Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Cingulate Inc. has made significant progress with the acceptance of its New Drug Application (NDA) for CTx-1301 by the FDA, with a target action date set for May 31, 2026 [2][20] - The company appointed Bryan Downey as Chief Commercial Officer, bringing over 25 years of experience in the pharmaceutical industry [3][6] - A $6 million financing transaction was completed to strengthen the company's balance sheet ahead of potential commercialization [3][4] Recent Highlights - The FDA accepted the NDA for CTx-1301, a once-daily extended-release therapy for ADHD, confirming the submission is complete and ready for review [2][20] - Positive Phase 3 trial results for CTx-1301 were presented at the AACAP Annual Meeting, showing significant improvements in ADHD symptoms [5][6] Financial Overview - As of September 30, 2025, Cingulate reported approximately $6.1 million in cash and cash equivalents, a decrease from $12.2 million at the end of 2024 [10][15] - The company incurred a net loss of $7.3 million for the third quarter of 2025, compared to a loss of $4.1 million in the same period of 2024, primarily due to increased R&D and G&A expenses [13][11] Operational Developments - A commercial supply agreement was established with Bend Bio Sciences for the manufacturing of CTx-1301, ensuring exclusive supply through 2028 if FDA approved [7] - Cingulate received a PDUFA fee waiver from the FDA, saving approximately $4.3 million [8][9] Research and Development - R&D expenses for the third quarter of 2025 were $2.8 million, a 99.5% increase from the previous year, driven by higher personnel and manufacturing costs [11] - General and administrative expenses rose to $3.1 million, a 69.7% increase from the same quarter in 2024, largely due to personnel costs related to the NDA submission [12]