Cingulate(US:CING) Globenewswire·2025-05-08 20:30Core Insights - Cingulate Inc. is on track to submit a New Drug Application (NDA) for its lead ADHD asset, CTx-1301, by mid-2025 following a productive Pre-NDA meeting with the FDA [2][3] - The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103, an anxiety treatment, which will be paid in three installments [5][6] - Cingulate reported a net loss of $3.8 million for Q1 2025, an increase from $3.0 million in Q1 2024, attributed to heightened development activities and reinstated salaries [11][10] Company Updates - Cingulate completed its Pre-NDA meeting with the FDA on April 2, 2025, discussing the NDA submission for CTx-1301, which is designed to treat ADHD [3] - The company announced positive results from a food effect study of CTx-1301, indicating it can be taken with or without food [4] - Cingulate's cash position as of March 31, 2025, was approximately $9.5 million, down from $12.2 million at the end of 2024, providing a cash runway into Q4 2025 [7][13] Financial Performance - Research and development expenses for Q1 2025 were $2.2 million, a 23% increase from $1.8 million in Q1 2024, primarily due to increased personnel and regulatory costs [10] - General and administrative expenses rose to $1.5 million in Q1 2025, a 30% increase from $1.1 million in Q1 2024, driven by higher professional fees and personnel costs [10] - Working capital decreased to approximately $4.9 million as of March 31, 2025, from $7.7 million at the end of 2024, reflecting cash usage for operations [8][9] Product Development - CTx-2103 has the potential to be the first once-daily formulation of buspirone, targeting the $5.5 billion U.S. anxiety market [6] - The grant received for CTx-2103 will fund development through mid-2026, with royalties contingent on future commercialization [5] - Cingulate's proprietary Precision Timed Release™ (PTR™) platform technology aims to enhance drug delivery for ADHD and anxiety treatments [19][20]