Cingulate Inc.

Cingulate Inc., trading under the ticker symbol CING on the Nasdaq Capital Market, is a biopharmaceutical company focused on developing next-generation pharmaceutical products utilizing its proprietary Precision Timed Release drug delivery platform technology. The company's website is located at www.cingulate.com.

The company operates as a clinical-stage biopharmaceutical enterprise with a pipeline of investigational drug candidates designed to address frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. Cingulate's primary focus is on attention deficit/hyperactivity disorder and anxiety disorders, with plans to expand into additional therapeutic areas including insomnia, pain management, Alzheimer's disease, and other neuropsychiatric conditions.

The company's lead candidate, CTx-1301, is a trimodal extended-release tablet containing dexmethylphenidate designed to provide once-daily dosing for ADHD treatment across pediatric, adolescent, and adult populations. CTx-1301 incorporates the company's proprietary Erosion Barrier Layer technology to enable precise drug release at specific time intervals, targeting a fast onset of action within thirty minutes and sustained efficacy throughout the active day. An NDA for CTx-1301 was submitted to the FDA in July 2025 with a PDUFA target action date of May 31, 2026. The company's second ADHD candidate, CTx-1302, contains dextroamphetamine and employs the same trimodal release technology. Additionally, Cingulate is developing CTx-2103, a once-daily buspirone formulation for anxiety treatment.

The company's PTR platform represents its core competitive advantage, enabling the development of single-tablet formulations that replace multiple daily doses with controlled, timed-release mechanisms. This technology addresses significant unmet medical needs by potentially reducing medication abuse and diversion, eliminating the need for afternoon booster doses, and improving patient compliance. Cingulate has established manufacturing partnerships with CoreRx Inc. and commercialization agreements with Indegene Inc. and IQVIA Inc. to support potential product launches. The company operates as a smaller reporting company and emerging growth company under SEC definitions.