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

A – Jill Howe: Thank you for the questions, Madison. With respect to OPC1, we always look to minimize the amount of time between when we are clear to open a site and getting through the contracting process and actually opening a site. A lot of the time is regrettably on the site side, the legal and the contracting side. I think generally speaking, sponsors are good about turning around their documentation. But each site is its own animal and poses its own challenges. So we do as much as we can to start these trials quickly. I have no reason to think that we would benefit in any way by having a delay. So while we know that this will be a study at a small number of sites, we are going to do everything we can to be able to start very quickly after the 30-day clearing period has occurred, but there are some centers out there that won’t engage fully until you have an IND open.

And that’s very frustrating, but many others allow you to parable path with an expectation of when you’ll be ready. So it’s a blend. When you have a multi-center trial, you’re going to find different hurdles. But for us, the best answer is for us to preplan and be ready to hit the ground running to the extent possible with redundancy and parallel path work being done in advance of that 30-day period. With respect to the second question, I have no idea how long it takes to transfer a cell therapy production process to a big pharma partner, because we’ve never done it before. However, we have abundant faith in our manufacturing production team and their ability to train and teach skilled collaborators to achieve the work as probably everyone on the call knows, manufacturing cells consistently and reproducibly and controlling the process is very difficult and there have been many failures over the years in laboratories around the world, but we have seen many examples of extraordinary success by our in-house manufacturing team.

One of those examples I spoke to with ANP1 being able to create a differentiation protocol very quickly. Another example would be the enormous scale of production, which they achieved with OPC1. A third example would be how well they were able to improve the purity and the scale of the OPC1 program — excuse me, I misspoke, I meant OpRegen previously and an OPC1 in that case. So those are three examples from three different programs, which illustrate the capabilities of the manufacturing team. And I have no reason to think that Roche and Genentech has a paucity of resources or capabilities quite the opposite. I expect that they have abundant capabilities in this regard. So while it’s not a straightforward and simple task, you can’t mail it into somebody, you don’t just send them a document.

You really need to be sitting next to the going through repeating it several times. I really am unable to tell you when I think that process would be completed, but we will pay great attention to it and work very closely with our partner to give them the best possible chance of success.

Q – Unidentified Analyst: Got it. I appreciate the color.

A – Brian Culley: Thank you,

Operator: Our next question comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.

Michael Okunewitch : Hey, Brain. Thank you for taking my question and congrats on the progress this quarter.

Brian Culley : Thank you, Michael

Michael Okunewitch : I think to start off, I’d just like to ask a little bit about the VAC2 program and to see if you could kind of prime us for the full data from that study with the additional analyses ongoing at your UK partner, which of those particular analyses do you consider to be the most important for both validating the platform as a whole as well as the VAC2 program itself.

Brian Culley: Thank you, Michael, for the question. I will refer to Dr. Hogge to respond to you.