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

Thank you very much, and welcome, everybody, to our webcast covering our Q3 report. And I would like to go to the second slide, please. Thank you. So I would like to start with a quick summary of the highlights that we summarized also in our Q3 report, and I'll just go through this very quickly. So we were very pleased with our second clinical trial and supply agreement with Merck. This time for BI-1808 in combination with pembrolizumab. And I will come back to that later in a little bit more in detail. Then I'm pleased to announce that we will showcase our BI-1206, rituximab data in non-Hodgkin's lymphoma at ASH and that will be during December 11 to 14. And then we also will present early data by mid-December this year for BI-1206 in combination with pembrolizumab in the Phase I trial in solid tumors. We also have a poster on BT-001 preclinical data this time at SITC during November. And then I'm also very happy to tell you that we are on track for our CTA filing before year-end for BI-1607, which is our second anti-FcgRIIB antibody. Then on the company side, we're very happy to welcome Prof. Eggermont as a new member of the Scientific Advisory Board. And we also recently hired Emma Meurling as our new HR Director, basically strengthening our team. I would like to go to the next slide, please, which is Slide #4. Mind you, so obviously, you will remember that we have a portfolio strategy. That means we have a very interesting and strong pipeline with multiple value drivers, and I will briefly summarize it here on this slide, and then I will discuss the individual clinical trials separately. So when you look at this slide, you will see that we have basically 2 categories around 2 sets of targets. We have 3 programs around the target, which is called FcgRIIB, which is a very interesting target. It's the inhibitory sector, which is expressed on the cells of the innate immune system. And there we have basically 2 antibodies. One is BI-1206, which is our lead and this is going to be clinical development with rituximab for non-Hodgkin's lymphoma and work in combination with pembrolizumab in solid tumors. And just to remind you, so both trials are on track with the rituximab combination trial, we are at -- almost at the end of dose escalation. And with the pembrolizumab combination trial, we're still in dose escalation and recruiting patients as we speak. You will remember that we have signed a deal with CASI Pharmaceuticals providing CASI the rights for China, Taiwan, Macau and Hong Kong. And I'll come back to that later also, though, this collaboration is going very well. And then our first clinical supply and collaboration agreement with Merck is around the BI-1206 pembrolizumab combination. As already mentioned on the previous slide, so we have BI-1607, which is our second anti-FcyRIIB antibody. And there, we're close to initiate clinical development, and we are on track to find a CTA by the year-end. Then the second category is around targets that I expect on T-regulatory cells. There, we're currently focusing on 2 targets, one is TNF-receptor 2 and TNF-receptor 2 is 1 of the potentially hot and upcoming new immuno-oncology targets. And there we have 2 programs of which BI-1808 is our lead, which is also currently in clinical development, well recruiting, and this is our second clinical supply and collaboration with Merck, where we run 2 different arms on a single agent and the double agent is in combination with pembrolizumab. Then I also would like to mention BT-001 that we run in a 50-50 collaboration with TransGene. This is a combination of our proprietary anti-CTLA-4 antibody and Transgene's oncolytic virus platform. And this is also -- has been initiated at the beginning of this year and is also recruiting well. BI-1910 is our second anti-TNF-receptor 2 antibody, and this is still in preclinical development. So in the following slides, I will then go more in detail and discuss a little bit more around the various clinical development programs. So please go to Slide 5. Thank you. So this is BI-1206 in combination with rituximab. Just to remind you, so we are focusing, seen on the left, on patients who have relapsed or are refractory and we're mainly focusing currently on indolent and Hodgkin lymphoma, and the indication that we're looking at is mantle cell lymphoma, follicular lymphoma and marginal zone lymphoma. And as I already mentioned on the summary slide, so we are still in Part A of dose escalation, but we are towards the end. And currently focusing on 3 main work streams. So 1 is to define the dose for Part 2, preparing for end of Phase I we're doing with the FDA where we want to discuss the dose for Part 2, plus also the outline for potential pivotal study. And then we are working very diligently and very well together with CASI Pharmaceuticals and hopefully get the IND for China by the end of the year. More details we will provide, first of all, this program will be highlighted at ASH, but then also we are planning an event, a KOL event for the end of this year where we go in all detail regarding the current status of this program. So next slide, please, Slide 6. So this is then the second study that we're running, the BI-1206, which is in combination with pembrolizumab, focusing on solid tumors. And this runs under a clinical supply and collaboration agreement with Merck. Here, we're focusing on patients with solid tumors, who have relapsed or are refractory to anti-PD-1 and anti-PDL1. And here, we are still in dose escalation. And as I already mentioned on the previous slide, so here, we will also give an update on the status of this study at the end or during December, at the end of this year, in a KOL event that we're currently preparing. So the recruitment is going well, and we're quite excited about the early Phase I data that we have so far. Next slide, please, Slide 7. Other studies, yes. This is BI-1808. And this is basically the outline that we're running. You can see that we test this in a single agent arm as well as in combination with pembrolizumab. And at the beginning of this year, we started the single-agent study. We are well into recruitment. Recruitment is going very nice. And we are going to test it at the end in 3 indications, non-small cell lung cancer, which is a typically inflamed tumor, ovarian cancer, which is quite interesting. So when we identify TNF receptor 2 as a very interesting target. We did this with our first screen using ovarian cancer material from patients. So there's a nice link there as well. And obviously, currently, there is no successful immuno-oncology drug treating ovarian cancer. And then the third indication that we will look at is CTCL, which is a rare T-cell lymphoma, which also would provide the opportunity in case we see good data and efficacy in that indication for conditional approval and fast track. The combination with pembrolizumab, we will run for non-small cell lung cancer and ovarian cancer. And as you can see here, so we plan for a study update mid next year. I would like to go to Slide 8. Next slide, please. So this is then BT-001 and I mentioned already a little bit. So we identified with our first platform, our own proprietary anti-CTLA-4 antibody. And you're probably aware that there's ipilimumab, which is currently used. It's another anti-CTLA-4 antibody in the clinic. And our proprietary anti-CTLA-4 antibody is nicely differentiated from ipilimumab. In that sense, it does the same blocking, but it's a much stronger Treg-depleting antibody. So probably a more potent antibody remains to be seen in the clinic. And we have combined that with the oncolytics by platform of Transgene. Such that we basically transfect tumor lesions in order to ensure when the virus is replicating in the tumor cells that we have a very high exposure of anti-CTLA-4 in the solid tumor environment only. And a very low systemic exposure, which, of course, would lead to an improved toxicity profile of this program. We have started with the study. You see it on the left-hand side in Part A, at the beginning of this year. That's a single agent BT-001 intratumoral administration at ascending doses and the dose escalation is going quite well. And hopefully, then we can move it some time into Part B, currently in Part A. And we're planning to give a first update on the Phase I data during the first half of next year. With that, I would like to go to the next slide, and I believe, Stefan, this is the financial slide. So I will then hand over to you. And at the end, I will give a quick outlook of what we expect during the next couple of weeks and months this year.

Thank you, Martin. I will present the financial overview on Page 9 for Q3 and the 9-month period, January to September. All amounts are in SEK million, unless otherwise stated. Net sales were SEK 3 million in Q3 2021 compared to SEK 16.3 million in Q3 2020. That's a decrease of SEK 13 million. The decrease is related to lower revenues from production of antibodies for customers. Net sales for January, September 2021 was SEK 14.5 million. The same period in 2020, net sales were SEK 48.6 million. That's a decrease of SEK 34 million. The decrease is related to that revenues from production of antibodies for customers was SEK 27 million lower than in 2020. And also, there was no research ramping in 2021, which amounted to SEK 7 million in 2020. In Q3, operating costs increased from SEK 49.1 million in Q3 2020 to SEK 65.4 million in Q3 2021. We had mainly higher cost in BI-1206 and also higher costs in BI-1808 and BI-1910. There was lower cost for production of antibodies for customers, but we also had higher personnel costs. For January to September, the increase of operating cost was SEK 60 million from SEK 153.5 million in 2020 to SEK 214 million in 2021, which includes a onetime payment of GBP 2.5 million or SEK 28.4 million to CRUK in exchange for reducing BioInvent's obligations to CRUK regarding BI-1206. So we had significantly higher cost in BI-1206 due to the just mentioned payment to CRUK and also increased costs for the solid cancer study. We had also higher cost in mainly BI-1808 and BI-1910, had quite lower cost for production of antibody for customers and personnel cost was quite higher compared to 2020. The loss for Q3 2021 was minus SEK 62.6 million and the loss for January, September 2021 was minus SEK 199.7 million. The share issue completed in March 2021 amounted to SEK 962 million before issue expenses. And liquid funds together with long-term investments ended September month to SEK 1,445 million. That was my summary of the period. Over to you, Martin.

Thank you, Stefan. So I would like to go to Slide 10. So next slide, please. So I think what you said, Stefan, of course, is very much in line with our strategy. So of course, we have increased costs since we hired more personnel to ensuring the execution of all the clinical studies that we're doing. And then also in the manufacturing, we are focusing more internal programs currently, which also explains the decrease in revenues there for external. So thank you for that slide. So I think where I would like to end in this presentation is basically to outline again what to look for, for the rest of 2021. And just repeating what I already said, but I think it's good for the audience to understand what is coming up. It will require some busy weeks. So starting with BI-1206 in combination with rituximab in non-Hodgkin's lymphoma, we'll have a Phase I update at the ASH Annual Meeting. So that will be from December 11 to December 14, 2021. I also want to make everybody aware that, of course, once the abstract is published, that this is covering data that we had up to June, so just keep that in mind. Then we'll do a KOL event around BI-1206 for both, in combination with pembrolizumab in solid tumors where we present on the Phase I data, and then also BI-1206 with rituximab that will also have additional data to what we present at ASH, and we're planning to have this event in mid-December. Then I mentioned already, so hopefully, we'll have by -- during Q4, the China IND for BI-1206. So we're working together with CASI, who has been submitted quite some time ago. So hopefully, we get a positive feedback towards the end of this year. We're quite hopeful. And then I think the second anti-FcgRIIB program, BI-1607, there we are on track for the submission of the CTA, and that should happen by the end of this year. So as I said, quite eventful, and we are all quite excited to take off those various milestones. So I think thank you for your attention. And I think we should open up now for questions.

[Operator Instructions] Now first question comes from the line of Sebastiaan van der Schoot of Kempen.

I have 4 questions. The first 3 are on FcgRIIB, the 3 programs, and the last 1 is for Stefan. Just in general on FcgRIIB. Do you test on the level of FcgRIIB expression before enrolling patients in both the NHL program and solid tumor program or do you anticipate to do so in the future? Then the second 1 is on NHL. At the previous update in January, you mentioned that there were 2 additional patients recruited in the -- on the mid cohort, that you thought that you would not need to dose much higher. Since you mentioned that you are almost at the end of dose escalation, can you give a little bit of color on how recruitment has been since then? And on how many patients you expect to report clinical data on at ASH? And maybe also indicate when we can expect to hear more of the end of Phase I meeting? And then on 1206 in sold tumors, can you give a little bit of color on what early data constitutes? What will you report on? And then for Stefan, can you maybe give a little bit of guidance how you expect that expenses will grow in '22, seeing this will be the first year that you will have 4 to 5 clinical programs running?

Okay. Thank you, Sebastiaan. So before I start, obviously, you know and it was disclosed today that we have a KOL event in December, where a lot of those details, obviously, will be reported. But I will start to give you at least some flavor. So the first question that was the expression level. So what we're doing there actually is something different. So we have a collaboration with Skyline, and we are basically identifying signatures for patients who might be most likely very good responders. So that's on its way. And we might have also an update around that when we do the KOL even at the end of the year in December. Then yes, you remember probably what we disclosed during Q1. And then we already, I think, mentioned at some time point that we're at the end of dose escalation. We're still there. And of course, what that means is that we have even further escalated, but more details we will disclose when we do the KOL event. We'll not disclose it today. Now you have to help me a little bit, Sebastiaan. I think there was also a question around the pembro combination study of BI-1206, what kind of data to expect. We basically will tell you everything at that time when we disclose. So it will be on how the dose escalation went. There will be comments around what we see regarding safety, et cetera, and also other signals. I think I will leave it here. So we're -- but the only thing what I can tell you, so we're pretty excited to give that update. So you have to be patient until December when we provide this type of information during our KOL event that will cover both the rituximab combination as well as the pembro combination.

Yes. Okay. As you've seen in the report, we don't really give forecasts regarding operating costs for the full years '21 to '22. But we can say is that, as you saw in 2020, we had SEK 220 million in operating costs, and that has increased for the three 1st quarters, and it will increase next year. But what we can say is that we -- based on current plans, we foresee to have financing roughly until end of 2024, beginning of 2025. And that cash run could be extended somewhat if we get the upfronts from, example, new collaborations. So that's the guidance we can give.

Our next question comes from the line of Dan Akschuti of Pareto Securities.

So 1 question is a bit maybe more scientific, but I was wondering if 1910 is still scheduled to enter clinics next year? And if you also consider to combine this activating TNFR2 drug with the inhibiting one, 1808 in some program in this though -- where do you see that this mechanism could bring benefits?

Yes. So -- thank you, Dan. Basically, what I can say is those are 2 different programs. So 1808 is a blocker-deleter. That's how we call it. And 1910 is an agonist. And the current plan regarding initiating clinical development around 1910. So this is still in preclinical development, as you know, but I think the guidance would be that we would do that towards the end of next year. And I think at this stage, I will not disclose anything further regarding where we go with 1910, because this is still very much in the plans. But I think what is important for the audience is to understand those -- this is not a backup. So this is an antibody with a different mode of action than 1808.

Okay. And maybe a follow-up to -- do you see a potential triple combo there, considering in general, that comes through treatment are -- I mean, we see more and more mechanisms that are relevant and it seems like both the block here are very relevant. And would you plan more to go to sort of PD-1 inhibitors together? Or would you consider a triple combo approach there as well as maybe a similar bit that you have with BT-001?

Yes. So this is always a potential. So as we both know, so in cancer therapy, it's always nice when you see single agent activity. But at the end, we both know it will be a combination therapy after all, because otherwise it's difficult to really treat cancer or cure cancer. So this is always something that we consider and you can see from our various programs where all with you, we have disclosed what we're doing that we either have double combinations. As for the 1808, we do single agent activity, because we saw that preclinically, but we will also work for the combination. And in some cases, we'll also go for triple combinations. But I think I will keep those plans still for the time being with internal, because what we're always very concerned about is that we keep our competitive edge towards other companies that are working in the same area and the same space.

Okay. One more question on dose escalations. I would assume, I guess you won't tell me, but I would assume you went to up to 200 milligrams or so. And this for sure informed the trial with Keytruda in solid tumors. So can we expect maybe there that the dose escalation would be completed sometime mid next year?

You are asking regarding the pembro study, pembro combination study?

Exactly. Or if you can't be that specific, could you mention if the NHL trial from the other 1 in a way that should -- that you see that it's a bit faster to get to dose expansion stage for the solid tumor trial?

Obviously, as you say, so the data that we generate for the non-Hodgkin's lymphoma trial combination with rituximab, helps us to inform the pembro combination trial in solid cancers. And the only thing what I will tell you now since we will have the KOL event in December, and we want to keep our powder dry for that one, is that we could -- that we have the strategy to escalate as long as we see or -- yes, as long as we see and as long as we have reason to believe that, that could provide benefit to the patients. So that's the reason why we escalate. And of course, it's also very important to remember, I think, for the audience, this is the time we'll do it. So I think it's very important. And I think every time that we spend on that is well spent time to define the dose for Part 2 carefully, because this is the time to do it. Once we have selected it, that's the dose that we go for. And that's why we spend significant time to ensure that we have the right dose before we go to Part 2.

And considering that you escalated now longer than maybe originally anticipated, would that mean -- imply maybe that you have a very good safety profile, that you haven't had now any bigger immunomodulatory when going higher up?

Yes. So we have a good safety profile and 1 thing is clear. So whenever you deal with immunomodulatory drugs, you could expect, of course, as we have seen in the non-Hodgkin's lymphoma trial, infusion-related reactions. And that was obviously also part of the reason, and we disclosed that during Q1 when we showed the data, that things were going a little bit slower because you have to deal with that carefully, but with the dexamethasone treatment that we have then implemented afterwards, we controlled this pretty much. But wait for the detail in December.

Okay. And maybe 1 last question that you might not be able to answer, but once you reach dose expansion, can we expect also there may be additional combination and maybe an additional program as well with the same molecule?

You mean with BI-1206?

Yes.

Yes. So the current plans are clear, and that has been communicated. So obviously, non-Hodgkin's lymphoma it's -- there we are really focusing on rituximab, because just to remind everybody, rituximab is actually the treatment that physicians want to have for non-Hodgkin's lymphoma, because it's very safe. The side effect activity profile is very benign. And especially for those patients, who do not respond anymore to rituximab, and get those other therapies, which are currently available, they don't tolerate much side effects in the other therapies, which have been available for second and third line. They're efficient, but with a lot of toxicity associated. And the data that we've shown already in Q1 has shown that we have long-lasting effects and with a very good safety profile. So it's really all about quality of life. So that's what we're focusing on. But obviously, we're not excluding other combinations in that field, and we will talk about that a little bit when we give the KOL event. That's the non-Hodgkin's lymphoma.

[Operator Instructions] And there are no further questions at this time. Please go ahead, speakers.

Yes. Thank you very much for the questions from Dan and Sebastiaan, very good questions. And I'm just reminding everybody again, so in December, we have this broad KOL event that will cover BI-1206 6 in non-Hodgkin's lymphoma as well as in solid cancer. So we're very much looking forward to that. And besides this, I don't have any further comments. The only thing I can say is stay tuned, so it will be a busy end of the year. And there will be ample opportunities that we will talk to the shareholders. So the next 1 would be actually during the Redeye event in Stockholm, where I have a presentation that is -- not next week, but the week after next. And I'm very much looking forward to talking to whoever is there. Thank you very much.