Core Viewpoint - Cingulate Inc. has adjourned its Special Meeting of Stockholders to allow more time for stockholders to vote on proposals due to insufficient quorum [1][2]. Company Overview - Cingulate Inc. is a biopharmaceutical company that utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products aimed at improving treatment outcomes for patients with conditions requiring frequent dosing [5]. Special Meeting Details - The adjourned Special Meeting will take place on August 28, 2024, at 11:00 a.m. Central Time, accessible via www.meetnow.global/MCZZ4DG [3][4]. - The record date for the Special Meeting is June 28, 2024 [3]. - The Board of Directors recommends that stockholders vote FOR all proposals on the agenda [4].

As filed with the Securities and Exchange Commission on August 19, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CINGULATE INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3825535 (I.R.S. Employer Identification Number) 1901 W. 47th Place Kansas ...

Core Insights - Cingulate Inc. has been granted a European patent for its lead asset CTx-1301, aimed at treating Attention Deficit Hyperactivity Disorder (ADHD) [1][2][3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][7] - The company is headquartered in Kansas City and aims to improve treatment outcomes for conditions requiring complex dosing regimens [7][8] Product Details - CTx-1301 utilizes the PTR platform to deliver dexmethylphenidate, a compound approved for ADHD treatment, in a multi-core formulation designed for optimal patient care [5][6] - The product aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [5] Market Potential - The ADHD market is significant, with approximately 6.4 million children and adolescents diagnosed in the U.S., and an estimated 11 million adults affected, indicating a large potential patient base for CTx-1301 [4] - The company is looking to expand its reach into European markets and other territories, highlighting the growing demand for ADHD treatments [3][4] Patent and Regulatory Strategy - The European patent, EP Patent No. 3261625, covers up to 30 territories, including the UK, and complements existing patents in Australia, Canada, and Israel, with pending applications in other regions [2][3] - Cingulate plans to file a new drug application with the FDA as it continues to demonstrate the clinical success of CTx-1301 [3]

Financial Performance - Research and development expenses for Q2 2024 were $1,881,093, compared to $4,455,927 in Q2 2023, reflecting a decrease of approximately 58.7%[7] - General and administrative expenses for Q2 2024 were $1,325,087, down from $1,906,442 in Q2 2023, a reduction of about 30.4%[7] - The operating loss for the six months ended June 30, 2024, was $6,154,397, compared to $10,212,364 for the same period in 2023, indicating an improvement of approximately 39.9%[7] - The net loss for Q2 2024 was $3,209,677, compared to $6,616,309 in Q2 2023, representing a decrease of about 51.6%[7] - The company reported a net loss of $6,182,154 for the six months ended June 30, 2024, compared to a net loss of $10,621,196 for the same period in 2023, indicating a 42.9% improvement in losses year-over-year[9] - The company incurred an operating loss of $3,206,180 for the three months ended June 30, 2024, compared to an operating loss of $6,362,369 for the same period in 2023, indicating a 50% reduction in operating losses[7] - The company reported a net loss per share of $5.47 for Q2 2024, compared to $6.79 for Q2 2023, showing a reduction in loss per share[7] - For the three months ended June 30, 2024, the company reported a net loss of $3,209,677, compared to a net loss of $6,616,309 for the same period in 2023, representing a 51% improvement[7] Cash Flow and Funding - The company had cash and cash equivalents of approximately $0.4 million as of June 30, 2024, with an accumulated deficit of approximately $99.1 million[12] - Net cash used in operating activities was $10,488,400 for the six months ended June 30, 2024, compared to $8,180,207 for the same period in 2023, reflecting a 28.2% increase in cash outflow[9] - Cingulate Inc. raised $10,979,443 from the issuance of common stock and pre-funded common stock purchase warrants during the financing activities[9] - The company raised approximately $1.6 million from a warrant inducement that closed on July 1, 2024, but will require additional funding for operations and development[12] - The company is exploring various strategies for additional funding, including equity offerings and potential collaborations, to support ongoing operations and development[12] Shareholder Information - The weighted average number of shares used in computing net loss per share for Q2 2024 was 586,313, compared to 974,569 for Q2 2023[7] - The Company authorized 240,000,000 shares of common stock and 10,000,000 shares of preferred stock, with 780,762 shares of common stock issued and outstanding as of June 30, 2024[27] - The Company completed a one-for-twenty reverse stock split on November 30, 2023, and a one-for-twelve reverse stock split on August 9, 2024, affecting the number of issued and outstanding shares[29][31] - Under the At-the-Market Agreement, the Company sold 23,650 shares for net proceeds of $3,115,284 in Q1 2024 and 31,858 shares for $354,259 in Q2 2024[32][35] - The Company raised $7.5 million in gross proceeds from a public offering on February 2, 2024, after deducting $750,950 in fees[36] Product Development - The company plans to develop and commercialize product candidates CTx-1301, CTx-1302, and CTx-2103, with timelines for clinical trials and NDA submissions yet to be determined[4] - The company is targeting a New Drug Application (NDA) for its ADHD treatment CTx-1301 in the first half of 2025, with ongoing clinical requirements being addressed[10] - Cingulate Inc. is actively seeking additional product candidates with significant commercial potential to align with its strategic objectives[4] - Cingulate is developing two proprietary stimulant medications, CTx-1301 and CTx-1302, aimed at treating ADHD across all patient segments[10] Expenses and Liabilities - The total accrued expenses decreased significantly to $383,313 as of June 30, 2024, from $1,651,518 at the end of 2023, indicating a reduction of 76.8%[20] - The company incurred depreciation expenses of $327,381 for the six months ended June 30, 2024, compared to $255,930 for the same period in 2023, representing a 28% increase[19] - The company recorded stock-based compensation expense of $418,906 for the six months ended June 30, 2024, compared to $421,853 for the same period in 2023, reflecting a slight decrease[41] - Cingulate's stock-based compensation expense for the six months ended June 30, 2024, was $541,349, compared to $421,855 for the same period in 2023, reflecting a 28.4% increase[9] Tax and Valuation - The Company recorded a valuation allowance of its net deferred tax assets totaling $14,270,572 as of June 30, 2024, compared to $12,631,033 at December 31, 2023[53] - The company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of June 30, 2024[54] - No deferred income tax benefit or expense was recorded for the three-month and six-month periods ended June 30, 2024, and 2023[51]

Exhibit 99.1 Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity Continues KANSAS CITY, Kan., August 13, 2024 -- 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, toda ...

FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity Continues KANSAS CITY, Kan., Aug. 13, 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 June 30, 2024, and provided a clinical and business up ...

KANSAS CITY, Kan., June 28, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (the "Company") (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 the entry into definitive agreements for the immediate exercise of certain outstanding Series A warrants to purchase up to an aggregate of 2,125,000 shares of common stock of the Company and Series B ...

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered Series C warrants to purchase up to 4,250,000 shares of common stock and new unregistered Series D warrants to purchase up to 2,125,000 shares of common stock. The new warrants will have an exercise price of $0.585 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants. The Series C warrants w ...

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 ...

Core Insights - Cingulate Inc. is participating in a live event to discuss ADHD unmet needs, Phase 3 study results, and potential expansion of its PTR platform [2][5] - The company focuses on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) technology [6] Company Overview - Cingulate Inc. is a clinical-stage biopharmaceutical company headquartered in Kansas City, utilizing PTR technology to improve treatment outcomes for conditions like ADHD [6] - The company aims to identify additional therapeutic areas for its PTR technology, including anxiety disorders [6] Key Personnel - Dr. Ann Childress, a board-certified psychiatrist and scientific advisor for Cingulate, has been with the company since 2018 and has led significant clinical studies [4][7] - Dr. Childress has extensive experience in psychiatric research, having conducted over 180 clinical studies on major psychiatric drugs [7][9]