Core Insights - Cingulate Inc. has announced the development of CTx-2103, a once-daily formulation of buspirone aimed at addressing anxiety disorders, which represent a significant market opportunity valued at $5.5 billion in the U.S. and $11.6 billion globally [1][4] - The company has received a $3 million grant to accelerate the development of CTx-2103, which will be disbursed in three tranches based on product development milestones [2] - CTx-2103 is expected to reduce reliance on benzodiazepines, which are associated with withdrawal and dependency issues, thus providing a safer alternative for patients [1][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][8] - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, with an initial focus on ADHD and anxiety disorders [8] Product Details - CTx-2103 is a novel multi-release tablet of buspirone that utilizes Cingulate's PTR™ technology, designed to provide controlled drug release at specific times [4][6] - Buspirone, the active ingredient, is a non-benzodiazepine anxiolytic that may have a lower side-effect profile compared to traditional anxiolytics, with no associated risk of physical dependence [4][5] Market Context - Anxiety disorders are the most prevalent mental health issues in the U.S., affecting an estimated 31% of adults at some point in their lives, highlighting a significant unmet medical need [4][5] - The COVID-19 pandemic has exacerbated anxiety-related disorders, increasing the urgency for effective treatment options [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-40874 Cingulate Inc. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule ...

Core Viewpoint - Cingulate Inc. is progressing towards the submission of a New Drug Application (NDA) for its lead ADHD treatment, CTx-1301, with a scheduled in-person meeting with the FDA on April 2, 2025, and aims for submission in mid-2025 [1][5][2]. Financial Highlights - Cingulate reported a working capital increase of $17.5 million compared to December 31, 2023, resulting in approximately $7.5 million in working capital as of December 31, 2024 [9][8]. - Cash and cash equivalents rose to approximately $12.2 million, a $12.1 million increase from the previous year, extending the cash runway into Q4 2025 [9][8]. - The net loss for the year ended December 31, 2024, was $15.5 million, a decrease from $23.5 million in 2023, reflecting reduced development activity and personnel costs [9][10]. Clinical and Business Updates - Safety data from final Phase 3 trials for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials [5][4]. - Cingulate completed its final FDA-required food effect study for CTx-1301, demonstrating that the drug can be taken with or without food [5][4]. - A European patent for CTx-1301 was issued, covering up to 30 territories, including the UK, with additional patents pending in other regions [5][4]. Market Position and Strategy - Cingulate's 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][4]. - The company is exploring licensing agreements both domestically and internationally to expand its market reach [5][4]. Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to provide a once-daily stimulant medication for ADHD, optimizing patient care with a multi-core formulation [12][13]. - The drug aims to deliver three releases of medication throughout the day, addressing the challenge of providing effective treatment for the entire active day [12][13].

In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025$17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for NDA Submission KANSAS CITY, Kan., March 26, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced ...

Financial Performance - Cingulate Inc. reported a net loss of $15.5 million for the year ended December 31, 2024, a decrease from a net loss of $23.5 million in 2023[10] - Research and development expenses were $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities[10] - Working capital increased by $17.2 million to approximately $7.5 million as of December 31, 2024, compared to a negative working capital of $9.6 million in 2023[7] - Cash and cash equivalents rose to approximately $12.2 million as of December 31, 2024, a significant increase of $12.1 million from the previous year[9] - Cingulate raised $9.4 million from a common stock offering and $8 million from a purchase agreement in 2024, strengthening its financial position[5] Product Development - Cingulate is on track for a New Drug Application (NDA) submission for CTx-1301 in mid-2025, following a scheduled pre-NDA meeting with the FDA on April 2, 2025[3] - Safety data from two Phase 3 studies for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials[3] - The company completed its final FDA-required study in January 2025, confirming that CTx-1301 can be taken with or without food[5] - Cingulate holds a European patent for CTx-1301, granted on August 14, 2024, covering up to 30 territories, including the UK[5] Strategic Initiatives - The company continues to explore licensing agreements and market expansion opportunities both domestically and internationally[5]

Core Insights - Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication aimed at treating ADHD, with no serious adverse events reported [2][3][4] - The company plans to submit a New Drug Application (NDA) to the FDA by mid-2025, marking a significant milestone in the development of CTx-1301 [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 [2][12] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD [12] Product Development - CTx-1301 is designed to be a once-daily stimulant medication that provides effective treatment for ADHD throughout the day, regardless of food intake [4][10] - The drug utilizes a multi-core formulation of dexmethylphenidate, which is part of the stimulant class of medications known for their efficacy in treating ADHD [9][10] Study Details - The food effect study involved administering a single 50mg dose of CTx-1301 to subjects in both fed and fasted states, with results expected in Q2 2025 [3][9] - Previous studies indicated that CTx-1301 could be taken with or without food, demonstrating its versatility [3] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [8] - The adult ADHD population is estimated at around 11 million, with only about 20% receiving treatment [8] Technology Platform - Cingulate's PTR technology allows for precise control of drug release, aiming to enhance patient care by providing a tailored dosing experience [11] - The platform is designed to deliver medication at specific intervals, improving upon existing therapies for ADHD and potentially other conditions [11]

KANSAS CITY, Kan., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has completed a financing transaction with an accredited investor which provided net proceeds to CING of $5 million. The transaction was structured as a non-convertible, unsecured promissory note in the principal amount of $5,480,000 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. Commission File Number: 001-40874 Cingulate Inc. (Exact name of registrant as specified in its charter) Delaware 86-3825535 (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of exchange on which registered Common Stock, par value $0.0001 per share CING The Nasdaq Stock Market LLC (Nasdaq Capital Market) Warrants, exercisable for one share of common stock CINGW The Nasdaq Stock Market LLC (Nasdaq Capital Market) FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 7, ...

Core Insights - Cingulate Inc. is focused on developing its lead Phase 3 asset CTx-1301 for ADHD treatment and exploring commercialization plans [1][3] - The company utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform to create next-generation pharmaceutical products [1][3] - Cingulate is also evaluating additional therapeutic areas for its PTR technology, including anxiety disorders [3] Company Overview - Cingulate Inc. is a clinical-stage biopharmaceutical company headquartered in Kansas City [3] - The company aims to improve treatment outcomes for patients with conditions that require burdensome daily dosing regimens [3] - Cingulate's initial focus is on Attention Deficit/Hyperactivity Disorder (ADHD) [3]