Brian Culley: Kristen, if I could ask you to expand a little on that. My mind is thinking about when COVID first came along and people on ophthalmology clinical trials began skipping appointments for example wet AMD therapies, but is that what you have in mind or something more specific to OpRegen?
Kristen Kluska: Just like the geographic atrophy space in general, meaning that there are therapies approved now. So on one hand, patients may not be as interested in a clinical trial. But then to play devil’s advocate here, maybe those patients that were interested in getting on an approved therapy might be having second thoughts in light of the safety issues that have arrived.
Brian Culley: Thank you. My personal experience, because I’m not collecting data to one can rely on, but I sit there and I see the commercials for the approved agents just like all of us. And because of my association with GA, I also monitor some of the issues and concerns around vasculitis or other AEs. I believe what that all points to is the unavoidable relationship between the clinical benefit and the safety profile of any asset. And I think that the reason that safety has become the focus of the anti-complement field of late is attributable to the fact that there are some real questions not about the rate of AE and the risk to the patient, but whether the benefits are worth taking that risk. So to put a finer point on it, you just don’t get very much clinical benefit to justify the risks of even rare adverse events.
I think that is contrasted with the current product profile of OpRegen or the desired product profile of OpRegen insofar as we are going to great lengths to point to visual gains, not slower losses, and the improvement in retinal architecture, rather than slowing the progression of the disease. So we are talking about clinical outcomes that are wildly beyond the reach of anti-complement. And that would naturally invite a different level of tolerability on adverse events. These ultimately all feed down to individual choice. There are people who are willing to go to great lengths and take great risks, because vision is so critical to their daily living. There are others that feel quite differently. So I don’t think that there’s a unanimous perspective with respect to patient population.
But I do think that the patient population is getting increasingly educated thanks to the approval of the anti-complement therapies, because whereas in the past, they were told, I can’t do anything for you, stop smoking and eat your leafy green vegetables. Now they are becoming experts on their condition and they are understanding these tradeoffs and these risks. I think the overall competitive landscape and the commercial opportunity is very favorable for OpRegen, because I think that the clinical benefits are compelling. I think a single procedure is very compelling with respect to compliance and follow up. And I’m hopeful that ultimately, the safety profile of OpRegen will also provide a better ratio compared to what we are seeing on almost a daily basis with anti-complement.
I hope that is helpful to provide my view of that question.
Kristen Kluska: No, it is. Thanks so much. And then can you remind us or share what your latest thoughts are around the market opportunities specific for spinal cord injury? I know — you’ve done a lot of work with your peers in this space in particular to really put your heads together and think about a number of these questions. Thanks so much.
Brian Culley: Thank you for that question, Kristen. Because the company neither prices its product candidate at this point nor have we got a definitive idea as to what would be an on label patient population, it would be difficult to say what we think a peak sales, for example, of that asset would be. What we can point to are some reference information. Globally, the overall spinal cord therapy market I believe is referenced upwards of 7 billion, 8 billion, 9 billion, 10 billion. I think that Neuralink, which is the Elon Musk company, recently provided some very specific projections about what they think their pricing could be and how many patients they think they could be treating I believe in year five, I think they kind of came out somewhere around $800 million.
