Immunovia AB (publ) (IMMNOV) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the Immunovia Q2 Interim Report 2026 Conference Call. I'm Lorenzo, the Chorus Call operator. [Operator Instructions]. The conference is being recorded. 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, and thank you to all of you for joining us today for the review of Immunovia's second quarter of 2026. As we will share, we have achieved important milestones in the commercialization of PancreaSure, and we are transitioning to the second phase of the PancreaSure test launch. We're also excited about the progress that we continue to make in the pursuit of Medicare coverage, and we'll share updates on our efforts there. I'm also pleased with our business development progress as we have ongoing conversations with potential partners. As you can imagine, I won't be able to share a lot about the specifics of those opportunities, but wanted you to know that we are focused on business development and are pursuing a number of paths there. So for today's call, we will focus initially on the commercial uptake and traction of the PancreaSure test. We'll also talk a little bit about some of the drivers of growth in the second half of the year. My colleague, Adam, will cover our Q2 financial results and our cash position. And then I will come back to discuss clinical studies that are in progress and our reimbursement efforts as well as those business development opportunities that I mentioned. As always, we are excited to hear your questions and would very much like to have a robust question-and-answer session at the end of the presentation. Before I share more about the Q2 results, I thought it would be helpful to go back about a year to when we were approaching the launch of the PancreaSure test and laid out the commercial strategy. At that time, we talked about four key elements of our strategy. First was that we would start at the top. We would focus initially on top key opinion leaders, focus on the leading high-risk surveillance programs across the United States. Our goal there was to drive advocacy and PancreaSure test use within that expert group so that we could rely on their advocacy as we broaden the scope of the PancreaSure launch. The second thing that we recognized is that when you launch a lab-developed test like PancreaSure, initially, revenue is very limited. The reason for that is that we don't have reimbursement in place. We knew that it would take time to get reimbursement in place. And as a result of that, one of the things that we are doing is making sure that we tie our investment to the stage that we are in, meaning at the early stages, we want to limit our investment. We want to closely manage our expenses so that we can make sure that we extend our runway as long as possible during that time when we don't have strong revenue coming in. Our goal there is to strike a balance. We want to make sure that we invest enough that we show the commercial potential of PancreaSure, but at the same time, we want to limit our costs. Partnerships are going to be crucial for us. That will be both as we think about launching the test in the U.S. and bringing on a commercial partner to help us expand our commercial reach. We were also looking at partnerships outside of the U.S., and so we'll talk about that. And then finally, from the beginning, we have been very focused on how do we build an efficient, scalable business where we execute with discipline. And so all of these things were elements that were in place when we launched the test in September of 2025. And you can see here the three phases that we have talked about previously. We're currently transitioning from the targeted advocacy phase and into the volume building phase, the second phase of the launch. From a targeting standpoint up to now, we've been very, very focused on those high-risk surveillance programs for pancreatic cancer that exist at top academic centers and also in the large health systems across the country. Our goal during this phase has been to drive trial with those top experts, and we are succeeding, as you'll see on the next slide. Certainly, even though we are transitioning to the next phase, I do want to emphasize that our work with high-risk surveillance programs is really just beginning. We have a robust pipeline of additional centers that we're actively moving through the sales process, and we expect that to continue not only throughout 2026, but throughout 2027 as well. At the same time, we now want to shift to putting more energy and attention on building volume and specifically building volume within those high-risk surveillance programs that have started using the test, but maybe they're still in the early stages of that adoption. That volume will largely drive, or the volume that we generate will largely be driven by our existing customers. But during this next phase, the volume building phase, we will also begin selling to targeted gastroenterology groups. Most importantly, we're targeting very large GI groups. Many of these groups span multiple states. And our goal there is to be able to partner with large GI groups that are interested in implementing the PancreaSure test across their network of gastroenterology practices. As of the end of the second quarter, we now have 27 high-risk surveillance programs that have used the PancreaSure test since launch. And I am incredibly proud of the team at Immunovia and our strategic account managers who have driven such good initial use within these top surveillance programs. You can see here just a sampling of the programs that have used the test since our launch in September. These names may or may not be familiar to you, but they are many of the top academic centers and health systems in the United States. In fact, if you look at national rankings of the top 20 cancer centers across the United States, 10 of those top 20 cancer centers have ordered the PancreaSure test. An example of that is Memorial Sloan Kettering, which is ranked the #2 oncology hospital in the U.S. Memorial Sloan Kettering began using the PancreaSure test in the second quarter. So they are very early in their use of the test, but we were excited to bring them on board for commercial use of the test, and we're also talking about ways that we can partner with them on research. As you think about our sales process, I wanted to give you a little bit of insight into how we think about moving prospects from the pipeline into our customer base. And then once they become customers, how do we drive volume through a disciplined sales process to full adoption. You can see here the five stages that we track prospects through, once they reach a stage where it really seems as if they are interested in using the test. We move them through a registration process where they register to use our online portal and then they begin using the test in the trial phase. During that trial phase, what we often see is that there's very good enthusiasm for using the PancreaSure test. Our challenge as a company is to make sure that we translate that excitement into a steady stream of PancreaSure tests. And there are some challenges with that. One of the challenges is that these systems have, in many cases, protocols that exist. They have processes that they're using currently to manage high-risk surveillance patients. And so we need to work with them to modify those protocols to adjust their processes and to get them to be thinking about PancreaSure in a very different way than when they're just at that trial phase. We want to move them through early adoption where they have ordered more than 10 tests, and then we consider full adoption when a site has ordered not only 10 tests in one quarter, but they're doing it quarter after quarter. And we have several sites that are now in that full adoption stage. One example would be UCLA Health, which I spoke about on a previous call when they had just begun using the PancreaSure test. We've now worked through various logistics challenges and operational challenges with UCLA, and they are ordering on a regular basis when they run their high-risk clinic. As we think about the second half of the year and this focus on growing volume, we see several catalysts. The most important driver of growth will be our strategic account managers. Those three sales reps that are spread throughout the country that are developing relationships with these centers and driving adoption of the test. I mentioned on a previous call that we have launched a registry study. Essentially, this is a way to show how PancreaSure is used in the real world in clinical practice. What we're seeing in conversations with high-risk surveillance programs is that they are very interested in this registry program. It's very helpful for them because it allows them to combine two key priorities for those hospitals. One priority is enhancing their patient care. The other priority is generating research. Nearly all of our customers are academic medical centers or health systems that are very interested in generating research. So they want to be part of this registry study. And we think that's going to give us an opportunity both to engage new prospects, but also to drive volume among those centers that have already started using the test. Then a final driver for 2026 as we move into the second half of the year is new clinical data. One of the realities of being a sales rep in healthcare, particularly in the U.S., is that you have to compete for the attention of the physicians who are your customers. One of the ways that you can do that is by bringing them new data, new information that they haven't seen before. The fact that we have an upcoming pipeline of that kind of information is very helpful for our strategic account managers so that they can get access to physicians, have meaningful conversations with them about the benefits of PancreaSure and also, as we said earlier, work with them on any logistics issues that are getting in the way of adopting PancreaSure. One other note that I should make about potential catalysts in the second half. We are still waiting for a response from New York State and hope to receive that in the third quarter. They followed up with us a while back to ask for some additional information, which we provided, and we continue to be very optimistic that we will receive coverage in New York. When we do that, that will open up a number of opportunities for us in that state, which is one of the two largest states in the country. With that, I'll hand it over to Adam to talk through our Q2 financial results and cash position.

Thank you, Jeff. So as Jeff said, we're now turning into our financial performance for the second quarter, but also for the first six months of 2026. So, we start with the sales. Our net sales increased to SEK 381,000 in the second quarter comparing to SEK 90,000 same period last year, which represents an increase by over 300%. For the first six months of 2026, net sales increased to SEK 755,000 comparing to SEK 229,000 last year. The operating loss amounted to SEK 22.9 million in the second quarter comparing to SEK 20.9 million in the same period last year. For the first six months of 2026, our operating loss was SEK 41.3 million comparing to SEK 38.9 million in the same period 2025. We have, in the second quarter, increased number of strategic account managers, as Jeff said before, which has increased the personnel costs from the first quarter this year and as well comparing to the same period last year. We have accelerated our clinical studies during the second quarter, which also has increased our other OpEx in the second quarter comparing to the first quarter this year. We are still lower than expected cost for the full year of 2026. The net loss for the second quarter amounted to SEK 22.8 million comparing to SEK 41.1 million last year. And this corresponds to earnings per share before dilution of the negative SEK 0.03 comparing to SEK 0.14 last year. We can move on to the next slide. Thank you, Jeff. Our average cash burn during this quarter was SEK 7 million per month, which are very similar to the previous quarters, which was well below our previous guidance of SEK 8 million to SEK 10 million per month for the full year. The lower cost burn is primarily due to our lower spending on clinical studies during this period for the first six months this year. At the end of this quarter, our cash position was SEK 34.9 million. Based on our current plans and spending levels, we expect our existing cash position to fund operations into the fourth quarter of 2026. This includes funding for the clinical studies and intends to support the future reimbursements. We are, as you understand, actively evaluate a range of different financial alternatives, including equity financing, strategic partnerships and other sources of capital with the object of extending the company's cash runway until the second end of 2027. I will leave over to you now, Jeff.

Thanks, Adam. Transitioning then to reimbursement and our efforts to secure coverage and the clinical studies that support that. This is a slide that I shared last quarter that talks about the fact that there are three ways to secure payment for PancreaSure. Ultimately, our goal is to achieve reimbursement in the third path here, insurance payments after we have received medical coverage decisions from these payers. Essentially, that means that the payers have decided that the test is medically necessary and appropriate for high-risk patients, and therefore, they will consistently reimburse it at the full rate that we have agreed to. To get there, we know that we have to go through the medical policy process to secure coverage. That takes time, as I laid out earlier. And so how do we generate revenue before that? Well, there are really two paths. The first is securing payments directly from patients. The second is securing payments from commercial or private insurers even before we have coverage. Unlike Medicare, which will not pay for any test before coverage decisions are in place, many private companies will consider paying for a test like PancreaSure. There is a long process. It often requires many steps and quite a bit of time to secure payments from commercial insurance companies before coverage, but we are starting to see some early signs of positive results there. We started submitting to insurers in February of 2026. You would think that we would have more information at this point. However, the reality is that because of the length of time that it takes these insurers to process those claims, we still have only limited information about whether they will reimburse us for the test and at what price they will reimburse us. So we know that it won't be the SEK 995 that we bill. The question is what percentage will we receive. And we will get more information about that in the back half of 2026. As we've mentioned previously, a key focus for us is submitting for Medicare coverage. We are on track to submit it in the third quarter. And during the second quarter, we released the data that you see here. This is a pooled analysis of data from the CLARITI and VERIFI clinical validation studies. And in this pooled analysis 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 put them at high risk. We took that subset of individuals who were included in the CLARITI and the VERIFI studies. We pulled them together, and then we looked at the test performance 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 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 the PancreaSure detected more than four out of five Stage 1 and 2 pancreatic cancer cases. We also had very good specificity from the PancreaSure 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 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 PancreaSure 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 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. 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 U.S. diagnostics company that can help us really realize the full commercial potential of the PancreaSure 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 6 or 7 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 U.S., 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 1 and 2. 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.

[Operator Instructions] There are no questions from the phone at this time.

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 time line from submission to a coverage decision? And are there precedents for blood-based oncology diagnostics that give you confidence on the timing? So as 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 PancreaSure. 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 test. We have published literature on that, a large manuscript that we 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 PancreaSure 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 of 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 MolDX 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. 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 has 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. As you 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 will 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. I think, just let me check, I think that is all the questions that we have received. 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 PancreaSure 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.