Thank you, good afternoon, everyone. Thank you for joining us today, 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 full year 2020 and quarter four results for Immunovia. Next page 2. Here you can read our disclaimers and forward-looking statements, and I do encourage you to read these at your leisure. Next page, please. Page 3. 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 full year 2020 and the quarter four highlights. Under this agenda point, I will discuss the status where we are right now with introduction of the IMMray PanCan-d test and the road to reimbursement. I will then briefly touch upon our pipeline projects in discovery stage, and I will equally briefly touch upon the financials 2020. Following the summary, we will go into a question and answer sessions. Next page, please. Page 4. I wish to take this opportunity again today to remind everyone how important the mission we're on here at Immunovia. With our blood test, IMMray PanCan-d, we will provide an entirely new solution to 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 today are detected too late. They are detected in stage 3 and 4. Next page, please. Page 5. Now I will move into the full year 2020 summary and discuss quarter four highlights. In this section, I will also discuss the current status of IMMray PanCan-d and the road to reimbursement. Next page 6, please. Year 2020 was a very eventful year for Immunovia. We saw many successes and one challenge. We saw outstanding results from the IMMray PanCan-d verification study, and I will go into that further in my discussion as it requires a deeper dive than a one-liner. In June, we had a very successful direct share issue. We raised SEK 400 million in the direct issue, and I want to thank all our shareholders for the support to Immunovia. This capital increase will secure that we can successfully launch IMMray PanCan-d to the U.S. market and beyond. In a webinar in June, we communicated our long-term goal of achieving 30% market penetration in the clinically relevant areas where the IMMray PanCan-d test can be applied to detect early-stage pancreatic cancer in three risk groups. These risk groups are familial hereditary group, symptomatic group, and the new onset diabetics type 2 at age 50 or over. We, like many other companies that conduct clinical studies, were in 2020 affected by the COVID-19 pandemic in a way that one might not have anticipated. Many patient blood collection sites closed fully or partially in longer periods of time during the spring and the fall of 2020. This impacted our ability to get all the necessary blood samples for our studies in time, thus this impacted the launch of the IMMray PanCan-d test from quarter four 2020 to quarter one 2021. On the 1st of November, I became the CEO of Immunovia. I do wish to thank the board of directors of Immunovia for the trust they have shown in me. I'm really excited to be here at this time. It's an important time in Immunovia's history. We are right in the midst of the commercial launch of our first test. Next page 7. In quarter four, we discuss the results from the verification study. This was a multi-center case control study covering more than 500 patients. Serum samples were collected from nine different sites in the U.S. and in Europe. We had 81 PDAC stage 1 and 2 patient samples. We had 114 PDAC stage 3 and 4 samples. We had 212 healthy controls and 112 symptomatic controls included. We obtained excellent results for the early-stage 1 and 2 PDAC patients versus healthy controls. The accuracy was 94%, specificity 99%, and the sensitivity 78%. This is an absolutely outstanding result and shows that the test has a clinical performance that is meeting the market requirements. For early-stage 1 and 2 PDACs versus all controls, we saw an accuracy of 91%, specificity of 93%, and a sensitivity of 78%. We are very pleased with these results, and this shows that IMMray PanCan-d can detect in serum samples early stage 1 and 2 PDACs with a high accuracy. In a webinar in December, we discussed in more detail the results, and we concluded that we had seen a slightly less specificity for the test when we tested against the symptomatic controls, 81% specificity. Once we saw the same sensitivity, that is 78%, in early stage PDAC 1 and 2 patients were tested versus the symptomatic group. As concluded in the webinar, we're working on a small quality improvement to help step up the specificity when we measure serum samples from the symptomatic group. This work is progressing. Continuous test quality improvements is routine in the development phase and even after market launch, and is expected for any diagnostic test. Next page 8. Where we are now is in the final steps of launching the test. The last and final milestone prior to launch is the validation study, which we will have results from by the end of this quarter, that is quarter 1 2021. When we have that data, we will file for a CLIA license. Next page 9. We have been working towards the launch of IMMray PanCan-d for many years, and we are excited that we now are so close to introduce the test to the market. The Immunovia Dx lab in Marlborough, Massachusetts, U.S., is in its final preparations for the blind validation study and applying for a CLIA license. All the logistics for handling of reagents from Sweden to U.S. is in place. The logistics for handling and collecting serum samples from patients is in place. We have a customer support and a sales support group in place in the U.S., and everyone is getting ready and making final preparations. A final marketing and communication plan is in place, and we will just need to push the button. A sales rollout plan is in place, and the key clinical target customers have been identified. As you know, we work with most of the clinicians who are engaged in pancreatic cancer in the clinical programs. We know who the customers are. We also have worked extensively with patient advocacy groups in the U.S., and also through them, we will get an excellent communication support and awareness. We have worked on a reimbursement program since 2015, and we have a clear path forward. I will discuss that on the next page. Please turn to page 10. Briefly stated, we will follow a route which is well established for lab-developed tests in the U.S. This has a clear path and clear milestones. As you all know, we will launch the test as a self-pay test. This is very common in the U.S., and 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 that we will seek a PLA code, PLA is short for Proprietary Laboratory Analysis code, for the IMMray PanCan-d test shortly following the data obtained from the PanFAM-1 study in second half of this year. We will then conduct further studies as needed, illustrating analytical and clinical validity and utility. Furthermore, we will of course 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 use all of this data and supporting evidence to build a dossier with which we can seek a Local Coverage Determination, or LCD, from the National Government Services, or NGS, who is the Medicare Administrative Contractor, or MAC, for Medicare services providers in New England region of the U.S. This is the process that many have followed before us. This is a well-recognized path for a reimbursement. We have already, back in 2019, conducted one payer study. It gave us a lot of valuable information. However, we will now start a new payer study with a very specific focus on Medicare. These studies, that is, the payer studies, are extremely important so that we get the latest and best possible feedbacks, and understand the landscape best possible way. With that, I'd like to turn to page 11. Our main focus, 100% focus, is right now on the U.S. launch. The next wave will be Europe. As you all know, we have a fully built-out Immunovia Dx lab also here in Lund, in Sweden, and that lab will serve the European market. More details will follow on the timelines. With that, I would like to turn to page 12. Immunovia has been extremely active over several years building a key opinion leader network that can help us with large studies. We are very grateful for the support from our key opinion leaders around the world. PanSYM-1 is a study where serum samples are collected from individuals with early and vague symptoms. This collection is led by University College London, and they are collaborating with diagnostic centers around the U.K. We have already altogether more than 2,000 samples collected from this study and expect to report interim results in the second half of 2021. The PanFAM-1 study is a study where samples are collected from individuals who are asymptomatic or, in other words, healthy. However, they have a familiar and/or a hereditary risk profile. 23 pancreatic disease reference centers from the U.S. and Europe are participating in this study. We have collected more than 3,000 samples by now and have little less than 1,300 individuals enrolled in the study. Interim analysis from this study is expected in the second half of 2021. PanDIA-1 is a study focused on the third risk group, that is the new onset diabetes type 2 at the age of 50 or over. It is a Swedish study with collection at three hospitals in Sweden. We have more than 6,000 samples collected so far. We expect an interim analysis in the second half of 2021. We're very excited about these studies as they represent individuals and patients from the three target groups we are aiming for. With that, I would like to move to the next page 13. We have discussed in the past the size of the market. I just want to reiterate that the potential of the IMMray PanCan-d test is substantial. We estimate that the total addressable market, when all three risk groups are addressed, is over $4 billion. This is only for the U.S. and European markets. We will continue to analyze the total world market over time as we progress. Next page 14. Now, a few words on our pipeline of discovery projects. Next slide 15. Whilst our main focus is on the launch of IMMray PanCan-d for early detection of pancreatic cancer, we continue to 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 cohorts. As you know, collection of samples has been affected by COVID-19 in 2020. As these are discovery studies, meaning they are in the early stage of our R&D model, it is not my intention to give timelines on these two discovery studies. We will report data when we have new data and information to share with you on these important discovery projects. Next slide, please. Slide 16. Briefly, a few words on the financials 2020. Next slide 17. Our income in 2020 was SEK 360,000. This is some minor royalty income that we have. Operating earnings were a minus SEK 134 million in 2020. This should be compared to 2019, where we had an operating earnings of minus SEK 114 million. More importantly, cash or cash equivalents at the end of the period was SEK 468 million. The direct share issue brought in SEK 400 million in June 2020, as I stated earlier. Thus, we have a run rate over 3.5 years based on our last year cash burn. We are, however, communicating in our 2020 year report a run rate of over two years based on our planned ramp-up of commercial and development activities at Immunovia in the next years to come. If you now turn to the next page 18, which is a summary slide, and then turn again to the next page 19. In conclusion, when we launch IMMray PanCan-d this quarter one in 2021, we introduce the first test based on serum samples for the early detection of stage 1 and 2 pancreatic cancer. This is a major achievement for Immunovia as a company, and it's of course, a major achievement and will affect patients, not the least. We will be the first to market in a very large market opportunity. We are fully on track for the launch in Q1. We have the samples in-house. We are ready. The final step is conducting and reporting the blind validation study. Furthermore, we are well-funded. We have the means for a full commercial rollout. Of course, we continue to stay committed and focused to obtain a 30% market penetration long-term with IMMray PanCan-d. Next page 20. Before we go to the question- and- answer sessions, I would just want to remind everyone that we have posted a series of new tutorials on our homepage. The Immunovia team has been extremely busy lately, as you will see. Hopefully, you will find these tutorials informative. Thank you very much, everyone. With that, we will go to the next page, and we will open up the call for question and answers. Thank you. If you wish to ask an audio question, please press zero one on your telephone keypad. If you wish to withdraw your question, please do so by pressing zero two to cancel. Once again, if you wish to ask an audio question, please press zero one on your telephone keypad. There'll be a brief pause while we wait for questions to be registered. Our first question comes from Viktor Sundberg from ABG. Please go ahead. Yeah. Good afternoon, and thank you for taking my questions. First, you mentioned before that there is a waiting list of individuals that are interested in the IMMray PanCan-d test. Can you give any more details with regards to this list and give any guidance if you should expect a bonus effect when it gets CLIA accredited in quarter two? Also, on the topic of sales guidance, you talked in the report about your goal of 30% penetration in the long term. Do you still also reiterate the SEK 250 million-SEK 300 million sales-based sales targets for next year? Reason why I'm asking is, of course, that timelines have shifted a bit since you set that target back in 2018, 2019. Thank you. With regards to the individuals, I should call them, who have registered with us with their interest in being tested, that list exists. We have a database of that. We will contact these individuals now again to reassure and to update their interest. They will, of course, be a target group in the beginning. It's a group of individuals in the mid few thousands. With regards to this year's sales target, I've been in this industry for 35 years. I've been engaged in launching a number of diagnostic tests. It's always extremely difficult in the first year to predict the sales outcome. I think from my point of view, what we will be looking for is really getting the right traction. The trajectory is more important than the absolute number of tests that we will be able to book, so to speak, in 2021. It's really about the trajectory, the acceptance from the key opinion leaders. It is being there to hopefully already in the first year enable identification of an early stage 1 or 2 PDAC patient that has out-of-pocket enrolled in our program. Those are the types of things we will be looking for much more so than a dollars and cents target. Another question on the accreditation process as well. Your medical director, I think, alluded to the last webinar that the CAP accreditation might come later than CLIA accreditation. Do you still reiterate that timeline of CAP accreditation in quarter two, or when would that be finalized and perhaps what steps are left in that process? Also, of course, specific states in the U.S. also have their own accreditation standards. I was wondering if you could give any guidance on the process with specific states, and how we should think about the sales ramp up with regards to both the fact that the CAP might come later and that states could be a bit slower on accrediting your lab. I'm guessing just trying to understand the sales curve here as we talked about in the previous question. Sure, absolutely. From our point of view, obviously the most important CLIA license is the New England and the Massachusetts CLIA license. That we expect to routinely that would be 30 days to obtain that license. That's pretty straightforward. You are right that there are some states like New York State where obtaining a CLIA license is a little bit more time-consuming. That will come later for practical reasons. With a Massachusetts CLIA license, we will be able to cover the majority of the states and be active broadly in the U.S. CAP is something where in our thinking right now sort of a six months post CLIA license is a reasonable time point. It's not critical right now to obtain that. Right now I think we think that there's sort of a 6 months timeline for that would be suitable. Okay. A final question here on self-pay. I wonder if you could give an update as well on the European launch or the CE mark process, I guess. When do you expect that to be finished, and when can we expect that you will begin recording sales in Europe? Right now we are 120% focused on the U.S. launch, and we will be regrouping so to speak post-launch to look at the timelines for a European rollout. We will be communicating that later. It's premature for me to comment on that on this call. Okay. Yep. Just a final question here also on the PanFAM study and the path forward with reimbursement. First, do you think the full results will be available in 2022 as previously communicated? Can you just highlight the road maybe to reimbursement for screening test specifically? Wouldn't that require also a congressional decision or a Grade A or B recommendation from USPSTF in order for Medicare to go ahead with the coverage if that would be local or national? I guess local as you said here in the presentation. It will definitely be local. As you are aware, we are going not for a general screening approach. We are not proposing general population screening, and therefore we don't see a reason for choosing any other route than the route that I described. That's how we see the situation, and we think that path is actually very straightforward and well understood not only by us but largely by the community in the U.S. Okay. Thank you very much. Thank you. Thank you. Our next question comes from the line of Alex Cogut of Kempen. Please go ahead. Sure. Hi, Patrik. Thanks for taking my question. Thank you for providing kind of a reimbursement plan for the U.S., but could you also give us a bit of a timeline for all of these steps? I have a couple more questions. Okay. Hi, Alex. I think with regards to the process and the steps that we need to take, I think I've been very clear today. In terms of what to expect from a timing point of view, in my experience we should be able to obtain a PLA code I would say within the first six months of the first PanFAM results. To get to the actual coverage agreement with the payers, that can vary a bit, and we will get a better and a much firmer idea of that when we get the feedback from the second payer study to understand exactly what the payers are expecting the dossier to consist of. It's a little bit premature. In my experience, that side of it can also go fairly quickly. We do need to get the more specific and updated feedback from the payers to be very specific on that and to get back to you. Sure. I appreciate that. Of course, with the PanFAM results, you mean the full results, not the interim analysis? Yep. Yeah. For the interim analysis, which is now reiterated guidance to come in H2, maybe just for PanFAM since that was a press release you released a couple of days ago, what kind of analysis are you actually performing? What data will you be reporting? Most interestingly for us is that this is a cohort that's been put together based on exactly the type of customers that we will be approaching. It will provide us a very large database of samples where we directly can compare and contrast samples with a familiar and hereditary background. They are healthy. They have no symptoms. They're perfectly healthy, but they do have the genetic traits. We can compare and contrast that with individuals from the familiar and hereditary group with early PDAC stage 1 and 2. It's extremely valuable for us in that sense to get that sort of compare and contrast with a cohort that is in every sense of the word comparable to the target groups, obviously. Yeah. The interim is basically just you're kind of comparing next to standard of care, and then the next step is observational, where basically routing patients based on Immunovia's test only. Is that correct? Yeah. That's correct. Alex, I do want to correct myself a little bit to say that in my opinion, and this is my opinion, and it's based on my discussions with experts in the field, I do think that even with the interim readout from PanFAM study in the fall, depending on, again, feedback from the payers, from the study that we do with the payer study, there is a possibility that we could be approaching also and asking for a PLA code just based on that. It is something that we will need to investigate further. Got it. Yeah. Thank you. That's it from me. Thank you, Alex. Thank you. Just as a quick reminder, if you wish to ask an audio question, please press the zero one on your telephone keypad. Our next question comes from Caroline Banér from DNB. Please go ahead. Hi, Patrik. Thank you for taking my questions. Another question on the PanFAM study. I believe you previously communicated that you planned on recruiting 2,000 subjects and recently communicated that you ended recruitment by end of October last year of 1,265 subjects. I was just wondering if you could share some details on why it's not 2,000 subjects. Yeah. Basically, some of that has to do, again, with COVID-19, unfortunately, that not all new patients were interested in enrolling in the study. That is sort of the main deviation, actually. All right. Will there be any deviations in the PanSym and PanDIA-1 as well? The PanSym, we already have 2,000, and of course, as I think we have indicated, the PanSym collection from UCL in London was in fact also affected by COVID-19. As you know, the U.K. had a very, and still continues to have a very heavy COVID-19 impact. Yes, it is somewhat impacted, yes. Okay. All right. Thank you, Patrik. Thank you. Our next question comes from Jack Lynch from Not Given. Apologies, Jack's company's not been provided. Jack, please go ahead. Thank you very much. Yes, a private investor. Patrik, congratulations on getting the blood samples and for being on target for the end of Q1 with the validation and the commercialization very shortly after that of this incredible technology. The question is really linked to America and the share price. If this stock was in America right now, I think it would be worth 10, 20, possibly even 30 times its current market valuation here in Europe. As this is very much America-oriented, particularly now, when are you going to go for an American listing, use American research houses, and also start using American financial institutions? Yeah. Hi, Jack. I think basically we also think that the U.S. financial market is very interesting. There's obviously a number of peers in the U.S. to whom we compare, and from that point of view, would be a very interesting market. I do think that it's a bit premature for us to discuss publicly our sort of long-term plans for our future in terms of intentions in the U.S. I think at this stage, we are a Swedish-listed company. We are launching the product in the U.S. We think the U.S. market also in many senses, the commercial market is extremely exciting for us. I myself have worked and lived in the U.S. for almost 10 years. In many regards, the U.S. is obviously extremely interesting. I think at this stage it's a bit premature to start discussing sort of long-term ambitions with regards to a dual listing or something like that in the U.S. Definitely an interesting thought. Thank you. Thank you. Our next question comes from Felicia Rittemar from Vator Securities. Please go ahead. Hi, Patrik. When you went through the reimbursement plan, could you please allude a bit on the studies to demonstrate health performance and clinical utility once you have already launched? Do you expect any, and what is your plan regarding these? Yes. We definitely expect to do further studies in the U.S. The major one will actually be PanFAM as the first one, I think. I think that will be very much guiding with regards to what the next steps are. It's clear that for some of the application areas or risk groups, we will need further studies, and this needs to be run by American key opinion leaders. They need to be run locally in the U.S., and they also specifically need to have a focus based on the dossier feedback under dossier requirements that we get. We have already three studies that we are discussing with key opinion leaders that would be run, and these will not be that long studies, but will be fairly targeted studies. Okay. Thank you so much. Thank you. Thank you. There appears to be no further questions, so I'll hand back to the speakers for any further remarks. Thank you very much to all of you for your participation and for your interest in Immunovia. As I said, I'm extremely excited to be here at Immunovia as the new CEO. We are on the brink of commercial launch on our first test in the U.S., and I'm extremely proud of the entire Immunovia team and the hard work that they have performed, not only in 2020 but throughout the years to take us to this stage where we're ready to launch. Thank you very much, everyone, and thank you for your interest. Thank you
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