Welcome to the Cantargia Q3 2023 Report Presentation. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now, I will hand the conference over to the speakers, CEO Göran Forsberg, and CFO, Patrik Renblad. Please go ahead. Thanks a lot. It's been a very good period for Cantargia, and it's really a pleasure to present the progress we made in our projects at this Q3 report, as well as the financial updates. So by going directly into the story and what has happened, so obviously, we presented new data in pancreatic cancer, which is the lead indication for nadunolimab. And we've seen... And we're coming back to that, but we've seen strong efficacy in general, but we also seen very strong effects in patients that have the highest levels of the target for our therapy, IL-1RAP. And we've done further into this to see that, for instance, IL-1RAP is linked to KRAS mutations, which are associated with aggressive disease. So it gives us more and more confidence that the drug is really what's doing what it's supposed to do, and that it can be a meaningful drug in the future to treat pancreatic cancer patients, and especially those with the worst prognosis. We also seen in other studies, in collaborations with the world-leading group in Switzerland, looking into immune therapy in general, and that we can use nadunolimab to improve immune therapy and, for instance, to tumor vaccines. We were awarded a grant from the U.S. Department of Defense, and this is a very, very important, let's say, both milestone as well as recognition of what we're doing. And this grant was awarded to do a Phase Ib/IIa trial in leukemia, which we really look forward to do together with our collaborators at MD Anderson. We had progress in the second program, CAN10, and we started a Phase I trial and are now treating patients according to plan, and hopefully, more to come in future around that. But the Phase I trial started, and we now have two clinical programs. We also got an orphan drug designation for CAN10 for systemic sclerosis in the U.S., which is obviously strengthening the whole case around the story here. There's also been interesting moments around one of our patents. It's not one of the core patents, but as you may know, Cantargia has several patents, which are not only related to our drugs, but also to IL-1RAP as a target. And several of those has been opposed lately and, but so far, everything has been very successful for Cantargia. And during the summer, we had another opposition process at European Patent Office. It was basically decided that the patent would be more or less up. There were some updates in the patent scope, but in principle, the patent was deemed to be still valid. And we just were informed that this decision has been appealed by a third party, and it clearly shows that there is a commercial interest in the biology that we're investigating. We also done presented new data recently in nadunolimab in combination therapy in triple-negative breast cancer, which was presented at ESMO. We'll present more on that. And just recently, we did a directed share issue to raise approximately SEK 59 million, which prolongs our runway into 2025. So a very eventful period and October, and hopefully more to come. But by that, this, I will hand over to Patrik to start with the finances, and then we'll do a deep dive into the projects. Thank you very much, Göran. Let me then first start with some key messages related to our P&L. On the left-hand side here, on this slide, you can see the development of our operating expenses. In the quarter, we reported OPEX of 79 million SEK, 6% higher than the same period, 2022. The trend of lower cost from our clinical studies for nadunolimab continued, but they were offset by increased investments implied by the initiation of the CAN10 clinical study, as well as production of investigational medicinal products for both our projects in the quarter. As you can see, Cantargia continues to invest the lion's share of our investment into R&D, 96%, and we operate with a very lean G&A. We recognize currency gains on our hedging, which provides a positive net financial items of SEK 2 million in the period, reducing our reported loss to SEK 76 million. Right hand of the slide shows the year-to-date developments, and there we have decreased OpEx in the first nine months compared to 2022, to SEK 219 million, down by 25%, mainly as a result of the focus that we have now been working on for a while, focusing the clinical program to fewer randomized trials. Net financial items in the quarter were SEK 8 million, and that reduced our operating loss to SEK 209 million for the period. Our available funds, which consists both from the IFRS part, which is cash in the bank, but also the short-term investments that we have, is developed as according to this graph here. It decreased by SEK 87 million in the quarter to SEK 200 million, and that, I should say, is excluding the recently conducted share issue of SEK 59 million, as that occurred in the Q4. With our existing plans, we expect that the available fund and the proceeds that we now have in our banks from the share issue will enable a runway into 2025. Yeah, so the directed share issue was announced on October thirtieth, just a few days or a week ago. And it means that we issued, with a mandate from our annual general meeting, 10% of our shares, or say 16.7 million shares, at a price of 3.55 SEK, which was then the weighted volume weighted average price of the day, without any discount, and that implied total proceeds of approximately SEK 59 million, and that represents a dilution of 9.1% after the share issue. We have very strong support from our existing shareholders, and they contributed into this issue, notably the Fourth Swedish National AP Fund, the AP1, and also Alecta Tjänstepension, together with other institutional and private shareholders. We will use the proceeds from this issue to continue our preparations for the Phase IIB trial with nadunolimab, that Göran will talk about more later, as well as general purposes, which extends the cash runway into 2025. As I already mentioned, the transaction has been closed, and we have received the proceeds into our accounts. With that, I conclude my short financial update and hand over to Göran. Thank you, Patrik. So, to remind you all about our pipeline, our lead program nadunolimab, it is being investigated in pancreatic cancer, triple-negative breast cancer, and in lung cancer. In pancreatic cancer, we have Phase II data and are now planning a Phase II B trial in the first-line setting. In triple-negative breast cancer, we are currently doing a combination trial, which is randomized, combining nadunolimab with chemotherapy versus chemotherapy alone in first- or second-line setting. And in lung cancer, we completed recruitment earlier this year and are now evaluating the data before deciding on what potential next step might be. More to come around that next year. What's also very exciting is that our second program, CANxx, which is being developed in autoimmune inflammatory diseases, is recruiting healthy volunteers right now in the Phase I setting, and the idea is to take this compound into Phase II in myocarditis systemic sclerosis once that's ready. We also have a CAN-XX platform program, which is much earlier to look into new opportunities within the IL1RAP space. So moving over to pancreatic cancer and, very briefly, we treated 73 patients in the first line setting with combination with gemcitabine Abraxane, which is standard, one of the standard therapies. And what we consistently see is much better outcome than you would expect from historical controls. So response rates are better, and as you can see in the waterfall to the right, the tumor reductions are much more pronounced and are much more long-lasting than you would expect from chemotherapy alone. It all translates into a very promising overall survival, which is above 13 months, and that's much better than what has been reported with gemcitabine nab-paclitaxel alone, which is more in the 9 months region. So a 4 months difference here, obviously, versus historical control is still very, very encouraging and something that needs to be taken forward. What's new then is that we've seen that patients that have the highest levels of the target for our therapy, which is IL1RAP, are doing better. So we can actually, if we divide these patients according to IL1RAP levels, we can see that we have a 14.2 versus 10.6 months survival. And to the right, you can see that again, the deep responses are found in the IL1RAP high group. So it clearly points us that the patients that should be the target for our therapy are also those that are responding the best. So one further evidence that we're on the right track. Another evidence comes to patients that have received nadunolimab as monotherapy in pancreatic cancer, and we have biopsies from 17 patients. And again, what we see here is that the patients with the high IL1RAP levels are those that are doing much better. So now we're in the third line setting, so we have a much worse prognosis, but we can see progression-free survival, which is approximately twice as long as those for those with high versus low, and the survival is also more than twice as long for patients with high IL1RAP. So a strong evidence that nadunolimab is doing the work, especially in patients with high IL1RAP. We are just to say that we're now taking this forward into a Phase IIB trial, which we will obviously re-present much more about once it's starting. Currently, we are... Let's say, once we have the protocol approved, we can present more on the design. So in triple-negative breast cancer, we present the new data at ESMO in October. Again, what we see here is that in a different disease, that when we add nadunolimab to the standard therapy, chemotherapy, in this case, we again get much better results than you would expect from chemotherapy alone, and this relates to response levels, also to the tumor reductions, which you can see to the left here, and the survival and progression-free survival. Everything is longer than you would expect from chemotherapy alone. This trial has already expanded into the Phase II part, where we are looking at the combination therapy in one group and then the chemotherapy in the second group, and much more to come around that during 2024. And then in the further indication, lung cancer, it, it's a similar story. Here, we've done combinations with chemotherapy in patients that are either first line or second line after immune therapy, and we consistently see a very, very potent effect here, including two patients with complete response. And just to point out that complete responses are very rare in lung cancer, even if they get immune therapy. So, if you look at this slide here, up to the left, you can see the nature of these two complete responders. So one that was both have received immune therapy before and are no longer responding to that. But up to the left, you can see that the tumors disappear with treatment. It takes different time periods, but to the right, you can also see the CT scan. So you can see that the patient had a lot of tumors before, and everything vanished with treatment. So something which is very exciting, but we are also trying to understand more what is really common between these patients so we can find the segment where we have a best chance of success, and that would be a very good starting point for to take the program further in lung cancer. So the key messages around nadunolimab is that we treated almost 300 patients now. We see clear signals of efficacy, both as monotherapy as well as combination therapy. And we in three different cancers, which are all have that in common, but we have a immune suppressive tumor microenvironment, be that or pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer. We all see that as very promising opportunities for further development. In pancreatic cancer, we also see that the target patients with the highest target levels respond best. It's obviously a very challenging disease, and if we can define patients with the best chance of success, it is going to make development both faster and, let's say, more likely to work out. So it is really de-risking the whole development program. We have controlled trial ongoing in triple-negative breast cancer, and we're preparing it in pancreatic cancer, which starts early next year. So moving then over to CAN10. CAN10 differs from nadunolimab in that it's binding IL1RAP, but it's blocking not only IL-1 signals, but also IL-33 and IL-36. That opens up lots of opportunities in the autoimmune inflammatory space. We've seen effects in various mouse models of lots of diseases like myocarditis, systemic sclerosis. That's our lead indications, but also in psoriasis and other inflammatory diseases. Just a few words about myocarditis and the systemic sclerosis. It is two diseases that are very, very severe. They can be lethal. They are not so common, but for instance, myocarditis is one of the leading causes for deaths in young people. And they are probably both orphan, and we have received a orphan drug designation in systemic sclerosis, and we are very enthusiastic to move the program forward in this indication. What I like to point out, though, is that we have seen effects in psoriasis or in different forms of psoriasis and in models of psoriasis. You can see here that, for instance, up to the left, that the effects in the orange line here, it's pretty clear that we have an effect on disease development. But if you only block IL-1 beta, you don't see the same effect. So it is really an effect of blocking all these systems at the same time, and that is really a unique opportunity we have. But we are not planning to do psoriasis, but we are still in the Phase I, we will actually include healthy volunteers with mild to moderate psoriasis. So it gives us a very early opportunity to get some kind of a proof of mechanistic concept here by taking skin biopsies from these patients and see if that can be correlated to what we've seen in these disease models. So we're extremely enthusiastic about this opportunity. And if you look at the product status, so we've done everything that was needed to start this study. We have a very good safety profile in the GLP tox study, we see strong effects in models, as I said, and the Phase I is ongoing, and in Germany. And we will present data during 2024, probably in different portions. So to summarize, everything before we get into the questions, I expect that we should have a very good news flow in the future. So not only that we had a good news flow in 2023, it will continue. So in pancreatic cancer, obviously, the start of the trial, and then Phase IIB top line data in 2025 is what's on the plate. But there is also going to be much more information from the ongoing trials as we learn more. Lung cancer, there is lots of data to be presented to really explain why the patients are benefiting from long-term efficacy and long-term biomarker studies. So perhaps later this year, but especially in 2024. And the triple-negative breast cancer data, obviously, that I know everyone is very excited to see once we have the top line data later in 2024. And the CAN10, there will be results being presented continuously as we have something robust and meaningful to present during 2024. And then there are other trials which were stopped earlier during development, and we will be in a position to start to present a little bit around that. So, by that, I would like to thank everyone for your attention and very, very happy to take questions. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Richard Ramanius from Redeye. Please go ahead. Good afternoon. I had some questions about costs and some about your studies. I'll start with the cost questions. Two questions which are related, and the first one is, what proportion of the startup costs do you or in relation to total costs you have in your clinical studies? That is, how much do you pay at the start and how much during the costs and related to this, expected costs will have to decrease, operating costs will have to decrease in the coming quarters if your cash position is to last into 2025. Yeah, Patrik, I guess it's Patrik who's answering. So I start with the last one. Yes, you're absolutely right, Richard, and thank you for the questions. We expect our operating expenses and our net cash outflow to decrease. ... quite significantly from 2024 and ongoing, and thereafter, assuming that we don't start the PANFOUR trial, which we don't have in our current plans, but of course, we expect to do with, and then the plans will change. So yes, we definitely expect that we won't have, for example, production of GMP batches for both our programs that we had in the Q3. We pay. So the first question, how much do we pay up front? And it varies from study to study. Yeah, I— It's somewhere between 10, 10... Yeah, I think it would be wrong to give a general answer there, Richard. Okay, I understand. It's just you, you have substantial upfront costs. I think that, is that correct to say? Yeah, we have... I wouldn't say we have substantial upfront costs, but when we start a study, we need to pay prepayments to the CROs in order for them to have funds for their expenses. And And that's the case for all our studies. And you see that also, if you look at our balance sheets- Yep. under prepaid expenses. So what we have now in the closing down session or the closing down phase of our studies is that that is then reconciled toward the closing costs. Makes sense. My second question is not really from the cost perspective, but perhaps you could might comment on the cost as well. That's what trials are still active and have patients on treatment? And I intend starting from CANFOUR and forward, let's say, except for the SLOS2, TRIFOUR, and CAN10, which obviously are recruiting. Yeah. So, yeah, as you said, it's only right now, it's only TRIFOUR and CAN10 Phase I trial that are recruiting. All the other studies have completed the recruitment. We don't have any patients under active treatment in CIRIFOUR, CESTAFOUR, CAPAFOUR. We still have patients under treatment in CANFOUR. The patients that used to be on treatment being transferred over to compassionate use programs. Okay, and then, my last question, I guess, to Göran, could you say any more about the next triggers for CIRIFOUR and CESTAFOUR, or when will we get more information from those studies? So, for SIRI4, which is the Keytruda combination, we presented data at ASCO 1.5 years ago. We now, let's say, closing and wrapping up a study, and once we have a, let's say, the database locked, we will communicate the results on that. I hope it's not going to be too far away. And it's the same for the SESTA4, which is, let's say, the trial where we investigate the different combinations and the different diseases. You should, we want to be transparent, but we also need to do all of formalities correct and have a locked database and then communicate based on that database. It's, as you know, it's relatively small trials. We didn't take them all the way through, and to not be misleading, we want to make sure that you get the correct and final results directly. Okay, thank you. Thank you very much. That's all for me. The next question comes from Sebastiaan Van Der Schoot from Van Lanschot Kempen. Please go ahead. Hi, team. Thank you for taking my questions. The first one is on the CAN10 study. I'm wondering whether you will be able to enroll the psoriasis patients already within 2024? And what will drive the inclusion of patients with sclerosis or myocarditis? And then I have a follow-up question. So, the CAN10 study, it's designed as both single dosing and multiple dosing, and the multiple dosing will only include patients with psoriasis or these patients, while the SAD part will only include healthy volunteers. And once we documented the safety at a certain dose level with SAD, the MAD part will start, and that will definitely start here in 2024. Okay, and what will drive the inclusion of patients with sclerosis or myocarditis? Do we first need to see data on psoriasis patients or? So that will be- How do you- No, you're right. So, this first CAN10 trial is not planned to include patients with myocarditis or systemic sclerosis. Instead, that will probably be done in 2025 when we have data from—we need to have a full safety documentation before we can enter into these trials, but we'll definitely do it as quickly as possible. It may also be that we will start one indication ahead of the other, so you should probably not expect them to start in parallel. Okay, got it. Then, regarding the PDAC study, the new Phase II randomized, can you maybe expand a little bit on the anticipated recruitment rate? How many sites will be enrolling patients, and how does that compare to the CAN04 study? So the feasibility is still ongoing, so I cannot comment on number of sites, but it's going to obviously be much bigger than the CAN04 trial. So far we have seen a very high interest from centers to participate with, let's say, very good recruitment numbers anticipated. I think we need to... Well, I will not be in a good position to communicate about all this until we've had the regulatory approval of the protocol. Okay, got it. Thank you. The next question comes from Sten Westerberg from Analysguiden. Please go ahead. Well, good afternoon, everybody. I wonder if you could expand a little bit on why you decided to move away from an interim analysis in the TRIFOUR study. Is there any specific reason for this decision? Yes. No, I think the main reason is that when we designed this trial, we had, we didn't know what efficacy would look like. So we built in 2, let's say, some kind of safety guards here, that we will not continue to treat patients if we didn't see the signals. We think that the Phase I data are so strong that a futility analysis very early into the Phase II part won't tell anything to us. It's rather risking to be a little bit misleading because it's relatively few patients, and it's also, let's say, they will only be treated for a very short period of time. So, we didn't see a reason to do a futility analysis, and we didn't really see that this comparing 2 times 14 patients treated for a very short period of time would, let's say, generate anything that was robust enough to communicate. Okay, fair enough. Last question then. Is it still your timeline to have a fully recruited study by the end of this year or by the end of mid-next year? So, you mean the triple-negative breast cancer trial? Yes. Yes, the TRIFOUR. Yeah, no, so our timeline or plan is to generate top-line data late 2024, and obviously the trial should be fully recruited before that. Okay, fair enough. Thank you very much. That concludes my questions. The next question comes from Sebastiaan Van Der Schoot from Van Lanschot Kempen. Please go ahead. Hi, guys. I just wanted to follow up on the, on the question with the TRIFOUR and the futility analysis. You just mentioned that it didn't really make sense to disclose the data. I'm just wondering what the futility was based on. Is it based... Was it solely based on safety, or were there also a necessary efficacy signal compared to the control arm necessary? So the futility, there is an expectation that in a mix of first- and second-line patients, you should have a 30% response rate in triple-negative breast cancer. So the futility analysis was based on that you have to be better than 30% response rate. But as you can see in the Phase I, in 15, we have a 60% response rate. Okay, got it. So based on that, we realized that the response rate is not really giving any additional information here. We know that we have something which seems to be active, and we need to continue. Okay, clear. Thank you. There are no more questions at this time, so I hand the conference back to the speakers for any written questions from the web or any closing comments. There are a couple of questions coming in from the web, and the first one is: Will you have a similar collaboration in the upcoming PANFOUR trials as you have for the TRIFOUR trial? And to what extent does GEICAM contribute to the capital expenses in the TRIFOUR study? Yeah, so the TRIFOUR study, it's so we're working together with the Spanish breast cancer group called GEICAM. GEICAM is obviously an organization which has an interest to advance new treatments in breast cancer, and are by that very a very active and good partner. In the PANFOUR trial, we're doing pancreatic cancer. But that trial is only so the TRIFOUR trial is only done in Spain, as we're working together with Spanish group. The PANFOUR trial will be a global trial, both Europe and United States, and there is really no organization participating in a trial designed like that. So that would be a much more traditional study design. And then GEICAM contribute to capital expenses. I would say, if you do a traditional study and you work with the CRO company, they are obviously a commercial organization. GEICAM is not the same type of commercial organization, so thereby, the per patient cost will be, is much lower in the TRIFOUR trial than in a traditional global trial. But GEICAM is not really subsidizing the trial, but they are a much more cost-effective partner. That was, as far as I can see, the only question on the web. So, by that, I would like to finish off by thanking everyone for your attention, and I'm very much looking forward to the next couple of months and presenting, if not before, the Q4 report in a few months' time, but you should expect more to happen before that. Thank you very much.