Immunovia AB

of data from that study, what we were looking at was the patients in that study who had familial or hereditary high risk, meaning they have family history of pancreatic cancer or they have genetic mutations that but that's within this group. Why did we look at this group? Well, essentially what we wanted to know was within that group that has family history or hereditary risk, that also has signs and symptoms of the disease, what kind of accuracy did we see? That's really important because by law, Medicare in the United States, which is the insurance company for people over the age of 65, they cannot provide reimbursement for pure screening tests. High risk individuals who are undergoing screening must have signs and symptoms to be eligible for reimbursement. So what we did in this analysis was we looked at those people who were at high risk, but they also had signs and symptoms of disease. So that could be things like pancreatic cysts, diabetes, chronic pancreatitis, lesions in the pancreas, or other abnormalities that are seen on imaging. When you look at the data in this group, what you see is results that are consistent with and even a little bit better than what we see overall. So the sensitivity of the test is 83.3%, meaning that pancreasure detected more than four out of five stage one and two pancreatic cancer cases. We also had very good specificity from the pancreas sure test in this study at just under 92%. These data give us really good data to submit for coverage as we pursue Medicare coverage and a local coverage determination. In addition to the analysis that we just looked at, We do have other studies that are going on currently or that will be coming to conclusion soon. The DECIDE study is a survey of experts in the field where we essentially give them scenarios and ask them, how would a pancreas sure test result impact their surveillance of a high-risk patient? We expect to complete that in August in terms of the data collection and then be in a position to share results in the fourth quarter. In addition to that physician survey, we also recently conducted a survey among high-risk individuals, so a patient survey. Our goal there was to understand what the interest level in a blood test is and how high-risk individuals would want to use the blood test. So we're working through the data analysis of this now and plan to announce results later this month. The Assure study is our observational registry study that we are conducting in conjunction with Northwestern, which is the lead investigating site. And then also we hope to bring you on about 15 additional study sites over the next year who will participate in this study. We're currently working on finalizing study agreements with several investigators and sites. And so we're excited to have that program off and running. And then finally, we have an interesting study where we'll be looking at pre-diagnostic samples. Essentially what this means is looking at blood samples that were collected before the patient was actually diagnosed with pancreatic cancer. In some cases, it could be six months before. In other cases, it could be as much as two or three years prior to their diagnosis. We're conducting this study with Kaiser Permanente, one of the largest health systems in the United States, and we're hoping to analyze the samples in the third quarter and then announce results in the fourth quarter. All of these studies will be very helpful, not only as we think about our Medicare submission, but also future submissions to secure commercial coverage as well. And then finally, just transitioning to business development and some of the opportunities there, we're really focused in four areas. The most important for us strategically is to partner with a large US diagnostics company that can help us really realize the full commercial potential of the pancreas share test. We're looking for a company that has a large existing sales force and has a presence in the market that will allow us to really drive trial and adoption of the test in a very different way than what we can do currently with a very targeted three-person sales team. In addition to that collaboration, we're also exploring potential collaborations with multi-cancer early detection tests So these are blood tests that are looking for multiple cancers, anywhere from six or seven cancers up to 50 cancers, depending on the test. What we've seen from the results of these multi-cancer tests is that while they are able to detect pancreatic cancer in the later stages of disease, they have very poor detection and sensitivity of early stage pancreatic cancer, which as you saw we have very, very strong results for pancreasure. So there may be an opportunity to partner with one or more of these companies. In addition to what we're doing in the US, we're also looking to partner in Asia to bring the pancreasure test to the Asian market. Our initial focus is on Japan and China, and we have a number of promising discussions that are going on there. And then finally, You may have seen some recent news about progress in developing new drugs for pancreatic cancer. There is more promise in the drug market for pancreatic cancer than what we have seen in decades. And as these companies are developing and launching these new therapies for pancreatic cancer, we believe there's a great opportunity for us to partner with those pharmaceutical companies to increase the number of people that are getting diagnosed, and also to increase the percentage of people who are getting diagnosed early, who are getting diagnosed at stage one and two. Both of those will support the success of drug launches in this space because of the fact that if those drugs can be used earlier in the process, what we're hearing from the pharmaceutical companies is they're much more confident in the ultimate outcome for the patient with that early stage diagnosis and treatment. So we are very excited about what's happening on the business development front. I wish I could share more. As you can imagine, these are very confidential discussions. And so we have to be pretty limited in what we say, but that's where things are. And we hope to be able to share updates in the second half of the year. And with that, we'd like to hear what questions you have for us.

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Okay, we have several questions in the chat. The first one, you plan to submit for Medicare coverage in Q3. What specific data will be included in the submission? And what is the expected timeline from submission to a coverage decision? And are there precedents for blood-based oncology diagnostics that give you confidence on the timing? So if you think about our package for submission, there are multiple components, but I think you can summarize it into three categories. of clinical data about pancreature. And then in addition to that, we want to submit data that outlines the clinical need. So the data on the clinical need will come from published literature. We will also be submitting data that we collected historically as part of our PANFAM study to establish the clinical need for high-risk surveillance particularly in this subset of patients that have signs and symptoms of disease. That data from PanFam is actually going to be very helpful for us as part of our submission. Then you have the three categories of data about pancreasure. The first is analytical validation. Essentially, they're looking for data that shows that we accurately measure the biomarkers that are part of our tests. We have published literature on that, a large manuscript that we've published. And so we will be submitting that manuscript. The second component is clinical validation. Essentially that means from a clinical standpoint, how accurate is the test? That's really the specificity and sensitivity data that we talk a lot about. We now have three published clinical validation studies that we will be submitting And in addition to that, we will be submitting a manuscript based on the data specifically in the Medicare population that I just shared. So that manuscript will also be part of our submission as well. And then finally, clinical utility is the third piece of data about the pancreas share test that we'll submit. Clinical utility essentially relates to two things. Number one, Does your test help physicians make different and better decisions? And number two, does that lead to better outcomes for patients? So the clinical studies that we just talked about will be helpful in this regard. So the DECIDE survey really gets at that question of how does the information in a pancreasure test guide the physician's decisions? And we will have that data and we will include it in our submission. We also have data that we will be including in the submission over time from other clinical studies like the registry, where we'll use that to show data around the effectiveness of early detection. I also mentioned the Kaiser pre-diagnostic studies that we will be doing. One thing that I should point out about the submission is that Our plan is to submit in Q3. One of the dynamics for these submissions is that you are able to submit data after your initial submission. Everything doesn't have to be included with that initial submission. So we plan to submit in Q3, and then we will augment or add to our submission over time. Moving to the question of the timeline from submission to a coverage decision. Unfortunately, there is not a hard and fast, reliable timeline that I can give you. The timelines can vary quite a bit from one product to another, and there are a couple factors that go into that decision. One is the quality of the submission. Second is, what is the clinical need for the test that's being evaluated? And we think that's a real opportunity for us because of the fact that pancreatic cancer is so deadly. Knowing that there's such a significant clinical need here, one of the critical things for us is to make sure that we communicate that to the Moldex group that evaluates tests like ours and hopefully convince them that that means we need a priority review that gets done more quickly than something that is maybe less important or has less of an impact on the Medicare population. Continuing on the Medicare topic, we wrote last year that Medicare coverage is in the symptomatic high-risk population. The question is how that affects the size of the primary target. And previously, we had talked about 600 high-risk individuals as a relevant group. Two things I would say there. Number one, since we shared that estimate of 600,000, the market has expanded in a pretty meaningful way. As associations have changed the guidelines on who should be tested, the number of high-risk individuals eligible for surveillance has increased substantially. So we see that number generally as much higher. And then thinking about the fact that we do need those individuals for Medicare to have signs or symptoms, what does that mean in terms of what we can expect? Well, what I would say is about 35% of these individuals have pancreatic cysts, so that group would automatically be included. In addition, what we know is that in the U.S., if you look at the elderly population, about 20 to 30% of individuals over the age of 65 have diabetes. And so that's going to give us just between those two a very large percentage of the market. And then on top of that, you have some of the other things around pancreatic abnormalities, chronic pancreatitis, et cetera. So we feel like the market will be very substantial and we'd be able to capture the majority of the high-risk individuals. In Q1, we talked about a sales pipeline of 71 engaged prospective centers. And the question is, how's the pipeline evolved in Q2? I would say we now have more than 110 centers that are engaged and in various stages of the pipeline. And as we think about the conversion of those centers from prospects to active ordering centers, What we see currently is that it varies quite a bit from one center to the next. And so one of the things that we're going to be focused on in the second half of the year is really looking at what are the attributes and characteristics of the groups that move through the process that I laid out earlier very quickly and what characterizes the groups that move through slowly. And so what can we do differently? So that'll be something we'll focus on for the second half of the year. I think this probably came in before we talked about it, but just to clarify, we do plan to apply for Medicare in Q3. So we had communicated that previously, and that is still our plan. Another question was, when do we anticipate receiving approval from New York? Again, we don't have a hard and fast timeline, but I am optimistic that we will receive approval in the third quarter. When we received the round of questions from New York, their questions were very straightforward, things that we could provide data for quickly, and so we are optimistic about a Q3 approval from New York. A question here about will high risk asymptomatic patients have to be covered by private insurance? So private insurers don't have that same requirement that the patient has signs and symptoms. So if you've got patients that just have the familial hereditary risk, they will be covered by private insurance. Is it possible to comment if there are any discussions in an advanced stage, i.e. term sheets or exclusivity discussions I would prefer not to comment on that at this point and just be in a position where we can announce something when we have something that's concrete. So I'll defer answering on that for now. And I think, just let me check, I think that is all the questions that we have received. Yes, it looks so. Well, I think that concludes then our Q&A session. Please reach out to me or Adam if you have additional questions following today's session. We really appreciate you joining us and we're excited to be transitioning to the next phase of the pancreas share launch as we continue to drive test use in those high-risk surveillance programs but we start to focus a little bit more on driving volume and more on expanding the number of targets that we are covering in order to continue to drive the growth of the test. We look forward to submitting for Medicare coverage in Q3 and progressing with the studies that we've outlined here, as well as continuing those discussions in business development and certainly hope to have good news to announce in the second half of 2026. So thank you very much for your time. We appreciate it and look forward to speaking with you in the future. Goodbye.