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 Insights - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for CTx-1301, a medication aimed at providing once-daily symptom control for ADHD patients [1][2][3] - CTx-1301 is designed to address limitations of current ADHD therapies by offering fast onset and entire active-day efficacy with a single dose [2][3] - The ADHD market in the U.S. is valued at approximately $23 billion, and Cingulate aims to capture a significant share with CTx-1301 [3] 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 [1][8] - The company is headquartered in Kansas City and is transitioning from a development-stage company to a commercial organization [3][8] Product Details - CTx-1301 is an extended-release tablet formulation of dexmethylphenidate, designed to provide a smooth pharmacokinetic profile and address the need for entire active-day efficacy [2][5] - The medication utilizes a multi-core formulation to deliver three releases of the active ingredient at predefined times, optimizing patient care [5][6] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; the prevalence of adult ADHD is growing faster than that of children and adolescents [4] - In 2022, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication, indicating a substantial unmet need in the market [4] Technology Platform - The PTR™ platform technology includes an Erosion Barrier Layer (EBL) that controls drug release at precise times, allowing for true once-daily dosing [6][7] - Cingulate plans to leverage the PTR technology to develop additional product candidates in other therapeutic areas beyond ADHD [6][8]