Lineage Cell Therapeutics, Inc. (AMEX:LCTX) Q2 2023 Earnings Call Transcript

Jack Allen: Great. Thanks again for taking the questions and the follow-up here. You just drive a thought as one of my peer was asking a question about Roche’s execution of enrollment of the OpRegen Phase 2a study. I know you mentioned in response to my question that you have a lot of experience with the sites that are being utilized by the collaborator. I guess, any historical context you could speak to as it relates to the ability of those sites to enroll patients in your Phase 1/2 study?

Brian Culley: One of the things that I likes to highlight some time ago was that the early forays into this study enrolled very slowly, in part because there were very few sites open and in part because these were the very first and incredibly courageous patients to receive this therapy. By the end of the study, this team at Lineage had taking control of enrollment. We had opened additional sites and we were able to enroll, I think the last four patients were all within a very crowded period of maybe six or eight weeks. So that is reflecting tremendous variability of pace of enrollment, which occurs not just at the study level but also at the individual site level. So I think there are some factors that go in our favor. In particular, I think the conversation between a prospective patient and the center and the surgeon is different today, because you’re talking about a program that has pharma credibility and 24 well — or highly accessible sets of data to be able to refer to rather than being the first of its kind, but at the same time, this is an optimization study, and I believe that Roche would like to minimize the number of variables to the extent it’s possible, so that they can gain as much information as possible from this study.

And in doing so, it’s not surprising to us that they have elected to start out with just the sites that we had used previously. I expect that that will expand over time. I don’t have specific information about that. But I think it’s a general sentiment that I’m encouraged that there is more horsepower and there is more experience available for this trial being run by Roche and Genentech than what was done in the hands of lineage, although, obviously, we were quite delighted with the finding some success that we had in our Phase I.

Jack Allen: Great. That’s great color. Thank you again for taking the follow-up.

Brian Culley: I appreciate that, Jack. Thank you.

Operator: Our next question comes from the line of Joe Pantginis from H.C. Wainwright. Please go ahead.

Joe Pantginis: Hey, guys. Thanks for taking the follow-up as well. So when you’re looking at the AMP 1 program, I wanted to dive in a little bit here. Can you describe, sort of, a little more of the models you’re looking at right now and what’s planned? And I, sort of, want to correlate that with the takeouts that you referred to Akouos and Decibel. Now they are using gene therapy, as you alluded to. They were very focused on targeting of their AAVs and in very specific mutations, which you don’t necessarily need do. So they were looking at animal models, in particular like Otoferlin models or what have you. What kind of models would you look to do to be able to address a broader hearing loss concept? Thanks.

Gary Hogge: Thank you, Joe. It’s a great question. I understand the question. We do plan to provide an update on ANP1 later this year. And probably the question is even more suitable at that time because at this point, our focuses and our emphasis is primarily on the delivery of our cells and the durability of our cells. As everyone knows, if your cells aren’t present, they’re not going to be functional, and that’s where we need to go. So we’re not at the level where we are designing our own functional tests or main comparisons to studies that have been done in the space. We really are just focused on stepwise progress here, which means ensuring that we can get the cells where we want them to go and ensuring that they are still present after a clinically relevant amount of time and using the models that are quite conventional in this space, which are various forms of rodent models.