Welcome to Medivir Q3 Report 2026. 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 pound key five on their telephone keypad. Now I will hand the conference over to CEO Jens Lindberg. Please go ahead. Thank you, operator, and welcome everyone to Medivir's teleconference covering the third quarter of 2026. Quarter three has been a quarter of focused execution. The external news flow, as you've seen, has been relatively quiet, and I will explain today why that is fully in line with our plan. FLEX-HCC, a randomized phase II study with fostrox in second-line liver cancer, is recruiting according to plan, and preparations for the proof-of-concept studies with MIV-711 in osteogenesis imperfecta and Perthes disease are progressing well. Our out-license program projects have taken important steps forward. With the directed share issue that we completed in July, all three phase II studies are funded, and our cash is assessed as sufficient at least into 2030. Before we start, please note the important notice on this slide regarding forward-looking statements, which applies to today's presentation. With me today are Pia Baumann, our Chief Medical Officer, who will take you through fostrox takeaways from the recent scientific congress, ESMO, and MIV-711, and then Patrik Norgren, our CFO, who will cover the financials. Fredrik Öberg, our Chief Scientific Officer, is also with us here in the room and available for questions. Let's start with the three things we would like you to take away from this quarter. In short, Q3 has been a quarter of execution. First, our programs. FLEX-HCC, a randomized phase II study comparing fostrox plus lenvatinib with lenvatinib alone in second-line advanced liver cancer, is recruiting according to plan in Korea, and preparations for the proof-of-concept studies with MIV-711 in both OI and Perthes disease are progressing well. Second, our out-license projects are taking key steps forward. Vetbiolix's phase II study with MIV-701, or VBX-1000 as they call it, in dogs was almost fully enrolled at the end of the quarter on September 30. Both Biossil, our partner for remetinostat, and Infex Therapeutics, our partner for MET-X, have made important progress as companies. Third, our financial and IP position. We concluded tranche two. It was approved by the extraordinary general meeting on July 20, and the directed share issue was completed. Through the three capital raises that we have now done since December last year, we have raised SEK 336 million before transaction costs, and we are funded at least into 2030. Importantly for fostrox, we received the U.S. Notice of Allowance for the fostrox plus lenvatinib combination patent, which, once granted, provides protection until at least April 2041. Before Pia takes you through the programs, I want to put the quarter into context. If you look at the news flow, Q3 has been relatively quiet. That is not a sign of lack of progress. It is exactly what our plan looks like at this stage. Over the past year, we have completed the first step of the plan, and through three capital raises since December, we have raised SEK 336 million, and all three phase II studies are funded, and our cash is assessed as sufficient then at least into 2030. We dosed the first patient in FLEX-HCC in May, and the study is recruiting according to plan. The phase I-B/IIa data were published in Clinical Cancer Research in June. We are now in the second step in terms of execution, as mentioned. The study, FLEX-HCC, is recruiting according to plan, and preparations for the proof-of-concept studies with MIV-711 are also progressing according to plan. For Perthes disease, the pediatric formulation activities are moving forward very nicely. At the same time, our partners, Vetbiolix, Infex, and Biossil, are advancing their programs, and as you know and as we have communicated before, at no cost to Medivir. The milestones we will receive, for example, from Infex, are of the more modest kind, but it is more importantly a very clear sign that the project is moving forward to initiation of a clinical study and that the partnership between, in this case, Infex and Venus Remedies in India is working well. The third step is delivery. Readout from FLEX-HCC expected during 2027. The start of the proof-of-concept studies with MIV-711 are coming up, and we see progress in our partner programs. This is where the major value inflection points lie, and our job now is to get there according to plan, and hopefully as quickly as possible. This is our pipeline, all programs, all of them targeting patient populations where there is no approved treatment today. We focus on the two green ones in terms of in-house development, fostrox and MIV-711, whereas our partner programs are moving forward at the hands of our partners. I think we wanted to highlight one element being Biossil, our partner for remetinostat, and the agreement we signed last year in November. They have just recently raised a significant amount of money of $153 million in a financing round led by OpenAI Startup Fund. Clearly, not all of that money will go towards remetinostat, but it equally clearly will enable them to drive that program forward. The MET-X project is also moving forward towards the first clinical phase I study in India and triggering the milestone payment that we informed about in the quarterly report today. Regarding Vetbiolix's phase II study with MIV-701, it is almost fully enrolled. We received some questions on that today, and I will come back to that study after Pia's section. Again, in all partner programs, we carry no development costs, but we do retain a meaningful financial upside. With that said, I will hand over to Pia. Thank you, Jens. I will start talking about fostrox, and we can go to the next slide. I just wanted to very short go through the scientific rationale for fostrox in HCC, the clinical data we have, and what FLEX-HCC will provide that Jens has already talked a bit about. Fostrox, you have already heard this, you can just close your eye now, but just to level set this, so everyone understand what a drug we have. It's an oral prodrug designed for liver cancer. It's activated in the liver, which means that we deliver the active substance, which is troxacitabine, where the tumor is, and keep systemic exposure low. Biopsies from our phase I-B/II-A study has confirmed this, where the DNA damage is in the tumor tissue, and we couldn't see any DNA damage in the surrounding healthy liver tissue. This means that we are sparing the important liver function to continue that way. In the phase I-B/II-A study, 21 patients with advanced HCC, most of them previously treated with atezolizumab plus bevacizumab. They received fostrox plus lenvatinib as a single arm treatment. As a clinician, what I found is most convincing is really the consistency of the data we got from this study. The objective response rate was 24%, median time to progression 10.9 months, and a median overall survival of 13.7 months. It all pointed in the same direction. About what has been reported, it was clear what has been reported in previous second line studies. The combination was well tolerated also, and only one patient discontinued due to adverse event. Very important as well is that we did not see an increase in the lenvatinib dose reduction compared to what has been reported with the monotherapy treatment. What is FLEX-HCC, our ongoing study, will do in this program? First, I would say that the enrollment in FLEX-HCC is according to planned timelines. The plan is to randomize 80 patients with advanced HCC after immunotherapy, and they will receive fostrox plus lenvatinib or lenvatinib alone. The primary endpoint is response rate, and we have already heard that, but the estimated readout is planned during 2027, so next year. What FLEX-HCC will provide is that it will be the first randomized data set for fostrox, showing whether the efficacy and safety data point really in the same direction as we saw in the phase I-B/II-A, and whether fostrox adds efficacy on top of lenvatinib without adding any toxicity. Those data will really form the basis for registration and study. Importantly, again, here in to understand the treatment algorithm, what the patients have access to, there is still no approved treatment in the second line advanced liver cancer after immune therapy. So the need is still very high. You can go to the next slide. We have talked a bit about FLEX-HCC, but I think it's important to put this study in the context of our development strategy for fostrox, because it's important to understand what this study is designed to deliver. The phase I-B/II-A study gave us a consistent efficacy signal across response rate, time to progression, overall survival, as I just mentioned, and it was well tolerated. We found also the recommended phase II dose. FLEX-HCC is the next step. It gives us the first randomized comparison of fostrox plus lenvatinib against lenvatinib alone. It is run by an experienced research consortium in Korea with an estimated readout during 2027. What we are looking for in FLEX-HCC is the direction and the consistency that the response rate, progression-free survival, time to progression, overall survival, all point in the same direction as in the phase I-B/II-A, and that fostrox adds efficacy on top of lenvatinib without adding toxicity. That is the evidence that matters for the next step. The FLEX-HCC data will really form the basis for a registrational study. It will also give us advice on the design, what endpoints we should have, patient population and size, and obviously for our dialogue with regulators, and very important for discussions with the potential partners. FLEX-HCC is the gateway to partnering and a registrational study, and which will take us into pivotal development towards becoming the first approved second-line treatment after immunotherapy. Can we go to the next slide? Last week was a busy week. We attended ESMO in Madrid, and as always, we did not only listen to the scientific presentation, but we also took the opportunity to discuss about the new data that was presented with investigators and experts to better understand what we need to consider in the development of fostrox. These are the key takeaways, and the short version is really that the second-line opportunity for fostrox plus lenvatinib remains, and our strategy is unchanged. The treatment landscape is stable. Immunotherapy combination remain the first-line standard, and lenvatinib remains as the preferred second-line treatment. The LEAP-012, if you saw that, it showed no overall survival benefit when lenvatinib was added to pembrolizumab plus TACE, and that was an intermediate-stage HCC. This is important not to sort of have this systemic treatment already in intermediate stage, so we can ensure that this first-line immunotherapy combination remains in the first line. A discussed topic at ESMO was GPC3 and the bispecific antibody BGB-B2033 from BeOne. The data are promising, but at the same time, the data are early, with a median follow-up of only 5.5 months. We didn't see any data of progression-free survival or overall survival, naturally, since they had a very short follow-up. In addition, two important question remained from the presentation, and that is, what is the cutoff that defines GPC3 positivity? What happens to the expression of GPC3 during a GPC3 targeted treatment? There are a couple of questions still remaining. We know that BeOne is starting phase III studies across line of treatment and also across clinical stages. It is a very ambitious program. However, their clear strategic aim is likely to be in first line, where they want to use the synergy, meaning that the GPC3 expression gets upregulated during anti-PD-1 treatment. They want to combine probably with their own anti-PD-1, tislelizumab, and get approved in the first line. This is what we strongly believe. What does this mean for us? There is still no approved second-line treatment after immunotherapy, and the medical need remains. With GPC3 bispecific likely moving into first line, second line after immunotherapy remains open for fostrox plus lenvatinib. Also, with improved first-line treatments, more second-line patients will be eligible for systemic treatment, which means that fostrox plus lenvatinib population probably will expand. The experts that we met at ESMO continue to see the strong potential with fostrox in combination with lenvatinib in the second-line setting. Our strategy for fostrox plus lenvatinib is therefore unchanged. We plan that delivery of the FLEX-HCC will be during 2027, and that will be really the basis for the registrational study. Thank you. We can move to the next slide. Let's move into MIV-711, where we are developing one molecule into two rare bone indications, both without any approved drug treatment today, and preparations for both of these proof of concept studies are progressing according to plan. I will start to say a bit about one of them, osteogenesis imperfecta. We can go to the next slide. Just as a reminder, osteogenesis imperfecta, or as it is called, brittle bone disease, is a rare genetic disease. It is about one in 15,000 births, and it is caused by defective or insufficient collagen production. The result is fragile bones that fracture really easy, and this results in deformities, short stature, in chronic pain, and there are approximately 500,000 patients globally that is affected by this disease, and no approved disease-modifying treatment is available. The study on this slide, that you can see on this slide, is our randomized phase II proof of concept study, where approximately 20 adult patients with OI who had fracture within the previous five years will be enrolled. They will be randomized one-to-one to a high or to a low dose of MIV-711 and treated for 12 months. The endpoints are change in bone biomarkers, which includes bone mineral density. We will also look at pharmacokinetics, safety, and number of fractures. The preparation for this study are progressing according to plan. We have five sites preselected, and the eligible patients are largely already known to this hospital, which support fast enrollment. The preparation of clinical activities is also well underway, and manufacturing of study drug is on schedule, and we continue to see strong commitment from patient organizations. We can go to the next slide. Looking at MIV-711 as a whole, the work this quarter, as Jens Lindberg already mentioned, has been focusing on execution, and here, the manufacturing and the formulation side. Manufacturing of MIV-711 is progressing according to plan, and for Perthes disease, a pediatric oral formulation is a prerequisite for the proof of concept study. We are following thorough evaluation, and the remaining step is to select the partner before the formulation work begins. The aim is one pediatric formulation that can serve both the Perthes disease and the osteogenesis imperfecta when we can go into the pediatrics there. The foundation of the program is really unchanged. A third-generation, highly selective cathepsin K inhibitor, where we have seen radiographic benefit in around 250 subjects in phase I and II in osteoarthritis. Proof of concept in disease-specific animal models. We have Orphan Drug Designation in both indications and Rare Pediatric Disease Designation in Perthes disease. With that, I hand back to Jens Lindberg. Thank you. Just before we touch on MIV-701, just putting it together again, three phase II studies that we are running, planning for, all fully funded, and all of them carrying a very clear and distinct value inflection point with FLEX-HCC, the randomized study that has progressed the furthest, with the top-line readout in 2027. Again, through the three capital raises since December, with SEK 336 million, with the support of both existing and new shareholders, we are well-funded with cash sufficient at least into 2030, meaning we can focus on execution. Before I hand over to Patrik for the financial numbers, a couple of notes on MIV-701 or VBX-1000, which is our cathepsin K inhibitor out-licensed to the French company Vetbiolix for veterinary use, where they are developing it for periodontitis in dogs. One of several projects moving forward in the quarter. Just to circle back to information that we provided before, this is the randomized placebo control study Vetbiolix is running with the VBX-1000 or MIV-701, with client-owned dogs with alveolar bone loss in periodontal disease are randomized to three arms. There is a high dose and a low dose of the study drug versus placebo. Endpoints including bone resorption and biomarker CTX and bone loss, et cetera. At the end of quarter three, i.e. September 30, 40 dogs had been enrolled toward a target of 45, so the study is almost fully recruited. We have gotten a couple of questions, and we have previously communicated a target of 51 dogs, so let me explain the difference. The study is designed to have 45, i.e. 15 dogs in each arm, 45 evaluable dogs for the analysis. The earlier figure of 51 was the number of dogs to be recruited, including an allowance for expected dropout. That is a standard operating procedure in clinical studies, and that is the number Vetbiolix originally communicated, the 51. Going forward, we will communicate, and they are communicating the number that matters for the analysis, i.e. 45 dogs. So there is no change to the study design. There is no change to endpoints or the planned analysis. There is no difference compared to previous. Just as a reminder, periodontitis affects around 80% of dogs over three years of age. There are no approved drugs that can stop bone loss today. Under the agreement, we do retain a financial upside without any development costs of our own. If the study confirms the earlier proof of concept data, it would be transformational, clearly for Vetbiolix, but also with a substantial commercial upside for Medivir through royalties and a significant share of any partnering income. So we are, as they are, at the end of the quarter, almost fully enrolled. We are eagerly looking forward to the top-line results of this study. With that, I hand over to Patrik for the financial details of the quarter. Thank you, Jens. I will present the financial summary for the third quarter 2026. The net turnover for the third quarter was SEK 0.7 million compared with SEK 0.9 million last year, reflecting lower royalty revenues. The operating loss for the third quarter was SEK 17.1 million compared with SEK 13.6 million last year. This is mainly due to that the other external costs were SEK 12.7 million compared with SEK 8.1 million last year, an increase related to higher costs for clinical studies. However, the personnel costs decreased to SEK 4.0 million from SEK 5.8 million. The cash flow from operating activities in the third quarter was minus SEK 14.7 million. The cash flow from financing activities was SEK 9.2 million, mainly reflecting tranche two of the directed share issue, which was approved at the extraordinary general meeting on July 20. The cash balance in the end of the third quarter was almost a quarter of a billion SEK. Medivir has a strong financial position, and the cash is assessed to be sufficient at least into 2030. That assessment does not include any income from out-licensing of fostrox or MIV-711, nor future revenues from our agreements with Vetbiolix and Biossil. With that, I hand back to Jens. Before we go to Q&A, let me close by looking ahead at our most important value drivers. For our own programs, recruitment in FLEX-HCC, the continued recruitment moving toward full enrollment, with the primary readout next year. Also the sort of site activation startup of proof of concept study for MIV-711 in osteogenesis imperfecta and in Perthes disease, sort of moving ahead with speed on the pediatric formulation activities, so that we can sort of take the next step towards a proof of concept study in that indication as well. For fostrox, we will, of course, continue to strengthen our IP situation, and I think that we've been sort of very successful thus far, and we're very happy to get the U.S. combination patent or the Notice of Allowance in July. Once that is granted, that provides protection until at least 2041. On the partnered side, sort of really nice to see that sort of three of our programs all moving forward in a very good direction with good speed, with Vetbiolix enrolling 40 out of 45 dogs, i.e., being almost sort of fully enrolled by the end of the quarter. Again, just to go back to my previous one, no change whatsoever to study design or what the analysis will look like. So 40 out of 45 evaluable dogs enrolled. Biossil is preparing its first clinical study with remetinostat, and they are well-financed to do so after its sort of $153 million raise in September. Last, we saw Infex or MET-X program moving forward, triggering a new milestone to Infex, also then triggering a modest milestone to Medivir. In all three of these programs, no development costs, but significant financial upside. That concludes our presentation. Thank you for listening, and I think, operator, we can now open up for Q&A. If you wish to ask a question, please dial #5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial #6 on your telephone keypad. The next question comes from Richard Ramanius from Redeye. Please go ahead. Hello. Good afternoon. I have a few questions, starting with a financial one. What are your assumptions behind the financial runway beyond 2030? Would be interesting to hear a bit more details on this. I think the key thing to convey and what we have conveyed, and I think that that is where we will stop today, is we have, with the money we have raised, we have the runway and all three phase II studies for the three programs fully funded. In that financial runway, we are not calculating or including any money from partnering activities, any milestones, et cetera. That will clearly be an important element moving forward as well. But most importantly, we can execute all three phase II studies, get the readout, and reach the relevant value inflection points. I think that is the most important element, and that takes us into 2030. All right. For the MIV-701 for dogs, what would your expectations be, or what you think your partner would do upon positive results in terms of deal-making, and what could that mean for Medivir in terms of near-term and long-term income? There's always a risk that it becomes a bit speculative, but Vetbiolix, what we can say is clearly Vetbiolix is not a big company. They are a relatively small company. They are running two sort of close to pivotal programs, which they are doing in a very nice fashion. But are they sized to sort of take programs forward towards commercializing, et cetera? No, they are not. We know, and they've already communicated that themselves externally, that they are in discussions with the big veterinary players. There is a strong interest in the program because periodontitis, this would be the first disease-modifying drug in a very, very common disease. So clearly has a very significant commercial upside, generating the attention of all the big players. They have that discussion with them. The bigger companies have also, again, communicated by Vetbiolix. They have also been very clear to them that they are not looking to do any partnering before randomized data, so that the study they are now running and the top-line results we are looking forward to in the near term is what those partners are looking for. I think that, again, we don't know what they will do, but following on positive top-line results from this study would be the quite natural sort of point for them to partner, out-license, or whatever sort of step they take. That would be logical for the company of their size. Then, just to sort of then, you asked sort of what does that mean for us? We have no milestones to talk about sort of in the deal. All our financial upside is through revenue sharing, and that's how that deal has been structured. We do have a very healthy sort of share from a revenue-sharing perspective. Hence our comments that sort of this is where we see a significant commercial upside. So if they were to partner, that would be commercially very beneficial for Medivir. All right. That is very clear. Thanks for answering my questions. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Klas Palin from DNB Carnegie. Please go ahead. Hi there, and thanks for taking my question. This is probably the obvious one that you are not interested in perhaps to answer, but I will do this anyway. I just wonder if you have any comments about the enrollment in the FLEX-HCC study more than according to plan? You know what I am going to answer more or less. It is progressing according to plan at this 12 site in South Korea, and we expect all the patients to be included within this 12 months that they had in the planning. As you know, we do not report patient number quarter by quarter, but we will communicate when the enrollment is complete. The expectation is that there will be a primary readout in 2027. That is what we can say at this point. But is there any, I mean, you noted competition when it comes to clinical sites in HCC in Korea? Yeah. I mean, we saw the data at ESMO, and we have recognized that this GPC3 bispecific is starting clinical trials. As I already said, the data are promising, but they have a very short follow-up. We know that they are planning quite a few clinical trials, but we do believe that their main interest is in first line. Even if there will be competition also in the second-line setting, this study that is ongoing, the FLEX-HCC, has been going on since May. I mean, that's not that far away until it's fully enrolled. Hopefully it will not impact the enrollment in the study. But we will continue to follow this. As we've said, I mean, it is progressing nicely according to plan, so we haven't seen any signs of any competition hindering us to date either. Yeah. Okay. Last then, if you could provide information about costs going forward. I guess you are entering a period with more activities, so maybe we should expect costs come up a little bit from compared to Q3? I mean, as we move towards a proof of concept study in OI, as you get to a point where you initiate the study, there will always be upfront costs for starting up activities and CMC activities. Yes, I would anticipate positively a bit more cost because of that. With regards to fostrox, I think no. Then we've actually, the way we structured it, we have taken a reasonable chunk of that cost already. Not anticipating that to go up, if anything, in the other direction. It's not that I'm We're not looking for We're not anticipating a major increase, but clearly with the OI study, that will trigger some clinical and CMC costs. Okay. Great. Thank you so much. That was all for me. There are no more questions at this time. I hand the conference back to the speakers for any closing comments. Okay. Thank you. Before we close the call, let me come back to where we started. We emphasized that quarter of execution, i.e., the news flow, very clearly we always want to come up with as much exciting big news flow as possible. This one has been relatively quiet, but that's been a good quiet this quarter. It's been fully in line with our plan. With funding in place, we're focusing on moving all the projects forward. As we mentioned, we've said it many times, and we'll end by saying it again, the FLEX-HCC study, our lead program, recruiting according to plan. What we heard at ESMO confirms the opportunity for fostrox in second-line liver cancer. Our strategy is very much unchanged, and the preparations for our other two proof of concept studies are progressing well. Out-licensed projects, really exciting to see that all three projects taking steps forward in a single quarter, with the Vetbiolix top-line results around the corner. We are eagerly looking forward to that outcome, which does have a transformational potential for transformational impact on Vetbiolix, but also a significant upside for us. With the SEK 247 million in cash, funding at least into 2030, and the IP strengthened, we feel we have what we need to reach the value inflection points ahead of us. With that, I would like to thank our shareholders for their continued confidence. Thank you everyone for attending today's call, and have a great rest of the day.
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