Thank you very much. It's a pleasure to present the Cantargia Q1 report today. If we move to slide two, there is some information, and then we can move directly to slide three to introduce myself, Göran Forsberg. I am CEO of Cantargia, and I am here, as we said, together with Bengt Candell, who is CFO. If we move to slide number four, we like to highlight what our most significant events are for this period. Very much has been focused on pancreatic cancer, where we started an extension trial earlier this year, and we will come back a little bit on the purpose of that one. We're also starting a parallel trial in pancreatic cancer where we combine CAN-04 with FOLFIRINOX, in contrast to the first trial where we combined in first line with gemcitabine and Abraxane. During the first quarter, and in the second quarter, we presented new data on our CAN-10 antibody, which is in preclinical development for systemic sclerosis and myocarditis. It was presented at an American Association of Immunologists conference. We're presenting new data, especially in myocarditis, that are very exciting. There's more information on our webpage around that. We also are about to start a trial in triple-negative breast cancer with CAN-04. This is going to be in collaboration with the Spanish breast cancer group called GEICAM. The letter of intent was signed during Q2. This trial, the submission of the protocol, is about to start during the second quarter as well. Finally, we presented new clinical data in pancreatic cancer, which we are very excited about, and we will come back to that in much more detail during this call. If we move to slide number six, you can see how the pipeline in Cantargia around our projects, and especially around CAN-04, has been developing. In pancreatic cancer, we are doing two different trials. We're doing first-line combinations in phase II-A, with gemcitabine Abraxane. As I said, we're about to start a new trial, which will be a phase I-B trial in combination with FOLFIRINOX. Our second lead indication is non-small cell lung cancer. Again, we are in phase II-A, combining with gemcitabine cisplatin, and we'll come back to the news flow. We are very much focusing development on the combination therapies. We are, in addition to what's been done in non-small cell lung cancer and pancreatic cancer with chemotherapy, also doing a trial where we combine with immunotherapy with KEYTRUDA, which is the most important player in non-small cell lung cancer at the moment. That's being performed in the solid tumor trial and performed in the U.S. in a phase I setting. As I said, the triple-negative breast cancer is about to start, and we're also doing other trials which are about to start later on in other cancer forms, which I'll come back to. CAN-10 is being developed for systemic sclerosis and myocarditis. We also have a platform product called CANxx, which is designed to develop new opportunities within our area of expertise. More to come around that later on. If we go to slide seven, this is really the new clinical data we got in pancreatic cancer, and this is done in combination with chemotherapy. I think the take-home messages are really that we see durable responses. That's the first take-home message. The durable responses are very important because patients with chemotherapy alone in pancreatic cancer, even if they get responses, they are often very short in time, and once the patient progress, unfortunately, there are very little alternatives left for treatment. Having durable responses is a surrogate marker for increased survival. With the durable responses and also with something called pseudoprogression, which we have observed in 15% of the patients, we get very promising progression-free survival. Even though it's early days, the survival data looks promising as well. Just a word about what pseudoprogression might be. Pseudoprogression is something which has been well-described with other immune agents, like KEYTRUDA, in, for instance, melanoma and in lung cancer. It has been, let's say, a unique feature of immunotherapy and nothing you expect from chemotherapy alone. In one way, it's really strengthening us in our belief that our drug makes a difference for these patients, and it's also something which can be observed to have long-term effects. If we go to slide number eight, we can actually illustrate what this pseudoprogression means. I think if you just look at this patient, which is called subject one, it's pretty clear that if you look at the blue line here, that the patient has a significant tumor burden when at the zero week, which is usually when treatment starts. The tumor burden is increasing in the first CT scan, which is done two months later. Since the patient is responding on the biomarker called CA19-9, and also felt much better clinically, it was decided that the patient should continue therapy anyway. What you'll see then is that patient's tumor is actually shrinking and that biomarker goes further down. This patient has now been treated for 14 months, and is still on therapy and is doing very well. This is a very successful outcome of the therapy. You have different patterns, but in principle, it's the same story in subject two, three, four, and five. They all increase in tumor size initially, and then the situation either stabilizes like in patient three or improves like in the other patients. In the end of the day, all these patients seem to benefit from the therapy, which is obviously magnificent in this type of disease. If you go to slide nine, this is just showing the results on progression-free survival, where patients have 7.8 months. Right now, there are still some seven patients being treated, so this number can change a little bit. 7.8 months is much longer than you would expect from chemotherapy alone, where it's somewhere between 5.5 months has been described previously. This is a significant difference. The overall survival here is even earlier now. We have seven patients on treatment, as I said, and actually 58% of the patients are still alive in this analysis. This is preliminary data, but the overall survival is 12.6 months, which is much, much longer than approximately eight to nine months the patients are expected to live on average using chemotherapy alone. All those data makes us very excited. If we then go to slide 10, I would just like to comment on the safety in the trial, because that's just as important. What we see when we do treatment is that one of the side effects, or actually two of them, are more pronounced than you would expect from chemotherapy alone, and that's neutropenia, and then something called febrile neutropenia, which is an infection as a result of the neutropenia. Since this was the first-in-man trial, we didn't do anything to proactively counteract side effects. It's important to document side effects. What we do nowadays is that we add some pharmaceutical called G-CSF of proactively to the patient, and the neutropenia is, let's say, much is under control right now in patients treated right now. In this set of patients, we didn't include G-CSF in the same way, and therefore neutropenia and febrile neutropenia was higher than expected. Having said that, this was easily treated with G-CSF and antibiotics, and the patients could continue in the trial. On the very positive side on the side effects are that there are serious side effects on tumor-related or chemotherapy-induced fatigue and neuropathy, and these side effects were much lower with the therapy, and that could be explained by CAN-04 actually being anti-inflammatory and, for instance, counteracting neuroinflammation. We need to study this in much more detail, but in reality, it means that patients do not have to stop chemotherapy, which is a major problem with in pancreatic cancer. Even if patients are responding, they have to stop therapy for a while because of neuropathy. Now they can continue, which makes them much more likely to respond. Altogether, we are very intrigued and very positive to see the data we've seen, and obviously, we are planning on next steps now in pancreatic cancer. If we go to slide 11, we have not updated the market on non-small cell lung cancer for a while, but these are data we presented in autumn last year, and it's nine first patients with non-small cell lung cancer. To summarize, the patients are also here doing very well. Actually, all nine patients had tumor shrinkage when they were treated with CAN-04 in combination with gemcitabine/cisplatin. Six of these patients have a tumor regression which is higher than 30%. One patient has a complete response. That's the patient that had initially been treated with immune therapy and no longer respond. That patient was then given CAN-04 and chemo, and both the primary tumor and lung metastasis vanished within two months, and the patient has been tumor-free for a year in this analysis. Obviously, a very interesting result, and it fits with our strategy too, that CAN-04 and chemotherapy were combined very well. If we go to slide 12, we can just look at our current trials and what the milestones are. In non-small cell lung cancer, in the ongoing trial, we expect the recruitment to be finished in hopefully not too far away, and that we can present the results during Q3. In pancreatic cancer, in the ongoing trial, we presented results last week. Obviously, we expect to give you more information during the second half, especially the overall survival. We are also doing an extension phase right now since the regulatory authorities will require slightly more information regarding treatment to different dose levels, for instance. There are also some other fine-tuning as well as adding CMC stuff. We're doing an extension phase right now, and we expect that one to be fully recruited during Q3 as well. We have our second trial, which is a combination with KEYTRUDA. Recruitment is ongoing. We expect to be fully recruited during Q3, obviously results sometime during the second half of this year. We have the new trials which are about to start. In pancreatic cancer in first-line combination with FOLFIRINOX. We are awaiting regulatory approval, we expect first patients in during second quarter. We have the triple-negative breast cancer and the collaboration. We are doing it with the Spanish Breast Cancer Group. We expect submission during Q2. Finally, we have some kind of basket life trial with three different cancer forms and three different chemotherapies. We are preparing for submission, the plan is to submit during Q2 here as well. With that, I have tried to give you some flavor of what happened during the period and on what the direction in our clinical programs are. By that, I would like to hand over to Bengt, who can go through the finances. I think that would be slide 14. Correct. Thank you, Göran Forsberg. The financial overview. There are two takeoffs from the finance part, the first one is on this slide, and that's Cantargia increasing its investments in R&D. We are increasing operating expenses with 83% Q1 compared to last year to SEK 73.2 million. As can be seen in the graph to the left, this increase is related to R&D entirely. The R&D also accounts for the major parts of the operating expenses, 94%. The increase itself is as before, I would say, related to CAN-04, and especially the clinical studies, CAN-04 and CIRIFOUR, and CMC related to that. We can also see that the preclinical studies in CAN-10 is increasing. To match these increased activities, we're also increasing our staff. End of March, we had 19 full-time employees. Next page, please. We have the second takeoff in the financial position. We have continued, I would say, a very strong financial position with a solidity of 94%. The total available funds, which meaning cash and short-term investments end of March this year, is SEK 842.4 million. This will take us approximately two years with present plans and full speed ahead. This concludes the financial overview. Back to Göran. Well, thank you, Bengt. Let's go to the final slide, which is then just showing the news flow. I think this is just more or less a summary of what I presented beforehand. I would leave this one as some kind of inspiration for questions. The only remark I would like to make is that besides all the clinical news flow you should be expecting over the next six to nine months. There is also news flow from the second product, CAN-10, where we expect to present more pre-clinical data during the second half and around new disease models. The plan is then to initiate the clinical trials early 2022. Thereby, I'd like to thank you for attention, and I'm very happy to answer any questions. Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero one on your telephone keypad now. That is zero one to register for a question. We have a question from the line of Mark Ramberg from Oppenheimer. Please go ahead. Your line is open. Hey, thanks for taking the question, and congrats on the forward progress. Just on the topic of pseudoprogression, I'm wondering if you saw evidence of this also in the non-small cell lung cancer cohort, and if not, why not? Also in the pancreatic patients, were you able to confirm pseudoprogression with biopsy or see evidence of inflammation by any other means besides simply the CT scans? Thanks. Thank you, Mark. I think these are great questions. The first question, when it comes to non-small cell lung cancer, we haven't seen any pseudoprogression. The reason is that we haven't seen any progressive disease whatsoever initially. All the patients have got tumor shrinkage to start with. It's a small patient number, so I think we need to, let's say, look into a bigger patient population to see if we see pseudo progressive events. We need to come back to see if there's a difference between the different chemo combinations or different diseases here. Right now, all patients have benefited with tumor shrinkage. The second question is, have we seen, let's say, evidence for tumor inflammatory response in biopsies? We are currently performing all these analyses, so we have not been able to conclude all the data, and there are still biopsies being analyzed. We need to come back on this issue. It's intriguing if we can see it. Got it. Thanks for taking the question. We have a question from the line of René Bouwman from Kempen. Please go ahead. Yes. Hi, Göran, and thanks. Thank you for taking my question as well. I actually have a couple. First one is actually a follow-up question from Mark's question. Regarding the pseudoprogression, did you see this phenomenon also in the primary tumor? I think the scans that you showed were from liver metastasis. Have you seen this in the pancreas as well? As I recall, the data that was presented here is obviously the sum of all the target lesions. I have to go back just to see what the data looks in the primary tumor. As I recall, we've seen this was pronounced both in the primary tumor as well as in the metastasis. Okay. That's clear. The second question is about the monotherapy arm in the CANFOUR trial. When do you expect to present the biopsy and biomarker data for this arm, and what can we expect from this update? Can you remind us on why these results are important to have? Yeah. I had hoped just to give you some guidance here, but the biopsy analysis has taken much longer time to perform than originally planned. What we're trying to achieve in the, let's say, both in monotherapy as well as in combination therapy, and then also to compare these, and then compare with what we can see on the CT scan and what we can see when it comes to biomarkers in the blood. It's really to make all these correlations that's important. First, primarily from a mechanistic action analysis point of view. Hopefully we can see that the inflammatory or anti-inflammatory responses in the blood can also be correlated with something happening in the tumor. Also, if there are, let's say, responses in the pseudoprogression, which I think is even more important to understand what's happening inside the tumor in these cases. Trying to, let's say, get that puzzle ready is what we're trying to achieve. I think this is the type of data we will present at the scientific conference when ready. All right. That's clear as well. Just one last question around the extension part in the PDAC CANFOUR part of the trial. You expect to finalize recruitment in Q3, and this is about one year behind the last patient enrolled in the main study. Do you expect to have top-line results for the extension part around this time next year then as well? As a follow-up to that, I think we spoke about it last week during the R&D Day as well already, do you believe you will be able to start a phase III with CANFOUR in combination with gemcitabine in this setting already before you will have the results of the extension part, or would you have to wait for these results? Yeah. That's a good question. The extension part has primarily been designed to provide additional, let's say, safety data on various dose levels as well as some more safety data on G-CSF. The plan is not really to include the long-term efficacy data in the preparations of a phase III trial. The plan is really to go ahead and have regulatory interactions basically based on the data set we have right now and on the safety data that is reading out from the extension phase. Obviously, we will have more data next year to present. That's absolutely fair. Okay. That's very clear. Thank you very much, and congratulations on the progress. Thank you so much. I remind you that if you want to ask a question, you will have to press zero one on your telephone keypad now. We have a question from the line of Sean Conroy from Edison Group. Please go ahead. Hi there, thank you for taking my questions. Firstly, just regarding the ongoing KEYTRUDA combination study. You guided for recruitment to complete next quarter, I was just wondering if you could give any insight as to what specific types of cancer you've seen predominantly being recruited into the study. Following on from that, just generally how you're thinking about investigating PD-1-based regimens going forwards. Yeah. That's another great question. The trial is primarily designed to investigate the safety and let's say, obviously biomarkers and early efficacy, but it's done in relatively up to 18 patients. We're recruiting four different indications, non-small cell lung cancer, head and neck cancer, melanoma, and bladder cancer. So far, we got recruitment in all of these cancers except bladder right now. It's a pretty even distribution between the others. What are the next steps? Obviously we need to see what the data looks like, but one thing we have already said that once we have the safety data with the PD-1 combination, and since we have safety data with the platinum combination, we will go ahead and explore platinum, KEYTRUDA and CANFOUR as one next step. If we see signs of efficacy or let's say biomarker effects with the PD-1 combination only, we need to take the next step into appropriate testing of that combination as well, but more to come. Excellent. No, thank you. Are you able to just confirm what you think the cash runway is going to be, just given the new trials that you recently announced you're going to start? All these trials we are talking about are part of a financing plan. We have about a two-year runway right now. Excellent. Thank you. Yeah, congratulations on the recent results. Thank you so much. Our next question comes from the line of Josefine Persson from Nordea. Please go ahead. Hello. Thank you for taking my question. Another question on the ongoing CANFOUR study. You presented a median survival of 12.6 months, which is about 48% better than 8.5 months with the chemotherapy alone. In the CMD, you mentioned that the expected improvement in median survival needs to be about 50% to become standard of care. Can you elaborate a bit more on that and what improvement might be needed for regulatory approval? Yeah. That's good. I think the question at the Capital Markets Day, or at least how it was interpreted by our key opinion leader, was whether with this about 50% improvement would be good enough to become standard of care, and he was of opinion that that was the case. Normally, you're talking about hazard ratio of 0.75, sometimes 0.8 if for certain circumstances, and then it's also dependent on what the safety and other parameters look. As a rule of thumb, the hazard ratio of 0.75, which would be somewhere over 25% present the improvement in overall survival is what regulatory authorities are looking for. For us, we need to have those discussions with the regulators before we can go out and guide. Okay, good. You expect a 25% improvement needed for regulatory approval, at least? Yes. Yes. Thank you. Our next question comes from the line of Niklas Elmhammer from Redeye. Please go ahead. Yeah. Hello. Good afternoon. Thank you for taking my question. I am just wondering about the cancer or the lung cancer arm, if you have any comments on the recruitment. I know you had some challenges in recruitment before, do you have any update on that? Yes, it's definitely correct that it's much easier to recruit the pancreatic cancer patients than lung cancer patients. I think there are several reasons why lung cancer has been challenging. Competition is one, and COVID has definitely been one since, let's say, the hospital resources for treating COVID patients very much overlap with the same resources taking part in clinical trials in lung cancer. We do recruit patients, and as said, we expect recruitment to finish in hopefully not too far away from now. The patients seem to come not, let's say, individually one by one at the, let's say, predefined frequency. We cannot guide, but we expect to present the data during Q3 for sure. Okay, great. Just clarification if I heard you correctly that premedication for this neutropenia side effect, what you have seen so far, I believe you said they were promising. Yes. What we do, in, let's say, the original pancreatic cancer population where we present the data, we did not attempt to proactively counteract the neutropenia. Instead, the patients were treated with G-CSF as a reaction to neutropenia. What we're doing in the extension phase and what we're doing now in the lung cancer phase is to proactively give G-CSF before they enter into, let's say, serious neutropenia. That seemed to be doing the trick. We need more patients, then we're ready to present the data. Okay. Thank you. Thank you. There are no further audio questions registered, so I hand back to the speakers. There are two questions coming in through the web, and I think you've been touching upon the first one. Could you please again tell us when you expect to release the next update on the PDAC study, and will that be the final phase IIa data? Yeah. We're expecting an update during the second half for sure. If you think about it, the last patient entered the trial in early October last year. We have a median survival of more than 12 months right now. Obviously we need to follow all patients for more than 12 months before we can make the final conclusion on what the survival would look like if it's going to be more than a year. Then there are seven patients still on therapy, and that can still, on a positive note, influence efficacy parameters here. We need to say it's too early to say if it's going to be the final data, but I think it's going to be, let's say, a very complete data set even though not completely final during the second half of this year. Thanks. The final question is you've been talking about interactions with the regulatory authorities. Could you please describe which ones those are? Yeah. Ahead of, let's say, starting pivotal trials, there are really two paths here we need to go. One is with the European Medicines Agency where you have something called a scientific advice, which is quite long process. The second is to have what's called an end of phase II meeting with U.S. FDA. Ahead of those meetings, you can have other types of meetings as well to clarify some technical questions, and there are also, let's say, lots of questions to be clarified when it comes to production and things like that. There will be a number of interactions between us and those two regulatory authorities, let's say, during the end of summer and during the autumn and perhaps winter. We will try to be, let's say, transparent at least around the more important ones because that's really what's deciding what the next step will be here in our development. As a company, we are committed to go ahead as quickly as possible in collaboration with regulatory authorities. Okay. Those were the questions that were coming in through the web. Thank you very much. Thank you. If there are no further questions, I would really like to take the opportunity to thank you for your attention. I look forward to continue to present data, and I'm sure there'll be more to come here. We have a good news flow ahead of us. Thanks.
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