Cingulate Inc., a biopharmaceutical company developing ADHD treatments using its proprietary Precision Timed Release (PTR) drug delivery platform, reported fourth quarter and full-year 2025 financial results and announced significant regulatory progress on its lead candidate, CTx-1301. On March 17, 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent covering CTx-1301, indicating approval of patent claims expected to provide protection through May 2042. Cingulate also received a European patent for CTx-1301 covering its tri-modal, precision-timed pulsatile release profile for ADHD treatment, granted December 17, 2025, extending protection through May 2042 and expected to be validated in more than 30 European territories.
The FDA accepted Cingulate’s New Drug Application (NDA) for CTx-1301 in October 2025 under the 505(b)(2) regulatory pathway and assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. The NDA was supported by multiple clinical studies, including Phase 3 trials showing improved ADHD control across multiple metrics in adult and pediatric patients ages 6 and older. Effect size measurements demonstrated rapid onset of effect and sustained efficacy throughout the patient’s active day. The FDA has requested additional information related to manufacturing and chemistry, manufacturing, and controls (CMC) elements; to date, requests do not relate to clinical safety or efficacy findings.
As of December 31, 2025, Cingulate had approximately $11.0 million in cash and cash equivalents, down $1.3 million from December 31, 2024. The company expects current cash on hand will satisfy capital needs into late fourth quarter of 2026 under its current business plan. Net loss was $6.3 million for the fourth quarter 2025 compared to $6.2 million for the same period in 2024. For the full year 2025, net loss was $22.4 million compared to $16.6 million for 2024. In February 2026, Cingulate closed a $12 million private investment financing led by Falcon Creek Capital affiliates at at-the-market pricing. The company appointed Bryan Downey as Chief Commercial Officer in November 2025, bringing extensive commercialization experience from prior roles at Sanofi, Jubilant Pharma, and Alfasigma USA.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/cingulate-inc-reports-fourth-quarter-and-full-year-2025-financial-results-and-operational-highlights