Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 40

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 40
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 BALANCE-CAH. BALANCE-CAH is designed as an operationally seamless three-part study (Phase 2/3/OLE). Part A is an open-label, semi-sequential cohort study to evaluate the safety, efficacy, and pharmacokinetics, or PK, of atumelnant treatment in pediatric participants with classic CAH. Part B is a double-blind, placebo controlled confirmatory portion of the study to evaluate the safety and efficacy of atumelnant in pediatric participants with classic CAH. Part C is a single-arm, open-label, long-term safety and efficacy study in pediatric participants that completed participation in either Part A or Part B of this study. We plan to initiate the BALANCE-CAH pediatric study in the fourth quarter of 2025.

•Announced that we expect to initiate the Phase 2/3 trial of atumelnant in ADCS in the first half of 2026.

Early-Stage Pipeline:

•Investigational New Drug, or IND, clearance for CRN09682, the first candidate from the nonpeptide drug conjugate, or NDC, platform. A “Study May Proceed” letter has been received to allow us to begin a Phase 1/2 dose escalation study of CRN09682 with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. We expect the first patient to receive CRN09682 in the dose escalation phase of a Phase 1/2 study in the fourth quarter of 2025. 

•Revealed preclinical data on CRN09682 (an SST2+ nonpeptide drug conjugate), CRN12755 (a Thyroid Stimulating Hormone Receptor, or TSHR, antagonist), and CRN10329 (an SST3 agonist) at our in-person and virtual Research and Development Day, or R&D Day, on June 26, 2025.

•The R&D Day presentation included the following updates on our preclinical development pipeline:

•CRN09682: 

•We shared data on CRN09682 previously presented at medical conferences that show the potency, selectivity and internalization of CRN09682. CRN09682 in tumor and plasma and free monomethyl auristatin E, or MMAE, in plasma are not observed after 24 hours in a mouse tumor model, while free MMAE cleaved from CRN09682 persists within the