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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):
April 8, 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 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. ☐
Item 1.01. Entry Into a Material Definitive Agreement.
On April 8, 2025, Cingulate Inc., through its wholly-owned subsidiary, Cingulate Therapeutics LLC (collectively, the “Company”), entered into a Grant Agreement (the “Agreement”) with a private family foundation (the “Foundation”).
Pursuant to the Agreement, the Company will receive a grant of $3 million in three equal payments of $1 million (the “Grant Funds”) to support the clinical and manufacturing development of CTx-2103 (Buspirone) (the “Purpose”). The first payment will be received by the Company on May 1, 2025, the second payment will be received by the Company upon completion of a formulation study for CTx-2103, and the third payment will be received by the Company upon completion of development batches required for CTx-2103. The Company is not required to return any Grant Funds received from the Foundation unless the Purpose has ended, in which case Company will return any remaining Grant Funds to the Foundation. The Company will pay the Foundation a royalty, contingent on the commercialization of CTx-2103, of $500,000 per quarter, beginning six months after the first sale of CTx-2103, with a maximum cumulative payout of $3.5 million.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which has been filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company has redacted certain information from the Agreement because such information is not material and is the type that the Company treats as private or confidential.
Item 7.01. Regulation FD Disclosure.
On April 9, 2025, the Company issued a press release announcing the Grant Agreement. A copy of the press release is furnished as Exhibit 99.1 and incorporated by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description |
|
| 10.1 | ||
| 99.1 | ||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).
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: April 9, 2025 | By: | /s/ Shane J. Schaffer |
| Name: | Shane J. Schaffer | |
| Title: | Chief Executive Officer | |
Exhibit 10.1
Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”
GRANT AGREEMENT
THIS GRANT AGREEMENT (this “Agreement”) dated April 8, 2025
BETWEEN:
[***]
AND
Cingulate Therapeutics, LLC of 1901 W. 47th Place, 3rd Floor, Kansas City, KS 66205
| 1) | Grantor – [***] (“Foundation”) | |
| 2) | Grantee – Cingulate Therapeutics, LLC (“Cingulate”) | |
| 3) | Grant Funds – $3,000,000 to be received in three installments: |
| ● | $1,000,000 on May 1, 2025 , | |
| ● | $1,000,000 upon completion of formulation study for CTx-2103, and | |
| ● | $1,000,000 upon completion of development batches required for CTx-2103 IND |
Except for the right to receive royalties upon commercialization of CTx-2103, Foundation shall not receive anything in return for the Grant Funds.
| 4) | Use of Proceeds – The Grant Funds will be expended to support the clinical and manufacturing development of CTx-2103 (Buspirone) (the “Purpose”) as outlined in Exhibit 1. Cingulate shall not be required to return any Grant Funds received from Foundation unless the Purpose has ended, in which case Cingulate will return any remaining Grant Funds to Foundation. | |
| 5) | Recordkeeping and Reporting – Cingulate shall maintain records of receipts and expenditures of the Grant Funds and shall make such records available to Foundation for informational purposes, upon its reasonable request. | |
| 6) | Intellectual Property – Any intellectual property created or developed in connection with the Purpose, including through Cingulate’s use of the Grant Funds, shall be Cingulate’s sole property and Cingulate shall hold all rights therein. | |
| 7) | No Joint Venture – The grant by Foundation to Cingulate shall not be construed in any manner to imply or create a relationship between Foundation and Cingulate as partners, joint ventures or agents. Neither party shall have authority to make any statements, representation, or commitments of any kind, or to take any action which shall be binding on the other party. | |
| 8) | Royalty – Foundation will receive a future royalty contingent on the commercialization of CTx-2103. In the event that Cingulate receives sales revenue or royalty payments under a sublicense agreement from CTx-2103, Foundation will receive a royalty of $500,000 per quarter, beginning six months after the first sale of CTx-2103, with a maximum cumulative pay-out of $3,500,000. | |
| 9) | Governing Law – This Agreement will be construed in accordance with and governed by the laws of the State of Texas. | |
| 10) | Amendments – This Agreement may only be amended or modified by a written instrument executed by both the parties. | |
| 11) | Entire Agreement – This Agreement and the Confidentiality Agreement, dated December 20, 2024, between the parties constitute the entire agreement between the parties and there are no further items or provisions, either oral or otherwise. |
[Signature page follows]
|
|
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed as of the date set forth above by their duly authorized representatives.
| Foundation | Cingulate | |||
| By | [***] | By | /s/ Shane Schaffer | |
| Name | [***] | Name | Shane Schaffer | |
| Title | [***] | Title | CEO | |
|
|
EXHIBIT 1
[CTx-2103 Clinical and Manufacturing Development]
[***]
|
|
Exhibit 99.1
Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the $5.5 Billion U.S. Anxiety Market, and the $11.6 Billion Anxiety Market Worldwide
Non-Dilutive Funding Expands Pipeline and Further Validates Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Technology
CTx-2103 has the Potential to Reduce Use of Benzodiazepine’s and Associated Withdrawal and Dependency Issues
KANSAS CITY, Kan., April 9, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has received a $3 million grant to accelerate the development of CTx-2103 (buspirone) for the treatment of anxiety. CTx-2103 has the potential to be the first, once-daily formulation of buspirone, one of the most widely prescribed agents in the $5.5 billion U.S. anxiety market ($11.6 billion global).
The grant will be made in three tranches of $1 million each, the first tranche to be paid on May 1st , and the two subsequent tranches payable based on specified product development milestones. The foundation will receive a future royalty contingent on the commercialization of CTx-2103, beginning six months after the after the first commercial sale of CTx-2103, payable at $500,000 per quarter, with a maximum cumulative royalty of $3.5 million.
“This grant was made by a private foundation whose foremost interest is combating the global rise of critical health issues such as anxiety in a consequential way. We thank the foundation for this funding for the development of CTx-2103, which advances Cingulate’s pipeline and illustrates the applicability of our PTR™ platform. Today, we are one step closer to providing the first, once-daily medicine for the millions of patients worldwide who suffer from anxiety-related disorders, the most common mental health issue in America and around the world,” said Cingulate Chairman and CEO Shane J. Schaffer.
According to the National Institutes of Mental Health (NIMH), anxiety disorders are the most common mental health concern in the U.S. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. 1
About CTx-2103
CTx-2103 is a novel, multi-release tablet of buspirone that incorporates Cingulate’s proprietary PTR™ drug delivery platform. CTx-2103 is being studied for the treatment of anxiety and/or anxiety-related disorders. Buspirone, an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid receptors.
About Anxiety
Anxiety disorders are the most common mental health concern in the U.S.1 Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related disorders and as a result is a priority within the class of unmet medical needs in mental health.1
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 where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
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, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. 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 27, 2025, 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.
Investor & Public Relations:
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
(214) 597-8200