Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2022 Earnings Call Transcript

Fred Vogt: Yes, I mean, I can cover that one. We have additional lung studies running right now, including the LUN-202 study, which could potentially read out this year. Plus, we already put out just a few weeks ago the 3A data and we do want to get to a medical conference and draw on that data a little bit more deeply. So that will be I think a very important presentation for the company when that comes.

Mark Breidenbach: Okay, all the presentations will be in lung is what you are implying.

Fred Vogt: No, not necessarily. I thought you were just asking about lung.

Mark Breidenbach: No. no. I am trying to go for all other indications as well.

Fred Vogt: Yes, there is other €“ well, I can’t say for sure what we are going to do, but we’ve got a pretty thick pipeline and there could be other presentations, other indications for sure.

Mark Breidenbach: Alright. Thanks.

Operator: Thank you. 074Our next question comes from the line of Tyler Van Buren from Cowen.

Unidentified Analyst: Hi, guys. It’s Tara for Tyler. So I guess staying on the same topic of the lung data. So I know that when you just closed that few weeks ago or back in January, that it was too early to comment on response duration. But what do you kind of expect to see when the full results are presented? And then how are your discussions with the FDA going following that positive feedback that you received on study 202? Like, is there anything new to report there since January? Thanks.

Fred Vogt: Well, on the assuming the LUN-202 study?

Unidentified Analyst: Yes.

Fred Vogt: Yes, that’s one where we are engaging with discussions with the FDA. I don’t have any updates for you on that right now. Well, on 3A we are €“ like we said, when we released the data, the durability is something we are going to watch closely and it will certainly be part of our medical meeting presentation on that. I can’t really say much more about that ahead of time. That’s obviously important thing to the content of the medical presentation. We do it, but we are very comfortable that what we are seeing should support a potential registrational trial like the one we described in January. And we do €“ we are doing our best to get back to FDA with that proposal as soon as we can.

Operator: Thank you. Our next question comes from the line of Michael Yee from Jefferies.

Unidentified Analyst: Hi, guys. Thanks so much for taking the question. This is on for Michael. Given that you guys have reiterated the BLA submission for Q1, I just kind of wanted to get a better sense on, I know you guys spoke about it slightly, but just if you can add any additional color on like the progress you guys made since the last update? And what are just remaining gating factors to getting that BLA submitted and also if you had any further interactions with the FDA since that last update as well? And based on the commentary that you guys have had with them, is there any color that you can share on a potential AdCom or priority review? That will be helpful. Thank you.