Financial Performance - Cingulate Inc. reported a net loss of $15.5 million for the year ended December 31, 2024, a decrease from a net loss of $23.5 million in 2023[10] - Research and development expenses were $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities[10] - Working capital increased by $17.2 million to approximately $7.5 million as of December 31, 2024, compared to a negative working capital of $9.6 million in 2023[7] - Cash and cash equivalents rose to approximately $12.2 million as of December 31, 2024, a significant increase of $12.1 million from the previous year[9] - Cingulate raised $9.4 million from a common stock offering and $8 million from a purchase agreement in 2024, strengthening its financial position[5] Product Development - Cingulate is on track for a New Drug Application (NDA) submission for CTx-1301 in mid-2025, following a scheduled pre-NDA meeting with the FDA on April 2, 2025[3] - Safety data from two Phase 3 studies for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials[3] - The company completed its final FDA-required study in January 2025, confirming that CTx-1301 can be taken with or without food[5] - Cingulate holds a European patent for CTx-1301, granted on August 14, 2024, covering up to 30 territories, including the UK[5] Strategic Initiatives - The company continues to explore licensing agreements and market expansion opportunities both domestically and internationally[5]

Core Insights - Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication aimed at treating ADHD, with no serious adverse events reported [2][3][4] - The company plans to submit a New Drug Application (NDA) to the FDA by mid-2025, marking a significant milestone in the development of CTx-1301 [4] 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 [2][12] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD [12] Product Development - CTx-1301 is designed to be a once-daily stimulant medication that provides effective treatment for ADHD throughout the day, regardless of food intake [4][10] - The drug utilizes a multi-core formulation of dexmethylphenidate, which is part of the stimulant class of medications known for their efficacy in treating ADHD [9][10] Study Details - The food effect study involved administering a single 50mg dose of CTx-1301 to subjects in both fed and fasted states, with results expected in Q2 2025 [3][9] - Previous studies indicated that CTx-1301 could be taken with or without food, demonstrating its versatility [3] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [8] - The adult ADHD population is estimated at around 11 million, with only about 20% receiving treatment [8] Technology Platform - Cingulate's PTR technology allows for precise control of drug release, aiming to enhance patient care by providing a tailored dosing experience [11] - The platform is designed to deliver medication at specific intervals, improving upon existing therapies for ADHD and potentially other conditions [11]

Company Overview - Cingulate Inc. (NASDAQ:CING) is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology [2][7] - The company aims to improve treatment outcomes for patients with conditions that require burdensome daily dosing regimens, initially focusing on ADHD and exploring additional therapeutic areas such as anxiety disorders [2] Financial Transaction - Cingulate has completed a financing transaction with an accredited investor, resulting in net proceeds of $5 million [7] - The transaction involved a non-convertible, unsecured promissory note with a principal amount of $5,480,000, accruing interest at a rate of 9% per annum and maturing 18 months after issuance [7] Use of Proceeds - The net proceeds from the financing will be utilized for working capital and general corporate purposes, providing the company with a cash runway to fund clinical, manufacturing, and regulatory activities, as well as operating costs into the fourth quarter of 2025 [3] - The company plans to file a New Drug Application (NDA) for potential FDA approval of CTx-1301, targeting mid-2025 for this filing [3]

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]

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].

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]