# EDGAR Filing Document

**Accession Number:** 0001862150
**File Stem:** 0001641172-25-022360
**Filing Date:** 2025-8
**Character Count:** 13442
**Document Hash:** 67989b72a343811a71df8de5079b3ccc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-022360.hdr.sgml**: 20250806

**ACCESSION NUMBER**: 0001641172-25-022360

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250806

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250806

**DATE AS OF CHANGE**: 20250806

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cingulate Inc.
- **CENTRAL INDEX KEY:** 0001862150
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 863825535
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40874
- **FILM NUMBER:** 251187745

**BUSINESS ADDRESS:**
- **STREET 1:** 1901 W. 47TH PLACE
- **CITY:** KANSAS CITY
- **STATE:** KS
- **ZIP:** 66205
- **BUSINESS PHONE:** (913) 942-2300

**MAIL ADDRESS:**
- **STREET 1:** 1901 W. 47TH PLACE
- **CITY:** KANSAS CITY
- **STATE:** KS
- **ZIP:** 66205

?xml version='1.0' encoding='ASCII'?

**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)*

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40874** | **86-3825535** |
| *(State or other jurisdiction* | *(Commission* | *(IRS Employer* |
| *of incorporation)* | *File Number)* | *Identification No.)* |

---

---

| | |
|:---|:---|
| **1901 W. 47th Place**<br> **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<br> (Nasdaq Capital Market) |
| Warrants, exercisable for common stock | CINGW | The Nasdaq Stock Market LLC<br> (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](ex99-1.htm) |
| 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.** | **CINGULATE INC.** |
| Dated: August 6, 2025 | By: | */s/ Shane J. Schaffer* |
|  | Name: | Shane J. Schaffer |
|  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301** 

*Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients*

KANSAS CITY, Kan., August 6, 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, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301(dexmethylphenidate HCl), the company's lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. Cingulate may learn if the NDA has been accepted for review by the FDA within 60 days of its July 31 submission.

"The submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development focused on delivering a true, once-daily ADHD treatment that offers fast onset, entire active-day efficacy, and a consistent therapeutic experience," said Cingulate Chief Medical Officer Matthew Brams, MD. "We believe CTx-1301 addresses key limitations of existing therapies and has the potential to improve outcomes for patients across age groups."

Shane J. Schaffer, Chairman and CEO of Cingulate, stated, "With a differentiated profile supported by robust clinical data, we believe CTx-1301 has the potential to capture meaningful share in the $23 billion U.S. ADHD market, bringing us closer to delivering long-term value for our shareholders as we transition from a development-stage company to a commercial organization. Just as important, this NDA submission represents the first regulatory application of our proprietary Precision Timed Release™ platform – an innovative and scalable technology we believe can provide significant pipeline value across multiple indications where unmet needs remain high."

**About Attention Deficit/Hyperactivity Disorder (ADHD)**

ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. **<u>According to the CDC</u>**, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.

**About CTx-1301**

Cingulate's lead candidate, CTx-1301, utilizes Cingulate's proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

**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 **<u>here</u>**.

**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 **<u>Cingulate.com</u>**.

**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 & Media Relations:**

Thomas Dalton

Vice President, Corporate Communications, Cingulate

**<u>tdalton@cingulate.com</u>**

(913) 942-2301