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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 4, 2025
CINGULATE INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40874 | 86-3825535 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
| 1901 W. 47th Place | ||||
| Kansas City, KS | 66205 | |||
| (Address of principal executive offices) | (Zip Code) |
(913) 942-2300
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered | ||
| Common Stock, par value $0.0001 per share | CING |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
||
| Warrants, exercisable for one share of common stock | CINGW |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On March 4, 2025, Cingulate Inc. (the “Company”) issued a press release announcing safety results from the final trials for its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity (ADHD), upon approval from the U.S. Food and Drug Administration (FDA). A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item 8.01. Other Events.
On March 4, 2025, the Company announced safety results from the Phase 3 trials for its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD, upon approval from the FDA.
An analysis of the data revealed the following:
| ● | No subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death | |
| ● | There were no clinically relevant trends in TEAEs overall | |
| ● | The pharmacokinetics of the food effect study are being analyzed; however the medical findings are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301 could be taken with or without food |
A final analysis that combines both adult and pediatric safety and efficacy data is expected to be announced mid-2025 and will be included in the NDA submission to the FDA.
As of March 4, 2025, the Company had 3,647,655 shares of its common stock issued and outstanding.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release dated March 4, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CINGULATE INC. | ||
| Dated: March 4, 2025 | By: | /s/ Shane J. Schaffer |
| Name: | Shane J. Schaffer | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025
Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2
CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day
KANSAS CITY, Kan., March 04, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The data readout includes safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study – as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, Cingulate’s highest dosage.
The safety results of these studies have been analyzed and submitted to the FDA in preparation for an in-person Pre-NDA meeting which is scheduled for April 2, 2025. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.
“The safety data from these three studies has been reviewed thoroughly, and we are pleased that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. As we look to bring to the market the first, true, once-daily stimulant medication that treats ADHD over the entire active day, we look forward to our in-person meeting with the FDA next month in preparation for the submission of our new drug application this summer,” said Cingulate Chairman and CEO Shane J. Schaffer.
An analysis of the data revealed the following:
| ● | No subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death | |
| ● | There were no clinically relevant trends in TEAEs overall | |
| ● | The pharmacokinetics of the food effect study are being analyzed; however the medical findings are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301 could be taken with or without food |
“While we have many approved stimulant medications at our disposal as clinicians, booster doses in the morning and/or afternoon are still needed, and these may lead to issues with adherence, efficacy, side effects such as crash and rebound, as well as the potential for abuse and diversion of these short-acting stimulant medications,” stated ADHD expert Ann C. Childress, MD, practicing psychiatrist and recent president of the American Professional Society of ADHD and Related Disorders (APSARD), who has been the lead or primary investigator for all of Cingulate’s Phase 3 clinical trials studying CTx-1301. “Having first-hand experience with Cingulate’s CTx-1301 product, I am excited for both patients and providers to have this treatment option once approved by the FDA to overcome the longstanding unmet needs facing our patients with ADHD.”
About the Phase 3 Children/Adolescent Dose Optimization Study (CTx-1301-004)
| ● | A dose-optimized (doses 6.26mg, 12.5mg, 18.75mg, 25mg, 31.25mg and 37.5mg), randomized, double-blind, placebo-controlled, parallel efficacy and safety laboratory classroom study in children (6-12) with ADHD using CTx-1301 (dexmethylphenidate) | |
| ● | Subjects underwent a screening visit prior to entering the 8-week dose-optimization phase, attended weekly visits and were titrated to doses ranging between 6.25mg-37.5mg | |
| ● | Eligible subjects were randomized to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study | |
| ● | Subjects took their assigned/randomized dose over the following 7-day period. On the 7th days subjects completed the full laboratory classroom study | |
| ● | The duration of the full laboratory classroom study was approximately 15 hours, and subjects had an in-clinic safety follow-up visit within 7 days after the full classroom day |
About the Phase 3 Children/Adolescent Fixed Dose Study (CTx-1301-005)
| ● | A double-blind, randomized, placebo-controlled, multi-center, fixed-dose (doses 18.75mg, 25mg and 37.5mg), parallel-group efficacy and safety study in a pediatric population (6-17) with ADHD |
| ● | The study was comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit |
| ● | The primary endpoint of the trial was mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline (pre-dose) at Visit 2 to ADHD-RS-5 scores at Visit 8 |
| ● | The secondary endpoint was mean change in Clinical Global Impression - Severity (CGI-S) scores within the same time frame. Multiple safety and pharmacokinetic analyses were also measured |
About the Food Effect Study (CTx-1301-013)
| ● | An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study in 26 healthy adult subjects, 18 to 50 years of age | |
| ● | Subjects were randomized into one of two sequences (a fasted state, and a fed state [after a high-fat test meal]) and dosed with a 50mg dose of CTx-1301 | |
| ● | The primary PK endpoints were maximum concentration (expressed as Cmax) during the first 28 hours after dosing, and the total amount of the active pharmaceutical ingredient (API), dexmethylphenidate, in the blood (expressed as the area the plasma drug concentration-time curve [AUC]) from dosing to the time of the last measured concentration (AUC0-last) and from dosing taken to the limit as the end time becomes arbitrarily large (AUC0-∞) |
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., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD.
Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into
adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child
and adolescent segment combined. However, only an estimated 20 percent receive treatment.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough,
multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of
ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain
to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing
challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver
three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is
a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant
products begin to wear off.
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. 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 April 1, 2024 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 & Public Relations:
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
(214) 597-8200