Good morning, everyone. We'll continue with the next session. My name is Paul Choi, I cover the small and midcap biotechnology sector here at Goldman Sachs. It's my pleasure to welcome UroGen to the conference here. Joining us from management here on stage, to my immediate left, is Dr. Mark Schoenberg, CMO, and to my far left, Jeff Bova, Head of Commercial. Also in the audience here, we have Dong Kim, who is the CFO. What we'll do is continue with the usual format. Maybe I'll turn it over to Mark, maybe to make some high-level comments on the company, and then we'll go into Q&A. If anyone in the audience has questions along the way, please feel free to raise your hand.
If you have, for those who are listening on the webcast, feel free to email us questions, and I'll be happy to read them anonymously. Either to Mark or Jeff, maybe if you want to maybe start with some high-level comments on what maybe the outlook is for this year, we'll get into Q&A.
Sure. Well, first of all, thanks for having us, and it's a pleasure to be here. From a medical perspective, this is a very exciting year for UroGen. We have a number of phase III programs that are coming due, and we expect data to be announced this summer. Very interesting for our bladder program. We also are advancing our phase I program for an immuno-oncology asset, so interesting research and development. Then, of course, Jeff may want to comment on this as well, real progress, in the commercial, area.
Sure. From a Jelmyto standpoint and how the launch has been going, we recently had some significant data come out. The real world evidence data was presented at AUA. It really is how physicians, how urologists use Jelmyto, where they're trying to preserve the kidney, they endoscopically resect, they bring in six doses of Jelmyto. The operational lift, Paul, we talked about this, has always been a challenge with Jelmyto, improved greater that in times of COVID. Starting to see some real momentum, getting through the operational lift, physicians are using, and then, more importantly, looking to find other patients that can benefit Jelmyto. AUA was a great success as well from a guideline standpoint. The AUA had never had UTUC upper tract guidelines.
They now have published those, and they've reiterated what we've said for four years, but it's one thing for us to say it's another thing for their colleagues to say it, is that you should do everything possible to spare the kidney in low-grade disease, which means some sort of ablation, whether that's endoscopic ablation, or chemoablation with Jelmyto.
Okay, great. Lots to unpack there, so maybe just continuing with the commercial dynamics, Jeff. I guess you talked about sort of a tale of two cities, COVID and sort of post-COVID, and as well as, you know, sort of the changes that have gone since AUA. Can you maybe provide us sort of a high-level update on recent commercial dynamics and sort of maybe starting with the breakdown of doctors who are using Jelmyto to date, and maybe I have some follow-ups after that?
Sure. I think what we're starting to see is time to identify first patient to actual treat is shrinking. Time to identify, to treat when they're operationally set up, they've been trained, they've had it on formulary, we see that now at two-three weeks, where that was significantly longer, one year ago, certainly two years ago. The other thing is that we're starting to see is with the real-world evidence, we're starting now to have evidence that sells our entire indication. Whereas a physician may have only used us for recurrent, unresectable, the real-world evidence is just another data piece that allows the representatives to go in and speak to new data that are how they treat right now.
We're starting to get a little momentum there. Now what I see is more consistency. You've heard me mention PEF, patient enrollment forms, more consistency on growth week-over-week. Then when we do have a down week, it's not significant. We're starting to see some of that higher level adoption that we would have expected in a non-COVID environment. We're starting to see that now.
Okay, great. In terms of, like, where Jelmyto is being used, can you provide us maybe some context and background on where it was used initially and how that adoption has maybe shifted between, let's say, academic practices versus large group practices, and community setting and so forth?
Sure. I would say it does follow the label and that it's being used everywhere in the label. Where it's predominantly being used is urologists go in, get what they can see, and then come back with six doses of Jelmyto. What we saw in the real-world evidence is that increased your CR over what we saw in OLYMPUS. Remember, in OLYMPUS, you had to leave tumor behind so you could prove that Jelmyto was having the effect. In real practice, urologists don't leave tumor behind, they're going in, getting everything they can see. They come back with what we call, from a marketing perspective, multimodal therapy. Do everything you can to preserve that kidney.
They go in, they get what they can see, they come in with Jelmyto six doses to get what they can't see. That produced a bigger CR. That is predominantly over 50% of how Jelmyto is being utilized. Having said that, it's being utilized in newly diagnosed, it's being utilized as monotherapy, unresectable patients, that kind of makes up the rest of the utilization.
Okay, great.
Primarily.
In terms of physician breakdown, in terms of setting... Sorry, going back to my earlier questions.
Yep.
Is it more academic, or is it more like large group practices?
Great question, like, just this last quarter, we saw a shift. Typically, we've seen between 50% and 60% of the administrations are given in the hospital. For the first time, in a quarter, we've seen that less than 50%, I've seen the clinic now they're given nephrostomy tube in the clinic, start to peak up, to move up to around 30%. The hospital has come down, the clinic and the ASC has gone up. I expected this, probably a little sooner than where we are now, you're starting to see that. I think that trend will continue.
That's great. Maybe just continuing on the commercial piece, with you, Jeff. You've targeted, you know, in terms of your launch, a set group of high-volume prescribers and sort of the ideal physician practices. Where are you with, perhaps, targeting physicians who are not using Jelmyto yet? You know, how has that progressed to date in terms of expanding into a sort of a larger prescribing population?
Sure. Now, as you had asked one of the questions here, like, how many call points do I need on a physician to change behavior? For that physician who's looking to preserve the kidney, it doesn't take a lot of calls. It takes anywhere between five and 10 calls. More importantly, it takes that operational lift that we talked about. There are still, what I believe, 20%- 30% of patients that are having their kidneys removed. That's a longer call point. That I've got to hear. The nice thing is, I've got to hear more data, so we've got that. I've got to see my colleagues using it in the office, so we're starting to get that.
You're starting to see the number of RNUs continually go down, which is what we want, and then we want to be a partner with endoscopic resection. That adoption curve is slower because they're physicians that are used to or wanting to pull out the kidney. In fairness, there are patients who choose to have their kidneys removed. Those adoption curves are smaller. They've been picked up a little bit more because we've increased our marketing efforts, you know, to use a little bit more provocative language to... It helps to have more data. I for the longest time, we've had OLYMPUS, which has been good, but just in the last six months, we've now got the Rose paper that talks about antegrade.
You've got the real-world evidence that talks about how they were currently using it. Yeah, that the slow adopters, my hope is it picks up a little, but those that have adopted really are doing an aggressive find for those patients just because it is a smaller syndrome.
Okay, great. You also spoke to something that maybe is not appreciated as well, which is finally guideline changes after. This is something that's come, you know, a couple of years post-approval and post-launch. Maybe you could just sort of frame for us, you know, has that been a measurable impact, I guess, to this point? I know it's been relatively recent, but do you sense a tailwind coming from medical societies and having guidelines recommending Jelmyto now?
I would say it can only help. For the physician, you know, some urologists look at the guidelines, others don't. It's a talking point that allows the territory business managers to go in and say, "We're on guideline," and talk about those guidelines. The biggest thing for me is they've basically been saying what we've been saying, Paul. I mean, we've, in our unmet need campaign, prior to approval, we've been saying, "Don't pull low-grade kidneys." The AUA has helped reiterate that.
For me, it's more of a door opener, and then the rep takes it from there versus it's, "Well, we're on guidelines." I mean, the AUA was slower to come out with the guidelines, but the fact that they have the guidelines now, and we're in the guidelines, is certainly a door opener and an avenue for the representative to go in and talk about it.
Okay. Maybe one more for you, Jeff, before we pivot to some of the clinical stuff with Mark, which is, can you maybe describe how you've changed the process and made it somewhat easier for physicians to use Jelmyto? How has your process and, you know, interaction changed over time? Secondly, you know, after a doctor initially tries it, what does it sort of take for them to become more, more of a regular user and repeat prescriber?
Sure. Great. First question was, the one thing that we've done is we have a team now of operational managers that do. When they find a patient, it's a lift to get everything in place for operation. Then that lift takes time away from the representative to go drive additional demand. Now, we hand that off to a team of operational managers that works with our wholesaler, that works with the distributor, that works with the nurses to get everything set up for training. Now you remove that lift, and the TBM, the territory business manager, now can go out and do what we need them to do, is drive further demand.
The second part of your question is where we see rapid and growth is sort of the first couple patients come in, they're reimbursed accurately and timely, obviously important for a physician. They hopefully see the efficacy and success. What we see is sort of doors open to finding and mining for more patients. They know they have the patients. It's really about the relationship with the nurse, the nurse navigator in each practice, to help us say, "You think about three to five of these patients." When you go in and sit down and run specific codes, the nurse comes back and says, "We actually have closer to 10 to 12 of these patients." You get physicians looking for them more actively.
That's where, that's where we've had the biggest success, is letting us show you, help you realize that you have a lot more patients than you think you have.
Great. Mark, you referenced earlier that, you know, we're going to be in sort of a data-rich period coming up here in the, in the near term, in the low-grade, non-muscle, invasive space. Can you maybe update us on, or refresh us on, you know, how these patients are currently treated, what sort of the available options are, and sort of what are sort of the gaps, you know, based on the, on the current treatment paradigm?
Thank you. This program, our non-muscle invasive bladder cancer program, is predominantly focused on patients who have low-grade our recurrent disease. The standard of care for the management of this patient group is transurethral resection, which is an endoscopic surgical procedure performed under anesthesia. Remember, also, this is an elderly population. Average age of diagnosis is 74. These are people who are not ideal candidates for repetitive surgical intervention, but unfortunately, because of the nature of the disease, that is exactly what they get. Because there has been relatively lackluster adoption of adjuvant chemotherapy in this population by U.S. urologists, these patients typically cycle through a series of surgical procedures throughout their lives, don't die of the disease, but do enjoy very intensive bladder cancer surveillance and intervention when recurrence occurs.
The unmet need, as we understand it, and I think urologists generally have understood this for a long time, and certainly the urologists on our board understand this, is the problem with managing a disease that is not life-threatening, but is expensive and requires a lot of care. Our current therapies are associated with some real morbidities that are undesirable, and particularly undesirable in an elderly population. A non-surgical alternative would be very welcome for this group of patients.
Right. Certainly, a potentially expansive white space for UroGen to play in here.
Indeed, yes.
In terms of the population, you gave some characteristics of the typical patient. You said it's in the mid-70s and... Just in terms of, like, the market sizing and the market opportunity, what is sort of the U.S. prevalent population or incident population? You know, how should you suggest investors size up that opportunity?
Sure. This is an area that always surprises me because the numbers are sort of astronomical. The prevalence of bladder cancer in the United States is about 800,000 patients. For the particular population we're dealing with, namely those with low-grade recurrent disease, we estimate that there are probably around 400,000 people in the United States in any given year who are being treated at various phases of this disease. There are also probably 30,000 new cases annually of low-grade recurrent cancer. As you can see, there is a robust population of patients who need additional therapeutic options.
Yeah. Maybe just putting your clinical hat on, you mentioned, you know, there hasn't been much enthusiasm or approaches for adjuvant chemotherapy here. Clearly, the, you know, just this is always a question that's fascinating. Why hasn't there been sort of more systematic development? Just from your perspective, you've been both in the academic and a corporate setting here, so I'm just curious why urologists haven't thought about this approach more?
Yeah, I think-
Mathematically.
Yeah. I think urologists have thought a lot about it, particularly academic urologists, I think, and Jeff is probably going to want to comment as well on this. There are a series of barriers. Some of them are academic, and some of them are practical to the adoption of intravesical therapy. I'll give you an anecdotal experience at our hospital that I think crystallizes why adjuvant therapy is somewhat problematic and underutilized. The incremental benefit of adjuvant therapy is relatively modest. It's probably a 10% decrease in recurrence rate when used appropriately according to guidelines. However, there is cost, Jeff is probably going to want to talk about the way cost is managed with respect to purchasing the drug and how it's viewed within the context of the procedure.
Secondarily, there is the concern of actual incrementally increased morbidity in using these drugs after surgical procedures, where leakage of the drug outside of the bladder could, in fact, cause very untoward side effects that are long-lasting and difficult to manage. Do you want to talk about the bundling, though, a little bit?
Sure. From a community standpoint, when the physician goes into the hospital to deliver a TURBT, they're already... It's, it's not, from a financial standpoint, extremely lucrative. If you were to give mitomycin in an adjuvant setting, oftentimes it's bundled into that current payment, so it takes away from anything that they would be receiving. More importantly, I've asked: Well, what about waiting for the bladder to heal and bringing them back to the clinic and delivering it in that setting? They've said what Mark just said, that the 10% is really not worth the incremental benefit, and they're surgeons, and they'll just do surgery again, in six to nine months, if it recurs.
Okay.
There's a final consideration that's logistical. These are medicines that have to be mixed in special environments, and not everyone has access to those special environments. That, in fact, is actually the major barrier at our hospital to using this medication.
Okay, very good. As you think about UGN-102, Mark, I guess, and the features that you've developed and the clinical programs that you developed, what makes you most excited about this, I guess, as you think about it, you're obviously, you know, thinking about it both from the corporate perspective, you are also a practitioner, I guess, what makes you most excited here?
Thanks for asking that because it's actually very exciting, and I think there are two parts to the answer. The first is the practical availability of an alternative to a surgical procedure that is really the only alternative for patients currently. There's a bigger idea here that I think, you know, we've talked about on a number of occasions, and I sort of view UGN-102 as the robot for bladder cancer. This is a new way of thinking about this disease. We know, and in fact, I was talking to Arie Belldegrun, our chair, about this recently. There, we've known for a long time that bladder cancer, at least this form of bladder cancer, is a chronically recurring disease that we treat in an inadequate fashion, and we do that and have accepted that only because we had no alternative.
In fact, there is emerging evidence from molecular biology experiments, as well as cumulative clinical experience, that really supports the idea that a complete urothelial therapy, like UGN-102, is in fact likely to be the game-changing and, in fact, paradigm-shifting intervention that we've been waiting for this group of patients. I think it's exciting because it represents a big idea, consonant with a movement in urology toward organ preservation, less invasive therapy, less morbidity. I do think and I feel like we're on the cusp of being able to realize a real step forward for this patient population.
Okay, great. Maybe, reviewing your clinical programs, can you review for us, you know, how the clinical program has evolved over time between ATLAS and ENVISION? You know, what are the differences between the studies and, you know, what was the particular rationale from pivoting from ATLAS to ENVISION here?
Sure. Just to sort of set the stage, we had a very positive phase II experience that was called OPTIMA, and that was a single-arm open label trial in patients with new and recurrent intermediate risk disease, this chronically recurring problem. 65% complete response rate, durability by Kaplan-Meier at a year being 72%. When we went to the agency for discussion of a phase III program, they felt insistent that a randomized trial against surgery would be the appropriate step forward. Although we had reservations about that approach, we actually initiated that trial and enrolled hundreds of patients in it, although we continued to talk to the agency about the statistical complexity, the cost to us.
Most importantly, the statistical complexity and the lack of a predicate requiring that we compare a drug to a surgical procedure for superiority. After years of discussion, and actually after enrolling hundreds of patients in the ATLAS trial, comparing UGN-102 to surgery, we finally were able to convince the agency that a single-arm open label trial would in fact support approval. We closed enrollment of ATLAS, continued to follow the patients because it's a very valuable data set, and opened the ENVISION trial. ATLAS is a trial that examines both patients with new and recurrent disease, ENVISION is focused on patients with recurrent disease.
In aggregate, we will have hundreds of patients treated with both new and recurrent disease, that we will then incorporate into our NDA submission in 2024, with a very robust data set, and hopefully, we will be able to obtain approval for the drug.
Yep. You bring up an important point with regard to ATLAS, where you did obviously make substantial progress in the enrollment for both the UGN-102 arm, as well as the surgical comparator arm. From a data perspective, you know, what does that provide you in terms of, like, a safety database? You know, even as you mentioned, that the statistical complexities make somewhat of an analysis challenging here.
Yeah, no, it's a great observation on your part, and quite honestly, we're very excited about the fact that we are going to be able to, at least descriptively, evaluate how surgery compares prospectively to UGN-102. We'll have a robust safety data set as well as efficacy data sets to evaluate. Although we will not be able to, you know, based on our original statistical analysis plan, directly compare the arms, we'll certainly have lots of data that I think will be helpful directionally in evaluating the results of the ENVISION trial.
Right. Even a descriptive statistics would be useful here.
I believe so, yes.
Yeah.
Yeah.
Maybe just with regard to, since the data is in the near future, how do you and the team think about, you know, what you'll disclose with the ENVISION and the sort of ATLAS update and the top line results? Secondly, just in terms of refining timelines, when can we potentially expect this update here?
Yeah. I think, and I think Liz has said this publicly on a number of occasions, we're going to update everyone about the ATLAS trial and also some initial data from the ENVISION trial this summer. We don't have a precise date, but there'll be plenty of notice about when that's going to happen. With respect to what's going to be released, the top line data will include, for the ATLAS trial, the primary endpoint, which is disease-free survival, as well as secondary endpoints, such as complete response rate and durability of that response for both arms, which will be very important in terms of, as you point out, descriptively understanding how the two therapies might compare. Simultaneously, we will also have the complete response rate, which is the primary endpoint for the ENVISION trial.
We'll have a big safety data set for ATLAS. We will only have complete response for ENVISION because we will need to follow those patients until we have at least 12-month follow-up on each individual. Again, I think the similarities to our phase II and the robustness of the ATLAS data set ought to directionally inform us about what to expect from ENVISION, and also, frankly, be reassuring with regard to the outcome of the program overall.
Just for our clarification, this is not 12-month data that you're presenting with ENVISION, it's just the initial complete response, right, at the three-month data?
Correct.
Yeah.
We do, we do not yet, and will not at that time this summer, have the follow-up data, but we, of course, will need that before the submission to the FDA.
Okay, great. As you thought of patient enrollment and sort of patient criteria, you did refine it to the recurrent population as you mentioned here. Is there anything in terms of trial execution or trial design relative to your phase II OPTIMA program, that suggests there could be incremental improvement on what you showed previously? How should we think about that potentially with your upcoming ENVISION data?
I think we have, perhaps, conservatively believed that most phase III programs experience some decrement in efficacy. We will not be overly disappointed if there is some movement away from the 65% complete response rate observed in the OPTIMA program. Just because this is a larger phase III trial, obviously conducted internationally, that might be expected. I don't think we're expecting it to be better, but we are expecting it to be very similar. Again, we are performing this study in patients that are very similar to our OPTIMA program with the same drug, a very familiar drug, the mechanism of action, which we understand, particularly in the context of this disease. We're you know, we're cautiously optimistic that we're going to see very similar results in the.
these programs as well.
Okay, great. You spoke to one more other point, which is just the longer term follow, 12-month follow-up, that'll be part of the study design. As part of your thinking down the road for a filing for UGN-102, what other sort of data points are needed beyond that follow-up? Could you maybe just elaborate on that and just how that figures in your filing strategy?
I think it's going to require a conversation with the agency, and then we are planning on having that conversation to determine what their level of comfort is with what amount of follow-up will be adequate for a filing. We certainly believe the 12-month follow-up on all patients will be very important for the ENVISION trial. Whether the agency requires or is interested in a greater per-percentage of patients having more follow-up is a matter of discussion, and we don't know the answer to that yet.
Okay, great. maybe, you know, continuing with sort of a forward-looking view, as you think about the target product profile of 102, maybe, both for you and/or for Jeff, can you maybe highlight or contrast, you know, what, you know, what are some of the features of 102 that you think are, you know, are different from, different from Jelmyto here? What, you know, down the road, in terms of a product profile, could help foster faster adoption in a non-pandemic environment for 102, commercially?
let me ask Jeff Bova to comment on that.
Sure. Just the sheer convenience, you see a smile on my face because of the convenience of 102 from a couple perspectives. One, physicians don't need fluoroscopy, they don't need a C-arm, so that means they don't need to actually see where the catheter is. With Jelmyto, you need to know where you are in the kidney, which is why a lot of that, we just talked, Paul, a lot of that business was in the hospital. Antegrade helps that for Jelmyto. With 102, I envision 90% of the administration being given in the clinic, therefore, I don't need formulary review. I also don't have to worry about mixing. We're more than likely, because we have stability, to go out with a mixed-only product.
If you remember with Jelmyto, Mark just alluded to this, community urologists don't like to mix, don't want to mix, they can't mix mitomycin and these chemotherapies. We're more than likely going to be able, because of our stability, ship them a mixed product in their clinic. They'll have a couple of days that they'll set it up. From my perspective, everything that we've tried hard to make sure we minimize the operational lift, it will be much more convenient with 102. The other thing about 102, we just completed a home installation study to show how convenient it can be given. It can be given by a nurse or an extender. Not only will it come into the...
patient will come into the clinic, where they're very comfortable, going, it will more than likely, after probably the first dose, be given by a nurse or extender that then frees up the urologist's time. From, I, assuming the data and everything looks good, this is a much different look from an adoption standpoint, just because of the sheer things that we don't have to worry about: formulary review, mixing, who's going to mix, mixing training, all those things that we overcame with Jelmyto, we don't have those challenges with 102.
Okay, great. You're obviously thinking, on the forward here, making a user experience, more convenient, easier, and avoiding some of the barriers that you've mentioned with Jelmyto here. Just in terms of, like, follow-up and product development, are there any things you would highlight that differ versus the clinical-grade product, I guess? Are they largely similar?
Do you want to comment on the similarities to Jelmyto?
Yeah. I'm sorry, the UGN as it's being used in the clinical study versus the tweaks you've been thinking about, for, to make it for, more easier for us.
Oh, I... Yeah, I think, I think what's being used, currently in these studies is what will be sold, and correct me if I'm wrong.
Yeah.
I mean, it, I think what, you know, what we're studying is what we're going to give people to use.
Okay, great. looking forward to that update coming up here. In terms of you've spoken Jeff, on the commercial considerations of making it easier, but you also have other drugs in the pipeline besides 102. Mark, at the beginning, you referenced a CTLA-4 that's in development. Can you maybe provide us an update on what's been going on there in your immuno-oncology efforts?
Sure. Our programs to date have been focused on low-grade disease, but high-grade disease, which is a smaller population of patients, is a very interesting subgroup of the bladder cancer population we're very interested in as well. This is an area that has received a lot of attention because, of course, this is the group of patients treated with BCG, and BCG is in short supply, so there's a rush to try to find alternatives for this group of individuals who alternatively would have their bladders removed if conservative measures are not successful.
Our preclinical data showed empirically that a combination of a TLR7 agonist and a anti-CTLA-4 antibody delivered intravesically in our gel platform produced a survival advantage in a murine model. We've moved that to phase I, and we are now in the final stages of dose escalation to find our monotherapy dose for the anti-CTLA-4 antibody we had licensed from Agenus, a company in Boston. We'll be prepared to move into combinations in the very near future. We'll probably have some data later this year about the monotherapy experience and probably could expect to talk about combinations, which could either be with our own TLR7 agonist or other agents, even considering potentially UGN-102 or others in probably in the coming year.
An exciting program and, really unique because as far as we're aware, there is great interest in, but relatively little activity in delivering antibodies directly to the urothelium. We are out in front on that opportunity. Conversation.
Okay, great. One of the historical challenges, of course, with CTLA-4 has been the immune response to it. Maybe can you give us a little bit more background on the asset that you licensed in from Agenus? What maybe makes it different from some of the known, you know, CTLA-4 assets that are out there?
This is, I think, probably actually, if administered systemically, not unlike other anti-CTLA-4s that with which everyone is familiar commercially. What is new about it is the way we're delivering it. It is being delivered in our RTGel platform. We've had conversations even with Jim Allison, the describer of and discoverer of anti-CTLA-4.
I think we've heard of, about him before.
Yes. You know, it is interesting to note that Jim Allison was, in fact, intrigued by our program because this would not invoke a typical mechanism as we understand the activity of anti-CTLA-4. Nonetheless, it is our intention to deliver it this way, particularly because it sidesteps the systemic side effects of this very effective antibody, which can be rather severe and difficult to manage. We think this is a very novel program, and we're looking forward to reporting our data.
Okay, great. We do have Don Kim in the audience, CFO, as well with us. Maybe a quick question for him since we're coming up on time, which is, maybe how do you and the team think about, I guess, you know, prioritizing capital allocation right now? You have, obviously, a major pipeline read up, coming up here, but also, maybe can you comment on, what your thoughts are on potential business development and/or partnering here?
Yeah, sure. Thank you for the question. Basically, you know, we are talking, I mean, every day, this is one of our top priorities, especially my job. We are also talking about the OpEx, you know, saving, and also we are looking at the Jelmyto sales at this point, and also our top price change every day, and we are thinking about all the equity, debt, and royalty, and also we have active ATM as well. You know, short answer, we don't know yet. We are really opportunistically looking at the prior, you know, trend and priority at this point. You know, we publicly also disclosed that our current cash, you know, run into the, you know, H1 of next year.
Before that, we are going to raise some form, and we are thinking the, you know, considering the best option for us right now.
Okay, great. On business development and partnering, for potential, let's say, commercial expansion into other geographies, any thoughts there?
Right now, no, that's not our top priority at this point. You know, it is limited resources. We just want to focus more on Jelmyto to stage and want to approve her. You know, we are always open to any opportunities.
Okay, great. Okay, we're coming up on time here. My thanks to UroGen for joining us today. We'll end it on that note.