KANSAS CITY, Kan., June 25, 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, PharmD, and preeminent board-certified psychiatrist and Cingulate scientific advisor Dr. Ann Childress, MD, will participate in a live Benzinga All Access event on June 26, 20 ...

The event may be viewed live on Benzinga's YouTube channel, Benzinga All Access, and will also be available for viewing on Cingulate's website at cingulate.com/investors. The discussion will address the current unmet needs in Attention Deficit/Hyperactivity Disorder (ADHD), a review of the results from Cingulate's Phase 3 Fixed-Dose Study in pediatrics and adolescents, and the potential expansion of Cingulate's PTR platform into other therapeutic areas. Dr. Schaffer will also provide a company overview. Abo ...

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 ...

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 ...

Financial Performance - The company reported a net loss of $2,972,477 for the three months ended March 31, 2024, an improvement from a net loss of $4,004,887 for the same period in 2023[62] - For the three months ended March 31, 2024, the company reported a net loss of $2,972,477, compared to a net loss of $4,004,887 for the same period in 2023, representing a 25.7% improvement[81] - Cingulate Inc. reported a net loss of $2,972,477 for Q1 2024, a decrease of 25.7% compared to a net loss of $4,004,887 in Q1 2023[80] - The company reported net cash used in operating activities of $(8,746,360) for the three months ended March 31, 2024, compared to $(3,576,461) for the same period in 2023[62] - The company has incurred losses and negative cash flows from operations since inception, indicating a need for additional funding to support operations and development[89] Assets and Liabilities - Total current assets increased to $2,726,842 as of March 31, 2024, compared to $578,594 as of December 31, 2023, representing a significant growth[45] - Total liabilities decreased to $2,278,396 as of March 31, 2024, down from $10,360,865 as of December 31, 2023[45] - Stockholders' equity improved to $3,216,119 as of March 31, 2024, compared to a deficit of $(6,869,429) at the end of 2023[45] - Total current liabilities decreased significantly to $2,245,251 as of March 31, 2024, from $10,225,766 as of December 31, 2023[45] - As of March 31, 2024, the company's accumulated deficit stood at $95,915,920, reflecting ongoing financial challenges[83] Cash and Financing - Cash and cash equivalents surged to $1,113,830 as of March 31, 2024, up from $52,416 at the end of 2023[45] - The company had cash and cash equivalents of $1,113,830 as of March 31, 2024, down from $1,738,760 at the end of Q1 2023, indicating a decrease of 36%[86] - The company received $5.0 million in debt financing in August 2022 and an additional $3.0 million in May 2023, increasing the total principal amount to $8.0 million[74] - The company is evaluating various strategies to obtain additional funding, which may include equity offerings, debt issuance, or strategic collaborations[89] - The company raised approximately $7.5 million in gross proceeds from a public offering completed in February 2024[103] Research and Development - Cingulate is developing two proprietary medications for ADHD, CTx-1301 and CTx-1302, utilizing a flexible core tableting technology[64] - The company plans to submit a New Drug Application (NDA) for CTx-1301 in the first half of 2025, following the closure of enrollment in Phase 3 clinical trials[64] - Cingulate Inc. closed enrollment for Phase 3 clinical trials for CTx-1301, which targets ADHD treatment[64] - Research and development expenses decreased to $1,806,985 in Q1 2024 from $2,128,616 in Q1 2023, a reduction of approximately 15.1%[81] - Research and development expenses for Q1 2024 were $1,806,985, down 15.1% from $2,128,616 in Q1 2023[80] Stock and Equity - The company issued 3,552,000 shares in a public offering, netting $6,432,892 after fees[60] - The company completed a one-for-twenty reverse stock split on November 30, 2023, which reduced the number of shares issued and outstanding[77] - The company has a total of 6,046,479 shares of common stock issued and outstanding as of May 3, 2024[52] - The Company issued Series A and Series B warrants in the February 2024 Offering, with Series A warrants having an exercise price of $2.00 and a five-year term[111] - The Company issued Series A warrants for 3,750,000 shares and Series B warrants for 1,875,000 shares at an exercise price of $2.00 per share[111] Tax and Expenses - The company recognized $31,250 in interest expense related to a related party note for Q1 2024, down from $187,500 in Q1 2023, a reduction of 83.4%[76] - The federal income tax benefit for the three months ended March 31, 2024, was $(588,266), compared to $(841,026) for the same period in 2023[116] - The state income tax benefit for the same period was $(154,910), down from $(221,470) in the prior year[116] - The Company recorded a change in valuation allowance of $770,439 for the three months ended March 31, 2024[116] - The Company recorded stock-based compensation expenses of $164,575 for the three months ended March 31, 2024, compared to $204,479 for the same period in 2023[105]

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 ...