Crinetics Pharmaceuticals (CRNX) Piper Sandler 36th Annual Healthcare Conference summary

Discovery and pipeline updates

• IND submission for Graves' disease and thyroid eye disease (TED) program targeted for 2025, with ongoing IND-enabling work and safety validation for first-in-human studies.

• The TSH antagonist program aims to block both hyperthyroidism and eye disease by targeting the TSH receptor, offering a more specific mechanism than FcRn approaches and a once-daily oral option.

• Preclinical models show normalization of thyroid hormone levels, and healthy volunteer studies will assess pharmacodynamics, PK, and safety.

Neuroendocrine tumor (NET) and NDC program

• Non-peptide drug conjugate (NDC) program targets SST2-positive tumors, offering a non-radioactive, oral alternative to radiotherapies, with IND expected in early 2025.

• The NDC leverages a small molecule ligand for efficient tumor targeting and rapid systemic clearance, aiming for a favorable therapeutic window.

• Planned basket study design will enroll patients with various SST2-positive tumors, including NETs, NECs, and others, with dose escalation and expansion cohorts.

• Tumor growth rates vary widely, and the study will help identify optimal indications for expansion.

Adrenal NET, CAH, and Cushing's disease

• Full data from ongoing studies in CAH and Cushing's expected in early 2025, expanding from promising interim results showing normalization of hormone levels.

• Dose response data will inform registrational study design, with agency alignment needed for final endpoints.

• Pediatric program preparations underway, with formulation and juvenile toxicology work progressing for a 2025 start.