Alligator Bioscience (Stockholm:ATORX) Q1 2026 Earnings Call

0:00 So hello, and welcome to Alligator Bioscience's interim report call for the first quarter of twenty twenty six. With me today are our CEO, Saron Reinholdt, and our CFO, Johan Gilius. My name is Kjeta Hergdorf, and I'm the IR and communications manager at Alligator, and I'm introducing this call. Today, 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 and A functions of this chat or you can email them to iralligatorbioscience dot 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.

0:55 Please refer to the disclaimer on this slide, which applies to the full presentation. And with that, over to you, Sare. Thank you, Keita. And once again, welcome to this quarterly call for Medicator 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, miseldimab, we presented and discussed the final data from the phase two study at at ASCO GI in San Francisco in January, which was immediately followed by by JPMorgan where we had a number of partnering discussions.

1:44 Recently, at the annual AACR meeting in 2026, we presented data from one of the IIT studies that we've been doing together with with a a Dutch group data further underpinning and strengthening the mechanism of action of metasalumab. 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 metazolumab in an investigator sponsored phase three study. On the business side of of ATTICATOR, the t o 14 ones matured, and there was an exercise rate or subscription rate of of thirty eight percent, which led to a gross proceed of 19,000,000, sick.

2:46 The nomination committee submitted its proposal ahead of tomorrow's AGM, in, nominating two new board members, adding significant skill, and breadth, to the to the Alligator board. We also got a new patent granted by the US PTO 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 evaluation and option agreement with a company in the antiviral space.

3:34 And then finally, on our partner program HLX 22, the first patient was dosed in a phase two three trial in recurrent HER two positive breast cancer, again, adding to the breadth and the commitment of Helios 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 metasalumab, 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, daraxanosib, in in second line metastatic pancreatic cancer. These data, showed significant improvement, for these patients, and it's clear that that this molecule will be used in second line therapy in pancreatic cancer very, very soon.

4:49 And 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. 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, like Alligator and and others, developing drugs in the 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 both the second and first line therapy to today from today being chemo only or chemo almost only landscape to a landscape that will initially be dominated by doublets and eventually also more combinations such as triplet therapies as we see in many other indications where the treatment landscape has matured.

6:15 Right now, we know on these molecules is the top line phase three data. Some data was recently released at AACR both second and first line. And we will have to see at at ASCO in a month's time on how how the the the data look in in detail. And before we know that, it's 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 of other both pan KRAS and mutation specific KRAS inhibitors in development.

7:05 And we believe that one or more of these will make it to the first line. And we also believe that metasalumab 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, that misasalumab in way of working is complementary both to chemotherapy and also to KRAS inhibitors.

7:51 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, Keita, on on, yeah, one one one more, basically, yeah, you can you can just click forward and and so we'll have all of them there. Basically, what is what is characteristic by by mitosalumab and 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 metazolumab.

8:58 As you recall, the the survival rate at thirty months was, one in five patients, something you don't see with with chemotherapy alone. Why is this? On on the next slide, and and just to repeat, what we have discussed at these meetings before, Meta has has several ways of of activating the immune system, but primarily the hallmark of of what we see linked between the mechanism of action and the long term survival benefit is the ability of metazolumab to activate tumors, tumor infiltrating T cells and thereby mounting the body's own defense against the pancreatic tumor in this case.

9:54 And how will this play out when you combine KRAS and mitazalumab? Do we have any evidence? And to get a little bit of that, we can look to the to the literature if we if we take the next, piece of of evidence here, which is, two graphs, not from ATTICATOR, but, from, from other researchers, from a set of publications that came out in cancer discovery last year. And what these page what what these data show if we focus on 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.

10:47 And at this dose, there is a few other small responses. But if you, in the same experiment, then add a c d 40 molecule, a surrogate of misoceleimab, you can immediately see that the majority of mice, all mice minus one, actually have complete information of their tumor, clearly showing a combined benefit of a KRAS inhibitor and a CD40 monoclonal antibody like metasatlimid. 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 CDK4six inhibitor, so another targeted therapy and then with the same CD40 monoclonal antibody.

11:56 And what we immediately see on the tumor volume is that when you add the CG40 to either of these combinations, you completely eliminate the tumor. You can see the slim blue lines here close to zero. And when you look at survival on the other part of the graph, you can see that the small molecule of the targeted inhibitors only have a limited effect on on survival. But when you add the c g forty 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.

12:47 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, with stage four, metastatic cancer, side effects is also significant part of your treatment selection. And what we know from the phase two study is that the validated mechanism of action is linked to the long term survival benefit. Just showed you that this is complementary to these targeted therapies. And we also know that the safety profile of metazolumab is compatible with the most harsh form of chemo and had allowed us to sustain dosing in these patients for up to to three years. So we really believe that metazolumab will have a a role to play on its own in first line therapy together with chemo therapy.

13:46 But we definitely also believe that metasalumab 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, the primary focus have been on developing chemotherapy, gemcitabine, plus, Nabpact, TEXL adding a little benefit, FOLFERINOX, as you know, adding, some more benefit.

14:40 Recently, Ipsen and Seffier marketed Omnivyde and the Lyrifox, which did not really add much to the efficacy. And then now we have, in 2026, the start of what I would call the doppler area era where we start combining drugs 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 metazolumab is a supreme combination partner in this regime.

15:43 So, 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 nisazolumab. We have developed the drug. We have developed all the nonclinical aspects of the drug. We have, as you know, agreed on the clinical way forward with regulators.

16:37 We will, of course, continue our dialogue with regulators also in light of the latest data and see if that changes anything positive in FDA's and EMA's paradigm. We are evaluating the feasibility of, of the phase three study, both on a larger scale or a macro scale and also on individual, trial sites in in the countries that we are targeting, and and we expect also to be able to submit the final regulatory documents, sometimes during q two. So, basically, what is ahead of us in in sort of big chunks in terms of, of development is, of course, the phase three study, which, if if everything goes through, we are carefully hoping to be able to start in the in the fourth quarter of this year.

17:42 And then, of course, we also have some final manufacturing validation to do sometimes after after trial initiation, that is, needed for the ability to file your new drug application. And then the next slide, Claire, is is really a reminder of of the trial design that we have discussed at this form a couple of times. Approximately, 500 and, 70 patients. You know that we have signed a letter of intent with the French non for profit organization UniCancer to investigate the feasibility or explore the feasibility of a investigator led study.

18:33 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 a 100 sites across Europe and North America. It will, of course, provide a significant 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 from trial sites in in the territories that I just mentioned.

19:24 You can say it's actually a little bit the the 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 is still a significant interest from investigators in metsarzalumab and interest in participating in this registrational study. And with that, we close missoselumab for now. I'm sure that there would be questions in the q and a, and and we'll pick it up there again.

20:16 So if I can have the next slide just to to reiterate our our licensed molecule HLX 22. As you know, this is a HER two monoclonal antibody that is being developed by Shanghai Hetlioz in in China. Alligator has a financial interest in in the molecule. We believe that that can, in in conservative way, lead to a net inflow of between 15,000,000 and $40,000,000 annually approximately from 2030.

21:02 I think it's fair to say that that that potential value is not reflected in Alligator's 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 twothree 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 HLX-twenty two and is thus part of the agreement complex that we have with app clone and Hentlius.

21:59 And this data was presented earlier in April. And you can see in the table here that there is a number of of studies ongoing and and planned. I think most interestingly, Henleus has also announced the intent to start a phase two, three study in neo adjuvant breast cancer, so pre pre surgery. And if we can have the next slide here. Yeah. This is just a little bit on on the data of the of the phase two data underlying the global phase three data. So a very strong, a very strong, hazard 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.

23:09 So with these data, I will hand the floor to you, Johan. Thank you, Sarah. And can we have the next slide, please? So here's the snapshot of the Q1 results from Alligator. And, we have around $17,000,000 in operating cost, and that's mainly then the general operating cost that we have within the organization. And we do have some limited initial cost for for the planned phase three then. Yes, small amounts then. And and this is a is also what we have expected and when when we come to this level of of of running cost then. And as we had in previous periods also, we have a number of non cash and cash items within the financial items that stems back from the TU 14 and also the renegotiated loan with Fenya then and some interest cost deducted from that.

24:08 So quite uneventful first quarter then. Moving over to the next slide, please. And here you can see in the graph then how our, you know, cost has come down from an annualized level of 300,000,000 and down to 100 here, and we're still going down and with the rolling effect and down to 15 to 20,000,000 per quarter. That's what we expect them for the general operating cost on it. And as always in this industry, the liquidity position is of our interest, and we have around 33,000,000 in in our cash account and per the end of the quarter, and that provides some runway cost then for up to the mid mid third quarter. And, of course, that's not good enough, and we are then looking into various options then to finance the running cost as well then, but also the phase three cost, and we will come back on that once we have something to to communicate them.

25:02 So that was a snapshot of the of the financial situation within Alligator. So back to you then, Soren. Thank you, Johan. I'll turn off my camera. Yeah. So just to summarize what, what we have, what we have discussed today before we go to the questions. The phase two trial with nisazolumab in first line metastatic pancreatic cancer is completed. We believe the data is relatively not relatively, very encouraging and and promising and that they want registrational development in in first line. We're also very cognizant about that the treatment landscape is is is changing.

25:51 And we are, of course, in the process of talking to all of our global key opinion leaders, Americans, US based, European based, and and Asian based to ensure that we understand all aspects of this. We still believe that META needs to be developed both as a chemo combination, but also as a as a KRAS combination partner. We have agreed the regulatory path to approval in first line. As we already discussed, we've signed the letter of intent with UniCancer to explore an investigator sponsored Phase III trial to significantly lower the cost of that trial. And we already discussed the KRAS inhibitors and the fact that the preclinical data demonstrates synergies between this new class of drugs and nivituximab.

26:57 We continue our partnering efforts as as always, both with focus and and diligence. And it's also clear that there's probably a new target of of companies now that that are interesting for Alligator, namely the companies developing second, third, or fourth KRAS inhibitor in line who may need something to differentiate their drug once it gets to the later stage of development. As we also discussed previously, a number of development options beyond pancreatic cancer is being explored, and we expect the randomized phase two trial in biliary tract cancer to start as well as others during 2026.

27:58 And then HLX22 represents a potential and significant longer term financial upside for Alligator and its investors. We discussed the phase two data in pancreatic cancer and the ongoing phase three. More clinical trials, registrational trials will start. And then we saw the convincing preclinical data presented for the new kid on the block HLX 49, which is a derivative from HLX twenty two. And, with these words, I will stop for now and and turn to, turn to the questions. And as always, we have the chat is open, and you can put in your your questions there.

28:59 We already have a few ones, that that I'll read out and and and answer. There is a lot about phase three development, so, so let's let's take them one at a time. Philip from Redeye asked when do we expect to finalize the feasibility assessment that is ongoing. We are parallel, of course, negotiating a contract, and we expect that to be finalized within relatively short. And will notify the market together with UniCancer when that is the case.

29:50 Then there is a couple of questions about the financials around such a phase three setup from Josef Hedden. We're not in a position to talk about that. We have the final budget. And, again, we're not going to communicate that before we have finalized the arrangements with UniCancer. Then, a couple of slides here or questions about how do we incorporate the understanding of KRAS, their their impact on the treatment algorithm into, into to phase three, potentially, phase phase two design.

30:53 As I said, we of the industry only have a press release and a poster from AACR. The full phase three data and second line therapy will be announced at ASCO in around a month, and then data will come as trials are reporting data. For Alligator, the current hypothesis based on the information we have is that nisazolumab needs to be developed and approved most likely on its own account, and that's what we're doing in the current phase three.

31:43 We still believe that there will be a population of patients that that are that will be treated with with chemo and metazolumab. If we go a little bit deeper in into the dialogue about KRAS inhibitors, we have a hypothesis that the G12D specific KRAS inhibitors will probably be be combined with chemo, and we believe that rituximab in that combination with a D specific chemo and rituximab is is clearly a population that that is that is targeted by by us and that would, of course, be facilitated by an approval of of metazolumab.

32:34 And then in in in the KRAS non G12D population, so that's the remaining around sixty percent, we still don't know whether KRAS will be first line therapy or whether it will be will be reserved for second line. And, of course, you'll ask the the question about why why not put the KRAS pen in in first line. I think there's a number of indications like renal cancer, for instance, where some of the modifications broadly specific drugs are kept in second line as a long stop if you may once the patients have progressed on some of the more specific therapies.

33:31 So what I'm trying to say here is that the treatment landscape is changing, no doubt about it. Nobody can, based on the available information, really judge how it will be in detail. I don't believe in that one drug will will take everything. There will be room for drugs like metazolumab on its own and definitely also in in future combination machines. How do we get there? Our our current hypothesis is to continue the phase three development with meter and and for Furinox and then together with KRAS developers, do some some phase two studies in in that combination.

34:27 And I can see here that there is already a a question here whether there is a possibility for investigator initiated studies in the future with KRAS, and and this is Sebastian from from Kempen with KRAS and mitsazolumab. And absolutely, yes, that is already being discussed. Sebastian also wonders whether the partnering discussions have changed regarding nitsasalumab given these changes. I would say that that everybody, of course, stops and and take take a look. I look at and we look at this as two thing in two ways, and we and we also hear both those views from from investors and partners.

35:18 Some believe that the KRAS inhibitors will dominate completely. I don't personally believe that. And others believe that the KRAS inhibitors will open up the indication and make make a more mature treatment or facilitate a more mature treatment landscape with double and triple combinations going forward. Do we have? Any more questions?

36:06 Yeah. We we have a question for somebody called GT. I think it is good practice to fill in your name here. But, anyway, is is more of these banks still engaged is the question. We still have contractual engagement with with. Yeah. And then and then there is a a number of of of questions about the the continued development strategy of of metasalumab. And and, again, our current hypothesis is to develop metasalumab together with FOLFERINOX in a in a phase three study as as outlined and at the same time assist its its efficacy in combination with KRAS inhibitors and how exactly that trial is or such trials are going to be designed, whether it's first line, whether it's second line, that that you have to to bear with me that that that we don't have enough detailed data to be able to to assess that completely.

37:30 That is something that we of course are discussing with our key opinion leaders and and other experts. And and that is something that will mature over the coming months. I don't think we have we have any more questions. Should we give it one more second? No. That seems to be be the end of it. Then once again, thank you for your attention. I hope this was was useful, and have a lovely afternoon or day depending on where you are in the world.

38:19 Thank you. Thank you.