CG Oncology, Inc. (CGON) Earnings Call Transcript & Summary

Good morning, everyone. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the Senior Biotech Analysts here at the firm. On stage, we have CG Oncology. I will now pass the mic to their CEO, Arthur Kuan for a short presentation followed by a live audience Q&A. Arthur, welcome. The stage is yours.

Thank you, Brian. Good morning, everyone. So at CG Oncology, we're laser-focused on one mission, and that is we're developing a bladder-sparing therapeutic for patients afflicted with bladder cancer. And to do that, we've deployed a very focused strategy to address what we believe to be 150,000 patient per year market in the United States. So as you can see here, the incidence of bladder cancer in the U.S. is about 85,000 patients a year. And the prevalence is a number that's over 700,000 patients. 75% of those patients are non-muscle invasive. And the hallmark of this disease is that recurrences are very often and oftentimes it leads to progression and ultimately metastatic disease. So our strategy is to focus on the non-muscle invasive bladder cancer segment. And within that, we've double-clicked into the intermediate risk as well as the high-risk population. So you can see we've invested in across the board in IR as well as HR. And in it, we have 2 pivotal Phase III trials, one that's about to read out in the next first half of this year. And then our BOND-003 trial, which is a Phase III monotherapy single-arm pivotal trial, that's already read out, and we're providing additional updates. That program is currently under a BLA process, which we'll provide more updates on. But as you can see, this strategy leads to what we believe is a stepwise pathway towards our TAM expansion. Starting on the very left-hand side, we're looking at 25,000 patients in our initial addressable market in the BCG unresponsive segment. And first half of this year, we expect to report data from the PIVOT-006 trial. That will then add another 50,000 patients to our TAM. Also in the first half of this year in CORE-008 Cohort CX, this is a combination cohort of creto plus gemcitabine. That data is expected to come out in the first half of this year in the BCG-exposed opportunity. These are some near-term expansion opportunities that we believe to be low-hanging fruits for us. So just a quick review of what we accomplished in 2025. We were able to execute on all these key data sets that also led to the initiation of our BLA filing. Our PIVOT-006 trial, which is our intermediate risk trial was also completed. We enrolled that trial nearly 9 months ahead of schedule. Looking ahead to 2026, I'll just highlight a few key areas for focus -- for investors to focus on. The first one really is we are set to complete the BLA submission for our first BCG unresponsive indication. And from a data catalyst perspective, the first one on the top, CORE-008 Cohort CX, this is in the BCG-exposed category. We expect to read out the first results in this setting in the first half of this year. So we're looking at cretostimogene plus gemcitabine in combination. And moving to the bottom here, we've also announced last week that the first -- in the first half of this year, we'll be reporting the top line data in PIVOT-006. So this is a very exciting opportunity. And with that, we're also guiding that we'll complete the BLA submission for the intermediate risk population in 2027. So just to go over the patient journey for bladder cancer patients, specifically in non-muscle invasive bladder cancer. As you can see here, when you first get diagnosed, you go through a series of testing and you go through a series of TURBT. And then you go into this every 3- to 6-month cycle of surveillance and treatment. So really, what we're looking at here is a chronic disease that continues to recur. And within NMIBC, there are 3 risk categories, but we're focused on the highest unmet need, which are high risk as well as intermediate risk. Within high risk, you've got BCG as well as other intravesical chemo, radical cystectomy, and there are a couple of FDA-approved agents now. But as you'll see later, our product profile really stands out among all those therapies. In the middle here, I want to point your attention to intermediate risk disease is characterized by multiple recurrences and these patients are really burdened by the amount of TURBTs that they have to go through. So even intravesical BCG, which is not FDA approved, is no longer recommended by guidelines due to the BCG shortage. So we're trying to position creto in this setting as the first-line adjuvant therapy for intermediate risk disease. Speaking about our MOA, we believe this is really the cornerstone to all of the great efficacy and safety data that we're seeing. So creto is an oncolytic immunotherapy. It has a dual mechanism of action. On one hand of the equation, on the left side, it selectively replicates and kills cancer cells. On the right-hand side, upon selective viral lysis it's going to trigger a very potent antitumor immune response. It secrete GM-CSF, which is a transgene that we carry inside creto as well as you're going to see a lot of tumor-associated or tumor-specific antigens that gets released and that then leads to a very powerful priming of the immune system, which we then could show you in our clinical data, we're seeing a very beautiful long tail. And that kind of tail in the response rates can only be seen within immunotherapy. Creto is given intravesically directly into the bladder. And this fits right within the standard practice. It's given the same way as BCG, which is the standard of care. And very importantly, this procedure can be done by a medical assistant without an MD's involvement. Creto is dwelled inside the bladder after we first pretreated with a DDM transduction agent, which removes all the GAG layer that protects the bladder transiently and then we'll give cretostimogene shortly thereafter. So it's a very simple procedure and process, and this really fits right into the current practice. This is the first pivotal trial that we ran. It was -- we reported out results at various time points last year. But very importantly, this trial was designed in accordance with the FDA guidance, which really defined what they mean by BCG unresponsive disease. In a nutshell, you have to fail 5 doses of BCG induction plus 2 doses of maintenance and recur within a 12-month period. So with that, we reported a 75.5% complete response rate in over 110 patients. This is really the largest data set in this population. And if you look at on the right-hand side, these are landmark CR rate analysis. These are complete responses. At 12 months, looking at the observed CR rate, we're sitting at 46.4%. And at 24 months, it's nearly 42%. And you'll notice that at the bottom here, most of the patients did not progress to muscle invasive disease. So at 96.4% progression-free from MIBC, this is really the highest PFS rate that we've seen in this category. Here in this bar graph, you can also see clearly how we rank up against other agents that are approved at a 24-month landmark. So creto on the left-hand side, sitting at 42% really remains the category winner. On the very far right, you have KEYTRUDA, pembrolizumab, despite being an anti-PD-1 immunotherapy, in this setting, really, it's only shown a 9% complete response rate at 2 years. On the right-hand side, I want to point to the second bullet point here. And this is really the long tail that I was speaking to. 90% of patients remain in CR when they have achieved a CR rate at 12 months. So if you have a CR rate at 12 months, there's a 90% chance that you're still going to be in a CR at 2 years. And that is very powerful. And that is a key kind of messaging that we've been telling physicians, and that's resonated really well. And on the bottom right here, this is also a very unique feature with our oncolytic immunotherapy where you've not seen any grade 3 side effects that's of significance. And this is one of the key differentiations that we have over chemotherapeutic approaches. Now in the TAT1 subset of patients, these are papillary lesions that are resected by surgery, and then we're giving creto as an adjuvant therapy. So we're looking for the prevention of future recurrences. Even in this setting, we're seeing that out to 9 months, we're still sitting at about 80% event-free survival rate. And that really compares quite favorably to the other agents that have already been approved. And 2 of them that have made it on to NCCN guidelines are sitting around about a 50% RFS at 12 months. And since our results are at 80% at 9 months, we think we're still trending in the right direction. Moving ahead, this pivotal trial called PIVOT-006 is being studied in a Phase III trial in over 364 patients, 1:1 randomized. One arm receives TURBT plus cretostimogene. The other arm received TURBT plus surveillance, and we're looking at RFS as a primary endpoint. And so this is the study that we designed in accordance with the AUA-SUO guidelines that includes the broadest range of patients within the intermediate risk category. And of note, again, this is an adjuvant trial, which really fits right into the standard of care. Here's a chart that may help folks understand how we're positioned in the intermediate risk market. Certainly, there is an approved agent, but it's in the chemoablative setting. We're very much positioned in the adjuvant setting, right? So that's one point of differentiation. And even within the adjuvant setting, you can see that we're covering the entire spectrum of IR patients, including the high-grade TA lesions that are less than 3 CM that are solitary. This is something that our competitors have not included in their design, but this is a very important category of patients that we believe could be up to 30% of the IR population. So when you take a look at the entire pie, that opportunity set is likely a 50,000 per year opportunity for CG. Moving on, so CORE-008 is a multi-cohort study. Here on this slide, I'm talking about the Cohort CX, which is a combination cohort of creto plus gemcitabine. And we're focused on this population called the BCG-exposed population. Essentially, these are patients who are neither BCG naive nor unresponsive. This is sort of this in-between patient population that is growing, right? So there's a very large prevalence of these patients out there that unfortunately don't fit inside the tight and stringent FDA definition of BCG unresponsive disease. So with this design, we're trying to design a trial where we're adding gemcitabine on top of creto in 2 different schedules. One is concurrent, one is sequential, and we'll be looking at high-grade EFS as a primary endpoint, including both CIS patients as well as TAT1 patients. These are the other 2 cohorts for CORE-008. One of the cohorts, Cohort A is in the BCG-naive population, and we're looking at complete response rates in that setting. We've shown some results last year at SUO. So this was done in about 49 patients. And the initial overall complete response rate was 83.7%. These are BCG-naive CIS patients. And if you can look at the right-hand side, the primary objective of this study was to actually test 2 different administration schedules of cretostimogene, right? So in the original 5-step administration, we saw a 79.2% response rate. In the optimized administration, we saw an 88% complete response rate. Of note, again, it's very consistent. The safety, 0% Grade 3 AEs, no treatment-related discontinuations have been very consistent with what we've seen before with our other trials. And just to double-click into what we mean by treatment optimization in terms of dosing. From a 5-step process, we've then trimmed down some of the washes that were necessary to make it very simple and streamlined for the prescribers. So all we're doing right now is DDM dwell followed by creto dwell. So this saves about 25% of the time or about 15 to 25 minutes for the site and really just creates a more seamless experience, especially for high-volume BCG centers that see a lot of these patients. That time savings could really help them a lot. This slide, we're trying to highlight the importance of what an HCP would consider kind of their key criteria for prescribing and treating the BCG unresponsive NMIBC population. And this was done in 100 U.S. HCPs, a mix of academic as well as [indiscernible] community centers. And really, the #1 thing that they look for is duration of response, which really means can this drug work for me and how long would it last, right? So you can see at the top 2 is provide CR, provides DOR, efficacy, right? These patients are thinking about should they remove their bladders. So the first thing they care about is will it work for me, right? So it makes sense that this is one of the most important criteria. And of course, safety and tolerability comes next because these patients have a median age of about 72, sometimes in their 80s, and they really do care about side effects quite a bit. They still have a very good life, and they do want to have a great quality of life as they consider these therapies. And the fourth one here, which is equally important, ultimately, the goal here is to prevent radical cystectomy. So as you can see here, this is also ranked very high in our own survey. So from a launch perspective, we're currently in the prelaunch mode. And all of this is driven by data. We've been heavily investing into data being a fast follower to this marketplace, we get the luxury of studying what others have done, and we get -- really understand what the key accounts are doing in terms of how they're adopting new therapies, who are the key decision-makers. So from a field organization standpoint, we have already hired our key commercial leaders. And highlighted here is, ultimately, we just need about 75 field force to help us execute the strategy. And the reason is that in our target urology network market, 300 network sites will do about 70% of all volume in terms of BCG as well as TURBT. And so that allows us to run a very lean and capital-efficient model to address this market on our own. And at the bottom here, just to give you a sense of how concentrated this is, just 10 network urology centers do about 10% of nation's volume. So this is really a hyper-concentrated business. And seeing that we have already invested in so many clinical trials across intermediate risk and high risk, we know these key accounts very well. We've been engaging in prelaunch activities. We've been engaging in clinical research so that they could get an early use of cretostimogene, and we're collecting very valuable feedback, right, as we continue to prime the market and get ready for launch. So in summary, I hope I've shown you that cretostimogene has already shown that we have the best-in-disease efficacy in BCG unresponsive CIS cohort as well as the cohort P cohort in the TAT1 population. And we have some early data in BCG naive as well. So in the middle here, just as important is the best-in-disease safety and tolerability, a very important metric when HCPs think about treating these patients. On the right-hand side, just as a reminder, this therapy is granted breakthrough therapy as well as fast track. And currently, from a manufacturing standpoint, we have a capacity up to 50,000 vials a year. And this product can be stored at frozen. So that's a key advantage that we have where we can start to build inventory into the launch. And as I mentioned here, we do anticipate a lot of demand in the future. And so as such, we've been continuously investing in scale up. The goal here, of course, is to try to scale up at least 10x based on what we have here. And last, but not least, at the bottom, you can see we believe all the successes that we're seeing really has to do with the key and unique differentiated MOA that we have, right, this dual MOA that allows for a selective oncolysis direct killing plus a very potent antitumor immune response. So last, but not least, I just want to remind everybody that PIVOT-006 as well as Cohort CX are 2 of the near-term first half catalysts that investors can expect this year. And with that, I'm happy to take any questions.

Let's start the Q&A. For those who are in the audience, if you have any questions, feel free to raise your hand. For those joining us virtually, you can submit questions on the portal. Thanks for joining us. So very exciting development out of the gate in the new year, especially coming from the fact that you pulled forward your intermediate risk readout, the PIVOT-6 data by 9 months ahead of schedule. That's what you said. What really attributed to the acceleration? And maybe we'll start there first.

Yes. I mean I think what attributed to that is really the fast enrollment that we got for the trial at some months throughout 2025 and earlier even into 2024, we were running 30 and 40 patients per month in terms of enrollment. Secondly, really on the back of the clinical data that we were presenting on the podium at various scientific conferences, we saw such a continued interest from the physician investigator community, along with patients as well that wanted to be on this trial as well. So that keen interest is really one of the driving forces in terms of where we are at this stage. Secondly, in terms of our data as well, I would say that really our patients, as Arthur indicated, in the trial are per AUA/SUO guidelines. That's the broadest set of patients within intermediate risk NMIBC. And that's really the patients that really ended up being enrolled in the trial, including patients that are high grade less than 3 centimeters as well. So that's an element of really what the design of the trial was.

Can you remind us if this study is an event-driven end point has an event-driven endpoint. And what is the trigger for the top line?

Yes. This is an event-based trial. And once we reached a number of events, then it will be unblinded and studied.

Okay. With that said, does this acceleration in terms of time line. When you look at that acceleration, does that have any potential color in terms of your expectations of the performance of the control arm versus the active arm? And also, can you just talk about your level of confidence now given that the trial time line pulled forward by 9 months?

Yes. So first of all, I think PIVOT-006 is the first prospectively designed modern and intermediaries trial that is run in the adjuvant setting that includes a TURBT control with active surveillance. We've not seen a modern trial of this size done in recent years. So across all of the IR subtype of patients, right? So that's number one. So with that, we kind of initial -- our initial assumptions was more of a conservative 70% RFS in the control arm. But our recent viewpoints have evolved, and we have looked at the ATLAS trial from a trial done by a competitor. And in that, their control arm sits at about 50% RFS in about 12 to 15 months. So we think that's a good benchmark for us to think about. And in terms of clinical relevance, we would definitely want to achieve at least a 30% relative risk reduction for it to be clinically meaningful. And from a -- we know we've not done a study in the low-grade disease before. However, PIVOT-006 is looking at recurrent as well as newly diagnosed low-grade patients and -- there's also a cohort of patients that have high-grade disease. And cohort P within BOND-3, half of those patients treated were of high-grade disease, right? So high-grade TA disease. So we think there's some potential evidence that creto at least can work in adjuvant population, right? And so we definitely want to -- we look forward to seeing those results and sharing that with the investor community.

And as we think about expectation at top line, how much color can we get in terms of the efficacy profile, the safety profile of creto. I feel that we have a really good understanding of safety so far. So how do we think about just how much we will learn in terms of the efficacy and intermediate risk, which we don't really have a good sense of its performance in that setting.

Yes. Again, because no one really knows how the control arm is going to do in this population in a very precise way. I think I encourage people to think about relative risk reduction versus the control arm. And as I mentioned, 30% relative risk reduction would be clinically relevant.

Any questions from the audience? It will be good to kind of just step back a little bit and just think about the opportunity that you see in intermediate risk. Maybe coming from the lens of just how establish that setting is. And I also kind of want to see what's your take about your physician perception about creto in intermediate risk? Because your first indication is going to be high risk, BCG unresponsive. So how is that -- is there going to be a gap in terms of adoption when the label for intermediate risk gets turned on?

Yes. I mean, maybe I can comment on that question. I think I'll say the following. I think the physician community is really excited about seeing cretostimogene in this subset of patients. In fact, through the end of the trial, when we completed the trial last September, we really were getting calls last minute from investigators wanting to put additional patients onto the trial. The hallmark of this disease, when you think about it is continued recurrence over and over again. That means they're having to be resected over and over again. And that reduction of that opportunity after doing a complete resection followed by cretostimogene treatment, they feel it would make really an improvement in the lives of patients that have this disease and this disease burden that could result in the thinning of the bladder wall and perhaps even all the way to the perforation of the bladder. Some of these patients have undergone 5, 10, 15 TURBT procedures. So really bending of that curve is really one of the outlooks about this disease. Recurrence reduction and really is a hallmark and the goal of therapy in this stage. And we feel like that's a unique opportunity for us to really walk into that market and make a potentially meaningful impact.

And Brian, I'll just -- if I can add that prior to the BCG shortage, this population used to be treated with BCG in an adjuvant fashion. So physicians are very much used to giving an immunotherapy after surgery. So we hope to be the first approved immunotherapy in this category in the adjuvant setting.

And also, I'll just add another color where the high-grade TA patients that we have enrolled in this trial upon recurrence, they tend to become this kind of this high-risk feature, right? So certainly, having an option for those patients before they become high risk is also very valuable.

Turning to the high-risk BCG unresponsive setting. What is the latest progress in your rolling BLA submission -- and I think one interesting update this week is really the PIVOT-6, the time line there. Does that have any impact in terms of how you think about the time line for your first BLA that's in place?

Yes. Very good question, Brian. I would say, obviously, we initiated our submission late last year. We are still in that process -- and we look forward to giving an update as to where we are in that process in the not-too-distant future. In terms of really looking at the PIVOT-6 potential data readout and that in terms of that part of it. From a process perspective, what we are focused on is really to submit a derisked package as much as possible. So we are working and really doubling down our efforts in conducting mock inspections of our CDMO network, actually facility upgrades at our facility that we purchased last summer including quality management systems upgrades as well that we're conducting at that facility. And then retesting again by mock inspections by FDA inspectors that we have hired on to conduct that. We are very well aware of the history within this space, especially within cell and gene therapy being -- CMC being one of the areas of focus and some of the reasons why others have received a CRL in the past. We would really like to file one and done, and that's the approach that we are taking. Also just last Sunday, actually, I just wanted to highlight some of you may have seen the release from the FDA around clinical flexibility, commercial flexibility and process validation flexibility from the agency, and we look forward to having a dialogue with the agency around what that value could be for us in our filing process. Does that have a meaningful value in terms of the approach that we are taking in discussion with the agency on that topic. Then I will go back to the PIVOT-6. PIVOT-6 from an approach perspective, it's going to be filed on the heels of this indication. Therefore, and it is a much bigger opportunity. Hence, the reason that we are taking our time to make sure that we are really filing a derisked package in that space. That's what I would say, anything.

Maybe just on the labeling. Your data set is interestingly differentiating on durability of response. And when you look at further time line that is further out, you differentiate on that, right? That's one of the key point, at least. Is that going to be in the label? And I guess how should we think about the label language. Do you think that your label could somehow have a differentiation there. So that the session when you looked at the label, they say, this is where creto is going to be different compared to other competitors in the space.

Yes. I mean I would comment that we are going to submit a full data package that includes our extended duration of response. What we have seen, and I think we saw it in the package for N-803 that they were able to get their 24-month data into their label, we hope that we will be able to get that information into the label. Secondly, what we have done is actually really highlighted that in our scientific dialogue and exchange with our investigators today and our future commercial customers today. Really, the audience is well aware and within this particular space, including at the patient level about the value of what that duration of response data is the long-term duration of response. And that's been a focus area on differentiating cretostimogene compared to other therapies within the landscape. So I think there are probably 3 key hallmarks from a differentiation perspective. One is number one, does it work? We've addressed that. Number two, how long does it work for me? That's the duration of response. We have the highest duration of response compared to any of the other available approved therapies or those that are in clinical research to date. Number three is safety. What should I expect from a lifestyle perspective? How does this impact me? Really, we have the best-in-disease data in terms of safety as well. So that's really the benchmark upon which we are hopefully to launch cretostimogene into the market.

I believe we have a question from the audience?

Congrats on all the success. It looks like you guys are executing very well. The question I have is, I'm sure you've commented on this in the past -- is you're clearly in a sweet spot for a large pharma company. you're close to approval. You talked about commercialization. Of course, these big companies have big commercialization infrastructure, et cetera. What is your perspective on a strategic transaction. I guess -- and are you committed to staying independent? Or do you have a stated view on that point? It's sort of an obvious issue to think about.

Yes. I think as I've mentioned here, this is a launch that we believe we can execute very well on our own, and we're well funded into the launch. Our cash balance sheet is very strong. We have, as of Q3, $680 million reported and that's runway into first half of 2028 without including any revenue projections in that guidance, right? So we've known these sites, both academic and community over the years, and we have a very deep and intimate relationships with many of them.

In one of your slides, you noted, I think one of the later slide, you noted that you're ramping up 10x, and you also gave guidance on while you also provide detail on the current capacity. How should we think about just your path -- your guiding path toward that 10x goal, at the time of launch, near term, how should we think about the capacity then? And also how aggressive do you need to pursue that 10x given that intermediate risk is a much larger market.

Yes. And the way we think about this is we'll get the first approval in BCG unresponsive. That's an area where the reference pricing has already been well established for us on top of inputs that we'll be considering there, but that will be the first approval. And with that, our current capacity and scale is more than enough to address that market multiple years into that launch. With PIVOT-6 coming on board and the publication of that data there's also potential for guideline inclusion and then, of course, the ultimate label in that setting. Our goal is definitely by the time we have that label and shortly thereafter, we want to be in a position where we could say, "Hey, into that multiple years into that launch, we'll have that scaled up capacity ready to go." But before then, just building inventory, we believe, is sufficient into that launch.

You talk about pricing. There's a -- as a wide range, let's put it that way. Are you surprised by some of your competitors pricing on the high end? And how does that influence your current thinking about where creto can price for high-risk BCG unresponsive?

Yes. I mean I think to the question about that we're surprised about the pricing, I guess, at the latest entrant into the marketplace. Not really, I would say, is the answer. There's a wide range for approved products from $200,000 to $690,000 a year -- and that's for one year's worth of therapy for BCG unresponsive disease. I think the way we view pricing is we view it through probably 5 different areas. One is really around the target product profile what's your efficacy, what's your safety of your product. Third is really what is our expected length of treatment on the product; fourth, around what is the landscape pricing, which I just mentioned, $200,000 to $690,000 and the fifth around access, access at the physician level, meaning their ability to actually purchase the product or what's that access point is going to look like. And again, followed by from a patient perspective, the co-pay elements of it and also from a payer perspective. Those are the variables we're looking at. Obviously, we have the best-in-disease profile when you look at efficacy, when you look at safety, our expected LOT, you can give up to 3 years, which is about 30 doses for high-risk BCG unresponsive disease. And these products are priced per dose because they are J-code Part B products. So that's an element of what we are looking at. So those are the variables in the equation that we're looking at. And the intermediate risk NMIBC area, the dose is 14 doses per year. So that's a little bit of a difference versus over 3 years, so 30 doses for cretostimogene. So those are the variables that we're looking at in our pricing study. The latest entrants into the marketplace establish a new watermark from pricing perspective, and that's going to be part of the equation that we're looking and calculating on.

This is a great slide to just sit on. Maybe just kind of wrap up. Strategically, your to lead indications. When you think about it at a high level, it's really about the book end of NMIBC, right? You have high-risk physician response on this and intermediate risk on this end -- where do the other 2 fall into place, right? I mean they clearly exist. But I remember that there is a conversation with Arthur that BCG exposed is a little bit unclear. Even in the doctor's eyes, so how do you think about where those 2 opportunities are for the creto franchise? And how do you capture that in the long haul?

Sure. I mean, I would say, obviously, just as you said, on the right-hand side is our first indication in BCG unresponsive disease both from a regulatory approval and also from a compendian lease thing for cohort P followed by 50,000 patients in the PIVOT-6 patient category. And now really, there is an increased understanding and interest by clinicians because of a definition that has been set forth by the IBCG Group, the International Bladder Cancer Group around the defined population of BCG exposed. Now we are into 10 years now plus of the shortage of BCG. It has created this patient category in which patients have not received full course of BCG. They have received only induction, half dose of BCG through their course. They're 12 months and a day, but before 24 months in their course of treatment. And this is really this large group of cohort of patients. And we believe there's an opportunity to conduct a randomized trial with a chemo control potentially and that's what we are -- we're going to have the first data and the combination of cretostimogene plus gemcitabine this year and we are going to be following up with the agency and really about creating a potential randomized trial in that subset of patients to access that subset of patients.

Great. Well, thank you so much for being here. I know that is your first time, and great to have you here on stage and see you soon. Thank you.

Thank you again.