Immunovia AB

Ladies and gentlemen, welcome to the Immunovia Q3 Interim Report 2024 conference call. I am Yousef, the chorus call operator. I would like to remind you that all participants will be in listen-only mode and that 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 zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Karin Almqvist-Levendahl, CFO. Please go ahead.

Thank you very much. And with that, I would like to say a good morning and a good afternoon and a warm welcome to all of you joining today to Immunovia's conference call following our third quarter results for 2024. Presenting in the call today is our CEO, Jeff Borcharding, and myself, Karin Ahnqvist, CFO of the company. As usual, the presentation will be followed by a Q&A session, which will be guided by our operator. You are welcome to give your questions in the call or post them via the chat function. After we have closed today's call, you will find the presentation and the recording on our website. And with that, I'd like to hand over to our CEO, Jeff, please.

Thanks, Karin. Thank you all for joining us today. I'm very excited to share our progress in Q3, as well as the progress that we've made since the close of the quarter, and to look ahead to 2025. We continue to achieve the milestones that we have laid out for you, our investors. We continue to see strong performance from our next generation test. And as we think about the transition in 2025 into a commercial company, we'll talk more about what's coming as we make that transition. Our agenda will start with a look back at the third quarter. We will talk through the results that we saw from the next generation test in the studies that we conducted in the third quarter. We'll also talk a little bit about the ongoing clinical validation that we're doing of the test. And then from there, we'll transition into a discussion of our financials and cash position before we do that preview of what lies ahead in 2025 and close with questions and answers. This is a slide that you may have seen before, and it really lays out the roadmap that we put in place two years ago to outline the work that we were going to do to develop our next generation test when we made the decision to transition away from the Emory pan candy test. We went through the research phase followed by the development phase where we shared the discovery results previously. That was where we had identified those proteins that were capable of detecting pancreatic cancer and detecting it at stage one and two, that point in the process where if we catch the cancer at that point, survival is more than 10 times higher. Following the discovery stage, we moved into the model development stage, and we shared a preview of those results on last quarter's call. And I want to go into a little bit more detail about the results that we saw in that study where we selected the final five biomarkers. We defined the test model and then demonstrated the accuracy of that model. So looking at the sensitivity, looking at the specificity. From there, we completed the analytical validation, and I'll share a little bit more about that with you today. That is more of a technical review of the individual tests that we will do to measure the specific proteins that make up the tests. It's a very technical exercise, very much focused in our lab. and is intended to give us confidence that for the five biomarkers that we've identified, we are measuring them in a way that's accurate, it's precise, it's repeatable, and it is stable across a variety of conditions. And now we're in the process of clinical validation. Essentially, this is to take another look at the sensitivity and the specificity of our new test and see how that compares to what we saw in the model development test and how it compares to the standards that we have set for the new test. So let me go back and just make sure that we're all clear on the performance of the test that we saw in that model development study, which was completed in Q3. The test model showed 85% sensitivity and 98% specificity. And you see here an illustration of what that means. Sensitivity essentially means if cancer is there, do we find it? So what we would expect is that if we had seven patients with cancer and we tested them, we would find that stage one or two pancreatic cancer in six out of every seven patients, which is a tremendous rate of success given the difficulty of diagnosing pancreatic cancer, especially at those early stages. When we switch over to specificity, essentially what that means is if you test healthy individuals who do not have cancer, do you avoid giving them a false positive? Do you avoid having a positive result that causes anxiety for that patient and requires additional clinical work to be done to investigate? So what we found with 98% specificity is that if we tested 50 individuals who are at risk but do not have cancer, we would only have one false positive out of every 50 patients that we tested. So very, very good accuracy on both the measure of sensitivity as well as the measure of specificity. One of the other key endpoints that we looked at in the model development study was, how does our test compare to CA19-9? CA19-9 is a test that is often used today in pancreatic cancer, particularly for those who have had cancer, to see if that cancer has come back. What we know is that even though CA-19-9 is used, it has some drawbacks. It is not sensitive and specific enough on its own to be used in high-risk surveillance. In addition, we also know that CA-19-9 is not produced by some individuals because of their genetic makeup. So about 10% of the population doesn't produce CA-19-9 at all. And so what we found when we compared our test performance to that of CA-19-9 was that we were 20 percentage points more sensitive. So 85% sensitivity for our test compared to 65% sensitivity for CA-19-9 at the same level of specificity. So very strong results from the model development study. Within that study, we also looked at different subgroups. What we wanted to see was, is our performance consistent across these different groups? For example, do we see equally good results in men and women? Do we see consistent results for both stage one cancer and stage two pancreatic cancer. And as you see here, when you look at the two columns on the right, our specificity and our sensitivity is quite consistent and quite good across these different groups. The one group where you do see lower sensitivity is the low CA-19-9 group. I mentioned in the prior slide that CA-19-9 has this disadvantage. It has a drawback in that some people don't produce CA-19-9 or they have low CA-19-9 even if they have cancer. What we did in our study was look at what happens for those patients that have a low CA-19-9 score. Can we still have reasonably good test accuracy. And what you see in the second line is that our specificity at 98% delivers sensitivity at 60%. So we would capture 60% of those cancers in a positive result. Conversely, CA-19-9 would miss almost all of those cancers. And so again, for that low CA-19-9 group, a very good result and one which gives us confidence in the other biomarkers that are part of our tasks. Following the model development study and the very positive results we saw there, we moved to the analytical validation. And again, this is where you look at those measurements of the individual protein biomarkers. So we're not necessarily looking at the overall We're looking at the specific protein biomarker tests. And can we measure those proteins precisely and accurately and in a way that's stable across a variety of conditions? We conducted more than 20 experiments in a variety of conditions. We followed guidelines for that type of study, completed that on schedule, and really saw excellent technical performance in measuring those target proteins. So we were very pleased with the performance of these assays, particularly because proteins can be difficult to measure. And we saw very strong, very clear results when we did the analytical validations. We're now moving, as you saw on the timeline earlier, to the clinical validation study. And we have begun that study. And essentially, our goal here is to evaluate the accuracy of the test in a different set of samples than the ones we used in the model development study. So this will be a case control study. And what that means is that we will use blood samples, some of them are from patients with pancreatic cancer. A lot of the blood samples are from high-risk people who do not have pancreatic cancer. Those are referred to as controls. Essentially, we run the test in a blinded fashion so that people in the lab do not know if a given blood sample is cancer or is a control. Then we look at the results to see how accurately we captured the stage 1 and 2 cancers and separated them from the high-risk controls. Again, we'll be looking at CA-19-9 alone in addition to the overall performance of the test, and then we'll also be looking at individuals 65 and older to see what our performance looks like there. We announced a while ago that we had acquired all of the samples that we need to conduct the clinical validation study. This was a significant accomplishment. We acquired more than a thousand of these blood samples, and we believe this is going to be the largest clinical validation study that's been done in pancreatic cancer. We have over 200 cases of pancreatic cancer and more than 800 high-risk controls. It's important to note that high-risk control is a challenging group to show a difference between the controls and the cases. Some companies that are developing these types of tests will test their test model on healthy controls. We think it's important to look at those individuals that are at high risk that may be more difficult to distinguish do they have cancer or not. To get all of these samples, we had tremendous collaborations with the institutions that you see on this slide. We are incredibly grateful to them for their support and for their enthusiasm. They are excited about Immunovia's next-generation test, and so they were willing to give us these precious blood samples for our clinical validation study. And that clinical validation study is ongoing now, and we expect to share results next month in December. And with that, I'll transition over to Karin to talk about our financial plan.