Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 97

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 97
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 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 tumor for at least 240 hours. We also demonstrated that CRN09682 induced anti-tumor activity in a dose-dependent manner in different mouse tumor growth models without a decrease in body weight.

•We provided additional details regarding the trial design of BRAVESST2, our Phase 1/2 study of CRN09682 for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. In the Phase 1 dose escalation phase, we expect to enroll 3-6 patients per cohort until the minimum tolerated dose is confirmed. Data from the dose escalation will inform the recommended expansion dose for the Phase 2 dose expansion phase and confirm the tumor sub-types that will be enrolled in the expansion cohorts. 

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We expect to enroll up to 150 participants across both Phase 1 and Phase 2 of the trial.

•CRN12755: We provided preclinical data on our lead candidate, CRN12755, in the TSHR antagonist program for the treatment of Graves’ disease, including the two major manifestations Graves’ hyperthyroidism and Graves’ orbitopathy (Thyroid Eye Disease, or TED