Immunovia AB (publ) (IMMNOV) Earnings Call Transcript & Summary

Welcome and thank you for joining Immunovia's Investor Day. My name is Julie Silber, and I am the Investor Relations Director here at Immunovia, and I will be the moderator for today's event. Today's event is truly virtual with some of our presenters in Lund and some calling in from their home offices in the U.S. As a result, you may only see those who are in Lund, but you will see the slide deck from all of us. [Operator Instructions] Now I will take a moment to briefly remind everyone of our forward-looking statements, which can be found on our website as well. The following applies to this document, the oral presentation [Audio Gap] and any question-and-answer session that follows the oral presentation, collectively, the information. The information has been prepared and issued by the company solely for use of this presentation held by the company in relation to the company's operations and position. The information has not been independently verified and will not be updated. Unless otherwise stated and any market data used in the information is not attributed to a specific source, our estimates of the company and have not been identified, verified independently. The information included, but not limited to forward-looking statements applies only as of the date of this document and this presentation and is not intended to give any assurances as to future results. The company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Like I've mentioned at the beginning, a full copy of our forward-looking statements is available on our website. Earlier today, we issued a press release announcing newly adopted penetration ratios for our commercialized product, IMMray PanCan-d. This press release, like all others, is available on our website at immunovia.com under Investors under Press Releases and will be discussed later on in this webinar. We will begin today with an introduction by Immunovia's Founder and Chairman, Professor Carl Borrebaeck; and Mats Grahn, Immunovia's CEO. We will follow with the presentation on Immunovia's IMMray platform presented by Mats Grahn and then we will take a deep dive into our strategy for our marketing and sales plan with our Chief Commercial Officer, Laura Chirica; and then we will go into building our sales force with Michael Pettigrew, our VP of Sales, North America, followed by a discussion on the CLIA/CAP process with Dr. Thomas King, our Medical Director. Before then passing the presentation back to Mats for a summary, Tom will take us on a virtual tour of our Dx lab in Marlborough, Massachusetts. At that time, we'll open up for Q&A. I will host our Q&A session. [Operator Instructions] Now I have the honor to introduce our Founder and Chairman of the Board, Carl Borrebaeck, with our opening comments.

Okay. Good morning or good afternoon, depending on where you are in the world, and welcome to Immunovia's first Investor Day. My name is Carl Borrebaeck, I'm Professor and Chairman of the Board, and I welcome you all to this webinar. It's -- would have been nicer to meet you in person, but this is how it is these days. Today, I'm particularly proud that Immunovia has delivered or about to deliver an advanced test for pancreatic cancer in record time. This has never been done before, going from development to market in such a few years. And we're also committed to keep the speed with the fastest penetration for a diagnostic test. Why is this? Well, this is because pancreatic cancer is one of the deadliest diseases. And I think we have a moral obligation to provide our technology to the widest possible patient population as fast as possible. So our endgame is to become the dominant player in our multibillion-dollar market with Immunovia's first product and several more to come. So before we go into the business, I was asked to give a brief outline of what happened when we started the company. For those of you who haven't been hearing the story, don't worry, it won't be long. But we founded the company in 2007, myself and a few colleagues at the Cancer Research Center CREATE Health, here in Lund. But the story actually began already around 2000, where we had a vision to develop a test platform that would enable measuring the immune system's response to disease. There is so much information in blood, massive amounts, but nobody could, at that time, decipher it. So with a very nice funding from the Wallenberg Foundation, we basically turned every stone to get a good and robust technology that no one else has succeeded with. And I probably have -- I stopped counting around 6, 7 doctorial theses, but we have a massive amount of academic data supporting this. So after that, around 2006, we started with the clinical trials, and I think we probably performed at least 20 different trials for various cancer and cancer indications and other complex disease like rheumatoid arthritis, infectious disease and so on. And to make a long story short, this led to the successful development of the IMMray platform, which is our unique platform, which gives a snapshot of the immune system's response to disease, using a single drop of blood. Okay. So today, actually, IMMray is much more than a technology platform. It's a systematic approach to find the most relevant changes in blood and combining this knowledge into diseased fingerprints, also now as we call it, a biomarker signature. So from 2005 and forward until today, Immunovia has then developed this platform for early diagnosis in cancer. And as you might know, pancreatic cancer is the third most common cause of cancer death in the U.S. The 5-year survival is around 6%, 7%, 8%. But the interesting thing is that if we can find it early, which we can, at Stage 1 and Stage 2, it's resectable, and 5-year survival goes to 50%. That's an incredible opportunity for our patients to have this possibility of early testing. And while Immunovia were developing this test, they also did a remarkable job by industrializing the platform, setting up all the regulations, the Q&A for EU and U.S.-based regulations, starting a scalable production facility where we can produce hundreds of thousands of tests and also initiated 2 clinical laboratories, one in Lund and one in Marlborough, just outside Boston. And the whole sort of the end of all this is that we now have a test. We will launch it this year, and we will develop a lot of other tests for other indications. So all of this said, in 5, 6 years, we -- which is extremely fast, we have done something that nobody else has done, and we are ready for launch later this year. So I will leave the word to Mats, who will give you a few highlights over the last 3 years. And then we'll take it from there. Okay?

Thank you, Carl, and this is a great opportunity to have this webinar with all the investors and other interested people for us. There are so many milestones happened in Immunovia. So I'll just stick to the last 3 years. From 2017, we initially started our first prospective study, early in 2017, that was PanFAM for the familiar risk group, and that was followed by the PanDIA for the diagnostic 5-year new onset diabetics over 50, and lately also PanSYM for symptomatic patients. So we have now over 30 health care centers globally, leading ones working with us on these studies and also supporting us as key opinion leaders. 2017, we also started to establish Immunovia Inc. in Marlborough with our lab and market access functionality. And 2018, we completed the Dx Laboratories in Marlborough as well as building the one in Lund. These are -- we also completed a state-of-the-art production facility here in Lund. So we're really well off now when it comes to capacity to certify the market needs going forward. 2019, last summer, we got excellent results from the optimization study. And that was presented by Dr. Tom King that we'll hear from later today at the PancreasFest 2019, a big clinical event. There we show that we could differentiate pancreatic cancer from people who have symptoms that could have been cancer, but it's another disease as well as from diabetes patients and also healthy, of course. This was followed at the end of 2019 with the commercial test model study, where we confirmed the unmatched ability to early detection of pancreas cancer as well as showing robustness of the tests since the samples came from 8 different hospitals, which is a very important property in diagnostic tests. 2020, this year, despite all the extraordinary times with the COVID-19, we have managed really well to manage the restrictions that has followed that. And we are full steaming -- with full speed ahead towards launch of IMMray PanCan-d for the Quarter 4. And only a couple of weeks ago, on June 4, we did manage to make direct share issue, bringing in SEK 400 million, which gives us a fantastic financial strength now going into the commercialization. So with that, back to Carl for the final countdown.

Exactly. So thank you, Mats. It really gives me tremendous satisfaction. As you can hear, we're very proud of our company that see that all those years of hard work have come to the point where we now can help the patients in the clinic and bring it to other clinics and into society. That's really super cool, in my mind. And today, we are 60 employees. Tomorrow, we will be even more because we're setting up the sales and marketing team. Just by comparison, 2014, we were 3. So that's a tremendous journey, and I hope you all participate and will continue follow us over the years. So the final thing I want to say is that the take-home message is really that we will be the market leader in pancreatic cancer tests in a multibillion market for the years to come. That's the only thing you have to remember today. Thank you very much. I'll leave it now to Mats, again.

All right. Thanks, Carl. Let's get into the presentations and make sure you all have a complete picture of the company, where we're going, particularly now commercially. And let me say a few words first, why pancreas cancer for the ones who haven't been following us that long before. Early detection of pancreas cancer is the most unmet need in cancer really. Because today's situation is such that people who are getting diagnosed with pancreas cancer, over 80% of the cases is in a too-late stage, meaning that there is no possible treatment really, and it leads to death within a median 4 to 6 months. And the importance of early detection is undisputed. Because if you find it in Stage 1, if you're resection, you can -- current treatment, which is resection for surgery, you increase the survival rates from 5% to 8% up to 50%, which is a fantastic achievement with more than you can do with any drug. So moving into who are we going to test? There are 3 different risk situations. First of all is the people with close family relatives, familiar and/or genetic predisposition hereditary. These people run at a much higher risk than normal to get pancreatic cancer during their lifetime. And they needed to be tested ideally 2 times a year from middle age 45, 50 and lifelong. That's an important target, and they are very well-organized in patient organizations that we'll hear a lot about in this commercial presentation part. Then 10% of the people who get pancreatic cancer come from this group. So one has to address the sporadic ones as well, where you don't know why they get it. One thing is to really be able to do differential diagnosis of people who have symptoms being early and vague or later also clear. The need of a differential diagnosis is immense in the health care system. And our test can differentiate people with symptoms that have cancer versus people who have cancer -- do not have cancer but similar symptoms. So that's another important group or test situation. One other largest -- the very largest one is the new onset diabetics in this picture. People who are over 50 and get the first diagnosis of type 2 diabetes. And here, close to 1% will get a pancreas cancer diagnosis within 3 years after the diabetes diagnosis. It will be a huge advantage to test for pancreatic cancer already at the diabetes diagnosis, saving a lot of time, and in many cases, then finding the cancer in a stage where it is resectable. So these are the 3 ones we go for. Look at the market for this one -- with these ones. It adds up to over $4 billion only in U.S. and Europe. And that's what we're going for now as the first-to-market product. Initially, of course, the hereditary are very interested to get tested because they know and they're familiar. They know that they are at risk, and we will certainly help this group. That's 200,000 patients approximately Europe -- in Europe and U.S., and they are either in screenings where our test will be needed or they have no solution whatsoever today. So the market for that is about $240 million. And then moving to differential diagnosis. We estimate that there is a need for about 1 million tests in the health care systems today, gastro centers and also in health care centers that are trying to move this out to the primary care. And then last time -- last group, the new onset diabetics. Only in U.S., you have 1.25 million new patients every year. Adding the ones in Europe means there's more than 3 million new people every year that get a diabetes diagnosis. And they should ideally be tested at least 1 test per year for 2 years minimum. And that means a market of $3.6 billion going forward. In total $4 billion market, where there is no solution today. And that's what we provide. So our test, how to use it in a lab? It's a simple standard blood test that we then treat with fluorescent marker for the blood and place on the product, which you see in the middle here, the black square, where the antibodies are printed on surface. And we will show you how they're produced and how it's used in the lab and it will be used during this presentation. The slide is -- after the blood has been applied to it, red with a fluorescent scanner, laser scanner and the picture is interpreted by our bio informatics algorithms that reside in the cloud and the results sent back to the lab and then further to the clinician and patient. And it's a -- you have cancer -- we have no cancer results. It's very, very actionable for the clinicians. I have been asked a lot about our patent portfolio. We have a very strong patent portfolio for the pancreas area. We have patent portfolio in other areas as well, but this is the key ones now for these important products. The earliest one is filed already 2008. And then we have step-by-step with every discovery study and development study, got more information that enabled us to strengthen and broaden the patents and protect them in different ways. And also on purpose, of course, we want to have the most important patent, which is going on right now, we will file in a few weeks only that covers the product for the coming 20 years. So it's a very strong patent portfolio for pancreas cancer. And as you see, the last one will be the one that really takes us 20 years ahead in terms of protection for signatures in blood with measuring proteins. So with that, I would like to show you a short slide. How do we produce these ones? Because this is also a competitive advantage. We have a huge capacity in producing these slides that you saw with the printed antibodies on. And there are 2 steps in producing the product. One is to actually produce the antibodies themselves, which I won't show today. But I will show how we actually print these antibodies on the surface that forms the slide that is later used in the lab. So this is an extreme miniaturization and -- sorry, I'll start the video here. Here we go. Right. So the robot picks up the antibodies from their storage place here. It goes out to a quality check station with extreme precision and miniaturization of the whole process here. And it's fully automated, and we can print, as you will see very soon here, 84 spots, each spot being run antibody for 2 seconds. Now it's printing a whole slide with 84 spots there from there to there. So it's doing slide by slide by slide. And the total capacity of one of these production robots is 120,000 tests per year. And we have 2 of them right now. We can easily roll in many more as demand grows. So current capacity, 240,000 tests per year. We can, in a very short time period, build up easily well above 1 million tests a year in the current facilities. So that is extremely well prepared. Right. So summarizing this introduction to what we are and where we are? As Carl said, our vision is to be the dominant player when it comes to pancreas cancer diagnostics. And we really have a great position of being first to market to a $4 billion U.S. market. We have a fully funded commercial rollout with the latest funding we did. And as we have released this morning in a press release, our long-term target is a 30% market share moving forward. And to achieve this, we have to have a really well-thought-through commercial program rolling it out. And I will leave the word to Laura Chirica, who is our Chief Commercial Officer, to take you through that.

So thank you very much. First of all, thank you, Julie and Carl and also Mats. And actually, I would like to thank you all of you because you are joining us today. I will start by pronouncing my name the right way because you've heard it in all different ways, and you should know it. So it's Laura Chirica. And as we have a packed program, I will get started right away. But I'm going to give you some minutes to drink your coffee. So before describing for you the commercial programs that we have been developing and implementing here in Immunovia during the last 5 years, I will just give you a short introduction of myself. I was just thinking how should I define my career just in 3 words. And I came to 3 words: global commercial strategies. And when I say global, I also mean living and also managing our people in different countries in Europe, living in the U.S. and also managing teams in Asia. What I should also add to here is the fact that I have been working with everything, for example, in the laboratory products and kits for proteomics. We were commercializing and creating strategies for hardware. software and integrated solutions. I have been working with bioprocess industrial platforms, commercializing those to pharma. And also, last but not least, I would like to give the fact that I have been managing sales and marketing for tests and services -- testing services for diagnostics for autoimmune diseases and cancer also through a private lab that was extremely successful globally here in Sweden. I would like to end, it was Carl who was talking about this, and I would like to really reiterate that. I feel privileged to be part of Immunovia's journey, and I've been here for the last 5 years, which have been the most interesting and exciting in my entire life. Now I am going to go through the commercial programs, as we have discussed. But before that, I just want to put everything in a time line perspective, so you are well equipped when I'm going to get started. And then you have to hold on because we will go through quite many different initiatives. We have been now entering the final stages of validation for IMMray PanCan-d. And we are actually going to mark a historical event when we will launch in Q4, the first-in-class test for early detection of pancreatic cancer. You will find out that pancreatic cancer, as Carl mentioned, being the deadliest disease by mortality hasn't seen a change since the last 30 years. Then we are also working in the meantime with the necessary accreditations for -- both for our company and also in Lund and also for our commercial laboratories in Marlborough and also in Lund. These accreditations are important for us to be able to start our self-pay sales directly at launch. I will also talk a little bit more in detail in some slides about our clinical studies program, which is extremely important for our reimbursement. So now let's go through the road to market and our main programs. I will present for you the highlights of each of these programs. I will cover today 5 of them, and I will give the word, as I come to the last 2 ones, to my colleague from North America sales, Mike, who is going to take you through the sales strategies. And also then, Dr. Tom King, our Clinical Medical Director, who will talk about our Immunovia Dx Laboratories in Marlborough and the processes to launch there. So in the middle here, you find the spider in this net, which is also so nicely called the Key Opinion Leader Program. It is one of the most essential parts of commercialization of this kind, in general also. But for us, for bringing to the market a revolutionizing technology and test, it is absolutely essential to have the key opinion leaders that are the ones who will help you to both implement this test and this technology into the clinical routine and also change the guidelines, which is extremely important to, in the end, reach reimbursement. If we then have a look at where we are right now, think about that this was the absolute first program we started 5 years ago. And we are really happy, grateful that we have the world's largest Key Opinion Leader network in the U.S. and Europe. And I don't expect you to read through all these names right now. But if you do, you will find out that we really do have the absolute most renowned names that are in the field of pancreatology, pancreatic cancer and pancreatic diseases. And they are the authors of both national and international guidelines for pancreatic diseases and patient management and treatment. So you will also find the very close connection to our clinical studies program. And you have heard also Mats talking about our risk groups. And I'm also going to show you one other approach of looking at how we have been designing these programs in collaboration with the Key Opinion Leaders to reach those clinical evidence data that is necessary for the reimbursement. And we call it so nicely in marketing where we have all kinds of terms' positioning, in fact, is where our test is going to be used alongside the progression of pancreatic cancer. If we look at a very typical schematic of the disease progression, it starts as in any cancer with the asymptomatic part, which is, in this case, also called the familiar hereditary pancreatic cancer, and I show you just in a minute, then it's moving into an early symptoms that are coming through the primary care evaluation. And those symptoms are also called concerning or alarming symptoms, suggestive of pancreatic cancer. And then they move with a positive imaging referral to the gastroenterologists that are doing the whole investigation of the patient. And it's actually also a part that is recurring or large part of this pancreatic cancer is recurring, and they are also followed at the same gastroenterology clinics. So our test is suitable to be used for surveillance programs of the familial hereditary individuals that are in the national screening programs or outside. Then moving along also as an aid in diagnosis for the primary care evaluation. And also, as Mats was mentioning earlier, there are enormous opportunities for differential diagnosis, which is one of the biggest needs, which is also called confirmatory diagnosis in the gastro clinics. Our clinical studies are built alongside to provide the clinical evidence. And here, you will find them under the name of PanFAM from familial pancreatic cancer hereditary risk than the symptomatic group. And also the -- one of the main early symptoms of pancreatic cancer is new onset diabetes after the age of 50. And here, we are also driving a large study, which is called PanDIA. If we now overlap the Key Opinion Leader Program that you saw earlier and you put it on top of this map, you will find that here you find the majority of our collaborating sites that are working together with us, recruiting now more than 10,000 subjects in these 3 major risk groups for pancreatic cancer. And they are the ones that we are working intensively, and we are adding to this group all the time. Now let's have a look at the road to reimbursement. And of course, this is multiple process of several steps and several processes involved because we are looking at both private, public. We have a number of prioritized geographies. I'm going to show you that in just a minute. But I think it's very good to have one time line overview, a snapshot at where we are with the reimbursement. And we have been focusing quite a lot on establishing this program. We have worked with guidance experts around the world to develop health economy models for the different national systems that are part of the reimbursement process. We have established payer interactions, and we are going to intensify this payer engagement with the interim analysis, the interim readout from our prospective studies. And then this will, of course, lead to the final readout and the final reimbursement process in 2023. I will shift gears now for the next program because it's a very interesting, powerful part of Immunovia's commercialization and communication. It is the patient organizations. And I want to say that I have never been closer to the patient as I am now. It is of the nature of this disease, the development of it, the way the people are actually passing away in only 5 months after the diagnosis. This is creating kind of a need in the survivors and in the family members that are then deciding to dedicate their lives for fighting for -- against pancreatic cancer and also to raise awareness for this dreadful disease and also bring money to the research to move this forward. And in this context, we have been also collaborating with a very large number of patient organizations, and we have very close relations with them. I would like to mention here World Pancreatic Cancer Coalition, which is having actually 80-patient organization members from 30 countries from 6 continents. We are sponsor and a member of World Pancreatic Cancer Coalition. And also, I think it's interesting to mention the most powerful organization, which is the Pancreatic Cancer Action Network, PanCAN in the U.S., which has more than 100 people working full time with supporting the patients. And also the other very powerful organization, Lustgarten Foundation, from the U.S. that is dedicated to providing money for research. Both of them, we have been collaborating with and probably the ones who have followed us have seen that we were part of sponsoring their works. And in this way, getting contact with over 50,000 people interested to get into the early detection of pancreatic cancer. Then I will move to the European side, and I will also mention 2. One is PALEMA from Sweden. When we started 2015, there were 5, a handful of members. Now they are 500 and growing. And the last one I wanted to mention is an amazing inspiring person. She is called Ali Stunt, and she is the President of the Pancreatic Cancer Action. U.K., is a 13-year survival -- or survivor of pancreatic cancer, who is one of the most interesting influencer. She is lobbying in the Parliament. She's sitting at the BBC News and morning shows and radio. And she's absolutely burning to make a difference in pancreatic cancer. We have been collaborating with her since the very beginning, and we are very grateful for this collaboration. So we have come to the heart of any commercialization, marketing and communication, or I should say something else. One of my sales directors was telling me that marketing is like the neck and sales is like the head. So the neck is telling what the head to do. And I agree with my colleague. So we have been working extremely much with marketing and communication. And now we have actually transferred all the market access activities into a launch project, right, a launch program. And when you say launch, I don't know what it tells you. But when we are talking about launch in our field, it's actually not a rocket launch, it's a sum of a number of parallel activities and deliverables that are coordinated to provide the information to communicate, to convince our target groups that we have a test that is actually answering to their needs and the way to order it. So this is what we have now put together into a digital launch plan that I'm going to give you some highlights about. Before that, I want to actually say to Carl that there is one more take-home message than the one you said, which is that I want all of you to remember, our primary message for the launch of IMMray PanCan-d is that early diagnosis saves lives. And also, as you've heard, with the use of IMMray PanCan-d, we are giving the clinician the possibility to intervene earlier in the early stages of the disease when operation is and treatment are still possible, in this way, increasing the -- both the life quality of the patients, their families and also the 5-year survival rates up to 50%. Who do we need to convince? Who do we need to communicate? Who do we need to bring the test to? We have been mapping the diagnostic clinical routine for -- based on actually all the different guidelines that are around. And this is, let's call it, a sum of all these different guidelines. And here, we can see that the early detection targets, they are the patients and, of course, their families that are in familiar surveillance; the primary care physicians, the general practitioners that are seeing the symptomatic patients and the new onset diabetes risk groups; the genetic counselor that are assessing the asymptomatic familial surveillance members for the programs; the gastroenterologists where the patients get referred; and last but not least, an extremely important part, which are the surgeons. So we have built our virtual, our digital launch plan to reach these PDAC risk groups and the clinicians. We have 6 components of this plan, and I'm just going to take you through from the top around the clock, just give you the most important highlights. And if we start from the top, here you get a, what I would call, a prelaunch of our virtual walk event, which we call around the world for awareness of pancreatic cancer. We are going to walk together to bring, of course, awareness of pancreatic cancer, but also through this, awareness about the availability and the launch of our test in Q4 this year. What we do, in fact, we are going to cover together the circumference of the world. So walk around the world, which is 40,075 kilometers. It will start from 19th of July. So that is when you will have opened the registration. We will give you the details, Julie will, through 19th of November, which is the World Pancreatic Cancer Day. And we would very much encourage you to participate and to be part of this, I say, united initiative that we would like to absolutely succeed with. If we look on the other side of the virtual events, we find the clinical events, which are, of course, as important to reach our clinicians. And I will only highlight one event, which is just in 2 days. European Pancreatic Club, one of the most important conferences for pancreatologists, not only in Europe but worldwide, has gone digital, and we are going to host a symposium. Dr. King is going to give a presentation, announcing Imma -- both the latest results and our launch, and we are extremely happy to have this opportunity. Coming to the next point, I would like to tell you that this is actually a very -- let's say, I don't call it old because we are all young, but it's a classical sales leads generator event, which, in all times, we were renting a bus, and we were going. So it's a roadshow. Now with -- given the situation that we have around us, that's not possible. So we are going to organize virtual meetings, and we are going to have a virtual bus that is going to take us to these places. And this is an extremely good event because it's done through our Key Opinion Leader network and with their help and their championship. And in this way, we are going to create sales leads, support our sales team at targeted priority hospitals. Digital communication is something that you probably hear, I don't know how many times, it's a buzzword that everybody is using. And of course, it's very important in these days. We are going to create the, let's say, most relevant targeted tools to create awareness, and we will work with our target audience, the channels, the online channels that they are using. And we will create podcasts, interviews. We have also to work together with online TV and radio, and we will also have online advertising. And around online advertising, I just want to again give you a prelaunch of what we are working there. And it's an awareness of our launch, and it will answer the question, what does early detection mean for you, which is a fundamental question for our target group. And here, we will get the answers from the patients, their families and the clinicians. And we will then distribute it into all our online channels. I think Carl was mentioning that we are going to welcome our first field sales managers that are coming in tomorrow. So because of this, we have created an extensive sales force program for them to both educate them in sales online and also to equip them with the best tools. And as we are getting closer and closer and closer to sales and giving the word to Mike, we are really happy and pleased that we are having now also the sales joining us. And I'm going to end our digital marketing launch plan with our launch day, for which we will mark with a live stream digital launch event. And we are going to have these talks and interviews from a large number of our survivors, Key Opinion Leaders and, of course, Immunovia. Before giving the word to Mike, I would just like to say a few words about our launch and commercialization priorities. And here, you will see that we are going to go to the market in 2 waves. First wave is the U.S. commercialization in Q4 2020 that will then be followed tightly by the second wave, the European commercialization. And in dark blue here, you see the U.S. and Sweden and Nordic because these are, of course, our commercial laboratories and our, let's say, the home market and the largest market. And then I would like also to say that we have been working extremely intensively during the last years to establish, and we managed to establish ourselves, in the U.K., in Spain, Italy, Germany, Switzerland, Austria, and we are in the process of building up Benelux, France and Canada. So I hope you are as excited as I am and as my colleagues are. And I am very happy to give the virtual stage to Mike Pettigrew that will take us through the sales strategies for U.S. Thank you for your attention.

Thank you very much, Laura. One more slide, please. Thanks, again, Laura. Laura and her team have done a fantastic job getting us to this point. And like the prior speakers, I'm very pleased to be part of Immunovia. And it's an exciting time moving towards commercialization. And as Laura suggested, kind of a milestone tomorrow as we bring our first salespeople on board. So what I'll walk you through today is I'll go through a brief background of myself. I'll talk a little bit about how we're developing our sales strategies, customers that we're targeting, how we're going about developing our sales territories and then next steps moving forward. Just quickly about myself. I've been in the industry for over 30 years. Post university, I started commercial career in field sales with a company called [ Pharmacy of Biotech ], which is now Cytiva after acquisition of -- by GE Healthcare and now is part of Danaher. I had a number of commercial positions there in sales and marketing. And a few highlights there. I was involved in commercializing a platform of chromatography systems called ÄKTA. They're now kind of the world-leading purification systems in -- for [ approaching ] purification, that was kind of a great experience working on a platform, much like we're doing here in Immunovia. I then moved over to the genomics business, and I was involved in the commercialization and launch of capillary DNA sequencers during the human genome project. And we sold both into the research and clinical communities to companies like Myriad Genetics, CuraGen, et cetera. From there, I went to a small management team and did some M&A work. And then moved on to a company called Dionex, which was then acquired by Thermo Fisher. And my last job there prior to joining Immunovia, I had responsibility for the Americas commercial organization with sales, marketing, customer support, technical support. We ran several laboratories there as well. It was north of $500 million in turnover and roughly about 400 people in size. So I would say to kind of sums up my background there, a lot on the commercial side, a lot of experience in developing sales organizations and a lot of experience in product launch. Next slide, please, Laura. Thank you. There are roughly over 800,000 physicians in the U.S. And I love this slide because it really helps us understand, as a sales organization, who we're going to target and how we're going to interact. I think this is a great depiction of how patients enter into the clinical community from several different potential places and again, clinicians that will work with those patients. One of the bigger groups is primary care physicians. There's over 180,000 of those in the U.S. As Laura suggested, her marketing team has already started working with this group. And we will work with this group as well as leads come in as they order tests and they need education about our platform, we'll clearly respond to them. However, that won't be a major target group for us. The major target group will be gastroenterologists. I think Mats and Laura both spoke about early symptomatic patients, new onset diabetes and the size of the market there. Many of those will end up in the gastroenterologist office either directly or through referral from primary care physicians. We also feel that patients with hereditary issues and familial patterns will also end up in the gastroenterology group for a diagnosis and eventual treatment. So this will be a key group to us, and you'll see a little further on in the presentation how we're going to target that group and how we're using some of our tools like customer relationship management system to help us through that. Genetic counselors are an important group -- I'm sorry, back one slide, Laura. Genetic counselors are also an important group because of, again, the familiar inheritance pattern. They've also spent their career in molecular medicine and are very familiar with biomarker and DNA testing. And not only will they help the patients by coming into this process, they'll also be a reference for the other clinical groups in here. And Laura spoke about the pancreatic surgeon group. A lot of our Key Opinion Leaders come from this group. We're very familiar working with these individuals, whether they be specialists or surgeons in this area. This will be a key target group for us as well. And in my opinion, this may be the first group of initial users of the IMMray platform for differential diagnosis and, again, confirmation of a disease. These will also become Key Opinion Leaders within their communities for us and very important for us as we commercialize our test. Next slide, please, Laura. There's a huge amount of geography in the U.S. And after we've found a way to target our clinical customers, we have to find a way to break in -- break the geography into territories and manage that via our sales organization. Here, you see kind of the eastern seaboard of the U.S. There's roughly 120 million people represented in the eastern seaboard. Many of them are focused around large metropolitan areas, Austin, New York, Philadelphia, Raleigh-Durham and kind of now an aging population moving into Florida, which is in territory 4 depicted here on this map. You can see gastroenterologists are a key target group for us. And we've identified a number of gastroenterologists in each one of these territories that we'll be targeting. That information already resides in our customer relationship management system, our CRM. And this will help our salespeople as they come on board, get a head start as they take a deeper dive into those territories, as I'll talk about a little bit later. Something else you see on this slide here are multidisciplinary GI centers. This is kind of a new and growing trend in the United States, where you have groups of clinicians that are getting together, multiple gastroenterologists, oncologists, geneticists. Normally, they're around larger hospitals that have access to diagnostic imaging and equipment, and they take a more holistic approach to a patient, kind of bridging the gap between screening, diagnosis and therapy. This is a key and critical group to us, and I think the IMMray platform fits very well with them. And again, I think this will be a group that will not only target, but it's likely to be early adopters of our technology as well. Next slide, please, Laura. Kind of another approach we can take here, and this is very specific to pancreatic cancer. There are a number of centers you can see that are depicted here that have been accredited as pancreatic cancer centers by the National Pancreas Foundation. It's a non-for-profit group. They've set out a number of different criteria to become a National Pancreatic Center. It's kind of, again, a holistic approach to the treatment of a patient. So as the patient enters one of these facilities for diagnosis and treatment, they will be given a program director that will help them navigate through the series of specialists and diagnostic therapeutic treatments that we'll be dealing with. Also to become one of these facilities, you have to have a minimum of 2 medical oncologists onboard that have experience in treating pancreatic abnormities and issues, including pancreatic cancer and other hepatobiliary malignancies. Also, there has to be a diagnostic radiologist on board that has experience in the diagnosis of pancreatic diseases. And you also have to have a minimum of 2 pancreatic hepatobiliary surgeons on board, and they've had to perform at least 20-or-more resections in the past 2 years to have this accreditation. With something so specific that the pancreatic cancer, again, these will be key target groups for us. All of the key target clinical groups reside in these facilities, genetic counselors, gastroenterologists and pancreatic surgeons. This will be an initial group we'll target. Again, we've already populated our CRM with many of these facilities and the individuals in that. And as our salespeople come on board, they will refine these approaches. I also feel this group will be an early indicator of the success of the IMMray platform. Next slide, please, Laura. Now as Laura suggested, we're very excited to have our first 2 salespeople join us tomorrow, and they will continue to refine our approach. This is looking at one individual territory. So we've looked at the broader group of clinicians. We've looked at pancreatic centers and some GI centers that we want to target. Now we want to get down into really kind of how we will manage a territory and where we will focus there. There's over 7,000 hospitals in the U.S., and there's hundreds of hospitals in any given region. However, any -- the majority of clinicians that are dealing with diagnosis and treatment of pancreatic cancer reside in many of the larger hospitals that you see depicted here and also individuals from these areas that have -- that are in one of the higher risk groups, tend to gravitate towards these hospitals for diagnosis and treatment. So you can see here some of the major hospitals. If you look at the Boston area, Beth Israel Deaconess, Brigham and Women's Hospital, Mass General, these are very large hospitals with large staffs. They also have many of these GI centers and other holistic approaches in the area. So these will be areas that we will target right away. And our salespeople will now go in to our CRM, and we will start to look at individuals that we will target in these hospitals. Next slide, Laura. As you can see, Mass General is one of the larger hospitals, and this is just kind of a cut out of the potential clinical providers that we will be interacting with as we start to educate community on the IMMray platform and the benefits of the test. Our sales team will now go in, look at our focuses. We know we're going to have to focus on gastroenterologists and geneticists and pancreatic specialists. We will overlay that on kind of the individuals in these different clinical functions that you see on the left-hand side. And we will now begin to target those, and we will develop a list of individual physicians that we will enter into our CRM, and we will target through our sales and marketing efforts. Next slide, please, Laura, I mean, here, you can see kind of a really interesting cut for us as you can go into a place like Mass General and look at all of the individual clinical physicians that are dealing with disorders of the pancreas. There are roughly 44 individual specialties that you see here. There are approximately 30 specialists that focus in these areas. These fall into that kind of pancreatic surgeon and specialist group that we're talking about. These will be key to our success, and there will also be a kind of early adopters to the IMMray platform. We're very used to dealing with these individuals already. Like Laura suggested, these fall into kind of similar patterns to our key opinion network. And these, we will focus on heavily in the beginning of our sales process, and that will become a reference base for us moving forward. Next slide, please. So kind of next steps moving forward. I've given you kind of a high-level background of how we will segment our market by clinical specialty, by geography, our salespeople will come now in and define that approach. But one of the key things that we will implement, we're in the process of executing now is our customer relationship management system. It's critical for 2 major reasons. One is, we're taking a fully integrated approach where all the interactions from our clinical customer base from the time the clinician orders a test all the way through to the delivery of the results of that test will be archived and memorialized in this system. So it's a one place to go for us to deal with the entire process that we will be working with, with the clinical community. But from a sales and marketing perspective, this is also a place where we can archive and memorialize our interactions with the clinical community. We will use it to segment our customer base and target our customer base, as I had suggested earlier in the system. And we will use this system also to monitor our demographics make sure we're targeting the right individuals and track that over time. The really key to using a customer relationship management system in a good way is to use that data that we're collecting to make informed decisions and -- informed decisions. And that's how the sales and marketing team will be using this here as well. We're also going to take an approach where we're going to hire both field sales representatives and inside sales support. The field team will be calling on the clinical community in the territories, as I have described before. The inside sales team will support those field sales effort. They will also take incoming calls, send out information to the clinical community and cover regions of the country that may not have a salesperson in them at any given time. Next slide, please. And this is kind of our plan to roll out in a stepwise fashion. We're going to start on the Eastern seaboard because of the density of the population, the availability of the -- our target clinical community. We will, again, start with our first 2 field salespeople tomorrow. We're having great success in recruiting for these territories. We -- our first 2 candidates have a great background in the industry, and we're getting quite a bit of interest for the other territories as well. You can also see a stepwise fashion here as we would roll out more territories across the U.S. in the same fashion we did for the first territories, as I've described. And we can move very quickly now as we have this model that we can use to hire and fill these territories and populate our CRM with information, and we now have the financial backing to do that. So I look forward to the launch and the commercialization, and I'm very excited at building this team, filling it out and managing the launch in the U.S., along with Laura and her marketing team. And I think with that, I'll turn it over to Tom.

Thank you, Mike. I'm Dr. Tom King, and I'm the Medical Director of Immunovia's Clinical Laboratory in the U.S. Next slide, Laura. Today, I want to tell you a bit about my background and experience and then walk you through the final steps in our preparation for the clinical launch of Immunovia's first-in-class test for the early detection of pancreatic cancer. First, I want to tell you a bit about my background. I'm a board-certified pathologist and have been practicing in the United States for over 30 years, primarily as a laboratory director at academic medical centers, private hospitals and in biopharma. In those roles, I have developed and introduced many laboratory developed tests, similar to our plan for the launch of our IMMray test for pancreatic cancer. I have also been a fellow and laboratory inspector for the College of American Pathologists for many years. The college is the premier accrediting body for clinical laboratories in the U.S. and their accreditation will be very important for us to sell effectively to gastroenterologists and other pancreatic cancer specialists. As Mike highlighted, this group is very important to us to introduce the test and to broaden its appeal to other clinicians. Next slide, Laura. Our U.S. laboratory is now well-established in Marlborough, Massachusetts, with a strong physical and information technology infrastructure that will support the launch of Immunovia's first-in-class IMMray pancreatic cancer test. We are now performing parallel testing with the Lund laboratory and are awaiting the completion of the Lund verification study in Q3 of this year. Once this verification study is complete, we will begin our own blind validation study, paving the way for us to apply for Massachusetts State Licensure and CLIA accreditation. This step is required before we can begin patient testing in Q4. I've worked with several Massachusetts laboratory inspectors as director of different clinical laboratories over the years and really anticipate no problems with this step. This is more a formality, but it's required for us to be able to start patient testing. Once that's done, we will be able to apply for College of American Pathologists Accreditation. And we would expect an inspection visit from them in about 6 months, so in 2021. This inspection will be quite in depth, but I expect it to really pose no difficulties for us as I've led many laboratory inspections for the college during my career. Given that, I want now to invite you to take a virtual tour of our Immunovia Dx laboratories in the U.S. and give you a preview of how our first-in-class IMMray test for the early detection of pancreatic cancer is going to be performed. And we can go ahead and begin the video. You can see we're walking into the laboratory here. Here, you can see [ Jana ] is unpacking a NanoCool container, which is our custom shipper to maintain [Audio Gap]

Okay. And that was a possibility to make a virtual tour of the lab in Marlborough. We have a similar lab, of course, here in Lund as well. And when the corona problems are over, I hope that many of you can come here and have a look at it in real-life as well. So to summarize this, we have a fantastic team in place to bring the test to market. Our vision is to dominate the pancreas cancer market. We are first to USD 4 billion market that we are well financed now for the commercial rollout. And we have all the capabilities to handle and target a 30% market share long-term here, which is really dominating the pancreas cancer opportunity moving forward. So thanks for listening. I hope you got an in-depth picture of what we are going to do and what we are doing and the fantastic opportunity that this provides for us. So with that, we're moving over to the question-and-answer session.

Thank you, Mats. While we queue our questions here, I would like to bring up all our presenters to be on hand to answer questions. [Operator Instructions] But I also have some questions that were sent in earlier. And I am going to start asking. So here we go. The first one is about our lung cancer press release that came out earlier last week. And the question is, why did we not add the percentage of accuracy in the press release?

Well, we are in a discovery phase with this one. I actually have a slide showing this that I could show to you, which we have also put as a part of that press release. Tests, these are developed in two stages: discovery stage, which is step one through 5 in this stair from start to finish of a new product. And that is an iterative process where you run a study, you learn or get data that helps you to define the next step in the process of getting to a stage where it is in a state where you can move into invest in the final large costing development studies to market introduction, including prospective studies. So in all clinical, discovery processes, you don't release data on iterative steps because they move step-by-step towards a goal, and that would be rather confusing and also misleading. So we have great results that allow us to invest more. We have financing to allow us to invest more, and we are now going to run a larger -- significant larger study with also a higher number of early samples that would take us a significant step forward towards a position where we hopefully can move into development. So that's why.

Great. Thanks, Mats. We have another question on the commercial test model study. So it's just a big comment that there has been some criticism about our transparency that we have not yet received any detailed figures about the commercial test model study, and that this is motivated by patents pending.

True.

But why are jeopardizing the patents by just showing performance figures?

We are not jeopardizing. That's the whole reason why we have not released the very detailed data yet is to make sure that this patent is as broad as it can be, and it will be very, very important for us, as I mentioned before, going forward. We also have to generate additional data that doesn't have to do with the performance of the test, but that strengthens the patents. And that work has been ongoing in parallel to all the development here. So we are in the final weeks of finalizing this now. And of course, you have to -- I think everybody understands that the final patent that is the strongest one and covers the product for 20 years has to be done as broad and deep as it can be. It's crucial for the long-term value of the company. As soon as that has been done within the coming few weeks, we will also run webinars with the information that then is more detailed. But as we have released already, it is confirming the excellent data we had from the optimization studies. And on top of that, giving us confidence and data showing robustness of the test from different hospitals. So it's a very strong package that's been put together.

Great. Thanks, Mats. The next question is about our press release that went out this morning on the penetration ratio. Could you give some further granularity on when we expect or when you expect to reach 30% market share within the 3 target groups in the U.S.?

Well, this is a long-term target, 30%, and that will be dependent on how well we execute and how well it's received for the reimbursement and prospective status and so forth. So of course, that's the target. We have a fantastic position to go for it from here. But giving exact times is not what we do to a long-term target now.

Can you reconfirm the existing revenue guidance for the coming year?

Yes, that is our target.

Great. So another question on another side. This is more towards the sales side. What precisely are the financial incentives for a medical doctor to recommend or prescribe the test?

Any comments there from the marketing and so forth, we'll think about it? I mean their incentive is, of course, to improve the clinical situation. And they have a desperate situation today because 80% are the ones they see are not treatable at all, and therefore, they're dying. Will they earn money? And it -- well, there's not an obstacle that we are replacing something that the early money -- that's been an obstacle in some other instances. I think that may be what the person asking the question are referring to. If you have a current diagnostics situation where there is a tool or a procedure that's used by a clinician and that they get reimbursed for or get paid for and then you come and make that unnecessary. And then you have a situation that they may refer for. In our case, that is not the case at all because there is no solution at all. It's not a competition to imaging at all. Imaging is there, but is needed and they are overwhelmed. They cannot do what we can do with a simple blood test. So there is no financial loss at all for the clinicians, only a gain in being more efficient, treating more patients more correctly and moving forward. So in that sense, it probably translates to a health care economic gain as well, both on the individual level and on the health care systems level. Laura...

Also, what we are calling and working with the clinicians is the possibility for accelerated diagnosis, which is what we are saying efficient because in this way, we are going to get to the diagnostic answer much faster by using our test. And yes, it may mean that we are -- and this is what we are proving with our studies that we are actually able to get to the diagnoses in a much faster way than it is possible today.

Thereby, they can treat more patients within the same cost frame, hence a better financial situation for the health care system and the individual clinicians. Okay?

Yes, absolutely. So we have a question here on how does it work, okay? I'll explain a little bit more.

Okay.

When an individual, not a doctor, but when an individual is probably someone under the familial headline wants to get the test, how do they go about doing that? And how many can they order?

Yes. That's a really important question because that's one of the key elements in our market preparations and the launch plans here, and that is make it very easy for the risk person in this case to get the information written or digital that he needs to convince his clinician, his primary care clinician probably in the most instances in that case. So we have put that together and we will make it available through our website, of course, but also create awareness through the patient organizations and all the channels that Laura went through. The next step is to make it really, really easy for the primary care clinician to order the test. So we have worked with the primary care organizations to define the requisition forms and the supporting material that will come with this. So the only thing that really need to do, the primary care clinician is to sign the requisition and send it into us. We will also take care of the practicality of blood sampling through our system we built up with even home phlebotomy -- home, getting the blood sample, taking it U.S. maybe not so in Northern Europe, that many primary caregiver do not have the facilities to draw blood. So we handle that as well. So the key is to make it convenient and easy both for the person to convince their clinician and also make it easy for the clinician to order and to only have to deal with placing the order and getting the results back from us.

And also this generates the billing, which is also a very important part that is included in this whole process for the patients having an easier possibility

Yes. True, the payment side, yes.

Yes.

Great. So we have a question regarding sort of the U.S. sales organization. At what level of sales, meaning number of tests or dollars would a sales rep become profitable? Have we done that calculation?

Well, Mike, you want to comment on that?

Yes. We really haven't done that calculation yet. However, it's an important one. And as we work through the full commercialization, we do understand kind of the cost that we need to support the sales and marketing efforts. We understand the cost of the test. And I think it's a fair question that we really just haven't gone around doing the math yet, but we will.

Yes. But it's also an important thing to understand that the task of the sales force is to build up a repetitive sales from the customers they approach. So once you have got a gastro department and the key clinicians there to use the test, initially, they will try it out. They will order for a number of patients and so forth. But the task for the sales person to make it a standard procedure. And thereby, you get a very interesting stream of tests with little sales interaction compared to the initial step in the beginning. That's an important aspect, of course. Volume is -- this is a volume business. The profitability goes up dramatically with volume really, really much.

But it's also a process that develops over time.

Exactly. That's what it is. That's why we have a sales force to get it going. Otherwise, it won't happen.

Great. Thank you. Okay. We have a question related to the COVID-19 global pandemic. And the question is, is there any residual issues or news or delays that we might have to deal with now that things in the U.S. are maybe not as under control as they were?

Yes. U.S. is a huge country. And initially, the area where we are located, the East Coast, Boston area, was together with New York hit very hard. That's why the lab was closed and then the whole state was closed. That's opened, and we are fully operational. So that's fine. And I think the situation is improving very rapidly in this area of the country. It's not improving at all in other areas such as Florida or Texas and these ones. So they are going for their peak, I would say. So as you saw, our focus is the East Coast first. And therefore, I would say, we don't -- since we now managed to get through the very hard months of March, April there and into May with actually very little delays, given all the work we did and moving things back and forth and so forth, I think we are in a very good position. And I think also the states on the East Coast know how to handle the situation in a similar way as the Europeans have learned the hard way. The other states in the South and Midwest and so forth where there is now increasing, that will take some time, but it doesn't affect our plans, I would say. So unless there is a huge second wave in the East Coast, I think we will not be affected.

Great. Thank you. So we're back on the penetration ratio. Okay. With the 30% market penetration figure, how did you arrive at that level? Why is it not higher? Could it have been lower? Is this penetration for just the U.S.? If you can give a little more detail?

No, this is for the market that we have looked upon here, the Europe and U.S. market. And U.S. is a huge country. It's a huge opportunity. And once you succeed and when you do first, you have a fantastic opportunity, as you -- I guess, many of you have seen on in colorectal cancer. However, of course, if you look upon their figures, it took, I think, 5 years after launch and reimbursement to get to 5% of their enormous market, which is 106 million people. But we have advantages in terms of percentage penetration of those market is in number of people eligible is smaller. Advantage is they have a very well-defined target and risk groups. We have a fantastic support from the gastro centers. We don't need to initially target the primary care, which is a huge undertaking. So I think percentage-wise, we could probably, as Carl alluded to, grow faster in that sense.

Great. Okay. So we have a couple more questions. The first one I'm going to pose to you guys has to do with the difference or differentiate between being an R&D company and being a commercial company? And what steps did we go through to go from A to...

B.

B.

Yes. Well, first of all, it's not black and white. It was, as Laura alluded to, we were thinking commercially from the beginning. We knew that we had to build the world's largest and best Key Opinion Leader network, and that takes time, and we spent at least 5 years doing that now. And that -- without that, you won't get national guideline inclusion or you won't get any support when it comes to reimbursement where they are advisers or you won't get support when it comes to convincing other clinicians. So that's something we work for 5 years. However, there is, of course, a significant difference now. We are investing in a sales force. We have been investing in market activities, making awareness, but that has to be stepped up, and that's why we did this capital raise for several reasons. I mean if you want to employ, for example, very qualified salespeople, they want to see that the company they go to from well-paid jobs in other companies to a company that has the financial means to implement the great plans they show. That was very important, timing-wise for us. And of course, once you start selling, the investor community will be very interested in revenue development, of course, which is not a question when you develop, then it's more a milestone-based on results from studies and things like that. So there is a transformation in how we are going to be viewed as a company. There's a transformation investment for us. Now moving to the commercial side, the sales organization. R&D is built up. Yes, we will continue to invest there, but the majority will be in the commercial side. So there are many differences, and that's why we bring on real experienced people on the commercial side, like Mike, and we have Laura for a long time and so forth. So on the commercial side, we really are investing both in people and in systems like the CRM system, customer relationship management system that Mike is alluding to as well.

Great. Thank you. So our next question has a little bit of a lead up. Currently, screening is recommended for patients in high-risk groups with most vendors using MRI screening with a 97% specificity and 84% sensitivity. Could you give some more color if more patients in these high-risk groups are screened today in the U.S. and what the value proposition would be using IMMray's tests compared to the MRI when you start selling?

Well, one very easy thing to -- in that situation is that an IMMray in average cost of payers, the insurance company is $2,400, plus the cost of interpreting the picture, which just means, it's totally about $4,000 per imaging only with IMMray, and then they may also need endoscopic ultrasound or others. So it's a huge cost per tests they do with the imaging side compared to the $600 we are looking at for the blood-based test. Secondly, you have a bottleneck. I mean you don't have that many radiologists that are skilled enough to do this. You don't have equipment enough. We can't invest in absurd amounts of MRI and so forth as a hospital, whereas the blood-based test is a standard blood draw. So to scale it, today, the people who are in the screening programs for -- they are a minority, a small minority actually are the people who should get screen because there's not really a possibility to scale it up. So it's not -- as I said before, it's not a competition with imaging at all. It's simply making it possible to scale it up at an affordable cost for health care.

Mats, also, I think that, that estimate of the sensitivity and specificity of MRI is very high. I mean certainly, not applicable to low stage disease where patients may be receptible.

Very true. I forgot about that, Tom. That's absolutely true.

Well, a follow-up to that is, do you think some patients will offer an MRI if it's covered by reimbursement, if IMMray is paid out of their pocket?

I think they will have very hard times to get an MRI at all given the -- if that would be true, then there will be many more people in the current screening programs, which it isn't.

Great. Okay. So I wanted to ask a couple of questions that come in regarding our pipeline projects. So we talked a little bit about lung cancer already. But can you give an update on what's going on with RA? And you've been talked about that recently.

Yes. We had worked hard to -- and we have now a buy-bank of interest in-house. We also had to spend a lot of time getting the clinical data, which you need really to do a proper study. Right now, however, we cannot prioritize to do that work in the short term here because we're really, really are focusing to get the pancreas cancer to market. So it will come, but we won't give any exact time lines on this one right now. But we have the samples and the clinical information at hand, and we will run it as soon as we can prioritize people on this one. If we have the world's first and best test for pancreas cancer, a huge market in place, we have a verification validation study to complete to be first on the market for this incredible opportunity, and that's a very easy prioritization at the moment. So we have -- that's what we're doing.

Great. So a quick question about the validation process. Do we have our samples in the house?

Yes, absolutely. We have the samples needed for the U.S. one, and we are collecting some of the controls with the houses that have opened up. So it's looking really good, and we don't foresee that, that's going to be a problem.

Okay. So here's a question. I actually -- I'm not exactly sure I understand it, but I'm going to try to rephrase it. So I can make a little more sense of it. There are some voices that say we have not used enough data when we trained and validated data sets, especially when we're working with correlations and not casualty. And that we said that not validated with independent cohort samples that you always have used trained data sets.

No, no. Okay. I understand what you mean. I mean in general, you cannot train the algorithms and then test them on the same samples, then you do overfitting and you will get results that are much lower relevance for the real situation. We never do that in any study whatsoever, not even the earlier studies. So if somebody believes that is absolutely incorrect. We have always training sets and test sets separated, and they are not at all ever being mixed up in any sort of way.

And a follow-up to that is, is there any risk for using lock signature?

If there's a risk for using lock signature?

Yes, for the lock signature. Is there any risk for the lock signature?

Well, I'm not sure I understand the question, but you have to, of course, lock the signature and the algorithm for the product, which we have done. That's why -- otherwise, you can't run a verification and validation study in go-to-market. Or is the question...

But they're using individual -- independent cohorts for the...

Absolutely. Yes, yes, oh, okay.

Lock signature is not the same that we are now getting the news.

Absolutely. That's why we are getting new samples for the verification/validation, completely independent samples, of course. So in that sense, there's absolutely no risk for overfit or anything like that.

So we have a question. There's a lot of talk about the risk of us being taken over because of our share price. What do you think about that?

I think we have a fantastic platform. We have a fantastic product. We are first to market. There's no interest from us, and I hope not for the major owners I talk to, to be acquired or at the moment. That is -- it's -- we are in the stock market, so it's an ownership question as a CEO. I can only deliver, of course, to the best of the strategy. But given experience from working in large companies historically and looking and sitting on the other side, there is -- before you have started sales and proving yourself on the market, there is less risk now to get taken over. Now we are moving into commercial setting. That should raise the value, I believe, if you -- all your investors listening or buying shares that would help, of course. But there is no plan or thing to set up the company for an exit, not at all. On the contrary, we are very keen on developing the company much further than this, and particularly into the commercial setting.

And being successful.

Absolutely. Success is actually the best defense, if you want, because that will increase the value of the company.

Great. Well, I just wanted to make a quick announcement. We have 2 more questions. And after that, the queue is empty. So if there is anyone out there that would like to ask a question, please join the queue now. So one more question on the pipeline. Now that we have money in the bank and have a solid platform, how many more pipeline projects will we begin and when?

We will announce new pipeline products when we have data and decisions taken on that, and that will be done through press releases. We have -- the question is valid, of course. We have a great platform. We have lots of opportunities. But remember, I can't emphasize enough. We have a fantastic opportunity in pancreas cancer with the current product. There are maybe even further extended products in that area as well going forward, very, very interesting, of course. And we will spend a lot of the resources, making sure that we get commercial success. Investment in development is tough and long and hard in this area, but you need to spend equal amounts of resources in terms of money and people to get it through in the market or even more maybe. So key focus getting to become a dominant player in pancreas cancer. That said, of course, doing early studies, the only bottleneck is to define the clinical question and data together with Key Opinion Leaders, you have the cancer example and then get access to samples that in detail represent the situation you're trying to solve and then start the process as we've done in lung cancer and rheumatoid arthritis with a number of iterative studies until you have enough data and results and knowledge to go into a much more expensive process. So we'll release. When we start things, we'll tell you, don't worry.

Okay. So another question has come in. Operational stability is always hard. [ Thanos ] is obviously an extreme example of a company struggling with this. Could you please elaborate on the platform, the testing of instability, the quality assurance and so on?

Yes. There are so many levels of that and that -- I mean just saw in production here, when we produce the slides, you have built in QC for each the size of the drops being put down. You have a huge number of -- in between steps in the development process that qualify the stability, the variance -- technical variance, the handling variance and so forth. So we have enormous data on this. And we have run studies actually in the -- even in the lung cancer study, we did run several times with different operators to show, and they showed excellent with the results between different runs with different operators on the same samples on different days and also with different batches. And that was done many times during the development of pancreas cancer as well. These are things we don't -- I mean press release, we'll talk about because it's a natural part of building a platform and validating it and showing stability and so forth. But we've done extreme amount of work building on their work already done in the academic side. So there is a very strong position on that side.

I would say as well in the clinical laboratory, we have an extensive quality management system for delivering patient results. So not only at the production and manufacturing process, then delivery -- clinical test, we have a very strong QM system.

Yes. And one part of the development is -- has been to develop quality control tests that are now used in the clinical laboratories moving forward as well of various steps in the process.

Great. We have a whole lot of questions coming in on it.

That's great.

A quick question. Is the results from the development study in RA still scheduled for Q3?

We will not talk about the data because we are prioritizing the pancreas cancer. So we'll come back to that as soon as we see where we can fit it in given the workload now for pancreas.

Great. In the future, do you foresee any other types of pancreatic cancer project -- products, sorry?

Yes. There are other unmet needs in pancreas cancer than this as well. This is probably the biggest one we're going forward, but there are other big needs as well. One being monitoring of patients that have had surgery for recurrence. We don't know if we have a shot there, but what we may take a look at it, who knows. There's also -- you want to go earlier and earlier and earlier, they are pre, pre-cancer lesions, cysts and so forth that also possess a problem for the clinicians. So there are other areas in pancreas cancer to address as well going forward. And once you build up a Key Opinion Leader network and when you have a sales force focused on this, it makes sense to see if you can fulfill other unmet needs in the same area because it's very efficient in that sense. Then, of course, that doesn't say it may function. But of course, it's a...

It's a natural development.

Natural development to look up on these additional ones in collaboration with the Key Opinion Leaders, of course. We have a very clear picture of what's needed in the area.

Okay. So the next question is about the time line for our development project compared to our pancreas cancer project. Do you think it will be shorter, about the same? If shorter, why? Can you explain if it's different?

Okay. Yes. If you count the whole story from -- when we started with the early discovery studies in academia and all the way to here, it certainly will be shorter for many, many reasons. One is that we have built up the processes in R&D, all the tools. The production is super-efficient and much more reproducible for the very complex discovery where we have hundreds and hundreds and other antibodies on them. So the whole infrastructure is much more efficient. One thing that is always a bottleneck, and that is to get access to the high-quality samples and high-quality clinical data from the world's top leading centers in this situation. That's often a time-limiting steps in the discovery phases and so forth. But compared to building a whole company from scratch of 3 people when we started as building up everything production, all the quality processes, all the R&D processes, the clinical labs, the sales organization in parallel to developing product, definitely, a second round on a different clinical will be much, much shorter in total and much more labor-intensive. Going into nothing there, we look higher sales and marketing, that's fine. But the whole development and that process, we can reuse so much of what we built up here.

Great. So here's a question about the future...

The future?

After launching in the U.S. and EU, where will we go next?

Well, if you look on the world map, there is a small continent call Asia, for example. And of course, we are not focusing entirely. I want to thank you, [ Karen ] on your agents' success for the U.S. and then in Europe, as Laura said in 2 ways. But you all know -- well, many of you know that the incidence percentage of people who get pancreas cancer in relation to the population is, for example, in Japan, twice -- more than twice as high as compared to U.S. and Europe. And that's the same as we get signals from Korea and Taiwan. And if it's -- that in Taiwan, it's likely to be in China as well, a bigger problem, although statistics is not that reliable. So the interest for pancreatic cancer solution in Asia is very big. There's a different story how to get in the different countries. But after being very successful in the U.S. and now -- and in Europe, it's a natural step to see how and if we would go for the other part of the world as well. So it's a natural step going forward.

Great. So here's the question, sort of leading on that, would we pick up any kind of sales collaborations in the U.S. with diagnostic comps and so on that are already set up in the U.S. for some time?

All right. Our strategy now, as you said, of our own sales force and moving forward there, yes. When you look upon other potential products or situations where we -- there may be players where already have an excellent sales force like for rheumatoid arthritis or something, that could be a good target for a collaboration or a partnership or so forth. But the strategy right now is to focus on putting nice organization in place and then move forward there.

As the company grows and sales grows and the geographic locations grow, will we be adding additional labs?

That is very likely, very likely, especially in Europe. Initially, yes, we can deliver from Lund here, but the larger countries in Europe will require for market penetration to be very efficient that we have either partner labs in other companies that have a lab that want to do the test for us and transfer technology or...

We'll partner.

We'll partner with them. Or in some locations, makes sense -- it may make sense to set up our own laboratory in 1 or the 2 or 3 of the major countries, the big 5. Yes.

It's actually part of our commercial strategy.

Yes, exactly. Yes, it is. That's -- otherwise, you will not succeed in Europe, which actually many U.S. diagnosed comments discovered too late. But you have to treat country-by-country in a smart way.

There's a question, are there any specific types of cancers that are best suited for our IMMray technology platforms?

Carl?

Yes.

I think that's something for you. May we have you here?

Yes, I mean, what we measure is the combined results of what the immune response is against the tumor and what the tumor actually [ cessates ] into the bloodstream. So from that point of view there, we can measure pretty much everything. If they are very, very much encapsulated, we still measure the immune response against the tumor. But that's not really the question that we look upon. We look upon the clinical unmet need. And in many cases, we wouldn't go after tumors that, for example, have an overall survival -- 5-year overall survival, which is 90%, 95%. So we'd like to take the ones that are difficult to diagnose, the -- that has a lot of diffuse symptoms rather than going just because we can measure pretty everything. We've done 20 clinical trials with different tumors. And so what we go for are the most difficult ones. And they are still very much -- from a market point of view, they are huge. I can mention a number of them, but we can take that later maybe.

Okay. Tom, I think this is a question for you is the CLIA/CAP accreditation requirement to be able to sell the test?

CLIA is required to be able to perform the test for patients and to sell the test. CAP accreditation is not. But as I mentioned, I think it's a very important step for us to take because it's a real quality seal on our laboratory. That's going to be very important for selling to gastroenterologists and pancreatic specialists.

So that's why we now start selling directly as soon as the CLIA is in place. And then as Tom presented as well, we'll add the CAP, which is like a quality stamp, which helps the further penetration.

Great. Two questions on, I think, pipeline projects again. One is, are we working on prostate cancer?

As I said, we have announced that we're working on lung cancer and rheumatoid arthritis, and that's what we're working on. If we would start working on another one in the company, we will press release that at the right time when we have the right results.

Great. So in building the KOL networks for the pipeline projects, will it be influenced by the success of our IMMray PanCan-d?

Yes, it's true. When we started to build it many years ago in the pancreas cancer, 5 years ago, we were completely unknown. And we had only results from academia to rely on which are impressive. And Carl is well-known globally, which helped a lot. But the first ones to get them on board are the most difficult ones. Now on the pancreas cancer is more of a -- it's big people banging on the door wants to work with us, which is nice in various countries. So that's great. But it takes an effort in the beginning before you have the results in the particular cancer that you're going for. So that's -- therefore, anything that's close to gastro or pancreas cancer, as we talk is easier because it's on the same group or same departments, and they know each other or where they work. So as we are successful with pancreas cancer, that gives us strong credibility in areas that are close to pancreas in the gastro, particularly. So that's easier than going for something that is further away in principle. Nothing is impossible, but the first ones take more time than when you have -- the more data you have, the easier it feels.

Great. So our last couple of questions about reimbursement -- the reimbursement process. So this question says, we often see CMS reimbursement decisions as a driver for private sector reimbursement. Will this also be the case for IMMray PanCan-d?

Yes. It's important. One come before the other, but CMS is a key one since they cover currently some 60% of the U.S. population through Medicare and Medicaid. So you can't bypass it. If we get a private before, fine, but CMS is a key driver. That is absolutely true.

And a follow-up to that is, what are the steps and time lines of getting CMS reimbursement?

That's like -- Laura went through. We have had interaction since actually many years and so forth. We are now going to the interim analysis of the prospective studies, which is very important data to discuss and provide to the interaction with the payer organizations. They also give guidance, of course, on how the study should look like.

And they also give us guidance around the economy and data.

Exactly. I want to add to that because we have developed our health economy, they are going to do their own, but that's a perfect thing. If you don't have it yourself, you don't get a good discussion in that area. So health economy models, interim data...

Or the performance...

Or the performance, yes. And then, of course, the final readouts of the prospective studies.

Great. So the last question here...

I want to add also that is a different process. It's not only U.S. We have some other countries as well. So we work with authorities in the main areas where we are focused in Europe as well already with advisers specialized on each country that where we are

Prioritized geographies.

Prioritized geographies, yes.

Right. So the last question is, can you share with us what your policy contacts are telling you on current reimbursement trends versus the data you're showing now?

Well, when it comes to pancreas cancer, since there is nothing that functions, the guidelines say that shouldn't be screening for basically for -- sorry, imaging for screening widely because it doesn't pay off, obviously, given the cost and so forth. That's why the guidelines talk against it. If you have a blood-based test that is cost-efficient and with a very good negative predictive value, meaning high specificity, which we will have, then you have a much, much better situation to get a positive screening situation. However, note that of the 3 risk groups or risk situations that we are targeting only the familiar predictor is the screening situation. Screening means that you are testing people who have no symptoms, all right, regularly to find it. The early symptoms are people who have symptoms that may be pancreas cancer, but more often is something else. That's a differential diagnosis. It's a huge and large patient stream, but it's one test a person, not a screening situation, therefore, easier to get reimbursement. The nuance at diabetics, that's a surveillance monitoring in the sense that they have a diagnosis of diabetes. And then you don't need to test them more maximum for years, probably 2 or 3 years because data in large studies show that pancreas cancer diagnosis comes within 3 years. And the median is like 1 year approximately, 1. So it's not a screening. It's only the smallest group, and they are the most prone for self-pay, by the way. They have it -- they're familiar on that as a screening decision. Important thing because it's much harder to get any decision than it is to be a reimbursement for a diagnostic situation.

Well, and with that, we conclude the Q&A section of today's event.

Thank you. Great interaction. We like the questions. That's fantastic. And Laura, just something about the Immunovia virtual walk. It is something that you can engage in all of you who are listening.

Yes, yes. So like I said, we are in the process of finalizing our virtual walk. And we would very much like to see you participating and working together with us with our context that we had from the physical walks in the last 2 years with our personnel, with the clinicians, we will definitely -- and you have to help us to reach 40,075 kilometers, which is not that much actually, if you are also going to join us. And if you are interested, please send us an e-mail at virtualwalk.immunovia.com. The registration will open 19th of July because, as I said, this will end up on 19th of November, the World Pancreatic Cancer Day. And we would like to know if you are interested. So you will then be receiving the Immunovia bandana. So use it when you are going to go for the walk or for any activity that you can register on to our site. So looking forward to you joining us in our walk.

Great. And a final reminder, Immunovia's mission is to dominate the pancreas cancer diagnostic market. We are first of $4 billion U.S. market. We will launch in Q4. We are well financed for the finance we brought in, and we really needed that one to attract the right people moving forward. Now we have it. We are going full steam ahead. And we target a long-term 30% market share, which is exciting. Thanks a lot for listening.

Thank you.

We look forward to seeing you in person next year.

Absolutely. Go for it.

Thank you.

Thank you.

Bye.