Welcome to the Cantargia Q4 2023 report presentation. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound 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. Thank you so much. It's a pleasure to be here and present Cantargia's year-end report for 2023. To start with, I think it's been a very exciting year and it's been an exciting period. We're also looking forward to some very exciting months to come. Let's get into the story then. During the period, and/or during January and February, there's been a good news flow and we presented new, very interesting data for our lead program, Nadunolimab, in combination with chemotherapy in triple-negative breast cancer. We have presented new preclinical data, which gives further support for both our clinical programs in cancer and cardiovascular disease by showing effects on vascular inflammatory responses. On a completely different topic, there has also been some movements in our patent portfolio, and we will go through that in more detail later. But in principle, as you all know, there has been some opposition processes. One of these opposition processes were concluded last summer, positively for Cantargia. The decision was first appealed by a third party, but later on withdrawn. We took also the opportunity to do a directed share issue of approximately 60 million to prolong our runway into 2025, and also to provide the means to prepare the upcoming pancreatic phase II b trial. And then during this year, we presented the first clinical results with our CAN10 antibody, which were very positive, showing good safety. But also, which I think is of major importance, is that we could already, at the initial dose levels, show that CAN10 is binding to its target IL1RAP. And it's doing that in a dose-dependent way and very, very much predicted from a clinical model. We also presented new results on Nadunolimab and its potential to alleviate chemotherapy-induced neuropathy, which has lots of relevance not only for chemotherapy combinations, but also for ADCs. We will come back to that later on as well. Finally, we got regulatory approval to start the phase II b pancreatic cancer trial PANFOUR in the US and are now moving forward to start recruiting patients mid this year. To quickly go into the pipeline then, as most of you probably know, the lead program, Nadunolimab, has been explored in a number of cancer forms. The most extensive data has been generated in pancreatic cancer, which is PDAC, triple-negative breast cancer, TNBC, or non-small cell lung cancer, NSCLC. In PDAC, we've treated more than 70 patients now in the first-line combination therapy setting. And that's really where we see a very interesting signal, which is forming the basis for the upcoming phase II b trial. In triple-negative breast cancer, the phase II trial, which is a randomized trial, is already ongoing. In the non-small cell lung cancer, we treated about 40 patients in chemotherapy combinations. And we are, as the data maturing, we're learning more and more on how to take the potential next steps here, and we'll come back to that in the presentation. The CAN10 program is being developed for myocarditis and systemic sclerosis. It's a different antibody than Nadunolimab, but it's directed against the IL1RAP as well. The lead indications are, as I said, myocarditis and systemic sclerosis, but the phase I is obviously done initially in healthy volunteers, followed by patients with psoriasis. Then we have a CANXX program, which contains lots of exciting opportunities for the future as [uncertain] products advance. Okay, so let's restart again. I'm sorry if we had a power failure here. But to continue, we have presented very interesting data in pancreatic cancer, showing that patients treated with Nadunolimab in combination with gemcitabine Abraxane in the first-line setting have overall survival and a progression-free survival, which is much longer than you would expect from chemotherapy alone. So 13.2 months survival, which is longer than the approximately nine months you would expect from gemcitabine Abraxane, and a PFS, which is about two months longer than expected from gemcitabine Abraxane. So if we take the next slide. Yeah. We can also see that if we do a subgroup analysis, patients that have high levels of the antigen IL1RAP have a better benefit than patients with lower levels of a target IL1RAP. And that's very exciting because the prognosis for these patients is worse than. So with high IL1RAP, you have worse prognosis, but you're doing better with the therapy. So this is clearly something we can build on in the upcoming clinical trial. And if we take the next slide. The trial we're starting this summer and where we just recently got approval to start in the US is designed as a 150-patient trial with an interim analysis after 60 patients. It will study two different doses of Nadunolimab, 80 mg and 200 mg, in combination with chemotherapy and then having a control group of chemotherapy alone. And during the trial, we will allow all comers to enter the trial, but we will measure if they have high or low IL1RAP. And that will then be used as a predefined subgroup analysis to take the next step. If we go to the next slide now, I can show you a little bit on what the timelines look like. The plan is to start the trial mid-2024. We expect rapid recruitment. We have had very good response from participating clinical centers. We believe that during H1 2025, we will be able to do this first snapshot analysis of the 60 patients. That can form the basis. If data looks promising, that will obviously be the basis for an FDA meeting. Also the start of phase III preparations. There are several opportunities here. One, if the data looks positive, is obviously to continue to make the study bigger and extend it. Another opportunity, which is what we have shown you plans on here, is to start a phase III trial 2026, where we can have results in 2028 and file the BLA submission during 2028. So we believe that doing this initial trial is de-risking the whole development pathway, and it's also addressing the FDA's Project Optimus and other guidelines. So we believe that we're in a very good position now to advance a program in pancreatic cancer in an efficient and risk-mitigated way. Next. So then moving over to triple-negative breast cancer. Again, we've shown positive results in the initial trial of 15 patients, which was some kind of lead-in to the phase II randomized study. But in the phase I part, we saw a response rate of 60%, which is about twice as high as you expect from chemotherapy alone in this patient population. The survival and PFS was much longer than you would expect from chemotherapy alone. The safety was very good, so we didn't really pick up any safety concerns or side effects except those that you in principle expect from this combination and from chemo. The randomized phase II is currently ongoing, and we expect to have the first results late this year. That is all well and up and running as well. Then moving into non-small cell lung cancer. As you may recall, we have seen very positive data here as well with high response rates, with good PFS and survival. But lung cancer being a very competitive indication with lots of new therapy centers in the stage, we made the strategic decision to work with a biomarker approach to really identify the patients most likely to respond. What's driving this decision? That we have observed two patients with a complete response. And just to remind you, complete responders are very rare in non-small cell lung cancer. Even if they get immune therapies, it's typically less than 1%. So having two patients out of 30 is a very good signal. And we narrowed it down to see that these are patients that have non-squamous non-small cell lung cancer. Okay. So if. Speaker, please go ahead. Yep. So within neuropathy, we've seen some new data, which was presented not too long ago. And the background is that several of the chemotherapies used to treat cancer induce neuropathy, which is a very, very serious side effect, which can lead to discontinuation of otherwise very active drugs giving responses to patients. So there is a very big medical need to counteract that or alleviate the symptoms. And what we've seen with Nadunolimab in our pancreatic cancer trial is that we're getting much lower incidence of neuropathy or grade 3 neuropathy than you would expect from historical controls. It's 1% versus 17%. And what we've done then is that we've done further analysis looking into grade 1 or 2 neuropathies. And without going into details, we see a very strong signal here as well. Those data together with what we've also seen in animal models as well as with ADC payloads inducing the IL-1 system will be presented at upcoming scientific conferences. So currently, we are working to get more and more details around this, but clearly, we wanted to inform the market about these findings if possible. So then moving away from Nadunolimab into the CAN10 asset. And to repeat, CAN10 differs from Nadunolimab in that it's a very potent IL-1, IL-33, and IL-36 blocker, while Nadunolimab is primarily an IL-1 blocker equipped with an ADC feature. And the development is geared towards systemic sclerosis and myocarditis, which are two diseases with very high medical need, which involves these cytokines. So the first-in-human study is already ongoing, and we presented the first clinical data. And this is showing a little bit on the study design. So we're doing an IV administration of healthy volunteers to start with as single doses to study safety, but also to study biomarkers. We're presenting more data on that. We presented the first data on receptor occupancy. Interestingly, what we will do then is to move into psoriasis patients in multiple dosing, which is primarily a safety study, but we can do so much more by looking into biomarkers. Psoriasis is interesting, as you can see in this slide, in that several of the components we're addressing, like IL-1, IL-36, IL-33, are elevated in this type of disease. We will study this by taking both biopsies from patients as well as do something called skin tape strips, which is basically just taking some tape on the skin surface and then analyzing for biomarkers. And thereby, we are planning to start to identify mechanistic differences as we continue to treat with CAN10. And the MAD part is planned to start during Q3 this year once we have reached enough high doses in the SAD part. And then the preparations for the phase II clinical study are ongoing, and we will disclose much more around that once we have advanced and have had various advisory boards around this. But the status is that we have shown that it's safe in GLP-tox studies. We have several preclinical models showing efficacy. Phase I is ongoing. As I said, it's done in Germany, and we have had good safety so far. We've done receptor occupation studies, which are very positive. And in total, we will treat up to 80 individuals in this trial. So then coming back to IP, because there have been lots of discussions around Cantargia's IP. And what I would like to point out to this slide is that we have very strong IP. First of all, we have a composition of matter patents on both lead antibody CAN04, which expires 2035, or CAN10, which expires 2041. And all these expire dates are excluding any potential prolongations, which may get along the way. But we have decided to communicate this in the most conservative way. We also have IP around the use of anti-IL1RAP antibodies for treatment of solid tumors, hematological diseases, and some others. And it is really the more. It's not the composition of matter patents that are in focus of the various oppositions. It's more, let's say, other details which provide a further layer of protection and provide some protection against competitors that have been opposed and appealed. So overall, we believe we have a very strong IP situation, and most of these oppositions and appeal have been sorted out and have been ruled in our favor. So by that, I would like to hand over to Patrik and to go through the financials. Thank you, Göran. I'm just going to show you a couple of slides of the financial highlights. Gorann has already mentioned a lot of things that have happened at Cantargia during the fourth quarter of 2023, but also during the full year. We've done a lot of things in R&D, less costs than we incurred in the year before, both in the quarter and in the full year. We're still doing a lot of things. We have ongoing activities for the Nadunolimab projects, such as the TRIFOUR study. We are winding down the phase I/phase I b studies, CANFOUR, KAPPAFOUR, CESTAFOUR, SERAFOUR. That's also why you are seeing that we are reducing our costs. We are offsetting that, and we have offset that by increased investments in the CAN10 projects, the phase I study that Gorann alluded to, and also the preparations that we have done for the upcoming PANFOUR study. But all in all, the R&D expenses in the Q4 amounted to SEK 68 million, a reduction of SEK 20 million or 21% versus Q4 of 2022. And if we look at the other expenses in the quarter, they were slightly higher. But all in all, we ended at SEK 71 million, SEK 19 million or 21% lower than 2022. If you look at the full year, our R&D expenses were 273, again, lower than the prior year by approximately 25%. Again, the same reason that I explained for the Q4, mainly the wind down of the Nadunolimab early clinical program and less CMC production costs in the year than in the previous years. We are happy that we have been able to keep our G&A costs, so our general and administration costs, flat, although we have experienced quite significant inflation pressure. So we've been able to mitigate that by savings and cost reductions to make sure that we're not allowing that to slip away. So the net loss, so the total operating expenses amounted to SEK 290 million. And we were able to offset that through gains from interest rates and short-term investments of approximately SEK 10 million to report a net loss for the full year of SEK 280 million. In terms of our cash situation, you know that we report total available funds as a net of or a total of reported cash and cash equivalents and the short-term investments. Those amounted to SEK 195 million in the end of the year. That included the proceeds from the share issue of approximately SEK 55 million net. With our existing plans, we expect that the current available funds will last into 2025. With that, I'd like to hand over to Goran for the closing. So thank you. So I hope we've shown that it's been a good period for Cantargia, that we have lots of things in the pipeline. And by showing this slide on upcoming milestones, I hope you share my enthusiasm for 2024 and what we have in front of us. So in the pancreatic cancer trial with the start of the phase II b trial mid this year with the phase II b topline data in 2025, including both, let's say, perhaps on all 150 patients as well as early results on 60 patients. We have much more to provide in non-small cell lung cancer once we have long-term effects in all patients and biomarker data. And in triple negative breast cancer, we expect the ongoing randomized trials to be fully recruited and to have randomized phase II data later on this year. CAN10, we will continuously update the market when we have relevant news in the dose escalation, and especially once we start to generate biomarker data. Finally, we have a number of clinical trials which were basically stopped last year. Several patients have continued therapy as they've done well. We are hopefully soon ready to present the results from those trials. Also, we have a number of preclinical translational studies ongoing. Once we have results from those, that will be presented. So by this, I'd like to thank you for your attention. I'm very happy to take questions. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Richard Ramanius from Redeye. Please go ahead. Good evening. I have a few questions. Let's start with the financial ones. You reported liquidity of almost SEK 200 million, and you stated that will fund this year's activities. So that would imply a burn rate of around SEK 50 million per quarter. That seems slow compared to your expenditure last year. Do you have any comments? Yeah, I can take that question. So during 2023, we still had several expenses in the TRIFOUR, CANFOUR, and the PANFOUR trials. Even though the trials stopped recruiting, quite a few patients continued to get therapy and the documentation monitoring. So with those studies terminated now, we certainly have a much lower burn. Great mix. Makes sense. I'd also like to ask if you could discuss your funding options, if possible, for the pancreatic cancer trial. Yeah, I think we have a number of parallel discussions ongoing, and I don't want to go into more concrete details around that until we are through with the financing of the phase II b trial. Yeah, I understand. Considering the readouts for this trial, when did you say the interim readout would be and the full readout from the 150-200 patients? It will be 150 patients, which will be 3x 50 patients. We will do the first analysis on 3x 20 patients, which equals 60. We hope to have those data early next year if recruitment rates can keep up as promising as the feasibility studies suggest. Then we will have data on the 150 patients towards the end of 2025. Continuing on this same trial, do you have any idea about the possibility of obtaining accelerated approval? Will you power the study to demonstrate statistically significant overall survival? Yeah. No, so I think one of the options we have here is to have a discussion with the FDA based on the first 60 patients and together with the FDA start to discuss the opportunities for breakthrough designation, accelerated approval. If this means that the PANFOUR trial should be, let's say, expanded into a bigger patient population, or if we should go another way, I think it's very much data-driven, but we're not excluding anything. Okay. My last question about the breast cancer study is my assumption was that the ongoing phase II b or phase II study will be phase III enabling. Is that correct? As a follow-up to that, this makes it a late-stage asset. How would that affect partnering discussions and interest? Yes, the phase II, it's obviously a randomized trial in triple-negative breast cancer. If the results are good, obviously the next step would be a phase III trial in triple-negative breast cancer. Then exact details are pending. When it comes to, let's say, partnering interest, again, it's one of these things where we always have ongoing discussions, but I don't want to, let's say, comment on more details around that. Okay, thanks. That's all for me for now. Yeah. The next question comes from Luisa Morgado from Van Lanschot Kempen, NV. Please go ahead. Hi team. Thank you for taking my questions. I have a few, maybe starting with PDAC indeed. Could you remind us how much the PANFOUR study is projected to cost? And in terms of operating expenses for this year, can we expect a further decrease or now to maintain stable? Yeah, if you could comment on that, please. So the pancreatic PANFOUR trial, we have not disclosed the exact cost, but I think you can estimate that each patient in an oncology trial like this would cost somewhere around EUR 100,000-EUR 200,000 each, a little bit dependent on the territory they come from. So then you can probably make the calculations of how much a 250-patient trial could cost. And then for the runway, so without a pancreatic cancer trial, you should definitely expect the cost level to go down during 2024 compared to 2023. Once the trial is up and running, obviously, you will add this cost compared to what we've been guiding for. But currently, the cash we have on hand will take us into 2025 without the pancreatic cancer trial. Okay, very clear. Maybe could you elaborate a bit more in terms of PDAC? What is the FDA exactly looking at? In your view, what are the most important endpoints? Does the FDA indeed only look at median overall survival, or is PFS also, yeah, quite important? I think the short answer is that the FDA would value a survival advantage very high. And then I guess if you have very convincing differences in PFS, that's definitely an opportunity to have a discussion with the FDA. Okay, very clear. And maybe just the last question on the triple-negative breast cancer trial. What is the benchmark here that you're trying to surpass with the data that you're presenting at the end of this year? So the triple-negative breast cancer trial, it is primarily a hypothesis-generating trial to understand if triple-negative breast cancer is a good indication. So the trial is not, let's say, fully powered for statistical significance. But we're clearly looking for strong signals of activities, and the opportunity to perhaps also do some subgroup analysis. Okay, thank you very much. That's all. The next question comes from Arvid Necander from Carnegie. Please go ahead. Good afternoon, and thanks for taking my questions. First, on the PANFOUR studies, with the interim analysis being baked in and the sort of adaptive study design, do you see an opportunity for sequential financing where you wouldn't need to raise the amount for the whole study upfront? So yes, in principle, as long as we can finance our commitments, it's possible to do it in tranches. Okay, thanks. And then secondly, on triple-negative breast cancer and the readout towards the end of the year, how should we think about positioning here, and what are the most relevant comparisons? I guess with Trop-2 targeted ADC combinations being investigated both in the frontline and the setting of the advanced setting and the neo-adjuvant setting, how do you expect Nadunolimab to sort of fit into the paradigm here, and what are the most relevant comparisons? Yeah, so triple-negative breast cancer, just like non-small cell lung cancer, it is a landscape which is currently changing a lot. And I think there are various opportunities on how to advance Nadunolimab in triple-negative breast cancer. So one is, if you make it simple, saying that if we have combination data with gem carbo, suggesting that this is, let's say, an active combination which is better than gem carbo alone, clearly you need to figure out if this can be done in first line, second line, or if it's more a third line opportunity in the future. The second, which I think is, let's say, a very exciting opportunity, is that we're starting to develop data suggesting that Nadunolimab in combination with ADCs could be a very attractive way forward. So clearly, top two combinations or whatever would come up in triple-negative breast cancer could also be a way forward. So we're trying to figure out what is the best way, and we will have more advisory boards around this during the year and probably be in a better position to exactly communicate what is the best way forward in triple-negative breast cancer once we have those. And there is also more data to be generated with the Trop-2s. So more to come, but I see several opportunities both as a gem carbo combination as well as an ADC combination. Okay, thanks. And I guess just assuming that you go ahead, at least in the first step with the gem carb combination, is it fair to assume that the at least immediate opportunity is likely to be the second- or third-line setting of advanced triple-negative breast cancers? That's a fair assumption. It's a reasonable assumption. Okay, great. Thanks so much, guys. Thank you. As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad. The next question comes from Richard Romanius from Redeye. Please go ahead. I had another question about CAN10. Could you just remind us about how you're studying the IV versus the subcutaneous version, and which you intend to go forward with? So the subcutaneous is most likely the commercial opportunity we're looking for, especially if you go into chronic diseases like systemic sclerosis. For, let's say, very acute indications like myocarditis, there could be an opportunity for IV. But most of the diseases that could come in play, both systemic sclerosis as well as other dermatological or, let's say, more autoimmune chronic diseases, would be a subcutaneous formulation. Yeah, sounds reasonable and similar to the commercial versions. But how are you implementing these in your current phase I study? Based on the toxicity studies, we're seeing, let's say, a very good translation between IV and subcutaneous. In the single dosing, we're using IV infusions, and in the multiple dosing, we will use subcutaneous. Okay, perfect. Thanks. The next question comes from Sten Westerberg from Analysguiden Please go ahead. Thank you, operator. Good afternoon, everybody. Just a clarification on the dosing. You show a flat dosing in your schedule for the PANFOUR study. Just to understand, is this equivalent to the dosing which is used in the TRIFOUR study, 1 mg per kilo and 2.5 mg per kilo? That is my first question. The second one is if the top line data that you expect to release from TRIFOUR by the end of this year will be based on the fully recruited population. Thank you. Thank you, Sten. So the first one, the flat dose versus the previous dosing per kilogram is basically based, so they should be equivalent. So assuming that 1 mg per kg for an 80 kg patient would be 80 mg. So that's the logic behind then. 2.5 would then correspond to the 200 mg that we're using in the trial. We've also done lots of PK analysis to show that this is a sensible way forward. The second one, the TRIFOUR data. So the goal is definitely to present data on all patients, but clearly it will be short-term data for patients that are recruited later during the year. So it will certainly, you can call it top line, you can call it some kind of interim data, but it will be the first dataset. Okay, that concludes my question. Thank you. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments. So thank you all for the attention. So I'm very positive about, let's say, how Cantargia can continue to evolve during 2024. And I look forward to giving you the update during the next Q1 conference call, and I'm sure we'll have some exciting news in between. So thanks a lot.