Form 8-K

8-K — Cingulate Inc.

Accession: 0001493152-26-037605

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001862150

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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

13, 2026

CINGULATE

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-40874

86-3825535

(State

or other jurisdiction of

incorporation)

(Commission

File

Number)

(IRS

Employer

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 ☒

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

2.02. Results of Operations and Financial Condition.

August 13, 2026, Cingulate Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026 and providing

a business update. A copy of the press release is furnished as Exhibit 99.1 and incorporated by reference. The information in this Item

2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for 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, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or

the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press Release dated August 13, 2026

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 13, 2026

By:

/s/

Jennifer L. Callahan

Name:

Jennifer

L. Callahan

Title:

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Cingulate

Inc. Reports Second Quarter 2026 Financial Results and Provides Update on CTx-1301 CMC Progress Towards NDA Resubmission and Commercial

Readiness

Cash

and Cash Equivalents of $28.4 Million as of June 30, 2026 Providing Runway Through Mid-2027; Company Advances Chemistry, Manufacturing

and Controls (CMC) Work Toward NDA Resubmission

KANSAS

CITY, Kan., August 13, 2026 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its

proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today

reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

“While

the regulatory process continues, our priorities remain clear: complete the remaining manufacturing work, submit a comprehensive response

to the FDA, and continue preparing the organization for commercialization,” said Cingulate Chairman and CEO Shane J. Schaffer.

“We believe CTx-1301 has the potential to address a significant unmet need in ADHD treatment, and we remain committed to bringing

this innovative therapy to patients as quickly as possible, pending FDA approval.”

Regulatory

Update: CTx-1301 NDA Resubmission Progress

Cingulate

continues to make progress on the CMC work needed to support resubmission of the NDA for CTx-1301 (dexmethylphenidate HCl), its lead

ADHD asset. The Company is working closely with its manufacturing partner to complete this work and plans to resubmit the NDA to the

FDA as promptly as practicable.

This

work follows a Complete Response Letter issued by the FDA on June 1, 2026, which identified specific requests for additional CMC information

and did not identify any concerns regarding the clinical safety or efficacy of CTx-1301.

Intellectual

Property Update

June 16, 2026, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,653,791 covering CTx-1301, following a Notice of Allowance

issued on March 17, 2026. The patent, titled “Trimodal, Precision-Timed Pulsatile Release Tablet,” includes composition-of-matter,

formulation, structural and method-of-treatment claims and protects key aspects of CTx-1301’s formulation and method of use through

December 2042. This is the first U.S. patent wholly owned by Cingulate covering CTx-1301, further strengthening the Company’s intellectual

property portfolio surrounding its PTR platform.

Commercial

Readiness Update

Cingulate

continues to advance commercialization preparations for CTx-1301, contingent upon FDA approval. Current activity is concentrated on market

access, payer readiness and manufacturing, the workstreams that must be advanced furthest ahead of any launch. Key areas of focus include:

●

Commercial

Manufacturing: Working with Bend Bioscience, the Company’s contract development and manufacturing organization, to complete

the requested CMC work and advance process validation for CTx-1301, which would serve as launch inventory if approved.

●

Product

Distribution: On July 21, 2026, the Company signed an exclusive services agreement with Prasco, LLC to establish the commercial distribution

infrastructure for the launch of CTx-1301, providing integrated third-party logistics and distribution capabilities designed to support

broad national availability across major wholesalers as well as direct distribution to approximately 19,000 independent and smaller

regional pharmacy accounts served under Prasco’s UNLIMIT program.

●

Market

Access and Payer Strategy: Advancing payer segmentation, value proposition, pricing and contracting strategy, and to support formulary

positioning ahead of a potential launch.

●

Commercial

Operations and Omnichannel Infrastructure: Building marketing, commercial operations and digital capabilities through the Company’s

master services agreement with Indegene, Inc., including dedicated market access, medical education, agency of record, and prescriber

and patient marketing teams.

●

Field

Deployment Planning: Under its agreement with IQVIA Inc., the Company will deploy field-based sales representatives in addition to

its currently deployed corporate account directors to align with the timing of a potential approval and launch.

Second

Quarter and First Half 2026 Financial Results

Cash

and Working Capital: As of June 30, 2026, Cingulate had approximately $28.4 million in cash and cash equivalents, compared to $11.0

million as of December 31, 2025. The increase was primarily driven by capital raised in the first and second quarters, including the

close of a $12.0 million private placement in the first quarter and $19.0 million of capital raised on Cingulate’s At-the-Market

Agreement with AGP and Purchase Agreement with Lincoln Park Capital, offset by $12.8 million in cash used for operations. Cingulate had

approximately $21.6 million in working capital as of June 30, 2026, an increase of $19.9 million as compared to December 31, 2025.

Under

its current business plan, the Company believes its cash and cash equivalents will be sufficient to fund operations into mid-2027, including

costs associated with completing the requested CMC work, seeking regulatory approval for CTx-1301, and continuing the build-out of commercial

readiness capabilities.

R&D

Expenses: Research and development (R&D) expenses were $1.5 million for the three months ended June 30, 2026, a decrease

of 44.9% from $2.7 million for the three months ended June 30, 2025, driven primarily by lower clinical operations costs following the

conclusion of clinical study activities in early 2025 and the absence of the increased regulatory costs incurred in the prior-year period

in connection with preparing the CTx-1301 NDA. For the six months ended June 30, 2026, R&D expenses were $3.7 million, a decrease

of 25.4% from $5.0 million for the six months ended June 30, 2025, partially offset by increased manufacturing activities and personnel

costs in the first half of 2026.

SG&A

Expenses: Selling, general and administrative (SG&A) expenses were $3.9 million for the three months

ended June 30, 2026, compared to $1.9 million for the three months ended June 30, 2025, an increase of 101.5%. For the six months ended

June 30, 2026, SG&A expenses were $9.7 million, compared to $3.4 million for the six months ended June 30, 2025, an increase of 181.7%.

The increases were driven primarily by the build-out of commercial readiness capabilities, including increased headcount and expanded

market access, pricing, reimbursement and medical affairs activity conducted through Indegene, the Company’s commercialization

partner.

Net

Loss: Net loss was $5.9 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June

30, 2025. For the six months ended June 30, 2026, net loss was $15.2 million, compared to $8.8 million for the six months ended June

30, 2025, primarily reflecting the increase in SG&A expenses described above.

Cingulate

Inc.

Consolidated

Balance Sheet Data

June 30,

December 31,

2026

2025

Cash and cash equivalents

$ 28,402,819

$ 10,953,383

Total assets

$ 33,066,321

$ 15,073,263

Total liabilities

$ 9,599,286

$ 12,564,356

Working Capital

$ 21,577,149

$ 1,695,633

Accumulated deficit

$ (147,557,384 )

$ (132,375,031 )

Total stockholders’ equity

$ 23,467,035

$ 2,508,907

Cingulate

Inc.

Consolidated

Statements of Operations

Three Months Ended June 30,

Six Months Ended June 30,

2026

2025

2026

2025

Operating expenses:

Research and development

$ 1,486,825

$ 2,700,939

$ 3,671,143

$ 4,923,565

Selling, general and administrative

3,928,150

1,949,035

9,667,054

3,432,444

Operating loss

(5,414,975 )

(4,649,974 )

(13,338,197 )

(8,356,009 )

Change in fair value of derivative

(314,013 )

(194,526 )

(1,166,043 )

(244,513 )

Interest and other income (expense), net

(141,276 )

(138,761 )

(678,113 )

(235,417 )

Loss before income taxes

(5,870,264 )

(4,983,261 )

(15,182,353 )

(8,835,939 )

Income tax benefit (expense)

Net loss

(5,870,264 )

(4,983,261 )

(15,182,353 )

(8,835,939 )

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 estimated

market size of the US ADHD market is approximately 100 million annual prescriptions. 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. According to the CDC, 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

(dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™)

platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect

and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway. In October

2025, the FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. On June 1, 2026, the

FDA issued a Complete Response Letter for the CTx-1301 NDA; the Company is working to complete the requested CMC work and plans to resubmit

the NDA as promptly as practicable. There can be no assurance regarding the timing of any resubmission or whether approval will occur.

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.

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, the timing and outcome of any resubmission of the CTx-1301 NDA, market opportunity, competitive

position, business strategies, potential growth opportunities, our expected cash runway, and anticipated capital needs and financing

plans. 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 18, 2026, our Quarterly Report on Form 10-Q for

the period ended June 30, 2026, 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 and Government Relations, Cingulate

tdalton@cingulate.com

(480)

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