CG Oncology, Inc. ($CGON)

Good afternoon, everyone, and thanks for joining us here. I'm 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 you first to just kind of introduce the company and talk about what you think about as key value drivers over the next 12 to 24 months?

Sure. So we're a company that's laser-focused on developing our oncolytic immunotherapy, creative imagine for patients with both intermediate risk as well as high-risk non-muscle invasive bladder cancer. And we have a number of catalysts coming up. Most importantly, we have a Phase III randomized controlled trial called PIVOT 006. Its results will come in the coming months. shortly thereafter, we are guiding to complete our NMIBC setting. And really towards the back half of this year, there will be additional data around durability of our product in the BCG responsive setting as well as when we combine it with gemcitabine, additional durability updates will be available as well.

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

Sure. So in general, bladder cancer is split into both non-mass 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. So the bulk of the opportunity is fill 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.

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 is the goal for new therapies entering the market, and particularly, credosimaging?

Sure. So we'll start with high risk. Within high risk, the standard of care for frontline patients for BCG naive is BCG. And so following BCG therapy, you fall into this BCG responsive category or BCG exposed category, right? We'll just start with BCG responsive. 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 proof 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 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, transient retro resection of bladder tumor. And that's a procedure where the urologists have to go in and resect the tumor in the OR. And oftentimes, these tumors continue to recur to the point where the bladder has been scraped so many times, sometimes also less functional than before.

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

Sure. So in BCG a responsive NMIBC, in the CIS cohort or the Carsten 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-month landmark, cretosimogine as a monotherapy still had a 42% complete response rate. But you'll notice that there is a tail from 12 to 24 months and -- we continue to highlight that as 1 of our key differentiations versus others. And that's really driven by the MOA and of the oncolytic immunotherapy. That's -- we think is causing that long tail that you typically don't see with chemotherapeutic approaches.

Okay. Great. And you mentioned obviously that 1 of the differentiating features of that duration. Can you contextualize that duration of response versus what we've seen from any of the other programs in development are approved?

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 2 years, right? So KEYTRUDA has a 9% complete response rate at 2 years. Nanoferogene and other product is probably in the 20% range. And then Activo is in the kind of 20% range. We don't know yet what Par 200 has shown at 2 years, but hopefully, we get to see that at some point.

In addition to the clinical data, 1 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 criticimaging compared to some of the other agents in the category? And -- and could you talk about kind of the infrastructure requirements that would be necessary for a physician's practice to administer the product?

Sure. So we've made a lot of improvements over the delivery as well as the storage conditions of creative imaging, One of the things that we heard from our customers directly is that, hey, not everyone has an ultra-low freezer. -- that 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 free forage. And in that condition, the product can stay stable from 4 to 6 weeks, right? 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.

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 prescribers practice versus some of the other workflows that are out there.

Yes. So from a standard of care of BCG, for example, is up to -- on label requires a 2-hour dwell time in practice, people need to offer maybe in power. 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, transduction agent that we use before we give Credo. And credo is probably up to 45 minutes an hour to all time. So all in 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 has done.

Right. In terms of like the specific subgroups within DCG N responsive, maybe CAS, papular only mixed patients? I guess, are there any particular populations where you think the profile of credo is particularly differentiated?

I think that's a great question. So our BOND 3 pivotal trial we had the highest kind of most heavily pretreated population. So unlike other competitors, we have a lot of patients with prior chemo in addition to failing 2 courses of -- 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 logos, large enology group practice sites. That's certainly 1 aspect that I think is quite unique.

Okay. So then as physicians look at -- they now have a couple of therapeutic options that they could 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 we'll see Credo at some point during their course of treatment?

Yes. 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 considerations are sort of the bare minimum that they think about therapies. You can look at the 1-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 a recurrence within the first year. So in those instances, it's not going to be a situation where the site just sticks with 1 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 and the durability will all play in a role here. In terms of -- there are some sites who just are really accustomed to giving chemotherapy. And 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.

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 our filing, both with respect to the clinical data, which we've just discussed, but also the manufacturing piece.

Yes. So on May 8, 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 in sufficient time for us to get them ready.

The area that you focus on has been the site that you acquired, which is primarily, I think, focused on fill and finish. But 1 of the more traditional areas of manufacturing challenges is maybe not the right word, but it is on manufacturing and oncolytic virus. What's your level of confidence that you've satisfied the requirements on that piece of the manufacturing process.

Yes. So we're very confident that there's alignment with the FDA terms of what the tests we need to use for analytical release. Thankfully, we only have 1 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.

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

Yes. 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, right? And so in general, I think in terms of kind of the ranges on the low end, it's about $260,000 for 1 year and $700,000 for 1 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 will read out because it's all linked. It's 1 product for 2 different indications.

So how -- let's say that Pivot 6 does work? What are kind of the important considerations in terms of pricing differential across the 2 markets.

Yes. So first of all, I would say we've already done the dose the escalation when you go from a high-risk disease, which is 30 doses over 3 years with intermediate-risk disease, we cap it at 1 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.

Okay. Great. And are there good kind of pricing analogs for the intermediate risk setting that we should keep in mind?

Well, not yet because no 1 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.

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

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 yield 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, just in those accounts, it's roughly a 50-50 split between academic and community urology, largely private equity-backed Lugugroups. 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 have basically led to sites referring patients at sites that have flow and have access to PCG. So it kind of compounds over time. So when you think about that split, we think about -- what is the current practice pattern that they're already doing? Is it gem? Is it any of the branded products? So we're setting the post -- pre and post J-code dynamics there as well.

Okay, great. And in terms of like 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?

Yes. 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, right? That information, I think, is very helpful for us to study. And now we have not only the lexo data, we also have ANTA nanoperogenes data. So that's going to help better inform our kind of 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 figuring out like what were the hurdles and what were the experiences that weren't so good 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. In terms of reimbursement confidence, having the right field reimbursement support, I think it's going to be a very important thing to do.

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 like a gap in what physicians were aware of that you guys had made progress against. As you look at the educational gap that you still need to overcome? Are there specific areas where you think people we need to drive a better understanding of that.

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

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

Sure. So on 1 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, BCG naive patients, they all get and then they flow into exposed or are responsive. We have our pivotal program. That's the first BLA that covers BCG responsive. 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 cretogemsanabine to see if there is any added benefit of accretive 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 6 months. So it's early, but definitely encouraging. We're waiting to see what happens in 9 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 TAT-1 patients or BCG exposed on label as well.

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?

Sure. So in BCG unresponsive disease, currently, you can only get a label with the CIS containing disease because surgery is not required. And then with TAT-1 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.

So maybe pivoting now to Pivot 6 data here in the next couple of months. Maybe first, we could just talk about like Kratos imaging 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.

No, that's a great question. So from our vantage point, the core principles and MOA of how accretive imaging 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 all then activate cretoymagyn, right? So that's -- 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 -- we're making that assumption that as long as there's recurrence, there's E2F, redo could be active. So that's sort of the baseline. And beyond that, I would say we're treating patients in an adjuvant setting. So the tumor burden is already pretty low. So that's another condition that I think is unique versus a situation where there's a high tumor burden in terms of bulk tumor masses.

Great. Maybe you could provide some background on the clinical study of PIVOT 6 and the time lines you've had this trial, you've enrolling the enrollment time lines have changed, et cetera. So maybe just start there on background of the trial.

Yes. 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 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 yes, this is a 1-to-1 randomized controlled trial looking at TRBT with or without credosemogine. And we do stratify for 2 key factors. One is perioptive chemo, which is a single dose of gemcitabine or not and then whether the patient have high-grade or low-grade disease or not. So those are the 2 key stratification factors to make sure the 2 arms are well balanced.

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?

Yes. 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 futility safety analysis. So I can share that the interim futility analysis has been met. So there's -- 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.

Okay. How do you interpret the faster-than-expected enrollment that you guys saw?

Yes. So we 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 as well.

You've kind of mentioned this, but this is a bit of a novel program. You're the first to run a study like this in 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 and powering, et cetera?

Yes, for sure. I think initially, the only evidence out there was this older trial than in the U.S. by SWOG that looked at whether adding a single dose perioperative chemo or not would benefit patients. So this wasn't -- the control 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, right, where initially, we had thought it was more of a 70% RFS rate. That was the kind of the outset. After the study has started, we looked at the EUROGIN ATLAS trial data that came after we've started the trial, and we continue to rethink in a more modern trial what could a control arm do, right? So when we looked at the total events that's been crewing, it really, from our vantage point, it really matches more RF control that would sort of, in our minds, make more sense based on 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.

Okay. Great. maybe then as you think about the bar for clinical success and commercial success, how would you define what you need to see with V6 to be kind of both clinically and then commercially.

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 even before the start of Pivot 6, we gather that feedback from many KOLs 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 PIVOT 6. A lot of this kind of baseline characteristics, how the control is going to do. And so I believe we're leading the patient and understanding of intermediate risk disease. So being that first mover advantage, 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. right? And so in another setting such as CX, we've shown that credo and Jim could at least in the early time points at additional efficacy on top. So we think it's just the beginning.

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

Yes. Again, like that was certainly one of the questions we had as well. But certainly, with the enrollment rate 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 -- we think based on the NCCN guidelines, TURBT alone is still a part of senior practice. And that's really the core argument for why this control arm could stand.

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 time lines to filing on the back of pivot data?

Yes. So 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's 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.

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?

I think if you think about the indication, it's -- these are all BCG naive patients, at least the 1 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 at BCG because that helps us with the initial unresponsive launch. But then there can also be a lot of sites that don't have access to BCG, all right? 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 on responsive and intermediate risk disease. So I think there's a lot of overlap in synergy where if we can bring to the customer, the HCP say, hey, we've got 2 indications now versus just one. I think that really would kind of open up the topics that we get to engage in on.

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?

Yes. 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 that could be an area where we can continue to double down on.

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

Sure. So currently, we -- on May 8 we reported, we have about over $1 billion 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 described.

Okay. 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?

So first and foremost, I think internally, we're very focused on life cycle management. we view that creative imaging has a very long tail. We think this is a product that's very hard to generisize 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 right? So that's really the core near-term focus for us.

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

Thank you.