Cingulate Provides 2022 Clinical Plan for CTx-1301, an Investigational Medication for Attention Deficit/Hyperactivity Disorder (ADHD) Expedited Clinical Program Reduces Capital Requirements

Provides 2022 Clinical Plan for CTx-1301, an Investigational

Medication for Attention Deficit/Hyperactivity Disorder (ADHD)

Clinical Program Reduces Capital Requirements

CITY, KS, February 8, 2022 - Cingulate Inc. (NASDAQ: CING), a clinical-stage 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 updates to its 2022 clinical program for its lead candidate CTx-1301, an investigational asset for the treatment

of Attention Deficit/Hyperactivity Disorder (ADHD).

year, the Company plans to initiate its CTx-1301 Phase 3 clinical studies: a fixed-dose pediatric and adolescent safety and efficacy

study, a dose-optimization study extension, and a pediatric safety and efficacy study to assess the onset and duration of efficacy.

Specifically, the pivotal, fixed-dose study is slated to begin in the second quarter of 2022. These studies will be conducted in the

United States (U.S.) and are instrumental for the filing of the New Drug Application to the U.S. Food and Drug Administration (FDA),

expected in the second half of 2023.

on feedback from the FDA regarding the CTx-1301 initial Pediatric Study Plan (iPSP), and longstanding guidance on the 505(b)(2) pathway,

Cingulate has accelerated its study timeline, with a strong likelihood of reducing capital requirements by condensing the number and design of studies, therefore potentially reducing its time

are determined to bring our lead candidate, CTx-1301, to market as efficiently as possible, within the FDA regulatory pathway for a 505(b)(2) drug. The expedited timeline of our clinical trials will allow us to commercialize

our products more quickly, addressing the significant unmet needs in the ADHD market, and ultimately improving patient outcomes," said

Shane J. Schaffer, Cingulate Chairman and Chief Executive Officer. "These studies allow Cingulate to compile a robust data set for our FDA filing,

providing clinicians and payers clear evidence of the potential benefits of CTx-1301."

Attention Deficit/Hyperactivity Disorder (ADHD)

Deficit/Hyperactivity Disorder (ADHD) is a chronic neurobiological and developmental disorder that affects millions of children and often

continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes

with functioning or development.

the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD.

Among this group, approximately 80 percent receive treatment, with 65 percent demonstrating clinical ADHD symptoms that persist into

adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), double the size of the child and

adolescent segment combined, however, only an estimated 20 percent receive treatment.

there is no single medical, physical, or genetic test for ADHD, qualified mental health care professionals and physicians can provide

a diagnostic evaluation after gathering information from multiple sources, including: ADHD symptom checklists, standardized behavior

rating scales, detailed histories of past and current functioning, and information obtained from family members or significant others

who know the person well. Some practitioners will also conduct tests of cognitive ability and academic achievement to rule out a possible

learning disability.

Inc. (NASDAQ: CING), is a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release (PTR )

drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, 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 where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders.

is headquartered in Kansas City. For more information visit Cingulate.com

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