Cingulate Inc. — Regulatory Filings 2025

Mar 4, 2025

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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): March 4, 2025

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)

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(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 one share of 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 March 4, 2025, Cingulate Inc. (the “Company”) issued a press release announcing safety results from the final trials for its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity (ADHD), upon approval from the U.S. Food and Drug Administration (FDA). 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.

On March 4, 2025, the Company announced safety results from the Phase 3 trials for its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD, upon approval from the FDA.

An analysis of the data revealed the following:

| ● | No
subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE
or a TEAE leading to death |
| --- | --- |
| ● | There
were no clinically relevant trends in TEAEs overall |
| ● | The
pharmacokinetics of the food effect study are being analyzed; however the medical findings
are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301
could be taken with or without food |

A final analysis that combines both adult and pediatric safety and efficacy data is expected to be announced mid-2025 and will be included in the NDA submission to the FDA.

As of March 4, 2025, the Company had 3,647,655 shares of its common stock issued and outstanding.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

| Exhibit
No. | Description |
| --- | --- |
| 99.1 | Press release dated March 4, 2025 |
| 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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