UroGen Pharma Ltd. (URGN) Earnings Call Transcript & Summary
January 13, 2021
Earnings Call Speaker Segments
Eric Joseph
analystThanks for tuning into the JPMorgan Healthcare Conference. I'm Eric Joseph, senior biotech analyst. Our next presenting company is UroGen Pharma and it's my pleasure at welcome CEO, Liz Barrett, to tell us a little bit about the company. There is a Q&A after the presentation. Simply click the ask-a-question icon to submit it, and I'll ask on your behalf. With that, Liz, thanks again for sharing some of your time with us.
Elizabeth Barrett
executiveYes. Thanks, Eric. Really appreciate you having me. Hello, everyone. It's so nice to be here. I have to say JPMorgan always holds a special place for me because 2 years ago, when I started in this position, my second day on the job, I was actually at JPMorgan, and I think my fifth day on the job, I was actually presenting the company to JPMorgan attendees. And I have to say I'm a little bit more comfortable today than I was then, part of it that I'm sitting in a very comfortable chair over here, but mostly because the last 2 years have just been a tremendous advance for our company but also for patients. I can say that I'm pleased to say that I'm as excited to be here 2 years later as I was 2 years ago, and I'm happy to share our story with you. I know that you'll be following along, so I'll try to do my best to keep on track with and showing you guys where you are, where I am in the presentation. So obviously, the next slide is just our forward-looking statement, as you typically see. So on Slide #3, really talks about the priorities that we have for 2021. I'll talk in a moment about some of our key milestones from 2020 and share more data. But really thinking about what are the things that we have to do in 2021. As many of you know, and hopefully, most of you know, we launched our first medicine in 2020, among the pandemic, I have to say it was a very interesting time for us. But we are pleased that as the launch has gone extremely well, and I'll talk more about that in a moment. But we obviously need to continue the momentum that we've already built and hopefully accelerate the launch as we all come out of the pandemic. But we're really pleased with our early momentum and expect to continue that. Our second goal and objective and priority for 2021 is to accelerate our Phase III study of UGN-102. For those of you who aren't aware, UGN-102 is for low-grade non-muscle-invasive bladder cancer, intermediate risk patient population, which is a much bigger patient population than you'll see with our Jelmyto, our UGN-101, which is for upper track urothelial cancer. And the nice thing about this, our second medicine is that it's very similar. And it has a lot of similarities with the drug that's already been approved on the market and is already doing well in the launch. And I'll talk a little bit more about the similarities, which gives us a lot of confidence as we continue to accelerate that program into Phase III. Then we continue to innovate in this space. As you know, we're focused on uro-oncology. We have an early pipeline that I'll talk a little bit more about with a combination of TLR7 agonist in combination with CTLA-4. (technical difficulty) About RTGel, reverse thermal gel. We actually believe that there's a lot of applications even beyond where we're studying today. We're looking for partnerships. We also have actually had others contact us. We want to continue, with our new Chief Business Officer, Polly Murphy, to continue to move that forward. Additionally, we're working very diligently in both Europe and Japan to be able to bring these medicines to patients around the world. So the next slide just talks about, as I said, our company was built off of reverse thermal hydrogel technology. What's interesting about it is I always talk about the fact that actually the gel was developed to solve a problem that urologists had. And then they really -- with the physiologic and anatomical barriers associated with delivering intravesical therapy into the urinary canal, which gets excreted very fast, an opportunity to be able to develop a technology that allowed medicines to dwell and stay longer and actually deliver medicines for a longer period of time would help to enable, hopefully, patient outcomes. And that was really what the technology was built off of. We've been using it, as you know, in uro-oncology, but it also has applications, as I just mentioned, in other places as well. But it's really important because it's called a reverse thermal gel because it's actually liquid when it's cold. And as it hits the warm temperature of the body, turns into a gel and is able to adhere there, disintegrate over time and is excreted naturally through the body. And so the next slide talks about our program and shows you more in-depth about our program. As you know, as I just mentioned, we got an approval for Jelmyto this year, so it's an approved product. We're in Phase III with our UGN-102 for low-grade intermediate risk, non-muscle-invasive bladder cancer. And our early portfolio includes the TLR7 and 302. And then lastly, in partnership, it is important to note that we still have an active partnership with AbbVie around the toxin proteins and overactive bladder. The next slide, if you think about UroGen and building a company -- and building a biotech company, what was interesting for me is when we received our first approval, obviously, a lot of congratulations from people that actually most biotech companies never get to that stage. And it's not something you really think about, but the reality of it is actually true. And we feel very fortunate to be able to bring these medicines to patients. If you look at building a company and you look at the 2 products that we have, our first approved drug for low-grade upper tract urothelial cancer and our second one for low-grade intermediate risk, non-muscle-invasive bladder cancer, you can see that just with the 2 of those, it's a great foundation in which to build a company. We can have $1 billion peak revenue with just these 2 products. So these are our priorities. We've been focused on bringing these forward. And again, we continue to advance and meet all of the milestones that we had set out over the last couple of years. The next slide talks about really our achievements and upcoming milestones for 2020 and 2021. We received a Jelmyto approval. I think if we just left it at that, that's a big feat for our company, our size, to be able to do. But I'm really proud of the group. If you think about the group that started in Israel and all of the things that are associated, I'm not sure everybody appreciates everything associated with gaining an FDA approval, and particularly around CMC and manufacturing and making sure the integrity of our products as well as the safety of our product for patients. The clinical benefit was very clear. It was very clear to the FDA why this drug needed to be brought to market, which is why we had Breakthrough Therapy as well as Priority Review. And we did get an approval. We launched our drug. We expected to get a J-code, January 1. We got a J-code effective January 1. We had our C-code in October. And we had our top line results on UGN-102, which I'll talk a little bit more about this morning -- or this afternoon, I should say -- and we initiated our Phase III in December, as we projected we would be. And we announced expansion of our leadership team. As I just mentioned, we hired a new Chief Business Officer, Polly Murphy, who's someone I worked with very closely, and she's been very focused on expanding our own portfolio but also looking to expand our technology outside of the U.S. and in other therapeutic areas. So what we should look at for the first half of 2021? It will be very important to continue to watch our commercial launch. I'll talk in a minute more about that, and it's going really well. I believe as we get into 2021, now that we have a permanent J-code that we'll see continued acceleration with that. We actually, as we'll see the publication with the 102 data that we've shared the top line data, but we'll see more in-depth data around that. We'll advance our 302 program with our partnership in collaboration with MD Anderson, which I'll talk a little bit more about that, and we'll continue. We have a lot of interest from others, from other companies, from other academic institutions, and we expect to continue to evolve our partnership strategy. As we move into the second half of 2021, we'll be hopefully giving an update on ex-U.S. in the second half. We'll continue to enroll and provide enrollment updates on UGN-102. It's really important, as we've said, that enrollment will take us 1 year. I am pleased to say that our sites opened, and we are currently screening patients and very excited about that and we'll continue to move forward with potential collaborations and partnerships. On the next slide, just, I guess, 2 more shows you talks about our launch, and this is Slide #9. And the approval of Jelmyto, again, approved in April, but launched in June. And as I think most of you know, if you're familiar with our product, you realize that it's actually not a typical infusion or a typical pill but it's actually a drug that has to be delivered through a procedure. So it's a little bit more complicated and complex. And one of the things that we worked very hard on and the commercial team did a phenomenal job of ensuring the seamless integration of our medicine into the doctor's practice. And what's interesting for urologists, they're used to these types of medicines. They do these types of procedures a lot. But not everybody is aware and understands the logistics that go along with it. So the team has done a very, very nice job of doing it. And we quickly pivoted. As you can imagine, Jeff Bova, our Chief Commercial Officer, and I in March, we said, well, we better be prepared even though I can tell you that both of us thought that it wouldn't last as long as it has. And that even though we might have to launch initially, virtually, that we would quickly be in back in the physician offices where you can -- as I think everybody knows, we're continuing to do things differently. And I think we'll continue to do things differently even after the pandemic. We've seen a lot of success, and the team has done a great job. And we've also had very great partners in our physicians who've been interested in learning more about Jelmyto and interested to see how they can adopt it and bring it into their practice. So again, we've seen very, very nice uptake. NCCN guidelines was updated within 2 weeks of approval, showing the clear unmet need and the advance that this drug brings. We shared in Q3 of '20, our revenue of $3.5 million. The other thing that we've been talking about a lot when you think about revenue, as we've shared even as late as December that if you look at the consensus estimate, we feel very comfortable that we're in the ballpark of that, both for 2020 and 2021. We still feel really good about that. And we think once our numbers are finalized for 2020, that you'll be pleased to see the progress that we've made in Q4. Getting back to the data, the data was very compelling, which is the reason we were able to get such a quick and rapid approval from the FDA because they recognize that these patients typically have to end up getting their kidney removed. They're an elderly patient population. So if you have the ability to bring a new medicine to these patients and let them delay or avoid having their kidney removed. But that was a real advance in patients. And they had talked about a 20% to 25% if you can say, 1 in 4 or 1 in 5 kidneys, that's clinically meaningful. We had a 58% complete response rate. In Kaplan-Meier analysis, 82% of those expected to be still in complete response at 12 months. And we have not reached our median duration of therapy. So the next slide talks a little bit more about the patient population, Slide #10, for those of you watching and on the phone. Jelmyto potential to avoid kidney removal, as I talked about. It's a primary chemoablation medicine. The patient population is made up of about 6,000 to 7,000 eligible patients in a year. And that's about half of those are the newly diagnosed and about half of those are recurrent patients. There's about 15,000 patients actually living with a UTUC and about 20% to 30% of them will recur in any given year. Next slide. Again, the launch update, as we've talked about. Now we have over 210 practices or hospitals that are activated. What do we mean by activated? Well, they've either treated a patient, they've identified a patient or they're ready to go as soon as they do identify a patient. And that just means that they've gone through logistics. They've gone through the practice approvals that they need. They need to have, as you know, it takes time to get on formulary in some cases. And so we have 210 activated accounts, really happy with that. We also have some more recent update on some market research, where we've had 80% of physicians now expected to prescribe Jelmyto over the next 12 months. So that's a very high number, if you've seen others and other medicines in this area and other therapeutic areas, 80% is a great number. We've seen our -- actually, awareness go up to over 90% and unaided awareness over 50% -- and I mean an aided awareness over 50%; unaided awareness. So we're really thrilled with that. Reimbursement, we've had some great success with reimbursement. And now that we have a permanent J-code, that will make that even easier. Jeff likes to talk, our Head of Commercial, likes to talk about accounts that have treated more than 1 patient. And why is that important? That's important because, obviously if they've treated a patient, they've treated a second patient, then things have gone well from a logistics standpoint. They're happy with the procedure, and we have 24 accounts that have actually treated more than 1 patient. So next slide as we get into UGN-102, this is Page #13. Again, very similar, as I've talked about, very similar UGN-102, but it's for intermediate risk low-grade non-muscle invasive bladder cancer. These patients today, I'll talk more about that, tend to go through repetitive TURBT. The new patient population, it's about 20% of the total patients. There's about 700,000 patients living with bladder cancer. And of course, you have your low grade. You have your high grade. You have your newly diagnosed. You have your recurrent patient population. But when you look at those patient populations and see the patient population that we're studying in 102 and that are most eligible and, frankly, a most high unmet need for a new treatment of these patients called intermediate risk. So next slide. And just to comment that we often get asked about BCG. BCG is not really used in low-grade disease. It's really reserved for high-grade disease. So the next slide, improving patient outcomes with non-invasive, durable option. The durability is very important as we get into these patients. And as I just mentioned, about 20,000 newly diagnosed and about 60,000 patients that are recurrent patients. Next slide. What's very interesting is the research we've started to work on in preparation for building this market because this is a new market, just like Jelmyto was. These patients today go through surgery, but 68% of patients that have 2 or more recurrent. And it is known that if you have repetitive TURBT, you are more likely to recur there faster. We also know -- we have some data to support, but there's an increased mortality, a 14%, independent of surgical risk in patients that have these repetitive TURBT. We also have research where physicians will just say 25% of my patients just should not be having surgery. They're either elderly, they've got comorbidities. They should not be getting general anesthesia. So that's like today. That's before -- that's not saying as an alternative, they're saying these patients should not be getting surgery. And we have a survey that shows that 45% of patients are saying, if I had an alternative, I would be interested in alternative. And all of this data, what's really important about this, this is really before we've started doing any of our market building activities for UGN-102. So next slide, Slide #16. As I mentioned before, the current standard of care is TURBT, transurethral resection of the bladder tumor. This intermediate risk patient tends to come back. They cycle through time and time again. And it's amazing when you look at some of the data, some of these patients had 10 and even up to 20 TURBT surgeries over many years. So the ability to have a new medicine available to them and a therapy that available to them, that is an alternative to the comorbidities associated with surgery, but also one that works as primary therapy because the idea here is that in this patient population currently what they have doesn't work. And the data is very compelling, 58% CR, 82% duration of response in Jelmyto and very similar in UGN-102 with a 65% CR and 72.5% duration of response. So next slide talks really about the durability, which I just showed. I know I see that a reason I'm rushing now is my timing is starting to run out. So I want to quickly be able to talk to you about 102. I think we've shared a lot about -- I mean, about 302 -- shared a lot about 102 and the durable responses that we've seen. So we're really pleased. And what we've done is we've taken that information and designed our pivotal study for our Phase III study for UGN-102, the ATLAS trial. And what it is, this is UGN-102 plus or minus TURBT versus TURBT alone. And the reason I say plus or minus is because, if a patient isn't at a CR after using UGN-102, they will get a TURBT and we will follow them. It is important to note that the primary endpoint for this study is disease-free survival. So it's great. We want to try to get as many people as we can as CR, whether it's UGN-102 or TURBT, and then we want to follow those patients for durability. So the next slide, then -- I skip that slide and go to Page 21, which talks about 302, as I said, where this moves us from low-grade disease into high-grade disease. And look, there are new therapies that are coming out for high-grade disease. We're really thrilled to see that for patients. But still, there still remains a high unmet need because most of these patients have a very low response to those new therapies, and we really want to be able to bring new treatments to these patients. So the next slide just talks you a little bit about the patient population. About 25,000 are newly diagnosed and about 15,000 of those patients are BCG refractory. So next slide, what's interesting about 302, and it's on Page 23, is that we've really seen, in our preclinical models, the synergistic effect of having an agonist in our TLR7, an antagonist in the CTLA-4 being able to deliver those -- locally deliver those. And one of the reasons we really wanted to work with MD Anderson is, as you know, Dr. Jim Allison and Dr. Padmanee Sharma, they have a significant amount of experience and expertise. And Dr. Allison, as you know, is recognized with a Nobel Prize for his work in immunotherapies. And we believe the expertise, the infrastructure that they have, bringing our molecules and our infrastructure to bear, and us working together, we'll really be able to accelerate this program and put it in a place where we can make the most benefit for patients. So as we start to look ahead for what's in the future, the great thing about our company is the team has done a very nice job of ensuring broad IP estate across the board globally for our medicines into the 2031 and beyond. As I mentioned before, we're very focused, on Page 26, on business development, both geographic expansion, expanding in the uro-oncology space, expanding into special oncologist -- oncology and partnering with our technology into other therapeutic areas. And then lastly, before I turn it back over to Eric for his Q&A is that we're in a very good financial position. We shared -- $3.5 million of revenue after Q3. Our Q3 results, $125 million of cash and cash equivalents taking us into 2022 with about 22 million shares. So with that, we're really thrilled, like I said to be here. We feel like the company has made a tremendous amount of progress over the last 2 years with so much more to come. So with that, I'll stop and turn it over to Eric and the team and hopefully answer any questions that you might have.
Eric Joseph
analystGot it. Thanks for that presentation, Liz. I guess just picking up on the progress with the Jelmyto launch, as you talked about, the challenges with the pandemic are still with us. So just kind of curious to get a little more color on sort of how the team is managing through, particularly as sort of base rates and a little bit of uncertainty of the course of the pandemic kind of proceeds kind of with us and how the launch team is -- or the commercial team is managing through that? And I guess, secondly, sort of looking behind accounts where you've seen reorders, have you also -- any signs at this point of maintenance use of Jelmyto, sort of retreatment beyond that initial induction course of therapy?
Elizabeth Barrett
executiveSure. Great question. I will say, in the beginning, that we have a receptive audience. As I mentioned, launching in a pandemic is not as -- it can be challenging, but the good news was with that physicians were interested. So they were able to engage and they were willing to engage us just as we're engaging on Zoom. So we actually found that we had quite a bit of time, that's one thing. The second thing is these patients have cancer, right? So they might be able to delay it a little bit. They may be able to delay it, but they need to see a physician. So those 2 things have actually worked in our favor, and being able to get out there with the physicians and be able to sort of educate them on Jelmyto and actually provide an alternative to these patients going into the hospital to have surgery, right? So it was sort of like, while we would like -- would have loved to have engaged face-to-face, we do find that it's also a benefit to have a medicine that gives you an alternative to have to go into the hospital in this -- during this time. The good news is, I guess, at its peak, we were finding that we were kind of not able to do much in about 50% of the account. But actually, the latest research we have is that only about 30% of the account now are where we're not able to get in. Now of course, that could change over the next couple of months. We want to be very careful about that as you've seen the resurgence of COVID in certain areas. So it's a very geographic specific. And then the other piece of that is, at least for me, I'm hoping that the vaccines -- everybody gets the vaccines, especially health care workers and people that have these types of diseases will be the first in line to get their vaccine and be able to get treated. So we are seeing, as I said, better access, right? Access is getting better, and we're able -- and patients are getting in there more. On your second question around maintenance, we have not -- of course, it's early. We have not been promoting maintenance. It was always our position all along that we felt like the important thing was to get the 6 doses. Having said that, we have had some physicians that have been interested in maintenance, but it's too early right now to tell how many patients will really -- I mean, how many physicians will really want to use maintenance. And it may vary from patient to patient, right, depending on whether the patient -- they feel like the patient can tolerate it, and how often they want to do. So I think that as we continue to see actual real world experience, we will be capturing that experience and be able to report that back.
Eric Joseph
analystOkay. Okay. I guess from a coverage standpoint or a payer standpoint, maintenance use isn't -- or you're not -- don't anticipate, I guess, getting payer pushback on the point -- on the potential for maintenance use.
Elizabeth Barrett
executiveNo, we don't. And we'll get covered.
Eric Joseph
analystOkay. Okay. Okay. And I guess, sort of -- as you think about sort of life cycle management opportunities for Jelmyto, in particular, is that sort of looking at opportunities beyond maintenance? I guess how to think about life cycle, yes, right with Jelmyto specifically?
Elizabeth Barrett
executiveSure. No, absolutely. I think there's probably 2 areas. One is in retreatment. We've talked before about wanting -- we actually tried to do a retreatment study based off of our pivotal study, but there just wasn't enough patients. And the good news is those patients weren't recurring. So I think that that's one area we will definitely want to do. We can't start that study now. But towards the end of the year, hopefully, we'll be able to start that study as patients come in and get therapy and then recur. And we actually do even know, at least, I'm aware of a patient that was in our clinical study and was -- also got Jelmyto again after they were recurrent. So they were in, they were in complete response for quite a while, did well. And we -- so that's something we definitely want to study. I also would like to study those patients that got a PR, a partial response. And if you were able to give -- speaking of maintenance, but if you were able to give those patients 1 or 2 more treatments, would they potentially get them from a PR into CR? And then the last thing I'll talk about -- I said 2, but there's really 3 -- is the nephrostomy tube. What we're finding is that even though no one used it in the clinical study, it is in our label. And we have found during the initial launch, probably because of COVID, because it can be done in the doctor's office, that some physicians are using delivery through a tube, and that's -- so we'd actually like to gather some data on that and be able to share that more widely.
Eric Joseph
analystOkay. Okay. All right. Pivoting to non-muscle invasive bladder cancer with 102, you recently updated -- provided an update on the CR durability from the Phase IIb OPTIMA trial, showing a 12-month durability rate of 72%, 73% by Kaplan-Meier. I guess how do -- a bit of an apples-to-apples or just comparison again with where we sort of initially saw a follow-up at AUA. How do we sort of compare durability of CR, and how that's kind of progressed? And just kind of putting some context around that, how does that compare with what physicians would expect with TURBT [ in the center ]?
Elizabeth Barrett
executiveYes. The -- what's interesting about it is before we ever saw any data from 102, and we were being asked about 102, Mark and I both said, hey, look, if you -- if we had a 50% complete response and 50% of those patients were still in remission at 12 months, that would be meaningful. So I'd say that kind of puts it in -- the 65%, and the 72%, 72.5% -- in context. The other news is that we don't expect to see that change much, right? What we saw with Jelmyto and what we've seen with 102 is, as we've shared data, it's been very consistent, and that's good news as well. Now to your question about what you would expect with the TURBT, some people are going to say that 100 -- you get a 100% CR with a TURBT. Well, that's not really true, but let's just even assume that is true. The more important way to look at it is how quickly those patients recur. And that's -- we know by blue light technology that really they missed about 20% of the tumor. And so even if you're talking about an 80% to 100%, you get them to CR, what's really more important is that these patients that cycle through, you get them into CR, but you're only in CR for 3 months or 6 months or 9 months, and they're back in again for TURBT.
Eric Joseph
analystOkay. Okay. And digging into the stats plan for the Phase III ATLAS trial, how -- I guess what criteria define the patients that would be evaluable for the primary endpoint of disease-free survival? Is that being assessed sort of on an intent to treat patients? So patients just sort of that were all randomized or is it among patients that achieved a CR following their first treatment with either 102 or TURBT?
Elizabeth Barrett
executiveSo we will follow all patients that are randomized in the study, obviously. What's interesting about the way that the design is, it's a little bit complex, and this is really based off of the FDA feedback and being able to ensure the viability of our statistical plan, right, is that at 3 months, you want to try to get everybody into CR. So those patients that are -- that will get a CR with UGN-102, the 65%, as an example of our Phase II, if they're not in CR, they will get a TURBT with the belief that now you put those patients into CR. And you would follow all of those patients for disease-free survival. If they have a TURBT, they come in at 3 months, okay. We could argue, close to 100% of those would be at CR. It will be interesting to see what that number is. But any patient that has a TURBT, a TURBT doesn't go into -- will have another operation at 3 months. So you'll either have -- so in one way or another, you're pretty much trying to get a 100% of your patients into CR at that 3-month mark. And then from there, again, we will follow those patients for disease-free survival. So you're really looking as close to apples-to-apples as you can.
Eric Joseph
analystOkay. That's helpful. Yes. And I guess with respect to the planned interim analyses, is the planning that you are still -- that there will be 2 interim analyses in the trial? And I understand they're event-driven. But I guess, like when they are -- how should we be thinking about sort of the results of those interim analyses being reported -- I guess, the disclosure practice when it comes to those interim updates?
Elizabeth Barrett
executiveYes. I think it's really better to think about the study in the context of the full study. I think we should assume that we're going to -- we will go the full way. We built in these interim analysis because we do know -- one of the reasons is because there's not a ton of data around this intermediate risk patient. You have -- we have more and more mounting data talking about that patient population. But if we are able to get superiority, you really would not -- would want to shut that study down as soon as possible so that patients, you can move to make this available for patients. So we've built in the analysis using our statistical plan. We don't have a timing of when those -- we don't have a projected timing of when that would happen. But reality of it is that I think it's best to think about it that it will go the full way with a 2-year follow-up. And at that point in time, we'll be looking at both non-inferiority and superiority. But absolutely, it makes sense for us to build into the plan, the ability to take a -- to look. As you know, as you don't build it in, then we would lose some of our power. So it was important to build those in ahead of time.
Eric Joseph
analystOkay. Okay. Great. What's the competitive landscape looking like in lower grade or low-grade intermediate risk? You have a fair amount of drug development taking place in the higher-grade setting; not a lot, I guess, is lower grade. So how do you kind of expect that to sort of...
Elizabeth Barrett
executiveNo. I think that's the good news for us, right? Good news for us is there's not much competition. There are a couple of other companies that are looking at it, but they're very early. And so we -- there's one company that's out there a little bit later. But for the most part, we're the only ones that are in this space where we're close to being in a pivotal study or our Phase III study.
Eric Joseph
analystGot it. And I guess, operationally, sort of what kind of challenges does the pandemic pose here? Yes. You kind of have a little bit with the Jelmyto experience, but I'm just kind of curious to get a sense of how things are going in terms of getting sites up and rolling and so forth in anticipation of...
Elizabeth Barrett
executiveRight, whatever happens. So that's...
Eric Joseph
analystYes, whatever [indiscernible] we're ready to [indiscernible]
Elizabeth Barrett
executiveRight. We have to be prepared for everything, right? The team has done a nice job. We made some decisions in 2020 to make sure that we increase the number of sites. We actually also went to Eastern Europe to have some Eastern European sites that are -- could be high enrolling sites. So if you find any geography, whether it be in Europe or whether it be in the U.S., be in a situation where they're shut down for a while, at least some of the other sites could pick it up. And so for that reason, we actually were, frankly, oversubscribed for this study. What I mean by that is we had more centers interested in participating than we could actually get them on board right in time. So -- but we have to identify that, of course, it's a risk, right? Is it a risk to enrollment, the rate of enrollment? Absolutely, but we've done and put in place a lot of things to be able to overcome any challenges that we might have with enrollment because enrolling these patients in a year is really important for us.
Eric Joseph
analystGot it. Got it. And I guess just picking up on the press release early this morning, this collaboration with MD Anderson, can you just sort of talk to sort of the goals of that collaboration there? And yes, sort of what you might learn through to the collaboration?
Elizabeth Barrett
executiveSure.
Eric Joseph
analystSort of the progress of that collaboration.
Elizabeth Barrett
executiveAbsolutely. Right. Absolutely, one of the things about the UGN-302, which is a combination, right? It's a combination of 201 and 301, so you have to study 201, you have to study 301 and then you have to study the combination. And so being able to tap into the expertise and the infrastructure and the lab and the translational medicine expertise that MD Anderson has to kind of guide us as to what studies we should do, what we can do in parallel to ensure we expedite as quickly as possible, they have that expertise, right, that is not within UroGen. So we take our expertise that we have with our gel. We take the expertise that we have, obviously, in urology with Mark Schoenberg, our Chief Medical Officer, and marry it with the expertise that MD Anderson has, we believe that that will allow us to know that we're going down the right path, we're doing the right study so that we ultimately will get the best outcome for patients.
Eric Joseph
analystOkay. Okay. Great. Great. I think we'll leave it there for time. But thanks, Liz, for sharing some of your time with us. That's really appreciated. And thanks, everybody, for tuning into the webcast.
Elizabeth Barrett
executiveThanks, Eric. Take care.
Eric Joseph
analystYou, too. Bye-bye.
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