KANSAS CITY, Kan., March 18, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. $(CING)$, a biopharmaceutical company utilizing its proprietary Precision Timed Release$(TM)$ (PTR(TM)) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended December 31, 2025, and provided a corporate update. Highlights include recent U.S. and European patent developments, the closing of a $12 million private investment, and the acceptance of a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate HCl).
Cingulate CEO Shane J. Schaffer stated, "Cingulate delivered on key inflection points throughout 2025 and this continues into 2026. Cingulate is proud to announce that CTx-1301 has strengthened its patent estate. We have demonstrated that CTx-1301 utilizing the PTR(TM) Platform does something meaningfully different in the treatment of ADHD, and these improvements are now recognized by patent offices in the United States as well as major territories around the world. We've spent years building the PTR(TM) platform which exclusively delivers medication how and when patients need it most, and we're continuing to work constructively with the FDA as it evaluates our application for approval. While we advance CTx-1301 through the regulatory review process, our Company has strengthened its financial and operational foundation," Schaffer continued. "At the same time, we are advancing our commercial readiness and manufacturing scale-up, so we're well positioned to support commercial launch, pending approval. With the support of our recent financing and the addition of experienced commercial leadership, we believe we're taking the right steps to build long-term value for both patients and shareholders."
Operational Highlights
U.S. Patent Notice of Allowance
On Tuesday, March 17(th) , 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering Cingulate's lead ADHD candidate, CTx-1301, indicating that the agency has completed its examination and determined that the claims are allowable. Upon issuance, the patent is expected to provide protection through May 2042 for key aspects of CTx-1301's formulation and method of use, further strengthening Cingulate's intellectual property portfolio surrounding its Precision Timed Release(TM) (PTR(TM)) platform, which is designed to enable the development of next-generation therapeutics with customized release profiles.
European Patent Granted
Cingulate received a European patent for CTx-1301 covering the specificity of its tri-modal, precision-timed pulsatile release profile for the treatment of ADHD. The patent (EP No. 22808184), granted on December 17, 2025, extends protection through May 2042 and is expected to be validated in more than 30 European territories, including the United Kingdom.
Regulatory
-- In July 2025, Cingulate submitted the New Drug Application (NDA) for
CTx-1301, the Company's lead asset for the treatment of ADHD in children
and adults.
-- In October 2025, the FDA accepted the NDA for review under the 505(b)(2)
regulatory pathway and assigned a Prescription Drug User Fee Act (PDUFA)
target action date of May 31, 2026.
-- The NDA was supported by multiple clinical studies, including Phase 3
clinical trials showing improved ADHD control across multiple metrics in
adult and pediatric patients (ages 6 years and older). Effect size
measurements, the consistency and magnitude of benefit of the product,
were large throughout the day, demonstrating that CTx-1301 provides a
rapid onset of effect and sustained efficacy for a patient's entire
active day, addressing long-standing gaps in ADHD management.
-- As part of the NDA review process, the FDA has requested additional
information related to manufacturing and CMC elements of the application.
The Company is working closely with the Agency to address these requests.
Depending on the timing and scope of these requests and responses, the
FDA may require additional time to evaluate the information provided.
Importantly, to date the requests do not relate to clinical safety or
efficacy findings.
Commercial Readiness Update
The Company continues to advance commercialization preparations, including:
-- Scaling commercial manufacturing -- Advancing market access and payer engagement -- Building commercial leadership and infrastructure -- Preparing distribution and supply chain capabilities
In November, Cingulate appointed Bryan Downey as Chief Commercial Officer. Downey brings extensive commercialization experience, having held senior leadership roles at Alfasigma USA, Jubilant Pharma, and nearly 20 years at Sanofi, where he served as Vice President and Head of the U.S. Cardiovascular and Allergy Business Unit.
Capital Markets Activity
$12 Million At-the-Market PIPE Financing
In February 2026, Cingulate closed a $12 million private investment in public equity $(PIPE)$ financing led by affiliates of Falcon Creek Capital Advisor LLC. The financing was priced at-the-market under Nasdaq rules and included insider participation. All participating investors agreed to a 180-day lock-up, aligning long-term shareholder interests ahead of key regulatory milestones. In connection with the financing, Falcon Creek Capital received the right to designate up to two members to Cingulate's Board of Directors. The first designee is former board member Jeff Hargroves, who was also a significant participant in the offering.
Fourth Quarter and Full Year Results
Cash and Working Capital: As of December 31, 2025, Cingulate had approximately $11.0 million in cash and cash equivalents, a $1.3 million decrease from December 31, 2024. The Company expects current cash on hand will satisfy its capital needs into late fourth quarter of 2026 under the current business plan, which primarily includes activities related to seeking regulatory approval for CTx-1301 and pre-commercialization efforts for CTx-1301.
R&D Expenses: Research and development expenses were $2.0 million for the three months ended December 31, 2025, compared to $4.3 million for the same period in 2024. Research and development expenses were $9.8 million for the year ended December 31, 2025, compared to $9.4 million for the year ended December 31, 2024. This change was primarily the result of an increase in personnel expenses, regulatory costs and manufacturing costs, partially offset by a decrease in clinical operations.
G&A Expenses: General and administrative expenses were $3.6 million for the three months ended December 31, 2025, compared to $1.9 million for the same period in 2024. General and administrative expenses were $10.2 million for the year ended December 31, 2025, compared to $6.2 million for the year ended December 31, 2024. This is primarily the result of an increase in pre-commercialization costs, personnel expenses and legal and professional fees.
Net Loss: Net loss was $6.3 million for the three months ended December 31, 2025, compared to $6.2 million for the three months ended December 31, 2024. Net loss was $22.4 million for the year ended December 31, 2025, compared to $16.6 million for the year ended December 31, 2024. The increase in the net loss primarily relates to increased G&A expenses as described above as well as interest on our notes payable.
Cingulate Inc.
Consolidated Balance Sheet Data
December 31, December 31,
2025 2024
Cash and cash equivalents $ 10,953,383 $ 12,211,321
Total assets $ 15,073,263 $ 14,864,489
Total liabilities $ 12,564,356 $ 7,408,984
Working Capital $ 1,695,633 $ 7,688,698
Accumulated deficit $(132,375,031) $(109,925,120)
Total stockholders' equity $ 2,508,907 $ 7,455,505
Cingulate Inc.
Consolidated Statements of Operations
Three Months Ended
December 31, Year Ended December 31,
2025 2024 2025 2024
Operating
expenses:
Research and
development $ 2,001,948 $ 4,328,683 $ 9,774,057 $ 9,445,265
General and
administrative 3,584,316 1,879,806 10,164,051 6,199,708
---------- ---------- ----------- -----------
Operating loss (5,586,264) (6,208,489) (19,938,108) (15,644,973)
Issuance cost and
change in fair
value of
derivative (133,991) (99,121) (1,150,673) (1,013,868)
Interest and other
income (expense),
net (552,655) 76,510 (1,361,130) 99,236
---------- ---------- ----------- -----------
Loss before income
taxes (6,272,910) (6,231,100) (22,449,911) (16,559,605)
---------- ---------- ----------- -----------
Income tax benefit
(expense) - - - -
Net loss (6,272,910) (6,231,100) (22,449,911) (16,559,605)
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About Attention Deficit/Hyperactivity Disorder $(ADHD)$
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