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

And now it’s almost routine. So I think that the history of new technologies would suggest and indicate that improvements are possible. They require some investment and some work. But I am encouraged by the fact that the historic arc of scientific discovery would suggest that there will be improvements that ought to lead to improvements in clinical outcomes for patients.

Joe Pantginis : Appreciate the color, Brian. Thank you very much.

Brian Culley : Thank you, Joe for the questions.

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

Jack Allen : Great, thanks for taking the questions. And congratulations on the progress. A pleasant surprise today with the 24-month update around OpRegen, and I’ll start there and some of the comments you’re making around the preclinical model and the need to deliver these cells directly to the lesion or where I’m going to start with my first question. Any color as it relates to those patients? I know there were five from the first trial here that by happenstance had it delivered across lesion, how did they perform relative to the mean of 5.5 or must I wait until the second quarter of this year in the presentation to hear more?

Brian Culley : I appreciate your comment and your question, Jack. Thank you. All I can say, because I don’t want to take away any thunder from Roche and Genentech’s forthcoming disclosure of some of this information is that the patients that did receive OpRegen more fully across the area of atrophy on average did have higher, as a subgroup had a higher elevation in BCVA, compared to the 5.5 number for all patients. And I referred to that as is expected by me, expected by Lineage because we do feel that having the cells directly on to the area of atrophy, where the photoreceptors are hanging in there, not quite obliterated, makes a lot of sense. But I am trying to caution with respect to the — how tight, the correlation is, could want to imagine that delivering a bleb of OpRegen off center, compared to 30% on compared to 65% on and totally covering — then you have this beautiful correlation perhaps in theory, that is exactly what you would get.

But each patient’s area of atrophy is unique. They are fingerprints. Some of them are very rounded. Some of them have these large lows. Some people have very healthy Bruch’s membranes. So one needs to think about sort of the 3-dimensional characteristics of a bleb. And while we and I believe our partners agree that delivering the cells as closely as you can to the area of atrophy and getting as much coverage probably is the — is associated with the best possible clinical outcome, that’s not to say that people — that there couldn’t be someone who maybe gets 50% coverage and has a better outcome than someone that got a 90% coverage and for whatever reason, it did not. So there are multiple variables that are moving when we think about these patients.

But I think that we do have alignment that this is not a cell therapy that is exerting its effects at great distances the way that some of the systemic delivery of stem cells has aspired to in early iterations of these technologies. Instead, we believe in two things. One, that a differentiated cell type, i.e., replacing the actual cell type is one condition that’s required. And increasingly, two, delivering those cells directly to the place where they belong is also necessary for optimal clinical outcomes.

Jack Allen : Got it. Got it. And then just to follow up. You mentioned some of the external comparisons and the progression and some with some other mechanisms of action. But it’s my understanding that you did have an internal control here and that there were fellows that were tracked throughout the study. Any contextual evidence around the progression from those either of 24 months? And then I have one last one. I’ll just give it my try on the Roche data. How do you contextualize the cash runway into the third quarter ’25 and your expectations around the Roche Phase 2a data? Was that a strategic move to push beyond the Roche data? Or how should we think about that from a cash flow line perspective?

Brian Culley : With respect to the contralateral eye, that is one that you will need to wait for the second quarter to get details on. With respect to financing, although I understand that interpretation and I can’t sit here and reject it 100%, I do want to add for you and for everyone listening to this particular answer that there are many factors that go into a decision to raise capital. So that’s really the right answer. For example, to illustrate this point, if a company is getting down to approximately a year of cash and has a going concern, it might get flagged as attractive short for some investors. And so it’s nice, but not always required to avoid that. That is, again, just an example it happens to be unrelated to timing of Roche data, but it is illustrative of the many factors that go into when and how much capital you raised.

And I’m only talking about it from the issuer side, there’s also the demand side. And of course, there’s the pricing, right? Nobody likes to raise a lot of money at prices that they find unattractive. So I just want to caution you about oversimplifying or over interpreting our financial moves as indicative of signals, as to when and where and how Roche data could be available in the future.

Jack Allen : Got it. Thanks so much for that context. And I’ll jump back in the queue. I’m sure, others have questions as well.

Brian Culley : I appreciate the questions, Jack. Thank you.

Operator: The next question comes from the line of Kristen Kluska from Cantor Fitzgerald. Please go ahead.