Ladies and gentlemen, welcome to the Immunovia Q1 Interim Report 2024 Conference Call. I am George, the Chorus 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 Karin Almqvist, CFO. Please go ahead. Thank you so much, and I'd like to say good morning and good afternoon to all of you, and welcome to our conference call following our first quarter results 2024. Presenting here on the call is Jeff Borcherding, who is our CEO, and myself, Karin Almqvist, I'm the CFO of the company. As you already heard, the presentation will be followed by a Q&A session. Our operator has and will continue to guide us on how to pose questions, and like last time, you will also be able to give your questions via the chat function. After we have closed the call today, you will find the presentation and the recording on our website. And with that, I'd like to hand over to Jeff, please. Thank you, Karin, and thanks to all of you for joining us today. I'm excited to share the information that we have with you, and our theme today is delivering on our promises. In July last year, we announced a number of significant changes to Immunovia. At the time, we made a number of promises about the transformation of the company that was needed in order to survive in the short term and to thrive in the long term. We promised to develop a better test. We promised to transition to a better testing platform to increase accuracy and lower costs. We promised to transform the company to lower our expenses and to increase our speed to market. I realize that these changes, especially the removal of our IMMray PanCan-d test, were frustrating for most of our investors. I appreciate your patience, and I'm very pleased to report that we are delivering on the promises that we made several months ago, and plan to continue to work hard to deliver on our commitments. During today's call, we'll review results from our next generation test. Excuse me. We will also discuss the lab and product platform changes that we're making. We'll talk about the milestones progress that we've made, as well as the milestones that lay ahead. We'll review our first quarter financials and our cash position, and then we will open things up for questions from you. I am incredibly excited to share the news about our next generation test. We recently completed the model development study that we've been speaking about, and we delivered strong performance in that study. We met both the primary and the secondary endpoints. We achieved the target accuracy, the sensitivity and the specificity that we were aiming for. We showed that our test is statistically superior to CA19-9, and the new test offers multiple advantages over IMMray PanCan-d that we'll talk about today. Stepping back a bit, in November, we announced the results of the largest study ever in looking at proteins and their ability to distinguish pancreatic cancer from those who do not have cancer. These are the results from that study. We identified 15 promising biomarkers that could, in a statistically significant way, separate pancreatic cancer samples from those of control samples. Following those results, we took those protein biomarkers and really went to work developing commercial assays that could be used to measure them in an accurate and in a reliable way, time after time. Through that work, we took 10 markers into the model development study, and I'm excited to share the results with you today. A little bit about the design of our model development study. Our objective was to use this study to develop a high-performance test of pancreatic cancer biomarkers using the markers that were discovered in the discovery study. This is a retrospective study, meaning that we used cases that we had collected previously of blood samples from multiple pancreatic cancer centers in both the U.S. and in Europe. A case-control study essentially means that the lab runs the test, runs the assays, and we determine whether those assays are able to accurately distinguish between the pancreatic cancer blood samples and the blood samples from individuals who do not have pancreatic cancer. While this is done in a retrospective way, we also were able to blind the study. So the people at Immunovia knew whether these samples were pancreatic cancer or not. But the study was done with our partners in Proteomedix. And so at their lab in Switzerland, that team didn't know whether they were testing a pancreatic cancer sample or a control sample. Our primary endpoint was to look at the sensitivity and the specificity of the test. Sensitivity essentially means if cancer is there, do you find it? And specificity means, do you avoid the problem of a false positive, essentially a positive test result, when in fact, the cancer is not there. We really need both of those two things in order to have a successful test. And then our secondary endpoint for the study was, is the test performing better and more accurately than CA19-9? CA19-9 is a biomarker that is commonly used to detect pancreatic cancer, but it's sort of recognized that it has limitations, and so as a result of that, it's not broadly used. So there's clearly an opportunity, as we've discussed previously, to build a test that is more accurate, that can take the place of CA19-9 in detecting pancreatic cancer early. In the study, we looked at 133 blood samples from patients who had pancreatic cancer. One thing I want to point out is that these are patients that had stage 1 and stage 2 pancreatic cancer. Sometimes you will see tests perform studies in all stages of pancreatic cancer, so stage 1 through 4. The problem with that is that if you're not detecting the disease at stage 1 and 2, you really can't impact, in a positive way, the survival of that patient. A patient's likelihood to live five years with pancreatic cancer is more than 10x higher if, in fact, they've been diagnosed at stage one or two. And so those are the samples that we focused on in this test. We compared those pancreatic cancer samples to control samples. These are people who are at risk for pancreatic cancer but don't actually have it. So these are people with family history or genetic mutations that put them at risk. Some of them have cysts in their pancreas that are not cancerous. Others were diabetics, and then we also included healthy controls. One of the things I think is really important when you look at the results of our study is the fact that we had a wide range of control patients. We did not take the easy route and just include healthy individuals. When you do that, it's easier to show good test performance, but the risk is that you may not have a test that is as robust as what you can get when you do the model development, when you build the test using a wide range of patients. And so that's why we did it this way, and we're very pleased with the results. This is a bit of a technical slide, but it looks at the 10 biomarkers that we took into the model development study and shows that many of them performed individually, very effectively. So the columns that are labeled P values, if you see a P value that is less than 0.05, that essentially means that that biomarker, that protein, was able to tell the difference between pancreatic cancer samples and control samples. As a result, you can see several of these, the biomarkers that performed very well in the discovery study, also performed very well in our model development study. And those are the ones that we use to put together in various combinations to look at different test models. So what were the results that we got? You can see here that our next generation test exceeded the performance targets that we had set. The specificity of the test was 98%. Remember, that means that we're very unlikely to produce a false positive report. That's critical in this market. You can imagine, because pancreatic cancer is so deadly, we really want to make sure that we're not incorrectly telling someone they have pancreatic cancer if they don't, because then that puts them through quite a difficult journey as they go through the true diagnosis process with imaging. Even though they find out they don't have pancreatic cancer, we want to avoid that. So that 98% specificity is really high and very positive. The sensitivity at 75% is also very good. That means that we're finding three out of four cancers with a simple blood test, a simple blood test that's so much easier to use than the imaging approaches that are often used today to detect pancreatic cancer. And then finally, you can see that we were statistically superior to the performance of CA19-9. That P value of 0.003 means that there's very little doubt that this test performed better than CA19-9. In addition to the strong performance overall, we really were pleased to see the performance of the test and think about how that compares to IMMray PanCan-d. Even though we didn't include IMMray PanCan-d in this study, we know that this test is performing better in at least three key ways. The first is that it includes more accurate protein biomarkers. Both the old test and the new test include CA19-9, but the key is that the new test includes more accurate biomarkers in addition to CA19-9, so that the test isn't fully reliant on CA19-9, as IMMray PanCan-d was. The second big advantage of the new test is that it provides a clear, positive or negative result. There's no borderline or gray zone category. With IMMray PanCan-d, about 10% of patients got a borderline result, and what we found in the market was that this created confusion for clinicians, and it created concern and uncertainty for patients. We wanted to eliminate that with the next test. The fact that we were able to get such good accuracy results, even though we were only designating people as either positive or negative, really shows the power of the new test. And then finally, the new test performs well in a wider range of patients. I mentioned that when we conducted this study, we didn't just include healthy individuals or just include individuals at risk for hereditary or familial pancreatic cancer. We really believe there's an opportunity to serve a wide range of patients, and we're excited to do additional studies to really look into that and make sure that we can, in fact, serve a wider range of patients, whether that be differences in race and ethnicity or differences in the underlying health of that patient. Last July, we talked about the fact that we needed to move away from the proprietary IMMray platform that had been so central to the company's history and was foundational technology for Immunovia. It was a difficult decision, but we knew there was an opportunity to use a better platform that would provide a number of benefits. That platform is called an ELISA platform, and as you can see here, we, as we've made that transition, we're seeing a number of benefits. The first, and maybe the most important, is that ELISA measures the proteins more accurately than IMMray. As we do multiple measurements, we get very, very consistent results from one measurement to the next. The second advantage is that the ELISA assays can be performed more quickly. As a result of that, we will be able to produce reports within a day or two at most, after we receive the sample from a patient. That turnaround time is especially important in this market. Once people get tested, they have a lot of anxiety about whether that test is going to be positive. Do they have pancreatic cancer? So if we can provide a result as quickly as possible, that will be a source of great satisfaction for our patients. Stopping the use of the IMMray platform also drastically reduced our fixed costs. We had a number of employees in Lund, Sweden, who were producing materials and supplies that were needed for us to run the IMMray PanCan-d test. Since we've moved to an ELISA test, we don't have to do all of that production, that manufacturing within the company. We can simply purchase what we need, when we need it and avoid those fixed costs. And then finally, also, from a cost perspective, our cost per test will be lower, we expect, with these ELISA assays, once we get into the market and start to ramp up our commercial volume. You may have seen the news earlier today, we were excited to announce that we have hired a new lab director and will be opening a new lab in North Carolina. That lab will take the place of our lab in Marlborough, Massachusetts, which is just outside Boston. This is part of our broader effort to streamline our operations and to lower our costs. The new lab is much, much smaller than our prior lab and office, and as a result of that, our costs will be lower going forward. In addition, Research Triangle Park in North Carolina is a lower-cost city than being outside of Boston. What that means is that we can hire employees at a lower cost than what we were able to do in the Boston area. Our first employee in the market is Lisa Ford, a Ph.D. in bioorganic chemistry, who has really, really deep experience. She has developed multiple lab-developed tests in the past, taking them all the way from the beginning of the process when they were just an idea, and taking them all the way through to the clinical lab. She is board certified, and one of the things I'm very excited about is that we've already seen her make tremendous contributions to the company. Even though she's just starting as an employee, she was a consultant to us for the last couple months as part of the model development study. During that time, I found Lisa to be incredibly smart, very curious. She is very disciplined. She has a great understanding of how to implement good processes, and she's also very practical, which is critical for a company the size of Immunovia. Part of making sure that we deliver on our commitments is making sure that we deliver on the committed timing. I'm excited to share the fact that as we have moved from the research phase and into the development phase of our new test, we are very much on track with the timelines that we laid out. We went through the proposal stage, where we defined what we wanted the product to look like. We then conducted the discovery study and identified those 15 proteins that we talked about earlier. We are wrapping up the definition stage as we complete the model development study, and then we're looking forward to the analytical validation and clinical validation stages. Lisa, our new lab director, will lead the charge for the analytical validation stage. She'll be doing a number of experiments to make sure that we can accurately measure the individual proteins in the test, to make sure that the results are consistent over time and under different conditions. And she'll look at a lot of other technical factors related to running these tests. After that, we'll move into a clinical validation stage, and essentially, that will be another case-control study, similar to the one that we did here with the model development study, but on a larger scale, to make sure that we can accurately separate pancreatic cancer samples and identify those from the samples that do not have pancreatic cancer, those control samples. From there, we'll move towards a commercial launch in 2025. Thinking about the commercial phase is incredibly exciting. As we think about that, we are targeting a launch sometime midyear in 2025. As we think about commercialization, our goal, as we've discussed previously, is to partner with a larger diagnostics company that already has commercial capabilities. This will allow us to market the test more effectively, get market penetration faster, and importantly, really lower our costs, because we won't have to build an entire sales force and entire commercial organization on our own. We will have certain key resources that will complement the resources of our partner, but it will allow us to be choiceful in making those investments. One of the other things that will happen as we begin 2025 is we will undertake multiple additional clinical studies. Clinical studies are the key to getting reimbursement from payers in the U.S., whether that is government payers or private insurers who cover many Americans and pay for their healthcare. We know from our experience with IMMray PanCan-d that one test, excuse me, one study is not enough. We need multiple clinical studies showing the effectiveness of the test in different populations and under different conditions. We're very excited about our pipeline of studies. We have been doing a lot of work with key opinion leaders and experts in the field to design and think about the types of studies that we want to do. We'll be announcing those studies over the next several months as we get ready to kick them off in early 2025. With that, I'll hand it over to Karin to talk through our financial position and Q1 results. Thank you. Continuing on the aspect of being able to deliver on time, we are pleased to be able to conclude that also financially, Immunovia has been delivering on plan. There are two main aspects when you want to monitoring Immunovia from a financial, there are two main aspects to take into consideration. It's OpEx and it's cash burn. When it comes to OpEx, if we compare the Q1 performance relative to the Q1 performance last year, we've been able to reduce our OpEx by approximately the half. This has been a result of the restructuring program that we initiated last year, that already in Q4, but more so now in Q1, has shown results. We see that our headcount cost has dramatically decreased. At the same time, we also see that there are some shifts when it comes to OpEx. We are spending heavily, and we have a heavy focus on, on R&D, now in 2024. Our average cash burn for the quarter was SEK 8.7 million per month. Total for the quarter was SEK 26 million, which is substantially down compared to last year, where we had a cash burn of SEK 38 million. We can move to next. So if I was to summarize, the financial results for Q1, we have cash and cash runway as our focus, along with, with our OpEx development, and of course, they are interrelated. Our cash balance for the quarter was SEK 61 million. We're expecting to be able to stay just shy of SEK 10 million in cash burn per month throughout the year, and that will then take us into Q4, having sufficient cash, but it will not make us be able to close the fourth quarter, and it will not take us into 2025. We need to seek new financing for that. Focus for us, 2024, is to continue to hold a firm grip around our spendings, thereby having a tight cash management. So in order for us to be able to have a full focus, just to be able to strategically secure the future and secure funding for Immunovia. And with that, back to you, Jeff. Thanks, Karin. So in closing, we are delivering on our promises to develop a better test, to transform the company. We promised to develop a test that was better than IMMray PanCan-d, and we now have a high-performance, next-generation test that showed strong results in the model development study and outperformed CA19-9. We promised to transition from a proprietary IMMray platform to a more efficient, more accurate, lower cost ELISA platform, and we've delivered on that commitment. We promised to dramatically lower costs and become a leaner, faster, less expensive company. We've delivered on that commitment. We've reduced staff by 80% and have increased our productivity. It's always difficult to make these commitments. We know that there are challenges in the market, but the reality is that we are committed to delivering on the commitments that we make to you, our shareholders. I realize it's been difficult to be an investor in Immunovia. I also realize that we continue to face challenges as we develop and bring our next-generation test to market, most importantly, a challenging financing environment. But still, we are committed to launching a great test, and we're committed to doing that in a way that unlocks shareholder value and that rewards our investors. We appreciate your support and look forward to continuing to deliver on our promises. And with that, I'd like to open things up for any questions that you might have. We will now begin the question and answer session. Anyone who wishes to ask a question 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 a question. Anyone who has a question may press star and one at this time. Once again, to ask a question, you may press star and one. Ladies and gentlemen, we have no registrations for questions over the phone. Any questions through the chat, Karin? I can pull them up as well. I think we may have some questions on the chat. Yes. It looks like the first question is, oh, here it is. Okay. When will you need to raise money? This, this may have come in before, Karin's slide. We have sufficient cash, as Karin noted, to meet our needs through the third quarter of 2024. We do not have sufficient cash to take us into 2025, and so we are actively focused on ways to fund the company. Related to that, there was another question as I look through the list here: How do you plan to raise money? We've been pursuing a variety of different options. We do expect to announce our approach soon. We recognize that it's important to raise money relatively soon, given our cash runway, and so we hope to announce the approach that we'll take relatively soon here. One of the other questions was: Is the new test dependent on CA19-9, like the IMMray PanCan-d test was? So the next-generation test includes CA19-9, but is less dependent on CA19-9. With IMMray PanCan-d, CA19-9 was really the driver and was a critical component. We could not produce results without CA19-9. With the new biomarkers in the next-generation test, we are continuing to analyze the results in low CA19-9 patients, and we will be continuing to look at that, but we really feel good about the strength of the biomarkers aside from CA19-9 that are in the next generation test. So we are excited to move forward with the new test. There's a question: When will you start generating revenue from the next generation test? And that is difficult to know. As I mentioned, we will plan to submit applications for reimbursement from commercial and government payers in the U.S. in late 2025 or early 2026. It's difficult to predict after that when we will get approval for coverage and start to get reimbursed for the test. But we do feel good that we're gonna have a very strong package of clinical data that can support the use of the test. How can we trust Immunovia when we've been disappointed so many times in the past? I think this is a really fair question to ask, and I guess I would point to two things. First, the management team and the organization are a different group of people from those who led the company in the past and who you may have been disappointed in. This is a new team in many regards. We have really made it a commitment to take some of the really top performers from Immunovia historically and combine those with some new hires who meet critical needs. The second thing that I'd say beyond the team is that I'd ask you to judge us by our performance over the last few quarters. You know, I'm proud of the fact that we have consistently achieved the commitments that we made to shareholders when I became the CEO in late April. As we talked, we've made great progress on the next generation product. We've reduced staffing. At the same time, we've been able to strengthen the team. We've reduced our expenses and cut our cash burn, and we continue to be focused on delivering on those promises. I realize, though, that we have to earn your trust, and we continue to work to do that. Additional question here. Again, this might have come in after the last one. Can you elaborate on the plan for funding from Q4? I wish I could give you specifics today. We are not quite ready to announce our capital plans, but again, we expect to do that soon. And I don't see any additional questions. We'll give it just a minute, and then, if there are no other questions. I think we can conclude the call at that point. I really appreciate your support. Thank you for joining us today. Hopefully, you learned a couple new things and come away from this call as excited as we are about what's ahead for Immunovia and our next generation test. Thanks again, and have a great day. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.