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.

Thank you, Pia. I mean, the question is always sort of why do we hone in on sort of the first-line treatment, but that is when we plan for the next phase, I mean, it's important that we also plan for a phase that will survive over time, and this is why it's encouraging and important that the design of the study that we have, the Phase IIb study, with an immunotherapy, with a tetracentric Avastin in first line and then progression, that that treatment algorithm is the right one today, and that treatment algorithm will stay the same over time. encouraging from that data set to see that the centric Avastin first line will remain cemented. And 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. So again, we are focused on where the biggest unmet medical need is. There hasn't been anything new come into play. And 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. And 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, but just to 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. So 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. And that's why the combination patent and approval now in Japan is such a key. And 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. So here is the patent is for the combination with Linvima, which is then the combination we are developing and it's for use in liver cancer. So 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 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. So very happy that Japan approved and looking forward to approval from other regions as well. So 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 performance to June. And the result in cash flow, it was really in line with our forecast. Turnovers like the high-end Q2, primarily driven by royalty income from Seclear. 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 and we will have some additional wrap-up costs expected in Q3 as well. and we have made some CMC investment in a quarter for the plan phase 2b study and we estimate a lower cash outflow in the coming month and we continue to work to reduce the cost base that we have today and some final comments regarding the cash position and we have a strong support from VINC our largest shareholder and we have utilized the loan facility of 30 million SEK during the quarter And with that, we have a cash balance, end of June, amounts to 38 million. And the estimated cash runway is now end of quarter four under the current plan and the current assumptions that we have today. Then 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. And 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 belief shown by our main owner, Lincoln, 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. And we will, of course, communicate as soon as we have concluded on those discussions. So 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 Pankinus from H.C. Wainwright. Please go ahead. The next question comes from Richard Romanious from Red Eye. Please go ahead.

Hi, this is Josh on for Joe. I've had a question about Buranapant. So 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?

Well, I mean, Brinapent is an interesting molecule. It has a great safety profile. It does what it's supposed to do mechanistically in cancer cells. And we're currently evaluating several.

I think, 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 HC Wainwright regarding berinapan.

And we can just conclude that with the observation that we're currently working to find a path forward for Briennapent. And 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.

It's my turn to ask a question.

So that's where we are currently. Again, from a technical viewpoint, not sure if we are being heard or not.

Yes, you are.

Okay, good, good. So hopefully that answers the Burina Pant question. And it sounded like the next person in line was Richard from Red Eye.

Please go ahead, Richard. We seem to have a problem with Richard's line.

We did hear Richard a couple of times before.

Can you hear me?

We can hear you now, Richard.

Yes. Can you hear me?

Yes. We can hear you.

I'll just ask the question. Are your other external expenses increased a bit from Q1? What

Okay. I could hear your question, Richard. Yes. And the main reason behind that was the investment we did in CMC and that's investment for the plan phase two B. So that's the main reason for that.

You can say something about the funding and deal on biomethane oncology. It's been a bit tough. Antonia, do you see it changing going forward?

I think the obvious answer would be yes, I think that it will change. I mean, it's been a difficult sort of situation in a couple of years. I think interestingly, when we look externally, I mean, we've seen some encouraging news, arguably sort of as of late. So I think inevitably it will sort of swing back. I think from our position, sort of we are in and have been sort of in discussions with regards to finding the best way forward. So I think that I mean, we look to conclude those discussions and that's the key focus from our end and that's not dependent on sort of a shift in the environment, et cetera. We just wanna make sort of, let's conclude on those discussions and then 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.

The next question comes from Klaus Palen from DNB Carnegie. Please go ahead.

Yes, hello there. Thanks for taking my question, if you can hear me.

We can hear you.

Perfect. And 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 and just wonder if that's related to your pausing some initiatives in your preparations for the Phase 2b 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. And we have some clinicals during the first half of this year, and we will have some wrap-up costs during Q3 this year. But the preparation are going according to the plan, for the plan phase to be. Okay.

So if you would be able to secure funding in the coming months, would it be possible to initiate the Phase 2b study before year end or when do you think it would be possible?

So I can respond to that. So all the preparations, as Magnus has already said, is ongoing. And when we sort of have all the financials in place, we are ready to just press the button and start a study.

It's always difficult to give a thing. But people are eager. We're being pushed out of Congress. Let's start as soon as you can. I think that's the short answer.

Yeah, and as I think I provided a little bit earlier that this is such a high unmet need and there are no current studies ongoing, more or less. So, yeah, it's really anticipated that we start this study as quick as possible, as soon as we have.

I'm just looking to understand if you start losing some time now as we await more proper financing.

The sooner we secure the financing, the better, from a timing perspective. And this is one of the reasons why we 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? And that we're not seeing. Clearly, that doesn't mean we want to delay things, but that part is good to see. But of course, let's secure the financing and to be able to start as soon as we possibly can.

Perfect. Sounds very good, and good luck with that. 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, so I hand the conference back to the speakers for any closing comments.

Thank you, and then I mean just to sort of kind of go back to our overview slide which we've talked about a few elements today and we continue to be at the forefront, so that we're the first and only liver targeted agent we've shown quite. uh sort of with the data we showed in q1 uh sort of encouraging data set with 10.9 months time to progression pia showed today again additional studies confirming that that is significantly different or it's clearly sort of longer than what we've seen in in other studies in second line and there's nothing improved so the window towards coming the first approved treatment option in second line is there and the market is significant and the market is likely undervalued or underestimated in light of sort of the sort of fatty liver disease explosion that we're seeing. clearly again just to come back to it just to sort of make make that point uh our number one focus apart from making sure that we progress out of all the preparations for the study as evidenced by cmc investments we're doing to to make sure that we are prepared our number one focus is is to conclude on the the financial solution to find sort of the best best way forward and to conclude the the active discussions that are ongoing and as soon as we have clarity and soon as we have landed on that best way forward then we will communicate as as as soon as we can so with that uh thank you everyone for dialing in and have a good rest of the day