Conference Transcript - CGON 2026-06-09

Operator

All right. Good afternoon, everyone, and thanks for joining us here at the Goldman Sachs Global Healthcare Conference. Thrilled to be joined on stage today with Arthur from CG Oncology, Chief Executive Officer. I'm going to turn it to you first to just kind of introduce the company and talk about what you think about as key value drivers over the next, you know, 12 to 24 months.

Arthur Kuan, CEO

Sure. So we're a company that's laser focused on developing our oncolytic immunotherapy, for patients with both intermediate risk as well as high risk non-muscle invasive bladder And we have a number of catalysts coming up. Most importantly, we have a phase three randomized control trial called PIVOT006. Its results will come in the coming months. Shortly thereafter, we are guiding to complete our BMIBC setting. And really, towards the back of this year, there will be additional data around durability of our product in the BCGR-responsive setting, as well as when we combine it with gemcitabine, additional durability updates will be available as well.

Operator

Great. So maybe let's start kind of at the highest level. As you look at the non-muscle invasive bladder cancer category, could you talk about how you see the unmet need and how patients are kind of stratified within that indication.

Arthur Kuan, CEO

Sure. So in general, bladder cancer is split into both non-muscle invasive bladder cancer, which is about 80% of the opportunity, and 20% are in the muscle invasive category, of which that contains some metastatic patients. The bulk of the opportunity is still in NMIBC. Within NMIBC, we see 70% of that being the target population that we're going after. So that's in the intermediate risk category as well as the high risk category. And the risk categories are just a way to describe the likelihood of progression into a higher grade disease or eventually muscle invasive disease.

Operator

Okay, great. And then as you think about kind of the unmet need and how patients are treated today, what are the goal like what do you think of is the kind of goal for new therapies entering the market and particularly crudus imaging sure so we'll start with high risk within high risk the standard

Arthur Kuan, CEO

of care for frontline patients where bcg naive is bcg and so following bcg therapy uh you fall into this bcg unresponsive category or bcg exposed category right we'll just start with bcg unresponsive. The goal of therapy here is to prevent radical cystectomy. That's the ultimate treatment objective, which is so that patients can keep their bladders as long as possible. And so there are a couple of approved therapies now. I still think our target product profile represents really the strongest profile in that category. And in terms of BCG exposed, this is an emerging category that really based on the FDA definition of unresponsive. We think it's a bit stringent. It does kind of leave and carve out this population that's neither naive nor unresponsive that we're seeing as an emerging kind of category that the agency has also recognized as an important bucket of patients. In terms of intermediate risk, the goal is to prevent multiple recurrent TURBTs, transurethral resection of bladder tumor, and that's a procedure where the urologists have to go in and resect a tumor in the OR. And oftentimes these tumors continue to recur to the point where the bladder has been scraped so many times, sometimes it's also less functional than before.

Operator

Okay, great. So maybe let's drill down into the BCGN responsive category because it's the most advanced of your development programs. Maybe just remind us of the drugs profile you mentioned it being potentially best in category and the clinical data to date that

Arthur Kuan, CEO

you've shared. Sure. So in BCG, I'm responsive, NMIBC, in the CIS cohort or the carcinoma in situ cohort, we have shown a greater than 75% CR rate, closer to 76% complete response rate at any time. And at 12 months, from a landmark analysis standpoint, we've shown a 46% complete response rate. Most notably, if you go from 12 months to 24 months landmark, cretosimogene as a monotherapy still had a 42% complete response rate. But you'll notice that there's a tail from 12 to 24 months, and we continue to highlight that as one of our key differentiations versus others. And that's really driven by the MOA of the oncolytic immunotherapy that's causing that long tail that you typically don't see with chemotherapeutic approaches.

Operator

And you mentioned, obviously, that one of the differentiating features is that duration. Can you contextualize that duration of response versus what we've seen from many of the other programs in development or approved?

Arthur Kuan, CEO

Sure. So when we think about different ways to kind of cut that data, but if you just take sort of this landmark analysis at two years, right? So Keytruda has a 9% complete response rate at two years. You know, natoferigine, another product, is probably in the 20% range. And then Activa is in the kind of 20% range. We don't know yet what HART 200 has shown at two years. We get to see that at some point.

Operator

In addition to the clinical data, one of the things we hear a lot is that patient experience really matters, physician experience really matters in administering these products. How does the delivery of Cretus Imogene compare to some of the other agents in the category? And could you talk about kind of the infrastructure requirements that would be necessary for a physician's practice to administer the product?

Arthur Kuan, CEO

So we've made a lot of improvements over the delivery as well as the storage conditions of Creative Simagine. One of the things that we heard from our customers directly is that, A, not everyone has a ultra-low freezer. These are freezers that are minus 60 to minus 80. So we developed this new storage condition that allows us to take a product out of the freezer and put it into a regular fridge at 2 to 8 Celsius, which is a regular fridge. In that condition, the product can stay stable from 4 to 6 weeks. So that is an amount of time that we believe is necessary for this product to not have that as a barrier. Other than that, this product does not require any change of workflow. If the site can administer BCG, it typically flows right into that workflow. without any retraining that's required.

Operator

One of the things we've heard is kind of the dwell time consideration. So maybe you could talk about the amount of time a patient will be spending in a prescriber's practice versus some of the other workflows that are out there.

Arthur Kuan, CEO

Yeah, so from a, you know, standard of care BCG, for example, is up to, you know, on label requires a two-hour dwell time. In practice, people only dwell for maybe an hour. and really after the first visit, typically in the second visit, they get instilled BCG, which doesn't take long, maybe less than 10 minutes, and then they would just go home and void at home. So we envision that currently in the clinical trial setting, the dwell time is roughly 15 minutes with DDM, a transduction agent that we use before we give credo, and credo is probably up to 45 minutes an hour dwell time. So all in, you know, an hour and 15 minutes. And after that, they could go home or they typically right now they're staying in the waiting room, right, which opens up that space for the second patient to come in. In the future, of course, we could envision a case where the dwell could be done outside of the clinic, right, which is kind of more in line with how BCG is done.

Operator

In terms of the specific subgroups within BCGN responsive, maybe CAS, papillary only, any mixed patients, are there any particular populations where you think the profile of credo is particularly differentiated?

Arthur Kuan, CEO

I think that's a great question. So our BOND-3 pivotal trial, we had the highest and most heavily pretreated population. So unlike other competitors, we have a lot of patients with prior chemo in addition to failing two courses of BCG. And so I'm referring to patients who failed GEM or GEMDOSI. And even in that category of patients, Credo continues to show a very consistent response rate. And so that is a data that we're certainly going to lean into as we think about the launch and profiling different accounts, both academic and log plus sites, large urology group practice sites. That's certainly one aspect that I think is quite unique.

Operator

So then as physicians look at, they now have a couple of therapeutic options that they can pick from. How do you think they're going to pick which products they'll use and are there any, like what portion of patients then do you think will see Credo at some point during their course of treatment?

Arthur Kuan, CEO

Yeah, I think ultimately they care a lot about safety and efficacy, and that's kind of the base case. And then whether it requires a lot of modifications or changes to their work or sort of the bare minimum that they think about therapies. You can look at the one-year landmark, and it's easy to see that greater than 60% of those patients, and perhaps even more, some therapies up to 80% would have recurrence within the first year. So in those instances, you know, it's not going to be a situation where the site just sticks with one therapy and they only use that one therapy. So there certainly will be a sequencing play here. Of course, I think the target product profile, the durability will all play a role here. In terms of there are some sites who just are really accustomed to giving chemotherapy. And, you know, if we have data that shows, even after that, Credo could still work really well. That's also another consideration for us, because certainly you don't want to give more chemo after initial chemo.

Operator

So you're now on track, I think, for filing in the fourth quarter of the year. Could you maybe provide some additional color on your confidence that you've satisfied the regulatory requirements that you need to kind of satisfy for a filing, both with respect to the clinical data, which we've just discussed, but also the manufacturing piece?

Arthur Kuan, CEO

Yeah, so on May 8th, when we put out the press release, this was in the context of having a prior FDA alignment meeting, and in that meeting, it was entirely manufacturing-focused, and we discussed expectations and alignment on what needs to go into the content of our CMC package. So coming out of that meeting, we felt like all the questions we had were clarified, so we know what needs to be in there from a drafting standpoint and content standpoint. So that workflow continues to be ongoing. And of course, we have a separate work stream that we continue to discuss with investors that we care a lot about inspection readiness. So this really goes hand-in-hand with the content that we're putting in. Essentially, after we've completed the filing, we do anticipate the FDA to come in and inspect all of our manufacturing partners. And we're putting a particular emphasis and focus on the site that we acquired last year. This is the fill-and-finish site. And so we're doing a lot of preparation work on that. And so that work is ongoing, and we feel like from now until that's going to be sufficient time for us to get them ready.

Operator

The area that you focus on has been the site that you acquired, which is primarily, I think, focused on fill and finish. But one of the more traditional areas of manufacturing challenges is maybe not the right word, but is manufacturing an oncolytic virus. What's your level of confidence that you've satisfied the requirements on that piece of the manufacturing process?

Arthur Kuan, CEO

Yeah, so we're very confident that there's alignment with the FDA in terms of what tests we need to use for analytical release. Thankfully, we only have one transgene, so it's very easy to develop an assay that looks at that. So that work has already been completed. In terms of the yield and scale that we currently have, it really, from an initial launch standpoint, we believe that covers the early years of launch. So there's no changes that would be necessary there. So in general, I think we're very much aligned on the virus manufacturing component.

Operator

Okay, great. Maybe you think about filing and then preparing for a go-to-market in the next year. How are you thinking about pricing the market with the eye to the broader development strategy that you guys are engaged in?

Arthur Kuan, CEO

Yeah, pricing is an interesting topic. We've not provided formal guidance on this, but when you think about pricing, safety and efficacy plays a huge role, as well as the benchmark of approved therapies. And so I think in terms of kind of the ranges, on the low end, it's about $260,000 for one year. High end, $700,000 for one year. I think directionally, we'd probably be on the right end of that spectrum. But again, a lot of it still depends on how our intermediate risk data would read out because it's all linked. It's one product for two different indications.

Operator

So how, let's say that Pivot 6 does work, what are kind of the important considerations in terms of pricing differential across the two markets?

Arthur Kuan, CEO

Yeah, so first of all, I would say we've already done the dose de-escalation. When you go from a high-risk disease, which is 30 doses over three years, with intermediate-risk disease, we cap it at one year of 14 doses. So we're aligning on total length of therapy being half of what it's used in high-risk. Of course, there's always the first-year kind of treatment, total cost consideration as well, that will be very important to look at as well.

Operator

Are there good kind of pricing analogs for the intermediate-risk setting that we should keep in mind?

Arthur Kuan, CEO

Well, not yet, because no one has done a randomized controlled trial in the adjuvant setting as broad as we are doing, right? Competitors have so far priced in the ablative setting.

Operator

How are you thinking about sizing your commercial infrastructure, and what can you share regarding sort of the physician targeting efforts that you'd need to take on?

Arthur Kuan, CEO

Sure, so when we look at kind of launch analogs in the space, I think everyone sort of comes out to be around the 50 to 75 field force range I would say based on our own internal analysis we're in that range as well and it's really largely due to the concentration of customers right the key accounts roughly 300 network sites they cover about 80% of all the business opportunities so when we think about that you know just in those accounts it's roughly a 50-50 split between academic and community urology, largely private equity-backed, you know, LugPug groups. And a lot of it has to do with the BCG shortage, and that compounds over time. Because if you don't have patients who need BCG, it's hard for you to order BCG. So that issue, you know, has basically led to sites referring patients to sites that have flow and have access to BCG. So it kind of compounds over time. So when we think about that split, we think about what is the current practice pattern that they're already doing. Is it GEM, GEMDOSI? Is it any of the branded products? So we're studying the pre- and post-JCO dynamics there.

Operator

And in terms of other launches in MIBC, there's a couple that have happened recently. What have you watched and observed in terms of how they've done and things that you would then apply to your own commercial strategy?

Arthur Kuan, CEO

Yeah, so I would say obviously the most recent launch is in Lexo, and we're tracking them very closely. I think reimbursement confidence continues to be a key thing that we look for, which are the sites that are the early adopters who are waiting on the sidelines for a J code. That information I think is very helpful for us to study. And now we have not only the Inlexo data, we also have Anctiva and Natofarigene's data. So that's going to help better inform our initial targeting strategies. So a lot of our profiling work of these key accounts have already begun last year, and we're going to continue to do so into the potential launch next year. And really the focus is to really figure out, like, what were the hurdles and what were the experiences that weren't so good or were really good and how can we make sure we apply those learnings to our launch? And really, I think just ensuring our customers that, hey, we're here to partner with them, you know, in terms of reimbursement confidence, having the right field reimbursement support, I think it's going to be a very important thing to do.

Operator

You mentioned earlier that you've done a lot of things to make the product profile more physician and patient friendly, But I think sometimes there had been a gap in what physicians were aware of that you guys had made progress against. As you look at the educational gaps that you still need to overcome, are there specific areas where you think people need to drive a better understanding of that TPP?

Arthur Kuan, CEO

Yeah, I think it's, of course, some of the improvements that we made in the storage condition may have been, not as broadly disseminated. So that's certainly an area of focus. I would say in the coming months, you know, once we have the data for PIVOT-006, I think that's also another area that will be, you know, kind of a new piece of information that, you know, these doctors haven't necessarily been exposed to before, right?

Operator

You mentioned this at the top, but you're developing crudestomagina combinations as well, including in the same setting. Maybe you could talk about the role that those combination programs play within the context of your broader development strategy.

Arthur Kuan, CEO

Sure. So on one hand, in the intermediate risk category, we are already at the most upstream and top of the funnel in terms of patient flow, right? These are BCG-naive, newly diagnosed, or recurrent IR patients, right? So Pivot 6 covers that patient segment. In terms of high risk, you know, BCG-naive patients, they all get BCG. and then they flow into exposed or unresponsive. We have our pivotal program that's the first BLA that covers BCG unresponsive. Now, what about the BCG exposed patient population? In our own clinical trial experience, we had to turn away many patients who don't fit the unresponsive criteria. So we believe this category of patients is emerging, and currently there is no on-label therapies for those patients. So our current strategy is both with mono and combination of CREDO and CREDO gemcitabine to see if there's any added benefit of CREDO gem in the exposed category. The early data that we've shown at AUA, which is in the CIS population, right, these are patients that don't get a TRBT, we saw about a 90 to 92% complete response rate at six So it's early, but definitely encouraging. We're waiting to see what happens in nine months and 12 months. If that continues to be durable, I think it certainly helps us think through a pathway in the exposed category. And in which case, some randomization would be necessary so then we can get the TAT1 patients for BCG exposed on label as well.

Operator

Can you talk about the different segments of this population and where you might be able to pursue a guideline strategy versus a registrational strategy?

Arthur Kuan, CEO

Sure. So in BCG arm-responsive disease, currently you can only get a label with the CIS-containing disease because surgery is not required. And then with TAT1 disease, these are the pure papillary disease, currently there isn't any FDA-approved product on label. So that typically would go through an NCCN guideline compendia listing strategy.

Operator

So maybe pivoting now to Pivot 6 data here in the next couple of months, maybe first we could just talk about, like, cretostimogene as a product and whether there's any key differences between an intermediate risk and a high-risk patient population that would inform the drug's ability to deliver activity.

Arthur Kuan, CEO

That's a great question. So from our vantage point, the core principles and MOA of how cretostimogene works is that it responds to a protein called E2F, and this is a protein that's very important during DNA replication. So fundamentally, as long as there's DNA replication or recurrence of new cancer cells, we believe there should be sufficient E2F that will then activate cretosimia gene. So that's sort of our foundational understanding and our view of that disease space. We certainly don't have data directly in intermediate-risk, low-grade patients. So that is, you know, we're making that assumption that as long as there's recurrence, there's E2F, you know, it could be active. So that's sort of the baseline. Beyond that, I would say, you know, we're treating patients in an adjuvant setting, so the tumor burden is already pretty low, you know. So that's another condition that I think is unique versus a situation where there's a high tumor burden in terms of both tumor masses.

Operator

Maybe you could provide some background then on the clinical study of FIVID-6 and the timelines. You've had this trial of enrolling. The enrollment timelines have changed, et cetera. So maybe just start there in background of the trial.

Arthur Kuan, CEO

Yeah, so we started enrolling in this trial around mid-2024, and then we completed the enrollment of 364 patients in September of 2025. So that is way ahead of schedule. I think, you know, again, this is the first time that anyone has done this in the U.S., so there are more conservative enrollment projections initially at the outset. But yeah, this is a one-to-one randomized controlled trial looking at, you know, TRBT with or without creatosimagine. And we do stratify for two key factors. One is perioperative chemo, which is a single dose of gemcitabine or not. And then whether the patient has high-grade or low-grade disease or not. So those are the two key stratification factors to make sure the two arms are well balanced.

Operator

Obviously, the enrollment came in a lot faster than expected, but I think there was some changes over the course of time in terms of the number of patients you were targeting for enrollment. Can you talk through the decision there and maybe what you were seeing that you felt comfortable moving down?

Arthur Kuan, CEO

Yeah, so before the study started, we initially wanted to see if we can build in an interim efficacy analysis. Upon speaking with the FDA prior to the start of Pivot 6, they suggested that we just remove the interim efficacy analysis. Instead, just keep it for interim and futility safety analysis. So I can share that the interim futility analysis has been met, so the trial obviously continued, but there really wasn't any advantage of having that interim efficacy analysis because the trial would have been almost fully enrolled anyway at that point. So there's that change in sample size based on that.

Operator

Okay. How do you interpret the faster than expected enrollment that you guys saw? Yeah, so we

Arthur Kuan, CEO

internally view it as just this enthusiasm that a lot of physicians have with a novel therapy for intermediate risk disease, right? There were a lot of skepticism initially going into it, but really I think the enrollment rate on some months we saw 30 to 50 patients coming onto the trial. That was certainly surprising to us and we think it certainly speaks to the totality of the evidence of credo in other settings that have sort of led through into this setting where a lot of physicians want to try it out as well. You've kind of mentioned this

Operator

but this is a bit of a novel program. You're the first to run a study like this and this kind of patient population, particularly the breadth of the patient population. With that background, how did you kind of come up with the key assumptions underpinning the trial size, empowering, et cetera?

Arthur Kuan, CEO

Yeah, for sure. I think initially the only evidence out there was this older trial done in the U.S. by SWOG that looked at whether adding a single-dose perioperative chemo or not would benefit patients. So the control arm is basically TRBT plus surveillance control. And in that study, again, it's not the perfect study because they actually had lower-risk patients included. They actually also included higher-risk patients that in the end of the trial, They found out that those patients actually received BCG. So with those caveats, that trial was sort of this more conservative view of the world that led to the initial design, where initially we had thought it was more of a 70% RFS rate. That was kind of the outset. After the study had started, we looked at the URGIN-ATLAS trial data that came after we started the trial. And we continue to rethink, you know, in a more modern trial, what could a control arm do, right? So when we looked at the total events that's been, it really, from our vantage point, really matches more of a 50% RFS control that would sort of, in our minds, make more sense based on, you know, the newer data that's come out. It's not perfect. The atlas controller is not perfect, as in it's not the perfect analog for Pivot 6, but it is much more recent data than the SWOG trial that I cited that was done more than 10 years ago.

Operator

Maybe then as you think about the bar for clinical success and commercial success, how would you define what you need to see with Pivot 6 to be both clinically and then commercially successful here?

Arthur Kuan, CEO

Sure. So from a clinical standpoint, since there is no FDA-approved adjuvant therapy for this very broad patient population that we have enrolled in Pivot 6, we believe a relative reduction of 30% is what is going to be clinically meaningful. And, you know, even before the start of Pivot 6, you know, we gathered that feedback from many KOLs, but from their vantage point, they just want an approved product, right? So that's sort of the starting position. Certainly, we're going to learn a lot more about intermediate risk disease from PIVOT6. A lot of this, you know, kind of baseline characteristics, how to control them. So I believe we're leading the charm and understanding of intermediate risk disease. So being that first mover advantage, you know, it puts us in a position where we get to prime and educate the market about this disease. And once you have an approved product, typically there are other ways where you can further enhance that. And so in another setting such as CX, we've shown that Credo and JEM could, at least in the early time points, add additional efficacy on top. So we think it's just the beginning.

Operator

One of the questions that we sometimes get is the use of surveillance as a control arm and whether then 30% reduction, like how reflective of clinical practices is that. So could you just speak about the use of surveillance versus alternatives in this intermediate patient population?

Arthur Kuan, CEO

Yeah, again, like, you know, that was certainly one of the questions we had as well. But certainly with the enrollment rates of Pivot 6, clearly people were comfortable with putting patients on the surveillance arm. Again, the progression rate for these patients is not as high in general. Certainly certain subgroups could be higher than others. So, you know, we think based on the NCCN guidelines, TRBT alone is still part of standard practice. And that's really the core argument for why this control arm could stand.

Operator

In terms of then your ability to kind of turn around with that data and file it, I guess what should we anticipate in terms of timelines to filing on the back of PIVOT data?

Arthur Kuan, CEO

Yeah, so, you know, we've been guiding that in 2027 is when we could file the BLA. Currently not narrowing that, but you can imagine a lot of it is just the clinical module. So cleaning the data, doing the right interpretation and writing up that clinical module will be the work that is required. And really aligning with the FDA once that data is available, and then we'll formulate that strategy. But in 2027 is the current guidance.

Operator

And how do you think then you've got the potential to then be first to market there? I guess, how do you think first-to-market status will inform your ability to drive uptake in the intermediate risk setting?

Arthur Kuan, CEO

I think if you think about the indication, it's these are all BCG-naive patients, at least the one we've enrolled in Pivot 6, right? And so it's interesting because, of course, the obvious answer is to go after sites with high volume of BCG, because that helps us with the initial unresponsive launch. But then there could also be a lot of sites that don't have access to BCG. So that's another interesting avenue that we can open up as well. So in the end, the good thing is the same physician treats both unresponsive and intermediate risk disease. So I think there's a lot of overlap and synergy where if we can bring to the customer, the HCP, that, hey, we've got two indications now versus just one, I think that really would kind of open up the topics that we get to engage them on.

Operator

Could you speak then to the operating leverage you could get across both launches in terms of whether you would need to invest more into commercial infrastructure?

Arthur Kuan, CEO

Yeah, so based on our current math, it's still probably in that 75 field force range. However, perhaps on additional kind of medical engagement like MSLs, that could be an area where we could continue to double down on.

Operator

Okay, great. Maybe then in terms of this is a good segue to cash position, I guess you could remind us where your current balance sheet stands, and then what activities from the clinical and then commercial perspective are embedded within that runway guidance?

Arthur Kuan, CEO

Sure. So currently, on May 8th, we reported we have about over a billion dollars on the balance sheet with no debt, and that runway gives us a runway of through 2029. So we're currently covered for all those activities that we just...

Operator

And then I guess as you shift to making money, as you think about capital allocation priorities in that context, anything that you would think about from a business development perspective?

Arthur Kuan, CEO

So first and foremost, I think internally we're very focused on life cycle management. We view that Cretosimagine has a very long tail. We think this is a product that's very hard to genericize or have a biosimilar competitor. But certainly we want to continue to lengthen that and make sure that we can protect those long tail that we see in this product. So that's really the core near-term focus for us.

Operator

I think that brings us basically to time. So with that, thank you so much, Arthur, for joining us. Thanks to everyone who joined us here and on the webcast.

Arthur Kuan, CEO

Thank you.