Form 8-K

8-K — Cingulate Inc.

Accession: 0001493152-26-028815

Filed: 2026-06-16

Period: 2026-06-16

CIK: 0001862150

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): June 16, 2026

CINGULATE

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-40874

86-3825535

(State

or other jurisdiction

(Commission

(IRS

Employer

incorporation)

File

Number)

Identification

No.)

1901

W. 47th Place

Kansas

City, KS 66205

(Address

of principal executive offices) (Zip Code)

(913)

942-2300

(Registrant’s

telephone number, including area code)

(Former

name or former address, if changed since last report.)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions (see General Instruction A.2. below):

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of exchange on which registered

Common

Stock, par value $0.0001 per share

CING

The

Nasdaq Stock Market LLC

(Nasdaq

Capital Market)

Warrants,

exercisable for common stock

CINGW

The

Nasdaq Stock Market LLC

(Nasdaq

Capital Market)

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)

or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging

growth company ☒

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

7.01. Regulation FD Disclosure.

June 16, 2026, Cingulate Inc. (the “Company”) issued a press release announcing that the United States Patent and

Trademark Office (“USPTO”) issued the Company U.S. Patent No. 12,653,791 (the “Patent”) covering

key aspects of CTx-1301’s formulation and method of use through December 2042. The Company previously announced the USPTO’s

issuance of a Notice of Allowance for the Patent. A copy of the press release announcing the issuance

of the Patent is attached hereto as Exhibit 99.1.

The

information included in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K is not deemed to be “filed” for

purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall this Item

7.01 and Exhibit 99.1 be incorporated by reference into the Company’s filings under the Securities Act of 1933, as amended, or

the Exchange Act, except as expressly set forth by specific reference in such future filing.

Item 9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press Release, dated June 16, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

CINGULATE

INC.

Dated:

June 16, 2026

By:

/s/

Shane J. Schaffer

Name:

Shane

J. Schaffer

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Cingulate

Issued First U.S. Patent for Lead ADHD Asset CTx-1301

Exclusivity

Extended into December 2042

Kansas

City, Kan., June 16, 2026 — 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 the issuance of its first company-owned U.S. patent covering its lead asset, CTx-1301 (dexmethylphenidate HCl), for the

treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The

patent, issued by the United States Patent and Trademark Office (USPTO) on June 16, 2026, as U.S. Patent No. 12,653,791, protects key

aspects of CTx-1301’s formulation and method of use through December 2042, further strengthening Cingulate’s intellectual

property portfolio surrounding its PTR™ platform.

The

issuance marks the first U.S. patent owned wholly by Cingulate covering CTx-1301 and further strengthens the company’s long-term

intellectual property position as it advances toward potential commercialization.

Titled

“Trimodal, Precision-Timed Pulsatile Release Tablet,” the patent includes composition-of-matter, formulation, structural

and method-of-treatment claims covering CTx-1301’s trimodal Precision Timed Release™ tablet technology. The patented design

enables medication release in three distinct phases throughout the day from a single daily dose and protects key aspects of the tablet’s

architecture, release mechanisms and therapeutic use.

“This

patent represents another important milestone in protecting the technology that differentiates CTx-1301 and underpins our proprietary

Precision Timed Release™ Platform,” said Cingulate CEO Shane J. Schaffer. “As we advance toward potential commercialization,

strengthening our intellectual property portfolio enhances the long-term value of CTx-1301 while supporting our goal of delivering consistent

symptom control throughout the entire active day from a single daily dose.”

addition to the U.S. patent, Cingulate currently holds patents in 30 European territories, including the United Kingdom, as well as in

Australia, Canada and Israel. The company also has patent applications pending in Hong Kong and the Republic of Korea.

Cingulate

is developing CTx-1301 and CTx-1302 as once-daily treatments for ADHD, with the goal of providing symptom control throughout the full

active day. Furthermore, Cingulate is developing CTx-2103, to treat anxiety disorders. CTx-2103 contains one of the most widely prescribed

anxiolytic agents which must be taken several times a day. CTx-2103 will be designed as a once-daily, multi-release tablet with clear

differentiation and compelling advantages over standard anxiety treatment options.

About

Attention Deficit/Hyperactivity Disorder (ADHD)

ADHD

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

market size of the US ADHD market is approximately 100 million annual prescriptions. 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.

About

CTx-1301

(dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™)

platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect

and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway.

About

Precision Timed Release™ (PTR™) Platform Technology

Cingulate

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.

About

Cingulate Inc.

Cingulate

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.

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. Specifically, these statements include, but are not limited to, the Company’s

long-term intellectual property position and the potential timing and process for regulatory approval of CTx-1301 and the potential commercialization

of CTx-1301, if approved. 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 18, 2026 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.

Investor

& Media Relations:

Thomas

Dalton

Vice

President, Corporate and Government Relations, Cingulate

tdalton@cingulate.com

(480)

529-5434

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