Company: CRNX
Filing Date: 2025-04-23
Form Type: DEF 14A
Source: 0000950170-25-057452
Chunk: 44

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-04-23
Form: DEF 14A
Chunk 44
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 have significant efficacy, safety and/or tolerability limitations. Our lead product candidate is paltusotine, which is in clinical development for the treatment of acromegaly and carcinoid syndrome associated with neuroendocrine tumors, or NETs. Our second product candidate is atumelnant (formerly CRN04894), which is in clinical development for congenital adrenal hyperplasia, or CAH, and patients with either Cushing's disease or Ectopic ACTH Syndrome, or EAS. We are advancing additional product candidates through preclinical discovery and development studies. Our vision is to build a premier, endocrine-focused, global biopharmaceutical company that consistently pioneers new therapeutics that improve the lives of patients. Business Highlights In the year ended December 31, 2024, our executive team focused the company’s efforts on the most critical business objectives and we achieved several key successes: • In March 2024, we reported positive topline results from the PATHFNDR-2 study, where the study met statistical significance on the primary endpoint and all secondary endpoints. In September 2024, we submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for paltusotine for the proposed treatment and long-term maintenance therapy of acromegaly, and in December 2024, we received notification of acceptance from the FDA on the status of the NDA

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submission and were granted a Prescription Drug User Fee Act, or PDUFA, Target Action Date of September 25, 2025. • We have initiated the CAREFNDR Phase 3 clinical trial in patients with carcinoid syndrome. CAREFNDR is designed as a double-blind, placebo-controlled, sixteen-week clinical trial to enroll carcinoid syndrome patients who are not on pharmacological treatment and are actively symptomatic. The primary endpoint of the CAREFNDR trial is the percentage change in the frequency of flushing episodes at week 12 as compared to the baseline measurement. In addition, a key secondary endpoint measures the change in bowel movement frequency at week 12 as compared to the baseline measurement. The CAREFNDR trial is designed to capture other efficacy endpoints including severity of flushing and urgency of bowel movements. • In February 2025, the EMA granted paltusotine orphan drug designation for the treatment of acromegaly. Designation was given following a positive recommendation from the EMA Committee for Orphan Medicinal Products, highlighting the potential