Welcome to the Immunovia Audiocast with Teleconference Q4 2021. We apologize for the delay, w e had a technical issue. The right phone number is on the speaker picture. For the first part of this call, all participants will be on a listen-only mode, and afterwards, there will be a question and answer session. Today, I am pleased to present CEO Philipp Mathieu. Sir, please go ahead. Good morning, and warm welcome to Immunovia's fourth quarter 2021. My name is Tobias Bülow, and I'm heading Investor Relations. With me today here in Lund, I have the Immunovia President and CEO, Philipp Mathieu. When we move over to the Q&A session, we will also be joined by our Medical Director, Thomas King. Regarding the Q&A session after the presentation, I would already now like to ask you to limit your questions to two per person as a start, and then get back in line for a new round. Our operator for today will guide you on how to ask questions. We will end at latest 11, and for your information, this session will also be uploaded as on-demand on the web. With that, I hand over to Philipp. Thank you very much Tobias. I'm very excited to speak to you today. It is my first quarterly call as CEO of this company, and I'm also very excited to actually be at the helm of this company at a time which I think is critical as it transitions from being a development company to a commercial company. With that, I would like to quickly walk you through the agenda for this call. Initially, I would like to give you a recap of what we've achieved in 2021, as well as also dive in a bit more detail in what we achieved in the Q4 last quarter. I also wanna give you an overview where I see the company today after my now four weeks of being the CEO of Immunovia, and also give you some more details on how I see the road ahead evolving. That will be followed as Tobias said, by this Q&A session which I'm very much looking forward to. Moving on to the next slide. Let's recap our 2021 achievements. In March 2021, we announced the successful blind clinical validation of IMMray PanCan-d in the U.S. This study showed to date unmatched performance in detection of early stages of pancreatic cancer. We also received approval for our clinical laboratory in Marlborough, Massachusetts. With that last milestone, we became an early commercial company in August 2021. Now, where did this commercial launch position us as a company? This launch positioned us as the one with the first to market with a blood-based test in the U.S. dedicated to the early detection of pancreatic cancer. Another achievement during the year 2021 was progress we made on various clinical programs, also targeting additional risk groups beyond just the familial group. With that, let's move on to the next slide, focusing a bit more on the Q4 highlights. Q4 was the first full quarter of sales of IMMray PanCan-d for the familial risk group. The feedback which we are receiving and have been receiving throughout since August 2021 from both doctors as well as patients has been very positive. We've made as previously said, progress on various clinical programs, in particular on PanDIA-1, where we concluded sample collection in December last year. On PanFAM-1, where we're now in the phase of analyzing the data and also progressed various exploratory studies in pancreatitis and IPMNs. We've conducted during the fourth quarter of last year, extensive payer studies, which provide us with an informed view on what payers are looking for and what payers need to issue positive coverage decisions. Additionally, in addition to scale our company, we hired a new CFO, Karin Almqvist, who's going to join us in April, as well as hired Tobias Bülow, who is today with me here and next to me as head of HR. We also celebrate the grand opening of our U.S. subsidiary on World Pancreatic Cancer Day. Now, let's move on to the next slide and focus a bit more on financials. During the Q4 of last year, the first full quarter as an early commercial company, we generated net sales of SEK 305 thousand. Of that, I think that's probably the more interesting part, two hundred and seventy-eight Swedish krona were from self-pay tests of patients. As a word of caution, that's the same for pretty much all comparable diagnostic tests in the U.S., I wouldn't read too much into those numbers since for every test which is early commercial and doesn't yet have reimbursement, the initial sales are by no means any indication for the full potential of the test. The net earnings amounted to -SEK 47 million, which is pretty much the same as for the same quarter the year before. We have a solid cash position as of the end of 2021 with SEK 287 million. With that, I feel we are well capitalized for our current plans in executing those. Just to repeat, we expect testing to significantly increase once we have reimbursements, and our vision is still to have reimbursement in place, at least for early reimbursement decisions by the end of this year. Until then, we expect the volumes to be rather moderate. Let's move on to the next slide. Now how's the company positioned today? I see the company very well-positioned as a front runner in innovative pancreatic cancer testing. Our tests, and that's validated by various studies, has a specificity of 99% for both early-stage cancers, but also across all cancers, and a sensitivity of 89% for early-stage cancers, versus a sensitivity of 92% for all stages of cancer. What we hear again and again from doctors as well as from patients is how much they appreciate that it's a non-invasive test that doesn't require anesthesia, so they really appreciate the ease of use. With that, we are the first-ever diagnostic test which is purely focused on the early detection of pancreatic cancer. We are the first blood-based pancreatic cancer surveillance test available in the U.S. We also believe that we have not only a favorable performance, but we also can offer our test at a cost and at a price point which is way below currently available diagnostic methods for pancreatic cancer, mainly MRI and CT in the U.S. Let's move over to the next slide and give you a bit more detail on some of the numbers which you already know, but also some of the numbers which you cannot repeat often enough to talk about how big the unmet medical need actually is for pancreatic cancer, which we are targeting. Every year in the U.S., you have 60,000 new cases of pancreatic cancer, but also every year, you have 48,000 deaths due to pancreatic cancer. If you find pancreatic cancer early, which only happens in less than 20% of all pancreatic cancers diagnosed, you actually have a survival rate of 42%. If diagnosed at a later stage, not in stage one or two, you have a survival rate of only 3%. Now, that also is the mission of Immunovia to exactly change those numbers. It is our mission to make early detection of pancreatic cancer broadly available to all patients. Let's move on to the next slide and talk through all risk groups which we are targeting with our IMMray PanCan-d test. The initial risk group is the familial risk group, which you're well familiar with, where we're commercializing, which has an estimated market size in the U.S. only of $500 million. For that risk group, we have extensive clinical evidence. The last one, and probably the most valuable one in validating our test is the validation study, which was just announced. The next steps for this is the full publication of that validation study, as well as the PanFAM-1 results, and I'll spend a bit more time talking about where we are on those in a second. The ultimate goal for us, and the ambition here is to have early positive reimbursement coverage decisions in place by the end of the year, is obtaining coverage for as many patients as possible as soon as possible. Moving on to the next risk group, the symptomatic risk group. This is a risk group which we estimated to have a market size in the U.S. only of $400 million. We have a variety of studies to provide clinical evidence, but we are not yet commercial. The last study, which we embarked on is PanSYM-1, and I'll talk about where we are on that. The last risk group is the risk group in new-onset diabetes patients. The estimated market size, as we talked about previously, is $3.1 billion. The clinical evidence we have is mainly our ongoing PanDIA-1 study, which completed collection of samples at the end of 2021. We are not yet commercial, but we target to be so in the future. A major step on that pathway is the finalization of PanDIA-1. Here specifically, we are currently in the process of analyzing the samples and collecting the relevant patient records. Moving on to the next slide and giving you a bit more detail on the most important projects as of today. PanFAM-1. On PanFAM-1, this is a study for which we expect results to be disclosed in mid-2022. PanFAM-1 is a multi-center prospective study for early detection of pancreatic cancer in the familial risk group. To give you some details which you might already know, in terms of timeframe, we collected samples for that study between December 2017 and April 2021 at 23 clinics in both Europe and the U.S. The aim of the study is to provide clinical performance data compared with imaging technologies, which are the current standard of care diagnostic techniques for pancreatic cancer. The latest status is that currently samples are being analyzed at our laboratory in Marlborough. As said before, we are expecting to be able to disclose results by mid-2022. Moving on to the next slide. PanDIA-1. PanDIA-1 started in 2018, in January 2018, and was back then the world's most comprehensive prospective study targeting that risk group. The target of that study was to collect samples from new onset diabetes patients at time of diagnosis over a three-year period. Now, in December 2021, we concluded that sample collection, and we are currently in the process of transferring those samples to Immunovia for analysis and also obtaining the very extensive patient records relevant for those samples. Again, an update on this one we expect to provide during Q2 of this year. Moving on to the next slide and to PanSYM-1. PanSYM-1 is a study which is intended to target the symptomatic risk group. We started that study in November 2018 as a prospective validation study, and the sample collection was conducted purely in the U.K. at two hospitals. First one being University College Hospital, London, and the Royal Free Hospital. At inception, the target collection size in terms of samples was 2,000, but unfortunately, we were not able to reach that goal due to mainly COVID, and especially due to COVID limiting the number of patients which were able to attend the hospitals and provide samples. Instead, a part of those samples were used in the study, which we announced in March 2021, which showed 80% sensitivity and 92% specificity. We are currently in the process of reassessing our options, how we wanna design future clinical programs which address the symptomatic risk group. Moving on to the next slide. Where are we today? I see the company being very well-positioned for future growth. We have the best-in-class performing tests. We also have the only dedicated test, blood-based for early detection of pancreatic cancer. With that test, we offer a cost-efficient alternative to currently available surveillance methods for pancreatic cancer. Also from everything I've seen, we've got a detailed plan to execute on reimbursement and attaining early positive coverage decisions by the end of this year. What I met when I joined the company was a team, and that applies to both Lund and Marlborough and the U.S. team of very passionate people who all believe in our one mission, and that mission is improving the survival rates for pancreatic cancer. I also saw professional excellence and industry-leading competence across teams on both sides of the pond. With that, I would like to move on to the next slide and spend a bit of time on the reimbursement plan, where we are today and what's the road ahead to get insurance coverage for our test in the U.S. The team has come a long way to put all the pieces in place and reach many milestones on the way there. The two most recent ones being the publication of our peer-reviewed study, validation study, as well as, having more information gathered for the extensive peer reviews in Q4. That enables us to have a very informed view how to be successful in attaining reimbursement coverage. Outstanding on that front are two things. One is results on the PanFAM-1 study, which we expect to have by mid-2022. That all is built up to fulfilling our vision to have initial insurance coverage towards the end of 2022. Moving on to the next slide. We are currently in the process of refining our strategic roadmap for the coming years. Nevertheless, because I think it is important, I wanted to give you already an overview of the strategic priorities I see for 2022. The initial priority for us is to get additional clinical validation for our test, and that applies to all risk groups. We also, and that is critical for being successful commercially in the U.S., we wanna strengthen our U.S. team. We wanna execute, as talked about before, successfully on our U.S. reimbursement plan, and we wanna have a very clear roadmap in place to capture the full potential for our ongoing discovery programs in other indications outside of pancreatic cancer. We also wanna have a prioritization for market access in non-U.S. geographies, while today the U.S. is our only market where we are commercial. In the long term, we wanna be present and wanna be commercial in more than just U.S. All of those priorities which I went through now are going to be key benchmarks for 2022, and my target is to be as transparent and as clear on where we are on each of those along the way. In summary, where are we today and where are we heading? Today, we have the first product launch in the U.S. I see us very well positioned for future market penetration. It is clear that we are at the forefront of addressing a large unmet medical need, the need for early diagnosis in pancreatic cancer patients, and we do that with the best-in-class test. Now, how do we make that accessible to as many patients as possible? We do that by having a clearly defined pathway to reimbursement, which I truly believe we have, which I also believe will be successful in executing. With that, I would like to conclude that presentation, and I'm very much looking forward to Q&A. Thank you Philipp. With that, we conclude the presentation and move over to the Q&A session. Operator, please go ahead. Thank you. Ladies and gentlemen, if you wish to ask a question, you may press zero-one on your telephone keypad. It's zero-one on your telephone keypad. We have our first question from Mr. Alex Cogut from Kempen. Sir, please go ahead. Hi, and thanks for taking my question. I just wanna understand a little bit better, how does the pathway towards reimbursement look like this year? Also including the fact that you are now delayed in reporting the results from Panther. The second part of the question is, you mentioned that by year-end you are aiming to achieve reimbursement coverage, but what level of coverage are you aiming for? Is that the first private contract? Now, when do you expect to be able to achieve coverage for the majority of payers in the U.S.? Thanks. Thank you for your questions. First on Panther. Yes there is a delay, whether it's versus what was previously announced. Nevertheless, talking about the implications as we think about reimbursement, we've planned our path to reimbursement with or without Panther results in either way. Since we don't know today what the Panther results will be, we'll only know, as I said, in the second quarter or in the middle of this year. I think our reimbursement plan plans for both using validation data only, and you saw the peer-reviewed publication in the journal yesterday, which is a big step forward, as well as also using Panther. We see here that we can have, moving on to your next question with regards to reimbursement, early reimbursement decisions in place. I don't foresee to have the majority of payers under contract by the end of this year. This is due to the fact that obviously, first of all, part of that is out of our control. We are going to start after the reimbursement procedures are compiled, and we can use part of the information from our payer studies to have an informed view on who to target first to have those discussions then in Q3 and Q4. Again, to highlight, we expect to have early reimbursement coverage decisions of a positive nature by the end of this year. Yeah. Just to be clear, is PanCan-d required for Medicare coverage? Tom, you wanna take that? No, I think it's not specifically required. I mean, we need to demonstrate clinical utility. I think we can do that based on what exists in the literature in terms of the performance of imaging for detection of early pancreatic cancer and our own validation data in terms of how our tests can detect early pancreatic cancer. Have you validated that view with any sort of CMS affiliates that will be reviewing your file? We have not at this time. We have contracted with an expert in the field, and we're still going through discussions with them. We have, through them, done a number of payer studies where they've interviewed individuals, some of whom are involved with CMS, and have gotten generally favorable reviews in terms of our approach to how we will present our case for reimbursement. Okay. Thank you very much. Thank you sir. Next question is from Mr. Michael Löfman. Sir, please go ahead. Thank you so much. I have a few questions. What is the significance and how will you use the just published double peer-reviewed study in the Journal of Clinical and Translational Gastroenterology? Can you develop a little on how you stand and where you stand regarding the pipeline products and potential new indications? Finally, how is the work of getting a sales distribution agreement in place progressing? I mean, in order so you can start selling to the large group of gastro centers? Thank you so much. Thank you Michael for your questions. I think on the first one, we were very pleased to be able to announce the publication of our peer-reviewed study this morning, which came out shortly before in the journal. That is a big step forward or in terms of two avenues. One is, as mentioned before, it will be part of the file and the case with which we will approach payers. Also, prior to getting reimbursement, I think we have a very good case with which we already now approach surveillance centers with that data, as well as gastroenterologists, to give them more comfort, and that's exactly what they were waiting for, to recommend this test in a broader fashion to their patients and also maximize the potential of IMMray PanCan-d already now before reimbursement. When it comes to the pipeline, Michael, I mean, I think I said that during the presentation. Yes, the pipeline we have, those programs are in discovery mode. We are currently in the process of assessing which options we have to maximize the potential of each of those. I think it's premature to talk about that now, but we'll provide an update, and as you've seen, I've put that as one of the strategic priorities for 2022, not only for us, but also transparently communicating that which pathway we would take for those discovery programs going forward. Then on the last question on the sales and distribution agreement, yes, we are currently evaluating partnering options, but also while having those discussions are very careful to assess that we can, by entering in such partnership, maximize the potential, across those sales channels which we are targeting, those gastroenterologists, surveillance centers, and also PCPs. For me, it is very important that we keep control and keep upside. That means that we build our own sales and marketing organization in the U.S., and where helpful, we'll partner. Thank you, sir. Next question is from Madame Ariane from Baxet. Madame, please go ahead. Next question is from Mr. Ingemar Risela from Private Investor. Sir, please go ahead. Okay, thank you. My question has to do with the cash position. Are you expecting to make any rights issue along the way, or do you think your cash position is gonna be enough for bringing your product to the market? Thanks for your question, Ingemar. Obviously a question of how you define along the way. I don't see any need to have a near-term rights issue. As I said, talking about the cash position of the company, I think we are well capitalized. I also think, the early payer decisions and hopefully positive coverage decisions by the end of the year are possible without the rights issue. Okay. A follow-up question. When it comes to the reimbursement, are you seeing any, like, big obstacles for getting the reimbursement in place, or can we really expect that will happen? Look, I mean the only thing I can say on that one, we feel very well prepared, and we know that we've got a game-changing test which we are bringing forward to the payers. Now there are always risks by doing so, and some of those are out of our control. The one focus for that is obviously what traction and what reactions we're getting from payers. I think we have a good view what to be prepared for. We also have a good view who to approach and which sequence, but there is always a risk. Now what we are focused on is execution. Okay. I'm not so familiar with all the reimbursement work, but can you comment anything about is it a long process to get several on board, or do you I mean, how many people you need to talk to to make this a full reimbursement for the total market potential you have? I didn't understand the question. You mean how many payers we're targeting? Yeah. I mean, how many do you have to talk to on the other side to make the reimbursement happen in the U.S.? Is it one partner or, I mean, is it one company you need to talk to? How many do you need to talk to to get the reimbursement to be able to reach the full potential of the U.S. market? I don't. I'm not really into the- Yeah. No, no worries. No worries. Yeah. No worries. That is a very good question, and it is a whole long list of payers. There is a variety of how many covered lives those payers serve. I mean, Medicare is obviously the biggest one, and there are big private payers, there are small private payers, and each of those have their own committees to approve reimbursement. Each of those also have the technical committees to approve reimbursement for a specific product. It's a long process. But I think if you know who to target and in which sequence, you can so cause a trickle effect and that's what we are trying to do. But it's a lengthy process and you see that with pretty much everybody in every diagnostic test of similar fashion in the U.S., it takes time. Yeah. Are you expecting like a one or two year work to get that to happen, or what is your time, what is your plan there? As I said, we're expecting early initial coverage decisions by the end of the year. Then surely, we won't have the majority of payers ready by the end of the year, but I hope we have a good-sized portfolio of payers under contract in 2023. Okay. Thanks a lot. No worries. Thank you. Thank you sir. Next question is from Mr. Peter Ögren from Private Investor. Sir, please go ahead. Hi Michael and Dr. King. Two questions. Where do you stand on recruiting a dedicated U.S. CEO? Also, how will you change your communication policy going forward? On the U.S. CEO and, as I said during my presentation, scaling the U.S. both from size perspective, but especially from a skill set perspective, is an absolute priority for us. We're in active dialogue and discussions with various promising candidates. I feel quite confident that we'll be able to report on that in the coming months. On the communication strategy, that obviously being my first call as a CEO, it's difficult to promise what I'd rather show you. My approach to communication is to be as transparent as possible. That applies to both internal communication as well as external communication with stakeholders, shareholders and key opinion leaders. I think setting those strategic priorities today for 2022 and having us benchmarked against those, I think is a first step to proactively communicate with shareholders and investors and also be accountable. That's important for me. Okay. Thank you for your answers. Thank you sir. We have no other questions. Ladies and gentlemen, if you wish to ask one, zero one on your telephone keypad. We have no other questions on the phone. Okay. As there seems to be no questions left, we conclude the call. Thanks for joining today, and welcome back next quarter. Thank you very much. Again, I appreciate the interest in the company, but also I'm very much looking forward to having you as part of this journey going forward. Today is only the first step on that journey. Thank you.