Crinetics Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update

Core Insights - Crinetics Pharmaceuticals has successfully launched PALSONIFY (paltusotine) in the U.S. for treating acromegaly, receiving positive feedback from both patients and healthcare providers [2][6] - The company reported a net loss of $130.1 million for Q3 2025, an increase from a net loss of $76.8 million in Q3 2024, while revenues were $0.1 million, primarily from a licensing agreement [12][16] - Crinetics anticipates a cash burn of $340-370 million for 2025, with sufficient cash reserves to fund operations into 2029 [12][17] Product Launch and Market Response - PALSONIFY was approved by the FDA on September 25, 2025, as a first-line treatment for adults with acromegaly who have not responded adequately to surgery [6][10] - The launch has seen over 95% of top healthcare providers targeted, with 95% of filled prescriptions coming from patients switching from previous therapies [6][10] - Approximately 50% of filled prescriptions have received reimbursement, indicating a favorable payer landscape [6] Financial Performance - Revenues for Q3 2025 were $0.1 million, compared to no revenues in Q3 2024, with all revenues derived from a licensing agreement [12][16] - Research and development expenses rose to $90.5 million in Q3 2025 from $61.9 million in Q3 2024, driven by increased personnel and clinical activities [12][16] - Selling, general, and administrative expenses also increased to $52.3 million in Q3 2025 from $25.9 million in Q3 2024, reflecting growth and the commercial launch of PALSONIFY [12][16] Upcoming Milestones - Crinetics plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in Q4 2025 [6] - The company expects to randomize the first patients in the CALM-CAH Phase 3 study for congenital adrenal hyperplasia and the BALANCE-CAH Phase 2/3 study in pediatrics in Q4 2025 [6] - The first patient is anticipated to receive CRN09682 in a Phase 1/2 study in Q4 2025, targeting neuroendocrine tumors [6] Company Overview - Crinetics Pharmaceuticals focuses on developing novel therapeutics for endocrine diseases and related tumors, with a pipeline of over 10 programs [9][10] - The company is committed to transforming treatment through innovative science and has a core expertise in targeting G-protein coupled receptors [9][10]