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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): August 6, 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)
(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.
Item
7.01. Regulation FD Disclosure.
On
August 6, 2025, Cingulate Inc. (the “Company”) issued a press release announcing that, on July 31, 2025, it submitted its
New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301 (dexmethylphenidate), the Company’s lead
asset for the treatment of attention deficit/hyperactivity (ADHD). 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
July 31, 2025, the Company submitted its NDA to the FDA for CTx-1301 (dexmethylphenidate), the Company’s lead asset for the treatment
of ADHD.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press release dated August 6, 2025 |
| |
|
|
| 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: August 6, 2025 |
By: |
/s/ Shane
J. Schaffer |
| |
Name: |
Shane J. Schaffer |
| |
Title: |
Chief Executive Officer |
