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

Welcome to the BioInvent Q3 2024 Report. [Operator Instructions] Now I will hand the conference over to the speakers, CEO, Martin Welschof; and CFO, Stefan Ericsson. Please go ahead.

Welcome, everybody, to our interim report. And today, myself, the CEO, Martin Welschof, as well as Stefan, will give you the status where the company is and hopefully get across the very compelling status that the company at the moment has. And I will jump right into the situation. So on this slide, we summarize the activities that we had. And I will start immediately with the news, as you probably also have seen from the report this morning. So we have additional positive data for our lead compound, 1206, targeting FcgammaRIIB, especially for the subcutaneous formulation. And I will get back to more details there later. And this, I think, is a very nice example for our progress. So we had good data that we presented at EHA, where we saw 4 responders out of 4 patients. And now we have additional complete responses and partial responses and stable disease, which is actually very good. And that was actually also the reason why we immediately pushed ahead with our subcu in our triplet combination. But I will come back to that later. And then the events that we had, so it was a very busy third quarter. So we had additional positive efficacy data with our single-agent arm of BI-1808, which is our lead compound targeting TNF receptor 2. And that was from the Phase IIa program, and where we had a CTCL cohort, which is a very rare T-cell lymphoma, where we saw 3 partial responses and 1 stable disease out of 4 evaluable patients, heavily pretreated. And we feel this is something very interesting and exciting because it also gives us a couple of strategic options, which we might discuss later in our Q&A. Then we started our subcu triplet combination for BI-1206, our lead program targeting FcgammaRIIB, in combination with rituximab and acalabrutinib. So that has kicked off. And as I said already earlier, so we started right away with the subcu. So our plan was actually to start with the intravenous formulation because, at the time, when we decided to do the triplet, subcu wasn't ready. And we were quicker than we were planning originally, and that's why this is now with the subcu formulation. Then we have received a Notice of Allowance for BI-1910, our second anti-TNF receptor 2 program. And then also, we established a new clinical trial collaboration supply agreement with Merck, MSD, in order to evaluate BI-1607, our second anti-FcgammaRIIB antibody, in combination with KEYTRUDA as well as with ipilimumab. And I think this is also very interesting combi, and I'll come back to that later also in more in detail. Then we presented actually 2 programs at ESMO. We gave a status update for BI-1910, and I'll come back to that later. And then we also gave the status and could show a promising antitumor activity in the ongoing Phase I/IIa trial with BT-001, which is our proprietary anti-CTLA-4 antibody in the oncolytic virus vector from, in combination with the oncolytic virus vector from Transgene. So there, we could really, in patients with solid tumors, show interesting antitumor activity, actually quite promising, that had failed previous treatments. So on this slide, I will not dwell too much. It's just to remind you that we always had a portfolio strategy. So we have the F.I.R.S.T platform, as you know, that has generated a number of programs. And we are currently focusing on 3 targets that you can see on the left-hand side of the slide. So TNF receptor 2, where we probably have the most compelling and complete package at the moment. And TNF receptor 2 is actually a potentially new checkpoint. So this is very, very interesting. And I'll come back to the 2 different compounds that we have in a minute. So this is 1808 and 1910. Then FcgammaRIIB, which is another interesting target in the tumor microenvironment. And there, we have 2 programs: 1206, that we are currently developing in Hodgkin lymphoma as well as in solid tumors; and then 1607 that I just mentioned, we are now going to develop in combination with pembrolizumab and ipilimumab. And then last but not least, CTLA-4. This is our proprietary antibody that we do on a 50-50 joint venture with Transgene, where we combine this antibody with the oncolytic virus platform from Transgene, where we also just had compelling data. Moving then into more details into the anti-TNF receptor 2 program. So 2 compounds. And just to remind everybody, so those 2 compounds were selected from several hundreds very diligently. And those were the 2 that were very interesting preclinically that could really cure cancer in animals. And they have 2 distinct mode of actions. And 1808 is the lead, and that has already shown quite interesting data that we presented at ASCO and then also around ESMO. So in the single-agent arm, and I think I have to remind everybody, so those are obviously patients that are heavily, heavily pretreated. Sometimes they have even 12 rounds of treatment with the standard of care. We have seen single-agent activity, which is very rare. Normally, you would only see that in combination. And 1808 is actually very strong and has a very good activity. So we saw 3 partial responses, 1 patient with stable disease in the CTCL patient population, that I said, out of 4. And then, of course, in addition, we had those other responders in ovarian cancer, in GIST, and also in lung cancer, which I think is very compelling. To basically give you a quick overview of what we're doing because we have a broad development program around 1808. So what I just mentioned was the single-agent activity. So there we have finished the dose escalation, which is the part A, and now in Phase IIa for ovarian cancer melanoma then all tumor types, which is mainly GIST and lung cancer, and then CTCL that I just mentioned on the previous slide. In parallel, we run the combination with pembrolizumab because we have seen preclinically that this antibody is not only interesting as a single agent, but also seems to have synergies with pembrolizumab in combination. And there we have finished now the dose escalation and are now also moving into the -- or have moved into the dose expansion cohorts as for the single-agent compound. And then what is new here is that we also will start, at some time point, the combo with pembrolizumab and paclitaxel because, especially for ovarian cancer, which is a very hard nut to crack, this could be very, very interesting for patients. And then we will have other tumor types that we did not announce yet. So I think this will be a very interesting program. And I'll come back later when we expect the further data on 1808. But I can mention already that we will have an update on the single agent by the end of the year. Then the second candidate that we have, 1910. There, we had a trial in progress poster at ESMO, and where there we could show a robust target occupancy. And we did further exploration of the dose safety and tolerability, and this trial is going very, very well. And we will then -- once we have finished the single-agent dose escalation, go into several tumor types, including HCC. And the next step here, actually, or the next milestone for this program is see the first Phase I single-agent data by the end of the year. So by the end of the year, just to summarize it only a little bit. We have 1808, further additional single-agent data, as well as for 1910, the F.I.R.S.T. Then moving into our anti-FcgammaRIIB platform. There, we have also 2 candidates: 1206, which is our lead that we developed in a triplet for non-Hodgkin lymphoma, and then in combination with pembrolizumab for solid tumors; and then the second candidate is 1607. So starting with 1206 first. So there, we had, and I mentioned it on my first slide, very impressive clinical data, additional 1 for the subcu. So we had 1 additional complete response, 1 additional partial response and then 2 more patients in stable disease, basically continuing the trend that we have seen at EHA. So now, altogether, we have 2 complete responses, 3 partial responses and 3 stable diseases out of 9 evaluable patients. So this is super, super compelling, and that's why we have started the triplet, which is shown here on this slide with the subcu. And as I said, the original plan was to do it with the intravenous formulation. But since we have this very strong development and also quick development for the subcu, we decided to take the subcu instead. And this is, of course, much more favorable also from a product perspective because it's a difference of a couple of minutes subcu compared to 1, 2 more hours IV application. So I think this also has direct product consequences. The triplet is running. I think it's a very competitive positioning because we expect to see a very strong overall response rate. What you would see also for, for instance, CAR-T as well as bispecifics, but a much, much better safety profile. So when you think about the U.S., for instance, the largest market for those kind of products, the majority of cancer patients is treated at the community hospitals, at the local hospitals. And they are overwhelmed dealing with toxicity, which is related to CAR-T or to some bispecifics. So for the majority, this would be the dream product because then you don't have to be wondering and you get the same -- probably the same efficacy. We'll see the first preliminary dataset by the end of the year. And that, of course, will be hopefully telling. And that is, of course, also important for this program. So very, very excited about it, and it's running well. Then coming to 1206 in solid tumors. And the triplet, maybe just to mention it, just going back, so this runs in collaboration with AstraZeneca. So they provide, under a supply and collaboration agreement, the compound acalabrutinib. And then on the solid cancer side, we have the same thing in place for Merck, which I think is also a very interesting dynamic. The solid cancer combination also looks very interesting. So currently, we have 24 available patients, where we saw 1 complete response, 1 partial response, 7 patients with stable disease. Obviously, also very heavily pretreated patients that do not respond anymore to this type of therapy. And the next step here will be then when we disclose further Phase I data of this trial by mid next year. But I'll come back at the end to a summary of the milestones next year, which will be plenty. Then 1607, so this is actually quite interesting. 1607 is the second candidate targeting FcgammaRIIB, and we have basically characterized this already in combination with trastuzumab preclinically. We had 2 validation: one in combination with trastuzumab; the other one in the triple combination with pembrolizumab and ipilimumab. And the trastuzumab combination, we presented that data from the dose escalation at the San Antonio Breast Cancer Symposium in December 2023. We could show it was safe. We saw actually quite a number of disease stabilization. So that was very interesting. But the main reason why we did this is what we wanted to show that our compound is safe before we then do the triple combination, which we see as more interesting because that was always the Holy Grail of a lot of treating oncologists. To combine pembrolizumab with ipilimumab, so far, is very complicated because of the toxicity profile of ipilimumab. And basically, you can call what we're trying to do is enabling this combination with the -- with our antibody, 1607. So we will soon start patient recruitment for this triplet Phase Ib/2a study, with the first dataset actually coming in during the second half of next year. So also a very interesting program. Then last but not least, the anti-CTLA-4. So this is a proprietary anti-CTLA-4 antibody that we have discovered with F.I.R.S.T, and that has been put together into the oncolytic platform of Transgene. And we have presented now data at ESMO in combination with pembrolizumab. We could show that we can induce tumor regression in patients who failed previous anti-PD-L1 treatment. And 1 patient, actually, with a heavily pretreated leiomyosarcoma, was able to modulate the tumor microenvironment, turning a cold tumor into a hot tumor, which I think is very interesting. So we have early signs, basically, of efficacy with clinical responses observed with the BT-001 in combination with KEYTRUDA in 2 out of 6 patients. And this study is not fully complete. So there will be further data collection during the end of this year. So I think now I'm going to hand over to Stefan for the financial part.

Thank you. I will present the financial overview for Q3 and the 9-month period, January to September. All amounts are in SEK million, unless otherwise mentioned. Net sales were SEK 12.8 million in Q3 2024 compared to SEK 26.8 million in Q3 2023. That's SEK 14 million lower in Q3 2024. That decrease is related to that we had a $1 million milestone from Exelixis in Q3 2023. Research funding was SEK 8 million higher in Q3 2023. But however, production of antibodies for customers was SEK 5 million higher in Q3 2024. Net sales for January to September 2024 were SEK 23.3 million. For the same period in 2023, the sales were at SEK 56.1 million. That's a decrease of SEK 33 million. That decrease is related to the $1 million milestone that I just mentioned. Research funding was SEK 26 million lower in 2024, but production of antibodies for customers was SEK 4 million higher in 2024. Operating costs increased from SEK 108 million in Q3 2023 to SEK 120 million in Q3 2024. That's an increase of SEK 12 million. We had higher costs in BI-1607 and BI-1808 and somewhat higher cost of BI-1910. We had lower cost in BI-1206. And we had somewhat higher personnel costs in Q3 of 2024. For January to September, the increase of operating cost was SEK 53 million, from SEK 315 million in 2023 to SEK 368 million in 2024. We had quite higher cost in BI-1808, BI-1607 and BI-1910, with somewhat lower cost for BT-001. And personnel costs in 2024 were quite higher compared to 2023. The loss for Q3 2024 was minus SEK 97.2 million, and we had loss from January to September 2024 of minus SEK 312.5 million. Liquid funds, current and long-term investments end of September amounted to, in total, SEK 979 million. Over to you, Martin.

Thank you, Stefan. So then I will close the presentation with this slide. As I mentioned already during my presentation, I will summarize the -- not the events, the milestone, the remaining milestones for this year, and then also give an outlook for next year. So as already mentioned, so we are still expecting updates this year for our 2 anti-TNF receptor 2 antibody and antibody, so 1808 as well as 1910. And as you can see, so we call this our TNF receptor 2 antibody. This is a very compelling dataset compared to what is out there from the competition. And for 1808, we'll have additional single-agent Phase II data by the end of the year. And then for 1910, the first single-agent Phase I data. Then also, for our second lead program, which is BI-1206, targeting FcgammaRIIB, we'll have the first patient -- preliminary patient data by the end of the year. So this is the combination that I mentioned with rituximab and acalabrutinib. The next year, so obviously, the couple of last months have been very busy for BioInvent. So we are now moving actually into what a quite interesting phase. Next year will be more busy. You can imagine, based on this rich portfolio that we have, that should drive quite significant value. So we'll have, during the first half, further single-agent data for BI-1808, and then further data for the triplet, 1206 in combination with rituximab and acalabrutinib. And then, as I mentioned also, for 1206, and that will be also then already the subcu data in solid tumors in combination with pembro. So that will be during the first half. And there will be -- we would typically target ASCO as well as AHA. So that's at least what we have in mind. And then for the second half, there will be 1808 pembro combo data, the Phase IIa data, further 1910 solid tumor single-agent data, and then potentially, also, the first 1910 solid tumor pembro combo data. So I think that would be also quite interesting. And there, we try, of course, to target conferences such as SITC. And then also, second half of next year, then the 1607. The combination enabling the combined therapy of pembrolizumab as well as ipilimumab, 1607, that will be also during the second half of next year. So I think I will end my -- or our presentation here and then open up for Q&A.

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

I have a few questions. Starting with the AstraZeneca acalabrutinib. Do you have a comment on interest from AstraZeneca? And it seems this trial is going quicker than the other BI-1206. Are they involved? Or is it just you pushing this program?

So obviously, there's interest from AstraZeneca, maybe to start with that one first. I think I don't know whether we are the only one, but we are one of very rare supply and collaboration agreements that they do. And basically, when we approached them with this idea because we had some data and then mainly also then ideas, they liked it very much. So there's definitely interest. And I think it's worthwhile to mention. So we are targeting, in the triplet study that we are running, follicular lymphoma. We'll also include others, other non-Hodgkin lymphomas. But AstraZeneca is quite interested in follicular lymphoma because they have only approval for mantle cell lymphoma. So I think that is quite interesting. And of course, at the end, it will be data-driven. But I would say, if we see a good response and good safety, that's what we expect, there will be definitely interest from AstraZeneca. And I wouldn't say that this is running much quicker. I think also, our other studies, because you have to see, the 1808 is actually quite a broad program. And I think it also -- has expanded quite quickly. I would say that -- and there's no specific push for one or the other. We all try to do all of them as quickly as we can, yes?

Okay. And how about the new BI-1206 SC data? To me, they are a bit better than the IV you presented. Do you agree? And do you think that might lead to better receptor occupancy?

Yes. So we're currently characterizing it. So absolutely, I agree. So we -- it seems that we have more activity. And of course, the subcu, as I can also mention, has approved safety profile. The IV was also safe. But remember -- so there's quite some background noise. Remember that we had some infusion-related reaction, which, clinically, didn't do any harm, basically comparable to what you would see with rituximab. But with the subcu, this is completely gone. That was also one of the reasons why we developed subcu. The second reason was we want to have something more user-friendly. And then -- and this was kind of surprising. We didn't necessarily expect that it looks also -- this is more active, and we are analyzing it, absolutely. But we can't tell yet exactly where this is coming from. It's just an observation for the time being, and we are analyzing it.

Yes. Yes, sure. Next up, I wanted to ask about trastuzumab. Are you planning any combination trials with BI -- with 1607?

Yes. So with 1607, as I tried to explain during my presentation, so the -- so we have -- preclinically, we have the validation for both, the combination with trastuzumab as well as the triplet. We think, from a patient perspective as well as from a commercial perspective, the triplet combination is probably most interesting. That's why we are favoring it. And the reason why we started with trastuzumab is really to see what the antibody does and also to establish safety. Because in the triplet combination, it will be more complicated. So now we know 1607 is completely safe because we didn't have any toxicity issues, which, of course, is very important once we go on the triplet combination. So for the time being, we are focusing on the triplet combination.

Yes. Okay. I read some interesting news about your strategic -- or your other out-licensed programs, for example, HMI-115. Do you have any comments on those programs? Since they seem to be, in this case, they're Phase III-ready, and the endometriosis results look really interesting.

Absolutely, you're right. So I think all this -- we have roughly 5 or 6 programs with companies such as Takeda, Mitsubishi, Daiichi, et cetera. And now we have 2 programs that seem to be -- and this is something that is in the public domain, but it has not started yet, that are Phase III-ready, which is one program from Takeda and the other one from Bayer/Hope. And then the others, probably then moving -- I'm not looking at the slide at the moment, so I just have to remember, try to remember. So it's moving probably soon from Phase I to Phase II. But at least there are 2 programs, which are basically Phase III-ready. And this is, of course, super interesting, absolutely.

Final question about your cash position. Quite soon, you'll have -- you used to have a really good runway, and soon you'll be approaching a 1-year runway. Are you planning on reducing that in any way? Or how would you -- what's your ideas on keeping a good cash position?

Yes. Well, there are various possibilities. But -- so we are -- we currently have a runway until the end of Q1 2026, which I think is very good. Most of biotech companies don't have that nowadays. And obviously, now we're moving into a phase where it's not only interesting for investors, but also for corporates. And that will be also one ambition of the management team to get based on -- and this is, of course, completely data-dependent. But I think if we developed the data, as we're doing it at the moment, the same trajectory, then I think we should have a good chance to also do collaborations with corporates that could generate significant cash, absolutely.

How important do you think the CTCL data will be in -- with BI-1808in the short term for a potential deal?

Yes. So CTCL is interesting for various reasons. So first of all, this is a smaller indication. So we're currently looking into that in order to explore strategic clinical development possibilities because then you could probably run a pivotal Phase II trial, a smaller one, at some time point, and we're currently working on that. And we'll, of course, then, once we have updates to the market, could provide those updates. And what we can say is that, the current treatment, so what we see is a response rate, but this is still early days, right? It's just some patients, but hopefully, by some time point, either end of this year or early next year, we'll see more patients. This but currently looks actually a stronger response rate than what is currently the standard of care, which is super interesting. At the same time point, it's also safe because the standard of care, which is out there at the moment, is not safe. It's super toxic. So I think this could be something very interesting. But again, so what we see at the moment is early. And it could provide, indeed, also a potential strategic partnering opportunity since, in case we continue to see the data that we currently see, this is an orphan indication. And if you get orphan designation, there's potentially fast track, et cetera, et cetera. So I think this is very, very interesting, absolutely.

The next question comes from Dan Akschuti from Pareto Securities.

One would be a bit in terms of what kind of patients you're enrolling for BI-1910 in HCC. Do you find patients there that are not treated with checkpoint inhibitors?

Yes. So currently, of course, during the dose escalation, we try to have focus on that patient, but this is more for the dose expansion cohort. So currently, it's all-comers that we are enrolling. And of course, we try to focus on this specific patient population for specific reasons, which I don't want to discuss here. You know the competitive landscape. And that's also why we didn't disclose yet what we will do besides HCC. So currently, it's all-comers, with then focus on that patient population.

Okay. And can you share with us if there are some patients in that group that are checkpoint-naive?

There will be an update by the end of the year, Dan. But I can tell you, just to give this a little bit of flavor. So the update that we will have by the end of the year will not be -- not only be safety.

Okay. And how do you see that difference in subcu effect? At least now we know it in NHL. We don't know yet in solid tumors. But considering that it's pretty similar molecular lymphoma patients, what are you concluding? From my perspective, this is kind of additional confirmation when we see kind of the same drugs combined, but we see stronger effect with the subcu version, which makes logical sense. But do you see that as well? Or do you think that it's not something we could conclude from this?

Yes. So what I can tell is that the subcu is also very nicely behaving in the solid cancer, and we will soon switch to subcu there only. So we see the same, what shall I say, better or stronger, or yes, call it just better activity in the solid as well as in the non-Hodgkin lymphoma. So it's not only there. So the non-Hodgkin lymphoma is just a little bit further advanced because, there, we started it, and then we enrolled it into the solid cancer. But also, in the solid cancer, development looks very promising. And you could see there was one slide, when we move into those expansions, so there will be only subcu.

Okay. And then maybe a follow-up on that. Can you share a bit on the patient distribution of 1206 subcu solid tumors?

Not yet. So basically, it's -- what we do is they're the same, what you already have seen. So melanoma, uveal melanoma, sarcoma. So it's a mix of patients. So there's not a big difference compared to the IV. And then when we move forward into dose expansion, which will be, of course, then only was a subcu, I think the focus was on lung cancer. And that, of course, are also patients that we're currently having in the dose escalation.

The next question comes from Sebastiaan van der Schoot from Van Lanschot Kempen.

Congrats on the progress. Just a few questions from my side. On 1206, I think you just mentioned that you would like to see good efficacy for the triplet combination. You currently have around 50% for the combination with rituximab for both the subcu and IV. Is there any data available for rituximab plus BTK inhibitors in non-Hodgkin's lymphoma? Just to get a sense of what would be a good benchmark.

Yes. So basically, so I don't have, out of my mind, all the benchmarks. But what we are expecting is, overall, a response rate around 80%.

Around 80%. Okay. And then on 1808, could you maybe provide some insight on what type of data we are going to get by year-end 2024? How many new patients can we expect for each different indication cohorts? And what metrics will you provide in the data?

Yes. So basically will be further safety and efficacy data safety. We basically expect to keep the good safety that we have. So we don't expect anything else at the moment, at least. And then, of course, there will be further data, further CTCL data. We have recruited further these patients or further this data, and then the other cohorts that we have included. And we are not giving any forecast there because we can't. It's difficult to predict. Of course, we have recruitment rates, et cetera, et cetera, but it's always difficult to predict. But it will be those -- out of those expansion cohorts that you have seen on this one slide, what we presented to you by design.

Okay. So then I can assume like a handful of patients for each cohort.

Yes.

Okay. And then what's interesting, you just mentioned the partnered assets that are Phase III-ready. Could you provide some color on what the economics are on those partnered assets?

Yes. So this, we never disclose. So you will learn when we release it to the market because the agreement that we have, for instance, with Mitsubishi and others, is that we don't disclose the milestones, or the economics were not disclosed. But those are standard deals. There was an upfront. We have preclinical and clinical development milestones. And then later, there will be commercial milestones and royalties. And what we do is, as soon a milestone is triggered, then we have a press release to the market.

Do you expect milestones with the start of the Phase III study?

Yes. So you will learn when we disclose. But this is, of course, a very important step for the clinical development program of a product. So -- and of course, for us, it's a super strong validation because -- that you put something into Phase I, maybe into Phase II, but then it's a big step to go into Phase III. So this is, of course, a very important milestone for -- not only for, in this case, Takeda and Hope/Bayer, but also for BioInvent. Because it shows that our antibodies have those capabilities, that we can move them all the way through and then turn them into -- hopefully, into successful products.

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

Yes. Thank you very much. So that will be then closing comments because we are already quite over time. So I will end with the milestones for next year again. So as I mentioned, very busy a couple of last months. So I think we have shown that we moved our portfolio successfully, not only into Phase I, but more also into Phase II, at least, for the 2 lead programs, 1808 and 1206. And that, of course, sets the company up for a very interesting 2025 because then we have further Phase II data for 1808 as well as 1206. And then also 1910 will come along nicely. So I think also, there, we are quite excited since we have probably the most compelling and complete TNF receptor 2 platform compared to our competitors. So yes, as a closing remark here, so next year will be super, super exciting and will set up -- set the company up for strong value generation. Thank you very much.

The host has ended this call. Goodbye.