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

Hello, and welcome to the Immunovia third Quarter interim report. My name is Patrick, and I will be your coordinator of today's event. [Operator Instructions] I am now handing you over to your host, Julie Silber, Director of Investor Relations, to begin today's conference. Thank you.

Thank you, Patrick. Welcome to the call. Before we begin, I'd like to give a quick reminder to our listeners. Today's webinar and call, management may make forward-looking statements that involve known and unknown risks, uncertainties and other important factors beyond the company's control that could cause the company's actual results, performance or achievements to be materially different from the expected results, performance and achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this webinar speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. Now I will take you to the agenda. In today's call, we will go over third quarter 2020 highlights. We will talk about the remaining steps to launch, our road to market, the discovery studies, and we will summarize before we go to Q&A. And now with these formalities over, I'd like to turn the call over to our CEO, Patrik Dahlen. Patrik?

Thank you very much, Julie. It's truly an honor and a pleasure to be here today. It's obviously my first quarterly report reporting for the quarter 3 of 2020 for Immunovia. And a big thank you to all our employees who has made this quarter an exceptional quarter for Immunovia. I'd like to start off by moving into the helicopter for a while and take a look at sort of what is important to Immunovia right now. Obviously, it's really all about all hands on deck for securing a sales start in quarter 1 of 2021. So just a few months into the future. Why is this important? Well, first of all, we want to be first to market with a solution for early detection of pancreatic cancer. Pancreatic cancer is one of the hardest to detect and diagnose cancers. This means that whilst it's not the most frequent cancer, it is one of the most deadliest cancers in the world. In U.S., it's the third deadliest cancer to date. And the main reason for this being such a deadly cancer is the late detection, the late diagnosis of pancreatic cancer. So it becomes difficult to treat. This is why we, Immunovia, have a very, very important mission to be providing a future opportunity for the early detection of pancreatic cancer. This is also why we, in our assessment of the market, can see that there is a great market opportunity for us in the excess of USD 4 billion according to our own estimations of market size. As I said, we are planning to start sales of our PanCan-d assay in the first quarter of 2021. Currently, we are well funded. We are fully funded as a company for the commercial rollout. We have cash at hand, SEK 510 million. So we're well funded for the commercial rollout and beyond. So we are a company in a great, great shape. And as you all know, our commercial activities in the long run are aiming at achieving a 30% market share for IMMray in terms of early detection of pancreatic cancer. So we are very ambitious in our goals for the future. In terms of quarter 3, we have been very, very busy. It's been an exceptionally busy quarter for Immunovia. If I start by looking at organizational changes, obviously, in August, we announced that I would be stepping in as the new CEO, following Mats Grahn, who has been the CEO of Immunovia for almost 8 years. And on that note, Mats then was elected to move into the Board of Directors, which was verified by the extraordinary general assembly in September. In terms of marketing activities, we have presented at the European Pancreatic Club and the International Association of Pancreatology, which we did in July. And we have also launched the Immunovia Walk Around the World, and I'll come back to that at the very end of our discussion today. The main highlights for quarter 3 for Immunovia is clearly the results from the CTMS that were announced in the beginning of September in a webinar, and I'll come back in-depth and discuss about those results as well as the more recently announced results from our Verification study, which, again, I will present in more depth in the next slides to follow. If we start with the CTMS study, it was a large multicenter case controlled study, where we had patients enrolled both from the U.S. and Europe. In total, 1,113 serum samples, with 315 PDACs in Stage I through IV, 310 healthy controls. [Audio Gap] So in the beginning of September, we hosted a webinar, focusing on Commercial Test Model study or the CTMS study as we call it, which was a multicenter case control study with 8 U.S. and European sites participating. We had a large number of serum samples, 1,113 serum samples in all, 315 PDACs in Stages I through IV, 310 healthy controls and 488 symptomatic controls. We performed the study using our 8-plex biomarker signature with the addition of CA19-9 included as a part of the biomarkers that we use. We were able to arrive at really great results with an area under the curve of 0.94. And for PDACs versus all controls and for PDACs versus symptomatic controls, we had an area under the curve of 0.93. So very great performance and a good outcome of the study which then, of course, enabled us to move forward towards the next important study, which we just announced recently, i.e., the Verification study. In the Verification study, again, it was, again, the multicenter case control study, covering 519 patients with 81 PDACs in Stage I and II, 114 PDACs in Stage III and IV, 212 healthy persons and 112 symptomatic controls. The PDACs versus healthy controls came out an area under the curve of 0.94, and the PDACs versus all controls came out at area under the curve of 0.91. When we then analyze the data further, we looked at the specificity of the test and for differentiating early Stage I and II PDAC patients from healthy controls, we derived at the specificity of 99% and the sensitivity of 78% with a negative predictive value of 0.993. So clearly, giving us a very good indication that we have a very specific test and with a high sensitivity, enabling early detection of PDACs even as early as Stage I and II. The early Stage I and II PDACs were also differentiated from all controls at a good accuracy of 91%. There, the specificity was 93%, sensitivity of 78%, and the negative predictive value of 0.993 again. It's very important to say that this study was conducted with no samples using a verified software, locked production processes and locked QC methods, everything run in a locked version that was concluded from the CTMS study. So we're very pleased with the outcome of the Verification study, and this enables us to move forward to the next stage in our development towards the road of commercialization. And obviously, the next step is a Validation study where we repeat everything again, but this time with completely blinded samples. So that was quarter 3. And now I want to talk a little bit about the remaining steps to launch as the next discussion. We've obviously taken multiple steps towards commercialization. It is a long road, obviously, and we are nearing the end of it. We just completed the Verification study with a locked signature and algorithms and with known samples. We just reported that. And we are now in the Validation study process where we are collecting the last samples. We will be running the Validation study with locked signature and algorithms like we did for the Verification study, of course, and this time with blinded samples. And this now enables us according to the plans that we have, enables us to launch the test in the United States in quarter 1 of 2021. And then with subsequent testing starting and following in quarter 2 of 2021. So we're very, very pleased with where we're at. We think we have made great progress during the year and during the quarter, and we are very excited about the outlook for the quarter 1. With regards to the market, again, I just want to go back and reiterate that this early detection of pancreatic cancer is an extremely important health care measure. This is a very severe disorder. It's important that we detect the cancer early so that we can -- that the doctors can operate on it and that we can treat properly the cancer. As you all know, the survival rate is as low as 10%. Some countries even reported lower than that over a period of 5 years post-treatment or post detection. And therefore, it's important that we are able to provide an early detection so that patients can be better treated going forward. We have 3 patient groups that we address. One is the hereditary or familiar group of patients. There's about 200,000 patients in EU and U.S. And the idea would be to monitor those patients twice a year. And that in itself is a very interesting market group for us or a target group for us. The other risk group that we have is the symptomatics or those with early concerning symptoms. There's about 1 million new patients every year with concerning symptoms. And these patients, we are assuming our model would need one test per patient. And then the third risk group that we see is the new onset diabetics with an age of over 50 years. Of that category, there is circa 3 million or more new patients every year, and they would need a test per year in a couple of years, sometimes even more frequently. And this is also a growing group of patients that we see that are in the risk group or in the addressable group, so to speak. So this is a very large market, and it's a big health care concern that we are addressing going forward. The road to market then and how do we proceed from here. Obviously, the first wave of commercialization is in the United States. We have labs set up. We're going to conduct the Validation study and run that so that we can file for state approval, get the CLIA and start the testing in the United States in our lab in Marlborough in Massachusetts. This is also the most important market for us, clearly, and not only short-term but also long-term the U.S. remains to us a very important marketplace. The second wave of commercialization is in Europe. Obviously, our own home market, being Sweden and the Nordic countries, followed by the EU5, which is very important for us. We have a number of countries where we already have very close collaborations with key opinion leaders. And also, as you would imagine, from sites that provide us with prospective samples. These are obviously also areas where we will be focused in terms of our early commercialization here in Europe. But obviously, this will follow once we are commercially successful in the United States. The time lines. We have discussed, I think, many times before, but I'll just reiterate those. Obviously, when we look at the time to market, I'm sure there are investors and analysts out there thinking we've been going at this for quite a while. But it is a unique and very difficult task, of course, to provide an early detection for pancreatic cancer. And it takes a number of well-designed studies to get there. In the past to date, obviously, we focused a lot on the retrospective studies doing now then the optimization of the test, and we are now proceeding to the final portion of that, i.e. the first Verification, which we have performed. And now the final stage of that is obviously the Validation. In parallel with this, we have already started back in time prospective clinical studies. So collecting samples to be ready to analyze with the finalized test and the validated test and to provide clinical prospective evidence of the effectiveness of the test also going forward. This will be very important in the long run for us to provide data to the payers and the decision-makers and the key opinion leaders with regards to the evidence of the detection and sort of the discussion around reimbursement rates. Obviously, in the short run, especially in the United States, but there is a possibility to launch the test, and this is what we will be doing for self-pay sales. There's a large cohort of individuals who have [indiscernible], hereditary trait and there is an interest there. And of course, people in general, who are concerned about their health will be able to enroll in a self-pay approach. And then, of course, we will continue going forward confirmatory market expansion studies in different geographies, et cetera. We have and continued to be very focused on the United States and Europe. Personally, I think also the Asian markets with Japan and China, in particular, where we see very high incidence of pancreatic cancer, obviously, in the future will become even more important for us as we move forward. In terms of discovery studies that we have ongoing, just a couple of words on those before we move on. The discovery studies that we have are in early stages. And we're obviously active in 2 areas. One is in lung cancer where we aim for early diagnosis. We're doing sample collection at the moment to get a proper patient cohort to analyze, and we will be announcing data as we move forward. But again, it is early stage. And therefore, there is no firm time line with regards to announcements of new data in that field. For rheumatoid arthritis, the situation is almost the same, i.e., the early stage. It is discovery stage. We do have a biobank there. Unfortunately, it's a historical nature. And given our history with regards to historical samples, we cannot only rely on that. So we have started prospective collection also for early-stage discovery stage work there. Obviously, with rheumatoid arthritis is not for early diagnosis as it is for lung cancer. But there, it's more for accurate detection and being able to distinguish the different groups of rheumatoid arthritis that exist and that are hard to diagnose yet important to diagnose. Moving forward, in summary, I think Immunovia is in a very, very exciting part of its journey. We're just months away from starting sales in the U.S. We're moving very quickly forward towards that we have all hands on deck, completely focused on that task and that task alone, and we are committed to succeeding with that. With that, I'd like to open up for any questions that you may have.

[Operator Instructions] Our first question comes from the line of Viktor Sundberg from ABG Sundal Collier.

So my first question relate to the recently announced Verification study. So if you back out the specificity and sensitivity of IMMray and PDAC stage I and II patients compared to only symptomatic controls, at least I get a mid-80s number for specificity and the high 70s number for sensitivity. Do you think the test needs to perform better than that in order to screen or test the new onset diabetes population, for example, given that it's almost 1.5 million Americans get this diagnosis every year, so to speak. Would you feel confident with these numbers so to speak?

We do feel comfortable with the numbers. Obviously, given the better performance against healthy controls and unsymptomatic individuals, we would have hoped for a higher number. It's really all about sort of the prevalence of the disease and PDACs versus how many samples we call negative versus positive. So at this stage, we feel comfortable. But obviously, we still need to continue to work with the key opinion leaders and work with the clinicians to also get their view and their feedback in terms of how they see the sensitivity and the specificity in this particular group. And as we sometimes ago discussed in terms of the diabetics, there are subgroups also of the diabetics. And so it also is a little bit of a question of being able to possibly enrich the group of diabetics. Now I have been a full week and a few days here in Immunovia as the CEO. So it's a little bit early for me to maybe give a complete clinical response to your question. But basically, this is kind of our -- or my early thinking about where we're at.

Okay. Could you also perhaps add some flavor on the retinol for combining IMMray with CA19-9 as we've seen in the later studies there?

No. We think the IMMray and CA19-9 as a combined panel, really. So it is important to include both components. So they kind of work together and they enhance each other. So that is, I think, very clear to say that CA19-9 combined with IMMray is very important and cannot be kind of separately discussed, if I put it that way.

Okay. And will you also keep the market updated around when you have all the samples in the [indiscernible] there Validation study? And also to clarify, will the slice of the Validation study to be the same as the Verification study? Or will it be bigger to compensate for any discarded tests?

We have inclusion and exclusion criteria. So obviously, for our samples coming in. So we do the exclusion just based on that. So we don't discard samples during the study per se. So it's -- of course, no. So -- but we -- obviously, when we have the data from the Validation study, we will be announcing that and giving that data. We have discussed previously with the market that given the COVID-19 pandemic and the sort of uprising again of the COVID-19, we have seen a decline in collection of prospective samples. However, that said, the time lines that we now have set with regards to being able to complete the Validation study are still valid and they take into account the slightly slower or the much slower, I should say, collection rate that we see at the moment. But this has been taken into account, and we don't anticipate any delays in getting the samples ready for the Validation study.

Okay. And just a final question from my side before I jump back into the queue. This perspective into a readout is planned for the first half of next year. What in terms of data should we expect from that interim readout?