Financial Performance - Operating loss for the three months ended September 30, 2024, was $3,282,087, a decrease from $5,749,674 for the same period in 2023[10] - Net loss for the three months ended September 30, 2024, was $3,231,604, compared to a net loss of $5,979,054 for the same period in 2023[10] - The net loss for the three months ended September 30, 2023, was $5,979,054, compared to a net loss of $16,600,250 for the nine months ended September 30, 2023[16] - The company incurred a net loss of $9,413,758 for the nine months ended September 30, 2024, compared to $16,600,250 for the same period in the previous year[16] - The accumulated deficit increased to $(102,357,201) as of September 30, 2024, from $(92,943,443) on December 31, 2023, reflecting a rise of approximately 10%[8] - The company reported a net cash used in operating activities of $14,371,857 for the nine months ended September 30, 2024[16] - The company reported interest and other income of $50,483 for the three months ended September 30, 2024, compared to an expense of $(229,380) in the same period of 2023, indicating a positive shift[10] Assets and Liabilities - Total current assets increased significantly to $11,343,611 as of September 30, 2024, compared to $578,594 at the end of December 31, 2023[8] - Cash and cash equivalents decreased to $10,040,149 as of September 30, 2024, from $52,416 at the end of December 31, 2023[8] - Total liabilities decreased to $1,542,541 as of September 30, 2024, from $10,360,865 at the end of December 31, 2023[8] - Total stockholders' equity increased to $12,037,563 as of September 30, 2024, from a deficit of $(6,869,429) at the end of December 31, 2023[8] - Accrued expenses totaled $402,152 as of September 30, 2024, significantly down from $1,651,518 as of December 31, 2023, reflecting a decrease of approximately 75.7%[30] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $5,116,582, down from $10,508,395 in the same period of 2023[10] - Research and development expenses for the three months ended September 30, 2024, were $1,428,504, down from $3,923,852 in the same period of 2023, reflecting a decrease of about 64%[10] - The company plans to develop and commercialize product candidates, with ongoing clinical trials for CTx-1301, CTx-1302, and CTx-2103[6] - The company is targeting a New Drug Application (NDA) for its ADHD treatment CTx-1301 in mid-2025, with ongoing clinical requirements[18] - The company has a third product, CTx-2103, in the formulation stage for treating anxiety[18] Stock and Financing - The company raised approximately $24.4 million from the issuance of common stock and pre-funded common stock purchase warrants during the nine months ended September 30, 2024[16] - The company issued common stock in connection with various offerings, raising a total of approximately $11,791,624 during the three months ended September 30, 2024[14] - The Company completed a public offering on February 2, 2024, resulting in gross proceeds of $7.5 million before deducting $750,950 in fees[51] - The Company sold 902,300 shares of common stock under the ATM Agreement for net proceeds of $5,804,393 during the three months ended September 30, 2024[48] - The Company sold 1,092,337 shares under the Lincoln Park Purchase Agreement during the three months ended September 30, 2024, for net proceeds of $6,081,814[50] Stock-Based Compensation - Stock-based compensation expense for the three months ended September 30, 2023, was $236,251[13] - Stock-based compensation expense was recorded at $812,691 for the nine months ended September 30, 2024, compared to $658,105 for the same period in 2023[56] - The fair value of stock options granted during the three months ended September 30, 2024, was $5.04, while the range for the nine months ended September 30, 2024, was from $4.00 to $14.00[61] - As of September 30, 2024, there was $1,219,737 of unrecognized compensation cost related to nonvested share-based compensation arrangements, expected to be recognized over the next one to four years[56] Tax and Valuation - The Company recorded a valuation allowance for deferred tax assets totaling $16,121,058 as of September 30, 2024, compared to $12,631,033 at December 31, 2023[74] - No deferred income tax benefit or expense was recorded for the three-month periods ended September 30, 2024 and 2023, or for the nine-month periods ended September 30, 2024 and 2023[71] - The total income tax expense for the nine months ended September 30, 2024, was $0, consistent with the previous year[72] - The Company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of September 30, 2024[76] Corporate Actions - The company completed a one-for-twelve reverse stock split on August 9, 2024, reducing the number of issued and outstanding shares[41] - The Company has authorized 240,000,000 shares of common stock and 10,000,000 shares of preferred stock, with 3,044,165 shares of common stock issued and outstanding as of September 30, 2024[38] - The maximum aggregate offering price of shares under the ATM Agreement was increased from $15.2 million to $19.7 million[78] - The Company approved an amendment to the 2021 Plan, increasing the number of shares authorized for issuance by 104,167 shares to a total of 125,577 shares[55]

Financial Results Announcement - Cingulate Inc. announced its financial results for the quarter ended September 30, 2024, on November 7, 2024[3]. - The press release detailing the financial results is included as Exhibit 99.1[3]. - The report does not include specific financial metrics or performance indicators in the provided content[3]. - No information on user data, future outlook, or guidance was disclosed in the available documents[3]. Company Classification and Status - The company is classified as an emerging growth company[2]. - The company has not elected to use the extended transition period for new financial accounting standards[2]. Corporate Information - The report was signed by Jennifer L. Callahan, Chief Financial Officer[5]. - The address of the principal executive offices is 1901 W. 47 Place, Kansas City, KS 66205[1]. - The company’s common stock is traded on the Nasdaq Capital Market under the symbol CING[1]. Product and Market Information - There are no mentions of new products, technologies, market expansion, or acquisitions in the provided content[3].

Core Insights - Cingulate Inc. is focused on developing its lead Phase 3 asset CTx-1301 for ADHD treatment and exploring commercialization plans [1][3] - The company utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform to create next-generation pharmaceutical products [1][3] - Cingulate is also evaluating additional therapeutic areas for its PTR technology, including anxiety disorders [3] Company Overview - Cingulate Inc. is a clinical-stage biopharmaceutical company headquartered in Kansas City [3] - The company aims to improve treatment outcomes for patients with conditions that require burdensome daily dosing regimens [3] - Cingulate's initial focus is on Attention Deficit/Hyperactivity Disorder (ADHD) [3]

As filed with the Securities and Exchange Commission on October 3, 2024 Registration No. 333-282358 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) Delaware 2834 86-3825535 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1901 W. 47th Place K ...

As filed with the Securities and Exchange Commission on September 26, 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) Delaware 2834 86-3825535 (Primary Standard Industrial Classification Code Number) If this Form is filed to register additional securities for an ...

Core Insights - Cingulate Inc. has initiated its final FDA-required food effect study for CTx-1301, a treatment for ADHD, with data expected by the end of 2024 [1][3] - The company has raised over $10 million in capital since mid-August 2024, with 58% from its at-the-market facility, and is now compliant with Nasdaq listing requirements [2] - Cingulate aims to submit a New Drug Application (NDA) for CTx-1301 by mid-2025 [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 [8] - The company is headquartered in Kansas City and is initially concentrating on ADHD treatment while exploring additional therapeutic areas such as anxiety disorders [8] Product Details - CTx-1301 is designed to provide a multi-core formulation of dexmethylphenidate, aiming for a rapid onset and full-day efficacy in ADHD treatment [6] - The drug delivery platform incorporates an Erosion Barrier Layer (EBL) to control drug release at precise times, enhancing patient care [7] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with about 80% receiving treatment [5] - Adult ADHD prevalence is estimated at around 11 million patients, with only 20% receiving treatment [5]

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]