Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held

Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety

Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025

Funding to Accelerate Development of CTx-2103 (buspirone)

CITY, Kan., May 8, 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, today announced its financial results for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights

include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate development of CTx-2103.

first quarter of 2025 has been a very constructive one for Cingulate," stated Chairman and CEO Shane J. Schaffer. "We held

a productive meeting with the FDA last month and remain on target to file an NDA in the middle of the year for our lead ADHD asset CTx-1301.

The results announced from a food effect study of 50mg CTx-1301 - our largest dose - were positive and consistent with previous

fed/fast data (25mg CTx-1301). We were also pleased to receive a $3 million grant of non-dilutive funding for the development of CTx-2103

for the treatment of anxiety, advancing our pipeline and illustrating the applicability of Cingulate's PTR platform."

Completes Pre-NDA Meeting with FDA to Discuss New Drug Application (NDA) for lead ADHD Asset CTx-1301 and Remains on Track to Submit

the NDA Mid-2025 and Provides additional Clinical Updates

April 2, 2025, Cingulate completed its Pre-NDA meeting with the FDA to discuss the submission of an NDA for CTx-1301, its lead asset

for the treatment of ADHD. This important milestone keeps Cingulate on track for a mid-2025 submission of the NDA for CTx-1301.

March 2025, Cingulate released Phase 3 safety data for CTx-1301, showing that the safety profile of CTx-1301 has remained consistent

over the course of nine clinical trials.

late April 2025, Cingulate reported that the primary endpoint of the 50mg food effect study demonstrated that CTx-1301 can be taken with

Receives $3 million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)

April 2025, Cingulate received a $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment of anxiety,

to be paid in three installments of $1 million each. The first $1 million installment is expected to be received in May 2025, and will

be used to fund a formulation study of CTx-2103. The second $1 million installment is expected to be received upon completion of a formulation

study for CTx-2103 and the third $1 million installment is expected to be received upon completion of development batches required for

the IND (Investigational New Drug Application) for CTx-2103. This grant is projected to cover the costs of the development of CTx-2103

through mid-2026, the targeted timing of the IND for CTx-2103. The foundation will receive a future royalty contingent on the commercialization

of CTx-2103, beginning six months after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum cumulative

royalty of $3.5 million.

has the potential to be the first, once-daily formulation of buspirone, one of the most widely prescribed agents in the $5.5 billion

US anxiety market ($11.6 billion globally). CTx-2103 also presents an alternative to the use of benzodiazepines and associated withdrawal

and dependency issues.

Position: As of March 31, 2025, Cingulate had approximately $9.5 million in cash and cash equivalents, a $2.7 million decrease from

December 31, 2024 and cash runway into the fourth quarter of 2025, beyond its targeted submission of the NDA for CTx-1301.

Capital (current assets less current liabilities): As of March 31, 2025, Cingulate had approximately $4.9 million in working capital

as compared to $7.7 million as of December 31, 2024. This decrease in working capital was primarily due to the use of cash to support

operations, which was partially offset by capital raised during the quarter. Cingulate believes working capital is meaningful to investors

as a measure of short-term financial health.

Expenses: Research and development expenses were $2.2 million for the three months ended March 31, 2025, an increase of $0.4 million

or 23.0% from the three months ended March 31, 2024. This change was primarily the result of an increase in personnel expenses and development

costs in the three months ended March 31, 2025 as compared to the same period in 2024. The increase in personnel costs was the result

of the reinstatement of base salaries in September 2024 following salary reduction measures that were implemented in late 2023. Regulatory

costs increased in the three months ended March 31, 2025 as compared to the same period in 2024 due to preparation for the pre-NDA meeting

Expenses: G&A expenses were $1.5 million for the three months ended March 31, 2025, an increase of $0.3 million or 30.0% from

the three months ended March 31, 2024. This is primarily the result of an increase in professional fees and personnel expenses. The increase

in personnel costs is the result of reinstatement of base salaries in September 2024 as noted above.

Loss: Net loss was $3.8 million for the three months ended March 31, 2025, compared to $3.0 million for the three months ended March

31, 2024. The increase in the net loss relates to increased development activity as well as the reinstatement of base salaries in September

2024 as noted above.

Statements of Operations

Attention Deficit/Hyperactivity Disorder (ADHD)

is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition

is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the

U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the

age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported

they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that

persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and

adolescent segments combined.

lead candidate, CTx-1301, utilizes Cingulate's proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation

of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate

is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be

providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication

at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day

efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

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.

press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended,

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statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including

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and Exchange Commission (SEC), including the "Risk Factors" section of our Annual Report on Form 10-K filed with the SEC

on March 27, 2025 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