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

Reni Benjamin: Hi, good afternoon guys. Thanks for taking the questions and congratulations on the filing and all the progress. Fred, can you talk a little bit any and all interactions that might be occurring between you and the regulatory agency, kind of between now and the acceptance of review. Does – do you get a sense as to maybe how things are going? Or is there any back and forth that takes place before they kind of give you the thumbs up that it’s ready for review?

Fred Vogt: Yes, there’s been – there’s been – on FDA’s end, they seem to be very, very interested in BLA. There’s been a lot of good engagement. It’s really – it doesn’t enter the review process until after acceptance, but at this stage, I can say what I can tell you, at least at the color level is they’re engaged, they’re interested, they’re asking about things that we think are important. They seem to be very interested in the clinical data, and those are all things that we take as good signs.

Reni Benjamin: Okay. And then I – maybe it’s a little bit too earlier to talk about it, but as we think about potential acceptance and then there’s the manufacturing site visits and things like that. I’d love to get some sort of commentary on what you think would be the most ideal label for you guys to negotiate and versus maybe what might be a base case label that you’re thinking about.

Fred Vogt: I think the best label for us would be to include both Cohort 2 and Cohort 4. I think we’ve talked about that before. We’ve – we’re seeking that. We think that there is a good possibility for that. As we go through the review process as well as the inspection process because we have multiple manufacturing facilities involved, there could be questions and things that we have to do to adjust FDA’s comments. I don’t – right now we don’t anticipate that. We’re preparing to have a nice label that includes 153 patients from two plus four the full dataset that we talked about at SITC last year. That’s the ideal case. And I think that’s also the base case. I mean, that’s really where we’re at. It’s possible, as I said, in many, many earnings calls now, we’ve said possible they may put four, give us four on the label, followed by a section on two.

They did imply more recently that they would consider the pool cohort on there as well. So that’s a third option to be part of that.

Reni Benjamin: Great. Thanks for taking the questions and good luck.

Operator: Thank you. And our next question comes from the line of Mark Breidenbach with Oppenheimer.

Mark Breidenbach: Hey, good afternoon. Thanks for taking our questions. Just a couple quick ones for me on the pending Proleukin acquisition. Can you remind us if that deal comes with any sales personnel specifically with experience in promoting Proleukin and maybe it would be helpful if you kind of spell out for us how the upfront payment of Clinigen will be recognized on your P&L as well as the potential milestone that would come with lifileucel approval. Are these going to be kind of like lumpsum payments or they can be spread out of it? Thanks for taking our questions.

Fred Vogt: Right. I’ll take the first one then Jean-Marc can talk to you about the P&L. Yes, we are getting Proleukin people, Clinigen people as part of the deal. And we’ve also gone out, we’ve hired some people that have experience in this area as well. So we think we’re going to have a fully staffed team in commercial medical affairs and beyond. Proleukin including on the manufacturing side, we intend to have the expertise to keep the product rolling and also support the expansion of the product as lifileucel launches in the U.S. Jean-Marc, do you want to talk a little bit about P&L and how we’re going to recognize the expenses?