Lineage Cell Therapeutics, Inc. (AMEX:LCTX) Q4 2023 Earnings Call Transcript

It won’t be conclusive on its own, but it sure as heck is going to create a lot of questions, and some of those questions will include what the addressable market could look like if you’re able to access individuals, whose injuries are more than three to six weeks old.

Michael Okunewitch : Yeah. So just on the assumption that if you do end up getting some strong signals in the chronic setting, is it something where you might consider then working off into a parallel program looking at both subacute and chronic — or do you think for now at least, the plan is just to move forward to subacute after that?

Brian Culley : I think not having seen that data yet. But if the data reflects what you just described, I think it would not be particularly difficult to find enthusiastic investment for that fork. So I would be delighted to be able to have that opportunity. And I hope very much that we do have that opportunity because it would be just earth shaking in the field.

Michael Okunewitch : All right. Thank you very much. And congrats on the progress this quarter.

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

Operator: The next question comes from the line of Julian Harrison from BTIG. Please go ahead.

Unidentified Analyst: Hi, good afternoon. This is Ray on for Julian. Thanks for taking our questions. And congrats on the IND amendment for OPC1 getting cleared last month. You touched on this earlier, but we were wondering at what point could a partner makes sense for the program?

Brian Culley : At what price, Ray? No, I don’t answer that. But I think that my philosophy with respect to partnering has always been that there are points at which you may be able to get superior economics relative to other points. And to be a little bit more detailed, I think being able to show a partner that you have an excellent process of manufacturing yourselves and an excellent method to deliver the cells and perhaps even concurrence around a study design, although that one is less — that one’s more debatable, I think that could be an optimal time. However, partners that come in and offer compelling economics can get companies to change their mind about the right time to do that, if at all. Spinal cord injury is an orphan condition, and it’s not like every pharma company in the world has got a spinal cord cell therapy, commercial sales team that they need to have an asset for.

So the population of partners is more narrow but perhaps more dedicated. So it really is a fluid situation, and it has to also reflect our own share price and our thoughts on continuing to advance programs, without sharing the upside and if we’re sitting in an environment like we were in the last two or three years and a lot of people are looking at biotech unfavorably, doing partnerships makes a lot of sense. And look no further than the Roche agreement, I shudder to think what our situation would be had we not entered into that Roche agreement. And we’re fortunate that the economics of that deal were so favorable to the company. But we are entering a better period. And so that gives us choices. And I think that makes we, as the innovators more powerful in those negotiations.

So I’m sorry that I can’t necessarily put a pin on exactly a strategy of complete Phase 2b of x number of patients and then seek a partnership because we approach value creation a lot more fluidly than that. But I do think that going to a potential partner and saying, I’ve solved these problems is a more interesting proposition than saying, I have a program that’s available, but it has these problems. And I hope that answer makes sense.

Unidentified Analyst: Yes, that’s very helpful. Thank you so much.

Brian Culley : Thank you, Ray.

Operator: The next question comes from the line of Joe Pantginis from HC Wainwright. Please go ahead.

Joe Pantginis : Hey, guys. Thanks a lot for taking the follow up. Brian, I want to go back to your — one of your earlier highlights going back to OpRegen, and that is with patients, obviously, having a lot of the own personal variability with the what their dosing and what their geographic atrophy looks like. So it’s highly variable. I’m glad you highlighted that. So with that said, as we look towards Roche getting to a pivotal and commercial process, and you combine that with sort of the area being a relatively small surface area and eye docs have a lot of expertise in injecting the eyes, what do you personally feel or the company personally feel the level of the rate limiting step that getting the instruments and the methods down pat?

Brian Culley : I believe that it’s reasonable to say that there is no end to innovation and investigation of that matter. We have a baseline. The baseline was the time at which we entered into the agreement with Roche and Genentech. And we had 24 treated patients, one compassionate use of 25 treated patients, 7 using a suprachoroidal delivery device, the rest using a standard vitrectomy and retinotomy approach. And that was data that obviously supported a nearly $700 million deal. So it was a good starting point. The question, I believe that you’re asking me is what — how far do you — how far can you go? What do you want to improve? And I would presume, without being able to speak for our partner, specifically, this is, as you asked, my view, I would presume that they would be looking at both benefits, as well as risk.