Galapagos NV (NASDAQ:GLPG) Q1 2024 Earnings Call Transcript

Operator: We’re going to take our next question. And the question comes from the line of Jason Gerberry from Bank of America.

Unidentified Analyst: This is [Chi] on for Jason. Maybe two on I&I for us. I’m curious, can you talk about your research and development efforts for CAR-T in the broader I&I landscape outside of lupus? And if the effort is still in early stage, when do you think investors can learn more about your efforts there? And my second question is on 3667. Curious if you have any thoughts of exploring that agent in additional indications? For instance, filgo previously had some interesting Phase II data in uveitis, and Roivant recently provided some Phase IIa top line data with their JAK1 TYK2 inhibitor. So curious, do you think the mechanism of 3667 makes sense? Or whether the market opportunity for uveitis makes sense for you to explore this agent in uveitis?

Paul Stoffels: Well, let me start with the TYK2 program, your second part of the question. We are currently validating and do the proof of concept into the two indications, dermatomyositis and lupus. We are strong believers that the mechanism of action with the complete inhibition of Type 1 interferon signaling and not inhibiting IL-10 signaling, we think that we have a product which has a good chance of working there in these type of diseases. And for that, so we will wait for — we’ll first deliver results on dermatomyositis and lupus before expanding into other indications. There might be a lot of other applications, but we have decided to first do the proof of concept or determine efficacy in those two indications before going further into others.

With regard to autoimmune and CAR-T, we absolutely are continuing to look at new technologies to step away from the integrated — the integration of viral vectors into the genetic material. And there, we have internal efforts ongoing as well as external collaboration, we explore, on new mechanisms to develop CAR-Ts without integrating viral vector system. So that’s ongoing, and we’ll keep you updated where — at the moment we have internal results or a BD opportunity which we pick up.

Operator: [Operator Instructions] The next question comes from Jacob Mekhael from KBC Securities.

Jacob Mekhael: I’m just curious when you refer to BD opportunities, I just would like to get a better idea of your approach here. Do you have a preference for licensing compared to M&A? Or are those equally on the table? And what are the factors that would influence your choice either way?

Thad Huston: I think both licensing and M&A acquisitions are on the table. We look to see where we can find opportunities where their immunology or oncology, clearly assets that are addressing high unmet medical need, where we really have a high bar. But then also looking even at late preclinical to early clinical proof-of-concept types of things where we think that we can add substantial value. So we look at all. We also have done some research collaborations early Stage 2 to broaden our portfolio. I think one thing to point out here today, too, is we’re sharing a bit more about the number of programs that we have in internal research. And Paul mentioned that we have 10 in oncology, another five in immunology. We want to continue to complement that and to build that out both in terms of CAR-T and small molecules.

So those are really — and we see tremendous opportunity, obviously, given our firepower and where we sit today. But we also have a fantastic team to assess these BD opportunities and help bring in the best things that fit for Galapagos.

Operator: [Operator Instructions] The next question comes from the line of Sean McCutcheon from Raymond James.

Sean McCutcheon: Maybe to build on the last question. So for the next wave of potential assets within the portfolio, Interesting to deal with BridGene, maybe using that as a backdrop for more macro commentary on the development strategy. They have targeted small molecules and covalent PROTACs. What is your view as you build out the portfolio on the state of play in targeted oncology? There’s a lot of me-too assets for validated targets, but where do you think Galapagos could fit in? And then maybe what’s your view on the degraders and the optionality that, that might bring in oncology and immunology? And is that an MOA that you’re interested in pursuing?

Paul Stoffels: Yes, we did a collaboration with BridGene focusing on precision medicine using new targets — not new, but existing targets which are validated, but at the same time, offer the opportunity to be differentiated with next-gen therapy, with next-gen molecules. And that’s where the combination of real unmet medical need, where there is no option, and we find a way to — with combining the diagnostic tools with having precision medicine, we think that we can — with the platform and with a team which we assembled, we can make differentiated medicines against a number of these targets. We are accessing the platforms like BridGene. We are — you’ve also seen that we did a strategic investment in Frontier, which has a very broad KRAS portfolio on the multiple opportunities for both our products, but also collaboration with the platform.

So that’s the approach we do, where every time, addressing a disease where there is no solution, allowing to go for good clinical efficacy leading to breakthrough designation and accelerated approval because of the high unmet medical need. So we basically better our process to being able to bring this type of medicines, as I just quoted. I hope we will — and hope, but we’ll plan definitely to have a more extensive review on our early stage portfolio in none of the coming quarters. We’ll see when we do that when we have the first results to present.

Operator: [Operator Instructions] Now we’re going to take our next question, and it comes from line of Sebastiaan van der Schoot from VLK.

Sebastiaan van der Schoot: In the past, you have mentioned that you see the CLL program as the most likely program to get fast proof of concept and get to the market. Can you provide your vision on the current progress of the program and the likelihood of a pivotal study after the update later this year? And maybe you can also put the results in context of BMS’ recent approval in CLL.

Jeevan Shetty: Thank you very much for the question. First of all, I’ll speak to the program, and then secondly to the data from Bristol-Myers Squibb. With regard to our — CLL high-risk CLL and Richter’s transformation studies. The expansion part of the study is to be initiated imminently. We’ve had very meaningful conversations with the authorities, the EMA in particular, with regard to our regulatory path forward. And we’ve got a clear path forward with regard to this. And the aforementioned IND also permits us to have the discussions with the regulators. We want to align with the regulators, the U.S. authorities, the FDA, and really work out a program of one set of globally appropriate studies. We have very clear direction in terms of what we wish to do in both the high-risk CLL and the Richter’s transformation population.