Hello and welcome to Alligator Bioscience's interim report call for the first quarter of 2026. With me today are our CEO Søren Bregenholt and our CFO Johan Giléus.

My name is Kajsa Hæggblom, and I'm the IR and Communications Manager at Alligator, and I'm introducing this call. Today Søren 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 [email protected]. As Alligator is a publicly listed company, and I would 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 that, over to you, Søren.

Thank you, Kajsa, 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. What we will focus on today is some of the key updates.

If we look at our lead asset, mitazalimab, we presented and discussed the final data from the Phase 2 study at at ASCO GI in San Francisco in January, which was immediately followed by by J.P. Morgan, where we had a number of partnering discussions.

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 Dutch group, data further underpinning and strengthening the mechanism of action of mitazalimab. Then, as we also are 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 mitazalimab in an investigator-sponsored Phase 3 study.

On the business side of of Alligator, the the TO 14 warrants matured, and there was an exercise rate or subscription rate of of 38%, which led to a a gross proceed of 90 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 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 a a technology that we have been using in a number of internal programs and also earlier signed an evaluation and option agreement with a a a company in the antiviral space. 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 Henlius' advancement of of HLX22.

Now let's have the next slide and focus on some of the recent development in in the world around us. I think anybody that follows follows mitazalimab, Alligator, and and pancreatic cancer is aware that Revolution Medicines announced data, or at least announced a couple of numbers in a press release on on on their KRAS inhibitor, darovasertib, in in second-line metastatic pancreatic cancer.

These data showed significant improvement for these patients, and it's clear that that this molecule will will be used in in second-line therapy in in pancreatic cancer very, very soon. Together with other molecules in this drug class, the KRAS inhibitors will most likely be be introduced in first-line therapy within the next 2, 3, 4 years.

A lot of things happening in 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 in second-line therapy.

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

Right now all we know on on these molecules is the the top-line Phase 3 data. Some data was recently released at AACR, both in in second and first line.

We will have to see at at ASCO in a month's time on how how the the the data look in in detail. 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. We believe that one or more of these will make it to the first line.

We also believe that mitazalimab has a role to play in this maturing treatment landscape, something that we will discuss in in just a second. Good news for the patients, really something that can contribute to a to a a better prognosis for those patients that have progressed on on chemotherapy.

If we take the next slide, I just wanted to remind you that that mitazalimab, in its its way of working, is complementary both to chemotherapy and and also to to KRAS inhibitors. You've already seen the data on on the left-hand side here of the graph, with a lot of very deep responses and across the two doses tested in Phase 2, actually five complete responders, which, as far as we have seen data, is not something you see neither with chemo or with KRAS inhibitors.

If you tap a couple of times, Kajsa, 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 mitazalimab and and its ability to activate the immune system is that in addition to these treatment responses and patients progressing after 6, 9 months, we have a a significant amount of patients that are seeing sustained clinical responses, sustained survival benefit with mitazalimab. As you recall, the the survival rate at 30 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, mita has has several ways of of activating the immune system, but primarily and the hallmark of of what we see linked between the mechanism of action and the long-term survival benefit is the ability of mitazalimab to activate tumors tumor-infiltrating T cells, and thereby mounting the body's own defense against against the the pancreatic tumor in in this case.

How will this play out when you combine KRAS and and mitazalimab? Do we have any evidence?

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 Alligator, but from from other researchers, from a set of publications that came out in Cancer Discovery last year.

What these 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 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 a few other small responses.

If you in the same experiment then add a CD40 molecule as surrogate of of mitazalimab, you can immediately see that the majority of mice, all mice minus one, actually have complete remission of their tumor, clearly showing a a a combined benefit of of a KRAS inhibitor and a CD40 monoclonal antibody like mitazalimab. That is further corroborated by the data in in on the right-hand side of 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, another targeted therapy, and then with with a with the same CD40 monoclonal antibody.

What we immediately see on on the tumor volume is that when you add the CD40 to either of these combinations, you completely eliminate the tumor. You can see the the slim blue lines here close close to zero.

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 on survival. When you add the CD40 molecule to this combination, i.e.

allow the immune system to attack the tumor, then you suddenly have a significantly protracted survival benefit in in in these models. One 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 IV metastatic cancer, side effects is also a a significant part of of your treatment selection.

What we know from the Phase 2 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 mitazalimab is compatible with the most harsh form of chemo and had allowed us to to sustain dosing in these patients for up to to 3 years.

We really believe that mitazalimab will have a a role to play on its own in first-line therapy together with chemotherapy, but we definitely also believe that mitazalimab will be a future combination agent with with KRAS inhibitors, whether it's the currently developed KRAS inhibitors or some of the ones that are currently entering Phase 3, that time has to tell. What will this mean for patients?

I'm I'm sure you can recognize this from from one of my first slides. If we look at how chemo has or how the treatment landscape in in first line has developed over the the last couple of decades, the the primary focus have been on or been developing chemotherapy, gemcitabine plus nab-paclitaxel adding a little benefit, FOLFIRINOX, as adding some more benefit.

Recently, Ipsen and Servier marketed Onivyde in NALIRIFOX, which did not really add much to the efficacy. Then now we have in 2026 the start of what I would call the doublet area or era, where we start combining drugs in first line, most likely with chemotherapy, and hopefully that will lead in 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.

Again, just to to emphasize that we believe that mitazalimab is a sublime combination partner in this in this regime. A significant progress for the patients and a maturing of of the of the of the treatment landscape.

Of course, it adds complexity to to the world that we live in, and that is a complexity that that that we are navigating as we speak. Now if we take the next slide, this is just to remind you, and and please don't go into the into the into the minor details here, but really just to take a status on where we are with mitazalimab.

We have developed the drug. We've developed all the all the non-clinical aspects of the drug.

We have, as agreed on on the clinical way forward with with regulators. We will, of course, continue our dialogue with regulators also in in light of of of the of the latest data and see if if that changes anything positive in in FDA's and EMA's paradigm.

We are evaluating the feasibility of of the Phase 3 study, both in on on a larger scale or on a macro scale and also on on individual trial sites in in the countries that we are targeting. We expect also to be able to submit the final regulatory documents sometimes during Q2.

Basically, what is ahead of us in in sort of big chunks in terms of of development is, of course, the Phase 3 study, which, if if everything holds true, we are carefully hoping to be able to start in the in the fourth quarter of this year. 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.

Then the next slide, Kajsa, is is really a reminder of of the trial design that we have discussed at this forum a couple of times, approximately 570-something patients. That we have signed a letter of intent with the French non-for-profit organization UNICANCER to to investigate the feasibility or explore the feasibility of an investigator-led study.

I think it's very important for for us here to emphasize that the study that is being explored is the study that has been agreed with FDA and EMA, 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 significant reduced cost structure while we are maintaining the submission quality. That's of increasingly or absolutely important.

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.

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 and actually reaching out to UNICANCER to to become part of this. Despite the data that we that we discussed from the KRAS inhibitors, we believe that there is still a significant interest from from investigators in mitazalimab and interest in participating in this registrational study.

With that, we we we close mitazalimab for now. I'm sure that there will be questions in the Q&A, and and we'll pick it up there again.

If I can have the next slide, just to to reiterate our our licensed molecule, HLX22. As this is a HER2 monoclonal antibody that is being developed by Shanghai Henlius in in China.

Alligator has a a a financial interest in in the molecule. We believe that that can, in in a conservative way, lead to a net inflow of of between $15 and $40 million US dollars annually approximately from 2030.

I think it's fair to say that that that potential value is not is not reflected in in Alligator's market cap, but that's that's another story. There's a Phase 2 the Phase 3 study going in in pancreatic cancer—not in pancreatic cancer, in in gastric cancer.

The first data the first patient was dosed in a Phase 2/3 study in in recurrent breast cancer. 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 AbClon and and Henlius.

This data was presented earlier in in April. You can see under in the table here that that there is a number of of studies ongoing and and planned.

I think, most interestingly, Henlius has also announced the intent to start a Phase 2/3 study in neoadjuvant breast cancer, pre- pre-surgery. If we can have the next slide here, yeah.

This is just a little bit on on the data of the of the Phase 2 data underlying the global Phase 3 data, a very strong a very strong hazard ratio of 0.2 in in in this study, very, very convincing data that that leads us to believe that the probability of success in the Phase 3 study is is is relatively high. With these data, I will hand the the floor to you, Johan.

Thank you, Søren. Can we have the next slide, please?

Here's the snapshot of the Q1 results from Alligator. We have around 17 million in operating costs, and that's mainly then the general operating costs that we have within the organization.

We do have some limited initial costs for the planned Phase 3 then, but yes, small amounts then. This is also what we have expected and when we come to this level of running cost then.

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 TO 14 and also the renegotiated loan with Fenja then, and some interest costs deducted from that. Quite uneventful first quarter then.

Moving over to the next slide, please. Here you can see in the graph then how our costs has come down from an annualized level of 300 million and down to 100 here.

We're still going down then with the rolling effect and down to 15 to 20 million per quarter. That's what we expect then for the general operating costs then.

As always in this industry, the liquidity position is of our interest, and we have around 33 million in our cash account then per the end of the quarter. That provides some runway cost then for up to the mid-third quarter.

Of course, that's not good enough, and we are then looking into various options then to finance the running costs as well then, but also the Phase 3 cost. We will come back on that once we have something to communicate then.

That was a snapshot of the financial situation within Alligator. Back to you then, Søren.

Thank you, Johan. I'll turn on my camera.

Just to summarize what we have discussed today before we go to the questions. The Phase 2 trial with mitazalimab in first-line metastatic pancreatic cancer is completed.

We believe the data is very encouraging and promising, and that they warrant registrational development in first line. We're also very cognizant about that the treatment landscape is changing, and we are, of course, in the process of talking to all of our global key opinion leaders, Americans or US-based, European-based, and Asian-based, to ensure that we understand all aspects of this.

We still believe that mita needs to be developed, both as a chemo combination, but also 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 3 trial to significantly lower the cost of that trial. We already discussed the KRAS inhibitors and the fact that the preclinical data demonstrates synergies between this new class of drugs and mitazalimab.

We continue our partnering efforts as always, both with focus and diligence, and it's also clear that there's probably a new target of companies now 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 2 trial in biliary tract cancer to start as well as others during 2026.

Then HLX22 represents a potential and significant longer-term financial upside for Alligator and its investors. We discussed the Phase 2 data in gastric cancer and the ongoing Phase 3.

More clinical trials, registrational trials will start, and then we saw the convincing preclinical data presented for the new kid on the block, HLX49, which is a derivative from HLX22. With these words, I will stop for now and turn to the questions.

As always, the chat is open, and you can put in your questions there. We already have a few ones that I'll read out and answer.

There is a lot about the Phase 3 development, let's take them one at a time. Filip from Redeye asks when do we expect to finalize the feasibility assessment.

That is ongoing. We are in 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.

Then there is a couple of questions about the financials around such a Phase 3 setup from Joseph Hedden. We're not in a position to talk about that.

We don't have the final budget. Again, we're not going to communicate that before we have finalized arrangements with UNICANCER.

Then a couple of slides here or questions about how do we incorporate the understanding of KRAS, their impact on the treatment algorithm into Phase 3, potentially Phase 2 design. As I said, the industry only have a press release and a poster from AACR.

The full Phase 3 data in 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 and based on the information we have is that mitazalimab needs to be developed and approved most likely on its own account, and that's what we're doing in the current Phase 3.

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

Then in the KRAS non-G12D population, so that's the remaining around 60%, we still don't know whether KRAS will be a first-line therapy or whether it will be reserved for second line. Of course, you'll ask the question about why not put the KRAS-pan in first line.

I think there's a number of indications like renal cancer, for instance, where some of the more efficacious and 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. 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 that one drug will take everything.

There will be room for drugs like mitazalimab on its own and definitely also in future combination machines. How do we get there?

Our current hypothesis is to continue the Phase 3 development with mita and FOLFIRINOX, and then together with KRAS developers probably do some Phase 2 studies in that combination. I can see here that there is already a question here whether there is a possibility for investigator-initiated studies in the future with KRAS and—this is Sebastian from Kempen—with KRAS and mitazalimab.

Absolutely, yes, that is already being discussed. Sebastian also wonders whether the partnering discussions have changed regarding mitazalimab, given these changes.

I would say that everybody, of course, stops and take a look. We look at this as two things in two ways, and we also hear both views from investors and partners.

Some believe that the KRAS inhibitors will dominate completely. I don't personally believe that.

Others believe that the KRAS inhibitors will open up the indication and 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?

We have a question from somebody called TT. I think it is good practice to fill in your name here.

Anyway, is Moelis Bank still engaged is the question. We still have a contractual engagement with Moelis.

Then there is a number of questions about the continued development strategy of mitazalimab. Again, our current hypothesis is to develop mitazalimab together with FOLFIRINOX in a Phase 3 study as outlined, and at the same time assess its efficacy in combination with KRAS inhibitors.

How exactly that trial is or such trials are going to be designed, whether it's first line, whether it's second line, there you have to bear with me that we don't have enough detailed data to be able to assess that completely. That is something that we, of course, are discussing with our key opinion leaders and other experts, and that is something that will mature over the coming months.

I don't think we have any more questions. Should we give it one more second?

No, that seems to be the end of it. Then once again, thank you for your attention.

I hope this was useful, and have a lovely afternoon or day, depending on where you are in the world. Thank you.

Thank you.