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.

Thank you, Stefan. So then at the end, I would summarize again the key catalysts for the remaining 2025 and 2026. I think I mentioned it already, but I think it's always good to go over this again, and you see it here on this slide. Since there has been some changes, because originally we guided the market that we will have for 18-weight and solid tumors, a data update in combination with Pembrolizumab. But in addition to that, my stone, we also will update on 808 additional phase 2A single agent data this year, as well as additional phase 2A data with rituximab and acalabutinib for 12.6 and non-Hodgkin lymphoma. Otherwise, then, for next year, so we'll have, then, the Phase 2A data with PEMBRO in TCL for 1808. And then there will be, then, of course, additional triplet data, so for BR1206 and Roche-Linfoma in combination with Daxnod and Akala Putnip. And then in the second half, we'll have the first data update regarding 12.6, first line in solid tumors. And that will be the first readout. It will be during the second half of next year. So I stop here and open up for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Sebastian van der Schoot from Kempen. Please go ahead.

Hi, guys. Thank you for taking my questions. There appears to be a lot of data still coming in 2025, and I just wanted to know whether you can provide a little bit more color on the different readouts, maybe starting with the triple regimen for 1206. I noticed on the slide that it said disclosed data on the first eight out of 30 patients total. Does that mean that we will get an update on the total patient number 30 with the next one, and how long will the follow-up be for that particular readout?

Yeah, so for that, hi Sebastian, for that program, we had 12.06, that's in combination with Acalabutinib and Rituximab. So basically we have now more patients, we'll have an update on the overall response rate, we'll have an update on the complete response rate. So basically an update on the study as it's going at the moment.

Okay, got it. And could you also cite a little bit more color on the 1808 readouts in CTCL for the combination of Pembrolizumab and CTCL? Like how many more patients do we get? Is it going to be like a handful or is it going to be a substantial update?

So 1808, I'm just repeating because you were interrupted actually because there's some background noise wherever you are, Bastiaan. So for 1808, this is, of course, monotherapy in T-cell lymphomas, right? So not combination. And because the combination will be next year as already guided, so this is an additional update that we have. And as you might remember, so the single agent part or dose escalation has been done. And that will be basically then a further analysis on that data and update where we are with the different complete responses, partial responses, and stable diseases. And then also quite some interesting information on the translational side.

Okay, got it. Thank you so much, Martin.

You're welcome, Sebastian.

The next question comes from Richard Romanius from Red Eye. Please go ahead.

Hello. Good afternoon. I'll just continue where Sebastian left off. And could you remind us about the next steps for both VIH and OAT and T cell lymphoma and BI 1206 in normal lymphoma in 2026.

Yeah, so basically I start with 1808 first. As I said to Sebastian, so the single agent part, the dose relation, et cetera, so has been done, so that it's finished. What we already have started is also the combination of spambolizumab. And the reason why we do this is just to see whether it can be even better. So as you remember, so the data, the single agent data is very impressive. But nevertheless, we also wanted to test the combination. And that is currently ongoing. And the update on that data will then be at some time point next year. And then for 2006, the update that is coming now is basically a further progress of the study. And then next year, we will, of course, then finish the 30 patients, and then it depends on the data a little bit where we move, but we already had discussions with the regulators such that we potentially could do at some time point if we want to study. But as you know, so this is something that we want to do in a collaboration. So basically what we're doing is to finish really up the 30 patients that will happen during next year.

uh and hopefully with a very strong overall response rate plus a very high rate of complete responses and we're quite optimistic that we can achieve that um i was thinking about your potential license partners you're going to get some data in the triple combination now and somewhere in early 2026 while the data in combination with pembrolizumab in non-sponsored lung cancer and uveal melanoma would be one year later. So what hypothetical question, what if AstraZeneca is very interested, what are the options for MSD-MERC then?

Yeah, it's a very interesting question. Obviously, first of all, maybe a slight correction. So the first data that we'll have for the 12.06 Pembroke elimination will be during the second half of next year. So it's not a year later because I think we'll have during the first half, we'll have then further update or actually what we have guided now it's mid next year on the triplet. So I think We might even have, and as you know, Merck as well as AstraZeneca, they don't have any rights, but they see the data a little bit earlier. So what we're doing now is pushing really hard on the Turbo 6 Pembroke combination as much as we can, such that we might have already some interesting data that we maybe that are not in the market yet, but that Merck will see since they are following us closely. And that could then trigger interesting discussions. So that might be enough. Let's say AstraZeneca would make the move. And if Merck would see something that is bubbling up, something interesting that is bubbling up, they might be able to counter. And also, I think I will use the opportunity here to update or to remind everybody. So with 306, obviously, sub-Q, And if you only would see, let's say, 10% increase of responses to Keytruda first line. This is, of course, a very interesting thing for Merck because Merck Keytruda or Merck's Keytruda has been just approved as sub-Q. So you could then really think of co-formulating Keytruda sub-Q and Turbo 6 sub-Q into one injection, basically. And that could be something very, very interesting. And coming back to your question, so I think if we see initial data, and Merck would see that rather early, they might then still be able to react in case AstraZeneca should, you know, come forward and is interested in a collaboration.

And what about... an interest for Master Seneca in combining the A12 sets with Infimacy or Debalma. There is a checkpoint in that.

Yeah, absolutely. That could be another option. Because the thing is, because I get this question a lot, that some people think, okay, AstraZeneca might, if they're interested, collaborate on non-optical informer and work on solid cancers. But if either party is interested to do that, then probably they will opt for the full program, even if they have some specific interest. So AstraZeneca absolutely could also then consider, if they think Turbo 6 is interesting enough for them to consider collaboration, to also consider on other applications besides non-optical informer. Absolutely.

Okay, thanks. Then I just have one more financial question. Are we going to see any more results of the cost cutting measures introduced recently, and what type of burn rates could we expect going forward?

I think you could say, you see, right now we had, for the first three quarters, we have $446 million, so you could extrapolate that through the year. A little bit less than $600, and that will go down a little bit next year.

Okay, great. Thanks for taking my questions. Thank you, Richard.

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

Thanks for taking my questions. My first one would be on the readouts that are coming out earlier than last communicated. Could you just give us some granularity on the reasons behind? Is it simply due to a faster recruitment than you initially planned?

It's basically due to progress, you know, on different fronts. Obviously, recruitment is one part of it. But the interest in both studies is very high. So recruitment is going very well. And then, of course, you have better progress than we originally planned. So that's the main reason. That's the main reason.

Okay, great. Thanks. And then the second question on the 1206 triplet combo data. What are the next data, like the patients that are treated with higher dose of Sovo6 compared to the last updates? I'm thinking, you know, the 225 mg compared to the 150 mg that was mainly used in the preliminary data.

Yeah, so basically the data that you will see is the continuation of the data that we already presented earlier this year. So it will be the same dose, just a higher number of patients. Okay, great. Thank you. Thank you, Oskar.

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

Hi, Martin, and thank you for taking my question. Just one follow-up on the previous one. So in May of this year, you showed that all companies Eight patients in the triplet combo in NHL have shown a reduction of some of the target lesions, even the stable disease ones were moving towards response. I'm now just wondering, is this end of this year, is that going to be another interim readout, or will it be of the full 30 patients, or will we get the full one then still in the first half of next year? Yeah, thank you. Yeah, absolutely. Is there a possibility to go into phase three as a simulation for 1808 in CPCL? Thank you.

Yeah, so starting with 1206 first, so the full 30 patients will be then at some time point next year. So I think roughly by next year. So what we have now is not the full 30 patients yet, but significantly more what we have shown in May. And on 1808. So, yes, absolutely. So the plans and what we have discussed with the regulators is, you know, single agent pivotal study. And I don't have the slide here in the deck and I just have to, you know, memorize what we will do. So as I said already earlier, so we're currently running the combination with PEMBRO. In parallel, we'll start with dose optimization and then also preparing for the pivotal study such that those plans are still the same. We potentially could start a pivotal study for monotherapy first line in 2027. Okay.

Thank you very much, Markus.

Thank you, Dan.

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

Good afternoon, and thanks for taking my questions. So good to see the planned readouts being ahead of schedule. So first off, on 1206, you seem pretty upbeat working on response rates being able to move up as patient numbers increase. So can you say anything about your expectations for the readout and what would make this readout live up to expectations. And secondly, you should have a pretty substantial data set on the doublet, and we've seen some really nice long-lasting responses, and we've also seen the duration of the complete responses, but can we also expect you guys to disclose the median duration for all responses? Is this data mature enough, essentially? I'll start there, thanks.

Yeah, thank you. So for the data package, what we're expecting is basically, as I already mentioned earlier, the overall response rate. That should be, and that's our target, about 75%. And then the other point, obviously, is a very high ratio of complete responses. So that is what we hope to present to the market.

um and then uh just remind me of uh the second part of your question yeah so that was from the uh uh median duration of response for the dub lesson whether or not that data is mature enough to present

Yeah, so what we have, we can present, but obviously, so the study did not start that long ago. But, you know, it looks like what we have seen, but it's, of course, since the study is still relatively young, still preliminary data, but it looks that we have a similar or the same duration as we already have presented when we came out with the doublet data. And also to tell everybody, so those patients that were in complete response are still in complete response. So now this is more than three years for some of those patients. But obviously we don't have the same length with the triplet combination because that just started less than a year ago. But, you know, we can see that the responses that we get are enduring, basically, right? But it's still early days.

Great. Thanks, Martin. 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.

Yeah, thank you everybody for participating and also for the good questions. So we are, of course, happy and excited. that we can, you know, update the market earlier than what we projected around 1808 single-agency TCL and 1206 and mononuclein and FOMA. I think this is very good and shows the interest in the study regarding the science that are involved. And, of course, this is driven by good data. Obviously, otherwise, you know, we wouldn't have that progress. And then also next year, I think we are really then zoning into a very interesting phase of the company because then we have more mature data, which should drive partnering and or financing. And I'm really looking forward to that, especially partnering. So I think I will conclude with those words. I don't know, Stefan, do you have any final comments from your financial perspective?

No further comments.

Okay, then I think we can close the meeting. Thank you very much and talk to you soon.