About Cingulate^®

About Cingulate®

Cingulate^® (CTx^®) is a Phase 3 clinical stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build and advance a pipeline of branded next-generation pharmaceutical products. These will be designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic areas, such as anxiety disorders, where PTR™ technology may be employed to develop future product candidates.

CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) are engineered using an innovative, versatile platform technology that will enable the formulation and manufacturing of multi-dose tablets designed to deliver a rapid onset and last the entire active-day while providing a controlled descent of drug to optimize treatment. The Company completed a proof of concept trial in human subjects to validate the Precision Timed Release™ (PTR™) drug delivery platform for CTx-1301, submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and has now completed a Phase 1/2 comparative bioavailability study and an adult laboratory classroom study. A pediatric classroom study and the pivotal Phase 3 fixed dose pediatric and adolescent study are ongoing. The Phase 3 program for CTx-1301 is called Mastery, whereas the Phase 3 program for CTx-1302 will be designated as Accomplish™.

Cingulate completed a human formulation trial in the fourth quarter of 2021 for our third candidate, CTx-2103, to treat anxiety disorders. CTx-2103 contains one of the most widely prescribed anxiolytic agents which must be taken several times a day. CTx-2103 will be designed as a once-daily, multi-release tablet with clear differentiation and compelling advantages over standard treatment options.

Precision Timed Release Platform Technology^TM (PTR^TM)

A platform technology incorporates multiple systematic and validated processes that can be applied to the development of many drug candidates. This methodology ensures consistency and diminishes the need to reinvent a basic technology for each new product candidate, with the goal of saving time and money. Platform technology incorporates consistent equipment, analytical techniques, and operations. Analytical methods are validated and transferable allowing for transparent decision-making for each product candidate. Platform technologies support efficiency, consistency, and risk minimization.

Cingulate has developed a pharmaceutical platform designated Precision Timed Release Platform Technology^TM (PTR^TM) in which multiple releases of an active pharmaceutical ingredient (API) can be incorporated into one tablet. The API can be delivered precisely throughout the day, with either an immediate or sustained dose. The aim is to create novel extended-release drug products to serve patient needs for consistent and convenient drug delivery. Theoretically more than one API can be incorporated into a tablet, again looking to serve patient needs.

The Cingulate^®leadership team brings extensive expertise in neuroscience treatments, clinical trials, pharmaceutical development, manufacturing, commercialization, market access and patient care, and has partnerships with first-rate regulatory, legal, intellectual property, compliance, finance and investment organizations. In addition to establishing a world-class Scientific Advisory Board of key neuroscience thought leaders, Cingulate leadership has also participated in:

• 200+ clinical trials
• 300+ publications
• 30+ FDA drug approvals and the management of several billion-dollar brands

The company is headquartered in Kansas City.