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

Good morning, and welcome to the UroGen Pharma KOL webinar. [Operator Instructions] A question-and-answer session will follow the formal presentations. [Operator Instructions] As a reminder, this call is being recorded and a replay will be made available on the UroGen website following the conclusion of the event. I'd now like to turn the call over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead, Vincent.

Good morning, everyone. As Tara mentioned, my name is Vincent Perrone, Head of Investor Relations for UroGen Pharma. I'd like to welcome you to UroGen's key opinion leader webinar for investors and analysts. The topic for today's webinar will cover the unmet need and treatment landscape for non-muscle invasive bladder cancers, or NMIBC, with a focus on low-grade, intermediate-risk NMIBC. Next slide. Before we begin, let me remind you that during today's call, the company will be making forward-looking statements concerning future events, including, but not limited to, statements regarding our intentions, expectations and beliefs regarding our product and product candidates, our ongoing clinical trials and our business operations. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and are subject to assumptions, risks and uncertainties that could cause actual outcomes to differ materially from those contemplated in these forward-looking statements. In addition, any forward-looking statements represent the company's views only as of the date of this webcast and should not be relied upon as representing the company's views as of any subsequent date. A description of potential risks and uncertainties can be found on Slide 2 of the presentation and in our latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. Next slide. We have about an hour scheduled for today's webinar, and we'll be working our way through the following agenda, which outlines opening remarks from Liz Barrett, Chief Executive Officer of UroGen Pharma; Mark Schoenberg, Chief Medical Officer of UroGen Pharma will introduce Dr. Huang and Dr. Steinberg, who will each speak for approximately 10 to 12 minutes. Mark will conclude with an update on the UGN-102 Phase III ENVISION study before moderating a 20- to 30-minute Q&A session. At this time, I'd like to turn the call over to Liz. Liz?

Thank you, Vincent. Hello, everyone. Next slide, please. As you've heard, we're here to talk about UGN-102 and, importantly, the landscape of non-muscle invasive bladder cancer. As many of you know, when we've shared before, this is really in response to high unmet need in the area of urothelial cancers. Before -- prior to UroGen, the invasive and radical surgery is the standard of care currently in urothelial cancers, making it challenging for physicians to treat. Why? Because of the anatomical barriers associated and the inability for medicines to dwell long enough in a cavity to actually have a meaningful impact. So what happens is these patients go through repetitive risky surgeries, they oftentimes lose their kidney or other organs, and there's an increased risk of morbidity in elderly patients. Next slide, please. Because of this high unmet need, a group of chemists in Israel actually developed the RTGel. RTGel is a proprietary reverse thermal hydrogel technology uniquely designed to allow for local delivery of medicines and in direct response to physicians calling out this unmet need in the area. So as we talked about before, it increases dwell time, allows for drugs to be longer in the cavity and hopefully improving the therapeutic effect. Next slide. As we think about UGN-102, let me remind everybody, it's an investigational nonsurgical treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer. It utilizes the RTGel technology that's proprietary to UroGen, and it delivers mitomycin very similar to our current Jelmyto that is on the market. And as I mentioned before, it exists as a liquid when it's chilled and as it hits the warm temperature of the body, turns to a gel and allows for medicine to be delivered over a several hour time period. It's intended to reduce the recurrence and patient burden associated with TURBT, and you're going to hear a lot about that today, so I won't go into that. If approved, UGN-102 would be the only primary intravesical chemotherapeutic -- chemoablative treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer. And importantly, it's 96% of urologists that we -- in our survey said that they would use UGN-102 within 2 years of approval. Next slide. As I've mentioned before, there are a lot of similarities between our current Jelmyto and UGN-102 in the sense of if you -- Mark and I'm sure doctors can also comment on this -- the disease in the upper tract urothelial cancer and as well as bladder cancer, really similar cancer. And what we've seen in our results so far, clinical results, that in the Phase III OLYMPUS study for Jelmyto, we had a 58% complete response rate and about an 82% duration of response by Kaplan-Meier analysis. And similarly, with UGN-102 in our Phase IIb OPTIMA study, a 65% complete response rate and a 72.5% duration of response. What this tells us is that they work similarly to each other. And as I mentioned, the molecular profiling shows that these 2 diseases are very similar, giving us a nice proof of concept using Jelmyto and the Phase II study for UGN-102, getting us high confidence in the results of the upcoming Phase III pivotal study. Next slide. I do think it's important, though, to notice the similarities but also the distinct differences and, in this case, hopefully, advantages of UGN-102 over Jelmyto. It's really the same method of delivery, as I mentioned. It's mitomycin and RTGel. Although they are different drugs, they're different because the ratio of the medicines is different and the volume is different. You need a much bigger volume for the bladder than you do the upper tract. Low is, as I mentioned, similar diseases, similar results and synergies from a commercial standpoint because about 95% prescriber base is the same for Jelmyto and UGN-102. But the distinct differences are that the UGN-102 is a much simpler medicine to give to patients. It's a simpler administration because you're not manipulating the upper tract. You don't have to get to the upper tract so you don't need fluoroscopy, you don't need to -- there's certain equipment -- other equipment that you don't need. The installation is a routine, a simple procedure that can be done in the clinic and be done by doctor or it could be done by a nurse or an extender. And importantly, as we've talked about before, the market for bladder cancer is obviously much bigger than the market for upper tract. Next slide. And this gives you an example of -- it's a $3 billion-plus market if you had all patients in this low-grade, intermediate-risk non-muscle invasive bladder cancer. About 80,000 patients annually in the U.S. alone, about 60,000 of those patients are what we call recurrent patients and the current treatment today is a TURBT, or transurethral resection of the bladder tumor, which you're going to hear a lot about today. Again, the characterization of the intermediate-risk patient is characterized by multiple tumors, large tumors greater than 3 centimeters are the actual recurrence and the fact that these patients continue to recur. So with that introduction, I'm going to turn it over to Mark Schoenberg to introduce our physician panel today. So Mark?

Liz, thank you very much, and good morning, everybody. It's a real pleasure to have 2 esteemed colleagues join us this morning to talk about the treatment of urothelial carcinoma and specifically about the treatment of low-grade, intermediate-risk disease. Dr. William Huang is the Vice Chair and Co-Director of Robotics in the Department of Urology at NYU Langone Medical Center; and Dr. Gary Steinberg is the Director of the Bladder Cancer Program at NYU. So we are lucky to have them. They are experts in the management of this disease, have experience with UroGen's products, and we look forward to their presentations and the Q&A. So with that, let me go to the next slide, please. These are the faculty disclosures, which are included in the slide deck and let me then turn the podium over to Dr. Huang, who will be the first to present. Bill, the floor is yours.

Good morning. Thank you. So I'm going to give a brief background on bladder cancer basics and then also describe the unmet needs for these patients with bladder cancer. Hopefully, you can hear me. Next slide. So as you previously heard, the urinary tract is really divided into 2 locations, the upper tract which is the kidneys and the ureters as well as the lower tract which is the bladder itself. As many of you may know, a similar product, Jelmyto, is used to treat the upper tract and UGN-102 is being used to treat the lower urinary tract, which is the bladder. The entire urinary tract is covered with a lining, which is similar to the skin on the outside of our body, and it's this lining that develops bladder tumors or urothelial tumors. Next slide. So some key facts to recognize is that bladder cancer is extremely common, unlike its counterpart in the upper tract, with over 80,000 cases diagnosed per year, and this results in about 17,000 deaths per year from bladder cancer, making it the second most common urologic malignancy. It happens more commonly in men with a 4:1 ratio. And it essentially results in over 700,000 people in the United States living with bladder cancer today. Next slide. So how we determine the management of bladder cancer or all urothelial cancers really is dependent on the grade and the stage. So you can think of grade as how aggressive this particular tumor is and there are 2 grades that we give to urothelial cancers, which include low grade versus high grade. Low-grade tumors are tumors that appear relatively normal or look similar to the way normal bladder cells look, whereas high-grade tumors are abnormal appearing and have a propensity to invade and potentially spread. Next slide. So if the tumor does demonstrate any invasion, then this changes the stage of the bladder cancer. And so stages are really broken down into 2 parts. You have non-muscle invasive bladder cancer, which is a bladder tumor that's only on the surface or invades only into the first or second -- the first layer of the bladder wall. You can hit the next slide. And then you have muscle invasive bladder cancer, which results in invasion even deeper into the bladder wall into the muscle, and that is managed completely differently than the way that we would manage low-grade or non-muscle invasive bladder cancers. So again, the management of bladder cancer is highly dependent on the grade and stage of the tumor. Next slide. So as you may have heard, the way that we manage bladder tumors initially, irrespective of whether it's low grade or high grade, is through transurethral resection. A transurethral resection is the insertion of a metal tube or rod into the bladder through the urethra, and then that instrument is used to resect the tumor, and if we could show the video of this. So as you can imagine, since this is a metal rod that's inserted into the bladder, this needs to be done under anesthesia, and there is a hot electrified loop at the end of the instrument and it's used to shave the bladder tumor down. Now since this procedure is the hallmark of treatment for bladder cancer, this results in patients who are frequently older and sicker having to go to the operating room to undergo this procedure. Not surprisingly, this procedure is associated with the risk of complications, including pain and urinary symptoms from having the instrument inserted. In addition, there's a risk of bleeding. As you can imagine, the bladder is well vascularized and many of these patients are older and are on blood thinners, increasing their risk of having bleeding complications. In addition, there's a risk of infection as well as injury during the actual procedure itself. And we can show you an example of how easily an injury can happen to the bladder during a transurethral resection. We could show the next video. So this is a bladder tumor that's very close to a nerve in the pelvis and you can see that, that easily can result in a perforation through and through of the bladder during this routine procedure. One final thing to take into account as well is that these patients require lifelong surveillance and frequently require treatment over and over again. And that's because up to 60% of patients will have a recurrence within a year and up to 80% of patients will have recurrences after 5 years of their initial treatment. So this is a procedure that frequently has to be done in patients once they've been diagnosed with bladder cancer. Next slide. Now there is a particular cohort of patient or a group of patients that we're going to focus on because these patients have a propensity to recur frequently within a year or they have larger tumors over 3 centimeters, which are low grade. So these are patients that are primarily diagnosed with frequent recurrences and, therefore, is exposing them to the need to have recurrent treatments throughout their lifetime. And so the unmet needs are providing them with additional treatment options that we can do besides the repeated surgeries as well as reducing the chance that they're going to recur, which happens frequently. And from here -- next slide. I'm going to conclude with the fact that bladder cancer is a common cancer affecting over 700,000 Americans. Most bladder cancers are actually low grade and non-muscle invasive, which is a good thing. However, these patients are at lifelong risk of recurrence and repetitive treatments. The standard treatment that we have, even 50 years after initially undergoing treatment for these and even longer, is TURBT. So there's a significant unmet need for these patients with non-muscle invasive bladder cancer. And I'm going to turn it over to Dr. Steinberg.

Thank you, Bill. Can everyone hear me?

Yes, we can.

Thank you. So I'm going to talk a little bit about treating intermediate-risk non-muscle invasive bladder cancer. Next slide, please. So for patients with non-muscle invasive bladder cancer, the standard of care is to try to completely remove the tumor with the operation as Dr. Huang just outlined. Adjuvant therapy for all patients, well, that is a bit debatable, especially now that we have a BCG shortage. So we clearly have moved away from using intravesical BCG, which is immunotherapy in the bladder for patients with intermediate risk disease. As also Dr. Huang outlined, many of these patients are elderly. They require family members, children, relatives to drive them to the office for intravesical therapy. And so it is reasonable in these patients to not use any adjuvant therapy and just treat them with repetitive transurethral resections of bladder tumors, which, as Dr. Huang outlined, does have its risks and complications. There is a thought that you potentially can give 1 dose of chemotherapy into the bladder within 24 hours after a TURBT. It's thought to eliminate implantation of tumor cells. We'll discuss this a little bit later. I personally think that tumor cells don't implant that way. That's not the way biology of cancer works. There have been randomized studies demonstrating an 11.7% decrease in the recurrence rate using a single dose of chemotherapy after TURBT, whether it's mitomycin C, doxorubicin, epirubicin or gemcitabine. However, it really only shows a benefit in patients who have low-risk disease. Those are patients with primary solitary tumors that are low grade, typically small. These are what we call low risk, and low risk meaning low risk for recurrence and progression. Intermediate risk, intermediate risk for recurrence and progression. And certainly, if you perforated the bladder or you thinned out the bladder too much and some of these chemotherapy drugs are given after the TURBT, they can infiltrate the -- through all the layers of the bladder and can cause some significant lower urinary tract symptoms that can last, if not 6, 12 months, even longer. Next slide. We also know that the TURBT is expensive. [indiscernible] construction of Markov model to determine the cumulative cost of care over a 5-year period of the surveillance of patients with non-muscle invasive bladder cancer. This is not talking about TURBT and intravesical therapy. This is just a surveillance. And so the Markov model estimates during a 5-year, cost for low, intermediate and high-risk non-muscle invasive bladder cancer. For the intermediate risk, we can spend close to $150,000 just for surveillance with cystoscopies and cytologists and so forth. Next slide. Well, why do we use intravesical therapy. That's a medication we put in the bladder. Well, the rationale is it may prevent tumor implantation, which I don't believe in, because I don't think that's how biology works. Cancer cells don't just float around and then all of a sudden attach to certain parts of the bladder. There has to be multiple molecular changes for that to happen. We do know that it has a cytotoxic effect against residual cells that we may not see. Potentially, it can cause immune cell death, turning on the adaptive -- the innate and the adaptive immune system. However, as we know, there is T cell exhaustion when you turn on the immune system too much. We know that by giving medication in the bladder, it's limited toxicity. However, we also know that there's limited efficacy because how much of the drug actually attaches to the cell wall, how much it actually is absorbed and becomes effective, we believe, is limited due to multiple chemical factors and physiologic factors, and that it's been estimated that when we use mitomycin C alone in solution that we may only affect or have efficacy of 1% to 2% of the drug that we've instilled and to the urothelium. We want to give the intravesical therapy to decrease recurrence and progression. Again, intermediate risk as in intermediate risk of recurrence and progression. Progression is maybe 2% to 5% to 10%. Recurrence, however, can be 50% to 70%, if not higher, if not treated. And then also chemoablation, which is a very important topic. It's actually going around -- there's a conversation on Twitter right now in the bladder cancer world about -- for patients who have had a recent myocardial infarction and they cannot undergo anesthesia to potentially put some intravesical chemotherapy in their bladder for chemoablation, again, without data, without randomized prospective trials, but it certainly is a concept that is readily available to urologists. As an adjuvant, 15% short-term decrease the recurrence rate. No change in progression, multiple studies over 6,500 patients, no drug better than others. There was a recent trial looking at heated mitomycin C versus standard intravesical mitomycin C in intermediate risk patients used in an adjuvant setting. And we saw very high recurrence rates in both groups. There was no benefit from the heated mitomycin C, but more importantly, it shows us the natural history is that when you use your standard intravesical chemotherapy, there is a very high likelihood of recurrence. Next slide. And again, just to reiterate, and Dr. Huang spoke about this, but the intermediate-risk patients are patients who have recurrences within 1 year of low-grade noninvasive tumors. They have solitary low-grade tumors greater than 3 centimeters in size; multifocal, low-grade tumors; they have high-grade TA tumors that are less than 3 centimeters in size. First-time event, any high-grade recurrence would make it a high-risk tumor. And then low-grade T1, which is a tumor that superficially invades into the submucosa of the bladder, but it's still considered low grade. In the old days, we used to call those T1 grade 2s. I actually think that low-grade T1 doesn't exist very commonly. Next slide. The intermediate-risk patients are not straightforward to identify or treat. It's a heterogeneous population. There's a lack of independent studies comparing therapies. I mean there's a lot of therapies that urologists use without any randomized prospective data. The uncertainty remains about the categorization of the patients and the current clinical guidelines vary. There's certainly what the guidelines say and what happens in the real world. And in the real world, many of these patients do not receive any significant adjuvant intravesical therapy. Many times are just treated in repeated trips to the operating room or tumors are fulgurated in the clinic or some are just followed conservatively, especially the elderly patients, and we wait until the tumors get bigger. Next slide. Well, the primary chemoablation of low-grade, intermediate-risk NMIBC with UGN-102, the OPTIMA II trial. These patients were treated with 6 weeks of UGN-102 once a week for 6 weeks. They were followed at 3 months. We looked at the complete response rate at 3 months and then every 3 months after that, they had cystoscopies and cytologies. The secondary endpoint, a 12-month durability and safety, total -- initially enrolled were 63 patients; 38 men, 25 women. Again, bladder cancer is 4x more common in men than women. So it's good to see so many women in this trial. The complete response rate, this is -- again, this is not adjuvant therapy. These are patients with tumors treated with chemotherapy as a chemoablation to avoid or eliminate the need for transurethral resection of bladder tumor. We've got a 65% complete response rate. Of those of a complete response, we see that the durability of the response is quite favorable. There are mild to moderate adverse events were common with dysuria and hematuria, which we see with any intravesical therapy trial. Next slide. And then this slide, it's a little difficult to see, but again, this is just showing the durability so that of the patients with a complete response when you follow them at 9 months or 6 months after their complete response, you still see 73% are disease-free. And 12 months or 9 months after the complete response, 61% are still disease-free. And then there is no reason why if you've got a complete response and patients recur that you can't re-treat these patients. And do you need to re-treat them with 6 weeks? Or can you re-treat them with 1 or 2 doses? That's something that I suspect urologists will figure out fairly quickly. But I think that the urologists will really gravitate to this therapy because it truly helps save patient's time, physician time and so forth. Next slide. So in conclusions, there was a recent study looking at a pancystoscopy, which is blue light cystoscopy, I'm sure everyone's heard of, versus white light cystoscopy. And the very sobering finding of this trial was that at 3 years, there was no difference in recurrence rate in the blue light versus the white light. And more importantly, what it shows us is that the natural history of the disease is that it's a field change defect of the urothelium and that you have recurrences and that surgery alone is not going to change that. So what is clearly imperative is that we get better intravesical therapies. We get better intravesical therapies, that's the only way we're going to alter the natural history of this disease. And again, that was a big conversation going on around Twitter on the bladder cancer world of late. There is financial toxicity. Every time you bring a patient to the OR, the family has got to take time off, the patient has got to take time off. They've got catheters put in the hospital, they've got to recover. And so there's a tremendous amount of morbidity and financial toxicity of TURBT, especially in the elderly. We want to find a medication that's easy to use. There's no question that UroGen 102 -- UGN-102 is something that every urologist is very comfortable doing in their office and do many intravesical treatments. And then the other thing is that for the urologists and our health care system is we're changing our health care system and physicians are being paid by relative value units. Every time they've got to take half of a day to go to the OR and there's all the turnover, the RVUs for a TURBT, quite honestly, are not that high. It is a definitely loss for the physician's practice if he's got to bring elderly patients to the operating room. And clearly, it would be highly beneficial for the practice if they were able to use intravesical chemoablation in the office. And so there, I think I must sum up. I think I've given people plenty of things to discuss, and we'll go from there.

Gary, thank you very much. And I want to thank both Bill and Gary for their summaries and very timely remarks, really appreciate it. Before we go to the Q&A, just 2 brief comments I want to make targeting back to Liz's initial remarks. As she mentioned, and on the basis of the data that Gary presented, UroGen embarked on a Phase III program initially in a randomized trial of UGN-102 against transurethral section. And after a series of extended conversations with FDA, we moved that program into what is currently a Phase III program that is ongoing, enrolling now and will be enrolled by the end of the year, which is the ENVISION program, a single-arm open-label trial, essentially exactly like the trial that Gary described, the OPTIMA Phase II trial. And again, that is in contrast to what was the original ATLAS trial. The data from the ATLAS trial actually are being accumulated and it is not fully enrolled, so it's a smaller population than was originally planned. Again, that's the randomized trial against TURBT. Safety data as well as some efficacy data will be available next year, and we will share that when appropriate. Next slide, please. And this is just the study design of the Phase III ENVISION trial, currently enrolling internationally 220 patients. And as Gary described, weekly dosing through a period of 6 weeks with UGN-102 for patients with intermediate-risk, low-grade non-muscle invasive disease, all of whom will have had prior experience. So all of these patients are recurrent patients. We expect full enrollment this year, follow patients next year, plan submission for approval in '24. So very exciting, and we're very enthusiastic, as Liz mentioned, largely because this trial is so similar to the Phase II results of which you just heard about. So with that, let me stop and turn this over to the LifeSci team for Q&A. Thank you.

Great. Thank you, Mark. At this time, we'll be conducting a question-and-answer session with our speakers. So our first question comes from Chris Howerton from Jefferies.

Really appreciate hosting this event. The question...

Chris, it sounds like you're breaking up a bit.

[Technical Difficulty] the physicians would be -- the lack of randomized data in this -- can you hear me at all?

You're fading in and out, Chris.

Got it. Well, question is how do you anticipate and -- treatment setting do you anticipate 102 being used the most? [Technical Difficulty]

Tara, I think I heard enough of Chris, so I'm going to re-ask it for him. And maybe Bill and then Gary, you could respond in turn giving your answers to the question. But first, I think part of Chris' question is, given the fact that the Phase III ENVISION trial is a single-arm trial, do you believe that the lack of randomized data against the standard of care control will significantly impact adoption and the perception by urologists who were the users of the medication for appropriately selected patients? So Bill and then Gary, could you respond to that?

I personally don't believe that the lack of randomized data would significantly alter urologists' or a physicians' decision to use this drug. I think that's partially based on the fact that the alternative would be transurethral resection, which urologists perform. And in many cases, we are trying our best to avoid having to do that. In addition, I think that urologists are very comfortable using agents that are done intravesically and didn't necessarily have randomized data in the past historically to compare it to prior to using a drug such as this.

Gary, what do you think?

I think the patient population is huge, and this is a very common problem for every urologist. And I think that there is plenty of historical data. I think that every urologist knows what the recurrence rate is of these patients. And if they can avoid 50% of their TURBTs, they'll be thrilled. And I think that the urologists will very quickly adapt. They will be able to predict which patients will benefit most from this. And I suspect that -- again, we talk about a complete response. If you get a patient and you give them UGN-102, and you don't get a complete response but you get 90% response and that the rest you can just fulgurate in the clinic, that's a big win. So I think that urologists are going to gravitate to this very, very quickly. And I don't think that the lack of randomized controlled trial will be a problem. Urologists, unfortunately, are used to doing a lot of nonrandomized trials and publishing a rather nonrandomized data and readily adopting information.

Thank you. That certainly is an accurate characterization of our current state of practice. I think Chris wanted to know who the right patient is for this and how you would characterize that individual. I think we've talked a little bit about what the guidelines are for or at least the current characterization to intermediate risk is. But who do you think this is going to get used? And Gary, do you want to go first and then Bill?

Yes. I think any elderly patient with low-grade papillary appearing tumors, whether even for a primary event, even for somebody "low risk," I suspect that to avoid a trip to the operating room, it will be utilized. So I think that this is a huge number of patients with low-grade non-muscle invasive bladder cancer, which makes up at least half, if not more, of the newly diagnosed bladder cancer patients in the United States.

Bill, any thoughts?

Yes, I definitely agree. I think this is really a great treatment option for those patients who are older, who have a history of having repeated tumors and those are low-grade tumors that we often see in our clinic. And as I mentioned in the basics, up to 2/3 of patients will have recurrences. So this is a very, very common patient population that we're all used to dealing.

Thanks very much. Let me turn it back to you, Tara.

Chris, just had a follow-up question. He was wondering what setting is more likely to use given surgeons want to perform surgeries.

Bill, why don't you go, and then Gary?

Well, although surgeons may want to perform surgeries, this is not a surgery that many of us want to willingly perform in this patient population. I didn't really get into specifics about this patient population. But as I mentioned, they're elderly. They have a lot of medical conditions and taking them to the operating room is hard, both on the surgeon as well as on the patients. So this is definitely not something that surgeons are enthusiastic about spending their time as well as patients' time doing.

Gary?

Yes. I think that that's an excellent question. And as you know, a lot of the reasons we do things in American medicine is by following the money. But there's no question with the health care changes that we have where the vast majority of physicians are now employed and not in their own private practice, the economics of taking these patients to the operating room is actually counterproductive and the urologist is more efficient economically by treating these patients in the office. And I think that that's only going to become more true and -- as the health care system continues to evolve in the direction it's evolving. So I think that there's going to be a tremendous incentive for urologists to treat these patients in the office with UGN-102.

Our next question comes from Matt Kaplan from Ladenburg.

Thanks for hosting this KOL call. Just wanted to dig in a little bit more to the ongoing Phase III study of the ENVISION. I guess given the strong results you saw with the Phase II study, 65% complete response rate and strong durability, I guess for the 2 doctors, what would you be looking for in the larger Phase III that will get you excited in terms of complete response rate and durability for the ENVISION study when those results are announced?

I can go first. I think that if we replicate the results from Phase II, I think that's acceptable. I think that urologists will use this. And so even in the patients that recur that have a, for example, a 6-month duration of response, they may re-treat. They may not re-treat with another 6 weeks. They may re-treat with 1 to 2 weeks, 3 weeks and so forth. But I think that maybe some additional granularity in terms of the ENVISION trial in terms of when patients recur, what do they recur with? Do they recur with again a tiny little tumor? It can then be fulgurated. So I think that additional granular detail will be helpful and help define how this is used. But I think that -- I suspect that the ENVISION trial will reinforce the benefits that we're seeing in the Phase II trial.

Bill?

Yes. I completely agree with Gary. I think having this Phase III trial will just reinforce 2 things. One is the complete response rate as well as the durability, which I think are very important. I think another thing would be to demonstrate that it is well tolerated in a bigger population than the one that was in the Phase IIb trial.

Okay. That's very helpful. And then 1 follow-up question, I guess, for Dr. Steinberg. You elaborated on the cost of TURBT and surveillance. How do you think UGN-102 could impact the cost of managing the patient with this intermediate-risk, low-grade non-muscle– invasive bladder cancer?

Yes. Well, so the cost is not just for the patient but also for the family members that have to drive the patient to the operating room and then pick them up, so they have to take a day off of work and then they -- the patient comes home, they may or may not have a catheter. So the family members keeping track of the patient, making sure they're doing all right. So it's -- again, when we look at the larger health care costs and the morbidity of surgery, it is significant and it is a significant quality of life issue, not just for the patient, but also for their family members and caregivers. So patient comes in, even 80-year-old patient can drive themselves to the office and get their drug and go home. So I think that when you look at the grander scheme of things and -- and then we also -- there is morbidity from surgery. I mean -- any time there's a complication, urinary tract infection, urinary retention, blood in the urine and so forth, all of those things add up and make it into a very expensive, even though it's a relatively, what we call, a minor operation, but it's only minor when it occurs on somebody else, not when it happens on you or a family member. So anyway.

Our next question comes from Mitchell Kapoor from H.C. Wainwright.