Cingulate Successfully Manufactures Clinical Supply - Initiation of Pediatric Phase 3 Studies to Commence in July and August Announcement Confirms Cingulate on Track with Development and Regulatory Milestones

Successfully Manufactures Clinical Supply -

Initiation of Pediatric Phase 3 Studies to Commence in July and August

Confirms Cingulate on Track with Development and Regulatory Milestones

CITY, KANSAS - June 29, 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 successfully manufactured the clinical supply for upcoming pivotal Phase 3 trials of its lead candidate, CTx-1301 (dexmethylphenidate),

for the treatment of attention deficit/hyperactivity disorder (ADHD). All doses of CTx-1301 are now available for both pivotal Phase

3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24.

have effectively collaborated with our manufacturing partner, Societal CDMO, to successfully manufacture all doses required to initiate

our pivotal Phase 3 pediatric and adolescent clinical program, and we look forward to the initiation of the fixed-dose study,"

said Laurie A. Myers, PhD, Chief Operating Officer, Cingulate. "This accomplishment ensures that we remain firmly on track, adhering

to our previously announced timelines."

is a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD upon approval from the U.S.

Food and Drug Administration (FDA). Cingulate recently completed a Phase 3 adult onset and duration study of CTx-1301 with results

expected 3Q 2023. In addition, the Company plans to initiate two pivotal Phase 3 trials in pediatric and adolescent patients -

a fixed dose study and a dose-optimized onset and duration study in a laboratory classroom setting - in 3Q 2023. Assuming positive

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

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 Pediatric/Adolescent Fixed Dose Study

first pivotal Phase 3 trial of CTx-1301 (CTx-1301-005, NCT05286762) is a double-blind, randomized, placebo-controlled, multi-center,

fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with ADHD. The study will be comprised of a screening

period, a double-blind randomized phase, and a safety follow-up visit.

primary endpoint of the trial is mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline (pre-dose) at Visit 2 to ADHD-RS-5

scores at Visit 8. The secondary endpoint is mean change in Clinical Global Impression - Severity (CGI-S) scores within the same time

frame. Multiple safety and pharmacokinetic analyses will also be measured.

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 in addition to Anxiety and ADHD 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. To see Cingulate's PTR Platform click here.

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.

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