Urogen Pharma Ltd

NASDAQ:URGN

Earnings Call Transcript 2023-Q1

[Operator]

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Q1 2023 Earnings Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone. Head Investor Relations. You may begin.

[Vincent Perrone, Senior Director, IR]

Thank you, operator. Good morning, everyone and welcome to UroGen Pharma's First Quarter 2023 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31, 2023. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; Jeff Bova, Chief Commercial Officer; and Don Kim, Chief Financial Officer.

During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO, anticipated seasonality for JELMYTO in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UroGen's products and product candidates to transform the treatment paradigm of urothelial and specialty cancers, market opportunities, potential future commercialization activities for UGN-102, if approved, data presentations, regulatory filings, future R&D development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet and 2023 financial guidance among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and 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.

I will now turn the call over to Liz. Liz?

[Elizabeth Barrett, President, CEO & Director]

Thank you, Vincent, and thank you to everyone joining us today. UroGen remains focused on developing novel therapies for urothelial and specialty cancers with the goal of fundamentally transforming the treatment paradigm for what we believe is a largely underserved patient population. With the launch of JELMYTO, we took an important first step in bringing to market an innovative nonsurgical therapy designed to improve the standard of care for treating low-grade upper tract urothelial cancer.

In achieving this goal, we have demonstrated the viability of intravascular delivery of chemotherapy and our proprietary RTGel to treat urinary cancer, setting the stage for our lead development program, UGN-102, which aims to address a major unmet need in low-grade intermediate risk non-muscle invasive bladder cancer, an indication impacting approximately 80,000 patients in the United States each year.

Turning to the quarter. I'm pleased to announce that first quarter JELMYTO net revenues were $17.2 million, our second best quarter ever since launch and a 27% increase from the same quarter 1 year prior. While continued growth in JELMYTO adoption is encouraging, we are further assured to see our guidance model consistent with actual results, indicating that the seasonality we've previously observed may be reliably predictable.

As the utility and benefits of JELMYTO are increasingly recognized in the rural world, it has also come to be acknowledged by the urology community as we recently saw at the 2023 American Urology Association Meeting in April.

Mark and Jeff will provide highlights from the conference. But at a high level, 2 additional studies reinforcing the utility and efficacy of JELMYTO were presented further strengthening the growing body of real-world outcomes data supporting its broad use.

Meanwhile, as we look ahead, the focus of our development strategy is very much on UGN-102 and at several near-term catalysts. Specifically, we remain on track to provide top line data from our Phase III studies of UGN-102 this summer. For ENVISION, we anticipate providing the primary endpoint of complete response rate of approximately 240 patients who completed the study. While for ATLAS, the predecessor to ENVISION, we will provide complete response, durability and safety data from approximately 280 patients that completed the study.

Assuming positive results, the ENVISION trial will form the basis of our FDA submission once durability can be appropriately measured. In anticipation of prospective favorable results, we expect to submit an NDA with the FDA in 2024. The goal would be to target priority review, which if granted, may potentially result in approval at the end of 2024 or early 2025. Our optimism in the potential outcome of ENVISION stems from a similarity to the Phase II OPTIMA II trial of UGN-102 which demonstrated a 65% complete response rate and duration of response at 12 months of 72.5% using Kaplan-Meier analysis.

We believe UGN-102 can be a transformational product and represent a significant opportunity to address a much larger patient population. Unlike JELMYTO, administration is much simpler without the need fluoroscopy. Therefore, if approved, we anticipate UGN-102 will be a significant driver of future growth as it will be the only primary nonsurgical therapy addressing the nearly 80,000 new patients in the U.S. alone, who will undergo repetitive endoscopic resection and a burden with the risk of surgery and anesthesia as the only recourse for disease control.

Before turning the call over to my colleagues, I would like to quickly address our balance sheet. We continue to emphasize rigorous fiscal prudence and prioritize our cash spend on advancing our core value drivers: JELMYTO and UGN-102 development. Given what we believe is a significant market potential for UGN-102, we are optimistic that we can take advantage of a number of potential viable opportunities to further strengthen our balance sheet when appropriate.

With that, I'll pass the call over to Mark. Mark?

[Mark Schoenberg, Chief Medical Officer]

Thank you, Liz, and hello, everyone. I'd like to begin by commenting on 2 recent JELMYTO real-world outcomes studies which were accepted for podium presentations at the 2023 AUA Meeting held in Chicago at the end of April. The first of these studies was conducted by Dr. Joseph Jacob and colleagues and highlighted results from a sub-analysis of the first and largest post commercial utilization review of JELMYTO in treating ureteral tumors. In this analysis, 47 patients had UTUC tumors involving the ureter.

With 12 cases of ureteral tumor only in 35 cases of ureteral plus renal pelvic tumors. Data from this study demonstrated no difference in JELMYTO outcomes at first endoscopic evaluation based on tumor location. Adding to the growing body of real-world evidence supporting broad use of JELMYTO in treating low-grade UTUC patients with multifocal disease. In addition to similar efficacy and safety results at first endoscopic evaluation, there was also no difference in recurrence rate or progression based on tumor location.

14 patients with ureteral tumor had significant ureteral stenosis at first post-treatment evaluation. However, only 5.4% of patients developed new clinically significant stenosis when excluding patients with preexisting hydronephrosis, which is the buildup of excess fluid in the kidney due to a backup of urine. The second study was conducted by Dr. Craig Labbate and colleagues. And highlighted results of a sub analysis from the same post-commercialization review of JELMYTO.

The study aims to evaluate efficacy and safety of JELMYTO when administered following complete endoscopic resection. Results from this study were also published in the May issue of the Journal of Urology.

In the publication, the authors noted that UTUC patients in this retrospective study who received JELMYTO following complete endoscopic ablation achieved a 69% complete response rate in first endoscopic evaluation. Whereas in the OLYMPUS study, patients achieved a 58% complete response rate at first endoscopic evaluation.

The rate of ureteral stenosis, for those in this study who underwent complete endoscopic ablation followed by JELMYTO treatment was 23% compared to 44% observed in the OLYMPUS study. The authors also note that UTUC disease recurrence is often detected at the first ureteroscopic evaluation after endoscopic ablation only. Early failure is a drawback for endoscopic ablation, which occurs in 40% to 50% of UTUC patients by 6 months. It's noted in the study that this may be due to incomplete resection or ablation of the primary tumor for which post ablation therapy is intended to treat.

We are pleased to see the growing body of real-world outcome data, providing compelling evidence supporting the use of JELMYTO in a diverse low-grade UTUC population. The acceptance for presentation of these studies at the AUA underscores the attention and recognition that these important data warrant. To further explore the full potential of JELMYTO for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT registry to capture data in a large-scale, standardized manner to report further on patient outcomes following JELMYTO treatment, including longitudinal follow-up.

I'd like to turn now to UGN-102, which we view as a potentially transformative therapeutic advance that I believe will be welcomed by my colleagues and patients alike. As Liz noted, we are excited to report data from the ENVISION and ATLAS clinical trials by the end of this summer. Our optimism about potential outcomes from both trials stems from their similarity to the Phase II OPTIMA II trial of UGN-102 which demonstrated a 65% complete response rate and duration of response of 12 months is 72.5% using a Kaplan-Meier analysis.

UGN-102 also has key similarities with JELMYTO. Both products utilized mitomycin allow for local delivery and sustained exposure to mitomycin for up to 6 hours.

And importantly, both low-grade NMIBC and low-grade UTUC share many biological and clinical similarities, which leads to common clinical features, including the responsiveness to chemotherapy. UGN-102, however, has several unique advantages over JELMYTO, which we believe will have a direct impact on its use. It does not require special equipment for procedures and is designed to be instilled into the bladder via urethral catheter in an outpatient setting, a common and routine procedure in most urology practices. This advantage will be critical as low-grade intermediate risk NMIBC is 8 to 10x more common and a condition that is routinely managed by 80% to 90% of urologists.

Inferring a significantly larger addressable patient population. Meanwhile, our Phase I trial with UGN-301, our in-licensed anti-CTLA-4 antibody for intravesical administration using RTGel technology continues to enroll. UGN-301 is in development for use in combination with other immunomodulators, including UGN-201, our proprietary TLR7 agonist and other potential chemotherapy and any other therapies to treat high-grade NMIBC.

This study is aimed at identifying the suitable dose for a subsequent Phase II trial. The first arm of this study evaluating dose ranges of UGN-301, as monotherapy is expected to be completed later this year. Results from this arm will inform the appropriate dose of UGN-301, for our first combination arm, which could potentially begin before the end of the year.

We view UGN-301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade NMIBC.

And with that, I'll turn the call over to Jeff for a commercial update. Jeff?

[Jeffrey Bova, Chief Commercial Officer]

Thanks, Mark. I'm pleased to see momentum in patient uptake activated sites and repeat prescribers from the end of last year carry into 2023 as Q1 represented our second strongest quarter for JELMYTO since launch. Adoption metrics in the first quarter continue to demonstrate encouraging trends in the new and repeat accounts. Activated sites on May 1, 2023, were 1,009 compared to 983 on March 1, 2023.

And repeat accounts were 235 compared to 214 for the same period. Reimbursement remains at approximately 99% across all coverage types. During the first quarter, we held our national sales meeting in San Diego, and I'd like to take a moment to share several key takeaways.

First, we recognize our top territory performers who have demonstrated sustainable growth in their accounts. They have shown that the opportunity for meaningful adoption in low-grade UTUC exists once physicians embrace JELMYTO. We've previously discussed our revised sales strategy designed to emulate the success observed in overperforming territories, which I'm pleased to say is improving penetration in developing territories.

At the meeting, we also rolled out enhanced messaging and sales resources from the growing body of real-world evidence data that has demonstrated the viability of JELMYTO across various practice patterns. We expect these new resources to improve our team's ability to effectively engage with new and existing accounts in the field to further drive appropriate adoption and patient penetration.

UroGen again, had a major presence at this year's AUA Meeting. Building on Mark and Liz's comments, we are very pleased to see specific mention of JELMYTO in the AUA and SUO first-ever low-grade UTUC treatment guidelines. The guideline states clearly that tumor ablation should be the initial management option for patients with low-risk UTUC for which JELMYTO can be a treatment option as a part of a kidney-sparing approach to disease management. With the use of JELMYTO in a multimodal regimen, patients with UTUC can achieve a durable complete response.

This is an important advancement in the treatment of UTUC. And we are proud to offer a treatment that is backed up by the latest AUA guidelines. We view the guideline as an important milestone for low-grade UTUC patients and broad recognition by AUA and SUO of the positive impact, new and innovative therapies such as JELMYTO can have in treating low-grade tumors. Our booth featured demonstrations on how our innovative RTGel technology is advancing care in uro-oncology and allowed the team to meet with physicians.

It also included a product theater featuring KOLs Jennifer Linehan and Sandip Prasad, which focused on the JELMYTO data including recently published real-world outcomes data and actual patient case studies.

Overall, we are very pleased to see acknowledgment of our clinical progress and real-world impact filtering through to clinician communities and society, and we look forward to continuing to work with the AUA and SUO as we further develop and expand JELMYTO and prospectively introduce UGN-102.

With that, I'll turn the call over to Don to discuss our financials. Don?

[Dong Kim, CFO]

Thank you, Jeff, and thank you to everyone for joining today's call. I'm pleased to be with you today to review our financial results for the first quarter ended March 31, 2023. For the first quarter of 2023, we reported JELMYTO net product revenues of $17.2 million, in line with consensus estimates and an increase of 27% compared to $13.6 million in the same period last year.

For the first quarter of 2023, research and development expenses were $12.5 million as compared to $12.7 million for the same period in 2022. The decrease is primarily due to lower expenses related to the ENVISION trial, manufacturing and clinical compensation offset by higher R&D expense related to the Phase I study for UGN-301.

Selling, general and administrative expenses for the first quarter 2023 were $24.5 million. This compares to $21.3 million for the same period in 2022. Increase to SG&A is primarily due to higher marketing, commercial, information technology, and advisory expenses, offset by lower market access, medical affairs and stock-based compensation expenses.

UroGen reported a noncash financing expense related to the prepaid forward obligation to RTW investments of $5.2 million for the first quarter 2023. UroGen reported a net loss of $30.2 million or a basic and diluted net loss per ordinary share of $1.30 for the first quarter 2023, as compared to $28.4 million or a basic and diluted net loss per ordinary share of $1.25 for the same period in 2022.

Turning to forward guidance. We reiterate anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 million to $86 million. We reiterate the full year 2023 operating expenses to be in the range of $135 million to $145 million, including noncash share-based compensation expense of $6 million to $11 million, subject to market conditions.

The company reiterates anticipated full year 2023 noncash financing expense related to the prepaid board obligation to RTW Investments in the range of $21 million to $26 million.

Of this amount, approximately $9.9 million to $11.2 million is expected to be in cash. We ended the first quarter with $75.2 million in cash and cash equivalents and marketable securities, which is expected to finance its operations into 2024.

To echo Liz, we are committed to diligently and proactively managing our balance sheet in support of our commercial and clinical development activities.

With that, I would like to turn the call over to operator for questions. Operator?

[Operator]

[Operator Instructions]. Our first question comes from the line of Ram Selvaraju of H.C. Wainwright & Co.

[Raghuram Selvaraju, H.C. Wainwright & Co.]

Firstly, I wanted to see if you could give us a sense of how long you expect it to take for the findings from the real-world retrospective analyses on JELMYTO to effectively begin to inform clinical practice. And to what extent you're seeing changes in clinical practice now, particularly with regard to the use of anterograde installation?

[Elizabeth Barrett, President, CEO & Director]

Thanks, John. Jeff, do you want to take a stab at it and Mark, you may want to add to that as well. So Jeff?

[Jeffrey Bova, Chief Commercial Officer]

Sure. Thanks. So the answer to the question is immediately. The reps are out there right now with new data. So physicians, urologists want to hear about the new study, particularly because it's how they practice. Typically, what they've been doing is endoscopically resecting and bringing in JELMYTO. They're able to see a better CR rate.

And so yes, I expect that to continue. I expect it to reinforce how physicians are using it for those that are using it. And then we're already seeing some big accounts come on board after there's been -- as you know, the significant buzz with the AUA and all of this data that's come out that is really opening doors to the territory business managers to talk about this new data. Regarding intergrade, your question, it continues to go up. The Dr. Rose data will certainly help justify the data that we see in and around the lower stenosis rate. It continues to go up and accounts continue to talk about getting it out of the hospital outpatient and bring it into their clinic. So it provides that flexibility to the physician with their patients as to whether or not they want to do it retrograde or antegrade.

[Mark Schoenberg, Chief Medical Officer]

Yes. Ram, the only thing I would add to that is that in a sort of a strange way, I think the publication is actually evidence that doctors are already using this in creative ways that were not originally explored in the OLYMPUS trial.

So I think it's very validating. And I support what Jeff said, we expect to see more and more of this. And I think the publication gives you an indication of what doctors will do with the C medication.

[Raghuram Selvaraju, H.C. Wainwright & Co.]

Okay. Great. And then can you just remind us what time line you expect the uTRACT registry study to be on and when you anticipate the potential publication of data from that study?

[Jeffrey Bova, Chief Commercial Officer]

I can comment to the time line. So we continue to recruit the investigators and get everything taken care of from an IRB standpoint. So that's going to continue through the remainder of the year. The data point -- I'll let Liz comment, but it's really sort of once you hit a number that is meaningful from a number of patients, whether that's retreatment, data, maintenance, ureteral only. A lot of things are being looked at and studied in the registry. But from my standpoint, it's really sort of when you get to that meaningful number of patients.

[Elizabeth Barrett, President, CEO & Director]

Yes. I mean nothing really to add here. I think it's an ongoing registry. So to Jeff's point, we'll continue to mine the data -- and when -- we have certain queries and as we feel like there's enough of a mass to be able to publish, we'll have an ongoing publication plan around the registry.

[Raghuram Selvaraju, H.C. Wainwright & Co.]

But it's not unreasonable to assume that in 2024 and possibly 2025, there would be useful information from the registry that could inform JELMYTO uptake, correct?

[Elizabeth Barrett, President, CEO & Director]

Yes, absolutely. Yes. I mean definitely, by 2024 yes, sure, if not earlier, sure. No, absolutely. We'll continue, like I said, I mean, Jeff commented, look, we want to understand more about maintenance. We want to understand more about retreatment. We want to continue to understand how physicians are using it. To Mark's point, -- so as soon as we -- we will, as I said, have an ongoing stream of data coming out. And to your point, we'll inform the optimal way to use it in real world.

[Raghuram Selvaraju, H.C. Wainwright & Co.]

Okay. And then last quick question for me is with respect to UGN-102, can you just give us a sense of how much larger the target market size is for UGN-102 versus JELMYTO and the extent to which you would be able to use physician awareness of JELMYTO to effectively give UGN-102 a running start, assuming that the ENVISION study data is positive and you receive timely regulatory approval.

[Elizabeth Barrett, President, CEO & Director]

Yes. That's a great question. As we mentioned earlier, there's about 80,000 patients who have what we consider to be intermediate risk non-muscle invasive bladder cancer as compared to the 6,000 to 7,000 patients with low-grade UTUC, which is a challenge, right?

We've always said all along that one of our key critical success factors for JELMYTO was patient identification, you don't have that issue or that challenge with UGN-102. Every doctor, as Mark commented about earlier in his prepared remarks, see these patients.

So it's not a situation where you're only going to see 1 or 2 of these patients a year, they see them on an ongoing basis and very familiar. And I do absolutely think what you said is that the usage of JELMYTO and even between now and then, the continued uptake, the continued adoption by new doctors will absolutely give us a head start with UGN-102 plus taking into consideration that the big difference here is the ease of use of UGN-102.

And most patients are really seen initially at the community level. and UGN-102 will be much easier, right, to be done in the clinic versus needing to go to a surgery center or a hospital where there is -- where you have the appropriate equipment.

So we know there's a lot of anticipation for UGN-102. And absolutely, what we've said all along is that JELMYTO proof-of-concept around our RTGel. But the biggest opportunity for us is, obviously, as we get into the larger patient population around bladder.

[Operator]

Our next question comes from the line of Paul Choi of Goldman Sachs.

[Roderick Ma, Goldman Sachs Group]

This is Roderick on for Paul. And so we have a couple of questions. And the first one is what kind of factors in invasion study? Do you think that it could help the UGN-102 to incrementally improve upon the 65% CR rate in the Phase IIb?

[Elizabeth Barrett, President, CEO & Director]

I'm not sure I really understand your question, but we don't expect, frankly, that there's anything different in the expectation around those studies. I think the important thing to note is typically, when you move to a larger Phase III study, you actually lose a little bit in the efficacy. But we -- our expectation is that the data will be meaningful. We feel like there's a lot of similarities between the two.

And from that standpoint, we're excited to see the data. But I don't -- Mark, do you have anything to add? Or I'm not sure if I misunderstood the question...

[Mark Schoenberg, Chief Medical Officer]

You understood it the way -- you understand the way I did, and I think it's important to remember that we're studying the same people that we studied in the Phase II.

So as Liz pointed out, we expect within reason for the results to be directionally similar.

[Roderick Ma, Goldman Sachs Group]

Got it. And just a follow-up question on that. So since the AUA presentations, has your sales force seeing any change in the physician interest in JELMYTO, what would probably increase the uptake on the forward based on the feedback from your sales force?

[Elizabeth Barrett, President, CEO & Director]

Yes, Jeff?

[Jeffrey Bova, Chief Commercial Officer]

Yes, short answer. If it was hard to ignore all of the -- what we had going at AUA between the 2 presentations, the AUA guidelines coming out, the product theater, the AUA really reinforcing what we have been saying for 4 years in and around preserving kidney function and not removing the kidney in this low-grade space.

Obviously, to hear it from us is one thing, but you hear it from colleagues, from urologists that basically says we should be doing everything to preserve the kidney. And obviously, JELMYTO is part of those guidelines. So super excited.

And obviously, it will be in waves. Some physicians that were there got it firsthand. Others that weren't able to attend, we'll continue to hear the guideline updates from their local representatives.

[Roderick Ma, Goldman Sachs Group]

Got it. Just to confirm, so your current cash runway, it's guided into 2024, right?

[Elizabeth Barrett, President, CEO & Director]

That's correct.

[Operator]

Thank you. Please stand by for our next question. Our next question comes from the line of Matt Kaplan of Ladenburg Thalmann.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Congrats on the first quarter results. Liz, could you talk a little bit more about the seasonality that you're seeing for JELMYTO? And what that means for the product?

[Elizabeth Barrett, President, CEO & Director]

Yes, absolutely. I'll actually ask Jeff to comment about that and happy to add any commentary at the end. So Jeff?

[Jeffrey Bova, Chief Commercial Officer]

Sure. So Matt, we see early on in the beginning of the year your typical patient co-pay resets. And so January is a past buildup. So we're building up patient enrollment forms that need to get through the donut hole. And then we -- we're seeing a strong start to as a result from the reset. And then your Q3, there is some seasonality with regards to folks taking vacation, not wanting to go into the OR 6x or the clinic 6x.

And so you see, again, sort of this past buildup in Q3 and hopeful continued strong Q4. So it's important for us to have that quarter, Q3 quarter this year over Q3 quarter last year, and continue to have that trend. But we do think that the seasonality is as common is common with Part B drugs with procedures in general. We do believe we'll continue to see that, particularly in the third quarter.

[Elizabeth Barrett, President, CEO & Director]

And the only comment I'll make additionally, Matt, is I think it's important to look at the difference between Q4 of '22 and Q1 of '23 versus last year. Point being the Q1 of '22 was about a $3 million drop from Q4 of '21. Whereas this year, it was about $1.5 million.

So we are seeing that gap close a little bit, and so are expecting the same thing sort of happen, if you remember, last year basically, Q3 was almost flat with Q2.

So while you didn't see the uptake quarter-over-quarter, you kind of saw sort of a flatness. So we expect that the difference in the quarter and seasonality will be muted compared to where it had been in the past. So while we do expect to continue to see that, we don't think it will be at the same level.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Okay. That's really helpful. And -- as we're thinking about the summer and the ENVISION and ATLAS readouts, can you give us a sense in terms of -- are you going to announce them at the same time? Or as one come before the other? And can you narrow the summer timing a little bit more? As well.

[Elizabeth Barrett, President, CEO & Director]

Yes, I wish I could. It's like I'm always saying like I wish the 12 months of follow-up from ENVISION that I can make those days go away. But that we're really sort of held by the time that it takes for the database lock and it's really around durability.

What I will tell you is that we're going to wait and do it all together. And the plan right now is to have sort of a virtual event where we share the data. We will be limited to the amount of data we can share because we do want to get it published both in a publication as well as presented at a medical meeting, but we will have both of those.

And I would say it won't be July 1, but maybe towards the end of July or the first half of August. So as soon as -- as soon as we have those sets of data, we'll want to share that, but the intention is to do it together at this point.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Okay. That's helpful. And what type of read-through do you think the ATLAS duration of response will provide for what to expect for ENVISION?

[Elizabeth Barrett, President, CEO & Director]

Yes. I mean, Mark, you may want to comment as well on this, but we expect it to be similar, right? The only difference -- Mark, why don't you just talk about maybe the differences between ENVISION and ATLAS and why we think that they'll be fairly similar.

[Mark Schoenberg, Chief Medical Officer]

Sure. As you -- I'm sure you remember, the ATLAS trial includes patients that have both new and recurrent intermediate risk disease, which is similar to what we saw in -- what we studied in the Phase II trial.

ENVISION is limited to patients who have recurrent disease only. We don't think that from a biologic or clinical perspective, that actually matters. And in our hands, so far patients with new and recurrent disease respond similarly to UGN-102. So our expectation is that you had ENVISION and ATLAS should look similar and that the ATLAS data should give us some indication as to what to expect from the ENVISION trial.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

All right. And then last question. As you complete the dose-ranging monotherapy for 301, what combinations with 301 are you contemplating to initiate later this year?

[Elizabeth Barrett, President, CEO & Director]

Mark, do you want to comment?

[Mark Schoenberg, Chief Medical Officer]

Yes, sure. So as you know, we've studied in our preclinical models, the combination of the anti-CTLA-4 antibody with UGN-201, which is our TLR7 agonist. So that is certainly a potential candidate. But we've obviously also thought long and hard about other potential both immunomodulators and chemotherapeutics. And so those are not off the table either, but certainly a plausible candidate would be UGN-201, Liz, may want to elaborate for you on that.

[Elizabeth Barrett, President, CEO & Director]

Yes, I agree. I think we haven't at all decided exactly which one will be first, but we could do multiple ones. So we're sort of evaluating what we think is the best one. But the TLR7, UGN-102, potentially partnering with others that we know are interested in doing combinations as well.

So I think it all depends on how those conversations go and what we sort of see is the one that makes sense and would want to quickly do that hopefully, again, in partnership with others.

[Operator]

Thank you. Please stand by for our next question. Our next question comes from the line of Rohan Mathur from Oppenheimer.

[Rohan Mathur, Oppenheimer]

Rohan here speaking on behalf of Leland Gershell. Just one question for me. So for UGN-102, what do you think regulatory authorities are looking for when it comes to efficacy and durability and low-grade NMIBC compared to high-grade? And what do you see 1 or 2 sitting in the current low-grade NMIBC paradigm alongside surgical intervention and current disease management?

[Elizabeth Barrett, President, CEO & Director]

Yes. Mark, why don't you start?

[Mark Schoenberg, Chief Medical Officer]

Sure. So in terms of what we think the regulators are looking for with respect to our Phase III program for UGN-102, it's the totality of the clinical data and clinical meaningfulness of the outcome. So that will be a combination, obviously, about the complete response rate and the durability of that response in complete responders.

There's no number attached to that. And Liz and I have previously said on multiple patients that in line with what we observed in our Phase II program, if that half of the patients achieve a complete response and half of those patients continue to maintain that response at 12 months follow-up, that would be clinically meaningful. But we need to see what the results are, obviously.

So hopefully, that gives you a sense of what we're at least thinking, but it will be the totality of the data.

In terms of where this will fit into clinical practice, there's already a discussion going on in our purity of literature about chemoablation as a primary approach to patients with recurrent non-muscle invasive disease, which is a big population of patients who represent a real clinical opportunity because these patients are as Liz has already alluded to, treated by chronic surgical intervention, which is an elderly population is a disadvantageous approach many think, including those of us at UroGen.

So we think that there is a real opportunity for primary therapy to replace transurethral resection in some patients with recurring disease, that's the group we're studying in the ENVISION trial. And then in terms of how this compares with high-grade disease, high-grade disease is a totally different animal, and the benchmarks and hurdles for approval are substantially different because of the nature of the disease.

So I'm not really sure, and Liz you may want to comment on this that it's a few comparison to make with the approach and the population we are studying.

[Elizabeth Barrett, President, CEO & Director]

Yes, I agree. It's probably not a fair comparison. The thing I will say is that when you hear and what do you see when you're looking at the competitive landscape, all of those drugs are being studied in high-grade disease. So you're hearing more and more from the FDA about wanting more comparative studies or wanting longer studies, that's because there's now multiple products being studied and approved in the high-grade space.

But that's actually not the case in the low-grade space. And we will be the only ones and we're the only ones that are anywhere near being in a Phase III. There's a couple of other that we hear about, but they're very early. And so I think we are in a very different situation -- in position because we'll be the only alternative for these patients.

I do think what we're seeing with JELMYTO, the whole idea, and we believe the biggest benefit for these patients is to have UGN-102 instead of having a TURBT. But just as we're seeing with JELMYTO, that use in addition to, you also may see that in real practice. But again, these patients, 75% of the patient population when we talk about 80,000, 75% of those are the recurrent pool. So they're the prevalent pool and those patients are recurring.

And we really see that about 68% have 2 or more recurrences and 25%, about 1/4 of them have 5 or more recurrences. So I think it's fair to say that the low-hanging fruit are these patients who have already going through these multiple recurrences. But we expect to be able to access that entire population.

[Operator]

Our next question comes from the line of Boris Peaker from Cowen.

[Boris Peaker, TD Cowen]

Great. First, on the ENVISION data, can you comment if the FDA said specifically you could file on 3-month data or if they'd like to see longer-term follow-up? What exactly is the hurdle for durability and follow-up from the regulatory perspective?

[Elizabeth Barrett, President, CEO & Director]

Yes, Mark, do you want to comment?

[Mark Schoenberg, Chief Medical Officer]

Yes. So we're not filing exclusively on the primary endpoint, which is the complete response rate in 3 months. The durability of that response and we've targeted 12 months following the assessment of complete response as the durability window for our assessment is key to the approval we think it demonstrates the value of the therapy compared to surgery. So it's a combination both with the complete response rate and the durability of response and Liz may want to elaborate also.

[Elizabeth Barrett, President, CEO & Director]

Yes. Just going to comment that the FDA made it very clear that durability is important, and we agree. And so while it is a secondary endpoint, it's an important secondary endpoint. So what we've decided and what we've talked about in the past is we'll file once we have 12 months of data on all patients in ENVISION. And that will allow us to go to the FDA with all patients at 12 months, some patients obviously beyond that.

And so -- and that we did something similar to that with an JELMYTO. We actually did a little bit earlier here. Again, we want to make sure we have all patients at 12 months. Look at the end of the day, to be honest with you, we're going to see what the data -- how the data plays out that we see this summer. And we'll start having conversations with the FDA as soon as possible and depending on the level of data that is we'll talk about them, how quickly can we get patients have access to this medicine.

[Boris Peaker, TD Cowen]

Got it. And then maybe on ATLAS, do you think the FDA will want to review the ATLAS study as well as part of the approval possibly considering the fact that...

[Elizabeth Barrett, President, CEO & Director]

Absolutely.

[Boris Peaker, TD Cowen]

More patients in ATLAS than ENVISION. So if that's the case, what do you think you need to show in ATLAS in parallel for the filing?

[Elizabeth Barrett, President, CEO & Director]

Yes. I think ATLAS and Mark may want to comment as well, is mostly going to be around safety. Because the data, as you know, we stopped the study. So the 280 patients remember, about half of those will be UGN-102, but about half of those will be TURBT, and so there'll be data but particularly around the safety of it, you won't be able to make comparisons.

The FDA won't be able to make comparisons because we didn't -- it wasn't powered to do so. And so we expect that the FDA is going to be mostly interested in the safety from that study.

[Operator]

Thank you. At this time, I see no more questions in the queue. I would like to now turn it back to Liz Barrett for closing remarks.

[Elizabeth Barrett, President, CEO & Director]

Thanks, and thanks, everybody. I mean, as you can see, it's an exciting time for us in 2023. I think I say every year, it's a pivotal year for us, but we've got a lot of catalysts this year. We need to continue. We will continue to execute on JELMYTO.

We feel like we have a lot of incremental data associated with JELMYTO and really showing how it's used. And so we expect to continue to see adoption. I will comment that so far in Q2, I know we talked about Q1, but we feel good about Q2 as well. Things are -- continue to advance for JELMYTO.

In addition to that, I think everybody is excited, and we hear a lot about UGN-102 and excited to see the data. Catalyst is coming up. So we look forward to staying in touch, and please let us know if you have any additional questions. But as always, thanks for your support and interest in our company. You can disconnect now, operator.

[Operator]

Thank you for your participation in today's conference. This concludes the program. You may disconnect.