Press Release

CTx-2103 (buspirone) is the Third Candidate Using Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Platform Technology for Once-daily Dosing Via Three Precise, Pre-defined Drug Releases

KANSAS CITY, Kan., June 23, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage 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 completion of the formulation study for its third asset, CTx-2103, for the management of anxiety-related disorders. The study was conducted at BDD Pharma in the United Kingdom. Results are expected in August 2022.

CTx-2103 contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine medication, which 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.

“We are proud to reach this significant milestone for our Company and the PTR™ platform as we work diligently to provide a true once-daily medicine for those with anxiety-related disorders,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “Dosing frequency is an important component of medication adherence in patients and a key contributor to treatment success or failure. With the PTR™ technology as the foundation of our pipeline, we strive to make next-generation medicines that overcome significant unmet medical needs in billion-dollar markets.”

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

About CTx-2103 and the Formulation Study
CTx-2103 is a novel, trimodal, extended-release tablet of buspirone incorporating 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.

The first human subject study of CTx-2103 was a single-center, open-label, four-arm crossover study in 12 healthy subjects. Each participant received four different doses of buspirone at different assessment visits: one timed-release 10mg tablet releasing drug after a four-hour delay, one timed-release 10mg tablet releasing drug after an eight-hour delay, one triple-pulse 10mg tablet releasing drug at zero, four and eight hours, and one immediate release 10mg tablet of generic buspirone (the reference product, which is a commercially available formulation).

The primary objective is to evaluate the absorption of buspirone and the presence of metabolite 1-pyrimidinylpiperazine (1-PP) in blood plasma from time delayed formulations and correlate with scintigraphic time and site of release. Secondary objectives of the study will compare the pharmacokinetic performance of the time delayed buspirone products with a commercially available formulation. Additionally, the study will evaluate the absorption of buspirone and the presence of metabolite 1-PP in blood plasma from a triple-release product.

Safety evaluations demonstrated that CTx-2103 is safe and well tolerated. No serious, severe, or clinically meaningful treatment-emergent adverse events (TEAEs) occurred during this study. Most TEAEs were mild in severity and were consistent with events expected for buspirone. The evaluation of TEAEs, laboratory examinations, physical examinations, ECG recordings, and measurement of vital signs (blood pressure and pulse rate) revealed no safety concerns for buspirone.

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.

For more information visit Cingulate.com/technology.

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 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

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.

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 28, 2022. 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.

CING-US-110-0623

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.