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]

Core Viewpoint - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for its lead asset CTx-1301, an innovative ADHD treatment, with an anticipated FDA decision in Q4 2025 and a potential PDUFA date in mid-2026 [1][2][4]. Recent Highlights - The NDA submission for CTx-1301, a novel extended-release tablet formulation of dexmethylphenidate, aims to address limitations of current ADHD therapies by providing fast onset and entire active-day efficacy [2][4]. - Cingulate entered into a purchase agreement with Lincoln Park Capital to purchase up to $25 million of common stock over a 36-month term, allowing the company to manage its capital needs effectively [3][4]. Financial Results - As of June 30, 2025, Cingulate reported approximately $8.9 million in cash and cash equivalents, a decrease of $3.3 million from December 31, 2024, and expects to need an additional $1.5 million to support commercialization efforts for CTx-1301 [5]. - Research and development expenses increased by 43.6% to $2.7 million for the three months ended June 30, 2025, primarily due to costs associated with the NDA submission [6]. - General and administrative expenses rose by 47.1% to $1.9 million for the same period, mainly due to higher legal and financial advisory fees [7]. - The net loss for the three months ended June 30, 2025, was $4.8 million, compared to $3.2 million for the same period in 2024, reflecting increased R&D costs [7]. Product and Technology Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to deliver dexmethylphenidate in a way that optimizes patient care with a single tablet providing multiple releases throughout the day [15][17]. - The PTR technology incorporates an Erosion Barrier Layer (EBL) that controls drug release at precise times, aiming to improve treatment outcomes for ADHD and potentially other therapeutic areas [17][18]. Market Context - ADHD affects millions, with over 20 million diagnosed in the U.S., including 12 million adults and over 8 million children under 17, indicating a significant market opportunity for effective treatments [14].

Core Viewpoint - Cingulate Inc. is progressing towards submitting a New Drug Application (NDA) for its lead asset CTx-1301, a treatment for ADHD, following positive feedback from the FDA during a pre-NDA meeting [2][3]. Group 1: Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [2][9]. - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9]. Group 2: Product Details - CTx-1301 is designed to provide a once-daily stimulant medication for ADHD, utilizing a multi-core formulation of dexmethylphenidate, which is known for its efficacy and safety [5]. - The drug delivery system aims to optimize patient care by delivering three doses of medication at specific times throughout the day, addressing the challenge of maintaining efficacy over an entire active day [5][6]. Group 3: Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; however, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication in 2022 [4]. - The prevalence of adult ADHD is increasing at a faster rate than that of children and adolescents, indicating a growing market opportunity for effective treatments [4]. Group 4: Regulatory Insights - The FDA's pre-NDA meeting minutes indicate that Cingulate has adequate nonclinical safety data to support its filing and that the proposed approach to integrated safety and efficacy summaries appears reasonable [7]. - The agency has agreed to a post-NDA approval commitment for additional stability data for various dosage strengths of CTx-1301, with an expected shelf-life of 24 months at launch [7].