Welcome to Medivir Q2 Report 2025. During the questions -and -answers session, participants are able to ask questions by dialing pound key five 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. We look forward to walking through the progress we've seen in Q2 and to address key questions as we continue our preparations for the phase II-B study with fostrox and Lenvima. If we look back at Q2, or if we look even further than that, to start, we presented final data from the now closed phase I-B/II-A study with fostrox plus Lenvima in Q1. Interestingly, 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. We also continue to follow what's happening competitively in the second-line liver cancer space, especially when there are new data presentations at major congresses. Q2 saw two of those congresses take place, ASCO in the U.S. and ESMO GI here in Europe. We can conclude, as we have concluded many times before, that the combination of fostrox plus Lenvima in second-line does maintain a front-runner position in second-line. Pia will come back to this in a bit more detail. Importantly, patent protection is critical when we develop drugs. In Q2, we saw another major patent authority, in this case, Japan, approve the very important fostrox plus Lenvima patent, providing protection until 2041. This particular combination patent is a key element in the fostrox patent strategy. With Japan following on from the EU and also Australia, it is a very good sign and signal and makes us look forward to additional 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. 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. This molecule is the molecule they used to combine with birinapant. They also combined with other molecules. As a result, when they were acquired, they have returned birinapant to us. 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. We will come back on this and touch on this at the end as we go through our financial situation. With that, as I said, in the room, apart from myself and Magnus, Pia will go through some of the data from the recent congresses. We are joined by our CSO, Fredrik, who is here for the Q&A session as well. With that, starting 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. As Jens said, ASCO and ESMO GI has taken place this spring and summer. In second-line, where we are developing fostrox and lenvatinib, the data has been scarce and in line with what has been shown previously. It confirms sort of fostrox plus lenvatinib as a promising second-line treatment in advanced HCC. There is this huge gap in clinical data in second-line advanced HCC, and that is really the reason why there is no consensus of what treatment to use. The recommendation, as 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 use more or less what is available or what has data in first-line or has been used often for lenvatinib. Also, what is again confirmed is that immunotherapy is established in first-line and will remain in this setting with Tecentriq 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. This sounds a little bit crazy, actually, at a conference that is focusing on liver cancer. At ESMO GI, there was only one presentation with prospective clinical data in the second-line HCC setting. This presentation used cabozantinib in second-line. It's not only after I, you can see to the left here, but it was mainly Tecentriq Avastin atezolizumab that was used in the first-line setting. 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%. 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. That was from a prospective registry from Europe, a Levi-Tian study that looked into 230 patients that had received either sorafenib or lenvatinib in the second-line setting, trying to understand sort of, okay, what is the outcome in the second-line setting? 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. This is more or less what was presented at ESMO GI when it comes to the setting where we are developing fostrox plus lenvatinib. There has also, if we go to the next slide, there has also been a recent review published in Annals of Hepatology in February this year, where they looked into the data for in the second-line setting. It is both prospective and retrospective studies here. All in all, you can say that all of this data confirms what we have seen previously with an overall response rate of, yeah, less than 10%, disease control rate of around 65%, and median progression-free survival or time to progression of around four months. This can be, if you go to the next slide, and this data can be compared to what we have shown in the phase I-B/II-A study with fostroxacitabine bralpamide plus lenvatinib, where we saw an overall response rate of 24%, a disease control rate of 81%, and a time to progression of 10.9 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 HC. With this limited clinical data in second-line and the development in HC is really focused in first-line liver cancer. There is, however, a continued support of immunotherapy in the first-line setting. It's solid. It's further supported by quality of life, an endpoint that has not been so much in focus in oncology development. 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 anti-cancer treatments. It could also upgrade the overall assessment of therapeutic efficacy. 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. If you go to the next slide, we can see also a recent publication in support of immunotherapy 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 Tecentriq Avastin or atezolizumab outperformed all other treatments and provided the best balance between quality of life preservation, that quality of life didn't deteriorate, together with overall survival in advanced HC. Our firm assumption is that Tecentriq Avastin will continue to be the preferred first-line treatment option also in the future. Our plan, the phase II-B study, post-immunotherapy, will reflect the future treatment algorithm. The results from our study will be relevant for the high unmet need in the second-line setting. With that, I will leave it back to Jens. Thank you, Pia. Yeah, I mean, the question is always sort of why do we hone in on sort of the first-line treatment? That is, I mean, when we plan for the next phase, it's important that we also plan for a phase that will survive over time. This is why it's encouraging and important that sort of the design of the study that we have, the phase II-B study, with an immunotherapy, with the Tecentriq Avastin sort of in first-line and then progression, that that treatment algorithm is the right one today. That treatment algorithm will stay the same over time. Encouraging from that data set to see that Tecentriq Avastin first-line will remain cemented. The other part, again, if we look at this slide, and this is just the treatment algorithm, on the bottom here, i.e., the second line where there are no approved options, this is where we are targeting. Again, we are focused on where the biggest unmet medical need is. There hasn't been anything new come into play. As Pia alluded to or showed, the data that we've seen as of late confirms that sort of the front-runner position we have with the combination remains intact. Just to kind of reiterate what we talked about before, a couple of things. One, we know that sort of the second-line HCC space is a very large and growing commercial opportunity. When we get to sort of 2030, we're looking at almost like a $3 billion market. If anything, that is likely to be bigger. Again, looking at sort of what we see in terms of evolution perspective, we've talked about this before as well. Just to kind of emphasize that liver cancer is likely to grow faster than previously anticipated, driven by the alarming increase in fatty liver disease and the risk of fatty liver disease patients being diagnosed with liver cancer. With that, considering the market, the size of the market, the market is only going to grow, and our opportunity and our belief that we can be the first approved treatment option in second-line, then it becomes critical to work and strengthen our IP patent strategy and strengthen the patent family. That's why the combination patent and approval now in Japan is such a key. It's especially sort of just kind of stop on this. It's especially important for a product like fostrox, which is focused on a particular tumor type. Here is the patent for the combination with Lenvima, which is then sort of the combination we are developing. It's for use in liver cancer. It means that that is the and will be then the approved use, meaning that it would be difficult for a generic to come in and challenge the patent and say that and argue that fostrox is being used in a different tumor type since it will only be approved in liver cancer. Hence, this type of use patent becomes extra strong for a drug with that type of tumor type focus. Very happy that Japan approved and looking forward to approval from other regions as well. With that, we move into the financial. Thank you, Jens. Next slide, please. We can see the financial summary for the second quarter and year-to-date for former Q2. The result in cash flow, it was really in line with our forecast. Turnover is slightly higher in Q2, primarily driven by royalty income from Sinclair. I'll give you some comments regarding external expenses. As you can see, they're significantly lower than last year, mainly due to the reduced clinical costs following the completion of the study in November last year. Although we have some clinicals in the quarter, we will have some additional wrap-up costs expected in Q3 as well. We have made some CMC investment in the quarter for the planned phase II-B study. We estimate a lower cash outflow in the coming months. We continue to work to reduce the cost base that we have today. Some final comments regarding the cash position. We have strong support from Bink, our largest shareholder. We have utilized the loan facility of SEK 30 million during the quarter. With that, we have a cash balance end of June amounts to SEK 38 million. The estimated cash runway is now end of Q4 under the current plan and the current assumptions that we have today. I will hand back to Jens for some final comments. Thank you, Magnus. Just to touch on this, I mean, in our current situation, our number one focus is, of course, to conclude on the best way forward financially for fostrox. As soon as we have final clarity on that, we will, of course, communicate. What I can say is that we are in active discussions with different parties to land on the best way forward. Before having concluded those discussions, we are very much grateful for the support and the belief shown by our main owner, Bink, providing the loan facility, as that enables us to follow through on those discussions. It is difficult to say more at this stage than to reiterate that this is our key priority at the moment. We will, of course, communicate as soon as we have concluded on those discussions. With that, we'll stop there and then open up the line for questions. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Joe Pankinas from H.C. Wainwright. Please go ahead. The next question comes from Richard Ramanius from Redeye. Please go ahead. Hi, this is Josh on for Joe. I have a question about birinapant. Now that you've regained all the rights to it, is there any additional color you can provide on how you think about moving it forward? Birinapant is an interesting molecule. It has a great safety profile. It does what it's supposed to do mechanistically in cancer cells. We're currently evaluating several different. Did you answer the previous question? Yes, that's correct. I think there's some time delay issue here. Not sure if we have technical challenges here. So far, we've heard one question from Josh at H.C. Wainwright regarding birinapant. We can just conclude that with the observation that we're currently working to find a path forward for birinapant. We think it's still a very interesting opportunity, both in terms of there are many different combinations out there that are potentially useful and also various indications. Is it my turn to ask a question? That is where we are currently. Again, from a technical viewpoint, not sure if we are being heard or not. Yes, you are. OK, good, good. Hopefully that answers the birinapant question. It sounded like the next person in line was Richard from Redeye. Please go ahead, Richard. We seem to have a problem with Richard's line. We did hear Richard a couple of times before. Yes, can you hear me? We can hear you now, Richard, yes. Yeah, can you hear me? Yes. We can hear you. I'll just ask a question. Are your other external expenses increased a bit from Q1? OK, I could hear your question, Richard. Yes, the main reason behind that was the investment we did in CMC. That's the investment for the planned phase II-B. That's the main reason for that. Jens says something about the funding and deal environment in oncology. It's been a bit tough until now. Do you see it changing going forward? I think the obvious answer would be yes, I think that it will change. It's been a difficult sort of situation in a couple of years. Interestingly, when we look externally, we've seen some encouraging news, arguably as of late. I think inevitably it will swing back. From our position, we are in and have been in discussions with regards to finding the best way forward. We look to conclude those discussions. That's the key focus from our end. That's not dependent on a shift in the environment, et cetera. We just want to make sure we conclude on those discussions. Clearly, considering our financial situation, those discussions we want to bring to a close as soon as we possibly can, of course. Sure, thanks for answering my questions. I think the only. The next question comes from Klas Palin from DNB Carnegie. Please go ahead. Yes, hello there. Thanks for taking my question, if you can hear me. We can hear you. Perfect. My question relates to the financing then. Hello. We can hear you. Go ahead. Magnus indicated that your cost would perhaps come down somewhat in the coming quarters. I just wonder if that's related to your pausing some initiatives in your preparations for the phase II-B study, or is it just how it should be? No, it's mainly related to that we have some, even though we completed the study in November last year, we still have some clinicals according to our agreement with our CRO. We have some clinicals during the first half of this year, and we will have some wrap-up costs during Q3 this year. The preparation are going according to the plan for the planned phase II-B. If you would be able to secure funding in the coming months, would it be possible to initiate the phase II-B study before year end? Or when do you think it would be possible? I can respond to that. All the preparations, as Magnus has already said, is ongoing. When we sort of have all the financials in place, we are ready to just press the button and start the study. It's always difficult to give it. Thank you very much. People are eager. We're being pushed at every Congress. Let's start as soon as you can. I think that's the short answer. As I think that I provided a little bit earlier, this is such a high unmet need. There are no current studies ongoing more or less. It's really anticipated that we start the study as quick as possible as soon as we have the financial part ready. I'm just looking to understand if you start losing some time now as we await sort of a more proper financing. The time is, yeah. Clearly, the sooner we secure the financing, the better from a timing perspective. This is one of the reasons why we wanted to spend a bit of time on, are we losing the momentum? Are we losing our place in the queue? Are we seeing anyone moving ahead of us? We're not seeing that. Clearly, that doesn't mean we want to delay things. That part is good to see. Of course, let's secure the financing and be able to start as soon as we possibly can. Perfect. Sounds very good. Good luck with that, and thank you for taking my question. Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more questions at this time. I hand the conference back to the speakers for any closing comments. Thank you. Just to sort of go back to our overview slide, which we've talked about a few elements today, we continue to be at the forefront. We are the first and only liver targeted agent. We've shown quite, with the data we showed in Q1, encouraging data set with 10.9 months time to progression. Pia showed today, again, additional studies confirming that is significantly different, or it's clearly longer than what we've seen in other studies in second-line. There's nothing improved. The window towards becoming the first approved treatment option in second-line is there. The market is significant. The market is likely undervalued or underestimated in light of the sort of fatty liver disease explosion that we're seeing. Clearly, again, just to come back to it, just to make that point, our number one focus, apart from making sure that we progress all the preparations for the study, as evidenced by CMC investments we're doing to make sure that we are prepared, our number one focus is to conclude on the financial solution to find the best way forward and to conclude the active discussions that are ongoing. As soon as we have clarity and as soon as we have landed on that best way forward, we will communicate as soon as we can. Thank you, everyone, for dialing in. Have a good rest of the day.