Crinetics Pharmaceuticals Inc Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yasmeen Rahimi - Piper Sandler & Co. - Analyst : Two quick questions. The first question is, could you talk about the powering of your very innovative primary endpoint, which is a co-primary? And then short question for Cohort 4. Have you been able to collect any data from that cohort yet? And I'll jump back in the queue. Thank you again.

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : Hey guys, good afternoon. Is the CALM-CAH study design fully signed off on by FDA as a trial that could support registration? And what indication statement would you hope to secure assuming the trial is successful? Do you think you need 1 or 2 trials to get approved for CAH? Thank you.

Question: Gavin Clark-Gartner - Evercore ISI Institutional Equities - Analyst : Hey guys, thanks for taking the questions. First, just on the primary endpoint for the Phase III, what's the rationale to test the endpoint at a single point in time at 32 weeks as opposed to averaging across multiple time points? Is there any risk that A4 variability may lead to some non-responders who maybe shouldn't be non-responders?

Question: Cory Chobenville - LifeSci Capital - Analyst : So you folks have recently received acceptance for your marketing application for paltusotine in Europe. Curious how you're thinking about launch strategy in these different geographies. You previously discussed patient concentration in the U.S. is largely at these pituitary centers of excellence. Is patient concentration similar to those in Europe and or Latin America? And what, if any, are some of the material differences in the way that acromegaly patients might be treated in those geographies that might be important to consider for a launch?

Question: Alexander Thompson - Stifel, Nicolaus & Company, Incorporated - Analyst : Great, thanks for taking our question. Another on the CAH Phase III. Just wondering if you could talk a little bit about your design here in the context of glucocorticoid reduction and investigator discretion. Are there any overall guidelines for how to do this? Or how confident are you that you're not going to see a significant amount of variability here in the study?

Question: Maxwell Skor - Morgan Stanley - Analyst : I was just wondering, I recognize you're not interacting directly with CDER for paltusotine. But I was wondering if you'd comment on the evolving regulatory environment overall and how you're thinking about any potential implications for the rare disease space? Thank you.

Question: David Lebowitz - Citigroup Inc. - Analyst : Thank you very much for taking my question. The new primary endpoint seems to be a higher bar. And I am curious, do you reserve the ability to maintain also the same primary endpoint as crinecerfont to potentially use if needed for FDA approval?

Question: Brian Skorney - Robert W. Baird & Co. Incorporated - Analyst : Just also on the CAH study. In terms of enrollment criteria, how do you kind of compare exclusion/inclusion criteria to the CATALYST study? Are there differences in criteria and GC dose A4, 17-OHP to consider? And the pediatric plan you have built as a Phase II/III, is this just nomenclature? Or is there a dose-finding portion to the ped study that proceeds full Phase III enrollment?

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Welcome to Toby to the Crinetics call. [We hope to hear from you, not on a recent ad call]. But maybe just as a follow-up on CAH and the pediatric study. I'm just curious how you think about that program moving forward. Do you anticipate sort of -- Dana, you referred to sort of need to do some dose exploration. Would you anticipate needing potentially to do 2 studies there? Or do you think there's an opportunity to do an adaptive design, which would enable you to only run one study? And again, would you anticipate -- you just said that you anticipate sort of having the same goals as with the CALM-CAH study. Does that imply that you would think about the same endpoint in terms of normalization A4 and physiologic GC? Or is there some other potential sort of similar endpoint, but perhaps a slightly different one for targeted for the pediatric population? Thank you.

Question: Andy Chen - Wolfe Research - Analyst : Hey, thank you for taking the question. And back to your Phase III trial design. So I understand that the speed of reduction is individualized, but is it mandatory reduction at each stage of GC reduction? Or is it optional reduction for patients? If it's optional, does that make the primary endpoint very wonky and highly dependent on baseline characteristics of patients? Is that a worry here or no? Thank you.

Question: Catherine Novack - JonesTrading Institutional Services - Analyst : Hi, afternoon, everyone. Just wanted to ask one question about paltusotine. So based on PATHFNDR-2, we know you can go into treatment-naive patients, but do you anticipate any possible step-through requirements for payers based on price? How are you thinking about that?