It was informed by updates to our dossier with respect to the IND and having alignment with FDA on that, I think, was a meaningful signal.
Alec Stranahan: Great. Thanks, guys. Very helpful.
Operator: Our next question comes from the line of Ellie Merle with UBS.
Unidentified Analyst: Hi. This is Sarah on for Ellie. Thanks so much for taking our questions. Just quickly on potential milestones from AbbVie, I know they’re not currently in your guidance. Can you remind us what the milestone would be for moving into pivotal studies with suprachoroidal. And then any color around the timing of other near-term milestones there that we should be thinking about?
Ken Mills: Sure, Sarah. Thanks for the question. Yes, we’ve disclosed that we have over $560 million of eligible development milestones associated with the partnership and a large proportion of those milestones are associated with the suprachoroidal programs transitioning into pivotal phase. So I think those are things that we view with this change in guidance and runway guidance are increasing likelihood for them to occur across the operational runway that we have now. And obviously, they’ve been answering questions already about specific timing or things that have been going into how that decision is made. What I can say about some of the updates that we’ve given recently like data we’ve with respect to the exciting data that we’ve seen from diabetic retinopathy and some of the thinking that has been going on within the partnership is that we really think that the data sets are starting to mature now to a point where those types of decisions can be made soon.
So we have the Hawaiian Eye data update coming also in the beginning of next year. These are things that now with a runway guidance into the second half of 2025 I think, are achievable. And again, I tried to frame this in the overview. I think these are opportunities to sort of bridge to obviously, we’re talking to hundreds of millions of dollars in milestones here that can occur that can bridge the company even further into years 2026, 2027, for instance. And those start to be years now where we’re talking about BLA filings of the subretinal program and potential if you think about acceleration for our Duchenne program, additional product launches. So we really like how the strategic update plan here and the interplay of some of these milestones are coming together to think about effectively having opportunities to capitalize ourselves with things that are currently assets of the company, all the way to a whole row of product approvals and potentially even profitability.
Unidentified Analyst: Great. Thanks.
Ken Mills: Thanks.
Operator: Our next question comes from the line of Luca Issi with RBC Capital Markets.
Lisa Walter: Good. Thanks for taking our questions. Just maybe one — this is Lisa on for Luca. Just maybe one on DMD. We know the AFFINITY trial is enrolling patients up to 11 years of age. However, from the EMBARK data, it appeared harder to discern a benefit in older children versus younger children. So just wondering what gives you confidence that 202 will show a benefit in older children, because especially when it appeared that the Western blot suggested that there was higher expression in the younger patient. Any color there would be helpful. Thanks.
Ken Mills: Yes. Thanks, Lisa. I mean look, we have an older patient enrolled already. And so I certainly acknowledge the remark about the differences that we’ve seen in microdystrophin expression, but we’re going to be able to see sort of unfold in front of us and continue to be able to update on the progress of that patient. I think the meaningful differentiator here is the C-terminal domain design of our expression consent. We just think that scientifically, from a biological plausibility perspective, amounts of microdystrophin that are expressed with the C-terminal domain are going to translate into improved function. And I think that gives RGX-202 better and as good as any other treatment but really better than any other treatment that’s bringing forward to-date to show improvement in older voice.
