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spk12: 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 Perrone, Head Investor Relations. You may begin.
spk09: Thank you, operator. Good morning, everyone. And welcome to Eurogen 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 31st, 2023. The press release can be accessed on the investors portion of our website at investors.eurogen.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 gel mito, anticipated seasonality for gel mito in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of Eurogen's product 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 your agenda explains any obligation to update these statements. I will now turn the call over to Liz. Liz?
spk05: Thank you, Vincent, and thank you to everyone joining us today. Urigin 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 Gemido, 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 tract urothelial cancer. In achieving this goal, we have demonstrated the viability of intravascular delivery of chemotherapy and our proprietary RT gel 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 gel mito net revenues were $17.2 million, our second best quarter ever since launch, and a 27% increase from the same quarter one year prior. While continued growth in gel mito 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 gel mito 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, two additional studies reinforcing the utility and efficacy of gel mito 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 UGM-102 and its several near-term catalysts. Specifically, we remain on track to provide top-line data from our Phase III studies of UGM-102 this summer. For Envision, we anticipate providing the primary endpoint of complete response rate for 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 envisioned 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 UGM-102, which demonstrated a 65 percent complete response rate and duration of response at 12 months of 72.5 percent using Kaplan-Meier analysis. We believe UGM-102 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 for fluoroscopy. Therefore, if approved, we anticipate UGM-102 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. 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, gel mito cells and UGM-102 development. Given what we believe is a significant market potential for UGM-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?
spk02: Thank you, Liz, and hello, everyone. I'd like to begin by commenting on two recent Jelmido 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 gel mito in treating ureteral tumors. In this analysis, 47 patients had UTC tumors involving the ureter, with 12 cases of ureteral tumor only and 35 cases of ureteral plus renal pelvic tumors. 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. Fourteen 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 Dr. Craig Labatt and colleagues and highlighted results of a sub-analysis from the same post-commercialization review of Jomito. The study aimed to evaluate efficacy and safety of gel mito 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 UTC 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 mito treatment was 23% compared to 44% observed in the Olympus study. The authors also note that UTC 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 UTC patients by six 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. 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 U-TRAC 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-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'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 II Optima II trial of UGN-102, which demonstrated a 65% complete response rate And duration of response at 12 months is 72.5% using a Kaplan-Meier analysis. EGN-102 also has key similarities with gel mito. Both products utilize mitomycin, allow for local delivery and sustained exposure to mitomycin for up to six 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. UGM-102, 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 in 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 UGN301, our in-licensed anti-CTLA-4 antibody for intravascular administration using RT-GL technology, continues to enroll. UGN301 is in development for use in combination with other immunomodulators, including UGN201, 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 II trial. The first arm of this study, evaluating dose ranges of UGN301 as monotherapy, is expected to be completed later this year. Results from this arm will inform the appropriate dose of UGN301 for our first combination arm, which could potentially begin before the end of the year. We view UGN301 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.
spk10: Jeff? 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 gel mito since launch. Adoption metrics in the first quarter continue to demonstrate encouraging trends in the new and repeat accounts. Activated sites on May 1st, 2023 were 1,009, compared to 983 on March 1st, 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 gel mito. 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 mito 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 gel mito 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 gel mito can be a treatment option as a part of a kidney-sparing approach to disease management. With the use of gel mito 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 gel mito can have in treating low-grade tumors. Our booth featured demonstrations on how our innovative RT gel technology is advancing care in 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 acknowledgement 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 gel mito. and prospectively introduce UGM-102. With that, I'll turn the call over to Don to discuss our financials. Don?
spk01: 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 31st, 2023. For the first quarter of 2023, we reported J-MITO 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 InVision Trial manufacturing, and clinical compensation offset by higher RMD expense related to the phase one study for UGN 301. Selling, general, and administrative expenses for the first quarter of 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. Eurogen reported a non-cash financing expense related to the prepaid forward obligation to RTW investment of $5.2 million for the first quarter of 2023. Eurogen reported a net loss of $30.2 million or basic and diluted net loss for ordinary share of $1.30 for the first quarter 2023, as compared to $28.4 million, or basic and diluted net loss for 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 Jermiter to be in the range of $76 to $86 million. We reiterate full-year 2023 operating expenses to be in the range of $135 to $145 million, including non-cash share-based compensation expense of $6 to $11 million, subject to market conditions. The company reiterates anticipated full year 2023 non-cash financing expense related to the prepaid forward obligation to RTW investments in the range of $21 to $26 million. Of this amount, approximately $9.9 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?
spk12: Thank you. At this time, we will be conducting the question and answer session. If you would like to ask a question, you will need to press star 11 on your telephone. Once again, that's star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
spk07: Please stand by while we compile the Q&A roster.
spk12: Our first question comes from the line of Ram Salivaju of H&C Wainwright and Company. Your line is now open.
spk13: 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 mito 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.
spk05: Thanks, Ram. Jeff, do you want to take a stab at it? And Mark, you know, you may want to add to that as well. So, Jeff.
spk10: Sure. Thanks. And hi, Ram. 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 gel mito. They're able to see a better CR rate. And so, yeah, 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, this significant buzz with the AUA and all of this data that's come out that has really opened doors to the territory business managers to talk about this new data. Regarding antegrade, 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 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.
spk03: Yeah, Ron, the only thing I would add to that is that in a sort of 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 simply gives you an indication of what doctors will do with this new medication okay great and then uh can you just remind us what timeline you expect the utract registry study to be on
spk13: and when you anticipate the potential publication of data from that study?
spk10: 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 meaningful number of patients.
spk05: Yeah, I mean, nothing really to add here. I think, you know, it's an ongoing registry. So, to Jeff's point, we'll continue to mine the data. And when, you know, we have certain queries and as, you know, as we feel like there's enough, you know, enough of a, you know, mass to be able to publish, we'll have an ongoing publication plan around the registry.
spk13: But it's not unreasonable to assume that in 2024 and possibly 2025, there would be useful information from the registry that could inform gel mito uptake, right?
spk05: Oh, yeah, absolutely. Yeah, I mean, definitely by 2024. Yeah, sure, if not earlier, sure. No, absolutely. We'll continue, you know, 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, you know, continue to understand how physicians are using it. To Mark's point, So as soon as we, so we will, as I said, have an ongoing stream of data coming out and to your point, will inform, you know, the optimal way to use it in real world.
spk13: Okay. And then last quick question from 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 gel mito and the extent to which you would be able to use physician awareness of gel mito To effectively give a running start, assuming that the envisioned study data is positive and you receive timely regulatory approval.
spk05: Yeah, no great question. You know, as we mentioned earlier, there's about 80,000 patients who have what we consider to be intermediate risk. Non Muslim based of bladder cancer is compared to the 6 to 7000 patients with low grade. Which is a challenge, right? We all we've always said all along that 1 of our key critical success factors for John Mito was patient identification. You don't have that issue, you know, or that challenge with 1 of 2. Every doctor is Mark commented about earlier in his prepared remarks. You know, see these patients, so it's not a situation where you're only going to see 1 or 2 of these patients a year. You know, they see him on an ongoing basis and very familiar and I do absolutely think what you said. Is that that, you know, the usage of and, you know, even between now, and then the continued uptake, the continued adoption by new doctors will absolutely give us a head start with new GM. One of two plus taken into consideration that the big difference here is the ease of use of. And most patients are really seen initially at the community level, and UGM-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, you know, where you have the appropriate equipment. So, you know, we know there's a lot of anticipation for UGM-102, and absolutely what we've said all along is that Gemido, you know, is proof of concept around our RT-gel. But the biggest opportunity for us is obviously as we get into the larger patient population around bladder.
spk07: Thank you.
spk05: Thanks. Appreciate it.
spk12: Thank you for your questions.
spk07: Please stand by while we compile the Q&A roster. Our next question comes from the line of Paul Choi of Goldman Sachs.
spk12: Your line is now open.
spk06: Hi. Thanks for taking our questions. This is 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 EUGN102 to incrementally improve upon the 65% CR rate in the Phase IIb?
spk05: 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 three study, you actually lose a little bit in the efficacy. But our expectation is that the data will be meaningful. We feel like there's a lot of similarities between the two. And, you know, from that standpoint, you know, 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've misunderstood the question.
spk03: No, you understood it the way I, 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 two. So, as was pointed out, we expect, you know, within reason for the results to be directionally similar.
spk06: Got it. Thanks for that. And just a follow-up question on that. So since the AUA presentations, has your sales force seen any change in the physician interest in gel mito? What will probably increase the uptake on the forward based on the feedback from your sales force?
spk05: Yeah, Jeff?
spk10: 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 four 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, you know, we should be doing everything to preserve the kidney. And obviously, gel mito was part of those guidelines. So, super excited. And, you know, obviously, it'll be in waves. Some physicians that were there got it firsthand. Others that weren't able to attend will continue to hear the guideline updates from their local representatives.
spk06: Got it. Just to confirm, so your current cash runway is guided into 2024, right?
spk05: That's correct.
spk06: Okay, got it.
spk05: Thank you. Thanks, Roderick. Appreciate it.
spk12: Thank you.
spk07: Please stand by for our next question. Our next question comes from the line of Matt Kaplan of Ladenburg Thalmann.
spk12: Your line is now open.
spk08: Thank you and good morning and congrats on the first quarter results. Liz, could you talk a little bit more about the seasonality that you're seeing for gel mito and what that means for the product?
spk05: Yeah, absolutely. I actually asked Jeff to comment about that and happy to add any commentary at the end.
spk10: Sure, so we see early on the beginning of the year, your typical patient copay resets. And so January is a path build up. So we're building up patient enrollment forms that need to get through the donut hole. And then we were saying a strong start to Q2 as a result from from the resets. And then your Q3, there's some seasonality with regards to folks taking vacation, not wanting to go to the OR six times or the clinic six times. And so you see, again, sort of this PEF buildup in Q3 and hopeful continued strong Q4. So, you know, 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 common with Part B drugs with procedures in general. We do believe we'll continue to see that, particularly in the third quarter.
spk05: and the only comment i'll make additionally matt is um i think it's important to look at um the the difference between q4 of 22 and q1 of 23 versus last year um point being the the q1 of 22 was about a three million dollar drop from q4 of 21 whereas this year was you know it was about a million and a half 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, you know, basically Q3 was, you know, almost flat with Q2. So while you didn't see the, you know, uptake quarter over quarter, you kind of saw, you know, sort of a flatness. So we expect that the difference in the corn seasonality will be, you know, 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.
spk08: Okay, that's really helpful. Thank you. 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 is one come before the other? And can you narrow the summer timing for us a little bit more?
spk05: as well um yeah i wish i could you know it's like i'm always saying you know like i wish the 12 months of follow-up from envision that i can make those those days go away but um you know that you know we're really sort of held by by the time that it takes you know for the database database lock and it's really around durability what i will tell you that we're going to wait and do it all together and i'm in the plan right now is to you know have you know 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, you know, at a medical meeting. But we will have both of those. And, you know, I would say, you know, it wouldn't, it won't be July 1st, but, you know, maybe toward the end of July or the first half of August. So, as soon as we have both sets of data, you know, we will want to share that. But the intention is to do it together. Yeah, at this point.
spk08: 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 InVision?
spk05: Yeah, I mean, you know, and Mark, you may want to comment as well on this, but, you know, we expect it to be similar, right? The only difference, you know, Mark, why don't you just talk about maybe the differences between InVision and ATLAS and why we think that they'll be fairly similar?
spk03: Sure. Thanks, Matt. As 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 studied in the Phase 2 trial. Envision is limited to patients who have recurrent disease only. We don't think that from a biological or clinical perspective that actually matters. And in our hands so far, patients with new and recurrent disease respond similarly to UGM-102. 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.
spk08: 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?
spk05: Mark, you want to comment?
spk03: Yeah, sure. So as you know, we've studied in our preclinical models the combination of the anti-CTLA-4 antibody with the 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 UGM 201. Liz may want to elaborate further on that.
spk05: Yeah, I agree. I think we haven't at all decided, you know, exactly which one will be first, but, you know, we could do multiple ones. So, you know, we're sort of evaluating what we think is the best one. But the TLR7, UGM 102, you know, 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 as the one that makes sense and would want to quickly do that, hopefully, again, in partnership with others.
spk08: Great. Thanks, guys.
spk05: Thank you. Thanks, Matt.
spk12: Thank you.
spk07: Please stand by for our next question. Our next question comes from the line of Rohan Mathur from
spk12: Oppenheimer, your line is now open.
spk11: Hey, guys. Ron here speaking on behalf of Lee and Gerschel. 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 in low-grade MIBC compared to high-grade? And what do you see 102 fitting in the current low-grade MIBC paradigm alongside surgical intervention and current disease management? Thank you.
spk05: Yeah, Mark, why don't you start? Sure.
spk03: so in terms of what we think the regulators are looking for with respect to our phase three program for ugm 102 it's the totality of the clinical data and clinical meaningfulness of the outcome so that'll be a combination obviously about the complete response rate and the durability of that response in complete responders uh there's no number attached to that uh and this and i have previously said on multiple occasions that you know in in in line with what we observed in our phase two 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. 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 review 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 in an elderly population is a disadvantageous approach, many think, including those with severe urgence. We think that there is a real opportunity for primary therapy to replace transrethrosection in some patients with recurrent disease. That's the group we're studying in the ENVISION trial. And then in terms of how this compares with high-grade disease, you know, 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 may want to comment on this, that it's a fair comparison to make with the approach and the population we're studying.
spk05: Yeah, 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 know, 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. And we will be the only ones, and we're the only ones that are anywhere near, you know, being in a phase three. There's, you know, a couple of other, you know, that we hear about, but they're very early. And so, you know, I think we're in a very different situation and position because we'll be the only alternative, you know, for these patients. I do think what we're seeing with gel mito, the whole idea, and we believe the biggest benefit for these patients, is to have UGM-102 instead of having a T or a BT. But just as we're seeing with gel mito, the use in addition to, you also may see that in real practice. But again, these patients, you know, 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, you know, about 68% have two or more recurrences and 25%, you know, about a quarter of them have five or more recurrences. So I think it's fair to say that, you know, the low hanging fruit are these patients who are already going through these multiple recurrences. But, you know, we expect to be able to, you know, access that entire population.
spk07: Thank you. Thank you.
spk05: Appreciate it.
spk07: Thank you. Please stand by for our next question. Our next question comes from the line of Boris Beaker from TD Cohen.
spk12: Your line is now open.
spk04: Great. Thanks for excusing me. First, on the Envision data, Can you comment if the FDA said specifically you could file on three 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?
spk05: Yeah, Mark, you want to comment?
spk03: Yeah, so we're not filing exclusively on the primary endpoint, which is the complete response rate of three 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 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.
spk05: Yeah. 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 a, 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 and vision, and that will allow us to go to the FDA with all patients at 12 months from patients obviously beyond that. Um, 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. But 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, you know, we'll start having conversations with the FDA as soon as possible. And depending on the level of data that that is, we'll talk about them, you know, how quickly can we get patients to have access to this medicine.
spk04: 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? I mean, considering the fact that there's more patients in ATLAS than envisioned. So if that's the case, what do you think you need to show in ATLAS in parallel for the filing?
spk05: Yeah, 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, You know, about half of those will be UGM-102, but about half of those will be TRBT. And so, you know, 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.
spk04: Great. Thank you very much for taking my questions.
spk05: Thanks, Boris.
spk12: 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.
spk05: 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 Jalmaito. We feel like we have a lot of, you know, incremental data associated with gelmito 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, you know, we talked about Q1, but we feel good about Q2 as well. You know, things are, you know, continue to advance for gelmito. In addition to that, I think everybody's excited and we hear a lot about UDM-102 and excited to see the data. you know, catalyst as coming up. So, you know, we look forward to staying in touch and, you know, 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.
spk12: Thank you for participation in today's conference. This concludes the program. You may disconnect.
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