Welcome to the BioInvent Q3 Report 2026 presentation. During the Q&A session, participants are able to ask questions by dialing pound key five 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, thank you very much, and welcome everybody to BioInvent's Q3 presentation and report. I will start the presentation. I'm Martin Welschof, the CEO, and I would like to start with the events in the third quarter. BI-1808, actually, which is our leading value driver, has gotten a lot of attention. We received FDA Fast Track designation for the treatment of recurring ovarian cancer. Then we had an abstract from modest to meaningful in platinum-resistant ovarian cancer that was accepted for poster presentation at ESMO, and I think we come back to the data a little bit more in detail. Then we also published two scientific papers in peer-reviewed journals. One was in Cancer Research that was highlighting the mode of action, and then we had another publication just a little bit more than a week ago, but I come back to that also later.
There was one presentation actually in the third quarter that was specifically highlighting FcγRIIB and our BI-1206 program. Then, events after the end of the period. The board of directors, as we have announced yesterday evening, have decided to carry out a rights issue of approximately SEK 430 million, which is gross before issue costs, of which SEK 350 million is covered by subscription commitments and guarantee undertakings. Of course, this is still subject to approval at the Extraordinary General Meeting, for which we also have called yesterday evening. We'll adjust the organization to support the prioritized clinical program, so number one, BI-1808, number two, BI-1206, and I come back to that also later throughout my presentation. Then, BI-1808 and Keytruda, we have shown the latest data at ESMO. They used durable responses in heavily pretreated platinum-resistant ovarian cancer.
Actually, the poster was granted the best poster award in the investigational immunotherapy section. Basically, the data is repeating what we have shown at ASCO, but just in a higher number of patients. Then we had to announce that Stefan Ericsson, our CFO, will retire in 2027. Stefan has been with the company for roughly 30 years. He's going in his well-deserved retirement, but we will do that in a very structured way, such that there will be no loose ends, and Stefan also has agreed to support and help us in this transition. That was what I mentioned on the first slide. We had first-in-human BI-1808 data published in Clinical Cancer Research. That was just a little bit more than a week ago, so basically two presentations, two publications covering BI-1808, which is a completely new and unique mode of action.
We are actually the first one developing this mode of action. A little bit more details regarding the financing and then the organization. As already mentioned, we have considered all options, and then at the end, had to land on this rights issue. We might discuss that also in more detail during the Q&A section that is targeting SEK 430 million. This is gross before issue costs. As I mentioned already, before SEK 350 million will be covered by subscription commitments and guarantee undertakings. Of course, this has to be approved during an EGM, which will happen on December 1. As I already mentioned in my introduction, the organization also will be adjusted. We are considering up to 20 FTEs in workforce reduction and keep the focus on 1808, number one, and BI-1206, number two.
I mentioned already Stefan Ericsson's retirement, and then I think also something that is really interesting. Dharminder Chahal has been nominated to return as a board member. Of course, this is also subject to approval at EGM and clearly shows the very strong support that we have from Van Herk. Then a little bit more on the data. This slide summarizes the data that we have just shown at ESMO. As I said already earlier, it's kind of a repeat of the ASCO data, but with a higher number of Ns. A very nice, strong, objective response with one complete response, seven partial responses, a nice disease control of 53%, and several patients are stable, more than 10 months. Six patients are still on treatment at the cutoff in September.
We had less than 5% treatment-related discontinuation out of 81 solid tumor patients, which I think is very important because with most of the other modern treatments, you have a much higher treatment-related discontinuation, which of course is not good for the patients. What is discussed a lot is the progression-free survival, and you can see the numbers down there below. Median progression-free survival as per iRECIST is 10.3 months, and that is probably the most fair consideration because RECIST is really made for chemotherapeutic agent or small molecule compounds, but still 4.1. As a comparison, pembrolizumab alone in the KEYNOTE-100 is 2.1, and also to mention here, the patient population that we are treating is heavily pre-treated platinum-resistant ovarian cancer, median four prior lines, which is a patient population that is very unresponsive. iRECIST captures delayed responses.
The 2.1-month figure is from a different study. That's an indirect comparison. Then duration of response, not bad. The median follow-up is 11.6 months. All in all, a strong data set that we presented at ASCO for 1808. A little bit more on the data here. We show response in a setting where our ORR has previously failed to deliver. When you look at the objective response rate on the left-hand side, you see the combination, 24%. Pembrolizumab alone is 8% and 1808 alone is 6%. You can see that even as a single agent in recurring ovarian cancer, 1808 behaves very much like pembrolizumab, and that's what we always said. Because when we talk to the outside world, we basically say we have the next version of pembrolizumab, the next new IO mechanism.
On the right-hand side, I do not have the time today to go through this in detail, but this is the very good safety profile that we have. This is actually quite impressive considering the heavy pre-treatment history. What are the next steps? First of all, we have FDA Fast Track designation for 1808 in ovarian cancer that was granted in early August 2026. We have it also for relapsed or refractory mycosis fungoides and Sézary syndrome, CTCL, and that reflects a high unmet medical need. We got for the ovarian cancer data at ESMO, the Best Poster Award in the investigational immunotherapy section. The phase I data on the MY was published, and I mentioned that already, Cancer Research and Clinical Cancer Research, which is very, very good, and also additional validation. The next step is then the phase I/IIa Part C.
That is about to start in Q1 2027, and there we will have randomized three arms with 20 patients each. BI-1808 in two different concentrations, 1,000 milligram and 500 milligram, and the control. All will be with pembrolizumab and a weekly paclitaxel plus minus bevacizumab. The first data actually we expect there for the second half of 2027, and that should be very interesting. That is the data that actually corporates as well as large investors are happy to see and want to see. The expected milestones ahead and our focus. In H1 2027, we will start this study that I just mentioned, the Part C. That is the most important value inflection point of the company. We will complete the phase IIa dose optimization for BI-1808 as a monotherapy in CTCL.
Also to remind everybody, this is obviously another strong validator of 1808, and the data that we have positions actually 1808 in the front line as a single agent to treat CTCL. Last but not least, we are also waiting for the first readout, BI-1206 plus Keytruda in first-line non-small cell lung cancer and uveal melanoma. During the second half next year is the first data from the 1808 triplet study in ovarian cancer, and then a potential start of BI-1206 phase IIb pending data and partnering. We have the clear goal and have now engaged with an external party to help us with that, to really push potential partnering by around 1206, but also initiate already discussions around 1808. The focus is very clear. Two targets, TNFR2 and Epstein-Barr virus B, and also to highlight here again.
Those are first-in-class targets. We are the ones developing those targets in oncology at the moment, and that is always a little bit more difficult because you do not have anything that you can get guidance from. 1808 is the current priority, and with the planned rights issue, we aim to take BI-1808 into these randomized and potentially pivotal studies while continuing to develop 1206 with a partner. I think I hand over from here to Stefan. Just flip to the next slide. Go ahead, Stefan.
Thanks, Martin. 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 at SEK 10.8 million in Q3 2026 compared to SEK 3.3 million in Q3 2025. That's SEK 7.5 million higher in Q3 2026. The increase is related to the production of antibodies for customers was higher in 2026. Net sales for January to September 2026 were SEK 37 million. For the same period in 2025, it was SEK 224 million. That's a decrease of SEK 187 million. The decrease is mainly related to that in 2025, we received a $20 million payment when XOMA Royalty acquired future rights for mezagitamab. Prior to that, a $1 million milestone was received in the collaboration. In 2026, we received a one million euro milestone from Bayer, and production of antibodies for customers was SEK 3 million higher in 2026.
Operating cost decreased from SEK 137 million in Q3 2025 to SEK 131 million in Q3 2026. That's a decrease of SEK 6 million. We had quite higher cost in BI-1808 and higher cost in BI-1206 and quite lower cost in BI-1607 and BI-1910. We had somewhat lower personnel cost. For January to September, the decrease of operating cost was SEK 42 million, from SEK 446 million in 2025 to SEK 404 million in 2026. We had quite higher cost in BI-1808 and quite lower cost in BI-1910 and BI-1607, and we had lower personnel cost in 2026. The result for Q3 2026 was minus SEK 119 million, and the result for January to September 2026 was minus SEK 361 million. Liquid funds and current investments end of September 2026 amounted to, in total, SEK 225 million. Please, next slide. Thank you. About the rights issue.
We will get SEK 430 million gross proceed if full subscription of the rights issue. The rights issue is subject to an EGM approval. We will primarily advance BI-1808 in ovarian cancer and secondly, BI-1206 in lung cancer. We will also advance other priority clinical and preclinical projects. We have received subscription commitments of SEK 80 million from the three largest shareholders, Redmile, Van Herk, and Forbion, and also from other shareholders, including HealthInvest. We have also received guarantee undertakings of SEK 270 million, which in total covers SEK 350 million of the gross proceeds. The expected cash runway is to end of 2027, and that's based on the cash position 30th of September, the SEK 225 million, our current business plan, and completion of the part of the rights issue that is covered by subscription commitments, guarantee undertakings, the SEK 350 million.
If full subscription of the SEK 430 million gross proceed, this would give us additional financial flexibility for the prioritized clinical programs. The subscription price will be decided around 25th of November. The EGM will be held on the 1st of December, and the subscription period is from 7th to 21st of December. Over to you, Martin.
Yes. Thank you, Stefan. That brings us to the end of our short presentation, and happy to take questions now.
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 Arvid Necander from DNB Carnegie. Please go ahead.
Good afternoon, team, and thanks for taking my questions. First off, I had a question on the ovarian cancer strategy in light of the developments at ESMO. I guess given the overall rapid progress among competitors here with Rina-S increasingly likely to set a new standard of care and a couple of ADCs with comparable PFS, in slightly different population, of course, but still nevertheless comparable on ADC sort of moving towards the earlier treatment lines. Has this changed your estimate of how 1808 could fit into the treatment landscape here with the planned triplet combo? Secondly, in light of these competitive developments, what do you believe would constitute a meaningful differentiation in Part C? Then secondly, on business development, as you said, further development of BI-1206 is dependent on partnering.
Given the typical lead times here involved in entering a deal, how confident are you in progressing towards a partnership in 2027? Is it fair to assume that the upcoming lung cancer data will be pivotal in advancing these partner discussions? I will start there. Thanks.
Okay. Thank you. I will maybe start, and then Andres, you can chime in. First, discuss around the clinical data and then the positioning of 1808 in recurring ovarian cancer. I think that we are still steadfast regarding the triplet study. We assume that we will, and we have done some analysis around that based on our preclinical validation as well as some modeling. We assume that we can achieve a three-five months increase in PFS based on the current combination, which is, of course, pembro, paclitaxel, and ol. We are targeting a 60% objective response rate. That data should be still very much competitive also with ADCs. With ADCs, you have to keep in mind that they always have a nice objective response, but the duration is still an issue.
But independently from that, we are not competing directly with ADCs because 1808 has a completely different and unique mode of action. We think we can go ahead of an ADC, we can go after an ADC, and potentially also in collaboration or in combination with an ADC, and that is something that we are also currently analyzing and considering. But our step into the Part C is clear, and that is the path forward. Before I come to the BD question, Andres, do you have anything to add to that?
No, I basically reiterate the fact that we will hear a lot about ADCs in the near future. If you were at ESMO this past week, there are in the 20 number of agents in phase III studies or entering phase III studies. However, it is important to note that there is only two payloads. Those drugs are going after basically two treatment types of chemotherapy. We are absolutely not on that ballgame. We are in the IO space, and in the IO space, there is only one approved treatment, and that actually creates an opportunity for BioInvent because our development path is basically an add-on to that treatment. As Martin said, you can go before, you can go after. There is not clarity in the field as to what is going to go before or after.
That will depend on how the patient is feeling, how frail the patients are, some of these IO ADCs are quite toxic. They are very rough chemotherapy. The field is still dealing with that question. The positioning of BI-1808 is unique in that respect. There is no other agent being developed in the way that we are developing BI-1808, and that sets BioInvent apart from any other strategy there. I think that is really important to recognize.
Yeah, thank you, Andres. Then maybe commenting on your second part of the question, which is around business development. As I mentioned earlier in the presentation, we are focusing more now on BI-1808, finishing up a couple of things around BI-1206, and then really actively looking for a partner, which we're actually doing already for a while. But now we've also teamed up with a very reputable outside organization who's helping us with that. It's, of course, always difficult to forecast. The only thing that I can comment here is since we are developing completely new mode of actions, so definitely first in class, this might take sometimes longer than you hope for, because sometimes you have interesting data, but since the mode of action is not known, a lot of partners would like to see a little bit more data.
But in any case, regarding BI-1206, our decision is made, and there are, of course, two independent streams there. One is in the non-Hodgkin lymphoma setting, where we just finish the follow-up and then summarize the data, and then we'll have some discussions with some companies that we already have talked to before, based then on the final data set. Then, of course, Arvid was also referring to the combination with Keytruda, where we expect data, and I think it's not one or the other. It could be as a package. But already in the non-Hodgkin lymphoma, I think we have some discussions ongoing that are only interested in non-Hodgkin lymphoma, not necessarily the solid cancer, and vice versa. So we'll see. We push hard. Difficult to forecast.
Great. Thank you, Martin. I'll jump back in the queue.
Thank you.
The next question comes from Clemence Thiers from Stifel. Please go ahead.
Hi. Thank you for the presentation, and thanks for taking question. Just one on my side. Could you precise what is included in your cash runway through end 2027, assuming on the covered part, it got initiation and first readout of Part C, readout of BI-1206 in uveal and lung cancer. Is there anything else, next step, like trial initiation that are in it? Any color would be great. Thank you.
Yeah, I can maybe start, and then Stefan, you can add to that. It depends, of course, how much financing we will raise. Now I am just starting from the minimum scenario, which is basically a little bit more than $30 million. That would cover the initiation of the Part C for BI-1808, and would include an interim readout of 30 patients. Since we expect a clear signal, we have seen a clear signal already in the doublet, and we expect also a clear signal there. That should give us a good indication. It would also, of course, cover the finalization of the BI-1206 in non-Hodgkin lymphoma, basically to finish all the follow-up and data analysis. Then the first readout in first-line non-small cell lung cancer and uveal melanoma, but it would not cover any further work of BI-1206 in that setting.
It would also not cover any additional clinical work for BI-1808 in other solid cancer indications because it is not in the public domain yet. But we see also some interesting other signals that we would like to follow up on. Also would cover, I forgot that when I talked about BI-1808, to round up the CTCL data. But Stefan, maybe you can give a little bit more detail.
Yeah. What I can say, with the liquid funds we have currently, we are financed to latter part of Q1 2027. That is in line with what we have said before. With the secured part of the rights issue completed at SEK 350 million in gross proceeds, we are funded until, like Martin said, end of 2027.
Okay. Perfect. Thank you very much.
Thank you.
The next question comes from Chien Lee from Pareto. Please go ahead.
Hi, Martin. Congrats with securing the financing. Just two quick questions from me. With the [pass in ovarian cancer, as it is obviously the next inflection point, how will you handle the use of bevacizumab across different arms, and will the randomization be stratified by that? The second question is on BI-1206. There seems to be a bit delay in the readout in non-small cell lung cancer and uveal melanoma. Now you are guided data in first half 2027. Could you provide a bit of color on what caused the delay? Is it the enrollment side or follow-up? Thank you.
Yeah, maybe I would start and then also, Andres, you can fill in. I leave the BI-1808 completely to Andres, but on the BI-1206, the delay is basically that we want to mature the data a little bit more. Recruitment actually was quite good. We have recruited the part for the uveal melanoma and at least one-third already for the non-small cell lung cancer. There will be no problem for the first readout as indicated now. As I said, the main reason for that is that we want to let the data a little bit more mature. That is related to the mode of action, which is immunomodulatory, and you know that always needs a little bit more time than other mode of actions. Maybe, Andres, then you can comment on BI-1808 regarding Chien’s questions.
Yes. We will do exactly what Merck did in the KEYNOTE-B96. We will provide bevacizumab, and that will be used at the discretion of the investigator. We anticipate a similar usage as what they had in their study. That was in the order of 70% of the patients received bevacizumab. Yes, the arms will be equilibrated for usage of bevacizumab. So very much in line to what KEYNOTE-B96 are. The goal with this study is to demonstrate that BI-1808 actually adds a lot, as Martin mentioned, to the outcome if you were to be given on the pembro and paclitaxel plus or minus bevacizumab. The goal will be very similar to the way, what they did.
Okay. Thank you for taking my questions.
Thank you.
The next question comes from Richard Ramanius from Redeye. Please go ahead.
Hello, good afternoon. I have some questions relating to the rights issue, but let's start with one on the pipeline. How do you plan to bring BI-1808 and CTCL forward?
Yeah, so maybe I can start with that, Andres, and then you can add. The current plan is to finish the ongoing dose optimization, and then get it ready for potential pivotal study for it during the second half of next year. But obviously we will not run that pivotal study on our own. That should be done with a partner.
I guess it would be the same partner as for ovarian cancer?
Yes. That would be the ideal situation because otherwise, you will not get out the value that is really in the program. Absolutely.
Then some questions on the rights. First, I have a kind of technical question. Is it possible for you to say if the subscription price would be set by a TERP discount or a volume-weighted average price formula?
It's a TERP discount, as I think it says in the launch press release.
Yeah. That is what I suspected. What is the plan for the long-term funding after 2027?
Yeah. Basically, with the minimum amount, we will just go to that time point as we have said. Then of course, the idea is, as we also said, I think in the press release, maybe to combine it with another directed that would then lead to the full data set in the triplet trial, 60 patients. Then of course, the focus is now even more than it was before on partnering.
A logical follow-up question, I guess it was difficult to find investors for a directed issue right now then.
Once again, I did not get that accurately. Sorry, Richard.
Was it difficult to find investors for a directed share issue for this funding round?
Yes. Basically, what you have to give a little bit broader perspective here. You know that what we are developing is first in class. We are the first ones showing the potential application of BI-1808 or basically the target of TNFR2. The problem with that is the current markets, they are really mostly focused on best in class, not so much on first in class. The interest is high, so we have no problems to get meetings with corporates as well as with large institutional investors. I think the interest is actually getting better. What they will have to see in order to get comfortable or more comfortable is more data.
I think we did a first step with the ESMO presentation, because one of the questions was, okay, at ASCO, when we have shown what we have shown, okay, this is in 24 patients, I think it was, show it in more patients. This we have done, which is really, really good. Nothing has changed regarding the quality of the data, even in a higher set or larger set of patients. That is obviously now the main part. I think there is just one or two patients that still have to be read out, but I think nothing would change there. That is number one. Then, of course, also since this setting is not the one that you will use in the clinic, the setting will be then the triplet.
I think there is also quite some interest from corporates as well as from large institutions to see the first 10, the first 20 patients in the triplet setting. I think that will drive, in case the data comes out as we project, a lot of interest. That is the reason why we had to do what we are doing at the moment.
Okay, good. Thanks, Welschof. Thanks for answering my questions.
Thank you, Richard.
The next question comes from Sebastiaan van der Schoot from Kempen. Please go ahead.
Hey, guys. Good afternoon, and congrats on the extension of the runway to year-end 2027 and also the ESMO presentation. I was particularly wondering regarding the patient population that you are going to enroll for Part C. Looking at the competitive space with the ADCs that are also moving into earlier lines, are you thinking about recruiting earlier patients? What are you thinking about the proportion of patients with clear cell carcinoma versus those with high-grade serous adenocarcinoma? What is kind of the delta or the OR that you are looking for the Part C data, the initial results in H2? Thank you.
Andres?
Yes. Hi, Sebastiaan. The idea is to reproduce what KEYNOTE-B96 and this allows me the opportunity to stress this fact that in particular in ovarian cancer, every line of treatment decreases significantly the overall survival. When you look at the clinical studies that have been conducted, our patient population, the one that presented at ESMO is a much less responsive patient population. When I mean much less is really, really much less responsive. To see those results in that heavily pretreated patient population is quite significant. What we will do now is we will take the exact same patient population as that of KEYNOTE-B96, so allowing only two previous lines. Obviously one thing that comes to mind, and I think that may be why you're asking the question is, will that have a difficulty in recruitment and enrollment of patients?
What I can tell you is that during ESMO, I met with a number of different clinicians from different European countries, and they were all very enthusiastic about this and actually requesting that we open their side. One of the clinicians said, "I will have no issues putting early patients into your study because of the huge medical need." Again, because when you treat your patient with an ADC, it doesn't make a lot of sense to follow up with another ADC. That is something that people are failing to recognize, but it is something that is determinant. I think there was another part to your question.
Yeah.
Yeah. Clear cell versus-
So-
Yeah.
Yeah. The clear cell carcinoma versus the high grade.
Yeah. Right. Clear cell carcinoma is a very interesting. It creates an opportunity, actually, because while high-grade serous responds better to chemotherapy, clear cell carcinoma, it responds very poorly to chemotherapy. In that context, the medical need for that indication is significantly higher than for the others. In that context, seeing the results that we are seeing in that specific indication is important and will create an opportunity, an additional opportunity. Our goal is to, the study has no restrictions in terms of what patients will come from each subtype. But the idea is to enrich slightly in terms of clear cell, that will probably give us a good understanding of the responses in that specific indication. Because if we continue seeing what we are seeing in that specific patient population, that might create an even clearer and shorter path to approval after this study.
We will enrich for that patient population, but it is very likely that the large majority will be high-grade serous.
Sebastiaan, does it address your question?
Hi, guys. Sorry, I was still muted. Regarding the ORR level that you are expecting for the cohort C, the initial results in H2 of 2027, what is kind of the benchmark that you are setting for yourself?
I think that the objective response rate, if you look at KEYNOTE-B96, their objective response rate was 53%. I would assume that adding 1808 will also contribute, so somewhere around a high 50% or 60%, maybe we will get over that bar, and that will already be very impressive. However, as I said before, the key endpoint for this, where the battleground will be, and you already see it with the ADCs, is PFS. The PFS in the next coming readouts will be essential. I think that's where we will have, I think, a huge increase. And that's where, according to our modeling, we expect at least three months addition to PFS. If you look at what pembrolizumab added to paclitaxel, it was basically less than a month.
Our modeling suggests that we will at least add three months to the PFS, and because of the safety of the treatment, it is very likely that we will have an impact on overall survival, despite the fact that we won't be able to measure that in the next study. But a substantial addition of PFS is the key thing to watch, and that's where we think that BI-1808 will differentiate itself from all other agents.
Great. Thank you very much, guys.
Thank you, Sebastiaan.
There are no more questions this time. I will hand the conference back to the speakers for any closing comments.
Yeah. Thank you, everybody, and thank you to all the people that were asking questions. I think we are now at a very pivotal moment of the company, and obviously with the rights issue, we have the chance to turn the most important and next data point, as I already mentioned a little bit earlier, during the Q&A. What is important to remember is that we are developing first in class, and that, unfortunately, takes a little bit longer and also requires more data. But I think with the rights issue, we are well-equipped to tackle that and then hopefully to unlock the full value. With this, I would like to close and thank you very much for the attention.