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Earnings Call: Q4 2024

Feb 27, 2025

Operator

Your line is muted. Call recording is on. For the first part of the conference call, the participants will be in listen-only mode. During the questions & answers 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.

Martin Welschof
CEO, BioInvent International

Thank you very much, and welcome everybody to our year-end report 2024. I'm Martin Welschof, the CEO, and I'm together here with Stefan Ericsson, our CFO. For the first part, I will run you through a quick summary of what has happened, and we'll end at the end of the presentation with an outlook. Of course, then Stefan also will have his slides where we'll cover the finance, which will be a little bit towards the end. Most likely, we'll also have, during the Q&A session, our Chief Medical Officer, Andres McAllister, with us. I will go through the presentation, our forward-looking statement, and I will start with a quick year-end report summary. We'll start with the events in the fourth quarter.

As you probably already know, we enrolled the first patients in our BI-1607 study, which is our second anti-FcγRIIB program, and we're focusing on patients with unresectable or metastatic melanoma. We are very happy that we could kick that off because we believe this is a very interesting combination study. We are also very happy that we could expand our management team. We appointed Ashley Robinson as our SVP of Strategy and Finance because we want to increase our exposure in the U.S. Ashley has been already quite active and had a lot of meetings, and we're looking forward to having even more meetings in the near future. We had a couple of things that happened after the end of the period.

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. We are focusing there on patients, of course, that do not respond anymore to anti-CD20-based therapy. We had nice data, so basically, it's very early days, but two patients, both are responding, one complete response and one partial response. I'll come back to that in a little bit more detail later. We also had the first phase I data out for our second anti-TNFR2 program, BI-1910, as a monotherapy for the treatment of solid tumors. We were also very satisfied with that study because we had a very successful dose escalation and saw first interesting signals. Of course, also on the corporate side, we achieved a couple of interesting milestones.

We achieved the ISO 26000 verification, highlighting our commitment to ESG and transparency, of course. Also important, always runs on the side, but I think it's very important because this composition of matter patent for BI-1808 has been granted in Japan, and it actually also covers the use of the antibody in the treatment of cancer. We are also quite happy about that. 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. 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 then 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, etc. Going then to the next slide, which basically will show you the shift that we have achieved in 2024. Now we really have, with BI-1206 and BI-1808, two programs within phase II. BI-1808, and they are talking BI-1808 single agents and BI-1206 in non-Hodgkin lymphoma. Also, BI-1808 in combination with pembrol has now started phase II.

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. Overall, this is a very, very active and strong development. We are very happy that we could move the whole portfolio like this. Also with the collaborators, there has been a change. You can see that the Takeda antibody as well as the Mitsubishi antibody, they are now ready for phase III clinical trials, which I think is also very strong validation again for platform-generating antibodies that can go that far. What I always say is not only BioInvent using the BioInvent platform, but also companies such as Takeda and Mitsubishi that do that successfully. I will go from program to program. Before I do that, just a very quick overview again.

You can see that we have a very strong proprietary clinical pipeline with multiple value drivers, which we think is very important. You see on the left-hand side that there are three targets that we're currently focusing on. Mainly, we're focusing on our TNFR2 and FcγRIIB platform. For both programs, we have two different compounds that are currently in development. The lead for TNFR2 is BI-1808, which is now in phase II. The second antibody that we have there is BI-1910, and that has now successfully finished phase I. On the FcγRIIB side, BI-1206 is obviously the lead in non-Hodgkin lymphoma and solid tumors. In non-Hodgkin lymphoma, we're also now in phase II. BI-1607 in solid tumors, as well as BI-1206 in solid tumors, is still in phase I.

We also have a collaboration ongoing with Transgene, which is a 50/50 joint venture. There we use our proprietary anti-CD84 antibody in the Transgene oncolytic virus platform. That program also has progressed quite well. As I have said already, our main focus is on our 100% proprietary programs, which is the co-stimulatory TNF receptor II and FcγRIIB. Now for the first time since a couple of years, we have two programs in phase II. It is 1808, and there we have seen strong single-agent data for 1206 in non-Hodgkin lymphoma as well, where I can say that we have two compounds that are active and safe. That is a very good achievement, a very strong achievement. I think there we can foresee that we have further very, very interesting updates during this year that can drive multiple interesting things.

We might come back to that later in more detail. Going program by program, very quickly, anti-TNFR2, I mentioned two different compounds. BI-1808 is the lead. You see the summary on the slide. We could show in solid tumors a couple of responders. We had a complete response in ovarian cancer, a partial response in gastrointestinal stromal tumor. In addition, actually, we also had a responder in lung cancer. Unfortunately, that patient developed a secondary cancer, and that is why we cannot mention this patient as a responder, but I would still count him like this. In addition, we had a couple of patients with stable disease. That was a situation in solid tumors, and that data has been generated during the dose escalation.

On the other side, that was data that we then presented at the end of last year to the CTCL because what we're targeting is both solid tumors as well as liquid tumors, so tumor T cells. There we saw actually out of four available patients, four out of four, basically three strong partial responders and one patient with stable disease. This goes without saying, all patients have been heavily, heavily pretreated, and still we see the single-agent activity, which is quite stunning. We did some analysis of the early development work around pembrolizumab. 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 patients, we are in the same ballpark as pembrolizumab in its early development stages.

I think this is a very exciting time to be in, and of course also gives a lot of hope for further clinical development. Besides 1808, we have 1910, where we have started the phase I. We finished the dose escalation, and we also saw there were the interesting signals. First of all, I should say both compounds, 1808 and 1910, are very safe. There are no DLTs, nothing, so completely clean. In 1910, what we saw so far as a best response is six stable disease out of 12 available patients. I think that is also a first interesting sign. 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. That is not far away, and everybody should stay tuned because I think that will be very interesting and exciting. Moving into the anti-FcγRIIB platform, two different compounds, 1206, as already mentioned, we're currently developing non-Hodgkin lymphoma in the triplets in combination with rituximab and acalabrutinib. Also in solid cancers in combination with pembrolizumab. 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 one, two, three regimens of either anti-PD-1 or anti-PD-L1-containing regimens and then do not respond anymore. I think both settings are quite interesting. The second candidate is 1607, where we just started clinical development. We'll mostly focus on 1206.

Starting then with the triplet, this is a very interesting positioning. Maybe before I talk about the data, just to mention again, what we're trying to establish here is treatment which is as efficacious as the best bispecifics or CAR-Ts, but no toxicity. 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. Those local treatment hospitals, they don't want to deal with cytokine storms and any other toxicity. In that sense, this is very competitive. The kickoff has been really great. It was published in January. The first two patients both responded. We had a complete response and a partial response. I think I mentioned already that we have additional data by mid this year.

Hopefully, I can tell at that time point a similar overall response rate because what we're expecting or want to achieve is a 75% overall response with a high degree of complete responses around 50%. Of course, to have a convenient and very safe treatment. 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. Also, the application is one to two hours versus just a couple of minutes. Very promising. Again, here, the next update will be by mid this year. Moving into the solid cancer side, there we have seen very promising efficacy signals. There were complete responses approximately two years, then partial response in a uveal melanoma.

The other one was in cutaneous melanoma, and then also eight patients with long-lasting stable diseases in some cases. Also well tolerated in this very heavily pretreated population. Just to remind everybody again, all the cancer patients that we're currently treating are heavily pretreated, right? Still we see what we've seen. This is actually quite promising. Also for the solid cancer, BI-1206 setting, we will have further phase I data by mid this year. 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. One comment here on the side, keep in mind that we have, of course, very good supply agreements and collaboration agreements with a number of parties.

I think we have five with Merck and one with AstraZeneca. Especially here in this case for BI-1206, on the non-Hodgkin lymphoma, we have a supply agreement and collaboration agreement with AstraZeneca. On the solid cancer, we have a supply and collaboration agreement with Merck. That, of course, once we are getting in the interesting zone of data generation, could lead to very interesting dynamics and discussions. 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. What we have seen preclinically, if you combine with BI-1607, is that we can reduce the dose of ipilimumab, still have the activity, and of course, then also less toxicity. It's a very interesting setting.

We are focusing here on patients with unresectable or metastatic melanoma. We just kicked that off. We expect the first data of this triplet during the second half, probably at the end of the second half of this year. Before I just briefly talk about anti-CD84, 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. Starting on the left-hand side of this slide, 1808 is a single agent. We saw complete response in ovarian cancer, partial response in GIST, nine patients with stable disease. As I mentioned already earlier, I would also count in here the lung cancer patient.

Of course, in addition, in the liquid cancer, the CTCL cohort, out of four patients, we saw four responders, three partial, and one patient with stable disease. It is a very, very good situation to be in. 1910 so far is a little bit earlier. Out of 12 available patients, six patients with stable disease. On the 1206 non-Hodgkin lymphoma side, the subQ formulation, there were two complete responses, three partial responses, three patients with stable disease, nine available patients. Super cool. For the IV formulation, five complete responses, one partial response, six patients with stable disease out of 17 available patients. Also as a doublet, very, very efficacious and very well tolerated, of course. The triplet, which is now most important in this development stream, two available patients, two responders, one complete, one partial.

I think also very promising. I'm really excited to see what we have by mid year. On the 1206 pembrol side, one complete response, one partial response, and a patient with stable disease out of 24 available patients. 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. Of course, now with 1808 and 1206, we reach a time point by mid this year where we're really talking, which means 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 eventually financing. 1910 and 1607 will be a little bit later in this year.

Very nice portfolio delivering on all fronts, basically. Then very briefly at the end, the anti-CD84 on colytic virus, as I said. This runs a little bit on the side. Our main focus is on the programs that I just have discussed. Also here, we have made 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-PDL1 treatments. In a patient with a heavily pretreated leiomyosarcoma, it is a very difficult-to-treat patient cancer indication. We could see that BT-001 was able to modulate the tumor microenvironment and is turning a cold tumor into a hot tumor. I think very, very interesting data indeed as well. That leads then to the financial overview.

Before then at the end, I will conclude with the milestones for this year. Stefan, please go ahead.

Stefan Ericsson
CFO, BioInvent International

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 is SEK 6 million higher in Q4 2024. Sorry. 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. 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 is a decrease of SEK 27 million. The reason for the decrease is that in 2023, we 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 cost 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 cost in BI-1607, BI-1206, and somewhat higher cost in BI-1808 and for production of antibodies for customers. We had a little bit lower cost in BI-1910, and we had slightly higher personnel cost in Q4 2024. From 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. Personnel cost 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 - SEK 429.4 million. Liquid funds and current investments end of December amounted to, in total, SEK 867 million. Based on current plans, we are financed until mid 2026. That cash run could be extended if we get upfronts from new collaborations. Okay.

Martin Welschof
CEO, BioInvent International

Thank you, Stefan. I assume you are done. The only thing outstanding before we have our Q&A is the key catalyst for 2025. I think mostly I mentioned that already, but it's always good to summarize it again. As I mentioned, we're really looking forward to the update mid this year because then we'll see further BI-1808 single agent phase II data. Based on the response that we have seen so far, we are quite hopeful. We have two updates on BI-1206, one in non-Hodgkin lymphoma and the triplet, where we have seen so far two out of two. Also here, we hope for a very high and interesting response rate. We will see an update on BI-1206 in solid tumors in combination with pembrol. That will be by mid this year.

During the second half of this year, we have further 1808 data. In this case, it will be a combination with pembrolizumab. Then 1910, we would see single agent phase II-A data and hopefully solid tumor pembrolizumab combo phase I data. Last but not least, by the end of the year, most likely the first triplet data for 1607 in combination with pembrolizumab and ipilimumab. I will stop here, and we will be ready for Q&A.

Operator

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 Richard Ramanius from Redeye. Please go ahead.

Richard Ramanius
Equity Analyst, Redeye

Good afternoon. I'll keep it short. I just have two questions about the. Start with BI-1206, the combination with the subcutaneous rituximab version. What's the status of that, and what's the status of the AstraZeneca collaboration?

Martin Welschof
CEO, BioInvent International

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

Richard Ramanius
Equity Analyst, Redeye

In combination with rituximab in lymphoma, yes.

Martin Welschof
CEO, BioInvent International

Yeah, yeah, yeah, exactly. Maybe I wasn't clear enough. Of course, our focus now is on the triplet, right? That's the main focus that we're running. 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?

Andres McAllister
Chief Medical Officer, BioInvent International

Yeah. 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. Now that we have the BTK inhibitor, the study has been recruiting. As Martin said, we have a very nice trajectory in terms of responses and what we were already seeing in the patients that we're recruiting. I hope that answered the question.

Martin Welschof
CEO, BioInvent International

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

Richard Ramanius
Equity Analyst, Redeye

Yes.

Martin Welschof
CEO, BioInvent International

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

Andres McAllister
Chief Medical Officer, BioInvent International

Yes, yes. 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. The pharmacokinetics and pharmacodynamics are very similar. That's very encouraging because it tells us that in an Eastern population, the antibody behaves very much like it does in Western ethnicities. That's important. They will now move forward with the subcutaneous formulation. We're basically very much aligned in what we're trying to achieve.

Martin Welschof
CEO, BioInvent International

Thank you, Andres.

Richard Ramanius
Equity Analyst, Redeye

Okay, that's all from me. Thank you.

Operator

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

Martin Welschof
CEO, BioInvent International

Okay, thank you very much. Not much remains to be said. I think I have covered probably everything. What I could say is that looking here at the milestone slides, we have a really, really rich portfolio. I think this is something really outstanding for BioInvent. As I said earlier, when we were looking at the slides with the different responses, I think also all the programs are performing super strong and super nice. I think this year will be just a continuation of the second half of last year where we were quite active. As both have said, myself as well as Andres, for 1808 and 1206 mid this year should be really very, very interesting. We expect additional responses.

During the second half, even the programs that are not that advanced, 1910 as well as 1607, should be also quite interesting. From my perspective, and I think I speak for the whole management, even the whole company, we are all very, very excited and very happy with the progress that we had so far. 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 or mega with the progress that we have. They, of course, see a lot of different companies here in Europe as well as in the U.S. In summary, I think we're in a very good position for a very exciting year. Thank you very much.

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