Welcome to Medivir Q1 report 2026. For the first part of the conference call, the participants will be in listen-only mode. Now I will hand the conference over to CEO Jens Lindberg. Please go ahead.
Thank you, operator. Welcome everyone to the Medivir Q1 2026 results webcast. We look back at a transformative quarter, where we've strengthened our financial position. We've opened up a new rare disease opportunity with MIV-711, and we just came back from a successful and quite invigorating trip to Korea, where we visited a number of the highly engaged hospitals and investigators now sort of eager to get going in the FLEX-HCC study. Pia will share more on that particular topic in just a little bit. We've also seen our partner Vetbiolix in France make great progress in the past quarter, so we are looking ahead to the remainder of 2026 with great anticipation.
As mentioned, we've just come back from Korea and the interest in the FLEX-HCC study is very strong among the hospitals, and the interest to participate in the study is quite high. The Korean Cancer Study Group, they have added four additional hospitals in the quarter. The interest as we were sort of visiting them was quite palpable when we had the opportunity to meet with eight of the hospitals face-to-face. We also do understand that sort of perhaps the greatest interest, however, in the study is when is it starting. We're happy to be able to convey today that we've just sort of gotten news that the first two sites are now open to start enrolling patients. Our trip to Korea came at a perfect time.
We're able to engage with them just about as the study is about to open and they're about to start enrolling patients. We have also spent quite a bit of time in the last quarter of engaging externally with clinical and regulatory experts, as well as patient organization in the field of osteogenesis imperfecta to kind of confirm and finalize study design plans for the proof of concept study in the disease. We have been positively surprised by the great interest and willingness to engage across sort of all the stakeholders.
Perhaps most importantly, those interactions have led to some adjustments in our plans, the overall plan is sort of laying firm, and we've been sort of strengthened in our belief in the potential of MIV-711 in osteogenesis imperfecta. Finally, as I mentioned, our partner Vetbiolix continues to rapidly progress their clinical efforts with MIV-701 or as they call it, VBX-1000 for periodontal disease in dogs. As of end of April, they have now recruited more than 40% of the subjects in their ongoing study to confirm that MIV-701 has the opportunity to be the first disease-modifying treatment for the disease, which is a critical step to unlock the blockbuster potential of the drug.
They, we and they expect results in Q4 this year. That sort of will be a significant potential inflection point for the program and then also for us, of course. Today, we will focus on those. These are our programs. As you can see, sort of the in-house programs at the top, Fostrox for liver cancer and MIV-711 for osteogenesis imperfecta. We will touch more on those two programs today and the progress we've made, and we'll also sort of touch on the outlicense program to Vetbiolix, hence those that are marked in green.
One minor comment to make regarding one of the other programs, and that is remetinostat, is that following on from us making the agreement with last year, the Gorlin Syndrome Alliance, which is a not-for-profit organization in the U.S. supporting patients, families, and healthcare providers, they have sort of actively reached out to us and then to Biossil, eager to, sort of as they heard of the news, eager to support the development in patients specifically with Gorlin syndrome. Gorlin syndrome patients are sort of genetically driven disease, and that manifests predominantly as patients get multiple sort of BCC lesions, where surgery is many times not sort of a good option.
For them, development of remetinostat in that particular rare disease subpopulation is critical, and that's also our understanding from discussions with Biossil as they license the drug that that might well be sort of their first development path. Interesting to see interest in that drug as well, and we look forward to hearing more about their plans as we move forward. Today, I am joined by our CMO, Pia Baumann, our new CFO, Patrik Norgren, who joined us sort of just a month back-ish, and then our CSO, Fredrik Öberg. With that said, let me hand over to Pia to share an update on our efforts with both Fostrox as well as MIV-711, including then our recent engagements on the ground in Korea. Pia, over to you.
Thank you, Jens. Thanks for the introduction also about sort of what has been going on when it comes to Fostrox. Just as a reminder, the FLEX-HCC study, that is the reason why we went to Korea, is a randomized second-line study in liver cancer, and it's really there to strengthen the evidence that we have from our single-arm trial with Fostrox + LENVIMA in liver cancer and to show superiority over LENVIMA alone. Just as a reminder what this study is, it is like Fostrox is combined with LENVIMA in one arm, and it's randomized against LENVIMA monotherapy in the other arm. It will be 80 patients that will be enrolled in this study, and they should have progressed or be intolerant to prior immunotherapy combinations.
As Jens said, the patients will now be enrolled at 12 sites instead of the original 8 sites due to the fact that it was a high interest. The PI for the study is Professor Jeon from CHA Bundang Hospital, and he is doing this study in close collaboration with the Korean Cancer Study Group. I think that is also the reason why it is a high interest because this group recently executed and also published actually the only prospective study with lenvatinib monotherapy in a similar patient population that will be enrolled in the FLEX-HCC study. It's a really, really nice setup.
Here the patient enrollment is expected to take around 12 months, and the primary endpoint will be evaluated by a blinded independent central review to make sure that we have the quality that is required to really show this difference. Since we hope this study will enroll and perform relatively quickly, the top-line results is expected already in 2027. We had the opportunity to visit eight of the 12 sites last week in Korea. Right now, two of the sites are open for enrollment, and that is CHA Bundang, where Professor Jeon is situated, and Severance Hospital. We know that they are super eager to have the first patient in.
As you can see on this map here, if you can see it, the sites is geographically spread across Korea also to have the best chance of capturing all the patients that could be eligible for this study. Since we had the opportunity now to discuss with the investigators, it became really, really clear that there is a very high interest in participating in this study, and that they have quite a few second-line patients every week that potentially could be candidates to be enrolled. Overall, the support for the study and the PI, Professor Jeon, was overwhelming, and it confirms really the expertise and the quality his name is associated with when it comes to liver cancer studies.
Overall, we were very welcome, and they were extremely interested in Fostrox, also as an alternative with another mechanism of action, compared to both immunotherapy and TKI that is usually the one that you can use in this patient population. We can go to the next slide. To summarize the takeaway from this visit, we can conclude that unfortunately, liver cancer continues to be a very common disease in Korea. Despite that they now have started vaccination, it's still very common. That, while there are treatment option in first line now with immune combinations, primarily, there is a high unmet need in subsequent treatment line, particularly in the second-line setting where the patients, many of them, can tolerate a second-line treatment, but still there is sort of no optimal treatment.
The sites are fully committed to the FLEX-HCC study, and it fits very well in with a standard treatment for advanced HCC. The majority, 80% something like that, will have received TECENTRIQ + Avastin, the immune combination in first-line, and almost all of them is trying to have LENVIMA in the second-line setting. That's why this trial really fits well in. Most of the site had no competing studies ongoing in HCC. Those who actually had studies ongoing, it was mainly cell therapy or bispecific targeting GPC3, which I think that all of you are interested in HCC have heard about. It has been a target that has been discussed for quite a few years now, and we are waiting for the results. It's mainly in the first-line population and selected patients there.
The interest in Fostrox is also part built on the fact that it is an all-comers population. You don't need to do any biomarker testing, and it could be something that is available for more patients than those who are selected in the other GPC3 trials. High interest. We can go to next slide, and I think I'll leave it to you, Jens.
Just to sort of summarize, I mean, I think first and foremost that we were sort of highly encouraged. It's always good to meet face-to-face and sort of see that engagement commitment. Now with CHA Bundang Medical Center and Severance Hospitals just now in open for enrollment with the other hospitals to follow sort of shortly, it feels quite good, and we're very much looking forward to the progress. With their engagement, sort of also looking forward to sort of speed of recruitment. For everyone, just to sort of summarize again, we do have the first and only liver-activated small molecule targeting, selectively targeting tumor cells in the liver, sort of sparing healthy liver cells. That's also sort of clearly from some of the hospitals we've met new physicians.
Sort of as we go through the drug in a bit more detail than I've seen before, it is one of those areas, sort of one of the features that they appreciate the most. We continue to move forward, and as Pia said, there has been very little development in second-line, very little competing studies. Again, our aim eventually, to the right, is to hopefully become the first sort of approved second-line treatment in advanced HCC, a market that is conservatively valuated at sort of $2.5 billion per year. With that, and on the note of hospitals sort of opening up, we move to the second program. Let's talk a little bit about sort of what has happened with MIV-711 since we last spoke. Pia?
Yeah. For MIV-711, we are aiming to do a proof of concept study in osteogenesis imperfecta. Since we really need to have advice both from the scientific community, but also from other parts, we have first and foremost formed a scientific expert council, and they will provide advice, and they have already provided advice. We have had our first advisory board and feedback on the development path and also on the study design. The study design now initially for the planned proof of concept phase II study. The members of this council are highly renowned global experts. I'm sorry?
No. Go ahead.
Okay. Highly renowned global experts in osteogenesis imperfecta, and they have a background as many of those working with OI has. A endocrinologist, internist, rheumatologist, and we also have a pediatric endocrinologist, part of this advisory council or the scientific expert council since that is sort of where we aim at eventually since this is a genetic hereditary disease that affects the patients already from the childhood. All of them in this council have a vast experience in clinical study design, in translational research, and also in preclinical research. They have been part in centralizing the treatment and where the OI patients are taken care of at the hospital.
They have also been part of developing systemic treatment, which is sort of I think that we talked about it potentially last time, those who have not been successful, when it comes to the primary endpoint, the anti-sclerostin, and they have been part of that development as well. We are trying to take as much experience as possible from earlier treatment program to understand how we are going to be successful in the first part of a development for OI. Obviously, their expertise and advice will be crucial to finding the optimal study design and also to find the sites where we can enroll patients, and in addition to that, provide the context of how the standard of care for these OI patients, how it looks like.
This is a very schematic draft design of the phase II randomized proof of concept study that we are showing you so far. It will enroll patients that have experienced at least one fracture during the last two years, and they will be randomized one-to-one into a high or into a low dose arm of MIV-711. MIV-711 is an oral treatment. It is a once daily treatment. We can come back to that, but this is something that is really important for the OI patient as well, that it is an oral treatment and not an intravenous treatment because they have seen the inside of hospitals their whole life. This is a very positive part for them as well.
The endpoints will include biomarkers of bone resorption and also measurement of bone mineral density. The proof of concept will be built on these two, but also other endpoints will be looked at, obviously PK safety. We will also evaluate the number of fracture, even if the follow-up time, it's not gonna be probably long enough in this study, but it will at least give us some idea. Enrollment will be in Europe, and since these patients are already known at the sites, since they have been identified already when they are children, most of them, we expect a really fast enrollment. We are currently working on finalizing the study design. In addition to our scientific expert council, we have contacted other important forums for advice. These forums include some of them we see here.
We, it's representing regulatory and patient organization. First, you can see here we met a former FDA regulatory expert that is also a pediatric physician who previously worked in the clinic with OI patients. We received advice on particular filing for rare pediatric disease designation and also the next development step in both adult and pediatric OI since there is a need for treatment in the whole sort of segment of from pediatric to adolescents to adult OI. We also met with the chair of the Osteogenesis Imperfecta Federation, OIFE, to better understand the patient perspective and the general unmet need. In addition to that, we have participated in the annual meeting for the Swedish OI organization, where we had the opportunity to present our development plan for MIV-711 in OI.
That included also the proof-of-concept phase II study design that we have drafted to receive insights from the patients to understand if this is feasible or not, and also to get a little bit more knowledge what is the most important question for them. The key takeaways were that there is a strong engagement from the external experts with a deep scientific support for the specific mechanism of MIV-711, the anti-cathepsin K in OI. There is a high interest in this proof-of-concept study. We also learned that the existing clinical and non-clinical package that we already have for MIV-711, together with a significant unmet need, really support the development in a pediatric population, and that it was confirmed that there is a potential for rare pediatric disease designation with a priority review voucher.
Last, the patient organizations emphasize the significant medical need here, and it is across all subtypes of OI, and it includes also the milder Type 1. They really supported our plan for this proof-of-concept study with MIV-711. As I already said it was more important than we probably realized before we went there, that it is an oral treatment that can be taken at home without having to go to the hospital. Overall, a really positive meeting sequence and important advice. I will leave it to Jens.
Thank you, Pia. I think just to sort of a little bit of a backtracking to sort of the last quarterly call we had. I mean, clearly, as a team, as we are embarking on this type of journey, we have done quite a bit of work on the molecule and in terms of planning. But there's always the element of as you sort of step up your external engagements, whether it being clinical expert, regulatory experts, and you start to deep dive, there's always the worry that sort of how on spot have we been. It's been super encouraging to see that sort of where we have aimed the plans we had.
They've been highly supportive of those plans, worked with us to do some further adjustments and tweaks. Overall, we were already at that time sort of on the right path, and that has been confirmed in the interactions in the past few months, which is highly encouraging. If we look at it from a market opportunity perspective, one other element that has been confirmed is that sort of we are the estimated prevalent OI population, roughly around 70,000 patients across U.S., E.U., Japan, and Korea. The significant unmet medical need across all subtypes, I think that's been a key element because sometimes we've heard indications that maybe the mild Subtype 1, maybe the unmet medical need isn't so big.
That from both experts and from the patients, it's super clear that the milder group have a very significant unmet medical need and in need of new treatment options as well. Confirmation overall that sort of the market opportunity here is of similar size as we see with Fostrox in the advanced liver cancer space. Equal size for the second program. All in all, as we have shown previously, the plan continues to stay the same. There are no treatment-approved options available, sort of, particularly following sort of Ultragenyx failure in phase III in quarter four. Unmet need there.
The potential to be the first approved treatment option in this disease is still there, and we are eagerly looking forward to embark on the phase II proof-of-concept study. With that, just to take a few words as we continue to see progress with Vetbiolix as they are moving forward. Since the last study, they've continued to enroll patients. They've continued to enroll subjects or dogs, more than 40% so far. We eagerly look forward to the results in quarter four.
Just to sort of refresh, from a memory perspective what the drug is doing and what they are targeting, sort of with MIV-711 or VBX-1000, in periodontal disease, it's in development for stage II and stage III, i.e., before the need for surgical removal of the teeth. It is the first disease-modifying treatment in development for periodontal disease, and as such has the potential to prevent significant suffering as well as very costly procedures, such as sort of removing the teeth if the disease progresses too far. As a disease-modifying treatment, if it hits, then clearly has the potential to transform how these dogs are treated, moving forward. No change sort of in the study is just as we sort of shown last time.
Again, targeting out of 51 dogs to be enrolled, already reached 22 thus far by end of April. From a financial, commercial potential perspective, as a company, our upside potential lies in royalty revenues and any share of potential Vetbiolix partnership payments. With more than 70 million dogs in U.S. and E.U. suffering from periodontal disease, the commercial potential is clearly significant. In our estimations, if positive outcome of the program and it gets to market as a disease-modifying treatment, we estimate the potential for us through annual royalty revenues of approximately SEK 700 million per year, after five years after launch.
As we have focused sort of in the agreement with Vetbiolix, we have focused the financial terms on the agreement on upside upon approval and commercialization. With that, I hand over to Patrik for the financial details before we go to Q&A.
Let's go to slide 22. I will present the financial summary for Q1, and all the numbers are in million SEK. As you can see, the net turnover for Q1 was SEK 1 million, which was SEK 0.4 million higher than Q1 last year. Other external expenses were SEK 4.5 million, and the person cost was SEK 5.5 million. In total, the total operating costs were SEK 10 million, which is SEK 3.5 million lower than Q1 last year. It's mainly related to less employees and lower costs for clinical studies. The operating loss was SEK -9.4 million, which is almost SEK 4 million better than last year, Q1 2025. The cash flow from operating activities was SEK -13 million. Medivir has a strong cash position.
The cash balance for end of Q1 was SEK 149.1 million. Yeah.
Okay. With that, thank you everyone for listening to the presentation part of the webcast. Operator, we can now open up for Q&A.
The next question comes from Richard Ramanius from Redeye. Please go ahead.
Good afternoon. I have a few questions. The first one is, when exactly do you expect to dose the first patient in the Fostrox study?
Pia, do you wanna take it or should I take it?
Two sites are open and obviously we are hoping that will happen soon, as eager as they are to enroll patients. I cannot say, but any day now, I would say.
I think that the I mean, clearly we've prepared for it. I mean, drug is on site in Korea as well, so they as they open the sites, as they open for enrollment, they are now ready to start sort of including and initiating patients.
Okay. I was also thinking about the study in osteogenesis imperfecta. What age group do you think you will target in the study you're designing, and what type of disease?
Yes. This is still a draft, but I can say that we are aiming for an adult population in this first proof of concept study. To find a relatively homogeneous population, probably the milder ones. We will come back when we have a little bit more firm study design and when we have received all the feedback that we need.
All right. When do you think the VBX-1000 could be on the market at the earliest?
I think that's a bit difficult for us to speculate on. I think that I would defer that sort of topic more to the animal health experts with regard and Vetbiolix in particular. I mean, we've had discussions with actually the Vetbiolix team to see whether we should organize sort of as we progress our, sort of as the study starts for Fostrox, we progress our plans and we firm up our plans on OI. We would also look to have a capital markets day where we would include the Vetbiolix team. I think that might be a better sort of suited topic for answering that question in a bit more detail.
What I can say in terms of what they've communicated, they anticipate the readout of this study, which is an important one, and that will be a key inflection point for them. They are also anticipating either themselves or sort of a partner, which wouldn't be surprising if they sort of move to an out licensing situation after this study. There is an anticipation of a registrational study as well as the next step before final approval. Timing of that, I would be a bit difficult for me to speculate on, but it's relatively clear that sort of as they run studies, they are able to recruit subjects quite quickly.
Okay. Very good. 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.
Thank you. Thanks for taking my question. Would start with the Fostrox question. Nice to hear that you now have two sites open in Korea. Just a little bit curious, why expanding the number of sites from eight to 12? Is this purely driven by interest or anything else?
Hi. This is collaboration with the Korean study group, which is a natural study group that just performed another study where they had actually 13 sites enrolled. I would assume that there was so high interest that it's a little bit difficult to maybe select those because all of them enroll patients, right? All of them are qualified, and they are in different parts of Korea. It is of interest they have expanded the sites, not that they are worried that it wouldn't enroll fast enough.
Okay. You're sticking to the timeline that you have previously announced?
Yes. I would say, I mean, we can just see how the environment looks like when we are at the sites, but it was encouraging to see how many second- line patients they have. Of course, we can never know if they are eligible or not since they are also a heterogeneous population in HCC. It's very encouraging to see how many patients they have at these sites that we were. I'm not worried about the timelines.
I think the added comment, Klas, is sort of the, and I think as Pia is alluding to, sort of the decision to include four additional sites, that was a Korean Cancer Study Group study decision. That wasn't a push from us with regards to sort of speeding up timelines, et cetera. That came from them. We have an agreement and that agreement was sort of for eight sites, and there is a budget for eight sites, et cetera. This came from them, this is a decision that they took. Sort of, it doesn't sort of add any kind of budgetary costs for us, et cetera.
It purely reflects their engagement and the interest from their hospitals that they felt that, "Okay, we want to include them." For us, we see this as a pure positive. It can only speed up recruitment. Rather than promising a quicker recruitment, we're sticking with the timelines, but hopefully sort of this can contribute to recruiting even faster.
Okay. Perfect. My next question is then related to osteogenesis imperfecta. It relates to your interactions with experts. If you had a chance to discuss a potential primary endpoint for a pivotal study and also perhaps discussing the development that has been seen in osteoporosis where bone mineral density has emerged as a surrogate endpoint.
Thank you. It's a very good question. Yes, we have the possibility to discuss it with them. Just remember now, this is the first study we are doing as a proof-of-concept study. Bone mineral density is what you can use for that study together with other biomarkers for bone resorption, so to see that our hypothesis holds. When it comes to the primary endpoint for a pivotal study, it is of huge interest also for the whole OI community and for everyone who is developing anything in this disease since the FDA has required previously to look at annual fracture rate. We talked about this before. Ultragenyx's study didn't was not positive when it came to annual fracture rate.
This is something that is concerning obviously for the OI community since they want to have an approved drug. This is a discussion that I know is going on with the regulatory authorities, also with the OI community. So far I haven't heard what that endpoint could be if not annual fracture rate. When it comes to bone mineral density, it is an approved endpoint in osteoporosis, and I think we have said that before as well. You could potentially consider OI, and particularly in the adult population, as osteoporosis on steroids, with the same sort of amount of bone mineral density loss.
I think it, depending on data you can show also in the future where you can validate the bone mineral density against the fracture rate, I think that is going to be important. The collective new data will potentially contribute to I don't know if it's ever going to be a surrogate endpoint for OI, but we have. Now, now I'm saying several things at the same time. I hear myself. It is a good endpoint for showing proof of concept. It has also been shown that, for example, for bisphosphonate, that even if you increase the bone mineral density, you have not shown that you reduce the fracture rate. I think that is sort of the base for not having this endpoint accepted in OI.
If you can show that you still have bone remodeling, which we hope to show with MIV-711, and you actually can see that you are at least having some kind of effect on the fracture rate, maybe it will be a possibility in the future.
Okay. Okay. Thank you so much. That was all for me.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Thank you. Before we close the call, I mean, just to reiterate, we are very encouraged by the engagement in the FLEX-HCC study among the investigators and the hospitals. Usually sort of standard approach is for us to communicate via press release when we have the first patient dosed sort of in the study, and we are eagerly looking forward to that. Sort of as we have the quarterly call today and we just sort of gotten the news that sort of we now have two hospitals open to start enrolling patients, we wanted to share that today, and we are super happy that those two first are up and running, and we have drug on site.
We look forward to as Pia Baumann alluded to, also sharing the update on as that first patient is dosed and randomized. We're very happy with the progress so far. Over the past months, our belief in MIV-711 as a candidate for treatment of osteogenesis imperfecta has only grown stronger, and our development plans for MIV-711 has generated support from both clinical and regulatory experts, which has been a very nice progress. We are super pleased to see the progress with MIV-701, eagerly anticipating the results, Q4 this year. That event will be a significant potential inflection point for the program, of course.
It will be an inflection point for Vetbiolix as a company and as a result also for us here at Medivir. On that note, with the progress made and with the sort of positive outlook to the future, we thank you for attending today's call and wish you all a great day. Thank you.