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

Yes. Welcome, everybody, to our year-end report, and we will guide you through a number of slides. First, I will give you a summary of what has happened, with some focus areas. And then at the end, Stefan Ericsson, the CFO, will give you the financials and I am the CEO, Martin Welschof. So I will start on Slide #3, where we have a summary of the main events in the fourth quarter. And I would like to start with our program BI-1808, which is our lead program targeting TNF receptor 2. And we had very interesting positive data from the clinical Phase I/IIa, which is currently ongoing, where we test the antibody [ DRH08 ] as a single agent, and we presented that at SITC, and I will come back to the data a little bit later. Then we also have shown preclinical data providing clear evidence of the potential of our second anti-TNF receptor 2 antibody BI-1910, and that was any -- also presented at SITC. And I also wanted to make the point already here. So we are the only company because by now, there's actually quite some competition around TNF receptor 2, we're the only company that has both a blocking leading antibody, which is BI-1808, and an agonistic antibody, which is BI-1910. Then we also presented positive clinical data on our second anti-FcyRIIB program, which is the antibody BI-1607, and that was presented in December last year at the San Antonio Breast Cancer Symposium. We also have enrolled our first patient in our Phase I/IIa clinical trial for 1910, our second TNF receptor 2 program. And then we also announced, together with Transgene, who is our partner that we have the first patient treatment in the Part B of our ongoing Phase I trial, assessing the novel oncolytic virus BT-001 in combination with KEYTRUDA. Then we had two events after the end of the period. We signed just recently a supply agreement with AstraZeneca to evaluate our lead anti-FcyRIIB antibody BI-1206 in combination with Acalabrutinib, which is the product of AstraZeneca. And of course, it's a triplet in combination with Rituximab. And I think this is a very cool thing because it really positions 1206 very, very nicely and very competitively in the Non-Hodgkins lymphoma landscape. Then we also regained the rights to immuno-oncology targets from our Exelixis collaboration and maybe we can discuss it later a little bit more in detail in our discussion at the end of the presentation. I just want to quickly remind you that we are a company that is not a one-trick pony, but rather the opposite. So we have a very strong proprietary clinical pipeline with multiple value drivers. And as you can see on this portfolio slide, focusing mainly in two areas: TNF-receptor 2, where we currently have three clinical programs running, 1808, which is our lead program there as a single agent and in combination. And then we will do the same with 1910, that just has started recently, our second anti-TNF receptor 2 antibody. The other target that we're focusing on is FcyRIIB. And there, we also have two programs, 1206, which is currently running in two trials, one in Non-Hodgkins lymphoma, the other one in solid tumors and then more recently, 1607 focusing on solid tumors only. And then last but not least, we have our collaboration with Transgene focusing on CTLA-4, a very interesting target where we combine our proprietary, unique anti-CTLA-4 antibody with the oncolytic virus system of Transgene, and that is currently running in combination with pembrolizumab. So wherever you see pembrolizumab in the portfolio, we have a supply and collaboration with Merck and then the other partner that we also have since some time is CASIPharmaceuticals, they have the exclusive rights for 1206 in China. In the following slides, I will go through the various programs, and I would like to start actually with 1808. Again, our lead entity and TNF receptor 2 program, where we saw positive single-agent Phase I data in November last year. And we currently have 21 evaluable patients out of those 21. We have 7 patients with stable disease. And then we have one very robust partial response so far, and that has been observed in a patient with GIST and that we presented at SITC in November 2023. And that patient is very interesting, and we're quite excited about it and still are. This was a patient that was heavily pretreated. So this patient received 12 treatments before and is now on single-agent 1808. And on the right-hand side, you can see the nice response. So you can see that after some -- after the first data point, we initially thought it's progressive disease, but then all the lesions declined drastically by 60%, some disappeared completely. And this is a typical profile that you would see for a new modulatory compound, which 1808 is. So very, very interesting. And obviously, the stable disease patients that we have might go into a similar response. We don't know, but that -- it's still it's a possibility. But besides this very early and first strong partial response. We have excellent safety, no ILTs, and the maximum dose was not reached, although we know that we have 100% receptor occupancy and below the slide on the right-hand side, you see a little bit more detail around the patients of 50 years old/55 years old. And as I said, with multiple metastatic lesions and despite 12 prior lines of treatment, and the patient is still on treatment, which is actually quite interesting. So the next step then will be the initial Phase IIa single age data by year end of 2024. And maybe I should remind you that we have started now multiple dose expansion cohorts in various areas, such as ovarian cancer, lung cancer, melanoma, CTCL. And our focus is really to show single-agent activity because that will be a very, very strong value driver for that program. And in parallel, of course, we run the combination with pembrolizumab. So on the next slide, we have the initial preclinical data for 1910, which is also a potential best-in-class antibody -- and as I said already at the beginning, so we are the only group at the moment that has both a blocking the leading type of antibody targeting TNF receptor 2 as well as an agonistic antibody targeting also TNF receptor 2, which is BI 1910. And we have started BI-1910 a while ago, and the first part will also evaluate BR-1910 as a single agent. And the second part will be also in combination with pembrolizumab and the exploratory expansion cohorts that are then planned hepatocellular carcinoma as well as non-small cell lung cancer. The preclinic data, as you can see on the right-hand side is quite strong, and we expect the initial Phase I single agent data by the end of this year. So I think with these two different programs, we really kind of occupy the target, TNF receptor 2. Obviously, we have also quite some IP around it, and we are well advanced compared to the competing programs that are following us. Then switching to FcγRIIB. Our other targets that we are focusing on besides TNF receptor 2. And as I mentioned initially, so we have the agreement with AstraZeneca now in place, and we will combine going forward, 1206 with Rituximab and Acalabrutinib. And AstraZeneca provides the BTK inhibitor for the combination as already mentioned, and we will focus on treatment of patients with follicular lymphoma who have progressed or are refractory to rituximab. And this is actually quite interesting because the AstraZeneca compound is currently not approved for that indication, and we might be able to give them that approval. We will do this as a part of the IV dose expansion, and we expect to enroll approximately 30 patients in Sweden, Spain, U.S. and Brazil. The next steps for 1206 is the subcu data. So I'll just remind you that we continue to develop the subcu, and the Phase I data should be available first half of 2024, and then the initial Phase II [indiscernible] data by the end of this year. So also this remains very, very exciting. Then switching to 1206 and pembro. They are basically -- what is next is that we will present further 1206 plus pembrolizumab Phase I data by the middle of this year. Just to remind you, we have a number of patients now enrolled. And the inclusion criteria is that they have at least one prior line of anti-PD-1 and anti-PD-L1. A lot of the patients that we see have at least two -- some even have three. And currently, we have 18 evaluable patients. We have no major safety concerns. And we see two long-lasting past responses with patients that didn't respond anymore to anti-PD-1 and PD-L1 therapy. -- and two patients with stable disease. And I should mention that those data that we have generated is in the IBM, we are also developing this with the subcu version of 1206 as well. So as I said, so further data will be available by mid this year. Then switching to our second FcγRIIB antibody, which is 1607, and we presented the first data set in December at the San Antonio Breast Cancer Symposium. Summary is the treatment was very well tolerated, no serious adverse events. We had 18 patients and doses ranging from 75 milligrams up to 900 milligrams flat dose. The best clinical response that we have seen so far is stable disease and that we saw in 6 patients -- or see in 6 patients out of 11 evaluable patients. So actually already a nice sign of early efficacy. And we see the predicted PK profile adequate exposure and full receptor occupancy. The next step here will be that we are currently determining -- and that is ongoing, and we will inform the market soon -- to choose the most optimal combination regimen for 1607 in the continued development of 1607, our second anti-FcγRIIB program. Then coming to BT-001. This is our 50-50 joint venture with Transgene. And just to remind you, so we have proprietary, very unique competitive anti-CTLA-4 antibody, which is proprietary to us, and we have combined it with the oncolytic virus system of Transgene. And we have done the first part of the study, where we used it as a single-agent, and there we observed objective antitumor activity. That means decrease of injected lesion size of more than 50% that were observed in two patients. And we completed the -- all the Phase I cohorts in the monotherapy with no safety concerns, and we have stabilization of injected lesions in 11 out of 18 patients -- and we have started in October 2023. The second part, which is basically Part B, evaluating the combination of BT-001 and in combination with pembrolizumab. And the next step there will be basically the Phase I Part B data, and that will be available second half 2024. That leads me to the financial overview. Stefan, over to you.

Thank you, Martin. I will present the financial overview for Q4 and the 12-month period, January to December. All amounts are in are SEK million unless otherwise mentioned. Net sales were $15.3 million in Q4 2023 compared to SEK 20.6 million in Q4 2022. That's $5 million lower in Q4 of 2023. The decrease is related to the production of antibodies for customers was SEK 4 million lower in Q4 2023 and research funding was approximately $1 million lower in Q4 2023. Net sales for January to December 2023 were $71.5 million; for the same period in 2022 net sales were $326.1 million. That's a decrease of $255 million. The decrease is related to that we -- in 2022, we received an upfront payment of $25 million, corresponding to SEK 256 million when we signed an agreement with Exelixis. In 2022, we also received EUR 0.5 million milestone from Bayer. The decrease is also related to that revenue from production of antibodies for customers was$25 million lower in 2023. Positive deviations from 2023 were that research funding was $20 million higher and that we, in 2023, received a $1 million milestone from Exelixis. Over to operating costs. Operating costs increased from $99.9 million in Q4 2022 to $126.2 million in Q4 2023. That's an increase of $26 million. We had quite higher cost in BI-1206, BI-1808 and BI-1910, and somewhat higher costs in BI-1607. We had solid lower cost for production of antibodies for customers, and we had higher personnel costs in Q4 2023. For January to December, the increase of operating cost was $64 million from $377 million in 2022 to $441 million in 2023. We had quite higher costs in BI-1206, BI-1808 and BI-1910, and we had quite lower cost for production of antibodies for customers. Our personnel costs in 2023 were quite higher compared to 2022. The loss for Q4 2023 was minus-$97.2 million, and we had a loss for January to December 2023 of $330.3 million. The share issue completed in January 2023 amounted to $31.3 million before issue expenses. And liquid funds, current and long-term investments end of December 2023 amounted to a total of $1.283 billion. That was summary.

Thank you, Stefan. Then I just switch, I think, to probably the last slide, which is summarizing the milestones that I already mentioned when I talked about the various programs that I can summarize here again. So as I said, so we're super excited about BI-1808 as a single agent for a number of solid cancers. That is our lead program targeting TNF-receptor 2. And the early Phase II data should be by the end of the year 2024. So that will then evaluate 1808 in a number of different single-agent cohorts. I mentioned already, ovarian cancer, lung cancer, melanoma, CTCL and then probably also some other solid cancers. And that will be a very interesting mix, and I'm really looking forward to that data package. Then as I mentioned, 1206, we are focusing now -- besides, obviously, also the development of the subcu on the intravenous that we're combining with Rituximab and Acalabrutinib under the supply and collaboration agreement with AstraZeneca. And that first initial data points should be available by the end of the year. So that's actually quite interesting. Then switching to the other side. Obviously, mid this year, we'll get 1808 plus pembro. Even though we are now really committed and focused to show the single-agent activity of 1808, it's still important also due to the combination with pembro because at the end, of course, all cancer treatments will be in combinations, but I think it's a super strong value trigger that we can show single-agent activity. And the first data set we are already seeing and we want to consolidate that. Then what is also available by the mid of this year is obviously the 1206/pembro data or some update on the BI-1206 plus pembro, in solid cancer, where we also have already some first interesting responses. And then by the end of this year, second half, BT-001 plus pembro, which is currently running. And then, of course, our second TNF receptor 2 program, which is BI-1910. And also there, we will have first single-agent data. And just to repeat myself, I think we are currently the only company that is really having both flavors because when we look at our competitors, such as BeiGene, [ Semseer ], Innovent they have either the blocking/deleting or the agonistic type. I think that's the end of the presentation. Yes, just to remind maybe the audience that is hearing us for the first time. BioInvent actually a quite integrated company, and that's something that really gives us a strong competitive advantage. So we have a discovery engine that allows us to discover targets and antibodies. We have strong expertise in immunology, cancer biology and antibody biology. And then obviously, we're quite integrated in that sense that we also do our own manufacturing, which gives us the flexibility to test different compounds and also different formulations. So that's the end of my presentation, and I'm happy to take questions.

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

So let's start with the economic ones. Could you give us a cost guidance for 2024, more specifically, could you say how they will differ from Q4 in 2023? And then a related question, seen as a lot of these studies are progressing into Phase IIa, which are quite large studies, which -- with a large number of subjects. Could you discuss which programs you will prioritize?

Yes, I'll start with the forecast. We don't really guidance for operating costs in 2024. What we can say is that we are based on current plans, we foresee to have financing out till the end of Q1 2026. And that, of course, cash run could be extended if we do some out-licensing and get an upfront. Your second question, please, is Phase I in relation to Phase II, you said? Can you repeat that question?

No. Actually, I was -- or my assumption was that costs will increase as projects advance into multi-cohort Phase IIa trials. So will you have -- or is that assumption correct? And how will you prioritize?

I mean we have the financial means to run our projects as planned. So we will run our projects in parallel. So -- but of course, there will be more cost in Phase II.

Okay, thanks. A quick question on BI-1206. How is recruitment going there? Or do you have -- is it needed to recruit patients?

So far -- and of course, then we have to differentiate a little bit. So we have now various arms. So we have the IV in combination with Rituximab. We have the subcu in combination with Rituximab. And now we're preparing for the triplet, which will be 1206, Rituximab and Acalabrutinib. So recruitment actually is good. And I know what you're referring to. Of course, there's quite some competition, but especially with the new addition or the new positioning as a triplet is actually a tremendous interest. So -- that has obviously not started yet, but we assume that we will have a very good recruitment rate, such that we -- by the end of this year, already can present the first data for the triplet. And that is our #1 focus at the moment, for 1206 and Non-Hodgkins lymphoma.

My last question was just that the collaboration with AstraZeneca, since BI-1206 can be used in combination with checkpoint inhibitors. Do you have any plans of testing it with their checkpoint inhibitor Durvalumab to -- seem to -- preclinical studies, for example, to improve the negotiating position, or. . .

Not currently. So currently, the AstraZeneca collaboration is actually focused on Non-Hodgkin lymphoma only, which is then the triple combination that we're currently discussing. But of course, this is probably their first trial. And you would remember that we have now, I think, in number -- I don't know exactly from the top of my head, but 3 or 4 such collaboration with Merck. So obviously, there's nothing blocking us to extend also our collaboration with AstraZeneca. But currently, the focus with AstraZeneca is with Non-Hodgkins lymphoma only.

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

Congratulations on the progress. The first one is regarding the 1808 and pembro combo. It will be very helpful if you can indicate the type of patients that you are targeting in terms of indication and prior immune checkpoint inhibitor exposure? And also provide some color on how many patients and how many follow-up you expect to report on by mid-2024? And whether this will be at a conference? And I also have a follow-up.

Yes. So the patient population is more or less the same as we have done also with the single-agent, which will be all comers in solid cancer. So it will be the same type of mix because we're using also partly the same sites that we're using for the single-agent already. The amount of patients, I don't know exactly from the top of my head, but it will be the total dose escalation part of that study, which should be roughly the same number as you have seen for the single-agent. So it will be the full data set for that. And as I said already initially, so what we're obviously doing and we run both in parallel. As I said, so I think the value driver, as I see it, for 1808, will be the single-agent activity. Obviously, you still have to show also that you can work in synergy. And we saw that preclinically, we saw preclinically strong single-agent activity as well as strong synergies with anti-PD-1. And that's what we seem to see as well as in the clinical programs. And maybe one additional comment here because I think it's interesting. Probably you will remember, Sebastiaan that we -- during the preclinical work, and that is all published. We have done a fair share of characterization regarding potential markers in the animals, and we could actually see certain markets, and I think we didn't publish them, not yet, because we are still putting IP and keep it rather close to us, especially since there's now quite some competition. But what I can tell you, the same signals that we see in the animals, before we see a response in the animals, we also see in the patients. So we saw it in the gist patient and we saw it also in the non-small cell lung cancer patient, which unfortunately is not part of the evaluable patients anymore because we develop a secondary cancer. But we basically, besides the gist, we also had a second patient that also showed a very strong partial response, which was a non-small cell lung cancer patient.

And can you maybe talk about whether the patients in the next update will have prior exposure to immune checkpoint inhibitor because I believe that the gist patient was the only patient that did not have prior exposure to ICI?

Yes. So we have a number of different dose expansion cohorts. So one is ovarian cancer, where we made super progress, very good recruitment rates. All those patients, obviously, are checkpoint naive. And then we will have a melanoma cohort where we can be close to first line. So some of -- so those would be also then checkpoint naive and the other will be probably a mix. But we're trying to get checkpoint-naive patients into the trial and the ovarian cancer cohort is definitely without checkpoint.

Okay. And that would then also be the same for the combination with pembro that you are targeting patients that have not had prior ICI exposure?

So in the protocol, what we have done is that the same expansion cohorts, as I just described for the single-agent, we will use for the combination. But obviously, also to make it very clear to the audience what we're discussing at the moment is single-agent dose expansion cohorts and for the combination with still in dose escalation, but that data set, as you said, will be available by mid this year.

And then the dose. . .

And once we have done that, then we go into the dose extension also for the combination. Absolutely.

Okay. Great. And then regarding the subcutaneous formulation for 1206 I think that the initial guidance was last year for H1 '23, but I think besides a general remark on that 100-milligram dose is safe, we have not seen any clinical data, and I don't see any real time lines mentioned for the subcu. So I'm just wondering what the plan is regarding is regarding the subcu? And also whether you're going to progress this formulation of the IV formulation in, for example, the triplet combination?

Yes. So subcu data will be available, and I think I mentioned it in one of the slides is not mentioned here on the overview on the milestone slides, will be also available by the mid of this year.

And will that also include clinical response data or...

Will be clinical data. So all the patients that we have treated until that time point, it will not be only safety, but also response data. Absolutely.

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

Yes. I'm happy to address one remaining question from Samir Devani. And I'll just read the question to everybody. So: "hi, what level of response is the benchmark you are looking for in the Phase II data from BI-1808 as a single-agent to progress development?" Thanks, Samir. So just a couple of comments, actually. So our aim is not necessarily to develop 1808 as a single-agent at the end because, as I said, so when you look at cancer therapy, even if we have strong reagents such as anti-PD-1 pembrolizumab, at the end, they are all used in combination because that's giving you the best response. So we currently run both. But I think already the level that we have now, so is basically the gist for the time being, also count the lung cancer, even though it was not available, but I think we can just for the time being count it and then we have a number of stable disease. It's already actually quite remarkable because all those patients that we have treated are end-stage patients. Remember, the Gist patient 12 regimens before prior to the treatment of 1808. So I think what we're seeing here is actually something similar when for the first time, KEYTRUDA or pembrolizumab was used as a single-agent in clinical development. And I think we have the potential here for 1808 as well. Of course, it remains to be seen, but that's what we're trying to do. And we focus currently a little bit on the single-agent in order to really make sure that we consolidate that data ,that we confirm that data because it will be a strong value driver. But I believe -- and of course, has to be shown because it's still early in clinical development that at the end, it will be combination in any way. And that's why we do also the combination with pembrolizumab. So then there's another question: "You're currently trading below cash -- how do you intend to finance the company going forward?" So as already Stefan mentioned. So first of all, I think we have a very strong news flow, and I'm sure something like showing or confirming the single-agent activity that we see for -- single-agent activity that we see for 1808, I think, will drive the share price up. In any case, and that's something that we have as follow our strategy in any way, is partnering. And as you can see, we have a quite large portfolio. So we are not shy to do partnering. And I think if we can confirm single-agent activity for 1808, I think we could do a very nice deal with a triple-digit upfront. So -- and that should suffice for a nice capital injection. And then what you could do is you do a deal and combine that with the financing afterwards. So given the runway that we have, that Stefan mentioned, Q1 2026, we feel very confident that we can finance the company at the right time when we have good data, which will drive the share price up. And in case that should not happen immediately, we will do a deal. So I'm just checking here. I don't see any further questions. That probably would lead to concluding remarks. So I think, as presented by Stefan or me, I think company BioInvent is a very strong position, not only financially, but also data-wise. Obviously, we're still early in clinical development, and that also explains the share price that we're currently seeing because if you analyze companies, especially in immuno-oncology, and look at companies that are either late preclinical or early clinical, they all more or less suffer the same fate. And also when you see the most recent cautious positive steps in the U.S., all the listings that you have seen so far were late-stage Phase II companies. So I think that explains the share price as you see it at the moment, but we feel quite confident that we will change that over time since we have a very interesting deal flow and new slope. And that obviously would drive a potentially interesting deal flow. Thank you very much for your interest and attention, and stay cute.