Full Press Release Details
to Host CNS Key Opinion Leader Panel in New York City
Analysis of Cingulate, it's Phase 3 ADHD Adult Data, Anxiety, and PTR Drug Delivery Platform Innovations
CITY, Kan., October 17, 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, announced today that it will be hosting a key opinion leader event on the morning of October 23, 2023, at the Union
League Club in New York City.
live-streamed event will be held from 10:00am-11:30am EST at the Union League Club in Midtown Manhattan, and will focus on the
Company's leading, late-stage asset CTx-1301(dexmethylphenidate), along with ADHD and anxiety-related disorders. For those in the
New York area who would like to attend, there will be space for approximately 25-30 guests in the club's Grant Room. Those who
wish to watch the event virtually may do so through the link provided here, with the passcode 429018.
Key Opinion Leader Panel
League Club (Grant Room)
East 37th Street, New York, NY 10016
October 23, 2023, 10am-11:30am EST
The Union League Club requests that in-person attendees abide by club dress guidelines. For more information, please visit the club's
event may be added to calendars through the following links:
Chief Medical Officer, Matthew Brams, M.D., and Chief Science Officer, Raul Silva, M.D., will moderate the discussion.
panel will include Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator of Cingulate's
recently completed Phase 3 adult dose-optimization study, as well as Greg Mattingly, M.D., Founding Partner, St. Charles Psychiatric
Cingulate team thanks Dr. Childress and Dr. Mattingly for their participation in this event. We believe this will be an excellent opportunity
for healthcare providers, patients, advocacy groups, and the investor community to hear the Cingulate story and take a deeper look at
our most recent Phase 3 data with two of the top key opinion leaders in ADHD and CNS disorders," said Cingulate Chairman &
CEO Shane J. Schaffer.
Attention Deficit/Hyperactivity Disorder (ADHD)
is a chronic neurobiological and developmental disorder that affects millions of children 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.
disorders are the most common mental health concern in the U.S.1 Anxiety is the feeling of fear that occurs when faced
with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted
with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent
of U.S. adults experience an anxiety disorder at some time in their lives.2 People may live with anxiety for years before
they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related
disorders and as a result is a priority within the class of unmet medical needs in mental health.
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.
While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be
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. Cingulate 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.
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. These 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
President, Investor & Public Relations, Cingulate
Health Public Relations