BerGenBio 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.

And 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?

So the question was about the next steps and the strategic review. So that's 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. So if that's licensing, if it's an acquisition, reverse merger, etc. So that's a process that we will be going through together with the banks that will help us in this process. There's 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. So you will be informed through that process.

Any specific discussion with potential partners?

I can comment on any specific discussions at the moment. Now this news is quite new, so I expect to get some phone calls.

Can you give more details about timeline about this strategic revolution?

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 two 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 of the 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. um and then it's a question about efficacy data what exactly does that mean for this pre this readout yesterday so yeah what does the efficacy data mean uh the it it means so maybe you know to kind of one step back um this is first line therapy and they're already um 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 bemsentamib 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 doesn't mean that we really reducing the efficacy it just means that you know that's basically a chance statistical chance why we're lower but there's no really signs that we're adding anything and if you're not adding anything then we're not going to be used in that setting have you any guidance on the financial runway following this closure of the study So 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 there should be no surprise to you that we haven't really planned for closing. So that work is starting now. And it's very difficult to give a 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.

And then it's a question about a recent Chinese report that suggested bamsentamine 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. So it's not work that we have been involved with. I guess it's important to point out it's preclinical. study that came it's of course it could be interesting if Axel inhibition is useful in CNS disease and I think Bem was highlighted as the best Axel inhibitor because of being the most selective one that's something that we're not surprised that they say that because that's So that is definitely one of the advantages of BEM, the high selectivity. But 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's anything there that can be interesting for others.

And then it's 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 is an investigator-led study. So that means that Bergen Bayer 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, you know, 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. You know, it's second line lung cancer. So it's, you know, it's not first line. And it is in combination with SOBIS-JAK inhibitor pacritinib. So, you know, it will provide a different data set. um so yeah we we will support that study going forward and and again that will be one of the assets of the company that we will look into and then a question about partner discussion previously partner discussions and a specific thing we can share from that i don't think there's anything we can share on you know partner discussions um as you know they they The only right time to really share partner discussions is when you have a contract signed and not before. So, yeah, I think there's not much to say on that.

And obviously, the recent discussion have been about the stick 11 indication and nothing else in a way.

So that's probably it.

The unmet medical need in patients with difficult to treat mutations like STK11 is still there. We have not shown that we can solve it today, but there is definitely interest around that mutation and axial 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, I'm 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. And when I was asked to join the company, I knew that Bergen Bayer was very much a binary company. outcome. And I knew it was a relatively short term binary outcome. So I walked into that with open eyes. I do like I do like excellent 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 Ola. Thank you Rune and thank you everyone for your interest and that concludes our presentation today. Thank you.