Immunovia AB (publ)

Thank you very much. This is Jeff Borchening, CEO of Immunovia. I'm very excited that you've chosen to join us today and want to thank those who have taken the time to learn more about Immunovia and our exciting progress over the first quarter. As we continue on our journey of saving lives through early detection of pancreatic cancer, This first quarter marked an important turning point for the company as we transitioned from product development and a focus on the product and clinical development and transitioned to a focus on commercialization and preparing to launch our test later on this year. Before we jump into the presentation, I'd like to share a brief story It's about a woman who reached out to me a few weeks ago. She is a young woman in her 40s. She has a family and also has a family history of pancreatic cancer. She lost her mother to pancreatic cancer at a fairly young age. As you can imagine, this has caused quite a bit of anxiety for her as well as for her family. She's also a person who knows quite a bit about this space. She is a physician researcher at a major institution in the United States. And as she has looked at the current state of the approach for surveillance, she has decided that she's not interested in things like endoscopic ultrasound or an MRI each year because of some of the downsides of using those imaging approaches to monitor for pancreatic cancer. She reached out because she saw the recent clinical data that we had published following the completion of our VERIFY study. She was very excited about the results and wanted to know when the tests will be available. I share her story because it's just one example of how anticipation and excitement is building for the Pancreasure test as we approach launch. On today's call, we'll talk a little bit about those clinical study results and how those results can support reimbursement. We'll also discuss our launch preparations, how we're progressing, and what will come next as we get ready to launch the test in September of this year. We'll also talk very briefly about strategic partner discussions and then discuss our Q1 2025 financials before moving to questions and answers. To start, I'd like to share those results that got that mother, that individual, that high-risk person so excited about the Immunovia test. This is from a study called VERIFY that included nearly 400 blood samples from top pancreatic cancer centers that you see here on the right. You may recognize some of these names as groups that we've worked with before, but some are also new as well. In this study, we looked at individuals who provided blood who had early-stage pancreatic cancer, so 115 blood samples from individuals with stage 1 and 2 pancreatic cancer, and we compared those to 271 high-risk controls. For those of you familiar with our CLARITY study, this is essentially a very similar design to what we did in that study This study was a little bit different in that those 271 high-risk controls not only included those who are at high risk for family history or for genetic mutations, but in this study, the VERIFY study, we also included people who are at high risk for pancreatic cancer because they have a pancreatic cyst. that's a fluid-like sac on the pancreas that in many cases turns out to be benign and doesn't cause any problems. But about 15% of those patients go on to develop pancreatic cancer. And it presents a real clinical challenge for physicians in this space. So we were excited to include some of those high-risk individuals in the control group. And we also had a number of individuals who had pancreatic cysts that became cancerous in our cases group. As we announced previously, the results of this study were very similar to what we saw in the CLARITY study. We had very strong sensitivity again, meaning that 77% of the time, so more than three out of four patients with stage one or two pancreatic cancer were detected using the Pancreatic Share Test. At the same time, in this very challenging group, which we know is more difficult to distinguish cancer from controls because of those cis patients, we still showed high specificity at 88%, meaning that we would have a low rate of false positive results. As you think about those numbers, I think it's important to put them into context. I mentioned some of these imaging approaches as I was sharing the story about the high-risk individual who said, I really don't want to pursue those types of imaging approaches. You can see here on the slide the sensitivity and specificity that we typically see from those imaging approaches. Generally, sensitivity for endoscopic ultrasound is quite high, but that's a very invasive procedure. MRI and CT are less invasive, but you see significantly lower sensitivity in particular, where those approaches just really struggle to identify those small, early-stage pancreatic cancer tumors. On this slide, we share those results side-by-side with what we've seen from the Pancreasure test. in our VERIFY study that was just completed this quarter, as well as the CLARITY study that was announced in December. What you can see is that from a sensitivity standpoint, the pancreas sure test outperforms MRI and CT, and from a specificity standpoint, really outperforms nearly all of those approaches. And so we really feel good about the accuracy of this test as we prepare to launch it into the market. One of the things that was also very exciting coming out of the VERIFY study is that we were able to look at different high-risk groups by combining data from VERIFY and the CLARITY study. Between those two studies, that gives us almost 1,500 patients that we can look at to say, how does the test perform in these different high-risk groups? So we looked at those that have family history and genetics, those that have diabetes, as well as people who have those pancreatic cysts, those fluid-like sacs on the pancreas. As I mentioned, those cis patients are especially difficult to classify as either having cancer or not. And yet you can see the sensitivity of our test was still high in that group at 72%, and the specificity came in at 89%. Familial and genetic, we have a large cohort of those patients, nearly 1,000 patients between the cases and controls. And you can see those very strong results with 78% sensitivity and 94% specificity. While this group of diabetes patients is not the new onset diabetes group that is at incredibly high risk for pancreatic cancer, it is encouraging to see the results in a general diabetes population to come in as strong as they did here. As we think about what comes next, our transition to the commercial phase is progressing very well. We've talked about the fact that as we moved from 2024 to 2025, we would continue conducting clinical studies, but we would also be moving into the commercial phase, preparing for our launch in September, and also working to secure a commercial partner to help us market and sell this test in the large, attractive U.S. market. Let's talk a little bit about that launch preparation. One of the things that has been very exciting to see is that as we approach launch, more and more anticipation and excitement is building for the pancreas share test. On the right are key activities that we've been conducting within Immunovia in order to prepare for a successful launch. One of the most important things we can do is define our target audience effectively and identify those physicians and high-risk surveillance centers where we have the greatest opportunity to move volume and generate revenue and to do that with a very lean, very efficient, limited, and targeted commercialization effort. As we think about transitioning to the commercialization phase, we're also very, very focused on how do we commercialize this test at a low cost that does not increase our burn rate in the short term. So we're looking at a lot of ways that we can design efficient processes, processes that we can automate, and steps in the process that we can outsource to others in order to lower our costs both on a per-test basis and also to lower our fixed costs so that as we start to ramp up our volume during that ramp phase, our fixed costs are not too high. Those are pretty internally focused, but if we think about some of the external things that are happening, we're in conversations with multiple patient advocacy groups and physician associations where they can help us get the message out about pancreasure when the test is ready for launch. Those groups have already been helpful in multiple ways. For example, we have been conducting focus groups of high-risk individuals to do things like evaluate our test report to make sure that it's understandable and that it's clear. We've also been talking with those groups about our messaging and talking with the people who we really need to convince about the benefits of pancreas sure. So as we approach launch, our collaboration with these advocacy groups will just continue to get higher. You can see on this slide, this is just a simple example of some of those automated processes. And I say simple sarcastically because this process is quite complicated. There are a number of steps. And as we put these kinds of flow charts together, and this is just a small slice of the activity, It gives you a sense of how complex these can be, but also the fact that we're taking a very structured approach in order to build processes that are efficient and allow us to be a really low cost operation. We were also very excited as we prepare for the launch to roll out our new branding and our new brand identity. As part of that, we redesigned the Immunovia logo You can see here with the new logo, we have a very clean, very approachable, it's a modern logo, and it leverages bright, vibrant colors. We also use shapes to communicate about the test. So, for example, you see here this essentially shaped almost like a drop of blood. And in addition, in the center of that drop of blood, you have the clarity and the focus that we hope to provide to physicians and to patients who are at high risk for pancreatic cancer. We've heard great feedback from physicians and high-risk individuals about the new look, and we're excited to roll that out as part of the materials that we'll be doing as we prepare for launch. One of the key steps there was to relaunch immunovia.com to make that site simpler and easier to navigate, and to make sure that we are effectively communicating what Immunovia can do and how the pancreasure test can really benefit those high-risk individuals who really are searching for clarity and reassurance about their high-risk status. We also developed the Pancreassure name and, again, have received very, very positive feedback from physicians on that name because of the fact that it really clearly communicates exactly what we want to achieve with the test. We are attempting to provide that reassurance, that clarity, and the confidence that that patient can go through to their next review knowing that, again, they've got the accuracy of the pancreas share test behind them. One of our other key steps as we approach launch is scientific dissemination. This essentially means going out to large physician conferences, sharing data from our clinical studies, and securing input and feedback from physicians. As we undertake this effort, we work very, very closely with the key opinion leaders and physician researchers who have been so vital to the conduct of our clinical studies like CLARITY and VERIFY. On this slide, you see a picture of Dr. Amy Lucas, who is the lead author on the CLARITY study. This is from a presentation that Dr. Lucas gave at Digestive Disease Week last week. Digestive Disease Week, or DDW, is the world's largest conference of gastroenterologists and includes thousands of GIs, primarily from the U.S., but from around the world as well. We were very excited that at that meeting, the CLARITY study was selected as a plenary presentation of of distinction and was highlighted in the end of the conference Best of DDW presentation, really speaking to the fact that there's an important clinical need here that has been met with this test. And I think it also says a lot about the rigor and the quality of our clinical study to be selected for those honors. We've shared the data at other conferences. Beyond gastroenterology conferences, we're going to cancer conferences as well and had a very, very strong reception to our data at the American Association of Cancer Research meeting as well. A quick review of our financials as we think about how do we ensure that we have sufficient resources in order to support the launch and the clinical studies to secure reimbursement at the end of q1 our cash balance was 37.7 million krona our cash burn for the quarter was 8.1 million sec per month and that was at the lower end of the guidance that we have given That cash burn is consistent with what we've had throughout the last 12 months, and we expect that level of spending to continue. What that means is that if we have shifted our focus on commercialization and to clinical studies to support reimbursement, we've looked for savings and ways that we can reduce costs on administration. or reduce costs on development and R&D in order to continue to operate at that same level of spending while we ramp up the resources devoted to commercialization and to clinical studies. Based on our current cash balance as well as our expected burn rate, we expect that our current cash should fund our capital needs through late third quarter of this year. At this point, I'd like to just say a quick thought about why we think Immunovia can be such a compelling investment opportunity. Oftentimes on these calls, we talk about the pancreas sure test, the clinical data behind it. We talk about the company and how we're operating, but we don't talk a lot about Immunovia as an investment. And I wanted to just take a moment to talk about three reasons why I think Immunovia can be a compelling investment at this point. The first is the attractive valuation. If you look at the assets that we have, how far we've progressed, what has been invested in developing the pancreas sure test to have a market capitalization of 118 million SEC speaks to the fact that there is significant upside in the company. When you look at the assets of our company, we do have that fully developed next generation pancreatic cancer test. We talked about the two clinical validation studies that we've done, VERIFY and CLARITY. We have a pipeline of additional clinical studies that are either in process or planned that will support payer reimbursement of the test, both by government payers as well as private insurers. And then we have that fully operational CLIA accredited lab in the United States. As we look forward, we see multiple catalysts for Immunovia in the year and year and a half ahead. First is the commercial launch in September of 2025. We'll continue to have clinical results that we release throughout this year and into 2026. As I mentioned earlier, we're actively seeking a commercial collaboration partner, and I'd just like to say a little bit about that here. As you can imagine, we can't share a lot of information about those discussions because of the confidential nature of those conversations. What I can tell you is that we have spoken with a large number of top diagnostics companies. These are companies who have an interest in early detection. They have strength in oncology and, in many cases, in the markets where we will be competing. And they are really intrigued by what they see in our tests and in the clinical data supporting it. I mentioned that we had been at the DDW conference last week. That was a great opportunity for us to have several of these meetings and to do it in the context of a conference where there was a lot of positive energy about Immunovia and about our pancreas sure test. One of the things that will be critical is convincing those companies that we are on track for reimbursement. And the first focus for us for reimbursement will be Medicare. And we're aiming for second half of 2026 to be the time when Medicare, that government payer in the U.S. for people over the age of 65, gives us positive medical coverage policies. As we close and before we transition to Q&A, I just thought I'd share one additional story with you. And it's actually fairly similar to the story that I started with, but it's a second different physician. This is a woman who practices and does research at one of the most prestigious institutions in the U.S. She is a cancer researcher who is looking into developing therapies for a variety of different cancers. Unfortunately, she herself has genetic mutations that put her at risk for pancreatic cancer, including having lost her mother to pancreatic cancer. Unlike the woman that I mentioned earlier, this individual is incredibly proactive already about monitoring for pancreatic cancer risk. Every year, she goes and does an endoscopic ultrasound. Every six months in between, she does an MRI. And yet despite that, she said she still has anxiety about whether she can catch pancreatic cancer early if it comes. She has been following the progress of Immunovia and reached out after the publication of our Verify study results to find out how quickly the test would be launched and when she could get access to it. She's become a great advocate for us. She introduced us to the leader of the pancreatic cancer program at her institution. She also introduced us to a large investor who has interest in pancreatic cancer. So it speaks to the level of excitement that she has about Immunovia and about the Pancreasure test. And I think that's emblematic of what we see across a number of individuals, both physicians as well as high-risk individuals, who are very eager and excited to have the pancreas share test launch. With that, I'll open it up for questions and would love to hear what you'd like to know more about.

We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on their 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. Questionnaires on the phone or requests are disabled in loudspeaker mode while asking a question. Anyone who has a question may press star one at this time. The first question comes from Elhama Niklas from Carlsquare. Please go ahead.

Yes, hello, good morning, and thank you for taking my question. I was wondering a little bit about the launch efforts and how will that look like in the sort of order flow and initially before you sort of have your test integrate into the sort of EHR systems?

Yes. Yes. So what we will do is we will have an online portal where physicians or their staff can go in, place an order for the test. That portal is being designed and optimized for simplicity. One of the things that's been very helpful is that we have a small focus group of physicians who used the Emre Pankendi test in the past and who plan to use this test, they have been meeting with us, helping us figure out how do we make that ordering portal as seamless and as clear as possible. Initially, that will be the way that tests are ordered. Once that test order comes in, we will provide the kit that will be used to collect the blood. In some cases, that collection will happen directly on site at the high-risk surveillance center. That would certainly be our preference because then it can move very quickly. We also have an option where we can schedule an appointment to draw that blood at one of thousands of centers across the United States. And that's another example of where we're working with an outside partner to really streamline and automate that process. Once we have the blood sample in-house, we'll report back to the physician through that same online portal where they place the order. You mentioned the EHR integration. That is something that will come later. But one of the things that we found is that by making the portal as simple as possible, we can get around some of the concerns that sometimes come up from physicians about things that are out in the portal.

Okay, great. Thank you. And regarding sort of your pipeline for clinical studies? Yes. Are you able to mention something about what is perhaps ongoing and planned at the moment?

Sure. So there's really a couple different categories of studies that we're doing. I would say the most important category of studies is clinical utility. So what we mean by that is conducting studies where we don't just show that our test is accurate and that it can select appropriately whether that blood sample is cancerous or not. In a clinical utility study, what we're trying to show is that there's a patient benefit to using the test or that physician decision-making is different because of the use of that test. And so we have a couple of clinical utility studies that should be relatively quick to complete that are in the near term, and then we have some that will be longer-term studies. As we've announced previously, we have two clinical utility studies that have been funded by the National Institutes of Health. Those will kick off later on this year. And then we've got a couple of other things in the works as well. The second category is more clinical validation studies. And the goal there is just to continue to build the evidence around the accuracy of our tests in different high-risk groups. So we hope to announce the kickoff of one of those studies here over the next five, probably the next month or so, and that'll be another retrospective case control study that allows us to look at, you know, a different patient group.

Okay, great. And just, I mean, a very sort of current topic, maybe a bit premature for you, but since you're getting closer to commercialization, I'll ask it anyway. So, How about tariffs? Are you, since you're mainly focused on the U.S. markets, how do you see these trade wars impacting your cost and sourcing?

It's a great question. I think, like a lot of people, we are eager to see how things will play out. It's always difficult to speculate, but I would say the strong consensus is that those tariffs will come down For us, the way that it primarily impacts us is that we do get some of the biomarker reagents from a supplier in Europe. So we will be paying tariffs on those unless those tariffs are reduced or eliminated. A lot of our other supplies come from the U.S. We don't have great visibility into the supply chains behind those products. to know how much those prices may increase. But it speaks to why it's so important for us to look for other ways that we can reduce costs, because we know that that is a potential cost additive. And so we want to be able to identify savings. And that goes back to what I mentioned about a lot of the process design and automation work that we're doing.

okay thank you and and regarding the sort of uh reimbursement uh uh important process exciting to learn about the uh the partner interest in pancreas sure and regarding medicare coverage what do you somehow describe the steps towards uh receiving coverage from from medicare sure so um

There are multiple steps in the process. One is to be able to get a code. So we have applied for a code that describes our test. We are in the final stages of that process and should be notified very quickly that that code has been granted. The next step in the process is to apply for a clinical lab fee schedule rate. This is essentially the price at which the test would be reimbursed once the Medicare decides that they are going to pay for the test. And that process will play out over the summer and into the fall. But we have good confidence based on our experience with Emory Pain Candy. Really the key part of the process is the medical evaluation, where they look at our clinical data and they say, is this data sufficient? And they do that, and I think you know this, they're going to look at three categories. They're going to look at analytical validation, clinical validation, and clinical utility. As we think about those three categories, we feel very confident in the data that we have on the analytical validation side. We've obviously talked about the two clinical validation studies we have, and we'll continue to build out our data there. So we feel very good about that category. Final category is clinical utility, and that's where we need to do those additional studies in order to have that portfolio of data that really convinces Medicare that this is the right thing to cover.

Yes. Hello, Jeff. It's also Herman from CallSquare here. Just also a quick question about, so pancreatic cysts, you mentioned in the report that you're total addressable market in terms of patients has doubled. Can you please expand a bit about how you see your addressable market increasing from practice?

Sure. So at most of the academic institutions and health centers that we go to, they will often have two different programs running at the same time. One program is for people who have family history or genetic mutations that put them at high risk for pancreatic cancer, but they'll also have a cyst clinic as well. That cyst clinic in many cases is about the same size or in some cases is even larger. What happens is people go in, maybe they have an MRI or an x-ray for another reason, and a cyst is identified on their pancreas. Once that happens, even though that identification wasn't intentional, once that cyst is identified, they often get put into one of these surveillance programs. And so we see that as an attractive market. The data is a little bit hard to come by in terms of the size of the market, but I would say what physicians tell us is that that market is essentially about the same size as as the family history and genetic mutation group. And so that's why we believe there's probably a doubling of our total addressable market with compelling data in that cis group.

Thank you. And finally, we already talked a bit about tariffs, but there was also some foreign exchange turbulence during the quarter with regards to the Swedish crown and the U.S. dollar. Will you hedge this in any way going forward, or is there a way for you to manage it so it doesn't become as big as a problem, or is it impossible to avoid?

Yeah, I would say, and we evaluate this periodically, as we've evaluated it so far, we have not seen the cost of hedging as being worthwhile relative to the benefits, just because of some of the, you know, just the costs that come along with that. As we move into a situation where more and more of our costs are in U.S. dollars, that may be something that becomes more attractive. And so I think it's something that we'll continue to look at.

Okay.

Thank you. Sure. For any further questions, please press star followed by one. Ladies and gentlemen, there are no more phone questions. I would now like to turn the conference back over to Jeff Borcharding.

Yes, and we'll answer questions that have come in through the chat. If you haven't asked a question but would like to, please feel free to use that chat feature. We do have a question here asking how far along we are in talks with potential investors. I would say that the process of talking with investors is an ongoing one. We really never stop. Part of what we know is going to be important is to make sure that we have a sufficient flow of funds in order to support our growth, in order to support the commercial launch, and to fund the clinical studies. And so I would say I feel relatively good about where we are. It's a difficult environment, but there is definitely a lot of interest in early detection And I think investors feel very positive about the progress that we've made. They also have commented on some of those factors that I laid out earlier. You know, some of the feedback that we've gotten really drove the creation of that slide where different investors have gotten far enough into the process to say, you know what, we're really impressed by the assets that you have. We see these potential catalysts going forward, and we see an attractive valuation. So, you know, again, we feel cautiously optimistic about those conversations. Other questions on the chat? Yeah, so there's a question. What are the plans for financing after we get through the third quarter? It's probably a little bit preliminary for me to lay out exactly what those financing options look like. But I do want to reassure everyone that we are actively looking at that. We are evaluating different sources of capital with a goal to raise the funds that we need. And as we do that, try to minimize the dilution and the impact on current investors. So we're well into that process now and should have more details to share on that in the coming months. One of the questions that we've received is about competition. And it's sort of in two parts. How do you see the competition from multi-cancer early detection tests? And then how do you see the competition in pancreatic cancer specifically? So I'll start with pancreatic cancer specifically. So we feel very good about the tests that we have for a variety of reasons. One reason is the sensitivity of the Pancreasure test. Because we're looking for proteins, we've been able to show that high sensitivity where we find 77 or 78% of stage one pancreatic cancers. That's better than what we see from competing technologies. And I think there's a technical reason for that. So competing tests in most cases are looking for circulating tumor DNA. That's essentially what happens when a person has a cancerous tumor. As that tumor grows and progresses, it starts to shed little bits of the tumor into the bloodstream, and those little bits of the tumor have different DNA, and that DNA can be measured to identify cancer in the body. What we know is that pancreatic cancer tumors tend not to shed a lot of DNA. And so it makes them difficult to identify at stage one and two. It's a fantastic way to identify stage three and four pancreatic cancer. But by then, as we've talked before, it's really too late. So it's really that sensitivity that sets us apart on the pancreatic cancer side. And then on the multi-cancer side, I would say, similarly, they're using that circulating tumor DNA technology or other DNA-based technologies where they're looking for evidence of a tumor. What we saw at the DDW conference was a series of presentations from different makers of those multi-cancer early detection tests, and they showed consistently disappointing results in pancreatic cancer. So, for example, the garden test in multi-cancer early detection released results showing that the sensitivity of their test in stage one and two pancreatic cancer was only 50%. And that's consistent with what we've seen from others. So we really do think that we've got a sensitive assay that can compete with those other blood tests that are out there. And as I showed on the previous slide, can really compete effectively with the imaging approaches that are used today. And with that, I think we've come to the end of the questions. I would just like to close by saying thanks again for spending time with us, either this afternoon if you're in Sweden, in Europe, or this morning if you're in the US. We appreciate your support. We're very excited about the launch of the test in September, and we're looking forward to bringing the test to market and continuing to do the work that's required in order to get reimbursement. Thanks very much. Take care and have a great day.