Immunovia AB

Ladies and gentlemen, welcome to the Immunovia Q2 Interim Report 2025 conference call. I am Moira, the Chorus Call Operator. I would like to remind you that all participants will be in listen-only mode and the conference has been 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 Jeff Borcharding, CEO. Please go ahead.

Welcome to the Q2 2025 interim report for Immunovia. Thanks very much for joining us. I am Jeff Borcharding, the CEO of Immunovia, and today I'm also joined by Adam Beckstrom of ProRata. We engaged ProRata earlier this year to manage accounting, financial reporting, and provide CFO advisory services to Immunovia. Adam and his team provide deep expertise, and they have been terrific partners, providing us with excellent services at a much lower cost to the company compared to when we were employing a CFO and accounting team. So we're very pleased to be working with Adam and the ProRata team and excited to have him joining us today. Thank you. Yes. We've spoken often about Immunovia's mission. This mission drives the work that we do every day to increase pancreatic cancer survival through early detection in high-risk individuals. Today's call is especially important as we think about this mission because we've never been closer to achieving that mission. We are taking a significant step forward as we progress through this journey to making an impact in pancreatic cancer. The launch of the Pancreature Test next week is a key milestone in this journey, and we're excited to share information about that launch with you today. Before we do that, we'll hit key highlights from the second quarter of 2025 and review our Q2 financial results. We'll also discuss the shareholder rights issue that we announced late yesterday, why we are doing that rights issue and how we will use the funds from that investment. Finally, we'll spend most of our time discussing the Pancreasure test launch and what lies ahead for Immunovia and for our test. But first, as we look back and reflect on the second quarter, One of the critical things that happened in this quarter was essentially the scientific community taking notice of the clinical data and the work that we've been doing on the pancreas share test and really celebrating and embracing that work and highlighting that work for physicians that are in this space. In the second quarter, we had the Digestive Disease Week meeting. This is the largest gastroenterology conference in the world. At that conference, one of the primary investigators from our clarity study presented the results from that study to the participants at that meeting. We were very excited that that presentation was highlighted as best of DDW, which recognizes the most important presentations from the meeting based on the clinical impact and the importance of those studies as well as the scientific rigor. We think that's an incredible endorsement of the quality of the science that backs the pancreas sure test. Similarly, at a meeting of the Academy of Diagnostics and Laboratory Medicine, we were very pleased that our analytical validation study was selected to receive a prestigious award called the Distinguished Abstract Award. Only about 2% of the abstracts that are submitted to the conference are selected for this award. And we really think that it highlights the fact that when we did the analytical validation of the pancreas sure test, when we were looking at the precision of the test, how robust the test is, how stable the test is, We got excellent results, and those results were recognized with this prestigious award. In addition to moving things forward on the science front and sharing and disseminating data about our studies, we also made important progress toward securing payer reimbursement in the second quarter. As I've shared previously, the road to reimbursement is an extensive process, and there are a number of steps along the way. To secure payment for a diagnostic test, there are three overall key steps, securing a code, securing a cost, and securing coverage. A code essentially means that you are assigned a numeric code for the test that enables you to seek payment from payers. When we talk about cost, what we really mean is what's the price of the test that will be reimbursed by Medicare, which is the government payer for people over 65 in the U.S., as well as by private insurers in the U.S.? And then finally, the third component is coverage. This is the place where those insurance companies and government payers make the determination that the test that we have is medically necessary, that it's an important test that should be offered to patients, and that the government or that payer is willing to reimburse us for the test. So each of these needs to come together in order for us to get reimbursement. So what happened in the second quarter? Well, importantly, we were able to secure a code from the American Medical Association. This code will become effective October 1st, and it means that after that we will be able to submit claims to insurance companies. Again, that's only a first step, but it's an important step. For the cost, we have made a proposal to Medicare for what the cost of our test should be. What should that reimbursement rate be? that appears on a national fee schedule called the clinical lab fee schedule. The price that's reflected there is really important for two reasons. First, that's the price that's used by Medicare to reimburse tests. The second is that that number largely becomes a reference price that other payers use in setting the price that they'll reimburse the Pancreasure test for. So we've made a recommendation to Medicare. What we recommended to Medicare is that the test of the Pancreasure test should mirror the price that they previously had awarded for the Imre Pancandee test, our first-generation test. That would put the price of the test at $897. a process by which others can recommend a price for the test as well. There is another group, the committee, that recommended a price of $760. So we're now in the process of working with Medicare to determine which of those two recommendations will be adopted. Regardless, we feel good about the outcome of that process, and we feel like we'll have an attractive price for Pancreasure. Finally, on the coverage side, we have designed two clinical studies that we'll be conducting in the fourth quarter of this year as well as in early 2026 to demonstrate clinical utility. Clinical utility basically means that the test has value for physicians, they use it in their decision making, and it has value for patients because it helps them have better outcomes. So overall, a quarter of strong progress on the reimbursement front. With that, let me hand it over to Adam to review our Q2 financial results.

Thank you, Jeff. So a little bit, as Jeff said in the beginning, one important word has been that we need to find more cost-efficient way to operate our operation and one thing that we have been looking into new solution in IT and other overhead expenses that we have been able to reduce in the last period. As you can see our operating expenses during the second quarter were around 20 million SEK which is 17% lower compared to the same period last year. Another thing that has been very important now when we look into the into the different kind of cost saving is that we still want to accelerate the work with the commercialization, which means that we need to focus and allocate our expenses on the right things. When we're looking at our cash balance in the end of the second quarter, we have roughly 29 million SEK, which is a little bit better than we had predicted from the beginning. Our cash burn had been lower during the second quarter, by the cash burn has been around 6 million per month, and our projections was 8 to 10 million. These 8 to 10 million that we have in projections are still in line and is what we are expecting to have until we reach the commercial phase.