Cingulate Inc. Reports Third Quarter 2026 Financial Results and Provides Regulatory Update on CTx-1301 NDA Resubmission

Rhea-AI Summary

Cingulate (NASDAQ: CING) reported third-quarter results and substantially completed manufacturing work addressing FDA information requests for its CTx-1301 application. The company expects to resubmit the new drug application for the ADHD treatment between December 2026 and January 2027. Supporting data and documentation are being finalized. The FDA's June 1, 2026 Complete Response Letter requested additional chemistry, manufacturing and controls information but identified no clinical safety or efficacy concerns.

Third-quarter net loss widened to $7.7 million from $7.3 million a year earlier, while selling, general and administrative expenses rose 45.5%. Cash and cash equivalents reached approximately $23.2 million at September 30, versus $11.0 million at year-end 2025, following capital raises. Cingulate expects its cash to fund operations into mid-2027, including regulatory approval efforts and commercial readiness work.

15 points · 2 major

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

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1 major · 10 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointFinancing included a $12.0 million private placement closed in the first quarter of 2026. 19% of market cap
• Major pointCapital raised through AGP and Lincoln Park Capital agreements totaled $22.5 million during the first nine months of 2026. 36% of market cap
• Moderate pointCTx-1301 manufacturing work addressing FDA requests is substantially completed; supporting documentation is being finalized.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cingulate expects CTx-1301 application resubmission between December 2026 and January 2027.
• Moderate pointCash increased to $23,185,900 at September 30, 2026, from $10,953,383 at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cingulate expects cash to fund operations into mid-2027, including approval efforts and commercial readiness.
• Moderate pointNine-month research and development expenses decreased 15.3% to $6.6 million from $7.8 million a year earlier.

8 minor points

• Minor pointCTx-1301's FDA response letter identified no clinical safety or efficacy concerns.
• Minor pointWorking capital increased to $18,832,234 at September 30, 2026, from $1,695,633 at December 31, 2025.
• Minor pointTotal liabilities fell to $7,383,547 at September 30, 2026, from $12,564,356 at December 31, 2025.
• Minor pointTotal assets rose to $28,150,677 at September 30, 2026, from $15,073,263 at December 31, 2025.
• Minor pointStockholders' equity increased to $20,767,130 at September 30, 2026, from $2,508,907 at December 31, 2025.
• Minor pointThird-quarter derivative fair-value loss narrowed to $69,323 from $772,169 a year earlier.
• Minor pointThird-quarter net interest and other expense declined to $171,056 from $573,058 a year earlier.
• Minor pointCommercial readiness capabilities are being expanded, including headcount and activities through commercialization partner Indegene.

Negative

• Major pointCTx-1301 received an FDA Complete Response Letter on June 1, 2026, requesting additional manufacturing-related information.
• Moderate pointNine-month net loss widened to $22,913,750 from $16,177,001 a year earlier.
• Moderate pointNine-month selling, general and administrative expenses increased 116.6% to $14.2 million from $6.6 million a year earlier.
• Moderate pointOperating cash use totaled $20.4 million during the first nine months of 2026.
• Minor pointThird-quarter net loss widened to $7,731,397 from $7,341,062 a year earlier.

5 minor points

• Minor pointThird-quarter selling, general and administrative expenses increased 45.5% to $4.6 million from $3.1 million a year earlier.
• Minor pointThird-quarter research and development expenses rose 2.2% to $2.9 million, primarily reflecting higher manufacturing costs.
• Minor pointNine-month derivative fair-value loss increased to $1,235,366 from $1,016,682 a year earlier.
• Minor pointNine-month net interest and other expense increased to $849,169 from $808,475 a year earlier.
• Minor pointAccumulated deficit widened to $155,288,781 at September 30, 2026, from $132,375,031 at December 31, 2025.

News Explained

After it receives the resubmission, the FDA is expected to classify it as Class 1 or Class 2, with review goals of two or six months, respectively.

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Market Reaction – CING

$4.18 – $4.60 Day Range

$61.68M Mkt Cap at Last Price

On Nov 13, the day this news came out, the latest delayed price for CING is 1.35% below the previous close. Our momentum scanner has recorded 11 alerts for this stock so far that day. The latest delayed price is $4.24. Relative volume is above average at 1.6x what this stock usually trades by this time of day.

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Key Figures

Cash and cash equivalents: approximately $23.2 million Working capital: approximately $18.8 million Cash runway: into mid-2027 +5 more

Cash and cash equivalents

approximately $23.2 million

As of September 30, 2026

Working capital

approximately $18.8 million

As of September 30, 2026

Cash runway

into mid-2027

Under the company’s current business plan

Cash used for operations

$20.4 million

First nine months of 2026

Capital raised

$22.5 million

Through the At-the-Market Agreement and Purchase Agreement during the first nine months of 2026

Net loss

$22.9 million

Nine months ended September 30, 2026; compared with $16.2 million in 2025

NDA resubmission

Expected between December 2026 and January 2027

CTx-1301

FDA review goals

Two months for Class 1; six months for Class 2

Expected classification after FDA receives the resubmission

Previous Earnings Reports

1 past event · Latest: Aug 13

Same Type 1 event

1. Aug 13

   Q2 earnings

   24h Move

   -4.2%

   Reported $28.4M cash and mid-2027 runway while CMC work remained underway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cmc, nda, cdmo, complete response letter

4 terms

cmc regulatory

"chemistry, manufacturing and controls (CMC) information requests"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

nda regulatory

"resubmit the new drug application (NDA) for CTx-1301"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

cdmo technical

"its contract development and manufacturing organization (CDMO)"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

complete response letter regulatory

"the FDA issued a Complete Response Letter (CRL)"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Manufacturing Work Addressing FDA CMC Information Requests Substantially Completed

NDA Resubmission Expected Between December 2026 and January 2027

KANSAS CITY, Kan., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended September 30, 2026, and announced that it has substantially completed the manufacturing work required to address the U.S. Food and Drug Administration’s (FDA) chemistry, manufacturing and controls (CMC) information requests for CTx-1301. The Company expects to resubmit the new drug application (NDA) for CTx-1301 between December 2026 and January 2027.

“With the manufacturing work substantially complete, we are now finalizing the data and documentation needed to resubmit the NDA for CTx-1301, and we expect to do so by January 2027, potentially sooner,” stated Cingulate Chairman and CEO Shane J. Schaffer. “Importantly, the FDA’s Complete Response Letter did not raise any concerns about the clinical safety or efficacy of CTx-1301. We thank our shareholders for their patience and continued support as we work to bring this treatment to patients with ADHD.”

Regulatory Update: CTx-1301 NDA Resubmission Progress

On June 1, 2026, the FDA issued a Complete Response Letter (CRL) for the CTx-1301 (dexmethylphenidate HCl) NDA. The CRL identified specific requests for additional CMC information and did not identify any concerns regarding the clinical safety or efficacy of CTx-1301, the Company’s lead ADHD asset.

Since then, Cingulate and its contract development and manufacturing organization (CDMO), Bend Bioscience, have substantially completed the manufacturing work required to address the CMC requests in the CRL and are finalizing the supporting data and documentation for resubmission. As announced on November 9, 2026, the Company expects to resubmit the NDA between December 2026 and January 2027. After the FDA receives the resubmission, it is expected to classify it as a Class 1 or Class 2 resubmission, which carry review goals of two and six months, respectively.

Third Quarter Financial Results

Cash and Working Capital: As of September 30, 2026, Cingulate had approximately $23.2 million in cash and cash equivalents, compared to $11.0 million as of December 31, 2025. The increase was primarily driven by capital raised during the first nine months of 2026, including the close of a $12.0 million private placement in the first quarter and $22.5 million of capital raised on Cingulate’s At-the-Market Agreement with AGP and Purchase Agreement with Lincoln Park Capital, partially offset by $20.4 million in cash used for operations. As of September 30, 2026, Cingulate had approximately $18.8 million in working capital, an increase of $16.1 million as compared to December 31, 2025.

Under its current business plan, the Company believes its cash and cash equivalents will be sufficient to fund operations into mid-2027, including costs associated with seeking regulatory approval for CTx-1301, and continuing the build-out of commercial readiness capabilities.

R&D Expenses: Research and development expenses were $2.9 million for the three months ended September 30, 2026, an increase of 2.2% from $2.8 million for the three months ended September 30, 2025, driven primarily by higher drug manufacturing costs to address the CMC information requested in the FDA’s CRL, partially offset by lower clinical operations costs following the conclusion of clinical study activities in early 2025, the absence of regulatory costs incurred in the prior-year period in connection with preparing the CTx-1301 NDA, and lower personnel expenses. For the nine months ended September 30, 2026, R&D expenses were $6.6 million, a decrease of 15.3% from $7.8 million for the nine months ended September 30, 2025, driven primarily by lower clinical operations and regulatory costs, partially offset by increased manufacturing activities related to CTx-1301 following the CRL.

SG&A Expenses: Selling, general and administrative expenses (SG&A) were $4.6 million for the three months ended September 30, 2026, compared to $3.1 million for the three months ended September 30, 2025, an increase of 45.5%. For the nine months ended September 30, 2026, SG&A expenses were $14.2 million, compared to $6.6 million for the nine months ended September 30, 2025, an increase of 116.6%. The increases were driven primarily by the build-out of commercial readiness capabilities, including increased headcount and expanded market access, pricing, reimbursement and medical affairs activity conducted through Indegene, the Company’s commercialization partner.

Net Loss: Net loss was $7.7 million for the three months ended September 30, 2026, compared to $7.3 million for the three months ended September 30, 2025. For the nine months ended September 30, 2026, net loss was $22.9 million, compared to $16.2 million for the nine months ended September 30, 2025. The increases primarily reflect the higher SG&A expenses described above, partially offset in the third quarter by a smaller loss from the change in fair value of derivative and lower interest expense, and for the nine-month period by lower R&D expenses.

Cingulate Inc.
Consolidated Balance Sheet Data
		September 30,				December 31,
			2026				2025
Cash and cash equivalents		$	23,185,900			$	10,953,383
Total assets		$	28,150,677			$	15,073,263
Total liabilities		$	7,383,547			$	12,564,356
Working Capital		$	18,832,234			$	1,695,633
Accumulated deficit		$	(155,288,781	)		$	(132,375,031	)
Total stockholders' equity		$	20,767,130			$	2,508,907

Cingulate Inc.
Consolidated Statements of Operations
		Three Months Ended September 30,								Nine Months Ended September 30,
			2026				2025				2026				2025
Operating expenses:
Research and development		$	2,910,660			$	2,848,544			$	6,581,803			$	7,772,109
Selling, general and administrative			4,580,358				3,147,291				14,247,412				6,579,735
Operating loss			(7,491,018	)			(5,995,835	)			(20,829,215	)			(14,351,844	)
Change in fair value of derivative			(69,323	)			(772,169	)			(1,235,366	)			(1,016,682	)
Interest and other income (expense), net			(171,056	)			(573,058	)			(849,169	)			(808,475	)
Loss before income taxes			(7,731,397	)			(7,341,062	)			(22,913,750	)			(16,177,001	)
Income tax benefit (expense)			-				-				-				-
Net loss			(7,731,397	)			(7,341,062	)			(22,913,750	)			(16,177,001	)

About Attention Deficit/Hyperactivity Disorder (ADHD)

ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.

About CTx-1301

CTx-1301 (dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway. In October 2025, the FDA accepted for review the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. On June 1, 2026, the FDA issued a Complete Response Letter for the CTx-1301 NDA; the Company and its CDMO have since substantially completed the manufacturing work required to address the CMC requests, and the Company expects to resubmit the NDA between December 2026 and January 2026. There can be no assurance regarding the timing of any resubmission or whether approval will occur.

About Precision Timed Release™ (PTR™) Platform Technology

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD.

About Cingulate Inc.

Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, the timing and outcome of any resubmission of the CTx-1301 NDA, market opportunity, competitive position, business strategies, potential growth opportunities, our expected cash runway, and anticipated capital needs and financing plans. These statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of our Annual Report on Form 10-K filed with the SEC on March 18, 2026 and our Quarterly Report on Form 10-Q for the period ended June 30, 2026, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor & Media Relations:

Thomas Dalton

Vice President, Corporate and Government Relations, Cingulate

tdalton@cingulate.com 

(480) 529-5434

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Cingulate expect to resubmit the CTx-1301 application?

Cingulate expects to resubmit the CTx-1301 new drug application between December 2026 and January 2027. Manufacturing work addressing the FDA's information requests is substantially completed, and supporting data and documentation are being finalized.

How much cash does Cingulate have and how long is it expected to last?

Cingulate had approximately $23.2 million in cash and cash equivalents at September 30, 2026, which it believes will fund operations into mid-2027. That outlook includes costs associated with seeking CTx-1301 regulatory approval and continuing to build commercial readiness capabilities.

How long could FDA review take after Cingulate resubmits CTx-1301?

After receiving the resubmission, the FDA is expected to classify it as Class 1 or Class 2, carrying review goals of two months or six months, respectively. The classification has not yet been determined.