Rigel Pharmaceuticals, Inc. (RIGL) Earnings Call Transcript & Summary
January 14, 2021
Earnings Call Speaker Segments
Tessa Romero
analystWelcome everyone to the 39th Annual JPMorgan Virtual Health Care Conference. My name is Tess Romero. I'm one of the biotech analysts here at JPMorgan, and the next presenting company that I'm pleased to present is Rigel, and speaking on behalf of the company is CEO, Raul Rodriguez. And before I turn it over to Raul, I just want to remind everyone that for those on the webcast, if you do have a question, please use the "ask a question" feature in the portal and I would be happy to ask the question on your behalf. Raul, over to you.
Raul Rodriguez
executiveThank you, Tessa, and thank you again to our colleagues at JPMorgan for inviting us to present at their conference. An unusual year, for sure, but it's been a very good year for us, in terms of this conference, and very much appreciate that. So let me tell you a little bit about Rigel, what we've accomplished, what we look to accomplish in the coming year and beyond. First off, an important statement are forward-looking statements. Please read this. It's also available on our website at our investor page. So we have 4 key value drivers at Rigel. And in 2020, a difficult, challenging year, perhaps the most challenging we've had as an industry, we've continued to make good progress across all of these. And in turn, also some opportunities have emerged. I'll tell you about each of those. Our first priority is to continue to grow our lead product, TAVALISSE, in the treatment of chronic ITP. Here, we grew sales to $61.7 million in 2020, a 41% increase over 2019. That's a very good result given the backdrop of this pandemic. The challenge is in pulling out our organization from the field and doing this mainly on a virtual basis, particularly impressive, given that the TPO class, the class we compete with, are relatively down to flat this year. So on that background, this is a very impressive growth. I also have no doubt we would have even done better than this had we been out in the field, and we look forward to being out in the field later in 2021. This is driven by 2 things: the quality of the people that we have; and secondly, the quality of the product that we have. And we focused this past year on supporting the earlier line use of our product. I'll tell you a bit more about that in a minute. Outside of the U.S., very good progress in 2020. We received approvals in Europe and in Canada, and we had our partner, Grifols, launch our product in the U.K. and Germany in 2020 and more coming. This is a tremendous opportunity on a global basis, ITP is about a $2 billion market. $1.1 billion of that is in the U.S., $900 million outside the U.S., a very attractive and growing opportunity in this area. The companion indication to ITP is warm autoimmune hemolytic anemia. And here, we've made very good progress despite the challenges of this year in moving forward with our Phase III trial in AIHA. We have just 64 of the 90 patients enrolled. I'll give you a little more color in a minute. The goal here for us is to be the first product to be approved in more warm autoimmune hemolytic anemia, and we continue to be the first and most advanced product in clinical development with a built-in advantage of already being on the market. I'll tell you something about that in a second. In December, we were granted Fast Track designation for our FDA -- NDA application, which means we are going to shave 3 months off the review period for this opportunity. A tremendous opportunity, we think it's about $1 billion market in the U.S., and we aim to be the first to get to that and therefore capture a substantial share of that. A year ago at this conference, we did not have a COVID program and neither did anybody else. Now a year into it, we have a very comprehensive COVID program. Fostamatinib has tremendous support biologically preclinically for its use in treating COVID pneumonia and ARDS, published by numerous colleagues of ours at NIH, MIT, Harvard, University of Amsterdam, our own publications, supporting this usage. I'll tell you a bit more about it because it's very exciting. This year, NIH launched a Phase II study of 60 people in COVID -- hospitalized COVID patients with fostamatinib, and Imperial College in London, launched a 450 patient clinical study of fostamatinib in COVID pneumonia patients hospitalized COVID patients. In addition, we've now launched our own Phase III study, and I'll tell you a little bit about that. A tremendous opportunity. It's hard to put a dollar value on that simply because it could be just so large, given that it's the largest public health crisis to ever afflict us in our lifetimes, and we have the fortune of having a product that offers some unique potential in this area. And lastly, the pipeline of the company has continued to make very good progress. 2 programs in Phase I., our RIP1 program and our IRAK1/4 program, and I'm delighted to tell you a bit more about our plans for each of those in this presentation. Moving on to Slide 4. This is the approved indication for TAVALISSE in ITP. It's indicated for the treatment of chronic ITP in adult patients who have had an insufficient response to a previous treatment, fairly broad area. But generally, the first-line of therapy is typically a steroid. So we're indicated for the use after that first-line, typically a steroid. It's a tremendous market. It's a rare disease market. As I mentioned, a $2 billion market globally. In the U.S., about 81,000 patients suffer from chronic ITP. About half of those, a little more are watchful waiting. These are patients who maybe have a milder form of disease or more likely even have a temporary remission, because this is a waxing and waning disease, and therefore, patients who are just being watched eventually need something, steroids or beyond steroids. Likewise, patients on steroids usually need something else beyond steroids where our label allows that. So there are many decision points here, which is what these little green arrows point to, as patients switch from one product to another product, to provide TAVALISSE to those patients. As you see here, the 22,000 or so that are post steroid are arrayed this way in second, third and fourth and fifth line. That 75% is in the earlier lines. So that gets us to what our objective is, to move into these earlier lines. As we launched the product 2.5 years ago, it was primarily used in the more refractory lines, which is pretty typical when you launch a new product into a chronic condition. But our objective has always been to move it upstream because there's more patients, more opportunity there. And we're doing that by leveraging our mechanism, our early data analysis and our safety profile, all of which are very supportive of the earlier line use. In addition to this, we've also launched an additional study, our FORTE study, to allow us to study second-line patients specifically to help us provide greater guidance to the use of our product in these earlier lines of therapy. This year -- a year ago at ASH -- 13 months ago at ASH, we presented some data showing second-line use of our product, showing that 78% of patients in the second-line are -- have the positive response, getting patients all the way to 50,000 platelets. That's a very impressive result. And as you see here, we've aligned, in the Slide 6, arrayed various lines. Earlier line patients do better. That's very typical of chronic immune diseases. The earlier you get to a patient, the more you're able to help them. And our goal here is to provide TAVALISSE to these patients as early as possible. The results are better, as you see here. We published these results in this British Journal of Haematology this past year. And it's been a key feature of what we discussed with clinicians that we interacted virtually this year. In this publication, you'll also see that the durability that we were able to share is quite impressive as well. So what we're doing in 2021 is continuing to focus on this early line use as a key driver of utilization for our product as we move up into earlier lines providing the rationale why we should be considered and used preferentially in earlier lines of therapy, and it's been something that is quite useful. We've done market research on this second-line data. Unfortunately, awareness is still not where it needs to be. It's still low, given that we were not in the field this past year. However, when we do share this data with doctors, what we see is that it does influence their behavior in terms of prescribing. So it's a very important piece of information, and that opportunity still lies ahead of us. And we will continue to focus on this and especially after we're out in the field later this year. Let me turn to TAVALISSE outside the U.S. Our goal here has been to put in place partnerships in the major markets of ITP: Europe, Asia, Canada, Israel, and put partnerships in place with companies that are very well qualified to help us sell this product, provide this opportunity to ITP patients globally. Typically, these are companies that have infrastructure already in place and have the ability to overlay our product on that infrastructure. And we've concluded partnerships where we received attractive economics from these. And they're in charge of commercializing the product. And obviously, we coordinate with all our partners on a global basis. For Europe, which is the largest market outside of the U.S., maybe about $450 million, we have gained approval early last year, and our partner, Grifols, launched the product in Germany and the U.K., and in the upcoming months, they will launch it in all the other major countries in Europe. We're delighted to have them as partners and delighted with their success in making the product available to patients in Europe. In Asia and Japan, we put a partnership in place with a specialty company, Kissei. Kissei has now launched a Phase III trial in Japanese patients to gain approval in their markets. In Canada, towards the end of the year, we gained approval for TAVALISSE in Canada for the use in ITP, and the product launched in December. Our partner, Medison, will be in charge of driving this launch and making the product available to our neighbors in the north. And the Ministry of Health in Israel, we expect approval in the middle of the year, Q2, for TAVALISSE in chronic ITP as well. So good success across the globe in making TAVALISSE available to patients suffering from ITP. We're delighted by this. Moving on to warm autoimmune hemolytic anemia, Slide 8. We are positioned to capitalize on this opportunity. To remind you a bit about the size of the market here, it's about 45,000 adult warm autoimmune hemolytic anemia patients in the U.S. Here's how we think they are ready. About half or so are watchful waiting, another quarter or so are on steroids, and the remaining is what's in the post-steroid market, a lot like ITP. There's a lot of transitioning from one to the other from watchful waiting to steroids, from steroids to second-line therapy and all around again. So really the entire 45,000 is the market in the long term. What's different about ITP here is that there is nothing approved for these patients. So there is a significant unmet medical need for the treatment of warm autoimmune hemolytic anemia. When we thought about ITP and we thought about TAVALISSE in ITP, it was always with this follow-on indication because it's such great synergies between the 2. The same doctors who treat ITP treat autoimmune hemolytic anemia. And as -- today, as we inform, educate doctors on TAVALISSE, on SYK inhibition, its mechanism, on its dosing, its safety, all of that is relevant for this indication as well. And that knowledge-based, experience-based comfort with the use of TAVALISSE in ITP will transfer to this indication once we have an approval in this area. So we're very excited about that. We are the first mover here. We're the furthest along. We're the only company to have Phase II data in autoimmune hemolytic anemia, and we're the only company to be well into our Phase III program in this area. I'll tell you more about that in a second. Just a note on the bottom of this slide, the bottom right of this slide. We saw in Phase II, about 44%, 48% response rates with our product in warm autoimmune hemolytic anemia, and the metric there was getting hemoglobin greater than 10 and a delta of 2 from their baseline. With this data on Phase II, we then moved on to a Phase III trial, a 90-person Phase III trial for registration. We've discussed this trial with the FDA. We have their concurrence. The primary end point we were able to elucidate after some discussions with the FDA is this: same, getting hemoglobin up over 10, delta of 2 from baseline on 3 consecutive available business. The available visit showed some flexibility on the FDA's part, given the recognition that during these pandemic conditions, occasionally, patients may miss a visit, and we wanted to make sure we were able to address that. So we're very pleased with this primary end point. This is a very rigorous end point, a challenging end point for a patient who meet without the benefit of a therapy, and we're excited about having this as a regulatory end point. Lots of secondary end points will be perhaps more clinically relevant in the terms of the things that we discuss with doctors, because this is something that doctors generally wants us simply to get patients to over 10, delta of 2. That's really their objective. Other metrics as well are included in the secondary end points. Now we're currently at 64 patients as of this week, and the pandemic has certainly delayed for ourselves and everybody else looking at this area. Nonetheless, we're pleased that we have 90 sites opened. We opened 90 sites for this trial, and so in 22 countries. And in 2020, having that many sites in that many countries really served us well. And it served us well because it allowed us to be enrolling patients in some geography and almost every time. So as the pandemic hit different countries and different places differently, some early, some late, other countries who were not undergoing that at that time continue to screen and enroll patients. So we've never stopped screening and enrolling patients, even in the most difficult year for conducting clinical trials in our industry, and we continue to look forward to that. So we think later this year, we'll finish enrollment of this trial. And then after that, we'll have the data. And as we get better guidance, idea in terms of when that might be, we could be a little crisper in terms of that time frame. I'd like to move on to COVID-19, Slide 10, and tell you a little bit about this opportunity because it's very exciting. The potential of fostamatinib TAVALISSE, in COVID-19 pneumonia ARDS is really tremendous. There's a very sound scientific rationale and based on internal and external research for doing so. We've launched 3 clinical trials, 2 being sponsored by our government partners at NIH and Imperial College in London, and then our own Phase III trial for registration. One of the things that is unique about fostamatinib relative to many other compounds that are being studied is that we are commercially available today. That is, if we were to show a benefit quickly, it can be adapted -- adopted to the use in COVID-19 patients. Today, TAVALISSE is on the shelf of most hospitals, and if doctors wanted to use it, for example, in COVID-19, they're allowed to do so, and that patient can receive TAVALISSE that very day. That's a tremendous difference from investigational products that may take many months or years to go through the manufacturing, the manufacturing and scale, the distribution system as well. One of the most attractive features, there are 2, of TAVALISSE fostamatinib in this area with our colleagues at NIH, Imperial College is its commercial availability. The other, and I'll tell you more about this, was the strong scientific rationale that we think, they think as well that TAVALISSE fostamatinib could have important impact on the course of this deadly disease. We think there's an opportunity here that will survive, continue even beyond vaccines. Vaccines will be a tremendous help, and I hope they succeed. However, many patients may not avail themselves of vaccines, unfortunately. And also the virus may continue... [Audio Gap] despite the availability of vaccines. And there's opportunity for non-COVID pneumonia ARDS as well that would be validated by our efforts here in COVID. Let me tell you a little bit about the rationale for this. Let me set this up with this slide. You may have seen a version of this slide before. What's most deadly about COVID-19 infection is actually not the virus. Few people die of the virus. What they primarily succumb to is their immune system's overreaction as it tries to address that virus. Effectively, the immune response is -- is a hyperimmune response, which causes the immune system to begin attacking other important tissues, such as the lung and other organs as well, eventually having death. When most patients arrive at a hospital, their viral levels are actually quite low or nonexistent. The body has done away with it. And what they're coming to the hospital for is compromised respiratory, compromised lungs and respiratory distress syndrome as their immune system attacks that. Here's how fostamatinib may help in this. 2 different approaches. One, similar to other autoimmune diseases, where the virus is coated by antibodies and then those complexes are recognized by Fc receptors in a variety of cell types that signal through SYK kinase, the mechanism of TAVALISSE fostamatinib. And that causes a cytokine release and a cytokine storm. TAVALISSE should help by mediating -- diminishing that SYK signal, diminishing that cytokine release and that cytokine storm. Separately and in addition, fostamatinib, the virus complex binds to what are called C-lectin receptor, CLR, that also signal through SYK kinase in a variety of cell types as you see here, resulting in coagulopathy through a process called NETosis. Now NETosis is a key driver of lung destruction. Fostamatinib is known -- in the SYK inhibition, is helpful in addressing the NETosis in this area, which is effectively the neutrophils spilling their contents into the environment, causing what are effective -- what we call NETs. They look like little nets. They're microthrombi. They compromise the lung and its ability to do its function, that is transfer air -- oxygen from air to the blood. That NETosis is a key differentiating feature of fostamatinib. We are the only product in study that addresses NETosis that is approved and is in this stage and that is what one of the key drivers of interest in fostamatinib, ourselves and our colleagues at other places, including NIH. Here's a study conducted by NIH and published in December. Our colleagues there, what they did is a very interesting study. They took plasma through COVID-19 positive patients. They overlaid it on neutrophils, and they caused a NETosis. You see this marker here in fluorescence in green. After 6 hours, you see tremendous amount of NETosis. Then when you do the same, but with fostamatinib, you see that the NETosis drops substantially. And that's exactly what you want to achieve in a COVID patient. This is obviously an ex vivo result, but we want to exactly do the same thing as we study this product in the clinic. So a tremendous opportunity. I'll give -- in the interest of time, I'll go quickly through lots of other preclinical information. This is our data. We did this in 2019, looking at animal models, showing we are able to improve ARDS with fostamatinib and colleagues at Harvard and MIT in Amsterdam, also publishing, independent of ours, in the benefits of fostamatinib in acute lung injury in COVID patients and the benefits of fostamatinib in hyperinflammatory response in COVID patients. We -- NIH is well underway in conducting this clinical study. It's a blinded placebo-controlled study, 60 patients, fostamatinib versus placebo. They're looking at safety. They look at numerous efficacy measures, including a progression of disease along a scale. They're currently at 44 patients, and we look forward to having this data, we expect to have this data in April of this year. So very shortly. In addition to that, we are, on Slide 18, conducting our own Phase III study for approval. We're looking at 300 patients on fostamatinib versus placebo. And here, we're looking at, again, efficacy end points progression on this WHO scale as well as numerous other measures that are included [Audio Gap] We're interested in partnering because there's so much potential here that requires substantial investment that we cannot do by our own, but with a partnership, we can accomplish. So I'd like to -- we look forward to putting a collaboration in place and will do so shortly with this program, and I'll tell you a bit more [indiscernible] we announce such a thing. On our IRAK1/4 program, a very attractive molecule, also a key immune signaling pathway. Remember, we are focusing -- for ourselves here, the opportunity is in large indications as well as rare immune and HemOnc indications. And there's an interesting data that was shared recently by another company that showed that there might be very good potential here. So we're looking at it in HemOnc and rare conditions for ourselves. We have a molecule that's a bit differentiating from others. We have an IRAK1/4 rather than IRAK4, and we put out substantial amount of data earlier this year at EULAR, sharing the profile of this molecule. Financially, we continue to [ observe ] good growth even this year in our bottles for TAVALISSE. We ended up with a good cash position that will be supplemented by additional non-diluted financing shortly. And to conclude, here's what we look forward to in 2021: continue driving ITP sales in the U.S.; supporting our partner as they make it available to ITP patients outside the U.S.; continued enrollment in our AIHA study and completion of that; we continue to focus on being first to market; results from NIH in April on the first COVID study; enrollment of our own study; and application for an EUA that is supported by the data; concluding a partnership for our RIP inhibitor program codevelopment, copromotion agreement; and then exploration of our IRAK molecule in HemOnc and rare diseases. So with that, I'd like to thank you for your attention.
Tessa Romero
analystGreat. Well, thank you so much, Raul. I'd like to join Dean as well now to the Q&A session. So we have -- so great. I think this was a productive presentation. I thought maybe we would start the discussion in ITP. Perhaps -- I guess maybe can you comment on what the new patient start trends and maybe the refill rate trends as well that you saw in 4Q and kind of what the expectation is for how that might trend into 1Q? Maybe we'll start there.
Raul Rodriguez
executiveSure. So we'll give a bit more color on our financial quarterly call in a short while. But 2020 was a very challenging year for the entire industry, the ITP competitors included. As I mentioned, some of our competitors were relatively flat to down this year. Despite that, we continue to grow, and we continue to accrue new patients, and that's very reassuring. Lots of entry points, as I said in my presentation, for those new patient starts and we continue to add new patients. We're not going to be specific here about that. But in 2021, once we get out in the field, when things normalize a bit on this pandemic, patients, more patients will be out there looking for new treatments. And we'll have the ability to interact with clinicians with very -- pretty potent data on our product to help them think about our -- using our product at various lines of therapy. And so that will be a very good opportunity for us to see that, because we feel like 2020 creates a flattening of patients out there looking for new therapies. But once that's released, that there'll will be tremendous opportunity for us in 2021.
Tessa Romero
analystGreat. And then how high has persistency trended during COVID? I think it stayed pretty consistent throughout the pandemic. Is that right?
Raul Rodriguez
executiveYes, it has been. You mean the persistency rate?
Tessa Romero
analystYes. Yes. That, exactly.
Raul Rodriguez
executiveYes, it has been. Our persistency rate continues to improve on a regular basis. And it's driven by 2 things. One, doctors are just better at using TAVALISSE; and secondly, as we move into these earlier lines, the response rates are better. So their starting points are higher. So the persistency continues to improve as we move that way. We expect it to continue to improve into the future.
Tessa Romero
analystOkay. Great. And then I think as we're thinking about 1Q, how should we be thinking about the donut hole impact for the quarter? Is this kind of a traditional 1Q for Rigel? I mean I guess, any color you can provide on that point?
Raul Rodriguez
executiveSure. So we'll have a little more color at our financial call. But -- and so I'll speak generically. Q1 is always the most challenging quarter for everyone. We -- you have Medicare donut hole issues. You have insurance resets, and those create obstacles for patients having access. And generally, patients work through those in Q1 and then things -- that results in a very strong Q2 typically. So that's a very typical dynamic. I don't think this year will be vastly different than that. And it has -- last year, the year before was that way. So I expect Q1 to be probably the most challenging year for all of us in the industry without being specific. And -- but then we've come out of it very strongly. And that dynamic, I don't see why it would change this year.
Tessa Romero
analystGreat. And I think you guys have launched your [indiscernible] study. Just quickly, is that something -- should we expect updates from that study over the course of time? And is there a potential that we could see some data from that this year?
Raul Rodriguez
executiveSo 2021, our focus is the second-line data in that publication from the British Journal. Really, we were able to publish that last year and frankly -- and we used it. However, our ability to use it was so constrained by being virtual as opposed to being out in the field that the opportunity is still tremendous there because awareness is not -- is it really -- not where it needs to be. We're going to drive that up, but it requires us to be out in the field discussing it. Because the volume of interactions is substantially larger when you're out in the field rather than constrained by a Zoom meeting. Doctors are simply not willing to have that many Zoom meetings. I can understand why. And so that's tremendous opportunity in 2021. There's other publications coming to help make the argument for the use of our product preferentially as well. And the combination of those things will be very useful. And that really is the focus of '21. Our own study probably will help us more in 2022 because we have plenty to talk about and plenty of untapped potential as yet with the second-line data so far.
Tessa Romero
analystGreat. Great. And I think just switching now to warm autoimmune hemolytic anemia. You guys are continuing to enroll that study. I understand it's a global study so you have [indiscernible] sites that are enrolling patients. But do you have any kind of internal time lines on that or internal expectations on how quickly that could enroll? Could it be enrolled by the end of this year or sort of too hard to say?
Raul Rodriguez
executiveWell, I certainly hope it's enrolled by the end of the year. We are at 64 patients out of 90. So we need 26 more patients. Just to remind you, we opened up 90 sites around in the world, 22 countries to get that. So given the number of sites and given the number of countries that are involved in getting this done, we think we're well positioned to finish that enrollment this year. Most likely it will be somewhere in maybe summer, maybe Q3-ish orders of magnitude in terms of the time frame. I can't be that specific unfortunately, and it's simply because we don't know what the impact of this current wave of the pandemic will have on us. Certainly, it's having a suppressive effect in terms of enrollment, no doubt about it. The question is how quickly we come out of it and how quickly we accrue these remaining patients. It's only 26 patients remaining. We're 70-plus percent enrolled in this trial. So it's not that far out there in the future. So we're comfortable. We have the infrastructure in place to do it and that we will do this, this year. Without being more specific.
Tessa Romero
analystYes. That's great level. And then, I guess, you guys are kind of moving forward a bunch of different efforts in COVID-19. You've got 2 trials at investor [ leader ] sponsored trials and then the Rigel-led trial. I guess, maybe you could help frame expectations for the first, in particular, for the first data set that we're going to see, it sounds like in April from the NIH Phase II study. So maybe -- yes. In the interest of time, maybe initial expectations for that study?
Raul Rodriguez
executiveYes. So the underlying preclinical work for the use of fostamatinib for SYK inhibition in COVID pneumonia is tremendous. It's tremendous because it really shows that our product, being a very active potent immunomodulator, is potentially very helpful. And it's helpful in addition because we have no -- we do not interfere with the body's ability to fight off a virus. Because you want a product that doesn't interfere with that. You want that to happen. At the same time, you want to modulate the immune system down. You also would like to have a product that works in a couple of different ways, as I shared earlier, cytokine storm as well as the coagulative problem caused by the virus and addresses those issues. We do. Both NETosis as well as key drivers, other key drivers of potential. So the biology underlying it is really tremendous. And given that it's already on the market and available, that is, as our colleagues at NIH say, "It's shovel ready." If we show good data, it's available to be used soon to helping this terrible pandemic. That's a tremendous place to be. The trial being done by NIH is a 60-person study. It's a small study still, keep in mind. So primarily -- and safety is a first end point. The secondary end points are efficacy end points, and given the size of that study, we're certainly looking more for trends than anything. It's not powered to show definitive numbers. That's not a registrational study. So really to show efficacy trends would be very helpful. One of the unique things about this NIH study is that they have a tremendous translational effort underway, looking at key biomarkers, NETosis, in particular, but others as well. So we could show strong trends on efficacy correlative with strong biomarker work supporting that. That's a tremendous outcome for that study and sets us up well for pursuing discussions with FDA on EUA potentially.
Tessa Romero
analystYes. That's perfect. That was actually one of our e-mail questions. Is there -- is there a potential for an EUA to kind of emerge if the NIH data is positive. And it sounds like maybe potentially that's something that's under consideration.
Raul Rodriguez
executiveWe will approach the FDA and begin those discussions after we have that data. And I -- because I think that will be very helpful to have data to discuss with them. And that will create such a thing. So we'll initiate that after that data.
Tessa Romero
analystOkay. That makes a lot of sense. And I guess maybe a broader question, Raul. I guess the treatment algorithm in COVID-19 is constantly evolving. We have vaccines now. We have some therapeutics emerging. So I guess as we're thinking about actually the market potential of fostamatinib in COVID-19, how should we be thinking about that ultimate -- the TAM of the COVID-19 opportunity?
Raul Rodriguez
executiveI appreciate the confusion in COVID because there's so much information, it's overload, and so much information on so many different mechanisms. So let me try to simplify it. I use that little chart with the various waves on it to help out a little bit. There's some products that are antiviral, remdesivir, some of the monoclonal antibodies. Put those to the side. They try to suppress the virus. Vaccines, very differently, they try to create an immune reaction in the body to suppress the virus if you do get infected. We are focused with fostamatinib on the immunomodulator area that is patients that are hospitalized at present and that come in, and they're having an overactive immune system, destroying their lungs and other tissues. That's really where we're focusing on. It's in hospitalized patients, overactive immune system. And there in that class, you look at, what are you wanting in this type of immunomodulator? You want a molecule that suppressant cytokine release, check. You want a molecule that addresses NETosis, check. You want a molecule that does not impede the body's defense against viruses, check. You want a molecule ideally that's approved, ready to be used in this area, check. All of those things are things that fostamatinib brings to this. Other compounds very rarely do. There are many things in study, and that causes a lot of confusion. But if it's approved, and on the market, that should be one cut because if they're not, they're far away from being helpful. Does it do to the other things that I said? Available. The unavailable is it works in cytokine storm, helps the key drivers of that lung destruction, is an active immunomodulator and doesn't impede the body's ability to fight off the virus. Those are the things you want to have in a molecule, and we have those with fostamatinib. So we're excited about the opportunity there. The field is evolving constantly, and that's something that will continue to be the case. And I think the overlay of our product over in this segment, I think, is critical. It will be, for example, dexamethasone is used frequently. It's an easy drug to use. Most of our patients being studied are on dexamethasone, for example. Dexamethasone helps a little bit, but not -- frankly, not that much. So we're hoping to be able to provide a much more better result with fostamatinib that overlay dexamethasone, for example.
Tessa Romero
analystGreat. That's really helpful. Well, great. I wanted to thank everyone for a really helpful session. Thank you to the team. Raul, Dean, thank you so much for joining us and all the investors for listening today. We really appreciate it and I hope everyone has a great rest of the conference.
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