UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from________ to_________.

Commission File Number: 001-40874

Cingulate Inc.

(Exact name of registrant as specified in its charter)

Delaware		86-3825535
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

1901 W. 47^th Place Kansas City, KS		66205
(Address of principal executive offices)		(Zip Code)

(913) 942-2300

(Registrant’s telephone number, including area code)

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 shares of common stock

CINGW

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 15, 2025, 5,412,523 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.

Cingulate Inc.

Form 10-Q for the Quarter Ended June 30, 2025

TABLE OF CONTENTS

		Page
	PART I
Item 1	Financial Statements	4
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4	Controls and Procedures	29

	PART II
Item 1	Legal Proceedings	30
Item 1A	Risk Factors	30
Item 5	Other Information	30
Item 6	Exhibits	31

Signatures		32

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

This report 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, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of filing this report with the Securities and Exchange Commission (SEC) and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about the following:

	●	our ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market LLC (Nasdaq);

	●	our lack of operating history and need for additional capital;

	●	our plans to develop and commercialize our product candidates;

	●	the timing of our planned clinical trials for CTx-1301, CTx-1302, and CTx-2103;

	●	the timing of our New Drug Application (NDA) submissions for CTx-1302 and CTx-2103;

	●	the timing of and our ability to obtain and maintain regulatory approvals for CTx-1301, CTx-1302, CTx-2103, or any other future product candidate;

	●	the clinical utility of our product candidates;

	●	our commercialization, marketing and manufacturing capabilities and strategy;

	●	our ability to identify strategic partnerships;

	●	our expected use of cash;
	●	our competitive position and projections relating to our competitors or our industry;
	●	our ability to identify, recruit, and retain key personnel;

	●	the impact of laws and regulations;

	●	our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act);

	●	our plans to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives; and

	●	our estimates regarding future revenue and expenses.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should refer to the “Risk Factors” section in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time. It is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC.

PART I — FINANCIAL INFORMATION

Cingulate Inc.

Consolidated Balance Sheets (unaudited)

	June 30,			December 31,
	2025			2024
ASSETS

Current assets:
Cash and cash equivalents	$	8,900,183		$	12,211,321
Other receivables		19,585			26,325
Prepaid expenses and other current assets		1,302,900			423,157
Total current assets		10,222,668			12,660,803

Property and equipment, net		1,798,320			2,104,675
Operating lease right-of-use assets		1,447,220			99,011

Total assets		13,468,208			14,864,489

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Accounts payable		872,853			1,270,280
Accrued expenses		501,786			1,039,625
Note payable, current		5,134,475			2,527,108
Finance lease liability, current		-			4,430
Operating lease liability, current		223,633			130,662
Total current liabilities		6,732,747			4,972,105

Long-term liabilities:
Operating lease liability, net of current		1,223,587			-
Note payable		-			2,436,879
Total long-term liabilities		1,223,587			2,436,879
Total liabilities		7,956,334			7,408,984

Stockholders’ Equity
Common Stock, $0.0001 par value; 240,000,000 shares authorized and 4,889,290 and 3,402,306 shares issued and outstanding as of June 30, 2025 and December 31, 2024		488			340
Preferred Stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of June 30, 2025 and December 31, 2024		-			-
Additional Paid-in-Capital		122,591,992			115,944,345
Accumulated deficit		(117,080,606	)		(108,489,180	)
Total stockholders’ equity		5,511,874			7,455,505

Total liabilities and stockholders’ equity	$	13,468,208		$	14,864,489

See notes to unaudited consolidated financial statements.

Cingulate Inc.

Consolidated Statements of Operations and Comprehensive Loss (unaudited)

	2025			2024			2025			2024
	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	2,700,939		$	1,881,093		$	4,923,565		$	3,688,078
General and administrative		1,949,035			1,325,087			3,432,444			2,466,319
Operating loss		(4,649,974	)		(3,206,180	)		(8,356,009	)		(6,154,397	)

Interest and other income (expense), net		(138,761	)		(3,497	)		(235,417	)		(27,757	)
Loss before income taxes		(4,788,735	)		(3,209,677	)		(8,591,426	)		(6,182,154	)
Income tax benefit (expense)		-			-			-			-

Net loss and comprehensive loss	$	(4,788,735	)	$	(3,209,677	)	$	(8,591,426	)	$	(6,182,154	)

Net loss per share of common stock, basic and diluted	$	(1.09	)	$	(5.47	)	$	(2.14	)	$	(12.28	)

Weighted average number of shares used in computing net loss per share of common stock, basic and diluted		4,389,465			586,313			4,020,231			503,598

See notes to unaudited consolidated financial statements.

Cingulate Inc.

Consolidated Statements of Stockholders’ Equity (unaudited)

	Shares		Amount		Capital			Deficit			Income		Equity
											Accumulated
	Common Stock				Additional Paid-in-			Accumulated			Other Comprehensive		Stockholders’
	Shares		Amount		Capital			Deficit			Income		Equity
Balance January 1, 2024		97,293		10	$	86,074,004		$	(92,943,443	)	$	-	$	(6,869,429	)
Activity for the three months to March 31, 2024:
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees		23,650		2		3,115,282			-			-		3,115,284
Issuance of common stock in public offering, net of fees		296,000		30		6,432,862			-			-		6,432,892
Issuance of pre-funded warrants in connection with the conversion of related party note payable		-		-		2,734,739			-			-		2,734,739
Capital contribution in connection with conversion of related party note payable		-		-		586,511			-			-		586,511
Issuance of restricted common stock		596		-		24,024			-			-		24,024
Stock-based compensation expense		-		-		164,575			-			-		164,575
Net loss		-		-		-			(2,972,477	)		-		(2,972,477	)
Balance March 31, 2024		417,539	$	42	$	99,131,997		$	(95,915,920	)	$	-	$	3,216,119
Activity for the three months to June 30, 2024:
Issuance of common stock upon exercise of pre-funded warrants		86,334		9		(9	)		-			-		-
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees		121,279		12		1,109,990			-			-		1,110,002
Warrant inducement		143,958		14		1,614,549			-			-		1,614,563
Issuance of restricted common stock		11,652		1		98,433			-			-		98,434
Stock-based compensation expense		-		-		254,331			-			-		254,331
Net loss		-		-		-			(3,209,677	)		-		(3,209,677	)
Balance June 30, 2024		780,762	$	78	$	102,209,291		$	(99,125,597	)	$	-	$	3,083,772

Balance January 1, 2025		3,402,306	$	340	$	115,944,345		$	(108,489,180	)	$	-	$	7,455,505
Activity for the three months to March 31, 2025:
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees		423,893		42		1,920,315			-			-		1,920,357
Stock-based compensation expense		-		-		357,649			-			-		357,649
Net loss		-		-		-			(3,802,691	)		-		(3,802,691	)
Balance March 31, 2025		3,826,199	$	382	$	118,222,309		$	(112,291,871	)	$	-	$	5,930,820
Balance		3,826,199	$	382	$	118,222,309		$	(112,291,871	)	$	-	$	5,930,820
Activity for the three months to June 30, 2025:
Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees		1,038,969		104		4,182,295			-			-		4,182,399
Issuance of restricted common stock		24,122		2		96,667			-			-		96,669
Stock-based compensation expense		-		-		90,721			-			-		90,721
Net loss		-		-		-			(4,788,735	)		-		(4,788,735	)
Balance June 30, 2025		4,889,290	$	488	$	122,591,992		$	(117,080,606	)	$	-	$	5,511,874
Balance		4,889,290	$	488	$	122,591,992		$	(117,080,606	)	$	-	$	5,511,874

See notes to unaudited consolidated financial statements.

Cingulate Inc.

Consolidated Statements of Cash Flows (unaudited)

	2025			2024
	Six Months Ended June 30,
	2025			2024
Operating activities:
Net loss	$	(8,591,426	)	$	(6,182,154	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		312,280			327,381
Stock-based compensation		545,039			541,349
Accretion of discount on note payable		15,353			-
Amortization of debt issue costs		155,135			-
Changes in operating assets and liabilities:
Other receivables		6,740			12,375
Prepaid expenses and other current assets		(879,743	)		(6,682	)
Operating lease right-of-use assets		(1,348,209	)		128,662
Trade accounts payable and accrued expenses		(935,266	)		(5,137,926	)
Current portion of operating lease liability		92,971			(40,742	)
Long-term portion of operating lease liability		1,223,587			(130,663	)
Net cash used in operating activities		(9,403,539	)		(10,488,400	)

Investing activities:
Purchase of property and equipment		(5,925	)		(154,133	)
Net cash used in investing activities		(5,925	)		(154,133	)
Financing activities:
Proceeds from the issuance of common stock and pre-funded common stock purchase warrants, net of fees		6,102,756			10,979,443
Principal payments on finance lease obligations		(4,430	)		(8,398	)
Net cash provided by financing activities		6,098,326			10,971,045

Cash and cash equivalents:
Net increase (decrease) in cash and cash equivalents		(3,311,138	)		328,512
Cash and cash equivalents at beginning of year		12,211,321			52,416
Cash and cash equivalents at end of period	$	8,900,183		$	380,928

Property and equipment accrued but not yet paid at end of period	$	-		$	220,370
Cash payments:
Interest paid	$	16,250		$	5,975

See notes to unaudited consolidated financial statements

CINGULATE INC.

Notes to Consolidated Financial Statements

(1) Nature of the Business and Liquidity

Organization

Cingulate Inc. (Cingulate, or the Company), a Delaware corporation, is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active day with a controlled descent of plasma drug level and have favorable tolerability. In addition, the Company has a third product to treat anxiety, CTx-2103, in a formulation stage.

The consolidated financial statements and notes for the periods ended June 30, 2025 and 2024, represent the full consolidation of Cingulate and its subsidiaries, including Cingulate Therapeutics LLC (CTx) and all references to the Company represent this full consolidation.

Liquidity

The Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent on the ability to raise capital to support operations until such time as the product candidates under development are U.S. Food and Drug Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. On June 30, 2025, the Company had cash and cash equivalents of approximately $8.9 million, and an accumulated deficit of approximately $117.1 million. However, the Company will need additional funding for operations and development. Management is evaluating various strategies to obtain additional funding, which may include additional offerings of equity, issuance of debt, or other capital sources, including potential collaborations with other companies or other strategic transactions. Successful implementation of these plans involves both the Company’s efforts and factors that are outside its control, such as market factors and FDA approval of product candidates. The Company can give no assurance that its plans will be effectively implemented in such a way that they will sufficiently alleviate or mitigate the conditions and events noted above, which results in substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty.

(2) Summary of Significant Accounting Policies

(a) Basis of Presentation and Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

(b) Unaudited Interim Financial Information

The accompanying consolidated balance sheets as of June 30, 2025 and December 31, 2024, the consolidated statements of operations and comprehensive loss for the three and six-month periods ended June 30, 2025 and 2024, the consolidated statements of stockholders’ equity for the three and six-month periods ended June 30, 2025 and 2024, the consolidated statements of cash flows for the six-month periods ended June 30, 2025 and 2024, and the related interim disclosures are unaudited. These unaudited consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying consolidated financial statements should be read in conjunction with the Company’s 2024 audited consolidated financial statements and the notes thereto.

(c) Concentration of Credit Risk

The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $250,000 (without regard to reconciling items). Management monitors the soundness of these financial institutions and does not believe the Company is subject to any material credit risk relative to the uninsured portion of the deposits.

(d) Impairment of Long-lived Assets

The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease right of use (ROU) assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the six-month periods ended June 30, 2025 or 2024.

(e) Stock-Based Compensation

The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 10.

(f) Segments

Operating segments are defined as components of an enterprise for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company manages its business activities on a consolidated basis and operates as a single operating segment dedicated to the research and development and manufacturing of its product candidates. The Company’s CODM is its Chief Executive Officer. The CODM uses net loss, as reported in the Company’s Consolidated Statements of Operations and Comprehensive Loss, in evaluating performance of its segment and determining how to allocate resources of the Company as a whole, including investing in its research and development activities.

The measure used by the CODM for segment assets is reported in the Consolidated Balance Sheets as total consolidated assets.

The following table presents the operating results of the Company’s segment:

	2025			2024			2025			2024
	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Operating expenses:
Research and development
Clinical operations	$	763,860		$	65,966		$	1,871,334		$	1,143,156
Drug manufacturing and formulation		1,110,084			1,462,519			1,490,437			1,803,718
Personnel		409,220			343,762			970,554			649,714
Regulatory		417,775			8,846			591,240			91,490
Total research and development		2,700,939			1,881,093			4,923,565			3,688,078
General and administrative
Personnel		459,336			404,586			1,030,866			817,863
Legal and professional fees		968,987			494,468			1,474,487			810,153
Occupancy		88,359			73,846			149,986			174,533
Insurance		174,449			241,524			370,045			483,048
Other		257,904			110,663			407,060			180,722
Total general and administrative		1,949,035			1,325,087			3,432,444			2,466,319
Operating loss		(4,649,974	)		(3,206,180	)		(8,356,009	)		(6,154,397	)
Interest and other income (expense), net		(138,761	)		(3,497	)		(235,417	)		(27,757	)
Loss before income taxes		(4,788,735	)		(3,209,677	)		(8,591,426	)		(6,182,154	)
Income tax benefit (expense)		-			-			-			-

Net loss and comprehensive loss	$	(4,788,735	)	$	(3,209,677	)	$	(8,591,426	)	$	(6,182,154	)

(3) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following at June 30, 2025 and December 31, 2024:

	June 30,		December 31,
	2025		2024
Materials	$	889,185	$	29,025
Professional fees		223,918		-
Marketing fees		125,000		-
Dues and subscriptions		26,500		4,575
Insurance		17,597		-
Research and development		-		334,692
Other		20,700		54,865
	$	1,302,900	$	423,157

(4) Property and Equipment

Property and equipment, net consisted of the following at June 30, 2025 and December 31, 2024:

Schedule of Property and Equipment

	Estimated
	Useful Life		June 30,			December 31,
	(in years)		2025			2024
Equipment		2-7	$	4,358,261		$	4,358,261
Furniture and fixtures		7		145,754			145,754
Computer equipment		5		46,994			46,994
Leasehold improvements		5		474,462			474,462
Construction-in-process- equipment		-		381,203			375,278
Property and equipment, gross				5,406,674			5,400,749
Less: accumulated depreciation				(3,608,354	)		(3,296,074	)
Property and equipment, net			$	1,798,320		$	2,104,675

Depreciation expense was $312,280 and $327,381, respectively, for the six-month periods ended June 30, 2025 and 2024. Depreciation expense was $146,989 and $163,781, respectively, for the three-month periods ended June 30, 2025 and 2024.

(5) Accrued Expenses

Accrued expenses consisted of the following at June 30, 2025 and December 31, 2024:

Schedule of Accrued Expenses

	June 30,		December 31,
	2025		2024
Interest	$	267,984	$	15,089
State franchise taxes		102,000		200,000
Research and development		96,216		341,956
Employee compensation		-		355,475
Insurance		-		34,469
CIP- Equipment		-		31,160
Professional fees		-		5,000
Other		35,586		56,476
Total accrued expenses	$	501,786	$	1,039,625

(6) Contingencies

The Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise. A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations.

The Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, Contingencies. If a range of loss is estimated, and some amount within that range appears to be a better estimate than any other amount within that range, then that amount is accrued. If no amount within the range can be identified as a better estimate than any other amount, we accrue the minimum amount in the range. These amounts are not reduced by amounts that may be recovered under insurance or claims against third parties, but undiscounted receivables from insurers or other third parties may be accrued separately if recovery is considered probable. Management’s judgment is required related to loss contingencies because the outcomes are difficult to predict, and the ultimate resolution may differ from our current analysis. The Company revises accruals in light of new information. While it is not possible to predict the outcome of loss contingencies with certainty, management is of the opinion that adequate provision for potential losses associated with any such matters has been made in the financial statements. No accruals for loss contingencies were recorded in the consolidated balance sheets as of June 30, 2025 or December 31, 2024.

In December 2023, the Company implemented salary reductions for all employees and the Board approved a contingent bonus plan in which the Company will pay to each employee three months after the filing date of the New Drug Application for CTx-1301, an amount equal to the base salary that was not paid to the employee plus 20%. Base salaries were reinstated in September 2024. This contingent bonus had not yet been deemed probable as of June 30, 2025 per the requirements of ASC Topic 450, Contingencies, thus was not recorded in the financial statements; however, it is reasonably possible that it will become due. The unpaid salary amounts plus 20%, estimated to be $722,824, may be paid in a combination of cash and equity awards, at the discretion of the Board.

(7) Unsecured Promissory Note

On December 20, 2024, the Company entered into a note purchase agreement with Streeterville Capital, LLC, a Utah limited liability company (Lender), pursuant to which the Company issued and sold to Lender an unsecured promissory note (Promissory Note) in the amount of $5,480,000. The Promissory Note included an original issue discount of $450,000 and Lender expenses payable by the Company of $30,000. In exchange for the Promissory Note, the Lender paid a purchase price of $5,000,000 in cash. The Promissory Note bears interest at a rate of 9% per annum and matures 18 months after its issuance date.

From time to time, beginning on July 2, 2025, Lender may redeem a portion of the Promissory Note, not to exceed an amount of $550,000 per month. On the 90-day anniversary of the effective date of the Promissory Note, the Company was charged a monitoring fee equal to the outstanding principal balance on such date divided by 0.85 less the outstanding balance on such date. The monitoring fee and interest accrued on the monitoring fee will be forgiven, on a pro rata basis, each time the Company makes a cash payment on the Promissory Note. Subject to the terms and conditions set forth in the Promissory Note, the Company may prepay all or any portion of the outstanding balance of the Promissory Note at any time.

The Promissory Note provides for customary events of default (each, an Event of Default), including, among other things, the event of nonpayment of principal, interest, fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants within a specified cure period, a cross-default to certain other indebtedness and material agreements of the Company, and the occurrence of a bankruptcy, insolvency or similar event affecting the Company. Upon the occurrence of an Event of Default that is deemed a “Major Trigger Event” as defined in the Promissory Note, Lender may increase the outstanding balance of the Promissory Note by 15%, and upon the occurrence of an Event of Default that is deemed a “Minor Trigger Event” as defined in the Promissory Note, Lender may increase the outstanding balance of the Promissory Note by 5%. Lender can exercise its right to increase the outstanding balance upon a Major or Minor Trigger Event three times each. Upon the occurrence of an Event of Default, Lender may declare all amounts owed under the Promissory Note immediately due and payable. In addition, upon the occurrence of an Event of Default, upon the election of Lender, interest shall begin accruing on the outstanding balance of the Promissory Note from the date of the Event of Default equal to the lesser of 22% per annum and the maximum rate allowable under law.

In connection with the Promissory Note, the Company incurred $46,277 of debt issuance costs. The debt issuance costs, the debt discount of $450,000 and the expenses payable by the Company of $30,000 have been recorded as a reduction in the carrying amount of the Promissory Note and are being amortized over the term of the Promissory Note using the effective interest rate method. As of June 30, 2025, the collective amount of unamortized debt discount and debt issuance costs were $345,525.

As of June 30, 2025, the outstanding principal balance of the Promissory Note plus accrued interest was $5,747,984.

The following table provides a breakdown of interest expense (income) for the periods presented:

Schedule of Interest Expense (Income)

	2025			2024			2025			2024
	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Interest expense - Streeterville Capital	$	213,711		$	-		$	423,382		$	-
Interest expense - other		16,250			5,667			16,295			5,975
Interest expense - WFIA		-			-			-			31,250
Interest expense		-			-			-			31,250
Interest income		(93,031	)		(2,170	)		(205,963	)		(9,468	)
Total	$	136,930		$	3,497		$	233,714		$	27,757

(8) Stockholders’ Equity

The Company has authorized 240,000,000 shares of $0.0001 par value common stock and 10,000,000 shares of $0.0001 par value preferred stock at June 30, 2025 and December 31, 2024, of which 4,889,290 and 3,402,306 shares of common stock were issued and outstanding, respectively. The Company has not issued any shares of preferred stock.

The holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Holders of shares of common stock are entitled to dividends when, as and if declared by the Board of Directors.

Reverse Stock Splits

On November 30, 2023, the Company completed a one-for-twenty reverse stock split (2023 Reverse Stock Split), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the 2023 Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the 2023 Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the 2023 Reverse Stock Split.

On August 9, 2024, the Company completed a one-for-twelve reverse stock split (2024 Reverse Stock Split), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the 2024 Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the 2024 Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the 2024 Reverse Stock Split.

Except where disclosed, all amounts related to number of shares and per share amounts have been retrospectively restated in these financial statements to reflect the 2023 Reverse Stock Split and the 2024 Reverse Stock Split.

(9) Securities Issuances

At the Market Offering

The Company entered into the At-the-Market Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW) in January 2023, as amended in May 2023, pursuant to which the Company can issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $23.5 million in at-the-market offerings sales. HCW acts as sales agent and is paid a 3% commission on each sale under the ATM Agreement. The Company’s common stock is sold at prevailing market prices at the time of the sale, and, as a result, prices will vary.

During the three months ended June 30, 2025 and 2024, the Company sold 364,963 and 31,858 shares of common stock, respectively, under the ATM Agreement, for net proceeds of $1,578,731 and $354,259. During the six months ended June 30, 2025 and 2024, the Company sold 565,447 and 55,858 shares of common stock, respectively, under the ATM Agreement, for net proceeds of $2,599,099 and $3,469,543.

Purchase Agreement with Lincoln Park

In April 2023, the Company entered into a purchase agreement (the Original LP Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement) with Lincoln Park Capital Fund, LLC (Lincoln Park). Pursuant to the terms of the Original LP Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $12 million of the Company’s common stock subject to certain limitations and satisfaction of the conditions set forth in the Original LP Purchase Agreement. Pursuant to the terms of the Registration Rights Agreement, the Company filed with the SEC registration statements to register for resale under the Securities Act 2,685,417 shares of common stock that have been or may be issued to Lincoln Park under the Original LP Purchase Agreement.

During the three months ended June 30, 2025 and 2024, the Company sold 674,006 and 89,420 shares of common stock under the Original LP Purchase Agreement, for net proceeds of $2,613,247 and $755,703. During the six months ended June 30, 2025 and 2024, the Company sold 897,415 and 89,420 shares of common stock under the Original LP Purchase Agreement, for net proceeds of $3,513,236 and $755,703. As of June 30, 2025, the Company sold to Lincoln Park the maximum dollar value worth of common stock pursuant to the Original LP Purchase Agreement, and the Original LP Purchase Agreement thereupon expired in accordance with its terms.

(10) Stock-Based Compensation

In September 2021, the Company’s board of directors and stockholders adopted the 2021 Equity Incentive Plan (the 2021 Plan), which provides for the grant of incentive stock options and non-qualified stock options to purchase shares of the Company’s common stock, stock appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance units, incentive bonus awards, other stock-based awards and other cash-based awards. No awards may be made under the 2021 Plan on or after September 24, 2031, but the 2021 Plan will continue thereafter while previously granted awards remain outstanding.

At the Company’s 2024 annual meeting, shareholders approved an amendment to the 2021 Plan to increase the number of shares of common stock authorized for issuance thereunder by 104,167 shares to 125,577. At the Company’s 2025 annual meeting, shareholders approved an amendment to the 2021 Plan to increase the number of shares of common stock authorized for issuance thereunder by 800,000 shares to 1,141,826. As of June 30, 2025, 743,000 shares of common stock were available for issuance under the 2021 Plan. The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a lesser number of shares of common stock than would otherwise occur. The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2021 Plan will be added back to the shares of common stock available for issuance under the 2021 Plan.

The Company recorded stock-based compensation expense of $448,370 and $418,906 during the six months ended June 30, 2025 and 2024, respectively. The Company recorded stock-based compensation expense of $90,721 and $254,331 during the three months ended June 30, 2025 and 2024, respectively. As of June 30, 2025 and December 31, 2024, there was $1,152,647 and $343,612, respectively, of unrecognized compensation cost related to nonvested share-based compensation arrangements granted under the 2021 Plan, which is expected to be recognized over the next one to four years.

A summary of option activity under the 2021 Plan during the six-month periods ended June 30, 2025 and 2024 is as follows:

Summary of Option Activity

						Weighted-Average		Aggregate
				Weighted-Average		Remaining Contractual		Intrinsic
	Shares			Exercise Price		Term (years)		Value
Outstanding at January 1, 2024		4,821
Granted		15,994		$	14.15		9.93		-
Exercised		-
Forfeitures or expirations		(628	)
Outstanding at March 31, 2024		20,187
Granted		69,038			13.44		9.95
Exercised		-
Forfeitures or expirations		-
Outstanding at June 30, 2024		89,225

Vested and expected to vest at June 30, 2024		89,225
Exercisable at June 30, 2024		2,643

Outstanding at January 1, 2025		89,406
Granted		248,428		$	4.44		9.87		-
Exercised		-
Forfeitures or expirations		-
Outstanding at March 31, 2025		337,834
Granted		61,005			4.14		9.98
Exercised		-
Forfeitures or expirations		-
Outstanding at June 30, 2025		398,839

Vested and expected to vest at June 30, 2025		398,839
Exercisable at June 30, 2025		131,986

The Company’s stock options issued qualify for equity accounting treatment under ASC 718, Compensation- Stock Compensation, and are measured at fair value as of their grant date accordingly. The fair value of the options were estimated using a Black-Scholes model. The assumptions that the Company used to estimate the grant-date fair value of stock options granted to employees and directors during the six-month periods ending June 30, 2025 and 2024 were as follows, shown on a weighted average basis:

Schedule of Fair Value Assumption

	June 30,			June 30,
	2025			2024
Risk-free interest rate		4.35	%		4.32	%
Expected term (in years)		5.73			5.42
Expected volatility		1.58			1.44
Expected dividend yield		0	%		0	%

Risk-Free Interest Rate: The Company based the risk-free interest rate over the expected term of the options based on the constant maturity of U.S. Treasury securities with similar maturities as of the date of grant.

Expected Term: The expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting dates and the end of the contractual term.)

Expected Volatility: The Company uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding volatility of its own stock price becomes available.

Expected Dividend Yield: The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero.

The grant-date fair value of options granted during the three months ended June 30, 2025 ranged from $3.56 to $3.73 and the grant-date fair value of options granted during the six months ended June 30, 2025 ranged from $3.56 to $4.22.

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock. Because there were no stock options with exercise prices lower than the fair value of the Company’s common stock, the aggregate intrinsic value is zero as of June 30, 2025 and December 31, 2024.

(11) Common Stock Purchase Warrants

The following table summarizes the Company’s outstanding common stock purchase warrants as of June 30, 2025:

					Issuance Date		Issuance Date
	Number of		Exercise		Fair Value		Fair Value
	Warrants		Price		per Warrant		Total
December 2021 Initial Public Offering Warrants		19,965	$	1,440.00	$	1,144.80	$	22,855,932
December 2021 Placement Agent Warrants		868	$	1,800.00	$	1,113.48		966,501
September 2023 Public Offering Series A Warrants		28,855	$	13.56	$	129.84		3,746,533
September 2023 Public Offering Series B Warrants		14,428	$	13.56	$	101.04		1,457,805
September 2023 Placement Agent Warrants		1,443	$	172.80	$	127.56		184,069
February 2024 Public Offering Series A Warrants		135,417	$	24.00	$	14.04		1,901,255
February 2024 Public Offering Series B Warrants		67,708	$	24.00	$	11.88		804,371
February 2024 Placement Agent Warrants		12,500	$	30.00	$	13.80		172,500
June 2024 Series C Warrants		354,167	$	7.020	$	3.24		1,147,501
June 2024 Series D Warrants		177,083	$	7.020	$	2.40		424,999
July 2024 Placement Agent Warrants		21,250	$	8.780	$	2.23		47,388
Balance- June 30, 2025		833,684					$	33,708,854

(12) Income Taxes

Cingulate Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws and regulations. CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities for Cingulate Inc. No deferred income tax benefit or expense was recorded for the three-month periods ended June 30, 2025 and 2024 or the six-month periods ended June 30, 2025 and 2024, for federal or state income taxes.

Income tax expense differed from the expected expense computed by applying the U.S. Federal income tax rate as follows:

	Three Months Ended June 30, 2025			Three Months Ended June 30, 2024			Six Months Ended June 30, 2025			Six Months Ended June 30, 2024
Federal income tax benefit at statutory rate	$	(1,004,778	)	$	(709,986	)	$	(1,803,354	)	$	(1,298,252	)
State income tax benefit		(245,082	)		(191,142	)		(439,546	)		(346,052	)
Permanent differences		3,346			2,420			6,650			6,074
Change in valuation allowance		1,247,371			897,439			2,237,364			1,667,878
Other		(857	)		1,269			(1,114	)		(29,648	)
Total income tax expense	$	-		$	-		$	-		$	-

Evaluating the need for, and amount of, a valuation allowance for deferred tax assets often requires significant judgment and extensive analysis of all available evidence on a jurisdiction-by-jurisdiction basis. Such judgments require the Company to interpret existing tax law and other published guidance as applied to its circumstances. As part of this assessment, the Company considers both positive and negative evidence about its profitability and tax situation. A valuation allowance is provided if, based on available evidence, it is more likely than not that all or some portion of a deferred tax asset will not be realized. The Company determined that it was more likely than not that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items. The Company recorded a valuation allowance of its net deferred tax assets totaling $19,670,515 as of June 30, 2025 and $17,405,569 at December 31, 2024, the current year portion which was recorded as a component of income tax expense on the accompanying consolidated statements of operations and other comprehensive loss.

The Company files income tax returns in the U.S. federal and various state jurisdictions. The Companies are not subject to U.S. federal and state income tax examinations by tax authorities for years before 2018.

The Company follows the provisions of FASB ASC 740, Income Taxes, to evaluate uncertain tax positions. This topic prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of June 30, 2025 or December 31, 2024.

(13) Leases

In May 2025, the Company executed a lease agreement to renew the office space for its headquarters in Kansas City, Kansas. The lease has a 5five-year term that commenced on June 1, 2025 with total rent of $33,145 per month over the lease term. The operating lease right-of-use asset was $1,447,220, the current portion of the operating lease liability was $223,633 and the long-term portion of the lease liability was $1,223,587 as of June 30, 2025.

(14) Subsequent Events

Management evaluated events that occurred subsequent to June 30, 2025, through August 19, 2025, which is the date the interim financial statements were issued.

Subsequent to June 30, 2025, the Company entered into five separate agreements with Lender to exchange an aggregate of $1,225,000 in principal for 268,738 shares of common stock, thereby extinguishing that portion of the Promissory Note. See Note 7 for additional information regarding the Promissory Note.

On July 21, 2025, the Company entered into a new purchase agreement with Lincoln Park (2025 LP Purchase Agreement), pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the 2025 LP Purchase Agreement) from time to time and at the Company’s sole discretion over the 36-month term of the 2025 LP Purchase Agreement. Pursuant to the terms of the 2025 LP Purchase Agreement, on July 21, 2025, the Company issued 120,424 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of common stock under the 2025 LP Purchase Agreement. In August 2025, the Company sold 69,389 shares of common stock under the 2025 LP Purchase Agreement, for net proceeds of $349,998.

On July 31, 2025, the Company submitted the New Drug Application for CTx-1301 to the FDA.

Subsequent to June 30, 2025, the Company sold 64,682 shares of common stock under the ATM Agreement, for net proceeds of $340,253.

On August 7, 2025, the employment of Laurie A. Myers, the Company’s former Executive Vice President and Chief Operating Officer, terminated.

On August 14, 2025, the Board (i) placed Shane Schaffer, Chairman and Chief Executive Officer, on administrative leave pending the resolution of personal legal proceedings, (ii) appointed Jennifer Callahan, the Company’s current Chief Financial Officer, to serve as interim Chief Executive Officer, effective immediately and (iii) appointed John A. Roberts, a current member of the Board, to serve as Executive Chairman of the Board, effective immediately. Ms. Callahan will continue to serve as Chief Financial Officer while serving as interim Chief Executive Officer until further action by the Board. In his role as Executive Chairman, Mr. Roberts will among other services, provide operational support to the Company’s executive management team.

On July 4, 2025, the U.S. President signed into law the “One Big Beautiful Bill Act” (“OBBBA”). The OBBBA imposes various changes to U.S. federal income tax regulation, including restoring bonus depreciation, removing the requirement to capitalize and amortize domestic research and development expenditures, increasing interest deductibility and reducing certain international deductions. The OBBBA also included certain modifications to the Inflation Reduction Act of 2022, including extending the clean fuel production tax credit from 2027 through 2029. Effects of changes in tax laws, including retroactive changes, are recognized in the financial statements in the period that the changes are enacted. The Company is currently evaluating the potential impact of the OBBBA on its deferred tax balances and other changes required to its financial statements, which will be reflected in the third quarter 10-Q as the enactment date was after period end.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this report. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2024 (Form 10-K) and in this report, as well as disclosures in this report and our other reports filed with the SEC, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a biopharmaceutical company using our proprietary Precision Timed Release^TM (PTR^TM) 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 Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety, we are identifying and evaluating additional therapeutic areas where our PTR technology may be employed to develop future product candidates. Our PTR platform incorporates a proprietary Erosion Barrier Layer (EBL) designed to allow for the release of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets. We believe there remains a significant, unmet need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and a superior side effect profile to better serve the needs of patients throughout their entire active-day.

Since inception in 2012, our operations have focused on developing our product candidates, primarily CTx-1301, organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting clinical trials. We do not have any product candidates approved for sale and have not generated any revenue. We have funded our operations through public and private capital raised. Cumulative capital raised from these sources, including debt financing, was approximately $113.5 million as of June 30, 2025.

We have incurred significant losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Our net losses were $4.8 million and $3.2 million for the three months ended June 30, 2025 and 2024, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of June 30, 2025, we had an accumulated deficit of $117.1 million.

We expect to continue to incur significant expenses and operating losses in the near term, as we:

	●	seek regulatory approval for CTx-1301;

	●	continue research and development activities for our existing and new product candidates, primarily for CTx-1301;

	●	continue manufacturing activities, primarily relating to CTx-1301;

	●	advance commercialization efforts for CTx-1301; and

	●	operate as a public company.

We filed our NDA for CTx-1301 with the FDA on July 31, 2025 and believe our cash will satisfy our capital needs into late 2025 under our current business plan. To advance our commercialization efforts for CTx-1301 into early 2026, we will need to raise approximately $1.5 million of additional capital. We will also need additional capital to advance our other programs. See “Liquidity and Capital Resources” below.

Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.

Management Update

On August 7, 2025, the employment of Laurie A. Myers, our former Executive Vice President and Chief Operating Officer, terminated.

On August 9, 2025, Shane Schaffer, Chairman and Chief Executive Officer, was charged with one count of aggravated domestic battery. On August 14, 2025, the Board (i) placed Shane Schaffer on administrative leave pending the resolution of the legal proceedings, (ii) appointed Jennifer Callahan, our current Chief Financial Officer, to serve as interim Chief Executive Officer, effective immediately and (iii) appointed John A. Roberts, a current member of the Board, to serve as Executive Chairman of the Board, effective immediately. Ms. Callahan will continue to serve as Chief Financial Officer while serving as interim Chief Executive Officer until further action by the Board. In his role as Executive Chairman, Mr. Roberts will among other services, provide operational support to our executive management team.

Clinical, Manufacturing and Business Update

CTx-1301: We designed our clinical program for CTx-1301 (dexmethylphenidate), our lead, investigational product candidate for the treatment of ADHD, based on U.S. Food and Drug Administration (FDA) feedback regarding our CTx-1301 clinical plan, and longstanding guidance on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

In order to meet the pharmacology requirement for the CTx-1301 NDA submission, we completed a food effect study in October 2022 (25mg dose) and December 2024 (50mg dose). Each study demonstrated that CTx-1301 can be taken with or without food.

We initiated two CTx-1301 Phase 3 clinical studies in pediatric and adolescent patients- a fixed dose study and a dose-optimized onset and duration study in a laboratory classroom setting in the third quarter of 2023. Based upon written communication with the FDA that further conduct of these pediatric and adolescent studies is not required for the submission of an NDA, we closed enrollment on both Phase 3 trials. Analysis of the safety data from the two closed Phase 3 trials and the 50mg dose food effect study revealed that no subjects experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death and there were no clinically relevant trends in TEAEs overall. A final analysis that combines both adult and pediatric safety and efficacy data was included in the NDA submission for CTx-1301.

On July 29, 2025, we received a PDUFA (Prescription Drug User Fee Act) fee waiver from the FDA for our NDA for CTx-1301. On July 31, 2025, we submitted the NDA for CTx-1301 to the FDA.

CTx-2103: We have embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, the most common mental health disorder in the United States. We completed a formulation study in which the pharmacokinetics were evaluated for this trimodal tablet providing three precisely timed doses of buspirone versus one immediate release dose. In addition, scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. Based on the pharmacokinetic profile seen in the data, CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to allow us to request a Pre-IND meeting with the FDA to discuss the design of our clinical and regulatory program for CTx-2103 which occurred in the fourth quarter of 2023. We received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing of an IND. Based on this FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway. Additional capital resources will be required to continue the development of this product candidate.

CTx-1302: We plan to initiate the clinical plan for CTx-1302 (dextroamphetamine), our second investigational asset for the treatment of ADHD, pending additional capital resources.

SEC Form 10-Q filed by Cingulate Inc.