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]

Core Insights - Cingulate Inc. has completed the manufacturing of twelve registration batches for its lead asset CTx-1301, which is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [9][10] - The company is preparing to submit a New Drug Application (NDA) for CTx-1301, with expectations to file in the first half of 2025 [2] - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release (PTR) drug delivery platform, designed to optimize medication release for ADHD treatment [4][5] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its PTR drug delivery technology [9][14] - The company is headquartered in Kansas City and is publicly traded on NASDAQ under the ticker symbol CING [15] Product Details - CTx-1301 is a multi-core formulation of dexmethylphenidate, a compound approved for ADHD treatment, designed to provide a full-day efficacy with precise medication release [4][5] - The PTR platform incorporates an Erosion Barrier Layer (EBL) that controls drug release at specific times, enhancing patient care by minimizing the need for multiple daily doses [5][6] Market Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [3] - The adult ADHD population is estimated at around 11 million, indicating a substantial market opportunity for effective treatment options [3]

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]