David Clark: Yes. Yes, I mean as Jennifer said in the introduction, the — we’ll give precise guidance on the conduct phase for that study once we’ve finalized our planning. But studies of this sort of size that we’re talking about, 200 subjects, you would usually aim for about a 12-month recruitment phase. We can give that as general guidance. The real gating factor has been a slight delay in the study start for that study, primarily driven by global supply chain issues with packaging materials, as it would happen. So we have packaging materials that were substantially coming in later than we would have planned. And that’s probably the largest driver of the study start to change. And then the other piece that Jennifer alluded to in terms of study trial conduct, the precision on what our estimate would be for how long the study will conduct, the other major factor there is this new EU CTIS process that you will have heard of.
So there’s a new global EU clinical trial submission process. It’s no longer optional, it’s mandatory this year. And the expectation is that will slow down a lot of the EU’s — that process will be anything up to 3-plus months slower for starting EU countries because of this new process. So those are the 2 biggest factors.
Nat Charoensook: Got it, that’s very helpful. And maybe another one, like so you guide the full data from the open-label extension operation in second quarter ’23. So what do you plan to report? And what are your expectations on the data?
Jennifer Good: Yes, we get this question a lot. And we haven’t sorted that out yet. I think we want to see the data, sort of what does it show, what’s there. We will definitely report it at a medical meeting. It’s got a lot of interest by the dermatology community, for sure. How we handle it sort of from an IR perspective, if you will, we still need to sort out the best way to do that. So I’m going to defer that once we see the data and sort out the messaging from it. We’ll figure out the best way to do that.
Nat Charoensook: Got it. And last one, if I may. So what is your expectation on the R&D and SG&A expenses in ’23 compared to 2022?
Lisa Delfini: I think R&D expenses will increase in 2023 as we conduct all of these studies that were — that Jennifer referred to, as opposed to 2022.
Jennifer Good: And G&A, please, might as well.
Lisa Delfini: I think G&A will also increase slightly.
Operator: Our next question comes from Sean Kim with Jones Trading.
Sean Kim: So I guess one question on the Phase Ib respiratory physiology study. Can you give a little more color on what dosing levels you’re intending to try out for the trial? And also, how that might inform the potential Phase III programs and other trials in the pipeline?
Jennifer Good: Yes, David, go ahead.
David Clark: Yes. So most likely, we will go to the 162 dose that was included at the highest dose that was titrated to in the CANAL study. So that is likely to be — will titrate in a similar manner to the CANAL study. And sorry, what was the other component of your question?
Jennifer Good: And how to inform, David, that Phase III program and what doses we use.
David Clark: So these 2 studies really are critical coming together. So for Phase III, what we need to know is how broad a population of the IPF patients and their comorbidities. Co-morbidities including comorbidities such as disordered sleep breathing, such as sleep apnea. And we include — so the respiratory physiology study will really answer that question for us because, as we have explained in the introductory comments, that study will include subjects with increased severity and with these comorbidities that were not included in Phase II to allow us to make that call for Phase III.