Thank you, Patrik. Welcome to the call. Before we begin, I'd like to give a quick reminder to our listeners. Today's webinar and call management may make forward-looking statements that involve known and unknown risks, uncertainties, and other important factors beyond the company's control that could cause the company's actual results, performance, or achievements to be materially different from the expected results, performance, and achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements. Reported results should not be considered as an indication of future performance.
Please note that these forward-looking statements made during this webinar speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. Now, I will take you to the agenda. In today's call, we will go over third quarter 2020 highlights. We will talk about the remaining steps to launch, our road to market, the discovery studies, and we will summarize before we go to Q&A. Now, with these formalities over, I'd like to turn the call over to our CEO, Patrik Dahlen. Patrik?
Thank you very much, Julie. It's truly an honor and a pleasure to be here today. It's obviously my first quarterly report, reporting for the quarter three of 2020 for Immunovia. A big thank you to all our employees, who has made this quarter an exceptional quarter for Immunovia. I'd like to start off by moving into the helicopter for a while and take a look at sort of what is important to Immunovia right now. Obviously, it's really all about all hands on deck for securing a sales start in quarter one of 2021, so just a few months into the future. Why is this important? Well, first of all, we want to be first to market with a solution for early detection of pancreatic cancer. Pancreatic cancer is one of the hardest to detect and diagnose cancers.
This means that whilst it's not the most frequent cancer, it is one of the most deadliest cancers in the world. In the U.S., it's the third deadliest cancer to date. The main reason for this being such a deadly cancer is the late detection, the late diagnosis of pancreatic cancer, so it becomes difficult to treat. This is why we, Immunovia, have a very important mission to be providing a future opportunity for early detection of pancreatic cancer. This is also why we, in our assessment of the market, can see that there is a great market opportunity for us in the excess of $4 billion, according to our own estimations of market size. As I said, we are planning to start sales of our IMMray PanCan-d assay in the first quarter of 2021. We are well-funded.
We are fully funded as a company for the commercial rollout. We have cash at hand, SEK 510 million. We're well-funded for the commercial rollout and beyond. We are a company in great shape. As you all know, our commercial activities in the long run are aiming at achieving a 30% market share for IMMray in terms of early detection of pancreatic cancer. We are very ambitious in our goals for the future. In terms of quarter three, we have been very busy. It's been an exceptionally busy quarter for Immunovia. If I start by looking at organizational changes, obviously in August, we announced that I would be stepping in as the new CEO following Mats Grahn, who has been the CEO of Immunovia for almost eight years.
On that note, Mats then was elected to move into the board of directors, which was verified by the extraordinary general assembly in September. In terms of marketing activities, we have presented at the European Pancreatic Club and the International Association of Pancreatology, which we did in July. We have also launched the Immunovia Walk around the World, and I'll come back to that at the very end of our discussion today. The main highlights for quarter three for Immunovia is clearly the results from the CTMS that were announced in the beginning of September in a webinar, and I'll come back in depth and discuss about those results. As well as the more recently announced results from our verification study, which again, I will present in more depth in the next slides to follow.
If you start with the CTMS study, it was a large multicenter case control study, where we had patients enrolled both from the U.S. and Europe. In total, 1,113 serum samples with 315 PDACs in Stage 1 through 4, 310 healthy controls.
We are currently experiencing some technical difficulties. Please stand by while the line is swapped. Could I please ask the host of the call to swap to their mobile device? Thank you.
Okay. I think we're back.
We're still experiencing some issues. Sorry for that. Two seconds. In the beginning of September, we hosted a webinar focusing on the commercial test model study, or the CTMS study as we call it. Which was a multicenter case control study, with eight U.S. and European sites participating. We had a large number of serum samples, 1,113 serum samples in all, 315 PDACs in Stages 1-4 , 310 healthy controls, and 488 symptomatic controls. We performed the study using our eight plex biomarker signature, with the addition of CA19-9 included as a part of the biomarkers that we use. We were able to arrive at really great results, with an area under the curve of 0.94. For PDACs versus all controls and for PDACs versus symptomatic controls, we had an area under the curve of 0.93.
Very great performance, and a good outcome of the study, which then, of course, enabled us to move forward towards the next important study, which we just announced recently, i.e., the verification study. In the verification study, it was again the multicenter case control study, covering 519 patients with 81 PDACs in Stage 1 and 2, 114 PDACs in Stage 3 and 4, 212 healthy persons, and 112 symptomatic controls. The PDACs versus healthy controls came out at an area under the curve of 0.94. The PDACs versus all controls came out at area under the curve of 0.91. We then analyzed the data further, we looked at the specificity of the test, and for differentiating early Stage 1 and 2 PDAC patients from healthy controls, we derived at a specificity of 99% and a sensitivity of 78%, with a negative predictive value of 0.993.
Clearly giving us a very good indication that we have a very specific test, and with a high sensitivity enabling early detection of PDACs even as early as Stage 1 and 2. The early Stage 1 and 2 PDACs were also differentiated from all controls at a good accuracy of 91%. There, the specificity was 93%, sensitivity of 78%, and the negative predictive value of 0.993, again. It's very important to say that this study was conducted with known samples using a verified software, locked production processes, and locked QC methods, everything run in a locked version that was concluded from the CTMS study. We're very pleased with the outcome of the verification study, and this enables us to move forward to the next stage in our development towards the road of commercialization.
Obviously the next step is a validation study where we repeat everything again, but this time with completely blinded samples. That was quarter three, and now I want to talk a little bit about the remaining steps to launch as the next discussion. We've obviously taken multiple steps towards commercialization. It is a long road, obviously, and we are nearing the end of it. We just completed the verification study with the locked signature and algorithms and with known samples. We just reported that. We are now in the validation study process where we are collecting the last samples. We will be running the validation study with locked signature and algorithms like we did for the verification study, of course, and this time with blinded samples.
This now enables us, according to the plans that we have, enables us to launch the test in the United States. in quarter one of 2021, with subsequent testing starting and following in quarter two of 2021. We're very pleased with where we're at. We think we have made great progress during the year and during the quarter, and we are very excited about the outlook for the quarter one. With regards to the market, again, I just want to go back and reiterate that this early detection of pancreatic cancer is an extremely important healthcare measure. This is a very severe disorder. It's important that we detect the cancer early so that the doctors can operate on it, and that we can treat properly the cancer. As you all know, the survival rate is as low as 10%.
Some countries even reported lower than that over a period of five years post-treatment or post-detection. Therefore, it's important that we are able to provide an early detection so that patients can be better treated going forward. We have three patient groups that we address. One is the hereditary or familial group of patients. There's about 200,000 patients in EU and U.S. The idea would be to monitor those patients twice a year. That in itself is a very interesting market group for us or a target group for us. The other risk group that we have is the symptomatics or those with early concerning symptoms. There's about 1 million new patients every year with concerning symptoms. These patients, we are assuming our model would need one test per patient.
The third risk group that we see is the new onset diabetics with an age of over 50 years. Of that category, there is circa 3 million or more new patients every year, and they would need a test per year in a couple of years, sometimes even more frequently. This is also a growing group of patients that we see that are in the risk group or in the addressable group, so to speak. This is a very large market, and it's a very big healthcare concern that we are addressing going forward. The road to market, how do we proceed from here? Obviously, the first wave of commercialization is in the United States. We have a lab set up.
We're going to conduct the validation study and run that so that we can file for state approval, get the clear, and start the testing in the United States in our lab in Marlborough, in Massachusetts. This is also the most important market for us, clearly, and not only short term, but also long term. The U.S. remains to us a very important marketplace. The second wave of commercialization is in Europe. Obviously, our own home market being Sweden and the Nordic countries, followed by the EU Five, which is very important for us. We have a number of countries where we already have very close collaborations with key opinion leaders and also, as you would imagine, from sites that provide us with prospective samples. These are obviously also areas where we will be focused in terms of our early commercialization here in Europe.
Obviously, this will follow once we are commercially successful in the United States. The timelines we have discussed, I think, many times before, but I'll just reiterate those. Obviously, when we look at the time to market, I'm sure there are investors and analysts out there thinking we've been going at this for quite a while. It is a unique and very difficult task, of course, to provide an early detection for pancreatic cancer. It takes a number of well-designed studies to get there. In the past to date, obviously, we focused a lot on the retrospective studies, doing now then the optimization of the test, and we are now proceeding to the final portion of that, i.e., the first verification which we have performed, and now the final stage of that is obviously the validation.
In parallel with this, we have already started back in time prospective clinical studies. Collecting samples to be ready to analyze with the finalized test and the validated test, and to provide clinical prospective evidence of the effectiveness of the test also going forward. This will be very important in the long run for us to provide data to the payers and the decision makers and the key opinion leaders with regards to the evidence of detection and the discussion around reimbursement rates. Obviously, in the short run, especially in the United States, there is a possibility to launch the test, and this is what we will be doing for self-pay sales. There is a large cohort of individuals who have a familial history, a hereditary trait, and there is an interest there.
Of course, people in general who are concerned about their health will be able to enroll in a self-pay approach. Then, of course, we will continue going forward, confirmatory market expansion studies in different geographies, et cetera. We have and continue to be very focused on the United States and Europe. Personally, I think also the Asian markets with Japan and China in particular, where we see very high incidence of pancreatic cancer, obviously in the future will become even more important for us as we move forward. In terms of discovery studies that we have ongoing, just a couple of words on those before we move on. The discovery studies that we have are in early stages. We're obviously active in two areas. One is in lung cancer, where we aim for early diagnosis.
We're doing sample collection at the moment to get a proper patient cohort to analyze. We will be announcing data as we move forward. Again, it is early stage, and therefore there is no firm timeline with regards to announcements of new data in that field. For rheumatoid arthritis, the situation is almost the same, i.e., we're early stage. It is discovery stage. We do have a biobank there. Unfortunately, it's of historical nature, and given our history with regards to historical samples, we cannot only rely on that. We have started prospective collection also for early discovery stage work there. Obviously, with rheumatoid arthritis, it's not for early diagnosis as it is for lung cancer. There, it's more for accurate detection and being able to distinguish the different groups of rheumatoid arthritis that exist and that are hard to diagnose, yet important to diagnose.
Moving forward, in summary, I think Immunovia is in a very exciting part of its journey. We're just months away from starting sales in the U.S. We're moving very quickly forward towards that. We have all hands on deck, completely focused on that task and that task alone. We are committed to succeeding with that. With that, I'd like to open up for any questions that you may have.
I can see that we currently have a question in the phone queue. Our first question comes from the line of Viktor Sundberg from ABG Sundal Collier. Viktor, you are now unmuted. Please go ahead.
Yeah. Hi, thank you for taking my questions. My first question relate to the recently announced verification study. If you back out the specificity and sensitivity of IMMray in PDAC Stage 1 and 2 patients compared to only symptomatic controls, at least I get a mid-80s number for specificity and a high 70s number for sensitivity. Do you think the test needs to perform better than that in order to screen or test the new onset diabetes population, for example, given that it's almost 1.5 million Americans that get this diagnosis every year? Do you feel confident with these numbers, so to speak?
We do feel comfortable with the numbers. Obviously, given the better performance against healthy controls and unsymptomatic individuals, we would have hoped for a higher number. It's really all about sort of the prevalence of the disease and PDAC versus how many samples we call negative versus positive. At this stage, we feel comfortable. Obviously, we still need to continue to work with the key opinion leaders and work with the clinicians to also get their view and their feedback in terms of how they see the sensitivity and specificity in this particular group. As we sometimes have also discussed in terms of the diabetics, there are subgroups also of the diabetics. It also is a little bit of question of being able to possibly enrich the group of diabetics.
I have been a full week and a few days here in Immunovia as the CEO, so it's a little bit early for me to maybe give a complete clinical response to your question. Basically, this is kind of our or my early thinking about where we're at.
Okay. Thank you. Could you also perhaps add some flavor on the rationale for combining IMMray with CA19-9, as we've seen in the later studies here?
We think the IMMray and CA19-9 as a combined panel really. It is important to include both components. They kind of work together, and they enhance each other. That is, I think very clear to say that CA19-9 combined with IMMray is very important and cannot be kind of separately discussed, if I put it that way.
Okay. Thank you. Will you also keep the market updated around when you have all the samples needed around the validation study? Also just to clarify, will the size of the validation study be the same as the verification study, or will it be bigger to compensate for any discarded tests?
We have inclusion and exclusion criteria, obviously, for our samples coming in. We do the exclusion just based on that. We don't discard samples during the study per se.
Of course.
We obviously, when we have the data from the validation study, we will be announcing that and giving that data. We have discussed previously with the market that given the COVID-19 pandemic and the sort of uprising again of the COVID-19, we have seen a decline in collection of prospective samples. However, that said, the timelines that we now have set with regards to being able to complete the validation study are still valid, and they take into account the slightly slower or the much slower, I should say, collection rate that we see at the moment. This has been taken into account, and we don't anticipate any delays in getting the samples ready for the validation study.
Okay. Just a final question from my side before I jump back into the queue. This prospective interim readout is planned for the first half of next year. What in terms of data should we expect from that interim readout?
I don't want to speculate on that now. Again, it is my second week here, not even completed yet. So that is a question that I will need to get back to you, Viktor, later on and give you feedback on that.
Okay. Thank you very much.
Thank you.
Welcome to Immunovia.
We have no further questions in the phone queue, but please be reminded, if you would like to ask a question, please press star one on your telephone keypad now.
While we wait for that, we do have a couple of questions that have come in on the web portal, so I will ask those. The first question is, what does with subsequent commercial diagnostics testing during Q2 exactly mean?
What it means is that in Q1, we will do all the launch activities and the sales start, which means that our sales force will be addressing prospective customers. Given that we don't fully control how quickly the state gives us a clear certificate.