Medivir AB (publ)

Welcome to Medivir Q2 Report 2025. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Jens Lindberg and CFO Magnus Christensen. Please go ahead.

Thank you. Welcome everyone to our Q2 report here at Medivir. And we look forward to walking through progress we've seen in Q2 and to address key questions as we continue our preparations for the Phase 2b study with Fostrox and Lenvima. If we look back at Q2, or if we look even further than that, so to start, we presented final data from the now closed Phase 1b two-way study with Fosstruxibus lenvima in Q1. And interestingly, sort of basically as of today or one of these days, the patient who has been longest on treatment has now been treated with continued benefit for three years, which is a very, very long time for a second line liver cancer patient. What we also do, we continue to follow what's happening competitively in the second line liver cancer space, especially when there are new data presentations at major congresses. And Q2 saw two of those congresses take place in ASCO in the US and ESMO-GI here in Europe. And we can conclude, as we have concluded many times before, that the combination of Ostrox plus Lenvima in second line does maintain a front runner position in second line. And we will touch on this, and Pia will come back to this in a bit more detail. Importantly, patent protection is critical when we develop drugs, and in Q2 we saw another major patent authority, in this case Japan, approved the very important FosTrux plus Lenvima patent, providing protection until 2041. This particular combination patent is a key element in the FosTrux patent strategy, and with Japan following on from EU and also Australia is a very good sign and signal and makes us look forward to additional sort of patent approvals in other key regions. Thirdly, in Q2 we have or had a partner in IGM Biosciences. They were acquired by Concentra in Q2 And one of the reasons why they were acquired is that they had some setbacks in their own portfolio, one of them being the lack of activity seen with their own DR5 agonist. And this molecule is the molecule they used to combine with brinapant, and they also combined with other molecules. So as sort of as a result, that means that we have they have then sort of when they were acquired, they have returned brinopant to us. And moving forward, we will, of course, evaluate the best option forward for the molecule. Finally, in our current financial situation, key focus at the moment is to land the best possible solution to finance the next step. And we will come back on this and touch on this at the end as we go through our financial situation. But with that, and I said sort of in the room, apart from myself and Magnus, then Pia will go through some of the data from the recent congresses, and we are joined by our CSO, Fredrik, who is here for the Q&A session as well. So with that, and start from the top, I will hand over to Pia to take us through the recent events in the liver cancer field and what it means for the FosTrox plus Lenvima combination.

Thank you, Jens. And as Jens said, ASCO and S4GI has taken place this spring and summer and in second line where we are developing FosTrox and Lenvatinib. The data has been scarce and in line with what has been shown previously, and it confirms the promising second-line treatment in advanced HSC. There is this huge gap in clinical data in second line advanced HEC. And that is really the reason why there is no consensus of what treatment to use. And the recommendation that you can see from this ESMO-GI presentation is still to include these patients in a clinical study. Not all patients will have a clinical study available and then you use more or less what is available or what has data in first line or has been used after sorafenib. And also what is again confirmed is that immune therapy is established in first line and will remain in this setting with the T-centric Avastin, or as it will say in all these slides, atezolizumab plus Bevacizumab, particularly in first line, which is used in around 90% of the patients in first line. You can go to the next slide. So this sounds a little bit crazy actually at a conference that is focusing on liver cancer, but at ESMO GI there was only one presentation with prospective clinical data in the second line HEC setting. And this presentation used cabozantinib in second line. And it's not only after eye. You can see it to the left here. But it was mainly that was used in the first setting. And in this study, there was a median progression-free survival of three months and an overall response rate of, it was only one patient that responded, of 4.5%. And this is really in line with what we have seen previously. I can show you some more data if we go to the next slide. And that was from a prospective registry from Europe, a Levy-Tian study that looked into 230 patients that had received either serafinib or lenvatinib in the second-line setting, trying to understand sort of, okay, what is the outcome in the second-line setting? And this study really also confirmed what we have seen before with the median progression-free survival for lenvatinib of 5.5 months and a disease control rate of 60% with lenvatinib. We didn't have any data of overall response rate from this study since it was a prospective registry. So this is more or less what was presented at Esmondea when it comes to the setting where we are developing post-trugs plus Lambertinib. There has also been a recent review published in Annals of Hepatology in February this year where they looked into the data in the second line setting. And it is both prospective and retrospective studies here. But all in all, you can say that all of this data confirms what we have seen previously with an overall response rate of less than 10%, disease control rate of around 65%. and medium progression-free survival or time to progression of around four months. And this can be, if you go to the next slide, and this data can be compared to what we have shown in the phase 1b2a study with post-drugs, plus Lemvatinib, where we saw an overall response rate of 24%, a disease control rate of 81%, and a time to progression of 10.2%. nine months, which is substantially better than what has been seen with lenvatinib, with other TKIs, or with immunotherapy combination in the same setting in second line advanced HSE. And with this limited clinical data in second line, and the development in HSE is really focused in first line liver cancer. There is, however, a continued support of immune therapy in the first-line setting. It's solid. And it's further supported by quality of life, an endpoint that has not been so much in focus in oncology development. But recently, ESMO and also at ESMO-GI, where there was a session that only was talking about quality of life, ESMO recognized now health-related quality of life as a key parameter in determining the clinical value of anticancer treatments. And it could also upgrade the overall assessment of therapeutic efficacy. And why am I saying this here now? It's because to understand sort of what treatment algorithm is currently the one that we are working in. And if you go to the next slide. We can see also a recent publication in support of immune therapy in first line where they integrated health-related quality of life in addition to overall survival, the most important endpoint in liver cancer, and showed that Ticentric Avastin or ATSO-Bev outperformed all other treatment and provided the best balance between quality of life preservation that quality of life didn't deteriorate. together with overall survival in advanced HEC. So our firm assumption is that T-centric Avastin will continue to be the preferred first-line treatment option also in the future. And our planned Phase IIb study for post-immunotherapy will reflect the future treatment algorithm and the results from our study will be relevant for the high unmet need in the second-line setting. And with that, I will leave it back to Jens.