Immunovia AB (publ)

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.

Thank you, Jeff. So we would now look at our financial result from the first quarter this year first of all as Jeff mentioned we have increased numbers of our theft during this first quarter which is one of the reasons for the revenue increase in this quarter well our royalty income also increased during this quarter the revenue amounted to 374,000 SEK comparing to 139,000 SEK in the same period last year, which represents an increase by 169%. As we described before, we are still in an early stage in our revenue recognition from this test. Our external expenses amounted to 8.9 million SEK during this first quarter, comparing with 8.1 million SEK last year same period. The increase in our external expenses is related to our increase in commercial activities. At the same time, we reduced our R&D costs during this quarter, meaning that we now allocate a major part of our costs to commercial activities. Our personal expenses amounted to approximately 9 million CX this quarter, comparing to 9.2 million last year. During the quarter, the average number of employees was 15, compared to 9 last year. In the first quarter last year, our accrues related to some personal expenses was lower than actual, which resulted in that the personal expenses being significantly higher during that quarter. Our operating loss for the first quarter amounted to 18.4 million SEK, comparing to 18.9 million SEK last year. During this quarter, our total operating expenses were slightly lower, while the total revenue was higher compared to last year. The total loss for the purchase was 18.4 million SEK, comparing to 57.8 million SEK in the same quarter last year. This corresponds to an earnings share before the delusion of a loss of 0.03 compared with the loss of 0.24 last year same period the reason for the the reduced fluctuation the currency effect during this quarter is that we now convert internal lows into equity between the current company and the US company we do not have any other major currency effect in our P&L during this quarter well during this quarter we maintain strong cost control and high operation efficiency as we have mentioned before meaning that we remain below our previous estimate estimated monthly cash burn in the first quarter of these years we have an average cash burn of approximately 6.9 million per month which is lower than our guidance of 8 to 10 million per month our cash position at the end of march was 56.1 million Our current cap decision will take us through the third quarter of these years to fund the targets that we have been describing before. Well, thank you for me. Over to you, Peter.

Thank you. Yes, and before we go on, let me just say that I hope you got a feel for what we have accomplished and what we want to accomplish going forward to make Immunovia a success. And the only way you can make Immunovia successful is by having, I would say, excellent staff in the company and an excellent leader which shows the staff the way to go and how to deliver. And here we are very, very lucky. And obviously, to ensure that people continue working hard and deliver the right things, they need to be acknowledged both by words, but also by incentive programs. And this is what I'm going to talk about now. But before going into more details about that, I would also like to say in a small company like Immunovia, the board is actually also hands-on in business development activities to support GEF. If negotiations come up and if we come to contract stages, the board is ready to step in. So this is why it is also important for the board to be incentivized along the company goals in general. So if we switch to the next slide, Jeff. This basically gives you the high-level goals for Immunovia 2026. And you can see you have four goals. The first one is not surprisingly to basically make the Pancreasure test a commercial success. The next one is to lay the foundation for meaningful reimbursement in 27. And the next one is, as Jeff outlined, to find a partner which can further fuel the commercial success of Pancreasure. And including in that part is also looking into, you could say, partnership beyond just sales partnership in the U.S. It could also be out licensing activities, for instance, in Asia, etc. And the final goal is really to secure funding going forward. and to ensure that we can actually fuel the commercial expansion. And this is the high-level company goals, which basically also reflect the goals the board have discussed and set for Jeff. And then each individual in the company are then linked up to one or more of these goals, which will be reflected in the cash compensation for the individual in the company. So this was the management incentives and the Immunovia Gold 2026. If you move on to the next slide, Jeff, I just want a very high level to also tell you about what happened for the board following the meetings in the nomination committee. So the nomination committee have had several meetings, and the decision here and recommendation to the AGM in next week is that we keep the cash compensation for the board unchanged from 2025, but that we put a new stock option program in place for the board, and that this stock option program are aligned with the company goals. So this means that this stock option program will vest in 2027 at the AGM, conditional on a continual board membership for all board members, But the new thing is that exercising is only possible upon an exit event for the company. And what does an exit event mean? Well, that's stated down at the bottom. An exit event of Immunovia is, by the nomination committee, defined as a public takeover of a toy Immunovia, a merger or a business combination, leaving current shareholders with less than 50% of the voting power, or a sale or exclusive out-license of our test, including all materials and the IP, or it could finally be a sale or acquisition of more than 90% of the voting shares by a person or a concept group. So this means that we have actually aligned the board to support that Immunovia moves in the direction of a major commercial partnership or maybe even a takeover in case such a one with, you know, the right offer comes on the table. So with these words, I want to say thanks for today and then handing over to the Q&A session.

We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one 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. Questioner on the phone, I request to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time. The first question comes from the line of from Cal Square. Please go ahead.

Yes, good afternoon, and thank you for a great presentation covering a lot of topics. According to the annual report, it states that one priority is to increase market penetration of bank cash flow in 26. So is it possible to be more specific? I mean, in some way, you've already achieved increased penetration by increasing the number of centers to 21, for example.

Yes, thanks for the question, Nicholas. I think that we have, as you noted, not given specific guidance on the number of centers that we have on board. I guess what I would say, though, is that there are about 200 high-risk surveillance programs across the United States. And as you saw in our pipeline slide, we are speaking with several dozen that we have not yet brought on board. So I think while we feel good about the 21 centers, we would be looking at, you know, a multiple of that that we want to achieve, you know, later this year and into 2027. Okay.

Thank you. And regarding... turning a bit into financials, if I may. You're not breaking down sales in terms of tests and royalty revenues, respectively. But is it possible to say if there was an increase in test sales versus the previous quarter?

Yes, I can answer that. So, there was an increase in sales revenue versus the prior quarter. At this point, the revenue that we're generating is fairly low. It's pretty minimal, and the reason for that is twofold. One, we're still ramping up volume. As we've noted, our focus is on bringing centers into the franchise, and it does take time to ramp the volume. The other piece is that from a timing perspective on the revenue, there is often a delay in receiving payments, particularly, as I noted, as we start to bill insurance companies in February, those payments often come quite a ways down the road. And so it will take us some time to be able to estimate what the revenue is from those. So we'll be working through that. But what I would envision is that as time goes on, we will certainly break out payments the revenue from royalties and pancreasure sales. At this point, we keep them together just because we're still so early in the revenue generation phase for pancreasure.

Okay, thank you. And we've got one more financial or two more financial questions, if I may. The OPEX, I mean, why is it lower than guidance? I mean, a low cash burn is, at the first glance, is positive, but are you cutting back or something here?

No, I wouldn't say that we are – I guess what I would say is we are not passing up important opportunities to move the business forward in order to save cash. What we're trying to do is look for every opportunity we can to be disciplined with our spending. If you look at the reasons for the underspend in the first quarter – Some of that was related to clinical studies where either we were able to design the study to be run at a lower cost or in a couple cases where certain payments for studies will come later in the year. But certainly, we are looking operationally for ways that we can save money. different ways that we can be as efficient as possible. For example, we're taking advantage of all those opportunities, and that's where you see the savings.

Okay, but sort of previous guidance stands now going forward, if I'm correct.

Yeah, I would say we expect to be more in that 8 to 10 million set per month range going forward as we continue to see some of the clinical studies spend in line with what we expect.

Okay, great. And sort of the clinical utility studies that you just mentioned, like, assure that you just launched? What are the sort of primary endpoints here to gauge the impact of clinical utility?

Sure. So the primary endpoint is to look at the impact on clinician decisions based on the pancreas sure test result. So if you think about a positive pancreas sure test result, that should lead to the physician taking action to further investigate that. So given that most of the people in the registry will already be part of a high-risk surveillance program, a positive pancreas sure test, we expect would lead to either an immediate step to conduct imaging like an endoscopic ultrasound, or if the patient is already scheduled for imaging, maybe the timing of that imaging is moved up so that the patient is seen more quickly. Conversely, a negative pancreas sure test would suggest that we don't see those signs of cancer in that patient. And as a result, either they can continue on the high-risk surveillance program protocol that they've been on, or there might be an opportunity to extend the interval, extend the time until that next imaging is done. So we'll be looking at those types of changes for the primary endpoint. I will say, though, too, one of the things that's really intriguing about a registry study is that we will be collecting a wide range of information on how the test is used. And so we'll be able to look at a lot of different analyses. That analysis will be really helpful as we are sharing guidance with clinicians to help them understand how are us other physicians using the test and what results are they seeing as a result of that use. So we expect that the registry study will generate a number of publications in the coming years that will help guide clinicians. And as I mentioned earlier, we do think that that information will also help to bolster our submissions to payers over time.

Okay, great. And you also received sort of targets of submission to Medicare by Q3. I mean, that's quite not so long until Q3. So how will you have the time to gather all the clinical utility data needed for that submission?

so uh you know i would say that some of that data the key is that we're either already in the collection phase or or we've you know largely finished the collection phase and we're analyzing that data now the other thing that's important to note about the medicare submission is that we do believe there's an opportunity to submit data after the initial submission. So, while we will make the initial submission on the timing that we talked about there, there is an opportunity to continue to provide additional clinical data as it gets published later in 2026 or even potentially early in 2027.

Okay, great. And you also mentioned longer-term And in that respect, I was curious about your thoughts about the regulatory pathways here. Are you having any discussions with the FDA and targeting sort of FDA clearance at some point?

Yes, we have had one discussion with FDA, and I would expect that we will have a second discussion with FDA in the next few months. We continue to think through what a submission for FDA approval would look like, and certainly the studies that we talked about today could really be an important part of a submission to FDA for their approval.

So how significant do you believe FDA clearance is to achieving a substantial

You know, I think the reality in the U.S. is that as a lab developed tests, we don't need FDA approval. I do think FDA approval can help in a couple ways. One is that there are laws in some states within the U.S. that require payment of biomarker tests. Those laws are relatively new, and it's not clear what the level of adherence to that will be by the payers. But FDA approval is certainly important in getting reimbursement under those laws. So that's one of the key ways that we think that it can be helpful. I do think it's also helpful particularly for commercial reimbursement and securing commercial – coverage decisions, there are some payers who will look at FDA approval as one factor. So, I think it's meaningful and we are eager to pursue it.

Okay. Thank you. Thanks for great answers. Thank you.

Thanks very much, Nicholas.

There are no more questions at this time from the phone.

We do have some questions from the chat. One question, are the sales reps focused on certain states? And if so, what's the strategic reasoning behind it? Well, their territories are defined by geographic borders, but I would say generally speaking, we have divided the country among the three strategic account managers. And our goal is for them to call on the large high-risk surveillance programs that exist throughout their region. So we are focused more at the top of the market and those high-risk surveillance centers more so than focused on certain states geographically. Having said that, there are some states that are important to us. I mentioned on our last call that we received approval from the state of California. That has been very helpful to us. We've now got multiple high-risk surveillance centers in California, and we'll be looking at others as well. In addition, we've talked about the fact that we are pursuing approval in New York State. New York State at this point is the only state where we are not yet approved. Pancreas sure is approved in the other 49 states. New York has by far the most rigorous review process. In terms of an update there, which is one of the other questions, when do you expect to be approved to sell to New York clinics? We are working through the discussions with the state of New York now. They've already conducted a review and inspection of our lab, and they're going through some detailed data about the pancreas sure test now. We have another submission to them, which will be coming up here later in May. So, I would expect that that would happen over the next few months. The good news is that New York law has changed, and we are able to enable clinics in New York to use the test in the meantime. And so while we haven't done a full launch, we are starting to sign up some clinics in New York and do some limited testing that will certainly accelerate once we have that approval. Received the question, what is the gross margin of the test and how does it scale? We haven't disclosed the specific gross margin of the test, primarily because at this point it's difficult to pinpoint exactly what our average selling price will be. Having said that, the cost of the test is relatively low. It's a protein-based test, which gives us a cost advantage versus other surveillance tests that are in the market. So we feel good about the gross margin that we will have, and we believe that the gross margin should scale effectively as the business grows, and certainly we're looking at that over time as well. You mentioned that you were looking into potential licensees in Asia. Could you add a bit more flavor on this and to which companies you have reached out to? So, while I won't disclose the specific companies that we have reached out to, I will share that our initial focus in Asia is on the countries of Japan and China. Those markets have a real focus on early detection. They have groups. both in the government and in the healthcare community that are very committed to early detection. In addition, pancreatic cancer is more prevalent in those two countries than in most other countries around the world. And they offer an attractive financial opportunity as well. So those are our two focus areas. We are speaking with diagnostics companies that have a presence in those two countries and hope to be continuing those efforts. In fact, next week I will be heading to China to speak at an early detection conference and we will be having meetings with potential partners there. Maybe we've got a question here about In the call, you spoke about wanting the right fit for a U.S.-wide and potentially global partner. What does the right profile actually look like for Pancreasure? And what kinds of activities is the company engaging to cultivate those dialogues? So I think there are a few things that make for a really good partner for us. One is a commercial team that has a strong presence among physicians who would be in a good position to use the test. That's probably the most important factor. One of the other things that we'll look at is what other resources does that company bring to the table and what other strategic benefits do they offer? For example, some of the companies that we're talking to do other tests that would naturally pair well with a pancreas sure test. So you can envision how one of their tests could lead to a pancreas sure test following that. And in terms of what kinds of things are we doing to engage, certainly a lot of it is attending industry conferences. That's a great opportunity for us to meet with these companies. Those scientific conferences as well allow us to meet with their R&D teams. But then a lot of it is very traditional business development activities of sharing information as we have it and scheduling calls on a regular basis to keep those companies up to date on what we're doing and what the opportunities to partner might look like. We're almost out of time here, so let me just see. If there are – one of the questions we received was several of your collaborations are with top-tier academic centers running PBAC programs. How do these partnerships strengthen the case for coverage? I think they strengthen the case for coverage in a few ways. First, as we go to payers, we want to make sure that we have advocates standing alongside us and advocating for Pancreasure coverage. These key opinion leaders can be those advocates. The second benefit is that they will help us generate real-world data through the Assure registry as well as through other clinical studies. And then the final thing is that payers also consider guidelines that are published by different organizations to guide things like surveillance of people at high risk. The authors of those guidelines are many of the people who are using the Pancreasure test or people that we're talking to about coming on board and using Pancreasure. So it's really those three things that we think allow us to have a good opportunity to leverage the advocacy of our early adopters to help us support coverage decisions. Okay. I think that takes us to the end of the hour, and certainly we know that this has been a longer session than normal, but we thought it was important to share with you the key developments that we've had recently, but also really map out what the rest of 2026 looks like. and hopefully dive into some areas that we typically don't have as much time to get into. So my hope is that through this conversation, you have a better sense of where we are, what we've accomplished recently, and some of the really exciting things that lie ahead as we pursue coverage, as we pursue a strategic partner, and as we look at growth opportunities like innovation, AI-based models to identify even more high-risk individuals. All of these things are critical to us achieving our mission. They are critical to us creating shareholder value, and they're critical to us building a business that truly capitalizes on the potential of the Pancreature Test to make an impact in early detection of pancreatic cancer. Thanks very much for joining.