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

Hello, and welcome to Alligator Bioscience's 2025 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 are our CEO, Soren Bregenholt; and our CFO, Johan Gileus. They will walk you through the latest developments from the previous quarter and the year as well as the upcoming news flow. After this, they will be happy to take any questions you may have. You can post them in the Q&A function of this webinar or you can send them by e-mail to [email protected]. As you know, Alligator Bioscience is a publicly listed company, and I'd like to note that today's presentation may include forward-looking statements. Please refer to the disclaimer on this slide, which applies to the full presentation. With the formalities out of the way, I'm handing this over to you, Soren.

Thank you, Greta, and it's a pleasure to welcoming you all to this Q4 or end year report call in Alligator Bioscience. What we will do today is go through some of the events of the fourth quarter, of course, and we will focus primarily on mitazalimab, and I'll also provide you some information about our partner program, HLX22. So Greta, if I could get the next slide, just to get going. What has happened sort of on the highlights in the company. We have published 2 exciting papers, very exciting papers on mitazalimab, all the biomarker data from the Phase II study and we published in Cell Reports and also data from the REACtiVe-2 study, which was an investigator-initiated study, also in pancreatic cancer, where we combined mitazalimab with chemotherapy and also with a dendritic cell vaccine that was published in Nature Communications. And I'm, of course, not mentioning these 2 publications just for the sake of it, but of course, to highlight the underlying strong data, both clinically and also mechanistically, and I'll share a little bit with you in just a few seconds. In addition, we have completed a rights issue of around SEK 91 million in gross proceeds. And as part of that, there is a number of outstanding warrants in the series TO 14 and Johan will talk more about that later during the call. On the general portfolio, we further strengthened the IP position of yet another U.S. patent approval on our bispecific molecule, ATOR-4066, so the CD40/CEACAM5 bispecific antibody. And then on the HLX molecule HLX22, Henlius received the regulatory approval in China for their Phase II/III trials in HER2-positive breast cancer. And we'll talk more about those in just a second. If we go to the next slide, Greta, one of the key points in Q4 was the release of the readout of the 30-month data. That was actually in Q3, and we published these data at ASCO GI in January. And I thought I wanted to share with you sort of the entirety of the Phase II population treated in the Phase II study. So what you see here on the slide is a so-called waterfall plot of the best clinical response for all the individual patients treated with either the low dose 405 (sic) [ 450 ] micrograms or the high dose 900 micrograms of mitazalimab in first-line metastatic pancreatic cancer. And even though the slide looks incredibly busy, I think there's a key -- a couple of key points that we need to take from this. Key point #1 is that when you compare the light green, the 450 with the dark green, the 900, I think we can all agree that the 900 dose gives more responses in more patients, meaning that 900 is and all the statistics show this better than 450, hence the FDA's and EMA's recommendation and endorsement of 900 microgram as the Phase III dose. But what is equally important is that we can see, when patients actually do respond to 450, we have clinical responses that still shows that even at this dose, although in fewer patients, the drug is still active. And most notably, as you can see to the right-hand side, we actually now have additional 2 complete responders. So now a total of 5 patients have complete responses to mitazalimab in this very hard-to-treat indication. And in addition to this, you can see that we have 2 patients with more than 80% and one of them close to 90% reduction in tumor burden. So together, this data tells us 3 things. It corroborates sort of the clinical benefit of mitazalimab, it shows us that we consistently get deep and long responses. And it also shows us clearly that 900, the Phase III dose, is better than 450, meaning that we have a clear dose response in this Phase II study with mitazalimab. And that's, of course, something that we are happy to see. If we go to the next slide here, you have seen these data before, on the left-hand side here that we have a significant effect of mita on the median overall survival and on the durability of response. And when you look at the hallmark data, as we've discussed previously, we increased the probability of being alive at 18 months by a factor of 2, at 2 years by a factor of 3, and at 2.5 years by a factor of 4 of mitazalimab in comparison with the chemotherapy backbone. And when we look at the combination of the clinical profile of mitazalimab with a safety profile that is consistent with FOLFIRINOX, which allows combination with this chemotherapy and dosing for extended periods of time. We have several patients that have been on the drug for more than 2 years and some patients even longer. When we compare that with the deep and durable responses with 5 patients in -- with complete responses, we see we maintain our position that we have a drug here that in itself, together with chemotherapy, can play a significant role in first-line therapy of pancreatic cancer, but definitely also in combination with other molecules, synthetic lethals like KRAS inhibitors that are becoming a player in -- at least in second-line metastatic pancreatic cancer. So a strong suite of clinical data with -- today with a focus on adding additional patients to the pool of complete responders. If we take the next slide, Greta, just not to overburden you with the technicalities here, but just to remind us all that, we previously discussed a strong correlation between the hypothesized mechanism of action of mitazalimab in its ability to activate the immune system and have a direct link of that with the long-term clinical benefits of the drug. And then today, we add, for the sake of it, the lower right-hand corner of the graph here, data coming out of the Phase I study done together with the Dutch University and recently published in Nature Communications, very clearly showing that when you provide mitazalimab to patients with pancreatic cancer, one of the mechanisms that we have hypothesized is the decrease in connective tissue or stroma in the tumors. And these data clearly shows a significant decrease in that particular and important aspect of the disease. So again, building on the mechanistic evidence that mitazalimab is doing exactly as we wanted to do in these patients. If we then go to the next slide, and as I said, we have now completed OPTIMIZE-1. There are still a little handful of patients on treatment, both at 900 and at 450. These patients will continue to receive mitazalimab as this is a medication that keeps them alive. But other than that, we are not collecting data in the study longer -- any longer, and there will be no more data readouts. Where we will get data readouts is for the number of Phase I and Phase II studies that we have started both in the U.S. and in Europe based on the very strong investigator interest in mitazalimab. And we have a number of studies that are open and recruiting both in oral premalignancies in pancreatic cancer and breast cancer on U.S. Ivy League University. As these trials are investigator-led, Alligator is not really in complete control of when the first and subsequent patients are being enrolled into the trial, but we will keep you updated when that happens and there are major events in these studies. What I do want to emphasize, of course, and we've spoken about this before, is the study in biliary tract cancer that will be run by the French group called Unicancer study, if we can have the next slide, Greta, that is basically a randomized Phase II study run by at Institut Curie and a few other hospitals across France, enrolling 112 patients in biliary tract, randomized 2:1. So every time there's 2 mitazalimab patients, there will be one control patient. And we expect this study to start in the second quarter of this year. So biliary tract is a rare and highly lethal gastrointestinal cancer. It's orphan drug. It qualifies for orphan drug with around 30,000 cases a year in the U.S. and in Europe and around 200,000 cases worldwide. The median OS remains around a year, even with the approved IO combinations in first line, hence, the unmet medical need is significant. And there are really few effective systemic treatment options. So why is this trial being run? It's being run because the investigators that have familiarized themselves with mitazalimab in pancreatic cancer, to a large extent, it is also the same physicians that are treating other gastrointestinal cancers. And the activity that we have seen in pancreatic cancer together with FOLFIRINOX have led to the conclusion that it is relevant to try mitazalimab in combination with FOLFOX. So a subset of the FOLFIRINOX frontline, so FOLFOX and mitazalimab in second-line in biliary tract. So just to remind you, the study is a randomized Phase II study. It gives the opportunity to actually add a Phase III arm if the Phase II study is positive and that Alligator is providing mitazalimab to the investigators and minimal financial support in terms of scientific support, a little bit of insurance, and pharmacovigilance. But other than that, a cost-free study for Alligator. With that, I think we'll continue with HLX22. For those of you who are not familiar with HLX22, it's an innovative HER2 monoclonal antibody that is currently being developed by a Chinese company, Shanghai Henlius Biotech under license from AbClon and the molecule was discovered, followed a collaboration with Alligator and we have a certain financial potential upside by HLX22. And without going too much into the financials, our conservative estimate of a potential royalty stream on annually between SEK 150 million and SEK 400 million, remains unchanged. I think that it's fair to say that based on the data that has been published, the probability of the progress in the Phase III study, I think we can say that the probability that this will materialize has increased. Why do I say that? First of all, the Phase III study is ongoing, and I will show some of the data in the next slide. But if you look at the table here, we have listed all the ongoing studies and planned studies that Henlius have announced. So the Phase III study in gastric cancer is ongoing. It's a 550-patient global study. It's based on a very strong set of Phase II data that I'll share you within a second. There is a breast cancer Phase II study ongoing that hopefully will be completed soon, if not already. And that has led to the initiation of -- the planned initiation of 2 additional studies in breast cancer, study in the neoadjuvant setting and a study in recurrent breast cancer. And you can see from the table here that Henlius expect to enroll approximately 1,500 patients across these trials. And then it's also worth noting that the company is planning to start recruiting in a small pancreatic cancer study, just like we've been running with mitazalimab. So a strong expansion of the HLX22 program that, of course, is expanding the clinical footprint and of course, also the commercial opportunity for Henlius and hence the commercial opportunity for Alligator going forward. Then before we jump into the HLX2 (sic) [ HLX22 ] data and the Phase III trial, I thought it would be interesting just to mention that a new molecule has materialized called HLX49, which is a bispecific antibody derived -- antidrug conjugate, sorry, partly derived from HLX22. Let's see where that is going. But as per the HLX22 agreement, Alligator also holds a certain financial interest in this follow-up molecule. It's early, so we don't really ascribe any tangible value to that in our current financial modeling. So if we go to the next slide, Greta, just to sort of even the playing field here. So we have the same set of information when we talk about HLX22, the company reported the Phase II data at ASCO GI, and you can see that -- in January, and you can see them in the upper right-hand -- upper left-hand corner of your screen here. And basically, what you can see is that compared to the control group, which is a complex treatment of an antibody and chemotherapy called [indiscernible] plus -- minus pembrolizumab, when you add HLX22 to that combo, that is the orange line there, you can see a very strong separation. And when you run the statistics, HLX22 actually infer up to an 80% reduction in the risk of disease progression or death. So a very strong Phase II clinical data that we, of course, not only for the patients, but also for the valuation of the company that we hope will translate in the Phase III study. So in summary, good progress on mitazalimab, which is in Alligator's control and also strong progress on HLX22 driven by Henlius. And with those notes, I will leave the word to you, Johan.

Thank you, Soren. Can we have it back up? Perfect. Thank you. So this is a snapshot of the financials for the Q4 2025. And as expected, we are seeing decreasing expenses due to the fact that we have more or less closed the clinical trial for the Phase II, and we also have completed the IMP production as communicated earlier. The second thing that I would like to point out is the net financial items that are quite huge, and it's an effect out of the TO 14 and previous to that, the TO 12 and TO 13 and also the Fenja renegotiation that we have done during 2025. All of that, if you are interested, you can see quite extensive disclosures in the Q4 report and previous report as well. So if you want to dig in deeper to that. But all in all, it's mainly effect of -- should go through the P&L or go directly to equity, if you want to summarize it. Can we have the next slide, please? And here is more of an optical graph of the decrease in cost, and we are coming down to a baseline that is between SEK 15 million and SEK 20 million per quarter in 2026, given that we're not doing anything additional to this baseline item. The liquidity position of the company is now SEK 62.2 million, and we can then also conclude and communicate that all of the money from the proceeds have now arrived before the year-end. So that's the total amount. And then, of course, we had some bridge financing and repayments to be made. That's why the cost -- the total liquidity position is lower than the actual capital raised. And as we sort of mentioned before, we also have the upcoming TO 14 that I will cover on the next slide. Finally, then, of course, we understand that this will take us then to Q2 2026 then. But of course, we are looking into various means of extending our runway and financing activities going forward. But let us come back on that. Next slide, please. So here, we have the TO 14 in a snapshot, and we can maximum raise additional SEK 61 million gross and this is due to the quite narrow interval that we now know about for the subscription done. So it's between [ 20 or 25 ], and we are just now in the pricing period. And so we will know in a week or 2 then exactly the subscription price then. And of course, the uptake will be -- determine the proceeds that we can raise. And as you can see to the right then, we do have the subscription period coming in the beginning of March, up to mid-March. And I think that's clear to -- good for you to know that you at least know to act on your subscriptions or your TO 14s done. And you can also then trade the TO 14 buy or sell, additional TO 14 then up to 17th of March. With that, I think I will hand over to you, Soren, before we take any questions.

Thank you, Johan. Just needed to get the technology work. Yes. Thanks. So if I can have the next slide, I just want to reemphasize a few points that the Phase II trial with mitazalimab in pancreatic cancer is now completed. We have seen unprecedented landmark survival data at 30-month 21% survival versus an estimated 5% for the chemo backbone. And that very nice set of data has now sort of been accompanied by another set of complete responders, bringing that number up to 5. And it's very clear that this data warrants registrational development in the indication. That's not only something that Alligator thinks, but that is the widespread belief with our key opinion leaders, both in Europe and the U.S. And the drug is Phase III ready, and we have established a regulatory path to approval. And of course, we continue to speak with potential partners about global deals and also in certain extent, regional deals. Then we are exploring and executing development options beyond PDAC as we just discussed, where the most tangible -- no, tangible is not the right word, but the most prominent now is the randomized Phase II study in biliary tract cancer that we will expect to start in the second quarter of this year, which we really believe the fact that it's a parallel indication, it's parallel disease biology, parallel chemotherapy, and the fact that it's a large randomized study, really is a true development option for mitazalimab in addition to pancreatic cancer. And then as we discussed, the HLX22 program developed by Henlius, strong Phase II clinical data in gastric cancer leading into a global trial that is creating some attention. And based on the Phase II study in breast cancer, we also see the clinical program expanding in that indication with 2 new Phase II/III trials in breast cancer. And then finally, I introduced you to HLX49, a bispecific antibody drug conjugate that is partly delivered from HLX22. So a steady quarter, rounding up a very significant year for Alligator, moving mitazalimab forward, reading out good data yet again, and closing down the trial as expected. And as Johan just mentioned, bringing down to the burn rate to a relatively low level of between SEK 15 million and SEK 20 million per quarter. And with that, we'll take a couple of questions. Remember, you can always use the chat as we speak.

We have a couple of questions here from Filip from Redeye, and I can see that there is a small handful here. Filip writes that RAS inhibitors or KRAS inhibitors, if you will, have taken a center stage in drug development in pancreatic cancer and other solid tumors. And Filip then ask, it seems like mitazalimab can be a useful combination partner with these inhibitors. And what are my thoughts? What are our thoughts on that? And do you have any discussions with potential partners? I think that's a very timely and thoughtful question. So thank you for that, Filip. Yes, KRAS inhibitors are most likely getting approved in second line, probably already this year. And the leader in that drug class, Revolution Medicines has announced that they will start a couple of Phase II/III studies with their various inhibitors also in first line this year. So at least we know that RAS inhibitors will change the second-line landscape. And I think we can be fairly certain that they will also have some impact on the first-line landscape, absolutely. We will see how it pans out. I think what is clear from -- to your point here about combination, what is clear from a number of independent preclinical studies combining KRAS inhibitors with CD40s, not done by Alligator, but by independent researchers, it's clear that mechanistically, the 2 drug classes work nicely together in CD40 agents -- CD40 agonist giving deeper and also more durable responses in combination with KRAS inhibitors than the KRAS inhibitors alone. So that's clearly a yes, we believe that mitazalimab will be a very good combination partner with KRAS inhibitors as it is with chemo alone, both because of the mechanism, but also because of its benign safety profile. It's, of course, important when you combine drugs and you keep stacking drugs on each other in first and second line that these drugs have a safety profile that allows that to happen. Then the second part of the question is that do we have any discussions with potential partners about that? I would say, we not only have discussions with partners about that, but we're also talking to a number of clinicians that have asked themselves exactly that question that Filip has, and we're exploring opportunities to actually run clinical studies in that combination in the IIT setup that we just described. So that was a long answer to a very important question. Then we have a couple of questions here, all on the same theme. It's one from Joseph Hedden from Rx Securities. There's one from a gentleman called [ Benzy ]. I know his full name, but anyway, and we also have a question from Filip around the milestone coming from earned or to be earned from the Phase II study with HLX22. And AbClon's CEO has announced that he expect that milestone to be paid during first half of 2026. I'm not necessarily commenting on his comments. But yes, that is definitely a probability. And I'm not going to -- I'm not free to let you know what that -- what amount that that's going to be. But I can tell you, and I think I said this before, that it's relatively modest. It's based on the fact that the drug was licensed at a very early stage. And the clear upside to Alligator is through the eventual royalty payments.

And, Soren, yes, just to add on that subject, it's also then paid once the study is completed. So it has nothing to do with top line North America, when they complete the study. So the study will continue because the patients are still on treatment, then the payment of the milestone will be deferred.

Absolutely. Good. Then the third question from Filip is, are you considering divesting your interest in HLX22 to a royalty pharma or maybe AbClon? I would say that, yes, we are. It is being discussed to a certain extent. I think we need to also realize that the value of these royalty streams is a function of probability of success, not only value. So it's clear that the closer we get to read out, the potential value of monetization will be -- will increase. And for Alligator's management and Board, it's really about finding the right balance, not selling the future royalty too cheaply to solve, what can we say, negligent, but a smaller here now problem and foregoing a significant royalty upstream or royalty cash flow from -- and thereby investor value going forward. So the balance has to be right to do so. And so far, we have been discussing. We have seen a number of -- not a number, we have seen a few offers where that balance has simply not been right and where I don't think any of you would praise your hand to me nor the Board if we have signed any of those agreements. But that's an ongoing discussion. Then we have a couple of questions here, one from [ Carlo ]. Yes, finding a partner to launch the Phase III study of mita is time consuming. What other opportunities do you see beyond collaborating with other biotech and pharmaceutical companies? I think that's an excellent question. And Alligator, me, Johan, the Board, the rest of the company, we are responsible. We have a responsible management, and we are stewards of mitazalimab. And even though the main focus is finding a partner, we are also developing and have developed and are maturing opportunities to maintain the momentum of mitazalimab, leveraging some of the tools that we have discussed earlier today. We are also all aware that we are a listed company. So I cannot go into detail with those plans, but we will inform you and the market promptly if either deal, of course, but also if something else materializes. But we are developing alternatives to continue bringing mitazalimab forward. Then we have a question here, runway. So this is for you, Johan. Runway is also obviously a game plan for our runway, I think, extension. It's critical beyond TO 14. And if we could elaborate a little bit on that. I don't know how much you can say, Johan, but a few words will probably be...

Yes, yes, not so much on top of what I said before around the second quarter of 2026, but also what Soren just mentioned that we are looking into options. And of course, that might include some kind of financing. So all of that as a package that we are currently reviewing and maturing. So let us come back once we have something to disclose.

And then we have a question -- last question here for now at least. Are there any potential commercialization partners discussing related to mitazalimab Phase III? That's a good question. Yes, there actually is. There is a lot of interest from commercialization partners beyond or your classical development partner. So Johan and I are, of course, entertaining these discussions. And it's maybe a little bit too early to really materialize discussions or advance discussions with this at the current stage. But yes, there is a significant interest from commercialization partners relating to mitazalimab. Good. I think that ended the list of today's questions. So unless we had -- we have one question more here. I saw that in the chat. Now it disappeared. Greta, maybe you can help us have it. So there's another one. Now they're coming in here in the 11th hour. Any sensitive goals of Phase III completion targeted? Let's start with Phase III initiation. We have a Phase III study agreed with the regulators of around 550 patients. And we expect that is a study that can be, depending on partner and depending on investment level, can be recruited in 18 to 24 months. And then you can expect a first interim analysis around maybe a year later from that at a time point where there is a real probability of approval. So approximately 2.5 to 3 years, more likely 3 years after the first patient is enrolled in the study. Then we have a couple of questions here about progress with partners. Yes. One is even asking whether it isn't better to do a bad deal than no deal? That, of course, depends on how bad it is and what the alternatives are. The only thing I can say is that we are doing the best we can as management and Board and advisers to negotiate deals with interested parties. And at the same time, as I said, we are developing alternatives that will make it easier to partner mitazalimab and still lowers the investment level needed to bring the drug forward for a partner and also maintain building value into the program. And somebody asked here, you said -- you previously said that you have advanced negotiations or advanced some of the negotiations compared to before. Can you say the same today? I can for a number of partners. It's also evident that 1 or 2 discussion partners have chosen to do other deals while since last time we had a [ Q ] call. But business development is a process that takes a long time. It's not only the day that you send out the press release. Often you have 1, 2, 3 years discussions and negotiations before that. And I would say we're still making progress in those discussions. Good. And now I can see the chat is running dry. So I want to thank you for your participation and wish you a lovely afternoon or day wherever you are in the world. Thanks a lot. Thank you.