Cingulate Presents Data for Its Triple-Release Buspirone Product Candidate: CTx-2103

Data Demonstrated Ability of CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone – Setting the Stage for Future Trials Employing Cingulate’s Precision Timed Release™ (PTR™) Technology

CTx-2103 has the Potential to be the First Once-Daily Formulation of Buspirone, One of the Most Widely Prescribed Agents in $5.5B U.S. Anxiety Market

KANSAS CITY, Kan., Sept. 19, 2022 (GLOBE NEWSWIRE) -- 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 findings from its formulation study for CTx-2103, the Company’s asset for the management of anxiety-related disorders. The data was featured in a poster presentation at the 2022 Psych Congress meeting, taking place September 17-20 in New Orleans, LA.

“The readout of the data is a crucial step in our quest to bring the best-possible, once-daily formulation of buspirone to patients,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “Formulation development is the key component in how we approach building next-generation medicines aimed at changing the paradigm of oral drug delivery. These results provide critical information as we move forward to designing our clinical program for anxiety.”

In the study, the pharmacokinetics were evaluated for three multi-layered, timed-release oral tablets and one immediate release dose of buspirone. Scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation.

“Based on the dissolution profile seen in the data, the CTx-2103 30 mg tablet achieved the solubility required to deliver a triple release of buspirone hydrochloride,” said Matthew Brams, M.D., Chief Medical Officer and a Co-Founder of Cingulate. “The tablet was also able to deliver the intended doses at three time points. Based on this data, we’re confident in the ability of CTx-2103 to provide patients with the opportunity for entire-day efficacy, safety, and convenience in a once-daily anxiety medication.”

Anxiety disorders are the most common mental health concern in the U.S.¹ 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.²

CTx-2103, which contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine medication, has no evidence for the development or risk of dependency. However, due to its short half-life, buspirone is prescribed to be taken several times a day for management of anxiety, which can be challenging for patients and may lead to sub-optimal treatment outcomes. CTx-2103 will be designed as a once-daily, multi-dose tablet, which the Company believes will offer clear differentiation and compelling advantages over currently available treatment options.

About CTx-2103

CTx-2103 is a novel, trimodal, extended-release tablet of buspirone being developed to incorporate the Cingulate’s proprietary PTR™ drug delivery platform, and 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.

About Anxiety

Anxiety 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.

About Precision Timed Release™ (PTR™) Platform Technology and OralogiK™

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’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 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.

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About Cingulate^®

Cingulate Inc. (NASDAQ: CING), is a clinical-stage 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 neurological disorders, 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 .

Forward-Looking Statements

This 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.

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CING-US-114-0919

References:

¹ National Alliance on Mental Illness. Anxiety Disorders. Available online. Accessed May 2022.

² Kessler R.C. and P.S. Wang. The Descriptive Epidemiology of Commonly Occurring Mental Disorders in the United States*. Annual Review of Public Health. April 2008;29:115-129.