Linda Marban: Yes. So we haven’t really disclosed the full magnitude of our statistical analysis plan. It’s still in late stage development and are required to submit that as yet. Currently, what I can tell you is that the effect size that we’re looking for is less than what we saw in HOPE-2 and we’re empowered to 90% power. So we have a really nice sort of benchmark of success and also we’re able to take advantage of the positive HOPE-3 data to power the study.
Michael Okunewitch: All right. Thank you very much for that Linda and congratulations once again.
Linda Marban: Thanks so much. Have a great day.
Operator: Next question comes from Aydin Huseynov with Ladenburg. Please go ahead.
Aydin Huseynov: Hi, Linda. Hi, AJ. Congratulations for the quarter and with the Nippon Shinyaku deal. I have several questions. So first of all, I want to ask you, how do you assess the European market? So given that Europeans are not really receptive to exon skippers, but how do you think this market is going to evolve? The DMD market is going to evolve? Yes.
Linda Marban: So obviously, EMA is taking somewhat of a different approach than FDA and DMD and other orphan diseases as well. What we are doing is positioning CAP-1002 worldwide as an anchor backbone therapy. We think that CAP-1002 will serve and great conjunct with gene therapies or any other approved therapies the mechanism of action is supportive with its anti-inflammatory pro regenerative anti fibrotic mechanism of action. And so our goal right now is to continue to work with the worldwide regulatory agencies to get them to the same point and to get our therapy around the globe as fast as possible.
Aydin Huseynov: Okay, understood. Thank you. One question I have regarding the enrollment in the HOPE-3 trial. So I think you mentioned 30% of 68 patients, which is around 2021. I think at the last quarter, it was 18 patients. So, is there any bottleneck in terms of the enrollment? And also want to ask you what you think about the guidance? I think the last time guidance was mid-2023, now I think the guidance is end of 2023 — fourth quarter 2023. So could you comment on the enrollment process in the HOPE-3 trial?
Linda Marban: Yes. So we started off relatively slowly, then we hit a really nice enrollment phase in the fall. And then as usual, and especially in pediatric trials, you see a significant slowdown around the holidays, who wants to spend their holiday vacation getting an infusion. Enrollment has picked up beautifully in the first quarter. We’re very excited with the enrollment and the infusions as they’re going now. We did guide last quarter that we were going to the end of Q3 for full enrollment and we are right on track for that for enrolling the 68 patients currently planned for infusion. And so we look forward to providing more color on that as the year goes on.
Aydin Huseynov: Okay, understood. So that’s the holidays. All right. I want to ask you a little bit about the Nippon Shinyaku deal, $12 million upfront. So could you tell us was it competitive? Did you have other contenders? And why I didn’t decide to make a deal now, but not after you hear back from HOPE-3 at the end of third and fourth quarter?
Linda Marban: Yes. So we really had a long time ago identified the fact that Nippon Shinyaku would be an ideal Japanese partner. They’re based in Japan. They’ve got an approved product for DMD in Japan and it was an extension of a relationship that was already solid and strong. So, of course, we talked to other parties, but felt that this would be the best one for us. In terms of the economics, the economics were very favorable, proportionately larger than the U.S. deal, taking advantage of the fact that the product is more advanced and has more clarity towards the path towards commercialization in the U.S. In terms of waiting, there’s really no reason to wait because we can get the party started, right? We can start thinking about getting the product into Japan and commercialize and we could also strategize better as to how to take advantage of the HOPE-3 data to promote with PMDA.
