Silence Therapeutics plc (NASDAQ:SLN) Q4 2023 Earnings Call Transcript

Craig Tooman: Maybe just a quick comment on partnering for PV. We are a company that likes partnering very much. Our proprietary programs are obviously exhibiting just excellent data. But we continue to look at partnerships, new and current partnerships, and are very happy with the way those are also playing out. PV is an area that Silence, ourselves could pursue, we believe, in the chassis that we have in that we can build. But to be honest, there are also companies and parties that are very interested in partnering with us as well. So as part of the portfolio, we’ll continue to look at that mix.

Kostas Biliouris: Thank you. Very helpful.

Operator: Thank you. We’ll now go to the next question. And your next question comes from the line of Patrick Trucchio from H.C. Wainwright. Please go ahead.

Patrick Trucchio: Thanks. Good morning and congrats on the data today. Just a couple of follow-up questions from me. The first is, as we look ahead to a potential Phase 3 program for zerlasiran, can you tell us how you would intend to move this program forward? Would you look to do this on your own or maybe find a collaboration partner ahead of Phase 3? And separately, do you need to wait for the 48 week data or the longer term data, or can you — or a potential partner go ahead with end of Phase 2 meeting with the FDA before then? And then separately, just on SLN501. I’m wondering why Mallinckrodt decided not to move ahead with the program, something about the data or was this a strategic decision? And more broadly, can you discuss your strategy with moving a complement program forward?

Craig Tooman: So let me start, in reverse order of, SLN501, as you know, and we announced today. Yes, Mallinckrodt did let us know that they’ll not be pursuing that. And you’ll recall that, we actually bought back the two preclinical assets last year that we believe were the best fit for Silence. We saw the preclinical data and like that very much. It’s always been a kind of a portfolio view for us. Steve, you’ve been at Mallinckrodt and are now with us, you’ve been on both sides and kind of spearheaded that compliment. Maybe you have a comment on that portfolio view.

Steven Romano: Yes. Well, only that, we, as you know, brought back two preclinical assets, the data of which are very, very good. So the bottom line is, we’ve always looked at this as a portfolio opportunity even as we brought those two new assets — those two assets back in-house. The [C3] (ph) areas, I’ll speak for ourselves at Silence. The C3 areas are complex area, it’s very competitive. We feel like the additional targets, which we’ve not disclosed may actually give us a more competitive opportunity to be competitive in that space. And we are actually evaluating as we move forward in the preclinical and nonclinical development space, considerations for clinical targets with those, which we’ll disclose over time.

Craig Tooman: In terms of the Phase 3 for zerlasiran, I want to tell you and be clear that we’re full steam ahead. We’ve been planning this protocol for over a year. This is something that we’ve tested with KOLs, with our great development team, and also some external advisors. So we feel like we’re in very, very good shape in terms of the planning for that. In terms of the funding for that, Rhonda, maybe you just want to touch on that. And then Steve, maybe you want to touch on your conviction of the protocol as well.

Steven Romano: Yes.

Rhonda Hellums: Yes, sure. Thanks, Craig. Yes, so we, of course, with the raise that we did in the beginning of this year, we are anticipating that we have the ability to continue to move that forward. As Craig mentioned earlier, we are actively looking at different partnerships. So we have been very, open about looking at partnerships for this program specifically, but also other programs as well. So we feel like we have the resources we need to continue to advance this program, so that we can keep this momentum moving.

Steven Romano: Yes, and I’ll just add as Craig suggested, just a couple of comments. We are well advanced with regards to the design of the Phase 3 protocol. And as I’ve talked to many of you about, we’ve got great input by leading experts, renowned experts in the field of lipidology as well as clinical trialists, etcetera. So we feel very confident. In fact, that’s where we really feel the opportunity could be to distinguish our compound from others that are currently advance into Phase 3. The types of patients we include, some of the specific criteria for inclusion and exclusion, the ability for that data potentially to read through to the label. So we’re thinking very, very robustly about how best to position our Phase 3 program, but that’s advancing very nicely and we will move.

I think someone had asked this as well and I didn’t reference it, but we will move into a phase — into a discussion with the agency and we’ll wait — we’ll have that 48 week data at that time point, because I think that is an important piece of information to help confirm our dosing strategy going forward, as well as the final design of the trial. So we feel very good about the progression we’ve made and the opportunity to differentiate in that way.