BioInvent International AB (publ) (BINV) Earnings Call Transcript & Summary

[Operator Instructions] Now I will hand the conference over to the speakers, CEO, Martin Welschof; and CFO, Stefan Ericsson. Please go ahead.

Thank you very much, and welcome, everybody, to our year-end report 2024. And I'm Martin Welschof, the CEO. I'm together here with Stefan Ericsson, our CFO. And for the first part, I will run you through a quick summary of what has happened and will end at the end of the presentation with an outlook. And of course, then Stefan also will have his slides where he'll cover the finance. which will be a little bit towards the end. And then, most likely, we'll also have during the Q&A session, our Chief Medical Officer, Andres McAllister with us. So, I will go through the presentation, our forward-looking statements. And I will start with a quick year-end report summary and we'll start with the events in the fourth quarter. And as you probably already know, so we enrolled the first patients in our 1607 study, which is our second anti-FcgammaRIIB program and we're focusing on patients with unresectable or metastatic melanoma. So we're very happy that we could kick that off because we believe this is a very interesting combination study. Then also, we are very happy that we could expand our management team. So we appointed Ashley Robinson as our SVP of Strategy and Finance because we want to increase our exposure in the U.S. and Ashley has been already quite active and had a lot of meetings, and we look forward to have even more meetings in the near future. Then we had a couple of things that happened after the end of the period. So, we had our first positive data in our 1206 triplet study where we combined 1206 with rituximab and Calquence for the treatment of non-Hodgkin lymphoma, and we are focusing there on patients, of course, that do not respond anymore to anti-CD20--based therapy. And we had a nice data. So, basically, it's very early days, but 2 patients, both are responding; 1 complete response and 1 partial response, and I'll come back to that in a little bit more detail later. Then we also had the first Phase I data out for our second anti-TNF receptor 2 program BI-1910 as a monotherapy for the treatment of solid tumors, and that was also -- I was also very satisfied with that study because we had a very successful dose escalation and saw first interesting signals. Then, of course, also on the corporate side, we achieved a couple of interesting milestones. So we achieved the ISO 26000 Verification, highlighting our commitment to ESG and transparency, of course. And then also important, always runs on the side, but I think it's very important because this composition of matter patent for the BI-1808 has been granted in Japan and it actually also covers the use of the antibody in the treatment of cancer. So, we're also quite happy about that. So with this quick summary, I will now go through the various programs a little bit more in detail. Before I do that, I also want to highlight really the development of the whole portfolio during 2024. And what you see here on this slide is all the programs, 1910, 1808, 1206 and 1607, where they were standing in 2023. This is on the upper part of the slide. And on the lower part of the slide, you see them in the programs that we're running with our collaborators. You will remember that we have our own proprietary portfolio, but based on our R&D collaborations that we have done with several, we also have a portfolio that has been generated with our collaborators such as Takeda, Mitsubishi, Bayer/Hope, et cetera. So, going then to the next slide, which basically will show you the shift that we have achieved in 2024. So, now we really have, with 1206 and 1808, 2 programs within Phase II. 1808 -- and there I'm talking 1808 single agent and BI-1206 in non-Hodgkin lymphoma, but also 1808 in combination with pembro has now started Phase II. And then 1910, 1206 with pembrolizumab, 1607 and BT-001, they are now in Phase I, and I will come back to that later in a little bit more detail. And overall, this is a very, very active and strong development. We're happy that we could move the whole portfolio like this. And then also with the collaborators, there has been a change. So you can see that the Takeda antibody as well as the Mitsubishi antibody, they're now ready for Phase III clinical trials, which I think is also very strong validation again for our platform generating antibodies that can go that far. And what I always say is not only BioInvent using the BioInvent platform, but also companies such as Takeda and Mitsubishi that do that successfully. Now, I will go from program to program. Before I do that, just a very quick overview again. And you can see that we have a very strong proprietary clinical pipeline with multiple value drivers, which we think is very important. And you see on the left-hand side, the 3 targets that we're currently focusing on. Mainly, we're focusing on our TNF receptor 2 and FcgammaRIIB platform. And so both programs have 2 different compounds that are currently in development, and the lead for TNF receptor 2 is 1808, which is now in Phase II. And then the second antibody that we have there is 1910, and that has now successfully finished Phase I. And then on the FcgammaRIIB side, 1206, obviously, the lead in non-Hodgkin lymphoma and solid tumors and in non-Hodgkin lymphoma, we are also now in Phase II. And then 1607 in solid tumors as well as 1206 in solid tumors is still in Phase I. Then we also have a collaboration ongoing with Transgene, which is a 50-50 joint venture. And there, we use our proprietary anti-CTLA-4 antibody in the Transgene Oncolytic Virus platform and that program also has done -- has progressed quite well. But as I said already, so our main focus is on our 100% proprietary programs, which is the programs on our TNF receptor 2 and FcgammaRIIB. And for the first time since a couple of years, we have now 2 programs in Phase II. So with 1808 and there we have seen strong single-agent data and for 1206 in non-Hodgkin lymphoma as well, where I can say that we have 2 compounds that are active and safe. So that is a very good achievement, a very strong achievement. And I think there, we can foresee that we have further very, very interesting updates during this year that can drive multiple interesting things, but we might come back to that later in more detail. So then going program by program, very quickly. Anti-TNF receptor 2, I mentioned 2 different compounds. 1808 is the lead, and you see the summary here on this slide. So we could show in solid tumors a couple of responders. So, we had a complete response in ovarian cancer, a partial response in GIST. In addition, actually, we also had a responder in lung cancer. Unfortunately, that patient developed a secondary cancer, and that's why we can't mention this patient as a responder, but I would still count him like this. And in addition, we had a couple of patients with stable disease. So that was the situation in solid tumors, and that data has been generated during the dose escalation. Then on the other side, and that was data that we then presented at the end of last year in CTCL because what we are targeting is both solid tumors as well as liquid tumors. So, tumor on T cells. And there we saw actually out of 4 evaluable patients -- out of 4, basically 3 strong partial responders and 1 patient with stable disease. And this goes without saying, all patients have been heavily, heavily pretreated and still we see good single agent activity, which is quite stunning. And we did some analysis of the early development work around pembrolizumab, and with this response that we see, so responders in solid cancer such as ovarian and GIST as well as liquid cancer CTCL. And then, of course, also we have the lung cancer patient, we are in the same ballpark as pembrolizumab in its early development stages. So I think this is a very exciting time to be in and of course, also gives a lot of hope for further clinical development. Then, besides 1808, so we have 1910, where we have started the Phase I. We finished the dose escalation. And we also saw there already interesting signals. First of all, I should say both compounds, 1808 and 1910 are very safe. So there are no DLTs, nothing, so completely clean. And in 1910, what we saw so far as a best response is 6 stable disease out of 12 evaluable patients. I think that is also a first interesting sign. And then, of course, we are now moving forward or have already moved forward and we will have more data on 1910 during the second half of this year. For 1808, I forgot to mention on the previous slide, we'll have the next update by mid this year. So that's not far away, and everybody should stay tuned because I think that will be very interesting and exciting. Then moving into the anti-FcgammaRIIB platform, 2 different compounds; 1206, as already mentioned, we're currently developing in non-Hodgkin lymphoma in the triplets combination with rituximab and acalabrutinib. And then also in solid cancers in combination with pembro. In the non-Hodgkin lymphoma, we are targeting patients that do not respond anymore to Anti-CD20 based therapy. In the solid cancer, we are targeting patients that have received 1, 2, 3 regimens of either anti-PD-1 or anti-PD-L1 containing regimens and they do not respond anymore -- and I think both settings are quite interesting. And then the second candidate is 1607, where we just started clinical development. So I will mostly focus on 1206. So, starting then with the triplet. This is a very interesting positioning. Maybe before I talk about the data, just to mention again, so what we're trying to establish here is a treatment, which is as efficacious as the best bispecifics or CAR-Ts, but no toxicity. And I think that is something very interesting, keeping in mind, for instance, in the U.S., most of the cancer patients are treated locally and not in the big centers. And those local treatment hospitals, they don't want to deal with cytokine tox and any other toxicity. So in that sense, this is very competitive, and the kickoff has been really great. So published in January. So, the first 2 patients both responded. So we have a complete response and a partial response. And I think I mentioned already that we have additional data by mid this year. And hopefully, I can tell at that time point, a similar overall response rate because what we're expecting or we want to achieve is a [ 75% ] overall response with the highest -- high degree of complete response is around 50%. And then, of course, to have a convenient and very safe treatment. And keep in mind, of course, BI-1206 is a subcutaneous formulation that we have generated ourselves, which, of course, is also very convenient, which means you don't have to go to transfusion centers; and also be efficacious, 1 to 2 hours versus just a couple of minutes. So, very promising. And again, here, the next update will be by mid this year. Then moving into the solid cancer side. There, we have seen very promising efficacy signals. So, with a complete response approximately 2 years, and a partial response in uveal melanoma, and the other one was in cutaneous melanoma, and then also 8 patients with long-lasting stable diseases in some cases. So, also well tolerated in this very heavily pretreated population. And just to remind everybody again, so of course, all the cancer patients that we're currently treating are heavily pretreated, right. So, -- and still we see what we see. So this is actually quite promising. And also for the solid cancer, BI-1206 setting, we will have further Phase I data by mid this year. So by mid this year, we'll have more single-agent data for 1808, more triplet data for 1206 in non-Hodgkin lymphoma and more combination data with pembrolizumab in solid cancers. And one comment here on the side. So, keep in mind that we have, of course, very good supply agreements and collaboration agreements with a number of parties. So I think we have 5 with Merck and 1 with AstraZeneca. And especially here, in this case, for BI-1206 on the non-Hodgkin lymphoma, we have a supply agreement and collaboration agreement with AstraZeneca. And on the solid cancer, we have a supply and collaboration agreement with Merck. And that, of course, once we are getting in the interesting zone of data generation could lead to very interesting dynamics and discussions. So, then coming to the 1607, and this is something that just has started. What we're trying to do here is basically to enable the combination of ipilimumab and pembrolizumab, which oncologists would really like to do, but it's very difficult because of toxicity. And what we have seen preclinically, if you combine with BI-1607 that we can reduce the dose of ipilimumab, still have the activity and of course, then also less toxicity. So, it's a very interesting setting. And we are focusing here on patients with unresectable or metastatic melanoma. And we just kicked that off, and we expect the first data of this triplet during the second half, probably at the end of second half of this year. So before I just briefly talk about anti-CTLA-4, I just want to stop here for a moment and look at all the clinical responses that we have in our lead programs. Obviously, most of it in 1808 and 1206 because those are the most advanced. So, starting on -- beginning on the left-hand side of this slide, so 1808 as a single agent, so we saw complete response in ovarian cancer, partial response in GIST, 9 patients with stable disease. As I mentioned already earlier, I would also count in here the lung cancer patient. And then, of course, in addition, in the liquid cancer, the CTCL cohort, out of 4 patients, we saw 4 responders, 3 partial and 1 patient with stable disease. So it's a very, very good situation to be in. 1910, so far is a little bit earlier. Out of 12 evaluable patients, 6 patients with stable disease. Then on the 1206 non-Hodgkin lymphoma side, the subcu formulation. There we have 2 complete response, 3 partial responses and 3 patients with stable disease, 9 evaluable patients, so super cool. And for the IV formulation, 5 complete responses, 1 partial response, 6 patients with stable disease out of 17 evaluable patients. So, also as a doublet, very, very efficacious and very well tolerated, of course. And then the triplet, of course, which is now most important in this development stream, 2 evaluable patients, 2 responders; 1 complete, 1 partial. So I think also very promising. And I'm really excited to see what we have by midyear. Then on the 1206 pembro side; 1 complete response, 1 partial response and 8 patients with stable disease out of 24 evaluable patients. So, all in all, I think for a company of our size, we are in a very, very good position, a very strong position. All programs that we have started are quite interesting. And of course, now with 1808 and 1206, we'll reach a time point by mid this year where we're really talking, which means then we are in Phase II and have more mature Phase II data that can drive partnering discussions and will drive partnering discussions that are already ongoing, plus, of course eventually financing and. And then 1910 and 1607 will be a little bit later in this year. So a very nice portfolio delivering on all fronts basically. Then, very briefly at the end, the anti-CTLA-4 oncolytic virus. As I said, so this runs a little bit on the side. Our main focus are on the programs that I just have discussed. But also here, we have made a good progress, and that was actually published at ESMO in September 2024. We could show that with BT-001, we can induce tumor regression in patients who failed previous anti-PD-L1 treatments and in the patient with a heavily pretreated leiomyosarcoma, a very difficult to treat patient -- cancer indication, we could see that BT-001 was able to modulate the tumor microenvironment and it's turning a cold tumor into a hot tumor. So I think very, very interesting data indeed as well. So, that leads then to the financial overview before -- then at the end, I will conclude with the milestones for this year. So Stefan, please go ahead.

Thank you. I will present the financials for Q4 and the full year 2024. All amounts are in SEK million, unless otherwise mentioned. Net sales were SEK 21.4 million in Q4 2024 compared to SEK 15.3 million in Q4 2023. That's SEK 6 million higher in Q4, 2024. The increase is related to that research funding was SEK 7 million lower in Q4 2024 and production of antibodies for customers was SEK 13 million higher in Q4 2024. And net sales for the full year 2024 were SEK 44.7 million. For the same period in 2023, net sales were SEK 71.5 million. That's a decrease of SEK 27 million. And the reasons for the decrease is that we in 2023 had a $1 million milestone from Exelixis. We had -- research funding was SEK 33 million lower in 2024 and production of antibodies for customers was SEK 17 million higher in 2024. Operating costs increased from SEK 126 million in Q4 2023 to SEK 147.2 million in Q4 2024. That's an increase of SEK 21 million. We had higher costs in BI-1607, BI-1206 and somewhat higher cost in BI-1808 for production of antibodies for customers. We had a little bit lower cost in BI-1910, and we had slightly higher personnel costs in Q4 2024. For January to December, the increase of operating cost was SEK 74 million from SEK 441 million in 2023 to SEK 516 million in 2024. During the period, we had quite higher cost in BI-1808, BI-1607 and BI-1206 and a little bit higher cost in BI-1910 and for production of antibodies for customers. And personnel costs in 2024 were quite higher compared to 2023. The loss for Q4 2024 was minus SEK 116.9 million, and we had a loss for the full year 2024 of minus NOK 429.4 million. Liquid funds and current investments end of December amounted to in total SEK 867 million. And based on current plans, we are financed until mid-2026. That cash run could be extended if we get upfronts from new actions -- from new collaborations. Okay.

Thank you, Stefan. So I assume you were done. Then the only thing outstanding before we have our Q&A is then the key catalysts for 2025. I think mostly I mentioned that already, but it's always good to summarize it again. So, as I mentioned, so we're really looking forward to the update mid this year because then we see further 1808 single-agent Phase II data. And based on the response that we've seen so far, we are quite hopeful. Then we have 2 updates on 1206; 1 in non-Hodgkin lymphoma and the triplet, where we have seen so far 2 out of 2. Again, also here, we hope for a very high and interesting response rate. And then also we'll see an update on BI-1206 in solid tumors in combination with pembro. So that will be by mid this year. And then, during the second half of this year, so we have further 1808 data. In this case, it will be a combination with pembrolizumab. Then 1910, we would see single agent Phase IIa data and hopefully solid tumor pembro combo Phase I data. And then last but not least, by the end of the year most likely, the first triplet data for 1607 in combination with pembrolizumab and ipilimumab. So I will stop here, and we will be ready for Q&A.

[Operator Instructions] The next question comes from Richard Ramanius from Redeye.

I'll keep it short. I just have 2 questions about the -- I'll start with BI-1206, the combination with [ rituximab ] the subcutaneous one. So, what's the status of that? And what's the status of the CASI collaboration?

So, you were a little bit disrupted, Richard, but -- and please correct me in case I misunderstood you. So, your first question was what the status is for the subcutaneous of 1206, right?

In combination with rituximab in lymphoma, yes.

Yes, yes, yes, exactly. So -- and maybe I was not clear enough. Of course, our focus now is on the triplet, right? So we -- that's the main focus that we're running. And I don't know whether we have Andres here because I'm not 100% sure whether we do further recruitment also in the doublet. Andres, do you want to comment on that?

Yes. So I'm not sure I understand the question, but the recruitment in the doublet is basically stopped because we are now moving into the triplet. The data in the doublet is very exciting, and that has actually primed us to introduce the BTK inhibitor. And now that we have the BTK inhibitor, the study has -- it's been recruiting. And as Martin said, we have a very nice trajectory in terms of responses and what we're already seeing in the patients that we're recruiting. I hope that was -- that answered the question.

Yes. I think that was absolutely correct, Andres. Thank you very much. And the other question, I think, was about the collaboration. Do you refer to the CASI collaboration?

Yes.

Anders, do you want to address that where CASI is, because they had some updates last year.

Yes, yes. So, CASI is progressing really well. They're about to finish their IV part. They basically have some patients still being treated in the study and the responses that they observe are very similar to what we have observed and the pharmacokinetics and pharmacodynamics are very similar. So that's very encouraging because it tells us that in an Eastern population, the antibody behaves very much like it does in Western ethnicities. So that's important. They will now move forward with the subcutaneous formulation. So we're basically very much aligned in what we're trying to achieve.

Thank you, Andres.

There are no more questions at this time. So, I hand the conference back to the speakers for any closing comments.

Okay. Thank you very much. So not much remains to be said. So I think I have covered probably everything. So, what I could say is that looking here at the milestone slide that we have a really, really rich portfolio. I think this is something really outstanding for BioInvent. And as I said earlier, when we were looking at the sides with the different responses, I think also all the programs are performing super strong and super nice. And I think this year will be just a continuation of the second half of last year where we were quite active. And as both have said, myself as well as Andres, so for 1808 and 1206 mid this year. should be really very, very interesting, and we expect additional responses. But then also during the second half, even the programs that are not that advanced, 1910 as well as 1607 should be also quite interesting. So, from my perspective, and I think I speak for the whole management, even though the whole company, we're all very, very excited and very happy with the progress that we had so far. And on the side, also we had a Board meeting yesterday, and we went deeply into the portfolio and also our strong institutional investors, such as Forbion, HBM representative, Redmile and of course, Van Herk are super, super happy, Omega with the progress that we have. And they, of course, see a lot of different companies here in Europe as well as in the U.S. So summary -- in summary, I think we're in a very good position for a very exciting year. Thank you very much.