Good afternoon, everyone. Thank you for joining us today, and thank you for your continued interest in Immunovia. My name is Patrik Dahlen. I am the CEO of Immunovia, and I will be presenting the quarter one 2021 results for Immunovia. Next page two. Here you can read our disclaimers and forward-looking statements. I encourage you to read these at your leisure. If I could have the next page, please. Page three. Today's agenda is as follows. I will start by discussing the importance of early detection of pancreatic cancer. Second, I will give you a summary of the Q1 highlights. Here, I will review the blind validation study and the optimization study that were presented in Q1. Thirdly, I will touch upon the road to reimbursement and reiterate how we see that process going forward. Next, I will discuss the market opportunity for our blood-based test, IMMray PanCan-d, in the U.S., with a particular focus on the market size for the familial and hereditary risk group. I will then touch upon our pipeline projects in discovery stage, after which I will touch upon the financials for Q1 2021. Following the financials, we will go into a Q&A session. Next page, please. Page four. I wish to take this opportunity again today to remind everyone how important a mission we're on here at Immunovia. With our blood test, IMMray PanCan-d, we will provide an entirely new solution for early detection of pancreatic cancer. Early detection of pancreatic cancer is critical for improving the survival of the pancreatic cancer patients. When pancreatic cancer is detected in stage 1 and 2, the five-year survival significantly improves. It goes to 50% survival rate after five years, compared to less than 5% when pancreatic cancer is detected at stage 3 or 4. Today, the median survival rate for a newly diagnosed pancreatic cancer patient in Europe is as low as 4.6 months. The reason for this is simply that 80% of all pancreatic cancers detected today are diagnosed too late, in stage 3 and 4. Pancreatic cancer tumors at stage 3 and 4 are not resectable, which is the cause of the high mortality rate of pancreatic cancer. Surveillance programs for high-risk individuals based on imaging techniques such as CT, MRI, or EUS for high-risk individuals are currently in use in many parts of the Western world. There are many drawbacks within the current programs, namely high cost, lack of available imaging capacity, time inefficiency, geographic challenges, et cetera. This leads to the programs being limited in scope. A blood test like the IMMray PanCan-d will significantly change the paradigm for surveillance, in our opinion. This opinion is supported by key opinion leaders in the field. Next page, please. Page five. Now I will move to discuss Q1 2021 highlights. Next page, please. Page six. Quarter one of 2021 was a very busy quarter for Immunovia. We reported early in the quarter that we had collected the samples that were necessary for the blinded validation study. Late in quarter one, we reported the results from the IMMray PanCan-d blind validation study. I will go further into the results in my discussion today, as it requires a deeper dive than a one-liner. Furthermore, we reported that we in PanFAM-1 have collected samples in a large cohort of more than 1,300 individuals with familial hereditary high-risk profile. Altogether, we have collected more than 3,000 samples from these individuals collectively. We also reported results from the optimization work that we have performed in our R&D department here in Lund, Sweden. We saw a significant improvement in results when we tested a small cohort of symptomatic risk patients. I will make a dive into those results later in this discussion as well. Next page, please. Page seven. After the close of the quarter, we had a few events worth mentioning. We have submitted our CLIA application to the CLIA office in the state of Massachusetts. Furthermore, we released an update on the market size for IMMray PanCan-d in the U.S. I will go into more details in today's discussion. We have reiterated our view on the road to reimbursement, which I will also discuss in more detail today. If I could have the next page, please. Page eight. We reported the results from the blinded validation study performed at Immunovia, Inc. in our lab in Marlborough. This was a multicenter case- control study covering 591 patients' serum samples. The serum samples were collected from 11 different sites in the U.S. and in Europe. We had altogether 167 PDAC samples, of which 56 stage 1 and 2 patient samples. We included 203 controls from the familial hereditary controls from the PanFAM cohort. This was the first time we had used a control group with the relevant family history and/or genetic traits. We also included 221 healthy controls or blood donors, mostly collected from U.S. sites. If I could have the next slide, please. Page nine. We obtained excellent results for early stage 1 and 2 PDAC patients versus the familiar hereditary control group. We saw an accuracy of 92%, specificity of 98%, and a sensitivity of 85%. Again, I want to emphasize that the specificity and sensitivity is given for stage I and stage II patients. This is absolutely outstanding results and shows that the test has a high sensitivity for early stages of PDAC, which gives us the confidence that the clinical performance of our test meets the market requirements. If I could have the next slide, please. Page nine. I have recently had the pleasure of meeting with a number of experts and key opinion leaders in the field, and I have listed some institutions or universities on this slide where the experts come from that I have discussed with. We have discussed extensively the role of IMMray PanCan-d as a test for surveillance of the familial hereditary risk group, and the feedback has been very positive. For instance, in one discussion, the initial reaction was, "These are the best data ever reported for detection of early stage 1 and 2 PDACs versus controls in a familial hereditary risk group." Obviously, many of the key opinion leaders want to see the IMMray PanCan-d test performance in their own surveillance groups and on their own at-risk patients prior to making public statements. However, I have the pleasure of sharing some quotes from some named key opinion leaders with you today. Dr. Stephen Pereira from UCL, University College London, commented, and I quote, "A blood test for early detection of pancreatic cancer with the performance reported in the blinded validation study fulfills our criteria for a test to be used for monitoring of high-risk familial individuals." End of quote. Furthermore, we hear from individual physicians who see at-risk individuals in the U.S. The interest is very high for our test. For example, Dr. Burns from Wellesley Hills, Massachusetts, comments, and I quote, "As a personalized care physician, I look forward to offering my familial pancreatic cancer risk patients the IMMray PanCan-d test, a clear-cut and informative blood test option to help allay their fears and enhance their own pancreatic high-risk surveillance." End of quote. The interest for our test among private U.S. persons who have had pancreatic cancer in the family is also increasing. They are contacting us at an increasing rate. The recent seminar called Latest News in Early Detection of Pancreatic Cancer, organized by the patient advocacy group Pancreatic Cancer Action Network, has certainly sparked interest as well. In this seminar, Dr. Rosalie Sears from the Brenden-Colson Center for Pancreatic Care expressed her enthusiasm for our blood-based test. It has certainly led to increased awareness among individuals with a family history of pancreatic cancer. I can just summarize that the support and interest for our test in the U.S. is solid. We are excited to soon be able to help the pancreatic cancer community with the blood-based test for early detection of pancreatic cancer. If I could have the next slide, please. Page nine. 11, sorry. As we explained in our webinar on December 17th, we have dedicated an R&D team here in Lund, Sweden, to look for ways to further optimize the IMMray PanCan-d for use in the symptomatic risk group. We reported in Q1 on a small study we conducted with the improved test. The study included in all 433 patient samples collected from seven different U.S. and European sites. Out of these, 202 samples were from patients with pancreatic cancer stage 1 through 4, and 89 of the patients were from stage 1 and 2. We used 231 symptomatic controls in this study. If I could have the next slide, please. Page 12. The results from the optimization study conducted in Lund in our R&D lab showed an accuracy of 89% and, a specificity of 92%, and a sensitivity of 80% in detection of stage 1 and 2 PDAC patients against a cohort of symptomatics. Again, I emphasize that the performance I refer to is for early-stage pancreatic cancer stage 1 and 2. The performance we saw in this study is very close to the performance we saw in the CTMS study, and it looks like we're back on track with regards to sensitivity and specificity, also in the symptomatic cohort. If I could have the next slide, please. Page 13. We have discussed the results from the optimization study, and we have had positive response from our key opinion leaders. Dr. Grützmann from University of Erlangen, Germany, commented, and I quote, "To detect this very deadly cancer, pancreatic cancer, as early as possible is very important. Therefore, it is very relevant to offer IMMray PanCan-d blood test at GP locations and at gastroenterology clinics. The test will be promoted to existing referring GPs and gastro networks in connection with local regular trainings performed by the university hospital, and the results from this collaboration between GP and gastro clinicians could be published in a main physician journal, Deutsches Ärzteblatt." End of quote. Dr. Pereira from University College London commented, and I quote, "The results presented recently are very encouraging and open the opportunity to further validate the current clinical pathway for patients with early, nonspecific but concerning symptoms suggestive of pancreatic cancer. A minimally invasive test, such as IMMray PanCan-d, which can be made available at primary care level, could help prioritize investigations, accelerate PDAC diagnosis, and reduce the anxiety linked with long waiting times." End of quote. It seems the steps we have taken to improve the performance of the test in the symptomatic risk group has been effective, and we show improved performance, which now again resemble that of the CTMS study results we saw earlier. Next, we need to confirm this data also in our U.S. lab in Marlborough prior to the launch in the U.S. Assuming we see the same results in our lab in Marlborough, we should be ready to release also this test for commercial use in this symptomatic risk group as well in the very near future. Please turn to the next page 14. Next, I will discuss the road to reimbursement. If I could have the next slide, please. Page 15. Briefly stated, we will follow a route which is well established for laboratory-developed tests in the U.S., with a very clear path and milestones. As you all know, we will launch the test as a self-pay test, which is very common in the U.S. The people who order the test will pay out of pocket. In order to get the broadest possible utility, one seeks reimbursement for the test. In our case, this means we will seek a PLA, which is short for Proprietary Laboratory Analyses code, for the IMMray PanCan-d test shortly following the data from the PanFAM study. We will conduct further studies as needed, illustrating analytical and clinical validity and utility. Furthermore, we will monitor and collect clinical data from our ongoing out-of-pocket commercial testing. We will obtain endorsement from key opinion leaders and leading institutions. We will then use all of this data and supporting evidence to build a dossier with which we can seek a local coverage determination from National Government Services, who is the Medicare administrative contractor for Medicare services providers in the New England region of the U.S. We have already conducted one payer study that gave us a lot of detailed information. However, we now start a new payer study with specific focus on Medicare. These studies are important so that we get the latest and best possible feedback from the payers. I again need to emphasize that our test will be for surveillance of high-risk groups, such as the familiar hereditary risk group, with tight inclusion criteria and therefore a well-defined, relatively small population in the U.S. Thus, the test is not seen as a screening test. Diagnostics reimbursement expert David Parker, a senior vice president at Precision for Medicine, comments, and I quote, "Market research indicates that surveillance imaging of patients at high risk for pancreatic cancer is already routinely covered by payers, and it is not considered as a screening application of the imaging modalities. Immunovia will be seeking coverage for the same surveillance use in the same population. It seems highly unlikely that payers will view the IMMray PanCan-d test as a screening test when they cover the clinical alternatives as diagnostic." End of quote. The medical community and the associations that focus on pancreatic cancer in the U.S. have issued several guidelines and recommendations. All of these guidelines and recommendations are against general screening and for surveillance of high-risk groups. The payers obviously listen to the medical community. On the other hand, in terms of the symptomatic risk group, there is obviously no obstacles either to obtain reimbursement for testing patients in the symptomatic high-risk group. In terms of timing, we fully expect to have a majority of the coverage agreements with payers in place by end of 2022. Please turn to page 16. I will make a few comments on the updated market size. Please turn to page 17. Thank you. Organizations such as the U.S. Preventive Services Task Force, National Comprehensive Cancer Network, American Society of Clinical Oncology, and the International Cancer of the Pancreas Screening Consortium make regular updates to their guidelines and recommendations. A number of recent updates have led us to re-examine the potential market size in the U.S. The market opportunity for surveillance of familiar hereditary high-risk group is estimated to 315,000-350,000 individuals annually. This is based on the understanding of the number of new cases per year, disease association due to familiar and hereditary background, an understanding of what's called the average U.S. family of two parents and two siblings, and, of course, the range of the recommended surveillance age, et cetera. This means that the potential market size for Immunovia range from 630,000- 700,000 tests annually, of course, assuming twice-a-year surveillance. Current programs run once-a-year surveillance with MRI and EUS, and we think twice-a-year surveillance could be the future in order to catch stage 1 and 2 as early as possible, as disease progression is fairly rapid. If I could have the next slide, please, page 18. Lifting our horizon into the future, we can see now that several opinion leaders and medical organizations, such as NCCN, are recommending all individuals with a family history to be tested for mutations and included in surveillance programs. This includes persons with just one first-degree relative. Recent publications do indicate that there is a significant ninefold increase of risk of pancreatic cancer among persons with just one first-degree relative. There is an estimated 3.1 million individuals in the U.S. in the surveillance age bracket of 50-80 years with one first-degree relative. It is also fair to state that a blood test-based surveillance would be the only way to deal with such numbers of individuals in a surveillance programs. We are not suggesting this happens in the near future. It is certainly something to consider when we speak about the long-term potential for IMMray PanCan-d in the marketplace. Next page, please, page 19. Briefly on the U.S. high-risk symptomatic group, we maintain our view on the market size here. It is roughly half a million individuals per year, as we have previously stated. If I could have the next slide, please, slide 20. I will say a few words now about our discovery pipeline. If I could have the next slide, please, slide 21. While our main focus is on the launch of IMMray PanCan-d for early detection of pancreatic cancer, we continue to work with our discovery platform. We currently perform early-stage discovery studies in the area of rheumatoid arthritis and lung cancer. We have established key opinion leader networks for these discovery studies, both to secure we have the right knowledge mass and, of course, to secure high-quality samples from well-defined disease cohorts. As you know, collection of samples is still affected by the COVID-19 pandemic. As these are discovery studies, meaning they are in the early stage of our R&D model, it is not my intention to give firm timelines on these two discovery studies today. We will report data when we have new data and information. If I could have the next slide, please, slide 22. Next, I will just have a few words on the financials Q1 2021. Next slide, please, slide 23. Our income in Q1 2021 was SEK 123,000. This income is royalty income, and we've seen this type of levels of income in the past. Net operating earnings were -SEK 23 million in the quarter. Cash flow in the quarter was -SEK 43 million. Cash and cash equivalents at the end of the period was SEK 425 million. Based on past, that is 2020, and current burn rate, we have a run rate of over two years at current full-year levels. We will update our view on cash contributions from sales in our Q3 report, thus giving some more color on our cash position in the years out. This was indeed the last slide that I wanted to share with you today, and I want to turn to the next page, 24, and we can open up the call for questions and answers. Thank you. 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. There will be a brief pause while questions are being registered. I remind you that if you want to ask a question, please press zero on your telephone keypad now. We have a question from the line of Lars Hevreng from Danske. Please go ahead. Your line is open. Yes. Thanks. Maybe I missed that in your remarks, but can you just elaborate a bit on the pacing of the events here? The second quarter, the launch, the early target groups, and what you can say in terms of early adopters, the number of hospitals or physicians that you would address, so we could have some color of how, from the next quarter results onwards, this will be seen as a commercial stage company, and how we should assess the level of success. Yes. Actual commercial testing, meaning that we can also invoice for the testing that we're doing, will commence as soon as we have a clear number. That should happen within weeks, within a very short period of time. We are truly expecting that to happen within May month. The first target group is obviously familiar hereditary risk individuals. Many of these are coming to us as private individuals, either directly or through their primary care physicians. Obviously, also, there is a great deal of interest amongst already established surveillance programs that are running across the U.S. There is roughly 60 well-established surveillance programs around the U.S., and included in continuous monitoring in those programs is roughly 10,000 people. That gives you an idea of the immediate target groups, so to speak. As we have said, we estimate that the total number of people in the U.S. that have a familiar and hereditary risk profile is roughly 315,000 to 350,000 individuals. Obviously, we will work very diligently to identify these individuals and target our marketing and sales efforts towards these. With regards to the symptomatic risk group, obviously, now with the data we have from our R&D lab in Lund, we are going to confirm that data in the U.S. in our lab there. Once that is confirmed and they've run their study there, then we will be in a position to launch IMMray PanCan-d also for symptomatics. The customers there are primarily in the gastro centers. As you know, we have established a sales force for dealing with particularly gastro centers. We have a group of five people in the sales force who will be focusing on the East Coast gastro centers to begin with. It's a little bit early still, I think, to comment too much on how we see sales in Q2 and how we see sales in Q3. I think I'd like to see exactly the take-up and the run rates going here. All I can say and comment on is that the influx of inquiries is steadily increasing day by day as we move close to being able to actually commercially launch. Okay. That's very helpful. Thanks, Patrik. Just for us to understand the sequence of commercial step-up of activities, the level of activities in the U.S. The last time it was updated in the CMD back in June last year. Can you just tell us, you have five people today, when you're going to expand the scope, and you're going to address the other main areas, such as the West Coast, Florida, Texas, some regions around that, the sequence of events and the scale-up of the organization? I think we'll very safely take a quarter to see how well we progress on the East Coast with regards to the gastro centers there, and be very sure with regards to that we have the pitch right, and that we have the positioning right, and everything is correct. Then we'll evaluate that. I don't think in the third quarter we'll be doing much in terms of building out the sales force. Probably start to look at that for the fourth quarter. All right, I got it. Last question from myself, which country in Europe of size do you think is going to be the first where the product's going to be available? We will update the market with regards to the launch in Europe before the end of this quarter two. As you are aware, the reimbursement landscape in Europe looks very different from the U.S. It's 28 EU countries deciding for themselves, therefore it takes a very significant amount of work to figure out exactly which sequence one should use in order to approach that. On the other hand, we are very close to certain key opinion leaders in certain European countries. Obviously, that will give you a little bit of indication where we will start. The second thing that's happening, of course, from a European perspective, is the CE regulations are changing, there is a new regulation coming, the new IVDR rules, by May 2022. Obviously, that's another thing that we will need to take into consideration as we sort of look forward. Yeah. Okay. I got it. Thank you, Patrik. Thank you, Lars. Our next question comes from the line of Alex Cogut from Kempen. Please go ahead. Hi, Patrik. Thanks for taking my questions. I was just wondering on the highly symptomatic group, how do you plan to expand the reimbursements? What would the next steps be from here? What's become very clear is that there's a little bit of misunderstanding of the road to reimbursement for this particular group. As I think everyone is agreeing that general screening of the population for pancreatic cancer is not advisable, and it's not advisable from the view of the medical community, and it's certainly not something that we would be advocating for either with our blood-based test. Obviously, for us, in terms of obtaining reimbursement, the key is actually to focus on a high-risk group, such as the familiar hereditary group. Within that group, if one wants to further narrow it, there's obviously certain syndromes like the Peutz-Jeghers syndrome that has an extremely highly elevated risk for pancreatic cancer. If one really wanted to pinpoint a high-risk group where it would be very easy and very fast to conduct studies to point to clinical utility, then there certainly are subgroups within the familial hereditary group that we can work with. We have, however, come to the conclusion based on the work that we've done for years now, that the combined familial hereditary risk group is well accepted as a first starting point for surveillance, and therefore it's also a well-accepted starting point in terms of working towards reimbursement. That is actually very much our strategy to work towards reimbursement for this well-defined familial hereditary risk group. Yeah. No, I think maybe I didn't phrase my question correctly, but I'm referring to the symptomatic patients. I know that you plan to redo a study in the U.S. and launch it for these patients. I was just wondering, how do you see getting reimbursement in that broader category? Oh, that group is, of course, equally straightforward, maybe even more straightforward than the familiar hereditary group, in that obviously there the starting point is symptoms. That is, of course, I don't think any contingents are there with regards to reimbursement. Basically, it's the same process as for the familiar hereditary group, i.e., we redo the data in the United States. We conduct some local studies with principal investigators in the United States for the symptomatic group. We collect a dossier that shows clinical utility and validity. With that at hand, we approach the payers. It's very much the same process and roughly the same timelines. Would an additional perspective study be required, given it's a larger population? We don't think so, actually, given that, again, you have a fairly high density of patients, very clearly defined current clinical practices, and we would supplement those with the blood-based test. Don't see that we would necessarily need large, broad-based prospective studies. Indeed, very focused studies for the sort of clinical utility and validity as compared to current practices. We don't foresee long and cumbersome prospective studies needed. Got it. Just another question I have. I know that a competitor of yours received a breakthrough designation for their pancreatic cancer detection test in patients with new-onset diabetes. I was wondering if this would be a path that you are planning to pursue, and if not, why wouldn't you? When it comes to the NODs, which continues for us to be an extremely interesting application for IMMray PanCan-d, I think most recent discussions, whether it be academic or private companies, there's an ever-increasing interest for the NODs, and we're very happy that that's happening because it's also our view that this is another risk group that definitely needs a surveillance approach in order to early catch pancreatic cancer in this group. For us, the next milestone for the NODs is actually running the PanDIA study and getting the first indications of what a NOD group looks like in our hands. For us, that is the sort of next milestone is to report out on the PanDIA and showing what is the performance of IMMray PanCan-d in this particular at-risk cohort. From there, we will then make further projections and milestones with regards to what are the next steps. Obviously, it will look pretty much like what it's looked like in the past for the familiar hereditary group and the symptomatics. Seeking FDA breakthrough determinations for us is not at this stage in the plans, as we, at least for the foreseeable future, will continue to have an approach where we work with laboratory-developed tests. Okay. Thank you. Thank you. Our next question comes from the line of Viktor Sundberg from ABG Sundal Collier. Please go ahead. Hi, thank you for taking my question. First one for me is on the PanFAM-1 study. What expectation should we have on the interim readout going into that event in the second half of 2021? I guess my question is what the study is powered to find in interim study in terms of perhaps number of PDAC cases that IMMray would pick up, that imaging would also confirm. Just in terms of trying to manage expectations for that study, is say two confirmed cases of PDAC a success, or would you say that the number have to be 10 in order for you to use that data to apply for coding and subsequent coverage and pricing? Thank you. I think with regards to the PanFAM-1 study, like with just about any study that pertains to familiar hereditary large-scale studies, whilst one is collecting samples for many years and enrolling large numbers of patients, there's no guarantee that you will hit X numbers of PDAC cases. We obviously don't know that yet. We don't know how many there will be, and we don't know either with regards to how many might there be that have not been detected by imaging at this stage. I think from that point of view, it's obviously too early for me to comment with regards to the power of the study per se. That said, seeing from my chair and with my experience in the field, I would say what is important is obviously to show the clinical performance and the test performance with regards to the test's ability to detect early- stage PDAC in a cohort like PanFAM-1. Obviously, there are many ways to secure that and do that in a way that we're still prospecting, like we've done, and where you just secure that you also get the sort of analytical and clinical sensitivities and specificities at a reliable level. That's kind of how I think about it and how we will be proceeding. Okay, great. Maybe one question on screening or on surveillance. The communication earlier from Immunovia has always been that the familial group was considered to be asymptomatic and would be considered for a screening, and I think that was reiterated late in June. What has changed in your communication with experts that have made you pivot away from this line of thinking? Of course, you are the new CEO of the company, so just curious what you have learned that perhaps previous management missed. I don't want to point on previous management by any stretch of the imagination. I just go by common knowledge and what the medical community are saying, and that is that screening in the area of pancreatic cancer is not recommended. Surveillance is, and that there are given risk groups where surveillance should be conducted and should be conducted based on certain inclusion criteria. This obviously limits the number of persons to a very much smaller group than the general population of the United States. Therefore, it changes dramatically the view on reimbursement and how to distinguish between screening and surveillance. The second thing to say is we've also learned that the current surveillance programs and persons enrolled in those do get their screening process reimbursed by commercial payers. The commercial payers clearly see the processes that are used and the imaging techniques that are used as diagnostic modalities and not as screening modalities. That is another learning, obviously, that is a key here. Yeah. Also, one question here on next steps after this hereditary familial group, after you have secured reimbursement in that group. Do you think that this symptomatic group is the next in line, or would that be the NOD group? Yeah, the symptomatic. Your thinking. Yeah. The symptomatic group we will run in parallel with the familiar hereditary group. That will go more or less hand in hand. Those two risk groups are not far from each other with regards to timelines and ability to obtain reimbursement for. Actually, those two groups will run in parallel. That's how you should think about it, that within 2022, we should be perfectly in place also for the symptomatic group. The group to consider a little bit sort of out of sync with the two first ones is obviously the NOD group. As I said before, very optimistic about the NOD group. It's commercially obviously a very interesting group. I think it's clinically for the sake of minimizing pancreatic cancer cases going forward. It's obviously an extremely important group to be able to establish surveillance for. I think for me, the key is to be able to report data from the PanDIA, because that is actually the establishment of a sort of baseline for us with regards to test performance in that particular clinical cohort. I think it's quite important that we get that settled first before I start looking into sort of long-term views on commercialization for that, as well as road to reimbursement. Okay. Thank you very much. Thank you, Viktor. There are no further questions registered. I am back to the speaker for any closing remarks. Great. Thank you so much, everybody. Thanks for the great questions. Thank you very much for your continued interest in Immunovia, and I certainly look forward to reporting again on Q2 update as we progress. Thank you very much. End of call.