Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2023 Earnings Call Transcript

Friedrich Finckenstein: Yes, I totally agree. We have interactions with sites and investigators across all of the regions that we were commenting on in our presentation. So we are not intending to intentionally go for one region over another one. We are working with all of these regions in the same way, and the activities are ongoing in all of them.

Peter Lawson: Got you. And then on the lung, just the data you’ll be sharing this year, how much data should we expect for, I guess, Cohort 3A?

Fred Vogt: I think, Peter, you’ll see something similar a little bit incremental to what we put out previously because we’ve had some more time, but it’s not going to be a huge increase in what we put out in January, but it should be significant data, obviously, since that data was, of course, very important. And I think when you see the additional data you’ll understand why we’re so excited about it.

Peter Lawson: Got you. Is there anything else we should be thinking about with regards to the BLA acceptance? Is that kind of an end of May kind of event or anything else we should be contemplating?

Fred Vogt: As an an end of May kind of event? No. I think, we’re in May right now. We’ve got a BLA acceptance that we just mentioned around May 26th. That’s kind of the big event for May. We put out some of the information about what we’ll be doing at ASCO. So you can see that in the press release today, but really for 3:00 a.m. for some of the other data releases, which you’re looking at the second half of this year.

Peter Lawson: Got you. Okay, perfect. Thank you so much.

Operator: Thank you. And our next question comes from the line of Colleen Kusy with Baird.

Colleen Kusy: Good afternoon. Thanks for taking our questions. So further confirmatory study TILVANCE has FDA suggested to you that a certain proportion of the study should be enrolled before they would grant accelerated approval? And if there hasn’t been any communication, do you have an internal goal for enrollment at the time of approval?

Fred Vogt: No, they’ve never said anything about percentage enrollment. They used the term well underway with us, and they – in fact, they told us they were pretty happy when we presented the trial to them about our timing last year. So they have not given us anything like that. We do have internal targets for enrollment, of course. They’re quite aggressive, but we can’t – at this point, we’re not going to be disclosing those right now.

Colleen Kusy: Understood. Thank you. And I guess another question on enrollment, just this one on the cervical cancer study any update on how that enrollment is going and how quickly you could expect to file using that data?

Fred Vogt: Right now the study is enrolling quite well. Maybe Friedrich, you can take a little bit of this after I finish here, but it’s enrolling well. We’re – we don’t have really an update for you just yet. We just restarted the trial not too long ago. We are bullish about this. We’re very focused, obviously on the melanoma BLA first though. So I think after we pass the melanoma BLA, you’ll hear more from us about cervical. Friedrich, do you want to give any – give Colleen an idea of the – how the investigators feel about cervical right now and how it’s going?

Friedrich Finckenstein: Yes, maybe just as a – as additional color, I mean, given that we had to – that we had to restart this cohort because we had initially communicated that that we were holding enrollment and then we restarted it as we have shared before. I’m actually pretty pleased with where we are with the level of engagement by sites and investigators set the enrollment at this time. So it’s like it’s going well.

Colleen Kusy: Great. Thanks for taking our questions.

Operator: Thank you. And our next question comes from the line of Reni Benjamin with JMP Securities.