On
March 17, 2026 the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application for its lead
asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). When granted, patent protection
will extend through May 2042.
Exhibit
99.1
Cingulate
Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights
U.S.
Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted
Recent
$12M Private Placement Closed At-the-Market Pricing
KANSAS
CITY, Kan., March 18, 2026 -- 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 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™ 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™ 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 17th, 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™ (PTR™) 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 patients 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 | ) |
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
