Welcome to the BioInvent Q3 port 2025 presentation. During the questions and answers session, participants are able to ask questions by dialing on their telephone keypad. Now I will hand the conference over to the speakers, CEO Martin Welschof and CFO Stefan Ericsson. Please go ahead.
Yes, welcome everybody to our Q3 report presentation. 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. Without any further ado, I will start the presentation with 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. 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, BI-1808 and BI-1206. I will come back to a little bit more details later. The other thing was that there was a change in the board. Vincent Osipo, who is with us for many, many years, stepped down for priority reasons.
I think this is a very normal change. As I said, he has been with us almost 10 years. The events after the end of the period, the most important thing, and we probably will discuss it also later a little bit more in detail, BI-1206, we started the Phase II-A trial in advanced or metastatic non-small cell lung cancer and uveal melanoma. This is a first-line study, so super exciting. 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 uveal melanoma. Very, very exciting. We had some data presentations. 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.
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. Coming back to our prioritization, what you see here on this slide is the portfolio and that's still our portfolio. What we're doing is, of course, now we prioritize the two lead programs and that makes a lot of sense because those, BI-1808 and BI-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. The other programs, BI-1910, our second TNF Receptor 2 program, as well as BI-1607, our second FcγRIIB antibody program, they are now paused. The BT-001 program in solid tumors, which is basically the oncolytic virus containing our anti-CDLA4 antibody, is continued based on investigator-initiated trials.
We are really now focusing and doubling down on BI-1808 and BI-1206. On this slide you have the summary of what I partly already have said. In August 2025 we announced the decision that we will focus on our two most advanced programs, BI-1206 and BI-1808. What I always say, this is obviously an unfair competition because BI-1910, BI-1607 might be also interesting, but they're much, much more early. They're still in phase I dose escalation. BI-1206 and BI-1808 are already in phase II. 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. The underlying research activities are now streamlined to better support the two lead clinical programs, BI-1206 and BI-1808.
This slide then would show you the prioritized portfolio where we then have basically BI-1808 and BI-1206, as I already said. BI-1808 is our 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. BI-1206, our lead FcγRIIB antibody program, is running in combination for non-Hodgkin lymphoma with rituximab and acalabrutinib and in solid tumors with pembrolizumab. I already mentioned that this trial has been kicked off where we're focusing on first-line advanced/metastatic non-small cell lung cancer and ovarian melanoma. 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.
Whenever we use pembrolizumab, we do this under a supply and collaboration agreement with Merck, and whenever we use acalabrutinib, this is under a similar agreement with AstraZeneca. That is something very interesting because those are two potential partners that are already sitting at the table in a way. The last name, this is our longstanding partner in China, CASI . They have exclusive rights for BI-1206 in China, Hong Kong, Macau, and Taiwan. A little bit more then in detail around the programs, just to recap where we stand. As I already mentioned, BI-1808 is developed in T cell lymphoma as well as in solid tumors as a single agent and in combination. Here on this slide, this is the data that we presented in June this year. Basically, the monotherapy is 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. Of course, it's important to remember or to remind everybody that these patients are heavily, heavily pretreated. We also had, on top of that, two available patients in PDCL, which is a more severe form of T cell lymphoma, where we had one partial response and one patient with stable disease. It is important to note that the treatment is well tolerated with very mild to moderate adverse events, so basically no toxicity issues. Also, very importantly, immune activation was observed early on with depletion of regulatory T cells and the influx of CD8+ T cells into the skin lesions, which is very, very important. To remind everybody, we have orphan drug designation for TCL and fast track designation for CTCL. What is next?
There will be additional data already this year, additional Phase II-A 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. Going into the other part of the BI-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 that. We saw complete responses, partial responses, and we had actually 11 out of 26 available patients that showed a response. Obviously, again here, very, very heavily pretreated patients. I emphasize this single agent activity, very good safety profile.
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 pembrolizumab. Here we already guide the market. The Phase II-A pembrolizumab combination data in solid tumors, there will be also a first data point, or the second data point actually, after ASCO in 2024 this year. Basically for BI-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. I switched to our anti-FcγRIIB antibody program BI-1206 that we develop in non-Hodgkin lymphoma and in solid tumors.
I 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 eight patients out of 30 patients in the complete trial. Complete responses, partial responses, and stable disease, a good overall response rate. Again, also this treatment has been well tolerated with no safety and tolerability concerns. Of course, it's important to note that BI-1206 is subcutaneous. That means we have a very convenient and safe profile of this combination, which is a highly competitive option in the evolving non-Hodgkin lymphoma treatment landscape. We have orphan drug designation. Also here we have an update because we guided the market that we will come out with a next data set during the first half of next year, and that will already happen this year.
Also very, very exciting, which means that is already the third update that will come in addition to what we already had guided the market for. 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-PDL1 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. That's what we have started already. There was a press release a week or two weeks ago and we're focusing on advanced/metastatic non-small cell lung cancer. We're focusing on sites in Georgia, Germany, Poland, Romania, Spain, Sweden, and the U.S.
As we have guided already the market, we will have a first glimpse of the data during the second half of next year. Very briefly on CTLA-4, even though that is not our core, but at least since it happened, that was presented at ESMO, we could show that the BT-001 injection combination with pembrolizumab was well tolerated, showed positive local, abscopal, and sustained antitumoral activity in injected and non-injected lesions. Long lasting partial responses were observed, and the overall data support further development across a range of solid tumor types to improve responses to cancer immunotherapies. The next step here is the evaluation of PTZone via the investigator-led trial in early stage setting, which I already have mentioned. I hand over to Stefan for the financial overview.
Thanks Martin. Okay, I will present the financial overview for Q3 and the nine 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, which 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 cost in BI-1808 and higher cost in BI-1206 and somewhat lower cost in BI-1910, and we also had higher personnel cost 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 cost in BI-1910, and personnel costs in 2025 were quite higher compared to 2024. The result for Q3 2025 was SEK -129.2 million, and the result for January to September was SEK -207 million. Liquid funds and current investments at the end of September 2025 amounted to in total SEK 690 million, and based on our current plans, we are financed into Q1 2027. Over to you, Martin.
Thank you, Stefan. At the end, I would summarize again the key catalyst 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 the slide since there have been some changes because originally we guided the market that we'll have for BI-1808 and solid tumors a data update in combination with pembrolizumab. In addition to that milestone, we also will update on BI-1808 additional Phase II-A single agent data this year as well as additional Phase II-A data with rituximab and acalabrutinib for BI-1206 in non-Hodgkin lymphoma. Otherwise, for next year, we'll have the Phase II-A data with pembrolizumab in T cell lymphoma for BI-1808, and there will be additional triplet data for BI-1206 in non-Hodgkin lymphoma in combination with acalabrutinib.
In the second half, we'll have the first data update regarding BI-1206 first-line in solid tumors. That will be the first readout during the second half of next year. I stop here and open up for questions.
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 Sebastiaan 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 BI-1206. I noticed on the slide that said disclose 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? How long will the follow-up be for that particular readout?
Hi Sebastiaan, for that program, BI-1206, that's in combination with acalabrutinib and rituximab. We have now more patients. We'll have an update on the overall response rate and an update on the complete response rate, basically an update on the study as it's going at the moment.
Okay, got it. Could you also provide a little bit more color on the BI-1808 readouts in CTCL for the combination of pembrolizumab 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.
BI-1808. I'm just repeating because you were interrupted actually because there's some background noise wherever you are, Bastian. For BI-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. This is an additional update that we have, and as you might remember, 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. There is also quite some interesting information on the translational side.
Okay, got it. Thank you so much, Martin.
You're welcome, Sebastiaan.
The next question comes from Richard Ramanius from Redeye. Please go ahead.
Hello, good afternoon. I'll 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 non-Hodgkin lymphoma in 2026?
Yeah, so basically I start with BI-1808 first as I said to Sebastiaan. The single agent part, the dose, etc., has been done. That is finished. What we have already started is also the combination with pembrolizumab, and the reason why we do this is just to see whether it can be even better. As you remember, the data, the single agent data, is very impressive. Nevertheless, we also wanted to test the combination, and that is currently ongoing. The update on that data will then be at some time point next year. For BI-1206, the update that is coming now is basically a further progress of the study. Next year we will, of course, then finish the 30 patients, and it depends on the data a little bit where we move.
We already had discussions with the regulators such that we potentially could do at some time point a pivotal study. This is something that we want to do in a collaboration. 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. We're quite optimistic that we can achieve that.
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 melanoma will be or one year later. What hypothetical question, what if AstraZeneca is very interested? What are the options for Merck then?
Yeah, it's a very interesting question. Obviously, first of all, maybe a slight correction. The first data that we'll have for the BI-1206 pembrolizumab combination will be during the second half of next year. 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. 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. What we're doing now is pushing really hard on the BI-1206 pembrolizumab combination as much as we can. We might have already some interesting data that maybe are not in the market yet, but that Merck will see since they are following us closely, and that could then trigger interesting discussions.
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. I think I will use the opportunity here to update or to remind everybody. With BI-1206, obviously subcutaneous, 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 has been just approved as subcutaneous. You could then really think of co-formulating KEYTRUDA subcutaneous and BI-1206 subcutaneous into one injection basically. That could be something very, very interesting. Coming back to your question, 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.
What about an interest from AstraZeneca in combining BI-1206 with Keytruda or their checkpoint?
Absolutely, absolutely. That could be another option. I get this question a lot that some people think, okay, AstraZeneca might, if they're interested, collaborate on non-Hodgkin lymphoma and work on solid cancers. If either party is interested to do that, then probably they will opt for the full program even if they have some specific interest. AstraZeneca absolutely could also then consider, if they think BI-1206 is interesting enough for them to consider collaboration, to also consider other applications besides non-Hodgkin lymphoma. Absolutely.
Okay, thanks. 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 rates 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. You could extrapolate that through the year, a little bit less than SEK 600 million, 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 Haffen Lamm from Stifel. Please go ahead.
Hi team, thanks for taking my questions. My first one would be on the readout 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 on different fronts. Obviously, recruitment is one part of it, but the interest in both studies is significant. Recruitment is going very well, and of course you have better progress than we originally planned. That's the main reason.
Okay, great, thanks. A second question on the BI-1206 triplet combo data. The next data update includes patients that are treated with a higher dose of BI-1206 compared to the last update. I'm thinking, you know, the 225 mg compared to the 150 mg that was mainly used in the preliminary data.
Yeah. Basically, the data that you will see is the continuation of the data that we already presented earlier this year. It will be the same dose, just a higher number of patients.
Okay, go ahead. Thank you.
Thank you, Oscar.
The next question comes from Dan Akschuti from Pareto Securities. Please go ahead.
Hi Martin. Thank you for taking my question. Just one follow up on the previous one. In May of this year you showed that all eight patients in the triplet combo in NHL had shown a reduction of the sum of the target lesions. Even the stable disease ones were moving towards response. 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 13 patients or will we get the full one then still in the first half of next year? Thank you. Is there a possibility to go into phase III as a single agent for BI-1808 in CPCL? Thank you.
Yeah. Starting with BI-1206 first, the full 30 patients will be then at some time point next year. I think roughly by mid next year. What we have now is not the full 30 patients yet, but significantly more than what we have shown in May. On BI-1808, yes, absolutely. The plans and what we have discussed with the regulatories is, you know, single agent pivotal study. I don't have the slide here in the deck and I just have to, you know, memorize what we will do. As I said already earlier, we're currently running the combination with pembro in parallel. We will start with dose optimization and then also preparing for the pivotal studies such that those plans are still the same. We potentially could start a pivotal study for monotherapy first line in 2026.
Okay, thank you very much.
Thank you, Dan.
The next question comes from Arvid Necander from DNB Carnegie. Please go ahead.
Good afternoon and thanks for taking my questions. It's good to see the planned readouts being ahead of schedule. First off, on BI-1206 and the triplet, you seem pretty upbeat, Martin, on response rates being able to move up as patient numbers increase. Can you say anything about your expectations for the readout plan before year end and what would make this readout live up to expectations? You should have a pretty substantial data set on the doublet. We've seen some really nice long lasting responses and we've also seen the duration of the complete responses. 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.
Thank you. 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. The other point obviously is a very high ratio of complete responses. That is what we hope to present to the market. Just remind me of the second part of your question.
That was on the median duration of response for the doublet and whether or not that data is mature enough to present.
Yeah, what we have we can present, obviously. The study did not start that long ago. It looks like what we have seen, but since the study is still relatively young, it's still preliminary data. It looks that we have a similar or the same duration as we already have presented when we came out with the doublet data. Also, to tell everybody, those patients that were in complete response are still in complete response. Now this is more than three years for some of those patients. We don't have the same length with the triplet combination because that just started less than a year ago. We can see that the responses that we get are enduring, basically. 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.
Thank you everybody for participating and also for the good questions. We are, of course, happy and excited that we can update the market earlier than we would. What we projected around BI-1808 single agent T cell lymphoma and BI-1206 immunological lymphoma. I think this is very good and shows the interest in the study regarding the sites that are involved. This is driven by good data, obviously, otherwise we wouldn't have that progress. 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. I'm really looking forward to that, especially partnering. 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, I think we can close the meeting. Thank you very much and talk to you soon.