Unidentified Analyst: Got you. That makes sense. And I guess, can you provide any numbers on what that threshold is and then just kind of following-up on the STRIVE study too? Is this the safety database you expect to leverage then with any potential regulatory path for VRDN-003? Thanks.
Steve Mahoney: Yes. So 003, as we’ve talked about previously is a different molecular entity, so it will have its own path. So the answer to that question is no. On the first question, the threshold is – the threshold again, like I said, 212 is the max number. We’re not – we’ll see where we end up. The total number is 300, but that includes THRIVE and THRIVE-2 active patients on 10 mg/kg. So we’re not anticipating needing the entire STRIVE study. And again, most importantly, STRIVE is not expected to drive the timeline for BLA submission. It’s more the THRIVE-2.
Unidentified Analyst: Got it. Thank you.
Operator: Your next question comes from the line of Gregory Renza with RBC. Please go ahead.
Gregory Renza: Hey Steve, congrats on the progress. Thanks for taking my question. Maybe Steve, for you and perhaps Tom, just wanted to get your latest views on the competition for patients and clinical trials certainly, as your trials are heating up and appreciate all the progress you have made. There are others out there as well. Tepro with the subcutaneous. What’s the latest on driving demand? And what levers are you pulling to really accelerate the enrollment as well as the trial execution. Thanks.
Steve Mahoney: Yes. So I’ll turn this over to Tom in a second, but yes, I think if you could see that we enrolled, not only did we enroll THRIVE on time, we exceeded enrollment. We had really strong patient demand to drive that all within the month of March. I think that’s a – I think that should be a clear sign to the world that there are lots of patients out there with TED that want to access IGF-1R therapy. So that’s a really good sign for us. Don’t forget also that we had roughly half of the patients were enrolled in the U.S. I know that was a question mark for people. I think we’ve definitively answered that the U.S. is very – we’ve got the opportunity within the U.S. and then the other half in Europe, where the – as I mentioned, the epidemiology is the same. So that might be just a general answer. Tom Ciulla, do you want to talk about how competition for trials shaking out?
Tom Ciulla: Sure. Yes. Thanks for your question, Gregory. I’m out in the field a lot talking to investigators and KOLs both in the U.S. and ex-U.S., and I can tell you there’s a lot of excitement about our portfolio. As you know, our Phase 2 trial showed really promising results, and that’s driven a lot of interest, hence the over enrollment that Steve referenced. Also, I can tell you that with respect to STRIVE, we have an active control. There is no placebo, and we think that’s going to drive enrollment there. So I think overall, just lots of positivity around our TED portfolio in our trials. I really can’t comment on competitors, but what I can say is just lots of excitement and enthusiasm around our portfolio.
Gregory Renza: Great. Thanks, guys.
Operator: Your next question comes from the line of Julian Harrison with BTIG. Please go ahead.
Julian Harrison: Hi, good morning. Thank you for taking my question. I understand FcRn is kind of in the background this year, but I’m wondering if there’s maybe an IGF-1R to FcRn sequence and TED, that could be worthwhile to study in the future? Or are you mainly interested in FcRn opportunities beyond TED at this point?
Steve Mahoney: Yes, it’s the latter, Julian. Yes, we’re – we would – we do – so for TED patients, we firmly believe that IGF-1R is the key to that disease or the heart of that disease that’s where the cell signaling is taking place. You’ve got to hit that receptor in order to disrupt that. And so FcRns, the IL-6s, the other modalities are not or other mechanisms, we don’t feel are on target for moderate to severe TED patients. So for us, the IGF-1R is the key to TED. So FcRn will take that in different places, as we alluded to in the deck.
Julian Harrison: Thank you.
Operator: Your next question comes from the line of Trevor Allred with Oppenheimer. Please go ahead.
Trevor Allred: Hey guys, good morning. Thanks for taking the question. So with TEPEZZA sales trending down slightly, can you give us some perspective on why you think the new start market there appears to be somewhat stagnant and how you see this as a potential opportunity for you?
Steve Mahoney: Yes. I mean, I think it’s hard for us to comment on Amgen sales. I think they are – they did report on their call last week. They did report year-over-year growth, which is the first time they’ve done that since the announcement of the merger. So we see that as a really good sign. Amgen was also really confident on their call that they believe that the market continues to be underpenetrated, which we agree with, and they believe that it’s going to continue to grow. Growth areas – don’t forget, growth areas also include the other geographies, the introduction of subcu. And so they’ve now – they’ve filed in Japan and Europe, which is good as they’re continuing to kind of blaze that trail for us.
And don’t forget, even in the backdrop of all of this, they did close to $1.8 billion, or close to $2 billion in sales in 2023 in the backdrop of all of this as a first entrant. So again, we feel that there’s plenty of room to run in TED, not only in the U.S., but elsewhere as well. And then we think subcu, particularly our subcu, which we think is potentially going to be best-in-class, where we can have patients that can access it just by delivery at home and they can self administer at home. We think that’s a game changer for TED patients, and I think the physician community agrees with us on that. So yes, we’re not particularly worried about IGF-1R being the right place for TED patients, and I think Amgen is going to prove that as well.
Trevor Allred: Okay. Great. That’s super helpful. And I guess, could you give us some perspective on when we might expect to see initial FcRn data with it – with the IND coming in the year, maybe second half to mid-year 2025?
