Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - Crinetics Pharmaceuticals is preparing for the commercial launch of paltusotine for acromegaly, with a PDUFA date set for September 25, 2025, and plans to initiate four late-stage trials in 2025 [1][9] - The company reported a strong financial position with $1.4 billion in cash, expected to support operations into 2029 [4][12] - Leadership changes have been made to strengthen the organization ahead of the product launch, including the appointment of a new Chief Financial Officer [2][3] Financial Performance - For the full year 2024, Crinetics reported a net loss of $298.4 million, compared to a net loss of $214.5 million in 2023 [6][13] - Revenues for 2024 were $1.0 million, down from $4.0 million in 2023, primarily from a licensing agreement for paltusotine [9][13] - Research and development expenses increased to $240.2 million in 2024 from $168.5 million in 2023, driven by higher personnel costs and increased clinical activities [9][13] Clinical Development and Regulatory Updates - The NDA for paltusotine was accepted by the FDA, based on positive results from the PATHFNDR trials [3][9] - The European Medicines Agency granted paltusotine Orphan Drug Designation for acromegaly, highlighting its potential impact [3] - Positive results were reported from Phase 2 studies of paltusotine in carcinoid syndrome and atumelnant in congenital adrenal hyperplasia [3][9] Upcoming Milestones - Enrollment for pivotal Phase 3 trials of paltusotine in carcinoid syndrome is expected to begin in Q2 2025 [9] - Crinetics plans to initiate four new IND filings in 2025 for development candidates identified in 2024 [9]