Ladies and gentlemen, welcome to the Immunovia Q2 Interim Report 2022 conference call. I'm Moira, the conference call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Karin Almqvist Liwendahl, CFO. Please go ahead.
Thank you so much, and welcome to all of you joining us here today for the presentation of Immunovia's second quarter results. Present here in Lund is Philipp Mathieu, our CEO, and myself, Karin Almqvist Liwendahl, and I'm the CFO. Joining from the U.S. is Jeff Borcherding, our CEO of our U.S. Operations. Before we start the presentation, some practical aspects. There will be a Q&A session afterwards, and our operator will guide you on how to ask the questions. For the sake of convenience, we kindly ask you to limit yourselves to two questions at a time. We aim to close the call at 2:00 P.M. the latest, whereafter you will find it uploaded on our website. With that, I'd like to hand over to our CEO for the presentation. Philipp, please.
Thank you very much, Karin. Also from me, welcome to today's Q2 conference call to those who join us from Sweden, but also the ones who join us from the U.S. I would like to thank you for your interest in Immunovia and our journey to become the undisputed leader in blood-based pancreatic cancer testing. At Immunovia, we are focused on one single mission, advancing early detection of pancreatic cancer and increasing the survival rates for one of the deadliest cancers. This mission is hugely motivating for all of us, and I'm excited to share with you today the progress we've made during Q2 of this year. As an agenda for today's Q2 call, I intend to cover the following topics.
Firstly, I would like to reiterate the sharpened strategic focus of the company, which enables us to laser focus on penetrating our target market with its huge unmet medical need. Secondly, I'm going to revisit the operational highlights during Q2 that show the progress we've made in scaling our U.S. business for continued successful launch, as well as in making our test broadly available in the U.S. Thirdly, Karin will shed some light on the financials of this quarter, and Jeff will lastly give an update on our commercial progress, covering how our test is used already today by surveillance centers, doctors, and patients, the progress with our physician experience pioneer program and what we've already learned to drive further adoption of our test, our progress in pursuing our reimbursement plan, and the different commercialization phases in which we plan to scale our U.S. commercial business.
At Immunovia, we are in the middle of successfully transitioning from a previously R&D-focused company to an Immunovia, which is successfully executing commercially and penetrates a highly attractive market. This is a market with this huge unmet medical need, which we sized at an estimated population of 1.7 million-1.8 million patients in the U.S. alone. We are today the undisputed front runner in the non-invasive detection of pancreatic cancer, a position which we are further strengthening every quarter. Having built a marketing team in the U.S. early on enabled us to have a second to none reach amongst patient advocacy groups, key opinion leaders, and physicians. This is a key advantage now as we scale our U.S. commercial organization and increase awareness as well as share voice in the U.S. market. During this current phase, we as management team are focused on two things.
First, building out our U.S. commercial team to enable the successful uptake of our tests. Secondly, executing on our U.S. reimbursement plan to allow the broadest access possible for patients in the U.S. Obviously, successful execution requires laser focus in our core competencies in pancreatic cancer. This is a natural step we took during the second quarter. Let's focus on the large unmet medical need for the early detection of pancreatic cancer. Already today, pancreatic cancer is number three among the top 10 cancers by number of death in the U.S. This year, more than 60,000 individuals are expected to be diagnosed with pancreatic cancer. This number is increasing year-on-year, which is unique among all common cancers. Within the next five-10 years, pancreatic cancer is expected to overtake colorectal cancer. What makes pancreatic cancer stick out are the very low chances of survival.
At the five-year interval, the survival rates for pancreatic cancer are by a large margin the lowest among all more common cancers. Main reasons for the very low survival rates are late diagnosis, fast tumor progression, and limited treatment options at later stages. Late diagnosis is most common due to not enough people who are at risk being part of surveillance programs, the cancer being asymptomatic until the later stages, often only being picked up by coincidence, and significant shortcomings of current surveillance and imaging methods, especially in early detection. Now, compared to the huge unmet medical need, innovation in pancreatic cancer, and in particular, new testing methods, have been almost nonexistent. Today, still CT and MRI are the most common methods of diagnosis, but most often, either of them diagnose pancreatic cancer are only in inoperable stages 3 and 4.
Jeff will later spend some time on the limitations of the current surveillance methods, which our test overcomes. With our test, we are the first one to launch a dedicated test for pancreatic cancer that provides an option for early diagnosis. Why is early diagnosis so important in pancreatic cancer, and why is our test a game changer? As of today, as per the National Cancer Institute, the overall survival rate for pancreatic cancer is 11.5%, as you saw on the previous slide. Other estimates from Cancer Research UK for PanCan are even lower, between 5% and 10%. What makes the huge difference is the stage at which the cancer is being diagnosed. Treatment options, be it therapeutics or chemotherapy, have not really evolved over the past decades and lack the progress made in other cancers.
Surgery still remains the go-to and most promising option if possible. Now, surgery is only an option if the cancer is not metastatic yet. Unfortunately, less than 20% of patients are today diagnosed early enough for that to be the case. More than 80% do not have that option, and five-year survival rates drop to 3%, which is dramatic. Reasons for that are lack of surveillance and screening, mainly for at-risk individuals, but predominantly the shortcomings of current standard diagnostic methods to deliver early enough diagnosis. Our mission now is to allow more patients to benefit from surgery as a treatment options and have five-year survival rates of not 3%, but more than 40%. That is where our test makes the difference. Moving that less than 20% of people to a significantly higher number, which would drastically improve survival rates.
That's where Immunovia with our unique test comes in. Today, we are targeting the risk group of individuals with the genetic and family risk factors as the first risk group we are commercializing. This is the one we are focusing our commercialization efforts on since late last year. I will let Jeff later explain some more commercial details and outline the go-to-market approach today and going forward. What is important to understand to size the opportunity for Immunovia is that with that risk group alone, we are just scratching the surface. The two risk groups we are in research phase and plan to launch in the future are substantially larger risk groups. The symptomatic risk group, around 600,000 patients. This comprises patients with concerning gastric symptoms.
The new onset diabetes risk group, another 850,000 addressable patients per year, by far the largest risk group. Across those risk groups, we estimate a patient population of 1.7 million-1.8 million patients annually in the U.S. alone. This is a vast market opportunity for Immunovia, which we will penetrate. Now, what is the progress we made during Q2? First and foremost, we strengthened our US management team. The start of Jeff as a commercially highly experienced leader of our US business and also the recruitment of Natalie Carfora as our Head of Market Access, were two critical steps in strengthening our US leadership team.
Already now, I'm very pleased with the significant difference Jeff and Natalie make in driving our U.S. commercial business forward, be it in our conversations with payers and insurers, pushing our reimbursement plan, in increasing awareness and adoption of our test among physicians and patient advocacy groups, and in further refining and executing our commercialization plan for the U.S. The results of our PanFAM-1 prospective trial further validated the specificity of our test, which we've seen in the peer-reviewed validation study results. While sensitivity could not be assessed due to the low number of pancreatic cancer cases, we are currently working with key opinion leaders to assess the key learnings, as well as publish those conclusions. Obtaining the PLA code for IMMray PanCan-d was another important step towards reimbursement. It provides a unique code for our test that prescribers can use.
We also made significant progress in obtaining licenses in the remaining U.S. states. After Q2, we added California and have now only New York outstanding, making IMMray PanCan-d available in all but one state, where our sales reps are now able to market our test. We also further enrolled our pioneer physician experience program, which will drive familiarity and adoption of our test amongst physicians and surveillance centers. Both doctors participating in the pioneer program and key opinion leaders will be key advocates with payers regarding our test and reimbursement. With the progress made during Q2, we have further built out our front-runner position in the early detection of pancreatic cancer.
I am convinced that we now have the right team, strategy, and momentum to deliver on our strategic priorities and generate significant sales growth, especially once reimbursement is in place. With that, I would like to hand over to Karin, who will talk about the Q2 financials, as well as later Jeff, who will detail our commercialization strategy and progress we've made there.
Thank you. Being in a commercial build-up phase, as you can see, our revenues are still at very modest levels. However, if we look upon it from a cost perspective, that build-up is not yet reflected in our numbers. I'd like to give you a few remarks now when comparing our financial performance quarter-over-quarter and also year-over-year. As you may have seen, we have lower external expenses, which is relating to how we have accounted for our clinical studies. This is a timing effect and does not represent a trend change. On a net profit level, when we compare between the years, there are some items to take into consideration that otherwise could distort the picture.
These are, as mentioned already in Q1, capitalization of our R&D expenses in 2021, which was completed Q2 2021, and thereafter we have started to depreciate. Depreciation is another aspect to take into consideration. Thirdly, and finally, we have quite substantial currency exchange effects impacting our numbers. Taking all this into account, the underlying trend is stable and is quite comparable to what we have seen historically. Our cash position remains solid, and it will enable us to cater for our plans well into 2023. By that, I hand over to Jeff. Over to you, please.
Mr. Borcherding, we cannot hear you. Maybe your line is on mute.
Good morning. As Philipp Mathieu mentioned, I wanted to share with you some of the things that we are seeing in the marketplace around pancreatic cancer diagnosis and the limitations that exist currently. You see here the fact that we've got too few patients that are under surveillance. Only about one in five patients who qualify for high-risk surveillance are actually enrolled in a program. There are a number of reasons for that, including lack of awareness, including distance from the centers which are concentrated in urban areas, and the fact that many patients are not comfortable going through the annual imaging that's required, and that imaging is burdensome on those patients. In addition to that, the imaging that's done can often be inconclusive.
We've got meta-analysis data that shows that MRCP or MRI and endoscopic ultrasound are similar in sensitivity to the IMMray PanCan-d test, but have significantly lower specificity, meaning that there's a greater risk of a false positive that creates further anxiety for the patient while the clinician is doing the additional work to understand whether that positive result on imaging is actually pancreatic cancer or if it was a false positive. Imaging has a number of limitations in terms of identifying pancreatic cancer early. As Philipp Mathieu talked about earlier, that is a critical part of increasing survival. It's not sufficient to identify cancer at stage three or stage four. We have to be identifying that PDAC at stage one or stage two when there are more treatment options available for that patient. Imaging often fails to detect small tumors.
What we see as well is that for patients in these annual surveillance programs, data shows that some of those patients progress very quickly from having no evidence on imaging of pancreatic cancer to having stage three or stage four cancer just a year later. That's where IMMray PanCan-d can obviously make a tremendous difference. What we're doing now as we bring IMMray PanCan-d to the market is really working with our clinicians to make sure that they understand what does the IMMray result tell them, and what steps should they take based on that. As we are moving forward with our PIONEER physician experience program, a key element of that program is helping clinicians understand how to respond to different results that they get with our tests.
Some of the challenging results come when a patient receives a borderline result, meaning that we are not able to clearly and definitively state that that patient is negative for the IMMray PanCan-d high-risk signature, but they're also not quite at the point where their protein levels indicate that pancreatic cancer is present. We're working with clinicians to develop protocols and integrate that learning into their overall treatment plan for that patient. Similarly, there are times where the high-risk signature present result will occur in a patient where the physician is not seeing pancreatic cancer on imaging. In some cases, that might be a false positive, but it's also very likely that those patients could be developing pancreatic cancer and that cancer is just not yet visible on the physical imaging that's done.
Helping clinicians understand how to proceed in that situation is an important part of what we're doing as part of our launch efforts. We've talked previously about our physician experience program. We're very pleased with the progress of the program to date. It is almost fully enrolled. We have the program commenced at 19 high-risk surveillance centers across the United States. Actually, I've spent the last three weeks traveling the United States, meeting with pioneer participants to understand how the program is going, what they are learning in their use of IMMray PanCan-d, and the response has been very positive. There is a high level of enthusiasm among our clinicians, and I think that enthusiasm is really driven by the excitement that high-risk individuals have for this test.
There has been a long-held desire among those patients to have a blood-based test that would give them insight into whether pancreatic cancer is developing, and IMMray meets that need, and they're very, very excited to see that come to market. I mentioned earlier that these clinicians talked about the fact that they're learning when to use the test, with whom to use the test, and then how to utilize the test results that they receive. One of the important things that we're trying to do with this program is develop advocates. Those advocates are going to be important in a number of ways, but two are really critical. The first is those early adopters of the IMMray PanCan-d test through the Pioneers program will be important advocates for us to convince other clinicians to incorporate IMMray PanCan-d into their pancreatic cancer surveillance programs.
In addition, these early adopters of IMMray will be critical advocates for us as we go and seek reimbursement from commercial payers in the United States. There are a number of factors that those payers will consider as they look at our application for coverage. They'll look at things like our clinical data. One of the things that they will also look at is what is the level of adoption and advocacy within the physician community. Developing those advocates who are willing to join us in meetings with payers, advocate for the test being covered, speak to its importance in the use and detection of pancreatic cancer is going to be really crucial. The other aspect of the program is that we are collecting imaging results from these clinicians and their patients.
We talked earlier about the PanFam study, which was a long prospective study where we collected samples across several years from patients who are in pancreatic cancer surveillance programs. Unfortunately, we didn't see the number of PDACs in that study that would have enabled us to assess the sensitivity of the test. We are seeing, as we use the test in clinical practice, more positive results. As we start to see how those patient scenarios play out, we'll get additional data that will support not only the specificity of our test, but also the sensitivity of our test. If we could go to the next slide, you know, the Pioneers program is really the first step in this process. It is a physician experience program, and it is part of our launch efforts. We are thinking about our commercialization of IMMray PanCan-d in a phased approach.
We're currently in the launch phase that you see here, very focused on the risk group, which is those patients who have genetic and familial risk factors for pancreatic cancer. Our call point or the physicians that we're talking to is pretty narrow at this point. We're focused on high-risk surveillance centers. There are about 200 of those across the United States. In addition, we're focused on interventional gastroenterologists and pancreas specialists within GI practices. The way the market is set up in the United States, there are about 8-10 GIs in a typical gastroenterology practice. Typically, one of those physicians focuses on diseases of the pancreas. That is the key target for us, in addition to the GI within that practice who is really the specialist in doing interventional work through the endoscope. We've got a narrow target audience in our launch phase.
In addition, we are narrowing our geographic focus to six to seven territories, which will enable us to cover about 18 states. As time goes on, we will move into our growth phase. The key change there will be the expansion of our sales team and increasing our geographic reach. In addition, we may have an opportunity to expand into the market for IPMNs. This is a certain kind of cyst that is at greater risk of developing into pancreatic cancer over time. What we know is that in the studies that we've done previously, about 30% of the patients in those studies have IPMNs.
We have some promising data in that risk group that we will be looking to further expand on in coming months. Finally, the thing that will trigger our expansion over the longer term is being able to increase the number of risk groups where we use the IMMray PanCan-d test and expanding to those additional intended uses like chronic pancreatitis and most significantly, new onset diabetes. As we do that, we will need to determine our commercial plans in order to reach a much larger target audience of clinicians, because we'll have to expand our efforts to include not only GIs, but also endocrinologists and primary care physicians in the United States. Our commercial efforts are happening in parallel with our efforts to increase reimbursement.
If we go to the next slide, this outlines some of the key steps that we've already taken and what lies ahead as we pursue reimbursement. In Q2, two key developments were the publication of the PanFAM-1 data. What that data does is it helps us to reinforce the specificity of the IMMray PanCan-d test. Specificity is really crucial for payers in the United States because pancreatic cancer is a low incidence cancer. If you have too many false positive results, those false positive results lead to additional diagnostic steps that result in the payer incurring additional costs. That was an important step for us in further validating the use of IMMray PanCan-d in familial and hereditary risk groups.
As Philipp mentioned, we obtained the PLA code that makes it more straightforward for clinicians to bill for our test and allows us to work closely with payers to continue to secure coverage. In Q2, we have started to meet with payers, and our initial focus with payers is with commercial payers who tend to be more innovative. These are payers that tend to be more likely to cover tests like ours early in the process, as companies are continuing to build out the clinical data that supports the use of that test. We've had several of those conversations, including multiple conversations with the same payers, and are hopeful that that will lead to pilot programs, either late in Q4 or in Q1, where those payers will agree to use the test in their patient populations.
Many of those payers will provide reimbursement while those pilots are going on. Some of them also have a program called Coverage with Evidence Development. In those situations, payers will provide coverage while that study is going on, and then they'll use those study results to make long-term decisions about reimbursement of the test. As I mentioned earlier, one of our key activities in the second quarter was also working with advocates and KOLs who are using the test today, who are willing to talk with payers on our behalf. I've been very pleased as we were out talking with clinicians over the last few weeks. We had multiple clinicians that agreed to be advocates for us in conversations with payers in their marketplace.
We'll continue to work through those efforts with the goal of generating reimbursement for the test either in late 2022 or more likely in early 2023. With that, I'll transition back to Philipp for a wrap-up of our strategic priorities and execution against those.
Thank you very much, Jeff. I would like to close the loop and tie the progress also made in Q2 back to what I set out in February at my first quarterly call. On almost all strategic priorities, we've made significant progress over the last two quarters. I'm highly confident that we will further advance these priorities during the second half of this year. Making our test broadly available, ensuring increased adoption, and significant growth is what we are committed to do. We have today, and that I'm very confident of, the best team in place, the right strategy set, and momentum in execution. By being successful, we will not only address a huge unmet medical need, but also create significant value for our shareholders. With that, I would like to open the floor for questions.
We will now begin the question and answer session. Anyone who has a question may press star and one at this time. Once again, for questions, you can press star and one. There are no questions from the phone. Would you like to add any further comments?
Unless there are any questions which we're also happy to take bilaterally via our IR channel or subsequent to the call, I would like to again thank you for your interest in Immunovia, in our journey, and look very much forward pursuing our journey towards staying and building out our undisputed leadership position in pancreatic cancer early detection with you, and close the call with that. Thank you very much to everybody for joining us today.