Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved

Core Viewpoint - Cingulate Inc. is preparing for a New Drug Application (NDA) submission for its lead ADHD treatment, CTx-1301, with a scheduled in-person meeting with the FDA on April 2, 2025, and aims for submission by mid-2025 [1][5][2]. Financial Highlights - Cingulate reported a $17.5 million increase in working capital compared to December 31, 2023, resulting in approximately $7.5 million in working capital as of December 31, 2024 [10][9]. - The company had approximately $12.2 million in cash and cash equivalents as of December 31, 2024, a $12.1 million increase from the previous year, extending its cash runway into Q4 2025 [10][9]. - Research and development expenses decreased to $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities [10][11]. - General and administrative expenses were $6.2 million for the year ended December 31, 2024, compared to $7.3 million in 2023, primarily due to reduced personnel costs [10][11]. Clinical and Business Updates - Cingulate released safety data from two Phase 3 studies for CTx-1301, confirming no serious treatment-emergent adverse events and a consistent safety profile across nine clinical trials [5][10]. - The company completed its final FDA-required food effect study for CTx-1301, demonstrating that the medication can be taken with or without food [5][10]. - A European patent for CTx-1301 was issued on August 14, 2024, covering up to 30 territories, including the UK, with additional patents pending in other regions [5][10]. - A managed care payor study indicated that CTx-1301 is perceived as the most valuable prospective treatment for ADHD, likely to gain coverage through contracting processes [5][10]. Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform to deliver dexmethylphenidate, designed for once-daily dosing to optimize patient care [13][14]. - The product aims to provide a rapid onset and sustained efficacy throughout the active day, addressing a significant need in ADHD treatment [13][14]. Market Context - ADHD affects over 20 million patients in the U.S., with a growing prevalence among adults, highlighting the market potential for effective treatments like CTx-1301 [12].