Cingulate(US:CING)2025-11-13 13:15Financial Performance - Cingulate Inc. reported a net loss of $7.3 million for Q3 2025, an increase of 77.6% compared to a net loss of $4.1 million in Q3 2024[12]. - General and administrative expenses increased by 69.7% to $3.1 million in Q3 2025, up from $1.9 million in Q3 2024, primarily due to personnel and commercial costs[11]. Research and Development - Research and development expenses rose to $2.8 million in Q3 2025, a 99.5% increase from $1.4 million in Q3 2024, driven by higher personnel, manufacturing, and regulatory costs[10]. - Positive Phase 3 trial results for CTx-1301 were presented, showing significant improvements in ADHD symptoms with once-daily dosing[5]. Cash Position and Financing - As of September 30, 2025, Cingulate had approximately $6.1 million in cash and cash equivalents, down from $12.2 million at the end of 2024[14]. - Cingulate completed a $6 million financing transaction to strengthen its balance sheet, structured as a non-convertible promissory note with a 9% interest rate[4]. - The company expects to raise approximately $7.0 million in additional capital to support commercialization efforts leading up to the May 31, 2026 PDUFA date for CTx-1301[9]. Regulatory Developments - Cingulate's NDA for CTx-1301 was accepted by the FDA, with a PDUFA target action date set for May 31, 2026[2]. - A commercial supply agreement was established with Bend Bio Sciences for the exclusive manufacturing of CTx-1301 in the U.S. through 2028, contingent on FDA approval[7]. - The company received a PDUFA fee waiver from the FDA, saving approximately $4.3 million[8].