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 received a PDUFA fee waiver from the FDA for its new drug application for CTx-1301, which is aimed at treating ADHD, saving the company approximately $4.3 million [1][2][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][6] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens [6][7] Product Information - CTx-1301 is Cingulate's lead candidate, utilizing the PTR platform to deliver dexmethylphenidate in a multi-core formulation designed for optimal patient care [4] - The drug aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [4] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment trends indicate a growing prevalence of adult ADHD [3] - In 2022, only 53.6% of children and teens diagnosed with ADHD were actively treating their symptoms with medication, highlighting a potential market opportunity for effective treatments [3]

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 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].

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].