Hello, and welcome to our webcast today. We really are excited about the opportunity to share with you results from the recently completed Verify clinical validation study of Immunovia's next-generation test for the early detection of pancreatic cancer. I'm joined today by my colleague, Norma Palma, who is the VP of Clinical and Medical Affairs. I'm Jeff Borcherding, the CEO of Immunovia. As you may have seen last week, we released the preliminary results from the study. Essentially, we shared just the top-line results, that primary endpoint number. Today, we will review the study in much more detail. We will share data from not only the Verify study, but some interesting analyses that we are now able to do because we can combine the data from Verify with our first clinical validation study, the CLARITY study.
In addition, we'll talk a little bit about the implications of the study results, what it means for our business, and especially what it means for us going forward as we look to launch the test in the third quarter of 2025 in the United States, which will be our first market. As you think about where we are in our journey, we've hit a really critical milestone. We now have two successful clinical studies, the Verify study and the CLARITY study, fully supporting our strategic priorities. We've laid these out before, but just as a reminder, as we think about 2025, we're focused on three things: conducting the clinical studies that we need to drive the success of our test, most importantly around reimbursement. We're focused on a targeted commercial launch, and we're focused on our strategic partnerships.
As we think about the Verify study and how it contributes to each of these, it's really an important contribution. This means we now have two successful clinical validations of our test. We'll talk a little bit about what that means for securing reimbursement. As we think ahead to our commercial launch, one of the things that's really critical is that we have sufficient clinical data to give physicians confidence that they can use our test to successfully detect pancreatic cancer. We're confident that we have that with the data that you'll see today.
Finally, we talked about the fact that as we go to market, we ultimately want to have a strategic partner, someone who brings commercial resources to the effort that we can use and leverage to make sure that we're fully capitalizing on the opportunity that we have to make an impact in pancreatic cancer, to save lives, and to drive the success of our next-generation test. Prior to conducting the study, we really thought a lot about what are our business objectives with the study and what are the scientific objectives. The most important business objective was around reimbursement. In the United States, tests like ours can be reimbursed or paid for by either government payers or by private insurance companies or commercial payers.
Those companies make decisions, and those government groups make decisions about what studies or, excuse me, what tests to cover, what tests to reimburse based on clinical studies. We need to show analytical validity, clinical validity, and clinical utility. Analytical validity means, in our lab, are we measuring the proteins accurately? Clinical validity, which is what we will share today, is the accuracy of the test. How effectively can we detect cancer when it's there, and how effectively can we call accurately non-cancerous samples and say there's no cancer present there? We now have two of those clinical validation studies, and that's really important because that is what most payers require in order to reimburse for the test.
From here, we also have the opportunity then to move on to the clinical utility studies, which really help show that using the test helps physicians make better decisions, and it improves patient outcome. Other reasons from a business standpoint to do the test: we want to increase physician confidence in the test. It will also help us with our regulatory submission to FDA. As we'll discuss, we wanted to build relationships with new pancreatic cancer centers and with some researchers that we hadn't worked with before. On the scientific side, the Verify study gives us the opportunity to look at additional patient groups that we haven't studied as detailed before. Most importantly, in this case, those people with pancreatic cysts. Pancreatic cysts are fluid-filled sacs that are in the pancreas that most of the time are completely benign and harmless.
A small percentage of the time, they can grow and develop into pancreatic cancer. We had a number of those patients in this study, which allows us to analyze the performance of the next-generation test within that group, in addition to the familial and hereditary risk group that we've talked about previously. We also had some feedback from the CLARITY study that we wanted to address. Specifically, in that study, we had an imbalance or a difference in the percentage of men and women and a difference in the age of our cases and our controls. Those differences reflect real-world realities. For example, there are more women who are in high-risk surveillance programs than men.
That said, it's important from a scientific perspective to be able to control for those variables and do the study in a population that is well-balanced in terms of men and women and well-balanced in terms of the age of the cancer cases and the controls that we'll look at. Finally, from a scientific perspective, we wanted to make sure that the study design of the Verify study matched what we did in the CLARITY study so that we could combine data from the two studies and draw more robust conclusions about different subgroups that were part of those two studies. We're very excited about the results of the study and excited to share that we achieved all of these business and scientific objectives with the Verify study.
With that, I'd like to hand it over to my colleague, Norma, to share with you a little bit more about the design of the Verify study and the results that we saw.
Great. Thank you, Jeff, for the opportunity. Verify was a case-control clinical validation study that was designed to determine the accuracy of the Immunovia test in detecting early-stage pancreatic cancer from high-risk non-cancer controls, as Jeff outlined. A case-control study is one in which we had representation of both pancreatic cancer cases and non-cancer high-risk controls from each institution that participated in the trial. In Verify, we looked at a total population of 115 pancreatic cancer cases and 271 high-risk controls for a total of 385 rare blood samples that were studied. Of note, this was a smaller study than our first clinical validation study, CLARITY, where we looked at over 1,000 samples. In the first study, we had enrolled 202 cases versus 115 cases for Verify and 864 controls in contrast to the 270 controls in the current study.
As you can see, once again, we had representations from some very good quality institutions. I want to note that two sites that were not involved in the original clinical validation study, CLARITY, New York University and the University of Texas Southwestern, actually contributed the majority of the cases and control samples to the study. Next couple of slides, I'm going to go into a deep description of our case and control cohorts. In looking at the pancreatic cancer cases in Verify, 31 of the 115 or about 27% of the cases were patients that reported a family history, meaning a first or second-degree relative diagnosed with PDAC or had a genetic mutation that put them at high risk for developing pancreatic cancer, according to clinical guidelines. 16 of the 115 or about 14% of cases were reported to have pancreatic cysts.
The majority of our cases were sporadic, meaning they harbored no known family history or genetic mutation predisposing them to pancreatic cancer. This high level of sporadic cases reflects the same distribution as we saw in the CLARITY study and how this population is generally described in the literature. In the high-risk control patient population, we had 142 of 270, or 53%, of patients at high risk for pancreatic cancer due to known familial or genetic factors. Fifty-two of the 270 patients, or about 19%, were at high risk due to harboring pancreatic cysts. We also had 76 of the 270 patients, or about 28%, with both high-risk factors, meaning familial genetic factors and pancreatic cysts. As you can see, our control population comprised completely of a high-risk patient population.
Of note is that we had a robust set of 128 patients total, or about 47% of the control group harboring pancreatic cysts, which, as Jeff described, is an important high-risk population. In CLARITY, we had a substantially lower percentage of patients with pancreatic cysts than in the current study. I also want to note that most other studies in early detection tests use normal healthy controls. These samples are easier to acquire, and they lead to higher, but possibly artificial accuracy numbers. We wanted to be thoughtful about this, and we felt really strongly that a high-risk control population accurately represents our intended use population. Importantly, this is the expectation of payers and regulators who demand that the test be studied in populations where the test is being planned to be used.
The primary endpoint of the study was the sensitivity of the Immunovia test, or essentially the test's ability to detect stage I and II pancreatic cancer, in this case, 115 case samples from the overall set as compared to a target sensitivity. Specificity, or the ability of the test to correctly identify control samples as non-cancerous, in this case, the 271 control samples, was relegated to a secondary endpoint as the control group was very small and did not provide us the statistical power for this assessment. An additional secondary endpoint of the study was to determine whether the Immunovia test was better or more sensitive than CA 19-9 in detecting the 115 pancreatic cancer samples from the overall set. The Verify study achieved its primary endpoint.
The test was able to identify early-stage PDAC cases 77% of the time, higher than the predefined sensitivity target of 65%, and a difference that was statistically significant. Two common imaging tests used in screening for pancreatic cancer are MRI or magnetic resonance imaging and CT or computed tomography, which has been reported to have a specificity of approximately 50%. We chose a 15% improvement of the sensitivity, or 65%, as the target for the study. With a sensitivity of 77%, the Immunovia test was 27 percentage points higher than MRI and CT, again, very common imaging modalities used in screening. This performance that we saw in the Verify study was equivalent to the sensitivity of the test in the first clinical validation or CLARITY, despite having a smaller sample size.
Specificity of the Immunovia test, or its ability to correctly identify control samples as non-cancerous at 88%, was not significantly different from the target specificity of 90%. While still high, this performance was lower than what we saw in CLARITY, and we believe that there are a number of reasons for this. There was a significantly smaller cohort of control patients. Remember, there were 271 versus 864 that was in CLARITY. Verify controls also had a much higher percentage of patients with pancreatic cysts, which are much more challenging to diagnose. In Verify, we saw 47% of patients with pancreatic cysts in the control population versus 34% in CLARITY. We also saw a notable difference in pattern of CA 19-9 levels between the Verify and CLARITY control population. Finally, we identified some differences in site-specific performance site to site.
Overall, we felt that the specificity was really strong in light of the high-risk population we're studying and the small control sample size. In the left bars, you can see that the Immunovia test was significantly better at identifying early-stage PDAC cases at 77% sensitivity versus CA 19-9 alone at 69% sensitivity. This was an 8 percentage point difference. In the right bars, the Immunovia test performed with equivalent specificity, accurately identifying non-cancer controls at 88% specificity versus CA 19-9 alone at 89% specificity. It's important to note that CA 19-9 alone performed with less specificity in Verify versus how it performed in CLARITY, which was 95%. This mirrors an overall lower level of specificity of both the Immunovia test and CA 19-9 in Verify, and again, may be a reflection of the different control population between the two studies.
Overall, we saw an improved sensitivity that was statistically different and equivalent specificity of the Immunovia test versus CA 19-9 alone. What's important is that this was consistent with what we saw in the very first clinical validation study or CLARITY. Right now, I'll turn it back over to you, Jeff.
Thanks, Norma. To put these results in context, I think it's helpful to look at the accuracy of the Immunovia test in the context of what's done today. For people who are at high risk for pancreatic cancer, they are often in surveillance programs. In those surveillance programs, they will go in usually once a year for an imaging test. That imaging might be endoscopic ultrasound, or it might be one of the two approaches that Norma mentioned, MRI or CT. Those approaches are the best that we have at this point prior to launching a test like ours that's a simple blood test that can help identify pancreatic cancer early. There are some disadvantages of these imaging approaches. On the right-hand side of the slide here, you see data from a meta-analysis.
That's essentially a collection of many different clinical studies that have been published combined into a single analysis. We looked at what's the accuracy of the imaging approaches in those stage I and II pancreatic cancers that we're trying to find. Remember, in pancreatic cancer, everything is about finding those cancers early. We have to find them at stage I or stage II because that's when that patient can have surgery, and that's when their chances of survival increase dramatically. They're more than tenfold higher if that patient is diagnosed at stage I or at stage II. Unfortunately, with imaging, it's difficult to diagnose patients that early. You'll hear physicians talk about how pancreatic cancer often hides in the pancreas. The pancreas is an organ that's not easy to reach in general. You have these very small cancers that develop.
When they're at stage I, they're at stage II, they're not generating symptoms, and they're very difficult to see with imaging. You can see that in the data in the table on the right. The sensitivity of MRI and CT is only 50%. That means that half of the people who actually have pancreatic cancer that is stage I or stage II will go undetected with an MRI or a CT scan. The specificity is better. It's in the upper 80s or around 90%, but that sensitivity is really problematic. If you look at endoscopic ultrasound, certainly the sensitivity is much, much better. That's an approach which is much better able to detect pancreatic cancers. Unfortunately, the specificity of endoscopic ultrasound is lower at 82%. In addition, with all of these imaging approaches, you have the inconvenience factor, and in some cases, you have safety risks.
For example, if you go in for an endoscopic ultrasound, you will be put under full anesthesia, and there are risks that come along with not only the anesthesia but with the endoscopic ultrasound itself, which can sometimes lead to pancreatitis. You have these imaging approaches. The accuracy is not what any of us would like to see, and they're inconvenient, and they're costly. On the left-hand side, you see the results from the two clinical studies that we've done with our next-generation test. You've got the Verify study on the left, the CLARITY study on the right. You can see that our sensitivity in those two studies significantly exceeds what you see with MRI and with CT. From a specificity standpoint, the Verify study is very much in line with or above the specificity of those imaging approaches.
In the CLARITY study, we saw the specificity was significantly higher than what you see with the imaging approaches. We really do feel like from the standpoint of meeting the market's unmet need for better detection and more convenient detection, we really have an opportunity to do that based on the clinical results that we've seen in Verify as well as in CLARITY. We mentioned earlier that we have looked at different high-risk groups as part of the study, both in Verify as well as in CLARITY. When you think about the two studies, we've now studied this test in a very large number of patients. Over 1,400 total blood samples have been studied, more than 300 cases, and over 1,100 controls.
You can see that the overall result in these studies was 78% sensitivity, meaning we detected 78% of stage I and II pancreatic cancers, and 92% specificity, meaning that when presented with a blood sample from someone who doesn't have pancreatic cancer, we correctly call that rather than having a false positive. As you look at the rest of this table, you'll see really exciting results from different subpopulations of those who are at high risk for pancreatic cancer. Some people are at high risk because they have a family history of pancreatic cancer or because they have genetic mutations that put them at high risk. In this group of people, we've shown sensitivity of 78% and specificity of 94%. Having data that is that strong is really critical because that's going to be our first intended use population for the test.
That'll be our intended use population both as we seek reimbursement from payers as well as when we seek regulatory approval from FDA. You can see that we've got 71 cases and 922 controls supporting those accuracy figures. Those kinds of numbers are unprecedented in this space where it's very, very difficult to identify early-stage cancers, much less early-stage cancers that resulted from family history or genetic mutations. I'm also very excited to share the diabetes data from these two studies. We had 128 cases from people with diabetes who participated in one of the two studies, either Verify or CLARITY, and we compared those with 105 controls from patients who had diabetes. You can see that our sensitivity and specificity are very similar to the overall result. This is the first time that we've been able to show how does our test perform in people with diabetes.
You can see that the numbers here are still relatively small, particularly on the control side. We will be doing additional work in this group, but wanted to share this data because it's really exciting and very, very promising. Finally, Norma mentioned that we had a number of patients in this study who had pancreatic cysts. Again, those are those small fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer. This is a really challenging group to diagnose, and you'll see that when we look at some other data. Even in this group, we had sensitivity of 72% and specificity of 89%. The combination of all of this data is a really critical milestone for us. It really highlights the fact and confirms for the first time that our test is effective across a number of different high-risk groups.
That is important as you look at what is our potential. If you have been in some of our presentations before, we have shared this study which looks at the total addressable market in the United States. You can see that we have very large opportunities in new-onset diabetes, familial and hereditary, and also opportunities in pancreatitis. The IPMN group that you see listed here is essentially that pancreatic cyst group that we were just talking about. This really does open up the market for us, gives us the opportunity to capitalize on the full range of people who are at high risk for pancreatic cancer and therefore should undergo surveillance on an annual basis with a test like our next-generation test. One of the last things I wanted to share was a comparison looking at how does the test perform relative to CA 19-9.
CA 19-9 is one of the biomarkers in our test. It's also the only biomarker that in the United States is approved for use in detecting pancreatic cancer. Today, it's generally used for people who have already had pancreatic cancer when physicians want to see if that cancer is coming back. In our studies, we have consistently compared the performance of our test to CA 19-9, and we have consistently shown that the Immunovia next-generation test outperforms the accuracy of CA 19-9. The real difference is in sensitivity. You can see that data on the columns that are highlighted in the darker purple.
When you look at the overall sensitivity of our test and compare that to CA 19-9, you see not only numerically different numbers for sensitivity, but when you look at the p-values, those are those statistical measures of whether or not we can really confidently say, "This is a true difference in performance." When you see those p-values that are less than 0.01, that tells you that from a statistical perspective, we are fully confident that that performance is real, that difference is real, and that advantageous accuracy over CA 19-9 is real as well. Fortunately, the Immunovia test is able to achieve that better sensitivity without sacrificing specificity. You can see that in the overall group, our specificity is 92% compared to CA 19-9 at 93%. In the familial and genetic group, we're equivalent. In the diabetes group, we're essentially equivalent as well.
Really, the only place where you see CA 19-9 perform better from a specificity standpoint is in the cyst population. In the cyst population, again, a very difficult group to look at, you do have an interesting dynamic where you have higher sensitivity for the Immunovia test and slightly lower specificity. On the net, you still have a more accurate test in pancreatic cysts in Immunovia's test. As we think about a summary of the data that you've seen today, hopefully, you will share our excitement about the data, the fact that the Verify study was a successful study. It met its primary endpoint. We detected 77% of the cancers that were included in the study. The test specificity in Verify was 88%, which was essentially equivalent to the target and CA 19-9. It is lower than what we saw in the CLARITY study.
We think that's because of the nature of the population that was in this study. Once again, we showed superior sensitivity to CA 19-9 at equal specificity overall in this study. We showed really high performance and performance that was consistently accurate across multiple patient subgroups when we combined the data from the Verify study and the CLARITY study. You see that performance in people with family history, in people who have hereditary risk due to genetic factors. You've got that in people with pancreatic cysts and in people with diabetes. The combination of all of this data puts us in a position where we feel very good about our ability to continue to pursue reimbursement in 2025. We feel very confident about the launch of our test to targeted clinicians in the third quarter of this year.
The strong Verify results also bolster our reimbursement story, and they put us in a good position to be able to move forward with a commercial partner at some point in the future. With that, I'd like to open it up for questions and see what additional information you might like to have about either the Verify study or the combined data that we talked about today. The first question: Will the data from CLARITY help in preparing for the NIH study that specifically involves cysts? Could you comment on that since it's one of the important clinical utility studies planned this year? I'll let Norma answer that and share how we think that can impact the NIH studies.
Yeah, I think that's a great question.
I think this really does set us up for having some really great evidence on the performance of the test in this pancreatic cyst patient population that is the focus of the NIH study that is set to start in 2025. As Jeff mentioned, this is a very important high-risk patient population, which is very difficult to diagnose and really is a landscape of failures for a lot of other early detection tests. I think that we are in a really great position to get some additional strong data from this, essentially a prospective study of the pancreatic cyst patient population. Yeah.
Yeah, I think it's always helpful when you sort of do the studies in the natural order of things. It is very helpful to do a clinical validation study before you do the clinical utility study.
Part of the NIH program is a clinical validity study, but we want to make sure that even before we got to that study, we had done some work with some of our other collaborators as well. We are very excited about that. Next question: Having now those superior results from the Verify study, what is your next step in commercialization? We are working very quickly to be ready to launch the test in the third quarter. I think we've shared previously that the launch will be a targeted launch where we will work closely with high-risk surveillance centers across the United States. These are about 200 high-risk programs that really are centers of excellence for people who are at high risk. It is essentially sort of the center of the bullseye as you think about where we can go to find prospective high-risk individuals.
It also allows us to commercialize the test on our own at a very reasonable cost and in a really capital-efficient way. As we think about the next steps for commercialization, we'll continue to do additional clinical studies that will support the clinical utility of the test. We'll also do additional clinical studies that look at additional data in other groups, such as more data in pancreatic cysts, more data in diabetes. As you can imagine, there are a bunch of operational pieces that we need to put in place in order to be ready to commercialize the test.
Things like making sure that we have a very clean, easily understood report for the test, doing the systems work to make sure that we can automate as much of the process as possible so that we're really efficient when we commercialize the test and we reduce our operational costs. All of those things are happening in parallel with the clinical program, and we continue to be excited about that. This is a great question. When you talk about diabetes in the context of the Verify study, are you referring to new-onset diabetes or just diabetes in general? Do you judge that results would be different if you compare new-onset diabetes or NOD with general diabetes? Norma, do you want to answer that question?
Sure.
In the Verify study, the performance that we presented in the diabetic patient population are those that were identified as having had a diagnosis of diabetes. We haven't done an analysis of those where patients were just recently diagnosed within the last three years, which would define the new-onset diabetic patient population. To your question, it's just a diabetic diagnosis in this patient population. We're not sure whether this would translate directly, that performance in a new-onset diabetic patient population. There is some literature suggesting there is different pathophysiology for those patients. However, we have committed to doing a standalone study around this patient population of new-onset diabetes that we do hope to answer that question.
Tha t's a great question. What are your expectations to receive reimbursement for your test? Will it be fully reimbursed or to which extent?
I think our goal is to make sure that we have a robust package of clinical studies so that when we present that data to whether it's government payers or those private commercial payers that we talked about earlier, that we do get reimbursed for the test. I've been in diagnostics a long time, and I know that it's always dangerous to predict what will happen in terms of reimbursement. I also know that the critical part of getting reimbursement and the way to become confident in your ability to secure payment for the test is by having that clinical data. We now have the analytical validation data. We have the clinical validation data, and we'll be working quickly to secure the clinical utility data in order to secure reimbursement from payers. Let's see. In the CLARITY study, the test performed better on fresher samples.
Could you comment on the age of samples in the Verify study? Norma, I'll give that one to you.
Sure. Yeah, we did narrow the sample collection to those samples that were collected within five years of study start, again, recognizing the data that we had seen in CLARITY. All these samples were newly acquired within the last five years of the study start and of being assessed and analyzed. In terms of the tests performed better on the fresher samples in CLARITY, as we had described kind of the differences in the patient populations in the control population, I think this is one of the main reasons we saw overall differences in performance in the Verify study. We had a smaller sample set. We had kind of a different demographic of these patients in terms of high risk with the pancreatic cyst population.
As I mentioned, the CA 19-9 levels were very different from what we saw with CLARITY. There were, I think, a number of reasons that we suspect for an overall lower performance in this patient population. We did control for the samples that were collected within the last five years.
There are two questions here that I'll sort of answer together because I think they go together. The first question is, why did you conduct a second clinical validation study when CLARITY was successful? Related to that is, can you rule out additional clinical validation studies now with the results from both CLARITY and Verify?
The reason that we conducted that second clinical validation study after CLARITY was really primarily about reimbursement in order to make sure that when we are generating test volume, we're also generating revenue and that we can generate that revenue at the kind of price that we want to receive. It's important to get reimbursement. To get reimbursement, as I mentioned, almost all payers are going to require two clinical validation studies. That was really the driver for doing the Verify study. As to whether we would rule out additional clinical validation studies now with the results that we've seen in these two studies, I would say that we will continue to do additional clinical validation studies. What we'll do is make sure that those studies are adding to the evidence and the support for the test. What does that mean?
It might mean that we look at a different patient population. Norma mentioned one of the obvious ones, which is the new-onset diabetes population. It might be that we do additional clinical validation studies to secure additional results for groups that we've studied previously. For example, as part of the NIH program, we will do another study in cysts because that data from this study was from a relatively small group of patients in the overall scheme. We will continue to do more clinical validation studies in new populations and in populations where we want more data. I would say more of our focus will be on clinical utility. Again, the difference is clinical validation is about accuracy. Can you detect the cancers? Do you avoid those false positives? Clinical utility really looks at, does the use of the test positively impact physician decisions?
Does the use of the test lead to better outcomes for patients? Are you still on track to launch in the third quarter? Does the Verify study impact the timeline? We are very much still on track to launch in the third quarter. I would say that the Verify study sort of positively confirms that we are on track and moving forward to achieve the milestones that we've talked about. Norma, a question for you. What is the performance of the Immunovia test in those late-stage cancers? I'm assuming they mean stage three and four cancers.
Yeah, great question. As you know, we focused our two clinical validation studies on early stage, stage one, and stage two, knowing that this would have the most impact in patient outcomes due to the five-year survival rates really plummeting in late stages.
Really, our focus has been to be able to identify disease at early stage. However, based on the biology of pancreatic cancer, we're pretty confident that we'll see strong performance in stage three and four. In the pooled data between Verify and CLARITY, we saw comparable performance between stage one and stage two. We don't anticipate any kind of detriment in performance as later-stage disease for pancreatic cancer. Of note, as Jeff has mentioned, we have a number of studies planned in the coming year. One of those is to do a standalone analysis of the test performance. We have a robust biobank of stage three and stage four pancreatic cancer samples that we intend to assess with the Immunovia test. Hopefully, we'll have that data out within this year.
Norma mentioned that many studies in early detection are done in healthy controls.
One of the questions was, why doesn't Immunovia conduct these studies in healthy controls? Wouldn't it lead to better results? I think it's a fair question, but I think we are very committed to looking at the performance of this test in the patient populations where we intend it to be used. Those are those high-risk populations. Because pancreatic cancer is fairly rare, this is not a general population screening tool. This is a blood test that will be done every year for those people. There's a large number of them, nearly 2 million in the US, who are at high risk. Because of that, we want to make sure that as a company, we're studying that in the right way. Practically speaking, it's also really crucial for securing reimbursement as well as securing regulatory approval.
It's an objection that we would definitely get from both payers and from regulatory agencies if we were only looking at the tests in healthy controls. We will likely do some work in healthy controls. It's been a lower priority, but just to be able to have that data, we will likely do that work sometime in 2025. It is certainly a lower priority than some of the other things that we've talked about. You've mentioned clinical utility studies a few times. Will something be announced regarding these in the near future? Can these be done on biobank samples, or do patients need to be involved? That's a great question. We are looking at various designs for clinical utility studies. Some of those studies are already planned and have been announced.
Two studies that we will conduct in pancreatic cyst patients with the NIH are clinical utility studies. One of those studies is going to look at pancreatic cyst patients who are in active surveillance. It's going to follow them over time and see whether that surveillance can be more effective if you use a blood test like ours. The second NIH study in pancreatic cysts is going to be done in people who are going to surgery. What happens today with pancreatic cysts is that at some point, the physician may be concerned that that cyst has become cancerous. At that point, the decision has to be made. Do we go and do surgery or not? Oftentimes, that decision, once the surgery is done, turns out to be wrong.
The physician and his colleagues or her colleagues thought that it was cancer, and it turned out that it wasn't, which leads to an unnecessary surgery. The second clinical utility study will be using the blood test like ours to determine can physicians make better decisions about who to take for surgery. We'll also be looking at a couple of other clinical utility studies, and we will absolutely be announcing information about those in the coming months. A question here about finances. I think many of you know we are currently in the pricing period for the TO3 warrants that came along with the rights issue that we did last fall. The exercise period for shareholders who have those TO3 warrants begins on April 1. A question about that. How critical for your finances is full conversion of TO3?
Can you succeed with launch and scale up with funding available after TO3 is completed? If so, when do you expect to achieve cash flow positive after launch? I'll take each of those in order. TO3 is important to our finances. We have built our budget around, I would say, a reasonable level of conversion of TO3, not a full 100% conversion. We also disclosed with our last quarterly report that our expected proceeds from TO3, together with our existing cash, should be sufficient to take the company into the second half of the year and well into the third quarter. We are certainly in a position where that TO3 warrant will be part of the preparation for launch. In terms of achieving cash flow positive, that really depends on how we ultimately go to market and when we partner with one or more commercialization partners.
That would certainly happen much more quickly with the commercialization partner in place at the right time, and that's certainly our expectation. We haven't announced a specific target date for being cash flow positive at this point. Question. What is your estimate of screening volumes in high-volume centers that you are targeting? It varies quite a bit by those set by each center. There are some centers that have 500, 600, and even more patients under active surveillance for pancreatic cancer. Conversely, there are some programs that are smaller where maybe they're only following between 100 and 200. A lot of it depends on geography, but certainly, they are a great place to start because these are centers that are already doing pancreatic cancer surveillance. In many cases, they're actually struggling with capacity.
One of the things that we hear pretty consistently from key opinion leaders and from the physicians who run these programs is that they are struggling to handle the number of people who are coming to them and saying, "I'm at high risk for one reason or another. I want annual surveillance." Unfortunately, right now, the centers are struggling to keep up with that demand because of the fact that things like endoscopic ultrasound require an expert endoscopist, and they just simply do not have the capacity that they need. One of the things that we are excited about and that those physicians are excited about is having access to a blood test that would significantly increase their capacity.
I think when we see that, we're going to see programs that are even significantly larger than the 500 or 600 or 700 that you see from some of the larger programs today. I think we covered all of these if I yep. Oh, it looks like I didn't. There was one question earlier about the clinical utility studies. We talked a little bit about that, but I realized I didn't answer the second part of the question, which is, can these be done on biobank samples? It's possible, but I would say most clinical utility studies are going to be done on patients who are being seen as part of a surveillance program. The biobank samples are really useful for clinical validation. For clinical utility, we're generally going to be looking at a more traditional clinical study. Okay.
I think that takes us to the end of the questions. For those of you who have hung on through the whole session, I want to say thank you. I really appreciate your interest in Immunovia. Certainly appreciate the fact that you have put your trust in us. We continue to work hard to earn that trust. We will continue to push to achieve the milestones that we've laid out with clinical studies, with commercialization, and with a business partner that can help us to not only drive the success of our next-generation test, but can help us build the kind of business that rewards shareholders in the process. I will also thank my colleague, Norma, for her help in preparing and delivering the presentation and say thank you again for joining us. Take care and have a great day.
Thank you.