Q1 2023 UroGen Pharma Ltd Earnings Call

Speaker 1: Chief Medical Officer, Jeff Goba, 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 Eurogen's product and product candidates to transform the treatment paradigm of urothelial and specialty cancers.

Speaker 1: 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 protect theThanksgivingins starving

Speaker 1: and 2023 financial guidance, among other things.

Speaker 1: 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. Let us check again if these couple recommendations apply.

Speaker 1: You are cautioned not to place undue reliance on these forward-looking statements and your agenda explains any obligation to help keep these statements.

Speaker 1: I will now turn the call over to Liz. Live.

Speaker 2: With the launch of GelMito, 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 tracheal filial 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.

Speaker 2: and low-grade intermediate risk non-muscle invasive bladder cancer, an indication impacting approximately 80,000 patients in the United States each year.

Speaker 2: Turning to the quarter, I'm pleased to announce that first quarter gelmito net revenue 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 gelmito adoption is encouraging, we are further assured to see our guidance model consistent with actual results.

Speaker 2: indicating that the seasonality we've previously observed may be reliably predictable. As the utility and benefits of gelmido 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 .

Meanwhile, as we look ahead, the focus of our development strategy is very much on UGN 102 and its several near-term catalysts. Specifically, we remain on track to provide top-line data from our phase 3 studies of UGN 102 this summer. For InVision, we anticipate providing the primary endpoint of complete response rate for approximately 240 patients who completed this study, while for Atlas, the predecessor to InVision, 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 be a priority review.

complete response rate and duration of response at 12 months of 72.5% 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.

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 a burden with the risk of surgery and anesthesia as the only recourse for disease control.

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? 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 gelmido 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. Data from this study demonstrated no difference in gelmido outcomes at first endoscopic evaluation based on tumor location. Adding to the growing body of real-world evidence supporting broad use of gelmido.

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 hydro nephrosis, which is the buildup of excess fluid in the kidney due to a backup of urine.

The second study was conducted by Dr. Craig Labad and colleagues and highlighted results of a sub-analysis from the same post-commercialization review of gelmito. The study aimed to evaluate efficacy and safety of gelmito when administered following complete endoscopic reception.

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 at 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 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 percent of UQC 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 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 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 to 12 months to 72.5% using a Kaplan-Meier analysis.

UGA-102 also has key similarities with gelmita. 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. UGN 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 in MIBC 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 1 trial with UGN-301, our M-licensed anti-CTLA-4 antibody for intravestible administration using RT-GL technology, continues to enroll. UGN-301 is in development for use in combination with other immunomodulators.

including UGN-201, our proprietary TLR7 agonist, and other potential chemotherapy and 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-301 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.

represented our second strongest quarter for gelmito since launch.

Adoption metrics in the first quarter continue to demonstrate encouraging trends in the new and repeat accounts. Activated sites on May 1, 2023 were 1,009 compared to 983 on March 1, 2023.

and repeat accounts were 235 compared to 214 for the same period.

Reimbursement remains at approximately 99% across all coverage types. During the first quarter, we held our national sales meeting in San Diego, and I'd like to take a moment to share several key takeaways.

First, we recognize our top territory performers who have demonstrated sustainable growth in their accounts.

They have shown that the opportunity for meaningful adoption in low-grade UTUC exists once physicians embrace 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. And I want to alliances play a role in keeping Carbida's biodiversity

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 GelMido 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 gelmito can be a treatment option as a part of a kidney sparing approach to disease management. With the use of gelmito in a multimodal regimen, the

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 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 the SUO as we further develop and expand Gelmyvil and prospectively introduce UGN-102. This

With that, I'll turn 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 first quarter ended March 31, 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 more information on J-Mito, visit J-Mito.com

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 R&D expense related to the phase 1 study for UGN 301.

Selling, general and administrative expenses for the first quarter 2023 were $24.5 million.

This compares to $21.3 million for the same period in 2022. Increase to SGA is primarily due to higher marketing, commercial, information technology and advisory expenses offset by lower market access, medical affairs and stock-based compensation expenses. Logitech® has established a separate administrative work environment.

Eurogen reported 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 a basic and diluted net loss for ordinary share of $1.30 for the first quarter of 2023. As compared to $28.4 million or basic and diluted net loss for ordinary share of $1.25 cents, European exchange rateinctly been

for the same period in 2022.

Turning to forward guidance, we reiterate anticipated full year 2023 net product revenues from Jeremiah to be in the range of $76 to $86 million. We reiterate the full year 2023 operating expenses to be in the range of $135 million in appraisal and

to $145 million including non-cash share-based compensation expense of $6 to $11 million subject to market conditions. The company reader rates anticipated the full year 2023 non-cash financing expense related to the prepaid forward obligation to RTW investment.

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 equivalence 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 research.

If you'd like to ask a question, you'll need to press star 1 1 on your telephone.

Once again, that's star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again.

Please stand by while we compile the Q&A roster.

Our first question comes from the line of Ram Sadevaju of agency Wainwright and Company. Your line is now open. Your line is now open.

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 gelmido.

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.

Yep, thanks, Rob. 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.

Sure, thanks and hi Ron. So the answer 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 is really opened doors to the territory business managers to talk about this.

and bring it into their clinic. So it provides that flexibility to the physician with their patients as to whether or not they want to do it retrograde or antigrade.

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 is thinking gives you an indication.

what doctors will do with this new medication.

Okay, great. And then can you just remind us what timeline you expect the UTRACT Registry Study to be on and when you anticipate the potential publication of data from that study?

I can comment to the timeline. So, we continue to recruit the investigators and get everything taken care of from an standpoint. So that's gonna 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 re-treatment data, maintenance, ureteral only, a lot of things are being looked at and studied in the registry. But from my standpoint, it's really sort of when you get to that meaningful number of patients.

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 we have certain queries and as we feel like there's enough, you know, enough of a, you know, mass to be able to publish. But we'll have an ongoing publication plan around the registry.

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? Oh, yeah, absolutely. Yeah, I mean, definitely by 2024. Yeah, sure. If not earlier, sure. No, absolutely. My thinking is is that you might not know either these drugs.

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 re-treatment. We want to understand, you know, continue to understand how physicians are using it to Mark's point. So as soon as we, we will, as I said, have an ongoing stream of data coming out and to your point will inform, you know, the optimal way to use it in real world.

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 UGN-102 a running start, assuming that the Envisioned Study data is positive and you receive timely regulatory approval? 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 bladder cancer compared to the 6,000 to 7,000 patients with low...

you know, see these patients. So it's not a situation where you're only gonna see one or two of these patients a year. You know, they see them on an ongoing basis and very familiar. And I do absolutely think what you said is that, you know, the usage of gelmito 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 UGM-102, plus taking into consideration that the big difference here is the ease of use of UGM-102. 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 gelmito, 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. Thank you. Thanks. Appreciate it.

Thank you for your questions. We stand by while we compile the Q&A roster.

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

Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open. Your line is now open.

Hi, thanks for taking our questions. This is Roderick for Powell. And so we have a couple of questions. And the first one is what kind of factors in invasions that I do think that it could help the EUGN 102 to incrementally improve upon the 65% CR rate.

Typically, when you move to a larger Phase 3 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 from that standpoint, we're excited to see the data. But Mark, do you have anything to add? Or I'm not sure if I misunderstood the question, Roderick. You understood it the way I did. And I think it's important to work with.

What would probably increase the uptake on the forward based on the feedback from your Salesforce? Jeff? Yes, a short answer. It was hard to ignore all of what we had going at AUA between the two presentations.

The guidelines coming out the product theater, the 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, we should be doing everything to preserve the kidney. Obviously, gelmito was part of those guidelines. So super excited and 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.

Got it. Just to confirm, so your current cash runway is guided into 2024, right? That's correct. Okay, got it. Thank you. Thank you. Thanks, Rodre. Appreciate it.

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

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 GelMito and what that means for the product? Yeah, absolutely. I actually asked Jeff to comment about that and happy to add any commentary at the end. So Jeff.

Sure. So, hi, Matt. We see early on, on the beginning of the year, your typical patient copay resets. And so, January is a PEP buildup, so we're building up patient enrollment forms. Then they get through the donut hole, and then we're seeing a strong...

clinic six 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 Q3 quarter this year over Q3 quarter last year and continue to have that.

that trend, but we do think that the seasonality is as common, is common with Part B drugs, with procedures in general. We do believe we'll continue to see that, particularly in the third quarter.

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

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

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? Thank you.

can you narrow the summer timing for us a little bit more as well? Yeah, I wish I could. It's like I'm always saying I wish the 12 months of follow-up from a vision that I could make those days go away, but we're really sort of held by the time that it takes for the database lock, and it's really around durability.

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

But we will have both of those and, 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 at this point. 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? Yeah, I mean, you know, 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.

to what we saw in the year, what we studied in the phase two trial. And vision 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 UGN-102. So our expectation is that Envision and Atlas should look similar and that the Atlas data is similar.

should give us some indication as to what to expect in the inpatient trial. 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? Mark, you want to comment?

Yeah, sure. So as you know, we've studied in our preclinical models the combination of the anti-C-KLA-4 antibody with the UGN-201, which is our TLR-7 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 I certainly a plausible candidate would be Eugene 201. Liz may want to elaborate further on that.

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

Thank you. Thank you, Matt. 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.

Hey, guys. Ronen here speaking on behalf of the leaving of your show. 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.

Everyone here speaking on behalf of leaving your show. Just one question for me. So for UGN 102, what do you think regulatory authorities are looking for when it comes to efficacy and durability and low-grade MIBC compared to high-grade? And what do you see one or two sitting in the current low-grade MIBC paradigm alongside surgical intervention and current disease management? Thank you. Yeah, Mark, why don't you start?

Sure. So, in terms of what we think the regulators are looking for with respect to our Phase III 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, of both the complete response rate and the durability of that response in complete responders.

There's no number attached to that. And Liz and I have previously said on multiple patients that in line with what we observed in our phase 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 that, you know, 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 elderly populations is a disadvantageous approach. Many think, including those who are urgent.

So we think that there is a real opportunity for primary therapy to replace transretory section in some patients with recurrent disease. That's the group we're studying in the InVision trial. And then in terms of how this compares with high-grade disease, high-grade disease is a totally different animal.

and the benchmarks and hurdles for approval are substantially different because of the nature of the disease. So I'm not really sure, and Liz may want to comment on this, that it's a fair comparison to make with the approach and the population we're studying. 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. So we will be the only ones, and we're the only ones that are anywhere near being in a phase three. 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 gelmito.

The whole idea, and we believe the biggest benefit for these patients, you know, is to have, you know, have UGM-102 instead of having a T or a BT. But just as we're seeing with gelmito, they used 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 about 68% have two or more recurrences and 25%, about a quarter of them have five or more recurrences. So I think it's fair to say that the low hanging fruit are these patients who are already.

Our next question comes from the line of Boris Beaker from TD Cohen. Your line is now open. Your line is now open.

Great. Thanks for squeezing me in. First, on the InVision 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?

Thanks for scooting me in 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? Yeah, Mark you want to comment?

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, 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 became want to elaborate also.

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 an important secondary endpoint. So what we've decided, 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, some patients obviously beyond that. And along with that, we willheal some researchers compliant today to with respect toa love care and the

of data. If that is, we'll talk about them, you know, how quickly can we get patients to have access to this medicine.

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… Absolutely. …more patients in Atlas than in Vision? So if that's the case, what do you think you need to show in Atlas in parallel for the filing? Yeah, I think Atlas, and Mark may want to comment as well…

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 gonna be mostly interested in the safety from that study. Thank you very much for taking my time.

You won't be able to make comparisons. The FDA won't be able to make comparisons because we didn't—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. Great. Thank you very much for taking my questions. Thanks, document masterbook youtube. successfully.

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.

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 gelmito. We feel like we have a lot of 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 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 UGM 102 and excited to see the

Does.