UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On June 29, 2023, Cingulate Inc. (the “Company”) issued a press release announcing the successful completion of manufacturing of clinical supply for its pivotal Phase 3 fixed-dose pediatric and adolescent study and its pivotal Phase 3 pediatric and adolescent dose-optimization classroom study to assess onset and durattion and efficacy and safety for its lead candidate, CTx-1301 (dexmethylphenidate), with the fixed-dose study scheduled to begin the week of July 24, 2023. 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 June 29, 2023, the Company announced the successful completion of manufacturing of clinical supply for its pivotal Phase 3 fixed-dose pediatric and adolescent study and its pivotal Phase 3 pediatric and adolescent dose-optimization classroom study to assess onset and durattion and efficacy and safety for its lead candidate, CTx-1301 (dexmethylphenidate), with the fixed-dose study scheduled to begin the week of July 24, 2023.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release dated June 29, 2023 | |
| 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 29, 2023 | By: | /s/ Shane J. Schaffer |
| Name: | Shane J. Schaffer | |
| Title: | Chief Executive Officer | |