it's eight months, but it has been somewhere between six and eight months in first line. And we know that all patients eventually progress. And again, why an effective second-line treatment is very much needed. And here to the right, you can see part of a treatment guideline, and it still suggests a clinical trial as the best option in this patient population due to the fact that there are no results from second-line studies with this setting that we have today. You can go to the next slide. so the current trend in oncology overall is to use systemic therapy in earlier stages of disease and aiming for a curative treatment also when it is a little bit more advanced than sort of the early stages and this has also been tested in hcc with somewhat disappointing results A couple of years ago, they suggested to use adjuvant systemic treatment after surgery, and it failed to show any benefit. And while seeing early signs of promising effect, looking at progression-free survival that you see here to the left, with immunotherapy in an earlier stage of hse intermediate state where it's localized in the liver when they looked at a longer follow-up overall survivor showed no significant improvement with katruda and lenvima in addition to local treatment with taste and this is the leap 012 study And the study was closed. So this again reinforces immune therapy combinations to be used in later lines, advanced HSE, and in the first line setting, which makes the strategic development of FosDrox plus Lumima in the second line post-immunotherapy setting an obvious choice. You can go to the next slide. So to support the evidence that we already have from the phase 1 A to B study with FosTrox plus Lanvima in second line advanced HEC, the next step will be a randomized comparative phase 2 study where we will enroll 80 patients with one prior immunotherapy combination. And they will receive either FosTrox 30 milligram together with Lanvima And the dose for Lenvima will be the standard weight-based doses. And it will be randomized against Lenvima as monotherapy. This will be done at eight sites as part of the Korean Cancer Study Group that we are collaborating with. Enrollment is estimated to 12 months and primary endpoint follow-up will be between three and six months, depending on when the response is seen. So, as previously done, imaging assessment will be done every six weeks with CT scan or MRI. And the FICAS endpoint, including the primary endpoint, which is going to be overall response rate, will importantly be evaluated by a blinded independent central review. So the collaboration with an established research consortium as the Korean Cancer Study Group will also ensure that we will generate robust comparative efficacy and safety data. And as Jens already said, with a rapid data readout, which is important for us in the development of OSTROX. And with the confirmation of improved efficacy that we are hoping for with FosTrox plus Lenvima compared to Lenvima alone, in this randomized setting that we will have in this study, we will use this data to make a more accurate assumption that will actually strengthen the design on the following registration of the study. We can go to the next slide. But we are not there yet, right? Before we have head-to-head data, we have been and we will be reliant on comparing the data we have for FosTrux plus Lenvima with the limited publication of Lenvina monotherapy in second life. So the Korean Cancer Study Group has recently finalized such a prospective study with lenvatinib or with lenvima post-immune therapy. Why this specific research consortium is the optimal one to collaborate with in the upcoming randomized phase two study. And the LENVIMA monotherapy study enrolled 50 patients at 13 sites, and the efficacy was shown to be superior to other TKI, not in this study, but if you compare. And it was very much similar to what previously had been shown with retrospective analysis of LENVIMA in second line. And here you can see a median progression-free survival of around 5.4 months, median overall survival 9.8 months, and an overall response rate of 14%. And without other effective options, as we already talked about, there is nothing that is sort of suggested or aligned upon in second line. This support Lendvima use post-teccentric Avastin. And we know already from before that the clinicians prefer to use Lendvima in this setting. We can miss that. So the patients in the Korean LENVIMA monotherapy study had similar patient characteristics as the phase 1 B2A study with FosTrox plus LENVIMA. And this was, I don't know if you can see this, but it was very much the age, gender, liver function, if it was viral, non-viral, AFP levels, and prior systemic and local treatments. And when doing indirect cross-study comparison, we actually did that. We can go to the next slide. we can see that FOS drugs plus Lanvima provided substantially better outcome data compared to Lanvima monotherapy. This should, of course, be interpreted with caution, and that's why we are doing the randomized study. But here we could see that the median progression-free survival of 5.4 months When you compare that monotherapy data with lenvima to what we saw with FosTrox plus lenvima, time to progression was 10.9 months. The response rate was 14% with the lenvima mono. We had 24% with FosTrox plus lenvima in this study. And the median overall survival of 9.8 months in the phase 1b2a study was 13.7 months with FosTrox plus lenvima. So this is encouraging, really encouraging for the future development of OSTROX. And I will leave it back to Jens to continue talking about this.