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

Gary Hogge: So their ongoing investigations are looking at biopsies from the tumors to look for tumor infiltrating lymphocytes. We’re keenly interested in those data. We’re looking at skin biopsies at the site of administration to see what type of cell influx occurred post first administration all the way up to six administrations. So that’ll be interested if that profile changes over time. Additionally, we’re looking at different laser panels. We look to see if we have a Th1 or a Th2 cytokine profile shift that wasn’t there a baseline. And all these would be indicative of a potential immune response to the antigens of interest and may show that there was at least some anti-tumor effect as well that we’re certainly interested in looking at. So those data are being analyzed and we wait to report from Cancer Research UK.

Michael Okunewitch: All right. Yes. Thank you for that. And then I would just like to ask about the — specifically in the auditory disease space, you have gene therapy going in with some pretty significant attention. Do you see having additional one-and-done therapies out there paving the way as making it more attractive for development for ANP1? And then do you have any additional color on specific indications you might look to go into once this gets towards the clinic?

Brian Culley: Thanks, Michael. I have a two-part answer. The refinement of the indication and the intended patient population will be driven by the data which we collect initially pre-clinically and then evolving into the clinic. It’s difficult for us with such a new approach to be definitive, to be incredibly definitive about how we see the best use of this intervention. And we’re quite aware that there are many types of hearing impairment, some of them chemicals, some of them physical, some of them more reflecting aging and degenerative processes. The notable aspect of other approaches and let’s call it, success that we’re seeing in approaches for hearing loss, I think, is very beneficial to our earlier program, because it’s beginning to establish the existence and refine some of those questions about what are the right clinical endpoints to use what are the economics of a program look like because, ultimately, if we’re going to get credit for what today is a preclinical program, that’s going to come through some sort of a valuation exercise, which is going to need to have some sort of an addressable market, which is going to need to have some refined patient population.

So while it’s exciting to go into a new area with an incredible paucity or dearth of other competitive threats, the trade-off for that is we don’t have a mature and established commercial market that we can point to with certainty and say we know exactly what patients we’re going after. So in light of the options of a mature and crowded space compared to this new area, I’m delighted to be going into this new area because we can partly define it for ourselves rather than be forced into following others, but I think there’s a lot to learn in the hearing loss space from some of the early forays that we are seeing, in particular, in gene therapy. And as I described earlier, even if a gene therapy is able to wonderfully address one specific deficiency in the genome through some sort of repair or replacement of that genetic information that is going to leave many other kinds of hearing loss available to an approach that is replacing the entire genome through the transplant of a cell.

Michael Okunewitch: Thank you. I appreciate your insight.

Brian Culley: Thank you for the question.

Operator: Our next question comes from the line of Jack Allen from Baird. Please go ahead.