Lineage Cell Therapeutics, Inc. (AMEX:LCTX) Q4 2022 Earnings Call Transcript

And that means partnering with people who have high capabilities and are going to increase leadership to be financially rewarding and strategically valuable. And that means partnering with people who have high capabilities and are going to increase the probability of success. I do think from an approach that the success that we’ve had so far, and that I believe will continue with the OpRegen program does create a certain amount of a halo effect on other assets. Clearly, we are working with different cell types, and so there’s not a perfect apples to apples comparison. But conceptually, the notion that cells are capable of doing things that are beyond the reach of small molecules is a notion that we think is being borne out in the setting of dry AMD and we believe will be applicable in other settings.

And I could refer to this morning, there was a trial that was unsuccessful in the setting of spinal cord injury utilizing a particular scaffold. There were no biologics involved. It was just pure scaffold. Unfortunately for patients that was not a study that was successful. But again, to me, that is another reminder in the field that sometimes — sometimes the standard or expected approaches just aren’t quite strong enough when the condition is very severe, as in the case of cells that are dying off, it goes far beyond a single pathway and getting to the level of the entire cell or the cell has been destroyed through after an accident or, or some sort of trauma, such as the case of spinal cord injury.

Operator: Our next question comes from the line of Joe Pantginis from HC Wainwright. Please proceed.

Joe Pantginis: Hey everybody, good afternoon. Thanks for taking the question. So Brian, I wanted to focus on your two leading regulatory discussions and I’ll start with VAC2, if you don’t mind. So obviously you talked about the pre-IND discussions right now are surrounding production processes as well as characterization of the cells. So I was curious, how do those processes differ, if any, from what CRUK is doing?

Brian Culley: Thank you Joe for that question, I would say that the, the similarities in the process they, they exist, but one of the reasons that we exercise the option is that we saw an opportunity to improve upon those processes. I want to be really clear for everyone listening that each cell type that we try to manufacture demands and requires its own unique set of, of steps ,so we do not have a one size fits all differentiation secret sauce that we apply to different cell types. It, it really is a laborious effort to figure out how to get these cells to behave in the way that we want so that we’re only manufacturing the cells, which we desire to be used in the clinic. So in the setting of the dcs, which we manufacture, we’ve made great strides in improving the characterization of those cells.

And some of that data and information has been provided to FDA so that they can see what we would plan to use going forward. So there definitely are some differences relative to what we what we were making or what, excuse me, what was being used by CRUK. But at the end of the day, there are release criteria and properties that are consistent across the material. So it’s not like it’s a different cell type that would necessarily lead to large differences in clinical behavior. We really have been satisfied with the clinical performance. We’re, we’re looking more to how we can optimize it, how can we scale and get better production costs and make it more affordable and allogeneic off the shelf option for patients, and how can we increase the, the potency, perhaps lower the dose.

These are all things that we are working on to see if we can improve a product profile in what is otherwise, very much a challenging clinical setting.