Oncoinvent ASA

Good morning. Welcome to the BergenBio Q4 2024 presentation. I'm Olav Hellebø. I'm the CEO of BergenBio. With me in the room, I have Rune Scheie, our CFO as well, who will join me for the Q&A session at the end. The press release that was sent out last night will probably be the bit that is going to be the most pressing thing to discuss today. But formally, this is the Q4 2024 presentation. So we'll do that bit as well. On the next slide here, you can see a forward-looking statement. So I'm not going to bore you to read that, but I'll flash it here on the screen. So what we're here to talk about today is the discontinuation of our first line SDK11 mutated patients with non-small cell lung cancer. So the study is called our O16 study. And it's a study of Bamsentinib in combination with standard care therapy in first line non-small cell lung cancer. And we were recruiting all the patients with the SCK11 mutation. And Keytruda or Pembrolizumab plus chemo is the standard care. So we added them BAM on top of that. We were encouraged by the efficacy data in the first study, the Phase 1b, in a small population, three patients who had that STK11 mutation. So that was the reason to go into a Phase 2 study in this population. And the review we've done shows lower than expected response rate. And I'll share the data with you in a second. But that's what led to yesterday's announcement about the discontinuation of this study. We do not believe that the data is strong enough for us to be able to go out and raise financing in order to complete the study as we had originally planned it. So this is the study design, and you've seen this before. The phase 1b portion is completed, and now we have started the phase 2 study. The original plan is 40 patients to be enrolled in that study. We have enrolled patients that gave us results in 16 patients were enrolled, giving us efficacy results in 10 of them. Those are the 10 that I'm going to share with you in a second. And here we have the data. So ORR is overall response rate, and that was the primary endpoint of this study. That's patients who have either complete response or partial response. DCR, that means disease control rate, and that's the same as ORR plus patients in stable disease. So, you know, that's a broader definition that's typically in cancer studies included as a secondary endpoint. So you can see why we were encouraged in the phase one portion, the three patients. One had a complete response, two had stable disease. So those were encouraging numbers for us to take forward. Unfortunately, we did not see a replication of that in the first 10 patients in the phase two study. We did not have any patients with complete or partial response we have three patients with stable disease so a disease control rate you say 30 percent you know that that's okay ish but pretty far below the benchmark still and the benchmark i'm showing you here the different ones we can use but this is the school leaders paper that i shared with you last time we spoke and that's really real world data and what it shows is that Without adding Bemsantinib, we should have expected maybe a third of patients to have a partial or complete response. And we should expect that maybe two thirds of patients to have disease control. And as you can see, if you look at phase two alone or the combination with the phase one, we're pretty far below that benchmark. And don't forget, what we really needed to do was not to meet the benchmark, but to beat it because we are adding a product on top of the standard of care and the comparison here is standard of care only. It's obviously apples and oranges a bit, but we need to look at these kind of data in order to make decisions about going forward. So yeah, we think we're too far away from where we plan to be. And we don't think it's possible to use this to go out and raise financing to complete the study. And we would have to be extremely lucky with the next 10 patients or so in order to kind of correct these numbers. So we think that is the rationale for stopping at this point. So that leads us into, you know, what else do we have in terms of assets? So BEM Center, we have been working for a while with BEM, and there are other indications. So where we have data, we did decide not to pursue those indications because we felt the biggest opportunity was in first-line non-small cell lung cancer. And that's why we went for that. That doesn't mean that there is no other opportunities in the data set. So we're now doing a strategic review to decide what to do going forward. And a big part of that review is to look at what assets we have. And we're just starting that work right now. But I'm giving you this for you to get a feel for what things we will be looking at. We have excellent data on viral infections. data on AML, we also have data on second-line lung cancer, and we have an investigator-sponsored study, TAIVERNA study, ongoing in second-line lung cancer in combination with SOBE's JAK inhibitor. So I'm going to go to the financials. So the year in cash, so end of December, is 140 million kroners. That is slightly above guidance. The operating loss, I think our guidance was 40 million a quarter, so about 160 million. And the real number, so the actual was 151 million, so we're slightly below guidance on operating costs and operating loss. But yeah, the financials are very much in line with what you should have expected So the next steps for us is, as I already alluded to, to explore the strategic alternatives. Obviously, our goal is to maximize shareholder value. So we will look at mergers, acquisitions, and any way that we can do a transaction that will add value to us. The part of this that we need to do going forward is to close the O16 study. And that's no small task. There are a lot of guidelines and rules from FDA and EMA how you do that. So we need to follow these regulatory guidelines. There are some ethics involved, obviously, that we want to be compliant with as well. But for us, it's all about an orderly closure of the study at the lowest possible cost to preserve cash for the company. And talking about cash, I mean, we'll have a strong focus on cost efficiency and preserving cash going forward. I mean, that's not new. We always do that, but obviously now it's a very different situation. So this will include a lot of negotiations with vendors, et cetera, about how we can get the cash burn down to minimal while we're going through this strategic review process. So with that, I will start taking some of the questions. Rune is receiving questions coming in.

Yes, we have some questions. It might be some of your presentation, but the first question is, why did you decide to close the BGP016 study?

Yes. So, you know, as we said, the study was really designed to read out 40 patients and we always had a plan to have a look somewhere during the study as well. The reason why we did the interim review now after 10 patients is that we needed to make a decision if you should go out and ask for fundraising, ask for more cash to complete the study. And looking at the first 10 patients, we're really too far away from the goals that we had set ourselves where we think that BEM will be a useful addition into first-line non-small cell lung cancer. So that was the reason to stop it. We don't believe that this study would be successful if we continued it.