Alligator Bioscience AB (publ) (ATORX) Earnings Call Transcript & Summary

So hello, and welcome, everybody, to Alligator Biosciences 2024 Year-end Report Call. My name is Greta Hoog. 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 Bregenholt; and our CFO, Johan Gileus. They will walk you through their 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 Soren.

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 Greta 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 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-1 study early in the quarter 2024. We followed up later in the first half with the first interim data from the Phase I study of the molecule we call 527. Those who follow the company knows that, that's a molecule we co-develop with U.S.-based Aptevo. Just around the mid of the year, we announced very encouraging 18-month survival data from the OPTIMIZE-1 study, and we'll take a glance of 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-1 Phase II study on a lower dose of mitazalimab, 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 have 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 I data from 527, very interesting data at the last dose of the dose escalation trial. And then a couple of weeks ago, we announced the outcome of the first of a set of regulatory interactions with the U.S. 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 mitazalimab in first-line metastatic pancreatic cancer justifies further investment in the molecule. The next step here is a randomized registrational trial or phase trial -- 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. To continue the -- 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 mitazalimab and continue to building that -- building value into that program as we develop it towards Phase III. It's, of course, important in such a transaction that you -- or such an that you, with surgical precision, try to retain those essential resources that are needed to bring forward mitazalimab in this situation. And fortunately, we were able to do so. So the remaining Alligator organization is focused on mitazalimab, is solely focused on mitazalimab, and is fully capable of continuing the path that we have started with the program towards Phase III. Can I have the next slide, please? If we look at the pipeline here, just to recapitulate a few messages here. So mitazalimab on the home stretch of the Phase II study, we expect 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-microgram data that are important to be able to initiate Phase III. 4066, which we see as the follow-up candidate to mitazalimab is currently in early preclinical development. And then if we look at other clinical programs, notably our co-development program, 527 with Aptevo, we are currently, as I said, at the end of Phase I. We are considering next steps and our strategic options together with Aptevo. And then finally, something that also happened recently is that the out-licensed molecule called HLX22 or AC101, if you wish, out-licensed to Henlius, now entered a Phase III study in China. Hence, this molecule is both in Phase II and Phase III clinical development. And I remind you that Alligator is eligible to approximately 1/3 of the milestones and royalty income from that molecule through our legacy agreement with South Korean AbClon. So a laser focus on mitazalimab and then a couple of other molecules that are continuing to build the mid- and long-term value for Alligator. If we go to the next slide? Yes, so this is 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-Institut, 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 III ready process, if you don't have GMP material from that Phase III ready process, then you are basically not able to start your Phase III 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 U.S. 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 III enabling and Phase III ready. And hence, we started manufacturing of GMP material late 2024, just before Christmas. And just again, 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 2 independent U.S. and European authorities takes out a lot of the risk in mitazalimab. 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 mitazalimab 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 mitazalimab and chemotherapy, the overall survival, sort of the benefit we provide there. We previously talked about the number of patients that actually have sustained long-term survival benefit from mitazalimab 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 of -- 18 months after diagnosis. And importantly, as we have discussed before, mid-February or 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 2 years 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 slide?

Next slide, please. So let's start with the Q4 numbers then. The P&L, and we have reported quite significant net sales during the quarter. And as you have been informed through a press release, we did an agreement with Orion on the previous collaboration that we now have ended and we reported EUR 3.5 million 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 cost on the Phase III trial, but also the other Phase III enabling activities such as CMC production, as Søren mentioned, and also the actual closure of the Phase II study. On top of that, we see also some costs 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 the Medicon Village, the landlord. And as you can see down to the right, we continue to have most of our costs with mitazalimab, and that will be even more clear in the coming quarters where we have mitazalimab 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 then to the left, we have a downward trend when it comes to our cost level, and that will continue, as I mentioned, then in 2025. We will have some costs for CMC and also for the Phase II in the first half. But after that, we will really have more of the organizational costs, et cetera, and quite a low burn on a monthly basis in the second half. And our liquidity situation then at end of the December 2024 is SEK 64 million. That included the bridge financing that we received in conjunction with the release of the rights issue that's upcoming. And we will then 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 assumptions 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 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 preferential rights issue of units, which include then, of course, ordinary shares, but also the warrants that are labeled TO 12 and TO 13 are 2 different subscription periods for the 2 different warrants done. In total, the units are issued at in total, SEK 280 million if it's fully subscribed. And if we have then before we launched this secured the level at SEK 140 million. So we know that the SEK 140 million, which is then very important for our financing of 2025, that is secured. Hopefully, there are more shareholders that are interested to subscribe and then we can arrive closer to SEK 280 million. The unit rights will be subject to trading, which is customary. Also the TO 12 and TO 13 will subject to trading post the rights issue has been completed. And for you shareholders, I think it's important to -- you need to act here. You will get your units rights, that's clear, but you then 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 and that have other dates, 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 then prior to the AGM to be able to come to a better and more reflecting share price, but also then 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 then. And if you have a shareholder that owns 50,000 shares and they would like to then subscribe for their pro rata share, the 50,000 shares will then lead to 1,850 unit rights. You need 10 units rights to subscribe for units, you will then have 185,000 units and each unit cost 10 öre or SEK 0.10 and that will be an investment of SEK 18,500 for you. What will that lead to? You will then have after that 1.9 million shares, you had 50,000 initially and you will receive 1850,000 additional ones then. So you have 1.9 million in total. You will on top of that free of charge, get 1,850 TO 12 and 925,000 TO 13 in addition to that, that you will be utilized in May and September then. We will continue to provide additional information around this with -- through different means and happy to answer questions that may arise as well then. 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 then. Let me see. So I think I'm done, and maybe that's over to you, Søren, again.

Thank you, Johan. So maybe the next slide would be prudent, yes. So what can you expect from Alligator during 2025? If we focus on mitazalimab and key events, we already reported on the U.S. 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 sometimes during Q1. That depends, of course, on FDA's internal timing. Then very importantly, and I have already talked about that, the 24-month follow-up data from the OPTIMIZE-1 study will -- we expect to announce that during the later part 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 mitazalimab 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 III initiation should be possible in the second half of the year. So in summary, a very strong performance operationally and scientifically in 2024, rights issue and cost-saving program and reorganization program that has been executed here 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, mitazalimab Phase III initiation during the year with a partner. And then we still believe that mitazalimab is on a trajectory for an approval sometime 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 for that?

Yes.

We have a couple of questions here from Richard at Redeye 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?

Yes. I was mentioning that in my presentation, but the secured level, together with a prudent assumption around the TO 12 and TO 13 will take us through 2025. We will 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 -- but we haven't -- it's not in the cards for the time being that we have full subscription, but we will be very glad to have that, let's call it, a problem that we have too much cash.

Just a comment here. I don't think too much cash is probably not a normal issue in biotech companies. But thank you, Johan. And I think this also answered a couple of questions from Louisa from [ Kempten ]. Another question here from Richard about SEK 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 use those assets, and we are not taking that in a possession and that we are moving to a slight much low -- smaller facility than for the remaining workforce and try to sublet this or get out of the contract together with Medicon Village then. 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 these assets.

And then just again, a question here from Louisa. And I think you also already answered it, but I think it can be repeated here. Can we assume that expenses in '25 will remain at the level of Q4 '24?

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

And then I think we have a couple of questions for me. On the more scientific part, there is a handful here on mitazalimab. 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 have, what we originally did for the Phase II 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, do you see -- how does the response to Meta differ from what you see with 900? And again, we then have to hold that data up against a very strong both the efficacy and safety data package on 900 milligram and recommended 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 mitazalimab question here from Richard. Can you discuss what mitazalimab needs to become deal ready? What is the relative importance of CMC, the 400-microgram cohort dosed 2-year readout and other preparations? I think that sort of summarizes very well exactly what we are doing. CMC is expensive. It's complicated and burdensome, but it's something that you simply have to do to be able to do your Phase III study. So that is very, very important that we have invested in that, and we've gotten regulatory feedback and that we have invested in manufacturing the materials that a partner needs to have on site to be able to start a Phase III study. The 450-microgram cohort, as I just alluded to, is important in response to FDA's regulatory advice on dose characterization. The company is still of the standpoint that we believe that the 900-milligram 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 year 2, the 24-month readout for me is essentially really the data point now that shows and demonstrates the immune therapeutic effect of mitazalimab that we see this very, very long and sustained survival benefits for a significant amount of the -- a significant number of the patients really hammering home the value of mitazalimab 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 end of Phase II meeting with the FDA conducted, as I alluded to earlier. These are all points that sort of gets mitazalimab Phase II wrapped up and ready for Phase III and hence, also deal 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 JPMorgan? No, this year, we prioritized not going to JPMorgan 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. And 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 8 weeks is not really valuable. So we decided to focus on the work here in Lund, saving the money and getting ready to reengage our current discussion partners and new potential partners when we have the data later in the quarter. Okay. Then that wraps up mitazalimab. 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 Aptevo, 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 unison, and we also share the cost equally. And as I said, we are currently evaluating the data from the Phase I dose escalation study that we believe is encouraging. And then we are looking at next steps and potential costs associated with that. But just to reiterate that mitazalimab 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 the Neo-X-Prime or 4066, which we see as the next-generation mitazalimab, 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 mitazalimab. 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 [email protected], 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.