Yaron Werber: Great. Thanks for taking my question. Nice job on the case last week. My question has to do, and I know you can’t comment on what you think the outcome would be, but can you maybe just comment that the judge did give some specifics on the next steps in terms of the initial briefs, response briefs, and the reply briefs, which are due February 20th. Do you maybe just kind of generically procedurally, can you help us understand the timing, the way you see it a little bit? Like, does that mean that the judge has a certain amount of time after the reply briefs to then render a decision or give a timeline about which he will render a decision, or just so we understand procedurally how you understand things to be?
Mike Morrissey: Yes, Yaron, thanks for the question. It’s really hard for me to opine upon the nuances and details there. I would refer you back to the transcript to see exactly what he asked for and what he’s looking for. To me it seems like pretty standard stuff with how this stuff normally works, but I wouldn’t want to get into the weeds there in the details, it’s just, A, I’m not an expert, and B, it’s just, I’d want to keep it, with what’s in the public domain, what’s in the transcript, and not really opine for this.
Operator: Our next question comes from the line of Akash Tiwari from Jeffries.
Unidentified Analyst : Hi, this is Amy on for Akash. Thanks so much for taking our questions. So just two quick ones on Zanza. Number one, when will we get longer term durability data on Zanza that we can compare versus Cabo? Will be able to get a sense of this from the upcoming STELLAR-001 data? And then number two, given that both mono and combo efficacy data for Zanza looks generally in line with Cabo, we’d love to kind of revisit your internal goals here for Zanza given it’s sort of half-life, is it to replace Cabo and show a better safety and efficacy profile, or to expand into new indications? Thanks so much.
Mike Morrissey: Amy?
Amy Peterson: Yes, sure. Thanks for the question, Amy. I like your name. So, as for the longer durability, I think you’ll be able to appreciate why it is that we’re excited about the Zanza when the, after the IKCS presentation on November 10th, and if you’re not able to see that, then certainly at R&D Day, where I’ll go into some more detail. With regard to the OO1 and OO2 cohorts, many of those cohorts are enrolled and the data is maturing. There’s a number of different indications that we are assessing for support to our expanded program, our expanded development program, not only to give support to what we’re currently doing and to support, for example, contribution of components as we proceed with regulatory discussions should all those trials be positive, but also support to expand the development of Zanza into new and different indications.
And that’s where we’ll also leverage Cabo. So I can’t go into much more detail, but I will be able to probably give you some good examples of why we’re pretty bullish on Zanza at this point in time, given what we know about it relative to Cabo. And with regard to replacing Cabo, I’ll defer that back to Mike or PJ.
Mike Morrissey: Yes, I think you covered it pretty well. Again, just as you said previously, the goal here is to use Zanza to expand the indications, the combinations, the line of therapy, if you will. And Cabo sensitive types of tumors and indications, the goal is to make that opportunity for Zanza as big as possible across the different dimensions that we’re talking about here. So, it’s a very important aspiration that we have, because if we think we can help a lot more cancer patients who need better therapies across the different lines of therapy, early, late, different combination partners, et cetera.
Operator: Our next question comes from the line of Silvan Tuerkcan from JMP Securities.
Silvan Tuerkcan: Yes, thank you. Thanks for taking my question. Congrats on the quarter and Amy, congrats on the new job. I have a quick question in the press release. It seems like you released that COSMIC-313, so the triplet had a second OS look, which did not meet the threshold for stats, statistical significance. And can you just comment on when the next OS look is and what we can extrapolate from the fact that the second OS look did not meet the threshold. What are the prospects here and what are the plans as in the OS look with respect to filing and engaging with the FDA about these two populations that have different outcomes here in this trial. Thank you so much.
Mike Morrissey: Amy?
Amy Peterson: Thank Silvan. Thanks Mike and thanks Silvan. So we did press release that there was interim that was conducted in the third quarter. Data did not meet the threshold for statistical significance. And so the trial will continue to the next planned analysis, which is anticipated in 2024. Just remind everybody that these are events based and I’m not really able to provide further precision on that at this point in time. And so I don’t really have much more to say around that.
Operator: Our next question comes from the line of Peter Lawson from Barclays.
Peter Lawson: Great. Thanks for taking the question. Mike, you mentioned no new data at the R&D Day. Would you include kind of preclinical data around the new pipeline products? And then would you include timelines around data releases for ‘24 for the pipeline?
Mike Morrissey: Thanks, Peter, for the question and for digging into the details for the December meeting. Yes, I was speaking to no new clinical data. You’ll certainly see, I think, a lot of preclinical data that Dana will present and use to frame the opportunities for all the upcoming IND candidates and DC candidates that we’ve got that’s relatively broad and deep and we have a lot to share there. Timelines, again, we’ll see how that frame out. Again, both we are committed to presenting clinical data as it matures that is in the eye of the beholder in terms of how that works from a duration and durability point of view. So, stay tuned on that. And again, we have a very, I think deep presentation that we’re pulling together right now that covers all the aspects of strategically how we view success and how we’re going to go about reaching these very aspirational goals for helping improve standard of care for patients with cancer and then a lot of details and really getting in the weeds on a variety of different molecules that we’re really excited about.
So, looking forward to seeing you there.
Operator: Our next question comes from the line of Jeff Hung from Morgan Stanley.
Jeff Hung: Thanks for taking my question. Can you talk about what differentiates XL495 from other PKMYT1 inhibitors in development and what gives you confidence that it can be best-in-class, the greater selectivity, potency, lower risk of drug-drug interactions or something else? I appreciate any color you can provide. Thanks.
Dana Aftab: Sure. Thanks. Thanks for the question, Jeff. It’s Dana. So as I mentioned, XL495, we believe to be best-in-class. We don’t say that lightly. We have a lot of data to back that up. All I really want to say right now is to stay tuned for R&D Day, which is where we will be presenting a lot more data on this compound. But we did look at the competition and pursued a very solid rationale toward developing something that was best-in-class, not just a second follow-on compound.
Operator: Our next question comes from the line of Etzer Darout from BMO Capital Markets.
