Crinetics Pharmaceuticals Inc Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia Call Transcript

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

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Good morning team and congrats on really the outstanding results. Two quick questions. One, we're very much looking forward to the initiation of the Phase 3 study. To the extent you can comment on, could you maybe talk about some of the, given this incredible product profile, what are, REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 10, 2025 / 1:30PM, CRNX.OQ - Crinetics Pharmaceuticals Inc Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia Call how you're thinking about endpoints for primary and key secondary that you hope to power for to show key differentiation that we've seen already in this open-label data. And then question two is, as we think about this product, could you think about how it could be used in classic versus non-classic patients and what that ratio of patients are currently out there? That would be very helpful, and I'll jump back in the queue. Congrats on a great start of the year.

Question: Jessica Fye - JPMorgan - Analyst : Hey, there. Can you hear me now?

Question: Gavin Clark Gartner - Evercore ISI - Analyst : Hey, guys. Congrats on the data. Just first, on the liver enzyme elevation, it seems like it didn't result in a discontinuation. I just wanted to clarify that the patient finished the trial, ask if they received any treatment for this event and if it was mild or moderate.

Question: Gavin Clark Gartner - Evercore ISI - Analyst : That makes sense. And just on the female testosterone reduction shown. Is that data over a 24-hour period or in the morning window specifically? And then just quickly on the male side, what do you see in the part volume reduction? And could the adrenal volume reduction be a harbinger of benefit? Maybe just remind us Crinetics Pharmaceuticals impact on this measure? Thanks.

Question: Douglas Tsao - HC Wainwright - Analyst : (multiple speakers) Can you hear me now?

Question: Douglas Tsao - HC Wainwright - Analyst : Sorry about that. I had you on mute. Scott, I'm curious or whoever wants to answer this. Obviously, to the extent that glucocorticoid reduction plays into the pivotal study, how well do you think or confident are you based on the A4 reduction that you sort of have the dosing right and to sort of achieve differentiation in the market versus the recently approved product? Thank you. And I have a follow-up.

Question: Douglas Tsao - HC Wainwright - Analyst : Okay. Great. That's helpful. And then just, Scott, I guess, if we compare this final data to what was presented at Endo, we maybe didn't quite see as much consistency. Were you able to see if there were any sort of characteristics of some of the patients who didn't see quite as robust A4 reduction as what we've seen in that first initial cohort? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 10, 2025 / 1:30PM, CRNX.OQ - Crinetics Pharmaceuticals Inc Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia Call

Question: Douglas Tsao - HC Wainwright - Analyst : Okay. Great. And if I can, do you identify the 80 and 120-milligram doses is the ones you're going forward. Would you anticipate sort of just two arms? Or would you anticipate sort of having patients potentially sort of start at 80 milligram and titrate up to 120 milligram if their responses weren't quite as robust? Thank you.

Question: Douglas Tsao - HC Wainwright - Analyst : Okay, great and congratulations.

Question: Josh Schimmer - Cantor - Analyst : Thanks very much. Congrats on the update. Curious, as you move forward, especially as you're thinking about titrating down the steroid utilization of patients might you consider exploring higher doses of atumelnant? Is there anything that might preclude that? And if not, what might trigger the decision to do so?

Question: Josh Schimmer - Cantor - Analyst : Okay, thank you.

Question: Jessica Fye - JPMorgan - Analyst : Hey guys. Good morning. Hopefully, you can hear me now. Congrats on the continuing success with the molecule. Most of my questions have been asked, but maybe just for the avoidance of doubt, can we spend another moment on the elevation in liver enzymes you saw that I think was not associated with increased bilirubin. Just a couple of more details like was this just going above the upper limit of normal or some threshold like 3 times upper limit of normal. How long has the patient been on atumelnant and what was that other drug that they started that might have been what actually caused it? Thank you.

Question: Jessica Fye - JPMorgan - Analyst : And I think you said the enzymes came down after the patient one off drug. Did the patient ever go back on for the extension?

Question: Jessica Fye - JPMorgan - Analyst : Okay, got it. Thank you very much.

Question: Corey Jubinville - LifeSci Capital - Analyst : Thanks for taking our questions. Congrats on this really exciting data. I guess just coming back to the magnitude of response in the 80 mg group with the data on slide 12. It looks like many of these patients who did not achieve A4 normalization at week 12 in the 80 mg group also didn't have week 14 data in terms of follow-up. And many of those patients had really strong A4 improvements at week two that somewhat rebounded over time. I'm, of course, speculating, but were there any issues with noncompliance in some of these patients who experienced a lesser response? Or were there any specific characteristics that could have predicted a lesser response in that group as compared to those who responded really well as it relates to the Phase 3 either enrollment selection or dose selection?

Question: Corey Jubinville - LifeSci Capital - Analyst : Excellent. That's helpful. Thank you.

Question: Catherine Novack - Jones Trading - Analyst : Hi, good morning, everyone. Congrats on the data. Just one follow-up on the pediatric study. Really excited to see that you're moving forward in this population given the really severely negative impact of GC doses for young patients. With that in mind, do you have a timing in mind for the initiation of pediatric studies? What's gating? And then if you wouldn't mind sharing what ages do you anticipate starting dosing at? Thanks.

Question: Catherine Novack - Jones Trading - Analyst : Got it. Thanks very much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 10, 2025 / 1:30PM, CRNX.OQ - Crinetics Pharmaceuticals Inc Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia Call

Question: Ash Verna - UBS - Analyst : Hi, thanks for taking my questions here. I wanted to drill down on the A4 reduction in the 8 mg dose (inaudible). So does this 11-patient data include the 4 patients that had shown 96% and the interim. That would mean that to get to the 70% A4 reduction that you're reporting for 11 patients, the new 7 patients would have achieved roughly 40% A4 reduction. Let me know if I'm missing something here. And then if you can comment on the median A4 reduction for these 11 patients as well, that would be great. Thanks.

Question: Ash Verna - UBS - Analyst : The median A4 reduction, if you can comment on that?

Question: Ash Verna - UBS - Analyst : Thank you.