Karen Sims: Sure, absolutely. So, as we said throughout this process, we certainly do intend to re-engage the FDA for this program. And really, the criteria for that is — are when we feel that we have sufficient data, to return to them with a robust package to be able to move forward in the U.S. So, that line of communication is certainly always open, and we’re looking forward to the AB-101 trial continuing to proceed as it is and accumulating that data to be able to share back with the FDA. And this development strategy is something we’ve done before. We’ve frequently taken assets initially outside of the United States for a Phase 1 study and then brought them back to FDA to initiate Phase 2 trials along with other global jurisdictions as we need to increase study populations and study size.
And then in regard to how the study is progressing and output, as we said just now, we have progressed the study into multiple dosing in healthy subjects. We do intend to share preliminary data from healthy subjects in the first half of this year. The study is designed as an umbrella study, so a seamless transition into chronic hepatitis B patients once we have sufficient data to move forward into that population and certainly, we’ll be sharing updates as they become available with the study in an ongoing fashion.
Roy Buchanan: Okay, great. And then if I could ask one about VTP-300. What do you need to see from the results this half to kind of move that approach forward and potentially, I guess, make it a cornerstone? But you mentioned combos with imdusiran and 101. Yes, what do you need to see to add VTP-300 or another vaccine to that approach? Or do you really need to see the nivo data? Thanks.
Michael McElhaugh: Yes, it’s a good question, Roy. So, honestly, I think we just need to see what the data look like and we’ll continue to evaluate as it comes forward. As you rightfully mentioned, we added the nivo arm to that study as well. I think we’d probably want to see that nivo data before moving that combo forward, unless, of course, we see something spectacular out of the VTP-300 plus imdusiran arm and I have no insight into that. Currently, I just — it will depend on what the data look like. Obviously, with VTP-300 not being a proprietary asset, we’re considering thinking about imdusiran plus 101 and moving that forward as quickly as we can. That’s always been sort of the goal. But the data will guide us, I think is probably the best way to think about it.
Roy Buchanan: Yes, thanks.
Michael McElhaugh: Sure.
Operator: All right. Next question comes from the line of Ed Arce of H.C. Wainwright. Your line is now open.
Thomas Yip: Hi, good morning everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. First question for the new 203 Phase 2a study with durvalumab, can you discuss the design in broad strokes how big will the study be? And any specific elements that we can expect the study that is learning from the ongoing 202 study?
Michael McElhaugh: Yes. Karen, do you want to handle that one, please?
Karen Sims: Yes, sure. So, again, we typically don’t dive into the details of our study designs until we’re able to announce the first subject, first dose in the study. So I can’t elaborate much beyond what we’ve already said. Again, the goal of the study is to try to help inform upcoming studies with imdusiran in combination with AB-101, so looking at different options in terms of the timing of adding a PD-L1 inhibitor to imdusiran therapy is really the high-level goal. In terms of the size of the study, it is a typical 2a size study. This is again an exploratory study to try to basically learn about, again, that optimal timing, optimal duration of that combination approach. So, the study is listed on clinicaltrials.gov, and you’re certainly welcome to peruse that for any additional details there. But again, we will share more specific details about the trial once we add and have subjects enrolled.
Thomas Yip: Got it. Understood. And then, same thing, similar along with that line, just thinking ahead of the combination study with imdusiran and then with 101. Will the first study be a similar proof-of-concept study, Phase 2a that we’ve seen with other combinations as well?
Karen Sims: Yes, I can jump into that one as well. Typically, it is. I mean the rationale really for starting with a Phase 2a study is, certainly for AB-101, we will still be increasing the safety database for that. The molecule will be — still learning additional information about PK and pharmacodynamics and a larger population of subjects. So, moving to a Phase 2a study is fairly routine with an early development asset just to make sure we’re fully understanding the different aspects of the molecule before taking it into a larger Phase 2b type study. And that really is just all about derisking the compounds and making sure that we’re completely comfortable taking it into these larger studies, which, as you know, are very technically difficult, very expensive.
So, it’s — most likely, it will start with a smaller 2a study. But again, as Mike mentioned throughout the call, we need to see the data and see how the data guides us. So, more to come on that as the AB-101 program moves through Phase 1.
Thomas Yip: Got it. Understood. And then one final question from us. Just trying to narrow down the timing of the first half readouts, most notably the 201 end-of-treatment data readout and then also the AB-101 [indiscernible] data. Are these separate events? Or should we expect kind of like a big splash at EASL?
