UroGen Pharma Ltd. (URGN) Earnings Call Transcript & Summary

Okay. We will continue with the next session. Hi, everyone. I'm Paul Choi, SMid Cap Biotechnology Analyst here at Goldman Sachs. And thank you for joining us for our 42nd Annual Global Healthcare Conference. Our next session will be with UroGen, and we're pleased to have CEO, Liz Barrett; and Jeff Bova, Head of Commercial, joining us here. What we'll do is turn it over to Liz for some opening comments and then go into Q&A. As with prior sessions, if investors have questions along the way, please feel free to submit them via the webcast portal. Alternatively, you can e-mail them to me, and I'll read them out loud time permitting. And with that, I'll turn it over to Liz.

Thanks, Paul, and thanks for having us. I asked Jeff to join because I know a lot of the interest is around what's happening with the commercial launch. It's an exciting time for UroGen. I always say that I say this every time. This is a pivotal year for us, but it is a pivotal year for us. We were laughing because we actually -- someone asked us, we talked about launching June 1. And someone said, "This year?" I was like, "No, last year." We launched our first new medicine, June 1, 2020, right in the middle of the pandemic. I know that Jeff had spent the last couple of years prior to that preparing for launch, only to have everything switch at the last minute. So I'm really pleased with the way things are going. It's an exciting time for us. We're coming out of the pandemic, and Jeff will talk a little bit about that in Q&A, how things are going and what we're seeing out there. But it's really an exciting time for us. We're able to bring this medicine to the market and to patients with a single-arm study because the FDA recognized the high unmet need in this area of low-grade upper tract urothelial cancer, where these patients -- 70% to 80% of these patients actually lose their kidney. And when you're talking about a patient population, they're 70s and, that's actually a really big deal. So there had been no medicines actually approved by the FDA for this disease, and so we're really pleased to be the first one to bring it. In addition to the commercial launch, which I talked about, 2021 is all about the commercial launch, we have a lot of other exciting things happening in our portfolio. We read out last year around our UGN-102, which is for low-grade non-muscle invasive bladder cancer, a portion of that patient called intermediate risk. Again, a patient population with a high unmet need because these patients end up getting repetitive TURBTs because the TURBTs doesn't work for them. And so we're really pleased again to be able to bring this new medicine forward. We're in our Phase III study right now, enrolling patients around the world. That's going well, the enrollment. We were actually really happy with May. We hit our enrollment numbers, which is a big deal, as you know, particularly, again, as we're coming out of the pandemic. So it's been a challenging time for us, but an exciting time. And we're pleased with the results and what we've been able to do to advance our portfolio. And then lastly, we have our immuno-oncology assets in early development, preclinical right now, working with our TLR7 agonist in combination with CTLA-4 local delivery with our proprietary RTGel. So again, a lot happening, keeping it going. We did some financing, as everyone knows, this year. So we're in a great financial position and just looking forward to continuing to advance not only the commercialization and bring this new medicine to patients, but also in our portfolio. So I think I'll just stop there and go to Q&A, and we can go from there.

Great. Thanks for that overview, Liz. Clearly, a lot going on with the company this year, but you did, of course, sort of referenced probably what is top of mind with investors, which is the launch. And like a lot of recently, commercial stage companies, you did highlight that you did launch last year into a COVID environment. So I guess, maybe to help us understand or maybe mark-to-market, can you -- you or Jeff alternatively, sort of provide an assessment of what the landscape is like and sort of what is like -- what our sort of the current trends or updated trends with respect to patients returning to offices and seeing their physicians and just kind of what are the nature of the conversations patients are having? Is this sort of more of a catch-up? Or are they at a point where they're already sort of actively talking about therapeutic intervention? So maybe just sort of an update on what's happening in the market with physicians.

Sure. I'll talk more broadly, and then I'll turn it over to Jeff to talk more specifically about uro-oncology. But the reason I talk more broadly about is you read kind of every day, first of all, when a lot of companies read out their Q1 and their 2021 -- I mean, the 2020 results, everyone talked about the reduction in new patients. And that was really unfortunate, particularly when you're talking about a cancer diagnosis, be it was down 40% in 2020. So as you talk about what's happening now, and I was just reading yesterday that things are starting to come back to normal. Everybody expects normal to be back in 2022, but we are seeing more patients comfortable coming in, not just again for us at UroGen, but overall in the industry, which is something we need to do. It's really unfortunate because a lot of these patients, what I'm hearing, just anecdotally and talking to physicians, they're saying when patients come in now, they're just further along in their disease. So it's like -- because patients were afraid to come in, so we have to make sure that patients understand it's safe now, with everything that's happening in the vaccines. Thank you, all the companies that developed the vaccines, and I think that's really important. But I think we're going to see it get back to normal, but I think it will still take some time. And you may see a bolus of patients, I think as you commented about it, but I don't think it's sort of like a huge bolus. I think patients are trickling in over the month and have been. So with that, I'll just turn it over to Jeff, and he can talk more specifically about what he's seeing specifically in our area, Jeff?

Sure. Thanks, Liz. So the one thing that I think we're past is the prioritization of getting the vaccine in our age population. If you're 65 and over, and you haven't been vaccinated, then that's a choice that you're making and you're probably coming in and getting your cancer treated. The one thing that Liz alluded to and it still varies throughout the country, are offices opening up to seeing representatives. And I will say this, it's getting better. Every state is a little bit different. Every institution is a little bit different, but it is improving. I've been able to be out in the field and sit in lunches where 20 to 25 folks will gather in the lunch room and it's relatively back to normal, and travel to the next state and there are still some restrictions with regards to access. So I look for that to continually get improved. I always say the importance of face-to-face interaction, especially in orphan drug, Paul, because we are -- the reps are the face of JELMYTO. They are the reminder. They are the -- oh, that's right. I've got a patient that I can consider for JELMYTO. And so that face-to-face access continues to get better. As it does, we're going to continue, as we have in the last 2, 3 months, to increase the number of patient enrollment forms and increase the number of patients to receive JELMYTO.

Okay. Thanks for that, both Jeff and Liz. I guess as you think about the launch progress to date, how would you maybe frame it versus your expectations? And maybe, I guess, the follow-up question here is, are your expectations starting to rise now as things are starting to open up here, you're getting more face-to-face meetings with physicians and potential prescribers and group practices? And so I guess, first, how is it tracking? And then are you starting to become a little more optimistic here?

Yes. I'll just make a comment and then turn it over to Jeff. I was laughing because I again often told that I'm conservative. You're really conservative in your comments, and -- but look, I'm really pleased with what we've done so far and where we've come so far. It's -- I think Jeff and I often talk, what would it have been like even at launch had we not launched in a pandemic, but we met expectations, exceeded expectations in 2020. We talked about the challenges in January and February of this year with patients getting vaccinated. So we saw that happen, and we've seen the difference now. We've seen it, as Jeff commented, in March, April and May. And so I'm going to say I'm cautiously optimistic. I think those are actually also Jeff's words that he uses, but we are -- I mean, the good news about our therapy is it makes it more challenging because it's a treatment, right? It's a therapy. It's not a simple pill or an infusion. So because of that, patients actually have to enroll. So Jeff commented about a patient enrollment form, but that actually gives us kind of an early indicator of patients because you don't have a patient enrollment form unless you have a patient, and we continue to see strong patient enrollment forms. So yes, we continue to be very optimistic, very confident and it's given us a lot of confidence in our ability to deliver on 2021. But even more importantly, the research that Jeff and his team has done really shows that there's a lot of interest in using this medicine with patients. So we expect, as we get over and integrate the therapy into the patient's office and get all of the formulary and get the logistics taken care of, we really expect this to be the new standard of care. So Jeff, I don't know if you want to add anything to that.

Yes. I think what helps too is the time it takes to setup an account. When you're limited to e-mails or virtual-only, it adds a little bit of time. This drug, even without the pandemic, you've got to get it through sometimes a formal formulary process. You've got to be able to go in and develop champions. And so you've got to be able to go in and train on the mixing on the first or second dose. And so as things open up, you'll start to see account setup time decrease. I'm already starting to see it because you can do so much more when you can walk down the hall and talk to the nurse, when you can walk down the hall and talk to reimbursement and coding versus sort of doing everything virtually. I'm very happy with where we are with regards to the pandemic. There's all sorts of data that talk about smaller biotechs not launching successfully. We've done that in an environment where we've had limited access to face-to-face interactions. And so we were able to do that virtually. We're able to continue that. And as things open up, I'm optimistic that we're going to continue this growth. What I say -- what I've said to the representatives is that, and a lot of them actually they said it to me, it's like this is our face-to-face launch in a lot of these territories. This is the face-to-face launch, and they're excited and they're motivated because now I would say it's a fair fight. We can actually go out there, make sure that we're seeing the right physicians, get around the offices, have launches, and we're able to do what we would have done last year at this time. That's why I'm optimistic about the success moving forward.

Great. Could you maybe provide us a little color on where you're perhaps getting the most traction? Is it among academic centers where they have great familiarity with the data and probably follow AUA very carefully? Is it more among community practices or LUG post? Can you maybe just give us a sense for how and where -- how much adoption is going on in particular -- in each particular setting?

Sure. And it's a good question. I can divide it up into 2 parts. So last year, we saw a lot of the business from the academic or the hospital setting. The community is much more sensitive, as you know, to the financial aspects of a buy-and-bill drug. They -- whether they told me this or not, they want to see a J-code, a permanent J-code. And it's not surprising at all that we had that permanent J-code in January, and now you're starting to see more uptake in the community. And so you're starting to see a community urologists use this either through a nephrostomy tube and administer it in the clinic or administer it in our surgery center, and we are starting back to every day. In fact, actually just yesterday morning, I got a text that a big community account in Canton, Michigan, received payment. And when it's a J-code, it's automated. You get -- you should be paid in 30 days. They got paid in 30 days. They got paid accurately. So then when you start to see that reimbursement confidence go up in the community, I expect that to grow as well. But predominantly out of the gates, Paul, it was more in the hospital and you're starting to see that transition into the community.

Great. Can you maybe talk us through a little bit more about the process of getting a new prescriber up and running here? How many calls has it been taking either virtually or in-person now to get that physician on board? And has there been any debate on sort of hard -- you referenced a little bit earlier about setting up offices for mixing drugs and so forth? And just can you maybe walk us through the prescriber setup process here?

Sure. So as far as the early adopters go, it takes 1 to 2 calls. It doesn't -- I mean, their -- when we do our market research, what's nice, we research with about 100 urologists, they all have a place for it. I mean it's the first time ever I've done research, and there hasn't been a handful that say I'm never going to -- I'm not going to use it. There's no place for it. They all have a place for it. The early adopters understand the need to preserve the kidney. They push either a formulary review or they push their administrator to get this up and running. They push pharmacy to get trained. They led the charge. The second group that we're seeing now are those peer-to-peer influencers. So they're in a group of 10, 12 urologists, 1 or 2 use, and then that starts to spread to the other urologists. Where are they using? Out of the gates, it was a recurrent pool. You had patients that had some sort of endoscopic resection, and now they know their cancer is back. And I know what it feels like. The anxiety starts to increase and the physicians wanted another option. They had already done some sort of resection. It was clear that they got what they thought they got it all. But because of the nature of this disease, it's hard to see. It's hard to get everything. And that's why it recurs early and often. We're starting to see now more newly diagnosed. So you see physicians that have used it and hopefully seen success clinically, and now they're starting to sort of open up to our full indication, which, as you know, isn't just a recurrent pool. It's both recurrent and the newly diagnosed. It's both resectable and unresectable. They understand how hard, which is why so many patients get an RNU. They understand how hard endoscopic section can be in this patient population. So that's where we're sort of -- that was the evolution and what we will continue to see. We'll always push to get those later adopters earlier. We've started to see that, whether that's solitary kidney or whether that's -- they've just seen their peers using it and having success. And then with regards to, Paul, you asked about the mixing. As everyone knows, we do have a mixing partner. We heard early on, well before launch, that some of these practices didn't have the capability to mix, and we didn't want to have them -- force them to go to somewhere where they're not as comfortable, which is the hospital. We want to be able to provide the product in the setting they're comfortable, integrate into what they normally do. And so the mixing partner has been great in the sense that they'll mix in the morning and courier it over and the physicians will administer it in their clinic or in the surgery center. So that's been something that's helped us not lose the part of the urologists that really don't want to mix or they can't mix.

Okay. Great. Thanks for that. I guess with level -- you've given us some metrics on reordering and increased utilization, I guess, what does it typically take? Does it take just 1 or 2 patients for a physician to be comfortable with JELMYTO here? And typically, I guess, to this point, what is your sort of, I guess, reorder rate or any update on progress there?

Yes. I think we're up to around 40 accounts that have treated more than 1 patient. It's actually growing on the physicians that have treated more than 1 patient. So that's good, too, because that tells me the accounts, it's just not the same position in an account. You're starting to broaden the depth in that account. You're starting to get more physicians in there. That -- I'm going to keep an eye on that number because that tells me what we put in place from the training, from the reimbursement, guidance and assistance we've been on filling out the form correctly, from the clinical efficacy that they're starting to see that in their patients. And so yes, I'll keep an eye on that number. The latest that we reported in the last earnings call were 40. It's actually growing. It's higher than that. That number is important to me because if we didn't put the logistics and everything in place to make it a smooth process, they wouldn't be looking for other patients. And they are looking for other patients. So that's good to see.

Great. Liz, maybe just you in the past had talked to the importance of the J-code in this population, which is a big driver for utilization among your potential prescriber base. But on the coverage piece, can you maybe remind us, are there any sort of either government or private pay stragglers that are still out there that might represent a chunk of the opportunity that is still yet to come on board from a payer perspective?

Actually, no. The good news is that we're out there. The commercial payers are paying, but the majority of our patients, 70-plus percentage of the patients are actually in Medicare. So that's actually also very helpful. And as Jeff said, the nice thing about the J-code is that it's automated. So I do think that, to Jeff's point, some physicians are going to offices say, "Let me treat a patient. Let me see the payment come in correctly. And then I'll look for more patients." So there is a bit of a time lag that we talked about, but we are seeing that, and we're seeing that work. So we're really pleased with where we are with both reimbursement and coverage. I think it's a pretty easy value proposition for payers. They look at and they say, okay, they can do this treatment or they can go to a kidney removal. And everybody knows that it's not just the kidney removal, that's the problem, right? It's the downstream impact of losing a kidney.

That makes sense. Liz and maybe also for Jeff, as you think about the environment here as we're exiting the pandemic and we've been talking about things opening up, you've presumably been targeting the low-hanging fruit or the high decile prescribers as part of your initial launch effort. So I guess for you, Liz, how do you think about stepping on the gas and targeting that next tranche of potential prescribers? Where are you in terms of your target accounts and rank ordering them? And just when is that process for the next group of -- or the next opportunity of prescribers open up for you? And when you plan to more actively promote there?

Yes. It's interesting. But as Jeff mentioned, I'll let Jeff comment as well, in the beginning, actually, a lot of the academic centers and the hospitals we're using it. The reality of it is the top deciles or your community doctors. So we actually haven't reached that first tranche, right? We haven't really gotten to all of those physicians to adopt because the patients typically see -- and this happens also with oncology as well. You hear more about the academic centers. You hear more from the KOLs and the opinion leaders, but the reality is that patients get treated in the community. So over 70% of the patients get treated in the community, a big part of it is in these LUG posts that you mentioned earlier, the large group practices, and that's where the patients are going in. So we still, as Jeff talked about before, in the beginning, it's really actually been more the institutions. And so what we really have to do is penetrate and continue to work on the community practices and the large group practices because we target about 1,400 of those accounts, but only about 500 of them have the majority of the patients. So we still have a long way to go. The good news is we still have a long way to go in the -- in even penetrating that first group. Having said that, the representatives are out there seeing everybody, right? We see everybody. It's just the frequency and the prioritization, as you can imagine, is in these large group practices, and that's where we need to see the penetration grow and the adoption grow.

Great. Maybe turning to your development and clinical efforts here, you've talked about your development plans for the ongoing ATLAS trial, where are you roughly, I guess, with regard to enrollment here? And then I had a couple more questions on it.

Yes. We haven't actually given guidance on the actual enrollment. As I mentioned before, we actually met our May enrollment. So we have monthly enrollment as we -- and that was really important. That was important because: one, centers are continuing to come on board. As you know, any time you do a clinical study, I have never done a clinical study that actually in the beginning is where you want it to be. And it is a hockey stick, unlike revenue, maybe more of a slow and steady, hopefully not slow, fast and steady, but enrollment in clinical studies, especially big -- global clinical studies like this do become a hockey stick. So as you get more and more centers on board, we actually have high expectations for some of our Eastern European countries. Those are coming on board faster, and we're starting to see that and we are starting to see enrollment. And the reason is because they tend to enroll more patients, even in the U.S. centers. We have more centers in the U.S., but we actually expect that we'll have higher enrollment outside of the U.S. So it's an exciting time for us. We will start to share more specifics around numbers in the second half of the year. But suffice it to say, we feel like we're -- we've hit a good stride, and we're continuing to bring on centers and look forward to that study enrolling.

Great. So it sounds like since you mentioned earlier, you hit your May target, but you're tracking broadly in line with your guidance for completing by around year-end or so?

Correct. Correct. Yes.

Okay. Great. I guess for investors who may be unfamiliar with a non-muscle invasive space here, could you maybe just remind us what is the current treatment paradigm with regard to TURBT? And what are its pros and cons for patients in this population?

Yes, sure. I want to take a step back and talk about, like you said, bladder cancer, non-muscle invasive bladder cancer in total because I think that there is sometimes a miss -- that we're kind of misunderstood. People ask us a lot about BCG, but then our drug, our initial UGN-102 medicine is for low-grade non-muscle invasive bladder cancer. If you think about non-muscle invasive bladder cancer, the actual -- there's about 700,000 people living with non-invasive bladder cancer in the U.S. Actually, the majority of those are low-grade or what they call superficial bladder cancer. And the others are high grade. And high grade is where you're seeing -- that's where BCG gets used, and that's where you're seeing all of the new entrants coming in, the Keytrudas of the world, some of the others that are -- have filed but haven't yet gotten approval, a lot of the studies you see are in high grade and BCG refractory or BCG unresponsive. And what's important is UGN-102, the low-grade patient, there's about 20% of those patients or what we call intermediate risk. Well, what's an intermediate risk low-grade patient. It's somebody who has multivocal disease, they have larger tumors and they recur often. So these patients and about, I would say, 70% of the patient population is actually recurrent. So they recur. And the average time to recurrence is really around 6 months. And so these patients get what we call a transurethral resection of the bladder tumor. Now everybody says, okay, no big deal. It is a big deal, right? These -- again, these patients are in their 70s and 80s. They're coming in for repetitive surgery. They have to go under general anesthesia, and the physician goes in, surgeon goes in and has to cut out the tumors. And Jeff mentioned earlier, he talked about what you can see and what you can't see. And Mark Schoenberg, our Chief Medical Officer, often talks about it like a carpet. It's like, okay, you can see certain tumors, and you can cut out the tumors that you can see. But there are tumors that are there in the wall that you don't see. And what this -- what our drug allows them to do is actually treat the entire area. So these patients go through these multiple TURBTs, and there's some resource that's been done that says 50% of patients would want a new -- an option without even knowing what that option is to going through TURBT again because they've had multiple TURBTs, over about 68% of them have 2 or more. In our study, over 25% have had 5 or more. And so again, this patient population. So what we -- so these patients today against standard of care is this TURBT surgery, going in on general anesthesia, having it cut out and then waiting again, frankly, for it to recur. And so we're offering with UGN-102, an option. And in our study, 65% of the patients actually had a complete response. In the Kaplan-Meier analysis, 72% of those were still durable at 12 months. So we're excited about the opportunity. We think it's another opportunity similar to JELMYTO because, again, you're talking about the upper tract, you're talking about the lower tract. The genetic and molecular makeup of the tract is very similar with the upper tract and lower tract, which gives us a lot of confidence, frankly, in the efficacy and safety of the medicine.

You've designed ATLAS as a noninferiority trial to the surgical comparator. And so could you maybe talk about how -- what your KOL feedback or physician feedback has been on that using a non-inferiority endpoint? You can potentially have the option to demonstrate superiority as part of your trial plan, but can you maybe just provide some context on how physicians view that?

Sure. We actually -- the trial is a superiority and non-inferiority study. So it's not simply non-inferiority, frankly, it's powered for superiority. So we powered the study for superiority. And -- but we also know that patients That physicians want an alternative. As I said, patients want an alternative. Physicians want an alternative, particularly for this patient population that has this multiple recurrences and continuous recurrences. They call them surgical failures because the TURBT surgery just doesn't work. So if they have an alternative, and these patients, unfortunately, there's not a lot of data that has followed this intermediate risk patient for recurrence. And so one of the reasons that we want to make sure we have a superiority and non-inferiority is because there's a big broad range of the patients, right? Patients might be considered intermediate risk, but maybe they're on the lower end, or you have some that will be very severe. And so it's really important for patients and for physicians that they have an alternative. And look, we've been asked a lot about doing an adjuvant study, and we may embark on an adjuvant study. But reality of it is, is the biggest benefit to patients and physicians is if we can -- if they can avoid having the surgery at all, they can avoid going under general anesthesia because we know that just going under general anesthesia multiple times, forget about the surgery, is an independent marker for increased mortality. And so if we can give an alternative, so physicians are very -- and Jeff actually just did some market research that shows the interest in UGN-102 as an alternative for bladder cancer is significant among physicians. And that's what a lot of people not really being so familiar with our medicine.

Great. Could you maybe -- you did speak to enrolling the trial globally here. And I think, could you maybe speak to: first, what is the regulatory alignment between the U.S. and other key geographies? And then what is utilization of TURBT, I guess, on an international basis? And just how do ex-U.S. physicians think about the approach of using a nonsurgical intervention versus the current standard of care?

It's a great question. We actually are meeting with both Japan and European authorities in the next couple of months. So we don't have the feedback from them on our current study, but we want to understand today what are they looking for and we've been really focused on the U.S. with UGN-102 and making sure we worked very closely with the FDA to design the study. Because, to be honest with you, I mean, from our standpoint, we feel like we shouldn't have to go head-to-head against the surgery. We're probably the only company that's ever had to demonstrate the efficacy versus surgery. But we're doing this because it's what the FDA wants us to do. And so we have a lot of high confidence in that study, but we expect to be able to use that globally and -- but we don't have our official feedback yet, but we will work with them. But having standard of care is the same. That's the good news. I mean, it's really the same around the world. Mark, again, has often talked about, it's the technique of the surgeon. But the reality of it is, it's the same around the world. And that's why we can do a global setting, and that's why we can enroll as quickly as we can because we're able to do a global study, particularly, again, as I mentioned, in Eastern Europe, where there are a lot of centers. And they tend to enroll patients in clinical studies much faster and at a higher rate than they do in the U.S.

We have a few minutes left so. Maybe turning to the other parts of your pipeline. You are also having early stage efforts in immuno-oncology. And so can you maybe talk about where you are with regard to developing your CTLA-4 TLR agonist product? And just kind of when could we potentially expect a meaningful update there?

No. No, it's a great question. We're excited about that. Our TLR7/8 agonist was actually something that UroGen acquired quite a few years ago from telematics. And -- but it's something that we did some preclinical work, but then not much had been done. And then when I came in, it's like, we have this opportunity to look at our TLR7/8 agonist, it was becoming a very interesting target for others. And there's always been this sort of story about immuno-oncology, right? Can you take an agonist and antagonist and put them together, right? We often talk about take your foot off the break and put your foot on the accelerator. So did the 2 work well together? And there have been some studies that haven't really worked in this type of agonist, antagonist. And but we have found that in this case, the TLR7 agonist and couple particularly with CTLA-4, we talked about checkpoint inhibitors. We've tried checkpoint inhibitors, and we saw in our preclinical work that in the combination of the 2, they actually work synergistically. And so we're excited about the opportunity to take the CTLA-4 that we licensed from Agenus for the local delivery. So we put the CTLA-4 in our Gel. And -- so what you do is you go in, you give the TLR7 in a water-based solution, and it kind of primes the pump and then you're able to deliver the CTLA-4 locally. And I think a lot of physicians are excited about delivering CTLA-4 locally because, as you know, some of the systemic side effects have caused dose-limiting toxicities. And so the ability to do that locally, and we're pretty excited about. So we are working very closely with MD Anderson, advancing the 2 individually because we have to get the optimization of the dose and we have to get all the talks work done individually before we put them together. So that's the work that's being done now. And so we'll be able to deliver and move into the combination studies in 2022. So I think that likely, we won't be giving any efficacy updates anytime soon in the next few months, but hopefully by the beginning of next year, we'll be able to show kind of where we are individually and then what our plan is, and we're trying to accelerate as quickly as possible the combination. The good news -- well, I'd say, good news, bad news is we're seeing some competition in this area. Others doing some combination. And I think what that tells us is that it really lends credibility to our approach, and we were the first ones to embark on this. So we're excited about this area.

Great. Maybe in our last minute here, Liz, you can talk a little bit about subsequent development and leveraging your RTGel platform here. And you've had some external partnerships and I guess, you have this technology that could potentially be used in multiple settings, including outside of oncology. So just how do you think about BD and partnering here and leveraging your assets that you have right now?

Yes, it's a great question. The RTGel technology, which is a reverse thermal gel that allows the delivery of a medicine to a cavity in the body and then the disintegration over time. So for sustained release and is voided out naturally, can be used actually in many areas. And as you alluded to, we are doing a study with John Hopkins and GBM, excited about that area. I don't think anybody was thinking. It was one of the first ideas that Mark had when I joined the company, is about putting the gel into the brain. And I think that's something that if we -- this is an area of high unmet need. But you're right, in other areas outside of oncology, particularly in urology, we've had people -- physicians, academic centers, other companies looking at it. I think we are prioritizing, obviously, the areas in which we've announced already, but there are others coming in. Our approach will be outside of oncology and uro-oncology, we are likely to -- we would partner that. And we just have to prioritize where we want to be. We want to be a leading uro-oncology company. We want to work in specialty oncology. So we will always prioritize those areas, and we'll work with partners in areas outside of that. And we have a lot of interest, and we'll be able to share that and talk about that, I think, over the coming months.

Okay. Great. We'll have to end it on that note. My thanks to Liz and Jeff and UroGen for joining us for this session. And thank you very much.

Thanks, Paul.

Thanks, Paul. Thanks for having us. Appreciate it.