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

Jean-Marc Bellemin: Yes, so thank you for your question Mark. So under the term of the agreement, we have two things that we will consider. But this will be a cash related activities, meaning we’ll have an upfront payment of roughly, we talk about $200 million. It’s exactly £167.7 million. That will be right away our cash at the time of the critical close. And then we will have a milestone that will be paid which will be roughly $50 million or £41.7 million at the time of the first approval of lifileucel in advanced melanoma. But those two events have to be considered as cash flow related activities not taking P&L, if you think accounting wise.

Mark Breidenbach: Got it. Okay. Thanks for taking the questions.

Operator: Thank you. And our next question comes from the line of Mara Goldstein with Mizuho.

Mara Goldstein: Great. Thanks so much for taking the question. With respect to the ATCs, when you in your commercial plan, how quickly or what is like the time or the lag for ATCs to begin to treat patients once product is approved? Does that commercial sale look like? Sorry.

FredVogt: Yes, so it’s very, very rapid, Mara. It’s something that they can do very quickly. We have the ATCs stood up. In fact, I visited one last week and saw how ready they were for this. We have a great team and Jim’s team as well as our medical affairs team and our ATC operations team are out there making sure that the sites are ready to go as soon as the product’s approved. So it’s something that the structure will be in place. The financial side will be in place, the operational side will be in place. Everything will be ready for the launch as if it was a traditional, like a launch of the CAR-Ts.

Mara Goldstein: Okay. And if I could just ask another question. Given, there are trials running, also in melanoma, although obviously different, I mean, are – the ATCs competing also for clinical trial patients?

Fred Vogt: No, we don’t really see that as a major limitation right now for us.

Mara Goldstein: Okay.

Fred Vogt: That’s really not. Yes.

Mara Goldstein: Thank you. I appreciate it.

Operator: Thank you. And our next question comes from the line of Asthika Goonewardene with Truist.

Unidentified Analyst: Hi, this is Karina for Asthika. I had a question on the TILVANCE-301 study. Has the first patient been dosed yet? And how many sites do you guys plan to activate? Thank you.

Fred Vogt: I will announce when we randomize the first patient hasn’t occurred yet, but it’s hopefully quite imminent now. And we’ll talk about that as soon as we can. We haven’t disclosed the number of sites yet, but it’s going to be a large international trial. So you can assume it’s going to be a very significant number of sites.

Unidentified Analyst: Okay. And you said it’s going to be outside of the U.S. primarily, or what’s the percentage are you looking at?

Fred Vogt: We’ll have a lot of U.S. centers and we’ll have European centers, Australian centers we intend to go elsewhere. Beyond that, it’s going to be a true international intercontinental study. I don’t know the percentages yet. That’s something that we’ll establish as we go through the course of starting up a large international trial like this.

Unidentified Analyst: Okay. Thank you.