Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q3 2023 Earnings Call Transcript

That I think is the importance of this data.

Reni Benjamin: I guess just one final question regarding the label. Is there any possibility of a blue sky sort of scenario for a labeling discussion, where you get more than what you want? Or really, when we’re looking at this data, accelerated approval and the like, you think the base case scenario at least on the trial results from Cohort 3 and Cohort 4 is the best that we can hope for.

Frederick Vogt: Well, actually, let me say something, Raj, then you can add in because we didn’t answer Yanan on this full either. But on the label front, if we get Cohort 4 followed by pool Cohort 2 plus 4, which is what we think FDA is leading towards right now based on our conversations, we think that’s the home run, the best option because that allows promotion on the back of both the Cohort 4 data, the pivotal data as well as the 153 patient data set with mDOR not reached. It’s a large data set. It just gives you a lot of different promotional opportunities for the product. And Raj can tell you more about sort of integrity of the details of when the timing for labels and that kind of discussion comes up if you want.

Raj Puri: Yes. I think some of — Fred covered it pretty well. Some of the living discussion actually has begun. We have received a few IRs and we have responded to them. So as far as we’re concerned that labeling has started, and we have more discussions regarding that in the next couple of weeks or so.

Operator: Our next question comes from Mara Goldstein with Mizuho.

Mara Goldstein: If I could just return to the strategic portfolio prioritization as well as the completion of a number of activities, you mentioned that, that is likely to reduce the quarterly and annual operating expenses. So I’m wondering if you can provide us with some guidance at least directionally as to what that is. And then on the ATM program, how much capacity is left there?

Frederick Vogt: Jean-Marc, do you want to take that?

Jean-Marc Bellemin: Yes, definitely. Thank you, Mara, for the question. So I’m not going to be really specific, but you can imagine that this year, as we were preparing for launch there was a lot of onetime expenses related to manufacturing readiness even on the CapEx and OpEx front, also ramping up on the commercial all the activities and medical. So there was a lot of spend that occurred in 2023 that will be considered again onetime and not happen next year. So prioritization means also managing investment over time. And that’s why we’re confident about our ability to reduce our spend both quarterly and annually as we announced during the call. And on the ATM. Yes. So on the ATM, we still have a large amount available because we have a $500 million ATM on which we only had a partial amount in Q2.

Operator: Our next question comes from Asthika Goonewardene with Truist.

Karina Rabayeva: This is Karina for Asthika. I had a question if you could share some color on the manufacturing success rate, whether you had any discussions with the FDA on this and the potential for specs to be tighter in the commercial setting as has been previously seen with other parties.

Frederick Vogt: Igor do you want to get that?

Igor Bilinsky: I’m sorry, could you repeat the question, please, my audio broken up.

Karina Rabayeva: So on the manufacturing success rate, whether you had any discussions with the FDA and for the potential for the specs to be tighter in the commercial setting?