Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients

Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD

Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023

Phase 3 Trials in Pediatric/Adolescent Patients on Schedule for 3Q 2023 Initiation

CITY, KANSAS - June 8, 2023 - 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 it has completed its Phase 3 adult dose-optimization trial of its lead candidate, CTx-1301 (dexmethylphenidate),

a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder

(ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

Phase 3 CTx-1301-022 study (NCT05631626) assessed the onset and duration of CTx-1301 in 21 adults (age range: 18-55 years)

with ADHD in an adult laboratory classroom setting. Results from the trial are expected in 3Q 2023 and will be submitted for presentation

at a future medical meeting.

available stimulant medications have failed to address the large and growing unmet need for true once-daily dosing in ADHD treatment,

and onset and duration are two of the most important efficacy parameters that Cingulate plans to improve upon to achieve this,"

said Raul R. Silva, M.D., Chief Science Officer, Cingulate. "If the Phase 3 CTx-1301-022 study results are positive, these data

will add to the growing body of evidence from earlier trials showing that CTx-1301 has the potential to offer patients best-in-class

onset and duration."

United States Centers for Disease Control (CDC) has cited a 10 percent increase in stimulant medicine prescriptions in the adult ADHD

population. Of the multitude of ADHD medications available, no methylphenidate medication offers a single oral dose that provides patients

entire active-day efficacy.

medications are the most effective tools we have to address ADHD symptoms in patients, but their short half-life require that more than

60 percent of patients be prescribed booster doses - a primary source of non-compliance and misuse of this class of medicines,"

said Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator in the Phase 3 CTx-1301-022

formulation of dexmethylphenidate is designed to cover a patient's entire active day and, if the Phase 3 trials are successful,

would give physicians the ability to avoid the booster dose, and ultimately provide patients a single administration to improve outcomes."

Dr. Childress continued, "The American Professional Society of ADHD and Related Disorders (APSARD) announced plans to develop and

publish guidelines for the diagnosis and treatment of ADHD in adults. As there are currently no guidelines in the United States, the

APSARD guidelines will address this critical need for health care providers, patients, and the public." Dr. Childress is the President

of APSARD through 2023.

addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent

study and its pivotal dose-optimization onset and duration trial in pediatric patients in 3Q 2023. Assuming positive clinical results

from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2)

Attention 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. In 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 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood.

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

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

the CTx-1301 Phase 3 Adult Dose-Optimization Study

first Phase 3 study (CTx-1301-022, NCT05631626) for CTx-1301 is a single-center, dose-optimized, double-blind, randomized,

placebo-controlled, parallel efficacy and safety adult laboratory classroom (ALC) study with CTx-1301 in 21 adults (age range: 18-55

years) with ADHD. The study was comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a seven-day

safety follow-up period. Subjects underwent a screening visit prior to entering a five-week dose-optimization phase.

the dose-optimization phase, subjects had weekly visits and were titrated to doses ranging between 25 mg and 50 mg of CTx-1301. Cingulate

utilized an ALC, which enabled it to facilitate repeated assessments over the course of a day to evaluate the onset and duration of efficacy

provided by CTx-1301. Eligible subjects were randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice visit

with four Permanent Product Measure of Performance (PERMP) assessments. Subjects took their assigned/randomized dose over the following

seven-day period. On the seventh day, subjects completed a full ALC visit. The duration of the full ALC visit was approximately 17 hours.

Subjects had an in-clinic safety follow-up visit within seven days after the full ALC visit.

primary objective of CTx-1301-022 was to evaluate the efficacy of CTx-1301 compared to placebo in treating adults with ADHD in an ALC

study. Secondary objectives included determination of the onset and duration of clinical effect of CTx-1301 in treating ADHD in adults

in an ALC study and to determine safety and tolerability of CTx-1301 compared to placebo. The study also evaluated the quality and satisfaction

of prior medication to CTx-1301. The Phase 3 clinical trial program for CTx-1301 is being conducted in the U.S. and is instrumental for

the filing of the NDA to the FDA, expected in mid-2024.

lead candidate, CTx-1301, utilizes Cingulate's proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation

of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate

is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients

entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time,

ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with

the third dose being released around the time when other extended-release stimulant products begin to wear off.

Precision Timed Release (PTR ) Platform Technology

is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate's innovative

PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at

precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing

core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the

core tablet. The EBL formulation, Oralogik , is licensed from BDD Pharma.

intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product

candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at

specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. For more

information visit Cingulate.com/technology.

Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary 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 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. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended,

and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than

statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including

statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical

studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities

and other statements that are predictive in nature.

statements are generally identified by the use of such words as "may," "could," "should," "would,"

"believe," "anticipate," "forecast," "estimate," "expect," "intend,"

"plan," "continue," "outlook," "will," "potential" and similar statements

of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is

not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements

as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the "Risk

Factors" section of our Annual Report on Form 10-K filed with the SEC on March 10, 2023. All forward-looking statements speak only

as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result

of new information, future events or otherwise, except to the extent required by law.