Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update Werth Family Investment Associates Provides Additional Capital Investment Phase 3 Adult Efficacy and Safety Trial of

Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Family Investment Associates Provides Additional Capital Investment

3 Adult Efficacy and Safety Trial of CTx-1301 Data Released

Phase 3 Pediatric and Adolescent Studies

CITY, Kan., August 14, 2023 (GLOBE NEWSWIRE) - Cingulate Inc. (NASDAQ: CING) (Cingulate, or the Company), 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 provided financial results for the quarter ended June 30, 2023, as well as a clinical

and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates

LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of

the CTx-1301 Phase 3 pediatric and adolescent studies.

believe the Phase 3 adult efficacy and safety trial is a significant clinical milestone and validation of what Cingulate has set out

to accomplish: create the only ADHD medication that overcomes the major unmet needs of currently available treatments with clear and

unmatched differentiation," said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate.

Raul Silva, MD, Chief Science Officer added, "We are pleased with the results from this trial and believe they will be replicated

in the ongoing Phase 3 pediatric and adolescent trials."

Family Investment Associates Provides $1 Million Investment

August 11, 2023, Cingulate entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the market

under Nasdaq rules, 1,823,155 shares of the Company's common stock, par value $0.0001 per share at a purchase price per share of

$0.5485, for aggregate gross proceeds to the Company of approximately $1.0 million.

completed a Phase 3 adult dose-optimization study (NCT05631626) in June 2023 and announced top-line results in

July 2023. Full results from the study, including safety data and patient reported outcomes from a pre- and post-trial

questionnaire, have been accepted for presentation at the US Psych Congress in September 2023.

Phase 3 CTx-1301-022 study assessed efficacy and safety along with onset and duration of CTx-1301 in an adult laboratory classroom. This

single-site, small pilot study in 21 adults (age range: 18-55 years) with ADHD was not intended to, nor did it, achieve statistical significance

on the primary efficacy endpoint. The findings did demonstrate that CTx-1301 demonstrated an average effect size of 1.79, greater than

twice the effect size of current ADHD products across the entire active-day duration. A meta-analysis conducted by Faraone and Glatt

(Clinical Psychiatry 71:6 June 2010) using 11 published studies with long-acting stimulants in adults demonstrated an average

effect size of 0.73. Furthermore, CTx-1301 was well tolerated with one subject randomized to CTx-1301 experiencing treatment

emergent adverse events (TEAEs), while three of subjects that were randomized to placebo experienced TEAEs.

addition to the Phase 3 adult dose-optimization study, Cingulate initiated its pivotal Phase 3 fixed-dose pediatric and adolescent safety

and efficacy study in July 2023 and a Phase 3 dose-optimization onset and duration study in pediatric patients in early August

2023. The pediatric and adolescent study - designated as the Mastery Study - and the pediatric onset and duration study are

now recruiting patients.

positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the

second half of 2024 under the Section 505(b)(2) pathway.

continues to evaluate additional strategies to obtain funding, which may include additional offerings of common stock, issuance of debt,

or other capital sources, including potential collaborations with other companies or other strategic transactions.

& Development (R&D) Expenses: R&D expenses were $4.5 million for the three months ended June 30, 2023, compared to $2.2

million for the same period in 2022. R&D expenses were $6.6 million for the six months ended June 30, 2023, compared to $4.9 million

for the same period in 2022. These changes are the result of increased development activity in 2023 as compared to 2022. The Company

initiated the Phase 3 adult dose-optimization study for CTx-1301 in late 2022 and completed it in June 2023. Additionally, the Company

completed manufacturing of Phase 3 clinical supply for CTx-1301 in the first half of 2023, and incurred start-up activities for two Phase

3 studies for CTx-1301: the pediatric dose optimization study and the fixed dose pediatric and adolescent safety and efficacy study.

and Administrative (G&A) Expenses: G&A expenses were $1.9 million for both the three months ended June 30, 2023 and the three

months ended June 30, 2022. G&A expenses were $3.6 million for the six months ended June 30, 2023, compared to $4.1 million for the

same period in 2022. This change was primarily the result of a decrease in insurance costs related to a decline in the annual directors'

and officers' insurance policy premium, which was renewed in December of 2022.

Loss: Net loss was $6.6 million for the three months ended June 30, 2023, compared to $4.0 million for the same period in 2022. Net

loss was $10.6 million for the six months ended June 30, 2023, compared to $9.0 million for the same period in 2022. The increases in

net loss are primarily due to the increases in development activity as described above.

Inc. is 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, 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 Attention Deficit/Hyperactivity Disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic

areas where its PTR technology may be employed to develop future product candidates, such as anxiety disorders.

is headquartered in Kansas City, KS. 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

Statements of Operations

Investor & Public Relations, Cingulate Inc.

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