Cingulate Inc. — Regulatory Filings 2026

Jun 2, 2026

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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 ☒

If 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. ☐

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Item 7.01. Regulation FD Disclosure.

On 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.

On 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). |

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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. — By: | /s/ Shane
J. Schaffer |
| --- | --- |
| Name: | Shane J. Schaffer |
| Title: | Chief Executive Officer |

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