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 Skeie, 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's 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 our forward-looking statements, I am not going to bore you to read that, but I'll flash it here on the screen. What we're here to talk about today is the discontinuation of our first-line STK11 mutated patients with non-small cell lung cancer. The study is called our 016 study, and it's a study of bemcentinib in combination with standard of care therapy in first-line non-small cell lung cancer. We were recruiting other patients with an STK11 mutation, and Keytruda or pembrolizumab plus chemo is the standard of care, so we added BEM on top of that. We were encouraged by the efficacy data in the first study, the phase IB, in a small population, three patients who had that STK11 mutation. That was the reason to go into a phase II study in this population. The review we've done shows lower than expected response rates, and I'll share the data with you in a second. 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. This is the study design, and you've seen this before. The phase IB portion is completed, and now we have started the phase II 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, and those are the 10 that I'm going to share with you in a second. Here we have the data. 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+ patients in stable disease. That's a broader definition that's typically in cancer studies included as a secondary endpoint. You can see why we were encouraged in the phase I portion, the three patients. One had a complete response, two had stable disease. 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 II study. We did not have any patients with complete or partial response. We had three patients with stable disease. A disease control rate, you say 30%, that's okay-ish, but pretty far below the benchmark still. The benchmark I'm showing you here, there are different ones we can use, but this is the Skoulidis paper that I shared with you last time we spoke, and that's really real-world data. What it shows is that without adding bemcentinib, we should have expected maybe a third of patients to have a partial or complete response, and we should expect maybe two-thirds of patients to have disease control. As you can see, if you look at phase II alone or the combination with the phase 1, we're pretty far below that benchmark. Don't forget, what we really need 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 kinds of data in order to make decisions about going forward. 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. We would have to be extremely lucky with the next 10 patients or so in order to kind of correct these numbers. We think that is the rationale for stopping at this point. That leads us into what else do we have in terms of assets. Bemcentinib, we have been working for a while with BEM, and there are other indications 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 are no other opportunities in the dataset. We are 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. 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. We have data on AML. We also have data on second-line lung cancer, and we have an investigator-sponsored study, Taverna study, ongoing in second-line lung cancer in combination with Sobi's JAK inhibitor. I'm going to go to the financials. The year in cash, so end of December, is NOK 140 million. That is slightly above guidance. The operating loss, I think our guidance was NOK 40 million a quarter, so about NOK 160 million, and the real number, so the actual was NOK 151 million, so we're slightly below guidance on operating costs and operating loss. Yeah, the financials are very much in line with what you should have expected. 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 016 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. 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, obviously now it's a very different situation. This will include a lot of negotiations with vendors, etc., about how we can get the cash burn down to minimal while we're going through this strategic review. 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 BGB016 study? Yeah, 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 we should go out and ask for fundraising, ask for more cash to complete the study. 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. That was the reason to stop it. We don't believe that this study would be successful if we continued it. About the next step for the company, you are talking about initiating an exploration of strategic alternatives. Can you give more details about the process? Yeah, so the question was about the next steps and the strategic review. That is really just starting now. We will work with partners and the board about exactly how to do that. Part of it is to look at the assets that we have, and then we will obviously talk to potential partners who are interested in the assets anyway. If that is licensing, if it is an acquisition, reverse merger, etc., etc. That is a process that we will be going through together with the banks that will help us in this process. There is probably a lot of regulation around this from the Oslo Stock Exchange as well that we need to comply with very carefully, and there will be a communication process that is very much regulated. You will be informed through that process. Any specific discussion with potential partners? I can't comment on any specific discussions at the moment. Now, this news is quite new, so I expect to get some phone calls. Yeah. Can you give more details about the timeline about this strategic review? I haven't had a discussion with the board about the timelines, nor with the banks. This is obviously so new that we haven't had those conversations yet, so I think the answer is I don't know yet. Why have you only recruited 10 patients in the phase II part of the study? Yeah, I mean, we recruited 16 to get to 10, so we probably had a little bit more dropouts and people who didn't go to all the scans as we hoped for. I would love to have 20 patients, but I think 10 is enough to make this decision. If we'd been a lot closer to the benchmarks after 10, it would be a much more uncomfortable time, but I think we're so far away from the benchmarks with the first 10 patients that it's very unlikely that we would be able to catch up in the next cohorts. It's a question about the efficacy data. What exactly does that mean for this readout yesterday? Yeah, what does the efficacy data mean? To kind of one step back, this is first-line therapy, and there are already medicines approved and available in first-line therapy in non-small cell lung cancer. It is a very tough disease, and also being able to add to the efficacy there would be amazing. What the data shows is that adding bemcentinib to standard of care is not adding any efficacy. It actually is far below the efficacy that you would expect from standard of care. That does not mean that we are really reducing the efficacy. It just means that that is basically a chance, statistical chance, why we are lower, but there are no really signs that we are adding anything. If we are not adding anything, then we are not going to be used in that setting. Have you any guidance on the financial runway following this closure of the study? Obviously cash burn is going to be extremely important going forward, and I know people will ask about how much is the free cash, how much of the cash will we be using on the closing activities, and it should be no surprise to you that we haven't really planned for closing. That work is starting now, and it's very difficult to give guidance on the closing costs, so I'm not going to do that at this juncture. Is there a risk that the company may shut down? An orderly closure with a redistribution of remaining cash to shareholders is one of the options that we will look at in the strategic review. It's probably not our favorite one, but if that turns out to be the best one for shareholders, that's the one we will do. It is a question about a recent Chinese report that suggested bemcentinib for treatment of Parkinson's patients. Can you say anything about that? Yeah, the first time I heard about BEM in Parkinson's was on Friday, just like you. It's not work that we have been involved with. I guess it's important to point out it's a preclinical study that came. It's, of course, could be interesting if AXL inhibition is useful in CNS disease. I think BEM was highlighted as the best AXL inhibitor because of being the most selective one. That's something that we're not surprised that they say that because that is definitely one of the advantages of BEM, the high selectivity. I think we highlight that this is early stuff, and we will definitely throw it into our strategic review when we look at assets to see if there is anything there that can be interesting for others. It is an ongoing study also in lung cancer with Dr. Taverna, the 025 study. Can you give any updates on that? Yeah, so the Taverna study, it's an investigator-led study, so that means that BerGenBio is not the sponsor of the study. So our involvement is really to provide drug, so we support the study that way. Our plan is to continue to do that, and obviously part of our review now is to make sure that we can do that and look at the implications in terms of cost and manufacturing, etc. But our intention is to continue to supply that study. It's second-line lung cancer, so it's not first-line, and it is in combination with Sobi's JAK inhibitor, pacritinib, so it will provide a different dataset. So yeah, we will support that study going forward, and again, that will be one of the assets of the company that we will look into. A question about partner discussion, previously partner discussions. Any specific thing we can share from that? I don't think there's anything we can share on partner discussions. As you know, the only right time to really share partner discussions is when you have a contract signed and not before. Yeah, I think there's not much to say on that. Obviously, the recent discussion has been about the STK11 indication and nothing else in a way, so that's probably fair to say. Yeah, the unmet medical need in patients with difficult-to-treat mutations like STK11 is still there, and we have not shown that we could solve it today, but there is definitely interest around that mutation, and AXL inhibition is still a legitimate target and mechanism of action in cancer and beyond. It's a question about the CEO change. Anything you can share about that in this view? I mean, obviously, I haven't been there that long, so I arrived in November. I don't know the rationale of the previous CEO to leave. I can note that he has a new job, so that's all I know really. When I was asked to join the company, I knew that BerGenBio was very much a binary outcome, and I knew it was a relatively short-term binary outcome, so I walked into that with open eyes. I do like AXL inhibition. I think that is a legitimate target, as I mentioned before. I do also think that non-small cell lung cancer, while a difficult condition to treat, is a huge unmet medical need, so if we can show something there, it's important, and those are the reasons why I joined the company. I think that completes the Q&A. Thank you, Olav. Thank you, Rune, and thank you, everyone, for your interest, and that concludes our presentation today. Thank you.