Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Cingulate (NASDAQ: CING) reported Q3 2025 results and corporate updates on Nov 13, 2025.
Key items: the FDA accepted the NDA for CTx-1301 with a PDUFA date of May 31, 2026; positive Phase 3 results were presented at AACAP; a commercial supply agreement with Bend Bio Sciences was executed; a $6.0M financing via a non‑convertible promissory note was completed; and a $4.3M PDUFA fee waiver was granted. As of Sept 30, 2025, cash was $6.1M, working capital $1.55M, and net loss for Q3 was $7.34M. The company projects cash runway into Q2 2026 and plans to raise ~$7.0M to advance commercialization.
Positive
- FDA accepted NDA for CTx-1301 with PDUFA date May 31, 2026
- Positive Phase 3 pivotal results meeting primary endpoint
- Exclusive U.S. commercial supply agreement with Bend Bio Sciences through 2028
- Completed $6.0M financing via 18-month promissory note at 9% interest
- Received $4.3M PDUFA fee waiver under small business provision
Negative
- Cash declined to $6.12M as of September 30, 2025
- Working capital fell to $1.55M from $7.69M year-end 2024
- Company expects to raise ~ $7.0M to reach May 31, 2026 PDUFA
- R&D expenses rose 99.5% to $2.85M for Q3 2025
- Net loss widened to $7.34M in Q3 2025 from $4.13M prior year
News Market Reaction 3 Alerts
On the day this news was published, CING declined 12.37%, reflecting a significant negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $24M at that time.
Data tracked by StockTitan Argus on the day of publication.
Industry Veteran Bryan Downey Named Chief Commercial Officer
NDA Accepted with May 2026 PDUFA Date
Commercial Supply Agreement Executed
KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights.
Recent Highlights (Post-Q3)
FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026
In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to optimize ADHD treatment. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, confirming the NDA is complete and ready for review.
Industry Veteran Bryan Downey Named Chief Commercial Officer;
On November 3, 2025, Cingulate appointed Bryan Downey as Chief Commercial Officer, and announced the completion of a
In conjunction with Downey’s appointment, Cingulate completed a financing transaction with an accredited investor, providing net proceeds of
Positive Phase 3 Results Presented at Annual AACAP Conference
The positive Phase 3 results from Cingulate’s pivotal trial of CTx-1301 were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.
“Cingulate has made meaningful progress this quarter toward key value-creating milestones,” said Jay Roberts, Executive Chairman of Cingulate. “The FDA’s acceptance of our NDA for CTx-1301, the appointment of an experienced commercial leader in Bryan Downey, and the completion of a
Third Quarter Activities:
Commercial Supply Agreement Reached with Bend Bio Sciences
Cingulate announced in September that it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301. Under the new agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if approved by the FDA, and Cingulate has committed to purchasing
In July Cingulate received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the FDA for its NDA for CTx-1301. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save the Company approximately
THIRD QUARTER RESULTS
Cash and Working Capital: As of September 30, 2025, Cingulate had approximately
R&D Expenses: Research and development expenses were
G&A Expenses: G&A expenses were
Net Loss: Net loss was
| Cingulate Inc. | |||||||||
| Consolidated Balance Sheet Data | |||||||||
| September 30, | December 31, | ||||||||
| 2025 | 2024 | ||||||||
| Cash and cash equivalents | $ | 6,118,710 | $ | 12,211,321 | |||||
| Total assets | $ | 10,518,892 | $ | 14,864,489 | |||||
| Total liabilities | $ | 7,045,206 | $ | 7,408,984 | |||||
| Working Capital | $ | 1,551,025 | $ | 7,688,698 | |||||
| Accumulated deficit | $ | (126,102,121 | ) | $ | (109,925,120 | ) | |||
| Total stockholders' equity | $ | 3,473,686 | $ | 7,455,505 | |||||
| Cingulate Inc. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 2,848,544 | $ | 1,428,504 | $ | 7,772,109 | $ | 5,116,582 | ||||||||
| General and administrative | 3,147,291 | 1,853,583 | 6,579,735 | 4,319,902 | ||||||||||||
| Operating loss | (5,995,835 | ) | (3,282,087 | ) | (14,351,844 | ) | (9,436,484 | ) | ||||||||
| Issuance cost and change in fair value of derivative | (772,169 | ) | (894,039 | ) | (1,016,682 | ) | (914,747 | ) | ||||||||
| Interest and other income (expense), net | (573,058 | ) | 50,483 | (808,475 | ) | 22,726 | ||||||||||
| Loss before income taxes | (7,341,062 | ) | (4,125,643 | ) | (16,177,001 | ) | (10,328,505 | ) | ||||||||
| Income tax benefit (expense) | - | - | - | - | ||||||||||||
| Net loss | (7,341,062 | ) | (4,125,643 | ) | (16,177,001 | ) | (10,328,505 | ) | ||||||||
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 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, statements regarding our expected cash runway, anticipated capital needs and financing plans, regulatory timelines for CTx-1301, the potential timing of commercialization of CTx-1301 and manufacturing and supply arrangements. 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 27, 2025 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 Communications, Cingulate
tdalton@cingulate.com
(913) 942-2301
FAQ
What is the PDUFA date for Cingulate's CTx-1301 (NASDAQ: CING)?
How much cash did Cingulate (CING) have at September 30, 2025 and runway expectations?
What financing did Cingulate complete in November 2025 and its terms?
Did Cingulate secure commercial manufacturing for CTx-1301?
What were Cingulate's Q3 2025 operating expense trends affecting investors (CING)?
How much additional capital does Cingulate expect to need before the CTx-1301 PDUFA date?
