Immunovia AB

Thank you so much and a good morning and a good afternoon and a warm welcome to all of you joining Immunovia's conference call following the fourth quarter results for 2024. Presenting in the call is our CEO, Jeff Borcharding and myself, Karin Ahlqvist, CFO of the company. And as you already heard, this presentation will be followed by a Q&A session, which will be guided by our operator. 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 Jeff. Please go ahead.

Thank you, Karin. I'm very excited to be with you today to share the progress that we've made as we close out 2024 and transition to 2025. We have excellent results that we have shown with our next generation test. We completed the clinical validation of that test in the fourth quarter, and I'm very excited to share those results with you today and also talk about what will come next in 2025 as we move forward to commercializing the test in the back half of 2025. Our agenda will start with a review of that next generation test and its performance in the clinical validation study. Karin will then review our financials from the fourth quarter and our cash position. And then I'll cover our 2025 priorities before we open the call for questions, which we very much would like to have the opportunity to answer your questions as part of that session. It has been just over two years since we made the decision to remove our tests from the market and focus our efforts on our next generation test. During that time, we've made tremendous progress. We've moved very rapidly through the stages of research and development. And we've been able to, over that two-year period, develop a very high-performance test. It started with our discovery study. Then it moved on to the model development efforts. We did the analytical validation, which we finished at the beginning of Q4 2024. And then we moved on to the clinical validation. That analytical validation we won't talk a lot about today, but it is important, and we did complete that in the fourth quarter of 2024. Excuse me. That Analytical validation was a series of experiments that really showed that we have the ability to very precisely measure the five protein biomarkers that are part of our test and gave us confidence as we headed into the clinical validation. And the purpose of that clinical validation was really to look at the performance and the accuracy of our test. Before we share those results, though, I thought it might be helpful to talk about what were our goals when we started development of the next-generation test, and were we successful in achieving those goals? And I'm very excited to share with you that we've made significant improvements in our test when you compare our next-generation test to the earlier Imre Pankanti test. First, we were able to identify higher-performing biomarkers. By adding those new biomarkers to the test, we reduced the test's reliance on CA-19-9, and we can now provide results for all patients. With IMRE, we were limited, and about 10% of the time, we could not provide results because the patient didn't produce enough CA-19-9. That was such an important biomarker in the first generation test that we knew we needed new, stronger biomarkers. In the Imray test, we had nine biomarkers. In the new test, we have five biomarkers. The only one which is consistent is CA-19-9. So we've really, really strengthened the other biomarkers that are part of the test. This also allows us to be able to use the test effectively in patients of all races and ethnicities. One of the challenges with a test that was so reliant on CA-19-9, like IMRE was, is the fact that people who don't produce CA-19-9 are more likely to be Black or Hispanic, and as a result of that, about 20 to 25% of individuals in those populations could not use the M-ray test. The new next generation test can be used across all races and across all ethnicities. One of the pieces of feedback that we heard about the original M-ray test was that people were confused by the borderline result. When we gave an M-ray test result, About 10% of the time, we returned a result of borderline, which essentially meant that that patient was kind of in the gray zone between a positive and a negative result. That created confusion and anxiety for patients. It also left clinicians uncertain about what to do next. So with our next generation test, we have eliminated that borderline category by increasing the precision of our test. We're now able to either give a clear positive or negative result. And that really helps clinicians to know what to do next following the test result. When we made the transition to the next generation test, one of the things that we did was to move away from the proprietary M-Ray platform. By doing that and by adopting a widely used industry standard ELISA platform, we were able to really reduce our costs. And we reduced our costs in two ways. First, the cost per test when we launched the new next generation test will be much lower than what our cost per test was with the Emray test. The second thing, and this is very important for a company like ours, where we're at that stage where we're doing everything we can to preserve cash and not spend capital, is the fact that The new testing platform has very, very minimal fixed costs. With the M-Ray platform, we had a large production facility in Sweden that required a decent amount of staffing and also quite a lot of space and equipment. With the new testing platform, our costs are almost all variable, which really allows us to match our expenses to testing when we're performing it. So we're very excited about sort of the attributes of the next generation test. And let's talk about really the most important attribute, which is accuracy. So just as a little bit of background, we'll be talking about two terms in this presentation, sensitivity and specificity. Sensitivity is the percentage of cancer cases that are successfully detected. So if you imagine a study to test the clinical validity of a product like ours, imagine that there are 100 cancer cases and 100 non-cancer controls in that study. If a test had 60% sensitivity, that means that the test would correctly identify 60 out of the 100 cancer cases, but the other 40 cancer cases would be missed. So sensitivity is really about do you find cancer when it's present? Specificity is sort of the opposite of that. It's essentially the percentage of controls that are correctly categorized as not cancer. So imagine a test that had 80% specificity, if you gave that test to this clinical validity study, you'd see a negative result for 80 of the 100 controls, but 20 of those control cases would be incorrectly identified as cancer, and that would lead to unnecessary follow-up and imaging for that patient. So obviously, we want to have Very high numbers for both sensitivity and specificity. Looking at what's the current standard of care in the market, this is results from a meta-analysis that looked at the three imaging approaches that are used today to identify pancreatic cancer in high-risk individuals. These are the results for sensitivity and specificity in detecting stage one and two pancreatic cancer. You can see that endoscopic ultrasound has excellent sensitivity and pretty good specificity at 82%. The challenge with endoscopic ultrasound is that it's quite invasive. Patients have to be fully sedated under anesthesia And because of the risks of that procedure, it must be done in a hospital, and it must be done by a physician who is very skilled in that technique. Because the challenges of endoscopic ultrasound, or EUS, MRI and CT are often used as a substitute to try to identify early stage cancer. The challenge with MRI and CT, though, as you can see on this chart, is that about 50% of the time, it's unable to pick up that stage 1 and 2 cancer. And that's because stage 1 and 2 cancer tumors tend to be small, and they tend to hide within the pancreas. And so we need a better option than these imaging approaches, not only from an accuracy standpoint, but also from a convenience standpoint as well. So we undertook the CLARITY study to look at the sensitivity and the specificity of our next generation test, both to see its performance alone, as well as to compare its performance to CA-19-9. This was the largest clinical validation of a pancreatic cancer test ever completed in a high risk population. That's really important. Sometimes you'll see cancer detection tests tested against normal people. So essentially you're comparing people who have a specific type of cancer to healthy individuals. And when you do that, you have the risk that you overestimate how accurate your test is. We wanted to make sure that we were using control cases that were essentially the same as what they would be in the real world when the test is used. To complete this study, we leveraged our existing relationships with key opinion leaders and experts in pancreatic cancer around the world. You can see here some of the sites where we collected blood samples from. We were able to obtain 1,066 rare blood samples, and of those, 202 of them were stage one and two pancreatic cancer cases. These are really rare, samples to find. Unfortunately, the vast majority of the time, over 80% of the time, pancreatic cancer is detected at stage three and four. So it's hard to get these stage one and two pancreatic cancer samples, but we were able to do so because of the strength of our relationships with these pancreatic cancer center experts. We also leveraged our relationship with the Proceed Consortium, which is a group of institutions that's focusing on early detection in pancreatic cancer to help us get that really high number of high-risk controls at 864. And here are the results. We were very excited to show sensitivity of 78% and specificity of 94% in the CLARITY study. What that means is that for every five patients with stage 1 and 2 PDAC, we would detect cancer in four of those patients. And with a specificity of 94%, if you imagine looking at 20 individuals who would be tested, if none of them had pancreatic cancer, we would only return a false positive result one out of those 20 times. We also performed very well against CA-19-9. The immunovia test was 14 percentage points more sensitive than CA-19-9, so 78% sensitive compared to 64%. And to put that into context, what that means is that in the study, With our next-generation test, we were able to identify 28 cancer cases that were missed by CA-19-9, which is often used as a way to conduct surveillance in these high-risk individuals. And this chart really brings the data together. So on the right hand, you see that sensitivity and specificity data for the imaging approaches that we talked about earlier. On the left side of the slide, you see the accuracy for the next generation test that we saw in the clarity study. We were very, very pleased by the sensitivity. You can see here that that sensitivity significantly exceeds the sensitivity that you see with MRI and with CT. And in addition, the specificity of our test was better than the specificity of all of those imaging approaches. So this is not a head-to-head comparison, but it is a very good indication about the superior accuracy of our test. And remember, this is a simple blood test. So not only is it showing excellent accuracy, but it's much more convenient than doing imaging, and it's less costly to the patient and to the healthcare system. One of the things that we looked at was the performance of our test as a function of the age of the samples that were in the study. So I mentioned that these pancreatic cancer samples are very hard to get your hands on. And so some of the samples that we had in the study were quite old. Some of them were seven, eight, 10 years old. And so what we did was an analysis to look at what happens when you separate the samples into four groups and based on how old the samples are meaning how long ago was that blood sample collected what you can see in this chart is that the performance of the test is much much higher in those samples that are newer those samples that were collected within the last two and a half years as you get further and further out and as those samples get older the sensitivity and the specificity drop significantly. We think this is critically important and we're very excited about these results because what we know is that when we test blood samples clinically, when we launch the test, we're going to be testing those samples within a day or two days of when that blood sample was collected. So you're not going to see any degradation in the proteins that are part of our test. And as a result, if you look at the sensitivity and the specificity that we saw in this study, within those newer blood samples, you can see 83% sensitivity and 96% specificity. So even better results than what we saw overall. So just in conclusion, we were very, very pleased with the performance and the accuracy of our next generation test. We showed high sensitivity and specificity. The test was significantly more sensitive than CA99. And when we looked at those samples that were more recently collected, the ones that are much more like what we'll see when we launch the test commercially, we saw even better performance, 83% sensitivity and 96% specificity. So our two-year journey to develop the next-generation test is now complete. We will continue to do additional clinical studies, but we have transitioned from that R&D phase, and we'll talk about what's coming next in just a moment. But before we do that, let's continue the review of the fourth quarter by looking at our financial results. And for that, I'll turn it over to Karin.

Thank you. And looking at the financials, one can conclude that the company continues to live on the financial plan, bringing down OPEX, bringing down cash burn and maintaining it at a low level. OPEX for the fourth quarter amounted to 30 million Swedish kronor, which is relatively flat compared to last quarter. but an increase with 7 million compared to the fourth quarter 2023. And here one can note two trends when it comes to OPEX for the quarter. One is that headcount costs are declining, while costs for clinical studies are increasing. Cash burn for the quarter averaged just over 9 million per month, and total for the quarter was 28 million, which is in line with the guidance that we have given to the market. Looking ahead into 2025, the expectation is that we should see a monthly cash burn of around 8 to 10 million Swedish kronor, and we should continue to see OPEX shifting from R&D moreover to clinical studies, leading the way to commercialization. And then moving to the next slide. A few words on the rights issue and the warrants that were exercised now in January. As we reported in the Q3 report, the company executed a rights issue during the autumn that truly exceeded our expectations. The issue was subscribed to 91% and the company was able to raise a net of 53 million Swedish kronor. With that issue followed two series of warrants. And in January now, 2025, the first series, the TO2 warrants were exercised with the participation of 74 percent and bringing net proceeds of 37 million Swedish kronor. And it's worth noting that in both cases, participation in both the rights issue and for the TO2 warrants, participation exceeded the guaranteed level, truly demonstrating investor interest. And to move over to the next slide, summing up the quarter, the company closed the quarter with a cash balance of 25 million. delivered on the financial plan, reduced OPEX and reduced cash burn. And as I said before, what we will see now moving into 2025 is a shift in OPEX from R&D moreover to clinical studies preparing for commercialization in the second half of 2025. Also, as I mentioned before, we expect to see cash burn to be around 8 to 10 million Swedish kronor per month. That's in line with previous guidance. And as I also have mentioned before, we should, though, be prepared for some volatility between the quarters, depending on sort of timing of studies that we are conducting. with the cash balance and Q3 of 25 million, and adding to that the proceeds from the TO2 warrants that we received in January, which amounted to 37 million Swedish kronor. And in combination with a not overly aggressive estimate relating to what we think we can get in net proceeds from the TO3 warrants, which are due in April this year. The expectation from management and the board is that the company should be able to fund the need of operational capital into the second half of 2025. And with that, I'd like to hand over to Jeff again.