Kristen Kluska : Hi, good afternoon. And apologies, my line cut off. So I’m sorry if I’m asking things that have already been asked. Maybe just for OPC1, Obviously, I understand the upcoming study will be focused on safety. But how are you thinking about setting expectations in the bar you hope to achieve in light of some of the differentiating factors and potential improvements you think you can have with this process?
Brian Culley : I appreciate that, Kristen, because I feel that the landscape is open, with respect to a definition of clinically meaningful change. There is a commonly cited television commercial in this field, where Christopher Reeve, aka Superman steps up out of a wheelchair and walks across the stage. I believe it was shown during Super Bowl. So it had a very large number of viewers. And it’s memorable and it’s powerful and emotional and fantastic and probably very unrealistic given the severity of the damage, at least where technology resides today. And I think where you find that example and that disconnect is when you speak with patients who say things like, well, if I could control my bladder function, it would change my world or if I could increase the angle between my thumb and index finger, it would permit me to hold a pen or a paint brush.
So we have found through our research, primary research with people who are affected by spinal cord injuries, that the reaction or the response to very small changes in their functional activities, could be enormously valuable to them as individuals, which tells us as the developer of new therapies that we want to use sensitive assessments. We want to use endpoints that have high sensitivity so that if those changes are driven by our therapy, we can detect them and show that convincing evidence to the regulatory bodies. So I think there’s an opportunity because there’s a tremendous amount of work by leading academics to investigate new and in some cases, even sort of AI-oriented endpoints because there’s high awareness in the space that we need to find better tools than using the end of a cue tip and poking someone in the arm, while their eyes are closed and saying, did you feel that?
Kristen Kluska : Thanks so much.
Brian Culley : Appreciate that question, Kristen. Thank you.
Operator: The next question comes from the line of Mayank Mamtani from B. Riley. Please go ahead.
Mayank Mamtani : Good afternoon. Thanks, for taking our questions. So maybe just related to a prior question, Brian, could you talk to what percentage of your spend is OpRegen related? And how might the global manufacturing supply chain has evolved with your partners since you struck the deal initially in December 2021? And does your cash runway include any milestone payment from Roche? And then I have a couple of callouts.
Jill Howe : So I can speak to the balance of the investment that we’ve put for OpRegen. And I would say it’s about two thirds– sorry, excuse me, one thirds of our investment to date is really what we focused on through this operating year, that’s helpful.
Brian Culley : And I can address global supply, I heard 2021. So if we’re going back into COVID, there were two things that we did to address that. One is we were very early to react one of our board members’ insights helped us anticipate that there would be disruptions to supply chains and they are continuing in different ways with tanker, shipments, et cetera. We also benefit by the fact that we are a multinational organization. We have more employees located in Israel, than we have in the U.S. So we are able to source materials, reagents talent from very diverse parts of the world. With respect to the ongoing war in Israel, we initially had a very brief disruption, which would not be surprising. I think we characterize that as a week or two, before work went back to normal.
So we’re thankful that our extremely valuable and appreciated and dedicated staff are not in direct harm’s way, and there have only been a very small number of individuals whose spouses or they individually have been called up for military duty. So I want to be very careful not to diminish the emotional impact, while at the same time, making it very clear that our business productivity and output has been almost entirely unaffected.
Mayank Mamtani : No, absolutely we appreciate that, and appreciate your comments on the empathy there. Just to clarify if assuming that the demand in the Roche study is for the 60 patients, pretty rapid thinking from a patient perspective, are you able to supply doses that are needed? I understand we don’t have full color on how the enrollment is going. But are you able to comment on that?
Brian Culley : Unfortunately, I’m not. I think that three of the first four questions, including a component of the ongoing trial is a notable highlight of the interest in that data. But unfortunately, I’m not able to add any additional information beyond the comments I’ve made so far today.
Mayank Mamtani : Understood. Thank you, Brian. And then on the hyperimmune, yeah, and then on the hyperimmune platform development activities, if you’re able to comment any progress in September, you and your partner, Eterna has had in the gene target identification, applicable indication. As you know, there’s a big derisking event coming up for one of your peers, which could be very helpful for you.
Brian Culley : Yes. I we do follow the small number of peers, that have hypoimmune cell therapy approaches in development. I think in light of the open questions over which kind of edits are perhaps best or effective being a fast follower may be advantageous in this situation, although that’s not the reason why we initiated at this time. We initiated a hypoimmune program because we’re interested in moving into areas beyond those handful of areas that have immune protection such as the eye and such as the spinal cord. We’re not at the point that we’re comfortable talking about specific indications. And frankly, in light of the interest, enthusiasm around the OpRegen program, I’m not sure we get much recognition. So I feel as a business, it makes much more sense for us to make some progress, advance some things through research.
