CG Oncology, Inc. (CGON) May 12, 2026 Conference Transcript

Alex Stranahan. 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 B of A Healthcare Conference. I'm pleased to be joined by Arthur Kahn, the Chairman and Chief Executive Officer of CG, and Ambal Balete, President and Chief Operating Officer. Thanks for being here, guys.

Thank you. Thanks for having us.

Yeah, 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.

Many of you know we've initiated our role, and this is in the BCG unresponsive. So that's one of the key highlights of narrowing that guidance. And the second update, you know, the guidance remains the same that the first half of this year are top line data from the PIVOT6 trial. We do continue to emphasize that it is an event-based trial. It's hard to pinpoint exactly when that would occur, but as of now, we continue to maintain that guidance. And just later this week, we're also very pleased to present the CX trial. This is a trial that's studying credo plus gemcitabine in a combination in BCG-exposed unresponsive patients. I have reasons to believe that the combination could potentially be you know additive because of that data is now available on the abstract but at UA we're going to be presenting the full data set so for that you know 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, do you think that could potentially be a benefit to the company?

Obviously a lot going on with the company and a lot of different subtypes within non-muscle invasive bladder cancer. I guess, you know, when you think about the pivot top line, the cohort CX from CORA 008, the rolling BLA on track for completion this year, I guess, how do you sort of manage sequencing, Just thinking, if you've got the intermediate risk data in hand, modules, for example, the manufacturing module will be shared across those two BLAs.

Our current plan is still to complete the first BLA before sequentially filing a second BLA on Pivot 6. So 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 you know 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 maybe we can go one by one just just on the bond 003 BLA this is in the high risk PCG repopulation I guess in terms of what's left on the rolling submission how we pair this with with FDA's new

CMC flexibility guidance. I think you said in the past that this could maybe affect your, where do the remaining gating items sit, facility inspection readiness, the CMC package, or anything about the clinical data?

I think it's important to note that because Credo has breakthrough therapy designation, BTD, it does allow us to have, I think the press release from the FDA in January suggest that there is this willingness and offering requirements for sponsors in the cell and gene therapy category, right? So that's more a broad-based, you know, audience. I think in our recent communications with the FDA, you know, we basically got the alignment and clarity that we were able to narrow down our BLA completion. And you pointed out facility inspection readiness activities. That continues to be a key. In this CGT space, there's been a lot of manufacturing-related issues. We're ultra-focused on that, especially around the facility that we just acquired last year that specializes in 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.

The alignment with the FDA, would you characterize that as kind of in line with your expectations and what you were already kind of working towards or were there additional or less obligations?

I can't go into the play-by-play, but in general, it's an alignment that's provided more clarity for us. Very helpful.

Okay. And maybe when you think about the competitive landscape in the high-risk PCG on responsive, your 24-month landmark CR data and kind of the durability piece is best in class from what we've seen versus NGIN and others. I guess based on the Enlexa label would be the on-label sort of efficacy metrics. I think they had 12 months. Do you think that would make a competitive label for you, and how would you sort of position that vis-a-vis the long-term data?

Last year when that label became available, referring to the Enlexa label, I think at the time of the initiation of our role in BLA submission, And data 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 lead to a longer tail. And we've already shown that. So I think anything beyond that 12-month durability label that, you know, and Lexo 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, you know, something that the physicians and patients have their ability. Beyond that, I think our strength in our AE profile.

Yeah. Yeah, well, maybe we can talk about sort of the commercial build-out. When does this fall into place? I think you've described in the past maybe 75 field reps who could cover, you know, 300 urology network sites, which is the majority of the volumes, potentially. I guess, how does this sort of compare against what J&J, to having them build out the initial market and having you come in?

Yeah, 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 Alexa 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've 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 a launch strategy. Our launch team has been in place, you know, really for a while now. And our team of, you know, 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 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 build 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 you know 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 patients that are being switched from other therapies and so on what are those types of patients because of credosimaging's clinical data and safety profile, we have potential eligible patients. The first right after BCG, the patient that may have failed TAR-200, the patient that may have failed GEM or GEM-DOSI, the patient that may have failed Pembrolizumab. Those are all patients that will be eligible patients for credosimaging.

I guess when you think about the targeted rollout, you obviously, per label, it's expected that you'd have to step through BCG. Does that limit the potential prescriber? And is there any, I guess, logistical considerations, especially when we think about...

I would say the following. I don't think it, you know, whether it's in large academic setting or in the community setting, that that really is a differentiated approach. And we think their eligible patients in the community will 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 that are 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 with creatostimogene, for example, in the intermediate risk trial, in the cohort CX trial, or even in the Bond 3 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 in itself. That by and itself 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 as repeated cytoscope based we hear about you know pressure on the bladder from the pretzel. How does this sort of translate into a real-world competition?

I mean I think in terms of the physician dialogue and discussion is, you know, a TAR-200 procedure is a cystoscopic procedure that actually patients have to undergo every three 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 that practice, versus cretostimogene, which is very similar to the BCG experience they It's intervestically delivered by a nurse or 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, you know, DDM, followed by cretostimogene for about an hour, 45 minutes to an hour. So it's truly a differentiated procedure versus an interventional procedure that may require a physician to actually administer the procedure, which in many cases it does, especially the removal. So there are two aspects of this that you have to consider. So it's not just the placement, but the subsequent removal requires kind of that two-step. 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, so there's two times that you're going in and out of that patient's bladder in itself. So that, you know, and then you need a full kind of setup, camera system setup, and those types 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.

I guess two potential points of pushback that I've heard is that with the pretzel, the physicians get to build one, and then the second is around the logistics, sort of a just-in-time, how do you think about five-step versus two-step on the initial label?

Sure, you know again, good question. So just getting back into the practice economics that you mentioned earlier, you know, most of the economics on this product are on the drug side of the equation. Most of really what a practice earns is really the You know, depending on the setting or 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, 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 $100 differential potentially in many instances. Again, most of the economics is on the drug. you know, TAR 200 is $690,000 per year or $69,000 a dose plus 6%. That's where the economics is. It's not on the $100 or $150. So that's on that aspect of it. In terms of the actual in-practice adoption, so from a process of adoption perspective, you know, we intend to deliver We're 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, you know, four weeks plus, okay, a normal refrigerator. You can leave it in the box until the patient comes for up to five days and then take it out of the box. It takes about 15 to 20 minutes to prep and administer to a patient. It does give you a lot of flexibility. And then the two-step process, which we've shown data on the two-step versus five-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 the majority of patients to date have actually undergone the two-step process versus the five-step process. For example, all of the patients in cohort CX, all of the patients in pivot six, all underwent. There's a tremendous amount of body of clinical experience in the adoption of the two-step process within the clinical practice.

Great. Well, I want to shift gears. I almost said pivot to pivot six. This is your intermediate risk NMIDC phase three. First randomized phase three in this setting, enrolled nearly nine months ahead of schedule, offline expected and reiterated for the first half, so in the coming months. What, I guess, constitutes a clinically meaningful, sort of the minimum RFS bar?

FDA approved. We 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, you know, minimally that we, you know. And again, once you have an A approved product in this space, it's really our chance to then shape and build that market. 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.

And I guess, you know, how has the event rate sort of been tracking against your expectations? And, you know, what does that sort of tell you about the control arm? And is there maybe a good historical comparator? Obviously, cross-trial comparisons carry their own caveats. But in terms of control arm, is it like the SWAT?

When it comes to the control arm, we get that question a lot. I think the hard part is no one has a SEO definition of IR and MIBC. I think we're one of the few. So we can only find into the ATLAS, which is the Urogen ATLAS trial, that had a control arm with just TRBT. Again, it's not perfect because they didn't allow for a single-dose perioperative chemo. So, and again, they've enrolled primarily ex-U.S. So, with those caveats, maintaining our kind of view on this, that the control should be in that 50% range around 12 to 15 months would be our own expectation. But, again, there are a lot of caveats to that. Yeah, I think they had some difference in enrollment between, like, the T. Excluded to high-grade patients as well, which we have in our trial. Yeah, maybe. of the purpose of it because they went for a low-grade IR ex-US, I think, in a U.S. population that includes high-grade IR patients.

Have you guys given much thought in terms of how you're going to update the market once this readout? Would it be sort of the top line with a medical meeting?

I think, again, because it's event, they're ready to present that information. We'll probably disclose it. 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 be on. So even if you step through the event, it might be, actually. And then sequential BLAs, how are you thinking about the pricing framework and intermediate risk?

It's about 30 doses across three years. So 18 the first year, and obviously second year and third year. So that's in the BCG unresponsive setting. In the intermediate risk setting, it's 14 doses, just one year. Pricing will be based on a per-dose basis, and this is an ASP product, so we really are not looking at it, you know, we're looking at it as a per-dose, per-indication, I would say, but not really as a totality for one indication. It's going to be X price and Y price on a dose basis itself. It will be inherently lower, intermediate risk versus BCG unresponsive disease.

Okay, that's helpful. I want to ask now about your upcoming presentation, but a cohort see a larger B2C patient number.

We set out to, but we ended up with some patients. We'll probably not be breaking that out, but we will be commenting on the responses in those two categories. And really, one of the objectives of the study is to figure out, you know, whether Credo plus Gem should be given concurrently or sequentially, right? So there will be more color on that beyond what the abstract has shown. I think one 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, how does that kind of fit into this context? Our view 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 you know following that data as well as long-term durability results 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 you know I guess what sort of efficacy signal would give you conviction assuming that you would need to run a larger randomized stage 3 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, you know, I guess, how do you think about gem site?

Yeah, I think gem is something that, you know, water-soluble and gerologists 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, It's a very fine line between the two, 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, you know, you've got to definitely be, that's one way to think about it. But we do think that having two agents that could, and with J&J's drug, there's only currently a monotherapy potential. So they're really testing, you know, a longer duration gem versus gem, right, in their trial. I think we have an opportunity to test a combination approach.

Yeah, and I guess on the topic of combinations, 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?

Sure, so this was a study called Core001. We tested this in 35 patients. And what you can see, at the time, we didn't know how good Credo-Mono was going to be, right? So the combo showed about a 50%. But now that we have Credo-Mono data in hand, Credo itself can do 42%. So, again, Pembrol on its own has about a 9% CRA at two years, right? So you can see that it's roughly additive, but then you carry all the systemic side. When it comes to an immune checkpoint inhibitor for this patient population, Some other PD ones, some have met its endpoints, some haven't, but then, you know, for example, Pfizer has decided not to pursue that combination, right? So the bar is definitely high when it comes to checkpoint, which is why we want to stay focused on just find and give in intrabesically in the neurology clinic.

Okay. That makes sense. Maybe in the last minute or so, I want to sort of end on, you know, 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? What's sort of the calculus around sort of the capital allocation 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. So once we get there, I think we have a process that's highly robust and scalable. So that allows us to move that we're continuing to invest and how we can supply a larger market, which we're about to unlock, hopefully.

I think with that, we're right at time, so we'll have to end it there. I look forward to unpacking this more at our dinner tonight. But Arthur, Enbaugh, thank you so much for the great discussion. Thank you for having me. Thanks, everyone, for attending. Thank you for having us.