CTI BioPharma Corp. (NASDAQ:CTIC) Q4 2022 Earnings Call Transcript

Gil Blum: Good morning, everyone and congratulations on the progress. Maybe you could remind us how many patients are cytopenic on diagnostics?

Adam Craig: Jim?

Jim Fong: Yes. So essentially, you said at diagnosis, right, Gil?

Gil Blum: Yes.

Jim Fong: Yes. So at diagnosis, approximately a third of patients will have platelet counts less than 100,000 and at diagnosis of probably about 40% of patients will have anemia without thrombocytopenia.

Gil Blum: Got you. And over time, that generally increases because of disease progression?

Jim Fong: Absolutely. Absolutely. Yes. In fact, you’ll see over time, when you look at data, about two thirds of patients will have platelet counts less than 100,000.

Gil Blum: My second question is regarding guidance, and I know it wasn’t provided in this quarter, but I’m curious as to what gates a decision about providing guidance? Thank you.

David Kirske: Thank you, Gil. We’re not going to provide guidance at this time. We were ready to provide guidance. We will let you know one of the factors we’re looking at is gross to net at the moment. And as we’ve spoken about publicly, the gross to net is still somewhat variable. Until it stabilizes, we’ll refrain from providing guidance.

Gil Blum: Thank you. That’s very helpful.

Operator: Thank you. Our next question comes from the line of Reni Benjamin with JMP Securities. Your line is now open.

Reni Benjamin: Hey good morning guys. Thanks for taking the questions and congratulations on the quarter. Adam, I guess I’d like to stick with the ACVR1 data that was reported at ASH. I’m kind of curious as to what are the next steps, right, for the company? Is there any way to €“ like what would be required to get this into the label? And how do you see this data ultimately being utilized from a commercialization effort?

Adam Craig: Yes. Well, first of all, the anemia data is a post-hoc analysis. So it’s unlikely that the clinical data would get into the label. However, the mechanistic data, the ACVR1 arm, the pharmacodynamic and pharmacokinetic data around that, it may be possible to get that label, and that’s something the team is working on. Moving forward, it’s an important component of our scientific education of physicians through our medical science liaisons. It’s not a data set that we €“ Jim’s team can actively promote but we can discuss it scientifically. And in 2023, we are expanding the number of medical science liaisons we have in the field so that we can continue the conversation around the ACVR1 data. After ASH, we had a lot of inbound interest and a lot of requests to discuss the data with us, and that’s why we’ve increased the number of people who are able to do that. That is the medical science liaisons.

Reni Benjamin: Can you just provide some additional color? How much would you tell us the increase will be for MSLs and just kind of reading in between kind of the €“ what you said, I just want to confirm you won’t be starting some sort of a larger study, let’s say to evaluate the anemia benefit, going forward it would really just be based on the data that’s been generated today?

Adam Craig: Well, the anemia benefit will be assessed in the PACIFICA trial. As with respect to how much I don’t have a number to give you there. Post ASH, we have had a significant amount of interest in the anemia data. It was a very successful ASH for us, and we’ve come out to that into this quarter with a lot of questions and activity and discussions around the data. So it was very productive for us scientifically.