UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Eurogen Pharma second quarter, 2022 . And then my pleasure to turn the call over to Vincent Perrone, Senior Director of Investor Relations for Eurogen Pharma. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to EuroGen Pharma's second quarter 2022 financial results and business update conference call. Earlier today, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30th, 2022. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me today are Liz Barrett, President and CEO, 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 relating to Gelmido, our ongoing and planned research efforts and clinical trials, the potential benefits of Gelmido and our product candidates, data presentations, regulatory filings, future revenue opportunities, potentially reaching cash flow breakeven by 2025, the availability of the second tranche of our term loan facility, and 2022 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, including under the risk factors heading of our quarterly report on Form 10-Q for the quarter ended June 30th, 2022, filed today. who are cautioned not to place undue reliance on these forward-looking statements, and your agendas claims any obligation to update these statements. I'll now turn the call over to Liz. Liz?

Thank you, Vincent, and thank you to everyone joining us today. As summarized in this morning's press release, our progress through the second quarter of 2022 can primarily be viewed along three lines. First is the continued growth of our gel mito revenue. Second is the on-pace enrollment of our clinical programs And the third is further strengthening of the body of evidence, underscoring the benefit of John Mito in a real-world setting. The common thread between each of these areas is disciplined execution and determined commitment from our entire team to deliver benefit to patients and value to shareholders, which I am pleased to discuss in more detail with you today. Our overarching goal remains to fundamentally transform the treatment paradigm for patients suffering from urothelial or specialty cancers. reflecting a largely underserved patient population with a crucial need for novel therapies. Our currently approved medicine, Gelmito, is a prime example of filling a need with a kidney-sparing option for patients suffering from low-grade upper tract ulcerative carcinoma. And I'm pleased to report that we continue to see increased adoption with net revenue of $16.6 million, a year-over-year growth of 28%, and 22% growth over Q1. Jeff will describe our commercial results in more detail, including a review of real-world gel mito outcomes data recently presented at AUA. But we remain confident in our original guidance and expect growth and acceleration of gel mito adoption throughout the remainder of 2022. Beyond gel mito, our two ongoing clinical trials are actively underway and enrolling at expected rates. Most importantly, our Envision Phase III Pivotal Study of UGN-102, a novel medicine in development to treat patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer, remains on track for full enrollment by year-end. Assuming positive data, we anticipate filing an NDA with the FDA in 2024 and would target a priority review, which may allow for approval by the end of 2024. If approved, UGM-102 will be the first non-surgical primary therapeutic to treat these patients. Post-approval, we anticipate a streamlined launch given we are able to leverage our established commercial framework with a common prescriber base and similar product features with Jalmido. Based on market research, we believe UGM-102 addresses a large patient population of 80,000 patients in the U.S. alone, and foresee a potential combined revenue of over a billion dollars for UGM-102 and Jalmito by 2027. Concurrently, our first in human study to evaluate the safety and tolerability of UGN-301 is ongoing and provides an opportunity to broaden our technology application with expansion into immuno-oncology and inclusion of locally delivered immunotherapies targeting high-grade urologic cancers. Mark will provide a further update on our clinical portfolio shortly. Based on our current revenue projections and financial models, we believe we have the tools to reach cash flow breakeven by 2025. This is based on our confidence in our ability to achieve our guided full-year 2022 Gemida product revenues in the range of $70 to $80 million, as well as access to an additional $25 million from the up to $100 million term loan facility with funds managed by Formicon advisors. We recognize that the capital markets are challenging for many companies in need of capital right now. However, we do not foresee a near-term need to raise additional cash. Don will share our updated operating expense projections, reflecting a slight decrease in our full-year guidance from last quarter's projections. While there are additional studies and business development opportunities we are considering, We continue to weigh these opportunities against our goal of reaching profitability. With that, I'll turn the call over to Mark to discuss our recent clinical development update. Mark?

Thank you, Liz. As Liz described, both our Phase III Envision trial with UGN-102 and our Phase I trial with UGN-301 are pressing forward, full steam, on time, and on budget. Envision is a single-arm, international, multi-center study evaluating the efficacy and safety of UGM-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. There are no approved primary non-surgical therapies for the approximately 80,000 patients suffering from this disease each year in the U.S. alone, and it's worth restating that the current standard of care for low-grade disease is endoscopic surgical resection, which is performed repeatedly in the majority of patients due to tumor recurrence. We expect to enroll approximately 220 patients across 90 clinical sites who will receive six once-weekly intravesical installations of UGM-102. The primary endpoint will evaluate the complete response rate at three months after first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve a complete response at the three-month assessment. As previously stated, we remain confident in the design of the Envision trial and the clinical potential of UGN-102 for several reasons. First, Envision shares a similar design to our previously completed Phase 2b Optima 2 study, which enrolled patients with new and recurrent low-grade intermediate risk non-muscle invasive bladder cancer. And where we observed a complete response rate of 65%, and in this subset of patients, Duration of response of 12 months from the start of therapy estimated by Kaplan-Meier analysis to be 72.5%. I'd like to take a moment to draw everyone's attention to an additional piece of information that has recently come to light in the wake of our Phase IIbOptimacure trial. Investigators at the University of North Carolina recently published an article in the Journal of Urology detailing the patient experience of participants in the UGN-102 phase 2b trial on which the envisioned study is modeled. Participants in this research program were evaluated by questionnaire and a subset by detailed interviews. Several interesting points emerged. First, patients reported few side effects following treatment with UGN-102. Second, many interviewed participants preferred chemoablative treatment to the standard of care with which all had prior experience. Most would recommend UGN-102 to other patients considering treatment for non-invasive bladder cancer. While preliminary, these results are encouraging and further support the contention that a non-surgical office-based approach to the management of recurrent NMIBC could be valuable to patients. I will reiterate Liz's guidance that we aim to complete enrollment of the Envision trial by the end of 2022, assuming positive data. and plan for an NDA submission in 2024. While Envision remains our top priority for UGN-102, we also continue to advance a single-arm at-home installation feasibility study for UGN-102 described previously, which we also anticipate completing this year. Meanwhile, our Phase 1 trial with UGN-301 initiated in April is actively enrolling and on track for first-arm completion within 12 months. You'll recall UGN301 is our in-licensed anti-CTLA-4 antibody for intravesicle administration via RT gel in development for the use in combination with other immunomodulators, including UGN201, our proprietary TLR7 agonist, and other potential chemotherapy and immunotherapies to treat high-grade non-muscle nasobladder cancer. This study will also seek to determine a suitable dose for a subsequent Phase II trial. It's worth reiterating that this study will utilize a novel master protocol design that we believe will provide a more efficiently streamlined development program since it allows for evaluation of multiple combinations in parallel. We ultimately view UGM301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade non-muscle invasive bladder cancer. More broadly and beyond just UGM301, We see intravascular administration immunotherapies with our RT-gel technology as an opportunity to explore a variety of novel immunomodulatory drug combinations with potential to advance care across multiple clinical indications in urology and specialty cancers. And with that, I'd like to turn the call over to Jeff to provide a commercial update. Jeff?

Thank you, Mark. As Liz noted, gel mito sales continue to grow at 16.6 million in Q2. representing a 22% increase from Q1 and a 28% increase from the same period last year. Our previous net product revenue guidance for Joe Mito of 70 to 80 million for the fiscal year remains unchanged. Our launch ramp strengthens as the environment continues to normalize. Activated sites on August 1st were 893 compared to 857 on May 1st, 2022. While repeat accounts on August 1st were 144, compared to 114 on May 1st, 2022. Another important metric we track for gel mito's adoption is nephrostomy tube administration. Based on the feedback from our field force of regional business directors, our nurses, and our territory business managers, we believe nephrostomy administration has increased from approximately 20% to approximately 40% of installations over the past three months. This positive encouraging trend confers multiple potential benefits, including offering physicians and patients multiple modes of administration, more flexibility in scheduling, and minimizing manipulation of the ureter during installation. In addition, nephrostomy installation may be performed by trained nursing professionals under clean rather than sterile conditions and does not require fluoroscopy after a nephrostogram to confirm placement at the first installation. Additionally, a retrospective pooled analysis by four premier academic institutions of real-world data of 26 patients who received gel mito via nephrostomy was presented at the recent American Urological Association meeting by Dr. Kyle Rose. This analysis described how 13 of 26 patients examined exhibited a complete response, while another 12 patients had a partial response. Nine patients went on to receive at least one dose of maintenance therapy. Importantly, ureteral stenosis occurred in four or 15% of patients. There were no severe adverse events reported, and no patients had impaired renal function. While our existing and prospective business with Jelmido continues to strengthen, we also cannot ignore the opportunity in hand with UGN-102. The U.S. market opportunity in low-grade intermediate risk non-muscle invasive bladder cancer is estimated at 3 billion, and this considers the aforementioned 75% or 60,000 patients that encounter recurrence. 68% of those encounter more than two recurrences, and 23% have more than five. In addition, repeat TURBT procedures have been found to be associated with increased mortality of 14%, independent of surgical risk. And preliminary market research shows that physicians identify 25% of these patients as ineligible or averse to surgery anyhow. With the relevant ease of administration of UGN-102 and the potential to limit or avoid TURBT, it should come as no surprise that 96% of urologists surveyed indicated they would adopt UGN-102 into their treatment protocol within two years of approval. With that, I'm happy to pass the call over to Don to discuss our financials. Don?

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 second quarter ended June 30, 2022. Eurogen recorded net product sales of Jeremiah for the second quarter of 2022 of approximately $16.6 million. This compares to $30 million in the second quarter of 2021. We continue to anticipate the full year 2022 net product revenue from Jeremiah between $70 and $80 million. Cost of revenues for the second quarter of 2022 was approximately $1.8 million, resulting in a gross margin of 89% compared to a gross margin of 89% in the second quarter of 2021. Research and development expenses for the second quarter ended June 30, 2022 were $12.6 million compared to $12.1 million for the same period in 2021. R&D expenses included $0.7 million and $1.0 million in non-cash, share-based compensation expense for the second quarter of 2022 and 2021, respectively. The increase in R&D expense is related to the ongoing Phase III InVision study of UGN-102, offset by lower expenses for the Phase I study of UGN-301 as compared to preclinical work in the prior year. Selling general and administrative expenses for the second quarter ended June 30, 2022, worth $20.8 million, compared to $22.3 million for the second quarter of 2021. SG&A expense includes $2.2 million and $5.0 million of non-cash share-based compensation expense for the second quarter of 2022 and 2021, respectively. The reduction in SG&A expense resulted primarily from a decrease in compensation expense, offset by expenses related to participation in the 2022 American Urological Association Annual Meeting. For the second quarter ended June 30, 2022, we reported financing expense related to prepaid forward obligation to RTW investment of $5.8 million, compared to $3.1 million for the same period in 2021. Interest expense related to the up to $100 million term loan facility with funds managed by Pharmacon advisors was $2.2 million for the second quarter of 2022. As the transaction closed in March of 2022, there was no such expense in the second quarter of 2021. When the second quarter ended June 30, 2022, we reported a net loss of $26.7 million, or $1.18 per share. This compares to net loss of $26.2 million, or $1.17 per share in the second quarter of 2021. The net loss for the second quarter of 2022 includes $2.9 million in non-cash share-based compensation expense compared to $6.0 million in non-cash share-based compensation expense in the second quarter of 2021. We closed the quarter with $112.4 million in cash, cash equivalents, and marketable securities. During the second quarter, we took additional steps to further strengthen our balance sheet in support of our commercial and clinical development activities. As Liz mentioned, we are acutely aware of the challenging capital market environment and take comfort in our routine, diligent, and responsible management of our operating capital to ensure our core assets are prioritized and needs are more than met. We believe the closing of the up to $100 million term loan facility with the funds managed by Pharmacon Advisors in March has positioned us well to weather this challenging capital market environment. As a reminder, a second trench of $25 million of the total $100 million term loan remains available to us, if drawn upon before the end of the year, subject to customary bring-down conditions. As previously mentioned, we continue to anticipate full-year 2022 net product revenues from Jelmido to be in the range of $70 to $80 million, representing a 46% to 67% increase over 2021. We lowered our anticipated a full year 2022 operating expense guidance to stand in the range of 130 to $140 million including non-cash share-based compensation expenses of $10 to $60 million, subject to market conditions, and we anticipate the full year 2022 non-cash financing expense related to the prepaid forward obligation to RTW investment in the range of $22 to $26 million, of which an estimated $9.1 million to $10.4 million will be paid in cash. So in closing, With our fortified financial footing, we remain focused on commercial growth and execution in the clinic. When coupled with our adjusted full-year OPEX guidance and ongoing efforts to prudently manage our cash burn, we anticipate ending the year with approximately $100 million in cash. And based on our current revenue projections and financial models, we believe that our current financial position and the tools available to us provide us sufficient runway to achieve cash flow break-even by 2025. Overall, our balance sheet is strong, our income statement is continuing to strengthen, and our cash flow is well in hand. With that, I'd like to turn the call back to Liz for closing remarks.

Thank you, Don. I'd simply like to close by expressing my pride in all that we have accomplished and continue to execute on from the entire URGEN team. We are in close contact with stakeholders that utilize and receive Gelmido as well as those participating in our clinical trials and are thrilled with the feedback we continuously receive for advancing these innovative and novel treatments. Our progress would not be possible without them and want to send our sincere thanks for their participation. We recognize the challenging environment and want to thank and reiterate our commitment to our shareholders, who recognize the long-term vision and strategy and remain bullish on our ability to build a meaningful, long-term, sustainable growth business. I'll now turn the call over to the operator for a Q&A session. Operator?

Thank you. To ask a question, you will need to press star 1-1 on your telephone. Once again, that's star 1-1. When they stand by, we'll compile the Q&A roster. Our first question comes from the line of Chris Howerton from Jefferies. Your line is open.

Excellent. Thank you so much for taking the questions and congratulations to the team on the great quarter. So I guess two questions for me. One is kind of a, I guess, more of a complex question. I hosted a call with a physician recently from Boston at a larger institution, and I would like you to be able to maybe comment on two potential drivers of growth for gelmito that came out of that call. One was the the time it took larger institutions to really onboard the process efficiently. From my conversation, it seemed like it took their institution, you know, at least 12 months to kind of get fully on board. So how might we expect the impact of those larger institutions with potentially multiple patients available for gel mito in the coming quarters? And then the second one, which you've already addressed on the call, which was awesome, which was the nephrostomy administration. I think on one hand, you can see the ease of administration, but in his hands was not the preferred methodology. So I guess How are you kind of seeing the receptivity to that route of administration moving forward? Is it going to be spotty like that? Is it education that it's going to take to continue that adoption? The second question that I have would be just a clarification in terms of the expected timelines for the data readout for 102. You know, should that be, is it, I think it's just a one-year endpoint, so is that kind of the timeline we should be thinking about? Thank you.

Hi there, Chris. This is Liz. First of all, I actually want to thank you for doing, hosting that call. It was very informative for us, and if anyone on the line didn't get to hear it, I would recommend, I'm not sure if you have a playback of it, but I definitely recommend listening to it. It was great. I'll just turn it over to Jeff to answer the first two questions on the time and the nephrostomy tube, and then Mark can answer the timing question. Thanks.

Hey, Chris. I appreciate the interview as well. I thought he actually did it in less than 12 months. They were one of the ones that were able to do it in six months. It's a range. It depends on the account. It depends on the speed at which the champion can get it on formulary. Get it through pharmacy as well because it does have to be mixed with these accounts. So those are probably two good numbers. In your hospital accounts where there is more bureaucracy and there's more of a formal process, it could take anywhere from four to 12 months. And as you saw with the number of accounts activated, we've still got accounts to activate as we get closer to peak, and we're going to continue to grow that. But I think I'm comfortable saying the faster ones can move four to 12 months, or four months, and usually sometimes it can take longer than that. And nephrostomy, I think it's going to continue to grow as we generate more data. I was pleasantly surprised with the data that we have out there, which is good, but it's not a significant number of patients I think it's going to continue to go up as we get a greater number of patients and we're able to go out there with more data. Having said that, to answer your question, I do think it's going to ultimately be physician preference. You know, you have physicians that would prefer to deliver at retrograde, and they still may, but we've also heard from a lot of physicians that prefer to deliver at retrograde a year and a half ago, and they're delivering it now through an afrostomy tube.

Can I maybe ask, I'm sorry, Mark, I just wanted to ask maybe just a very quick clarification to Jeff is the, you know, could you estimate the kind of number of physicians that have tried to use the nephrostomy tube route at this point?

I think the range would be too great. I can certainly look into that. but now I can't even estimate, because it really has just been this last quarter. So I don't have that level.

Yeah, I think just to sort of comment on that, as Jeff said, not everyone will move to nephrostomy tube, right? You have those physicians who are very comfortable with the current approach, and they'll continue to do that. But those that will, and actually you have some patients, frankly, Because we've talked to patients as well who also don't want to use nephrostomy tubes. So having, as Jeff commented, I think having both available and the utilization of nephrostomy tube and getting more data on that has been very helpful. And I think that will continue to be. But I don't think that you'll ever be in a situation where all of them will move. Mark, I don't know if you feel differently, but you can comment on that before you move to the question on the clinical timing.

I think that's exactly correct, and the great thing here is there are two modes of administration, and physicians and patients will avail themselves of whatever they're most comfortable with, so it provides a lot of meaningful flexibility in the real world, which is terrific, and it's exactly how we take care of patients. It makes a lot of sense, and as has been said, patients and physicians will make their own decisions, but it does provide a nice option if nephrostomy tube is available. With respect to timing on Envision, let me just remind you, we're gonna enroll that this year. Everybody needs 12-month follow-up. That's what we'll spend 23 doing, is getting all that 12-month follow-up, so the data will be in in 24 for our submission to the FDA. However, as you all recall, We also are accumulating data from the ATLAS trial, and those data will be available in 23, and we expect to share some of those data then.

Okay. I really appreciate you taking the questions. Thank you. And we do have a replay, I think, of that call.

Oh, good. Great. Thanks, Chris.

Thank you. One moment for our next question. Our next question comes from . Your line is open.

Thanks so much for taking my questions. Just a couple. I was wondering whether you have a real degree of visibility at this point regarding where steady state sort of utilization rate penetration would be for the nephrostomy tube-based delivery of gel mito. My understanding is, you know, right now it's running at around 40%, but do you think ultimately it's going to wind up being the vast majority of the situations in which Jelmido is administered? And then secondly, I was wondering if you could comment on, in the context of your full-year revenue guidance, what you expect to be the principal accelerators of revenue growth in the second half of this year. Thank you.

Yes, sure. So thanks, Ram. I think it depends on the larger retrospective data that will come hopefully soon. And it depends on what that reads out. To answer your question, I'll give you a big range. I think it's going to be the majority. But it's probably going to be between 50% and 70%, I believe, will be nephroxomy tube, depending a lot around that data. And I would have never expected it to be this high this early. a lot around that data. And I would have never expected it to be this high this early with really very little data. And the fact that it's been going up every quarter, it doubled from Q1 to Q2, I could see this being as high as 70, 75% of the installations. And as far as guidance, I do think it's going to be the retrospective data that the timing of that that can help 75% of the installations. And as far as guidance, I do think it's going to be the retrospective data, the timing of that, that can help excel our end of year Q3, Q4 growth. We continue to implement more and more patient marketing, so patient awareness. We believe this is a big driver that can help us towards the end of this year and into next year. So if patients are aware of they're asking, they're discussing with their physicians if this can help as well. So those would be the two things from my end.

Yeah, I think the only thing I'll add to that is we continue to see an increase in our patient enrollment forms and patient demand. And I think when you look at that and project it out, of course, as we've talked about before, weeks are volatile, so you can't look just at patient enrollment forms because we also are starting to see more stocking and more purchases, more bulk purchases, particularly by the institutions. And as was mentioned in the first question that Chris said, we also are seeing some new institutions come on board and have just actually gotten approval for some of the larger institutions around the country. So I think as you continue to see that, you continue to see the new institutions coming on board, you continue to see nephrostomy tube usage, particularly in the community practices, so they don't have to worry about, you know, fluoroscopy or anything else. I think those are the things that will help us to see an inflection point as we get into the rest of Q3 and Q4.

Thank you very much.

Thanks, Ram.

Thank you. One more for our next question. Our next question comes from the line of Boris Peeker from Callen. Your line is open.

Great. My first question is if we look a little further on Joe Mito projections, just based on your internal market estimates, what percentage of the target market has Joe Mito already penetrated?

Yeah, we haven't provided that particularly, but it's, you know, between 10 and 20%, and we still, you know, have obviously a long way to go there. So, you know, it really depends. I think one of the biggest things that we continue to face is finding the patients, right, because they're not linear, right? So, you don't get every month, you know, there's different patients that get identified and different levels of patients. So, it's hard to sort of say what your exact penetration is at any point in time. You have to look at it over time. But if you think about what we've talked about before, which is, you know, the entire market is $700 million. If you think about the $70 million this year, you know, what penetration would be obviously would be, it's bigger than 10% because 10% would be for the full year. So as you start to get into the second half of the year, you're getting closer to that sort of 15% to 20%.

Got it. And of these patients that are available in general, do you have a sense of the breakdown between large medical facilities, which may take a long time to onboard, versus the more community setting?

Yes. Jeff, you want to talk about that?

Sure. So it still continues to be about 50-50. We've got a, for community doctors who don't want to do this, we've put in the last six months a robust referral program to get those patients to folks that do. And there are. There are some smaller groups that don't want to, they either don't treat UTUC or they don't want to be part of the buy and bill financial burden. And so we connect them with physicians, colleagues in their area that are administering. And we will continue to do that. That will be a critical success factor because there are a lot of urologists that may not just want to to treat these patients, and we need to get those to urologists that will provide gel mito as an option. So 50-50 to answer your question.

Great. Thank you very much for taking my questions.

Thanks, Boris.

Thank you. One moment for our next question. Our next question will come from Matt Kaplan from Lattenburg. Your line is open.

Hi. Good morning, guys. Congrats on the second quarter results. Just wanted to dig in just a little bit more to the nephrostomy tube application. I guess maybe a question for Mark. If the data, future data, looks comparable to retrograde perfusion, what would be the reason why doctors or patients would prefer the retrograde perfusion? Is there some economic advantage or incentive to doctors to use the retrograde versus the nephrostomy tube?

I'll take the economic.

Thanks, Matt. From a medical perspective, it looks like the argument, and this is based on very preliminary data, the argument that people are going to be able to make is that there may be less ureteral manipulation with nephrostomy And as everybody recalls, at least in the Olympus trial, narrowing of the ureter, albeit transient in most patients, was a concern. That seems to be less of an issue with nephrostomy administration. However, from a medical perspective, how you get this gel into the renal pelvis of the ureter is really more a matter of physician preference and comfort. And from a patient perspective, the one thing that argues actually in favor of nephrostomy administration is It can be done very rapidly in the office. And the retrograde administration is a little bit more cumbersome and it requires a little more instrumentation. But let me defer to Jeff on the economics.

Sure. So the community doctor, when they have to go, as you know, Matt, when it's a Part B drug, it's whatever institution or doctor buys the drug that then gets reimbursed. So if the community doctor goes to their surgery center, it's the actual surgery center that that purchases the drug and the surgery center is reimbursed. If they go to the hospital, it's the same. The hospital purchases, the hospital is reimbursed. The advantage here is they can deliver this in the clinic. So it's the actual office that will buy the drug, similar to other drugs like Provenge and Zofigo that are given in the clinic. This is now sort of changed an economics from a doctor who's been going to the surgery center or been going to the hospital, they now have the ability to buy the product and then they get reimbursed, their group of three or four or their clinic.

Okay, that's helpful. Great. And then a question on 102 and the Envision study. What's the rate limiting step to the filing of the NDA at this point? And I guess what I'm getting at is where are you on manufacturing and where is that process?

Yeah, I mean, we're on schedule. That's not the rate limiting factor. Everything's great from manufacturing, our CMC, all of that. What really the rate limiting factor is you have 12 months of follow-up, right? You need 12 months of follow-up, a minimum 12 months of follow-up, and we will continue to follow the patients even beyond that So really, as I've said before, unfortunately, I can't make 12 months go faster than 12 months is. And so assuming we're on track right now for our enrollment, happy to say through July, and it looks like we'll be that way through August. So we're happy with where we are with enrollment. So we expect, as we said, that will be done by the end of the year. And then you have to take those paces to 12 months. So we're saying it'd be the end of 23. So then it becomes database lock and cleaning, which obviously, as you know, takes time. We have to make sure we don't want to do anything that would jeopardize the quality of the data. So it's all about the data and the timing on the follow-up. But we will continuously be talking to the FDA as we get a little bit closer to that and see what our possibilities are for different types of submissions. So as soon as we have that, obviously, we'll share it. But that is the only rate limiting factor for us.

Okay, great. Thanks for that detail, guys.

Yeah, thanks. Thanks, Matt.

Thank you. One more for our next question. Our next question comes from Leland Gershel from Oppenheimer. Your line is open.

Good morning. Thanks for taking my questions. Just a couple for me also on the nephrostomy tube central grade installation. Clearly, it seems to be catalyzing interest amongst physicians despite the limited data. In our discussion with urologists, it seems like they're finding the time-saving of patients coming in for the repeat weekly installations with the tube to be simply much better than the much longer time involved in terms of having to prep patients and the other aspects related to the retrograde which may potentially make up for or outweigh any economic financial benefits to those same positions. I'm wondering, Jeff, if you can kind of comment around that dynamic. And also, with the doubling of the installation rate on the antragrade, I just want to drill into that a bit more. Is this coming from docs who are becoming more comfortable and therefore treating more of their own patients? Is it driving an expansion and broadening of urologists perhaps to those in groups who may have been either slower or more reluctant to adopt Delmido? How should we think about kind of the landscape of urologist adoption across the different types of urologists out there, community versus referral center and so forth, with antiregrade becoming a viable option? Thank you.

So the first question, the biggest piece of feedback I get is they don't have to schedule OR time. They don't have to schedule surgery center time. It just allows them a lot more freedom from a treatment standpoint. It allows the patient to go to a comfortable environment. And so there's a convenience on both ends. But I think the biggest, the one that I've heard the most is just the scheduling, which can be challenging given the staffing issues that we're seeing in hospitals and surgery centers. So that's probably the biggest driver that what I've heard. As far as the doubling, I think it's probably a combination of a lot of things. I think now you see physicians that enjoyed the ease of this in their clinic and start to see and start to realize that this is an option that they may expand to greater parts of our indication. Perhaps they were using it in some areas and now they're using it in the full indication because they're able to do this in a more convenient manner. I would say that's probably more the dominant than versus like new physicians that weren't as interested in gel mito and now they're very interested from a nephrostomy tube. I think there are some that have shown interest now that we have shown data from this level of administration. But it's really primarily around the ease of convenience. Even though we did overcome all the challenges around the training, the mixing, the setting things up, sometimes it's not really what we can do. It's the institution. It's the scheduling. It's when can I get into OR. It's the days I'm in OR. This provides a much greater convenience for everyone. Great. Thanks very much.

Thanks, Leland.

Thank you. One more for our next question. Our next question comes from Paul Choi from Goldman Sachs. Your line is open.

Hi. Good morning, everyone. Thanks for taking our questions. This is Charlie on for Paul. Just a quick one from us. I was curious about the operation expense guidance reduction for the year at this point. I'm just wondering, is there any particular business strategy or philosophy behind where those cost cuts were made and just anything that you're looking to prioritize or anything? Any color there would be great. Thank you.

Yeah, sure. You know, really what it came down to, just some of our expenses just came in lower than we expected, right? So, you know, some of the, particularly around the clinical studies and some of the work. So, and I'll ask Dawn to comment further. I think that some of the other stuff was, you know, like we had a, we'd like to do a study in the unwilling and unable, right? It's something that the FDA has not agreed that they would give us an approval on, but it's something that we believe If we had a study that showed those patients unwilling or unable to go through surgery, that that could broaden the patient population. So we decided as a company to delay that, started that study into next year. One, we don't want to do anything with this is for UGM-102 until we have finished our current Envision study. So we decided to postpone that. And I think the other stuff is really just really around the margin. But Don, do you want to comment about that?

I mean, you mentioned everything to cover. So yeah, so that's it. And we don't really want, we want to keep our JMIRO and one of the focus and 301 as well. But anything, Good to have. We're trying to reconsider, but, you know, basically we've covered everything.

Yeah, let me just make one other comment. I just want to say we haven't cut anything that would help with the adoption of gel mito. That is one area that we absolutely are making sure that anything, any areas, particularly Jeff mentioned earlier around patient activation, we really believe that to, you know, to get a sense of urgency from physicians that patient activation is a key strategy for us going forward. So we're not doing, we're not cutting back on any of our commercial spending, but, you know, we're just being very diligent on everything that we're doing.

Got it. I appreciate the color. Thank you all so much.

Thank you.

Thank you. And I'm not showing any further questions in the queue at this moment.

Okay, great. Well, You know, as I mentioned before, we're very proud of the progress that we continue to make toward realizing our vision for those patients suffering from urothelial cancers. We appreciate your continued support. This concludes today's conference call. Thank you for participating. We look forward to keeping you all informed as key events come to fruition. So thanks, everyone. Operator, you may now disconnect.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.