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

Core Insights - Cingulate Inc. is preparing for a New Drug Application (NDA) submission for its lead ADHD asset CTx-1301, targeting mid-2025, following a scheduled in-person Pre-NDA meeting with the FDA on April 2, 2025 [1][5][2] - The company reported a significant increase in working capital by $17.5 million compared to the previous year, extending its cash runway into Q4 2025, well beyond the NDA submission target date [1][9] - Safety results from final Phase 3 trials for CTx-1301 have been announced, showing no serious treatment-emergent adverse events, indicating a consistent safety profile across nine clinical trials [1][5] Financial Performance - As of December 31, 2024, Cingulate had approximately $12.2 million in cash and cash equivalents, a $12.1 million increase from the previous year, providing a strong cash runway [9] - Working capital reached approximately $7.5 million, reflecting a $17.2 million increase from December 31, 2023, indicating a strengthened balance sheet [9] - Research and development expenses decreased to $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, primarily due to completed clinical activities [9][10] Clinical and Business Updates - Cingulate completed its final FDA-required food effect study for CTx-1301, confirming that the medication can be taken with or without food [5] - A European patent for CTx-1301 was issued, covering up to 30 territories, including the UK, with additional patents pending in other regions [5] - 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] Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology, designed to deliver three releases of medication throughout the day, optimizing treatment for ADHD [12][13] - The product aims to provide a true once-daily stimulant medication that maintains efficacy throughout the entire active day, addressing a significant unmet need in ADHD treatment [12][14]