Sam Chang: Hi, my name is Sam Chang. I'm a urologist in Nashville, Tennessee. And we really have the privilege and honor to have Dr. Max Kates from Johns Hopkins. Max is obviously one of the true leaders in urologic oncology with a focus on urothelial carcinoma.

He presented actually at this year's AUA in 2025 in Las Vegas, a trial in progress, actually looking at cretostimogene in the trial, looking at use of it in a different patient population than before. So tell us a little bit about the trial that you presented.

Max Kates: Thanks so much, Sam. So this is really an exciting trial. It's unlike all of the trials we've had in non-muscle invasive bladder cancer in the high-risk, non-muscle invasive space for patients who recur after BCG, which are primarily single-arm trials. This is actually a randomized trial. And so at this point, in bladder cancer and urology, we're getting really excited because we're finally starting to see randomized trials.

And so this is a trial of patients with intermediate risk, non-muscle invasive bladder cancer. So that's primarily those low-grade noninvasive tumors, some very small, high-grade non-invasive tumors, which the urologist will do a TURBT. And then we'll receive an induction treatment of either cretostimogene weekly for six weeks or observation.

Sam Chang: Got it. So it's a surveillance arm, which is what we do commonly now in these intermediate risk patients, versus six weeks of receiving cretostimogene. And the endpoints for the trial are what, Max? What you presented.

Max Kates: So the primary endpoint is going to be event-free survival. And so obviously, that will mean that we'll need to see how many events happen in order to see when this trial will read out. But that's going to be the primary. And an event is going to be any recurrence, for example.

Sam Chang: I mean, obviously, a very important trial. You're obviously leading the important British trial looking at, again, a comparison, but in a different patient population. But to have actually a randomized trial really will help us answer the question of the benefit of an intravesical therapy, compared to surveillance. Tell me—how is enrollment going? What do we look at in terms of the future with this trial?

Max Kates: So enrollment is going incredibly well. And I think it's for a couple of reasons. First and foremost, this is one of the primary trials of the SUO-CTC, which is a large group of urologic oncologists that have come together to run trials collectively with industry. And I think that's probably the main reason it's enrolling so well. But there's others, including the fact that, listen, this is an incredibly common disease population. These are patients that generally urologists see every day in the clinic. And it's patients that there's a major unmet need with no obvious treatment paradigm right now.

Sam Chang: So for this PIVOT-006 trial, are we still trying to—make sure I have the right number, is that correct?

Max Kates: That's correct. You got it.

Sam Chang: We've got so many different names. But with this trial, are you still recruiting sites to open patients or are you all finished with that at this point?

Max Kates: No, absolutely sites are still being recruited. Certainly, patients are still being recruited. I think when you look at these trials, what you often find is that the last month of enrollment is the highest month of enrollment if it's a successful trial.

Sam Chang: As the buzz gets around, it's like, look, what we have is an opportunity for patients and obviously the momentum. And with the SUO-CTC backing, the importance of—actually, for these patients, just as you said, we hadn't had really a lot of trials with this patient population and in a randomized setting, really, I think sets it up for helping us to answer the question.

When you look at the overall picture for these intermediate risk patients, how do you right now try to determine what's the best step for these patients? So some of these we consider chemotherapy, some—at times, if they're high grade, we think about BCG. So there are lots of things out there. What do you do currently for these patients?

Max Kates: I think it's—of course, any question like that is now under the unfortunate issue of a BCG shortage. So in my practice, historically, for those low—those small, high-grade noninvasive tumors, I would give all of those patients BCG. But now, my center, like many centers, is experiencing a major BCG shortage. And so I actually do treat many less-than-three-centimeter high-grade non-invasive tumors more as intermediate risk, and will consider either intravesical chemotherapy or surveillance alone.

Sam Chang: Careful surveillance. I agree with you. I think with—I hate to use the word rationing or prioritization—but we really are in the age where we have to try to determine what's the best treatment choice for those patients when we have limited supply. And so I think for those intermediate risk patients that you say, some of them we do surveillance—even knowing the chance of recurrence is really real, fortunately, the chance of progression seems to be relatively low in that population.

So Max, thank you very much. That trial in progress is really, I think, the lifeblood of our future findings, obviously in urology, and to have that momentum. And with the SUO-CTC backing, I look forward to having you present the results in the near future.

Max Kates: Thanks, Sam. It's always a joy to talk to you.