BioInvent International AB (publ)

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 events 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 a little bit more details later. And then the other thing was that there was a change in the Board.

So Vincent Ossipow, who is with us for many, many, many years, stepped down for priority reasons. And I think this is a very normal change.

And as I said, he 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, BI-1206, we started the Phase IIa trial in advanced or metastatic non-small cell lung cancer and uveal 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 pretreated 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 uveal melanoma.

So very, very exciting. Then we had some data presentations, so the Phase I clinical data for BI-1910, our TNF receptor 2 agonist for the treatment of solid tumors, will be presented at SITC in 2025.

And then together with Transgene, we presented translational data and updated clinical results on the armed oncolytic virus program, BT-001 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 we think what we're doing is, of course, now we prioritize the two lead programs, and that was -- makes a lot of sense because those 1808 and 1206 are now in advanced clinical studies, which means Phase II.

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 receptor 2 program as well as 1607, our second anti-Fcgamma 2b program. They are now paused and then the BT-001 program in solid tumors, which is basically the oncolytic virus containing our anti-CTLA-4 antibody, is continued based on investigator-initiated trials.

So we are really now focusing and doubling down on 1808 and 1206. And on this slide, you have a summary of what I partly 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 I, dose escalation. And of course, 1206 and 1808 are already in Phase II.

So the earlier clinical programs, as I already have said, will be paused after a [ wind-down ] 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 2 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 already said. So 1808 is our anti-TNF receptor 2 program, which is running as a single agent as well as in combination with pembrolizumab in solid tumors and T-cell lymphomas.

And BI-1206, our lead anti-Fcgamma IIB program is running in combination for non-Hodgkin lymphoma with rituximab and acalabrutinib and in solid tumors with pembrolizumab. And there, I already mentioned that this trial has been kicked off where we're focusing on first-line non-small cell lung cancer and uveal melanoma.

Then BT-001, as I already said, continues 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 acalabrutinib, 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 long-standing partner in China, CASI.

They have exclusive rights for 1206 in China, Hong Kong, Macau and Taiwan. So a little bit more then 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 monotherapy showing really promising strong efficacy in CTCL and PTCL. We had 100% disease control in nine evaluable 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 have then on top of that, two available patients in PTCL, which is an even more severe form of T-cell lymphoma, where we have 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 T cell and Fast Track 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 TIGIT or LAG-3 never have done this. 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 pretreated patients. And again, I emphasize this is single-agent activity.

Very good safety profile. And then what we also -- 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 start with -- started the single-agent clinical development first and then followed on with the combination with pembro.

And here, we already guide the market. So the Phase IIa 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-Fcgamma IIB program, BI-1206 that we develop in non-Hodgkin's lymphoma and in solid tumors.

And start with the data that we presented also this year. That is the combination with acalabrutinib and rituximab.

We had 100% disease control in the first 8 patients out of 30 patients in the complete trial and complete responses, partial 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 1206 is subcutaneous. So that means we have a very convenient and safe profile of this combination and which is a highly competitive option in the evolving non-Hodgkin lymphoma treatment landscape.

We have Orphan Drug Designation and also here, we have an update, because we guided the market that will 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 anti-PD-1 or anti-PD-L1 and 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 lung cancer and uveal melanoma, and we are 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 BT-001 inject in combination with pembrolizumab was well tolerated, showed positive local abscopal and sustained antitumor activity in injected and non-injected lesions, long-lasting partial responses were observed and the overall data support further developments across a range of solid tumor types to improve responses to cancer immunotherapies.

And the next step here is that the evaluation of BT-001 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 and the 9-month period, January to September. All amounts are in SEK million, unless otherwise mentioned.

Net sales were SEK 3.3 million in Q3 2025 compared to SEK 12.8 million in Q3 2024. That decrease is related to the production of antibodies for customers was SEK 9 million lower in 2025.

Net sales for January to September 2025 were SEK 223 million. For the same period in 2024, net sales were SEK 23 million.

That's an increase of SEK 200 million. The increase is mainly related to the $20 million payment when XOMA Royalty acquired future royalty rights to mezagitamab.

Prior to that, a $1 million milestone was received in the collaboration with XOMA. Operating costs increased from SEK 120 million in Q3 2024 to SEK 137 million in Q3 2025.

That's an increase of SEK 17 million. We had quite higher costs in BI-1808 and higher cost in BI-1206 and somewhat lower cost in BI-1910.

And we also had higher personnel costs in Q3 2025. For January to September, the increase of operating costs was SEK 77 million from SEK 369 million in 2024 to SEK 446 million in 2025.

During the period, we had quite higher cost in BI-1206 and BI-1808 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 SEK 129.2 million, and the result for January to September was minus SEK 207.1 million.

Liquid funds and current investments end of September 2025 amounted to a total SEK 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 1808 in solid tumors, a data update in combination with pembrolizumab. But in addition to that milestone, we also will update on 1808 additional Phase IIa single-agent data this year as well as additional Phase IIa data with rituximab and acalabrutinib for 1206 in non-Hodgkin's lymphoma.

Otherwise, then for next year, so we'll have then the Phase III data with pembro in [ TC/TCL ] for 1808. And then there will be then, of course, additional triplet data, so for BI-1206 in non-Hodgkin lymphoma in combination with rituximab and acalabrutinib.

And then in the second half, we'll have the first data update regarding 1206 first line in solid tumors, and that will be the first readout that will be during the second half of next year. So I stop here and open up for 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 said disclosed data on the first 8 out of 30 patients total.

Does that mean that we will get an update on the total patient on 30 with the next one? And how long will the follow-up be for that particular readout?

Yes. So for that -- Sebastiaan, for that program, BI-1206, that's in combination with acalabrutinib 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 provide a little bit more color on the 1808 readout in CTCL for the combination of pembrolizumab in tumors, like how many more patients will we get? Is it going to be like a handful?

Or is it going to be a substantial update?

For the -- so 1808, I'm just repeating because you were interrupted actually because there's some background noise where ever you are, Sebastiaan. 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.

I just continue where Sebastiaan left off. And could you remind us about the next steps for both BI-1808 in T-cell lymphoma and BI-1206 in normal lymphoma in 2026?

Yes. So basically, I start with 1808 first, as I said to Sebastiaan.

So the single-agent part, the dose escalation, et cetera, has been done, so that is finished. What we have already have started is also the combination with pembrolizumab.

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 1206, 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 a pivotal 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 and hopefully, with a very strong overall response rate plus a very high rate of complete responses, and we are quite optimistic that we can achieve that.

And 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-small cell lung cancer and uveal melanoma will be one year later.

So what -- hypothetical question, what if AstraZeneca is very interested, what are the options for MSC Merck then?

Yes. It's a very interesting question.

Obviously, first of all, maybe a slight correction. So the first data that we'll have for the 1206 pembro combination 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 1206 pembro combination as much as we can, such that we might have already some interesting data that we may be -- 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 1206, obviously subcu. And if you only would see, let's say, a 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 subcu.

So you could then really think of co-formulating KEYTRUDA subcu and 1206 subcu 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 come forward and is interested in a collaboration.

And what about an interest from AstraZeneca in combining BI-1206 with Imfinzi or durvalumab, their checkpoint in...

Absolutely. That could be another option.

So because the thing is because I get this question a lot that some people think, okay, AstraZeneca might, if they're interested to collaborate on non-Hodgkin lymphoma and Merck 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 1206 is interesting enough for them to consider collaboration to also consider on other applications besides non-Hodgkin lymphoma, absolutely.

Okay. Then I just have one more financial question.

Are we going to see any more results of the cost-cutting measures just recently? And what type of burn rate could we expect going forward?

I think you could say -- you see right now, we had -- for the first three quarters, we have SEK 446 million. So you could extrapolate that to the full year, a little bit less than SEK 600 million, and that will go down a little bit next year.

My first one would be on the readout 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 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. Got it.

And then a second question on the 1206 triplet combo data. What is the next data patients that are treated with higher dose of 1206 compared to last update?

I'm thinking the 225 milligram compared to 150 milligram that was mainly used in the preliminary data.

Yes. So basically, the data that you will see is a continuation of the data that we already presented earlier this year.

So it will be the same dose, just a higher number of patients.

Just one follow-up on the previous one. So in May of this year, you showed that all 8 patients in the triplet combo in NHL had shown a reduction of some of the target lesions, even the stable disease ones moving towards response.

And now I'm 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 or -- is there a possibility to go into Phase III as a single agent for 1808 in CTCL number?

Yes. So starting with 1206 first.

So the full 30 patients will be then at some time point next year. So I think roughly by mid 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 regulator is single-agent pivotal study. And I don't have the slide here in the deck, and I just have to memorize what we will do.

So as I said already earlier, so we're currently running the combination with pembro. In parallel, we will start with dose optimization such and then also preparing for the pivotal study such that -- and those plans are still the same.

We potentially could start a pivotal study for monotherapy first line in 2027.

So good to see the planned readout being ahead of schedule. So first off, on 1206 and the triplet, you've seen pretty upbeat, Martin, on response rates being able to move up as patient numbers increase.

So can you say anything about your expectations for the readout before year-end? 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 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.

Yes. 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 above 75%. And then on -- then the other point, obviously, is a very high ratio of complete responses.

So that is what we hope to present to the market. And then just remind me of the second part of your question.

Yes. So that was on the median duration of response for the doublet and whether or not that data is mature enough to present.

Yes. So what we have, we can present.

But obviously, so the study did not start that long ago. But 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 3 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 we can see that the responses that we get are enduring basically, right?

But it's still early days.

Yes. Thank you, everybody, for participating and also for the good questions.

So we are, of course, happy and excited that we can update the market earlier than what we projected around 1808 single-agent CTCL and 1206 in non-Hodgkin lymphoma. I think this is very good and shows the interest in the study regarding the sites that are involved.

And of course, this is driven by good data. Obviously, otherwise, 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.