And then if we have something interesting to talk about. But I have been comfortable sharing that the intent here is to continue to expand the platform, which is being validated through the AMD program and to expand it into some other areas so that if in the not very far future, we find ourselves a very different company with a lot of options with respect to capital and partnerships, we might be able to accelerate our expansion of this platform and not — have failed to anticipate that success and be ready for it. But I think it’s premature to — I don’t want to be overstating the things that we’re doing. I would rather bring them out and roll them out later when they’re a little bit more fully packaged. And I think those will have a greater impact at that time.
Mayank Mamtani : Thanks for taking our questions, Brian.
Brian Culley : I appreciate it, Mayank. Thank you.
Operator: The next question comes from the line of Sean McCutcheon from Raymond James. Please go ahead.
Sean McCutcheon: Hi, guys. Thanks for taking the question. Just a couple for me. So first, can you give us some detail on the OPC1 device study expected target enrollment, maybe necessary waiting period for each patient, in the rank order of which subset of patients you’re aiming to enroll first across sub-acuchronic cervical thoracic? And then maybe just broadening out, trying to get a sense for time lines. How much follow-up do you think you’ll need across all patients within the device study? And what package will you need in order to get the device approved for subsequent studies? And how much of this can be accomplished in parallel or in sequence with the necessary regulatory steps for the new manufacturing protocol? Thanks.
Brian Culley : Thanks, Sean. Appreciate the questions. 6 to 10 patients in the current protocol, there is a stagger that’s built in, we can go with chronic right away, but there is a staging that reflects the Asia Impairment Scale of being both cervical and thoracic. So we’re aiming for 3 to 5 sub-acute and 3 to 5 chronic. The question as to how many patients will be enough to have the agency be comfortable with us using this device in larger studies, is unknowable because it will, of course, depend on the performance of the device. My operating assumption is that because we’re using the same size needle positioned in the same way that we will not have any particular challenges. And hopefully, we’ll have some great insights.
But there’s nothing that is entering the patient that has not been in these patients before. So I think from a success perspective, we are well positioned. The work that we aim to do toward the end of the study and the reason why it’s difficult for me to tell you when we think it will conclude, is that the next thing that we will do is introduce the new cells, which we have manufactured. We have shared some of the data around the new process and how much cleaner and more pure and reproducible. We have made the production of those cells but those cells have not yet made it into clinical testing. So the sequence of events here is a small number of patients with the device, a small number of patients, presumably a small number of patients with the new cells, as a bridging and then going into larger comparative or larger controlled studies.
So I don’t know yet because we have not asked the question, how many patients at the end of the dose study would we be doing with the new cells? Or would that be a separate protocol alongside? It depends on the regulatory interactions that we’ll be having this year. So I will be informing everyone about what I think that will look like as we get a little bit further into this year and have those meetings with FDA.
Sean McCutcheon: Thank you.
Brian Culley : Appreciate that question, Sean. Thank you.
Operator: The next question comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.
Michael Okunewitch : Hey, guys. Thanks for taking my question today.
Brian Culley : Hi, Michael.
Michael Okunewitch : I guess to kick things off, I would just like to see if you could provide a bit more color on the rationale for going into chronic, instead of just the subacute. Is this because you really just need to prove the device work? So the more exploratory data you can get, the better?
Brian Culley : I think that’s correct. The injury and the delivery of cells is not likely to be meaningfully, i.e., anatomically all that different between a subacute injury and a chronic injury. However, and I think that’s what is being reflected by the FDA’s permissiveness to allow us to go into chronic patients for the first time. But I do want to point out that there are not a small number of academics that believe that patients with chronic injuries do retain all of the biological capacity to regenerate. If it can be unlocked, and we have, as a field, been unsuccessful in not figuring out how to do that. So I think the highest and best use with respect to probability of success is in a subacute patient. That’s where we saw in the animals, and that’s where we’ve seen a signal in patients — in human patients.
So having the opportunity to go into chronic patients, as a way to accelerate the device study and along the way getting a free look, a free open label look into a chronic patient, I think, is really a nice way to get double information from a single study. And what makes it particularly exciting is that a chronic patient is going to, by definition, have reached a plateau in their recovery. So whereas you treat a subacute patient and you really don’t know their trajectory, you can make some educated guesses, but there are exceptions and that noise and variability makes it more difficult to tease out a signal. But a chronic patient, perhaps three years since their injury, who has a very level and predictable ability for performance scores. If that individual goes through a procedure, receive cells and then has a change in some of their scores that is going to stand out, as a very notable event.
