Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q1 2023 Earnings Call Transcript

Prakhar Agarwal: Okay. And second on ARO-APOC3, any comments on how you are thinking about the trial size and duration for the CV outcomes trial? And what do you think you need to show on the CV outcomes for that asset to have a broad uptake in the smash population? Thank you.

Javier San Martin: Yes. Well at the very beginning of that process, as you know, it’s not a simple process. We will work with a group of experts. We are at the beginning of establishing the governance on how to design and execute that study. As we said during this call, we are wrapping up the Phase 2 study within the next quarter or two quarters, that will be the way that we will define the study design. We are planning to have interaction with the FDA to talk about that this year. And the expectation is that we will start this study in 2023. So, the beginning of the process, a lot of work that needs to be done. Some important decisions that will be related to the specific of the study design, how loading will last. It’s likely to be of course, an event-driven trial as most of these studies are. So, a lot to come, I would like to talk about it in the next few quarters.

Christopher Anzalone: There are at least a couple of things that are gating for us to figure out what those CVOTs might look like. And one thing is, look, we still haven’t read out the entire Phase 2 studies yet. We have interim analyst that looks quite positive and we are excited about. But we need to finish those studies and see what those look like. That’s the first. Second is that we haven’t had discussions with the FDA about their expectations. We have to have those. I think once we get through those two issues, we will have €“ we can have a better idea about what these things might look like.

Prakhar Agarwal: Understood. Thank you for taking the questions.

Operator: Thank you. At this time, I would like to turn the call back over to Dr. Chris Anzalone, President and CEO, for closing remarks. Sir?

Christopher Anzalone: Thanks everyone for joining us today and have a nice evening.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.