Welcome to the BioInvent Q3 2023 report. 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. Now, I will hand the conference over to the speakers, CEO Martin Welschof and CFO Stefan Ericsson. Please go ahead.
Thank you very much, and welcome everybody to our call today. It's the interim report, January to September 2023. I'm Martin Welschof, the CEO, and I will start the presentation, and later the second part of the presentation will be covered by Stefan Ericsson, our CFO. So I would start with a quick summary of the interim report. So briefly go over the events in the third quarter. So we had the first patient recruited into our phase I trial of single-agent BI-1 808 for the treatment of advanced malignancies, and that was a very important milestone for the company, and I will come back to that later in a little bit more detail. Then we also initiated the subcutaneous arm of our phase I/II clinical trial for solid tumors for BI- 1206 in combination with pembrolizumab.
Then on the collaboration side, as you probably will remember, we're quite active on that as well. So we signed an agreement with Exelixis and actually achieved the first research milestone, which was triggering a $1 million milestone payment, which of course is not super significant, but I think it's a good sign for the activity that we have in that collaboration. Then we're really looking forward to two poster presentations to be held at SITC in November this year. The first one will be on the single-agent phase I data for BI-1808, which is our lead candidate targeting TNF receptor 2. And then we'll have also some preclinical data sets on BI-1910, which is the second candidate. So 1808, just to remind you, is a blocking, depleting antibody, while 1910 is an agonistic antibody.
Then also, we'll present our dose escalation part of the BI-1607, which is our second anti-FcγRIIB antibody, that has been completed without any safety concerns, and the first clinical data set from that will be presented on the San Antonio Breast Cancer Symposium in December. Then there was one event after the end of the period, which was also an important milestone. So you remember our anti-CTLA-4 BT-001 compound, clinical development that we run in collaboration with Transgene. It's a 50/50 joint venture. And there we announced that the first patient had been treated now in the Part B of the phase I study, where we combine it with KEYTRUDA. So just to remind you that we have a portfolio strategy. I'll just show that slide again.
So you see that we have a quite interesting portfolio, currently five clinical programs running. We're focusing more or less on three targets. So we have our platforms around FcγRIIB and TNF receptor two. And you see that on both platforms, we have different assets. For FcγRIIB, we have our lead 1206, currently in two clinical trials, but then we also have a second anti-FcγRIIB antibody, which is 1607, and that's the data set that will come out later this year. Then on our TNF receptor two platform, which actually quite interesting target, and when we started, we were almost alone. Now, Novartis is working on the TNF receptor two program, BeiGene, and then a couple of other companies.
But we are still in the lead, and we feel probably one year ahead of the competition. And the leading antibody, there's BI-1808, that we're currently testing as a single agent, as well as in combination with pembrolizumab. And then I mentioned BI-1910. This is an agonistic antibody, and both antibodies will be covered at SITC, BI-1808 as a single agent and BI-1910 preclinical data. And we hopefully then also will initiate the clinical development around BI-1910 soon. And then I mentioned already, there's BT-001 now in combination with pembrolizumab, and this is based on our proprietary anti-CTLA-4 antibody, which is nicely differentiated from ipilimumab. And we run it in combination with the oncolytic virus platform of Transgene, and that has also moved now into the combination with pembro.
What I will do now in the next slides is basically go program by program to give you a little, little bit of highlight of the update and where we are at the moment. So starting then with 1206 in non-Hodgkin lymphoma in combination with rituximab. So as you will remember, we are currently developing a subcutaneous formulation as well as an IV. And the recruitment for the subcutaneous as well as for the IV is still ongoing. And regarding the subcu, I can say that we have reached now 150 milligrams safely, and we are collecting further data, and we want to have a significant data set, not just you know the +5 normal patient that you would like to show or we would like to have.
That's why we've decided to run it a little bit longer before we disclose the data, which will be then first half of next year. Just to remind you, the data from the IV dose escalation interim results were quite strong. So we had four complete responses, three partial responses, and four cases of stable disease. And I think the update here is really that the complete responses are still lasting. So as of June, the median duration of the complete response was 2.5 years, with three patients ongoing. The fourth patient, we basically lost, not lost to disease, but we lost him or her because they are not reporting back anymore.
But those ones that we're still connected with, we see that the complete response is still long-lasting, and this is quite remarkable. So the next steps here will be the first phase I results from the subcu, which is now scheduled for the first half of 2024. Switching then to BI-1607 combination with pembrolizumab. So this is still at earlier stages, still in dose escalation, but also here we have started now the combination with the subcu. And the first patient was recruited to the subcutaneous arm of the study in September. We have actually quite some positive interim results, so we saw early signs of efficacy. So we have two long-lasting partial responses, and two patients with stable disease out of a total of 18 available patients.
I think what is important to remind everybody is that those patients have seen at least two, sometimes three lines of either anti-PD-1 or anti-PD-L1 containing regimens and do not respond anymore. So it's a big deal that we see responses. And both responding patients have melanoma, and both have been previously treated with immune checkpoint inhibitors, as I already mentioned. So the next steps here will be that we extend the efficacy signal in the key indications, melanoma, and then determine the dose for the part 2. Now, moving then to our second anti-FcγRIIB antibody, which is BI-1607, which is running currently in combination with trastuzumab for HER2-positive solid cancers, indications. So the dose escalation part of the study has been completed without any safety concerns.
We saw the PK profile, as predicted, had adequate exposure and full receptor occupancy during the full treatment interval, and the exploratory work at intermediate dose level is now being conducted to determine the best dose to move forward in subsequent studies. The dataset will be presented, as you can see here on the right-hand side, on the San Antonio Breast Cancer Symposium in Texas in December. So this is quite interesting. Then moving to TNF receptor 2, and as I already mentioned on my introductory part, TNF receptor 2 is a very interesting target, and that might be another checkpoint, and then obviously, 1808 would be another checkpoint inhibitor. When we started that study, we're quite... there was only one other group in Boston, academic group, that then turned into a company.
And we actually found TNF receptor 2 upregulated on material from ovarian cancer patients, and it was upregulated only in tumor microenvironment, but not systemically, so that was quite interesting. And as you know, 1808 is ongoing in development since quite a while, and we have finished now the phase I part, the dose escalation part for 1808 single agent. And we actually moved now into the phase II-A part, which we did in September, when we recruited the first patients. The dose escalation for 1808 in combination with pembro is also ongoing since September 2022, and that dataset will be available first half of next year.
We reported already strong interim safety, and we saw, you know, first signs of efficacy with stable disease observed in six patients during the single-agent dose escalation part. In the phase II-A single-agent expansion cohorts, we plan to include lung cancer, ovarian cancer, melanoma, and T-cell lymphoma. So it actually will be quite broad because our goal is really here to establish a single-agent activity. So what is next is then the single-agent data that will be presented at SITC, and obviously, we had a press release on that dataset already, but there's some additional data that we want to highlight at SITC, and we're really looking forward to that.
In addition, we will also have the 1910 preclinical data, and that's the next candidate that hopefully will go into clinical development by the end of this year. So SITC is coming up soon, so we're on November 3rd, and that's something to mark in the calendar. Then BT-001 now in combination with pembrolizumab. So in October 2023, we announced, we and Transgene announced the first patient dose in the phase I, part B, where we then evaluate and analyze BT-001 in combination with KEYTRUDA. We had positive clinical immunotherapy interim results, so very good safety data. We saw stabilization of injected lesions in 11 out of 18 patients, and saw objective anti-tumor activity, which is defined as a decrease of injected lesion size of 50% or more.
So that was quite promising, and of course, now we're moving into the combination to see how it will look there. So the next step that will be done, that we include the last patient in the part B of the phase one study evaluating the combination of BT-001 and KEYTRUDA, and that should happen during the first half of next year. That's, I think, the quick summary that I wanted to provide, and now I would like to hand over to Stefan in order to cover the financial overview, January to September 2023.
Thank you. I will present the financial overview for Q3 and the nine-month period, January to September. All amounts are in SEK million, unless otherwise mentioned. Net sales were SEK 26.8 million in Q3 2023, compared to SEK 17.9 million in Q3 2022. That's SEK 9 million higher in Q3 2023. The increase is related to the $1 million milestone that we received from Exelixis when we reached the milestone, research milestone. Production of antibodies for customers was SEK 6 million lower in Q3 2023, and research funding was SEK 3 million higher in Q3 2023. Net sales for January to September 2023 were SEK 56.1 million. For the same period in 2022, net sales were SEK 305.5 million. That's a decrease of SEK 249 million.
The decrease is related to that we, in 2022, received an upfront payment of $25 million, corresponding to SEK 256 million when we signed an agreement with Exelixis. In 2022, we also received a EUR 0.5 million milestone from Bayer. The decrease is also related to that revenue for production of antibodies for customers was SEK 21 million lower in 2023. Positive deviations in 2023 were that research funding was SEK 22 million higher, and that we, in 2023, received a $1 million milestone from Exelixis. Operating costs increased from SEK 87.1 million in Q3 2022 to SEK 108.1 million in Q3 2023. That's an increase of SEK 21 million .
We had quite higher costs in BI-1607 and BI-1808, and somewhat higher costs in BI-1206, and we had higher personnel costs in Q3 2023. For January to September, the increase of operating costs was SEK 38 million, from SEK 277 million-SEK 315 million in 2023. During the period, we had quite higher costs in BI-1206 and BI-1808. We also had somewhat higher costs in BI-1910. We had quite lower costs for production of antibodies for customers and somewhat lower costs in BI-1607. Personnel costs in 2023 were quite higher compared to 2022. The loss for Q3 2023 was -SEK 71.1 million, and we had a loss for January to September 2023 of -SEK 233.1 million.
Share issue completed in January 2023 amounted to SEK 31.3 million. Liquid funds, current and long-term investments, end of September, amounted to in total SEK 1,358 million.
Thank you, Stefan. I think that covers the financial part. And at the end, I will briefly go over the key catalysts for the remainder of the year. We have just listed the milestones here that were due in during the second half of this year. And the ones that we already have ticked off, I mentioned, but I'll maybe summarize it again very briefly. We started our sub-Q for BI-1206 in combination with KEYTRUDA. And then also we started our BI-1808, the phase II-A, part A, as a single agent, as just mentioned. And then we also kicked off the combination study with KEYTRUDA for BT-001. And then what is outstanding for this year still is the BI-1808 single agent data.
The data that will be published or presented at SITC, which is coming up in November. 1607, a phase I data, dose escalation data set at the San Antonio Breast Cancer Symposium. And then last but not least, to kick off with our clinical trial number six, which is BI-1910, our second TNF receptor 2 antibody. Yes, so this is the end of the presentation, and now we're happy to take questions.
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 Richard Ramanius from Redeye. Please go ahead.
Hello, good afternoon. I have three questions. Let's start with the accelerated approval pathways. You previously talked about going to the market more quickly with both BI-1206 and BI-1808 in smaller niche indications. Is this still the plan? And when do you think they could be on the market? I mean, for both products?
Shall I directly answer that? So, this is still an option. Hi, Richard. For BI-1206 in non-Hodgkin lymphoma, as you remember, we have orphan designation for follicular lymphoma as well as for mantle cell lymphoma. Then the option for BI-1808 is still viable for CTCL, the rare T-cell lymphoma. However, of course, we have done some planning internally, but I think I would not present those numbers here today. And also, I think what is the however? The however is that the regulatory landscape has changed in that sense that you do have to do much more dose finding, so Project Optimus, that's obviously the main reason for it.
And then, you know, the, especially around BI-1808, we have chosen, in order really to demonstrate single agent activity, to not go after one dose expansion cohort, but rather four at least. And I'll just repeat them. It's ovarian, it's lung cancer, it's CTCL-
Mm-hmm.
and it's melanoma. Because I think it's at the stage where we're in, it's much more important to show broad application potential rather than really focus already now on one area. And the idea behind that is really to show single-agent activity. That's why we did it.
Okay, so, you're saying in short words, you're looking at affecting broader indications, which is interesting for the partners.
Exactly. Exactly. Exactly.
Yeah, my second question was, how is the collaboration going with KAHR Medical? They will do studies in solid cancers as well. Is that correct?
So with KAHR, first of all, the collaboration is going very well. Obviously, it was hampered by the period when China was under complete lockdown during the pandemic, COVID pandemic. But that has changed now, and I think they are picking up nicely. And, obviously, I can't speak for them because they have to decide when they want to get out with data. But they're very important and integral part of our global overall development strategy for BI-1206. And they are currently focusing on non-Hodgkin's lymphoma, that means liquid cancers. Obviously, they have the right to BI-1206 for China, Hong Kong, Macau, and Taiwan for all applications, but the current focus is clearly on liquid cancers.
And I cannot speak for them once they want to also explore other indications, but currently, they're focused on liquid cancers.
Okay, thanks. I had a financial question. With your large cash position and interest rates increasing, the American rates, okay, depending on the term or short-term rates are above 5% now. So, my question is, how much your cash position is in foreign currencies, how much in dollars, and how much interest do you earn on this cash position?
As you say, you can get up to. We place money up to two years, and you can get up to 5% currently. And you hold some cash at the lower, we try to place this as safe as possible, of course, to not take any risk with this. When it comes to our holding of currency risks, we try it all the time to eliminate cash flow currency risk with the inflow and outflow of cash in the different currencies.
Okay. Okay, I understand. Thank... Those were my questions. Thank you.
The next question comes from Dan Akschuti from Pareto Securities. Please go ahead.
Hello, everyone, and thank you for taking my questions. First one would be just if you could elaborate a bit how the partnership with Exelixis is going, and as we can see, revenues from the partnerships are a bit increasing now. What, what's your expectations for Q4? Thank you.
So I'm trying to, you're a little bit muffled, Dan, just to let you know that. But, I think I got what you were asking. So the Exelixis collaboration is going well, as you can see, because we already achieved one milestone, which was rather quick. We don't, you know, it's potentially a broader collaboration, but since it's, you know, very early stage discovery, we don't give any guidance because it could go anywhere. I think we're already happy that they have selected the lead, and there's potential for more. But, I think keep in mind that this is a very early-stage discovery collaboration. We got already $25 million upfront, now we got another $1 million.
We have full FTE coverage, so I think for us, it's a very nice deal in that sense that we also work on assets in case they should not pick them, that we can use ourselves or, you know, partner it otherwise. So I think it's in that sense a very interesting collaboration, but we can't provide any guidance since it's so early because everything can happen at that stage. But it's going well in all in all. I think that was the first part, and the second part, maybe you can repeat that. That was a more financial question, I believe.
Yeah. So if you have any expectations in terms of, like, milestone payments from any partner for Q4?
Yeah, so the only thing what we can say, because, you know, we also cannot provide any guidance regarding this, but you know that we have, I think, six programs currently running with various companies, Daiichi, Mitsubishi, Takeda, Bayer, which are at phase one or phase two. They're all structured the same way. So there was an upfront, and then there are, you know, clinical milestone payments, commercial milestone payments, and then tiered royalties at the end. I think this year we also got from Bayer. Stefan, I'm just looking at you, right? There was a milestone from,
That was last year.
Oh, that was last year. Okay. It's very difficult to forecast since we don't run it by ourselves, but you know, it could be quite interesting, especially that Takeda program. I think it's from my perspective one of the more interesting ones, since they try this asset in multiple clinical studies. We can't give any forecast because they run it at their pace and based on their strategy.
Okay. Thank you very much. The last question would be on you mentioned Novartis and BeiGene are also going after TNFR2, and you're now the first company that has already reported some data. If you could maybe elaborate a bit what we could expect now in this readout. There will be some new data, as I understood, or?
Yes. Yes. There will be some new data because... And of course, I have to do this carefully since it's not released yet, so it will be published at SITC. And it's more kind of related to the fact, maybe you get it from there, not so much that we have much more patients, but what has happened with the patients that have been treated. Keep in mind, they're all late-stage solid cancer patients. In some cases, we had patients that had received 12 different regimens of treatment, you know, all kind of stuff. So that means, once you see a stable disease until it developed into something more, it takes some time. So it's more kind of this type of data that you should expect.
Okay. Thank you. And just a last detail on that, the abstracts for SITC are released on the thirty-first of October. Will that be released and then, or will it be released during the conference?
3. So November 3, it will be released.
Okay. Thank you very much.
You're welcome.
There are no more questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.
I think we can take some questions that I see here that have been sent into the system, and maybe I read it such that everybody gets what has been asked. Question number one: What can you learn from Ultimovacs? You mean BioInvent. Ultimovacs has a SEK 3.5 billion market cap versus our SEK 1.5 billion . I think there's a big difference between Ultimovacs and BioInvent. Ultimovacs is in later stages of clinical development, and when you look at the current market sentiment, that's much more rewarded. I saw most recently a graph from Centerview, looking at immuno-oncology companies that are preclinical or early clinical, and they suffer all the fate.
A lot of them are trading below their money, below the money that they have. And that's not only in Europe, it's also in the U.S., even more pronounced in the U.S. And Ultimovacs, obviously, is a company that is in later stages of clinical development, and when you also look at corporates at the moment, that's where everybody focuses on. So that will change, and we feel that we have data coming already at the end of this year, and then probably even more pronounced during the second half of next year, where we have more late stage, more dose expansion data, and then I think more mature data, that sentiment should change. Then the other question from the same person, which is Bob Bradway, by the way.
Your deal with Exelixis was unexpected, but great news. Can we expect similar stage deals going forward? Yeah, we always have done so, but we have to be also careful because even though, you know, we get a nice upfront and we have FTE coverage, it also takes, people that we normally can use them for, for our personnel, FTE, for internal programs. I think our current thinking is more or less to run one such collaboration at a time. And of course, at, there's always a natural end because, at some time point, candidates will go over to the company, that has, to Exelixis, basically, and then we don't have to do, anything with that anymore.
So once they go into clinical development stage, then we are out, and then we would have again resources to do other such collaborations. But we are, you know, open to it, but not too many at the same time, because the main focus will be still on our own portfolio. And then the last question from Bob was huge deal in the sector a few days ago, Merck versus Daiichi. This is of course in ADCs, antibody conjugated drugs. We don't have any ADCs at the moment, so we're working with naked antibodies. Both have advantages and disadvantages. At the moment, those are kind of in the focus, the new kid on the block, so to speak.
My view is, they have their applications as anything else as well. But you can, in any case, think about, you know, talking about our current portfolio, if we are lucky and we can really, for instance, present single-agent data around BI-1808, I think we can expect similar deals. So I think we can do such deals as well, but we don't... To make it very clear, we don't have ADCs. This is something that we don't do. We only do naked antibodies at the moment. So I think, just scrolling down here to see whether there are any further questions, but no, there aren't any. So I think we have made good progress.
We have a good runway, as Stefan was saying, so, through 2025 into early 2026, depending on current planning, so things can always change. So that we can really work through our portfolio and tick value inflection milestones. And as I said, so the first one where we feel that we have some excitement is the SITC around 1808, and then, going forward, then obviously more maturity during the second half of next year. And I'm quite happy with the development that we've seen throughout the portfolio, and think we are very well-positioned to achieve interesting milestones, as I already mentioned, throughout my presentation. So I'm just looking at Stefan, do you have any final comments?
No.
Nope. So then I thank everybody for the participation, and looking forward to present again at our next, not the next quarterly, but we always do it in half a year, right?
In February.
In February. Yes, exactly. Thank you very much.