Cingulate Advances CTx-1301 Safety Trials for ADHD Treatment

CTx-1301 Safety Results and Upcoming FDA Meeting

Results Have Been Submitted Ahead of In-Person Meeting with FDA.

CTx-1301: A New Class of Medication for ADHD Treatment.

Cingulate Inc. (NASDAQ: CING) is making significant strides in ADHD management with its lead candidate, CTx-1301. This innovative treatment utilizes the proprietary Precision Timed Release™ (PTR™) technology, designed to provide effective management for those battling Attention Deficit Hyperactivity Disorder (ADHD). Recently, Cingulate released positive Phase 3 safety data for CTx-1301, showing promising results ahead of a scheduled Pre-NDA meeting with the FDA.

The reported data includes safety results from various Phase 3 studies involving both pediatric and adolescent populations. These trials consist of a fixed dose study, a dose optimization study, and a food effect study conducted with healthy adults receiving CTx-1301's maximum dosage.

As Cingulate prepares for the face-to-face meeting with the FDA, it submitted crucial safety findings. These results pave the way for a New Drug Application (NDA), which is anticipated for submission in the upcoming summer.

“After thorough analysis, it’s encouraging to see that the safety profile of CTx-1301 has been consistent throughout our clinical trials,” remarked Shane J. Schaffer, Chairman and CEO of Cingulate. He expressed excitement about bringing forth a once-daily stimulant medication that could revolutionize ADHD management.

Key findings from the studies revealed that:

• No subjects reported any serious treatment-related adverse events.
• Overall, there were no significant trends indicating potential safety issues.
• The pharmacokinetics from the food effect study demonstrated consistent results, suggesting the flexibility of CTx-1301's administration.

Innovative ADHD Treatment Solutions

While there are several stimulant medications available for ADHD, many require booster doses throughout the day, which can complicate adherence to treatment plans. ADHD expert Dr. Ann C. Childress emphasized the significance of CTx-1301 in addressing challenges faced by patients and healthcare providers. Its once-daily dosing aims to reduce the burden of managing ADHD effectively.

About CTx-1301 Studies

The Phase 3 studies of CTx-1301 focus on providing comprehensive insights into its efficacy and safety:

Children/Adolescent Dose Optimization Study

• This study involved a randomized, double-blind, placebo-controlled design assessing various doses of CTx-1301 in children aged 6 to 12.
• Participants were thoroughly screened before the optimization phase, where they received doses tailored to their needs.
• Patients who completed the study had their optimal dose or a placebo assigned.

Children/Adolescent Fixed Dose Study

• A randomized multi-center study was conducted to evaluate the fixed doses of CTx-1301 in a pediatric population ranging from 6 to 17 years of age.
• The primary goal was to measure changes in ADHD symptoms across study visits.

Research Findings on ADHD

Attention Deficit/Hyperactivity Disorder affects millions of children globally, and its impact often extends into adulthood. In the U.S., a significant percentage of diagnosed youth do not receive adequate treatment. CTx-1301 aims to bridge this gap, providing a much-needed solution in this therapeutic area.

More About CTx-1301

Cingulate’s CTx-1301 is pivotal in the ADHD treatment landscape, combining advanced PTR technology to ensure precise medication release. This formulation is designed to enhance the therapeutic experience for patients and tackle the problem of short-acting medications that do not last throughout the day.

Future Directions and Company Vision

Cingulate’s mission revolves around improving the lives of patients with ADHD and potentially other conditions requiring precise medication dosing. Their innovative PTR platform showcases their commitment to revolutionizing treatment strategies aimed at optimizing patient outcomes.

For further inquiries or more information about Cingulate’s exciting developments, please reach out to:

**Thomas Dalton**
Vice President, Investor & Public Relations
Cingulate Inc.
tdalton@cingulate.com
(913) 942-2301

**Matt Kreps**
Darrow Associates
mkreps@darrowir.com
(214) 597-8200

Frequently Asked Questions

What is CTx-1301?

CTx-1301 is Cingulate's lead candidate for treating ADHD, utilizing Precision Timed Release technology for effective once-daily dosing.

When is the FDA meeting scheduled?

The FDA meeting is set for April 2, discussing the safety results and NDA submission for CTx-1301.

What are the key benefits of CTx-1301?

CTx-1301 aims to provide a consistent and effective treatment for ADHD throughout the entire active day without the need for booster doses.

How many phases of clinical trials have been completed for CTx-1301?

Cingulate has conducted nine clinical trials for CTx-1301, with recent data highlighting its safety profile.

How does Cingulate plan to use its PTR technology in the future?

Cingulate aims to expand its pipeline using PTR technology beyond ADHD, identifying additional therapeutic areas where precise drug delivery can be beneficial.

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