CG Oncology, Inc. ($CGON)

[indiscernible] I'm a senior biotech analyst here at Bank of America covering CG Oncology. And thanks for joining us for the session with CG and for joining the 2026 BofA Healthcare Conference. I'm pleased to be joined by Arthur Kuan, the Chairman and Chief Executive Officer of CG; and Ambaw Bellete, President and Chief Operating Officer. Thanks for being here, guys.

Thank you. Thanks for having us.

Yes. Great. Well, maybe just to tee up the conversation, Arthur, you guys had an update with your 1Q last week. Maybe you can just sort of run through at a high level sort of what was new from that and sort of what investors should be paying attention to over the next few months.

Sure. So as many of you know, we've initiated our rolling BLA submission for our first indication last year. And this year, we're basically committing to complete the BLA submission by the fourth quarter of this year. And this is in the BCG unresponsive high-risk NIBC space. So that's one of the key highlights of narrowing that guidance. And the second update, the guidance remains the same that we anticipate that in the first half of this year, our top line data from the PIVOT -6 trial could potentially be available. We do continue to emphasize that it is an event-based trial. So it's always hard to pinpoint exactly when that will occur. But as of now, we continue to maintain that guidance. And just this -- later this week, we're also very pleased to present data from our Cohort CX trial. This is a trial that studied in credo plus gemcitabine in a combination in BCG exposed as well as BCG unresponsive patients. We have reasons to believe that the combination could potentially be added. And some of the early cut of that data is now available on the abstract. But AUA, we're going to be presenting the full data set of the early initial responses. So for that, I think we can talk more about that later, but I think that's definitely one to look out for. As in the past, we've already shown that [ Credo ] on its own can really have a robust response rate, both in CR as well as duration of response. But now adding on another intravesical agent that urologists are highly familiar with, we think that could potentially have a benefit to kind of shipping paradigm.

Okay. Obviously, a lot going on with the company. and a lot of different subtypes within non-muscle invasive bladder cancer. I guess -- when you think about the PIVOT top line, the cohort CX from [indiscernible], the rolling BLA on track for completion this year. I guess how you sort of manage sequencing of those readouts against the BLA completion? Just thinking if you've got the intermediate risk data in hand, would a strong result here maybe change the way that you approach your submission in the unresponsive setting?

Yes. So as we've shared previously, both of those BLAs will have a lot of shared modules. For example, the manufacturing module will be shared across those 2 BLAs. Our current plan is -- it's still to complete the first BLA before sequentially filing a second BLA on PIVOT 6. And we have also previously stated that we do need to wait for the 12-month response rate for all patients in PIVOT 6 and then there's, of course, the data cleanup and writing up the modules and preparing the package. So as of now, we still anticipate that the PIVOT 6 BLA will be completed in 2027.

Okay. Maybe we can go one by one. Just on the [indiscernible]. This is in the high-risk BCG refractory population. I guess in terms of what's left on the rolling submission and sort of how we pair this with FDA's new CMC flexibility guidance. I think you said in the past that this could maybe affect your sort of time line calculus. I guess where do the remaining gating items sit? Is it sort of on the facility inspection readiness, the CMC package or anything about the clinical data itself?

Sure. So I think it's important to note that because Credo has breakthrough therapy designation, BTD, it does allow us to have more frequent interactions with the agency. I think the press release from the FDA in January suggests that there is this willingness and openness for the FDA to rethink about manufacturing requirements for sponsors in the cell and gene therapy category, right? So that's more of a general kind of broad-based audience. I think in our recent communications with FDA, we basically got the alignment and clarity that's specific and relevant to our program. And with that, we're able to narrow down our BLA completion timing. And you pointed out facility -- facility inspection readiness activities, that continues to be a key focus for us. In this CGT space, there's been a lot of manufacturing-related kind of inspection issues. We're ultra focused on that, especially around the facility that we just acquired last year. that specializes in fill and finish. That's an area that we put a lot of attention to. But now that we have visibility into what is necessary, we believe everything is going on track and according to plan.

Okay. So the alignment with the FDA, would you say -- would you characterize that as kind of in line with your expectations and what you're already kind of working towards? Or were there additional or less obligation from those?

Yes. I can't go into the play by play, but in general, it's an alignment that provided more clarity for us. And so I think it's overall very helpful.

Okay. And maybe when we think about the competitive landscape in the high-risk BCG-unresponsive, your 24-month landmark CR data and kind of the durability piece is best-in-class from what we've seen versus J&J gene and others. I guess -- what do you expect based on the ex label would be the on-label sort of efficacy metrics. I think they had 12 months kind of CR rate there. And -- do you think that would make a competitive label for you? And how would you sort of position that you to be the long-term data that you've acquired from a commercial rollout perspective?

Yes. So last year, when that label became available, referring to the [indiscernible] label, I think at the time of the initiation of a rolling BLA submission, we've already guided that we want to have a differentiated label on what could be a more durable response since we have that benefit given our MOA that could potentially to a longer tail, and we've really shown that. So I think anything beyond that 12-month durability label that [indiscernible] has would be a great upside for us. And I do think that in the commercial setting, that's going to play a role because we have something that the physicians and patients ultimately really care about, right, which is that durability. So that's a key component. Of course, beyond that, I think our strength in our AE profile continues to be a differentiation overall, which we can get into more detail later.

Yes. Yes. Well, maybe we can talk about sort of the the commercial build-out. When does this fall into place? I think you've described in the past maybe 75 field reps could cover 300 urology network sites, which is the majority of the volumes potentially. I guess, how does this sort of compare against what J&J is building out for [indiscernible]? And is there maybe an advantage to having them build out the initial market and having you come in your later?

Yes. I mean it's a good question. I think the way we see it is, we've really tracked all the launches within this space, not just the [indiscernible] launch. And we've really seen where they've hit the mark in terms of physicians and patients where perhaps there's still some questions outstanding. I think them really coming into the marketplace, we've seen how they have rolled out into the marketplace, how they've engaged accounts, which accounts they've engaged, where they're being successful, where they're not being successful? We're taking all of that and actually incorporating it into our launch strategy. Our launch team has been in place really for a while now. And our team of -- our field medical team, for example, has been out there engaging and having scientific dialogue and exchange with our future commercial customers really now 18-plus months now already, and we'll continue to do that. And as we head into the road to launch. The second piece I would say is we also have a team of health system directors that are calling on the network leadership, for example, at those network sites that you mentioned, that are engaged and having dialogue and really doing a lot of account profiling activities and understanding the nuances of really the buying process in itself. So that's what we're learning. Also the buy-and-bill confidence is increasing. We've seen it with every incremental launch that buy-and-build confidence of customers that are ever increasing. That really bodes well when we're coming into that launch into that same similar space. And really from a footprint perspective, setup perspective, we continue to evaluate the data on really what's the optimal go-to-market strategy. And that continues to inform us of what we're seeing out there. And we know who the first movers are as well. Who were the first centers to actually get on board. Those will be the first mover places that we will go after. And also, I think, really identifying the types of patients that are the first initial patients. Are they newly diagnosed? Are there are patients that are being switched from other therapies and so on. What are those types of patients? Because of cretostimogene clinical data and safety profile, we think all of those are potential eligible patients. the first right after BCG. The patient that may have failed R200. The patient that may have failed gem or gem dose, the patient that may have failed pembrolizumab. Those are all patients that will be eligible patients for cretostimogene.

I guess when you think about the targeted rollout, you obviously per label is expected that you'd have to step through BCG. Does that limit for the potential prescribers that you think about regional versus academic? And is there any, I guess, logistical considerations, especially when we think about kind of the exposed population to as a TAM standard?

Yes. I mean I would say the following. I don't think it -- whether it's in large academic setting or in the community setting that, that really is a differentiated approach. And we think there are eligible patients in the community we'll be able to go after in a similar fashion in the academic setting. In fact, some of the first movers were really more in the community setting, just because they don't have the hurdle rate of a formulary, for example. Getting through the various committees at a hospital. Therefore, they tend to be the first movers in new therapies and that would be a target place for us to go after. Mind you also, a lot of them have already gained clinical experience for cretostimogene. For example, in the intermediate risk trial in the cohort CX trial or even in the BOND3 trial or even in our expanded access program trial, we've targeted really the top centers around the country for this deployment just because they see the patients that we're going after for those trials and itself. That by in itself, it really creates an opportunity because there's already a pent-up demand already existing within those centers and facilities and also clinical experience on how to adapt it into their clinical practice and armamentarium of treatment for their patients.

Okay. Great. That makes a lot of sense. And maybe we can just touch on the safety differentiation versus TAR 200 or [indiscernible], which requires repeated cytoscope base instrumentation. It's pretty invasive. We hear about pressure on the bladder from pretzel. How does this sort of translate into a real-world competitive advantage for creto? And I guess how are you aiming that contrast in your physician discussion?

Yes. I mean I think in terms of the physician dialogue and discussion is TAR200 procedure is a cystoscopic procedure that actually patients have to undergo every 3 months. They're having to actually increase the number of cystoscopic examinations they're having to undergo. That's an invasive procedure. So there's the pain from that procedure. There's the actual throughput of the account, the ability to actually do those types of procedures is an important element of the adoption of this type of therapy within the practice versus cretostimogene, which is very similar to the BCG experience they went through. It's interventaly delivered by a nurse or a medical assistant. It is done in a room that doesn't require special equipment. You need a catheter that is placed into the patient's bladder. DDM followed by accrediting for about an hour, 45 minutes to an hour. So it's truly a differentiated procedure versus a interventional procedure that may require a physician to actually administer the procedure, which in many cases it does, especially the removal. So there are 2 aspects of this that you have to consider. So it's not just the placement, but the subsequent removal requires kind of that 2 steps. You're going in, grasping into a patient's bladder that's under local anesthesia, using a grasping device to grasp the old device out of a patient's bladder, pull that out and put a new one in into. So there's times that you're going in and out of that patient's bladder in itself. So that -- and then you need a full kind of a setup, camera system setup and those kinds of things to do it. So the requirement even to conduct the procedure in itself that's an aspect of kind of one of the hurdle rates in terms of that procedure.

Okay. I guess 2 potential points of pushback that I've heard is that with pretzel, the physicians get to bill for the procedure as well versus creto. So that's one. And then the second is around the logistics of getting creto to patients. Is this still sort of a just in time? How do you think about 5 steps versus 2 steps on the initial label?

Sure. Again, good question. So just getting back into the practice economics, that you mentioned earlier. Most of the economics on these products are on the drug side of the equation. Most of really what a practice earns is really the ASP plus 6 or ASP plus 4.3 million depending on the setting of what they would get from their private payers. That's where most of the economics is. In terms of actual admin, the admin side of the picture, when you're looking at total reimbursements or there's admin, there's drug and there's final reimbursement. So that's how reimbursement would work in this particular setting. When you're looking at the admin part, you're looking at about a $100 differential potentially, in many instances. Again, most of the economics is on the drug. TAR200 is $690,000 per year or $69,000 a dose plus 6%. That's where the economics is. It's not on the $100, so we're $150. So that's on that aspect of it. In terms of the actual in practice adoption, so from a process of adoption perspective, we intend to deliver on a just-in-time basis to centers, but there's a lot of flexibility with that. So once you receive the box, you can put it in a normal refrigerator for 4 weeks plus, okay, a normal refrigerator. You can leave it in the box until the patient comes for up to 5 days and then take it out of the box. It takes about 15 to 20 minutes to prep and administered to a patient. So really, it does give you a lot of flexibility. And then the 2-step process, which we've shown data on the 2-step versus 5-step process, we think that, that is going to be the process that's going to be going to be in practice. We aim to have it in our label, but we know that a majority of patients to date have actually undergone the 2-step process versus the 5-step process. For example, all of the patients in Cohort CX, all of the patients in PIVOT-6, all underwent a 2-step process versus a 5-step process. So there's a tremendous amount of body of clinical experience and the adoption of the 2-step process within the clinical practice study.

Okay. Great. Well, I want to shift gears a pivot. This is your intermediate risk NMIBC Phase III. First randomized Phase III in this setting and enrolled nearly 9 months ahead of schedule with top line expected and reiterated for the first half, so in the coming months. What, I guess, constitutes the clinically meaningful result here? What is sort of the minimum RFS bar versus the results that lets you describe cretos kind of standard of care in this setting.

Sure. So just to paint the picture, there currently is no FDA-approved therapy as an adjuvant for patients with IR and NMIBC really in the U.S. right now. And based on our conversations with physicians, really we've been very consistent that a 30% relative risk reduction is sort of the clinically meaningful minimum bar. We've not said too much about our own kind of internal expectations, but that's what we've been telling investors that, that is a number to minimally that we would have to achieve. And again, once you have an a approved product in this space, it's really our chance to then shape and build that market, right? This is a chance where we're going to be at least 18 to 24 months ahead of the next competitor. So that really unlocks a huge population that's going to be on label.

Okay. And I guess how is the event rate sort of been tracking against your expectations? And -- what does that sort of tell you about the control arm? And is there maybe a good historical comparator, obviously, cross-trial comparison carry their own caveats. But in terms of control arm, is it like the SWOG study or [indiscernible] that you think about?

Yes. When it comes to the control arm, we get that question a lot. I think the hard part is no one has really enrolled the AUA SEO definition of IR and MIBC. I think we're 1 of the few companies who are the first to do this. So we can only find proxies out there. And we've been pointing to the Atlas, which is the UroGen ATLAS trial that had a form with just TRBT. Again, it's not perfect because they didn't allow for a single-dose periodic chemo. So -- and again, they've enrolled primarily ex U.S. So with those caveats, I think we're kind of maintaining our kind of view on is that the control should be in that 50% range around 12 to 15 months would be our expectation. But again, there are a lot of caveats that.

Yes. I think they had some difference in enrollment between like the T1 and this patient...

And they excluded the high-grade patients as well, which we have in our trial.

Maybe a little bit more aggressive patient grew as well.

Just on the surface of it, because they went for a low-grade IR ex U.S., I think in a U.S. population that includes high-grade IR patients that could potentially be different.

Okay. And I guess, have you guys given much thought in terms of how you're going to update the market once the study does read out? Would it be sort of the top line with a medical meeting for the full data?

Yes. So I think, again, because it's event driven, obviously, once we're ready to present that information, we'll probably disclose it. Should it fall around a conference that will be great. If not, there will be a stand-alone release on that. And certainly, investors can expect the primary endpoint be reported beyond that, at least the median length of follow-up on these patients.

Okay. And you said even with the top line in hand, you'll still -- obviously 12-month RFS that you'll be fitting on. So even if you step through the event...

12 months will come later. It might be actually a few months later when we see the true.

Okay. Okay. And then when you think about the sequential BLAs, how are you thinking about pricing framework and intermediate risk versus BCG on responsive. I guess there could be maybe different dosing schedules to grow.

That is true. So in BCG on responsive disease, it's about 30 doses across 3 years. So 18, the first year and obviously, second year and third year. So that's in the BCG unresponsive study. In the intermediate risk setting, it's 14 doses, just 1 year worth therapy. The pricing will be based on a per dose basis. And this is an ASP product. So we really are not looking at it. We're looking at it as a per dose per indication, I would say, but not really as a totality for 1 indication, it's going to be x price and white price on a dose basis itself, it will be inherently lower intermediate dress versus BCG unresponsive, I would say.

Okay. Okay. That's helpful. I want to ask now about your upcoming presentations at AUA. Cohort CX. This is sort of your entry into the larger BCG exposed population. What should we sort of expect at the AUA in terms of patient number follow-up any sort of framing?

Yes. So that study enrolled a little bit north of 50 patients. And Initially, we set out to enroll just the BCG exposed patients, but we ended up with some patients who are also BCG are responsive. We'll probably not be breaking that out, but we will be commenting on the responses in those 2 categories. And really 1 of the objectives of the study is to figure out whether credo plus gen should be given concurrently or sequentially, right? So there will be more color on that beyond what the abstract has shown. I think 1 of the key things, of course, is to look at the CIS data, which looks at complete response rate at early time points. That information will be shared later this week. And once we have that information, I think it's helpful to think about how does that kind of fit into this landscape? Can we put that into the right context? Our argue is that the exposed market is 50,000 patients, which is roughly twice as large as our initial label. And so that is a population that currently has nothing on the label right now, right? So I think following that data as well as long-term durability results, which I mean, call it, 12 months from the initial data, that's going to be available later in the year. But once we have that full picture, I think that's a direction that's very exciting for us to think about.

Okay. And I guess what sort of efficacy signal would sort of give you conviction assuming that you would need to run a larger randomized Phase III in this setting, I think that's what J&J is doing as well, I guess. What would you want to see to make that commitment and I guess, how do you think about gemcitabine as the combination partner versus other agents?

Yes. I think Jim is something that water soluble and urologists are highly familiar with it, giving it as monotherapy, right? I think when we think about the bar for success in this category, first of all, when you think about BCG exposed and BCG unresponsive, it's a very fine line between the 2, right? One of them is recurrence within 12 months of your last BCG dose or after 12 months of your last BCG dose. So you can see that the cut was made somewhat arbitrarily, right? So we do think about kind of on the worst case is, you got to definitely be better than the agent in the BCG unresponsive monotherapy setting, right? That's one way to think about it. But we do think that having 2 agents that could be given intravesically is really the key advantage here. And with J&J's drug, there's only currently a monotherapy potential. So they're really testing a longer-duration [indiscernible], in their trial. I think we have an opportunity to test a combination approach, which hopefully will show a better response.

Yes. And I guess on the topic of combination, we've seen some, I guess, mixed data for the IO combination in terms of not really moving the needle as much as people would have thought in terms of efficacy. How do you think about the credo/pembro potential combo in which setting would that be most apt for.

Sure. So this was a study called CORE 001. We tested this in 35 patients. And what you can see at the time, we didn't know how good creto mono was going to be, right? So the combo showed about a 50% or so 2-year CR rate, which is excellent. So now that we have creto mono data in hand, Credo itself can do 42% at 2 years. So pembro, again, pembro on its own has about a 9% CRE at 2 years. right? So you can see that as roughly additive, but then you carry all the systemic side effects with pembrolizumab. So I think when it comes to an immune checkpoint inhibitor for this patient population, the bar is very high, right? So some other big pharma have tested PD-1 plus BCG. Some have met its endpoints, some haven't. But then, for example, Pfizer has decided not to pursue their filing with that combination, right? So the bar is definitely high when it comes to a checkpoint, which is why we want to stay focused on just assets that could be combined and given intravesically in the [indiscernible] clinic.

Yes. Okay. That makes sense. Maybe in the last minute or so, I want to sort of end on resources at the company's disposal, how you sort of scale manufacturing both in the U.S. and how you're going to approach the European infrastructure as well? Do you want to do that yourself or a partner? What's sort of the calculus around sort of the capital allocation strategy?

Sure. So when it comes to manufacturing, we previously have mentioned that on our current scale and capacity, we can supply up to 50,000 vials of creto a year right now. But we have been making plans and investments in this space really since the time of our IPO. So that progress is ongoing, and it's going really well. And the goal is eventually to scale that up 10x, right? So once we get there, I think building on the fact that creto is a -- we have a process that's highly robust and scalable. So that allows us to move this pretty rapidly around kind of different manufacturing network sites, right, that we're continuing to invest in expanding into. So we continue to think about how we can supply a larger market which we're about to unlock, hopefully, with the intermediate risk trial.

Yes. Perfect. Well, I think with that, we're right at time. So we'll have to end up there. Look forward to impacting this more at our dinner tonight. But Arthur, Ambaw, thank you so much for the great discussion, and Thanks, everyone, for attending.

Thank you.

Thank you for having us. Thank you.