Immunovia (Stockholm:IMMNOV) Q3 2026 Earnings Call

0:00 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.

0:49 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.

1:53 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.

2:47 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.

3:49 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.

4:39 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.

5:45 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.

6:47 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.

7:36 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.

8:21 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.

9:09 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.

10:02 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.

10:47 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.

11:41 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.

13:10 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.

14:00 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.

14:49 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.

15:50 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.

16:38 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.

17:51 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.

18:58 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.

19:48 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.

20:48 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.

21:36 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.

22:49 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.

24:19 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.

25:09 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.

25:30 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.

26:22 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.

27:09 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.

27:28 Yes, we can move on to the next slide, please.

27:34 So since the last right issue that we have in 2021, The company have been investigating different potential capital injection for the company to meet the common activities that we have, the milestones that we aim to achieve in the coming period of 2027. Based on our market cap, the capital requirements that we have, especially for the next coming six months or the first half year of 2027, we concluded of the balance assessment that rate approximately 63 million before issue cost and compensation to the underwriters was the most stable with favorable option for the current shareholders, even if the result of delusion is pretty high. The proceeds from the right issue will found the operation to the second quarter of 2027, and there is potential for additional proceeds from the warrants to found the operation into the third quarter of 2027.

28:36 80% of the right issue is secured from management, board and underwriters, which means we have approximately 50 million secured at this point. Board management are committed to subscribe for shares exceeding their perata in this transaction. The proceeds from the TO4 in May could potentially generate additional proceeds of 31.7 million. Short about the structure in the right issue, each unit consists of two shares and one warrant of TO4. The subscription period for the shares is from November 9 to November 25 this year. The subscription for the warrants TO4 is from April 19 to May 3, 2027.

29:29 Thank you very much, everyone. for this update about the financials and the right issue and we hope to see as many of you participating in the right issue. Over to you Jeff.

29:44 Thanks Ben. Just a quick note about how we plan to use the capital from the rights issue to support our growth and really achieve those key milestones. It largely mirrors what you would expect based on our focus areas for 2027 and going forward. On the commercial side, this will fund targeted investment in sales and marketing to continue to show the market demand for the pancreas sure test. In terms of the clinical studies, I'll walk through some of the ones that we have ongoing in addition to those that I've already mentioned. And then as you would expect, a portion of the rights issue proceeds will be used to fund general company expenses such as operating our lab in North Carolina.

30:36 In terms of the clinical studies, I'm very excited about the studies that we have ongoing. These first two studies are actually largely funded by the NIH. Our cost is really limited to the cost of processing the pancreas sure test, but we'll be looking at pancreatic cysts and how the pancreas sure test can improve patient outcomes for those individuals that have these growths on their pancreas that can turn into cancer but don't always. And so we'll be looking at using pancreasure both in surveillance of these individuals as well as to help make better decisions about whether they should go to surgery. And then finally, we've got two studies ongoing with Kaiser Permanente, the BEACON study and the RADAR study. These are really intended to be prospective studies showing what happens when you use the Pancreasure test in clinical practice. So it's not quite as real world as Assure.

31:43 These are more controlled studies that allow us to really understand the real-life performance of the test in terms of its specificity as well as its sensitivity. And so we're excited to partner with Kaiser Permanente on these studies. If you'd like to learn more about the rights issue, we will have a page on the Immunovia site at investors.immunovia.com, or if you just go to the Immunovia website and click on the Investor tab, there you'll see a specific landing page for the rights issue. In addition, you'll also see, if you haven't seen it already, that we have revamped our shareholder page to really try to improve the communication about what's happening within you know via we want to go beyond just these quarterly reports and the press releases that we share to include more regular updates and updates that go a little bit more in depth so you'll see things like interviews with members of the in you know via management team and you'll see additional details about press releases so that you can get additional details that'll help you understand what does the news really mean, how does it impact the company, and what does it mean for Immunovia's future.

33:11 A final note on the rights issue, and Adam alluded to this, but I really want to acknowledge the fact that we realize that The rights issue is very dilutive for shareholders. I realize that that is painful. I am sorry that we have had to resort to another rights issue to fund the company in the 2027. Our goal is to fund the company in ways that are less painful going forward and it's certainly better reflect the value of the company. So we will be generating revenue and that should support some of our operations. I think a key part of what we're trying to do is generate infusions of cash through those business development activities as well.

34:02 In addition, those business development activities may allow us to identify partners who can take on certain work that we're doing today, allowing us to reduce our spend. So all of those things are challenging, and we'll be working through those challenges. But I really do appreciate the support of our shareholders and hope that we can count on your support through the rights issue as we raise the capital to achieve the upcoming milestones, both commercially as well as on the clinical study and reimbursement side. And with that, we will open it up for questions. To ask a question, you can use the Q&A feature within Teams, and we'd love to answer any questions that you've got.

35:10 I'll share one that I've heard separately from the call here, and that is, as you think about the future of immunovia, how should we think about growth? And, you know, is immunovia going to be a multiple product company? Is it going to be focused in pancreatic cancer? And I think for us, we really are focused in pancreatic cancer. We see a tremendous opportunity there. And we know that this is an area where the company is out in front. and others are either not focused on pancreatic cancer or they're playing catch-up with us. And so we see significant opportunities in pancreatic cancer, both for doing surveillance in high-risk individuals like those with family history or those with genetic mutations, but also we see an opportunity to move forward in people who are identified using artificial intelligence to say, these are people that might not fit into those traditional high-risk groups, but they are somewhere in that high-risk group.

36:24 We have a question. Congratulations on the increase in net sales. quarter over quarter is it possible to confirm whether that increase was mainly test sales as opposed to royalties and I would say we saw growth in both so in this particular quarter royalties were good but we also saw compelling growth in net sales as well obviously going forward net sales is what's really going to matter and so that's what our focus will be the question was is the revenue solely due to higher volumes, or was there any benefit from higher realized prices through those insurance payments? So I would say it was primarily due to volume increases, but we did see a benefit from the insurance payments increasing the average selling price of the test. So, we'll have more to share about that in coming quarters.

37:22 Again, as we get more data on what those commercial insurance payments look like. Right now, it's a small number of payments, but we are encouraged by what we see. Could you repeat your vision from the growth phase from 2027? What do we expect to be the main drivers of further increased sales during the coming 12 months? It's a great question. So I think there are a few things that I would point to. The first is that there is a natural momentum to our commercial efforts. And what I mean by that is as we are bringing more and more centers on, we have the opportunity to take them from the trial phase to the adoption phase. And that leads to a meaningful increase in volume. The second thing that I would point to is that our systems are set up to allow physicians and their staff to place future orders. And what that means is that maybe a patient comes in and they're getting an MRI for high-risk surveillance.

38:42 But the physician wants to do a pancreasure test in six months. So that physician, while the patient is in their office, will say, oh, I'm going to put an order in for pancreasure in six months. So that is a potential source of volume that we don't recognize in our results today, but is growing and offering the potential for growth in the future. And then the last thing that I would point to is As we think about the revenue, I just mentioned that we do see an opportunity potentially to have an increase in our average selling price per test. We'll have to see how that data plays out, but we think that that can be a viable opportunity. Those are the three growth drivers kind of within the overall Immunovia company, but the biggest growth driver will be if we can get a partner on board to help us either sell the test in the United States or in the longer term in China and Japan.

39:51 A question, can you elaborate on what we see as the main takeaways from here for future positioning of pancreature? So, just as a reminder, here was the study that we did among high-risk individuals. About half of them were enrolled in a surveillance program today. The other half were not in high risk surveillance, even though they are in fact high risk and have been told by their physician that they're at a high risk for pancreatic cancer. I am very excited to share in coming quarters the data from this study. We didn't share a lot today because we are sharing that meeting or sharing that data at upcoming scientific meetings. We have to keep it confidential until we do that. But just to give you a broad sense, a couple of key takeaways. Number one, very, very high interest in using a blood test for high-risk surveillance.

40:52 It confirms what I think we all would believe, which is people are very interested in a simple, convenient blood test. The second thing is that for those individuals who are already on imaging and are doing that on a regular basis, they have a strong desire to add the pancreas sure test on top of that imaging. I think that's really good. We've worked under that assumption. but it's good to be able to share data with physicians to say, even if someone is being monitored with imaging today, that patient would likely be interested in the extra security that's provided by a pancreasure test. And then for those who are not on surveillance today, what we see is that they view the pancreas sure test as a good entry point for high risk surveillance, essentially a way to get started.

41:47 We saw a number of qualitative comments about you know I'm not ready to do endoscopic ultrasounds every year I'm still a young person but I wouldn't mind doing a blood test every year as the first step to getting into pancreatic cancer surveillance so I think it gives us really good opportunities to leverage that data once we share it at these scientific meetings once we get it published we'll incorporate that data into our selling messages with physicians This question, what is the sales budget for Q4 2026? You know, at this point, we don't give sales guidance. And the reason for that is that because we're at this early stage of our commercialization efforts, forecasting volume is challenging.

42:40 And I would say forecasting the payments from insurance companies is much, much more challenging. We have very limited data there. So we don't give sales forecasts for 2026. but I will say I'm very encouraged by the trajectory that we see. Question about the Medicare request. Since it was submitted on September 28th, what are the next milestones AB AB AB AB AB one of the things that may happen during this process is a contractor advisory committee and essentially that is a meeting where the group brings together experts in the field that could be physicians and it could also be advocacy groups or even high-risk individuals themselves where they bring those individuals together to ask for guidance about the test and its role in treating patients the You know, one of the things I'm very excited about with the Moldex review process is that we had four different patient advocacy groups that announced their support for

44:13 pancreasure getting coverage. And so we'll share information about that, I believe, tomorrow. But just as a preview, that is an exciting development for us, and it really shows the level of interest in the pancreasure test. One of the other things that we'll be doing as the Medicare review plays out is that we will be sharing additional data with this review group. We can continue to share data with them while their review is underway, and that allows us to take some of the results from these clinical studies that I mentioned, and when they are complete, share that data with Moldex so that it can influence their review of our submission package.

45:03 One question here is about FDA approval and the downsides of not having FDA approval. And the reality is at this point, we are sort of regulated as a lab developed test by the government. that is a very, very viable option and a well-accepted way to bring a test like ours into the US market. We do not need FDA clearance. We will try to get FDA clearance because it does provide some benefits with certain commercial payers, and I think it can help facilitate the reimbursement process in certain states.

45:48 So we will pursue that. With the clinical studies that I mentioned, we now have the roadmap laid out to go back to FDA and share with them to say, here's the data that we will have and confirm that that will meet their needs. And we expect to do that early in 2027 that we will go and talk to FDA again to get their guidance and, again, really kind of lay out those plans.

46:20 Just check and see if there are other questions.

46:34 Okay, I think that's it. So if there are no other questions, we'll go ahead and wrap there. I will, again, say that if you have questions about the rights issue, please visit the investor page on immunovia.com. AB AB AB AB can participate in the rights issue. So please check that out and let us know if you have questions. But thank you very much for your time. We really appreciate it. I am incredibly excited about the future of Immunovia as the pancreatic test really starts to accelerate in its momentum.

47:27 And we hope that we can raise the capital that we need to keep this momentum going and to really make the impact that we want in early detection of pancreatic cancer and to reward shareholders who have obviously been through quite a journey with the company. And I hope that that journey leads to a lot of success here as we move through 2027. So thank you very much for your time. Take care.