Alligator Bioscience AB (publ)

So hello and welcome everybody to Alligator Biosciences 2024 year-end report call. My name is Kirjapa Hög. I am the IR and Communications Manager at Alligator and I will be introducing today's call. With me today I have our CEO Søren Reinholt and our CFO Johan Gillius. They will walk you through the latest developments during the previous quarter and 2024 and the upcoming news flow, after which they will be happy to answer any questions you may have. Now, before we start, a quick disclaimer. So during today's call, management may make forward-looking statements that involve known and unknown risks, uncertainties and other important factors beyond the company's control. that could cause the company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. This call is being recorded and webcast and will be made available through the investor relations section of our website. With the formalities out of the way, I would now like to turn it over to Sadam.

Thank you Greta and welcome to Alligator's 2024 end of year call. It's a pleasure seeing so many here with us online. With me, as Grace already said, I have Johan, our CFO, and Johan will get ample opportunity to speak a little bit later in today's session. So let's get started with the next slide, which is basically a table of 2024 in review for Alligator. We have achieved a number of milestones that we have previously communicated that we would obtain and achieve. And we're actually pretty proud that we have delivered on all these promises. So if we start out very early in the year, we announced the top-line data from the Optimize One study early in the quarter 2024. We followed up later in the first half with the first interim data from the phase one study of the molecule we call 527. Those who follow the company knows that that's a molecule we co-developed with the US-based Activo. Just around the middle of the year, we announced very encouraging 18-month survival data from the OPTIMIZE ONE study, and we'll take a glance at those a little bit later. What also happened in the beginning of the year was that FDA had advised Alligator to recruit additional patients in the Optimize I Phase II study on a lower dose of mitocelumab, the 450 microgram dose. We started that recruitment during the first quarter of the year. And very early, already very early in the beginning of the third quarter, we were able to announce that we had now fulfilled the recruitment of that cohort, really a testament to the organization's ability to turn around regulatory advice, turn it into actionable regulatory documents, and getting the trial started and completed. Then in the beginning of this quarter, we announced more promising phase one data from 527, very interesting data at the last dose of the dose escalation trial. a couple of weeks ago we announced the outcome of the first of a set of regulatory interactions with the US FDA and I'll talk more about that in just a second. So all in all a very strong performance by Alligator Bioscience during 2024. And if I could have the next slide. The outstanding phase II results from metacelumab in first-line metastatic pancreatic cancer justifies further investment in the molecule. The next step here is a randomized registrational trial or phase III trial, if you will, in metastatic pancreatic cancer. And we are definitely moving forward with that and we'll talk even more about that in just a second. And we are definitely also engaged in a number of parallel partnering discussions. continue or support the continued growth of the company. We earlier in December announced a rights issue coming up here in February and I'm sure that Johan will take you through a lot of the details there a little bit later. And if I can have the next slide. In connection with that rights issue, we also announced a significant cost reduction program in Alligator. We had to say goodbye to quite a number of employees, all employees concerned with the discovery and preclinical development of antibody drugs. to laser focus the organization on our CD40 targeting antibodies, and particularly mitosalomab, and continue to building value into that program as we develop it towards phase three. It's, of course, important in such a transaction or such an undertaking that you, with surgical precision, try to retain those essential resources that are needed to bring forward metazalumab in this situation. And unfortunately, we were able to do so, so the remaining alligator organization is focused on mitocelumab, is solely focused on mitocelumab, and is fully capable of continuing the path that we have started with the program towards phase three. Can I have the next slide, please? If we look at the pipeline here, just to recapitulate a few messages here. So, Mr. Salomar, on the home stretch of the Phase 2 study, we expect to to announce additional data during Q1, so the 24-month data from the 900-microgram cohort, as well as the top-line data from the 450 data that are important to be able to initiate Phase III. 4066, which we see as the follow-up candidate to mitosalomab, is currently in early preclinical development. And then if we look at other clinical programmes, notably our co-development programme 527 with Abtivo, we are currently, as I said, at the end of phase one, we are considering next steps and our strategic options together with Abtivo. And then finally, something that also happened recently is that the outlicensed molecule called HLX22 or AC101, if you wish. outlicensed to Henleus, now ended a phase three study in China. Hence, this molecule is both in phase two and phase three clinical development. And I remind you that the alligator is eligible to approximately a third of the milestones and royalty income from that molecule through our legacy agreement with the with south korean ab clone so a laser focused uh mrs laser focus on on mr salomap and then a couple of other molecules that are continuing to to build the mid and long term value for alligator if we go to the next line yeah so this is uh this is uh just to remind ourselves that we recently announced some encouraging news from our dialogue on manufacturing not only with the u.s fda but also with the german paul ehrlich institute which is one of the european what can we say benchmarking regulatory agencies the leaders in antibody development and normally companies like alligator don't speak too much about manufacturing it's something that needs to be done it's maybe not that engaging to talk about as clinical data but if you don't have a phase three ready process if you don't have gmp material from that phase three ready process then you are basically not able to start your phase three study And we have invested in this over the last couple of years and during Q3 and Q4 we have engaged with first the German authorities and then the US authorities to get feedback on our manufacturing process, the status and the planned activities. And I can tell you that the very unanimous feedback from these agencies is that Alligator is doing everything correctly and that the process that we have established is phase three enabling and phase three ready. And hence we started manufacturing of GMP material late 2024, just before Christmas. And just again, I want to remind ourselves that this is a significant risk reduction in the program. If we look at quite a substantial number of the so-called complete response letters that the FDA issues, so messages to the companies that their drug is not being approved, A large part of these are actually not based on the clinical data, but based on regulatory issues or manufacturing issues. So having this very clear feedback from two independent US and European authorities takes out a lot of the risk in metacetamol. So let's go further. On the next slide, and just again to remind ourselves that we have a very encouraging set of data from mitocelumab in first-line metastatic pancreatic cancer. We are especially encouraged both by the durability of response, so how long do the individual patients have tumor control once they get mitocelumab and chemotherapy, the overall survival, sort of the benefit we provide there. We previously talked about the number of patients that actually have sustained or long-term survival benefit from metacetamol in combination with chemotherapy, which reflects into a very significant increase in the so-called 18 months overall survival rate, so how many of the patients are still alive after 18 months after diagnosis. And importantly, as we have discussed before, mid-February, late February, we expect to announce so-called 24 months follow-up data. So that means we will be able to look at how many patients were actually alive two years after after diagnosis. This is not a set of data that is normally being announced in this indication, first-line metastatic pancreatic cancer, as most trials don't have a substantial number of patients surviving that long. So there is something to look forward to in February. And with that,

i think i'll hand it over to you johan to take us through the financials and i'll be back towards the end of the session so next time yeah next slide please so let's start with the q4 numbers down there the p l and we have reported quite significant net sales during the quarter and as you have been informed through a press An agreement with Orion on the previous collaboration that we now have ended, reported three and a half million euros in net sales for that ending of the agreement. And there are also some other activities with Orion during the quarter. When it comes to the cost side, we have continued to have high costs on the phase three trial. but also the other phase three enabling activities such as CMC production as Søren mentioned and also the actual closure of the phase two study. On top of that we see also some costs for the for the restructuring that we are doing. Most of that will come in the first quarter of 2025 but there are certain costs that we already now have been required to report. One of them is the cost for the lab facility that we were supposed to take over in December 2024. Unfortunately, with the restructuring, we have no need for that. And as IFRS requires, we have written down the right of use for the full amount. And hopefully, we will get out of that contract as soon as possible and working together with American Village, the landlord, And as you can see down to the right, we continue to have most of our costs with mitazolamab, and that will be even more clear in the coming quarters where we have mitazolamab and general expenses only then, and no other activities when it comes to discovery or preclinical, et cetera. Next slide, please. And as you can see down to the left, we have a downward trend when it comes to our cost level, and that will continue, as I mentioned, and in 2025, we will have some costs for CMC and also for the phase two in the first half. But after that, we will really have more of the organizational costs and quite a low burn on a monthly basis in the second half. And our liquidity situation at the end of December 2024 is 64 million. That includes the bridge funding that we receive in conjunction with the release of the rights issue that's upcoming. And we will have to repay the bridge financing with part of the proceeds from the rights issue. And of course, we will look at other things that could help us on the financing side. But now, with the rights issue in place, with a prudent assumption around the warrants that we will also issue them for during 2025, subscription in 2025, we believe that we have the financing secured for the full year 2025. Next slide, please. So let's take a time to reflect on the rights issue here and see what is upcoming then. The prospectus will be out in the next week, so you can read all of the details in the prospectus, but this is a little bit of a summary of that. It's a provincial rights issue of units, which include then, of course, ordinary shares, but also the warrants that are labeled TU12 and TU13. There are two different scription periods for the two different warrants. in total the units are issued at in total 280 million if it's fully subscribed and if we have them before we launch this secure the level at 140 so we know that 140 which is very important for our financing on 2025 that is secured hopefully there are more shareholders that are interested to subscribe and then we can arrive closer to 280 of them The units rights will be subject to trading, which is customary. Also the TU12 and TU13 will subject to trading post the rights issue has been completed. And for your shareholders, I think it's important to, you know, you need to act here. You will get your units rights, that's clear, but you don't have to either then subscribe for your allocated unit rights, sell unit rights that you don't want to utilize. So that's very important. Of course, you can buy and if you want to be more invested in alligator, that's fine as well, of course. But there are a lot of information that you need to look into in the prospectus, but also there are information from your local bank that may have other dates that you need to be really careful to don't lose important values here. A question that has already popped up, and I think we all agree on that, that we need to conduct a reverse split. That is nothing that we can do overnight, so it will take some time, but we will await the outcome of the rights issue before we then launch this reverse split. It's something that we will do more or less automatically for you guys, but something that will happen prior to the AGM to be able to come to a better and more reflecting share price, but also the number of shares will be significantly lower. Next slide, please. I have done this kind of simple example to try to walk you through how this subscription will work. If you have a shareholder that owns 50,000 shares and they would like to subscribe for their Prorata share, the 50,000 shares will then lead to 1.850,000 unit rights. You need 10 units rights to subscribe for units. You will then have 185,000 units and each unit costs 10 öre or 0.10 SEK. And that will be an investment of 18,500 for you. What will that lead to? You will then have after that 1.9 million shares. You have 50 initially and you will receive 1.850 additional ones then. So you have 1.9 in total. You will, on top of that, free of charge, get 1.850,000 TU12 and 925,000 TU13. In addition to that, it will be utilized in May and September. We will continue to provide additional information around this through different means and happy to answer questions that may rise as well. But I urge you to read the prospectus and also then reach out to your local bank so that you get the correct information from how to act on your holdings. Let me see. I think I'm done. Maybe that's over to you, Søren, again.