speaker
Martin
President & Chief Executive Officer

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.

speaker
Stefan
Chief Financial Officer

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.

speaker
Martin
President & Chief Executive Officer

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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-

Investor presentation