BioInvent International AB (publ)

Thank you, and welcome, everybody, to our year-end report. Today is February 26, 2026. And as usual, I will start with the summary. So we had a couple of key events in the fourth quarter. First of all, the two ASH data sets. So with BI-1808, our lead candidate targeting TNF receptor 2, we saw very strong data in the T cell lymphoma. And we presented that at ASH 2025, and I'll come back to the data a little bit more in detail later. And then we had another ASH presentation about BI1206, which is our lead targeting FZGAMR2B in combination with rituximab and calquence in non-Hodgkin's lymphoma. And that was also presented at ASH 2025 and also very, very strong data set. I should mention that BI-1808, that was monotherapy, single agent therapy. Then we also started our phase 2A trial evaluating BR1206 in combination with Pembrolizumab in treatment naive advanced or metastatic non-small cell lung cancer and uveal melanoma. So this is really the first line setting. And this is, as I will explain later, based on data that we have seen in end-of-the-line patients and the data actually convinced Merck to go together with us into first line under a supply and collaboration agreement. And then last but not least, we also got orphan drug designation from EMA for BR1808, another very important milestone for the treatment of cutaneous T-cell lymphoma, CTCL. And then we had a couple of events after the end of the period. Number one, obviously, a very promising data set in our ongoing phase 2A study for BR1808 with Keytruda for the treatment of recurrent ovarian cancer. And we published that ahead of JP Morgan. And I will also discuss that data set a little bit more in detail. And then we had here in the report, and maybe not everybody is aware about this, but I will highlight it, updated clinical data sets for 1808 and PEMBRO in combination in ovarian cancer, as well as the BI-1206 study for the treatment of a neurological lymphoma. So we have additional patients there and I will mention it again when we discuss specifically those two data sets. And then also very happy that we could nominate two new board members. Of course, they still need to be confirmed and elected on the annual general meeting. Number one, Kate Hermans, a very experienced and seasoned business person in the pharma and biotech industry. And then Scott Zinnobar, who was for roughly 20 years the portfolio manager at Viking. So both two very, very strong US profiles and we're very happy to welcome them to our board. Then before I go into a little bit more in detail, just to have a quick look at our clinical pipeline. As usual, I always emphasize here, so we have multiple value drivers. So as you know, in August we focused on the two more mature programs, 1808 and 1206. And 1808 is currently running in combination with Pembrolizumab in recurrent ovarian cancer. And there we have this very nice data set that is actually continuing to generate good data. And then we have planned, so this has not been started yet, a combination with 1808, Pembrolizumab, and Paclitaxel. based on the very interesting data that Merck published at ESMO. And this is actually quite exciting because it could lead to a very interesting development in recurring ovarian cancer. Then obviously, as you already know, CTCL single agent, go briefly over the data that we presented at ASHE. And then we are currently running this also in combination with Pembrolizumab, although we already have very strong single agent data in CTCL of 1808. We still want to see how it looks in combination with Pembro. And then 1206, you know, the triplet. targeting non-Hodgkin lymphoma, specifically follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma. And there we also have an update. So the data set is maturing further and basically confirming the trend as we see also the 18-way data set in ovarian cancer in combination with pembrolizumab. So that is really very, very encouraging. And then as already mentioned on the previous slide, so we kicked off first line combination in combination with Pembrolizumab Turbo 6 in non-small cell lung cancer and uveal melanoma. And there we will see the first readout already during the second half of this year. But I will come back to the milestones this year and also an outlook into 2027 later at the end of the presentation. Here, I just want to mention that we see basically complete and partial responses in all clinical programs, which is really, really confirming the two single agent having activity in liquid as well as in solid cancer, which I think is very giving a lot of comfort. And that's what you want to see at this stage. Then going a little bit more into detail, so first our anti-T9 receptor 2 program, 808 in solid tumors, and then the same in T cell lymphoma. So we have, as already mentioned, very promising efficacy in ovarian cancer, and that is kind of building on the single agent activity that we have seen in ovarian cancer. But obviously, if you want to treat something like recurring ovarian cancer, you have to go into combination. And since we knew preclinically already that we have strong single agent activity, but also very good synergy with pembrolizumab, it was a no brainer. And that's why we did this. And in addition to the data that we have shown ahead of JP Morgan, we have one additional partial response. So one stable disease has turned now into a partial response and one additional stable disease that corresponds to 24% ORR and disease control rate of 57%. So basically the data set that we have shown ahead of JP Morgan is kind of confirmed and is maturing further into the right direction. So again, 24% overall response, 57% disease control and 21 available ovarian cancer patients, which I think is very encouraging and is showing the right trend. And also when we look on the next slide, At the spider plot, you can also see how immunotherapy is working. And we have the firm belief that 1808 could be potentially the next Gertrude. And you see here two dotted lines. So a pink one, which is basically if you're above this, it's progressive disease. If you're below this, it's stable disease. And then you have a yellow line, PR, which is basically if you then go beyond this or below this, then you have partial response. And you can see how immunotherapy is working. So you have patients at stable disease and then they're there for a while. The immune system works and then it gets pushed down into partial response. And this is actually very, very interesting because also when you look at Catruda alone is around 80% ORR in combination with our drug, it's 24%. I think this is actually a very interesting and strong data set, and of course, further maturing. Then switching to CTCL and PTCL, our T cell lymphoma data that we presented at ASH 2025, and there we have shown 46% ORR, 92% disease control in 13 evaluable CTCL patients. a very strong data set. And I should mention here also at this place, both data sets, so the one in ovarian cancer, as well as the one in T-cell lymphoma, has also a very excellent safety profile. So it's very, very well tolerated, which is important, especially when you think about the combination in ovarian cancer with pamprolizumab, because you are only able to do this in case you have a good safety profile, which we have. But going back to T cell lymphoma here on this slide. So what is important besides the good safety profile is that we see immune activation early on with depletion of regulatory T cells and the influx of CD8 positive T cells into the skin. So we have a clear skin component. And very briefly on the spider plots, here you can also see nice duration already. In this case, the black line, this is basically below that is stable disease. And then you see the dotted line is below is partial response. And you can see that we already have a complete response now in cesarean syndrome, which is really continuing for more than a year. So also you can see that duration is coming into play here. as you could see also for the more early ovarian cancer data set. So it really looks very promising. Then switching to our other program, our anti-FCGAMR2B program, 1206 and Lern-Hodgkin's lymphoma, as well as in solid tumors, starting with the Lern-Hodgkin's lymphoma. So this is the combination with rituximab and Acarabutinib, so it's a triplet. And this is a little bit different slide that we have shown so far. So we'll be splitting up now into follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. We see good responses in both. Dark green is complete. Light green is partial. And we have actually, compared to the data set that we have shown at the end of last year, four additional partial responses and one additional stable disease. keeping basically the very good 80% ORR and the disease control rate of 100%, which is, I think, excellent. And you can see activity in all three subsets. We are focusing more on follicular lymphoma because this is also more interesting for our supply and collaboration partner, AstraZeneca, because they don't have follicular lymphoma on the label of Acalabutnib. Then again, a spider plot here as well. You know, everything that is below the dotted line is good because that means it's either partial response or complete response. And then you see also quite a number of stable diseases. And you see here also that, you know, the data matures. That means you see first a stable disease and it goes into partial response and then eventually into complete response. And we also have here very, very good duration. And we have some idea about the duration from our doublet study that we did before. That was just 12 or six in combination with rituximab. And of course, the patient population that we're focusing on is our patients that do not respond anymore to any CT20-based therapy. And there we have now a couple of patients that actually are in complete response for several years after the end of the study. So then on the solid cancer side for 1206, this is a data set that is from the dose escalation where we were targeting patients and of the line patients that do not respond anymore to either NTPD1 or NTPDL1. where we also had some very interesting signals. So we had very interesting complete and partial responses. And based on that, we went back to Merck and our partner here for the supply and collaboration on a combination with Getruda. And we agreed that we should go into a phase IIa first line non-small cell lung cancer and VL melanoma. with 1206 and Pembrolizumab. This is now ongoing. And as I said, so the first readout will be and during the second half of this year, which is pretty soon anyway. Then I will hand over to Stefan.

Thank you, Martin. I will present the financial overview for Q4 and the 12-month period January to December. All amounts are in SEC million unless otherwise mentioned. Net sales were 3 million in Q4 2025 compared to 21.4 million in Q4 2024. That's 18 million lower in Q4 2025. That decrease is related to that production of antibodies for customers was lower in 2025. And net sales for January to December 2025 were 226 million for the same period in 2024. Net sales were 45 million. That's an increase of 182 million. The increase is mainly related to the $20 million payment we received when Soma Royalty acquired Future Royalty and Milestone's interest for Mesagitama. And before that, we got a $1 million milestone in that collaboration. Production of antibodies for customers was 19 million lower in 2025. Operating cost decreased from 147 million in Q4 2024 to 132 million in Q4 2025. That's a decrease of 15 million. We had quite higher cost in BI-808 and quite lower cost in BI-607 and lower cost in BI-206 and BI-1910. And we had somewhat higher personnel cost in Q4 2025. From January to December, the increase of operating costs was 62 million from 516 million in 2024 to 578 million in 2025. We had quite higher cost in BI 8 and 8 and BI 12 and 6 and quite lower cost in BI 6 and 7. A lower cost for production of antibodies for customers. And personnel cost in 2025 were quite higher compared to 2024. And the result for Q4 2025 was minus 125.8 million. And the result for January to December 2025 was 332.9 million. And liquid funds and current investments end of December 2025 amounted to in total 593 million. And finally, and based on ongoing studies, BuyInvent is assessed to be financed for the coming 12-month period. Over to you, Martin.

Thank you, Stefan. So at the end of the presentation, I want to go over the key catalysts for the remaining part of this year, as well as give you an outlook for 2027. And as you will see, this is actually a quite dense picture here. So we have a lot of interesting news this and next year. So starting with 1808 and T-cell lymphoma, so already by mid this year, we'll have first phase 2A data in combination with PEMBRO, but also additional monotherapy data since we do dose optimization at the moment. Then for 1808 in solid tumors, second half of this year, we should have further phase IIa data in combination with PEMBRO. And as you could see already here, so the data's maturing to the right direction. So that should be also a very interesting milestone to looking forward to. Then switching to 1206 or Epsigam R2b platform, we'll have mid-year already the additional phase IIa data in combination with rituximab and acalabutinib. And then last but not least, TURBO6 in solid tumors, first-line non-small cell lung cancer and mobile melanoma. We'll have the first readout of that data during the second half of this year. Then looking into 2027, again, starting from the top, first our TNF receptor 2 platform, 1808 in T cell lymphoma. During the first half, we'll complete the phase 2A dose optimization. That is the monotherapy. And then during the second half, we could potentially start the pivotal study. Then 1808 and solid tumors during the second half of next year would have potentially the first phase IIa data, the triplet in combination with PEMBRO and Paclitaxel. And this is actually quite interesting because in case we really see a nice uplift there and maybe we can later discuss it during the Q&A in more detail. This could also then lead immediately, of course, data-driven to a pivotal study. So a very, very interesting program to follow. Then FcGamma2b, TURPO6 in non-Hodgkin lymphoma. So during the first half of 2027, we potentially could start the pivotal triplet study. And then in the solid cancer, first-line non-small cell lung cancer and uveal melanoma, During the first half of 2027, we complete the Phase IIa data and could potentially start during the second half Phase IIb BR1206 plus PEMBRO in non-small cell lung cancer. So as I mentioned, a very dense news flow, very interesting milestones, and that should be something really looking forward to. And I think I will end here my presentation and happy to take questions. Thank you.

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 Richard Romanious from Red Eye. Please go ahead.

Good afternoon. Why not start off on the last slide? When do you think it would make sense to take in a partner to conduct any of these studies? I guess it would be some of the studies in 2027.

Yeah, so basically what I can say to that, we are in interesting discussions, as you know. So we have a very active approach in business development partnering anyway, and we are in discussions with some company for some time. Obviously, we have AstraZeneca and Merck already at the table in a way through those supply and collaboration agreements, and they follow the programs very closely. and uh i think um we might already see some activity around uh partnering potential partnering deal making um during the second half of this year um of course you can never promise it's always then dependent on the data on on you know what the uh market environment is etc etc but uh we will be keen to partner one or the other um with uh you know hopefully large pharma companies such as Merck and AstraZeneca.

Right. Could you just clarify more in detail exactly what more do you need to accomplish with BI 1206 in NHL to make the triplet ready for a pivotal trial?

Yeah, so basically we will have, as I already mentioned, the 30 patients in the current ongoing study. That's enough. And then we can discuss with the regulators and start preparing for a potential pivotal study. That's why I think that will take the rest of the year once we have the data by mid this year and then could could start that potentially next year. But also to mention it here is our main focus currently from a strategic perspective is more on the solid cancer side because that is a much stronger value driver. But we are committed to get the TCL as well as the NHL that you are talking about ready for potential people to study.

Last question. What funding options do you have for 2027?

Yeah, so obviously we look at everything all the time. Number one, we're looking at partnering. And number two, of course, there's always a financing option because I think if you have good data as we have, you have always both possibilities, but we have a strong focus on partnering.

All right, thanks for taking my questions.

Thank you, Richard.

The next question comes from Sebastian van der Schoot from Kempen. Please go ahead.

Hello, thanks for taking my question. I'm Chiara Montironi on behalf of Sebastian. So, a couple from me, if I may, again, regarding potential partner discussion. Could you go over whether BI-1206 or BI-1808 is one of the more logical options to out-license? And the second question will be around UVL melanoma and first-line non-small cell lung cancer dataset. for BI 1206. Can you provide some insight into what magnitude of efficacy would give you enough comfort to continue forward with the program? Thank you.

Yeah, thank you very much for those questions and very nice to meet you. So regarding partnering, we are currently discussing both 1808 and 1206. So we have discussions around both programs and that's also what you should do. as a biotech company because you can't be picky. You have to see what opportunity turns up and then you go from there. My dream scenario would be though that we keep 1808 a little bit longer and partner 1206 first. But as I said, so we have discussions around both at the moment. Then regarding the data set of 1206 in first line non-small cell lung cancer, I think what we would like to see as a target is 60% ORR, and I think then we will be in good shape.

Okay, thank you.

The next question comes from Arvid Niekatter from DNB Carnegie. Please go ahead.

Good afternoon, and thanks for taking my questions. I came a bit later, so I'm sorry if the questions have already been answered. But the first one on 1206, so really good to see the breakdown of responses by subtype in NHL. So on the back of this analysis, I just wanted to ask if follicular lymphoma is the indication that makes most sense to pursue in a registration-directed trial. And then I guess secondly, on the non-small cell lung cancer data targeted for second half of the year, which will provide an important new signal, how should we think about expectations here? What would mark a strong outcome in your view? Yeah. Thanks.

Thank you for your questions. Maybe I start with the last one first, because there was a little bit of an overlap regarding that already. So what we hope to see, our expectation is that we see an ORR, so that's about BR1246 in combination with pembrolizumab in first nine non-small cell lung cancer of 60%. I think if you see that, that will be a strong signal. And in that sense also, it's a very good clinical trial because we really put it to the test. And if you see this kind of response, I think we are very happy. And I think that would be also something that is super interesting for Merck or should be super interesting for Merck. Then regarding 1206 and non-Hodgkin lymphoma, yes, I think the activity is in all three and we had a... a stronger focus on follicular lymphoma. And I think I mentioned it during the presentation, maybe you didn't hear this. This is a little bit driven by our supply and collaboration partner, AstraZeneca, because Acalabutinib doesn't have follicular lymphoma on the label. And since we think that might be a potential partnering possibility, we were focusing on follicular lymphoma a little bit more than on the other two. And what we were trying to do is have a focus on follicular lymphoma at the same time point, also showing that it works for marginal zone as well as mantle cell lymphoma, which I think we clearly did. And of course, also for the audience here, when you look at neurological lymphoma, the largest, by far largest population is follicular lymphoma. I think also from a commercial perspective, it makes a lot of sense.

Perfect. Thank you, Martin. I'll jump back in the queue.

Thank you.

The next question comes from Dan Akshuti from Pareto Securities. Please go ahead.

Hi, Martin, and congrats on the progress now with potentially two pivotal programs next year. And I think there's been now lots of discussion about partnering and, yeah, both drugs work in multiple settings. uh i'm thinking a bit like how are you going into these negotiations if you can share a bit more because follicular lymphoma for instance as with any any approved immune oncology drug they never stay approved in only one indication so it's kind of a mechanism proof of concept that you have are you marketing this specifically or do you see interest from that from the pharma side to to basically not just do a deal on the indication, but more broader on the drug or on the mechanism, and then how you approach that for both drugs, the 1808 and 1206. And if you have gotten this kind of interest from pharma, or has it been very indication-specific? Thank you.

Yeah, thank you, Dan. So I think in general, you can say, and that's, you see it also here on this slide. So, you know, 1808 is our TNF receptor 2 platform and 1206 is our FC gamma 2B platform because both mechanisms, as you say, are broad. And of course, what you do in early clinical development, you try to find signal that you can follow in order to generate some more uh comprehensive data sets and that's what we're doing and especially as a small company you have to be very prudent uh because you can't go too broad at the beginning but just to go through maybe uh step by step so when you look at 1808 first maybe there you can clearly see that we already have established a very broad efficacy range, so remember probably the single agent activity in GIST, in ovarian cancer, but also in lung cancer. And now the strong data set in combination with pembrolizumab. At the same time point, we also see a strong single agent activity in T cell lymphoma. So they already can go and see the broad potential application range that you have for that compound. and talking about 1808 first, maybe. So yes, the discussions that we have, of course, initially indication driven, because wherever you have the first more comprehensive data set, that's what drives it. And of course, that we had with TCL. But now, since we have the ovarian cancer data set since early this year, we also have interesting discussions around ovarian cancer, obviously. So absolutely broad. And the same is true for 1206. So we have this in non-Hodgkin lymphoma. And of course, the study that we run is very targeted towards AstraZeneca in a way. So we'll see how that works out. And we'll know that probably already quite soon. But then you have the solid tumor side where we work in combination with pembrolizumab. And especially 1206 is quite interesting because there we have a supply and collaboration agreement with AstraZeneca regarding Acalabutinib for nonoxygen informer. And of course, then the same, not the same, but also a supply and collaboration agreement with Merck for the solid cancer side. And on the solid cancer side, for both compounds, I also would say, starting again with 1808, if we continue to see what we see, then it will not be only interesting for ovarian cancer. It will be also interesting for other cancers, like maybe triple negative breast cancer, for example, and maybe other solid cancers. very broad application potential, but we go one step at the time. So current focus clearly on ovarian cancer, which is already a quite interesting market. And the same is true for 1206 in solid tumors, if it should work as we hope. So around 60% ORR in first line non-small cell lung cancer. then there's no reason why it should not work with other solid cancer indications in combination with cannibalism up first line. So both have a platform. It's a platform potential and platform application. And that's how also our discussions are driven. So obviously they start with the first data sets. And once you have done the other data sets that continues to grow. And of course, what we are trying to do is to see that we also reach that stage. So with 1808, we have that now with the ovarian cancer data, and there will be further ovarian cancer data already during the second half of this year. And then for 1206, with the second half of this year, the first readout for the combination with PEMBO and first-line non-small cell lung cancer also will initiate this type of discussions.

Great, thank you. Just a follow-up, if I may, and maybe you cannot answer it, but do you... Do you can share if you see a willingness from pharma to value these assets broadly and like if they're interested in broader patterns beyond composition of matter or like broader preclinical data that you have? Do you see signs that are really indicating that they're interested really in the platform or maybe you cannot share that with us, but if?

Well, I can talk about it in, of course, general ways. And I can refer a little bit to the discussions that we had during JP Morgan. We had one discussion, which was really interesting, where exactly what you were describing was the case. You know, they obviously were super intrigued by the T cell lymphoma data, but then also say you have this very beautiful ovarian cancer data. Plus also, I think, interesting for the audience, we just uploaded also a publication that is really describing in detail how it works. And I think a lot of partners or potential partners really value the depth that we have regarding the science. So we can really and have described in this publication how 1808 works in detail. And I think the clinical data in hand with the preclinical data and science data and mechanistic data basically is important to drive good and fruitful partnering discussions. Maybe you have that.

Cool. Thank you very much.

Thank you, Dan.

The next question comes from Oscar Hafen Lamb from Stifel. Please go ahead.

Thank you for taking my questions. My first one will be on 1808 in CTCL. I mean, with data expected in combo with PEMBRO in mid-2026 and, you know, a potential start of a pivotal trial by next year, I was just wondering on what we'll basically decide whether to use the monotherapy or the combo with PEMBRO in the pivotal trial. I mean, will it be purely based on efficacy? Will it be safety as well? Just curious to hear your thoughts on that.

Yeah, so basically, just as a background also to the audience, so currently and coming back to the milestone that you were just referring to, so it will not be only the PEMBRO data, there will be also additional PEMBRO combination data, but also additional MONO data. So because what we're currently doing is we run it in combination with PEMBRO, but we also do already dose optimization in MONO. or with the single agent, basically. And a drive, of course, will be that you have to see a significant better ORR. And of course, at the end, also, it's a little bit early for that. But duration, of course, is also important. And then, of course, also safety. So we did some analysis with some external help. uh and the expectation would really if you combine it with spam bro that you see an uptick in in efficacy uh and of course you don't want to have uh safety problems because at the moment uh safety is really really good and i think that is also a very important aspect of our monotherapy data that we have so far, because since we have such a good safety, we could also go into earlier lines of the disease, you know, since we have no toxicity. And I think that is also quite important and of course would make also the patient population that you might put be possible to treat would widen this up basically. So we really want to see an uptick. And the reason why we do it is basically just to see whether we can have a better efficacy. I think the efficacy that we already have as a monotherapy is good, is exceptional, especially in combination with the safety that we see.

Thank you. Just to follow up on that, how many patients do you target to have in CTCR before the MS phase 2 meeting with the FDA?

Yeah, so it will be the full data set. I don't have that at the moment in front of me. I think what we have shown so far was 15 plus patients. So it will be kind of roughly the double amount. And I think for the Now we're talking about the monotherapy data, and then for the PEMBRO data, it's something around 15 patients, right, in combination with PEMBRO.

Okay. Just one last question for me. I'm still on 1808, but this time in ovarian cancer. Is the decision to add Pachytaxel to the combo of 1808 and Keytruda done in the back of some conversations with Merck? I mean, maybe they've hinted to what they want to see in the data. And then maybe as a follow-up on that, how many patients will you recruit for that arm?

Yeah, so basically that thought was triggered much, much earlier, and it was already part of our protocol when we started the doublet. We first just wanted to see how it works in combination with PEMBRO, and this we know now. So it's 18% ORR, 8% ORR compared to 24 in the combination. And since we were following the field quite closely, we had already in the protocol that we could go with a triplet. And we also have done already some preclinical work. And we know 1808 works also very well with Paclitaxel. So once we saw the ESMO data published by Merck and then the only thing that was missing, we were actually already quite convinced by that, but the only thing that we're missing then for us to really plan this more seriously was then the approval of PEMBRO and Paclitaxel. And we expect, you know, a super cool safety profile. It is no other safety issues compared to, you know, Ketruda combined with Paclitaxel. Plus, of course, a very nice uptick in overall response rate. And here again, I don't have the patient numbers in front of me, but I think it was around 30 patients that we were going to do in the triplet. maybe a little bit more, at least the amount of patients that will be needed in order to have as a next step a potential pivotal study. Thank you very much. Thank you, Oskar.

As a reminder, if you wish to ask a question, please dial pound key 5 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.

Yeah, thanks everybody for participating in our call, plus also the very good questions. I think that discussion around those questions helped a lot to really demonstrate and show that we had a very important and interesting time of the company. The slide of the key expected clinical milestones is still up on this presentation, so I think With that, you can clearly see a very dense news flow, as I already mentioned. And each of those programs can drive very interesting value development for the company. So stay tuned. And already by mid this year, there should be more. And then we will see where we land. But I'm very optimistic for the company. And I think for me, from my perspective, the most important thing is the data. the data is good and we knew that already but also it's maturing in in the right direction so i think that gives me a lot of hope and confidence thank you very much