Form 8-K

8-K — Cingulate Inc.

Accession: 0001493152-26-050870

Filed: 2026-11-10

Period: 2026-11-10

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): November 10, 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.

November 10, 2026, Cingulate Inc. (Company) issued a press release announcing that its Chairman and CEO, Shane J. Schaffer, in an interview

on Innovators with Jane King discusses the Company’s ongoing efforts to address the U.S. Food and Drug Administration’s

(FDA) Complete Response Letter (CRL) regarding the CTx-1301 new drug application (NDA), progress made to date, and the anticipated timeline

for NDA resubmission. A copy of the press release is attached hereto as Exhibit 99.1.

The

information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished

to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities

Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall

not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except

as shall be expressly set forth by a specific reference in such filing.

Item

8.01. Other Events.

October 2025, we announced that the FDA accepted for review our NDA for CTx-1301 and assigned a Prescription Drug User Fee Act (PDUFA)

targeted action date of May 31, 2026. On June 1, 2026, we received a CRL from the FDA regarding the NDA for CTx-1301. The CRL identified

specific requests for additional chemistry, manufacturing and controls (CMC) information and did not raise any concerns regarding the

clinical safety or efficacy of CTx-1301. We and our contract drug manufacturing organization have substantially completed the manufacturing

work required to address the CMC requests in the CRL and are finalizing the supporting data and documentation for a resubmission of the

NDA, which we currently expect to submit between December 2026 and January 2027. Upon receipt of a resubmission, the FDA is expected

to classify it as either a Class 1 or a Class 2 resubmission, carrying review goals of two months and six months, respectively. Subject

to receipt of FDA approval, we currently expect that the commercial launch of CTx-1301 could commence in the third quarter of 2027, although

there can be no assurance regarding the timing or occurrence of any such commercial launch. Moreover, there can be no assurance that

we will resubmit the NDA within the expected timeframe or at all, how the FDA will classify any resubmission, that any resubmission will

be accepted by the FDA, that approval of CTx-1301 will occur following any resubmission, or that approval will occur at all.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press release dated November 10, 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:

November 10, 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

Shane

Schaffer, Cingulate Chairman and CEO, Provides Update on CTx-1301 in Interview with Innovators with Jane King

KANSAS

CITY, Kan., November 10, 2026, — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision

Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products, announced today that Chairman

and CEO Shane J. Schaffer has provided an update on the regulatory progress of CTx-1301(dexmethylphenidate HCl), the company’s

lead asset for the treatment of attention deficit/hyperactivity disorder (ADHD).

an interview airing this morning on Innovators with Jane King, Dr. Schaffer discusses the company’s ongoing efforts to address

the FDA’s Complete Response regarding the CTx-1301 New Drug Application (NDA), progress made to date, and the anticipated timeline

for NDA resubmission.

“We

recognize that our shareholders have been waiting patiently for a meaningful update on CTx-1301, and we sincerely thank them for their

continued support, confidence, and commitment to Cingulate as we complete the work addressing the items in the FDA’s Complete Response.”

Innovators

with Jane King

Watch

Dr. Schaffer’s full interview:

Innovators

with Jane King

addition to discussing the anticipated NDA resubmission, Dr. Schaffer provides insight into Cingulate’s commercialization preparations

and highlights recent presentations he and Chief Commercial Officer Bryan Downey delivered at the Indegene Digital Summit, addressing

evolving strategies for pharmaceutical commercialization and successful product launches.

Indegene

Digital Summit

Watch

full-length discussions featuring Cingulate Chairman and CEO Shane J. Schaffer and Chief Commercial Officer Bryan Downey discussing commercialization

at the Indegene Digital Summit:

Chairman

& CEO Shane Schaffer presents the “Smart Launch” Approach

Chief

Commercial Officer Bryan Downey discusses “Reinventing the Launch Playbook”

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. In October

2025, the FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. On June 1, 2026, the

FDA issued a Complete Response Letter for the CTx-1301 NDA; the Company is working to complete the requested CMC work and plans to resubmit

the NDA as promptly as practicable. There can be no assurance regarding the timing of any resubmission or whether approval will occur.

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.

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, the timing and outcome of any resubmission of the CTx-1301 NDA, market opportunity, competitive

position, business strategies, potential growth opportunities, our expected cash runway, and anticipated capital needs and financing

plans. 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 Quarterly Report on Form 10-Q for

the period ended June 30, 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.

Investors

& Media:

Thomas

Dalton

Vice President, Corporate and Government Relations, Cingulate

tdalton@cingulate.com

(480) 529-5434

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