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 March 31, 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 one share 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 May 7, 2025, 4,245,713 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.

Cingulate Inc.

Form 10-Q for the Quarter Ended March 31, 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	17
Item 3	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4	Controls and Procedures	27

	PART II
Item 1	Legal Proceedings	27
Item 1A	Risk Factors	27
Item 5	Other Information	28
Item 6	Exhibits	28

Signatures		29

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-1301, 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)

	March 31,			December 31,
	2025			2024
ASSETS

Current assets:
Cash and cash equivalents	$	9,518,966		$	12,211,321
Other receivables		41,573			26,325
Prepaid expenses and other current assets		944,433			423,157
Total current assets		10,504,972			12,660,803

Property and equipment, net		1,939,384			2,104,675
Operating lease right-of-use assets		25,232			99,011

Total assets		12,469,588			14,864,489

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Accounts payable		855,150			1,270,280
Accrued expenses		601,840			1,039,625
Note payable, current		4,124,935			2,527,108
Finance lease liability, current		-			4,430
Operating lease liability, current		33,145			130,662
Total current liabilities		5,615,070			4,972,105

Long-term liabilities:
Note payable		923,698			2,436,879
Total long-term liabilities		923,698			2,436,879

Total liabilities		6,538,768			7,408,984

Stockholders’ Equity
Common Stock, $0.0001 par value; 240,000,000 shares authorized and 3,826,199 and 3,402,306 shares issued and outstanding as of March 31, 2025 and December 31, 2024		382			340
Preferred Stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024		-			-
Additional Paid-in-Capital		118,222,309			115,944,345
Accumulated deficit		(112,291,871	)		(108,489,180	)
Total stockholders’ equity		5,930,820			7,455,505

Total liabilities and stockholders’ equity	$	12,469,588		$	14,864,489

See notes to consolidated financial statements.

Cingulate Inc.

Consolidated Statements of Operations and Comprehensive Loss (unaudited)

	2025			2024
	Three Months Ended March 31,
	2025			2024
Operating expenses:
Research and development	$	2,222,626		$	1,806,985
General and administrative		1,483,409			1,141,232
Operating loss		(3,706,035	)		(2,948,217	)

Interest and other income (expense), net		(96,656	)		(24,260	)
Loss before income taxes		(3,802,691	)		(2,972,477	)
Income tax benefit (expense)		-			-

Net loss and comprehensive loss	$	(3,802,691	)	$	(2,972,477	)

Net loss per share of common stock, basic and diluted	$	(1.04	)	$	(7.21	)

Weighted average number of shares used in computing net loss per share of common stock, basic and diluted		3,646,893			412,126

See notes to consolidated financial statements.

Cingulate Inc.

Consolidated Statements of Stockholders’ Equity (unaudited)

										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

Balance January 1, 2025		3,402,306	$	340	$	115,944,345	$	(108,489,180	)	$	-	$	7,455,505
Balance		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

See notes to consolidated financial statements

Cingulate Inc.

Consolidated Statements of Cash Flows (unaudited)

	2025			2024
	Three Months Ended March 31,
	2025			2024
Operating activities:
Net loss	$	(3,802,691	)	$	(2,972,477	)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation		165,291			163,600
Stock-based compensation		357,649			164,575
Accretion of discount on note payable		7,670			-
Amortization of debt issue costs		76,976			-
Changes in operating assets and liabilities:
Other receivables		(15,248	)		12,375
Prepaid expenses and other current assets		(521,276	)		(1,099,209	)
Operating lease right-of-use assets		73,779			63,078
Trade accounts payable and accrued expenses		(852,914	)		(4,995,037	)
Current portion of operating lease liability		(97,518	)		14,253
Long-term portion of operating lease liability		-			(97,518	)
Net cash used in operating activities		(4,608,282	)		(8,746,360	)

Investing activities:
Purchase of property and equipment		-			(81,508	)
Net cash used in investing activities		-			(81,508	)

Financing activities:
Proceeds from the issuance of common stock and pre-funded common stock purchase warrants, net of fees		1,920,357			9,893,450
Principal payments on finance lease obligations		(4,430	)		(4,167	)
Net cash provided by financing activities		1,915,927			9,889,283

Cash and cash equivalents:
Net increase (decrease) in cash and cash equivalents		(2,692,355	)		1,061,415
Cash and cash equivalents at beginning of year		12,211,321			52,415
Cash and cash equivalents at end of period	$	9,518,966		$	1,113,830

Cash payments:
Interest paid	$	45		$	308

See notes to 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 March 31, 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 March 31, 2025, the Company had cash and cash equivalents of approximately $9.5 million, and an accumulated deficit of approximately $112.3 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 March 31, 2025 and December 31, 2024, the consolidated statements of operations and comprehensive loss for the three-month periods ended March 31, 2025 and 2024, the consolidated statements of stockholders’ equity for the three-month periods ended March 31, 2025 and 2024, the consolidated statements of cash flows for the three-month periods ended March 31, 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 three-month periods ended March 31, 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 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:

Clinical operations	$	2025		$	2024
	Three Months Ended March 31,
	2025			2024
Operating expenses:
Research and development
Clinical operations	$	1,107,474		$	1,077,190
Drug manufacturing and formulation		380,353			341,199
Personnel		561,334			305,952
Regulatory		173,465			82,644
Total research and development		2,222,626			1,806,985
General and administrative
Personnel		571,530			413,277
Legal and professional fees		505,500			315,685
Occupancy		61,627			100,687
Insurance		195,596			241,524
Other		149,156			70,059
Total general and administrative		1,483,409			1,141,232
Operating loss		(3,706,035	)		(2,948,217	)
Interest and other income (expense), net		(96,656	)		(24,260	)
Loss before income taxes		(3,802,691	)		(2,972,477	)
Income tax benefit (expense)		-			-

Net loss and comprehensive loss	$	(3,802,691	)	$	(2,972,477	)

(3) Prepaid Expenses and Other Current Assets

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

	March 31,		December 31,
	2025		2024
Research and development	$	409,211	$	334,692
Professional fees		298,376		-
Marketing fees		125,000		-
Dues and subscriptions		39,750		4,575
Active pharmaceutical ingredients		29,025		29,025
Insurance		22,371		-
Other		20,700		54,865
	$	944,433	$	423,157

(4) Property and Equipment

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

Schedule of Property and Equipment

	Estimated
	Useful Life	March 31,			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	-		375,278			375,278
Property and equipment, gross			5,400,749			5,400,749
Less: accumulated depreciation			(3,461,365	)		(3,296,074	)
Property and equipment, net		$	1,939,384		$	2,104,675

Depreciation expense was $165,291 and $163,600, respectively, for the three-month periods ended March 31, 2025 and 2024.

(5) Accrued Expenses

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

Schedule of Accrued Expenses

	March 31,		December 31,
	2025		2024
Research and development	$	338,007	$	341,956
Interest		140,114		15,089
State franchise taxes		34,750		200,000
CIP- Equipment		31,160		31,160
Other		22,809		56,476
Employee compensation		20,000		355,475
Professional fees		15,000		5,000
Insurance		-		34,469
Total accrued expenses	$	601,840	$	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 March 31, 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 March 31, 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. In the event the Promissory Note is outstanding on the 90-day anniversary of the effective date of the Promissory Note, the Company will be charged and record 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 March 31, 2025, the collective amount of unamortized debt discount and debt issuance costs were $431,366, respectively.

As of March 31, 2025, the outstanding principal balance of the Promissory Note plus accrued interest was $5,620,114.

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

Schedule of Interest Expense (Income)

	2025			2024
	Three Months Ended March 31,
	2025			2024
Interest expense - Streeterville Capital	$	209,671		$	-
Interest expense - other		45			308
Interest expense - WFIA		-			31,250
Interest expense		-			31,250
Interest income		(112,932	)		(7,298	)
Total	$	96,784		$	24,260

(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 March 31, 2025 and December 31, 2024, of which 3,826,199 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 the 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 March 31, 2025 and 2024, the Company sold 200,484 and 23,650 shares of common stock, respectively, under the ATM Agreement, for net proceeds of $1,020,368 and $3,115,303.

Purchase Agreement with Lincoln Park

In April 2023, the Company entered into a purchase agreement (the 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 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 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 LP Purchase Agreement.

During the three months ended March 31, 2025, the Company sold 223,409 shares of common stock under the LP Purchase Agreement, for net proceeds of $899,989.

(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. As of March 31, 2025, 4,000 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 $357,649 and $164,575 during the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, there was $1,026,469 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 three-month periods ended March 31, 2025 and 2024 is as follows:

Summary of Option Activity

				Weighted-Average		Weighted-Average Remaining Contractual		Aggregate 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

Vested and expected to vest at March 31, 2024		20,187
Exercisable at March 31, 2024		1,945

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

Vested and expected to vest at March 31, 2025		337,834
Exercisable at March 31, 2025		124,069

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 three-month periods ending March 31, 2025 and 2024 were as follows, shown on a weighted average basis:

Schedule of Fair Value Assumption

	March 31,			March 31,
	2025			2024
Risk-free interest rate		4.43	%		3.980	%
Expected term (in years)		5.79			5.55
Expected volatility		1.63			1.56
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 March 31, 2025 ranged from $4.20 to $4.22 and the grant-date fair value of options granted during the three months ended March 31, 2024 ranged from $0.81 to $1.53.

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 March 31, 2025 and December 31, 2024.

(11) Common Stock Purchase Warrants

The following table summarizes the Company’s outstanding common stock purchase warrants as of March 31, 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- March 31, 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 March 31, 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 March 31, 2025			Three Months Ended March 31, 2024
Federal income tax benefit at statutory rate	$	(798,576	)	$	(588,266	)
State income tax benefit		(194,464	)		(154,910	)
Permanent differences		3,304			3,654
Change in valuation allowance		989,993			770,439
Other		(257	)		(30,917	)
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 $18,423,145 as of March 31, 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 March 31, 2025 or December 31, 2024.

(13) Subsequent Events

Management evaluated events that occurred subsequent to March 31, 2025, through May 8, 2025, which is the date the interim financial statements were issued.

On April 8, 2025, the Company entered into a Grant Agreement (the “Grant Agreement”) with a private family foundation (the “Foundation”). Pursuant to the Grant 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 is expected to be received in May 2025, the second payment is expected to be received upon completion of a formulation study for CTX-2103, and the third payment is expected to be received 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 the 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.

Subsequent to March 31, 2025, the Company sold 205,826 shares of common stock under the ATM Agreement, for net proceeds of $868,520.

Subsequent to March 31, 2025, the Company sold 197,104 shares of common stock under the Lincoln Park Purchase Agreement, for net proceeds of $749,991.

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 $109.3 million as of March 31, 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 $3.8 million and $3.0 million for the three months ended March 31, 2025 and 2024, respectively. See “Results of Operations” below for an explanation of the fluctuations in our net losses. As of March 31, 2025, we had an accumulated deficit of $112.3 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;

	●	seek licensing partners and/or outsource commercial infrastructure to support sales and marketing for CTx-1301; and

	●	operate as a public company.

We are targeting to file our NDA submission for CTx-1301 in mid-2025 and believe our cash will satisfy our capital needs into the fourth quarter of 2025 under our current business plan. We will need additional capital to advance our other programs and commercialization efforts for CTx-1301. 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.

Clinical, Manufacturing and Business Update

CTx-1301: We have 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. We are performing the data consolidation and analytical activities for these 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 will be included in the NDA submission for CTx-1301.

On April 2, 2025, we held a Pre-NDA meeting with FDA to discuss the NDA submission for CTx-1301, targeted for a mid-2025.

CTx-2103: We have embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, which is one of the most common mental health concerns 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 resources will be required to complete the development of this product candidate.

On April 8, 2025, we entered into a Grant Agreement (the “Grant Agreement”) with a private family foundation (the “Foundation”). Pursuant to the Grant Agreement, we received a grant of $3 million in three equal installments of $1 million (the “Grant Funds”) to support the clinical and manufacturing development of CTx-2103 (the “Purpose). The first installment is expected to be received in May 2025, the second installment is expected to be received upon completion of a formulation study for CTX-2103, and the third installment is expected to be received upon completion of development batches required for CTx-2103. We are not required to return any Grant Funds received from the Foundation unless the Purpose has ended, in which case we will return any remaining Grant Funds to the Foundation. We 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.

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.

We continue to evaluate strategic partnerships under which we would license CTx-1301 in the United States and/or internationally. In March 2023, we entered into a joint commercialization agreement, which was replaced with a master services agreement in May 2025 with Indegene, Inc. (Indegene) in the United States . We are able to utilize Indegene for commercialization services for CTx-1301, including marketing, sales, market access and distribution, on a fee for service, at our discretion.

Securities Issuances

ATM Agreement

We entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC (HCW), as sales agent, in January 2023 as amended in May 2023, pursuant to which we may offer and sell, from time to time through HCW, shares of our common stock for aggregate proceeds of up to $23.5 million based on prospectus supplements filed with the SEC through the date of this report (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement). In the three months ended March 31, 2025, we sold 200,484 shares of common stock under the ATM Agreement, for net proceeds of $1,020,368, after deducting $33,754 of compensation to HCW and other administration fees. Subsequent to March 31, 2025, we sold 205,826 shares of common stock under the ATM Agreement, for net proceeds of $868,520, after deducting $30,617 of compensation to HCW and other administration fees.

Equity Line of Credit

In April 2023, we entered into a purchase agreement (Lincoln Park Agreement) with Lincoln Park Capital Fund LLC (Lincoln Park). Pursuant to the Lincoln Park Agreement, Lincoln Park has agreed to purchase from us up to an aggregate of $12.0 million of common stock (upon the terms and subject to the conditions and limitations set forth in the Lincoln Park Agreement) from time to time and at our sole discretion over the 36-month term of the Lincoln Park Agreement. During the quarter ended March 31, 2025, we sold 223,409 shares of common stock under the Lincoln Park Agreement, for net proceeds of $899,989. Subsequent to March 31, 2025, we sold 197,104 shares of common stock under the Lincoln Park Purchase Agreement, for net proceeds of $749,991.

Components of Operating Results

Revenue

Since inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the near future. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration of license agreements.

Operating Expenses

Research and Development Expenses

Research and development expenses consist of costs incurred in the discovery and development of our product candidates, and primarily include:

	●	expenses incurred under third party agreements with contract research organizations (CROs), and investigative sites, that conducted or will conduct our clinical trials and a portion of our pre-clinical activities;

	●	costs of raw materials, as well as manufacturing cost of our materials used in clinical trials and other development testing;

	●	expenses, including salaries and benefits of employees engaged in research and development activities;

	●	costs of manufacturing equipment, depreciation and other allocated expenses; and

	●	fees paid for contracted regulatory services as well as fees paid to regulatory authorities including the FDA for review and approval of our product candidates.

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued costs.

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue clinical development for our product candidates, as well as adding additional PTR product candidates to our pipeline. As products enter later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related to the development of CTx-1301. As we advance CTx-1301, CTx-1302, and CTx-2103, as well as identify any other potential product candidates, we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs for our employees in administrative, executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, audit, tax and consulting services, insurance, office, and travel expenses.

We expect that our general and administrative expenses will increase in the future as we increase our general and administrative headcount to support our growing operations including the potential commercialization of our product candidates. We have experienced, and will continue to experience, increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance services; director and officer insurance; and investor and public relations costs.

Interest and other income (expense), net

Interest and other income (expense), net consisted of interest expense on our related party notes payable until the last of those obligations were converted to equity in the first quarter of 2024, and interest expense on the promissory note executed in December of 2024, offset by interest earned on our cash and cash equivalents, including money market funds. The primary objective of our investment policy is liquidity and capital preservation.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during a reporting period. Actual results could differ from estimates.

A discussion of these policies can be found in the “Critical Accounting Policies and Significant Judgments and Estimates” section of our Form 10-K. There have been no changes in our application of critical accounting policies since December 31, 2024.

Results of Operations

Comparison of the three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:

	Three Months Ended
	March 31,								%
(in thousands)	2025			2024			Increase		Increase
Operating Expenses:
Research and development	$	2,223		$	1,807		$	416		23.0	%
General and administrative		1,483			1,141			342		30.0	%
Operating Loss		(3,706	)		(2,948	)		758		25.7	%
Interest and other income (expense), net		(97	)		(24	)		73		304.2	%
Net Loss	$	(3,803	)	$	(2,972	)	$	831		28.0	%

Research and development expenses

The following table summarizes our research and development (R&D) expenses for the three months ended March 31, 2025 and 2024:

	Three Months Ended
	March 31,						%
(in thousands)	2025		2024		Increase		Increase
Clinical operations	$	1,108	$	1,077	$	31		2.9	%
Drug manufacturing and formulation		380		341		39		11.4	%
Personnel expenses		561		306		255		83.3	%
Regulatory costs		174		83		91		109.6	%
Total research and development expenses	$	2,223	$	1,807	$	416		23.0	%

R&D expenses were $2.2 million for the three months ended March 31, 2025, an increase of $0.4 million or 23.0% from the three months ended March 31, 2024. This change was primarily the result of an increase in personnel expenses and regulatory costs in the three months ended March 31, 2025 as compared to the same period in 2024. The increase in personnel costs is the result of the reinstatement of base salaries in September 2024 following salary reduction measures which had been implemented in late 2023. Regulatory costs increased in the three months ended March 31, 2025 as compared to the same period in 2024 due to preparation for the pre-NDA meeting with the FDA.

General and administrative expenses

The following table summarizes our general and administrative (G&A) expenses for the three months ended March 31, 2025 and 2024:

	Three Months Ended							%
	March 31,				Increase			Increase
(in thousands)	2025		2024		(Decrease)			(Decrease)
Personnel expenses	$	571	$	413	$	158			38.3	%
Legal and professional fees		505		316		189			59.8	%
Occupancy		62		101		(39	)		(38.6	%)
Insurance		196		241		(45	)		(18.7	%)
Other		149		70		79			112.9	%
Total general and administrative expenses	$	1,483	$	1,141	$	342			30.0	%

Total G&A expenses were $1.5 million for the three months ended March 31, 2025, an increase of $0.3 million or 30.0% from the three months ended March 31, 2024. This is primarily the result of an increase in legal and professional fees and personnel expenses. The increase in professional fees was due to an increase in certain financial, accounting and investor relations fees. The increase in personnel costs is the result of reinstatement of base salaries in September 2024 following salary reduction measures which had been implemented in late 2023.

Interest and other income (expense), net

The following table summarizes interest and other income (expense), net for the three months ended March 31, 2025 and 2024:

	Three Months Ended
	March 31,								%
(in thousands)	2025			2024			Increase		Increase
Interest and other income (expense), net	$	(97	)	$	(24	)	$	73		304.2	%

Total interest and other income (expense), net for the three months ended March 31, 2025 and March 31, 2024 relates to interest incurred on outstanding notes payable, offset by interest earned on invested balances. The increase in interest expense for the period ended March 31, 2025 is related to interest expense incurred on the $5.4 million promissory note which was executed in December 2024.

Cash Flows

	Three Months Ended
	March 31,
	2025			2024
Net cash (used in) operating activities	$	(4,608	)	$	(8,746	)
Net cash (used in) investing activities		-			(82	)
Net cash (used in) financing activities		1,916			9,889
Net increase (decrease) in cash and cash equivalents	$	(2,692	)	$	1,061

Cash Flows from Operating Activities

Net cash used in operating activities was $4.6 million for the three months ended March 31, 2025. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $3.8 million, prior to the effects of two noncash items, stock-based compensation expense of $0.4 million and depreciation expense of $0.2 million. Changes in operating assets and liabilities included a decrease in trade accounts payable and accrued expenses of $0.9 million primarily due to the payment of vendor balances in the first quarter of 2025 and an increase in prepaid expenses and other current assets of $0.5 million primarily due to payments for professional and marketing fees.

Net cash used in operating activities was $8.7 million for the three months ended March 31, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $3.0 million, prior to the effects of two noncash items, stock-based compensation expense of $0.2 million and depreciation expense of $0.2 million. Changes in operating assets and liabilities included an increase in prepaid expenses and other current assets of $1.1 million primarily due to a deposit made to Societal CDMO, Inc., our contract manufacturing organization (CMO), for registration batch activity for CTx-1301. In addition, there was a decrease in trade accounts payable and accrued expenses of $5.0 million due to the payment of vendor balances with the cash proceeds from the issuance of common stock pursuant to our ATM Agreement in January 2024 and the issuance of equity in February 2024.

Cash Flows from Investing Activities

Net cash used in investing activities for the three months ended March 31, 2024 was primarily related to the purchase of equipment to support our research and development.

Cash Flows from Financing Activities

Net cash provided by financing activities for the three-month period ended March 31, 2025 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement and the Lincoln Park Agreement.

Net cash provided by financing activities for the three months ended March 31, 2024 was related to the cash proceeds from the issuance of common stock pursuant to the ATM Agreement in January 2024 and the issuance of common stock in February 2024.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception in 2012 through March 31, 2025, we have not generated any revenue and have incurred significant operating losses and negative cash flow from our operations.

In the three months ended March 31, 2025, we sold 200,484 shares of common stock under the ATM Agreement, for net proceeds of $1,020,368, after deducting $33,754 of compensation to HCW and other administration fees. Subsequent to March 31, 2025, we sold 205,826 shares of common stock under the ATM Agreement, for net proceeds of $868,520, after deducting $30,617 of compensation to HCW and other administration fees.

During the three months ended March 31, 2025, we sold 223,409 shares of common stock under the Lincoln Park Purchase Agreement, for net proceeds of $899,989. Subsequent to March 31, 2025, we sold 197,104 shares of common stock under the Lincoln Park Purchase Agreement, for net proceeds of $749,991.

As of March 31, 2025, we had cash and cash equivalents of $9.5 million. We believe our cash will satisfy our capital needs into the fourth quarter of 2025 under our current business plan, which is beyond the targeted date to file our NDA submission for CTx-1301 of mid-2025. We will need additional capital to advance our commercialization efforts for CTx-1301 as well as our other programs. Changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control. Our policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide liquidity while producing a modest return on investment. Accordingly, our cash equivalents are invested primarily in money market funds which are currently providing only a minimal return given the current interest rate environment.

We expect to continue to incur substantial additional operating losses for the near term as we continue to develop our product candidates, primarily CTx-1301 and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate governance, internal controls and similar requirements applicable to us as a public company.

Our future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:

	●	the cost and timing of manufacturing the clinical supply of our product candidates;

	●	the initiation, progress, timing, costs and results of clinical trials for our product candidates;

	●	the clinical development plans we establish for each product candidate;

	●	the number and characteristics of product candidates that we develop or may in-license;

	●	the terms of any collaboration or license agreements we may choose to execute;

	●	the outcome, timing and cost of meeting regulatory requirements established by the FDA or other comparable foreign regulatory authorities;

	●	the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

	●	the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us;

	●	the cost and timing of the implementation of commercial scale manufacturing activities; and

	●	the cost and timing of outsourcing our commercialization efforts, including, sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products.

To continue to grow our business over the longer term, we plan to commit substantial resources to research and development, including clinical trials of our product candidates, and other operations and potential product acquisitions and in-licensing. We have evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in-license and develop additional products and product candidates to augment our internal development pipeline. Strategic transaction opportunities that we may pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. In addition, we may pursue development, acquisition or in-licensing of approved or development products in new or existing therapeutic areas or continue the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to license or acquire additional products, product candidates or companies to expand our operations, or for general corporate purposes. Strategic transactions may require us to raise additional capital through one or more public or private debt or equity financings or could be structured as a collaboration or licensing arrangement. We are actively seeking a strategic pharmaceutical partnership under which we would license CTx-1301 in the United States, internationally, or both. In March 2023, we entered into a joint commercialization agreement, which was replaced with a master services agreement in May 2025, with Indegene. Should we be unable to identify an appropriate pharmaceutical partnership, if we receive FDA approval for CTx-1301, Indegene would provide commercialization services for CTx-1301, including marketing, sales, market access and distribution, on a fee for service basis.

If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

For example, pursuant to the Note Purchase Agreement, we are subject to certain restrictions on our ability to issue securities during the term of the Note. Specifically, we have agreed, among other things, to obtain Lender’s consent prior to issuing any debt securities or certain equity securities where the pricing of such equity securities is tied to the public trading price of our common stock and to refrain from entering into any agreement or covenant that locks up, restricts or otherwise prohibits us from entering into a variable rate transaction with Lender or any of its affiliates, or from issuing common stock or other equity or debt securities to Lender or any of its affiliates. If we are unable to obtain Lender’s consent prior to issuing any debt or certain equity securities, such issuance may be a breach of the Note Purchase Agreement, and we may be obligated to indemnify Lender for loss or damage arising as a result of any breach or alleged breach by us of the Note Purchase Agreement, which may affect our business operations and financial condition. Additionally, the Note provides that following an event of default under the Note, Lender has the right to seek and receive injunctive relief from a court or an arbitrator prohibiting us from issuing any of our common stock or preferred stock to any party unless fifty percent of the gross proceeds received by us in connection with such issuance are simultaneously used to make a payment under the Note. Lender also has the right to seek and receive injunctive relief from a court or arbitrator to prevent the consummation of any fundamental transaction, as defined in the Note, unless it contains a closing condition that the Note is paid in full upon consummation of the transaction or Lender has provided its written consent to such transaction.

Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences that are not favorable to us or our existing stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. 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.

Contractual Obligations

The following summarizes our contractual obligations as of March 31, 2025 that will affect our future liquidity.

We entered into a patent and know-how licensing agreement with BDD Pharma Limited in August 2018. See “Item 1. Business – Material Agreements” section of our Form 10-K for a description of this agreement. We are required to pay BDD Pharma certain amounts in connection with clinical trial and regulatory milestones. The first milestone payment of $250,000 was paid in February 2023 upon dosing of the first patient in the Phase 3 adult onset and duration study for CTx-1301. Additional payments will become due upon completion of certain milestones as defined in the agreement.

We entered into agreements with Societal, our CMO, for both the manufacturing of pre-process validation batches of our lead asset, CTx-1301 and active pharmaceutical ingredients and materials to be used in process validation batches with a total estimated cost of approximately $1.8 million.

Going Concern

Since inception we have been engaged in organizational activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological change that is largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for one year after the issuance date of our financial statements. The accompanying consolidated financial statements have been prepared on a going concern basis. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the company to continue as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. We have incurred a net loss for the three months ended March 31, 2025 and 2024 and had accumulated losses of $112.3 million since inception to March 31, 2025. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development. Our sources of capital have included private capital raises in various classes of units of CTx prior to the Reorganization Merger, the issuance of equity securities in connection with our initial public offering (IPO), public offerings, including the September 2023 Offering and the February 2024 Offering, sales of common stock under our ATM Agreement and Lincoln Park Agreement, a private placement with WFIA, the WFIA Note, which was subsequently converted to equity, the June 2024 Warrant Inducement and the issuance of the Promissory Note in December 2024. Additional capital will be needed by us to fund our operations, to complete development of and to commercially develop our product candidates. There is no assurance that such capital will be available when needed or on acceptable terms.

JOBS Act

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (JOBS Act) was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an “emerging growth company,” we are electing to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards, and as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for emerging growth companies.

Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation. These exemptions will apply until the fifth anniversary of the completion of our IPO or until we no longer meet the requirements for being an “emerging growth company,” whichever occurs first.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures.

Evaluation of Our Disclosure Controls

We maintain a system of disclosure controls and procedures that is designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized and reported within time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to the our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Our Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of March 31, 2025, have concluded that our disclosure controls and procedures were effective as of March 31, 2025.

Evaluation of Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

Item 1. Legal Proceedings.

See Part I, Item 1, Notes to Consolidated Financial Statements, Note 6 – Contingencies, of this report.

Item 1A. Risk Factors.

Our business is subject to substantial risks and uncertainties. Investing in our securities involves a high degree of risk. You should carefully consider the risk factors in Part I, Item 1A of our Form 10-K, together with the information contained elsewhere in this report, including Part I, Item 1 “Financial Statements” and Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other SEC filings in evaluating our business. These risks and uncertainties could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our securities.

Except as set forth below, there were no material changes to the risk factors previously disclosed in our Form 10-K.

Item 5. Other Information

Rule 10b5-1 Trading Arrangements

In the first quarter of 2025, no director or officer (as defined in Exchange Act Rule 16a-1(f)) of the Company adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement for the purchase or sale of securities of the Company, within the meaning of Item 408 of Regulation S-K.

Agreement with Indegene, Inc.

On March 7, 2023, we entered into a Joint Commercialization Agreement (the “Commercialization Agreement”) with Indegene, Inc. (“Indegene”). On May 7, 2025, the Commercialization Agreement was terminated and we and Indegene entered into a Master Services Agreement (the “Indegene MSA”).

Like the Commercialization Agreement prior to its termination, the Indegene MSA governs the general terms under which Indegene will provide commercialization services, upon our request. Pursuant to the Indegene MSA, the parties will enter into statements of work that will set forth, among other things, the services to be performed by Indegene, the deliverables for such services, and the fees to be paid by us. Each statement of work will be governed by the terms of the Indegene MSA unless expressly modified in such statement of work. We may elect to receive the following services from Indegene: (a) medical affairs & pharmacovigilance; (b) pricing, reimbursement and market access; (c) commercial operations; and (d) marketing (including field force).

In the event that we intend to outsource any services within the scope of services that Indegene has the capability to perform, we shall allow Indegene to participate in our request for proposals; provided, that we may, in our sole discretion, select the party that will provide such services.

Indegene personnel will not be assigned to or interact with any other Indegene customer engaged in similar or competing projects within the same therapeutic area for which such personnel are providing services to us. This restriction does not restrict Indegene from offering similar or competing services to other customers through separate personnel, teams or affiliates; provided, that Indegene complies with the terms and conditions of the Indegene MSA, including the confidentiality provisions.

The Indegene MSA has a three-year term. The Indegene MSA may not be terminated for convenience during the initial twelve (12) months following the first commercial sale of CTx-1301 or eighteen (18) months from the effective date of the Indegene MSA, whichever is earlier. Thereafter, either party may terminate the Indegene MSA upon six (6) months prior written notice to the other party. Either party may terminate the Indegene MSA upon thirty (30) days prior, written notice for material, uncured breaches or immediately in the event of the other party’s bankruptcy.

The Indegene MSA contains representations, warranties, confidentiality and indemnity obligations customary for agreements of this type.

The description of the Indegene MSA does not purport to be complete and is qualified in its entirety by reference to the full text of the Indegene MSA, which has been filed as Exhibit 10.4 to this report and is incorporated herein by reference.

Item 6. Exhibits

		Incorporated by Reference
Exhibit Number	Exhibit Description	Form	Exhibit	Filing Date
3.1	Amended and Restated Certificate of Incorporation of Cingulate Inc., as amended to date	10-Q	3.1	8/13/2024
3.2	Amended and Restated Bylaws of Cingulate Inc.	10-K	3.2	3/28/2022
10.1	Amendment to Employment Agreement, effective January 1, 2025, between Cingulate Therapeutics LLC and Matthew N. Brams	8-K	10.1	1/24/2025
10.2	Amendment No. 1 to Master Services Agreement, effective February 12, 2025, between Cingulate Therapeutics LLC and Societal CDMO, Inc. (DBA Bend Biosciences)	10-K	10.3	3/27/2025
10.3	Grant Agreement dated April 8, 2025	8-K	10.1	4/9/2025
10.4*	Master Services Agreement, effective May 7, 2025, between Indegene, Inc. and Cingulate Therapeutics LLC
31.1*	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**	Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**	Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*	XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH*	Inline XBRL Taxonomy Extension Schema
101.CAL*	Inline XBRL Extension Calculation Linkbase
101.DEF*	Inline XBRL Taxonomy Extension Definition Linkbase
101.LAB*	Inline XBRL Taxonomy Extension Label Linkbase
101.PRE*	Inline XBRL Taxonomy Extension Presentation Linkbase
104*	Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

* Filed Herewith

** Furnished Herewith

SIGNATURES

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 thereunto duly authorized.

	CINGULATE INC.

Date: May 8, 2025	By:	/s/ Shane J. Schaffer
		Shane J. Schaffer
		Chairman and Chief Executive Officer
		(Principal Executive Officer)

Date: May 8, 2025	By:	/s/ Jennifer L. Callahan
		Jennifer L. Callahan
		Chief Financial Officer
		(Principal Financial Officer and Principal Accounting Officer)

SEC Form 10-Q filed by Cingulate Inc.