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

Yes. I mean what I see in the community would be primary care physicians ordering maybe just a CT scan just to check things. But typically, what I do recommend is MRI or endoscopic ultrasound, either alternating or doing just annual surveillance. Typically, what we do is MRI to start. And then if there's anything concerning, we go to EUS If the patient has a really high risk, so they have multiple first-degree relatives or specific germline mutations, then we will do, every 6-month, imaging alternating with the EUS.

And how do patients respond to that kind of program, whether it's some combination of MRI and endoscopic ultrasound?

I mean, I think it depends on how anxious the patients are. Some of them are really anxious, and they want to do that every 6-month surveillance, which I'm completely happy to do. Some of them are just like, well, I kind of just want to do every year surveillance and go from there. So I really tailor it to the patient. There are no standard guidelines for pancreas cancer screening. And we have seen, and I have seen personally, just a big shift for insurances covering pancreas screening. I used to do peer-to-peers all the time just to get an MRI approved. And now, most of the major insurances are approving now high-risk surveillance for pancreas cancer. So that's been actually reassuring for patients that this is actually being covered for them. And so again, tailored to how anxious they are, and we've actually incorporated the IMMray into a lot of those patients as well. They can do that at that 6-month mark, just to give them that ease of mind that they're not waiting a whole year for that next surveillance.

Yes, that makes sense. And just to clarify Dr. Meguid's comment about the insurance companies providing coverage for pancreatic cancer surveillance. Generally, that is for those imaging approaches that she and Dr. Ligresti have talked about. So whether it's MRI or endoscopic ultrasound. As we've shared previously in different investor communications, we're still in the process of securing that insurance coverage for the IMMray PanCan-d test. And so that will be, as we mentioned earlier, kind of a key focus for us in 2023 as well as beyond that. We talked a little bit about how patients respond to the approach of imaging. Dr. Ligresti, what's been the response that you've seen from patients who you've talked to about the IMMray PanCan-d blood test.

Again, for a patient, right, as what they're looking for, right? They're looking for some peace of mind, some reassurance when they come see me. And what the testing conventionally has been cumbersome at best. For anyone that has ever had an MRI, it's claustrophobic, it's time consuming. It's expensive. It's a little scary. I've had my own set of MRIs and being down the tube for 40 minutes and holding your breath of 20 minutes. It's a little bit onerous. And to have to recommend that as a test every year for patients indefinitely until they get tired of it is an issue. And the same kind of view can be applied for endoscopic ultrasonography, what I do every day, right? So that's -- it's an endoscopic test. It requires sedation. It requires someone to drive you home. It requires half a day off. You have to starve overnight. So there's a lot of things where conventional testing falls short. So what the response has been from patients when I say, well, you know there's also a blood test potentially. And then they sit back and say, that's it. That's all you need to do, just a blood test. And the bottom line is, yes. If we get to a point where there will be more widespread adoption of just blood testing, for example, well then you've made patients' lives a lot better. Patients who are in surveillance programs, they worry about 2 things, right? Most of them are fairly convinced they're probably going to get pancreatic cancer at some point in their lives. And about 50% of that group worries about it on a regular basis. There's a smaller sub-percentage of that group that doesn't worry at all. And that's still the rare patient that I never see. The vast majority of people who come in to see me every Wednesday morning are extremely worried. They've heard stories. Grandma and dad died of pancreatic cancer at the age of 50, and they're convinced they're going to get pancreatic cancer. And those are the patients that a test like this can bring peace of mind to in a relatively easy fashion. Again, if I had a very expensive, difficult-to-do screening test, no one would show up.

Sure. That makes sense. And Dr. Meguid, how about you? What's been the response that you've seen among your high-risk individuals?

Yes, it's same. I mean, it's really just ease of mind. The process of actually ordering the IMMray test is so easy. And they get a phone call, the customer service is great. They set up the blood draw and then we get the results fairly quickly. And so I think it really does give the patients a peace of mind that they can do this blood test. If it comes back negative, that they can sleep for the next couple of months before their next surveillance screening. But yes, it's been fairly positive, I would say, the majority of time.

Yes. And can you talk about how you're incorporating IMMray PanCan-d test into your protocol? How are you using it? And how does that relate to some of what you talked about earlier with the imaging approaches?

Yes. So I started using it for the patients who are -- who I think qualify for just annual surveillance. I started using it at that 6-month mark. Again, the ease of ordering the test is very easy. And we can actually -- you can put a future order in. So that actually makes it really convenient. And so the annual surveillance getting at that 6-month mark. And then patients who have very high risk, so 2 or more first-degree relatives plus a germline mutation, getting it somewhere in between their 6-month surveillance, so either with the MRI or with the EUS. And again, just another peace of mind that they're doing everything that they can to catch this early.

Yes, that makes sense. And as you think about incorporating that with the imaging, is the idea of shortening those intervals to try to avoid the risk of a cancer that would develop in between the annual imaging screening?

Yes. Yes, exactly. So I would say if we do that 6-month interval and it comes back as high or border line, then I would say we would obviously do our due diligence and reinvestigate with more imaging or endoscopic ultrasound. But our hope is that patients still have to wait that year for that surveillance.

Yes. Yes. Same question to you, Dr. Ligresti. How are you blending the IMMray PanCan-d test with the imaging that is obviously still a really important part of this picture?

I just want to hammer home that this is all kind of a field in evolution, right? So we don't really have any kind of very firm ideas as to what the time frames will look like. There is a very large surveillance protocol at Hopkins where Dr. Meguid is from called CAPS. And that kind of really showed us that maybe a 12-month surveillance interval might be too long. But we don't know. We don't know if a 6-month time frame gives patients any more accurate information. We don't really have that information. So I just wanted to start with that point, which is we're not really 100% sure, and the guidelines kind of reflect that, of what the best surveillance protocol will actually be. However, stepping back for a second, the only 2 published guidelines that are out there from the ASG and the AGA, 2 big organizations in gastroenterology, they've kind of been fairly firm that 12 months is appropriate. And the surveillance, when the way we surveil patients with MRI and/or MRI and endoscopic ultrasound, either alternating or together, is also something that's evolving. So having said that, where does a test like IMMray PanCan-d fit in? Again, I think for me, like I alluded to earlier, I think a gatekeeping function would be very, very helpful, right? So if you had this large population of patients -- and how do you kind of distill them down to the patients that need investigation? Well, that's where you start to have these tiers where theoretically you can have the vast majority of patients not being evaluated, just simply getting a negative test and being on their way for another 6 to 12 months. And then you kind of distill it down to a very small number of patients that needs more investigative work out. So I think where it fits in my own practice is -- again, last year was easy. I was part of the pioneer program that you guys had, which is that we did everything for everybody. We did endoscopic ultrasound and/or MRI depending on what their overall risk might be and IMMray and tried to see if everything was concorded. As a year has gone by now, we found that things, in fact, have matched very nicely as the validation data supported. And we probably can use just the blood test as the gatekeeper. And that's ultimately what I hope to do in this practice is use that as my go-to test. And if that test is negative, see you in a year. And if the test is positive or border line, certainly further work up is necessary. And again, even that is still a little bit unclear, what that work up was going to look like. We do know that MRI and endoscopic ultrasound can be improved. We know that, in fact, both of those tests are not 100%. This may be where artificial intelligence kind of helps us a lot, where all of a sudden, we are doing better testing. Because again, there are patients that have these tests and then 11 months later, have cancer. And that's a problem. And we know that now based on the Hopkins data, where, in fact, these tests may not be as good as we think they are. So there's a lot to do still, and we're kind of at the beginning of that.

Yes. No, I agree. And one of the things that's helpful, I think, about having the 2 different perspectives on how you are thinking about surveillance today and how you're sort of blending some of these different approaches -- we definitely see different clinicians taking different approaches, since we don't have those clear guidelines that would map things out. So I do think it's really helpful to get your perspective and to recognize that it is evolving. And we'll continue to be looking at doing research studies that try to help provide some additional guidance and clarity, particularly for those clinicians that don't have the level of experience that the 2 of you do and are going to need more guidance along the way. And that, I guess, sort of leads into the next question, which is, what are the main hurdles to instituting the IMMray PanCan-d test in clinical practice? And maybe Dr. Meguid, we can start with you.

I think the -- there's very little, I think, hurdles. But maybe the biggest one is not being covered by insurance. But I mean, IMMray has a fantastic financial program for patients where it can be very affordable for them. But for -- in Colorado, patients live 6 hours away, and it's hard for them to come up here and travel. So you've actually made it very easy for us to coordinate their lab draw at a local place for them. And so I would say probably the only hurdle is the financial aspect that hopefully, we can get this covered by insurance one day.

Yes. And Dr. Ligresti sort of a similar question. Hurdles that you see or additional data and validation that would lead you to think differently about the test and potentially see its use expand.

Yes. I kind of want to address a few things. I think the #1 thing is, again, the testing process, I think, is great. I think we've kind of said that it's easy to do. And again, we have a lot of support to do it. Coverage, obviously, is an issue, and we're working on that. Medicare is perpetually a thorn in my side, especially when you're ordering MRIs and they don't even recognize the diagnostic code of high-risk surveillance at all. So the commercial coverage, I think is a little bit better than Medicare, but needless to say, that's also a work in progress. But just stepping back for a second, I think the bigger hurdle is kind of awareness. That's where organizations like National Pancreas Foundation shine. Because despite the fact that you see, in the news, people with pancreatic cancer, right, Jerry Springer, people like that out in the news regularly, it just kind of comes and goes. And people kind of say, oh, that's interesting or whatever, but it's not a common cancer. But overall, we know in the world, there's an increasing incidence of pancreatic cancer. And probably by 2030, it will be the second most common cause of cancer -- incidence of pancreatic cancer. And probably by 2030, it will be the second most common cause of cancer -- at academic medical center. There are lots and lots of patients who are not being referred. And why are they not being referred? It's just not on any -- not forgetting about on patients' minds, it's not on physicians' minds. And despite the fact that I could have patients who are coming from a high-risk breast clinic, that's easy, right, patients who are BRCA 1 or 2 positive. What about, again, patients with family histories or patients with, for that matter, pancreatic regions even who their doctors are not following properly or giving them the appropriate risk assessment? So again, one of the hurdles, well, in building a surveillance program or screening program -- I think the program is easy to run once you get that information out to the community that this is something that actually is possible. Again, most of the time, when you talk to clinicians as a large whole, even in 2023, there's a very fatalistic approach. Patients -- the patients are very much akin with what the physicians are in mind that there's really nothing to stew for pancreatic cancer. We're waiting for symptoms to arise. And once symptoms arise, then we'll work it up. And by that time, it's usually game over. So yes, we have a lot to do to get the word out, and this is where we really kind of tap into a lot of these grassroots efforts that are out in the country like National Pancreas Foundation.

Yes. Yes. It's a great point. There was a study out of New York University that found that the people that were at high risk for pancreas cancer, only about 21% of those high-risk individuals who qualified for pancreatic cancer surveillance were enrolled in a program. And that was in New York City, where they have multiple very highly regarded high-risk cancer surveillance programs, and they're relatively easy to get to, right? It's not the situation that you've got in Colorado, where somebody has to drive 5 hours to get there. And so we definitely have our work cut out for us. And maybe that's a good opportunity to bring David back into the conversation [Audio Gap]

Thanks, Jeff. I think it's continued outreach and education. I think through our partnership and partnership with our medical centers throughout the country, there's an opportunity for additional webinars. There's one-on-one opportunities with our medical directors to reinforce what medical professionals on the P&L have stated about. So I think it's really expanding the plan that we have in place, meaning we're working with our medical centers and Immunovia staff, to really take it to scale. I think that coming out of COVID, I think there's also a great opportunity to have in-person geographical meetings to really [indiscernible] clinicians and educate the public. So I think it goes back to marketing 101 of how we support each other and work with our medical centers to take things to scale. Honestly, to put it simply, I think it's a no-brainer. It's just a question of devoting marketing resources to get the word out about your test and bringing it to fruition. But that's one of the great things. And I appreciate the adjustment from our medical professionals of the impact of NPF, but it's a great partnership, like I said earlier. But it's just a question of taking things to scale and communication strategies.

Yes. Agree. Dr. Meguid, anything you'd add on how we address this problem of too few people and surveillance.

Yes. No, I agree. I think patients are unaware that they actually would qualify. I have seen a number of patients who have pancreas cancer and the patient's sister also have pancreas cancer. And their kids are with them. And it's like, okay, now you have 2 first degree relatives. You should be under surveillance. And they just have no idea. And so we have actually incorporated having a genetic counselor in our cancer program. And so if those patients are getting tested, they have a mutation. And then that actually -- then their siblings, their children could qualify for screening. So we try to just advocate that as much as possible that -- at that time. But I think it's just making the community aware that there are many, many patients that should be screened, and they just don't know it.

Yes, that makes sense. Let me do this. Let me just take a few minutes and talk about some of the early indicators that we're seeing of the market adoption of IMMray PanCan-d. And as well, some of the things that we are doing and some of the things that we're focused on to try to address some of the challenges that our panelists have raised. David mentioned, there are about 180 National Pancreas Foundation accredited centers across the country. There are also some other surveillance centers that are not yet accredited. We're knocking on those doors and encouraging them to reach out to NPF to get that accreditation. But there are a number of these centers across the country. From a commercial standpoint, this has been where we have focused our initial efforts for a couple of reasons. One, because these are highly concentrated centers where they have access to a large number of high-risk individuals. But importantly, it's also where physicians are that are looked to in their communities, in their states, and in their regions for thought leadership, so people like Dr. Meguid, Dr. Ligresti. Before we go out and talk to other clinicians about a test like IMMray PanCan-d, it's important for those thought leaders to have experience with the test. And so as you think about our keys to success here, having a robust clinical program is really important. These are often people who are at academic centers. They're demanding of the data that they want to see before they're going to use a test. So continuing to build out our data package is really important. We want to make sure that we give physicians some experience using the test. And so at times, we've done that at no cost to the patient so that the clinician can get some experience. And this is really where our sales team plays a really important role. So we currently have 5 sales representatives in targeted regions across the country. You can see in the map of the U.S. here, we've tried to roughly outline where those 5 territories are. You can see that they usually span 2 or 3 states. Frankly, we're not covering every square mile of 2 or 3 states with each rep. But what it does enable us to do is to have a presence at those key high-risk surveillance programs in those targeted states. What we're focused on is really making sure that we've got our messaging correct that we are providing the right kinds of education for clinicians. And as we do that, and as we get insurance coverage, we'll be looking to expand the size of that sales team to really start to address the broader need to build awareness. Some early indicators of success here. You can see, on the right-hand side, some of the centers that have started using the IMMray PanCan-d test. We've got 34 centers that have used the test so far. Of those, a little over 20 have ordered 5 or more tests. Why is 5 or more important? Well, sometimes in a market like this, you'll have a clinician that orders a test once or they order a test twice maybe they had an individual that came in and requested that they ordered the test. Those one-off examples aren't really where we need to go. We need people that are thinking about how this can be a part of their practice on an ongoing basis, thinking about the role that the IMMray test plays relative to the imaging approaches that they're using today. And currently, those high-risk surveillance centers are really at the bulk of the testing volume that we do. Last year, they made up about 83% of our testing volume. We also talked previously, and I think all of our panelists mentioned, the fact that one of the things that we really need to do is expand the market for early detection. It's not enough to just talk to the practitioners at these high-risk surveillance centers. We're also going to be having to take the steps to expand the market. We talked earlier about the fact that only about 1 in 5 people who's eligible for pancreatic cancer screening is actually enrolled in a program. And we know that there is high consumer demand for a simple blood test. And so as we think about how do we tackle these markets, one of the things that we want to do, and I think Dr. Meguid mentioned this, is talking to genetic counselors. These are practitioners who are experts in genetics. They understand the risks that exist for a given individual based on certain germline mutations that they have. And they're often the ones who are directing patients to different parts of the health care system in order for them to get the right kind of care, recognizing that they've got a higher level of risk. And so it's a pretty targeted group for these genetic counselors but It's a really important 1 for us to be focused on. The next is the gastroenterologist. And within the gastroenterology community, there is a subset of gastroenterologists that tend to focus a lot more on pancreas disease. In the United States, you've got a lot of private practice gastroenterology clinics. And maybe there might be 8 gastroenterologists or 10 gastroenterologists in a typical clinic. Oftentimes, in a clinic like that, 1 or 2 of those clinicians tends to focus on diseases of the pancreas. And so that's a good initial place for us to focus because some patients are finding their way to those gastroenterologist. But the reality is, if we just market to physicians, we're going to miss an opportunity. Part of what we've got to do is go directly to consumers, speak directly to individuals who are at risk. I think both Dr. Ligresti and Dr. Meguid talked about the anxiety that people have when they’ve got a family member who died to pancreas cancer. We want to give them a productive outlet for that anxiety and hopefully give them an action step that they can take in getting an IMMray PanCan-d test that helps to reduce that anxiety and helps them feel like they're in control of whether they are going to get pancreas cancer. And then obviously, we've got David from The National Pancreas Foundation on today's call. I can't say enough about the kind of partnership that we have with David and his team. They have been incredibly gracious in introducing us to key people in this field. They've been incredibly gracious in giving us the opportunity to speak to the patients and those who come to their website for more information. And so we'll continue to build that relationship. We've also got additional relationships with other organizations that are focused on pancreatic cancer to really make sure that we're doing everything we can to get in front of consumers and talk to them about early detection, first and foremost, to make sure that they're aware of the opportunity and then as well the IMMray PanCan-d test. Some early indicators on our performance here. So if you look at the number of clinicians who have ordered the test, we have -- over 100, 124 clinicians have ordered the test. 83% of those clinicians practice outside of high-risk pancreatic surveillance centers. So you've got an interesting dynamic with our business currently. If you look at the volume of tests, the highest volume of tests is going to those pancreatic cancer surveillance programs. But there are a large number of clinicians who have just started ordering the test and they're the ones that are -- but there are a large number of clinicians who have just started ordering the test, and they're the ones that are practicing out in the community. Maybe they don't have easy access to a high-risk program, but they're still worried about their risk. And so those are people that may very well be good opportunities to get testing by their gastroenterologist even if they don't go to a high-risk surveillance program. And we've got here on the right just 1 example of that. Dr. Simoni at Advanced GI is out on the West Coast in California. And as we talked to him, he was able to recognize that there was a gap in his clinic. He's a gastroenterologist. He does a lot of screening for colon cancer. It's a core function of what he does as a gastroenterologist. But the reality is he was the first to say, I'm not really doing much for pancreas cancer. And so we were able to talk to him about the opportunity for early detection, talk to him about some of his patients that might be appropriate and how to identify those, and get him to start using the IMMray PanCan-d test. And he's now at the point where he's ordering it almost on a weekly basis for one of his patients when it's appropriate. So in terms of these early indicators, I just want to conclude those comments and then I'll hand it back over to the panel for any final comments. But we see a tremendous opportunity here. There are just under 2 million people that are at high risk for pancreas cancer. They need help. They need additional solutions. And we believe IMMray PanCan-d can be one of those solutions. We believe that because of the enthusiasm that we've seen through the market, both among high-risk individuals themselves as well as among clinicians. We're really starting to get momentum in these high-risk surveillance centers that we focused on initially. Now, as we start to shift some additional focus to reaching out into the community and getting to other clinicians, we're just starting the efforts there. But we've gotten a good reception, and we feel like there's a great opportunity there. It's not without its challenges. I think within the clinic, one of the things that we hear quite a bit is, hey, this is about change and change management. We've got to change processes in order to implement this. Simple things like how do you identify the right patients within the practice to be tested can really require some thinking and planning on the part of the staff and that clinician. And then also, staffing is a challenge. Coming out of COVID, we hear this quite a bit from different practices that they just don't have the staffing levels that they used to. And so we're trying to work with them to identify ways that we can help, also identify ways that IMMray PanCan-d can also alleviate some of the burdens by making the testing process really easy. In addition, certainly, we're very focused on reimbursement. We heard that as a challenge from some of our panelists earlier today. And we know that that is a factor that will accelerate adoption of the test once we are able to get broader reimbursement. So with that, I would love to just put it back to the panel for any closing thoughts. And maybe Dr. Ligresti, we will start with you. You're on mute, Dr. Ligresti.

There you go. So as I was saying on mute, thank you for leading this effort, Jeff and Immunovia as a company. I mean, you guys have shown that you can throw down the gauntlet in a very challenging disease space and actually get success. I felt we've outlined as a panel today, I think a lot of the challenges that we see. But more importantly, we also, I think, showed very clearly that there is optimism here in this field, in this space, where there really hasn't been a lot of optimism at the best. So despite the fact that we have more work to do, more evangelizing to do, we're getting the word out, more speakers bureau type things that we need to do to get the information out to both clinicians and patients. We also see that this is a possible thing that we could actually offer patients. And for that, I remain grateful certainly to be part of this.

Dr. Meguid?

Yes. I echo everything that Dr. Ligresti said. But I think there's a lot of importance in the pancreas high-risk screening population, and IMMray is an excellent example of how this can be incorporated not only in major academic centers, but in the community with primary care physicians, gastroenterologists. So really looking forward to see how this pans out and very happy to continue to participate.

Excellent. And David, we’ll give you the final word.

Thanks, Jeff. Just one word that stuck out in your closing comments was momentum. And I think that's a key word to the buzz and the excitement and the reach of Immunovia, what's going on throughout the country in the medical centers. So I think the word momentum is -- from the time I started working with your company 18 months ago, there’s a tremendous amount of momentum. The other comment in my closing comments would be reimbursement, as you touched on a couple of times. And not to put in a plug for The National Pancreas Foundation, but we have a congressional briefing on June 13 at Capitol Hill. And there is a tremendous amount of buzz and conversations about reimbursement regarding genetic test and an early detection. And we actually have senators and congress, men and women, reaching out to us how they can get more involved and more vocal regarding the reimbursement. So I think it positions Immunovia, Jeff and your team, in a really positive position going forward.

Yes. No, I appreciate it. And certainly, we're excited to be part of that effort and grateful to be part of it as well. So I just want to say thanks again to our panelists. They devoted time away from busy schedules that -- I know it's a painful thing to have a normal day. But then to put something like this in the middle of it really reflects their willingness to be part of the solution and to really help drive the success of things like the IMMray PanCan-d test. But more importantly, how do we drive more early detection? How do we make an impact for those with pancreas cancer? And so thank you to them, and thanks for everybody who joined us. I really appreciate it, and we look forward to talking with you again soon. Take care.