Hello and welcome to Alligator Bioscience's 2025 Year-End Report Call. My name is Greta Høg.

I am the IR and Communications Manager at Alligator, and I will be introducing today's call. With me are our CEO Søren Bregenholt and our CFO Johan Giléus.

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 email to [email protected]. As 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, Søren.

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.

Greta, if I could get the next slide just to get going. What has happened sort of on the higher lines in the company?

We have published two exciting papers, very exciting papers on mitazalimab: all the biomarker data from the Phase 2 study and were published in Cell Reports; and also data from the REACTIV-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. I'm, of course, not mentioning these two 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 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 portfolio or IP position of yet another US patent approval on our bispecific molecule, ATOR-4066, the CD40-CEACAM5 bispecific antibody.

Then, on the HLX molecule, HLX22, Henlius received regulatory approval in China for their Phase 2/3 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.

What are the key points in Q4 was the release of or 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 2 population treated in the Phase 2 study.

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, 450 micrograms, or the high dose, 900 micrograms of mitazalimab in first-line metastatic pancreatic cancer. Even though the slide looks incredibly busy, I think there's a couple of key points that we need to take from this.

Key point number one 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 3 dose. What is equally important is that when 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.

Most notably, as you can see to the right-hand side, we actually now have additional two complete responders, now a total of five patients have complete responses to mitazalimab in this very-hard-to-treat indication. In addition to this, you can see that we have two patients with more than 80 and one of them close to 90% reduction in tumor burden.

Together, this data tells us three 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 3 dose, is better than 450, meaning that we have a clear dose response in this Phase 2 study with mitazalimab. 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 significant effect of mita on median overall survival and on the durability of response. When you look at the landmark data, as we've discussed previously, we increase the probability of being alive at 18 months by a factor of two, at two years by a factor of three, and at 2.5 year by a factor of four of mitazalimab in comparison with a chemotherapy backbone.

When we look at the combination of the clinical profile of mitazalimab with a safety profile that is consistent with mFOLFIRINOX, which allows combination with this chemotherapy and dosing for extended periods of time—we have several patients that been on the drug for more than two years and some patients even longer—when we compare that with the deep and durable responses with five patients with complete responses, 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. A strong suit 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, not to overburden you with 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 1 study done together with a 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. Again, building on the mechanistic evidence that mitazalimab is doing exactly as we want it to do in these patients.

If we then go to the next slide, and as I said, we have now completed OPTIMIZE-1. There's 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 any longer, and there will be no more data readouts. Where we will get data readouts is for the number of Phase 1 and Phase 2 studies that we have started, both in the US and in Europe, based on the very strong investigator interest in mitazalimab.

We have a number of studies that are open and recruiting, both in all the premalignancies, in pancreatic cancer, and breast cancer on a US 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 happen 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, a study, if we can have the next slide, Greta, that is basically a randomized Phase 2 study run at Institut Curie and a few other hospitals across France, enrolling 112 patients in biliary tract, randomized 2 to 1, every time there's two two mitazalimab patients, there will be one control patient, and we expect this study to start in the second quarter of this year. Biliary tract is a rare and highly lethal gastrointestinal cancer.

It qualifies for orphan drug with around 30,000 cases a year in the US and in Europe, and around 200,000 cases worldwide. The median OS remains around a year, even with approved IO combinations in first-line, hence the unmet medical need is significant, and there are really few effective systemic treatment options.

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, is also the same physicians that are treating other gastrointestinal cancers, and the activity that we have seen in pancreatic cancer together with mFOLFIRINOX have led to the conclusion that it's relevant to try mitazalimab in combination with FOLFOX, a subset of the mFOLFIRINOX frontline, FOLFOX and mitazalimab in second-line in biliary tract.

Just to remind you, the study is a randomized Phase 2 study. It gives the opportunity to actually add a Phase 3 arm if the Phase 2 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 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.

Without going too much into the financials, our conservative estimate of a potential royalty stream annually between 150 and 400 million SEK remains unchanged. I think that it's fair to say that based on the data that has been published, the progress in the Phase 3 study, I think we can say that the probability that this will materialize has increased.

Why do I say that? The Phase 3 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.

The Phase 3 study in gastric cancer is ongoing. It's a 550-patient global study.

It's based on a very strong set of Phase 2 data that I'll share you within a second. There is a breast cancer Phase 2 study ongoing that hopefully will be completed soon, if not already.

That has led to the initiation or the planned initiation of two additional studies in breast cancer: a study in a neoadjuvant setting and a study in recurrent breast cancer. You can see from the table here that Henlius expect to enroll approximately 1,500 patients across these trials.

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. 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 HLX22 data and the Phase 3 trial, I thought it would be interesting just to mention that a new molecule has materialized called HLX49, which is a bispecific antibody-drug conjugate 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, we don't really ascribe any tangible value to that in our current financial modeling. If we go to the next slide, Greta, just to sort of even the playing field here, we have the same setup of information when we talk about HLX22.

The company reported the Phase 2 data at ASCO GI in January, and you can see them in the upper left-hand corner of your screen here. Basically, what you can see is that compared to the control group, which is a complex treatment of an antibody and chemotherapy called XELOX plus/minus pembrolizumab, when you add HLX22 to that combo, that is the orange line there, you can see a very strong separation.

When you run the statistics, HLX22 actually infer up to an 80% reduction in the risk of disease progression or death, a very strong Phase 2 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 3 study. In summary, good progress on mitazalimab, which is in Alligator's control, and also strong progress on HLX22, driven by Henlius.

With those notes, I will leave the word to you, Johan.

Thank you, Søren. Can we have the, yeah, perfect, thank you.

This is a snapshot of the financials for the Q4 2025. As expected, we are seeing decreasing expenses due to the fact that we have more or less closed the clinical trial for Phase 2, 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 had done during 2025. All of that, if you're interested, you can see quite extensive disclosures in the Q4 report and previous report as well then.

If you want to dig in deeper to that, but all in all, it's mainly effects of should it go through the P&L or go directly to equity, if you want to summarize it. Can we have the next slide, please?

Here is more of an optical graph of the decreasing cost, and we are coming down to a baseline that is between 15 and 20 million per quarter in 2026 then, given that we're not doing anything additional to this baseline then. The liquidity position of the company is now 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.

Then, of course, we had some bridge financing and repayments to be made, that's why the total liquidity position is lower than the actual capital raised then. As Søren 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 then, but let us come back on that. Next slide, please.

Here we have the TO 14 in a snapshot, then. We can the maximum raise additional 61 million gross, and this is due to the quite narrow interval that we now know about for the subscription then.

It's between 20 öre and 25 öre, and we are just now in the pricing period then, we will know in a week or two then exactly the subscription price then. Of course, the uptake will determine the proceeds that we can raise.

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 good for you to know that, you at least know to act on your subscriptions or your TO 14s then. You can also then trade the TO 14, buy or sell additional TO 14s then up to 17th of March.

With that in, I think I will hand over to you, Søren, before we take any questions then.

Thank you, Johan. Just needed to get the technology to work here.

Thanks. If if I can have the next slide, I just want to reemphasize a few points: that that the Phase 2 trial in in with mitazalimab in pancreatic cancer is now completed.

We have seen unprecedented landmark survival data at at 30 months, 21% survival versus an estimated 5 for the chemo backbone, and and that very nice set of data has now sort of been been accompanied by another set of complete responders, bringing that number up to to five. It's very clear that this this data warrants registrational development in the indication.

That's not only something that that that Alligator thinks, but that is the widespread believe with our key opinion leaders both in in Europe and the US. The drug is Phase 3-ready, and we have established a regulatory path to approval.

Of course, we continue to to to speak with with potential partners about global deals and and also, in certain extents, regional deals. Then we are exploring and executing development options beyond PDAC, as we just discussed, where the most the most tangible—not tangible, it's not the right word, but sort of the most prominent now is the randomized Phase 2 study in biliary tract cancer that we expect to start in the second quarter 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 a large randomized study, really is a true development option for mitazalimab in addition to to pancreatic cancer.

Then, as we discussed, the HLX22 program developed by Henlius: strong Phase 2 clinical data in gastric cancer leading into a a global a global trial that is that is creating some attention, and and and based on the the Phase 2 study in breast cancer, we also see the clinical program expanding in that indication with two new Phase 2/3 trials in breast cancer. Then finally, I introduced you to HLX49, a bispecific antibody-drug conjugate that is partly delivered from from HLX22.

A a steady quarter rounding up a very significant year for Alligator, moving mitazalimab forward, reading out good data yet again, and closing down down the trial as as expected. As Johan just just mentioned, bringing down down the burn rate to to a relatively low level of between 15 and 20 million SEK per month per quarter.

With that, we'll we'll take a couple of of questions. Remember, you can always use the chat as as we speak.

We have a couple of of questions here from Philip from Redeye, and I can see that there there's a small a handful here. Philip writes that RAS inhibitors or KRAS inhibitors, if you will, have taken center stage in drug development in in pancreatic cancer and other solid tumors.

Philip then asked, "It seems like mitazalimab can be a useful combination partner with with these inhibitors. What are what are my thoughts, what are our thoughts on that?

Do you have any any discussions with with potential partners?" I think that's a a very timely and thoughtful question, thank you for that, Philip.

Yes, KRAS inhibitors are most likely getting approved in in second-line, probably already this year. The the leader in that drug class, Revolution Medicines, has announced that they will start a a couple of Phase 2/3 studies with their various inhibitors also in in first-line this year.

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 on the first-line on the first-line landscape, absolutely. We will see how 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 two drug classes work nicely together in in CD40 agents a CD40 agonist giving deeper and also more durable responses in in combination with with KRAS inhibitors than the KRAS inhibitors alone. That's that's clearly a yes.

We believe that mitazalimab would 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 that these drugs have a a safety profile that that allows that to happen.

Then the second part of the question is that do we have any discussions with with potential partners about that? I would say we we not only have discussions with with partners about that, but we're also talking to to a number of clinicians that that have asked themselves exactly that question that Philip has, and and and we're exploring opportunities to actually run clinical studies in in that combination in the in the IIT setup that that we just just described.

That was a long answer to 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 a gentleman called Bangsly, I know his full name, but but anyway, and we also have a question from Philip around the the the the milestone coming from or earned or to be earned from the Phase 2 study with HLX22. AbClon's CEO has has announced that he expect that milestone to be paid during first half of 2026.

I'm not necessarily commenting on on on on on his comments, but yes, that is that is definitely a a probability. I'm not going to I'm not free to let you know what what that what what amount is that that's going to be.

I can tell you, and I think I said this before, that it's it's it's relatively modest. It's based on the fact that the drug was licensed at at a very early stage, and the the clear upside to Alligator is through the eventual royalty payments.

Søren, just to add on that subject, it's also then paid once the study is completed, it has nothing to do with top line or something. It's when they complete the study.

If 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 Philip 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.

It's clear that the closer we get to readout, the potential value of a monetization will increase. For Alligator's management and board, it's really about finding the right balance: not selling the future royalty too cheaply to solve a—what can we say, I wouldn't neglect it, but a smaller here-now problem, and forgoing a significant royalty upstream or royalty cash flow from and thereby investor value going forward.

The balance has to be right to do so. Far, we have seen a few offers where that balance have simply not been right, and where I don't think any of you would praise Johan, me, nor the board if we had signed any of those agreements.

That's an ongoing discussion. Then we have a couple of questions here, one from Carlo.

"Finding a partner to launch the Phase 3 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 management, and we are stewards of mitazalimab. 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, I cannot go into detail with those plans, but we will inform you and the market promptly if either a deal, of course, but also if something else materializes. We are developing alternatives to continue bringing mitazalimab forward.

Then we have a question here—so this is for you, Johan—"Runway is short, obviously a game plan for runway, I think extension, is critical beyond TO 14. If we could elaborate a little bit on that."

I don't know how much you can say, Johan, but a few words would probably be—

Not so much on top of what I said before, around the second quarter of 2026, but also what Søren just mentioned, that we are looking into options, and of course, that might include some kind of financing. All of that, there's a package that we are currently reviewing and maturing, let us come back once we have something to disclose.

Then we have a last question here, for now at least. "Are there any potential commercialization partners discussing related to mitazalimab Phase 3?"

That's a good question. Yes, there actually is.

There is a lot of interest from commercialization partners beyond sort of your classical development partner. 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.

Yes, there is a significant interest from commercialization partners relating to mitazalimab. Good.

I think that ended the list of today's questions. We had one question more here.

I saw that in the chat, now it disappeared. Greta, maybe you can help us have it.

There's another one. Now they're coming in here in the 11th hour.

"Any tentative goals of Phase 3 completion targeted?" Let's start with Phase 3 initiation.

We have a Phase 3 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, 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. 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 advisors 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. Somebody asks here, "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 one or two discussion partners have chosen to do other deals since last time we had a Q call. Business development is a process that take 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. I would say we're still making progress in those discussions.

Good, and now I can see the chat is running dry, 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.