Welcome to the BioInvent Q3 2021 report. For the first part of this call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. Today, I'm pleased to present the CEO, Martin Welschof. Please begin your meeting.
Thank you very much, and welcome everybody to our webcast covering our Q3 report. I would like to go to the second slide, please. I can't see the slide, so I don't know whether it's moving. Sorry. Hello? Stefan, do you see the slide? Now it's moving.
Yeah.
Okay, thank you very much. This is just our forward-looking statement. One slide further, please. Takes a long time, at least here for me. Can you?
Same here.
Stefan?
Same here.
Okay, then we just have to wait. Sorry for that. The third slide, please. Thank you. I would like to start with a quick summary of the highlights that we summarized also in our Q3 report, and I just go through this very quickly. We were very pleased with our second clinical trial and supply agreement with Merck this time for BI- 1808 in combination with pembrolizumab. I will come back to that later in a little bit more in detail. I'm pleased to announce that we will showcase our BI -1206 rituximab data in non-Hodgkin lymphoma at ASH, and that will be during December 11 to 14.
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. I'm also very happy to tell you that we're on track for our CTA filing before year-end for BI-1607, which is our second anti-FcγRIIB antibody. On the company side, we're very happy to welcome Professor Eggermont as a new member of the Scientific Advisory Board. We also recently hired Emma Meurling as our new HR director basically strengthening our team. I like to go to the next slide, please, which is slide number four. There we go.
Just to remind you, obviously you will remember that we have a portfolio strategy, that means we have a very interesting and strong pipeline, with multiple value drivers. I will briefly summarize it here on this slide, and then I will discuss the individual clinical trials separately. When you look at this slide, you will see that we have basically two categories, around two sets of targets. We have three programs around the target, which is called FcγRIIB, which is a very interesting target. It's an inhibitory receptor, which is expressed on the cells of the innate immune system. There we have basically two antibodies.
One is BI-1206, which is our lead, and this is currently in clinical development with rituximab for non-Hodgkin lymphoma and in combination with pembrolizumab in solid tumors. Just to remind you, both trials are on track. With the rituximab combination trial, we are almost at the end of dose escalation. 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. I come back to that later also, though this collaboration is going very well. Our first clinical supply and collaboration agreement with Merck is around the BI-1206 pembrolizumab combination.
As already mentioned on the previous slide, we have BI-1607, which is our second anti-FcγRIIB antibody. There we're close to initiate clinical development, and we are on track to file a CTA by the year-end. The second category is around targets that are expressed on T-regulatory cells. There we're currently focusing on two targets. One is TNF receptor 2, and TNF receptor 2 is one of the potentially hot and upcoming new immuno-oncology targets. There we have two programs of which BI-1808 is our lead, which is also currently in clinical development, well recruiting. This is our second clinical supply and collaboration agreement with Merck. There we run two different arms.
One is single agent and the doublet is in combination with pembrolizumab. Then, I also would like to mention BT-001 that we own in a 50/50 collaboration with Transgene. This is a combination of our proprietary anti-CTLA-4 antibody and Transgene's oncolytic virus platform. This also has been initiated at the beginning of this year, and it's also recruiting well. BI-1910 is our second anti-TNFR2 antibody, and this is still in preclinical development. In the following slides, I will then go into more detail and discuss a little bit more around the various clinical development programs. Please go to slide five. Next slide, please. Slide five, please. Thank you. This is BI-1206 in combination with rituximab, just to remind you.
We are focusing, see it on the left, on patients who have relapsed or are refractory and currently focusing on indolent non-Hodgkin lymphoma. The indication that we're looking at is mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. As already mentioned on the summary slide, we are still in part A, dose escalation, but we are towards the end and currently focusing on three main work streams. One is to define the dose for part two, preparing for end-of-phase I meeting with the FDA, where we want to discuss the dose for part two, plus also the outline for potential pivotal study. 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'll provide. First of all, this program will be highlighted at ASH, but then also we're 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. Next slide, please. Slide six. Next slide, please. Thank you. This is then the second study that we're running with BI-1206, which is in combination with pembrolizumab, focusing on solid tumors. 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-PD-L1. Here we are still in dose escalation.
As I already mentioned on the previous slide, 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. 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 seven. Next slide, please. Now I want to go to the next slide highlighting the other studies. Yes, this is BI-1808. You know, 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.
At the beginning of this year, we started the single agent study. We're well into recruitment. Recruitment is going very nice. We are going to test it at the end in three indications. Non-small cell lung cancer, which is a typically inflamed tumor. Ovarian cancer, which is quite interesting. When we identified TNFR2 as a very interesting target, we did this with our first screen using ovarian cancer material from patients. There's a nice link there as well. Obviously, currently, there's no successful immuno-oncology drug treating ovarian cancer. 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, and that's indication for conditional approval and fast track.
The combination with pembrolizumab will run for non-small cell lung cancer and ovarian cancer. As you can see here, we plan for a study update mid next year. I would like to go to slide eight. Next slide, please. There I would like to discuss the BT-001 study. Next slide, please. Thank you. This is then BT-001, and I mentioned already a little bit. We identified with our first platform our own proprietary anti-CTLA-4 antibody. You're probably aware that there's ipilimumab, which is currently used. It's another anti-CTLA-4 antibody in the clinic. Our proprietary anti-CTLA-4 antibody is nicely differentiated from ipilimumab. In that sense, it does you know the same blocking, but it's a much stronger T-reg depleting antibody.
Probably a more potent antibody remains to be seen in the clinic. We have combined that with the oncolytic virus 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 the study you see 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. You know, the dose escalation is going quite well.
Hopefully then we can move at some time into part B. We're 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. I will then hand over to you, and at the end, I will give a quick outlook what to expect during the next couple of weeks and months this year. Next slide, please.
Thank you, Martin. I will present the financial overview on page nine for Q3 and the nine-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 low 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. Also there was no research funding 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 costs in BI-1206 and also higher costs in BI-1808 and BI-1910. There was lower cost for production of antibodies for customers. We also had higher personnel costs. For January to September, the increase of operating costs was SEK 60 million from SEK 153.5 million in 2020 to SEK 214 million in 2021, which include a one-time 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.
We had significantly higher costs in BI-1206 due to the just mentioned payment to CRUK and also increased costs for the solid cancer study. We had also higher costs in mainly BI-1808 and BI-1910. We had quite low costs for production of antibodies for customers, and personnel costs was quite higher compared to 2020. The loss for Q3 2021 was SEK -60.6 million, and the loss for January-September 2021 was SEK -199.7 million. The share issue completed in March 2021 amounted to SEK 962 million before issue expenses. Liquid funds together with long-term investments end of September amounted to SEK 1,445 million. That was my summary of the period. Back to you, Martin.
Thank you, Stefan. I would like to go to slide 10. Next slide, please. While we're waiting for this, I think what you said, Stefan, of course, is very much in line with our strategy. Of course, we have increased costs since we hired more personnel to ensuring the execution of all the clinical studies that we're doing. Then also in the manufacturing, we are focusing more on internal programs currently, which also explains the decrease in revenues there for external. Thank you for that slide. 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.
It's 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. Starting with BI-1206 in combination with rituximab and non-Hodgkin lymphoma , we'll have a phase I update at the ASH annual meeting. That will be from December 11th 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. Then we'll do a KOL event around BI-1206 for both, you know, in combination with pembrolizumab and solid tumors, where we present early phase I data. Then also BI-1206 with rituximab.
You know, that will also have additional data to what we present at ASH, and we're planning to have this event in mid-December. I mentioned already. Hopefully, we'll have by during Q4 the China IND for BI-1206. We're working together with CASI. It has been submitted quite some time ago, so hopefully we get a positive feedback towards the end of this year. We're quite hopeful. I think the second anti-FcγRIIB unique program, BI-1607, there we're on track for the submission of the CTA, and that should happen by the end of this year. As I said, quite eventful. We are all quite excited to tick off those various milestones.
I think, thank you for your attention and I think we should open up now for questions. Thank you.
Ladies and gentlemen, if you have a question for the speakers, please press star one on your telephone keypad. Our first question comes from the line of Sebastiaan van der Schoot of Kempen. Please go ahead.
Hi, Martin. Hi, Stefan. I hope you're all well. I have four questions. The first three are on FcγRIIB, the three programs, and the last one is for Stefan. Just in general, on the FcγRIIB, do you test on the level of FcγRIIB expression before enrolling patients in both the NHL program and solid tumor program, or do you anticipate to do so in the future? The second one is on NHL. At the previous update in January, you mentioned that there were two additional patients recruited in the 100 mg cohort, and 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? Maybe also indicate when we can expect to hear more of the end-of-phase-I meeting. On BI-1206 in solid tumors, can you give a little bit of color on what early data constitutes? What will you report on? For Stefan, can you maybe give a little bit of guidance how you expect that expenses will grow in 2022, seeing this will be the first year that you will have four to five clinical programs running?
Okay. Thank you, Sebastiaan. 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. I will start to give you at least some flavor. The first question, that was the expression level. What we're doing there actually is something different. We have a collaboration with SciLifeLab, and we are basically identifying signatures for patients who might be most likely very good responders. That's on its way, and we might have also an update around that when we do the KOL event at the end of the year in December.
Yes, you remember probably what we disclosed in 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. Of course, what that means is that we have even further escalated. More details, you know, we will disclose when we do the KOL event. We will 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-
Yeah.
You know what to expect. We basically will tell you everything at that time when we disclose. We'll 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. The only thing what I can tell you, so we're pretty excited to give that update. 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.
Okay, great.
I don't want to.
Okay.
Uh-
Stefan.
Yeah. Okay. As you've seen in the report, we don't really give forecasts regarding operating costs for the full years 2021 to 2022. What we can say is that as you saw in 2020, we had SEK 220 million in operating costs, and that has increased for the first three quarters. It will increase next year. What we can say is that we, based on current plans, we foresee to have financing roughly until end of 2024, beginning of 2025. That cash run could be extended somewhat if we get the up-fronts from example new collaborations. That's the guidance we can give.
Okay, great. That's very helpful. Thank you.
Our next question comes from the line of Dan Akschuti of Pareto Securities. Please go ahead.
Thank you for taking my question. One question is a bit maybe more scientific, but I was wondering if BI-1910 is still scheduled to enter clinic next year, and if you also consider to combine this activating TNFR2 drug with the inhibiting one, BI-1808 in some program? If so, where do you see that this mechanism could bring benefits?
Thank you, Dan. Basically, what I can say is those are two different programs. 1808 is a blocker depleter, that's how we call it, and 1910 is an agonist. The current plan regarding initiating clinical development around 1910, 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. I think at this stage, I will not disclose anything further, you know, regarding where we go with 1910 because this is still very much in the plans. I think what is important for the audience is to understand this is not a backup. This is an antibody with a different mode of action than 1808.
Okay. Maybe a follow-up. Do you see a potential triple combo there, considering in general that cancer treatments are. I mean, we see more and more mechanisms that are relevant, and it seems like both that are blocked here are very relevant. Would you plan more to go just for PD-1 inhibitor together, or would you consider a triple combo approach there as well as maybe similar a bit as you have with BT-001?
Yeah. This is always a potential. As we both know, in cancer therapy, it's always nice when you see single-agent activity. 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. This is always something that we consider, and you can see from our various programs where already we have disclosed what we're doing, that we either have double combinations. You know, as for the 1808, we do single-agent activity because we saw that preclinically. We will also go for the combination, and in some cases we'll also go for triple combinations.
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 same space.
Okay. Thank you. One more question on those escalations. I would assume, I guess you won't tell me, but I would assume you went up to 200 milligrams or so. This for sure informs the trial with KEYTRUDA and solid tumors. Can we expect maybe there that the dose escalation would be complete at sometime mid next year?
You're asking regarding the pembro study, pembro combination study?
Exactly. If you can't be that specific, could you mention if the NHL trial from the other one in a way that you see that it's a bit faster to get to dose expansion stage for the solid tumor trial?
Obviously, as you say. The data that we generate for the mantle cell lymphoma trial combination with rituximab helps us inform the pembro combination trial in solid cancers. 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 that we have the strategy to escalate as long as we see and as long as we have reason to believe that that could provide benefit to the patient. That's the reason why you escalate. Of course, it's also very important to remember, I think for the audience, this is the time where you do it.
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 two carefully. Yeah, because this is the time we do it. Once you have selected it, that's the dose that we go for, and then that's why we spend significant time to ensure that we have the right dose before we go to part two.
Thank you. 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 noteworthy event even when going higher up?
Yeah. We have a good safety profile and one thing is clear. Whenever you deal with immunomodulatory drugs, you could expect, of course, as we have seen in the non-Hodgkin lymphoma trial, infusion-related reactions. 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. You know, wait for the detail in December.
Okay. Thank you. Maybe one last question that you might not be able to answer, but once you reach those expansion, can we expect also there may be additional combination, maybe an additional program as well with the same molecule?
You mean with BI-1206?
Yes.
Yeah. The current plans are clear, and that has been communicated. Obviously non-Hodgkin lymphoma, it's they will be focusing on rituximab because, just to remind everybody, rituximab is actually their treatment that physicians want to have for non-Hodgkin lymphoma because it's very safe. You know, the cytotoxicity 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. The other therapies which have been available for second and third line, they're efficient, but with a lot of toxicity associated. The data that we shown already during Q1 has shown that we have long-lasting effects and with a very good safety profile.
It's really all about quality of life. That's what we're focusing on. Obviously we're not excluding other combinations in that field. We will talk about that a little bit when we give the KOL event. That's the non-Hodgkin lymphoma.
Okay.
Yeah.
Thank you very much.
Thank you, Dan.
Just to remind everyone, if you would like to ask a question, please press 01 on your telephone keypads. There are no further questions at this time. Please go ahead, speakers.
Yes. Thank you very much for the questions from Dan and Sebastian. Very good questions. I'm just reminding everybody again. In December we have this broad KOL event that will cover BI-1206 in non-Hodgkin lymphoma as well as in solid cancer. We're very much looking forward to that. Besides this, I don't have any further comments. The only thing I can say, stay tuned. It will be a busy end of the year, and there will be ample opportunities that we will talk to the shareholders. The next one will be actually during the Redeye event in Stockholm, where I have a presentation that is not next week, but the week after next.
I'm very much looking forward to talking with whoever is there. Thank you very much.