Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

Core Insights - Cingulate Inc. has received a U.S. Patent Notice of Allowance for its lead ADHD candidate, CTx-1301, and has strengthened its patent estate with additional European patents granted [3][4] - The company closed a $12 million private investment in public equity (PIPE) financing, which will support its regulatory and commercialization efforts [9] - CTx-1301's New Drug Application (NDA) has been accepted by the FDA, with a target action date set for May 31, 2026 [7][20] Patent Developments - The U.S. Patent and Trademark Office issued a Notice of Allowance for CTx-1301, indicating that the patent claims are allowable, providing protection through May 2042 [3] - A European patent for CTx-1301 was granted, covering its tri-modal, precision-timed pulsatile release profile, also extending protection through May 2042 [4] Regulatory Updates - Cingulate submitted the NDA for CTx-1301 in July 2025, which was accepted for review by the FDA under the 505(b)(2) regulatory pathway [7][20] - The NDA is supported by Phase 3 clinical trials demonstrating significant improvements in ADHD control for both adult and pediatric patients [7] Financial Overview - As of December 31, 2025, Cingulate reported approximately $11.0 million in cash and cash equivalents, a decrease of $1.3 million from the previous year [10] - Research and development expenses for Q4 2025 were $2.0 million, down from $4.3 million in Q4 2024, while total R&D expenses for the year were $9.8 million, slightly up from $9.4 million in 2024 [11] - General and administrative expenses increased to $3.6 million for Q4 2025, compared to $1.9 million in Q4 2024, with total G&A expenses for the year reaching $10.2 million, up from $6.2 million in 2024 [12] Commercial Readiness - Cingulate is advancing its commercial readiness and has appointed Bryan Downey as Chief Commercial Officer to enhance its commercialization efforts [8] - The company is preparing for manufacturing scale-up and market access initiatives to support the potential launch of CTx-1301 [16]