Good morning and good afternoon to those of you in Europe. We're very pleased to be with you today to talk more about Immunovia's next-generation test and its performance in the recent clinical validation study, CLARITY, that we completed. I'm joined today by a fantastic group of presenters that I'm very excited for you to hear from. I have two of my colleagues from Immunovia, Norma Palma, who is our VP of Clinical and Medical Affairs, who has been leading much of the study design and execution work for the clinical program on the next-generation test. We also have Lisa Ford, who came on board this summer as our clinical lab director. Lisa runs the lab in the U.S., in North Carolina, and she has been the one whose team has been executing the study and bringing the expertise that she has in developing tests to Immunovia.
Finally, we'll be joined by Aimee Lucas. Dr. Aimee Lucas is the Chief of Gastroenterology and Hepatology at Mount Sinai in New York City. She's also a professor of medicine at the Icahn School of Medicine. Aimee is a member of our scientific advisory board, and she has been an integral part of the clinical program as we have been developing and testing our next-generation tests. And I'm very excited for her to join us this morning. She is just wrapping up some work at the hospital, and so she will be joining us shortly. While we're waiting for Aimee, I'd like to give a little bit of background about why this work is so important and really set the stage for how we think about our test and what it needs to accomplish in order to meet the need in pancreatic cancer.
Some of you have probably seen this slide before. It talks about that unmet need. And in essence, it comes down to this: pancreatic cancer is an absolutely lethal and deadly cancer. Despite the fact that it is fairly rare, it is the number three cause of death by cancer in both Europe and in the U.S. And the reason is that the five-year survival rate is so low, just 13%. The survival rate is so low because pancreatic cancer often doesn't show symptoms until it's too late. You can see this on the right side of the screen, where one in four patients is diagnosed early when surgery is still an option. Those patients have more than a tenfold chance of surviving five years compared to those patients who are diagnosed too late. So we really need better tools for early detection.
We really need better tools to make it easier for patients and high-risk individuals to get tested each year so that we know that they are cancer-free, and if they do have cancer, we can catch it early when surgery is still an option and the outcomes are much more likely to be favorable. I want to quickly, before I hand it over to Dr. Lucas, just talk quickly about a couple of terms that you'll hear us use quite a bit on today's call. Those terms are sensitivity and specificity. Those are really the two key measures of success for an early detection test like ours. Sensitivity refers to the percentage of cancer cases that are successfully detected. Specificity means the percentage of controls, those patients and those blood samples that do not have cancer that are correctly classified as non-cancerous.
You can imagine a clinical validity study similar to the one that we are going to share today. Imagine that this study has 200 total samples. Of those, 100 of the blood samples are from people who have cancer. The other 100 samples are from what we would call controls. These are high-risk individuals who do not have cancer and essentially want to know, can the test distinguish between these two groups accurately? At the bottom of the slide, you can see how we measure sensitivity and specificity. A test with 60% sensitivity would mean that the test would be positive. We would see a positive result from the test in 60 out of the 100 cancer cases. That would also mean that the other 40 cancer cases would not be detected. That's sensitivity. Specificity is sort of the opposite end of the spectrum.
We want to make sure that not only are we detecting cancer, but that we're not giving false signals when cancer is not there. That's specificity. And so specificity of 80% means that if you had those 100 control samples, you would return a negative result, 80 of those 100 controls, and the other 20 controls would be incorrectly classified as positive for cancer. And usually what that means is that that patient would then undergo additional diagnostic workup to see the fact that they do not have cancer. So these terms are important. Wanted to make sure that we shared them with you before the call. What I'd like to do now is hand it over to Dr. Aimee Lucas, who is an expert in this field of early detection of pancreatic cancer.
She oversees the Pancreatic Cancer Early Detection Program in high-risk individuals at Mount Sinai and just has a tremendous amount of information on this topic. So I will hand it over to Dr. Aimee Lucas, who will talk with us a little bit about the standard of care in pancreatic cancer surveillance today.
Thanks so much, Jeff. It's a pleasure to be here. One of the things I wanted to make sure we mention is that screening for pancreatic cancer and what we call the average risk population is actually not recommended at this time in the United States and in most countries due to inadequate test characteristics of the current screening and surveillance techniques. However, we do recommend surveillance or screening for pancreatic cancer for certain individuals who exceed, at least right now, a threshold of around 5% lifetime risk. These are typically thought of as individuals who have a strong family history of pancreatic cancer, so multiple family members with pancreatic cancer, or those who harbor pathogenic germline variants in pancreatic cancer susceptibility genes. So these might include genes that you may have heard of, such as BRCA2 or ATM, which predispose to a number of cancers, including pancreatic cancer.
The current standard of care in pancreatic cancer surveillance is imaging. These imaging techniques have both mixed performance for early detection and some challenges. I'll go through them one by one. The first technique is something called endoscopic ultrasound. This is actually an endoscopy procedure whereby, under anesthesia, a gastroenterologist will place a camera down the throat into the esophagus and into the stomach and first part of the small intestine. That camera actually has an ultrasound probe at the tip of it. From the lining of the stomach or the small intestine, the endoscopist can actually see into the pancreas and even sample any abnormalities that might be there. This is an intensive procedure. It requires patients to typically take a day off of work.
In the United States, we also have a requirement that a friend or a family member come pick somebody up after anesthesia. So this means two individuals are typically out of work for the day, and you do undergo anesthesia. The sensitivity of endoscopic ultrasound for detecting stage one and two pancreatic cancer is actually very high, approaching 100%. However, endoscopic ultrasound has a specificity, meaning just specific for pancreatic cancer, of only around 80%, meaning around 20% of the time we'll find things on endoscopic ultrasound that actually are not pancreatic cancer, but we'll have some type of positive test result. And so you can understand that this causes significant anxiety within some of our patients. Another test that we use is MRI or magnetic resonance imaging. This is an imaging test only, so it doesn't have the capability to do diagnostics such as biopsy at the same time.
So if we find something, we have to follow that up with another test, which typically is endoscopic ultrasound. It's a magnet, so there's no radiation included in the exam. But one of the challenges is that it's very expensive, and patients have to go into a small tube for a prolonged period of time, stay very still to acquire the appropriate images, and then also undergo a number of complex breath holds throughout that time. So some of our patients have real challenges with MRI for pancreas visualization because of claustrophobia or otherwise inability to tolerate being in this relatively small tube for some time, up to about 30 or 40 minutes. The sensitivity of MRI is also quite decreased compared to some of the other imaging tests.
And so you see here that the sensitivity for MRI for detecting early stage one and two pancreatic cancers is actually around 50%. So approximately half of those who have these earliest stage cancers will not have a positive test result based on MRI. And that's a real challenge for us. The specificity for MRI is high, above 91%. And there's a third imaging test which can visualize the pancreas, but is not typically recommended for pancreatic cancer surveillance, and that is a CT scan. CT scans, again, are imaging tests only, so no possibility of having a biopsy. It's a faster test than the MRI, but it does include radiation. And so this is something we do not favor in some of our patients who are at increased risk of developing pancreatic cancer because we want to avoid additional radiation exposure.
The sensitivity of CT scan for early pancreatic cancers is, again, suboptimal, with specificity that is improved, but not quite at the point of MRI. So these are some of the challenges associated with standard of care in pancreatic cancer surveillance for high-risk individuals in the current state. I think I'll hand it back to Jeff at this point.
Thanks, Aimee. So given that background, this is the key information that I think is helpful to understand. Why is it that there's such a need for a blood test to detect pancreatic cancer at stage one and two? We need a blood test that's accurate, meaning that it has good sensitivity and good specificity. We need to deliver that accuracy in a simpler, more convenient way so that people can take a simple blood test in order to be tested instead of having to undergo that annual imaging or in addition to undergoing that annual imaging, just in case that MRI, for example, has missed a pancreatic cancer, that there's another opportunity to catch that cancer with a blood test like our next-generation test. Some of you have seen this slide before. It essentially shares the process that we have gone through to develop our next-generation test.
This was a very disciplined, structured process. And while we moved through it very quickly, we moved through it very, very carefully and with quite a bit of discipline. It started by identifying proteins that are capable of detecting pancreatic cancer in the discovery stage. From there, we narrowed the list of protein biomarkers that we would incorporate into our test. We defined that test algorithm, and we showed high accuracy in that model development study of 623 patients. From there, we moved into the, excuse me, the analytical validation stage. And I'm going to turn it over in just a second to Lisa, who will talk more about that. And then finally, we'll spend the bulk of our time today talking about the clinical validation, where we showed the sensitivity and specificity of the test. And that's where Norma will really cover the information about that study.
And with that, let me hand it over to our lab director, Aimee, or I'm sorry, our lab director, Lisa, to talk about the analytical validation.
Thank you, Jeff. In the analytical validation, the performance of the assays used to measure each biomarker was fully characterized with a goal of showing that we can accurately, consistently, and precisely measure each protein biomarker over time. The validation is conducted according to strict regulatory guidance. Many experiments were performed, but I'd like to highlight the most important. In the analytical validation, we showed that the measurement of the protein biomarkers matched with the model development study and that we could measure the biomarkers in serum with excellent precision, even compared to the most stringent acceptance criteria. Because of this, we knew that we were introducing as little bias as possible into the measurement system. We also confirmed that laboratory conditions commonly encountered during analysis of samples would not affect the measurement of the biomarkers. The conditions tested included interference from common substances and different temperature conditions.
This shows that the method is rugged and repeatable. The quality control samples used to show accuracy and precision in the analytical validation were also measured in every batch of the clinical validation study to ensure ongoing method performance consistent with the validation. The assays achieved even better precision than the clinical validation study and exhibited no drift in accuracy over the course of the study.
Excellent. So essentially, with the analytical validation, we're looking at those individual measurements of the specific protein biomarkers that make up the next-generation test. The next question is, when we combine all of those measurements together, can we accurately predict pancreatic cancer and distinguish pancreatic cancer from non-cancerous control samples? And so for that, we did the clinical validation, and I'll hand it over to Norma to talk through that study.
Great. Thank you, Jeff, so the CLARITI study, as we call it, was designed to validate the performance of the Immunovia test in differentiating pancreatic cancer patient samples from non-cancer high-risk control patient samples in a population that was independent from the model development study, which we had previously reported on, and so we know that the clinical validation studies, you'll expect to see a reduction in accuracy from the model development study results since the test algorithm is directly developed in that model development sample set, so our primary goal here for the study was really to determine the accuracy of the test against pre-specified performance targets of greater than 65% sensitivity and greater than 90% specificity. We also wanted to look at the accuracy of the test versus CA 19-9, so CA 19-9, if you're not familiar, is a biomarker that's currently used in pancreatic cancer post-treatment.
It's really to monitor return of disease. It is sometimes used, but not approved for diagnosis, as it is neither sensitive nor specific enough for disease detection. What I did want to highlight about this study is that it serves as the largest biomarker test validation study where patients at high risk for pancreatic cancer are used as controls, which is our intended use population for our test. Generally, what you'll see in biomarker test studies are the use of normal healthy controls. Generally, using normal healthy controls really tends to skew results to better performance due to a less challenging patient population for testing. Next slide. For the CLARITI study, we collected over 1,000 blood samples from top pancreatic cancer centers in partnership with some of the most esteemed experts in the field.
An important collaboration was with the Pancreatic Cancer Early Detection Consortium, or PRECEDE, really, which is an international cooperative group of over 50 leading academic medical centers across the globe. This group is focused on transforming the early detection and prevention of pancreatic cancer. With this close collaboration with PRECEDE, we were provided access to over 400 rare patient samples, highlighting the group's confidence in Immunovia and in the study in particular. As you can see in the slide, we were able to collect over 200 stage one and stage two pancreatic cancer cases and over 800 non-cancer high-risk controls. Next slide. The results of the study show that the Immunovia test performed with 78% sensitivity and 94% specificity in detecting pancreatic cancer cases from high-risk non-cancer controls.
So that means that the 78% sensitivity translates into the ability of the test to accurately detect early stage pancreatic cancer in four out of every five patients with cancer, while the 94% specificity indicates that we would generate only one false positive with our test for every 20 patients tested who did not have the disease. And this goes along with what Jeff had described in terms of what the meaning of sensitivity and specificity previously. Next slide. So in comparison to CA 19-9, the Immunovia test was significantly more sensitive, at 14 percentage points higher than CA 19-9's 64% sensitivity. This means that the Immunovia test was able to identify 28 cancers that were essentially undetectable by CA 19-9 alone. Next slide.
So in comparison across studies, so this was not a head-to-head study, you can see that Immunovia test, while less sensitive, is much more specific than endoscopic ultrasound, which is considered the standard of care for detection of early stage pancreatic cancer. Additionally, the test is more sensitive and more specific than both MRI, which is also considered a standard of care, and CT imaging modalities. In thinking about the comparison of a blood biomarker test versus the challenges of the imaging techniques, as was very nicely outlined by Dr. Lucas, there's an obvious benefit of the convenience, the non-invasiveness, and ultimately the cost of savings of the Immunovia test. A common phenomenon in studies where proteins are investigated is the impact of sample age. We know that as age of samples increase, they could become more problematic to work with, even at optimal storage environments.
This is often due to protein degradation and other biochemical changes that happen naturally. As I mentioned, these are extremely rare patient samples and are often housed in biorepositories for long-term use in multiple studies. While we're continuing to analyze the data from this study, what was apparent was that the test showed significantly better performance in samples that were collected more recently. Here, we've broken out test performance as a factor of age of sample in increments of 2.5 years and show a significant increase in test performance in samples collected within the last five years. Samples acquired within the last two and a half years show the overall best performance with an accuracy of 83% sensitivity and a specificity of 96%. This is significant because we know that in clinical practice, our patient samples would be tested within days of collection.
So performance in real world, we would think would be as good or better than this. Next slide. Sorry. So in summary, the primary goal of the CLARITI study was achieved with the Immunovia next-generation test showing high sensitivity of 78% and high specificity of 94% in detecting stage one and stage two pancreatic cancers from non-cancer high-risk controls. The test was significantly more sensitive than a current biomarker used in pancreatic cancer, CA 19-9. It was also clear that age of sample was a factor in the test performance, especially in samples greater than five years of age, and that patient samples collected within the last two and a half years had much better accuracy at 83% sensitivity and 96% specificity.
So this performance is comparable to the results we reported on in the model development study and, more importantly, really reflects real-world clinical testing, which would involve samples tested within days of collection. And I'll hand it back over to Jeff. Jeff, you're on mute, Jeff.
Thanks, Norma. I was coughing earlier and didn't want to disturb the event. So one of the things that was really fortunate was that we were able to announce these results last Monday when Norma and I were at the American Pancreatic Association conference. That gave us a really good opportunity to interact with a large number of experts in pancreatic cancer to get their feedback on these results, to share the results, and understand how they would think about these results. You can see some of the quotes from those individuals here. They talked about the impressive results, talked about them as being important because it beat CA 19-9 consistently.
And I think in some ways, probably what was even more important to me as an indicator of their support was the fact that we had two different groups who have a sample set of really rare pancreatic cancer samples.
These are individuals who have been keeping a really diligent effort in place for years in order to be able to collect these samples, to be able to test them with early detection tests like ours. So they hold those samples very close. They consider them to be very precious, and they only want to use them for studies where they really believe in the performance of the test. And so we have been talking with one of these individuals in Europe. And when she saw the results, she said, "These are great. These are absolutely the kind of results that we want to see. Let's move forward with the study that we've been talking about." We also had a very similar experience with a large institution in the U.S. as well based on the results.
So I think that speaks to how individual clinicians are viewing the results, but really wanted to give a chance to bring Dr. Lucas back into the call so that we can talk with her about her impressions of the results. So, Aimee, maybe I'll start there. When you saw the results, what were your initial thoughts?
I was really excited. I think for us in the pancreatic cancer surveillance world, our current testing is the best that we have, but it's not entirely adequate, partly because of some of the issues that we discussed earlier, but partly the imaging test characteristics, but the overall burden on some of our patients is actually quite significant when you have to think about undergoing some of these tests on an annual basis, the expense, at least in the United States, that patients undertake in undergoing some of these surveillance examinations, and seeing a sensitivity in the high 70s and 80% is really important for pancreatic cancer surveillance, and particularly looking at the specificity test characteristics. I think they're incredibly exciting.
I was very happy to see that the performance didn't deviate significantly from the model development study, but some of those changes were expected, as you and Norma described earlier.
Yeah. Aimee, you talked about the burden of surveillance. Can you talk a little bit more about that?
Sure. So we recommend surveillance on an annual basis, at least as of right now, which typically starts around the age of 50, and our program usually alternates between endoscopic ultrasound and MRI on that annual basis, but if there are any false positive tests or concerning findings along the way, some patients end up having repeat imaging, typically endoscopic ultrasound, perhaps three months or even six months later, so apart from undergoing the tests themselves, the challenges with getting an MRI scheduled, getting to that exam, getting through the exam, getting an endoscopic ultrasound scheduled, having somebody pick you up, any out-of-pocket costs that go along with it, there's also significant anxiety that happens for a lot of the patients, and these false positive test results, I think we can't really overestimate the impact of having false positive tests, particularly endoscopic ultrasound, for some of these patients.
The burden is really significant. When I start to talk to my patients about embarking on a surveillance journey, and let's say they're 50 years old with a father who passed from pancreatic cancer at 65 or 70, and your father's sister also passed from pancreatic cancer around 60 or 65, we talk about doing annual surveillance starting around the age of 50 and continuing until maybe 80. That's 30 years of annual imaging. It's not insignificant when we think about what our patients are going through and what we're asking of them.
You talked about that anxiety that can be caused by a false positive result. Can you talk about the specificity that we saw in the CLARITI study with the Immunovia next-generation test and how you think about that specificity number in the context of that anxiety?
Yeah. So with any blood tests, we would have to follow that up relatively quickly with another test. And here, at least in my mind, I would think about doing an endoscopic ultrasound as that follow-up examination. And so if we have a specificity in the area that we saw for the CLARITI study and we're able to follow that up with an endoscopic ultrasound shortly thereafter, we have that very high sensitivity for early stage pancreatic cancer in that endoscopic ultrasound. And we're learning more about some of the test characteristics that might make us a little bit less concerned in this particular patient population on visualization of endoscopic ultrasound.
So, for example, if I saw somebody who had a positive test result on an Immunovia test and we're able to follow that up very quickly with an endoscopic ultrasound, and if I didn't see a mass or an early stage pancreatic cancer on the endoscopic ultrasound, I would actually feel quite comfortable in telling this patient they can resume their usual surveillance.
Excellent. One of the things I think is hard is to think about what level of accuracy is acceptable, and I wonder if you have benchmarks in other areas of your practice in terms of how this accuracy might compare to other cancer detection tests that are approved by FDA in the U.S.?
Sure. I think in an ideal world, every test would be perfect with 100% sensitivity and 100% specificity. But the reality is no test in medicine is perfect. Even the routine blood tests that we have taken have challenges along the way. And I think that's something that we as clinicians understand, but we're not great at sort of sharing that with many of our patients, right? If we recommend a test, we recommend that test, and we don't always go through those nuances of sensitivity and specificity and this deep dive that we've done today. But by training, I'm a gastroenterologist, and my practice really focuses largely on pancreatic cancer surveillance, but also screening and surveillance for any number of gastrointestinal cancers. So I perform colonoscopy, which gastroenterologists, at least in the United States, consider the gold standard for screening for colon cancer.
But you might have heard, Jeff, that the FDA recently approved a blood test for screening for colon cancer. And so this is a sort of challenging discussion that we now have to have with some of our patients because the standards that the FDA set prior to the study to allow for approval of this blood test for screening for colon cancer were actually sort of surprising to many of us in the gastroenterology community. So the FDA actually said that for a blood test to be approved for colon cancer, the sensitivity had to be actually in the low 70s, so around 74%, with a specificity that approached 90%.
And so when the study came out, I believe in March of this year, for colon cancer, blood tests for screening, they actually showed a sensitivity in the low 80%, which met that benchmark, and the specificity of around 89.6%. What was disappointing for us as gastroenterologists is that we think of colon cancer screening as both early detection and prevention, and whereas most screening tests for colon cancer that are not colonoscopy and remain non-invasive are stool-based tests, colonoscopy can detect a polyp, which we can remove and then prevent cancer from developing down the road. And the polyps that we care about the most are what we call advanced adenomas, and those are the ones that are sort of on the verge of turning into cancer. Colonoscopy is very good at that.
Stool-based testing is actually reasonably good at that, but the blood test actually only showed sensitivity of around 13% for advanced adenomas. So one of the challenges we have is sort of describing how we put these screening tests into the context of sort of broader screening tests where they have different sensitivities and specificities along the way. But the blood test that the FDA approved for colon cancer screening was actually a little bit lower than some of us actually had anticipated in terms of the sensitivity and specificity.
And then maybe one final question. As you think about the results and the performance that you see with the Immunovia next-generation test, how would you envision using a test like that in your practice?
Yeah. So I think there are several ways that I could think about using the Immunovia test. Right now, our standard of care is imaging, and it's that endoscopic ultrasound and MRI for the folks who are at the highest risk of developing pancreatic cancer, right? So these are the people, the families that I just described with multiple family members in close blood relation. But expanding beyond that definition, let's say somebody had a parent with pancreatic cancer, but also multiple cousins on that parent's side of the family. That doesn't quite meet that strictest definition that we have, and sometimes they might not be a candidate for surveillance, but you feel as if there are more cancers in that family than there should be.
And so that may be somebody where we can use a test like the Immunovia test or a blood test to sort of expand that definition of individuals who are at increased risk to be able to provide an opportunity for surveillance for more individuals. One of the challenges that we have, even in this high-risk population, is interval cancers. And that's a cancer that actually develops in between those annual imaging tests. And we don't know if that's because the cancer itself actually developed in between those two interval tests, those two annual tests, or if the cancer was actually there, but because, let's say, the sensitivity of MRI for stage one cancer was 50%, maybe the cancer was already there, but we weren't actually able to detect it on that imaging test.
One way to think about this challenge is, do we use a blood test as an adjunct to our current imaging techniques? Could we use a blood test six months after an imaging test to be able to reassure our patient that they can continue to that annual surveillance? Could we use a blood test in lieu of one of those annual surveillance so that maybe we can prolong the interval to two years or even three years in between examinations, but use a shorter interval blood test with appropriate test characteristics, either every six or 12 months in between to be able to better understand what's happening in some of our patients?
And then I think I talked about expanding the population under surveillance to still sort of high-risk patients that don't meet our current criteria for familial pancreatic cancer, but still seem to very clearly be at increased risk of pancreatic cancer. I think there are other populations that will have to really start to understand who very clearly have increased risk of pancreatic cancer, who might not be in this initial study. So one of those populations are actually pancreatic cyst patients. We know that cysts in the pancreas are very common, but some proportion of those cysts actually go on to degrade into a neoplasm or cancer. We know that our patients who have chronic pancreatitis for a variety of reasons are also at increased risk of pancreatic cancer. So it'll be important to understand how we can use this test in those patients.
Then there are also patients with new-onset diabetes. So at least here in the United States, adult-onset diabetes is very, very common. We typically think of that as related to carrying a bit of extra weight, metabolic factors like cholesterol, and peripheral insulin resistance. A certain proportion, and it's a small proportion, of new diagnoses of adult-onset pancreatic cancer actually seem - or sorry, new-onset adult-onset diabetes are actually related to a new diagnosis of pancreatic cancer, particularly within a window of about two to three years after that diabetes diagnosis. What we think is that that means that the cancer was actually there because we see in patients who develop pancreatic cancer this new elevation in hemoglobin A1C or elevated fasting glucose, which is a marker of prediabetes.
And so in those patients, in some patients who are developing diabetes, perhaps a blood test like this might be another opportunity to risk stratify or early detect pancreatic cancers.
That's great. Excellent. Thanks for the perspective. I really appreciate it. If we transition a little bit then from thinking about how the test could be used and think about it from the perspective of what does this mean for Immunovia going forward now that we have these positive results from our first clinical validation study, essentially it means that we will continue on the plans that we've laid out for investors previously. So we are on track to launch our next-generation test in the second half of next year, as we've previously announced. One of the things that we are very focused on that we've talked about previously is securing a strategic partner that can help us commercialize this test. We've certainly had a positive initial reaction from those strategic partners.
We have a number of meetings that are scheduled at the end of this month, as well as in January and some into February, and we'll continue to pursue those conversations. The timing of a potential deal or a potential partnership is one that is really difficult to predict. We want to make sure that when we do sign that deal, that we're getting adequate value for what we're bringing to that partnership, but we are very excited by the initial reaction. One of the things that we will continue to do is additional clinical studies that will help us to build the evidence that we need in order to secure reimbursement for the test from both government payers as well as private commercial insurance companies in the U.S.
Both of those groups have specific standards in terms of the types of studies and the number of studies that they look for, and we've got a plan to meet those. One of the things that I'm very pleased about is the fact that we can address those needs relatively quickly and at a reasonable cost because of, for example, the relationships that we have with different experts in the field, as well as our existing biobank. Those advantages will allow us to move through that clinical plan relatively quickly and at a reasonable cost. And finally, we will continue to make sure that we have the capital needed to support the business. When we finished the third quarter, we shared as part of that report that we believe we have 12 months of cash going forward.
We have the upcoming warrant series, the TO2 warrants and the TO3 warrants, and we're optimistic about the proceeds that we will get from those warrants to support the business throughout 2025 and beyond. And with that, we'd like to open it up to the audience to ask questions that you might have. You can use the chat function within the webcast to submit those questions, and we'll go ahead and ask them once we see them. The first question: Is this test performance good enough to go to market? And we absolutely believe that it is. I think you heard that from Dr. Lucas in terms of her excitement about the results. Both when we look at the overall results, where we saw that sensitivity of 78% and the specificity of 90%, we know that that compares well with the imaging that's done today.
The thing that we also know is that we can expect better performance from the test in market because of the fact that we will be using newer samples when we run clinical samples. So we feel very good about the market potential. Next question: Any bigger investors in sight? I think this is a great question. Today, if you look at the investor base for Immunovia, one of the things that you don't see are a lot of large specialist institutional investors. We are certainly working on conversations to bring investors like that on board, and we're hopeful that we can do that over the coming year. What can you say about the design and goals of upcoming clinical validation studies, perhaps in relation to CLARITY?
So, Norma, I'll hand that one over to you to talk about what we learned in this study will impact our next clinical validation study.
Sure. Thanks, Jeff. Certainly, we have publicly said that we will be doing another clinical validation test. And I think the reason I think that question has come up in the past is why we would want to do another validation test. As scientists, we want to ensure that we see this data be able to be replicated in a separate clinical population. So that's certainly something we plan to do. Also, the findings from this current CLARITI study wherein the sample age was somewhat of a factor in terms of performance is important, and that will be taken into account for the next clinical validation test. In terms of additional studies, we would like to conduct, as Aimee mentioned, there are some other high-risk populations that are of note within the clinical space, such as those harboring pancreatic cysts, those with new-onset diabetes.
We feel that those populations of real-world analysis of the populations in independent studies is really important. Those are studies we actually have planned, looking forward to in the 2025 year for those additional kind of evidence for the performance of the test.
Excellent. Another one for you, Norma. You mentioned a 78% detection rate of stage one and two pancreatic cancers. Was that in healthy individuals, and did you actually discover the cancer in anyone that did not know they had it?
The 78% detection rate, as I had mentioned in the presentation, our control patient population were those only at high risk for pancreatic cancer. These were genetic, familial, or some kind of clinical suspicion of pancreatic cancer that was excluded through imaging analysis. We did not have any healthy controls within the study itself. As I mentioned, this is a much more complicated and patient population to test in. I think we were really happy to see this high sensitivity in this very complicated control population, so not in healthy controls. In terms of did we actually discover cancer to anyone we didn't know that they had, we are still taking a deep dive into the details of the study. That's definitely some information we will be looking for.
How does a 75% funding level from TO2 affect the plans going forward? This is based on the current level the stock is trading at. So that is in line with the assumptions that we have made in our forecasts. And so that would certainly fully support the plans that we have going forward. Is the CA 19-9 a competitor to the Immunovia test? I think that's an interesting question. I think that, as Norma mentioned, CA 19-9's sort of approved use is for monitoring recurrence in people who have had pancreatic cancer, essentially trying to understand, is that cancer coming back after it's already been diagnosed and treated? But the reality is that we do know that there are clinicians who use CA 19-9 as part of their early detection protocol.
So for example, when we were at the APA meeting last week, we spoke with a clinician who runs a surveillance program. He does endoscopic ultrasound each year for his patients. And then on an interval every six months in between that, he does CA 19-9 as well. So generally speaking, we don't see it as an early detection tool. Some clinicians do use it that way, but it's an important benchmark for us in terms of being able to show superior accuracy to CA 19-9.
I did want to add, Jeff, that in the NCCN guidelines and other guidelines within the U.S., CA 19-9 is listed for, as you mentioned, recurrence. But of note is that they actually exclude CA 19-9 for detection due to, as I mentioned in my presentation, very low sensitivity and kind of inconsistency of those results. So they're actually excluded in the guidelines and not approved for that use early detection.
Question: Is U.S. your main go-to market outside of E.U., or are there plans for Asia, Oceania, et cetera, too? So certainly, we know that this is an issue that impacts people worldwide. You mentioned Asia, and we know that the incidence of pancreatic cancer in Asia can be quite high in certain countries. So we do see potential for this test beyond our initial market of the U.S. and beyond Europe. What we plan to do is to take sort of a sequential approach to this. We will focus initially on the U.S. It is the largest market. It is the market where we have the best opportunity to get an attractive price for the test. But certainly, over time, we will look to take the test into other markets as well. And that's really another place where a commercialization partner can be really important.
We talked earlier about the idea of having a large diagnostics company as a partner to help us bring the test to market in the U.S. That would also obviously be a great way to move into, for example, the Japanese market or the Korean market or the Chinese market, where those are somewhat unique markets. They have local companies that know those markets very well. And so a business partnership could be an excellent way to do that. A couple of questions here about competitors and how do we think about competitors. So one of the questions is, do you have any big competitors? And I would say that they are not a direct competitor, but the large competitor in our space is Grail, which has a test called the Galleri test. You may have heard of it. It's a multicancer detection test.
Pancreatic cancer is one of the cancers that it detects. We do believe that there is an opportunity for a pancreatic cancer-specific test for those individuals that are at high risk. Dr. Lucas talked about the fact that the risk of pancreatic cancer is not high enough in the general population to justify testing everyone for pancreatic cancer at this point. So we think that there is a need for a pancreatic cancer-specific test, and we need to have the kind of sensitivity and specificity that we saw in the CLARITI study. That Galleri test, when you look at stage one and two pancreatic cancer, which is really our goal, the sensitivity was only about 60%. So that's the primary large competitor. There are other smaller companies that are also developing pancreatic cancer-specific early detection tests.
And so our goal is to continue to show that we've got the kind of sensitivity and specificity that we saw here and even better when we have testing done in newer samples. Norma, do you plan to present the CLARITY results at a scientific conference or publish them in a journal?
Absolutely. When we started the studies, especially the CLARITY study, we were making a very deliberate decision to share externally our data, and so this is a very deliberate effort we're making as we presented at various meetings. We continued that with the model development study. We actually shared recently that the discovery paper discovery study was recently accepted for publication in the Journal of Proteome Research, so yes, the plan is. We've actually resubmitted this data to an upcoming medical conference as well as put into a manuscript for publication in a peer-reviewed journal, so that is absolutely our plan, and we look forward to sharing that with you.
Question about pricing here. Within what range will the price of the Immunovia test be? We expect that the test will have a price that's relatively similar to our initial test, the IMMray PanCan-d test. In the U.S., the rate for that test was just under $900, and we would expect that this test would be priced in a similar way, which we consider to be a very attractive price given that this is not a test that would only be done one time. It's a test that would be done on an annual basis as part of the surveillance that Dr. Lucas described. Are there any plans to confirm the prevalence in high-risk individuals in upcoming studies? Norma or Dr. Lucas, any thoughts on looking at prevalence in high-risk individuals?
Just before Dr. Lucas answers, just one piece. I think there's an understanding that that prevalence rate is very difficult to nail down. It's quite small. I think we have engaged with external statistician groups to understand how we can do some kind of modeling to establish that within our dataset. But in terms of direct work around confirming that prevalence in high-risk individuals, I think that's actually a question for the clinical space itself. So I'll turn that over to Dr. Lucas.
I think it's a great question. So I'm interpreting this as the prevalence of pancreatic cancer in individuals who we've defined at high risk. And so.
Yeah, I think so.
That prevalence varies widely. We know from studies in familial pancreatic cancers that prevalence changes with the number of affected, typically first-degree relatives. So those are people kind of one step away from you in the family tree. It could be a parent, a sibling, or sometimes even a child. So somebody who has two first-degree relatives might be on average at a slightly lower risk than someone who has three first-degree relatives or five family members affected, but also might be at a higher risk than somebody who has one parent affected. And so those are studies that we are all working on within the PRECEDE Consortium. I know Jeff mentioned that group early on, and there are a number of efforts to really get at this question of what is the risk of pancreatic cancer for high-risk individuals. I mentioned a threshold of around 5% lifetime risk.
And these are estimates based on the larger scientific data that we have. So that's kind of the cutoff, at least in the United States, where we think that surveillance or screening would be indicated in a high-risk individual. But the truth is that incidence changes with different genes, with a gene plus a family history. And certainly, age is always the biggest risk factor. So you could imagine somebody with a BRCA2 variant and no family history at the age of 30 has a very low risk of pancreatic cancer. But maybe that changes after some lifetime exposure, tobacco. Maybe they've gained weight. Maybe they're now 70 years old, and maybe now they have new-onset diabetes. So we can think about different ways where that prevalence and incidence sort of changes over time, even within one specific individual.
And then we know that there are certain genes that have a very high lifetime risk of pancreatic cancer, 30%, 40%. Thankfully, these genes are very, very low where very intensive surveillance for pancreatic cancer is really warranted. So the short answer to the question is it depends, and it varies based on the specific patient and their genetic and familial and environmental risk.
I apologize. We're running short on time, but we do have a number of additional questions. I'll just answer one last one here as we wrap up. Is selling the company or merging an option in the search for the right partner for the U.S. launch? And what I would say is that's definitely an option. We are open to partnership that could take a variety of forms. Our primary goal is to focus on getting this test to be characterized as well as we can through as many studies as we can and to get as many physicians and high-risk individuals aware of the test and educated about the test so that they can make a decision about using it. Our goal is to really, really make an impact in the survival rate of pancreatic cancer.
If the best way to do that is to become part of another company, either through an acquisition or a merger, we will absolutely do that as long as it makes sense for our shareholders and makes sense in terms of the economics of that opportunity. I appreciate all of the questions and also want to say a special thanks to Dr. Lucas for joining us today. She is incredibly busy. She essentially has about three jobs within one job. She is a researcher. She is a clinician, and she is also an administrator of the hospital. We're very grateful that she joined us today. Thank you for the information, and thanks to all of you for joining us. Take care.