speaker
Greta Högdahl
IR and Communications Manager

So hello and welcome to Alligator Biosciences interim report call for the first quarter of 2026. With me today are our CEO Søren Weinholt and our CFO Johan Gillius. My name is Greta Högdahl and I'm the IR and Communications Manager at Alligator and I'm introducing this call. Today, Sören and Johan will walk you through the latest events from the quarter, after which they will be happy to answer any questions that you may have. You can either submit these via the Q&A functions of this chat, or you can email them to ir.alligatorbioscience.com. As you know, Alligator is a publicly listed company, and I would like to know that today's presentation may include forward-looking statements. Please refer to the disclaimer on this slide, which applies to the full presentation. And with that, over to you, Sara.

speaker
Søren Weinholt
CEO

Thank you, Greta. And once again, welcome to this quarterly call from Alligator Bioscience. It's a pleasure seeing so many participants. Let's go to the next slide. So what we will focus on today is Some of the key updates. If we look at our lead asset, Mr. Salimab, we presented and discussed the final data from the Phase 2 study at ASCO-GI in San Francisco in January, which was immediately followed by J.P. Morgan, where we had a number of partnering discussions. Recently, at the annual AACR meeting in 2026, um we presented data from one of the iit studies that we've been doing together with with a dodge group data further underpinning and strengthening the mechanism of action of mr salomon And then, as we're also going to discuss later today, we announced that we have signed a so-called letter of intent with a French organization called Unicancer to explore the continued development of mesothelioma in an investigator-sponsored phase three study. On the On the business side of Alligator, the TO 14 warrants matured and there was an exercise rate, a subscription rate of 38%, which led to a gross proceed of 19 million SEK. The nomination committee submitted its proposal ahead of tomorrow's AGM in nominating two new board members, adding significant skill and breadth to the alligator board. We also got a new patent granted by the USPTO on our proprietary bispecific antibody technology, which we call Ruby, a technology that we have been using in a number of internal programs and also earlier signed a evaluation and option agreement with a company in the antivirus space. And then finally, on our partner program, HLX22, the first patient was dosed in a Phase 2-3 trial in recurrent HER2-positive breast cancer, again, adding to the breadth and the commitment of Henleus' advancement of HLX22. Now, let's have the next slide and focus on some of the recent development in the world around us. I think anybody that follows the thalamus, alligator and pancreatic cancer is aware that Revolution Medicine announced data or at least announced a couple of numbers in a press release on on their KRAS inhibitor dioxanosib in second-line metastatic pancreatic cancer. These data showed significant improvement for these patients, and it's clear that this molecule will be used in second-line therapy in pancreatic cancer very, very soon. together with other molecules in this drug class, the KRAS inhibitors will most likely be introduced in first-line therapy within the next two, three, four years. So a lot of things happening in the indication. And first and foremost, this is really, really good news for pancreatic cancer patients who have progressed on chemotherapy and now have an option in second line therapy. What it also does for companies like Alligator and others developing drugs in the indication is of course that it opens up the indication. It shows that drugs can be developed after many decades of very few success stories and it will most likely drive the maturation of of both the second and first line therapy from today being chemo only or chemo almost only landscape to a landscape that will initially be dominated by doublets and eventually also by more combinations such as triplet therapies as we see in many other indications where the treatment landscape has matured. Right now, all we know on these molecules is the top line phase three data. Some data was recently released at AACR, both in second and first line. And we will have to see at ASCO in a month's time on how the data look in detail. And before we know that, it's difficult to say how will the second and first line landscape develop over the years to come. It will be probably characterized by several different KRAS inhibitors as a couple of other, both pan-KRAS and mutation-specific KRAS inhibitors in development. And we believe that one or more of these will make it to the first line. And we also believe that metazolamab has a role to play in this maturing treatment landscape, something that we will discuss in just a second. But first of all, good news for the patients, really something that can contribute to a better prognosis for those patients that have progressed on chemotherapy. If we take the next slide, I just wanted to remind you that mesosalumab in its way of working is complementary both to chemotherapy and also to KRAS inhibitors. You've already seen the data on the left-hand side here of the graph with a lot of very deep responses and across the two doses tested in phase two, actually five complete responders, which as far as we have seen data, is not something you see neither with chemo or with KRAS inhibitors. And if you tap a couple of times, Greta, on, yeah, one more, basically, yeah, you can just click forward and so we'll have all of them there. Basically, what is characteristic by mitosalumab and its ability to activate the immune system is that in addition to these treatment responses and patient progressing after six, nine months, we have a significant amount of patients that are seeing sustained clinical responses, sustained survival benefit with metazolamab. As you recall, the survival rate at 30 months was one in five patients, something you don't see with chemotherapy alone. Why is this? On the next slide, and just to repeat what we have discussed at these meetings before, META has several ways of activating the immune system, but primarily and the hallmark of what we see linked between the mechanism of action and the long-term survival benefit is the ability of mitosalimab to activate tumor infiltrating T cells and thereby mounting the body's own defense against the pancreatic tumor in this case. And how will this play out when you combine KRAS and mitocelular map? Do we have any evidence? And to get a little bit of that, we can look to the literature if we take the next piece of evidence here, which is two graphs, not from Alligator, but from other researchers, from a set of publications that came out in Cancer Discovery last year. And what these data show, if we focus on the left-hand side here, is that when you take a KRAS inhibitor that is in the orange, you get a certain number of responses in this model. You can see one mouse sort of have a complete reduction in its tumor. And at this dose, there is a few other small responses. But if you, in the same experiment, then add a CD40 molecule, a surrogate of mesacetamab, you can immediately see that the majority of mice all mice minus one actually have a complete remission of their tumor, clearly showing a combined benefit of a KRAS inhibitor and a CD40 monoclonal antibody like mitocetamol. And that is further corroborated by the data in On the right-hand side of the figure here, where a group of researchers have not only combined the same KRAS inhibitor, but also with a so-called CDK4-6 inhibitor, so another targeted therapy, and then with the same CD40 monoclonal antibody. And what we immediately see on the tumor volume is that when you add uh the cd42 either of these combinations you completely eliminate the tumor you can see the the slim blue lines here close close to zero and when you look at survival on on the other part of the graph here you can see that the small molecule or the targeted inhibitors only have a limited effect on survival, but when you add the CD40 molecule to this combination, i.e. allow the immune system to attack the tumor, then you certainly have a significantly protracted survival benefit in these models. So one of the hallmarks of combining drugs in the clinic is, of course, that you need to not only look at the combined effect of the drugs, but especially in patients with stage four metastatic cancer, side effects is also a significant part of your treatment selection. And what we know from the Phase II study is that the validated mechanism of action is linked to the long-term survival benefit. I just showed you that this is complementary to these targeted therapies. And we also know that the safety profile of metazolamab is compatible with the most harsh form of chemo and had allowed us to sustain dosing in these patients for up to three years. So we really believe that metazalumab will have a role to play on its own in first-line therapy together with chemotherapy, but we definitely also believe that metazalumab will be a future combination agent with KRAS inhibitors, whether it's the currently developed KRAS inhibitors or some of the ones that are currently entering phase three, that time has to tell. And what will this mean for patients? And I'm sure you can recognize this from one of my first slides. If we look at how chemo has or how the treatment landscape in first line has developed over the last couple of decades, primary focus have been on or been developing chemotherapy, gemcitabine, plus natpaclitaxel adding a little benefit, fulferinox as you know adding some more benefit, recently Ibsen and Servier marketed undivided NalyriFOX, which did not really add much to the efficacy. And then now we have in 2026, the start of what I would call the doublet area or era where we start combining blocks in first line most likely with chemotherapy and hopefully that will lead in a number of years to a much more developed and mature treatment landscape where patients and physicians have choices between their therapeutic regime, their combination and the timing of this, something that doesn't exist today. And again, just to emphasize that we believe that mitosalimab is a sublime combination partner in this regime. a significant progress for the patients and a maturing of the treatment landscape. Of course, it adds complexity to the world that we live in, and that is a complexity that we are navigating as we speak. Now, if we take the next slide, This is just to remind you, and please don't go into the minor details here, but really just to take a status on where we are with mitocelumab. We have developed the drug. We have developed all the non-clinical aspects of the drug. We have, as you know, agreed on the clinical way forward with regulators. continue our dialogue with regulators also in light of the latest data and see if that changes anything positive in the FDA's and EMA's paradigm. evaluating the feasibility of the phase three study, both on a larger scale or a macro scale, and also on individual trial sites in the countries that we are targeting. And we expect also to be able to submit the final regulatory documents sometimes during Q2. So basically, what is ahead of us in sort of big chunks in terms of development is, of course, the phase three study, which if everything holds true, we are carefully hoping to be able to start in the fourth quarter of this year. And then, of course, we also have some a final manufacturing validation to do sometimes after trial initiation that is needed for the ability to file your new drug application. And then the next slide, Greta, is really a reminder of the trial design that we have discussed at this forum a couple of times, approximately 570 something patients. You know that we have signed the letter intent with the French non-for-profit organization Unicancer to investigate the feasibility or explore the feasibility of an investigator-led study. I think it's very important for us here to emphasize that the study that is being explored is the study that has been agreed with FDA and EMA. So it's a study in registrational quality. It will be run at well over 100 sites across Europe and North America. It will of course provide a significantly reduced cost structure while we are maintaining the submission quality. That's increasingly important or absolutely important. And as I said, site feasibility is ongoing. There is a very strong interest from trial sites in the territories that I just mentioned. You can see it's actually a little bit the different flow. Normally your CRO reaches out to sites to gauge their interest. We now have a flow the other way. with sites learning about the study and actually reaching out to Unicancer to become part of this. So, despite the data that we discussed from the KRAS inhibitors, we believe that there is still a significant interest from investigators in metacelumab and interest in participating in this registrational study. And with that, we close Mr. Salem up for now. I'm sure that there will be questions in the Q&A and we'll pick it up there again. So if I can have the next slide just to reiterate our our licensed molecule HLX22. As you know, this is a HER2 monoclonal antibody that is being developed by Shanghai Henleus in China. Alligator has a financial interest in the molecule. We believe that that can conservative way lead to a net inflow of between 15 and 40 million US dollars annually, approximately from 2030. I think it's fair to say that that potential value is not reflected in alligators market cap, but that's another story. There's a phase two, the phase three started going in pancreatic cancer, not in pancreatic cancer, in gastric cancer. The first data of the first patient was dosed in a Phase III study in recurrent breast cancer. And then, interestingly enough, we saw the first preclinical data on a new molecule in the family called HLX49. which is a bispecific ADC incorporating, as one epitope, parts of HLX22 and is thus part of the agreement complex that we have with the Apclone and Henleus. And this data was presented earlier in April. And you can see in the table here that there is a number of studies ongoing and planned. I think most interestingly, Henlius has also announced the intent to start a phase 2-3 study in neoadjuvant breast cancer, so pre-surgery. If we can have the next slide. slide here. This is just a little bit on the data of the phase two data underlying the global phase three data. So a very strong has a ratio of 0.2 in this study. Very, very convincing data that leads us to believe that the probability of success in the phase three study is relatively high.

speaker
Søren Weinholt
CEO

So with this data, I will hand the floor to you, Johan.

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