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

Dana Aftab: And this is Dana. Thanks for the question on CD47. So as you mentioned, Gilead announced very recently that a Phase III trial of magrolimab or magro which targets CD47 within a Phase 3 trial and it’s logic malignancy and patients with high-risk MDS. And that trial was stopped due to futility. They didn’t make any other announcements on their other programs which — they have many to proceeding in a lot large array of indications. So we still have a strong belief in the CD47 pathway. Our most advanced agents as I mentioned on the call in the prepared remarks is XB014, which we feel is an important next-generation approach that was really designed based on known clinical profile of first-generation CD47 targeting agents like magro.

And it also includes a strong preclinical rationale for combining inhibition of PD-1/PD-L1, which as you know, a key adaptive immune checkpoint with inhibition of the CD47 SIRP alpha pathway, which is a key innate immune checkpoint. We feel this is still a compelling mechanism of action in solid tumors, and we also believe that investing carefully in agents that can target this pathway from multiple angles, is prudent, including with ADU-1805, in Sairopa, which as you’re aware, is also a next-generation approach, targeting multiple wheels of SIRP alpha, a very potently and selectively. So we’re still solid on our strategy to target this pathway.

Joseph Catanzaro: Okay. Great, thanks so much for taking my questions.

Vicki Goodman: Of course. Thank you.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open .

Jeffrey Hung: Thank you for taking my questions. Could you provide an update on the ADU-1805 Phase 1 study and when we might see initial data? And then I have a follow-up.

Michael Morrissey: Dana or Vicki?

Vicki Goodman: I’ll go it. Yes, so that is ongoing in dose-escalation. We’re working closely with the Sairopa team on that. It’s too early to discuss when we will have a data presentation.

Jeffrey Hung: Okay. And then on XB371, the payload differs from XB002, but given that they share the same key targeting, is the goal to mitigate risk for adverse events, while maintaining selectivity? And then, do you expect 371 to behave similarly to 002 in terms of levels of Intact ADC or free payload? Thanks.

Dana Aftab:

Y:

Jeffrey Hung: Great, thank you.

Vicki Goodman: Okay. Thank you, Jeff.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Alex Bouilloux: Hi, good afternoon. This is Alex on for Peter. Thanks for taking our questions. Just one, just given your cash position, your plans for BD and internal investments, do you see potential to increase your share buyback program potentially? Thank you.

Christopher Senner: Alex this is Chris. Thanks for the question. So right now, we are committed to the $550 million share repurchase program, we got authorized in March. And as we — time goes on, we’ll continue to evaluate how we allocate capital across the multiple areas of the business, including potential share repurchase, but also R&D and development and also commercialization

Operator: Thank you.

Vicki Goodman: Take the next question, operator.

Operator: Please standby for our next question. Our next question comes from the line of Stephen Willey with Stifel. Your line is open.

Stephen Willey: Yeah, good afternoon. Thanks for squeezing me in. Just going back to 303, could — can you just speak to the proportion of enrollment that was completed prior to making the protocol amendments? And I guess, will there now be any attempt to preferentially enrolled patients, just to get a better representation of either RAS status and/or liver mets? And then, I guess does the increase in sample size also contemplate a change in your underlying control arm assumption? I know the nine plus months control arm that emerge, that I believe which I think included both regorafenib one TAS-102 was a bit higher than what many folks kind of thought would be the case. Thanks.