Conference Transcript - CGON 2026-05-20

Speaker 2

Final fireside of the day, we're really pleased to have CG Oncology with us, represented by their CEO, Amba, and their CFO, Jim. So thanks for being here.

Ambaw Bellete, CEO

Thank you. Thanks for having us.

Speaker 2

You guys recently had some data Friday and over the weekend, so I figured I'd start there maybe. How are you thinking about what you just presented in Cohort CX? How does it help further broaden the opportunity for Credo?

Ambaw Bellete, CEO

Yeah, I mean, thank you, Leo, again, for the opportunity to be here with you. I think when we looked at cohort CX and the design of the trial, we had a number of aims in that trial. You know, the first aim, obviously, we had seen some preclinical work on the combination of Credo-stimogene and gemcitabine, the fact that you can combine it together, and we wanted to see the potential of that in a different clinical setting. in the high-risk BCG-exposed particular setting as well as in the unresponsive setting. So the data that we shared this past Saturday and on Friday in a poster session at the AUA meeting in D.C. really was around that data. And one of the things that we observed from that data was that when you look at from an efficacy perspective, it showed a high relative efficacy compared to the other data sets that we've shared in the past. It was at least, when you look at the CR anytime, about 15 points higher in that combination. Again, two-thirds of the patients in this trial were exposed. The other third were unresponsive patients in this category. The other aim of the trial was to see and identify the right dosing schedule for that combination. We had both a concurrent schedule, meaning credosimagine followed by gemcitabine on the same day and same time. And also we had a sequential schedule, which was credo-credo-gem, meaning week one credo, week two credo, followed by week three with gemcitabine. And we wanted to see also the safety of those both regimen as well. So the results of the trial showed that it is safe, you know, number one, and both the concurrent and sequential arms of the trial had a relative similar efficacy as well that we shared. Again, we had, you know, only six-month data, and there's additional data that we'll have at a later time. But the signal was positive, and that positive signal will help also to inform us when we have additional data on a design for a phase three trial in the BCG-exposed patient population. We think that population, there's about 50,000 patients in that category. Exposed patients are patients that fall into the category because they didn't have adequate BCG. They didn't have the definition of 5 plus 2 in that case of BCG, for example. They are 12 months and a day later than their last BCG. Therefore, it's a unique opportunity for us in that underserved patient population to look at this type of combination strategy for those patients.

Speaker 2

Got it. As you think about the data, and I know it's early, but it's probably been some physician feedback. How do you think about it being applicable to the real world? I mean, was this a play for a higher initial CR? Do you expect the durability here to last as well? I know Credo alone has had pretty impressive durability. I guess, what's the goal for physicians if they choose the CX regimen over Credo alone?

Ambaw Bellete, CEO

You know, obviously, clinicians have an opportunity to utilize credostimogen the way they deem it necessary for their patients. You know, we're adding to the body of clinical evidence around unresponsive and now in the exposed patient population, and really to give optionality, because our goal has been always to make cretostimagine backbone therapy within this space. We have now data in the unresponsive setting, in the high-risk setting. We have data in the BCG-naive setting. We have data now in the exposed setting. And we expect data from our intermediate risk trial to also come on board, but really working to make credo-stimaging backbone therapy within this space. And any additional add-on therapies to that, depending on your risk stratification of the patient, could be an opportunity for clinicians to make that choice. But what we're aiming to do is obviously really increase the body wealth of clinical evidence. In different patient settings, therefore, clinicians will have that optionality.

Speaker 2

You touched on this briefly as you sort of alluded to thinking through a registrational path, but i guess what could a path for the cx cohort look like i mean is this something you'd run a full phase three in is this something you could you know achieve with guideline listing yeah we think we need to run a randomized trial in this area and that's what we hope this informs us of what that design ought to look like including the dosing schedule as well in this particular setting.

Ambaw Bellete, CEO

So we think a randomized trial will be warranted in this setting. And this randomized trial will cover not only CIS-containing disease, but also TAT1 disease, thereby giving us the opportunity to have that all labeled as well in that segment of the high-risk population.

Speaker 2

Got it. You know, one of the advantages of CREDO in principle has been that it's chemo-sparing compared to some of the other options. And is there anything you're giving up by using the CX regimen?

Ambaw Bellete, CEO

You know, that's one of the things that we are still investigating. You know, what is it? Side effect was one area that we looked at because we've seen the data of the combination of cretostimogene plus pembrolizumab, for example. And really, a lot of the side effects in that trial was related to the IO portion of it, pembrolizumab portion of it. We encouraged that in this data set that there was no grade three or higher side effects, for example, in that combination so far. based on our observation of the data. And that's really actually compelling because that really keeps to really the side effect profile of what monotherapy offered for patients on cretostimogy.

Speaker 2

I want to shift gears now to talk about an upcoming trial, PIVOT006. I guess, what's your latest expectations of the timing? And can you reiterate maybe how you're thinking about the effect size you'd like to see?

Ambaw Bellete, CEO

I think there's been a lot of questions around PIVOT-6 and the timing of PIVOT-6 that we've seen. And this is our trial of cretostimogene versus standard of care TRBT in the intermediate risk setting. This is actually going after the broadest label within intermediate risk NMIBC or non-muscle evasive bladder cancer as per AUA-SEO guidelines. There are other studies with other competitive assets that really cover smaller portions of that patient population. This will have the broadest label once we have data released from this trial in that patient segment and population. In terms of timing, what we've indicated is that we will have data from the trial in the coming months. You know, in our last update on May 8th, this is an event-driven trial. Therefore, it's really hard to articulate the exact timing and date of when you potentially will have a readout due to the event-driven nature of the trial from a design perspective. Mind you, this trial also enrolled really very quickly, about a year ahead of schedule. So therefore, when we estimated the time and we gave an update at the beginning of the year on the first half of 2026, it was really based on a lot of that information as well in terms of our patient enrollment status as to where we are with that trial.

Speaker 2

Got it. Can you just broadly touch on the effect size that you'd expect? I mean, there's, I think, a lot of the questions I've been getting is trying to triangulate what, you know, TRBT may do, you know, how much benefit is acceptable for physicians in the real world, considering that, you know, standard of care may not just be TRBT, but there might be some chemo layered So I guess, how do you think about the benefit you need to show over TRBT to not just be a positive trial, but also to be competitive with what, you know, real world practice may Yeah, I mean, I think what we've finally stated is a, you know, 0.7 is the number that we've stated publicly with respect to that trial.

Ambaw Bellete, CEO

And, you know, I think the other things that people have looked at is, you know, what proxy or other analogous type of trial that you can look at. And, you know, I think we've seen and stated that the ATLAS trial was showed a 50% at, you know, 12 months or, you know, is probably a good reference point to look at. And that's probably, the direction that we are looking at. In terms of this particular trial in itself and really what clinicians are not really caught up on 0.7, the hazard ratio of this, and so I know there's a lot of discussion around 0.7, 0.6, and those kind of things and so on, but that's not how physicians think about it. We spend a lot of time at the AUA meeting, for example, and speaking to a lot of physicians about the expectation around data and what it actually would take from an adoption perspective, or even, you know, really giving it to a patient as an option for intermediate risk. They talk about the following things. Does it work? How long does it work? What is the side effect profile of that product? Those are the things they talk about. Again, we are nearly 15, you know, 18 plus months ahead of any competitor within this There is no branded product within the broadest label within intermediate risk NMIBC. We really have a unique opportunity to create a new market, a new venue for the use of credo-stimid gene within this space.

Speaker 2

Got it. There's also some concern out there on, and this might be a good time to talk about the mechanism of credo, about whether the ability to target cancer cells or E2F-driven, if that's something that's going to be confined to high-risk subtypes or whether it can work broadly in MIBC. I guess, any thoughts on that?

Ambaw Bellete, CEO

Yeah, I mean, I think it's another question that we've been getting. I think I would go back to kind of, you know, how credo-stimaging works. So from a mode of action perspective, the dual mode of action, direct tumor lysis, followed by durable immune activation that leads to adaptive, you know, memory response. You know, what we've seen, for example, from the high risk data set that we've seen is that, you know, RB mutation, for example, is an important aspect of it. It's really, you know, 10 to 15 percent in that patient population. So really, that wasn't the only driver. There are other drivers that leads to the effect of cretostimogene. And also, when you look at our cohort P data in TAT1 patient population that we shared as well last year, it really is kind of analogous to the intermediate patient population with papillary-only disease that is in that particular setting. And really, the efficacy of cretostimogene in that patient population was high. Therefore, it gives us some level of confidence and insight to how it would look like in this particular type of setting. Mind you, intermediate risk on MIBC has multiple disease states, including high-grade disease, 2A disease, less than three centimeters. That's part of it. We stratified for those patients in our trial, therefore at about 30% from a CAP perspective. And we think that we look forward to sharing the data from the trial, but we think that, you know, it could be a positive outcome from that.

Speaker 2

One of the advantages of having a really broad population in IVIT is the ability, as you mentioned, to have a broad label.

Ambaw Bellete, CEO

I guess as you think about that, does the benefit have to be uniform across all the patient populations that are in that study? um do you expect that one group may perform better or worse i think it's hard for us without seeing the data to make that assumption um we don't think that there would be you know such huge differences between all of those um you know patient population but mind you i think if you have a newly diagnosed patient that has one single solitary versus a patient that has had multiple recurrences of disease, obviously those patients are likely to be a little bit different or that patient that has high grade less than three centimeters as well. So the heterogeneous nature of the disease in itself, you know, can result in what that outcome would look like is probably the best way to describe it. But we don't, I think it's very hard for me at this juncture without any of that information or data available to make assumptions as to how it would be. So, yeah.

Speaker 2

I guess bigger picture in MIBC, how do you think about the competitive landscape? There's obviously a new product that's recently approved, but there's also at least half a dozen other biotechs working on products in MIBC, and it's getting pretty crowded pretty quickly.

Ambaw Bellete, CEO

Yeah, I think you have to look at it disease by disease so when you're thinking about high risk for example you have you know four competitors currently in the bcg unresponsive segment you know with the products that are within that marketplace bcg exposed the patient population that i just mentioned you know there's not that many players within that particular space for example bcg naive all of the ios have tried to go into that space with the large trials that have been conducted. So they are distinct segments, although it seems crowded across the board, but there are distinct segments and distinct indication. Intermediate risk and MIBC, for example, you know, we're well 18 plus months ahead of the next competitor within that space. So we see them as distinct kind of areas in space. And really, I go back to what is our goal with predostimogen is really to make it backbone therapy within the space, addressing a total of 150,000 patients across intermediate risk on MIBC, about 50,000 patients in that category, followed by the BCG unresponsive, which would be our first indication we're going after, about 25,000 patients in that category. BCG exposed another 50,000 patients in that category in the naive patient population, about another 25,000 patients. So that's really our build, starting with the unresponsive, establishing a beachhead there, expanding to intermediate risk, then looking at expansion into the exposed. And each of those markets, to your earlier question and point that you just had, is uniquely different in terms of who are the players and what actually is the clinical management for those patients as well. And what's acceptable risk as well in terms of side effects instead of dosing scheduled dose or all kind of the mechanics of really that will drive uptake and success. Got it.

Speaker 2

Can you talk a little bit about actually giving credo in the clinic?

Ambaw Bellete, CEO

I mean, both from sort of the biosafety angle, but also from the administration is this something that you know high volume practices could have you know qualified health care professional do is this something that has to be done by the physician sure yeah yeah so i mean let me just talk to you about the the mechanics of it and maybe i'll back up a little bit about let's say you had a patient coming in this friday to your particular office you would have received the product on thursday or wednesday or even earlier in the week you can leave the product within the box take it out and put it in a normal refrigerator up to eight weeks or longer in your in your refrigerator and take it out prep time to the table is about 10 to 15 minutes you know to the table to get it ready it's a 2 ml volume it's a small volume of product that you're giving so that will be the prep time then you will actually give it in a any type of room. You don't need any specialized equipment other than a cath. You can administer it in any clinic room or room with a drape, an infusion center, any of those facilities, you'll be able to actually administer cretostimaging. And it's done by a medical assistant or a nurse that are able to, in a similar way as they're giving BCG. That's probably the biggest proxy, I would say. Also the PrEP, you know, question about the PrEP, whether you can do it on the tabletop. You can use a hood if you happen to have a hood. However you're mixing BCG today in your office, you'd be able to prep creatostimogene in a similar way. It wouldn't require a urologist. It wouldn't require a physician assistant. Any of those are not requirements for that. So it's DDM, which is instilled for about 15 minutes, followed by creatostimogene for 45 minutes to 60 minutes, so all in time, about an hour or so. That's the entire procedure, and those are the personnel that are involved in that procedure.

Speaker 2

I just wanted to touch on some of the manufacturing. We've heard at the conference as well about some of the challenges with BLA manufacturing. I guess where do you stand with your ability to scale up manufacturing and make this in a reproducible and consistent way?

Ambaw Bellete, CEO

Sure. Good question. It's one of the questions we've gotten a lot of in terms of CMC. One point I would make is for our first indication, you know, we have a capacity of about 50,000 vials at our current scale. Our clinical scale and our commercial scale are the same. That's a really important point because that's where some of the issues that have arisen is really when you're scaling up from a clinical lot supply version to a commercial lot and you're going up. So from a scale perspective, we're utilizing the same scale. So we're not changing any of that process. We're not making any changes to that approach. So that's one piece of the puzzle and the equation. We will scale up for future indications, but our first submission is going to be based on the same scale as our clinical scale that's treated well over 700-plus patients in all our clinical trials that we'll be utilizing for the commercial launch. and has a capacity of about 50,000 patients in that.

Speaker 2

Got it. Can you also then touch on the regulatory process? You've recently updated your guidance for, you know, when you expect to complete the BLA. What parts have been done so far? What's left to do?

Ambaw Bellete, CEO

Sure. Sure. You know, what we updated, you know, on May 8th, our update was that we've completed our clinical and non-clinical packages. We have one more module to complete, which is our CMC module. We intend to complete our filing, which is a rolling submission by the end of this year, and the fourth quarter is what we indicated. That's our plan. So part of that, obviously, you know, is really the work that we're doing at our fill-and-finish facility, BioVir, that we purchased last summer. And at that facility, we're in the process of doing the facility upgrades, upgrades to their quality management system, you know, moving from paper-based to electronic-based systems. We've also added additional staff and team members to the team and organization as well. We've conducted mock inspections as well across our network of, you know, partners that we work with to ensure that they'll be ready for a CBER inspection. This particular facility has undergone a cdrh inspection in the past by the device division uh just last year uh they passed without any observations from the agency but a cber uh inspection is a different type of inspection that requires a higher level of rigor and that's what we are utilizing ex-cber inspectors to actually ensure that this site is ready for that and that's what we're working on to finalize the package along with writing of the package for submission.

Speaker 2

I guess maybe just to follow up on that, anything you've learned from your inspections, something that's been going well, places that still need work as you work towards the BLA filing? I guess as we think about how close you are to finalizing the CMC portion, which inning are we in?

Ambaw Bellete, CEO

I think it's very hard for me to give more color than what I've shared, I think, on this topic. I know it's an important topic that people ask us about. I would say that it's going to plan, and that's why we've had a recent engagement with the FDA on this particular topic. they have you know listened to us about our approach that and that we're taking for submission and you know we've gained alignment that's why we're able to actually really uh given a tighter band in terms of a you know finalization of our package timing for submission and and in terms of articulating where are we in that timing you know i would say we're heading towards the fourth So we're kind of in that time broad band, I would say. That's probably the best way I can articulate it. Got it.

Speaker 2

Is there an ability to weave in the intermediate risk data with the high-risk filing?

Ambaw Bellete, CEO

What we've stated is that the filings will be sequential. So they share the same CMC data package. They share the same non-farm package as well. But the clinical data obviously will be different. What we've stated is that we will file for intermediate risk in 2027, sequentially after the completion of our first filing at the end of this year. It's also the reason why we're taking really, you know, the right steps to make sure that we have a robust de-risk package at the agency. because we're following our first indication with our second indication filing very closely to it, therefore ensuring that we have really the robust package that covers a gambit of 75,000 patients between BCG-owned responsive and intermediate risk and MIBC. That's the reason why.

Speaker 2

In our last minute, just wanted to touch on the commercial scale and PrEP. I guess all goes well, you know, have a filing in, you know, have an approval. I guess what launch readiness has been done, what still needs to be done, and how are you thinking about when to finalize those activities?

Ambaw Bellete, CEO

Yeah, I mean, you know, we really are excited, and we've been really working on pre-launch activities for the past year and a half. You know, we have a team of medical science liaisons that have been already in the field doing scientific exchange, engaging with our future commercial customers, already around our data. We've had a team of health systems directors that have already been in the field talking to the C-suite of the large volume centers throughout the U.S., the top 300 network sites around the country. We've had account executives calling on payers already well in advance to set the stage for our launch. And now we're in the stage of recruiting our sales leadership that will be managing our field organization as well. We have a stage gate approach in terms of a T-minus plan in terms of when we will bring in additional resources at the various stages. Our footprint, and which we've stated publicly due to really the size and the consolidation of practices and centers throughout the country, we expect a footprint around 75 individuals that will really be our launch team that we're going to be deploying out in the field some of which we've already already have in house meaning they're already uh with us and then complemented by field reimbursement working on reimbursement issues at the centers and accounts as well that's another aspect of the team that we already will have in place for that all of this is really uh working you know kind of in a sequential manner as we get ready to launch building our hub services, our reimbursement support services, all of those are going to plan.

Speaker 2

That's all the time we had. Thank you so much for this informative conversation.

Ambaw Bellete, CEO

Thank you for the invitation. Thanks again. Yes.