Immunovia AB

Ladies and gentlemen, welcome to the Immunovia Q1 Interim Report 2026 conference call. I'm Lorenzo, 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 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Peter Hongard. Please go ahead.

Thank you. Yeah, my name is, as introduced, Peter Hongard. I am the chairman of the board. And if you could forward to the first slide, please. It's a pleasure for me to participate in this webcast today, which we're going to do a little bit differently. The difference is that we're going to provide you with somewhat more forward-looking statements and give you an idea about the interesting and exciting milestones which Immunovia is going to meet over the next year or so towards being a full-fledged commercial company. And in order to incentivize this, we have also put an incentivizing scheme in place both for management but also for the board itself. And I'll come back to that a little later in the presentation. But first, handing over to Jeff to explain more details about the company today and the plans going forward. Jeff, please.

Thanks very much for the introduction, Peter, and great to have you on the call today. I'd like to start by talking about our plan for 2026 and really what extends beyond that as well. As we do that, I'll cover key results from the first quarter as we think about our focus areas for this year and how we're achieving our goals and objectives for those areas. We've defined three clear focus areas to grow the business this year and to create shareholder value. Not surprisingly, the first focus area is commercial, the launch, sale of the pancreas sure test in the United States to the high risk surveillance centers and other physicians that are conducting high risk surveillance for pancreatic cancer. We'll talk about partnerships and business development, why we think those partnerships are important, what's happening today and what you can expect going forward. And then finally, as we look to maximize revenue from the test, it's really important over time that we build the coverage for the test and secure full reimbursement from Medicare as well as from private commercial payers. So I'll talk about our plans for reimbursement, including the clinical studies that are already underway and those that are coming in order to continue to bolster the case that we make that pancreasure is medically necessary and should be covered by these payers. We've spoken previously about the PANC Reassure commercial strategy, but now that we are a few quarters into the launch, actually I guess just now in the third quarter following the launch, it's important to talk about what our goals are and what our strategy is. Remember that we have launched the test initially in a very targeted way. We are starting at the top. We want to build advocacy among top key opinion leaders at those large leading centers for pancreatic cancer surveillance. It's really important that we tie our investment to the revenue that we're generating. We don't want to make an enormous investment in commercialization early on in the launch of Pancreasure. We want to time our investment and increase our investment as we start to get closer to the period where revenue will ramp up so that we don't burn too much cash along the way. We'll talk about the importance of a commercialization partner. And as we think about positioning ourselves to be attractive to a partner, demonstrating commercial traction and showing that we're building towards reimbursement and revenue is especially crucial. And then finally, we want to be very efficient. We want to run lean. And I think you'll hear in Adam's comments about our Q1 financial results that we are achieving just that. We're launching the test in three phases. We're currently in the targeted advocacy phase, that early phase where we are focusing very clearly on top high-risk surveillance programs across the United States. We essentially will be in this targeted advocacy phase for the next quarter, As we move into the back half of the year, we'll move into more of a volume-building phase, and we'll start to expand a little bit our target audience before we move into the revenue growth stage in 2027. When we first launched Pancreasure, you might remember that the launch was initially led by members of the management team. I'm happy to share that this quarter, first quarter of 2026, we hired an excellent team of three strategic account managers who, under the leadership of Sarah Giedemar, our VP of sales and marketing, have come on incredibly quickly and have started to make a real impact in just a matter of weeks. As we think about this first phase targeted advocacy, the metrics are very much aligned with the goals of this phase. So our key metric is how many high-risk surveillance centers have come on board and begun ordering pancreature. That's the most important metric. Obviously, we also want to make sure that those centers are ordering as many tests as possible. So, the number of orders per center is also an important metric. That metric will become more and more important as we move into the volume building phase starting in the back half of 2026. I am thrilled to share that we now have 21 leading pancreatic cancer centers who have ordered pancreas sure tests through the end of the first quarter. You see the names on this slide, and my guess is that some of them may be familiar, some may not be. But Beth Israel Deaconess Medical Center is affiliated with Harvard University. You can see that we have other top academic institutions like Penn Medicine and Northwestern Medicine. In addition, we also have leading health systems that are not academic centers, but they see a very large number of patients in certain geographic areas. Systems like Hackensack Meridian and Honor Health, as well as Prisma Health, which have all become excellent customers and users of the Pancreasure test. This obviously isn't the full list of 21, but I think it gives you a sense of the geographic breadth of what we're looking at. We have centers across the country. And again, we have both academic and private health systems who are using the pancreas share test. Probably the best measure of the initial impact of those three new strategic account managers under Sarah's leadership has been the increase in the sales pipeline that we saw. Two of those reps were hired in mid-January. One was hired in mid-February. And yet you can see that from the end of December 2025 through the end of March, we've had a dramatic increase in the sales pipeline. So, again, 32 prospects in that pipeline up to 71, a 145% increase. So tremendous progress in a short period of time. And we look forward to those strategic account managers continuing to make an impact. As we think about the remainder of 2026 and into 2027, it's helpful to talk about what are some of the key programs that we see that are going to drive pancreas sure testing volume as we start to move into the back half of the year where, again, more of our focus will be on volume of testing, not just the number of centers that are using pancreas sure. First, we need to continue to drive trial. Our three strategic account managers have really built the pipeline, as you saw on the prior slide, and we will capitalize on approvals in California and New York State in order to drive additional trial. As we think about the centers that have come on board, one of the key challenges is to move beyond a situation where those centers are using the test occasionally or they're trying the test and getting them to a place where pancreas sure is truly incorporated into their protocol. They are using it on a regular weekly basis at a fairly high volume. And to do that, we will focus on uncovering what gets in the way We also want to make sure that we engage the full clinical staff, not just that key opinion leader who leads the overall program, but the full team that can help make Pancreasure an important part of how they conduct surveillance for pancreatic cancer. We've also put ourselves in a position where we can identify best practices at these centers across the country, and we can share those with other centers. We see a number of things that certain centers do very well that helps drive not only the success of their program, but also leads to greater use of the pancreas share test. So we'll be developing case studies and sharing best practices across our customer base to really help them succeed and also help us drive volumes. And then finally, as we move further into 2026, we will start to move beyond just these high-risk surveillance programs. Our next group of targets will be large gastroenterology groups. These are private practices of what usually includes several dozen patients. gastroenterologists across multiple offices, sometimes across multiple states across the U.S. And we will be looking to develop commercial and research collaborations by piloting programs with these large GI practice groups. More to come on that later in the year as we start to roll out those programs. So as we think about the commercialization of the Pancreasure test, we've shared previously the fact that our initial focus will be very targeted and we will use our own internal resources to drive the success of Pancreasure. Over time, though, to really capitalize on the opportunity that we have with Pancreasure, we want to bring in a commercialization partner. that commercial partner can significantly increase our commercial reach. They can increase the impact. They can also bring expertise to the table that we don't have currently within pancreas share. I'm excited by the fact that we are now regularly speaking with over a dozen potential commercialization partners in the U.S. These are primarily large diagnostics companies. that have extensive sales teams that could be in a position to sell the Pancreasure test when the time is right. We're talking with them about multiple different ways to collaborate. Certainly, our primary focus is on partnering with a group that has a large sales team that could co-promote the Pancreasure test. But we're also talking with them about our research projects and seeking funding from them for those projects. We hope that one or more of these partners may become an investor in Aminovia. We're looking at joint marketing programs as well as other programs at this point. One of the questions that I receive fairly regularly from investors is, when is the right time to partner? And I think it's important to realize that from our perspective, we want to partner at a time when we have strength in the negotiation, where we have clear momentum, where And so we want to make progress towards reimbursement, and we want to demonstrate commercial traction for the pancreas sure test among the leading experts in the field. One of the things that we also realize is that partners have their own timelines based on their development programs, their strategies. And so our goal is really to find the right partner at the right time on the right terms. We won't rush this. We will make an agreement when it makes sense for the company and when we can optimize the value for shareholders by having such a partnership. Switching now to talk a little bit about reimbursement and clinical studies. One of the things that I think, in fairness, I probably haven't communicated effectively enough in the past is the fact that there are actually multiple ways to obtain payment for the pancreas sure test that we do. And you can see here those three different ways we can obtain payment. First is obtaining payment from patients directly as part of a cash pay program. Second, we can bill insurance companies directly. prior to having coverage decisions in place in the hope that they will reimburse us for the test, even though they haven't yet made a formal decision to cover the pancreas sure test as part of their medical policy. And then obviously our longer term goal is to make sure that we get those insurance payments following a coverage decision. after that payer has said that they consider the Pancreasure test medically necessary and reasonable. And that's when we will see certainly some additional benefits from a revenue perspective. Let's talk a little bit about each of these and sort of how things play out over time. So when we first launched Pancreasure in September 2025, we were doing the payments from patients. We started billing insurance companies this quarter in February of 2026. And then as we've shared previously, we will be submitting for Medicare coverage in mid 2026. I would expect that will likely be in the third quarter of this year. We are working to secure not only Medicare coverage, we will also be working with commercial payers in an effort to pursue coverage from those commercial payers as well. As you can imagine, there are a large number of those payers across the United States. They have different timelines for review. They're looking at different factors. So that work will take time, but we are already beginning to have the plans in place, and we will work through those conversations later in 2026 and certainly on into 2027. If you think about the revenue or the amount that we can bill per test and then the revenue that we expect to receive, when we bill patients, One of the key things that it's important to keep in mind is that we do offer financial assistance. And so some patients don't pay anything for the pancreasure test. That generous financial assistance program is really important to help us get momentum behind the use of the pancreasure test. So cash payments can be anywhere from $0 or $100 up to $750. When we bill insurance companies prior to having coverage, we will bill them the full amount of the TAS 995, but it's not clear yet what amount we will receive. One of the things about these submissions to insurance companies is that it takes a long time for them to process those claims. Oftentimes, the initial claims will be rejected immediately. we will have to appeal those rejections in an effort to get paid. So the time to collect is much longer for those payments. Then if you think about what happens in 2027 and beyond when we hope to have full insurance coverage in place, the Medicare test that we do or the test that we do for Medicare patients, those that are covered by the government program for U.S. citizens over the age of 65, we will receive the $897 price that we talked about previously. And from a private payer standpoint, we would also certainly expect to collect more per test once we actually have coverage in place. In addition, the other advantage is that we would collect that revenue more quickly once we have coverage in place because there are fewer steps. The process is streamlined when you have a coverage decision that says the payer has agreed that they should be covering the test. As we think about what does it take to get that coverage decision, to get to that stage that we talked about on the right side of the prior slide, we really need clinical data across three key areas, analytical validation, clinical validation, and clinical utility. As we've shared previously, we have excellent data that has been developed and published in peer-reviewed publications that describing our analytical validity and our clinical validity, and we are now working on clinical utility. Clinical utility essentially means does the patient benefit from the test, and is the test impacting what clinicians do following the conducting of a pancreas share test? This is information that we have not shared previously in total form. This is the list of studies that we are doing now that are near term and are intended to support our initial submissions to payers in 2026. So, this information is going to be collected through surveys of both physicians and patients. as well as the registry study that we announced earlier this week called Assure. One thing I want to clarify about the Assure study is that while the study will run through 2029, we expect to be able to generate interim data from that study well before that, at least on an annual basis, and likely even more quickly than that, we will be able to generate data from that Assure study. Finally, I want to highlight the final study on this slide. because I think it's an important step in demonstrating the true value of a pancreasure. One of the things that we have the opportunity to do is show that pancreasure can detect pancreatic cancer even before it is found on imaging. So, we are working with the largest health system in the United States, Kaiser Permanente, to test pancreasure on samples that they have from patients who later developed pancreatic cancer. These are blood samples that happen to be collected from people who, at some point, six months, a year, or even three years later, developed pancreatic cancer. And these samples will give us a sense of how early Pancreature can detect pancreatic cancer. In addition to these retrospective studies and surveys, we're also going to be conducting more controlled prospective clinical trials. Two of these at the top we've talked about previously. These are studies looking at pancreatic cysts where we're conducting studies with the National Institutes of Health. The National Institutes of Health or the NIH essentially is covering nearly all the cost of these two studies where we're looking at whether the pancreas sure test can help clinicians make better decisions about the surveillance of people who have cysts and make better decisions about what patients should go to surgery because of concerning cysts that look like they might be pancreatic cancer. At the bottom of the slide, you can see the two studies that we're conducting or that we are about to launch. These are, again, going to be with a large health system in the United States, and these are prospective studies designed to help us continue to characterize the sensitivity and the specificity of pancreature in prospective patients. controlled clinical studies. So, the work that we've done to date has been retrospective studies where we use previously collected samples. In these studies, we will be doing a prospective view that will allow us to give the information to clinicians in real time, give them an opportunity to act on the results of the test, which will be really important in further demonstrating that clinical utility how the test can impact the clinician decisions, and how those changed decisions lead to better outcomes for patients. You can see that some of these tests will, or some of these studies will take a couple years to complete. But again, all of this is about building significant evidence, not only to support payer submissions over time, but also to guide clinicians in their use of the pancreas share test. We haven't previously talked about one of the opportunities that we have been pursuing behind the scenes, and I'm excited to share this today, and that's really talking about how we can expand our market through the use of artificial intelligence. So, The reality is that today, if you look at most people who get diagnosed with pancreatic cancer, it's what's called sporadic pancreatic cancer, meaning that that person didn't have known risk factors before they got the disease. As a result of that, most patients diagnosed with pancreatic cancer in the United States would not have met eligibility criteria for screening. They were never screened. That leads to the problem that we see where people get diagnosed too late, and when they're diagnosed too late, their options are limited and their survival rate is very poor. So what we need is an approach that goes beyond the standard risk factors that we often talk about, beyond family history, beyond genetic mutations, beyond pancreatic cysts, so that we can identify those who are at high risk even though they don't fit into one of those existing categories. I'm excited to share that there are exciting developments in this space with multiple centers developing AI-based models where essentially they analyze data from electronic health records of hundreds of thousands or sometimes even millions of patients to identify different factors that collectively might increase the risk of that patient getting pancreatic cancer over the next few years. So, it could be things like a history of chronic pancreatitis. It could be their age. Perhaps it was someone who was a smoker in the past. There are lab values that are collected routinely during patient care. things like A1C or hemoglobin that can help understand what a patient's risk is. On the left-hand side here, you see one of these models called the PRIME model from New York University. And you can see what factors they have looked at to say these factors indicate that a person could develop pancreatic cancer over the next three years and should be tested. These models are able to develop people who are to identify people who are at high risk. So, in that NYU model, the people who are in the top 1% of their model in terms of risk have nearly an eight-fold risk of developing pancreatic cancer over the next few years compared to the average person in those studies. that increase in risk at eight times the normal level is similar to, and in some cases even higher, than the genetic factors or the family history that we look at today to identify risk. What does this mean for the business? Well, it means there's a tremendous opportunity here. We've talked previously about the fact that in the United States, there are about 600,000 high-risk individuals that we would consider to be excellent targets based on their family history or genetic mutations. That translates into a total addressable market of about $540 million, or almost 5 billion sick. When you look at the market for AI-identified high-risk individuals, what you can see is it's nearly three times as large. The market is 1.7 million high-risk individuals, and the size of the market is $1.5 billion or $13.8 billion SEC based on an assumption of $900 in value per person. So, This creates a tremendous increase in the business opportunity for us, and we're excited to capitalize on that opportunity. And this is what it would look like in a given clinic. Biomarkers like Pancreasure will be used once a health system goes through and identifies those individuals who are at high risk. So I mentioned the prime model at NYU. That would identify the 1% of individuals at the highest risk of getting pancreatic cancer. All of those individuals would be tested with the Pancreasure test. From there, those that test positive with Pancreasure would then go on to have imaging studies, most likely an endoscopic ultrasound, to get a definitive diagnosis of pancreatic cancer. We are already moving forward with this effort. We have one pilot study that is underway with Northwell Health, which is the largest private health system in the state of New York. They are conducting a feasibility pilot to look at their own AI model and how it can be implemented in their patients. They have 3 million patients in the Northwell system, and we're supporting that effort. We also have two other studies that we will be announcing shortly where we will be using the Pancreasure test as part of a pilot for the use of these ai models where they're identifying high-risk individuals they'll then be using the pancreas sure test to conduct the the flow chart that we saw earlier to identify of those who are at high risk who actually has pancreatic cancer One of these is with a leading health system in New York. The other is with one of the largest health systems in the United States. And that study is one that's being conducted in conjunction with the Pancreatic Cancer Action Network, which is the leading advocacy group in this space. Hopefully that gives you a good sense of where we are in 2026 and what comes beyond. At this point, I'd like to turn it over to Adam to talk through our first quarter financial results and our cash position.