Immunovia AB

Good afternoon and good morning and welcome to today's q3 interim report for any novia We really appreciate you joining us today You might notice that we have a different format this time where we are using some new technology that allows us to both save money and Hopefully have a little bit more of a direct experience by sharing not only the slides But also video of the presenters as well I'll be joined by Adam Bookstrom, who is our CFO, as we share results from the third quarter with you today. For our agenda, we will start with pancreas sure trial and adoption. From there, we will go to reimbursement and clinical studies. We'll talk about some of our business development activities and the traction that we're seeing there. Then Adam will share our third quarter financial results. And in conjunction with that, Adam will also talk about the rights issue, which we have announced, in which we will be executing in the coming weeks. And then, as always, we will do a Q&A session at the end. Please note that this time we do not have the phone number for questions, but generally the questions have largely come in through the Q&A function anyway, so we think that'll work well, and we look forward to having any questions come in that we can answer for you. We shared previously as we headed into the year 2026 that we are dedicated and focused on certain key areas that we believe can really grow the business and create value for our shareholders. So the first of those is commercial and really trying to drive trial and adoption of the pancreas share test. We've been able to do that since we launched the test in September of 2025. And I'm excited to share with you the results that we saw in Q3 as that adoption and trial accelerated. Second, we're focused on clinical studies, and those clinical studies really serve two purposes. The first is that they help us to build the evidence that we need to secure reimbursement from patients. payers in the United States and across the world. And second is the fact that those clinical studies provide information and guidance to the physicians who are using the Pancreasure test as part of their high-risk surveillance programs. And then finally, as we've mentioned previously, Immunovia is a small company. We are running lean. We have limited resources. In order to fully capitalize on the opportunity with the pancreasure test, we need partners. We need partners to go outside of the U.S. where we don't have operations. And more importantly, we need partners within the U.S. who can help us commercialize the test and who can bring resources to the table that we just simply can't match as a company of our size. So today's presentation will touch on each of these focus areas. As we start with the trial and adoption, I want to go back to a slide that we've shared now for probably about a year and a half. And this is the overall overview of our approach to launching the pancreas share test. We talked previously about the fact that we wanted to launch the test in a very targeted way and to do that in a phased approach so that we targeted our resources against the most important work at the right time. We started in the initial phase developing advocacy among targeted groups, especially those key opinion leaders who run high-risk surveillance programs across the United States, both at academic medical centers as well as within large health systems. We did that really for the first year of launch. And then as we moved into the third quarter and the results that you'll be seeing today, we started to expand our commercial efforts a bit. In addition to those key opinion leaders and the high-risk surveillance centers, we have also now started to target gastroenterology groups. These are group practices that bring together multiple gastroenterologists to work with patients who need help with a variety of GI issues. These are people who are on the front lines and they can provide pancreatic cancer surveillance for people who may not have access to the top academic centers where they have these well-established programs. We did a pilot in Q3 that will be expanding in the fourth quarter and I'm excited to share the results of that. From there, we'll then move on to the revenue growth stage and that really depends on being able to generate more revenue per test from the Pancreasure test. Before we invest too much in driving volume, we want to make sure that the revenue that we're earning for every test really makes that make sense financially. A key part of this is going to be bringing in that strategic partner, that larger diagnostics company that has a sales team that can really help us expand our reach beyond just the two strategic account managers who are selling Pancreasure today. So, we talked previously about the fact that during the first phase of the launch, that building advocacy phase, that the most important metric was how many high-risk surveillance programs are using the Pancreasure test. I am really excited to share these results. As you can see, we have accelerating growth in the third quarter of 2006. We now have 36 high-risk surveillance programs that are using the pancreas sure test. And not only do we have 36 programs, but these are premier leading programs in the United States. Health organizations like Memorial Sloan Kettering, Northwestern Medicine, Michigan Medicine, Stanford, Beth Israel Deaconess, which is affiliated with Harvard. These are leading medical centers and are regarded as top experts in the field. Having their advocacy is going to be crucial as we go out to a broader group of physicians who may not have that same level of expertise in pancreatic cancer surveillance. If you're a typical gastroenterologist and maybe you've only done a limited amount of screening for pancreatic cancer, you want to know that the experts across the country and in your area are using a test before you take the leap to use it yourself. And so we really feel like we're in a very good position based on the number of programs that are now using the Pancreasure test. I talked last time about the fact that in addition to driving trial within these groups, we want to start driving adoption, meaning that we're moving that clinic from using the pancreas sure test every once in a while or using it in a special case or for a unique high-risk individual to the point where they're using it on a very regular basis. They're comfortable using it. It becomes part of how they practice. That is challenging because you're asking people to change their behavior. You're asking them to adopt something new. We ask them to change their protocols that really guide how it is that they surveil for pancreatic cancer. And so we move these clinics through a process where they start out and we register them. They start in this trial phase where they're just starting to use the pancreas sure test. they're just starting to think about how they might fit it into their practice. And then if they move into the early adoption and full adoption stages, our goal is to work with that center to really think about how their processes should change and what high-risk individuals are best targets for the pancreas share test. And as you can see here, we now have one-third or 12 of our 36 patients high-risk surveillance centers that have reached the full adoption stage. And full adoption means that they've ordered more than 10 tests, and they're ordering consistently quarter over quarter. And how do we do that? Well, at the bottom, you can see some of the keys to moving high-risk clinics from trial to adoption. I mentioned the fact that almost all of these clinics have protocols or processes that they follow. Those are formal documents that we work with them to update to increase the pancreasure usage. The second is that we make sure that we connect with them on a regular basis so that they're thinking about ordering pancreasure on a regular basis. Most of these high-risk clinics operate one day a week, and so there's an opportunity for us to connect with the people in that clinic before they have those individuals coming in for the pancreatic cancer surveillance clinic to remind them about Pancreasure, to answer any questions, to talk with them about previous orders that they placed and the test results that they saw. And then the final thing that we do as we try to move people towards the adoption phase is expand the number of individuals who work at the clinic that are involved in the process. And honestly, this is the most important thing that we can do to drive adoption. Early on, when we're talking to one of these high-risk surveillance centers, we're usually talking to the physicians, the experts who lead these programs. They are often oncologists or gastroenterologists. Sometimes they're pancreatic surgeons. But they are experts in the field. AB AB AB AB AB AB schedule appointments with people who are coming in who could flag individuals and say, this might be someone to take a look at for a pancreas share test. It might be genetic counselors who are also working in the hospital. What they do is meet with people who have had genetic testing, who have identified different mutations in their genes that could make them more at risk for pancreatic cancer. If we can get those genetic counselors to be sending patients to the high-risk surveillance center. We can increase the volume and drive adoption. And then finally, the nurses and what we call the advanced practice professionals. These are people who are sort of the right-hand person of the physicians in these groups who really drive a lot of the day-to-day activity, and we want them to be actively ordering the tests and talking with the physicians who lead these programs about pancreas sure so more to come on this effort to drive adoption but I feel really good that we're seeing early results with the program that we have in place I mentioned that this quarter we have expanded our target audience so it's still targeted don't worry we're not going too broad but in addition to the high-risk surveillance centers, we're now looking at these large group practices made up of gastroenterologists. And it could be 20 gastroenterologists, or it could be as much as 50 or 100 gastroenterologists. Our first pilot was with a group in New York State called Saratoga Schenectady Gastroenterology Associates. They're our first pilot in this target audience group. And they practice in a rural area in New York. So they and their patients are not close to New York City or other metropolitan centers where they could go to one of the high-risk surveillance centers that we've been targeting so far. We worked with one of their physicians to start using the pancreasure test, see how it could work within their practice. And once that pilot was successful, we are now rolling out Pancreasure to the other two dozen clinicians that are at SSGA. Going forward, this group will participate in our registry study called Assure, and that will help generate real-world data and experience that we can share with other gastroenterology group practices. So be on the lookout for more of these group practices to come. We have a target list in key areas where we're looking to prove that this can be a second channel for us to really drive adoption and trial of the pancreas shear test. Let's talk a little bit now about reimbursement and clinical studies. As we've discussed previously, there are three ways that we can get reimbursed or paid for pancreas shear tests. The first is payments from patients. The second is insurance payments that we can receive from commercial insurance companies before we get formal coverage decisions in place. And remember, coverage decisions are when the payer goes through a scientific and medical process to evaluate the evidence behind our test and then make a decision about whether the test is medically necessary. And if so, they'll issue a positive coverage decision. And that's really the third phase of this, is when we can start getting insurance payments after coverage. That's where the payment is more reliable. That's where we can count on more consistent payment and higher average payments from the insurance companies and the government insurers that pay for the pancreas sure test. But before we get to that, we've been collecting payments from patients since we launched the test. At this point, we collect about $200 on average per patient who uses the test, or just over $2,000. One thing I want to highlight is that our collection rate is quite high. We are currently collecting about 80% of patients The bills that we send to patients, which relative to other healthcare practices in the U.S. is very high. What we know, though, is that there's a limit to what we can get in terms of the payments from patients. And that's why we started with insurance billing, the second column in this table. We began in February of 2026, and we're still in the early stages of this process. That might seem surprising given that we started in February and it's now the beginning of November. But the reality is that when you don't have coverage decisions in place, it can take quite a while for these insurance companies to process the claims that we submit to them. We have to register as a provider, and oftentimes they will deny the claim initially when we submit it. At that point, we then file an appeal, which essentially means that we submit more information about the patient, we submit more information about our tests, and really lay out the argument for why we should have coverage. So far, again, this is based on limited data, but I'm very encouraged by the fact that we are getting paid on more claims than we would have expected, and the revenue per test that we're collecting is higher than what we had originally expected. In coming quarters, we'll share more quantitative numbers to help illustrate that once we get more data that helps us understand what that payment might look like going forward. But we were encouraged by that and hope that that can lead to more substantial revenue going forward. And then finally, as we think about coverage, as we've talked previously, the first step in pursuing coverage for us is to submit a coverage determination request to a group called Moldex who evaluates those requests. And I'm thrilled to share that we achieved a major milestone in the third quarter when we submitted that coverage application for Medicare coverage. So if you don't know much about Medicare, and certainly that would be understandable, Medicare is the U.S. government health insurance for people who are age 65 and older. There is a group called Moldex, which is a private company that evaluates diagnostic tests like ours for the Medicare program. And so we submitted our application for coverage to Moldex at the end of September and We're now waiting for their response. And one of the aspects of this system is that there's not a firm timeline in which they have to respond to us. So they can decide which tests to review on what timing and how long those reviews take. So for us, one of the key things that we did in our submission was to really lay out the argument as to why they should prioritize the review of the pancreas share test submission. And the reason is that for people over 65 there is a tremendous burden for pancreatic cancer. Since people get pancreatic cancer late in life, the burden of pancreatic cancer illness and death is almost entirely on those over the age of 65. We are starting to see some younger people get diagnosed with pancreatic cancer. And certainly people younger than 65 are in surveillance. We have a large number of our patients who are not yet age 65. But if you look at the people who actually get pancreatic cancer, they're often over age 65. And so that's really the argument that we laid out for Moldex as to why they should prioritize our tests. So we will share information about this process when we have it. Unfortunately, we will be at the mercy of the Moldex program in terms of what that information is and when we receive it. As we think about how do we bolster our chances of getting that Medicare coverage or coverage by commercial insurance companies, we have a number of studies that are ongoing that support those reimbursement efforts. The DECIDE study is a physician survey that shows how pancreature can change physician decisions about how they do surveillance. We're conducting this with the PROCEED consortium, and we have now collected all of the survey responses, and we are analyzing those as we speak. We announced the results of the adhere patient survey in the third quarter. Hopefully you saw those results. We saw very, very strong interest in the Pancreasure test from patients in that survey. They were highly interested in the Pancreasure blood test with more than 90% expressing a strong desire to use Pancreasure. And they were also interested in how the test could be used. for people who were already using imaging for surveillance, they saw Pancreasure as a good way to supplement that imaging and to make it a little bit easier for them. And for the people who aren't in surveillance yet, maybe they haven't been eligible to start yet, or maybe it's just been too burdensome to do something like an MRI or an endoscopic ultrasound, those individuals were very interested in using the Pancreasure test It's sort of a first step into the use of Pancreasure. From there, we've got our Assure Registry study going on. This is the real-world study of Pancreasure. And then we've also got a study with Kaiser Permanente where we are looking at pre-diagnostic blood samples. So these are blood samples that were collected before an individual was diagnosed with pancreatic cancer, maybe six months or a year or even two years later. So we'll be analyzing those samples to see can we detect the cancer early within those groups. As we transition now to business development opportunities, this is the final focus area that I talk about before we talk about our financial results and the rights issue. And It's always difficult to talk about business development because until you have a deal signed, we certainly want to respect the confidentiality of the process, and we want to make sure that we don't overpromise. I will say that I'm very encouraged by what we're seeing in these conversations. So with U.S. commercialization partners, these are those large diagnostic companies who can help us expand our efforts behind business. selling pancreas sure we've gotten very good feedback from these groups they are impressed by the commercial traction that we've gotten they also have pointed out that we've consistently achieved the milestones that we've laid out because we've been meeting with these groups every six months or so for the last couple years or more and so they see our progress they see us hitting the milestones and so their key question for us at this point is What does reimbursement look like? What's that timing look like? And what are you going to get paid by insurance companies? And so, we'll be sharing preliminary data with them in the fourth quarter with the goal of continuing to increase their interest in partnering with us. We also, as I've mentioned previously, are looking to license the pancreature test in Japan and in China. We have a promising licensing opportunity with a large Japanese life sciences company that has done extensive due diligence and examination of the pancreasure test. We also have a number of early stage opportunities in China. So these are at an earlier stage in the process, but there are multiple companies that we are speaking to in China as well. And then finally, I mentioned during our last call that we have expanded our business development outreach to include pharmaceutical partners. We're speaking with those partners about ways that we might be able to collaborate with them either on research projects or on commercial collaborations. And so we hope to have news about potential collaborations with pharma partners in coming quarters. And with that, I'll hand it over to Adam for the Q2 financial results and a discussion of the rights issue. Thank you, Jeff.

So, we started to look into the financial performance for the first third quarter and the first nine months of this year. All amounts are in the Swedish kronor. Jeff, can you change the slide one, please? Thank you. So if we start to look into our net sales in the third quarter, which increased to 843,000 from 101,000 last year same period, the growth is partly driven by increase in numbers of tests during the period. The growth in the third quarter support the growth of the first nine months of the year. The net sales for the first nine months of this year is amounted to 1.6 million, comparing to 0.3 million last year's same period. Due to the increase in revenue, together with good gas control and lower spam on clinical study during the third quarter, we decreased the operating loss to 17.7 million from last year's operating loss of 25.1 million. The operating loss for the first nine months amounted to 58.9 million, which is lower compared to the last year, which was amounted to 64 million. The improvement in the operating results from the third quarter resulted in lower cash burn in the period. Our cash burn in the third quarter amounted to 5 million Swedish kronor per month, which is significantly below the guidance of 8 and 10 million per month that we previously have been talking about. Our cash position in the end of September amounted to 19.6 million, which is stronger than before guiding, which has also supported the operating to fund the activities until the new proceeds from the right issue will be received in the end of this year.

Yes, we can move on to the next slide, please.