Medivir AB (publ)

Thank you very much and welcome everyone to our quarter one results webcast. Slightly different timing today, 10 o'clock in the morning rather than afternoon, but we will still be speaking English as we will be recording it for our English speaking friends who might be accessing the webcast later today. So we're doing early today due to the Stockholm Exchange having a half day. Moving forward, important information, which you will find when we put the presentation on our website afterwards. As we move into the Q1 results presentation, continued great progress across the business. Three key areas. Most encouragingly, as we have reported previously, the combination of FosTrox Lenvima in the ongoing study, the efficacy continues to strengthen. Pia will go through more details in terms of what we're seeing in the patient's ability to stay on and benefit from treatment longer than expected. Two, we continue the acceleration of the FosTrox development. according to plan as we come out of a supportive type C meeting with the FDA. And again, Pia will provide a bit more context on this in the call. And thirdly, also progress in other parts of the business. We announced just a week ago that we've been granted the rare pediatric disease designation for MIB 711, which Fredrik will touch upon. as we move forward to give you a bit more detail what the disease is, and we'll talk a little bit about the plans moving forward. And then finally, some progress for another one of our outlicensed compounds, MIB701. On the call today, I will be joined by our chief medical officer, Pia Baumann, and chief financial officer, Magnus Kristensen, and our CSO, Fredrik Berg. as well, and we will all be part of the Q&A session at the end. So with that, we move into the progress, encouraging progress and promising results for FosTrox. And I hand it over to Pia.

Thank you very much, Jens. And yeah, we can stay on this slide a little bit. The accelerated development, and Jens has already touched upon this, is what we have seen in the ongoing phase 1b to a startup. study is really support with the improved latest data and an increase in time to progression, the TTP to now seven months. We can go to the next slide. So just as a reminder, what are we developing here? Foster is the type of smart chemo that is really targeting the tumor in the liver. It is a capsule that you are taking orally. And with the design of this capsule, it stays stable in the GI tract until it reaches the liver, where it's rapidly activated by the enzyme there. And with this approach, it's possible to target the tumor in the liver and limiting the effect elsewhere in the body. So what happens next is that Quastrox is incorporated in the DNA in dividing cells, and this is really important. When the dividing cells then divide, post-stroke contributes to the killing of the cells. And since normal liver cells divide very seldom, post-stroke is selectively killing the faster dividing tumor cells. We can go to the next slide. So we are developing post-strokes in advanced liver cancer. which is one of the most difficult to treat cancer, where there is a high need for tolerable, this is important, and with that effective treatments. And we have seen recent development and advancement in the treatment of liver cancer with the introduction of immunotherapies, and that was as late as 2020. But still, only a minority respond to these available therapies across the treatment line. So if you can see on this slide, in the first line, it is about 30% that respond for around six, maybe seven months in median. When you go to the second line treatment, when they have progressed on the first line, only 10% of the patients respond. And there is actually no approved treatments available after what is currently standard of care. And in this population, that's where we initially are targeting the development of post-trugs. You can go to the next slide. So now we are currently in a very exciting phase with post-trugs in our ongoing phase 1b2a study. And we are, as I said, evaluating FosTrox in liver cancer, and that is in combination with a kinase inhibitor, a TKI, named Levima, in the second line. This study is an open-label, single-arm study, where we have included 21 patients. The study is fully recruited, and we have seen a couple of interim results, and they have been promising, and one of the key elements Of course, response rate and duration of response and all of that is important. But we can also see that the patient benefiting from this treatment and staying on the treatment is longer than we have actually anticipated originally. So we are going to have an upcoming Congress presentation of this study, and that will be at SOGI in June in Munich. And I will talk a little bit more with a couple of slides that is coming up about the latest data that continues to be encouraging. And we have seen efficacy improving and the tolerability remains good. So we can go to the next slide. So looking at the number of patients that has responded on the treatment, we are seeing a higher response rate than what has been reported in the second line Remember, there is no approved treatment of the current standard of care. So we see about 24% in this study and the expectation is around 10% with available treatments. In addition to this, and you can see that on this plot, hopefully, is that over 75% of the patients have a tumor that is shrinking, which is of great importance in liver cancer. where also those where you more or less can control the tumor, meaning that it stays stable, is considered as having a clinical benefit and they can continue on the treatment. Coming back to this, what is also important is how long the patients actually are able to stay on treatment with a clinical benefit. So we can go to the next slide. So in this study, seven patients are still on treatment in the study, where the one has been longest on the treatment is now exceeding 1.5 years, one and a half year. The median time to progression has improved to seven months, which is considerably longer compared to the around three and a half months that has been seen in the second line with available treatment alternatives. So very encouraging data. But we can go to the next slide. But efficacy is really dependent on that a new drug combination is safe and tolerable. And with FosTrox added to Lendvima, the improved clinical benefits that I just showed you has not come with any new unexpected safety events. And the side effects that we have seen has mainly been temporary and hematological. that has been manageable so that two out of three patients have been able to stay on the full dose of Fosdrops without any dose modification. This is important, right, because you want the patient to have as much efficacy as possible. Only one patient has discontinued Fosdrops due to any side effects. And in addition, because we are combining with Lendema, there have been no additional Lendema-related adverse events. why the combination seems to be tolerable. So we can go to the next slide. So with the promising data in this study, the current phase 1b2a study, together with a high unmet need in liver cancer, where nothing, I know I already said that, but this is really important, nothing is improved in this patient population that has progressed on first-line standards. We are continuing to accelerate the development of Ostrox. And in the planning of the next study that you can see here, which is a randomized phase 2b, we are having continuous discussions and advice taking with and from global clinical experts. And recently, as Jens already said, we had a meeting with the FDA. The feedback from the FDA resulted in an enhanced study design that you see here on this slide. It has a similar size and the time estimate as the previous shown study design and overall FDA was supportive on the general design and agreed again that Lenvima is a rational combination partner and is the rational control arm in the randomized trial. So the change that you see here includes the addition of two FosTrox arms instead of one arm in a run-in phase. And that will satisfy the need when we introduce, which we are, a new formulation of FosTrox, and that is for future commercial use. And this is this dose-to-dose arm. is also something that is recommended by the FDA in a project called Optimus that FDA is driving to really optimize the dose that you are choosing. The dose arm that is not selected, because there will be a selected in the 25 first patients that are randomized in three different arms, the dose arm that is not selected will be dropped before going into the main study with around 100 patients the active arm with FosTROX plus Lemnema and 50 patients in the control arm with placebo plus Lemnema. We have also changed the primary endpoint to ORR which has been used for other accelerated approvals in the second line setting in liver cancer and this will later be confirmed in a study where overall survival be included as the primary endpoint for the final approval. So this is pretty much sort of where we are right now, and we are very encouraged by sort of going forward with this. And with that, I'll leave it to Jan.

Thank you, Pia. So take home message is what we have said before in terms of plans moving forward. And we have shown this slide before. So that plan stays the same. no change apart from then sort of the two incorporated study design changes. So in terms of moving forward towards Phase 2b, we are well underway preparing for the next study. I've highlighted in green here in the middle a couple of the elements where we have seen sort of progress during first quarter. One, as Pia outlined, we have had sort of FDA engagement to confirm that Yes, we are moving forward with sort of the same overall plan. And next step will be to sort of finalize study protocol and finalize things for submitting an IND. The other elements also in the middle, we haven't talked so much about it, but in terms of making progress, in terms of moving forward with speed, selecting a CRO is an important element, and that has been progressing very nicely. and will also enable us to kind of start study in the early days of 2025. And we will communicate sort of selection of partners who will we work with as we finalize the agreement. And then also we are, as data are looking stronger and stronger, We are looking forward also a congress presentation data update at one of the more important GI congresses, which is the ESMO GI congress towards the end of June. So again, continued progress in terms of our activities as we accelerate towards phase 2b. Pia touched on the large unmet need, and it took a worthwhile commenting upon that. We know that it's difficult to treat. It is the third leading cause of cancer death worldwide. It is increasing, and the increase of HSE is perhaps possibly underestimated, because what we see is that on the back of the obesity pandemic and fat delivery, expected to increase quite drastically, and that is in the West, but also in the East. And there are no approved treatments in second-line post-IO combination. And there is relatively little development going on in that space. Most of the other companies are focusing on first-line treatment or earlier, leaving an open space for a new combination like FosTrox and Levima. So the total market potential will be sort of above 2.5 billion as we get to 2030 and onwards, and with a significant chance for FosTrux to be the first approved treatment in this patient population. So to summarize things, FosTrux is a smart chemotherapy, selectively killing cancer cells in the liver. The outcomes that we are showing, and please remember that 30% of patients are still on treatment, but even with that, outcomes are improving. At current latest data cut, we are doubling the response rate, at least of what we've seen in previous second-line studies, and doubling of the time to progression. So results that you would normally see in first-line, we are now showing in second-line patients. opportunity of into a market worth two and a half billion dollars. So with that, we'll stop regards to FosTrox and we will move into progress in other parts of the business that we have announced as of late. And the first one being sort of movement regarding MIB 711 granted rare pediatric disease designation in a pediatric disease we haven't talked about before. But I'll hand over to Fredrik to talk a little bit more about this.