Steve Mahoney: Yes, great. Thanks. Thanks, Mike. Let me take the second one first and then I’ll ask Tom Ciulla to weigh in on the baseline hearing question that you had first. So with respect to the VRDN-003 program, excuse me, we did have a positive meeting. We have not received the minutes yet. So – but we had a positive meeting and we are reiterating our guidance that we are going to start a pivotal program mid-year 20 this year. So we will provide a lot more detail once we get on the other side of minutes, but before we start the study. So more to come. But to answer your question, positive meeting, we feel good about our reiterating our guidance on starting that pivotal program. So we’re pretty excited there. With respect to the THRIVE and the baseline hearing, I’ll ask Tom Ciulla to jump in there, please.
Tom Ciulla: Thanks, Michael. So as we said in the previous answer, adverse events in the studies reported via the [indiscernible] standard methodology for reporting patient changes in their health, including hearing. And this was done in the TEPEZZA trials. As I mentioned, we’re also using audiometry for monitoring and that’s consistent with the current clinical practice and FDA guidance. We do have an exclusion criteria for hearing loss at baseline, you can see that exclusion on clinicaltrials.gov.
Michael Yee: Okay, thank you.
Operator: Your next question comes from the line of Gavin Clark-Gartner with Evercore. Please go ahead.
Gavin Clark-Gartner: Good morning and thanks for taking my questions. Just had two. First, on the Type C meeting for VRDN-003, does the FDA want to see any dose ranging work in TED patients as part of that pivotal? Or do you believe you can start dosing immediately in like a blinded pivotal portion of the trial?
Steve Mahoney: Yes. So thanks, Gavin. Like I said, give us a little bit more time. We’d like to see the minutes, but just take comfort from the fact that we are – we feel positive coming out of that meeting and that we are starting our pivotal program, which is what we’ve been – what we were guiding to previously, but we’ve now had that meeting. So we feel good about where we’re going. But give us a little bit more time and we’ll be able to break down those details for you. But that’s kind of where we are and we feel good.
Gavin Clark-Gartner: Sounds good. We’ll await more details. And are you able to provide any details on how the THRIVE baseline characteristics compared to TEPEZZA’s Phase 3?
Steve Mahoney: Yes, that’s another one, Gavin. I mean, it’s a great question. I totally appreciate it. It’s just that – we’re just not there yet. We don’t have all that information for baseline THRIVE. We just completed enrollment, and so it’s going to take us a bit to just get all that together. So more to come on that one as well.
Gavin Clark-Gartner: Makes sense. Thank you.
Operator: Your next question comes from the line of Rami Katkhuda with LifeSci Capital. Please go ahead.
Rami Katkhuda: Hey guys, congrats on all the progress and thanks for taking my questions as well. You touched on the significant ex-U.S. market opportunity in TED. I guess, are you planning to file for approval of VRDN-001 in the U.S. and Europe in parallel once all the data is in hand? And how large of an opportunity could that ultimately represent?
Steve Mahoney: Yes. I think the epidemiology in Europe is very similar, so we know that to be the case, similar to the U.S. that is. With respect to our ex-U.S. plans, again, that’s something we’ll probably talk a bit more about later. We are – as you can imagine, we are absolutely thinking about all that and the best approaches in these different geographies, even beyond Europe. So that’s all in the works. It will have more to say at a later time.
Rami Katkhuda: Got it. Sounds good. Thanks.
Operator: Your next question comes from the line of Derek Archila with Wells Fargo. Please go ahead.
Unidentified Analyst: Hey, this is Adam on for Derek. Thanks for taking our questions today. I guess just a couple questions on the timeline really. So given THRIVE is still reading out like mid-2024-ish and THRIVE-2 reading out end of year. What factors are driving a second half 2025 BLA submission in TED? Is this related to the STRIVE study then? And in that sense, is an interim cut, would that be sufficient from STRIVE for a BLA submission or does the whole STRIVE trial need to be completed to support the BLA submission?
Steve Mahoney: Great. Thanks, Adam. Appreciate that question. Yes. So what’s driving the timeline is, remember, so we talked about THRIVE-2 that’s a top line readout at the end of the year. So by definition, it’s not the completed study, right? So we have to let that – we have a follow-up period. There’s a total of the 52-week follow-up period, but only 37 weeks post the last dose. So there’s a follow-up period that is have to be taken into account and it’s primarily THRIVE-2 that’s driving the timeline. It really doesn’t. We’re not expecting STRIVE to have an impact there, that STRIVE should fit squarely within that timeline. And so we feel that that’s probably the driver and we don’t need all of STRIVE.
What you see there is that on the ct.gov, you see 212 patients that’s the maximum number that we’ll need. We can do a data cut as soon as we reach the requisite number for the safety database. And there is a – there are moving parts that go with that in terms of you can have dropout rates in your THRIVE and THRIVE-2. So we kind of over engineer or over set up the STRIVE study, but we can do a data cut when we hit that threshold. And again, all of this is really typical. You have to have safety database that accompanies your BLA submission. So it all kind of is normal blocking and tackling from our perspective, but just got to take into account that THRIVE-2 is just a top line readout. So there’s more to do after a top line readout, which drives the second half 2025 finally.
