Full Press Release Details
Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the $5.5 Billion
U.S. Anxiety Market, and the $11.6 Billion Anxiety Market Worldwide
Funding Expands Pipeline and Further Validates Cingulate's Proprietary Precision Timed Release Drug Delivery Technology
has the Potential to Reduce Use of Benzodiazepine's and Associated Withdrawal and Dependency Issues
CITY, Kan., April 9, 2025 - 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 has received a $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment
of anxiety. CTx-2103 has the potential to be the first, once-daily formulation of buspirone, one of the most widely prescribed agents
in the $5.5 billion U.S. anxiety market ($11.6 billion global).
grant will be made in three tranches of $1 million each, the first tranche to be paid on May 1st , and the two subsequent
tranches payable based on specified product development milestones. The foundation will receive a future royalty contingent on the commercialization
of CTx-2103, beginning six months after the after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum
cumulative royalty of $3.5 million.
grant was made by a private foundation whose foremost interest is combating the global rise of critical health issues such as anxiety
in a consequential way. We thank the foundation for this funding for the development of CTx-2103, which advances Cingulate's pipeline
and illustrates the applicability of our PTR platform. Today, we are one step closer to providing the first, once-daily medicine
for the millions of patients worldwide who suffer from anxiety-related disorders, the most common mental health issue in America and
around the world," said Cingulate Chairman and CEO Shane J. Schaffer.
to the National Institutes of Mental Health (NIMH), anxiety disorders are the most common mental health concern in the U.S. An estimated
31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they
are diagnosed or treated. 1
is a novel, multi-release tablet of buspirone that incorporates Cingulate's proprietary PTR drug delivery platform. CTx-2103
is being studied for the treatment of anxiety and/or anxiety-related disorders. Buspirone, an azapirone derivative and a 5-HT1A partial
agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may exhibit
a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated
risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid receptors.
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. 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.1
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.
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President, Investor & Public Relations, Cingulate