Conference Transcript - CGON 2026-06-03

Faisal Krashid, Analyst — Jefferies

Good morning, everyone. Thank you to those in the room and to those dialed in on the webcast as well. My name is Faisal Krashid. I'm one of the senior biotech analysts here at Jefferies, and we are here live at the Jefferies Global Healthcare Conference in New York. Really pleased to have with us today the management team of CG Oncology. Arthur Kwan, the CEO, is here with us today. We're going to have a super interesting discussion on anything and everything cretosimogene related very pivotal time for the company progressing towards a BLA as well as several important data reouts over the course of the year so with that Arthur could you just start by introducing the company for us sure thanks for having us so CG oncology is a company that's laser focused on developing cretosimogene which is an oncolytic immunotherapy in the setting of non-muscle invasive bladder cancer.

Arthur Kuan, CEO

This is a setting in the U.S. that we believe could address up to 150,000 patients. And so we've been solely focused on this, and we believe cretosimaging can really make a huge impact in this specific segment.

Faisal Krashid, Analyst — Jefferies

Got it. So let's jump right into that. I just want to understand within the high-risk NMI-BC, BCG unresponsive setting, starting high level, how do you see crutostomagene fitting in amongst the various options that are available?

Arthur Kuan, CEO

Sure. So in the high-risk BCG-naive setting, these patients first get diagnosed, and then they usually receive BCG. After adequate BCG, which is defined as five plus two doses of BCG, and recurrence within one year, you then fall into this category of BCG-unresponsive disease. this is a disease that is roughly about 25,000 patients a year currently there are a couple FDA approved products the first one was Keytruda and then there was you know a few other competitors J&G's pretzel was also approved recently so in that landscape I think it's still you know in the early innings this is a prescriber base that are still gaining confidence with buy and build products you know but having you know a few competitors ahead of us it's really been educating these physicians and the accounts about buying bill and building reimbursement confidence criticism gene is positioned a very unique way in that none of the approved therapies are on clinic immunotherapies some are pure immunotherapies are non-specific some are chemo based approaches or prolonged chemo you know you know prolonged PK of chemo our MOA is the most uniquely differentiated one in that group all right so briefly our MOA comprises both a oncolytic direct oncolysis of the tumor as well as an anti-tumor immune response that gets activated after tumor cell kill so it's sort of this one-two punch that you can deliver in the bladder and because our therapy does not harm normal cells our AE profile is one of the best you know from a landscape standpoint right now with currently zero grade three adverse events because ultimately what patients care about is preventing radical cystectomy so patients don't want to know well what is my CRA at three months what they want to know is can I keep my bladders at two years three years and five years and can I prevent that from progressing into muscle invasive bladder cancer which then ultimately could turn into metastatic disease, right? So we're trying to intervene right before that.

Faisal Krashid, Analyst — Jefferies

Yeah, and that is a good point that you raise on durability of benefits. I think that is one of the key differentiators that you have for the product. So could you talk to us about what durability have you shown so far? I think you've guided to giving updated durability data this year as well. Can you set expectations on that? And how does that position you relative to the competition here?

Arthur Kuan, CEO

Yeah, so in terms of durability, So, first of all, the CR rate at any time is about 76 percent in our BCG-earned-sponsive CIS cohort, and, you know, the median DRR has not been met, but it's at least over 25 months. And when you look at just landmark at both 12 months and 24 months, so our 12-month landmark is about 46 percent CR. Our 24-month landmark CR rate is 42 percent. So just between 12 and 24 months, 90% of patients who have a CR at 12 months remain in a CR at 24 months. So that's a very interesting tale that really we believe only immunotherapies can achieve. So what could come after that? The study continues out to three years, so we hope to report data out beyond 24 months very shortly, later in the year.

Faisal Krashid, Analyst — Jefferies

Got it. And then can you talk about how that differentiates from J&J's and Lexo? We did a bladder cancer K-Well dinner just the other day at ASCO, and this was brought up as a very important point in differentiation for your drug.

Arthur Kuan, CEO

Yeah, so with J&J's product, TAR200, we've not seen any data beyond 12 months at this moment. So we only know their 12-month landmark, which is about, you know, 45% or so. But given their MOA being a single-agent chemotherapy, certainly, as we know, chemo resistance do develop across different tumor types. So we certainly are lacking that 24-month results or even 30-month results at this point. Obviously, another key differentiation is the tolerability profile. You know, with their approach, you know, there certainly is a lot more toxicity, perhaps related to the device or chemo. but we're not seeing that with our credosimaging approach got it and then you mentioned the the 25,000 patients that are BCG unresponsive high-risk NMIBC can you clarify that's an incident figure and then based on your guys understanding what proportion of that population is treated today with the available options of anlexo and Keytruda yeah so we think of this population as a blend of incidence and prevalence because if you think about it a patient needs to have received five plus two doses of BCG and recurred within 12 months right so it's hard for someone you know to get that exact sequence all within a year so you're definitely going to have patients from prior years coming over and so we know this assumption of 25,000 is just based on a reasonable kind of blend of prevalence of what we think you know through that funnel of post bcg what would then end up in that bcg unresponsive category fitting the fd definition got it so what do you recommend that the street and investors actually model this as a prevalent pool of patients we believe that's the right approach these patients have a pretty decent overall survival rate but then the progression rate as well as the recurrence rate is very high

Faisal Krashid, Analyst — Jefferies

got it do you feel like investors misunderstand that because i feel like one One, you know, pushback that I hear from folks is, well, the incidence is only a few thousand. Like, how big can this market really be? So do you think, do you feel like this is a point that is misunderstood?

Arthur Kuan, CEO

Yeah, I think this is an interesting case where the prevalence pool of, you know, those living in the U.S. with bladder cancer is about 700,000 patients a year. Certainly, we're not suggesting you look at that. But from that pool of 700,000 patients, it's important to think about who have active disease. And we think about the recurrence rate. And you can look at recurrence rates over a 10-year period, over a 5-year period, or in the case of high-risk disease, even in a 3-year period, you can get a high number of recurrence rates. For example, most therapies that are FDA-approved, take adcylidrine, for example. More than 80% of patients on adcylidrine would recur by year 1.

Faisal Krashid, Analyst — Jefferies

So then can you talk to us about where you are on the BLA progress?

Arthur Kuan, CEO

Absolutely. So we started the rolling BLA submission last year in Q4, and we've already guided as of May 8th that we've completed the clinical as well as non-clinical BLA module submissions. So what remains is the manufacturing module that we're guiding to completion by the end of this year.

Faisal Krashid, Analyst — Jefferies

Got it. So can you talk to us a little bit more about that? I mean, this has been kind of a hot topic for investors, given some of the precedent in this space. So can you talk to us about what goes into that? And then, frankly, among investors as well, I think there's a little bit of an educational gap on the time needed and why this is something that you guys are kind of guiding to broadly as within the year.

Arthur Kuan, CEO

Yeah, so when it comes to when we think about manufacturing and de-risking manufacturing, right, there's always a question on supply. Do you have enough supply that you can supply the market, which touches on skill? And so what we've been telling people is the current GMP scale that we have used in our clinical trials as well as the pivotal trials, that process is not changing. That process is sufficient for commercial launch, and that process on an annualized basis can currently yield up to 50,000 vials of creatosimagine. So we're not changing the process. It's locked. All of our analytics and testing methods have also been locked and has been agreed with the FDA. on what those are right it's all the assays now what we focus a lot on is around inspection readiness right this has been a hot topic uh with different companies uh you know catalan for example uh and it usually is in the last step of the manufacturing process which is what we call fill and finish and that step is simply filling you know the product into a file it sounds simple but that is the last step before the product gets shipped to the site and delivered to patients. So we're spending a lot of time on this site that we acquired last year in July, and our goal is to upgrade them so that they're CBER inspection ready. The site has previously been inspected by CDRH, a medical device division, FDA, with no 483 sited. The standards, however, for CBER inspection is a bit different. Certainly, it's kind of higher standards. The good news is we do have full visibility and line of sight into that, right, given our investment.

Faisal Krashid, Analyst — Jefferies

Got it. And is this unique amongst companies in the field to be acquiring and building your own fill-finish capabilities?

Arthur Kuan, CEO

Yeah, I think different companies take a different approach. Some would just build manufacturing capabilities early on. Some gene therapies certainly do that. Cell therapy companies do that. some which is entirely outsourced we're sort of taking more of an opportunistic blended you know option or a hybrid option where our you know production of credo is still outsourced and then we have an in-house fill and finish set up right now got it and then in terms of the outsource manufacturing of drug product can you describe what process goes into that just given the MOA of the drug yeah so you know in general this product is made in a bowel reactor it's off the shelf so it's not patient by patient or batch by batch it's you know a very scalable process because just by describing that the MOA this is a replication competent vector so the yield is actually really good because every cell that it infects it's making a lot more copies of itself right so just from the MOA itself, you can already derive that the yield is going to be pretty good. So this is one where we believe the cost of goods is going to be very competitive, similar to a typical biological product.

Faisal Krashid, Analyst — Jefferies

Got it. And I know more investors are familiar with, like when it comes to viral vectors, AAV, for example. How would you compare this to AAV? Is that even like a valid thought to have?

Arthur Kuan, CEO

Yeah, I think in terms of AAV, the main differences are typically the AAVs are not replication competent they do not like the host cell right I would say the yield for us is even higher than AV approaches and then with regards to the CMC challenges that the field has had can you refresh us on what those challenges have been and what risk you feel do apply to you and what risk you feel do not apply to you yeah so if you think about just within the bladder cancer landscape um there you know there was a crl applied to a company called cess and bio that currently is not here anymore but they had a you know i believe a process change uh that you know also some clinical related um you know uh crl topics as well uh faring for example you know i can't talk too much about kind of the details but based on public information it seems to be also related to a process change. They had scale-up issues related to cost of goods. And again, adcylidrine is a product that, even though it's an adenovirus, it actually does not replicate. And it creates a payload called interferon alpha that also technically is pretty toxic that could kill the whole cell, right? So that manufacturing approach, given its MOA, is very different from ours, and I'm saying that are the risk category is a bit different because we're not needing to change our process right for commercialization you know another company immunity bile they had a pre-approval inspection failure that led to a CRL and that's the category of risks that we believe could be preventable if you focus on what is important right around quality systems And these are things that we are laser focused on by getting the ex-FDA inspectors into our facilities to really make sure we can prep them well for an actual inspection.

Faisal Krashid, Analyst — Jefferies

Got it. So you've had ex-FDA inspectors kind of contract basis like come over and like take a look at everything going on? Okay, cool. So shifting over to commercial readiness, you know, this is a field where, you know, it's dominated by these large community practices. Can you talk to us a bit about the commercial dynamics and your commercial preparations?

Arthur Kuan, CEO

Yeah, so it really starts with our relationships, and we've been doing clinical research and clinical trials with a lot of these sites, starting with our Bond III trial with different cohorts, Core 8, different cohorts, Pivot 6, right? We had up to 90 sites in the U.S., and a huge proportion of them were community sites. So the market, we tend to look at who are the highest kind of users of BCG, who perform the most number of TRBTs, et cetera. There are a few metrics that we look at. Who are the ones that are using branded products? So we take all that information and we think about, you know, how we start to profile these accounts, how we segment the market, And how do we position Credo based on their site's specific practice patterns? So we have all that information, and we're already building out our commercial infrastructure. We'll talk about that more later. But we have a team of MSLs already in the field engaging with customers, you know, who are very interested and curious about our data as well as publications. So all that is really ongoing, and it's been ongoing since last year.

Faisal Krashid, Analyst — Jefferies

Got it. Talk to us about the product handling and administration side of it. So for these large urology group practices, how does that look like? Is that different from other drugs that they use? Like I remember when Keytruda launched, they had the challenge of these lugplugs didn't have like infusion chair capabilities. So that was a little bit of a point of friction. How does your administration handling differ to what these sites are currently capable of?

Arthur Kuan, CEO

So we typically tell the site that if you can give BCG, you can give Credo. And that's really resonated really well. Because most of these LOCPA accounts that see high volume of patients, they understand the BCG workflow. And they understand how Credo can seamlessly fit into that workflow without changing any existing practices. And so, you know, from a shipment standpoint, the product is shipped frozen. it's actually an advantage of ours because we get to build inventory and so it's very stable when it's frozen and at the site once it arrives they just take it out of the box and put it into a fridge at two to eight Celsius so every single site would have a fridge and it's stable that we previously said between four to six weeks or potentially even more and so that resolves a lot of logistics kind of concerns that were previously circulating we also have an adapter called the closed system transfer device all right we didn't invent this but it's off the shelf and it simply just sits between the vial as well as a syringe and it gets straight into the saline bag which then gets instilled into the patient's bladder so once you have that system set up uh you know if you have a hood great you could use a hood if you don't have it you could do your proper benchtop prep using the closed system transfer device. So we rolled this out during COVID and it was really well received by a lot of physicians.

Faisal Krashid, Analyst — Jefferies

Got it. So no hood, is there any need for like clean room or like cleaning down the room after that, like anything like that?

Arthur Kuan, CEO

You know, just proper, you know, bleaching. You can put a bleach tablet in the toilet bowl as necessary. But again, based on the closed system transfer device, it's not being, the product is not exposed to the open air.

Faisal Krashid, Analyst — Jefferies

Got it. Interesting. And then with respect to the buy and build dynamics of this, to what extent are the Lugpa practices well-equipped to do that and comfortable with doing that, especially given the price tag associated with some of these, or the approved product at least?

Arthur Kuan, CEO

Yeah, so, you know, really, I think with TAR200 launch, I think that's really one of the best things that could happen for us anyway as a fast follower where they're out there driving reimbursement confidence at many of the accounts that we're also highly interested in serving as well. So I think certainly it's still the early innings for buy and build in this market segment, but it's certainly going to continue to grow.

Faisal Krashid, Analyst — Jefferies

Understood. And then can you talk to us about when you launch the product, how we should think about the time from launch to commercial reimbursement and revenues in the door with respect to things like J-code and some of the logistics associated with that?

Arthur Kuan, CEO

Yeah, so this product category, you know, in the first six months you get a mis-J-code, miscellaneous J-code. And then after which, after six months, you get a permanent J-code. So, again, we're looking at in real time how that dynamic is playing out, right? There's, you know, a product, you know, chemo gel product, right, the pretzel product. We're seeing kind of that dynamic pre and post J-code. Certainly, there's also, you know, the time it takes to get to NCCN as well. You know, a segment of the population, the TET1 patients, you know, would go on NCCN guidelines. once you have a publication right so those dynamics are very important to track early on got it great and then is there a possibility to do an EAP or have you guys contemplated that at all to get some of that earlier you know usage and familiarity yeah so so given that the product has breakthrough therapy designation as well as the safety and efficacy profile that we have we have launched an EAP program in the US we're not guiding any specifics of it but there's definitely a lot of enthusiasm around the EAP great so you guys have the pivot six data for intermediate risk NMIBC you guys have pulled up the timing guidance on that can you introduce us to the study design and remind us when you intend to have that data sure so pivot six is a trial that is entirely in North America it's 364 patients one-to-one randomized we're looking at patients with the broadest spectrum intermediate risk non-muscle invasive bladder cancer disease so this is based on the AUA SEO definition of intermediate risk disease What's differentiated versus others in the intermediate risk space is we include a subset of patients with high-grade TA disease that are less than or equal to 3 centimeters with a solitary lesion. And these are usually, or all of them, are newly diagnosed patients. And so this trial is looking at, in an adjuvant setting, looking at recurrence-free survival. So the treatment arm has TURBT followed by credosimagine, and then the control arm is just TURBT with surveillance. We do offer a crossover on the surveillance arm if they recur and want to access credo. Both arms allow for perioperative chemo, which is a single dose of chemo that you give after TURBT. The practice in the U.S., you know, maybe up to 30% to 40% of centers might be giving single-dose peri-op chemo. So we're stratifying for that to make sure it's balanced across two arms. And in terms of the high-grade versus low-grade, we are also stratifying for that to ensure that both arms are balanced. So the primary readout is recurrence-free survival. So it's going to come in the form of a hazard ratio. and what we've been telling investors who are very interested in knowing what the control arm might do well the truth is no one has done such a study like pivot six before us right that are like primarily enrolls in the u.s. that looks across the entire ir nmibc population so we'll be we'll be the first to show in terms of you know proxies and analogs that people can look at You know, we've been telling people that the ATLAS trial could be one that could serve as a potential proxy. It's not the perfect proxy. There are certainly study design differences in ATLAS, but roughly speaking, between 12 and 15 months landmark, the control arm on ATLAS, which just had TRBT, did about 50% RFS or so. So we think that's a reasonable benchmark to look at for Pivot 6.

Faisal Krashid, Analyst — Jefferies

Got it. And what hazard ratio would you need to see to feel like you have a compelling profile in this setting?

Arthur Kuan, CEO

So given that there is no FDA-approved adjuvant therapy in this space, we believe, based on our discussions with KOLs before starting the trial, they want to see a 30% relative risk reduction.

Faisal Krashid, Analyst — Jefferies

Got it. And then given the timing of the rolling BLA where you've submitted your clinical module, you're working in some of the manufacturing and inspection side of it, but you're going to get this very important data in the near term, is there a possibility that you can fold that data into your ongoing BLA filing?

Arthur Kuan, CEO

Yeah, so what we've been saying regarding that is there'll likely be two separate applications. We still believe that the BCG unresponsive filing would be completed first, and then we'll follow on with a separate filing for the intermediate risk population.

Faisal Krashid, Analyst — Jefferies

Got it. And can you just clarify, like, what is the reasoning for that? Because, you know, I think some of the KOLs are, you know, super excited about this and wondering or hoping if this is a – like, this is something that I heard from a KOL, actually, not even an investigator. Yeah, so – Not even an investor.

Arthur Kuan, CEO

Yeah, so I think one of the things that we've said is since we completed the last patient who enrolled into Pivot 6 around Q4 of last year, we've stated that we believe we need at least 12 months of follow-up in all patients before we can, you know, pursue a filing there. So certainly, you know, the timing could be relatively close to each other, but there still will be a sequential approach. right in this case understood and then when should we expect that data when should we expect that data so you know we've said on may 8th that it could be available in the coming months got it okay i was almost hoping it would be today so we could talk about it live but we'll wait a few more it's an event-driven trial so again you never know exactly uh when that you know final events are going to occur yeah makes sense and then in terms of commercial readiness tell us about you know your your level of commercial preparedness how many reps do you think you'll need how many sites you need to be able to get into etc yeah so the focus this year is really just on account profiling and really understanding our accounts at a very deep level who are the key decision makers what were their experiences with prior branded products what did they choose are they on gem dosi what would they give after gem dosi right these are the insights that we continue to gather to just have a very in-depth picture of all the key accounts that we plan to go after in the early phases of the launch in terms of field force if you look across the space you know given the concentration of accounts everyone is sort of landing in the 50 to 75 kind of

Faisal Krashid, Analyst — Jefferies

field force number and we believe we like who would be in that similar range as well at risk of asking this question was like four minutes left there is a very active competitive landscape I know we talked about the other approved options or a couple of them in in BCG unresponsive high-risk NMIBC in terms of the development stage landscape can you just tell us like what are you focused on what do you see as credible competitive threats and and how do you believe credo stimogen is positioned yeah so look I think there were there was a non-viral competitor I think you know we still believe that MOA is very important I think certainly we're keeping an eye out on you know novel

Arthur Kuan, CEO

chemo approaches that you know could potentially increase its PK right but But ultimately, I think what puts us in a very strong position is how fast we're developing our follow-on indications, our moving the space into intermediate risk, which are all BCG-naive patients, as well as BCG-exposed, right? I think the future is going to mainly lie in BCG-exposed. Unresponsive gets us the first approval, but BCG-exposed are all these patients that fall outside of the unresponsive type definition that was set by FDA so we think there are at least 50,000 patients there and so we're in a position relative to the competition to make investments in that area first and that's with our cohort CX data which is one of the cohorts in core eight we looked at credo plus gemcitabine combination right and in that study we already showed at least in the valuable patient population a 92% complete response rate. And we also enrolled some unresponsive patients in that trial, and we found that there were no real differences between unresponsive and exposed, at least in that study, right? So if you think about it, the benchmark for CR rate mono versus combo with gemcitabine, if you just look at bond 3, the CR rate at any time was 76 percent. And now with the combo, we brought it to 92 percent. So to us, that's very exciting if that continues to hold up at, you know, for example, 12 months, which we're going to have data for later in the year.

Faisal Krashid, Analyst — Jefferies

Got it. And that will be an update from the data that you had at AUA? Okay, cool. So I'd like to kind of wrap up with a question like this. So you're going to have a bunch of investor meetings today. As you think about it, what is the one investor question that you wish you didn't have to answer anymore? People ask, and you're like, man, I don't want to answer this anymore. And what is the one investor question that you sit there thinking like, dang, I wish someone would ask about XYZ?

Arthur Kuan, CEO

Sure. So, look, I think, like, every meeting is about what's the benchmark for Pivot 6, what's the timeline for BLA, right? I think, I truly believe manufacturing is going to be CG oncology's core competency. And again, only time will tell, and we have to prove it to everybody, but to me, we will turn that into a strength, you know, in due course. i think i would definitely hope more people ask me about bcg exposed because i certainly really believe in that market got it and then maybe just one last one so you've had some leadership changes can you just characterize how you feel the company's position going forward sure we're definitely in a very strong position uh you know the board and myself you know we determined that it's important to have a chief commercial officer fully and solely dedicated to thinking through the launch strategies and launch preparedness into a, you know, we believe a very competitive launch, but it is a very large TAM, and we certainly want someone just, you know, focus on that completely.

Faisal Krashid, Analyst — Jefferies

Got it. Well, thank you so much, Arthur, for joining us. Really appreciate it. Thank you.