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

Thank you very much, and welcome, everybody, to our call today. It's the interim report January to September 2023. And -- and I am 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 [ IIa] trial of single-agent BI-1808 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 USD 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 2 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 targeted receptor 2. And then we'll have also some preclinical data sets on BI-1910, which is a second candidate. So 1808, just to remind you, is blocking deleting antibody while 1910 is an agonistic antibody. Then also will present our dose escalation part of the BI-1607, which is our second anti-Fc gamma receptor IIB 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 patients have 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 5 clinical programs running. And we are focusing more or less on 3 targets. So we have our platforms around Fc gamma receptor IIB and TNF receptor 2. And you see that on both platforms, we have different assets for Fc gamma receptor IIB, we've our lead 1206, currently in 2 clinical trials, but then we also have a second anti-Fc gamma receptor IIB antibody, which is 1607. And that's the data set that will come out later this year. Then on our TNF receptor 2 platform, which is actually quite interesting targets. And when we started, we were almost alone, now Novartis is working on TNF receptor 2 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 a leading antibody, there's 1808 that we're currently testing as a single agent as well as in combination with pembrolizumab. And then I mentioned 1910. This is an agonist antibodies. And both antibodies will be covered [ at SITC ] 1808 as a single agent and 1910 preclinical data. And we hopefully then also will initiate the clinical development around 1910 soon. And then I mentioned already, there's BT-001, now in combination with pembrolizumab. And this is based on our proprietary anti-CTLA4 antibody, which is nicely differentiated from ipilimumab and we run it in combination with the Oncologic biospectrum of Transgene and that has also moved now into the combination of -- with pembro. What I will do now in the next slides is basically go program by program to give you a little bit of highlights of the update and where we are at the moment. So starting then with 1206 in Non-Hodgkin’s 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 the plus 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 the first half of next year. Just to remind you, the data from the IV dose escalation interim results were quite strong. So we had 4 complete responses, 3 partial responses and 4 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 3 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, which 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 1206 in 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 in 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 2 long-lasting partial responses and 2 patients with a stable disease out of a total of 18 evaluable patients. And I think what is important to remind everybody is that both patients have seen at least 2, sometimes 3 lines of either anti-PD-1 or anti-PD-L-1 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-Fc gamma receptor IIB antibody, which is BI-1607, which is running currently in combination with trastuzumab for HER plus solid cancer indications. So the dose escalation part of the study has been completed without any safety concerns. We saw the PK profile are 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 data set will be presented, as you can see on the right-hand side on the San Antonio Breast Cancer Symposium in Texas in December. So this is quite interesting. And 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 the tumor marker environment, but not systemically. So that was quite interesting. And as you know, 1808 is ongoing the 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 IIa 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 data set will be available in the first half of next year. We reported already strong interim safety, and we saw first signs of efficacy, but stable disease observed in 6 patients during the single aged dose escalation parts. And in the Phase IIa single seeking 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 the data set already, but there's some additional data that we want to highlight at SITC, and we're really looking forward to that. And in addition, we will also have the 1910 preclinical data, and that's the next candidate that hopefully wouldn't go into clinical development by the end of this year. So since it is coming up soon, so on November 3, and that's something to mark in the calendar. Then BT-001, now in combination with pembrolizumab start 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 have positive clinical monotherapy interim results, so very good safety data. We saw stabilization of injected lesions in 11 out of 18 patients and saw objective antitumor activity, which is defined as the 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 will be then that we include the last station in the Part B of the Phase I 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 through September 2023. Thank you.

I will present the financial overview for Q3 and the 9-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 a milestone, research milestone. Production of antibodies for customers was SEK 6 million lower in Q3 2023 and research funding as we made in 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 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 for 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 cost in BI-1206. And we had higher personnel costs in Q3 2023. For January to September, the increase of operating cost was SEK 38 million from SEK 277 million to 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 cost for production of antibodies for customers and somewhat lower costs in BI-1607. And personnel costs in 2023 were quite higher compared to 2022. The loss for Q3 2023 was minus SEK 71.1 million, and we had a loss for January to September 2023 of minus SEK 233.1 million. Share issue completed in January 2023 amounted to SEK 31.3 million. Funds, current and long-term investments end of September amounted to a total of SEK 1.358 billion.

Thank you, Stefan. I think that covers the financial part, and I will briefly go over the key catalysts for the remainder of the year. We have just listed the milestones that we view in -- during the second half of this year. And the ones that we already have taken -- I mentioned, but I maybe summarize it again very briefly. So we started our subcu for BI-1206 in combination with Keytruda. And then also, we started our BI-1808, the Phase IIa Part A as a single agent, as I just mentioned. And then we also kicked off the combination study with Keytruda for BT-001. Then what is outstanding for the [indiscernible] is the BI-1808 single-engine data, the data that will be published or presented at SITC, which is coming up in November, 1607, the Phase I data -- dose escalation data sets at the San Antonio Breast Cancer Symposium and then last but not least, to kick off with our clinical trial #6, 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.

[Operator Instructions] The next question comes from Richard Ramanius from Redeye.

I have 3 questions. Start with the accelerated approval pathways. You've previously talked about going to the market more quickly with both BI-1206 and 1808 in smaller niche indications. Is this still the plan? And when do you think there could be on the market, I mean, for both products?

Shall I directly answer that. So this is still an option, Richard, for BI-1206 in non-Hodgkin's lymphoma. As you remember, we have orphan designation for follicular lymphoma as well as for mantle cell lymphoma. And then the option for 1808 is still viable for CTCL, the rare T cell lymphoma. However, and 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 the -- especially around 1808, we have chosen in order really to demonstrate [ single-agent ] to not go after 1 dose expansion cohort, but rather [ 4 ] at least, and then just repeat them, it's ovarian, lung cancer, it's CTCL 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 1 area. And the idea behind that is really to show single-agent activity. That's why we did it.

Okay. So your -- let's say, in short words, you're looking at effect in broader indications, which is interesting for partners.

Exactly. Exactly. Exactly.

Yes. My second question was how is the collaboration going with CASI? They will start in solid cancers as well, is that correct?

So with CASI, first of all, the collaboration is going very well. Obviously, it was hampered by the period when China was on a 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 and liquid cancers. Obviously, they have the right to be 12 or 6 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 [indiscernible] indication, but currently they are focused on liquid cancers.

Okay. And I had a financial question with your large cash position and interest increasing the American rates depending on the term -- 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 -- on this cash position?

As you say, you can get up to -- we place money up to 2 years, and you can get up to 5% currently. And you hold some cash at a lower -- you try to place this as safe as possible, of course, to not taking a risk to this. And we don't -- we have -- when it comes to our holding of currency risks, we try all the time to eliminate cash flow -- currency risk with inflow and outflow of cash in the different currencies.

Okay. Those were my questions.

The next question comes from Dan Akschuti from Pareto Securities.

First one would be just if you could elaborate a bit how the partnership with Exelixis is growing. And as we can see, revenues from the partnerships, are these increasing now? What's your expectation for Q4?