UroGen Pharma Q1 2023 Earnings Call Transcript

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Provided by Quartr
May 11, 2023

There are 10 speakers on the call.

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen 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 Perron, Head of Investor Relations. You may begin.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's Q1 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. Eurogen.com.

Speaker 1

Joining me on the call today are Liz Barrett, President and Chief Executive Officer Doctor. 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 gelmito, anticipated seasonality for gelmito in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UroGen's product and product candidates to transform the treatment paradigm of urothelial and specialty cancers, market opportunities, potential future commercialization activities for UGN-one hundred and two if approved, data presentations, regulatory filings, future R and 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.

Speaker 1

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?

Speaker 2

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 JALMIDO, we took an important first step in bringing to market an innovative non surgical therapy designed to improve the standard of care for treating low grade upper tractuothelial 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-one hundred and two, 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's Yalmayto net revenues were $17,200,000 our 2nd best quarter ever since launch and a 27% increase from the same quarter 1 year prior.

Speaker 2

While continued growth in gel myto 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 JALMIDO are increasingly recognized in the real 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 Jack will provide highlights from the conference, but at a high level, 2 additional studies reinforcing the utility and efficacy of JALMIDO 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-one hundred and two and its several near term catalysts. Specifically, we remain on track to provide top line data from our Phase 3 studies of UGN-one hundred and two this summer.

Speaker 2

For ENVISION, we anticipate providing the primary end of complete response rate of approximately 240 patients who completed this 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.

Speaker 2

Our optimism in the potential outcome of Envysion stems from a similarity to the Phase II OPTIMA II trial of UGM-one hundred and two, which demonstrated a 65% complete response rate and duration of response at 12 months of 72.5% using Kaplan Meier analysis. We believe UGM-one hundred and two can be a transformational product and represent a significant opportunity to address a much larger patient population. Unlike JALMIDO, administration is much simpler without the need fluoroscopy. Therefore, if approved, we anticipate UGM-one hundred and two will be a significant driver of future growth as it will be the only primary non surgical therapy addressing the nearly 80,000 new patients in the U. S.

Speaker 2

Alone, who will undergo repetitive endoscopic resection and are burdened 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, gelmato sales and UGM-one hundred and two development. Given what we believe is a significant market potential for UGM-one hundred and two, 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.

Speaker 2

Mark?

Speaker 3

Thank you, Liz, and hello, everyone. I'd like to begin by commenting on 2 recent gel myto 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 Doctor. Joseph Jacob and colleagues and highlighted results from a sub analysis of the first and largest post commercial utilization review of gel Mito in treating ureteral tumors. In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only and 35 cases of ureteral plus renal pelvic tumors.

Speaker 3

Data from this study demonstrated no difference in gel Mito outcomes at first endoscopic evaluation based on tumor location, adding to the growing body of real world evidence supporting broad use of gel Mito in treating low grade UTC 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 pre existing hydronephrosis, which is the buildup of excess fluid in the kidney due to a backup of urine. The second study was conducted by Doctor.

Speaker 3

Craig Labad and colleagues and highlighted results of a sub analysis from the same post commercialization review of JEL MITEO. The study aimed to evaluate efficacy and safety of JELMIDO 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 gel Mito 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 gel Lido treatment was 23% compared to 44% observed in the OLYMPUS study.

Speaker 3

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 UQDC 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 gel Mito 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.

Speaker 3

To further explore the full potential of gel Mito for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective UTRAC registry to capture data in a large scale standardized manner to report further on patient outcomes following gel Mito treatment, including longitudinal follow-up. I'd like to turn now to UGN-one hundred and two, 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're 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 2 OPTIMA 2 trial of UGN-one hundred and two, which demonstrated a 65% complete response rate and duration of response of 12 months to 72.5% using a Kaplan Meier analysis. UGM-one hundred and two also has key similarities with JALMIDA.

Speaker 3

Both products utilize 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-one hundred and two, however, has several unique advantages over gel Mito, 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 10 times more common and a condition that is routinely managed by 80% to 90% of urologists, inferring a significantly larger addressable patient population.

Speaker 3

Meanwhile, our Phase 1 trial with UGN-three zero one, our in license anti CTLA-four antibody for intravestible administration using RTGel technology continues to enroll. UGN-three zero one is in development for use in combination with other immunomodulators, including UGN-two zero one, our proprietary TLR7 agonist, and other potential chemotherapy and immunotherapies to treat high grade NMIBC. This study is aimed at identifying the suitable dose for a subsequent Phase 2 trial. The first arm of this study evaluating dose ranges of UGN-three zero one as monotherapy is expected to be completed later this year. Results from this arm will inform the appropriate dose of UGN-three zero one for our first combination arm, which could potentially begin before the end of the year.

Speaker 3

We view UGN-three zero one 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?

Speaker 1

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 2nd strongest quarter for gel my dose since launch. Adoption metrics in the Q1 continued 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, 2020 3 and repeat accounts were 235 compared to 214 for the same period. Reimbursement remains at approximately 99% across all coverage types.

Speaker 1

During the Q1, 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 Jomaito. 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 gel myto across various practice patterns.

Speaker 1

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 GelMido 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 gelmyto can be a treatment option as a part of a kidney sparing approach to disease management. With the use of gelmyto in a multimodal regimen, mito in a multimodal regimen, patients with UTUC can achieve a durable complete response.

Speaker 1

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 gel uro oncology and allowed the team to meet with physicians. It also included a product theater featuring KOL's Jennifer Linehan and Sandeep Prasad, which focused on the gel Mito 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 societies and we look forward to continuing to work with the AUA and SUO as we further develop and expand JELD MIVO and prospectively introduce UGN-one hundred and two. With that, I'll turn the call over to Don to discuss our financials.

Speaker 1

Don?

Speaker 4

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 Q1 ended March 31, 2023. For the Q1 of 2023, we reported J Mito net product revenues of $17,200,000 in line with the consensus estimates and an increase of 27% compared to $13,600,000 in the same period last year. For the Q1 of 2023, research and development expenses were $12,500,000 as compared to $12,700,000 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 and D expense related to the Phase I study for UGN-three zero one.

Speaker 4

Selling, general and administrative expenses for the Q1 2023 were $24,500,000 This compares to $21,300,000 for the same period in 2022. The increase to SG and 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. Eurovision reported non cash financing expense related to the prepaid forward obligation to RTW Investment of $5,200,000 for the Q1 2023. EuroGen reported a net loss of $30,200,000 or basic and diluted net loss for ordinary share of $1.30 for the Q1 of 2023 as compared to $28,400,000 or basic and diluted net loss per ordinary share of $1.25 for the same period in 2022. Turning to forward guidance.

Speaker 4

We reiterate anticipated full year 2023 net product revenues from gel miter to be in the range of $76,000,000 to $86,000,000 We reiterate the full year 2023 operating expenses to be in the range of $135,000,000 to $145,000,000 including non cash share based compensation expense of $6,000,000 to $11,000,000 subject to market conditions. The company reiterates anticipated full year 2023 non cash financing expense related to the prepaid forward obligation to RTW Investment in the range of $21,000,000 to $26,000,000 Of this amount, approximately $9,900,000 to $11,200,000 is expected to be in cash. We ended the Q1 with $75,200,000 in cash and cash equivalents and marketable securities, which is expected to finance its operations into 2024. To echo this, 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.

Speaker 4

Operator?

Operator

Thank Our first question comes from the line of Ram Selvaraju of H&C Wainwright and Company. Your line is now open.

Speaker 5

Hi, thanks very much for taking my questions. 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 gel myto 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?

Speaker 2

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

Speaker 1

Sure. Thanks. And hi, Ram. So the answer to the question is immediately. The reps are out there right now with new data.

Speaker 1

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 gel myto. 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.

Speaker 1

Regarding ANSAGRADE, your question, it continues to go up. The Doctor. 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 bringing 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 integrate.

Speaker 3

Yes. Ram, the only thing I would add to that is that in a sort of strange way, I think the publications 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 that gives you an indication of what doctors will do with this new medication.

Speaker 4

Okay, great.

Speaker 5

And then can you just remind us what timeline you expect the UTRAX Registry study to be on and when you anticipate the potential publication of data from that study?

Speaker 1

I can comment to the timeline. 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, ureterol 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 it's an ongoing registry.

Speaker 1

So

Speaker 2

to Jeff's point, we'll 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.

Speaker 5

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

Speaker 2

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.

Speaker 2

So as soon as we so we will, as I said, have an ongoing stream of data coming out and to your point, we'll inform the

Speaker 5

target market the target market size is for UGN-one hundred and two versus gel Mito? And the extent to which you would be able to use physician awareness of gel Mito to effectively give UGN-one hundred and two a running start assuming that the ENVISION study data is positive and you receive timely regulatory approval?

Speaker 2

Yes. Great question. As we mentioned earlier, there's about 80,000 patients

Speaker 4

who have

Speaker 2

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 JALMIDA was patient identification. You don't have that issue or that challenge with UGM-one hundred and two. 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.

Speaker 2

They see them on an ongoing basis and very familiar. And I do absolutely think what you said is that the usage of JYALMIDO and even between now and then, the continued uptake, the continued adoption by new doctors will absolutely give us a head start with UGM-one hundred and two, plus taking into consideration that the big difference here is the ease of use of UGM-one hundred and two. And most patients are really seen initially at the community level and UGM-one hundred and two 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 UGM-one hundred and 2 and absolutely what we've said all along is that JALMIDO is proof of concept around our RTG But the biggest opportunity for us is obviously as we get into the larger patient population around bladder.

Operator

Thank you. Thanks.

Speaker 2

Appreciate it.

Operator

Thank you for your questions. Please stand by while we compile the Q and A roster.

Speaker 1

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

Operator

Your line is now open.

Speaker 6

Hi, thanks for taking our questions. 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-1 hundred and two to incrementally improve upon the 65% CER rate in the Phase 2b?

Speaker 2

I'm not sure I really understand your question, but we don't expect, frankly, that if 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 3 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 2. And from that standpoint, we're excited to see the data.

Speaker 2

But I don't Mark, do you have anything to add? Or I'm not sure if I misunderstood Roderick?

Speaker 3

No, you understood it 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 2. So as Liz pointed out, we expect within reason for the results to be directionally similar.

Speaker 6

Got it. Thanks for that. And just a follow-up question on that. So since the AOA presentations, has your sales force seen any change in the physician interest in JALMAYTO? What will probably increase the uptake on the forward based on the feedback from your sales force?

Speaker 2

Yes, Jeff?

Speaker 1

Yes, short answer. It was hard to ignore all of the what we had going at AUA between the two 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 to hear it from colleagues, from urologists that basically says, we should be doing everything to preserve the kidney and obviously, GelMida was 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.

Speaker 1

We'll continue to hear the guideline updates from their local representatives.

Speaker 6

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

Speaker 2

That's correct.

Operator

Okay, got it. Thank you.

Speaker 2

Thanks, Roderick. Appreciate it.

Operator

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

Speaker 7

Thank you and good morning and congrats on the Q1 results. Liz, could you talk a little bit more about the seasonality that you're seeing for Gelmido and what that means for the product?

Speaker 2

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

Speaker 1

Sure. So hi, Matt. We see early on the beginning of the year, your typical patient co pay resets. And so January is a PEP buildup. So we're building up patient enrollment forms that need to get through the donut hole.

Speaker 1

And then we're seeing a strong start to Q2 as a result from the reset. And then your Q3, there are some seasonality with regards to the folks taking vacation, not wanting to go to the OR 6 times or the clinic 6 times. And so you see again sort of this PEP 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 with Part B drugs with procedures in general.

Speaker 1

We do believe we'll continue to see that, particularly in the Q3.

Speaker 2

And the only comment I'll make additionally, Matt, is I think it's important to look at the difference between Q4 of 2022 and Q1 of 2023 versus last year. Point being, the Q1 of 2022 was about a $3,000,000 drop from Q4 of 2021, whereas this year it was about $1,500,000 So we are seeing that gap close a little bit. And so our expect and the same thing sort of happened. 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.

Speaker 2

So we expect that the difference in the quarter and seasonality will be metered 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.

Speaker 7

Okay. That's really helpful. Thank you.

Speaker 2

And as we're thinking about the summer

Speaker 7

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 is one come before the other? And can you narrow the summer timing for us a little bit more as well?

Speaker 2

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 in the plan right now is to have sort of a virtual event where we share the data.

Speaker 2

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 wouldn't it won't be July 1, but maybe toward the end of July or the first half of August. So as soon as we have both sets of data, we will want to share that. But the intention is to do it together, yes, at this point.

Speaker 7

Okay. That's helpful. And what

Speaker 5

type of read through do

Speaker 7

you think the Atlas duration of response will provide for what to expect for Envision?

Speaker 2

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 My, we think that they'll be fairly similar.

Speaker 3

Sure. Thanks, Matt. 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.

Speaker 3

And in our hands so far, patients with new and recurrent disease respond similarly to UGN-one hundred and two. So our expectation is that 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.

Speaker 7

All right. Thanks, Mark. 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?

Speaker 2

Mark, you want to comment?

Speaker 3

Yes, sure. So as you know, we've studied in our preclinical models, the combination of the anti CTLA-four antibody with the UGN-two zero one, which is our TLR-seventy 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-two zero one.

Speaker 3

Liz, may you want to elaborate further on that?

Speaker 2

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 TLR-seven, UGM-one hundred and two, 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.

Speaker 4

Great.

Speaker 7

Thanks guys.

Speaker 2

Thank you. Thanks Matt.

Operator

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

Speaker 8

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

Speaker 2

Yes. Mark, why don't you start?

Speaker 3

Sure. So in terms of what we think the regulators are looking for with respect to our Phase 3 program for UGM-one hundred and two, it's the totality of the clinical data and clinical meaningfulness of the outcome. So So that will be a combination obviously of both the complete response rate and the durability of that response in complete responders. There's no number attached to that. And as this and I have previously said on multiple patients that in line with what we observed in our Phase 2 program, if about 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.

Speaker 3

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 peer reviewed literature 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 Luis has already alluded to, treated by chronic surgical intervention, in an elderly population is a disadvantageous approach, many think, including those with UroGen. So we think that there is a real opportunity for primary therapy to replace transurethral resection in some patients with recurrent disease. That's the group we're studying in the ENVISION trial.

Speaker 3

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, Elizabeth may want to comment on this, that it's a fair comparison to make with the approach and the population we're setting.

Speaker 2

Yes, I agree. It's probably not a fair comparison. The thing I will say is that what 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, as 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.

Speaker 2

So we will be the only ones and we're the only ones that are anywhere near being in a Phase 3. There's a couple of other that we hear about, but they're very early. And so I think we're in a very different situation and position because we'll be the only alternative for these patients. I do think what we're seeing with JALMIDO, the whole idea and we believe the biggest benefit for these patients is to have UGM-one hundred and two instead of having a TURBT, but just as we're seeing with Yalmayto that used 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.

Speaker 2

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 a quarter 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 are already going through these multiple recurrences. And but we expect to be able to access that entire population.

Speaker 4

Thank you.

Speaker 2

Thank you. Appreciate it.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Boris Beaker from TD Cowen. Your line is now open.

Speaker 9

Great. Thanks for squeezing me in. First on the Envision data, can you comment if the FDA said specifically you could file on 3 months 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?

Speaker 2

Yes. Mark, you want to comment?

Speaker 7

Yes. So

Speaker 3

we're not filing exclusively on the primary endpoint, which is the complete response rate of 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 and it demonstrates the value of the therapy compared to surgery. So it's a combination both of the complete response rate and that durability of response and Liz may want to elaborate also.

Speaker 2

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 vision. And that will allow us to go to the FDA with all patients at 12 months, some patients obviously beyond that.

Speaker 2

And so and that we did something similar to that with John Mito. 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, I'll 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.

Speaker 2

And depending on the level of data that that is, we'll talk about them how quickly can we get patients having access to this medicine.

Speaker 9

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 process and considering the fact that

Speaker 2

Absolutely.

Speaker 9

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

Speaker 2

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 there the 2 80 patients, remember, about half of those will be UGM-one hundred and two, but about half of those will be TRBT. 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.

Speaker 2

Great.

Speaker 9

Thank you very much for taking my questions.

Speaker 2

Thanks, Boris.

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.

Speaker 2

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 pivotal year for us, but we've got a lot of catalysts this year. We want we need to continue. We will continue to execute on JALMIDO.

Speaker 2

We feel like we have a lot of incremental data associated with JALMIDO 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 DelMaido. In addition to that, I think everybody is excited and we hear a lot about UGM-one hundred and two and excited to see the data catalyst that's coming up.

Speaker 2

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.

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Earnings Conference Call
UroGen Pharma Q1 2023
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