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

Sure, makes a ton of sense. I guess on the BCG supply side, that's about to change, I believe, with Merck opening a facility that triples capacity of BCG by the end of this year. So how do you think that might change the way that BCG-naive patients are treated? And do you see any read-through for the BCG-unresponsive therapies that we discussed? And does more available BCG expand the funnel of patients who eventually become unresponsive and reach you, or does it strengthen BCG's hold on the front line and raise the bar for displacing it?

That's a great question. Yes, so BCG again, works reasonably well in the frontline BCG-naive setting. So the bar has always been very high to tap into that space. Should there be a tripling of BCG supply, then what could happen is more patients who are currently not receiving the full course of BCG could then receive that. You're right, I think the dynamics and split between exposed and unresponsive could potentially shift. Because our current view is that the unresponsive market is 25,000 patients and in an exposed population it's about 50,000 patients. So there could be potentially a shift there should there be a tripling of supply. I think when it comes to the intermediate risk opportunity, it's still pretty wide open. 10 years ago, those patients would have received BCG. However, practice patterns have changed, guidelines have changed. So being potentially first in that adjuvant setting there, I think, you know, really, even if BCG were to come back, having an improved product in that setting, I think we'll also be in a very good position.

Fantastic. Thank you, Arthur. Moving on to BOND-003 and the high-risk data package, so the BOND-003 cohort data showed 75.5% complete response at any time and median duration of response are around 28 months, and you've highlighted that 90% of 12-month responders remain in response at 24 months. Mouthful. As you talk to investors and physicians, which of those numbers do you think best capture the differentiation, and how do you frame durability against the competing profiles?

Yes, so if you just look at what's, I think the 12-month CR rate is usually something that people care about because it's something very intuitive that, hey, I start treatment today. Am I going to have my bladder in 12 months? So there's that number. And I think what's often surprising is that durable tail that I talked about from 12 to 24 months. That 90% durable response during that period, I think it's quite surprising.

And I think it's also differentiating. Sure, thank you. And on the label you're filing for, the CIS population with or without papillary disease, you know, help us bridge to the papillary only and the BCG-naive data sets. With Cohort P showing high grade event-free survival 80s at 9 months and CORE-008, 88% complete response in BCG-naive. How do those cohorts factor into your life cycle and label expansion strategy? What's the timing and how does the BCG supply outlook shape how you'd position creto in the naive setting as a BCG alternative, a combination or a therapy for patients who can still access BCG?

Great, so I'll start with the BCG-unresponsive papillary patients. This has been a population that typically would not be for BLA approval. Most competitors have gone on to the NCCN Compendium listing and they are being reimbursed based on that. Obviously, there is a competitor who has a PDUFA date for that population in January. So we'll be watching that pretty closely. But we'll have the 12-month results end of the year for that cohort and we intend to publish it at a peer-reviewed journal to just get the necessary steps ready. And you talked about the BCG-naive data set, the 88% complete response. I will perhaps, you know, remind you and the audience here that we actually have a very exciting creto plus gemcitabine combination data shared earlier this year and that was done in a setting of BCG-exposed and BCG-unresponsive patients. So of 50 patients we had about 50-50 each in unresponsive and exposed. The data was very similar but we had achieved about a 90% event-free survival at 6 months. So very promising. With that data set, we had an alignment meeting with the FDA around a Phase 3 concept, which is we want to enable a Phase 3 trial in the BCG-exposed setting. Using creto plus GEM versus GEM. So we got the confirmation and so pending the 12-month results that we're going to have later this year, we're going to figure out the proper sizing for that study and pursue that potentially early next year. So that would then help us unlock that additional 50,000 patients I spoke about earlier, right. So I think that's a space that is a very low-hanging fruit that may not have received as much attention recently.

Sure. That's awesome. Moving on to PIVOT-006 in intermediate risk, which is the big near-term catalyst to us. You know, the first randomized registrational trial in intermediate risk NMIBC has pulled forward roughly 1 year, top line expected imminently against a surveillance control. How do you define a clinically meaningful result? And how much do you want the market focused on the hazard ratio versus the absolute recurrence-free survival split?

Great question. So, given the randomized nature of the study, the primary endpoint is recurrence-free survival, and that's going to be expressed in a, you know, hazard ratio format, which again, it really means, you know, are you reducing the rate of recurrence, right? So we've been saying, and this is based on our feedback, talking with KOLs and physicians, a 30% relative risk reduction would be clinically meaningful. So we think that's, you know, given that there is no approved product in that category right now. There's a competitor product in the ablative setting. Our position and based on our trial design, we're going after patients who have completed a full TURBT. So I think this is an area where you can you asked about the hazard ratio versus the 12-month, it's, you know, from a urologist's perspective, they potentially will not compute the hazard ratio the same way a regulator would look at it. So they may also want to look at the 12-month landmark numbers.

Sure, sure. And how do you think about the control arm performance? And does a stronger than expected control arm worry you if it compresses the absolute benefit, you know, even with a good HR?

That's a great question. You know, I think the control arm here, the truth is, I think PIVOT-006 will be the answer to how does the control arm perform. Obviously, ahead of that, we think the best, closest proxy would be the ATLAS trial, of which, you know, the control arm had a TURBT treatment option. And so that you know, kind of trends in that 50%, 12 to 15-month RFS range in that specific setting. Right? So, I think, when we talk about hazard ratio, it's always done in a relative risk reduction concept. So as long as we can continue to achieve that, we still think we'll be in a very good shape to demonstrate that we can reduce the number of TURBTs for these patients.

Sure, sure. And the study's enrolled a broad range of intermediate risk patients. So how should we think about a pooled RFS number across that heterogeneous population? And could subgroup performance end up mattering as much as the headline?

Yes, so the study is not powered by each subgroup. So we definitely have a lot of capped certain subgroups, for example, like the high-grade Ta to a certain amount to make sure it's well-balanced, right? But across the board, I mean, these are all defined as intermediate risk patients. You know, we think ideally both the newly diagnosed recurrent low-grade high-grade could all be part of it. And that would give us the broadest label versus the competition.

Sure, thank you. And how are you thinking about the intermediate risk opportunity versus BCG-unresponsive in terms of both addressable patients and market size?

Sure. So this one, intermediate risk is one where you have to go and create the market. I think BCG-unresponsive has a very well-defined market at this point. It's still growing. I think with when it comes to intermediate risk, creto could potentially be the first market, especially in the adjuvant setting. So it's one where we have the responsibility to go and shape that market. In absolute number of patients, it is twice the size of the unresponsive patients. So just in terms of sheer number of patients that are addressable, it is a much larger opportunity.

Sure. And assuming that you do have a positive readout, what's the path and timing to a second filing? And could it quickly become a commercial contributor along with the high-risk?

Yes. Yes, so that's one where what we've been saying is, you know, once we have the data, we're going to have to engage the FDA. Mm-hmm. Certainly, there are different filing considerations here. But I think we'll have a very open dialogue with the FDA because they share a lot of the same parts, right? They share the same non-clinical and CMC modules. The only part that's different is the clinical module.

Right, thank you. Moving on to some questions around combination and earlier lines and CORE-008 and CORE-001. What did the combination teach you and how does it change how you think about positioning monotherapy you know versus combo as you move into earlier lines?

Yeah, so this is a great example where early on in our development plans, we had tested creto plus, a systemic checkpoint agent, for example. And the results were additive. But we learned quickly that the urologist would really prefer to keep the patient in their practice, that a pure intravesical combination versus 1 intravesical, 1 systemic might be preferable. So here's a case where, you know, creto plus gemcitabine, these are 2 orthogonal MOAs coming together. And based on the sequential treatment regimen, which is creto, creto, GEM, you know, it seemed to generate really good results versus the concurrent creto GEM. So we're more likely going to take forward the creto, creto, GEM sequential therapy. It's going to be less burdensome for the patient because each visit there's only 1 agent that's being administered. And, you know, GEM when it's given on its own, it doesn't have a lot of, you know, long-term side effects either. And so, you know, given the early data, it seems to be additive. And so we await to see the 12-month results. And if it holds up, it's definitely very promising.

Sure, sure. Thank you, and on the BCG-exposed population, you know, that in-between group that's neither naive nor unresponsive. Why do you believe in that market? How large is it? How do you think about the path to addressing it?

Yes, so conceptually, every year in the U.S., 25,000 new high-risk BCG-naive patients come to the market. They all get some form of BCG, even during the shortage, right? Because in fact, BCG should be preserved for these patients. So from there, you then have 2 pools of patients, 1 who are BCG-exposed, 1 who are, you know, BCG-unresponsive. So in our own experience, we had to turn away a lot of patients who don't fit the FDA definition of BCG-unresponsive, which is 5 plus 2 doses of BCG recurrence within 12 months. So anything outside of that, this is a really wide net that currently is all off-label. So, you know, based on the BCG claims data, we know there are a large number of patients actively on BCG, and we understand that the narrow FDA definition was really meant for a regulatory purpose. So really having this potential label recognized really helps us capture everyone downstream of receptive BCG.

Sure, thank you. Moving on to financials and strategy, so you have roughly $1 billion in cash runway into the second half of 2027 and you've recently added $500 million through the ATM. With quarterly burn around $80 million and launch spend ramping, how are you thinking about whether the current position fully funds you to and through launch, and what would prompt you to tap the ATM further?

So currently, all the programs that I just described, including the BCG-exposed Phase 3, they're all covered part of our current cash runway guidance. I think in general our view on this is, you know, any kind of SG&A spend would have to be fit for purpose on where the needs are with respect to commercial as well as R&D. I think you kind of titrate up and down depending on where you are with those activities. When it comes to R&D, I think we still think there is a number of opportunities that we can potentially tap just with creto and just within bladder cancer. All right. So, you know, we've already kind of done some of the building blocks with, for example, muscle-invasive bladder cancer, but more work will be done on that. So, we remain pretty disciplined with how we're spending capital.

Yes, so as recent as August, and even at this conference, we're saying that it's in the... I guess the #1 inbound I get is when are we getting the PIVOT-006 data? So what's your latest answer to that, Arthur?

Near term. No, we just appreciate everyone's support. We have a lot of exciting catalysts coming up, and so I think you've covered all of them.

Fair enough. Now, I've run out of my questions. Apart from this final one, is there anything that I didn't ask that I should have or a message you'd like to leave investors with? Appreciate your time, Arthur, and thanks, everyone.