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

Mark Forman: And the second question was regarding the registrational output. And we will be having ongoing discussions with the health authorities to define the endpoints that will be used for these studies and we’ll certainly provide updates on what those are as they come defined following our discussions with health authorities.

Omari Baruti: Okay. Thank you so much.

Operator: Thank you. And our next question coming from the line up Laura Chico with Wedbush. Your line is open.

Laura Chico: Good morning. Thanks very much for taking my questions. The first one on GM1 how do the inclusion criteria changes impact potential labeling? I guess what I’m asking is would this still be something that would be applied more broadly to GM1? And then in terms of perhaps a preclinical question, we’re hearing about more constraints on NHP supply chain issues. I’m just curious how that might impact some of the preclinical efforts that you’ve got going on right now? Thank you.

Will Chou: Okay. Sure. In terms of inclusion criteria, as you know any protocol amendments we make are subject to regulatory review. So, we will be happy to share the details of the inclusion criteria changes after that review is complete. What we have said previously is we’re looking to treat patients who are earlier on. And as you know all GM1 patients pass-through earlier stages, and our goal is to identify and find these patients at an earlier stage so we can maximize the risk-benefit of the product. In terms of patient identification what we do know is from the patients who have been suggested for the trial who have been given to our adjudicator we know that there are many patients who fit our new recommended inclusion criteria for the protocol. And so we feel confident in our ability to recruit these patients. Mark?

Mark Forman: So the second question is around impacts to our preclinical programs in terms of non-human primate availability. And our preclinical programs are done in collaboration with the gene therapy program at the University of Pennsylvania. And to-date the availability of primate has not impacted any of the ability of any of our preclinical pipeline to advance. So not an issue right now, but certainly it’s something that we’re carefully monitoring and we’ll be working closely with our colleagues there to ensure that that doesn’t hold things up.

Laura Chico: Thanks very much.

Operator: Thank you. One moment please for next question. And our next question coming from the line of Neena Bitritto-Garg with CitiGroup. Your line is open.

Unidentified Analyst: Hi. Good morning, guys. This is on for Neena. Two questions from us. First being on PBGM01. Can you disclose what the higher dose is? And if not perhaps how much higher in relation to the current dose that you’re looking at? And second in relation to PBFT02 we recall that you guys had patients in the queue last quarter? Any reason why these patients do not get dosed, and have you guys dosed the second patient yet? Thanks.

Will Chou: Sure. So for — let me answer the first question. So for GM01 as we mentioned before the protocol changes are subject to regulatory review. So as soon as that review is complete we would be happy to share the new dose. In terms of PBFT02, we indeed have patients in the queue. We have GRN positive patients who are at sites who are being queued up for future treatments. In terms of dosing, we are not providing specific details on patient-to-patient dosing within each cohort.

Unidentified Analyst: Got it. Thank you.

Operator: Thank you. One moment please for next question. And our next question coming from the line Yun Zhong with BTIG. Your line is open.