UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2022 Earnings Call Transcript

Mark Schoenberg: Sure. Thanks for the question. The answer is that we will be releasing the data from the TUR arm as well. I would caution everybody to remember that because the study is underpowered, we will not be able to compare the arms. However, it will give us a sense in this cohort of the performance of surgery and probably as or more importantly safety issues around surgery in this population, which is an area of some interest in study in our community right now. And then secondarily in the 102 arm, I think we have said on multiple occasions we will be providing complete response and durability data as well as safety data for that group of patients. And with caveat, again about not being able to compare arms, we do believe that given the substantial comparability of this population to the OPTIMA population reported in our Phase 2 experience, we believe that it will be supportive and directionally in line with what we’ve previously reported and what we would expect to see in the ENVISION cohort as well.

Liz Barrett: Yes. So I’ll just add two caveats, right. The €“ our OPTIMA II study was only 65 patients. Typically, if you look at clinical studies and look, I haven’t seen the data, so I have no idea. You typically see somewhat of a decline, right, in efficacy, because you have a much bigger patient population. So we’ll see. But we believe to Mark’s point, that it will be that will definitely be aligned in that case. The other thing is that just to also want to caution everybody on the data that we will share, because we will share top line data. But we will not share all of the data, mainly just because we want to get a publication, a peer review €“ in a peer review journal, and we want it presented at a meeting. And that if we give all of the data, that won’t happen. So we will give top line data, we won’t go into all of the details. But we will get that out in a paper as a presentation as quickly as possible. So thank you for the questions.

Unidentified Analyst: Yes, thank you very much. Just on UGN-102, the at home administration, do you plan to run an additional trial for this? Or like, is this more so going to be just for physicians to see and potentially then use if they need to?

Liz Barrett: Yes, we’re not planning to run another study. I think from our perspective, there were a couple things, right. We were in the middle of COVID, when actually it was our Chairman, Arie suggested it. You are hearing a lot more around, frankly, home is a hospital I think is coin a phrase that we’ve heard, bringing it home and we think that there’ll be an opportunity in the future, but reality of it is, is that most patients, and then we even saw that even in that study, most patients want to go into the doctor’s office, and so, but we do think, maybe in nursing homes and there’s opportunity. So I think we’ll see what the demand is for once 102 is approved and absolutely we could support an investigator-initiated study in bigger study.

But the likelihood of us doing a large study to go after an approval, I would say probably not very likely. But I think the data will allow, I mean, there’s not going to be anything in our label that wouldn’t allow for home delivery through a nurse, a home health nurse, just like they get other things through home health today. So I’m not sure that we need a study to be able to do that.

Unidentified Analyst: Great. Thank you very much.

Liz Barrett: Thank you.