Hello everyone, and welcome to Alligator Bioscience's third quarter 2024 interim report call. My name is Greta Höög. 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 third quarter and the upcoming news flow, after which they will be happy to answer any questions you might have. These answers you can place in our Q&A, and we will take them at the end of the call. Now, before we begin, I would like to share a quick reminder with you that during today's call, management may make forward-looking statements that involve known and unknown risks, uncertainties, and other important factors beyond the company's control that could cause the company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. This call is being webcast and will be made available through our investor relations section of our website. With the formalities out of the way, I would now like to turn the call over to Søren. Thank you, Greta, and welcome to the call to everybody. Also, first, before we dig into today's call, I wanna welcome Johan Giléus as Alligator's new CFO. It's a pleasure to have this first call with Johan, who assumed the role in Alligator during August. A formal welcome to you, Johan, and we will hear much more from you later in the call. If we go to the next slide, please. This is to remind you all that Alligator's primary priority is mitazalimab. We have shown outstanding phase II results that definitely justify the further investments to maximize both patient and shareholder value in the program and in Alligator. And we will look a little bit closer to the activities and these data later on. And that being said, I also want to remind you that we have upcoming warrants in the TO9 series with a subscription period in December. Johan will take you through the details of that towards the end of today's call. So with that out of the way, let's move to the next slide, please. If we take a brief look at the pipeline, and you know that Alligator's pipeline is somewhat larger than this, today we will focus on mitazalimab, our phase II program in first-line pancreatic cancer. Although we have not provided a follow-up data since the summer, I think I have a few additional details that we want to share on how the study is progressing and some of our other preparation activities. 4066, our CD40 bispecific molecule, continues to impress us in the preclinical data that we see from the molecule. We will present some of that data in the US in a couple of weeks at the annual SITC meeting. We look very much forward to that. 4066 continues to mature as a follow-up molecule to mitazalimab in a broad array of indications. And then you're also all aware that we have a phase I program, a bispecific antibody called 527, that we are co-developing with U.S. Aptevo. There we have promised you to provide updated phase I study data during this quarter. We will do so, and we will also present data at the aforementioned SITC conference in the beginning of November. So 527 is also progressing towards phase I readout. Could we have the next slide, please? So we need to remind ourselves that in mitazalimab we have a drug that is making significant differences for patients with first-line metastatic pancreatic cancer. Those of you who are following the company and following these calls-... Recall that for 80% of patients with this disease, chemotherapy today is the only option. Drug approvals have been scarce and few between. The latest was the approval of a new chemotherapy by Ipsen that came out last year, got approved last year. We see that molecule as a molecule similar to FOLFIRINOX, where Alligator is developing mitazalimab. And if we just look at some of the key data here, mitazalimab is together with FOLFIRINOX in the OPTIMIZE-1 study, giving a response rate that is on par with, if not better than what we see with both FOLFIRINOX and the newly approved chemotherapy regimen. But where we really see a differentiation of this combo therapy over over single single chemotherapy, is in the durability of response, namely, how long do the patients actually have a clinical response before the tumor starts to regrow? And as you can see here, the median is 12.6 months for mitazalimab in combination with chemotherapy. That is, of course, in itself impressive, as we can see that the other chemotherapies have between five and seven months on their own. So a significant increase here. The key question is, of course, does this durability of response translate into survival benefits? As we have reported before and discussed, we can actually see that in OPTIMIZE-1, we at least add close to to four months of additional median overall survival. And as we'll see in a second, this is data that is on the median. But when we look at the patients in long-term treatment, we see an even greater response to the drug and a sort of even greater survival benefit. And I think it's also worth mentioning here that the durability of response for mitazalimab in combination with FOLFIRINOX is actually longer than the overall survival, the median overall survival of the chemo regimens on their own. Now, importantly, of course, when you are treated with a drug, does it also help you to live longer? One very central estimate here is the eighteen-month overall survival rate, so how many of the patients are alive after eighteen months of treatment, and we can see that the FOLFIRINOX, which is the comparator and the combination agent in OPTIMIZE-1, there you have an eighteen-month OS rate of 18%-19%, meaning that 19 out of 100 patients are actually alive after eighteen months. When you then get on mitazalimab plus FOLFIRINOX, that number increases to 36%. And so almost a doubling of your eighteen-month survival probability, which we believe is a meaningful and significant clinical benefit for these patients. Now, if we go to the next slide, we can take a little bit deeper look on how does this actually reflect in tumor size and tumor reduction in the patients treated with mitazalimab in combination with FOLFIRINOX. And if we look at the left-hand side of the graph here, you can see all the individual patients in the trial, and the bar represents how much that tumor has been reduced upon treatment. You can see that there is quite a number of patients that are green, meaning that they have had a response of more than 30% tumor shrinkage on two successive visits in the clinic. These are the so-called confirmed responders, and that is around 40% in this trial. You can also see that there is a number of patients that are orange, but where their best response is or crosses that line of 30%. These patients are so-called unconfirmed responders because they-- this was a single incident. But these patients are important because these are the patients that will be deemed responders in a randomized phase 3 trial. You can see all the orange patients have what we call stable disease, and if you add the orange and the green, then you have what we call the disease control rate, which is around 80% in this study. Meaning that 80% of the individuals or the pancreatic cancer patient receiving mitazalimab and FOLFIRINOX will have some sort of clinical benefit. Now, importantly, if you look to the right-hand side of that graph, you see three patients where the graph reaches minus 100. This represents three patients that have complete remission of their target lesions, meaning that their liver mets, lung mets, metastasis, the pancreatic tumor had all disappeared. This is a remarkable set of data in this kind of disease, which is fast progressing and very hard to treat. Now, if we look a little bit closer into some of the data behind the scenes here, we, when we look at the trial, remember we completed enrollment 19 months ago in March last year. We still have 16 patients out of the 57 that are alive on the study, meaning that they have been alive more than 19 months. Remember that the median overall survival for chemotherapy alone was 11 months. Here we have 16 patients that are still alive on the study, and we have many more patients that have been that are no longer in the study, but that has crossed that that 11-month line, of course. Also, remarkable is it that we have six patients now that remained on the study for more than two years. And we have two more patients that are at around twenty-three and a half months that will cross that important twenty-four months time point during November. And having eight out of fifty-seven patients that have been alive for more than two years in a study like this is simply unprecedented. And together, these data with the tolerability profile that we reported previously really puts an emphasis on why mitazalimab needs to be developed to benefit patients with the first-line metastatic pancreatic cancer. Now, let's take a look at one of these patients and actually look at a little bit of a patient case here. This is one of the patients from the study. A female patient presenting in the clinic in September 2022, with a combined or total tumor volume of more than one hundred and twenty millimeters, or a tumor diameter of one hundred and twenty millimeters. You can sort of do a little trick with your thumb and your index finger and see that's actually quite a lump of tumor, both in the pancreas, and as you can see here on the CT scan to the left, also a significant liver metastasis. This is a very poor prognosis to be in, and if you look on the second scan, almost around a year later, there is absolutely no tumor present in the liver anymore, so a remarkable result, which is, of course, also reflected in the sum of the tumor diameters, as you can see on the top right-hand corner here. You can see the patient presented with around one hundred and twenty, one hundred and thirty millimeters of tumor diameter. You can see, as you normally see with chemotherapy, that the first time point of treatment had a significant reduction in tumor volume through a combined effect of chemo and mitazalimab. And then the patient, which is remarkable here, stays at a very, very low tumor volume for quite a long time, until on day 350, so almost a year later, you can see that the tumor is reduced to absolutely zero. This is, of course, fantastic. The patient stayed on drug for two years, which is also remarkable. And then, of course, we also need to talk about quality of life for these patients. These patients have a lot of pain. They have a lot of side effects based on the chemotherapies that they get. If you look at the number of medications that this patient got at the start of treatment, you can see three different medications for tumor pain, four for nausea and vomiting, and five for other side effects from FOLFIRINOX. You can see when the patient came back a year later, that the total of I think it's twelve concomitant pain medications had been reduced to two. This reflects not only that mitazalimab in combination with FOLFIRINOX has a very potent effect and clinical benefit. It shows us that mitazalimab is able to allow the doctors to reduce chemotherapy while maintaining a clinical response, and that we can generally improve the quality of life for these patients that have a very lethal and disabling disease. Data like this, data like what I just showed you before, is really the reason why I care, Johan, who is on the call, and all the other colleagues in Alligator, that's why we show up at work every day, to bring mitazalimab forward to these patients as fast as possible. And this is why we believe that mitazalimab needs to be continued in a randomized confirmatory trial, preferably with a big international partner. With those words, these encouraging results, I will leave the word to Johan, who will take us through the numbers. Johan? Thank you, Søren. And I would like to start with express my gratitude to Søren and the team, and for the warm welcoming to me when I joined Alligator, and also look forward to the collaboration going forward with the entire team here at Alligator. Can we please change the slide? The Q3 results. Let's start with the sales. We actually report some sales, not as much as previous year, but at least we do some collaborative work during this quarter and the next quarter that generates certain cash inflows. And when it come to cost side, then of course, we generate quite a lot of costs still on the clinical trial, even we now see less of that, given the fact that we have stopped recruitment. As Søren said previously, we are still have patients in the trials, and that, of course, generates certain cost, which we're glad to see that the patients are still in the study, of course. On top of that, we are devoting some of our cash then to phase 3 enabling activities, which is very important to keep the development going and also, you know, prepared for the, for the upcoming phase then. And that, of course, incurs some certain costs, but it's also key for us then to stay on the critical path then to be able to, you know, take this into the next phase. And in addition, of course, we have a general operating cost and cost for the discovery units, et cetera. So that you can see down to the right in the graph, then that, of course, we spend most of our money on mita, 65%. And on top of that, we have a couple of other collaborations that we have presented. And then, as I said, the discovery unit has some 9% of the cost, and when we split out the people and the costs on these different functions then. And the general OpEx is around 18%, and we have around 47 people, and that's the latest count. So please, Greta, can you go to the next slide? So when we look at our operating cost on the rolling twelve months, we can then see that we have a downward trend, which is expected, and that will continue for a while. Then we will, of course, generate costs for this phase 3 enabling activities during Q4 and onwards. The trend should at least not go stable or downward trend, and that depending on what we decide to do. Another thing that you all investors will look at is the cash position. We have SEK 48 million in cash as of the end of September, and that is after we have taken the second tranche of the Fenja facility that was raised during the summer. This is a cash position that needs to be topped up, and the board and management are working very hard on that and look at different avenues for raising additional cash to be able to continue. I will come back to the warrants that which is part of that strategy for us. Let's move to the third slide then, please. The warrants, as you may recall, we issued units in Q1 2024, and part of that was these warrants, TO9. The subscription period now starts in December, but prior to that, we need to have a pricing period. This comes with the technical, but during November fourth to twenty-ninth, there will be this volume-weighted average price that will be generated, which will then be the basis for the pricing of the warrants with a 10% discount on top of that. We have around 100 million warrants outstanding, and there, if you do the simple math, then the current trading price, approximately 1.22 SEK, sorry, and then take 90% of that, you will, we will generate around 100 million SEK to the company. That, of course, if everyone utilizes their warrants. This is one of the reasons why we bring this up, that because you, as an investor, need to understand that this is something that you need to act on if you are a holder of the warrants. Either you then exercise them, or you can also then, on the market, divest your warrants if you're not prepared to, or various reasons, then want to exercise the warrants. But please make sure that you utilize your right here in a proper way then. We will come back to this in a different settings then to make sure that everyone understands this then. But also be very careful around the timing of different things then, because the custodians have different rules and regulations that is maybe not exactly the ones that we have presented here. These are the more general ones that the program is structured around. I think I end there, and then back to you, Søren. Thank you, Johan. Should we see what's on the next slide here? So as Johan said, we are working dedicated on preparing mitazalimab for phase 3. And let me reemphasize that, in parallel with that, we are talking to a number of global pharma companies on the potential to license and develop mitazalimab. These are discussions that we've had for some time now. Some have dropped off, others we are continuing our dialogue with, and also new companies have appeared in the data room based on the data that we released in June. The activities that are going on in the company is that we have completed the manufacturing development for phase 3. Not something that may be very sexy, and something that we very often do not talk about, but an important milestone in keeping momentum towards the phase 3 trial, and we are engaging with the European and U.S. regulators, both on manufacturing, but most importantly, also on phase 3 protocols and how that study will look, and if we look at the news flow that we will see in the next coming quarters here, I already promised you that we will show top line data from the phase one study with 527 during this quarter. We will get a glimpse of that at SITC in a couple of weeks, but the final data is most likely available during December. Then during Q4 and early into Q1, we will continue our discussions with U.S. and European regulators on mitazalimab, very important discussions. Here the idea is, of course, to create a phase three study that has the right balance of feasibility and probability of success, finding the right number of patients. We're not in a position to discuss this in detail, but we'll of course be able to share that later once we've had the final outcome of our dialogue with the FDA. Importantly, mid Q1, we expect to announce 24-month follow-up data with the 900-microgram cohort, so the main cohort in OPTIMIZE-1. 24-month follow-up is not something you normally see in first-line metastatic pancreatic cancer, simply because the numbers of patients are so small. As I already alluded to, we have a significant number of patients in OPTIMIZE-1 that actually make a 24-month follow-up meaningful and also significant. We look very much forward to share this data with you in mid-Q1. At the same time, with that, we will announce the top-line data for the 450-microgram cohort. Those of you who follow the company closely and have a good memory will recall that instead of being asked to do a phase 2b study to qualify the final dose for the phase 3 study, the FDA asked us to do a few more patients on a lower dose, the 450 microgram, that we had originally dosed five patients with in the start of OPTIMIZE-1. So this is something we need to do to fulfill regulatory requirements. We've had European authorities to approve of the concept or the approach as well, but it allows us then to move into phase 3 without having to do a big, long, and expensive phase 2b study. If and when all this comes together, and very much preferably with a partner, we believe that this will allow us to initiate phase three towards the very end of the first half next year. So all in all, mitazalimab is Alligator's key priority. We continue to deliver significantly differentiated data from the study. We continue to make big strides in getting ready for phase three, and we continue our engagement and dialogue with global pharma to find the right partner for mitazalimab that is willing to invest what it takes to develop mitazalimab in pancreatic cancer and hopefully beyond, and who is also the right partner to provide a commercial benefit short to mid-term for Alligator. So what if we take the next slide, what does the future look like? Again, twenty twenty-four comes to an end, so let's look at twenty twenty-five. I mean, key priority is, of course, to find a partner, start mitazalimab, phase three. We want to go beyond CD40 with 4-1BB and not only report the top line data from five two seven, but actually also be able to continue that study should the data be, or take the next phase in the development, should the data from that phase one study be warranting that. And then we will continue to deliver on our partnerships. We will continue to broaden our pipeline beyond 2025, and most importantly, with the current development plans and outline of phase three timelines, we believe that mitazalimab can be expected to be approved by 2030 and potentially before. The phase three design will of course entail an interim analysis that may allow early approval. So full speed ahead on our key priorities. With the next slide, I think we will come to the Q&A. I don't know, Greta, we have a couple of questions coming in here, and I think we should just take them as we used to do. So we have a couple of questions here. First and foremost, here from Richard, from Redeye. "How is the work going on the phase 3 study protocol? Do you need the results from the 450 microgram cohort to finalize it?" I think that's a very important and relevant question. We are moving forward with all the preparations for phase 3. And with the protocol, yes, we don't necessarily need the 450 data to finalize the protocol. But of course, we need to have that data to pick the and agree the final dose with the FDA before starting the phase 3 study. And as I said, we expect to deliver that data mid Q1, enabling a late H1 start of the phase three. "And what remains to be done before we start phase three?" Is another study or another question from Richard. I think we already touched upon that. A lot of big things needs to be done. We are working on that. Number one is, of course, we want to get a partner to help us with that. We need to invest some money in manufacturing, getting the material actually ready for the study. There's many bits and pieces that needs to be done that we are working on. Then there is a number of questions also from Richard here. "When can you... When do you think you can have a partner in place?" We also have a question from another investor here, who says that we previously projected that we would get a deal for mitazalimab this quarter. Now we are in October, so or in last quarter, now we're in October, so we obviously didn't get the deal. I can say we are working hard on it. I think that, realistically speaking, we probably have to move into Q1 next year. We have additional data coming out. Some of the questions that some of the top prospects of partners have asked for is: How does the 450 data look like? Have you agreed on those with the FDA? How does the phase 3 protocol look like? Have you agreed a protocol with the FDA? And therefore, I think some of this will be basing a projection of a deal in Q1. Of course, later than we would have had hoped for, but I think it reflects the current environment. And then we have the last question here from Richard, that goes a little bit on 527. If we could comment on the financial situation of our partner, Aptevo Therapeutics, and their market cap, which is pretty low, and what happens if they go bankrupt? I mean, first of all, I would not really speculate on their financial situation. They have been able to raise capital. They have... Although I don't know the amount of money, they have income from legacy products. So I don't think Aptevo will be close to bankrupt within my knowledge at least. And what happens if the drug, if Aptevo goes bankrupt? Basically, the drug would return to Alligator. I can only say that that could maybe be a little bit complicated with the U.S. Chapter Seven. But our current dialogue with Aptevo, and we speak quite a lot with Aptevo, there is no indication that we get into such a scenario. Then we have a few more questions. There's also a couple of questions on the finance, but let's take these questions on the pipeline first here. There is a couple of questions from Sweden here. There are three. Regarding the dose optimization cohort, can you remind us how many patients and when you expect to disclose the selected dose for phase 3, and what are the exact endpoint that the FDA will look at?" That's a very good question. So we agreed with the FDA that the dose optimization cohort should have around 20 patients. We have now dosed five patients in the first part of the OPTIMIZE-1 study, and we have now dosed approximately 16 or 17 patients, so we'll be around 20, 21, 22 evaluable patients. The FDA has not asked us to look at survival endpoints, but rather look at pharmacology and what we can say dose effect or dose response a relationship with that. And that's it. We are pretty confident that 900 microgram per kilogram will be the dose. We will, of course, do the study, and we are, of course, as a company, also interested in finding the right dose. And when can we have that right dose? As I said, we will read out the study in mid Q1, and then it probably takes a couple of months to do the analysis, so we will have that data and that dialogue early Q2. Can you provide an indication of the cost of running a phase 3 study in first-line metastatic pancreatic cancer? How many patients do you plan to enroll, and have you already discussed a potential phase 3 design with the FDA? We estimate a cost of approximately $150,000 for patients in a study like this. I think that's pretty standard. These studies enroll pretty quickly. Of course, it has to be a global study to support a global approval. I would say we have of course discussed potential design with the FDA. I think where we are now as a company is that we need to find a design that is a little bit more smart than just running two parallel randomized cohorts. We are looking into various designs and see how we can bring the number of patients down, and therefore also the cost down, without compromising the statistical likelihood that the study will be positive. That is really what is going on right now. Can you provide some insights on how you are thinking about capital allocation towards mitazalimab over the partner programs? That's number one question, and then, of course, there are several others that are asking what the current cash runway is. Johan, I've been speaking quite a lot now, so I think I will let you comment on those two questions. Thank you, Søren. When it comes to the allocation of capital, I think it's quite obvious when Søren has spoken about the mitazalimab, that mitazalimab is the highest priority, both, I mean, in the as the lead project, but also in terms of, you know, investing money in phase 3 preparations that will drive certain costs there in Q4 and onwards. So that's the first one. When it does come to the runway, I think it's quite obvious also from the balance sheet, that we have some SEK 48 million on the balance sheet as of end of September, and with our current cost run rate of in that region, without giving any detailed forecast, I think we have one quarter of runway, which is not acceptable, of course. And that's what we, the board and management, are working on as we speak, and we will come back when we have something to disclose. But it's important to understand that this is also a part of the strategy to exercise the warrants, but there will be other avenues that we need to explore as well, though. So we will come back on that matter when we have something to discuss. Do we have any more questions, Greta? We have no new questions in the chat. I don't know if you have received any, Søren, on your end. You are on mute, Søren. Sorry, too much technology. Yeah, no, I... There are no additional questions. I think we are at the end of today's call, and I want to thank you all for participating, listening in, and also thank you all for your questions. Thank you. Thank you. Thank you very much.