Form 8-K

8-K — Cingulate Inc.

Accession: 0001493152-26-026760

Filed: 2026-06-02

Period: 2026-06-02

CIK: 0001862150

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

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 2, 2026

CINGULATE

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-40874

86-3825535

(State or other jurisdiction

(Commission

(IRS Employer

of 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 2, 2026, Cingulate Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration

(“FDA”) has issued a Complete Response Letter (“CRL”) for its New Drug Application for CTx-1301 (dexmethylphenidate

HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (“ADHD”). A copy

of the press release 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

8.01 Other Events.

June 2, 2026, the Company announced that the FDA has issued a CRL for its New Drug Application for CTx-1301. The

FDA identified specific Chemistry, Manufacturing and Controls information requests in the CRL and did not raise any current

concerns regarding the clinical safety or efficacy of CTx-1301. The Company expects a prompt resubmission to FDA of the

remaining requested information addressing issues raised in the CRL.

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press

Release, dated June 2, 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 2, 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

Receives Complete Response Letter from FDA for CTx-1301

No Clinical Safety or Efficacy

Concerns Currently Identified

Agency

Feedback Primarily Focused on CMC-Related Requests

Company

Plans Prompt Response and Submission of Requested Information

Company

is Well Capitalized with Nearly $30 Million Cash on Hand

KANSAS

CITY, Kan., June 2, 2026 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™

(PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration

(“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301

(dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

The

response identified specific Chemistry, Manufacturing and Controls (CMC) information requests and did not raise any current concerns

regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing

issues raised.

“We

are encouraged that the FDA’s response was limited to specific information

requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301,” said

Cingulate CEO Shane J. Schaffer. “Our immediate priority is to complete the CMC work already underway with our manufacturing partner;

we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission. Importantly, we have nearly

$30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission

process and continue pre-commercial activities into 2027.”

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 U.S. 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

CTx-1301 (dexmethylphenidate HCI) 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. In October 2025, Cingulate announced that the U.S. Food and Drug Administration (FDA) had accepted for review the

New Drug Application (NDA) for CTx-1301 and had assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

NDA acceptance signifies that the FDA has determined the submission is sufficiently complete to permit substantive review. NDA acceptance

does not imply approval, nor does it guarantee any specific outcome or timing.

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 timing and process for regulatory approval of CTx-1301 and the potential timing of resubmission to FDA of requested information,

statements regarding our expected cash runway, and anticipated addressability of FDA requests. 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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