Exelixis, Inc. (NASDAQ:EXEL) Q2 2023 Earnings Call Transcript

Michael Morrissey: In the context — it’s Mike, In the context of Board deliberations, etcetera around our strategy and our tactics, Boards have been together now for a couple of months. We’ve met individually, small groups, committees, full Board, really pleased with the tenure, the tone, the collaboration, the focus on what we’re doing both strategically and tactically as a company, again, focused on building value for patients and therefore building value for shareholders. As you can tell by the content on today’s call, we are all in on pushing forward our R&D agenda to be able to really enable the full pipeline towards pivotal trials and eventually commercialization if we have traction there clinically in generating differentiating data.

And we’re real excited about our future and where we’re going. So stay tuned. Obviously, there’s a lot going on with us, and we’re very excited about that. And we think we’ve got a lot of room to maneuver relative to the strength of the balance sheet and the cabo commercial opportunity and just the depth you heard from Dana and Vicki today within R&D.

Derek Archila: Got it. Sounds great. Thanks. Congrats on the quarter.

Vicki Goodman: Yeah, thank you very much.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Joe Catanzaro with Piper Sandler. Your line is open.

Joseph Catanzaro: Hey, everybody, thanks so much for taking my questions here. Just two on the pipeline side of things. First one on XB002 dosing. So TIVDAK approved on every three-week dosing. But since done some work with the schedule that generated some interesting data outside of cervical. So wondering how much you consider the schedule with — which you move forward with 002? And then second question, just wondering if you have any updated thoughts on your efforts in the SIRPalpha -CD47 space in light of the recent magrolimab failure? Thanks.

Michael Morrissey: Thanks for the question. Vicki can handle the question for XB002 and then we’ll pivot over to Dana for discussion around some of our CD47 efforts. Vicki?

Vicki Goodman: Yeah, so in terms of XB002, the dose that we’re taking forward into expansion cohorts is 2.25 mg/kg with a lower dose of 1.7 mg/kg in the — into expansion in order again to meet the requirements of Project Optimus. We will be doing PK modeling to better understand exposure response across the board. I will note with respect to the TIVDAK dosing, we’ve looked at our PK profile carefully. And what we’re seeing there I think is very encouraging. So two kind of key points. One is, in terms of the level of free payload, which contributes to off-target toxicity, but not to the efficacy, we’re seeing substantially lower levels of free auristatin compared to TIVDAK at approved dose. And that seems to be playing out in the safety profile as well.

So in our chosen higher dose of 2.25, we have about five-fold lower level to payload relative to TIVDAK. In terms of the overall impact ADC, correspondingly, we’re seeing a higher exposure and really compared to TIVDAK at 2 mg/kg, in our case in doses that 1.5 milligram per kilogram and above, we’re seeing higher exposures of Intact ADC and at the selected dose of 2.25, it’s threefold higher than TIVDAK at the approved dose. So we’re quite confident that we have a solid dose to move forward with in terms of both of our doses and really now it’s about exploring the efficacy and safety profile, but the Intact ADC really should be driving the response while the low levels of free payload may help contribute to a differentiated safety profile.