Tim Power: Okay. Let’s go to the next one, please.
Operator: Our next question comes from Kripa Devarakonda with Truist Securities. Please go ahead.
Srikripa Devarakonda: Hey, guys. Thank you so much for taking my question and for all the color on the call. I had a question about your acquisition of RayzeBio and now that you’ve got enablement and we’re seeing, you know, it’s getting to be very competitive. Just wanted to see what the urgency and what strategy is to build-out the radiopharma pipeline? And also when — you know, when can we see more details on what the priorities are and also regarding actinium production going live. Thank you.
Chris Boerner: Well, let me start and then I’ll ask Samit and Adam to speak. Let me just at a high level though say that we continue to be incredibly excited about radiopharmaceuticals as a platform. It’s one of the fastest-growing platform in solid tumor oncology. We believe we have a best-in-class asset that we’ve acquired with Rayze. The integration of that team has gone very well. We continue to be very excited and happy with the bringing online of the facility in Indianapolis. So in terms of us getting that asset, incredible enthusiasm and the integration has gone well. But Samit maybe you and Adam can speak to details.
Samit Hirawat: Yeah. Thank you for the question. For Rayze, as Chris just mentioned, the platform is absolutely exciting and very encouraging data that we have seen emerging from the first program that is already in Phase 3 for the SSTR-directed radioligand therapy. And that Phase 3 program is right now enrolling in the GapNet indication as well as the small-cell lung cancer Phase 1 study is ongoing and we are looking to see a couple of other indications added over there, and we’re designing those trials as we speak and conduct those. So it holds a huge amount of promise because of the specificity of the directed radiation to the tumor itself. Thereafter, we’re looking forward to additional IND filing later this year and that might then be able to start our actually very specific tumor-directed indication within HCC at the back half of this year.
And then thereafter, we are looking to see an IND generation coming from this platform as we go forward. With the Indianapolis manufacturing facility now up and running, we’re looking forward to supplying the actinium part of it as well as the product towards the back half or back-end to early part of next year and that will certainly help in terms of continuing to supply and taking it forward. We are learning lessons from the front-runners and those lessons will be very helpful as we go into the commercial stages in a couple of years.
Chris Boerner: Adam, anything to add?
Adam Lenkowsky: Yeah. I’ll just add just a few things. You know, RayzeBio is an important strategic acquisition that we believe continues to diversify our oncology portfolio. It’s — as Chris mentioned, we see this as a modality that’s going to continue to grow over time. It will be a competitive space. But what we liked about RayzeBio that this is going to be an IND engine and, you know, the lead program, RYZ101, is already in Phase 3 development as you heard earlier for GapNet. But we have opportunities in small-cell lung cancer, in breast cancer, and potentially many other tumor types. So, this is tremendously complementary to our existing portfolio.
Tim Power: Let me go to our last question, if you don’t mind, Rocco.
Operator: Absolutely. Our final question comes from Akash Tewari with Jefferies. Please go ahead.
Ivy Wang: Good morning. Thanks for taking our questions. This is Ivy on for Akash. We just have two quick questions. The first one is a follow-up for KarXT. So, do you think patients on the drug will develop tardive dyskinesia? If not, how will that help position KarXT in the schizophrenia market? And then our second question is for CAR T. So, why do you think CAR T for autoimmune is more attractive than CD19 bispecific? And also would you consider approaches that don’t require lymphodepletion? Thanks.
Chris Boerner: Samit?
Samit Hirawat: Sure. Thank you. First of all, great profile for KarXT that, I think, Adam has spoken about earlier from a safety profile perspective and the data has recently been presented also at the SIRS Conference where we do not see the same toxicities that are seen with the atypical such as the tardive dyskinesia, the movement disorders as well as many of the other elements that have been spoken about, so I won’t repeat. So, that’s why we are very confident in the profile and looking forward to bring it to the patients with schizophrenia. And then, as David said earlier, with other indications as well for any psychosis, agitation, bipolar disorders and others that we are exploring. On the CAR T side, certainly an advantage for a single infusion leading to good outcomes for patients, especially starting with SLE in the refractory setting where patients have had multiple other treatments ongoing and organ dysfunction that occurs in these patients.
That is the advantage, a single infusion, if that can cause tremendous transformational outcomes for these patients. As you know, our program is quite large. So, we are also looking at multiple sclerosis as well as systemic sclerosis as well as idiopathic myositis. So, those programs, as they enroll patients, will generate the data and we are hoping to be able to present some data from SLE later this year. And certainly, future approaches might include non-lymphodepletion therapies, but we’re not ready for that right now. Thank you.
Chris Boerner: Thanks, Samit. And maybe I’ll just close by saying, first, thank you all for joining the call today. I know it is a very busy day for all of you. So, maybe, I’ll just leave you with a few things. First, we’re off to a very good start in 2024. Our performance this quarter reflects execution and actions that we’ve taken to strengthen the company’s long-term growth profile. Our business outlook remains unchanged from the beginning of the year. And, of course, we look forward to sharing our continued progress on future calls. And with that, we’ll close the call, and as always, the team is available to answer any questions you have following today’s discussion. And I hope all of you have a very good day.
Operator: Thank you. This concludes today’s conference call. We thank you all for attending today’s presentation. You may now disconnect your lines and have a wonderful day.
