Welcome to the BioInvent Q4 report conference call. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to the speakers CEO, Martin Welschof, CFO, Stefan Eriksson. Please go ahead. Call recording is on. Thank you very much, welcome everybody to our call. We'll right jump into the first slide. It's here, Martin Welschof, the CEO, and Stefan Eriksson, the CFO. Our forward-looking statement and then the summary. Basically, I just want to go briefly through the events during the fourth quarter. We started our phase I trial with the subcutaneous formulation of BI-1206. We received notice for allowance in the U.S. for a quite important patent covering BI-1206 and BI-1607. As I will show you later, we had strong progress in clinical and pre-clinical projects. Our pipeline was growing basically forward as projected and planned. That was also covered during our R&D day that we had in December 2022 in Stockholm. The other thing that we also were quite proud about was that BioInvent and Transgene had a joint paper on BT-001, which is our joint collaboration. We won the JITC Best Oncolytic and Local Immunotherapy Paper Award for 2022. We also received, last but not least, IND FDA approval for the anti-FcγRIIB antibody, our second candidate, which is BI-1607. We had an event after the end of the period, and that was that we have been selected by The Leukemia & Lymphoma Society Therapy Acceleration Program and received a $3 million strategic equity investment. I want to elaborate on that a little bit more on the next slide. Obviously, it's nice to receive that recognition and the money, but I think what is really important, that this collaboration or this organization will collaborate with us very closely and make sure that we advance as we have planned, you know, getting contacts to the right sites, to the right network. This is really endorsing mainly our main program, our lead program, BI-1206. The non-Hodgkin, the The Leukemia & Lymphoma Society really got the very unique positioning that we have for BI-1206. Of course, they are also quite interested in the application of BI-1808 in Cutaneous T-cell lymphoma. We are quite proud about this. That was a quite detailed due diligence that they have done on those two programs, and we feel that this is a very important external validation and will also help us to progress our clinical development in those two areas significantly. I will go basically quickly over the program. As you know, we have started our subcutaneous formulation clinical development for BI-1206 as planned. Just to remind you, see in the bottom of in the bottom of this slide that we have very impressive early efficacy data, especially long-lasting complete responses that are still ongoing and a couple of partial responses. A nice overall response. We were mostly impressed by the long-lasting complete responses. As you might remember, we had some infusion-related reactions associated with BI-1206, which we could control with steroid treatment and split dosing. We basically pre-clinically checked a subcutaneous formulation that we developed in-house and could see that we with the subcutaneous formulation pre-clinically could eliminate those infusion-related reactions completely. Which means that we basically started to develop this early last year and put it into the clinic end of last year, which is quite quick and also is a nice showcase for the competitive advantage that we have, that we have not only research and discovery, clinical development, but also manufacturing all under one roof. This is going very, very well with the dose escalation, and we hope to have the first data as outlined, and I'll come back to the key milestones later, during the first half of this year. Just to summarize what we have achieved with BI-1206 and non-Hodgkin lymphoma. The key milestones are listed here. We selected the dose for part two. This is for the IV. We had an end of phase 1 meeting with the FDA, which was successful. We started also to include China in our global clinical development strategy and started to recruit the first patients there. As already mentioned in more detail, we have developed our own sub-Q formulation, and that is running in the clinic nicely since the end of last year. Moving to the next program, which is BI-1206, but now in combination with pembrolizumab for solid cancers. You would remember that we're there still in dose escalation. We had some early observations that would indicate that BI-1206 with pembro may reverse metastatic disease progression in patients who have previously progressed on PD-1 or anti-PD-L1 therapies. We had two published responders. That is also nicely progressing. You can see here we're still in dose escalation, and then we plan, once we are in dose expansion, to go for non-small cell lung cancer, metastatic melanoma, and other tumor types. Also, for this study, once we have tested the sub-Q, we'll also enroll the sub-Q formulation of BI-1206 in the combination with pembrolizumab. The next program is BI-1607. six and oh seven is our second anti-EpCAM R2B program, which is basically a modification of twelve oh six. It has one amino acid mutation actually, which makes it Fc-silent. We started last summer with an open-label clinical trial in combination with trastuzumab. This is also enrolling nicely, and we're currently enrolling patients in Europe, and also, as I already mentioned, we have an FDA IND approval since November 2022. This data for this study, the first data actually, should be available during the second half of this year. eighteen oh eight, our lead TNF receptor two program, that we run as a single agent as well as in combination with pembrolizumab. We're currently enrolling patients. The phase one Part A planned dose escalation has been completed. We have decided, as we already communicated during the R&D meeting in December, to go one dose higher, 1,000 milligrams. This dose cohort is going to be ongoing. We have kicked off the Part B combination. That means BI-1808 in combination with pembrolizumab at the end of last year. We observed already some responses. We had three stable disease and one very interesting non-small cell lung cancer patient where we could see 20% tumor reduction. We didn't have any safety and tolerability issues. This is running as planned. The next milestones, and I will summarize at the end all the milestones again, will be for the single agent, during the first half of this year, the first dataset, and then for the combination, during the second half of this year. Continuing to the next program, last but not least, our collaboration, joint venture with Transgene. Just to remind everybody, this is our proprietary anti-CTLA-4 antibody combined with the oncolytic virus platform of Transgene. We have, you know, we're running it currently as a single agent, BT-001, into tumor administration at descending doses. We observed some responses, we had initial data from Part A. It was showing that BT-001 is well-tolerated and, as I said, we had first signs of antitumor activity in a hard-to-treat patient population, and we confirmed the mode of action for BT-001 as a single agent. The next step there will be then combining it also with pembrolizumab. There's an update. We were hoping to start it during the first half of this year, but that will move into the second half of this year. I think that leads then over to the financials and I hand over to Stefan. Thank you. I represent the financial overview for Q4 and the 12 months period, January - December. All amounts are in SEK million, unless otherwise stated. Net sales were SEK 20.6 million in Q4 2022 compared to SEK 4.9 million in Q4 2021. That's SEK 16 million higher in 2022. The increase is related to that revenues from production of antibodies for customers was SEK 7 million higher in 2022, also there was research funding in 2022, which amounted to SEK 9 million. Net sales for January to December 2022 were SEK 326.1 million. For the same period in 2021, net sales were SEK 19.4 million. That's an increase of SEK 307 million. The increase is related to that we in 2022 received an upfront payment of $25 million when we signed an agreement with Exelixis. We also received a EUR 0.5 million milestone from Bayer. The increase in 2022 is also related to that revenue from production of antibodies for customers was SEK 33 million higher. There was also research funding in 2022, which amounted to SEK 13 million. Operating costs increased from SEK 84 million in Q4 2021 to SEK 100 million in Q4 2022. That's an increase of SEK 16 million. We had somewhat higher costs in BI-1910 and for production of antibodies for customers. We had somewhat lower costs in BI-1607. We had quite higher personnel costs in Q4 2022. For January to December, the increase of operating costs was SEK 79 million, from SEK 298 million in 2021 to SEK 377 million in 2022. During the period, we had quite higher costs in BI-1910, BI-1607, and higher costs for production of antibodies for customers. We also had somewhat higher costs in BI-1808. We had quite lower costs in BI-1206, and personnel costs were quite higher compared to 2021. The loss for Q4 2022 was -SEK 78.3 million, and we had a loss for January to December 2022 of SEK 42.5 million. The share issue completed in July amounted to SEK 299 million before issue expenses. Liquid funds, current and long-term investments end of December amounted to in total SEK 1.594 billion. Okay. Thank you, Stefan. That leads me to our last slide in the presentation, as I already mentioned at the beginning, I just want to summarize the key milestones for this year. I mentioned them already when we were talking or discussing the various programs, I'm summarizing those here again. As already mentioned, we are expecting the first results for the phase I subcutaneous 1206 in combination with rituximab during the first half of this year. Also as mentioned, we will start the phase I sub-Q for 1206 and pembro also during the first half. I think that is quite important in the context of infusion-related reactions, not only because of course, it's also a much in... more interesting product because much more easy to handle and to apply. On our TNFR2 program, BI-1808, there we expect the first data set as a single agent during the first half of this year. We have a couple of milestones coming up during the second half. I mentioned already that BT-001, this is shifting from first half to second half, the combination study to be kicked off with Keytruda. There are two more data sets there that we are expecting. BI-1808 in combination with pembro, that should be also during the second half. 1607, our second anti-FcγRIIB program in combination with trastuzumab, that we also expect the first data set during the second half of this year. I didn't mention 1910, this is our second anti-TNF receptor two program, and this plans to be started, the clinical development, also during the second half of this year. You can see how we approach, and this is due also to our platform, how we discover targets and antibodies. Normally we would not have 1 candidate, but we have several candidates per target. Normally, we're not choosing them all, but that's the case. That's why we can really build then platforms around the targets because then we would not only have 1 compound, but only 2, as you can see for FcγRIIB as well as TNFR2. I think this is the end of our presentation. Thank you very much for your attention, and I think we shift over to Q&A. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from... Please introduce yourself. Please go ahead. Hello? Hello. Hello. Can you hear me? Yes. Is that Richard? Yeah, yeah. Sorry, I, I didn't... Thought you should go ahead to talk, and you didn't mention my name. Yes, this is Richard Ramanius from Redeye. Nice to meet you, Richard. No, my Yeah, yeah, sorry about that. No, my first question, if it was related to contract manufacturing. If you could just repeat if did I hear you right, you had turnover SEK 33 million in 2022. Is that correct? No, we had an increase. Let me see what we had in. We had SEK 52 million in manufacturing for customers in 2022, and we had SEK 19 in 2021. Okay. Yeah, that's quite a large increase. Could you say anything about what you think would be a normal level? Do you typically have large variations? That will vary, over the years because we also use the capacity for our own projects. Yeah. Yeah. Maybe you can also make an additional comment here, Richard. As you would know, since now, I would say almost four years, we are focusing mainly on our own pipeline portfolio that we are, you know, supporting not only with manufacturing but I mentioned also subcutaneous formulation. That's number one priority. What we do, and of course, we make a very accurate planning there, and once we know we have slots available, then we slot in external. That can vary. But I can tell you in any way, currently the request or the interest is quite high. There's a lot of companies out there that need manufacturing such that we can easily fill the slots that we have available with external manufacturing. Okay. Wouldn't you need to increase the production of antibodies in your tumor products going forward as you progress to the expansion cohorts, which will be a lot larger? Well, the production for, you know, phase I, phase II is no problem at all. We do that in-house. As you might remember, we don't have the possibility to produce commercial at BioInvent. We can do phase II, phase I, phase II, and phase III, but not commercial, which means that normally once you have, you know, done those expansion and you have proof of concept, then you generate a transfer to a commercial manufacturing unit. That's what we already prepare in parallel, for instance, for BI-1206. Yeah. Okay. I got it. Also wanted to ask you about the timeframe for BI-1206, how much has it shifted forward due to the introduction of the subcutaneous formulation compared to the original plans? Yeah. Basically what you can say is that, you know, dose escalation for sub-Q is running. As we said, we will expect that during the first half of this year, then we move into dose expansion. The IV dose expansion is also open, but we don't push it because we really have the main focus on sub-Q. The delay is really mainly that we have to do the dose escalation, which is a quick one in any way, but that we have to do the dose escalation for sub-Q, which was of course not originally planned. Yeah. Okay. My final question, which I know you got before about bispecific T-cell engagers, 'cause Lunsumio was approved in the EU this summer, and now it was approved in the US, and there are other versions as well that are very close to approval. Could you say, how do you see that affecting your potential market share in later lines of lymphoma? Yeah. As you can see, that's why I also spent some time on the collaboration that we have now started with The Leukemia & Lymphoma Society. They're obviously very much aware of what happens in non-Hodgkin lymphoma and other liquid cancers. They feel that we have a very unique positioning also regarding those compounds that you have said, because most of them have toxic effects, which makes them very critical for second and third line patients because those are very fragile patients, and that's where we start. Also one comment from The Leukemia & Lymphoma Society is that, you know, bispecifics and maybe also CAR-Ts, besides the toxicity that I've mentioned, is actually not what the normal hospital would prefer. They, they might run at large centers, but they feel, and that's why they came to us and endorsed us and started the collaboration, gave us the money, $3 million, is that CD20-based therapy, rituximab and similar biosimilars to rituximab will remain central in non-Hodgkin lymphoma for at least another 10 years-20 years. That's why they feel that we're so uniquely positioned because once we have shown in third and second line that we can not only rescue a patient that do not respond anymore to CD20-based therapy, but maybe also enhance on that, then we can also move to first line. To cut a long story short, yes, we know it's a competitive market, but we have a super unique positioning that nobody else has. Keep in mind that the CAR-T and bispecific approaches, they have a much stronger toxic profile than we have. You know, we just have infusion-related reaction. That's why we developed the sub-Q. They see much more than that. Yes, they're effective and there's approvals, but I think based on the safety profile, the unique positioning together with anti-CD20-based therapy, we feel we have clearly an edge also towards those bispecific as well as CAR-T approaches. Yeah. Okay. Those, those were my questions, thanks. Thank you, Richard. The next question comes from number 41798926. Please go ahead. Hello, can you hear me? Yes. Is that Sebastian? Hi. Hi. It's, it's Dan. It's Dan Akschuti from Pareto Securities. Oh, okay. Hi. Hi, Dan. Yeah. Nice to meet you. Hi. I'm Martin. Thanks for the nice presentation and, looking forward to the event for 2023. My question is, so for the sub-Q formulation of BI-1206 in solid tumor, that is expected to start in the first half of the year, could you provide more details, like will it follow the same sort of adaptive study design as in NHL? Yeah. What we will do, when we start the study, we will provide the details. It's currently something that we keep close to our chest. I think I would ask you for some patience. Once we started, the study design and everything will be available. Okay. Thank you. Yeah, maybe another question. The equity investment from The Leukemia & Lymphoma Society, apparently serves as a strong validation of your technology. I'm wondering what kind of collaboration do you expect to see in the near future? Yeah. Basically the way that works is that they really become a part of our, in a way, in our extension of our clinical development around BI-1206 in non-Hodgkin lymphoma and BI-1808 in CTCL. That was already, and I can tell you, the due diligence that they have done in those two areas, I have not seen any stronger due diligence or deeper due diligence before here at BioInvent during my time. Really they looked at those two programs in all detail and on all levels. That also will give you an indication how closely they will collaborate with us. They really will help us with clinical sites, with key opinion leaders. We already have been brought into contact through their network to a number of interesting investigators. Their focus will be to help us as much as they can, that we recruit as quickly as we can and have the best sites. That's what they try to provide. Okay. Yeah. Thank you very much. Thank you, Dan Akschuti. The next question comes from number 3165368. Please go ahead. Good morning or, good afternoon, everyone. Thank you for taking my questions. Can you hear me? Yes, Sebastian, we can hear you loud and clear. Hey. Yes. This is Sebastiaan from Kempen. Yeah, thank you for taking my questions. I had two on BI-1206 in non-Hodgkin's lymphoma. I'm wondering whether you can maybe expand on whether you expect with the subcutaneous formulation, whether that can also translate into high efficacy compared to the IV formulation in non-Hodgkin's lymphoma. A second one would be, I think that you just mentioned that we expect first dose escalation data in H1 and then continuation with dose expansion. I expect that you would only continue with dose expansion with the sub-Q formulation. Can we already expect that in H2 2023? The final question is regarding R&D expansion, SG&A expansion in 2023. Will that be in line with 2022? Thank you. Very good. I try to remember. You were asking, yes, now I remember what your first question was. This is Martin, obviously. Yes, I think there's a possibility. Obviously, keep in mind that the responses that we have seen were already at a relatively low doses, so they're. I don't have them all in front of me. We saw good response already lower. We have picked 100 mg as a dose for part II for the IV. What we will do, we hope, let's put it that way. We hope that with the sub-Q that we can go higher, and we will do that. We will explore that and see whether that has an influence. Let's put it that way. What, you know, we expect, I don't know. We'll see. We will anyway use the subcutaneous formulation also to go to higher doses. Yes. Your second question was also related to, you know. Yeah. Dose expansion IV and dose expansion sub-Q. Yeah. More the timing- So- -of the event, Martin. Sorry to interrupt. Yes, no problem. The currently, as I already mentioned during the presentation, both IV arms, BI-1206 in combination with rituximab and BI-1206 in combination with pembrolizumab are both open. We continue, we can, again, still include patients. Obviously our push and our emphasis on sub-Q for all the reasons that we already have discussed. The idea would be really once we can, we know that we see the same efficacy, got completely rid of the infusion-related reactions, then we will push ahead with sub-Q only. The timing, I'm not 100% sure about, but as quickly as possible. You can, you know, extrapolate a little bit. We expect the first data set or have basically more or less finished and have the first data set for the escalation during the first half of this year. Then there might be some, you know, times that you have to do further analysis and waiting time, and then we will, you know, move into the dose expansion right thereafter. That's a little bit fluid at the moment because it will really depend on this data set that we are currently generating in the dose escalation. We want to move ASAP, basically. Yeah. Got it. Is the expectation also that dose escalation will be faster with the sub-Q formulation compared to what we have seen before with the IV formulation? Yes. We had to be quite careful with dosing in IV because we had infusion-related reaction even though we could control it with steroid treatment and with split dosing, which was quite successful. It was still there once in a while. We were very careful, and that's why we didn't push it. Once we know we have something, and also the investigators know we have something that this eliminates completely, and also it's much more easy to apply, then it should be quicker. Yes. Especially also with the help of LLS, The Leukemia & Lymphoma Society. Okay. Got it. Thank you. Then the final question was on the R&D expenses and SG&A expenses in 2024. Yeah. Stefan here, I can comment that one. We had in operating cost last year, 2022, SEK 377 million. With soon six clinical programs running, costs will increase, of course. We don't really give a forecast for that, but what we can say, as we said before, we would have be financed until the end of 2025, as it looks like now. Got it. Thank you very much. Thank you, Sebastiaan. As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. There are no more questions at this time. I hand the conference back to the speakers for any closing comments. Thank you much, everybody, for, you know, listening in and also for the questions. I think, in summary, as you can look at BioInvent, we're a fully integrated company with target discovery, antibody discovery, cell line generation capability, manufacturing, and clinical development. Well-funded, with first-in-class compounds currently from five clinical trials running, at the end, hopefully six as planned. You know, looking into this year, we mentioned that we will have first data sets, mainly dose escalation. Still, you know, that will be an early glimpse into the potential of our portfolio. Obviously, 2024 will be even more interesting because then we move into deeper into phase two with the first program. I think, a very exciting time ahead. As Stepan said, well-funded in order to tick off those value inflection milestones. Again, thank you very much for your attention. With this, I close the meeting. Bye-bye.