Twelve Required Registration Batches Completed New Drug Application Being Prepped for Submission About Attention Deficit/Hyperactivity Disorder (ADHD) 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 ...

Twelve Required Registration Batches Completed New Drug Application Being Prepped for Submission Registration batches are required by the U.S. Food and Drug Administration (FDA) to be manufactured before submitting a new drug application (NDA) using the actual equipment, dosage strengths and procedures that will be used to commercialize the drug product candidate. Cingulate, which recently announced it had received confirmation from and agrees with the FDA on the requirements necessary for filing an NDA for ...

As of March 31, 2024, we had cash and cash equivalents of $1.1 million. We believe our cash will satisfy our capital needs through late in the second quarter of 2024 under our current business plan. In addition, in order to achieve the filing of our NDA for CTx-1301 in the first half of 2025 for potential FDA approval, we believe that we will need approximately $11-13 million of additional capital, which is an increase of approximately $2 million from the previously disclosed amount. This increase is relate ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Date of Report (Date of earliest event reported): May 8, 2024 (Exact name of registrant as specified in its charter) 1901 W. 47 Place Kansas City, KS 66205 (Address of principal executive of ices) (Zip Code) (Former name or former address, if changed since last report.) ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Ex ...

CTx-1301 on track to file for Marketing Approval with FDA in 1H 2025 Increase of $10 Million in Stockholders' Equity KANSAS CITY, Kan., May 08, 2024 (GLOBE NEWSWIRE) -- 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 announced its financial results for the three months ended March 31, 2024, and provided a clinical and busines ...

KANSAS CITY, Kan., April 30, 2024 (GLOBE NEWSWIRE) -- 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 announced that longstanding Cingulate investor and board member Peter J. Werth will join Cingulate Chairman and CEO Shane J. Schaffer in a live Benzinga All Access event on Friday May 3, 2024, at 12:10 p.m. EST. Mr. Werth, Fou ...

KANSAS CITY, Kan., April 16, 2024 (GLOBE NEWSWIRE) -- 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 announced that it will present at the Planet MicroCap Showcase: VEGAS 2024 conference on Wednesday, May 1, 2024, at 2:30 PM PST. Management will also host individual investor meetings on Thursday, May 2. Meetings will be condu ...

FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-40874 Delaware 86-3825535 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1901 W. 47 Place Kansas City, KS 66205 (Address of principal executive offices) (Zip Code) Securities registered pursuant to Section 12(b) of the Act: Securities register ...

In February 2024, Cingulate appointed three independent directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin. Please visit Cingulate.com for more information about the new directors. Fourth Quarter and Full Year Results Exhibit 99.1 Since January 1, 2024, the Company sold shares of common stock under its At the Market Offering Agreement with H.C. Wainwright & Co., LLC for gross proceeds of $3.2 million. In February 2024, the Company closed a $7.5 million public offering of its common stock (o ...

KANSAS CITY, Kan., March 19, 2024 (GLOBE NEWSWIRE) -- 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 announced that Chairman and CEO Shane J. Schaffer will participate in a live Benzinga All Access event on Friday March 22, 2024, at 12 p.m. ET. The discussion will focus on Cingulate's pipeline and product portfolio, including ...