Ladies and gentlemen, welcome to the Immunovia Press Conference Call. I am George, the call's call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Jeff Borcherding, CEO. Please go ahead, sir. Thank you very much, good afternoon, everyone. Yesterday, we announced a major plan to restructure our operations to focus on our promising next-generation test for the detection of pancreatic cancer. I am excited about the test we have in development and wanted to share additional information about this decision and our path forward. As we discussed on the first quarter earnings call, there's three major challenges. The first is demanding payer requirements for robust clinical data. This clinical data is key to securing reimbursement from U.S. payers and generating revenue. The second challenge is proving clinical utility in pancreas cancer. These studies must be large, and they often have to take place over a longer period of time if they are prospective studies. The third challenge that we face is the risk-averse financial market and limited access to capital that comes along with that. In response to these three challenges, we undertook a process, in conjunction with our board of directors, to evaluate our options. There were really two key parts of the assessment. The first key part of the assessment was looking at our ability to generate data, showing better patient outcomes with the use of our early detection test. That's the key to securing payer reimbursement. The second part of our planning process that I'll talk about in a moment, was focused on our financial situation and the financial realities we face. Starting with how we generate the patient outcomes data that would enable us to secure reimbursement. As we thought about that issue, we thought about a couple challenges. One of those challenges is related to our product, IMMray PanCan-d. Our test is partially reliant on CA19-9. This is one of the nine biomarkers in our test. Unfortunately, CA19-9 is not produced by about 10% of people. As a result, for those people, we cannot produce an IMMray PanCan-d result. The inability to produce CA19-9, unfortunately, disproportionately impacts minorities, including those of African ancestry and Hispanic ethnicity. In addition to thinking about the IMMray product and its ability to deliver results, we thought about some of those clinical study challenges. We know that prospective studies require a very large number of patients followed for multiple years. We don't have the resources to conduct such a study on our own. We need to partner with existing studies that have funding from other sources. Because these studies are broader and are often supported by multiple sponsors, we know that these studies are likely to incorporate different arms for different assays, including other commercial assays and CA19-9 alone. We have to be confident, if we're going to participate in these studies, that our test could succeed in comparison to others. As we thought about generating the clinical data, we also thought about our opportunities. The next-generation test that we have in development is one that we've been working on since last year. Our next-generation test for early detection of pancreas cancer incorporates new biomarkers, it's specifically designed to work equally well across different risk groups. In addition, it's expected to provide accurate results in patients who don't produce CA19-9 and to reduce our overall reliance on CA19-9 in the test. Doing that would make our test equally useful for patients of different ancestries and ethnicities, that's really critical. We have a moral and an ethical obligation to serve patients equally and to help eliminate some of the healthcare disparities that have led to higher rates of mortality in pancreatic cancer for these minorities. As I mentioned on our last conference call, one other opportunity that we have in the clinical study arena is doing retrospective studies. We have identified investigators who have access to both clinical samples of serum, as well as clinical information about those patients that could allow us to do retrospective studies, which would save time and obviously, quite a bit of money compared to the larger prospective studies. That was the assessment that we went through as we looked at both our product challenges and our clinical study challenges, and then the opportunity that we have with the next-generation test. I mentioned that the second part of our planning process really looked at our financial situation. Capital markets at this point, continue to be risk averse. That's true across the Nordics, in the U.S., and in Europe. In addition, our lower market capitalization means that any equity raise would result in substantial further dilution, and clearly, we've already experienced quite a bit of that with the rights issue that we completed. During the last conference call, I talked about our burn rate and our cash reserves. I mentioned at the end of Q1 that we were running at the low end of our historical burn rate of about SEK 15 million-SEK 20 million per month, but it's frankly still too high. We also, at that time, had cash to fund us through the first quarter of 2024, which, if we don't make changes, would continue to be the runway. It's simply not enough runway in the current financial environment. As we think about different cost-cutting moves, those cost-cutting moves that we had made previously reduced our run rate, but not quite sufficiently, not enough for what we needed. As part of our financial analysis, we also had a number of conversations with investment bankers and with prospective investors. Those conversations confirmed and reinforced the financial challenges that we had seen from our perspective. After looking at all of these factors, the board and I came to a number of conclusions. We cannot sell and market the current test, IMMray PanCan-d, and at the same time adequately support the next-generation test. We need a sharper focus. The next-generation test gives us the best opportunity to deliver the clinical study results that are needed to secure reimbursement. To adequately fund the R&D efforts, our clinical efforts for that next-generation test, we made the difficult decision to remove the IMMray PanCan-d test from the market. Doing that will meaningfully lower our run rate. I mentioned in the press release yesterday that we expect significant staffing reductions. Those reductions will occur both in the U.S. and in Sweden across a range of functions, including our sales team, customer service, and operations. We will retain key personnel that are critical for the work on our next-generation assay, both from an R&D standpoint, a clinical study standpoint, as well as the preparation work to market and sell that test when it is ready in 2024. We'll also be looking at our operating expenses. Now that we will not have a test in market, we will be able to reduce those expenses as well, and we'll be working on doing that in the next coming weeks. These moves will allow us to extend our cash runway further into 2024. We'll share a more detailed plan when we report our second quarter results. At this point, it would be preliminary to say exactly what the reduction in our burn rate and the extension of our cash runway will be. We should have more clarity when we report those results in August. In summary, I'm really excited about the potential of our next-generation test. It gives us an excellent opportunity to demonstrate clinical utility that's needed to secure reimbursement from U.S. payers and to generate revenue. We've taken dramatic but necessary steps to focus our resources on the next-generation test. These steps will bolster our financial health, and they provide flexibility in a tough market environment. I want you to know that I remain committed to our mission of saving lives through the early detection of pancreatic cancer, and I also remain committed to doing all that we can to reward you, our shareholders, for your investment in the company. I truly appreciate it, and I'll do everything I can to provide the rewards that you're hoping for. With that, I'll say thank you and open it up for any questions that you might have. We will now begin the question and answer session. Anyone who wishes to ask a question or make a comment may press star and one on their touch-tone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking questions. Anyone who has a question may press star and one at this time. The first question comes from the line of Michael Löfman from FTC. Please go ahead. Thank you, Jeff, for this run-through of the alternatives. I was just wondering, could you expand a little bit about the choice of assay going forward and why it wouldn't be necessary to have your own labs going forward if you choose a more standardized assay or standardized machine? Thanks. Yes. Yes, as we mentioned in the press release yesterday, the new assay that we bring to market will be on a commercially available platform rather than the IMMray platform. This will allow us to scale production much more quickly. It'll also allow us to produce the test at a lower cost of goods sold, so provide substantial benefit, from both of those perspectives. As a reminder, anyone who has a question, may press star and one. There are no more questions at this time. Excuse me, we have a follow up question from the line of Michael Löfman. Please go ahead. Hi. Just a follow up. If you look at what's available in terms of machines out in the lab, it's mostly ELISA and Luminex. Can you expand a little bit about the different differences between these two? Sure. We are actually looking at both of those platforms. There are advantages and disadvantages of both. Factors to consider as we think about going forward will be the number of biomarkers that are included in the platform, the cost of running the test on the different platforms. At times, for example, Luminex may be more cost effective if we have more biomarkers, whereas an ELISA platform might be more cost effective for smaller biomarkers. The choice there is very, very much tied to the assay itself and will reflect the best clinical decision, but also the best financial decision about the right platform. Thank you. Thanks. There are no further questions. Excuse me. We have a last minute question from Hans Stefan, from GDC. Please go ahead. Hi. Could you elaborate on the studies required for how it gets approved by the authorities, please? Yes. In order to secure approval for the test, it will depend on which pathway we choose. In the U.S., you can pursue approval from FDA, or you can pursue what's called CLIA accreditation, which essentially is a shorter and faster way to get to market. That's what we did with the IMMray PanCan-d test. I'll focus there. In that case, really what you have to show is analytical validity, which means that your test measures what you say that it measures. That's what's really required in order to get approval. There are other studies that are required in order to get coverage from payers and actually get reimbursed. The analytical validity is the first step. It's a relatively straightforward step. The more extensive and more complicated step is showing clinical utility. That means that the use of your test actually improves patient outcomes. Those studies are either very long and prospective, and large studies. We will likely do one of those studies in conjunction with another group, potentially two studies. Importantly, we have an opportunity to do retrospective studies where we will use existing samples and show that the test has clinical utility relative to the current standard of care. Thank you. Thank you for the question. For any further questions, please press star and one. There are no more questions at this time. Well, I thank you for your time. I appreciate your patience with us, and certainly look forward to future conversations where we will share more information about the changes that we've made today, the impact of those changes, and over time, sharing more information about the next generation assay that we expect to launch in 2024. Thanks again for your time. Ladies and gentlemen, the conference is now over. Thank you for choosing Conference Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.