BioInvent International AB (publ)

Welcome to the BioInvent Q3 Report 2025 presentation. 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 the speakers, CEO Martin Welshoff and CFO Stephan Erickson. Please go ahead.

Yes, welcome everybody to our Q3 Report presentation. And as usual, Stefan and myself will go through what has happened during that time period. Stefan will cover the financials. I will do the rest. And without any further ado, I will start the presentation. Our forward-looking statement. And I would like to start with a quick summary. What has happened, events in the third quarter, as well as the events after the end of the period. And obviously one very important event during the third quarter was our prioritization in the portfolio to really focus on the two lead programs, all the resources doubling down on the two most advanced programs, 1808 and 1206. And I will come back to more details later. And then the other thing was that there was a change in the board. So Vincent Ossipo, who is with us for many, many, many years, stepped down for, you know, priority reasons. And I think this is a very normal change. And as I said, it has been with us almost 10 years. So then the events after the end of the period. So the most important thing, and we probably will discuss it also later a little bit more in detail. We are 12 for 6. We started the phase 2A trial. in advanced or metastatic non-small cell lung cancer and the real melanoma. And this is a first line study. So super exciting. So this is basically based on the good data that we have generated in heavily pre-treated patients. We showed that data to Merck and they agreed that we could go in the combo trial in first line non-small cell lung cancer and the real melanoma. So very, very exciting. Then we had some data presentations, so the phase 1 clinical data for BI1910, our TNF receptor 2 agonist for the treatment of solid tumors will be presented at CITSE in 2025. And then together with Transgene, we presented translational data and updated clinical results on the Armed Oncologic Virus Program, BT001, that was at ESMO this year. So coming back to our prioritization, so what you see here on this slide is the portfolio, and that's still our portfolio. So the thing what we're doing is, of course, now we prioritize the two lead programs, and that makes a lot of sense because those 1808 and 1206 are now in advanced clinical studies, which means phase two. Those are two assets that are active in liquid as well as in solid tumors, first in class, and the other programs on 1910, our second TNF-702 program, as well as 1607, our second anti-epithelial gamma-3 program, They are now paused, and then the BT001 program in solid tumors, which is basically the oncoleukin virus containing our anti-CTLA-4 antibody, is continued based on investigator-initiated trials. So we're really now focusing and doubling down on 1808 and 1206. And on this slide, you have a summary of what I probably already have said. So in August 2025, we announced the decision that we will focus on our two most advanced programs, BI 1206 and BI 1808. And what I always say, this is obviously an unfair competition because 1910, 1607 might be also interesting, but they're much, much more early. They're still in phase one dose escalation. And, of course, level 6 and 1808 are already in phase two. So the earlier clinical programs, as I already have said, will be paused after a one-time period to complete the ongoing trial activities because we want to pause it in a way that we can reuse it. either ourselves or with a partner. And also the underlying research activities are now streamlined to better support the two lead clinical programs, 1206 and 1808. So this slide then would show you the prioritized portfolio where we then have basically 1808 and 1206, as I've already said. So 1808 is our anti-TNFZ2 program, which is running as a single agent, as well as a combination with pembrolizumab in solid tumors and T-cell lymphomas. And Biotryphos 1206, our lead anti-FCGAMMA2B program, is running in combination for nautical lymphoma with rituximab and acalabutinib, and in solid tumors with pembrolizumab. And they are already mentioned that this trial has been kicked off where we're focusing on first-line non-small cell lung cancer and oveal melanoma. Then BT001, as I already said, continuous development in an investigator-led Phase I-II trial in collaboration with Transgene. Just for completeness, on the right-hand side of this slide, you see our partners. So whenever we use PEMBRO, we do this under a supply and collaboration agreement with Merck. And whenever we use Akala-Butnip, this is under a similar agreement with AstraZeneca. And that, of course, is something very interesting because those are two potential partners that are already sitting at the table in a way. And then, of course, the last name, this is our longstanding partner in China, CASI. They have exclusive rights for Turbo 6 in China, Hong Kong, Macau, and Taiwan. So a little bit more than in detail around the programs, just to recap where we stand. So as I already mentioned, 1808 is developed in T-cell lymphoma as well as in solid tumors as a single agent as well as in combination. Here on this slide, this is the data that we presented in June this year. Basically, the immunotherapy showing really promising strong efficacy in CTCL and PTCL. We had 100% disease control in nine available patients, complete responses, partial responses, and stable disease. And, of course, it's important to remember or to remind everybody that these patients are heavily, heavily pretreated. But we also had then, on top of that, two available patients in PDCL, which is an even more severe form of T-cell lymphoma, where we had one partial response in one patient with stable disease. Important to note that the treatment is well-tolerated with very mild to moderate adverse events, so basically no toxicity issues, and also, very importantly, immune activation. was observed early on with depletion of regulatory T cells and the influx of CD8-positive T cells into the skin lesions, which is very, very important. And then to remind everybody, so we have orphan drug designation for TCL and fast drug designation for CTCL. So what is next? This will be actually additional data already this year, additional Phase IIa data. I think we guided the market that this will come next year, but we have good progress and we will have already an update this year. Then going into the other parts of the 1808 program, which is the solid tumor study, we have established single agent activity, which is really something exciting because antibodies against TIGID or LAC3 never had done that. So we saw complete responses, partial responses, and we had actually 11 out of 26 available patients that showed a response. And obviously, again, here very, very heavily pre-treated patients. And again, I emphasize this is a single agent activity. Very good safety profile. And that was presented at ASCO, and what we also presented at ASCO in June 2024 is some first activity or data that we had in the combination, which, of course, was a little bit later since we started the single-agent clinical development first and then followed on with the combination with PEMBRO. And here we already guide the markets of the phase 2a pembrolizumab combination data in solid tumors. There will be also a first data point or the second data point actually after then the ASCO in 2024 this year. So basically for 1808 there will be an update on monotherapy for CTCL and as promised already the update on the combination with pembrolizumab in solid tumors both this year. Then I switch to our anti-ephsigamma-2b program, BI-1206, that we develop in non-optional lymphoma and in solid tumors. And start with the data that we presented also this year. That is the combination with acaloputamide and rituximab. We had 100% disease control in the first eight patients out of 30 patients in the complete trial. And, you know, complete responses, fast responses, and stable disease, a good overall response rate. And, again, also this treatment has been well-tolerated with no safety and tolerability concerns. And, of course, it's important to note that Turbo 6 is subcutaneous, so that means we have a very convenient and safe profile of this combination, which is a highly competitive option in the evolving non-optical lymphoma treatment landscape. We have also drug designation. And also here we have an update because we guided the market that will, you know, come out with a next data set during the first half of next year. And that will already happen this year. So also very, very exciting, which means that is already the third update that will come to in addition to what we already had guided the market for. So then on the other side, the solid cancer study, you might remember the data that we have shown, so very strong also data targeting patients that do not respond anymore to NTPD-1 or NTPD-L1 that were patients that have received two or more, two and three, so two or more IO treatments. We saw complete responses and partial responses. We showed that data to Merck and they agreed that we can move into first line. And that's what we have started already. So there was a press release a week or two weeks ago. And we're focusing on advanced metastatic non-small cell lancans and real metanoma. And we're focusing on sites in Georgia, Germany, Poland, Romania, Spain, Sweden, and the U.S. And here, as we have guided already the market, so we will have a first glimpse of the data during the second half of next year. Then very briefly on CTLA-4, even though that is not our core, but at least since it happened, so that was presented at ESMO. We could show that the BTC-A1 injection combination with pembrolizumab was well-tolerated, shock-positive, local, abscopal and sustained anti-tumor activity in injected and non-injected lesions, long-lasting partial responses were observed, and the overall data support for the development across a range of solid tumor types to improve responses to cancer immunotherapies. And the next step here is that the evaluation of BTC-1 will continue via the investigator-led trial in early-stage setting, what I already have mentioned. And then I hand over to Stefan for the financial overview.

Thanks, Martin. Okay, I will present the financial overview for Q3 in the nine-month period, January to September. All amounts are in SEC million, unless that was mentioned. Net sales were 3.3 million in Q3 2025. compared to 12.8 million in Q3 2024. That decrease is related to that production of antibodies for customers was 9 million lower in 2025. Net sales from January to September 2025 were 223 million. For the same period in 2024, net sales were 23 million. That's an increase of 200 million. The increase is mainly related to the $20 million payment when Soma Royalty acquired Future Royalty rights to Messa Gittermal. Prior to that, a $1 million milestone was received in the collaboration with Soma. Operating costs increased from 120 million in Q3 2024 to 137 million in Q3 2025. That's an increase of 17 million. We had quite higher cost in BI 8 and 8 and higher cost in BI 12 and 6 and somewhat lower cost in BI 19 and 10. And we also had higher personnel cost in Q3 2025. From January to September, the increase of operating costs was 77 million from 369 million in 2024 to 446 in 2025. During the period, we had quite higher costs in BI-126 and BI-808 and higher costs in BI-1910. And personnel costs in 2025 were quite higher compared to 2024. And the result for Q3 2025 was minus $129.2 million, and the result for January to September was minus $207.1. Liquid funds and current investments end of September 2025 amounted to a total 690 million. And based on our current plans, we are financed into Q1 2027. Over to you, Martin.