Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity

Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved

Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025

CITY, Kan., August 13, 2024 -- 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 its financial results for the three months ended June 30, 2024, and provided a clinical and business update.

has achieved major development milestones in the second quarter of 2024 relating to our first product candidate, CTx-1301 for the treatment

of ADHD. The combination of the Food and Drug Administration (FDA) clearance for filing for marketing approval and completion of the

registration batches keeps us on the path to a targeted NDA submission in the first half of 2025. We are further encouraged by a recent

M&A transaction announced in the ADHD space as we continue to explore licensing opportunities for CTx-1301 in and outside the United

States," said Shane Schaffer, Chief Executive Officer of Cingulate.

Clearance to File for Marketing Approval of CTx-1301 and Development Update

achieved significant milestones relating to the development of CTx-1301 during the second quarter, including confirmation from the FDA

of the remaining clinical requirements for the filing a New Drug Application (NDA). Cingulate is progressing with these clinical activities

which include the completion of a Food Effect Study of the 50mg dose of the product and the data analysis of the Phase 3 adult dose optimization

study and the Phase 3 fixed dose pediatric and adolescent safety and efficacy study. Cingulate expects to be positioned to schedule a

pre-NDA meeting and move forward with the submission of the NDA which is targeted for the first half of 2025.

addition, Cingulate completed the manufacturing of its twelve registration batches for CTx-1301. Registration batches are required by

the FDA to be manufactured before submitting an NDA using the actual equipment, dosage strengths and procedures that will be used to

commercialize the drug product candidate.

Development and Payer Study

continues to explore additional licensing arrangements for CTx-1301 both inside and outside the US. As part of this process, Cingulate

commissioned a payer study based on its product candidate and lead asset CTx-1301 (dexmethylphenidate) for the treatment of ADHD. CTx-1301

currently is in development, so the payers were interviewed in a blinded manner and asked about a Cingulate's product candidate

that may or may not correspond to its final FDA-approved product label.

payers, representing over 121 million covered lives, were interviewed. The study reviewed current coverage and reimbursement status and

policies for ADHD treatments, assessed unmet needs and expectations for management of the category in the future, and tested the product

profile to explore payers' perceptions and expectations, including perceived value, differentiation, and expected pricing, reimbursement

and contracting potential. Key findings showed CTx-1301 to be a most valuable ADHD prospective treatment and is likely to gain

coverage through the contracting process.

Million of Capital Raised through a Warrant Inducement

late June 2024, Cingulate entered into an inducement offer letter agreement pursuant to which holders of certain of its existing warrants

from the February 2024 public offering, agreed to exercise their warrants at a reduced exercise price of $7.02 per share. In consideration

for the exercise of these warrants, the holders received new Series C and Series D common stock purchase warrants. Cingulate received

net proceeds of $1.6 million on the closing of this warrant inducement which occurred on July 1, 2024.

August 2, 2024, the Nasdaq Hearings Panel (the Panel) notified Cingulate that it had granted its request for an exception to demonstrate

compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the Bid Price Requirement) for continued

listing through August 23, 2024 (the Exception). The Panel granted Cingulate's request for the Exception, subject to (i) Cingulate

effecting a reverse stock split on or before August 9, 2024, at a ratio of between 1-for-3 and 1-for-15; and (ii) on or before August

23, 2024, Cingulate demonstrating compliance with the Bid Price Requirement by evidencing a closing bid price of $1.00 or more per share

for a minimum of ten (10) consecutive trading sessions, and evidencing compliance with all applicable criteria for continued listing

on Nasdaq. On August 9, 2024, Cingulate completed a one-for-twelve reverse stock split in an effort to evidence compliance with the Bid

Position: As of June 30, 2024, Cingulate had $0.4 million in cash and cash equivalents. On July 1, 2024, Cingulate received the net

proceeds of $1.6 million from the warrant inducement described above. Management believes this cash on hand will support operating and

development costs late into the third quarter of 2024. Management intends to seek opportunities to access additional capital as needed,

including non-dilutive capital in terms of potential licensing opportunities inside and outside of the US, and additional equity or debt

As of June 30, 2024, total liabilities were $1.9 million, a decrease from December 31, 2023 of $8.3 million, including the conversion

of the related party note payable in the amount of $3.3 million which occurred in the first quarter of 2024.

Equity: As of June 30, 2024, total stockholders' equity was $3.1 million, an increase of $10.0 million from the end of 2023.

Expenses: R&D expenses were $1.9 million for the three months ended June 30, 2024, a decrease of $2.6 million from the three

months ended June 30, 2023. This change was primarily the result of decreased clinical activity in the three months ended June 30, 2024,

as compared to the same period in 2023. During the second quarter of 2023, the Company incurred significant costs relating to two Phase

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

study. Enrollment in these two studies was completed in late 2023 and Cingulate is progressing with the remaining close-out and analytical

activities required for an NDA submission. Manufacturing costs also decreased as the activity in 2023 was more significant as it related

to the manufacture of clinical supply for the Phase 3 studies. In 2024, manufacturing activity included the completion of the manufacturing

of registration batches of CTx-1301. In addition, there was a decrease in personnel costs is the result of lower headcount and the cost

containment measures, which we implemented in late 2023 in order to conserve cash, which included salary reductions ranging from 5-55%

Expenses: Total G&A expenses were $1.3 million for the three months ended June 30, 2024, a decrease of $0.6 million from the

three months ended June 30, 2023. This was primarily the result of a decrease in personnel expenses and insurance. The decrease in personnel

expenses was the result of cost containment measures as described above.

Loss: Net loss was $3.2 million for the three months ended June 30, 2024, compared to $6.6 million for the same period in 2023. The

decrease in the net loss primarily related to a decrease in R&D and G&A expenses described above.

Consolidated Statements of Operations

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 April 1, 2024 and our other filings with the SEC. 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.

President, Investor & Public Relations, Cingulate