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

Welcome to the Bioinvest (sic) [ BioInvent ] audiocast, the teleconference Q4 2021. [Operator Instructions] Today, I am pleased to present Martin Welschof, CEO; and Stefan Ericsson, CFO. Please begin your meeting.

Thank you very much, and welcome, everybody, to our quarterly call. And I would like to start with a brief summary of the events that happened during the last quarter. So we had positive interim data from our lead program, BI-1206 in non-Hodgkin Lymphoma, where we could see increased and sustained responses in relapsed patients, and that was particularly very impressive in follicular lymphoma. And then at the same time also, we released positive early clinical data from BI-1206 in combination with pembrolizumab for solid tumors. We also made good progress in our collaboration with CASI Pharmaceuticals, so we received the IND for China for clinical studies in China at the end of last year. And then we also -- we're very proud that we advanced to the NASDAQ Stockholm's Mid Cap segment. And last but not least, we also got orphan drug designation granted for BI-1206 which was very important also from a strategic clinical development perspective, and we got that for follicular lymphoma. Then we published a very nice publication in Journal of Immunotherapeutic -- ImmunoTherapy of Cancer, together with Transgene and that was about our preclinical data with BT-001, where we could show a very convincing proof-of-concepts for our 50-50 collaboration with Transgene. And I will come back to that later also a little bit more in detail. Then, as you know, we are currently running 4 active clinical programs, and we also got the CTA approved for our fifth program at the end of last year, which is BI-1607, and there we should also start clinical development then during the first half of this year. We also then further built the organization. So we extended quite a bit, especially in clinical, but also in the other 2 departments, which means manufacturing and research and discovery. And we appointed a key position with Marie Moores, and she was appointed Chief Operating Officer, and we're very happy to have her on board. Then on the next slide here, you will get a little bit of background again, just as a reminder, on BI-1206 in combination with rituximab, this is our lead program. This is a Phase I/IIa study that you see outlined on this slide. And I just want to mention here that we are focusing on patients who have relapsed or are refractory indolent non-Hodgkin lymphoma, specifically marginal zone lymphoma, follicular lymphoma and mantle cell lymphoma. And we're now at the end of the dose escalation, which is Part A, and we are about to move into Part B, which is the dose expansion. So just to summarize the data that we basically presented at the end of last quarter. So for BI-1206, in combination with rituximab, we could show a strong objective response of 54%. We had 3 complete responses and 4 partial responses in 13 patients that could be evaluated at that time point. And the treatment stabilized disease in 1 additional patient, actually giving a disease control rate of 62%, 8 patients out of 13. The important thing here really is to emphasize that the complete responses that we have seen are high-quality complete responses. That means they are long lasting, beyond 12 months, 24 months and 36 months in 3 patients. And just to give you an idea, so the 36 months patient that was in treatment for 1 year and is now 2 years in complete response without any additional treatment, which is, I think, very exciting. The safety profile of BI-1206, as outlined here, is good. So we had some infusion-related reaction that we could manage very well with a novel steroid regimen. And BI-1206 shows actually a highly promising response rate in patients with high medical needs. On the next slide, you will see that we're focusing on follicular lymphoma, where we had especially impressive response rates. So there, we are looking at 9 patients at that time when we released the data. And in those 9 patients, we had an overall response rate of 67%, a disease control rate of 78%, 3 complete responses with the long durations that I already mentioned on the previous slide. And as I already said, so the longest complete response is still lasting 24 months after the end of treatment, in addition to the 3 complete responses, 3 partial responses and 1 stable disease, so very impressive data. So on this slide, you see then the next key milestones that are up and coming. So we're about to select the dose for Part 2 and then move into the expansion phase, Part B, as I already explained. We have a date for the end of Phase I meeting with the FDA. Doing that, we'll discuss the dose for Part 2 and then the Phase II study design, which potentially could be a pivotal study. As you already have learned, so we have successfully filed in collaboration with CASI an IND for China. And we are now about to include China in our global clinical development strategy, and that will be implemented during Part B. And then we actually also have developed a subcutaneous formulation and that will be ready to be tested in the clinic during the second half of this year. So actually, quite a number of interesting key milestones. Then going to the next slide. So you will see the outline of the other study that we're running with BI-1206, in this case, in combination with pembrolizumab, targeting solid tumors. On the left-hand side, you see that we're focusing on patients with solid tumors who have relapsed or are refractory to anti-PD1 or anti-PD-L1 treatment. It's a similar design, so it's basically Part A, which is dose escalation. And then after that, we go into Part B into dose expansion. It's worth to mention that we run this study in collaboration with Merck, which is a clinical supply and collaboration agreement, and we're still in early phases of the dose escalation phase. Nevertheless, we could show already some interesting data also at the end of last year. At that time point, Q4, we had 11 patients and 3 dose cohorts that have been treated. And out of those 11 patients, we already saw 2 positive responses observed in 2 patients, which is quite interesting because, first of all, you have to keep in mind, this is not liquid tumor, this is solid tumors. And then normally, you would expect that you need a little bit more time in order to develop responses. We were actually quite positively surprised to see that, that early. And then on the bottom of the slide, you see what is next. So obviously, we'll continue with dose escalation. The next cohort, as written here, is the 2-milligram per kilogram cohort. And then hopefully, towards the end of this year determine the recommended Phase II dose and then move into those expansions. So also this, I think, is obviously early days in this study, but I think we're quite happy about the positive responses that we have seen. Then on BI-1808, which is the third kit in line, so to speak, on the block. So as you remember, there, we have very strong preclinical validation as a single agent, but also in combination with pembrolizumab. Based on that, we kicked off a clinical trial early last year, and we're currently running the single agent arm of the study, which is BI-1808 as a single agent, and we are well into the dose escalation phase, and we hope to provide updates on the study by mid this year. And once we move into dose expansion, then we move into non small cell lung cancer, ovarian cancer and CTCL, which is a rare T-cell lymphoma. We'll also start dose escalation for the combination part with pembrolizumab soon during the first half of this year, and that will be a little bit smaller dose escalations since we already have the single agent dose escalation. And once that is done, we move them also in the combination arm into non-small cell lung cancer and ovarian cancer. And this is also done under clinical supply and collaboration agreement with Merck. Then we had also very strong data -- preclinical data. And I mentioned at the beginning that we had a very nice scientific publication about BT-001 proof-of-concept publication preclinically. And since we have a very strong preclinical validation, we also started clinical development early last year for this program, obviously, under the 50-50 joint venture with Transgene. And we're currently in Part A, where we test single-agent BT-001 into tumor, and we're also planning to give an update during the first half of this year on that part. Once we have done Part A, we move into Part B, where we combine BT-001 with pembrolizumab and then Phase IIa would be then focusing on several cohorts with different tumor types. Also this study is running very well as is BI-1808. That leads me to the financial overview, and I hand over to Stefan.

Thank you, Martin. I will present the financial overview for Q4 and the 12-month period, January to December. All amounts are in SEK million, unless I say something else. The net sales were SEK 4.9 million in Q4 2021 compared to SEK 98.7 million in Q4 2020, that's SEK 94 million lower. The decrease is mainly related to that in Q4 2020, we received an upfront payment of $5 million from CASI Pharmaceuticals and a $3 million milestone from Pfizer and a EUR 2 million milestone on Daiichi Bank. These 3 payments corresponded to in total SEK 91 million. Net sales for January, December 2021 was SEK 19.4 million. For the same period in 2020, net sales were SEK 147.4 million, and that's a decrease of SEK 128 million. And the decrease is related to the just mentioned prepayments were seen in Q4 2020, but also that the revenues from production of antibodies for customers was roughly SEK 31 million lower than in 2020. Also, there was no research funding in 2021, which was SEK 7 million in 2020. And on cost side, in Q4, operating costs increased from SEK 69.3 million in Q4 2020 to SEK 83.8 million in Q4 2021, that's an increase of SEK 15 million. We had mainly higher cost in BI-1206 and BI-1607. There was mainly lower cost in BI-1808. We also had higher personnel cost. For January to December, the increase of operating cost was SEK 75 million from SEK 222.8 million in 2020 to SEK 297.7 million in 2021, which included a onetime payment of GBP 2.5 million or SEK 28 million to CRUK in exchange for reduce in BioInvent's obligation to them regarding BI-1206. During the period, we had significantly higher cost in BI-1206 due to the just mentioned payment to CRUK, but also to increase cost of [ just for the cancer ] study in '20. We had also higher costs in mainly BI-1607 and BI-1910, and we had quite low cost of production of antibodies for customers. And finally, personnel cost was quite higher compared to 2020. The loss for Q4 2021 was minus SEK 78.8 million and the loss for January, December 2021 was minus SEK 278.4 million. And the share issue completed in March 2021 amounted to SEK 962 million before issue expenses. And liquid funds, current and long-term investments end of December amounted to SEK 1.365 billion. And yes, that was my color for period. Over to you, Martin.

Thank you, Stefan. And that would lead me probably to, not my last slide yet, but almost. So on this slide, you will see a summary of the upcoming key catalysts. And I'll just summarize them once more. So I think I mentioned it already during the presentation. So for BI-1206, our lead program in combination with rituximab. So as I said, so we are about to select the dose for Part 2 in non-Hodgkin lymphoma and then initiate the Phase II part of the study. And then, as I also already mentioned, we'll start to include Chinese patients into the worldwide clinical development of BI-1206 for non-Hodgkin lymphoma. So that should happen during the first half of this year. Then BI-1808, our antigen receptor 2 program. There, we will present initial Phase I clinical data by mid this year. Just to remind you, so BI-1808 is really one of the very interesting programs in that sense that TNF receptor 2 might be one of the new and upcoming immuno-oncology targets, and we are clearly leading the pack and would be the first company bringing our clinical data on that very exciting target. BT-001, this is our 50-50 joint venture with Transgene during which we combined our anti-CTLA-4 antibody, our proprietary anti-CTLA-4 antibody with the oncolytic virus platform of Transgene. And there, we also will present initial Phase I clinical data during the first half of this year. And then last but not least, BI-1607, which is our second anti Fc gamma RIIB and our fifth clinical program that we will start during the first half of this year. In addition, we might see potential additional milestones from collaborations and maybe potentially also additional partnerships. Thank you very much for your attention, and then we would be happy to receive questions. Thank you very much.

[Operator Instructions] Our first question comes from the line of Richard Ramanius from Redeye.

So first, scientific questions concerning BI-1206. Have you seen any correlation between those and response in lymphoma?

Yes. Thank you, Richard. Absolutely. I think we could clearly demonstrate we did that also during our KOL event that we see, of course, more responses in the higher doses as we have shown actually during the KOL event.

Okay. Perhaps this is a speculative question, but one of your complete responses is nearing 3 years, so that's close to remission or in popular words, cure. How common is that in this indication? And do you see any potential of BI-1206 leading to complete responses?

Yes. I think that's a very good question. Thank you, Richard. So obviously, this is a very high-quality complete response, something that you probably would see not so often. And basically, that means that, that patient, since 2 years, not receiving any treatment and is selling complete response, and you could even call that remission or cure. But obviously, you never know, there might be a relapse at a later time point, nevertheless. But I think whatever it is, it's a very high-quality, long-lasting complete response, something that you see very, very rarely. And I think what I didn't explain during the presentation, so with BI-1206 currently, we are focusing on second and third line of patients who do not respond anymore to anti-CD20-based treatment, in this case, rituximab. And I think what is quite interesting is it became very obvious when we had our KOL events, we were joined by Professor Michael Wang from the MD Anderson Cancer Center. One of the leading experts for mantle cell lymphoma, but also follicular lymphoma. And these new anti-CD20-based treatments remain central, even given the new approaches with, for instance, CAR T or bispecific antibodies. And if you have something that could reinitiate or reinvigorate, whatever you want to call it, the response to anti-CD20-based treatment, that would be very preferred. And if you can do that in a safe and tolerable manner, that will be even perfect. So I think what I'm trying to say is that even though we are currently developing BI-1206 for second and third line, I think there's also good potential for first line, especially when you see these high-quality responses.

And then I had -- I thought about your new subcutaneous formulation. So how is the path? How does it post approval look for that project? Will you have to do -- develop it through Phase I and onwards? And how does the patent situation look like?

Yes. First of all, I think this is very, very good news because, as you know, so we are controlling the infusion-related reaction that we have seen with historic steroid treatment, which works very well. But we might be able to do even better with subcutaneous, then we would not need steroid treatments anymore. The other thing is, of course, it's a very convenient application because infusions, we have to go to a center for this. If you do subcu applications, it's much, much easier. You don't have to go to a transfusion center. And the thing that we have everything under one roof, that means that we have the capability to do our own subcutaneous formulation, I think, was also quite helpful because we made the decision early last year, and now we already have a product ready to be tested in the clinic by second half of this year, which is very, very quick. And basically, that's what we're going to do. So we'll treat it in parallel as we move ahead with the infusion-based application of BI-1206 and we will also discuss its quality maybe not at this stage, but a little bit later with the FDA. But our idea currently is that we move it in parallel. And based on the patient [ yearly ] experiments that we have done so far, we believe it will work very well. And then once we have shown that it works, then it can be basically joined with the other development stream. So we have to run it at the beginning in parallel and then it will join later the main development stream.

Okay. And how does the patent situation look like as compared to the infusion version?

Absolutely. So obviously, since it's a new formulation, we also have the chance to put additional IP around this product as well.

Okay. Then I had 2 financial questions. Costs, I saw increase slightly in 2022, where we see any increases in costs during full year 2023 compared to 2022? And can you comment anything about size of milestones or potential milestones during '20 -- sorry, I mean, cost in 2022, if you can comment on that? And potential size of milestones in 2022?

Stefan, do you want to address that?

Yes, sure. First question around guidance for R&D costs in 2022. We don't give that. We can see that we are having more programs in the clinic. So that would increase. Of course, we don't give exact figures. But what we can say is that based on current staff, we foresee to have financing until end of 2024. And that cash run could be extended somewhat if we get upfronts from new collaborations or if we get the milestones. Regarding milestones, we don't give guidance for that.

Our next question comes from the line of Sebastiaan van der Schoot from Kempen.

I just have 3 questions from my side. The first one is on 1206 in non-Hodgkin's lymphoma. Can you clarify whether during the dose expansion part of the study that it can also be leveraged for patient recruitment?

So obviously, we don't give any further updates on the second part because we want to wait first the end of Phase I meeting with the FDA. Once that is in place and we have the response of the FDA, we will update the market with the specific details on the Part 2 of the study.

Okay. Great. And then the second question is on announcing the complete dose escalation data. Will that also be happening after the end of Phase I meeting? And will you give a complete update on total data sets? And what's the next plans are? Or a go or no go for a potential physical trial in follicular lymphoma? Or what is your current thinking on that?

Well, our current thinking is, in any case, to provide an update from the feedback of the FDA which, of course, will also include the data of the first half because that will then obviously -- or the view of the FDA of the data of the first part will influence what we hopefully can do in the second part. And as I said, so our hope is obviously that we kick off with a pivotal study. So we will have -- we'll provide a comprehensive overview once we have the feedback of the FDA.

Okay. Great. And then on 1808, you already mentioned that you are pretty far, and dose escalation is going well. Can you maybe comment on what type of data can we expect? Do we already expect single-agent activity with this drug? Or is that more something that we should wait for with combination with pembrolizumab? And is there may be other data that we can look forward to maybe better market data or something similar?

Yes. So I think it will be a mix of everything. Obviously, again, data driven, and I cannot mention anything here yet at the moment. But what we are thinking is that at the time we get out, yes, we will give, obviously, a summary on safety. We'll talk about certain markers, hopefully, and then hopefully also about clinical science. But as I said, so that will be data driven, but our view is that we will give a comprehensive overview during the first half or roughly about the first half of this year.

Okay. Great. And then just one question on your collaboration with Skyline Therapeutics. Is that only on the non-Hodgkin lymphoma program? Or is -- much more? And does it also go beyond Fc gamma receptor IIB?

So currently, it's focused on Fc gamma RIIB, which is the non-Hodgkin lymphoma as well as the solid cancer.

Our next question comes from the line of Joseph Hedden from Rx Securities.

Just wondered if we could get update on the Pfizer collaboration...

Apologies, Joseph, if you could please speak up. I don't think you're audible for the speakers currently. [Technical Difficulty]

Now?

Yes, that's much better, Joseph.

Sorry about that. I just wondered, Martin, if we could get an update on what's happening under the Pfizer collaboration? And perhaps thoughts for this year more near-term expectations?

Yes. So just to remind everybody, so with Pfizer, we moved into a different part of the collaboration during last year. So the program was focused on generating interesting targets in antibodies for tumor-associated myeloid cells and tumor-associated myeloid cells are probably one of the most important cell types in the tumor microenvironment. And we have discovered quite a number of targets and antibodies. Pfizer made their picks regarding targets and antibodies and move that into their internal development. So there is no active contribution at the moment from our side. We do not disclose how the whole collaboration is structured. Obviously, as you might remember, there was an upfront and there were certain FTE collaborations and certain milestones during the discovery phase, and we have the same, obviously, during the development phase, but we didn't disclose anything, and that is also based on doing this in discussions that we have with Pfizer. So it's what I can say. It's in development with Pfizer. And as Stefan already said, so obviously, we have also antibodies in development with other companies such as Daiichi, Mitsubishi, Takeda, Bayer and so forth. And we don't give any outlook when we hit certain milestones. When they happen, we will disclose it to the public. But what I can say is that Pfizer was very keen to move ahead with that programs or the target and the antibodies that they have picked. And as they hit milestones, then we will announce that to the market. What I can say in addition, obviously, we did a very broad screening on tumor-associated myeloid cells. So as I said, so we actually discovered a high number of interesting targets in antibodies. So there's quite a number with us that we could consider for further partnering or for our own development, basically.

Our final question comes from the line of Sebastiaan van der Schoot from Kempen.

Just one more question regarding 1607. When are you going to update the markets on the indication that you're going to apply the new commercial antibody in and which combination?

Yes. So that will be, and Stefan, please help me there, so we will have abstracts at AACR at this one, covering 1607, and that will basically then give you a little bit more of granularity and that will be probably the next time when we talk more about 1607, as I explained already earlier. So we have been quite secretive about it because we are still filing IP, which we have done by that time point. And then, of course, we can disclose more details.

At this stage, we have no further questions. I'll hand back to the speakers for any final remarks.

Thank you very much, everybody, for attending. And I think that was actually a quite exciting Q4. We delivered all the milestones that we promised. And I think even a little bit in addition. And yes, stay tuned. I think this year will be quite exciting and interesting as well, probably even a little bit more than last year since we now have 4 active programs that will deliver milestones, as I already described during the presentation. So I think me and the team remain very excited what is lying ahead of us. And hopefully, it will be very successful. Thank you very much.

This now concludes the presentation. Thank you all for attending. You may now disconnect your lines.