Hello, and welcome to Cantargia full year report for 2021. For the first part of this call, all participants will be in listening only mode, and afterwards there will be a question and answer session. Today, I am pleased to present CEO Göran Forsberg and CFO Bengt Jöndell. Speakers, please go ahead. Thank you so much. It's a pleasure to present the new full year report for Cantargia. If we go through the slides here and go down to slide number four, I can conclude that Cantargia evolved quite a lot during 2021 with several important milestones that were reached. During the fourth quarter we presented a very strong period with a very significant amount of news. As you can see here, it relates to new clinical data. It relates to regulatory status in Europe for pancreatic cancer. It relates to clinical trials starting with first patients in. What's also clear is that we made a very important step forward in our development in pancreatic cancer by signing an agreement with the U.S. organization PanCAN and participation in their Precision Promise phase III trial. We also had some news on the patent side, which we will spend a little bit time on because I think it's important and we like to highlight exactly what all these decisions are about. We also made progress in the CAN10 project. There is much more to come in CAN10 with preclinical data in xenograft models being presented later on this quarter. And also we updated timelines and gave new toxicology results for CAN10. if we move forward then to slide number six, which is our pipeline. most of you who know our company knows this pipeline quite well, but just to make sure that we're all on the same page here. our lead compound is nadunolimab or CAN04. and very much of the clinical development is focused on combination therapies, and we're trying to get into patients as early as possible even though there are some exceptions. the most of the indications are pancreatic cancer, non-small cell lung cancer, where we have presented promising but obviously early data where we are right now in development. still very interesting and data that are really supporting taking the compound forward in the development value chain. We're also doing lots of development in what we call a second wave, which is in to broaden program in pancreatic cancer, non-small cell lung cancer using new chemotherapy combinations or in moving ahead into other cancer forms as well. I will explain a little bit more about where we are here in our various clinical trials as we go on. The CAN10 project where we had some news flow is an antibody entering clinical trials early 2023. It's currently in the late stage documentation phase and with one important tox study remaining. The plan is to develop this compound for myositis and systemic sclerosis. We have a platform of opportunity which is based on IL1RAP being our molecular target. There is probably much more to come around this platform during this year. If we go to the next slide, which is slide number seven, to comment on what we're doing with PanCAN. PanCAN or Pancreatic Cancer Action Network is an organization in the U.S., which have a goal to develop new drugs for treatment of pancreatic cancer. They started a trial about a year ago or two years ago called Precision Promise, which was designed together with the U.S. FDA. The plan is to find four different compounds which promising activity, which then PanCAN together with companies will fund and put into a potential pivotal trial. Currently there are 15 centers, leading U.S. clinical centers on board, and there is more centers to plan to get into the trial. We in our arm of patients will receive nadunolimab together with gemcitabine or nab-paclitaxel or they will obviously be in control on of the chemotherapy alone. This is an adaptive trial design and patient design. The first phase II part will include about 100 patients. Then if the results are promising enough, it will be expanded into a phase III part and altogether 175 patients are planned in our active arm. Since it's a phase II/III trial with an interim analysis, it takes a little bit longer, but we expect to get the results in 2027 or earlier, depending on how recruitment is going. The next step right now is to do a pre-IND meeting with the U.S. FDA and the plan is to get that going during the second quarter. When it comes to funding, we are obviously funding our own, but PanCAN is also funding the control arm and some other activities. It's a good opportunity for Cantargia to participate, and it's really a sign of confidence from PanCAN that they have approached us to get us included. We obviously regard that as a signal that the data is regarded as very promising. If we go to the next slide, which is slide eight. The data we presented so far has shown a very promising progression-free survival of 7.2 months. It's followed by a strong survival time of 12.7 months, and it's the progression-free survival is much longer than you would expect from chemotherapy alone, where patients will be in the order of 5.5 months, those would be somewhere around 10 months. Obviously, significant improvement, obviously also early data. These data are based on the first 33 patients that were treated in the trial. We now have treated 73 patients, and the data are maturing, and we expect to present the full data set during Q2 later this year. We've also seen some exciting data with patients with something looking like pseudoprogression, which is then correlated to good survival and benefits for the patients. If we go to then slide number nine, we are a little bit behind when it comes to lung cancer. That cancer has enrolled very quickly. Lung cancer a little bit slower. The first data set that we have presented or let's say latest data set was from September, where we could see that we treating patients with nadunolimab plus gemcitabine cisplatin gave response rate which was about twice as high as you would expect from chemotherapy alone in these patient populations. In the order of 50% compared to somewhere around 25% expected. The signal was most pronounced in non-squamous non-small cell lung cancer, which is the biggest form of non-small cell lung cancer. Therefore, based on the fact that we need to start treating patients a little bit differently dependent on which subgroup they consist of, we're now focusing on non-squamous non-small cell lung cancer, but we're not at all excluding squamous non-small cell lung cancer at a later stage. Again, progression-free survival being about one CT scan longer than expected from historical controls, say in the order of seven months versus five months. Again, suggesting durable effects. If we go to the next slide then, which is slide 10, and which is more showing where we are in the clinical development. In the first trial, which is with the first-line opportunity, the CANFOUR trial, all the results that I showed is from this trial, and we are planning to present the updated results both in pancreatic cancer and non-small cell lung cancer during Q2 this year. There's also recruitment ongoing in a new arm focusing on non-squamous non-small cell lung cancer in combination with carboplatin gemcitabine. If we go to the next slide, which is the CIRIFOUR trial. Here we are combining with the immune checkpoint inhibitors, or pembrolizumab to be specific. This is a smaller trial than the CANFOUR trial. It's primarily designed for safety but also early efficacy. We have communicated safety of the combination with pembrolizumab, which looks very, very good with very few grade three events. Definitely a safe combination. At that point in time, the efficacy was not yet mature enough to be communicated. We know that five out of the 15 patients included in the trial were still on therapy at that point in time, with four of them having been treated for six months or longer. We are about to get new first patients in into the second phase of that trial, which is combination with both chemotherapy and pembrolizumab in patients. Given the strong results we have with the chemotherapy combinations, it's very exciting arm for us to look into. If we go to slide 12, which is basically remaining trials, and more focusing on what's in the second wave. We have activities in pancreatic cancer with FOLFIRINOX, in non-small cell lung cancer with docetaxel, in biliary tract cancer, which is the platinum gemcitabine, colorectal cancer with FOLFOX, and in triple-negative breast cancer together with carboplatin gemcitabine. All these trials are approximately at the same stage. They started during H2 last year, except for TRIFOUR, where first patient in was early this year. We are all in the dose escalation phase right now, and recruitment is going well. We are in a phase where, let's say later on this year, we will start getting robust safety data. We will start to get some early signals of efficacy, and we will then be in a good position to start prioritize all these opportunities against each other. More to come about that during later on this year. Finally, our sixth trial is Precision Promise, which is what I described earlier with PanCAN collaboration, and we are working towards a pre-IND submission for Q2. If we move into slide 14, which is related to our IP. As I said in the beginning, there has been two recent oppositions against some of our patents, and we get lots of questions around what does this really mean for us. This is a way to illustrate our IP portfolio, where you can see that we have four different families of IP covering nadunolimab. There is one in which we call leukemia, one called hematological disorders, which is related to IL1RAP as a target for treating these diseases. There's one called solid tumors, valid until 2032, which is, let's say more in line with current development plans, and protects the antibody therapy, against IL1RAP in solid tumors. Then we have obviously the composition of matter patent, which is called CAN04 which is valid until at least 2035, unless we get extended market exclusivity. But what you can see here is some dark blue dots, and that represents all the parent patents that are basically already approved and, not subject to any oppositions. In light blue, you can see various granted patents based on divisions or continuation applications. Here you can see two of them, one, both in Europe, one in the solid tumor patent family, and one in CAN04 patent family, which are obviously daughter patents, where there has been oppositions. If you look at this in a broader context, these oppositions are related to very small pieces of the total portfolio. We regard this as more proof of commercial interest to compete with us rather than something which is any type of threat to our IP portfolio as a whole. If we move further down into slide 15 and 16, where we go over to finance, I will ask Bengt to present the finance. Okay. Thank you, Göran. I'll start with the financial overview on page 16. Cantargia's operating expenses increased by 113% compared to last year to in total SEK 370.3 million. As you can see in the graph at the left was this increase related to the increased investment in R&D. In 2021, R&D accounted for 95% of the operating expenses. The increased R&D investments was mainly related to Cantargia's main project, nadunolimab or CAN04, and especially the broadening of the clinical program with the studies CIRIFOUR, CAPAFOUR, CESTAFOUR and TRIFOUR. We can also see that the preclinical studies in CAN10 increased. The number of employees increased to 26 compared to 18 last year, and this increase was also related to R&D. Page 17, please. Financial position. Cantargia has continued a strong financial position. Total available funds as of December 31 amounted to in total SEK 559.4 million. With present plans, these funds will last approximately until first half year 2023. Still with the flexibility to stretch out the runway significantly if needed. This concludes the financial overview. Back to Göran. Thank you, Bengt. I would like to sum up with the slide number 19. As you can see, it's been a very good period for Cantargia, and there is also lots of things in the pipeline, and we are convinced that we will have some very exciting news flow in the next quarters to come as well. During Q2, we will present new data in pancreatic cancer, non-small cell lung cancer and with the Keytruda pembrolizumab combination, so the CIRIFOUR trial. Obviously the next value, let's say, step in the value chain here is to start with phase II/III Precision Promise trial together with PanCAN. Obviously we would like to be transparent and so you can follow the preparations before the first patient in. We also have ongoing research when it comes to preclinical and translational results, and once they feel robust and interesting enough, we will certainly present them. Finally, when it comes to the lead project, the CIRIFOUR, CAPAFOUR, CESTAFOUR and TRIFOUR are ongoing. Once we reach or pass the initial safety phases, we will obviously let you know what's going on, what's happening here, and how our thinking comes forward. In CAN10 project, there is obviously more preclinical progress to come. We will keep you informed about the development milestones. I can see that there is a mistake here. Initiation of clinical trial should be early 2023, not Q3. Sorry for that. With this I'd like to conclude my part of the presentation, and I'm very, very happy to take questions. Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. There will be a brief pause while questions are being registered. Our first question comes from Mark Breidenbach with Oppenheimer. Please go ahead. Hey, guys. Congrats on the progress and just a couple of quick questions from me. First of all, I guess since we're expecting data later this year from the CANOPY-A study of canakinumab in the non-small cell lung cancer adjuvant setting, do you see any potential for these data to impact your development plans in lung cancer? For instance, if CANOPY-A is a success, would you consider running a trial in an adjuvant setting, perhaps in collaboration with a partner? The second question is just regard to the PanCAN Precision Promise trial. Would you expect this study population to differ much from the PDAC cohort that you enrolled in CAN04? Or are you expecting these two study populations to be more or less the same given their treatment histories? Thanks for taking the questions. Thank you, Mark. Two very relevant and good questions. When it comes to the new data from the CANOPY trials, obviously we follow that very carefully and obviously with great interest as well. Let's say the CANOPY-A trial, which is done in the adjuvant setting is very interesting because it mimics very much what the CANTOS trial, which showed very strong results using canakinumab in treatment of lung cancer. I think that they if we assume that they have positive data or if we assume that they have the other data that is supporting this indication, obviously an adjuvant trial will be of very high interest. At this point in time, we have no direct plans to start such trial. I think it's a very good opportunity, but it's a trial that takes a long time and obviously a big investment. We need to carefully consider how to do it at that point in time. Then the second question related to the pancreatic cancer cohort in the PanCAN trial versus what we have seen so far. Yes, we try to work as similar as possible, and the protocol is still under design, so I cannot go into details. The idea is to get two first-line metastatic patients, and that's really similar to what we already have. Okay. Thanks for taking the questions. Our next question comes from Arvid Necander with Carnegie. Please go ahead. Okay, thanks for taking my questions. My first question is on the European development pathway for nadunolimab in pancreatic cancer. Obviously, Precision Promise only includes U.S. centers. Are you planning for an additional registration-directed study conducted at European centers? That's my first question. Okay. What we are going to do, we will have a scientific advice meeting with the EMA in parallel with all the activities we are with the FDA in preparation for the trial. Depending on the effect from the EMA and how useful that Precision Promise trial would be for European registration will obviously guide us on our next step. It's absolutely right that the PanCAN Precision Promise trial is primarily carried out in the U.S. On the other hand, very clearly there is nothing strange about the trial that couldn't be, let's say, relevant for Europe as far as we understand. Right. How likely do you view it that EMA would accept registration based on purely U.S. data? That seems. There's not too many examples of that, I suppose. It's the main scenario that you will have to perform some sort of study in Europe. Let's see what the feedback would be. I think in oncology, typically, you would like to do trials both in Europe and United States for the simple fact that it will increase recruitment rates and just makes it much easier to perform. Obviously, I think the regulatory feedback here is important. Sure. Let us come back on that. Fair enough. Okay. I was just wondering if you can give us any indication on what to expect in terms of R&D and SG&A expenses going into 2022, at least directionally, compared to 2021. I don't know, Bengt, if you should take that question. Please repeat the question. My question was if you could give us any indication of what to expect when it comes to the development for R&D expenses and SG&A expenses going into 2022, at least on a directional level to compare to 2021. Yeah. I would say both R&D and G&A will flatten out. We can see if we look at Q3 and Q4 2021, that they were on a similar level and something like that is expected going forward. Okay, thanks. That's very helpful. Then just the last question for me. We're obviously waiting for the biomarker analysis from CAN04 with great anticipation. Could you give us any update on when we can expect results from this? Yeah. That, I completely agree. I'm also very curious. We have taken biopsies from patients, both before and during therapy and are analyzing those. Without, let's say, going into too much detail, but one possibility is that these results will come in association with the updated clinical results during Q2. Okay, great. Yep, that's it for me. Thanks. As a reminder, if you do wish to ask a question, please press zero one on your telephone keypad. Our next question comes from Richard Ramanius with Redeye. Please go ahead. Hi. To start, I had two questions about the Precision Promise trial. Can you tell us something more about the timeline? Do you expect any interim readout before 2027? What do you expect would be the primary endpoint for the trial? That's the overall survival? To start with the primary endpoint for a trial, it would be overall survival. That's absolutely correct. There will be an interim readout between, let's say, the phase II and the phase III part. Since this is potentially pivotal trial, it's difficult to say how much transparency I can give about data between those two phases because we don't want to, let's say, violate the integrity of the trial. I'm obviously. I can be transparent. I don't want to take any risks by communicate too much data prematurely. I think we need to come back on, both, let's say, the time point and the context of when we reach the interim readout. It's probably going to take two years from first patient in to reach that endpoint. Okay. You have two other ongoing trials in pancreatic cancer. How do you intend to go forward with these compared to Precision Promise? Or how could you use them in some way? For example, like, if you would like to make a licensing deal, could you use those data from those other trials? Absolutely. The CANFOUR trial and the CAPAFOUR trial, which are the two ongoing trials in pancreatic cancer, are both open label. Obviously, even though CANFOUR is starting to get pretty big now with 73 pancreatic cancer patients, the primary endpoint is still safety. We will disclose those data during Q2, both whatever we have, which is robust enough. Then the trial with FOLFIRINOX, which, I think, you can say is the alternative first-line treatment. It's a little bit behind, but again, trials are not, let's say, part of the pivotal trials, so we'll be transparent around that and are obviously happy to discuss that with potential partners. Okay, last question. You have, as I understood it previously, been mainly focused on secondary treatments in breast cancer. Your new combination trials with Keytruda would be for the first line. Are you open for or how do you see the most important way forward, secondary or first line in metastatic breast cancers? I think just to get this right, the Keytruda combinations are done in lung cancer primarily or to some extent cervical cancer? I meant lung cancer. The initial Keytruda combination trial was done in patients that had previously been treated with Keytruda, relapsed, on Keytruda. Obviously the idea is to get them to respond to Keytruda by counteracting Keytruda resistance with our antibody. That's one patient segment which I think is very valid for a number of indications. This was primarily a safety trial and very early efficacy trial. The second trial, which is now starting up, is a true first-line trial where we get the lion's share of patients being treated with Keytruda plus chemotherapy today, and we're adding our antibody in order to get more durable responses and higher response rates, leading to a prolonged overall survival in the end of the day. But that's really the plan. You could say that all the information we got from the first trial with Keytruda combination is extremely valuable in the design and interpretation of this second trial. Let's say how exactly if we will take both these opportunities into late-stage development at some later time point or how we're going to do it is very much depending how it reads out and how we prioritize between all our opportunities. Yeah. Of course. I got it. Yeah, those were my questions. Thank you. At this time, we have no further questions over the phone. I will now hand over to Jonas for any web questions. Thank you. There's one additional question. The cash should last another 18 months. Will this change, given the fact that the PanCAN study will be financed through control arm in that study? Yeah. I think first of all, I think it's a question for Bengt, and secondly, at least on my side, there was some kind of disturbance. I think you need to repeat the question. Yeah. Please. All right. I'll repeat. The cash should last for another 18 months. Will this change given the fact that the PanCAN study will be financed through control arm in that study? The line is very poor. Sorry, I can't actually hear the question properly. Yeah. Is it better now? Yeah, maybe. Yeah. The cash should last for another 18 months. Will this change given the fact that the PanCAN study will be financed by them in the control arm for that study? That's built into the cash forecast. Okay. No, no change. Thank you. There were no additional questions from the web then. Göran and Bengt, if you want to give a concluding word. Yes. Thank you so much for dialing in and for following us. We very much look forward to continue our development here in 2022. We certainly believe that we have very exciting times ahead of us. Thanks a lot for your support.