Passage Bio, Inc. (NASDAQ:PASG) Q4 2022 Earnings Call Transcript

Yun Zhong: Hi. Good morning. Thank you very much for taking the questions. So a follow-up question on dose escalation. Have you got approval on dose escalation itself, or would that still be dependent on data from Cohort 4? And on patient selection, sorry if I missed this, but is the next patient going to be late onset or early onset, or are you going to explore both early onset and late onset patients with the high dose? And finally, I think you talked before about the developmental delay as a very critical factor affecting treatment outcome. But the two patients in Cohort 4 seems to have very short delay, but not by design. So are you going to look for those patients specifically with the short delay?

Will Chou : Yes. Thanks for the question. So in terms of dependency on Cohort 4, no, we are increasing the dose right now. We are moving to do that regardless of any results for Cohort 4. For the additional patients that we will treat at dose 3, the higher dose, we are going to be treating both early and late infantile patients. And then I’ll turn it over to Mark for the last question.

Mark Forman: Right. So can you just remind me again of the last question, make sure I understand it.

Yun Zhong: Yes. It’s about developmental delay. And you talked in the past that it seems to be a very critical factor affecting treatment outcome. And both Cohort 4 patients they have very short delay, but not really the intention — sorry, not really by design that it looks like it was accidentally they had a short delay. So are you going to going forward look for specifically patients with short delay to improve potential treatment outcomes, please?

Mark Forman: Yes. So the goal moving forward is we work — as we’re actively working to revise the inclusion criteria is to shift the focus to earlier stages of disease, as Will mentioned earlier with the goal of identifying patients who have the highest risk, benefit risk profile. And with the — so the current inclusion criteria would certainly not exclude those patients as you pointed out in your comments, but the goal will be to try to enroll more patients with that profile with the shorter delay going forward.

Yun Zhong: Okay. Great. Thank you very much.

Operator: Thank you. One moment please for our next question. And our next question coming from the line of Danielle Brill with Raymond James. Your line is now open.

Unidentified Analyst : Hey, guys. This is Alex on for Danielle. Just looking at past notes, I believe that for the GM1 program that the expectation was to have the end of Phase 2 meeting with the agency somewhere in 2023. But with the added cohorts when does that — when do you expect that conversation to take place? Are we looking more like a 2024 event?

Will Chou: What we plan is to go discuss the registrational pathway with regulatory authorities with data from the additional patients who are being treated at a higher dose. So indeed that will not be in 2023, as we plan on treating the first patients at this higher dose in the second half of this year.

Unidentified Analyst: Great. Thanks for the color.

Operator: Thank you. One moment for our next question. And our next question coming from the line of Whitney Ijem from Canaccord. Your line is open.

Whitney Ijem: Yes. Thanks for taking the question. I guess on FTD, so you mentioned the update later this year will be — will include safety and biomarker data. Can you remind us for the biomarkers? Is that NFL level? Are there others that we should be thinking about? And how are you thinking about target levels or what would be good in terms of this first dosing cohort in your view?