Cingulate Inc. Reports First Quarter 2026 Financial Results and Provides an Update of Commercial Readiness Efforts On Track for lead ADHD Asset CTx-1301
Rhea-AI Summary
Cingulate (NASDAQ:CING) reported first quarter 2026 results and progress toward commercializing lead ADHD candidate CTx-1301.
Cash and equivalents rose to $25.9 million, with working capital at $17.0 million, aided by a $12.0 million private placement. Management believes this supports operations into 2027 while engaging with the FDA on the CTx-1301 NDA and building AI-augmented commercial and manufacturing capabilities.
Q1 2026 net loss was $9.3 million, driven mainly by higher G&A expenses and non-cash derivative and interest items.
AI-generated analysis. Not financial advice.
Positive
- Cash and equivalents increased to $25.9M, up $14.9M from year-end
- Working capital rose to $17.0M from $1.7M at December 2025
- Completed $12.0M at-the-market private placement in February 2026
- Total stockholders’ equity increased to $18.9M from $2.5M
- Management expects cash runway to fund operations into 2027
- Advancing CTx-1301 NDA review and commercial launch preparations, including IQVIA sales force
Negative
- Q1 2026 net loss widened to $9.3M from $3.9M
- G&A expenses rose to $5.7M from $1.5M year over year
- Change in fair value of derivative was a $0.9M loss
- Interest and other net expense increased to $0.5M from $0.1M
News Market Reaction – CING
On the day this news was published, CING declined 10.77%, reflecting a significant negative market reaction. Argus tracked a trough of -8.9% from its starting point during tracking. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $7M from the company's valuation, bringing the market cap to $60.27M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Ahead of this report, CING was up 2.71%. Several biotech peers like LEXX (+5.68%), ASBP (+5.79%), and CTXR (+6.32%) also traded higher, but scanner data flags this as a stock-specific move rather than a coordinated sector rotation.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 18 | Q4/FY 2025 earnings | Positive | -31.1% | Reported FY 2025 results, NDA acceptance, PDUFA date, and $12M PIPE financing. |
| Nov 13 | Q3 2025 earnings | Positive | -12.4% | Q3 results with NDA acceptance, Phase 3 data, $6M financing, and PDUFA fee waiver. |
| Aug 19 | Q2 2025 earnings | Positive | -9.6% | Q2 results alongside NDA submission and disclosure of cash needs and LPC facility. |
| May 08 | Q1 2025 earnings | Positive | -2.0% | Q1 2025 results, Pre-NDA meeting, grant for CTx-2103, and pipeline updates. |
| Mar 26 | FY 2024 & Q4 earnings | Positive | +5.1% | Full-year 2024 results with improved cash, reduced R&D, and NDA preparation milestones. |
Earnings releases have often been followed by negative moves, even when updates highlighted progress on CTx-1301 and liquidity improvements.
Over the past year, Cingulate’s earnings updates have consistently tied financials to progress on lead ADHD asset CTx-1301. Cash has ranged from $6.1M to $12.2M and $11.0M at prior checkpoints, with working capital generally tight and net losses elevated. Despite milestones such as NDA submission, FDA acceptance, and a May 31, 2026 PDUFA date, earnings-day reactions were often negative. Today’s Q1 2026 update extends that story with a much stronger cash and working capital position.
Historical Comparison
Past earnings headlines saw an average move of about -9.99%, often skewing negative despite operational progress, so a modestly positive reaction here would be a relative improvement.
Earnings updates have tracked CTx-1301 from NDA preparation in 2024 through submission and FDA acceptance in 2025, to the current phase with a May 31, 2026 PDUFA date and markedly stronger cash and working capital supporting commercialization plans.
Regulatory & Risk Context
An active S-3/A shelf amendment dated March 23, 2026 is in place, with the registration effective and at least 3 related prospectus supplements (424B3) filed in March–April 2026, indicating ongoing use of registered securities for financing.
Market Pulse Summary
The stock dropped -10.8% in the session following this news. A negative reaction despite balance sheet improvement would fit prior earnings patterns, where average post-report moves were about -9.99% even alongside NDA and commercialization progress. The widened Q1 net loss of $9.3M and higher G&A tied to launch build-out could exacerbate downside. Continued use of registered offerings and financing tools may add pressure if sentiment weakens after regulatory or commercial updates.
Key Terms
precision timed release medical
adhd medical
new drug application regulatory
cmc regulatory
at-the-market private placement financial
AI-generated analysis. Not financial advice.
Cash Position Grows to
KANSAS CITY, Kan., May 14, 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 March 31, 2026, and provided a corporate update.
“Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market,” said Cingulate CEO Shane J. Schaffer. “We continue to engage constructively with the FDA on our new drug application while advancing commercial readiness and manufacturing capabilities, and believe our current resources provide an extended cash runway into 2027.”
Strengthened Balance Sheet
Cingulate enters the second quarter of 2026 with a meaningfully stronger financial position, having grown its cash and cash equivalents to
Regulatory Update
Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and CMC elements of its CTx-1301 NDA. The Company remains committed to working efficiently with the Agency and will provide updates as the review process progresses.
Commercial Readiness Update
Cingulate continues to advance its commercialization preparations, with dedicated teams established across all key functional areas. The Company’s launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement — positioning Cingulate for a rapid commercial launch contingent upon FDA approval. Key areas of focus include:
- Market Access and Payer Engagement: Advancing payer strategy and reimbursement frameworks
- Distribution and Supply Chain: Preparing distribution infrastructure and supply chain capabilities
- Omnichannel Infrastructure: Deploying a comprehensive AI-augmented marketing technology to support targeting and performance optimization across channels
- Commercial Manufacturing: Scaling manufacturing operations and advancing process validation batch preparation for CTx-1301, which will serve as launch inventory if approved
- Field Force Optimization: Building out Cingulate’s sales team through an agreement with IQVIA Inc. for deployment upon potential FDA approval
First Quarter Results
Cash and Working Capital: As of March 31, 2026, Cingulate had approximately
R&D Expenses: R&D expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
| Cingulate Inc. | ||||||||
| Consolidated Balance Sheet Data | ||||||||
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Cash and cash equivalents | $ | 25,893,210 | $ | 10,953,383 | ||||
| Total assets | $ | 30,861,701 | $ | 15,073,263 | ||||
| Total liabilities | $ | 11,996,835 | $ | 12,564,356 | ||||
| Working Capital | $ | 16,952,085 | $ | 1,695,633 | ||||
| Accumulated deficit | $ | (141,687,120 | ) | $ | (132,375,031 | ) | ||
| Total stockholders' equity | $ | 18,864,866 | $ | 2,508,907 | ||||
| Cingulate Inc. | ||||||||
| Consolidated Statements of Operations | ||||||||
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 2,184,318 | $ | 2,222,626 | ||||
| General and administrative | 5,738,904 | 1,483,409 | ||||||
| Operating loss | (7,923,222 | ) | (3,706,035 | ) | ||||
| Change in fair value of derivative | (852,030 | ) | (49,987 | ) | ||||
| Interest and other income (expense), net | (536,837 | ) | (96,656 | ) | ||||
| Loss before income taxes | (9,312,089 | ) | (3,852,678 | ) | ||||
| Income tax benefit (expense) | - | - | ||||||
| Net loss | (9,312,089 | ) | (3,852,678 | ) | ||||
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 HCI) 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, Cingulate announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for CTx-1301 and had assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the FDA has determined the submission is sufficiently complete to permit substantive review. NDA acceptance does not imply approval, nor does it guarantee any specific outcome or timing.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
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, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, the timing and process for regulatory approval of CTx-1301 and the potential timing of commercialization of CTx-1301, if approved, our progress with commercial readiness and manufacturing scale-up activities, statements regarding 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 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
