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.

Thank you, Johan. So maybe the next slide would be prudent. Yeah. So what can you expect from Alligator during 2025? If we focus on mitocelular map and key events, we already reported on the US and European regulatory interactions on CMC. We are also, in the near term, engaging with the FDA again on a so-called End of Phase II meeting, and we expect to be able to announce the outcome of that sometime during Q1. That depends, of course, on FDA's internal timing. Then very importantly, and I have already talked about that, the 24 months follow-up data from the OPTIMIZE 130, we expect to announce that during the later parts of February. And in connection with that, we will also provide the top line data from the 450 cohort. In addition to this, you can expect additional data from Metasalomab to be published during the first half of 2025. We don't have an exact date, we don't have an exact format of these publications. Some will be in what we can call conference proceedings or abstracts. Some will be in scientific documents or scientific papers. And we will, of course, announce those data as we go along. And then with a partner, phase three initiation should be possible in the second half of the year. So in summary, a very strong performance operationally and scientifically in 2024. a rights issue and a cost-saving programme and a reorganisation programme that has been executed here in December and early January. There will be some run-off costs from that and then some very essential regulatory interactions and key data readouts in the first quarter of next year. Okay, I think that was it for the presentation. If we can just take one more slide, actually, and what do we look at in terms of the key strategic objectives? Of course, the rights issue this year to support our continued operation and value creation. METASALOMAP phase 3 initiation during the year with a partner. And then we still believe that METASALOMAP is on a trajectory for an approval, sometimes around 2030. And with that, I will go to the Q&A. Good, and we have a number of questions initially for you, Johan, if you are up for that. Yep. We have a couple of questions here from Richard at Red Eye who wonder if you could comment on our burn rate and the financial runway in 2025 in either the current 50% guarantee scenario or if 100% subscription.

Yeah, I mentioned that in my presentation, but the secured level, together with the prudent assumption around the TU12 and TU13, will take us through 2025. We have a higher burn in the first half, lower burn in the second half. If we get full subscription, we will then use that money in a careful way, repay earlier and act on that. But we will have to come back on that because we haven't

it's not in the in the cards for the time being that we have full subscription but we will we will be very glad to have that let's call it a problem that we have too much cash just uh just a comment here i i don't think the too much cash is probably not a normal issue in in biotech companies but thank you johann and i think i think this also answered a couple of questions from louisa from from kempen Another question here from Richard about the 40 million write-down. I think you also mentioned that that's part of the facility lease.

That's correct, and IFRS require us to write down if we don't can use those assets and we are not taking that into possession. We are moving to a much smaller facility than for the remaining workforce and try to sublet this or get out of the contract together with American Village. And of course, if that happens, there will be an effect on the P&L as well, but this is the prudent way to recognize this asset.

Thank you. And then just again a question here from Luisa, and I think you also already answered it, but I think it can be repeated here. Can we assume that expenses in 2025 will remain at the level of Q4 2024?

Initially, yes, more or less, but it will be lower and lower throughout the year. Because we will be finalizing the CMC initiative, we will also then close out more sites and activities when it comes to the phase two study.

Thank you. And then I think we have a couple of questions for me. The more scientific part, there is a handful here on mitosalumab. We will start off with that. So a question here from Louisa, will you report more data from the additional lower dose, the 450 microgram per kilogram cohort, of the OPTIMIZE-1 trial and what kind of data. So we will initially announce the top line data in line with what we originally did for the phase 2 dose, the 900 microgram dose. And then, as we remind ourselves, this cohort was originally included on a request from FDA to make a series of so-called exposure response studies. So at a given exposure, how does the response to META differ from what you see with 900? And again, we then have to hold that data up against the very strong both efficacy and safety data packets on 900 and recommend the dose to FDA during the spring here. So that is exactly what we are doing here. FDA has not requested that we follow these patients up as long as we've done in the 900 microgram cohort, so we will most likely not follow these patients as long, as rigorously as we have done with the 900 microgram dose. If we take another meta-SELMAP question here from Richard. Can you discuss what Mr. Salomab needs to become deal-ready? What is the relative importance of CMC, the 400 microgram cohort dose, the two-year readout and other preparations? I think that sort of summarizes very well exactly what we are doing. CMC is expensive. complicated and burdensome, but it's something that you simply have to do to be able to do your phase 3 study. So that is very, very important that we have invested in that, that we've gotten regulatory feedback and that we have invested in manufacturing the material that a partner needs to have on site to be able to start a phase 3 study. The 450 microgram cohort, as I just alluded to, is important in In response to FDA's regulatory advice on dose characterization, the company is still of the standpoint that we believe that the 900 data is very, very strong. And the 450 microgram cohort data, as I just described, will be used to come up with a final dose recommendation for the Phase III study. The 24-month readout for me is essentially really the data point now that shows and demonstrates the immune therapeutic effect of metacetamol. that we see these very, very long and sustained survival benefits for a significant number of the patients really hammering home the value of mitosalimab and the relevance of this treatment over chemotherapy alone. And then, of course, other preparations like getting biomarker data analyzed and published and getting our interface to meeting with the FDA conducted, as I alluded to earlier, these are all points that sort of gets me to sell them up. Phase two wrapped up and ready for phase three, and hence also also do you ready? And we are on track with that. Then we have another question here about where are we with partnering discussions and did we go to JP Morgan? No, this year we prioritized not going to JP Morgan based on the feeling that we had a number of ongoing dialogues that would not really be advanced further by a 20-minute meeting in a hotel lobby in San Francisco. And also based on the fact that we have data coming out in February, I'm of the opinion, based on my 25 years experience in the field, that having dialogues with people based on data that is relatively well known and telling people that you'll have more data in eight weeks is not really valuable. So we decided to focus on the work here in Lund, saving the money and getting ready to re-engage our our current discussion partners and new potential partners when we have the data later in the quarter. Okay, then that wraps up. Mr. Salomar, we have a couple of questions about the other programs, about 527, on the ownership and the cost structure here. so 527 is co-developed and co-owned by optivo a seattle-based listed biotech company and when i say co-owned i mean co-owned we own 50 each and we take decisions in in unison and we also share the cost equally and and as i said we're currently evaluating the data from the phase one dose escalation study that we believe is encouraging, and then we're looking at next steps and potential costs associated with that. But just to reiterate that metacetamol is our primary, secondary and tertiary focus as we go into 2025. And I think that also answers Richard's questions about 527 and then Neo X prime of 4066, which we see as the next generation with the saddle map. That will unfortunately be put a little bit on the back burner. We still believe it's a very interesting program, either for a partner to META, to have the follow-up candidate in-house as well, or as an alligator molecule to be developed and invested in once we have transacted on META-Cellulomab. And I think I basically think that that is the questions that we have received. I also always want to encourage you to, if you have additional questions, write them to our investor relations mailbox. at ir at alligatorbioscience.com then we will get back to you with your answers to your questions comments or concerns and with that i want to thank you for listening in today thank you for your interest in alligator bioscience and thank you for your loyalty and support as shareholders thank you thank you