Core Insights - Cingulate Inc. has entered into a strategic commercial supply agreement with Bend Bio Sciences for the manufacturing of its lead asset CTx-1301, pending FDA approval [1][3] - CTx-1301 is a novel, extended-release formulation of dexmethylphenidate aimed at addressing limitations of current ADHD therapies, with an NDA submitted to the FDA on July 31, 2025 [2][3] - The agreement ensures Bend Bio Sciences will be the exclusive manufacturer of CTx-1301 in the U.S. through 2028, contingent on FDA approval, providing manufacturing security and operational efficiency for Cingulate [3][4] 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][9] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9] Product Details - CTx-1301 utilizes Cingulate's PTR technology to deliver dexmethylphenidate in a multi-core formulation designed for precise release at defined intervals, addressing the challenge of providing an entire active-day duration of action [6][7] - The formulation is designed to enhance patient care by delivering medication in a single tablet, improving adherence and treatment efficacy [6][8] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment options are often inadequate, highlighting the need for innovative therapies like CTx-1301 [5][6] - The prevalence of adult ADHD is growing faster than that of children and adolescents, indicating a substantial market opportunity for effective treatment solutions [5]

Core Insights - Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer as the company prepares to file a new drug application for its ADHD treatment CTx-1301 [1][3] - Patel brings over 20 years of legal and compliance experience in the pharmaceutical industry, having previously held senior roles at Ironshore Pharmaceuticals and Grifols [2][3] - Cingulate's lead candidate, CTx-1301, utilizes the proprietary Precision Timed Release™ (PTR™) platform to optimize ADHD treatment by providing multiple releases of medication throughout the day [6][7] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its PTR drug delivery platform [1][8] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [8] Product Details - CTx-1301 is designed to deliver dexmethylphenidate in a multi-core formulation, providing a rapid onset and sustained efficacy throughout the day [6] - The drug aims to address the challenge of providing effective treatment for ADHD patients, particularly adults, who often experience persistent symptoms [5][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion being adults; current treatment options are often inadequate for long-term management [5] - The prevalence of adult ADHD is increasing, indicating a growing market opportunity for effective treatment solutions [5]

Core Insights - Cingulate Inc. is on track to submit a New Drug Application (NDA) for its lead ADHD asset, CTx-1301, by mid-2025 following a productive Pre-NDA meeting with the FDA [2][3] - The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103, an anxiety treatment, which will be paid in three installments [5][6] - Cingulate reported a net loss of $3.8 million for Q1 2025, an increase from $3.0 million in Q1 2024, attributed to heightened development activities and reinstated salaries [11][10] Company Updates - Cingulate completed its Pre-NDA meeting with the FDA on April 2, 2025, discussing the NDA submission for CTx-1301, which is designed to treat ADHD [3] - The company announced positive results from a food effect study of CTx-1301, indicating it can be taken with or without food [4] - Cingulate's cash position as of March 31, 2025, was approximately $9.5 million, down from $12.2 million at the end of 2024, providing a cash runway into Q4 2025 [7][13] Financial Performance - Research and development expenses for Q1 2025 were $2.2 million, a 23% increase from $1.8 million in Q1 2024, primarily due to increased personnel and regulatory costs [10] - General and administrative expenses rose to $1.5 million in Q1 2025, a 30% increase from $1.1 million in Q1 2024, driven by higher professional fees and personnel costs [10] - Working capital decreased to approximately $4.9 million as of March 31, 2025, from $7.7 million at the end of 2024, reflecting cash usage for operations [8][9] Product Development - CTx-2103 has the potential to be the first once-daily formulation of buspirone, targeting the $5.5 billion U.S. anxiety market [6] - The grant received for CTx-2103 will fund development through mid-2026, with royalties contingent on future commercialization [5] - Cingulate's proprietary Precision Timed Release™ (PTR™) platform technology aims to enhance drug delivery for ADHD and anxiety treatments [19][20]

Core Viewpoint - Cingulate Inc. is preparing for a New Drug Application (NDA) submission for its lead ADHD treatment, CTx-1301, with a scheduled in-person meeting with the FDA on April 2, 2025, and aims for submission by mid-2025 [1][5][2]. Financial Highlights - Cingulate reported a $17.5 million increase in working capital compared to December 31, 2023, resulting in approximately $7.5 million in working capital as of December 31, 2024 [10][9]. - The company had approximately $12.2 million in cash and cash equivalents as of December 31, 2024, a $12.1 million increase from the previous year, extending its cash runway into Q4 2025 [10][9]. - Research and development expenses decreased to $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities [10][11]. - General and administrative expenses were $6.2 million for the year ended December 31, 2024, compared to $7.3 million in 2023, primarily due to reduced personnel costs [10][11]. Clinical and Business Updates - Cingulate released safety data from two Phase 3 studies for CTx-1301, confirming no serious treatment-emergent adverse events and a consistent safety profile across nine clinical trials [5][10]. - The company completed its final FDA-required food effect study for CTx-1301, demonstrating that the medication can be taken with or without food [5][10]. - A European patent for CTx-1301 was issued on August 14, 2024, covering up to 30 territories, including the UK, with additional patents pending in other regions [5][10]. - A managed care payor study indicated that CTx-1301 is perceived as the most valuable prospective treatment for ADHD, likely to gain coverage through contracting processes [5][10]. Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform to deliver dexmethylphenidate, designed for once-daily dosing to optimize patient care [13][14]. - The product aims to provide a rapid onset and sustained efficacy throughout the active day, addressing a significant need in ADHD treatment [13][14]. Market Context - ADHD affects over 20 million patients in the U.S., with a growing prevalence among adults, highlighting the market potential for effective treatments like CTx-1301 [12].